Medtronic, the manufacturer of spine fusion product Infuse, has hired Yale University researchers to review patient data and adverse event reports for the product.
Photo by planetc1 via Flickr
The review follows months of reporting by John Fauber for the Milwaukee Journal Sentinel and Medpage Today that have raised questions about the independence of doctors involved in clinical trials for the product.
The Wall Street Journal’s John Carreyou and Tom McGinty also used their paper’s Medicare data stockpile to look at the conflicts of interest and royalty money that drive the popularity of spine fusion treatments whose effectiveness has been disputed.
Serious complications involving Infuse have gone unreported in medical journal articles that were written by doctors who have financial ties to Medtronic.
The June issue of The Spine Journal was devoted to unreported complications related to Infuse, revealing that “complication rates … were 10 to 50 times greater than the estimated complication rates revealed” papers co-authored by doctors with financial ties to the company.
In a statement about the review by Yale researchers, Eugene J. Carragee, M.D., editor in chief of The Spine Journal, says “this appears to be a big first step in the right direction” but points out three challenges that lay ahead for the reviewers.
I had spinal surgery in Sept. 2009 using the Medtronic BMP-2. The Fusion was done using a lateral approach, off-label. Several days after my surgery I started to experiance severe pain in my lower back, legs and feet. The pain was so severe at times i couldn’t walk, it would cause me to vomit. The pain never went away and after months of test the surgeon labeled me with “Failed Back Surgery Syndrome”. I had worked in Health Care, Cardiac Cath, I could no longer do my job and had to apply for SSD at the young age of 50. I just found out about the BMP cover up and finnally have an answer for what caused this horrible pain. My life will never be the same because of the greed of Medtronic and the people your suppose to trust, the doctors. I am going to file suit against all of them, will I win, I don’t know. But I will make sure that everyone knows what these people have done to thousands of innocent people. Once my lawsuit is done I will use any money I recieve and the little I get from SSD to bring these people down. I thank you for your efforts to bring this crime into the publics attention. Thank You