GSK: NEJM article based on incomplete evidence

GlaxoSmithKline (GSK) has responded to claims published in the New England Journal of Medicine (NEJM) regarding adverse cardiovascular effects resulting from the administration of Avandia (rosiglitazone maleate), its treatment for type two diabetes.

The company rejects the conclusions of the article outright, reporting that it is based on a meta-analysis of studies that are lacking rigour and ill-equipped to provide definite conclusions regarding adverse effects suffered by patients.

GSK notes that different medical studies vary in size, patient types and endpoints, with the joint-analysis of data from these trials being a complex task resulting in potentially conflicting findings.

The firm reports that the journal article itself accepts its “fragility” and limitations, its authors stating that: “A few events either way might have changed the findings for myocardial infarction or for death from cardiovascular causes.”

“In this setting, the possibility that the findings were due to chance cannot be excluded.”

GSK reports that the sum of data from its large-scale Adopt, Dream and Record clinical trials indicate that Avandia has a comparable profile of adverse cardiovascular effects to other marketed orally-administered anti-diabetic pharmaceutical products.

This week, GSK also rejected claims made by the US senate committee on finance alleging that the firm had suppressed the independent assessment of clinical trial data relating to Avandia.