In 2002, Thomas Zdeblick, a University of Wisconsin orthopedic surgeon who has pocketed millions of dollars in royalties from the spinal device maker Medtronic, took over as editor-in-chief of a medical journal about spinal disorders.
It would be the beginning of a beautiful friendship.
In the years to come, Zdeblick would receive more than $20 million in patent royalties from Medtronic for spinal implants sold by the company. And the medical journal he edited would become a conduit for positive research articles involving Medtronic spinal products, a Journal Sentinel analysis found.
Zdeblick took over editorship of the Journal of Spinal Disorders & Techniques seven years ago. Since then, studies involving Medtronic spinal products or that were funded by Medtronic appeared in the journal at least once per issue, on average.
Dozens of studies that mentioned Medtronic products have been published while Zdeblick has been editor. But in issue after issue, readers of the journal were not told that he was receiving millions of dollars in royalty payments from Medtronic at the same time.
Most of the time the articles, including some co-authored by Zdeblick himself about devices for which he gets royalties, had good things to say about the Medtronic products. Only on a small number of occasions did the articles find major problems with Medtronic devices.
And often the articles did not disclose financial ties the authors had to Medtronic.
Here are some specifics:
From 2003 through 2007, Zdeblick got more than $19 million in royalty payments for spinal devices from Medtronic, according to a January 2009 letter by U.S. Sen. Charles Grassley (R-Iowa), who has been investigating payments to orthopedic surgeons by Medtronic. In 2008, Zdeblick got another $2 million from Medtronic from royalties and working as a consultant, according to UW records.
To assess the relationship, the Journal Sentinel reviewed every article published in the journal since Zdeblick became editor.
The journal is published seven or eight times a year and typically has a dozen or so articles. The articles were searched to see if Medtronic products were used as a part of the study or if the study was funded by Medtronic.
At least 70 such articles were found in 56 issues of the journal from 2002 through October 2009.
• A 2005 study by researchers in France found favorable preliminary results with Medtronic's Maverick artificial disc.
In 2007, Medtronic paid Zdeblick $144,000 in royalties for the Maverick disc, according to Grassley's letter.
• In August 2009, Zdeblick co-authored a study that involved Medtronic's 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.
• Zdeblick also co-authored three articles, in 2002, 2003 and 2005, involving Medtronic's BMP-2 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.
Often articles in the journal had good things to say about Medtronic products:
• In the 2002 study, Zdeblick and the co-authors concluded that BMP-2 and the LT-Cage led to a solid union and high fusion rates. In the 2003 study they found that BMP-2 may become 'the new gold standard.'
• In a 2006 study, a different group of authors concluded that BMP-2 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.'
Dr Zdelblick declined to comment for the Journal-Sentinel, but:
In a statement, a spokesman for the spinal journal said Zdeblick has disclosed his financial relationship with Medtronic to the company that publishes the journal, Wolters Kluwer Health/Lippincott Williams & Wilkins.
All manuscripts submitted to the journal go through a rigorous review process using reviewers who have an objective viewpoint, Robert Dekker, director of communications with Philadelphia-based Wolters Kluwer Health & Pharma Solutions, said in a statement. 'Thanks to our strict peer review policies and processes, we have no concerns about the existence of this relationship,' Dekker said in an e-mail.
Dekker declined to provide a list of the reviewers used by the journal or information about their financial relationships with device companies. He also declined to comment on how Zdeblick made decisions about manuscripts and reviewers.
Of course, as the Journal-Sentinel pointed out, editors can make publication decisions independent of the recommendations of peer-reviewers. They also are free to select peer-reviewers who might have a particular viewpoint about a manuscript, its topic or authors, and to make and enforce editorial suggestions for changes in manuscripts. It is beyond me what good that disclosure of conflicts of interest to a for-profit publishing corporation does in the absence of further disclosure. Keep in mind also that the division of Wolters Kluwer that publishes the journals, Wolters Kluwer Health & Pharma Solutions, not only publishes journals and textbooks, but "provides marketing and publications services, business intelligence products, and advanced analytical tools and services" to pharmaceutical corporations.
Furthermore,
'It's absolutely a conflict,' said Richard Smith, the former editor of the British Medical Journal.
At a minimum, Zdeblick's conflict should be fully disclosed by his journal whenever a study involving a Medtronic product is published, said Smith, the author of 'The Trouble with Medical Journals.'
However, because he makes so much money from Medtronic royalties, he really should not be editing the journal at all, Smith said.
Just to add icing to the cake, Prof Margaret Soltan pointed out on her University Diaries blog that Dr Zdeblick is not only a journal editor, but a Professor and Chairman of Orthopedics and Rehabilitation at the University of Wisconsin. In addition, his web-page at the University notes that he is on the editorial board of another orthopedics journal, Spine, also published by Wolters Kluwer Health.
So here we go again. How should we assess the objectivity of an ostensibly scholarly medical journal whose editor was made rich by royalties from a company whose devices were often evaluated in the articles published in the journal? How should we assess the honesty of a journal editor who received millions in royalties from Medtronic, but who only deigned to disclose as an author in his own journal, "One or more of the author(s) has/have received or will receive benefits, (e.g., royalties, stocks, stock options, decision making position) for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript." (as in Zdelblick TA, Phillips FM. Interbody cage devices. Spine 2003; 28: S2-S7.) (Note that this sort of disclosure seems to be standard operating procedure for orthopedic surgeons who make millions from royalties and consulting fees, e.g. see this post.)
Prof Zdelblick had numerous opportunities to influence his colleagues, trainees, and students in his roles as journal editor, journal editorial board member, author of scholarly articles, and professor and chair of orthopedics. At the very least, the people who read his journal or his articles, listened to his lectures, or participated in his clinical teaching should have at least had the opportunity to judge for themselves whether being paid over $20 million might have just biased what he wrote and said a tiny bit. But can anyone doubt that $20 million dollars would profoundly influence one's thinking? Can anyone doubt that an inventor who got rich from royalties might not be more enthused about the use of the devicesthat generated the royalties than would an academic whose salary is unrelated to the use of any device? It seems to be an abuse of entrusted power for a journal editor, professor, and department chairman not to clearly disclose such huge conflicts of interests to readers, learners and colleagues.
This is just the latest vivid example of the conflicts of interest that permeate health care. When multi-million dollar men pretend to be unbiased editors and professors, is it any wonder that we regularly overuse and overvalue the devices and drugs that they are selling?
ADDENDUM (6 January, 2010) - See also comments on the Spine Blogger, and by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.
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