A new report published in The Spine Journal adds to the controversy surrounding a bone-growth product made by Fridley-based Medtronic, Inc. But Medtronic's new CEO defended the company, stating that the product is safe for use under the approved applications.
Medtronic received approval for its Infuse product from the U.S. Food and Drug Administration (FDA) in 2002.There were 13 industry-sponsored studies conducted regarding the safety of the product, and no adverse effects were reported. But a review of FDA documents and other publications revealed "internal inconsistencies" and unpublished adverse events, according to the new article published by The Spine Journal.
The adverse reactions included inflammation, back pain, infections, and potentially life-threatening complications. Another study recently published by The Spine Journal found that male back-surgery patients treated with the Infuse product experienced higher rates of sterility.
The authors of the report released on Tuesday claim that an investigation showed that the actual patient risk associated with the product could be between 10 times and 50 times greater than what was reported in the original industry-sponsored studies.
The discrepancies "suggest possible study design bias in the original trials, as well as a clear increased risk of complications and adverse events" for patients receiving the product, the article states.
The report points out that the "financial association" between Medtronic and researchers of 12 of the 13 was a median of $12 million to $16 million per study.
The new report comes shortly after two members of the Senate Finance Committee sent a letter to Medtronic seeking information about the use of the Infuse product and payments that the company made to clinical investigators.
Omar Ishrak, who assumed the role of CEO at Medtronic earlier this month, issued a statement defending the company.
"Integrity and patient safety are my highest priorities," he wrote. "While The Spine Journal articles raise questions about researchers' conclusions in their published peer-reviewed literature, the articles do not raise questions about the data Medtronic submitted to the FDA in the approval process or the information available to physicians today through the instructions for use brochure attached to each product sold."
Medtronic has for several years led the industry in "reforms designed to eliminate or mitigate conflicts of interest," Ishrak wrote. "We will continue to investigate questions surrounding researchers' potential conflicts of interest, refine our policies as warranted, and strive to lead the industry in ethical and transparent business practices."
Read Ishrak's entire statement, as well as "additional company perspective," here.
View The Spine Journal's report and associated articles here.