FDA Orders Antidepressant Suicide Warnings Over Psychiatric Association Resistance
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The American Psychiatric Association (APA) has been strangely resistant to the idea of warning patients of an increased risk of suicides when taking antidepressant drugs or SSRIs. One would think that psychiatrists should be the first ones to call for such warnings, but perhaps they fear to "lose ground" to natural alternatives in the treatment of mental disorders, which they have been persecuting for decades, concentrating their treatment efforts nearly exclusively on the "chemical option".
Stefan Kruszewski, a Psychiatrist from Harrisburg, PA has raised the question in a letter to the British Medical Journal: APA at odds with FDA Advisory Panel
At the time that the FDA advisory panels were meeting and Dr. Robert Temple for the FDA and the AHRP-convened expert panel (including Dr. Healy) were recommending stronger warnings for antidepressants, The American Psychiatric Association issued its statement to “policymakers” in their News release. The APA specifically recommended: “The continuation of current FDA warnings with respect to SSRIs—warnings that are appropriate and consistent with the scientific data.”
Kruszewski further comments that "the APA is mired in special interests. Unfortunately, the welfare of individuals is not nearly as important to them as are the profits of the drug companies that support the organization. The APA and its sister organizations that include NTAC (National Technical Assistance Center for State Mental Health Planning) and SAMHSA proudly sponsor and endorse the President's New Freedom Commission on Mental Health ... all of them are sponsored heavily by Eli Lilly, Pfizer, Glaxo, Wyeth, Johnson and Johnson, Novartis, Abbott Labs ..."
Fortunately there was enough pressure from concerned citizens, but also from Congressional committees and New York Attorney General Spitzer to induce action by the FDA, even over heavy psychiatric resistance. See Vera Hassner Sharav's and Ann Blake Tracy's comments on the melee and the final outcome:
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ALLIANCE FOR HUMAN RESEARCH PROTECTION
www.ahrp.org
We have won the first battle in a struggle for full disclose of serious adverse drug effects and disclosure of failed clinical trials. Prescribing physicians and the public have an urgent need and a right to know. Not until Congressional committees and the Attorney General of New York entered the fray, and examined a body of concealed evidence, did FDA officials “see the light.”
From now on, parents will be informed that a causal relationship has been found between suicidal behavior and antidepressant drugs. They will, for the first time, be able to make an informed decision affecting their children’s health and lives.
See: http://www.fda.gov/bbs/topics/news/2004/NEW01124.html
For more than 15 years drug companies, the psychiatric establishment - including the American Psychiatric Association, the National Institute of Mental Health - and the FDA denied the link between antidepressants and increased suicide.
But the evidence from controlled clinical trials and post-marketing case reports is overwhelming: children and adolescents who were prescribed an antidepressant were twice as likely to become suicidal compared to those given a placebo. Furthermore, the drugs showed no clinically significant benefit beyond placebo.
News reports rarely disclosed that leading psychiatrists who are cited as “experts” have significant financial ties to the manufacturers of these drugs, and might therefore have a conflict of interest. Is it unreasonable to suspect that their steadfast defense of the drugs’ efficacy and safety might be even slightly influenced by their financial ties?
But journalists continue to be beguiled by speculative scientific hypotheticals which psychiatrists discuss as though they have been proven. Misinformation is transmitted to the public about unproven “chemical imbalances” in the brain of depressed people—when, in fact, NO EVIDENCE EXISTS demonstrating any chemical or structural brain abnormality in people diagnosed with a mental illness.
Indeed, no psychiatric diagnosis - for adults or children - has attained the scientific standard of a demonstrable medical disease. Psychiatry has only identified symptoms which may have any number of causes - some drug-induced, others due to a physiological disease. Thus, psychiatry’s authoritative (though flawed) diagnostic reference tool - the DSM IV - refers only to “disorders” not disease.
Although the focus, thus far, has centered on the suicide risk for children under 18, FDA’s warning for antidepressants applies to adults and children. Evidence exists demonstrating a suicide link to these drugs in adults as well.
A front page article in today’s Wall Street Journal refers to “decades of nueuroscience wisdom” then proceeds to transmit yet another round of speculative hypotheticals about children’s brains, promoted - without validation - by “expert” psychiatrists whose institutions are dependent on antidepressant drug company funding.
Neurogenesis
“A growing number of studies suggest that the antidepressants called SSRIs stimulate the birth of new neurons in the brain. Boosting this "neurogenesis" might have different effects on a developing brain than a mature one.
Adult brains, according to decades of neuroscience wisdom, weren't supposed to be able to make new neurons. But in a 2003 paper, molecular psychiatrist Ronald Duman of Yale and his colleagues showed that, in lab animals, antidepressants boost neurogenesis in parts of the brain.
