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Academy examines impact of investigations

By: Mary Ann Porucznik

By Mary Ann Porucznik

During the symposium on “The Evolving Orthopaedic Surgeon-Industry Relationship,” three Academy fellows and an industry representative joined attorney Howard J. Young, JD, and Lewis Morris, JD, chief counsel to the Department of Health and Human Services, Office of the Inspector General, to assess the impact of the ongoing investigations. AAOS First Vice President E. Anthony Rankin, MD, opened the session by recapping recent events, from investigations by the Department of Justice into pharmaceutical and orthopaedic device manufacturers in 2005 to the Senate Committee on Aging hearing held just last week. As headlines such as “Whistle-blower suit says device maker generously rewards doctors” and “Surgeons for sale” flashed on the screen behind him, it was easy to see how patient trust in orthopaedic surgeons could be eroded.

Christopher L. White, JD, general counsel for the Advanced Medical Technology Association (AdvaMed), the industry trade association, discussed steps taken by manufacturers to ensure compliance with the law. Although the AdvaMed Code of Ethics is voluntary, he said, it has been given some standing by its incorporation into the recent Deferred Prosecution Agreements. In addition, he encouraged audience members to contact the compliance officers of the AdvaMed member companies if they have any questions.

Murray J. Goodman, MD, chair of the Board of Councilors/Board of Specialty Societies Professionalism Committee and a member of the Committee on Professionalism, reviewed the AAOS Standards of Professionalism on Orthopaedist-Industry Conflicts of Interest. He encouraged them to visit the AAOS Industry Relationships Web site (www.aaos.org/industryrelationships) and to take advantage of the discussion hotline (industryconflicts@aaos.org).

AAOS President James H. Beaty, MD, delivered a strong message. “There is no place for illegal or unethical relationships in this Academy,” he said. “The trust of our patients and the public mustcome first.”

Acknowledging that there is a place for appropriate scientific partnerships, Dr. Beaty also noted that many education and humanitarian ventures depend on relationships with industry. “Positive, ethical partnerships benefit patients,” he said.

Impact on research
Finally, Stuart L. Weinstein, MD, a past president of the AAOS, took out his crystal ball to address the impact of current enforcement activities on orthopaedic research and education. Clinicians seeking continuing medical education (CME), educators of medical undergraduates and graduates, clinical and basic science researchers, and CME organizations such as the AAOS and specialty societies will definitely see an impact, he said.

Stuart L. Weinstein, MD

In surgical specialties, said Dr. Weinstein, the best research evidence is heavily dependent on clinical research and clinical trials, which are very expensive. But federal funding for the National Institutes of Health (NIH) is flat, and through 2008, the NIH has lost one-seventh of its purchasing power due to inflation. As the burden of musculoskeletal disease increases, federal dollars alone will be unable to support needed research.

Already, 43 percent of medical researchers receive research-related gifts and one-third have personal financial ties with the sponsor of their research. These relationships raise questions such as: Is the principal investigator really the principal investigator? Who owns the data? Is the statistician analyzing the data independent of the sponsor? Who is the true author? Can any investigator who is paid substantially or on a retainer be truly objective in analyzing the data?

The Association of American Medical Colleges and the Association of American Universities have recently released new guidelines calling on medical schools and major research universities to develop and implement institutional financial conflicts of interest (COI) policies within the next 2 years, and to refine standards for addressing individual financial COI. As a result, said Dr. Weinstein, a firewall is being built between industry and education and research.

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