GlaxoSmithKline, the UK's biggest drug maker, faces a showdown over its blockbuster diabetes drug Avandia, which could result in the product being pulled from the market in the US and expose the company to billions of dollars in lawsuits.
The drug maker will today present a defence of Avandia's safety in front of a make-or-break scientific panel, which is meeting to discuss whether it increases patients' risk of having a heart attack or a stroke.
The issue has become politically charged in the US, where the future of Avandia is being seen as a test of the new management at the Food and Drug Administration, the medicines regulator, whose scientists have been split over what to do. Lawmakers on Capitol Hill have held hearings into the quality of GSK's science and its actions as the controversy over the drug has mounted. European regulators are also once again reviewing whether to keep Avandia on the market.
Lawyers representing thousands of patients who claim they suffered heart problems because of the drug are poring over documents released by the FDA last week. These revealed that some FDA scientists are sceptical over the quality of a GSK study, called the Record study, which showed Avandia patients were no more likely to have heart problems than other diabetes sufferers. The trial "was inadequately designed and conducted to provide any reassurance", the FDA's Thomas Marciniak wrote. A different FDA scientist, however, came to an alternative conclusion, and GSK says it stands by the Record study and that a further five studies all came to the same result: Avandia is safe.
Plaintiffs' lawyers, meanwhile, were yesterday arguing that the latest FDA advisory panel may not have all the relevant scientific information, saying they have seen additional documents showing the dangers of Avandia but which are being kept secret by the courts until the cases come to trial.
"We think there are very important documents involved," said Joseph Zonies, one of the lead lawyers in a case against GSK in US federal court.
Sales of Avandia collapsed in 2007 after concerns were raised by the eminent cardiologist Steve Nissen, who studied reported incidents of heart attacks and strokes among patients and concluded that Avandia raised the risks. US sales of Avandia accounted for only 1.5 per cent of GSK's total revenue last year and are still falling, but analysts said a negative decision by the FDA would embolden lawyers pursuing product liability claims.
Mike Ward, a pharmaceuticals industry analyst at Ambrian Partners, said the new documents had nothing "knocking the lights out as being statistically significant" against Avandia but that "diehard sceptics are not likely to be persuaded out of their view that the product causes problems".
"There will be more attempts to get cases going by hard-headed lawyers, but it seems to me that GSK could defend themselves pretty effectively."
The company has never said how many lawsuits it faces over Avandia, or how much of its £2.3bn legal claims fund has been set aside over this one drug. The two-day hearing starts this morning. The FDA does not have to follow the recommendation of the panel, but usually does.Reuse content