Summary:

Paragraphs 3 & 4 read: "In this trial, Prozac (fluoxetine) was tested in 49 young women against a placebo given to 40 women."

"The study authors report: 'A 17-year-old patient assigned to fluoxetine {Prozac} made a suicide attempt during the study"--none on placebo. This confirms the accuracy of FDA's warning that antidepressants pose a 1 in 50  risk of suicidality for children and adolescents.'"


ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org/cms/

  FYI

A team of researchers from Columbia University and the University of
Toronto, headed by Dr. Timothy Walsh (New York) tested the effect of
antidepressants in the treatment of anorexia in a placebo controlled
randomized trial. Their findings overturn the legitimacy of prescribing
these drugs for eating disorders: the drugs don't work when compared to
placebo.

Indeed, the use of Prozac, a drug known to reduce food intake--which some
doctors have misprescribed it for weight loss--to treat someone who is
starving to death, defies logic and common sense.   However, as every
medical doctor knows, the purveyors of psychotropic drugs have never been
held to scientific standards.

In this trial, Prozac (fluoxetine) was tested in 49 young women against a
placebo given to 40 women.

The study authors report: "A 17-year-old patient assigned to fluoxetine made
a suicide attempt during the study"--none on placebo.
This cofirms the accuracy of FDA's warning that antidepressants pose a 1 in
50  risk of suicidality for children and adolescents.

Indeed in this study, the rate of actual ATTEMPTED SUICDE--reaquiring
hospitalization--is one in 49.

The authors conclude: "These data imply that therapeutic efforts would be
better devoted to psychological and behavioral interventions for which there
is some, albeit modest, evidence of efficacy."

See, Timothy Walsh, et al,  Fluoxetine After Weight Restoration in Anorexia
Nervosa A Randomized Controlled Trial, published in the Journal of the
American Medical Assocition, June 14, 2006-Vol 295, No. 22 2605-2612.

The New York Times report (below) quotes Dr. Walter Kaye of Pittsburgh
University--a major promoter of antidepressants for eating disorders--who
seems oblivious to the dagners of these drugs when he suggests that even if
the drugs have proven worthless as a treatment for anorexia, they should be
used because he "thinks" so. His reasoning defies the Hippocratic Oath:
"Above all, do no harm."  "For patients like these, who don't have access to
psychological treatments, who have a choice between medication or nothing at
all, I think the medication could help," Dr. Kaye said.

That's irresponsible, faith-based medicine--having more in common with
voodooo than evidence-based medicine.

Dr. Kaye's speculative flights of imagination--in the absence of scientific
evidence--were transcribed in a NewsWeek cover story:

"scientists are tracking important differences in the brain chemistry of
anorexics. Using brain scans, researchers at the University of Pittsburgh
led by professor of psychiatry Dr. Walter Kaye, discovered that the level of
serotonin activity in the brains of anorexics is abnormally high. These
pumped-up levels of hormone may be linked to feelings of anxiety and
obsessional thinking, classic traits of anorexia. Kaye hypothesizes that
anorexics use starvation as a mode of self-medication. How? Starvation
prevents tryptophane, an essential amino acid that produces serotonin, from
getting into the brain. By eating less, anorexics reduce the serotonin
activity in their brains, says Kaye, "creating a sense of calm," even as
they are about to die from malnutrition.

See: http://www.msnbc.msn.com/id/10219756/site/newsweek/page/2/

Bellow is an abstract of a recent scientific report published in the
Archives of Pharmaceutical Research, confirming consistent decades old
animal research findingts:
 SSRIs suppress appetite. These scinetists found  evidence suggesting that
antidepressants may actually induce anorexia!!

Arch Pharm Res. 2005 Jun;28(6):716-21.

Role of neuropeptide Y and proopiomelanocortin in fluoxetine-induced
anorexia.

Myung CS , Kim BT, Choi SH , Song GY , Lee SY  Jahng JW

Laboratory in Pharmacology, Chungnam National University College of
Pharmacy, Daejeon 305-764, Korea. cm8r@cnu.ac.kr

Fluoxetine is an anorexic agent known to reduce food intake and weight gain.
However, the molecular mechanism by which fluoxetine induces anorexia has
not been well-established. We examined mRNA expression levels of
neuropeptide Y (NPY) and proopiomelanocortin (POMC) in the brain regions of
rats using RT-PCR and in situ hybridization techniques after 2 weeks of
administering fluoxetine daily.

Fluoxetine persistently suppressed food intake and weight gain during the
experimental period. The pair-fed group confirmed that the reduction in body
weight in the fluoxetine treated rats resulted primarily from decreased food
intake. RT-PCR analyses showed that mRNA expression levels of both NPY and
POMC were markedly reduced by fluoxetine treatment in all parts of the brain
examined, including the hypothalamus. POMC mRNA in situ signals were
significantly decreased, NPY levels tended to increase in the arcuate
nucleus (ARC) of fluoxetine treated rats (compared to the vehicle controls).
In the pair-fed group, NPY mRNA levels did not change, but the POMC levels
decreased (compared with the vehicle controls).

