of Times -- Worst of Times . . . for Chinese Herbs
by Peter Golden, Publisher
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.
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
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.
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
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
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.
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.
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
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.
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.
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
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.
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
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.)
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
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.
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.
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.
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
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
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."