POLITICAL ACTION: Add your name on letter to IDSA
Members of East Bay L.E.A.P.S. (Lyme Education And Patient Support) have drafted an excellent letter to the IDSA Lyme guidelines review panel. You can have your name added to it as a signer if you'd like.
To have your name added as a signer to this letter, send an email to Barbara Arnold, at firstname.lastname@example.org
From: East Bay L.E.A.P.S. (Lyme Education And Patient Support)
Dear Chairperson and Panel Members,
Thank you for the opportunity to provide input in this important review of the Treatment Guidelines for Lyme Disease. As patients, healthcare consumers, and citizens, we welcome the chance to share with you our experience with the treatment of Lyme disease under the existing guidelines. We feel there are areas in which greater attention and a broader array of treatment options are warranted.
First, we believe the current Guidelines overplay the role of themigrans (EM) rash in the diagnosis of Lyme disease. In fact, the emphasis the 2006 Guidelines place on establishing the existence of an EM rash are likely to lead the clinician to overlook the possibility of more serious neurological manifestations of the illness. We feel this is in error and imperils patients. As a practical matter, not all EM rashes can be documented. Moreover, not every Lyme-transmitting tick bite results in an EM rash. Therefore, we ask the Panel to revise the Guidelines so as to make the EM rash one factor among a constellation of clinical criteria, and not the make-or-break element put forth by the current Guidelines.
Second, we ask that the Panel reconsider the testing criteria by which Lyme disease can be diagnosed in the clinical setting. The 2006 Guidelines advocate a 2-tier system for diagnostic testing, including a first-tierand a confirmatory IgM/IgG immunoblot (a.k.a. “Western Blot”) test. We feel this system is overly restrictive, born of the more limiting standards of the research arena, and that it misses many active cases of Lyme disease. In fact, the 2006 Guidelines tacitly adopt the CDC surveillance criteria. The CDC criteria for a positive Western Blot might be appropriate for some formal studies, but using these criteria for patient diagnosis results in an unacceptable number of Lyme cases being missed. When active cases of Lyme disease go undiagnosed – and therefore untreated – patients suffer. The infection is at liberty to spread from the cutaneous bite-site to vital organs, including the brain, heart, and gastro-intestinal tract. More accurate testing criteria exist and should be used in the clinical setting. We ask the Panel to implement the testing criteria that test for a wider array of reactivity to antibody alleles (Dka bands), and also to allow for the use of PCR and culture for confirmation of suspected cases when the clinical judgment of the practitioner deems alternative tests warranted.
Third, we would like to see the revised Guidelines contain a clear and candid list of symptoms. The current Guidelines do not contain such a list. In fact, the text of the current Guidelines overemphasizes the symptoms of rashes and arthritic knees, at the expense of the more serious neurological complications of this illness. The neurological manifestations of this illness must be enumerated in an explicit fashion so as to highlight to the practitioner the serious threat that Lyme disease poses to the patient. Including a clear list of neurological symptoms will make the Guidelines more user-friendly for practitioners and awaken their consciousnesses to the dangers of the illness. We as patients have experienced directly that the popular notion among many healthcare practitioners is that Lyme is nothing more than a localized disease of the skin and knees, when the reality is quite different. The misconceptions about Lyme disease have been imperiling patients and the public health for decades. The result is that active cases of neurological Lyme are being overlooked and dismissed out-of-hand. In turn, patients go untreated and the infection continues its savage work on the nervous system, including the white matter of the brain. This Panel is in a position to put an end to this serious omission.
Fourth, we ask that the Panel remove from the Guidelines any mention of tick-attachment time as a prerequisite for diagnosis and treatment. The 2006 Guidelines state that 36 hours is required before tick-to-human transmission of the pathogen can take place. Putting aside the practical problem of ascertaining how long a tick has been attached to its human host, there exists evidence to indicate that transmission can occur quite readily. Inspection of the study cited in support of the 36-hour rule reveals that transmission occurred in 1 in 14 animals in less than 24 hours. A risk/cost/benefit analysis for prophylactic treatment should reflect this 1 out of 14 chance, instead of mistakenly regarding transmission risk for short tick attachment durations as negligible. Moreover, since it is often difficult to ascertain how long a tick has been attached to its human host, we ask that the Panel revise the Guidelines so as to allow for treatment in any case where a tick bite has taken place.
