BotanicLab Recalls Samples of Herbal Supplement After Second Lab Finds Diethylstilbestrol (DES)
BY JACQUIE STRAX ©
New York: PSA Rising, September 7, 2001. BotanicLab Inc., the Brea, CA herbal supplement manufacturer, e-mailed the PC SPES mailing list yesterday noting that "a reputable testing laboratory has reported that DES was in certain lots of PC SPES."
The recall came about after members of the list released a report from Rocky Mountain Instrumental Laboratories Incorporated, Fort Collins, Colorado. This is the second test in just over a month to identify a problem with the product. In July, a laboratory (not publicly identified) hired by a Connecticut prostate cancer patient and wife couple, David and Susan Domizi, found DES in some older lots of the product.
At this point two separate patient-commissioned tests contradict the FDA's. Was the FDA's less sensitive?
Dr. Sulik's assay 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.
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 (approximately) 1/10th pill, the FDA test was looking to find 0.0563 mg of DES.
If one pill contained that much DES (10 x .0563 mg = .563 mg), then one pill would contain what today is considered a reasonable low daily dose. But PC SPES is consumed at 6, 9 or 12 pills per day or more.
Any DES content falling within the range of the FDA test method would make for a dangerously high daily dose (especially if the herbs themselves contain estrogen).
The Colorado assay and the earlier one commisioned by the Domizis found a much milder, subtler picture. So far, the highest concentration of DES found in any capsule tested with this sensitivity has been about 150 micrograms. Some pills contained much less (the lack of consistency is marked, and troubling).
The chemical face of DES
DES, a cheap, artificial non-steroidal hormone. First produced in London in 1938, it is an endocrine disruptor. Absorbed into the body, it either mimics or blocks hormones and disrupts the body's normal functions. In men with prostate cancer it blocks production of testosterone, which hormonally dependent prostate cancer cells use as a fuel. Endocrine Disruptor FAQLike thalidomide, DES has a tragic history. Yet it does have medical value. See BC Cancer Agency: Diethylstilbestrol
As a cheap palliative treatment for advanced prostate cancer and a medical alternative to orchiectomy (removal of testicles), DES has been found medically usable only if the dose is stricly controlled and blood thinners or aspirin are taken along with it to avoid blood clots, pulmonary embolism and heart attack. Morever, although this does not affect men with prostate cancer -- from 1938 to 1971, DES, given to women to prevent miscarriages, not only did it not work, but many children born to mothers who took it developed genital cancer.
In the 1970s the FDA banned DES from human medical use outside of clinical trials. Urologists switched prostate cancer patients to a new synthetic method for blocking tesosterone -- the luteinising hormone-releasing hormone (LHRH) analogues (Lupron, Zoladex).
Even though it is carcinogenic, DES was widely used in animal feed as a growth promoter to put weight on poultry, cattle and sheep. Today EPA regulates DES disposal as a hazardous waste, requires special labeling to inform physicians of the risks associated with administering estrogens and has banned all use of diethylstilbestrol in food-producing animals. (niehs.nih.gov...archive of carcinogens).
Last week BotanicLab posted an FDA report of an August 2000 test, which found PC SPES contained no DES.
"There is no question that Diethylstilbestrol (DES) is present..."
By then a number of patients who had seen the Domizis' report had collected more sealed bottles of PC SPES, some recent and others about two years old and had hired the Colorado company. On August 21, Rocky Mountain's associate director, Patricia Sulik PhD, and Robert K. Lanz PhD said that their lab had found DES in some capsules.
"There is no question that Diethylstilbestrol (DES) is present in capsules from the lots indicated," Lanz and Sulik report. At the same time, they said, the amounts their analysis found are all below the detection level of the FDA's tests.
BotanicLab says it will investigate. The company has called on customers on the e-mail list to return sealed samples of the product lots that the laboratories tested. "The company will: follow the trail of these product lots from raw materials to final products; enlist scientists to answer questions as to whether a substance that mimics DES can evolve from the combination of any herbs used in PC SPES during the process of manufacturing. communicate with all interested parties, including PC SPES users, as the investigation proceeds," the letter says.
"We see this as a serious problem that needs investigating because DES has never been an ingredient formulated in the composition of PC SPES. Verification of this fact was published in The New England Journal of Medicine, September 1998; and certified in reports from the FDA, August 2000," BotanicLab said.
BotanicLab Recalls Two Lot Numbers; Consumer Calls for Third Party Umpire
The company is calling for customers to return unopened PC SPES product with seals intact from lots #5430125, exp. '06/'02, and #5436285, exp. '03/'00. "We will advise where the returned product should be sent within 48 hours. In exchange, the company will replace, free of charge, any product returned from the above-referenced lots with a bottle of the current product. No question has been raised about the presence of DES in product currently available."
"Clearly," the company letter says, "a shared resolution of this issue is important to us at BotanicLab, and to all concerned..."
Susan Domizi, wife of a Connecticut prostate cancer patient, in response called on the company to select a trusted, independent third party "to directly receive the samples from the patients, who would retain custody of the samples and provide sample splits for testing to whatever interested parties you approve."
Dr. Robert DiPaolo and Michael Gallo, PhD reported in the NEJM September 17, 1998 that they had found "potent" amounts of estrogen in PC SPES. On the basis of tests similar to those run by Rocky Mountain and the unnamed lab, they suggested that the estrogen came from one or more of eight herbs listed as ingredients. DiPaolo's team bought and tested Saw Palmetto and ginseng, two of the herbs, separately but found no comparable potent estrogen content in them.
That strengthened belief in a potent, previously unknown plant estrogen arising synergistically, out of interactions among several or all of the eight herbs in the mixture.
This July, David and Susan Domizi, concerned that new batches of product had no effect on testerone levels, were not producing side effects and might be a reason for rising PSA's, hired a laboratory to do a comparative analysis. The lab they hired (and which they still have not identified) found DES in the older samples and none in current product at that date. Rocky Mountain's report confirms the discrepancy.
PC SPES in bottles of sixty capsules sells for around a hundred dollars. Patients commonly take 6, 9 or 12 pills per day at a cost of $300 - $600 a month. For those who lack private insurance, VA or Medicare coverage, this is cheaper than Lupron or Zoladex. DES costs under twenty dollars a month's supply.
Botaniclab has not said whether it has contacted oncologists at UCSF and Dana Farber who are conducting randomized double-blind clinical trials comparing PC SPES with DES. PSA Rising knows of one patient with metastic prostate cancer who has been waiting for several weeks to reach the PSA level (ng/mL 5) to qualify for entry into the trial.
Dr. Eric Small at UCSF was away on vacation when we called him for comment. His associate, Dr. Rimy, hung up on a reporter, after saying that he could not say whether UCSF has done any preclinical tests on estrogen content of PC SPES.
Dr. Aaron Katz, Assistant Professor of Urology and Assistant Attending at Columbia-Presbyterian Medical Center Holistic Urology said in a brief phone interview that he no longer prescribes PC SPES, because of what he has heard about concerns among patients.
Read.pdf files:
Rocky Mountain Instrumental Laboratories Incorporated, Fort Collins, Colorado Report | Letter 1 | Letter 2 |
UPDATE: BotanicLab Urges Recall, Hires Agency to Check PC SPES Samples for "Packaging Integrity" BY JACQUIE STRAX Sept 7 9:40 PM
Earlier Reports and Commentary:
BotanicLab,Inc. Posts Copy of FDA Test That Found No DES in PC SPES Aug 23 2001
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 ...
