Harvard Medical School Students Push to Codify Conflict of Interest Polices

In early September, the first-year Harvard Medical School students in a biochemistry class expected to learn about protein degradation. Instead, they came out of lecture ready to push for more comprehensive conflict of interest policies.

Addressing a weekly clinic for “The Molecular and Cellular Basis of Medicine,” a required introductory course for first-year medical and dental students, Medical School professor Paul G. G. Richardson was accompanied by a patient diagnosed with myeloma, a potentially deadly blood cancer.

The patient was being successfully treated with a bortezomib-based therapy, a drug marketed as Velcade by the Cambridge-based Millennium Pharmaceuticals. Students said that during the clinic discussion, Richardson suggested bortezomib can now be used as a first-line treatment—meaning that physicians can prescribe use of the drug at diagnosis, rather than only as a second or third-line therapy when the disease has recurred.

Intrigued by his presentation, several students later looked up some of his peer-reviewed articles and found that Richardson was on Millennium’s advisory board—a potential conflict of interest that was not disclosed during the session with Richardson and his patient.

Richardson, a physician and clinical researcher at the Harvard-affiliated Dana-Farber Cancer Institute, did not violate any existing policies. In an interview, he said that he did not disclose his ties to Millennium because he wanted to keep the discussion centered on the patient and because it would have been insensitive to bring up the tie with Millennium in front of him.

And, Richardson added, bortezomib was in fact approved by the U.S. Food and Drug Administration this June as a first-line treatment for myeloma.

Though Richardson did not violate any ethics policy, the students had touched on an important issue—up until then, the Medical School did not have a codified conflict of interest policy for the classroom. As several Medical School professors have recently come under fire for failure to disclose conflicts of interest, first-year students banded together to push for stronger disclosure policies at the school.

“It’s important for students to have access to unbiased information based on scientific evidence,” said David C. Tian, a first-year medical student who soon joined his peers in their quest to tighten the school’s conflict of interest policies.

In response to the student concerns, the school’s curriculum committee revised the school’s student handbook last month to include a section of new policies mandating that faculty and students disclose all financial ties to pharmaceutical companies when discussing drugs developed by those companies.

If Richardson were to give the same presentation on bortezomib today, he would be required to disclose his relationship with Millennium, though he said he would likely do this either on the syllabus or on the course Web site.

Additionally, the handbook now states that pharmaceutical company representatives are not allowed to interact with students on campus, and industry sponsorship of student events is prohibited. Both had been informal policies that had “been in effect for many years” before being officially codified, administrators said.

Gretchen A. Brodnicki, the dean for faculty and research integrity, said that updating the handbook last month provided an “opportunity to commit the policy to writing.”

In a letter to the community detailing the extensive revisions, Jules L. Dienstag, the dean for medical education, wrote that the handbook is a “‘living’ document, reflecting the rules that govern us and how they evolve.”

Despite the recent revisions to the handbook, students have complained that the administration’s response has been marred by a lack of transparency.

“I think that the student-administration cooperation on the [conflict of interest] issue to this point hasn’t been wonderful,” said Tian, who is also a member of the Harvard Chapter of the American Medical Student Association.

Shamsher S. Samra, a first-year medical student, said that students had been prodding the administration to revamp the Medical School’s conflict of interest policies for roughly six years to little effect.

“It’s almost as if we’re reinventing the wheel in terms of starting to engage the faculty and say, ‘We’re not happy with the existing policies, and we’re going to do something about it,’” Samra said.

The new disclosure policy, Samra said, attests to the students’ efforts and will hopefully prompt more policy changes at the Medical School.

Several students, including Tian and Samra, continue to push for stronger conflict of interest policies, especially those at Harvard’s 15 affiliated hospitals, where third- and fourth-year students start their clinical education.

Dienstag said in an e-mail to those students that “steering the new disclosure policy through took considerable effort,” and that he was “delighted” with the outcome.

Dienstag did not deny the importance of conflict of interest policies at the Medical School, but he reminded the students that tackling these issues and standardizing policies across the University will take time.

“[Your] impatience is palpable in your e-mail messages, and we wish we could settle all these important issues quickly,” Dienstag wrote, “but arriving at ultimate policies is a delicate enterprise, complicated in no small way by ongoing investigation, parallel efforts at the hospitals to address COI, and the University’s commitment to overseeing the process centrally.”

David Korn ’54, a former dean of Stanford University School of Medicine who will begin a term as Harvard’s first vice provost for research next week, will be leading the University-wide review of industry-related practices and policy that was scheduled for this fall.

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