Pubdate: Tue, 11 Mar 2003 Source: Wall Street Journal (US) Copyright: 2003 Dow Jones & Company, Inc. Contact: http://www.wsj.com/ Details: http://www.mapinc.org/media/487 Author: Jerome Groopman HERBAL OVERDOSE The death of Baltimore Orioles pitcher Steve Bechler last month, while taking the weight-loss product ephedra, sparked a heated debate regarding the role of the federal government in regulating dietary supplements. In the wake of Bechler's death, Tommy Thompson, secretary of Health and Human Services, went so far as to say that he would never use ephedra himself or recommend it to family or friends. Now, the Food and Drug Administration has moved to impose new rules and regulations governing manufacturing practices and content labels for dietary supplements that include not only ephedra but other herbs like ginko biloba, used to boost cognition, and St. John's Wort, taken for depression. With millions of Americans consuming these supplements daily, it's a matter of "buyer beware," according to FDA Commissioner Mark McClellan. Unfortunately, a simple caveat emptor isn't good enough. The FDA has stopped short of putting these supplements in the category of pharmaceuticals and thus has failed to fulfill its charge to assure that the health products we consume are both safe and effective. In navigating the current controversy, we would do well to summon the history of the last century that led to the initial regulation of food and drugs , and draw on the equipoise of its most determined sponsor, President Theodore Roosevelt, who sought to sustain the initiative and competition inherent in capitalism while protecting the health and welfare of Americans. There are striking similarities between today's herbal and dietary supplement markets and the production and sale of food and drugs in the late 19th and early 20th centuries. Back then, there was scant government oversight into the quality of food preparation and the composition and manufacturing of medications. Moreover, the border between food and drugs was blurred. Many "natural elixirs" with putative healing powers were either completely ineffective or remarkably dangerous. A massive industry had grown in America around so called "patent" medicines. They were termed so because of their secret and proprietary components. Physicians at the time, of course, had little in their therapeutic armamentarium, lacking drugs like antibiotics that today we take for granted. If patent medicines had merely been harmless placebos, then the argument for their regulation would have been weakened to that of Dr. McClellan's caveat emptor. But concoctions like Lydia Pinkham's Vegetable Compound were potentially toxic elixirs laced with large amounts of alcohol and opium. Roosevelt was keenly interested in nature, and knew that she was not always a benevolent goddess. Many herbs and plants are poisonous, particularly when ingested in large amounts. They also serve as the sources of potent medications, like digitalis, which comes from foxglove. Roosevelt had also struggled with ill health as a child and young man, afflicted with debilitating asthma and a frail body. His solution to his medical problems was to pursue a robust life of good diet and ample exercise, in essence, exerting his considerable willpower to try to overcome his maladies and rebuild himself. It is, therefore, a fair assumption that Roosevelt would be particularly aghast at the proliferation of products that Americans are currently taking to substitute for willpower, like ephedra. And he would be similarly disappointed at the failure of federal regulators to forcefully intervene and require manufactures to provide detailed information to consumers about both the dangers and the degree of efficacy of their products. We can also posit Roosevelt's familiarity with the forces that may be inhibiting the Bush administration from taking the full and needed step to classify herbs and dietary supplements as medicines. Similar forces were arrayed against Roosevelt when he pursued the pure food and drug acts of 1902 and 1906. At the time, much of the nascent American advertising industry and the revenues of newspapers pivoted on the promotion of unregulated products like Lydia Pinkham's Vegetable Compound. Congress was persistently and potently lobbied by representatives of these industries to water down any proposed regulations. The lobbyists argued that for capitalism to flourish it could not be shackled by onerous federal intervention, and that Americans should be free to choose what they wanted to take for their health. Roosevelt believed deeply in the forward moving currents of competition and innovation in the flow of commerce. He also was a great believer in science, a polymath who wanted the facts in clear and concrete terms before making a considered judgment. Roosevelt, then, was a person not only of the head but of the heart. His "compassionate conservatism" meant protecting the vulnerable from the manipulation of the corrupt and promoting choice when that choice was rationally and fully informed. Nonetheless, the legislation that Roosevelt initiated, and the many amendments that have passed through the Congress over the last century, have proven imperfect in regulating the plethora of dietary and herbal products that flood our society. It is scandalous that only after the death of a young athlete would good manufacturing practices be mandated and bottle labels have to accurately note contents. Keep in mind that we are not talking about severe life-threatening diseases like cancer or AIDS, where excess FDA regulation could slow the development and distribution of key drugs . We are talking about herbal supplements like ephedra, which is considered "natural" yet contains a potent chemical that can mimic the effects of amphetamines, causing heart attack, stroke, and arrhythmia. Recently, both ginko and St. John's Wort were shown to be no better than placebo. Merely knowing what is in the bottle does not inform consumers of the scientific evidence supporting claims about the product or the risks they run in taking it. That would be true caveat emptor. Theodore Roosevelt has been said to serve as a model for President Bush in terms of bold action and moral clarity. Our president would do well to apply Roosevelt's appreciation for science and his pursuit of honest commerce in bringing to heel an industry that is out of control and a threat to the health of Americans. Dr. Groopman is a Harvard Medical School professor and chief of experimental medicine at Beth Israel Deaconess Medical Center in Boston. - --- MAP posted-by: Josh