The economy might be in distress, but the snake-oil merchants are thriving. The Food and Drug Administration warned consumers recently about a potentially harmful counterfeited drug that could be a killer in two respects: It lacks all of the flu-preventing medicine it purports to have and it contains a drug that can be lethal.
The FDA had bought the product, billed as a generic version of Tamiflu, a drug that is used both to prevent and treat flu, without a prescription from a website claiming to be an online drugstore. (There is no FDA-approved generic version of the prescription product Tamiflu.) Tests conducted by the regulatory agency revealed that instead of Tamiflu's active ingredient, oseltamivir, the fraudulent product contains cloxacillin, an ingredient in the same class of antibiotics as penicillin. Thus, it is dangerous to patients who are allergic to penicillin, carrying the risk of a potentially life-threatening reaction called anaphylaxis, the symptoms of which include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness and a rapid and/or weak pulse.
Such occurrences are not isolated. It's a bitter pill to swallow, but you can no longer be sure what will actually be in your next medicine vial.
It is thought that 10 percent to 15 percent of the world's drug supply (and approximately half that much in the United States, according to World Health Organization estimate) is counterfeit.
Some products, such as the "generic Tamiflu," are completely fake: 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 a hardware store than a pharmacy, 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. In 2007, lethal Chinese-made diethylene glycol, mislabeled as nontoxic glycerin, was mixed into anti-fever medicines for children, killing at least 100 in Panama.
Consumers who buy drugs abroad are taking an especially great risk. In a 2003 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 those 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 sophisticated chemical or spectral analyses, the counterfeits may be virtually impossible to identify.
How do fraudulent medicines enter the drug supply? It happens 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. It also happens by unscrupulous middlemen providing toxic materials to legitimate, unwitting U.S. companies.
What can be done?
First, governments everywhere must increase the penalties for drug counterfeiting and for the sale of substandard products, even if it is inadvertent. Companies that import raw materials and intermediates must be held responsible for meticulous, compulsive quality-control testing of drug ingredients, intermediates and final products. If necessary, companies will need to find more expensive but more reliable sources of ingredients.
Second, regulators must more aggressively enforce regulations that require documentation of the "pedigree," or history, of a drug as it moves through distribution channels.
Third, we need to apply new track-and-trace and authentication technologies to identify and track the distribution of drugs uniquely.
Fourth, when making Internet purchases, consumers should patronize only pharmacies on the National Association of Boards of Pharmacy's recommended list .
Finally, consumers should be vigilant for anything amiss in any prescription drug obtained anywhere - unusual color, texture, markings or packaging and, when feasible, for any differences in effectiveness or side effects.
In order to ensure the safety and efficacy of medicines and confidence in commerce, governments and individuals must make combating the counterfeiting of drugs a high priority. As economist Roger Bate has written, "Until international bodies clean up their act and stop blurring the boundaries between safe medicines and substandard copies and until there are harsh local and international penalties for manufacturing and carrying counterfeits, the pirates will continue to get away with murder."
Dr. Henry I. Miller, a physician and fellow at Stanford University's Hoover Institution, was an official at the FDA from 1979 to 1994. His most recent book is "The Frankenfood Myth" (Praeger, 2004).
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