Popping the Internet's Poison Pills; Counterfeit Drugs Are a Threat Even in the United States

Article excerpt

Byline: Dr. Henry I. Miller, SPECIAL TO THE WASHINGTON TIMES

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. …