Regulatory Capture the FDA

Libertarians love to complain about regulatory capture. Here’s how it happens: The government doesn’t like how some industry is going, and decides to regulate it. But the regulatory agencies have to hire from somewhere, and the companies under regulation aren’t fools. Over time they find ways to staff the regulatory agencies with their own people. Eventually the regulated industry ends up in charge of “regulating” itself, and the government provides a huge subsidy in the form of all the rubber-stamping sinecures at the captured regulatory agency. To some people, this process looks all but inevitable, and it offends libertarians because it creates huge amounts of bloat with no benefit to the public.

Libertarians also love to complain about the FDA. But as Scott Alexander points out in a recent post, actually abolishing the FDA would be a huge headache, much more trouble than it’s worth. “Full abolition of the FDA would have domino effects on every other part of healthcare,” he argues. “You would have to reform the insurance system, the War on Drugs, the medical evidence system, the malpractice system, and the entire role of doctors. All of these other things are terrible and should probably be reformed anyway. But you’d have to do it all at the same time, and get it all exactly right.”

In our opinion, these two problems go together like sodium and chlorine — volatile chemicals on their own, but forming a useful salt when combined. Federal agencies are hard to remove. But they are relatively easy to capture. 

Instead of trying to destroy the FDA, libertarians and other sympathetic movements, like effective altruism, should try to regulatory capture it. And when they do capture the FDA, Scott Alexander is the man to run it [1].

Scott checks all the boxes. He’s a practicing physician, and well-versed in medical research. He has an extreme skepticism of regulation, but understands that actually running the FDA into the ground would be a bad idea. He knows much more than you wanted to know about all kinds of medical situations. The current FDA Commissioner seems like a solid career guy, but he’s not J. Edgar Hoover. We’re sure that if Scott starts making overtures now, President Swift will be willing to appoint him when she takes office following her landslide victory in 2028.

Grimes can make the introductions

We understand that Scott might feel hesitant, but taking control of the FDA would be a much more effective and only slightly more painful act of charity than donating a kidney. Also, you will one-up Dylan Matthews forever, we’d like to see him beat this one. 

And we have to point out — if regulatory capturing the FDA is possible, then for an effective altruist, making it happen might actually be a moral imperative. 

If Scott were the head of the FDA, he could do things like…

Approve normal right-handed ketamine and let doctors prescribe it in a way that makes sense.

The FDA, in its approval for esketamine, specified that it could only be delivered at specialty clinics by doctors who are specially trained in ketamine administration, that patients will have to sit at the clinic for at least two hours, and realistically there will have to be a bunch of nurses on site. 

… 

They want to make sure no patient can ever bring ketamine home, because they might get addicted to it. Okay, I agree addiction is bad. But patients bring prescriptions of OxyContin and Xanax home every day. Come on, FDA. We already have a system for drugs you’re worried someone will get addicted to, it’s called the Controlled Substances Act. Ketamine is less addictive than lots of chemicals that are less stringently regulated than it is. This just seems stupid and mean-spirited. 

I wanted to finally be able to prescribe ketamine to my patients who needed it. Instead, I’m going to have to recommend they find a ketamine clinic near them (some of my patients live hours from civilization), drive to it several times a week (some of my patients don’t have cars) and pay through the nose, all so that some guy with a postgraduate degree in Watching People Dissociate can do crossword puzzles while they sit and feel kind of weird in a waiting room. And then those same patients will go home and use Ecstasy. Thanks a lot, FDA.

Set the standards for a study to approve a cavity-fighting bacterium lower than “impossible”.

Professor Hillman started a company “Oragenics” and applied for FDA approval. The FDA demanded a study of 100 subjects, all of whom had to be “age 18-30, with removable dentures, living alone and far from school zones”. Hillman wasn’t sure there even were 100 young people with dentures, but the FDA wouldn’t budge from requiring this impossible trial.

And approve nutritional fluids that save babies’ lives, or local equivalent, the next time something like this comes up.

My problem is: doing anything in medicine is illegal until you clear a giant hurdle. To clear the hurdle, you have to pay millions (sometimes billions) of dollars, fill in thousands of pages of forms, conduct a bunch of studies that can be sabotaged for reasons like “this drug is too good so it would be unethical to have a control group”, and wait approximately ten years. You have to clear this hurdle to do anything, even the most obviously correct actions. Everything starts out illegal, and then a tiny set of possible actions is exempted from the general illegality. The easiest name for this hurdle is “the FDA”, since they’re the agency charged with enforcing it.

These are just a selection, we’re sure Scott can come up with lots of other creative things to do with this position. He could get to the bottom of the modern IRB debacle. He could arrange it so that the names of new medications all turn out to be horrible stealth puns. You might even be able to get Adderall again!

Some of you may be concerned that his new responsibilities would cut into Scott’s available time for blogging. But we’re talking about a man who kept blogging straight through residency. We are confident that running the FDA would only make his blog posts more interesting. 


[1] : We promise to take down this post before your senate confirmation hearing, though it would be rather diverting to hear Senator Warren ask if you’re in the pocket of Big Slime. But until then, the challenge stands. 

Drugs Fun, Heroin Still Dangerous

Carl Hart is a parent, Columbia professor, and five-year-running recreational heroin user, reports The Guardian. “I do not have a drug-use problem,” he says, “Never have. Each day, I meet my parental, personal and professional responsibilities. I pay my taxes, serve as a volunteer in my community on a regular basis and contribute to the global community as an informed and engaged citizen. I am better for my drug use.”

Hart makes it pretty clear he thinks drug use is a good thing. Good not only for himself, but for people in general. “Most drug-use scenarios cause little or no harm,” he says, “and some reasonable drug-use scenarios are actually beneficial for human health and functioning.” He supports some basic safeguards, including an age limit and possibly an exam-based competency requirement, “like a driver’s licence.” But otherwise, he thinks that most people can take most drugs safely.

