A counterfeit version of Avastin, a widely used and expensive intravenous cancer drug. has according to the FDA been found in the U.S. It is unclear whether any of the bogus drug, which lacks any of the active ingredient, has been administered to patients.
It’s about time that drug counterfeiting received attention from the media; it is a significant public health menace. In 2010 during the H1N1 flu epidemic, the FDA warned consumers about a potentially harmful counterfeit anti-flu drug that could be a killer in two respects: It lacked any of the flu-preventing medicine it purported to be while it did contain an antibiotic similar to penicillin that can be lethal to certain people.
In that same year, counterfeits of the weight-loss drug Alli sold over the Internet contained none of the active ingredient in the real drug but did contain sibutramine, the prescription-strength weight-loss drug Meridia, which has since been removed from the U.S. market because of concerns about cardiac side effects.
These are not isolated incidents. It’s a bitter pill to swallow, but you can no longer be sure what will actually be in your next medicine vial. According to the World Health Organization’s estimates, it is thought that 10-15 percent of the world’s drug supply (and approximately half that much in the United States) is counterfeit.
Some products, such as the fake “generic Tamiflu,” are completely bogus. In dozens of drugs in the United States — including anti-HIV medicines, cholesterol-lowering agents, and anti-arthritis medications — dangerous substances have been substituted for the active ingredient.
More typical of Home Depot than Walgreen’s, the adulterants have included cement, gypsum, talcum powder, sawdust, industrial solvents and even yellow highway paint. Many other products have been tampered with, contaminated, diluted, repackaged or mislabeled in a way that misrepresents the contents, dosage, origin or expiration date.
Consumers who buy drugs abroad are taking an especially great risk. In one operation, spot-checks by the FDA and the U.S. Customs Service found that 88 percent of drugs imported into the country by mail or courier violated federal safety standards in some way.
Orders from Internet websites are especially vulnerable to fraud. An FDA operation in 2005 found that nearly half of the imported drugs intercepted by federal officials from four selected countries – India, Israel, Costa Rica, and Vanuatu – had been shipped to fill orders that consumers believed they were placing with Canadian pharmacies. Of the drugs being promoted as Canadian, 85 percent actually came from 27 other countries around the globe. A significant number of these products were found to be counterfeit.
The FDA has increased the number of its investigations of domestic counterfeiting (which can involve ingredients from abroad) several-fold during the past decade. The perpetrators include not only greedy businessmen trying to increase their profit margins, but also big-time organized crime entities, such as the Russian mafia, Chinese triads and Columbian drug cartels, as well as terrorist groups such as Hezbollah, the Irish Republican Army and Spain’s separatist organization ETA.
They are adept at duplicating the appearance of pills and capsules and even the security measures on the packaging, including serial numbers on the blister packs and holograms. Without actually performing sophisticated chemical or spectral analyses, the counterfeits may be virtually impossible to identify.
How do fraudulent medicines enter the drug supply? Primarily by counterfeiters’ taking advantage of an alternative to the mainstream pathway of pharmaceutical manufacturing and distribution through which drugs normally move linearly from manufacturer to distributor to pharmacy to patient.
What can be done?