by Michael H. Heggeness, MD, PhD, NASS President

Professional ethics is much in the news today, and appropriately so.  In my heart and in my mind, I strongly believe that the overwhelming majority of spine practitioners conduct themselves—and their practices—to  deliver appropriate, ethical and compassionate patient care.  Unfortunately, our profession does occasionally come under scrutiny because of ethical issues.

Over the last several years, NASS has embraced the importance of ethics and professionalism in our societies’ educational and other activities. As we have come to understand the complex science behind  conflict of interest, unintended bias and transparency, many more changes have come about. The history and intent of these changes are important to understand.

This is NOT an attempt by our society to declare that we are more honest, more moral or somehow superior.  It is also NOT an assault on the spine care industry. Our ability to care for our patients depends heavily on the products and services that industry provides. Industry depends on physician collaboration for scientific advancement. Without our friends in the commercial arena, innovation and progress would be severely stifled.

Instead, we are seeing an evolution of processes governing the society’s activities of the society. The changes will protect us from unintended harm to the trust of our patients. This process allows us to educate ourselves to best avoid unintended ethical lapses. These changes help insure that as participants in NASS’ various activities such as education, research and advocacy, we are as transparent as possible. We also seek to manage such conflicts in consistent and reasonable ways.

I am very pleased to remind us all of the NASS mission statement:

NASS is a multidisciplinary medical organization dedicated to fostering the highest quality, ethical, value-based and evidence-based spine care through education, research and advocacy.

Yes, ethics is appropriately very much a part of our mission.  How did all of this come about?

Stanley A. Herring, MD, initially made ethics a high priority for the society during his NASS presidency, over a decade ago.  His presidential address at the 2002 annual meeting, “A Plea for Professional Behavior,” eloquently drew our attention to this issue.1  During Dr. Herring’s presidency, NASS established an Ethics Task Force (now a permanent committee) to help establish policy, as well as a Professional Conduct and Ethics Committee (the PCEC) to evaluate members’ conflicts or complaints. Time has shown us that both committees were important, although I am pleased to report that thankfully, the PCEC has not been extremely busy. In 2002, the Board of Directors adopted a new code of ethics, as well as Expert Witness Guidelines (See these and other NASS policies related to professionalism).

At the 2005 Annual Meeting, Past President David Fardon, MD, chairing an interactive symposium on “Ethics in Spinal Medicine and Surgery” revealed our need for ethics education. While virtually all spine care practitioners wish to practice the best quality and the most ethical medicine possible, many are unaware of how numerous “outside issues” influence our decision-making process.  To enhance our education in this arena, Ethics presentations remained on NASS’ Annual Meeting programs. Recently, Sohail Mirza, MD, offered a very insightful presentation exploring the moral, legal and ethical implications of physician relationships with industry entitled, “The Science of Bias.” To give additional viewpoints on the issue, the Ethics Committee included lawyers, the Department of Justice and major industry representatives in subsequent panels.

The 2007 symposium was particularly revealing.  Chaired by Dr. Herring and Dr. Richard Guyer, the presentation provided attendees with scenarios portraying various physician-industry interactions. Those attending were asked to judge whether each interaction was legal and then—a higher bar—ethical. After audience responses were tabulated, Peter Winn from the Department of Justice gave his viewpoint.  Some audience members were very surprised that many of the relationships they assumed were not only legal, but also ethical, did not even meet the bar for legality. This symposia was presented two years in a row (with slight variations, but the questions remained the same). The second year’s audience response showed an increase in NASS members’ overall awareness of ethical issues.

We believe that disclosure of possible financial conflicts in NASS meetings and in other NASS activities are important. As a society, we realized that all individuals involved in NASS programs should declare any financial conflict of interest.

NASS’ 2006 Disclosure Policy required individuals with financial conflicts to disclose and identify them as “minor” or “major” if they were over or under an annual value of $10,000 (a threshold based on a widely used guideline originated at the Mayo Clinic).

Obviously, in our field, consultants and inventors are sometimes remunerated at values many orders of magnitude higher. It seemed appropriate to NASS leadership that attendees and other participants in scientific or educational activities should be better informed of the amounts of money involved in the relationship a speaker might have with a company or other entity.  Due in large part to the talent, hard work and wisdom of Board members Marjorie Eskay-Auerbach, MD and Jerome Schofferman, MD, NASS adopted our present Disclosure Policy in 2009.

Expanding beyond “minor” and “major” reporting, our present disclosure module details financial relationships ranging from $100 to $2.5 million plus. NASS volunteers and staff expended a great deal of effort, not simply to define the details of the information required, but to bring the policy into active use. We created a software system, in fact, to collect and tabulate this varied and complex information on a scale as large as that of our annual meeting. NASS’ staff talent allowed us to pull it off.

Since then, any participant at a NASS function can access the information he or she needs to judge any speaker’s potential for bias. Presenting this information in no way casts a judgment on such activities; We recognize that without teamwork between spine care practitioners and industry, it is difficult to advance the field. We simply believe that the audience member should have the ability to make a fully informed opinion about the potential bias in the information being presented.

Disclosure is an important part of the process of managing a potential financial conflict of interest.  Can we go further?  Yes, we can, and in fact, we did.

It is fairly obvious that managing conflicts of interest is easier if fewer possible conflicts exist. Many NASS members do not know that the NASS Board of Directors has taken an additional giant step. In 2009, the NASS Board approved a stringent policy for individuals in leadership positions in NASS, including all Board members, and certain other key positions within the organization.  The policy forbids Board members from entering into consulting relationships, speakers’ bureaus and almost all paid roles with industry.  Some exceptions are made for royalty payments for inventors and some other relationships with nonprofit entities. However, all such relationships are subject to review by the Conflict of Interest Review Panel (COIRP). Please know that the Board of this wonderful society followed through with this policy with no board members choosing to resign.  Indeed, while many Board members had no such financial relationships to disclose or divest, several Board members (yes, myself included) divested themselves from one or more relationships.

In closing, I do not wish to be misunderstood.  We who are lucky enough to make practicing spine care our profession greatly value our industry colleagues.  Indeed we could not do what we do without them.  They support our efforts in countless ways beyond providing high quality products for our patients; their support includes research, innovation, grants and sponsorships.

Sadly, our federal government has little or no interest in funding meaningful research on spinal disorders, or indeed in funding the study of most of the musculoskeletal system.  I will be writing more about this shameful situation in a future column.  Clearly, without industry there would be little, if any, innovation at all.  We truly value our industry partners.  All that we are hoping to accomplish is to acknowledge and manage the potential conflicts that inevitably arise from these relationships. We cannot and will not lose the public trust and, therefore, must be transparent and consistent in how we conduct ourselves and our practice of medicine.

Thank you for reading this column.  I received significant help from NASS’ Executive Director, Eric Muehlbauer, and NASS’ Director of Ethics, Laura Sawyer, in putting this essay together. Feedback is always welcome.

Reference

1. Herring SA. A plea for professional behavior: North American Spine Society presidential address, Montreal, Canada, 2002. Spine J. 2002;3(1):5-9.