Subject: Tell the Truth About Antidepressants On Drug Labels & in Medical Journals
Date: Thu, 16 Sep 2004 17:47:15 -0400


To: Janet Woodcock MD; Robert Temple MD (temple@cder.fda.gov); Russell Katz
MD (katzr@cder.fda.gov); Thomas Laughren (LAUGHREN@CDER.FDA.GOV)


ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting openness and full
disclosure http://www.ahrp.org

FYI

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.


Contact: Vera Hassner Sharav
Tel: 212-595-8974
e-mail: veracare@ahrp.org