By Debra Sherman
(Reuters) - Medical device maker Medtronic Inc edited health journal articles and paid doctors millions of dollars for company-sponsored studies of its Infuse bone-grafting product used in spinal surgery, according to a U.S. Senate report published on Thursday.
There were questionable ties between Medtronic and physician consultants who tested and reviewed the company's product, the U.S. Senate Finance Committee said in the report, which concludes a 16-month investigation covering 5,000 documents relating to 13 studies of Infuse.
Medtronic paid about $210 million in royalties and consulting fees to the authors of company-sponsored studies between November 1996 and December 2010, the report said.
Those sponsored studies failed to mention complications from the product, including male sterility, an increased risk of cancer, infections, bone dissolution and worsened back and leg pain.
"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," the committee's report said.
Chuck Grassley, an Iowa Republican and senior member of the committee, said in a statement: "The findings also should prompt medical journals to take a very proactive approach to accounting for the content of the articles, along with the authorship of the articles and studies they feature."
The Senate committee, which has sole jurisdiction over U.S. government health programs Medicare and Medicaid, 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.
In response, Medtronic said in a statement on its website it "vigorously disagreed" with the allegations of influencing or authoring the publications or under-reporting adverse events.
"In addition, the report's characterization of payments received by physicians is also misleading and unfair," Medtronic said.
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 at that time that 13 Medtronic-sponsored studies related to Infuse had reported no adverse events.
"While the report confirms what was reported in the June 2011 issue of The Spine Journal, the committee's access to Medtronic's internal documents presents a more detailed and disturbing picture of what can go wrong when ethics and patient safety are compromised for profit," the North American Spine Society said in a statement.
The U.S. Food and Drug Administration approved Infuse in 2002 to stimulate spinal bone growth in patients with a degenerative disease affecting the lower spine.
However, the product is used mostly off-label, often for repairs to the cervical, or neck, spinal area.
According to Medtronic, Infuse has been used to treat more than 500,000 patients and generated sales of about $800 million in fiscal 2011.
Robin Young, whose firm RRY Publications publishes Orthopedics This Week, said he believes Medtronic, which makes a host of other non-orthopedic medical devices, has improved its practices substantially in recent years.
"Medtronic went through strict compliance changes. It was a top-to-bottom commitment to compliance, with wholesale changes. It's a multi-year process and a change of culture, and it's much different than it was even seven years ago," Young said.
Shares of Medtronic were trading at $41.97, up 28 cents, in early activity on the New York Stock Exchange.
(Reporting by Debra Sherman in Chicago; Additional reporting by Vrinda Manocha in Bangalore; Editing by Greg Mahlich, Bernadette Baum and Dale Hudson)