Doctors and Health Care Industry Consulting: Ethicists Prescribe Reform

University of Minnesota expert billed Medtronic for impartial review

By Christopher Snowbeck

Back in 2005, Dr. David Polly participated in a review of a new technology in spine surgery by an influential nonprofit group.

After he concluded the work, the University of Minnesota expert submitted a bill for some of his time to Fridley-based Medtronic.

Four years later, leaders of the nonprofit group - the Bloomington-based Institute for Clinical Systems, or ICSI - say they wouldn't have let Polly participate in the review had they known about the billing arrangement. Technology reviews by ICSI are supposed to be impartial, they say, and a Medtronic device was among those being evaluated.

"I was shocked," said John Sakowski, the chief operating officer at ICSI, who learned of Polly's bill with the recent release of Polly's records by Sen. Charles Grassley, R-Iowa.

Although surprised, Sakowski said ICSI is not accusing Polly of wrongdoing in the matter. The nonprofit group didn't specifically ask whether the surgeon was billing an interested party for working on the review, and ICSI said the results generated by the group were solid - even with the apparent conflict of interest.

Medical ethicists say they have questions about how both ICSI and Polly acted during the episode, but they conclude that the moral of the story goes to a much broader point: Disclosure requirements throughout the health care industry have been woefully lacking.
"More independent control of financial relations is needed, clear conflict-of-interest rules are needed, and investigators have to receive proper education about conflicts of interest," said Trudo Lemmens, a medical ethicist at the University of Toronto.

Founded in 1993, ICSI is recognized nationally as a leader in the movement toward what's called "evidence-based medicine" - an attempt to rigorously ground health care practice in science, while weeding out other influences. It comprises 57 medical groups in the region and is financially supported by six of the region's health plans.

The nonprofit claims credit for helping Minnesota become the first state to build medical care around the systematic use of best medical practices based on science. While the group no longer conducts technology-assessment reports like the one Polly participated in, ICSI conducted more than 80 such reviews to develop clear evidence-based statements about the safety and effectiveness of emerging technologies.

Polly's bill for working on the ICSI review was just one of several hundred items in billing records released last month by Grassley. The senator has been probing the financial ties between doctors and medical companies for several years and has introduced federal legislation that would require more public disclosure.

The records released last month showed how Polly accumulated nearly $1.2 million in consulting bills to Medtronic between 2003 and 2007. Compared with the grand total, the bill for work at ICSI was a drop in the bucket.

Polly worked for 2 1/2 hours at a work group meeting July 26, 2005, according to Grassley's records, and billed Medtronic for $1,250.

In an interview, Polly said he billed Medtronic for the time because the company wanted to learn from him how technology-assessment groups were analyzing data about spine technology under review - artificial discs for use in the lumbar spine.

At the time, the only artificial disc approved for use in the U.S. was from medical products giant Johnson & Johnson, which declined to comment for this story. Medtronic's device was still in development, but Polly rejected any suggestion that Medtronic paid him to influence the review and thereby slow adoption of a competitor's technology.

The final ICSI report concluded that the evidence available at the time did not support routine use of artificial discs, and the verdict applied to devices from all manufacturers, including Medtronic. Company officials were "undecided" about whether such a conclusion was good or bad for Medtronic, Polly said, because they wanted to see their own product move forward.

Medtronic paid Polly for his time on the review, the doctor said, because the company wanted help with its own product. The company knew it would have to answer questions from reviewers such as the technology-assessment group, and Polly said he gave Medtronic insights into those questions.

"What I recall is that Medtronic valued my understanding of the technology-assessment review process, since they were facing that down the road from multiple payers and organizations, and they want to understand the process - not the specific event," he said. "Having that insight helps the company say, 'Can we potentially do our studies better to generate the best possible information for the process?' "

ICSI officials say the artificial disc report was not skewed by Polly's participation. Instead, it reflects the evidence that was available, they say.

Dr. Charles Rosen, a spine surgeon at the University of California-Irvine, seconded that view of the evidence for artificial discs in 2005. Rosen has been an outspoken critic both of the rush to adopt artificial discs and the money that companies pay physician consultants such as Polly.

"The evidence-based medicine folks won," Rosen said of deliberations across the country about artificial discs.

Even so, ICSI leaders say they probably will change the way they police conflicts of interest because of the Polly episode. In the future, physicians who work with the organization likely will be asked directly whether they are submitting bills to third parties for that work, said Sakowski, the group's chief operating officer.

Back in 2005, the organization asked doctors to make a broad disclosure of paid consulting relationships with any companies and to describe the nature of the work and the approximate value of the compensation.

Such disclosures by themselves don't necessarily disqualify an expert, but they are made known within ICSI and its publications so the group's process is transparent.

Sakowski could not say exactly what Polly disclosed to the group in 2005 by way of conflicts of interest because ICSI staff could not locate the paperwork.

"The nonprofit made a mistake, although it's a common one," said Dr. Adriane Fugh-Berman, a medical ethicist at Georgetown University. "They asked someone with a financial interest to assess a therapy objectively."

Lemmens, the University of Toronto expert, said he questioned Polly's conduct in the matter, as well.

"Being paid by a device company for attending a meeting in which one of its products is being discussed seems to me a clear example of a situation that under standard conflict-of-interest guidelines has to be disclosed," Lemmens said.

"If the not-for-profit organization requested disclosure of 'consulting relations,' it seems to me clear that it expected, back in 2005 or even much earlier, to be informed of the fact that an expert was being paid by a company for attending the meeting in which its products are being discussed," he added.

But Polly said such judgments were not so clear at the time and still are a matter of some debate.

"People can have legitimate differences of opinion on this," he said last week. "I complied with all disclosure requests asked of me."

Christopher Snowbeck can be reached at 651-228-5479             651-228-5479