Regulation

Regulation for Dummies

Is the FDA necessary?

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Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation, by Philip J. Hilts, New York: Alfred A. Knopf, 397 pages, $26.95

Should the law be fashioned for stupid people?

That's not a question Protecting America's Health asks explicitly—and the author, New York Times science writer Philip J. Hilts, no doubt would object to characterizing millions of American consumers as stupid. But it is a question that must be mulled by free market advocates, against whom Hilts explicitly directs his polemic in defense of the U.S. Food and Drug Administration and the regulations it issues.

It is tempting for free market advocates to say that the FDA could be eliminated outright—replaced by nothing at all—so that customers could work out for themselves, or with the help of advice columns and ratings services, which products were dangerous or ineffective. A few idiots might opt for deadly medicine or adulterated food on the rare occasions when businesses were shortsighted enough to sell such things, but that possibility should not stand in the way of experimentation by the rest of us. Or so the argument goes.

In contrast to this position—which we might sum up as "Buyer beware, bonehead!"—Hilts makes the case that whether it seems like wise business practice or not, completely unregulated food and drug companies will tend, if history is any guide, to get away with any corner cutting and exaggeration they can and even the occasional negligent homicide. No one sets out to kill the customer, of course, but there is a powerful temptation to downplay the likelihood that your product will kill people once you've invested a fortune in putting it on the market, especially if it takes close attention to statistics to notice the deaths.

If it is only uninformed morons who are at risk in a laissez-faire environment, one must conclude that there were an awful lot of morons in the 19th century (and that we may not be that much wiser today). As Hilts describes it, the late 19th and early 20th centuries were a time when the newfound ease of production, transportation, and advertising made it possible to deceive masses of anonymous consumers who would not long have tolerated such lies from their relatives and neighbors. "In chocolate, chemists found ground-up soap, beans, and peas," he writes. "To flour was added chalk, clay, or plaster of paris…In examining brown sugar, researchers often found that a substantial portion of it was the carcasses of lice, together with some living ones."

Hilts calls the period "the grand era of the quack remedy" and describes the highly profitable sale of patent medicines that did nothing at all—or, in some cases, did serious harm—with their ingredients kept secret from both doctors and patients. Fines for mislabeling were small. In 1906 the maker of a lethal potion touted as a headache cure, called Cuforhedake Brane-Fude, was one of the first to be prosecuted under new laws requiring honest labeling of foods and drugs. After making about $2 million on the product, killing scores of customers, and being fined $700, the maker of Brane-Fude was, in the words of the chief of the government's Bureau of Chemistry, "just $1,999,300 ahead." Advertising of that day routinely described opiates and colored water as elixirs capable of curing cancer, syphilis, arthritis, and other ailments.

As if subconsciously influenced by the muckraking journalists of that era, Hilts rails against the greed of the trusts and combinations that foisted their shoddy wares on a duped populace. One almost expects to find plutocrats and fat cats in the index. Hilts describes the Progressive attitudes of Teddy Roosevelt with approval and fawningly portrays modern-day anti-corporate activists such as Ralph Nader and Sidney Wolfe as "people who work to solve public problems with fact-gathering and no motive of personal gain." But even if you dismiss Hilts' politics, you're left with the historical facts he describes and the question of how to keep such things from happening again.

By the mid-20th century, the Bureau of Chemistry had grown into the FDA, and residual industry objections to regulation were becoming the stuff of parody. Hilts quotes a sarcastic article from a New Deal-era issue of The Nation saying that food and drug laws challenge "the sacred right of freeborn Americans to advertise and sell horse liniment as a remedy for tuberculosis…his God-given right to advertise and sell extract of horsetail weed as a cure for diabetes."

In the 1940s and '50s, there gradually developed the modern two-step performed by the FDA and drug companies, in which the companies must gear their production processes from the very beginning to the eventual necessity of proving their products' efficacy and safety to the FDA. One interesting lesson of Protecting America's Health is that, rather than being merely a bureaucratic imposition on scientific progress, the FDA was arguably the co-inventor of the clinical trial process, which involves statistically comparing a large group of patients who are given a new treatment to a control group of patients who are not. This is the process on which modern medicine founds most of its claims.

It is not unreasonable to argue that companies making scientific claims ought to have scientific evidence to back them up, and clinical trials are the best means we have yet devised for getting that evidence. It is no coincidence that many of the FDA's harshest critics—aside from those who object to regulation on principle—are adherents of "alternative" medical methods that would never withstand the scrutiny of carefully constructed clinical trials, such as most herbal remedies and virtually all "homeopathic" ones. Many of the alternative medicine adherents argue against the very idea of clinical trials, saying that biology varies so much from individual to individual that no meaningful conclusions can be drawn about a remedy from impersonal trials on large numbers of people.

Even if we were to conclude that clinical trials are grievously flawed, though, it is unclear why we should embrace mere anecdote or the word of the local Chinese herbalist—heavily influenced by subjective impressions, placebo effects, and poor number crunching—as a superior guide to truth. Hilts is particularly critical of the 1994 law that enabled makers of vitamins and herbal supplements to do an end run around the FDA by claiming their products are mere food, not medicine, despite the fact that their products' labels are replete with health claims and their sales presumably are largely a function of consumers' belief in these claims.

Mainstream pharmaceutical companies, by contrast, today are largely the product of a weeding process that resulted from the FDA's mid-century imposition of scientific standards and clinical trials. Far from burdening countless useful products in order to stop only one or two disastrously harmful drugs, the mid-century culling of drugs that were based on groundless, unscientific claims caused most drugs of that time to be discarded as useless or redundant. As Hilts says, changes in that period "weeded out the brutal, the stupid, and the needless." Although not as dangerous or as preposterously promoted as the patent remedies of the 19th century, the drug business of a half-century ago still contained much that was ineffective or of dubious value. To the extent that the FDA has helped winnow the mainstream drug market down to scientifically proven treatments, it has been a help rather than hindrance.

Unfortunately, the FDA does not always function properly, and Hilts has little interest in dwelling on the negatives. Biotech has faced particularly unreasonable FDA hurdles in recent years. Henry I. Miller, a former FDA official who is now a director of the anti-junk science group I work for, the American Council on Science and Health (ACSH), notes in an article on ACSH's Web site that the FDA's approval process seems to be getting slower, despite laws intended to streamline it. "In the early '80s," he writes, "FDA review of human insulin and human growth hormone had lasted only months—five and eleven, respectively," but "FDA officials reviewed the application for [biotech firm] Calgene's long-shelf-life tomato for two years before completing the process."

Worse, Miller notes, the FDA routinely denies approval to successful products already used in Europe, holding up use in the U.S. of items ranging from injectable antibiotics for resistant pathogens to a vaccine against meningitis. Economists calculate that the number of people who have died or suffered while waiting for useful drugs to be approved by the FDA may outnumber those saved by keeping bad drugs off the market. In a 2000 review of economists' reports on the FDA, Santa Clara University economist Daniel B. Klein reported that he was unable to find a single one who felt the agency approved drugs quickly enough. He found economists' opinions on what to do with the FDA "ranging in degrees from gradual decontrol to outright abolition of the agency."

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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