The FDA Could be Better, But Nobody Will Ever Ask Them to Be

Here’s a fun modified version of the trolley problem: You are cruising along in the Trolley, as one does, and look ahead to see 2.6 million people on the tracks; the Trolley is set to roll over all of them. To be fair, you are only guessing at that 2.6 million figure - the Trolley is still distant enough that your best estimate is probably somewhere between one and five million; it will only be later that you learn the exact figure, but it’s by no means unclear that you are dealing with “population of a major metropolis” type numbers on your current track.

As you’d expect, there’s a switch you can throw to change tracks. You look to your left (in my mind the Trolley always veers left, don’t ask me why) and there’s about 8,000 people milling around - none of them are on the track, but jostling is occurring. It’s vaguely possible someone might get pushed in the way of the Trolley.

It’s also worth mentioning the tracks are pretty close together; nobody is completely safe on either track should things go wrong. On the first track, the people are stacked up pretty deep, so if you hit them there’s going to be some spillover onto the diversion track that could cause death on the second track even if you don’t switch. This is torturing the living hell out of the metaphor, but also imagine that the Trolley has some automatic safeguards that would switch it back to the main track should things start to go really bad on the second track - I.E. if you managed to hit a couple hundred of people on the second track somehow, you’d kill them plus the entirety of the first-track folks. It’s also possible that the switch on the tracks will malfunction and you won’t change tracks at all, but nobody expects this to happen.

Sitting there, you consider that entire tortured metaphor and come to the conclusion that the correct choice is to switch tracks - it’s incredibly likely doing so will save millions of lives. In the lottery-ticket-odds worst case scenario, a couple hundred extra people die, but in any likely world you are saving a multitude.

Only two things stand in the way of you making the clearly correct choice. First: although both tracks go directly to your destination you usually use the first track to get home, and it’s become a bit of a habit for you. Second: you know from experience that your boss tends to blame everything on the Trolley, not the driver; the one exception to this is when track-switches are involved, in which case he reverts to blaming the conductor. You don’t want to deviate from your habits or get fired, so you make the decision to kill a couple million people to preserve your own comfort. They die horrifying deaths.

Over the coming weeks, you half-expect someone to show up and complain about this - after all, you did exterminate an amount of people equivalent to half the population of Norway for next to no reason at all. But despite the fact that you are on the top ten list of historic murderers when judged by kill-count, you find that people actually pop out of the woodwork to defend you - experts from around the globe point out that you ALWAYS take the first track home, and it would be absolutely crazy for anyone to even suggest a track-change.

The more observant among you might have picked up on this already, but I’m slightly salty towards the FDA and the global health community at large lately.

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I want you to clear you mind of everything you know of last year and Covid. I know it’s hard, but do it anyway.

Pretend it’s January 2020. You have been summoned to a summit of the world’s leaders and top health officials. They explain that there’s a pandemic coming - it’s not sure yet how many people it will kill, but it’s pretty clear it’s going to be a lot. They explain that the world’s best scientists have already developed a vaccine that’s pretty much sure to work. It won’t save everyone, they say, but getting it into production quickly could potentially save millions of lives. There’s a small chance the vaccine won’t work and an even smaller chance it will be harmful, but the expectation is it will work just fine and be about as harmful as every other vaccine - i.e. not harmful at all.

For whatever reason they are giving you, a layman, control of how it will be tested and how soon they will allow it to be released. You have fiat powers over the entire process.

If you are a normal person thinking in a normal way, it’s likely you come up with something like this: You announce to the world that the pandemic is coming and that it has the potential to be very, very bad. You put out a call for volunteers to test a potential miracle drug. You explain that the fastest way to test the vaccine is to dose people with it, wait for it to come into effect and then expose them to the virus.

You have your teams of scientists explain to any volunteer who shows up (tens of thousands do) that there is a small but non-zero chance that they might be seriously harmed by the vaccine or that the vaccine might not protect them from the virus, which carries it’s own risk. You hire a team of psychologists to confirm that your brave test subjects are truly cool with this, and they are.

You start out small by dosing a couple hundred of the bravest and wait a couple of weeks to see if the vaccine causes any significant harm - it doesn’t, besides the usual mild side effects. You then dose a couple thousand more people, and expose them to the virus after it’s in full effect. Two weeks later, you know if the vaccine worked or not. Assuming you started on the first of February, it’s now about mid-March. You can continue to test the rest of your volunteers to make sure, but you now know with a reasonable certainty that you have a drug that’s both safe and effective.

Getting the vaccine into significant production by May is not out of the question; you order it done. Hell, you pay for it to be done, if you have to. There’s millions of lives at stake!

