In the latest installment of his ongoing investigation for the Milwaukee Journal Sentinel and MedPage Today, John Fauber reports his discovery that physicians writing up a large-scale 2009 study “failed to identify a significant cancer risk” associated with Medtronic’s Amplify, a BMP-2 spine surgery product. At the same time, Fauber observes, Medtronic paid those same physicians millions.
The company and doctors had become aware of information on an additional cancer case, which pushed the concern to a critical level, at least two months before the paper was published, a Journal Sentinel/MedPage Today investigation found. Independent researchers say they had an ethical duty to report the cancer risk.
The researchers had information showing that at two and three years after being implanted with the genetically engineered protein, significantly higher numbers of Amplify patients were being diagnosed with cancer, but they did not report it on their paper.
In addition to interviews with experts and ethicists, Fauber’s investigation was heavily informed by his review of federal documents.
The Journal Sentinel found a full airing of the cancer question in more than 1,000 pages of U.S. Food and Drug Administration records. That information included FDA reports and information filed with the agency by Medtronic as part of its application to win approval for Amplify.