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Group leaders Michael McBreyer (left) of dj Orthopaedics, LLC, and Frank Kelly, MD, chair of the AAOS Communications Cabinet, presented a report on direct-to-consumer advertising.

AAOS Now

Published 7/1/2007
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Mary Ann Porucznik

Corporate Advisory Council tackles technology, conflicts of interest

Group fosters communication, addresses areas of mutual concern for AAOS, industry

The Corporate Advisory Council (CAC), a group of nearly 50 companies serving the orthopaedic market, serves as an important link between AAOS fellows and industry. During their May 17 meeting, CAC representatives and AAOS leaders focused on training for new technology, communicating with the public, working together to improve patient care, and defining appropriate and legal relationships between orthopaedic surgeons and industry.

AAOS CEO Karen L. Hackett, FACHE, CAE, co-chaired the meeting with R. William Petty, MD, chairman and CEO of Exactech, Inc. In reviewing the results of a spring survey of CAC members, Ms. Hackett noted that responding companies expressed the greatest interest in the following five main areas, which became the basis for the meeting program:

  • educating orthopaedic surgeons and industry staff about ethical relationships between orthopaedic companies and physicians
  • shaping the AAOS Annual Meeting so that it is a win-win situation for the surgeon member and the industry that supports it
  • communicating with the public—direct-to-consumer issues, joint public relations programs—to show the public the benefits of orthopaedic treatment
  • ways of working together to improve patient care
  • the future of continuing medical education (CME)—new modalities, new requirements, new ways of cooperating

Training for new technology
The panel on training for new technology, moderated by Alan M. Levine, MD, chair of the AAOS Council on Education, included Joshua J. Jacobs, MD, chair of the AAOS Council on Research, Quality Assessment and Technology; Pamela Bennett, RN, executive director of healthcare alliance development for Purdue Pharma LP; Dr. Petty; and Richard Peterson, JD, AAOS general counsel.

Dr. Levine noted that the AAOS is making technology assessment a priority, as indicated by the board’s April workshop on the issue (see article on page 35). He also raised several issues, including public perceptions of who trains physicians and how they are trained; training for surgical skills and new technology usage; optimal methods for training; and the accreditation and evaluation of training programs.

Dr. Jacobs reviewed the steps the AAOS is taking to address this issue, beginning with the establishment of a project team. “There is broad support from AAOS members for the Academy to address the issue of new technology,” he said, pointing to the results of several member surveys. As part of this charge, the Academy must also address complications, liability, and patient safety issues.

He defined technology assessment as “the process of systematically reviewing existing evidence and providing an evaluation of the effectiveness, cost-effectiveness, safety, and impact, both on patient health and on the healthcare system, of medical technology and its use.”

“Our fellows trust our objectivity, and if the AAOS seeks to be the authoritative source of knowledge and leadership in musculoskeletal health, as our vision states, we should not be silent,” concluded Dr. Jacobs. “We can say something, but we will not make product comparisons or recommendations.”

Dr. Petty noted that training for new technology depends on the surgeon, the procedure, and the method. An experienced surgeon may need less training than a new surgeon; soft-tissue procedures are often difficult; and training may involve written or electronic technical manuals, interactive modules, or attendance at courses. In assessing the effectiveness of training, Dr. Petty noted that patient outcomes are the true assessment of learning. He also said that orthopaedic surgeons prefer training that is close to home and cost-effective.

Finally, the panel outlined the following process for technology assessment:

  • Define, and then refine, the issue.
  • Review the literature.
  • Assess the evidence.
  • Translate the results to a usable format.
  • Disseminate the information.
  • Update the information regularly, as necessary.

A survey of the audience after the presentations found that 55 percent thought that primary responsibility for technology training should be shared between the AAOS and industry, while 27 percent believed that the AAOS alone should have primary responsibility. More than two thirds (68 percent) of respondents said that hospitals should be responsible for determining competence on new technologies, while the remainder indicated that the AAOS should determine competence.

A win-win situation
Colin F. Moseley, MD,
chair of the Annual Meeting Committee shared how the Annual Meeting is a “win-win” situation for the AAOS and industry. The Academy informs members about exhibitor activities through mailings, Web updates, AAOS Now articles, and an annual exhibitor directory with floor plans and company descriptions. “We also provide services to assist exhibitors in increasing their return on investment by offering Webinars, Web site resources, convention center site visits with large companies, and staff visits to individual companies,” explained Dr. Moseley.

Promotion of the exhibits at the meeting includes exhibitor directory kiosks and an exhibit hall directory. In recent year, the Academy has instituted some “dedicated exhibit hours,” during which there is no competing educational programming. Other recent innovations include complimentary beverage breaks located in the exhibit hall, and redemption centers help draw traffic to every corner of the hall. Exhibitors are given the opportunity to express their viewpoints through surveys, the Exhibitor Advisory Council, the Corporate Advisory Council, and the Open Forum meeting held at the Annual Meeting.

