Counterfeit Drugs Threat to Global Health, Says New Report

See the updated 2009 version of this report by clicking here.

New York, NY – August 24, 2006. Counterfeit drugs are a real and growing threat to global health, and have even jeopardized the security of the American drug supply, according to a new report by the American Council on Science and Health (ACSH).

The report, Counterfeit Drugs: Coming to a Pharmacy Near You, released today following peer review by a panel of top experts in the field, documents how increasingly advanced counterfeiting rings, some with connections to organized crime and even terrorist groups, have gained the ability to slip potentially dangerous counterfeit, substandard and adulterated drugs into legitimate drug supplies, including that of the United States.

Counterfeit drugs, a term that includes fake, substandard, adulterated and mislabeled pharmaceuticals, are estimated by the World Health Organization to be about 10% of the global drug supply, and a much higher percentage in developing countries. For years, counterfeits have wreaked havoc in developing countries and have contributed to the increasing drug-resistance of diseases such as malaria, HIV/AIDS and tuberculosis.

Hundreds of thousands of these counterfeits have traveled through a network of secondary drug wholesalers and eventually been shipped to pharmacies and dispensed to unwitting American consumers.

Unregulated channels, such as online drug stores and drug importation, are particularly easy targets for counterfeiters. The FDA has no ability to control the safety of drugs purchased through these channels, and studies have found that as much as 88% of drugs being imported into the United States violate FDA safety standards and are potentially dangerous. Such importation is illegal under current law, but the FDA lacks the resources to stop the practice.

ACSH president Dr. Elizabeth Whelan warns that the legalization of drug importation, advocated by many in Congress as an easy way to obtain cheap drugs, "represents an unjustifiable breaching of our domestic drug supply that has the potential to erase all the gains we have made in the fight against counterfeit drugs."

Efforts to address the counterfeit problem through drug pedigrees, new anti-counterfeiting technology and increased licensing of wholesalers hold promise, but must be combined with aggressive enforcement.

According to ACSH's report, "the American consumer must be aware of the dangers posed by counterfeit drugs and be vigilant." Consumers should pay attention to the appearance and packaging of their prescription drugs for any unusual changes in shape, size or color, or sudden changes in the effectiveness of a medicine.

The report concludes, "Despite certain safety issues, prescription drugs bought from state-licensed pharmacies remain by far the safest choice available to consumers. Consumers should avoid imported drugs and those purchased from unregulated online drug stores, as these have a high risk of being substandard or counterfeit and could endanger your health."

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This report is available online at http://www.acsh.org/publications/pubID.1384/pub_detail.asp .

Contact: Molly Lee at leem@acsh.org or 212-362-7044, ext. 224.

The American Council on Science and Health is an independent, non-profit consumer education organization concerned with issues related to food, nutrition, chemicals, pharmaceuticals, lifestyle, the environment and health. For more information visit http://www.acsh.org or http://HealthFactsandFears.com