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June 22, 2010

Drug Trials Abroad Keep Auditors Away

FDA logo We’ve seen manufacturing jobs, IT jobs, customer service jobs, and engineering jobs offshored.  We can now add prescription drug trials to that list. The New York Times reports:

Medical ethicists have worried for years about the growing share of new drugs whose human trials took place in foreign countries where federal auditors could not make sure patients were protected, but no one knew how big the potential problem was.

But according to a report by Daniel R. Levinson, the inspector general of the Department of Health and Human Services, 80 percent of the drugs approved for sale in 2008 had trials in foreign countries, and 78 percent of all subjects who participated in clinical trials were enrolled at foreign sites....

The report “highlights a very frightening and appalling situation,” said Representative Rosa DeLauro, Democrat of Connecticut. “By pursuing clinical trials in foreign countries with lower standards and where F.D.A. lacks oversight, the industry is seeking the path of least resistance toward lower costs and higher profits to the detriment of public health.”

Sure, testing the drugs in lower-income countries is cheaper, but how sure can we be that the trial subjects are giving informed consent when foreign drug trial laws are often weaker than U.S. laws?  And how easily can the FDA audit a foreign testing site to ensure that the trial followed all correct procedures? Not very easily. In fact, the Inspector General’s report found that the FDA was 16 times less likely to audit foreign sites than they were to audit a domestic site, partially due to the high cost of auditing foreign sites.  It’s crucial that the FDA be able to verify that proper clinical procedures are followed. Otherwise, drugs that are unsafe or ineffective could be put on the U.S. market, endangering people’s lives.

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Comments

Don Juan of Austria


This is the kind of thing that would have been an outrage 20-50 years ago, with lots of (possibly appropriate) connections drawn to the Nazis and things like the Tuskegee experiments.

Nowadays, no one cares. I get the feeling too many Americans are going to be indifferent to even secretly happy if our drugs are tested on other people first.

A lot of our trade problems can be traced to our corrupt corporations and their stooges in the economics profession, but I wonder if some are because we are not as noble a people as we were in the past.

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