By Vera Hassner Sharav
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.

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:
Pills and kids may not mix
Anxiety over SSRIs. Five Canadian deaths could be among 100 adverse reactions involving children

http://www.canada.com/montreal/montrealgazette/news/story.html?id=a9705835-8
241-4dd0-9559-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An analysis of FDA's unpublished clinical trial data by Dr.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
e-mail: veracare@ahrp.org

******* *** *******

SHARAV ON THE THE SPITZER LAWSUIT:

New York State Attorney General, Eliot Spitzer, is being recognized as a
hero on both sides of the Atlantic. That's because, unlike FDA officials, he
knows how to use a "smoking gun" to affect change in corporate practices to
protect the public health!

An editorial in the Guardian (UK) notes that the significance of Sptizer's
lawsuit against GlaxoSmithKline, goes far beyond the modest fine it seeks.
This suit charges the company--and by extension the pharmaceutical
industry--with fraudulent marketing. Spitzer's suit is a quantum leap toward
redirecting the marketing practices for prescription drugs.

"..in choosing to charge the company with fraud, the New York suit may
change the way pharmaceutical companies market and sell their drugs."

Spitzer's probe may help restore the integrity of medicine by exposing the
physicians who collaborated in industry's fraudulent practices. The
integrity of medicine hinges on disengagement from the corrupting influence
of pharmaceutical $$ incentives.

See: "Smoking gun" internal 1998 Glaxo memo:
http://www.ahrp.org/risks/SSRI0204/GSKpaxil/pg1.html