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Designing proper testing for antidepressant-generated suicidal
ideation in adults
Jeanne Lenzer's Dubious Choices in Experts
Mud splatters
Re: Mud splatters
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| Steven Steinberg, Journalist NYC, NY (11374) Send response to journal: |
Dear BMJ, It has long struck me as disturbingly inconsistent that while the potential for suicidal effects of anti-depressants were being examined, within the FDA, in regard to children and young adults, no such FDA examination appeared to be underway or forthcoming (at least as far as I know) in regard to any potential for these same anti-depressant drugs to generate or heighten suicidal ideation in adult users of these same drugs. In my view, it was as though the FDA were saying, by not addressing (publicly at least) this issue, that young persons might be at risk but that, at the same time, adults need not be concerned -- and that it was therefore permissible for adults to continue to be (a) targeted by media adverts promoting the adult-use of those same drugs and (b) be prescribed those same drugs by their doctors, as though any possible suicidal- ideation-generating qualities of those drugs, which might possibly affect children and young adults, would not possibly affect older adults. I am not a medical professional, so my thoughts here may be entirely wrong. But I will say that there just seemed to me to be a puzzling -- and concerning --inconsistency in the above regard. Thus it is heartening to know that the FDA, as Ms. Lenzer points out in her BMJ article, is now planning to examine whether there are any possible suicidal-ideation-enhancing effects of such anti-depressant-drugs on adults. But I am curious to know why it took so long to reach this point. Further, it is, as per my understanding, a basic tenet of medicine that as the human body ages, from one stage of life to another, the body's physiological needs and ability to process and respond to various medications significantly changes from stage to stage. Thus, what may be an appropriate medication, or dose of medication, for a child, may be different from that which is acceptable to the physiological condition of a young adult, which in turn differs from that which is acceptable to the physiological condition of a middle-aged adult, which in turn may be significantly different from that which is safely processable by the physiological parameters of an elderly person. And between males versus females. And so on. Thus, my point in making these elementary distinctions is this: Is the FDA, in its announced upcoming analysis of the possible suicidal effects of anti-depressants on adults, going to be taking into account, in this study, the varying physiological differentiations and responses between adult age-groups as well as between the sexes, and will it then be analyzing the results according to those parameters? Too, if such differentiations, in the design of this study and the analysis of its results, will be considered, I would hope too that additional potentially influential parameters will also be taken into account in the study's design. Specifically, what I have in mind here, in part, is the fact that elderly adults typically take (or are given) more medications -- and a wider range of medications -- than are most younger persons; and against this "backdrop" of medications, one wonders if the administration of an anti-depressant drug may take on a greater effect on the elderly person than would that drug if that "backdrop" of other medications were not part of the picture. So will this consideration be taken into account? I would hope, too, that any study of the possible suicidal-ideation- enhancing effects of anti-depressant drugs on the elderly would also be based on truly accurate and properly comprehensive data. Specifically, with this statement, I am referring to the issue of whether or not, when a suicidally depressed elderly person -- perhaps already in a hospital or old age home setting -- succeeds in intentionally removing himself or herself from this life, this individual's passing is noted as having possibly been an effect of the anti-depressant drug -- or is instead considered just part of the "natural" (even if medically or conditionally caused) chain of events, with the anti-depressant drug's possible participation in the event belittled or ignored and thus not tracked. If the latter is the common case, the difficult question arises: How then might the study, regarding the drug's effects on the elderly, be considered fully comprehensive and accurate, or at least somehow be rationally adjusted to "compensate" for this partial lack of important data? It would seem to me that this may be a difficult study. On a difficult and eminently sad subject too. But, in my opinion, it is long overdue -- and offers the potential, if properly done, of helping save lives at any age. One would hope, in any case, that those conducting this study devote their best efforts to doing an accurate, honest, outstanding job -- and that their findings are released as soon as possible, as minds and lives may hang in the balance. -- Steven Steinberg NYC, NY 10-07-04. Competing interests: None declared | |||
