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Concerns Mount for Medtronic Infuse BMP-2

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Prior to its entry into the market in 2002, orthopedic doctors were excited about how the back surgery product known as bone morphogenetic protein-2 would revolutionize orthopedic medicine.

But instead of success in fusing degenerated spines BMP-2 became a tainted biotech breakthrough associated with sordid corporate scandal involving many bit players.

The full saga of bone morphogenetic protein-2 (BMP-2) is yet to be told. At the heart of the scandal has been a circle of prominent surgeons whose research papers failed to report adverse events including cancer, infections, the painful growth of unwanted bone, and sterility in men among patients treated with BMP-2.

An investigation found that as a group those doctors received tens of millions of dollars in royalties from Medtronic, the company that markets BMP-2. Rarely were those payments disclosed in the published papers.

According to Bradley Weiner, MD, chief of spine surgery at Methodist Hospital in Houston and a deputy editor with the Spine Journal, over the years spine surgeons have become increasingly aggressive in their treatment of common back problems, often without adequate evidence these treatments actually benefit patients. And financial profits may also have a role in promoting aggressive strategies.

Vernon Tolo, MD, editor-in-chief of the Journal of Bone and Joint Surgery, said in an editorial that concern among doctors and the public about conflicts of interest "continues unabated." Some of the questionable BMP-2 research appeared in that journal, including a 2009 paper that failed to link the product to an increased cancer risk.

In June, editors at the Spine Journal published a scathing rebuke of BMP-2 research. An entire edition of the journal was devoted to a scientific and financial expose of the product and the financially conflicted doctors who tested and promoted it.

Amid the cries for reform are calls for the U.S. Food and Drug Administration to do more. According to Spengler, a Vanderbilt surgeon, someone at the FDA must have been aware that BMP-2 data it held didn't always match up with what was being put in the medical journal articles. But the agency, "didn't throw a flag," he said. "They have to be more aggressive."

According to FDA spokeswoman Karen Riley, many of complications associated with BMP-2 occur mainly in off-label uses, those for which it was not initially approved. And some of those complications are listed on the product label.

"The FDA does not regulate the practice of medicine," she said.

Monitoring what is being said in the medical literature would mean the FDA would have to play "journal cop," she said. "That's the job of the peer-review process, not the FDA," said Riley. "Shouldn't the journals be checking the label and asking the hard questions?"

Investigations by two U.S. Senate committees and the Department of Justice also are under way.

In August, Medtronic said it would spend $2.5 million for Yale University researchers to oversee an independent review of the controversial spine product.

Under the arrangement, Medtronic will provide the Yale reviewers with patient data from all BMP-2 clinical trials as well as all adverse events reported to the U.S. Food and Drug Administration since Infuse came on the market in 2002.

Last month, Yale selected two independent academic groups to perform the Infuse review. Medtronic will have no control over the process and will have to turn over all data, said Harlan Krumholz, MD, a professor of internal medicine at Yale.

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  1. John says:
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    The FDA should be stepping in and pulling this product off the market. 85% of Bmp sales are off- label. The patients are unknowing victims and do not see the warnings on the labels.The physicians in many cases are being paid more from Medtronic than from there jobs. I have lived this and my life is altered forever.