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Herbal Remedies Turn Deadly for Patients

Suits Fail to Bring Tougher Rules

By Justin Gillis
Washington Post Staff Writer
Sunday, September 5, 2004; Page A01

When a medical checkup indicated trouble with his prostate gland, John Meyer decided to try a natural remedy. Ignoring his wife's skepticism, the southern Arizona man went out and bought an herbal supplement promoting "prostate health."

Murray Berk, a Long Island garment buyer, did the same thing when he was diagnosed with prostate cancer. "I thought it was great there was a natural product available," said his daughter, Shelley Martin.

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)

The two men wound up taking the same herbal remedy, a substance called PC-SPES. Today both men are dead.

Their relatives blame the herbal supplement and the California company that made it. Batches of PC-SPES, it turned out, had been improperly mixed with pharmaceuticals, including an anti-inflammatory drug, an artificial estrogen considered so dangerous it was pulled from the market years ago, and a blood thinner that in high doses is used as rat poison.

The company, operating under the name BotanicLab, sold at least eight other herbal supplements that eventually proved to contain undisclosed prescription drugs. Those products are now off the market, and BotanicLab has closed. The company pleaded no contest to a felony charge for selling contaminated goods and three owners pleaded no contest to misdemeanor charges. Company executives declined to discuss the adulteration.

While BotanicLab may be history, the regulatory system that allowed the company to go into business with little oversight has not changed much. The government subjects herbal remedies to far less scrutiny than pharmaceuticals, a hands-off policy that has allowed the $20 billion supplement industry to flourish, growing to 1,000 manufacturers shipping 29,000 products.

Polls show most Americans think the products are safe and assume the government is testing them to be sure. In fact, strapped regulators at the Food and Drug Administration said they have typically conducted only 100 or so inspections a year, though they hope to step that up.

Congress mandated a light regulatory touch in the mid-1990s, after industry lobbyists stoked public concerns that the government was going to put new restrictions on common vitamins and natural remedies used for generations. Lawmakers have since begun to reassess that approach after the Food and Drug Administration last year moved to ban the use of the herbal stimulant ephedra and the bodybuilding supplement androstenedione in response to rising health concerns.

The BotanicLab disaster offers a detailed case study in how dangerous herbal remedies can be hyped on the Internet, embraced by desperate patients and legitimized by research institutions in ways that put lives at risk.

Many of the most exaggerated health claims about PC-SPES were made not on the bottle's label, where they would be subject to federal regulations, but on the Internet, where free-speech laws give people wide latitude to discuss the virtues and drawbacks of any issue. The glowing commentary apparently hit home with people reluctant to rely on traditional treatments, or for whom those had failed.

PC-SPES also gained popularity after some of the nation's premier cancer centers backed BotanicLab's flagship product and recommended it to patients. Top medical journals published studies touting the potential benefits of the remedy, studies they have yet to retract.

The adulteration was ultimately rooted out not by the major cancer centers endorsing PC-SPES, but by suspicious patients scraping up money to run their own tests.

Research on PC-SPES received critical financing from several outside sources, including $2.1 million in U.S. government money. Early funding also came from a prostate-cancer foundation created by Michael Milken, the convicted junk-bond financier who has become an influential voice in cancer politics in Washington.

Though BotanicLab shut down two years ago, new details about the disaster continue to emerge as a string of lawsuits in California and New York unfold against the company, its distributors and other parties.

Thirty-five people or their estates have come forward to claim harm, including men whose breasts grew so large they had to have them surgically removed, and others who inexplicably bled to death. Lawyers for the injured claim there may be hundreds of other victims in North America and Europe.

Whether any injuries can be linked to intentional adulteration remains to be seen. BotanicLab has at various times asserted that the adulteration of its products occurred among the Chinese suppliers of the raw ingredients and it should not be held responsible. Attorneys for the company and several defendants have also said in court that the purported victims are exaggerating their injuries.

This account of the BotanicLab saga is based on a review of more than 11,000 pages of documents that have surfaced during the legal action, and on interviews in Washington, New York and California. Newsday and several major newspapers reported some aspects of the story as it evolved, and significant details were first reported in the Cancer Letter, a Washington publication. Its editor, Paul Goldberg, and publisher, Kirsten Boyd Goldberg, made some of their files available.

David Markham, a San Diego attorney representing some victims in the case, estimated that BotanicLab may have taken in as much as $50 million before it was shut down.

"The big question," Markham said, "is why did it take five years for law enforcement in the United States to figure this out?"

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