[drugawareness] Followup on Blockbuster Study on Suicide Risk & Antidepressants

[Guest guest]

atracyphd wrote:

 

My Groups | drugawareness Main Page

 

 

You were all recently sent a message from me entitled something like:

Blockbuster Study - which was on the subject of the suicide risk of

antidepressants.

 

I want to make it clear to you that Dr. Khan believes that I am misquoting him

so I am sending all of you the interchange we have had about this study.

 

I firmly believe it is important to have all sides of the issue discussed. Both

of our arguements are presented in the following interchange of e-mail.

 

Dr. Ann Blake Tracy, Executive Director,

International Coalition For Drug Awareness

www.drugawareness.org & author of Prozac: Panacea

or Pandora? - Our Serotonin Nightmare (800-280-0730)

 

Dear Dr. Khan,

 

I would be more than happy to post your analysis of this research. I would like

very much to read your analysis of this data. I will also be more than happy to

post a correction if you can correct this for me. However there are some serious

issues in this data that need to be addressed. This is why I wrote to you before

requesting the full data of this research in order to analyze it properly.

 

In paragraph 12 you mention that the suicide rate was higher on the

investigational drug than on the placebo. It did not say how much higher . . .

so how much higher was that Dr. Khan? This is why I wrote you to ask for the

entire paper so that I could look at all the data in order to form an opinion.

 

Were the patients who were given the newer antipsychotics taken off their older

antipsychotics to be given the newer or were they medication naive? This is such

an extremely important question that it should not be ignored either.

 

Even though I am not a statistician, I did get A's in math and when I subtract

11 from 718 I get 707 or a 65 times greater rate of suicide on the

investigational medication. Okay, I do realize that we are not comparing apples

to apples, so to speak, because the 718 suicides came from a " depressed "

population rather than a population that was not depressed.

 

Considering the way patients are recruited for these clinical trials for

depression with the flashy television ads, how do you quantify their depression?

[Personally I have witnessed those with a " down day " accepted for these trials.]

So were these people twice as depressed as you or I? Were they 10 times more

depressed? Were they even 20 times more depressed? I find it hard to believe

that they could even 10 times more depressed than you or I. But I will give you

the benefit of the doubt and say they were even 30 times more depressed than you

or I.

 

So . . . my question is: Why did they commit suicide at a rate 65 times greater

than you or I?! Should this not raise great concern, especially when research

has shown for over 50 years that if you impair serotonin metabolism - as do all

of the SSRI antidepressants - you produce impulsive murder and suicide?

 

Dr. Ann Blake Tracy, Executive Director,

International Coalition for Drug Awareness

www.drugawareness.org and author of Prozac:

Panacea or Pandora? - Our Serotonin Nightmare

 

 

 

In a message dated 9/9/2002 11:48:27 AM Pacific Daylight Time, mail

writes:

 

 

Dr. Stacy: I was sent this e-mail by Dr. Tiford. I was quite taken aback about

how you are falsifying the data I presented at NCDEU. I am requiring you to

take back your statements with apology immediately. You are making false

statements without looking at the data. This is reprehensible, professionally.

 

As I mentioned in my e-mail, I completely refute what you are saying, but was

not aware of the extent to which you are falisfying information.

 

Arif Khan

 

 

 

 

Tilford, J Mick [TilfordJohnM]

Monday, September 09, 2002 11:06 AM

Mail

suicide risk

 

 

Dear Dr. Khan:

 

FYI, I am a researcher at UAMS in Arkansas and came across this note. I have my

doubts so thought I would forward to you. We have a friend that was wrongly

convicted of murder following an intracerebral bleed and the defense used a

Prozac theory that failed. So my friends and I are big on this issue. I would

rather they focus on the effects of the bleed, but maybe there is something to

the Prozac withdrawal theory. However, if they are sending out bunk information,

I need to know about it. If you can debunk, I would love to hear from you.

 

JM Tilford, Ph.D.

Associate Professor

Health Economics

 

PS after reading your biography, I highly doubt the following.

 

--

Subj: [drugawareness] Blockbuster Study-68 Times Greater Suicide Risk With

Serotonergic Meds!

Sun, 8 Sep 2002 01:41:09 EDT

atracyphd

drugawareness

 

 

 

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 author of Prozac: Panacea

or Pandora? - Our Serotonin Nightmare (800-280-0730)

 

http://www2.eclinicalpsychiatrynews.com/scripts/om.dll/serve

 

 

August 2002 . Volume 30 . Number 8

 

News

 

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.

 

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.

 

 

 

2002 by International Medical News Group. Click for

restrictions. Clinical Psychiatry News Online