Knockoffs on the Pharmacy Shelf
Counterfeit drugs are coming to America
It was a mystery. Over several weeks last winter, Massachusetts-based drug maker Serono Inc. received about a dozen calls from concerned patients using its AIDS drug Serostim. They complained of unusual reactions: itching, swelling, and rashes by the injection sites. The patients mailed their vials to the company for inspection, and soon after, Serono scientists discovered the cause of the ill effects: The drugs, which patients had bought at local pharmacies, were not Serostim at all, but fakes.
Counterfeit drugs have plagued underdeveloped countries for years. More than 7 percent of the world's pharmaceuticals are bogus, according to the World Health Organization; in Colombia, up to 40 percent of medications are believed to be fake. But until recently, a tightly controlled regulatory system has made it extraordinarily difficult for counterfeiters to slip suspect medications into the United States. Now, however, that system is straining under an explosion of Internet drug sales from overseas and increasingly sophisticated counterfeiting techniques.
Last month, vials of three counterfeit drugs made their way to pharmacy shelves in at least eight states. The drugs copied were Neupogen, an anti-infective manufactured by Amgen; Nutropin AQ, a human growth hormone made by Genentech; and a second batch of Serostim. This week, a New York drug wholesaler will be sentenced for distributing $4.1 million of other counterfeit medications, including the expensive fertility drugs Pergonal and Metrodin, as well as Eldepryl, a drug used to treat Parkinson's disease. According to the WHO, 16 percent of counterfeit drugs have the wrong ingredients, 17 percent have incorrect amounts of ingredients, and 60 percent have no active ingredients at all.
No one has yet quantified the counterfeit problem in the United States, but public-health officials consider it a growing threat. Pharmaceutical companies, loath to discuss the problem for fear of alarming the public or depressing sales, have quietly ratcheted up security. The Food and Drug Administration and U.S. Customs Service are stepping up enforcement. And a House oversight subcommittee will hold hearings this week. "Eventually," says one congressional investigator, "you are going to have an epidemic here that is going to kill people."
In fact, U.S. patients have already died from taking counterfeit drugs. And the tragedies highlight some flaws in a regulatory system designed to prevent them. In 1996 the FDA attributed several dozen deaths to a suspected counterfeit version of the popular antibiotic gentamicin sulfate.
Customs and FDA officials tracked the counterfeit to a New Jersey wholesaler called Flavine International. Company officials were convicted of importing counterfeit drugs from a pharmaceutical company in China and repackaging them to appear as though they had come from a manufacturer approved by the FDA.
Bad reaction. Two years later, gentamicin from the FDA-approved manufacturer caused six patients in a Denver hospital to suffer toxic reactions. Congressional investigators, who believe the drug was counterfeit, fault the FDA for not properly monitoring the manufacturer under its watch. Dr. Michael Earnest, a physician at the Denver Health Medical Center, who worked with FDA investigators, blames the agency for not alerting him to its findings. "I just assumed it was a manufacturing problem," Earnest said. "I did not know this [could have been] counterfeit." At the same time, health officials in other states say the FDA has failed to inform them of critical details of counterfeiting cases. And others fault the agency for not ordering a full recall of Eldepryl after that drug was counterfeited.
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