MOVED: Lyme Disease: Two Standards of care

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    Lyme Disease: Two Standards of Care (Lyme controversy) 12/02/05 02:08 AM

    Lyme Disease: Two Standards of Care

    By Lorraine Johnson, JD, MBA Executive Director, CALDA
    (California Lyme Disease Association)
    Updated February, 2005

    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. T

    he 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 is the controversy more or less).

    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.

    The findings of two studies (Klempner and Krupp) are contradictory, with one indicating that continued treatment is beneficial for treating fatigue and the other indicating that it is not.[6–8] The third NIAID-funded study has recently been completed and preliminary results support continued antibiotic treatment for patients with persistent Lyme disease.[9]

    The findings of five non-controlled studies support continued treatment.[1, 10–13] The existence of limited or conflicting controlled studies is not uncommon in the practice of medicine. 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 healthcare outcomes is to fund more research. It is estimated that only 20% of medicine practiced today is rooted in double-blind studies.[14]

    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.[15]

    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.[16]

    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.”[17]

    For treating early Lyme disease, there are conflicting surveys. Most physicians responding to one survey specified short-term treatment[18], while 43% of those responding to another survey would treat erythema migrans-positive Lyme disease for three months or more.[16] 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 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]

    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 healthcare 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 was found to reflect physician opinion. In patient preference situations, patient and provider values are often in conflict and public healthcare 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.”[21]

    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 cannot 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:

    Physicians, insurers, patients and governmental agencies are educated 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.


    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.
    Coyle, P.K., Neurologic complications of Lyme disease. Rheum Dis Clin North Am, 1993. 19(4): p. 993–1009.
    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.
    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.
    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.
    Fallon, B.A., Testimony at public hearings in re Lyme disease for the State of Connecticut Department of Public Health. 2004: p. 134–153.
    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.
    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.
    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.
    Wahlberg, P., et al., Treatment of late Lyme borreliosis. J Infect, 1994. 29(3): p. 255–61.
    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.
    Fallon, B.A., Repeated antibiotic treatment in chronic Lyme disease. J Spirochet Tick Borne Dis, 1999. 6 (Fall/Winter): p. 94-101.
    Donta, S.T., Tetracycline therapy for chronic Lyme disease. Clin Infect Dis, 1997. 25 Suppl 1: p. S52-6.
    Hitt, J., The year in ideas: a to z.; evidence-based medicine., in New York Times (December 9, 2001, Sunday).
    Hurwitz, B., Clinical guidelines and the law. BMJ, 1995. 311: p. 1517–1518.
    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.
    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.
    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.
    In the Matter of Joseph Burrascano, M.D., Determination and Order (No. 01-265) of the Hearing Committee dated November 6, 2001.
    American Medical Association, Code of Medical Ethics.
    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.

    I have broken the paragraphs down for easier reading DLL

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    UP 12/02/05 08:31 AM


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    Don'tLikeLiver -- how are you? 04/29/08 03:07 PM

    bumping up as this is still a really informative post...

    Dontlikeliver - I see you haven't posted in quite a while ---

    how are you doing??


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    I guess what bothers me most 04/29/08 03:17 PM

    Is that antibiotics are relatively cheap. They will put kids on Adderall like candy for years, give *FMS* patients Lyrica....God knows what THAT costs, and you can get Abx if you have acne. But Lyme???? Whoa..... stop right there.

    I have met ppl that have gotten better from Lyme using Rife and Samento, and Abx. I have tried both, and right now when I try to stop Abx my pain goes back out of control. I work full time and cannot afford to be on methadone and be zoned out. But I have reached the max dose of vicodin.

    Personally, I think since I am the one paying for the insurance, I should get to chose what is working for me.


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    thought provoking 04/29/08 03:33 PM

    I believe that the patient/dr relationship should decide the course of action....

    Just like if you had cancer...The dr tells you the options, the pros and cons and usually his or her opinion. Ultimately the patient makes the decision...

    I get very angy whent the Insurance companies tell someone they can't use long tern abx.

    I agree with Bunny on the point of everyone else being able to get abx. My best friends child has chronic allergies, colds sinus infections etc....She is on non-stop ABX...Why is that ok? But not ok for Lyme? Why is it ok to put a kid on abx for acne? But not for Lyme? Why is ok to put a diabetic on ABX, but not for Lyme?(My mom was a diabetic), and I would never deny her, her ABX when she had an active infection...It would have killed her...It could possibly be killing those of us with Lyme. It was worth the risk to her to take the ABX and it should be my choice to take them for my LD.

    I know, maybe they are afraid if everyone who truly has LD went on ABX they would run out. Kinda like running out of the flu shots. I bleieve there are soooooo many ppl. with LD that could be their thinking!

    Actually, I don't know what their thinking, but it doesn't make sense.

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    needed meds 04/29/08 06:13 PM

    kids can get all the adderal they want. i couldn't get adderal to work! i would prefer not to have to take it, but needed it. then i was given scripts for all this other crap. i can't believe how hard i had to scrounge and scrape for a med they hand out like candy to little kids. 47 years old, i need to work. i'm not a druggie.

    many on this board can't get decent pain meds. their docs refuse to give that to them.

    we don't get what cures us, and we can't even get what we need to manage (decently) our symptoms anymore.

    (and that's really not the most acceptable option, either but)


    why are we not screaming bloody hell?

    and did anyone stop to think that MEDICINE is simply BUSINESS?

    why do we think they can care for us and "heal" us? that's not what business does. business makes money. that's what business, or medicine, is in business for. doctors, drugs, pharma, hospitals, etc. business.

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    lies 04/30/08 10:07 AM

    your post is so how I feel.

    I don't understand nor will I ever how a bunch of people sitting around a round table, who usually aren't dr's, are making life threatening decisions for most of us.

    It's VERY frustrating.

    Definitely something needs to be done about the treatment standards and protocol for lyme.