Pfizer’s Black Box Warning – First Kill All the Lawyers

“The first thing we do, let’s kill all the [trial] lawyers”                

                  Henry VI, (Part 2)  

Funny little ditty.  And very popular in this day and age of lawyer bashing.  But does anyone remember Shakespeare’s context? Jack Cade, the rebel, was plotting anarchy and firing up his followers.  He told them “I would make it a felony to drink small beer” and that all people would “worship me as their lord.”  To pull that off, his follower Dick told him that thinking they would have to do is “kill all the lawyers.”  

For the Past nine years these trial lawyers have been saying that the SSRI drugs do trigger suicidality, and, in some cases, homicidality, for a “small vulnerable subpopulation” of patients.  We have been seeking justice for the victims’ families.  Big Pharma, and especially Pfizer, has fought us every step of the way.  Even after a Wyoming jury concluded on June 6, 2001, that the SSRI drug “Paxil can cause some people to become homicidal and/or suicidal,” Pfizer continued to argue that Zoloft was totally safe for all people.  It continued to market Zoloft for use in children.  

On Tuesday, September 14, 2004, Pfizer finally lost the war.  Rejecting Pfizer’s strained data interpretations and strenuous arguments, Dr. Robert Temple of the FDA plainly stated that “causality has been established,” and the two combined FDA Advisory Committees voted 15:8 in favor of black box warnings about the increased risk of suicide for kids taking Zoloft and its cousin drugs.  

The real irony, however, is that five days before, i.e., on September 9^th, Pfizer put out its own black box warning.  But it wasn’t warning the public; it was warning its own employees.  And it wasn’t warning about the dangers of Zoloft, it was warning about trial lawyers.  In this internal memorandum, Pfizer assured its employees that “each time” the FDA has looked into the issue, it “concluded that there was no scientific basis for a warning that SSRIs…. cause suicide.”  For further reassurance and emphasis, Pfizer answered the rhetorical question, “Why is all of this negative media attention flaring up?”  With bold print and a colored background, all inside a big black box, as follows:  

Much of the media attention around this issue is being fueled by a couple of contingent-fee personal injury lawyers who have filed numerous lawsuits against a number of SSRI manufacturers over the past decade.  

In addition to blaming trial lawyers, Pfizer’s Spin Doctors also used this highlighted format to make three other “sound bite” points that have been the mainstay of Big Pharma’s PR strategy on this issue for years: (1) it blamed the “disease” of “depression” for al of the suicidality, (2) it hid behind the FDA’s previous inactions on this issue, and (3) it touted Zoloft as the “number one doctor-trusted antidepressant.”  

Shame on Pfizer! People are dying because of its drug. But, instead of issuing warnings to protect the portion of the population which its own expert, Dr. J. John Mann described in three peer-reviewed articles as the “small vulnerable subpopulation” of patients at risk for SSRI-induced suicidality, the largest pharmaceutical company in the world has attacked those who would hold it accountable-- the trial lawyers and tried to scare the population and bully the regulators.  Thank God that the FDA has finally awoken and has concluded that “causality has been established.”  

                                                                                    Andy Vickery

                                                                                    September 21, 2004