USA: Preocupa el "off-shoring" en investigación clínica

WASHINGTON — 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 is scheduled to be released publicly on Tuesday, but a copy was obtained by The New York Times.

Ten medicines approved in 2008 were tested entirely abroad with not a single test patient in the United States, the report said.

In many cases, foreign trials provide invaluable information proving that drugs are effective in a variety of ethnic groups. Mr. Levinson’s report found that most foreign clinical trial sites and subjects were in Western Europe, where ethical controls over research are generally as robust as those in the United States.

But the report found that Central and South America had the highest number of subjects per site and accounted for 26 percent of all subjects enrolled at foreign trial sites. In 2008, the Food and Drug Administration inspected 1.9 percent of domestic clinical trial sites, while just 0.7 percent of foreign clinical trial sites were similarly audited. Mr. Levinson’s investigators found that the F.D.A. was 16 times more likely to audit a domestic site than a foreign one.

Mr. Levinson pointed out that the agency was often unaware of foreign clinical trials as they were being conducted. As a result, federal regulators have no ability to ensure that patients in these trials are being protected while the research is continuing.
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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.” (Ver)

miércoles 30 de septiembre de 2009

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