Prostate Cancer Herbal Mix PC SPES Alleged to Contain Synthetic Estrogen (DES)


		Prostate Cancer Herbal Mix Alleged to Contain Synthetic Estrogen (DES) Samples Testing DES-Free Claimed Less Effective UPDATE Turmoil Over Prostate Cancer Supplement - Estrogen Added or Missing? July 9 2001 BY JACQUIE STRAX © July 8, 2001 -- Susan F. Domizi, founder-owner of SOURCE, Inc., a Connecticut micronutrients company, said Friday that some samples of PC SPES, an herbal compound sold to prostate cancer patients, contain the synthetic non-steroidal estrogen (female hormone) DES (diethylstilbestrol). Domizi hired a laboratory to test four batches of PC-SPES, she said, to see if the formula had been changed. A number of prostate cancer patients who take PC- SPES are complaining that their prostate specific antigen (PSA) is rising. PSA is a blood-test marker of prostate cancer and its progression. Patients have called Botaniclab, Inc., the manufacturer of PC-SPES, to ask if the formula has been changed. Ownership of Botaniclab has changed since manufacture of PC-SPES began there in 1996. Some members of a PC-SPES mailing list have asked whether any of the 8 herbs in the proprietary formula are now no longer obtainable from China. Debbie Alder, marketing director for Botaniclab, in a phone interview two weeks ago, said the FDA has already tested PC-SPES for DES, the synthetic hormone. "Our quality control is spotless," Alder said. There is "no lot to lot variation." Testing "for the footprint" has shown it to be the same, Alder said. Botaniclab is using "the same formula" and "the same herbs," Alder said. Domizi said late on Friday July 6, "I have just received a FAX from an independent commercial testing laboratory that I retained to test four different Lot numbers of PC-SPES." She refused to identify the laboratory until the full report is released to her. Domizi said she chose this company to do the tests "because it had the expensive 'standard' for DES and had successfully performed DES testing previously." She said the laboratory used Gas Chromatography Mass Spectrographic Analysis on all the samples. Domizi said two of the PC-SPES lot samples she submitted for tests are reported to contain DES. Both of these Lots were from the ÂeffectiveÂ days, she said (Lot #5430125, Exp. 6/2002 and Lot#5436285, Exp. 3/2000). The other two Lots samples are reported to contain no DES, she said. These are from a recent Lot, #5431106 Exp. 4/2003, and the current new batch Lot# 5431164, Exp. 6/2003, Domizi said. Domizi says that she has no commercial interest in PC-SPES. She says she does not "have any 'axe' to grind with Botaniclab," the manufacturers. "They have made no claims," Domizi said. "They have marketed 'A synergistic blend of high quality herbal extracts based on ancient Chinese remedy.' 'For Prostate Health'," she said, quoting from the label. Domizi is a member of the National Association of Equine Supplement Manufacturers and has been a liaison for the Association of American Feed Control Officials' Novel Ingredients Regulatory Framework Task Force. This committee, now called the Enforcement Strategy for Marketed Ingredients Working Group. regulates use of botanicals, herbs and other supplements in animal feed. Domizi founded Source, Inc. in 1975 in North Branford, Connecticut. Source, Inc. manufactures and sells supplements derived from seaweed and other snutrients for use by horses, dogs and humans. Source Inc. has more than 4,500 distributors across the US, Canada, and abroad (http://www.4source.com/). Domizi says she will ask a "noted" doctor to speak directly to the test laboratory to confirm the results that she has reported. The doctor, she says, will then report to an Internet list for PC-SPES users owned by Taras Wybaczynsky, president of Herbal Vistas, Inc. Domizi said Friday that in her opinion the DES found in the two samples of two different lots could not been a "natural" DES. "The laboratory informs me," she said, "that the test is specific for the synthetic DES molecule. DES was first synthesized in 1938. It is a man-made drug. Eventually, at least 270 companies have manufactured it." In 1998, Dr. Robert DiPaolo and Huayan Zhang of the Cancer Institute of New Jersey published an article in The New England Journal of Medicine to report that PC-SPES contains "plant estrogen" (phytoestrogen). Several of the herbs listed as ingredients in PC SPES are known to contain "weak," phytoestrogen. [PC-SPES Contains Estrogen: Lowers Testosterone and PSA]. "We measured the estrogenic activity of PC-SPES with transcriptional-activation assays in yeast and a biologic assay in mice," Di Paolo and team said. They reported that tests at their lab found organic estrogen but no traces of synethtic estrogen. "In