News Release
Los Angeles Times
October 21, 2000

A centuries-old Chinese herbal remedy is showing striking results in treating patients with advanced prostate cancer, even winning support from doctors despite a lack of federal oversight.

The blend of eight herbs, used by an estimated 10,000 men and sold over the counter, appears to reduce signs of tumor growth in patients who have exhausted all conventional treatments, according to studies in two well-regarded medical journals.

"I can't cite any other example in medicine where we've considered an herbal compound in an end-stage cancer situation and where other therapies have already failed," said Dr. Aaron E. Katz, an associate professor of urology at Columbia University College of Physicians and Surgeons.

The new studies, including one by Katz, on the effect of the supplement are almost certain to spark widespread demand. Almost 180,000 new cases of prostate cancer are diagnosed each year in the United States, with 40,000 deaths.

The product's potency, and the likelihood that its use will grow, sharply highlight the disparity between the heavy regulation that traditional drugs undergo and the virtual absence of regulation of supplements.

"We don't even know what the [supplement's] long-term side effects are," said Dr. Eric J. Small of UC San Francisco, coauthor of the other new study of the product, sold as PC SPES.

"For [drugs], the United States has extremely stringent regulations that are the envy of the world," said Dr. Ian M. Thompson Jr., chief of urology at the University of Texas Health Science Center in San Antonio. "But for something like this, we have no oversight.

" Accordingly, many unanswered questions about PC SPES remain: For whom is the remedy best suited? What dose is correct? How does it compare with other treatments?

Physicians are also worried because the supplement carries the risk of serious side effects. Most common are breast tenderness and enlargement because of herbs that act like estrogen. But 2% to 4% of patients also run the risk of blood clots, a potentially fatal problem, the studies found.

Because of this risk, Katz and other doctors say the therapy should generally be used only on patients who have not been helped by hormone therapy--even though the herbal supplement appears to reduce tumor growth in men with any stage or type of prostate cancer.

"This is not for someone in an early stage," Katz said. "We don't have enough long-term follow-up." In his study of 69 men, published this month in the Journal of Urology, 88% of patients taking the product experienced a significant drop in a protein called prostate specific antigen, or PSA, which is a marker for tumor growth.

Similar results, reported by Small, will appear in the November issue of the Journal of Clinical Oncology. Although there have been a handful of earlier papers on PC SPES, the two new studies are the first to examine the product in a large number of men.

Both studies also found that the herbal remedy reduced prostate specific antigen levels in men who had received hormone therapy, a standard approach to halt advanced disease, but who were still experiencing cancer growth. In Katz's group, 74% of those men responded to the herbal therapy; 54% in Small's study.

"There is a subset of patients where the hormone therapy does not work and the cancer continues to grow. That's the form of the disease that will eventually kill a patient," Katz said. The herbal treatment "is effective in those patients.
" Some studies have also shown a reduction in pain and tumor activity in men whose cancer has spread to the bone or brain.

The supplement's benefits may be another reason the product should not be sold over the counter, Thompson said. In an editorial in the Journal of Urology, he questions whether consumers should have to pay as much as $450 a month for a potentially lifesaving therapy. Over-the-counter herbal remedies are rarely covered by insurance plans. The supplement is sold in bottles of 60 capsules at $108. A typical regimen consists of six to nine capsules a day.

"The efficacy and toxicity of PC SPES should be a call to action for elected officials to demand testing of agents . . . that by any other definition are truly pharmaceuticals," said Thompson.

According to a Food and Drug Administration representative, the 1994 Dietary Supplement Health and Education Act bars makers of supplements from saying that their products "cure, treat, prevent or mitigate disease." The FDA has the authority to enforce that law, but has little additional power to regulate herbal supplements.

Efforts have been made to boost the regulators' authority--including a federal proposal that would require manufacturers to supply information about warnings or cautions surrounding a supplement's use. But there has been no sustained movement in the United States to hold supplements to the same testing and manufacturing laws as for drugs.

The federal government hasn't entirely ignored PC SPES. Earlier this month, the National Center for Complementary and Alternative Medicine, part of the National Institutes of Health, authorized a study of the remedy at the Johns Hopkins Center for Cancer Complementary Medicine.

But the studies lag behind the powerful anecdotal evidence for the therapy, which has been on the market since 1996.

Michael Cook, 49, was diagnosed at the age of 45 with prostate cancer that had already spread to his ribs and pelvis. Cook, a former magazine publisher who lives in Brea, was told that his only option was treatment with hormones, which he decided to forgo because studies have shown that hormones may work for only a limited time. After trying numerous other alternative remedies, his prostate specific antigen had skyrocketed and his bone pain had moved to his back.

"Then I heard about PC SPES," Cook said. After a month on the herbs, his antigen levels dropped from 80 to 0.2, he said.

"My doctor was stupefied by it," he said. "I've been on PC SPES for three years now, and I seem to be in complete remission."

The blend of herbs was brought to this country by Allan X. Wang, a Chinese herbal doctor who learned the formula from a long line of healers in his family, including a great-grandfather who ministered to the last Chinese emperor.

In 1987, Wang enlisted the talents of a Western-trained herbal specialist to tweak the mixture into its current formula.

PC SPES is now manufactured exclusively by privately held BotanicLab, which is based in Brea. Although under the law, supplement manufacturers can't claim to treat disease, BotanicLab acknowledges that "PC" stands for prostate cancer. "Spes" is Latin for hope.

Herbal Remedy

An over-the-counter herbal remedy is generating interest among men with prostate cancer. Two recent studies show that the product, called PC SPES, may have both benefits and risks.

Benefits

Could lower prostate-specific antigen levels in most men with prostate cancer.
Could work in some men for whom conventional therapies have failed.
Could help men whose disease has spread to other parts of the body.

Risks

Could increase the risk of blood clots in legs. Could cause breast enlargement and tenderness.
Could decrease sexual desire.
Could cause mild diarrhea and leg cramps in a small number of men.

Sources: Journal of Clinical Oncology, Journal of Urology