Independent panel upholds Lyme disease guidelines

An independent panel of investigators upheld Lyme disease guidelines from the Infectious Diseases Society of America, according to a report published in Clinical Infectious Diseases.

The recommendations contained within the guidelines are “medically and scientifically justified on the basis of all of the available evidence,” the panel members wrote.

The IDSA released the guidelines in 2006. Shortly thereafter, they became the subject of an antitrust investigation by Connecticut Attorney General Richard Blumenthal, who claimed several authors had conflicts of interest. Blumenthal halted his investigation after the IDSA agreed to let an independent panel review the guidelines.

Members of the review panel were selected through an open application process, during which an ombudsman vetted all applicants for conflicts of interest. Once selected, each panel member assumed responsibility for a different section of the guidelines and conducted a thorough review of the literature, received submissions from the public and participated in an all-day public hearing.

Sections of the guidelines reviewed by the panel included:

• Tick bites and prophylaxis of Lyme disease.
• Early Lyme disease.
• Late Lyme disease.
• Post-Lyme disease syndromes.
• Human granulocytic anaplasmosis.
• Human babesiosis.

An open discussion followed the individual reviews. During the discussion, panel members assessed the validity and appropriateness of the section in their charge.

The eight-person panel unanimously approved 68 of 69 recommendations made in the guidelines; the one non-unanimous decision was approved by a 7-1 vote. Minor changes to the language or content were suggested, but these suggestions did not affect the vote.

At the request of Blumenthal, the panel gave special consideration to post-Lyme disease syndromes, which have been at the center of controversy and publicity. After further discussion, the panel agreed with the IDSA that extended antibiotic treatments are not useful in patients with chronic subjective symptoms, and that the existence of chronic persisting Lyme disease had not been confirmed scientifically.

Blumenthal also asked the panel to review a specific section in the executive summary indicating that clinical findings alone could diagnose erythema migrans but were not sufficient for diagnosing extracutaneous manifestations, human granulocytic anaplasmosis or babesiosis. The panel split evenly on whether to revise the statement and, ultimately, made no changes.

However, the panel qualified its findings.

“The presence of certain classic complications of Lyme disease, such as aseptic meningitis, atrioventricular nodal block, inflammatory arthritis, and cranial or peripheral neuropathies, in a patient with epidemiologic risk of Lyme disease and in whom alternative diagnoses have been excluded or are unlikely, may be sufficiently convincing as to constitute an exception to the statement in the executive summary,” they wrote.

The panel suggested two changes when the guidelines are next updated: an expanded section on diagnostic testing, and a new section on the southern tick-associated rash illness that is currently presenting in the South and parts of the East Coast.

The report of the independent panel is a victory for patients and for science in that it confirmed that the original guidelines were based on the best scientific evidence available. The independent panel was chosen by a medical ethicist ombudsman who assured that none of the members of the panel had any potential conflicts of interest. Hopefully, this decision will allow IDSA and the scientists involved to use their valuable time and resources to focus on moving forward developing research and policies to help patients.

– Eugene Shapiro, MD
Infectious Diseases In Children Editorial Board member

Lantos PM. Clin Infect Dis. 2010;51:1-5.