Conflicts of interest: Be transparent, but not embarrassed
During the recent National Football League playoffs, many sports fans were surprised to see that New Jersey Governor Chris Christie in the suite of Jerry Jones, billionaire businessman and owner of the Dallas Cowboys. Christie enjoyed these all-expenses paid trips due Jones, with both later commenting that the governor has been a lifelong Cowboy’s fan.
The story does not end with the “feel-good” emotions that a lifelong fan was able to attend these games. The story is more complex, with a multitude of conflicts of interest that have been questioned by reporters.
Jones has many business ventures, including opportunities related to New Jersey. Recently, a Port Authority contract was given to a firm owned in part by Jones. The deal includes running the concessions at World Trade Center 1. Gov. Andrew Cuomo of New York and Christie issued a press release calling on the Port Authority Commissioners to approve the agreement, which they did. However, Christie and Cuomo appointed the Port Authority board. The deal provides tax subsidies to the National Football League which will save millions of dollars — far more than it cost to pay for Christie’s football weekends. Christie has argued the football weekends are permissible gifts because he passed an executive order that allowed him to accept gifts from personal friends.
This is not the first time Christie has been suspected of conflicts of interest. Documents obtained under the Open Public Records Act reveal Christie has traveled out of state more than 100 days last year primarily on trips difficult to clearly define as official state business. These trips have cost New Jersey almost $400,000 in travel expenses. The previous governor spent less than $22,000 during his final year in office. However, he was not priming for a potential presidential run.
Anthony A. Romeo
There have been numerous accusations regarding Christie’s failure to reveal conflicts of interest that directly affect his constituency in New Jersey. It is possible his knowledge of conflict of interest and federal anti-kickback laws has served him as a publicly elected official. He has avoided violation of the rules and has not been prosecuted, despite documented opinions that some behavior does not seem to be in the best interest of his constituency.
Conflicts of interest in orthopedics
As orthopedic surgeons, we have been bombarded by the concepts of conflict of interest for the past decade. In 2007, Christie, then a U.S. Attorney for New Jersey, filed criminal complaints against Zimmer, DePuy Orthopaedics, Biomet and Smith & Nephew, charging them with violating the federal anti-kickback statutes through their relationships with orthopedic surgeons. Of the “big five” orthopedic companies, only Stryker, which has headquarters in New Jersey, was exempted from the original criminal complaint, although they later made a deal with the Department of Justice.
Total fines of greater than $300 million were levied at the other four companies, and the relationship between industry and orthopedic surgeons was dramatically changed. As part of the court proceedings, the companies agreed to pay for outside attorneys and federal monitors to evaluate all future behavior related to surgeon relationships. All appointed monitors were awarded multimillion dollar contracts without any bidding process and all had personal relationships with the U.S. Attorney who initiated the process.
On the positive side, the leaders in the orthopedic profession have made an effort to define the concept of conflict of interest that can exist in consulting fees, royalties from products developed with surgeons, intellectual property contributions, paid speaker fees and honoraria, board membership for journals and orthopedic societies. The American Academy of Orthopedic Surgeons (AAOS) has a public website where members disclose and update their conflicts of interest. The goal of this disclosure is not to discourage the healthy aspects of the relationships that promote education, innovation and appropriate remuneration for intellectual property, but to be transparent with potential conflicts so others are able to better understand potential biases.
In 2012, the American Orthopaedic Association Task Force on Surgeon-Industry relationships stated: “The obligation of every physician is to put the best interest of the patient above all other considerations.” The leadership recognizes that surgeon involvement with industry has an important value with regard to implant design, instrument development and surgical technique that is unique among medical specialties. There are numerous examples where companies and non-surgeon employees have developed implants, instruments and suggested techniques that eventually fail because they did not have the insight to understand how the surgeons’ mind and hands work in the operating room.
Most of the greatest advances in orthopedic products have been in partnership between surgeon innovators and industry. This has driven the U.S. market to more than $30 billion in sales per year. Due to advances in technology within and outside the field of orthopedics, the average life cycle of many products is less than 10 years and requires continued efforts by companies and surgeon partners to innovate new and ideally better products. Surgeons and industry should not be prohibited from forming partnerships and appropriately rewarding intellectual property, which includes the ability to communicate with and educate peers thereby continuing to promote innovation, as well as product and instrument design.
The challenge is to avoid and eliminate relationships where industry is paying for the surgeon to use their device, or using the surgeon to promote products inappropriately through false or unsubstantiated claims and faulty research. These inappropriate relationships, which unfortunately still exist despite increased scrutiny, undermine the trust orthopedic surgeons have in their colleagues. However, it is even more damaging and it challenges patients’ beliefs that we do all we can to act in patients’ best interests above all other relationships. At this time, research has shown 15% of patients would be less likely to have their surgeon operate on them if they had an industry relationship that is a conflict of interest. So for now, public trust is strong that our behavior remains in their best interests.
We can define a potential conflict of interest whenever there is a professional judgment that has a reasonable chance of being influenced by the surgeon’s other interests. This can be a personal violation when it enters into the physician-patient relationship. When this affects how we present information to colleagues or the public — either through speech or publication — the violation may be less personal but even more influential. Therefore, it is important we are transparent with potential conflicts of interest and disclose these relationships to the audience or readership.
While financial conflicts have been the primary focus of defining conflict of interest policy, other conflicts include the integrity of research, desire for recognition of personal achievement or promotion, and unique opportunities for family and friends though relationships separate from that of the physician-patient relationship.
Our obligation as orthopedic surgeons is to put the best interest of our patients above all other considerations. This includes every patient we see in the office and operating room, as well as other patients we can impact with presentations, publications and educational activities.
We need to be transparent with potential conflicts of interest, including our commitment to the AAOS disclosure program as well as disclosures in all public activities, including patient care. However, we should not be embarrassed that our contributions and intellectual property have financial benefits. There is incredible value in innovation, education and research, which is truly in the best interest of patients. We hope our elected officials will follow a similar path and behave in the best interest of the people they serve.
For more information:
Anthony A. Romeo, MD, is the Chief Medical Editor of Orthopedics Today. He can be reached at Orthopedics Today, 6900 Grove Rd., Thorofare, NJ 08086; email: firstname.lastname@example.org.
Disclosure: Romeo receives royalties, is on the speakers bureau and a consultant for Arthrex Inc.; does contracted research for Arthrex Inc. and DJO Surgical; receives institutional grants from AANA and MLB; and receives institutional research support from Arthrex Inc., Ossur, Smith & Nephew, ConMed Linvatec, Athletico and Miomed.