As the number of clinical trials increases in developing countries like China, India, Mexico, and Brazil, the legal and ethical rules that would apply to such trials in the US or Europe are often missing, says the Guardian. Furthermore, the market for trials in developing nations is booming — in 2008, there were three times as many developing countries participating in FDA-registered clinical trials than there were in the entire period between 1948 and 2000, the Guardian says. The pharmaceutical industry likes the lower costs and the number of "treatment-naïve" patients, and the countries have the incentive of advanced medical science and drugs for people who couldn't otherwise afford them, the article adds. But the process of putting in place ethical and legal rules to protect study participants is often glossed over. At the 7th World Conference of Science Journalists in Qatar last week, the Guardian reports, Ames Dhai — director of the Steve Biko Centre for Bioethics at the University of Witwatersrand in South Africa — told meeting attendees that anticipated under-reporting of side effects and the lower risk of litigation make doing research in developing nations easier for drug companies. "The problem is implementing these [ethical] guidelines and the imperialistic attitude of researchers and sponsors who come to the country and frequently disregard our process," Dhai said. In places where illiteracy is common and questioning authority is rare, experts say the potential for ethical misconduct is plentiful, the Guardian adds.
Jul 06, 2011