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Lyme Disease and Two Standards of Care

Two Standards of Care

Opinion within the medical community is deeply divided regarding the best approach for treating Lyme disease, particularly persistent Lyme disease that is not cured by short-term protocols. Some physician groups recommend short term antibiotic therapy; if symptoms persist, they assume that these reflect a self-perpetuating autoimmune response. [1] Others assume that the persistent symptoms reflect on-going infection and gauge the duration of treatment by the patient’s individual clinical response. The latter believe that there is insufficient evidence at this point to adopt standardized treatment protocols. [2]

The central difficulties in the diagnosis and treatment of Lyme disease stem from the lack of sufficiently sensitive and reliable biological markers of the disease. The complexity of the disease is also at question; many who treat patients regularly believe that much remains to be learned. Without something as basic as markers for disease status, it is difficult to determine who has the disease, the effectiveness of a course of treatment, and the end point of treatment. [3-5]

The scientific evidence supporting either viewpoint is unresolved and in dispute. Outcomes research is limited and conflicting. The National Institute for Allergy and Infectious Diseases (NIAID) has only funded three double-blind, placebo-controlled treatment outcome studies for long-term treatment of persistent Lyme disease. The findings of two studies (Klempner and Krupp) are contradictory.[6-8] The preliminary results of the recently completely third NIAID-funded study support continued antibiotic treatment.[9] The findings of five non-controlled studies support continued treatment.[1, 10-13]

Insurance companies have a history of placing the full weight of their economic clout behind the less expensive short-term treatment protocols. More expensive longer-term treatment options are discredited as “experimental” or “not evidence-based.” We would suggest that such logic is self serving to the insurer, as it is estimated that only 20% of medicine practiced today is rooted in double-blind studies.[14] Furthermore, evidence-based medicine requires only that medicine be practiced in accordance with the evidence that currently exists, not that treatment be withheld pending research. Insurance companies have adopted guidelines reflecting short-term treatment approaches. However, the legal standard of care for treating a condition is determined by the consensus of physicians who actually treat patients, not by treatment guidelines.[15] It is a sad irony that the group of individuals who craft the Lyme Guidelines for the IDSA rarely treat the sort of complex patients for whom they prescribe guidelines for care; to wit, the patient complexity is certainly not reflected in their reports, and the lines between acute and chronic illness are blurred.

In the treatment of Lyme borreliosis, a number of surveys have found a fairly even split among treating physicians between longer and shorter treatment. (6, 16-18) All jurisdictions that have considered the matter have found two standards of care in the treatment of Lyme disease.[19] When more than one standard of care exists, the critical question becomes who decides the appropriate course of treatment for the patient. Under the medical ethical principle of autonomy, the treatment decision belongs to the patient. Hence, the American Medical Association (AMA) requires that the physician disclose and discuss with the patient not only the risks and benefits of the proposed treatment, but also the risks and benefits of available alternative treatments (regardless of their cost or the extent to which the treatment options are covered by health insurance).[20]

As with certain other diseases (for example, prostate cancer), scientific uncertainty about Lyme disease has resulted in more than one treatment approach. We agree with the AMA, the American College of Physicians, and other professional medical organizations interested in promoting informed patient consent. We need to ensure that:

  • Physicians, insurers, patients and governmental agencies understand that two treatment approaches exist;
  • Physicians give patients sufficient information about treatment options to enable patients to make a meaningfully informed choice and respect the autonomy of that choice;
  • Insurance reimbursement be provided for treatment rendered in accordance with either standard of care; and
  • Government agencies provide unbiased information and remain neutral regarding both standards of care and treatment approaches.

 

Adapted from “Lyme disease: Two Standards of Care” by Lorraine Johnson, JD, MBA, Executive Director, CALDA.

References:

  1. Wormser, G.P., et al., Practice guidelines for the treatment of Lyme disease. The Infectious Diseases Society of America. Clin Infect Dis, 2000. 31 Suppl 1: p. 1-14. www.ncbi.nlm.nih.gov.
  2. The International Lyme and Associated Diseases Society (ILADS), ILADS Evidence-based guidelines for the management of Lyme disease. 2003. www.ilads.org.
  3. Oksi, J., et al., Borrelia burgdorferi detected by culture and PCR in clinical relapse of disseminated Lyme borreliosis. Ann Med, 1999. 31(3): p. 225-32. www.ncbi.nlm.nih.gov.
  4. Coyle, P.K., Neurologic complications of Lyme disease. Rheum Dis Clin North Am, 1993. 19(4): p. 993-1009. www.ncbi.nlm.nih.gov.
  5. Hunfeld, K.P., et al., Standardised in vitro susceptibility testing of Borrelia burgdorferi against well-known and newly developed antimicrobial agents–possible implications for new therapeutic approaches to Lyme disease. Int J Med Microbiol, 2002. 291 Suppl 33: p. 125-37. www.ncbi.nlm.nih.gov.
  6. Fallon, B.A., Testimony at public hearings in re Lyme disease for the State of Connecticut Department of Public Health. 2004: p. 134-153. www.cslib.org.
  7. Klempner, M.S., et al., Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. N Engl J Med, 2001. 345(2): p. 85-92. www.ncbi.nlm.nih.gov.
  8. Krupp, L.B., et al., Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial. Neurology, 2003. 60(12): p. 1923-30. www.ncbi.nlm.nih.gov.
  9. Fallon, B.A. Laboratory findings in chronic Lyme disease and results of the controlled treatment study. in Columbia University/LDA’s Lyme & Other Tick-Borne Diseases:Technology Leading the Way Conference. 2004. Rye Town, NY.
  10. Wahlberg, P., et al., Treatment of late Lyme borreliosis. J Infect, 1994. 29(3): p. 255-61. www.ncbi.nlm.nih.gov.
  11. Oksi, J., J. Nikoskelainen, and M.K. Viljanen, Comparison of oral cefixime and intravenous ceftriaxone followed by oral amoxicillin in disseminated Lyme borreliosis. Eur J Clin Microbiol Infect Dis, 1998. 17(10): p. 715-9. www.ncbi.nlm.nih.gov.
  12. Fallon, B.A., Repeated antibiotic treatment in chronic Lyme disease. J Spirochet Tick Borne Dis, 1999. 6(Fall/Winter): p. 94-101.
  13. Donta, S.T., Tetracycline therapy for chronic Lyme disease. Clin Infect Dis, 1997. 25 Suppl 1: p. S52-6. www.ncbi.nlm.nih.gov.
  14. Hitt, J., The year in ideas: a to z.; evidence-based medicine., in New York Times (December 9, 2001, Sunday).
  15. Hurwitz, B., Clinical guidelines and the law. BMJ, 1995. 311: p. 1517-1518.
  16. Ziska, M.H., S.T. Donta, and F.C. Demarest, Physician preferences in the diagnosis and treatment of Lyme disease in the United States. Infection, 1996. 24(2): p. 182-6. www.ncbi.nlm.nih.gov.
  17. Katzel, J., Is there a consensus in treatment of Lyme Borreliosis?, in Lyme Disease 1991 Patient/Physician Perspectives from the U.S. & Canada, L. Mermin, Editor. 1992.
  18. Murray, T. and H.M. Feder, Jr., Management of tick bites and early Lyme disease: a survey of Connecticut physicians. Pediatrics, 2001. 108(6): p. 1367-70. www.ncbi.nlm.nih.gov.
  19. In the Matter of Joseph Burrascano, M.D., Determination and Order (No. 01-265) of the Hearing Committee dated November 6, 2001. w3.health.state.ny.us.
  20. American Medical Association, Code of Medical Ethics. www.ama-assn.org.

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