Vaccines could have been approved in Spring if 2020 if we had challenge trials. Not conducting challenge trials was the single greatest institutional failure during the pandemic.
Two generations ago, our grandfathers stormed beaches, flew combat missions into heavy anti-aircraft fire and steamed across oceans teeming with Uboats to defend our country. Many were conscripted. In 2020, our government would not let healthy young volunteers take a 1 in 2000 chance of death to save tens or hundreds of thousands of people. The risk would be even lower if the vaccines worked!
Our pandemic response stank of cowardice. Early in the pandemic the courts were closed and I didn’t have much to do. I’m not the type to shelter in place, I wanted to help my country. I would have taken a job processing unemployment claims or tracing contacts or volunteered for a challenge trial. There should have been legislation to help people take “pandemic jobs” and then transition back to their regular jobs after the pandemic. I wanted to engage in useful activity, I was willing to take physical risks, and I certainly didn’t want to cower at home and watch people freak out on cable TV. I volunteered for clinical trials and wrote the Russian ambassador asking to participate in the trial of the Sputnik vaccine. Nothing came of my efforts, and I ended up dissipating my energy hiking in the few national forests that weren’t closed. The PPP paid me $20,800 to sit on my ass, so at least my balance sheet didn’t crumble.
There’s a New Yorker cartoon that pops up a lot when economic policy is being discussed: it’s a bunch of disheveled people sitting around a campfire, clearly in some sort of post-apocalyptic scenario, and the person speaking is captioned “but at least for one brief moment we created a lot of value for our shareholders.”
The COVID-era one would need to be re-captioned “but at least for one brief minute we got to fully and rigorously apply our research protocol guidelines and medical ethics training.”
I’m old enough to have cut my teeth, activism-wise, in ACT UP, which had made the entirely correct observation that the FDA was moving at a speed determined by their institutional incentives rather than the actual needs of people dying of a horrific disease. Silly us: in retrospect our one big (if understandable) error was the assumption that things would work any differently if the people dying were “normal”.
For me, the CDC and FDA have proven themselves to be unreliable and untrustworthy at even the most basic public health tasks. Frankly, imo they're a national disgrace.
It's mostly about cloth masks and doesn't even touch on the effectiveness of cloth masks versus surgical, KN95, and N95 masks. AS OF TODAY, THE SITE STILL WARNS PEOPLE NOT TO USE N95 MASKS because they're needed for healthcare workers.
Counter this with Germany, where they mandate medical grade masks and where each household gets free high quality masks provided by the government:
I wonder whether part of the institutional inflexibility is because the public health apparatus is grounded in the scientific process. This isn’t necessarily bad, per se. Of course not! But speaking as a scientist — as a community we collectively learned from experience to never EVER rush, or when we do, to be excruciatingly careful. It’s scientifically risky to rush. You might miss making a key observation. This is basically part of our training. Letting a lengthy scientific process unfold, slowly, collecting tons of data, and refusing to rush, is often what allows the exceptions, the misinterpretations, and the unanticipated/infrequent results to reveal themselves. It’s called the scientific process for a reason; the process is what makes the effort scientific.
So in fighting this institutional inflexibility — an objective I agree with! — it’s probably worth keeping in mind that scientists as a group often don’t want to be rushed, bc rushed science is frequently bad science that can lead us astray, or in the worst cases, hurt people or communities. In my view, there’s a natural conservatism here, inherent to the scientific process, that might be challenging to shift.
This article highlights my daily frustration for the past month or so. There have been several times during this pandemic where the messaging from CDC/public health has sometimes been spin/manipulation of truth, and sometimes rules that are so rigid that they are in direct conflict to what I think is best for my patients. A perfect example was the J&J vaccine, which was clearly not as good as the mRNA ones, but when there was a shortage of vaccines, we needed everyone to get vaccinated with whatever was available. I didn't lie to my patients and tell them it was the same. I said they could always get one of the mRNA vaccines in several months when availability was better. I didn't know this wasn't going to be allowed and someone would have to lie and say they weren't yet vaccinated if they wanted one of the other vaccines.
