Senators Question Whether Medtronic Infuse Side Effects Were Covered Up

U.S. Senators are questioning whether researchers who may have covered up the potential side effects of Medtronic Infuse bone-growth products, did so because they were being paid millions of dollars by the manufacturer. 

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, wrote a letter to Medtronic on June 21, asking the company to release documents detailing communications with researchers over the development and testing of Infuse bone growth products.

The request comes after reports surfaced that the researchers, who had financial ties to Medtronic, appear to have hidden potential Infuse side effects, including an increased risk of fatal swelling of the neck, harmful bone growth and sterility.

The senators 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.

In a letter addressed to Omar Ishrak, Medtronic’s CEO, the senators remind the company that the finance committee controls Medicare and Medicaid, which reimburses medical device manufacturers.

The request comes after a Medtronic Infuse study published in the May edition of The Spine Journal contradicted Medtronic-sponsored researchers’ claims that sterility suffered by Infuse recipients was the result of surgical techniques. Other media reports have shown a growing concern in the medical community that some researchers who conducted clinical trials on Infuse were being paid by Medtronic and covered up some of the bone growth product’s potential side effects.

“These reports that doctors conducting medical trials while on Medtronic’s payroll may have hidden serious side effects for patients are deeply troubling,” Baucus said in a press release. ” Patients have a right to know the risks associated with their treatments, and medical device companies have a duty to disclose this information. We need to do everything we can to ensure companies aren’t concealing serious medical complications from patients just to increase profits.”

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.