Healthy Skepticism Library item: 21

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Publication type: news

Boseley S.
Antidepressants to be ruled safe: Watchdog criticised for today's announcement
The Guardian 2004 Dec 6

Full text:

The government’s medicines watchdog is expected to rule today that most of the controversial modern antidepressant drugs, such as Prozac and Seroxat, are safe for adults, despite psychiatrists and users expressing extreme concern that it has not seen the full data on side-effects. The Medicines and Healthcare Products Regulatory Authority (MHRA) appointed an expert working group two years ago to investigate the drugs’ safety, after it was claimed that they could make people feel aggressive and suicidal, and that some users experienced distressing symptoms if they tried to come off them. Last December the MHRA banned all but one drug, Prozac, from being prescribed to children under 18, after all the clinical trial data, which extended further than the papers published by the drug companies, had been scrutinised. The new data showed that the drugs did cause some children to feel hostile and suicidal, and that they were no better at alleviating childhood depression than a placebo – a dummy pill. Today’s MHRA announcement will clear most of the drugs known as SSRIs (selective serotonin reuptake inhibitors) for use by adults, with the probable exception of venlafaxine, which is already recognised as having problematic side-effects. But senior psychiatrists and the user group involved in the review are deeply troubled that the MHRA has made its decision without seeing raw data from the unpublished trials. The MHRA has confirmed to the Guardian that most of the data supplied to it has been in the form of drug companies’ summaries, plus “some individual case reports”. When what should be the final verdict on the drugs is announced today there will be no representatives there from the Royal College of Psychiatrists and the mental health charity Mind, whose chief executive, Richard Brook, resigned from the MHRA in March, accusing it of sitting on evidence that Seroxat had been prescribed in unsafe doses for 10 years. GlaxoSmithKline has posted the results of its Seroxat trials on children on its website, in response to criticism about the lack of publication. But David Healy, professor of psychiatry and director of the North Wales department of psychological medicine, said even that information was incomplete. Company summaries of trial results were not adequate, he argued. “In the case of just one drug, sertraline [brand name Lustral], I have seen at least three different summaries of the data during a two year period, covering the same set of trials”, he said. GlaxoSmithKline is being investigated for an alleged failure to disclose information about risks to children it would have known about for several years before it told the MHRA. It is thought that the unpublished trials of all the SSRIs on adults outnumber published results by eight to one. Mr Brook said: “It’s amazing that the inquiry was set up two years ago and the MHRA has still not seen the original data. This surely raises questions about their ability to get to the heart of the matter.” The MHRA says it would not have been possible to study all the original data, because of the sheer amount. “We would be looking at years,” a spokeswoman said. “It is just not feasible.”