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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with the unpublished data said the majority of secret trials show that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."
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