Colorado Lab Confirms Diethylstilbestrol (DES) in Prostate Cancer Herbal Supplement
"No Question," Lab Directors Say
BY JACQUELINE STRAX
New York: PSA Rising, September 4, 2001. A report by a Colorado laboratory released last night by members of the PC-SPES mailing list confirms a problem with the herbal supplement PC SPES. Although some samples that were tested showed no Diethylstilbestrol (DES), some samples were found to contain measurable amounts.
The chemical face of DES
Two separate privately commissioned tests contradict the FDA's. How did these tests differ? Was the FDA's less sensitive than the other two?
Dr. Sulik at Rocky Mountain Instrumental Laboratories Incorporated says "lots #5430125 ... and lot #5438285 definitely contained Diethylstilbestrol (DES). The identity of DES was verified both by a library match to a standard reference spectrum from the NIST library, and retention time and spectral match to a known standard of DES run with the samples. The other three lots were not found to contain DES at levels detectable by this assay...."
What detection levels were used? Dr. Sulik, patient-hired, says the assay she used can detect 10 micrograms DES per 320 milligram capsule dissolved in 5 ml solvent. FDA used a test with a detection limit for DES of 0.0563 milligrams per ml.
Arithmetic, anyone? The Colorado lab put one capsule at a time (320 mg) into 5 ml solvent. The FDA put 500 mg of product into 15 ml solvent. This is roughly 1 pill per 10 ml or 1/10th pill per ml. In that roughly 1/10th pill, the FDA test was looking to find 0.0563 mg of DES.
If that much DES could be found in one pill (10 x .0563 mg = .563 mg), then one pill would contain what today is considered a reasonable "low dose" per day of DES. But PC SPES is consumed at 6, 9 or 12 pills per day or more!
No wonder FDA did not find DES -- any dose in the range their test could pick up would be highly dangerous. Men on DES used to die of heart attacks taking 5 mg grams a day.
The Colorado assay and the earlier one commissioned by Susan and David Domizi found a milder picture. The highest concentration of DES in any capsule tested so far with this degree of sensitivity appears to be around 150 micrograms. At that rate, six capsules a day would yield up to 1 mg of artificial estrogen.
That dose might put a solid, effective "groundplat" beneath any remedy for prostate cancer.
Dr. Sophie Chen, co-holder of a patent for the PC SPES compound, has denied any possibility of presence of DES, a synthetic substance, in the herbal mixture she invented and first used in Taiwan. PC SPES is made in Brea, California by BotanicLab, Inc. from herbs imported from China. Last week, BotanicLab Inc. posted a copy of an FDA test that found no DES in PC SPES (Aug 23 2001).
"Recently," BotanicLab's notice says, "allegations have been made that PC SPES contains DES (diethylstilbestrol and diethylstilbestrol dipropionates). We have consistently stated that the allegation is untrue. We direct your attention to the relevant portion of a report from the FDA laboratory dated August 3, 2000 (lot # of PC SPES 5430171). The test results clearly stated 'No diethylstilbestrol and diethylstilbestrol dipropionate was detected.'"
Patricia Sulik PhD and Robert K. Lanz PhD of Rocky Mountain Instrumental Laboratories Incorporated, Fort Collins, Colorado, who tested samples from sealed bottles owned by patients, stated to the contrary on August 22: "There is no question that Diethylstilbestrol (DES) is present in capsules from the lots indicated."
DES, a cheap synthetic form of estrogen (the female hormone), at one time was used to treat prostate cancer. At the relatively high doses prescribed in the 1940s and 50s it raised risk of blood clots and caused a high rate of heart attacks. Even worse tragedies occurred when doctors prescribed DES to pregnant women, hoping to prevent miscarriage. The drug increased the risk of cancer in, especially, daughters of the mothers who took it. Like thalidomide, DES became an outlaw drug.
Today, the limit of detection for diethylstilbestrol (DES) is extremely low. High Performance Liquid Chromatography (HPLC) and Gas Chromatography-Mass Spectrometry (GC-MS) can detect this artificial estrogen at 0.1 to 0.2 parts per billion. [Multi residue method using coupled-column HPLC and GC-MS for the determination of anabolic compounds in samples of urine.]. The assays used by Food and Drug Administration (FDA) appear to be set too high to detect amounts of DES as small as those which Rocky Mountain Instrumental Laboratories Incorporated states that its assay found.
Estrogen was first discovered in PC SPES by means of the HPLC and GC-MS in 1998. A New Jersey doctor believed that patients of his who were using PC SPES at that time showed DES-like side effects. But when the test was run, researchers found that the estrogen "peak" was different "from the peak representing diethylstilbestrol." The PC SPES peak, they concluded, came from plant estrogens (phytoestrogens) in, presumably, some of the eight herbs that go into the compound.
But at times, for some men, those estrogen-like effects waxed and waned. This year, Susan Domizi, wife of prostate cancer survivor David Domizi, grew concerned to see that while he was on PC SPES he was losing the typical side effects -- and his PSA was rising. The Domizis hired a laboratory to see if current samples were as potent as the batches which till lately had worked for David. As reported on this site, Domizi announced July 8 that the lab she had hired had found DES in two samples of older PC SPES -- and no DES in samples from recent lots with no effect on her husband's PSA.
A number of men on the PC SPES e-list were just as concerned as were the Domizis. Patients submitted sealed bottles of PC SPES from different dates and lots. They included an unopened sample from one of two lots found positive for DES by the lab hired by the Domizis (which turns out to be Pacific Toxicology). Pooling funds, they selected a lab, Rocky Mountain Instrumental Laboratories Incorporated, Fort Collins, Colorado, that was prepared to go public.
Read.pdf files:
Earlier reports and commentary:
BotanicLab,Inc. Posts Copy of FDA Test That Found No DES in PC SPES Aug 23 2001 "Recently, allegation has been made that PC SPES contains DES (diethylstilbestrol and diethylstilbestrol dipropionates). We have consistently stated that ..." (Statement on BotanicLab website)
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). The results of high-performance liquid ...
