Baum Hedlund testified at the February 2-4, 2004 FDA Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee hearing regarding the risk of suicide in children and adolescents taking antidepressants.Baum Hedlund testified at the February 2-4, 2004 FDA Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee hearing regarding the risk of suicide in children and adolescents taking antidepressants.

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.

 

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