Is Glaxo going to get away with it… again?
After the scandal of Seroxat – an unsafe drug with dangerous side effects, that made billions in profit and gained a licence using dodgy data supplied by GlaxoSmithKline, we now have the Avandia scandal: the story of an unsafe drug with dangerous side effects, that made billions in profit and gained a licence using dodgy data supplied by GlaxoSmithKline.
See a pattern forming?
Two days ago, the British Medical Journal (BMJ) said Avandia should never have been licensed in Britain and should now be withdrawn, after medical experts advised that its risks “outweigh its benefits”.
The drug – also known as Rosiglitazone – was approved by the European Medicines Agency ten years ago to help lower blood sugar levels in patients with type two diabetes. However, the BMJ’s investigations editor, Dr Deborah Cohen, said the European drug approval process was not rigorous enough and raised concerns about the quality of data used by Glaxo SmithKline.
The journal said that no new patients should start taking the drug, while those already taking it should consult their GP. It said that those at a higher risk of heart disease should be advised to stop taking it.
But now it has emerged that the Commission on Human Medicines advised the Medicines and Healthcare products Regulatory Agency (MHRA) in July that Avandia “no longer has a place on the UK market” and should be withdrawn, as its risks outweighed its benefits.
The Commission’s advice has been revealed following an investigation by the BMJ in collaboration with the BBC Panorama programme. Dr Yoon Loke, a clinical pharmacologist based at the University of East Anglia, told Panorama that the drug could have caused an extra 1,000 heart attacks and about 600 extra cases of heart failure in the UK last year.
However Professor Donald Singer of the British Pharmacological Society said that patients should not be concerned in the short term. In what appears to be a confused statement he says “These are not acceptable risks in the long term and you scale up in the country, clearly that could lead to many hundreds of people being affected. But from day to day, the actual risk to a given patient is quite small.”
Thanks for clearing that up Donald… ?