A Hard Pill to Swallow

Taking Your Medicine: Drug Regulation in the United States, by Peter Temin, Cambridge: Harvard University Press, 1980, 281 pp., $18.95.

This tremendously valuable book clearly presents the distressing history of US drug regulation. It is must reading for those interested in health care or the role of government regulation. Although the history and interpretation are extremely informative and well done, I am not so enthusiastic for the meta-theory of human behavior presented in the book, even though some of the behavioral and institutional classifications are useful. Temin's own policy proposals are provided little space and less emphasis. He favors very slight movement in the direction of freer drug markets, allowing more consumer and physician choice.

The book contains a wealth of historical and interpretative materials, ranging from the epidemiology of drug risk to the bizarre legislative history of the key Food and Drug Administration legislation and the economic literature on the 1962 FDA amendments. This diverse material is shown to be important to understand drug regulation. Further, Temin handles this complex material masterfully.

Temin shows that federal drug regulation has been persistently based on the elitist assumption that consumers cannot choose drugs for themselves. Since 1962 this assumption has been extended to physicians, as well. Government "aid" is required. He shows that the regulators have aggressively promoted this view and the rules to enforce it. They have shaped legislation to give themselves the most possible power. In particular, the regulators have repeatedly managed to harness public outcries to achieve their own agenda of tightening government control over drugs, in spite of the lack of connection between the public's concern and regulators' goals.

The most fascinating example was the creation of the now crucial distinction between prescription and nonprescription drugs, coming almost as an afterthought and achieved by administrative rule making in the wake of the 1938 legislation. (The legislation itself was irrelevant to the drug disaster that spawned it.) The rule created almost no controversy. The FDA apparently thought that it would apply only to a very small category of drugs that it believed were too potent to allow in over-the-counter sale but not too dangerous to be used with benefit. Thus, the assumption that doctors know what is good for us was casually introduced for a minor number of drugs. The therapeutic revolution since World War II has expanded this minor category into the major category of useful drugs.

Temin shows very convincingly that doctors do not act as well-informed purchasing agents, carefully balancing risks and benefits for their drug-using consumers. Further, he demonstrates in graphic detail that the necessary information on the comparative risks and usefulness of drugs simply does not exist for most drug products and that, even where it does, the nonscientific (particularly, nonstatistical) training of physicians does not prepare them to evaluate it. Further, the treatment of drug risk in the medical literature is shown to be almost unbelievably sloppy and casual. For example, the small risk of blood disease from chloramphenicol receives a great deal of attention, while the similar risk of allergic reaction to penicillin is only mentioned in passing.

As Temin points out, the FDA's drive to control which drugs may get into the control of doctors is based on an analysis similar to the above. The very difficulty of physician choice of drugs, however, has some very damaging implications for the drug regulators' case.

First, the information on which to base a judgment of the relative benefits and costs of drugs, especially the formal evidence generated by experiments, is very poor. The FDA itself must rely on extremely poor information, so that its judgments are very likely to be poor. Surely the case for FDA control should depend on the quality of information available to the regulators being superior to that available to consumers or physicians. For the most part, Temin shows this to be untrue; yet he fails to draw the natural implication that this lack of knowledge undermines the most fundamental argument for government intervention in the drug market.

Second, while the FDA has moved since 1962 to limit doctors' freedom to choose drugs, the cornerstone of official regulatory policy is to transfer the responsibility of choosing drugs from consumers to physicians. (Temin gives this less attention—probably because the slowdown of new drug development and marketing due to the 1962 FDA amendments has received most of the attention of economists and physician-regulation critics.) Indeed, the vast majority of useful drugs are allowed on the market only under physician control. In fact, however, doctors do not scientifically evaluate the drugs but rather make choices based on customary use. And since the case for transferring consumer choice to physicians must rest on the superior knowledge of physicians, this argument appears to crumble. After all, consumers can perfectly well follow customs, as transmitted by pharmacists, physicians, and other consumers. Who needs a doctor for that?

In view of Temin's documentation of the outrageous usurpation of consumer choice by the drug regulators over the years and the laughably slim scientific basis for it, most readers will be shocked to find Temin's policy proposals so tame. He would create a new category of drugs conditionally released (before all information is in to the FDA) in combination with a recertification test system to be sure that doctors have some minimum drug knowledge. Oh, well, Doctor Temin's diagnosis is so well-done that he may be cheerfully forgiven for prescribing a therapy that seems too mild.

H.E. Frech is a professor of economics at the University of California, Santa Barbara.