complementary yeast assays, a 1:200 dilution of an ethanol extract of PC-SPES had estrogenic activity similar to that of 1 nM estradiol," DiPaolo said. "High-performance liquid chromatography, gas chromatography, and mass spectrometry showed that PC-SPES contains estrogenic organic compounds that are distinct from diethylstilbestrol, estrone, and estradiol." However, from their published article it is not clear whether DiPaulo's team ran any additonal test specific for synthetic estrogen, like the test Mrs. Domizi paid for. The PC SPES formula, privately held, comes from Taiwan but is named to appeal to Westerners - "PC" stands for prostate cancer; "SPES" is Latin for hope. The formula consists of extracts from eight Chinese herbs. PC-SPES is sold at health stores, by phone and mail order and over the Internet. Oncologists at Memorial Sloan Kettering Cancer Center and other major centers recommend PC-SPES to men with advanced, hormone refractory prostate cancer. Earlier this week, PSA Rising contacted leading health store distrubutors to find out more about patient complaints. A spokesperson for The Apothecary/Pathway International in Maryland (www.the-apothecary.com) said, "None of our customers have really complained about a change, but quite a few have called because they had seen reports on the internet or heard about those reports. BotanicLab has assured us they have the highest quality control and all batches were triple assayed." Paul Anderson at Roots & Sprouts in Chicago area said "All this controversy is ridiculous. We have well over 1000 customers taking PC-SPES with no noticable change in the results. I personally talk to 30 PC survivors on average each day. Maybe one or two are having problems but that is typical." Anderson cited a patient in Maine who started with a PSA of 5343. "Taking the same stuff some of these complainers are yelling about (same batch ), his PSA dropped in 120 days to ... 3.5 in 120 days. He should be under ground but he's thriving." Anderson said: "This entire controversy is a hoax as far as I'm concerned." A supplier in Holland, Peter den Boer at Medpro, said "We send PC-SPES all over Europe and we have not heard of any change of the results from PC Spes. None of our customers ... complain any change in the product." Eric Small MD at UCSF in a 1999 study paid for by the Association for the Cure of Cancer of the Prostate (CaP CURE) found that PC-SPES lowers both PSA and testosterone levels. He took this as an indication that PC-SPES may work like standard hormonal therapy. "We think PC-SPES is estrogen-like," Dr. Eric Small said. Side effects included impotence, lowered sex drive and breast and nipple tenderness. In men with hormone dependent disease, Small said, PC-SPES appeared to "mimic" estrogen. But, Small said last year when he announced his study results, there may be other active anti-cancer ingredients in the supplement, because it lowered PSA levels in men with hormone independent disease whose testosterone was already low. "We have proven that this has some activity," Small said. "The next step is to sort out if this is any different from estrogen." Background Estrogen was used often to treat prostate cancer in the 1940s through the mid 1980s. One serious problem is thrombosis and heart attack from estrogen's clotting action on the blood. In some parts of the world estrogen, in cheap generic forms, is still used to treat advanced prostate cancer, or is being retested at lower doses. Last year doctors in London, UK tested low-dose DES (stilboestrol, 1 mg/day) combined with hydrocortisone (40 mg/day)for patients with metastatic disease who progressed on hormone therapy with recurrent/worsening symptoms and an increase in prostate-specific antigen (PSA) level. To try to reduce incidence of thrombo-embolic events, patients took daily aspirin (75 mg/day). Out of 29 symptomatic patients, 24 had some relief lasting for a median of six months. Abstract of report in BJU Int 2000 Jun;85(9):1069-73 UCSF PC SPES "Medical Care & Info" page for patients on study. PC-SPES Effects on Patients With Androgen Dependent Prostate Cancer Fox-Chase March 1, 2000. PC-SPES UPDATE: Early Results of UCSF Phase II TriaL: Herbal Therapy Lowers PSA in Men With Advanced Prostate Cancer, Study Shows May 6-July 9, 1999 PC-SPES Contains Plant Estrogen November 26, 1998 Two sets of results from a New Jersey study of the herbal mixture PC-SPES show that it is strongly positive for estrogen. Riding the Rockies, by Damon Phinney "My response to the PC SPES is not typical by any means. It was very bad stuff for me...." September, 1999. Bilateral Orchiectomy, by Ric Masten Where were you PC SPES folks when I needed you? Well, at least I have found you now! Live and learn!

