FDA scientist barred from giving anti-depressant report

A scientist at the Food and Drug Administration has been barred from publicly presenting his finding that several leading anti-depressants may increase the risk of suicidal behaviors among children, according to sources inside the FDA.

FDA medical officer Andrew Mosholder was to present his report Monday at an FDA advisory hearing in Washington that promises to be a contentious affair involving competing medical experts and parents whose children took their own lives while on the medications.

A senior FDA official said the study wouldn't be presented because it wasn't "finalized." But critics fear that the agency's action indicates it is not prepared to take stronger action against the drugs, despite warnings about their possible effects on children.

Mosholder had been asked by the agency to perform a safety analysis of anti-depressants after reports emerged this summer of high rates of suicidal behavior among children enrolled in clinical trials for Paxil, Effexor and other anti-depressants.

Mosholder, a child psychiatrist, reviewed data from 20 clinical trials involving more than 4,100 children and eight different anti-depressants. His preliminary analysis, according to two FDA sources familiar with the report's contents, concluded that there was an increased risk of suicidal behavior among children being treated for depression with Paxil and several other anti-depressants.

An initial agenda for Monday's hearing listed Mosholder and his findings, but his presentation was removed from a revised agenda, and Mosholder was told that he could not present his findings at the hearing, one FDA official, who wished to remain anonymous, told The Chronicle.

According to the official, in early January, Russell Katz, director of the division of neuropharmacological drug products, called Mosholder in for a meeting. "He told him that he was sorry, but he wasn't going to be able to present (his report) because he had reached a conclusion and therefore was biased," the official said.

Mosholder declined several requests to be interviewed and was not made available despite repeated requests to FDA's press office. Katz was unavailable to comment on the charges.

In a telephone interview Friday with The Chronicle, Anne Trontell, deputy director of the agency's Office of Drug Safety, who is Mosholder's direct supervisor, said the analysis would not be presented because it had not yet been approved within her office.

"The consult on that is not finalized. It's not a final document within the Office of Drug Safety," Trontell said.