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January 19, 2000

Interactions Between Physicians and the Health Care Technology Industry

Author Affiliations

Author Affiliation: Council on Ethical and Judicial Affairs, American Medical Association, Chicago, Ill.

JAMA. 2000;283(3):391-393. doi:10.1001/jama.283.3.391

My first formal contact with the health care technology industry was the black bag I received from a leading pharmaceutical company when I entered medical school. There were also gifts, such as penlights, notepads, and a multitude of drug samples, all with the pharmaceutical company's name clearly identified on the gift. Except for the occasional meeting with a pharmaceutical representative to discuss the advantages of a company's latest drug, that was the extent of our tangible relationship. The company name and product probably did achieve more recognition as a result. This, of course, is the lasting impact the company seeks.1

Representatives from the health care industry can be a valuable information resource for physicians.2,3 The potential for this information to help patients creates a responsibility on the part of the industry to share pertinent knowledge with physicians so that it can be used to raise the level of health care delivery.4-6 Even though it may be desirable to encourage information sharing, relationships between physicians and industry raise concerns about whether the patient's best interests will come into conflict with industry's focus on the bottom line. Physicians should not take as absolute everything they are told by industry representatives and should become cognizant of the potential conflicts created by the increasing level of sophistication in the detailing techniques used by these individuals.7,8

Medical education generally can be divided into the categories of noncurricular and curricular activities. Noncurricular education may include performing a new procedure or prescribing a new medication under the guidance of a more experienced physician. Curricular learning may involve attendance at a several-day-long seminar, at grand rounds, or at mortality and morbidity conferences. Sources of medical information may come from a professional peer or a world expert in the medical field. However, the source of information often comes from outside the medical profession. It is in this latter area that there has been a great deal of controversy recently.

Until the early 1980s, pharmaceutical and medical device companies relied on providing information about a particular product and perhaps even small gifts to promote goodwill and name recognition.9 With the advent of more lavish gifts, the practices became akin to manipulation, shifting the focus from providing information to providing incentives.10 Extreme examples of these techniques reportedly included paid vacations for physicians and even airline travel miles, which were awarded based on the number of prescriptions written.11 In addition, continuing medical education (CME) seminars about products were paid for and speakers were chosen by the company.12-14

Congress developed an interest in these activities and began to investigate them in the early 1990s.15 In the hope of averting government intervention, the American Medical Association (AMA) developed guidelines that addressed these practices; these guidelines also were adopted by the Pharmaceutical Research and Manufacturers of America.

In 1992, the AMA's Council on Ethical and Judicial Affairs (CEJA) first released an opinion16 on this issue, which indicates that gifts to physicians from pharmaceutical and medical device companies primarily should entail a benefit to patients and should not be of substantial value. Meals and entertainment were included in the calculation of substantial value. The council recommended that cash reimbursements should not be accepted directly by physicians but could be used to underwrite the costs of the events physicians might attend to further their CME. In addition, no gifts that were directly or indirectly connected to the physician's prescribing patterns were to be accepted.

In December 1993, CEJA issued an opinion on CME,17 which indicates that the educational value of the activity must be the primary consideration in the physician's decision to attend. The faculty involved in any CME activities were requested to ensure that their presentations not be inappropriately influenced by the event's financial sponsors. All potential conflicts of interest were to be disclosed fully to the audience. Industry sponsors of CME programs were not to exert control over the choice of moderators, presenters, or faculty, or to modify the content of the presentations. Moreover, promotional activities were to be identified clearly as such to the faculty and all the participants.

Initially, the response to the CEJA guidelines was somewhat gratifying, with voluntary adoption of these standards by the medical industry and an apparent diminution of abuses, such as the exchange of airline travel miles for prescriptions, that occurred in the 1980s. In the last several years, however, many of the troubling practices have returned. Industry money and influence has permeated virtually all levels of physician CME in the form of complimentary meals and entertainment, consultation fees, and pseudo-CME courses. A strong case can be made that in a number of situations, peer-reviewers should be more diligent in their evaluation of proposed CME-accredited activities. However, for the most part, the rules established by the Accreditation Council for Continuing Medical Education (ACCME) are complete and respected by the vast majority of the participants. The rules may be open to interpretation, but industry can only provide support for CME-accredited activities. The sponsor always must be an ACCME-accredited facility (eg, a hospital or medical organization). When support does come from industry for CME-accredited activities, this support and any potential conflicts of interest must be disclosed fully to the participants (Dennis Wentz, MD, vice president of medical education, AMA, oral communication, June 1999).18 Pseudo-CME courses, which are not ACCME-approved, actually are a form of advertising shrouded in the veil of CME, because the only options usually presented to the participants are the drugs or devices manufactured by the sponsor of the event.

