Medtronic, Infuse and the Senate Finance Committee

June 27th, 2011 | Sources: Commentary

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Spinal fusions jumped 1,500% among Medicare patients between 2002 and 2007. The explosion had nothing to do with changes in prevalence of the conditions for which the complex surgery is performed. It had everything to do with the release of Infuse, a bone growth stimulator that reduces the complexity of the procedure.

Infuse (pictured) is marketed by Medtronic. It was approved by the FDA in 2002, specifically for spinal fusions of the lumbar (lower) spine using a particular surgical technique: the frontal approach. Soon after the FDA green-light however, surgeons began using it for other kinds of lumbar fusions and cervical (neck) fusions as well. Peer-reviewed studies of these non-approved uses helped drive the explosion in spinal fusions. Now, remarkably, off-label use accounts for 85% of Infuse use. The biological garners nearly $900 million in annual revenues for Medtronic.

There’s More to the Story
Unfortunately, newer studies of spinal fusion have found it to be no more effective for common back pain than physical therapy. Use rates of Infuse have not responded to this growing literature.

Beyond this, the off-label use studies mentioned above were sponsored by Medtronic and led by scientists that received tens of millions of dollars’ worth of royalty payments and consulting fees from Medtronic. It has recently been alleged that these scientists knew about certain complications caused by Infuse, and either failed to disclose them or de-emphasized them in their write-ups.

The complications include some that are potentially fatal– neck swelling severe enough to compromise breathing, and possibly an increased cancer risk, for example. They also include sterility in men, a complication Medtronic and surgeons with financial ties to Medtronic appear to have been aware of—but did not report–since 2002.

These alleged shady behaviors came to light just recently, when researchers re-examined data from the Medtronic sponsored trials. The data was submitted to the FDA, but never made it into the literature that spawned widespread, off-label use of Infuse.

The matter has now escalated all the way to the Senate Finance Committee. In a letter to Medtronic last week, Committee members Max Baucus and Charles Grassley claimed that “doctors conducting clinical trials examining the safety and effectiveness of Infuse on behalf of Medtronic (knew that Infuse could) cause medical complications, but failed to report this in the medical literature.” The senators asked Medtronic to send them all documents and communications relevant to these studies, as well as a detailed account of payments made by Medtronic to all surgeons involved in the studies.

The run-in with Senate Finance is just the latest in a series the company has had with federal officials. In 2008, the Justice Department opened an investigation to determine whether the company illegally promoted off-label uses of Infuse. A year later, an Army investigation found that a former Army surgeon, paid by Medtronic, had falsified the results of a study involving Infuse. That’s not counting recently unsealed testimony given in a 2002 lawsuit filed by a former Medtronic lawyer which alleged that the company illegally gave surgeons incentives to use its products.

What Do We Make of This?
Senators Baucus and Grassley have turned harpooning the business practices of companies that profit from health care into an art form. They’re particularly adept at selecting issues that garner popular support. In this case, they argue that patients and physicians have a right to expect that the information on which they rely is accurate, unbiased and comprehensive. Applying that thesis to the Medtronic situation, the point is that when studies of drugs or devices are published by scientists with financial ties to the company that markets the product in question, this needs to be disclosed, even if the payments aren’t linked to the product being evaluated. We couldn’t agree more.

Then again, Senate Finance isn’t equipped to take-on more than a few of the many egregious spectacles in which health companies have recently become enmeshed. More potent lines of defense include the editors of peer reviewed journals, who need to re-evaluate their disclosure policies. They also include physicians, who must step to the plate more often in a watchdog role, alerting others in the profession about potentially unsavory behavior or previously unreported complications associated with drugs and devices. Finally, as Maggie Mahar points out, the mainstream media also plays a role by continuing to pursue the story of money-driven medicine.

“The repetition is crucial,” she said. “Education depends on repeating the same message, and making it clearer over time.”


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