Lyme Disease

Currently, the best test for Bb measures antibodies our body makes against this microorganism. While it may sound as though this test can easily spot Bb, it does not. This test focuses on a single strain, B31, which is mainly associated with arthritic symptoms. However, there are 12 known genospecies. One of these genospecies has over 100 strains in the United States and 300 strains worldwide. These are not included in the current test. For this reason, less than one 1 out of 2 people who have Lyme have a positive test.

Because of the testing problems, The Centers for Disease Control (CDC) has advised physicians that Lyme disease should be diagnosed based on the patient’s clinical symptoms and not the laboratory test. The laboratory test is used to report cases to the CDC, which is much different from treating a sick person. It is the experience of the healthcare providers at Priority Health that if a patient:

Exhibits many of the clinical symptoms (see above) AND other treatments for some of many of the symptoms have failed AND antibiotic therapy that has worked well with hundreds of our previous Lyme patients is begun AND the patient responds well to the antibiotic therapy, there is a high degree of likelihood that the patient is infected with one or more strains of Bb not identified by currently available tests.

While not nearly as prevalent in the Carolinas as in the Northeastern states, Lyme disease certainly exists in our state, particularly along with coast and Piedmont areas. Also, an estimated two million new residents moved to the Carolinas from 1995-2005 and 60% came from the top 15 Lyme-endemic states, including Pennsylvania, Connecticut and New York. Many unknowingly bring chronic Lyme with them.

There is much to understand, and much that is not known, about Lyme disease. In very general terms, Bb is very smart; it is immune-evasive and has the ability to survive under unfavorable conditions. It can hide within the body’s cells to avoid detection and elimination by the immune system. When the Bb is stressed by lack of food or a change in pH, for example, it can then change its form into a cyst which enables it to be protected until conditions are optimal. If it is left on its own, it can interfere with the normal functioning of many organs including the musculo-skeletal system, the gut and bladder and the brain. Bb is particularly fond of brain tissue, hence the dramatic neurological changes in patients with Lyme. Well-known author Amy Tan has made many public statements about her declined ability to perform everyday functions. While she is profoundly better from her treatment, she has been left with some diminished neurological functions.

The treatment guidelines that were drafted by the Infectious Disease Society of American (IDSA) and adopted by the CDC and most, if not all, health insurance companies, call for 30 days of antibiotic treatment for chronic Lyme disease. There has never been a study demonstrating that 30 days of antibiotic treatment cures chronic Lyme. On the contrary, much medical literature has been published in both the United States and Europe demonstrating that short courses of antibiotic treatment fail to eradicate the Lyme bacteria and that short treatment courses result in upwards of a 40% relapse rate, especially if treatment is delayed.

The International Lyme and Associated Diseases Society (ILADS) has advocated a second standard of care that differs from the IDSA standard of care. ILADS and its members have advocated for the following changes to be made to those guidelines promulgated by the IDSA and CDC:

Since there is currently no definitive test for Lyme disease, laboratory results should not be used to exclude an individual from treatment Lyme disease is a clinical diagnosis and test should be used to support, rather than supersede the physician’s judgment. The early use of antibiotics can prevent persistent, recurrent and refractory Lyme disease.

The duration of therapy should be guided by clinical response, rather than by an arbitrary (i.e., 30 day) treatment course.

By adopting these changes, physicians will no longer fear prosecution from their medical boards for treating Lyme beyond 30 days, patients will no longer be denied care and they will no longer have to battle their insurance companies for coverage of treatment.

There is much more to know about Borrelia Burgdorferi and the treatment of chronic Lyme disease. Doctors within ILADS and infectious disease colleagues from around the country wrote to the IDSA in October 2005 and asked to be part of the panel that is currently reviewing the treatment guidelines. To date, a response has not yet been received.

Dr. Saleeby and his staff have been pleased to note that with their work of providing life-altering therapeutic intervention, their patients’ quality of life is often restored. In the process, much as been learned about treatment methods and treatment response.

This information, along with what other Lyme-treating physicians around the country have learned, is all tremendously useful in understanding more about this debilitating illness and in providing more efficient and durable treatment.

More information on Lyme disease:

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

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.

For Local Groups:

lymenet.org This site allows one to search by state for a support group in their community.
*Carolina Holistic Medicine is looking into establishing a local Myrtle Beach area Lyme support group. Keep posted.

lymeinfo.net This site features support groups that each have a website. Some of these are local groups, and others are online groups.

lymedisease.meetup.com This site is for finding a local meet up group, where one can meet with local people affected by Lyme disease for discussion, information, and support.

Online (Virtual) Support Groups:

www.lymenet.org/SupportGroups/Internet This site lists online support groups; some of these are by categorized by location.