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Chapter 6: AMA Ethical Opinions on CME

Introduction
Principles of Medical Ethics
AMA Ethical Opinion 9.011: Continuing Medical Education

AMA Ethical Opinion 8.061: Gifts to Physicians from Industry

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Introduction

More than any other medical organization in the United States, the American Medical Association represents physicians to society at large. To foster professionalism among its members, but also all physicians, the AMA has developed Principles of Medical Ethics and a set of Current Opinions of the Council on Ethical and Judicial Affairs. These have emerged, over the years, as an important source of guidance for responsible professional medical behavior. The full set of Current Opinions are the primary compendium of medical professional value statements in the United States and have significant impact. As such, they have been adopted by other medical specialty societies and are looked to by judges and attorneys as a predicate for legal advocacy and decision making in matters of health care law and litigation. They have also been used extensively by state licensing jurisdictions, and other official bodies, as guidelines for ethical physician behavior.

The AMA's Council on Ethical and Judicial Affairs is the body that enunciates the Current Opinions for the Association and recommends changes to the AMA Principles of Medical Ethics. It was initially formed in 1847 as the Judicial Council of the AMA, and major revisions were accomplished in 1903, 1912, 1947, 1956, and 1980. In 1985, the Judicial Council became the Council on Ethical and Judicial Affairs, which consists of nine members, one member of which is appointed annually by the President of the AMA with concurrence of the House of Delegates, the AMA's governing body. Council members serve a term of seven years and must resign all other positions held by them in the Association upon election to the Council. In effect, the Council on Ethical and Judicial Affairs (CEJA) is the "Supreme Court" of the AMA, with the responsibility to interpret the Principles of Medical Ethics, the Constitution, Bylaws, and Rules of the Association, and to investigate general ethical conditions and all matters pertaining to the relations of physicians to one another or to the public.

Reprinted here for the understanding of the continuing medical education community are the Principles of Medical Ethics and two of the Current Opinions, Ethical Opinion 8.061: Gifts to Physicians from Industry and Ethical Opinion 9.011: Continuing Medical Education. It is key to point out that the AMA speaks to individual physicians with these ethical statements, although other groups and organizations may from time to time incorporate any or all of these in other organizational ethical codes.


For additional information on the AMA Ethical Opinions, contact the Council on Ethical and Judicial Affairs in care of

Linda Emanuel, MD
Vice President
Ethics Standards Division
American Medical Association
515 North State Street
Chicago, IL 60610
312 464-5659



Principles of Medical Ethics

Preamble
The medical profession has long subscribed to a body of ethical statements developed primarily for the benefit of the patient. As a member of this profession, a physician must recognize responsibility not only to patients but also to society, to other health professionals, and to self. The following Principles adopted by the American Medical Association are not laws but standards of conduct that define the essentials of honorable behavior for the physician.

  1. A physician shall be dedicated to providing competent medical service with compassion and respect for human dignity.
  2. A physician shall deal honestly with patients and colleagues and strive to expose those physicians deficient in character or competence, or who engage in fraud or deception.
  3. A physician shall respect the law and also recognize a responsibility to seek changes in those requirements that are contrary to the best interests of the patient.
  4. A physician shall respect the rights of patients, colleagues, and other health professionals, and shall safeguard patient confidences within the constraints of the law.
  5. A physician shall continue to study, apply and advance scientific knowledge, make relevant information available to patients, colleagues, and the public, obtain consultation, and use the talents of other health professionals when indicated.
  6. A physician shall, in the provision of appropriate patient care, except in emergencies, be free to choose whom to serve, with whom to associate, and the environment in which to provide medical services.
  7. A physician shall recognize a responsibility to participate in activities contributing to an improved community.

AMA Ethical Opinion 9.011: Continuing Medical Education

Physicians should strive to further their medical education throughout their careers, for only by participating in continuing medical education (CME) can they continue to serve patients to the best of their abilities and live up to professional standards of excellence. Fulfillment of mandatory state CME requirements does not necessarily fulfill the physician's ethical obligation to maintain his or her medical expertise.

