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According to a new report, surgeons who received millions of dollars from Medtronic allegedly failed to report serious complications and side effects that affected patients receiving the Medtronic Infuse bone graft product during clinical trials.
The report, published in The Spine Journal, found that approximately 10% to 50% of patients who were part of clinical trials experienced Medtronic Infuse complications, such as cancer, pain, infections and sterility. However, those problems failed to appear in a number of studies published by researchers with financial ties to the manufacturer.
According to the report, 15 of the researchers who took part in the studies received $62 million from Medtronic over a 10-year period. Despite being peer-reviewed, a number of publications failed to catch what should have been obvious discrepancies, according to the study.
The findings come just days after two U.S. senators expressed concern over the allegations and wrote a letter to Medtronic seeking answers.
Senator Max Baucus, a Montana Democrat who chairs the Senate Finance Committee, and Senator Charles Grassley, an Iowa Republican who is the committee’s ranking member, are asking Medtronic to turn over all communications with medical journals, clinical investigators, the FDA and its advisory boards, and physician consultants that pertain to Infuse complications. The senators are also looking for detailed accounts of payments to researchers involved with Infuse clinical trials and a trove of other documents.
Medtronic’s new Chief Executive Officer, Omar Ishrak, has admitted that the new study was worrisome and announced that the company would investigate questions regarding researchers’ conflicts of interest. The company expects to have a report on the issue in 90 days. Medtronic offiicials noted that data Medtronic submitted to FDA on Infuse was not in question.
Medtronic Infuse is a bioengineered bone morphogenetic protein (BMP) used to encourage bone growth and replace spinal disks by filling the gaps between vertebrae. It was approved by the FDA in 2002 and generated about $900 million in sales for Medtronic in the last fiscal year.
Some health care professionals have long suspected a link between Infuse and male sterility, but in 2009 researchers sponsored by Medtronic found no link. Their findings raised questions by other medical researchers, who pointed out that Medtronic paid them millions in consulting fees. Their study, which determined that male sterility in the anterior lumbar fusion surgeries were the fault of the doctors, failed at the time to identify which patients were given Infuse. They later revealed that out of the six cases of sterility, five of the men were treated with Infuse.
Sterility is just the latest complication associated with Infuse, which already has a warning about the risk of male sterility on the label. The BMP has also been associated with serious and life-threatening complications caused by airway compression when used “off-label” in the cervical spine.
A number of patients have had to receive respiratory support tracheotomies, insertion of feeding tubes, anti-inflammatory medications and additional surgery after experiencing problems with Medtronic Infuse after a cervical spine surgery. This has often been caused by swelling of the neck and led to an FDA warning to healthcare providers in July 2008 that highlighted at least 38 reports of cervical spine fusion problems with Infuse. Most of these Medtronic Infuse problems occurred within 2 to 14 days after surgery.