Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
By Philip J. Hilts, Alfred A. Knopf, 352 pages, $26.95
In the 1990s, attorney Daniel Troy made a name for himself defending pharmaceutical manufacturers and tobacco companies in their frequent fights with the Food and Drug Administration. But in 2001, Troy got an opportunity to champion the interests of those same clients from a far more advantageous position -- inside the FDA itself -- when President Bush appointed him to be the agency's chief counsel.
The results have not been pretty. A recent story in U.S. News and World Report, for example, fingers Troy as one of the people responsible for stalling FDA investigations of ephedra, the dietary supplement now blamed for 100 deaths, including that of a Baltimore Orioles pitcher. When Troy was a private attorney, he had lobbied the FDA to ease restrictions on advertising for prescription drugs. Once Troy joined the FDA himself, he ordered that all decisions to take action against false prescription advertising go through his office -- after which the enforcement actions mysteriously dropped by two-thirds. He also got to work revising the agency's regulations to allow drugmakers to promote drugs for uses not yet supported by clinical research.
Stories such as these are not exactly unusual today. Since taking office, President Bush has rewritten Clinton-era regulations on everything from medical privacy to power-plant emissions, subjected new regulatory proposals to cost-benefit analyses skewed in favor of industry, and put federal agencies in the hands of people who either philosophically oppose regulation or have financial ties to the industries they are supposed to regulate. But while the more egregious of these capitulations make the front pages, most escape scrutiny because they are too complicated or obscure. Deregulation may be no less essential to the ongoing right-wing assault on government than tax cuts or privatizing Social Security, but it rarely makes for sexy copy.
That is why Philip J. Hilts' new book is such an important and impressive work. Protecting America's Health is a history of the FDA from its origins as a tiny office within the Department of Agriculture in the 19th century to the battles over tobacco and AIDS during the 1990s. A lesser writer might have produced a dreary tome on such a topic. But Hilts, a veteran New York Times science and health writer, brings his story to life by populating it with characters worth rooting for -- and, in some cases, against. There's Harvey Wiley, the earnest scientist who prevailed upon Theodore Roosevelt to pass the nation's first food-safety laws. There's George Larrick, the 1950s FDA director appointed at the behest of the drug industry, whose unwillingness to order a quick withdrawal of thalidomide from the market nearly led to thousands of deaths in the United States (as it had in Europe). And then there's David Kessler, the controversial 1990s director whose pugnacious pursuit of the tobacco industry led his onetime Republican sponsors to brand him a "backstabbing" traitor.
If Hilts had done nothing more than describe these characters and how they shepherded the FDA through its various historical stages, the book would have been a worthy project. But Hilts has a larger agenda: He wants to defend the FDA from its critics by reminding readers why makers of foods and drugs need regulating in the first place. Hilts documents repeatedly how unsavory manufacturers have deceived consumers and exposed them to severe health risks -- as in the 1980s, when aspirin makers tried to suppress evidence linking their product to Reye's Syndrome.
Unfortunately, there's another recurring theme in Hilts' history: the political obstacles to making the FDA an effective sentinel. The FDA has grown in fits and starts because only in an extraordinarily hospitable political environment -- such as the Progressive Era or the New Deal -- have reformers been able to overcome the lobbying muscle of private industry. And even in those times, Hilts shows, it has taken at least one well-publicized crisis to provoke action. Shortly after taking office in the early 1930s, for example, Franklin Roosevelt supported a law requiring drugmakers to prove that their products were safe before selling them. But despite the president's popularity and the air of crisis lent by the Great Depression, the bill languished for years at the behest of industry-friendly legislators. Only the Democratic sweep of the 1936 elections and the death of 107 people, most of them children, who took an untested liquid antibiotic finally shook loose the legislation, propelling the FDA into the modern era.
Alas, as surely as each public-health crisis has brought new calls for reform, so each new reform has provoked a backlash. With depressing regularity, Hilts shows, conservatives have attacked the FDA by watering down its legal authority, cutting its staff or appointing industry hacks to run it. Ronald Reagan, for example, put a former industry consultant in charge of the agency, slashed its enforcement budget and stopped its lawyers from pursuing investigations. The new director canceled a "new program to give patients information about the drugs they were taking" and "curtailed the FDA's efforts to require labels on processed foods."
Conservatives will complain that Hilts gives their side of the story short shrift. And in fairness, the reported passages of the book focus almost exclusively on reformers and their allies, leaving readers with only a caricature of FDA critics -- some of whom, surely, have had good intentions. But Hilts faithfully recites the critics' most powerful argument against the FDA -- that it takes too long to approve new drugs -- and then demolishes it. While acknowledging that the FDA has had its lapses, Hilts notes that reforms to accelerate FDA approvals in the last two decades mean the United States now approves new drugs as quickly as other leading industrial nations. And in a chapter on the most infamous case of purported FDA delays -- the early stages of the AIDS crisis -- Hilts shows that even activists came to realize the inherent advantages of a modestly paced, deliberative process. Speeding AZT and other treatments onto the market eventually meant that many AIDS victims got the drugs at toxic levels, causing painful side effects and leading some patients to refuse treatment altogether. While the FDA became willing in some cases to accept "something less than certainty," Hilts concludes, "activists learned to respect the importance of sound data produced by scientists and regulators, even if it seemed slow to emerge."
If there's one argument likely to win over conservatives sympathetic to business, though, it may be Hilts' claim that effective regulation, far from stifling innovation, has actually accelerated it. It is no coincidence, Hilts rightly notes, that the modern pharmaceutical industry came into being during the 1940s and 1950s -- right after FDR signed the law requiring drugmakers to test all of their products for safety first. That requirement forced the pharmaceutical companies to invest heavily in research, which in turn sparked the discovery and development of all sorts of new drugs. As Hilts writes, "The regulations and the government shepherding of the drug business did what the free market failed for at least sixty years to do -- it weeded out the brutal, the stupid, and the needless that prevented the pharmaceutical industry from becoming a great engine of discovery and sales."
The same could be said of other regulations now under assault in Washington. The stricter fuel-economy standards President Bush opposes may ultimately strengthen the domestic car industry by sparking more innovative automobile designs. Sound medical-privacy standards may create jobs in the information-technology sector while reducing health-insurance premiums for everyone by permitting the creation of a massive national health database that would reduce medical errors and red tape. But Hilts makes clear that for him the best argument for regulation is the one that led Theodore Roosevelt and other Progressives to draw up the nation's first food and drug laws: It's the government job "to protect citizens from some kinds of commerce rather than just to protect commerce." That argument has fallen out of fashion. Here's hoping Philip Hilts restores some of its appeal.
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