Listed below are background questions and answers about the initiative.
- What's the issue?
- What kinds of gifts are physicians being offered?
- Why do pharmaceutical companies give gifts to physicians?
- What is the AMA's concern?
- What do the guidelines say?
- Why is the AMA getting involved?
- Why is industry participating in the AMA effort?
- Who serves on the working group?
- What is the group trying to accomplish?
- What is the AMA doing to raise awareness?
- How will you enforce compliance with the guidelines?
- Why would physicians want to do this? What's the incentive for them to give up something that benefits them?
- How about sales reps? Why would they want to go along with these guidelines, which limit their ability to promote their products?
- How are sales representatives currently trained to interact with physicians?
- What extra training for sales representatives will take place as part of this effort?
- Can the Working Group really speak legitimately for all of industry and organized medicine?
- What about other ethical guidelines that address this topic? Can a physician or industry representative adhere to other guidelines?
- How is the project being funded?
- How are the funds being utilized?
- What educational resources are you providing?
- For whom are the educational resources designed for?
- What happens when this initiative is over?
- Who will be watching over this to ensure physicians and industry representatives are kept aware of the guidelines into the future?
- How can I help this initiative?
- Where can I go for more information?
1. What's the issue?
Gift giving from the pharmaceutical, device and medical equipment industries to physicians has been a customary practice, and may serve an important and beneficial function for physicians and patients alike. But when gift giving is not practiced within established ethical boundaries, the perception of conflict-of-interest is raised and patient and public trust in physicians and industry may be eroded.
Recent media reports and published studies suggest an increase in gift-giving practices that do not adhere to established ethical guidelines on this subject. The AMA believes that the vast majority of physicians and industry representatives act ethically and play by the rules. But none of us wants the extreme behavior of a few to tarnish the reputation of the vast majority.
2. What kinds of gifts are physicians being offered?
Most are modest items that benefit patients or are related to a physician's work: pens, textbooks, educational materials, and modest meals during which research, treatments and innovations are discussed. These are acceptable under guidelines created by the AMA's Council on Ethical and Judicial Affairs in 1990. The guidelines, issued under CEJA Opinion 8.061, "Gifts to Physicians from Industry," can be found in the AMA's Code of Medical Ethics. But other gifts — lavish dinners, free trips, offers of cash and other inducements — are clearly not in compliance with the guidelines.
3. Why do pharmaceutical companies give gifts to physicians?
Gifts serve two functions. First, they serve as reminders of the name of the drug product made by that company. This is important for companies seeking to establish a brand name for their product. Second, they help a pharmaceutical company sales representative establish a connection and relationship with a physician. Appropriate gifts are of nominal value and help in differentiating one pharmaceutical product from another.
4. What is the AMA's concern?
Physicians must avoid even the perception that their medical judgment can be compromised. By following the AMA's ethical guidelines on gift giving, physicians eliminate that perception and put the focus of interactions between physicians and reps where it needs to be — on how to best improve patient care. Professionalism is an increasingly important topic for physicians, and following ethical guidelines is a cornerstone of professionalism.
5. What do the guidelines say?
In short, the AMA guidelines state physicians should accept only gifts that entail a benefit to patients and that are of modest value. Individual gifts related to the physician's work, such as pens and notepads are also acceptable. And no gift should be accepted if there are strings attached.
6. Why is the AMA getting involved?
While the AMA guidelines were credited with helping to curb many inappropriate practices in the early 1990s, by the late 1990s, it was becoming clear that some physicians and industry representatives were not adhering to them. This conclusion was based on anecdotal evidence, published studies and an increase in media reports on the subject. In 1999, an AMA task force recommended that an educational effort be initiated to raise awareness of the guidelines among physicians. In response, in 2000 the AMA assembled the Working Group for the Communication of Ethical Guidelines on Gifts to Physicians from Industry. The group has met several times since mid-2000 to address the need to raise awareness of ethical guidelines on gift giving.
The AMA continues to believe that the ethics guidelines developed in 1990 provide a sound framework to minimize conflicts of interest and to prevent the integrity and trust in the patient-physician relationship from being compromised by promotional or marketing activities.
