Kernersville, North Carolina, February 16, 2004 – The mother of a teenage girl who attempted suicide while taking Effexor for migraine headaches has asked the Department of Health and Human Services (HHS) to remove three FDA officials from having any oversight over the review of suicide risk in children and adolescents taking SSRI antidepressants. Jennifer Tierney of Kernersville, North Carolina told officials from the HHS Commissioner’s office, with whom she met on Tuesday, February 3, 2004, that FDA officials, Russell Katz, Robert Temple, and Thomas Laughren should not be permitted to have any involvement in the antidepressant review currently taking place due to their past failures to protect the public health on these very issues.
Tierney stated in a letter sent on February 16, 2004, that she and other victims who met with the Commissioner’s office on February 3rd “have little confidence in the current regime (Temple, Katz, and Laughren) and do not believe they have the necessary objectivity to oversee this process, after all, it was their failure to ensure further research was conducted [when the issue was first raised in 1991] that has placed millions of people at risk and potentially killed tens of thousands of people, including children. How can you expect them to objectively adjudicate a matter for which they are, in part, culpable?”
The February 3rd meeting came the day following an FDA Advisory Committee meeting held to discuss the risk of suicide in children and adolescents taking the antidepressants Paxil, Zoloft, Prozac, Luvox, Celexa, Effexor, Wellbutrin, Serzone, and Remeron. The FDA advisory panel urged the FDA to issue warnings about the potential risk immediately. The FDA has not issued anything to date.
On December 10, 2003, the UK government announced that all SSRI antidepressants (except Prozac) would be contra-indicated for use in children and adolescents under 18 in the UK due to their lack of efficacy and a 2 to 3 times greater incidence of suicidal behavior in those taking the antidepressants over placebo.
Tierney was joined at the February 3rd meeting by about a dozen other individuals who have lost a child or other loved one to suicide while taking an antidepressant. Dr. David Healy, an outspoken critic of the drugs (from the University of Wales College of Medicine) was present as was Richard Brook, a member of the UK expert panel that banned the use of the drugs in children and adolescents in the UK. Attorney Karen Barth Menzies of Baum Hedlund and Chris Coffin of the Pendley law firm sat in on the meeting. Menzies stated: “It was clear from this meeting that Bob Temple and the FDA remain aligned with the drug companies and the FDA is proving to be one of the biggest obstacles to getting warnings out to doctors and parents, despite the advisory committees’ demands.”
Documents of Interest:
- October 3, 1990, internal GSK memo that states that the FDA did not consider the SSRI suicide issue “a real issue, but rather as a public relations problem . . .
- October 23, 1986 internal FDA memo that states Lilly (the maker of Prozac) “has a friend in Dr. Temple.”
- February 7, 1990 internal Lilly memo that states: “Although [Paul Leber of FDA] is a fan of Prozac and believes a lot of [the concern over the increased risk of suicide] is garbage, he is clearly a political creature and will have to respond to the pressures.”
- September 11, 1990, an internal FDA memo critical of Lilly’s meta-analysis of clinical trial data related to suicidal behavior and violence.
- July 18, 1990 internal Lilly memo memorializing a conversation with FDA: “Dr. Leber said: ‘I agree that [Lilly’s] experts on suicide can give [Lilly] good testimony on 20/20, Nightline, and 60 minutes, but what we really need are good data.’ I agreed and committed that Lilly would perform a new study of this issue to be designed in concert with him, with no commitment to design scope or timing.” Also: “FAX nothing to [Leber] unless he has agreed to it beforehand. He said that ‘someone has found that mailbox and it makes the second route of information.’ So he said he was warning people like us NOT to use FAX unless we had
specifically agreed with him to do so.”