Mind calls for better regulation of drugs in wake of evidence against GSK

Posted Tuesday 3 February 2004

Commenting on the revelation in The Guardian that Glaxo SmithKline held back unfavourable trials data on the effect of the anti-depressant Seroxat on children, Richard Brook, Chief Executive of Mind said:

"That a globally renowned company such as GSK was apparently willing to put children at risk for commercial gain is shocking enough. That UK drugs regulations are such that they are unequipped to prevent potentially dangerous medication being prescribed to many thousands of youngsters is perhaps worse.

The MHRA (Medicines and Healthcare products Regulatory Agency) does not listen hard enough to those who know most about health problems associated with taking SSRIs - the people who have actually been prescribed them and are experiencing side effects.

In short, drugs regulation in the UK needs to be tougher, more responsive to consumers and completely independent of undue political and commercial interests."

Although Seroxat was not licensed for the treatment of children in the UK, some 10,000 children were prescribed the drug up until its use in under-18s was banned in June 2003.

Last year Mind expressed concern that the MHRA was not being proactive enough in seeking clinical trials data from companies such as GSK on the effectiveness and safety of drugs including Seroxat.

Mr Brook was speaking from a fact finding trip to Washington DC where he is currently hearing evidence presented to the Food and Drugs Administration on SSRIs amid concerns that drugs companies are seeking to discredit users’ experiences.

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