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Conflict-of-Interest Policy Tightened and Clarified


Steven Lowenstein, MD

By Dan Meyers

 

(May 2012) A headline in The Denver Post was a reminder that health care providers, and the schools that teach or employ them, need to remain vigilant about conflict-of-interest issues.

The Post declared: “Docs limit drug-firm ties.” The ties refer to payments to doctors from pharmaceutical companies and medical-device manufacturers.

The smaller headline tells another important part of the news: “Payments must pass ethics muster ….”

The story underscores changes that have occurred recently at the University of Colorado School of Medicine. The school has had conflict-of-interest (COI) rules on the books for years.

But in 2011 those rules were both tightened and clarified—the “ethics muster.” The guiding principle is this: faculty cannot accept money to help a company market or promote a product.

The main target of the change was what are called “speakers bureaus.” Companies set these up to pay for speeches by physicians and others. CU now bans such participation.

“We’ve made explicit what always was our intention,” says Steven Lowenstein, MD, an emergency department doctor and associate dean who helped shape the new policy. “Our doctors can’t promote products. Drug companies can’t tell our doctors what to say or require them to use the companies’ slides or other instructional materials. And speaking requests will be reviewed by a new committee.

“The committee review is designed to separate truly educational talks and research-related talks, which are permitted, from talks that are about marketing and promotion.”

Lowenstein notes that research collaboration and research-related talks are allowed because they advance the science and practice of health care and benefit patients. For example, a doctor might have a contract with a pharmaceutical company to assist in developing, testing or assuring the safety of a new drug or device.

The issue of payments to physicians has gained prominence because of reporting by the organization ProPublica. In October 2010, they published a report called “Dollars for Docs,” based on pharmaceutical company payment disclosures that recently had become available.

A small number of CU faculty members were among those listed. Faculty members and Dean Richard Krugman began discussing how to tighten and toughen the conflict-of-interest policy.

“The status quo is no longer acceptable,” Krugman has said.

The latest stories were triggered by a second wave of disclosures in September from Pro- Publica, using data from several more companies (12 total). Payments totaled $760 million nationally since 2009, including those previously reported.

The medical school’s faculty leaders also have agreed to a recommendation from students to extend the conflict-of-interest disclosures to the classroom. That recommendation is contained in a revised Teacher-Learner Contract, which will encourage teachers to disclose their relevant financial ties and conflicts of interest to students during lectures, seminars and mentored research activities.

Meanwhile, the CU medical school adopted new rules that the Faculty Senate, Executive Committee and individual faculty members had discussed and refined over the previous months. Those rules went into effect June 1. The main points are:

  • Research consulting, continuing medical education talks and compensation from academic, non-profit or professional groups are allowed.
  • Speakers’ bureaus and other promotional activities are banned.
  • Activities that are “a genuine service to the community and that are solely for educational purposes” are allowed. 
  • Companies can’t require the use of their presentation materials or require that they approve materials a speaker will use, and talks cannot focus on a single drug, device or product.

Faculty must seek permission to give talks, and an independent committee must review those applications and the contract from the pharmaceutical or medical device company. Here is the scorecard:

Since the policy went into effect in June 2011, 50 requests were submitted  for review. Two were exempt. Of the applications reviewed, 29 (58 percent) were approved. And 19 (38 percent) were disapproved.

Read the new conflict-of-interest policy >>