On September 13 and 14, 2004, at a public hearing of the FDA's Psychopharmacologic Drugs and Pediatric Advisory Committees (PDAC), FDA officials discussed the issue of pediatric efficacy studies and the risk of suicidality involving antidepressants, particularly focusing on the SSRI and SNRI class of antidepressants including Paxil, Zoloft, Prozac, Luvox, Celexa, and Effexor. After two days of testimony by victims, parents and experts, in combination with previous testimony from the PDAC's hearing in February and other evidence, the committee recommended that antidepressants include a “black box” warning, the FDA’s most severe warning, that antidepressants not only cause some minors to become suicidal, but have also failed to demonstrate that they relieve depression.

The committee voted 15-to-8 for a “Black Box” warning for children and adolescents after reviewing clinical-trial data that showed the drugs are twice as likely as a placebo to cause suicidal thoughts or behavior.

Baum Hedlund partner, Karen Barth Menzies, testified at both hearings. At the September hearing she stated:

“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.

 

“But today, I'm not going to talk about the suicide risk. Plenty of people are going to be addressing that today. What I will talk about is efficacy.

 

“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.’"

---

FDA on Antidepressant Use in Children, Adolescents, and Adults

 

Congressional Hearing
FDA's Role in Protecting the Public Health: Examining FDA's Review of Safety & Efficacy Concerns in Anti-Depressant Use by Children
Subcommittee on Oversight and Investigations
September 23, 2004
2123 Rayburn House Office Building
11:00 AM

 

Congressional Hearing
Publication and Disclosure Issues in Anti-Depressant Pediatric Clinical Trials
Subcommittee on Oversight and Investigations
September 9, 2004
2123 Rayburn House Office Building
11:00 AM

 

California Senate Hearing on Antidepressant Drugs and Suicide
SENATE HEARING TO EXAMINE ANTIDEPRESSANT DRUGS AND SUICIDE

Baum Hedlund partner, Karen Barth Menzies, accepted an invitation from Senator Tom Torlakson, Chair of the California Task Force on Youth and Workplace Wellness, to testify at the joint informational hearing of the California Senate Health and Human Services Committee and the Statewide Task Force on Youth about suicide and antidepressant medications which took place on August 4, 2004 at the State Capitol.

 

Newsday: TELL TRUTH ABOUT ANTIDEPRESSANTS
On drug labels and in medical journals

 

Reuters: FDA Agrees on Antidepressant Risks for Youth