by Astrid Fiano, reporter

A Senate Special Committee has been examining improper relationships between medical device manufacturing companies and surgeons. On February 27 of this year, the Senate Special Committee on Aging held a hearing on unethical business practices within the medical device industry. The Committee has previously investigated physician/company dealings, and contends that conflicts of interest are prevalent throughout the medical device industry. The problems alleged include company rewards to physicians such as consultant fees, travel gifts, educational grants, and payment for clinical studies. Such rewards can influence medical decisions and recommendations, and even violate federal anti-kickback and/or self-referral statutes.

Committee Chairman Herb Kohl (D-WI) stated that physicians were as culpable as the medical device industry, and that patients' best interest may be compromised by influential relationships. The Committee interviewed surgeons and industry representatives during the hearing. Surgeon-owned medical device companies were also considered to have potential conflicts. Some physicians claimed to investigators that certain medical companies avoided working with them upon the physicians' refusal to accept financial gifts.
Due to growing concerns over possible conflicts of interest, Senator Kohl and Senator Chuck Grassley (R-IA) have sponsored proposed legislation called the Physician Payment Sunshine Act. The Sunshine Act would require pharmaceutical, medical device and biotechnology manufacturers to disclose the monetary amount of economic benefits given to doctors through such means as payments, gifts, honoraria, entertainment, and travel. Major medical device manufacturing companies are supporting this Act, including Medtronic Inc. and the industry group AdvaMed.

Other government agencies have investigated and litigated physician-company relations, including the Department of Justice and the Office of Inspector General for the Department of Health and Human Services. The Department of Justice settled late last year with four medical device manufacturers. The manufacturers paid $311 million to settle the investigation of consulting deals alleged to influence surgeons' decisions on which implants to use.

Most pharmaceutical companies already require disclosure of appropriate physician relationships in marketing communications.

More details can be found at: http://www.aging.senate.gov/hearing_detail.cfm?id=294092&

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