Pharmaceutical fakes

30 Jun 2008
Los Angeles Times
A team of international researchers bought anti-malaria drugs from pharmacies in six cities in Africa's malaria belt, tested the products and despaired.

More than a third of the alleged medicines flunked the field tests for clinical efficacy. And 48% of the drugs manufactured in Africa -- the best hope for affordable medicines for the poor -- failed the quality tests. The researchers couldn't determine whether the drugs were counterfeit, or old medicines that had been repackaged with new expiration dates, or legitimate pharmaceuticals that had lost some or all of their effectiveness through age or improper storage.

What is now clear, however, is that large numbers of African malaria patients are being victimized by the widespread distribution of bogus or substandard medications. Equally horrifying, the sale of these inappropriate or ineffective drugs is virtually guaranteed to increase the prevalence of drug-resistant malaria, which in turn will make it even harder for Africa to eliminate the scourge.

The research, published by the American Enterprise Institute, should set off alarms around the world. In 1999, at least 30 people died in Cambodia as a result of taking counterfeit drugs to treat malaria, according to the Centers for Disease Control and Prevention. A recent follow-up survey in Asia found that 32% of malaria drugs there failed quality tests. Yet the World Health Organization reports that half of its member countries have weak regulations or none at all to prevent pharmaceutical counterfeiting. India and China have been found to be producers of counterfeit drugs, some of which make their way to Europe and the United States. The Internet has proved a boon for purveyors of fake medicines, and some counterfeits have also found their way into pharmacies here.

But the percentage of duds among African anti-malarials spotlights the need for new levels of scrutiny, particularly as the United States gears up to spend an additional $5 billion through 2013 to combat malaria. Especially worrisome was the large number of single-drug malaria cures the researchers found for sale. Last year, the WHO got its members to agree not to produce or sell such "monotherapy" drugs because of the likelihood that they will both fail to cure the patient and favor the emergence of drug-resistant disease. Patients are supposed to be getting a more effective combination of two different drugs.

The lesson is that technologies (even miracle drugs) are only as effective as the social infrastructure needed to deliver them. We must ensure that the medicines being distributed in U.S.-funded malaria clinics are subjected to better quality controls than those in local African pharmacies. Beyond that, sustainable progress against disease will require building up local public health systems that will have to simultaneously work on HIV/AIDS, tuberculosis, malaria -- and counterfeit drugs.,0,2899703.story