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The University of Minnesota Medical School is considering a new conflict-of-interest policy so strict that doctors wouldn't even be able to accept Post-it Notes bearing a drug company's logo.
The far-reaching policy, which if enacted would be among the toughest in the nation, comes as congressional investigators and the U.S. Justice Department are probing ties between doctors and drug companies and medical device manufacturers -- probes that have raised some difficult questions for the university.
The Medical School's proposed policy digs deep and reaches far into the entrenched relationship between the drug and medical device industries and the university's doctors, researchers and students, as well as the institution itself. If adopted, the policy would profoundly alter the relationship between industry and the state's largest medical school.
All personal gifts from industry would be banned. Free drug samples would be limited. Industry support for doctors' continuing medical education would be phased out. Doctors' consulting relationships would be disclosed to both patients and the public. Those financial ties would be monitored far more closely.
"It's really putting policies in place that would, as best as possible, ensure the patient's best interest,'' said Dr. Leo Furcht, co-chairman of the task force recommending the rules and chairman of the U's Department of Laboratory Medicine and Pathology.
A draft of the proposed policy was presented to Medical School Dean Deborah Powell last month and subsequently distributed to the school's faculty for comment. That process will likely wrap up by the end of the semester. It's unclear whether approval by the university's Board of Regents will be required. Either way, Furcht said the reaction so far has been mixed.
"Many people have said, 'This is something we have to do,' there are some who feel [the policy] has gone a little too far, and some who feel it isn't enough,'' he said.
Medical research component
Medical technology companies argue that doctor input is critical to making their products safe and effective. They also say physicians must be trained -- preferably by other doctors -- on the proper use of new devices. In addition, as government research funding languishes, industry often pays for the clinical studies for new drugs and devices. Without that support, many cutting-edge technologies might not be available for patients.
The university's effort comes at a time when similar ethics policies are under consideration at several other universities, including the University of Pittsburgh, Stanford University and the University of Pennsylvania.
Critics have long maintained that financial relationships between doctors and companies that make drugs and medical devices subtly, but effectively, sway medical decisions. A recent Star Tribune series documented those ties and raised questions about the way they could influence physicians.
"Even small gifts can influence behavior,'' said Dr. Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania's School of Medicine and a former faculty member at the U of M.
"The doctors who say, 'I can't be bought for a piece of pizza or a free box of doughnuts,' aren't paying attention to what empirical science shows influences people,'' he said. "It isn't just a drug company giving out $25,000 to give a talk and go on a nice vacation -- that would certainly influence you. But even if [a drug rep] shows up with a free lunch every week for 50 weeks, it tends to build a sense of reciprocity on the part of the people who get the free gift."
A question of money, ethics
The pharmaceutical industry spends as much as $57.5 billion a year promoting its products, according to a recent Canadian study, although only some of that goes for gifts and payments to physicians. It's not known how much medical device companies spend, but estimates run into the hundreds of millions.
The yearlong work of the university's task force comes at a time when these ties are being probed nationally by Congress and the Justice Department. A bill cosponsored by Sen. Amy Klobuchar, D-Minn, and supported by Sen. Norm Coleman, R-Minn., would require drug and device companies to publicly disclose payments to doctors.
Academia has not been immune from the controversy. Last week two prominent U.S. senators -- Chuck Grassley, a Republican from Iowa, and Herb Kohl, a Wisconsin Democrat -- sent a letter to the president of Columbia University in New York asking for details on the income from drug and medical device companies received by 22 doctors who conduct research at the Ivy League institution. Among them: Dr. Martin Leon, a principal investigator of two clinical trials involving a heart stent made by Fridley-based Medtronic Inc., and Dr. Gregg Stone, who has been lead investigator for studies involving a competing stent made by Boston Scientific Corp.
The senators also asked Columbia President Lee Bollinger to elaborate on funding the university received from five drug and medical device companies, including Medtronic and Boston Scientific, which employs more than 5,000 in the Twin Cities.
Also last week, a prominent Emory University psychiatrist, Dr. Charles Nemeroff, stepped down from government funded research studies at the university after he allegedly failed to reveal millions in drug company payments.
The U of M hasn't been exempt from questions over the issue. Last year, the New York Times reported on a case involving a 12-year-old girl who developed serious side effects after being prescribed an antipsychotic drug by a U psychiatrist in a way that was not approved by government regulators. The psychiatrist had received speaking payments from the drugmaker.
Also last year, Grassley launched an investigation into Medtronic's ties to doctors, including Dr. David Polly, who heads the U's Department of Orthopedic Surgery's Spine Service.
A work in progress
A policy adopted at the University of Pittsburgh is far more expansive than Minnesota's. It covers not only staff and students at the university's six schools of the health sciences, but employees in the university's medical system, which includes 20 hospitals and 500 outpatient sites in western Pennsylvania. The U's policy would cover 450 faculty members, 990 residents and fellows and 920 students at the Twin Cities and Duluth campuses.
Furcht said it will take time to unravel the university's pervasive ties with industry. "These are going to be living documents that will have to be fine-tuned as we move forward,'' he said.
Caplan said it's especially important for medical schools to exhibit high ethical standards. "When you teach, that adds an additional layer of obligation to be more objective,'' he said. "We're supposed to teach the next generation of doctors how to weigh the evidence independently and objectively."
Janet Moore • 612-673-7752
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