Sunday, August 9, 2009

Captain Renault: I'm shocked, shocked to find that gambling is going on in here!

[Dr. David Polly bills Medtronic for impartial review...]

From the Pioneer Press:

Doctors and health care industry consulting: Ethicists prescribe reform

University of Minnesota expert billed Medtronic for impartial review

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.

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.

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.

"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."

"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."

No comments: