Like many things, like doctors, computer security, and safety maintenance, government often fades into the background when it works, while being a blistering sore when it doesn’t. Building codes for safety, road planning and construction to reduce fatalities, food producer and preparation regulation to reduce illness, the entire criminal court system, the EPA (notice the sky in cities is. Not dark grey anymore), commercial law, etc. these all work pretty well! And for the lauded efficiency of corporations - people inside those constantly complain about inefficiency and stupidity as well. I’m not critiquing public choice economics or anything, just pointing out that the government often works okay, even if often it does not, and is certainly not a failure. The “government” has solved thousands of your problems.
Not sure about that! The marginal benefit minus marginal cost of a govt dollar or employee or whatever is different between welfare slash wealth redistribution slash poverty remediation and military spending and fda spending and say irs spending (which needs increasing!). I don’t see at all why “the benefit of government is exceeded by the cost” is true as a whole when we can instead say some parts should be expanded and others contracted much of the larger government is, in fact, good - the EPA is pretty nice, and arguably has too little power (well, in some areas, and not in others). Government size is a terrible metric for what should’ve been actual substantiative reforms. Otherwise you’ll get more IRS cuts (thanks Republicans striking that from the infrastructure bill compromise iirc) and cuts for enforcement of important regulatory codes and no changes in money for poor people cuts which is what you want I believe
Even under such a system corporate and rich people still have extremely structurally complicated finances where a lot of the income could be located in different areas and so we will still need tax enforcement. Additionally, finance is complicated and and reforms would surely still be. I’m not opposing tax reform but it’s been tried a lot and the irs would still need funding.
I’m more or less happy that the EPA has moved the goalposts as we’ve found that lots of contaminants that are less obvious are full quite harmful, and suspect that we have much less environmental enforcement in the way of chemical pollution than we need, although we have overreach as well in some areas. I don’t think defunding is the answer, especially if pollutants are still decreasing (and maybe they’ve been replaced by new ones?)
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That seems to indicate that Scott would need to report this user but maybe anyone could do it too.
Countering spam, and security more generally, is really hard. And anything you make to do that can itself be 'weaponized'.
That said, I think these comments are the first spam I've seen on any 'newsletter' on Substack so far, which might, if anything, demonstrate that they _are_ pretty "professional" in this regard.
I think this combination antiviral, antibacterial, antifungal, anticancer, neuroprotecrive, antiparasitic, thrombolytic, anticonvulsant, antihypertensive miracle herbal preparation needs rapid investigation, multiple large trials, breakthrough status, and most of all right for any doctor to prescribe (with informed consent of course) to anyone who needs it.
But here we have a patient's testimonial that the natural herbs of Dr. Ogu cure everything from epilepsy to AIDS, what more evidence do you need before licencing it? What are you, some FDA bureaucrat? 🤣
Strict? lax? fast? slow? is not the point. FDA does not use cost benefit analysis in it's approval process. Which would not be bad except that nether do doctors or insurance companies including Medicare.
I think it sort of does, informally, to some degree? This is kind of what some of the fast-tracking programs are - given that this drug is really important, we'll let it through a little faster.
I agree a formal cost-benefit analysis would be better. I genuinely don't know to what degree the FDA does this. And I suspect if you asked them to, it would just be one more six-month-long $100 million piece of paperwork they would have to do before they approved anything.
To the extent that you can get approved for reducing things like hospitalizations it uses cost benefit and they talk about risk benefit a lot but they are garbage at the latter. I don't think price should go into the FDAs decision at all. But insurers need to prioritize cost benefit and make that the core of their decision making. The FDA should really say is it safe? If so allow people to take it/prescribe it. Is it effective? If so allow drug company to advertise it.
There should be room for things that are safe but we don't know much else and people can roll the dice and pay out of pocket for that or choose an expensive insurer who'll cover anything. That's basically how we treat supplements. FDA is like airborne won't kill you but we aren't saying anything else.
That said, individuals at the FDA have their own opinions about drug pricing, and if they think something is just a copycat of another drug with a 100x mark up, that can have an influence on the approval process, largely through making more demands on the approval seeker.
That could be a problem. Probably the right way to put this is that the procedures should be designed on cost-benefit grounds. Whether a full cost benefit analysis of each decision would be cost effective or not is uncertain.
NICE is a great example to look at. The QALY based approach is much better than how it's done in the US. (Note, the "death panel" rhetoric seemed to be effective when this sort of thing was last contemplated during the ACA negotiations).
I have a sneaking suspicion that if you allowed insurance companies to deny treatments that are FDA approved, what would stop them from just denying ~all treatments? Maybe the argument would be "in a free market who would buy that insurance", but I think the "FDA approved treatments must be covered by insurance" rule might currently be keystone of the existing regulatory structure and so couldn't be removed without other changes.
I think you'd need to switch to something like single payer to be able to decouple the FDA from insurance approvals. Sketching out a way for this to happen:
1) Medicare for all
2) Medicare is allowed to negotiate drug prices
3) Medicare uses a QALY-based system to decide which treatments it will approve
I'd like to use an insurance company that says "we will approve anything that costs no more than $X per QALY."
It would take a while to figure out how to actually run the formula: you can add more variables to the function to change the output, but using NICE as a model would work for a first pass.
Imagine that your dentist is telling you that in a short but unknown number of years, you will have to go through _large number here_ units of pain and suffering if you don't get them extracted now.
What would you like the insurance company to do? If your response is that the patient or dentist could appeal, then you've reinvented the American healthcare system, complete with prior authorizations.
I think your post points out that they do cost/benefit - but they are weighing the wrong cost (how likely am *I* to be blamed if something went wrong) much too highly.
My read here is that the FDA is structurally hard-wired for making decisions in a regime where the cost/benefit margin is very narrow, for example where there are already drugs treating the condition and you're just trying to show that you're better than the current best option. In these cases having a long and rigorous process where "default to no action" seems at least defensible. "First do no harm" etc.
So perhaps you could say there's an informal cost/benefit, but I'd argue that it's at best accidental -- and I'm not even sure that this is the right way of framing it, because I really do think that regulators are explicitly opposed to the cost/benefit lens. Certainly, many public health figures recoil in horror when you suggest that this logic should be applied to the problem. Remember when the German regulators said "we know that the risks of Covid are higher than the risks of blood clots, but we must pause the vaccinations because the rules say that all side-effects must be listed on the drug". I think the FDA considers things similarly.
My impression is that the Thalidomide crisis is pretty deeply carved into the FDA's organizational DNA; they still have this historical memory of the time that the EU regulators approved Thalidomide, and the FDA heroically applied skepticism and correctly averted a crisis.
I think a more explicit cost/benefit framework is the solution for the "too strict/not strict enough" mis-calibration you observe. It seems uncontroversial (or at least inconsequential) for the FDA to err on the side of being conservative on approvals for mostly cosmetic treatments (e.g. breast implants) or cases where we already have treatments (e.g. the next anti-depressant), but there's clearly a highly broken process when you look at the cases where inaction actually costs lives; for example, the fact that at the time of the AZ blood clot panic the US was sitting on something like 50m AZ shots that were not approved, despite them obviously working if you looked at the UK data. Deploying these vaccines could plausibly have saved thousands of lives, if we'd got to vaccine saturation 3 months earlier. Similarly, the pause on J&J (though I'm not certain if that was led by FDA concerns).
Having said all this -- based on the current discourse, I don't think the public would be on board with a cost/benefit analysis approach.
My point with Thalidomide is just that it gives us a possible explanation for why the FDA might be overly conservative. It's both a lens to understand their existing organizational psychology, and also to test/craft the messaging on any possible solution.
For example, with a cost/benefit approach, if you re-analyze the Thalidomide approval process with a proposed new framework and get the result "this drug is for morning sickness, the absolute benefit is quite small, so we should be extremely conservative", then I think you could persuade FDA people that you're not just opening the floodgates on a wild-west of drug approvals. And (I suspect) if you use Thalidomide as a case study that works well, you might win over more of the establishment.
On the other hand if the new proposal is just "approve any drug that has been approved in the EU", while I personally think that would actually work out as a net positive, it's probably not going to be a popular position with the FDA as it fails the Thalidomide test. Or similarly if you just propose blanket loosening of standards.
I would think that in a cost benefit approach information from trials run in other countries would have some weight in the outcome. So totally excluding information from those trials would be inconsistent with cost benefit analysis. On the other hand, cost benefit analysis is both more and less than "approve anything approved by certain previously vetted foreign regulatory agencies."
Thalidomide is a great example of the bankruptcy of the FDA's legitimating arguments. It was rejected in the U.S. based on the old safety standard--does it have dangerous side effects?--but that wax used to leverage a completely different efficacy-testing standard that has essentially no bearing on why Thalidomide was blocked in the U.S. (Added irony that of course it is now a useful drug in number of areas.)
The rule suggested by Thalidomide is "automatically approve any drug approved in the EU but only do so *after* a short bureaucratic delay - say 2-5 years - to allow us to notice if the new drug produced any blatantly obvious negative effects on the Europeans who started taking it first."
Re. "In these cases having a long and rigorous process where "default to no action" seems at least defensible. "First do no harm" etc." -- "First do no harm" fails the trolley problem. That's not reasoning; it's just invoking virtue ethics, which IMHO are unethical.
We should at least have a cost/benefit analysis in terms of quality-of-life and of lives saved, and the FDA doesn't do that. It never asks, "Will approving this drug save more lives than it costs?", let alone the same question for quality-of-life.
They give lip service to cost/benefit analysis. But they clearly use those terms in a sort of subjective gestalt-y way, rather than any attempt to be truly quantitative by, for example, attempting to calculate estimated "net years of life lost" from approving or delaying a drug.
By the way (apologies if you've covered it already). But an ideal A-B test demonstrating the FDA's corruption/incompetence would be to compare it's fast track approval of Remdesivir (expensive, patented and ineffective) with its active discouragement of Ivermectin (practically free, already approved as safe, and lots of data showing efficacy).
Or alternately: they do use cost/benefit analysis but not with lives lost. If their CBA is entirely in terms of public perception instead of public health, I imagine you'd get a system that looks a lot like the current one.
Which suggests that getting enough people angry enough with the FDA is the only way to improve it. Probably hard to get the majority of Americans to Scott's level of frustration though!
A cost benefit analysis implies the price of a drug is known but it isn't. Drug prices change usually going up over time but then going down once they go generic. (Although you can sometimes get rapid price increases in generic drugs, for example if the market is small and there's only one company that goes through the trouble of setting up manufacturing for the drug).
I think an issue missed here is what do you do with a drug whose benefit is difficult to see in the timescale of a reasonable study? A drug that stops or reverses Alzheimers would be ideal and would have no trouble sailing through a study. The reality is we know Alzheimers is a very difficult disease and most likely the best drug we are likely to get before we get to science fiction level technology (i.e. rebuilding brains with nanobots) is one that goes to work early in the process lowering symptoms or delaying the onset of the disease years, even more than a decade later.
The surrogate marker appears to be the only way to get at drugs that fit in that category if we don't want to wait 10-20 years to learn if a drug will work. Perhaps some of the angst here is that all the benefit of the drug derives to the company today and if 20 years in the future we learn the drug did absolutely nothing, well everyone's moved on.
Drug companies are attempting to cover the costs of approving the drugs that get through the process, as well as the failed attempts. They have to cover it during the period where the successful drugs are covered by patent, because afterwards they are competing solely on price with other companies that didn't pay for that approval. It's not surprising that the price is variable and high, then falls sharply once the patent expires.
Yes you probably know this but I felt it necessary to explain it again.
Yes, however economics says the price should be 'what the market will bear'. Think of a movie studio that has had a lot of big budget flops. When they get a hit, you don't go to the movies and discover that movie costs ten times as much "because we have to cover all the money we lost on the previous 75 Suicide Squad movies we made". It is what it is and hopefully a studio doesn't get too many duds.
This question though gets very tricky when there's no obvious market mechanism in place. With movies it's very simple. Either peopel are willing to pay ten times the ticket price or they aren't. If they are, the studio will recoup their lossses, if not the studio will eat them and hope their future movies will be more hits than Suicide Squads.
"What the market will bear" becomes very fuzzy when you have both patents (government interference in who can make the good) and insurance markets (government interference in both who can purchase the goods and at what price, as well as the ostensible customer not knowing what the price is, let alone paying it).
Movie making has its own interference such as subsidies to make movies in certain places with certain classes of people or companies, but drug making has much more. I don't think "what the market will bear" is a useful heuristic.
Well ultimately we as a society are willing to say we don't care when it comes to movies. If DC studios can't make a great Justice League followup because they had so many bombs investors pull the plug on them, we as a society will shrug. If you can't afford the movies because you spent all your money on vaping stuff, we shrug.
Not a call we are willing to make with life saving drugs unless we are willing to mandate insurance ala Obamacare.
You don't need to know the cost of a drug for the FDA to do a cost benefit analysis. The cost is side effect/death vs lives saved/improved. The cost of the drug is mostly irrelevent.
Agreed, but perhaps to flesh this out more, I think there's two cost/benefit calcs to be done.
If approval and insurance coverage were decoupled as Scott suggests, there's a cost/benefit on whether you should approve a drug at all (is it safe). Then there's another cost/benefit on whether your insurance should cover it (is it cost-effective).
When you go down this road you quickly get to "how many dollars can we afford to spend to save 1 life", QALYs, and then people in the US start shouting about death panels. But with limited resources at some point you do need to do cost/benefit to decide how to prioritize who gets the treatment that they need and who doesn't.
For sure, the devil is in the details. But I think some variation on Scott's 5-Star system is the most straight forward. There are way too many shades of grey and evidence is shifting over time (and tons of arguments on whether or not study X was properly powered, biased, p-hacked, etc). Plus we are barely even scratching the surface on understanding how drugs work with different genetic populations.
The FDA can say "this drug improves outcomes for people in profile 1 by 2.3 years, and people in profile 2 by 8.2 months. It raises the risk of heart attacks by 30%." And on and on. Be the clearinghouse for that, the one-stop-shop that people go to.
Deciding "is this worth paying for?" needs to be someone else's job. Maybe the numbers come out to be $100/QALY or $billion/QALY. (Maybe, *maybe*, the FDA could even come up with that number, too, but that's as far as they should go.)
I feel this is already done by the FDA. The FDA will accept a drug with dangerous side effects if it is offset by serious potential benefits for patients with very dangerous diseases. For example, consider most chemotherapies are pretty harmful drugs but are used in cancer because the alternative is uncontrolled spread and death. If someone invented a drug that treated restless leg syndrome but had the same risk profile, I suspect it would be a hard sell to the FDA.
that's not evidence they do cost/benefit analysis though. That's evidence that they have approved drugs with severe side-effects in some circumstances.
"FDA physicians and scientists then review the drug research and the labeling information on how to use the drug. If the findings show the drug’s benefits outweigh its known risks — and that the drug can be manufactured in a way that ensures a quality product — the drug is approved and can be marketed in the U.S. The FDA will continue to monitor the drug post-approval."
They may say that, but it sure seems like first they inflate the risks by several magnitudes, and only then weigh them against the benefits. Relatively miniscule risks prevent them or delay them from approving tons of drugs with proven benefits that far outweigh those risks.
They should at least use cost-benefit analysis in determining the standards they're going to use in their approval process. And those standards are much, much too risk-averse.
Better said, of some risks but not others. There is a probability distribution of both benefits and costs. There is a risk of not approving a highly beneficial drug and a risk of approving a drug with horrendous side effects.
True. "Risk-averse" is a pretty meaningless term when you think about it. Though I think it's commonly understood that the phrase refers to "risk of something bad *happening*" and not "risk of something good *not happening*".
"FDA physicians and scientists then review the drug research and the labeling information on how to use the drug. If the findings show the drug’s benefits outweigh its known risks — and that the drug can be manufactured in a way that ensures a quality product — the drug is approved and can be marketed in the U.S. The FDA will continue to monitor the drug post-approval."
The FDA does formally use cost benefit in terms of comparing the drugs benefits to drawbacks. It does NOT do a cost benefit analysis in terms of monetary terms. If you had a drug with a very minor benefit, like a mild sleep aid, but a side effect profile that looks more like strong chemotherapy, it would have a tough time getting approved.
The other thing we need to unbundle, is drug *endorsement*, unbundling "effectiveness" from "safety". Somebody needs to be in the business of looking at the evidence and saying "yes, this drug actually is an effective treatment", because having all the doctors read all the articles in all the medical journals is not a realistic option. And Derek Lowe is too busy and we all want you to occasionally write about things other than pharmacology.
There's no harm in the FDA approving a drug about which the best that can be said is "mostly harmless", if that's all they are doing. That gives us a long list of mostly-harmless, mostly-useless drugs. And if you're going to have a government bureaucracy telling people what they can and can't do, "you can't inject dangerous stuff into other peoples' veins" is probably a good place to draw that line. If someone else is compiling and evaluating the data on efficacy and sorting everything into "wonder drug", "OK treatment", "might help if nothing else does", and "placebo" categories in a readily accessible way, then we get the outcome we want. But if nobody else is doing that, then doctors and patients and insurance companies are all going to look to FDA approval for that.
And that either gets us lots of prescriptions for mostly-harmless, mostly-useless, $50,000 snake oil, or it gets us prohibitions on putting fish oil in IV nutrient for infants.
These are slightly unbundled, in that doctors can prescribe drugs off-label, if FDA has approved them for some other disease. Before 1962, they were much more unbundled. FDA's focus was safety and purity and drug innovation was more robust, as Charles Hooper and David Henderson showed last year. https://twitter.com/regardthefrost/status/1322681972628443137?s=20
Someone had a good rebuttal to this in a previous comments section to the effect of "look at the side effects of cisplatin and tell me that drug is 'safe'". Most drugs are unsafe, to the extent that you would not want to eat them for no reason. Risk/benefit is the only way to look at drugs.
What that rebuttal tells me is that the safety rating should not be a boolean. Ok, what about a 5-star side effect rating, which we can then compare with the drug's effectiveness rating, and perhaps the severity of the condition? You can still prescribe based on risk/benefit, but measuring and certifying risk and benefit separately looks like a huge improvement over what we currently have.
It looks to me that the bigger problem is lack of urgency. The FDA doesn't factor in that taking time to decide something kills people. Unbundling risk and benefit means now you have two offices you have to wait for.
I have had this exact conversation with my Congressional representative -- that as long as "this drug is safe enough to sometimes try to use" and "this drug is so effective it is a crime for health insurance not to cover it" are conflated, the health care system will both waste tons of money and needlessly delay drugs.
I'm not at all confident anyone will do anything about it. The Democratic majority in the house appears less interested in legislating and more interested in organizing protests. And the Republicans are even less interested in fixing anything with the American health care system.
I think the lawsuit happy legal environment in the US should get a lot of blame for this also. There are many useless and wasteful things that I have to do in medicine mostly because of the fear of getting sued. I believe many guidelines are developed with this as a background threat also and tend to trigger too many follow-up tests and exams.
Do you think there's something to learn from the EU? IIRC Tabarrok has been banging the drum for reciprocity in regulatory approval for years. Not that any of this matters unless and until Congress becomes capable of writing and passing legislation again.
I agree with Tabarrok on basically everything. I haven't read all his stuff, but I didn't think he thought the EU was necessarily better than us - I thought he just felt like we should have reciprocity with them to give two chances for approval instead of just one. I agree with this.
Also, it means that a pharma company only has to pay a billion dollars to get a drug on the market, rather than a billion on FDA approval and another billion on EMA approval (IIRC, it actually works out more like 800m on trials and 200m on FDA bureaucracy and 200m on EMA bureaucracy, so 1.2bn, but still).
What benefit does it gather for a different bunch of bureaucrats to assess the same evidence to essentially the same standards.
It is so stupid that we have to run trials in the US for US approval and in Europe for European approval. If the rest of the world was like that there just wouldn’t be any medication for 80% of the worlds population. That’s also how you get into the situation that we still can’t have access to the AZ vaccine here
Yeah Japan is usually also that way but I have seen them ok something before where it wasn’t really a Japanese trial and you can also get away with a global trial with just 1 site in Japan. Usually we ignore everything besides us, eu, and Japan
This reads as if it is informed by conversations with CDC personnel and not with conversations with FDA personnel, or just based on a bunch of third-hand reporting. FWIW, the real issue here was Trump/Bannon's dismantling of the Global Health Security and Biodefense unit in the National Security Council, which was responsible for pandemic preparedness. In my opinion, you needed someone at that level to bang heads together as between CDC and FDA, and to get the President to make a decision. The rest of the piece is interesting, occasionally useful, but quite misinformed.
That's really not helpful, either for the discussion generally or for making your argument look sound. You are acting like you have a hammer, and so everything must be a nail.
Thanks--that's a totally fair comment, and very helpful. I'll respond now to the bits that set me off, and I may respond more fully later to the inferrable content in the one sentence I found meaningful.
trebuchet's way off-base "restatement" of what I was saying _is_ lousy criticism. It's not even in the same ballpark. It's entirely fair for me to refer to that and ask for better criticism than that. If you don't see the difference between what Trebuchet said and what I said, let me know, and I'll try to clarify.
And then there's the "orange man" reference. That is entirely irrelevant to the argument I was making. It's the kind of statement I've seen before from those on the right who erroneously suggest that I'm making ad hominem arguments when I am not.
So that leaves one sentence, which assumes its erroneous conclusion. FDA didn't feel "compelled to prevent highly qualified doctors and scientists from testing for a deadly virus"-that was the outcome of what could be described as a turf wat between FDA and CDC. There are, arguably, any number of things that are wrong with the FDA. Most of them are "fundamentally" caused not by FDA, but rather by a dysfunctional Congress since about 1994.
So I hope that helps you see why I'm asking for better criticism. with the exception of the "deeply and fundamentally wrong" point, the rest seems to me to be pretty easily recognizable.
I can see why you don't feel like his summary accurately represents your view, but I can also see why he thinks it does. And since I lean more to his view, I'll elaborate a bit.
Basically, the FDA and CDC are medical agencies who work in this space - the CDC ought to *be* the pandemic preparedness agency, not need an external one, and the FDA ought to have programs in place for expedited approval in emergency situations. Some small(at least, by comparison) coordinating office ought not to be required for them to have done those things. If the lack of a National Security Council unit was the deciding factor here, the CDC/FDA pair were incompetent to begin with. And likely, incompetent to the point where the NSC couldn't realistically help the situation much.
Re "orange man", you specifically named Trump and Bannon in your first comment, and said that their action was "the real issue here". That makes it seem like issues with Trump were a big part of your concern. And, per my last paragraph, I have difficulty seeing how this decision had any effect on the things we're taking the FDA to task for. It could plausibly have saved a day or two in January by monitoring the world situation, but that doesn't seem to have much to do with which test kits get approved or banned.
Re the turf war thing, wasn't the whole issue that the FDA trusted the CDC so blindly that they banned everyone else? That sounds like the exact opposite of a turf war to me.
Re the dysfunctional Congress, that'd be a better explanation if these issues were only post-1994. I wasn't paying much attention to politics before that, but my understanding is that these issues predate that by decades.
Thanks! There are too many "oughts" and "seem like" and "likely" "makes it seem" for me to really want to respond here. Those all represent your assumptions about the way the world _should_ be. Your "oughts" weren't the facts on the ground at the time, or even now, so the points you make based on those assumptions are hypothetical, to me. Same point with your likely--it's pretty much assuming your conclusion. Issues with Trump qua Trump? I don't care. Issues about Trump making many appointments to HHS (writ large, not just the mothership) that I thought were pretty bad? I care about that a lot.
How did Trump's decisions affect anything outside the two-ish paragraphs about COVID testing? In fact, how did Trump's dismissal of a different branch of government cause the FDA to ban COVID testing?
I agree that many bad things happened to screw up a potential US test-and-trace program, and Trump's decisions were among them. But I also think that we could have recovered (maybe not completely, but at least partly) from our government's bad decisions if labs/universities/hospitals etc had been allowed to take up some of the slack, and that the FDA's ban on that was genuinely really bad.
I think "Trump knocked the US response down" and "...and then the FDA prevented it from getting up" are perfectly compatible.
As for the rest of the piece being misinformed, if you're going to accuse me of that I've got to insist that you be more specific.
FDA didn't ban COVID testing; it restricted it to CDC's tests, which were problematic, to say the least. FDA "prevented it from getting back up" because of miscommunication and miscoordination between FDA and CDC-FDA thought CDC had a functioning test. That miscommunication and miscoordination would have been resolved by a functioning Global Health Security and Biodefense unit in the NSC-think of this aspect of it as the semi-circular canals of pandemic response: "Hey, our center of gravity is way misaligned here-better straighten up, or we're going to fall over."
You have a good point about "misinformed" regarding the rest of the piece; I apologize for me poor wording-my judgment was influenced by your writing about the testing. A better choice would have been "unrealistic", as I think you largely acknowledged. The outcomes you're calling for might be improvement (ignoring significant potential unintended consequences), but unless you're willing to even sketch out a realistic path to achieve them, I think "unrealistic" is a fair description.
No, the FDA stopped private labs from offering in lab covid tests, and dragged its feet on approval. To be absolutely clear, the FDA act doesn't govern lab-developed tests the same way in ordinary times. They acted in a way that made the problem worse, illegally.
The FDA did not have to exceed what the black letter law says about regulating labs only to get slapped down in courts months late. The FDA did not need to mandate labs validate tests with samples they couldn't get. Even given CDC had a working test, there is no harm in letting Quest run its own tests as well.
Responsibility for the FDA's actions lies in the people who took them. The idea that the FDA needs adult supervision to do its job only underscores the need to sack everyone in that building. Responsibility for not correcting those actions lies with the HHS secretary and ultimately the President.
It's not about "adult supervision"; it's about turf wars between different agencies, and you need someone with authority to settle those disputes. "sack everyone in the building"-you do know that 18,000+ people work for FDA across the US and overseas, right? You're right about responsibility being with the HHS Secretary (who normally doesn't coordinate these kinds of disputes) and ultimately the President, but you're at least partly wrong about the nature of the problem.
The FDA did that for the same reason that they do most things - they're professional paranoids, and live in a dream world where everything they touch is secretly thalidomide in a trenchcoat.
"FDA didn't ban COVID testing; it restricted it to CDC's tests." This is a non-sensical statement that does not address Scott's point, or any of the reporting on this subject. No one thinks that the FDA issued a statement saying, "NO ONE IN THE UNITED STATES SHALL TEST FOR COVID!" That would be absurd. We know they're not mustache-twirling villains. What people think happened, and what this article alleges, is that the FDA only allowed a type of testing which didn't really exist, which you admit when you say "The FDA restricted testing to the CDC's tests." Everyone outside of the FDA was aware that there was no viable testing apparatus being provided by the CDC, so why was the FDA forced to pretend there was one until and unless Trump stepped in?
My understanding is that it's not a black-letter law they have to follow. Instead, it's precedent - if it's FDA approved, and someone kvetches at them for not covering it, the kvetcher usually wins the ensuing lawsuit. Or at least the PR battle.
This does, of course, make it somewhat harder to fix.
HMOs were extremely effective at keeping costs down by saying "no, that's not worth it." They gradually lost the ability to say "no" by lawsuit after lawsuit.
The history of radical chemotherapy should be instructive here.
The coronavirus pandemic revealed a “clash of cultures” between the White House pressing for faster progress on vaccines and treatments and the Food and Drug Administration’s efforts to stick to the science, outgoing Commissioner Stephen Hahn told POLITICO.
“I heard loud and clear from the White House — President Trump and others — that they wanted FDA to move faster,” Hahn said in an interview Tuesday, less than 24 hours before President-elect Joe Biden is scheduled to take office.
...
“With time, particularly over mid- to last summer and then into fall, there was a substantial amount of pressure,” said Hahn, who took the helm at FDA a little over a year ago.
</quote>
The Trump administration pressured the FDA to move faster on vaccines throughout the epidemic. This caused the entire US media to align itself with the FDA, and literally every article I've seen on the topic presented the FDA's foot-dragging as standing up for science and rigor in the face of Trump's lunacy. If not for that, this new Atlantic piece would likely never have been published.
Scott cited the investigative journalism done by the NYT so you know what informed his writing. What part of their characterization of COVID testing mismanagement do you think are misinformed?
The FDA acted like most government agencies at any level - not with malice or hatred but bumbling ambivalence. The solution to that isn’t adding more bureaucrats to “bang heads together”. The solution involves evaluating and changing the incentives of the stakeholders.
That's a misinterpretation of the one article I looked at. How about you provide a specific link to the specific article and quote the text you think establishes this?
You made the claim that his post was informed by “a bunch of third-hand reporting”. So “how about” you read more than one of the articles linked if you’re going to imply the source material was too biased for the post to have any use?
Then you’ll find the article about Helen Chu’s kafkaesque tale of fighting with CDC/FDA/IDGAF bureaucrats to do the right/best/sane thing.
Can you explain in detail what happened, and what people and processes and organizations really caused this? You sound like you know a lot, and are understandably upset at people assuming things, and I’d really like to learn more of what you know here + links to good and long articles to read if you know any.
That unit was one person that does nothing but chairs meetings of the interagency that go on anyway and then writes a summary of conclusions that people yell about and occasionally makes a read book for their boss if they care. Its not some far reaching unit of people who actually do things, its normally like one person from the CDC or DHS or State on rotation for a year who just does their job in a cube at EEOB instead of their agency HQ. Do you have any idea how the NSC actually works?
I do, at least a bit. That "unit" was a directorate, with permanent staff, prior to the dismantling under Trump/Bolton. Just to be clear, I'm talking about the National Security Council Directorate for Global Health Security and Biodefense, which was headed by Rear Adm. Timothy Ziemer, who reported to the NSA. What are you talking about?
Was his reporting to the NSA on the offensive or defensive side of cyber warfare, or on some other part of the NSA's portfolio? What does "Global Health Security" have to do with US-internal review and approval of diagnostic tests, given that the rest of the world had plenty of perfectly functional tests for the same disease? How much actual authority do you think that "Directorate" had in less than two years of existence?
You are stretching really, really hard to find some way to blame the CDC and FDA screwups on COVID-19 diagnostics on Trump's White House, and you have yet to show any defensible link between the two.
The three people in the NSC, two of which were simply moved to the counterproliferation and biodefense directorate in the NSC, still working on pandemic response after the re-org, had approximately zero effect on pandemic preparedness. They didn't direct the CDC or the FDA or anything, they wrote and discussed reports about pandemic preparedness to help keep the NSC keep informed.
Yeah, I've read that WP article, and many others. What you're saying is entirely accurate and entirely irrelevant; I was responding to what Mike I said about the Directorate. And you don't address the elimination of the Director position. I mean, they don't put Rear Admirals in positions just because they like the pretty shoulder boards (well, usually.....)
To be more explicit: it would have been Ziemer's role to sound the alarm to the NSA who should have passed it along to the President ("Hey! We don't have tests! Here's why and what we should do about it!"), and to convene a Cabinet-level meeting, etc. So this isn't about "pandemic preparedness", this is about the stature of the Directorate and its ability to get Cabinet-level and Presidential action.
Why would they be better at that than the CDC/FDA heads? There's literally over 200 people of Rear Admiral rank or higher in the USN(https://officerassignments.com/vice-admiral-vs-rear-admiral/#:~:text=In%202015%2C%20the%20United%20States,35%20Vice%20Admirals), and probably close to a thousand of equivalent rank in the whole military. It's not like any President was likely to know the guy by name. Ziemer > O'Brien > Trump isn't any faster than Hahn > Azar > Trump. (That path would be faster on a scale of minutes, but covid isn't an ICBM, and doesn't operate on that time scale.)
that department still exists - trying to blame crappy COVID response on minor org reshuffling is misleading at best. And claiming that a government bureaucracy that has never faced a true test would have made all the difference is rather far fetched.
"People are really scared of this solution, because it introduces choice into this system. If you say that insurance companies are allowed to cover a certain drug, but not forced to do so, then different insurances will cover different drugs, and you’ll have the usual capitalism / free market thing."
Unfortunately, you will not. There was a SSC article (or many) covering exactly this. Most health insurance is through employers, and there is often no real choice at all (choose between Plan A or Plan B with minimal differences). Even when there is real choice, it's rarely of the meaningful I'll-take-a-no-aducanumab-plan-for-$100-less-a-month variety - instead, usually it's high-deductible vs low for the same services. And even when there's real choice, it is borderline impossible for anyone to learn enough about the differences to make an informed choice, let alone a rational one comparing risk-adjusted costs and benefits.
Theoretically, sure. But in practice, captitalism/free market choice effects is not how (private, US) health insurance works. SSC has covered this quandary perhaps better than anyone else, so it's odd that this paragraph would be included with a disclaimer or footnote or something.
Yes, but I don’t think it would make a difference. If you’re a company benefits administrator, would you rather deal with one insurance company or 10? Would you get a better price if you had 100% of your employees on one plan or 10% on each of 10 plans? And aside from the few candidates that have a specific rare health problem and need a specific thing to be covered, I don’t think you’d see any real recruiting benefit from offering more choice.
Employees looking for a job ask "Who is your insurance carrier?" and almost never ask "and can you give me the Summary of Benefits and Charges?" I've never known a single employee to ask about the actual list of benefits and charges, which is hundreds of pages long and covers thousands of treatments that you and I have never heard of and will never need. Even if they asked and read them in detail, it would be impossible for anyone to make a truly informed decision about which plan really fits them best. They'll maybe have some family history and take the plan that covers cancers better or something, but that's rare and still unpredictable. Maybe they got the wrong kind of cancer, or got heart disease, or maybe never have a major medical issue. People tend to work at the same company for periods of time in which their health care needs change.
Benefits managers are highly incentivized on costs, and get mostly noise and gibberish otherwise.
In my professional life, I've had no problem getting a detailed list of benefit from HR. "My wife needs to see it," I say, and it gets coughed up pretty fast, because it's not like it's a secret or anything.
(And my wife *does* read it and says "this is good" or "this is crap.")
But we have Bronze / Silver / Gold that got established through Obamacare, and those mean something, right?
Those things certainly exist, and I don't doubt that some people have looked at them in detail. As I mentioned, some people know of family history that would make certain types of testing and treatment more important for them. From the perspective of a benefits manager, trying to determine which plan to use, there just aren't enough people doing that to move a company towards or away from plans based on the specifics of coverage. Maybe at a very small company, a voice or two could probably reach the manager and shift attention.
Bronze/Silver/Gold are actuarial differences, and don't really tell you whether "Procedure X" is covered or not. Obamacare actually got rid of a lot of the variations in what is covered, so that plans are far more standardized now than before.
I don't think so. It's been a while now, but I don't remember this changing materially before and after the ACA. The only things I really noticed were the lifetime limit disappearing and checkups becoming free. The amount of choice either within a provider or between the two providers my work offered didn't change in other ways that I found noticeable.
Is the concept of “choice” coherent in health insurance? How can one choose a plan that may or may not cover a future illness that may or may not be treated by an as-yet-unapproved drug? The attempt to impose free market concepts to healthcare is fraught from first principles - everything isn’t a widget.
That's true. I want to say that employers exercising choice is better than nothing, but I guess the "employers will only select good insurances because they want to attract workers to work there" incentive chain is so tenuous as to be almost nonexistent.
But is that a circular problem? It seems tenuous today because insurance companies are undifferentiated in what they cover, because the law mandates it be so. If it didn't then insurance companies might start trying to build brands on only covering the right things, and that would feed through to employer policies. It might also incentivize the unbundling of health insurance from employment, which is not inherent to the insurance/regulation model but just a historical quirk of the US market.
But the problem is if some cute kid or sympatric adult is dying of some disease their insurance won't cover the public will insist it be covered. We sure as hell won't say, "Well, you decided to save $100/month buying the insurance that clearly stated on page 543 of the contract that they don't cover that specific treatment for that rare cancer so too bad."
It's a problem for sure. Health insurances can cover a lot of things that aren't exotic cancers though. In Switzerland a lot of policies famously cover massages. Note: not expert medical massages for people with exotic muscle problems. Massages in general, for anyone. That sort of "lifestyle health care" is where they can differentiate.
Isn't massage coverage pretty common? Here in Canada a typical employee benefits package might be dental, life/AD+D insurance, prescription drugs, and 'extended health' (massage, physio, counseling, chiropractic, etc.) and providers compete on the specifics of coverage limits, which brand-name drugs to cover vs. generics, co-pay percentages, that sort of thing.
... and federal civil servants complain about their conspicuous lack of massage coverage compared to every private employer anywhere. Their package is pretty good otherwise though.
The incentives between insurance companies and employers offering insurance is to be very streamlined to what people tend to want over the timeframe the employer considers relevant. That means weird treatments that cost a lot of money and help few to no people are out. Standard fare regimen treatments for conditions like diabetes and high blood pressure are covered well. Rare items might be covered as well, if they are common enough and treatment is predictable enough to cost it out (think breast cancer or open heart surgery, but not weird diseases nobody has ever heard about).
Disagree. Those ones are cheap to cover, because they're so rare, and people raise a stink when they get Unheardof's Syndrome and find out it's not covered. It's just that a lot of those niche diseases have extremely expensive treatments, because there's so few patients to amortize development/approval costs over, and those extreme costs per patient are what drive insurers away.
Rare diseases are an easy cut for insurance companies, because hardly anyone ever complains BEFORE they have the disease, and if they complain after the company has saved millions of dollars in claims by not covering it. That is, if they're allowed to cut them piecemeal. Sure, 200 people across the country may get screwed when they contract the disease, but most people will go on never having heard of it and not complaining about it.
The problem with this is that the "if it didn't" was recent, and we didn't see that kind of thing. At least, not to my recollection. Other over 40s, anyone remember this differently?
I mean, to be fair, "we need X" and "the ideal is Y (which depends on X)" aren't really contradictory. X in this case is "abolishing employer-based health insurance".
I used to sell group health insurance. There's definitely some differences in which insurers and which plans cover what. And if a wider variety of coverage levels were legal, you'd likely see more choice.
It'd be trivial for insurance companies to offer policies that cover the 2*, 3*, 4*, or 5* formularies, and also fairly easy to explain. And even that very simple level of choice would help a lot with cost control. If you want more choice than that, you'd probably have some intermediate formularies that get assembled by some big prominent medical association to split some of the differences.
The police also face incentives to be lax when they should be strict and vice-versa. A crazy guy might fight back - better stay away and not get hurt. And someone making money might have stuff worth seizing through civil asset forfeiture.
And if the crazy guy *does* answer the door and *does* attack them and they *do* shoot him, every piece of news media from here to Mars will have articles on how they should just have talked him down, or let a social worker handle it or something, instead of murdering in cold blood a poor sick man who had done nothing wrong. I can see why they'd decide "well, we tried knocking, nobody home, let's not kick the hornet's nest" and then leave.
This is somewhat off-topic but Scott's regard about the police seeming omnicompetent compared to the FDA made me think of my own changing views on them. During the GWB administration I would have told anyone that the police are simply the largest organized criminal gang in any city, who commit crimes all the time with impunity. Importantly, crime had been going down for most of my lifetime. Since 2014 and 2020 I have learned what happens when the dominant gang steps back and lots of little gangs are unrestricted enough to shoot each other up and probably not get caught.
I think the most direct and simple, if incomplete, example of this is to compare how many police kill with how many they arrest. There's a lot of rhetoric about how police go around killing whoever they want whenever they want, but they arrest around 10,000,000 people a year, and only 1000 end up dead. Given that their job is literally to forcibly control people, I think this is not that dangerous a ratio.
And somewhere over 900 of them turn out to have been armed.
That said, it's still a pretty bad ratio compared to police elsewhere. Per capita, US police kill at least an order of magnitude more than most other developed countries. Some of that can be chalked up to the American public (much more likely to be armed, and often less fond of compliance with authority in general), but not all. There's some real issues in American policing practice.
>And somewhere over 900 of them turn out to have been armed.
In America you have a near absolute right to be armed. That doesn't excuse the cops shooting you.
The police in America have a conception of themselves as being uniquely endangered (they aren't in the top 10) and as therefore being uniquely justified in doing whatever is necessary to come home ("better to be judged by twelve than carried by six"). This culture leads to a lot of preventable deaths.
I also happen to think that our gun culture does that as well, but I don't think the armed thing should be a qualifying excuse. Especially since most of those guys vote for the political side that brought us lax gun laws over the last generation or so.
Sure, I mention being armed mostly to counter one common narrative. (Though of course, a right to be armed is not a right to threaten or attack people, and many of the armed deceased were doing exactly that. Ma'Khia Bryant is an obvious recent example here.)
There are other developed countries with high rates of gun ownership, but without people actually shooting each other nearly as often. And there are places like Russia where the rate of gun ownership is low (if you can believe the official numbers) but people still shoot each other a lot. The homicide rate is going to be a better predictor of whether the cops themselves are trigger-happy.
Per capita, the US has a lot more criminals that most other developed countries. What matters w/re police killings of innocent(*) people is, what is the probability that someone the police approach with the intent of e.g. issuing a jaywalking citation, will turn out to be a drug dealer or whatnot who thinks the cops are coming to bust him for a felony? The higher that probability, the more rational it is for police to rationally approach jaywalkers with a hair-trigger "but this guy might resist arrest with the vigor and violence of someone trying to escape years in prison" response, and the higher the risk of false positives.
* Mostly meaning "guilty but of petty crimes that nobody would imagine shooting someone over", which is of no moral but some practical significance.
You say that, and then my hand aches again. The police abuse people in a lot more ways then just shooting them dead.
And the real problem is not that occasionally one does so. People go bad sometimes. The real problem but then all the other cops were "looking the other way", or close ranks around them. So, yes, All Cops. Maybe All Cops don't break people's hands in roid rage lulze, but All Cops know those who do, and they "look the other way". All Cops.
This is a pointless appeal to emotion, akin to to sayin you got bad symptoms from the covid-19 vaccine and therefore the vaccines are bad. No one cares about what some random bad cop did to you anymore than you would change your opinion about cops because you heard an officer went above and beyond the call of duty to save someone from being raped.
The obvious and correct response to there being police officers who do bad things is to record video, prosecute, and otherwise get rid of those officers. It is not to abolish the police. There are also plenty of policy changes that are not abolishing the police or chanting ACAB, like eliminating civil forfeiture, that would make the police better even if they wouldn't salve your emotions.
If you read the second paragraph of Mark's comment, you'll see that his primary complain is not that an individual officer was abusive but that instead of "record[ing] video, prosecut[ing], and otherwise get[ting] rid of those officers", "all the other cops were "looking the other way"". I agree that the fix is not "no bad cops ever", that's fantasy land, but when the current system is actively opposed to prosecuting and firing bad actors then they do assume culpability even if they aren't themselves actively bad. Police unions are a huge part of the problem here, from what I've read
Pretty much true, but partial, if I'm understanding you correctly. An equally big issue IMHO these days is the level of political oversight from Capitol Hill, and lack of resources from the Assistant Director level on down.
This is a good, fair, and understated post from Scott. If anything should be hit harder, it is this point about the public choice aspects of the FDA incentives. Amidst a very long description of how things go wrong, there are two paragraphs that identify a primary root cause of FDA dysfunction, those two about social trust as a limited resource being held hostage to the stupidest person. This could use the same level of exploration. It could even keep the parallels with police, who have similar bad incentives that lead to erring on the wrong side as described.
It's a good explanation of where the institutional scarring came from, but fighting the last war isn't an acceptable level of performance.
I thought Scott (or Zvi?) wrote an article specifically on the subject, but I can't find it at the moment. I'm not up to re-generating it myself, but the gist was that in order for the FDA's LESS/MORE lever position to be justified on those grounds, it would need to be demonstrably catching something at least as bad as thalidomide multiple times per decade - not merely denying approval of obviously harmful things, but outperforming comparable approval agencies that let something hazardous through.
No, that's part of the problem. When it was initially founded, the Fed initially caused a very large amount of inflation (WW1 also played a big role). They then decided the stock market was booming too much and decided to pop the bubble, and persistently denied any responsibility for the Great Depression (Bernanke would later say that Friedman was right about the Fed's responsibility, although they differed on a credit vs money contraction being the issue), but FDR devalued the dollar without any of their input and him arbitrarily picking lucky numbers when he felt like it worked better for the problem they were facing (although they still increased reserve requirements to make things worse prior to the depression ending). After WW2 the dominant Neo-Keynesian view among policymakers was that demand needed to be boosted to avoid unemployment and inflation was a relatively minor concern in comparison. Milton Friedman predicted that the relationship between unemployment & inflation would break down, and indeed it did while mainstream economists tried to attribute inflation to factors other than the money supply. Eventually stagflation was an obvious enough problem that Volker/Reagan "broke the back" of inflation and managed to have a decent economy afterward rather than a prolonged slump (the supply-siders played a role there, in an instance where Friedman was wrong). So afterward fighting inflation was the Fed's focus and in 2008 they saw oil prices inching up and decided to contract the economy at the same time it was facing headwinds and again refused to recognize their responsibility. Bernanke's attempt to stop things involved paying interest on excess reserves, a contractionary measure, because he could head off inflation while merely boosting credit enough to save the economy. Now that the Fed is finally coming around to not being terrified of exceeding the 2% inflation target in a single year, you should expect that in an number of decades they'll make the opposite error AGAIN.
Their goals have been the same throughout, as have the underlying laws of economics. Their tactics have ranged from pretty good to pretty bad over that time. However, because they're always dealing with the same issues, they've generally learned from past failures and improved themselves over time. It's not as easy for most other government agencies.
I agree with this, as an instrumental matter the Fed is much more capable than it was in the 1970s. Brad DeLong has beaten the drum for years about the incompetence of Arthur Burns and in particular, how Nixon had him wrapped around his finger. Unfortunately, competent monetary policy is necessary but not sufficient for a healthy economy.
"Eventually stagflation was an obvious enough problem that Volker/Reagan "broke the back" of inflation and managed to have a decent economy afterward rather than a prolonged slump..."
I've been working under the theory that a cost-push stagflation cycle is not possible in the current configuration of the economy because what breaking the back of inflation consisted of was not just the Fed raising the prime rate above 20% but also breaking organized labor. If labor is not capable of demanding higher wages in response to a decline in the purchasing power of a dollar, then how does the feedback cycle close?
Most of the setbacks suffered by organized labor were too late in the process to be likely candidates for causes. Reagan's mass firing of ATCs was August 5, 1981 (and that's often seen as the first real blow against labor, though in fairness I wasn't alive at the time and I'm just getting this from recollections.)
Inflation peaked at 14.8% in March 1980, and was at 10.8% in August 1981. It was below 9% by the end of the year, and below 4% by the end of the next year. (https://www.usinflationcalculator.com/inflation/historical-inflation-rates/) If unions were a major cause, the causal process would likely be contract renegotiations where the unions got worse deals, the annual wage growth slowed down, and then those savings were passed on to consumers. That's too slow to be fixing things that fast - unions were never a majority of the economy, contract negotiations don't happen instantly or constantly, and lower annual raises don't move that quickly either.
The cost-push theory was just wrong. It was all monetary policy. When Venezuela or Zimbabwe print lots of money, it doesn't matter if they repress independent labor unions or not.
If you unbundle allowing doctors to prescribe medicines and mandating insurance coverage, then I see no reason to think a free market will suddenly emerge in the health insurance industry. Changes to FDA procedure would really demand simultaneous changes to health insurance law and tort reform for doctors and probably some other things as well. It sounds like a recipe for a gargantuan bill that will attract special interests for pork and lots of controversy and probably still have negative unintended side effects. In other words, the FDA is totally overdue for reform and I would take 10-to-1 odds it doesn't happen in the next 10 years.
Wait a minute there, Scott. Just because the FDA approves a drug, it doesn't mean private insurance companies legally have to reimburse me for the drug. I'm a Type I diabetic, and every year or so, my insurance company UHC (United Hellish Care) changes up the types of insulins they'll reimburse me for. Since they also have a large retail pharmacy under their wing, [sub]Optum[al]-Rx, I'm sure they're negotiating with the various insulin producers for the best deal. But that means that on short notice I'm given some new insulin which I have to figure out how to recalibrate my regimen around. It's a real pain in the subcutaneous ass tissue.
Or do insurance companies have to cover meds in certain categories, but they're allowed to the select or reject the meds form each category as long as they cover one of them? However, to my mind the effectiveness of meds within those categories seems to be pretty broad. Just sayin...
I am super not a lawyer, but I think what happens is that insurances can declare some drugs to be not on their formulary, but if a doctor makes a case that the patient needs that drug anyway, they have to respond to the case, and if their response isn't good enough, they can get sued for not providing it.
The usual response is "we cover this other much cheaper drug for the same indication, you should just try that one". I expect this is what UHC does with your insulins. There actually are a few other Alzheimers drugs, which somehow haven't made it into this conversation, but those ones also don't really work. I think the main situation where insurances would have to cover this is if a doctor tried the other 3ish Alzheimers drugs, none of them worked (as in fact they will not), and then asked the insurance company to cover this one. I don't think "we don't believe this works, even though the FDA says it does" would go over very well as an excuse.
I'm not a lawyer and this is based entirely on a few articles I've read plus the fights I have gotten into with insurance company representatives.
My experience with insurance companies (employer side) is that you are correct. They make the doctors jump through hoops trying all the generics and cheaper versions. If the doctor is persistent enough, they can eventually call the $50,000 drug "medically necessary" with a paper trail showing all the other drugs failed to work. Insurance companies often refuse to cover the expensive drugs up front, if there are alternatives available.
Forty years ago, insulins were not prescription drugs. I remember purchasing insulin and syringes over the counter. Of course, they were not very sophisticated insulins: Regular, Lente, and NPH. They sold for about $10/bottle. In today's money that would be about $22/bottle. And they were just transitioning from insulins rendered from the pancreatic beta cells slaughtered animals to the new process of making it with genetically modified yeast. And we were told that this would make insulin cheaper for the consumer, plus with the miracle of gene splicing we'd newer types of faster acting and newer extra slow acting insulins. The second prediction came to pass, but the first prediction never came true.
The Pharma companies saw these new insulins as a cash cow. From what I understand, they were probably only making 20 percent margin on the old animal insulins, so I would guess it cost them about $7 or $8 to manufacture a $10 bottle of insulin. The yeast production method made the production much cheaper. I've never seen any figures but considering that after a probably substantial upfront investment in the yeast growing tanks and the refining equipment, these plants can run continuously. I'd be willing to bet that once the costs plants were amortized over a 4 year, it cost big pharma about $2 to manufacture 1cc vial of insulin. But the savings were NOT passed along to consumers.
I don't know whose regulatory arms they twisted but big Pharma made the new insulins Rx-only. And they've been steadily raising the prices over the past 30 years. My fast-acting Humolog costs about $250/1cc vial, and it will provide me enough insulin for about 12 days.The new super long acting insulins sell for $350/1cc vial. Because I use less, one of those vials will last almost a month.
I used to purchase insulins from my local pharmacy, but United Hellish Care evidently stopped reimbursing the small independents enough for them to recoup their costs. Suddenly my friendly neighborhood pharmacist who I had used for 20 years started looking stressed and worried whenever I refilled my Rx's. I didn't know what was going on, until the trainee sales clerk handed my vials with a sticky note on them, and in a tight little scrawl: "Pham, what are we going to do about this?! We're losing money on this Rx!" The scales fell from my eyes. I spoke to the owner, and we had a heart to heart. He admitted that he was running a business and that they were losing money on selling me insulin. I felt bad for him. And outraged at the same time.
Meanwhile UHC was urging me to use their OptumRx mail-order pharmacy. And they were dangling the promise of filling 90-day supplies of insulin (a privilege which they never granted my local pharmacy). So I went with them. The co-pays are the same. But I figure they've got the buying power to negotiate deals with Big Pharma to get their insulins cheaper than my local pharmacy can.
Of course, we blame the insurance companies for this mess. But its not the insurance companies who jacking up the prices of insulin (or any other meds for that matter).
