By: Janet Woodcock, M.D.
This week the FDA will convene two advisory committees to discuss the results a readjudication, or independent review, of the results of a large, long-term study on whether patients are at greater risk of heart attack or death when taking the diabetes drug Avandia (rosiglitazone).
The fact that FDA is holding the joint meeting has been the subject of some controversy, even criticism aimed at the agency. Some question why we’re having the meeting at all, while others eagerly await the results.
Given the public interest in Avandia, the extensive history of the product, and the continued uncertainty of the risk surrounding this drug, FDA is holding this meeting to have a transparent, public discussion with experts across multiple scientific disciplines on the results of the readjudication of the study.
When the drug’s sponsor, GlaxoSmithKline, released the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial in 2010, it said it could find no potential elevated risk of heart attack or death in patients who took Avandia.
But some members of a previous FDA advisory committee, outside experts and even some experts within FDA criticized the trial and pointed to other evidence that raised questions about Avandia’s safety. So in September 2010 FDA requested an independent review of the study.
As I stated in 2010 when I requested the additional analysis, considering the time and effort spent by thousands of volunteers who participated in RECORD, I believe every effort should be made to learn as much as possible from its results.
The uncertainty about the risk of Avandia is overwhelmingly the most important reason for the differing opinions on the regulatory actions that have been taken on this medication. Therefore, we have an obligation to better understand the trade-offs based on as much scientific evidence as possible.
FDA will consider the recommendations of the advisory committees and the public input in determining if the results of the readjudication in the context of all the relevant available data affect the agency’s assessment of the risks and benefits of Avandia.
There have been, and continue to be, differences of opinion and scientific disputes, which is not uncommon within the agency, stemming from varied conclusions about the existing data, not only with Avandia, but with other FDA-regulated products.
At FDA, we actively encourage and welcome robust scientific debate on the complex matters we deal with — as such a transparent approach ensures the scientific input we need, enriches the discussions, and enhances our decision-making.
Since 2008, FDA has undertaken a series of organizational and management actions to help ensure that all scientific viewpoints are freely expressed, understood, and brought into the drug safety decision-making process, and significant safety issues are managed by multidisciplinary teams that include representatives from the Office of New Drugs, the Office of Surveillance and Epidemiology and all other relevant offices within FDA’s Center for Drug Evaluation and Research. This initiative, known as Equal Voice, emphasizes the basic values of speaking up, listening to and respecting the viewpoints of others in every professional interaction. It is intended to ensure that final decisions are made after all appropriate expertise is brought to bear.
CDER staff who don’t support agency decisions can raise their concerns with senior center leadership. This process may be used to address disputes among medical and scientific disciplines within the center as well as a dispute raised by an individual staffer.
Ultimately, the decisions we make directly affect public health, and we must learn as much as possible and use the information we have to responsibly inform our decisions.
Janet Woodcock, M.D. is the Director of FDA’s Center for Drug Evaluation and Research