Managing Conflicts of Interest

Conflict of interest has been defined as "a set of conditions in which professional judgment concerning a primary interest (such as patient's welfare or the validity of research) tends to be unduly influenced by a secondary interest." ^[149] Secondary interests are financial, personal, and professional, and they include gaining prestige, promotion, personal gratification, and respect.^{[150] [151]} Characterizing conflict of interest as a condition emphasizes that it is external to the actor and does not impugn motives. The goal is to learn to recognize and manage the ever-present conflicts of interest.^[152] Managing conflicts of interest is essential in developing and preserving the trust patients have in their doctors and society has in the medical profession. Anesthesiologists need to be able to ascertain the potential severity of the conflict, determine the likelihood that their professional judgment will be influenced or appear to be influenced by the secondary interests, and determine the seriousness of the harm that may result from the influence or the appearance of influence.^[149]

Conflict of interests may occur in clinical practice or research. For anesthesiologists, the foremost clinical conflict of interest is production pressure. Production pressure has been defined as "the internal or external pressure on the anesthesiologist to keep the operating room schedule

3191

Another conflict of interest involves the physician's relationship with industry. Consistent with being a business, the pharmacologic industry devotes upward of $11 billion each year in marketing to advertise its products and influence opinions.^{[153] [154]} Although physicians claim that gifts and associations with industry do not influence their practices, evidence suggests that intimacy with industry may unconsciously affect behavior, perhaps out of insensible gratitude, obligation, or comfort with familiar people and interactions.^{[149] [155] [156] [157]} A primary goal of advertising is to influence recipients in such a way that they do not realize the effect of advertising.

Physicians may be so comfortable with the current system that they are unable to recognize the appearance of impropriety.^[158] In a survey of patients, 82% of respondents knew that physicians often received gifts from industry for use in their office, such as pens and notepads, and 32% were aware that physicians received personal gifts such as clocks, radios, and expensive dinners.^[159] Although 13% and 26% of respondents thought that office gifts affected the quality and cost of care, respectively, about twice as many thought that personal gifts affected the quality and cost of care.

Although the appearance of impropriety is important, the basic question is whether industry co-opts physician decision-making by impairing the decision-making process. Wazana^[153] provides a detailed and categorized review of this literature. Incomplete or colored statements from detail men to physicians are common.^{[158] [160] [161] [162]} Materials distributed by drug companies often lack a "fair balance between the benefits and risks of drugs."^{[163] [164] [165]} In one study, 11% of statements made by pharmaceutical detailers at hospital teaching conferences were considered erroneous. All of the erroneous statements made the drug look more favorable, and none of these statements was challenged by members of the audience.^[166] Physicians who requested formulary additions were more likely to request drugs from companies from which the physicians had accepted legitimate money or had contact with detail men compared with physicians who had no such interactions.^[167] Physicians who received paid trips to luxury resorts to learn about specific drugs had increased extent and rate of use of those drugs compared with cohort institutions. ^[157]

Industry may legitimately argue that educating physicians and educating about the availability and use of new medications is a public service. ^{[168] [169]} However, patients benefit only if their physicians have unbiased information and untainted decision-making processes. In theory, physicians independently evaluate industry information, but in practice, physicians gain most of their knowledge from casual sources such as brochures, advertisements, detail persons, and informal conversations, perhaps because of a lack of time, ability, or inclination to evaluate more critically reviewed information.^{[170] [171] [172] [173]}

Out of concerns for inappropriate influence, the AMA has developed Gifts to Physicians from Industry guidelines.^[174] These can be considered the minimum standards. In part, the AMA guidelines permit gifts of nominal value that benefit patients, such as textbooks and modest meals in association with educational functions. The guidelines define an educational function as one in which "(a) the gathering is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse (one or more educational presentations should be the highlight of the gathering), and (b) the main incentive for bringing attendees together is to further their knowledge on the topics being presented. An appropriate disclosure of financial support or conflict of interest should be made."^[174] Some would argue for more stringent standards. For example, the Canadian Medical Association prohibits physicians from accepting personal gifts from industry.

In research, physicians and institutions may have financial and nonfinancial conflicts of interest.^[175] Reporting requirements tend to be based on the extent of equity obtained. The temptation to cheat for advancement and the harm of fraud may be seen in the problems with a breast cancer trial. In 1985 and 1989, the New England Journal of Medicine published papers from the National Surgical Adjuvant Breast and Bowel Project discussing the superiority of lumpectomy over mastectomy for breast cancer. In 1994, the following story was published.^{[176] [177]} In 1990, it was found that one of the principal investigators in one of the 489 participating institutions had falsified records. A formal investigation was started in 1991, and by 1993, it was determined that the investigator was guilty of scientific misconduct. Although reanalysis suggested that there was no change in the resulting recommendations, patients and their families were overwrought. Management of conflicts of interest in research may include disclosure of financial interest, having independent reviewers monitor the research, disqualifying certain investigators from research, or prohibiting relationships that create the condition of conflict of interest.^[175]

Another form of this problem has been in the relationships among academic researchers and pharmaceutical company-sponsored clinical trials. Clinical trials that report impassionate, complete results drive clinical practice and policy. Editors of major journals have suggested that standards for acceptable research relationships with industry for clinical trials include participation in trial development, the right to examine the raw data independently, and the right to submit a manuscript without the sponsor's approval.^[178]