The American Medical Association’s Code of Ethics states, “Under no circumstances may physicians place their own financial interests above the welfare of their patients. The primary objective of the medical profession is to render service to humanity; reward or financial gain is a subordinate consideration.

So how does the health care profession balance this against efforts by biotechnology and pharmaceutical manufacturers to inform physicians about new drugs, devices and other products? In a time of heightened awareness of physician financial relationships and incentives, there’s much for you to consider.

THE RELATIONSHIPS
Concerns about the appropriateness of these relationships arise in clinical research settings, institutional product selection and exclusive vendor relationships. But the most recognized area of concern is the individual industry-physician relationship.

The fear is that these relationships will bias physician decision-making in a way that undermines the quality of patient care and unnecessarily increases health care costs. Many associate fraud and abuse risks with these relationships, and physician codes of ethics (as mentioned above) recognize the risk to the physician-patient relationship. In fact, according to a 2003 study appearing in the Journal of the American Medical Association, research has revealed that gifts, no matter how small, can cause recipients to lose objectivity and perceive a reciprocal obligation to the gift-giver.

AAMC’S POSITION
The Association of American Medical Colleges (AAMC) recently considered a task force report on developing guidelines to manage industry-physician relationships. This report recommends, among other things, the development of policies that prohibit all gifts from industry for physicians, faculty, staff, students and trainees of academic medical centers (AMCs), either on-site or off-site. The report also recommends that the prohibition apply to equipment and service vendors.

According to the report, medical centers should discourage their faculty, students and trainees from:

• Attending nonaccredited industry events that are marketed as continuing medical education (CME),
• Accepting payment for attendance at industry-sponsored meetings,
• Accepting gifts from industry representatives at meetings, and
• Participating in “ghostwriting.”

Further, the task force recommends that pharmaceutical representatives not be permitted access to patient care areas; that device representative visits be limited to those who are appropriately credentialed; and that such visits be only at the request of a physician.

PhRMA’S RESPONSE
For its part, the pharmaceutical industry has created its own voluntary set of guidelines on physician financial relationships. In its 2004 Code on Interactions with Healthcare Professionals, the Pharmaceutical Research and Manufacturers Association (PhRMA) adopted less stringent guidelines with respect to gifts for physicians and other health care providers.

But in July 2008, PhRMA issued a revised code, effective January 2009. Among the key changes to the code is PhRMA’s new prohibition on the distribution of pens, mugs and other “reminder” products. PhRMA notes that such items, while minimal in value, may foster misperceptions that company interactions with health care professionals aren’t based on informing them about medical and scientific issues. The revised code also prohibits sales representatives from providing restaurant meals to health care professionals. But it permits occasional meals in a health care professional’s office in conjunction with an informational presentation.

CME CONCERNS
To some, pharmaceutical- or biotech-company-sponsored educational activities and programs are ways to promote a company’s product and to further bias the clinical decision-making of physician-attendees. To mitigate these risks, the AAMC’s task force recommends that it coordinate all industry support for CME through an AAMC central office.

The organization also wants medical centers to audit programs to ensure industry-sponsored CME programs comply with accreditation standards. In particular, the Accreditation Council for Graduate Medical Education (ACGME) recommends that individuals involved in determining the content of an education activity disclose relevant financial interests, and states that failure to do so should disqualify an individual from acting as a CME planning committee member, presenter or author.

Research has revealed that gifts, no matter how small, can cause recipients to lose objectivity.

PhRMA’s updated 2008 code recommendations regarding CME are similar. For example, PhRMA recommends that a company separate its CME grant-making functions from its sales and marketing departments and that any subsidy for an educational program be given to the CME provider, who in turn can use the funds to reduce the overall CME registration fee.

PhRMA further states that, when companies underwrite CME, the responsibility for and control of the program’s content, faculty, materials and venue belong to the program organizers. Even if asked by the organizer, the company shouldn’t provide any advice or guidance regarding the CME content or faculty.

WHAT SHOULD YOU DO?
Over the past few years, some academic centers have already adopted strict no-gift policies that prohibit physicians from accepting any type of remuneration from industry representatives. Most hospitals and organizations have found this type of policy difficult to implement and instead have chosen a middle-of-the-road approach, allowing items of minimal value if they’re primarily associated with the health care professional’s practice (pens or mugs for office use), while not permitting items that primarily benefit the professional, such as tickets to a sporting event, or cash (or cash equivalents), except as compensation for bona fide services.

But with the AAMC’s recent task force report and PhRMA’s new, stricter gift policies, it appears the trend is continuing toward fewer opportunities for – and perhaps less tolerance of – influence from pharmaceutical and biotech companies. If you haven’t already done so, revisit your financial relationship and gift policies and consider whether more strict rules regarding gifts, meals and CME are appropriate.

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