End Of Antidepressants? - 68
Times Greater Suicide Risk Shown!
Dr. Ann Blake Tracy
Executive Director International Coalition for Drug Awareness
First we had the thalidomide tragedy, the fen-phen fiasco, even LSD and PCP as prescription drugs, yet none of them begins to compare with this. Never in the history of the FDA do I recall something as tragic or terrible or as shocking or as criminal as this revelation is! Mass murder by prescription is the only expression that fits.
Blockbuster Study - 68 Times Greater Suicide Risk With Serotonergic Meds!
New research presented at a recent NIH sponsored meeting demonstrates a 68 times greater risk of suicide with the new serotonergic antidepressants and antipsychotics than if a patient never took anything.
These shocking figures of increased risk shows that a patient's chances of suicide jump from 11 out of 100,000 to as much as 718 out of 100,000 if one is taking one of these new SSRI antidepressants (Prozac, Zoloft, Paxil, Luvox, Celexa) - medications touted to alleviate depressive symptoms and rid one of suicidal tendencies. And the risk is even higher for the new serotonergic antipsychotics (Zyprexa, Risperal, Seroquel) - 752 out of 100,000.
Our gratitude for alerting us to this new research goes to Vera Hassner Sharav with the Alliance for Human Research Protection (AHRP) (www.researchprotection.org)
Dr. Arif Khan presented his research at a recent meeting sponsored by the National Institute of Mental Health. This was a meeting of the New Clinical Drug Evaluation Unit. The essence of the research was an analysis of the data on the suicide rate for patients who participated in the clinical trials for these new drugs - over 71,604 people. Now these are the clinical trials where these drugs were tested on the public to see if they were "safe and effective." This clinical data is then presented to the FDA for approval for marketing of these new compounds.
In his presentation Dr. Khan made note of what we learned long ago when this information was revealed through court documents in SSRI wrongful death cases - that is, that "actively suicidal" patients are excluded from the clinical trials on the SSRI antidepressants. What he found shocking about this is that despite the actively suicidal being excluded from these clinical trials the suicide rate among those taking these medications ABSOLUTELY SKYROCKETED from 11 out of 100,000 to 718 out of 100,000 !!!
So, what I want to know is who is it that flunked their math courses - the FDA or the drug company researchers?!! Obviously it was both!
This data is not only shocking, it is horrifying! I urge you to look beyond the numbers to see the individuals behind those numbers who lost their lives as a result. This is not a mere "error" made by the FDA or the drug companies, it is a modern day holocaust when you begin to calculate the number of dead.
Please excuse me while I REALLY scream . . . I'm not going to say I TOLD YOU SO!!!!! BUT, FOR 13 VERY LONG YEARS I HAVE BEEN TELLING THE WORLD THAT THESE DRUGS THAT INCREASE SEROTONIN CAUSE SUICIDE, RATHER THAN CURING IT!
What frightens me more than anything at this point of realization is millions of patients going into withdrawal from these drugs. The rapid or abrupt withdrawal from these antidepressants can produce suicide, mania, seizures, psychotic breaks, etc. at an even greater rate than while on the drugs. Extreme caution MUST be taken.
Here are the suicide rates. Keep in mind as you read through these that the rate of 11 out of 100,000 persons per year is the suicide rate for the population at large.
*752 per 100,000 for those treated with atypical antipsychotics--risperidone (Risperdal), olanzapine (Zyprexa), and quetiapine (Seroquel);
*718 per 100, 000 for those treated with the SSRIs - Selective Serotonin Reuptake Inhibitors (Prozac, Zoloft, Paxil, Luvox, Celexa)
*425 per 100, 000 for those treated for "social anxiety disorder" with nefazodone (Serzone), mirtazapine (Remeron), and bupropion (Wellbutrin/Zyban);
*136 per 100,000 for those treated for panic disorder--with benzodiazepine alprazolam (Xanax);
*105 per 100, 000 persons for those treated for obesessive-compulsive disorder with anticonvulsant valproate (Depakote).
These figures clearly speak for themselves. The massive numbers of wrongful death suits will obviously follow. At least loved ones will know why they have lost those who meant so much to them via such tragic circumstances.
Keep in mind as you read through this data that the new antipsychotics listed here are basically a combination of the older antipsychotics and the SSRIs. They too have a STRONG effect upon serotonin levels. Also the most likely reason researchers saw an even higher rate of suicide in placebo with the antipsychotics is that these patients were likely being abruptly discontinued from their older antipsychotics for the clinical trials. This abrupt withdrawal causes suicide.
Dr. Ann Blake Tracy Executive Director International Coalition for Drug Awareness www.drugawareness.org
and the author of Prozac: Panacea or Pandora? - Our Serotonin Nightmare
800 280-0730 Office 801-282-5282
August 2002 . Volume 30 . Number 8
Analysis of large database Antisuicidal Effect Of Psychotropics Remains Uncertain 'We have to ask if medication is the only way' to approach the prevention of suicide.
By Carl Sherman Contributing Writer
BOCA RATON, FLA. - Psychotropic therapy did not appear to have a marked impact on suicide risk, examination of a large database indicated-in fact, no class of medication had much more or less effect than placebo, Dr. Arif Khan said at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.
Overall, attempted and completed suicides among patients with diverse psychiatric conditions are substantially more frequent than had been expected, the analysis suggested.
"Given that suicide is such a complex behavior ... we have to ask if medication is the only way to [approach] it," said Dr. Khan of Northwest Clinical Research Center, Bellevue, Wash.
The conventional response to suicidality in psychiatry is pharmacotherapy. The assumption that this will be beneficial "is never challenged much," Dr. Khan said, and raises ethical questions about clinical trials, such as whether patients assigned to placebo may be exposed to increased mortality risk. Some observers, on the other hand, have suggested that psychotropics may themselves increase the risk of suicide.
