American Journal of Therapeutics 20, 591 (2013)
The Conflict of Interest Charade The recent controversy regarding a Chairperson of an FDA Advisory Committee talking at a conference raises “conflict of interest” allegations to a new level of absurdity. The controversy surrounds the Chairperson of the FDA Advisory Committee that deals with drugs that treat skin and eye conditions. The Chairperson was going to talk at a conference in Washington, DC where pharmaceutical company representatives pay to attend. The talk was directed to advise industry on how to avoid “mistakes she has seen first-hand that she wishes the sponsoring companies had avoided”. The lobbying group, Public Citizen, opposed the talk on the basis that it “raises concerns that the Advisory Committee member is approaching the work of the Committee from a pro-industry perspective”. This organization further demanded that “it is urgent that the FDA develop and articulate a written policy applicable to all Advisory Committee members to avoid a repetition of this type of shameful episode which could undermine, public confidence in FDA Advisory Committees and in the agency itself”. It is particularly appropriate to discuss this controversy in the American J Therapeutics, a publication whose mission is to disseminate knowledge in Therapeutics and to facilitate the development of new therapeutic modalities. This Journal as many other forums and individuals have striven to facilitate drug development, moving away from an adversarial model to one where industry, academia and the FDA work together to facilitate development for the purpose of improving medical therapeutics. It is absurd to object to a talk aimed at helping industry avoid pitfalls in the drug development process. The avoidance is not aimed at improving the “bottom line” of a company, but obtaining better studies, a better development program, so advisors to FDA and FDA itself can
1075–2765 Ó 2013 Lippincott Williams & Wilkins
determine the benefits and risk of a compound and then make an informed recommendation. When FDA meets with a company, whether it be for a Pre-IND meeting, a Pre- Phase II or Phase III meeting, Pre-NDA meeting, or to discuss a post approval study, the professionals at FDA are trying to guide the drug developers process to improve studies, their execution and presentation. These interactions have proven invaluable over the years and have provided meaningful improvements in the quality and type of data presented, facilitating drug and device development. Members of the FDA Advisory Panels also contribute to the process. The experience gained can greatly aid industry in proper study design, execution and presentation of informative data to an Advisory Committee. Should this knowledge be withheld because it “presents a conflict of interest”? Of course not, because there is no conflict of interest and even if one for the sake of argument could conceivably contrive a conflict of interest, the public good of providing the advice, open to all who want to listen, far exceeds any downside risk. Suggesting that a public discussion of research methods, data presentation methods and study design is “shameful” is both ludicrous and reprehensible. Let’s work to facilitate therapeutics, not hinder development. Let’s support industry FDA interactions. Let’s support Advisory Committee members advising industry in open forums on these matters. As long as trade secrets and confidentiality are maintained and an individual is not paid for advice and then must vote, advise or regulate on the matter, no conflict of interest occurs, either implied or apparent. John Somberg, MD Editor
www.americantherapeutics.com
The Conflict of Interest Charade The recent controversy regarding a Chairperson of an FDA Advisory Committee talking at a conference raises “conflict of interest” allegations to a new level of absurdity. The controversy surrounds the Chairperson of the FDA Advisory Committee that deals with drugs that treat skin and eye conditions. The Chairperson was going to talk at a conference in Washington, DC where pharmaceutical company representatives pay to attend. The talk was directed to advise industry on how to avoid “mistakes she has seen first-hand that she wishes the sponsoring companies had avoided”. The lobbying group, Public Citizen, opposed the talk on the basis that it “raises concerns that the Advisory Committee member is approaching the work of the Committee from a pro-industry perspective”. This organization further demanded that “it is urgent that the FDA develop and articulate a written policy applicable to all Advisory Committee members to avoid a repetition of this type of shameful episode which could undermine, public confidence in FDA Advisory Committees and in the agency itself”. It is particularly appropriate to discuss this controversy in the American J Therapeutics, a publication whose mission is to disseminate knowledge in Therapeutics and to facilitate the development of new therapeutic modalities. This Journal as many other forums and individuals have striven to facilitate drug development, moving away from an adversarial model to one where industry, academia and the FDA work together to facilitate development for the purpose of improving medical therapeutics. It is absurd to object to a talk aimed at helping industry avoid pitfalls in the drug development process. The avoidance is not aimed at improving the “bottom line” of a company, but obtaining better studies, a better development program, so advisors to FDA and FDA itself can
1075–2765 Ó 2013 Lippincott Williams & Wilkins
determine the benefits and risk of a compound and then make an informed recommendation. When FDA meets with a company, whether it be for a Pre-IND meeting, a Pre- Phase II or Phase III meeting, Pre-NDA meeting, or to discuss a post approval study, the professionals at FDA are trying to guide the drug developers process to improve studies, their execution and presentation. These interactions have proven invaluable over the years and have provided meaningful improvements in the quality and type of data presented, facilitating drug and device development. Members of the FDA Advisory Panels also contribute to the process. The experience gained can greatly aid industry in proper study design, execution and presentation of informative data to an Advisory Committee. Should this knowledge be withheld because it “presents a conflict of interest”? Of course not, because there is no conflict of interest and even if one for the sake of argument could conceivably contrive a conflict of interest, the public good of providing the advice, open to all who want to listen, far exceeds any downside risk. Suggesting that a public discussion of research methods, data presentation methods and study design is “shameful” is both ludicrous and reprehensible. Let’s work to facilitate therapeutics, not hinder development. Let’s support industry FDA interactions. Let’s support Advisory Committee members advising industry in open forums on these matters. As long as trade secrets and confidentiality are maintained and an individual is not paid for advice and then must vote, advise or regulate on the matter, no conflict of interest occurs, either implied or apparent. John Somberg, MD Editor
www.americantherapeutics.com
