On 2016 Dec 22, Vinay Prasad commented:

The reader has invented the idea that we believe some participants should be excluded from the ODAC meeting. We do not say that in the manuscript.

Yet, because a sizable percentage of speakers have financial conflicts with the Industry, one may question the representativeness of the public comment.

On 2016 Apr 06, John Tucker commented:

The article evaluates public commentators at ODAC meetings according to several characteristics that the authors believe are suggestive of conflict of interest.

• Having the cancer for which the drug is being evaluated
• Having received the drug in question
• Representing an organization
• Having been a principle investigator in the drug trials
• Or having a financial relationship with the sponsor, directly or by being a member or an organization that receives funding from the sponsor.

Overall, the authors appear to have misunderstood the purpose of the open comment period at FDA Advisory Committee meetings, which per the relevant guidance document, is to permit "participation from all public stakeholders in [the FDA's] decision-making processes".

Should having cancer, having benefited (or been harmed by) the drug under consideration be cause to exclude a speaker from presenting their view? Should being a member of an advocacy group related to the disease in question?

Of course not. Hearing from a diverse group of stakeholders is exactly the purpose of the Open Public Hearing of ODAC meetings. The search for conflicts of interest has its place, but when it is used to exclude patients and disease advocates from having input into the process, the ivory tower has become too fortified.

Having cancer is not a conflict-of-interest that demands that one's POV be excluded from ODAC meetings.

On 2016 Apr 06, John Tucker commented:

The article evaluates public commentators at ODAC meetings according to several characteristics that the authors believe are suggestive of conflict of interest.

• Having the cancer for which the drug is being evaluated
• Having received the drug in question
• Representing an organization
• Having been a principle investigator in the drug trials
• Or having a financial relationship with the sponsor, directly or by being a member or an organization that receives funding from the sponsor.

Overall, the authors appear to have misunderstood the purpose of the open comment period at FDA Advisory Committee meetings, which per the relevant guidance document, is to permit "participation from all public stakeholders in [the FDA's] decision-making processes".

Should having cancer, having benefited (or been harmed by) the drug under consideration be cause to exclude a speaker from presenting their view? Should being a member of an advocacy group related to the disease in question?

Of course not. Hearing from a diverse group of stakeholders is exactly the purpose of the Open Public Hearing of ODAC meetings. The search for conflicts of interest has its place, but when it is used to exclude patients and disease advocates from having input into the process, the ivory tower has become too fortified.

Having cancer is not a conflict-of-interest that demands that one's POV be excluded from ODAC meetings.

On 2016 Dec 22, Vinay Prasad commented:

The reader has invented the idea that we believe some participants should be excluded from the ODAC meeting. We do not say that in the manuscript.

Yet, because a sizable percentage of speakers have financial conflicts with the Industry, one may question the representativeness of the public comment.