This month, the Minneapolis Star-Tribune published a series of reports on its investigation of payments made to orthopedic surgeons by medical device maker Medtronic. Unsealed documents from an ongoing lawsuit suggested that this company also made some strikingly large payments to orthopedic surgeons who perform spine surgery. The Star-Tribune's first article focused on a single surgeon:
Dr. David Polly's reputation precedes him and it's worth a lot. Among spine surgeons, this rather unremarkable-looking 51-year-old is a rock star.
Arrayed before him as he spoke at the annual Design of Medical Devices Conference at the University of Minnesota were two dozen doctors, engineers, students and medical device company representatives, some furiously scribbling notes. In this reverential group, Polly's mention of a particular surgical technique or medical device would be golden.
They already knew much about this man with a 29-page résumé. The head of orthopedic spine surgery at the university, Polly has led close to 80 research studies and co-written at least 90 scientific papers on repairing aging, injured and contorted spines. In an era of active baby boomers, many with ailing backs, Polly's specialty is a growth industry.
Polly's paid consulting relationship with Medtronic Inc., the global leader in medical devices, was not a focus of discussion that muggy April day. The Fridley-based firm makes the plates, screws, cages, neurostimulators and bone grafts that largely comprise the toolbox of spine repair.
A recently unsealed whistleblower lawsuit, and Congressional and Justice Department investigations, are finally bringing into public view the practice of handsomely reimbursing top doctors to consult for medical device companies.
The $344,375 in consulting fees Polly allegedly received from Medtronic in 2006, and similar amounts in 2004 and 2005, are only emerging because of a complaint filed in a whistleblower lawsuit by two former Medtronic employees in U.S. District Court in Massachusetts.
Another article focused on another surgeon:
Dr. Kenneth Burkus is quite confident his eight-year relationship as a paid consultant for Fridley-based medical device maker Medtronic Inc. hasn't compromised his patients' care.
The Columbus, Ga., surgeon said he receives royalties for helping to develop the company's artificial neck disc and other products. A whistle-blower lawsuit filed in Massachusetts federal court alleges that he was paid $416,775 for consulting work in 2006.
I thought it might be useful to examine the extent that these two surgeons have disclosed their relationships with Medtronic in their published work.
Dr Polly is by far the more prolific writer. Most of his recent work is in Spine. So I looked at a 2008 review article on treatment of scoliosis for which he was senior author.(1) This is what was disclosed in the article:
Although one or more of the author(s)has/have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of the manuscript, benefits will be directed solely to a research fund, foundation, educational institution, or other non-profit organization which the author(s) has/have been associated. One or more authors has/have received benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consultancies, royalties, stocks, stock options, decision making position.
That was really specific, wasn't it. The disclosure does not identify which author received payments, what company made the payments, how much they were, or what their purpose was.
I found two recent articles authored by Dr Burkus, both again in Spine. The most informative disclosure statement was from an article by Dimar et al(2)
One or more authors has/have received benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consultancies, royalties, stocks, stock options, decision making position.
That wording seems familiar, and presumably is the boilerplate favored by Spine. Of course, it is no more specific here than it was before.
The new investigations by the Star-Tribune suggest that huge payments to orthopedic surgeons by medical device companies are hardly confined to those related to hip and knee prostheses, and that spine surgeons seem no more eager to disclose these payments in any detail to the readers of their research articles than were surgeons who specialized in hip and knee replacement.
So I get to repeat myself. In my humble opinion, a disclosure that a journal article's author received some sort of "benefits" from a company does not quite have the impact of a disclosure that the author received hundreds of thousands of dollars in consulting fees. My concern is that surgeons of the stature of those mentioned in these articles have numerous opportunities to influence the practice of their colleagues, by informal conversations, formal talks, and published writing. These colleagues at least should have the opportunity to decide for themselves whether the surgeons' enthusiasm for spine surgery, especially involving the use of specific products, might just have been a bit influenced by making hundreds of thousands of dollars a year in consulting payments from the manufacturers of those products.
Again, there has been a lot of discussion lately about the effects of small gifts, pens, mugs, and pizza lunches, on physicians. Even small gifts have been shown to influence how people think and act. But if small gifts have some effect, what sort of effect would arise from consulting fees almost enough to make a doctor rich? Inquiring minds want to know.
This is another argument for requiring full and detailed disclosure of all payments made to physicians, and to health care academics, and health care decision makers, beyond their usual salaries or fees, and that could have any bearing on their clinical or health care decision making.
1. Lenke LG, Kuklo TR, Ondra S, Polly DW. Rationale behind the current state-of-the-art treatment of scoliosis (in the pedicle screw era). Spine 2008; 33: 1051-1054.
2. Dimar JR, Glassman SD, Burkus KJ, Carreon LY. Clinical outcomes and fusion success at 2 years of single-level instrumented posterolateral fusions with recombinant human bone morphogenetic protein-2/compression resistance matrix versus iliac crest bone graft. Spine 2006; 31: 2534-2539.