BTW: I checked the prices for insulin in Mexico. I could purchase them over the counter from Mexican pharmacies for about 1.5x what my copay is here (although they don't seem to carry some of the newer types). Likewise insulin is much cheaper in Canada. Canada sets maximum wholesale costs for what Big Pharma can charge. I don't know what Mexico is doing, but somehow Big Pharma hasn't gotten its claws into Mexican health care. So Big Pharma is screwing over US citizens because of the way we've got things set up here.
That's utterly maddening. Running bioreactors is hard, you've got to know what you're doing but it's certainly a hell of a lot more efficient than harvesting pancreases from pigs. More and more, I'm coming around to Matt Stoller's point of view that market power & oligopoly are the dominant reason for the dysfunction in markets. It's the simplest explanation for how pharmaceutical companies are not just capturing all the productivity gains from improved manufacturing but raising prices on top of that.
You have to add US subsiding drug development for the rest of the world into this equation or you aren't getting the whole picture. Its not like pharma companies are extraordinarily profitable (4% net margin IIRC)
They don't make the old animal-based insulins anymore. One can still buy a bioreactor version of Regular insulin over the counter (but almost no pharmacist will not believe you when tell them that's it doesn't require a prescription). I think it retails for ~$150/1cc vial.
What's the justification supposed to be for making insulin prescription-only? Is there some weird recreational use? I understand injecting yourself with a bunch of insulin you don't need is a bad idea, but that's true of all kinds of OTC medications if you take enough of them at once.
Well, back in the late 40's there was fad for losing weight through insulin injections. But that didn't really last long. People really didn't get into the whole injection thing and amphetamine pills became the preferred choice of savvy dieters. ;-)
Also, there may have been some people murdered by perp injecting them with insulin.
I was under the impression that that's also the case for Medicare/Medicaid - that drug approval was a separate thing from them deciding to cover it. I was surprised to read otherwise, since I seem to remember quite a few instances of a healthcare provider family member not being able to offer certain (definitely-FDA-approved) drugs to people on Medicare, since they wouldn't cover it. Nor would private insurers, of course, but typically those patients would just pay out of pocket.
I have experienced non-generic medicine being hit-and-miss with different insurance companies. Some will, some won't. I have some insiders I can ask and will try to follow-up here when I do.
"The answer is: to a first approximation, insurance companies have to cover anything the FDA approves."
I don't think this true. Novo Nordisk just got approval for a drug called Wegovy (semaglutide) for weight loss. The trials were quite impressive. The drug was first approved as a Type II Diabetes treatment and is sold for that indication as Ozempic.
My daughter lost 100 lbs on Ozempic, so I asked my doctor about it. He is wiling to write a prescription for Wegovy, but Medicare has made it clear that they will not cover it under any circumstance. Their policy is not to cover any weight-loss drugs of any type, ever
I will probably go ahead anyway, even though it is ~$1500/mo.
General article: "How a lizard’s venom inspired the promising weight loss drug Wegovy: Semaglutide is the start of a new chapter in obesity treatments." | By Julia Belluz | July 5, 2021
He is a very good doctor, and I really like him, but he is not an endocrinologist. He was not willing to look off label. We discussed it. I respect that and will live with it.
My impression is that most policies are written to specifically exclude "experimental" treatments, and they use non-FDA-approval as a useful (in court) proxy for the definition of "experimental."
Well, they also exclude entire categories of treatment, approved or not, e.g. until the angry feminists got ahold of them, they would routinely exclude any infertility treatment from coverage. It does not surprise me that they exclude weight-loss treatment.
It may, but I think it more likely represents their own internal cost-benefit analysis. On the cost side, if they exclude coverage, then when Sarah the receptionist who weighs 180 in her underwear is refused coverage for whatever treatment she seeks, the rest of the office *may* be horrified, but probably not, and certainly not in the same way they would be if they refused coverage when Sarah's firstborn turned out to need heart surgery to correct a birth defect -- not least of all because at least half the people will probably snort and say Sarah just needs to cut down on the donuts and add some lunchtime walking -- people are generally remarkably and sometimes cruelly unsympathetic to the struggles of the overweight.
And on the benefit side, obesity is one of those things that can have a generally disheartening course, people can struggle with it for years and years, with victories interspersed with setbacks, and the insurance company really doesn't want to be on the hook for something that open-ended.
I think both those reasons are also why they tend to limit coverage of mental health, too. They don't lose much on the PR front by largely not covering it, especially if they throw in 10 appointments/year of counseling, you know, for when your mother and daughter are killed in a car accident and you need to stop drinking or something. And mental health issues are also the kind of thing that can go on for a long time, so they don't like that.
I want to add another point: IMO, Aducanumab isn't shit, it's just that Alzheimer's is really really hard.
Personal background: We spent a couple of lectures in a molecular neuroscience class I took in the spring to review the clinical trials of aducanumab, including the latest trials (EMERGE and something else, iirc), so I dove quite deeply into them.
Aducanumab is not only excellent at doing its direct job - removing amyloid plaques - but also pretty good at reducing secondary biomarkers like amyloid PET signals and ARIAs (small hemorrhages and edemas that show up in an MRI). The problem is with the final proof of slowing cognitive decline, where most cognitive tests in the different trials failed to show statistically significant difference from placebo.
It is also worth noting that amab has an *excellent* safety profile with a wide therapeutic window and few side effects even given the age of the target population.
So what's going on? You can say that amab IS actually completely useless in slowing cognitive decline, but then you need to explain why the different biomarkers, all with well-established connections to neurodegeneration, fail to predict the (non)effect. The amyloid model is not the only one out there, but it's a central one for very good reasons.
Explaining away this connection is not impossible - you can say that by the time these biomarkers are fixed the neurodegeneration is already well underway and irreversible - but it adds a layer of improbability (and would mean that the drug may work as a prophylactic).
What is more likely in my opinion (specifically intuition from what I learned and going over the clinical data) is that Alzheimer's is pretty wide combination of different and very entangled neurodegenerative processes, with different contributions in different patients. Thus, the drug only works well on a subset of patients (maybe, like I mentioned, only those at the very onset of degeneration), but we don't know enough to predict which, so for the entire population of patients you fail to reach significance. Scott shows repeatedly how we see this in psychiatric drugs, which sometimes only barely squeeze by placebo in global trials but doctors have good experience in finding the one that works for a specific patient (and not knowing why).
This approval will mean (a) Biogen, previously on the cusp of failure, now have a lifeline to investigate which kinds of patients the drug is good for, (b) it is released into the market, which means we will soon be getting efficacy data in big numbers, combined with genetic data.
Other avenues are now also more easy to explore - maybe you need combinations with other treatments, maybe the cognitive tests we use aren't the best (it's not like we had a positive control of a perfect treatment to benchmark them against!).
Overall, the scientific advisory committee was absolutely right in saying the clinical evidence is kinda crappy. But the cost-benefit analysis is still heavily in favor of the drug, as it is very safe, molecularly effective, and with no alternatives, in a very widespread and destructive disease. The only cost being some people paying money for a drug that won't help them, and the benefits are huge both short term (for the people which it will help) and long term (for better understanding and getting closer to more global treatments).
In class we placed bets on what would happen. I said the committee will say no, and the FDA won't approve. I've rarely been so glad to be wrong.
Basic Alzheimer's research is pretty insane, with everyone finding new degenative processes (nNOS decoupling and vasocontriction! Tau hyperphosphorylation!) and no one knowing what's actually connected to the cognitive decline and what just comes along for the ride.
Antibody treatments like aducanumab is a shot in the dark, taking one thing in this mess that seems kinda-sorta-consistent - the amyloid plaques - and hoping they stick as a treatment. Not really surprising that their clinical results are this messy. Of course we'll be better off as the basic research slowly advances, there's just the tiny issue of millions of people suffering *right now*.
Strong disagree. There are 10 anti-amyloid drugs that failed clinical trials in the past, some of which succeeded in removing amyloid. There should be a presumption that amyloid reduction does NOT cause a clinical benefit.
Your hypothesis that the drug will help a subsection of patients is plausible, but Biogen had 2 trials to find that group and failed to do so. They had every motivation to. To me, that signals the couldn't find a biologically plausible sub-group that had good results, that they were confident would replicate.
And "final proof of slowing cognitive decline" should be the only thing that matters. I don't care if a AD patient dies with a brain entirely free of amyloid. I (and you and taxpayers and doctors) care about cognitive performance. If Biogen, with billions on the line, couldn't devise a rigorous cognitive test that found evidence of clinical benefit, it isn't there.
The true tragedy of Aduhelm will be that the Alzheimer's Disease research space, which had begun to move away from the amyloid-centric hypothesis, is being effectively redirected to amyloid once again. Research $$ and healthcare $$ will be redirected towards a drug target that has done nothing but fail in clinical trials for 20+ years. The amount of wasted research and pharma money will be mindboggling.
You make a good point with the other clinical trials. My impression (with more the state of the basic science than the details of the other trials, which I admit I haven't dived into as much) is that even with them in mind, the amyloid model still has a lot of promise of being a causal part of the etiology, although I know there's disagreement there (even the instructors in my class strongly disagreed between themselves).
I don't agree that this will divert money and support away from other models. The research space in my impression hasn't so much 'begun to move away from amyloids' as it is 'continuously growing beyond amyloids into anything anyone can think of without really abandoning amyloids, which are still one of the few consistent things'.
Current therapeutic research, though, is kind of 'looking under the lamplight' - we attack the part that we finally we know how (amyloid) than other etiological hypotheses that may be very plausible but currently untreatable. I don't see how approving amab or not changes that. Especially given that it's such a huge potential market that anyone who thinks their non-amyloid treatment can do well on the cognitive tests can easily get support and push forward. My friend works in one such company.
Finally, I get your point about Biogen having had the opportunity to find a treatable population. But looking at the cohort it doesn't seem very selected for anything. So I take it to mean "harder than they expected and therefore hasn't been done yet" rather than "tried and failed so we should abandon".
I think that Alzheimer's and amyloids is kind of like depression and serotonin. Imagine if serotonin was really hard to treat and we didn't have the very lucky serendipity that got us today's drugs. If all we had to go on, like in this case, is a mound of basic research connecting serotonin to depression, and we took it and after a lot of effort (antibody treatments are really hard to get right) managed to rationally design several SRIs that do 'fix' serotonin but fail to squeeze past placebo (considering how close to zero is the global evaluation of SSRIs, with rationally designed ones doing no better than the ones we got by accident, it's not unlikely).
Does it immediately disqualify the entire serotonin hypothesis and any chance that SSRIs can treat depression? No. Instead, we get doctors who are able to match treatment to patient by trial and error, even without knowing why that's the case (which means that the pharma company also can't predict it for their clinical trials).
I think the main difference between this and Alzheimer's treatment history is that amyloid plaque treatment took a *lot* of effort to get right (you're not giving a small molecule that blocks a known protein, you're injecting an antibody - huge, expensive, harder to work with - hoping that whatever immune response it elicits will do the right thing and clear away the plaques).
I should note that yes, it forces us to look deeper into the serotonin hypothesis and realize the etiology is much more complicated than previously thought, just like happens with Alzheimer's and amyloids, but it doesn't completely disqualify the biomarker as a central part of the disease mechanism.
I think one of the Alzheimer's Foundation people made an analogy to the connection between LDL levels and heart disease. It was suspected on epidemiological grounds in the 50s, and a number of drugs were developed in the 60s and 70s that lowered LDL levels but failed to do much to prevent heart disease, and in some cases had excessively evil side effects. Even the first statins had a semi-troubled history, the development of copmactin was stopped after apparently causing tumors in animals, and development of the first statin actually released (lovastatin in 1987) was paused because of that.
It was probably possible, at a number of points in the 70s, for someone to say "look, we've given the interfering with cholesterol synthesis thing a try, and it just hasn't worked, four or five times, so we need to move on, and it's clearly wrong that inhibiting cholesterol synthesis will prevent heart disease." And it's lucky that that is not what happened.
That doesn't mean the hypothesis that clearing amyloid would help with AD is right, or that those who claim it's wrong are themselves wrong, but I do think complex biochemistry -- and the biochemistry of dementia is *really* complex -- is not the kind of thing that lends itself easily to straightforward conclusions.
If this were the first time someone had tried amyloid-reduction as a therapy for amyloid diseases, I might be on your side. It's not. This has been tried a lot of times before with identical results - less amyloid, same Alzheimer's. Indeed, even outside Alzheimer's they tried this with Huntington's and got "less amyloid, worse Huntington's" for their trouble (the disease effects of Huntington's are from free huntingtin; the amyloid lumps are the brain's partially-successful attempt to sequester it).
At this point, "amyloid-reduction doesn't do anything helpful" isn't just a null hypothesis but an outright consensus (to the point of satire like this https://blogs.sciencemag.org/pipeline/archives/2018/06/12/an-alzheimers-statement ). Anyone marketing amyloid-reduction without evidence of actual improvement in things we care about is at best irresponsible and at worst an outright fraud.
Your argument seems to read “sure it doesn’t actually treat the disease or benefit the patients taking it, but it treats biomarkers, and that’s what really matters!” But ... why should we care?
> You can say that amab IS actually completely useless in slowing cognitive decline, but then you need to explain why the different biomarkers, all with well-established connections to neurodegeneration, fail to predict the (non)effect
Because changes to part of a system can invalidate correlations you previously observed? Concentrations of a metal ion in urine is correlated with deficiency, but adding more ions to the urine won’t fix it. Liver enzymes in blood are a bio marker of liver damage, but I doubt a transaminase antibody will fix your liver! The marker and treatment endpoint not following each other means the marker failed, and you’re saying it means the endpoint failed.
> Your argument seems to read “sure it doesn’t actually treat the disease or benefit the patients taking it, but it treats biomarkers, and that’s what really matters!” But ... why should we care?
That's a pretty uncharitable reading. I'm not saying the biomarkers are what really matters, I'm saying that given the good effect on the biomarkers and the good research connecting them to the disease means we still have a good shot of finding that it actually does treat the disease (in some subpopulation/treatment regime/tests), even if current tests failed. That we shouldn't throw it out just yet. And this is one of the considerations (safety is another) in the cost-benefit analysis the FDA made.
Yes, this failure at the endpoint is an evidence against the marker, strong even, but it doesn't immediately invalidate all the previous evidence for it, no more than the reverse is true. And Alzheimer's research, like a lot of complex biological processes (think nutrition!), is very messy with new evidence constantly coming up in more directions that doesn't invalidate previous research. It just means the picture is more complicated. Maybe it *is* more like the urine ions in that it just comes along for the ride and not causal, but I think the probability that it's causal is still decent.
Why is there a good chance of finding that it helps treat the disease if the phase IIIs found that it didn’t? “Not throwing it out” doesn’t mean approving it ... even assuming you’re right and there is some point in continuing, shouldn’t you do more trials? I mean one was halted for futility. And adding that to the pile of old Alzheimers drugs with the exact same target that also failed makes it seem even less plausible it’ll actually be helpful.
Why is the hypothesis that amyloid targeting should work but hasn’t yet still the right one? When can we conclude it doesn’t work?
That said, I fully agree that we should uncouple approval and just allow doctors to prescribe it, not force insurance to pay for it. If the cost is "some people have the opportunity to pay for something that might not work" the cost-benefit is tilted one way, if the cost is "everyone has to pay for some people to get this experimental treatment" it leans another.
Even with the therapeutic progress I think this will help us achieve.
I mostly agree with your conclusion that "if you could only LOOSEN or TIGHTEN" FDA approval, loosen is the better choice and in the case of COVID-19, 95% of the FDA's mistakes were erring on the side of stritness.
But I think the story is a lot murkier for the AIDS drugs story than you think, and there is actually very solid evidence Aduhelm /won't/ work given the 10 other anti-amyloid drugs (semagacestat, bapineuzumab, solanezumab, gantenerumab, crenezumab, verubecestat, lanabecestat, atabecestat, umibecestat, & elenbecesta) that have failed clinical trials in the past.
Since that's is a long argument, I'll write it up and post on my substack and then ping you when I'm done, if that's okay.
We stopped doing the Red Scare even though there were presumably still Communist spies in the government so I'm more optimistic than Scott that the War on Terror could be ended.
Terrorists are more easily converted into "think of the children" than Communist spies are. Communist spies are only perceived as a threat to an average citizen if they're actively sabotaging things (in peacetime this is rare) or if the apparent probability of war, the apparent uncertainty of winning a war and the apparent gain from winning a war compared to losing it are *all* high enough that the chain of logic "if enough Communist spies succeed and there is a war, we could lose instead of winning and that would be terrible for my family" doesn't get dismissed at any point (also the person needs to be able to think that far ahead).
There were also more communist sympathizers & fellow-travelers in the government, which was why they were able to recruit such spies. Jihadists have never penetrated our government that highly (places like Pakistan would be another story).
I just meant that the whole purpose of their actions is to scare people into doing the thing they want. By its nature, that isn't secret. Conversely, the nature of spying is to stay undetected if you can, so if nobody goes out of their way to find you, they'll never know you existed.
Well, there's also the problem that it's hard to make people care about spying very much, even when it comes out in the open, unless it's included in a much more sinister package. E.g. the Snowden scandal died down very quickly without any policy change whatsoever. With China's pivot to capitalism and the fall of USSR the red bogeyman lost the vast majority of its relevance, these days the agenda is more about union busting and keeping Bernie from being elected.
There were never that many communist spies to begin with, so once people stopped bugging up the problem it faded from public consciousness. But past major terrorist attacks, and occasional minor ones in present and future, mean its something people will always think of as a major issue
Five stars seems like a high bar to clear. While I was reading the article, it occurred to me that a two tier system would probably get most of what was necessary. Approved with warning that risk is high/Approved with high confidence. Do you think that would be good enough?
I think you need a third tier: "Approved with warning that benefits are not yet proven". The two tier system still fails the fish oil test - we can presume that the +fish oil solution (or, to pick another one of Scott's go-to examples, melatonin) would be "approved with warning that risk is high", which would then place it in the same category as, I dunno, highly experimental hail-mary radiotherapy, and leave it all too easy for insurance companies to blanket non-cover the entire category for fear of side effects causing even more payouts down the road.
A category of "we can say that this is about as likely to kill you as anything in the Herbal Remedies aisle of your local Walgreens; though we also cannot say it's going to be any more effective than anything you find in the Soothing Wellfulness aisle of your local homeopathy joint" would at least signal to the insurance providers that these particular treatments aren't likely to affect the almighty bottom line beyond the sticker price of the bottle.
I agree with this post's overall point that the FDA is not, on average, too lax, and that the Atlantic article's take that the aducanumab approval is a sign of them being too lax is a bad take.
That said, I think the beginning of this article really undersells how uniquely bad the aducanumab approval is. It's not just "pretty unclear whether it actually treats Alzheimers." Nobody in the field thinks there's any serious possibility that it treats Alzheimers.
- The details of the "positive results" are textbook p-hacking of exactly the sort that the whole replication crisis has been about. It's a post-hoc subgroup analysis where the subgroup was selected based on similarity to the patients who had the most positive results; i.e., trivially guaranteed to show "positive" results via group selection. You can read more details in the statistical reviewer's comments in the advisory committee's document (PDF, starting on p. 174): https://www.fda.gov/media/143502/download
- Anecdotally, as someone who used to work in the Alzheimer's research space, nobody in the field seriously thinks the amyloid hypothesis is true. It's been tried, over and over again, every drug that's ever aimed at that mechanism has failed, it's busted.
It's fair to use this Atlantic article as a jumping-off point about how the FDA's approvals system is bad and lots of things get held up there for bad reasons. But I think you're really not engaging with just how bad the aducanumab approval is, and why.
In particular it seems like the whole analysis process got sidestepped by FDA leadership - the advisory committee were explicitly told not to consider surrogate markers! See committee member Aaron Kesselheim's resignation letter here https://twitter.com/akesselheim/status/1403675166803169283
Great piece. I’m mostly thankful the proposed solutions didn’t involve prediction markets or mitigating AI risk :)
I’d be very skeptical of insurance companies doing any kind of innovation. There’s obviously lots of details but even at a high level we can look at health insurance’s less regulated cousins - like P&C or auto - and it’s not like they’re pricing risk or creating products in a way anywhere near to what you’re hoping might happen. Fundamentally the insurance business thrives on aligning incentives more than it does pricing risk. There’s a lot of hype about the latter but we’re probably 5+ years from that shit becoming real and it won’t be lead by the health product lines.
But for two, I think it's seen as too much of a silver bullet in this community. I don't think they'll solve nearly as many problems as some people suppose.
Mother of all conflicts of interest - a company could just bribe all prediction market participants to vote the right way on their drug (either by paying participants or just dumping money in), and then recoup that massive expenditure with the 50k per patient approval revenue. And the market size can’t match that potential revenue for each new drug given the asymmetry of drug development - so many possible drugs and all of them fail. Idk though, maybe it would, im not sure.
Which is fine if you get a very high return for it and especially if asymmetries or frictions prevent people betting the other way from efficiently doing so,
General prediction markers are the worst one here, there are just so many more things that can be predicted than things that should be that you can’t have your whole market reasonably price all or even some of them. Like if you had a prediction market for how likely each person is to have a health risk, or reputation risk, or get or lose a job, that person has a massive advantage over every other market participant in that market, and as such can manipulate it and other participants can’t really stop them
Subsidizing the people betting the other way will attract more people betting the other way... which means you're unlikely to win. Nobody has enough money to buy the pot vs the rest of the world eager to take their money.
If you're trying to bid "George Washington will be elected President in 2024" up to 100%, sure, it'll fail. But if you're taking a drug whose true chances of success are 40% and trying to get it to the magic 51%? You can leave enough noise in the data that it doesn't look like free money to bet against you.
I mean, you could argue we’re already half there - futures and options and financial instruments and stuff are already kinda like prediction markets. It’s not as far fetched as it sounds.
A second-order problem caused by the situation is that, from what I can tell, no one *outside* the FDA has any motivation or bandwidth to think about anything other than “has the FDA approved this.” Pharma companies, doctors, hospitals, etc. aren't making independent judgments about what the evidence says, what risks to take, or how to make tradeoffs. There's no point, because they pretty much have to follow whatever the FDA says, positive or negative.
So instead of a million minds working on any given problem, we only the get the ~10k or so at the FDA.
"The problem was that people might stop trusting the FDA... If you model all FDA/CDC/etc policy as an attempt to avert this outcome, your predictions will be right more often than not."
And on that selected metric, how are they doing?
Do they even track it? Does anyone? Or 'public trust' just a placeholder, a dark matter acknowledgement that the math doesn't add up without some other motive in play... but do things add up with that motive in play?
The gold standard would be a repeated, regular check with stable methodology. There are two obvious recent polls - the Annenberg one in April and July '21, and the RWJ Foundation and Harvard TH Chan School of Health one in March '21. Headlines for them are opposite 'High trust holds steady' vs. 'trust is low'. Neither even attempt to answer how trust compares to 2019, let alone 2009.
It's hard not to wonder whether those hundreds of thousands of lives and 'limitless costs' are buying any public trust, or perhaps even eroding it. After all, the TSA has done wonders to build faith in the War on Terror.
And if the justification for being 'extraordinarily bad' at the job is public trust, and they aren't doing that either... what actually is going on?
The "people" in this case are not the American people, they are the 535 people up on Capitol Hill who set the FDA's budget, and who have the power to make the director's life miserable if they choose.
Now you would think that one of the way you keep a Senator happy is by not failing to approve some treatment that could save 5,000 baby lives a year in his state. But you'd probably usually be wrong. Even if the Senator hears from voters about this, that just means he gets to stand up on his hind legs and solemnly promise A Bipartisan Investigation Into This, and conclude (if the White House is not of his party) that the solution is to elect a President of his party to clean house at the FDA -- click this handy button to donate TODAY -- and (if the White House is of his party) that the solution is to create a new program at the FDA for Avoiding Baby Killing Nonapprovals and boost the budget of the FDA by $50 million to pay for 100 lawyers and 2 MDs to staff it. You'll note that either way the FDA career staff need have no fear of the outcome.
On the other hand, if the FDA approves thalidomide, and the White House belongs to your party, you're really screwed. That's the kind of thing that totally loses elections.
This sounds like a (and don’t get me wrong i hate this shit) messaging problem! Someone needs to figure out his to get all those dead babies on ~~prime time television with Anderson Cooper solemnly narrating a tear jerking sob story~~ nah it’s 2020 find some tiktok stars with family members who got the short end of the approval process roulette and can explain why the memory of their dear and dead father would be best honored by the passage of the conveniently already drafted senate bill 350! If structural problems mean one FDA incentive is inflamed while another is neglected, just make some new structures!
Ideally it wouldn’t be like this, but then again what is this blog doing now if not a less cynical version of the above - if Scott isn’t thinking reform then certainly the hundreds of DC policy people who read this blog and have commented on Twitter about how awful this is are.
We need a wartime FDA and CDC. “First, do no harm (and don’t get sued)” has some issues, but is understandable in “peacetime”. Maintaining that attitude in an actual pandemic is neither understandable nor forgivable.
The difficulty here is that it's always wartime for someone. If my baby was in the hospital slowly starving to death I would be more on wartime footing than I have been the last 18 months.
Pretty good article. My favorite FDA story, which may be apocraphyl alas, is that supposedly you can't test combination therapies unless *all* the ingredients are already approved, which means a lot of potential synergies (which we know sometimes exist) will remain unexplored, because one of the components isn't already approved. As in, X did some good for metastatic breast cancer, and Y did a little good but not enough to exceed the standard of care and so didn't get approved -- and now you can't test X + Y to see if it outperforms everything. Boo.
By the way, I think the only legal mechanism by which insurers end up having to cover stuff the FDA approves is tort lawyers. I don't *think* it's built into any statute, although that might have changed under Obamacare, which set new standards for insurance plans. And I also thought whether Medicare covered stuff was decided by the CMS, which in principle is independent of the FDA. But realistically, in the highly litigious, highly suspicious political air in which we live, *everyone* in all those places is in full CYA mode all the time, and the result is what you observe.
I'm very dubious about your proposed reforms being implemented. They remind me of the endless proposals for voting reform proposed by libertarians and other minority parties, which can't be explained in a Tweet unless you have IQ >115 and which therefore uniformly fail (or when they pass, cf. NYC's recent election, just baffle and annoy most people).
There is a far more radical and yet simpler approach, however: get the government out of paying for healthcare directly, eliminate employer tax deductions for healthcare so it stops being a routine employer benefit (and employer choice), and get the government out of the business of setting standards for insurance plans (except insofar as they might mandate outside review of claims, quadrupole damages with executive horsewhipping for strategic or stupid denials).
The point being, if people have to decide for themselves what the cost (literally, in their own precious $$$) and benefits are, history suggests they will be surprisingly canny about that. You want to buy a smartphone, there are a million private resources that will gather all the critical info you need, and people use those things. Even the dumbest among us don't turn up at Home Depot to buy a new washer without having read the reviews. So we would expect the voters and healthcare consumers to become a lot better customers of high-quality information about the relative value of drugs. Whether that information is provided privately or by a government agency might be largely besides the point, if the key criterion -- which is that the information is consumed by, and used by, and important to, the very person who will spend the money and take the drug -- is in place.
> By the way, I think the only legal mechanism by which insurers end up having to cover stuff the FDA approves is tort lawyers. I don't think it's built into any statute
If those tort lawyers win their cases, that means that either
1) if the insurance contract explicitly excludes certain treatments, there is some statute that says that such a clause is unenforceable
2) courts have decided that such a clause is unenforceable even though no statute says so (in which case a statute needs to be made to tell the courts to knock it off)
3) insurance companies don't actually offer such contracts, and they end up having to cover ~everything because the contracts say they have to cover ~everything.
My impression, and I'm not a lawyer, is that insurance contracts routinely exclude "experimental" therapies for conditions treatment of which they otherwise cover, and the legal case revolves around the interpretation of "experimental." The insurance company uses "not approved by the FDA" as a pretty reliable proxy, and if they're deprived of that fig leaf they need to make a much harder case with expert witnesses and so forth.
HillaryCare was going to explicitly take away people's ability to sue for non-coverage of care, and it was just one reason (there were plenty!) that it got sunk, because people want everything covered.
I wouldn't be quite that cynical about the American healthcare consumer. I think most people are reasonably OK with a given plan not covering absolutely everything -- as long as they're very clear on what is and what isn't in.
What I think gets their blood boiling, and not unreasonably so, is when they make a good-faith effort to figure out what's in and what's out, and end up screwed over anyway.
For example, most plans cover "emergency care" in the ER at near 100%, or with a very modest copay (like $50-100), although the actual tab can easily be enormous. But what is "emergency care?" It has traditionally been defined as what a reasonably cautious and intelligent layman would *think* is an emergency, e.g. chest pain, bleeding you can't stop at home with pressure, sudden numbness in your limbs, a sky-high fever and violent vomiting.
Recently some bean-counters at UnitedHealthcare had a brilliant idea: hey, how about if we only cover ER care if it's an *actual* emergency, meaning when you get there the chest pain *actually* turns out to be a heart attack and not GERD or a shoulder injury with referred pain to the sternum. We'll save tons *and* discourage people from going to the ER when they could just as well wait until the next morning to see their PCP for an office visit...
As one might imagine, they got a *lot* of blowback about that, with people quite correctly pointing out that some of their customers would actually die for fear of being charged $40,000 for gas pain they thought, being regular schmoes, might've been the MI that killed their fathers -- and haven't we been stressing in PSAs for years that people should NOT wait if they have classic signs of a heart attack of stroke, because time = life?
I believe they've put the rule change in abeyance for now, but that's where they'd like to go, and you can see why it infuriates people. How do *I* know if it's a genuine medical emergency, if I'm not a doctor? Why do I have to roll the dice like that, heads I snuff it through overcaution, tails I'm on the hook for a five-figure bill? Can't you just give me some very clear, easy to read, comprehensible to IQ 90 in a panicked state, definition of what you do and don't cover?
Of course, that doesn't seem to me to be easy as pie, but it does seem likely they could do a better job, if it served their interests to do so. If you ask me, this would be one area where government regulation could improve things at a modest cost, just compelling plans to be much clearer about what's in and what's out, perhaps using the cudgel of requiring any ambiguity to be resolving in the customer's favor.
Oh, I have no doubt insurance companies are untrustworthy. (And hospitals will say "everything is covered" and then the anesthesiologist will send in a $20,000 bill and the hospital will say "well, duh, the anesthesiologist is an independent contractor, you dummy.")
But even good-faith attempts to explicitly say upfront "radical chemotherapy isn't covered" end up getting covered anyway, because it was just one paragraph in a 100-page contract.
Insurance companies should publish machine-readable descriptions of their plan so that anyone can figure out what is and isn't covered.
I'm neither surprised nor upset that their untrustworthy. People in general are untrustworthy, except the few that are your family (usually) and friends (if you pick well). People routine defraud insurance companies, and routinely try to work the healthcare system for all kinds of noxious purposes (drug-seeking, bogus disability). That's just the species we are.
But I do think it would help in general if we spent social effort on just making these kinds of complex deals simpler and clearer. Maybe it isn't that bad of an idea to have some kind of greater standardization of healthcare plans, so people could learn the ropes and take that knowledge with them as they move around and grow older. I do think some kind of government mandate on clarity and published descriptions would help. Maybe some kind of consumer committee that is empowered to compel the company to rewrite its plan descriptions, or submit answers to clarifying questions the committee poses, maybe some kind of legal requirement that the plan maintain a subscriber info 1-800 number staffed by people who can and must answer questions related to coverage clearly and accurately within 24 hours. Not sure -- this is an area of endeavour to which the natural skills of lawyers could be directed, so they stop being pestiferous in other areas.
I did laugh! Although many things, some of which were government mandated infrastructure changes, have significantly reduced road deaths in the past 50 years, and we really should do something about whipped cream.
What's the deal with challenge trials and vaccine approvals? Most of the time I see it discussed with the assumption that challenge trials are currently illegal (but they shouldn't be). But challenge trials definitely aren't categorically illegal, at least not everywhere in the world—several of them have been done for various diseases in the last few years. And even if the US doesn't allow them, there are most likely countries I'd expect to be less squeamish (such as China), but I'm unaware they did them either. More generally, no country started mass vaccination until December, even though China started vaccinating a small number of people in the summer (based on weaker evidence rather than challenge trials).
Are we sure it isn't because it took until December for vaccine manufacturers to build mass production capacity, so faster approval wouldn't have mattered anyway?
Also, why did vaccine manufacturers not produce large amounts once it was pretty sure that their vaccines would be approved, ready to use the moment they were approved? The charts of vaccine doses administered definitely suggest this wasn't the case: they started trickling in December and January, and gradually increased over the next months, rather than starting off with a large jump right after approval. This seems to suggest that production was the bottleneck—although I don't know if the lack of challenge trials delayed when the manufacturers became confident enough that they would get approved to invest in manufacturing capacity.
Earlier approval would have mattered because the time at which production capacity is built is not fixed. It would not make sense to build a facility that would sit idle, or to produce a lot of vaccines that will just expire before they can be used. And I can't speak for other countries, but where I live in the US the initial administration of vaccines was limited to subsets of the population. expanding over time to permit more people (and even the distribution of those, handled by state governments, left much to be desired).
I recall reading that Bill Gates started funding factories for several vaccines before the trials were finished, so that whichever one panned out we'd have a head start on production.
Pfizer and Moderna vaccines have an (approved) shelf-life of 6 months. Staring manufacturing in September, they could have made a large amount of doses that would have still been usable for 2 months after a December or January approval.
> the initial administration of vaccines was limited to subsets of the population
That shouldn't have limited the number of doses administered. Vaccination was limited to subgroups because vaccines were scarce. With more vaccines, the vaccination of those groups would have been completed faster, and vaccination could have been expanded to larger groups earlier.
Challenge trials in China get you no closer to approval in the US and EU. And challenge trials in the US and EU, while not explicitly barred by statute, are so far outside the norm that you'd pretty much have to develop the procedures and recruit the team from scratch, with opposition from people who consider the concept fundamentally unethical but won't quietly resign when you say that your organization is going to be doing challenge trials this time. Absent strong leadership and commitment of resources from the top, that's going to take enough time that you're not likely to come out ahead of doing the usual sort of clinical trials that the entire industry is already set up for.
As for production capacity, it is remarkably hard to figure out just when Pfizer, Moderna, et al went all in on building mass production capacity, but it is quite plausible that TGGP is right and that they were aiming to ramp up production at about the most optimistic FDA approval date using normal clinical trials. So it is possible, but not certain, that if we'd had a POTUS or an HHS head who could push aggressively for challenge trials, we might have had large-scale vaccine deployment a month or two earlier.
> Challenge trials in China get you no closer to approval in the US and EU.
But they get you closer to approval in China (and likely several other third-world countries, perhaps even in borderline first/third world countries like Hungary).
My point is, if challenge trials would have been useful, I'd expect that China would have done them with Chinese vaccines, for the Chinese people, and perhaps for export to some less strict countries.
I can also imagine that if several third-world countries had successfully suppressed the epidemic starting from last summer using Chinese-tested vaccines, it would have even created considerable public pressure to allow their use even in Western countries. And it would have been a major PR victory for China, showing Western governments as impotent.
Strongly agree with most of this article. Work at a biopharma and it's so annoying how expensive and slow the process for bringing anything to market it. What's most shocking is always how much the doctors and even internal employees internalize the FDA mentality that you'd let 10,000 people die from approval delays vs one person go to the hospital from an unintended side effect. It's not true that insurance companies cover everything. There's some spaces like obesity where they cover next to nothing (I think semalgutide will be different) and very often they won't cover new medications when there is a cheaper older medication esp if it's generic. Lots of times people also need prior authorization for treatments and insurers can just say this isn't serious enough. I think you could see that happen here. The big issue is though that everyone 65+ qualifies for Medicare, most of those people buy Medicare part D (prescription plan) and Medicare does legally have to cover everything at any price because the pharma lobby owns half of the Democrats and every Republican. This means the government will end up paying biogen billions per year. Also since there aren't really any Alzheimer's drugs it's very hard for an insurer to refuse to cover the only treatment available. The issue here though isn't the FDA. It does do an amazing job at getting rid of amyloid and it's safe. In an ideal world we should be okay saying doctors are allowed to prescribe medications that are safe and possibly effective. It's actually quite dystopian to say we should be arresting people or banning them from their professional for giving people treatments that are definitely safe and may be effective. Maybe then we should just stop giving out research grants because not every project is successful. The problem isn't with the FDA it's with doctors and moreso insurance companies being spineless and covering everything which is really a problem with the legal system. No doctor wants to be hung out to dry for not prescribing a well publicized approved medications just because he had some skepticism and then the family goes after you for malpractice and insurance companies can't afford to be evil boogeymen for refusing to pay $50,000 a year for a drug that may not work and even if it did work have very modest benefit. Also the doctor makes money prescribing the drug and the private insurer makes money covering it because minimum MLR ratios mean the only ways to make money are to spend more on patients or cut down on staff, and spending more is really easy! You cut down wasteful hospital and prescription spending? Great job now give everyone a rebate!
> There's some spaces like obesity where they cover next to nothing (I think semalgutide will be different)
To be fair, treating obesity with drugs just seems wrong. There are some very clear dietary interventions that should happen first, and if the state is paying for the obesity drug the state should instead pay a lot less to (on the producer side) implement that dietary restriction.
> In an ideal world we should be okay saying doctors are allowed to prescribe medications that are safe and possibly effective
But it isn’t effective, and we know that. This isn’t the first Alzheimer’s antibody that failed, and it’s not even one of the first thousand treatments that targeted the wrong molecule or protein or function, modified that, but failed out of some large or small misunderstanding or issue
Dieting doesn’t work (mostly because people don’t stick to the diets, or modify them). A mandated slicing of added and processes (in the sense of making more isolated and concentrated) sugar and starch and fat as well at the producer level would (carbs are not better than fat and sugar). Might have to ban those delish sugary breakfast muffins and fatty coffee drinks!
You could argue that’s an abuse of govt against freedom, or argue that not doing that is a population scale crime against health and dignity.
The War on Drugs via prohibition failed; the War on Alcohol via prohibition failed badly enough that we don't even call the War on Drugs "prohibition" because it would discredit it. But you think we can win the War on Tasty Food, one of biology's top-two urges, via prohibition?
Sugary food isn’t drugs. The food conglomerates can be regulated in ways that Mexican drug dealers can’t. And it’s not a ban on pizza, just ingredient restrictions, which already exist for other reasons. It’s also significantly reduce like ten of the top public health crises in the country, reduce medical spending and suffering by. Lot, and improve the lives of a hundred million people and save ten million from crippling and painful disease. But I mean, freedom good, government bad, war on drugs bad, regulation is never possible rite
The part your missing is that someone who looses weight through dieting can end up with a metabolism that requires hundreds fewer calories than someone else who hadn’t been heavy. If I modified your gut bacteria to make it more efficient such that you had to eat 700 fewer calories per fat to maintain your weight I’m certain you wouldn’t be able to stick to a diet that would maintain your weight.
If I modified your gut bacteria to make it more efficient, such that you had to eat 700 fewer calories to maintain your weight, I’m certain you wouldn’t be able to stick to that diet.
I personally easily do stick to whatever diet I want, and have done both significant and extensive fasting and year long very unpleasant dietary changes. Pretty sure I could.
Regardless, all this needs to do is cause people to lose significant weight, which I believe it would (forced dieting does cause weight loss, and this is like that except via the sort of consumer regulation that is standard everywhere). Do you think that this wouldn’t lead to significant improvement in weight for most?
> It's actually quite dystopian to say we should be arresting people or banning them from their professional for giving people treatments that are definitely safe and may be effective
Why? Is it dystopian that a restaurant can be shut down for serving food with hair in it (hair isn’t harmful...). And IG Farben did SEVERAL studies showing that parathion was ENTIRELY SAFE for human consumption so it is a violation of my dignity as CEO for the pesticide to be banned and deprive millions of poor farmers of their god given right to spray it on their fields, likely putting thousands out of business due to lost crop yields. 1984! Newspeak! Book burning!
Seriously, it’s hard to look at large scale prescription and not think that the FDA regulating medication effectiveness is probably somewhat good because otherwise a lot lot more people would be taking medications that are ineffective but are claimed as effective. That’s what happened pre FDA!
Yes, it is dystopian that a restaurant can be shut down for serving food with hair in it.
LOTS of people take medications that aren't effective and we already have the FDA.
Do you really think that the whole world was buying "Maggie's Snake Oil" prior to the creation of the FDA?
Just like they were all drug addicts before the war on drugs and alcoholics before prohibition and the murder rate was much higher before the first gun control laws.
You imagine a perfect FDA that never was and never will be and compare it to a dystopian past that never was and declare on balance that the FDA is worth it.
Yeah, but a lot less! And the ones they do take that are useless are often contextually useful but useless in a broader sense, while still bad - as opposed to lead acetate.
Yes, it was pretty bad back then. Medicine also was just a lot less developed, so nobody knew how to tel the difference, but most treatments did not work and those that did not well. Way different.
I’m saying the FDA is better than no FDA or a general assumption that, say, a company’s own trials prove it’s ok to prescribe or docs can in good faith prescribe any synthetic compound if they feel like it
Are there any randomized controlled trials of randomized controlled trials vs other techniques for establishing safer and effectiveness? And if not, why should I trust a technique that can’t bootstrap itself?
The problem with making it so insurance companies can pick and choose what they cover is that health insurance largely stops functioning as *insurance*, unless the optional category only includes treatments way at the margins, in which case it probably doesn’t make much difference. As someone who isn’t a doctor, I have no ability to evaluate a list of treatments and understand what that means for my expected medical experience, because I have no knowledge of what the probability distribution is for health problems I might have in the future (especially once you get beyond high-profile things like cancer). The whole point of insurance is to trade decreased expected value for decreased variance, but unless coverage is approximately everything, I can’t properly evaluate what the variance benefit I’m getting is (but the insurance companies can and will do so to their advantage).
Personally, I think the most long term stable setup is a single provider system like the NHS in the UK, where the organization that sets the standard of care is the same as the one that pays for treatment, because they’re forced to reckon with cost and benefit in one place. This results in some idiosyncratic standards of care (eg, mammograms every 3 years starting at 50 in the UK instead of every year starting at 45 in the US), and obviously they make plenty of mistakes, but overall seems like it results in a workable system.
I think right now health insurance barely functions as insurance. Sometimes people talk about a product called "catastrophic insurance" which would cover extremely serious things like cancer, etc, but not your regular checkup. The idea would be that this is pitched at middle class families who could maybe cover $5,000 worth of expenses but not $50,000. AFAIK this is somewhat illegal now, and health insurances have to cover everything including everyday stuff.
If insurances were allowed to choose what level to cover things at, it seems like you could get everything on a spectrum to "we will cover literally every medical expense you have" to "we will only cover the most severe conditions".
It sounds like maybe your concern is that an insurance could say they're not covering, eg, certain expensive conditions, and people who are thinking very short-term might get that insurance because it's cheaper and they figure they'll never get the condition? I think that only makes sense in our current system where you're mandated to get some insurance, and lots of people who don't want insurance just grumble and get the cheapest thing they can. If you actually wanted insurance, for normal insurance protecting-against-extreme-bad-outcomes reasons, wouldn't you not buy something that didn't cover serious conditions?
The problem is that I don’t know enough to adequately evaluate whether any health insurance product actually covers all things that might be expensive if the insurance company is allowed to pick and choose what is covered. I don’t even know the list of things to check. If an insurance company says that they cover these three treatments for skin cancer and these four for heart disease and these two for Alzheimer’s and this one for Parkinson’s, etc, I can’t evaluate the likelihood that that leaves me in the lurch when I have some medical problem without basically going to medical school. The only product I can buy with confidence is one that says “We cover everything reasonable”, and “everything reasonable” has to be defined by some third party because otherwise you have the original problem of the insurance company getting to define it in a way that’s advantageous to them.
I think it’d be fine to have a product that excludes things like checkups or cheap stuff and only covers severe conditions, but when you get to the point of the insurance company getting to select parts of the severe conditions umbrella to cover and not cover others, the buyer can’t accurately evaluate what they’re buying.
> If an insurance company says that they cover these three treatments for skin cancer and these four for heart disease and these two for Alzheimer’s and this one for Parkinson’s, etc, I can’t evaluate the likelihood
Neither can I, but there are lots of consumer-reports-style people out there who will parse it for me.
> Sometimes people talk about a product called "catastrophic insurance" which would cover extremely serious things like cancer, etc, but not your regular checkup...AFAIK this is somewhat illegal now, and health insurances have to cover everything including everyday stuff.
For what it's worth, this used to be a thing in many states, pre-Obamacare. Usually they were the states with the cheapest medical costs by a good margin, as well. Conversely, the state used as a model by Obamacare (Massachusetts) was the second most expensive one.
This isn't very different from the current HSA/high-deductible plan, which is one of the best innovations to accidentally come out of government in decades.
The chief problem with your plan is that if someone decides to buy catastrophic insurance and ends up with something that doesn't meet the criteria for catastrophic but they also can't afford to treat the public doesn't have the balls to let them suffer.
"wouldn't you not buy something that didn't cover serious conditions?"
Again - bad actors. Our insurance covers everything* What have we seen with those christian sharing ministry health insurance scams?
* blah blah blah by everything we mean nothing.
What you didn't read the entire 570 page policy? Well if you did you'd know we don't cover brain tumors. So you only have yourself to blame.
"We'll cover everything that our top-tier insurance covers, but there's a $50,000 annual deductible" seems like a pretty sensible form of catastrophic insurance to me.
$50,000? So if you get MS and the treatment is $50k a year what percentage of Americans do you think could swing that? In these debates about catastrophic insurance the proponents seem to be entirely unaware of expensive chronic conditions.
What's the median income for a family of 4...$79k. You have mortgage, car payments, gas, utilities, retirement contributions, etc. If the disease was $20k/year where are they going to come up with the money for the first 5 years?
I think this is just re-inventing "pre-existing conditions." It sounds logical in theory - "you need to get insurance before you get sick, not after, and if you didn't get insurance, I guess you didn't care about the risk" but in practice it turned into "I did care about the risk, so I got insurance, but then I lost my job and my coverage lapsed, and my new insurance won't cover my medication because it started under the old insurance company."
The combination of "chronic medical issues exist" and "you can't pay without insurance because of Yagmuk-related pricing shenanigans" means that health insurance doesn't just serve as a risk-manager for catastrophes, but also as the means for buying everyday medical care.
As long as that problem exists, the question of "is insurance providing the right balance of risk tolerance and price?" is going to be impossible because you're not paying for risk management, you're paying for someone who can negotiate to get your bills sent to Yagmuk.
>The idea would be that this is pitched at middle class families who could maybe cover $5,000 worth of expenses but not $50,000. AFAIK this is somewhat illegal now, and health insurances have to cover everything including everyday stuff.
Isn't this just high-deductible health plans? That's what I have. It costs a couple of hundred a month, I use what would have been premiums to fill up an HSA. I think we're 3000 deductible with various co-insurance after that until we hit 5 or 6k, which is our out of pocket max.
It still doesn't make me price discriminate though. There's plenty of cash in the HSA for health costs and it comes off a separate card. I couldn't spend it all in two or three years even if I stopped putting money in, because of the out-of-pocket max, and I've never hit the out-of-pocket max in the three or four years since we switched to it.
As a Brit I wouldn't describe the NHS as offering idiosyncratic standards of care. The true state of the NHS is far worse and I wouldn't recommend anyone adopt it.
Consider that the NHS at this point has essentially collapsed. Nobody is talking about it because the UK is always in a sort of collective state of denial about the NHS, and as an arm of government it has no clear end point in the way a private sector organization would. But measured by any metric other than existence, it has collapsed.
The proximate cause is lockdowns and everything that went with them. The NHS was seriously struggling to handle case load even before COVID but then people were told they had a patriotic duty to NOT go to hospital, and because one of the effects of nationalizing things is a whole lot of people became super emotional about it, lots of people took that order to heart. Also lots of people were told that hospitals are COVID death traps so stayed away for that reason, and finally the NHS implemented a "pingdemic" that caused huge numbers of workers to be told to self-isolate because their phone detected a Bluetooth signal of someone who tested positive. There is now a backlog of delayed treatment so massive that there is no possible way it can ever be cleared except by lots of people dying whilst waiting to be seen. The NHS cannot scale up capacity to treat this backlog for several reasons but one is because there are no market signals anywhere, so the NHS is near-totally unresponsive to changes in demand. Also because of how regulated approval of doctors is and that training is fully state managed, that's also unresponsive, e.g. there's no great way to train "half doctors" who are only capable of treating a subset of problems. There's also been a lot of grade inflation around approval of nurses. As a consequence the NHS is incapable of training the workforce it needs locally and has managed by "raiding" developing countries of their medical staff, on a massive scale. During lockdowns and border closures this way of hiring was shut down, exacerbating the problem.
Another NHS specific problem is that it basically refuses to spend money on capital projects like site upgrades. Whenever it's given money by the government it tends to spend most of it on wage increases even as buildings leak and equipment rots. The problem got so bad and the works backlog so massive that the government tried allocating money with earmarks attached so legally the NHS has to spend it on capital, and even that didn't work, the NHS mostly just ignored the law and spent it on staff anyway. The government can do nothing because the population incorrectly associates "NHS = doctors/nurses" and thus freaks out at any criticism of it, because they think anyone who says the NHS sucks is saying that brave heroic carers suck. So the NHS has become this kind of self-ruling branch of government that is totally unresponsive both to patients and also democratically elected leaders.
"The true state of the NHS is far worse and I wouldn't recommend anyone adopt it."
On the Tube you see tons of ads for supplemental insurance that gets you access to among other things HCA units in NHS hospitals and independant HCA and other non-HCA hospitals. (HCA - Hospital Corporation of America.) The cost of these policies is fairly minium I think they start at something like $50/month. The vast majority of brits don't bother to buy one. If things were as bad as you say that wouldn't be the case.
Firstly, BUPA alone has 2.2 million customers for their private insurance in the UK. Private health insurance isn't that rare, even though it's not talked about much.
Still. One reason low relatively low uptake is that private health care isn't hugely useful in the UK, because the NHS squeezes out most of the competition leaving private hospitals to compete mostly on quality of care issues, and that in turn throttles private hospitals - they actually can't handle quite a lot of the most complex and difficult surgeries, because they can't compete with "free".
Except of course, by offering lower waiting times. Whilst the NHS has had various waiting time crises in the past, they eventually attracted political attention and been resolved (sometimes at the cost of creating new problems elsewhere). But they've never reached the staggering scale they now have done. Perhaps the situation w.r.t. private healthcare adoption will change? If you're seeing lots of ads, apparently some insurance firms are anticipating increased demand. I never used to see many ads for private healthcare when in the UK.
The final issue is the previously mentioned quasi-religious aspect of the NHS. It's scarily irrational. Try having a conversation about the best private health insurance in a mixed group of Brits, say it's because you don't think the NHS is good enough and see what happens. The NHS is often called the "national religion" because too many people act like criticism of the NHS is criticism of an actual god. Any private firm would struggle to compete against a fully tax funded state run organization, but when you add in that aspect, it's amazing there are any private hospitals at all.
"Still. One reason low relatively low uptake is that private health care isn't hugely useful in the UK, because the NHS squeezes out most of the competition leaving private hospitals to compete mostly on quality of care issues, and that in turn throttles private hospitals - they actually can't handle quite a lot of the most complex and difficult surgeries, because they can't compete with "free"."
That summarises to "NHS good". You have admitted that they can do complex stuff that the private sector can't, so that's one version of "good" , and that they ar cheap , do they squeeze the private sector on price , which is another version of "good". Would that the US had some force pulling down healthcare costs!
The private sector *could* do it obviously, they're all recruiting the same staff.