Group leaders Michael McBreyer (left) of dj Orthopaedics, LLC, and Frank Kelly, MD, chair of the AAOS Communications Cabinet, presented a report on direct-to-consumer advertising.
(From left) R. William Petty, MD, co-chair of the Corporate Advisory Council, discusses ways to educate AAOS members about conflicts of interest with industry with Alan M. Levine, MD, Education Council chair, and Frank Kelly, MD, Communications Cabinet chair.

“The recent 2007 meeting survey demonstrated that 83 percent of exhibitors were satisfied that the AAOS Annual Meeting meets their goals of increasing company awareness or image, developing new leads and demonstrating existing products/services,” said Dr. Moseley.

Who belongs in the OR?
The CAC also focused on how industry and the AAOS could cooperate within legal and ethical guidelines. Robert H. Haralson III, MD, MBA, director of medical affairs reviewed the AAOS response to the American Medical Association’s Council on Ethical and Judicial Affairs (CEJA) report on “Industry Representatives in Clinical Settings.”

In its response, the AAOS noted that “the role of the industry representative is to assist inexperienced operating room (OR) personnel in assuring that all of the proper and necessary instrumentation and implants are present and in good repair,” not to train surgeons as they are using the device. In addition, the requirements for patients’ informed consent to the presence of an industry representative in the OR were deemed to be “onerous.”

“We must educate hospitals that industry representatives in the OR are there as a service,” said Dr. Haralson, “not to make the sale. That decision has already been made.”

Advertising, patient care, and conflicts of interest
Three break-out groups addressed the issues of direct-to-consumer (DTC) advertising, cooperation to improve patient care, and education on orthopaedist-industry conflicts of interest.

In their summary report, group leaders Frank B. Kelly, MD, chair of the communications cabinet, and Michael McBrayer, senior vice president at dj Orthopaedics, LLC, noted that $3.2 billion was spent on DTC advertising in 2003, and that physicians, in general, have a negative overall reaction to DTC advertising. The group also discussed the possibility of a “seal of approval” for advertising and a patient education magazine.

AAOS Second Vice President Joseph Zuckerman, MD, and Roger Boggs, director at DePuy, Inc., presented the report from the second break-out group, on improving patient care. The group identified several ways that industry could work with the AAOS in the areas of research, education, and advocacy. In the area of advocacy, for example, the group suggested that the AAOS might have data that industry needs to approach federal agencies, as occurred when the AAOS and the Orthopaedic Trauma Association approached the Department of Defense for research funding on extremity war injuries.

Educating orthopaedic surgeons on conflicts of interest requires “more than a sales piece,” according to the third break-out group, led by Dr. Levine and Austin Byrd, vice president of ethics, compliance, and professional affairs for Smith & Nephew, Inc. Currently, a lack of awareness, confusion about the regulations under different ethical codes (AAOS, AdvaMed, and PhRMA), and a failure to follow regulations present major problems. Model agreements, ongoing education, and appropriate disclosure are needed to address the problem.

Although the attendees acknowledged that cooperation between orthopaedic surgeons and industry is necessary to develop and refine devices and techniques, they also stressed the need to document these relationships through contracts and to disclose them as appropriate.

“There are some real issues here,” summarized Dr. Petty, “and we may get some black eyes. But we need to start here and now to change behavior, which will lead to a change in image for both surgeons and industry.”

Before concluding the meeting, AAOS President James H. Beaty, MD, and Ms. Hackett presented an update on Academy activities, particularly regarding guidelines development, the joint replacement registry, 75th anniversary plans, the professional compliance program, and Orthopaedic Knowledge Online.

Mary Ann Porucznik is managing editor of AAOS Now. She can be reached at porucznik@aaos.org

About the CAC
The Corporate Advisory Council (CAC) is the primary forum for the exchange of information between the AAOS and corporations with business interests in orthopaedics. Such information includes issues covering policy, ethics, education, legislation, and other areas of mutual concern, with a primary focus on providing the highest quality of care for patients with musculoskeletal conditions. The CAC operates within all rules governing the relationship between medical associations and industry and the appropriate legal interactions between and among companies.

The CAC has the following goals:

  • To foster communication between the Academy and the individual companies that comprise the CAC
  • To encourage and support public education and public relations programs that increase the public’s awareness of the special skills of the orthopaedic surgeon and the efficacy of orthopaedic health care
  • To foster a sense of common purpose among orthopaedic surgeons, the Academy, individual orthopaedic companies and the Orthopaedic Research and Education Foundation, while respecting and preserving the proprietary interests of all of the participating organizations and companies