January 2006Lawsuit: William P. Williams brings an action on behalf of his son Kevin, files an amended complaint in the Northern District of California, alleging that William and Kevin suffered personal injuries as a result of Kevin’s ingestion of Paxil in March and April of 2003, when Kevin was 14 years old.

After being on Paxil for about four days, Kevin violently attacked his father. Kevin was then taken to the Contra Costa juvenile detention facility, where he later attempted to commit suicide by hanging himself in his cell, the complaint said.

March, 2006Lawsuit: A case is filed in the U.S. District Court in the Eastern District of Pennsylvania by the families of two young patients who had been prescribed Paxil. Eleven-year-old Trevor Blain was prescribed Paxil for "separation anxiety disorder" in October 2000. A month later, Blain allegedly attempted suicide by hanging himself with his dog's leash. Blain survived the suicide attempt but remained in a coma and later died.

Seventeen-year-old Tonya Brooks, was prescribed Paxil in 2004. She allegedly started cutting herself soon after taking the medication and attempted suicide after five months on the drug. Brooks first attempted suicide by overdosing with Paxil and Ambien, a prescription sleep aid. She survived the overdose but was involved in a serious car accident the next day, allegedly while still under the effects of the medications. Three days after her first suicide attempt, Brooks "gouged a three-inch deep hole in her leg", court documents said. This behavior, the plaintiffs alleged, ceased as soon as she stopped taking Paxil.

April 3, 2006 Article: "The Flawed Basis for FDA Post-Marketing Safety Decisions: The Example of Anti-Depressants and Children" by Donald F Klein.

John Mann, MD, Co-Chair of the heavily conflicted ACNP Task Force notes in an accompanying news release that "Given that untreated major depression is the main cause of suicide in children and adolescents, and that suicide is the third leading cause of death among 15-to-24 year-olds, there is an urgent need for effective antidepressant treatments."

May, 2006 — In response to an FDA requirement, GSK sends a "Dear Healthcare Professional" letter which states:

"Current prescribing information for paroxetine - and for all other antidepressants - contains information in the WARNINGS section …stating that "patients with MDD, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications… GSK has recently conducted a new meta-analysis… of suicidal behavior and ideation… Results of this analysis showed a higher frequency of suicidal behavior in young adults (prospectively defined as age 18-24) treated with paroxetine compared with placebo…"

This letter conveys the message that it is the depression, not the medication, that is the problem.

July 10, 2006Lawsuit: The family of Harold Garrison Jr, 16, who committed suicide on Paxil, launch a claim against Smithkline Beecham for failure to warn about the side effect of inducing suicidality, which was known to the company.

Aug 25, 2006Charles Nemeroff resigns as Editor of Neuropsychopharmacology:

"The editor of a leading psychiatry journal announced last Friday (August 25) that he was stepping down after he published a paper about a treatment for depression without disclosing that eight of nine authors - including himself - had financial ties to the company that makes the device. Charles B. Nemeroff, editor in chief of Neuropsychopharmacology, a publication of the American College of Neuropsychopharmacology (ACNP), will not serve another term as editor, the college told its members in an Email. The decision was made "in part, based on the recent adverse publicity to the journal and the ACNP…"

(See Nov, 2002, February 2003, Sept 26, 2003)

November, 2006FDA Psychopharmacologic Drugs Advisory Committee, Chaired by Daniel Pine, M.D., meets to:

"discuss the results of an ongoing meta-analysis of data on suicidality emerging from antidepressant trials. Historically, this has been an issue that has been examined by many organizations including the FDA in great detail over the last five or so years. The specific purpose is to look at newly available data that focuses on results compiled by the FDA in trials among adults where all the previous meetings we have spent time talking about data in children."

November, 2006 — Shelly Jofre from BBC's Panorama interviews Mina Dulcan, Editor of Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP), on the question of the ethics of publishing Study 329.

December 13, 2006FDA Psychopharmacologic Drugs Advisory Committee, Chaired by Daniel Pine, M.D., meets to:

"discuss the results of an ongoing meta-analysis of data on suicidality emerging from antidepressant trials. Historically, this has been an issue that has been examined by many organizations including the FDA in great detail over the last five or so years. The specific purpose is to look at newly available data that focuses on results compiled by the FDA in trials among adults where all the previous meetings we have spent time talking about data in children."