Regulation for dummies.

We were very disappointed by Todd Seavey's review of Protecting America's Health ("Regulation for Dummies" April).

Since it's impossible to detail all of our disagreements in a short letter, we would like to focus on one particular point: The Food and Drug Administration (PDA) is causing far more harm to the health of Americans than it is preventing. It has cost the lives of more than 1 million Americans since 1994 by prohibiting the inclusion in labels and in labeling (literature that accompanies a product at the point of sale) that omega-3 fatty acids can reduce the risk of a sudden-death heart attack by 50 percent to 80 percent. At least 150,000 Americans each year were thus prevented from saving their lives with safe, inexpensive fish oil supplements. One million dead because of FDA censorship of truthful health information on one dietary supplement is a severe harm to the public health, far more than those killed by 19th-century patent medicines.

In 1994 the two of us filed suit against the FDA for violating the First Amendment by prohibiting the inclusion of truthful information concerning four health claims. In 1999 a federal appeals court ruled in our favor, and the FDA declined to appeal to the Supreme Court. Thus this decision, Pearson v. Shalala, is the law of the land. Yet for the next two years (until we sued and won again), the FDA continued to prohibit the inclusion of truthful information on the heart- and life-protecting effects of omega-3 fatty acids. In 2001, seven years after our initial suit was filed, the FDA agreed to allow a "qualified" health claim.

The purported 19th-century "free for all" is usually the fallback position of those who approve of FDA controls on foods, dietary supplements, medical devices, and drugs. It is the unrecognized costs, however, such as the FDA'S unconstitutional prohibition of truthful information on foods and dietary supplements, that reveal an FDA that does far more harm than good.

Our recommendation is that the FDA be transformed into a certifying agency, so that it can use its standards to certify products for safety and effectiveness, while uncertified products could be marketed with a large-type disclosure that "this product is not FDA-certified" or whatever other warning might be needed.

Durk Pearson and Sandy Shaw 

via fax

Todd Seavey replies: Even today, the heart benefits of omega-3 fatty acids are not certain, although the results of three recent studies were promising. (Two of them were hampered, unfortunately, by relying on questionnaires rather than precise measures offish oil intake.) Talking about omega-3 benefits as if they are certain--and were certain as soon as the first studies came out--is exactly the sort of hasty touting of new studies that drives the largely unscientific dietary supplement industry, including many popular but useless potions for longevity and memory enhancement.

To make a full calculation of the effects that eliminating the FDA would have, we would need to imagine not simply a world in which accurate information reached people more quickly but a world in which products and claims based on every preliminary study and dubious, apparent benefit were rushed to market. That world would not look exactly like the 19th century, but it would look all too much like today's health food stores, expanded to displace the more boring but better-tested products of mainstream medicine and agriculture. In such a world more people would be lured away from proper medical treatment to die while hoping for a miraculous tree bark cure for their cancer. I'm all for free speech and the free market, but we must acknowledge that false hope sells and find some way to combat that problem.