« I'm Not Joking: Abolish the FDA | Main | More on the FDA» Don Boudreaux

November 22, 2004

Why Trust Strangers with Your Health?

Don Boudreaux

Man knows so little about his fellows. In his eyes all men or women act upon what he believes would motivate him if he were mad enough to do what that other man or woman is doing.

                             – William Faulkner, Light in August

I continue to receive skeptical responses to my suggestion that the FDA should be abolished. What’s surprising is that almost all of these responses are from friends and acquaintances who are favorably disposed toward markets and liberty.

Of the 16 e-mails (and three comments at the Club for Growth site) that I’ve received, all but three express wariness of the idea of a USA without the FDA.

Central to my case is the fact that no drug or foodstuff is 100% risk-free. (I’ll talk here exclusively of drugs, but all that I say, with some minor modifications, can be applied to foods.) If every drug is somewhat risky, what set of guidelines is the FDA to use in determining if a drug is “safe” enough be approved for sale?

Nearly all popular discussions of the FDA proceed as if identifying the level of riskiness that distinguishes “unsafe” from “safe” drugs is a question of science. It is not. Science’s job here is to give an accurate assessment of the range of riskiness and of effectiveness of each drug. But whether any drug is “safe” or “unsafe” is inescapably a question of human judgment. And making this judgment wisely requires knowledge not only of a drug’s riskiness and effectiveness, but of each user’s likely reaction to a drug – and, importantly, of each user’s subjective demand for the drug.

Each of us differs in our willingness to take risks. There is no “right” level of risk tolerance. A very ill mother of young children can rationally and reasonably choose to take a drug with, say, a 35% chance of serious side effects if this drug is her only hope of surviving, while a less-ill retiree might, with equal rationality and reasonableness, choose to avoid the drug. No team of even the smartest and most altruistic bureaucrats in Washington can have sufficiently detailed knowledge of each American’s risk-tolerance and other relevant circumstances. Yet such knowledge is exactly what is required to determine if a drug’s riskiness, relative to its likely effectiveness, is too great or not.

The answer to the question: “Is drug X too risky?” is inherently individual and subjective. The appropriate question that must be answered is "Is drug X too risky for Ernie (or Sally or Randy or....) given his or her tolerance for risk and other personal circumstances?"  Only Ernie can answer this question for Ernie; only Sally can answer it for Sally.  Only Randy can answer it for Randy.

When this fact is combined with the understanding that each of us differs from the other, it is impossible – not unlikely, but impossible – for a single, centralized decision by third-person bureaucrats to be anything but arbitrary.

Posted by Don Boudreaux in FDA, Regulation | Permalink

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