Scott Alexander on the FDA

Scott Alexander has a new post on our highly dysfunctional FDA. He starts with the debate over the new Alzheimers drug, and then explains how FDA errors led to needless delays of Covid testing and vaccines, which caused thousands of unnecessary deaths.

While that discussion is well worth reading, Alexander was just warming up:

I worry that people are going to come away from this with some conclusion like “wow, the FDA seemed really unprepared to handle COVID.” No. It’s not that specific. Every single thing the FDA does is like this. Every single hour of every single day the FDA does things exactly this stupid and destructive, and the only reason you never hear about the others is because they’re about some disease with a name like Schmoe’s Syndrome and a few hundred cases nationwide instead of something big and media-worthy like coronavirus. I am a doctor and sometimes I have to deal with the Schmoe’s Syndromes of the world and every f@$king time there is some story about the FDA doing something exactly this awful and counterproductive. For example, there are only a few hundred cases nationwide of Infant Short Bowel Syndrome, a condition where some babies cannot digest food effectively. You can save their lives by using an IV line to direct nutrients directly into their veins, but you need to use the right nutrient fluid. The FDA approved an early draft of the nutrient fluid, but it didn’t have enough fish oil, which is necessary for development, so a lot of the babies still died or ended up with permanent neurological damage. In the 1990s, researchers figured out what was going on and recommended adding fish oil to the IV fluid. The FDA responded that they had only approved the non-fish-oil version, it would take them a while to approve the new version, and until they did that adding fish oil was illegal. A bunch of babies kept dying and getting permanent neurological damage, and everyone knew exactly how to stop it, but if anyone did the FDA would take away their licenses and shut them down. Around 2010, Boston Children’s Hospital found some loophole that let them add fish oil to their nutrient fluid on site, and infants with short bowel syndrome at that one hospital stopped dying or ending up permanently disabled, and the FDA grudgingly agreed to permit it but banned them from distributing their formulation or letting it cross state lines, so for a while if you wanted your baby not to die you had to have them spend their infancy in one specific hospital in Massachusetts. Around 2015 the FDA said that if your doctor applied for a special exemption, they would let you import the correct nutritional fluid from Europe (where, lacking the FDA, they had just added fish oil to the fluid as soon as researchers discovered it was necessary), but you were only able to apply after your baby had already sustained serious damage, and the FDA might just say no. Finally in 2018 the FDA got around to approving the corrected nutritional fluid and now babies with short bowel syndrome do fine, after twenty years of easily preventable state-mandated deaths. I CANNOT STRESS ENOUGH HOW EVERY SINGLE THING THE FDA DOES IS LIKE THIS ALL THE TIME.

Obviously there’s a bit of hyperbole there at the end, but later on he has a nice explanation of why the problem is not the specific people that work at the FDA, rather it’s the incentive structure:

I want to stress that, despite my feelings about the FDA, I don’t think individual FDA bureaucrats, or even necessarily the FDA director, consistently make stupid mistakes. I think that given their mandate – approve drugs that definitely work, reject ones that are unsafe/ineffective, expect people to freak out and demand your head if any unsafe/ineffective drug gets through, nobody will at all no matter how many lifesaving treatments you delay or stifle outright – they’re doing the best they can. . . .

And it’s hard to even blame the people who set the FDA’s mandate. They’re also doing the best they can given what kind of country / what kind of people we are. If some politician ever stopped fighting the Global War On Terror, then eventually some Saudi with a fertilizer bomb would slip through and kill ~5 people. And then everyone would tar and feather the politician who dared relax our vigilance, and we would all restart the Global War On Terror twice as hard, and drone strike twice as many weddings. This is true even if the War on Terror itself has an arbitrary cost in people killed / money spent / freedoms lost. The FDA mandate is set the same way – we’re open to paying limitless costs, as long as it lets us avoid a very specific kind of scandal which the media will turn into 24-7 humiliation of whoever let it happen. If I were a politician operating under these constraints, I’m not sure I could do any better.

If you are confused by Alexander’s reference to media irresponsibility, look at how the media is hyping a few cases of vaccinated people getting Covid.

As with Matt Yglesias’s posts on passenger rail and Razib Khan’s posts on woke excesses, one ends up feeling a sense of almost complete hopelessness after reading Alexander.  And that’s why Alexander, Yglesias and Khan are the three Substacks that I read—I don’t want my information sugar coated.