(02/26/2008 - London Times) Depression drugs don’t work, finds data review

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antidepressants such as Prozac and Seroxat might as well be taking a placebo, according to the first study to include unpublished evidence.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

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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Irving Kirsch, from the Department of Psychology at the University of Hull, is the first to examine both published and unpublished evidence of the effectiveness of selective serotonin reuptake inhibitors (SSRIs), which account for 16 million NHS prescriptions a year.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 Analysing both the unpublished and published data from the trials, the team found little evidence that the drugs were much better than a placebo.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 antidepressant 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.

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(02/26/2008 - London Telegraph) Anti-depressants 'no better than dummy pills'

Millions of Britons are taking anti-depressants for no reason, according to a study that found they made little difference to the condition.

Researchers discovered the drugs, which cost the taxpayer almost £300 million a year, generally work no better than dummy pills, and said exercise and therapy should first be prescribed instead.

Only a small group of patients with extreme depression showed any beneficial effect, the team from the University of Hull reported.

Prof Irving Kirsch, the lead researcher, said: "In the best interests of patients it is time for a change of emphasis to non-drug treatments and reserve these drugs for very severely depressed patients."

In England 31 million prescriptions were written for anti-depressants in 2006. More than half were for Selective Serotonin Reuptake Inhibitors (SSRI).

The study, published in the journal Public Library of Science: Medicine, looked at the results of 35 clinical trials in the US involving 5,000 patients taking SSRIs, including Prozac, Efexor and Seroxat.

Prof Kirsch said patients taking the drugs did improve, but so did those on a placebo - showing most of the effect was psychological. He added: "One of the problems with anti-depressants is the risk of side-effects, such as an increased potential for suicide. Given that risk, it is important to know there are alternatives that seem to do as well or nearly as well but without the side-effects."

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(02/26/2008 - BBC) Anti-depressants 'of little use'

New generation anti-depressants have little clinical benefit for most patients, research suggests.

A University of Hull team concluded that the drugs helped only a small group of the most severely depressed.

Marjorie Wallace, head of the mental health charity Sane, said that if these results were confirmed they could be "very disturbing".

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The researchers found that even the positive effects seen on severely depressed patients were relatively small, and open to interpretation.

The seemingly good result came from the fact that these patients responded less to dummy pills (placebos) which they were given during trials, rather than any notable response to anti-depressants.

Lead researcher Professor Irving Kirsch said: "The difference in improvement between patients taking placebos and patients taking anti-depressants is not very great. This means that depressed people can improve without chemical treatments. Given these results, there seems little reason to prescribe anti-depressant medication to any but the most severely depressed patients, unless alternative treatments have failed to provide a benefit."

Professor Kirsch said the findings called into question the current system of reporting drug trials.

Dr Tim Kendall, deputy director of the Royal College of Psychiatrists Research Unit, has published research concluding that drug companies tend only to publish research which shows their products in a good light. He said the Hull findings undermined confidence in the ability to draw meaningful conclusions about the merit of drugs based on published data alone. He called for drug companies to be forced to publish all their data.

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Categories: 2008, SSRIs, Depression, Fluoxetine