Monday, March 29, 2004

washingtonpost.com: Keeping Doctors in the Dark: "The British decision led to the FDA's move to hold a hearing on Feb. 2 in Washington. Until that time, of seven published studies of SSRI use for childhood depression, only three demonstrated positive effects as compared with placebos. At the meeting, doctors and patients learned that the FDA had eight additional drug company studies in its 'back files' that also showed no positive effects for the drugs but were never published. The drug companies had performed these studies under the 'pediatric rule,' which extended the patents of these medications for the companies by six months. But the companies were under no obligation to publish them, and so they languished in darkness until the British government's action made us aware of them.

At the meeting, even researchers and academic psychiatrists who were well-known proponents of psychiatric medication for children pleaded for transparency in research findings. How can doctors make sensible decisions when most of the studies are withheld from public scrutiny? The companies responded that the studies are proprietary company property and that publication of such data could hurt their product and stockholders."

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