Fifth, we ask that the Panel eliminate the distinction between “major” and “minor” symptoms as put forth in the 2006 Guidelines. We ask that the Panel allow for the severity of symptoms to be assessed in the clinical environment. We particularly take issue with the assertion in the 2006 Guidelines that fatigue and pain (arthalgias) can only be regarded as “minor” in the existing framework. Symptoms such as myalgia (i.e., muscle pain), nerve pain and dysfunction, and should be included in the revised Guidelines. As patients, we have experienced these symptoms as devastating. Our experience indicates that they are significant clinical signs of an underlying disease process that should be recognized and taken seriously. The rigid division of symptoms into “major” and “minor” subsets has led healthcare practitioners to ignore these important factors in making a diagnosis. Again, when the patient goes undiagnosed and untreated, the disease is left to advance unchecked. Furthermore, with regard to , we ask that the Panel’s enactment of new guidelines allow for the use of SPECT scans.
Sixth, we ask that the Panel recognize that Lyme disease can be fatal, and to make mention of this possibility in the revised Guidelines. As Lyme patients, many of us have experienced the loss of friends and colleagues. We ask that the revised Guidelines make mention of this possibility so that healthcare practitioners can be advised that, among the possible outcomes of a Lyme infection, fatalities – whether rare or common – are nonetheless real.
Seventh, we ask that the Panel remove the distinction between “early” and “late” disseminated disease, as put forth by the 2006 Guidelines. Even the Guidelines authors concede that maintaining this distinction is more “customary” than “pathophysiological.” As patients, our experience counsels that maintaining this distinction is harmful. The early/late classification gives to the healthcare practitioner the impression that if treatment is instituted early, it can be both brief and at a low dose in order to be complete. As a result, treatment is sometimes curtailed too soon, to the detriment of the patient. We believe that the “early” and “late” classification is more than just a quaint holdover from an earlier conceptual framework. This distinction is harming patients by encouraging practitioners to treat according to an orthodox timetable, rather than according to symptomology.
Eighth, we ask that the Panel re-evaluate the classification of “Post-Lyme Syndrome” in its entirety. We ask that the Panel recognize the possibility that Lyme infection can persist in the human body beyond the restrictive timelines set forth in the 2006 Guidelines. There is ample proof to warrant the recognition of persistent Lyme infection, and to eliminate (or at least to re-contextualize) the classification of “Post-Lyme Syndrome.” Studies have confirmed the presence of /Borrelia/ /burgdorferi/ spirochetes in the brains, cerebro-spinal fluid, and/or other tissues of patients with persistent symptoms related to Lyme disease. In particular, Oksi et al. cultured spirochetes from Lyme patients. This is significant given the fact that the authors of the 2006 Guidelines insist that culture is the “gold standard” of proof. Theories of pathogen sequestration, genetic polymorphism, and cyst-formation could account (either singly or in combination) for the persistence of Lyme infection in the human host. The multiplicity of strains of /Borrelia/ /burgdorferi/ may also contribute to persistence of infection and the 2006 Guidelines fail to address this possibility. We ask the Panel to recognize that when symptoms persist in the patient, it is at least possible that infection persists. Where this is a possibility, practitioners should be allowed to treat patients accordingly, i.e., with antibiotic therapy through to the resolution of symptoms and/or negative serology under the revised standard. Furthermore, we ask that the Panel recognize that the theory of “Post-Lyme Syndrome,” espoused by the 2006 Guidelines authors, relies upon the hypothesized existence of auto-immune dysfunction. This hypothesis relies, in turn, upon the existence of an auto-antigen. We ask the Panel, if it should choose to include discussion of “Post-Lyme Syndrome” in the revised Guidelines, that it also include a discussion of the underpinnings of this theory, and that it mention that the existence of the alleged “auto-antigen” has never been demonstrated.
Lastly, the current Guidelines make no distinction between people whose illness has been diagnosed soon after initial infection and those who have harbored the infection for a long period of time. The existing Guidelines make no allowances for varying treatment so that patients with more severe symptoms can be treated more robustly than those with less intense symptoms. We believe the Panel in establishing revised Guidelines should make allowances for longer, more intense treatment for patients with longer, more intense symptoms.
Thank you for your consideration in this important matter. We hope the above statements shed light on the nature of Lyme disease from the patient perspective, and that they assist you in your work on revising the Treatment Guidelines. Our experience as patients and caregivers has taught us that Lyme disease is a serious infection that can be remedied with appropriate treatment, particularly antibiotics. We hope the Panel will revise the Guidelines to address the above concerns, so that patients like us and in the future can receive thorough, timely, and relevant care.
(names will be added here)