The birth of new neurons takes time. Newborn neurons take weeks to travel to their target. Scientists now believe that this explains why SSRIs take weeks to affect depression.
The creation of new neurons in the brain had been assumed to be beneficial. In depressed adults, the hippocampus - the part of the brain responsible for learning, memory and emotion - is typically shrunken. By restoring it to full size, and presumably, full health, depression might be lifted. But in young people with depression, the hippocampus isn't shrunken. It may be that the influx of new neurons is somehow detrimental to adolescents. Some scientists wonder whether the new neurons could destabilize fragile brain circuits in kids suffering from mental illness.”
See: THE WALL STREET JOURNAL. Why Depression Looks Different In a Kid's Brain, By SHARON BEGLEY
New Studies May Help Explain Links Between Suicide And Antidepressant Use The Role of Impulse Control
October 15, 2004; Page A1
Contact: Vera Hassner Sharav
212-595-8974
[email protected]
ASSOCIATED PRESS
FDA Orders Strong Antidepressant Warnings
By DIEDTRA HENDERSON, AP Science Writer
WASHINGTON - All antidepressants must carry a "black box" warning, the government's strongest safety alert, linking the drugs to increased suicidal thoughts and behavior among children and teens taking them, the Food and Drug Administration said Friday.
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A comment by Ann Blake Tracy, Ph.D., Executive Director of the International Coalition For Drug Awareness - www.drugawareness.org - who has been campaigning for years against the use of these drugs and has warned of the suicide "side" effects.
FINALLY, after years of deadly drugs being available to children with no warning of the danger of increased fatalities due to suicide, the FDA issues a black box warning for all antidepressants on the market!
This is long overdue and many children have died or suffered serious damage as a result of this lack of warning. Perhaps NOW doctors will finally think before handing these drugs out like candy to children and teens.
The scientific evidence behind this has been out there for decades. All anyone ever had to do was read it. I explained that clearly in my latest testimony before the FDA on September 13, 2004. I will include that here.
I am Ann Blake Tracy, PhD, head of the International Coalition for Drug Awareness. I am the author of "Prozac: Panacea or Pandora." My house has been mortgaged to the hilt to pay for the last 15 years that I have devoted to nothing but research on SSRI antidepressants and to fund my trip here.
I have testified as an expert witness for twelve and a half years in court cases involving these drugs.
Research on serotonin has been clear from the very beginning, that the most damaging thing that could be done to the serotonergic system would be to impair one's ability to metabolize serotonin, yet that is exactly how SSRI antidepressants exert their effects. For decades research has shown that impairing serotonin metabolism will produce nightmares, hot flushes, migraines, pains around the heart, difficulty breathing, worsening of bronchial complaints, tension and anxiety which appear from out of nowhere, depression, suicide - especially very violent suicide and repeated attempts, hostility, violent crime, arson, substance abuse including cravings for alcohol and other drugs, psychosis, mania, organic brain disease [brain damage], autism, anorexia, reckless driving, Alzheimer's, impulsive behavior with no concern for punishment, and argumentative behavior.
How anyone ever thought it would be therapeutic to chemically induce these reactions is beyond me, yet these reactions are exactly what we witnessed in our society over the past decade and a half as a result of the widespread use of these drugs.
Can you remember two decades ago when depressed people used to slip away quietly to kill themselves rather than killing everyone around them and then themselves, as they do while taking an SSRI antidepressant?
A study out of the University of Southern California, in 1996, looked at a group of mutant mice that had been genetically engineered. In an experiment that had gone terribly wrong, they were the most violent creatures they had ever witnessed. They were born lacking the MAOA enzyme which metabolizes serotonin. The end result is the same as if they were taking an SSRI antidepressant which does inhibit the metabolism of serotonin.
This has been a national holocaust. It must end. These are extremely dangerous drugs that should have been banned as similar drugs were in the past.
As a society, we once thought LSD and PCP to be miracle medications. We have never seen drugs so similar to LSD and PCP as these SSRI antidepressants are. All of these drugs produce dreaming during periods of wakefulness. The higher serotonin levels overstimulate the brain stem leading to a lack of muscle paralysis. That was seen clearly in the case of comedian Phil Hartman and his wife in the terrible murder-suicide [whose wrongful death suit has been settled by the makers of Zoloft].
Thank you.
Ann Blake Tracy, Ph.D.,
Executive Director, International Coalition For Drug Awareness
Website: www.drugawareness.org
Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare & audio tape on safe withdrawal: "Help! I Can't Get Off My Antidepressant!"
Order Number: 800-280-0730
Office: 801-282-5282
Cell: 801-209-1800
