April 15, 2004
More than one billion pills are sold in this country every year. Although data is scarce, it is believed that about one percent of the drugs are counterfeit. Counterfeit drugs can enter the drug supply when if the seller conceals the drugs' origin and purchasers accept without questions the sellers' products.
In the United States counterfeiters tend to target high volume, high cost drugs. Often, counterfeiters commingle the fake drugs with the real drugs. The counterfeiters are often so well funded and sophisticated that investigators for the pharmaceutical companies often cannot tell the difference. As a result, Food and Drug Administration (FDA) investigations into counterfeit drugs have jumped four fold from the 1990s to 2000.
Some recent examples:
- In 2002, thousands of vials of Procrit labeled as containing 40,000 units were found to contain only 2000 units; later that year, vials were found that contained only tap water.
- In 2003, counterfeit Lipitor capsules were found that tasted bitter, and were too large.
- In 2004, several Internet sites sold contraceptive patches that contained no active ingredient to unsuspecting consumers.
The problem is much worse in other parts of the world. Reportedly, an estimated 10 percent to 50 percent of prescription drugs in Asia, Africa and South America are counterfeit. The problem is so bad in India that the Indian Parliament is expected to pass a bill authorizing the death penalty for drug counterfeiters.
It will take time for the U.S. drugs supply to be secured effectively. But physicians and patients can take some immediate steps to minimize the risk. The FDA is creating a counterfeit alert network while more doctors are telling patients to contact them if they have any unusual reactions or side effects or if a drug appears, tastes or smells abnormal.
Source: Paul M. Rudolf and Ilisa B.G. Bernstein, "Counterfeit Drugs," New England Journal of Medicine, April 1, 2004.
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