The NHS is not cheap, it's taxpayer funded, which isn't the same thing. The closest model is if the government picked a single company that both runs hospitals and runs its own insurance scheme, then forces everyone to become a customer whether they want to or not. That company would immediately become very stagnant and bad at its job, and most people would still use it anyway because going to a competitor can only increase their costs but never decrease them.
The UK spends half as much aon healthcare as the US for similar results. So the NHS is cheap, by empirical evidence. Your argument that it must be bloated and inefficient is a priori.
Maybe we just need FDA Pre (analogously to TSA Pre) to grant people who are background checked and have given informed consent access to unapproved drugs?
I find it interesting how your proposed 1-3 star rankings look a lot like phase 1-3 in the approval process. So if you compare this to what we have now, the major changes are:
a) Doctors who are expert in a specific field can approve drugs after only a phase 2 trial,
b) Drug companies can't advertise a drug until it's been in the field long enough to get 4*, and
c) Insurance companies are obligated to pay for far less stuff.
This is both wise policy, and the single least popular package of reforms I can imagine which would fit in a single tweet.
Agree with almost all of this, except (somewhat predictably) some of the COVID related stuff.
The small number of apparently honest that look at the NPIs all conclude that none of them correlate with outcomes at all. That includes contact tracing. The only human action that seems to have any effect is vaccines, and even then, only on severe outcomes, not on transmission or mild infection. You assert that Taiwan is a success case for aggressive contact tracing, but in reality they ended up having a recent outbreak anyway and it's really not clear what causes the different time series between countries. Taiwan in particular only seems to test very ill people, as evidenced by their sky-high CFR compared to other countries, and up until recently was basically not testing at all. Everyone likes to read a pet theory into the timeline of a few countries, but these always seem to break down when analyzed against the whole dataset.
The FDA's concern that uncalibrated tests can lead to false positives is at least a genuine one. PCR tests are often claimed to have no false positives, but in reality they can have extremely high FP rates. Medical "science" has fixed this by defining COVID as having received a positive test, which is why they normally claim the tests don't have false positives (gotta love circular logic). E.g. one study found that in 70% of PCR positive samples it was impossible to culture the virus, implying there was no viable virus in the sample and thus that the lucky winner of the positive test wasn't infectious.
FPs have real consequences. Not only the obvious one of confining harmless people to their homes, wrecking travel plans etc, but also by contributing to the rapid degradation of trust in institutions. When scientists claim the tests have no false positives and then make claims on the back of this idea (like calculating re-infection rates based on the assumption that two positives cannot possibly be one true and one false), it worsens people's trust in all science. Lab challenge programmes in pre-COVID times have shown PCR testing to have anywhere between 1% and 15% FP rates, and lab challenges can be done by literally anyone who submits a sample to a PCR lab using a home testing kit. There are or were lots of videos circulating on social media of people who swabbed a puddle, their dogs ass, or nothing at all and then getting back a positive result. Not surprisingly people when people then ask, "well what's the true FP rate?" they discover that governments and scientists are claiming there are none. This leads inevitably to conspiratorial thinking, or at the very least, a sudden willingness to question all medical authority. Exactly what the FDA is trying to avoid.
Does that justify the FDA's stance? No. It would be better if the FDA was privatized and became a charity or something, using kitemarks+trademark law to grant approval of treatments. They've made tons of mistakes. But the underlying problem they were trying to avoid is now biting society on the ass.
> The only human action that seems to have any effect is vaccines, and even then, only on severe outcomes, not on transmission or mild infection.
Bluntly, this is nonsensical. Look at how fast cases fell, even as countries re-opened.
Heck, even NPIs can clearly work, insofar as the population actually does them. The whole "wave" structure was 100% based on the fact that people loosened up when cases were low and clamped down when they were high. That tells me that clamping down is effective, even if a governmental Official Clamp-Down Mandate might not be.
I don't quite follow your argument. Yes, cases fell even as countries re-opened, rather implying the restrictions weren't working, right? Hence the recent blowup in the UK where "experts" said ending restrictions was an unethical expert on the entire world and there'd be hundreds of thousands of cases, and then cases dropped off a cliff. If the restrictions were really keeping cases in check that couldn't have happened, but it did.
Cases fell as countries re-opened *during the period where vaccines were being given out en masse*. That means vaccines work better at limiting spread than lockdowns, but it doesn't say anything about lockdown effectiveness per se. (I tend to think the mandates did relatively little, but this isn't much evidence of that by itself.)
Maybe again I don't quite follow your argument. Can you please lay out again the chain of logic you're using because it just seems totally wrong on its face.
Go to Google and enter "uk covid" to pull up case and vaccination curves. They're embedded right in the search results page.
The UK's most recent wave started on about 20th May. At that point 56% of the population was vaccinated with at least one does and about a third with two doses. Vaccination was proceeding apace. A month later those figures were 64% and 47% respectively. The summer wave peaked around 21st July, almost exactly 8 weeks after it started. "Freedom day" was on the 19th July. Literally, two days after the restrictions were released cases started falling, in flat contradiction of apparently every expert prediction. There was an open letter signed by 1200 "experts" stating that cases would explode once restrictions were removed. Every single one of them was dead wrong and wrong in the wrong direction.
If this event cannot falsify your belief in lockdowns then I'm really curious what could?
There's a few distinct things happening, and the sequence differs between different countries. This does, admittedly, make the results a bit messy.
1) Public worry at the high case counts of last winter, lowering transmission.
2) Mass vaccination, lowering transmission.
3) Delta, increasing transmission.
4) Reopening, increasing transmission.
All of these will affect case counts in various ways. My claim is that #2 and #3 are the big ones, and #1 and #4 have relatively less to do with the changes we've seen in the last 5-6 months. In countries that vaccinated first, like Israel, we saw cases plummet, even as things reopened and the public was clearly loosening up. However, Delta came along soon after and reversed that progress (at least, re: case counts - serious illness is still pretty low). Indeed, some countries that had kept things well controlled for the first year saw their control systems break in dealing with Delta, because those countries were often very slow to vaccinate.
I confess that I haven't looked at this UK case in any detail. However, note that I think official government lockdowns are largely ineffective, because what actually matters is how people act, not what governments order. We don't live in police states, and I'm not convinced that those orders are complied with very much - the people who'd lock down anyway are locking down, the people who wouldn't aren't.
There's at least one other possibility that fits your data and assumptions: COVID transmits very easily, is largely invisible for most people (asymptomatic or just minor cold/flu like symptoms), and most people don't get tested such that we never knew they had COVID in the first place.
In this case, vaccination works along side a very high immunity from having already contracted and recovered. The effectiveness of the vaccine apart from having already had COVID is a little hard to disentangle since we don't know how many people had antibodies already before they got the vaccine, but the vaccine helps in either case.
Countries that locked down more saw less growth in COVID cases, partially because locking down worked and fewer people got it and got tested, but also because people who had minor cases figured "Just the flu, couldn't be COVID because I am locked down," or just couldn't get tested one way or the other because doctor's offices were locked down. (That was the case in PA, strangely.)
Downside of locking down, the slower growth in cases meant there was a longer store of fresh meat for the virus to infect, so cases kept popping up, stretched out over time. We rationed COVID's food source and made it last longer, in a sense.
Delta comes along and gets around immunity, whether from vaccine or recovery, but a bit less than if you have neither.
Now, if recovery works better at staving off Delta than the vaccine, then places with more initial mild infections are going to do better vs Delta than places with fewer, controlling for vaccination rate.
If we are testing a lot more, we are also going to find a lot more cases, but if transmission is very high of COVID-Classic we should expect to see more variants in the new cases in places that were more open and have fewer vaccinated. Comparing those places to more open but more vaccinated might give us an idea how many stealth COVID-Classic cases there actually were.
Of course, we should also be controlling for how many people come in and out of a country, since they are certainly not closed systems and travelers can transport different subvariants between them.
It is a mess, with lots of causal density and very different outcomes based on which set of plausible assumptions you like, it what I am saying.
You're looking at combination of reopening and vaccination. If you look at the UK data from 2020, cases fall during lockdown and rise after release. Similarly for a lot of other countries.
Actually in the UK 2020 waves, cases began to fall a few days before lockdowns could have had any effect (according to the serial interval being assumed by modellers at the time, at any rate). This got noticed a bunch of times but was ignored, like always.
But I'm not sure going around the lockdown merry-go-round again is a great use of time. UK Freedom Day, Sweden, Florida, Texas, South Dakota, the list of places and events that show lockdowns were having no effect is a lot larger than one, which is all that's actually needed to falsify this theory. To me it is 100% clear and obvious that lockdowns have had zero effect, and it still baffles me that people manage to conclude otherwise. Remember: lockdown theory is total. It has no exceptions. To disprove it all you need is one place and one time where removing a lockdown wasn't followed by an immediate (~few days later) increase in cases, or one time where adding it wasn't followed by an immediate drop. That's it: just one. The rest is gravy.
" To me it is 100% clear and obvious that lockdowns have had zero effect, and it still baffles me that people manage to conclude otherwise."
Am I correct that your assertion is that voluntary behavior changes had an effect but the subsequent official lockdown had no effect? Or is your assertion that both voluntary behaviour changes and official lockdowns had no effect?
The latter. I can see what you're arguing - basically that law changes didn't change how people behave, and thus reality has been a perma-lockdown that therefore cannot be seen in any data except right at the start. But the existence of places where the population took a way more relaxed approach and which had average outcomes, seems to speak against this. Or it jus becomes unfalsifiable and you say, whatever people were doing it was "lockdown" and thus cannot be seen in the data because it never ended or changed in strength.
The Ancient GeekWrites RationalityDoneRight ·1 min ago
"Actually in the UK 2020 waves, cases began to fall a few days before lockdowns could have had any effect,"
What's your idea of the causal mechanism behind that? My idea is that people engage in lockdown like behaviour -- voluntarily staying indoors and masking-- before lockdown orders are issued. Which mean "lockdowns work" is true , inasmuch as it refers to behaviour on the ground.
What alternative mechanism would cause cases to decline just before a lockdown order?
If waves are caused by mutations giving the virus a foothold in a small subset of the population that is vulnerable to whatever the mutation does, then the wave will peak once that small subset has been infected and recovered, restoring herd immunity.
Epidemiological models have no concept of this because they assume 100% of the population is 100% vulnerable to any "novel" virus. If you start asking questions about how they define "novel" and what makes SARS-CoV-2 "novel" and not, say, merely a variant on pre-existing coronaviruses as the name actually implies, then you'll discover there's nothing there. There's no microbiology in epidemiology. They have no way to measure the similarity of viruses so they just assume every virus is maximally new, and every person maximally and identically vulnerable, which is why they are constantly predicting staggering numbers of cases in a single massive wave, and then looking stupid when reality does something very different.
Saying the Taiwan case doesn't count because of a small recent surge is ridiculous. You can just look at the death rates over time and see they were much lower. Despite being one of the first countries exposed
Yes, but how do you know that was caused by contact tracing specifically? The problem is, there can be many different causes for these things. To study the impact of any one intervention, you need to look for some sort of correlation across all countries and the only one anyone can find is vaccines. Taiwan having a surge anyway despite doing the same contact-tracing as before is just one data point.
Most NPIs aren't especially effective, but I don't think that includes contact tracing in a situation where the spread is low enough that it's viable. Multiple countries have done that, but I don't think they're usually included in studies of NPIs precisely because there's so little COVID there (and thus don't seem like useful comparisons for countries that have many spreaders).
"Then they approved a CDC kit which that the CDC could send to places other than their headquarters, but this kit contained a defective component and returned “positive” every time. The defective component was easy to replace, but if you used your own copy like a cowboy then the test wouldn’t be FDA-approved anymore and you could lose your license for administering it."
It's actually worse than that. The CDC developed a three part test. The first two parts looked for two difference parts of the known Covid genome. The third part tried to detect if the virus was mutating. It was this third part that was the really broken one and always said yes. Also some of the tests had a faulty second part. But the first part, which would detect the virus just fine but wouldn't provide information about mutation worked for everybody. In theory hospitals could have just used that first part and gone about their business, that would have been just as good as the tests the South Koreans were using to control the virus. But that wouldn't have been using the kits according to the approved instructions and thus in an unapproved way.
coincidentally, I just had a conversation with coworkers in the hospital today, and when I mentioned that I donated to the most efficient charity according to GiveWell metrics. My coworkers universally denounced the fact that I was trying to do the most good with my money and accused me of paying too much attention to money, also gave me a whole spiel about how it's evil to want more people to live and/or for longer. Like they have no concept of doing good with money. Never before have I felt so alienated from those people. I used to think they were basically decent human beings, now they were just like aliens speaking nonsense. I am so sad.
But like with people like that I can see how this system gets built.
They aren’t not “decent human beings”. Most people have evil, despicable, and truly vile beliefs and actions. And those coexist with the good ones. Given that charity donation is relatively abstract, especially EA stuff is still novel, I don’t think rejecting that is that bad. Kinda hard to understand what issue they’d have with it though (evil? Is this like a conservative “poor people need personal responsibility” thing? How is “paying attention to money” bad?) but that is extremely benign relative to a lot of other stuff
I've noticed that "paying attention to money is bad and you should feel bad" is commonly expressed in my lower-income circles and almost never in higher-income ones, which makes me think it's an internalized form of sour grapes?
Hating the human race seems to have become normalized. While I think that on one level it's just talk, on another level it's the sort of just talk which indicates some sort of a problem.
It sounds like that really affected you. Possibly you've grown used to talking about these ideas with people who are familiar with them and have adopted a certain ethical aesthetic. But it's pretty outside of the norm to view moral decisions in a calculated manner. Before judging your coworkers as evil, I would ask yourself whether you really think they gave the idea a chance before rejecting it, and if they didn't whether that had anything to do with its presentation. It's tough to hammer home the point that money = time = effect, and that the types of suffering that EA targets aren't just abstract years but tangible pain and agony.
Another reason people don't like to consider this argument is that accepting it can lead to a lot of guilt. Once again, it's a matter of presentation to show people it's more an opportunity to do good than a criticism of past actions.
>it's pretty outside of the norm to view moral decisions in a calculated manner
Because once you start measuring moral and practical decisions with the same currency the calculation will cash out very quickly to you being a giant hypocrite. Most people aren't ready and/or willing to deal with the resulting cognitive dissonance, an thus keep those magisteria very very separate.
I don't think that's it. Quite a lot of people think of money as being some grubby capitalist token, which mostly gets used to cheat and steal. It doesn't scan as "resources" to most.
It'd be like looking for cost-effectiveness in a spouse. Merely asking the question would weird out 95% of people.
Well, some of this is probably an innate resistance to Goodharting, which is healthy and rational. It's humanly impossible to make an accurate cost/benefit calculation for the vast majority of complex practical problems, which is something that the EA movement acknowledges, if quietly.
I don't know your co-workers but with the situation you describe, I imagine it is more likely that this was a knee jerk reaction to feeling like you were putting on airs.
I think it is similar to how people respond to veganism a lot of the time, getting very conspicuously upset at other people for being vegan.
I see two different base level objections. First talking about EA and GiveWell might, to them, feel like you are saying "See I am actually a good person, and you are not a good person because you don't give to charity, or give to shit charities that don't do anything", so they get angry and rail against the idea even if they do not actually have any real objections to it. Second they might just object in the abstract to equating human lives with money spent in some squishy monkey morality kind of way without actually grokking the broader conversation. Which is why a seemingly normal person can suddenly be found arguing against saving lives.
Not that there are no real objections to EA(or veganism), I just think that the situation I described would also be common.
Is it just conceivably possible that you mentioned this in such a way that it came across as "Well *you* are all stupider than the dumb beasts of the field, giving your money away to any sob-story, but *I* am Really Smart and have found the Maximum Way To Do Good? Such a shame you can't be like me!"
Because sure, all your co-workers *could* be evil, heartless aliens. Or maybe *you* sounded like a jerk?
It's very easy to come across as holier-than-thou, I've stumbled over that myself once or twice. Phrasing it as 'best value for money' without explaining exactly what is meant by that can sound like 'only caring about money, not the people suffering'.
If I donate to a kidney foundation because my aunt Mabel died of kidney problems, someone lecturing me that really I should be giving all my money instead to mosquito nets does sound like "caring more about money than people". Oh you're telling me to ignore the people I know right here, right now, with this illness in favour of strangers thousand miles away? Where do you get off?
> My coworkers universally denounced the fact that I was trying to do the most good with my money and accused me of paying too much attention to money, also gave me a whole spiel about how it's evil to want more people to live and/or for longer.
I bet that's exactly how they put it, too. While twirling their moustaches and going "mwa ha ha".
No, more likely they told you to focus on charities who address the most pressing problems, or who are based locally, or something -- as opposed to putting your entire faith into one dubious organization's ranking chart. In other words, they said, "consider using heuristics A, B, and C as opposed to just Z", and you went all, "no, Z is the One True Heuristic and everyone who disagrees with it is evil". Who exactly is the alien in this picture ?
I don't know any more than you about the Atlantic in particular, but I will say... every time I've found myself thinking something like this about a journalistic institution or source of information on the Internet, I've ended up concluding with time that the incident wasn't isolated and the bias was pervasive. Listen to your instincts
I don't think it's literally _all_ of their other reporting, or all of reporting in general, but a LOT of it really isn't particularly good in lots of ways. It can be very frustrating reading most 'journalism' or reporting (or anything) once you've noticed this kind of thing often enough!
For subjects or topics NOT subject to strong 'information cascades', i.e. where 'reporters' mostly repeat each other, you can sometimes kind of 'triangulate' based on a number of different published works.
I personally think it's better (tho maybe not by much) to try to read and follow the work of particular individuals that seem relatively well informed (and insightful, and honest).
I also try to _think_ of things I read as 'X happened, as reported by Y, and according to Z' – and to reference those things in the same way. Repeatedly emphasizing, mainly to myself, that these are _claims_, and thus chains or networks of (fuzzy) indirect inferences, helps me remember how weak a lot of what I read is as evidence of anything in particular. Sometimes it seems (to me anyways) like a lot of (roughly) independent weak evidence is, in aggregate, pretty strong evidence of something, but it's generally pretty tricky!
But yeah, Gell-Mann Amnesia is an epistemological nightmare.
As a rule, journalism in any field you know very well, as a professional, will enrage you, so as long as you stay away from articles that talk about any subject on which you are personally an expert, you'll be fine.
I do love any 'inside baseball' from basically any field or topic or whatever tho; they're all uniquely fascinating in the same kind of way (if that makes sense).
I find there's three kinds of writing I see on my area of professional expertise.
1) Dreck. (This is where Gell-Mann amnesia is born)
2) Things written for an audience of actual professionals. (This stuff is really good, as a rule, if you can follow it)
3) Occasional writing aimed at a lay audience, though usually the dorkier end of it, by people who know their beat. Usually the author has professional experience in the field, or at least many decades of writing on the topic. For my field (finance), Matt Levine is the best example I've seen - anyone who knows finance at a r/wallstreetbets level can follow that quite well, but it is clearly written with a deep understanding of the industry, and it shows in how it's written.
The decline of #3 as a journalism school is very sad.
"(T)he long-term solution is to become a different kind of country and different sorts of people"
I know I'm preaching to the choir here, but we will never become that sort of country/people until the people that are start having meaningful interpersonal relationships with the people that aren't.
Brutal twitter owns (assuming that the owner/ownee relationship is not, in fact, inverted) seem to be moving the needle the other direction.
One of the big issues with extremists, on all sides, is that they do not trust people who differ from them too much. They get very suspicious, and assume that everything The Other does is some big conspiracy to screw Our Team over.
Show them that The Other is human, cares about many of the same things Our Team does, and really is trying to make things better, and this state of affairs can be improved somewhat.
Then I'll just ask you for this - quit calling them "lies", and start calling them "confirmation bias". It's more accurate, because most of them were not consciously aiming to deceive.
If you're talking about a handful of people at some agency somewhere, sure, maybe those were lies. (Maybe not - they could well have believed it and thought of themselves as true whistleblowers - but a small group lying is at least plausible).
But the Russian complaints you saw on social media? Those were honest confirmation bias. You can't coordinate that many millions in a lie.
I’m an extremist and I converse with everyone. It’s only made me more extreme.
The nazis were also human and cared deeply and powerfully for their family and brethren and didn’t differ so much from you and me and had the ineffable soul of human development and overcoming. And so do FDA panelists! And so do murder rapists and Monsanto execs and researchers and many sjw woke academics. This does not stop them from doing really bad stuff, and doesn’t stop some of them from needing to be removed from power and discredited.
Talking to people you don’t like is very important, but more so that you can understand them and oppose and develop said ideas, not just to agree with
And yet Daryl Davis has personally convinced a lot of 'extremists' to give up their extremism, and to even publicly disavow it, and the experience of Megan Phelps too, seem to be pretty good evidence that something like 'exposure therapy', where 'extremists' are exposed to their 'enemies' and then change their mind about those enemies being terrible monsters.
I agree that this doesn't actually stop anyone and everyone from "doing really bad stuff" – one reason being that lots of otherwise okay people do 'bad stuff' and another being that there are no perfect arguments capable of convincing anyone of not doing bad stuff (and yet another being that it's not obvious – to everyone – which stuff it is exactly that's bad).
But I'm guessing you're not – or don't think of yourself – as being an 'extremist' in the sense of someone willing to do (or having already done) "really bad stuff".
I fully endorse having detailed and complex conversations with enemies like Daryl does. However, the enemy often wins those. And then you become the enemy. So still do it, but the point is to understand the enemy, and maybe they were right!
I think Daryl's 'won' most of his conversations, and he definitely hasn't "become the enemy" (from his own perspective), tho he's definitely admitted to NOT winning over some of the 'enemy'.
But I really respect that he started it all _because_ he wanted to understand those people.
100% agree with Alsadius. And would also add maybe "have drinks with trump supporter" the wrong place to start/way to think of this.
Because, if my circle of acquaintances is typical of Republican fare, the average Trump *voter* (i.e. voted straight Republican in the last 4 elections and doesn't care who it is as long as it isn't a Democrat) is probably not a Trump *supporter* (i.e. bought the MAGA bumper-sticker/yard-sign/t-shirt discount combo). So maybe instead of trying to befriend the MAGA hat at your local pub, a better action would be to have lunch with your conservative-but-not-all-about-Trump relative/coworker and having a more meaningful conversation that will hopefully eventually have knock-on effects with their even more conservative friends and relations who wouldn't even listen to you.
And I realize that if you don't live in a Red Tribe locale it may seem from a distance that the Republican party is all about Trump, but again if my experience isn't an anomaly then such is not the case.
And I also realize that's a lot of work for at best a very slow payoff. But I can also say with certainty that shame has *failed utterly* as a strategy to combat the problems of today. It has instead auto-catalyzed an oppositional force. Twitter is not going to solve this. Or to put it slightly differently, the Republican party may or may not have been racist before, but as soon as race became a tribe-defining political issue it became inevitable that they will become more so over time.
More people voted for Trump losing effort in the last US election than voted for any winner in US history (including himself in 2016, I'll reiterate: *more* people voted for him in 2020).
There's a lot of them, they aren't going away, and you can't politically defeat them except in a very temporary sense. So that leaves persuasion and compromise.
I propose that college professors be allowed to take whatever drugs they want so long as the drugs won't get them high, and the professors agree to waive medical privacy and fully report the effects of the drugs. This proposal might be politically practical because the left would mostly trust professors to make the right decisions, and the right mostly wouldn't care if professors harmed themselves by taking dangerous drugs.
I suspect if drug approval rules were relaxed to a large extent, along with all the good drugs would come a tidal wave of absolutely terrible ones that’d harm a lot of people. And that the severe regulatory regime correctly suppressed a lot of those second ones right now, so the scale of the problem is not visible, and to understand that one should probably think of medical history pre FDa, while it also wrongly suppresses a bunch of good stuff, which is then visible.
Yeah. Also might need to consider bad medications might decrease use of good medications that treat the same thing. The point is that the harm caused by FDA is more obvious than the harm caused by less FDA because the second is a century removed
> a tidal wave of absolutely terrible ones [drugs] that’d harm a lot of people
Do you mean 'positively' harm, i.e. the 'terrible drugs' would themselves directly cause harm?
As-is, there already seems to be a 'constant (Biblical) flood' of 'terrible health interventions' that harm a lot of people – relative to those people getting or receiving objectively efficacious health interventions.
I'm also skeptical that "medical history pre-FDA", or food safety pre-FDA, was as terrible as you seem to be assuming. I think a lot of the specific motivating examples purporting to demonstrate how terrible medicine or health care, and food safety, were pre-FDA are now thought to be either wholly fabricated or grossly exaggerated. I think it's hard to think of either as being particularly dangerous – relative to all of the other dangers to which people are vulnerable.
And it's not the case that the only two possibilities are 'the FDA exactly as it is now' or 'no FDA at all' (let alone 'exactly as it was before there was an FDA').
Yes I do mean positively harm. Replacement harm by ignoring other treatments is also a concern, but positive harm was what I meant.
> As-is, there already seems to be a 'constant (Biblical) flood' of 'terrible health interventions' that harm a lot of people – relative to those people getting or receiving objectively efficacious health interventions
Is there? There are a lot of bad health interventions, but there are a lot less than good ones. A lot especially are in the category of “contextually do prevent death, but something like diet or environment changing would be better”, but that’s not really a thing the FDA can do much about.
There’s a whole raft of drugs that were claimed by the developing company to be very good and awesome, but the FDA shot down, and then ended up being useless. This is still a problem now, see biased trials from the company and such, but the FDA’s restrictions seem to help restrain that a lot. You can see this with how many late stage drug trials fail, and how many companies really want them not to. If some could just ignore that or twist the data, why not?
In practice without the FDA probably bad stuff would happen and then you’d get a new FDA.
And yeah, obviously the current FDA sucks. Reform good! I’ve seen a lot of actual calls to abolish the FDA though, which seems bad.
It's definitely hard to know how to 'count' health interventions – as individual classes or categories of intervention or per-intervention (and weighted by some kind of severity of the underlying condition attempting to be treated)?
But my understanding is that, even of the "good ones", most health care ('health interventions') probably don't work, beyond perhaps placebo effects. Antibiotics definitely _can_ be extremely efficacious, but how often are they, in practice, given, e.g. being routinely prescribed for not-obviously-serious-and-obviously-bacterial infections?
> In practice without the FDA probably bad stuff would happen and then you’d get a new FDA.
I agree that this is, sadly, true.
> I’ve seen a lot of actual calls to abolish the FDA though, which seems bad.
I'm not so sure it would definitely even be bad, were the FDA to be abolished. I think lots of people are already, now, extremely skeptical of drugs generally, and definitely of pharmaceutical companies. And lots of people (sometimes different people from the previous group, but sometimes the same) are also really enthusiastic about treatments, and even drugs, that either probably don't work or probably would harm them.
And, in my mind, the 'background context' of all of this is knowing that millions of people buy and sell and use drugs that are not only not approved by the FDA, but illegal and for which draconian prohibition is actively and aggressively enforced (however poorly or incompletely).
I'm much more sanguine that (some) people would develop their own (better) alternatives to the FDA were it to be abolished (and drug testing itself wasn't illegal).
Appreciate this summary, Scott; oft thought, ne'er so we'll expressed. Also appreciate the Piers Anthony homage in the title (if I've guessed right) and the fact that you appear to have attracted at least one person formerly shortlisted for FDA head to the comments.
Thank you for the information. Hard to imagine in this day and age the difficulty in finding up to date accurate information. These forums and links have been quite helpful.
I'll give the quick answer here - those are not generally vaccine deaths. Those are deaths that happened after being vaccinated, where someone decided to report it to VAERS (or similar). But when half the population has been vaccinated, the normal background level of deaths is going to be substantial - several thousand people die in the US every day, even at the best of times.
If you look at the actual reports, most of them are either things like "Patient was 95 and terminally ill with cancer", or "I don't see any reason to think this was connected, just reporting it for completeness". https://vaers.hhs.gov/data.html is the raw data for the US, and while it takes a bit of filtering, you can look through it yourself and see if it matches what I just said.
And if you look at what these systems are for, this is 100% expected. The whole point here is to get a big data set and see if things are happening at unusual rates. If a vaccine caused spontaneous human combustion, that's obvious, because that doesn't happen normally. But if it causes, say, a higher rate of heart attacks? Those happen all the time, and you need a big data set to figure out if it's coincidence or an actual side effect. Hence why they ask for a big data set.
You can report "My buddy got hit by a bus walking out of his vaccine appointment" to VAERS. And not even as a joke or a failure mode - if they suddenly get twenty times as many bus accidents as normal from a vaccine, then maybe they need to see about dizziness or judgement issues as side effects. But if there's only one bus hit in the data, that's just a thing that happens. You can't count that one as a vaccine-caused death, any more than it was a death caused by having pancakes for breakfast that morning.
Please don’t expect ivermectin or whatever to actually work for early treatment. A thousand secondhand claims a doesn’t substitute for one solid piece of evidence, and a thousand bad studies can’t stand in for even one good one. Also lmao @ Curcumin (https://blogs.sciencemag.org/pipeline/archives/2017/01/12/curcumin-will-waste-your-time, Well, for one thing, curcumin’s stability and pharmacokinetics are absolutely terrible. It’s less than 1% bioavailable, and its half-life under physiological conditions is measured in minutes. This makes a person wonder how it can be such a wonder drug. The authors of the current paper, indeed, state that “To our knowledge, (it) has never been shown to be conclusively effective in a randomized, placebo-controlled clinical trial for any indication“. )
For your final point, a patent isn't the same as a clinical trial. I believe that's more for the delivery method/cocktail. It shouldn't change your opinion on the effectiveness of either/both of these medications, because the awarding of the patent is not dependent on those. I think this is essentially not a news story, and was just written because it has some hot-button words and can be spun to make the CDC look bad.
With the caveat that prophylactic/early administration was not thoroughly tested, the weight of evidence shows that HCQ is ineffective at changing outcomes for severe COVID patients. Ivermectin is murkier, the data is not strong but there could be something there. I've had a discussion in the past with jstr about this: https://astralcodexten.substack.com/p/open-thread-1745/comments#comment-2128593 there are some good links and commentary on meta-analyses in there.
You have mistaken the nature of the UK report, which does the same thing the VAERS report in the US does, as Alsadius has explained quite well below. On the very first page of the report you linked it says:
"A report of a suspected [adverse event] to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have. Underlying or previously undiagnosed illness unrelated to vaccination can also be factors in such reports. The relative number and nature of reports should therefore not be used to compare the safety of the different vaccines."
That is, in short, just the the CDC VAERS system, they are just keeping track of everyone to whom anything bad happened after being vaccinated, so they can later look into it carefully and pick up anything that is actually related to the vaccine, as opposed to being a coincidence.
Nobody knows yet whether it means something. It certainly means the vaccines aren't an utter disaster, worse than the disease they prevent, because if they *were* you would have more than a milion or more deaths reported to the VAERS system already, plus one assumes anywhere from 5-30 million additional very serious but not life-ending consequences, and it would be an enormous, gigantic, awful and obvious disaster.
The Phase III trial established odds of bad side effects that are lower than 1 in 20,000 or so, because they monitored about 20,000 people very closely for side effects and saw nothing of consequence. But that does *not* mean that the odds are zero. Odds of anything evil that were rarer than 1 in 20,000 would not be picked up by the Phase III trial, unless they were lucky.
Hence the VAERS system. It allows for the collection of data after the vaccine is deployed, so that people have data they can dig into later to discover problems that might be down at the 1 in 200,000 or 1 in a million level, and so which only turn up when you hand out 350 million doses, which the US has done so far.
*Is* there something down around the the 1 in a million probability level? And if so, how bad is it? These are questions that no one is in a position to know, right now. The data from the VAERS system (and its UK and EU equivalents) is just raw data right now, just writing down the numbers, "so-and-so was vaccinated June 5 and such-and-such bad thing happened on June 30." It will take years of careful study for people to dig into that data and try to separate out any genuine connection between bad events and the vaccine from the forest of random bad stuff, and bad stuff that happens for reasons other than vaccines, that happens every day to people.
It's a bummer we have to decide whether to take a vaccine not knowing whether it's got a 1 in a million chance of giving us brain cancer or something, but that's medicine, or life for that matter. There are no guarantees, you can only play the odds. The point of the VAERS system is for the future to be better informed, just as we are better informed because of the chances our grandparents took. (In the earlier days of the polio vaccine, early manufacturing challenges led to quite a number of vaccine-induced polio cases, and some deaths. From those unfortunate events, we learned better manufacturing and better protocols, from which the present generation benefits.)
Yes, I mentioned this below as being wholly unsurprising. There were way more vaccines given this year in the US than in any recent year, so not surprisingly the number of deaths that occurred after a vaccine was given is way higher.
Imagine we had a system that recorded deaths occuring within a week of when people were wished "Happy Birthday!" and for some weird reason in 2021 the law mandated that everyone wish "Happy Birthday!" to everyone they met once a day. The system would be flooded with records of deaths following birthday wishes, but of course on investigation that would turn out to be complete coincidence. Whether the same is true or not for the vaccines we don't know yet (although it is quite likely a priori).
When I saw "we" decide I don't necessarily mean "we as individuals," it includes the possibility of "we as a collective," meaning we elect governors, legislators, and a President, and based on the nature of who we elect they pass laws and issue decrees and otherwise make collective decisions in our names. That's how a democratic republic works, for better or worse. Not *all* decisions are left to the individual, and traditionally decisions affecting public health in the area of communicable disease are one of the few categories in which we traditionally accept that individuals often *don't* get to decide, e.g. if you get TB and decline to take your meds exactly as a physician prescribes, you can in most states be locked up until you do.
Although I have a strong libertarian bent, I'm OK with this, for the same reason I'm OK with the government requiring you not to drive with a BAC above 0.08, and locking you up if you refuse, *whether or not* you individually decide (even correctly!) that you personally can handle it. My ideals of liberty stop short when the free decisions of others pose risks to me and my family that are too difficult for me to defend against on my own, and communicable disease definitely falls into that category.
I might feel differently if I thought vaccines posed significant risks, comparable to the diseases concerned, but I don't. I also might feel differently if I thought reasonable men could conclude, after a sincere and careful examination of the evidence, that vaccines pose significant risks. But I don't.
Why have the reports? So that if the vaccine for Placeholder's Syndrome causes heart attack rates to jump by 50%, you have the statistical power to notice it. That's a fairly big effect in the grand scheme of things, which would cause a lot of deaths in this hypothetical. But no individual heart attack would raise any eyebrows. They happen all the time to people. You would need thousands of reports to be able to say "Hey, wait a minute..." with any degree of confidence. So you ask people for thousands of reports, and then you do stats on those reports.
99.9% of the time it's nothing - all those people who got the Placeholder's Syndrome vaccine and then developed cancer, or Alzheimer's, or diabetes, or high blood pressure? They actually were coincidental (in this hypothetical). But you have to ask about all of them, because you don't know in advance which of them the actual issue will be (if it's any of them at all). You need a big enough data set to find out. Even if all you eventually find out is "Yeah, this is just the normal background rate for gangrene. Sucks to be you, but I see no reason to think it's connected."
The clinical trials are designed to be large enough to rule out side effects that are worse than the disease itself. That's why for COVID vaccines they were quite large (e.g. 60,000 people), while for something like a new cancer therapy for people with metastatic disease, they can be much smaller (a few thousand people): if you're trying to stop death in a patient who's two inches from it, you don't need to rule out evil side effects at nearly the same level of confidence as if you're vaccinating perfectly healthy 16-year-olds against a disease that has a 0.02% chance of killing them.
That gives the FDA enough data to approve the drug, but only barely. They don't do bigger or longer trials than barely sufficient because they're incredibly expensive already, and account for much of the enormous cost to bring a drug (or vaccine) to market that causes the outrageous prices of approved drugs on patent.
But the existence of the VAERS (and other post-approval data collection efforts) allows people to go back later and dig into the data when the drug/vaccine is given more widely, to refine our understanding of side-effects (and effectiveness for that matter). That can lead the FDA to modify its approval, in principle even revoke it, or add "black box" warnings, require additions to the prescribing recommendations, et cetera. It can allow manufacturers to update guidance to physicians in useful ways ("avoid giving this drug if the patient has Weird Condition X or is in Demographic Category Y").
I wouldn't attach much meaning to the fact that there are more deaths reported to VAERS this year than in other years. Recall a death is reportable if it happens after a vaccine is given, full stop. There need not be any causal relationship at all between the vaccine and the death, and presumably in most (if not nearly all) cases, there isn't.
But since *way* more vaccines have been given this year in the US than in any ordinary year, like hundreds of millions more, then obviously a much larger number of deaths become reportable to VAERS, in the sense that necessarily a lot more deaths happened after a vaccine was given, simply because a lot more vaccines were given.
Clinical trials for these vaccines were about 20,000 people. The real-world deployment is in the hundreds of millions. If one in a couple thousand people gets a heart attack from it, you can miss that simply by random chance in a trial. You will not miss it in a group of hundreds of millions, if you have a VAERS-like system.
(And no, the solution isn't bigger trials. Bigger trials mean giving less-tested drugs to more people, which has its own risks, even before you deal with the cost issues).
As for why there's more reports, perhaps it's because most previous vaccinations were aimed at kids. When you vaccinate a bunch of pensioners, the background death rate is a whole lot higher. We're also (plausibly) giving more people vaccines this year than we have in the past 30 years combined. Also, we're thinking way more about vaccines and VAERS as a society than we ever did in the last 30 years.
Weird to write a whole article about this without taking a look at how other first-world countries manage this, to see if they're doing better/worse than the US and why.
It was a pretty substantial article as it is. However, I do keep hearing about the EU permitting useful things which aren't allowed in the US.
I'd heard that the EU permitted bandages with clotting powder for surgery while the FDA didn't. The bandages seems to be available in the US now-- they're even over the counter.
They also approved the first beta blockers about a decade before the US, there's the better sunscreen, better anti-nausea drugs, and the dozen competing epi-pen equivalents that keep prices there down.
I think they're broadly similar and, while they do get some things right that the FDA gets wrong, the reverse is also true.
My favorite tidbit hinting at how crazy all of this probably really is is the huge differences in the RDAs (recommended dietary allowances) for various vitamins and minerals are.
I think this analysis misses the primary point of FDA caution: Thalidomide.
AFAIK, thalidomide is why the FDA expanded out of food. The horrific birth defects arising from Thalidomide use are extraordinarily costly and the impact was small only because it was prescribed for a small subset of pregnant women.
The fear has always been that some other widely used drug will have comparable negative effects - you know, like those spanking new mRNA vaccines.
If they do prove to cause some sort of nasty long term damage, then administering said mRNA vaccines to literally hundreds of millions to billions of people would net a ginormous problem.
I would note from this perspective: aducanumab is relatively low risk from a health perspective.
If it doesn't do anything, it only hurts pocketbooks.
If it causes brain cancer, the dementia patients it is prescribed to are not losing a lot of life expectancy nor are the births of the next generations affected (they're already born).
The 'F' in FDA is for "Food". The 'D' is for "Drug". There was no "expanded out", they regulated drugs from their founding. It was even in the name of the 1906 Pure Food and Drug Act.
"Prior to discovering thalidomide's teratogenic effects in the early 1960s, the US Food and Drug Administration (FDA) did not place regulations on drug approval or monitoring as it later did."
No, they regulated Drugs just like they regulated Food: they ensured what was being sold was pure rather than adulterated. They did not "expand out of" Food to drugs.
You can argue all you want but the facts are that the FDA did not approve drugs prior to Thalidomide.
"Pure" thalidomide vs. "not pure" thalidomide is a product quality issue, but "approved" vs. "not approved" drugs is an efficacy and safety issue.
You might consider re-reading the article: it doesn't talk about the FDA checking the purity of aducanumab. It talks about whether the FDA's approval process is too slow or not.
Your quote in your previous comment doesn't quite support your claim in this one:
> Prior to discovering thalidomide's teratogenic effects in the early 1960s, the US Food and Drug Administration (FDA) did not place regulations on drug approval or monitoring as it later did.
That might just be claiming that they _changed_ the way they regulated "drug approval or monitoring" (but it is a little ambiguous).
The Wikipedia article on the FDA also seems to contradict your quote and claims:
> President Franklin Delano Roosevelt signed the Federal Food, Drug, and Cosmetic Act into law on June 24, 1938. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove fraudulent intent. Soon after passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of "prescription-only" drugs was securely codified into law by the Durham-Humphrey Amendment in 1951.
That seems to be relatively strong evidence that "thalidomide is why the FDA expanded out of food" isn't particularly accurate, even given your subsequent qualifications.
I definitely think you're right that, in the wake of the findings about the effects of thalidomide (when taken during pregnancy), the FDA regulation of drugs changed dramatically.
I think what you wrote is fair - the question is when did FDA approval actually mean something as opposed to FDA "pre market review" or "safety review".
It is abundantly clear, however, that FDA approval did not exist when the FDA was created nor did "approval" mean anything like it does today when the agency was written into existence in 1938 - regardless of what the name of the agency says.
After all, the SEC is supposed to regulate securities...how's that working out?
"But when the US declared that the coronavirus was a “public health emergency”, the FDA announced that the emergency was so grave that they were banning all coronavirus testing, so that nobody could take advantage of the emergency to peddle shoddy tests."
To be fair to the FDA when the bargain supermarket chain Lidl starting selling Covid test kits here in Ireland in May, our public health authority was telling people they were useless and not to buy them, and there was a sharp exchange of views on Twitter between duelling experts:
They give quick results. They are cheap. And they are relatively easy to use. But the arrival of rapid antigen tests on supermarket shelves last Friday has not been without controversy.
Lidl stores are selling their Covid-19 test kits at €24.99 for a box of five. NPHET has cautioned consumers not to use them, with Chief Medical Officer Dr Tony Holohan noting that he is very concerned that they will "falsely reassure people".
NPHET's Prof Philip Nolan, meanwhile, traded barbs on Twitter with Harvard epidemiologist Prof Michael Mina, saying his "snake oil" comments "further sows confusion".
Prof. Nolan on the Lidl ad for the kits: "Can I get some snake oil with that? It makes for a great salad dressing with a pinch of salt and something acerbic. Stay safe when socialising outdoors over the next few weeks. Small numbers, distance, masks. These antigen tests will not keep you safe."
Prof. Mina to Prof. Nolan: "For an advisor to your government - you don’t appear to know what you are talking about @President_MU wrt rapid tests.
The comment adds nothing of benefit and further sows confusion.
Aducanumab also has nasty side effects, including brain swelling and brain bleeds in 30% of patients. Those should be a factor to consider when weighing the cost-benefit calculations of the drug as well.
"This policy has led to our current situation, where either everyone has to be miserable because of stupid people’s choices (eg everyone has to wear masks forever because a few people won’t get vaccinated) or we get a strong anti-freedom lobby because allowing anyone any freedom means that the rest of us have to suffer for their stupid choices."
I am not so sure I follow your point here. It strikes me that "everyone has to be masked because some people won't get vaccinated" is a by product of really bad risk analysis and systemic knowledge, not so much the FDA's own doing. The FDA is guilty of that same bad analysis, but not because they scared people away from the vaccine, I mean. It seems to me that the real mistake was over promising on the vaccine in general on a few margins.
1: The vaccine was never likely to eliminate COVID. We have eliminated exactly 1 disease in the wild, smallpox; everything else still pops up from time to time. Worse, coronaviruses are notoriously hard to vax against because they mutate all the damned time. Claiming otherwise was a really bad move by the FDA/government/doctors/media/whomever got it into people's heads that we could possibly eliminate the disease like it never existed.
If you think that we could eliminate the disease, how many humans all over the Earth do you think we need to vaccinate before we wipe it out? 5 billion? 6? All 7+ billion? I would put forth that it must be a very high percentage given that COVID spreads easily and hides out in people for a bit, and given then the vaccine behavior below...
2: Overpromising effectiveness of the vaccine. Does the vaccine keep you from getting COVID, or just keep you from getting sick if you get the virus? If you get COVID after being vaccinated, does the vaccine prevent you spreading COVID? I honestly can't tell what the CDC or other public health groups think the answer is here.
If the vax keeps you from contracting the disease at all, that is, you get some virus and it gets destroyed before it infects cells or spreads, you don't need a mask at all. (Unless just breathing in some virus from person B then breathing it back out to infect some person C is possible, but then unless you were holding your breath for a while, C could just get it direct from B.)
If the vaccine keeps you from getting sick but allows you to still be a host/carrier of the virus so you can transmit to others, then the vaccine isn't going to stop anything spreading. It might slow down spreading somewhat, but so long as vaccinated people can host there will always be some vectors for transmission. At that point you are just hoping the spread drops below 1 such that eventually the disease just dwindles. Maybe masks make sense in this context if you have been vaccinated, but there is no logical stopping point to that; you are just going to wear masks forever because anyone might be a stealth host until at some point in the future there are effectively zero cases. (Which will never happen if variants pop up that get around your immunity.) Then again, in this case, if you are vaccinated you have no personal risk, so people who are unvaccinated don't exert any externalities on you. So, why wear a mask? Just let those who chose to be unvaxed pay their price. Those who can't be vaxed will need to take tons of precautions in any case, because you can still spread to them, so there is no difference there.
Or... maybe the vaccine doesn't protect 100%, doesn't stop transmission, and won't wipe out the virus, which will mutate anyway. So we are back to the human norm of having one more minor contagious disease that kills us periodically but can be treated pretty well, and more possibly even largely avoided by getting a shot, possibly yearly. In which case, wearing a mask all the time only makes sense if you are a germaphobe or otherwise around people you expect to be contagiously sick, like doctors.
Anyway, yea, I am not sure I get your argument there. The problem to me seems to stem less from people not trusting the FDA, which they shouldn't, and a lot more from people having a really bad underlying model of reality, one in which people never die unless some monster kills them, and said monsters can be eliminated if only the bad people who allow the monster to keep living could be made to stop doing that. This as opposed to the model where nature is constantly trying to kill us, and we are mostly pretty good at avoiding that, but we are not going to ever get it to stop completely. We just knock the sharp edges off the worst bits and try to sand down the rest while doing the best we can with the time we have.
I'm not going to go through your post point by point but the overall impression is that you are attributing statements to the FDA, CDC etc. that are actually the result of bad reporting. Throughout this entire process we've had variations on this theme:
Scientific report says, "In the extraordinarily unlikely case where no behavioral changes occur we would expect 4 million dead." The headlines scream, "Scientists expect 4 million dead!" And people who just read the media reports rather than the original source say, "These scientists are full of it."
I am trying to understand Scott's line about being masked forever because some people are not vaccinated. I am assuming that it is based on sort of the folk theory of how things are working regarding vaccines, masks, etc. If you read carefully, I don't attribute any particular thing to the FDA or CDC, but rather said that people in general (including the FDA) seem to have a bad mental model of the world, and someone put it there.
Now, I did say there were over promises made about the vaccine, and that I don't know what the CDC/FDA/public health orgs in general think the answers are there. Their recommendations have not been terribly clear to me on those points.
So... what statements am I attributing to the FDA, CDC, etc.?
Specifically item #2. Are you referring to the information released by the FDA, Pfizer, etc. or are you referring to news media reports that attempted to summarize that information?
I'm certain that the Barnard English majors who went into journalism are doing their very best to report on the data coming out of the FDA. But that their skillset means that a lot of the scientific and statistical nuances escape them - the put it mildly.
"Or... maybe the vaccine doesn't protect 100%, doesn't stop transmission, and won't wipe out the virus, which will mutate anyway. So we are back to the human norm of having one more minor contagious disease that kills us periodically but can be treated pretty well, and more possibly even largely avoided by getting a shot, possibly yearly. In which case, wearing a mask all the time only makes sense if you are a germaphobe or otherwise around people you expect to be contagiously sick, like doctors."
So, why does the phenomenon of some people not getting vaccinated lead to everyone wearing masks forever again, which is what all this was asking about in the first place?
I would expect the CDC to recommend anything at all to reduce transmission, no matter how low its effectiveness, because they aren't doing political cost-benefit analysis. How could they? They're epidemiologists, Poindexters in lab coats. They have zero understanding of social forces or politics, which is why they got a PhD in biology in the first place.
So they're not in any position to say "well...if we recommend mask mandates for all it would be a tremendous political struggle, and x% of the target audience will flip us the bird anyway because of the absurdly low return of vaccinated people wearing masks, so it's just not worth the damage to the social contract -- let it go (or do something else)." Those are political and sociological decisions, and we elect politicians to make them.
Why would *politicians* preach mask mandates for all because of the (very small) risk of vaccinated individuals passing the bug along? There are two political reasons I can easily imagine for the current Administration (and those of certain states, like California):
(1) To try to recruit the vaccinated into pressuring the unvaccinated. 'Would you go get the God-damned jab so I can stop wearing this silly mask?' That doesn't seem super plausible, because it's childish and it's hard to see anyone of sophistication believing it will work, but politicians *are* sometimes childish.
(2) Because a squalid little secret is that the majority of unvaccinated are *not* fiery libertarians or Trump fanbois. I mean, some of them are, but not most, because there really aren't enough of those people. The bulk of the unvaccinated are poor, poorly educated, and minority people -- i.e. major Democratic constituencies. It would be a very delicate thing for Democratic politicians to pull off saying 'Hey all you poor/low-education/minority people, it's *your* fault this pandemic isn't over, go get your vaccine!' or 'Only YOU fools need to wear a mask, all the people who got vaccinated don't.' So instead they roll it all up into a big "we" as in "we ALL need to wear a mask/get vaccinated because this thing isn't over yet."
That fact that (2) is a political decision, and from some points of view can seem pretty cynical, doesn't mean it's *wrong*. If the goal is maximum public health as soon as possible, it may work better to "recruit" the slackers by the rest of us acting as if we're in it too, like it's a truly all-for-one, one-for-all effort. Enhancing division by pointing fingers at people who already have some general reason to suspect they're treated with extra contempt by everyone else could backfire badly, and make the overall situation worse.
Or not. I'm just speculating. If I understood how to make good political leadership decisions, I'd've run for Congress instead of getting a PhD and being a Poindexter myself.
For some reason, the idea of allowing FDA to grade its approval with stars seems to be dangerous. If the FDA grades a medicine 4 stars, and it causes cancer in a whole city, it can honestly just get away with saying "well we never completely approved it. We just gave it four stars". There's definitely some upside to FDA approvals being binary instead of being graded.
Of course, like Scott said, we have to do a cost benefit analysis, and we might even conclude that in the overall picture, having this graded star system is more beneficial than allowing FDA to drag its feet on things like the coronavirus vaccine. However, it will still be important to hold to FDA accountable for its ratings. Its four star drugs should not be as dangerous as one star drugs (it should have at least an 80% success rate and only a 20% incidence of serious side effects or something like that).
I do think that prediction markets will solve this problem nicely, as noted by another commenter. Worried about taking a four star FDA drug? Well Kalshi says that there's a ~0 chance that this drug is harmful, and this prediction is probably informed by decentralized expert opinion. Hence, it's probably fine.
"Patients will have to choose which insurance to get"
That's not how insurance works in the US as you know...
You also seem to totally discount the existence of bad actors knowingly attempting to get dangerous drugs they know don't work approved. That's where you argument really breaks down.
How, exactly? Suppose those actors manage to push through their snake oil at two stars, where regular doctors still can't prescribe it, what catastrophe would this cause?
My point relates to the larger question of the FDA being a lot more liberal in its drug approval process. Any such proposal needs to acknowledge the existence of bad actors.
The system that Scott described doesn't seem to be obviously vulnerable to them, and it's uncharitable of you to assume that he didn't consider this at all.
What could obviously go wrong? Well the prescribing experts could be defrauded by an unscrupulous drug developer into giving thousands of people dangerous drugs that don't work.
