- 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
- 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
- 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
- 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,
- *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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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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