Medtronic Inc. was shaken earlier this summer by an extraordinary medical journal investigation. The probers found that consultants to the health care device manufacturer took millions of dollars from the company and then wrote evaluations that downplayed, or ignored, serious complications linked to one of its products.
Now Medtronic, acknowledging that public trust in the Minneapolis-based company has been “challenged,” is giving a $2.5 million grant to Yale University to conduct analyses by two research teams. They will examine the safety and effectiveness of the controversial product, Infuse, a protein used to replace real bone during spinal fusion surgery.
The grant agreement is designed to keep the two analyses, which will be contracted out to outside research groups, independent of Medtronic influence. Experts said the pact would be groundbreaking in that Medtronic would release an unprecedented amount of information from clinical trials and other data.
In a news release, the company’s chief scientific officer, Dr. Rick Kuntz, called the plan “a novel and significant commitment to transparency and open-access scientific research.”
As The Wall Street Journal reports, he plan for the review was developed by Dr. Harlan Krumholz, a Yale cardiologist who has long argued that drug and device companies need to disclose much more patient data about their products. “Every day, doctors and patients are making decisions based only on a partial picture of the evidence that is relevant,” Dr. Krumholz said.
Editors of the medical publication that examined the previous Infuse research, The Spine Journal, found a systematic failure among the Medtronics-paid doctors to report serious complications ranging from increased risk of cancer to inflammatory reactions and fertility problems. Moreover, actual complication rates were 10 to 50 times higher than those estimated in the articles by the doctors paid millions by Medtronic for consulting work, the editors said.
STUART SILVERSTEIN
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