Nearly ten years ago, David A. Kessler, M.D., Commissioner of the U.S. Food and Drug Administration (FDA), proposed a moratorium on the use of silicone-gel devices for breast augmentation. This initiative contravened what Kessler's scientific experts, and an advisory panel composed of FDA designees, had recommended. Kessler subsequently dispatched U.S. marshals to a Minneapolis, Minnesota, storehouse, where they seized 55 cartons of breast implants. The FDA tipped off the media concerning this mission; so television cameras were in position before the marshals arrived.

The basis for this interdiction wasn't clear. The product had sold since 1966. No indictments ensued in conjunction with its prohibition, and no infraction of any governmental regulation concerning the product was ever established. Nevertheless, its manufacturer—the FDA having made the company and silicone-gel breast implants objects of nationwide adverse publicity—shortly filed for bankruptcy.

The FDA's aggressiveness on the issue seemed to astound plastic surgeons. Physicians had effectively used implantable silicone devices, of more than 350 types, for 40 years. Probably few surgeons were aware of the historical precedents for regulatory agencies' acting according to political aims instead of according to available scientific evidence.

Should We Drop Soda Pop?

Almost a century ago, former U.S. Department of Agriculture chemist Dr. Harvey Washington Wiley, as the first director of the FDA, sent U.S. marshals to a Tennessee railroad station, where they seized Coca-Cola syrup that had been in transit from Atlanta to Chattanoo-ga. The 1911 trial that followed on this was referred to in court records as "United States vs. Forty Barrels and Twenty Kegs of Coca-Cola." The decision on which its conclusion hinged concerned whether or not the beverage producer had knowingly poisoned consumers. The purported toxicant was not cocaine, whose extraction from the soft drink's coca-leaf ingredient had been routine for many years. It was caffeine. That both coffee and tea contained much more caffeine than Coca-Cola had ever contained was not an important consideration for Wiley in his pursuit of food purity. Like Kessler, Wiley strategically attracted publicity to his pursuit. He even brought his bride to Chattanooga on the pretext of a honeymoon.

Numerous experts on both sides of the issue were called to testify, the defense prevailed, and the FDA backed down—temporarily. Efforts to cast public doubt on the safety of Coca-Cola persisted for several more decades. In 1964, consumerist Ralph Ginzberg, the Ralph Nader of his day, spoke of "a massive dossier of medical evidence indicting Coca-Cola as one of the most poisonous beverages ever found in a bottle that doesn't bear a skull and crossbones!"

Just as Coca-Cola, not caffeine, was the focus of the FDA's action in 1909, the implantable silicone-gel device, not its silicone polymer, was Dr. Kessler's target in 1992. Ample investigation had shown that silicone is relatively inert in biologic tissues, and in then recent immunotoxicology studies funded by another government agency, scientists had found that silicone was unlikely to induce an immune response. In its implied quest for an adverse immunogenic consequence of implanting silicone-gel devices in breasts, the FDA under Kessler apparently disregarded the conclusions from those studies. Furthermore, the agency seemed as oblivious to the question "Why haven't the many non-breast-related silicone devices proved injurious during the 40 years of the use of such devices?" as it had been to the fact that coffee and tea each made for far more exposure to caffeine than did Coca-Cola.

Folly Marches On

The expression "junk science" has often been used to highlight false premises that can become the bases of wasteful public policies. Perhaps no English word summarizes the essence of junk science better than "folly," which usually refers to:

• a lack of good sense, understanding, or foresight;
• foolery, especially rash or extraordinarily or tragically foolish actions;
• a foolish, unwise, unprofitable or excessively costly undertaking, especially one whose effects are absurd or adverse; or
• a foolish belief.

In The March of Folly: From Troy to Vietnam (first published in 1984), the distinguished historian Barbara W. Tuchman (1912-1989) attributed history's salient instances of misgovernment to tyranny, ambition, incompetence, and folly. Although misregulation by government agencies can result from tyranny, ambition, and/or incompetence, more often its source is folly. According to Ms. Tuchman, part of what makes a governmental policy a folly is the coexistence of that policy and recognizability of a policy likely to be more productive. On this basis, wherever science and politics intersect, folly is reasonably definable as a belief or policy founded on unscientific, meager, or sham evidence when ample sound evidence exists that justifies a rival, especially a contrary, belief or policy.

Soda-pop caffeine and breast-implant silicone were among an expansive medley of substances branded in the 20th century as toxic by agitators who seemed to delight in sounding off on hypothetical risks. It seems that however comprehensive biological understanding may become, there inevitably will be vehement proponents of unfounded biological beliefs.

More than two dozen studies on implantable silicone-gel devices have been completed since Kessler's FDA called for a moratorium on their use as breast augmenters. Virtually all of these studies supported the findings from all of the relevant studies completed before the FDA's mandate—that is to say, there is no reasonable evidence of a causal relationship between silicone exposure and any systemic disease. But since that 1992 mandate, attorneys have referred to more than 200 symptoms of illness as consequences of the mammary implantation of silicone-gel devices.

The cost of this folly is incalculable—and not yet estimable, for its aftereffects are ongoing. Billions of dollars have changed hands, a great portion of it to fight or prevent lawsuits. The FDA has unjustifiably frightened hundreds of thousands of patients. And much of the development of silicone products—which historically have been American commercial innovations—has moved to Europe.

No one, of course, should marvel at misgovernment's occasionally stemming from folly. It is more difficult to understand that there are individuals with proper training who are willing to do the equivalent of standing up in a crowded theater and shouting, baselessly, "Cancer epidemic!"

ACSH scientific advisor Jack C. Fisher, M.D., is a Professor of Surgery in the Division of Plastic Surgery at the University of California, San Diego.