No DES in Prostate Cancer Herbal Supplement, BotanicLab Vouches
BY JACQUELINE STRAX
New York, PSA Rising, Tuesday July 10, 2001- Dr. Sophie Chen, Chairman of the Board of BotanicLab, says that their product PC SPES has never contained DES (diethylstilbestrol), a non-steroidal synthetic estrogen.
Charges that a laboratory test has found DES in samples of two older Lots of the product are "malicious rumors," Chen said in a prepared statement released this evening to PC-SPES mailing list.
Chen said that in the past three years there have three tests for DES content in PC SPES. These tests were made by "three different reputable laboratories, based on random sample selection," she said.
The California Department of Health tested PC SPES in 1998 and so did, secondly, New Jersey Medical College for a study published in the New England Journal of Medicine (1998; 339,785-789). The FDA tested in 2000, Chen said. "All three tests were negative for DES," she said.
(Note: results of the DiPaolo's lab analysis are shown in this graphic from his NEJM article: Figure 3.)
"BotanicLab affirmatively states that our products are made from only the highest quality ingredients, manufactured under only the most stringent requirements, and continuously tested for consistency, purity and safety," Dr. Chen said.
"BotanicLab has standardized the biological activity of PC SPES so you can be assured that every bottle contains the same high quality, active ingredients," Chen said. "The biological activity of PC SPES is independent of and has nothing to do with DES."
Chen said that PC SPES "has been used in clinical trials in California, New York and Germany and has undergone independent testing at those institutions and been found to be safe and effective."
"PC SPES has been tested for years by the FDA, California Health Department and many certified independent laboratories," Chen went on, "that have the expertise to apply appropriate testing methods."
"Never in the 5-years history of PC SPES," Chen said, "has any legitimate, reputable laboratory result been reported that shows that PC SPES contains anything other than a patent protected formula of consistent quality and biological activity. No drug or contaminant has ever been found in any lots of PC SPES. Every test shows that PC SPES contains the formula it was designed to contain. Never in 5 years has any contaminant such as DES been found in any products or lots."
Chen said claims and complaints made on the PC SPES mailing list (reported by PSA Rising July 7-9) were factually wrong. Regarding "specific allegations made in a recent chat room," she said, "many details associated with this rumor are incorrect."
Susan Domizi, wife of a prostate cancer patient, alleged last week that according to results of tests she and her husband paid for, samples of Lot #5430125, Exp. 6/2002 and Lot#5436285, Exp. 3/2000 contain DES.
Noting that "the testing lab was unnamed and test results were unpublished," Dr. Chen said tonight: "Lot number 5436285 did not expire in 3/2000. Our record shows that this lot of PC SPES was manufactured in October 1996 and expired in October 1998. Claims to have tested this lot of product almost three years beyond its expiration date means the sample was decomposed and the validity of any results is suspected."
The shelf life of BotanicLab's products "is only two years from the date of manufacturing," Chen said, "and is clearly marked on every label."
About Lot number 5430125, which the Domizis said also tested positive for DES, Chen said that it "was drawn from the same ingredients as the lot number 5430171 and they were manufactured within one month each other."
On August 10, 2000, she said, "the FDA visited BotanicLab's headquarters and took random samples of PC SPES lot number 5430171. The test results were negative for any substance not acceptable to FDA, which presumably included DES. The FDA communication on September 6, 2000 clearly said that PC SPES is safe."
The company "understands it is unsettling," Chen said, for PC SPES users and their friends "to hear malicious rumors."
"We want to assure you that these rumors are untrue," she added. "You can rely on BotanicLab, and only BotanicLab, to provide you with only the highest quality, most biologically active products, containing only the ingredients listed on the label, and manufactured with a patented process to meet your special needs."
Chen did not address complaints from users that samples from specific Lots do not appear to be causing nipple soreness and other typical PC SPES side effects.
Dr. Chen was slated to address a prostate cancer support group in Morristown, NJ on July 18. Today she announced that she is unable to attend that meeting as she will be out of the country on that date.
Earlier:
Turmoil Over Prostate Cancer Supplement -- Estrogen Added or Missing? July 9 2001:12:32 AM EST