Influential journal The Lancet has pinned its flag to the pole and, in an editorial issued this week, called for a “calmer and more considered approach” to the fiasco surrounding GlaxoSmithKline’s blockbuster diabetes therapy Avandia (rosiglitazone), which was spotlighted by the equally esteemed US publication the New England Journal of Medicine after a systematic trial review showed it being linked to cardiovascular events. In fact, the review showed the risk of heart attack was upped 43% for patients taking Avandia compared to controls, with the risk of death from heart attack increased 64%.
Certainly the NEJM paper conferred a sense of “urgency”, notes The Lancet, a feeling echoed by US consumer group Public Citizen, whose director of its Health Research Group, Sidney Wolfe, claimed that Avandia "should be, at best, a last-choice treatment for type 2 diabetes,” adding: "we strongly urge patients - as we have for almost two and a half years - not to use this drug.” GSK’s stock reacted accordingly, taking a dive on global markets as investors reacted with a sense of urgency over the threat to the UK pharmaceutical giant’s second best-selling drug, which had first-quarter sales of $384 million, up 24%.
Taking a more considered approach
But in the wake of this panic selling, analysts have started to take a more critical look at the data, expressing a degree of skepticism about the findings. Indeed, they point to two earlier studies DREAM and ADOPT – which between them enrolled 9,000 patients – and showed some small but not significant increases in cardiovascular events. US drug regulator, the Food and Drug Administration - which is currently undertaking its own meta-analysis of Avandia and is due to publish its findings shortly – did issue a safety alert but said it “has not confirmed the clinical significance of the reported increased risk in the context of other studies,” while GSK too refuted the study outcome, saying it “strongly disagrees with the conclusions reached in the NEJM article, which are based on incomplete evidence and a methodology that the author admits has significant limitations.”
And it seems that The Lancet is also taking a more conciliatory tone, noting that patients, physicians and the FDA should await the results of the RECORD study – which has been specifically designed to analyse the CV events potentially related to Avandia. “Until the results of RECORD are in, it would be premature to over-interpret a meta-analysis that the authors and NEJMeditorialists all acknowledge contains important weaknesses.” It warned against creating “unnecessary panic amongst patients.”
And GSK is remaining upbeat. Conceding that product sales could suffer in the fallout from the study, he told the firm’s annual general shareholder meeting that once the complete dataset is published (at a US advisory committee meeting pencilled in some time in the coming months), Avandia could be vindicated and see its revenues gain ground once again.