MCA playing russian roulette with lives, says charity
pharmafile | October 29, 2003 | News story | Sales and Marketing |Â Â Â
Mental health charity MIND has criticised the way the Medicines Control Agency handles drug regulation, saying it is "playing Russian roulette with people lives".
The charity's attack focuses on the limitations of the regulator's safety reporting system in the wake of the furore surrounding the safety of GlaxoSmithKline's antidepressant Seroxat.
Chief Executive of MIND, Richard Brook, said the MCA (now the Medicines and Healthcare products Regulatory Agency) was not paying attention to people who have taken the drug but instead listened to "selective evidence" produced through its yellow card safety monitoring scheme.
The charity has now called for an in-depth discussions on Seroxat and the SSRI class in general, how patient experiences can be more pro-actively gathered, and the role of the MHRA.
It called for the withdrawal of Seroxat for new prescriptions pending an independent review of the drug and the experiences of people taking it, stronger warnings about withdrawal problems and better training for GPs and psychiatrists for the prescribing of all psychiatric drugs and provision of non-drug treatments.
It has also demanded meetings with Health Minister Hazel Blears, GSK's Chief Executive, the National Institute for Mental Health, the Royal College of GPs and the Royal College of Psychiatrists.
Numerous patients have reported serious side-effects when they try to come off the medication, but GSK has repeatedly said that this does not mean Seroxat causes addiction or dependency.
GSK now admits that patients do not fully understand the wording of the PIL, and has decided to remove the leaflet's claims that the drug is not addictive and strengthen the information on side-effects.
But the company remains adamant that the drug is not addictive and will still keep this information on a separate information sheet for doctors.
A recent Panorama programme, 'emails from the Edge' examined patient experiences of Seroxat and was a follow-up to an earlier programme broadcast in October, on which Dr Alastair Benbow, GSK's Head of European Clinical Psychiatry, said Seroxat was not addictive according to the medical definition.
On 'emails from the Edge', Dr Benbow said he had "every sympathy" for any patient suffering from side-effects, and that changes to the PIL would ensure there would be "greater clarity in terms of the exact wording".
He also denied claims that Seroxat is responsible for self-harm and suicidal behaviour in patients who have otherwise not shown such behaviour.
Charles Medawar of health consumer group Social Audit, and pharmacologist Dr Andrew Herxheimer analysed almost 1,400 e-mails from Seroxat patients and their families received by the Panorama programme.
They found that 16 patients had committee suicide while taking Seroxat over the last two years, compared with six reports received by the MCA. They concluded that such patient experiences, and those obtained though Internet discussion forums, were a valid tool for drug monitoring and could even be more valuable than the current "variable trickle" of reports through the yellow card scheme.
Richard Brook said the difference indicated how poor the current safety reporting system was.
"Mind has been campaigning for many years to try to get the drug regulators to take the experiences of people who are taking prescribed drugs seriously", he said. "Finally we have the right kind of attention given to this appalling state of affairs, and we want to see the MHRA promote the yellow card scheme far more widely, not just bury their heads in the sand and put people lives at risk.
"The fact that a BBC programme gets more reports of deaths believed to be related to a drug than the drug regulator itself highlights just how much more work the MHRA must do to fulfil their duty".
