Oct 25 Medical device maker Medtronic Inc
edited health journal articles and paid physicians for
company-sponsored studies of its Infuse bone graft product used
in spinal surgery, a U.S. Senate Committee alleged in a report
published on Thursday.
"The company's significant role in authoring or
substantively editing these articles was not disclosed in the
published articles. Medical journals should ensure industry role
contributions be fully disclosed," said the report by the Senate
Committee on Finance.
It also accused the company of wrongly promoting Infuse, a
genetically engineered protein used in spinal surgery, as a
better technique than bone grafts from the pelvis and that
Medtronic paid about $210 million in royalties and consulting
fees to the authors of company sponsored studies between
November 1996 and December 2010.
In reaction Medtronic said in a statement on its website
that it "vigorously disagreed" with the allegations of
influencing or authoring the publications or under-reporting
"In addition, the report's characterisation of payments
received by physicians is also misleading and unfair," Medtronic
The inquiry by the Senate Committee began in June last
year, investigating whether surgeons paid by Medtronic did not
report complications associated with Infuse.
The Spine Journal reported that 13 Medtronic-sponsored
studies related to Infuse had reported no adverse events, in an
issue published a week after the inquiry.
The Committee report was published after reviewing over
5,000 documents produced by Medtronic related to Infuse trials.
Infuse, which was approved by the U.S. Food and Drug
Administration in 2002 for spinal surgery, generated sales of
about $800 million in the fiscal year 2011.