Court Filing Makes Public My Previously Suppressed Analysis of Paxil’s Effects

Abstract

In late 1999 I was asked by attorney Don Farber to be the medical expert in a product liability case brought by the family of Reynaldo Lacuzong against the drug company Glaxo SmithKline (GSK) in California. Mr. Lacuzong was a machine operator with no prior history of serious mental illness, violence, or suicidality before he was prescribed a relatively small dose of 10 mg of Paxil (paroxetine). Almost immediately after starting the Prozac-like selective serotonin reuptake inhibitor (SSRI) antidepressant, he developed akathisia-an inner agitation accompanied by a compulsive hyperactivity-as well as other manic-like signs of irritability and anxiety. Antidepressant-induced akathisia is known to be associated with violence, suicide, psychosis, and an overall mental deterioration (American Psychiatric Association, 2000, pp. 800-802). Depression with drug-induced agitation can produce similar results. On the third day of taking Paxil, Mr. Lacuzong drowned himself and his two small children in a bathtub. As a medical expert, I was empowered by the court to examine hundreds of cartons of drug company files contained in GSK's sealed record room. These files included Food and Drug Administration (FDA) correspondence and all of the company's worldwide clinical trials and adverse drug reports for Paxil. On July 21, 2001, my report in the form of an affidavit was sent to the judicial arbitrator in the case. It addressed GSK's practices in the development and marketing of Paxil, and in particular its alleged withholding or manipulation of information about the drug's dangerousness. Based on GSK's proprietary files that have to this day never been made public, my report examined many factors, including (a) how quickly after the first dose can Paxil cause severe adverse reactions; (b) the actual rates of akathisia; (c) the actual risk of overstimulation causing agitation, irritability, and manic-like symptoms; (d) the actual rates of suicidality in adults; and (e) promotional claims made for the drug. The case against GSK was eventually "resolved" to the satisfaction of GSK and the Lacuzong family. GSK denied and continues to deny all of the allegations of negligence in developing and marketing Paxil. My impression is that a substantial amount of money was involved in the resolution of the case, although the amount was not disclosed. GSK at that time refused to unseal its records or to allow me to make public my findings, regardless of their significance for the FDA, medical profession, and public health. On June 23, 2005, my report in the Lacuzong case was filed as a part of a motion in another Paxil case, Moffett v. Glaxo SmithKline, in the United States District Court for the Southern District of Mississippi. Because it was filed in the public record, my report is now available to the public, and I am able to comment on the details. The complete version appears on my website www.breggin.com. The report should prove useful to the FDA, health practitioners, scientists, researchers, attorneys, consumers, and anyone concerned about how drug companies function in the development and marketing of their products. In the meanwhile, the FDA has recently acknowledged many of my original observations about the stimulating effects of all of the SSRIs like Paxil and Prozac, as well as other new antidepressants such as Effexor. I first warned about these effects in Toxic Psychiatry (Breggin, 1991 ) and then in subsequent peer-reviewed articles and books (see for example, Breggin, 1997, 2001, 2003). As of 2005, the FDA now requires the drug manufacturers to place elaborate warnings on their labels concerning the potential of these drugs to cause stimulating effects, including agitation, anxiety, irritability, emotional lability, aggression, hostility, and mania. The labels must also include a warning about increased suicidality in children. Without coming to a scientific conclusion, the FDA has also warned about and begun to investigate the problem of antidepressant suicidality in adults. …