Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Suicidal behaviour is possible in depression
- Sergio A. Perez Barrero (7 August 2004)
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Check the stats
- B.N. Basinger (8 August 2004)
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Troubling: Suppression of Mosholder's Analysis
- S. J. Steinberg (9 August 2004)
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The real issue
- Kathy A D'Arcy (9 August 2004)
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Re: Check the stats
- Lindsay Geddes (9 August 2004)
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Antidepressants and suicide: an old controversy
- Dr.Naseem A. Qureshi MD, IMAPA, LMIPS (9 August 2004)
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No more secrets
- Toshi A. Furukawa (10 August 2004)
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Re: No more secrets
- Fred M. Sander (28 September 2004)
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Sergio A. Perez Barrero, Founder WPA Suicidology Section 85100
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Dear Jeanne: Depression is a most frequent disease found in suicidal people. The treatment of depression is antidepressive’s drugs, mainly ISRS actually, but in the past, others antidepressives were the main treatment of this condition. In the past, some research founded that imipramine and amitripitiline showed risk of suicidal behaviour in some individuals. In my point of view suicide is usual in depressive diseases in which the antidepressive’s drugs are used and then can appear suicidal tendencies during the treatment of these patients, neither mainly for de disease nor for the treatment. In other hand if the depression is severe, the motor component of behaviour improvement before that suicidal ideas, with serious danger for the patient life during this stage. Other problem would be if a normal people, without depression take in antidepressives drugs and they commit suicide, because is not frequent that general people commit suicide in absence of mental diseases. Sincerely yours Prof. Dr. Sergio A. Perez Barrero Founder WPA Suicidology Section IASP National Representative Competing interests: None declared |
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B.N. Basinger, decline 91701
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From the report: >> Dr Mosholder had evaluated data from 22 studies using nine drugs in 4250 children and found that 74 of the 2298 children taking antidepressants had a "suicide related event" compared with 34 of the 1952 children taking placebos.<< 74/2298 = 3.22 %. I wonder how many of these children would have had "suicide related events" even without the medication? 34/1952 = 1.74 %. They didn't get any medication Therefore it's probably safe to assume that about ˝ of the medication group would have had an "event" even without any medication. Competing interests: None declared |
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S. J. Steinberg, Journalist NYC, NY 11374
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Dear Sirs, Regarding BMJ's article "Secret US report surfaces on antidepressants in children" (BMJ 2004; 329: 307): What troubles me is the fact that, according to the article, Dr. Mosholder was blocked by higher-ups at the FDA from publicly revealing his study's conclusions -- which raises serious questions about the FDA's modus operandi -- and that for the additional months that ensued until the controversy finally emerged into public light, the drugs in question (which Dr. Mosholder had found may in some cases contribute to suicidal tendencies) were permitted to remain on the market and to be prescribed to the very people that, if Dr. Mosholder's conclusions were accurate, might consequently be placed at increased risk of committing suicide. That the FDA officialdom asserted that Dr. Mosholder's conclusions were premature or perhaps incomplete or inaccurate, and that therefore he should be blocked from revealing his findings on the matter, is, in my opinion, both improper and worrisome: this action by the FDA not only served to intentionally suppress information that by rights should have been made available to the medical & pyschiatric community (as well as to the public) -- even if, at the least, for debate -- but it also raises the question of how many other such cases of muzzling a researcher may have occurred, or perhaps might yet occur, within the FDA. If Dr. Mosholder's analysis was truly faulty, where then was the countervailing analysis, and why was that not presented as well? Why did we have to await journalistic pursuit of the matter in order to bring -- months later -- the issue to light and to generate a debatable rationale from the FDA as to why it chose to block Dr. Mosholder from conveying his views? Even as the BMJ article (and some rapid responses) notes, there are differing views as to the interpretation of Dr. Mosholder's study -- which, it would also seem to me, is often the case in any thorough analysis of a given study's methods of analysis. Would it not have been legitimate, and wiser, to have permitted Dr. Mosholder to speak freely about his findings, and for an open debate as to the accuracy or inaccuracy of his findings to have been pursued? What will be, I wonder, the FDA's policy as to how to handle future such instances when other "Dr. Mosholders" generate a significant analysis of an important issue and wish to speak freely of their findings? -- S. J. Steinberg NYC, NY Competing interests: None declared |
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Kathy A D'Arcy, SHO Cork, Ireland
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I think the real issue here is not whether antidepressants cause more suicidal events in children, but whether the FDA is willing to approve medication for public consumption when serious questions are being raised by its own specialists regarding the drug's safety - and if so, what kind of watchdog organisation or legislation could safeguard against this. Competing interests: None declared |
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Lindsay Geddes, management consultant Not available
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Let's take the stats a step further. 3.22% of kids on the antidepressants suffering some kind of suicide-related event is 85% more than the 1.74% of kids on placebos. Does some kids suffering these events, because they might anyway, make it okay that almost twice as many suffered them when given the drugs? Almost twice as many is almost a 100% increase, meaning a lot more children in worse trouble than they were before. It was unclear whether you were saying the numbers are okay, ie. that it's all right for more kids to have suicide-related events with the drugs than without them. Or were you suggesting that it's okay for less-than- positive data and conclusions to be kept under wraps? Competing interests: None declared |
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Dr.Naseem A. Qureshi MD, IMAPA, LMIPS, Medical Director(A), Director CME&R Buraidah Mental Health Hospital, Postcode:2292, Saudi Arabia
