Tuesday, January 29, 2013

Crossroads: The Intersection of Personal, Professional Society, and Industry Relationships by William H. Seitz Jr. and Edward Diao

Being hand surgeons who have been researchers, educators and clinicians, responsible for the education of medical students, residents, fellows and peers, who by necessity have worked with industry to develop new products, for which we have been compensated, we have always represented our involvement and potential conflicts in all of our professional activities. As such, we have been tapped over the past ten years by The American Society for Surgery of the Hand (ASSH) to develop and expand its relationships with industry to support our mission of education, research and innovation. This work was begun long before the investigation by the Department of Justice of improper personal relationships between orthopedists and industry.

We helped provide a peer–reviewed process for education and display of industry’s new technology at our annual meetings, which financially fueled our ability to enhance the quality of the meetings. This included the development of “hands–on” skilled workshops where industry provides surgeons opportunity to physically utilize new technology in a simulated surgical environment. The industry participants were charged a fee for this opportunities, and very quickly these opportunities became highly sought after by industry and significant revenues were generated. This provided feedback for industry from the surgeon participants to improve their equipment and, at the same time, it provided surgeons with access in a single venue to become familiar with new technology. In turn, the revenues generated provided financial support to reduce the overall cost of the annual meeting to our membership. Additionally, the development of this partnership with industry lead to interest in industry providing support for education and research as well as educational grants to allow more young surgeons to attend the annual meeting. Last year industry supported fifty $1,500.00 scholarships for residents and fellows as well as armed forces surgeons to attend our annual meeting.

Thus began the formation of relationships of “no–strings–attached” philanthropy by industry to promote meaningful research, which has itself helped direct industry to pursue new frontiers of product development. For the past three years our industry partners have contributed substantially to increase the amount of available funds in our philanthropic foundation (the American Foundation for Surgery of the Hand). In turn, we have been able to substantially increase the amount of dollars awarded annually as research grants to our member applicants. This “seed money” has in turn been used to perform research which has additionally garnered substantial full–funding in the form of R01 grants from the National Institutes of Health and other similar organizations. Industry has had the opportunity to ask that their funds be used for research in certain areas (arthritis, soft–tissue, trauma, etc.). This allows them to evaluate current cutting edge research being done by our members and helps them focus on new frontiers of development as they plan their future goals and activities.

This evolutionary process has led to the development of the Corporate Advisory Council (CAC). The CAC has addressed issues of compliance and has generated a list of “Ten Commandments” of Ethical Society/Industry behavior, which can serve as a model for any professional society, and which has led to the publication of a white paper on this topic.

In these pages, we want to tell a story illustrating how potential “conflicts of interest,” if well–managed in terms of guidelines and transparency, can be used to enhance the delivery of health care by a professional society setting a very high “moral bar” and assuring strict enforcement of guiding principles as it brings physicians and industry together.

About ASSH

For over 50 years ASSH has been a leader in the advancement of the science and practice of hand surgery and upper extremity surgery to ensure competency of its members and ultimately the betterment of our patient’s lives. This has been accomplished through an extensive array of courses, meetings, development of educational materials and specialty training curricula. Dissemination of information and knowledge takes place through rigorous oversight at the ASSH Annual Meeting, on–going continuing medical education (CME) meetings throughout the year, its peer–reviewed specialty journal (The Journal of Hand Surgery), and the publication of multiple text and multi–media educational tools.

We believe education and the dissemination of information is a dynamic process as there is a constant need to find new solutions for unsolved existing problems. This requires investigation through multiple layers of clinical and bench research. The ASSH also recognizes this through its partnership with its philanthropic organization. The American Foundation for Surgery of the Hand (AFSH) has been committed to raising funds to support meaningful research in the field of hand and upper extremity surgery. Meanwhile, the practical translation of these efforts into clinical practice requires the manufacturing and marketing and dissemination capabilities of our corporate partners in industry. We, many of our colleagues who are members of the ASSH, and our patients have benefited by our partnerships with industry through the development of improved implants, instrumentation, and fixation devices intended to enhance our ability to deliver surgical care. The development of these products and systems has required the resources of industry that bring not only financial support but engineering and manufacturing capabilities. The evolution from concept to prototype to working system requires a “hand–in–hand” partnership between the surgeon and industry. The ASSH has functioned as a platform on which that partnership can be built.