There were terrible abuses prior to the mid twentieth century, like the radium potion that makes your jaw fall off. And that's the motivation for setting up these agencies. I wonder if that stuff is still in folk memory?
The other issue is what do we mean by bad actors. There are people who are knowingly and with malice creating a dangerous product they know doesn't work. And then there are people who set out to create a wonderful new product and staked their fortunes and reputations on it and when the data started coming in the convinced themselves that it really was safe and effective when it clearly wasn't.
Yeah, I'm sure Biogen's executives aren't sitting around twirling their moustaches and cackling, they probably think they're producing a new therapy that has been proven to work on amyloid plaques, and that might help with Alzheimer's if you give any credence to the plaque hypothesis, and it's a terrible illness so what harm can it do and it might help?
And since it's really expensive to do the research and get the approval, they need to set the $50,000 price tag.
I thought this approval might boost the share price, but while it seems to have pushed it up a little, some people are selling their stock since they think the controversy around Aduhelm will damage Biogen:
"The largest factor in my decision to sell is that I lost faith in Biogen as a result of how it is handling the Aduhelm approval on several fronts. The most important of these is regarding Aduhelm's efficacy.
...In summary, Aduhelm does something, but whatever it does isn't enough to reduce Alzheimer's symptoms, and it's unclear whether it can slow or halt the disease's progression. It's hard to believe that there could be a vibrant market for a drug that doesn't actually help people.
Despite knowing all of the above, Biogen decided to move forward with the approval process, thereby exposing its investors to additional risk. Per regulators, the company now has nine years to perform additional clinical trials to find evidence supporting the drug's benefits. If that future evidence solidifies the idea that Aduhelm's benefits are largely theoretical for patients, it'll lead to vastly less revenue and significant losses for shareholders.
Early pricing and revenue stumbles may just be the start
Then there's the issue of the drug's anticipated $56,000 annual cost. That's a huge price tag for something that hasn't been proven to work, and it'll be a hard sell to get Medicare and private insurance to cover it. And numerous healthcare systems, including the prestigious Cleveland Clinic, have opted to refrain from administering the drug until reviewing the existing data themselves. Sales will be slower to ramp up as a result.
Management is defending its decision to move ahead with Aduhelm by painting public criticism as being rooted in misinformation about everything from clinical trial design to regulatory matters and efficacy data analysis. And it says that the launch price of the drug was calculated "based on our belief in the impact of treatment," which, in view of the data about Aduhelm's impact on patients, inspires zero confidence. Furthermore, management actually has had nothing to say about the most important problem: Aduhelm doesn't appear to lead to clinically meaningful improvements for patients.
Still, it's true that Biogen has other Alzheimer's drugs in its pipeline, and other sources of revenue. But given the precedent it set with Aduhelm, it's difficult to be confident in the company's judgment about which projects merit moving ahead. And per its second-quarter earnings report, sales of its other approved drugs are faltering, with revenue dropping by 24.6% year over year. So there's a lot riding on Aduhelm, and right now it looks like the drug won't live up to expectations."
So things may get interesting, if people decide to dump their Biogen stock in anticipation of bad results, then somebody swoops in to buy it cheap: a good gamble, should the other drugs work out, or left with egg on your face if Aduhelm pulls everything down?
If the bit here about the second-quarter returns is true, then maybe Biogen did lean on the FDA to approve the drug since they *need* it to sell in order to save their financial bacon?
Not a great impetus for decision, and a poor precedent, if it's the case.
> You also seem to totally discount the existence of bad actors knowingly attempting to get dangerous drugs they know don't work approved.
I'm skeptical that these "bad actors" exist.
Or does that hypothetical group include people that are (grossly) negligent? I admit that that's an omnipresent risk given, e.g. wishful thinking.
But I don't think there are any significant numbers of 'bio-terrorists' deliberately trying to get "dangerous drugs they know don't work approved", or, as you described them in a subsequent comment in this thread [emphasis mine]:
> There are people who are knowingly and _with malice_ creating a dangerous product they know doesn't work.
_Maliciously_ trying to get a drug approved, i.e. to deliberately injure (or kill) people, seems very far-fetched. Are you imagining something like a serial killer that works at a pharmaceutical company?
Did you not see the spam link to the doctor that claims he can cure AIDS and anything else for that matter with herbs in this very thread? That kind of thing is not rare.
I did! But this then is a nearly perfect instance of "One man’s modus ponens is another man’s modus tollens"!
My point is that, given that the FDA currently exists, people still persist in spamming links like the one you mentioned (and that I myself have seen, twice, in this comments on this post).
But I still don't think that, if the people responsible for that spam _would_ actually give anyone anything to ingest claiming that it would treat a serious medical condition, that they would do so out of a desire to actively _harm_ anyone. It seems to be a strictly (vastly) superior strategy to, if you're going to actually give anyone anything at all, to give them something either entirely benign or only minimally 'harmful'.
I think it's far more likely that it's a more pure scam tho than that – they don't intend to actually ship anything to anyone but just to fraudulently charge them for a non-existent product.
Or do you think there are serial killers attempting to kill people by advertising alternative medicine? I've never heard of any – and there are already lots of opportunities for someone to have done so!
I do believe some of these people might be malicious in the sense of intending to harm people _financially_. I'm still skeptical that any of them are trying to harm anyone _physically_ or medically.
I guess I don't know where you're trying to go with this. You seem to be trying to play a game of gotcha with, " would do so out of a desire to actively _harm_ anyone." If you have AIDS and I tell you that the drugs proven to treat it are all a scam and you should take my herbs - what does it matter if the herbs are benign? You're still killing someone.
I thought you were claiming that people not only had a desire to fraudulently sell 'fake medicine' but to actively poison people too.
In the case of AIDS, selling someone herbs would be pretty similar _because_ there are existing alternatives that DO work.
Let's take something else – like Alzheimer's, for which there _are_ no effective treatments currently (AFAIK). I agree that some people would 'maliciously' try to sell Alzheimer's treatments. I _thought_ you were claiming that people would to try to sell, e.g. cyanide, as an Alzheimer's treatment. In other words, beyond just defrauding people, or maybe not even because of that, they'd want to just hurt or kill people as their primary motive.
"I think the current state of the art is something like Isakov, Lo, and Monterhozedjat , which finds that there are a tiny few disease categories where the FDA might be slightly too aggressive, but that overall the FDA is still much too conservative. "
I might have missed something but I think this is a misinterpretation. They say that for severe diseases the FDA is too conservative, but for for more minor ones it's too lax. Since they only ran estimates for the 30 leading causes of premature mortality it shouldn't be surprising that, for most conditions they studied, the FDA is too conservative, because most of those are pretty severe diseases. But I'm not sure you can generalize that to say that there's only a tiny few disease categories where the FDA is too aggressive.
Not quite - because of what you note below - the ratings agencies do not have skin in the game.
There IS an element of moral hazard still, in that the insurance companies have an interest in the insured dying early, that is not present in the home (and auto - The Insurance Institute for Highway Safety is another example of such a plan) insurance industries, in that death is not an insured event the way a housefire is.
Perhaps we should make health insurance companies issue companion life insurance policies?
The other issue is having personal skin in the game. If you’re a VP making $800k and your options are foot down now and get fired or get fired 3-5 years down the road when it blows up, your incentives are to wait.
There's no perfect system. And in fact I see several issues with this one. It's an interesting thought experiment, but with guaranteed issue, a problematic one
That is something I've long been interested in, particularly given the (implicit) option of having competing organizations.
I've long thought the way 'kosher' organizations work – kind of like of competing (private) FDAs – is really interesting, potentially better than the status quo, and in a real sense, a kind of 'formalization' of what people do anyways, e.g. trust specific people and organizations for authoritative advice.
That's not a terrible idea. Especially if there's some skin in the game, so they assume some risk for approvals. One of the biggest issues I see with an agency like the FDA is there's no REAL accounting either way; do well, do poorly, doesn't matter, you get your check.
Skin in the game is key. IIRC S&P and Moody's got out of any MBS liability be claiming their ratings were first amendment protected opinions and thus they couldn't be held liable when all the AAA bonds defaulted.
Are you saying that the FDA decisions during Trump years were not at all affected or decided by Trump Admin.? I understand that this cannot be the case with the Altz. drug., but the question remains.
I doubt any president has much of an impact on the FDA or any other bureaucracy. The FDA is over a century old, has about twenty thousand employees, and since 2016 there have *9* different commissioners at the FDA.
Under what mechanism could a president plausibly have *any* control over this organization?
That is why I mentioned the 9 different commissioners. Exactly what is a commissioner going to change in less than a year? And for everyone that works there, why would they listen to a commissioner that will only be around for another year?
The commissioner probably can't fire anyone with real power at the agency. They might be able to make a few new hires or replacements for things they care about.
They can set mandates or goals for the agency, but what reason does anyone in the agency have for following these mandates or goals? They'll follow if they want to, but if they don't want to they can just drag their feet until the commissioner is gone.
No, but Trump appointed Scott Gottleib as commissioner, a pretty respectable guy similar to the kind of person any other president would have appointed. I don't think it was very affected by the general Trump dysfunction, though I could be wrong.
Let's say instead of $50K, the drug is $75K. BUT the $25K is set aside in a 401K type trust fund that invests in the S&P 500 and creates shares in a company. Let's call it the Bad Luck Corp BLC.
Shares of the BLC will be split 1/2 to the patient, 1/2 to the payer (i.e. insurance company or gov't program). At a certain point in time, let's say 20 years, the funds are relesed to BLC if a patient has the disease or has died from it. If the patient does not have the disease or has died previously from something else (motorcycle accident say), then the funds go to the drug company.
BLC stock then will trade over time and go up if it appears the drug works less well and down if it appears it works better than expected. Both patients and payers will get the benefit of a rising stock if they 'overpaid' for the medicine earlier in their lives. They won't get any benefit if the drug works very well, obviously, but then if that is the case it is a win for patients and the rest of society if this drug (or some future drug) ends up being the mRNA vaccine of Alzheimers. Note that the benefit happens even if the patient themselves does not get Alzheimers. If your father takes the drug, gets a lot of BLC shares, but then dies in the motocycle accident, the BLC shares are part of the estate and can still go up should the drug turn out to be a dud.
Note BLC is tradeable. If you take the drug, get some shares, you can sell those shares whenever you want. You don't have to wait to get Alzheimers. Of course like Gamestop or Bitcoin the stock may trade up and down running off little tidbits of news and fashion.
- When the FDA approves a drug using a surrogate endpoint, it triggers a BLC. The idea of a surrogate endpoint is "We can't wait long enough to see if this drug extends lifespans, lowers heart attacks, or prevents Alzheimers but we can see it does help this metric we think, but don't know, is related to that end point". The FDA would decide how long such an endpoint would be in the future. A company can avoid this by doing the studies to prove the drug works on the underlying endpoint.
- Insurance companies can use the BLC stock prices as a guide to approving drugs or not. When a BLC's stock price starts to go above a certain point, the payer can say "look the market is indicating this drug probably doesn't work so let's have a conversation about how much we'll cover it despite FDA approval".
This is better, IMO, than Scott Alexander's idea about health insurance that doesn't cover this or that expensive drug. How am I supposed to know that I won't benefit from this drug in the future? I'm just guessing and many people will simply revert to price shopping.
I'd like to take this one level of abstraction higher and all government and government related agencies are slow and disfunctional at best. Using proof by induction, with the DMV as our base case and the FDA and Congress being random N and N+1. In my semi-formal analysis all government agencies are awful. But the FDA has probably killed the most natural born citizens, while the DMV just annoys and angers them.
That being said, if we can reform the FDA to stop killing people, lets not stop the reforming at just that agency. The only real way I see that change could happen is if incentives changed to where there is competitive pressure to work at these agencies, rather than our golden ticket type standard right now of going through an insane hiring processes but once you're in you're in.
I'd like to take a minute for speak up for the DMV. I go in, I take a number, I have a look at the display to see how far out I am, I sit for between 10-30 min, playing with my phone or reading a book until my number is about to come up, and then I get taken care of. It could stand to be over the phone or online, but then, I can get some stuff online now, and the rest they want to be able to look at me and make sure I am who I say I am. It's reliable and not that much of a pain in the ass. I don't know how they and the Post Office got to be the watchword for bad government agencies.
Isn't the review stating that it doesn't make a difference in general, but may* for infants with "pre-existing liver disease," which is presumably the population of interest here? (*Evidence is sparse.)
I’m a non expert staring at abstracts on a cell phone, but I’m confused as the studies I read indicated that soybean oil emulsions caused liver disease in a large fraction of preterm infants it was administered to. So you’d expect fish oil formula to not do that if it helped, but the studies don’t find a difference. Again, I know nothing about this, but this seems like decent evidence against the massive importance of fish vs soybean
I really liked this post, thanks for writing it. Have you done/would you do a post that focuses specifically on how costs are distributed in the American healthcare system? I get the sense that, aside from being monstrously high, our prices are unpredictable and make absolutely no sense for someone paying out of pocket, but I'm never sure how to describe it. Your experience as a provider would surely shed some light.
Thought 1. There needs to be some way of saying "well, ok, maybe it has bad effects in twenty years time, we don't know, but on balance please freaking take it" when the alternative is worse.
In fact, there seems to be a lack of follow up (in all countries) of "ok we did some studies and approved it, now if MILLIONS of people take it, do we detect any downsides?" I know that's hard to do. But we probably need to sooner or later.
Thought 2. Plenty of countries have an approval process for medicine, and provide healthcare in the form of insurance companies, and are nowhere near as screwed as America. I highly recommend a national health service, but maybe looking at what countries more in the middle do and doing that would be a good guide. It's surprisingly easy to forget that as an option
The problem with endorsing untested drugs is not just their lack of efficacy. It's not just the potentially crippling side effects (see e.g. thalidomide). It's also the fact that people who take treatments that they believe to be effective usually stop taking other treatments, which actually *are* effective.
Right now, there are hundreds if not thousands of people out there dying of treatable cancer, because their pastor told them that Jesus will exorcise their disease from their bodies, hallelujah. In Russia, and even in some places in the US, the same is happening with COVID: people believe that good old vodka and a few cloves of garlic will cure anything, COVID included. But those are just regular folk beliefs and established religions. If you abolish the FDA, you will grant pharmaceutical companies; dietary supplement providers; and your local street-corner kook full power to market their miracle cures with impunity.
Yes, I understand that allowing every potential drug to hit the market as soon as possible would save lives; but you must look at the whole picture in your calculus, and the whole picture also includes lives lost or ruined -- which (as is the case with thalidomide) sometimes don't become apparent for years afterwards. Yes, obviously the FDA can be made more efficient, and it should be, but abolishing it would be like setting your boat on fire because you don't like the gas mileage. While you're on the boat. In the middle of the ocean.
Are these other places actually other rationalist places, or are they just weirdo ideological libertarian places billing themselves as rationalists? I understand there are some weirdo ideological libertarians here who consider themselves rationalists, but I suggest ignoring them.
Thinking about Aduhelm and the question of whether it actually treats Alzheimers or just treats beta-amyloid plaques.
Is there a possibility that this applies to some drugs that reduce cholesterol? That they reduce cholesterol is likely true, but that there are no studies showing that the reduction of cholesterol via such drugs actually reduces heart disease? Can anyone point me to some good studies? Thanks.
100% Agree. The system is designed to reward risk aversion, and not just the risk to the public of a dangerous drug getting approved. It's also about their personal risk of making a mistake. No one wants to be the bureaucrat who approves the next thalidomide. So more layers of bureaucracy are added, and along with that comes the inevitable mindset that the procedure is the priority. It's hopelessly broken.
On a separate note, I laughed out loud at the picture of the guy fishing on the ice who burns all the medical bills. That was priceless.
No discussion of FDA intransigence would be complete without a look at the life of John Nestor, https://www.theatlantic.com/health/archive/2012/05/medicines-missing-measure/257901/. I’m surprised he hasn’t been mentioned yet. He spent his spare time causing massive traffic jams on DC-area highways by insisting on driving 55 in the left lane. If an author tried to create an obstinate bureaucrat character based on his life, he would be panned for being too on-the-nose.
"At the FDA, he was a friend and supporter of his colleague Frances Kelsey as she exposed the side effects of the dangerous drug thalidomide. Informed by her experience, Nestor’s tenure at the FDA was marked by obstructionism. In a four-year stretch from 1968 to 1972, he approved zero new drugs for use by the public, viewing the risks and uncertainties still too great. As a result, he was moved to a do-nothing job within the administration.
He protested, and was later reinstated and given an apology by the agency. "
I love the idea of unbundling permission-to-prescribe from standard-of-care. But standard-of-care is, in practice, set by the courts, right? If the FDA said, "We approve this for use, but we don't want insurance companies to feel obligated to cover it", would that make any difference?
As is so often the case when confronted with what looks like stupidity, the problem is metaphysics. Humans everywhere construct a dichotomy between the sacred or pure, and the earthly or profane. Humans naturally interpret FDA approval as being like the purification rituals performed by a priesthood. And you can't unbundle holiness. It's the most-basic ontological divide, between the temporal and the transcendent.
What I don't get is why the FDA has any power to tell doctors what they can prescribe--and especially why alleged inefficacy should justify banning a drug's use. The reason for our heavily-regulated system of educating and licensing doctors is to ensure people can trust licensed doctors. We trust them to cut us open and sew us back up, and to keep up with recent research in their field (even though many don't). These things are simple and objective compared to drug approval. The literature on any particular drug's safety is always contradictory, the studies are mostly fatally flawed, the committee doesn't have time to read the literature that took years and hundreds of millions of dollars to produce, and the ultimate decision is often based on the helpful "summary" of some industry flack.
(Also, it's rare even for drugs that fail the safety tests to be as lethal as tobacco, alcohol, or sugar.)
First, I don't see why you'd object to viagra being available OTC. Second, what I wrote has nothing to do with things being OTC. I believe that doctors should be able to prescribe drugs that haven't been approved by the FDA. Probably none of them WOULD, but they should be allowed to.
I agree wholeheartedly. My point, I guess poorly conveyed, was that the doctors are a huge part of the problem, and they have the easiest ability to fix it. but they wont, and theyll continue to keep the cartel on medical treatment in tact
psychiatrists do this cost/benefit every day with patients with less risk/recourse than any politician and still make the same decisions. maybe change should start there first
actually its worse than that, the FDA has approved treatment and insurance would cover on any number of psychiatric conditions but the doctors won’t actually do it. covid wouldnt be any different
BRUTAL: "Although the FDA did kill thousands of people by unnecessarily delaying COVID tests, at least it also killed thousands of people by unnecessarily delaying COVID vaccines."
July 8, 2021: Joint CDC and FDA Statement on Vaccine Boosters | HHS.gov
Americans who have been fully vaccinated do not need a booster shot at this time. FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary.
August 5 2021:FDA Covid-19 Vaccine Booster Plan Could Be Ready Within Weeks…
The Food and Drug Administration expects to have a strategy on Covid-19 vaccine boosters by early September that would lay out when and which vaccinated individuals should get the follow-up shots, according to people familiar with discussions within the agency.
Seems to be a remarkable turnaround. NBC news had to contact each state to get breakthrough data since the CDC no longer reports on breakthrough deaths and infections:
I’m still stuck on facts of global and American drug development: more new (and effective) drugs get invented in the USA than anywhere else. Every proposal to radically change the way the FDA or any other part of the ecosystem represents implicitly a claim of this nature: “I see the greatest production system for drugs the world has ever seen, and I know how to do better.”
In other contexts we know that imposing strict rules and forcing people to play a somewhat arbitrary game is often a spur to creativity, because it enables direct comparison of things. In medicine, those arbitrary rules look horrifying because they are arbitrarily obstructing people’s access to healthcare. But the gamification seems to be working. Tweak the game, sure, but removing a major plank of it seems reckless.
I think you're ultimately correct, that the FDA's mulish nitpickery has some role in the creative process, and only a fool would want to go back to the 19th century heyday of snake oil medicine, in which sensible and workable therapies were drowned out by a flood of P. T. Barnum mockeries. Crap can certainly drive out good, as we see in how spam has nearly killed e-mail communication, and how trolls can ruin a discussion board. Imagine the same world of spam and trolls dominating the world of medicine and therapy, and trying to defend yourself against *that*. Brr.
That said, I think a better argument for the mainspring of American drug development can be made for the massive American market, the willingness and ability of Americans to pay enormous sums of money for the best possible health outcomes, and the large and very successful American university graduate education and research system in biology and chemistry that produces the basic research insights.
Yes, I don't think I have any meaningful counterargument to that - I'm not sure anyone does. The kind of economic analytical power it would take to pick apart those factors goes beyond anything I've ever seen. I feel like Europe, Japan, and now China have money and decent universities and a desire to live. But from what I understand, they can't touch the USA for drug development.
So I'm just left with a feeling, based on personal anecdotal experience, or gut, or whatever you want to call it. My feeling is that of all the factors that limit drug production, scientific rigour is the most difficult to achieve. So any move that feels like it's away from scientific rigour sets off alarm bells. In the long run, pace the horror stories, I can't see how less rigour could possibly bring us more drugs.
Scott's story of the fish oil is striking - just relax FDA regulations, and we could add fish oil! But I don't think it's right. Just relax FDA regulations, and you'll get 20 companies telling you to add snake oil and mongoose oil and oil of olay. If the fish oil company even exists any more, it'll be drowned out by the noise.
Yes, I think that's a good point. I think people tremendously underestimate the stress, cost, and painful mistakes that would be part of dealing with a world in which there was a much lower level of enforcement of rigor in drugs, because we're more than a century removed from that world. That's why I mentioned the idea that the role of spam and trolls in online communication might be similar -- most people are old enough to realize these things have ruined many aspects of the Internet that *seemed* at the time to be a glorious avenue for the spread of knowledge and useful communication. Social parasitism is a thing among our species, unfortunately.
By the way, I don't mean to imply the Europeans don't do first-class drug development work, they do. There just isn't as much money floating around over there, for the most part. Asia is another story: I think the Asians are starting about 25-50 years behind Europe and the US in terms of their development of their biology research efforts. The Chinese in particular feel like they're living in the US of the 1970s and 1980s, when the cool new thing was space travel and computers. They don't seem fully aware of the exploding possibilities in biology.
Hm, maybe they could still retain some sort of overarching cooperation on big issues, like foreign policy and a military and stuff like that that's hard for a smaller country to do alone as effectively. You'd have to watch out so that organization doesn't get too big for its britches and try to force the laws of the individual nations to conform to the mores of the inhabitants of a single small nation who disproportionately administer the cooperation, though.
After reading over it a few more times I now think you really *are* referring to the EU. I suspect you and in the US and to you it looks like countries like Germany and France are small, but to me, a New Zealander, that is a very difficult conceptualisation so I missed it.
What do we do about all the corporations that currently function via the relatively uniform United States law and commercial code and political situation to deliver services and products and stuff to people from west to east coast? Why would seceded Iowa or TX have a good FDA given the current mediocre state of their state bureaucracies? Or if you’re a lefty and not a rightoid like I guessed, why would seceded CA have a better FDA given it’s mediocre stuff? And what about the other guy, are they abandoned to the miseries of their own designs?
But every developed country smaller than the United States already has a better FDA regime than the US does so, um...
Breaking up along state lines would be a pretty bad idea, although still better than the status quo; breaking up along natural geographic and demographic borders would be ideal.
Smaller countries have better governance because the leaders are less insulated from the people they govern, they have more skin in the game and it's harder to get away with shoddy bureaucracy.
On balance I'm a centrist, if the people from both sides aren't both winning then the policy isn't good enough.
Well I personally don't think of China as a developed country and I don't necessarily think those figures disprove my point as the US approvals still cost way more than the others (and the cost is seemingly the main reason for the fish oil based nutrient taking so long to be approved), however these figures are a lot closer than I would have thought which makes me a lot less confident in my original statement.
The lack of early testing really seems like the greatest failure here, but there's also the shamefully poor quality of publicly available information. This is supposed to be the age of big data, but the federal government is such a shit show that we can't even get properly detailed demographics for deaths from covid, let alone infections or hospitalizations. There is no rational excuse for why I don’t have a more detailed risk profile than the “official” (non-standardized) overly broad age ranges and a vague list of comorbidities. This uncertainty makes me skeptical of the whole situation and I have to wonder to what degree mass hysteria is playing a role.
Sure there is. The Federal Government doesn't *generate* the data, it merely collects and stores it, and makes it available. The reason you don't have amazing data on COVID is because the people who would have to generate it -- the front line hospital staff, physicians, RNs, coroners -- are all frantically trying to save the living right in front of them. They don't have that much time to spend after a 12-hour shift of nonstop care to be carefully categorizing and labeling the dead, and filling out some complicated or oversimplified form and sending it up to the Feds for the eventual use of people like you. Bear in mind nobody on the front line is *paid* for doing any of that reporting work, either. They usually do it eventually, and it makes its way slowly to the right place, but it doesn't come fast, and it doesn't come as complete as you might like, because somewhere along the way some (in hindsight) useful demographic information (age, sex, race, location, pre-existing conditions) gets omitted or lost.
If you want to change that, then by all means write your Congressman and suggest that the Feds give out major grants to all the hospitals in the country for paying medical staff to fill out mortality reports in detail, and quickly and completely, and sending them on up to the government. We would probably also need a well-designed and robust IT infrastructure to collect the data much more easily and reliably, too, and (remembering the Obamacare website fiasco) that probably means another major grant to build such a system. All of this sounds like it will cost a nine-digit number of dollars, so you probably need to be prepared to say from which other government spending priority you want the money taken, or how you want your taxes raised to pay for it.
I’d happily support a tax increase for much better medical data and medical data sharing. But it’s definitely more of a structural challenge than a budget one - there’s plenty of data filling and technology already, it’s just not super duper great especially in the aggregation and presentation. I think people are working on it too! In particular the state of it currently is quite bad iirc, hence OWID and stuff being de facto sources when something in the govt “should” have been collecting and presenting it
Sure, I'd support it, too, although I don't think there's any need for a tax increase, as I have no problem pointing to several hundred $billion of Federal spending that I would already cut, and a small fraction of which could be redirected to this useful purpose. One of the few things government can do that is pretty uncontroversially and obviously good from nearly any political viewpoint is to collect good data and make it widely and freely available.
>The Federal Government doesn't *generate* the data, it merely collects and stores it, and makes it available.
But much of the data we need, is data the Federal Government *could* generate, and at relatively little cost. To know, e.g., whether we need to close down elementary schools, we don't need data on every schoolchild in America. It would suffice to pick a dozen or so schools that for whatever reason haven't closed down in spite of local community transmission, collect and analyze detailed data on those students and teachers and their immediate family members. That could be done by parachuting in a few CDC test-and-trace teams, without substantially disrupting local medical personnel.
That could have been done over a year ago. That would have been incredibly valuable data to have had a year ago. And it isn't just the CDC that's to blame for that one, because any of the larger state health services could have done it just as well. But none of them did,
Well, sort of. The Federal Government doesn't actually maintain the staff needed to do such a thing. They usually just hand out grants to *other* people to do research like that, and of course the whole grant-application thing is fraught and takes a long time. I expect plenty of grant applications *were* submitted, and the alphabet agencies have probably already approved a bunch and studies are gearing up as we speak. Sometime in 2025-30 we'll have some answers.
That isn't entirely cynical, either. If we want the government to have crack investigative teams standing by all the time[1] it would cost a bundle, and how often would we use it? Nevertheless, it's a serious question about which we might be well-advised to think.
You are wrong about one crucial fact in your argument: neither public payers nor private insurers have to cover any given therapy. Surely you could have just checked with a drug rep friend? One of the huge headaches for pharma, patients, and physicians is that medications with better efficacy, safety or tolerability often require days of paperwork hurdles or are simply not covered.
There is no requirement that payers cover approved drugs. Period.
In fact, this fact probably results in tens of thousands of deaths. When a patient with fulminant acute leukemia cannot get immediate treatment because the paperwork takes three days, he or she often dies in the interim.
My sister has a glioblastoma. She took one anti-seizure medication which left her so tired she couldn't function. Her insurance company refused to authorize a different medication until she and her doctor stumbled on the magic formula: she had lost her appetite. Crazy.
Your argument falls apart if it is based on that faulty premise.
"By March 1, China was testing millions of people a week, South Korea had tested 65,000 people, and the USA had done a grand total of 459 coronavirus tests. The pandemic in these three countries went pretty much how you would expect based on those numbers."
When I look at China's numbers the only thing I'm pretty sure of is that there's no way they represent reality. Do you have some reason for giving them credence here? Either on the testing front, or on the course of the pandemic?
The public graph of cases over time from China is not consistent with reality, possibility, rationality, or epidemiology. I don't even need to find a specific one to prove my point; they all do.
The depth of China's lies about how they have been impacted by coronavirus swamps any meaning we could hope to draw from their story. When we can't possibly know how bad their situation is, or how many people have caught it, out how many people have died, it is ridiculous to hold them up as an example of what to do right.
I haven’t looked into it very well, and sure they may have fiddled with cases and probably did given they fiddle with literally every other statistic. Nevertheless they appear to have managed it somewhat decently, and are in fact mass testing and continue to because their vaccines don’t work so well, and are doing sporadic lockdowns to control emergence based on those tests, and like the citizens do report being frequently tested, and other East Asian countries have also had success with test and trace and sporadic lockdown, so then testing a lot is believable.
The only half-serious attempt I've seen to look at second order effects and try to predict how badly China was impacted estimated 8 figures of deaths in China within the first half of 2020. Their primary state telecom company reported something like a 15 million subscriber decrease in just Jan-Feb 2020, which was quickly "adjusted" a day or two later.
Do you have evidence to support your opinion that all that occurred with the statistics was "fiddling"?
Go to any aggregator of repute, pull up the case or deaths history from any 6 countries in the world including China, and tell me what reasonable conclusions we can draw about how they're managing it.
"Around 2010, Boston Children’s Hospital found some loophole that let them add fish oil to their nutrient fluid on site, and infants with short bowel syndrome at that one hospital stopped getting liver damage, and the FDA grudgingly agreed to permit it but banned them from distributing their formulation or letting it cross state lines"
So why couldn't all the other hospitals simply apply the same 'loophole'? How difficult was it to figure out the formaulation?
> So when I talk about unbundling FDA approval, I mean that instead of the FDA approving the following bundle of things…
Or you could push for universal healthcare so that what insurance will cover isn't under FDA's purview at all, so you're just left with the 1 responsibility.
So what is and isn't covered is determined by which political party controls Congress? Whether you get a kidney transplant or live in thrice-weekly dialysis for the rest of your life is determined in the same way Congress decides on Amtrak or Post Office subsidies, or whether to pay SpaceX or Boeing to build heavy launch vehicles, with all the associated politicking and lobbying?
You'd think any Republican who lived through the election of 2008, and any Democrat who lived through that of 2016, would shudder in horror at that prospect.
Well, that would be a good argument if I *agreed* every nationalized healthcare program around the world were run effectively and humanely. But I don't.
No doubt are poorly run ones from which to learn. But are they so poorly run that they're worse than >10% of its people literally having *no health care at all*? Are they so poorly run that they lose their health care if they lose their job, even in the midst of a pandemic?
In what First World country do 10% of the people have no health care at all? Certainly it's not true in the United States. Go into any big-city ER, and you will see a flood of people, often 80% or more of the patients, who are receiving first-class medical care for everything from a broken arm to metastatic lung cancer, and who will never pay the bill. It is not legal in any state for a hospital to decline to treat a patient merely because he cannot pay, and so they don't. (This is one reason medical care for those of us who can and do pay is more expensive, of course, we subsidize the healthcare of those who pay nothing.)
Moreover, every state in the Union has an indigent healthcare insurance program. If you're poor enough you can get on Medi-Cal in California, for example, and have a decent (if not luxurious) healthcare plan that covers routine exams, sniffles and infections, major trauma, even kidney transplants. And the net cost in premiums might easily be $0/month, courtesy of the taxpayers.
It's certainly correct that the current US system of employer-mediate healthcare insurance is stupid, but that is a legacy of Democratic tax law policies designed to satisfy their major constituency at the time, labor unions, which negotiated extremely generous healthcare plans as a form of secondary compensation (including post-retirement) but didn't want them taxed as ordinary income. So we have this idiot system where it is far cheaper to buy insurance through your employer than on your own, simply because of the tax law.
But it hardly dooms a person who loses his job to losing his insurance. COBRA allows you to maintain it for a while, although you have to pay the full premium, which is a shock for most people, and there *is* an individual market for healthcare plans, although it's not as good as the employer market. These are giant pains in the ass, and for some unlucky people seriously painful -- but, you know, losing your job necessarily is painful. You often lose your house, too, and your retirement savings, and they can repossess your car and all kinds of nasty stuff. You might find yourself having a hard time paying the heating bill (in winter), or buying enough food. It's not obvious to me why healthcare insurance should be some very special category of thing that joblessness should not touch at all.
> In what First World country do 10% of the people have no health care at all? Certainly it's not true in the United States. Go into any big-city ER, and you will see a flood of people, often 80% or more of the patients, who are receiving first-class medical care for everything from a broken arm to metastatic lung cancer, and who will never pay the bill.
Yes, I'm speaking about the US, and those people in the ER that have no insurance and can't pay are there out of desperation; they don't get healthcare for the vast majority of the ailments they suffer in life except those emergencies for which they simply must risk bankruptcy. Scores of documented examples of this.
> It is not legal in any state for a hospital to decline to treat a patient merely because he cannot pay, and so they don't.
Technically correct for "emergency" conditions, but often incorrect in practice for common healthcare needs, and those patients are also then saddled with absurd and fictious bankruptcy-level bills.
> It's not obvious to me why healthcare insurance should be some very special category of thing that joblessness should not touch at all.
Not being healthy inhibits your very ability to address literally any other concern. This is not the case for being jobless. Losing "stuff" is simply not the same category of problem as losing "health".
I feel like you're bordering on being disingenuous in your descriptions of US healthcare. The inefficiencies and failures are well known. Yes a national healthcare/single payer system will also have failures, but nowhere near as extreme, nowhere near as widespread and nowhere near as costly as what the US currently has in place.
Right now Medicare is forced to cover whatever the FDA approves, so if the universal healthcare was Medicare For All or some equivalent, it would be too.
A thought on the star-system - would it make more sense to split it into two sets of ratings?
One representing "confidence that the drug does the (desired) things it says on the label" (A wording chosen to step around off-label/novel uses), and one representing more or less "confidence that all the side effects are on the list of known side effects with risk factors and incidence rates reflecting reality".
I would prefer this split because the single-set system as proposed (at least as I read it) interacts weirdly with, for example, drugs with likely awful side effects that are less bad than what they treat - for example, in a sense at least, a really good five-star chemo drug is less safe than a two-star sugar pill.
That said, it's possible that by "the drug is safe" you mean "we are very confident we know the side effects and risk factors for them"...
Source for "the only reason we can get these at all is through provisional approvals that they wouldn’t have granted without so much political pressure," please?
Scott's dismal assessment of the FDA's incompetence tracks the narrative told by Michael Lewis, in Premonition. The root cause is obviously the dysfunctional incentivize structure inherent in any political bureaucracy. This follows the entire body of microeconomic theory and empirical research, which uniformly stands for the proposition that bureaucrats following their own interests will **always** get the cost-benefit ratios wrong.
Scott's idea of provisional/scaled "approval" levels seems like a great reform. Another reform that might be useful, however, would be to have an entirely independent and alternative path to go around the FDA when it is dragging its feet unnecessarily. Perhaps this consist of some association or jury of specialists in the particular field that could vote to at least allow certain especially qualified members of their specialty to provisionally prescribe the medicine based on an individualized review of the safety/efficacy data as it exists, as compared to a patient's individual risk/benefit circumstances. (For example, a patient who is about to die without the drug, or a patient who is highly unlikely to have potential side effects). This clinical experience could also be monitored and folded into the overall case for and against the drug.
A guess a question for Scott would be how to get a real reform process started in light of the entrenched incentives? But I guess that is always the big question.
As a side note, the bad reporting of the Atlantic seems typical of how the "prestige press" seems generally incompetent to analyze any issue that involves hard technical and economic issues. They usually just aggregate banal quotes, talk around the issues in verbose prose, and then conclude with how "these are complicated issues," people are "trying hard," and "doing their best," but really smart "experts" are on the case and aware of the issues, so they'll keep all this in mind and hopefully do better going forward, blah, blah, blah.
I really like your idea of a more fine-grained rating system for the FDA but I think your single dimension star-rating system in combining two important dimensions: safety and efficacy. The FDA should separately report safety and effectiveness.
Something that may or may not work but is not dangerous may still be worth taking for many people.
Something that definitely works but is also dangerous could still be worthwhile for a different subset of people.
Drug ratings for pregnant women have a similar problem with their one-dimension rating system. Drugs in class C may be safe but with unknown effectiveness, or they may be effective but dangerous. The difference is important to know.
Great article! It feels a bit like the FDA is robbing me of my life. The government is blocking one of the most important things in life, my health. Why are we allowing govt to force what my doctor and I can and cannot use as treatment? If I’m willing buy a drug from a company that’s willing to produce and sell that drug then it’s in my best interest to work with my doctor to decide what’s best for my life. The FDA would be greatly improved if it’s role was simply to protect citizens from false claims (ie: if a doctor or drug company lies to me in order to get me to use their treatment)
That's actually all they do. They just say "in our opinion this works, and this doesn't." The problem is that as soon as they say "this doesn't work" your insurance company says "oh in that case we won't pay for it" and your physician might say "well hell I'm not going to prescribe it because I don't want you suing me for malpractice."
But it you were rich enough that money was not a big problem, I am pretty sure you could find a physician somewhere who would prescribe anything that wasn't flat-out illegal according to the rule of the state in which you live, and you could pay for it yourself, and then the FDA's opinions, for you, would indeed be merely advisory.
Thanks for the reply! It got me doing more research… the FDA’s own website says “New drugs and certain biologics must be proven safe and effective to FDA’s satisfaction before companies can market them in interstate commerce.” I’m still pretty sure if I created an affordable $5 covid test, I’d still need to be approved by the FDA before selling it to you otherwise I’d be in trouble with the law. I think that’s also what AstralCodex is pointing out in the article.
Book review request: Upton Sinclair's "The Jungle," would be interesting to see what the pre-FDA world looked like (from the perspective of what I can only imagine is the early 20th century equivalent of a quirky rationalist blogger), and whether there's a reason for the madness.
The most important thing about "The Jungle" is that it is a work of dramatic fiction, not reportage. The story seems to have been built the same way Mike Daisey constructed his story on Foxconn working conditions - a reporter briefly visits a location, collects the most disgusting stories anyone he can find there has heard of or invented no matter how outlandish, makes little attempt to confirm anything, adds an additional layer of exaggeration "for dramatic effect"...and pretends to be reporting on real life as personally observed.
Scott, if you haven't seen it yet, Matt Yglesias also wrote an essay on the FDA situation (two weeks ago; not subscription-locked), and I think it complements yours quite well: https://www.slowboring.com/p/fda-cost-benefit
CNN interview of Walensky was removed by google. It is now on rumble:
CDC Director Rochelle Walensky stated the vaccine does not prevent COVID-19 infection, nor does it stop the vaccinated person from transmitting the infection or the delta variant. According to Director Walensky, the only benefit from the vaccine now is presumably that it reduces the severity of symptoms.
I just Tweeted a thread with some overlap to this post, including a rec for a good podcast interview with a former FDA person who argues in favor of the Aduhelm approval and the use of the accelerated approval mechanism of the FDA, plus my comments on why that will be good for the aging/longevity space and in particular that the chance of using an aging clock as a surrogate for approval via the accelerated (conditional) approval + phase IV trial mechanism may be fast approaching as it is likely one of these clocks will outperform Abeta in AD prediction soon. See: https://twitter.com/KarlPfleger/status/1423774160321490950
New coronavirus variants could be named after star constellations once letters of the Greek alphabet are exhausted, a senior World Health Organization official has suggested.
In an interview with the Telegraph Maria Van Kerkhove, the WHO’s technical chief for Covid-19, said the UN health agency was already looking at new names for mutations amid fears there will be more concerning variants than the 24 letters of the Greek alphabet.
Medicine is too complex for a uni-dimensional "star" system. FDA should strive for clarity, not simplicity. State what we know, without messaging spin. Others can do the messaging. Be a source of truth, without taking responsibility for all the knock-on effects. Sharpen the blade; don't dull it in the vain hope of improving system-wide outcomes. That's the only way to develop a stable reputation.
The FDA approved an ineffective drug for Alzheimer's, aducanumab. Scott Alexander has a post on it, including a broader discussion on whether the FDA is too lax or too conservative. The right answers is that it is both; Scott doesn't discuss oncology, where arguably it is too lax, enabling multi-million dollar biotech grifts to exist. Scott's framing is puzzling; why "pulling the FDA level" towards being more lax when one can propose both tactically based on cost-benefit analyses. Anyway, the solutions he discusses later are good and go beyond the FDA: the reason we ultimately care about the FDA approving useless drugs is that the US healthcare system will pay for them. That has to change: The FDA could switch to a multi-tiered level of approvals and Medicare should be decoupled from the FDA so that they don't have to cover all drugs coming out of FDA approval. Here's a critique of some of the points that Scott makes.
Liked the article all except for this blurb that makes it seem like there is absolutely no reason not to get a covid vaccine:
"this policy has led to our current situation, where either everyone has to be miserable because of stupid people’s choices (eg everyone has to wear masks forever because a few people won’t get vaccinated) or we get a strong anti-freedom lobby because allowing anyone any freedom means that the rest of us have to suffer for their stupid choices."
There is a 3rd option - which is to let the vaccinated people be protected, and the unvaccinated people live-out the consequences of their choice. In reality a cost-benefit analysis would tell you that there is almost no benefit to anyone for healthy people under 40 to get vaccinated. For older people and people with other risk factors the vaccine is by far the best thing they can do to protect themselves.
Lesné's work is the basis of all the beta-amyloid work (which this drug is based on) -
A quote - "A 6-month investigation by Science provided strong support for Schrag’s suspicions and raised questions about Lesné’s research. A leading independent image analyst ...reviewed most of Schrag’s findings at Science’s request. They concurred with his overall conclusions, which cast doubt on hundreds of images, including more than 70 in Lesné’s papers. Some look like “shockingly blatant” examples of image tampering, says Donna Wilcock, an Alzheimer’s expert at the University of Kentucky."
Like many things, like doctors, computer security, and safety maintenance, government often fades into the background when it works, while being a blistering sore when it doesn’t. Building codes for safety, road planning and construction to reduce fatalities, food producer and preparation regulation to reduce illness, the entire criminal court system, the EPA (notice the sky in cities is. Not dark grey anymore), commercial law, etc. these all work pretty well! And for the lauded efficiency of corporations - people inside those constantly complain about inefficiency and stupidity as well. I’m not critiquing public choice economics or anything, just pointing out that the government often works okay, even if often it does not, and is certainly not a failure. The “government” has solved thousands of your problems.
Not sure about that! The marginal benefit minus marginal cost of a govt dollar or employee or whatever is different between welfare slash wealth redistribution slash poverty remediation and military spending and fda spending and say irs spending (which needs increasing!). I don’t see at all why “the benefit of government is exceeded by the cost” is true as a whole when we can instead say some parts should be expanded and others contracted much of the larger government is, in fact, good - the EPA is pretty nice, and arguably has too little power (well, in some areas, and not in others). Government size is a terrible metric for what should’ve been actual substantiative reforms. Otherwise you’ll get more IRS cuts (thanks Republicans striking that from the infrastructure bill compromise iirc) and cuts for enforcement of important regulatory codes and no changes in money for poor people cuts which is what you want I believe
The IRS absolutely and definitely needs more funding so they can collect more tax revenue and enforce stuff. https://www.cbpp.org/research/federal-tax/depletion-of-irs-enforcement-is-undermining-the-tax-code and said funding will turn up much more revenue than it costs to fund https://budget.house.gov/publications/report/funding-irs because the irs had its funding markedly reduced to benefit tax evaders and that can be reduced
Even under such a system corporate and rich people still have extremely structurally complicated finances where a lot of the income could be located in different areas and so we will still need tax enforcement. Additionally, finance is complicated and and reforms would surely still be. I’m not opposing tax reform but it’s been tried a lot and the irs would still need funding.
I’m more or less happy that the EPA has moved the goalposts as we’ve found that lots of contaminants that are less obvious are full quite harmful, and suspect that we have much less environmental enforcement in the way of chemical pollution than we need, although we have overreach as well in some areas. I don’t think defunding is the answer, especially if pollutants are still decreasing (and maybe they’ve been replaced by new ones?)
Is there some way to report spam?
From [Publisher Agreement](https://substack.com/pa):
> - Reporting a User: You can flag that a user that is violating our Terms of Use by sending an email to tos@substack.com. After you provide us with written notice of this violation, we will determine whether this user’s access to some or all of your newsletters should be suspended or terminated. We will also decide at our sole discretion whether this user’s access to the rest of Substack will be suspended or terminated.
That seems to indicate that Scott would need to report this user but maybe anyone could do it too.
Seriously? Wow. I thought they were way more professional than that.
Countering spam, and security more generally, is really hard. And anything you make to do that can itself be 'weaponized'.
That said, I think these comments are the first spam I've seen on any 'newsletter' on Substack so far, which might, if anything, demonstrate that they _are_ pretty "professional" in this regard.
I agree that stamping out 100% of spam is hard but the blurb sounds like the website isn't even doing the easy things (e.g. statistical filtering).
I'm less sure as this is the _only_ failure I've witnessed in months. GMail fails – visibly – more often than that for me!
This clinches it, give Dr. Ogu's herbal medications FDA certification right now! 🤣
This is not only spam, but a duplicate post.
It's also on the last Open Thread and the Model City post.
Better scratch Alzheimers off the list of things it cures.
LOL
This is as bad as any FB allowal of known to be fake news.
Do not post ridiculous comments here. Respect people's opinion
I do not automatically respect other “opinions.” This is just advertising. Does not belong here. And us bs.
I think this combination antiviral, antibacterial, antifungal, anticancer, neuroprotecrive, antiparasitic, thrombolytic, anticonvulsant, antihypertensive miracle herbal preparation needs rapid investigation, multiple large trials, breakthrough status, and most of all right for any doctor to prescribe (with informed consent of course) to anyone who needs it.
This is spam and should be deleted.
Oh no! In terms of the need to regulation this is example number 1.
But here we have a patient's testimonial that the natural herbs of Dr. Ogu cure everything from epilepsy to AIDS, what more evidence do you need before licencing it? What are you, some FDA bureaucrat? 🤣
Is there no "report spam" button?
This is almost as bad as the lack of a Like button.
Strict? lax? fast? slow? is not the point. FDA does not use cost benefit analysis in it's approval process. Which would not be bad except that nether do doctors or insurance companies including Medicare.
I think it sort of does, informally, to some degree? This is kind of what some of the fast-tracking programs are - given that this drug is really important, we'll let it through a little faster.
I agree a formal cost-benefit analysis would be better. I genuinely don't know to what degree the FDA does this. And I suspect if you asked them to, it would just be one more six-month-long $100 million piece of paperwork they would have to do before they approved anything.
To the extent that you can get approved for reducing things like hospitalizations it uses cost benefit and they talk about risk benefit a lot but they are garbage at the latter. I don't think price should go into the FDAs decision at all. But insurers need to prioritize cost benefit and make that the core of their decision making. The FDA should really say is it safe? If so allow people to take it/prescribe it. Is it effective? If so allow drug company to advertise it.
There should be room for things that are safe but we don't know much else and people can roll the dice and pay out of pocket for that or choose an expensive insurer who'll cover anything. That's basically how we treat supplements. FDA is like airborne won't kill you but we aren't saying anything else.
The FDA is forbidden from considering price during the approval process. They don't exactly say this in https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/frequently-asked-questions-about-cder#16 but they strongly hint at the fact that price doesn't enter into the evaluation.
That said, individuals at the FDA have their own opinions about drug pricing, and if they think something is just a copycat of another drug with a 100x mark up, that can have an influence on the approval process, largely through making more demands on the approval seeker.
That could be a problem. Probably the right way to put this is that the procedures should be designed on cost-benefit grounds. Whether a full cost benefit analysis of each decision would be cost effective or not is uncertain.
NICE in the UK might be an interesting counter example as they explicitly take cost into account. But I've no idea how that works in practice
NICE is a great example to look at. The QALY based approach is much better than how it's done in the US. (Note, the "death panel" rhetoric seemed to be effective when this sort of thing was last contemplated during the ACA negotiations).
I have a sneaking suspicion that if you allowed insurance companies to deny treatments that are FDA approved, what would stop them from just denying ~all treatments? Maybe the argument would be "in a free market who would buy that insurance", but I think the "FDA approved treatments must be covered by insurance" rule might currently be keystone of the existing regulatory structure and so couldn't be removed without other changes.
I think you'd need to switch to something like single payer to be able to decouple the FDA from insurance approvals. Sketching out a way for this to happen:
1) Medicare for all
2) Medicare is allowed to negotiate drug prices
3) Medicare uses a QALY-based system to decide which treatments it will approve
I'd like to use an insurance company that says "we will approve anything that costs no more than $X per QALY."
It would take a while to figure out how to actually run the formula: you can add more variables to the function to change the output, but using NICE as a model would work for a first pass.
A common challenge is a lack of good evidence. In light of that, who would you trust to pick the priors?
For example, NICE says (https://www.nice.org.uk/guidance/ta1/chapter/appendix-c-wisdom-teeth-removal-patient-notes#appendix-c-wisdom-teeth-removal-patient-notes) "Impacted wisdom teeth that are free from disease (healthy) should not be operated on."
Imagine that your dentist is telling you that in a short but unknown number of years, you will have to go through _large number here_ units of pain and suffering if you don't get them extracted now.
What would you like the insurance company to do? If your response is that the patient or dentist could appeal, then you've reinvented the American healthcare system, complete with prior authorizations.
I think your post points out that they do cost/benefit - but they are weighing the wrong cost (how likely am *I* to be blamed if something went wrong) much too highly.
My read here is that the FDA is structurally hard-wired for making decisions in a regime where the cost/benefit margin is very narrow, for example where there are already drugs treating the condition and you're just trying to show that you're better than the current best option. In these cases having a long and rigorous process where "default to no action" seems at least defensible. "First do no harm" etc.
So perhaps you could say there's an informal cost/benefit, but I'd argue that it's at best accidental -- and I'm not even sure that this is the right way of framing it, because I really do think that regulators are explicitly opposed to the cost/benefit lens. Certainly, many public health figures recoil in horror when you suggest that this logic should be applied to the problem. Remember when the German regulators said "we know that the risks of Covid are higher than the risks of blood clots, but we must pause the vaccinations because the rules say that all side-effects must be listed on the drug". I think the FDA considers things similarly.
My impression is that the Thalidomide crisis is pretty deeply carved into the FDA's organizational DNA; they still have this historical memory of the time that the EU regulators approved Thalidomide, and the FDA heroically applied skepticism and correctly averted a crisis.
I think a more explicit cost/benefit framework is the solution for the "too strict/not strict enough" mis-calibration you observe. It seems uncontroversial (or at least inconsequential) for the FDA to err on the side of being conservative on approvals for mostly cosmetic treatments (e.g. breast implants) or cases where we already have treatments (e.g. the next anti-depressant), but there's clearly a highly broken process when you look at the cases where inaction actually costs lives; for example, the fact that at the time of the AZ blood clot panic the US was sitting on something like 50m AZ shots that were not approved, despite them obviously working if you looked at the UK data. Deploying these vaccines could plausibly have saved thousands of lives, if we'd got to vaccine saturation 3 months earlier. Similarly, the pause on J&J (though I'm not certain if that was led by FDA concerns).
Having said all this -- based on the current discourse, I don't think the public would be on board with a cost/benefit analysis approach.
There is nothing about the Thalidomide case that implies that it would have been applied if FDA had been applying a cost benefit approach.
