Drug Company Suppressed Data on Paroxetine-Induced Stimulation: Implications for Violence and Suicide

Abstract

This is the third special report in a series that has published observations and excerpts from my 1999 product liability report in the California case of Lacuzong v. GlaxoSmithKline, alleging that Paxil (paroxetine) caused a double murder and suicide. Shortly after the publication of my first special report in EHPP (Breggin, 2006a), the Food and Drug Administration (FDA) and the drug company GlaxoSmithKline (GSK) confirmed my basic conclusion that Paxil causes increased suicidality in adults (Kraus, May 2006). The GSK meta-analysis of all placebo-controlled clinical trials for Paxil demonstrated that adults of all ages with major depressive disorder suffered a 6.4 times increase in the rate of suicidal ideation and behavior compared to the controls receiving the sugar pill (0.32% vs. 0.05%). In addition to increasing suicidality in depressed adults of all ages, Paxil also increased suicidality in young adults (ages 18-24) suffering from anxiety disorders. My product liability report demonstrated that the drug company had been hiding and manipulating the relevant data for many years prior to the recent publication of data showing that Paxil causes suicidality in adults. The product liability suit was brought by the wife of a man who drowned himself and their two children two days after beginning to take a daily 10-mg dose of the selective serotonin reuptake inhibitor (SSRI) antidepressant Paxil. Although GSK denied all allegations, the suit was resolved to the satisfaction of the plaintiffs. My original product liability report was sealed as a part of the settlement, but subsequent events in another lawsuit against GSK in which I was also the plaintiff's expert enabled me to make it public (discussed in Breggin, 2006a). That case has recently been settled as well. My product liability report was based upon a 3-day trip to the offices of GSK in order to examine the company's complete library of documents relating to the development and marketing of Paxil. My initial report in EHPP focused on GSK's manipulation of data concerning Paxil-induced suicidality in adults (Breggin, 2006a). The second report in EHPP focused on how GSK hid data on drug-induced akathisia (Breggin, 2006b). Akathisia (psychomotor agitation) is very emotionally distressing and is known to cause suicide, violence, and an overall decline in the individual's mental condition (DSM-IV-TR, pp. 800-802). The current report focuses on the role of Paxil-induced central nervous system stimulation in causing violence and suicide and the manner in which GSK obscured or disguised the antidepressant's stimulating effects. Akathisia can be viewed as a form of central nervous system stimulation, and therefore this current report dovetails with the second report. In January 2005, the FDA compelled the manufacturers of antidepressants to include a great deal of new information about psychiatric adverse drug effects in their official labels. Closely paralleling observations I had been developing over more than a decade concerning the stimulating effects of these drugs (Breggin, 1991, 1997, 2001, 2003), the agency required the following observations to be placed on all antidepressant labels, including Paxil (Food and Drug Administration, January 26, 2005, p. 2): The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness), impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Note that the label change applies to both adults and children and to people given the medication for psychiatric or nonpsychiatric purposes. However, the drug company continued to maintain that there was no proof of Paxil causing suicide in adults until the recent publication of the results from the placebo-controlled clinical trials (Kraus, 2006). …