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One hundred years of solicitude

Protecting America's Health: The FDA, Business, and 100 Years of Regulation, Philip J. Hilts, Alfred A. Knopf: 352 pp., $26.95

March 30, 2003|Thomas J. Moore | Thomas J. Moore, author of "Prescription for Disaster," is a senior scientist for the Institute for Safe Medication Practices and a health policy analyst at the George Washington University Medical Center in Washington, D.C.

Except for the president of the United States, the toughest job in Washington, D.C., may belong to the commissioner of the Food and Drug Administration. This agency routinely makes decisions that directly affect the health of millions of people. The acceptance or rejection of just one new drug application can influence hundreds of millions of dollars that flow -- or do not flow -- from the pockets of consumers into the coffers of the pharmaceutical industry.

Few passions are more intense (and not necessarily reasonable) than those of frightened people who believe that they may be denied a medicine that they hope might save them or have been given a drug that might kill them. Add to this mix the calculated pressures from a corps of shrewd industry lobbyists who have showered enough cash on Congress and the administration in power to ensure an unholy legion of allies. Stir in ideological preconceptions such as "regulation is bad and strangles innovation" or "drug companies are crooks that exploit the sick." Open this all up to the media spotlight and the result is decision-making under the most challenging of circumstances. (When it took President Clinton nearly three years to replace Commissioner David A. Kessler, the wags explained it was hard to find someone crazy enough take the job but expert enough not to be a danger to him or herself and others in this pivotal office.)

Agency leadership over the last century is one focus of New York Times reporter Philip J. Hilts' new history of food and drug regulation, "Protecting America's Health." He begins with the nation's first food and drug czar, Indiana physician Harvey Wiley, and ends with the FDA's new commissioner, Mark B. McClellan. Hilts has his work cut out for him, given the FDA's wide-ranging responsibility for foods (except meat), drugs, biological products, vaccines, the blood supply, medical devices, microwave appliances and dietary supplements. His result resembles the agency he writes about: substantial strengths mixed with unfortunate weaknesses.

Hilts' primary mission is to document, explain and promote the benefits of food and drug safety regulation. Early on, he identifies his target: "Recently a rump movement in America, led by hard conservatives, has been reviling the consumer protection agencies and refusing to accept science as the basis of policy."

He is referring to the 1990s when the FDA lay squarely in the crosshairs of Newt Gingrich's neoconservative revolution, and he provides point-by-point rebuttals of many of the dubious allegations and outright falsehoods that were claimed to justify deregulation of food and drugs. He approvingly reports that the drive largely, but not entirely, failed. Ultimately, however, Hilts' book makes it clear that while the agency has been led by both vigorous regulators and apologists for industry, its usefulness is ultimately defined by the powers that Congress grants it. Two pivotal moments of legislative history, both covered extensively in the book, demonstrate this point.

In early 1962, Sen. Estes Kefauver, a Tennessee populist, was near failure in a long legislative campaign to strengthen the FDA's authority to deal with the growing powers of the pharmaceutical industry. Since World War II, antibiotics, steroids, polio vaccine and other breakthroughs had revolutionized industry and medicine, but the FDA's procedures and authority had changed little since 1932. Although three years of hearings had exposed industry profiteering, unsavory marketing and an FDA that was often too cozy with industry, Kefauver had not gotten support from the Kennedy White House.

Then, suddenly, the public learned that powerful new drugs could harm as well as heal. Magazines and newspapers around the world published heart-rending pictures of horribly deformed babies, the result of pregnant women taking a new sedative called thalidomide. Although the consequences were largely avoided in the United States because the FDA delayed the drug's marketing until the manufacturer could provide more scientific data, the pictures quickly reversed the political tide. A tough law was quickly written and speedily passed.

Congress declared that a prescription drug could not be marketed unless the manufacturer could demonstrate with "substantial" scientific evidence that it was effective. (A law requiring evidence of safety was already on the books.) Furthermore, the law admitted a single proof of efficacy: controlled clinical trials. It was a revolutionary idea, especially the requirement for controlled clinical trials. For the first time, the law rejected testimonials from patients who swore that they had been miraculously cured, and it ignored the expert opinions of doctors who history instructs us are remarkably uncritical about the treatments they prescribe. Nor did it accept long traditions of use, whether for decades or for centuries.

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