IDSA Lyme Disease Guidelines Process Flawed

In 2010, Lorraine Johnson and Dr. Stricker published this article detailing the flaws in the IDSA Lyme disease guidelines development process. The article underwent a particularly brutal and suppressive peer review process at the hands of IDSA peer reviewers before it landed at the Journal of Philosophy, Ethics, Medicine and Humanities, where it became the fifth most widely viewed article for the journal for all time with over 27,000 views.

The Infectious Diseases Society of America Lyme guidelines: a cautionary tale about the development of clinical practice guidelines
By Lorraine Johnson, JD, MBA and Raphael B Stricker, MD

Abstract

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.

Introduction

‘Without health, there is no happiness’. Thomas Jefferson

‘The strong do what they can; the weak endure what they must’. Thucydides

With 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. 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.

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. 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.