Attendees

  1. The physician choosing among CME activities should assess their educational value and select only those activities that are of high quality and appropriate for the physician's educational needs. When selecting formal CME activities, the physician should, at a minimum, choose only those activities that:
    1. Are offered by sponsors accredited by the Accreditation Council for Continuing Medical Education (ACCME), the American Academy of Family Physicians (AAFP), or a state medical society
    2. Contain information on subjects relevant to the physician's needs
    3. Are responsibly conducted by qualified faculty
    4. Conform to Opinion 8.061: Gifts to Physicians from Industry
  • The educational value of the CME conference or activity must be the primary consideration in the physician's decision to attend or participate. Though amenities unrelated to the educational purpose of the activity may play a role in the physician's decision to participate, this role should be secondary to the educational content of the conference.
  • Physicians should only claim credit commensurate with the actual time spent attending a CME activity or in studying a CME enduring material.
  • Attending promotional activities put on by industry or their designees is not unethical as long as the conference conforms to Opinion 8.061: Gifts to Physicians from Industry and is clearly identified as promotional to all participants.

    Faculty

    1. Physicians serving as presenters, moderators, or other faculty at a CME conference should ensure that:
      1. Research findings and therapeutic recommendations are based on scientifically accurate, up-to-date information and are presented in a balanced, objective manner.
      2. The content of their presentation is not modified or influenced by representatives of industry or other financial contributors, and they do not employ materials whose content is shaped by industry. Faculty may, however, use scientific data generated from industry-sponsored research, and they may also accept technical assistance from industry in preparing slides or other presentation materials, as long as this assistance is of only nominal monetary value and the company has no input in the actual content of the material.
    2. When invited to present at non-CME activities that are primarily promotional, faculty should avoid participation unless the activity is clearly identified as promotional in its program announcements and other advertising.
    3. All conflicts of interest or biases, such as financial connection to a particular commercial firm or product, should be disclosed by faculty members to the activity's sponsor and to the audience. Faculty may accept reasonable honoraria and reimbursement for expenses in accordance with Opinion 8.061: Gifts to Physicians from Industry.

    Sponsors

    1. Physicians involved in the sponsorship of CME activities should ensure that:
      1. The program is balanced, with faculty members presenting a broad range of scientifically supportable viewpoints related to the topic at hand
      2. Representatives of industry or other financial contributors do not exert control over the choice of moderators, presenters, or other faculty, or modify the content of faculty presentations. Funding from industry or others may be accepted in accordance with Opinion 8.061: Gifts to Physicians from Industry.
    2. Sponsors should not promote CME activities in a way that encourages attendees to violate the guidelines of the Council on Ethical and Judicial Affairs, including Opinion 8.061: Gifts to Physicians from Industry, or the principles established for the American Medical Association's Physician Recognition Award. CME activities should be developed and promoted consistent with guideline 2 for attendees.
    3. Any non-CME activity that is primarily promotional must be identified as such to faculty and participants, both in its advertising and at the conference itself. (Opinion 9.011 is derived from Principles I and V of the Principles of Medical Ethics.)

    AMA Ethical Opinion 8.061: Gifts to Physicians from Industry

    Many gifts given to physicians by companies in the pharmaceutical, device, and medical equipment industries serve an important and socially beneficial function. For example, companies have long provided funds for educational seminars and conferences. However, there has been growing concern about certain gifts from industry to physicians. Some gifts that reflect customary practices of industry may not be consistent with principles of medical ethics. To avoid the acceptance of inappropriate gifts, physicians should observe the following guidelines:

    1. Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value. Accordingly, textbooks, modest meals, and other gifts are appropriate if they serve a genuine educational function. Cash payments should not be accepted.
    2. Individual gifts of minimal value are permissible as long as the gifts are related to the physician's work (e.g., pens and note pads).
    3. Subsidies to underwrite the costs of continuing medical education conferences or professional meetings can contribute to the improvement of patient care and therefore are permissible. Since the giving of a subsidy directly to a physician by a company's representative may create a relationship that could influence the use of the company's products, any subsidy should be accepted by the conference's sponsor who in turn can use the money to reduce the conference's registration fee. Payments to defray the costs of a conference should not be accepted directly from the company by the physicians attending the conference.
    4. Subsidies from industry should not be accepted directly or indirectly to pay for the costs of travel, lodging, or other personal expenses of physicians attending conferences or meetings, nor should subsidies be accepted to compensate for the physician's time. Subsidies for hospitality should not be accepted outside of modest meals or social events held as a part of a conference or meeting. It is appropriate for faculty at conferences or meetings to accept reasonable honoraria and to accept reimbursement for reasonable travel, lodging, and meal expenses. It is also appropriate for consultants who provide genuine services to receive reasonable compensation and to accept reimbursement for reasonable travel, lodging, and meal expenses. Token consulting or advisory arrangements cannot be used to justify the compensation of physicians for their time or their travel, lodging and other out-of-pocket expenses.
    5. Scholarship or other special funds to permit medical students, residents, and fellows to attend carefully selected educational conferences may be permissible as long as the selection of students, residents, or fellows who will receive the funds is made by the academic or training institution.
    6. No gifts should be accepted if there are strings attached. For example, physicians should not accept gifts if they are given in relation to the physician's prescribing practices. In addition, when companies underwrite medical conferences or lectures other than their own, responsibility for and control over the selection of content, faculty, educational methods, and materials should belong to the organizers of the conferences or lectures.

