10/29/2003

AN OPEN LETTER REGARDING THE FDA & MCA PAXIL-SUICIDE WARNINGS

--Andy Vickery

In the first version of this "Open Letter" I expressed three concerns about these initial rulings. One of these concerns was that the focus should be broadened from Paxil to include all of the SSRI drugs, including venlafaxine (Effexor). Two events since that date have validated that concern. First, on August 22, 2003, Wyeth, the maker of Effexor, issued a "Dear Doctor" letter in this country cautioning that this drug should not be given to children and adolescents because of the increased risk of hostility and suicidality. Second, yesterday (October 27, 2003), the FDA issued a "Public Health Advisory" concerning all of the SSRI drugs and increased reports or risks of suicide. It cautioned that, although the data "do not clearly establish an association between the use of these drugs and increased suicidal thoughts or actions," it is "not possible at this point to rule out an increased risk." The FDA has scheduled a meeting on February 2, 2004, to discuss the issue. In spite of the fact that the standard allotment of time per presenter is only five minutes, I plan on being there.

Meanwhile, in the UK, as a result of the MCA activity there, GSK issued two important documents. The first is a "Dear Doctor" letter, acknowledging the suicidality problem in children and adolescents. The second is a June 18, 2003,

"Dear Doctor" letter announcing forthcoming changes in the labeling for "Seroxat," the name under which Paxil is marketed in the UK. Significantly, under the section "does Seroxat cause side effects?" GSK has "updated the text to include akathisia."

Although there are several biologically plausible precursors of SSRI-induced violence/suicide, akathisia is the neurological condition which has been most implicated in the numerous scientific articles linking all of the SSRI drugs these violent acts. The June 2000 revisions to DSM-IV-TR, §333.99, state the relationships quite succinctly as follows:

"Serotonin-specific reuptake inhibitor antidepressant medications may produce akathisia" . . . "the subjective distress resulting from akathisia . . . may be associated with . . . irritability, aggression, or suicide attempts."

Prior to these revisions numerous world class experts, including Teicher & Cole, Mann & Kapur, Wirshing & Van Putten, and Dr. David Healy and his colleagues in the UK, had warned about the role of SSRI-induced akathisia in violence and suicide since the early 1990's. Moreover, an extensive 1997 review article by Pfizer’s own Dr. Roger Lane confirmed that this precursor to violence/suicide is caused by all of the SSRI drugs, including his company’s Zoloft. In spite of this wealth of information, however, the big drug companies continued to deny the causal relationship and to conceal evidence of same in unpublished data and in documents hidden from public scrutiny by means of "confidentiality" designations in civil litigation.

The FDA’s action came shortly after the two year anniversary of a federal jury verdict in our Tobin v. SmithKline Beecham case¹. After considering extensive evidence from both sides, the jury found that "Paxil can cause some people to become homicidal and/or suicidal" and that it caused a peaceful, family man named Donald Schell to shoot his wife, daughter, granddaughter, and then himself. See verdict at www.JusticeSeekers.com. The judge ruled that the verdict was supported by scientifically reliable, legally admissible evidence and entered a $6.4 million judgment for our clients.

The following PowerPoint slide was used in that trial to illustrate the relationship between SSRI-triggered akathisia and homicide/suicide, and the industry’s awareness of the "small vulnerable subpopulation" of patients who were at risk for such violence:

I have been litigating SSRI wrongful death cases since the summer of 1995 and have tried two of the three cases which have reached jury verdict in this country, including the Tobin case. Although I am pleased with the FDA’s belated action on this issue, I am extremely concerned about three issues. Briefly, they are

(1) the risk of SSRI-induced suicide affects both children and adults;

(2) although the MCA and FDA have focused on self-directed acts of violence, these drugs can also trigger aggressive acts towards other people; and

(3) the risk is a class-wide effect of all SSRI drugs.

As the Tobin case illustrates and as GSK’s new "Dear Doctor" letter implicitly confirms, Paxil can trigger violent and suicidal actions in both children and adults. The numerous articles on point include Dr. J. John Mann’s 1991 article alerting the profession to the possibilities of iatragenic suicide in a "small vulnerable subpopulation" of patients.² Later, as a paid expert witness for both Pfizer and SmithKline Beecham, Dr. Mann has confirmed that akathisia does increase the risk of suicidality. Thus, the distinction made in the FDA’s rulings between children and adults at risk for increased suicidality is both artificial and dangerous.

Similarly, many of the scientific articles, as well as a host of reported adverse events and UNreported and UNdisclosed internal documents show that patients who go wacko on these drugs frequently harm others in lieu of or in addition to themselves. Our cases have shown similar fact patterns. For example, Tim Tobin’s step-father, Donald Schell, shot the three women that he loved the most in the whole world before turning the gun on himself. Similarly, the patient in our recently filed case of Balas v. GlaxoSmithKline, posted at www.JusticeSeekers.com, shot an innocent co-ed before he took his own life.

