FDA Watch: To Tell the Truth

Critics of the Food and Drug Administration have long noted that people die while awaiting government approval for medicine that might save their lives. In recent years AIDS activists in particular have insisted that the FDA take this cost into account when reviewing a drug for safety and efficacy. But another FDA policy that results in many deaths—censorship of information about legal products—is less widely recognized.

The FDA prohibits unapproved health claims about the products it regulates, including foods, nutrients, prescription drugs, over-the-counter drugs, and medical devices. Instead of disseminating important health information, the agency actively suppresses it, causing hundreds of thousands of premature deaths every year.

For example, more than a dozen clinical trials since the late '40s have shown that low-dose aspirin can significantly reduce the risk of heart attack. The most definitive evidence comes from the government-funded Physicians' Health Study, conducted by scientists at Harvard University. More than 22,000 physicians took either low-dose aspirin (one tablet every other day) or a placebo over a period of about five years. In 1989 the researchers reported that the incidence of first heart attacks among men over 50 was 44 percent lower in the aspirin group than in the control group. The study, originally planned for 10 years, was cut short by its overseeing committee, which deemed it unethical not to give subjects in the control group the opportunity to take aspirin.

These results are widely accepted among doctors and scientists. Even so, the FDA has specifically prohibited aspirin companies from mentioning this study in their advertising because prevention of first heart attacks is not an FDA-approved claim. Yet no pharmaceutical company is going to undergo the huge expense of obtaining FDA approval for a health claim about an unpatentable substance (aspirin was introduced in 1899).

Each year in the United States, some 500,000 people die of heart attacks. About 40 percent of those deaths are sudden and unexpected; those people do not know they have cardiovascular disease. Surveys indicate that most people at risk of heart attack, especially those not under the regular care of a physician, are not taking preventive aspirin.

Similarly, the FDA does not permit a health claim on foods or nutrient supplements that "folic acid can reduce the risk of neural-tube defects, such as spina bifida." Yet this is a widely held scientific view. In September the U.S. Public Health Service (the agency that oversees the FDA) began to recommend that all women of childbearing age take 400 micrograms of folic acid daily, about twice what most American women get in their diets (mostly from green vegetables). Godfrey Oakley, head of the division on birth defects and developmental disabilities at the U.S. Centers for Disease Control, says of folic-acid protection: "You work all your professional career for something like this." The British National Health Service has been recommending folic acid to women of childbearing age for a few years and even supplies them with the nutrient.

Neural-tube defects are the number-one reason for induced abortions in women who want to have children. Some 2,500 babies are bom every year in the United States with such defects, and unknown thousands of others are aborted. Yet the FDA seizes as "mislabeled" any folic-acid supplements bearing the claim that the nutrient can help prevent this problem.

In defense of the agency's position following the Public Health Service announcement, FDA Commissioner David Kessler noted that folic acid can mask the symptoms of a vitamin B-12 deficiency, which if untreated can lead to serious consequences. But folic acid itself has low toxicity, and the possible anemia problem can be avoided by adding small and safe amounts of vitamin B-12 to any folic-acid supplement or folic-acid-fortified food. (This will eliminate the possibility of pernicious anemia in all except a small fraction of individuals, mostly elderly, who do not have enough "intrinsic factor" in their gastrointestinal tracts to absorb vitamin B-12.)

The FDA also censors claims based on the extensive scientific evidence that certain nutrients—most notably, the antioxidant nutrients C, E, and beta carotene—help prevent disease, including cardiovascular problems and cancer. For example, a recently published epidemiological study by UCLA scientists looked at 11,000 subjects over a 10-year period. The men who got about 800 milligrams of vitamin C a day (mostly from supplements) lived six years longer, on average, than men who received only the "recommended daily allowance" of vitamin C from food. (The RDA of vitamin C, set at the level that prevents scurvy in most people, is 60 mg.) Mortality among the men getting 800 mg of vitamin C a day was 30 percent lower than among men getting 50 mg or so in their diets. The women who got the high dose of vitamin C lived a year longer, on average, than those who received average amounts of vitamin C.

These lifespan increases were largely due to reductions in mortality from cardiovascular disease. The researchers concluded: "The inverse relation of total mortality to vitamin C intake is stronger and more consistent in this population than the relation of total mortality to serum cholesterol and dietary fat intake, two variables on which strong public health guidelines have been issued over the years." The study was published in the May 1992 issue of Epidemiology, a highly respected, peer-reviewed scientific journal.