    Following is the report of the Council on Ethical and Judicial Affairs that was presented with the Ethical Opinion to the House of Delegates of the AMA on December 3, 1990. This report provides the reasoning behind the guidelines. In addition, the Council prepared a number of interpretations in response to representative questions about the Opinion when it was issued in 1990. These are reprinted again, because they enunciate circumstances and situations that are still relevant and demonstrate how the Ethical Principles are applied in a daily practice setting.

    The Report

    While relationships between industry and the medical community have resulted in important benefits for patient care, there has been growing concern about the potential negative consequences of the relationship. In particular, commentators have increasingly questioned the appropriateness of some of the gifts that are given to physicians by companies in the pharmaceutical, device, medical equipment, and other-health-care industries. Many gifts serve an important and socially beneficial function. For example, companies have long provided funds for educational programs and facilities. Some gifts, however, may have inappropriate effects, and are, therefore, cause for concern. This report discusses the ethical issues raised by the practice of industry gift giving and proposes guidelines for physicians to distinguish appropriate from inappropriate gifts.

    Gift-Giving Practices Gift giving by industry can take many forms. Typically, companies provide physicians with ballpoint pens, penlights, note pads, and other inexpensive items upon which is printed the name of the company or one of its products. Hospital residents are often treated to lunches or dinners by sales representatives. Companies also sponsor medical conferences that have been developed by hospitals, medical schools, or professional associations. Their sponsorship often takes the form of a speaker, general support, or specific underwriting grants, and includes hospitality suites, dinners, and cash payments to registrants to defray the costs of attending the conference. In some cases, companies will pay the full cost for a physician to attend a conference in another state or country and offer to pay for additional days of vacation at the conference site.

    Some companies sponsor conferences with speakers who are selected by the company and discuss the company's products. These conferences are typically held at attractive locations, and physicians are flown in with their spouses for a weekend of presentations, recreation, and entertainment, all at company expense. Often, a company will direct its invitations to physicians who are viewed as leading practitioners by other physicians in their community. The companies recognize that practices adopted by these "Leaders" are generally followed by their peers. Companies schedule individual speakers to speak to groups of physicians over dinner at no cost to the physicians, and some companies will pay $100 to each physician who attends the dinner to compensate for the physician's time (1). It has been reported that a few companies have also given physicians gifts or cash payments for every patient who was started on a particular drug (2,3).

    Some of these practices are entirely ethical and beneficial to patients, and not all companies engage in them. In addition, the rules regarding the propriety of the practices have not been clear. Recognizing the lack of clarity, the medical profession and the pharmaceutical industry have been supportive of change. The Task Force on Pharmaceutical Industry/CME Cooperation, chaired by the AMA, is now actively reviewing the guidelines for industry support of CME.

    Ethical Concerns Regarding Gift Giving

    Industry invests in promotional activities because promotions increase sales. As one commentator has observed, no company "gives away its shareholders' money in an act of disinterested generosity" (4). There is no evidence that physicians knowingly or intentionally compromise their patients' care as a result of gifts from industry. Nevertheless, the practice of gift giving may mobilize subtle influences that can result in practice patterns based on considerations that go beyond scientific knowledge and patient needs.

    In a recent article examining the cultural phenomenon of gift giving, researchers observed that the giving and accepting of a gift can lead to important social relationships with real obligations (5). By accepting a gift, an individual "assumes certain social duties, such as grateful conduct, grateful use, and reciprocation. Salespersons have long recognized the social implications of gift giving; surveys indicate that gifts to potential buyers are given in the belief that gifts tend to obligate their recipients, and that they are therefore useful for increasing sales (6).

    Physicians do not respond to gifts from industry by giving gifts in return. However, there are other ways to reciprocate and express gratitude. The physician may be more responsive in granting interviews to sales representatives and may, on the basis of the information presented, decide to use a new drug or device on a trial basis with his/her patients. In a study of industry funding for CME, researchers found a relationship between the source of funding and physician prescribing practices. The study examined prescribing patterns of physicians both before and after they attended one of three CME courses. The courses in the study met the following criteria: A single drug company was the major financial supporter of the course; the course topic was directly related to a single class of drugs with at least three drugs in the class; and the drugs were essentially similar in terms of benefits, side effects, and costs. While after each course there were increases in the prescribing of all drugs in the class, the greatest effect occurred for the drug whose company was the major financial supporter of the course (7).

