Cymbalta SSRI Drug Study Induces Suicide
Suffering through unspeakable grief are the parents of 19 year old Traci Johnson, a normally healthy, 19-year-old with no history of depression. She needed money for college, and signed on as a participant for $150 a day in a Lilly drug trial for “urinary stress incontinence” which involved the SSRI drug, Cymbalta. Four weeks after starting on the drug, she hung herself with a scarf in the shower room. David Shaffer, an Eli Lilly spokesman in Indianapolis, admitted that five test subjects including Tracei committed suicide while in the drug study (none were depressed before entering the study. Remember, the study was testing a urinary tract problem). (1)(2)(3)(4)(5)
FDA Black Box Warning
This story is not an isolated event. There are 1,400 similar stories of SSRI induced suicide and violence including 18 school shootings, 41 road rage tragedies, and 110 murder-suicides. (6) In response to this, the FDA issued an SSRI-Suicide advisory on March 22, 2004, and a “black box” suicide warning label on all SSRI drugs January 2005. In 2002, 11 million prescriptions for SSRI drugs were given to children, 2.7 million of them to children under 12. (7)(8)(9)(10)
Common Findings in Patients on SSRI's
SSRI drug use is so prevalent in the population that many patients come through my office with the obvious signs of exhaustion, insomnia and agitation. They may have purple rings under the eyes, and they usually have hyper-active reflexes. The involuntary facial movements, tics, and mouth and tongue movements are common and can also be observed in the general population at large. For example, when observing nationally televised political speeches, the figures in the background may demonstrate involuntary facial movements indicating long term SSRI drug usage. (11) These movements are also called “Tardive Dyskinesia” and includes rhythmic involuntary movements of the tongue, face, mouth, or jaw (e.g. frequent poking out of the tongue, chewing, puckering, or blowing out of the cheeks).
Adverse Side Effects
Tardive dyskinesia is a dreaded complication of anti-psychotic medications like prolixin and haldol, in the past associated with institutionalized patients. It is actually an iatrogenic form of Parkinson’s disease with a tremor upon initiation of voluntary motion and the classic pill rolling hand tremor. In its early stages, the SSRI induced dyskinesia effect can be subtle. For example, one day my tennis partner exhibited signs of SSRI drug use. I noticed he could easily hit a winning angled shot into the corner, but completely lost his coordination from the intentional effort of the serve which went wild. He later disclosed he had been taking an SSRI drug for many years. Anyone concerned about maintaining fine motor coordination should be aware of this side effect. (11)
Listening to Prozac
In the early 90’s, Peter Kramer’s book, Listening to Prozac, suggested that Prozac and other SSRI drugs were safe, non-habit forming and suitable as treatment for mild social phobias. (12) Kramer also speculated that this SSRI drug invites a future possibility of “cosmetic psychopharmacology", in which the patient becomes more confident, articulate and less bashful and shy while on the drug. Prozac would produce a “more socially confident“ personality. In those days, my doctor colleagues would laud the SSRI drugs they were taking, and those who couldn’t take them made excuses. The surgeons couldn’t take the SSRI drugs because it caused a tremor which interfered with eye hand coordination and impaired their ability to operate.
Hidden Dangers of SSRIs
Of course, we know now the hidden dangers of the SSRI antidepressants that experts like David Healy (Let them Eat Prozac), Joseph Glenmullen (Prozac Backlash) and Peter R. Breggin (Talking Back to Prozac) have been writing about for years. (13)(14)(15)(16) Not only do the SSRI drugs cause akathesia, a form of agitation which drives people to commit suicide, they also cause sexual dysfunction (impotence), tremor, involuntary body and facial movements, tardive dyskinesia, and hyperactive reflexes indicating a hyperactive nervous system. The SSRI induced loss of sexual function may be irreversible even after discontinuation of the drug.(17)(18)(19)(20)
Akasthesia, Suicide and Self Harm from SSRI Drugs
As pointed out by David Healy, the SSRI drugs (selective serotonin reuptake inhibitors) are by no means selective in their actions on brain neurotransmitter systems. Imagine a pinball let loose in the pinball machine. Most of the time the pinball hits the correct bumpers and lights up the scoreboard. However, in a small percentage of patients the pinball bounces around affecting the wrong neurotransmitter systems in the brain, causing the machine to go “tilt”. These are the “akasthesia”, agitation cases estimated by the FDA to affect 1 in 50 patients, some of these inflicting self harm or commiting suicide. (7) The drug companies who finance the research have simply avoided the question of why this happens. For example, what are the preliminary lab tests to identify the subpopulation at risk for these adverse effects? We don’t know. Currently the only test is a trial of the SSRI medication to find out. As pointed out by Healy during FDA testimony, we track postal parcels 100 times better than we track adverse side effects from SSRI drugs.
