As part of their ongoing investigation into Medtronic’s spinal fusion products, Sentinel/MedPage Today has released details about a 2009 study publication in which researchers may have downplayed the cancer risks associated with bone morphogenetic protein-2 (BMP-2). The study was being used to help Medtronic gain approval for their second BMP-2 product, Amplify.
Cancer Cases Higher than Reported
In 2009, researchers issued findings from a trial of the spinal fusion product, morphogenetic protein-2 (BMP-2). The researchers had reportedly found that the number of cancer patients they had treated with BMP-2 had increased significantly, yet they failed to include these facts in their findings.
Medtronic, the company that paid for the research, and who was planning to use BMP-2 in its new spinal fusion device Amplify, was also conscious of these findings. They too failed to announce them. By choosing not to say anything about the findings, Medtronic breached an ethical standard, independent researchers say. Medtronic is already being investigated by the U.S. Senate Finance Committee and the Justice Department over the marketing of Infuse, their other BMP product which has already been approved by the FDA.
Experts Weigh in on the BMP-2 Cancer Link
The 2009 study has been under heat from experts who found several problems with the way the cancer cases were calculated and reported. The study authors had written that there were only eight patients who were diagnosed with cancer 24 months after being treated with Amplify compared to two patients who received the standard treatment (a graft of their own hipbone.) But experts say that the findings should have reflected that the actual cancer numbers were nine patients for those that had received Amplify and two for those who received bone grafts.
According to the FDA, at nine patients the cancer risk becomes pretty significant. The ninth cancer patient was a woman who underwent treatment with Amplify in 2003 and was diagnosed with stomach cancer in 2005. According to the researchers, the reason the ninth case didn’t make it into the study findings was because it was reported more than 24 months after BMP-2 was implanted. They blamed its absence from reports on the design of the study. Brook Martin, PhD, who analyzed the data, found an even higher number of cancer cases- 12 patients- in the Amplify group.
Experienced Defective Medical Device Attorney
Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.
If you or a loved one have been injured by or have developed serious side effects from the use of Medtronic’s Infuse or Amplify, contact Thomas J. Henry immediately. We are available 24/7, nights and weekends.
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