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9-20-06

Youth and Education

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Safety info withheld from docs

A study conducted by Duke University called, "Peer-Reviewed Publication of Clinical Trials Completed for Pediatric Exclusivity," was published today in the "Journal of the American Medical Association" (JAMA).
A Forbes article on this topic, entitled, "Child Drug Safety Not Reaching Doctors," explains that "pediatric exclusivity" is "a congressionally mandated program [which] allows the U.S. Food and Drug Administration (FDA) to extend the period of time a drug company holds exclusive marketing rights to a drug if that manufacturer conducts safety tests on the drug’s use in children.... The pediatric exclusivity program was designed to increase knowledge about how children may react differently to commonly used drugs, such as antidepressants, anti-seizure medications and sedatives."

The results of the Duke study, however, show that only 45% of these pediatric drug studies were published, and that studies "with a positive labeling change were more likely to be published."

According to a JAMA summary of the Duke study, one of the conclusions drawn was that "the dissemination of these results in the peer-reviewed literature is limited."

This is particularly concerning in light of the recent revelations of the serious dangers of psychiatric drugs on children and adolescents, as well as adults.


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