University of Illinois Medical School
I started medical school at the University of Illinois in Chicago in 1972. Robert Mendelsohn (author of Confessions of a Medical Heretic) was my adviser and I spent a few evenings at his dinner table learning things about the institution of medicine not safely repeated to anyone if I wished to continue medical school (1)(2).
After a full year listening to basic science lectures and taking exams, our class was released into the hospital wards to start clerkships. This involved making rounds with the intern and resident team examining patients and doing the “scut work” which maintained the University teaching hospital (3). Doing rounds was a daily ritual, and we methodically worked our way up and down the long corridors which had the distinctive smell of alcohol and pseudomonas.
My first rotation was internal medicine, and we saw the usual litany of diseases: diabetes, rheumatoid arthritis, GI bleeding, congestive heart failure, cancer, and various bacterial and viral infections. After examining each patient, we convened in the hallway wearing our long white coats and stethoscopes as in a football huddle to discuss the diagnosis and treatment. Actually, the discussion was between the intern and resident, while the rest of us listened in. The two of them routinely had a running debate punctuated by brief forays into the rooms to examine patients. Both of them were armed with a pocket notebook inscribed with references to the medical literature which was brandished to support their decisions regarding testing or treatment. On a good day, I endeared myself to the intern by starting a difficult I.V., or by making a diagnostic coup like homonymous hemianopsia or acute intermittent porphyria.
Fraud and Misconduct in SSRI Research
In those days, the medical literature was rock solid truth and trustworthy beyond question. It was inconceivable to us that any doctor would ever falsify or distort the results of a medical study or research. After all, people’s lives were hanging in the balance. This gradually changed over time. I am not sure when awareness of problems with the medical literature emerged and it became sadly obvious that much of medical science is up for sale. After this revelation, I became skeptical and I now tend to believe the data more than the written conclusions of any medical study. A recent example of this fraudulent conduct in medical research is given in the BBC documentary on the SSRI drug Seroxat (Paxil) and pediatric prescriptions (4)(5).
Minimal Benefit in Children
We have previously discussed the adverse risks of SSRI drugs including agitation, suicidal or violent behavior, movement disorders, and chemical dependency (6) in adults. We might imagine their "side effects" in children are no less, but what about their efficacy? Surely they must be magic pills against a debilitating "illness" to risk such terrible consequences. However, Jon Jureidini in a comprehensive review of the available data found only minimal benefit from the SSRI drugs in children. He writes, ” The magnitude of benefit is unlikely to be sufficient to justify risking those harms, so confidently recommending these drugs as a treatment option, let alone as first line treatment, would be inappropriate.” (7)
A Dirty Little Secret
According to Irving Kirsch in Prevention & Treatment , “there is now unanimous agreement that the mean difference between response to antidepressant drugs and response to inert placebo is very small. It is so small that, despite sample sizes involving hundreds of participants, 57% of the trials funded by the pharmaceutical industry failed to show a significant difference between drug and placebo. Most of these negative data were not published and were accessible only by gaining access to US Food and Drug Administration (FDA) documents. The small difference between the drug response and the placebo response has been a "dirty little secret". It was not known to the general public, depressed patients, or even their physicians”.(8)
Manipulating the Data
Various methods were used to manipulate the results of SSRI drug studies to insure a favorable outcome:
1) Responders to the placebo are eliminated at the beginning of the study. (Placebo washout)
2) Benzodiazepine sedatives were given to mask the SSRI induced agitation.
3) Unfavorable drug studies are buried in the file cabinet and not disclosed to the public.
4) Miscoding suicidal events as "emotional lability", and homicidal events as "aggression" to hide suicidal events from regulators.
5) False attribution of suicide to the placebo arm.
6) Hiring ghost writers to make the medical articles more favorable.
7) Cash settlements for SSRI drug litigants which seals records and withholds unfavorable drug studies from the public.
Using these and other gimmicks, the drug industry managed to gain FDA approval for the SSRI class of drugs. Since the FDA approval is the foundation of our medical system, the first step in restoring integrity is to halt the “waiver system” which gives doctors immunity from prosecution for conflicts of interest. The system allows doctors to deliberate on FDA advisory committees while receiving money from the drug industry, a conflict of interest that is also a federal crime (9)(10).
