New York, NY -- Counterfeit drugs remain a real and growing threat to global health, jeopardizing the security of the American drug supply, according to an updated report by the American Council on Science and Health (ACSH).
The 2009 edition of the booklet Counterfeit Drugs: Coming to a Pharmacy Near You was released today, following peer review by a panel of top experts in the field. It documents how increasingly sophisticated counterfeiting rings, some with connections to organized crime and even terrorist groups, have improved upon their methods of evading international police and investigative forces, slipping 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, were 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 been shipped to pharmacies and dispensed to unwitting American consumers.
•As recently as this past year, the first episode of fatalities from tainted drugs in the United States came to light when almost 100 people died from contaminated heparin, imported from China. Of course, this number pales in comparison to the toll of counterfeit drugs in the less developed world.
•The risk of fake, adulterated medicine is even greater when drugs are purchased from unregulated online sites. Some of these, ostensibly "Canadian," have been found to actually be located in China and other poorly-regulated regions.
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 even the minimal 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.
What can individuals do to protect themselves? 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 ACSH report advises: "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." Read the updated ACSH report on Counterfeit Drugs here
The American Council on Science and Health is a public health, consumer-education consortium of over 350 scientists and physicians, experts who serve on ACSH's scientific advisory panel. ACSH publishes reports on issues pertaining to the environment, nutrition, pharmaceuticals, and tobacco and helps the public deal with the real health risks productively.
Dr. Elizabeth Whelan, ACSH President: whelanE[at]acsh.org (212-362-7044)
Dr. Gilbert Ross, ACSH Medical Director: rossG[at]acsh.org (212-362-7044)