Lyme Disease Practice and Research

Dr. Cameron's Presentations- Page 2

Rapid response to: Alison Tonks LymeWars
BMJ 2007; 335: 910-912

British Medical Journal

The letter from Donald Poretz, the president of the Infectious Diseases Society of America (IDSA) (1), could be viewed as another example of the “Lyme Wars” described by Alison Tonks (1). Dr. Poretz cites the status of IDSA rather than the evidence as support for the IDSA guidelines recommendations. (2) The IDSA guidelines neither referenced the published International Lyme and Associated Diseases Society (ILADS) guidelines (3) nor did the IDSA include ILADS members in their guidelines committee.

The IDSA guideline committee fail to address the concerns of ILADS that the IDSA places too much reliance on a single study that enrolled Lyme disease patients who had already been ill an average of 4.7 years, and had already had an average of three courses of previous treatment without success. (3) The results of this study are not generalizable to the patient population that clinicians see in their offices (4).

The IDSA guideline committee also fail to resolve the ILADS guideline committee’s concern with the poor sensitivity of two-tier approach to B burgdorferi antibody testing, recommended by the US Public Health Service and European experts some 12 years ago. Dr. O’Connell in a follow-up letter to the BMJ cited Wilske and associates as evidence that the 2-tier diagnostic test is sensitive (5). But in actuality, Wilske and colleagues had concluded that neither the recombinant immunoblot nor the conventional whole-cell lysate immunoblot used in the 2-tier diagnostic tests was more than 52.7% and 63.8% sensitive respectively (5).

Most controversies occur when there is little evidence. The total number of subjects enrolled in published RCTs to date amounted to only 221 subjects. This same size –is far too small to draw broad conclusions suppressing the only treatment option known to be effective for Lyme disease. Moreover, the results of the studies are limiting and conflicting. When evidence is uncertain and controversy exists, it is critical for the medical community to be able to evaluate conflicting positions, the basis for the medical evidence cited, study criteria, professional agendas and conflicts of interests that may exist. Only by airing these different points of view will the medical and scientific community reach a better understanding of controversial topics such as chronic Lyme disease. Meanwhile, physicians must be able to exercise their clinical judgment and patients should be provided with treatment options.

It is time the medical community considers Lyme Disease as another example of a “clinical equipoise”-- absence of consensus within the clinical community—rather than resign themselves to “Lyme Wars”.

Sincerely,

Daniel Cameron, MD, MPH
President, ILADS
175 Main Street
Mt. Kisco, New York 10549
Tel: 914-666-4665

References

  1.  Tonks A. Lyme wars. Bmj. 2007;335(7626):910-2.

  2.  Wormser GP, Dattwyler RJ, Shapiro ED, et al.
            The clinical assessment, treatment, and prevention of lyme disease, human granulocytic
           anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases
            Society of America. Clin Infect Dis. 2006;43(9):1089- 134.

  3.  Cameron D, Gaito A, Harris N, et al. Evidence-based guidelines for the management
            of Lyme disease. Expert Rev Anti Infect Ther. 2004;2(1 Suppl):S1-13.

  4.  Cameron DJ. Generalizability in two clinical trials of Lyme disease.
           Epidemiol Perspect Innov. 2006;3:470-2.

  5.  Wilske B, Fingerle V, Schulte-Spechtel U. Microbiological and serological
           diagnosis of Lyme borreliosis. FEMS Immunol Med Microbiol. 2007;49(1):13-21.

Competing interests: None declared

For a link to the British Medical Journal response http://www.bmj.com/cgi/eletters/335/7626/910#181433