In two brief telephone interviews, Sophie Chen declined to discuss BotanicLab, the product adulteration or issues related to quality control in detail. But she did assert that she was not personally involved in mixing the company's products, saying she spent most of her time doing research in New York. She accepted no responsibility for the problems some patients now attribute to BotanicLab products. She said she pleaded no-contest to a criminal charge because she didn't have the money to fight it.
"I am just a scientist," Chen said. "I am only trying to find a cure for cancer."
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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Serious Side Effects
From the outset, doctors noticed that for an herbal remedy, PC-SPES had some odd properties.
Published studies showed that some of the men who took it got enlarged breasts, their nipples grew tender, their penises shrank, and they developed other problems. To some doctors, the side effects bore a curious similarity to the effects of another prostate cancer treatment: Users of PC-SPES showed signs of being on artificial estrogen therapy.
Prostate cancer arises in a male sex organ and grows under the influence of testosterone, the male hormone. It can therefore be suppressed, to a degree, by suppression of testosterone (a standard treatment today) or by administration of artificial forms of the female hormone, estrogen (an older, less popular form of treatment).
As part of his early study of PC-SPES, DiPaola, the New Jersey cancer doctor, tested the product for artificial estrogens. But any herbal mixture potentially contains thousands of chemical compounds, and analytical chemists said that finding an artificial drug among them can be difficult. DiPaola and his collaborators got results strongly suggesting an estrogen in the mix, but they couldn't figure out what it was.
The DiPaola group included the test results in their paper and urged caution in using PC-SPES, but in practice, it appears, other cancer doctors overlooked the lingering mystery and took the paper as a green light to recommend PC-SPES to their patients. DiPaola initially agreed to an interview about his testing of PC-SPES, but subsequently canceled it and declined to take questions; an aide said that administrators at his institution had ordered him not to talk because of the pending lawsuits.
Problems like enlarged breasts in men were strange but manageable. But then doctors began publishing comments in their studies about a more worrisome side effect: blood clotting. This, too, is a classic side effect of treatment with artificial estrogen, and a potentially deadly one. A clot in, say, a leg can break away and lodge in a vital organ, killing the patient.
JoAnne Meyer of Sonoita, Ariz., suspects PC-SPES caused the clot that killed her husband, John.
Meyer was a relatively healthy 64-year-old in 1998 when he learned he had an enlarged prostate gland. That's a benign condition, treatable with standard medical care, but John Meyer wanted to try natural remedies first. His wife had always scoffed at his interest in herbs, figuring he was wasting money, but she never imagined they would hurt him.
Though PC-SPES was mostly used by men with prostate cancer, it wasn't labeled that way, and Meyer apparently took the product's claims -- for "prostate health" -- at face value. Soon after starting the product, he contracted a serious leg problem that JoAnne Meyer now believes was a large blood clot. He was laid up for months, but felt well enough on Sept. 14, 1998, to try to get some yard work done while his wife was out.
"When I came back I found him dead over at the barn," Meyer said. An autopsy showed that blood clots had broken loose and lodged in his heart and lungs.
Echoes of Another Error
While PC-SPES was widely touted on the Internet, a few prostate-cancer patients who posted regular comments there were wary. In particular, some of them said in public postings, the side effects of PC-SPES struck them as resembling the side effects of a cheap artificial estrogen called diethylstilbestrol, better known as DES.
DES was at the center of one of the great medical disasters of the 20th century. The drug was given to pregnant women in the United States for three decades, beginning in the 1940s, to prevent miscarriages. Not only was it ineffective, later studies showed, but it caused cancer in the daughters of mothers who took it, and it caused genital abnormalities in both their daughters and sons. The drug was pulled from the market in 1971.
The drug was also tested as a prostate-cancer treatment, but it produced so many side effects, including blood clots, that most doctors concluded it would do more harm than good. It was largely discarded, but interest in it has cropped up from time to time because of scattered research showing it might work at low doses.
Public suspicions that PC-SPES might be contaminated with DES prompted the FDA's office in California to test the product in August 2000. But an e-mail from an FDA chemist that has come to light in the lawsuits showed that the agency used a protocol capable of detecting only high doses of DES, and none was found.
Elizabeth Keville, director of the FDA laboratory in California that conducted the test, said her scientists looked for relatively high levels of DES based on information they received from a consumer who had filed a complaint with the agency. If the scientists had known to look for lower levels, they would have conducted the test differently, she said.
"You've got to make certain assumptions" when running a test, Keville said. "We certainly would not have been looking at those higher levels had we been told it's trace contaminants. . . . When we look back, yes, perhaps things could have been done differently."
The FDA's failure to find DES became marketing fodder for BotanicLab, which posted the results on its Web site. Then, in 2001, some men noticed the PC-SPES suddenly stopped working for them -- levels of the indicator protein started rising to worrisome levels. Moreover, a few men taking the drug started to turn up in hospital emergency rooms, bleeding profusely beneath the skin and from various orifices -- the very opposite of the earlier blood clots.
