Medical School revises conflict of interest policy

Harvard Medical School (HMS) released a series of revisions to its conflict of interest (COI) policy today that strengthens its commitment to transparency and financial disclosure while recognizing the School’s commitment to industry collaboration.

Among many provisions, the new policy includes a streamlined central system for reporting faculty financial interests with industry; requires the public disclosure of certain faculty financial interests; bans faculty from accepting corporate gifts, including travel and meals; and ends faculty participation in industry speakers bureaus, making it one of the most stringent of any medical college in the country. In addition, faculty disclosures will be made available to the public on the Harvard Catalyst website.

“In all cases where financial interests are involved, an essential antidote to potential harm is transparency,” said HMS Dean Jeffrey S. Flier. “And so disclosure of relevant financial interests, both internally and for the first time publicly, will address this concern.”

Flier, the Caroline Shields Walker Professor of Medicine, said the updated policy is aimed at clarifying appropriate relationships between the School and its industry contacts. It will protect the interests of the public and maintain the integrity of Harvard’s faculty and institutions, he said, while providing clarity of expectations in collaboration between companies and Harvard faculty.

A comprehensive re-evaluation of the existing COI regulations has been a top priority for Flier since he was named dean in 2007, and the revised guidelines are the latest in a series of regular changes to a policy created in 1990.

In January 2009, Flier convened the Harvard University Faculty of Medicine Committee on Conflicts of Interest and Commitment. The 34-member panel includes HMS faculty, senior administrators, and students. His request to the group: Devise a new set of recommendations for the faculty policy, based on changes in the biomedical field and grounded in modern conventions and practices.

Ganesh Shankar — a medical student member of the committee — thought the new standards were an exciting reshaping of the “educational infrastructure” at HMS.

“Medicine is constantly changing,” he said, “and we recognize that education in medicine must be equally dynamic.”

The committee’s recommendations, accepted by Flier, will be formally incorporated into the School’s COI policy starting in January.

The HMS group is a subcommittee of a University-wide body led by David Korn, Harvard’s vice provost for research, which recently conducted its own rigorous review of Harvard’s COI policies and principles.

Previous HMS policy had regulated faculty interactions with industry for more than 20 years. The new guidelines include:

• A streamlined central system for reporting
  faculty financial interests with industry
• A public website for disclosure of certain
  faculty financial interests
• No
  personal gifts from industry, including
  travel and meals
• No faculty
  participation in industry speakers
  bureaus
• A further
  strengthening of existing limitations
  on faculty financial interests in companies that own or license
  technologies
  studied in clinical research
• New limitations on industry support for Continuing Medical Education
  (CME)
  courses
• New training for
  students and faculty on
  critical decision making regarding companies that make drugs or medical
  devices
• New review requirements on proposed faculty
  board memberships with for-profit companies.

Flier, a strong proponent of industry collaboration, has acknowledged that relationships between industry and academics involve an element of risk. “Some relationships,” he wrote in a white paper last year, “require scrutiny, analysis, institutional guidance, and, in specific cases, prohibition.”

However, even as he announced the new, more stringent guidelines, Flier wanted to make absolutely clear that the goal was not to create a wall between industry and medicine. “That would be precisely the wrong thing to do at a time when we want to promote and develop human health,” he said. “Doing that requires effective interactions between industry and academia of a kind that are judged to be appropriate.”

The central theme of the revised policy is transparency and increased disclosure of industry relationships, especially as related to ongoing research. They reinforce the restrictions already in place by:

• Prohibiting sponsorship of any research project
  by a business in which a faculty members 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
  a year.
• Prohibiting clinical research on a technology
  owned or licensed to a business with which the faculty member receives more
  that $10,000 in annual income. (The previous limit was $20,000.)
• Reporting of outside relationships with industry, including
  those relevant to ongoing faculty research, will continue to be part of a
  yearly disclosure process. And for the first time, Harvard will work
  with its
  16 affiliated hospitals and institutions to capture all required
  information
  through a common reporting mechanism for the approximately 12,000
  Harvard
  Medical School employees who work at the Medical School and its
  affiliated
  hospitals and institutions. Previously, each organization managed its
  own
  disclosure process.

Also for the first time, such financial disclosures will also be made publicly available on the HMS Catalyst website and will be part of a comprehensive institutional monitoring system. In certain instances, financial disclosures will also be subject to review by the HMS Standing Committee on Conflict of Interest.

The new disclosure mechanism, Flier said, will allow HMS to identify any potentially troubling trends and “areas where there might be a need for further policy revision.”

The new recommendations will also prohibit faculty participation in industry speakers bureaus if only industry presentations are used.

“It’s one of the biggest departures in the policy,” said Flier. “If you are Harvard Medical faculty, you can’t function as a member of a speakers bureau and give company-determined and prepared talks. It’s vital that our faculty maintain their intellectual control.”

The new guidelines also impact the small percentage of Harvard’s Continuing Medical Education courses that receive company funding.

Building on previous requirements, the new recommendations state that a course must be funded by more than one industry sponsor, with no one sponsor being able to support more than 50 percent of a particular course’s budget.

As part of the new policy, HMS will also develop a dean’s fund. It will solicit unrestricted industry donations to support Harvard’s Continuing Medical Education efforts, including research on best CME practices and technology-based teaching methods. “There will be no connection between the company and what we do with it,” said Flier.

He added that the fund “ties into the broader interest of how to use Harvard Medical School to have a positive influence in the world.”

Included in the new policy is a broad statement, in compliance with Massachusetts law, that prohibits the faculty from receiving industry-sponsored personal gifts of any kind. The new HMS gifts requirement will also extend to nonclinical faculty.

“Even if you are a Ph.D. scientist working on cells or mice you are subject to this policy,” said Flier. “We are now saying that this is part of our overall faculty policy.”

The updated HMS COI policy, said Korn, who heads the University’s efforts on COI policy, will further the School’s dedication to professional codes, institutional values, integrity, and transparency. It will also help HMS continue its efforts to enhance the future health of the country. “When all parties are clear on the rules governing potential relationships, and compliant with them, the hope is that more collaborations may be fostered and the significant educational, research, and health benefits captured for the benefit of the public.”

Under our new policy, we will limit potential abuses,” wrote Flier in an article appearing on the HMS website, “while promoting our great capacity to do good.”

Additional reporting
by Colleen Walsh