US Pharmacopeia sets quality standards for drugs sold in the United States.
Spotting phonies. Even brand-name drugs you buy at the local pharmacy may pose dangers. Counterfeiting, says Hubbard, is extremely profitable and "a lot easier than selling narcotics. And you don't have to deal with a Colombian drug lord." The World Health Organization estimates that 10 percent of pharmaceuticals worldwide are counterfeit.
Sometimes, perceptive citizens must do their own detective work. Soclof, the Michigan allergist, had been taking half a pill of Lipitor daily to lower his cholesterol. In 2003, he picked up a refill and found that the pills wouldn't crack, no matter how hard he tried. "It used to break in half very easily," he says. He thought the sudden change was "really odd." A few days later he happened to see a newspaper article about counterfeit Lipitor being sold in pharmacies. Soclof called Pfizer, which manufactures Lipitor, and the FDA and was sent a FedEx envelope to return the suspect pills for testing. They were fake.
Like Soclof, customers are at a disadvantage when it comes to figuring out if the medications they get from their pharmacist or mail-order benefit plan are fakes. In many cases, counterfeiters imitate packaging of the legitimate company, as in the case of the fake OneTouch test strips. The fraud was discovered only because alert users clued in LifeScan Inc. of Milpitas, Calif., the company selling the strips, that they were getting odd results. At other times, counterfeiters mix real pills with fake (as in the case of the counterfeit Lipitor) or "uplabel," substituting 10-mg pills, say, for 40-mg ones.
Experts in counterfeiting suggest that patients examine pills and packaging when they get a new prescription and note if the medicine tastes different, dissolves differently, or appears to have different effects. "We're big advocates of going back to the pharmacy" where the prescription was filled if something looks off, says Ilisa Bernstein, director of pharmacy affairs for the FDA. A pharmacist can help answer questions: Often a pharmacy will switch a patient from one generic to another, and the difference in the pills' appearance can spark needless worry. If in doubt, Bernstein says, take the medicine back to the pharmacy, or call the manufacturer.
For years, federal agencies have warned Internet shoppers of the risks of getting bogus or substandard medication. Yet the Internet drug trade is still booming. In May, the FDA announced that patients who had bought Xenical, a weight-loss drug, over the Internet received pills that looked identical to the Roche product but contained talc and starch. Other pills contained Meridia, a different weight-loss drug. In a June survey by MarkMonitor, a San Francisco-based firm that keeps tabs on online sales and marketing abuses, 38 percent of spam E-mail hawking Internet drugs came from China; 24 percent came from the Russian Federation; and just 2 percent came from sites actually in Canada, though many others claimed to be based there. An online pharmacy that falsely claimed to be in Canada sold the tainted drugs that killed Marcia Bergeron, the Vancouver Island woman. The MarkMonitor survey found that just four of the 3,160 pharmacies surveyed were certified by the National Association of Boards of Pharmacy, which vets online drugstores.
Suspect supplements. If there are troubling gaps in the regulation of imported pharmaceuticals, the oversight of nutritional supplements has yawning cavities. More than 150 million Americans take vitamin and mineral supplements regularly, but those tablets don't always contain all of the active ingredient claimed. In June, the FDA issued rules defining good manufacturing practices for supplements. But manufacturers still aren't required to prove dietary supplements are safe and effective by testing them before they enter the marketplace, as they are with prescription drugs.
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