Regulation for Dummies

Is the FDA necessary?

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."

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