Lieff Cabraser Heimann & Bernstein, LLP

Doctors Criticized For Conflicts of Interest Based On Payments From Medical Device Companies

The Milwaukee Journal Sentinel recently reported on an influential surgeon's $25 million-plus royalty income from Medtronic, the nation's leading medical device manufacturer. In 2009, Dr. Timothy Kuklo of the Walter Reed Army Medical Center in Washington, served as a consultant to Medtronic and later a U.S. Senate committee investigated him for allegedly faslifying data in an Infuse bone graft study.

Financial Relationships Betweeen Doctors and Device Manufacturers Are Institutional Tradition

Doctor-manufacturer relationships are not unusual - in fact, they are institutional. The Journal Sentinel reported that a 2007 study in the Journal of the American Medical Associaion found that "60% of department chairmen at medical schools had some kind of personal relationship with the medical industry, such as being a consultant, paid speaker or member of an advisory board."

These lucrative relationships have been glossed over in the past: Before the 2009 U.S. Senate Finance Committee investigation, University of Wisconsin doctors were only required to report outside income with the "top category being $20,000 or more." Under this reporting system, Dr. Zdeblick's Medtronic royalty income, which had already reached $4.6 million, was recorded only as being "$20,000 or more." 

Mass Device reported that Dr. Carl Elliot, professor of bioethics at the University of Minnesota, spoke of Medtronic's financial ties to researchers as more than simple conflict of interest - "Well, you could call it a conflict of interest, but I prefer the term 'corruption.'" 

Calls for Increased Accountability

The Bellingham Herald reported:

Until recently, readers of the Spine Journal would have to search around if they wanted to find out about an author's financial conflicts. But the journal is changing its policy so that study funding and the financial relationships of authors will be spelled out in ranges within the body of the article in the methods section. 

For instance if an author who receives seven-figure royalty payments, it will be identified as getting either $1 million to $2.5 million or more than $2.5 million. The article will also include information on who paid for the study. 

The penalty for deliberately not disclosing that kind of information could be substantial, including the retraction of the paper and possible barring of future submission. 

The new disclosure policies are part of a sea change in attitude about known sources of potential research bias, said Eugene Carragee, editor-in-chief of the Spine Journal and an orthopedic surgeon at Stanford University.