Peter R. Breggin, M.D.
101 East State Street, No. 112
Ithaca, New York 14850
May 3, 2017
I affirm under the penalty of perjury the following:
(1) My name is Peter R. Breggin, MD and I am a physician licensed to practice medicine in New York State.
(2) I am a psychiatrist and maintain a clinical practice of psychiatry in New York State.
(3) I have reviewed the affidavit of Edward M. Bednarczyk, Pharm. D. and I offer my statement in response to his affidavit.
I. Concerning Suicidality Caused by Paxil
In sections (9), (11) and elsewhere in his affidavit, Bednarczyk states or implies that antidepressants, and Paxil (paroxetine) in particular, are not associated with not associated with suicidal impulses, thoughts or behaviors in adults. I will succinctly review evidence (A) that Paxil in particular is known to cause suicidal impulses, thoughts and behavior in adults; (B) that the newer antidepressants, such as Prozac, Paxil, Zoloft, and Effexor, are known as a group to cause suicidal impulses, thoughts and behavior in adults, and (C) that Paxil produces especially severe withdrawal reactions that are associated with depression, anxiety and suicidality, again in adults.
A. Paxil-Induced Suicidal Impulses, Thoughts and Behaviors
The attached PDFs numbered 1 through 11 deal with the specific subject of Paxil-induced suicidal impulses, thoughts and behaviors. Attachment 1 is excerpted from a very large study completed by Stones and Jones in 2006 for the Food and Drug Administration in which they found that Paxil was the only newer antidepressant causally associated with suicide. The excerpt shows the table comparing the finding for statistical significance for all the drugs in respect to causing suicidal impulses, thoughts and behavior, and only Paxil was statistically significant. This led the FDA to mandate that GSK, the manufacturer of Paxil, send a letter to America’s Healthcare Providers (Attachment 2) that included a warning that Paxil caused a suicidal risk in adult patients with Major Depressive Disorder, which characterizes Mr. Joseph Mazella.
There are two other compelling studies by Aursnes et al. of suicide attempts in controlled clinical trials involving Paxil (Attachments 3 and 4). As a medical expert in a product liability suit involving Paxil and suicide, I was empowered to evaluate proprietary materials owned by GSK in respect to Paxil-induced suicide and suicide attempts, and eventually was able to publish three scientific articles based on my examination of the company records, showing that the company was withholding or misrepresenting data (Attachments 5, 6 and 7). Other large-scale epidemiological studies involving antidepressants, always including Paxil, have also found a causal association between antidepressants, including Paxil, and suicidal impulses, thoughts or behaviors (Attachments 8-11). One study of controlled clinical trials involving normal volunteers also demonstrated that antidepressants, including Paxil, frequently cause activation (over-stimulation) symptoms, which are precursors to suicidal impulses, thoughts and behaviors (Attachment 9).
B. Antidepressant-Induced Suicidal Impulses, Thoughts and Behaviors in Other Studies of Paxil-like Drugs
It is generally agreed in psychopharmacology and psychiatry that the SSRI (selective serotonin reuptake inhibitor) antidepressants can be treated as a group. The Food and Drug Administration (FDA), for example, has class warnings that pertain to the entire group in each SSRI antidepressant’s Full Prescribing Information (the label or insert). All textbooks of psychiatry and pharmacology also treat them as a group in respect to adverse effects relating to behavior. Attachments 12-21 deal with the broader subject of SSRI antidepressants and suicidality, which was recognized as a serious problem as far back as Lancet editorial in 1990 (Attachment 12). Very compelling reports and reviews came out in the early 1990s (Attachments 13, 14 & 15), along with an epidemiological study in 2010 (Attachment 20). I have written many articles in which I review the subject of antidepressant-induced suicide and violence, bolstered with many scientific citations (as a sample, Attachments 16-19 and 21).
