GlaxoSmithKline, in response to a staff report of the US Senate, said that the report draws conclusions on the safety of its diabetes drug Avandia on analyses not consistent with the rigorous scientific evidence supporting the safety of the drug.

In addition, the report cherry-picks information from documents, which mischaracterizes GlaxoSmithKline’s comprehensive efforts to research Avandia (rosiglitazone) and communicate those findings to regulators, physicians and patients, a statement said.

The safety and effectiveness of Avandia is well characterized in the label approved by the FDA, the GSK statement added.

Contrary to the assertions in the report, the scientific evidence simply does not establish that Avandia increases cardiovascular ischemic risk or causes myocardial ischemic events, the statement maintained.

In 2007, the FDA considered all the available scientific evidence on Avandia, including Dr David Graham’s assertions of elevated heart attack risk and demands that the product be withdrawn.

Based on the scientific evidence and a recommendation by an independent advisory committee of experts convened by the FDA, the agency has ruled that Avandia remain available to patients for the treatment of Type 2 diabetes, the statement pointed out.

In the years since the FDA addressed these questions about the cardiovascular safety of rosiglitazone, seven large, prospective, randomized, clinical trials have reported results.

None of these randomized clinical trials, which remain the gold standard for evaluating scientific and medical questions, show a statistically significant association between rosiglitazone and myocardial infarction (heart attack) or other ischemic cardiovascular events, the statement emphasised.

GSK has worked regulators to ensure that the Avandia product labeling is updated to add cardiovascular and other safety information as new data become available so that physicians can make the best treatment choices for their patients, the statement added. – TradeArabia News Service