Prostate Cancer Herbal Mix Alleged to Contain Synthetic Estrogen (DES)

Samples Testing DES-Free Claimed Less Effective

UPDATE Turmoil Over Prostate Cancer Supplement - Estrogen Added or Missing? July 9 2001
BY JACQUIE STRAX ©
July 8, 2001 -- Susan F. Domizi, founder-owner of SOURCE, Inc., a Connecticut micronutrients company, said Friday that some samples of PC SPES, an herbal compound sold to prostate cancer patients, contain the synthetic non-steroidal estrogen (female hormone) DES (diethylstilbestrol).

Domizi hired a laboratory to test four batches of PC-SPES, she said, to see if the formula had been changed. A number of prostate cancer patients who take PC- SPES are complaining that their prostate specific antigen (PSA) is rising. PSA is a blood-test marker of prostate cancer and its progression. Patients have called Botaniclab, Inc., the manufacturer of PC-SPES, to ask if the formula has been changed. Ownership of Botaniclab has changed since manufacture of PC-SPES began there in 1996.

Some members of a PC-SPES mailing list have asked whether any of the 8 herbs in the proprietary formula are now no longer obtainable from China.

Debbie Alder, marketing director for Botaniclab, in a phone interview two weeks ago, said the FDA has already tested PC-SPES for DES, the synthetic hormone. "Our quality control is spotless," Alder said. There is "no lot to lot variation." Testing "for the footprint" has shown it to be the same, Alder said. Botaniclab is using "the same formula" and "the same herbs," Alder said.

Domizi said late on Friday July 6, "I have just received a FAX from an independent commercial testing laboratory that I retained to test four different Lot numbers of PC-SPES." She refused to identify the laboratory until the full report is released to her.

Domizi said she chose this company to do the tests "because it had the expensive 'standard' for DES and had successfully performed DES testing previously." She said the laboratory used Gas Chromatography Mass Spectrographic Analysis on all the samples.

Domizi said two of the PC-SPES lot samples she submitted for tests are reported to contain DES. Both of these Lots were from the ÂeffectiveÂ days, she said (Lot #5430125, Exp. 6/2002 and Lot#5436285, Exp. 3/2000).

The other two Lots samples are reported to contain no DES, she said. These are from a recent Lot, #5431106 Exp. 4/2003, and the current new batch Lot# 5431164, Exp. 6/2003, Domizi said.

Domizi says that she has no commercial interest in PC-SPES. She says she does not "have any 'axe' to grind with Botaniclab," the manufacturers.

"They have made no claims," Domizi said. "They have marketed 'A synergistic blend of high quality herbal extracts based on ancient Chinese remedy.' 'For Prostate Health'," she said, quoting from the label.

Domizi is a member of the National Association of Equine Supplement Manufacturers and has been a liaison for the Association of American Feed Control Officials' Novel Ingredients Regulatory Framework Task Force. This committee, now called the Enforcement Strategy for Marketed Ingredients Working Group. regulates use of botanicals, herbs and other supplements in animal feed.

Domizi founded Source, Inc. in 1975 in North Branford, Connecticut. Source, Inc. manufactures and sells supplements derived from seaweed and other snutrients for use by horses, dogs and humans. Source Inc. has more than 4,500 distributors across the US, Canada, and abroad (http://www.4source.com/).

Domizi says she will ask a "noted" doctor to speak directly to the test laboratory to confirm the results that she has reported. The doctor, she says, will then report to an Internet list for PC-SPES users owned by Taras Wybaczynsky, president of Herbal Vistas, Inc.

Domizi said Friday that in her opinion the DES found in the two samples of two different lots could not been a "natural" DES. "The laboratory informs me," she said, "that the test is specific for the synthetic DES molecule. DES was first synthesized in 1938. It is a man-made drug. Eventually, at least 270 companies have manufactured it."

In 1998, Dr. Robert DiPaolo and Huayan Zhang of the Cancer Institute of New Jersey published an article in The New England Journal of Medicine to report that PC-SPES contains "plant estrogen" (phytoestrogen). Several of the herbs listed as ingredients in PC SPES are known to contain "weak," phytoestrogen. [PC-SPES Contains Estrogen: Lowers Testosterone and PSA].

"We measured the estrogenic activity of PC-SPES with transcriptional-activation assays in yeast and a biologic assay in mice," Di Paolo and team said. They reported that tests at their lab found organic estrogen but no traces of synethtic estrogen.

