DRUG COMPANY ETHICAL STANDARDS FOR INDUSTRY/PHYSICIAN RELATIONSHIPS

DRUG COMPANY ETHICAL STANDARDS FOR INDUSTRY/PHYSICIAN RELATIONSHIPS should be developed more fully by the Pharmaceutical Manufacturers Association, the American Academy of Family Physicians suggested Sept. 25. AAFP's Congress of Delegates adopted a "White Paper on Proprietary Practices" that endorses ethical guidelines on industry/physician relationships that have been developed under the aegis of the American Medical Association. AAFP held its 43rd Annual Assembly in Washington, D.C. Sept. 24-29. The white paper states that AAFP's "Board of Directors will directly communicate to the Pharmaceutical Manufacturers Association (1) an acknowledgement of acceptance by the PMA of the AMA guidelines, and (2) a request that PMA develop guidelines beyond its existing "Code of Ethics" that addresses the responsibility of industry in the areas of marketing, promotion and education." The board will express its "concern that the onus of responsibility regarding ethical relationships with industry appears to fall upon the physician without a parallel response by industry," the white paper states. "The board will ask for such a parallel responsibility at all levels of the corporate structure (including product managers and detail representatives)." Nonetheless, the paper advises AAFP's 70,000 members that the "decision regarding the appropriateness of an activity" often may fall to the individual physician, "who may be called upon to investigate an activity's agenda, participants, intent and expected outcome." Based on the guidelines, AAFP has determined that it must change some of its own practices regarding industry funding of academy-sponsored meetings. In the future, for example, funds from proprietary groups for continuing medical education programs "must be in the form of an educational grant made payable to AAFP as the accredited sponsor for the support of programming." The white paper notes that the academy believes the "funding arrangements of one or more continuing education programs, whereby the funder directs support monies to the third party hired by the academy for program development, are in violation of the spirit and intent" of the guidelines. While most AAFP educational programs comply with the guidelines' intent, a "few exceptions" also include programs, "notably the three-hour continuing education courses and the academy 'dialogue' series, that have been funded and produced by pharmaceutical companies or their designated third-party consultants, with oversight and input from the Committee on Scientific Programs." To address this issue, the white paper reaffirms AAFP's need to maintain "responsibility for and control over" program content, including selection of agendas and speakers. To help meet this requirement, the academy will investigate the "feasibility of creating a new entity within or responsible to the AAFP for planning and producing continuing medical education programs." Other AAFP meeting practices that are being discontinued include acceptance of funds covering the costs of members' families attending meetings, publicity photos at meetings and raffle prizes. These do not comply with the ethical guidelines requirement that gifts provided at meetings must be of modest value and of some direct benefit to patients. "By and large," the white paper concludes, "the support of professional medical activities by proprietary entities has benefited both physician and patient. The intense examination of these activities has been brought about primarily by the transgression of a few, and any efforts to refine existing relationships should not detract from the goodwill and contributions of many." The document also states that the guidelines are inappropriately limited to the pharmaceutical and medical device industries and instead should extend to all relationships with "proprietary health-related entities" that might create a conflict of interest. For example, "it would be as inappropriate to receive a referral fee from a home health care company as to receive travel advantages for frequent prescribing from a pharmaceutical company," the paper says. While many physicians "object" to suggestions that their clinical decisions might be affected by promotional activities, the paper remarks, bias may be "subtle" and may intrude despite the best efforts of physicians and meeting sponsors. However, the AAFP specifically opposes "federal or state government efforts to enforce the guidelines. The issue of enforcement is the responsibility of physicians and their organizations." Possible sanctions include censure or expulsion from professional organizations.