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Wednesday, July 7, 2010

Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation

An Amply Documented but One-Sided History of the FDA

George Stigler once compared regulating on the basis of corporate misdeeds to an audition at which the second singer is selected after only the ?rst has sung. When it comes to food and health, Philip Hilts, a veteran medical reporter, runs the same sort of abbreviated audition. His latest book is an eminently readable, amply documented history of the U.S. Food and Drug Administration (FDA), from its origin nearly a century ago to its current status as regulator of nearly one quarter of American consumer expenditures. Unfortunately, it is also a frustratingly one-sided book.

Let’s start with something simple, like ketchup. Hilts’s ?rst regulatory hero is Dr. Harvey Wiley, a government chemist who in the early 1900s began campaigning for a ban on many food preservatives. Wiley came close to getting President Theodore Roosevelt’s backing for a prohibition on benzoate in ketchup, but failed. Hilts closes the chapter with Wiley supposedly being vindicated by history because some of the ?rms that originally opposed him eventually stopped using the chemical.

You won’t learn it from this book, but Wiley’s views of benzoate’s risks turned out to be wrong; even today, the chemical is widely used as a preservative. Banning benzoates in Wiley’s time might well have increased ptomaine poisonings. And ?nally (for you public-choice fans), it’s likely that the few ketchup companies that supported Wiley, such as Heinz, had more than the public interest at heart. Yes, they used better tomatoes and production methods, but they also charged more — Heinz cost over twice as much as regular ketchup. Wiley’s ban would have helped Heinz competitively, while punishing people who had better use for their money than high-priced ketchup.

Medicine is more complicated than ketchup, but Hilts’s simplistic approach doesn’t change here. In his world, corporate greed is to blame for all defective drugs, the FDA’s incentives are always bene?cial, and the few government mistakes he acknowledges could be cured by more funding. As for the lives lost due to FDA delays in approving new therapies, those are a ?gment of the New Right conspiracy to dismantle the agency.

For example, Hilts excuses the FDA’s three-year delay in approving Interleukin-2 for advanced kidney cancer because, he claims, the drug “was useful to only a small number of patients” and during the delay the agency provided “early availability for those who felt they needed to take the risk.” Now it’s true that Interleukin-2 produced temporary remissions for only 15–20 percent of those taking it, and that the drug itself was highly dangerous. But many patients preferred that to the 100 percent death rate of the disease itself. As for its alleged pre-approval availability, the head of the National Kidney Cancer Association had a one-word comment at the time, a word we won’t reproduce in this magazine.

Compare this to Hilts’s stirring account of how the FDA took only six weeks to approve the ?rst of the protease inhibitors for AIDS. The agency didn’t insist on data of reduced mortality because such information would have taken far more time to collect and demanding it was viewed as unethical given the life-and-death situation of AIDS patients. Instead, the agency approved the drug on the basis of preliminary data that showed improved cellular function.

AIDS patients were highly organized; kidney cancer patients were not. If they had been, they probably would have been treated better by the FDA. When access to new therapies is controlled by government, political clout may well determine who gets better service. But this issue doesn’t ?t into Hilts’s framework.

Corporate wrongdoing has certainly been a factor in such medical disasters as thalidomide and the Dalkon Shield, but regulatory delays in?ict at least as much damage. When the FDA approves a life-saving therapy, some number of people have to have died waiting for the agency to act. Hilts, however, refuses to even acknowledge this. He characterizes as “grotesque” the argument that the FDA’s focus on preventing bad drugs may lead it to delay or deny useful drugs. But this risk is clear. While defective drugs and drug delays both have adverse medical consequences, their political impacts are incredibly different. Drug recalls are the subject of news stories and congressional hearings. Drug delays, on the other hand, rarely get noticed; all that their victims know is that their doctors can’t do more for them. The skewed regulatory incentives that result were acknowledged by former FDA head David Kessler, another of Hilts’s heroes, who wrote that “speeding access to urgently needed products was not nearly so deeply ingrained in our culture.”

In its emphasis on drug recalls and its rationalizations for drug delays, Protecting America’s Health unintentionally demonstrates this very point. It’s unfortunate that, in a book of this scope, this issue gets a bum’s rush.

Sam Kazman is general counsel of the Competitive Enterprise Institute (, a Washington, D.C.-based free-market advocacy organization.