The controversy surrounding Medtronic Inc.’s Infuse Bone Graft product has sparked reforms that some experts say could bring greater transparency and credibility to the development of new medical devices and drugs. According to a report from the Milwaukee Journal-Sentinel, Medtronic’s Infuse woes are partly responsible for new policies instituted at medical journals that require researchers to provide detailed disclosures of financial data and study methods in the articles they publish.
Infuse is made from a genetically engineered material called rhBMP-2 (recombinant human Bone Morphogenetic Protein-2), which stimulates bone growth. Infuse was approved by the U.S. Food and Drug Administration (FDA) for use in one type of spine surgery called anterior approach lumbar fusion. Later, it was approved for use in two types of dental surgeries. However, it’s long been recognized that Infuse is frequently used in procedures not approved by the FDA. In 2008, the agency warned that Infuse and similar rhBMP-2 products had caused serious problems when they were used off-label in cervical spine (neck) surgeries.
When Infuse first came on the market in 2002, rhBMP-2 was expected to revolutionize medicine, supposedly offering 100 percent success in fusing ailing spines with virtually no complications, the Journal-Sentinel said. But since its approval, Infuse has become embroiled in one controversy after another. Just this past summer, Dr. Eugene Carragee published an article in The Spine Journal asserting that Medtronic-paid surgeons had failed to report serious complications from rhBMP-2, including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain. The article said complications occurred in 10 to 50 percent of patients who got the product in 13 Medtronic-funded clinical trials between 2000 and 2010.
Carragee’s review, which appeared in an issue of the journal devoted entirely to debunking rhBMP-2 research, also examined payment data from Medtronic to doctors who co-authored the Infuse studies, and found that, the median amount to the company paid to doctors was at least $12 million to $16 million per study (though it should be noted that none of the royalty payments related to Infuse). A Milwaukee Journal Sentinel/MedPage Today investigation found that those payments were rarely disclosed in published articles. What’s more, research touting the supposed benefits of rhBMP-2 has influenced medical practice, as spine surgeons have become increasingly aggressive over the years in their treatment of common back problems without adequate evidence that it actually benefits patients.
But now it seems some medical journals are changing their policies in response to research scandals involving rhBMP-2 and other medical products. In February, for example, the editors of 17 orthopedic journals agreed to adopt a standard conflict of interest disclosure form for authors. The Spine Journal is also changing its policy so that study funding and the financial relationships of authors will be spelled out in ranges within the body of the article in the methods section, the Journal-Sentinel said. Articles published in The Spine Journal will also include information on who paid for the study. Penalties for failing to disclose that information could include the retraction of the paper and possible barring of future submission.
According to the Journal-Sentinel, some doctors and reformers now are calling for a new system in which independent groups would be hired by medical companies to conduct clinical trials and publish the data. This, it is hoped, would create a “fire wall” between companies that fund clinical trials and what happens to all the data that is generated.