The editor of The Journal of Spinal Disorders & Techniques has received millions in royalties for spinal implants from medical device maker Medtronic Inc. At the same time, the journal he edited regularly published positive research articles involving Medtronic spinal products, including its <"http://www.yourlawyer.com/topics/overview/Medtronic_Infuse_Bone_Graft">Infuse Bone Graft product.
According to The Milwaukee Journal-Sentinel, Thomas Zdeblick took over the editorship of the journal in 2002. Since then, the patent royalties Zdeblick received from Medtronic have amounted to more than $20 million.
The Journal-Sentinel’s analysis of articles published in The Journal of Spinal Disorders & Techniques found that during Zdeblick’s tenure, the publication became ” a conduit for positive research articles involving Medtronic spinal products.” All the while, it was never disclosed to readers that the journal’s editor was receiving payments from Medtronic.
The Journal-Sentinel’s investigation found least 70 such articles in 56 issues of the journal from 2002 through October 2009. These included
â€¢A 2005 study by researchers in France found favorable preliminary results with Medtronic’s Maverick artificial disc.â€‚
â€¢In 2007, Medtronic paid Zdeblick $144,000 in royalties for the Maverick disc, according to Grassley’s letter.
â€¢In August 2009, Zdeblick co-authored a study that involved Medtronic’sâ€‚ Premier Anterior Cervical Plate as well as the plate of another company, Synthes. The study involved using two different kinds of bone grafts with the plates. Zdeblick got $654,000 in Premier royalties from Medtronic in 2007.
â€¢Zdeblick also co-authored three articles, in 2002, 2003 and 2005,â€‚ involving Medtronic’s Infuse and the LT-Cage, a device that paid him $1.4 million in royalties in 2007. None of those studies disclosed that he received millions of dollars in royalties from Medtronic.
â€¢A 2002 study in which Zdeblick and the co-authors concluded that Infuseâ€‚ and the LT-Cage led to a solid union and high fusion rates. In the 2003 study they found that INFUSE may become “the new gold standard.”
â€¢A 2006 study where different group of authors concluded that Infuseâ€‚ when used with a hip bone graft significantly improved the success of the fusion surgery with minimal risk to the patient. The 2005 French study of Medtronic’s Maverick artificial disc that did not involve Zdeblick concluded it was a “promising therapeutic technique.”
According to the Journal-Sentinel, it was also not disclosed that many of the co-authors on these articles also had financial relationships with Medtronic.
Infuse Bone Graft is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.
In July 2008, the Food & Drug Administration (FDA) warned that the use of Infuse and similar products had caused serious problems when they were used off-label in cervical spine (neck) surgeries. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.
In an interview with the Journal-Sentinel, Charles Burton, vice president of the Association for Ethics in Spine Surgery, questioned the propriety of Zdeblick’s articles being published in his own journal. He likened Zdeblick’s editorship to “fox in charge of the chicken house.”
Likewise, Charles Rosen, head of the Association for Medical Ethics clinical professor of orthopedic surgery at the University of California, Irvine, School of Medicine questioned any notion that Zdeblick’s relationship with Medtronic would not influence his editorial decisions, telling the Journal-Sentinel that Zdeblick is “only human.” Of note, Rosen’s group advises that no one who serves on the editorial board of a journal receive more than $50,000 from a device or drug company.
According to Journal-Sentinel, Zdeblick declined to comment on its investigation. However, the director of communications with the company that publishes The Journal of Spinal Disorders & Techniques maintained that the journal’s “coverage of Medtronic products is in no way tied to or impacted by any separate relationship between the company and Dr. Thomas Zdeblick.”