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... As we have argued elsewhere, the exclusion of competing evidence in treatment guidelines is clinically and ethically unacceptable [74,75]. Failure to disclose treatment options violates the principles of patient autonomy and informed consent, which require that treatment options should be disclosed to patients and that treatment decisions should be made with the patient's informed consent . ...
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.
Lyme disease is a controversial illness, and the existence of chronic Lyme disease induced by persistent infection with the Lyme spirochete, Borrelia burgdorferi, is the subject of continued debate. A recent publication defined the 'Axis of Evil' in this controversy as physicians who treat patients with needlessly prolonged courses of antibiotics, 'specialty laboratories' that perform 'inaccurate' Lyme testing and the internet, which promotes 'Lyme hysteria'. We examine the 'Axis of Evil' components in the context of diagnostic and therapeutic challenges for Lyme disease patients and their physicians, and we present an evidence-based refutation to this misguided view. Despite its virulent nature, the 'Axis of Evil' perspective is a useful starting point to resolve the controversy over Lyme disease.
Lyme disease is the most common tick-borne disease in the world today. Despite extensive research into the complex nature of Borrelia burgdorferi, the spirochetal agent of Lyme disease, controversy continues over the diagnosis and treatment of this protean illness. This report will focus on two aspects of the treatment of Lyme disease. First, the medical basis for diagnostic and therapeutic uncertainty in Lyme disease, including variability in clinical presentation, shortcomings in laboratory testing procedures, and design defects in therapeutic trials. Second, the standard of care and legal issues that have resulted from the clinical uncertainty of Lyme disease diagnosis and treatment. Specifically, the divergent therapeutic standards for Lyme disease are addressed, and the difficult process of creating treatment guidelines for this complex infection is explored. Consideration by healthcare providers of the medicolegal issues outlined in this review will support a more rational approach to the diagnosis and treatment of Lyme disease and related tick-borne illnesses.