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Regulation of drugs

A secretive system

Leader
Saturday March 13, 2004
The Guardian


At first glimpse this week's warnings from the Committee on the Safety of Medicines (CSM) that doctors should avoid prescribing Seroxat, Britain's best-selling anti-depressant drug, at higher doses than 20mg a day, looked like a regulatory body performing as it should: protecting patient interests. Alas, if only this was true. Yesterday, the curtain on an unseemly behind-the-scenes row was lifted by the resignation of Richard Brook, chief executive of the mental health charity Mind, from an expert group looking at Seroxat on which he was representing consumer interests. His reason for resigning was the failure of the regulator to be more open about the threats that high doses of the drug posed.

As our health editor reports today, about 17,000 patients - out of an estimated 500,000 on the drug - were started on doses higher than the recommended 20mg last year. The regulatory body believes higher doses are no more effective than the 20mg pill and carry the risk of increased side-effects. Patients and consumer groups have complained about a range of side effects: anxiety, nausea, heightened aggression and possible increased suicidal tendencies. There are even more complaints about the difficulty of coming off the drug, once having begun treatment, because of serious withdrawal symptoms. Worse still, it now appears that three major reviews of the drug failed to examine data more than 14 years old, that showed it was ineffective and unsafe at high doses. The drug's licence was granted in 1990, at a time when the regulatory authority to which the CSM reported, is understood not to have employed statisticians that were needed to make risk assessments.

Earlier this month the health minister announced that the role - and work - of the CSM was to be reviewed, but the task was given to the regulatory body (the Medicines and Healthcare Products Regulatory Agency) to which it reports. This is much too cosy. Something much more independent and robust is needed. There is nothing new about the regulator of the drugs industry being too close to the industry and too distant from patient interests. We need a more transparent and less secretive system. A first step would be an independent review.

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