And even now, immunocompromised people can get a booster with one of the mRNA vaccines, but not the J&J. I have a patient who got J&J about 6 months ago, is now getting chemo for breast cancer and she is not eligible for a booster. I would like her to either get another J&J or complete one of the mRNA series, but she'll have to lie at the pharmacy to do that. A 47 yr-old diabetic patient (mildly overweight) just passed away from a breakthrough Covid infection. His J&J shot was in February. Ok, I know - 1 data point. But this anxiety-producing. I feel hamstrung by rigid rules and regulations that countermand what I think is best for my patients.
There are always situations like that in medicine: recommendations that apply to the population at large, but that may not apply to the individual or off-label recommendations that you make as a doctor given the best data available to you. But for the first time on a large scale, I'm faced with recommendations I would like to make but cannot b/c of inflexible rules.
I've always enjoyed this example from Tetlock's book... but it seems the lesson has been overlearned.
"They didn’t need scientific validation. They just knew. Cochrane despised this attitude. He called it “the God complex.”
When hospitals created cardiac care units to treat patients recovering from heart attacks, Cochrane proposed a randomized trial to determine whether the new units delivered better results than the old treatment, which was to send the patient home for monitoring and bed rest. Physicians balked. It was obvious the cardiac care units were superior, they said, and denying patients the best care would be unethical. But Cochrane was not a man to back down. As a prison camp physician treating fellow POWs during World War II he often stood up to the authorities. On occasion, he loudly berated trigger-happy German guards. So Cochrane got his trial: some patients, randomly selected, were sent to the cardiac care units while others were sent home for monitoring and bed rest. Partway through the trial, Cochrane met with a group of the cardiologists who had tried to stop his experiment. He told them that he had preliminary results. The difference in outcomes between the two treatments was not statistically significant, he emphasized, but it appeared that patients might do slightly better in the cardiac care units. “They were vociferous in their abuse: ‘Archie,’ they said, ‘we always thought you were unethical. You must stop the trial at once.’ ” But then Cochrane revealed he had played a little trick. He had reversed the results: home care had done slightly better than the cardiac units. “There was dead silence and I felt rather sick because they were, after all, my medical colleagues.”
This is a point I made in another discussion here, but I think it deserves repeating:
Pfizer submitted its application for Emergency Use Authorization for their vaccine to the FDA the morning of Friday, November 20, 2020. This was not at all a surprise as they had issued many earlier press releases detailing the results of their clinical trials, including one some two weeks earlier announcing that they were beginning the process of submitting the application. The FDA was aware of all this. Presumably they were also aware of how many people were dying every day, though I may be giving them too much credit.
The afternoon of Friday, November 20, 2020, the FDA issued their own press release noting Pfizer's request and announcing that an advisory committee would meet THREE WEEKS LATER on December 10th. That notice said, in part,
"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. These comments will be reviewed by the FDA."
Then they took the weekend off. And Thanksgiving and the following weekend.
This is not merely an example of sclerotic and bureaucratic behavior; it is shameful.
The FDA is very much not your friend, and does not deserve your respect. The FDA does not deserve to exist.
You want the FDA to approve the vaccines with a different, faster process. BUT, THAT'S EXACTLY WHAT THEY DID! When they use a different process, they use a different term for it - Emergency Use Authorization. If they approved more quickly with a different process and then claimed that they had done the full process, that would be a lie. So, it's not surprising there's a different term for it.
Maybe we should have used a different term, like Rapid Approval, or something. But, the fact is they did exactly what you're calling for.
Matt has an extremely common, and somewhat bonkers opinion. The FDA is doing precisely what it is supposed to be doing here.
