Newly released information contained in a hitherto sealed expert medical witness report filed in a product liability case demonstrates that the manufacturer of Paxil withheld key data concerning the risks associated with its antidepressant Paxil when taken by adults.
In a press release issued by Dr. Peter Breggin, the author of the previously concealed court document, states:
"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 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 report also cites previously unreleased FDA correspondence critical of GSK’s marketing and advertising tactics in regard to Paxil.
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.
"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."
The Lacuzong case was brought by the widow: the 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 (June 2005) and is now available at the court as well as on: http://www.breggin.com/Breggin%20Paxil%20Lacuzong%20Report%20Filed%20with%20Court.pdf.
Among the documented findings in Dr. Breggin’s report:
"In a 9.6.94 letter from Sherry Danese to Michael Brennen at SKB, the company’s promotional materials are again heavily criticized. This letter is particularly important
because it demonstrates a specific attempt on the part of SKB to mislead doctors concerning the stimulant effects of Paxil.
This is directly relevant to the issue of murder and suicide, both of which can be related to the stimulating, agitating effects of antidepressants.
From this material alone it can be concluded that SKB attempted to hide the dangers of Paxil in regard to stimulation and its adverse consequences of murder and suicide.
In the letter, according to the FDA’s criticism, SKB made the following statement:
Effective in treating anxiety and agitation associated with depression without inducing symptoms of arousal."
"The FDA observed that the above handwritten letter and a two page typed “Paxil Overview” sheet “appear to have been distributed by a SmithKline Beecham (SKB) sales
representative” (p. 1). The FDA was strongly critical:
This statement suggests that Paxil is not associated with side effects that might aggravate anxiety or agitation. To the contrary, Paxil is associated with an 8.3% incidence of tremor, a 5.2% incidence of nervousness, a 13.3% incidence of insomnia, a 5.0% incidence of anxiety, and a 2.1% Breggin Preliminary Report, p. 5
incidence of agitation. Therefore this statement is false and/or misleading. P. 3.
"Importantly, the FDA analysis also establishes the rudiments of a stimulant profile for Paxil, including the following symptoms:
Tremor / Nervousness / Insomnia / Anxiety / Agitation
It also establishes that Paxil can cause or worsen “anxiety and agitation associated with depression.” "
Excerpts from the original product liability report are being published as part of a Special Report 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: http://www.breggin.com/courtfiling.pbreggin.2006.pdf .
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.”
As the excerprt below demonstrates, this report documents violations that go way beyond those the company was charged with by New York state Attorney General, Eliot Spitzer. See:
1. Suicide Attempts: U.S. Clinical Trials. A total of 14 suicide attempts were reported in the U.S. clinical trials. None were completed suicides. An overview is presented in Table 1 (PAR Safety Summary 20-Nov-1989, p. 203, stamped p. 297). Note that the rate for suicide attempts on paroxetine approaches 1%, which the FDA considers “frequent.”
Also note that the rate for suicide attempts on paroxetine is 3.8 times higher than for placebo and 3.6 times higher than for the comparison antidepressants (tricyclics).
Furthermore, the suicide attempt on imipramine is listed as a “possible suicide” (p. 211, stamped 306).
In regard to the onset of suicide attempts, one patient (117A-004, p. 200, stamped 291) cut himself on the third day of Paxil:
“One day 3 this patient attempted to slash his wrists and abdomen and was withdrawn from the study.”
Also note that case 647 002 (above) made attempts on days 1, 8, and 15.
This all-important United States data is not presented in the text of SKB’s (now Glaxo SmithKline or GSK) April 29, 1991, report for the FDA, “Suicidal Ideation and Behavior: Analysis of the Paroxetine Worldwide Clinical Database.”
To hide the U.S. data within worldwide data was extremely misleading.
The contents of this previously concealed report should give pause to those who think product liability litigation is only about enriching trial lawyers. Tthe fact is, the pharmaceutical industry giants–with tacit complicity by the government oversight agency that has lost its way–are able to conceal the most damaging facts about the products the FDA approves for wide marketing without so much as full disclosure of the hazardous risks. Only the court provide a mechanism for getting at the truth–even though current laws allow defendant companies to keep documents sealed. It is strictly in the public interest to change the law and open the documents to public scrutiny. By sealing relevant documents, a symbiotic relationship is formed: companies can continue to engage in fraudulent marketing resulting in preventable human tragedies, and lawyers can get rich by suing multiple times for the same violations.
Where is the logic? where is the justice?
Contact: Vera Hassner Sharav