"In complementary yeast assays, a 1:200 dilution of an ethanol extract of PC-SPES had estrogenic activity similar to that of 1 nM estradiol," DiPaolo said. "High-performance liquid chromatography, gas chromatography, and mass spectrometry showed that PC-SPES contains estrogenic organic compounds that are distinct from diethylstilbestrol, estrone, and estradiol."

However, from their published article it is not clear whether DiPaulo's team ran any additonal test specific for synthetic estrogen, like the test Mrs. Domizi paid for.

The PC SPES formula, privately held, comes from Taiwan but is named to appeal to Westerners - "PC" stands for prostate cancer; "SPES" is Latin for hope. The formula consists of extracts from eight Chinese herbs. PC-SPES is sold at health stores, by phone and mail order and over the Internet. Oncologists at Memorial Sloan Kettering Cancer Center and other major centers recommend PC-SPES to men with advanced, hormone refractory prostate cancer.

Earlier this week, PSA Rising contacted leading health store distrubutors to find out more about patient complaints.

A spokesperson for The Apothecary/Pathway International in Maryland (www.the-apothecary.com) said, "None of our customers have really complained about a change, but quite a few have called because they had seen reports on the internet or heard about those reports. BotanicLab has assured us they have the highest quality control and all batches were triple assayed."

Paul Anderson at Roots & Sprouts in Chicago area said "All this controversy is ridiculous. We have well over 1000 customers taking PC-SPES with no noticable change in the results. I personally talk to 30 PC survivors on average each day. Maybe one or two are having problems but that is typical." Anderson cited a patient in Maine who started with a PSA of 5343. "Taking the same stuff some of these complainers are yelling about (same batch ), his PSA dropped in 120 days to ... 3.5 in 120 days. He should be under ground but he's thriving." Anderson said: "This entire controversy is a hoax as far as I'm concerned."

A supplier in Holland, Peter den Boer at Medpro, said "We send PC-SPES all over Europe and we have not heard of any change of the results from PC Spes. None of our customers ... complain any change in the product."

Eric Small MD at UCSF in a 1999 study paid for by the Association for the Cure of Cancer of the Prostate (CaP CURE) found that PC-SPES lowers both PSA and testosterone levels. He took this as an indication that PC-SPES may work like standard hormonal therapy. "We think PC-SPES is estrogen-like," Dr. Eric Small said.

Side effects included impotence, lowered sex drive and breast and nipple tenderness. In men with hormone dependent disease, Small said, PC-SPES appeared to "mimic" estrogen. But, Small said last year when he announced his study results, there may be other active anti-cancer ingredients in the supplement, because it lowered PSA levels in men with hormone independent disease whose testosterone was already low. "We have proven that this has some activity," Small said. "The next step is to sort out if this is any different from estrogen."

Background

Estrogen was used often to treat prostate cancer in the 1940s through the mid 1980s. One serious problem is thrombosis and heart attack from estrogen's clotting action on the blood. In some parts of the world estrogen, in cheap generic forms, is still used to treat advanced prostate cancer, or is being retested at lower doses.

Last year doctors in London, UK tested low-dose DES (stilboestrol, 1 mg/day) combined with hydrocortisone (40 mg/day)for patients with metastatic disease who progressed on hormone therapy with recurrent/worsening symptoms and an increase in prostate-specific antigen (PSA) level. To try to reduce incidence of thrombo-embolic events, patients took daily aspirin (75 mg/day). Out of 29 symptomatic patients, 24 had some relief lasting for a median of six months. Abstract of report in BJU Int 2000 Jun;85(9):1069-73

UCSF PC SPES "Medical Care & Info" page for patients on study.

PC-SPES Effects on Patients With Androgen Dependent Prostate Cancer Fox-Chase March 1, 2000.

PC-SPES UPDATE: Early Results of UCSF Phase II TriaL: Herbal Therapy Lowers PSA in Men With Advanced Prostate Cancer, Study Shows May 6-July 9, 1999

PC-SPES Contains Plant Estrogen November 26, 1998 Two sets of results from a New Jersey study of the herbal mixture PC-SPES show that it is strongly positive for estrogen.

Riding the Rockies, by Damon Phinney "My response to the PC SPES is not typical by any means. It was very bad stuff for me...." September, 1999.

Bilateral Orchiectomy, by Ric Masten Where were you PC SPES folks when I needed you? Well, at least I have found you now! Live and learn!