Since April there have been about 200 covid deaths per million in the US. So, if you chose to be unvaccinated for the last five months, then that was roughly your increased chance of death from covid.
The vaccines also have a risk. There have been roughly 35 deaths per million of people who have had the vaccine in that time frame according to VAERS, but the vast majority of those deaths were almost certainly from another source. A covid shot is not going to protect you from an unrelated heart attack.
There has been a total of 3 deaths due to thrombosis with thrombocytopenia syndrome … about 0.02 per million… that are directly attributable to the J&J vaccine. As far as we know, those are the only deaths. But it is not impossible that there are more.
So _on average_, we now know that it is vastly safer to take the vaccine then to be unprotected. The FDA had enough evidence to determine this with Moderna last December, which is why it authorized it for emergency use. And they turned out to be right! The EUA vaccines are vastly safer than not being vaccinated.
But we don’t actually know that the vaccines are safe and effective for all sub-populations. The J&J vaccine, for example, has a higher risk for younger women. The FDA, correctly, decided to briefly halt administration of the J&J vaccine until it could figure out if it was safe for this subpopulation.
Determining that a vaccine is safe and effective on average is extremely difficult. Determining that it is safe and effective for all subpopulations is even more difficult. That’s what the FDA has to figure out before it can give full approval.
Yes, In all likelihood the FDA is going to grind through their data and the bureaucracy will eventually determine that Moderna et al as safe. And then Matthew Yglesias, Tyler Cowen, and everyone on this comment section will crow about being right.
But if the FDA did bow to pressure to become “more flexible”, and they approved the vaccines before being certain, and it turned out that a vaccine caused harm to left-handed Scotsmen (for example), then I doubt any of you would lose too much sleep.
But the FDA would take a massive hit, and the left-handed Scottish antivaxxers would scream vindication, and everyone who received mandatory vaccinations would sue. And then what happens in the next pandemic, when the FDA has already shown it can’t be trusted?
It’s one thing to argue that, as a political question, we should encourage everyone to be vaccinated. But we can’t base our politics on fact, and then use politics to influence the facts.
To me the craziest thing is that, while delaying full approval of the vaccines that have been given to millions under the EUA, the FDA went ahead and gave full approval to an Alzheimers drug that did not demonstrate effectiveness in clinical trials, against the advice of every member of their advisory panel for that drug. And yet they had the nerve to talk about “undermining confidence”…
Excellent post. Your point about adherence to protocol as a crutch is well put.The bureaucracy and adherence to protocol can be stifling in healthcare. I should know because Im a nurse who dealt with the worst of the pandemic. I remember that when the pandemic began in March of last year my immediate superior was fretting what to do about covid cause the cdc didn't release any guidelines. I was thinking to just approach the situation like you do with any unknown disease: gown up with an n95 and face shield. Which us what ended up becoming hospital protocol(we are a very well off hospital so we had all the ppe we could want). It shouldn't be difficult to follow best practices without cdc guidance.
But that incident pails in comparison to another healthcare issue: "HIPPA (sic) Violations." The cult of HIPAA is strong in healthcare and is a prime example of willful bureaucratic paralysis in the industry. It is used to prevent collaboration between colleagues all the time. Why sometimes other nurses get angry with me when I check their patients EHR cause I am "violating HIPAA." I'm sorry but this patient you haven't seen in hours has an abnormally high blood pressure and needs it lowered now. Let me look at his chart so I know which meds to give him.
Not saying that HIPAA is unimportant or that patient confidentiality isn't important. Just that it is common in healthcare for HIPAA to be used as a crutch for inaction.
There is other regulatory BS which gets on my nerves. Like how smartwatches can't be used to monitor patient heartrates at my hospital in spite of them performing better than our current monitors. There are just too many headaches in the field with regulations.
