Over the past two decades, drug makers have increasingly shifted trials for drugs intended for the U.S. market to developing 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 developing trial participants and American drug users is likely horrendous.
Many have questioned how appropriate and ethical it is to testdrugsintended for the American market indeveloping countries. Duke University`s recent report, “Ethical and Scientific Implications of the Globalization of Clinical Research”, labeled developing country trials as scientifically questionable and morally inappropriate. The study noted that genetic and other population differences could renderresultsthat did not apply to the target population. The report also raised concerns over the rolemoneymight play in recruiting poor volunteers.
Lead study author Dr. Kevin A. Schulman said that such trials imply a kind of imperial exploitation of developing countries. “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 tothe FDAfor new drugs contained data from foreign clinical trials.
The actual numbers may be much worse because companies are not required to report all overseas studies and often list only a single study where the actual trials are conducted in numerous locations.
Thedrug industryrefers to developing country trial recruits as “drug-naivepatients” because they usually are not being treated for any condition nor taking any medications. Such patients are almost sure to yield better test results. The term could also apply to how uninformed the patients are. In many instances, patients are led to believe they are being given amedicineto help them and do not understand that it is experimental or that they may be getting a placebo. Consent may consist of only a thumbprint or scrawled “X”.
It is much easier to avoidFDAand other institutional scrutiny and sweep negative trial results – includingdeaths– under the rug in developing countries. In 2008, the FDA inspected only 0.7 percent of all overseas trial sites. That`s just 45 out of the 6,485 locations.
The drugindustryalso has a phrase they coined for developing countries used fordrug trials: rescue countries. Thanks to an FDA loophole,drugcompanies whose domestic trials have not yielded favorable results can use the results they get in developing country trials to “rescue” drugs, which otherwise might not have been approved.
Due to restricted press freedom and the ease of suppressing negative results, the true scope of the harm caused to “drug-naive patients” in developing “rescue countries” is not fully known. However, numerous discoveries and reports of drug trial deaths, uninformed patients and other acts ofabuseand deception leave no doubt that developing drug trial patients are being killed and abused. Ultimately, so are untold thousands of American patients who are killed or harmed by drugs whose approval has been based on questionable trials.