Early Promise
The scientific brain behind BotanicLab was Sophie Chen, an immigrant from Taiwan who went to college in the United States and then pursued a conventional career in chemistry, working at several large drug companies. In the early 1990s, she struck out on her own, telling people she wanted to try to marry Western medicine with Chinese herbal remedies.
Her scientific collaborator was Xuhui "Allan" Wang, an herbalist who liked to tell people he was a descendant of the doctor who served the last emperor of China. As Chen told the tale, the pair drew on the ancient wisdom of Chinese herbologists to combine Asian and a few American herbs into proprietary mixtures to treat conditions like prostate cancer, arthritis and others. They won U.S. patents on at least two blends.
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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The remedies became the core products of International Medical Research Inc., which did business under the name BotanicLab. Chen and associates in California, including her brother John Chen, set up the company in the Los Angeles suburb of Brea. Their timing was good: American interest in alternative medicine was rising in the 1990s.
What's more, the products could be put on the market relatively quickly. The herbal supplements did not have to undergo tests in humans because the company was not promoting them on the label as treatments for specific diseases.
Instead, the labels on various remedies touted support for "healthy joints" or offered "immune system enhancing properties." The Chens hit upon their biggest success with a supplement they called PC-SPES, labeled for "healthy prostate function."
Spes is the Latin word for hope, and the buzz on the Internet was that "PC" stood for prostate cancer. The product was billed as a combination of six Chinese herbs, one Chinese mushroom and an American herb.
PC-SPES showed early promise. Men with slow-growing prostate cancer pay close attention to the levels of a protein in their blood that may indicate whether their disease is spreading. Those who took the remedy reported that levels dropped sharply. True, it was quite expensive for an herbal remedy, as much as $500 a month, but many patients saw PC-SPES as worth it.
Chen told people she wanted to seek FDA approval to label the supplement as a prostate-cancer treatment, making it the nation's first formally sanctioned herbal remedy. That meant tests would be required, even though the product was already being sold in stores. Milken's prostate-cancer foundation provided Chen with two grants.
Other doctors launched small-scale studies. Then in 1998, the New England Journal of Medicine published a study led by Robert DiPaola, a researcher at the Cancer Institute of New Jersey, that suggested there really was something to the herbal formula. Leading institutions, including Johns Hopkins University, began gearing up for larger trials.
The National Center for Complementary and Alternative Medicine -- a unit of the National Institutes of Health, created at the behest of congressmen who support alternative medicine -- was looking for herbal remedies that might have some merit, and PC-SPES seemed like a top candidate. The agency began awarding grants.
BotanicLab's treatment was even featured in a 1999 book, "The Herbal Remedy for Prostate Cancer," by James Lewis Jr., a prostate cancer survivor and education professor who wrote several books about his personal battle and the disease. The book is still listed on Amazon.com's Web site, which features glowing reviews.
A Troublesome Mix
To all outward appearances BotanicLab was a roaring success by the year 2000. But behind the buff concrete walls and smoked-glass windows of the company's office in Brea, trouble was brewing.
The company was churning through a string of chief executives. One of these was a Harvard Business School graduate, Reed M. Benet, with special expertise in founding and expanding young natural-products companies. Hired in 2000, he said he was drawn by the company's sales growth of 40 percent a year and by the buzz he heard about BotanicLab's products and their promise against cancer. He said he was particularly impressed that the product was being tested in the laboratory of Eric Small, a top prostate-cancer researcher at the University of California at San Francisco.
Benet said he didn't entirely realize what he had taken on until he moved to Southern California. On one of his first days on the job, he said, he walked into a room where bulk herbs were stored and mixed. He found none of the paraphernalia of a modern company producing a consumer product -- no bar codes, no quality-control manual.
"It was a room full of boxes with mahogany-colored slats bound together with twisted wire, with Chinese letters on the boxes," Benet said in an interview in San Francisco, where he lives now. "Everything looked like it could have been carried in there by a camel 100 years ago on the spice road. I started realizing, 'Oh, my God -- what have I gotten myself into?' "
Benet said he went into the job knowing standards in producing nutritional products were less rigorous than those used in pharmaceuticals, but he still worried about the origin of the bulk herbs, which came from an array of Chinese suppliers. BotanicLab had bought a machine for its Brea site to help test product ingredients, but Benet said he could never get approval and funding to operate it.
Benet said that he advocated strict quality control and other measures, to no avail. After repeated clashes and growing doubts of his own, he said, he finally resigned in 2001.
Benet said he never saw anything at the company to suggest it was spiking its products with pharmaceuticals. But tests that the company itself ordered, after Benet left and the company came under pressure from California regulators in 2002, showed that bulk herbs coming into the country were free of pharmaceuticals, while packaged products leaving the Brea facility were adulterated with them. In addition, tests conducted after BotanicLab shut down have shown changes in the pharmaceutical ingredients over time that the people suing BotanicLab regard as evidence of a conscious effort to manage troublesome side effects.
Stephen H. Smith, a Los Angeles attorney representing multiple defendants, including the company, John Chen and Wang, pledged in an e-mail message on July 8 to answer queries about BotanicLab, but then failed to respond to multiple follow-up calls or to a set of written questions sent to him by fax and e-mail.