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| James C. Coyne, Professor of Psychology in Psychiatry Univerisity of Pennsylvania, Philadelphia, PA 19104 Send response to journal: |
In a series of news articles, Ms. Jeanne Lenzer has distorted important issues concerning the efficacy and safety of treatments for depression, by invoking experts of dubious credentials but consistent bias. (Coyne, 2004, http://bmj.com/cgi/eletters/329/7465/529#73994). This week, Ms Lenzer has again relied on Dr. Peter Breggin as authority. Just who is Dr. Breggin? Ms. Lenzer describes Breggin as a "psychiatrist and clinical psychopharmacologist". However, Breggin lacks board certification as a psychiatrist and neither prescribes psychotropic medication nor does empirical research in pharmacology (http://www.quackwatch.org/04ConsumerEducation/NegativeBR/breggin.html). My personal search for Breggin today in Institute for Scientific Information Science Citations reveals 36 entries, 23 of which are letters to the editors, and there are no apparent instances of empirical research. In Your Drug May Be Your Problem Breggin and his co-author Cohen make no exceptions in denouncing psychotropic medication, and urge patients to stop their medication because "When we take drugs to ease our suffering, we stifle our psychological and spiritual energy"(1999, p3). Breggin's resume lists serving as an expert witness in "approximately 40 cases" including in cases of criminal assault and murder in which he argues for use of antidepressants as a defense (http://www.breggin.com/resume.html). According to Forbes Magazine, Breggin testifies against psychotropic medication for an average $350 an hour, plus $3,500 a day for trials or depositions (http://www.forbes.com/forbes/2001/0723/060.html). Breggin has had his expertise repeatedly rejected in legal proceedings (http://www.quackwatch.org/11Ind/breggin.html). For instance, Judge James W. Rice ruled "Dr. Breggin's observations are totally without credibility. I can almost declare him, I guess from statements that floor me, to say the he's a fraud or at least approaching that." In another case, Judge Hilary J. Caplan ruled "The court believes not only is this gentleman unqualified to render the opinions that he did, I believe that his bias in this case is blinding." Ms. Lenzer has made much in the past of journalists allegedly failing to identify the biases of those they present as experts and their hiding these sources' financial interests. Might she be guilty of failing to disclose her own biases? Competing interests: None declared | |||
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| Jeanne Lenzer, medical investigative journalist Kingston, NY 12401 USA Send response to journal: |
James C. Coyne states that I ?distorted important issues concerning the efficacy and safety of treatments for depression, by invoking experts of dubious credentials but consistent bias,? yet he fails to point out one single alleged ?distortion? in my article. Professor Coyne instead substitutes an attack on one of my sources, Dr Peter Breggin, for any argument about the issues raised by my article. This has been a tack of Dr Coyne?s in the past. He slings mud at any number of scientists who provide critical data and analyses regarding the relative safety and efficacy of antidepressants: http://bmj.bmjjournals.com/cgi/eletters/329/7465/529#73994 . As a journalist I select sources with some care. That does not mean that I agree with or embrace everything about my sources. That would be impossible since I generally quote sources who are usually at odds with each other. Indeed, Professor Coyne has written an important critique of screening for depression that is well argued and well documented http://bmj.bmjjournals.com/cgi/content/full/323/7305/167/b . For that reason, I might find it useful in the future to cite his article and work. Dr Coyne suggests I am biased for using Dr Breggin as a source. Yet Prof Coyne has responded to two recent articles I?ve written by attacking the reputation and credibility only of those sources who raise concerns about the safety and efficacy of antidepressants. As for the specifics of Dr Breggin?s credentials to comment I would like to reiterate what I said in another response to an attack on him: Dr Breggin sounded the warning bell about tardive dyskinsias in children caused by neuroleptics at a time