Curbing Conflict

Harvard Medical School takes on conflict of interest

Over the past year, the Medical School has steadily become embroiled in the conflict of interest debate, as student groups lobby administrators to strengthen existing policies to regulate industry ties at both the school and at its affiliated hospitals.

The debate burst onto the national scene after U.S. Senator Charles E. Grassley, an Iowa Republican, reported last June that psychiatrist Joseph Biederman of Harvard-affiliated Mass. General Hospital received $1.6 million in consulting and speaking fees from the makers of drugs he had used to treat children for bipolar disorder.

Tensions mounted during the fall as a small group of vocal first-year students publicly challenged the Medical School administration with mixed success and divisive effect—even giving rise to a reactionary student movement put off by the first-years’ anti-industry rhetoric.

A year later, this fiery dialogue has cooled as the students wait for the release of recommendations from the Medical School’s 19-member conflict of interest review committee. In six weeks, the waiting ends, and the students will have to recalibrate their stances to a new reality.

RAISING CONSCIOUSNESS

After coming across what they viewed as a potential conflict of interest in a Medical School class last September, a group of first-year students banded together to press the administration to codify long-standing informal policies—effectively triggering the first set of conversations that would dominate interactions between the opposing student groups.

The first-years—members of the American Medical Students Association, a national group that has made waves by rating medical school conflict of interest policies—alleged that a board position held by Professor Paul G. G. Richardson raised concerns because a drug marketed by that company was discussed in class.

Richardson did not, in fact, violate any of the Medical School’s existing conflict of interest policies. But the AMSA students had touched upon an important matter—there was no written disclosure policy for the classroom at the time.

Spurred by the possible conflict and the lack of any written policy preventing it, the students began advocating not only for more stringent policies within the Medical School but also across the affiliated hospitals, where students complete their third and fourth years of training.

“This isn’t about a few bad apples,” says David C. Tian, a first-year medical student who joined the AMSA protesters early this year in their quest to revamp the school’s conflict of interest policies. “This is a systemic issue that requires policy-making on the institutional level. Harvard Medical School should represent the practice of medicine as a whole.”

A month after the movement began, the school’s curriculum committee revised the student handbook to include a section of new policies mandating that faculty and students disclose all financial ties to industry when discussing drugs developed by those companies.

But in pushing for a uniform set of policies that would apply to Harvard’s 17 affiliated hospitals and institutes, the students’ plans hit a snag that has plagued similar efforts for years.

Repeated attempts to adopt a uniform policy across the hospitals have fallen prey to the hospitals’ independence.

“Starting with our third year, our teachers are doctors who are interacting with industry on a daily basis in ways that the Medical School currently doesn’t standardize or set standards for,” Tian told The Crimson last fall.

But as administrators note, HMS—unlike many other medical schools—does not own or operate its affiliated hospitals. The hospitals are independent, non-profit entities, each under its own public charter and governed by its own board of trustees.

“We don’t want to step on the hospitals’ toes,” Gretchen A. Brodnicki, the school’s dean for faculty and research integrity, told The Crimson at the time. “But we can work with them and see what makes the best sense for them and the medical students.”

UNDER REVIEW

In November, Dean of the Medical School Jeffrey S. Flier held a town hall meeting for students that included discussions of current conflict of interest policy. He told the students that the Medical School’s hands were tied and that new conflict of interest policy would be left up to a larger University review.

“We heard that the Medical School could not act independently,” Tian says.

But the students heard a different story a few days before winter break, when they met with David Korn ’54, the University’s recently-appointed vice provost for research, who would lead the University review.

Korn told the students that the University policy would not craft specific policies and that any new code of conduct would have to be created by the Medical School.

In mid-January, Flier hosted a panel on corporate interactions with academics, featuring several members of the faculty with industry ties, according to Tian.

Later that day, Flier announced the launch of an internal medical school review of conflict of interest policy, and the committee drafting the new regulations was to include students.

The three students on the committee were all upperclassmen with no discernible ties to the fall’s rallies or petitions.

Mark L. Zeidel, chair of the department of medicine at Beth Israel, says the conflict of interest committee has met several times, breaking into subcommittees to tackle policy pertaining to basic research, clinical work, and enforcement.