    Gift giving can also influence physician practices because a person's judgment about a product is affected by considerations other than the product's quality. When a physician receives a gift from a company's sales representative, the physician may associate his/her feelings about the gift or the sales representative with his/her feelings about the company's products. A recent study indicates that the receipt of a gift may have an important effect on a potential customer's perception of a product, even when the gift is a small one (8).

    Gifts may affect a physician's education regarding new developments in medicine by influencing the physician's choice of medical conferences. Physicians frequently rely upon medical conferences to update their knowledge and expertise. Among the available conferences, physicians have time to attend a limited number of conferences and industry can make certain conferences more attractive by subsidizing the costs of attending. Companies will direct their subsidies at conferences that provide the most favorable view of their products.

    Through the presentations of sales representatives to physicians, companies tend to emphasize the results of clinical research supporting both the efficacy and the lower cost of their products as compared to competing products of other companies. Physicians, in prescribing for their patients, therefore, must ensure that they are knowledgeable about the full range of research regarding the benefits and possible adverse reactions to pharmaceutical and other products, and they must provide their patients with full information on risks and potential complications. The continued use of new or established products must be based on the response of the individual patient and the preponderance of evidence from all clinical trials, as well as neutral sources of information such as the AMA's widely used Drug Evaluations. Gifts should have no part in influencing these decisions.

    The concern about undue influence from a gift is particularly strong when the gift comes with strings attached. A company that donates funds to underwrite a CME conference may want a role in shaping the program, for instance by selecting speakers from its own panel of experts, selected for their knowledge and experience in the use of the company's products. These experts may show bias with regard to use of the company's products, thereby undermining the objectivity and impartiality of the educational activity (9).

    While there is little evidence that physicians consciously make practice decisions on the basis of factors other than a product's clinical properties and the patient's particular needs, some research suggests that physicians unknowingly may be influenced by promotional techniques. In a study of physicians prescribing of propoxyphene (Darvon) for analgesia and cerebral vasodilators for senile dementia, researchers found that physicians, in substantial numbers, were likely to use these drugs in situations that could not be justified by evidence in the clinical literature (10). Instead, these physicians held beliefs about the efficacy of the drugs that were consistent with information found in commercial advertisements for the drugs.

    In describing these potential problems with gifts to physicians, the Council has not lost sight of the need for physicians to receive the broadest possible exposure to new and different health-care products and their clinical applications. Unquestionably, patients have obtained some benefit even from gifts and other practices that may, on balance, be too substantial to be considered appropriate. For some physicians, the events and conferences described above have been a means through which they stay abreast of rapidly occurring advances in medicine, and hear and interact with noted colleagues discussing new products and developments in their field. These events have been of genuine educational value to this extent, and they have expanded the universe of clinicians receiving research support from pharmaceutical and other companies.

    Appearance of Impropriety

    Even when gifts from industry have no effect on a physician's practices, there may be a public impression of impropriety, especially if the gifts are of substantial value. The public trust that physicians are dedicated foremost to the welfare of their patients may be undermined when there is a possibility that the choice of a drug, device, or other product is influenced by the fact that the physician had received a gift from the company that manufactures the product. For example, when companies schedule their own conferences at resorts and pay for physicians and their spouses to attend for a weekend that includes only a few hours of lectures and many hours of recreation, lavish meals, and expensive entertainment, it is difficult to view the conference as serving a legitimate educational purpose (11).

    Strict limits on the acceptance of gifts to avoid even the appearance of impropriety have been adopted in other contexts. Federal government employees, including physicians at Veterans Affairs hospitals, may not accept gifts from companies whose products or services they are using (12), and federal judges may not accept gifts from persons whose interests have come, or are likely to come, before the judge (13). Companies in industry also generally impose limits on the acceptance of gifts by their employees. In a survey of manufacturing firms, a researcher found that 50 percent of the firms did not permit their employees to accept gifts other than pens, pads, or items of comparable value. Twenty-four percent of the firms permitted gifts up to $50 in value to be accepted but only on an occasional basis (14). In addition, in a survey of purchasing agents for industrial companies, the agents agreed that it is unethical to accept entertainment, tickets, gifts, or other favors from sellers (15).

