Baum Hedlund testified at the September 13-14, 2004 joint meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee and the Pediatric Drugs Advisory Committee concerning the risk of suicide in children and adolescents taking antidepressants and presented the following:

Baum Hedlund testified at the September 13-14, 2004 joint meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee and the Pediatric Drugs Advisory Committee concerning the risk of suicide in children and adolescents taking antidepressants.Baum Hedlund’s attorney testified, "Through the litigation process, our experts see more evidence concerning the true risks versus the true efficacy of these drugs– more than anyone anywhere. That includes the FDA. Court imposed protective orders don’t permit us to show this evidence to the FDA or even the congressional investigators or you. I can tell you that the companies have known about the serious risk and the lack of efficacy since the mid 1980s.

"For purposes of illustration and because of what I have just heard earlier today, I'm going to focus on Zoloft. Dr. Paul Leber, former FDA veteran of over 20 years, who was principally involved in the investigation, analysis and approval of the SSRIs, wrote in a memo from August of 1991, and I quote: ‘In recommending [the approval of Zoloft for adults], I have considered the fact that the evidence marshaled to support [Zoloft's] efficacy as an antidepressant is not as consistent or robust as one might prefer it to be.’

"Back in 1991, Dr. Leber noted that numerous countries around Europe had already rejected or were about to reject approval of Zoloft because Pfizer could not demonstrate efficacy. It was only until after FDA approved Zoloft that the rest of the countries followed.

"In 1991, Dr. Leber stated, and I quote: ‘Approval of Zoloft may come under attack by constituencies that do not believe that FDA is as demanding as it ought to have been in regard to their standard of establishing the efficacy of antidepressant.

"Just yesterday, Dr. Leber was quoted again, in the Denver Post, stating: ‘Second generation antidepressants were approved by a regulatory process that requires only limited proof of efficacy and safety.’ Dr. Leber also stated: ‘You're working in a sea of ignorance.’ He concluded, ‘I do have some doubts about these drugs’ values and the big picture.’"

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