ARTICLE IN BRIEF:
Reports of undisclosed conflicts of interest among executives at a leading cancer center has prompted discussion among neurology department chairs about policies they have put in place to ensure transparency at their institutions.
Last September, Jose Baselga, MD, the chief medical officer of Memorial Sloan-Kettering Cancer Center in New York, stepped down from his post after reporting in ProPublica and the New York Times revealed that he had failed to disclose relationships with industry in articles published in major journals like the Lancet and the New England Journal of Medicine. The companies ranged from large pharmaceutical companies like Roche and Bristol-Myers Squibb to smaller biotechs.
In January 2019, Memorial Sloan-Kettering told employees that its senior executives would no longer be permitted to sit on the board of external for-profit health or science-related companies. And it instituted a series of policies that would limit the ability of its top executives and researchers to profit from work done there.
Academic medical centers have been grappling with policies and concerns about conflicts of interest for quite some time, and Memorial Sloan-Kettering is not the first to generate headlines around the issue. Indeed, Neurology Today spoke with leaders at several neurology departments across the country to find out how their institutions manage conflict of interest disclosures and discuss what could be done better.
“One of the big things that the New York Times/ProPublica series has done is put the spotlight on an issue that doesn't seem to go away and seems to be frustratingly difficult to solve and get right. Ten years ago, the Institute of Medicine issued its report on the issue and made a series of pretty straightforward recommendations that somehow disappeared off into the ether and weren't really widely instituted or implemented,” said Kenneth L. Tyler, MD, FAAN, the Louise Baum Endowed Professor and chair of the department of neurology at the University of Colorado School of Medicine.
Models for Disclosure
Dr. Tyler and neurology chairs at other academic medical centers described their own institutional policies and procedures with regard to reporting potential conflicts of interest, all of which they assessed to be fairly robust and rigorous and all of which follow a similar model. That model includes an online conflict of interest disclosure system, in which all faculty members must report all of their qualifying activity and/or engagements at least annually. In addition, any financial relationships that meet a certain institution-specific threshold deemed significant require a conflict of interest management plan, dictated and supervised by an institutional conflict of interest management committee.
At the University of New Mexico School of Medicine, for example, “A researcher may be required to only enroll patients in a study, but not to analyze the data or have any influence in the output portion,” said Corey Ford, MD, PhD, professor of neurology and senior associate dean for research at the University of New Mexico School of Medicine. “Occasionally we'll say, ‘You can't do both. Give up the study and research, or the relationship with outside interests, there is no in-between.’”
These are the main common factors, although different institutions may have some variations on the theme. For example, at the University of Colorado, almost all outside activities must be channeled through the physician practice plan, CU Medicine.
“They review copies of all contracts to make sure everything is above board. They also do the billing and collecting, with a series of rules for how income is disseminated back to the individual,” said Dr. Tyler. “Pretty much any activity that involves, for example, expert consulting for pharmaceutical companies would have to be rerouted through the practice plan. But even when an activity is routed through the practice plan, you still need to file it in the online conflict of interest disclosure system.”
The University of Colorado also has a separate set of requirements for participating in speaker's bureaus, with a committee that stringently reviews that specific category as well. “For example, you must have full and complete control over the slide deck, and not be provided a set of slides by a pharmaceutical company. They also review the compensation so that it's not excessive,” Dr. Tyler said.
At the University of New Mexico, Dr. Ford said, everyone who engages in research is required to do conflict of interest training every four years. “Many people do have a management plan because they have ongoing outside activities, so we have a separate management conflict of interest committee that meets twice a year to review each faculty member's plan to ensure that they are being followed,” he explained.
“We also have an institutional conflict of interest committee for senior officials above a certain level, designed to scrutinize things like major gifts from donors and industry sources. And outside collaborators who work on programmatic, multi-institutional grants based at UNM Health Sciences need to complete a disclosure form for us as well.”
The Neurology Factor
Neurology has many opportunities for relationships that create conflicts of interest, along with its rewards and risks, said Robert Holloway, MD, MPH, FAAN, professor and Edward A. and Alma Vollertsen Rykenboer Chair of the department of neurology at the University of Rochester School of Medicine and Dentistry. “Neurology has always been one of the specialties that has had a high number of consulting arrangements, whether it be with pharmaceutical or biotechnology companies or others. Our therapeutic landscape is just booming, so the potential for conflicts in terms of personal and research sponsorship is only going to increase. We need to remain forever vigilant and make sure we don't take anything for granted.”
