Xanax, Warfarin and DES Found in Herbal Supplements
BY JACQUIE STRAX ©
New York: PSA Rising, February 5, 2002. BotanicLab, a supplement company in Brea, CA, is voluntarily recalling its herbal product SPES. California Department of Health Services (CDHS) has detected Xanax (generic name Alprazolam), a prescription anti-anxiety drug, in all samples of SPES that they have tested so far.
Yesterday, PSA Rising reported how BotanicLab has told its customers that testing by CDHS "found Alprazolam in two different lots of SPES." As we quoted, a section of the BotanicLab recall notice says, "The highest level found within one capsule was 0.123 mg."
This is what a BotanicLab hotline operator recited Monday when we asked to talk to company executives or the head of customer affairs. We were looking for more information. We already had the recall notice dated Jan 28, which a patient FAXed to us on request. Company representives were not available to answer questions from us at that time.
We called CDHS in Sacramento, CA. Unfortunately, we did some sloppy reporting. For one thing we reported that CDHS Food Scientist Dr. Richard Ko had said BotanicLab has been put on notice to "clean up its act."
Dr. Ko said no such thing and we are sorry for misreporting him. It is we who put it to Dr. Ko on Monday after he said, "They really need to do...." and then broke off. This is our own view and opinion. They really need to clean up their act.
Another problem involves the dose levels of Xanax cited in BotanicLab's voluntary recall notice, signed by President and CEO John Chen. As we stated, in this notice to SPES customers Chen says that "The highest level [of Xanax] found within one capsule was 0.123 mg." Chen says that SPES product labels recommend a dose of 2 SPES capsules in the morning, "and for additional benefit, another 2 capsules in the evening." He goes on:
If a user consumed the maximum recommended 4 capsules per day of this lot of SPES, the amount of Alprazolam [trade name Xanax] ingested per day would be 0.492 mg. This amount represents approximately 95 percent of the lowest daily dosage used in managing patients with anxiety, as recommended by the 2001 Edition of the Physician's Desk Refrence.
Numbers can act like fog. But when we raised this number 0.123 mg with Susan Bond, Food and Drug Section Chief at CDHS in Sacramento, she expressed surprise.
Here arose our communication problem. PSA Rising reported yesterday that Bond said that the Xanax level found in SPES was higher than 0.123 mg. "One result was 0.226 mg per capsule," Bond said, reading from her records. "Another lot was 0.274 mg."
Bond said the level found by the health inspectors would give a daily dose of "well over a milligram." This, she said, is significantly "more than a therapeutic dose," which can start "as low as 0.25 mg per day."
Anyone can look up the PDR and find that Xanax (Alprazolam) comes in tablet 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.
Bond did not say, though, as our report might have seemed to imply, that the State's higher test results are double what the company told its customers in the January 28th letter of recall. We stated that ourselves, and stick by it. A dose of 0.274 mg x 4 is 1.096 mg -- more than twice the dose that BotanicLab cites.
Tuesday, Ken August, spokesman for CDFS, threw more light by explaining to us, "Test results which came in after the recall, found higher levels." According to Ken August, when BotanicLab issued the recall, on January 28, only two test samples had been checked out.
So BotanicLab's numbers were accurate as far as they knew at that time. Yet even so, in our opinion, it may be wondered if there was a basis at that time for CEO John Chen's assurance about the lowness of the level of Xanax (Alpazolam) in SPES. Could he not have stated that these were the levels found so far? Could he not have made sure that all the test results were gathered before signing the recall notice? Speed is vital, but a company can send out an alert, advise customers that full details are on the way -- and avoid assurances based in incomplete information.
However, as Ken August and Susan Bond explained, it was CDHS that approved the recall notice that BotanicLab sent out on the basis of the incomplete data. Ken August emphasized this Tuesday.