when others sniffed at the idea ? yet his insights are now widely accepted. Dr Breggin also started warning ten years ago that antidepressants might be related to increased risks of suicide and aggression in children ? something that has just recently been validated by an advisory panel to the US Food and Drug administration. Given the prescience of his warnings it seems to me that bringing a source like Dr Breggin to the attention of readers is a public service. Dr Breggin, an honors graduate of Harvard, has served as a consultant to the National Institutes of Health and has published some 30 peer- reviewed articles and a number of books. He may not arrive at the same conclusions that Dr Coyne would appear to approve but his credentials certainly rise to the level of having the right to state his informed opinion of the topic. Finally, Dr Coyne quotes Stephen Barrett twice in his letter to suggest that Dr Breggin is a fraud or ?near fraud? and offers as part of his damning evidence that Dr Breggin is not board-certified. It is indeed true that Dr Breggin is not board certified in psychiatry, as is the case for over one-half of the graduates of his generation. Indeed, neither is Dr Coyne?s expert source, Dr Barrett, board certified. Would Dr Coyne like to withdraw his use of Dr Barrett on that basis? It is rather ironic that in an email to me confirming that he is not board certified, Dr Barrett wrote, ?what you should be looking at is whether or not people's ideas are supported by logic and evidence? ? advice Prof Coyne might like to heed. Jeanne Lenzer Competing interests: author of the article | |||
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| Peter R Breggin, Psychiatrist 14850 Send response to journal: |
Dr. Peter Breggin Responds to Criticism In recent letters to the BMJ, two colleagues have directed criticisms at reporter Jeanne Lenzer for citing me as an expert. These attacks are generated by my participation in recent successful attempts to convince the FDA to warn about antidepressant-induced suicidality in children, a concern I have voiced and documented for the past decade. Psychiatrists who conduct independent evaluations of medications or who criticize the pharmaceutical industry often come under attack. Jon Jureidini (1), Joseph Glenmullen (2), David Healy (3) and the recently deceased Loren Mosher (4) are among those who have been unfairly criticized. Even journalists like Robert Whitaker are not immune (5). It is important for me as an independent psychiatrist and clinical psychopharmacologist to reaffirm my credentials. In addition, the following summary of my professional background may help to explain why Ms. Lenzer turned to me as an expert on the subject of adverse drug effects. Contrary to psychologist James Coyne?s assertion, I do prescribe psychiatric medication. My objections to the overuse of medication are based on medical and scientific conclusions that I document in many of my nineteen books and thirty-plus peer-reviewed articles. My publications in clinical psychopharmacology include peer-reviewed reports and reviews (6- 21) and professional books (22-30). Indeed, I began publishing peer- reviewed papers on adrenaline and the psychophysiology of anxiety forty years ago (6, 7). In 1983 I wrote Psychiatric Drugs, a medical book that contained the most in depth analysis to date of the risk of tardive dyskinesia in children and tardive dementia in children and adults. That publication and my educational efforts resulted in the FDA requiring the 1985 expanded class label for tardive dyskinesia for all neuroleptics. Several of my books have documented that SSRIs produce a continuum of stimulation or activation that can result in violence and suicide (24, 27, 29, 30). Two of my recent peer-reviewed analyses describe in detail the stimulant continuum and the risks of suicide and violence (18, 20). In 2003-2004 I wrote, ?Mania with psychosis is the extreme end of a stimulant continuum that often begins with lesser degrees of insomnia, nervousness, anxiety, hyperactivity and irritability and then progresses toward more severe agitation, aggression, and varying degrees of mania (20, p. 32). In similar language, the FDA recently concluded that the behaviors ?known? to be associated with SSRIs include ?anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania and mania? (31). The basic language adopted by the FDA is very close to that in my publications and my presentations to the agency. Even more recently, the FDA has confirmed my decade-long position that the newer antidepressants cause suicidal ideation and behavior in children. There is also evidence that they cause suicide in adults (20, 24). Again contrary to the criticism, my expertise has been frequently affirmed by courts in the United States and Canada (more than 70 times