Antidepressant drug induced Suicides:
Evidence of "Iceberg effect"
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting openness and full disclosure
http://www.ahrp.org
FYI
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An analysis of FDA's unpublished clinical trial data by Dr.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@ahrp.org
Last Updated on
06/14/04
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