My point with Thalidomide is just that it gives us a possible explanation for why the FDA might be overly conservative. It's both a lens to understand their existing organizational psychology, and also to test/craft the messaging on any possible solution.
For example, with a cost/benefit approach, if you re-analyze the Thalidomide approval process with a proposed new framework and get the result "this drug is for morning sickness, the absolute benefit is quite small, so we should be extremely conservative", then I think you could persuade FDA people that you're not just opening the floodgates on a wild-west of drug approvals. And (I suspect) if you use Thalidomide as a case study that works well, you might win over more of the establishment.
On the other hand if the new proposal is just "approve any drug that has been approved in the EU", while I personally think that would actually work out as a net positive, it's probably not going to be a popular position with the FDA as it fails the Thalidomide test. Or similarly if you just propose blanket loosening of standards.
I would think that in a cost benefit approach information from trials run in other countries would have some weight in the outcome. So totally excluding information from those trials would be inconsistent with cost benefit analysis. On the other hand, cost benefit analysis is both more and less than "approve anything approved by certain previously vetted foreign regulatory agencies."
Thalidomide is a great example of the bankruptcy of the FDA's legitimating arguments. It was rejected in the U.S. based on the old safety standard--does it have dangerous side effects?--but that wax used to leverage a completely different efficacy-testing standard that has essentially no bearing on why Thalidomide was blocked in the U.S. (Added irony that of course it is now a useful drug in number of areas.)
The rule suggested by Thalidomide is "automatically approve any drug approved in the EU but only do so *after* a short bureaucratic delay - say 2-5 years - to allow us to notice if the new drug produced any blatantly obvious negative effects on the Europeans who started taking it first."
Re. "In these cases having a long and rigorous process where "default to no action" seems at least defensible. "First do no harm" etc." -- "First do no harm" fails the trolley problem. That's not reasoning; it's just invoking virtue ethics, which IMHO are unethical.
We should at least have a cost/benefit analysis in terms of quality-of-life and of lives saved, and the FDA doesn't do that. It never asks, "Will approving this drug save more lives than it costs?", let alone the same question for quality-of-life.
They give lip service to cost/benefit analysis. But they clearly use those terms in a sort of subjective gestalt-y way, rather than any attempt to be truly quantitative by, for example, attempting to calculate estimated "net years of life lost" from approving or delaying a drug.
By the way (apologies if you've covered it already). But an ideal A-B test demonstrating the FDA's corruption/incompetence would be to compare it's fast track approval of Remdesivir (expensive, patented and ineffective) with its active discouragement of Ivermectin (practically free, already approved as safe, and lots of data showing efficacy).
Or alternately: they do use cost/benefit analysis but not with lives lost. If their CBA is entirely in terms of public perception instead of public health, I imagine you'd get a system that looks a lot like the current one.
Possibly.
Which suggests that getting enough people angry enough with the FDA is the only way to improve it. Probably hard to get the majority of Americans to Scott's level of frustration though!
Probably less than majority that though "these wonderful people just need to tweak their decision making algorithm a bit" would be sufficient
A cost benefit analysis implies the price of a drug is known but it isn't. Drug prices change usually going up over time but then going down once they go generic. (Although you can sometimes get rapid price increases in generic drugs, for example if the market is small and there's only one company that goes through the trouble of setting up manufacturing for the drug).
I think an issue missed here is what do you do with a drug whose benefit is difficult to see in the timescale of a reasonable study? A drug that stops or reverses Alzheimers would be ideal and would have no trouble sailing through a study. The reality is we know Alzheimers is a very difficult disease and most likely the best drug we are likely to get before we get to science fiction level technology (i.e. rebuilding brains with nanobots) is one that goes to work early in the process lowering symptoms or delaying the onset of the disease years, even more than a decade later.
The surrogate marker appears to be the only way to get at drugs that fit in that category if we don't want to wait 10-20 years to learn if a drug will work. Perhaps some of the angst here is that all the benefit of the drug derives to the company today and if 20 years in the future we learn the drug did absolutely nothing, well everyone's moved on.
Drug companies are attempting to cover the costs of approving the drugs that get through the process, as well as the failed attempts. They have to cover it during the period where the successful drugs are covered by patent, because afterwards they are competing solely on price with other companies that didn't pay for that approval. It's not surprising that the price is variable and high, then falls sharply once the patent expires.
Yes you probably know this but I felt it necessary to explain it again.
Yes, however economics says the price should be 'what the market will bear'. Think of a movie studio that has had a lot of big budget flops. When they get a hit, you don't go to the movies and discover that movie costs ten times as much "because we have to cover all the money we lost on the previous 75 Suicide Squad movies we made". It is what it is and hopefully a studio doesn't get too many duds.
This question though gets very tricky when there's no obvious market mechanism in place. With movies it's very simple. Either peopel are willing to pay ten times the ticket price or they aren't. If they are, the studio will recoup their lossses, if not the studio will eat them and hope their future movies will be more hits than Suicide Squads.
"What the market will bear" becomes very fuzzy when you have both patents (government interference in who can make the good) and insurance markets (government interference in both who can purchase the goods and at what price, as well as the ostensible customer not knowing what the price is, let alone paying it).
Movie making has its own interference such as subsidies to make movies in certain places with certain classes of people or companies, but drug making has much more. I don't think "what the market will bear" is a useful heuristic.
Well ultimately we as a society are willing to say we don't care when it comes to movies. If DC studios can't make a great Justice League followup because they had so many bombs investors pull the plug on them, we as a society will shrug. If you can't afford the movies because you spent all your money on vaping stuff, we shrug.
Not a call we are willing to make with life saving drugs unless we are willing to mandate insurance ala Obamacare.
You don't need to know the cost of a drug for the FDA to do a cost benefit analysis. The cost is side effect/death vs lives saved/improved. The cost of the drug is mostly irrelevent.
Agreed, but perhaps to flesh this out more, I think there's two cost/benefit calcs to be done.
If approval and insurance coverage were decoupled as Scott suggests, there's a cost/benefit on whether you should approve a drug at all (is it safe). Then there's another cost/benefit on whether your insurance should cover it (is it cost-effective).
When you go down this road you quickly get to "how many dollars can we afford to spend to save 1 life", QALYs, and then people in the US start shouting about death panels. But with limited resources at some point you do need to do cost/benefit to decide how to prioritize who gets the treatment that they need and who doesn't.
For sure, the devil is in the details. But I think some variation on Scott's 5-Star system is the most straight forward. There are way too many shades of grey and evidence is shifting over time (and tons of arguments on whether or not study X was properly powered, biased, p-hacked, etc). Plus we are barely even scratching the surface on understanding how drugs work with different genetic populations.
The FDA can say "this drug improves outcomes for people in profile 1 by 2.3 years, and people in profile 2 by 8.2 months. It raises the risk of heart attacks by 30%." And on and on. Be the clearinghouse for that, the one-stop-shop that people go to.
Deciding "is this worth paying for?" needs to be someone else's job. Maybe the numbers come out to be $100/QALY or $billion/QALY. (Maybe, *maybe*, the FDA could even come up with that number, too, but that's as far as they should go.)
I feel this is already done by the FDA. The FDA will accept a drug with dangerous side effects if it is offset by serious potential benefits for patients with very dangerous diseases. For example, consider most chemotherapies are pretty harmful drugs but are used in cancer because the alternative is uncontrolled spread and death. If someone invented a drug that treated restless leg syndrome but had the same risk profile, I suspect it would be a hard sell to the FDA.
that's not evidence they do cost/benefit analysis though. That's evidence that they have approved drugs with severe side-effects in some circumstances.
Well this is from the FDA's web site:
"FDA physicians and scientists then review the drug research and the labeling information on how to use the drug. If the findings show the drug’s benefits outweigh its known risks — and that the drug can be manufactured in a way that ensures a quality product — the drug is approved and can be marketed in the U.S. The FDA will continue to monitor the drug post-approval."
https://www.drugwatch.com/fda/approval-process/
That seems to indicate they balance possible side effects against the medical benefit of the drug.
What they do NOT do is an economic analysis where they ask if the drug's net benefits are worth the current list price of the drug.
real world evidence (as outline in this very newsletter) seems to suggest that it is not a robust cost/benefit analysis or at least not solely c/b.
FDA should not get involved in how drugs are priced - so not sure how that's even relevant.
They may say that, but it sure seems like first they inflate the risks by several magnitudes, and only then weigh them against the benefits. Relatively miniscule risks prevent them or delay them from approving tons of drugs with proven benefits that far outweigh those risks.
They should at least use cost-benefit analysis in determining the standards they're going to use in their approval process. And those standards are much, much too risk-averse.
Better said, of some risks but not others. There is a probability distribution of both benefits and costs. There is a risk of not approving a highly beneficial drug and a risk of approving a drug with horrendous side effects.
True. "Risk-averse" is a pretty meaningless term when you think about it. Though I think it's commonly understood that the phrase refers to "risk of something bad *happening*" and not "risk of something good *not happening*".
But we should expect a better than common understanding of risk from the professionals of FDA.
From the FDA's site:
"FDA physicians and scientists then review the drug research and the labeling information on how to use the drug. If the findings show the drug’s benefits outweigh its known risks — and that the drug can be manufactured in a way that ensures a quality product — the drug is approved and can be marketed in the U.S. The FDA will continue to monitor the drug post-approval."
The FDA does formally use cost benefit in terms of comparing the drugs benefits to drawbacks. It does NOT do a cost benefit analysis in terms of monetary terms. If you had a drug with a very minor benefit, like a mild sleep aid, but a side effect profile that looks more like strong chemotherapy, it would have a tough time getting approved.
The other thing we need to unbundle, is drug *endorsement*, unbundling "effectiveness" from "safety". Somebody needs to be in the business of looking at the evidence and saying "yes, this drug actually is an effective treatment", because having all the doctors read all the articles in all the medical journals is not a realistic option. And Derek Lowe is too busy and we all want you to occasionally write about things other than pharmacology.
There's no harm in the FDA approving a drug about which the best that can be said is "mostly harmless", if that's all they are doing. That gives us a long list of mostly-harmless, mostly-useless drugs. And if you're going to have a government bureaucracy telling people what they can and can't do, "you can't inject dangerous stuff into other peoples' veins" is probably a good place to draw that line. If someone else is compiling and evaluating the data on efficacy and sorting everything into "wonder drug", "OK treatment", "might help if nothing else does", and "placebo" categories in a readily accessible way, then we get the outcome we want. But if nobody else is doing that, then doctors and patients and insurance companies are all going to look to FDA approval for that.
And that either gets us lots of prescriptions for mostly-harmless, mostly-useless, $50,000 snake oil, or it gets us prohibitions on putting fish oil in IV nutrient for infants.
These are slightly unbundled, in that doctors can prescribe drugs off-label, if FDA has approved them for some other disease. Before 1962, they were much more unbundled. FDA's focus was safety and purity and drug innovation was more robust, as Charles Hooper and David Henderson showed last year. https://twitter.com/regardthefrost/status/1322681972628443137?s=20
Someone had a good rebuttal to this in a previous comments section to the effect of "look at the side effects of cisplatin and tell me that drug is 'safe'". Most drugs are unsafe, to the extent that you would not want to eat them for no reason. Risk/benefit is the only way to look at drugs.
What that rebuttal tells me is that the safety rating should not be a boolean. Ok, what about a 5-star side effect rating, which we can then compare with the drug's effectiveness rating, and perhaps the severity of the condition? You can still prescribe based on risk/benefit, but measuring and certifying risk and benefit separately looks like a huge improvement over what we currently have.
It looks to me that the bigger problem is lack of urgency. The FDA doesn't factor in that taking time to decide something kills people. Unbundling risk and benefit means now you have two offices you have to wait for.
Yes, all these ideas would help. Unfortunately, any healthcare reform efforts immediately get stuck in the fetid mire of U.S. Politics.
(I've written my perspective on aducanumab here: https://denovo.substack.com/p/a-travesty-at-the-fda It's particularly infuriating when compared to the non-approval of COVID vaccines.)
I have had this exact conversation with my Congressional representative -- that as long as "this drug is safe enough to sometimes try to use" and "this drug is so effective it is a crime for health insurance not to cover it" are conflated, the health care system will both waste tons of money and needlessly delay drugs.
I'm not at all confident anyone will do anything about it. The Democratic majority in the house appears less interested in legislating and more interested in organizing protests. And the Republicans are even less interested in fixing anything with the American health care system.
I think the lawsuit happy legal environment in the US should get a lot of blame for this also. There are many useless and wasteful things that I have to do in medicine mostly because of the fear of getting sued. I believe many guidelines are developed with this as a background threat also and tend to trigger too many follow-up tests and exams.
Do you think there's something to learn from the EU? IIRC Tabarrok has been banging the drum for reciprocity in regulatory approval for years. Not that any of this matters unless and until Congress becomes capable of writing and passing legislation again.
I agree with Tabarrok on basically everything. I haven't read all his stuff, but I didn't think he thought the EU was necessarily better than us - I thought he just felt like we should have reciprocity with them to give two chances for approval instead of just one. I agree with this.
Also, it means that a pharma company only has to pay a billion dollars to get a drug on the market, rather than a billion on FDA approval and another billion on EMA approval (IIRC, it actually works out more like 800m on trials and 200m on FDA bureaucracy and 200m on EMA bureaucracy, so 1.2bn, but still).
What benefit does it gather for a different bunch of bureaucrats to assess the same evidence to essentially the same standards.
It is so stupid that we have to run trials in the US for US approval and in Europe for European approval. If the rest of the world was like that there just wouldn’t be any medication for 80% of the worlds population. That’s also how you get into the situation that we still can’t have access to the AZ vaccine here
And Japan, and Brazil, and ...
Yeah Japan is usually also that way but I have seen them ok something before where it wasn’t really a Japanese trial and you can also get away with a global trial with just 1 site in Japan. Usually we ignore everything besides us, eu, and Japan
Is this just protectionism? Want to access our markets? Then you have to subsidize our biomedical research infrastructure.
Probably not pure protectionism as many countries have independent approval processes without a homegrown pharmaceutical industry.
This reads as if it is informed by conversations with CDC personnel and not with conversations with FDA personnel, or just based on a bunch of third-hand reporting. FWIW, the real issue here was Trump/Bannon's dismantling of the Global Health Security and Biodefense unit in the National Security Council, which was responsible for pandemic preparedness. In my opinion, you needed someone at that level to bang heads together as between CDC and FDA, and to get the President to make a decision. The rest of the piece is interesting, occasionally useful, but quite misinformed.
Better, more informed, and accurate criticism, please.
That's really not helpful, either for the discussion generally or for making your argument look sound. You are acting like you have a hammer, and so everything must be a nail.
You might want to be a bit more specific there. This isn't Twitter - you can use full sentences, and in this crowd you should.
I genuinely have no idea what you're objecting to, other than the fact that he's on the other side of the issue from you.
Thanks--that's a totally fair comment, and very helpful. I'll respond now to the bits that set me off, and I may respond more fully later to the inferrable content in the one sentence I found meaningful.
trebuchet's way off-base "restatement" of what I was saying _is_ lousy criticism. It's not even in the same ballpark. It's entirely fair for me to refer to that and ask for better criticism than that. If you don't see the difference between what Trebuchet said and what I said, let me know, and I'll try to clarify.
And then there's the "orange man" reference. That is entirely irrelevant to the argument I was making. It's the kind of statement I've seen before from those on the right who erroneously suggest that I'm making ad hominem arguments when I am not.
So that leaves one sentence, which assumes its erroneous conclusion. FDA didn't feel "compelled to prevent highly qualified doctors and scientists from testing for a deadly virus"-that was the outcome of what could be described as a turf wat between FDA and CDC. There are, arguably, any number of things that are wrong with the FDA. Most of them are "fundamentally" caused not by FDA, but rather by a dysfunctional Congress since about 1994.
So I hope that helps you see why I'm asking for better criticism. with the exception of the "deeply and fundamentally wrong" point, the rest seems to me to be pretty easily recognizable.
I can see why you don't feel like his summary accurately represents your view, but I can also see why he thinks it does. And since I lean more to his view, I'll elaborate a bit.
Basically, the FDA and CDC are medical agencies who work in this space - the CDC ought to *be* the pandemic preparedness agency, not need an external one, and the FDA ought to have programs in place for expedited approval in emergency situations. Some small(at least, by comparison) coordinating office ought not to be required for them to have done those things. If the lack of a National Security Council unit was the deciding factor here, the CDC/FDA pair were incompetent to begin with. And likely, incompetent to the point where the NSC couldn't realistically help the situation much.
Re "orange man", you specifically named Trump and Bannon in your first comment, and said that their action was "the real issue here". That makes it seem like issues with Trump were a big part of your concern. And, per my last paragraph, I have difficulty seeing how this decision had any effect on the things we're taking the FDA to task for. It could plausibly have saved a day or two in January by monitoring the world situation, but that doesn't seem to have much to do with which test kits get approved or banned.
Re the turf war thing, wasn't the whole issue that the FDA trusted the CDC so blindly that they banned everyone else? That sounds like the exact opposite of a turf war to me.
Re the dysfunctional Congress, that'd be a better explanation if these issues were only post-1994. I wasn't paying much attention to politics before that, but my understanding is that these issues predate that by decades.
Thanks! There are too many "oughts" and "seem like" and "likely" "makes it seem" for me to really want to respond here. Those all represent your assumptions about the way the world _should_ be. Your "oughts" weren't the facts on the ground at the time, or even now, so the points you make based on those assumptions are hypothetical, to me. Same point with your likely--it's pretty much assuming your conclusion. Issues with Trump qua Trump? I don't care. Issues about Trump making many appointments to HHS (writ large, not just the mothership) that I thought were pretty bad? I care about that a lot.
How did Trump's decisions affect anything outside the two-ish paragraphs about COVID testing? In fact, how did Trump's dismissal of a different branch of government cause the FDA to ban COVID testing?
I agree that many bad things happened to screw up a potential US test-and-trace program, and Trump's decisions were among them. But I also think that we could have recovered (maybe not completely, but at least partly) from our government's bad decisions if labs/universities/hospitals etc had been allowed to take up some of the slack, and that the FDA's ban on that was genuinely really bad.
I think "Trump knocked the US response down" and "...and then the FDA prevented it from getting up" are perfectly compatible.
As for the rest of the piece being misinformed, if you're going to accuse me of that I've got to insist that you be more specific.
FDA didn't ban COVID testing; it restricted it to CDC's tests, which were problematic, to say the least. FDA "prevented it from getting back up" because of miscommunication and miscoordination between FDA and CDC-FDA thought CDC had a functioning test. That miscommunication and miscoordination would have been resolved by a functioning Global Health Security and Biodefense unit in the NSC-think of this aspect of it as the semi-circular canals of pandemic response: "Hey, our center of gravity is way misaligned here-better straighten up, or we're going to fall over."
You have a good point about "misinformed" regarding the rest of the piece; I apologize for me poor wording-my judgment was influenced by your writing about the testing. A better choice would have been "unrealistic", as I think you largely acknowledged. The outcomes you're calling for might be improvement (ignoring significant potential unintended consequences), but unless you're willing to even sketch out a realistic path to achieve them, I think "unrealistic" is a fair description.
No, the FDA stopped private labs from offering in lab covid tests, and dragged its feet on approval. To be absolutely clear, the FDA act doesn't govern lab-developed tests the same way in ordinary times. They acted in a way that made the problem worse, illegally.
aren't you evading my point about why FDA did that.
The FDA did not have to exceed what the black letter law says about regulating labs only to get slapped down in courts months late. The FDA did not need to mandate labs validate tests with samples they couldn't get. Even given CDC had a working test, there is no harm in letting Quest run its own tests as well.
Responsibility for the FDA's actions lies in the people who took them. The idea that the FDA needs adult supervision to do its job only underscores the need to sack everyone in that building. Responsibility for not correcting those actions lies with the HHS secretary and ultimately the President.
It's not about "adult supervision"; it's about turf wars between different agencies, and you need someone with authority to settle those disputes. "sack everyone in the building"-you do know that 18,000+ people work for FDA across the US and overseas, right? You're right about responsibility being with the HHS Secretary (who normally doesn't coordinate these kinds of disputes) and ultimately the President, but you're at least partly wrong about the nature of the problem.
The FDA did that for the same reason that they do most things - they're professional paranoids, and live in a dream world where everything they touch is secretly thalidomide in a trenchcoat.
And you wrote that because you’re ignorant of the FDA.
Lmao so true
"FDA didn't ban COVID testing; it restricted it to CDC's tests." This is a non-sensical statement that does not address Scott's point, or any of the reporting on this subject. No one thinks that the FDA issued a statement saying, "NO ONE IN THE UNITED STATES SHALL TEST FOR COVID!" That would be absurd. We know they're not mustache-twirling villains. What people think happened, and what this article alleges, is that the FDA only allowed a type of testing which didn't really exist, which you admit when you say "The FDA restricted testing to the CDC's tests." Everyone outside of the FDA was aware that there was no viable testing apparatus being provided by the CDC, so why was the FDA forced to pretend there was one until and unless Trump stepped in?
"So when I talk about unbundling FDA approval, I mean that instead of the FDA approving the following bundle of things…
It’s legal for doctors to prescribe a drug
It is mandatory for insurances to cover a drug.
…the FDA can say one of those two things, but not the other."
FDA has no authority over insurance companies.
My understanding is that it's not a black-letter law they have to follow. Instead, it's precedent - if it's FDA approved, and someone kvetches at them for not covering it, the kvetcher usually wins the ensuing lawsuit. Or at least the PR battle.
This does, of course, make it somewhat harder to fix.
HMOs were extremely effective at keeping costs down by saying "no, that's not worth it." They gradually lost the ability to say "no" by lawsuit after lawsuit.
The history of radical chemotherapy should be instructive here.
A quote from a piece on Politico which was entirely sympathetic to the FDA (https://www.politico.com/news/2021/01/19/fda-trump-pressure-coronavirus-vaccine-460402):
<quote>
The coronavirus pandemic revealed a “clash of cultures” between the White House pressing for faster progress on vaccines and treatments and the Food and Drug Administration’s efforts to stick to the science, outgoing Commissioner Stephen Hahn told POLITICO.
“I heard loud and clear from the White House — President Trump and others — that they wanted FDA to move faster,” Hahn said in an interview Tuesday, less than 24 hours before President-elect Joe Biden is scheduled to take office.
...
“With time, particularly over mid- to last summer and then into fall, there was a substantial amount of pressure,” said Hahn, who took the helm at FDA a little over a year ago.
</quote>
The Trump administration pressured the FDA to move faster on vaccines throughout the epidemic. This caused the entire US media to align itself with the FDA, and literally every article I've seen on the topic presented the FDA's foot-dragging as standing up for science and rigor in the face of Trump's lunacy. If not for that, this new Atlantic piece would likely never have been published.
Scott cited the investigative journalism done by the NYT so you know what informed his writing. What part of their characterization of COVID testing mismanagement do you think are misinformed?
The FDA acted like most government agencies at any level - not with malice or hatred but bumbling ambivalence. The solution to that isn’t adding more bureaucrats to “bang heads together”. The solution involves evaluating and changing the incentives of the stakeholders.
That's a misinterpretation of the one article I looked at. How about you provide a specific link to the specific article and quote the text you think establishes this?
Nah, Dude. That’s on you.
You made the claim that his post was informed by “a bunch of third-hand reporting”. So “how about” you read more than one of the articles linked if you’re going to imply the source material was too biased for the post to have any use?
Then you’ll find the article about Helen Chu’s kafkaesque tale of fighting with CDC/FDA/IDGAF bureaucrats to do the right/best/sane thing.
I read one; Scott misinterpreted it, and you expect me to read the rest? Please.
Let's start by asking this - which article, and what was the misinterpretation?
Great question! I will get back to you on this.
Agreed. And then The GodfatherBaritone should do the same.
So many people on line make some sweeping statement about some article they read, and then refuse to be more specific when asked.
I don’t know how much time I’ve wasted trying to find those articles, and coming up blank, but I’m sick of trying.
This is SSC/ACX, and we have a higher standard of discourse here.
Can you explain in detail what happened, and what people and processes and organizations really caused this? You sound like you know a lot, and are understandably upset at people assuming things, and I’d really like to learn more of what you know here + links to good and long articles to read if you know any.
I second this
Subject to confidentiality and huge current demands on my time, I will, when I can.
Seconding bored-anon's request. You sound like you know a lot, I'm interested to learn from you.
That unit was one person that does nothing but chairs meetings of the interagency that go on anyway and then writes a summary of conclusions that people yell about and occasionally makes a read book for their boss if they care. Its not some far reaching unit of people who actually do things, its normally like one person from the CDC or DHS or State on rotation for a year who just does their job in a cube at EEOB instead of their agency HQ. Do you have any idea how the NSC actually works?
I do, at least a bit. That "unit" was a directorate, with permanent staff, prior to the dismantling under Trump/Bolton. Just to be clear, I'm talking about the National Security Council Directorate for Global Health Security and Biodefense, which was headed by Rear Adm. Timothy Ziemer, who reported to the NSA. What are you talking about?
Was his reporting to the NSA on the offensive or defensive side of cyber warfare, or on some other part of the NSA's portfolio? What does "Global Health Security" have to do with US-internal review and approval of diagnostic tests, given that the rest of the world had plenty of perfectly functional tests for the same disease? How much actual authority do you think that "Directorate" had in less than two years of existence?
You are stretching really, really hard to find some way to blame the CDC and FDA screwups on COVID-19 diagnostics on Trump's White House, and you have yet to show any defensible link between the two.
The three people in the NSC, two of which were simply moved to the counterproliferation and biodefense directorate in the NSC, still working on pandemic response after the re-org, had approximately zero effect on pandemic preparedness. They didn't direct the CDC or the FDA or anything, they wrote and discussed reports about pandemic preparedness to help keep the NSC keep informed.
See also https://www.washingtonpost.com/opinions/2020/03/16/no-white-house-didnt-dissolve-its-pandemic-response-office/, plus numerous fact checks from various organizations about the elimination claim.
Yeah, I've read that WP article, and many others. What you're saying is entirely accurate and entirely irrelevant; I was responding to what Mike I said about the Directorate. And you don't address the elimination of the Director position. I mean, they don't put Rear Admirals in positions just because they like the pretty shoulder boards (well, usually.....)
To be more explicit: it would have been Ziemer's role to sound the alarm to the NSA who should have passed it along to the President ("Hey! We don't have tests! Here's why and what we should do about it!"), and to convene a Cabinet-level meeting, etc. So this isn't about "pandemic preparedness", this is about the stature of the Directorate and its ability to get Cabinet-level and Presidential action.
Why would they be better at that than the CDC/FDA heads? There's literally over 200 people of Rear Admiral rank or higher in the USN(https://officerassignments.com/vice-admiral-vs-rear-admiral/#:~:text=In%202015%2C%20the%20United%20States,35%20Vice%20Admirals), and probably close to a thousand of equivalent rank in the whole military. It's not like any President was likely to know the guy by name. Ziemer > O'Brien > Trump isn't any faster than Hahn > Azar > Trump. (That path would be faster on a scale of minutes, but covid isn't an ICBM, and doesn't operate on that time scale.)
that department still exists - trying to blame crappy COVID response on minor org reshuffling is misleading at best. And claiming that a government bureaucracy that has never faced a true test would have made all the difference is rather far fetched.
https://www.washingtonpost.com/politics/2020/03/20/was-white-house-office-global-pandemics-eliminated/
"People are really scared of this solution, because it introduces choice into this system. If you say that insurance companies are allowed to cover a certain drug, but not forced to do so, then different insurances will cover different drugs, and you’ll have the usual capitalism / free market thing."
Unfortunately, you will not. There was a SSC article (or many) covering exactly this. Most health insurance is through employers, and there is often no real choice at all (choose between Plan A or Plan B with minimal differences). Even when there is real choice, it's rarely of the meaningful I'll-take-a-no-aducanumab-plan-for-$100-less-a-month variety - instead, usually it's high-deductible vs low for the same services. And even when there's real choice, it is borderline impossible for anyone to learn enough about the differences to make an informed choice, let alone a rational one comparing risk-adjusted costs and benefits.
Theoretically, sure. But in practice, captitalism/free market choice effects is not how (private, US) health insurance works. SSC has covered this quandary perhaps better than anyone else, so it's odd that this paragraph would be included with a disclaimer or footnote or something.
> Most health insurance is through employers, and there is often no real choice at all
Isn't that also because the law doesn't allow them to offer choice?
Yes, but I don’t think it would make a difference. If you’re a company benefits administrator, would you rather deal with one insurance company or 10? Would you get a better price if you had 100% of your employees on one plan or 10% on each of 10 plans? And aside from the few candidates that have a specific rare health problem and need a specific thing to be covered, I don’t think you’d see any real recruiting benefit from offering more choice.
They wouldn't need 10 insurance companies, just different plans from one company.
Employees looking for a job ask "Who is your insurance carrier?" and almost never ask "and can you give me the Summary of Benefits and Charges?" I've never known a single employee to ask about the actual list of benefits and charges, which is hundreds of pages long and covers thousands of treatments that you and I have never heard of and will never need. Even if they asked and read them in detail, it would be impossible for anyone to make a truly informed decision about which plan really fits them best. They'll maybe have some family history and take the plan that covers cancers better or something, but that's rare and still unpredictable. Maybe they got the wrong kind of cancer, or got heart disease, or maybe never have a major medical issue. People tend to work at the same company for periods of time in which their health care needs change.
Benefits managers are highly incentivized on costs, and get mostly noise and gibberish otherwise.
In my professional life, I've had no problem getting a detailed list of benefit from HR. "My wife needs to see it," I say, and it gets coughed up pretty fast, because it's not like it's a secret or anything.
(And my wife *does* read it and says "this is good" or "this is crap.")
But we have Bronze / Silver / Gold that got established through Obamacare, and those mean something, right?
Those things certainly exist, and I don't doubt that some people have looked at them in detail. As I mentioned, some people know of family history that would make certain types of testing and treatment more important for them. From the perspective of a benefits manager, trying to determine which plan to use, there just aren't enough people doing that to move a company towards or away from plans based on the specifics of coverage. Maybe at a very small company, a voice or two could probably reach the manager and shift attention.
Bronze/Silver/Gold are actuarial differences, and don't really tell you whether "Procedure X" is covered or not. Obamacare actually got rid of a lot of the variations in what is covered, so that plans are far more standardized now than before.
I don't think so. It's been a while now, but I don't remember this changing materially before and after the ACA. The only things I really noticed were the lifetime limit disappearing and checkups becoming free. The amount of choice either within a provider or between the two providers my work offered didn't change in other ways that I found noticeable.
Is the concept of “choice” coherent in health insurance? How can one choose a plan that may or may not cover a future illness that may or may not be treated by an as-yet-unapproved drug? The attempt to impose free market concepts to healthcare is fraught from first principles - everything isn’t a widget.
Then why does it work so well in veterinary medicine?
Or cosmetic surgery. Boob and nose jobs are almost never covered by insurance, and yet there is a thriving competitive free market in them.
That's true. I want to say that employers exercising choice is better than nothing, but I guess the "employers will only select good insurances because they want to attract workers to work there" incentive chain is so tenuous as to be almost nonexistent.
But is that a circular problem? It seems tenuous today because insurance companies are undifferentiated in what they cover, because the law mandates it be so. If it didn't then insurance companies might start trying to build brands on only covering the right things, and that would feed through to employer policies. It might also incentivize the unbundling of health insurance from employment, which is not inherent to the insurance/regulation model but just a historical quirk of the US market.
But the problem is if some cute kid or sympatric adult is dying of some disease their insurance won't cover the public will insist it be covered. We sure as hell won't say, "Well, you decided to save $100/month buying the insurance that clearly stated on page 543 of the contract that they don't cover that specific treatment for that rare cancer so too bad."
It's a problem for sure. Health insurances can cover a lot of things that aren't exotic cancers though. In Switzerland a lot of policies famously cover massages. Note: not expert medical massages for people with exotic muscle problems. Massages in general, for anyone. That sort of "lifestyle health care" is where they can differentiate.
Isn't massage coverage pretty common? Here in Canada a typical employee benefits package might be dental, life/AD+D insurance, prescription drugs, and 'extended health' (massage, physio, counseling, chiropractic, etc.) and providers compete on the specifics of coverage limits, which brand-name drugs to cover vs. generics, co-pay percentages, that sort of thing.
... and federal civil servants complain about their conspicuous lack of massage coverage compared to every private employer anywhere. Their package is pretty good otherwise though.
The incentives between insurance companies and employers offering insurance is to be very streamlined to what people tend to want over the timeframe the employer considers relevant. That means weird treatments that cost a lot of money and help few to no people are out. Standard fare regimen treatments for conditions like diabetes and high blood pressure are covered well. Rare items might be covered as well, if they are common enough and treatment is predictable enough to cost it out (think breast cancer or open heart surgery, but not weird diseases nobody has ever heard about).
Disagree. Those ones are cheap to cover, because they're so rare, and people raise a stink when they get Unheardof's Syndrome and find out it's not covered. It's just that a lot of those niche diseases have extremely expensive treatments, because there's so few patients to amortize development/approval costs over, and those extreme costs per patient are what drive insurers away.
Rare diseases are an easy cut for insurance companies, because hardly anyone ever complains BEFORE they have the disease, and if they complain after the company has saved millions of dollars in claims by not covering it. That is, if they're allowed to cut them piecemeal. Sure, 200 people across the country may get screwed when they contract the disease, but most people will go on never having heard of it and not complaining about it.
The problem with this is that the "if it didn't" was recent, and we didn't see that kind of thing. At least, not to my recollection. Other over 40s, anyone remember this differently?
Insurances will at least be able to lower their prices? That might be good
>Most health insurance is through employers
I mean, to be fair, "we need X" and "the ideal is Y (which depends on X)" aren't really contradictory. X in this case is "abolishing employer-based health insurance".
I used to sell group health insurance. There's definitely some differences in which insurers and which plans cover what. And if a wider variety of coverage levels were legal, you'd likely see more choice.
It'd be trivial for insurance companies to offer policies that cover the 2*, 3*, 4*, or 5* formularies, and also fairly easy to explain. And even that very simple level of choice would help a lot with cost control. If you want more choice than that, you'd probably have some intermediate formularies that get assembled by some big prominent medical association to split some of the differences.
Making what a policy covers more legible, would be a good idea anyway.
"Consider the police..."
The police also face incentives to be lax when they should be strict and vice-versa. A crazy guy might fight back - better stay away and not get hurt. And someone making money might have stuff worth seizing through civil asset forfeiture.
And if the crazy guy *does* answer the door and *does* attack them and they *do* shoot him, every piece of news media from here to Mars will have articles on how they should just have talked him down, or let a social worker handle it or something, instead of murdering in cold blood a poor sick man who had done nothing wrong. I can see why they'd decide "well, we tried knocking, nobody home, let's not kick the hornet's nest" and then leave.
This is somewhat off-topic but Scott's regard about the police seeming omnicompetent compared to the FDA made me think of my own changing views on them. During the GWB administration I would have told anyone that the police are simply the largest organized criminal gang in any city, who commit crimes all the time with impunity. Importantly, crime had been going down for most of my lifetime. Since 2014 and 2020 I have learned what happens when the dominant gang steps back and lots of little gangs are unrestricted enough to shoot each other up and probably not get caught.
I think the most direct and simple, if incomplete, example of this is to compare how many police kill with how many they arrest. There's a lot of rhetoric about how police go around killing whoever they want whenever they want, but they arrest around 10,000,000 people a year, and only 1000 end up dead. Given that their job is literally to forcibly control people, I think this is not that dangerous a ratio.
And somewhere over 900 of them turn out to have been armed.
That said, it's still a pretty bad ratio compared to police elsewhere. Per capita, US police kill at least an order of magnitude more than most other developed countries. Some of that can be chalked up to the American public (much more likely to be armed, and often less fond of compliance with authority in general), but not all. There's some real issues in American policing practice.
>And somewhere over 900 of them turn out to have been armed.
In America you have a near absolute right to be armed. That doesn't excuse the cops shooting you.
The police in America have a conception of themselves as being uniquely endangered (they aren't in the top 10) and as therefore being uniquely justified in doing whatever is necessary to come home ("better to be judged by twelve than carried by six"). This culture leads to a lot of preventable deaths.
I also happen to think that our gun culture does that as well, but I don't think the armed thing should be a qualifying excuse. Especially since most of those guys vote for the political side that brought us lax gun laws over the last generation or so.
1000 a year is not "a lot" of preventable deaths.
Sure, I mention being armed mostly to counter one common narrative. (Though of course, a right to be armed is not a right to threaten or attack people, and many of the armed deceased were doing exactly that. Ma'Khia Bryant is an obvious recent example here.)
There are other developed countries with high rates of gun ownership, but without people actually shooting each other nearly as often. And there are places like Russia where the rate of gun ownership is low (if you can believe the official numbers) but people still shoot each other a lot. The homicide rate is going to be a better predictor of whether the cops themselves are trigger-happy.
How many people do they kill per capita compared to how many more arrests and crimes there are?
Per capita, the US has a lot more criminals that most other developed countries. What matters w/re police killings of innocent(*) people is, what is the probability that someone the police approach with the intent of e.g. issuing a jaywalking citation, will turn out to be a drug dealer or whatnot who thinks the cops are coming to bust him for a felony? The higher that probability, the more rational it is for police to rationally approach jaywalkers with a hair-trigger "but this guy might resist arrest with the vigor and violence of someone trying to escape years in prison" response, and the higher the risk of false positives.
* Mostly meaning "guilty but of petty crimes that nobody would imagine shooting someone over", which is of no moral but some practical significance.
You say that, and then my hand aches again. The police abuse people in a lot more ways then just shooting them dead.
And the real problem is not that occasionally one does so. People go bad sometimes. The real problem but then all the other cops were "looking the other way", or close ranks around them. So, yes, All Cops. Maybe All Cops don't break people's hands in roid rage lulze, but All Cops know those who do, and they "look the other way". All Cops.
This is a pointless appeal to emotion, akin to to sayin you got bad symptoms from the covid-19 vaccine and therefore the vaccines are bad. No one cares about what some random bad cop did to you anymore than you would change your opinion about cops because you heard an officer went above and beyond the call of duty to save someone from being raped.
The obvious and correct response to there being police officers who do bad things is to record video, prosecute, and otherwise get rid of those officers. It is not to abolish the police. There are also plenty of policy changes that are not abolishing the police or chanting ACAB, like eliminating civil forfeiture, that would make the police better even if they wouldn't salve your emotions.
If you read the second paragraph of Mark's comment, you'll see that his primary complain is not that an individual officer was abusive but that instead of "record[ing] video, prosecut[ing], and otherwise get[ting] rid of those officers", "all the other cops were "looking the other way"". I agree that the fix is not "no bad cops ever", that's fantasy land, but when the current system is actively opposed to prosecuting and firing bad actors then they do assume culpability even if they aren't themselves actively bad. Police unions are a huge part of the problem here, from what I've read
You cannot overstate the degree to which the culture of the FDA was shaped by the Frances Kelsey/thalidomide experience.
Pretty much true, but partial, if I'm understanding you correctly. An equally big issue IMHO these days is the level of political oversight from Capitol Hill, and lack of resources from the Assistant Director level on down.
This is a good, fair, and understated post from Scott. If anything should be hit harder, it is this point about the public choice aspects of the FDA incentives. Amidst a very long description of how things go wrong, there are two paragraphs that identify a primary root cause of FDA dysfunction, those two about social trust as a limited resource being held hostage to the stupidest person. This could use the same level of exploration. It could even keep the parallels with police, who have similar bad incentives that lead to erring on the wrong side as described.
It's a good explanation of where the institutional scarring came from, but fighting the last war isn't an acceptable level of performance.
I thought Scott (or Zvi?) wrote an article specifically on the subject, but I can't find it at the moment. I'm not up to re-generating it myself, but the gist was that in order for the FDA's LESS/MORE lever position to be justified on those grounds, it would need to be demonstrably catching something at least as bad as thalidomide multiple times per decade - not merely denying approval of obviously harmful things, but outperforming comparable approval agencies that let something hazardous through.
Fighting the last war is what the Federal Reserve does, and they're considered one of the best functioning parts of the government.
Yeah, but it helps that their battle is always largely the same.
No, that's part of the problem. When it was initially founded, the Fed initially caused a very large amount of inflation (WW1 also played a big role). They then decided the stock market was booming too much and decided to pop the bubble, and persistently denied any responsibility for the Great Depression (Bernanke would later say that Friedman was right about the Fed's responsibility, although they differed on a credit vs money contraction being the issue), but FDR devalued the dollar without any of their input and him arbitrarily picking lucky numbers when he felt like it worked better for the problem they were facing (although they still increased reserve requirements to make things worse prior to the depression ending). After WW2 the dominant Neo-Keynesian view among policymakers was that demand needed to be boosted to avoid unemployment and inflation was a relatively minor concern in comparison. Milton Friedman predicted that the relationship between unemployment & inflation would break down, and indeed it did while mainstream economists tried to attribute inflation to factors other than the money supply. Eventually stagflation was an obvious enough problem that Volker/Reagan "broke the back" of inflation and managed to have a decent economy afterward rather than a prolonged slump (the supply-siders played a role there, in an instance where Friedman was wrong). So afterward fighting inflation was the Fed's focus and in 2008 they saw oil prices inching up and decided to contract the economy at the same time it was facing headwinds and again refused to recognize their responsibility. Bernanke's attempt to stop things involved paying interest on excess reserves, a contractionary measure, because he could head off inflation while merely boosting credit enough to save the economy. Now that the Fed is finally coming around to not being terrified of exceeding the 2% inflation target in a single year, you should expect that in an number of decades they'll make the opposite error AGAIN.
Fair, I was being a bit simplistic.
Their goals have been the same throughout, as have the underlying laws of economics. Their tactics have ranged from pretty good to pretty bad over that time. However, because they're always dealing with the same issues, they've generally learned from past failures and improved themselves over time. It's not as easy for most other government agencies.
I agree with this, as an instrumental matter the Fed is much more capable than it was in the 1970s. Brad DeLong has beaten the drum for years about the incompetence of Arthur Burns and in particular, how Nixon had him wrapped around his finger. Unfortunately, competent monetary policy is necessary but not sufficient for a healthy economy.
I don't think their "goal" has been the same throughout. They typically ignore one half of the dual-mandate while focusing on the other.
"Eventually stagflation was an obvious enough problem that Volker/Reagan "broke the back" of inflation and managed to have a decent economy afterward rather than a prolonged slump..."
I've been working under the theory that a cost-push stagflation cycle is not possible in the current configuration of the economy because what breaking the back of inflation consisted of was not just the Fed raising the prime rate above 20% but also breaking organized labor. If labor is not capable of demanding higher wages in response to a decline in the purchasing power of a dollar, then how does the feedback cycle close?
Most of the setbacks suffered by organized labor were too late in the process to be likely candidates for causes. Reagan's mass firing of ATCs was August 5, 1981 (and that's often seen as the first real blow against labor, though in fairness I wasn't alive at the time and I'm just getting this from recollections.)
Inflation peaked at 14.8% in March 1980, and was at 10.8% in August 1981. It was below 9% by the end of the year, and below 4% by the end of the next year. (https://www.usinflationcalculator.com/inflation/historical-inflation-rates/) If unions were a major cause, the causal process would likely be contract renegotiations where the unions got worse deals, the annual wage growth slowed down, and then those savings were passed on to consumers. That's too slow to be fixing things that fast - unions were never a majority of the economy, contract negotiations don't happen instantly or constantly, and lower annual raises don't move that quickly either.
The cost-push theory was just wrong. It was all monetary policy. When Venezuela or Zimbabwe print lots of money, it doesn't matter if they repress independent labor unions or not.
If you unbundle allowing doctors to prescribe medicines and mandating insurance coverage, then I see no reason to think a free market will suddenly emerge in the health insurance industry. Changes to FDA procedure would really demand simultaneous changes to health insurance law and tort reform for doctors and probably some other things as well. It sounds like a recipe for a gargantuan bill that will attract special interests for pork and lots of controversy and probably still have negative unintended side effects. In other words, the FDA is totally overdue for reform and I would take 10-to-1 odds it doesn't happen in the next 10 years.
There would definitely need to be further regulatory changes. Many of the necessary market responses are in fact illegal under current law.
Wait a minute there, Scott. Just because the FDA approves a drug, it doesn't mean private insurance companies legally have to reimburse me for the drug. I'm a Type I diabetic, and every year or so, my insurance company UHC (United Hellish Care) changes up the types of insulins they'll reimburse me for. Since they also have a large retail pharmacy under their wing, [sub]Optum[al]-Rx, I'm sure they're negotiating with the various insulin producers for the best deal. But that means that on short notice I'm given some new insulin which I have to figure out how to recalibrate my regimen around. It's a real pain in the subcutaneous ass tissue.
Or do insurance companies have to cover meds in certain categories, but they're allowed to the select or reject the meds form each category as long as they cover one of them? However, to my mind the effectiveness of meds within those categories seems to be pretty broad. Just sayin...
I am super not a lawyer, but I think what happens is that insurances can declare some drugs to be not on their formulary, but if a doctor makes a case that the patient needs that drug anyway, they have to respond to the case, and if their response isn't good enough, they can get sued for not providing it.
The usual response is "we cover this other much cheaper drug for the same indication, you should just try that one". I expect this is what UHC does with your insulins. There actually are a few other Alzheimers drugs, which somehow haven't made it into this conversation, but those ones also don't really work. I think the main situation where insurances would have to cover this is if a doctor tried the other 3ish Alzheimers drugs, none of them worked (as in fact they will not), and then asked the insurance company to cover this one. I don't think "we don't believe this works, even though the FDA says it does" would go over very well as an excuse.
I'm not a lawyer and this is based entirely on a few articles I've read plus the fights I have gotten into with insurance company representatives.
My experience with insurance companies (employer side) is that you are correct. They make the doctors jump through hoops trying all the generics and cheaper versions. If the doctor is persistent enough, they can eventually call the $50,000 drug "medically necessary" with a paper trail showing all the other drugs failed to work. Insurance companies often refuse to cover the expensive drugs up front, if there are alternatives available.
I mean that does sound like the free market at work. Have insulin prices dropped?
Forty years ago, insulins were not prescription drugs. I remember purchasing insulin and syringes over the counter. Of course, they were not very sophisticated insulins: Regular, Lente, and NPH. They sold for about $10/bottle. In today's money that would be about $22/bottle. And they were just transitioning from insulins rendered from the pancreatic beta cells slaughtered animals to the new process of making it with genetically modified yeast. And we were told that this would make insulin cheaper for the consumer, plus with the miracle of gene splicing we'd newer types of faster acting and newer extra slow acting insulins. The second prediction came to pass, but the first prediction never came true.
The Pharma companies saw these new insulins as a cash cow. From what I understand, they were probably only making 20 percent margin on the old animal insulins, so I would guess it cost them about $7 or $8 to manufacture a $10 bottle of insulin. The yeast production method made the production much cheaper. I've never seen any figures but considering that after a probably substantial upfront investment in the yeast growing tanks and the refining equipment, these plants can run continuously. I'd be willing to bet that once the costs plants were amortized over a 4 year, it cost big pharma about $2 to manufacture 1cc vial of insulin. But the savings were NOT passed along to consumers.
I don't know whose regulatory arms they twisted but big Pharma made the new insulins Rx-only. And they've been steadily raising the prices over the past 30 years. My fast-acting Humolog costs about $250/1cc vial, and it will provide me enough insulin for about 12 days.The new super long acting insulins sell for $350/1cc vial. Because I use less, one of those vials will last almost a month.
I used to purchase insulins from my local pharmacy, but United Hellish Care evidently stopped reimbursing the small independents enough for them to recoup their costs. Suddenly my friendly neighborhood pharmacist who I had used for 20 years started looking stressed and worried whenever I refilled my Rx's. I didn't know what was going on, until the trainee sales clerk handed my vials with a sticky note on them, and in a tight little scrawl: "Pham, what are we going to do about this?! We're losing money on this Rx!" The scales fell from my eyes. I spoke to the owner, and we had a heart to heart. He admitted that he was running a business and that they were losing money on selling me insulin. I felt bad for him. And outraged at the same time.
Meanwhile UHC was urging me to use their OptumRx mail-order pharmacy. And they were dangling the promise of filling 90-day supplies of insulin (a privilege which they never granted my local pharmacy). So I went with them. The co-pays are the same. But I figure they've got the buying power to negotiate deals with Big Pharma to get their insulins cheaper than my local pharmacy can.
Of course, we blame the insurance companies for this mess. But its not the insurance companies who jacking up the prices of insulin (or any other meds for that matter).
BTW: I checked the prices for insulin in Mexico. I could purchase them over the counter from Mexican pharmacies for about 1.5x what my copay is here (although they don't seem to carry some of the newer types). Likewise insulin is much cheaper in Canada. Canada sets maximum wholesale costs for what Big Pharma can charge. I don't know what Mexico is doing, but somehow Big Pharma hasn't gotten its claws into Mexican health care. So Big Pharma is screwing over US citizens because of the way we've got things set up here.
That's utterly maddening. Running bioreactors is hard, you've got to know what you're doing but it's certainly a hell of a lot more efficient than harvesting pancreases from pigs. More and more, I'm coming around to Matt Stoller's point of view that market power & oligopoly are the dominant reason for the dysfunction in markets. It's the simplest explanation for how pharmaceutical companies are not just capturing all the productivity gains from improved manufacturing but raising prices on top of that.
You have to add US subsiding drug development for the rest of the world into this equation or you aren't getting the whole picture. Its not like pharma companies are extraordinarily profitable (4% net margin IIRC)
I agree with @bored-anon. Sounds exactly like the free market at work.
Are the old insulins still available if you want them?
If not, are they considered obsolete because the new ones are so much better, or was there some coordinated effort to deliberately kill that market?
They don't make the old animal-based insulins anymore. One can still buy a bioreactor version of Regular insulin over the counter (but almost no pharmacist will not believe you when tell them that's it doesn't require a prescription). I think it retails for ~$150/1cc vial.
What's the justification supposed to be for making insulin prescription-only? Is there some weird recreational use? I understand injecting yourself with a bunch of insulin you don't need is a bad idea, but that's true of all kinds of OTC medications if you take enough of them at once.
Well, back in the late 40's there was fad for losing weight through insulin injections. But that didn't really last long. People really didn't get into the whole injection thing and amphetamine pills became the preferred choice of savvy dieters. ;-)
Also, there may have been some people murdered by perp injecting them with insulin.
https://journals.sagepub.com/doi/abs/10.1258/rsmmlj.67.4.147?journalCode=mljc
I was under the impression that that's also the case for Medicare/Medicaid - that drug approval was a separate thing from them deciding to cover it. I was surprised to read otherwise, since I seem to remember quite a few instances of a healthcare provider family member not being able to offer certain (definitely-FDA-approved) drugs to people on Medicare, since they wouldn't cover it. Nor would private insurers, of course, but typically those patients would just pay out of pocket.
I have experienced non-generic medicine being hit-and-miss with different insurance companies. Some will, some won't. I have some insiders I can ask and will try to follow-up here when I do.
"The answer is: to a first approximation, insurance companies have to cover anything the FDA approves."
I don't think this true. Novo Nordisk just got approval for a drug called Wegovy (semaglutide) for weight loss. The trials were quite impressive. The drug was first approved as a Type II Diabetes treatment and is sold for that indication as Ozempic.
My daughter lost 100 lbs on Ozempic, so I asked my doctor about it. He is wiling to write a prescription for Wegovy, but Medicare has made it clear that they will not cover it under any circumstance. Their policy is not to cover any weight-loss drugs of any type, ever
I will probably go ahead anyway, even though it is ~$1500/mo.
