March 6, 2006
Suppressed Paxil Suicide Data Released
Expert Calls for Drug Companies to Publish Safety and Efficacy Data
Newly released information demonstrates that the manufacturer of Paxil withheld key data concerning the risks associated with its antidepressant Paxil. The drug company Glaxo SmithKline failed to release its complete data concerning rates of suicidality on Paxil. In the information that was originally provided to the FDA, the number of suicide attempts on the antidepressant Paxil was under-reported and the number of suicide attempts on placebo was inflated. The drug company also hid the stimulating effects of the drug that pose a potential risk for causing violence.
The new information is contained in a previously sealed product liability report against Glaxo SmithKline (GSK) concerning Paxil. The medical expert's report documents how the company systematically hid and manipulated data concerning Paxil-induced suicidality in depressed adults. It also 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.
Excerpts from the product liability report are being published this week 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). The Special Report and the entire product liability report are both reproduced on www.breggin.com.
The original psychiatric expert report was written by Dr. Breggin for Lacuzong v. GSK and signed as an affidavit in California on July 21, 2001. It was based Dr. Breggin's 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 and is now available at the court as well as on 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."
Peter R. Breggin, M.D.
607 272 5328
Dr. Breggin's latest book is Medication Madness: A Psychiatrist Exposes the Dangers of Mood-Altering Medications (2008) and his revised and updated website is Breggin.com.
Follow Dr. Peter Breggin on Twitter: www.twitter.com/GingerBreggin