Legal Controversy Over Lyme Disease
Clinical Guidelines From Two Expert Panels are in Conflict
Jul 19, 2009
Few infectious diseases have generated as much controversy as Lyme disease. Almost from the time its causal agent was identified, medical professionals and patients alike have argued about Lyme’s diagnosis, treatment, chronicity, and long-term effects.
Oddly enough, physicians who have treated Lyme patients in ways that don’t adhere to guidelines developed by the Infectious Diseases Society of America (IDSA) have been sanctioned by medical review boards, and patients who have received such “non-standard” therapy have often been denied payment by their insurance carriers.
At the center of this debate are two sets of evidence-based Lyme disease practice guidelines—one published by IDSA, and the other by the International Lyme and Associated Diseases Society (ILADS)—that frequently conflict. (Wormser G, 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;43:1089-1134, and Cameron D, et al. Evidence-based guidelines for the management of Lyme disease. Expert Rev Anti Infect Ther 2004;2(1 suppl):S1-S13)
In a precedent-setting action, in May 2008, Connecticut Attorney General Richard Blumenthal and the Infectious Diseases Society of America (IDSA) entered into a legal agreement that mandates a reconsideration of IDSA guidelines. This consensus was reached after Blumenthal launched an investigation into the manner in which IDSA developed and disseminated its guidelines. (Blumenthal R. Attorney general's investigation reveals flawed Lyme disease guideline process, IDSA agrees to reassess guidelines, install independent arbiter. State of Connecticut: Attorney General's Office; May 1, 2008)
Where IDSA and ILADS Agree
- Lyme disease is caused by a spirochete, Borrelia burgdorferi, that is transmitted by infected ticks.
- Lyme disease first presents as a syndrome of flu-like signs and symptoms.
- Early Lyme disease is sometimes accompanied by a characteristic rash (erythema migrans).
- Borrelia can cause neurologic, heart, and joint problems.
Where IDSA and ILADS Disagree
- IDSA asserts that ELISA screening, followed by Western blot confirmation when indicated, will diagnose Lyme disease with accuracy and confidence; ILADS contends that Lyme can elude current testing methods.
- IDSA claims that the treatment regimen outlined in their guidelines is curative; ILADS states that Borrelia may survive in the body in spite of short-term courses of antibiotics.
- IDSA contends that chronic Lyme disease does not exist; ILADS points to confirmed cases of chronic Lyme disease that have responded to long-term antibiotic therapy.
IDSA Prevails
For better or worse—and for a variety of reasons—the IDSA has prevailed in the political struggle to get its guidelines into the fore: the Centers for Disease Control, the National Institutes of Health, the Institute of Medicine, and the American Academy of Neurology (AAN) have all accepted IDSA guidelines as the standard of care.
Furthermore, about a year after the IDSA published its 2006 guidelines, the New England Journal of Medicine—arguably one of the most respected journals in the medical field—published its own article refuting the existence of chronic Lyme disease.
Unfortunately, this article, which repudiated many ILADS guidelines, was authored by individuals from the IDSA. In some observers’ eyes, this represented a conflict of interest and tainted the reputation of the journal.
Finally, ILADS panelists pointed out that the American Academy of Neurology accepted IDSA guidelines only because these two committees share overlapping membership.
The Attorney General Finds That IDSA Erred
Given the irregularities in the promulgation of IDSA’s Lyme disease guidelines, Blumenthal conducted an investigation that showed serious flaws in the way IDSA had developed its policy. Citing concerns with antitrust law, rather than science, Blumenthal noted the following:
- IDSA undercut its own credibility by allowing authors with financial interests (i.e., with pharmaceutical and insurance companies, manufacturers of diagnostic tests, patents, etc.) to exclude divergent medical opinion and evidence.
- IDSA did not follow its own procedures for appointing its panel chair and membership.
- IDSA did not screen its panel members for conflicts of interest.
- IDSA’s panel did not consider information regarding the existence of chronic Lyme disease.
- IDSA blocked the participation of experts with divergent views.
- IDSA portrayed the AAN’s Lyme disease guidelines as corroborating its own when it was aware that the two panels shared membership, thus violating IDSA’s own policy regarding conflicts of interest.
It can only be hoped that the agreement framed by Connecticut’s Attorney General will lead to the development of a broader-minded approach to Lyme disease. This, in turn, may change trends within the insurance industry that currently limit access to care for a disease that is under-diagnosed in America.
At the very least, this action has served to reveal how standards of medical care can be based upon financial and political concerns, rather than science.
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