Sunday, December 2, 2012

Chronic Lyme Disease Is A Treatable Illness

Canadian Lyme Disease Foundation
2495 Reece Rd., Westbank, BC V4T 1N1
Ph: 250-768-0978     Fax: 250-768-0946                                                                          
Charitable Reg #  864437603RR0001           

Honourable Dr. Margaret MacDiarmid                                         Oct 30th, 2012
Minister of Health
Room 337, Parliament Buildings
Victoria, BC
V8X 1 X4

Dear Minister MacDiarmid,

Congratulations on your appointment as Minister of Health – we wish you every success in this new and demanding role, no doubt one of the hardest assignments in government. We commend you for taking it on.

One of the many challenging files you face is Lyme disease, which in CanLyme’s view is poorly diagnosed and under-treated in B.C. and across Canada. CanLyme is a volunteer-led national charity whose mission is to further scientific analysis of vector-borne disease, improve diagnosis and treatment of Lyme disease (Borrelia burgdorferi) and co-infections, and ensure that the patient’s experience is factored into the design of public health policies affecting treatment.

This mission positions us as critics of BC’s public health bureaucracy, who advocate the IDSA guidelines on Lyme disease and resist any modification whatsoever. Minister, with great respect, we are dismayed by the refusal of these officials to take seriously any evidence that differs from the official narrative on this troubling but treatable illness. Continuing insistence, despite clear scientific evidence to the contrary, on the correctness of these tightly drawn guidelines stands in the way of progress in detection and treatment of Lyme.

We give as an example provincial health officer Dr. Perry Kendall’s blanket assertion that a chronic form of Lyme disease does not exist (Letter, Times Colonist, July 7, 2012). Given available science, this cannot be stated categorically, and yet it is being used to frame policies that withhold treatment for chronic Lyme sufferers. For those whose disease was missed initially or persisted after the approved short course of treatment, denial of chronicity bars the door to further care. We would also respectfully suggest that this belief is at odds with your own government’s progressive choice to include chronic Lyme disease in the work of the BC Chronic Complex Diseases Clinic.

Dr. Kendall says that lingering symptoms after a short course of antibiotics are merely an auto-immune reaction, and are “not persistent infection”.  This assertion is contradicted by much scientific evidence.  Dr. Brian Schmidt of BC’s Provincial Health Services Authority pointed this out in his review (2010) of chronic Lyme disease for John Dyble, then-DM of Health. He notes the “growing evidence that LD is a persistent infectious disease,” for which “no reliable test exists”. If in fact Lyme bacteria can survive as active infection after the IDSA treatment limits, then people with persistent symptoms may benefit from the longer courses of antibiotics these guidelines refuse. It is certainly our experience that patients who eventually do secure longer term treatment see their symptoms resolve and quality of life improve; yet clinical evidence of return to health by patients is dismissed as merely anecdotal.

Dr. Schmidt also noted that the current trend of scientific research supports the existence of chronic Lyme disease. The most recently published study, Persistence of Borrelia burgdorferi in Rhesus Macaques following Antibiotic Treatment of Disseminated Infection (Embers et al, PLOS ONE, 2012) offers firm evidence of active infection after treatment to IDSA maximums. This confounds the claim that borreliosis is strictly a self-limiting disease, which after running its course (or after at most a month’s therapy) leaves damage in its wake but is no longer active infection. Closing the door to further treatment based on false assumptions is not good public health policy.

Dr. Kendall also follows the IDSA in asserting that there’s no evidence of improvement with further antibiotic treatment, a claim resting on interpretations of four NIH-sponsored randomized, placebo-controlled studies of efficacy. Two new reviews of these four studies conclude that as a result of numerous methodological flaws, the Klempner et al studies are underpowered to detect clinically meaningful results.  “The trials, as designed, called for treatment effects considerably larger than the minimum clinically important differences (MCID) identified in other chronic illnesses, suggesting that the sample sizes were inadequate and the trials were very likely underpowered to detect the true underlying MCIDs,” Antibiotic retreatment of Lyme disease in patients with persistent symptoms: A biostatistical review of randomized, placebo-controlled, clinical trials, Delong et al, Contemporary Clinical Trials, Volume 33, Issue 6, November 2012.

Fallon et al in their review of the US clinical trials on chronic symptoms note that the IDSA guideline writers conclusions that “antibiotic therapy has not proven to be useful”, that “prolonged antimicrobial treatment is ineffective” and that such treatments have “not shown sustained benefit” are not supported by the findings of Krupp et al. Closer reading shows that while Krupp et al didn’t recommend IV Ceftriaxone for retreatment due to its potential for “adverse effects”, the study in fact demonstrated “a significant clinical benefit for repeated antibiotic therapy on a key primary outcome measure” (fatigue: 64% drug compared to 18.5% placebo overall, 80% versus 13% in the more homogeneous subgroup of IgG Western blot-positive participants).