Despite this and many other vitamin C studies demonstrating health benefits from amounts higher than the RDA, the FDA permits no health claims for vitamin C other than prevention of scurvy. Indeed, with few exceptions, the agency considers any health claims for nutrients to be mislabeling, justifying seizure of the product.

The FDA is thus obstructing a major means of controlling health-care costs: reducing the incidence of costly medical conditions, especially cardiovascular disease and cancer, through the use of preventive measures such as taking low-dose aspirin or antioxidant vitamins.

Fortunately, the FDA's control of information about health products is not as strong as it once was. Biomedical information is becoming widely available to the public through a variety of sources, including better press coverage of health issues and direct access to scientific journals and data bases. Although Kessler wants the FDA to be the "sole authority on health and nutrition information," the agency can no longer act as if it has a monopoly on the truth. The FDA is dealing with a public that is much better informed than ever before, and its claims of exclusive information or expertise are no longer credible.

If the FDA wants to regain its credibility, it should provide information rather than restricting it. One way to do this is a split-label system, which we first suggested in 1982. Under this proposal, the government would permit truthful health claims about FDA-regulated products, but manufacturers making a claim not approved by the FDA would have to include a prominent statement to that effect on their labels. The product could bear an easily recognizable symbol, such as the letters FDA in a circle with a slash through it, to alert consumers. The manufacturer would provide equal space on its label or literature for the FDA to say whatever it wishes. Both the manufacturer and the FDA could cite research (which nutrient companies are not permitted to do now) and any other information they deemed appropriate.

Consumers who wanted to make health choices based entirely on the FDA's advice would be free to do so; in fact, through the split-label approach, the FDA's advice on nutrients, right or wrong, would reach far more people than it does now. Consumers would thereby be warned that they, not the government, are responsible for choosing information sources and making their own decisions. The FDA would not be able to get away with providing false, misleading, and sometimes harmful advice that is out of touch with scientific findings.

Restrictions on advertising should also be lifted. The Federal Trade Commission is legally empowered to regulate advertising claims, while the FDA has legal authority to regulate only label content. But under the "extension of labeling" doctrine, the FDA deems any advertising literature, even (under some circumstances) books written by authors with no connection to the regulated product, to be a part of the label and thus within the agency's purview. The FDA therefore regulates advertising by the food, nutrient, drug, and medical-device industries.

The FTC has a fairly good record of allowing claims when consumers have reasonable ability to judge the results (for example, a claim that a product grows hair on bald heads), where the product appears to be reasonably safe in the intended usage, and where the product has a money-back guarantee. The FDA, in contrast, has a poor record of allowing truthful health claims, and the agency's approval, if you can get it, is generally extremely expensive, thus increasing the costs of health-enhancing products. We propose that the "extension of labeling" doctrine be renounced, leaving the FTC to regulate health claims in advertising.

Companies accused of making fraudulent claims should be allowed to defend themselves before a jury in federal court, where they would have the right to be represented by an attorney, to call witnesses, and to cross-examine government witnesses. Under the current administrative process, those accused of false health claims appear in an FDA "court," where the agency is judge, jury, and executioner. Defenders of the current policy might argue that using the federal courts to regulate fraudulent health claims is slow and expensive. But as we have seen, the current system, which allows the FDA to ban health claims by decree, entails far greater costs, in terms of both money and preventable disability and death.

Far from moving toward more openness, the FDA has announced its intention to ban or regulate out of existence most nutrient supplements and herb formulations. Fortunately, members of Congress have responded to this threat. Last year Sen. Orrin Hatch (R–Utah) introduced the Health Freedom Act of 1992, and Rep. Elton Gallegly (R–Calif.) introduced a similar measure in the House. These bills would prohibit the FDA from arbitrarily regulating or banning the sale of nutrient supplements. The Hatch bill would also allow health claims for which there is significant scientific evidence (not necessarily a scientific consensus as defined by the FDA) and would permit nutrient-supplement companies to challenge the FDA's ban of a health claim in federal court.

Congress should heed the warning of Nobel laureate Milton Friedman: "The FDA has already done enormous harm to the health of the American public by greatly increasing the costs of pharmaceutical research, thereby reducing the supply of new and effective drugs, and by delaying the approval of such drugs as survive the tortuous FDA process. Any increase in the FDA's authority over anything is a clear and present danger to the nation's health."

Durk Pearson and Sandy Shaw are the authors of Life Extension: A Practical, Scientific Approach (Warner) and Freedom of Informed Choice (Common Sense Press).