Healthy Skepticism Library item: 870

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Publication type: news

Reuters .
US Reviewer Says Pressured in Antidepressant Probe
The New York Times 2004 Sep 23

Full text:

A U.S. government medical reviewer who raised concerns about antidepressant use by children said on Thursday he was pressured to hide information and submit an altered document to congressional investigators.
Dr. Andrew Mosholder, a Food and Drug Administration epidemiologist, said agency officials did not want lawmakers to know the agency was conducting an internal probe of whether he leaked his concerns about antidepressant risks to a reporter.

Mosholder concluded last year that children and teens who took antidepressants during clinical trials were more likely to report suicidal thoughts or actions. His superiors disagreed and prevented him from presenting his findings at a public meeting last February.

The Senate Finance Committee began investigating. Mosholder wanted to give the panel an affidavit drawn up for the FDA probe in which he said he did not leak the information.

In testimony before the House Energy and Commerce Committee on Thursday, Mosholder said FDA officials told him to remove a reference to the agency’s probe, as well as some names to protect privacy.

``Had Dr. Mosholder not acted to thwart the submission of an altered document to a bona fide congressional investigation, a criminal act of obstruction of justice would have occurred,’‘ charged Rep. Peter Deutsch, a Florida Democrat.

Mosholder said FDA officials told him not to tell congressional investigators the document had been changed.

In a May 4 e-mail to Mosholder an official in the FDA chief counsel’s office wrote, ``I don’t think that it’s necessary to indicate that this document represents a version of the earlier one by noting things have been omitted. That simply invites the committee to ask further questions about what was in the earlier version.’‘

Mosholder said that made him uncomfortable and he eventually provided the committee his original document minus the names.

The FDA has been accused of trying to conceal information throughout the antidepressant controversy. Despite Mosholder’s findings months ago, top officials did not confirm a link between antidepressants and suicidal behavior in youth until last week.

Dr. Robert Temple, director of the FDA’s Office of Medical Policy, defended the agency’s actions. He said data were unclear and officials wanted to be certain of the risks before warning doctors and the public.

``The agency realizes its responsibility to the public to find the right answer to this question,’‘ Temple said at the hearing.

For some patients, the drugs can be life-saving by relieving depression, a serious mental illness that itself raises the risk of suicide.

Lawmakers at the hearing said one FDA medical reviewer raised the question of whether Pfizer Inc.‘s Zoloft might increase the risk of suicidal behavior in pediatric patients in 1996.

The FDA now is drafting new warnings for all antidepressants about the possibility of suicidal thoughts and actions among youth who take the drugs. A panel of outside experts has recommended the drug labels highlight the risk in a ``black box,’‘ the strongest warning for prescription drugs.

An FDA analysis estimated 2 percent to 3 percent of children and teens who take antidepressants might have an elevated risk for suicidal behavior. But no suicides occurred in studies of more than 4,000 children as young as six.

Antidepressants include Eli Lilly and Co.‘s Prozac, Pfizer’s Zoloft, GlaxoSmithKline Plc’s Paxil, Forest Laboratories Inc.‘s Celexa and Wyeth’s Effexor. Prozac also is sold under the generic name fluoxetine.