He says that in initial meetings, committee members have dissected current policies and recommendations from the American Association of Medical Colleges, Stanford, and Cleveland Clinic.

Systems Biology Professor Peter K. Sorger ’83 adds that he “suspects” the new medical school policy will “closely align” with a new policy from Partners HealthCare, which owns two of Harvard’s largest affiliated hospitals. Partners chartered stringent regulations in April, imposing a blanket ban on gifts and forbidding administrators from having stock options in companies for which they hold board membership.

A month earlier, a new Massachusetts state law imposed a ban on gifts and a public disclosure mandate for pharmaceutical company funding in excess of $50, which will go into effect July 1.

Zeidel says that contrary to media portrayals, Harvard has historically had one of the most stringent conflict of interest policies in the country, especially regarding access to stock options.

“We have lost faculty members in the past because we were more restrictive,” he says.

STUDENT TENSIONS

In the aftermath of the AMSA protests, a new student group emerged to ensure that the AMSA students did not dominate the increasingly charged conflict of interest dialogue.

Representatives of the Benjamin Rush Society have met twice with Flier in recent months, according to group co-leader Vijay Yanamadala ’07, after the fledgling group issued a petition calling for preservation of industry relations at the medical school.

Society co-leader Brian S. Fuchs ’04 says that in their meetings, Flier seemed to privately agree with the group’s sentiments.

According to Tian, AMSA students have enjoyed no such administrative access. “We haven’t met with any administrators about the conflict of interest policy,” Tian says.

The groups opposing philosophies have created a apparent divide among students on the issue.

“We don’t take the scientific progress that has been made over the past 60 years for granted,” says Fuchs.

Yanamadala says that professors should be trusted to form ethical relationships, and that disclosure and transparency will allow for complete “self-regulation.”

Though the Benjamin Rush Society and AMSA agree that more transparency is necessary, one major source of contention remains.

The current medical school policy forbids all industry interactions with first and second year students.

AMSA has lobbied to extend that blanket ban to third and fourth year students, who leave the Quadrangle classrooms for hospital-based clinical work.

Yanamadala says the Benjamin Rush Society strongly opposes the proposal.

“It would be pretty detrimental to overall learning process,” he says.

Zeidel says that the committee is attuned to this issue, but there remains the problem of enforcing any regulations at the hospitals, where students will be off campus and cannot be policed directly.

Zeidel says that by including students on the committee, the Medical School hopes that other students will be encouraged to follow these “voluntary offsite” regulations.

INTERNAL DEBATE

Whatever the outcome of its deliberations, the committee appears unlikely to follow AMSA’s prescriptions verbatim.

The national group has consistently delivered scathing conflict of interest grades for Harvard and many other top-tier medical schools, drawing criticism from many in academia.

Zeidel says that he doubts the relevance of Harvard’s recent F grade.

“If you can give a school an F on something, you get news,” he says. “I don’t think the ratings have anything to with reality.”

Flier has publicly questioned the AMSA rating as well—Harvard automatically failed because it did not submit its conflict of interest policy for review.

“As a result, the relevance of the AMSA grade is a matter for legitimate discussion,” Flier wrote in an e-mail to medical students March 6 after the conflict of interest policy garnered national media attention.

Fuchs says that skepticism of the AMSA group is growing on campus.

“AMSA students are louder and more obnoxious than any other student group,” says Fuchs. “You wouldn’t want to be using a pen provided by a drug company in their presence because you would be sure to get a response.”

Tian says he helped run a meeting after class this spring that sought to diffuse misconceptions about conflict of interest.

Zeidel adds that he does not think the Medical School was treated fairly during the student protests last fall. He says that the students did not give HMS the opportunity to address the issue internally before going public.

“I would have asked to sit down with the Dean of the Medical School and have a conversation,” he says. “I think its fair to say there are ways to get things done in a constructive manner that will get less publicity, but will actually get the job done.”

Though Zeidel says he has no ties to industry because he is setting an example for his department, he is still unsure that he espouses the views of some of the “more radical” members of the HMS faculty.

“If you disagree with them, that doesn’t mean that you are evil or somehow conflicted,” he says.

—Staff writer Laura G. Mirviss can be reached at lmirviss@fas.harvard.edu.

—Staff writer June Q. Wu can be reached at junewu@fas.harvard.edu.