Wegovy website: https://www.wegovy.com/
FDA news Release: https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014
NEJM report on Trial: DOI: 10.1056/NEJMoa2032183
General article: "How a lizard’s venom inspired the promising weight loss drug Wegovy: Semaglutide is the start of a new chapter in obesity treatments." | By Julia Belluz | July 5, 2021
https://www.vox.com/22553793/gila-monster-lizard-venom-inspired-obesity-drug-semaglutide
Have him prescribe Rybelsus (same mechanism) for “pre-diabetes”. Bet they pay for it.
He is a very good doctor, and I really like him, but he is not an endocrinologist. He was not willing to look off label. We discussed it. I respect that and will live with it.
My impression is that most policies are written to specifically exclude "experimental" treatments, and they use non-FDA-approval as a useful (in court) proxy for the definition of "experimental."
Wegovy is not experimental. It is approved for the indication. I linked the FDA press release above.
Well, they also exclude entire categories of treatment, approved or not, e.g. until the angry feminists got ahold of them, they would routinely exclude any infertility treatment from coverage. It does not surprise me that they exclude weight-loss treatment.
Shows you what their real opinion of the obesity epidemic is.
It may, but I think it more likely represents their own internal cost-benefit analysis. On the cost side, if they exclude coverage, then when Sarah the receptionist who weighs 180 in her underwear is refused coverage for whatever treatment she seeks, the rest of the office *may* be horrified, but probably not, and certainly not in the same way they would be if they refused coverage when Sarah's firstborn turned out to need heart surgery to correct a birth defect -- not least of all because at least half the people will probably snort and say Sarah just needs to cut down on the donuts and add some lunchtime walking -- people are generally remarkably and sometimes cruelly unsympathetic to the struggles of the overweight.
And on the benefit side, obesity is one of those things that can have a generally disheartening course, people can struggle with it for years and years, with victories interspersed with setbacks, and the insurance company really doesn't want to be on the hook for something that open-ended.
I think both those reasons are also why they tend to limit coverage of mental health, too. They don't lose much on the PR front by largely not covering it, especially if they throw in 10 appointments/year of counseling, you know, for when your mother and daughter are killed in a car accident and you need to stop drinking or something. And mental health issues are also the kind of thing that can go on for a long time, so they don't like that.
I want to add another point: IMO, Aducanumab isn't shit, it's just that Alzheimer's is really really hard.
Personal background: We spent a couple of lectures in a molecular neuroscience class I took in the spring to review the clinical trials of aducanumab, including the latest trials (EMERGE and something else, iirc), so I dove quite deeply into them.
Aducanumab is not only excellent at doing its direct job - removing amyloid plaques - but also pretty good at reducing secondary biomarkers like amyloid PET signals and ARIAs (small hemorrhages and edemas that show up in an MRI). The problem is with the final proof of slowing cognitive decline, where most cognitive tests in the different trials failed to show statistically significant difference from placebo.
It is also worth noting that amab has an *excellent* safety profile with a wide therapeutic window and few side effects even given the age of the target population.
So what's going on? You can say that amab IS actually completely useless in slowing cognitive decline, but then you need to explain why the different biomarkers, all with well-established connections to neurodegeneration, fail to predict the (non)effect. The amyloid model is not the only one out there, but it's a central one for very good reasons.
Explaining away this connection is not impossible - you can say that by the time these biomarkers are fixed the neurodegeneration is already well underway and irreversible - but it adds a layer of improbability (and would mean that the drug may work as a prophylactic).
What is more likely in my opinion (specifically intuition from what I learned and going over the clinical data) is that Alzheimer's is pretty wide combination of different and very entangled neurodegenerative processes, with different contributions in different patients. Thus, the drug only works well on a subset of patients (maybe, like I mentioned, only those at the very onset of degeneration), but we don't know enough to predict which, so for the entire population of patients you fail to reach significance. Scott shows repeatedly how we see this in psychiatric drugs, which sometimes only barely squeeze by placebo in global trials but doctors have good experience in finding the one that works for a specific patient (and not knowing why).
This approval will mean (a) Biogen, previously on the cusp of failure, now have a lifeline to investigate which kinds of patients the drug is good for, (b) it is released into the market, which means we will soon be getting efficacy data in big numbers, combined with genetic data.
Other avenues are now also more easy to explore - maybe you need combinations with other treatments, maybe the cognitive tests we use aren't the best (it's not like we had a positive control of a perfect treatment to benchmark them against!).
Overall, the scientific advisory committee was absolutely right in saying the clinical evidence is kinda crappy. But the cost-benefit analysis is still heavily in favor of the drug, as it is very safe, molecularly effective, and with no alternatives, in a very widespread and destructive disease. The only cost being some people paying money for a drug that won't help them, and the benefits are huge both short term (for the people which it will help) and long term (for better understanding and getting closer to more global treatments).
In class we placed bets on what would happen. I said the committee will say no, and the FDA won't approve. I've rarely been so glad to be wrong.
Basic Alzheimer's research is pretty insane, with everyone finding new degenative processes (nNOS decoupling and vasocontriction! Tau hyperphosphorylation!) and no one knowing what's actually connected to the cognitive decline and what just comes along for the ride.
Antibody treatments like aducanumab is a shot in the dark, taking one thing in this mess that seems kinda-sorta-consistent - the amyloid plaques - and hoping they stick as a treatment. Not really surprising that their clinical results are this messy. Of course we'll be better off as the basic research slowly advances, there's just the tiny issue of millions of people suffering *right now*.
Strong disagree. There are 10 anti-amyloid drugs that failed clinical trials in the past, some of which succeeded in removing amyloid. There should be a presumption that amyloid reduction does NOT cause a clinical benefit.
Your hypothesis that the drug will help a subsection of patients is plausible, but Biogen had 2 trials to find that group and failed to do so. They had every motivation to. To me, that signals the couldn't find a biologically plausible sub-group that had good results, that they were confident would replicate.
And "final proof of slowing cognitive decline" should be the only thing that matters. I don't care if a AD patient dies with a brain entirely free of amyloid. I (and you and taxpayers and doctors) care about cognitive performance. If Biogen, with billions on the line, couldn't devise a rigorous cognitive test that found evidence of clinical benefit, it isn't there.
The true tragedy of Aduhelm will be that the Alzheimer's Disease research space, which had begun to move away from the amyloid-centric hypothesis, is being effectively redirected to amyloid once again. Research $$ and healthcare $$ will be redirected towards a drug target that has done nothing but fail in clinical trials for 20+ years. The amount of wasted research and pharma money will be mindboggling.
You make a good point with the other clinical trials. My impression (with more the state of the basic science than the details of the other trials, which I admit I haven't dived into as much) is that even with them in mind, the amyloid model still has a lot of promise of being a causal part of the etiology, although I know there's disagreement there (even the instructors in my class strongly disagreed between themselves).
I don't agree that this will divert money and support away from other models. The research space in my impression hasn't so much 'begun to move away from amyloids' as it is 'continuously growing beyond amyloids into anything anyone can think of without really abandoning amyloids, which are still one of the few consistent things'.
Current therapeutic research, though, is kind of 'looking under the lamplight' - we attack the part that we finally we know how (amyloid) than other etiological hypotheses that may be very plausible but currently untreatable. I don't see how approving amab or not changes that. Especially given that it's such a huge potential market that anyone who thinks their non-amyloid treatment can do well on the cognitive tests can easily get support and push forward. My friend works in one such company.
Finally, I get your point about Biogen having had the opportunity to find a treatable population. But looking at the cohort it doesn't seem very selected for anything. So I take it to mean "harder than they expected and therefore hasn't been done yet" rather than "tried and failed so we should abandon".
I think that Alzheimer's and amyloids is kind of like depression and serotonin. Imagine if serotonin was really hard to treat and we didn't have the very lucky serendipity that got us today's drugs. If all we had to go on, like in this case, is a mound of basic research connecting serotonin to depression, and we took it and after a lot of effort (antibody treatments are really hard to get right) managed to rationally design several SRIs that do 'fix' serotonin but fail to squeeze past placebo (considering how close to zero is the global evaluation of SSRIs, with rationally designed ones doing no better than the ones we got by accident, it's not unlikely).
Does it immediately disqualify the entire serotonin hypothesis and any chance that SSRIs can treat depression? No. Instead, we get doctors who are able to match treatment to patient by trial and error, even without knowing why that's the case (which means that the pharma company also can't predict it for their clinical trials).
I think the main difference between this and Alzheimer's treatment history is that amyloid plaque treatment took a *lot* of effort to get right (you're not giving a small molecule that blocks a known protein, you're injecting an antibody - huge, expensive, harder to work with - hoping that whatever immune response it elicits will do the right thing and clear away the plaques).
I should note that yes, it forces us to look deeper into the serotonin hypothesis and realize the etiology is much more complicated than previously thought, just like happens with Alzheimer's and amyloids, but it doesn't completely disqualify the biomarker as a central part of the disease mechanism.
I think one of the Alzheimer's Foundation people made an analogy to the connection between LDL levels and heart disease. It was suspected on epidemiological grounds in the 50s, and a number of drugs were developed in the 60s and 70s that lowered LDL levels but failed to do much to prevent heart disease, and in some cases had excessively evil side effects. Even the first statins had a semi-troubled history, the development of copmactin was stopped after apparently causing tumors in animals, and development of the first statin actually released (lovastatin in 1987) was paused because of that.
It was probably possible, at a number of points in the 70s, for someone to say "look, we've given the interfering with cholesterol synthesis thing a try, and it just hasn't worked, four or five times, so we need to move on, and it's clearly wrong that inhibiting cholesterol synthesis will prevent heart disease." And it's lucky that that is not what happened.
That doesn't mean the hypothesis that clearing amyloid would help with AD is right, or that those who claim it's wrong are themselves wrong, but I do think complex biochemistry -- and the biochemistry of dementia is *really* complex -- is not the kind of thing that lends itself easily to straightforward conclusions.
Some interesting observations, thanks. Maybe I'll go take a closer look at the actual data.
If this were the first time someone had tried amyloid-reduction as a therapy for amyloid diseases, I might be on your side. It's not. This has been tried a lot of times before with identical results - less amyloid, same Alzheimer's. Indeed, even outside Alzheimer's they tried this with Huntington's and got "less amyloid, worse Huntington's" for their trouble (the disease effects of Huntington's are from free huntingtin; the amyloid lumps are the brain's partially-successful attempt to sequester it).
At this point, "amyloid-reduction doesn't do anything helpful" isn't just a null hypothesis but an outright consensus (to the point of satire like this https://blogs.sciencemag.org/pipeline/archives/2018/06/12/an-alzheimers-statement ). Anyone marketing amyloid-reduction without evidence of actual improvement in things we care about is at best irresponsible and at worst an outright fraud.
Your argument seems to read “sure it doesn’t actually treat the disease or benefit the patients taking it, but it treats biomarkers, and that’s what really matters!” But ... why should we care?
> You can say that amab IS actually completely useless in slowing cognitive decline, but then you need to explain why the different biomarkers, all with well-established connections to neurodegeneration, fail to predict the (non)effect
Because changes to part of a system can invalidate correlations you previously observed? Concentrations of a metal ion in urine is correlated with deficiency, but adding more ions to the urine won’t fix it. Liver enzymes in blood are a bio marker of liver damage, but I doubt a transaminase antibody will fix your liver! The marker and treatment endpoint not following each other means the marker failed, and you’re saying it means the endpoint failed.
> Your argument seems to read “sure it doesn’t actually treat the disease or benefit the patients taking it, but it treats biomarkers, and that’s what really matters!” But ... why should we care?
That's a pretty uncharitable reading. I'm not saying the biomarkers are what really matters, I'm saying that given the good effect on the biomarkers and the good research connecting them to the disease means we still have a good shot of finding that it actually does treat the disease (in some subpopulation/treatment regime/tests), even if current tests failed. That we shouldn't throw it out just yet. And this is one of the considerations (safety is another) in the cost-benefit analysis the FDA made.
Yes, this failure at the endpoint is an evidence against the marker, strong even, but it doesn't immediately invalidate all the previous evidence for it, no more than the reverse is true. And Alzheimer's research, like a lot of complex biological processes (think nutrition!), is very messy with new evidence constantly coming up in more directions that doesn't invalidate previous research. It just means the picture is more complicated. Maybe it *is* more like the urine ions in that it just comes along for the ride and not causal, but I think the probability that it's causal is still decent.
Why is there a good chance of finding that it helps treat the disease if the phase IIIs found that it didn’t? “Not throwing it out” doesn’t mean approving it ... even assuming you’re right and there is some point in continuing, shouldn’t you do more trials? I mean one was halted for futility. And adding that to the pile of old Alzheimers drugs with the exact same target that also failed makes it seem even less plausible it’ll actually be helpful.
Why is the hypothesis that amyloid targeting should work but hasn’t yet still the right one? When can we conclude it doesn’t work?
That said, I fully agree that we should uncouple approval and just allow doctors to prescribe it, not force insurance to pay for it. If the cost is "some people have the opportunity to pay for something that might not work" the cost-benefit is tilted one way, if the cost is "everyone has to pay for some people to get this experimental treatment" it leans another.
Even with the therapeutic progress I think this will help us achieve.
I mostly agree with your conclusion that "if you could only LOOSEN or TIGHTEN" FDA approval, loosen is the better choice and in the case of COVID-19, 95% of the FDA's mistakes were erring on the side of stritness.
But I think the story is a lot murkier for the AIDS drugs story than you think, and there is actually very solid evidence Aduhelm /won't/ work given the 10 other anti-amyloid drugs (semagacestat, bapineuzumab, solanezumab, gantenerumab, crenezumab, verubecestat, lanabecestat, atabecestat, umibecestat, & elenbecesta) that have failed clinical trials in the past.
Since that's is a long argument, I'll write it up and post on my substack and then ping you when I'm done, if that's okay.
We stopped doing the Red Scare even though there were presumably still Communist spies in the government so I'm more optimistic than Scott that the War on Terror could be ended.
Terrorists are more easily converted into "think of the children" than Communist spies are. Communist spies are only perceived as a threat to an average citizen if they're actively sabotaging things (in peacetime this is rare) or if the apparent probability of war, the apparent uncertainty of winning a war and the apparent gain from winning a war compared to losing it are *all* high enough that the chain of logic "if enough Communist spies succeed and there is a war, we could lose instead of winning and that would be terrible for my family" doesn't get dismissed at any point (also the person needs to be able to think that far ahead).
There were also more communist sympathizers & fellow-travelers in the government, which was why they were able to recruit such spies. Jihadists have never penetrated our government that highly (places like Pakistan would be another story).
One big difference there is that terrorists self-publicize, and spies don't.
And they have plenty of unaffiliated promotion besides, "if it bleeds it leads" is as true as ever.
I just meant that the whole purpose of their actions is to scare people into doing the thing they want. By its nature, that isn't secret. Conversely, the nature of spying is to stay undetected if you can, so if nobody goes out of their way to find you, they'll never know you existed.
Well, there's also the problem that it's hard to make people care about spying very much, even when it comes out in the open, unless it's included in a much more sinister package. E.g. the Snowden scandal died down very quickly without any policy change whatsoever. With China's pivot to capitalism and the fall of USSR the red bogeyman lost the vast majority of its relevance, these days the agenda is more about union busting and keeping Bernie from being elected.
There were never that many communist spies to begin with, so once people stopped bugging up the problem it faded from public consciousness. But past major terrorist attacks, and occasional minor ones in present and future, mean its something people will always think of as a major issue
Five stars seems like a high bar to clear. While I was reading the article, it occurred to me that a two tier system would probably get most of what was necessary. Approved with warning that risk is high/Approved with high confidence. Do you think that would be good enough?
I think you need a third tier: "Approved with warning that benefits are not yet proven". The two tier system still fails the fish oil test - we can presume that the +fish oil solution (or, to pick another one of Scott's go-to examples, melatonin) would be "approved with warning that risk is high", which would then place it in the same category as, I dunno, highly experimental hail-mary radiotherapy, and leave it all too easy for insurance companies to blanket non-cover the entire category for fear of side effects causing even more payouts down the road.
A category of "we can say that this is about as likely to kill you as anything in the Herbal Remedies aisle of your local Walgreens; though we also cannot say it's going to be any more effective than anything you find in the Soothing Wellfulness aisle of your local homeopathy joint" would at least signal to the insurance providers that these particular treatments aren't likely to affect the almighty bottom line beyond the sticker price of the bottle.
I agree with this post's overall point that the FDA is not, on average, too lax, and that the Atlantic article's take that the aducanumab approval is a sign of them being too lax is a bad take.
That said, I think the beginning of this article really undersells how uniquely bad the aducanumab approval is. It's not just "pretty unclear whether it actually treats Alzheimers." Nobody in the field thinks there's any serious possibility that it treats Alzheimers.
- Here's Derek Lowe talking about it: https://blogs.sciencemag.org/pipeline/archives/2021/06/08/the-aducanumab-approval
- The FDA's advisory committee doesn't think it treats Alzheimers: https://alzheimersnewstoday.com/2020/11/11/fda-committee-votes-aducanumab-trial-data-fail-support-alzhimers-treatment-benefit/
- The trial was halted for futility: https://www.reuters.com/article/us-biogen-alzheimers/biogen-eisai-scrap-alzheimer-drug-trials-idUSKCN1R213G
- The details of the "positive results" are textbook p-hacking of exactly the sort that the whole replication crisis has been about. It's a post-hoc subgroup analysis where the subgroup was selected based on similarity to the patients who had the most positive results; i.e., trivially guaranteed to show "positive" results via group selection. You can read more details in the statistical reviewer's comments in the advisory committee's document (PDF, starting on p. 174): https://www.fda.gov/media/143502/download
- Anecdotally, as someone who used to work in the Alzheimer's research space, nobody in the field seriously thinks the amyloid hypothesis is true. It's been tried, over and over again, every drug that's ever aimed at that mechanism has failed, it's busted.
It's fair to use this Atlantic article as a jumping-off point about how the FDA's approvals system is bad and lots of things get held up there for bad reasons. But I think you're really not engaging with just how bad the aducanumab approval is, and why.
Thanks. I haven't looked into aducanumab too closely and didn't want to sound too sure of something, but I believe you.
In particular it seems like the whole analysis process got sidestepped by FDA leadership - the advisory committee were explicitly told not to consider surrogate markers! See committee member Aaron Kesselheim's resignation letter here https://twitter.com/akesselheim/status/1403675166803169283
Anyone know how to unlock the STAT news articles without paying? I don’t have money :’(((
Great piece. I’m mostly thankful the proposed solutions didn’t involve prediction markets or mitigating AI risk :)
I’d be very skeptical of insurance companies doing any kind of innovation. There’s obviously lots of details but even at a high level we can look at health insurance’s less regulated cousins - like P&C or auto - and it’s not like they’re pricing risk or creating products in a way anywhere near to what you’re hoping might happen. Fundamentally the insurance business thrives on aligning incentives more than it does pricing risk. There’s a lot of hype about the latter but we’re probably 5+ years from that shit becoming real and it won’t be lead by the health product lines.
I actually think you *could* solve this with prediction markets. Actually, it might be a really interesting idea! Thanks!
No! Bad Scott!
Why not?
For one, I thought it was a funny line.
But for two, I think it's seen as too much of a silver bullet in this community. I don't think they'll solve nearly as many problems as some people suppose.
Mother of all conflicts of interest - a company could just bribe all prediction market participants to vote the right way on their drug (either by paying participants or just dumping money in), and then recoup that massive expenditure with the 50k per patient approval revenue. And the market size can’t match that potential revenue for each new drug given the asymmetry of drug development - so many possible drugs and all of them fail. Idk though, maybe it would, im not sure.
Trying to distort a prediction market just subsidizes the people betting the other way.
Which is fine if you get a very high return for it and especially if asymmetries or frictions prevent people betting the other way from efficiently doing so,
Frictions are common, but I'm curious about "asymmetries".
General prediction markers are the worst one here, there are just so many more things that can be predicted than things that should be that you can’t have your whole market reasonably price all or even some of them. Like if you had a prediction market for how likely each person is to have a health risk, or reputation risk, or get or lose a job, that person has a massive advantage over every other market participant in that market, and as such can manipulate it and other participants can’t really stop them
Sure, but sometimes that subsidy can be far cheaper than the current process.
Subsidizing the people betting the other way will attract more people betting the other way... which means you're unlikely to win. Nobody has enough money to buy the pot vs the rest of the world eager to take their money.
If you're trying to bid "George Washington will be elected President in 2024" up to 100%, sure, it'll fail. But if you're taking a drug whose true chances of success are 40% and trying to get it to the magic 51%? You can leave enough noise in the data that it doesn't look like free money to bet against you.
By 2100 the entire global economy will consist of prediction markets betting on prediction markets about what new prediction markets will be formed
I mean, you could argue we’re already half there - futures and options and financial instruments and stuff are already kinda like prediction markets. It’s not as far fetched as it sounds.
Strong agree.
A second-order problem caused by the situation is that, from what I can tell, no one *outside* the FDA has any motivation or bandwidth to think about anything other than “has the FDA approved this.” Pharma companies, doctors, hospitals, etc. aren't making independent judgments about what the evidence says, what risks to take, or how to make tradeoffs. There's no point, because they pretty much have to follow whatever the FDA says, positive or negative.
So instead of a million minds working on any given problem, we only the get the ~10k or so at the FDA.
I don’t think this is true, at least entirely. For instance, several insurers won’t pay for aducanumab. https://www.statnews.com/2021/07/14/this-is-unprecedented-several-private-insurers-wont-cover-biogens-alzheimers-drug/
"The problem was that people might stop trusting the FDA... If you model all FDA/CDC/etc policy as an attempt to avert this outcome, your predictions will be right more often than not."
And on that selected metric, how are they doing?
Do they even track it? Does anyone? Or 'public trust' just a placeholder, a dark matter acknowledgement that the math doesn't add up without some other motive in play... but do things add up with that motive in play?
The gold standard would be a repeated, regular check with stable methodology. There are two obvious recent polls - the Annenberg one in April and July '21, and the RWJ Foundation and Harvard TH Chan School of Health one in March '21. Headlines for them are opposite 'High trust holds steady' vs. 'trust is low'. Neither even attempt to answer how trust compares to 2019, let alone 2009.
It's hard not to wonder whether those hundreds of thousands of lives and 'limitless costs' are buying any public trust, or perhaps even eroding it. After all, the TSA has done wonders to build faith in the War on Terror.
And if the justification for being 'extraordinarily bad' at the job is public trust, and they aren't doing that either... what actually is going on?
The "people" in this case are not the American people, they are the 535 people up on Capitol Hill who set the FDA's budget, and who have the power to make the director's life miserable if they choose.
Now you would think that one of the way you keep a Senator happy is by not failing to approve some treatment that could save 5,000 baby lives a year in his state. But you'd probably usually be wrong. Even if the Senator hears from voters about this, that just means he gets to stand up on his hind legs and solemnly promise A Bipartisan Investigation Into This, and conclude (if the White House is not of his party) that the solution is to elect a President of his party to clean house at the FDA -- click this handy button to donate TODAY -- and (if the White House is of his party) that the solution is to create a new program at the FDA for Avoiding Baby Killing Nonapprovals and boost the budget of the FDA by $50 million to pay for 100 lawyers and 2 MDs to staff it. You'll note that either way the FDA career staff need have no fear of the outcome.
On the other hand, if the FDA approves thalidomide, and the White House belongs to your party, you're really screwed. That's the kind of thing that totally loses elections.
This sounds like a (and don’t get me wrong i hate this shit) messaging problem! Someone needs to figure out his to get all those dead babies on ~~prime time television with Anderson Cooper solemnly narrating a tear jerking sob story~~ nah it’s 2020 find some tiktok stars with family members who got the short end of the approval process roulette and can explain why the memory of their dear and dead father would be best honored by the passage of the conveniently already drafted senate bill 350! If structural problems mean one FDA incentive is inflamed while another is neglected, just make some new structures!
Ideally it wouldn’t be like this, but then again what is this blog doing now if not a less cynical version of the above - if Scott isn’t thinking reform then certainly the hundreds of DC policy people who read this blog and have commented on Twitter about how awful this is are.
We need a wartime FDA and CDC. “First, do no harm (and don’t get sued)” has some issues, but is understandable in “peacetime”. Maintaining that attitude in an actual pandemic is neither understandable nor forgivable.
You're saying we need a War For Drugs as well as on them? Cool.
Nah let’s just trade one for the other.
The difficulty here is that it's always wartime for someone. If my baby was in the hospital slowly starving to death I would be more on wartime footing than I have been the last 18 months.
Official states of emergency are a thing.
Man, reading this so close to bed was a bad idea.
Pretty good article. My favorite FDA story, which may be apocraphyl alas, is that supposedly you can't test combination therapies unless *all* the ingredients are already approved, which means a lot of potential synergies (which we know sometimes exist) will remain unexplored, because one of the components isn't already approved. As in, X did some good for metastatic breast cancer, and Y did a little good but not enough to exceed the standard of care and so didn't get approved -- and now you can't test X + Y to see if it outperforms everything. Boo.
By the way, I think the only legal mechanism by which insurers end up having to cover stuff the FDA approves is tort lawyers. I don't *think* it's built into any statute, although that might have changed under Obamacare, which set new standards for insurance plans. And I also thought whether Medicare covered stuff was decided by the CMS, which in principle is independent of the FDA. But realistically, in the highly litigious, highly suspicious political air in which we live, *everyone* in all those places is in full CYA mode all the time, and the result is what you observe.
I'm very dubious about your proposed reforms being implemented. They remind me of the endless proposals for voting reform proposed by libertarians and other minority parties, which can't be explained in a Tweet unless you have IQ >115 and which therefore uniformly fail (or when they pass, cf. NYC's recent election, just baffle and annoy most people).
There is a far more radical and yet simpler approach, however: get the government out of paying for healthcare directly, eliminate employer tax deductions for healthcare so it stops being a routine employer benefit (and employer choice), and get the government out of the business of setting standards for insurance plans (except insofar as they might mandate outside review of claims, quadrupole damages with executive horsewhipping for strategic or stupid denials).
The point being, if people have to decide for themselves what the cost (literally, in their own precious $$$) and benefits are, history suggests they will be surprisingly canny about that. You want to buy a smartphone, there are a million private resources that will gather all the critical info you need, and people use those things. Even the dumbest among us don't turn up at Home Depot to buy a new washer without having read the reviews. So we would expect the voters and healthcare consumers to become a lot better customers of high-quality information about the relative value of drugs. Whether that information is provided privately or by a government agency might be largely besides the point, if the key criterion -- which is that the information is consumed by, and used by, and important to, the very person who will spend the money and take the drug -- is in place.
> By the way, I think the only legal mechanism by which insurers end up having to cover stuff the FDA approves is tort lawyers. I don't think it's built into any statute
If those tort lawyers win their cases, that means that either
1) if the insurance contract explicitly excludes certain treatments, there is some statute that says that such a clause is unenforceable
2) courts have decided that such a clause is unenforceable even though no statute says so (in which case a statute needs to be made to tell the courts to knock it off)
3) insurance companies don't actually offer such contracts, and they end up having to cover ~everything because the contracts say they have to cover ~everything.
My impression, and I'm not a lawyer, is that insurance contracts routinely exclude "experimental" therapies for conditions treatment of which they otherwise cover, and the legal case revolves around the interpretation of "experimental." The insurance company uses "not approved by the FDA" as a pretty reliable proxy, and if they're deprived of that fig leaf they need to make a much harder case with expert witnesses and so forth.
When the sympathetic jury decides that EvilInsuranceCo needs to cover little Susie's operation because otherwise people will die
https://www.youtube.com/watch?v=eXWhbUUE4ko they can usually find some reason somewhere.
HillaryCare was going to explicitly take away people's ability to sue for non-coverage of care, and it was just one reason (there were plenty!) that it got sunk, because people want everything covered.
I wouldn't be quite that cynical about the American healthcare consumer. I think most people are reasonably OK with a given plan not covering absolutely everything -- as long as they're very clear on what is and what isn't in.
What I think gets their blood boiling, and not unreasonably so, is when they make a good-faith effort to figure out what's in and what's out, and end up screwed over anyway.
For example, most plans cover "emergency care" in the ER at near 100%, or with a very modest copay (like $50-100), although the actual tab can easily be enormous. But what is "emergency care?" It has traditionally been defined as what a reasonably cautious and intelligent layman would *think* is an emergency, e.g. chest pain, bleeding you can't stop at home with pressure, sudden numbness in your limbs, a sky-high fever and violent vomiting.
Recently some bean-counters at UnitedHealthcare had a brilliant idea: hey, how about if we only cover ER care if it's an *actual* emergency, meaning when you get there the chest pain *actually* turns out to be a heart attack and not GERD or a shoulder injury with referred pain to the sternum. We'll save tons *and* discourage people from going to the ER when they could just as well wait until the next morning to see their PCP for an office visit...
As one might imagine, they got a *lot* of blowback about that, with people quite correctly pointing out that some of their customers would actually die for fear of being charged $40,000 for gas pain they thought, being regular schmoes, might've been the MI that killed their fathers -- and haven't we been stressing in PSAs for years that people should NOT wait if they have classic signs of a heart attack of stroke, because time = life?
I believe they've put the rule change in abeyance for now, but that's where they'd like to go, and you can see why it infuriates people. How do *I* know if it's a genuine medical emergency, if I'm not a doctor? Why do I have to roll the dice like that, heads I snuff it through overcaution, tails I'm on the hook for a five-figure bill? Can't you just give me some very clear, easy to read, comprehensible to IQ 90 in a panicked state, definition of what you do and don't cover?
Of course, that doesn't seem to me to be easy as pie, but it does seem likely they could do a better job, if it served their interests to do so. If you ask me, this would be one area where government regulation could improve things at a modest cost, just compelling plans to be much clearer about what's in and what's out, perhaps using the cudgel of requiring any ambiguity to be resolving in the customer's favor.
Oh, I have no doubt insurance companies are untrustworthy. (And hospitals will say "everything is covered" and then the anesthesiologist will send in a $20,000 bill and the hospital will say "well, duh, the anesthesiologist is an independent contractor, you dummy.")
But even good-faith attempts to explicitly say upfront "radical chemotherapy isn't covered" end up getting covered anyway, because it was just one paragraph in a 100-page contract.
Insurance companies should publish machine-readable descriptions of their plan so that anyone can figure out what is and isn't covered.
I'm neither surprised nor upset that their untrustworthy. People in general are untrustworthy, except the few that are your family (usually) and friends (if you pick well). People routine defraud insurance companies, and routinely try to work the healthcare system for all kinds of noxious purposes (drug-seeking, bogus disability). That's just the species we are.
But I do think it would help in general if we spent social effort on just making these kinds of complex deals simpler and clearer. Maybe it isn't that bad of an idea to have some kind of greater standardization of healthcare plans, so people could learn the ropes and take that knowledge with them as they move around and grow older. I do think some kind of government mandate on clarity and published descriptions would help. Maybe some kind of consumer committee that is empowered to compel the company to rewrite its plan descriptions, or submit answers to clarifying questions the committee poses, maybe some kind of legal requirement that the plan maintain a subscriber info 1-800 number staffed by people who can and must answer questions related to coverage clearly and accurately within 24 hours. Not sure -- this is an area of endeavour to which the natural skills of lawyers could be directed, so they stop being pestiferous in other areas.
I did laugh! Although many things, some of which were government mandated infrastructure changes, have significantly reduced road deaths in the past 50 years, and we really should do something about whipped cream.
What's the deal with challenge trials and vaccine approvals? Most of the time I see it discussed with the assumption that challenge trials are currently illegal (but they shouldn't be). But challenge trials definitely aren't categorically illegal, at least not everywhere in the world—several of them have been done for various diseases in the last few years. And even if the US doesn't allow them, there are most likely countries I'd expect to be less squeamish (such as China), but I'm unaware they did them either. More generally, no country started mass vaccination until December, even though China started vaccinating a small number of people in the summer (based on weaker evidence rather than challenge trials).
Are we sure it isn't because it took until December for vaccine manufacturers to build mass production capacity, so faster approval wouldn't have mattered anyway?
Also, why did vaccine manufacturers not produce large amounts once it was pretty sure that their vaccines would be approved, ready to use the moment they were approved? The charts of vaccine doses administered definitely suggest this wasn't the case: they started trickling in December and January, and gradually increased over the next months, rather than starting off with a large jump right after approval. This seems to suggest that production was the bottleneck—although I don't know if the lack of challenge trials delayed when the manufacturers became confident enough that they would get approved to invest in manufacturing capacity.
https://ourworldindata.org/explorers/coronavirus-data-explorer?time=2020-03-01..latest&Metric=Vaccine+doses&Interval=7-day+rolling+average&Relative+to+Population=true&country=USA~OWID_WRL~CHN
Earlier approval would have mattered because the time at which production capacity is built is not fixed. It would not make sense to build a facility that would sit idle, or to produce a lot of vaccines that will just expire before they can be used. And I can't speak for other countries, but where I live in the US the initial administration of vaccines was limited to subsets of the population. expanding over time to permit more people (and even the distribution of those, handled by state governments, left much to be desired).
I recall reading that Bill Gates started funding factories for several vaccines before the trials were finished, so that whichever one panned out we'd have a head start on production.
I read that, too. But it never actually happened. And no one else stepped in.
Pfizer and Moderna vaccines have an (approved) shelf-life of 6 months. Staring manufacturing in September, they could have made a large amount of doses that would have still been usable for 2 months after a December or January approval.
> the initial administration of vaccines was limited to subsets of the population
That shouldn't have limited the number of doses administered. Vaccination was limited to subgroups because vaccines were scarce. With more vaccines, the vaccination of those groups would have been completed faster, and vaccination could have been expanded to larger groups earlier.
Challenge trials in China get you no closer to approval in the US and EU. And challenge trials in the US and EU, while not explicitly barred by statute, are so far outside the norm that you'd pretty much have to develop the procedures and recruit the team from scratch, with opposition from people who consider the concept fundamentally unethical but won't quietly resign when you say that your organization is going to be doing challenge trials this time. Absent strong leadership and commitment of resources from the top, that's going to take enough time that you're not likely to come out ahead of doing the usual sort of clinical trials that the entire industry is already set up for.
As for production capacity, it is remarkably hard to figure out just when Pfizer, Moderna, et al went all in on building mass production capacity, but it is quite plausible that TGGP is right and that they were aiming to ramp up production at about the most optimistic FDA approval date using normal clinical trials. So it is possible, but not certain, that if we'd had a POTUS or an HHS head who could push aggressively for challenge trials, we might have had large-scale vaccine deployment a month or two earlier.
> Challenge trials in China get you no closer to approval in the US and EU.
But they get you closer to approval in China (and likely several other third-world countries, perhaps even in borderline first/third world countries like Hungary).
My point is, if challenge trials would have been useful, I'd expect that China would have done them with Chinese vaccines, for the Chinese people, and perhaps for export to some less strict countries.
I can also imagine that if several third-world countries had successfully suppressed the epidemic starting from last summer using Chinese-tested vaccines, it would have even created considerable public pressure to allow their use even in Western countries. And it would have been a major PR victory for China, showing Western governments as impotent.
Strongly agree with most of this article. Work at a biopharma and it's so annoying how expensive and slow the process for bringing anything to market it. What's most shocking is always how much the doctors and even internal employees internalize the FDA mentality that you'd let 10,000 people die from approval delays vs one person go to the hospital from an unintended side effect. It's not true that insurance companies cover everything. There's some spaces like obesity where they cover next to nothing (I think semalgutide will be different) and very often they won't cover new medications when there is a cheaper older medication esp if it's generic. Lots of times people also need prior authorization for treatments and insurers can just say this isn't serious enough. I think you could see that happen here. The big issue is though that everyone 65+ qualifies for Medicare, most of those people buy Medicare part D (prescription plan) and Medicare does legally have to cover everything at any price because the pharma lobby owns half of the Democrats and every Republican. This means the government will end up paying biogen billions per year. Also since there aren't really any Alzheimer's drugs it's very hard for an insurer to refuse to cover the only treatment available. The issue here though isn't the FDA. It does do an amazing job at getting rid of amyloid and it's safe. In an ideal world we should be okay saying doctors are allowed to prescribe medications that are safe and possibly effective. It's actually quite dystopian to say we should be arresting people or banning them from their professional for giving people treatments that are definitely safe and may be effective. Maybe then we should just stop giving out research grants because not every project is successful. The problem isn't with the FDA it's with doctors and moreso insurance companies being spineless and covering everything which is really a problem with the legal system. No doctor wants to be hung out to dry for not prescribing a well publicized approved medications just because he had some skepticism and then the family goes after you for malpractice and insurance companies can't afford to be evil boogeymen for refusing to pay $50,000 a year for a drug that may not work and even if it did work have very modest benefit. Also the doctor makes money prescribing the drug and the private insurer makes money covering it because minimum MLR ratios mean the only ways to make money are to spend more on patients or cut down on staff, and spending more is really easy! You cut down wasteful hospital and prescription spending? Great job now give everyone a rebate!
> There's some spaces like obesity where they cover next to nothing (I think semalgutide will be different)
To be fair, treating obesity with drugs just seems wrong. There are some very clear dietary interventions that should happen first, and if the state is paying for the obesity drug the state should instead pay a lot less to (on the producer side) implement that dietary restriction.
> In an ideal world we should be okay saying doctors are allowed to prescribe medications that are safe and possibly effective
But it isn’t effective, and we know that. This isn’t the first Alzheimer’s antibody that failed, and it’s not even one of the first thousand treatments that targeted the wrong molecule or protein or function, modified that, but failed out of some large or small misunderstanding or issue
" There are some very clear dietary interventions that should happen first"
I'm unaware of any evidence these work long term for more than a tiny percentage of the population.
Dieting doesn’t work (mostly because people don’t stick to the diets, or modify them). A mandated slicing of added and processes (in the sense of making more isolated and concentrated) sugar and starch and fat as well at the producer level would (carbs are not better than fat and sugar). Might have to ban those delish sugary breakfast muffins and fatty coffee drinks!
You could argue that’s an abuse of govt against freedom, or argue that not doing that is a population scale crime against health and dignity.
The War on Drugs via prohibition failed; the War on Alcohol via prohibition failed badly enough that we don't even call the War on Drugs "prohibition" because it would discredit it. But you think we can win the War on Tasty Food, one of biology's top-two urges, via prohibition?
Sugary food isn’t drugs. The food conglomerates can be regulated in ways that Mexican drug dealers can’t. And it’s not a ban on pizza, just ingredient restrictions, which already exist for other reasons. It’s also significantly reduce like ten of the top public health crises in the country, reduce medical spending and suffering by. Lot, and improve the lives of a hundred million people and save ten million from crippling and painful disease. But I mean, freedom good, government bad, war on drugs bad, regulation is never possible rite
The part your missing is that someone who looses weight through dieting can end up with a metabolism that requires hundreds fewer calories than someone else who hadn’t been heavy. If I modified your gut bacteria to make it more efficient such that you had to eat 700 fewer calories per fat to maintain your weight I’m certain you wouldn’t be able to stick to a diet that would maintain your weight.
Since I can’t edit:
If I modified your gut bacteria to make it more efficient, such that you had to eat 700 fewer calories to maintain your weight, I’m certain you wouldn’t be able to stick to that diet.
I personally easily do stick to whatever diet I want, and have done both significant and extensive fasting and year long very unpleasant dietary changes. Pretty sure I could.
Regardless, all this needs to do is cause people to lose significant weight, which I believe it would (forced dieting does cause weight loss, and this is like that except via the sort of consumer regulation that is standard everywhere). Do you think that this wouldn’t lead to significant improvement in weight for most?
“ Do you think that this wouldn’t lead to significant improvement in weight for most?”
No. People would just eat more bagels and cream cheese and yogurt parfaits.
Also
> It's actually quite dystopian to say we should be arresting people or banning them from their professional for giving people treatments that are definitely safe and may be effective
Why? Is it dystopian that a restaurant can be shut down for serving food with hair in it (hair isn’t harmful...). And IG Farben did SEVERAL studies showing that parathion was ENTIRELY SAFE for human consumption so it is a violation of my dignity as CEO for the pesticide to be banned and deprive millions of poor farmers of their god given right to spray it on their fields, likely putting thousands out of business due to lost crop yields. 1984! Newspeak! Book burning!
Seriously, it’s hard to look at large scale prescription and not think that the FDA regulating medication effectiveness is probably somewhat good because otherwise a lot lot more people would be taking medications that are ineffective but are claimed as effective. That’s what happened pre FDA!
Yes, it is dystopian that a restaurant can be shut down for serving food with hair in it.
LOTS of people take medications that aren't effective and we already have the FDA.
Do you really think that the whole world was buying "Maggie's Snake Oil" prior to the creation of the FDA?
Just like they were all drug addicts before the war on drugs and alcoholics before prohibition and the murder rate was much higher before the first gun control laws.
You imagine a perfect FDA that never was and never will be and compare it to a dystopian past that never was and declare on balance that the FDA is worth it.
What country or city today isn’t a dystopia then
Yeah, but a lot less! And the ones they do take that are useless are often contextually useful but useless in a broader sense, while still bad - as opposed to lead acetate.
Yes, it was pretty bad back then. Medicine also was just a lot less developed, so nobody knew how to tel the difference, but most treatments did not work and those that did not well. Way different.
I’m saying the FDA is better than no FDA or a general assumption that, say, a company’s own trials prove it’s ok to prescribe or docs can in good faith prescribe any synthetic compound if they feel like it
Is there a randomized controlled study that proves the FDA is both safe AND effective?
Your assertion that "the FDA is better than no FDA" is based on wishful thinking and status quo bias.
Are there any randomized controlled trials of randomized controlled trials vs other techniques for establishing safer and effectiveness? And if not, why should I trust a technique that can’t bootstrap itself?
Lol
"anti-freedom lobby" is rich with meaning, and accurately describes at least a couple of my positions. I like it a lot.
The problem with making it so insurance companies can pick and choose what they cover is that health insurance largely stops functioning as *insurance*, unless the optional category only includes treatments way at the margins, in which case it probably doesn’t make much difference. As someone who isn’t a doctor, I have no ability to evaluate a list of treatments and understand what that means for my expected medical experience, because I have no knowledge of what the probability distribution is for health problems I might have in the future (especially once you get beyond high-profile things like cancer). The whole point of insurance is to trade decreased expected value for decreased variance, but unless coverage is approximately everything, I can’t properly evaluate what the variance benefit I’m getting is (but the insurance companies can and will do so to their advantage).
Personally, I think the most long term stable setup is a single provider system like the NHS in the UK, where the organization that sets the standard of care is the same as the one that pays for treatment, because they’re forced to reckon with cost and benefit in one place. This results in some idiosyncratic standards of care (eg, mammograms every 3 years starting at 50 in the UK instead of every year starting at 45 in the US), and obviously they make plenty of mistakes, but overall seems like it results in a workable system.
I'm not sure I understand your first paragraph.
I think right now health insurance barely functions as insurance. Sometimes people talk about a product called "catastrophic insurance" which would cover extremely serious things like cancer, etc, but not your regular checkup. The idea would be that this is pitched at middle class families who could maybe cover $5,000 worth of expenses but not $50,000. AFAIK this is somewhat illegal now, and health insurances have to cover everything including everyday stuff.
If insurances were allowed to choose what level to cover things at, it seems like you could get everything on a spectrum to "we will cover literally every medical expense you have" to "we will only cover the most severe conditions".
It sounds like maybe your concern is that an insurance could say they're not covering, eg, certain expensive conditions, and people who are thinking very short-term might get that insurance because it's cheaper and they figure they'll never get the condition? I think that only makes sense in our current system where you're mandated to get some insurance, and lots of people who don't want insurance just grumble and get the cheapest thing they can. If you actually wanted insurance, for normal insurance protecting-against-extreme-bad-outcomes reasons, wouldn't you not buy something that didn't cover serious conditions?
The problem is that I don’t know enough to adequately evaluate whether any health insurance product actually covers all things that might be expensive if the insurance company is allowed to pick and choose what is covered. I don’t even know the list of things to check. If an insurance company says that they cover these three treatments for skin cancer and these four for heart disease and these two for Alzheimer’s and this one for Parkinson’s, etc, I can’t evaluate the likelihood that that leaves me in the lurch when I have some medical problem without basically going to medical school. The only product I can buy with confidence is one that says “We cover everything reasonable”, and “everything reasonable” has to be defined by some third party because otherwise you have the original problem of the insurance company getting to define it in a way that’s advantageous to them.
I think it’d be fine to have a product that excludes things like checkups or cheap stuff and only covers severe conditions, but when you get to the point of the insurance company getting to select parts of the severe conditions umbrella to cover and not cover others, the buyer can’t accurately evaluate what they’re buying.
> If an insurance company says that they cover these three treatments for skin cancer and these four for heart disease and these two for Alzheimer’s and this one for Parkinson’s, etc, I can’t evaluate the likelihood
Neither can I, but there are lots of consumer-reports-style people out there who will parse it for me.
> Sometimes people talk about a product called "catastrophic insurance" which would cover extremely serious things like cancer, etc, but not your regular checkup...AFAIK this is somewhat illegal now, and health insurances have to cover everything including everyday stuff.
For what it's worth, this used to be a thing in many states, pre-Obamacare. Usually they were the states with the cheapest medical costs by a good margin, as well. Conversely, the state used as a model by Obamacare (Massachusetts) was the second most expensive one.
This isn't very different from the current HSA/high-deductible plan, which is one of the best innovations to accidentally come out of government in decades.
The chief problem with your plan is that if someone decides to buy catastrophic insurance and ends up with something that doesn't meet the criteria for catastrophic but they also can't afford to treat the public doesn't have the balls to let them suffer.
"wouldn't you not buy something that didn't cover serious conditions?"
Again - bad actors. Our insurance covers everything* What have we seen with those christian sharing ministry health insurance scams?
* blah blah blah by everything we mean nothing.
What you didn't read the entire 570 page policy? Well if you did you'd know we don't cover brain tumors. So you only have yourself to blame.
"We'll cover everything that our top-tier insurance covers, but there's a $50,000 annual deductible" seems like a pretty sensible form of catastrophic insurance to me.
$50,000? So if you get MS and the treatment is $50k a year what percentage of Americans do you think could swing that? In these debates about catastrophic insurance the proponents seem to be entirely unaware of expensive chronic conditions.
Fair.
"$50k, or $100k in a 10-year period", perhaps.
What's the median income for a family of 4...$79k. You have mortgage, car payments, gas, utilities, retirement contributions, etc. If the disease was $20k/year where are they going to come up with the money for the first 5 years?
I think this is just re-inventing "pre-existing conditions." It sounds logical in theory - "you need to get insurance before you get sick, not after, and if you didn't get insurance, I guess you didn't care about the risk" but in practice it turned into "I did care about the risk, so I got insurance, but then I lost my job and my coverage lapsed, and my new insurance won't cover my medication because it started under the old insurance company."
The combination of "chronic medical issues exist" and "you can't pay without insurance because of Yagmuk-related pricing shenanigans" means that health insurance doesn't just serve as a risk-manager for catastrophes, but also as the means for buying everyday medical care.
As long as that problem exists, the question of "is insurance providing the right balance of risk tolerance and price?" is going to be impossible because you're not paying for risk management, you're paying for someone who can negotiate to get your bills sent to Yagmuk.
>The idea would be that this is pitched at middle class families who could maybe cover $5,000 worth of expenses but not $50,000. AFAIK this is somewhat illegal now, and health insurances have to cover everything including everyday stuff.
Isn't this just high-deductible health plans? That's what I have. It costs a couple of hundred a month, I use what would have been premiums to fill up an HSA. I think we're 3000 deductible with various co-insurance after that until we hit 5 or 6k, which is our out of pocket max.
It still doesn't make me price discriminate though. There's plenty of cash in the HSA for health costs and it comes off a separate card. I couldn't spend it all in two or three years even if I stopped putting money in, because of the out-of-pocket max, and I've never hit the out-of-pocket max in the three or four years since we switched to it.
As a Brit I wouldn't describe the NHS as offering idiosyncratic standards of care. The true state of the NHS is far worse and I wouldn't recommend anyone adopt it.
Consider that the NHS at this point has essentially collapsed. Nobody is talking about it because the UK is always in a sort of collective state of denial about the NHS, and as an arm of government it has no clear end point in the way a private sector organization would. But measured by any metric other than existence, it has collapsed.
The proximate cause is lockdowns and everything that went with them. The NHS was seriously struggling to handle case load even before COVID but then people were told they had a patriotic duty to NOT go to hospital, and because one of the effects of nationalizing things is a whole lot of people became super emotional about it, lots of people took that order to heart. Also lots of people were told that hospitals are COVID death traps so stayed away for that reason, and finally the NHS implemented a "pingdemic" that caused huge numbers of workers to be told to self-isolate because their phone detected a Bluetooth signal of someone who tested positive. There is now a backlog of delayed treatment so massive that there is no possible way it can ever be cleared except by lots of people dying whilst waiting to be seen. The NHS cannot scale up capacity to treat this backlog for several reasons but one is because there are no market signals anywhere, so the NHS is near-totally unresponsive to changes in demand. Also because of how regulated approval of doctors is and that training is fully state managed, that's also unresponsive, e.g. there's no great way to train "half doctors" who are only capable of treating a subset of problems. There's also been a lot of grade inflation around approval of nurses. As a consequence the NHS is incapable of training the workforce it needs locally and has managed by "raiding" developing countries of their medical staff, on a massive scale. During lockdowns and border closures this way of hiring was shut down, exacerbating the problem.
Another NHS specific problem is that it basically refuses to spend money on capital projects like site upgrades. Whenever it's given money by the government it tends to spend most of it on wage increases even as buildings leak and equipment rots. The problem got so bad and the works backlog so massive that the government tried allocating money with earmarks attached so legally the NHS has to spend it on capital, and even that didn't work, the NHS mostly just ignored the law and spent it on staff anyway. The government can do nothing because the population incorrectly associates "NHS = doctors/nurses" and thus freaks out at any criticism of it, because they think anyone who says the NHS sucks is saying that brave heroic carers suck. So the NHS has become this kind of self-ruling branch of government that is totally unresponsive both to patients and also democratically elected leaders.
"The true state of the NHS is far worse and I wouldn't recommend anyone adopt it."
On the Tube you see tons of ads for supplemental insurance that gets you access to among other things HCA units in NHS hospitals and independant HCA and other non-HCA hospitals. (HCA - Hospital Corporation of America.) The cost of these policies is fairly minium I think they start at something like $50/month. The vast majority of brits don't bother to buy one. If things were as bad as you say that wouldn't be the case.
I guess there's a couple of issues there.
Firstly, BUPA alone has 2.2 million customers for their private insurance in the UK. Private health insurance isn't that rare, even though it's not talked about much.
Still. One reason low relatively low uptake is that private health care isn't hugely useful in the UK, because the NHS squeezes out most of the competition leaving private hospitals to compete mostly on quality of care issues, and that in turn throttles private hospitals - they actually can't handle quite a lot of the most complex and difficult surgeries, because they can't compete with "free".
Except of course, by offering lower waiting times. Whilst the NHS has had various waiting time crises in the past, they eventually attracted political attention and been resolved (sometimes at the cost of creating new problems elsewhere). But they've never reached the staggering scale they now have done. Perhaps the situation w.r.t. private healthcare adoption will change? If you're seeing lots of ads, apparently some insurance firms are anticipating increased demand. I never used to see many ads for private healthcare when in the UK.
The final issue is the previously mentioned quasi-religious aspect of the NHS. It's scarily irrational. Try having a conversation about the best private health insurance in a mixed group of Brits, say it's because you don't think the NHS is good enough and see what happens. The NHS is often called the "national religion" because too many people act like criticism of the NHS is criticism of an actual god. Any private firm would struggle to compete against a fully tax funded state run organization, but when you add in that aspect, it's amazing there are any private hospitals at all.
