Early on in the vaccine rollout, there was a debate over whether or not we should split up the vaccine shots by a little bit more to double the number of people who were vaccinated. This ended up not materializing, because by the time the public had any kind of opinion on it the supply issue had already more or less been resolved, making this unnecessary.
With that said, I can't help but think an opportunity was probably missed there. All the early studies I saw suggested that getting only one shot of the vaccine confers about 85% of the immunity acquired with two shots; instead of being 95% effective, just one shot of the Pfizer vaccine would be 80% effective. While a considerable drop, this still put it significantly ahead of the J&J vaccine on your first shot. I am inclined to think we could have doubled the rate of the early rollout, but because of the issue you discussed at the end we opted not to.
The likely reason the CDC decided against this option was because there was no solid public opinion on it, and it would have probably bothered those who had already scheduled their second shot appointments. But that's bad grounds for making public policy. They should have done what would end the pandemic the fastest, and that would have been splitting up shots and doubling the speed of the early rollout.
The political climate in which we exist has created an atmosphere where public officials in government agencies are afraid of the political repercussions of acting and while the most obvious example of this is with the CDC, I can't help but think this likely plagues the top levels of all government offices, whether that be the FTC, DOJ, ATF, and so forth.
So are you saying the reason the FDA might be a month slower in giving full approval to Pfizer is because Pfizer isn’t lobbying them hard enough? Did you actually answer why the process is slow, or did I miss it?
I honestly don't know what the FDA approval process means during a time of a raging pandemic. The EUAs have led to 340 million shots administered, and counting. Given that, could you imagine the FDA deciding to pull the EUAs and tell everyone that getting the shot is a bad idea and potentially dangerous? And while "everyone" knows already that the vaccine is safe and should be approved today (heck, that's how I feel), someone has to be in charge of looking at the data in a systematic, objective, scientific way; that's why we have the FDA rather than counting up Twitter votes.
Except that, with 340 million shots in people's arms, it's really too late for a systematic, objective, scientific examination of its safety and effectiveness; the die has been cast. So, just go ahead and approve the damn thing. Like the Fed in March 2020, if everything turns out fine, no one will be complaining about the FDA's shortcircuiting of the process and not behaving in the most objective, rule-bound way.
I just want to point out that the requirements for data indicating safety and efficacy aren’t less stringent for EUA than for a traditional NDA, so the FDA actually already has the data they need to approve.
What makes the EUA different from the NDA is just that you can start manufacturing while the EUA application is in review, and EUA applications jump to the head of the review queue. That’s it; the “process” here for full NDA approval of the vaccines is just that now they don’t jump the queue ahead of boner pills and statins.
This is a pretty minor nit, but it still bugged me. Regarding Canada's one-shot strategy, MY writes: "But then you can see how first shots first worked by looking at how they caught up to and then surpassed us."
That's not why Canada is passing us by. It's because we ran out of people who wanted to get vaccinated. We hit a peak of 3.7 million shots/day in mid-April; we're under 600,000/day now. If we were populated by Canadians, we'd have a lot more vaccinated people now.
FDA-er here. The critique here is absolutely spot-on - I'm gob-smacked by how Matt has lined up the relative issues and weighed the subtleties (with one exception, mentioned below). What to do about it is much less well-developed. FDA is an enormous ocean liner; it can't change on a dime. Changes like these take years and are likely to produce all sorts of unintended consequences.
The point that is missing from Matt's analysis is that once a product is approved, it can in most cases be legally used in any way a medical practitioner sees fit. If Medicare or other insurers want a cost-benefit analysis to pay for a given use (particularly if that use is not FDA-approved), they can do it themselves. If it is useful from a public good standpoint for some disinterested party to do that analysis, the best model is to create an agency designed for that purpose like NICE in the
UK.
More importantly, the prospect of a NICE-type agency is anathema to the health care industry. Congress has regularly kneecapped AHRQ, the agency we have that is closest to NICE, whenever it began to take this subject seriously. There is less chance of FDA, Medicare, AHRQ or some other agency creating a sound cost-benefit framework than there is of CDC studying gun violence as a public health problem.
How much do you think that the FDA's decisions on breadth or narrowness of a drug's indication impacts all this? Obviously off-label use is rampant, but narrower indications do help commercial payors limit coverage.
