AMA ETHICS COUNCIL OPINION AGAINST INDEMNITY OFFERS FROM DRUG COMPANIES REQUIRES FURTHER STUDY, AMA DELEGATES DIRECT; ACCME REVISED CME RULES ENDORSED

American Medical Association members have asked their Council on Ethics to take a longer look at the council's recent document suggesting that physicians should not accept indemnity offers from drug and medical device manufacturers. AMA's Council on Ethical and Judicial Affairs issued an opinion that offers from medical product manufacturers to indemnify physicians against lawsuits arising from use of the manufacturer's product are a form of gift or incentive to prescribe and thus raise "clear ethical problems" ("The Pink Sheet" June 22, T&G-6). During a June 23 session of AMA's House of Delegates in Chicago, the physician delegates asked for further analysis of the issue, to include implications for physicians participating in clinical trials. Some AMA delegates also suggested that indemnity offers may not be inappropriate in that the physician does not actually receive any item of monetary value from a manufacturer unless the physician is sued, and the indemnity offers cover only the product itself and not the physician's overall treatment judgment. Others pointed out that hospitals frequently indemnify physicians for work on peer review committees and other hospital panels. The Ethics Council had concluded that even if no monetary payment is made, an indemnity offer has an economic value because it reduces a physician's financial exposure for use of a product. Companies that recently have offered to pay physicians' legal costs for any suits related to their products include Eli Lilly for Prozac and Upjohn for Halcion. The physician delegates went through a complicated parliamentary procedure to ask the council to look again at the opinion. Reports and recommendations that are voted on by the delegates become official AMA policy, but council "opinions," which comment on current issues in light of AMA's existing ethics code, are merely filed and not designated as official policy. On the other hand, the delegates pointed out that they consider themselves bound by the Ethics Council's opinions and thus wanted to take a vote to express their views. The issue of indemnity was one of three topics debated June 23 where delegates appeared to be frustrated that AMA may be going too far in spelling out specifically how members should adhere to general ethical principles of the association. The two other ethics issues raised at the meeting were physician referrals of patients to health facilities in which the physician has an ownership interest and ways for physicians to meet an ethical obligation to care for the poor. * In a June 24 memo to AMA members, the ethics council alerted members to several items on its study agenda for the next six months, including indemnity offers from manufacturers, reporting adverse drug reactions and lobbying patients on political issues. The council has not decided whether these will be addressed in "opinions" or "reports." Regarding industry-funded CME, the delegates approved a resolution stating that AMA will "endorse the Accreditation Council for Continuing Medical Education's 'Revised Standards for Commercial Support of Continuing Medical Education'" ("The Pink Sheet" May 4, p. 5). In addition to giving the revised standards the "greatest publicity possible," AMA will work with its state societies to aid compliance with the standards, the resolution adds. It notes that compliance with the guidelines may be "a major factor" in continuing commercial support for CME and this support is "crucial" for many CME providers, including medical schools and small community hospitals. Two very similar versions of the resolution were proposed by Alabama delegates and AMA's Young Physicians Section. FDA is working on a second CME "concept paper" as part of the development of its own regulation to delineate differences between CME and industry promotional activities ("The Pink Sheet" June 15, p. 10).