[SSRI-Research] Antidepressant drug induced Suicides: Evidence of Iceberg effect Revealed

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SSRI-Research

ahrp.org

Sat, 19 Jun 2004 21:13:31 -0000

[sSRI-Research] Antidepressant drug induced Suicides: Evidence of

" Iceberg effect " Revealed

 

Canada West reports today: " At least five teenagers in Canada have

died, four of suicide, while being treated with the most widely

prescribed antidepressants in Canada and at least 100 other children

as young as 18 months old have experienced serious suspected adverse

reactions to the pills. "

 

See: http://www.canada.com/montreal/montrealgazette/news/story.html?

id=a9705835-8241-4dd0-9559-a7e7b6bf2c3f

 

But news reports linking antidepressants to teenage suicides provide

a mere hint of a major, preventable health crisis. The crisis is a

consequence of unbridled greed, an impotent drug regulatory system,

and a medical community that " just can't say no " to industry's

enticements.

 

An analysis of FDA's unpublished clinical trial data by Dr. Arif Khan

and colleagues found the suicide rate in SSRI antidepressant trials

to be 718/100,000 (when calculated per patient, per year). Dr. Khan

noted that this was particularly surprising in light of the attempt,

in most clinical trials, to exclude patients who are actively

suicidal.

 

He told a meeting of the New Clinical Drug Evaluation Unit of the

National Institutes of Health in August 2002: " In the case of trials

for depression and anxiety disorders, suicide rates were in fact

higher among those who received the investigational drugs than the

placebo....We have to ask if medication is the only way' to approach

the prevention of suicide "

 

See:

Clinical Psychiatry News. August 2002, Vol.30. Number 8.

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

 

This data was in FDA's possession. Therefore, FDA officials knew

about the high suicide rates during controlled clinical trials--yet,

they approved these drugs and failed to warn physicians or the public

about the risk. In fact, FDA officials intervened in court making

specious arguments against suicide warnings to protect drug companies.

See: Motus v Pfizer. US Court of Appeals, 9th Dist. September 2002.

Amicus Curiae brief in support of Pfizer, Inc. submitted by the FDA,

whose Chief Counsel claimed " any warning by Pfizer that suggested

causation would have subjected the company to federal regulatory

enforcement action. "

 

Dr. Khan speculated that " the high rates of suicide among patients

who tested the drugs 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. "

 

See: http://www.ahrp.org/infomail/0902/06.html

 

It is now possible to demonstrate the scope of that " iceberg effect "

scientifically.

 

Our colleague, Graham Aldred, a systems engineer in the UK, has

designed a new computer model called IMR (Investigative Medication

Routine) to calculate antidepressant drug-induced suicides using hard

data and real numbers.

 

Mr. Aldred has applied his IMR computer program to US SSRI sales

numbers--broken down by specific drug. The source for drug sales data

is IMS, the company that systematically tracks prescription sales

data for the pharmaceutical industry. (The FDA and NIH rely on IMS

for prescription data). By applying the IMR program to the IMS annual

sales figures for each drug, Mr. Aldred was able to calculate the

number of patients who have taken an SSRI in the US annually.

 

To arrive at the suicide rate among those taking an SSRI--adults and

children--Mr. Aldred did not use the high suicide rate of 718 per

100,000 that Dr. Khan's analysis found. Instead, he based his suicide

calculations on very conservative suicide rates: 34/100,000 to

104/100,000.

 

Mr. Aldred's original analyses are posted on the AHRP website. The

first analysis using the IMR to calculate the suicides using US

prescription sales data focused on Paxil (paroxetine).

 

See: http://www.ahrp.org/risks/aldred0404.html#letter

 

The analysis posted today focuses on the prescription sales data for

Prozac, Zoloft, and Paxil, for the years 1988-2002. The results show

that the number of people taking an SSRI, and the number of suicides

by those taking an SSRI are staggering.

 

The IMR calculation results show that since 1988, when Prozac

(fluoxetine), the first SSRI antidepressant was introduced to the US

market: 67,593,612 Americans have taken an SSRI. Specifically:

27,037,820 have taken Prozac; 18,530,071 have taken Paxil-paroxetine;

and 22,025,721 have taken Zoloft-sertraline.

 

See: http://www.ahrp.org/risks/usSSRIuse0604.pdf

 

When calculated at a 34/100,000 suicide rate, the number of SSRI

users who committed suicide totals 21,900. When calculated at a rate

of 104/100,000, the total reaches 70,297 suicides by persons taking

an SSRI antidepressant: of these, 28,119 may have been caused by

Prozac; 19,271 may have been caused by Zoloft; and 22,907 may have

been caused by Paxil.

 

FDA officials should be made to answer the following questions:

 

1) What standards has the FDA used to measure the " benefit " for SSRI

drug users?

 

2) How many " units of benefit " equate to one, preventable, drug

induced suicide ?

 

3) How many drug induced suicides will officials at the FDA, the

NIMH, and the psychiatric / medical community tolerate before robust

regulatory intervention is provoked ?

 

More likely, it will be NYS Attorney General, Eliot Spitzer, who will

get to the root of the problem and stop the rampant prescription drug

abuse of children.

 

Mr. Aldred is currently in the process of calculating the $$ cost of

SSRI consumption.

 

 

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare