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November 13, 1997

Sleeping with the Enemy

The old cliché about politics and strange bedfellows has never been demonstrated more vividly than during our present progress toward the Brave New Economic Order. A case in point is the shenanigans that preceded Congress's passage of the FDA reform bill on November 9. The main thrust of the bill is to create a safe and streamlined system for approving new drugs and medical devices, but a section calling for the United States to "harmonize" its regulations with those of other countries set telephones jangling and fax machines groaning from overwork.

At the core of the clamor was a fear that vitamins and other dietary supplements would be included in the harmony. Enter the villain, in the shape of the United Nations / World Health Organization Codex Alimentarius Commission, described by one of its opponents as "the greatest threat to health freedom in the world today."

The Codex was founded in 1962 to work out a set of standards for food hygiene and technology among its member nations. Early on, Germany began to play a leading role. Guided by Bayer and other powerful pharmaceutical companies, the country was analyzing traditional medical treatments (such as vitamin C and St. John's wort), incorporating them into its national health program, and limiting their non-prescription distribution. Using its own regulations as a model, it pushed for international codes to control the dosages that could be purchased on the open market.

In recent years Americans have been treated to a seemingly endless series of reports detailing the preventive and curative qualities of vitamins and other food supplements. Those old wives actually knew something after all! In a nation where medical care is increasingly costly and many people lack health insurance, the possibility of --- for example --- strengthening one's immune system by taking a relatively inexpensive bunch of antioxidants was viewed as a godsend. And it was a way that people could take responsibility for their own well-being, without having to consult a professional.

Then along came the reform bill. Despite reassurances from the FDA, panic reigned. One message circulating on the Internet shrilled, "We have only a very short period of time to protect our freedom to buy vitamins and other supplements....It is NO JOKE. We are about to lose our hard won health freedoms RIGHT NOW." Intellectuals proud of their well-informed nutrition programs found themselves fighting side by side with long-time foes of the FDA. The most vocal was the Life Extension Foundation, the target of a notorious raid by the feds in 1987 that confiscated the organization's records and stock of supplements. After the foundation devoted ten years to vigorous litigation, the courts dropped all charges.

Here the political bed gets crowded. The FDA has tangled nastily during the past several decades with a number of groups advocating alternative medical practices. A whole regiment of natural therapy clinics and health food stores nurse wounds from these encounters. The agency stands high on the list of "those who oppose Scientology." It even went head to head with the venerable Rodale Organic Farming and Gardening magazine. Many of these organizations regard the agency as the handmaiden of the AMA and American pharmaceutical companies and would be delighted to see it suffer a defeat. But the accusations of dangerous meddling go farther: a publication of Wilhelm Reich's Orgone Biophysical Research Laboratory manages to link the methods employed by the FDA to the government attacks on the Branch Dravidians at Waco and the killing in Idaho of white supremacist Randy Weaver's wife.

The harmonization proposal incurred other suspicions as well. The bill was seen as an open invitation to the United Nations, through the offices of the Codex, to intervene in American affairs. As a result, the willing point man in Congress was Texas Democrat Ron Paul, a pro-life obstetrician and the Libertarian Party candidate for president in 1988, who has worked tirelessly for our withdrawal from the UN.

Lo and behold, the orchestrated hysteria paid off. The Congressional conference committee produced a reconciled reform bill that was rushed to both houses for a vote (on a Sunday, of all days), with assurances that the final version was "all right." A few members objected to voting on a complex measure --- it covers some 177 pages --- before it was available for them to read. Nevertheless, they passed it overwhelmingly. When the dust settled, the vitamin folk discovered that they had won at least a minor victory: the bill calls for international discussions to "harmonize regulatory requirements" but specifically exempts dietary supplements.

It turns out, though, that still more fellows are tucked into this particular bed. American drug companies may be equally unhappy about the prospect of being fitted into a European mold, a situation that would constrict their own expansion. In a press release issued last August, the California-based pharmaceutical firm PharmaPrint announced that it had just filed an Investigational New Drug application with the FDA to conduct clinical trials using its standardized derivation from saw palmetto berries (long a natural remedy) in the treatment of prostate enlargement. If successful, the company crowed, the new product (available by prescription) could "capture a meaningful share of the current $1.3 billion global market for medicines addressing symptoms associated with benign prostate enlargement." This was to be only the beginning. PharmaPrint proposed to move next into the $3.8 billion market for depression treatment with a prescription version of St. John's wort. Followed by the development of proprietary pharmaceuticals derived from garlic, echinacea, ginger, and six other botanicals. With such a future in the planning stage, the American companies doubtless believe the prudent course would be to postpone any international agreement until they can set the standards.

Another cliché springs to mind --- You've made your bed; now you have to lie in it.

Sleep well!

 --- Copyright Betsey Culp 1997

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