Pressure mounts on GSK over Avandia
pharmafile | September 6, 2010 | News story | Sales and Marketing | Avandia, GlaxoSmithKline
GlaxoSmithKline is under mounting pressure this week as calls intensify for its type II diabetes drug Avandia to be withdrawn in Europe.
A BBC Panorama documentary tonight will say Avandia (rosiglitazone), which has been linked to greater risk of heart problems, is still being prescribed on the NHS despite European regulators recommending its removal from the market two months ago.
GSK is also the subject of an editorial in the British Medical Journal, which says it is “deeply” worrying that US and European regulators “still decline to demand proof of cardiovascular safety before licensing drugs for type II diabetes”.
Avandia has been contra-indicated in patients with heart failure or a history of heart failure since its first authorisation in 2000.
The BBC quotes Professor Edwin Gale, who chairs the European Medicines Agency scientific advisory group on diabetes, saying of rosiglitazone: “How long do you wait? How important is it to be absolutely certain and at what point do you start saying – this game isn’t worth it, people’s lives may be at risk, something should be done about it?”
The manufacturer says it has not seen the programme but “denies any suggestions that it has put patients at risk”.
“We continue to believe that Avandia is safe and effective when it is prescribed appropriately,” its statement adds.
The editorial in the British Medical Journal this week says it is a ‘scandal’ that, although Avandia was prescribed to reduce the serious consequences of type II diabetes, “we still cannot accurately quantify the harm to which we were exposing our patients”.
“If the regulatory bodies do not insist on definite evidence of greater benefit than harm to patients … they are failing in their basic purpose,” it concludes.
GSK refutes the BMJ’s editorial, saying: “GSK has carried out an extensive research programme involving more than 50,000 patients to analyse the safety and benefits of rosiglitazone.”
It argues that no other diabetes medicine introduced in the last ten years “has such an extensive safety database”.
The Panorama programme is understood to feature an audio recording of a meeting about Avandia between GSK experts and Dr Steve Nissen on 10 May 2007, which GSK says was covertly recorded.
The BBC’s pre-publicity materials suggest the recording is the “secret tape the drug company would rather you didn’t hear”.
Following a subpoena, GSK obtained a copy of the full two-hour recording on Friday and today posted it on its corporate website, where it can be downloaded here. The company said it took this step “so that all interested parties can hear all the comments made at this meeting in their full context”.
“For our part, we regret if any comments made by GSK during this meeting might be misinterpreted as seeking to stifle an independent view of the science around Avandia,” it adds.
Meanwhile, European regulatory advisors at the Committee for Medicinal Products for Human Use (CHMP) are meeting on Wednesday this week as part of the review started in July to look at the benefits and risks of Avandia as well as GSK’s other rosiglitazone-containing medicines Avandamet and Avaglim.
The review is expected to be finalised after the CHMP’s next scheduled meeting, which should conclude on 23 September.
Avandia was initially authorised in the European Union in July 2000 as second-line type II diabetes treatment to be used when others have failed or are unsuitable.
It was subsequently approved in combination with metformin as Avandamet and with glimepiride as Avaglim, and restrictions have been placed on their use subsequently by new packaging warnings.
“We have rigorously shared our data relating to the cardiovascular safety of Avandia in a timely and transparent manner and have made extensive efforts to publish our clinical trial findings in peer review journals, at scientific meetings and via our own clinical trials website,” says GSK.
Adam Hill
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