Suppressed Paxil Suicide Data Released

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[sSRI-Research] Suppressed Paxil Suicide Data Released

Received from Peter Breggin...

 

Press Release

 

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. "

 

 

 

Contact Information:

 

Peter R. Breggin, M.D.