7. Why is industry participating in the AMA effort?
Because it is important that not only physicians but also industry representatives understand the ethical standards set by the AMA. The guidelines that the AMA developed were issued more than a decade ago and many industry employees may not be aware of them. This effort will provide an opportunity for industry, as well as the AMA, to educate their constituents about these guidelines.
8. Who serves on the working group?
The group includes more than 30 members, representing physicians, corporations, medical associations, government, medical educators, industry trade groups, and the public. View a full list.
9. What is the group trying to accomplish?
It is launching an educational initiative to raise awareness of the AMA guidelines on this issue and to sustain that awareness over time. The group hopes to create an awareness of the need for high levels of professionalism by physicians and industry representatives regarding the issue of gift giving. At the heart of the effort is a comprehensive educational initiative, intended to remind everyone that the AMA guidelines exist and should be followed.
Another way of looking at this effort is to consider it a form of continuous quality improvement. The AMA guidelines were passed nearly a decade ago and it only makes good sense to raise awareness of them today. Hundreds of thousands of new physicians and tens of thousands of new industry representatives have joined the workforce since the guidelines were passed, and they simply may not be aware.
It is in the best interest of both sides — physicians and industry — to follow the guidelines. By failing to follow them, both physicians and industry reps are cast in a negative light. Thus, industry and physicians are joining together to do what is in best interests of both of their professions.
It is important to note that this initiative uses the AMA guidelines as an appropriate standard, while recognizing that other guidelines do exist (many other medical societies, for example, have guidelines).
The key point is that physicians and industry representatives should be following established, appropriate and ethically sound guidelines regarding gift-giving.
10. What is the AMA doing to raise awareness?
In its early stages, the effort will rely on raising awareness by communicating directly with internal audiences (physicians and industry representatives). The initiative will utilize newsletter and journal articles, "opinion" pieces, direct mailings, presentations at meetings, one-to-one visits with industry and medical leaders, and display advertising. A Web site has been created that will also provide comprehensive information on this topic. In later phases, the effort will offer educational resources that can be used by medical schools and residency programs, and in industry orientation and training programs and continuing education.
11. How will you enforce compliance with the guidelines?
This initiative is aimed at education, not enforcement. The Working Group strongly believes that awareness building is the most important step, and that is the focus of this initiative.
The AMA can't be there every time a physician sits down with an industry representative. But that's not our goal. What we can do is make sure clear ethical guidelines are in place that both parties are aware of and accept as a standard.
12. Why would physicians want to do this? What's the incentive for them to give up something that benefits them?
Physicians don't want to act unethically. They want to be well regarded by their colleagues, peers and patients. We know from published reports and anecdotal evidence that many physicians are simply unaware that the guidelines exist.
13. How about sales reps? Why would they want to go along with these guidelines, which limit their ability to promote their products?
This initiative does not seek to limit promotion of products. It does, however, seek greater adherence to ethical standards. Industry cares about its reputation with physicians and the public. And that means adhering to high ethical standards is good business. Industry is participating in this initiative because it recognizes that following ethical standards is the right thing to do.
14. How are sales representatives currently trained to interact with physicians?
Sales representatives are extensively trained. Included in that training is instruction in how to establish and maintain appropriate relationships with health care professionals. Every pharmaceutical company has internal guidance on how such relationships should evolve, including the issues of ethics. Employees whose actions violate the internal standards are dealt with by their employers. Pharmaceutical companies strive to maintain the highest standards in dealing with health professionals.
15. What extra training for sales representatives will take place as part of this effort?
That will be up to each individual pharmaceutical company.
16. Can the Working Group really speak legitimately for all of industry and organized medicine?
Some associations and some corporations may choose not to be involved with this initiative. That is their prerogative. The Working Group is not trying to speak on BEHALF of all of industry and organized medicine, but rather, to reach out TO all of industry and organized medicine. Our goal is to spread a message that we hope — and believe — they will accept.
17. What about other ethical guidelines that address this topic? Can a physician or industry representative adhere to other guidelines?
Yes, however this initiative is trying to raise awareness of CEJA Ethical Opinion 8.061 as an effective benchmark for all physicians and industry representatives to follow. The ethical statements of many medical societies incorporate the AMA Code of Ethics, and others have developed their own standards, which may also be useful for those seeking ethical guidance.
