Boston Globe: Harvard will stiffen rules for staff at med school: COI

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Harvard will stiffen rules for staff at med school

Conflict of interest will be redefined

By Liz Kowalczyk, Boston Globe Staff | February 3, 2009

Harvard Medical School plans to strengthen its conflict-of-interest rules

for doctors and researchers, amid a US Senate investigation into several

faculty members and a new state law that will make public some of the payments

doctors receive from pharmaceutical and medical-device companies.

Many top medical schools, including Stanford University, the University of

Pennsylvania, the University of California at Los Angeles and at San

Francisco, and the University of Massachusetts have adopted stricter policies

in the

past two years. Last year, the American Medical Student Association graded

Harvard with an F on its conflict-of-interest policy because it does not

address

issues like whether companies can provide gifts and meals for faculty.

But Dr. Korn, Harvard University's vice provost for research and a

nationally known leader on conflict-of-interest policies, said Harvard's job is

considerably more challenging, because the medical school does not own or

control its affiliated teaching hospitals, where clinical faculty members see

patients and interact with drug company salespeople. And most clinical faculty

are employees of the hospitals, not the medical school.

" I personally would like to see the medical profession above public reproach

to the maximum extent possible, " said Korn, who was hired several months ago

and will oversee a review of all the university's conflict-of-interest

policies, including those at the medical school. He said the gifts doctors

receive

from drug companies " are unnecessary and distracting and in some ways

demeaning to the medical profession. " But the medical school " has to bring the

hospitals along with it, " he said.

Harvard's teaching hospitals, including Massachusetts General, Brigham and

Women's, and Beth Israel Deaconess Medical Center, each have their own

conflict-of-interest rules, which overlap with but are separate from those for

Harvard Medical School.

The medical school's policy focuses on limiting research conflicts; for

example, it bars faculty or their family members from holding more than $30,000

worth of stock in publicly traded companies, and any equity in privately held

companies that sponsor their research, or from receiving more than $20,000 a

year in consulting or other fees. The hospital policies generally cover

research conflicts but also set rules for whether drug companies can provide

meals

for doctors during educational talks and give them gifts. Doctors are

required to fill out various forms for the hospitals and medical school each

year,

disclosing many of their relationships with industry.

A 19-member committee will review the entire policy, which could take a

year, said the medical school dean, Dr. Flier. He said that the policy

is

revised regularly - most recently in 2004 - and that the current review was

not prompted by the Senate investigation or the new state law. US Senator

E. Grassley, a Republican from Iowa, has accused three Mass. General

psychiatrists of not fully disclosing payments they received from drug

companies

for consulting and other activities. The doctors have said they believed

they complied with the rules. Harvard Medical School and Mass. General are

conducting their own investigations.

" The public and regulatory agencies are saying we have to be much more

transparent about any relationships faculty have with industry, " said Dr.

Schwartzstein, a member of the review committee and a pulmonologist at Beth

Israel Deaconess. " The trend is to become more and more stringent, there's no

question about that. "

Flier said one area the committee probably will focus on is continuing

medical education. The medical school sponsors several hundred courses for

doctors

each year, Harvard officials said, and drug companies pay about 13 percent

of the cost. He said the medical school does not allow pharmaceutical

companies to influence the content of courses. But some medical schools have

adopted

additional safeguards against industry influencing education for physicians,

such as requiring companies to give money to a central office, which then

distributes it to pay for courses. Others are discussing banning industry

funding altogether.

" I don't think we need to go there, " Flier said, about entirely barring

company funding for education. " If you have the appropriate separation between

the source of funding and the speakers and the topics, it's not a problem in my

point of view. "

Harvard also is under pressure from some medical students demanding stricter

rules. Last year, a group of students pushed for and won a new policy

requiring lecturers, faculty members, and visiting professors to disclose any

financial interests they have in a company or treatment they discuss. Students

say

enforcement of the policy is spotty.

" We do see that interaction between industry and [doctors and hospitals] can

be very beneficial in providing new therapies, " said one of the students,

Kirsten Austad. " But when it's not above board it can create mistrust between

patients and doctors. "

Liz Kowalczyk can be reached at _kowalczyk@..._

(mailto:kowalczyk@...) .

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