• Tuesday, February 14, 2012
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Minnesota Regents Outline Policy to Toughen Rules on Financial Conflicts of Interest

The Board of Regents of the University of Minnesota voted unanimously on Friday to approve a new policy that toughens the system's standards governing financial conflicts of interest in scientific research.

The regents acted after high-profile cases raised concerns about such conflicts. One such case was that of David W. Polly Jr., the university's chief of spinal surgery, who lobbied Congress in 2006 for $460,000 to study military combat injuries without revealing that he was paid $1.2-million by Medtronic Inc., whose products were part of the study.

Other examples include psychiatrists at the University of Minnesota who were found to have received consulting payments from drug makers and then recommended their medications for children without disclosing the payments to the parents.

The new rules are especially necessary now, as financial pressures on colleges and universities increase the likelihood of ethical shortcuts, said David M. Larson, a regent who has served as executive vice president at Cargill Inc., a food services company.

"Historically the incidents have gone up rather markedly" during depressed economic conditions, Mr. Larson said.

The implications of the new policy (see Page 59 of the regents' "Quarterly Report of Grant/Contract Activity") were not immediately clear, however. Despite two years of deliberations over the policy, its language consisted largely of an outline of expectations without specific rules and penalties.

It included general statements such as: "The university is committed to ensuring that relationships between its faculty and staff and business entities are transparent, grounded in objectivity and do not improperly influence covered individuals' professional judgment, exercise of university responsibilities, or performance of university-related activities."

The university's vice president and chief of staff, Kathryn F. Brown, told the regents that administrators will now begin filling in the details, which will include a higher standard of financial disclosure for those involved in "higher-risk activities," such as human-subject research.

Several regents said they accepted that approach, though one, John R. Frobenius, expressed concern. Mr. Frobenius, a retired hospital administrator who served as president of St. Cloud Hospital and co-president of the CentraCare Health System in St. Cloud, said he feared the requirements could prove unnecessarily complex and burdensome.

"We are moving into cutting-edge territory," he said. "This could be an enormous drag on the university."

About a third of university medical schools have approved new policies to limit conflicts of interest in research in the past two years or are planning changes, said Allan J. Coukell, director of the Pew Prescription Project.

The American Medical Student Association, in a joint project with the Pew Prescription Project to rate the quality of university financial-disclosure policies, gives the University of Minnesota relatively strong grades in most areas. It says, however, that the university has no policies regulating off-site educational events or the distribution of pharmaceutical samples, and lacks clear policies for oversight and sanctions.

Minnesota, at least to some degree, may be a victim of its own aggressive stance toward the problem. The New York Times published an analysis in 2007 that showed payments to Minnesota psychiatrists by drug companies rose more than sixfold, to $1.6-million, between 2000 and 2005, at the same time that prescriptions of antipsychotics for children in Minnesota's Medicaid program rose more than ninefold. The Times said it was helped by the fact that Minnesota was the only state that then required public reports of all drug-company marketing payments to doctors.

Minnesota, along with Massachusetts and Vermont, have been in the forefront of financial-disclosure policy, Mr. Coukell said. But many private companies, prodded by Congress, have already begun public disclosure of their payments to doctors, he said, and Congress is likely to require such disclosures nationwide as part of the health-care legislation that appears to be nearing final approval.

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