Unfinished, but new ethics policy goes to regents

A sweeping conflict-of-interest policy that would apply to more than 18,000 University of Minnesota faculty and staff will get an important test before regents on Friday after more than two years of development.

The policy update comes after a handful of ethics cases embarrassed the university, including a university psychiatrist who published research on a drug made by a company he consulted for and a spinal surgeon who may have failed to disclose conflicts raised by his work for a medical device maker.

The university's general counsel, Mark Rotenberg, touted the revised policy for its flexibility and scope. It will cover nearly all university employees, not just those who work in health care or medical research.

It will also allow for stricter rules on some employees than others. For example, it could require some faculty to disclose every dollar of outside income - instead of just income above $10,000 - while giving others more leeway.

Rotenberg said the university is revising the policy to make sure it is "transparent, responsible and accountable" in its research and teaching.

The university is part of a national trend in approving a new conflict-of-interest policy, said Allan Coukell, director of the Pew Prescription Project, which tracks such policies in medicine. He said in the past two years, one-third of university medical schools have either approved new policies or are in the process of doing so.

"Within the leadership of the medical profession on the past several years there has been increasing concern over the both the reputation of the profession and the potential impact conflict of interest could have on patient care," he said.

Still, many details of the Minnesota plan remain to be worked out even after regents vote on the framework. The not-quite-finished policy doesn't set penalties for violations, nor does it specify which faculty must file the most detailed disclosures.

Rotenberg said the policy was crafted to protect the integrity of the university's work without discouraging the partnerships with business that turn its research into revenue.

The primary method for that is disclosure, he said. Once disclosed, some faculty will be able to maintain their business relationships through university-approved "conflict of interest management plans" that are intended to ensure the relationship doesn't improperly influence the employee's professional judgment.

The new Minnesota policy grew out of concerns in the medical school in 2008 that industry money might unduly influence patient care, scientific research and medical education. As the new policy has developed, the university has suffered some conflict-of-interest headaches.

A doctor working on the new ethics guidelines had himself been disciplined for steering a $500,000 grant to a company in which he had an interest. In another case, a university psychiatrist and consultant for drug maker AstraZeneca published research about a drug that was more positive than the company's own research.

And spinal surgeon David Polly was criticized last year by Sen. Charles Grassley, R-Iowa, for requesting funding for research on a Medtronic product without disclosing he had been paid more than $1 million in consulting fees by the company.

Rotenberg said the university's investigation into whether Polly violated the university's current conflict-of-interest policies is ongoing.

Bill Gleason, a professor in the university's department of medicinal chemistry and a frequent blogger on the issue, isn't impressed by the proposed policy.

"This is just a tiny step forward and we should have done more by now," he said.

He said the university should have put a new conflict-of-interest policy in place at the medical school, where the issue is most serious, long before trying to tackle the complexities of applying it systemwide.

"There's no excuse for the medical school to take this long to come up with a decent conflict-of-interest policy. None. Zero," he said.

Rotenberg said President Robert Bruininks decided the policy should cover all employees because problems can pop up anywhere. In a presentation to regents earlier, Rotenberg alluded to a 2008 case in which another university didn't know one of its admissions officers had a consulting business helping students get into college. He didn't name the university.

(Copyright 2010 by The Associated Press. All Rights Reserved.)

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