Action Alert: SPES and PC SPES

This is an urgent message to readers of The Moss Reports and our other publications. BotanicLab, an herbal product company based in Brea, Calif., is recalling two of its leading products, SPES and PC SPES, after the California Department of Public Health (CDHS) found the products contaminated with pharmaceutical drugs. PC SPES was found to be contaminated with a form of the anti-coagulant medication coumadin (Warfarin), while SPES was contaminated with the anti-anxiety medication alprazolam (Xanax).

Readers who have unused SPES and PC SPES capsules should return them in their original packaging to the PC SPES Recall Program, 2900-B Saturn Street, Brea, CA 92821 (1-800-458-5854). CDHS' Food and Drug Branch is continuing to investigate these products and can be reached at 1-800-495-3232 for more information. The U.S. Food and Drug Administration is also assisting in the investigation and monitoring of the recalls throughout the United States.

Patients should immediately stop using these products and seek medical advice, especially if they are currently using any prescription medication. Since there will be some delay before the two products are back on the market, they will need to discuss possible substitutes with their doctors.

The company's own analysis has shown that SPES was indeed contaminated with alprazolam. A company spokesperson told me that the highest dose found by the California Department of Health was 0.123 in one capsule. If patients took the recommended six capsules per day, they could theoretically ingest a dose of 0.738 milligrams of alprazolam. Alprazolam usually comes in tablets containing 0.25, 0.5 and 1.0 milligrams of the drug. Thus, the daily amount was within the range normally given for the treatment of anxiety.

The highest amount of coumadin found in PC SPES was said to be 0.21 milligrams. The normal dose of coumadin is between 1 and 10 milligrams. Thus, if you took six PC SPES pills you would receive 1.26 milligrams. The company claims, however, that its own tests of PC SPES found not coumadin, but a natural look-alike called coumarin. This is a chemical normally found in many plants, including alfalfa, dong quai and sweet and red clover. Re-testing of PC SPES is underway, but will not affect the recall.

According to the company, the accidental contamination of SPES occurred in China, at a company that supplies the ingredients for the two herbal mixtures. Apparently, these Chinese suppliers also manufacture or handle alprazolam. BotanicLab vigorously denies that there was any intent to adulterate the products either in China or the United States.

PC SPES can be very effective in treating prostate cancer. Its action is similar in many respects to them synthetic chemical, diethylstilbestrol (DES). This fueled persistent rumors that PC SPES was "spiked" with DES. However, according to the company's website, the California Department of Health Services, the U.S. Food and Drug Administration (FDA) and a number of independent laboratories have all failed to find DES in PC SPES. Ironically, just as the company was recovering from this false contamination charge, these true charges surfaced.

I hope that both SPES and PC SPES return soon. Patients who are reliant on PC SPES need to reconsider their options. First of all, talk to your physicians and see if there has been any damage from taking either of these formulas. As to treatment, I know of no substitutes for either product, but in the case of PC SPES, anti-hormonal drugs may be a possibility.

No doubt this is a setback. PC SPES in particular had begun to break down the barriers between conventional and "alternative" medicine. Now all these gains are imperiled by someone's gross negligence. This saga illustrates the difficulty of bringing the promise of Traditional Chinese Medicine (TCM) to the U.S. market. It is very difficult to exercise reasonable quality control from such a distance, and the opportunities for errors or worse abound. This scandal deals a blow to the prestige of herbal medicine in America. Some people will see this as further proof that herbal products need to be under the control of the FDA. But, as obvious as that may seem to some, it would not be a good solution.

FDA's century-long hostility to herbal medicine is well known. We need a sympathetic body of real experts on herbal medicine to oversee the safety and purity of herbal products. That board should look something like the current advisory board of the American Botanical Council (http://www.herbalgram.org/browse.php/advisory_board).  Problems with herbal products should be dealt with in a way that does not damage the integrity of herbal medicine as a whole.

BotanicLab's statement:
http://www.botaniclab.com/html/recallmore.html

California Health Department statement:
http://www.applications.dhs.ca.gov/pressreleases/store/pressreleases/02-03.html

--Ralph W. Moss, Ph.D.