NCCAM Goes Forward With PC SPES Studies 29462

NCCAM Goes Forward With PC SPES Studies

BETHESDA, Md.--Despite undeclared prescription drugs havingbeen found in the product PC SPES from Brea, Calif.-based BotanicLab, theNational Center for Complementary and Alternative Medicine (NCCAM) announcedAug. 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 againstthe 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 SPEShad been voluntarily recalled in the United States for allegedly containing aprescription drug. A laboratory analysis conducted by the California Departmentof 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 theNational Cancer Institute (94, 17:1275-80, 2002) (jncicancerspectrum.oupjournals.org),PC SPES was found to have contained other pharmaceuticals. Researchers, led byMilos Sovak, M.D., of the University of California, San Diego, reported that inlots manufactured between 1996 and mid-1999, PC SPES contained indomethacin (inamounts ranging from 1.07 mg/g and 13.19 mg/g) and diethylstilbestrol (rangingfrom 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 foreasing pain and fever, and diethylstilbestrol, a nonsteroidal estrogen and aknown carcinogen, found in the product decreased. Warfarin (in amounts from 341mcg/d to 560 mcg/g) first started appearing in lots manufactured after July1998.

However, NCCAM stated in its release that although PC SPES containedpharmaceuticals, data from PC SPES studies still remain promising. In one recentstudy, a particular herb in PC SPES--baicalin--was found to inhibit theproliferation of cancer cells (Prostate, 49, 4:285-92, 2001). Baicalin isa flavonoid non-nucleoside reverse transcriptase inhibitor (NNRTI) isolated fromthe traditional Chinese medicinal plant Scutellaria Baicalensis Georgi, orbaikal skullcap.

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

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

An NCCAM spokesperson told INSIDER that although the center is notactively looking for a company to replicate an all-natural PC SPES formula, thecenter will be willing to work with the company that does produce the product.

However, PC SPES is considered a proprietary product owned by BotanicLab. Howis the center working around this potential obstacle? "We are cognizantthat the original PC SPES is a patented formula," according to the NCCAMspokesperson. "There is a patient coalition, Natural Approaches to ProstateCancer Inc. [based in Portland, Ore.], working to develop an unadulterated PCSPES preparation."