The decision on breadth or narrowness depends on the studies used for approval. The drug company takes a calculated risk: if they test too broad a range of patients it may drown out evidence of benefit in a subgroup and you can't pick out a subgroup post hoc and say, "hey it worked for them" (you would have to do an additional study where that group is identified prospectively). If they test a narrow group, they get the indication for just that group and are not allowed to market it more broadly. Although there may be a whispering campaign encouraging broader use, they can get in big trouble if they are found to be behind it and the commercial payers do push back against this.
Whether a drug provides enough benefit to merit approval and its pricing are related but separate questions. FDA approval gives license for companies to set prices based on the FDA approval -> CMS coverage -> payor coverage and payment equation, as MY states. I don't think that FDA consideration of pricing would improve their decision-making; better would be to allow Medicare to play a negotiating role. Also, it's not a pure free-for-all. Commercial insurers choose what formulary status to give a drug. Whether a drug is covered as first-, second-, or third-line therapy by insurers has a massive impact on sales. Drug companies will generally reduce prices if they fear being assigned second- or third-line formulary status. While the resource-allocation mentality of international regulators probably does lead to different drug evaluations, it doesn't suggest making the FDA think about economic cost-benefit analysis. The UK cost benefit work is done by NHS when it decides what to cover and what to pay. That is totally distinct from the drug approval, which has been done by the European Medicines Agency (but will change to the UK post-brexit).
There are good questions as to whether the FDA could be better at weighing the medical cost-benefit of each drug it evaluates. The agency weighs these differently across different disease states and therapeutic classes. Partly this is because it relies on experts in each field (oncology, infectious disease, etc.) who bring their own biases. But patient groups, institutional bias, play a role. Some are criticizing the FDA for being risk adverse to prior failures, but is that really unfair? Wouldn't we want them to tighten standards when they find that previous standards led to ill effects?
What I most wish for is a bit better judgement from FDA. They are strict about trial protocols because there is a long history of drug companies post-hoc digging for statistically-significant findings to support claims (p-hacking their way to coverage). The FDA is right to guard against this. But then they apply this to the AZ vaccine trial, where the issue is completely different. Ultimately we have to trust regulators to exercise good judgment.
"There is a very strong presumption among public sector entities that you cannot mandate a vaccine based on an EUA."
On what is that very strong presumption based? Does it come from the FDA itself? Why is the problem not with the presumption (or whatever it is the presumption based on)?
I can only speak for military members but in that case it’s illegal. The historical reasons for this are due to the government literally experimenting on military personnel. So the FDA either needs to approve the vaccines or Congress needs to change the law.
A few weeks after saying that the CDC shouldn't be doing cost benefit analysis and just putting out the science, you're arguing that the FDA should. This is wrong.
The FDA should be approving drugs. For an amazing vaccine, perhaps accelerated full approval makes sense, but unfortunately we have a frequentist rather than a bayesian org. (Your/Rosenthal's critiques of the FDA approving marginally useful expensive drugs is on point, but not useful for the EUA argument).
The CDC is literally there for *Control*. It should be responsible for doing what is required for controlling epidemics.
Critically, I think, this is the question. What if we had only Sinopharm or some other much more crappy much more side effect ridden vaccine? In a pandemic would *still* want to require everyone to take it. The value to the country as a whole is worth much more than the individual side effects. Once the pandemic is under control, you wouldn't want the vaccine to be used though.
To do this, in the "FDA cost effectiveness model" you'd want the FDA to approve it, and then disapprove it. This makes zero sense. The FDA doesn't even have people thinking about epidemics. The CDC, on the other hand, does have a lot of people thinking about epidemics, and should be capable of requiring a vaccine for the greater good in an emergency.
The problem is the politics - as soon as you're past the emergency, once there is no pandemic, especially if you start vaccinating early and the pandemic doesn't happen (as would be ideal) then the people who did have the side effects from the crappy vaccine start feeling quite grumpy about the whole thing.
And that's why we can't deal with an emergency. The problem is us.
Learn something new! Thank you, I stand corrected. Based on what (Wikipedia says) the FDA does vs. the CDC I'm not sure I understand why. I mean, sure, to issue an EUA you have to know you have an E but surely other orgs know this? Is this just the FDA taking over part of the CDC's job?