"Still. One reason low relatively low uptake is that private health care isn't hugely useful in the UK, because the NHS squeezes out most of the competition leaving private hospitals to compete mostly on quality of care issues, and that in turn throttles private hospitals - they actually can't handle quite a lot of the most complex and difficult surgeries, because they can't compete with "free"."
That summarises to "NHS good". You have admitted that they can do complex stuff that the private sector can't, so that's one version of "good" , and that they ar cheap , do they squeeze the private sector on price , which is another version of "good". Would that the US had some force pulling down healthcare costs!
The private sector *could* do it obviously, they're all recruiting the same staff.
The NHS is not cheap, it's taxpayer funded, which isn't the same thing. The closest model is if the government picked a single company that both runs hospitals and runs its own insurance scheme, then forces everyone to become a customer whether they want to or not. That company would immediately become very stagnant and bad at its job, and most people would still use it anyway because going to a competitor can only increase their costs but never decrease them.
The UK spends half as much aon healthcare as the US for similar results. So the NHS is cheap, by empirical evidence. Your argument that it must be bloated and inefficient is a priori.
Maybe we just need FDA Pre (analogously to TSA Pre) to grant people who are background checked and have given informed consent access to unapproved drugs?
Science-Based Medicine _tore_ into aducanumab.
https://sciencebasedmedicine.org/fdas-decision-to-approve-aduhelm-aducanumab-for-alzheimers/
At least doing so wouldn't be as laughable as some other things SBM has gotten up to recently: https://jessesingal.substack.com/p/science-based-medicines-coverage
I find it interesting how your proposed 1-3 star rankings look a lot like phase 1-3 in the approval process. So if you compare this to what we have now, the major changes are:
a) Doctors who are expert in a specific field can approve drugs after only a phase 2 trial,
b) Drug companies can't advertise a drug until it's been in the field long enough to get 4*, and
c) Insurance companies are obligated to pay for far less stuff.
This is both wise policy, and the single least popular package of reforms I can imagine which would fit in a single tweet.
Agree with almost all of this, except (somewhat predictably) some of the COVID related stuff.
The small number of apparently honest that look at the NPIs all conclude that none of them correlate with outcomes at all. That includes contact tracing. The only human action that seems to have any effect is vaccines, and even then, only on severe outcomes, not on transmission or mild infection. You assert that Taiwan is a success case for aggressive contact tracing, but in reality they ended up having a recent outbreak anyway and it's really not clear what causes the different time series between countries. Taiwan in particular only seems to test very ill people, as evidenced by their sky-high CFR compared to other countries, and up until recently was basically not testing at all. Everyone likes to read a pet theory into the timeline of a few countries, but these always seem to break down when analyzed against the whole dataset.
The FDA's concern that uncalibrated tests can lead to false positives is at least a genuine one. PCR tests are often claimed to have no false positives, but in reality they can have extremely high FP rates. Medical "science" has fixed this by defining COVID as having received a positive test, which is why they normally claim the tests don't have false positives (gotta love circular logic). E.g. one study found that in 70% of PCR positive samples it was impossible to culture the virus, implying there was no viable virus in the sample and thus that the lucky winner of the positive test wasn't infectious.
FPs have real consequences. Not only the obvious one of confining harmless people to their homes, wrecking travel plans etc, but also by contributing to the rapid degradation of trust in institutions. When scientists claim the tests have no false positives and then make claims on the back of this idea (like calculating re-infection rates based on the assumption that two positives cannot possibly be one true and one false), it worsens people's trust in all science. Lab challenge programmes in pre-COVID times have shown PCR testing to have anywhere between 1% and 15% FP rates, and lab challenges can be done by literally anyone who submits a sample to a PCR lab using a home testing kit. There are or were lots of videos circulating on social media of people who swabbed a puddle, their dogs ass, or nothing at all and then getting back a positive result. Not surprisingly people when people then ask, "well what's the true FP rate?" they discover that governments and scientists are claiming there are none. This leads inevitably to conspiratorial thinking, or at the very least, a sudden willingness to question all medical authority. Exactly what the FDA is trying to avoid.
Does that justify the FDA's stance? No. It would be better if the FDA was privatized and became a charity or something, using kitemarks+trademark law to grant approval of treatments. They've made tons of mistakes. But the underlying problem they were trying to avoid is now biting society on the ass.
> The only human action that seems to have any effect is vaccines, and even then, only on severe outcomes, not on transmission or mild infection.
Bluntly, this is nonsensical. Look at how fast cases fell, even as countries re-opened.
Heck, even NPIs can clearly work, insofar as the population actually does them. The whole "wave" structure was 100% based on the fact that people loosened up when cases were low and clamped down when they were high. That tells me that clamping down is effective, even if a governmental Official Clamp-Down Mandate might not be.
I don't quite follow your argument. Yes, cases fell even as countries re-opened, rather implying the restrictions weren't working, right? Hence the recent blowup in the UK where "experts" said ending restrictions was an unethical expert on the entire world and there'd be hundreds of thousands of cases, and then cases dropped off a cliff. If the restrictions were really keeping cases in check that couldn't have happened, but it did.
Cases fell as countries re-opened *during the period where vaccines were being given out en masse*. That means vaccines work better at limiting spread than lockdowns, but it doesn't say anything about lockdown effectiveness per se. (I tend to think the mandates did relatively little, but this isn't much evidence of that by itself.)
Maybe again I don't quite follow your argument. Can you please lay out again the chain of logic you're using because it just seems totally wrong on its face.
Go to Google and enter "uk covid" to pull up case and vaccination curves. They're embedded right in the search results page.
The UK's most recent wave started on about 20th May. At that point 56% of the population was vaccinated with at least one does and about a third with two doses. Vaccination was proceeding apace. A month later those figures were 64% and 47% respectively. The summer wave peaked around 21st July, almost exactly 8 weeks after it started. "Freedom day" was on the 19th July. Literally, two days after the restrictions were released cases started falling, in flat contradiction of apparently every expert prediction. There was an open letter signed by 1200 "experts" stating that cases would explode once restrictions were removed. Every single one of them was dead wrong and wrong in the wrong direction.
If this event cannot falsify your belief in lockdowns then I'm really curious what could?
There's a few distinct things happening, and the sequence differs between different countries. This does, admittedly, make the results a bit messy.
1) Public worry at the high case counts of last winter, lowering transmission.
2) Mass vaccination, lowering transmission.
3) Delta, increasing transmission.
4) Reopening, increasing transmission.
All of these will affect case counts in various ways. My claim is that #2 and #3 are the big ones, and #1 and #4 have relatively less to do with the changes we've seen in the last 5-6 months. In countries that vaccinated first, like Israel, we saw cases plummet, even as things reopened and the public was clearly loosening up. However, Delta came along soon after and reversed that progress (at least, re: case counts - serious illness is still pretty low). Indeed, some countries that had kept things well controlled for the first year saw their control systems break in dealing with Delta, because those countries were often very slow to vaccinate.
I confess that I haven't looked at this UK case in any detail. However, note that I think official government lockdowns are largely ineffective, because what actually matters is how people act, not what governments order. We don't live in police states, and I'm not convinced that those orders are complied with very much - the people who'd lock down anyway are locking down, the people who wouldn't aren't.
There's at least one other possibility that fits your data and assumptions: COVID transmits very easily, is largely invisible for most people (asymptomatic or just minor cold/flu like symptoms), and most people don't get tested such that we never knew they had COVID in the first place.
In this case, vaccination works along side a very high immunity from having already contracted and recovered. The effectiveness of the vaccine apart from having already had COVID is a little hard to disentangle since we don't know how many people had antibodies already before they got the vaccine, but the vaccine helps in either case.
Countries that locked down more saw less growth in COVID cases, partially because locking down worked and fewer people got it and got tested, but also because people who had minor cases figured "Just the flu, couldn't be COVID because I am locked down," or just couldn't get tested one way or the other because doctor's offices were locked down. (That was the case in PA, strangely.)
Downside of locking down, the slower growth in cases meant there was a longer store of fresh meat for the virus to infect, so cases kept popping up, stretched out over time. We rationed COVID's food source and made it last longer, in a sense.
Delta comes along and gets around immunity, whether from vaccine or recovery, but a bit less than if you have neither.
Now, if recovery works better at staving off Delta than the vaccine, then places with more initial mild infections are going to do better vs Delta than places with fewer, controlling for vaccination rate.
If we are testing a lot more, we are also going to find a lot more cases, but if transmission is very high of COVID-Classic we should expect to see more variants in the new cases in places that were more open and have fewer vaccinated. Comparing those places to more open but more vaccinated might give us an idea how many stealth COVID-Classic cases there actually were.
Of course, we should also be controlling for how many people come in and out of a country, since they are certainly not closed systems and travelers can transport different subvariants between them.
It is a mess, with lots of causal density and very different outcomes based on which set of plausible assumptions you like, it what I am saying.
You don't have to live in a police state to gave compliance. The low compliance of the US is an exception , not a rule.
You're looking at combination of reopening and vaccination. If you look at the UK data from 2020, cases fall during lockdown and rise after release. Similarly for a lot of other countries.
Actually in the UK 2020 waves, cases began to fall a few days before lockdowns could have had any effect (according to the serial interval being assumed by modellers at the time, at any rate). This got noticed a bunch of times but was ignored, like always.
But I'm not sure going around the lockdown merry-go-round again is a great use of time. UK Freedom Day, Sweden, Florida, Texas, South Dakota, the list of places and events that show lockdowns were having no effect is a lot larger than one, which is all that's actually needed to falsify this theory. To me it is 100% clear and obvious that lockdowns have had zero effect, and it still baffles me that people manage to conclude otherwise. Remember: lockdown theory is total. It has no exceptions. To disprove it all you need is one place and one time where removing a lockdown wasn't followed by an immediate (~few days later) increase in cases, or one time where adding it wasn't followed by an immediate drop. That's it: just one. The rest is gravy.
" To me it is 100% clear and obvious that lockdowns have had zero effect, and it still baffles me that people manage to conclude otherwise."
Am I correct that your assertion is that voluntary behavior changes had an effect but the subsequent official lockdown had no effect? Or is your assertion that both voluntary behaviour changes and official lockdowns had no effect?
The latter. I can see what you're arguing - basically that law changes didn't change how people behave, and thus reality has been a perma-lockdown that therefore cannot be seen in any data except right at the start. But the existence of places where the population took a way more relaxed approach and which had average outcomes, seems to speak against this. Or it jus becomes unfalsifiable and you say, whatever people were doing it was "lockdown" and thus cannot be seen in the data because it never ended or changed in strength.
The Ancient GeekWrites RationalityDoneRight ·1 min ago
"Actually in the UK 2020 waves, cases began to fall a few days before lockdowns could have had any effect,"
What's your idea of the causal mechanism behind that? My idea is that people engage in lockdown like behaviour -- voluntarily staying indoors and masking-- before lockdown orders are issued. Which mean "lockdowns work" is true , inasmuch as it refers to behaviour on the ground.
What alternative mechanism would cause cases to decline just before a lockdown order?
If waves are caused by mutations giving the virus a foothold in a small subset of the population that is vulnerable to whatever the mutation does, then the wave will peak once that small subset has been infected and recovered, restoring herd immunity.
Epidemiological models have no concept of this because they assume 100% of the population is 100% vulnerable to any "novel" virus. If you start asking questions about how they define "novel" and what makes SARS-CoV-2 "novel" and not, say, merely a variant on pre-existing coronaviruses as the name actually implies, then you'll discover there's nothing there. There's no microbiology in epidemiology. They have no way to measure the similarity of viruses so they just assume every virus is maximally new, and every person maximally and identically vulnerable, which is why they are constantly predicting staggering numbers of cases in a single massive wave, and then looking stupid when reality does something very different.
Saying the Taiwan case doesn't count because of a small recent surge is ridiculous. You can just look at the death rates over time and see they were much lower. Despite being one of the first countries exposed
Yes, but how do you know that was caused by contact tracing specifically? The problem is, there can be many different causes for these things. To study the impact of any one intervention, you need to look for some sort of correlation across all countries and the only one anyone can find is vaccines. Taiwan having a surge anyway despite doing the same contact-tracing as before is just one data point.
Most NPIs aren't especially effective, but I don't think that includes contact tracing in a situation where the spread is low enough that it's viable. Multiple countries have done that, but I don't think they're usually included in studies of NPIs precisely because there's so little COVID there (and thus don't seem like useful comparisons for countries that have many spreaders).
"Then they approved a CDC kit which that the CDC could send to places other than their headquarters, but this kit contained a defective component and returned “positive” every time. The defective component was easy to replace, but if you used your own copy like a cowboy then the test wouldn’t be FDA-approved anymore and you could lose your license for administering it."
It's actually worse than that. The CDC developed a three part test. The first two parts looked for two difference parts of the known Covid genome. The third part tried to detect if the virus was mutating. It was this third part that was the really broken one and always said yes. Also some of the tests had a faulty second part. But the first part, which would detect the virus just fine but wouldn't provide information about mutation worked for everybody. In theory hospitals could have just used that first part and gone about their business, that would have been just as good as the tests the South Koreans were using to control the virus. But that wouldn't have been using the kits according to the approved instructions and thus in an unapproved way.
coincidentally, I just had a conversation with coworkers in the hospital today, and when I mentioned that I donated to the most efficient charity according to GiveWell metrics. My coworkers universally denounced the fact that I was trying to do the most good with my money and accused me of paying too much attention to money, also gave me a whole spiel about how it's evil to want more people to live and/or for longer. Like they have no concept of doing good with money. Never before have I felt so alienated from those people. I used to think they were basically decent human beings, now they were just like aliens speaking nonsense. I am so sad.
But like with people like that I can see how this system gets built.
They aren’t not “decent human beings”. Most people have evil, despicable, and truly vile beliefs and actions. And those coexist with the good ones. Given that charity donation is relatively abstract, especially EA stuff is still novel, I don’t think rejecting that is that bad. Kinda hard to understand what issue they’d have with it though (evil? Is this like a conservative “poor people need personal responsibility” thing? How is “paying attention to money” bad?) but that is extremely benign relative to a lot of other stuff
I've noticed that "paying attention to money is bad and you should feel bad" is commonly expressed in my lower-income circles and almost never in higher-income ones, which makes me think it's an internalized form of sour grapes?
Hating the human race seems to have become normalized. While I think that on one level it's just talk, on another level it's the sort of just talk which indicates some sort of a problem.
It sounds like that really affected you. Possibly you've grown used to talking about these ideas with people who are familiar with them and have adopted a certain ethical aesthetic. But it's pretty outside of the norm to view moral decisions in a calculated manner. Before judging your coworkers as evil, I would ask yourself whether you really think they gave the idea a chance before rejecting it, and if they didn't whether that had anything to do with its presentation. It's tough to hammer home the point that money = time = effect, and that the types of suffering that EA targets aren't just abstract years but tangible pain and agony.
Another reason people don't like to consider this argument is that accepting it can lead to a lot of guilt. Once again, it's a matter of presentation to show people it's more an opportunity to do good than a criticism of past actions.
>it's pretty outside of the norm to view moral decisions in a calculated manner
Because once you start measuring moral and practical decisions with the same currency the calculation will cash out very quickly to you being a giant hypocrite. Most people aren't ready and/or willing to deal with the resulting cognitive dissonance, an thus keep those magisteria very very separate.
I don't think that's it. Quite a lot of people think of money as being some grubby capitalist token, which mostly gets used to cheat and steal. It doesn't scan as "resources" to most.
It'd be like looking for cost-effectiveness in a spouse. Merely asking the question would weird out 95% of people.
Well, some of this is probably an innate resistance to Goodharting, which is healthy and rational. It's humanly impossible to make an accurate cost/benefit calculation for the vast majority of complex practical problems, which is something that the EA movement acknowledges, if quietly.
I don't know your co-workers but with the situation you describe, I imagine it is more likely that this was a knee jerk reaction to feeling like you were putting on airs.
I think it is similar to how people respond to veganism a lot of the time, getting very conspicuously upset at other people for being vegan.
I see two different base level objections. First talking about EA and GiveWell might, to them, feel like you are saying "See I am actually a good person, and you are not a good person because you don't give to charity, or give to shit charities that don't do anything", so they get angry and rail against the idea even if they do not actually have any real objections to it. Second they might just object in the abstract to equating human lives with money spent in some squishy monkey morality kind of way without actually grokking the broader conversation. Which is why a seemingly normal person can suddenly be found arguing against saving lives.
Not that there are no real objections to EA(or veganism), I just think that the situation I described would also be common.
Is it just conceivably possible that you mentioned this in such a way that it came across as "Well *you* are all stupider than the dumb beasts of the field, giving your money away to any sob-story, but *I* am Really Smart and have found the Maximum Way To Do Good? Such a shame you can't be like me!"
Because sure, all your co-workers *could* be evil, heartless aliens. Or maybe *you* sounded like a jerk?
I get the sense that specific possibility has never once crossed Sortale's mind.
It's very easy to come across as holier-than-thou, I've stumbled over that myself once or twice. Phrasing it as 'best value for money' without explaining exactly what is meant by that can sound like 'only caring about money, not the people suffering'.
If I donate to a kidney foundation because my aunt Mabel died of kidney problems, someone lecturing me that really I should be giving all my money instead to mosquito nets does sound like "caring more about money than people". Oh you're telling me to ignore the people I know right here, right now, with this illness in favour of strangers thousand miles away? Where do you get off?
> My coworkers universally denounced the fact that I was trying to do the most good with my money and accused me of paying too much attention to money, also gave me a whole spiel about how it's evil to want more people to live and/or for longer.
I bet that's exactly how they put it, too. While twirling their moustaches and going "mwa ha ha".
No, more likely they told you to focus on charities who address the most pressing problems, or who are based locally, or something -- as opposed to putting your entire faith into one dubious organization's ranking chart. In other words, they said, "consider using heuristics A, B, and C as opposed to just Z", and you went all, "no, Z is the One True Heuristic and everyone who disagrees with it is evil". Who exactly is the alien in this picture ?
Shame...normally I really like the Atlantic. I hope all their other reporting isn't like this and I just didn't notice it.
I don't know any more than you about the Atlantic in particular, but I will say... every time I've found myself thinking something like this about a journalistic institution or source of information on the Internet, I've ended up concluding with time that the incident wasn't isolated and the bias was pervasive. Listen to your instincts
I don't think it's literally _all_ of their other reporting, or all of reporting in general, but a LOT of it really isn't particularly good in lots of ways. It can be very frustrating reading most 'journalism' or reporting (or anything) once you've noticed this kind of thing often enough!
For subjects or topics NOT subject to strong 'information cascades', i.e. where 'reporters' mostly repeat each other, you can sometimes kind of 'triangulate' based on a number of different published works.
I personally think it's better (tho maybe not by much) to try to read and follow the work of particular individuals that seem relatively well informed (and insightful, and honest).
I also try to _think_ of things I read as 'X happened, as reported by Y, and according to Z' – and to reference those things in the same way. Repeatedly emphasizing, mainly to myself, that these are _claims_, and thus chains or networks of (fuzzy) indirect inferences, helps me remember how weak a lot of what I read is as evidence of anything in particular. Sometimes it seems (to me anyways) like a lot of (roughly) independent weak evidence is, in aggregate, pretty strong evidence of something, but it's generally pretty tricky!
But yeah, Gell-Mann Amnesia is an epistemological nightmare.
As a rule, journalism in any field you know very well, as a professional, will enrage you, so as long as you stay away from articles that talk about any subject on which you are personally an expert, you'll be fine.
"Fine" maybe in the sense of not being upset!
I do love any 'inside baseball' from basically any field or topic or whatever tho; they're all uniquely fascinating in the same kind of way (if that makes sense).
I find there's three kinds of writing I see on my area of professional expertise.
1) Dreck. (This is where Gell-Mann amnesia is born)
2) Things written for an audience of actual professionals. (This stuff is really good, as a rule, if you can follow it)
3) Occasional writing aimed at a lay audience, though usually the dorkier end of it, by people who know their beat. Usually the author has professional experience in the field, or at least many decades of writing on the topic. For my field (finance), Matt Levine is the best example I've seen - anyone who knows finance at a r/wallstreetbets level can follow that quite well, but it is clearly written with a deep understanding of the industry, and it shows in how it's written.
The decline of #3 as a journalism school is very sad.
It probably is, especially when not written by experts. It's Gell-Mann amnesia.
"(T)he long-term solution is to become a different kind of country and different sorts of people"
I know I'm preaching to the choir here, but we will never become that sort of country/people until the people that are start having meaningful interpersonal relationships with the people that aren't.
Brutal twitter owns (assuming that the owner/ownee relationship is not, in fact, inverted) seem to be moving the needle the other direction.
So what's the causal mechanism between "have drinks with trump supporter" and "better understanding of medical issues"?
Trust.
One of the big issues with extremists, on all sides, is that they do not trust people who differ from them too much. They get very suspicious, and assume that everything The Other does is some big conspiracy to screw Our Team over.
Show them that The Other is human, cares about many of the same things Our Team does, and really is trying to make things better, and this state of affairs can be improved somewhat.
Then I'll just ask you for this - quit calling them "lies", and start calling them "confirmation bias". It's more accurate, because most of them were not consciously aiming to deceive.
If you're talking about a handful of people at some agency somewhere, sure, maybe those were lies. (Maybe not - they could well have believed it and thought of themselves as true whistleblowers - but a small group lying is at least plausible).
But the Russian complaints you saw on social media? Those were honest confirmation bias. You can't coordinate that many millions in a lie.
I’m an extremist and I converse with everyone. It’s only made me more extreme.
The nazis were also human and cared deeply and powerfully for their family and brethren and didn’t differ so much from you and me and had the ineffable soul of human development and overcoming. And so do FDA panelists! And so do murder rapists and Monsanto execs and researchers and many sjw woke academics. This does not stop them from doing really bad stuff, and doesn’t stop some of them from needing to be removed from power and discredited.
Talking to people you don’t like is very important, but more so that you can understand them and oppose and develop said ideas, not just to agree with
Oh, for sure. I'm not saying that you need to agree with them. Just that it's sometimes effective at sanding off their rough edges.
And yet Daryl Davis has personally convinced a lot of 'extremists' to give up their extremism, and to even publicly disavow it, and the experience of Megan Phelps too, seem to be pretty good evidence that something like 'exposure therapy', where 'extremists' are exposed to their 'enemies' and then change their mind about those enemies being terrible monsters.
I agree that this doesn't actually stop anyone and everyone from "doing really bad stuff" – one reason being that lots of otherwise okay people do 'bad stuff' and another being that there are no perfect arguments capable of convincing anyone of not doing bad stuff (and yet another being that it's not obvious – to everyone – which stuff it is exactly that's bad).
But I'm guessing you're not – or don't think of yourself – as being an 'extremist' in the sense of someone willing to do (or having already done) "really bad stuff".
I fully endorse having detailed and complex conversations with enemies like Daryl does. However, the enemy often wins those. And then you become the enemy. So still do it, but the point is to understand the enemy, and maybe they were right!
I think Daryl's 'won' most of his conversations, and he definitely hasn't "become the enemy" (from his own perspective), tho he's definitely admitted to NOT winning over some of the 'enemy'.
But I really respect that he started it all _because_ he wanted to understand those people.
100% agree with Alsadius. And would also add maybe "have drinks with trump supporter" the wrong place to start/way to think of this.
Because, if my circle of acquaintances is typical of Republican fare, the average Trump *voter* (i.e. voted straight Republican in the last 4 elections and doesn't care who it is as long as it isn't a Democrat) is probably not a Trump *supporter* (i.e. bought the MAGA bumper-sticker/yard-sign/t-shirt discount combo). So maybe instead of trying to befriend the MAGA hat at your local pub, a better action would be to have lunch with your conservative-but-not-all-about-Trump relative/coworker and having a more meaningful conversation that will hopefully eventually have knock-on effects with their even more conservative friends and relations who wouldn't even listen to you.
And I realize that if you don't live in a Red Tribe locale it may seem from a distance that the Republican party is all about Trump, but again if my experience isn't an anomaly then such is not the case.
And I also realize that's a lot of work for at best a very slow payoff. But I can also say with certainty that shame has *failed utterly* as a strategy to combat the problems of today. It has instead auto-catalyzed an oppositional force. Twitter is not going to solve this. Or to put it slightly differently, the Republican party may or may not have been racist before, but as soon as race became a tribe-defining political issue it became inevitable that they will become more so over time.
More people voted for Trump losing effort in the last US election than voted for any winner in US history (including himself in 2016, I'll reiterate: *more* people voted for him in 2020).
There's a lot of them, they aren't going away, and you can't politically defeat them except in a very temporary sense. So that leaves persuasion and compromise.
I propose that college professors be allowed to take whatever drugs they want so long as the drugs won't get them high, and the professors agree to waive medical privacy and fully report the effects of the drugs. This proposal might be politically practical because the left would mostly trust professors to make the right decisions, and the right mostly wouldn't care if professors harmed themselves by taking dangerous drugs.
Something like a minimum IQ would-have-been-banned store: https://www.overcomingbias.com/2007/03/paternalism_is_.html
http://mason.gmu.edu/~rhanson/wouldhavebanned.html
I suspect if drug approval rules were relaxed to a large extent, along with all the good drugs would come a tidal wave of absolutely terrible ones that’d harm a lot of people. And that the severe regulatory regime correctly suppressed a lot of those second ones right now, so the scale of the problem is not visible, and to understand that one should probably think of medical history pre FDa, while it also wrongly suppresses a bunch of good stuff, which is then visible.
The question is whether that harm would outweigh the harm caused by delaying lifesaving vaccines.
Yeah. Also might need to consider bad medications might decrease use of good medications that treat the same thing. The point is that the harm caused by FDA is more obvious than the harm caused by less FDA because the second is a century removed
> a tidal wave of absolutely terrible ones [drugs] that’d harm a lot of people
Do you mean 'positively' harm, i.e. the 'terrible drugs' would themselves directly cause harm?
As-is, there already seems to be a 'constant (Biblical) flood' of 'terrible health interventions' that harm a lot of people – relative to those people getting or receiving objectively efficacious health interventions.
I'm also skeptical that "medical history pre-FDA", or food safety pre-FDA, was as terrible as you seem to be assuming. I think a lot of the specific motivating examples purporting to demonstrate how terrible medicine or health care, and food safety, were pre-FDA are now thought to be either wholly fabricated or grossly exaggerated. I think it's hard to think of either as being particularly dangerous – relative to all of the other dangers to which people are vulnerable.
And it's not the case that the only two possibilities are 'the FDA exactly as it is now' or 'no FDA at all' (let alone 'exactly as it was before there was an FDA').
Yes I do mean positively harm. Replacement harm by ignoring other treatments is also a concern, but positive harm was what I meant.
> As-is, there already seems to be a 'constant (Biblical) flood' of 'terrible health interventions' that harm a lot of people – relative to those people getting or receiving objectively efficacious health interventions
Is there? There are a lot of bad health interventions, but there are a lot less than good ones. A lot especially are in the category of “contextually do prevent death, but something like diet or environment changing would be better”, but that’s not really a thing the FDA can do much about.
There’s a whole raft of drugs that were claimed by the developing company to be very good and awesome, but the FDA shot down, and then ended up being useless. This is still a problem now, see biased trials from the company and such, but the FDA’s restrictions seem to help restrain that a lot. You can see this with how many late stage drug trials fail, and how many companies really want them not to. If some could just ignore that or twist the data, why not?
In practice without the FDA probably bad stuff would happen and then you’d get a new FDA.
And yeah, obviously the current FDA sucks. Reform good! I’ve seen a lot of actual calls to abolish the FDA though, which seems bad.
It's definitely hard to know how to 'count' health interventions – as individual classes or categories of intervention or per-intervention (and weighted by some kind of severity of the underlying condition attempting to be treated)?
But my understanding is that, even of the "good ones", most health care ('health interventions') probably don't work, beyond perhaps placebo effects. Antibiotics definitely _can_ be extremely efficacious, but how often are they, in practice, given, e.g. being routinely prescribed for not-obviously-serious-and-obviously-bacterial infections?
> In practice without the FDA probably bad stuff would happen and then you’d get a new FDA.
I agree that this is, sadly, true.
> I’ve seen a lot of actual calls to abolish the FDA though, which seems bad.
I'm not so sure it would definitely even be bad, were the FDA to be abolished. I think lots of people are already, now, extremely skeptical of drugs generally, and definitely of pharmaceutical companies. And lots of people (sometimes different people from the previous group, but sometimes the same) are also really enthusiastic about treatments, and even drugs, that either probably don't work or probably would harm them.
And, in my mind, the 'background context' of all of this is knowing that millions of people buy and sell and use drugs that are not only not approved by the FDA, but illegal and for which draconian prohibition is actively and aggressively enforced (however poorly or incompletely).
I'm much more sanguine that (some) people would develop their own (better) alternatives to the FDA were it to be abolished (and drug testing itself wasn't illegal).
Appreciate this summary, Scott; oft thought, ne'er so we'll expressed. Also appreciate the Piers Anthony homage in the title (if I've guessed right) and the fact that you appear to have attracted at least one person formerly shortlisted for FDA head to the comments.
This is by far my favorite ACX article until now
Mine too. Somehow manages to be hard-hitting and hilarious at the same time. Wonderful.
I wish you would do an article regarding the deaths associated with the vaccine itself.
The UK reports 466 deaths from the Pfizer vaccine alone ( see total on last page ):
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1007272/Pfizer_DAP.pdf
Close to 12,000 deaths from the vaccines in the United States
https://www.medalerts.org/vaersdb/findfield.php
CDC reports 6,340 deaths from the vaccine
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html
A US patent was just awarded to a Finish for a nasal spray drug that includes Hydroxychloroquine & Ivermectin. Any thoughts?
https://welovetrump.com/2021/08/03/finnish-firm-scores-us-patent-for-nasal-spray-drug-that-includes-hydroxychloroquine-ivermectin/
Thank you for the information. Hard to imagine in this day and age the difficulty in finding up to date accurate information. These forums and links have been quite helpful.
I'll give the quick answer here - those are not generally vaccine deaths. Those are deaths that happened after being vaccinated, where someone decided to report it to VAERS (or similar). But when half the population has been vaccinated, the normal background level of deaths is going to be substantial - several thousand people die in the US every day, even at the best of times.
If you look at the actual reports, most of them are either things like "Patient was 95 and terminally ill with cancer", or "I don't see any reason to think this was connected, just reporting it for completeness". https://vaers.hhs.gov/data.html is the raw data for the US, and while it takes a bit of filtering, you can look through it yourself and see if it matches what I just said.
And if you look at what these systems are for, this is 100% expected. The whole point here is to get a big data set and see if things are happening at unusual rates. If a vaccine caused spontaneous human combustion, that's obvious, because that doesn't happen normally. But if it causes, say, a higher rate of heart attacks? Those happen all the time, and you need a big data set to figure out if it's coincidence or an actual side effect. Hence why they ask for a big data set.
You can report "My buddy got hit by a bus walking out of his vaccine appointment" to VAERS. And not even as a joke or a failure mode - if they suddenly get twenty times as many bus accidents as normal from a vaccine, then maybe they need to see about dizziness or judgement issues as side effects. But if there's only one bus hit in the data, that's just a thing that happens. You can't count that one as a vaccine-caused death, any more than it was a death caused by having pancakes for breakfast that morning.
I do not know how the UK does their reporting but it seems they are doing their best to track fatalities from the vaccines.
Also, the reporting from the National Vaccine Information Center (medealerts) seems to provide good information regarding each the patients who died.
If anyone is looking for alternatives to the vaccine, this site tracks all the research/studies:
COVID-19 early treatment: real-time analysis of 784 studies
https://c19early.com/
Prayers for everyones safety
Please don’t expect ivermectin or whatever to actually work for early treatment. A thousand secondhand claims a doesn’t substitute for one solid piece of evidence, and a thousand bad studies can’t stand in for even one good one. Also lmao @ Curcumin (https://blogs.sciencemag.org/pipeline/archives/2017/01/12/curcumin-will-waste-your-time, Well, for one thing, curcumin’s stability and pharmacokinetics are absolutely terrible. It’s less than 1% bioavailable, and its half-life under physiological conditions is measured in minutes. This makes a person wonder how it can be such a wonder drug. The authors of the current paper, indeed, state that “To our knowledge, (it) has never been shown to be conclusively effective in a randomized, placebo-controlled clinical trial for any indication“. )
You say that the CDC reports 6,340 deaths from the vaccine.
They most assuredly do not.
That total includes people who have died from any cause whatsoever, including drowning, shooting, car accidents etc etc.
What you might have missed right at the beginning of their report in a nice clear bullet point, was this -
"Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem"
Apologies for snark. Alsadius gives a much better response to the OP.
For your final point, a patent isn't the same as a clinical trial. I believe that's more for the delivery method/cocktail. It shouldn't change your opinion on the effectiveness of either/both of these medications, because the awarding of the patent is not dependent on those. I think this is essentially not a news story, and was just written because it has some hot-button words and can be spun to make the CDC look bad.
With the caveat that prophylactic/early administration was not thoroughly tested, the weight of evidence shows that HCQ is ineffective at changing outcomes for severe COVID patients. Ivermectin is murkier, the data is not strong but there could be something there. I've had a discussion in the past with jstr about this: https://astralcodexten.substack.com/p/open-thread-1745/comments#comment-2128593 there are some good links and commentary on meta-analyses in there.
You have mistaken the nature of the UK report, which does the same thing the VAERS report in the US does, as Alsadius has explained quite well below. On the very first page of the report you linked it says:
"A report of a suspected [adverse event] to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have. Underlying or previously undiagnosed illness unrelated to vaccination can also be factors in such reports. The relative number and nature of reports should therefore not be used to compare the safety of the different vaccines."
That is, in short, just the the CDC VAERS system, they are just keeping track of everyone to whom anything bad happened after being vaccinated, so they can later look into it carefully and pick up anything that is actually related to the vaccine, as opposed to being a coincidence.
Nobody knows yet whether it means something. It certainly means the vaccines aren't an utter disaster, worse than the disease they prevent, because if they *were* you would have more than a milion or more deaths reported to the VAERS system already, plus one assumes anywhere from 5-30 million additional very serious but not life-ending consequences, and it would be an enormous, gigantic, awful and obvious disaster.
The Phase III trial established odds of bad side effects that are lower than 1 in 20,000 or so, because they monitored about 20,000 people very closely for side effects and saw nothing of consequence. But that does *not* mean that the odds are zero. Odds of anything evil that were rarer than 1 in 20,000 would not be picked up by the Phase III trial, unless they were lucky.
Hence the VAERS system. It allows for the collection of data after the vaccine is deployed, so that people have data they can dig into later to discover problems that might be down at the 1 in 200,000 or 1 in a million level, and so which only turn up when you hand out 350 million doses, which the US has done so far.
*Is* there something down around the the 1 in a million probability level? And if so, how bad is it? These are questions that no one is in a position to know, right now. The data from the VAERS system (and its UK and EU equivalents) is just raw data right now, just writing down the numbers, "so-and-so was vaccinated June 5 and such-and-such bad thing happened on June 30." It will take years of careful study for people to dig into that data and try to separate out any genuine connection between bad events and the vaccine from the forest of random bad stuff, and bad stuff that happens for reasons other than vaccines, that happens every day to people.
It's a bummer we have to decide whether to take a vaccine not knowing whether it's got a 1 in a million chance of giving us brain cancer or something, but that's medicine, or life for that matter. There are no guarantees, you can only play the odds. The point of the VAERS system is for the future to be better informed, just as we are better informed because of the chances our grandparents took. (In the earlier days of the polio vaccine, early manufacturing challenges led to quite a number of vaccine-induced polio cases, and some deaths. From those unfortunate events, we learned better manufacturing and better protocols, from which the present generation benefits.)
Yes, I mentioned this below as being wholly unsurprising. There were way more vaccines given this year in the US than in any recent year, so not surprisingly the number of deaths that occurred after a vaccine was given is way higher.
Imagine we had a system that recorded deaths occuring within a week of when people were wished "Happy Birthday!" and for some weird reason in 2021 the law mandated that everyone wish "Happy Birthday!" to everyone they met once a day. The system would be flooded with records of deaths following birthday wishes, but of course on investigation that would turn out to be complete coincidence. Whether the same is true or not for the vaccines we don't know yet (although it is quite likely a priori).
When I saw "we" decide I don't necessarily mean "we as individuals," it includes the possibility of "we as a collective," meaning we elect governors, legislators, and a President, and based on the nature of who we elect they pass laws and issue decrees and otherwise make collective decisions in our names. That's how a democratic republic works, for better or worse. Not *all* decisions are left to the individual, and traditionally decisions affecting public health in the area of communicable disease are one of the few categories in which we traditionally accept that individuals often *don't* get to decide, e.g. if you get TB and decline to take your meds exactly as a physician prescribes, you can in most states be locked up until you do.
Although I have a strong libertarian bent, I'm OK with this, for the same reason I'm OK with the government requiring you not to drive with a BAC above 0.08, and locking you up if you refuse, *whether or not* you individually decide (even correctly!) that you personally can handle it. My ideals of liberty stop short when the free decisions of others pose risks to me and my family that are too difficult for me to defend against on my own, and communicable disease definitely falls into that category.
I might feel differently if I thought vaccines posed significant risks, comparable to the diseases concerned, but I don't. I also might feel differently if I thought reasonable men could conclude, after a sincere and careful examination of the evidence, that vaccines pose significant risks. But I don't.
Why have the reports? So that if the vaccine for Placeholder's Syndrome causes heart attack rates to jump by 50%, you have the statistical power to notice it. That's a fairly big effect in the grand scheme of things, which would cause a lot of deaths in this hypothetical. But no individual heart attack would raise any eyebrows. They happen all the time to people. You would need thousands of reports to be able to say "Hey, wait a minute..." with any degree of confidence. So you ask people for thousands of reports, and then you do stats on those reports.
99.9% of the time it's nothing - all those people who got the Placeholder's Syndrome vaccine and then developed cancer, or Alzheimer's, or diabetes, or high blood pressure? They actually were coincidental (in this hypothetical). But you have to ask about all of them, because you don't know in advance which of them the actual issue will be (if it's any of them at all). You need a big enough data set to find out. Even if all you eventually find out is "Yeah, this is just the normal background rate for gangrene. Sucks to be you, but I see no reason to think it's connected."
The clinical trials are designed to be large enough to rule out side effects that are worse than the disease itself. That's why for COVID vaccines they were quite large (e.g. 60,000 people), while for something like a new cancer therapy for people with metastatic disease, they can be much smaller (a few thousand people): if you're trying to stop death in a patient who's two inches from it, you don't need to rule out evil side effects at nearly the same level of confidence as if you're vaccinating perfectly healthy 16-year-olds against a disease that has a 0.02% chance of killing them.
That gives the FDA enough data to approve the drug, but only barely. They don't do bigger or longer trials than barely sufficient because they're incredibly expensive already, and account for much of the enormous cost to bring a drug (or vaccine) to market that causes the outrageous prices of approved drugs on patent.
But the existence of the VAERS (and other post-approval data collection efforts) allows people to go back later and dig into the data when the drug/vaccine is given more widely, to refine our understanding of side-effects (and effectiveness for that matter). That can lead the FDA to modify its approval, in principle even revoke it, or add "black box" warnings, require additions to the prescribing recommendations, et cetera. It can allow manufacturers to update guidance to physicians in useful ways ("avoid giving this drug if the patient has Weird Condition X or is in Demographic Category Y").
I wouldn't attach much meaning to the fact that there are more deaths reported to VAERS this year than in other years. Recall a death is reportable if it happens after a vaccine is given, full stop. There need not be any causal relationship at all between the vaccine and the death, and presumably in most (if not nearly all) cases, there isn't.
But since *way* more vaccines have been given this year in the US than in any ordinary year, like hundreds of millions more, then obviously a much larger number of deaths become reportable to VAERS, in the sense that necessarily a lot more deaths happened after a vaccine was given, simply because a lot more vaccines were given.
Clinical trials for these vaccines were about 20,000 people. The real-world deployment is in the hundreds of millions. If one in a couple thousand people gets a heart attack from it, you can miss that simply by random chance in a trial. You will not miss it in a group of hundreds of millions, if you have a VAERS-like system.
(And no, the solution isn't bigger trials. Bigger trials mean giving less-tested drugs to more people, which has its own risks, even before you deal with the cost issues).
As for why there's more reports, perhaps it's because most previous vaccinations were aimed at kids. When you vaccinate a bunch of pensioners, the background death rate is a whole lot higher. We're also (plausibly) giving more people vaccines this year than we have in the past 30 years combined. Also, we're thinking way more about vaccines and VAERS as a society than we ever did in the last 30 years.
Thank you for making that clear to me.
Weird to write a whole article about this without taking a look at how other first-world countries manage this, to see if they're doing better/worse than the US and why.
It was a pretty substantial article as it is. However, I do keep hearing about the EU permitting useful things which aren't allowed in the US.
I'd heard that the EU permitted bandages with clotting powder for surgery while the FDA didn't. The bandages seems to be available in the US now-- they're even over the counter.
A fast search didn't turn up the history, though.
They also approved the first beta blockers about a decade before the US, there's the better sunscreen, better anti-nausea drugs, and the dozen competing epi-pen equivalents that keep prices there down.
I think they're broadly similar and, while they do get some things right that the FDA gets wrong, the reverse is also true.
My favorite tidbit hinting at how crazy all of this probably really is is the huge differences in the RDAs (recommended dietary allowances) for various vitamins and minerals are.
I think this analysis misses the primary point of FDA caution: Thalidomide.
AFAIK, thalidomide is why the FDA expanded out of food. The horrific birth defects arising from Thalidomide use are extraordinarily costly and the impact was small only because it was prescribed for a small subset of pregnant women.
The fear has always been that some other widely used drug will have comparable negative effects - you know, like those spanking new mRNA vaccines.
If they do prove to cause some sort of nasty long term damage, then administering said mRNA vaccines to literally hundreds of millions to billions of people would net a ginormous problem.
I would note from this perspective: aducanumab is relatively low risk from a health perspective.
If it doesn't do anything, it only hurts pocketbooks.
If it causes brain cancer, the dementia patients it is prescribed to are not losing a lot of life expectancy nor are the births of the next generations affected (they're already born).
The 'F' in FDA is for "Food". The 'D' is for "Drug". There was no "expanded out", they regulated drugs from their founding. It was even in the name of the 1906 Pure Food and Drug Act.
Per this site: https://embryo.asu.edu/pages/us-regulatory-response-thalidomide-1950-2000
"Prior to discovering thalidomide's teratogenic effects in the early 1960s, the US Food and Drug Administration (FDA) did not place regulations on drug approval or monitoring as it later did."
Clearly your grasp of history is poor.
No, they regulated Drugs just like they regulated Food: they ensured what was being sold was pure rather than adulterated. They did not "expand out of" Food to drugs.
You can argue all you want but the facts are that the FDA did not approve drugs prior to Thalidomide.
"Pure" thalidomide vs. "not pure" thalidomide is a product quality issue, but "approved" vs. "not approved" drugs is an efficacy and safety issue.
You might consider re-reading the article: it doesn't talk about the FDA checking the purity of aducanumab. It talks about whether the FDA's approval process is too slow or not.
Your quote in your previous comment doesn't quite support your claim in this one:
> Prior to discovering thalidomide's teratogenic effects in the early 1960s, the US Food and Drug Administration (FDA) did not place regulations on drug approval or monitoring as it later did.
That might just be claiming that they _changed_ the way they regulated "drug approval or monitoring" (but it is a little ambiguous).
The Wikipedia article on the FDA also seems to contradict your quote and claims:
> President Franklin Delano Roosevelt signed the Federal Food, Drug, and Cosmetic Act into law on June 24, 1938. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove fraudulent intent. Soon after passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of "prescription-only" drugs was securely codified into law by the Durham-Humphrey Amendment in 1951.
That seems to be relatively strong evidence that "thalidomide is why the FDA expanded out of food" isn't particularly accurate, even given your subsequent qualifications.
I definitely think you're right that, in the wake of the findings about the effects of thalidomide (when taken during pregnancy), the FDA regulation of drugs changed dramatically.
I think what you wrote is fair - the question is when did FDA approval actually mean something as opposed to FDA "pre market review" or "safety review".
It is abundantly clear, however, that FDA approval did not exist when the FDA was created nor did "approval" mean anything like it does today when the agency was written into existence in 1938 - regardless of what the name of the agency says.
After all, the SEC is supposed to regulate securities...how's that working out?
I'm not arguing with the article, I'm arguing with your characterization as "expanding out of food".
Let's not get nasty.
"But when the US declared that the coronavirus was a “public health emergency”, the FDA announced that the emergency was so grave that they were banning all coronavirus testing, so that nobody could take advantage of the emergency to peddle shoddy tests."
To be fair to the FDA when the bargain supermarket chain Lidl starting selling Covid test kits here in Ireland in May, our public health authority was telling people they were useless and not to buy them, and there was a sharp exchange of views on Twitter between duelling experts:
https://www.rte.ie/news/primetime/2021/0511/1221060-antigen-testing-controversy-general-public/
They give quick results. They are cheap. And they are relatively easy to use. But the arrival of rapid antigen tests on supermarket shelves last Friday has not been without controversy.
Lidl stores are selling their Covid-19 test kits at €24.99 for a box of five. NPHET has cautioned consumers not to use them, with Chief Medical Officer Dr Tony Holohan noting that he is very concerned that they will "falsely reassure people".
NPHET's Prof Philip Nolan, meanwhile, traded barbs on Twitter with Harvard epidemiologist Prof Michael Mina, saying his "snake oil" comments "further sows confusion".
Prof. Nolan on the Lidl ad for the kits: "Can I get some snake oil with that? It makes for a great salad dressing with a pinch of salt and something acerbic. Stay safe when socialising outdoors over the next few weeks. Small numbers, distance, masks. These antigen tests will not keep you safe."
Prof. Mina to Prof. Nolan: "For an advisor to your government - you don’t appear to know what you are talking about @President_MU wrt rapid tests.
The comment adds nothing of benefit and further sows confusion.
You should be ashamed of your demeanor here."
Aducanumab also has nasty side effects, including brain swelling and brain bleeds in 30% of patients. Those should be a factor to consider when weighing the cost-benefit calculations of the drug as well.
"This policy has led to our current situation, where either everyone has to be miserable because of stupid people’s choices (eg everyone has to wear masks forever because a few people won’t get vaccinated) or we get a strong anti-freedom lobby because allowing anyone any freedom means that the rest of us have to suffer for their stupid choices."
I am not so sure I follow your point here. It strikes me that "everyone has to be masked because some people won't get vaccinated" is a by product of really bad risk analysis and systemic knowledge, not so much the FDA's own doing. The FDA is guilty of that same bad analysis, but not because they scared people away from the vaccine, I mean. It seems to me that the real mistake was over promising on the vaccine in general on a few margins.
1: The vaccine was never likely to eliminate COVID. We have eliminated exactly 1 disease in the wild, smallpox; everything else still pops up from time to time. Worse, coronaviruses are notoriously hard to vax against because they mutate all the damned time. Claiming otherwise was a really bad move by the FDA/government/doctors/media/whomever got it into people's heads that we could possibly eliminate the disease like it never existed.
If you think that we could eliminate the disease, how many humans all over the Earth do you think we need to vaccinate before we wipe it out? 5 billion? 6? All 7+ billion? I would put forth that it must be a very high percentage given that COVID spreads easily and hides out in people for a bit, and given then the vaccine behavior below...
2: Overpromising effectiveness of the vaccine. Does the vaccine keep you from getting COVID, or just keep you from getting sick if you get the virus? If you get COVID after being vaccinated, does the vaccine prevent you spreading COVID? I honestly can't tell what the CDC or other public health groups think the answer is here.
If the vax keeps you from contracting the disease at all, that is, you get some virus and it gets destroyed before it infects cells or spreads, you don't need a mask at all. (Unless just breathing in some virus from person B then breathing it back out to infect some person C is possible, but then unless you were holding your breath for a while, C could just get it direct from B.)
If the vaccine keeps you from getting sick but allows you to still be a host/carrier of the virus so you can transmit to others, then the vaccine isn't going to stop anything spreading. It might slow down spreading somewhat, but so long as vaccinated people can host there will always be some vectors for transmission. At that point you are just hoping the spread drops below 1 such that eventually the disease just dwindles. Maybe masks make sense in this context if you have been vaccinated, but there is no logical stopping point to that; you are just going to wear masks forever because anyone might be a stealth host until at some point in the future there are effectively zero cases. (Which will never happen if variants pop up that get around your immunity.) Then again, in this case, if you are vaccinated you have no personal risk, so people who are unvaccinated don't exert any externalities on you. So, why wear a mask? Just let those who chose to be unvaxed pay their price. Those who can't be vaxed will need to take tons of precautions in any case, because you can still spread to them, so there is no difference there.
Or... maybe the vaccine doesn't protect 100%, doesn't stop transmission, and won't wipe out the virus, which will mutate anyway. So we are back to the human norm of having one more minor contagious disease that kills us periodically but can be treated pretty well, and more possibly even largely avoided by getting a shot, possibly yearly. In which case, wearing a mask all the time only makes sense if you are a germaphobe or otherwise around people you expect to be contagiously sick, like doctors.
Anyway, yea, I am not sure I get your argument there. The problem to me seems to stem less from people not trusting the FDA, which they shouldn't, and a lot more from people having a really bad underlying model of reality, one in which people never die unless some monster kills them, and said monsters can be eliminated if only the bad people who allow the monster to keep living could be made to stop doing that. This as opposed to the model where nature is constantly trying to kill us, and we are mostly pretty good at avoiding that, but we are not going to ever get it to stop completely. We just knock the sharp edges off the worst bits and try to sand down the rest while doing the best we can with the time we have.
I'm not going to go through your post point by point but the overall impression is that you are attributing statements to the FDA, CDC etc. that are actually the result of bad reporting. Throughout this entire process we've had variations on this theme:
Scientific report says, "In the extraordinarily unlikely case where no behavioral changes occur we would expect 4 million dead." The headlines scream, "Scientists expect 4 million dead!" And people who just read the media reports rather than the original source say, "These scientists are full of it."
I would like to signal-boost this.
I am trying to understand Scott's line about being masked forever because some people are not vaccinated. I am assuming that it is based on sort of the folk theory of how things are working regarding vaccines, masks, etc. If you read carefully, I don't attribute any particular thing to the FDA or CDC, but rather said that people in general (including the FDA) seem to have a bad mental model of the world, and someone put it there.
Now, I did say there were over promises made about the vaccine, and that I don't know what the CDC/FDA/public health orgs in general think the answers are there. Their recommendations have not been terribly clear to me on those points.
So... what statements am I attributing to the FDA, CDC, etc.?
Specifically item #2. Are you referring to the information released by the FDA, Pfizer, etc. or are you referring to news media reports that attempted to summarize that information?
I'm certain that the Barnard English majors who went into journalism are doing their very best to report on the data coming out of the FDA. But that their skillset means that a lot of the scientific and statistical nuances escape them - the put it mildly.
In reference to #2, take a look at the CDC's page here: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html . This page suggests to me that while the vaccines make me largely immune, I can still get sick from COVID, and still spread it. In fact, I need to still wear masks on public transportation for that reason. The CDC further states that the vaccine is an important tool to stop the pandemic here https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness.html . Which all boils down to the last case I described,
"Or... maybe the vaccine doesn't protect 100%, doesn't stop transmission, and won't wipe out the virus, which will mutate anyway. So we are back to the human norm of having one more minor contagious disease that kills us periodically but can be treated pretty well, and more possibly even largely avoided by getting a shot, possibly yearly. In which case, wearing a mask all the time only makes sense if you are a germaphobe or otherwise around people you expect to be contagiously sick, like doctors."