Because annual member dues, journal subscription rates and attendance fees at meetings and courses are capable of raising only a fraction of the resources needed to meet this mission, outside funding and support made possible by providing a platform for industry to present its new technology through the sale of exhibit space at the Annual Meeting and advertising in the journal, is key to ASSH’s ability to provide all these benefits to its community. Non–CME skills courses allowing industry and its surgeon champions to demonstrate their new technology have also been a source of revenue to support this mission.

To monitor and develop clean and ethical relationships, in 1999 the ASSH Council Board formed the Corporate Relations Committee. All industry relations (conflicts) of any officer or any person presenting educational research data through the Society has been clearly stated and recorded for public awareness.

For example, any surgeon presenting information within any ASSH CME educational forum who gains royalties, research support, consulting fees, stock revenues, etc., must clearly declare such involvement prior to presentation. This declaration unequivocally alerts the audience to the possibility of bias in the presentation and therefore intensifies the level of scrutiny (appropriately) in evaluation of the quality and validity of the information being presented.

Recent Events

In 2005 the United States Department of Justice (DOJ) investigated the five largest orthopaedic companies regarding unethical behavior and kickbacks to surgeons, essentially as an inducement to utilize their products.

Despite having already developed a “no–strings–attached firewall” to maintain an ethical relationship with industry, the ASSH leadership and its key industry partners recognized the importance at this juncture to form a combined leadership council, the Corporate Advisory Council (CAC) to set specific guidelines as a model for all medical societies to follow in their corporate relationships. This process has been undertaken to, “enhance education, improve research for patient care; encourage fairness and consistency; enhance communication between industry groups and physicians, while managing conflict of interest” (American Society for Surgery of the Hand, 2010).

At the corporate advisory council meeting in July 2009, a working group consisting of members of the ASSH leadership, the ASSH executive staff, key representatives of multiple upper extremity device manufacturers and leaders of the American Foundation for Surgery of the Hand poured over documents and resource materials to become intimately familiar with guidelines that had previously been drawn. Many of the corporations had adopted their own guidelines to follow regarding their interactions with physicians as “the physician consultants” and in regards to physician education and marketing, which were carefully studied.

Additionally, we reviewed guidelines from the ADVAMED and PhRMA groups in response to the United States Department of Justice (DOJ) investigation of the five largest companies. The CAC also noted and studied the individual approaches each company and organization had taken on their own to be in compliance in the absence of any specific standards established by the DOJ. In our review, we found that there was no evidence of any previous guidelines, which had been established by any Medical Society or Specialty Society on a voluntary, pro–active basis for its physician membership. Nor was there any evidence that any medical society and corporate group had worked together to develop specific guidelines for the appropriate and essential interactions between the two groups.

The CAC, through all of its membership components, felt strongly that in the area of upper–extremity care, patients would benefit when physicians and industry interact on product development, surgical education and performing outcomes studies to verify the efficacy of common surgical procedures. Our goal was to involve our corporate partners in drafting a set of guidelines that would support ethical interactions between physicians and industry while improving patient care.

The outline of this labor with multiple multidisciplinary panels is the “Ten Commandments” of Society/Industry professional behavior and are listed here:

1. Industry is strongly encouraged to support educational activities to increase knowledge and the skills necessary to improve patient care through the American Society for Surgery of the Hand (ASSH).

2. Industry is strongly encouraged to provide support for research through the American Foundation for Surgery of the Hand (AFSH). The subject and content of the research will be determined by the ASSH/AFSH. Corporations will not control the content of supported research.

3. The ASSH/AFSH will clearly define research programs and methods of selection of topics and researchers receiving donated funds. The AFSH will provide annual updates to donors on the use of those funds.

4. Physicians will be consulted and involved in the development and design of new products as deemed necessary by the device company following a comprehensive review of the specific project requirements as well as the physicians’ credentials, qualifications and expertise on the subject matter by the company.

