[Ip-health] Antidepressant drugs don't work – official study

[Ira Glazer]

http://www.independent.co.uk/life-style/health-and-wellbeing/health-news/an=
tidepressant-drugs-udontu-work-ndash-official-study-787264.html

< The finding will send shock waves through the medical profession and
patients and raises serious questions about the regulation of the
multinational pharmaceutical industry, which was accused yesterday of
withholding data on the drugs.>

< In the study, researchers conducted a meta-analysis of all 47 clinical
trials, published and unpublished, submitted to the Food and Drug
Administration in the US, made in support of licensing applications for
six of the best known antidepressant drugs, including Prozac, Seroxat –
which is made by GlaxoSmithKline – and Efexor made by Wyeth. The results
showed the drugs were effective only in a very small group of the most
extremely depressed.>

< Professor Kirsch said: "Given these results, there seems to be little
reason to prescribe antidepressant medication to any but the most
severely depressed patients, unless alternative treatments have failed
to provide a benefit. This study raises serious issues that need to be
addressed surrounding drug licensing and how drug trial data is reported.">

< Tim Kendall, deputy director of the Royal College of Psychiatrists'
research unit, said the findings, if proved true, would not be
surprising. As head of the National Collaborating Centre for Nice
guidelines on mental health, he said it had proved impossible to get
access to unpublished trials in the past.  "The companies have this data
but they will not release it. When we were drawing up the guidelines on
prescribing antidepressants to children [in 2004] we wrote to all the
companies asking for it but they said no. The Government pledged in its
manifesto to compel the drug companies to give access to their data but
that commitment has not been met." >


By Jeremy Laurance, Health Editor

26/02/08

They are among the biggest-selling drugs of all time, the "happiness
pills" that supposedly lift the moods of those who suffer depression and
are taken by millions of people in the UK every year.
But one of the largest studies of modern antidepressant drugs has found
that they have no clinically significant effect. In other words, they
don't work.

The finding will send shock waves through the medical profession and
patients and raises serious questions about the regulation of the
multinational pharmaceutical industry, which was accused yesterday of
withholding data on the drugs.

It also came as Alan Johnson, the Health Secretary, announced that 3,600
therapists are to be trained during the next three years to provide
nationwide access through the GP service to "talking treatments" for
depression, instead of drugs, in a £170m scheme. The popularity of the
new generation of antidepressants, which include the best known brands
Prozac and Seroxat, soared after they were launched in the late 1980s,
heavily promoted by drug companies as safer and leading to fewer
side-effects than the older tricyclic antidepressants.

The publication in 1994 of Listening to Prozac by Peter Kramer, in which
he suggested anyone with too little "joy juice" might give themselves a
dose of the "mood brightener" Prozac , lifted sales into the stratosphere.

In the UK, an estimated 3.5 million people take the drugs, collectively
known as selective serotonin reuptake inhibitors (SSRIs), in any one
year and 29 million prescriptions were issued in 2004. Prozac, the best
known of the SSRIs made by Eli Lilly, was the world's fastest-selling
drug until it was overtaken by Viagra.

In the study, researchers conducted a meta-analysis of all 47 clinical
trials, published and unpublished, submitted to the Food and Drug
Administration in the US, made in support of licensing applications for
six of the best known antidepressant drugs, including Prozac, Seroxat –
which is made by GlaxoSmithKline – and Efexor made by Wyeth. The results
showed the drugs were effective only in a very small group of the most
extremely depressed.

Two drugs were excluded from the study because of incomplete data. A
third drug, chemical name nafazodone, has been withdrawn from the market
because of side-effects.

Professor Irving Kirsch of the University of Hull, who led the study
published in the online journal Public Library of Science (PLoS)
Medicine , said the data submitted to the FDA would also have been
submitted to the licensing authorities in Britain and Europe. It showed
the drugs produced a "very small" improvement compared with placebo of
two points on the 51-point Hamilton depression scale.

That was sufficient to grant the drugs a licence but did not meet the
minimum three-point difference required by the National Institute for
Clinical Excellence (Nice) to establish "clinical" significance. Yet
Nice approved the drugs for use on the NHS in the UK because it only had
access to the published trials, which showed a larger effect.

Professor Kirsch said: "Given these results, there seems to be little
reason to prescribe antidepressant medication to any but the most
severely depressed patients, unless alternative treatments have failed
to provide a benefit. This study raises serious issues that need to be
addressed surrounding drug licensing and how drug trial data is reported."

Five years ago, there were allegations that antidepressant drugs were
addictive and could trigger suicides. All but Prozac were banned for
children, although a major investigation on the safety of medicines
cleared them of causing suicide in adults.

Alternative treatments for depression, such as counselling or physical
exercise , should be tried first, Professor Kirsch said. The
pharmaceutical companies had withheld data that was available to the
licensing authorities so that doctors and patients did not understand
the true efficacy, or lack of it, of the drugs.

"This has been the frustration. It has made it very difficult to answer
the question of whether the drugs work. The pharmaceutical companies
should be obliged when they get a drug licensed to make all the data
available to the public. When you analyse all the trials of these SSRIs,
both published and unpublished, it leads you to more sober conclusions,"
he said.

Tim Kendall, deputy director of the Royal College of Psychiatrists'
research unit, said the findings, if proved true, would not be
surprising. As head of the National Collaborating Centre for Nice
guidelines on mental health, he said it had proved impossible to get
access to unpublished trials in the past.

"The companies have this data but they will not release it. When we were
drawing up the guidelines on prescribing antidepressants to children [in
2004] we wrote to all the companies asking for it but they said no. The
Government pledged in its manifesto to compel the drug companies to give
access to their data but that commitment has not been met."

The new finding would make doctors "much more cautious about prescribing
the drugs," Mr Kendall added.

GlaxoSmithKline, makers of Seroxat, said the authors of the study had
"failed to acknowledge" the very positive benefits of SSRIs and their
conclusions were "at odds with the very positive benefits seen in actual
clinical practice." A spokesperson added: "This one study should not be
used to cause unnecessary alarm for patients.

Lilly said in a statement: "Extensive scientific and medical experience
has demonstrated that fluoxetine [Prozac] is an effective antidepressant.

Wyeth said: "We recognise the need for both pharmacological and
non-pharmacological treatments for depression."

On the new training for therapists, Mr Johnson said the programme
signalled a decisive shift away from drugs in favour of non-drug
treatments for depression. "We are not taking the decision away from
clinicians," he said.

"For many, medication is successful. But talking therapies can have
dramatic effects. We have put a lot of emphasis on medication in the
past and it is about time we redressed the balance and put more emphasis
on talking treatments."