Ralph W. Moss, Ph.D. Weekly CancerDecisions.com
Newsletter #23 02/12/02
Action Alert: SPES and PC SPES
This is an urgent message to readers of The Moss
Reports and our other publications. BotanicLab, an
herbal product company based in Brea, Calif., is
recalling two of its leading products, SPES and PC
SPES, after the California Department of Public Health
(CDHS) found the products contaminated with
pharmaceutical drugs. PC SPES was found to be
contaminated with a form of the anti-coagulant
medication coumadin (Warfarin), while SPES was
contaminated with the anti-anxiety medication
Readers who have unused SPES and PC SPES capsules
should return them in their original packaging to the
PC SPES Recall Program, 2900-B Saturn Street, Brea, CA
92821 (1-800-458-5854). CDHS' Food and Drug Branch is
continuing to investigate these products and can be
reached at 1-800-495-3232 for more information. The
U.S. Food and Drug Administration is also assisting in
the investigation and monitoring of the recalls
throughout the United States.
Patients should immediately stop using these products
and seek medical advice, especially if they are
currently using any prescription medication. Since
there will be some delay before the two products are
back on the market, they will need to discuss possible
substitutes with their doctors.
The company's own analysis has shown that SPES was
indeed contaminated with alprazolam. A company
spokesperson told me that the highest dose found by
the California Department of Health was 0.123 in one
capsule. If patients took the recommended six capsules
per day, they could theoretically ingest a dose of
0.738 milligrams of alprazolam. Alprazolam usually
comes in tablets containing 0.25, 0.5 and 1.0
milligrams of the drug. Thus, the daily amount was
within the range normally given for the treatment
The highest amount of coumadin found in PC SPES was
said to be 0.21 milligrams. The normal dose of
coumadin is between 1 and 10 milligrams. Thus, if you
took six PC SPES pills you would receive 1.26
milligrams. The company claims, however, that its own
tests of PC SPES found not coumadin, but a natural
look-alike called coumarin. This is a chemical
normally found in many plants, including alfalfa, dong
quai and sweet and red clover. Re-testing of PC SPES
is underway, but will not affect the recall.
According to the company, the accidental contamination
of SPES occurred in China, at a company that supplies
the ingredients for the two herbal mixtures.
Apparently, these Chinese suppliers also manufacture
or handle alprazolam. BotanicLab vigorously denies
that there was any intent to adulterate the products
either in China or the United States.
PC SPES can be very effective in treating prostate
cancer. Its action is similar in many respects to the
synthetic chemical, diethylstilbestrol (DES). This
fueled persistent rumors that PC SPES was "spiked"
with DES. However, according to the company's
website, the California Department of Health Services,
the US Food and Drug Administration (FDA) and a number
of independent laboratories have all failed to find DES
in PC SPES. Ironically, just as the company was
recovering from this false contamination charge, these
true charges surfaced.
I hope that both SPES and PC SPES return soon.
Patients who are reliant on PC SPES need to reconsider
their options. First of all, talk to your physicians
and see if there has been any damage from taking
either of these formulas. As to treatment, I know of
no substitutes for either product, but in the case of
PC SPES, anti-hormonal drugs may be a possibility.
No doubt this is a setback. PC SPES in particular had
begun to break down the barriers between conventional
and "alternative" medicine. Now all these gains are
imperiled by someone's gross negligence. This saga
illustrates the difficulty of bringing the promise of
Traditional Chinese Medicine (TCM) to the U.S. market. It
is very difficult to exercise reasonable quality
control from such a distance, and the opportunities
for errors or worse abound. This scandal deals a blow
to the prestige of herbal medicine in America. Some
people will see this as further proof that herbal
products need to be under the control of the FDA. But,
as obvious as that may seem to some, it would not be a
FDA's century-long hostility to herbal medicine is
well known. We need a sympathetic body of real experts
on herbal medicine to oversee the safety and purity of
herbal products. That board should look something like
the current advisory board of the American Botanical
( http://www.herbalgram.org/browse.php/advisory_board ).
Problems with herbal products should be dealt with in
a way that does not damage the integrity of herbal
medicine as a whole.
For further information:
California Health Department statement:
---Ralph W. Moss, Ph.D.
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