February 25, 2010 (London, United Kingdom) — GlaxoSmithKline has launched a rebuttal to the critical report issued by the Committee on Finance of the US Senate that concluded there are risks associated with the use of rosiglitazone (Avandia, GlaxoSmithKline) [1].
The Senate report, recently covered by heartwire , had harsh words for GlaxoSmithKline, saying the company failed to disclose the cardiovascular risks to clinicians and patients, and in one of the accompanying documents, two Food and Drug Administration (FDA) officials suggest that rosiglitazone should be removed from the market, as have other experts contacted by heartwire .
In its 30-page "white-paper" response, GlaxoSmithKline states that it has been "proactive in investigating the safety data" of rosiglitazone and has kept all regulatory agencies, including the FDA, aware of its investigations.
The company is particularly critical of the emphasis the Senate report places on the conclusions reached by Dr Steven Nissen and Kathy Wolski (Cleveland Clinic, OH) in a 2007 meta-analysis that first questioned the cardiovascular safety profile of rosiglitazone. The company argues that this meta-analysis is "controversial," has been criticized by other researchers as having limitations, and has also been contradicted by other studies.
In addition, GlaxoSmithKline said the Senate report, while emphasizing the results of the Nissen meta-analysis, does not include discussion of the final results of ADOPT, DREAM, and RECORD. These studies were evaluated by the FDA advisory board in 2007 and led to a 22-1 vote in favor of keeping rosiglitazone on the market. ADOPT and DREAM were included in Nissen’s meta-analysis, however.
In response to allegations in the Senate report that it tried to silence researchers critical of the drug, GlaxoSmithKline says these incidents have been "mischaracterized" and were simply "efforts to ensure that information about the company's medicine was accurately presented by others." The company, it writes, "does not condone the silencing of critics, nor did it attempt to subvert the independence of scientific debate around Avandia."
In a statement issued in light of the Senate report, the FDA said that is currently reviewing data from RECORD on the possible cardiovascular risks [2]. Once the review is complete, full cardiovascular safety data will be presented at a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010.
"This work is ongoing, and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time," according to the FDA.
Heartwire from Medscape © 2010 Medscape, LLC
Cite this: GlaxoSmithKline Fires Back in Defense of Rosiglitazone - Medscape - Feb 25, 2010.
Comments