The article mentions Hart’s research in passing, but doesn’t describe it. Instead, these claims seem to be based largely on Hart’s personal experiences with drugs. He’s been using heroin for five years and still meets his “parental, personal and professional responsibilities”. He likes to take amphetamine and cocaine “at parties and receptions.” He uses MDMA as a way to reconnect with his wife

When Hart wondered why people “go on [Ed.: yikes] about heroin withdrawal”, he conducted an ad hoc study on himself, first upping his heroin dose and then stopping (it’s not clear for how long). He describes going through an “uncomfortable” night of withdrawal, but says “he doesn’t feel the need or desire to take more heroin and never [felt] in any real danger.”

This is fascinating, but it seems like there’s a simple individual differences explanation — people differ (probably genetically) in how destructive and addictive they find certain substances, and Hart is presumably just very lucky and doesn’t find heroin (or anything else) all that addictive. This is still consistent with heroin being a terrible drug that ruins people’s lives for the average user.

Let’s imagine a simplified system where everyone either is resistant to a drug and can enjoy it recreationally, or finds it addictive and it ends up destroying their life. For alcohol, maybe 5% of people find it addictive (and become alcoholics) and the other 95% of us can enjoy it without any risk. In this case, society agrees that alcohol is safe for most people and we keep it legal. 

But for heroin, maybe 80% of people would find it addictive if they tried it. Even if 20% of people would be able to safely enjoy recreational heroin, you don’t know if it will destroy your life or not until you try it, so it’s a very risky bet. As a result, society is against heroin use and most people make the reasonable decision to not even try it.

Where that ruins-your-life-percentage (RYLP) stands for different drugs matters a lot for the kinds of drugs we want to accept as a society. Certainly a drug with a 0% RYLP should be permitted recreationally, and almost as certainly, a drug that ruined the lives of 100% of first-time users should be regulated in some way. The RYLP for real drugs will presumably lie somewhere in between. While we might see low-RYLP drugs as being worth the risk (our society’s current stance on alcohol), a RYLP of just ten or twenty percent starts looking kind of scary. A drug that ruins the lives of one out of every five first-time users is bad enough — you don’t need a RYLP of 80% for a drug to be very, very dangerous.

Listen, we also believe in the right to take drugs. We take drugs. Drugs good. Most drugs — maybe all drugs — should be legal. But this is very different from pretending that many drugs are not seriously, often dangerously addictive for a large percentage of the population. 

As far as we know, drugs like caffeine and THC aren’t seriously addictive and don’t ruin people’s lives. There’s even some fascinating evidence, from Reuven Dar, that nicotine isn’t addictive (though there may be other good reasons to avoid nicotine). But drugs like alcohol and yes, heroin, do seem to be seriously addictive, and recognizing this is important for allowing adults to make informed choices about how they want to get high off their asses.

Hart’s experience with withdrawal, and how he chooses to discuss it, seems particularly clueless. It’s possible that Hart really is able to quit heroin with minimal discomfort, but it’s confusing and kind of condescending that he doesn’t recognize it might be harder for other people. When people say things like, “I find heroin very addictive and withdrawal excruciating,” a good start is to take their reports seriously, not to turn around and say, “well withdrawal was a cakewalk FOR ME.”

This seems to be yet another example of the confusing trend in medicine and biology, where everyone seems to assume that all people are identical and there are no individual differences at all. If an exercise program works for me, it will work equally well for everyone else. If a dietary change cures my heartburn, it will work equally well for everyone’s heartburn. If a painkiller works well for me when I have a headache, it will work equally well for the pain from your chronic illness. The assumption seems to be that people’s bodies (and minds) are made up of a single indifferentiable substance which is identical across all people. But of course, people are different, and this should be neither controversial nor difficult to understand. This is why if you’re taking drugs it’s important to experiment — you need to figure out what works best for you.

This is kind of embarrassing for Carl Hart. He is a professor of neuroscience and psychology. His specialty is neuropsychopharmacology. He absolutely has the statistical and clinical background necessary to understand this point. At the risk of being internally redundant, different people are different from each other. They will have different needs. They will have different responses to the same drugs. Sometimes two people will have OPPOSITE reactions to the SAME drug! Presumably Carl Hart has heard of paradoxical reactions — he should be aware of this.

On the other hand, anyone who sticks their finger in Duterte’s eye is my personal hero. We should cut Hart some slack for generally doing the right thing around a contentious subject, even if we think he is dangerously wrong about this point.

Less slack should be cut for the article itself. This is very embarrassing for The Guardian. Hart is the only person they quote in the entire article. They don’t seem to have interviewed any other experts to see if they might disagree with or qualify Hart’s statements. This is particularly weird because other experts are clearly interested in commenting and the author clearly knows that they might disagree with Hart. They might have asked for a comment from Yale Professor, physician, and (statistically speaking) likely marijuana user, Nicholas Christakis, who would have been happy to offer a counterbalancing opinion. The Guardian was happy to print that Hart is critical of the National Institute on Drug Abuse (NIDA), “in particular of its director, Nora Volkow”, but there’s no indication that they so much as reached out to NIDA or to Volkow for comment (incidentally, here’s what Volkow has to say on the subject).

We can’t be sure, but it’s even possible they somewhat misrepresented Hart’s actual position. It’s disappointing but not surprising when a newspaper doesn’t understand basic statistics, and it would be unfair to hold them to the same standard we hold for Carl Hart. But it is fair to hold them accountable for the basics of journalistic practice, and it seems to us like they dropped the bong on this one.