Carragee is hopeful about the broad ramifications of the Medtronic plan, but he also has concerns about the study of the spinal fusion product.
"There have been many years of repeated and categorical denials [of] associated complications by paid consultants or other surgeons with financial ties to the company," Carragee says. "Yale can get all the FDA reports in existence but because of the history of denying associated problems, they will have only the tip of the iceberg."
Harlan Krumholz, MD, a professor of cardiology and investigative medicine at Yale Medical School, will lead the independent review.
Krumholz's strategy "is to ask the right question and pick the right measurement – and it can get the right answer," Yale Medical School's Web site notes. Forbes Magazine also has called Krumholz "The Most Powerful Doctor You Never Heard Of." In the spinal surgery field, Krumholz's name will certainly become more known. Whether he pushes beyond the "tip of the iceberg" as Carragee fears, is not yet known.