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Medical Forum / General / General / February 2008

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Depression Drugs Don't Work, Finds Data Review

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rpautrey2 - 26 Feb 2008 01:06 GMT
The Times
February 26, 2008

Depression drugs don't work, finds data review
David Rose

Millions of people taking commonly prescribed antidepressants such as
Prozac and Seroxat might as well be taking a placebo, according to the
first study to include unpublished evidence.

The new generation of antidepressant drugs work no better than a
placebo for the majority of patients with mild or even severe
depression, comprehensive research of clinical trials has found.

The researchers said that the drug was more effective than a placebo
in severely depressed patients but that this was because of a
decreased placebo effect.

The study, described as "fantastically important" by British experts,
comes as the Government publishes plans to help people to manage
depression without popping pills.

More than £291 million was spent on antidepressants in 2006, including
nearly £120 million on SSRIs. As many as one in five people suffers
depression at some point. With that in mind, ministers will today
publish plans to train 3,600 therapists to treat depression. Spending
on counselling and other psychological therapies will rise to at least
£30 million a year.

The study, by Irving Kirsch, from the Department of Psychology at the
University of Hull, is the first to examine both published and
unpublished evidence of the effectiveness of selective serotonin
reuptake inhibitors (SSRIs), which account for 16 million NHS
prescriptions a year. It suggests that the effectiveness of the drugs
may have been exaggerated in the past by drugs companies cherry-
picking the best results for publication.

The National Institute for Health and Clinical Excellence (NICE),
which is due to review its guidance on treating depression, said that
it would consider the study.

Mental health charities say that most GPs admit that they are still
overprescribing SSRIs, which are considered as effective as older
drugs but with fewer side-effects. SSRIs account for more than half of
all antidrepressant prescriptions, despite guidelines from NICE in
2004 that they should not be used as a first-stop remedy.

American and British experts led by Professor Kirsch examined the
clinical trials submitted to gain licences for four commonly used
SSRIs, including fluoxetine (better known as Prozac), venlafaxine
(Efexor) and paroxetine (Seroxat).

The study is published today in the journal PLoS (Public Library of
Science) Medicine. Analysing both the unpublished and published data
from the trials, the team found little evidence that the drugs were
much better than a placebo.

"Given these results there seems little reason to prescribe antide-
pressant medication to any but the most severely depressed patients,
unless alternative treatments have failed," Professor Kirsch said.
"The difference in improvement between patients taking placebos and
patients taking antidepressants is not very great. This means that
depressed people can improve without chemical treatments." He added
that the study "raises serious issues that need to be addressed
surrounding drug licensing and how drug trial data is reported".

The data for all 47 clinical trials for the drugs were released by the
US Food and Drug Administration under freedom of information rules.
They included unpublished trials that were not made available to NICE
when it recommended the drugs for use on the NHS. "Had NICE seen all
the relevant unpublished studies, it might have come to a different
conclusion," Professor Kirsch said.

Tim Kendall, a deputy director of the Royal College of Psychiatrists
Research Unit, who helped to formulate the NICE guidance, said that
the findings were "fantastically important" and that it was
"dangerous" for drug companies not to have to publish their full data.
He added: "Three of these drugs are some of the most commonly used
antidepressants in this country. It's not mandatory for drug companies
to publish all this research. I think it should be."

SSRIs are not prescribed to patients under 18 because of the risk of
suicide.Drugs watchdogs in Europe are considering tighter controls on
the development of new medicines, The Times reported this month, and
may soon require regulators to monitor psychiatric effects and the
risk of suicide more closely during clinical trials.

A spokesman for GlaxoSmithKline, which makes Seroxat, said: "The
authors have failed to acknowledge the very positive benefits these
treatments have provided to patients and their families dealing with
depression and their conclusions are at odds with what has been seen
in actual clinical practice. This one study should not be used to
cause unnecessary alarm and concern for patients."

A spokesman for Eli Lilly, which makes Prozac, said: "Extensive
scientific and medical experience has demonstrated that fluoxetine is
an effective antidepressant."

(c) Copyright 2008 Times Newspapers Ltd.

