Sen. Grassley Inquiry - Academic Doctors And Device Makers Who Love Them

U. of MN

Sen. Charles Grassley is uncovering more tangled financial relationships that exist between academic researchers and the medical device makers whose products they promote.

His latest focus - Dr. David W. Polly Jr., an orthopaedic surgeon with the University of Minnesota spine service who also works as a consultant for medical device maker, Medtronic.

Sen. Grassley (R-Iowa) has written to the university’s president raising the question of a possible conflict-of-interest after Dr. Polly took part in research on a Medtronic bone-growth product, Infuse, under a Defense Department grant, reports the Wall Street Journal.

Dr. Polly received $1.14 million from Medtronic for his consulting services between 2004 and 2007 and the company sponsored a trip to Washington during which Dr. Polly urged a Senate committee to fund research into spinal and limb injuries suffered by soldiers, which he did not disclose as industry-sponsored.

He also told the university that Medtronic made the only bone-growth product on the market. Sen. Grassley pointed out in his letter that Stryker Corp has a competitor called OP-1.

Dr. Polly has said in a recent radio interview and to the university committee that Medtronic medical device was the only one commercially available.

Columbia University

Dr. Martin Leon is under the spotlight of Sen. Grassley and Sen. Herb Kohl, Democrat of Wisconsin, who have written Columbia University about millions in payments from medical device makers that Dr. Leon may not have revealed, while promoting the company’s heart devices.

“Dr. Leon appears to have failed to report millions of dollars that he has received in outside income,” their letter stated.

The senators are focusing their attention on the Cardiovascular Research Foundation (CRF), a nonprofit organization linked to the university that provides services to device makers, including developing and testing products such as stents.

With a budget of $57 million in 2007, their annual meeting is often a place to showcase products developed by companies in which Dr. Leon and others have a financial stake. In fact, the CRF is honoring Dr. Leon at a gala event at the Waldorf-Astoria in NYC on October 22.

The New York Times reports on one example. Device maker, Edwards Lifesciences, reportedly paid Dr. Leon $6.9 million in 2004 to purchase a heart valve company he helped found. Dr. Leon told Business Week he donated his rights to those payments to a school, but did not identify the facility.

Columbia University revised its conflict-of-interest practices last July to eliminate the appearance of bias in research.

“Such situations do not necessarily imply wrongdoing or inappropriate activities. However, in a research university setting, they can compromise, or be perceived as compromising, important academic values, research integrity, or the university mission,” the policy says.

The policy requires disclosure of financial interests to peers and the public.

Meanwhile Dr. Leon has amended his filings with the university to include payments from Boston Scientific, Johnson & Johnson, Medtronic and the Volcano Corporation. Kohl and Grassley report there is an approximately $8 million discrepancy between the income reported by Leon and that reported by the companies.

Sens. Kohl and Grassley are continuing looking into some 20 Columbia University heart doctors probing their connection with the foundation.

Sen. Grassley is aggressively advocating transparency in the medical establishment and is promoting the Physician Payment Sunshine Act, which will require drug companies and medical device makers to disclose any payments of value above $500 to physicians. That information would then be disclosed on a government website. #