Medtronic Hires Yale Experts for Spine Drug Review

In a bid to clear its name, Medtronic Inc is hiring top researchers at Yale University to review data on a spine surgery product that became suspect over potential conflicts of interest.

The world's largest medical device maker came under fire in June, when an article in The Spine Journal said that doctors paid by Medtronic had failed to report serious complications from its bone growth product Infuse.

Fifteen of the surgeons involved in reporting the drug's effects had reportedly received at least $62 million in the past decade.

The company is the subject of a U.S. Senate probe over the allegations.

Now it is paying researchers at Yale $2.5 million to conduct two systematic reviews of its data on Infuse, Medtronic said on Wednesday.

"Those (Spine Journal) articles created more confusion and raised questions about patient safety. We would like clarity on safety and efficacy of the product and bring a clear understanding that Medtronic is willing to do whatever it takes," Christopher O'Connell, president of Medtronic's Restorative Therapies Group, said in a telephone interview.

Infuse is a synthetic bone growth product often used as a bone graft substitute in spine fusions. It generated sales of about $750 million in fiscal 2011, according to Wells Fargo, and Wall Street analysts expect that revenue to decline due to the questions about its risks.

In articles published in The Spine Journal, the official journal of the North American Spine Society, a group of doctors called the industry-sponsored research biased and misleading that grossly underestimated the risks.

They said complications like cancer, sterility, infections and bone dissolution occurred in 10 to 50 percent of patients who received Infuse or a sister product in 13 clinical trials funded by Medtronic, but were not reported in research papers.

The Yale review will be headed by Dr. Harlan Krumholz, a highly regarded cardiologist.

Krumholz will be paid by Medtronic and serve as an intermediary, choosing experts who will evaluate the data.

A steering committee of medical experts and patients appointed by Yale will be led by Dr. Ezekiel Emanuel, Chair of the Department of Bioethics at the National Institutes of Health.


"This is an opportunity to change standards," Krumholz told Reuters. "The money has got to come from industry because no one else is going to step up. So how do you create a model that is fair to the company and that also serves the public?

"The two groups will work independently to answer the same questions: What's the quality of the data and what can you infer about the benefits and harms," Krumholz said. "That's pretty hard to rig."

Krumholz said Medtronic is the first company to agree to release all of its data — published and unpublished — on about 800 patient records.

The Yale review "appears to be a big first step in the right direction," Dr. Eugene Carragee, Editor-in-Chief of The Spine Journal, said in a prepared statement.

However, the findings may still be invalid since a subsequent analysis of original flawed data, such as in some of the industry-sponsored Infuse studies, will have little value.

"Unfortunately, the Yale University researchers will not be able to fix the study design flaws and assessment biases that were used in some of the original studies," he noted.

In addition, because the original Medtronic-sponsored research did not report any adverse events, the voluntary reporting by practicing surgeons was handicapped by surgeons and patients not recognizing many of the complications were related to the product, he said.

Finally, the most common use of Infuse today is posterior lumbar fusions and the randomized trial on this particular use was halted early on because of complications and adverse events, he noted.
"Consequently, the Yale group will still have very little controlled data to judge actual safety of the product," Carragee concluded.

The reviews are expected to be completed in six months and available to the public in 18 months.