Wednesday, August 25, 2010

Many drugs for U.S. kids tested in poor countries

From Reuters:
A law intended to speed up development of new drugs for U.S. kids has ended up financing clinical trials in poor countries, where the medicines might never become available.

That's the conclusion of a new report whose authors say the situation raises ethical concerns.

More than a third of the published trials performed under 1997 legislation called the Pediatric Exclusivity Provision were carried out at least partly in developing or transitioning nations, such as Uganda and India, researchers found.

"The trend that we describe brings up some scientific and ethical problems," said Dr. Sara K. Pasquali, a pediatrician at Duke University Medical Center in Durham, North Carolina, whose findings appear in the journal Pediatrics.

"Oftentimes, access to a study may be the only access to medical care a family has," she said of trial participants in developing countries. Once the testing is done, however, it's unclear if effective drugs will be marketed in the country in question, and whether they will be affordable. ...more

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