The Myth Of 'Safe Drugs' From Abroad

July 03, 2009|By John Michael O'Brien

More than 150 years ago, Baltimore's port inspector saw Europe's poorest-quality drugs being dumped on the United States. He knew substandard medicines hurt soldiers abroad and wanted to defend citizens at home. Port inspectors, doctors and pharmacists demanded higher standards for drug safety. As a result, the United States has the safest drug use system in the world.

Sen. Barbara A. Mikulski and her colleagues on the Health, Education, Labor, and Pensions Committee recently defended drug safety and protected patients by demanding that any effort to obtain drugs from abroad have the secretary of health and human services' guarantee that it would protect patients and save money. Past Food and Drug Administration commissioners have claimed it can't be done, and state efforts to import drugs have failed to show savings while wasting millions of taxpayer dollars.

Apparently, some in Congress believe that counterfeit drugs are not a real problem - despite the fact that numerous reports suggest that the worldwide counterfeit-drug epidemic is a threat to the health and security of American consumers. According to Customs and Border Protection officials, seizures of counterfeit imports coming into the U.S. rose by 22 percent (and by 141 percent in value) during the first half of 2007. It is impossible to know if a Web site with a Canadian flag links to a Middle Eastern pharmacist selling drugs from Turkey or even Iraq. It is downright scary to know drugs being made with cement mixers can look so real that not even scientists can correctly pick out the drug their company safely makes under strict FDA oversight.

As a public health professional, I have seen the "laboratories" where chemicals stored in outdoor sheds are mixed in unsanitary conditions and made to look like drugs millions of Americans depend on to stay healthy. Organized criminals have discovered they can make more money selling counterfeit drugs than they can selling narcotics.

As a pharmacist, I have talked to medical professionals and drug quality experts in Asia, the Middle East and Africa who explain that half of the drugs in their countries are fake. Their pharmacists often have to resort to cumbersome test kits to detect drugs that are either poisons that kill immediately or fakes that kill eventually. It is impossible to expect U.S. regulators to approve drugs from abroad, and it is impossible to expect pharmacists to be sure drugs that leave the FDA's system are indeed safe.

Prescription drugs are the best value in health care, costing only 10 cents of every health care dollar. Unfortunately, the uninsured or even people with insurance have to pay full price or high co-payments out of their own pocket. The economic downturn has caused many Americans to skip preventive health services and not fill their prescriptions.

The current effort to make affordable, quality health care accessible to all Americans offers new hope at the pharmacy counter. America's drug makers' offer to give 50 percent discounts to people in Medicare's "doughnut hole" as a part of comprehensive reform is even more encouraging.

Senator Mikulski has become the Senate's voice on improving health quality through better medication use. She has supported helping vulnerable patients in Medicare and Medicaid work with a pharmacist to manage their medicines, avoid dangerous side effects and fight chronic diseases like high blood pressure, diabetes and asthma. She should be commended not only for these efforts but for her efforts to protect patients from dangerous imported drugs.

John Michael O'Brien is assistant professor of clinical and administrative sciences at College of Notre Dame of Maryland School of Pharmacy. His e-mail is

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