As the fallout from a conflict-of-interest scandal continues, drug maker Medtronic, announced in its fiscal fourth-quarter earnings report that the results from a long-awaited Yale review are expected to be published next month.
Medtronic has been the focus of a conflict-of-interest scandal following the release of a government report that revealed that none of 13 Medtronic-funded clinical trials reported Infuse® side effects. Meanwhile, data provided to federal regulators revealed that at least half of the patients who were treated with Infuse® suffered complications.
In June 2011, a U.S. Senate Finance Committee inquiry probed surgeons who received payment from Medtronic but who had not reported Infuse®-related complications in their data. Medtronic Infuse® was approved by the U.S. Food & Drug Administration (FDA) in 2002 and stimulates spine growth in patients who suffer from lower spinal degenerative disease. A synthetic form of recombinant human Bone Morphogenetic Protein (rhBMP-2), Infuse® is approved for use in one type of spinal surgery and some dental procedures; however, the product is used, for the most part, in off-label procedures.
Infuse’s® approval was based on Medtronic-funded research. The studies presented Infuse® as a major breakthrough in spine surgery; however, the significantly manipulated information downplayed serious complications associated with Infuse® and overstated the benefits of bone growth product. A Senate report detailed how Medtronic employees, some from its marketing department, surreptitiously worked with academic physician authors on 11 papers produced between 2002 and 2009.
While this type of so-called “ghostwriting” is not illegal, it is largely considered a breach of integrity and lacking in transparency, placing doctors and patients in a position in which they must rely on incomplete, flawed data when determining important medical decisions, noted WebPage Today previously
The Spine Journal devoted a full issue in 2011 to proving the Infuse® research wrong. “This sounds eerily familiar to many of the transgressions we’ve read about from the pharmaceutical industry,” Dr. Harlan Krumholz, professor of medicine at Yale University, told MedPage Today when advised of the Senate report. “It paints a picture of a company very heavily involved in the science; marketing contaminating the science; and the medical profession and researchers being complicit. It’s no wonder the public has lost confidence in the drug and device industries,” Krumholz added.
A frequent critic of the product warned that the association between Infuse® and cancer might be stronger than originally thought. In a study recently presented at the North American Spine Society meeting, Dr. Eugene Carragee reported that his review of a Medtronic-funded study indicated that a higher-dose formulation of Infuse®, known as Amplify, had been linked to a significantly increased cases of cancers than were found among those who received a traditional bone graft. Amplify was actually rejected by the FDA because this association.
In fact, it was Carragee expose that prompted Medtronic to look to Yale University, and Dr. Harlan Krumholz, a doctor Forbes magazine once referred to as “the most powerful doctor you never heard of.” According to a report from the Minneapolis Star-Tribune, Krumholz and his team at Yale will address fundamental questions: Does Infuse® work? Is it safe? “I’m not seeking to address how the product was marketed,” Krumholz told the Star-Tribune. “I’m just sticking to the science. I’m trying to set in place a new way of doing business.”
While many experts acknowledge the unprecedented nature of the Yale project, even praising its scope, they have little praise for Medtronic’s handling of the Infuse® debacle. “I think it’s ridiculous that the company is saying it’s now going to complete an independent study [on Infuse],” Dr. Charles Rosen, a California spine surgeon and founder of the Association for Medical Ethics, told the Star-Tribune. “That implies the previous studies weren’t independent.”
Medtronic’s spine sales were flat overall at $811 million, according Health Point Capital, citing Medtronic’s recent earning’s call. CEO Omar Ishrak said that segments of Core Spine were “not only stabilizing but actually growing.” It is unclear if that growth is related to the Infuse® product.
Medtronic faces increased federal scrutiny and mounting legal pressure from the many recipients of Infuse®. In addition to manipulating safety data and misleading surgeons and would-be recipients of the product, Medtronic also actively promoted Infuse® for off-label purposes. This is significant because many recipients claim they were never warned of the dangers of Infuse® before it was used in their surgery and, as times goes by, they, along with federal regulators and company shareholders, are learning of the means by which Infuse® reached the market and bolstered the company’s bottom line.