Calls for inquiry on dangers of Seroxat

The chief executive of the mental health charity Mind, who resigned from an expert panel in protest at a "cover-up" over unsafe prescribing of anti-depressants, was last night demanding a government inquiry into the relationship between pharmaceutical companies and independent drugs regulators.

Richard Brook claims that the body responsible for licensing drugs, the Medicines and Healthcare Products Regulatory Agency (MHRA), has known for more than 10 years that doctors have been handing out too high doses of the anti-depressant Seroxat, increasing the risk of suicide.

Mr Brook, who stepped down on Friday from the working group set up to investigate the side effects of Seroxat and Prozac, said "immediate answers" were needed to questions surrounding the independence of the MHRA.

"Justice for the British consumer can only be done by the Government announcing a full independent inquiry into drugs regulation," he said. "As things stand the interests of pharmaceutical companies have far too strong a voice."

His resignation comes amid increasing concerns about the side effects of Seroxat, which belongs to a class of drugs known as selective serotonin re-uptake inhibitors, or SSRIs. Last year, 17,000 people were put on daily doses above the recommended 20mg.

In June last year, drug regulators did move to ban prescription of Seroxat to people under 18 following evidence that it can cause young people to become suicidal. This followed a BBC Panorama report which revealed 16 cases of suicides that bereaved families said were linked to the drugs, 47 attempted suicides and 92 cases of patients who had thought of harming themselves or others.

GlaxoSmithKline, which makes Seroxat, has denied any connection between the drug and an increased risk of suicide. Dr Alastair Benbow, the European medical director at Glaxo, said: "There are many reasons for suicide, and there is no compelling evidence that Seroxat causes suicide in adults. In fact, clinical trials have shown that Seroxat reduces the occurrence of suicide, particularly in adults who are prone to it."

Mr Brook has also attacked the Government's advisory group, the Committee on Safety of Medicines, which advises the MHRA on which drugs to license, for failing to act on concerns he expressed to them last October about unsafe prescribing. Yesterday, MPs and health experts called on pharmaceutical companies to release data from drug trials so the public can form their own opinion about safety and for an overhaul of the system of drug regulation, which is shrouded in secrecy.

David Hinchliffe, the MP who chairs the Health Select Committee, said the Government needed to act to reassure the public. "In view of the anxieties over ... SSRIs, in the interests of those people who are using these products, they need reassurance," he said.

Dr David Healy of the University of Wales College of Medicinebacks calls for people to have access to full results of clinical trials and wants consumers to be able to report side effects to the MHRA."We track parcels better than we track patients who are using these drugs," he said.

OPINION

Seroxat saved my life. It's as stark - and stupidly melodramatic - as that. I was 18, lost and suicidal. I couldn't sleep; I couldn't eat; I could only think fitfully, in manic bursts, in between tears. And then came my small blue tablets - 30mg of sanity once a day.

Seven years on, I have never once doubted my Seroxat. I have found coherence and control. No more waking up crying without an explanation. No more despair...

On this issue, I fear Richard Brook has made a rare misjudgement. Two months ago, my GP refused me a repeat prescription, for the first time, and said I would have to come off the drug over three months.

"I do not know why you are even taking anti-depressants. You do not look depressed to me," she said. "I don't look depressed, doctor, because I am taking anti-depressants." Her response was to read me the NHS guidelines for GPs. If after six months the patient is not showing further symptoms of depression, stop giving out the drug, it says. If the drugs work, stop prescribing them.

I can afford to go to an understanding private psychiatrist. But for other people, these restrictions will lead back to darkness.

Johann Hari