Tag Archive | conflict of interest

How “Conflicted” Are Medical Journal Editors?

Open Payments Logo for OBuzzMedical journal editors wield substantial power in deciding what gets published and potentially implemented in clinical practice. Theoretically, those decisions could be influenced by “commercial” relationships. To help ascertain the extent of such relationships, a recent retrospective observational study in the BMJ examined payments by US pharmaceutical and device manufacturers to 713 editors from 52 influential medical journals in 26 specialties, including orthopaedics.

Using data from the Open Payments database from 2014 and information gleaned from a survey of journal editors-in-chief, Liu et al. discovered the following:

  • Among 713 editors, 50.6% received some “general payments” (i.e, money deposited directly into personal bank accounts) from pharmaceutical or medical device manufacturers in 2014.
  • The median general payment to journal editors was $11, while the mean general payment was $28,136.
  • The highest median payments were found among journal editors in the specialties of endocrinology ($7,207), cardiology ($2,664), gastroenterology ($696), rheumatology ($515), and urology ($480). The median payment among orthopaedics editors was $121.
  • The two highest payments to individual editors were >$1 million, and those editors were in the specialties of cardiology and—you guessed it—orthopaedics.

Beyond the dollar-and-cents data, the authors discovered that only one-third of the 52 journal websites had readily accessible statements of conflict-of-interest (COI) polices. Among the journals with COI policies, 75% said they have formal recusal processes that exclude an editor from handling manuscripts where he/she has a conflict.

According to an accompanying appendix, among the 34 JBJS editors included in the analysis (i.e., the US-based editor-in-chief, deputy editors, and associate editors), six had received general payments >$50,000 in 2014. The JBJS COI statement asserts that if conflicts are disclosed that might affect an editor’s ability to adjudicate a manuscript fairly, “the paper will be reassigned to another editor.” It also states that “the Editor-in-Chief has no known conflicts of interests or competing interests and makes the final decision regarding acceptance or rejection of all manuscripts submitted.”

Guest Post: Will Rep-Less ORs Improve Surgical Consistency?

OrthoBuzz occasionally receives posts from guest bloggers. The following commentary comes from David Kovacevic, MD in response to a November 14, 2016 article in The Washington Post.

Sandra G. Boodman’s recent column in The Washington Post, ”Why is that salesman in the operating room?… sheds light on the potential for conflicts of interest and other possible pitfalls of having device reps in the OR.  Currently, device reps are required to abide by the ethical standards set forth by AdvaMed, a medical device trade association. In addition, the American Academy of Orthopaedic Surgeons has adopted standards of professionalism regarding orthopaedist-industry conflicts of interest.

Both device rep and surgeon should have one common goal—to do what is in the best interest of the patient. Ultimately, though, the surgeon is responsible for patient welfare and safety.  This includes thorough pre-surgical planning; expertise in surgical anatomy, approach, and technique; complete knowledge about surgical instrumentation and implantable devices; and total transparency in the doctor-patient relationship.  The competent surgeon also manages the surgical team, collaborates with the anesthesia team, and recognizes the device rep’s adjunct role.

The presence of device reps in the operating room should be limited to answering implant-specific questions for the surgical team.  Patient-care problems can arise when the surgical team leader (i.e., the attending surgeon) and surgical team rely too heavily on device reps for technical expertise and assistance.  This can lead to questions as to who really is in charge and accountable.

Several solutions exist for sidestepping such ambiguity.  The consent-for-surgery form should state explicitly that a device rep may be present in the procedure room, and the device rep should wear scrubs or a disposable head cover that is a different color from the OR attire worn by surgical and anesthesia teams. The most effective solution, though, lies in building, developing, and sustaining surgical teams focused on improving operating room efficiency and consistency.  That’s a large undertaking, and the culture change needed for it requires buy-in from multiple stakeholders, such as the medical director of perioperative services, departments in the supply chain, and leaders in anesthesia, surgery, and nursing.

One rationale for a rep-less model is to reduce the cost of implants by working directly with and purchasing from the implant manufacturer and bypassing the group purchasing organization, sales reps, and distributors.  As Boodman’s article explains, for Loma Linda University Medical Center this meant obtaining device inventory directly from the implant manufacturer and training one of its surgical technicians as a de facto rep. The result was at least a 54% reduction in total case costs for primary total hip and total knee replacement procedures and empowering surgical technicians with additional knowledge about implants. It is too early to tell whether this model enhances consistency in the operating room, decreases operative time, or reduces length of stay and 30-day hospital readmission rates.

We should expect ongoing scrutiny of the device rep’s role in the operating room. With help from surgeons, hospitals and health systems should consider developing more effective surgical teams, including surgical techs specially trained about implants, to improve patient outcomes and consistency.

David Kovacevic, MD is associate fellowship director of shoulder and elbow surgery and assistant professor in the Department of Orthopaedics & Rehabilitation at Yale University School of Medicine. He can be reached at david.kovacevic@yale.edu or @KovacevicMD.

 

JBJS Editor’s Choice—Achieving Incremental Progress in Spinal Deformity Correction

swiontkowski marc color

Orthopaedic surgical procedures to correct axial and appendicular skeletal deformities are usually dependent upon fixation devices, either external or internal or both. These devices are often developed through close collaboration with engineers who are generally employed by major manufacturing companies. After the devices successfully clear rigorous bench, in-vitro, and in-vivo testing, the standard initial presentation of clinical results is a case series.

All too often the initial report of results comes from a co-developer of the device, with inherent selection and detection bias that constitute what most readers would consider a conflict of interest. McCarthy and McCullough’s case series on five-year results with Shilla growth guidance in 33 children with early-onset scoliosis in the October 7, 2015 JBJS is an exception to that rule. The authors report every conceivable major and minor adverse event without holding back any negative information. They categorize complications as infection secondary to wound breakdown, spinal alignment issues, and implant issues. The overall complication rate was 73%, a rate that is not surprising given the fact that the device under study is designed to maintain correction of spinal deformity in growing children.

Thankfully, the authors reported no neurologic complications. Also on the positive side, they found that spinal curves averaging 69° preoperatively averaged 38.4° at the most recent follow-up or prior to definitive spinal instrumentation. McCarthy and McCullough also calculated a 73% reduction in the number of surgical procedures among their cohort, relative to what would be necessary to treat the same population with distraction methods every six months.

I applaud the authors for comprehensively reporting the results of correction of spinal deformity in this difficult clinical situation with high accuracy and strict definitions of major and minor events. This is how we will make advances in correcting deformity for skeletally mature and immature patients—with innovation, incremental improvement, and the widespread sharing of adverse events with the orthopaedic community. Armed with the information from this study, we must now see what the number and severity of complications look like when the broader community of orthopaedic surgeons applies these devices.

Marc Swiontkowski, MD

JBJS Editor-in-Chief