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Sir: Notably, the list of psychiatric and non-psychiatric disorders as regards suicide is ever increasing. However, depression is still the best predictor of suicide among psychiatric population. More worse is the case when depression is complicated by other psychiatric disorders such as panic or drug abuse or personality disorders, and psychotic symptoms, lack of psychosocial networks, and neurological and medical disorders. Moreover, suicidal ideations may emerge either during initial prodromal phase, or active phase or post-treatment phase of depression. Even stable patient with treated depression may have suicide tendencies. The usual treatment of depression or co-morbid depression is antideperessants-traditional or SSRIs plus adjunctive psychotherapy. When patients is on one of the drugs and develop suicidality, it is not easy to attribute this emerging suicidal behavior exclusively to antidepressant drugs. Antidepressants drug trials never match the real life situations of the people with depression, whether the population includes children and adolescents, adults or elderly people. The issue of not disclosing relevant data by FDA or other data protecting agencies which could have warned the prescribers of nine antidepressants in children and adolescents with depression and emerging suicidal communication among them is debatable. The disclosure of such data is justified only if it is not premature and at the same time enhances the public safety. Refrenece: Jeanne Lenzer. Secret US report surfaces on antidepressants in children. BMJ 2004; 329: 307 Competing interests: None declared |
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Toshi A. Furukawa, Professor Dept Psychiatry, Nagoya City University Med School, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN
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Sir: Lenzner (1) recently reported that the US Food and Drug Administration (FDA) had prevented an internal report on increased suicidality among children on serotonin reuptake inhibitors from becoming public in February 2004. This is very alarming to the medical community because it is usually only the regulatory agencies such as the FDA which have full access to clinical trials data submitted from pharmaceutical companies. The situation, however, is now different with regard to paroxetine. Full reports of its clinical trials are publicly available on the internet, and we can now critically examine on our own the three trials (study 329, study 377 and study 701) that GSK has to date conducted in paediatric and adolescent major depression. As I read their reports, I was alarmed by three unmistakable facts that emerged. 1) What the company calls gemotional lability, explained as crying, mood fluctuations, hostility, self-harm, suicidal thoughts and attempted suicide is none other than suicidal tendencies. Crying and mood fluctuations may be there but the case descriptions clearly indicate that the reports did not label the symptoms emotional lability unless there was suicidality. 2) Two cases of suicidal tendencies were not counted as those with emotional lability. In study 329, one patient was treated as a case of aggression but not of emotional lability. According to the report, however, this 14-year-old male patient had been on paroxetine for 14 days, when he became very angry. He punched pictures, broke glass, and sustained lacerations that required six sutures. His anger subsided, but he expressed hopelessness and possible suicide thoughts. The patient was hospitalized due to his severe anger outburst and a worsening of his depression. In study 701, an 11-year-old male with the following clinical course was counted as a case of acute exacerbation of depression but not of emotional lability; He was randomized to paroxetine and was titrated up to 30 mg per day. The patient stopped taking study medication on Day 28; no reason has been provided. Two days later, the patient threatened to harm himself and was hospitalized with an acute exacerbation of major depressive disorder. 3) Taking all these cases of suicidal tendencies into account, the pooled odds ratio for suicidality on paroxetine in comparison with placebo is 2.77 (fixed effect model 95%CI: 1.03 to 7.41). The effect size is large and no heterogeneity is present. There is one clear lesson to be learned here. All clinical trials, not only those conduced by drug companies but all the others included, must be reported in details and made publicly available as reasonably soon as possible. Without such policy internationally, neither healthcare professionals nor consumers can ever make sufficiently informed decisions. 1 Lenzer J. Secret US report surfaces on antidepressants in children. BMJ 2004; 329: 307 2. GlaxoSmithKline Media Room http://www.gsk.com/media/paroxetine.htm (accessed 17 July 2004) Competing interests: I have received research grants and fees for speaking from some pharmaceutical companies, which market antidepressants (paroxetine, fluvoxamine, milnacipran, trazodone, mianserin), antipsychotics (risperidone, olanzapine, quetiapine), nootropics (donepezil) and anxiolytics (loflazepate). |
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Fred M. Sander, Associate Clinical Professor of Psychiatry; Weill-Cornell Medical School 200 East 89th St. 10G NY, NY 10128
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Family psychiatry is barely taught in medical centers, so it is no surprise that this modality is not included in most clinical outcome studies recently cited in the press. In the area of depression in children and adolescents the bio- psycho-social model is especially relevant, yet the comparison studies of medication, individual psychotherapy, placebo, CBT and their combinations, rarely include the study and treatment of family processes. Family circumstances are almost always at play in children and adolescents suffering depression. Our classical literature (Shakespeare's "Hamlet") and popular culture ("Ordinary People" & "Traffic") recognize this. Not infrequently a suicidal adolescent will acknowledge the pleasure he would get from the pain his suicide would inflict on the parents. There is also clinical evidence that suicide may be associated with death wishes from the family. (Rosenbaum, M. and Richman, J. 1970) The concurrent individual and family treatment deserves consideration as does the concurrent use of anti-depressants and individual treatment (Sander,F. and Feldman, L., 1993). It is no secret that psychiatry, for the most part, ignores the family. Perhaps a DSM V will include "relational disorders." (First, et.al, 2002) Until then it is left to the better pharmacologic financed or "cost effective" CBT modalities to debate the fine points of clinical treatments while ignoring a major determinant in all too many cases. Rosenbaum, M. and Richman J. (1970) The role of hostility and death wishes from the family and significant others. Am.J. Psych. 126:1652-1655. Sander, F.M. and Feldman, L. (1993) Integrating Individual, Marital and Family Therapy in Review of Psychiatry ed. By J. Oldham et al. Washington, D.C.: American Psychiatric Press. First, M.B. et.al. Personality Disorders and Relational Disorders. (2002) In Kupfer, D.J., First, M.B., Regier, D.A., (eds.) A Research Agenda for DSM V Washington, D.C.: American Psychiatric Press. Competing interests: Author is teacher and writer in the field of family psychiatry. |
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