>>>Relatedly, they continue to not recommend that people who got the Johnson & Johnson shot get an mRNA booster even though there is clear data to support that idea. The issue, as Leana Wen of the Milken Institute School of Public Health explains, is that nobody has done a specific safety trial on the mix-and-match<<<
My sense after reading this article is that quite a few of the examples cited by Matt (I've excerpted one, above) aren't issues of lack of flexibility so much as lack of state capacity. Given the gravity of the crisis that confronted the country in the winter of 2020, we should have marshaled much greater resources toward fighting the pandemic. More studies, more "trying everything," more use of available technologies (like smartphone-based contact tracing software), more use of the Defense Production Act. In short, a titanic national effort. And yes, greater capacity would have enabled greater flexibility.
Also, in the realm of public health, I can't help but suspect the country's lack of genuinely universal, government-guaranteed healthcare coverage also plays a role.
American governance as a whole — not just its public health apparatus — isn't operating at a very high level by rich country standards, from what I can tell. I believe the US is suffering a genuine crisis of governance.
I'm reminded of Vandiver Bush's writing about how the organizational structures required to execute a plan at scale are very different from the structures required to creatively come up with new ideas. In normal times a certain amount of inflexibility/process is a good thing to have in our public health system. But it would be nice to have some means of overriding business as normal in emergencies.
To defend the FDA, the EUA is flexibility at work: It allowed the manufacturers to distribute the vaccine. There was a recommendation on how to vaccinate based upon the clinical trials, but the FDA has no authority over how health care personnel practice. Health care personnel can make whatever decision they see fit subject to licensure boards, malpractice suits, damage to reputation, etc. Any bright ideas about vaccination that aren't covered by the clinical trials falls under the CDC; that's why they have their own vaccine advisory committee: they can suggest mix and match, boosters, etc.
The difference between the EUA and full approval is that approval is permanent: it's a license, effectively a contract between the manufacturer and FDA that makes the manufacturer accountable for thousands of details regarding manufacturing, safety monitoring and follow-up studies. As an analogy, say you need somewhere to live. the EUA is equivalent to certifying that a house is fit for habitation. Approval is the equivalent of a purchasing contract with all the details surrounding inspections, contingencies, escrow, etc.
I'm sympathetic to your complaint, but I would like to see your positive proposal.
What does flexibility look like in this context?
You write,
"the reason the Moderna vaccine should have full authorization is that nobody in any position of power or authority in the United States is expressing any doubt about the wisdom of taking the Moderna vaccine."
But that is clearly not a policy that can be put into operation. It's also not literally true: there are people in positions of power and authority, e.g. Congressmen, who are anti-vax. Do you want a majority in Congress to decide on pharmaceutical safety and efficacy? A super-majority? A 5-4 SCOTUS ruling? That's obviously the wrong road to go down (as your mention of Trump makes clear).
Instead, I assume you have in mind a principle like this:
As the stakes go up, we should be willing to tolerate greater uncertainty in the approval process.
Currently, the FDA requires Phase III trials enrolling X number of people, showing effect sizes of Y magnitude, with confidence intervals smaller than E.
On your proposal, I take it, we'd have a rule like the following:
when faced with a medical catastrophe that threatens 0.1 million Americans, we reduce X and Y by 10%, and increase E by 10%. If it threatens 0.5 million Americans, then we reduce X and Y by 30%, and increase E by 30%.
That's not great, but it's at least something that can be implemented.
Vaccines could have been approved in Spring if 2020 if we had challenge trials. Not conducting challenge trials was the single greatest institutional failure during the pandemic.
Two generations ago, our grandfathers stormed beaches, flew combat missions into heavy anti-aircraft fire and steamed across oceans teeming with Uboats to defend our country. Many were conscripted. In 2020, our government would not let healthy young volunteers take a 1 in 2000 chance of death to save tens or hundreds of thousands of people. The risk would be even lower if the vaccines worked!