    The appearance of impropriety may also arise because of the magnitude of company spending on promotional activities, including gifts. According to one estimate, pharmaceutical companies spent at least $2.5 billion per year for all their promotional activities in 1988 (16). Specific data on what portion of this can be attributed to gifts to physicians is not available beyond estimates that $200 million is spent annually by the pharmaceutical industry for medical education (17). It is not clear how much is spent on promotional activities for physicians by companies that manufacture or distribute devices and medical equipment. According to data released after the Council's report was issued, pharmaceutical companies spend at least $5 billion a year on marketing activities. Eighteen of the major pharmaceutical companies spent $165 million on symposia and other gifts in 1988, a five-fold increase since 1975, after adjusting for inflation (18).

    Costs of Gifts

    The costs of gifts from industry to physicians are ultimately passed on to the public. In effect, then, patients may be paying for a benefit that, in some cases, is captured primarily by their physicians. Physicians should not accept inappropriate gifts because the cost is ultimately subsidized by patients.

    The Council on Ethical and Judicial Affairs recognizes that many gifts from industry to physicians result in significant benefits to patients. For example, books and conferences contribute to the education of physicians, and meals at medical meetings or conferences provide a forum for colleagues to exchange information. These kinds of gifts can, therefore, be appropriate, depending on the extent to which the gift serves a function beneficial to patient care, and on whether the same benefits can be realized through less costly promotional activities.

    Guidelines and Interpretations

    General Questions

    When do the interpretations take effect?

    The guidelines and interpretations are in full force. However, the interpretations do not apply retroactively to programs that have been planned in a good faith belief that they complied with the guidelines.

    Do the guidelines apply only to pharmaceutical, device, and equipment manufacturers?

    "Industry" includes all "proprietary health-related entities that might create a conflict of interest," as recommended by the American Academy of Family Physicians.

    Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value. Accordingly, textbooks, modest meals, and other gifts are appropriate if they serve a genuine educational function. Cash payments should not be accepted.

    May physicians accept Gram's stain test kits, stethoscopes, or other diagnostic equipment?

    Diagnostic equipment primarily benefits the patient. Hence, such gifts are permissible as long as they are not of substantial value. In considering the value of the gift, the relevant measure is not the cost to the company of providing the gift. Rather, the relevant measure is the cost to the physician if the physician purchased the gift on the open market.

    May companies invite physicians to a dinner with a speaker and donate $100 to a charity or medical school on behalf of the physician?

    There are positive aspects to the proposal. The donations would be used for a worthy cause, and the physicians would receive important information about patient care. However, there is a direct personal benefit to the physician as well. An organization that is important to the physician and one that the physician might have ordinarily felt obligated to make a contribution to receives financial support as a result of the physician's decision to attend the meeting. On balance, physicians should make their own judgment about these inducements. If the charity is predetermined without the physician's input, there would seem to be little problem with the arrangement.

    May contributions to a professional society's general fund be accepted from industry?

    The guidelines are designed to deal with gifts from industry that affect, or could appear to affect, the judgment of individual practicing physicians. In general, a professional society should make its own judgment about gifts from industry to the society itself.

    When companies invite physicians to a dinner with a speaker, what are the relevant guidelines?

    First, the dinner must be a modest meal. Second, the guideline does allow gifts that primarily benefit patients and that are not of substantial value. Accordingly, textbooks and other gifts that primarily benefit patient care, and that have a value to the physician in the general range of $100, are permissible.

    May physicians accept vouchers that reimburse them for uncompensated care they have provided?

    No. Such a voucher would result directly in increased income for the physician.

    May physicians accumulate "points" by attending several educational or promotional meetings and then choose a gift from a catalogue of educational options?

    This guideline permits gifts only if they are not of substantial value. It would be inappropriate if accumulation of points would result in physicians receiving a substantial gift by combining insubstantial gifts over a relatively short period of time.

    May physicians accept gift certificates for educational materials when attending promotional or educational events?

    The Council views gift certificates as a gray area that is not, per se, prohibited by the guidelines. Medical textbooks are explicitly approved as gifts under the guidelines. A gift certificate for educational materials, ie, for the selection by the physician from an exclusively medical textbook catalogue, would not seem to be materially different. The issue is whether the gift certificate gives the recipient such control as to make the certificate similar to cash. As with charitable donations, pre-selection by the sponsor removes any question. It is up to the individual physician to make the final judgment.

    Individual gifts of minimal value are permissible as long as the gifts are related to the physician's work (eg, pens and note pads).

