Medtronic has almost developed a corporate motif for its cooking the research books to reflect kindly on its own products. U.S. Senate investigators in Oct. 2012 said Medtronic paid doctors to manipulate Infuse studies to present Infuse as safer than it really is. In 2011, Medtronic agreed to pay $23.5 million to settle accusations that it paid doctors in a kickback scheme to implant Medtronic pacemakers and defibrillators.
Medtronic was charged by the government with causing false claims submissions to Medicare and Medicaid. The scheme was proliferated by Medtronic’s using two post-market studies and two device registries to pay doctors illegal kickbacks.
In this kickback scheme, according to the Associated Press, Medtronic paid doctors roughly $1,000 to $2,000 a patient. The Feds contended Medtronic had solicited physicians for post-market research studies in order to prompt the doctors into using Medtronic devices. Postmarket studies are intended to assess medical devices or drugs after they have been approved by the Food and Drug Administration.
As part of the civil settlement in its kickback case, Medtronic did not admit wrongdoing.
Medtronic is, however, not alone among corporations tilting the playing field in favor of their products. The Justice Department recently reached settlements with two other major medical devices makers over similar concerns – Boston Scientific and St. Jude Medical.
Medtronic’s actions have shown that the current FDA system of evaluating drug research by vested interests and letting those companies design their own post-market research studies needs some attention or adjustment. The health of all may depend on our doctors being able to review objectively presented drug and device research, that in which the profit motive is back burnered in favor of safety concerns.
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by Matthews & Associates