Our pandemic response stank of cowardice. Early in the pandemic the courts were closed and I didn’t have much to do. I’m not the type to shelter in place, I wanted to help my country. I would have taken a job processing unemployment claims or tracing contacts or volunteered for a challenge trial. There should have been legislation to help people take “pandemic jobs” and then transition back to their regular jobs after the pandemic. I wanted to engage in useful activity, I was willing to take physical risks, and I certainly didn’t want to cower at home and watch people freak out on cable TV. I volunteered for clinical trials and wrote the Russian ambassador asking to participate in the trial of the Sputnik vaccine. Nothing came of my efforts, and I ended up dissipating my energy hiking in the few national forests that weren’t closed. The PPP paid me $20,800 to sit on my ass, so at least my balance sheet didn’t crumble.
There’s a New Yorker cartoon that pops up a lot when economic policy is being discussed: it’s a bunch of disheveled people sitting around a campfire, clearly in some sort of post-apocalyptic scenario, and the person speaking is captioned “but at least for one brief moment we created a lot of value for our shareholders.”
The COVID-era one would need to be re-captioned “but at least for one brief minute we got to fully and rigorously apply our research protocol guidelines and medical ethics training.”
I’m old enough to have cut my teeth, activism-wise, in ACT UP, which had made the entirely correct observation that the FDA was moving at a speed determined by their institutional incentives rather than the actual needs of people dying of a horrific disease. Silly us: in retrospect our one big (if understandable) error was the assumption that things would work any differently if the people dying were “normal”.
For me, the CDC and FDA have proven themselves to be unreliable and untrustworthy at even the most basic public health tasks. Frankly, imo they're a national disgrace.
Take a look at the CDC's CURRENT mask guidance
https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/about-face-coverings.html
It's mostly about cloth masks and doesn't even touch on the effectiveness of cloth masks versus surgical, KN95, and N95 masks. AS OF TODAY, THE SITE STILL WARNS PEOPLE NOT TO USE N95 MASKS because they're needed for healthcare workers.
Counter this with Germany, where they mandate medical grade masks and where each household gets free high quality masks provided by the government:
https://www.forbes.com/sites/tommybeer/2021/01/20/germany-mandates-medical-grade-masks/?sh=69ca21de2596
https://www.deutschland.de/en/videos/free-ffp-2-masks-for-27-million-german-citizens
An institution that can't get even this most basic public health guidance right is not fit for purpose. Period. Full stop.
I wonder whether part of the institutional inflexibility is because the public health apparatus is grounded in the scientific process. This isn’t necessarily bad, per se. Of course not! But speaking as a scientist — as a community we collectively learned from experience to never EVER rush, or when we do, to be excruciatingly careful. It’s scientifically risky to rush. You might miss making a key observation. This is basically part of our training. Letting a lengthy scientific process unfold, slowly, collecting tons of data, and refusing to rush, is often what allows the exceptions, the misinterpretations, and the unanticipated/infrequent results to reveal themselves. It’s called the scientific process for a reason; the process is what makes the effort scientific.
So in fighting this institutional inflexibility — an objective I agree with! — it’s probably worth keeping in mind that scientists as a group often don’t want to be rushed, bc rushed science is frequently bad science that can lead us astray, or in the worst cases, hurt people or communities. In my view, there’s a natural conservatism here, inherent to the scientific process, that might be challenging to shift.
This article highlights my daily frustration for the past month or so. There have been several times during this pandemic where the messaging from CDC/public health has sometimes been spin/manipulation of truth, and sometimes rules that are so rigid that they are in direct conflict to what I think is best for my patients. A perfect example was the J&J vaccine, which was clearly not as good as the mRNA ones, but when there was a shortage of vaccines, we needed everyone to get vaccinated with whatever was available. I didn't lie to my patients and tell them it was the same. I said they could always get one of the mRNA vaccines in several months when availability was better. I didn't know this wasn't going to be allowed and someone would have to lie and say they weren't yet vaccinated if they wanted one of the other vaccines.