C. Paxil Withdrawal and Suicidal Impulses, Thoughts and Behaviors
Mr. Mazella was exposed to Paxil for many years, including a final stretch of approximately 11 years prior to his suicide, after which he was withdrawn the drug. He was thus exposed long-term to potential toxicity which could still be impacting Mr. Mazella a month or more later, plus he was in withdrawal, which itself is a risk for suicide. For this section, I have selected scientific reports which include Paxil and which document an increased risk of suicidal impulses, thoughts or behaviors during withdrawal (Attachments 22-27).
II. Concerning Harm from Long-Term Exposure to Antidepressants, including Paxil
Bednarczyk writes as if there is no evidence for long-term harm from SSRI-antidepressants, including Paxil. Here is a sample of scientific studies finding a variety of harms from long-term exposure to antidepressants, including a general worsening of the individual’s condition with apathy, depression, and a general worsening of the quality of life (28-33).
III Concerning Whether or Not SSRI Suicides are Especially Violent in Nature
In section (9), Bednarczyk states that there is no evidence or professional opinion that SSRI antidepressants cause especially violent suicides. My clinical experience with SSRI-induced suicides is very extensive. In my clinical and forensic work, I am probably in the top three most-experienced in this field, and have written about the subject as much or more than any other professional. In one of my early books, Talking Back to Prozac (2004, coauthored with G. Breggin), I described numerous cases of especially violent suicides on Prozac. In one of my more recent books, Medication Madness: The Role of Psychiatric Drugs in Suicide, Violence and Crime, I again discussed the special violence of SSRI-induced suicides, drawing on dozens of cases presented in the book. I suspect my extensive clinical experience in itself is sufficient for me to make this clinical observation in a courtroom.
In addition, there is confirmatory research and clinical reports confirming the especially violent nature of SSRI-induced suicidal behavior (34-37). An experienced research team writing in the American Journal of Psychiatry reported (37):
Spectrum of Suicide
We examined the association between antidepressant use and method of suicide, since some reports have linked SSRI antidepressants with especially violent suicidal ideation (15, 39). Relative to other antidepressants, SSRIs were more strongly associated with suicides of a violent nature (hanging, gunshot, jumping, stabbing, vehicle collision, blunt trauma, explosion, electrocution, and self-immolation) than other antidepressants (Figure 3). [2006, p. 816; bold added]
Mr. Mazella died horrendously by multiple self-inflicted “stabbing.”
IV. Concerning Dr. Bednarczyk’s Report More Generally
While attempting to criticize me on scientific grounds, Edward Bednarczyk, Pharm D does not rely on scientific citations. I could not find a single scientific reference for his broad generalizations or for his specific allegations. This leaves us to rely upon his wholly undocumented opinions.
Upon what clinical and professional background does Bednarczyk base these opinions? Bednarczyk was trained as a pharmacist rather than as a physician and psychiatrist. His Pharm D degree is a prerequisite for becoming a licensed pharmacist. Bednarczyk is not a clinician, so he lacks clinical experience. He does not provide a single publication of his own and presumably has not published relevant research or clinical reports.
Because he is qualified as a pharmacist, he does not have authority to prescribe medications or to treat patients, and would not be in a position to evaluate the current state of psychiatric theory and practice. Nor is he a psychopharmacologist—that is, someone trained, experienced or published in the science of how medications affect the brain and behavior, and would not have the credentials of a scientist in the area.
In contrast, this expert has been approved in state and federal courts dozens of times as an expert in psychiatry, psychiatric drugs, and psychopharmacology. Please see my appended Resume which concludes in the final section with a list of more than 90 cases since 1985 in which I have been approved to testify in state and federal courts, mostly concerning issues related to the subjects of this case—suicide, violence and other harms caused by antidepressants. I have written more than twenty professional books, most of them dealing with the adverse effects of psychiatric medications, and more than 50 scientific peer-reviewed articles, most of them relevant to this case (see my Resume for books and articles). As my resume will also demonstrate, I have presented or testified on matters related to antidepressant suicide before the U.S. Congress, numerous federal agencies, and innumerable professional conferences. I have also been a scientific and legal consultant to the Federal Aviation Agency (FAA) on the topic of the effect of SSRI antidepressants upon pilot safety.