Truth in Medicine
Should the FDA prohibit unproven treatments?
Vox has published an interesting interview with University of Miami chief of hematology Mikkael Sekeres, who argues that the FDA should ban ineffective drugs like phenylephrine:
By keeping these ingredients in drugs and telling patients that they’re going to help them, we’re lying to people.
It used to be acceptable for hospital formularies to carry the drug “obecalp.” If you type it on your computer and read it backward, you’ll see what it is: placebo.
That’s not ethical! It’s not ethical to lie to patients. And it’s not ethical to lie to patients by giving them obecalp in a hospital, just like it’s not ethical to lie to patients and say that phenylephrine is going to help them with a cold.
The puzzling thing about this passage is that placebos, famously, do help people. So it’s not a lie to give patients placebo and tell them it’ll help. It likely will! It would be a lie to claim that the mechanism is pharmacological, but presumably one need not make any such specific claims while recommending a placebo.
Perhaps the worry is that it is “lying by omission”—patients may be expected to make mistaken assumptions about the mechanism by which it helps—but such mistaken assumptions only seem problematic if they undermine the rational basis of the patient’s choice, and in this case there’s no obvious reason why the details of mechanism should matter. (People can dispute the precise neurochemical mechanism by which SSRIs help with depression, for example, without this undermining their rational and autonomous decision to take the medicine.)
But even this moral risk could presumably be avoided. Obecalp could, for example, be introduced as an “alternative” medicine that doesn’t work via standard pharmacological mechanisms but nonetheless has a long and well-verified history of helping many individuals who try it.
Sekeres continues:
We’re empowering consumers to take the right drug… When the FDA removes a drug from the market, they’re protecting the health of the public—and they’re protecting truth in medicine.
There are less obstructive ways to share information. They could, for example, simply require a prominent label: “The efficacy of this drug has not been established by the FDA.”
Phenylephrine seems pretty low-stakes, but there are higher-stakes cases in which I would care more about the issue. For example, I think patients should be allowed to access experimental vaccines and treatments even before their efficacy is proven to the FDA’s satisfaction (so long as this limitation is clearly communicated to the patient, of course).
The FDA should “protect the health of the public” by providing the public with information that can help guide our choices. It is objectionably paternalistic—and sometimes, extremely harmful—for the agency to try to pursue this goal by limiting our options, at least when the option in question could reasonably be regarded as having positive expected value: e.g., a reasonable chance of helping, and comparatively low risk of harmful side-effects. (I’m fine with banning anything that clearly does more harm than good; but that’s a very different standard from how the FDA currently operates.)
Put in argument form:
The FDA should not prevent patients from accessing treatments that have positive expected value for them.
Some unproven treatments have positive expected value.
So, the FDA should not blanket prohibit unproven treatments. (They would do better to only prohibit treatments that clearly do more harm than good.)
In a better world we'd abolish the FDA. It does far greater harm by slowing down medical innovation than it does good by preventing bad drugs from coming on the market.
I completely agree although I don’t think the FDA should exist at all precisely because issues like this and far more and worse that the FDA has aren’t just unlucky but *predictable* given the inherent institutional incentives.