Where Does One Turn?

 

Negative result on a faulty test = no treatment for Lyme

 

Recently I watched TV celebrity Yolanda Foster describing the experience of living with undiagnosed Lyme disease. It’s a moving testament to both the suffering Lyme infection causes and the return of hope that comes with diagnosis and treatment. Misdiagnosed with chronic fatigue syndrome (as many with Lyme are) Yolanda fell extremely ill before an overseas specialist accurately diagnosed her and began treatment with antibiotics. While not yet fully recovered, she’s come a long way and is now advocating for reliable diagnostics and treatment, so others aren’t forced down the same path to a living hell.  

I was struck by the question Yolanda asks towards the end of the video (paraphrased here): “Where does one turn when we lack proper diagnostic testing, and people are sent away with drugs that only mask their symptoms rather than being treated and cured?” Where does one turn indeed, when abandoned by healthcare? Where does one turn when treatment is refused based on faulty test results? The unreliability of current testing is the nub of the problem we face, because when doctors can't or won’t clinically diagnose Lyme disease, they rely on the test to sort it out. So even if the patient has a bullseye rash, or is informed enough to request  that Lyme be considered on the basis of symptoms, doctors tend to default to the test to resolve matters definitively. Problem is, this test can be definitively wrong. And if the test doesn’t find Lyme, then under current practise guidelines the patient doesn’t have Lyme by definition, and can be refused treatment! And the current test is oh-so-very good at not finding Lyme! 

Unfortunately, most people who do get Borrelia burgdorferi, a bacterial infection, have just this experience with a GP, who either dismisses the possibility of Lyme outright, attributes the symptoms to another cause, or calls for the step-one ELISA test to do his/her thinking. Once a patient gets a negative ELISA, the care-door slams tightly shut and the patient is left to suffer anonymously, even here in pay-with-your-care-card Canada. In practice, it means that the antibiotics you need right away are withheld from you, today, tomorrow, and for good! And you the infected patient are now ‘free’ to go away and become very, very debilitated. Of course, the luminaries who oversee our public health framework all profess full confidence that the ELISA is up to the mark and can be depended upon to sort out who does and doesn’t have Lyme. It’s so sensitive, we’re told, that it may even produce some false positives, meaning that some who show positive don’t actually have it. And that is why the few who do show positive have to ‘prove’ they have the disease by passing a second test, the Western blot – something that maybe ten people do on average per year in all of tick-ridden BC.

It’s interesting that the US Centres for Disease Control, which endorses this poorly conceived test, state clearly (if quietly) that it's not appropriate for diagnostic use, but only as a surveillance tool to monitor disease incidence in broad populations. The CDC’s disclaimer should put responsible public health officials on high alert, because this is the very test that’s made central in diagnosing Lyme disease under the flawed Infectious Diseases Society of America (IDSA) guidelines – which our officials embrace, fully and completely. Confidence in the test comes from accepting the logic of the IDSA approach to guideline writing, which Canadian public health officials chose to do without due diligence on their part - they simply became fans and defenders of guidelines they did not trouble to verify professionally. This certainly pleases their allies in the field of infectious disease medicine, who themselves have adopted these absurdly restrictive guidelines with all the fervor of people who make money from private medicine. In fact, the IDSA guidelines come with a garnish of science, but aren’t really scientific at all, if by science we mean respect for verifiable truths identified using reproducible methods and whose analysis stands up to scrutiny by peers. These guidelines are an amalgam of statements designed to sound like science, and written so as to appear to be based on some sort of scientific concensus, but this is a contrived illusion cultivated by a handful of IDSA types who appear to enjoy close links to the American private health insurance business. Interestingly, even in Canada, most infectious disease doctors appear to do work privately for the same American health insurance companies (the kind that hold our supplementary medical insurance benefits, which we might need to use to pay for meds or homecare for treatment of Lyme disease). 

