Rep. Joe Barton, chairman of the House Energy and Commerce
Committee, said he may call a hearing to investigate if Food
and Drug Administration (news - web sites) officials tried to hide a medical
reviewer's conclusion that there was a link.
"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," Barton, a Texas Republican, said in a
statement.
The FDA is studying whether widely used antidepressants
such as Eli Lilly and Co.'s Prozac and GlaxoSmithKline Plc's
Paxil can make children and teenagers suicide- prone, but
officials said they have not yet reached a conclusion.
The primary medical reviewer on the issue, Dr. Andy
Mosholder, concluded there was a connection, according to a
letter from the FDA to the congressional committee.
Other reviewers, including Mosholder's direct supervisors,
disagreed, saying more analyzes were needed before the agency
could reach a conclusion, the FDA letter said.
FDA officials decided letting Mosholder present his views
at a February advisory panel meeting "would be potentially
harmful to the public health" because patients being helped by
the drugs might stop using them, the agency's letter said.
But officials did not try to hide the information, the FDA
said.
"We specifically acknowledged at the public meeting that
some within the agency had reached different conclusions," the
letter said.
The advisory panel, a group of experts from outside the
agency, urged officials to issue stronger warnings about the
possible risks of suicidal behavior in children, while the
agency review proceeds.
Last month, the FDA warned that patients taking
antidepressants should be closely monitored for signs of
worsening depression and suicidal thoughts.
In the letter to the congressional panel, the agency said
it was evaluating data carefully and did not want to make a
premature determination.
"The health risks of incorrect conclusions are potentially
great," the letter said.
