NCCAM Goes Forward With PC SPES Studies

BETHESDA, Md.--Despite undeclared prescription drugs having been found in the product PC SPES from Brea, Calif.-based BotanicLab, the National Center for Complementary and Alternative Medicine (NCCAM) announced Aug. 26 that it will continue to study the product's effects on prostate health. The studies had been halted this past June as more evidence was mounting against the natural benefits of PC SPES. The three studies that resumed were lab tests; however, the fourth study, which involved humans, has been permanently halted.

In early February, the Food and Drug Administration (FDA) reported PC SPES had been voluntarily recalled in the United States for allegedly containing a prescription drug. A laboratory analysis conducted by the California Department of Health and Human Services (CDHHS) (www.dhs.ca.gov) found PC SPES to contain warfarin, a prescription blood thinner.

And in research that was just released Sept. 4 in the Journal of the National Cancer Institute (94, 17:1275-80, 2002) (jncicancerspectrum.oupjournals.org), PC SPES was found to have contained other pharmaceuticals. Researchers, led by Milos Sovak, M.D., of the University of California, San Diego, reported that in lots manufactured between 1996 and mid-1999, PC SPES contained indomethacin (in amounts ranging from 1.07 mg/g and 13.19 mg/g) and diethylstilbestrol (ranging from 107.3 mcg/g and 159.3 mcg/g). In products produced after that time period, the amount of indomethacin, a nonsteroidal anti-inflammatory drug marketed for easing pain and fever, and diethylstilbestrol, a nonsteroidal estrogen and a known carcinogen, found in the product decreased. Warfarin (in amounts from 341 mcg/d to 560 mcg/g) first started appearing in lots manufactured after July 1998.

However, NCCAM stated in its release that although PC SPES contained pharmaceuticals, data from PC SPES studies still remain promising. In one recent study, a particular herb in PC SPES--baicalin--was found to inhibit the proliferation of cancer cells (Prostate, 49, 4:285-92, 2001). Baicalin is a flavonoid non-nucleoside reverse transcriptase inhibitor (NNRTI) isolated from the traditional Chinese medicinal plant Scutellaria Baicalensis Georgi, or baikal skullcap.

In all, PC SPES contains eight herbs: baikal skullcap, Chinese licorice, Dyer's woad, mum, rabdosia, Reishi, san-qi ginseng and saw palmetto. NCCAM decided to resume its study of PC SPES after meeting with researchers who have studied the product, as well as with prostate cancer specialists, herbal medicine experts and representatives of government and industry. The researchers assigned to these studies will be investigating the cellular and molecular mechanisms of action of the herbs, as opposed to the drugs, in the product.

Nonetheless, NCCAM remains interested in resuming human studies using an herbal-only PC SPES, but the center stated that it can only do so when a fully contaminant-free product using the original herbal formulation becomes available. "NCCAM is open to working with potential new manufacturers of research-grade PC SPES so that studies of its safety and efficacy can proceed," according to an NCCAM press release.

An NCCAM spokesperson told INSIDER that although the center is not actively looking for a company to replicate an all-natural PC SPES formula, the center will be willing to work with the company that does produce the product.

However, PC SPES is considered a proprietary product owned by BotanicLab. How is the center working around this potential obstacle? "We are cognizant that the original PC SPES is a patented formula," according to the NCCAM spokesperson. "There is a patient coalition, Natural Approaches to Prostate Cancer Inc. [based in Portland, Ore.], working to develop an unadulterated PC SPES preparation."