Only the company, by then a defunct shell, pleaded no contest to a felony. The defendants were barred from the dietary supplement business in California and forced to pay nearly $500,000 in penalties.
In the telephone interview, Sophie Chen said that while she could not discuss details, she hoped that "truth and justice" would prevail and people would understand her side of the story. "In due time hopefully we will have more information out to the public, when my lawyer thinks it's time," Chen said. "I feel very badly because I would very much like to talk about it, but I can't."
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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A Weak Regulator
The policies that allowed BotanicLab to operate for five years with little government supervision are rooted in decades of political struggle in Washington. The FDA has intermittently tried to tighten rules on dietary supplements, only to be fought to a standstill by industry lobbyists.
The biggest of these battles occurred in the early 1990s. After more than 30 deaths and numerous illnesses were attributed to a contaminated supplement called L-tryptophan, the FDA proposed a broad crackdown on supplement makers.
That effort backfired.
Prodded by industry publicity, huge numbers of Americans became convinced the government was about to take away their vitamins. "It was Armageddon as far as we were concerned," recalled Annette Dickinson, president of the Council for Responsible Nutrition, a Washington group that represents many supplement makers.
Moved by public protests, Congress passed the Dietary Supplement Health and Education Act of 1994. Supplement makers hailed the arrival of an era of "health freedom."
Drugs, the most stringently regulated category of consumer goods, must be proven safe and effective by their manufacturers before they can be put on the market. The 1994 law effectively prohibited the FDA from applying a similar standard to dietary supplements, even though they are often billed on the Internet and in store pamphlets as treatments for disease.
The FDA does have the power to ban some supplements if it can show "a significant or unreasonable risk of illness or injury." However, the burden of proof falls not on manufacturers to prove supplements are safe, but on the FDA to prove they're dangerous. Industry groups say that's a reasonable standard for a category of products that includes vitamins and minerals people have used for generations. Consumer groups contend that with 29,000 products on the market, the law effectively paralyzes the FDA.
"People cannot assume the FDA is minding the store, because it's not," said Marion Nestle, a nutritionist at New York University who has long followed the issue. "It can't. And they can't blame the FDA because Congress took away the ability of the FDA to do that."
The FDA's field force of inspectors, whose main job is to safeguard the food supply, in recent years conducted roughly 100 inspections a year to police the dietary supplement industry. The agency plans about 300 inspections this year. Susan Walker, who has held the job of enforcing supplement rules at the FDA for the past two years, said she was committed to "full implementation" of the 1994 law, including stricter manufacturing rules. "We are moving diligently, and we want to get it right," she said.
Others, meanwhile, are assessing their roles. Stephen E. Straus, director of the National Center for Complementary and Alternative Medicine, a unit of the National Institutes of Health that funded PC-SPES research, said that in the late 1990s, scientists held the "somewhat naive" view that the label on an herbal product was an accurate description of what was in the bottle. His agency didn't require detailed ingredient testing of herbal products in studies it funded. It is revising that policy, yet finding adulterants in a complex herbal mixture remains difficult.
"This is a substantial analytic problem that remains a work in evolution," Straus said.
Shattered Trust
In the civil suits claiming harm from BotanicLab products, numerous parties stand accused of aiding the company. Lawyers in the case have learned that Chen gave small amounts of company stock to collaborators she recruited at New York Medical College, where she held an unpaid adjunct faculty position, and they have asked whether that largesse tainted the scientists' judgment.
Several of the researchers in question have denied under oath that their judgment was altered, and the college itself has said it played little role in supervising Chen's work. She remains on the faculty there. "At no time has New York Medical College owned any interest in PC-SPES or its manufacturing or marketing entities, nor has it engaged in . . . distribution or marketing of the product," spokeswoman Donna E. Moriarty said in a written statement.
Milken's Prostate Cancer Foundation has also been sued. It has acknowledged awarding $150,000 in grants to Chen and another $500,000 to other researchers testing PC-SPES, but said these were small sums in a large research portfolio.
The victims' lawyers have turned up evidence that a Prostate Cancer Foundation executive traveled with Chen to China, that another published a paper with her, and that the group provided a venue for a conference on PC-SPES.
Leslie D. Michelson, chief executive of the foundation, said the group had done nothing wrong. "It's wonderful to look back with 20/20 hindsight and say 'you should have known' " about the product adulteration, he said. "Nobody did know."
The lawsuits could take years. Meanwhile, some people who took the products said their illusions about natural remedies have been shattered. One cost of the PC-SPES debacle, some families said, was that faith in the herbs kept some people from undergoing more conventional medical treatment that might have saved their lives. That may be the case with Murray Berk, the Long Island garment buyer. By the time PC-SPES was pulled from the market he had been on it for years, and his daughter said doctors advised them that the DES in the supplement had rendered his cancer resistant to more conventional treatment. He died last year.
"Giving people prescription drugs without their knowledge is insane," said his daughter, Shelley Martin, who once sold herbal products but has grown wary of them. "I just cannot believe it. It's total fraud."
A California woman named Tatiana Palma was one of the people who took BotanicLab products and is now suing.
She said she thought taking natural products would be safe and might help with her rheumatoid arthritis. But she and her husband, Charles Pell, now believe the pills contained prescription drugs that worsened several of her medical problems and caused a blind spot in one eye.
Sitting in a Santa Monica restaurant, she recently gazed toward a sunset over the Pacific Ocean and said she had learned a hard lesson. "The only herbs I am ever going to trust again," she said, "are the ones I grow in my own back yard."