Direct to Consumer Advertising
The harm caused by consumer drug advertising was discussed in a previous report (11). Direct to consumer advertising of SSRI drugs presents the message that depression is a disease caused by a chemical imbalance in the brain, namely a deficiency of serotonin, which is cured by the SSRI drug (12). The precursor to the neurotransmitter serotonin is tryptophan (5-HTP), a naturally occurring amino acid. Unfortunately, the serotonin deficiency concept as presented by the DTC advertising is poorly supported by medical science (13). In addition, it is well known that brain serotonin can be increased safely with ingestion of a food supplement, 5HTP, available at the health food store. Why risk the adverse side effects of SSRI drugs when a safer alternative is available? (14)
The True Utility of SSRI Drugs
The unfortunate soul who loses his job, gets divorced or experiences the grief of a death in the family now has a “disease” caused by a chemical imbalance which requires him to be prescribed an SSRI drug. This is not a description of a disease state. This is a description of a life event which makes anyone depressed, and the treatment is the support of friends and family through a difficult time. Perhaps the depressed individual bears inner turmoil of unresolved conflicts with work or family, and the SSRI drug “numbs” the individual to this unbearable inner conflict, allowing continuation of the job or unhappy home. Perhaps this is the true utility of SSRI drugs in our society.
Drugging of Our Children
We have known about SSRI drug induced suicide since Teicher’s landmark article in 1990 (15). Where is the overpowering sense of public outrage that should have banned these drugs in children years ago? The drug industry, the FDA and the medical profession continue the widespread drugging of our children with addictive toxic placebos in an uncanny similarity to the classic Lucas film THX 1138, a science fictional remake of Orwell’s 1984 which paints a totalitarian world of enslaved citizens controlled by drugs (16)(17).
Sacrifice of Isaac
Child sacrifice is an important theme of the three major, monotheistic religions (18). Abraham’s intended sacrifice of Isaac took place at the “Dome of the Rock” on the temple mount, near the “Wailing Wall” in the old city of Jerusalem. Isaac’s life was spared at the last minute by an angel who ordered Abraham to sacrifice a ram instead. We know today's Abrahams and Issacs well enough, but the horizon seems frighteningly devoid of any signs of angels.
Jeffrey Dach MD
4700 Sheridan Suite T
Hollywood Fl 33021
(1) http://www.antidepressantsfacts.com/Traci-Johnson-19-duloxetine2.htmPosted on Tue, Feb. 10, 2004 Woman testing depression drug kills herself
BY GLORIA CAMPISI Knight Ridder Newspapers
Suicide brings changes to Lilly drug trials By J.K. Wall and John Tuohy
February 11, 2004
(3) http://www.antidepressantsfacts.com/Traci-Johnson-19-duloxetine4.htmWed, Feb. 11, 2004 Bucks woman found dead in Ind. laboratory Traci R. Johnson was found at clinic where she was part of testing for a new drug.
By Walter F. Naedele Inquirer Staff Writer
Thu, Feb. 12, 2004 Drug test altered in wake of suicide By Walter F. Naedele Inquirer Staff Writer
Student, 19, in Trial of New Antidepressant Commits Suicide By GARDINER HARRIS Published: February 12, 2004
SSRI Stories Antidepressant Nightmares WARNING! Withdrawal can often be more dangerous than continuing on a medication. It is important to withdraw extremely slowly from these drugs, usually over a period of a year or more, under the supervision of a qualified specialist.
FDA - Antidepressant Use in Children, Adolescents, and Adults, The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).
Antidepressants and placebos: Secrets, revelations, and unanswered questions. July 15, 2002. Responds to numerous comments on the authors' original article (see record 2002-14079-003) on drug and placebo responses in studies on antidepressants. Unlike some of the responses to a previous meta-analysis of antidepressant drug effects (I. Kirsch and G. Sapirstein, 1998),
there is now unanimous agreement among commentators that the mean difference between response to antidepressant drugs and response to inert placebo is very small. It is so small that, despite sample sizes involving hundreds of participants, 57% of the trials funded by the pharmaceutical industry failed to show a significant difference between drug and placebo. Most of these negative data were not published and were accessible only by gaining access to US Food and Drug Administration (FDA) documents. The small difference between the drug response and the placebo response has been a "dirty little secret," known to researchers who conduct clinical trials, FDA reviewers, and a small group of critics who analyzed the published data and reached conclusions similar to that of the authors. It was not known to the general public, depressed patients, or even their physicians. The authors are pleased that their effort facilitates dissemination of this information. Kirsch, Irving; Scoboria, Alan; Moore, Thomas J. , Prevention & Treatment. 2002 Jul Vol 5(1)
Published on Monday, September 25, 2000 in USA Today, FDA Advisers Tied To Industry,by Dennis Cauchon, More than half of the experts hired to advise the government on the safety and effectiveness of medicine have financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions, a USA TODAY study found.
