Oversea drug trials exploit and kill Third World poor and US consumers alike

by Tony Isaacs

(The Best Years in Life) 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.

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.

The drug industry refers to Third World trial recruits as “drug-naïve” patients 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 a medicine to 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 avoid FDA and other institutional scrutiny and sweep negative trial results - including deaths - under the rug in Third World 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 drug industry also has a phrase they coined for Third World drug trial countries: rescue countries. Thanks to an FDA loophole, drug companies whose domestic trials have not yielded favorable results can use the results they get in Third World 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-naïve” patients in Third World “rescue countries” is not fully known. However, numerous discoveries and reports of drug trial deaths, uninformed patients and other acts of abuse and deception leave no doubt that Third World 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 depended on Third World and other questionable trials.

Sources included:

http://douglassreport.com/2009/03/12/should-big-pharma-be-testing-drugs-overseas/
http://www.vanityfair.com/politics/features/2011/01/deadly-medicine-201101
http://cardiobrief.org/2010/12/02/vanity-fair-article-eviscerates-globalization-of-clinical-trials/
http://www.twnside.org.sg/title2/health.info/twninfohealth034.htm

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