Roundtable Takes on ‘Conflict of Interest’ Debate
Leaders in interventional cardiology prepare for increased scrutiny.
Representatives from academia, research, industry and regulatory agencies gathered Tuesday evening for a roundtable discussion on a controversial issue in health care: the potential impact of conflicts of interest.
With a specific focus on how such conflicts shape cardiology device development, the panel set out to offer insight into this hotly debated topic.
Moderator Richard L. Popp, MD, of Stanford University School of Medicine, opened the roundtable by remarking on the wide divergence of opinions surrounding this issue.
“There’s a broad spectrum of opinion about what to do when a physician has a relationship with industry that’s considered to be a potential conflict,” he said. “The spectrum goes from the idea that these can’t be allowed at all, that they’re inevitable for progress, or to the point where it’s manageable in nearly all situations.”
Managing conflict
For some, the primary question is not whether potential biases exist, but how to best handle them.
“The moment you ask yourself if you have a conflict of interest, you do, or you wouldn’t be asking that question,” said Martin B. Leon, MD, CRF founder and Professor of Medicine at Columbia University Medical Center.
Citing the AHA’s example of insisting that officers dissolve potentially problematic outside relationships, immediate past AHA president Alice K. Jacobs, MD, of the Boston University Medical Center, was similarly clear-cut in her advice. “Management, in my mind, is very simple,” she said. “Limit what you can do or sever your relationships.”
Management of these issues is much easier in Europe, where potential conflicts must be disclosed only by certain researchers, such as task force members recommending new guidelines, after which they are written in a log book to be viewed upon request, according to Michel E. Bertrand, MD, of the Hopital Cardiologique in France.
Donald S. Baim, MD, who recently moved from Brigham and Women’s Hospital to Boston Scientific Corporation, argued that potentially conflicted researchers should distance themselves from activities such as adjudicating data, compiling statistics and obtaining consent.
“We’re stuck with this issue forever going forward, and disclosure is not enough. We really need to be more creative about how we manage these conflicts,” he said.
As an example, Baim recommended having those with opposing views give their presentations within a short timeframe at meetings.
Annual meeting
TCT faculty member William W. O’Neill, MD, of the University of Miami, said that the organizers of TCT have taken past criticisms to heart when considering the design of the annual meeting.
“All TCT abstracts are selected by an adjudication committee involving 225 faculty supervised by the Society of Coronary Angiography and Intervention. We’ve been extremely aggressive to insist on faculty disclosures as best as we can. It’s not perfect, but we’re trying to be proactive, extending disclosures this year to include conflicts of faculty operators participating in live cases, which will be listed on screen,” said CRF Chairman Gregg W. Stone, MD.
“We’re trying to be ahead of the curve on this issue,” he added. “We were the first organization that I know of to insist that speakers who do not disclose their conflicts will not participate in the meeting. We also have an outside, independent panel which reviewed the entire TCT scientific program to ensure that it was free of commercial bias and conflicts of interest. We’re extremely sensitive to this and are trying hard to maintain both the independence and the scientific credibility of the meeting.”
Future scrutiny
While panel members were in agreement that egregious misdeeds were indeed rare, they also agreed that media attention and other factors will result in increased scrutiny in upcoming years.
“I represent industry, and my prediction based on my reading and interaction with our clients is that there’s probably going to be more disclosure, not less,” said Michael R. Callahan, JD, of the Chicago firm Katten Muchin Rosenman LLP.
According to Bram Zuckerman, MD, director of the division of cardiovascular devices for the FDA, there is an increasing need to build public trust, which will most likely translate into greater demands being placed on researchers.
“There’s a real issue here of scientific credibility that’s potentially getting in the way of a lot of significant device progress,” Zuckerman said. “But we also have to be realistic that most device trials are unblinded experiments, and the potential for introducing bias can occur in a variety of fashions. I think there’s a lot more that can be done to potentially improve clinical trials and science. The public really expects it at this time.”