PC-SPES in the News

PC-SPES in the News

BREA, Calif.--PC-SPES, a prostate health supplement manufactured by BotanicLab(www.botaniclab.com), was cited in a letter in the Oct. 18 issue of the New England Journal of Medicine (NEJM) (345:1213-4, 2001) as a suspected cause of severe internal bleeding in one man. According to the NEJM letter(www.nejm.org), a Seattle man suffered severe internal bleeding after taking 12 doses ofPC-SPES daily for a month, which is twice the recommended dosage.

"Excessive use of this product may cause adverse reactions such as thrombosis, which is the opposite of hemorrhaging," said Barre Rorabaugh, acting president of BotanicLab. "No cases of hemorrhaging have ever been reported, and a lot of the experts say that it can't happen with PC-SPES."

The NEJM letter, written by Mark Weinrobe, M.D., and Brock Montgomery, M.D., describes the case of a 62-year-old man "with profound bleeding diathesis after one month of unsupervised use" of PC-SPES. The patient was self-treating with PC-SPES and multivitamins for hormone-refractory prostate cancer and nodal metastases (stage D1 disease). The man was admitted to the hospital suffering from abdominal pain and other symptoms, at which point physicians discovered severe internal bleeding. Physicians treated the man initially with two units of packed red cells and six units of plasma and administered vitamin K to stop the bleeding.

"The use of PC-SPES has been associated with increased states of deep venous thrombosis and pulmonary embolism, but to our knowledge its use has never been linked to hemorrhage," the authors wrote. "The transient, severe bleeding diathesis in this patient was probably the result of unsupervised use of PC-SPES ... unsupervised use of this preparation is not recommended."

In related news, two batches of PC-SPES tested positive for containing diethylstilbestrol (DES), a synthetic form of estrogen that was commonly used in the 1940s and 1950s to prevent miscarriage, but was shown to increase the risk of uterine cancer in children whose mothers took the compound. Susan Domizi, wife of a prostate cancer survivor who took PC-SPES for years, initiated the testing of PC-SPES when her husband experienced a reduction in side effects from PC-SPES, but experienced a rise in PSA (prostate-specific antigen), an indication that the cancer was not completely eradicated by his radical prostatectomy. Susan Domizi contracted an independent laboratory (which wished to remain anonymous) to do testing on new and old batches of PC-SPES. Two batches were found to have DES in them.

Disturbed by the results, the Domizis and a group of prostate cancer patients who were also experiencing rising PSAs and were using PC-SPES contracted a second laboratory, Rocky Mountain Instrumental Laboratories (RMIL) in Fort Collins, Colo., to do further research. RMIL confirmed the first lab's results.

"DES has never been an ingredient formulated in the composition of PC SPES," Rorabaugh said. "If DES was found in the product, we just don't know how it got in there."

When the results from RMIL were released, BotanicLab issued a request that consumers in possession of unopened bottles of PC-SPEC (Lot Nos. 5,430,125 and 5,438,285) send the samples back for further testing, as well as to ensure there had been no tampering with the seals. No samples were returned during the four-week deadline. However, the Food and Drug Administration (FDA) conducted testing on the supplement last July and reported finding no DES. The FDA report is published on BotanicLab's Web site(www.botaniclab.com).

According to information published in PSA Rising Magazine (www.psa-rising.com), the assays used by FDA were larger than those used by RMIL and would only have tested for amounts larger than those found by the independent laboratory.