Perennials and hope spring eternal. And so it seems does the debate over conflict of interest in academia. The latest deliberations took place last week in the pages of two of the world’s most prestigious medical journals. Three former New England Journal of Medicine (NEJM) editors commented in a British Medical Journal article about a recent group of NEJM articles outlining changing perceptions of conflict of interest and suggesting that readers re-examine the way they view relationships between physician-scientists and industry as it relates to publishing. The pieces included a three-part series by Lisa Rosenbaum, MD, who received her fellowship training at Penn’s Perelman School of Medicine, and an editorial by NEJM’s editor-in-chief, Jeffrey Drazen, MD. The former NEJM editors called the series a dramatic backtracking of the journal’s long-held policy on maintaining a clear line between academic contributors and their industry ties.
Issues of conflict of interest in academia arise largely around financial ties between scientists or physicians and industry, such as pharmaceutical companies or medical device makers. Examples of these types of conflicts include when investigators hold patents on a compound for which they may receive compensation during the drug development process or royalties on sales following FDA approval, or when an investigator is paid as a consultant to a drug or device company or owns stock in a company for which they are also conducting research. Increasingly, these relationships are transparently disclosed – in journal publications, through publicly available databases published by pharmaceutical and device companies or academic institutions, and in presentations at medical meetings – but issues of the potential bias that can result from these arrangements are a perpetual topic of discussion in the biomedical research field, and in coverage by the media.
It was a coincidence that during the same week these debates were raging in the pages of scholarly publications, the Institute for Translational Medicine and Therapeutics (ITMAT) held a symposium entitled “Conflict of Interest and Scientific Discovery” to explore how policies governing this issue affect the process of scientific discovery, and other related topics.
Former Institute of Medicine (IOM) president Samuel Thier, MD, professor of Medicine and Health Care Policy at Harvard Medical School, summed up the thorny and complex issues discussed at the two-day seminar by likening conflict of interest (writ large) to a hardy perennial: “It keeps coming up and has the ability to survive.”
Their was one of the symposium speakers from many areas -- academia, venture capital, the pharmaceutical and biotech industries, government, private foundations, journal editors -- who shared their perspectives. Anne Cappola, MD, ScM, director of the Clinical and Translational Research Center and symposium co-organizer spoke about goals of the symposium: “We brought in panelists from diverse disciplines to start a conversation about how to manage conflict of interest. We don’t want to impede the process of translating scientific discoveries to new therapies for patients.”
Symposium co-organizer Garret FitzGerald, MD, FRS, ITMAT director, notes that the Penn symposium is only the second national meeting on conflict of interest, following a 2009 IOM forum on the topic. “The interested parties also include the public, who need such conflicts declared, but who also need to understand why it is in their interest that industry-university sectoral divides begin to fragment,” he adds.
To be sure, conflict of interest as a field of study is extremely broad. This includes topics ranging from disclosure of relevant financial and other relationships by researchers to journals to how personal experience might influence the direction of research. An especially salient theme during the meeting was the notion that the reward system for scientists boils down to kudos, cash or both.
Many meeting participants, in fact, agreed that non-cash rewards in academia may have greater influence on individuals in academics. “Fame with a paper in a one word journal may be more important to an academician than fortune,” remarked FitzGerald.
Offering the venture capitalist view, Brian Dovey, a partner with Domain Associates, also notes that cultural differences between academia and the business world can color relationships. For example, he says basic scientists are more keen to do incremental experiments versus a venture capitalist mindset of going for the "killer" experiments early on the research process.
Still, although the U.S. may be where the modern entrepreneurial spirit was forged, Guy Chisholm, MD, PhD, former director of the Innovation Management & Conflict of Interest Program, and emeritus professor of Cellular and Molecular Medicine at the Cleveland Clinic, says promotion and tenure rules sorely need to incorporate concrete marks of achievements dealing with innovation and commercialization.
There were more than a few participants who agreed, saying that some younger faculty mistakenly think that any relationship with industry is a step over to the “dark side” and could hurt their career advancement.
Patient groups were also represented and have become a true partner in translating biomedical discoveries into treatments. Margaret Anderson, executive director of Washington, DC-based think tank Faster Cures, wants researchers to “look to us -- nonprofit patient groups -- as allies.” She says that the bias groups like hers has is that, “we want to make sure discoveries don't sit on the shelf. We add to the ecosystem.”
How can patients be part of the research and discovery process? One example: Patient-advocate Emily Kramer-Golinkoff, a project manager at the Penn Social Media and Health Innovation Lab, has an aggressive, rare form of cystic fibrosis. She has what the Penn Orphan Disease Center director Jim Wilson, MD, PhD, also a symposium panelist, calls an “ultra rare” disease.
Emily and others have written about a growing interest in participatory research, in which patients and patient-led foundations like Emily’s Entourage and the Castleman Disease Collaborative Network, along with the Orphan Disease Center, are key drivers behind basic research on rare diseases. In their approach, patients and foundations proactively push the research agenda by engaging all stakeholders, including scientists, clinicians, pharma, biotech, and venture capital to foster a collaborative approach to research to fast-track clinical breakthroughs.
Throughout the symposium, the panelists returned to the need to ensure that no matter the financial ties between academia and industry, the motives and behavior of individual investigators must be focused, always, on the delivery of novel, effective, and safe treatments for patients.
These motives can sometimes diverge for a range of reasons. Examples could include scrutiny of physicians who perform procedures involving devices for which they receive royalties, taking shortcuts with data analysis or human subjects’ protection, or gunning for a drug to go into trials when it’s not ready. Among these, monetary considerations are the easiest to quantify. As mentioned by Bernard Lo, MD, president of the Greenwall Foundation, and professor of Medicine Emeritus and director of the Program in Medical Ethics Emeritus at the University of California, San Francisco, declarations of such conflict are necessary, but in themselves are insufficient to address the issue of bias – real or perceived.
Perhaps, as FitzGerald suggests, we should move away from the adversarial terminology of “conflict” and begin to consider how best we might foster a “confluence of interest.”