Antidepressant Makers Withhold Data on Children
By Shankar Vedantam
Washington Post Staff Writer
Thursday, January 29, 2004; Page A01
Makers of popular antidepressants such as Paxil, Zoloft and Effexor have refused to disclose the details of most clinical trials involving depressed children, denying doctors and parents crucial evidence as they weigh fresh fears that such medicines may cause some children to become suicidal.
The companies say the studies are trade secrets. Researchers familiar with the unpublished data said the majority of secret trials show that children taking the medicines did not get any better than children taking dummy pills.
Although the drug industry’s practice of suppressing data unfavorable to its products is legal, doctors and advocates say such secrecy distorts the scientific record.
“Conflicts of interest and the company control of the data have thrown out the scientific method,” said Vera Hassner Sharav, a critic of the drugs and a patients’ rights advocate. “If hundreds of trials don’t work out, they don’t publish them, they don’t talk about them.”
“We need a journal of negative findings,” agreed Darrel Regier, director of the American Psychiatric Association’s division of research, who believes the drugs save children’s lives. “The probability of those negative findings being published is far less than the chances of positive studies — — the companies. “They have a legitimate right to do what they want with the data,” he said.
But David Healy, a Welsh psychiatrist and author of “The Antidepressant Era,” rejected the notion that the safety information could be treated like any other private property. Healy prescribes the medicines but has campaigned for more cautious use and more accurate labeling.
“On a pressing issue like this,” he said, “there is no reason these data could not be put into the public domain in their entirety.”
The FDA said it is evaluating 20 studies in all, but agency officials have declined to identify them.
In the end, some scientists believe, the only way to ensure that science is conducted in the public interest is for it to be funded with public dollars. The National Institutes of Health is therefore ramping up funding for clinical trials.
“We have been dependent on the pharmaceutical industry to provide the answers,” said Thomas R. Insel, director of the National Institute of Mental Health. “The questions they want answered are different than the public health questions.”