Spine Doctors Mandated to Disclose Financial Ties to IndustryJan 1, 2009 | Parker Waichman LLP
Some doctors will be required to disclose their financial ties to medical device companies as well as the dollar amounts associated with those relationships, the Wall Street Journal (WSJ) reported.
At the urging of lawmakers and in response to lawsuits, the 5,000 member North American Spine Society (NASS) is requiring its researchers to make these financial disclosures, said the WSJ, when those researchers present studies at medical conferences. The Journal explained that some of these well-known surgeons have been involved in financial relationships in which large amounts—sometimes in the millions—were paid to them by industry.
NASS noted this requirement "is not a voluntary guideline, but a binding covenant which applies to all relationships engaged in by all participants in all" activities of the NASS and that not disclosing this information is a "sanctionable offense," Nass said, according to the WSJ. And while the sanctions would impact a doctor’s NASS standing, sanctions would not affect a physician’s ability to practice medicine, said the WSJ.
"It just became clear that more transparency is better," the spine society's ethics-committee chairwoman, an Arizona-based orthopedic surgeon, Marjorie Eskay-Auerbach, said, quoted the WSJ. Niether Eskay-Auerbach nor Catherine D. DeAngelis, editor in chief of the Journal of the American Medical Association, knew of other such policies in effect elsewhere. "I'm sure this is because of Senator [Chuck] Grassley" (Republican-Iowa), said DeAngelis. Grassley has publicized the millions of dollars industry has paid to some prominent physicians. "I'm sure they're saying we'd better police this ourselves or the feds will," DeAngelis said to the WSJ.
For instance, Medtronic Inc. paid a surgeon and researcher $19 million over five years to help Medtronic develop and promote it’s spine products, including the Infuse Bone Graft; according to an earlier WSJ report, the Medtronic payments received by University of Wisconsin researcher Dr. Thomas Zdeblick amounted to far more than he ever disclosed to the school.
In July, the U.S. Food and Drug Administration (FDA) warned that use of Infuse Bone Graft and similar devices caused serious problems when they were used off-label in cervical spine (neck) surgeries; the device is named in several lawsuits that claim Medtronic improperly promoted off-label use, and it is the subject of a Justice Department investigation. Medtronic has also been named in three “whistleblower” lawsuits filed by former employees that alleged the company paid doctors to use the Infuse Bone Graft and other Medtronic spine products. Medtronic agreed to pay $40 million to settle two of the cases, but admitted no wrongdoing.
The Medtronic Infuse Bone Graft is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. The Food & Drug Administration (FDA) has also approved it for use in two dental bone-grafting procedures: Sinus augmentation and localized alveolar ridge augmentation. The FDA has not approved this device for any other procedure and using it on the neck area, or operating from the back side, is considered off-label.