    Subsidies to underwrite the costs of CME conferences or professional meetings can contribute to the improvement of patient care and, therefore, are permissible. Since the giving of a subsidy directly to a physician by a company's sales representative may create a relationship that could influence the use of the company's products, any subsidy should be accepted by the conference's sponsor, who in turn can use the money to reduce the conference's registration fee. Payments to defray the costs of a conference should not be accepted directly from the company by the physicians attending the conference.

    Are conference subsidies from the educational division of a company covered by the guidelines?

    Yes. When the Council says "any subsidy," it would not matter whether the subsidy comes from the sales division, the educational division, or some other section of the company.

    May a company or its intermediary send physicians a check or voucher to offset the registration fee at a specific conference or a conference of the physician's choice?

    Physicians should not directly accept checks or certificates that would be used to offset registration fees. The gift of a reduced registration should be made across the board and through the accredited sponsor.

    Subsidies from industry should not be accepted directly or indirectly to pay for the costs of travel, lodging, or other personal expenses of physicians attending conferences or meetings, nor should subsidies be accepted to compensate for the physicians' time. Subsidies for hospitality should not be accepted outside of modest meals or social events held as a part of a conference or meeting. It is appropriate for faculty at conferences or meetings to accept reasonable honoraria and to accept reimbursement for reasonable travel, lodging, and meal expenses. It is also appropriate for consultants who provide genuine services to receive reasonable compensation and to accept reimbursement for reasonable travel, lodging, and meal expenses. Token consulting or advisory arrangements cannot be used to justify compensating physicians for their time or their travel, lodging, and other out-of-pocket expenses.

    If a company invites physicians to visit its facilities for a tour or to become educated about one of its products, may the company pay travel expenses and honoraria? This question has arisen in the context of a rehabilitation facility that wants physicians to know of its existence so that they may refer their patients to the facility. It has also arisen in the context of surgical device or equipment manufacturers who want physicians to become familiar with their products.

    In general, travel expenses should not be reimbursed, nor should honoraria be paid for the visiting physician's time since the presentations are analogous to a pharmaceutical company's educational or promotional meetings. The Council recognizes that medical devices, equipment, and other technologies may require, in some circumstances, special evaluation or training in proper usage that cannot practicably be provided except on site. Medical specialties are in a better position to advise physicians regarding the appropriateness of reimbursement with regard to these trips. In cases where the company insists on such visits as a means of protection from liability for improper usage, physicians and their specialties should make the judgment. In no case would honoraria be appropriate, and any travel expenses should be only those strictly necessary.

    If the company invites physicians to visit its facilities for review and comment on a product, to discuss their independent research projects, or to explore the potential for collaborative research, may the company pay travel expenses and an honorarium?

    If the physician is providing genuine services, reasonable compensation for time and travel expenses can be given. However, token advisory or consulting arrangements cannot be used to justify compensation.

    May a company hold a sweepstakes for physicians in which five entrants receive a trip to the Virgin Islands or airfare to the medical meeting of their choice?

    No. The use of a sweepstakes or raffle to deliver a gift does not affect the permissibility of the gift. Since the sweepstakes is not open to the public, the guidelines apply in full force.

    If a company convenes a group of physicians to recruit clinical investigators or convenes a group of clinical investigators for a meeting to discuss their results, may the company pay for their travel expenses?

    Expenses may be paid if the meetings serve a genuine research purpose. One guide to their propriety would be whether the NIH conducts similar meetings when it sponsors multicenter clinical trials. When travel subsidies are acceptable, the guidelines emphasize that they be used to pay only for "reasonable" expenses. The reasonableness of expenses would depend on a number of considerations. For example, meetings are likely to be problematic if overseas locations are used for exclusively domestic investigators. It would be inappropriate to pay for recreation or entertainment beyond the kind of modest hospitality described in this guideline.

    How can a physician tell whether there is a "genuine research purpose?"

    A number of factors can be considered. Signs that a genuine research purpose exists include the facts that there are: (1) a valid study protocol, (2) recruitment of physicians with appropriate qualifications or expertise, and (3) recruitment of an appropriate number of physicians in light of the number of study participants needed for statistical evaluation.

    May a company compensate physicians for their time and travel expenses when they participate in focus groups?

    Yes. As long as the focus groups serve a genuine and exclusive research purpose and are not used for promotional purposes, physicians may be compensated for time and travel expenses. The number of physicians used in a particular focus group, or in multiple focus groups, should be an appropriate size to accomplish the research purpose, but no larger.

    Do the restrictions on travel, lodging, and meals apply to educational programs run by medical schools, professional societies, or other accredited organizations funded by industries, or do they apply only to programs developed and run by industry?

