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Despite recall, diet pill still selling in Hub

By Stephen Smith
Globe Staff / May 31, 2010

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Boston area doctors are sounding an alarm about the continued use of an over-the-counter diet pill recalled last year after federal tests detected contamination with a suspected cancer-causing chemical and traces of a powerful, potentially dangerous prescription drug.

Called pai you guo and made in China, it is touted as an all-natural, safe weight-loss panacea and remains available at some herbal supplement shops, beauty salons, and via the Internet, in a glistening yellow box depicting a reed-thin young woman beckoning. And despite warnings from the US Food and Drug Administration, it has maintained a grasp on dieters desperate to shed pounds swiftly, according to physicians and their patients.

“I’ve been shocked by the use,’’ said Dr. Pieter Cohen, a Cambridge Health Alliance internist who regularly encounters patients taking the capsules. “There’s word of mouth going around that these are very effective for weight loss and all natural. Most patients are horrified, surprised, alarmed when they learn that the FDA has already warned about this weight-loss pill.’’

The concerns about pai you guo underscore calls to better monitor and regulate pills, powders, and other products sold under the rubric of dietary supplements, a field that generates $24 billion in sales annually and counts 150 million Americans as users. It is an industry largely exempt from rigorous regulatory oversight, allowed to sell its goods without first receiving the FDA’s blessing on ingredients or safety.

Last week, an investigation conducted for Congress by the Government Accountability Office found that nearly all the herbal supplements tested contained traces of mercury, lead, or other heavy metals, and some carried pesticides. The metal levels were not considered dangerous, but some pesticide amounts exceeded acceptable limits.

In recent years, some supplement makers have been caught lacing their products with prescription medication in an apparent bid to make them more effective — but without alerting consumers, a practice that could pose significant health risks and that has sparked concerns among industry critics and trade groups alike.

“There’s been an epidemic, and epidemic is not an overstatement, of companies adding weight reduction drugs, adding erectile dysfunction drugs, adding diabetes drugs,’’ said Dr. Sidney Wolfe, director of the health research group at Public Citizen, a consumer watchdog group in Washington.

That seems to have been the case with pai you guo, which is also available as a tea.

An FDA spokeswoman said the agency tested the supplement after discovering it during a routine surveillance operation at a Los Angeles mail depot.

The results: Pai you guo contained sibutramine, an FDA-sanctioned appetite suppressant used in weight loss drugs, and phenolphthalein, a chemical once present in over-the-counter laxatives that is no longer approved for sale because of concerns that it might cause cancer. Although sibutramine continues to be sold in the United States as the key ingredient in the drug Meridia, a major study found that patients with a history of cardiovascular disease who took the medication had an elevated risk of heart attacks and strokes.

Last November, the FDA announced that the maker of pai you guo, GMP Herbal Products of California, was recalling the dietary supplement “due to the presence of undeclared drug ingredients.’’ Consumers were urged to destroy their supplies of pai you guo or return them to GMP.

“Any time you raise concerns about dietary supplements, obviously, all of the responsible industry suffers from the black cloud that now hangs over,’’ said Steve Mister, president of the Council for Responsible Nutrition a leading trade consortium. “These are prescription drugs out there masquerading as a dietary supplement and they are not.’’

Telephone messages left last week at a California number the FDA said belonged to GMP were not returned.

As recently as Friday, boxes of pai you guo remained on the shelf at the Dan Dan Herbal store along a bustling stretch of Allston. Employees of the tidy shop, where a sign on the window proclaims “Super slim,’’ said they were unaware of the recall but promised to remove the product, which sells for $20 for a month’s supply.

Siobhan DeLancey, an FDA spokeswoman, said in an e-mail that the federal agency “would be very interested in more detail about where consumers are obtaining these products and what lot numbers are on the packaging.’’

But for some dieters, the recall of pai you guo was more lure than rebuff.

Danielle Curio, a 30-year-old mother from Medford, was keen to lose weight that lingered after the birth of her second child a year and a half ago. A friend in her native Brazil told her about sibutramine, but Curio couldn’t afford it.

Then, one day at a beauty salon, she heard patrons raving about the pound-shedding prowess of pai you guo.

“I went online, I went to check the FDA, and I found out it had the medication in it,’’ Curio recalled. “That’s why I decided to start using it.’’

She began taking the pill at the end of March and has lost 10 to 15 pounds. Unlike when she took potent diet pills imported from Brazil — typically a brew of speed, tranquilizers, and other chemicals mixed into a capsule — the pai you guo caused no side effects, she said.

Dr. Brian Green, another Cambridge Health Alliance physician who has expressed worry about pai you guo, said some patients who use the pills report anxiety, depression, and nervousness. Neither he nor Cohen has seen patients with major complications related to pai you guo.

Still, Green said, there is no way to know the long-term consequences of using a supplement of uncertain provenance; most supplements are made overseas, with China leading the way. And patients with high blood pressure and other cardiovascular conditions are placing themselves at particular risk.

“I find myself saying to patients over and over again, ‘If we had a really good weight-loss medicine, you would know, and Americans wouldn’t look quite the way they look,’ ’’ Green said.

The supplement can carry another health threat: a distressing yo-yoing of weight.

It happened to Silvia Whitman. She tried Brazilian diet pills. She tried pai you guo. She stopped both because of health concerns. And, both times, the 40-year-old from Newton regained the weight she’d lost — and more.

“You can be sure you’re going to get it back twice over,’’ said Whitman, with a rueful laugh. “So shame on me.’’

Stephen Smith can be reached at stsmith@globe.com.

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