in the last 20 years, often in regard to psychopharmacology). In 1973 I was the medical expert in Kaimowitz v. Department of Mental Health in Michigan that stopped the resurgence of psychosurgery in state mental hospitals in the United States, as well as in all federal and many private facilities. My efforts also slowed down the return of psychosurgery in Canada and Europe. In the early 1990s I was appointed the scientific and medical expert for the several hundred combined Prozac suits. The drug company, Eli Lilly, has settled all of the many suits in which I have participated as a medical and scientific expert. In 2000 I was the medical consultant in a suit against the manufacturer of Paxil that was resolved in association with the drug company?s decision to upgrade its warnings about withdrawal reactions caused by Paxil. Dr. Coyne cited two relatively old cases in which judges criticized me. In a 1997 family court case I testified against a parent who insisted on medicating her child with Ritalin. That parent also happened to be a judge in the same court in which the case was being tried. Obviously, I took a professional risk in testifying against a judge in her own court system (see 25, chapter 7, for a description of the trial). The negative result did not blemish my credentials. In the following year, the National Institutes of Health (NIH) selected me to be the scientific expert on adverse drugs effects in children at the 1998 Consensus Development Conference on the Diagnosis and Treatment of ADHD. In the other case, in 1995 a judge rejected my testimony that electroshock treatment causes harm to the brain. The judge resigned from the bench immediately after the conclusion of the case and went to work for the defense firm in the same case. The judge attacked my views on shock treatment despite the fact that I had written lengthy research documentation on the subject (32, 33) and despite NIH selecting me as the expert on brain neuropathology caused by ECT at the 1985 NIH Consensus Development Conference on Electroconvulsive Treatment (34). Dr. Nicholas DeMartinis? criticism of me has some similarities to Dr. Coyne?s. His accusation that I take a ?stance against all use of medications? is simply false. However, I have for many years documented scientifically that psychoactive substances, including psychiatric drugs, often do more harm than good. Patients frequently come to me for the purpose of evaluating adverse drug effects and to undergo a safe withdrawal. Meanwhile, as already noted, many of the concerns that I have raised about the risk/benefit ratio of psychiatric drugs have now been confirmed. Furthermore, my longstanding call for disclosures of conflicts of interest or ?competing interests? has now been generally accepted. In that regard, my own competing interests include the welfare of patients and the imperative, ?First, do no harm.? By contrast, Dr. DeMartinis must list nine drug company affiliations as his competing interests, surely a more onerous burden in regard to scientific objectivity. My medical and psychiatric background has also been challenged and so it?s necessary to summarize my credentials. I am a graduate of Harvard College (1954-1958) and Case Western Reserve School of Medicine (1958- 1962). My first year of psychiatric training was at the Massachusetts Mental Health Center where I was a teaching fellow at Harvard Medical School. My internship and second and third year of psychiatric training was at the State University of New York, Upstate Medical Center. Following the completion of my psychiatric training, I was appointed a full-time consultant with the National Institute of Mental Health (NIMH) for two years. After that, I went into fulltime private practice in 1968. I am a Life Member of the American Psychiatric Association and also belong to the Canadian Psychiatric Association, the Royal Society of Medicine (psychiatry) and other professional and scientific organizations. I have taught at several universities and frequently have been asked to address international professional meetings and CME credit seminars on the subject of psychopharmacology. My complete resume can be found on my website (www.Breggin.com). Drs. Coyle and DeMartinis have presented the kind of distortions typically found in pharmaceutical industry attacks against independent experts in clinical psychopharmacology and psychiatry. With the recent decisions of the CSM and the FDA in support of positions I have taken for ten years, these attacks are heating up. I appreciate the opportunity to have answered them. Peter R. Breggin, M.D., Founder and Director Emeritus of the International Center for the Study of Psychiatry and Psychology. Correspondence: 101 East State Street, No. 112, Ithaca, New York 14850, USA. 1. Jureidini, J., Doecke, C., Mansfield, P., Haby, M., Menkes, D., and Tonkin A. Efficacy and safety of antidepressants for children and adolescents. British Medical Journal 2004; 328: 879-883. 