    The restrictions apply to all conferences or meetings that are funded by industry. The Council drew no distinction on the basis of the organizer of the conference or meeting. The Council felt that the gift of travel expenses is too substantial even when the conference is run by a non-industry sponsor. (Industry includes all "proprietary health-related entities that might create a conflict of interest," as recommended by the American Academy of Family Physicians.)

    May company funds be used for travel expenses and honoraria of bona fide faculty at educational meetings?

    This guideline draws a distinction between attendees and faculty. As was stated, "It is appropriate for faculty at conferences or meetings to accept reasonable honoraria and to accept reimbursement for reasonable travel, lodging, and meal expenses."

    Companies need to be mindful of the guidelines of the ACCME. According to those guidelines, funds from a commercial source should be in the form of an educational grant made payable to the CME sponsor for the support of programming."

    May travel expenses be reimbursed for physicians presenting a poster or a "free paper" at a scientific conference?

    Reimbursement may be accepted only by bona fide faculty. The presentation of a poster or a free paper does not, by itself, qualify a person as a member of the conference faculty for purposes of these guidelines.

    When a professional association schedules a long range planning meeting, is it appropriate for industry to subsidize the travel expenses of the meeting participants?

    The guidelines are designed to deal with gifts from industry that affect, or could appear to affect, the judgment of individual practicing physicians. In general, a professional society should make its own judgment about gifts from industry to the society itself.

    May CME conferences be held in the Bahamas, Europe, or South America?

    There are no restrictions on the location of conferences, as long as the attendees are paying their own travel expenses.

    May travel expenses be accepted by physicians who are being trained as speakers or faculty for educational conferences and meetings?

    In general, no. If a physician is presenting as an independent expert at a CME event, both the training and its reimbursement raise questions about independence. In addition, the training is a gift because the physician's role is generally more analogous to that of an attendee than a participant. Speaker training sessions can be distinguished from meetings with leading researchers, sponsored by a company, designed primarily for an exchange of information about important developments or treatments, including the sponsor's own research, for which reimbursement for travel may be appropriate.

    What kinds of social events during conferences and meetings may be subsidized by industry?

    Social events should satisfy three criteria. First, the value of the event to the physician should be modest. Second, the event should facilitate discussion among attendees and/or discussion between attendees and faculty. Third, the educational part of the conference should account for a substantial majority of the total time accounted for by the educational activities and social events together. Events that would be viewed (as in the succeeding question) as lavish or expensive should be avoided. But modest social activities that are not elaborate or unusual are permissible, eg, inexpensive boat rides, barbecues, entertainment that draws on the local performers. In general, any such events that are a part of the conference program should be open to all registrants.

    May a company rent an expensive entertainment complex for an evening during a medical conference and invite the physicians attending the conference?

    No. The guidelines permit only modest hospitality.

    If physicians attending a conference engage in interactive exchange, may their travel expenses be paid by industry?

    No. Mere interactive exchange would not constitute genuine consulting services.

    If a company schedules a conference and provides meals for the attendees that fall within the guidelines, may the company also pay the costs of the meals for spouses?

    If a meal falls within the guidelines, then the physician's spouse may be included.

    May companies donate funds to sponsor a professional society's charity golf tournament?

    Yes. But it is recommended that physicians participating in the event also make a charitable contribution.

    If a company invites a group of consultants to a meeting and a consultant brings a spouse, may the company pay the costs of lodging or meals of the spouse? Does it matter if the meal is part of the program for the consultants?

    Since the costs of having a spouse share a hotel room or join a modest meal are nominal, it is permissible for the company to subsidize those costs. However, if the total subsidies become substantial, then they become unacceptable.

    Scholarship or other special funds to permit medical students, residents, and fellows to attend carefully selected educational conferences may be permissible as long as the selection of students, residents, or fellows who will receive the funds is made by the academic or training institution.

    When a company subsidizes the travel expenses of residents to an appropriately selected conference, may the residents receive the subsidy directly from the company?

    Funds for scholarships or other special funds should be given to the academic departments or the accredited sponsor of the conference. The disbursement of funds can then be made by the departments or the conference sponsor.

    What is meant by "carefully selected educational conferences"?

    The intent of the phrase, "carefully selected educational conferences," is to ensure that financial hardship does not prevent students, residents, and fellows from attending major educational conferences. For example, we did not want to deny cardiology fellows the opportunity to attend the annual scientific meeting of the American College of Cardiology, or orthopedic surgery residents the opportunity to attend the annual scientific meeting of the American Academy of Orthopaedic Surgeons. However, it was not the intent of the guideline to permit reimbursement of travel expenses in other circumstances, such as when conferences or symposia are designed specifically for students, residents, or fellows.

