A Need for Change

Shocked, disturbed, and embarrassed describe my feelings after reading an article titled “Medtronic Surgeons Held Back, Study Says,” published in the Wall Street Journal (WSJ) on June 29, 2011.³ This article reviews the findings that Dr Eugene Carragee and colleagues reported in The Spine Journal concerning 13 articles previously published on the use of the Medtronics, Inc. bone growth stimulant (BMP-2) products Infuse and Amplify.² The June 2011 issue of The Spine Journal focuses on the controversy surrounding the clinical investigation of these products.^1,2

In 2009, Medtronics generated $3.5 billion for spinal implants, making it the worldwide leader in the industry.⁴ According to the WSJ, 15 surgeons collectively received at least $62 million over the past 10 years for Medtronics-related work. According to Dr Carragee et al, who reviewed the Food and Drug Administration data, serious complications such as sterility and infections occurred in 10% to 50% of patients who were treated with Infuse or Amplify in 13 clinical trials funded by Medtronic and conducted by these same physicians in the past decade.² Unbelievably, these complications were not fully reported in the peer-reviewed publications, and the ties between the surgeons and Medtronic were not fully disclosed. The worst complication appears to be a doubling of the cancer rate in patients who receive Amplify.⁷ The possible cancer link was discussed in 15 pages of a 68-page Food and Drug Administration summary on Amplify that was not mentioned in the 2009 Medtronic-sponsored paper.³ According to the WSJ, 3 of the spine surgeons involved in the Amplify trial together received at least $10 million in royalty and consulting payments from Medtronic since 2001.³ While collaboration between physicians and the medical industry is vitally important to advancing the care of patients, clearly, these particular arrangements lie on a “slippery slope.”

Ever since I read this WSJ article, I kept hoping there would be a published retraction and that the allegations would not be substantiated. To date, this hasn’t happened, and I fear that the information appears to be accurate, which brings me to the very tragic implications of the reports in the WSJ and The Spine Journal. The public has reason to distrust the medical community: there appears to be a very unholy relationship between some physicians and the medical industry. Clearly there is a need for change!

Because of the efforts of Senator Charles Grassley (R, Iowa) and the Senate Finance Committee, a new federal law mandates public disclosures of all industry-physician payments by 2013.⁶ My only question about this mandate is, why wait until then? Many companies (including Medtronic), to their credit, began disclosing these financial arrangements with physicians in June 2011.

It is of the highest importance that these disclosures are accurately reported in published articles as well. To address this issue, the American Academy of Orthopaedic Surgeons convened a committee to investigate the issue of financial disclosure in American orthopaedic journals. The committee recommended that orthopaedic journals use a conflicts of interest disclosure form created by the International Committee of Medical Journal Editors (ICMJE) as a common disclosure form.⁵ In February 2011, the orthopaedic journal editors group met during the American Academy of Orthopaedic Surgeons annual meeting in San Diego, California. Many orthopaedic journal editors agreed to adopt the form for their journals, including Sports Health, with the following:

Readers of articles published in medical journals are entitled to a full disclosure of all financial conflicts of interest of the authors of those articles. In the fall of 2010, after extensive study, the ICMJE, as a part of their “Uniform Requirements for Manuscripts Submitted to Biomedical Journals,” approved a form for disclosure of potential conflicts of interest. Over the past few months, this form has been adopted by many medical journals throughout the world. It is our hope that the use of this form will 1) clarify the reporting responsibilities of all authors, 2) facilitate the reporting process as a common form will be employed by all of the journals listed, and 3) lead to a fuller and clearer understanding of potential author conflicts of interest on the part of our readers.

The collaboration between clinician scientists and medical device and drug companies has improved the lives of incalculable numbers of people. These relationships are critical to the future of medicine, but they must be guided by the highest ethical standards. Investigators must be willing to state any real or perceived conflicts, and journal editors must demand it. Critical peer review and editorial stewardship are also vital components of this process.

While the spine fusion example above is egregious, and most of the disclosure and conflict problems we see have more to do with transparency than outright disregard for patient safety, there is still a need to strive for a more honest reporting of medical research. It is my hope that our efforts will yield more accurate, reliable, and truthful reporting in the orthopaedic medical literature.

—Edward M. Wojtys, MD
Editor-in-Chief