Independent reviews find less benefit, more harm than first reported for bone protein product

Brenda Goodman

About Brenda Goodman

Brenda Goodman (@GoodmanBrenda), an Atlanta-based freelancer, is AHCJ’s topic leader on medical studies, curating related material at healthjournalism.org. She welcomes questions and suggestions on medical study resources and tip sheets at brenda@healthjournalism.org.

Efforts to correct biased and dangerous medical studies are making more headlines.

Shortly after I posted about a new idea to correct missing and misreported research, I got an email from AHCJ member John Fauber, an investigative reporter at the Milwaukee Journal Sentinel.

His latest story for the Journal Sentinel and MedPage Today involves an extensive undertaking coordinated by Yale University to correct the record on a product made by Medtronic called Infuse. The project is called YODA, for Yale Open Data Access. (Read more..)

Infuse — officially a device — consists of a metal cage fitted around a sponge that is soaked in a genetically engineered protein. The protein is supposed to promote bone growth and healing. It works, but perhaps too well. Side effects linked to its use include bone overgrowth that can trap and irritate nerve roots causing chronic pain. It has also been tied to a complication called retrograde ejaculation, which leads to sterility in men.  Patients who receive infuse also experienced more problems with wound healing and more cancer.

All in all, pretty devastating outcomes for patients who were hoping to feel better after their back surgeries.

According to a 2011 New York Times story, none of those adverse events were reported in the 13 original studies of the product, which were funded by Medtronic and written and edited by a doctor who was handsomely paid by the company.

It was only after a series of reports by Fauber for the Journal Sentinel and MedPage Today, a congressional investigation, and a critical review of data on Infuse submitted to the FDA by Dr. Eugene Carragee, editor of The Spine Journal, that the truth about the dangers began to surface.

Under scrutiny, Medtronic paid $2.5 million dollars to Yale to establish the YODA program. Yale, in turn, chose two universities to conducted separate and independent reviews of all the Infuse data. Those reviews were published last week in the Annals of Internal Medicine.

Researchers found substantial evidence of biased reporting on Infuse in medical journals and no evidence that it is more effective than the traditional method used in spine surgery, according to Fauber’s story.

The second report showed that while Infuse improved pain and quality of life six to 24 months after surgery, those measures fell below “clinically meaningful thresholds.”

According to Fauber’s report:

“It is hard to find a clear advantage for using it,” said Mark Helfand, co-author of the report from Oregon Health & Science University, where he is a professor of medicine. “When you add in the potential harms, it tips the scale further toward not using it.”

Even Medtronic’s critics have praised the company for its transparency through the YODA process.

But they also point out that the program began its reviews only after more than a million people had been implanted with the device.

Nothing can replace what some patients have lost because the evidence wasn’t honestly reported in the first place.

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