GlaxoSmithKline (GSK) has released a 30-page white paper refuting that the recent U.S. Senate report on its diabetes drug Avandia failed “to present an accurate, balanced or complete view of the currently available information on Avandia (rosiglitazone).”
In the statement, the company said it “rejects any allegations of concealing safety information or acting inappropriately on behalf of patients.”
The pharmaceutical giant also said that the Senate report “repeatedly cites documents out of context; thereby, crafting a misleading narrative that fails to acknowledge that there is important, relevant safety information pertinent to the understanding of Avandia.”
In January, the Senate Committee on Finance released its report after a two-year investigation into what GSK knew about the cardiovascular risks associated with Avandia and what the company possibly did to hide those risks.
In February, the Senate committee sent a blistering letter to the FDA admonishing the agency for its failure to properly recognize the risks involved with the diabetes drug.
In its white paper, also released in February, GSK wrote that a “fair examination” of the records will show that it has been "diligent in its efforts to thoroughly study the safety and effectiveness of rosiglitazone, and to widely communicate that information to governments, regulatory authorities, scientific peers, physicians and others in a variety of ways.”
GSK cited its ongoing communication with the FDA regarding studies to determine risks associated with Avandia:
- “Preliminary results for this first meta-analysis, in 37 randomized clinical trials, were submitted to FDA in October 2005.”
- In May 2006, GSK submitted “a second expanded meta-analysis” that included an addition five clinical trials, bringing the total to 42 randomized clinical trials.
- “In June 2006, the results of a balanced cohort observational study examining a composite endpoint of hospitalizations for myocardial infarction and/or coronary revascularization comparing Avandia to other anti-diabetic agents became available.”
- In 2007, GSK met with the FDA “to present data on myocardial ischemic events and therapy with Avandia.”
Based on the data submitted to the FDA, an advisory committee of outside experts in 2007 voted 22-1 in favor of keeping Avandia available for patients, according to the statement.
GSK wrote that the Senate report failed to “mention multiple studies that all corroborate the ischemic cardiovascular safety of rosiglitazone.” GSK then goes into great detail about all the trials associated with the drug.
In the white paper, GSK attempted to discredit a 2007 meta-analysis in the New England Journal of Medicine by Steven E. Nissen, MD, chairman of the department of cardiovascular medicine at the Cleveland Clinic. The analysis found that treatment with rosiglitazone was associated with a significant increase in the risk of MI and with an increase in the risk of death from cardiovascular causes that was of borderline significance.
GSK wrote: “Nissen’s meta-analysis is a retrospective analysis of pooled data largely from short-term Avandia clinical trials primarily designed to assess endpoints other than the cardiovascular safety profile of Avandia. [T]he Nissen meta-analysis has received widespread criticism in the peer-reviewed scientific literature and has been contradicted by other, more robust, meta-analyses."
In conclusion, GSK wrote that it “respectfully disagrees with the Committee's decision to publish a Staff Report with such errors of fact, omission and inference.”