Communicating over the Internet, patients tried to link various medical problems to specific batches of PC-SPES. One of the key figures in assembling this jigsaw puzzle was a Connecticut woman named Susan Domizi.
Her husband, David, had taken PC-SPES with good results. But it inexplicably stopped working for him in 2001, and she wanted to find out why. With a manufacturing background, she knew to ask about product lot numbers and quality control.
Siblings John and Sophie Chen were arraigned at an Orange County courthouse in 2003. They were eventually barred from the dietary supplement business in California and forced to pay nearly $500,000 in penalties.
(Helena Pasquerella via San Diego Union-Tribune)
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She decided to have various batches of the remedy tested for DES adulteration. The Domizis were vacationing at a family home on Maryland's Eastern Shore when she learned the results: The effective lots of PC-SPES had tested positive for DES adulteration at low levels, and the more recent, ineffective lots had tested negative.
Domizi knew she had to go public, but she feared the reaction, since PC-SPES had acquired a passionate following among men with prostate cancer.
"I didn't sleep for about 24 hours," she said. "I knew that any accusation would be greeted by the majority of men with horror and anger."
Added Evidence
She was right. Domizi posted her results, then linked up with men in California who paid for a second study, by Rocky Mountain Instrumental Laboratories, that confirmed her test. She was bombarded by e-mail, including death threats, from PC-SPES fans, but doctors couldn't ignore the accumulating evidence.
That October, a serious bleeding case came to public attention when two doctors working in Seattle, Mark Weinrobe and Bruce Montgomery, published a case report in the New England Journal of Medicine. Their patient, a traveling salesman, had turned up in an emergency room in Idaho bleeding from every orifice, and the hospital had barely saved him.
The state of California launched an investigation in January 2002 and eventually found DES in the same lot studied by the FDA. Meanwhile, Small, the University of California at San Francisco researcher who had been testing PC-SPES in patients, ordered separate tests in early 2002 that confirmed DES adulteration, and he halted a human study of PC-SPES. Soon afterward, the state announced that it also had found another drug, warfarin, in certain lots of the herbal supplement.
Warfarin, also known by the brand name Coumadin, is an exceedingly powerful blood thinner -- so powerful, in fact, that it was first developed and sold as rat poison. Rats that eat it bleed to death.
The drug is used in patients prone to clotting, but cautiously. It interacts with many other drugs, and taking aspirin with it can kill some people who are particularly sensitive.
The California health department ultimately forced a recall of PC-SPES and another product called SPES, billed as an "immune system enhancing formula." The latter was found to contain undeclared alprazolam, better known as Xanax, a powerful tranquilizer that can cause numerous side effects.
In the end, the state found adulteration with some pharmaceutical agent in every BotanicLab product that it could test, including several discontinued ones, and a laboratory in Switzerland also found contamination.
'Simply Too Sophisticated'
Robert Nagourney, a California cancer doctor who was originally a supporter of PC-SPES but grew wary as problems cropped up, conducted his own analytical tests, finally coming up with a definitive explanation for all the strange side effects the supplement had produced over the years.
His tests, on lots going back to 1996, showed the product had been spiked with low doses of DES and with an anti-inflammatory drug from the very beginning. The tests also suggested that after complaints about side effects began, someone repeatedly tweaked the PC-SPES formula, lowering the amount of DES, adding a less dangerous form of estrogen, and then eventually adding warfarin to the product in an attempt to counteract blood clotting from the estrogens.
"Obviously, some intelligent mind was orchestrating this thing," said Markham, one of the California lawyers suing BotanicLab and dozens of defendants accused of aiding the company. "This cocktail was simply too sophisticated."
Once the full scope of the product adulteration became known and the lawsuits began, BotanicLab shut down. Lawyers suing Sophie Chen have accused her of absconding with large sums, a charge she has denied.
Sophie Chen, John Chen, Xuhui Wang and the company itself were prosecuted in Orange County, Calif., accused of felonious conduct in selling dangerous products to the public.
But the state's case against them was circumstantial. A person close to the investigation, who would speak only on condition of anonymity because of the ongoing lawsuits, said the state had a relatively weak hand: no eyewitness testimony about who adulterated the products and no proof that BotanicLab had bought DES or other pharmaceuticals in bulk. At times BotanicLab has claimed that any product adulteration must have happened among bulk-herb suppliers in China. Moreover, this person said, the state got little help from the FDA and, at the time the criminal case was filed, had tests showing product adulteration only over a brief period.
In the end, the three individuals pleaded no contest to misdemeanor charges. All three said in court filings that they "had no preconceived design to injure other people."
