Wednesday, February 27, 2008

Two British Articles on Antidepressants

Antidepressant drugs don't work – official study
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.
In the study, researchers conducted a meta-analysis of all 47 clinical trials, published and unpublished, submitted to the Food and Drug Administration in the US, made in support of licensing applications for six of the best known antidepressant drugs, including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 A third drug, chemical name nafazodone, has been withdrawn from the market because of side-effects.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.

The drug industry's long and ignoble history of secrecy
By Jeremy Laurance, Health Editor
Wednesday, 27 February 2008
Discovering, testing and bringing a new drug to market can take more than a decade and cost as much as £500m. Over the past 30 years, as the costs have mounted, so have the pressures to protect new chemical agents which could become potential blockbusters.

Secrecy became the pharmaceutical industry's watchword as it sought to control publication of trials and even manipulate results. Cancer drugs introduced in the 1990s claimed to offer major benefits which later turned out to be more apparent than real. Evidence published in The Journal of the American Medical Association showed that 38 per cent of independent studies of the drugs reached unfavourable conclusions about them, compared with just 5 per cent of studies funded by the pharmaceutical industry.

In 2004, UK researchers commissioned by Nice to develop guidelines for prescribing antidepressant drugs to children tried to obtain unpublished trials from the drug companies. They were refused. They then contacted the individual researchers who had worked on the trials. Only then did a picture emerge of increased risk of attempted suicide, and a lack of efficacy. Nice concluded by banning the drugs for under-18s with the exception of Prozac.

Yesterday's report suggesting that modern antidepressants offer no significant clinical benefit over placebo has been dismissed by the drug industry as "just one study" which should not be allowed to undermine the wealth of research showing that the selective serotonin reuptake inhibitor (SSRI) antidepressants are effective.
But that is to miss the point. The Hull University researchers have demonstrated how partial access to research can give a distorted view of a drug. The non-disclosure of data on the SSRIs has raised doubts about the trustworthiness of all research on antidepressants.

We should be relieved that the licensing authorities have an absolute right to see all trial data, positive and negative, before approving a drug. But, bizarrely, Nice, with the responsibility for deciding which drugs should be used by the NHS, only gets what the drug companies agree to give it. The Health Select Committee has called for action to remedy this omission. Ministers must respond.

1 Comments:

At 10:52 PM, Blogger Mark said...

I tagged you!
LINK

 

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