We appreciate the CDHS's concern lest BotanicLab be misrepresented in this matter. Now that CDHS knows that the actual Xanax content was at least twice as much as the first two test results showed, we trust they will ask BotanicLab to update the information it's giving out to cancer patients. Let the State of California urge BotanicLab to amend their recall and send out another one.
Now to a final distortion in our report yesterday. Susan Bond mentioned Monday night that it was in response to consumer concern about DES in PC SPES that Sacramento looked closer at BotanicLab products. Concern about DES is what led to the discovery not only of Xanax in SPES but of the prescription blood thinner Warfarin (coumadin) in all of eight lots of PC SPES tested for it.
Susan Bond did not say or indicate or raise the possibility, however, that DES was or might have been in the eight lots of PC SPES that contained Warfarin. That's just part of what should concern the patient community -- a mere possibility, even a probability, given that three laboratories including now University of California San Francisco, had by then found DES in PC SPES.
It's a question -- if DES has ever been in the PC SPES product, why have tests by State of California and Federal Department of Agriculture never found a trace? I asked Bond about this Monday night and she said, "We went out to find it." But they found none. She added, "Sensitivity is very tricky on the testing. A very small amount is very active."
As reported last year, test thresholds for DES adopted and applied by CDHS and FDA are probably too high to capture the low levels found by other laboratories.
We hope the State of California will be a strong advocate for patient concerns about crisis at BotanicLab. For a start, people need to be told more about Xanax.
Minimized Xanax Warning
Xanax is a "downer," like all benzodiazepine class drugs. It depresses the central nervous system, which controls breathing. Xanax can make you drowsy while driving and should not be combined with alcohol. Xanax interacts with other central nervous system suppressants and with antihistamines, erythromycin and other drugs that cancer patients may need to take. Physicians' Desk Reference says Xanax interacts dangerously with ketoconazole (a drug regularly prescribed for advanced prostate cancer in the high dose form called HDK therapy).
Xanax can be habit forming and can cause both physical and psychological withdrawal symptoms. Stopping 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 not stop suddenly, you must taper off.
BotanicLab's recall notice says NOTHING about tapering or difficulty stopping. They do mention "drowsiness, light-headedness and dry mouth." But the point is, customers have been forced to stop abruptly. Surely people need to know symptoms they may develop now that the supply of SPES contaminated with Xanax has been shut down? The recall notice ought to carry as much information about Xanax as you find by law on the Xanax package insert.
Actually, that would be useful. Or is there a fear of stirring patients up to complain about lost beliefs in the purity of "holistic" therapies? Is there too much corporate flight from liability?
Dr. Sophie Chen last July said: "All the product in California, I stand by." She said she was working hard to make sure supply is met. She said she'd seen no evidence of any change of the formula or variation in samples. She said she welcomed inspection at BotanicLab. Even if the product may not be "perfect," she and her partners want to "work together" with the cancer community, she said. They hope to work in positive ways to learn more and gain better control of the product's potential to help patients.
Six months later, how much of this has come to pass? PC SPES and SPES are unobtainable. Yet from Dr. Small's and Dr. Oh's truncated trial, more is known about PC SPES's potential. Looks like PC SPES with lowdose DES works better against prostate cancer than higher dose DES alone.
To come back now to Dr. Richard Ko's view. "We are not opposed to alternative therapies," Ko said Monday night. "We strongly believe in patient choice and we don't want that to stop. We don't have the attitude of wanting to shut down a legitimate product." "There is," he added,"regulatory action we can pursue."
In China, Ko said, it can be "acceptable to use both Eastern and Western products." "But here we have a different regulatory system," he said. Problems arise "if a company, or their contractors, add in." "Be aware," Ko said, "it has to be labelled."
He could be speaking for cancer patients as well as for the state of California. Most cancer patients don't have time for a witchhunt. They do need strong and flexible advocates in the State of California and in D.C. to work for strict quality control, truth in advertising and freedom of information on behalf of informed choices.
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).