Some Chinese Herb Remedies Called Toxic Raja Mishra
February 01, 2001
c.2001 The Boston Globe
When a small Wellesley, Mass., company specializing in Chinese
herbal remedies abruptly pulled its AllerRelief pills off the
shelves of natural-food stores two weeks ago, there was scant
notice.
But the company, BMK International, was acting on orders from
the U.S. Food and Drug Administration, which found that the
allergy-fighting compound was contaminated with a toxin shown to
damage kidneys severely and possibly cause cancer.
The incident was not an isolated event, say government
officials, but the tip of an iceberg that could have serious health
consequences for a small but rapidly growing group of consumers who
are turning to Chinese herbalism to ease their pains and soothe
their minds.
Dozens of Chinese herbal remedies on sale in the United States,
they believe, contain the toxin, aristolochic acid, which naturally
occurs in many of the herbs used in these centuries-old Chinese
healing compounds. The toxin has already been fingered in a mass
outbreak of kidney trauma in Belgium, possibly causing cancers in
more than 30 people there, and is suspected of the same in several
other countries.
Federal officials are unsure how widespread the contamination
is. Herbal manufacturers insist it is quite limited.
Last summer, the FDA aggressively began seizing cargo shipments
from China suspected of carrying the worrisome herbs, according to
federal trade documents. The agency bombarded doctors with letters
urging a detailed exploration of their patients' Chinese herbal
remedy use. And it warned the herbal industry to police itself,
both in the United States and in China, where many of the herbs
originate.
Herbal companies contend that the FDA is being heavy-handed,
taking dramatic actions based on minimal evidence. But the FDA and
health advocates say the effort is actually evidence of the
agency's impotence in controlling herbal and dietary supplements.
Federal law prevents the FDA from analyzing and approving
supplements before they are sold, as it does with pharmaceuticals.
It can only act, as it did with BMK, if there is imminent public
danger. In other words, when the questionable products are already
on sale.
``I think the FDA has not been overreactive with aristolochic
acid,'' said Mark Blumenthal, executive director of the American
Botanical Council, an herbal remedy research group in Austin,
Texas. ``They have a legitimate reason for concern.''
The actual policing of the marketplace appears to be going
slowly. BMK was the third company forced to recall its product in
nine months. Two other California-based companies, Lotus Herbs and
FineMost-QualiHerb, also agreed to recall some of their products
voluntarily.
American-based herbal companies have long eschewed aristolochic
acid-containing herbs. But smaller companies without extensive
quality control are often victim of the haphazard ways of Chinese
herb importers, said FDA officials. The most dramatic example
occurred in Belgium, the case that triggered the FDA's actions.
There, a weight-loss clinic prescribed a pill containing Chinese
herbs during the early 1990s. In the pills, an herb known by the
Chinese name ``han fang ji'' was replaced with the aristolochic
acid-containing ``guang fang ji,'' Belgian health authorities
reported. Similarly named herbs are often swapped, investigators
said.
About 100 patients from the clinic developed kidney damage; 70
required kidney transplants or dialysis. Further tests found 18
cases of bladder cancer and 19 cases of dysplasia, changes in cells
that are often a precursor to cancer. The findings were published
in the New England Journal of Medicine last year.
Last March, the Ministry of Public Health in Belgium advised
everyone who had consumed Chinese herbal remedies in the past 10
years to get their kidneys checked.
Reports of similar problems surfaced in France, Spain, Japan and
Australia. Even Malaysia, a nation long used to Chinese herbalism,
warned its consumers.
The findings in Belgium did not meet the scientific gold
standard of a randomized double-blind trial. Cause and effect were
not definitely established. But the mounting anecdotes were enough
for the FDA.
On May 31, 2000, it sent a letter to thousands of U.S. doctors
urging that ``a thorough history of use of dietary supplements as
well as traditional medicines, including Chinese and Ayurvedic
(Indian) should be routinely sought as part of the medical history,
particularly in cases of unexplained interstitial renal fibrosis.''
The agency warned that ``patients taking aristolochic acid may
be at increased risk of developing (cancerous) malignancies.''
Herbal product companies were told to test their goods
rigorously to make sure they are free from aristolochic acids. This
was no problem for larger companies, said industry experts, but was
a daunting chore for the smaller ones.
``It is probably true that there are companies that aren't as
careful as they should be,'' said Robert McCaleb, president of the
Herb Research Foundation, a Boulder, Colo.-based industry group.
Last fall, the FDA began the slow process of randomly testing
the Chinese herbal products suspected of containing aristolochic
acid that were already on the market. Samples were sent to a lab in
Cincinnati for chemical analysis.
The results of one test landed on the desk of investigators in
the FDA's New England bureau, based in Stoneham. An investigator
informed BMK that its product contained aristolochic acid.
The notice surprised Phyllis Tan, BMK's founder. She learned the
craft of Chinese herbalism by apprenticing at her mother's
storefront herbal clinic, which served Chicago's Chinese community.
The Chinese herbalist is more like a chef, albeit a precise one,
than a modern pharmacist. They listen to the complaints of their
customers and fashion remedies that utilize hundreds of different
combinations of the 450 herbs that form the palette of Chinese
herbalism. The knowledge base stretches back more than a thousand
years and has been rigorously catalogued by herbal colleges in
China.
Safety is of utmost concern, said practitioners, and an herb
must be used safely for 400 years before mainstream Chinese
herbalists will embrace it. Their remedies are used worldwide.
Given this popularity, asks Tan, why haven't cases of injury turned
up?
``If this was of great harm in the U.S., you would have
definitely seen cases by now. And you would be seeing them in Asia
in large numbers,'' she said. ``Nobody knows what really happened
to these people in Belgium.''
She noted that numerous fruits contain harmless amounts of
cyanide, which, in intense doses, is lethal.
``Apricots contain cyanide in them naturally. But we can eat as
many as we want. We're not going to die,'' said Tan, adding that
while aristolochic acid is clearly toxic when concentrated, most of
the Chinese herbs that the FDA is concerned with contain only trace
amounts.
Furthermore, she asserts that the FDA did not make her small
company aware of all the ingredients it considered suspect.
The FDA's role in monitoring the herbal industry was sharply
curtailed in 1994, when Congress unanimously passed the Dietary
Supplement Health and Education Act of 1994. This forced the FDA to
prove that a particular herb was dangerous before regulating it,
the opposite of typical drug policy, where pharmaceutical companies
must prove their products' safety before selling them.
``Congress has put the FDA in the position of being able to act
only after the fact and after substantial harm has already
occurred,'' wrote former FDA commissioner Dr. David Kessler in an
editorial accompanying the study on the Belgian patients.
(The Boston Globe Web site is at http://www.boston.com/globe/)
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