Regulation for Dummies

Is the FDA necessary?

Todd Seavey from the April 2004 issue

(Page 2 of 2)

Hilts addresses some individual examples of FDA foot dragging, showing that the body count in each case has been exaggerated by the agency's critics. But he does not grapple with the larger theoretical argument that the FDA may cost more lives than it saves (though he does debunk some of the most commonly cited examples of blocked miracle treatments). In a lesser offense against economics, Hilts places the cost of FDA regulation at a mere $3 or $4 per citizen each year, an estimate that reflects only the agency's budget, not the immense regulatory costs it shifts onto companies by requiring them to do clinical trials, let alone the costs in terms of drugs delayed or blocked.

It is not merely the use of exotic, experimental new drugs that the FDA stymies. It also forbids companies to promote "off-label" uses of drugs -- that is, demonstrably beneficial, even life-saving, uses for which a drug was not originally intended and for which it has not yet been approved by the FDA. As journalist James Bovard notes on the ACSH Web site, a 1994 British Medical Journal article estimated that some 10,000 American lives could be saved each year if more people were aware that daily aspirin use can lower the risk of heart attack. "Yet the FDA has prohibited such notices," Bovard writes. "And since no company has a patent on aspirin, no company has the incentive to spend the tens of millions of dollars for clinical trials and other tests necessary to satisfy the agency."

While it is worth calculating the number of people who have died while awaiting the FDA's approval of new treatments, we cannot merely tote up those numbers and weigh them against the handful of people killed by thalidomide and other bad drugs. To be fair, we must instead ask, as Hilts implicitly does, what the pharmaceutical industry would look like in the absence of the scientific discipline the FDA has imposed. We cannot assume that only the beneficial medicines we now know would be marketed, or that the disasters would be limited to the ones we have already seen. In the ambiguous realms of science and marketing, even mostly well-meaning companies will tend to err on the side of puffery and concealment of blunders.

Many of the harshest economic criticisms of the FDA are built on economist Sam Peltzman's 1973 study that showed fewer new drugs created in recent decades than in the early-to-mid 20th century. But Peltzman's study did little to adjust for the countless redundant or little-improved medications that were touted as new miracle drugs in the old days. Nor did Peltzman adequately take into account the inevitably slowed pace of fundamental pharmaceutical breakthroughs. Hence the apparent lag in progress that Peltzman's simple graphs depicted does not tell the whole story.

Think of the FDA, when it functions properly, not merely as a hobbling bureaucracy but as anti-fraud law applied to food and medicine. The question is how to tease out the FDA's useful functions -- preventing fraud and injury -- while eliminating its more burdensome regulatory functions. Instead of prior approval of drugs, might we simply have harsh legal penalties and financial compensation of victims after the fact when things go awry? Perhaps the FDA could be replaced with private mechanisms, probably involving a much more active role for trial lawyers, a solution almost as unacceptable to free marketeers as regulatory agencies but at least a private and decentralized one. (What does private, decentralized retaliation against widespread fraud and injury look like if not a class action suit?) Or perhaps the FDA could be replaced by something akin to a supersized Underwriters Laboratories, the private product testing organization supported by manufacturers that want its famous "UL" stamp of approval.

Just as we cannot know exactly what the modern food and drug market would look like without FDA oversight -- neither what new horrors nor what currently stymied innovations it might bring -- we cannot know for sure what the FDA might have looked like had it evolved differently. Early on, its primary legal function, as Hilts explains, was to guarantee safety rather than to ensure efficacy. Its failure to do the former contributed, in typical government fashion, to the expansion of its power and the adoption of its sweeping powers of pre-market approval and its right to certify that drugs are effective -- a costly hurdle for drug manufacturers, whose research and development costs are nowadays largely a function of the need to please the FDA.

Might new opportunities for innovation be opened up simply by eliminating this guarantor-of-efficacy role? Let the FDA, some successor organization, or the civil justice system punish those who do harm or sell dangerous goods, but leave the market to judge what works and what doesn't.

