The Senate Finance Committee, which began to investigate the off-label use of the product last year, has released a devastating report charging, among other things, that the Minnesota medical device maker improperly promoted the product and did not make certain disclosures in medical journal articles. A separate Department of Justice investigation into InFuse was closed without any action.
Specifically, some of the charges in the Senate Finance Committee staff report are:
- Medtronic was heavily involved in drafting, editing and shaping the content of medical journal articles authored by its physician consultants who received significant amounts of moneythrough royalties and consulting fees from Medtronic. The company’s significant role in authoring or substantively editingthese articles was not disclosed in the published articles. Medical journals should ensure industry role contributions be fullydisclosed.
- An email exchange shows that a Medtronic employee recommended against publishing a complete list of adverse events possibly associated with InFuse in a 2005 Journal of Bone and Joint Surgery article.
- Medtronic officials inserted language into studies that promoted InFuse as a better technique than taking a bone graft from the pelvic bone (autograft technique) by emphasizing the pain of the autograft technique.
Medtronic issued a statement immediately:
Medtronic does not agree with many of the findings in the staff report. In particular, Medtronic vigorously disagrees with any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events.
Now the obvious question is will the Yale independent review, provided that it says InFuse is safe and thus vindicate Medtronic, redeem InFuse? (The results of the review are imminent)
My guess is no. There is some evidence that doctors have already moved away from the product — InFuse product sales have fallen sharply from the hey days, partly driven by the Spine Journal, which dedicated an entire issue to questioning InFuse.
In February, an analyst said that in her discussions with spine surgeons across the country, she got the sense that many were on to other products and some were using it mainly on older patients whose risk of developing cancer is not as high as in younger patients.
If the Yale review on InFuse is negative, on the other hand, Medtronic may be under pressure to sell the Spine division, in which InFuse belongs, something that has been suggested before.