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by Scott Tips March 2001, Whole Foods Magazine |
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Remember the great Chilean grape scare of the 1980s? Supposedly the Food and Drug Administration (FDA) tested some Chilean grapes only to discover that they contained poisonous cyanide. The ensuing ban upon the importation of Chilean agricultural products devastated that unfortunate country's economy for several seasons. Forgotten, though, in the alarmist cries of the time was the simple fact that cyanide has a half life of just a few hours and the suspect grapes had been in FDA's possession for many times longer than that. So, the difficulty in answering the question of who might have injected the cyanide into the grapes is probably less than even that of any of the opening questions in the television series "Who Wants To Be A Millionaire?" Now, passing over the equally ill-conceived L-tryptophan ban, the politically-motivated ginseng ban during "Koreagate," and other such, shall we kindly say, misguided attempts to protect the public's health, we arrive at the current "bête noir," or "black beast," that has drawn the FDA's ire: aristolochic acid. Aristolochic acid is found in various herbs such as Aristolochia fangchi, Virginia snake root, and Indian birthwort. Those, and many other aristolochic-containing herbs, have been used for centuries, if not millennia, as healing agents. However, the New England Journal of Medicine has reported in its June 8, 2000, issue that Belgian doctors noted that more than one hundred patients suffered kidney damage after their use of weight-loss pills containing aristolochic acid. Some of these patients were also discovered to have urinary-tract cancer or precancerous abnormalities, all of which are serious and worthy of reporting. No one has questioned the fact that these patients have suffered these conditions. The only question, and remaining issue, is what caused these serious problems? Were they really due to aristolochic acid? According to Andrew Gaeddert, herbalist and author, the answer is most probably not. First of all, he says, all of these reported cases were associated with a single clinic in Belgium where the patients did not just receive an herbal weight-loss pill, as reported. All of the patients were taking a veritable "mishmash of unsafe drugs" that included appetite suppressants, stimulants, serotonin injections, and other concoctions. Secondly, and as an interesting counterpoint, none of the persons solely on the Chinese herbal mixture showed any signs of kidney failure. As for the two additional, reported cases of kidney failure in Great Britain, they are equally suspicious. While it is alleged that the kidney failures were caused by an herbal preparation containing aristolochic acid, I am informed that no proof has been shown that the failures actually resulted from aristolochic acid. One of the two persons had been on Chinese herbs for six years, while the other had been on Chinese herbs for an indeterminate number of years. Their pre-existing medical condition and intake of drugs is unknown and so it would be premature to assign the blame to aristolochic acid without having more information. In short, no proof of a cause-and-effect relationship between aristolochic acid and the kidney failure has truly been established. Nevertheless, on the basis of the Belgian, British, and other countries' reports, FDA issued an Import Alert (#54-10) on July 6, 2000, for the detention without physical examination of any products that may contain aristolochic acid. Then, during the Fall, the FDA convinced a few companies such as East Earth Herbs and Nature's Wonderland to conduct voluntary recalls of their herbal products containing aristolochic acid. And these days, where FDA actions and recalls blaze the trails, personal-injury lawsuits often follow. Yet, you have to wonder about the reason for this attack on aristolochic acid. Superficially, it does seem legitimate. On the other hand, looking beyond the surface, reasons abound to doubt its legitimacy. As mentioned above, the chain of cause and effect appears to be tenuous at best. Then consider that no adverse reports have ever been filed with FDA for dietary supplements based upon their aristolochic-acid content. Moreover, aristolochic acid was studied in the 1970s as an anticancer drug and apparently had no adverse effects upon humans, although the laboratory animals given extremely high doses of pure aristolochic acid (not found in any herbs, and certainly not at such high levels) did experience some adverse reactions, which proves nothing except that laboratory animals should avoid extremely high doses of pure aristolochic acid. There is even an argument that because the level of aristolochic acid in these suspect herbs is only 1 to 2 parts per million and because it is a substance naturally occurring in the herbs (such as oxalic acid in rhubarb), FDA regulations themselves prohibit the FDA from seeking to ban such herbs. Given our past experience with FDA bans and regulatory actions, and given the inherent tendency of government agencies to grow in power and size over time, perhaps the real reason behind the FDA's action here is nothing more than to whip up a poster boy for tighter regulation of the industry. Our old friend David Kessler, former head of the FDA and now the humble dean of the Yale School of Medicine, lends credence to this theory with his insipid editorial that accompanied the New England Journal of Medicine article on aristolochic acid. In it, Kessler argued that this case and others "should persuade Congress to change the law to ensure the safety and efficacy of dietary supplements before more people are harmed." Surely the FDA is popping champagne corks over this latest example of the dangers of "lax regulation" of dietary supplements. And imagine, if other dangerous problems should arise with dietary supplements (as surely they will so long as there is a goal to be achieved), then perchance Congress might be stampeded into abandoning the Dietary Supplement Health and Education Act of 1994, or at least straightjacketing it enough, to give FDA the increased powers and controls that it seeks. If there is one thing the federal government has learned over the years, it is the lesson that Americans, scared by "emergencies" either real or manufactured, can then be easily persuaded to abandon their freedoms for the "security" and "safety" offered by the government. Given FDA's past track record and the slick packaging of the New England Journal of Medicine article together with Kessler's siren call for more regulation of our industry, I smell a rat in the aristolochic-acid ban and recalls. Whether genuine, an FDA bungle, or an excuse for control, this latest emergency should be scrutinized carefully.
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