Here in BC, despite the occasional half-hearted declaration that Lyme disease should be a clinical diagnosis (from symptoms, not from a test), the BC CDC pretty much hews to the party line on Lyme disease, as does the College of Physicians and Surgeons, the extremely powerful body that controls medical licensing. So the Lyme test, which is based solely on strain B31 of Bb, identified back about 1982, (and only one of more than a dozen strains of the disease we know about) sails along not finding Lyme disease almost everywhere it’s used. And this failure to find Lyme serves to feed the Canadian fiction that there’s no Lyme about. (Relying on strain B31 isn't just like looking for needle in a haystack, it's like picking the wrong haystack to look in.) A test that rarely finds Lyme perversely supports the claim that Lyme disease is mostly an imagined illness, which in turn feeds the whisper campaigns the infectious disease docs and their public health cronies set in motion about British Columbians who claim to have Lyme disease ('imaginary disease', 'it's all in their heads', 'they may be sick, but it's not Lyme').  And that in turn supports the notion that any doctors who dare to treat these 'nutters' are medically incompetent and should be chased out of practice. 

When you look into it, the way the Colleges of Physicians and Surgeons across Canada quietly harass competent physicians who develop any treatment knowledge of Lyme disease appears more like a witch-hunt in the Soviet Union before glasnost and perestroika than a process in a democracy! Self-governing professional societies operating beyond public scrutiny, in league with public health officials who've made policy without due diligence, threaten the licences of physicians who practice medicine based on clinical diagnosis of illness (exactly what they are trained to do). South of us, in the USA, insurance companies brazenly prompt complaints to state medical boards against physicians who dare to treat patients with antibiotics for chronic Lyme disease. With the fervor of an Igor Lysenko, IDSA types engage in public denunciations of doctors who dare to believe that chronic Lyme exists and that it responds to antibiotic therapies. Denunciations. Show trials. De-licencing of doctors for practicing medicine. No wonder docs in Canada have been spooked and are anxious to keep their heads down!

Interestingly, in 2010 in BC, when the issues of detecting and treating Lyme disease were referred by then-DM of Health John Dyble to the BC CDC’s Dr. Brian Schmidt to make an independent review, Schmidt drew the conclusion that the diagnostic instrument in use today was “unreliable”. Yes, that’s right, the test technology recommended to determine whether you get access to care and cure was “unreliable”, and especially so during the earliest phases of infection. As in, when Lyme is most easily cleared with a short course of off-the-shelf antibiotics, which is when there's time to prevent it debilitating you and ruining your life. And that is just the time when docs are prone to relying upon an untrustworthy test to rule Lyme disease out (and let's be honest, the test in use rules out a loads of Lyme disease every year, finding only a few potential cases). 

So Dr. Schmidt, a man without an axe to grind and clearly not an infectious disease type, drew the rational conclusion that this was a poor test design that had not evolved one bit in thirty years, that it needed replacement with a superior conception, and that finding a reliable diagnostic test should be, for BC and for Canada, “the first and highest priority”. One would think that such a clear recommendation, made to a DM of Health by someone beyond any controversy, would provide a basis for a Minister of Health to take corrective action – i.e. that s/he would move to caution doctors against using the test for diagnosis, remind them the disease is a clinical diagnosis, and redress any lack of knowledge of actual Lyme symptoms by arranging teaching symposia. And for good measure, s/he would also announce sponsorship for independent research to develop a reliable test. BC, by the way, would be an ideal instigator of such research, having won acclaim for developing the gold-standard AIDS test that's now used globally. But before a Minister could do anything like warn doctors about test inaccuracies, those busy little beavers who support the IDSA down at the BC CDC, and their overseers, the cabal of Infectious Disease Specialists, immediately began erecting high fences around any ideas of communicating anything. And inoculating their poor standard of care against further criticism by loudly repeating their mantra, ‘based on science’. 

Alas, those hastily made barriers remain in place to this day. Last year, when CanLyme President Jim Wilson and I wrote a newly minted Liberal Health Minister, Hon Margaret McDiarmid, herself an MD, about certain false public statements made by Drs Henry and Kendall concerning Lyme disease (for example, the claim that the current test is competent to detect all five [known] strains of borrelia – a claim for which scientific evidence is lacking, and for which there are ample explicit warnings to the contrary) we were stonewalled. No acknowledgment of the letter, no reply. Ditto the question of the mounting scientific evidence that Lyme disease is in fact a bona fide chronic illness that does respond to longer treatment (a fact our chief health officer, Dr. Kendall, has denied publicly, asserting that there’s no evidence for treatment efficacy) – again, silence. The cone of silence is just what greeted Dr. Schmidt’s report, when it was finally made public through FOI. Since then, I've never heard a CDC official, a public health bureaucrat, or an infectious disease doctor mention Schmidt - not once, not even to dispute him. Silence. This lack of response is highly problematic in a democracy, where it’s the role of the citizenry to monitor bureaucratic decision making (including public health) and challenge assumptions. It also suggests that the politicians, to this point, have been captured by the College, the infectious disease doctors, the BC CDC, and our public health bureaucrats, all of whom are now invested in a theory that’s patently false and are working overtime to cover their duffs. And that what they tell the public is not bound by the rules of scientific enquiry and evidence, but can be any old thing that comes to mind, indeed that it is now in the realm that lies between public relations and outright propaganda.

