Medtronic Infuse Bone Graft: Is Paying Doctors a Conflict of Interest?

Washington, DCThe emerging concern over Medtronic's Infuse Bone Graft, and the various adverse reaction reports that seem to be increasing, raises questions as to whether or not Medtronic's relationship with doctors paid by the company to lecture about the product, could be interpreted as off-label promotion.

The latter is illegal. While a doctor has complete authority to prescribe drugs, and medical devices for off-label use (uses for which they were not originally intended, or approved), the manufacturer is bound by the uses for which the product was approved by the US Food and Drug Administration (FDA).

However, drug companies and medical device manufacturers appear to have found a way around this restriction, and the Medtronic allegation is but the latest example.

But first, a bit about the Medtronic Infuse Bone Graft, a device that serves as scaffolding, if you will, for the growth of new bone tissue. The Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), which is a protein that is found naturally in the human body. The Infuse Bone Graft has proven useful for the treatment of Degenerative Disc Disease (DDD) and open tibia fractures, and was also approved for use in dental bone grafting procedures relating to sinus augmentation and localized alveolar ridge augmentation.

Concern first surfaced earlier this summer when the FDA warned, back in July, that Infuse had been used off-label for cervical spine surgeries, which treat injuries to the neck. Roughly 38 reports referenced unwanted bone growth that fostered swelling of the neck, which compressed the airway and caused patients to have trouble breathing, swallowing, even speaking. It has been reported that several required tracheotomies and feeding tubes.

It seems, however, that the off-label use of the Medtronic Infuse Bone Graft doesn't end there. In a recent expose by the Wall Street Journal, it was learned that potentially many more patients have been compromised by the off-label use of the Bone Graft, generating even more reports of bone growing where it shouldn't be, within close proximity to nerves or outside the targeted fusion areas. The results can be traumatizing, often resulting in severe pain and repeat surgeries and, in some cases, emergency medical intervention.

And while the FDA reported 38 adverse reactions in July, the Wall Street Journal cited about 200—with roughly 75 percent of those attributed to off-label use.

Is the manufacturer directly promoting these uses to doctors? Absolutely not. Too many manufacturers have had their knuckles rapped for engaging in such an illegal activity.

However, it seems that it's okay to pay a doctor—handsomely—to speak about your product to their colleagues.

This is nothing new. Drug companies and medical products manufacturers have been at this for years, and so far the FDA has made no effort to stop the practice. Surgeons and physicians are educated as to the benefits and risk profiles of a certain product, and then are invited to share their newfound knowledge with their colleagues in their free time. The thought is that doctors can, and do respond better to their colleagues, than a sample-carrying account executive directly employed by the company. And if a doctor is speaking freely, he or she can certainly reference off-label use of the product.

However, is this a conflict of interest? In Medtronic's case, the company allegedly paid 'consulting fees' to some of the most influential spine surgeons in the nation, and it has also been reported that some of these same doctors may have benefited from a royalty paid in conjunction with sales of the products in question.

It's interesting to note that prior to the approval of Infuse in 2002, the FDA was concerned about the potential for off-label use. However, a noted surgeon with the Emory University Orthopedics & Spine Center testified at an FDA advisory committee dealing with the issue that off-label use shouldn't even be discussed. According to the Wall Street Journal report Dr. Scott Boden told the panel that off-label use was "outside the scope of what we ought to be focusing on today."

At the time he testified, according to the Journal report, Dr. Boden was on the payroll at Medtronic to the tune of over $100,000 per year. That was in 2002. It has been reported that those payments continued through 2006, when the Journal reports that he received at least $75,000 from the company.

It has also been reported that in 2003, just after the Infuse Bone Graft was approved by the FDA in spite of off-label reservations, four surgeons penned a glowing report in Website Spine Universe with regard to the use of Infuse Bone Graft in the neck area, a use that was not approved by the FDA.

It has since been found, according to the Journal report, that three of the four authors had financial ties to Medtronic. In other words, they were being paid. Nowhere in the article was reference made to disclosure.

Thus, the question remains—do companies like Medtronic circumvent the off-label-marketing bugaboo by paying doctors to do their marketing for them? Is it legal? Is it ethical? Is it a conflict of interest?

These are questions currently under discussion in the courts of law. Two, of three whistleblower lawsuits alleging that Medtronic paid doctors to use Infuse Bone Graft, as well as other products, were settled for $40 million.

Medtronic admitted no wrongdoing.