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Continued: Long-awaited Yale study raises questions about integrity of previous studies of Medtronic's Infuse.

  • Article by: JAMES WALSH , Star Tribune
  • Last update: June 18, 2013 - 5:45 AM

Dr. Brian Zubac, a spine surgeon in Reston, Va., has used and researched Infuse.

“It has been the single greatest thing for my practice and my patients,” he said. “It has revolutionized what I do.”

It substantially increases the fusion rate for his patients who need multiple vertebrae fused, said Zubac, who added that he is not compensated by Medtronic and owns no stock. He has had good success using it on patients who have had poor surgery outcomes using a hip bone graft. Now, with the Yale results saying there is no difference between Infuse and the less expensive hip graft, he said he worries that insurance won’t pay for it. That, he said, will take a tool out of his hands.

“I’m pretty sure I’m going to have to chop a lot more hip bone out,” he said.

A new fusion option

Trouble emerged for Infuse when allegations surfaced that Medtronic was coaxing doctors to use it in ways regulators hadn’t approved — such as in neck surgery. In fact, Infuse was used more often in such “off-label” procedures, researchers said. In 2008, the FDA issued a warning after reports of excessive bone growth harming patients surfaced. While it isn’t illegal for doctors to use devices as they see fit, companies cannot market unapproved uses.

Several former Medtronic employees, including the spine business’ onetime general counsel, filed whistleblower lawsuits alleging that the company courted doctors with rich consulting deals and perks.

In 2006, Medtronic paid $40 million to settle with the Justice Department but admitted no wrongdoing. In May 2012, federal prosecutors closed an investigation of Infuse after finding no wrongdoing.

In the summer of 2011, a panel of spine experts reviewed the 13 original studies of Infuse and found that authors with financial ties to the company reported 10 to 50 times fewer complications with Infuse than were found in FDA reports and in other documents. Complications include different types of cancer, male sterility, infection and inappropriate bone growth. That review was published in the Spine Journal. Congress later launched an investigation.

In October, a U.S. Senate Finance Committee report alleged that Medtronic was heavily involved in shaping the content of medical journal articles about Infuse. The report raised questions about research conducted by physicians who received $210 million in royalties and consulting fees over 15 years from the Fridley-based company.

Medtronic denied it improperly influenced peer-reviewed reports or that it sought to underreport harm. Medtronic also called the report’s characterization of payments to physicians “misleading and unfair.” The company said most payments were made to compensate physicians for their intellectual property rights.

In August 2011, after the Spine Journal published its study, Medtronic agreed to grant Yale University researchers $2.5 million to determine the safety and effectiveness of Infuse. Dr. Harlan Krumholz, a nationally known physician and advocate of patient safety and transparency in clinical studies, led the effort as part of the Yale University Open Data Access (YODA) Project.

He said Medtronic’s decision to share its data was unprecedented. The review raises questions over “how much we know and who is clearly benefiting from it.”

Many clinical studies do not give the whole story about a product, Krumholz said. He hopes that Medtronic’s action is repeated by others as a way to increase transparency and gain public trust.

“My hope is that this catches on. That this serves as a catalyst,” Krumholz said. “My hope is that this can restore public trust in these companies.”

In addition to giving access to its data, Medtronic agreed with Yale to develop a new program that would publish Infuse data on a website for use by researchers.

 

James Walsh • 612-673-7428

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