This website is published by a member of the News International Group.
News International Limited, 1 Virginia St, London E98 1XY, is the
holding company for the News International group and is registered in
England No 81701. VAT number GB 243 8054 69.
news.chi.sbcglobal.net - 26 Feb 2008 05:12 GMT
The anti-depressants are the golden calf of pharm's  income.   Does anyone
expect the pharmaceuticals to say anything but the best for
anti-depressants.   No side effects?    deadly side effects that will cull
the population in institutions, everyday life, etc.   Read
DoctorBrains.org     comments on crohns/colitis by Kureforcrohns.    The
deaths from the mind/body connection of stimulants exceeds those of any
drugs that we have ever known.     I will say this over and over until
anti-depressants are known for their mysterious deadly aspect.
Gail Michael

The Times
February 26, 2008

Depression drugs don't work, finds data review
David Rose

Millions of people taking commonly prescribed antidepressants such as
Prozac and Seroxat might as well be taking a placebo, according to the
first study to include unpublished evidence.

The new generation of antidepressant drugs work no better than a
placebo for the majority of patients with mild or even severe
depression, comprehensive research of clinical trials has found.

The researchers said that the drug was more effective than a placebo
in severely depressed patients but that this was because of a
decreased placebo effect.

The study, described as "fantastically important" by British experts,
comes as the Government publishes plans to help people to manage
depression without popping pills.

More than £291 million was spent on antidepressants in 2006, including
nearly £120 million on SSRIs. As many as one in five people suffers
depression at some point. With that in mind, ministers will today
publish plans to train 3,600 therapists to treat depression. Spending
on counselling and other psychological therapies will rise to at least
£30 million a year.

The study, by Irving Kirsch, from the Department of Psychology at the
University of Hull, is the first to examine both published and
unpublished evidence of the effectiveness of selective serotonin
reuptake inhibitors (SSRIs), which account for 16 million NHS
prescriptions a year. It suggests that the effectiveness of the drugs
may have been exaggerated in the past by drugs companies cherry-
picking the best results for publication.

The National Institute for Health and Clinical Excellence (NICE),
which is due to review its guidance on treating depression, said that
it would consider the study.

Mental health charities say that most GPs admit that they are still
overprescribing SSRIs, which are considered as effective as older
drugs but with fewer side-effects. SSRIs account for more than half of
all antidrepressant prescriptions, despite guidelines from NICE in
2004 that they should not be used as a first-stop remedy.

American and British experts led by Professor Kirsch examined the
clinical trials submitted to gain licences for four commonly used
SSRIs, including fluoxetine (better known as Prozac), venlafaxine
(Efexor) and paroxetine (Seroxat).

The study is published today in the journal PLoS (Public Library of
Science) Medicine. Analysing both the unpublished and published data
from the trials, the team found little evidence that the drugs were
much better than a placebo.

"Given these results there seems little reason to prescribe antide-
pressant medication to any but the most severely depressed patients,
unless alternative treatments have failed," Professor Kirsch said.
"The difference in improvement between patients taking placebos and
patients taking antidepressants is not very great. This means that
depressed people can improve without chemical treatments." He added
that the study "raises serious issues that need to be addressed
surrounding drug licensing and how drug trial data is reported".

The data for all 47 clinical trials for the drugs were released by the
US Food and Drug Administration under freedom of information rules.
They included unpublished trials that were not made available to NICE
when it recommended the drugs for use on the NHS. "Had NICE seen all
the relevant unpublished studies, it might have come to a different
conclusion," Professor Kirsch said.

Tim Kendall, a deputy director of the Royal College of Psychiatrists
Research Unit, who helped to formulate the NICE guidance, said that
the findings were "fantastically important" and that it was
"dangerous" for drug companies not to have to publish their full data.
He added: "Three of these drugs are some of the most commonly used
antidepressants in this country. It's not mandatory for drug companies
to publish all this research. I think it should be."

SSRIs are not prescribed to patients under 18 because of the risk of
suicide.Drugs watchdogs in Europe are considering tighter controls on
the development of new medicines, The Times reported this month, and
may soon require regulators to monitor psychiatric effects and the
risk of suicide more closely during clinical trials.

A spokesman for GlaxoSmithKline, which makes Seroxat, said: "The
authors have failed to acknowledge the very positive benefits these
treatments have provided to patients and their families dealing with
depression and their conclusions are at odds with what has been seen
in actual clinical practice. This one study should not be used to
cause unnecessary alarm and concern for patients."

A spokesman for Eli Lilly, which makes Prozac, said: "Extensive
scientific and medical experience has demonstrated that fluoxetine is
an effective antidepressant."

(c) Copyright 2008 Times Newspapers Ltd.

This website is published by a member of the News International Group.
News International Limited, 1 Virginia St, London E98 1XY, is the
holding company for the News International group and is registered in
England No 81701. VAT number GB 243 8054 69.

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