5. Consulting and design activities will be reimbursed by industry at a fair market value on a per–activity or per–time basis. No ASSH members will accept gifts, funding for companion travel, sponsorship of a recreational activity, entertainment, or sports event.

6. ASSH members and industry will be parties to explicit contracts regarding the scope of service and reimbursement for service.

7. ASSH members will not demand or accept unreasonable reimbursement for travel, meals, and lodging, for being involved in an educational activity.

8. All funding to support education and research will be controlled by the ASSH and AFSH.

9. Companies will not influence the control of educational or research activities.

10. All relationships will be disclosed and readily available to the public (American Society for Surgery of the Hand, 2009).

Evolution of “No–Strings–Attached” Support for Research and Education

Recognizing that financial resources previously set aside by industry for marketing purposes would not fit these guidelines moving forward, frank discussions have been held between the ASSH, AFSH leadership and leaders of corporate members of the CAC to discuss and develop mechanisms to ethically support future research and education in non–conflicted ways. Clearly, the potential exists for bias in research when directly funded by industry. Prior to the DOJ investigation, it was common practice for individual corporations to directly fund resident and fellowship education through grants directly to training programs. There existed a tacit “quid pro quo” of training residents and fellows in the use of that company’s products. Similarly, industry supported research had the potential for significant bias. The “ten commandments” were developed to mitigate and ideally eliminate such behavior in the future.

Through the AFSH/ASSH “future in–hand” campaign designed to raise $4 million dollars over a 3–year period, independent and non–conflicted contributions from our corporate partners added to member donations have enabled us to increase research grant awards from $75K–$100K dollars annually previously, to over $200K–$230K dollars, currently. These seed grants have translated into the realization of $2.4 million dollars of secondary R01 grants from entities such as the National Institutes of Health. In addition, corporate commitments to funding upper extremity fellowships through a totally independent, non–conflicted 501c3 entity (AFSH) has enabled us to begin the development of a new 2–year Complete Upper Extremity Fellowship pilot program.

An additional initiative taken by the ASSH to more quickly improve and enhance patient care has been a market research initiative. The ASSH leadership has recognized that industry has the resources and incentives to develop new and better technology, while the ASSH members as a collective have broad and deep insights as to how resources could best be employed to solve the “unsolved problems” in upper extremity care, using their own clinical experience to guide their opinion. In response, the ASSH has developed detailed questionnaires that delve into the areas of greatest need for hand surgery in terms of new solutions and new products to facilitate new solutions. The initial response to the survey was a 32% response rate within a 2–week time period. This extraordinary response yielded a rich collection of information that is being collated to meaningful data to be shared in the near future with our corporate partners.

At the 2010 ASSH Annual Meeting there was the first ever Symposium presentation on the relationship between ASSH and Industry, reviewing many of these points and outlining the vision we have for future collaboration, with both industry leaders and ASSH leaders presenting their views in an open forum to all attendees.

The guidelines we have developed as a society translate into a daily code of ethics for our individual members in their dealings with industry. They also provide a framework of ethical behavior for industry from its highest leaders to its local representatives. They serve as an educational tool to provide a framework of behavior for medical students, residents and fellows as they embark on their careers in Hand and Upper Extremity Surgery. Moreover, they are translatable to any realm of medicine.


American Society for Surgery of the Hand. (2009). Hand surgeons take ethics into their own hands: Hand surgeons take leadership role in industry relations to ensure patient care. Retrieved from Media release page Online Web site: http://www.assh.org/media/releases/Pages/HandSurgeonsTakeEthicsintoTheirOwnHands.aspx

American Society for Surgery of the Hand. (2010). Relationship between industry and hand surgery: Ethics and Code of conduct [PDF Document]. Retrieved from Annual Meeting Archives Symposium 10 Notes Online Web site: http://www.assh.org/AnnualMeeting/AnnualMeetingArchives/Symposia%20Handouts/05_011_SYMP10.pdf

Copyright © 2011 The Johns Hopkins University Press. Narrative Inquiry in Bioethics, volume 1, issue 2. Used with permission.

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