    Accordingly, "carefully selected educational conferences" should be interpreted as follows: Funds may be used for the reasonable travel and lodging expenses of students, residents, and fellows to attend the major educational, scientific, or policy making meetings of national, regional, or specialty medical associations.

    The Council recognizes that there may be some exceptional conferences for all physicians or even for just students, residents, or fellows that do not fall within this definition of carefully selected educational conferences but that meet the spirit of the above outlined guideline. Accordingly, the Council will consider proposals for travel and lodging subsidies for such conferences on a case-by-case basis, and it will grant approval to those that meet the spirit of the guideline.

    No gifts should be accepted if there are strings attached. For example, physicians should not accept gifts if they are given in relation to the physician s prescribing practices. In addition, when companies underwrite medical conferences or lectures other than their own, responsibility for, and control over, the selection of content, faculty, educational methods, and materials should belong to the organizers of the conferences or lectures.

    May companies send their top prescribers, purchasers, or referrers on cruises?

    No. There can be no link between prescribing or referring patterns and gifts. In addition, travel expenses, including cruises, are not permissible.

    May the funding company itself develop the complete educational program that is sponsored by an accredited CME sponsor?

    No. The funding company may finance the development of the program through its grant to the sponsor, but the accredited sponsor must have responsibility and control over the content and faculty of conferences, meetings, or lectures. Neither the funding company nor an independent consulting firm should develop the complete educational program for approval by the accredited sponsor.

    How much input may a funding company have in the development of a conference, meeting, or lectures?

    The guidelines of the ACCME on commercial support of CME address this question.


    References

    1. Council on Ethical and Judicial Affairs. Gifts to physicians from industry JAMA. 1991;265:501.

    2. The relationship between physicians and the pharmaceutical industry: a report of the Royal College of Physicians. JR Coll Physicians Lond. 1986;20:235-240.

    3. Graves J. Frequent-flyer programs for drug prescribing (letter to the editor). N Engl J Med. 1987;317:252.

    4. Rawlins MD. Doctors and the drug makers. Lancet. 1984;2:276-278.

    5. Chren MM, Landefeld CS, Murray TH. Doctors, drug companies, and gifts. JAMA. 1989;262:3448-3451.

    6. Hite RE, Bellizzi JA. Salespeople's use of entertainment and gifts. Industrial Marketing Management. 1987;16:279-285.

    7. Bowman MA, Pearle DL. Changes in drug prescribing patterns related to commercial company funding of continuing medical education. J Continuing Education Health Professions. 1988,8:13-20.

    8. Shama A, Thompson JK, Gifts build goodwill and market share. J Retail Banking. 1989;11:55-59.

    9. Goldfinger SE. A matter of influence. New Engl J Med. 1987;316:1408-1409.

    10. Avorn J, Chen M, Hartley R. Scientific versus commercial sources of influence on the prescribing behavior of physicians. Am J Med,. 1982,73:4-8.

    11. Nelson JC. A snorkel, a 5-iron, and a pen. JAMA.1990;264:742.

    12. Executive Order No. 11,222, reprinted in 18 U.S.C. 201 appendix

    13. American Bar Association. Model Code of Professional Responsibility and Code of Judicial Conduct. Chicago, Ill: ABA Press;1986:126.

    14. Bird MM. Gift-giving and gift-taking in industrial companies. Industrial Marketing Management. 1989;18:91-94.

    15. Browning J, Zabriskie NB. How ethical are industrial buyers? Industrial Marketing Management 1983;12:219-224.

    16. Wilkes MS, Shuchman M. Pitching doctors. New York Times Magazine. November 1989.

    17. American College of Physicians. Physicians and the pharmaceutical industry. Ann Intern Med. 1990;112:624-626.

    18. Randall T. Kennedy hearings say no more free lunch-or much else-from drug firms. JAMA. 1991;265:440, 442.


    In 1991, the AMA's House of Delegates adopted Substitute Resolution 64, which addressed certain unethical behaviors of physicians with regard to continuing medical educational (CME). The House requested the AMA to develop and publish guidelines to assist physicians in identifying CME of high quality responsive to their needs (Physician Commitment to Lifelong Learning), and to promulgate ethical principles regarding the responsibilities of physicians to participate in CME programs for which they claim for CME recognition, credit, or other purposes. The Council on Ethical and Judicial Affairs responded to the resolution with the following Opinion 9.011, derived from Principles I and V of the Principles of Medical Ethics.


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