In fact, the only biologic treatments for which there are many data on this score are ECT and lithium, which have been shown to reduce suicidality. More limited data support a similar effect for clozapine.
Dr. Khan reported an analysis of clinical trial data for drugs approved by the Food and Drug Administration between 1985 and 2000. This included suicide and attempted suicide rates for more than 71,604 patients treated with the atypical antipsychotics risperidone, olanzapine, and quetiapine; all the selective serotonin reuptake inhibitors; nefazodone, mirtazapine, and bupropion; the benzodiazepine alprazolam; and the anticonvulsant valproate.
One striking finding was the elevated rate of completed suicides for patients during these trials. Compared with the rate of 11/100,000 persons per year for the population at large, the rates of completed suicide were 752/100,000 persons per year for those in antipsychotic trials; 718 in antidepressant trials; 425 in trials of medication for social anxiety disorder; 136 for panic disorder; and 105 for obsessive-compulsive disorder.
This was particularly surprising in light of the attempt, in most clinical trials, to exclude patients who are actively suicidal, Dr. Khan said.
Figures on attempted suicide found similarly increased risk. The figures implied that 5% of patients who enroll in antipsychotic trials will attempt suicide in the following year; 3.7% of those in antidepressant trials will make an attempt; and 1.2% of those in trials of medication for anxiety disorders will attempt suicide.
Suicide rates were higher, in the trials taken as a whole, for patients who were assigned to placebo than to the investigational drug (1,750/100,000 persons per year vs. 710/100,000 persons per year). But because participants were exposed to placebo for far less time than to the drugs (a mean of 33 days vs. 148 days), this could not be assumed to indicate an antisuicidal effect of medication, he said.
In the case of trials for depression and anxiety disorders, suicide rates were in fact higher among those who received the investigational drug than placebo, Dr. Khan said.
The high rates of suicide among patients studied might suggest an "iceberg effect" in the general population. The numbers that come to light under the close scrutiny of the clinical trial situation indicate the extent to which attempted and completed suicides are concealed or mislabeled in the community, Dr. Khan speculated.
Highlights of Six Specific DSM-V Research Agenda
1. Basic Nomenclature Issues of DSM-V The most diffuse of the research agendas, this section consists of six independent subsections on issues of nomenclature:
How to define "mental disorder." DSM has never contained a detailed definition that is useful as a criterion for deciding what is, or is not, a mental disorder.
A useful definition should be developed.
Validity. DSM-V should possibly include a rating of the quality of information and quantity of information available to support different diagnostic systems.
Dimensionality vs. categories. Like the classification systems of many other branches of medicine, the DSM-IV system is categorical. A dimensional system would better represent variations in psychiatric symptomology, although it is premature to assume that DSM-V would be largely dimensional. However, research could provide valuable information about the usefulness of a dimensional system.
Reducing gaps between DSM-V and ICD-11. APA's goal has always been to link DSM with the World Health Organization's International Statistical Classification of Diseases and Related Health Problems. However, differences still interfere with the compatibility of the two systems. Reconciliation is recommended; in the future, the decision may be made to create a single, unified, worldwide system for diagnosing mental disorders.
Cross-cultural use of DSM-V. Diverse populations have diverse norms of functioning. To foster cross-cultural applicability of DSM constructs, norms, and guidelines, research should identify cultural variants in symptom definition and manifestation, and anthropologic approaches to different cultural models of mental illness.
Use of DSM-V in nonpsychiatric settings. Primary care providers now also use the manual that was developed for use by psychiatrists. The study group identified a need to define diagnostic criteria in ways that can be applied outside the traditional psychiatric interview. Research is needed to develop tools for this, including lab tests and diagnosis, and psychological testing and diagnosis using standardized, computer-scored symptom-rating scales.
2. Neuroscience Research Agenda to Guide Development of a Pathophysiologically Based Classification System The DSM classification system should evolve from symptomatic to etiologic, perhaps eventually becoming a multiaxial diagnostic system based on genotype, neurobiologic indicators, behavioral phenotype, environmental modifiers, and therapeutics. While this will probably not be reflected in DSM-V, neuroscience research over the next 10-20 years will have a profound impact on the existing diagnostic system.
3. Advances in Developmental Science This agenda focuses on the deficiencies of the DSM-IV in relation to diagnosing children. Because the individual is a product of nested environments, from childhood to adulthood research should focus on discovering the links between childhood and adult disorders, and include epidemiologic, neuroscience, and genetic studies of children. Early childhood diagnosis at preschool age should also be the focus of research.
4. Personality Disorders and Relational Disorders This agenda focuses on what many clinicians believe are the most unsatisfactory sections of the DSM-IV. It suggests creating a new dimensional model of diagnosing personality disorders instead of the current categorical classification system, which many feel fails to address the real-life complexity of these disorders.
Furthermore, the agenda suggests consideration of possibly introducing relational disorders with diagnostic criteria.
5. Mental Disorders and Disability This agenda recommends separating the constructs of psychiatric symptoms and functional impairment in order to enable research into the factors that explain the varying degrees of disability that are observed across patients, given the same level of symptom severity.
Removing the impairment criteria from psychiatric diagnosing also will encourage early intervention for those at risk of future morbidity.
6. Culture and Psychiatric Diagnosis DSM-IV criteria are meant to apply to all patients regardless of age, sex, or culture. However, different cultural backgrounds are tied to different expression of symptoms, and a generic set of criteria does not do justice to cultural diversity.
Research requires a truly integrative approach that investigates the expression of disorders, treatment response, and diagnostic criteria across the full population spectrum.
Copyright © 2002 by International Medical News Group. Click for restrictions. Clinical Psychiatry News Online
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