Drug regulation a threat to patients

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

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

“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

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.


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