Botaniclab CEO "Stands Firm" Against PC SPES Allegations
BY JACQUIE STRAX ©
Latest Update -- PC SPES Second Test Report Confirms Diethylstilbestrol (DES), Lab Directors Say "No Question" 3 September, 2001
New York, PSA Rising, Saturday July 14, 2001- Dr. Sophie Chen, CEO and co-founder of BotanicLab, Brea, CA, said yesterday in a phone call from Valhalla, New York, "I stand firm in every way."
For one health community, the online prostate cancer survivor community, Dr. Chen's positive statement came after weeks of turmoil over PC SPES, BotanicLab's main product. Has PC SPES changed in any way, a number of people asked, between the "old" days from 1996 onward and the product on sale since around January this year?
Susan Domizi's husband, David Domizi, had been taking "old" PC SPES with some success to control his post-surgical recurrence of prostate cancer. Lately, when he started a a new batch, Susan said, his PSA began rising. This same pattern seemed to be occurring with at least 30 other men they heard about. Several of these men had never taken any hormones to treat their prostate cancer. The response rate for PC SPES in hormone naive men has been recorded in a recent trial run by Dr. Eric Small at UCSF as one hundred percent.
Susan Domizi hired a lab to test older and recent samples of PC SPES for DES (diethylstilbestrol). DES is a synthetic, man-made form of the female hormone estrogen. Until now the only estrogens identified in PC SPES have been "weak," plant hormones called phyto-estrogens.
No one in complementary medicine stands higher for a mix of scientific rigor with warmth and caring than Dr. Sophie Chen does among prostate cancer oncologists, and urologists and hundreds of patients. This past Tuesday, July 7, Dr. Chen stated that claims of a lab test's showing DES were based on "malicious rumors."
Earlier lab tests by the FDA, California Board of Health and a New Jersey medical college found no traces of DES. In the past three years, Dr. Chen has said, the supplement has been tested for DES by "three different reputable laboratories, based on random sample selection."
Yesterday PSA Rising called BotanicLab to ask about an apparent labeling discrepancy. Domizi had said earlier that the lab she hired had found DES in samples of Lot #5430125, Exp. 6/2002 and Lot#5436285, Exp. 3/2000. July 10, Dr. Chen noted that Domizi's testing lab "was unnamed and test results were unpublished," and stated, "Lot number 5436285 did not expire in 3/2000.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."
By and large, this remains a mystery. But a photograph of the sealed Lot#5436285 bottle submitted to the testing laboratory shows an expiration month of "3" (for March) not "10" (October). The full date looks like 3/00 (with diagonals through two zeros). If so this would seem to mean, according to the expiration code, that the bottle's contents were made (or packaged) in March 1998.
That year the Health Department of California tested for DES and found none, Chen said. But that would not explain how the code number came to be matched with a wrong expiration date.
PSA Rising asked Dr. Chen if the product could be counterfeit. She said that it could be --and she has no way of knowing. "All the product in California," she said, "I stand by." Once it is shipped out, she said, "I can't say." BotanicLab sends PC SPES "all over the world"; as far as Dr. Chen knows there has been no essential change in the product despite some recent problems with supply of herbs from China.
Ever since the start, Chen said, her policy has always been, "Straightforward, loud and clear -- Do everything right." Quality control inside the company is "consistent."
"I am proud of my work," Dr. Chen said. Patients only take this supplement "if nothing else can help them," she added. Helping patients is her main concern. "My heart is with them," she said at one point in our exclusive interview.
From what Chen said yesterday, problems of production are intense for this herbal compound. It is not a matter of one herb, but eight, seven of them from China. BotanicLab started small, she said, it did not have a "hundred million dollar start up." Demand has increased. The process of extraction from the herbs involves a tedious, expensive proprietary method. The company does not have its own extraction plant. Work must be contracted out in China. Not all factories are reliable. Chen says she "rejects factories below a certain standard."
Supply of the eight herbs in the mixture is complex. One of these herbs comes from Tibet (which is remote and occupied by China). The entire China side of production takes enormous work. "If you can't control raw material, you have no quality control," she pointed out.
Chen said she takes no salary for her work for BotanicLab. Her overwhelming motivation is caring and a desire to help. She is eager to do everything "positive" she possibly can to help patients.
So far, PC SPES is merely a supplement. "In the future," Chen said, "we intend to make it a botanic drug." She is working with Johns Hopkins University this summer on a clinical study looking in that direction. "I want to learn from PC SPES and SPES," Dr. Chen said.
Chen said she is working hard to make sure supply is met. She has seen no evidence of any change of the formula or variation in samples. She welcomes inspection at BotanicLab. Even if the product may not be "perfect," she and her partners want to "work together" with the cancer community. They hope to work in positive ways to learn more and gain better control of the product's potential to help patients.
Sophie Chen departs from New York today with two other doctors for a planned, two-week visit to China. While there she will continue to stand firm on quality but, she said, "I don't control everything in China." She is confident there is "no DES" in PC SPES and never has been, Dr. Chen said. "I know myself, nothing has changed."
Earlier:
No DES in Prostate Cancer Herbal Supplement, BotanicLab Vouches July 10 2001
Turmoil Over Prostate Cancer Supplement -- Estrogen Added or Missing? July 9 2001:12:32 AM EST