These results reveal that the chronic administration of fluoxetine decreases
expression levels in both NPY and POMC in the brain, and suggests that
fluoxetine-induced anorexia may not be mediated by changes in the ARC
expression of either NPY or POMC.

It is possible that a fluoxetine raised level of 5-HT play an inhibitory
role in the orectic action caused by a reduced expression of ARC POMC
(alpha-MSH).


Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org < mailto:veracare@ahrp.org>



http://www.nytimes.com/2006/06/14/health/14prozac.html?_r=1&oref=slogin

Study Sees No Gain in Using Antidepressant to Treat Anorexia
By BENEDICT CAREY
Published: June 14, 2006

One of the most widely used treatments for the eating disorder anorexia
nervosa, the antidepressant Prozac, works no better than dummy pills in
preventing recurrence in young women who have recovered from it, researchers
are reporting today.

Fluoxetine After Weight Restoration in Anorexia Nervosa (JAMA) The study,
the most rigorous to date to test the use of medication for anorexia, should
alter treatment for an illness that is often devastatingly chronic and that
has a higher mortality than any other psychiatric disorder, experts said.
Fewer than a third of the study's participants, who also received regular
psychotherapy, remained healthy for a year or more, whether they received
drug treatment or not, the study found.

An estimated 1 percent of Americans, or about three million people, mostly
young women, will at some point suffer from the self-starvation and
obsessive anxiety about weight that characterize anorexia, and surveys find
that about two-thirds of them receive treatment with Prozac or similar
antidepressants, which are considered generally interchangeable.

Research suggests that the drugs can be useful in helping people recover
from bulimia  nervosa, an eating disorder involving bingeing and purging
that causes less dramatic weight loss than anorexia. But the new findings
put to rest hopes from earlier work that these benefits might carry over to
anorexia, experts said.

"Physicians who are trying to help people with anorexia remain symptom-free
should not count on getting substantial benefits from antidepressants," said
Dr. B. Timothy Walsh, the lead author of the study, who is director of
eating disorders research at the New York State Psychiatric Institute at the
Columbia University Medical Center

"Doctors should be looking at other things, like good psychological
treatments," Dr. Walsh said.

In the study, appearing in The Journal of the American Medical Association,
researchers from Columbia and the University of Toronto monitored 93 women,
ages 16 to 45, who, after receiving intensive psychotherapy, gained enough
weight to fall into the normal range. Half the group then received daily
doses of Prozac, and the other half took dummy pills. All of them continued
in weekly psychotherapy, where they practiced techniques to examine and
diffuse irrational assumptions about weight and body image.

After a year, 26 percent of those on Prozac and 31 percent of those taking
placebo pills remained in a healthy weight range, the study found. The
differences between the two groups, in weight and on measures of beliefs
about food and weight gain, were not large enough to be significant.

"This study will change practice, beginning with the community of doctors
who specialize in eating disorders and spreading more broadly" to other
doctors, said Dr. Scott Crow, a psychiatrist at the University of Minnesota
, who wrote an editorial accompanying the study.

Dr. Walter Kaye, a professor of psychiatry at the University of Pittsburgh
said the new findings should not rule out the use of antidepressant
treatment altogether. In 2001, Dr. Kaye published a small study suggesting
that Prozac did help some young women who had recovered from anorexia keep
on weight. They were women who did not binge - they ate very little - and
did not receive psychotherapy.

"For patients like these, who don't have access to psychological treatments,
who have a choice between medication or nothing at all, I think the
medication could help," Dr. Kaye said.

All agree that the new findings emphasize the importance of thinking
creatively about treatment. The best psychotherapy available, said Dr. Crow,
helps only about a third of anorexia patients recover. Another third learn
to moderate and live with their aversions to food, while the rest develop a
chronic disorder, putting them at high risk for suicide   or death from
starvation.

Researchers are experimenting with several new therapeutic techniques. One
is a type of family therapy for adolescents, in which parents take charge of
all meals. The parents decide how much their daughter or son should eat -
based on specific guidelines - and reward good behavior, if appropriate.
Several studies suggest that this approach can lead to sustained recovery in
some teenagers. Some evidence suggests that this kind of close monitoring by
a therapist can also help adults with the disorder.

Psychiatrists have experimented, so far in vain, with a wide variety of
drugs for treatment, including antipsychotic medications, so-called
mood-stabilizing drugs like lithium and agents similar to the active
ingredients in marijuana.

"It's disappointing, really," Dr. Walsh said. "We would like to do better.
We need to do better."


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