By Kenneth Kaushansky, MD, and Roy L. Silverstein, MD

2009-01-01

Dr. Kaushansky is Helen M. Ranney Distinguished Professor and Chair, Department of Medicine, University of California, San Diego. He is also Past-President of ASH.

Dr. Silverstein is Editor-in-Chief of The Hematologist.

Recently, we have seen heightened attention by government officials and news media on financial relationships between physicians and manufacturers of pharmaceuticals and medical devices. A few notable cases of physicians and surgeons receiving six-figure "consulting" fees to promote drugs and devices often with little or no public disclosure have heightened interest. In this context, the Pharmaceutical Research and Manufacturers of America (PhRMA) have revised their “Code on Interactions with Healthcare Professionals” for the first time since 2002. The updated voluntary Code, which went into effect in January, is part of an ongoing effort to reassure the public that pharmaceutical marketing practices comply with ethical standards. It reaffirms that interactions between company representatives and health-care professionals "should be focused on informing health-care professionals about products, providing scientific and educational information, and supporting medical research and education." 

The revised Code prohibits distribution of non-educational items (e.g., pens, mugs, and other "reminder" objects) to health-care providers and their staff and goes beyond previous rules by stating that companies should not provide any entertainment or recreational benefits (e.g., restaurant meals, theater and sports tickets, etc.) to health-care professionals. The Code still, however, allows sales reps to provide occasional meals in physician offices and restaurants in conjunction with informational presentations and at national and regional medical society meetings.

The Code also includes new provisions related to disclosure and employee education. Companies must ensure that their representatives are sufficiently trained in applicable laws, regulations, and industry codes of practice, including the Code, that govern interactions with health-care professionals. Companies are also asked to assess their representatives periodically and to take appropriate action if they fail to comply with relevant standards of conduct.

Companies must also state their intention to abide by the Code and that their CEOs and Compliance Officers will certify each year that they have processes in place to comply, a system patterned after the Sarbanes-Oxley regulations. Companies are encouraged to obtain periodic external verifications that they have processes in place to foster compliance with the Code. PhRMA will post on its Web site a list of all companies that announce their pledge to follow the Code, contact information for company compliance officers, and information about their annual compliance certifications.

Other additions to the Code include more detailed standards regarding the independence of continuing medical education (CME), principles on the responsible use of non-patient-identified prescriber data, and additional guidance for speaking and consulting arrangements with health-care professionals, including disclosure requirements for health-care providers who are members of committees that set formularies or develop clinical practice guidelines and who also serve as speakers or consultants for a pharmaceutical company. 

Questions remain about implementation of a number of aspects of the new Code. Although manufacturers are required to set limits on consulting and speaking fees, the limits are not actually defined, and public disclosure of consulting and speaking relationships is not mandatory. It is also important to note that the Code applies only to Big Pharma; device manufacturers and biotech industries have their own trade organizations and have chosen not to follow suit with their own codes of conduct.

Given public interest in relationships between physicians and pharmaceutical companies, the revised Code will not close the book on the conflict-of-interest issue, or put a halt to continued government and media scrutiny. As physicians, we may ask what role industry should play in setting our own professional standards of behavior. What role should our professional societies play, and for those of us in academic medicine, what role should our employers play?

Among the medical professional societies, ASH has been at the forefront in dealing with conflicts of interest by developing detailed policies that preserve the scientific integrity of the discipline while allowing productive interactions with industry. ASH’s mission does not include marketing of pharmaceutical or biomedical products, yet opportunities exist for purchase of space for commercial displays at the annual meeting and other smaller meetings, and for purchase of advertising in Blood. ASH mandates that revenues generated from these activities be devoted to the support of the Society’s mission and that advertisers have absolutely no role in determining the scientific or educational content of the journal or any ASH meeting or CME activity. ASH uses disclosure and peer review to identify potential conflicts and encourages hematologists to question speakers if they suspect that the information provided is in any way biased. Commercial support for CME is acknowledged publicly, and attendees are always provided with a formal opportunity to report on their perceptions of any possible bias. To ensure transparency and compliance, every ASH committee has a conflict-of-interest compliance officer, and all of the many professional volunteers who provide leadership to ASH by serving as officers, members of standing committees, editors of ASH publications, or faculty in ASH-sponsored educational activities must provide a detailed conflict-of-interest disclosure. A centralized, Web-based, conflict-of-interest registry for ASH will be online no later than 2010.

ASH has not taken a position on the interactions of its members with industry outside of ASH-sponsored activities. Should it? Tell us what you think. We also encourage your feedback on the revised PhRMA Code and current ASH conflicts of interest policy. Please send your comments to klearner@hematology.org.

For More Information

ASH’s policies and practices were formulated by the ASH Executive Committee during its spring meeting. On May 22, 2008, Dr. Kaushansky presented oral testimony to the Institute of Medicine (IOM) on conflicts of interest between medical societies and the pharmaceutical industry and the policies that ASH has implemented to safeguard against introducing bias into ASH’s meetings, publications, and positions.

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