The Hematologist

March-April 2019, Volume 16, Issue 2

In the Interest of Transparency

Roy L. Silverstein, MD 2019 President, American Society of Hematology; Chair and Linda and John Mellowes Professor of Medicine
Medical College of Wisconsin, Milwaukee, WI

Published on: February 21, 2019

Recent high-profile stories in the lay press, including front page feature articles in the New York Times, have again placed the issue of conflicts of interest (COIs) in medical science, particularly malignant hematology drug development, in the public sphere. Obvious COIs are clear threats to the trust that patients, elected officials, and the general public place in the medical profession. We as hematologists have managed these obvious COIs reasonably well by placing strict restrictions on the roles that owners of intellectual property can have in the execution and reporting of clinical trials related to that property. More insidious is the threat to public and scientific community trust, engendered by the more subtle and difficult-to-define concepts of “potential” COI or “appearance” of COI. When leaders of our most prominent clinical cancer research centers serve as highly compensated members of pharmaceutical company boards, or when investigators leading clinical trials of agents owned by companies also serve as highly compensated members of speakers panels or scientific advisory boards for these companies, our well-deserved public trust risks erosion. The paradox, of course, is that the academic thought leaders invited to serve in these compensated roles may well be the most qualified individuals to provide company boards with sage advice that ultimately will serve our patients well. The challenge to our profession is thus to balance the risk to public trust with the benefit of providing our expertise to accelerate translational research; and the question we must confront is whether simply disclosing these relationships is sufficient to eliminate the potential COIs.

Every academic institution must develop its own approach to these issues, but ASH, as a professional society representing more than 17,000 scientists and clinicians, has led by example in this complex environment. We have rigorous, thoughtful, and transparent policies to manage potential COIs, whether they be financial, institutional, or personal. Every ASH volunteer is required to disclose potentially relevant financial interests, and every committee, study section, task force, working group, and editorial board has a COI officer who is charged with reviewing these disclosures and ensuring that potential conflicts are addressed. At all meetings of these groups, the COI officer reviews ASH COI policies as the first agenda item of the meeting, and members are instructed to participate in managing potential conflicts and to be diligent in paying attention to potential conflicts. Members in conflict recuse themselves from relevant discussions and decisions. These policies have special relevance to ongoing ASH efforts in developing evidence-based clinical practice guidelines. ASH has developed clear and transparent disclosure requirements for all scientific meetings and publications, as well as oversight processes to ensure that our policies are followed, including empowering session moderators at the ASH annual meeting to call out potential COIs not disclosed by presenters. Rarely, undisclosed conflicts are discovered after articles are published, and we have clear policies that allow ASH leaders to authorize our journal editors to retract abstracts and publications, based solely on violation of COI policies.

Managing COIs is an important and difficult challenge. Ethicists debate whether participation in the for-profit pharma marketplace by clinical investigators is manageable by disclosure and recusal. ASH policies support this approach, but we recognize that implicit biases rooted in personal relationships, life experiences, and professional networks color our thinking in ways that are much more difficult to manage. We are committed to keeping the COI issue front and center in all our activities and welcome input from our members on this topic.

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