The American College of Obstetricians and Gynecologists (ACOG) recently updated its policy on professional relationships with industry by releasing a Committee Opinion that supersedes their original 1985 policy, which had been updated periodically. The policy seeks to contribute toward “maintaining patient trust in the specialty and avoiding conflicts of interest by College members.”
Unfortunately, ACOG’s policy seems to place more emphasis on criticizing, prohibiting, discouraging and severely restricting relationships with industry in various forms, which is evident by the references and studies it uses to support the revisions to its policy.
Background
ACOG recognized that industrial development of pharmaceutical agents and medical devices is important for continuing improvement in health care and that developers and manufacturers of such products assist physicians in the pursuit of their educational goals and objectives through financial support of various medical, research, and educational programs. Nevertheless, they maintain that the goals of industry “may conflict with physicians’ duties to their patients,” despite acknowledging that “in many cases, industry’s goals and physicians’ duties converge.”
ACOG’s concerns stem from the past abuses of companies and physicians who accepted gifts from industry, such as office supplies, meals, trips, gift certificates, cash, and honoraria. But as we have written numerous times over the years, such practices are practically non-existent, illegal in some states, banned by most companies, and prohibited by industry codes.
Nevertheless, ACOG defined “gifts” in its new policy as “items and services that are intended to influence the relationship between a physician and a pharmaceutical or medical device company or that, regardless of the giver’s intent, may be perceived by the public as influencing the relationship.” Unfortunately, ACOG chose to cite biased studies that did not measure the impact of gifts on patient care (Wazana) to support its position that physician-industry relationships should be suspect. Moreover, while the Ethics Committee chose to cite studies about the potential negative influence of such relationships, they did not include any reference to the various surveys of physicians that have shown that physicians in numerous specialties value physician-industry collaboration.
Moreover, to justify their position about the potential negative impact of physician-industry relationships, ACOG appeals to the moral and fiduciary obligations of physicians. They assert that “interactions with industry carry some expectations of reciprocity” and physicians “are unable to remain objective.”
In addition, they recognize that while “disclosure of conflict of interest is imperative to preserve transparency and trust in the profession, disclosure alone may not be sufficient to nullify the effect of the conflict (citing the Institute of Medicine). ACOG noted that “the duration of the conflict of interest, amount of money involved, and role of the physician in relation to the conflict of interest are all salient points for consideration,” as well. Depending on the nature of the activity, ACOG noted that “peer review can be effective in mitigating bias for a presentation; recusal can be considered in the case of a consultative activity, such as a formulary committee; or referral for a second opinion can be offered in the case of a clinical patient recommendation.”
Before making its own recommendations, ACOG gave a brief summary of various recommandations from organizations, such as the American Medical Association, (AMA) Council on Ethical and Judicial Affairs (CEJA), the “PharmFree Campaign” from AMSA, the Council of Medical Specialty Societies (CMSS), the Accreditation Council for Continuing Medical Education (ACCME); PhRMA and AdvaMed Codes; OIG Compliance Program Guidance for Pharmaceutical Companies; and the National Institutes of Health (NIH) regulations regarding research. Unfortunately, ACOG’s emphasis on citing these sources is to show its support for elimination of physician-industry relationships or to limit them severely.
Recommendations
ACOG divided industry–physician interactions into major types, and discussed the ethical implications specific to each type of interaction. In providing recommendations, the Committee on Ethics recognized both the effort its Fellows and other members have made to meet past recommendations and the challenges in meeting the ideal behaviors outlined.
Product Promotion to Individual Physicians by Advertising, Personal Communication, and Provision of Samples
The Committee on Ethics made the following recommendations based on the belief that acceptance of even small gifts may influence or appear to influence prescribing practices and, thereby, have an effect on patient care,:
- To minimize both true and perceived conflicts of interest, physicians have an ethical obligation to set guidelines for themselves and their office staff for interaction with representatives.
