The New York Times said the most recent issue of the Spine Journal “represents a watershed in the long-running debate over conflicts of interest for the sponsorship of scientific studies by makers of drugs and medical devices.”
As the Times notes, scientific disagreements like this one are rarely debated in public.
Dr. Christopher M. Bono Chief of the Spine Service at Brigham & Women’s Hospital, is the editor of the journal. In this guest post, he explains the process that led to the strongly worded statement regarding the integrity of both industry-funded scientists and the journals that publish their work.
Complications and Adverse Events with rhBMP-2: A Lesson on the Peer-Review Process -Christopher M. Bono, MD
The June issue of The Spine Journal, the official journal of the North American Spine Society, was dedicated to the subject of bone-morphogenic protein (BMP) use in the spine. Among the various excellent papers in this issue, two stand out in that they strongly suggest that previously reported complication and adverse event rates with use of BMP in the spine were underreported. In one of the highlight articles, authored by Eugene Carragee et al (and regular Editor-in-Chief), an analysis of summary FDA trial data and other non-industry sponsored papers demonstrated 10 to 50 times more complications than reported in the peer-reviewed publications of industry-sponsored pilot and pivotal trials of BMP-2 use in the spine. As acting Editor-in-Chief of the June focus issue, I had the responsibility of guiding these landmark papers through the peer-review process and ultimately making the final decision to accept them for publication. With that decision, and the proximate decision that Dr. Carragee and his co-authors’ made to perform the analysis, the subsequent events and turmoil within the medical publishing world were certainly anticipated.
There was somewhat of a compulsion, if not a requirement, to publish these data in The Spine Journal. The editorial board was made aware of growing concerns of the safety and complications with BMP. Within these concerns were intimations that the adverse event rates published in the pivotal trials were underestimated and that the journals in which these pivotal trials were published (The Spine Journal included, though under a different Editor-in-Chief at the time) had a responsibility to investigate the validity of these concerns. Holding patients’ safety and outcomes as our brightest beacon, we felt it was our obligation to make the findings public and accessible. In effect, the decision to publish the BMP focus issue was as much a criticism of us (as editors of a well-respected spine journal) as it was of the potentially conflicted study authors or any particular manufacturer.
Despite our strong feeling that this was the right thing to do, we understood that publishing these reviews would stir tremendous controversy and potentially strong criticism from colleagues. The original authors of many of the BMP trials are highly respected in the field of spine surgery and have published many other excellent studies. Importantly, it was not our goal or intention to discredit any individual, product, or manufacturer. In contrast, it was to underscore that: (1) financial relationships with a company or manufacturer need to be clearly and completely disclosed in any publication and (2) the potential exists for the influence of compensation from a manufacturer (even if not specifically for the exact product in question) on the interpretation and presentation of study data.