Antidepressant drugs don't work – official study

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Antidepressant drugs don't work – official study

Independent.co.uk

Tuesday, 26 February 2008

 

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clinical trials, published and unpublished, submitted to the Food and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. "

 

The treatments that do work

 

* Exercise: Helps some people with depression. Douglas Adams, author

of The Hitchhiker's Guide to the Galaxy, said running helped him cope

with depression.

 

* Friends: Talking through your feelings can help in mild depression

with a friend or relative or in a self-help group.

 

* Cognitive behavioural therapy: Teaches you to challenge negative

thoughts and feelings of hopelessness.

 

* Interpersonal therapy: Focuses on relationships and problems such

as difficulties with communication.

 

* Counselling: Helps you think about the problems in your life and

find new ways of dealing with them.

 

* Antidepressants: Increasingly seen as a second-line treatment, if

exercise or talking treatments do not work.

 

 

Independent

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