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When good treatments go bad

I was startled and very disappointed yesterday when I heard the shocking news about the popular herbal prostate health formula PC-SPES. I first read about in an e-mail I received from Ralph Moss, a Ph.D and a nationally recognized authority on alternative cancer treatments.

In February, we told you about the recall of PC-SPES. At that time, the California State Health Director issued a statement directing consumers to stop using PC-SPES immediately, warning that the product might contain warfarin (marketed under the name Coumadin), a blood thinner which can interact adversely with many other common drugs. This announcement was followed by a nationwide voluntary recall of PC-SPES by the product’s manufacturer, BotanicLab, while the product underwent further testing.

We now know that PC-SPES is adulterated with not one, but three prescription drugs.

At the annual meeting of the American Association for Cancer Research (AACR) last week, a team of researchers from California and the Czech Republic reported the results of their analysis of PC-SPES. The news wasn’t good. According to their report, PC-SPES contains not only warfarin, but also indomethacin (a pain killer), and diethylstilbestrol (DES). Each of these is a potent prescription drug.
Herbal detective work

The researchers began by following up on two sources of contradictory reports: cancer clinical trials which observed blood clotting, and a report of a PC-SPES patient with an abnormal tendency to spontaneous bleeding. The results of the study suggest that DES, which exhibits estrogen-like properties, was added to the formula to improve the effectiveness of PC-SPES in fighting prostate cancer. Then warfarin was apparently included to offset the blood-clotting effects of DES.

These drugs, added secretly to an otherwise natural therapy, created an accident that wouldn’t have to wait long to happen. It’s easy to imagine a case in which a patient might be prescribed a dosage of warfarin by his doctor, and then essentially receive an overdose of warfarin through his use of PC-SPES, leaving him vulnerable to spontaneous bleeding.

According to Dr. Moss, “Other scientists had repeatedly looked for DES [in PC-SPES] but have been unable to confirm its presence. The California and Czech scientists used highly sophisticated techniques to identify components that were lurking in a complex herbal mixture.”

John Sonego, a spokesman for BotanicLab, the California company that manufactures PC-SPES, told the Los Angeles Times that the company was surprised by the study revealing contaminants in their product. Sonego said, “Our testing, and testing from independent researchers, didn’t find DES. The Department of Health Services testing didn’t find anything but warfarin.” Sonego added that BotanicLab is taking action to make sure there is no further contamination. As stated when the problem originally surfaced earlier this year, Sonego maintains that the contamination problem may be associated with the suppliers in China. BotanicLab will soon turn over new PC-SPES samples to the California Department of Health Services, hoping to gain permission to resume sales.
Too little too late?

I doubt that that will happen. And even if it did, it’s hard for me to imagine how PC-SPES might regain the public trust. They touted their product as a safe, over-the-counter formula of natural herbs, charged a premium price, and then either they or their agent added inexpensive, generic drugs to the mix. Exactly who did the deceiving – the Chinese herbal supplier or the California manufacturer – doesn’t really matter in the end. The product they offered, a product that they positioned as providing hope, put their customers’ health at considerable risk.

And, as Dr. Moss also pointed out, “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 fact that this treatment was producing positive results for many men suffering from prostate cancer makes these revelations all the more unsettling.

If you are facing prostate cancer and looking for natural options – especially if you’ve been using PC-SPES – please go to www.hsionline.com and read the HSI e-Alert from last July (“New study shows diet can slow prostate cancer”). You’ll read about the ways that saw palmetto, flaxseed, milk thistle, and curcumin can help improve your prostate health. In the meantime, we’ll continue to keep you posted on further developments regarding PC-SPES — and how this controversy affects the progress of alternative medicine.
The baby with the bathwater

The field of natural medicine is always in an uphill fight for credibility. Obviously this sort of negative event is a potential setback to the integrity of the many responsible researchers dedicated to creating safe, natural therapies. And it will likely have the FDA, the pharmaceutical companies and the medical establishment screaming for broad regulations. But, as proponents of natural medicine, we welcome any independent study that exposes life-threatening hoaxes and deceptions. Every industry has its rogue elements. That doesn’t render the entire industry dishonest. Now, more than ever, it’s critical that we continue to support natural medicine and sound alternative therapies.

To Your Good Health,

Jenny Thompson
Health Sciences Institute

Sources:
AACR 93rd Annual Meeting: Abstract Number: LB152
Ralph W. Moss, Ph.D. Weekly Newsletter #32 04/16/02
Los Angeles Times (www.latimes.com)Copyright 1997-2002 by Institute of Health Sciences, L.L.C.

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