The closure this month of BotanicLab, the company that manufactured the widely publicized PC-SPES herbal combination for prostate cancer, has outraged prostate cancer patients who view the product as a life-line when conventional treatments are exhausted.
But the anger is polarized, with some patients joining class action suits against the company, while others try to organize a new not-for-profit infrastructure for production of the proprietary botanical formula.
Late last year, the Brea, Calif.-based BotanicLab was forced to recall PC-SPES, after the California Department of Health Services found the product contained coumadin. Another BotanicLab product, SPES, also promoted for cancer treatment, was found to contain Xanax.
California authorities did not force BotanicLab to close, but required the company to prove its products were free of pharmaceutical contaminants.
BotanicLab president Barre Rohrbaugh claimed the warfarin was actually a phytocoumarin naturally occurring in one of the herbal components. The Xanax was blamed on contaminated herbs from China. After repeated promises to reintroduce “clean” PC SPES, the company told patients and distributors that as of June 1, it would discontinue operations completely.
The announcement met with extreme dismay among prostate cancer patients. Holistic Primary Care queried support group websites, and received numerous testimonials on the efficacy of PC-SPES in reducing PSA levels and improving quality of life. Patients, many of whom have advanced, hormone refractory cancer, fear that without the formula, their survival is jeopardized.
The coumadin discovery prompted two class action lawsuits in California, led by attorney Thomas Girardi, of “Erin Brockovich” fame. It also dead-stopped a clinical trial led by Eric Small, MD, of the department of urology, University of California, San Francisco. The product had previously shown significant benefit in reducing PSA in a trial by Aaron Katz, MD, at Columbia University. Another high-profile study was planned at Johns Hopkins, but this too has been aborted. To date, there are 43 papers on PC-SPES in major medical journals.
The coumadin findings jibe with a case report by Weinrobe and Montogomery (N Engl J Med. 2001; 345(16): 1213–4), of bleeding problems in PC-SPES users, including one death related to hemorrhage. This patient had measurable warfarin levels, though he had never taken warfarin.
Sophie Chen, PhD, the New York Medical College physical chemist and former pharmaceutical company scientist who developed both PC-SPES and SPES, would not comment on the situation, under advice from her attorney.
This is not the first time PC-SPES has been scrutinized for inclusion of low-level pharmaceuticals. In 2001, an independent analysis initiated by Susan Domizi, wife of a prostate cancer patient, led to discovery of diethylstilbestrol (DES) in older lots of the product. Ms. Domizi explained that for several years her husband’s cancer was well controlled by PC-SPES. But in June 2000, his PSA began to climb. “We started to wonder if he was becoming refractory to PC-SPES.”
The alternative hypothesis was that something changed in the formula. Ms. Domizi, who said she has no current or prior relationships with BotanicLab, posted queries on support group sites asking whether others who’d previously had success were having recurrences. She received dozens of similar stories.
Ms. Domizi, who owns Source, a Connecticut company that extracts nutrients from seaweeds, was familiar with analytical chemistry. She collected batch numbers and expiration dates from men experiencing recurrences, and saw a pattern: recent lots appeared to be less effective than older lots. She obtained two sealed bottles of “older” lot PC-SPES, and sent them with two sealed “new” bottles, to Pacific Toxicology Laboratories, a California forensic toxicology lab.
The chemistry was disturbing: the older bottles contained trace amounts of DES—one of the oldest therapies for prostate cancer, which fell out of favor due to its propensity to cause blood clots. The new bottles did not.
In a late-breaking session at the recent meeting of the American Society of Clinical Oncology, Dr. Robert A. Nagourney, director of the Rational Therapeutics Cancer Evaluation Center, Long Beach, CA, presented an analysis initiated by him at independent toxicology labs in the Czech Republic. They found indomethacin levels on the order of 1.07–13.19 µg/g, and DES levels as high as 159.3 µg/g, in PC-SPES lots made from 1996 to 1999.
Some patient advocates of PC-SPES question not only the validity of these findings, but also the motives of those initiating the tests. Sammy Bates, leader of the pc-spes@yahoogroups.com discussion group, and one of the most outspoken advocates for patients’ rights, sees a hatchet job initiated by a former PC-SPES distributor fired for trying to steal BotanicLab’s customer list.
He also challenged the credibility of Dr. Nagourney’s findings. “Who financed him and why? Can the trail of samples Nagourney used be properly audited? How certain are the results that DES and warfarin were there? How can we be sure one lab in a backward ex-Soviet satellite state can be trusted to produce information of the quality needed to condemn (the product) outright?” Echoing a view held by many, Glen Ethier, a Kirkland, WA, prostate cancer patient said, “The existence of a conspiracy (against BotanicLab) is easy to document, but nearly impossible to prove.”
Many users simply want the product back.
“The bottom line for us is, it does not matter if PC-SPES was made up of dried yak dung and aspirin,” said Mr. Bates. “It worked better than anything the pharmaceutical companies had come up with in fifty years. The fact that PC-SPES may have contained traces of DES or warfarin is academic. The agencies should realize that and make PC-SPES available on compassionate grounds.” To this end, some patient support websites, including the popular USTOO site (www.ustoo.com), are urging former users to write to congressmen, senators, and California regulators to push for immediate reintroduction of the product.
Critics, like prostate cancer patient Don Cooley, believe this is misguided. He urges fellow survivors to remember BotanicLab was not ordered shut by authorities. Secondly, reintroduction of the effective “older” PC-SPES would support a position that, “unknown prescription drugs should be allowed in an herbal product without the knowledge of patients.”
One PC-SPES user, Charles Reinwald, of Scarsdale, NY, is willing to take matters into his own hands. The retired attorney, and president of the non-profit Cancer Cure Coalition (www.cancercurecoalition.org), said if Dr. Chen will give him the formula for purely herbal PC-SPES, his group will finance new means of independent production. So far, she has not accepted the offer.
Mr. Reinwald, who chose to use PC-SPES instead of radiotherapy, said his motive is simple: to make the product available to the men who want it. In the mean time, he and others are scrambling to find nutraceutical substitutes.
Some report good results with Genistein Combined Polysaccharide (GCP), a soy derivative with documented anti-angiogenic properties, and Active Hexose Correlated Compound (AHCC), derived from Basidiomycetes mushrooms and shown to enhance the anti-cancer effects of chemotherapy and to strengthen immune function. Both products are regulated as pharmaceuticals in Japan, and distributed as nutraceuticals in the US by Quality of Life Labs, a subsidiary of Maypro Industries (www.Q-O-L.com).
Others are using various PC-SPES-like combinations, and some are taking botanicals but requesting prescriptions for low dose DES, in an effort to mimic the effects of “old” PC-SPES.
The rancor within the formerly unified prostate cancer community is saddening. Advocates of PC-SPES accuse critics of selfish ulterior motives or colaboration with a pharmaceutical industry conspiracy to destroy an efficacious alternative. Critics view advocates as dupes of an irresponsible manufacturer that knowingly laced an herbal formula with drugs hoping they would not be caught.
Mrs. Domizi, who agonized with her husband for several days before going public with her DES data, said simply,” It’s been a nightmare. There’s vicious dissent within the prostate cancer community. No good has come out of this.”
