U overhauls Health Center ethics rules

After nearly three years of work, the University of Minnesota on Wednesday released new rules governing potential conflicts of interest between personnel in its medical school and business interests, including drug and medical device companies.

The ethics policy overhaul is part of a university-wide effort, but officials at the U say the new rules are far tougher for faculty and staff at the Academic Health Center, which includes the schools of Medicine, Dentistry, Nursing and colleges of Pharmacy and Veterinary Medicine. The policy for the health center took effect on Wednesday.

"The feeling was that the bar needed to be higher for people who come in clinical contact with patients and others," said Dr. Frank Cerra, the U's senior vice president for health sciences. "I think it's a good policy."

In recent years, controversy has surfaced at many of the nation's medical schools over what critics see as the pervasive and potentially inappropriate influence of drug and medical device companies on patient care and research. Conversely, businesses and many doctors argue that collaboration is essential to help advance medicine.

Cerra said the Academic Health Center's policy balances the interests of the two, including "disclosure, required oversight and guidance."

The U's medical school was the target of a congressional inquiry last year that largely centered on a $1.2 million consulting arrangement between spine surgeon Dr. David Polly and the Fridley-based medical device maker Medtronic Inc.

All of those covered by the Academic Health Center's new policy must report their financial interests to the university annually, as well as executive positions and board memberships. The dollar threshold for triggering a conflict-of-interest review by an internal committee is $5,000 at the Academic Health Center, compared with $10,000 for others at the university.

The U will also accept industry funding for continuing education events held on campus, but will retain control of the content.

In addition, covered individuals may give presentations at sales and marketing events sponsored by industry, but only if the information is "evidence-based" and representative of the person's "independent views."

The U policy largely bans industry from providing faculty and staff with meals and entertainment, as well as gifts, such as coffee mugs and pens that are often used as marketing tools by drug firms and others.

Further, covered individuals are barred from promoting products or services, and from accepting payment for recruiting patients for clinical studies, and for completing evaluations or surveys developed by businesses.

In addition, if a doctor has a financial interest in a drug or medical device company, he must provide written disclosure to patients if using the company's product. The same goes when writing in professional journals and professional public appearances.