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FDA kept suicide findings secret

By ELIZABETH SHOGREN
Los Angeles Times
Published on: 04/06/04
WASHINGTON -- Ten months ago, when concerns arose about a possible link between
children taking antidepressant drugs and suicide attempts, senior officials
at the Food and Drug Administration ordered their leading expert to head up
an examination of the evidence.
When the government scientist filed his report last winter, however, his
bosses decided to keep it secret — even though it found that children who
took the drugs were twice as likely to be involved in serious suicide-related
behavior as those who did not.
Instead of revealing the findings, senior FDA officials ordered more studies,
which are not expected to be completed until summer. They also squelched
plans to have the author, Dr. Andrew Mosholder, present his conclusions to
an FDA advisory committee when it took up the issue in February.
Mosholder's report still has not been made public, but news of his conclusions
first surfaced in a CBS News report last week. His findings were detailed
in an internal FDA document obtained by The Los Angeles Times and authenticated
by government officials.
In March, when the agency issued a warning about the possibility of problems
for young patients taking the drugs, FDA officials said no conclusive scientific
evidence existed on the link between antidepressants and potentially suicidal
behavior by children. Officials said they based their action on anecdotal
complaints from physicians and families that had been presented to the advisory
committee.
They gave no hint that their own chief expert on the subject had examined
the results of more than two dozen clinical trials conducted by antidepressant
manufacturers and had found an unusually high correlation between their use
by young patients and potentially suicidal behavior.
In justifying their decision to hold back Mosholder's report, his superiors
questioned the reliability of the data on which he based his conclusions.
They suggested the drug companies, which manufacture the antidepressant drugs
and conducted the clinical trials in order to market them, might have been
too quick to count some behavior as potentially related to suicide — that
is, too quick to raise questions about their own products.
Among the kinds of actions these officials said should not necessarily have
been counted as potentially suicide-related were instances of children who
deliberately cut themselves.
Some FDA officials defended the decision to sit on the report and seek more
analysis of the data, but some psychiatrists and congressional leaders who
are following FDA's handling of the issue were angered that the agency had
kept Mosholder silent.
"
Evidence that they're suppressing a report like this is an outrage, given
the public health and safety issues at stake," said Dr. Joseph Glenmullen,
a Harvard psychiatrist who wrote a book on the problems with the drugs known
as serotonin reuptake inhibitors, which alter brain chemistry to manage depression. "They've
been claiming that there's no evidence. Here's the evidence." Senate
and House committees have ordered the FDA to hand over documents that might
illuminate what the agency knew about the possible link between the drugs
and suicidal behavior.
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