 “Treatment guidelines that dismiss the research findings as showing no efficacy do an injustice to the evidence and are not helpful to clinicians and patients. For example, a clinician with a patient suffering from disabling post-Lyme fatigue would want to know that the clinical trials provided divergent results to enable a thoughtful discussion of the risks and benefits of repeated antibiotic therapy, as a patient with severe fatigue may decide that the potential benefit of sustained improvement outweighs the risks.” Fallon et al, A Reappraisal of the U.S. Clinical Trials of Post Treatment Lyme Disease Syndrome, Open Neurology Journal, 2012.

The IDSA-cited studies do not in fact prove what their guidelines assert, ie. that retreatment lacks efficacy; accordingly, they should not be used to rationalize barring the door to it. While doctors in BC are not legally prohibited from treating beyond these guidelines, categoric statements (like those of the BC CDC’s Dr. Henry, dismissing patient progress with ongoing antibiotics as “placebo effect”) imply that peer-reviewed science supports the claim of inefficacy. As a result of this ideological marshalling of disproven claims, the message to doctors is that it’s all in the patient’s head and there’s no benefit to retreatment.

CanLyme also takes issue with the test BC inappropriately uses (according to the US CDC’s criteria) to categorically rule out Lyme disease. We have documented some of the test’s weaknesses in an email to a BC Deputy Provincial Health Officer (Sperling, August 2008). We have also tried to bring instances of misdiagnosis and refusal to treat to the attention of Drs. Kendall and Henry. In such cases, patients with evidence of a tick bite, a bulls-eye rash (diagnostic of Lyme), and typical acute symptoms, are improperly made to take the BC test and then refused all treatment if it’s negative (as it nearly always is). Eventually retested positively in the USA, and frequently found to have serious co-infections that BC doesn’t test for, many such debilitated people do gradually recover their health. Madame Minister, the very existence of cases of EM rash testing negative should raise alarm bells about the accuracy of BC’s Lyme test, yet the BC CDC continues to tell doctors that it’s virtually 100% reliable and turns a blind eye to its being used to rule out Lyme diagnosis.

Dr. Kendall also expresses certainty, based on assurances from unnamed microbiologists, that BC’s existing Lyme test picks up “all five strains of borellia [sic] found in BC.” Respectfully, this claim lacks credibility – we are aware of no published studies that provide any basis for it whatsoever. There are however clear indications from Canadian scientists (Ogden et al, 2008, 2011) that make such a claim highly improbable. Ogden has warned several times now that provinces need to be alert to rapidly diversifying local strains of Bb that may be missed with current serological tests. The level of confidence expressed by Drs. Kendall and Henry in BC’s current test means that GPs are encouraged to trust a diagnostic device that Dr. Schmidt concluded was "unreliable" and required urgent replacement (BC’s “first and highest priority”).

Dr. Schmidt also noted that our GPs are reluctant to treat beyond the IDSA guidelines because these have been elevated to best-practice status. He recognized that this means those with persistent infection are typically left out in the cold; he also noted that in response to similar circumstances in a private healthcare system, five US states have now passed laws protecting doctors who treat Lyme with longer courses of antibiotics from any disciplinary action by regulatory bodies. Dr. Schmidt recommends that our clinicians be reminded of their rights, under BC’s health professions legislation, to practice complementary medicine, so that they are aware that should they deem a longer course of therapy to be potentially beneficial, they are free to undertake it in consultation with their patients.

Madame Minister, Lyme disease continues to spread across BC and is routinely being missed by BC’s two-step test. We are urging that you review and act on Dr. Schmidt’s recommendations on Lyme disease, starting with ensuring that willing physicians know they can treat Lyme as a bona fide chronic illness. This step is needed to counter the chill on retreatment systemically induced among doctors by overly restrictive guidelines. It will take a Minister of Health informing the appropriate professional and public health entities, along with all our doctors, that they enjoy rights as licensed clinicians to make medical judgments about treating chronic Lyme disease with antibiotics. Freeing doctors to practice medicine using their trained judgment begins by recognizing publicly that chronic Lyme is a bona fide infectious disease that is in fact treatable.

Minister, we are asking you to distinguish yourself by taking that public step, so that Lyme-infected British Columbians are no longer denied access to relief of their suffering.

Sincerely yours,

David Cubberley
Jim M. Wilson,

This blog is about the rise of Lyme disease and other tick borne infections, in British Columbia and across Canada, and the failure of public health agencies to adequately warn and protect the public from this debilitating disease. Its purpose is to alert people to a danger that increasingly surrounds them, in the outdoors and in their backyards, and to pressure government, opinion leaders and public health officials to reform the medical framework for Lyme disease diagnosis and treatment. Today, due to faulty tests, lack of physician knowledge and inadequate treatment protocols, many patients are being forced to live with a devastating chronic illness rather than being given medically necessary care. Most have to travel to the United States to purchase healthcare they are entitled to under law in Canada, but currently denied. Many people are living in poverty as a result of personally financing antibiotics, which are the sole control and cure for chronic Lyme disease. This blog discusses issues and offers resources relating to Lyme disease diagnosis and cure. It aspires to be an instrument of change.