Antidepressant drug induced Suicides: Evidence of “Iceberg effect” Revealed
Thu, 10 Jun 2004
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An analysis of FDA’s unpublished clinical trial data by Dr.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.php
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.php#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