Avandia should still be on the market, says GSK | InPharm

GlaxoSmithKline believes European regulators were wrong to withdraw its diabetes drug Avandia from the market, but will not challenge their decision.

Speaking exclusively to Pharmafocus, GSK’s UK medical director Dr Pim Kon said meta-analyses may have shown a ‘signal’ of cardiovascular side-effects four years ago, but she disputed the EMA’s interpretation of the data.

“We still believe Avandia is valuable to patients and has a positive benefit/risk ratio to type II diabetics,” she said.

Dr Kon was also clear GSK would not have acted any differently in retrospect, despite facing mounting criticism over its behaviour, including from the BBC’s Panorama programme and the British Medical Journal last month.

“We have acted responsibly and with integrity and I don’t see how we could have acted any differently,” she said.

Avandia was suspended by European regulator the EMA late last month because of high levels of heart attack, heart failure and stroke in patients, but its US counterpart the FDA has allowed it remain on the market, albeit with further restrictions on it use.

The EMA’s decision to order its withdrawal is the culmination of a long period of doubt about Avandia's side effects, with concerns growing after a meta analysis was published in the New England Journal of Medicine in May 2007.

Conducted by independent cardiologist Dr Steve Nissen, this meta-analysis of GSK’s available data showed a link between Avandia and both heart attacks and an increased risk of fatal cardiovascular events.

But GSK maintains a discrepancy between Nissen’s data and GSK’s own RECORD trial data meant the meta-analysis was not a true representation of the data.

“GSK looked at the data as a whole – the discrepancy exists in the interpretation of the data because we have looked at it differently,” Dr Kon said.

She admitted that this was “confusing for the public” as clinical data is difficult to interpret and many trials for Avandia have been undertaken with different endpoints.  

She confirmed GSK submitted 42 meta-analyses to the FDA in 2006 and, when pushed on the matter, said these data showed there “may be some signal of cardiovascular events”, but she added that in July 2007 an FDA committee said the drug had a positive benefit/risk ratio.

Responding to the accusation that the company had tried to bury negative data from its 2001 RECORD study of the drug, Dr Kon dismissed this saying GSK “acted responsibly”.

However, several emails between GSK executives in 2001 showed the company was willing to drop two negative studies from the RECORD study that showed a link between use of Avandia and cardiovascular events, as they would put the drug in a “negative light”.

Asked whether GSK has an internal policy to stop the distortion or ‘cherry picking’ of data, Kon said: “GSK is fully committed to transparency, but we cannot say 100% that it couldn’t happen. We are going in the right direction and I believe completely that we are a highly ethical company.”

Kon also noted that GSK publishes all of its clinical data for the public to see – something it was required to do after withholding important safety data on its antidepressant Seroxat back in 2008.

Ben Adams

via inpharm.com

Posted via email from Jack's posterous