Pcspes A Cautionary Tale

The most popular herbal treatment for prostate cancer has been PC-SPES, the name being an abbreviation of prostate cancer and the Latin word for "hope." It was commercially available from 1996 until 2002, when its manufacturer, BotanicLab in Brea, California, abruptly shut down. At the time, it was estimated that approximately ten thousand men with prostate cancer were taking PC-SPES and a bottle of sixty capsules was selling for $108. The recommended dose ranged from six to twelve capsules per day, depending on the severity of the man's cancer.8 If all the men had been taking six capsules a day, sales would have totaled $3.2 million each month.

PC-SPES was formulated by Sophie Chen, a Taiwanese immigrant who trained in chemistry and initially worked at several large drug companies. She also held an adjunct faculty position at New York Medical College. Her principal collaborator was Xuhui "Allan" Wang, an herbalist who claimed that his great-grandfather had been court physician to a Chinese emperor.9 Chen and Wang formulated PC-SPES as a combination of six Chinese herbs, a Chinese mushroom, and the American herb saw palmetto. These herbs are believed to have mild estrogenic activity, thus suppressing testosterone. Together with Chen's brother, John, they began to manufacture and sell their new formulation. They advertised it as merely being useful for "prostate health,'' not specifically for cancer or any disease condition, thus avoiding all regulations that require testing for safety and efficacy.

The formulation was an immediate success. Men with prostate cancer noted a rapid decrease in their PSA, and word spread quickly through the Internet and prostate cancer survivor groups. In 1999 The Herbal Remedy for Prostate Cancer was published by James Lewis, a Ph.D. in education administration who himself had prostate cancer. It extolled PC-SPES and acknowledged that Sophie Chen had "read the entire manuscript and offered her suggestions which provide accurate assessment of its contents.''10

By 1999, prostate cancer researchers had begun testing PC-SPES and reporting that it did indeed lower the PSA and shrink the prostate. Michael Milken's Prostate Cancer Foundation gave Chen a grant of $150,000 and provided an additional $500,000 for researchers to test it. The National Center for Complementary and Alternative Medicine, part of the National Institutes of Health, also provided funds. Some of the researchers who were involved in testing PC-SPES were, like Sophie Chen, on the faculty of New York Medical College and from her received ''small amounts of company stock.''11

From the earliest use of PC-SPES, certain side effects were noted. Most prominent was breast enlargement, which was ''nearly universal''; in some cases breasts grew so large that men ''had to have them surgically removed.'' Also noted were blood clots in the leg— thromboembolism—which ''occurred in approximately 5 percent of patients.'' Several people, including some of the researchers who were testing PC-SPES, noted the similarity of its side effects to those of diethylstilbestrol (DES), an estrogen compound that effectively suppresses testosterone but that has serious side effects, including thromboembolism. In 2001 an additional side effect of PC-SPES was noted when several men who were taking it began to bleed mysteriously. In one case, reported in a medical journal, a man had ''turned up in an emergency room in Idaho bleeding from every orifice, and the hospital had barely saved him.''12

The denouement of the PC-SPES tale was provided not by the National Institutes of Health or the Food and Drug Administration, but rather by a Connecticut housewife.13 Her husband had been taking PC-SPES with effective lowering of his PSA until 2001, when the formulation suddenly stopped working. She decided to have various lots of PC-SPES tested for adulteration, and the tests came back positive: the lots of PC-SPES that had been effective had been adulterated with DES, and the lots that were no longer effective did not contain DES. She posted the information on the Internet, and it was quickly confirmed by other laboratories.

In January 2002, the state of California opened an investigation, and it was shown that PC-SPES had been adulterated with DES since its earliest manufacture in 1996. It was also found to be adulterated

with indomethacin, an anti-inflammatory drug, and warfarin, an anticlotting drug presumably added to try to counteract the DES-caused thromboembolism. In a further investigation by California officials, ''the state found adulteration with some pharmaceutical agent in every BotanicLab product that it could test.''14

BotanicLab as a company pleaded no contest to a felony charge and shut down. Sophie Chen and her brother pleaded no contest to misdemeanor charges, were fined nearly $500,000, and were barred from the dietary supplement business in California. Ms. Chen denied any wrongdoing: ''I am just a scientist,'' she said. ''I am only trying to find a cure for cancer.''15

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