- Physicians have an obligation to seek the most accurate, up-to-date, evidence-based, and balanced sources of information about new products that they contemplate using. They should not base decisions solely or primarily on information provided by the products’ marketers.
- Physicians involved in institutional decision making for formularies should declare financial ties with industry and disclose any conflict of interest. Institutions should have a management plan for any declared conflicts, including possible recusal.
- Although the provision of pharmaceutical samples offers potential benefits to patients, samples may inappropriately influence prescribing behavior. Phys-icians may choose to provide samples or vouchers; however, they should be aware that providing samples may promote patients’ ongoing use of a particular medication, when other potential alternatives exist. When vouchers or samples are dispensed, consideration should be given to providing them preferentially to those patients with a true need and dispensing a supply sufficient for a full course of therapy. Dispensing should be done from a central distribution source that can track to whom and where samples were given in the event of recalls or other problems with the medication. Physicians who choose to dispense samples should know the applicable state and federal regulations regarding this practice.
- Physicians should understand that gifts tied to promotional information, even small gifts and meals, are designed to influence their behavior. The acceptance of any gift, even of nominal value, tied to promotional information is strongly discouraged. However, acceptance of cash donations, trips, and services directly from industry by individual physicians raises clear conflicts and is not ethical.
- When an obstetrician–gynecologist receives anything of substantial value, including royalties, from companies in the health care industry, such as a manufacturer of pharmaceutical agents and medical devices, this fact should be disclosed to patients and colleagues when material.
- Physicians should not engage in agreements in which companies make donations to a third party (e.g., a hospital or charitable organization) that is contingent on the physicians’ use or advocacy of a product.
Support of Educational Activities for Individual Physicians
ACOG made the following recommendations for educational support for individual physicians:
- The gift of special funds to permit medical students, residents, and fellows to attend carefully selected educational conferences may be permissible as long as the selection of the students, residents, or fellows is made by the academic or training institution or by the accredited CME provider with the full concurrence of the academic or training institution. These funds should be deposited at a central office within the training institution that can dispense these funds directly to the designated trainee (ie, the company does not directly disperse funds to the trainee).
- Payments to defray the costs of attending a CME or professional conference should not be accepted directly from the company by physicians attending the conference. Subsidies from industry should not be accepted directly to pay for the costs of travel, lodging, or other personal expenses. Subsidies should not be accepted to compensate attendees for their time.
- Commercially supported social events and industry symposia, regardless of whether they are affiliated with a program offering CME credits, are essentially gifts and are designed to influence physician behavior.
Industry-Sponsored Device Training
When new medical devices are approved or cleared by the U.S. Food and Drug Administration (FDA), access to training on those devices may be tightly regulated by the FDA and may require training by the manufacturer. The company may require physicians to travel to non-CME seminars designed to familiarize the physician with the new equipment. This presents an ethical difficulty for the physician. This problem has been considered by other professional organizations, such as the Society of Thoracic Surgeons and the American Association for Thoracic Surgery. They suggest that their members may attend such industry-sponsored events “only when the major purpose of the event is education and training in the proper use of the company’s products; the only financial considerations should be reimbursement for travel, meals, and lodging. Members should not accept reimbursement for attending such an education event if the event’s location constitutes an inducement that is independent of the event’s educational value.” The Committee on Ethics makes the following recommendations regarding industry-sponsored device training:
- Training in proper use of devices encountered in the practice of obstetrics and gynecology is ideally provided through professional societies with CME accreditation.
- When training is not available from an accredited CME provider, or industry training is mandated by the FDA, and industry offers appropriate education, the obstetrician–gynecologist may participate if the training is focused on the safe, medically relevant, and FDA-cleared or FDA-approved indications for use of the equipment or device in the shortest possible time.
