Are Your Drugs Safe?

Shoddy and fraudulent pharmacy products pose a growing threat.

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By SHARE

Warning: The contents of your medicine cabinet may not be what they seem.

Just 10 of the 21 multivitamins tested met the quality claims on the label, ConsumerLab.com of White Plains, N.Y., reported in January. Several had significantly more or less of the active ingredients than promised; one was contaminated with lead.

Last fall, more than 1 million counterfeit OneTouch diabetes test strips flooded the United States and went on sale in 700 pharmacies in 35 states.

And in December, metal poisoning took the life of a 58-year-old woman who lived on Vancouver Island, Canada. Prescription medications she had purchased from an Internet pharmacy contained toxic amounts of aluminum.

"How is anybody supposed to know the difference?" asks Arthur Soclof, an allergist in Livonia, Mich. He discovered that the Lipitor he'd bought at his local pharmacy was fake only because the pills wouldn't break the way they had in the past. "If I wasn't splitting pills I wouldn't have thought twice about it," says Soclof, 50.

Gone are the days when Americans could unquestioningly trust in the quality and authenticity of their pharmaceuticals. So far, no American deaths have been linked to shoddy or fraudulent medications. But a surge in hazards discovered at home and abroad has cast new doubts on the safety of prescription and over-the-counter drugs, supplements, and other medical products. Americans "should be quite concerned," says Roger Williams, CEO of US Pharmacopeia, a private organization that creates the nation's official quality standards for drugs.

Americans still have the best pharmaceutical products in the world, says Williams. But the safety net is getting frayed. Recent problems with other goods imported from China, such as the melamine that tainted pet food and killed dozens of dogs and cats, and toothpaste made with diethylene glycol, have sparked worry that the pharmaceutical industry's rapid migration to manufacturing plants in China and other Asian countries is increasing the risk of similar problems with medicines.

Explosion of imports. In the past five years, Chinese pharmaceutical imports into the United States have more than doubled, to $698 million. Already, half of the aspirin used worldwide comes from China, as do 35 percent of the painkiller acetaminophen and almost all synthetic vitamin C. India's pharmaceutical imports into this country increased 2,400 percent, to $789 million, from 1996 to 2006, making it the fastest-growing drug importer. Last year, Indian firms won Food and Drug Administration approval to import more than 100 generic drugs, including a version of the anti-HIV drug Retrovir. India and China make about 20 percent of generic and over-the-counter drugs sold in the United States and at least half of the "active pharmaceutical ingredients" for pills made within the United States. "Ten years ago, the Chinese and Indian API market was nonexistent, and now they're dominant," says Lynne Jones Batshon, executive director of the Bulk Pharmaceuticals Task Force, a group of ingredient manufacturers. Price is a key driver of that shift, Batshon says, and complying with American regulatory requirements is expensive.

At the moment, consumers have no way of knowing where their drugs are produced or assembled, because there are no requirements for country-of-origin labeling of drugs. The counterfeit diabetes test strips were traced to a firm in Shanghai. And when at least 56 people died in Panama last fall after taking cough and allergy medicines, it was discovered that the drugs had been spiked with toxic diethylene glycol sold as harmless glycerin by a Chinese firm. Raw ingredients and finished products can move through a half-dozen countries before landing on a pharmacy shelf. Pharmacies buy from manufacturers or from wholesalers who are licensed by the states. "Our mantra is, the more often a product changes hands, the more likely a counterfeit can be introduced into the supply chain," says Rubie Mages, a former district attorney who is a director of global security for Pfizer, which makes Lipitor and Viagra, probably the world's most counterfeited drug.