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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.


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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