The Rise and Fall of PC-SPES
and Its Marketers

Stephen Barrett, M.D.

PC SPES was developed in the early 1990s and patented in 1997 [1] by a chemist named Sophie Chen, Ph.D., who claimed to have developed the formula by integrating modern science and ancient Chinese herbal wisdom. Chen and her associates claimed that it and related products were breakthrough herbal formulas supported by years of research by M.D. and Ph.D. scientists. PC SPES was also said to be a centuries-old Chinese remedy that could fight prostate cancer by boosting the immune system.

By the mid-1990s, BotanicLab (Brea, California) was marketing these two products as dietary supplements—PC SPES "for prostate health" and SPES as an "immune system formula" [2]—and claims about positive effects were widely circulating on the Internet. At the same time, scientific studies reporting benefit aroused hopes that it might be an effective treatment. However, the presence of a synthetic estrogen such as diethylstilbesterol (DES) was suspected early in the clinical use of PC SPES after reports in the literature noted the product's estrogen-like ability to lower prostate-specific antigen (PSA) levels in prostate cancer patients, and the reported side effects of treatment were similar to those of estrogen therapy. Tests of PC-SPES found that its ingredients varied from lot to lot but in 2002 it was proven that many of the lots had been contaminated with prescription drug ingredients such as indomethacin, warfarin (a blood thinner), and/or DES [3]. After this was demonstrated, the FDA and the California Department of Health warned consumers to stop using PC SPES and SPES and BotanicLab issued a recall [4,5], and cancer survivors who had used PC SPES filed a class-action lawsuit against International Medical Research (BotanicLab's parent company) and a long list of other PC SPES sellers [6]. In June 2002, International Medical Research went out of business, saying it was devastated by the costs of the lawsuit and the recall of the two drugs. That same month, the California health department warned that seven other BotanicLab products (Arthrin, HepaStat, Neutralis, OA Plus, Osporo, Poena, and RA SPES) might be contaminated with prescription-only ingredients.

In 2003, the Orange County District Attorney charged International Medical Research, Inc. and three of its officers with 14 criminal counts relating to the marketing of products that were laced with prescription drug ingredients [7].The charges were settled with "no contest" pleas and consent agreements. Under the agreements, Sophie Chen,brother John Chen, and Allan Xuhui Wang admitted to single misdemeanors involving the marketing of misbranded and adulterated food. Their defunct company pleaded no contest to the felony count of producing a product that presented a danger to the public. The corporation agreed to pay $350,000, the Chens agreed to pay $46,500 each, and Wang agreed to pay $56,500. The court that accepted the plea agreements also issued a permanent injunction barring the defendants from any connection with the marketing of drugs or dietary supplements in California [8]. The defendants still faced civil suits related to the injury or death of former customers, but I don't know the outcome of these suits.

The National Cancer Institute has published a lenghty article about the history of PC SPES and related scientific studies [9]. Of course, the presence of drug ingredients in PC SPES makes much of the research uninterpretable. The summary may be of value to historians and possibly some herbal researchers, but patients concerned about prostate cancer will gain little or nothing by reading it.

References

  1. Chen S, Wang X. Herbal composition for treating prostate carcinoma. U.S. Patent # 5665393. Sept 9, 1997.
  2. Documents downloaded from the BotanicLab Web site, February, 2002.
  3. Sovak M and others. Herbal composition PC-SPES for management of prostate cancer: Identification of active principles. Journal of the National Cancer Institute 94:1275-1281, 2002.
  4. Chen J. Urgent dietary supplement recall. BotanicLab Web site, Feb 8, 2002.
  5. State health director warns consumers about prescription drugs in herbal products. California Dept. of Health Services news release, Feb 7, 2002]
  6. Paul Meco, et al. v. International Medical Research d/b/a BotanicLab, Santa Monica Homeopathic Pharmacy, Novaspes Research Inc. and Novaspes, Inc. et al. Los Angeles Superior Court case no. BC267700, filed February 2002.
  7. Felony complaint. The people of the State of California vs. John Chun Hsiung Chen aka John Chun Hsuing, Xuhui Wang aka Allen Xuhui Wang, Sophie S. Chen aka Sophie S. Fan, and International Medical Research, Inc., d/b/a Botanic Lab. Case No. 03CF1520, Superior Court of California, County of Orange, Central Justice Center, May 8, 2003.
  8. Stipulation for and order for injunction and final judgment. The people of the State of California vs. John H. Chun et al. Superior Court of California, County of Orange, Central Justice Center Case No 03CC12503, filed Dec 18, 2003.
  9. PC-SPES (PDQ): Health professional version. Natuional Cancer Institute Web site, updated July 27, 2017.

This article was posted on March 23, 2018.

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