Finally, there is little question about the fact that the dangers of violence and suicide are common to the entire class of SSRI drugs." This point is especially critical in view of the fact that both Prozac and Zoloft are being heavily prescribed to children in this country. Hopefully, the October 27^th Health Advisory will go a long way towards elevating awareness and concern among prescribing doctors with regard to all SSRI drugs.

Numerous sources document the class-wide nature of these problems. Donovan and colleagues published an epidemiological study in the year 2000. Both Lilly and SmithKline Beecham provided funding for the study. The study evaluated 2776 patients and calculated the risk of "deliberate self-harm" from the SSRI drugs as a class to be 5.5 times higher than the safest of the older, tried and true, tricyclic antidepressants. Table 3 of this paper, reproduced below, shows the comparisons and confirms that of all the Big Three SSRI’s, i.e., Prozac (fluoxetine), Zoloft (sertraline) and Paxil/Seroxat (paroxetine) increase this risk significantly. Interestingly, within the class of SSRI drugs, Prozac had the highest risk at 6.6x and Zoloft the second highest at 4.9x. The risk from Paxil was 4.0x.³

Although I have been widely quoted for my stance regarding individual clients’ cases, I have never disputed the fact that, when prescribed and monitored by the right doctor to treat the right condition in the right patient, these drugs can help and have helped a lot of people. However, I believe that physicians need to be warned about the fact that their patients may well be in the "small vulnerable subpopulation" of people whose lives might be endangered by violent reactions to the SSRIs. I have represented far too many families who have lost loved ones to SSRI-induced homicides and suicides and firmly believe that prominent warnings will save lives.

Those of us who have labored long and hard for many years to bring these matters to public attention are justifiably gratified by the recent regulatory developments and hopeful that continued scrutiny will cause expanded warnings concerning the matters addressed in this letter.

However, if I may pause for a moment, it is also especially important in this period of intense public and regulatory activity to understand that not every act of violence by a person taking an SSRI drug is necessarily triggered by the drug. Nor should every person whose life has been adversely affected while taking an SSRI drug consider litigation. See our long-standing Policy Statement Concerning SSRI Wrongful Death Litigation, posted at www.JusticeSeekers.com. I write these words of caution because, quite frankly, a small but vocal and highly visible few members of my own profession are frequently the first ones to jump on the band-wagon and encourage "mass tort" litigation and they sometimes do so with all the dignity of carnival hucksters. Such activities demean the profession,⁴ devalue the legitimate claims of my clients, and encourage false hopes in others.

The law holds a manufacturer responsible only if its drug is a "substantial factor" in the violence and if there are ways to discern and prove that relationship. One way is through analysis of the "template" or "signature" pattern of the phenomenon. In the early 1990's, Eli Lilly, the manufacturer of Prozac, discerned such a pattern in the reported Prozac suicides and identified four distinctive attributes of this puzzling paradox:

Signature Pattern of SSRI-Induced Suicidality

(1) the patients became suddenly suicidal, usually within the first 30 days of taking the drug or increasing their dose;

(2) the suicide attempts were all violent, even those by women;

(3) the patient’s actions before and during the suicidal act were obsessive or impulsive in nature; and

(4) the suicide was completely out of character, or "egodystonic."

Since the Tobin verdict, I have continued to carefully select and aggressively pursue serious and legitimate cases – usually those involving death or other permanent physical injuries – which either fall within this pattern or otherwise have compelling proof of a causal relationship. I will continue to do so. I can be reached toll free at 800-231-3359 or via email to andy@justiceseekers.com.

Sincerely,

Andy Vickery

JusticeSeekers.com (2003)

Donovan, et al, Deliberate self-harm and antidepressant drugs, British J. Psych. 2000 Dec; 177 (6): 551-56, table 3.

End Notes

1. The Tobin trial put much previously undisclosed information into the public domain and the jury's verdict alerted many conscientious people to the potential dangers of this class of medications. In Great Britain, where "direct-to-consumer" television ads for prescription medications are not permitted, the verdict spawned two significant BBC documentaries: Mind Games and The Secrets of Seroxat. These, too, increased public and governmental aware of the latent dangers

2. Mann and Kapur, The Emergence of Suicidal Ideation and Behavior During Antidepressant Pharmacotherapy, 48 Arch. Gen. Psych. 1027-33 (1991). Dr. Mann has served as a consultant for Eli Lilly and as a paid litigation expert witness for both Pfizer and SmithKline Beecham.

3. Donovan, et al, Deliberate self-harm and antidepressant drugs, British J. Psych. 2000 Dec; 177 (6): 551-56, table 3.

4. The popularity of John Grisham's latest, King of Torts, demonstrates the continued public attraction of lawyer bashing and, sadly, documents how some lawyers bring such legitimate criticisms on all of us. Grisham's protagonist never once does anything that is in the best interests of his clients. I am proud to be a trial lawyer and to represent people with legitimate claims. And I am especially proud of the role that our litigation has played in bringing the dangers of SSRI drugs into public scrutiny.