March 15, 2004

The chief executive of the mental health charity MIND has resigned from a government expert working group reviewing the safety of antidepressants, accusing it of negligence

Richard Brook claims the Medicines and Healthcare Products Regulatory Agency (MHPRA) knew about concerns over Seroxat for 10 years but took no action.

Mr Brook, a lay member of the working group investigating selective serotonin reuptake inhibitors (SSRIs), of which Seroxat is one, accused the MHPRA - which licenses drugs for use in the UK - of failing in its duty by not acting on data showing that thousands of people were taking unsafe doses of Seroxat.

Last week the Committee on Safety of Medicines, which advises the MHPRA, warned doctors to keep to 20mg when prescribing the drug to new patients with most types of disorder. Around 17,000 people were given higher doses last year, which could increase the risk of side-effects such as insomnia and nausea.

Doctors have also been advised that children and under-18s should not be prescribed Seroxat, which can be addictive and increase the risk of violent behaviour in some people.

Mr Brook said: "On Thursday [last week] the agency at last published information advising that many thousands of men and women in this country may have been taking Seroxat at a dose that was unsafe.

"What it failed to mention is that the regulator had the data on which the basis of this decision was made for well over a decade as part of the original licence application.

"Despite four major regulatory reviews during this period and considerable consumer reporting and disquiet, the Committee of Safety of Medicines failed either to identify or communicate these key facts. As far as I am aware, the MHPRA has not seen fit to acknowledge or address what in my view appears to be extreme negligence.

"Either they didn't understand the full implications of the available medical data at the time or, worse, that data was fully understood and they failed to act."

MIND is calling for an independent review of the workings of drug regulation with patient representation at its heart. They were supported by Charles Medawar of the consumer group Social Audit.

Mr Medawar told the Guardian newspaper. "Richard Brook's brave resignation is enormously significant, and the loss of the one independent consumer figurehead now calls into question the whole credibility of the CSM's review,"

"Brook's resignation pretty much mandates a formal parliamentary investigation of the UK medicines control system.

"The drug regulators have made a series of bad errors; it is completely unacceptable that they should be now allowed to investigate their own mistakes."

Richard Brook's letter to the Medicines and Healthcare Products Regulatory Agency (pdf)

March 15: Keep Seroxat dose low, doctors told - reported in the Guardian

See also:
Feb 8, 2004: GlaxoSmithKline 'held back' data on SSRI anti-depressants for children - latest developments in the SSRI controversy. Plus, advisers to the US Food and Drug Administration warn that SSRIs may increase suicidal thinking among children
June 14, 2003: Seroxat banned for under-18s - the latest from the Guardian
May 10, 2003: GPs accused of not reporting Seroxat suicides - reports the Guardian

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