One reason is that the FDA is more “muscular” than the CDC - I work in food, so if there’s an outbreak of Listeria in (say) ice cream, all the CDC can do is recommend that retailers pull the ice cream off the shelves and that consumers check their lot numbers and throw it away.
The FDA can actually force a manufacturer recall, force a contaminated plant to cease operations, seize and destroy affected foods, and even pursue prosecutions of company executives who acted with disregard for food safety practices to the public’s detriment. Much of that authority stems from the E coli poisonings in hamburgers (Jack in the Box) from the 90’s. I actually knew a guy whose girlfriend was in a coma for a while due to a hamburger-related E coli infection.
And of course since it’s inception the FDA has had the power to interdict the sale of food and drug products that were dangerous to public health. The FDA is a regulator; the CDC’s role is primarily in study, surveillance, and public health control of diseases. But the CDC either needs your permission or a court order to come onto your property and treat a mosquito swamp; the FDA can do it on its own authority provided you’re a facility the FDA regulates.
"Biden's CDC has done the right thing — they say true things about public health."
You're right, it's a little hard to tell exactly what Matt thinks the CDC should be doing here, but it looks like model based recommendations isn't it.
I thought Matt supported the CDC reporting out facts as they know them and letting elected officials and the populace decide on how to change/not change their behaviors based on those facts. For example, I thought Matt believed that the CDC should have been upfront about the benefits of masking right away and not have engaged in a cost-benefit like analysis in opting not to recommend mask wearing to preserve PPE for frontline medical personnel.
Cost-benefit analysis sounds great until you disagree with the decision makers' weighing of the costs and benefits.
Given the context in which he said it, he didn't seem to think the CDC not doing cost-benefit was a bad thing. Rather, he suggested it is something people should be aware of and act accordingly with respect to CDC guidance.
It seems like a cost benefit analysis would get very complicated and political very quickly. Should the FDA account for the lifetime economic value of second graders getting one year of in-person learning? We have no basis for measuring that. Should they estimate the value of the improved readiness of the US military once vaccines are mandatory? And how do you compare that to the potential for long term side effects from vaccines using brand new technology?
It seems like there are so many levers to pull on this that anyone could just get the answer they want.
I think you have this wrong. I would think you have enough experience as a writer to understand how you are haunted by real or perceived bad takes. Well that works for everyone and in every business. And that is the way it works for the FDA too. And the CDC and the WHO as well. Accrued bad takes and mistakes are NEVER forgotten. Which is why the decision making processes for drug approvals are inherently conservative. And the FDA by the way is a much admired and copied institution around the world. They do, of course, have a process for dealing with exceptions and that is EUAs. And so they should.
It is probably a good thing to remember that many drugs with good efficacy (say statins) wind up getting withdrawn from the market and result in monster class action suits even though clinical trials did not reveal and could not statistically reveal lethal side effects. These often do not become evident until millions of prescriptions have been written. I seriously doubt that the long term confidence in the FDA is going to be enhanced by loosening standards and creating more fuckups. The lawyers will love it though.
My trust in the FDA has been irrecoverably shattered by their terrible, way-too-conservative handling of this pandemic. I’ll never forget their disastrous mistakes that have killed so many people and continue to kill many more.
Maybe take people like me into account when you’re weighing how to maintain public trust. There’s no reason to believe the public prefers doing nothing to doing something.
I will never forget that when Pfizer announced on Friday, November 20th, 2020 that they had just submitted their application for their vaccine EUA, the FDA issued a press release later that day saying,
“The week of Nov. 23, the FDA intends to issue a Federal Register notice with details of the meeting, which will include information about a public docket for comments. At that time, public comments can be submitted.”
Then they went home for the weekend. And they took Thanksgiving off. And the next weekend. This when there were around 1,200 people in the US dying from COVID every day.
Colleague-of-colleage of mine was a drug reviewer for the FDA who died by suicide this past year, it’s said because of the intense work pressure during COVID.
My thinking about it is twofold: no such pressure seemed to have actually shown up on the timeline for vaccine and treatment approvals, and more frankly, at a rate of one death every two minutes from COVID, there being only one work-pressure-related suicide among approval panelists indicates we weren’t pressuring panelists anywhere close to hard enough.
