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A special review panel has unanimously agreed that no changes need be made to the 2006 Lyme disease treatment guidelines developed by the Infectious Diseases Society of America (IDSA).
The guidelines, voluntarily used by physicians to help them decide what treatments are best and safest for patients, were the subject of an antitrust investigation begun in 2006 by Connecticut Attorney General Richard Blumenthal. Blumenthal examined whether the guidelines’ authors had conflicts of interest and failed to consider divergent medical opinions. IDSA maintains those assertions were unfounded and, as part of an agreement to end the Attorney General’s investigation, voluntarily agreed to a one-time special review of the guidelines by an independent scientific review panel whose members were certified to be free from any conflicts of interest by an independent ombudsman.
Lyme disease is caused by an infection with a type of bacterium called Borrelia burgdorferi, which typically is transmitted by the deer tick. Lyme disease often causes a red, circular rash and muscle and joint aches. A short-course of oral antibiotics remains the standard treatment for patients with Lyme disease, the most common tick-borne illness, which first was discovered in Lyme, Conn.
At issue is the existence of a “chronic” form of Lyme disease and its treatment with long-term antibiotics for months or years. This controversial and costly treatment, which is typically delivered intravenously through a catheter, is advocated by self-described “Lyme literate” physicians.
“IDSA’s primary concern is for the health and safety of patients,” said IDSA president Richard Whitley, MD. “Our goal is to ensure that patients are given treatment that is safe, effective and supported by scientific evidence. Allegations that the 2006 guidelines panelists stood to gain from the recommendations are unfounded. In fact, one could argue the opposite was true, because the panelists recommended short courses of generic drugs.”
To ensure a fair and unbiased review of the 2006 guidelines, IDSA and the Attorney General jointly selected an ombudsman, Howard Brody, MD, PhD, an author and respected medical ethicist at the University of Texas Medical Branch. Brody screened all potential review panel members for conflicts of interest using criteria jointly approved by the Attorney General and the IDSA. The review panel was comprised of nine scientists and physicians from relevant disciplines who had not served on any previous Lyme disease guidelines panel.
The review panel’s work took more than a year to complete, with the group convening 16 times, including at an all-day public hearing in Washington, D.C. More than 150 individuals or organizations submitted evidence and other information including letters, newspaper articles, patient medical records and other materials on Lyme disease and its treatment. Learn more about Lyme disease and the review process.
“This was truly an extraordinary review process,” said Carol J. Baker, MD, who chaired the review panel and is a pediatric infectious diseases specialist at Baylor College of Medicine in Houston. “The final report includes more than 1000 citations, and after thoughtfully and carefully reviewing myriad materials, the panelists feel confident that advice to physicians treating Lyme disease should remain the same as set forth in the 2006 Lyme disease guidelines.”
The review panel concurred that all of the recommendations from the 2006 guidelines are medically and scientifically justified in light of the evidence and information provided, including the recommendations that are most contentious: that there is no convincing evidence for the existence of chronic Lyme infection; and that long-term antibiotic treatment of “chronic Lyme disease” is unproven and unwarranted. Inappropriate use of antibiotics (especially given intravenously) has been shown to lead to deadly blood infections, serious drug reactions and C. difficile diarrhea, as well as the creation of antibiotic-resistant bacteria or “superbugs.”
As noted in the review panel report, “In the case of Lyme disease, there has yet to be a single high quality clinical study that demonstrates comparable benefit to prolonging antibiotic therapy beyond one month.” The report also noted that “the inherent risks of long-term antibiotic therapy were not justified by clinical benefit.”
At the request of the Attorney General, the panel also reviewed a statement in the guidelines’ executive summary concerning diagnostic testing. The panel was evenly split on whether the statement would benefit from modification or clarification. In its final report, the panel offered this guidance to clinicians: “Symptoms that are commonly attributed to chronic or persistent Lyme, such as arthralgias, fatigue and cognitive dysfunction, are seen in many other clinical conditions and are, in fact, common in the general population.... It would thus be clinically imprudent to make the diagnosis of Lyme disease using these nonspecific findings alone.” On the other hand, the panel said, “in clinical practice, the presence of certain classic complications of Lyme disease such as aseptic meningitis, AV 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.”
Whitley notes that, as per the review panel’s recommendation and IDSA's practice, IDSA will review the Lyme disease guidelines on a regular basis to determine the need for updating based on any newly available evidence that would warrant a change to the current recommendations. Guidelines involve synthesizing the highest-quality research available to guide physicians seeking to provide the best and safest care for their patients. In addition to Lyme disease, the Society authors treatment guidelines for more than 50 infectious diseases and conditions, including HIV/AIDS, influenza, pneumonia and C. difficile.
“This special review validates the recommendations, which are again proven to be based on the best science available,” said Whitley. “Our No. 1 concern is the patients we treat, and we’re glad patients and their physicians now have additional reassurance that the guidelines are medically sound.”