2. Glenmullen, J. Prozac backlash. Simon and Schuster: New York, 2000. 3. Healy, D. Lines of evidence on the risks of suicide with selective serotonin reuptake inhibitors. Psychotherapy and Psychosomatics 2003; 72: 71-79. 4. Lenzer, J. Obituary: Loren Mosher?psychiatrist who espoused drug- free treatment for schizophrenia. British Medical Journal 2004; 329: 463. 5. Whitaker, R. Mad in America: bad science, bad medicine, and the enduring mistreatment of the mentally ill. Perseus Books: Cambridge, MA, 2002. 6. Breggin P. The psychophysiology of anxiety. Journal of Nervous Mental Diseases 1964; 39: 558-568. 7. Breggin P. The sedative-like effect of epinephrine. Archives of General Psychiatry 1965; 12: 255-259. 8. Breggin P. Brain damage, dementia and persistent cognitive dysfunction associated with neuroleptic drugs: evidence, etiology, implications. Journal of Mind Behavior 1990; 11:425-464. 9. Breggin P. Psychotherapy in the shadow of the Psycho- Pharmaceutical Complex. Voices 1991; 27:15-21. 10. Breggin P. A case of fluoxetine-induced stimulant side effects with suicidal ideation associated with a possible withdrawal syndrome ("crashing")." International Journal of Risk & Safety in Medicine 1992; 3:325-328. 11. Breggin P. Parallels between neuroleptic effects and lethargic encephalitis: the production of dyskinesias and cognitive disorders." Brain and Cognition 1993; 23:8-27. 12. Breggin P. Should the use of neuroleptics be severely limited?" Changes: An International Journal of Psychology and Psychotherapy 1996; 14: 62-66. 13. Breggin P. Analysis of Adverse Behavioral Effects of Benzodiazepines with a Discussion of Drawing Scientific Conclusions from the FDA's Spontaneous Reporting System." Journal of Mind and Behavior 19:21-50, 1998. 14. Breggin P. Psychostimulants in the treatment of children diagnosed with ADHD: part I?acute risks and psychological effects. Ethical Human Sciences and Services 1:13-33, 1999. 15. Breggin P. Psychostimulants in the treatment of children diagnosed with ADHD: part II?adverse effects on brain and behavior.? Ethical Human Sciences and Services 1:213-241, 1999. 16. Breggin P. What psychologists and psychotherapists need to know about ADHD and stimulants. Changes: An International Journal of Psychology and Psychotherapy 18:13-23, Spring 2000 17. Breggin P. The NIMH multimodal study of treatment for attention- deficit/hyperactivity disorder: a critical analysis. International Journal of Risk and Safety in Medicine 13:15-22, 2000 18. Breggin P. Fluvoxamine as a cause of stimulation, mania, and aggression with a critical analysis of the FDA-approved label. International Journal of Risk and Safety in Medicine, 14: 71-86, 2002. 19. Breggin P. Psychopharmacology and human values. Journal of Humanistic Psychology, 43: 34-49, 2003. 20. Breggin P. Suicidality, violence and mania caused by selective serotonin reuptake inhibitors (SSRIs): A review and analysis.? International Journal of Risk and Safety in Medicine, 16: 31-49, 2003/2004. 21. Breggin P. and Breggin G. The hazards of treating 'attention- deficit/hyperactivity disorder' with methylphenidate (Ritalin). Journal of College Student Psychotherapy 10:55-72, 1996. 22. Breggin P. Psychiatric drugs: hazards to the Brain. Springer Publishing Company: New York, 1983. 23. Breggin P. Toxic psychiatry. St. Martin's Press: New York, 1991. 24. Breggin P. Brain-disabling treatments in psychiatry: drugs, electroshock and the role of the FDA. Springer Publishing Company, New York, 1997. 25. Breggin P. Talking back to Ritalin. Common Courage Press: Maine, 1998. 26. Breggin P. Talking back to Ritalin, revised edition. Perseus Books: Cambridge, MA, 2001. 27. Breggin P. The antidepressant fact book. Perseus Books: Cambridge, MA, 2001. 28. Breggin P. The Ritalin fact book. Perseus Books: Cambridge, MA, 2002. 29. Breggin P and Breggin G. Talking back to Prozac. St. Martin's Press, New York, 1994. 30. Breggin P. and Cohen D. Your drug may be your problem: how and why to stop taking psychiatric medications. Perseus Books: Cambridge, MA, 1999. 31. FDA Talk Paper. FDA issues public health alert advisory on cautions for use of antidepressants in adults and children. March 22, 2004. www.fda.gov/bbs/topics/ANSWERS/2004/ANSO1283.HTML] 32. Breggin P. Electroshock: its brain-disabling effects. Springer Publishing Company: New York, 1979. 33. Breggin P. Electroshock: scientific, ethical, and political issues. International Journal of Risk & Safety In Medicine 1998; 11: 5-40. 34. Breggin P. Neuropathology and cognitive dysfunction from ECT. Psychopharmacology Bulletin 1986; 22: 476-479. Competing interests: None declared | |||
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