Good for you. It gets shattered a lot more when approved drugs turn out to have lethal or even damaging side effects rare though they be and get withdrawn from the market. If you consider making vaccines available to everyone who wants them a mistake I will enjoy hearing why.
Is there actual evidence that the current level of risk-aversion is optimal for public trust? It’s plausible, but it seems clear to me that the real reason for current procedure is doctors are super risk-averse and imposing their preferences on the rest of us and then backfilling justifications later.
Some mistakes from the FDA (and other public health folks):
Not allowing others to come up with a covid test and then botching their own test
Not considering challenge trials to approve vaccines faster (the worst mistake)
Never approving AstraZeneca even though Britain did (even though we had a domestic supply and vaccine shortages for months)
Not giving vaccines full approval
Slow approvals for kids (it’s been many months since the vaccines were approved for adults; why so long?)
Lying about face masks
Never studying different vaccine dosages (the biggest problem remaining today)
Not considering delaying second vaccine doses
Not telling people who got one dose of J&J to get another dose. Not studying this.
There's a great formal treatment of this question from a 2019 Journal of Econometrics paper: https://alo.mit.edu/wp-content/uploads/2015/08/Is-the-FDA-Too-Conservative-or-Too-Aggressive-A-Bayesian-Decision-Analysis-of-Clinical-Trial-Design-UPDATED.pdf
Early on in the vaccine rollout, there was a debate over whether or not we should split up the vaccine shots by a little bit more to double the number of people who were vaccinated. This ended up not materializing, because by the time the public had any kind of opinion on it the supply issue had already more or less been resolved, making this unnecessary.
With that said, I can't help but think an opportunity was probably missed there. All the early studies I saw suggested that getting only one shot of the vaccine confers about 85% of the immunity acquired with two shots; instead of being 95% effective, just one shot of the Pfizer vaccine would be 80% effective. While a considerable drop, this still put it significantly ahead of the J&J vaccine on your first shot. I am inclined to think we could have doubled the rate of the early rollout, but because of the issue you discussed at the end we opted not to.
The likely reason the CDC decided against this option was because there was no solid public opinion on it, and it would have probably bothered those who had already scheduled their second shot appointments. But that's bad grounds for making public policy. They should have done what would end the pandemic the fastest, and that would have been splitting up shots and doubling the speed of the early rollout.
The political climate in which we exist has created an atmosphere where public officials in government agencies are afraid of the political repercussions of acting and while the most obvious example of this is with the CDC, I can't help but think this likely plagues the top levels of all government offices, whether that be the FTC, DOJ, ATF, and so forth.
Does anyone trust the FDA more NOW than they did in 2019? I think the "public confidence" argument is hollow to begin with.
So are you saying the reason the FDA might be a month slower in giving full approval to Pfizer is because Pfizer isn’t lobbying them hard enough? Did you actually answer why the process is slow, or did I miss it?
I may have missed this, but is there a reason not every post is available on Curio?
Cost benefit and risk analysis are two big victims of this pandemic, and probably modern society as a whole.
When 1 in a million hits the headlines (whatever the subject), people go bonkers.
Half the country thinks they are dire danger from Covid. Half the people think they are at zero risk.
It explains why people think crime is going up (well it is now.... but it wasn't for the longest time).
Or why people go nuts over AR-15s despite the real danger being glocks.
The only modern exception I can think of is professional sports. They have moneyball down.
I honestly don't know what the FDA approval process means during a time of a raging pandemic. The EUAs have led to 340 million shots administered, and counting. Given that, could you imagine the FDA deciding to pull the EUAs and tell everyone that getting the shot is a bad idea and potentially dangerous? And while "everyone" knows already that the vaccine is safe and should be approved today (heck, that's how I feel), someone has to be in charge of looking at the data in a systematic, objective, scientific way; that's why we have the FDA rather than counting up Twitter votes.
Except that, with 340 million shots in people's arms, it's really too late for a systematic, objective, scientific examination of its safety and effectiveness; the die has been cast. So, just go ahead and approve the damn thing. Like the Fed in March 2020, if everything turns out fine, no one will be complaining about the FDA's shortcircuiting of the process and not behaving in the most objective, rule-bound way.
