Fools and Knaves and the FDA

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There is something very important you need to know about the Pfizer vaccine.

It is NOT approved by the FDA. In, fact, none of the vaccines are. It has Emergency Use Authorization because it may be effective for the prevention of COVID-19. Significant existence or magnitude risks and benefits of the vaccine are unknown. Providers may not tell you this, though they are supposed to.

Sorry if I sound like Tucker Carlson here. These words aren’t really mine, for the most part. But they aren’t Carlson’s either. They’re not from Fox News or an anti-vaccine website. They’re from Pfizer’s own labeling and the FDA itself. Most of this is from the section labeled “Information to provide to vaccine recipients/caregivers”.

It is also, most people believe (including but not limited to those in the FDA and at Pfizer) incorrect. Or Twitter and Facebook fact-checkers, for that matter. The only debate most people are having is whether they are highly effective or incredibly effective and whether the risk is small or infinitesimal. We also know that while there are some risks, they are really quite rare. Dr Fauci says that approval is inevitable, and we should act like it’s already been approved.

Except, of course, it hasn’t been approved. It’s right there in the words the FDA requires Pfizer to tell providers to tell their patients. Words that could get you promoted at Fox, or punished by social media. The FDA’s position on this has slowed down vaccination mandates and prevented advertising. It’s prevented us from being able to say that it has been approved, forcing everybody to dance around and try to explain that on some level neither the approval matters nor all of the words that have to be said in the absence of that approval.

To be clear, I don’t know what effect this is having on vaccine uptake. It prevented mandates for a long while, but it looks like the wall on that is finally coming down as businesses and governments lose patience. It is cited by some of the vaccine-hesitant for the reason they are hesitant, but you never really know how much of that is genuine and isn’t. It has prevented advertising and public proclamations of complete approval (making arguments for safety and efficacy weaker than they otherwise might be), which may matter on some level or may not.

To also be clear: I frankly don’t much care. Well, that’s not entirely true. The more it is preventing people from getting vaccinated the more it matters to me. But even if it is having no effect at all on uptake, it is fundamentally a problem that we have a drug we more-or-less know is safe but have a barrier to our saying so and are giving people reason to lack confidence. It’s a credibility problem when believing or repeating the warnings of our highest regulatory agency makes you a fool or a knave.

If we know it is safe, it should be approved. If we don’t know it’s safe, people shouldn’t be losing their jobs refusing to take it ¹. And if we know it is safe, but it is not approved, we need to figure out a process by which what we know actually factors into the decisions made.

There are two strong counterarguments to this: First, you can’t change the process mid-stream. Second, the process works in most cases which means it might be a bad idea to change it for the odd pandemic case.

You shouldn’t change the rules midstream

It’s quite understandable that the FDA should not unilaterally change the definition of approval to suit a particular drug that is not meeting the usual standards as fast as we would like. I’m not sure that you are duty-bound, however, not to recognize that the current system is inadequate and needs to be changed immediately. I strongly believe if there were no EUA by which we could access the vaccines, they’d have invented one by now midstream or no. There is a balance between not wanting to tailor the process to a specific outcome in a particular case, and being responsive to problems as they are seen. It’s entirely possible that the right balance here is that we change the rules going forward but not for drugs currently under review. That would be pretty reasonable. But if that’s what we should do, we should be talking about it so that we know the lack of approval is due to a system that needs to be revised. I believe we should also live with the consequences of that system, though, including a more limited ability to mandate its usage until full approval comes.

Tough cases make for bad regulatory code

There is some truth to this as well. Most drug approvals are not like this one and if we cut corners on this those cut corners might be approved for important but less urgent things like prescription fungal cream, erectile dysfunction or cycle regulation where we want to wait for a more thorough examination before approving it. However, I don’t think of this as lowering standard of approval as much as adding another avenue for approval. In this case, it’s an avenue that it will be hard for other drugs to use. We know what we do about the safety of the vaccine for a very specific reason: They’ve been given millions and millions of times over. It has had a more thorough investigation than a lot of the drugs going through the regular process. We may be less certain of the long-term effects because it’s new, but that’s going to be true for a lot longer than we are going to want to leave it without approval². There is, for any drug, the possibility that it could create problems down the line. You can’t go down the line infinitely, however. So, if you were to add a provision that allowed full approval on account of massive real world usage, fungal cream wouldn’t apply. It would take a case very much like this one.

There is also a common not great argument.

Changed, faster process will lack credibility

It is true that a faster process inherently means less investigation. If we go through the whole process with the vaccines, we will indeed have both investigative and real world data compiled, which is more than we will have if we let the latter substitute for the former. The main problem with this is that it is built around the notion that we must uphold a process we are telling people they must ignore. It is incredibly unclear to me that having a rigid process that is ignored³ is as respectful to process and procedure than following them to the letter but cheating in the meantime. If you’re worried about institutional authority.

People citing lack of FDA approval will just start citing sped-up process

Probably. A lot of them, anyway. But let them. As I said above this isn’t an exercise in how to win over the unvaccinated. I’d much rather defend this than a drug the FDA won’t really stand behind. They’ve basically outsourced faith that it is safe and effective to the citizenry, businesses, and employers. Meanwhile they get to be as officious as they want without the blowback they’d be enduring if we didn’t actually have access to it or if they’d put their name on a drug that turned out bad. The accountability to authority ratio here is pretty solid, from their perspective.

I have a tendency to make simple things complicated, but to me this is whole complicated situation has one very simple component: FDA approval should reflect what the FDA knows about the safety and efficacy of a drug. If it knows a drug is safe and effective, it should be approved. If it is not approved, it should be because we don’t know enough to know its safety or efficacy (or both). And if only fools and knaves believe what the FDA officially says about a drug (or requires drug manufacturers to say), that reflects poorly on the FDA. It is untenable to argue that the system must be ignored to be preserved. That “approved by the FDA” is a statement that simultaneously means everything and nothing. At once a gold standard and a technicality for pedants.

Whether it’s a small tweak that allows an alternative path towards full approval, or an overhaul of the system wherein we tier ongoing approval, or somewhere in between, this is a problem that needs to be addressed.

So, to all of you: Please get vaccinated, if you are not already. Outside of rare circumstances, you’re safer for having done so and it will help prevent severe infection and it will help reduce transmission. Please ignore the regulators’ failure to declare this drug safe and approved.

And to the FDA: I shouldn’t need to say that.

1. Also from the labeling is that you have an option to take or refuse the vaccine… which is only true if you don’t mind losing your job. That sort of thing is often considered a form of coercion.
2. It is also the case that generally when side effects happen with vaccines, they happen quickly. It is extremely unlikely there will be a hidden side effect that will manifest itself in a decade or two.
3. One might argue that it’s not being ignored because there is the EUA and that means we can use it. But I say “ignored” instead of “violated” for a reason. We’re not violating their rules, but we are ignoring why many of those rules – the ones that pertain to full approval – are in place and we are ignoring what the FDA actually has to say about what the lack of approval actually means.