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A Polemic For Why Markets Need CopsProtecting America’s Health: The FDA, Business, and One Hundred Years of Regulation by Philip J. Hilts (New York: Alfred A. Knopf, 2003), 394 pp., $26.95
In his engaging new book on the U.S. Food and Drug Administration (FDA), Philip Hilts wears his credentials and his ideology brightly upon a professional lapel. These two factors—Hilts’ experience and his political tilt—compose at once the strengths and weaknesses of this engaging volume. As to credentials, Hilts is a health and science reporter for the New York Times with more than two decades of experience; he has written some of the best coverage on the FDA. Hilts exploits his broad knowledge of the scientific issues involved, simplifying complex medical and scientific concepts for his readers and making an otherwise difficult subject highly entertaining. He also makes shrewd use of a wide array of contacts in government, the pharmaceutical industry, academe, and consumer protection advocacy groups. His chapters on "The Medical Reviewer" and "The Plague" are two of the best portraits of FDA decision making and the federal government’s response to AIDS yet published. As to ideology, Hilts is a strong believer in the FDA and in consumer protection more generally. He openly decries the efforts of "conservatives" to "deregulate" the pharmaceutical marketplace by restraining the FDA or attempting to abolish the agency altogether. To his credit, Hilts discloses his biases for readers; the book openly mixes journalism and polemic. And the polemic is useful. Hilts reminds his readers that pharmaceutical tragedies are not limited to the case of thalidomide. He catalogs a number of bad drugs—Upjohn’s Panalba, antiarrhythmia agents Tambocor and Enkaid—that were poorly researched and killed or maimed thousands. And he is capable of balanced consideration: Quicker approval with labeling might work if doctors heed the necessary warnings (p. 234). On the debit side, the book has its share of avoidable historical errors, and they come early and often. Hilts waxes romantic about "this little bureau" that "began in the nineteenth century with a few scientists at the Bureau of Chemistry in the Department of Agriculture" and was later "transferred from the Agriculture Department to the federal department of health—called Health, Education and Welfare" (pp. xii–xiii). In fact, there was no "Bureau" of Chemistry before 1901, only a "Division" (a unit with far less authority and funding than other USDA bureaus had). And between the Agriculture Department and HEW, the FDA spent a critical thirteen years (1940–1953) in the Federal Security Agency, during which it broke free from USDA oversight, boosted its personnel force by more than 50 percent, centralized and standardized its field operations in a critical reorganization (1948), began systematic product recalls and criminal fines, and sharply stemmed the flow of new drugs approved (from 1,026 in 1940 to 305 in 1953). Indeed, it was during these crucial years that the FDA largely regulated the patent medicine industry out of existence. Among other errors, Hilts refers (p. 352) to "commissioner" Carl Alsberg (1912–1923) when no such post existed until the 1940s. Finally, in his otherwise informative summary of drug approval (Chapter 15), Hilts materially underestimates the number of FDA personnel involved in a new drug review (p. 229: Hilts says four; it’s more often eight to ten, often with more than one medical reviewer). Perhaps more frustrating is Hilts’ occasional failure to follow his excellent journalistic nose more thoroughly. He blithely refers to the rules governing clinical trials and new drug review without conducting new research on them. The regulations elaborated by the FDA in the wake of the Kefauver-Harris Amendments of 1962 stand as perhaps the most consequential administrative rules in our nation’s history. They fundamentally shaped (by some accounts, gave birth to) contemporary medical research and the modern clinical trial industry. Where did the administrative rules concerning drug regulation and clinical trials come from? Who wrote them? Who lobbied for what, and with what success? Hilts refers repeatedly to these crucial rules without giving the reader a sense of their history, their politics, or their basis in science. Finally, a reflection on the road not taken here. The argument driving Protecting America’s Health is that the health marketplace needs a cop, and Hilts defends this proposition with flair and vigor. Yet Hilts frames the fundamental conflict in highly Victorian terms: We need cops because there are "criminals" (unscrupulous drug companies) seeking to defraud the "innocent" (consumers). One could just as easily argue that the structure of the pharmaceutical marketplace leads to inadequate provision of information, stemming not from underlying corporate "evil" but from the inherent uncertainty that firms themselves have about the quality and safety of their products and the difficulty that consumers face in processing medical information. Seen in this way, Hilts has overlooked some of the key costs and the key benefits of modern drug regulation. The ignored benefit is consumers’ (and physicians’) confidence in new pharmaceutical products. Hilts consistently posits the trade-off as one between industry profits and consumer safety, but he might have pressed a different claim—namely, that FDA regulations reduce the uncertainty over product quality and hazards (he hints at this on p. xiv and then basically drops it), and thereby contribute to both firms’ profitability and consumers’ welfare. The ignored cost is that patients are a variable lot and that a successful drug may work for some of them and not for others. Under these conditions, the fact that a new drug comes along and that "there [are] already five others on the market" does not mean that the new product is "not particularly needed" (p. 232). There may a sizable patient population for whom none of the existing therapies work, and indeed much of drug development aims to identify therapies that work specifically for drug-resistant populations. Hilts might properly reply that such concerns warrant another, different book. As for this one, it is a valuable guide to one of the most important and least understood agencies in U.S. government.
Editor's Notes Daniel Carpenter is professor of government and a member of the Standing Committee on Health Policy at Harvard University. He is author of the award-winning The Forging of Bureaucratic Autonomy (Princeton, 2001).
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