On February 27, 2006, an excerpt from a previously sealed product liability report against GlaxoSmithKline (GSK) was made public. The medical expert report documents how the company systematically hid and manipulated data concerning Paxil-induced suicidality in depressed adults. The number of suicide attempts on the antidepressant Paxil was under-reported and the number of suicide attempts on placebo was inflated.
The entire product liability report is reproduced on www.breggin.com. It further documents how GSK hid the incidence of Paxil-induced akathisia (agitation with hyperactivity) and stimulation. Akathisia and stimulation are risks factors for suicidality and violence. The product liability report also cites previously unreleased FDA correspondence critical of GSK’s marketing and advertising tactics in regard to Paxil.
The excerpts were published as part of a Special Report by Peter R. Breggin, M.D. in Ethical Human Psychology and Psychiatry (Volume 8, Spring 2006, pp. 77-84). Dr. Breggin’s original psychiatric expert report was written for Lacuzong v. GSK and signed as an affidavit in California on July 21, 2001. It was based on a three-day examination of GSK’s sealed files at the company headquarters.
The Lacuzong case was brought by the widow of a man who drowned their two children and himself in a tub after taking Paxil for three days. The attorney was Don Farber of San Rafael, California.
The Lacuzong case was “resolved” to the satisfaction of the family; the drug company denied all allegations. At GSK’s insistence, Dr. Breggin’s report remained sealed. However, in a more recent case against the company, Moffett v. Glaxo SmithKline, the United States District Court for the South District of Mississippi, the report was filed in the public record and is now available at the court as well as on http://www.breggin.com.
The FDA has recently issued a preliminary warning that newer antidepressants like Paxil may cause increased suicidality in adult patients. The FDA is planning further scientific review but, as this special report indicates, drug companies do not always reveal critical data to the agency.
Dr. Breggin stated, “The drug companies settle almost all legal cases brought against them in order to seal incriminating scientific data. This deprives the FDA, medical profession and public of critical information on drug safety and efficacy. The publication of a previously sealed medical expert report is a rare event—the first in my experience. The law should be changed to require drug companies to publish all of the safety and efficacy data they generate in regard to their drug products.”
In May 2006, in a move that had nothing at all to do with Dr Breggin’s report being made public, of course, GSK made a stunning admission.
In a release in collaboration with the manufacturer GlaxoSmithKline (GSK), the FDA acknowledged the antidepressant Paxil caused a statistically significant increased rate of suicidality in depressed adults as measured in controlled clinical trials. The results are based on a re-analysis of all adult controlled clinical trials that compared Paxil with placebo.
Buried in the FDA/GSK release was an astounding fact: Depressed people are 6.4 times more likely to become suicidal while taking an antidepressant than while taking a sugar pill.