FDA vs. the Individual - Pharmaceutical Executive


FDA vs. the Individual

Pharmaceutical Executive

As a matter of social welfare, the right decision should be to balance both types of errors, so as to minimize the total number of lives lost or seriously damaged. In making this decision, the mechanism of causation—whether the harm inflicted or benefit denied—should be regarded as utterly immaterial to the ban decision, for that is the way in which rational patients would so regard it.

Individuals seeking to maximize their expected utility will be willing (in the simplest case) to take a 90 percent risk of death from a given course of action if they believe (ignoring any increment in treatment cost) that the risk of death without that action is 91 percent. That is the decision that they would make with last-ditch surgery, when the FDA is nowhere to be found. It is the same decision people should be allowed to make with drug use.

The key question is whether FDA has incentives to make choices that capture the desire of any individual to maximize expected utility of alternative courses of treatment (or, as we laymen say, give us the best chance to get well).

The answer has long been understood to be no. The key lies in the difference between visible and nonvisible harm. When thalidomide leaves children with deformed limbs, harm is easy to see and easy to assign to a given therapeutic agent.

Its virtues, which turn out to be real, are largely ignored until tempers cool, when, rechristened Thalomid, it is reintroduced into the market as an effective treatment for an after-effect of leprosy.

The FDA catches all sorts of grief for decisions that let drugs on the market, which means that the agency rates Type I errors at a substantial multiple of Type II errors. The upshot is that too many products are kept from the market as the FDA attempts at all costs to avoid causing visible harm, without taking into account the losses that must be absorbed by delaying or removing products from the marketplace.

The calculus of costs and benefits routinely differs significantly across individuals, for any number of sensible reasons. The first and most obvious is that no two individuals are precisely alike in their need for or tolerance of particular lines of treatment.

The simple truth that dominates this principle applies to any attributes in all populations: for any trait in any population the variation around the mean is always greater than zero. In ordinary English, this means that all individuals in the population are not 5 feet 7 inches tall simply because the average person is of that height. It also means that subpopulations—men and women, for example—could have both different means and different variances about those means.

What is true of height is true of toleration of risk, of pain, of aspirin, or of any of the untold factors that go into making a medical decision. The question then is how the inescapable feature of heterogeneity in any population fits into the vital question of whether to prefer monopoly upstream control by the FDA relative to downstream individual control.


The next issue is whether these differences can be perceived and acted upon by individuals, either alone or in conjunction with their physicians. Medical questions are never trivial, even for patients who have access to professional help.

The competence of ordinary people to enter into contracts or to make personal decisions is usually not worth a second thought. But weakened capacity often is the critical issue for individuals of advanced age or declining health. That reality is in real tension with the sensible view, taken by courts in medical malpractice cases, that each individual has sole power to determine whether to submit to invasive surgery or any other treatment by his or her physician.

It is often claimed that ordinary individuals are not only unable to make the correct decisions, but they are equally unable to find suitable proxies who are capable of making good decisions for them. Matters are only made worse, the argument continues, because the pressure of modern medicine are such that physicians do not spend needed time with patients, even when it might improve overall performance. Worse still, there is not a viable system of medical malpractice or professional discipline to separate weak from able physicians.

My sense is that all these arguments, while true, are overdrawn, for their dreary tone cannot explain the many success stories in medical treatment over past years. But even if they were all correct on a descriptive level, they would not lead to any change in overall policy.


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