The timing could have almost been scripted. No sooner had an FDA panel downplayed historic safety fears over GSK's Avandia than a new diabetes drug safety scare has reared its head. A paper, published this morning in the British Medical Journal, details the results of a joint investigation between the BMJ and Channel 4 Dispatches into the potential proliferative or inflammatory effects of GLP-1 based diabetes drugs on the pancreas, and asks whether evidence for the link has been underplayed and the regulators slow to react.
Their investigation reportedly uncovered unpublished data that pointed towards unwarranted effects of the drugs on the pancreas, and that despite published reports indicating safety concerns, companies had not performed certain critical safety studies, nor had regulators requested them to do so.
On their own, states the BMJ piece, the individual pieces of unpublished evidence might seem inconclusive, but when considered alongside other emerging and long standing evidence, a "more coherent and worrying picture emerges".
The BMJ article highlights that three publications this year have raised safety concerns about GLP-1 based drugs, and as such both the FDA and EMA have launched a review into whether the drugs may be linked to pancreatic cancer.
The evidence, says the BMJ, is "fiercely contested" amongst scientists and manufacturers, with some arguing that the evidence against the drugs is weak. Still, the BMJ asks whether companies and regulators have done enough to address these safety concerns, and whether the doctors and patients have been adequately warned.
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For the time being, it seems that while we still can't be certain whether such a link does exist, the article raises a key issue relating to transparency and the sharing of data. Dr Fiona Godlee, Editor in Chief said: “All drug licensing is about balancing benefits and risks. But instead of engaging in open debate about legitimate and important scientific questions, the manufacturers have been unwilling to share their data. Meanwhile patients and doctors have not been kept properly informed about the uncertainties surrounding these drugs.” She added: “The debate would be much easier to resolve if all the information was placed in the public domain so scientists, doctors and ultimately patients could make up their own minds.”
Given the fate suffered by GSK's Avandia after some apparently unfounded safety concerns, it seems more important than ever to really get this one right. Already the stories are published across the UK newspapers (Express: "Is diabetes super drug a cancer risk for two million people?"; The Times: "Safety fears over diabetes drug âlinked with cancer'"), something which will no doubt be of extreme concern to all patients taking an otherwise effective drug.
If you want to know more about drug safety and addressing the key challenges for safety professionals, you might be interested in attending the World Drug Safety Congress Europe 2013, 10-12 September 2013, London.
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