And even now, immunocompromised people can get a booster with one of the mRNA vaccines, but not the J&J. I have a patient who got J&J about 6 months ago, is now getting chemo for breast cancer and she is not eligible for a booster. I would like her to either get another J&J or complete one of the mRNA series, but she'll have to lie at the pharmacy to do that. A 47 yr-old diabetic patient (mildly overweight) just passed away from a breakthrough Covid infection. His J&J shot was in February. Ok, I know - 1 data point. But this anxiety-producing. I feel hamstrung by rigid rules and regulations that countermand what I think is best for my patients.
There are always situations like that in medicine: recommendations that apply to the population at large, but that may not apply to the individual or off-label recommendations that you make as a doctor given the best data available to you. But for the first time on a large scale, I'm faced with recommendations I would like to make but cannot b/c of inflexible rules.
I've always enjoyed this example from Tetlock's book... but it seems the lesson has been overlearned.
"They didn’t need scientific validation. They just knew. Cochrane despised this attitude. He called it “the God complex.”
When hospitals created cardiac care units to treat patients recovering from heart attacks, Cochrane proposed a randomized trial to determine whether the new units delivered better results than the old treatment, which was to send the patient home for monitoring and bed rest. Physicians balked. It was obvious the cardiac care units were superior, they said, and denying patients the best care would be unethical. But Cochrane was not a man to back down. As a prison camp physician treating fellow POWs during World War II he often stood up to the authorities. On occasion, he loudly berated trigger-happy German guards. So Cochrane got his trial: some patients, randomly selected, were sent to the cardiac care units while others were sent home for monitoring and bed rest. Partway through the trial, Cochrane met with a group of the cardiologists who had tried to stop his experiment. He told them that he had preliminary results. The difference in outcomes between the two treatments was not statistically significant, he emphasized, but it appeared that patients might do slightly better in the cardiac care units. “They were vociferous in their abuse: ‘Archie,’ they said, ‘we always thought you were unethical. You must stop the trial at once.’ ” But then Cochrane revealed he had played a little trick. He had reversed the results: home care had done slightly better than the cardiac units. “There was dead silence and I felt rather sick because they were, after all, my medical colleagues.”
Tetlock, Philip E.; Gardner, Dan. Superforecasting (p. 31). Crown. Kindle Edition.
This is a point I made in another discussion here, but I think it deserves repeating:
Pfizer submitted its application for Emergency Use Authorization for their vaccine to the FDA the morning of Friday, November 20, 2020. This was not at all a surprise as they had issued many earlier press releases detailing the results of their clinical trials, including one some two weeks earlier announcing that they were beginning the process of submitting the application. The FDA was aware of all this. Presumably they were also aware of how many people were dying every day, though I may be giving them too much credit.
The afternoon of Friday, November 20, 2020, the FDA issued their own press release noting Pfizer's request and announcing that an advisory committee would meet THREE WEEKS LATER on December 10th. That notice said, in part,
"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. These comments will be reviewed by the FDA."
Then they took the weekend off. And Thanksgiving and the following weekend.
This is not merely an example of sclerotic and bureaucratic behavior; it is shameful.
The FDA is very much not your friend, and does not deserve your respect. The FDA does not deserve to exist.
You want the FDA to approve the vaccines with a different, faster process. BUT, THAT'S EXACTLY WHAT THEY DID! When they use a different process, they use a different term for it - Emergency Use Authorization. If they approved more quickly with a different process and then claimed that they had done the full process, that would be a lie. So, it's not surprising there's a different term for it.
Maybe we should have used a different term, like Rapid Approval, or something. But, the fact is they did exactly what you're calling for.
Matt has an extremely common, and somewhat bonkers opinion. The FDA is doing precisely what it is supposed to be doing here.
Since April there have been about 200 covid deaths per million in the US. So, if you chose to be unvaccinated for the last five months, then that was roughly your increased chance of death from covid.
