June 4, 2009
Pharmaceutical companies are increasingly turning to the practice of testing their drugs on Third World populations in order to keep costs down, according to a report by researchers from Duke University, titled Ethical and Scientific Implications of the Globalization of Clinical Research.
The practice has raised concerns over exploitation of vulnerable populations and the accuracy of research conducted in such conditions.
“We don’t want to imagine that lower-income countries are the clinical trial mill for higher-income countries,” said lead author Kevin A. Schulman.
The Duke researchers compared the prevalence of clinical drug trial “outsourcing” by looking at the locations of 300 studies published in three major medical journals in either 1995 or 2005. They found that the number of countries taking part in clinical trials had increased by more than 100 percent over the course of those 10 years.
This finding is consistent with information gathered from the FDA by researchers from the Tufts Center for the Study of Drug Development. Researchers found that between 1997 and 2007, the percentage of FDA-registered principal investigators based in the United States has decreased from 86 percent to 54 percent.
Tufts researcher Kenneth A. Getz said that drug companies are motivated primarily by the lower cost of conducting research in the Third World, as well as the increased ease of recruiting study participants who have never received certain drugs.
Yet the relatively low cost of recruiting participants in the Third World may present a problem in itself, the Duke researchers warned, with poor people being unduly swayed by the promise of large payments and free medical treatment. Such obvious incentives could convince people to disregard the risks of participating in drug trials.
The researchers also expressed concern that drugs might act differently in the bodies of people living in significantly different environments and with drastically different developmental histories than First World populations.
“There are issues with the interpretability of the findings” of outsourced studies, Glickman warned.
Sources for this story include: www.nytimes.com