AEI suggests booting WHO drugmakers that don't meet the grade

Some companies making drugs for World Health Organization programs in Africa are manufacturing substandard products that can lead to resistance, two new studies find. To get a handle on the problem, the studies' author is recommending that the WHO institute a three strikes and you are out rule for companies that are churning out low-quality products.

The studies by the American Enterprise Institute, the conservative think tank that takes on economic issues, are published in Research and Reports in Tropical Medicine. The study's lead author, Roger Bate, has researched and written extensively on the issue of substandard drugs in Africa. In the most recent study, 2,652 malaria, tuberculosis and anti-bacterial drugs were bought off-the-shelf in low- and middle-income countries and then tested for quality. It found 13% of drugs that are not approved by a stringent regulatory authority or the World Health Organization failed quality tests. Of those drugs that the WHO had approved, 7% failed, and of those, 18% were made in China.

Bate, a resident scholar at the AEI, estimated that maybe half the failures were counterfeit drugs and the other half were just poorly made. Many drugs bought at the same locations were high-grade. "This suggests that shoddy manufacturing, as opposed to product degradation, is the more likely cause of these failures," Bate says.

In the other study, 8% of antimalarial drugs that were approved either by the WHO or a strict regulatory authority, and sold in Accra, Ghana, and Lagos, Nigeria, didn't have enough active ingredient to meet quality standards. None had too much active ingredient, suggesting again "systemic poor manufacturing practices," not chance, Bate says. And underdosing fuels drug resistance, the study points out.

While the WHO and others are buying high-quality drugs from makers that are closely regulated, the findings suggest that fake and low-quality products can still get into the supply chain, either from lack of oversight or criminal intent, Bate says.

Some companies have taken the watchdog responsibility on themselves. Merck KGaA and GlaxoSmithKline ($GSK) are trying a system in some African countries where consumers can text a code to check the legitimacy of the drug.

But Bate suggests that donors need to "step up post-market surveillance and increase penalties for repeat offenders." He says if a company's drugs fail quality testing three times in a year, it should lose its WHO prequalification status for all of its registered products. "If we took drug quality control as seriously in poor countries as we do in the West, we could save lives and dramatically increase the impact of our public health programs," he says.

- here's the release
- see the studies here and here