The vaccines also have a risk. There have been roughly 35 deaths per million of people who have had the vaccine in that time frame according to VAERS, but the vast majority of those deaths were almost certainly from another source. A covid shot is not going to protect you from an unrelated heart attack.
There has been a total of 3 deaths due to thrombosis with thrombocytopenia syndrome … about 0.02 per million… that are directly attributable to the J&J vaccine. As far as we know, those are the only deaths. But it is not impossible that there are more.
So _on average_, we now know that it is vastly safer to take the vaccine then to be unprotected. The FDA had enough evidence to determine this with Moderna last December, which is why it authorized it for emergency use. And they turned out to be right! The EUA vaccines are vastly safer than not being vaccinated.
But we don’t actually know that the vaccines are safe and effective for all sub-populations. The J&J vaccine, for example, has a higher risk for younger women. The FDA, correctly, decided to briefly halt administration of the J&J vaccine until it could figure out if it was safe for this subpopulation.
Determining that a vaccine is safe and effective on average is extremely difficult. Determining that it is safe and effective for all subpopulations is even more difficult. That’s what the FDA has to figure out before it can give full approval.
Yes, In all likelihood the FDA is going to grind through their data and the bureaucracy will eventually determine that Moderna et al as safe. And then Matthew Yglesias, Tyler Cowen, and everyone on this comment section will crow about being right.
But if the FDA did bow to pressure to become “more flexible”, and they approved the vaccines before being certain, and it turned out that a vaccine caused harm to left-handed Scotsmen (for example), then I doubt any of you would lose too much sleep.
But the FDA would take a massive hit, and the left-handed Scottish antivaxxers would scream vindication, and everyone who received mandatory vaccinations would sue. And then what happens in the next pandemic, when the FDA has already shown it can’t be trusted?
It’s one thing to argue that, as a political question, we should encourage everyone to be vaccinated. But we can’t base our politics on fact, and then use politics to influence the facts.
Yes, the contrast between institutional inflexibility and the demands for social flexibility have been really striking. This inconsistency was a theme of the Op-ed Peter Singer & I wrote for the Washington Post back in April 2020: https://www.washingtonpost.com/opinions/2020/04/27/pandemic-ethics-case-experiments-human-volunteers/
For anyone blocked by the WaPo paywall, an open access expanded version of our argument is available as a short academic article here: https://journals.sagepub.com/doi/10.1177/1747016120931920
Much more in this vein is available on my blog, for anyone interested:
https://www.philosophyetc.net/2021/01/lessons-from-pandemic.html
To me the craziest thing is that, while delaying full approval of the vaccines that have been given to millions under the EUA, the FDA went ahead and gave full approval to an Alzheimers drug that did not demonstrate effectiveness in clinical trials, against the advice of every member of their advisory panel for that drug. And yet they had the nerve to talk about “undermining confidence”…
Excellent post. Your point about adherence to protocol as a crutch is well put.The bureaucracy and adherence to protocol can be stifling in healthcare. I should know because Im a nurse who dealt with the worst of the pandemic. I remember that when the pandemic began in March of last year my immediate superior was fretting what to do about covid cause the cdc didn't release any guidelines. I was thinking to just approach the situation like you do with any unknown disease: gown up with an n95 and face shield. Which us what ended up becoming hospital protocol(we are a very well off hospital so we had all the ppe we could want). It shouldn't be difficult to follow best practices without cdc guidance.
But that incident pails in comparison to another healthcare issue: "HIPPA (sic) Violations." The cult of HIPAA is strong in healthcare and is a prime example of willful bureaucratic paralysis in the industry. It is used to prevent collaboration between colleagues all the time. Why sometimes other nurses get angry with me when I check their patients EHR cause I am "violating HIPAA." I'm sorry but this patient you haven't seen in hours has an abnormally high blood pressure and needs it lowered now. Let me look at his chart so I know which meds to give him.