I can understand a politician’s reluctance to deal with issues of considerable complexity that involve reviewing positions taken by qualified people, because I've been one and it's not easy to be critical of people with specialist credentials. But when flawed instruments and biased practices are being used to deny Canadians access to the medically necessary care they’re entitled to (and have paid for from taxes), politicians simply have to turn their minds to the matter. It’s a kind of Tommy Douglas moment, one calling for action to right a fundamental injustice to all those denied care and cure for a bona fide illness, the medicine for which is sitting on the shelf and costs pennies. Douglas would never have accepted the withholding of care just because private professional associations and a bureaucracy refuse to revisit an ill-conceived framework. Perhaps with the advent of a new government in British Columbia in May (during Lyme disease awareness month), we will see a certain opening of the political mind – one that recognizes the pressing and urgent need to enlarge the practice space for doctors, to allow them use of their considerable training as medical detectives to learn how to diagnose and treat tick-borne infection unencumbered by faulty tests and arbitrary rules concerning treatment lengths. A little official encouragement to good doctoring would certainly go a very long way, and there is ample evidence now to support the need for such intervention! 

But if more evidence were needed that we have a severe problem with tests missing Lyme disease, then warnings quietly issued late in 2012 by Health Canada should tip the balance in favour of the precautionary principle! Here we have an agency that up until then had been a registered IDSA Kool-aid drinker, but that suddenly swore off and jumped on the wagon: to wit, stating clearly that Lyme disease test kits are (a) supplemental to clinical diagnosis and (b) “should not be the primary basis for making diagnostic and treatment decisions”, because they have “sensitivity and specificity limitations” and may result in “false negative results”. To anyone inside Lyme advocacy, the acknowledgment of the possibility of "false negatives" (ie the test being wrong) is a vindication of what they've been saying for decades.

Given that provinces like Ontario link their treatment guidelines explicitly to federal statements about Lyme disease, perhaps the repeated warnings from Canadian scientists who study tick and disease proliferation and report strain variation finally led Health Canada to revise its approach (it is to be hoped). There are of course liability issues that may have prompted change, pertaining to the rights of individuals to security of person, should it turn out that officials knew or should have known the test was unreliable and left it to decide people's fates anyway. For whatever reasons, Health Canada’s Adverse Reaction Newsletter breaks ranks by actually citing the scientific studies that substantiate the limitations of testing, putting its sensitivity as low as 38% for people with EM (bulls-eye) rash! Think of it – if you have the rash, you have Lyme, no debate about it. It’s the one and only physical symptom that IDSA guidelines acknowledge as diagnostic of Lyme. And in cases where people manifest that symptom, the test used to rule Lyme out in BC at best finds 38% of them positive! Most people with Lyme don’t ever get an EM rash, and many people who have the rash are forced to take the test and then refused treatment when it comes back negative - as it nearly always does!

Not only are false-negatives acknowledged (imagine the shock to public health officials and infectious disease specialists who deny the very possibility of false negatives – in the whacky world of mathematical medicine, there are only ever false positives, they swear by their holy algorithms!) – but Adverse Reaction actually identifies the probable causes of false negatives in testing, drawn from the scientific literature: “(a) a slow antibody response early in the course of the disease, (b) genetic diversity of B. burgdorferi and (c) treatment with antibiotics”. Dr. Kendall's belief in the magical powers of this test to capture strain variation are here clearly trumped by the warnings of Canadian scientists that genetic diversity of the organism poses the risk of inaccurate testing.

