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Leaders note the impact of investigations into industry and physician relationships
The AAOS president cautions that some U.S. attorneys have conducted ‘quiet’ investigations.
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DENVER — The U.S. Department of Justice investigation into the relationships between orthopedic device manufacturers and surgeons has lead to intense scrutiny of physician and industry partnerships and uncertainty about how these relationships will be handled in the future.
At the 27th Annual Meeting of the Arthroscopy Association of North America, E. Anthony Rankin, MD, president of the American Academy of Orthopaedic Surgeons (AAOS), and David Lovett, JD, the director of the academy’s Washington office, discussed the status of ongoing physician and industry investigations, outlined action by AAOS and made predictions about what physicians can expect from state and federal legislators.
Ongoing investigations
Rankin noted that the fallout surrounding agreements made by five orthopedic hip and knee implant companies with the New Jersey District Attorney’s Office continues, and the selection process for the federal monitors stipulated by the agreement has come under question.
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“We are aware that the U.S. attorneys in other jurisdictions have conducted their own quiet investigations and may present their results and findings at any time,” Rankin said. He also noted that the Department of Justice (DOJ) issued subpoenas earlier this year to individual orthopedic surgeons, Wright Medical Group Inc. and Exactech Inc.
Broader examination
The issue has lead to discussion among lawmakers on Capitol Hill. In February, the U.S. Senate Special Committee on Aging held a hearing entitled, “Surgeons for Sale: Conflicts and Consultant Payments in the Medical Device Industry.” At the meeting, some members discussed the Physician Payments Sunshine Act of 2007 (S. 2029). The bill is sponsored by Sen. Chuck Grassley (R-Iowa) and seeks to provide transparency in physician and industry relationships.
“This bill largely places the burden on industry to disclose the payments made to physicians. Medical device companies that have to do this have to have over $1 million in sales,” Lovett said.
The Institute of Medicine (IOM) of the National Academies’ Committee on Conflict of Interest in Medical Research, Education and Practice has held at least three open hearings regarding industry relationships.
“This conflict of interest examination is much broader than the Justice Department investigation and looks broadly at medical research, education, as well as private practitioners, and the potential conflicts of interest,” Lovett said.
The group was expected to have two working closed sessions in August and a report is anticipated in early 2009. “[When] the Institute of Medicine looks at an issue, such as medical error, usually there are ramifications in the public arena,” Lovett said.
He speculated that the Centers for Medicare & Medicaid Services may also push for greater physician disclosure. “It’s very possible that CMS or other such government entities, as conditions of participation, may place additional requirements on physicians,” Lovett said.
Standards
Rankin noted that the AAOS adopted standards of professionalism for orthopedist and industry conflicts of interest which went into effect in January.
“We believe that a cooperative relationship benefits patients,” Rankin said. “Orthopedists are best qualified to provide innovative ideas and give feedback, to conduct research, to serve on scientific advisory boards, to serve as faculty to teach new technology and we rely on industry to bring new ideas to fruition.
We believe that a collaborative relationship is necessary to improve patient care, but we also recognize that it must be carefully scrutinized to avoid pitfalls of improper endorsements either real or perceived.”
For more information:
- E. Anthony Rankin, MD, is the president of the American Academy of Orthopaedic Surgeons. He can be reached at 1160 Varnum St. NE, Suite 312, Washington, DC 20017; 202-526-7031; e-mail: erankinmd@aol.com. He has no relevant financial relationships to disclose.
- David Lovett, JD, is the director of the American Academy of Orthopaedic Surgeons’ Washington office. He can be reached at 317 Massachusetts Ave NE, Suite 100 Washington, DC 20002; 202-546-4430; e-mail: lovett@aaos.org. He has no relevant financial relationships to disclose.
Reference:
- Rankin EA, Lovett D. Mini-symposium: Physician/industry relationships: Navigating the landscape. Presented at the 27th Annual Meeting of the Arthroscopy Association of North America. April 24-27, 2008. Washington.