BotanicLab Denies Synthetics in PC SPES, Admits Xanax in SPES
Complaints about reporting
BY JACQUELINE STRAX
New York: PSA Rising, February 7, 2002. BotanicLab, a supplement company in Brea, CA, on its website now denies that any DES (Diethylstilbestrol, a synthetic estrogen) has ever been found in its dietary supplement PC SPES.
BotanicLab blames a PSA Rising article Feb 4, and says the article "implies that [California Department of Health Services] DHS had discovered DES in PC SPES. This is simply not true."
PSA Rising's article did not at all imply this. What we said, quite accurately, was that California Department of Health has never discovered DES in PC SPES:
"unlike the other three laboratories, California state health authority's have never found [DES]."
What we implied, accurately as we believe, is that while they have never detected it, despite looking for it, CDHS has evidence to believe that at least one other lab has found it. UCSF tests found it, and according to a CDHS spokeperson, the lead investigator in a UCSF trial has passed the information to Food and Drug Agency (FDA) and National Cancer Institute (NCI).
Some people say CDHS and FDA's thresholds for DES are set too high to find the low levels of DES that other testers have found by more sensitive methods. CDHS told us that finding DES is "tricky."
In the past six months, two patient-hired laboratory tests have found DES in PC SPES. UCSF/Dana-Farber trial of PC SPES versus DES, as we reported last week, has closed on account of DES detected in all 4 trial lots of PC SPES.
So -- we made quite clear that CDHS have never foubd DES -- and we also reported that CDHS is aware that Dr. Eric Small, chief UCSF trial investigator, has passed on his finding to Food and Drug Administration (FDA) and National Cancer Institute (NCI).
As to the other two matters -- PSA Rising reported Monday 4 Feb that California Department of Health Services state that they have found a blood-thinner, Warfarin, in 8 lots of PC SPES. It was in every one of the lots they tested for that drug.
BotanicLab now says its own laboratory tests indicate that the chemical found in PC SPES is Coumarin. BotanicLab says:
DHS test results indicated some lots of PC SPES contained a contaminant they believe is Warfarin, a synthetic blood thinner, and recommended BotanicLab issue a product recall for PC SPES.
Our independent lab results reported the "synthetic contaminant" was not Warfarin, but may instead be a phyto-Coumarin (a naturally occurring compound found in green plants) that may "mimic" Warfarin in lab testing.
As far as we know, BotanicLab did not tell the public about the Warfarin in PC SPES until after we reported it. Nor did have they told the public that CDHS has recenty found much higher levels of Xanax in SPES than they themselves were stating in their recall notice.
COUMARIN
"Coumarin is found in a variety of plants such as Tonka bean, lavender, sweet clover grass, and licorice, but also occurs in food plants such as strawberries, apricots, cherries, and cinnamon. It is thought to work by serving as a pesticide for the plants that produce it.""Chemically, coumarin can occur either free or combined with the sugar glucose to produce a coumarin glycoside. Medically, coumarin glycosides have been shown to have blood-thinning, anti-fungicidal, and anti-tumor activities. Dicumarol, a coumarin glycoside better known as warfarin, is the most commonly used oral anticoagulant medication."
Herbal Medicines Reported to Have Effects on Coagulation
Interactions between Warfarin and Herbal Products www.cshp.ca/...pdf
Healthbasic - Licorice may contain coumarin & interact with warfarin
BotanicLab could be right that the Warfarin may turn out to be naturally-occuring. But if so, why has it never been identified and publicized in all the years of PC SPES production?
Coumarin is the parent organic compound of a class of naturally occurring phytochemicals found in many plant species. Coumarin glycosides have been shown to have blood-thinning, anti-fungicidal, and anti-tumor activities. Licorice in PC SPES may contribute some coumarin. If plant coumarin is present, the anti-coagulant effect might balance some clotting effects of PC SPES's estrogenic properties. Or as one writer says, "The presence of estrogen-like substances in licorice may increase the production of procoagulant factors which, in turn, may inhibit the anticoagulant action of heparin or coumarin."
Does anyone know if this "natural" warfarin keeps a steady level or jumps around? What if you take warfarin or aspirin to counteract estrogenic effects of PC SPES? Most users are told to do this. There's anecdotal evidence that, lately, PC SPES has been anti-coagulant. A patient starting out on 9 PC SPES per day, not taking any blood thinner, saw his INR (clotting time ratio) go from a normal 1 to a high 3.7 in one week.
BotanicLab says PSA Rising's Feb 4 report "contains a number of inaccuracies, including misquotes that were incorrectly attributed to representatives from the California Department of Health Services, and inaccurate information about possible contaminants in BotanicLab products."
We acknowledge and have apologized for misattribution of one, strong phrase, "clean up their act," to a CHDS employee. This was sheer journalistic ineptitude. We're sorry too for failing to protect sources of accurate information at CDHC from keel-hauling.
We rebut Botaniclab's claim that our article contained "inaccurate information about possible contaminants in BotanicLab products." CHDS and BotanicLab agree, SPES has now been shown to contain Xanax. Actual levels of Xanax are, as we reported, now known to be higher than the two, preliminary dose levels that BotanicLab features in its recall notice. (It appears the company waited 10 days before writing the recall notice of January 28th).
BotanicLab has offered no evidence so far to cast doubt on the higher, CHDS levels for the Xanax in SPES. CHDS has not withdrawn or changed those numbers. It looks to us that BotanicLab is standing by numbers known now to be out of date and too low. This is not good. SPES users, who may need their doctors to help taper them off whatever amount of Xanax they may have ingested unknowingly while taking SPES.
Updated Index of Reports 1998-2002
UCSF Halts PC-SPES Trial, Finds DES Feb 1, 2002
Botaniclab Recalls Samples Sept 3 2001
BotanicLab,Inc. Posts Copy of FDA Test That Found No DES in PC SPES Aug 23 2001
Rocky Mountain Instrumental Laboratories Incorporated, Fort Collins, Colorado Report DES present | Letter 1 | Letter 2 |
Second Lab Finds Artificial Estrogen Profile in Samples of Herbal Supplement for Prostate Cancer BY JACQUIE STRAX August 22, 2001
PC SPES, One Man's Story BY BOB ANDERSON © Raleigh, N.C. July 19, 2001
PC SPES Puzzle July 16, 2001
Botaniclab CEO "Stands Firm" Against PC SPES Allegations: July 14 2001
Synthetic Estrogen (DES) Reported in 2 Samples of "Natural" Herbal Compound PC SPES July 14, 2001
No DES in Prostate Cancer Herbal Supplement, BotanicLab Vouches July 10, 2001
Turmoil Over Prostate Cancer Supplement -- Estrogen Added or Missing? July 9, 2001
Prostate Cancer Herbal Mixture Avoids Osteoporosis of Chemical Hormonal Blockade May 13, 2001
PC SPES, Herbal Compound, Lowers PSA in Men With Advanced Prostate Cancer, UCSF Study Finds: October 28, 2000
PC-SPES Effects on Patients With Androgen Dependent Prostate Cancer: May 20, 2000
PC-SPES Update The Herbal Therapy Lowers PSA in Men With Advanced Prostate Cancer, UCSF Study Shows: May 6 - July 9, 1999.
PC-SPES Contains Estrogen, Lowers Testosterone and PSA: November 26, 1998
Test Report, DiPaolo (1998)
Figure 3. Results of High-Performance Liquid Chromatography, Gas Chromatography, and Mass Spectrometry of PC-SPES and the Estrogens Estrone, Estradiol, and Diethylstilbestrol (DES).