Testimony of David J. Graham, MD, MPH, November 18, 2004, Mr. Chairman and members of the Committee...The big picture. The problem you are confronting today is immense in scope. Vioxx is a terrible tragedy and a profound regulatory failure. I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless. It is important that this Committee and the American people understand that what has happened with Vioxx is really a symptom of something far more dangerous to the safety of the American people. Simply put, FDA and its Center for Drug Evaluation and Research are broken.
Jeffrey Dach on Lipitor and "The Dracula of Modern Technology" Jan 3 2007
Zoloft web site, "Scientists believe that it could be linked with an imbalance of a chemical in the brain called serotonin. If this imbalance happens, it can affect the way people feel. "
Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature Jeffrey R. Lacasse, Jonathan Leo*
Use of Neurotransmitter Precursors for Treatment of Depressionby Stephen Meyers, MS, Thorne Research
Emergence of intense suicidal preoccupation during fluoxetine treatment.
Teicher MH, Glod C, Cole JO. Department of Psychiatry, Harvard Medical School, MA.
Six depressed patients free of recent serious suicidal ideation developed intense, violent suicidal preoccupation after 2-7 weeks of fluoxetine treatment. This state persisted for as little as 3 days to as long as 3 months after discontinuation of fluoxetine. None of these patients had ever experienced a similar state during treatment with any other psychotropic drug.
THX-1138 Population controlled by a government controlled sedating drug program
March 16-17, 1995 - Symposium on The Sacrifice of Isaac in the Three Monotheistic Religions
Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration
Irving Kirsch, Brett J. Deacon, Tania B. Huedo-Medina, Alan Scoboria, Thomas J. Moore5, Blair T. Johnson
Irving Kirsch, summarising the paper, says: “Although patients get better when they take antidepressants, they also get better when they take a placebo, and the difference in improvement is not very great. This means that depressed people can improve without chemical treatments.”
What Do These Findings Mean? These findings suggest that, compared with placebo, the new-generation antidepressants do not produce clinically significant improvements in depression in patients who initially have moderate or even very severe depression, but show significant effects only in the most severely depressed patients. The findings also show that the effect for these patients seems to be due to decreased responsiveness to placebo, rather than increased responsiveness to medication. Given these results, the researchers conclude that there is little reason to prescribe new-generation antidepressant medications to any but the most severely depressed patients unless alternative treatments have been ineffective. In addition, the finding that extremely depressed patients are less responsive to placebo than less severely depressed patients but have similar responses to antidepressants is a potentially important insight into how patients with depression respond to antidepressants and placebos that should be investigated further.
BMJ 2008;336:516-517 (8 March) Editorials, Efficacy of antidepressants Is not an absolute measure, and it depends on how clinical significance is defined
In February 2008, Kirsch and colleagues reported a meta-analysis of the efficacy of antidepressants using data from clinical trials submitted to the Food and Drug Administration. They provocatively concluded, "there seems little evidence to support the prescription of antidepressant medication to any but the most severely depressed patients."
SSRI's Wikipedia: Prozac, Lexepro, Zoloft, Effexor, Wellbutrin, Cymbalta, Paxil,
citalopram (Celexa, Cipramil, Emocal, Sepram, Seropram)
escitalopram oxalate (Lexapro, Cipralex, Esertia)
fluoxetine (Prozac, Fontex, Seromex, Seronil, Sarafem, Fluctin (EUR), Fluox (NZ))
fluvoxamine maleate (Luvox, Faverin)
paroxetine (Paxil, Seroxat, Aropax, Deroxat, Rexetin, Xetanor, Paroxat) sertraline (Zoloft, Lustral, Serlain)
dapoxetine (no known trade name)
Buy Placebos Here
Jeffrey Dach MD
4700 Sheridan Suite T
Hollywood Fl 33021
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his/her personal physicians and to only act upon the advice of his/her personal physician. Also note that concerning an answer which appears as an electronically posted question, I am NOT creating a physician -- patient relationship. Although identities will remain confidential as much as possible, as I can not control the media, I can not take responsibility for any breaches of confidentiality that may occur.
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(c) 2008 Jeffrey Dach MD All Rights Reserved
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