October 25, 2012
Senate Committee: Medtronic Inc Paid For Good Product Reviews
Michael Harper for redOrbit.com — Your Universe Online
Medical device maker Medtronic Inc may have felt as if they had a real best-selling product on their hands when they released Infuse, a bone-grafting product to be used in spinal surgery to spur the growth of new bone. However, according to a new investigation by some U.S. Senators, Medtronic may have been a little too excited about this product and began editing health journal articles about their product. The Senate board also found Medtronic had paid millions of dollars in “consulting fees” to doctors to promote Infuse. All told, Medtronic has been found to have helped write and edit at least 11 medical journals about Infuse, according to the U.S. Senate report.During this 16-month investigation, the U.S. Senate Finance Committee studied some 5,000 documents related to 13 different studies of the Medtronic product. The report also found Medtronic had paid a total nearing $210 million in both consulting fees and royalties for these positive journal studies and reviews between 1996 and 2010. While these authors were paid to focus on the positive aspects of Infuse, the negatives were left untouched. According to Reuters, Infuse has been found to lead to complications, such as an increased risk of cancer, infections, male sterility and an increase of 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,” according to the financial committee´s report.
Medtronic has released a statement concerning these new findings, saying that although they cooperated throughout this report, they are none too pleased with the results.
“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,” reads the Medtronic reply.
“In fact, Medtronic reported to the FDA the potential adverse events addressed in the staff report, and these risks were reflected on the product´s FDA-approved label. In addition, the staff report´s characterization of payments received by physicians is also misleading and unfair. The vast majority of such payments were royalty payments made to compensate physicians for their intellectual property rights and contributions, not consulting payments.”
Medtronic also mentioned the payment of royalties to doctors is not only appropriate, but quite common in the world of medicine and medical reviews.
This investigation began in June of last year as these senators began to look into whether surgeons had responsibly reported the negative effects of Infuse. In June 2011, the Spine Journal featured 13 Medtronic-sponsored studies, none of which mentioned any adverse effects of the product.
The North American Spine Society also responded to this investigation, saying: “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.”
Now, one Yale University professor of internal medicine, epidemiology and public health will begin to conduct his own independent analysis of Medtronic´s own Infuse data, which is set to include a database of any and all patient risks. According to Bloomberg, Medtronic is even paying $2.5 million for this analysis.
“Sometimes what you are reading about in a study may not be everything,” said Harlan Krumholz, the professor conducting the study.
“We have to change the way this kind of science has been conducted.”