After the latest news from Memorial Sloan-Kettering in January, Dr. Holloway spoke at a recent neurology faculty meeting and distributed a summary of key take-home messages about good disclosure practices. Among them, he suggested that faculty:
- Periodically check the Open Payments database even if they don't have outside financial interests and compare with their own records. During the appeals period, challenge incorrect information, he suggested.
- Draft disclosures for publications and presentations carefully. Interpretation of what may be “related” is likely to be broad.
- Include research sponsors as well as personal financial interests.
- Develop a standard disclosure statement for all publications.
“We all have curriculum vitae that we keep current. I recommend that faculty also prepare a ‘disclosure vitae’ for all possible relevant outside sources of income, including not just your personal financial interests such as consulting, but also all our research sponsors as well,” Dr. Holloway said. “Maintain a broad, inclusive disclosure vitae and be consistent in how you include it in publications and presentations.”
Room for Improvement
Despite the programs currently in place, the neurology chairs agreed that the system still needs improving. “I think this is a pretty ubiquitous problem in academic medicine and science,” Dr. Tyler said. “It reveals that mechanisms currently in place to safeguard against this don't really seem to be adequate or effective. This is certainly true if one says that the goal is to have full and complete disclosures of potentially relevant conflicts of interest that a reader of a journal or the equivalent should have, in order to be able to understand if there's any potential role that bias—either advertent or inadvertent—might play in the way results or other things are prepared.”
“The impact of the revelations about Memorial Sloan-Kettering is maybe a little bit of a wake-up call for everybody that this isn't a trivial matter and a reminder to all of us in academics, especially those affiliated with journals, that it is an imperfect system,” said Dr. Holloway.
At the Dell Medical School at the University of Texas at Austin, Dean S. Claiborne Johnston, MD, PhD, vice president for medical affairs and Frank and Charmaine Denius Distinguished Dean's Chair, said that the institution acknowledges the reality of the need for relationships between academia and industry.
“The reality is that in a protected, ivory tower academic environment, we're less able to disseminate the things we work on,” Dr. Johnston said. “Companies bring skills, technologies, scale, and capital that are really complementary to what we can do in academia. We purposely are trying to work with other companies, in partnership, and make sure that our ideas from here are translated out. When we function better together, the public wins. But we don't want individuals in our organization playing that system for personal gain.”
Dr. Johnston said that his medical school currently uses the existing UT electronic disclosure system, which is similar to those described at other institutions. “But it's not public-facing, so we're looking for another system, ideally cloud-based.”
The current system at most institutions encourages sloppiness, he added. “I'm working on a manuscript right now. It's a lot of hard work. You're formatting, you're rewriting, the figures aren't right, you're fixing the tables. The last thing you do is get all the disclosures ready, collect them from the investigators and put your own in there. You're kind of in a hurry, it's the last thing you do before submitting, and people are often sloppy. We need a system that works better.”
Dr. Holloway suggested that a central repository or common application for disclosures to journals, like the Convey Global Disclosure System launched in 2016 by the Association of American Medical Colleges, could significantly improve the process if it became commonly used, reducing the paperwork burden associated with disclosure, ensuring consistency, reducing errors, and providing easy access to records.
Dr. Johnston agrees, and thinks the approach should be even broader. “I think there should be one exhaustive source of information on faculty relationships and conflicts that is not specific to a single article. It should be reliably maintained and checked against Sunshine Act reporting, and available not only to journal editors, people who make guidelines committee selections and so on, but also linked to our faculty information page that is publicly available to patients.”
“We have a tremendous vested interest in ensuring that the science that is peer-reviewed and published is absolutely as honest and accurate and forthright as it can be, and there is plenty of room for this process to be better,” said Dr. Holloway.
Dr. Tyler has served on the data safety monitoring board for DNAtrix Inc. for NCT02798406, has received a consulting fee from Taiga Biotechnologies (Aurora, CO) and a research grant for studies on an immunomodulatory peptide in CNS infectious disease models. Dr. Holloway was a consultant to MCG Health and received consulting fees for reviewing their neurology guidelines. Drs. Johnston and Ford had no relevant disclosures.
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