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Risks of Antidepressants: FDA Looks The Other Way

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Thu, 16 Sep 2004

An April, 2004 editorial in the New York Times noted: "What seems most astonishing is the skimpy evidence that these drugs work at all in most young patients."

What is astonishing is how the commercial / academic psychiatric drug establishment -- including the American Psychiatric Association, the National Institute of Mental Health, academic opinion leaders of psychiatry, including the "expert consensus panels" who make treatment determinations -- were able to fool the American public for over a decade with false claims about the safety and efficacy of the new "miracle" antidepressants -- the SSRIs.

The overall risk of suicide is characterized as "low" - two to three young people out of 100 patients are likely to have more suicidal thoughts compared to those given placebos.

But, as the Times Journal notes: "those numbers are flat out worrisome given the fact that the pediatric use of anti-depressants is soaring in the United States."

FDA's advisory panel recommendation is being criticized by both those with a stake in the drugs who regard any warning as "alarmist" and by those who want the drugs banned altogether: "The bottom line in the FDA panel's recommendations is akin to changing the Hippocratic oath - "First do no harm" - with one that says, "Give it a shot, but warn them first."

The Times Journal reports: Dr. Thomas Newman, a professor of pediatrics at the University of California, San Francisco, who was member of the FDA advisory panel, offered this summation: "We have very good evidence of harm and very little evidence of efficacy."

The truth about the antidepression hoax has been laid out in numerous books and articles, but the authors were pilloried by industry's stakeholders.

Until now, the public has been deceived by a highly organized, extremely well financed promotional apparatus. Fake science has been passed off as "evidence-based" treatment strategies; selective, partial data has been manipulated to show "positive" results; physicians and parents have been deceived -- and children were put in harm's way, exposed to potentially lethal drugs that have not demonstrated an effect greater than placebo.

In today's editorial (Sept. 16) the Times acknowledges: "The latest medical verdict on the use of antidepressant pills to treat teenagers and children is every bit as depressing as the original warnings raised months ago. There is remarkably little evidence that most of the pills are effective in treating depression in such young patients and increasing evidence that they can lead to suicidal thoughts and behavior ... Unfortunately, nothing in their arsenal is notably effective."

Based on the scientific evidence, it is clear that the safest and most effective treatment for childhood depression is placebo. Placebo carries no adverse side-effects, causes no stigma, and is free. To elicit a placebo effect, parents would do well to create a nurturing environment, provide lots of personal attention, listen attentively, and convey sense of optimism in the effectiveness of the treatment.

For parents who still want to expose their children to the drugs, an informed consent process must be established so that the risks are explained to parents BEFORE they are issued a prescription -- NOT an after the fact Medication Guide.

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Vera Hassner Sharav
Tel: 212-595-8974
e-mail: veracare@ahrp.org

Here is the New York Times article and other pertinent links:

THE NEW YORK TIMES EDITORIAL
(go to original)
September 16, 2004
Risks of Antidepressants

The latest medical verdict on the use of antidepressant pills to treat teenagers and children is every bit as depressing as the original warnings raised months ago. There is remarkably little evidence that most of the pills are effective in treating depression in such young patients and increasing evidence that they can lead to suicidal thoughts and behavior. An advisory panel to the Food and Drug Administration was quite right this week when it urged the strongest possible warnings for doctors and patients about the potential dangers.

The panel shied away from urging a complete ban on antidepressants for children and teenagers, and for good reason. Left untreated, depression can create a far greater suicide risk than the pills. Doctors desperately need weapons to combat major depression, even if those weapons carry some risk.

Unfortunately, nothing in their arsenal is notably effective. One large trial showed that talk therapy was no better than a placebo at alleviating depression in these young patients, and a vast majority of antidepressant pills have also failed when tested for this age group. Only Prozac has shown consistent effectiveness, and only Prozac has been specifically approved for use in young patients, although there is new evidence that it, too, can cause suicidal tendencies. The other antidepressants are prescribed by doctors in the belief, perhaps mistaken, that they are effective in young people.

The F.D.A.'s expert panel thought the pills too important to ban. A third of the panelists opposed even an extra-strong warning on information sheets for doctors lest it discourage treatment that could be lifesaving for some young patients.

The F.D.A. typically gives great weight to the views of its advisory committees, but it is not obliged to adopt them. What patients, parents and doctors most need is not just a warning, but the clearest possible guidance as to which of these drugs are safer and more effective than the others.

Copyright 2004 The New York Times Company
~~~~~~~~~~~~~~~~~

See related:

FDA Waffles Over Antidepressants Causing Suicides

Paxil, Zoloft, Xantax - Drug Induced Violence

FDA Covers Up Report - Mosholder: 'Antidepressants Double Suicides in Children'

Pfizer Sued in California: Covering up Zoloft Side Effects

Bush To Impose Psychiatric Drug Regime



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