The headline above comes from the UK’s Independent. I could have picked number of variants (BBC, “Anti-depressants ‘of little use‘,” Financial Times, “Antidepressants ‘have no impact‘”), but what is interesting is that as of this hour, this study, published by the University of Hull, is getting MSM coverage solely in the UK and Commonwealth countries.
The study was a meta-analysis of 47 published and unpublished clinical trials submitted to the FDA for the most popular category of antidepressants, the selective seratonin reuptake inhibitors (SSRIs), which include Prozac, Paxil, Zoloft, and Efexor. This study did not cover an older type of anti-depressant, bupropion (Wellburtin and Zyban). Bottom line: SSRIs are beneficial only for a very small group, the most severely depressed, and then only to a limited degree.
The cynic in me wonders both about regulatory regimes that allowed such marginal drugs to become blockbusters, and the US media for (as of now) failing to broadcast this finding. Comments from the lead researcher, Professor Irving Kirsch, indicate that it was difficult for him to get the data needed to perform the analysis.
From the Independent:
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….
In the study, researchers conducted a meta-analysis of all 47 clinical trials, published and unpublished, submitted to the Food and Drug Administration in the US, made in support of licensing applications for six of the best known antidepressant drugs, including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 A third drug, chemical name nafazodone, has been withdrawn from the market because of side-effects.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…..
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.”