News

Mental health and consumer campaigners have told MPs that Britain’s “weak and uncoordinated” system of drugs regulation poses a risk to patients, writes Craig Kenny.

Mind’s chief executive Richard Brook resigned from the Medicines and Healthcare Regulatory Agency last year due to his concerns over evidence of suicide risks from the anti-depressants Seroxat and Effexor in children. The manufacturers had withheld the trial data for two years.

After both drugs were banned for use in children, a Department of Health official visited the MHRA to voice concern that “we no longer have anything to prescribe to children,” Brook told Parliament’s Health Committee last week.

He described his time at the MHRA as “scary and painful.”

“Every time we made a difficult decision there was always this issue that the pharmaceutical company would sue us if we got it wrong. That dimension was always more on the minds of officials than the interests of patients.”

He added: “The MHRA threatened me with prosecution…I am still somewhat fearful of the MHRA’s approach to me.”

Brook also criticised the MHRA for not obtaining data on adverse drug reactions from other countries’ regulators.

Professor Andrew Herxheimer of the UK Cochrane Centre, Oxford, argued that responsibility for monitoring adverse drug reactions should be taken away from the MHRA and given to an independent agency, funded by a tax on drug sales.