Crystal ball isn’t needed to know trouble’s brewing

The Annual Meeting symposium on “The Evolving Orthopaedic Surgeon-Industry Relationship” featured Lewis Morris, JD, chief counsel to the Department of Health and Human Services, Office of the Inspector General (see story, page 1). Additional perspectives on the impact of the ongoing investigations were provided by three Academy fellows, an industry representative, and attorney Howard J. Young, JD.

Getting to this point
Tony Rankin, MD, the 2008 AAOS president, 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 Special Committee on Aging hearing held at the end of February. 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.

Dr. Rankin ended by noting the ongoing investigations being conducted by the US Attorney for New Jersey, Christopher J. Christie, who has subpoenaed two smaller orthopaedic device makers and individual surgeons. He cited the introduction of the “Physician Payments Sunshine Act” and a Congressional request to the Government Accounting Office to launch an inquiry into the “use, award, and implementation of contracts by the Department of Justice to outside entities for the monitoring of compliance with out-of-court-settlements and deferred prosecution agreements in criminal investigations.”

Industry moving to compliance
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 being incorporated into the recent government agreements with the five major orthopaedic hip and knee implant manufacturers. In addition, he encouraged audience members to contact the compliance officers of the AdvaMed member companies if they have any questions.

Under the AdvaMed Code of Ethics, healthcare professionals who serve as consultants may receive reasonable compensation for bona fide consulting services and reasonable and actual expenses incurred. Consulting arrangements must be written, signed, and specify the purpose and need for services as well as the fair market value of compensation. Selection of consultants must be made on qualifications and expertise, not referrals or product usage.

Although companies may provide modest, occasional gifts to healthcare professionals, these gifts must benefit patients or serve a genuine educational function. Gifts may not have a fair market value of more than $100 (except for text books or anatomic models). No cash or cash equivalents can be exchanged between companies and healthcare professionals.

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

AAOS 2007 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 must come 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 and education
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. In surgical specialties, said Dr. Weinstein, the best research evidence depends heavily on clinical research and clinical trials, which are very expensive. But recent flat federal funding for the National Institutes of Health (NIH) has resulted in an inflationary loss of one-seventh of the NIH’s purchasing power. As the burden of musculoskeletal disease increases, said Dr. Weinstein, federal dollars alone will be unable to support research.

Already, 43 percent of medical researchers receive research-related grants and one third have personal financial ties with the sponsor of their research. Such relationships raise questions such as “Is the principle investigator really the principle investigator? Who owns the data? Is the statistician analyzing 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 more stringent institutional financial conflicts of interest (COI) policies within the next 2 years, and to refine standards for addressing individual financial COI. This may result, said Dr. Weinstein, in a more effective firewall between industry on the one hand and education and research on the other.

What’s next?
Howard J. Young, JD, a partner in the firm of Sonnenshein Nath and Rosenthal LLP, pointed out that most orthopaedic surgeons do not have consulting relationships with industry. He warned, however, that because whistle-blower suits are sealed when they are filed, more federal investigations—and possible indictments—may be forthcoming. He advised the audience to also be aware of the legal climate in their states, noting that some states attorneys general may look to prosecutions under the False Claims or Anti-Kickback Acts to make a name for themselves.

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