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Best of Times -- Worst of Times . . . for Chinese Herbs
15 June 2000
by Peter Golden, Publisher

"It was the best of times; it was the worst of times," begins Charles Dickens's epic Tale of Two Cities. So are these the best and worst of times for Chinese herbs.

First, the "worst of times" news as reported in the June 8th edition of the New England Journal of Medicine (NEJM). There former FDA head Dr. David Kessler, now of Yale School of Medicine, editorializes on the dangers posed by unregulated herbs, specifically two varieties of Chinese origin whose similarity of name (in spoken Chinese) can lead to confusion, improper compounding and devastating results.

Drawing from cases of renal failure and cancer reported by a Belgian physician elsewhere in the NEJM, Kessler carefully distinguishes between A. fangchi, "an herb that is known to be nephrotoxic," and S. tetrandra, an apparently benign substance often used in weight loss preparations, the latter administered by a Belgian clinic with a 15-year record previously free of such damaging occurrences.

Kessler, a long-time advocate of reclassifying herbs as substances subject to government control, is circumspect in his indictment of A. fangchi. But beyond his scrupulously judicious observations and measured assessments, his message is consistent with his views as FDA commissioner in the early 1990s. Then, despite his best efforts to apply strict regulations to supplements and with a resulting onslaught of public outrage, the agency he headed was sharply curtailed by Congress in its latitude to regulate dietary supplements.

Regulation entails a host of issues

Kessler's pro-regulatory perspective on dietary supplements is seconded by Dr. Marcia Angell, Editor-In-Chief of the NEJM, whose position is straightforward: She advocates pulling them all from the shelves until they pass the same standards of clinical efficacy required of pharmaceuticals.

Such a position, while apparently rigorous, overlooks a host of constitutionally protected rights and competitive market issues that bear directly on the cost and availability of dietary supplements in the US. But to take them up here is to wander from the main points of this editorial.

Suffice it to say, the notion of a "good" government "protecting" a naive public from any risk of injury from dietary supplements does an injustice to both the impartiality of science and the rights of our citizens to access a broad class of relatively harmless -- and potentially highly beneficial -- substances.

Indeed, as non-Western medicine intersects with the proliferation of information over the Internet and with the spiraling cost of health care, the consumer at the center of the process is challenging the medical community to evaluate and, where appropriate, integrate supplementation into the care-giving process.

The "best of times" results

Now, for a different kind of news on the Chinese herb front: Drs. Aaron Katz of Columbia-Presbyterian Hospital and William Oh of the Dana-Farber Cancer Institute have reported within the last few weeks on other Chinese herbs and their relation to cancer, but with a markedly different result from the Belgian case reported in the NEJM.

Working with a branded product manufactured in Shanghai and known as PC-SPES (PC for prostate cancer, and SPES from the Latin word for hope), the researchers reported dramatic reductions in prostate cancer levels. The Katz study was published in the British Journal of Urology (fall 1999). Oh presented his findings to 22,000 cancer specialists from around the world at the May 2000 meeting of the American Society of Clinical Oncology in New Orleans. Subsequent press coverage has been widespread and positive.

According to the researchers, preliminary evidence shows significant reductions in cancer levels in more than 50% of study participants. Certain side effects, however, such as blood clots in about 5% of study participants, strongly suggest PC-SPES should only be used under the supervision of a physician.

Call for regulation

Meanwhile, Kessler notes that the presence of the cancer-causing substance in the Belgian weight-loss preparation was accidental. Yet his call for increased regulation in the US bears careful consideration. In summary, he suggests that a lack of quality standards for dietary supplements in the US clinches the argument: The public must be protected through active government oversight from such possibilities as arose in Belgium.

Ironically, Belgium is among the 15 European nations who impose high levels of regulation on herbs and other dietary substances. John Forte and Amala Raman, writing in the Spring 2000 edition of the Journal of Medicinal Food, note that Belgium maintains a public registry of approved and proscribed supplements. While different approaches are taken to supplement regulation by various European Union states, the overall effect is toward sharply lowered availability, increased prices and diminished potencies.

Quality question is central

Such observations must be placed into context of the risks to patients in the US from therapies using pharmaceutical drugs -- which are regulated very stringently by the FDA. In any given year, more than 100,000 patients die for a variety of reasons from medically prescribed drugs -- including dosage errors, interactions and side effects. (To put this in perspective, approximately the same number die from violent crime and traffic accidents combined.)

But Kessler's injunctions still ring clear: Who will set safety standards? Who will maintain registries of herbs and other supplements that represent a clear and present danger to public health? Answering such questions is essential for the development and maintenance of safety programs -- and establishing safety programs is vital to the maintenance of an open, competitive market.

Alternative model for setting quality and safety standards

For supplement producers seeking increased revenues and greater profits, and for consumers seeking easy access and enhanced benefits, the quality question is central. But who should develop and maintain quality programs is not a cut and dried issue. The computer and securities industries have experienced phenomenal growth in the last two decades. With minimal government supervision, both industries have brought hitherto unknown levels of productivity and wealth to the national economy.

The impact of these industries on both the national economy and the average consumer has been phenomenal. Twenty years ago the notion of a computer in most American homes was laughable. Further, the thought that a majority of adult Americans would have access to the Internet was beyond imagining.

Notably, electrical gear designed for use in hazardous environments must be certified by an independent laboratory as meeting insurance industry specifications in order to be purchased for an insured use -- all independent of government oversight. With insurers playing an ever-growing role in medical case management and long involved in product liability coverage, they make a logical participant in national quality programs.

Future uncertain

Whether non-medical quality models and non-governmental oversight represent a useful approach to supplement quality remains to be seen, but until a working coalition of producers, health care providers and consumers begins to address the issue, Dr. Kessler cannot be easily dismissed.

While the supplement industry demands independence from government regulation on one hand, on the other it must assume responsibility for implementing comprehensive self-regulation or risk remaining in a state of permanent controversy.

"True Label" programs, such as NNFA's pioneering effort to ensure that supplement bottle labels match supplement contents, are a beginning -- but until larger issues of safety and efficacy are addressed, for those who make and those who use supplements, it will continue to be "the best of times and the worst of times."end-of-story



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