Probe planned of FDA's antidepressant, suicide review
Sunday, May 2, 2004 Posted: 4:34 PM EDT (2034 GMT)
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 been proven. 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.
Time to get it right
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.
 |
 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. 
-- Rep. Joe 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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