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Every year, 200,000 Americans die from prescription medication.  Now, Donald L. Barlett and James B. Steele of Vanity Fair magazine highlights another reason why American patients should pop their pills with caution.  The article reports that the pharmaceutical industry is increasingly seeking out poor foreign countries that have little regulation such as Bangladesh, Estonia, Tunisia, Romania and parts of China to conduct clinical trials for new drugs intended for U.S. markets.  
These foreign clinical trials have skyrocketed in popularity over the last decade.  According to the Department of Health and Human Services,  in 1990 only 271 clinical trials testing drugs intended for American consumers were performed in foreign countries.  By 2008, these foreign trials have risen almost 2,000% to 6,485.  This year alone, 80% of the applications received by the Food and Drug Administration were for drugs tested in poorly regulated countries.
In addition to lax regulations, it is cheaper to conduct trials and participants are easier to gather in these countries where the majority of participants survive on only a few dollars a day and are eager to be compensated.  Many trial participants are illiterate and do not understand the consent forms.  Some participants believe that they are actually being treated for a disease rather than possibly being given a placebo.  
Pfizer, the largest pharmaceutical manufacturer and twenty other top manufacturers, now conduct one-third of their clinical trials in foreign countries.  The Food and Drug Administration only reviews roughly 1% of domestic clinical trials – as for foreign clinical trials the FDA reviews less than 1%. 
At least one fatal drug called Ketek, an antibiotic used for respiratory tract infections, was approved by the FDA.  Ketek was developed by Aventis Pharmaceuticals, which is now Sanofi-Aventis, in the 1990s and tested primarily in Hungary, Morocco, Tunisia and Turkey.   Less than a month before the FDA approved Ketek as safe, American researcher Dr. Anne Kirkman-Campbell, was sentenced to 57 months in prison for falsifying 91% of her Ketek data.  Kirkman-Campbell even enrolled her own office staff to participate in the study.  Despite the falsified data, Ketek won approval by the FDA.  Less than a year after Ketek hit the market, 93 reports of severe adverse reactions such as liver damage were made to the FDA and 12 people died.  The FDA finally applied a black-box warning on Ketek restricting it’s use.
What prescription consumers in the U.S. need to be concerned about is the FDA approving drugs in which the data may be completely unreliable or falsified.  If the FDA is reviewing less than 1% of foreign trials, Americans have little assurance that these drugs are safe.

Read the article on deadly pharmaceuticals here

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