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The above is a fantasy, of course. The FDA did their normal, exhaustive battery of test. No vaccine was approved until seven months after our fantasy-timeline. Since basically the every other country uses the “approve whatever the FDA approved” drug approval process, millions of people died for no reason beyond institutional inertia.

I want to re-emphasize: We knew those people would die if we didn’t change anything. We decided, as a society, that they absolutely should die so we could prevent a risk we always knew to be very small to a couple thousand willing volunteers. We are very good at making vaccines, and we pretty much understand the risks and chances of efficacy - nobody expected any of the vaccines to be dangerous or ineffective. We just decided to check anyhow and take our sweet damn time at it.

Maybe I’m being unfair. What if I’m wrong and we aren’t really all that good at vaccines or drug testing, and every single minute of that time was absolutely required to prevent a catastrophe? For your answer, jump on your favorite search engine and try to find vaccine trials that went wrong - it’s hard. It’s hard in a way that strongly implies that this basically never happens. As a for instance, this author of this article was terrified that Trump might push through a vaccine too soon, and in searching for examples to prove how dangerous this would be apparently couldn’t find anything more recent than 1976. Or this comment, menacingly referencing a failure as recent as 1966. The latter author says this:

While there is a need for caution, the need for accelerating testing is clear, and many discussions are occurring on how to ethically perform experimental infection studies in humans. Such studies provide enormous progress in vaccine research, but of course the extreme risks must be weighed against potential benefits.

Note the trick phrasing: We knew for certain that if uncheck Covid would kill multitudes, but the “extreme risks” are with a class of drugs so safe he can’t find an example of a clinical trial going wrong in the last fifty years. When I said people would pop out of the woodwork defending the Trolley driver, I was being charitable; what was more common was someone like this guiding the hand of the driver, urging him to trade a small risk to a small group in for the assured fatality of millions.

You might say I’m being too harsh on the FDA - after all, I’m implying they do this out of bare self-interest and a complete lack of concern for widespread preventable death. But it’s not hard to show that this is just who they are at a very fundamental level, that this is simply their culture and what seems normal to them. This link works as a good summary of how normal this is - the FDA sitting back, delaying inspections, refusing to approve tests we need, and just being generally willing to accept any level of human death and suffering so long as it prevents even the smallest of risks to their health or careers.

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It’s not hard to imagine a sickness worse than Covid, which is very survivable for anyone younger than middle aged. But we don’t have to go even that far in our imaginings; we are already watching as mutations appear that our current vaccines are less effective against:

“If the rampant spread of the virus continues and more critical mutations accumulate, then we may be condemned to chasing after the evolving SARS-CoV-2 continually, as we have long done for influenza virus,” the authors warn. “Such considerations require that we stop virus transmission as quickly as is feasible, by redoubling our mitigation measures and by expediting vaccine rollout.”

Let’s say we get this bout of Covid under control and a year or so down the line a new illness of similar proportions starts making the rounds, threating a duplication of the same massive loss of life we’ve already seen. Ideally we would hope that our response would be quicker, that we’ve learned our lessons regarding comparing risk and we are prepared to let willing volunteers take the small risks necessary to prevent another couple of million of people from dying. That’s not going to happen. Those millions of people are going to die - it’s not a question of if, just a question of when the next disease comes around.

The FDA isn’t incapable of learning, mind you - it’s just that we are teaching them the wrong lessons. I’m probably a lot more libertarian on the subject of medical regulation than most of you, but people like me who sit around reading studies for no reason have always harbored a secret hope that other people might come around to the insanity of how slow and expensive the FDA process is and how unwilling to keep up with science they’ve proved. I can’t pretend there’s any chance of that anymore - we’ve just seen a pandemic sweep the world and the FDA absolutely refusing to budge in the slightest to hurry things up, and the messaging from the people has been clear: We could give a shit. We’ve been locked in our houses for a year while a couple million of us choked to death; a substantial amount of this could have been avoided if the people in control of our cures showed the slightest flexibility, and nobody made a peep. As a people, we don’t care.

There’s a long-standing entrenched culture at the FDA that understands that the only scenario in which they get in any trouble is something like “drugs we approved turned out badly”. This isn’t an unjustified belief - even before Covid, the average person’s interest in drugs that should be available but aren’t due to bureaucracy was near nil. The wisdom of the tactic of being supremely careful in a way that ensures have not been confirmed for them before, but now it’s absolutely sure; there’s no amount of death sufficient for us to ever speak at all, let alone loudly enough to create any likelihood of change. We are as completely unprepared for the next pandemic as we were for Covid. It will happen again in the same way with the same delays, and we’ve already proven we won’t mind. We will act shocked at the death, but there should really be no surprise when the people who hold the keys to the medicines that could stop this refuse to swerve the Trolley - from their perspective, there’s simply no reason at all for them to ever switch tracks.