GSK hits back at senate committee over Avandia claims

GlaxoSmithKline (GSK) has issued a response to the US senate committee on finance regarding claims concerning anti-diabetic therapeutic Avandia (rosiglitazone maleate).

The firm has rejected accusations of attempts to suppress independent assessments of data relating to the compound and an attendant risk to patient health, reporting that its records show transparency on the part of the firm and full communication and cooperation with government bodies, scientists, doctors and the general public.

GSK reports that it has conducted extensive clinical trials of the compound in diabetes patients, including long-term trials specifically designed to assess the cardiovascular safety of the drug.

It adds that it has taken positive action on integrating and analysing its own clinical trial data while robustly monitoring unexpectedly reported adverse events.

“GSK has initiated the most comprehensive and rigorous program of scientific analysis for any oral anti-diabetic medicine on the market today, with experience in over 52,000 patients,” the firm states.

Furthermore, GSK notes that the analysis upon which the senate committee has based its claims is admitted by its author to be “limited”, with a supplementary editorial recording that the committee’s findings may be a result of chance.

In December 2006, GSK reported clinical trial data showing Avandia to be a more effective treatment for long-term blood sugar control in patients with type two diabetes when compared to glyburide and metformin.