So, why does the phenomenon of some people not getting vaccinated lead to everyone wearing masks forever again, which is what all this was asking about in the first place?
I would expect the CDC to recommend anything at all to reduce transmission, no matter how low its effectiveness, because they aren't doing political cost-benefit analysis. How could they? They're epidemiologists, Poindexters in lab coats. They have zero understanding of social forces or politics, which is why they got a PhD in biology in the first place.
So they're not in any position to say "well...if we recommend mask mandates for all it would be a tremendous political struggle, and x% of the target audience will flip us the bird anyway because of the absurdly low return of vaccinated people wearing masks, so it's just not worth the damage to the social contract -- let it go (or do something else)." Those are political and sociological decisions, and we elect politicians to make them.
Why would *politicians* preach mask mandates for all because of the (very small) risk of vaccinated individuals passing the bug along? There are two political reasons I can easily imagine for the current Administration (and those of certain states, like California):
(1) To try to recruit the vaccinated into pressuring the unvaccinated. 'Would you go get the God-damned jab so I can stop wearing this silly mask?' That doesn't seem super plausible, because it's childish and it's hard to see anyone of sophistication believing it will work, but politicians *are* sometimes childish.
(2) Because a squalid little secret is that the majority of unvaccinated are *not* fiery libertarians or Trump fanbois. I mean, some of them are, but not most, because there really aren't enough of those people. The bulk of the unvaccinated are poor, poorly educated, and minority people -- i.e. major Democratic constituencies. It would be a very delicate thing for Democratic politicians to pull off saying 'Hey all you poor/low-education/minority people, it's *your* fault this pandemic isn't over, go get your vaccine!' or 'Only YOU fools need to wear a mask, all the people who got vaccinated don't.' So instead they roll it all up into a big "we" as in "we ALL need to wear a mask/get vaccinated because this thing isn't over yet."
That fact that (2) is a political decision, and from some points of view can seem pretty cynical, doesn't mean it's *wrong*. If the goal is maximum public health as soon as possible, it may work better to "recruit" the slackers by the rest of us acting as if we're in it too, like it's a truly all-for-one, one-for-all effort. Enhancing division by pointing fingers at people who already have some general reason to suspect they're treated with extra contempt by everyone else could backfire badly, and make the overall situation worse.
Or not. I'm just speculating. If I understood how to make good political leadership decisions, I'd've run for Congress instead of getting a PhD and being a Poindexter myself.
https://www.smbc-comics.com/comic/2009-08-30
For some reason, the idea of allowing FDA to grade its approval with stars seems to be dangerous. If the FDA grades a medicine 4 stars, and it causes cancer in a whole city, it can honestly just get away with saying "well we never completely approved it. We just gave it four stars". There's definitely some upside to FDA approvals being binary instead of being graded.
Of course, like Scott said, we have to do a cost benefit analysis, and we might even conclude that in the overall picture, having this graded star system is more beneficial than allowing FDA to drag its feet on things like the coronavirus vaccine. However, it will still be important to hold to FDA accountable for its ratings. Its four star drugs should not be as dangerous as one star drugs (it should have at least an 80% success rate and only a 20% incidence of serious side effects or something like that).
I do think that prediction markets will solve this problem nicely, as noted by another commenter. Worried about taking a four star FDA drug? Well Kalshi says that there's a ~0 chance that this drug is harmful, and this prediction is probably informed by decentralized expert opinion. Hence, it's probably fine.
"Patients will have to choose which insurance to get"
That's not how insurance works in the US as you know...
You also seem to totally discount the existence of bad actors knowingly attempting to get dangerous drugs they know don't work approved. That's where you argument really breaks down.
>That's where you argument really breaks down.
How, exactly? Suppose those actors manage to push through their snake oil at two stars, where regular doctors still can't prescribe it, what catastrophe would this cause?
My point relates to the larger question of the FDA being a lot more liberal in its drug approval process. Any such proposal needs to acknowledge the existence of bad actors.
The system that Scott described doesn't seem to be obviously vulnerable to them, and it's uncharitable of you to assume that he didn't consider this at all.
It seems obviously vulnerable to them to me.
Like I said, how, exactly? Can you make a clear example of what would obviously go wrong?
What could obviously go wrong? Well the prescribing experts could be defrauded by an unscrupulous drug developer into giving thousands of people dangerous drugs that don't work.
There were terrible abuses prior to the mid twentieth century, like the radium potion that makes your jaw fall off. And that's the motivation for setting up these agencies. I wonder if that stuff is still in folk memory?
The other issue is what do we mean by bad actors. There are people who are knowingly and with malice creating a dangerous product they know doesn't work. And then there are people who set out to create a wonderful new product and staked their fortunes and reputations on it and when the data started coming in the convinced themselves that it really was safe and effective when it clearly wasn't.
Yeah, I'm sure Biogen's executives aren't sitting around twirling their moustaches and cackling, they probably think they're producing a new therapy that has been proven to work on amyloid plaques, and that might help with Alzheimer's if you give any credence to the plaque hypothesis, and it's a terrible illness so what harm can it do and it might help?
And since it's really expensive to do the research and get the approval, they need to set the $50,000 price tag.
I thought this approval might boost the share price, but while it seems to have pushed it up a little, some people are selling their stock since they think the controversy around Aduhelm will damage Biogen:
https://www.fool.com/investing/2021/08/05/why-i-sold-my-biogen-stock/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article
"The largest factor in my decision to sell is that I lost faith in Biogen as a result of how it is handling the Aduhelm approval on several fronts. The most important of these is regarding Aduhelm's efficacy.
...In summary, Aduhelm does something, but whatever it does isn't enough to reduce Alzheimer's symptoms, and it's unclear whether it can slow or halt the disease's progression. It's hard to believe that there could be a vibrant market for a drug that doesn't actually help people.
Despite knowing all of the above, Biogen decided to move forward with the approval process, thereby exposing its investors to additional risk. Per regulators, the company now has nine years to perform additional clinical trials to find evidence supporting the drug's benefits. If that future evidence solidifies the idea that Aduhelm's benefits are largely theoretical for patients, it'll lead to vastly less revenue and significant losses for shareholders.
Early pricing and revenue stumbles may just be the start
Then there's the issue of the drug's anticipated $56,000 annual cost. That's a huge price tag for something that hasn't been proven to work, and it'll be a hard sell to get Medicare and private insurance to cover it. And numerous healthcare systems, including the prestigious Cleveland Clinic, have opted to refrain from administering the drug until reviewing the existing data themselves. Sales will be slower to ramp up as a result.
Management is defending its decision to move ahead with Aduhelm by painting public criticism as being rooted in misinformation about everything from clinical trial design to regulatory matters and efficacy data analysis. And it says that the launch price of the drug was calculated "based on our belief in the impact of treatment," which, in view of the data about Aduhelm's impact on patients, inspires zero confidence. Furthermore, management actually has had nothing to say about the most important problem: Aduhelm doesn't appear to lead to clinically meaningful improvements for patients.
Still, it's true that Biogen has other Alzheimer's drugs in its pipeline, and other sources of revenue. But given the precedent it set with Aduhelm, it's difficult to be confident in the company's judgment about which projects merit moving ahead. And per its second-quarter earnings report, sales of its other approved drugs are faltering, with revenue dropping by 24.6% year over year. So there's a lot riding on Aduhelm, and right now it looks like the drug won't live up to expectations."
So things may get interesting, if people decide to dump their Biogen stock in anticipation of bad results, then somebody swoops in to buy it cheap: a good gamble, should the other drugs work out, or left with egg on your face if Aduhelm pulls everything down?
If the bit here about the second-quarter returns is true, then maybe Biogen did lean on the FDA to approve the drug since they *need* it to sell in order to save their financial bacon?
Not a great impetus for decision, and a poor precedent, if it's the case.
> You also seem to totally discount the existence of bad actors knowingly attempting to get dangerous drugs they know don't work approved.
I'm skeptical that these "bad actors" exist.
Or does that hypothetical group include people that are (grossly) negligent? I admit that that's an omnipresent risk given, e.g. wishful thinking.
But I don't think there are any significant numbers of 'bio-terrorists' deliberately trying to get "dangerous drugs they know don't work approved", or, as you described them in a subsequent comment in this thread [emphasis mine]:
> There are people who are knowingly and _with malice_ creating a dangerous product they know doesn't work.
_Maliciously_ trying to get a drug approved, i.e. to deliberately injure (or kill) people, seems very far-fetched. Are you imagining something like a serial killer that works at a pharmaceutical company?
Did you not see the spam link to the doctor that claims he can cure AIDS and anything else for that matter with herbs in this very thread? That kind of thing is not rare.
I did! But this then is a nearly perfect instance of "One man’s modus ponens is another man’s modus tollens"!
My point is that, given that the FDA currently exists, people still persist in spamming links like the one you mentioned (and that I myself have seen, twice, in this comments on this post).
But I still don't think that, if the people responsible for that spam _would_ actually give anyone anything to ingest claiming that it would treat a serious medical condition, that they would do so out of a desire to actively _harm_ anyone. It seems to be a strictly (vastly) superior strategy to, if you're going to actually give anyone anything at all, to give them something either entirely benign or only minimally 'harmful'.
I think it's far more likely that it's a more pure scam tho than that – they don't intend to actually ship anything to anyone but just to fraudulently charge them for a non-existent product.
Or do you think there are serial killers attempting to kill people by advertising alternative medicine? I've never heard of any – and there are already lots of opportunities for someone to have done so!
I do believe some of these people might be malicious in the sense of intending to harm people _financially_. I'm still skeptical that any of them are trying to harm anyone _physically_ or medically.
I guess I don't know where you're trying to go with this. You seem to be trying to play a game of gotcha with, " would do so out of a desire to actively _harm_ anyone." If you have AIDS and I tell you that the drugs proven to treat it are all a scam and you should take my herbs - what does it matter if the herbs are benign? You're still killing someone.
I thought you were claiming that people not only had a desire to fraudulently sell 'fake medicine' but to actively poison people too.
In the case of AIDS, selling someone herbs would be pretty similar _because_ there are existing alternatives that DO work.
Let's take something else – like Alzheimer's, for which there _are_ no effective treatments currently (AFAIK). I agree that some people would 'maliciously' try to sell Alzheimer's treatments. I _thought_ you were claiming that people would to try to sell, e.g. cyanide, as an Alzheimer's treatment. In other words, beyond just defrauding people, or maybe not even because of that, they'd want to just hurt or kill people as their primary motive.
Why would I claim that?
Indeed in a lot of cases I think these people have convinced themselves that their snake oil actually works. That’s why they are dangerous.
"I think the current state of the art is something like Isakov, Lo, and Monterhozedjat , which finds that there are a tiny few disease categories where the FDA might be slightly too aggressive, but that overall the FDA is still much too conservative. "
I might have missed something but I think this is a misinterpretation. They say that for severe diseases the FDA is too conservative, but for for more minor ones it's too lax. Since they only ran estimates for the 30 leading causes of premature mortality it shouldn't be surprising that, for most conditions they studied, the FDA is too conservative, because most of those are pretty severe diseases. But I'm not sure you can generalize that to say that there's only a tiny few disease categories where the FDA is too aggressive.
Could something similar to the UL model work for drug approvals?
Can you share an outline or sketch of the "UL model" and how it would work for drug approvals?
(Medical) Insurance companies (voluntarily and directly) fund a "privatized" organization to certify safety of medicines and treatments.
UL, after all, stands for Underwriter's Laboratories - the Underwriters in question insure property (or did at the beginning).
Property owners don't have to buy UL-certified equipment, but...
So sort of like how S&P and Moody's rate mortgage bonds?
Not quite - because of what you note below - the ratings agencies do not have skin in the game.
There IS an element of moral hazard still, in that the insurance companies have an interest in the insured dying early, that is not present in the home (and auto - The Insurance Institute for Highway Safety is another example of such a plan) insurance industries, in that death is not an insured event the way a housefire is.
Perhaps we should make health insurance companies issue companion life insurance policies?
The other issue is having personal skin in the game. If you’re a VP making $800k and your options are foot down now and get fired or get fired 3-5 years down the road when it blows up, your incentives are to wait.
There's no perfect system. And in fact I see several issues with this one. It's an interesting thought experiment, but with guaranteed issue, a problematic one
Thanks!
That is something I've long been interested in, particularly given the (implicit) option of having competing organizations.
I've long thought the way 'kosher' organizations work – kind of like of competing (private) FDAs – is really interesting, potentially better than the status quo, and in a real sense, a kind of 'formalization' of what people do anyways, e.g. trust specific people and organizations for authoritative advice.
That's another good example
That's not a terrible idea. Especially if there's some skin in the game, so they assume some risk for approvals. One of the biggest issues I see with an agency like the FDA is there's no REAL accounting either way; do well, do poorly, doesn't matter, you get your check.
Skin in the game is key. IIRC S&P and Moody's got out of any MBS liability be claiming their ratings were first amendment protected opinions and thus they couldn't be held liable when all the AAA bonds defaulted.
Are you saying that the FDA decisions during Trump years were not at all affected or decided by Trump Admin.? I understand that this cannot be the case with the Altz. drug., but the question remains.
I doubt any president has much of an impact on the FDA or any other bureaucracy. The FDA is over a century old, has about twenty thousand employees, and since 2016 there have *9* different commissioners at the FDA.
Under what mechanism could a president plausibly have *any* control over this organization?
Admin appoints leaders of these agencies.
That is why I mentioned the 9 different commissioners. Exactly what is a commissioner going to change in less than a year? And for everyone that works there, why would they listen to a commissioner that will only be around for another year?
The commissioner probably can't fire anyone with real power at the agency. They might be able to make a few new hires or replacements for things they care about.
They can set mandates or goals for the agency, but what reason does anyone in the agency have for following these mandates or goals? They'll follow if they want to, but if they don't want to they can just drag their feet until the commissioner is gone.
No, but Trump appointed Scott Gottleib as commissioner, a pretty respectable guy similar to the kind of person any other president would have appointed. I don't think it was very affected by the general Trump dysfunction, though I could be wrong.
So modest proposal.
Let's say instead of $50K, the drug is $75K. BUT the $25K is set aside in a 401K type trust fund that invests in the S&P 500 and creates shares in a company. Let's call it the Bad Luck Corp BLC.
Shares of the BLC will be split 1/2 to the patient, 1/2 to the payer (i.e. insurance company or gov't program). At a certain point in time, let's say 20 years, the funds are relesed to BLC if a patient has the disease or has died from it. If the patient does not have the disease or has died previously from something else (motorcycle accident say), then the funds go to the drug company.
BLC stock then will trade over time and go up if it appears the drug works less well and down if it appears it works better than expected. Both patients and payers will get the benefit of a rising stock if they 'overpaid' for the medicine earlier in their lives. They won't get any benefit if the drug works very well, obviously, but then if that is the case it is a win for patients and the rest of society if this drug (or some future drug) ends up being the mRNA vaccine of Alzheimers. Note that the benefit happens even if the patient themselves does not get Alzheimers. If your father takes the drug, gets a lot of BLC shares, but then dies in the motocycle accident, the BLC shares are part of the estate and can still go up should the drug turn out to be a dud.
Thoughts?
Note BLC is tradeable. If you take the drug, get some shares, you can sell those shares whenever you want. You don't have to wait to get Alzheimers. Of course like Gamestop or Bitcoin the stock may trade up and down running off little tidbits of news and fashion.
Few more notes:
- When the FDA approves a drug using a surrogate endpoint, it triggers a BLC. The idea of a surrogate endpoint is "We can't wait long enough to see if this drug extends lifespans, lowers heart attacks, or prevents Alzheimers but we can see it does help this metric we think, but don't know, is related to that end point". The FDA would decide how long such an endpoint would be in the future. A company can avoid this by doing the studies to prove the drug works on the underlying endpoint.
- Insurance companies can use the BLC stock prices as a guide to approving drugs or not. When a BLC's stock price starts to go above a certain point, the payer can say "look the market is indicating this drug probably doesn't work so let's have a conversation about how much we'll cover it despite FDA approval".
This is better, IMO, than Scott Alexander's idea about health insurance that doesn't cover this or that expensive drug. How am I supposed to know that I won't benefit from this drug in the future? I'm just guessing and many people will simply revert to price shopping.
I'd like to take this one level of abstraction higher and all government and government related agencies are slow and disfunctional at best. Using proof by induction, with the DMV as our base case and the FDA and Congress being random N and N+1. In my semi-formal analysis all government agencies are awful. But the FDA has probably killed the most natural born citizens, while the DMV just annoys and angers them.
That being said, if we can reform the FDA to stop killing people, lets not stop the reforming at just that agency. The only real way I see that change could happen is if incentives changed to where there is competitive pressure to work at these agencies, rather than our golden ticket type standard right now of going through an insane hiring processes but once you're in you're in.
I'm not holding my breath.
I'd like to take a minute for speak up for the DMV. I go in, I take a number, I have a look at the display to see how far out I am, I sit for between 10-30 min, playing with my phone or reading a book until my number is about to come up, and then I get taken care of. It could stand to be over the phone or online, but then, I can get some stuff online now, and the rest they want to be able to look at me and make sure I am who I say I am. It's reliable and not that much of a pain in the ass. I don't know how they and the Post Office got to be the watchword for bad government agencies.
This Cochrane review says that fish oil doesn't make a difference in IV infant formula: https://www.cochrane.org/CD013163/NEONATAL_systematic-review-lipid-emulsions-intravenous-nutrition-preterm-infants
^This is the most important comment so far. Maybe the FDA was right all along.
The point made in the article wasn't about general infant formula, but specific nutrition for a rare condition. Not an important comment at all.
oh god
Isn't the review stating that it doesn't make a difference in general, but may* for infants with "pre-existing liver disease," which is presumably the population of interest here? (*Evidence is sparse.)
I’m a non expert staring at abstracts on a cell phone, but I’m confused as the studies I read indicated that soybean oil emulsions caused liver disease in a large fraction of preterm infants it was administered to. So you’d expect fish oil formula to not do that if it helped, but the studies don’t find a difference. Again, I know nothing about this, but this seems like decent evidence against the massive importance of fish vs soybean
Federal Dementor Association?
I really liked this post, thanks for writing it. Have you done/would you do a post that focuses specifically on how costs are distributed in the American healthcare system? I get the sense that, aside from being monstrously high, our prices are unpredictable and make absolutely no sense for someone paying out of pocket, but I'm never sure how to describe it. Your experience as a provider would surely shed some light.
If Yagmuk and his family can herd moose, they have superhuman powers. So they won't have to worry about the bills.
Thought 1. There needs to be some way of saying "well, ok, maybe it has bad effects in twenty years time, we don't know, but on balance please freaking take it" when the alternative is worse.
In fact, there seems to be a lack of follow up (in all countries) of "ok we did some studies and approved it, now if MILLIONS of people take it, do we detect any downsides?" I know that's hard to do. But we probably need to sooner or later.
Thought 2. Plenty of countries have an approval process for medicine, and provide healthcare in the form of insurance companies, and are nowhere near as screwed as America. I highly recommend a national health service, but maybe looking at what countries more in the middle do and doing that would be a good guide. It's surprisingly easy to forget that as an option
The problem with endorsing untested drugs is not just their lack of efficacy. It's not just the potentially crippling side effects (see e.g. thalidomide). It's also the fact that people who take treatments that they believe to be effective usually stop taking other treatments, which actually *are* effective.
Right now, there are hundreds if not thousands of people out there dying of treatable cancer, because their pastor told them that Jesus will exorcise their disease from their bodies, hallelujah. In Russia, and even in some places in the US, the same is happening with COVID: people believe that good old vodka and a few cloves of garlic will cure anything, COVID included. But those are just regular folk beliefs and established religions. If you abolish the FDA, you will grant pharmaceutical companies; dietary supplement providers; and your local street-corner kook full power to market their miracle cures with impunity.
Yes, I understand that allowing every potential drug to hit the market as soon as possible would save lives; but you must look at the whole picture in your calculus, and the whole picture also includes lives lost or ruined -- which (as is the case with thalidomide) sometimes don't become apparent for years afterwards. Yes, obviously the FDA can be made more efficient, and it should be, but abolishing it would be like setting your boat on fire because you don't like the gas mileage. While you're on the boat. In the middle of the ocean.
Agreed. Good thing abolishing the FDA isn't suggested anywhere in this post.
It is being suggested in a lot of other rationalist places, including be comments here
Are these other places actually other rationalist places, or are they just weirdo ideological libertarian places billing themselves as rationalists? I understand there are some weirdo ideological libertarians here who consider themselves rationalists, but I suggest ignoring them.
I specifically mean LW/SSC adjacent people. one big that comes to mind is eigenrobot on Twitter
I just mean that “this is a real and certainly somewhat well motivated idea people have that I disagree with”
Thinking about Aduhelm and the question of whether it actually treats Alzheimers or just treats beta-amyloid plaques.
Is there a possibility that this applies to some drugs that reduce cholesterol? That they reduce cholesterol is likely true, but that there are no studies showing that the reduction of cholesterol via such drugs actually reduces heart disease? Can anyone point me to some good studies? Thanks.
100% Agree. The system is designed to reward risk aversion, and not just the risk to the public of a dangerous drug getting approved. It's also about their personal risk of making a mistake. No one wants to be the bureaucrat who approves the next thalidomide. So more layers of bureaucracy are added, and along with that comes the inevitable mindset that the procedure is the priority. It's hopelessly broken.
On a separate note, I laughed out loud at the picture of the guy fishing on the ice who burns all the medical bills. That was priceless.
No discussion of FDA intransigence would be complete without a look at the life of John Nestor, https://www.theatlantic.com/health/archive/2012/05/medicines-missing-measure/257901/. I’m surprised he hasn’t been mentioned yet. He spent his spare time causing massive traffic jams on DC-area highways by insisting on driving 55 in the left lane. If an author tried to create an obstinate bureaucrat character based on his life, he would be panned for being too on-the-nose.
Please note: Nestor was transferred to a different role (effectively fired) for not approving ANYTHING in a 4 or 6 year period.
He sued and was restored "with apologies"
https://www.washingtonpost.com/archive/opinions/1999/02/28/nestoring-revisited/798322d2-ee85-48ac-ad5b-3e6fca6dd145/
https://timeline.com/this-man-pulled-into-the-fast-lane-to-drive-55-mph-and-he-pissed-off-all-of-washington-d-c-a55596ca165d
"At the FDA, he was a friend and supporter of his colleague Frances Kelsey as she exposed the side effects of the dangerous drug thalidomide. Informed by her experience, Nestor’s tenure at the FDA was marked by obstructionism. In a four-year stretch from 1968 to 1972, he approved zero new drugs for use by the public, viewing the risks and uncertainties still too great. As a result, he was moved to a do-nothing job within the administration.
He protested, and was later reinstated and given an apology by the agency. "
I love the idea of unbundling permission-to-prescribe from standard-of-care. But standard-of-care is, in practice, set by the courts, right? If the FDA said, "We approve this for use, but we don't want insurance companies to feel obligated to cover it", would that make any difference?
As is so often the case when confronted with what looks like stupidity, the problem is metaphysics. Humans everywhere construct a dichotomy between the sacred or pure, and the earthly or profane. Humans naturally interpret FDA approval as being like the purification rituals performed by a priesthood. And you can't unbundle holiness. It's the most-basic ontological divide, between the temporal and the transcendent.
What I don't get is why the FDA has any power to tell doctors what they can prescribe--and especially why alleged inefficacy should justify banning a drug's use. The reason for our heavily-regulated system of educating and licensing doctors is to ensure people can trust licensed doctors. We trust them to cut us open and sew us back up, and to keep up with recent research in their field (even though many don't). These things are simple and objective compared to drug approval. The literature on any particular drug's safety is always contradictory, the studies are mostly fatally flawed, the committee doesn't have time to read the literature that took years and hundreds of millions of dollars to produce, and the ultimate decision is often based on the helpful "summary" of some industry flack.
(Also, it's rare even for drugs that fail the safety tests to be as lethal as tobacco, alcohol, or sugar.)
who do you think is standing in the way of viagra or a zpac being available OTC?
First, I don't see why you'd object to viagra being available OTC. Second, what I wrote has nothing to do with things being OTC. I believe that doctors should be able to prescribe drugs that haven't been approved by the FDA. Probably none of them WOULD, but they should be allowed to.
I agree wholeheartedly. My point, I guess poorly conveyed, was that the doctors are a huge part of the problem, and they have the easiest ability to fix it. but they wont, and theyll continue to keep the cartel on medical treatment in tact
An anthropologist might put it this way: In the US, new drugs are taboo until they've been ritually purified by FDA approval.
psychiatrists do this cost/benefit every day with patients with less risk/recourse than any politician and still make the same decisions. maybe change should start there first
actually its worse than that, the FDA has approved treatment and insurance would cover on any number of psychiatric conditions but the doctors won’t actually do it. covid wouldnt be any different
BRUTAL: "Although the FDA did kill thousands of people by unnecessarily delaying COVID tests, at least it also killed thousands of people by unnecessarily delaying COVID vaccines."
July 8, 2021: Joint CDC and FDA Statement on Vaccine Boosters | HHS.gov
Americans who have been fully vaccinated do not need a booster shot at this time. FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary.
https://www.hhs.gov/about/news/2021/07/08/joint-cdc-and-fda-statement-vaccine-boosters.html
August 5 2021:FDA Covid-19 Vaccine Booster Plan Could Be Ready Within Weeks…
The Food and Drug Administration expects to have a strategy on Covid-19 vaccine boosters by early September that would lay out when and which vaccinated individuals should get the follow-up shots, according to people familiar with discussions within the agency.
https://archive.is/Lxmdq
Seems to be a remarkable turnaround. NBC news had to contact each state to get breakthrough data since the CDC no longer reports on breakthrough deaths and infections:
https://www.nbcnews.com/health/health-news/breakthrough-covid-cases-least-125-000-fully-vaccinated-americans-have-n1275500
CDC Scaled Back Breakthrough Case Hunt Just as Delta Grew
https://archive.is/Zgnme#selection-1459.0-1459.57
What am I supposed to take from this?
Publicly, they say that boosters aren't needed.
Internally, they are discussing the schedules for boosters if needed.
Sounds good to me.
(WHO has called for no booster shots while the rest of the world still needs their first shots.)
I’m still stuck on facts of global and American drug development: more new (and effective) drugs get invented in the USA than anywhere else. Every proposal to radically change the way the FDA or any other part of the ecosystem represents implicitly a claim of this nature: “I see the greatest production system for drugs the world has ever seen, and I know how to do better.”
In other contexts we know that imposing strict rules and forcing people to play a somewhat arbitrary game is often a spur to creativity, because it enables direct comparison of things. In medicine, those arbitrary rules look horrifying because they are arbitrarily obstructing people’s access to healthcare. But the gamification seems to be working. Tweak the game, sure, but removing a major plank of it seems reckless.
I think you're ultimately correct, that the FDA's mulish nitpickery has some role in the creative process, and only a fool would want to go back to the 19th century heyday of snake oil medicine, in which sensible and workable therapies were drowned out by a flood of P. T. Barnum mockeries. Crap can certainly drive out good, as we see in how spam has nearly killed e-mail communication, and how trolls can ruin a discussion board. Imagine the same world of spam and trolls dominating the world of medicine and therapy, and trying to defend yourself against *that*. Brr.
That said, I think a better argument for the mainspring of American drug development can be made for the massive American market, the willingness and ability of Americans to pay enormous sums of money for the best possible health outcomes, and the large and very successful American university graduate education and research system in biology and chemistry that produces the basic research insights.
Yes, I don't think I have any meaningful counterargument to that - I'm not sure anyone does. The kind of economic analytical power it would take to pick apart those factors goes beyond anything I've ever seen. I feel like Europe, Japan, and now China have money and decent universities and a desire to live. But from what I understand, they can't touch the USA for drug development.
So I'm just left with a feeling, based on personal anecdotal experience, or gut, or whatever you want to call it. My feeling is that of all the factors that limit drug production, scientific rigour is the most difficult to achieve. So any move that feels like it's away from scientific rigour sets off alarm bells. In the long run, pace the horror stories, I can't see how less rigour could possibly bring us more drugs.
Scott's story of the fish oil is striking - just relax FDA regulations, and we could add fish oil! But I don't think it's right. Just relax FDA regulations, and you'll get 20 companies telling you to add snake oil and mongoose oil and oil of olay. If the fish oil company even exists any more, it'll be drowned out by the noise.
Yes, I think that's a good point. I think people tremendously underestimate the stress, cost, and painful mistakes that would be part of dealing with a world in which there was a much lower level of enforcement of rigor in drugs, because we're more than a century removed from that world. That's why I mentioned the idea that the role of spam and trolls in online communication might be similar -- most people are old enough to realize these things have ruined many aspects of the Internet that *seemed* at the time to be a glorious avenue for the spread of knowledge and useful communication. Social parasitism is a thing among our species, unfortunately.
By the way, I don't mean to imply the Europeans don't do first-class drug development work, they do. There just isn't as much money floating around over there, for the most part. Asia is another story: I think the Asians are starting about 25-50 years behind Europe and the US in terms of their development of their biology research efforts. The Chinese in particular feel like they're living in the US of the 1970s and 1980s, when the cool new thing was space travel and computers. They don't seem fully aware of the exploding possibilities in biology.
> So the long-term solution is to become a different kind of country and different sorts of people
The simplest way to do this is to break up the United States into several smaller countries. The amount of problems this would solve is truly huge.
Hm, maybe they could still retain some sort of overarching cooperation on big issues, like foreign policy and a military and stuff like that that's hard for a smaller country to do alone as effectively. You'd have to watch out so that organization doesn't get too big for its britches and try to force the laws of the individual nations to conform to the mores of the inhabitants of a single small nation who disproportionately administer the cooperation, though.
If you look to existing countries outside of the United States you can see that that doesn't happen in practice.
"outside of the United States"
I think you missed the secret, hidden message of my post.
After reading over it a few more times I now think you really *are* referring to the EU. I suspect you and in the US and to you it looks like countries like Germany and France are small, but to me, a New Zealander, that is a very difficult conceptualisation so I missed it.
What do we do about all the corporations that currently function via the relatively uniform United States law and commercial code and political situation to deliver services and products and stuff to people from west to east coast? Why would seceded Iowa or TX have a good FDA given the current mediocre state of their state bureaucracies? Or if you’re a lefty and not a rightoid like I guessed, why would seceded CA have a better FDA given it’s mediocre stuff? And what about the other guy, are they abandoned to the miseries of their own designs?
But every developed country smaller than the United States already has a better FDA regime than the US does so, um...
Breaking up along state lines would be a pretty bad idea, although still better than the status quo; breaking up along natural geographic and demographic borders would be ideal.
Smaller countries have better governance because the leaders are less insulated from the people they govern, they have more skin in the game and it's harder to get away with shoddy bureaucracy.
On balance I'm a centrist, if the people from both sides aren't both winning then the policy isn't good enough.
> But every developed country smaller than the United States already has a better FDA regime than the US does so, um...
No? The review someone posted to show this actually found the US had the third lowest time to approval - which, considering the US lets everyone mooch off them for drugs and data, is super good - https://astralcodexten.substack.com/p/contra-drum-on-the-fish-oil-story/comments#comment-2567516
And when a country makes an attempt to speed up their approvals to beat the US, https://astralcodexten.substack.com/p/contra-drum-on-the-fish-oil-story/comments#comment-2571594 - maybe it doesn’t look good
Well I personally don't think of China as a developed country and I don't necessarily think those figures disprove my point as the US approvals still cost way more than the others (and the cost is seemingly the main reason for the fish oil based nutrient taking so long to be approved), however these figures are a lot closer than I would have thought which makes me a lot less confident in my original statement.
The lack of early testing really seems like the greatest failure here, but there's also the shamefully poor quality of publicly available information. This is supposed to be the age of big data, but the federal government is such a shit show that we can't even get properly detailed demographics for deaths from covid, let alone infections or hospitalizations. There is no rational excuse for why I don’t have a more detailed risk profile than the “official” (non-standardized) overly broad age ranges and a vague list of comorbidities. This uncertainty makes me skeptical of the whole situation and I have to wonder to what degree mass hysteria is playing a role.
Sure there is. The Federal Government doesn't *generate* the data, it merely collects and stores it, and makes it available. The reason you don't have amazing data on COVID is because the people who would have to generate it -- the front line hospital staff, physicians, RNs, coroners -- are all frantically trying to save the living right in front of them. They don't have that much time to spend after a 12-hour shift of nonstop care to be carefully categorizing and labeling the dead, and filling out some complicated or oversimplified form and sending it up to the Feds for the eventual use of people like you. Bear in mind nobody on the front line is *paid* for doing any of that reporting work, either. They usually do it eventually, and it makes its way slowly to the right place, but it doesn't come fast, and it doesn't come as complete as you might like, because somewhere along the way some (in hindsight) useful demographic information (age, sex, race, location, pre-existing conditions) gets omitted or lost.
If you want to change that, then by all means write your Congressman and suggest that the Feds give out major grants to all the hospitals in the country for paying medical staff to fill out mortality reports in detail, and quickly and completely, and sending them on up to the government. We would probably also need a well-designed and robust IT infrastructure to collect the data much more easily and reliably, too, and (remembering the Obamacare website fiasco) that probably means another major grant to build such a system. All of this sounds like it will cost a nine-digit number of dollars, so you probably need to be prepared to say from which other government spending priority you want the money taken, or how you want your taxes raised to pay for it.
I’d happily support a tax increase for much better medical data and medical data sharing. But it’s definitely more of a structural challenge than a budget one - there’s plenty of data filling and technology already, it’s just not super duper great especially in the aggregation and presentation. I think people are working on it too! In particular the state of it currently is quite bad iirc, hence OWID and stuff being de facto sources when something in the govt “should” have been collecting and presenting it
Sure, I'd support it, too, although I don't think there's any need for a tax increase, as I have no problem pointing to several hundred $billion of Federal spending that I would already cut, and a small fraction of which could be redirected to this useful purpose. One of the few things government can do that is pretty uncontroversially and obviously good from nearly any political viewpoint is to collect good data and make it widely and freely available.
>The Federal Government doesn't *generate* the data, it merely collects and stores it, and makes it available.
But much of the data we need, is data the Federal Government *could* generate, and at relatively little cost. To know, e.g., whether we need to close down elementary schools, we don't need data on every schoolchild in America. It would suffice to pick a dozen or so schools that for whatever reason haven't closed down in spite of local community transmission, collect and analyze detailed data on those students and teachers and their immediate family members. That could be done by parachuting in a few CDC test-and-trace teams, without substantially disrupting local medical personnel.
That could have been done over a year ago. That would have been incredibly valuable data to have had a year ago. And it isn't just the CDC that's to blame for that one, because any of the larger state health services could have done it just as well. But none of them did,
Well, sort of. The Federal Government doesn't actually maintain the staff needed to do such a thing. They usually just hand out grants to *other* people to do research like that, and of course the whole grant-application thing is fraught and takes a long time. I expect plenty of grant applications *were* submitted, and the alphabet agencies have probably already approved a bunch and studies are gearing up as we speak. Sometime in 2025-30 we'll have some answers.
That isn't entirely cynical, either. If we want the government to have crack investigative teams standing by all the time[1] it would cost a bundle, and how often would we use it? Nevertheless, it's a serious question about which we might be well-advised to think.
-------------------
[1] https://www.youtube.com/watch?v=rgDmJzaSd40
You are wrong about one crucial fact in your argument: neither public payers nor private insurers have to cover any given therapy. Surely you could have just checked with a drug rep friend? One of the huge headaches for pharma, patients, and physicians is that medications with better efficacy, safety or tolerability often require days of paperwork hurdles or are simply not covered.
There is no requirement that payers cover approved drugs. Period.
In fact, this fact probably results in tens of thousands of deaths. When a patient with fulminant acute leukemia cannot get immediate treatment because the paperwork takes three days, he or she often dies in the interim.
My sister has a glioblastoma. She took one anti-seizure medication which left her so tired she couldn't function. Her insurance company refused to authorize a different medication until she and her doctor stumbled on the magic formula: she had lost her appetite. Crazy.
Your argument falls apart if it is based on that faulty premise.
"By March 1, China was testing millions of people a week, South Korea had tested 65,000 people, and the USA had done a grand total of 459 coronavirus tests. The pandemic in these three countries went pretty much how you would expect based on those numbers."
When I look at China's numbers the only thing I'm pretty sure of is that there's no way they represent reality. Do you have some reason for giving them credence here? Either on the testing front, or on the course of the pandemic?
It’s consistent with how they’re managing it - large scale testing and restrictions when spread is detected. They would need a lot of tests.
The public graph of cases over time from China is not consistent with reality, possibility, rationality, or epidemiology. I don't even need to find a specific one to prove my point; they all do.
The depth of China's lies about how they have been impacted by coronavirus swamps any meaning we could hope to draw from their story. When we can't possibly know how bad their situation is, or how many people have caught it, out how many people have died, it is ridiculous to hold them up as an example of what to do right.
I haven’t looked into it very well, and sure they may have fiddled with cases and probably did given they fiddle with literally every other statistic. Nevertheless they appear to have managed it somewhat decently, and are in fact mass testing and continue to because their vaccines don’t work so well, and are doing sporadic lockdowns to control emergence based on those tests, and like the citizens do report being frequently tested, and other East Asian countries have also had success with test and trace and sporadic lockdown, so then testing a lot is believable.
The only half-serious attempt I've seen to look at second order effects and try to predict how badly China was impacted estimated 8 figures of deaths in China within the first half of 2020. Their primary state telecom company reported something like a 15 million subscriber decrease in just Jan-Feb 2020, which was quickly "adjusted" a day or two later.
Do you have evidence to support your opinion that all that occurred with the statistics was "fiddling"?
Go to any aggregator of repute, pull up the case or deaths history from any 6 countries in the world including China, and tell me what reasonable conclusions we can draw about how they're managing it.
Or, for those of you who just want to click a link and see...
https://ig.ft.com/coronavirus-chart/?areas=usa&areas=bra&areas=ind&areas=hun&areas=chn&areas=can&areasRegional=usny&areasRegional=usca&areasRegional=ustx&areasRegional=usco&areasRegional=uswy&areasRegional=usfl&cumulative=0&logScale=0&per100K=1&startDate=2020-01-01&values=deaths
"Around 2010, Boston Children’s Hospital found some loophole that let them add fish oil to their nutrient fluid on site, and infants with short bowel syndrome at that one hospital stopped getting liver damage, and the FDA grudgingly agreed to permit it but banned them from distributing their formulation or letting it cross state lines"
So why couldn't all the other hospitals simply apply the same 'loophole'? How difficult was it to figure out the formaulation?
Great now I'm depressed
> So when I talk about unbundling FDA approval, I mean that instead of the FDA approving the following bundle of things…
Or you could push for universal healthcare so that what insurance will cover isn't under FDA's purview at all, so you're just left with the 1 responsibility.
So what is and isn't covered is determined by which political party controls Congress? Whether you get a kidney transplant or live in thrice-weekly dialysis for the rest of your life is determined in the same way Congress decides on Amtrak or Post Office subsidies, or whether to pay SpaceX or Boeing to build heavy launch vehicles, with all the associated politicking and lobbying?
You'd think any Republican who lived through the election of 2008, and any Democrat who lived through that of 2016, would shudder in horror at that prospect.
You could speculate along these lines, or you could read about how every real health care program around the world are run responsibly.
Well, that would be a good argument if I *agreed* every nationalized healthcare program around the world were run effectively and humanely. But I don't.
No doubt are poorly run ones from which to learn. But are they so poorly run that they're worse than >10% of its people literally having *no health care at all*? Are they so poorly run that they lose their health care if they lose their job, even in the midst of a pandemic?
In what First World country do 10% of the people have no health care at all? Certainly it's not true in the United States. Go into any big-city ER, and you will see a flood of people, often 80% or more of the patients, who are receiving first-class medical care for everything from a broken arm to metastatic lung cancer, and who will never pay the bill. It is not legal in any state for a hospital to decline to treat a patient merely because he cannot pay, and so they don't. (This is one reason medical care for those of us who can and do pay is more expensive, of course, we subsidize the healthcare of those who pay nothing.)
Moreover, every state in the Union has an indigent healthcare insurance program. If you're poor enough you can get on Medi-Cal in California, for example, and have a decent (if not luxurious) healthcare plan that covers routine exams, sniffles and infections, major trauma, even kidney transplants. And the net cost in premiums might easily be $0/month, courtesy of the taxpayers.
It's certainly correct that the current US system of employer-mediate healthcare insurance is stupid, but that is a legacy of Democratic tax law policies designed to satisfy their major constituency at the time, labor unions, which negotiated extremely generous healthcare plans as a form of secondary compensation (including post-retirement) but didn't want them taxed as ordinary income. So we have this idiot system where it is far cheaper to buy insurance through your employer than on your own, simply because of the tax law.
But it hardly dooms a person who loses his job to losing his insurance. COBRA allows you to maintain it for a while, although you have to pay the full premium, which is a shock for most people, and there *is* an individual market for healthcare plans, although it's not as good as the employer market. These are giant pains in the ass, and for some unlucky people seriously painful -- but, you know, losing your job necessarily is painful. You often lose your house, too, and your retirement savings, and they can repossess your car and all kinds of nasty stuff. You might find yourself having a hard time paying the heating bill (in winter), or buying enough food. It's not obvious to me why healthcare insurance should be some very special category of thing that joblessness should not touch at all.
> In what First World country do 10% of the people have no health care at all? Certainly it's not true in the United States. Go into any big-city ER, and you will see a flood of people, often 80% or more of the patients, who are receiving first-class medical care for everything from a broken arm to metastatic lung cancer, and who will never pay the bill.
Yes, I'm speaking about the US, and those people in the ER that have no insurance and can't pay are there out of desperation; they don't get healthcare for the vast majority of the ailments they suffer in life except those emergencies for which they simply must risk bankruptcy. Scores of documented examples of this.
> It is not legal in any state for a hospital to decline to treat a patient merely because he cannot pay, and so they don't.
Technically correct for "emergency" conditions, but often incorrect in practice for common healthcare needs, and those patients are also then saddled with absurd and fictious bankruptcy-level bills.
> It's not obvious to me why healthcare insurance should be some very special category of thing that joblessness should not touch at all.
Not being healthy inhibits your very ability to address literally any other concern. This is not the case for being jobless. Losing "stuff" is simply not the same category of problem as losing "health".
I feel like you're bordering on being disingenuous in your descriptions of US healthcare. The inefficiencies and failures are well known. Yes a national healthcare/single payer system will also have failures, but nowhere near as extreme, nowhere near as widespread and nowhere near as costly as what the US currently has in place.
Right now Medicare is forced to cover whatever the FDA approves, so if the universal healthcare was Medicare For All or some equivalent, it would be too.
Fascinating.
A thought on the star-system - would it make more sense to split it into two sets of ratings?
One representing "confidence that the drug does the (desired) things it says on the label" (A wording chosen to step around off-label/novel uses), and one representing more or less "confidence that all the side effects are on the list of known side effects with risk factors and incidence rates reflecting reality".
I would prefer this split because the single-set system as proposed (at least as I read it) interacts weirdly with, for example, drugs with likely awful side effects that are less bad than what they treat - for example, in a sense at least, a really good five-star chemo drug is less safe than a two-star sugar pill.
That said, it's possible that by "the drug is safe" you mean "we are very confident we know the side effects and risk factors for them"...
Source for "the only reason we can get these at all is through provisional approvals that they wouldn’t have granted without so much political pressure," please?
Scott's dismal assessment of the FDA's incompetence tracks the narrative told by Michael Lewis, in Premonition. The root cause is obviously the dysfunctional incentivize structure inherent in any political bureaucracy. This follows the entire body of microeconomic theory and empirical research, which uniformly stands for the proposition that bureaucrats following their own interests will **always** get the cost-benefit ratios wrong.
Scott's idea of provisional/scaled "approval" levels seems like a great reform. Another reform that might be useful, however, would be to have an entirely independent and alternative path to go around the FDA when it is dragging its feet unnecessarily. Perhaps this consist of some association or jury of specialists in the particular field that could vote to at least allow certain especially qualified members of their specialty to provisionally prescribe the medicine based on an individualized review of the safety/efficacy data as it exists, as compared to a patient's individual risk/benefit circumstances. (For example, a patient who is about to die without the drug, or a patient who is highly unlikely to have potential side effects). This clinical experience could also be monitored and folded into the overall case for and against the drug.
A guess a question for Scott would be how to get a real reform process started in light of the entrenched incentives? But I guess that is always the big question.
As a side note, the bad reporting of the Atlantic seems typical of how the "prestige press" seems generally incompetent to analyze any issue that involves hard technical and economic issues. They usually just aggregate banal quotes, talk around the issues in verbose prose, and then conclude with how "these are complicated issues," people are "trying hard," and "doing their best," but really smart "experts" are on the case and aware of the issues, so they'll keep all this in mind and hopefully do better going forward, blah, blah, blah.
I really like your idea of a more fine-grained rating system for the FDA but I think your single dimension star-rating system in combining two important dimensions: safety and efficacy. The FDA should separately report safety and effectiveness.
Something that may or may not work but is not dangerous may still be worth taking for many people.
Something that definitely works but is also dangerous could still be worthwhile for a different subset of people.
Drug ratings for pregnant women have a similar problem with their one-dimension rating system. Drugs in class C may be safe but with unknown effectiveness, or they may be effective but dangerous. The difference is important to know.
Great article! It feels a bit like the FDA is robbing me of my life. The government is blocking one of the most important things in life, my health. Why are we allowing govt to force what my doctor and I can and cannot use as treatment? If I’m willing buy a drug from a company that’s willing to produce and sell that drug then it’s in my best interest to work with my doctor to decide what’s best for my life. The FDA would be greatly improved if it’s role was simply to protect citizens from false claims (ie: if a doctor or drug company lies to me in order to get me to use their treatment)
That's actually all they do. They just say "in our opinion this works, and this doesn't." The problem is that as soon as they say "this doesn't work" your insurance company says "oh in that case we won't pay for it" and your physician might say "well hell I'm not going to prescribe it because I don't want you suing me for malpractice."
But it you were rich enough that money was not a big problem, I am pretty sure you could find a physician somewhere who would prescribe anything that wasn't flat-out illegal according to the rule of the state in which you live, and you could pay for it yourself, and then the FDA's opinions, for you, would indeed be merely advisory.
Thanks for the reply! It got me doing more research… the FDA’s own website says “New drugs and certain biologics must be proven safe and effective to FDA’s satisfaction before companies can market them in interstate commerce.” I’m still pretty sure if I created an affordable $5 covid test, I’d still need to be approved by the FDA before selling it to you otherwise I’d be in trouble with the law. I think that’s also what AstralCodex is pointing out in the article.
Book review request: Upton Sinclair's "The Jungle," would be interesting to see what the pre-FDA world looked like (from the perspective of what I can only imagine is the early 20th century equivalent of a quirky rationalist blogger), and whether there's a reason for the madness.
The most important thing about "The Jungle" is that it is a work of dramatic fiction, not reportage. The story seems to have been built the same way Mike Daisey constructed his story on Foxconn working conditions - a reporter briefly visits a location, collects the most disgusting stories anyone he can find there has heard of or invented no matter how outlandish, makes little attempt to confirm anything, adds an additional layer of exaggeration "for dramatic effect"...and pretends to be reporting on real life as personally observed.
Scott, if you haven't seen it yet, Matt Yglesias also wrote an essay on the FDA situation (two weeks ago; not subscription-locked), and I think it complements yours quite well: https://www.slowboring.com/p/fda-cost-benefit
CNN interview of Walensky was removed by google. It is now on rumble:
CDC Director Rochelle Walensky stated the vaccine does not prevent COVID-19 infection, nor does it stop the vaccinated person from transmitting the infection or the delta variant. According to Director Walensky, the only benefit from the vaccine now is presumably that it reduces the severity of symptoms.
https://rumble.com/vkscco-cdcs-dr.-rochelle-walensky-admits.html
Hospital patients could be at risk:
'Physicians, nurses, ancillary staff': How hundreds of SFGH and UCSF staff got infected with COVID
More than 230 staff members are infected with COVID, most of which are breakthrough cases.
https://abc7news.com/coronavirus-outbreak-san-francisco-general-hospital-sf-covid-ucsf/10920805/
I just Tweeted a thread with some overlap to this post, including a rec for a good podcast interview with a former FDA person who argues in favor of the Aduhelm approval and the use of the accelerated approval mechanism of the FDA, plus my comments on why that will be good for the aging/longevity space and in particular that the chance of using an aging clock as a surrogate for approval via the accelerated (conditional) approval + phase IV trial mechanism may be fast approaching as it is likely one of these clocks will outperform Abeta in AD prediction soon. See: https://twitter.com/KarlPfleger/status/1423774160321490950
The biggest concern right now?
New coronavirus variants could be named after star constellations once letters of the Greek alphabet are exhausted, a senior World Health Organization official has suggested.
In an interview with the Telegraph Maria Van Kerkhove, the WHO’s technical chief for Covid-19, said the UN health agency was already looking at new names for mutations amid fears there will be more concerning variants than the 24 letters of the Greek alphabet.
https://www.telegraph.co.uk/global-health/science-and-disease/variants-could-named-star-constellations-greek-alphabet-runs/
Medicine is too complex for a uni-dimensional "star" system. FDA should strive for clarity, not simplicity. State what we know, without messaging spin. Others can do the messaging. Be a source of truth, without taking responsibility for all the knock-on effects. Sharpen the blade; don't dull it in the vain hope of improving system-wide outcomes. That's the only way to develop a stable reputation.
From nintil-
The FDA approved an ineffective drug for Alzheimer's, aducanumab. Scott Alexander has a post on it, including a broader discussion on whether the FDA is too lax or too conservative. The right answers is that it is both; Scott doesn't discuss oncology, where arguably it is too lax, enabling multi-million dollar biotech grifts to exist. Scott's framing is puzzling; why "pulling the FDA level" towards being more lax when one can propose both tactically based on cost-benefit analyses. Anyway, the solutions he discusses later are good and go beyond the FDA: the reason we ultimately care about the FDA approving useless drugs is that the US healthcare system will pay for them. That has to change: The FDA could switch to a multi-tiered level of approvals and Medicare should be decoupled from the FDA so that they don't have to cover all drugs coming out of FDA approval. Here's a critique of some of the points that Scott makes.
https://willyreads.substack.com/p/slightly-contra-ssc-on-aduhelm
Again recommending willyreads substack it is great
Liked the article all except for this blurb that makes it seem like there is absolutely no reason not to get a covid vaccine:
"this policy has led to our current situation, where either everyone has to be miserable because of stupid people’s choices (eg everyone has to wear masks forever because a few people won’t get vaccinated) or we get a strong anti-freedom lobby because allowing anyone any freedom means that the rest of us have to suffer for their stupid choices."
There is a 3rd option - which is to let the vaccinated people be protected, and the unvaccinated people live-out the consequences of their choice. In reality a cost-benefit analysis would tell you that there is almost no benefit to anyone for healthy people under 40 to get vaccinated. For older people and people with other risk factors the vaccine is by far the best thing they can do to protect themselves.
What is the justification for the FDA to exist at all? Surely we'd be better off without it.
I know it's like a year later, but here's a Science article - https://www.science.org/content/article/potential-fabrication-research-images-threatens-key-theory-alzheimers-disease
Lesné's work is the basis of all the beta-amyloid work (which this drug is based on) -
A quote - "A 6-month investigation by Science provided strong support for Schrag’s suspicions and raised questions about Lesné’s research. A leading independent image analyst ...reviewed most of Schrag’s findings at Science’s request. They concurred with his overall conclusions, which cast doubt on hundreds of images, including more than 70 in Lesné’s papers. Some look like “shockingly blatant” examples of image tampering, says Donna Wilcock, an Alzheimer’s expert at the University of Kentucky."
So, there you go.