I just want to point out that the requirements for data indicating safety and efficacy aren’t less stringent for EUA than for a traditional NDA, so the FDA actually already has the data they need to approve.
What makes the EUA different from the NDA is just that you can start manufacturing while the EUA application is in review, and EUA applications jump to the head of the review queue. That’s it; the “process” here for full NDA approval of the vaccines is just that now they don’t jump the queue ahead of boner pills and statins.
I thought that the EUA required 2 months of data while the full approval required 6 months of data, is that wrong?
https://www.wkyc.com/article/news/health/coronavirus/vaccine/difference-between-emergency-use-authorization-and-full-fda-approval-coronavirus-vaccines/95-f2a7a6ba-eeee-4352-b3c7-8dce70cfba67
This is a pretty minor nit, but it still bugged me. Regarding Canada's one-shot strategy, MY writes: "But then you can see how first shots first worked by looking at how they caught up to and then surpassed us."
That's not why Canada is passing us by. It's because we ran out of people who wanted to get vaccinated. We hit a peak of 3.7 million shots/day in mid-April; we're under 600,000/day now. If we were populated by Canadians, we'd have a lot more vaccinated people now.
FDA-er here. The critique here is absolutely spot-on - I'm gob-smacked by how Matt has lined up the relative issues and weighed the subtleties (with one exception, mentioned below). What to do about it is much less well-developed. FDA is an enormous ocean liner; it can't change on a dime. Changes like these take years and are likely to produce all sorts of unintended consequences.
The point that is missing from Matt's analysis is that once a product is approved, it can in most cases be legally used in any way a medical practitioner sees fit. If Medicare or other insurers want a cost-benefit analysis to pay for a given use (particularly if that use is not FDA-approved), they can do it themselves. If it is useful from a public good standpoint for some disinterested party to do that analysis, the best model is to create an agency designed for that purpose like NICE in the
UK.
More importantly, the prospect of a NICE-type agency is anathema to the health care industry. Congress has regularly kneecapped AHRQ, the agency we have that is closest to NICE, whenever it began to take this subject seriously. There is less chance of FDA, Medicare, AHRQ or some other agency creating a sound cost-benefit framework than there is of CDC studying gun violence as a public health problem.
How much do you think that the FDA's decisions on breadth or narrowness of a drug's indication impacts all this? Obviously off-label use is rampant, but narrower indications do help commercial payors limit coverage.
The decision on breadth or narrowness depends on the studies used for approval. The drug company takes a calculated risk: if they test too broad a range of patients it may drown out evidence of benefit in a subgroup and you can't pick out a subgroup post hoc and say, "hey it worked for them" (you would have to do an additional study where that group is identified prospectively). If they test a narrow group, they get the indication for just that group and are not allowed to market it more broadly. Although there may be a whispering campaign encouraging broader use, they can get in big trouble if they are found to be behind it and the commercial payers do push back against this.
Whether a drug provides enough benefit to merit approval and its pricing are related but separate questions. FDA approval gives license for companies to set prices based on the FDA approval -> CMS coverage -> payor coverage and payment equation, as MY states. I don't think that FDA consideration of pricing would improve their decision-making; better would be to allow Medicare to play a negotiating role. Also, it's not a pure free-for-all. Commercial insurers choose what formulary status to give a drug. Whether a drug is covered as first-, second-, or third-line therapy by insurers has a massive impact on sales. Drug companies will generally reduce prices if they fear being assigned second- or third-line formulary status. While the resource-allocation mentality of international regulators probably does lead to different drug evaluations, it doesn't suggest making the FDA think about economic cost-benefit analysis. The UK cost benefit work is done by NHS when it decides what to cover and what to pay. That is totally distinct from the drug approval, which has been done by the European Medicines Agency (but will change to the UK post-brexit).
There are good questions as to whether the FDA could be better at weighing the medical cost-benefit of each drug it evaluates. The agency weighs these differently across different disease states and therapeutic classes. Partly this is because it relies on experts in each field (oncology, infectious disease, etc.) who bring their own biases. But patient groups, institutional bias, play a role. Some are criticizing the FDA for being risk adverse to prior failures, but is that really unfair? Wouldn't we want them to tighten standards when they find that previous standards led to ill effects?
