Xanax, Warfarin and DES Found in "Herbal" Supplements
BY JACQUIE STRAX ©
New York: PSA Rising, February 4, 2002. Prescription drugs have been found lurking in two leading herbal supplements made by BotanicLab of Brea, CA. -- an artificial estrogen and a blood thinner in PC SPES and a tranquillizer in SPES.
We reported last summer and fall how two separate, patient-commissioned high-quality laboratory tests on PC SPES detected DES, a synthetic estrogen. By early January this year, two more tests at University of California San Francisco (UCSF) and at Dana-Farber Cancer Center in Boston also found DES in PC SPES. Dr. Small reported his finding to the National Cancer Institute and to the federal Food and Drug Administration (FDA), which oversees all cancer trials.
Mid-January, California state health authorities in Sacramento ran some tests. They did not find any DES, despite looking for it. Neither they nor the FDA ever have found DES in PC SPES..
But today, a California Health Department Services section chief said they had found the prescription blood thinner Warfarin in PC SPES. The Hy also found Xanax, a common prescription tranquillizer, in another BotanicLab product called, simply, SPES.
PC SPES, which is sold for "prostate health," is well-known to be active against prostate cancer. This has been demonstrated in vitro, in animal studies and in some clinical trials of human subjects. Many patients with recurrent or hormone refractory prostate cancer choose PC SPES ahead of or following hormonal blockades or chemotherapy. The product name, PC for "prostate cancer" and SPES from Latin for "hope," encourages optimism. For more than five years, if any one cancer therapy inspired user enthusiasm, it was PC SPES.
A handful of PC SPES skepticsand worriers it is true, spoke freely on patient-run mailing lists like the PC Help lists operated by survivor Don Cooley in San Diego. But it wasnot until last month that the saga began to unravel. Dr. Eric Small, urological oncologist at University of California San Francisco and Dr. William Oh at Dana Farber Cancer Center, Boston, shut down their randomized clinical trial comparing PC SPES and DES as therapies for advanced, hormone-refractory prostate cancer.
Patients taking PC SPES actually were doing better than those taking DES (an old, inexpensive estrogenic therapy). At the Chemotherapy Foundation Symposium in New York City last November, Dr. Oh showed a slide of tumor regression in a patient of Dr. Small's who took PC SPES. But subsequently, when Small's lab scientists analyzed the PC SPES, they discovered that it contained DES. The two doctors explained this to patients already enrolled and took them off-drug. According to one patient's relative, patients turned away after waiting to enter the trial got a different impression -- that the study was so successful, no more patients were needed.
Susan Bond, Section Chief at CDHS, told PSA Rising tonight that state health department inspectors, in response to consumer worries about DES in PC SPES, took a closer look at the product at the BotanicLab plant. Eight lots of PC SPES tested positive for Warfarin (prescription blood thinner), Bond said. Possibly, these lots contained DES also, although unlike the other three laboratories, California state health authority's have never found it. "Sensitivity is very tricky on the testing" (for DES), Bond said tonight. "A very small amount is very active."
Warfarin would tend to counteract any tendency to clotting problems brought on by addition of DES. But the presence of Warfarin is no less worrisome for that, since most patients taking PC SPES are advised by their doctors to take aspirin or even Warfarin to counteract clotting effects of (supposed phyto-) estrogen.
Xanax, which CDHS has found in SPES, can only add to the stew. Some patients with advanced prostate cancer add SPES as a backup if the disease stops responding to PC SPES. Others use SPES to treat cancer pain. All the SPES samples tested contained Xanax (Alprazolam), a drug for anxiety and panic disorder. Bond said this was the first time CDHS had ever tested SPES. The SPES inspection was unscheduled, she said. They went to the plant to examine PC SPES, and just decided to check SPES too.
Minimizing Xanax levels found
"The highest level [of Xanax] found within one capsule was 0.123 mg," a customer representative said today quoting directly from the company's recall notice. However, Susan Bond at CDHS told PSA Rising tonight that the Xanax level found in PC SPES was higher.
"One result was 0.226 mg per capsule," Bond said, reading from her records. "Another lot was 0.274 mg." This is double what the company told its customers on January 28th.
The SPES product label recommends a dose of 2 SPES capsules in the morning, "and for additional benefit, another 2 capsules in the evening." The company says that the recommended daily dose of SPES would yield no more than "0.492 mg." of Xanax. They say this is about "95 percent of the lowest daily dosage used in managing patients with anxiety," as recommended in Physicians' Desk Reference.
But Bond said the level found by the health inspectors would give a daily dose of "well over a milligram." She said this is "more than a therapeutic dose," which can start "as low as 0.25 mg per day."
Xanax (Alprazolam) comes in sizes from 0.25 mg to 2.0 mg. Xanax is prescribed in doses from .25 mg three times a day to up to 3 or 4 mg. daily total.
Xanax Warning
As a benzodiazepine class drug, Xanax depresses the central nervous system (which controls breathing). It is habit-forming and starts working at the first dose. It can make you drowsy while driving and should never be combined with alcohol. If you don't know you're on it, it's dangerous.
Xanax interacts with other central nervous system suppressants and with antihistamines, erythromycin and some other drugs that cancer patients may need to take. Xanax interacts dangerously with ketoconazole, a drug prescribed in high doses (HDK) for advanced prostate cancer.
Xanax can cause physical and psychological withdrawal symptoms. To stop suddenly can cause diarrhea, anxiety, depression, irritability, insomnia, confusion, hypersensitivity to pain, feelings of suspicion or distrust (paranoia), memory impairment, weight loss, blurred vision and/or seizures. Any of these can make it hard to stop taking the drug. You must taper off.
BotanicLab's recall notice says NOTHING about tapering off. They do mention "drowsiness, light-headedness and dry mouth" while on it. Patients who taking SPES are adviced to consult a doctor and discuss any withdrawal symptoms.
SPES's appeal grew in the 1990's after Dr. William Fair, a urologist at Memorial Sloan-Kettering Cancer Center, announced that he was taking it in his fught against colon cancer. Dr. Fair became an inspiring advocate not just of SPES and PC SPES but of any therapies that stand up to evidence, therapies using the best of East and West, old and new. Fair founded a holistic medicine center in Manhattan called Haelth (spelled in the Anglo-Saxon way). He died of colon cancer a few weeks ago.
Are all the positives and hope in PC SPES threatened by this fiasco? "We are not opposed to alternative therapies," CHDS's Food Scientist Dr. Richard Ko said tonight. "We strongly believe in patient choice and we don't want that to stop," Ko said. "We don't have the attitude of wanting to shut down a legitimate product," he said. "There is," he added, "regulatory action we can pursue."
In China, Ko said, it can be "acceptable to use both Eastern and Western products" together. "But here we have a different regulatory system." "Be aware," Ko said, "it has to be labelled." And problems arise, he stressed, "if a company, or their contractors, add in."
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).