Dr. Stricker and I have published a new peer-reviewed article on the flawed IDSA Lyme guidelines development process, the antitrust investigation, and the lack of impartiality in the mandated review process run by the IDSA. The article is now the number 1 accessed article of the publisher with over 1600 hits in the week since it was published. (Johnson L, Stricker R. “The Infectious Diseases Society of America Lyme guidelines: A cautionary tale about development of clinical practice guidelines,” Philosophy, Ethics, and Humanities in Medicine;5:9 2010.) The article is open access. The two lead in quotes set the stage. The first is by one of the nation’s founding fathers, Thomas Jefferson: ‘Without health, there is no happiness’. The second quote is by Thucydides and speaks to power and its abuse. ‘The strong do what they can; the weak endure what they must’. An excerpt of the article follows the jump:

..The full article may be accessed here.    Excerpt:

“Sniderman and Furberg argue that the developers of treatment guidelines can become ‘promoters and defenders’ of the guidelines produced under their auspices [4]. When an organization’s guidelines are legally challenged — as they were here — the validation of the guidelines may become an overarching focus, and to do so quickly and quietly to minimize damage in the press may become a primary goal. Validation of the IDSA Lyme guidelines would permit IDSA to continue to use them to limit competing views of the disease, maintain IDSA’s sphere of influence, continue its domination in the marketplace, and reduce potential litigation risk based on the guidelines. In short, the Lyme guidelines review process constituted a classic conflict of interest: IDSA’s organizational interests trumped its interest in maintaining the integrity of the review process necessary to provide guidelines that hold patient interests paramount. The settlement outlined a process that was primarily run by IDSA, which controlled many of the procedural issues. Given what was at stake, would IDSA be able to set aside its self-interest and decide the issues impartially?”

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.

You can follow additional comments on Lyme policy at www.lymepolicywonk.org.  You can contact Lorraine Johnson, JD, MBA at lbjohnson@lymedisease.org.