Critical changes in continuing medical education: Gifts to physicians from industry

Key points 

A note to our readers 

This is the first article from the Continuing Medical Education Committee of the American Society of Reproductive Medicine addressing critical changes related to our ongoing educational goals. Twice yearly Sexuality, Reproduction, and Menopause will include an article addressing such changes. Readers are encouraged to provide input to ASRM about topics for this series.

Because of the recent emphasis in the lay press and the medical press regarding gifts to physicians from industry, this first CME article addresses that critical issue.

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Fig 1. Government agencies and medical associations have drawn a line on corporate influence.

Physicians have long valued continuing medical education. It is expected that medical professionals maintain their expertise in their specialty so they can provide patients with the best and most current medical options. Conferences, written materials, and personal interactions with other professionals allow physicians to stay abreast of the ongoing changes in medical care.

The public expects doctors to be unbiased, so understandably, concerns have been raised regarding the interactions between medical professionals and the pharmaceutical industry. This concern of potential bias—legally defined as fraud—led to regulations from the US Department of Health and Human Services. Although the rules are challenging to interpret, the AMA has provided basic guidelines to inform physicians regarding gifts from industry, particularly those involving continuing medical education.

Why inform physicians of gifts from industry? 

The efforts of pharmaceutical companies to promote their products have increased markedly in the last five to 10 years (1). It was estimated that pharmaceutical companies would spend more than $15 billion for promotion of their products in 2000, a 40% increase from 1997. In the competitive pharmaceutical industry, the contact of sales representatives with physicians is considered critical. It is estimated that sales personnel spend $8000 to $13,000 per year per physician to provide information about their products (2). This large expenditure has led to concerns from physicians, patients, and governmental agencies about gifts provided to medical professionals.

Along with the increase in promotion, there has been concern from physicians and the general public about the money spent educating physicians. Numerous articles describing extremely costly and biased educational programs to physicians have appeared in the past five years. The other side of this issue, which is sometimes not recognized in the lay press, is the importance of educational materials that pharmaceutical companies provide to physicians. It was not the intent of the AMA to prevent reasonable contributions to educational activities; its goal was to limit noneducational gifts and assure that educational programs are unbiased.

Who established these regulations, and when? 

In 1994 the Office of Inspector General (OIG) issued a Special Fraud Alert, which expressed concerns regarding promotion beyond typical advertising and education. It was feared that these might undermine physicians' obligation to “provide treatments and recommend products in the best interest of patients.” In April 2003, the OIG detailed the Compliance Program Guidance for Pharmaceutical Manufacturers, to define inappropriate relationships between physicians and industry. It intended to prevent bribes and kickbacks (3). The Pharmaceutical Research and Manufacturers of America (PhRMA) code was developed by the industry to meet these standards.

In response to the government regulations, the AMA, through the Working Group for the Communication of Ethical Guidelines on Gifts to Physicians from Industry, developed Opinion 8.061.

Published in April 2003, it is available as a pocket-sized card for physicians to personally carry with them at their professional office, at educational meetings, and when interacting with industry representatives. In addition, the AMA provides educational materials to highlight use of these guidelines. They detail the history and legal issues, and provide numerous cases. This material also offers physicians guidance on maintaining an appropriate relationship with industry and sales personnel. The modules include resource materials (presenter's guide, PowerPoint slides, and handouts) and self-study for Category 1 credit toward the AMA Physician's Recognition Award. This material can be obtained free of charge from the web site at www.ama-assn.org/go/ethicalgifts.

Guidelines of the american medical association 

The guidelines are intended to offer basic information about gifts to physicians from industry. Briefly, the seven guidelines are:

It is the intent of these guidelines to ensure that physicians follow the OIG regulations and do not inadvertently commit fraud when accepting gifts from industry. On the other hand, it is also important to allow industry to provide educational materials to physicians and contribute to medical education. By limiting the cost and potential influence of gifts, industry representatives are allowed to interact with physicians. Oversight of educational meetings by national organizations and educational centers allows industry to advance medical education without unacceptable influence on patient care. Finally, limiting the cost of meetings planned by industry, as well as the requirement of disclosure by all speakers, permits modest educational meetings to be sponsored by the pharmaceutical companies.

How can physicians stay informed about gifts from industry? 

Physicians are likely to have questions as they are using these guidelines. The materials available on the AMA's Web site (www.ama-assn.org/go/ethicalgifts) include useful question-and-answer sections and excellent cases representing common issues associated with gifts and meetings sponsored by industry. In addition, materials can be obtained from the AMA about conflicts of interest (Opinion 8.03) and continuing medical education (Opinion 9.011).

Governmental regulations can be challenging to review, but material from the Office of Inspector General is found at www.oig.hhs.gov/fraud/docs/complianceguidance. Materials from the pharmaceutical industry about its code for interactions with health professionals can be obtained from www.phrma.org. The Accreditation Council for Continuing Medical Education (ACCME) provides detailed information on the standards for commercial support of continuing medical education and can be contacted at their website www.accme.org.

Finally, ASRM is pleased to receive questions from physicians and other healthcare professionals. You may direct your continued medical education questions to the Committee or to the CME coordinator, Ms. Beth Hunter, at www.asrm.org.

Conclusion 

Physicians are expected to provide unbiased information to patients. In the past physicians had relatively little oversight from governmental regulations, so the rules regarding gifts from industry surprised many physicians who live by the unspoken ethics of our profession. The clarification of the OIG regulations by the AMA guidelines assures that physicians fully understand these rules, just as the PhRMA codes assist the pharmaceutical industry. The AMA guidelines also assure our patients that we maintain the highest ethical standards regarding the medical options discussed and the medical care we provide.