What I most wish for is a bit better judgement from FDA. They are strict about trial protocols because there is a long history of drug companies post-hoc digging for statistically-significant findings to support claims (p-hacking their way to coverage). The FDA is right to guard against this. But then they apply this to the AZ vaccine trial, where the issue is completely different. Ultimately we have to trust regulators to exercise good judgment.
"There is a very strong presumption among public sector entities that you cannot mandate a vaccine based on an EUA."
On what is that very strong presumption based? Does it come from the FDA itself? Why is the problem not with the presumption (or whatever it is the presumption based on)?
I can only speak for military members but in that case it’s illegal. The historical reasons for this are due to the government literally experimenting on military personnel. So the FDA either needs to approve the vaccines or Congress needs to change the law.
You'd think that in an *emergency* you should be able to mandate a drug authorized for *emergency use*.
A few weeks after saying that the CDC shouldn't be doing cost benefit analysis and just putting out the science, you're arguing that the FDA should. This is wrong.
The FDA should be approving drugs. For an amazing vaccine, perhaps accelerated full approval makes sense, but unfortunately we have a frequentist rather than a bayesian org. (Your/Rosenthal's critiques of the FDA approving marginally useful expensive drugs is on point, but not useful for the EUA argument).
The CDC is literally there for *Control*. It should be responsible for doing what is required for controlling epidemics.
Critically, I think, this is the question. What if we had only Sinopharm or some other much more crappy much more side effect ridden vaccine? In a pandemic would *still* want to require everyone to take it. The value to the country as a whole is worth much more than the individual side effects. Once the pandemic is under control, you wouldn't want the vaccine to be used though.
To do this, in the "FDA cost effectiveness model" you'd want the FDA to approve it, and then disapprove it. This makes zero sense. The FDA doesn't even have people thinking about epidemics. The CDC, on the other hand, does have a lot of people thinking about epidemics, and should be capable of requiring a vaccine for the greater good in an emergency.
The problem is the politics - as soon as you're past the emergency, once there is no pandemic, especially if you start vaccinating early and the pandemic doesn't happen (as would be ideal) then the people who did have the side effects from the crappy vaccine start feeling quite grumpy about the whole thing.
And that's why we can't deal with an emergency. The problem is us.
The FDA definitely has people thinking about epidemics! I work with a ton of them; indeed, I’m one of them.
Learn something new! Thank you, I stand corrected. Based on what (Wikipedia says) the FDA does vs. the CDC I'm not sure I understand why. I mean, sure, to issue an EUA you have to know you have an E but surely other orgs know this? Is this just the FDA taking over part of the CDC's job?
One reason is that the FDA is more “muscular” than the CDC - I work in food, so if there’s an outbreak of Listeria in (say) ice cream, all the CDC can do is recommend that retailers pull the ice cream off the shelves and that consumers check their lot numbers and throw it away.
The FDA can actually force a manufacturer recall, force a contaminated plant to cease operations, seize and destroy affected foods, and even pursue prosecutions of company executives who acted with disregard for food safety practices to the public’s detriment. Much of that authority stems from the E coli poisonings in hamburgers (Jack in the Box) from the 90’s. I actually knew a guy whose girlfriend was in a coma for a while due to a hamburger-related E coli infection.
And of course since it’s inception the FDA has had the power to interdict the sale of food and drug products that were dangerous to public health. The FDA is a regulator; the CDC’s role is primarily in study, surveillance, and public health control of diseases. But the CDC either needs your permission or a court order to come onto your property and treat a mosquito swamp; the FDA can do it on its own authority provided you’re a facility the FDA regulates.
When did he say CDC shouldn't do cost/benefit analysis?
"Biden's CDC has done the right thing — they say true things about public health."
You're right, it's a little hard to tell exactly what Matt thinks the CDC should be doing here, but it looks like model based recommendations isn't it.
I thought Matt supported the CDC reporting out facts as they know them and letting elected officials and the populace decide on how to change/not change their behaviors based on those facts. For example, I thought Matt believed that the CDC should have been upfront about the benefits of masking right away and not have engaged in a cost-benefit like analysis in opting not to recommend mask wearing to preserve PPE for frontline medical personnel.
Cost-benefit analysis sounds great until you disagree with the decision makers' weighing of the costs and benefits.
