Johnson Lorraine, Stricker Raphael B
California Lyme Disease Association, Ukiah, CA, USA.
Philos Ethics Humanit Med. 2010 Jun 9;5:9. doi: 10.1186/1747-5341-5-9.
Flawed clinical practice guidelines may compromise patient care. Commercial conflicts of interest on panels that write treatment guidelines are particularly problematic, because panelists may have conflicting agendas that influence guideline recommendations. Historically, there has been no legal remedy for conflicts of interest on guidelines panels. However, in May 2008, the Attorney General of Connecticut concluded a ground-breaking antitrust investigation into the development of Lyme disease treatment guidelines by one of the largest medical societies in the United States, the Infectious Diseases Society of America (IDSA). Although the investigation found significant flaws in the IDSA guidelines development process, the subsequent review of the guidelines mandated by the settlement was compromised by a lack of impartiality at various stages of the IDSA review process. This article will examine the interplay between the recent calls for guidelines reform, the ethical canons of medicine, and due process considerations under antitrust laws as they apply to the formulation of the IDSA Lyme disease treatment guidelines. The article will also discuss pitfalls in the implementation of the IDSA antitrust settlement that should be avoided in the future.
存在缺陷的临床实践指南可能会损害患者护理。编写治疗指南的专家小组中存在的商业利益冲突尤其成问题，因为小组成员可能有相互冲突的议程，这会影响指南建议。从历史上看，对于指南专家小组中的利益冲突没有法律补救措施。然而，2008年5月，康涅狄格州总检察长对美国最大的医学协会之一——美国传染病学会（IDSA）制定莱姆病治疗指南展开了具有开创性的反垄断调查。尽管调查发现IDSA指南制定过程存在重大缺陷，但和解协议要求对指南进行的后续审查在IDSA审查过程的各个阶段都因缺乏公正性而受到影响。本文将探讨近期对指南改革的呼吁、医学伦理准则以及反垄断法下的正当程序考量在适用于IDSA莱姆病治疗指南制定时的相互作用。本文还将讨论IDSA反垄断和解协议实施过程中应在未来避免的陷阱。
