The Future of PC SPES Research Funding by NCCAM

August 26, 2002
Revised September 5, 2002

The U.S. Food and Drug Administration (FDA) has warned consumers to stop taking the dietary supplement/herbal products PC SPES and SPES because they contain undeclared prescription drug ingredients that could cause serious health effects if not taken under medical supervision. In February 2002, BotanicLab, the California-based manufacturer of the product, voluntarily recalled PC SPES and SPES nationwide. Subsequently, on June 1, 2002, BotanicLab officially closed and ceased operations.

PC SPES is a capsule that is marketed for "prostate health" and has been used by prostate cancer patients hoping to control their disease.

NCCAM has funded four research studies of PC SPES to learn about its safety, efficacy, and mechanisms of action; only one involves research with patients. In June, NCCAM placed all four studies on hold. Based on meetings since then with the scientists performing the major PC SPES studies, prostate cancer specialists, experts in herbal medicine, and representatives of government and industry, NCCAM will allow the three laboratory studies of existing PC SPES supplies to resume. These laboratory studies will seek to learn the cellular and molecular mechanisms of action of the herbs as opposed to the drug ingredients that contaminated the product.

Because of the promising data from the early studies of PC SPES and the public health importance of addressing advanced and hormone-refractory prostate cancer, NCCAM is also interested in resuming studies of PC SPES with patients and funding new laboratory studies of PC SPES. However, NCCAM can only do so when a fully characterized and standardized contaminant-free product using the original product 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.