Thursday, April 19, 2012

Is Overseas Going Overboard?

Recently there has been a trend of drug research going overseas, purportedly to save money for increasingly tightening budgets.  However, recent cases have shown a perhaps darker incentive for going overseas, and that is looser FDA regulations.

One of the main issues that arise with overseas research is the lax monitoring of consent forms.  There are strict regulations within the United States to ensure that test subjects understand the trials and that they may be given placebos.  Oftentimes, though, when the trials occur overseas, people are not aware that they are being given placebos.  Instead, they believe that they are receiving actual treatment.

Another issue is the testing subjects themselves.  It is a generally held rule in the pharmaceutical research that the subject pool should have the drug available to them if it becomes FDA approved.  However, in many cases when the research happens overseas, they use indigent populations due to the low cost.  It is highly unlikely that the indigent population would have access to the drug once it became FDA approved.

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