Baum Hedlund and Clients Testified at FDA Antidepressant Hearings

Several Baum Hedlund staff and clients attended the three Food and Drug Administration (FDA) advisory committee hearings held in 2004 and 2006 on the subject of SSRI-antidepressants and their link to suicide. One of our attorneys testified at all three hearings and stated at one of the meetings, “Put me out of business for the right reasons. Warn about these drugs.”

Victims of antidepressants and clients of Baum Hedlund also testified at the FDA hearings. They each told their story of how they tried to commit suicide while on an antidepressant or why they believe their loved one’s suicide was caused by an antidepressant.

The FDA heard their stories among many others, and also from lawyers and experts and subsequently decided on October 15, 2004 that a black-box warning should be placed on antidepressants that would alert health care providers to an increased risk of suicidality caused by antidepressants in children and adolescents. The FDA acknowledged that: “A causal role for antidepressants in inducing suicidality has been established in pediatric patients.”

After the FDA hearing on December 13, 2006, the FDA on May 2, 2007 announced that it asked antidepressant manufacturers to expand the current black box warnings concerning the increased risk of suicidality in children and adolescents to include young adults, but only ages 18 to 24.

Unfortunately, this later warning, rather than simply and accurately informing the public that this side effect can occur in some people – no matter their age, instead gives the false perception that some age groups are entirely safe while others are not. Does a drug know how old a person is? It is unrealistic and unwise to think that a person is at risk the day before their 25th birthday, but then safe and no longer at risk of becoming suicidal while taking these drugs one day later.

FDA Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee regarding the risk of suicide in children and adolescents taking antidepressants.

February 2-4, 2004

The committee discussed reports of the occurrence of suicidality (both suicidal ideation and suicide attempts) in clinical trials for various antidepressant drugs in pediatric patients with major depressive disorder (MDD). The committee considered optimal approaches to the analysis of data from these trials, and the results of analyses conducted to date, with regard to the question of what regulatory action may be needed pertinent to the clinical use of these products in pediatric patients. The committee agreed further research is needed on this topic.

Baum Hedlund testified at this hearing and presented the following:

US Code of Federal Regulations 201.57 mandates that you require the drug companies to warn when there is reasonable evidence; not causation; reasonable evidence of an association of a serious risk. The clinical researchers who did these trials on kids and the drug companies themselves, confirmed that there are multiple events of suicidality caused by the drug. The methodology that you are going to be using is designed to explain away those events. Even Dr. Laughren admits, in the memo he gave you for this hearing today, that there is evidence in these trials of an increased risk of suicidality. Reasonable evidence is there. If there’s reasonable evidence you must make them warn.

Serious risk? We certainly have that. Akathisia, psychosis, mania. When you’re looking at this data you’re not just looking at the suicide, also look for signs of akathisia and psychosis and mania. These aren’t as easily explained away by the drug companies by blaming the disease; by blaming the victims. When you take the potentially fatal risk and couple that with lack of efficacy of these cases, why take that risk? Especially when it comes to our kids.

Paul Leber predicted this day when he said that the FDA would come under attack because they weren’t as demanding as they ought to have been when they were looking at the efficacy of the antidepressant products.

Follow-up to the February 2004 meeting – 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.

September 13-14, 2004

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. Over the course of two days, Baum Hedlund clients Kim Witczak and Beverly Hatcher testified among other victims, parents and experts. With this testimony and the combination of previous testimony from the PDAC’s hearing in February 2004 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.

In addition, the FDA finally conceded that an investigation of the suicide risk in adults would be conducted as well.

Baum Hedlund Testified as follows:

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.’

FDA’s Psychopharmacologic Drugs Advisory Committee concerning the FDA’s Review of Suicidality Data in Adult Antidepressant Studies

December 13, 2006

FDA’s Psychopharmacologic Drugs Advisory Committee concerning the FDA’s Review of Suicidality Data in Adult Antidepressant Studies

The committee’s agenda at this meeting included discussions of the results of the FDA ongoing meta-analysis of suicidality data from adult antidepressant trials.

On May 2, 2007, the FDA announced that it has asked antidepressant manufacturers to expand the current black box warnings concerning the increased risk of suicidality in children and adolescents to include young adults (ages 18-24).