That sounds like a freedom-respecting solution, but there is a complication: Just as the anti-fraud role of the FDA bled into the efficacy-proving role historically, the two functions can be difficult to separate in principle. A drug that is marketed as a memory enhancer or heart strengthener, with a tiny fig-leaf disclaimer saying its vaunted powers do not have the imprimatur of the FDA, can do significant harm without inflicting direct thalidomide-style damage by leading people to avoid more effective treatment or simply by causing them to spend their money in vain. Since few people deliberately spend their money on ineffective products, almost everyone who purchases a scientifically unproven medication, such as most of the alternative remedies, vitamins, and dietary supplements for sale in the average health store, is arguably being defrauded.

But is that a matter for a federal bureaucracy or simply for the courts? Where one comes down on that question will hinge in part on how savvy one thinks the general public is, relative to scientific experts (such as the ones who end up working for the FDA), about evaluating medical claims. To anyone acquainted with the general public's track record, the case for the bureaucracy looks surprisingly strong.

Such questions are beyond the scope of Hilts' book. His argument proceeds more on historical than theoretical grounds, and as a result he sometimes glosses over important ideas in a way that weakens his case. Despite devoting several chapters to the regulatory battles of the last few decades, he only briefly mentions the high-dose lab tests on rodents that are the main means of labeling substances "carcinogens" these days. The so-called Delaney Clause of the 1958 Food, Drug, and Cosmetic Act gave the FDA the absurd responsibility of eliminating any trace whatsoever of chemicals capable of causing cancer in lab animals. But roughly half the chemicals in the world, natural or man-made, can induce cancer in lab animals in high enough doses, and that is not in itself good evidence of a human health threat. To many scientists who criticize the FDA and the Environmental Protection Agency, the exaggerated claims made for rodent tests are a primary example of regulatory excess.

Yet Hilts touts the removal of numerous "carcinogens" from the food supply as unvarnished victories for the FDA. He uncritically repeats claims that the sweetener saccharin was a potential human carcinogen that deserved to be banned in the 1970s, although later research suggests that the biological mechanisms that made it carcinogenic in rodents are not present in humans. Hilts also at times makes the common journalistic error of telling us about deaths associated with a product without telling us the normal background rate of deaths of that sort, information we need to have some idea how much the product worsened things, if at all.

Still, the book presents enough compelling horror stories to convince even the skeptical reader that there have been menaces and mishaps out there for the FDA to fight. Among other things, Hilts discusses painkillers that destroy liver function; the soft-pedaling of scientists' warnings about severe side effects; the antibiotic chloramphenicol, which was only reluctantly and half-heartedly recalled by its manufacturer even after the company learned the drug caused a fatal blood disorder; and heart medications that quietly killed more people than they saved, even while the FDA was criticized for not approving them fast enough.

The FDA could be radically improved or even supplanted, but it would be wrong to think that the agency's inefficiency or its inherently coercive nature prove it is performing no useful functions or providing no useful scientific information. The FDA, for complex historical reasons, has become a locus of scientific standards and a repository of expertise that should not be discarded. It has helped shape the achievements of pharmaceutical companies and by extension mainstream medicine in a process of give and take as important as the shaping of business by laws against theft.

One sad conclusion you have to draw from Hilts' book is that if you sell almost anything as a cure-all, lots of people will fall for it. To get back to my opening question: Shouldn't the law step in on behalf of the stupid as readily as it would on behalf of a genius who is duped by a brilliant, elaborate scam? Before you say no, you will at least have to contend with the disturbing picture Hilts paints of the days before the FDA as we know it. There is no avoiding some sort of legal constraint on food and drug sales, unless we want a modern version of the 19th-century free-for-all that poured mislabeled opium and disguised wood chips down the gullets of the ignorant. That's not freedom. That's fraud.

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