The Need For Speed

When you buy a medication in the United States, you are assured that it has been tested, evaluated and approved by the Food and Drug Administration (FDA). But there's a catch. The testing may not have been done in the United States, and may not have been done according to FDA standards.

Since 1980, the FDA has allowed the testing of pharmaceuticals in foreign countries, and often allows the tests to be conducted according to the standards of the country of origin. This may be fine if the country is Great Britain or another of the major developed countries, but what if that country is Nigeria or an underdeveloped third-world country with little or no health care system, let alone testing standards.

The pharmaceutical industry has discovered that it is expensive to follow the standards set down by the FDA, so in many cases they have turned to other nations to speed testing and bring drugs to market faster. Why the need for speed? Is it an altruistic desire to help the sick. Not quite. It boils down to one thing; Money! According to the Washington Post, the pharmaceutical industry estimates that it costs $1.3 million in unrealized sales for each day that approval is delayed awaiting test results. That's dollars in the stockholder's pockets, and that's the bottom line in corporate America.

How do these companies find test subjects in other countries? They do it in two ways, first the countries market themselves to the industry, boldly advertising that they have test subjects available. Why would a country do this? Again, the answer is simple. Countries with overloaded healthcare systems look to the American research dollars to help provide the care they can't provide on their own. Then, although not confirmed, there are rumors of payoffs and kickbacks to certain individuals within many countries which make advertising their potential as test sites advantageous.

The second way is to find a country with an epidemic of the disease your drug is supposed to treat, and then volunteer to use the drug to help the people of that country. Desperate people will take desperate steps, and in this case, they may allow testing under less than optimal conditions, which could skew the test results and give a false impression to the FDA when the test results are used to apply for permission to market the drug in the United States. Whatever the reason, pharmaceutical companies jump at the chance. Large groups of subject allows for faster testing, but it allows for other things as well. Next Week Part 2 of this article will explore those possibilities.

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