The Infectious Diseases Society of America Lyme guidelines: a cautionary tale about the development of clinical practice guidelines

'Without health, there is no happiness'. Thomas Jefferson'The strong do what they can; the weak endure what they must'. ThucydidesWith the trend toward centralized medical decision making and evidence-based medicine, clinical practice guidelines are becoming a key factor in the practice of medicine and are increasingly relied upon by physicians seeking treatment guidance. However, when guidelines panels fail to conscientiously safeguard the integrity of the guideline development process, the quality of guidelines may be eroded and fall short of the primary goal of guidelines--namely improving patient outcomes [1]. The Connecticut Attorney General's antitrust investigation into the Lyme disease treatment guidelines development process of the Infectious Diseases Society of America (IDSA) underscores the importance of these problems and the need for guidelines reform [2].Guidelines have become a way to drive the medical standard of care that governs physician conduct. When inflexible guidelines are adhered to by insurers, government agencies, medical societies and hospitals, guidelines can essentially create a de facto regulatory scheme fraught with economic, legal, and patient care consequences. Accordingly, guidelines, particularly those formulated by medical societies that are considered dominant under antitrust laws, hold enormous influence over the practice of medicine, creating a situation that is ripe for abuse [3]. For example, third parties such as the insurance industry and pharmaceutical companies whose commercial interests may be affected by guidelines may seek to influence the guidelines development process through the use of 'key opinion leaders' (typically academic researchers) who serve on guidelines panels. The enormous influence of clinical practice guidelines also creates the potential for the guidelines of a dominant medical society to be used competitively against less influential medical societies.The primary goal of clinical practice guidelines i