Over the past two decades, drug makers have increasingly shifted trials for drugs intended for the U.S. market to Third World countries where it is easier and cheaper to recruit trial patients and where oversight is minimal. While outsourcing drug trials may save significant money for the pharmaceutical companies, the cost in human lives and suffering for both the Third World trial participants and American drug users is likely horrendous.
Many have questioned how appropriate and ethical it is to test drugs intended for the American market in Third World countries. Duke University’s recent report, “Ethical and Scientific Implications of the Globalization of Clinical Research,” labeled Third World trials as scientifically questionable and morally inappropriate. The study noted that genetic and other population differences could render results that did not apply to the target population. The report also raised concerns over the role money might play in recruiting poor volunteers.
Lead study author Dr. Kevin A. Schulman said that such trials imply a kind of imperial exploitation of the Third World. “We don’t want to imagine that lower-income countries are the clinical trial mill for higher-income countries,” Schulman said.
Until recent years, almost all of the drugs Americans took were tested primarily either in the United States or, to a lesser extent, in Europe. As recently as 1990, only 271 trials of drugs intended for American use were being conducted in foreign countries. By 2008, the number had risen to 6,485. According to a National Institutes of Health database, 58,788 such foreign trials have been conducted in 173 countries outside the United States since 2000. In 2008 alone, 80 percent of the applications submitted to the FDA for new drugs contained data from foreign clinical trials.
Lead study author Dr. Kevin A. Schulman said that such trials imply a kind of imperial exploitation of the Third World. “We don’t want to imagine that lower-income countries are the clinical trial mill for higher-income countries,” Schulman said.
Until recent years, almost all of the drugs Americans took were tested primarily either in the United States or, to a lesser extent, in Europe. As recently as 1990, only 271 trials of drugs intended for American use were being conducted in foreign countries. By 2008, the number had risen to 6,485. According to a National Institutes of Health database, 58,788 such foreign trials have been conducted in 173 countries outside the United States since 2000. In 2008 alone, 80 percent of the applications submitted to the FDA for new drugs contained data from foreign clinical trials.
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