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. Without such markers, it is difficult to determine who has the disease, the effectiveness of a course of treatment, and the end point of treatment. The ideal antibiotics, route of administration, and duration of treatment for persistent Lyme disease are not established. No single antibiotic or combination of antibiotics appears to be capable of completely eradicating the infection, and treatment failures or relapses are reported with all current regimens, although they are less common with early aggressive treatment. [1-3]
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. This split has resulted in two standards of care. Both viewpoints are reflected in peer reviewed “evidence-based” guidelines. Some physicians treat patients for 30 days only and assume that remaining symptoms reflect a self-perpetuating autoimmune response. [4] Other physicians assume that the persistent symptoms reflect on-going infection and gauge the duration of treatment by the patient’s individual clinical response. These physicians believe that there is insufficient evidence at this point to adopt standardized treatment protocols. [5]
While each viewpoint has a strong underlying hypothesis, the scientific evidence supporting either viewpoint is equivocal. Outcomes research is limited and conflicting. The NIAID has only funded three double-blind placebo-controlled treatment outcome studies for long-term treatment of persistent Lyme disease. One study is ongoing (Fallon), and the findings of the other two studies (Klempner and Krupp) are contradictory, suggesting that the study populations are enormously heterogeneous.[6-8] The findings of non-controlled studies yield contradictory results as well. Where this is the case, the unique clinical course of the patient, of necessity, bears the laboring oar in treatment decisions.
Insurance companies have placed 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.” The point, of course, is that the science underlying both the short term and the longer term treatment options is equally uncertain (like prostate cancer). The appropriate response to equivocal research findings in health care outcomes is to fund more research.It is estimated that only 20% of medicine practiced today is rooted in double-blind studies.[9] The bulk of medicine today is practiced in the grey zone. 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.[10] Moreover, more than one standard of care may exist. A number of surveys have found a fairly even split among treating physicians. One survey found that 57% of responding physicians treat persistent Lyme disease for three months or more.[11] Fallon notes that for over 3400 patients screened for the Columbia University study of persistent Lyme disease, the mean duration of IV treatment was 2.3 months and the mean duration of oral antibiotic therapy was 7.5 months.[6] In another survey, "50% of the responders considered using antibiotics for a time greater than one year in a symptomatic seropositive Lyme disease patient. Almost that same number would extend therapy to 18 months if needed".[12] For treating early Lyme disease, there are conflicting surveys. Most physicians responding to one survey specified short term treatment [13], while 43% of those responding to another survey would treat EM-positive Lyme disease for three months or more.[11] All jurisdictions that have considered the matter have found two standards of care in the treatment of Lyme disease.[14, 15]
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 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).[16] For example, patients with prostate cancer (where significant uncertainty exists regarding long term treatment outcomes) must elect between watchful waiting, radiation and surgery. The legal doctrine of informed consent also requires that patients be advised of material treatment options. Treatment choices involve trade-offs between the risks and benefits of treatment options that only patients—who know the kinds of risks they are willing to run and the types of quality of life outcomes that matter to them—are uniquely suited to make.
Sound health care policy follows suit, with health care costs generally witnessing a reduction when the patient’s preference is supported. Patient preference exists whenever there is more than one acceptable treatment approach. When inefficiencies in the Medicare system were analyzed by looking at small area variations in medical practice, most variation in preference-sensitive care reflect was found to reflect physician opinion. In patient preference situations, patient and provider values are often in conflict and public health care researchers recommend reducing the medical practice variations in these situations by “reduc[ing] scientific uncertainty through outcomes research..… and establish[ing] shared decision making for preference-based treatments.”[17]
Respect for the basic autonomy of the patient is a fundamental principle of medical ethics. Without adequate information about treatment options, their probable outcomes, and the risks and benefits associated with each, patients can not act autonomously. Today, however, many patients are either denied treatment by their HMO physicians who follow actuarial treatment protocols generated to keep treatment costs down, or they must find an independent physician to treat them, with the all but forgone conclusion that coverage for this treatment will be denied by their insurer based on cherry picked (economically favorable) guidelines. Moreover, HMO physicians generally do not advise their patients that treatment alternatives exist.
Scientific uncertainty about Lyme
disease has resulted in more than one treatment approach (like prostate
cancer). We agree with the AMA, ACP and other professional medical
organizations interested in promoting informed patient consent and want to make
sure that:
1. 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.
2. Coyle, P.K., Neurologic complications of Lyme disease. Rheum Dis Clin North Am,
1993. 19(4): p. 993-1009.
3. 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. 4. 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.
5. The International Lyme and Associated Diseases Society (ILADS), Evidence-based guidelines for the management of Lyme disease. Expert Rev Anti-infect Ther, 2004. 2(Suppl): p.S1-S13.
6. Fallon, B.A., Testimony at public hearings in re Lyme disease for the State of Connecticut Department of Public Health. 2004.
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.
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.
9. Hitt, J., The year in ideas: a to z.; evidence-based medicine., in New York Times (December 9, 2001, Sunday).
10. Hurwitz, B., Clinical guidelines and the law. BMJ, 1995. 311: p. 1517-1518.
11. 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.
12. 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.
13. 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.
14.In the Matter of Joseph Burrascano, M.D., Determination and Order (No. 01-265) of the Hearing Committee dated November 6, 2001.
15. Natole v. Michigan Board of Medicine, (File no. 96-015560 AA-2) (1998) .
16. American Medical Association, Code of Medical Ethics.
17. Wennberg, J.E., E.S. Fisher, and J.S. Skinner, Geography and the debate over Medicare reform.
Health Aff (Millwood), 2002. Supp Web Exclusives: p. W96-114.
Footnotes
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=10442678.
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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=10982743.
http://www.ilads.org/.
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