William R. Sexson, M.D., and Deborah K. Cruze, J.D., M.A.

The Accreditation Council on Graduate Medical Education (ACGME) has recently required that six core competencies be taught to all physicians in training. These professional competencies form the basis of ethical medical practice and must be demonstrated by all residents. The competencies include:

1) compassionate, appropriate, and effective patient care;

2) current knowledge of established and evolving biomedical, clinical and cognate sciences and the application of this knowledge to medical practice;

3) evaluation of patient care and appraisal of current scientific evidence in order to improve patient care;

4) effective communication and interaction with patients to promote effective care;

5) commitment to professional responsibilities, ethical principles and sensitivity to diverse patient backgrounds; and

6) awareness of the larger system of health care and the effective use of the system’s resources to provide optimal health care.

The physician’s fiduciary obligation to the patient is grounded in these core competencies.

The core fiduciary responsibility of the physician for his/her patient is summarized in the AMA Code of Medical Ethics, Current Opinions with Annotation 2004-2005, which is regularly updated and published by the American Medical Association (AMA) Council on Ethical and Judicial Affairs. This book forms the foundation and defines the floor for ethical medical practice. In the latest edition, the AMA notes that, “The relationship between patient and physician is based on trust and gives rise to physician’s ethical obligation to place patients’ welfare above their own selfinterest and above obligations to other groups, and to advocate for their patients’ welfare.” (AMA Code.... , p. 300, opinion 10.015) In section 8.03 of this book the AMA lists their guidelines for avoiding conflict of interest. Specifically:

• “If a conflict develops between the physician’s financial interest and the physician’s responsibilities to the patient, the conflict must be resolved to the patient’s benefit. ...For a physician to unnecessarily hospitalize a patient, to prescribe a drug or conduct diagnostic tests for the physician’s financial benefit is unethical.” (AMA Code.... , p. 174)

• “If a physician becomes involved in a pharmaceutical industry’s research, the physician cannot ethically buy or sell the company’s stock until the involvement ends AND the results of the research are published. Further, any payment of the physician by this company should be commensurate with the efforts of the physician. (AMA Code.... , p. 174)

The AMA delves even further into the realm of conflict of interest by noting that disclosure of payments by the pharmaceutical or equipment manufacturer should include transfer of money (including stock or other valuable assets), financial ties, payment for participation in educational activities, participation in other research funded by the companies, consulting arrangements and any other tie where the physician benefits from his/her relationship with the manufacturer. Disclosure of these arrangements should be made in writing to the medical center where the research is conducted, to organizations funding any research in which the physician is involved, and to journals and meetings where the research is presented. Addi-tionally, the physician’s patients and other physicians must be notified of the potential for conflict of interest. (AMA Code...., p. 178-179)

A real problem for many physicians is recognizing the pharmaceutical industry’s representative. At times this is the drug rep who visits the office, but at other times the manufacturer’s representative may be the physician who is giving a presentation or writing a paper. The “physician-rep” may receive an honorarium, research funding, or travel and salary support from the pharmaceutical industry. These arrangements create a situation where the “physician-rep” researcher or teacher has a genuine conflict of interest, but where the physician being taught is unaware of the bias.

It is obvious that these various company representatives receive money to help in selling the company’s products. To be sure, the company and its agents are hopeful that their products will be of use to the patient, but the sales techniques used are meant to sell their products irrespective of the relative or absolute benefit of the product to the patient. Examples of the sales techniques used include: physician targeting, peer influence, physician self-influence, direct-toconsumer marketing through mass media and targeting private and public insurers. Physician targeting is a common and insidious type of marketing. It forms the basis for the manner and type of gifts and visits that ultimately occur. Commercial vendors compile the writing patterns for a particular physician and the prescriptions written over a period of time. The vendor reviews the profitability of the drugs selected for prescribing, the accessibility of the physician, the tendency of the physician to use a particular company’s drugs, the adoption sequence after marketing and the use of a wide or narrow palette of drugs. This information helps to determine the optimal reach and frequency of visits to a particular physician or physician group. Another form of marketing takes place through peer influence. Key physician opinion leaders are selected based on the physician’s reputation and esteem within the professional community. These physician opinion leaders provide peer influence through social events, professional affiliations, educational offerings, research reviews, and common hospital and medical school affiliations.

It is obvious that these various company representatives receive money to help in selling the company’s products. To be sure, the company and its agents are hopeful that their products will be of use to the patient, but the sales techniques used are meant to sell their products irrespective of the relative or absolute benefit of the product to the patient. Examples of the sales techniques used include: physician targeting, peer influence, physician self-influence, direct-toconsumer marketing through mass media and targeting private and public insurers.

Physician targeting is a common and insidious type of marketing. It forms the basis for the manner and type of gifts and visits that ultimately occur. Commercial vendors compile the writing patterns for a particular physician and the prescriptions written over a period of time. The vendor reviews the profitability of the drugs selected for prescribing, the accessibility of the physician, the tendency of the physician to use a particular company’s drugs, the adoption sequence after marketing and the use of a wide or narrow palette of drugs. This information helps to determine the optimal reach and frequency of visits to a particular physician or physician group. Another form of marketing takes place through peer influence. Key physician opinion leaders are selected based on the physician’s reputation and esteem within the professional community. These physician opinion leaders provide peer influence through social events, professional affiliations, educational offerings, research reviews, and common hospital and medical school affiliations.

Marketing often occurs in the form of gifts: free drug samples, food, books, mugs, clipboards, and brochures. Gifts from companies cost money, influence behavior, and create a feeling of obligation which may consequently cause the receiving physician to feel a need to reciprocate. By creating this psychological attachment, the pharmaceutical representative may cause the physician to feel entitled to the gift or free meal and this sense of entitlement erodes professional values.

Advertising takes place through journal ads as well as through direct-to-consumer marketing. In 1993, the direct-toconsumer expenditures by pharmaceutical companies were $151,000,000. In 1999, these expenditures had grown to $1,850,000,000, a 12-fold increase. (Findlay S, “Direct to Consumer Promotion of Prescription Drugs,” Pharmacoeconomics 2001, 19(2), pp109-119.) In 2002, Rosenthal et al. compared promotional costs to professionals compared to the consumer. He found that direct-to-consumer costs for the year 2000 were $2,467,000,000 as opposed to the promotions made to professionals which totaled $13,241,000,000 for the same period. (Rosenthal, et al., NEJM 2002, 346(7), pp 498-505). Clearly physicians must remain wary since a majority of the pharmaceutical industry’s promotional money is directed toward influencing the physician.

In summary, all physicians have a fiduciary obligation to their patients. The very nature of this obligation requires that physicians avoid any potential or real conflict of interest. Because of the ubiquitous and frequently subtle nature of the marketing tactics used by industry they must be watched for and (to the extent possible) avoided.

William Sexson, M.D., is a neonatologist and associate dean for clinical affairs at Emory University in Atlanta, Georgia. He is on the board of the Emory Center for Ethics.