Unfortunately, while the need for CME for physicians has increased with rapidly expanding technology, the funding from independent sources has decreased proportionately.19 With no other apparent alternative, funding from industry has almost become essential.20 But the demand for these additional resources has led to increasing influence by industry and attempts at control.21 From the point of view of the health care technology industry, this makes a certain amount of sense—why give money or provide other support without reciprocal expectations? After all, these corporations are ultimately responsible to their stockholders who expect a reasonable rate of return on their investments. While this is true of most corporations, these issues raise additional concerns in the health care environment because patients trust that physicians will act only in their best interests. As a result, there may be an expectation that CME will be provided free from industry influence.

The blame for the proliferation of these practices cannot be placed completely on the pharmaceutical industry. The medical profession is also at fault for this change in culture. Routine purchasing of meals for physicians and their staff is a recent example of physician-driven problems. This is a common practice in the business world. Mealtime seemed to be a logical time for visits by industry representatives, because otherwise the visits could interrupt orderly patient care. Initially, the practice started as a convenience, but now it has become so commonplace that it is often expected and in some cases even demanded by physicians. Industry representatives have found themselves unable to gain access to physicians without providing something in return.

As the competition for the physician's time increased, so did the need to increase the benefits. Meals became increasingly lavish. Entertainment, which often included the physician's family, was added as an additional incentive. Consequently, as the demand for pharmaceutical companies' funding increased for CME functions, so did their attempts to control the speakers' presentations and the context of the events they were asked to sponsor. Perhaps the unspoken aim was to buy access and influence, much like political contributions to elected officials.

The concerns raised by these practices are important primarily because they may alter the way medicine is practiced, potentially to the detriment of patients. Company representatives cannot and should not be unbiased in their perspectives. However, physicians can and must be unbiased and devoted to patient care, using whatever product best fits with the clinical circumstances of the patient. Already, physicians must combat the increasing influences of federal constraints and managed care regulations. Inappropriate industry influence may be dangerous because it threatens to compromise physicians' judgment and prescribing patterns based on gifts or monetary incentives about which patients are completely unaware.

Continuing medical education, either through 1-to-1 contact with a representative from industry or formal learning sessions, is, in a sense, the cornerstone around which advanced health care delivery systems are built. Without CME, physicians who are entrusted with the responsibility of offering the best health care available will fall further and further behind. Learning is a responsibility that physicians accept along with their medical degree. That responsibility does not end with the last day of formal training but continues throughout physicians' careers.

Clearly, solutions to these problems cannot come only from organizations that represent the physician community. These are industry-wide problems and need industry-wide solutions. Moreover, it would be unrealistic to propose that all meals, entertainment, or CME funding provided by pharmaceutical companies are unethical. The practice should be judged by degree. The concern is the pursuit of these practices to excess. When the influence created by the meal, the entertainment, or any other activity, in and of itself, has the potential to alter the physician's prescribing patterns rather than the efficacy of the particular product being touted, it should be considered inappropriate. Although it may seem unlikely that a mere dinner could influence a physician's prescribing pattern, the long-term cumulative effect of "buying" physician goodwill in this manner may leave many clinicians uneasy.

In this issue of THE JOURNAL, the exhaustive review by Wazana22 of the peer-reviewed literature published since 1994 on interactions between physicians and the pharmaceutical industry clearly demonstrates the need for concern. The article brings to light the glaring lack of adequate guidelines by a significant percentage of medical organizations and training programs throughout the United States and Canada. Even more troubling, as pointed out by Wazana's review, is the apparent lack of awareness of these adverse influences, even by the participants themselves. This finding underscores the urgency of an industry-wide effort in this area.

During the 1998 annual conference of the National Task Force on CME Provider–Industry Collaboration, held in Washington, DC, a proposal was put forth to convene a task force that would provide more detailed guidelines regarding appropriate and inappropriate practices in this area. However, to develop guidelines, the participants would first have to deal with the issues as they relate to 2 overarching principles of medical ethics. The first is the ethical precept of conflict of interest, in which the bottom line of the health care technology industry must compete with what is in the best interest of the patient population. The second is the full disclosure of these conflicts of interest and how these conflicts potentially influence decisions that ultimately affect delivery of health care services. This task force would bring together representatives from the medical profession, health care technology industry (eg, pharmaceutical companies), and CME, with the charge of developing industry-wide standards of conduct. Participation in a task force may be 1 way to bring fairness to these potentially pervasive practices.

The medical profession and industry must take seriously their obligation to participate in a dialogue that would develop industry-wide standards for the interactions between physicians and health care technology industry company representatives. At the same time, once these standards are developed, the medical profession and the health care technology industry have the same obligations to ensure they are properly enforced.

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