Medtronic (MDT) has decided to provide a grant to Yale University to conduct two fully independent third-party reviews for the safety and effectiveness of its recombinant bone morphogenic protein-2 (rhBMP-2). The company will provide Yale with all available patient-data from the clinical trials.
Yale will take the help from a panel of experts and will set up two clinical research organizations to conduct analyses and ensure the findings are reproducible, and of the highest integrity.
Medtronic will provide a research grant of approximately $2.5 million to bear the costs of analysis and other operations, but would refrain from interfering in any other manner. Yale will expedite the reviews process to complete them within six months so that the data are available within 18 months
Medtronic has also decided to list all information regarding its clinical trials on ClinicalTrials.gov. These steps were taken to clear all clouds, as several questions were raised regarding rhBMP-2 in the recent past. Some articles were published on rhBMP-2 in Spine Journal.
According to a report issued in The Wall Street Journal (WSJ) on the Spine Journal finding, surgeons missed to mention the complications encountered with bone-growth protein in clinical trials.
The WSJ reported that the Spine Journal talked of many serious complications such as sterility, infection, bone dissolution and severe back and leg pain as well as cancer in 10-50% of patients who were treated with Infuse or a sister product in 13 clinical trials. These trials were funded by Medtronic and conducted by the surgeons during 2000 and 2010.
The chairman and CEO of Medtronic, Omar Ishrak, issued a statement regarding the published article. He considers integrity and patient safety as the company’s highest priorities. The recent initiative is an attempt to remove all concerns regarding clinical trial data.
Spinal is Medtronic’s second biggest segment, which has been witnessing several challenges over the past few quarters. During the last reported quarter, this segment generated $875 million in sales compared to $880 million in the year-ago period, down 1% (down 2% at CER). Revenues from Core Spinal and Biologics were $648 million (down 2% year over year) and $227 million (up 5%).
We currently have an Underperform recommendation on Medtronic.
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