PC SPES Was Adulterated

New evidence has surfaced that the herbal formula PC SPES has been adulterated with three potent prescription drugs. A detailed analysis, reported at the Annual Meeting of the American Association for Cancer Research (AACR), San Francisco, has confirmed the presence of the hormone-like diethylstilbestrol (DES), the blood thinner Warfarin (coumadin), and the painkiller indomethacin. DES in particular could account for the anti-prostate cancer effects seen with this formula.

The authors of the study include Robert Nagourney, MD, of Rational Therapeutics, Long Beach, and scientists from the University of California, San Diego, Biophysica Foundation of La Jolla, and the Palacky University in Olomouc, Czech Republic. Other scientists had repeatedly looked for DES but have been unable to confirm its presence. But the California and Czech scientists used highly sophisticated techniques to identify components that were lurking in a complex herbal mixture.

"Confirming the presence of DES was a case of not being able to see the tree for the forest," Dr. Nagourney said. "The results represent a chemical sleuth's job worthy of Sherlock Holmes."

Concerns over the contamination of PC SPES with prescription drugs began almost as soon as the product, which was manufactured in China, was marketed. Patients started developing blood clots, a typical side effect of DES, but also possibly caused by natural plant estrogens. More recently, a case was published in the New England Journal of Medicine of a patient who had a bleeding episode after taking PC SPES. This suggested contamination with Warfarin as well. Apparently someone decided to add Warfarin to the mixture to head off blood clots caused by their addition of DES. But since many patients were getting Warfarin from their doctors, this could have led to overdosing.

A Cruel Deception

It is clear now that cancer patients and their advocates have been the subject of a cruel deception. Patients were enticed into buying this high-priced "herbal" product for daily use, whose active ingredients included very low-cost generic drugs. But the monetary loss was the least of it. The patients' health was endangered by exposure to potent drugs in what they were repeatedly assured was a safe, over-the-counter mixture of eight herbs.

Many people upheld PC SPES as an example of an indigenous herbal formula that was developed outside the FDA approval process. While the clinical results with PC SPES are not in dispute, their safety and integrity are.

I have followed the PC SPES saga with great interest over the last five years. I first learned about it at a meeting at the New York Medical College, Valhalla, New York in March, 1997. Sophie Chen, PhD made an outstanding presentation. The head and deputy head of her laboratory were there to supported her work. Another attendee of that meeting, James Lewis, PhD, even wrote a whole book on the subject, The Herbal Remedy for Prostate Cancer. Many scientists got on board including, ironically, Dr. Nagourney. It seemed that a fusion was being forged between Western methodology and Traditional Chinese Medicine.

Sophie Chen worked hard to establish the activity of the different herbs in the formula. Where this process went wrong I do not know. Some additional details should emerge soon from a scientific paper by the California-Czech group. They may be able to piece together the sordid history from a serial analysis of PC SPES samples dating back to 1996.

At the website of Botaniclab, Inc., manufacturer of PC SPES, they are still citing the 1998 New England Journal of Medicine article that was unable to find any traces of DES. But they do state that even before the current investigation a lab did find traces of this synthetic hormone in their formula. They express "astonishment-- coupled with a determination to get "to get to the bottom of this." They also pledged a "follow the trail" investigation, although there are no results of this investigation at their web site.

What distinguished this fraud from many others is that with PC SPES the clinical results seemed to have been genuine. What was decidedly not genuine was the list of the ingredients and the manner in which they were working.

The people who adulterated PC SPES endangered the lives and well-being of cancer patients and possibly dissuaded them from taking more effective treatments. In the process, they set back the entire field of alternative medicine. They should be punished.

Ironically, the Latin word "SPES" means "hope." PC SPES was meant to give new hope to those suffering from prostate cancer. Instead it abused the hopes of thousands of trusting patients.

--Ralph W. Moss, Ph.D.

Sources:

Rational Therapeutics news release. "Chemical Analysis Confirms PC SPES Contains DES, Indomethacin and Warfarin; Results Presented at AACR Late Breaking Session" (April 9, 2002).

Weinrobe MC and Montgomery B. Acquired bleeding diathesis in a patient taking PC-SPES. N Engl J Med 2001;345:1213-1214.

DiPaola RS, et al. Clinical and biologic activity of an estrogenic herbal combination (PC-SPES) in prostate cancer. N Engl J Med. 1998;339:785-791.

Botaniclab encourages readers to contact their "toll-free hotline" (800-458-5854).