He did say that the CDC does not do cost-benefit. (https://www.slowboring.com/p/cdc-normal)
Given the context in which he said it, he didn't seem to think the CDC not doing cost-benefit was a bad thing. Rather, he suggested it is something people should be aware of and act accordingly with respect to CDC guidance.
Clearly he feels very differently about the FDA.
“I didn't have time to write a short letter, so I wrote a long one instead.”
Mark Twain
I look forward to better guidance from the FDA about timing of vaccine availability for children under 12.
It seems like a cost benefit analysis would get very complicated and political very quickly. Should the FDA account for the lifetime economic value of second graders getting one year of in-person learning? We have no basis for measuring that. Should they estimate the value of the improved readiness of the US military once vaccines are mandatory? And how do you compare that to the potential for long term side effects from vaccines using brand new technology?
It seems like there are so many levers to pull on this that anyone could just get the answer they want.
Approving drugs is already very complicated.
I think you have this wrong. I would think you have enough experience as a writer to understand how you are haunted by real or perceived bad takes. Well that works for everyone and in every business. And that is the way it works for the FDA too. And the CDC and the WHO as well. Accrued bad takes and mistakes are NEVER forgotten. Which is why the decision making processes for drug approvals are inherently conservative. And the FDA by the way is a much admired and copied institution around the world. They do, of course, have a process for dealing with exceptions and that is EUAs. And so they should.
It is probably a good thing to remember that many drugs with good efficacy (say statins) wind up getting withdrawn from the market and result in monster class action suits even though clinical trials did not reveal and could not statistically reveal lethal side effects. These often do not become evident until millions of prescriptions have been written. I seriously doubt that the long term confidence in the FDA is going to be enhanced by loosening standards and creating more fuckups. The lawyers will love it though.
My trust in the FDA has been irrecoverably shattered by their terrible, way-too-conservative handling of this pandemic. I’ll never forget their disastrous mistakes that have killed so many people and continue to kill many more.
Maybe take people like me into account when you’re weighing how to maintain public trust. There’s no reason to believe the public prefers doing nothing to doing something.
I will never forget that when Pfizer announced on Friday, November 20th, 2020 that they had just submitted their application for their vaccine EUA, the FDA issued a press release later that day saying,
“The week of Nov. 23, the FDA intends to issue a Federal Register notice with details of the meeting, which will include information about a public docket for comments. At that time, public comments can be submitted.”
Then they went home for the weekend. And they took Thanksgiving off. And the next weekend. This when there were around 1,200 people in the US dying from COVID every day.
Colleague-of-colleage of mine was a drug reviewer for the FDA who died by suicide this past year, it’s said because of the intense work pressure during COVID.
My thinking about it is twofold: no such pressure seemed to have actually shown up on the timeline for vaccine and treatment approvals, and more frankly, at a rate of one death every two minutes from COVID, there being only one work-pressure-related suicide among approval panelists indicates we weren’t pressuring panelists anywhere close to hard enough.
Two thoughts:
1. If you think that a suicide has a simple and obvious explanation, you are likely wrong.
2. The FDA has shown themselves to be culturally incapable of responding to an emergency. They should never be allowed to try to do so again.
Good for you. It gets shattered a lot more when approved drugs turn out to have lethal or even damaging side effects rare though they be and get withdrawn from the market. If you consider making vaccines available to everyone who wants them a mistake I will enjoy hearing why.
Is there actual evidence that the current level of risk-aversion is optimal for public trust? It’s plausible, but it seems clear to me that the real reason for current procedure is doctors are super risk-averse and imposing their preferences on the rest of us and then backfilling justifications later.
Some mistakes from the FDA (and other public health folks):
Not allowing others to come up with a covid test and then botching their own test
Not considering challenge trials to approve vaccines faster (the worst mistake)
Never approving AstraZeneca even though Britain did (even though we had a domestic supply and vaccine shortages for months)
Not giving vaccines full approval
Slow approvals for kids (it’s been many months since the vaccines were approved for adults; why so long?)
Lying about face masks
Never studying different vaccine dosages (the biggest problem remaining today)
Not considering delaying second vaccine doses
Not telling people who got one dose of J&J to get another dose. Not studying this.