Interview with FDA Panelist

Dr. Sanjay Kaul Discusses Diabetes, Obesity, and the Benefit-Risk Assessment for Drug Development

By: Vincent Wu, Sanjay Trehan, Joseph Shivers, and Kelly L. Close

We recently had the privilege of speaking with Dr. Sanjay Kaul, a noted cardiologist at Cedar-Sinai Medical Center's Heart Institute in Los Angeles and a cardiology expert who is often called on to advise the FDA's Endocrine and Metabolic Advisory Committee. In the past year, Dr. Kaul has played a highly influential role in the panel discussions on numerous diabetes and obesity medications, including Avandia, Qnexa, Meridia, Lorqess, and Contrave. Dr. Kaul also serves as a member of the FDA's Cardiorenal Advisory Committee, a role he has held for many years.

During our discussion, Dr. Kaul emphasized that the FDA pays more attention to the discussions at advisory panel meetings than the votes themselves, helping to explain the seeming disconnect between some advisory panel votes and the FDA's subsequent decisions (e.g., Contrave). To reduce public confusion, he suggested that the FDA remove the voting process altogether from advisory panel meetings – we at diaTribe hope this does not happen since we like to see explicitly how each member of the panel is leaning. In addition, Dr. Kaul focused on the need to assess cardiovascular outcomes for diabetes and obesity drugs, given that surrogate markers (e.g., A1C and weight loss) do not necessarily translate to benefits for the heart; notably, he didn't believe long-term outcome trials should be recommended for all obesity drugs, but where there is a "signal" (i.e., a worry), there should be such trials. Overall, he was very positive on the need for more drug development in obesity, making us believe that representatives from companies and the government should talk more frequently about how to make better treatments available.

ADVISORY COMMITTEE MEETINGS

Kelly: Hello, Dr. Kaul. Thank you so much for joining us! This is really an honor for diaTribe to speak with you. To start off, can you tell us how would you like to see the advisory panel process to be improved?

Dr. Kaul: One area that would benefit from a change is the voting process. Although the current simultaneous electronic voting is an improvement over the old "going around the table" verbal voting process in the sense that it tends to eliminate potential biases introduced by "group think" or "herd mentality," it nevertheless has its own limitations. Quite often, the yes/no vote introduces an artificial dichotomy with a fine line separating the two. There are times when the vote fails to capture or accurately reflect the content of the panel discussions... I am sometimes struck by how the voting process is viewed as a contest between the absolute certainties of yes or no. It is anything but. Calls for caution, and the ifs and buts that mark the deliberations appear to de drowned out. Thankfully, the FDA pays greater attention to the discussions around the vote than the simple vote count. This might help explain why nearly one-third of the time the FDA rejects approvals despite a "yes" vote by the advisory panel. Thus, I don't think it is unreasonable to question the utility of the voting process. Perhaps, the FDA should consider eliminating it entirely, since our vote is not binding and our job is only to offer advice.

Kelly: We hope from a patient perspective they don't eliminate it because we like seeing how the different panelists vote to get a sense of their priorities! This is harder to do without a vote, but we very much see your point. Many have criticized advisory panel compositions because so few panelists have been involved in drug development itself; panel members, due to concerns about possible bias, tend to be those who have less experience developing drugs from a commercial perspective. While that does allay fears about bias, it raises the question about whether there is enough experience on advisory committees to properly advise on what companies can practically implement and not implement. I wonder if you could share with us your thoughts on this.

Dr. Kaul: While it is true that experts most intimately involved with obesity drug development are not represented in the advisory committee, the FDA has a difficult responsibility to limit the biases and the conflicts of interest of the advisory committee. These are not just limited to financial conflicts but also include intellectual biases and conflicts. In my experience, the best advice often comes from expert "consumers" rather than expert "generators" of information and evidence. Nonetheless, in my opinion, the FDA does a very good job in assembling a panel with a broad spectrum of expertise in drug development, evidence appraisal, benefit-risk assessment, clinical decision-making, and the regulatory approval process.

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Last Modified Date: April 23, 2013

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