Partners' Conflict of Interest Policy's Reach Concerns Docs

Harvard Medical School assistant professor Paul M. Copeland routinely gives about a dozen industry-sponsored talks each year, earning anywhere from $1,250 to $2,000 per gig.

Copeland, who heads the endocrinology division at Partners Healthcare-affiliate North Shore Medical Center, says he isn’t in it for the money.

These information sessions—or “talks for docs”—improve patient care, he says, and all the material he presents has been approved by the Food and Drug Administration.

But due to a new Partners policy announced last April, Copeland cannot register for the 2010 speaking cycle.

Partners Healthcare, which owns Harvard-affiliates Mass. General Hospital and Brigham and Women’s Hospital, recently overhauled its conflict of interest policy, which proponents hail as one of the strictest in the nation.

Under the revised policy, Partners employees face a host of restrictions, including bans on speaking at industry-sponsored events and receiving stock options from pharmaceutical companies. Outside pay for senior officials sitting on boards of drug or medical device-making companies has been capped as well.

Though many regard the new policy as a much-needed check on industry ties to medicine—an issue that has received heightened national scrutiny in recent years—some Partners employees caution that the new restrictions may be too broad and could ultimately stifle essential physician activity.

For example, continuing medical education talks sponsored by drug companies, Copeland argues, provide doctors with the latest information on treatments and address patient care issues.

“If the talks are well done, you educate physicians about the proper role of medications,” Copeland says, adding that he regularly fields an hour’s worth of questions from doctors who attend his talks about case studies and alternative treatments.

“Patients and doctors benefit from these talks,” Copeland says. “That’s why it’s so disheartening.”

LONG IN THE WORKS

In the fall of 2007, Partners Healthcare embarked on a conflict of interest review to better define the relationship between industry and medicine as well as strengthen oversight of physician activity with drug companies.

Conflict of interest issues gained national attention the following year, when Senator Charles E. Grassley, an Iowa Republican and the ranking member of the Senate Finance Committee, alleged that Mass. General psychiatrist Joseph Biederman received $1.6 million in consulting and speaking fees from the makers of drugs that he used to treat children for bipolar disorders.

As Grassley charged other prominent physicians across the nation with similar allegations, many medical institutions looked to revamp existing policies in the face of national scrutiny.

Harvard Medical School began a review of its own conflict of interest policy in Jan. 2009 in conjunction with Harvard’s currently ongoing efforts to develop University-wide recommendations and guidelines.

Medical School professor David B. Acker, who is also chief of obstetrics at Brigham and Women’s, says he approves of Partners’ new policy, which was released in April 2009 and is now being implemented.

“I can’t comment on how other people viewed this, but to me, it came late,” Acker says. “It has been an obvious problem for some time.”

WALKING THE LINE

But several other employees have raised concerns that its reach may have detrimental effects on physicians’ activities, such as continuing medical education.

Though Medical School professor Charles N. Serhan, who served on the committee that issued the policy recommendations, says he applauds the policy’s aims to rein in conflicts of interest issues, he cautions that its expansive reach does not come without costs.

“I feel that the pendulum is a little too far in one direction in that our rules are now too tight and could actually stifle innovation,” Serhan says. “With time, it has to come back to some equilibrium.”

Mass. General’s chief surgeon Andrew L. Warshaw acknowledges the necessity of Partners’ policy overhaul but says he is concerned that certain initiatives such as surgical fellowships, which are generally dependent on industry funding, may suffer from the crackdown on outside funding.

“Let’s say that you have a general surgeon who wants to learn minimally invasive techniques, a scenario that is commonly funded by outside interests,” he says. “Is that a bad thing? When someone gets training that they wouldn’t normally get and helps patients?”

Warshaw adds that maintaining the necessary relationship between industry and medicine without distorting physician incentives remains a challenge.

“Society has to make a decision about what skills or new knowledge it wants and values and how it will pay for them, “ he said. “This is the narrow line that we are trying to walk.”

NO MORE TALK

Meanwhile, Barry W. Levine, a clinical professor at the Medical School who has worked at Mass. General for four decades, says he is still figuring out how the new policy will impact his profession.

Levine spoke about lung disease on behalf of drug companies like AstraZeneca and GlaxoSmithKline for about 18 years but says he does not plan to take on any more speaking engagements until the implications of the policy become clearer.

Like Copeland, he says that the new regulations stymie critical education about asthma and emphysema for doctors in underprivileged communities. He routinely meets physicians who do not have access to pulmonary function machines, which are critical for diagnosing these diseases.

“I don’t know why Partners suddenly said this is promoting a drug,” Levine says. “It certainly doesn’t in my mind.”

Moreover, Levine says, the drug companies sponsoring the talks have no power to censor what materials physicians present, as long as the information has been approved by the FDA.

“The drug companies do not tell me what I can say,” he says. “I’ll say what I want.”

—Staff writer Barbara B. Depena Depena can be reached at barbara.b.depena@college.harvard.edu.

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