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ALERT: On 2/8/02, the manufacturer of PC-Spes (Botanic Labs) issued a recall of PC-Spes after the California Department of Health Services issued a warning, as well as the FDA. See the FDA page for information. For the history of the controversy, see PSA-Rising Web site. The Wall St. Journal article of 3/26/02 is archived at Phoenix5.
IN TRIALS, POTION OF HERBS SHOWS PROMISE
by Thomas M. Burton
May 17, 2000
An old Chinese herbal remedy is gaining acceptance among some
American physicians as a treatment for prostate cancer.
The potion consists of eight mostly Chinese herbs such as
Baikal skullcap, rabdosta, mum and Dyer's woad and some small clinical trials
suggest it could help prolong the lives of men with advanced prostate cancer for
whom conventional treatment has failed. Prostate cancer kills about 40000 U.S.
men annually.
"This herbal compound can clearly cause prostate cancer
cells to die", says Aaron E. Katz, assistant professor of urology Columbia
University. A study he conducts among 33 patients found that after two months
87% experienced a drop in their levels of PSA - prostate-specifie antigen, a
protein that is associated with prostate cancer and is detected by a blood test:
after six months the percentage was 78%. "Our data did show reduction in
tumor volume", Dr. Katz says.
In a separate clinical trial of 60 patients at the University
of California at San Francisco and elsewhere, 75% of patients on the medicine so
far saw a drop of more than 50% PSA levels. PSA results aren't foolproof, and
a drop in PSA doesn't always mean greater longevity. But many oncologists are
convinced that a PSA drop of more than 50% is associated with longer life in
advanced prostate-cancer patients.
Despite such findings, hardly more than a handful of
urologists and oncologists even know about the remedy, called PC-SPES (PC
standing for prostate cancer, and SPES meaning hope in Latin). And because the
remedy has been subjected to only a few small trials, not all who do know about
it believe to its efficacy - or its safety.
PC-SPES's side effects are similar to those of conventional
hormone treatment (often with estrogen) for prostate cancer - lowered libido,
hot flashes, breast tenderness and enlargement, and blood clots in the veins of
the legs. But the clotting caused by PC-SPES is of particular concern because
the product an "alternative" over-the-counter product, isn't subjected to
the same rigorous testing as prescription drugs like estrogen. Thus, the
skeptics say the precise frequency of blood clots with the mixture really isn't
known the way it would be with prescription drugs. Moreover, a 1998 study in the
New England Journal of Medicine suggested simultaneously could experience
adverse side effects because of the combined effect of the two medicines.
"If this where a Merck drug, the Food and Drug
Administration would have all kinds of data, says Eric J. Small, a urologist and
researcher at the University of California at San Francisco. Instead, PC-SPES is
governed by 1994's Dietary Supplement Health and Education Act, which is much
more lenient in its regulatory setup. Alternative medicines can get: to market
relatively easily - on the theory that decades or centuries of use have shown
them to be safe.
A change I the law likely would be necessary to bring PC-SPES
under greater FDA scrutiny. As it is, use of the product "really needs to be
under the supervision of a physician," says Columbia's Dr. Katz. "I've
actually had to admit 5% of my patients to the hospital".
UCSF's Dr. Small says that the bloodclot side effect
appeared in "just under 4% of patients" and that the "really serious side
effects were relatively rare. Various other physicians outside clinical trials
are recommending PC-SPES. "I'm giving it to men who have failed conventional
hormone therapy. Most of my patients are having some response," says
University of Chicago surgery professor Gerald Chodak.
How this concoction came to the attention of top doctors is a
tale of cooperation between a Chinese herbal-medicine doctor and an American
chemist. The doctor is Allan Xuwui Wang, and it was his great-grandfather who
developed a rudimentary version of this potion as court physician to the last
Chinese emperor in the early 1900's. The recipe for that potion, believed from
the start to help with men's urological problems, passed from generation to
generation of Dr. Wang's family.
In 1987 Dr. Wang heard a U.S. chemist, Sophie Chen, then a
researcher with Bayer AG, expressed an interest in combining Chinese herbal
medicine and Western science. They began working together, doing animal research
and eventually coming up with the current version of their treatment.
Ultimately, the family of Dr. Chen now on the faculty of New
York Medical College in Valhalla, N.Y., founded a company called BotanicLab to
make and sell the product. Word-of-mouth testimony from users got PC-SPES off
the ground, and patients started telling their doctors about it. Then Dr. Small
and others began trials.
The most startling aspect of PC-SPES, in the view of Dr.
Small, is its effectiveness in "hormone-resistant" patients - men whose
conventional hormone treatment has failed and who have few options other than
chemotherapy. About 60% of such men in DR. Small's study had what he calls "a
good effect" - meaning a decline of the PSA level of 50% or more. Some
patients across the country tell of a PSA decline from a level of more than 100
to less than 1 normally a clear indication that tumor has shrunk.
There is even evidence of the medicine causing tumor
shrinkage in patients whose prostate cancer has metastasized. Tumors growing in
bones like those at the spine, pelvis and ribs have receded, DR. Small says. A
1999 report in the British Journal of Urology by German and American doctors
found a "highly significant reduction" in pain among men with metastatic
cancer that had resisted conventional therapy.
BotanicLab, PC-SPES's maker, delights in such findings. The
company, which is privately held and based in Brea, Calif., sells its product to
anyone who wants it and makes no mention of possible side effects, which
President James J. Peoples calls "an issue for a medical professional to deal
with".
Mr. Peoples declines to provide sales figures for PC-SPES but
estimates that the number of people buying it is "in the low thousands". That
could add up to annual revenue of $ 15 million or so, because the drug costs
anywhere from $ 300 to $ 500 monthly for typical doses. That's comparable with
the cost of many prescription drugs for prostate cancer, but insurers tend to
bear much of their cost. For PC-SPES, the patient pays the full freight.
But the cost is no deterrent for 59-year-old Harry Pinchot of
Oxnard, Calif. "PC-SPES has kept me alive", he says. After radiation,
hormone therapy and chemotherapy failed to keep his PSA down, he started taking
PC-SPES three years ago, and says his PSA dropped dramatically. "I'm a guy
who ran out of options in conventional medicine", he says.
Mario Menelly of Bellmore, N.Y., was in similar straits at about the same
time. His prostate cancer had metastasized and formed tumors in lymph nodes and
elsewhere. He started taking PC-SPES three years ago, and now his PSA has fallen
from a stratospheric 122 to 0.4, suggesting that the cancer has receded. He says
he has never felt better.
See The Wall St. Journal article of 3/26/02, archived at Phoenix5.
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