Yale will assemble a panel of 12 to 15 experts and commission two clinical research organizations to analyze data and review the safety and effectiveness of Medtronic’s Infuse product, which has come under scrutiny in recent months.
Medtronic, Inc., has provided a $2.5 million grant to Yale University for an independent investigation of the company’s bone-growth product—which has come under fire in recent months.
The Fridley-based medical device giant’s Infuse product made headlines following reports that scrutinized the product and the studies conducted to ensure its safety.
Medtronic said Wednesday that it will provide Yale with both published and unpublished data from company-sponsored clinical trials, as well as reports about problems that were filed with the FDA. Yale will then assemble a panel of 12 to 15 experts and commission two clinical research organizations to analyze the data.
Nationally known physician Harlan Krumholz—who is also the Harold H. Hines Jr. professor of internal medicine, epidemiology, and public health at the Yale School of Medicine—will oversee the review process. Yale plans to complete the review of the data within six months and make it available to the public within a year and a half.
When asked how Medtronic chose Yale for the review, company spokesman Steven Cragle told Twin Cities Business that it was looking for both an institution and an individual that would be regarded by all stakeholders as “beyond reproach.”
“I think if you ask anybody . . . Harlan would be at the top of their list,” Cragle said Thursday. “He’s renowned in the clinical community as one of the foremost experts in clinical outcomes research. Harlan has been a rather public and vociferous, in some cases, critic of the industry. We were looking for somebody who would be entirely objective beyond reproach.”
The Infuse product is a bioengineered bone-growth protein that has been used in spinal fusion procedures for the past nine years. The New York Times reported earlier this year that Infuse is used in about half of the 80,000 anterior lumbar fusion procedures performed every year in the United States.
The Spine Journal recently published two articles about the product, one that claims the product may increase the risk of sterility in men, and another that claims that the product’s adverse effects were not reported in clinical research. Those effects reportedly include inflammation, back pain, infections, and potentially life-threatening complications. The publication pointed out that researchers for 12 of the product’s 13 industry-sponsored studies had multimillion-dollar “financial associations” with Medtronic.
Additionally, two members of the Senate Finance Committee sent a letter to Medtronic in June, seeking information about the use of the Infuse product and payments that the company made to its clinical investigators. And media reports surfaced in April indicating that the Department of Justice was investigating the marketing of the Infuse product.
Medtronic has defended the product against criticism, and CEO Omar Ishrak issued a statement in late June, saying that patient safety is of utmost importance to the company and that the articles don’t raise questions about the data that Medtronic submitted to the U.S. Food and Drug Administration (FDA) during the device approval process.
On Wednesday, Ishrak said in a statement: “Integrity and patient safety are Medtronic’s highest priorities, so it is important that a respected academic institution provide a publicly trusted source of information by way of these systematic reviews and the novel data access program for researchers.”
“This project, including making the data accessible to all researchers, is intended to establish a landmark model for data transparency—a breakthrough in balancing the needs of industry with the public’s desire for an independent review of the complete set of data,” Krumholz said in a statement. “If successful, this new approach can become standard practice. Medtronic is taking an important leadership position that we hope others will follow.”
About a month ago, Larry Biegelsen—a senior analyst with Wells Fargo Securities—released a report indicating that controversy surrounding the Infuse product may force Medtronic to sell its spine business. He outlined what he sees as several possible outcomes for the company’s spine division—including criminal penalties, class-action lawsuits, decreased sales, and even the potential sale of the business.
Medtronic is the world’s largest medical device company and Minnesota’s seventh-largest public company based on revenue, which totaled $15.93 billion for the fiscal year that ended April 29. Citing analysts, The New York Times reported that sales of Infuse hit about $900 million during that period.