Not saying that HIPAA is unimportant or that patient confidentiality isn't important. Just that it is common in healthcare for HIPAA to be used as a crutch for inaction.
There is other regulatory BS which gets on my nerves. Like how smartwatches can't be used to monitor patient heartrates at my hospital in spite of them performing better than our current monitors. There are just too many headaches in the field with regulations.
>>>Relatedly, they continue to not recommend that people who got the Johnson & Johnson shot get an mRNA booster even though there is clear data to support that idea. The issue, as Leana Wen of the Milken Institute School of Public Health explains, is that nobody has done a specific safety trial on the mix-and-match<<<
My sense after reading this article is that quite a few of the examples cited by Matt (I've excerpted one, above) aren't issues of lack of flexibility so much as lack of state capacity. Given the gravity of the crisis that confronted the country in the winter of 2020, we should have marshaled much greater resources toward fighting the pandemic. More studies, more "trying everything," more use of available technologies (like smartphone-based contact tracing software), more use of the Defense Production Act. In short, a titanic national effort. And yes, greater capacity would have enabled greater flexibility.
Also, in the realm of public health, I can't help but suspect the country's lack of genuinely universal, government-guaranteed healthcare coverage also plays a role.
American governance as a whole — not just its public health apparatus — isn't operating at a very high level by rich country standards, from what I can tell. I believe the US is suffering a genuine crisis of governance.
I'm reminded of Vandiver Bush's writing about how the organizational structures required to execute a plan at scale are very different from the structures required to creatively come up with new ideas. In normal times a certain amount of inflexibility/process is a good thing to have in our public health system. But it would be nice to have some means of overriding business as normal in emergencies.
To defend the FDA, the EUA is flexibility at work: It allowed the manufacturers to distribute the vaccine. There was a recommendation on how to vaccinate based upon the clinical trials, but the FDA has no authority over how health care personnel practice. Health care personnel can make whatever decision they see fit subject to licensure boards, malpractice suits, damage to reputation, etc. Any bright ideas about vaccination that aren't covered by the clinical trials falls under the CDC; that's why they have their own vaccine advisory committee: they can suggest mix and match, boosters, etc.
The difference between the EUA and full approval is that approval is permanent: it's a license, effectively a contract between the manufacturer and FDA that makes the manufacturer accountable for thousands of details regarding manufacturing, safety monitoring and follow-up studies. As an analogy, say you need somewhere to live. the EUA is equivalent to certifying that a house is fit for habitation. Approval is the equivalent of a purchasing contract with all the details surrounding inspections, contingencies, escrow, etc.
I'm sympathetic to your complaint, but I would like to see your positive proposal.
What does flexibility look like in this context?
You write,
"the reason the Moderna vaccine should have full authorization is that nobody in any position of power or authority in the United States is expressing any doubt about the wisdom of taking the Moderna vaccine."
But that is clearly not a policy that can be put into operation. It's also not literally true: there are people in positions of power and authority, e.g. Congressmen, who are anti-vax. Do you want a majority in Congress to decide on pharmaceutical safety and efficacy? A super-majority? A 5-4 SCOTUS ruling? That's obviously the wrong road to go down (as your mention of Trump makes clear).
Instead, I assume you have in mind a principle like this:
As the stakes go up, we should be willing to tolerate greater uncertainty in the approval process.
Currently, the FDA requires Phase III trials enrolling X number of people, showing effect sizes of Y magnitude, with confidence intervals smaller than E.
On your proposal, I take it, we'd have a rule like the following:
when faced with a medical catastrophe that threatens 0.1 million Americans, we reduce X and Y by 10%, and increase E by 10%. If it threatens 0.5 million Americans, then we reduce X and Y by 30%, and increase E by 30%.
That's not great, but it's at least something that can be implemented.
So what's your positive proposal?