(04-15) 15:53 PDT WASHINGTON (AP) --
A House committee says it will investigate whether the Food
and Drug Administration fully disclosed the disagreement among
its scientists about whether antidepressants might be linked
to suicide in children.
The FDA insists it is not clear whether the drugs have any
link to suicidal behavior by children or teenagers, noting
that depression itself can lead to suicide. An extensive
agency investigation is under way; results are due this
summer.
But at a Feb. 2 public meeting, FDA officials announced
that some agency scientists believe a link already is proved,
and presented the cases of possibly suicidal behavior.
At that meeting, the FDA's scientific advisers concluded
that such a link has not be proved. They said that until the
issue is settled, parents need to be warned that the drugs may
cause agitation, anxiety and hostility among patients
unusually vulnerable to rare side effects.
Critics complain that the FDA scientist who told his bosses
he was convinced of a link, Dr. Andrew Mosholder, has been
muzzled. Mosholder attended that February meeting but did not
discuss his conclusion.
In a letter to Congress that was released Thursday, the FDA
offered an explanation: While his boss presented Mosholder's
data, top officials did not think Mosholder should argue the
case was closed when that was not the agency's position.
"Having Dr. Mosholder present his conclusion to the
advisory committee, with the appearance that it was an agency
determination ... might lead patients who were actually
benefiting from the use of these drugs to inappropriately
discontinue therapy," the FDA wrote the House Energy and
Commerce Committee.
The agency has urged caution in prescribing adult
antidepressants for children. In addition, bowing to pressure
from families, the agency warned last month that patients of
any age should be monitored closely for signs of suicide when
they first start antidepressants or change a dose.
But members of Congress question whether the FDA has gone
far enough. Rep. Joe Barton, the House committee chairman,
promised further investigation.
"There are troubling questions of whether FDA supervisors
inappropriately suppressed significant information that would
have been of consequence to their own advisory committee, not
to mention the public," said Barton, R-Texas.
The FDA's drug chief, Dr. Robert Temple, said it is not
unusual for agency scientists to disagree. He said the
agency's advisers were given a clear picture of that
disagreement and the data behind it.
"Nobody should think we're shrinking from this -- we raised
it," he said.
"We don't want to scare people off drugs that may very well
be useful. We don't want to exonerate drugs if they really are
increasing the risk," Temple said. "We thought the investment
of a few more months was worth it to get it right."
Last spring, the FDA spotted puzzling side-effect reports
in studies of the use of the drug Paxil by children.
The FDA ordered details from the makers of Paxil and other
antidepressants, reports that mentioned possibly suicidal
behavior. That led the FDA to warn doctors to use caution when
prescribing the drugs for minors while the agency assessed the
risk.
British health authorities went much further, saying that
because only one drug, Prozac, has been proven to alleviate
pediatric depression, others are unsuitable for depressed
youth.
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