Industry Sponsorship of Research
When companies conduct clinical research to obtain approval for the marketing of new products, collaboration with physicians and clinical institutions is essential. The Committee on Ethics recommended the following guidelines for engaging in industry-sponsored research:
- Research trials should be conducted in accordance with the federal guidelines for the protection of human participants. Approval by the institutional review board of a medical school or hospital provides adequate ethical and scientific review. If the project is to be conducted in a private medical office, investigators must ascertain the nature of the ethical and scientific review process by the sponsoring corporation. Submission of the project to the researcher’s institution usually is required and helpful. If there is any question about the adequacy or efficacy of this review, investigators should seek independent consultation for research oversight.
- Reimbursement to investigators and their institutions for involvement in research, including recruitment of participants, should not exceed reasonable costs. Payments made specifically to physicians for recruitment of their patients should be disclosed to potential study participants before trial enrollment.
- Investigators may accept reasonable compensation (at fair market value) for consultation after participation in industry-sponsored research.
- Once a clinical investigator becomes involved in a research project for a company or knows that he or she might become involved, the investigator, as an individual, cannot ethically buy or sell the company’s stock until the results of the research are published or otherwise disseminated to the public and the involvement ends.
ACOG also recommend the following guidelines to govern control over information gained from research:
- All obligations of investigators and sponsors should be contractually defined.
- Scientific freedom of independent investigators (those not employed by the funding organization) should be preserved.
- Principal investigators should be involved in decisions regarding the publication of data from their trials. Short delays in the dissemination of data generated by industry-sponsored research are acceptable to protect a patent or related proprietary interest. Prolonged delays, or suppression of information harmful to the sponsor’s interests, are unethical.
- Investigators should control the use of their names in promotions.
- Project funding should not be contingent on results.
- Investigators should disclose their relationships with industry funders in publications or lectures based on the research.
Speakers’ Bureaus
ACOG strongly discouraged participating in an industry-sponsored speakers’ bureau. Nevertheless, ACOG recommended that physicians who choose to participate in industry-sponsored speaking should adhere to the following specific ethical guidelines to reduce the risk of undue influence:
- Speakers must disclose the extent and nature of their relationship with the sponsoring entity.
- Speakers must ensure that the information in their presentation is accurate, balanced, evidence based, and free of undue commercial influence. The speaker should have final control of any slides used in the presentation and should not sign a contract that gives the commercial entity control of the slide content.
- Speakers must accept only reasonable honoraria commensurate with the value of their time and reimbursement for travel, lodging, and expenses.
Physicians as Consultants to Industry
Consulting with industry on the development of new medical devices or pharmaceutical agents can play an important role in the progress of scientific discovery. It also is appropriate for consultants who provide genuine services to receive reasonable reimbursement for travel, lodging, and meal expenses, as well as value of their time. 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. It must be recognized, however, that industry may use consulting arrangements in order to influence the consultant. Physicians who consult with industry on the development of new medical devices or pharmaceutical agents must disclose this information to their patients, colleagues, and medical institutions when material.
Ghostwriting
According to the ACOG paper, the practice of ghostwriting, or unacknowledged medical writing sponsored by the pharmaceutical or other industry, is unacceptable because it is inherently deceptive. Authors should write and assume responsibility for the content of all publications for which they receive authorship credit. Ghostwriting, in which a writer produces content attributed to another, should be distinguished from acknowledged authorship and peer editing, which may serve important communication functions.
Conclusion
As in all these recent proclaimations on this issue emaphasize the risk of the relationship in working with industry vs. the benefit those relationships serve to the greater good of patients in the form of new drugs and devices which have enabled OB-GYN’s to enhance and save lives.
Obstetrician–gynecologists’ relationships with industry should be structured in a manner that will enhance, rather than detract from, their obligations to their patients. The ideal behaviors set forth in this Committee Opinion have the goal to “contribute toward maintaining patient trust in the specialty and avoiding conflicts of interest by College members” unfortuntately much of this means just more regulations-codes.