Changes to Conflicts Policy Heighten Transparency

Following more than a year of rigorous discussion and deliberation, the Harvard University Faculty of Medicine Committee on Conflicts of Interest and Commitment has presented Dean Jeffrey Flier with a series of recommendations to revise and clarify the existing Policy on Conflicts of Interest and Commitment (COI policy). Dean Flier, who convened the committee in January 2009, has carefully reviewed and accepted the committee’s recommendations, which will be formally incorporated into the HMS COI policy over the course of the coming year.

The HMS committee served as a subcommittee to a larger University-wide group led by David Korn, Harvard’s vice provost for research. The University-wide group has simultaneously released a set of principles intended to guide the policies of all Harvard schools.

“Harvard Medical School’s newly revised financial conflicts-of-interest policy streamlines and strengthens what has been a longstanding concern with this issue,” said Steven Hyman, provost of Harvard University. “Its policy not only meets the requirements of Harvard’s new University policy on financial conflicts of interest, but also exceeds them in many key areas. Dean Flier and his committee have set a terrific example for the rest of Harvard’s schools to consider as they craft their own implementations of the University policy.”

“At HMS, we have a proud history of unwavering commitment to high professional standards of ethical conduct,” said Dean Flier. “Within and outside industry, many recognize that industry and academia must seek a new model of academia–industry collaboration to achieve greater success at discovery and development of new treatments while fully protecting academic values and those of the medical profession. It is incumbent upon us to create a culture that is open to creative new approaches to collaboration on scientific development, based on transparency, rather than one that makes novel interactions more difficult.”

First approved in 1990, the HMS COI policy has guided faculty interactions with industry for more than two decades. The HMS policy, which preceded federal regulations, was principally designed to address individual conflicts arising in research. Through the years, the policy has been periodically updated and amended. Dean Flier asked the present faculty review committee to reevaluate the policy’s scope and content in light of the increasing complexities of industry and academic collaborations.

The review committee, comprising 34 faculty members, senior administrators and students, met more than 30 times to consider both the existing policy and numerous topics not previously covered by the policy. The subcommittees looked primarily at education, research and compliance.

The committee’s recommendations, as accepted by Dean Flier, reflect a careful consideration of how the policy can better guide faculty members in structuring appropriate industry relationships. While reaffirming the undisputed benefits of academic–industrial collaboration for translating basic laboratory discoveries into therapies benefiting patients, the recommendations emphasize transparency and the reduction of marketing influence.

The recommendations accepted by Dean Flier include, but are not limited to, the following:

• Streamlining the existing HMS COI policy and disclosure form and process and developing a central reporting system that streamlines HMS COI disclosures with other required disclosures from affiliated teaching hospitals and institutions in which many faculty members have joint appointments. This will result in one uniform and far more accessible, easy-to-understand reporting system.
• Developing an education and disclosure monitoring system to assist faculty with understanding the new policy and disclosure requirements.
• Publicly disclosing all relevant faculty financial interests on the HMS Catalyst Profiles website.
• Prohibiting all personal gifts, travel and meals from industry, other than travel and meals in the course of allowed activities. This is consistent with requirements of Massachusetts law and guidance issued by the pharmaceutical and medical device manufacturer trade organizations PhRMA and AdvaMed.
• Prohibiting faculty participation in industry speakers bureaus. Further, faculty will not be able to accept compensation for a speaking engagement that limits the faculty member’s intellectual independence in presenting content.
• Continuing to develop and implement curricula about critical decision-making throughout the educational trajectory and training of students, trainees and faculty, while continuing to restrict access to the HMS and HSDM campus by sales and marketing representatives from pharmaceutical and medical device companies.
• Reinforcing standards of the Accreditation Council for Continuing Medical Education (ACCME) that ensure academic independence in the creation and delivery of Continuing Medical Education (CME) course content and limit industry funding of CME so that no one sponsor can fund a course. In no event will any single sponsor be able to support more than 50 percent of a particular course’s budget. HMS will establish a dean’s fund to allow for industry donation to be used at the sole discretion of HMS and HSDM.
• Restricting industry advertising and exhibitions at CME events, ensuring that industry programs and exhibits are marketed separately from Harvard programs.
• Reviewing and assessing any faculty member’s proposed participation on the fiduciary board of a for-profit biomedical business. The Standing Committee on Conflicts of Interest and Commitment will evaluate whether the arrangement gives rise to actual or potential conflicts of interest and may make recommendations to the dean.

The recommendations also reinforce the research restrictions that have been in place for many years, such as:

• Limiting sponsorship of a research project, regardless of the type of research, by a business in which a faculty member holds equity. The prohibition is absolute if the business is privately held. If the business is publicly traded, then a faculty member’s financial interest in the company cannot exceed $30,000.
• Prohibiting clinical research on a technology owned by or licensed to a business from which the faculty member receives more than $10,000 in annual income (down from $20,000).
• Reconfirming the already existing restrictions upon guest and ghost authorship.

These recommended policy revisions and restrictions will be put into effect and practice on a rolling basis starting in January 2011. The HMS Integrity in Academic Medicine website will have regular updates as the Office for Professional Standards and Integrity works to implement the committee’s recommendations to reinforce HMS’s longstanding commitment to integrity in science. It also includes an array of related resources.

“We are confident that these recommendations are consistent with the mission of the Faculty of Medicine and represent a balanced approach to a challenging and complex set of issues,” said Robert Mayer, committee co-chair and chair of the Standing Committee on Conflicts of Interest, who is also the Stephen B. Kay family professor of medicine at HMS and Dana-Farber Cancer Institute. “HMS faculty are committed to the highest ethical standards in research, patient care and the education of current and future healthcare providers, and we believe that these policy revisions will guide them as they fulfill their commitment.”

The other co-chairs of the Committee on Conflicts of Interest and Commitment are Joseph Loscalzo, the Hersey professor of the theory and practice of physic at HMS and Brigham and Women’s Hospital; Thomas Michel, HMS professor of medicine at BWH; and Christopher T. Walsh, the Hamilton Kuhn professor of biological chemistry and molecular pharmacology at HMS.

“We are pleased that the very rigorous Partners policies were a valuable guide, and we look forward to working with HMS throughout the implementation process’”—Gary Gottlieb, President and CEO, Partners HealthCare

“I commend Dean Flier and the Harvard University Faculty of Medicine Committee for their ongoing commitment to ensuring responsible collaborations with industry. The new conflicts-of-interest policy recommendations are very much in keeping with the policies in place at Brigham and Women’s Hospital and Partners HealthCare. This new policy will help provide clarity to our faculty, as many are subject to both Harvard Medical School and Partners regulations.”—Elizabeth G. Nabel, President, Brigham and Women’s Hospital

“Well-managed and appropriate interactions between academic medicine and industry are important for advancing biomedical research and improving care for patients. The revised conflicts-of-interest policy at Harvard Medical School, similar to the policy that we adopted last year at Partners HealthCare, strengthens and clarifies the processes that ensure the integrity of these collaborations and ultimately help preserve the public trust in our institutions.’”—Peter L. Slavin, President, Massachusetts General Hospital