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."