18. How is the project being funded?
This effort is being funded and staffed by both industry representatives and physician organizations, partially by educational grants, as well as in-kind staff assistance from various organizations. In addition to the AMA, funding has been provided by the American Medical Association Industry Roundtable Steering Committee, Eli Lily & Co., Glaxo Wellcome, Merck & Co., Pfizer, Pharmacia Corporation, AstraZeneca, Bayer Corp., Proctor and Gamble and Wyeth-Ayerst Pharmaceutical.
In-kind assistance has been provided by:
- Accreditation Council on Continuing Medical Education
- AdvaMed
- Alliance for Continuing Medical Education
- American Academy of Family Physicians
- American Academy of Pediatrics
- American College of Obstetrics and Gynecology
- American College of Physicians
- American Society of Internal Medicine
- American College of Surgeons
- American Medical Association
- American Medical Association
- Council on Ethical and Judicial Affairs
- Council on Medical Education
- Department of Media Relations
- Department of Member Relations
- Division of Continuing Physician Professional Development
- Division of Ethical Standards
- Resident Physician Section
- Medical Student Section
- Young Physician Section
- American Osteopathic Association
- American Psychiatric Association
- American Society of Anesthesiology
- Coalition for Health Care Communications
- Council on Medical Specialty Societies
- National Medical Association
- Pharmaceutical and Research Manufacturers of America
- Pharmacia Corporation
- Physicians World
- Society for Academic Continuing Medical Education
- United States Department of Veterans Affairs
The AMA is providing both cash funding and in-kind assistance.
19. How are the funds being utilized?
The early stage of this initiative is intended as a kind of "seeding" effort; that is, encouraging other organizations to spread this message to their own internal audiences. Our goal is to get as much information into the hands of key parties as possible — medical associations, medical schools and residency programs, pharmaceutical companies and trade groups — leveraging their communications channels to reach their audiences. In the later stages, we will reach out with more direct educational resources, available at our Web site. We are encouraging all interested parties to become partners in this project, starting their own educational efforts to supplement ours.
20. What educational resources are you providing?
The resources will include downloadable information from the Internet — primarily case studies, with supplemental information about legal ramifications and requirements and suggestions for using the case studies effectively in a variety of situations. The resources will be made available from the initiative's Web site in 2002.
21. For whom are the educational resources designed for?
They are designed for medical schools, residency programs, continuing education programs, medical specialty society ethics/program committees, county medical society education committees, industry training programs and human resources departments.
22. What happens when this initiative is over?
Some elements of the initiative will be ongoing — the Web site, for example, will be available permanently after the initiative has ended. Because the AMA is acting largely as a facilitator with this initiative, encouraging others to come up with their own educational campaigns, we expect sustained activity by others when the initiative is over. After the second phase of this project — implementation of educational resources — we will evaluate the situation and decide if more awareness-building is necessary.
23. Who will be watching over this to ensure physicians and industry representatives are kept aware of the guidelines into the future?
Again, we're hopeful that our awareness-building activities will take hold with enough organizations that they will be sustaining. But we expect other forces to help. For example, one encouraging trend is that more and more organizations are stressing the importance of professionalism in their codes, principles, standards and other requirements. This trend is most obvious with specialty boards, but it also is happening with groups like the Accreditation Council for Graduate Medical Education, which is currently evaluating its core competency requirements to emphasize professionalism more strongly. Our initiative epitomizes professionalism. As we seek to raise awareness of the CEJA guidelines, we will encourage medical schools and residencies to include material on gift giving practices as part of their professionalism curriculum.
24. How can I help this initiative?
You can help the initiative generally by raising awareness with your key audiences, helping us reach more physicians and industry representatives. If you communicate with your colleagues through a newsletter, journal or Web site, please publish the AMA guidelines, along with information about them. If you are involved in industry, please strive to educate your company and sales force about the initiative and its goals.
While the AMA guidelines are being offered as an appropriate ethical standard, remember that other codes and guidelines may be just as helpful for physicians and industry representatives. If your organization has its own guidelines on this subject, we urge you to ensure that your members are aware of them.
You may also want to consider distribution of the AMA's publication "What You Should Know About Gifts to Physicians from Industry." Copies of this handy brochure may be ordered by calling (312) 464-5101.
25. Where can I go for more information?
Ethical guidelines for gifts to physicians from industry
Content provided by: Gifts to Physicians