Or, note this: “the Lyme disease test kits are not designed to screen patients or to establish a clinical diagnosis”. Or this: “a negative result, especially early in the course of infection, does not exclude B. burgdorferi infection as the cause of illness”. And this: “Serologic test results should be used to support a clinical diagnosis of Lyme disease and should not be the primary basis for making diagnostic or treatment decisions.” In other words, it’s back to the future – ie. back to a clinical, differential diagnosis. But that’s the exact opposite of what goes on today in the average doctor’s office here in algorithmic BC, thanks to behind-the-scenes policing by the College and the BC CDC. Just this week I got an email about a woman in Vernon who brought the tick with her, showed her doc the spreading rash, and was instructed to throw the tick away, wait two weeks, and then get the test. The test will do the doctor's thinking, and it will almost certainly be negative, as it nearly always is....and then she’ll be absolutely free to get really ill and stand by as her life goes down the drain.

All of this underscores the pressing need for direct communication from the Minister of Health to all doctors, informing them of the limitations of current serological testing, for as Health Canada blandly but accurately puts it: “Health care professionals should be aware of the limitations of Lyme disease test kits”. Well, should be but aren't, or if they are aware they are afraid of repercussions that would follow if they acted on the awareness, so there’s work for the Minister to do on that score. Doctors need to be given guidance in a public way, one that confirms to the monitoring institutions, like the College and the CDC, that the jig is up when it comes to the unreliable test. Current public health policy has effectively narrowed the practice space (where a doctor acts like a doctor and interprets symptoms) to zero when it comes to Lyme disease. But Health Canada has provided Ministers with the rationale for communication regarding testing. And accepting the need for that communication to happen leads to a second shoe dropping, which is that the IDSA guidelines can no longer be taken as best practices – for the simple and compelling reason that they mandate medically inappropriate reliance on a flawed test to diagnose Lyme or to bar treatment.

Obviously, from a public health perspective, if things were working as they should be, our public health officials and the College of Physicians and Surgeons would have already informed doctors of these realities. But having implemented the system we have in place, they are now more concerned to protect past mistakes from being exposed or corrected than they are in countering a spreading disease. So it really has to be the politicians, and they will have to be strong enough to insist that the evidence about the test limitations be acknowledged. Perhaps a new Minister, seeing all of this with fresh eyes and the firm conviction that public healthcare exists to cure disease, might invite the public health apparatus to draft such a letter to doctors communicating the limitations of Lyme disease testing and counselling them against using it diagnostically. S/he might wish to combine this with an initiative to create new learning tools to enable doctors to learn the symptomology of Lyme disease in order to aid in their clinical diagnosis. The politicians will have to stimulate development of the new learning tools, and be involved in overseeing the wording of the communication, lest it simply morph into yet another rationalization of the status quo. I doubt the apparatus will go along willingly, but I'd certainly love to be wrong on that, and it really must be done.

Dr. Brian Schmidt (whose report along with Health Canada’s statements will be useful in explaining to public health officials why the need to communicate about test limitations) also recommended ensuring that BC doctors understood their rights to practice "alternative medicine" in British Columbia, meaning the right to practice beyond or outside practice standards set by the College or the CDC. Practicing alternative medicine means that if there's a body of evidence to support the value of a proposed therapy, a doctor has the latitude to undertake the treatment free from professional harassment. That’s just the sort of practice space we need to see created in order that the abundant Lyme infection showing up in doctors’offices can be recognized and dealt with in the acute phase, when a month of an antibiotic like doxycycline is all that’s likely required. A larger problem, which I’ll save for a separate post, is the need to enable doctors to administer longer courses of antibiotic therapy to patients with chronic Lyme disease.

To the south of us, where Lyme and other tick-borne infections have reached epidemic proportions, the politicians are in fact confronting the insurance companies and their use of the IDSA guidelines to shed responsibility to pay for antibiotics and other medications to treat chronic Lyme disease. There state politicians have passed laws to counter the private insurers predisposition to foster lawsuits and credential hearings for malpractice against doctors who provide such care. Bills have been passed in a number of states, including Connecticut where the Lyme epidemic originated, that prevent insurance companies from de-insuring patients who are being treated with antibiotics for longer periods than specified in the guidelines. Some explicitly protect doctors from having their licenses interrogated simply for treating people with antibiotics for longer than IDSA guidelines. Essentially, these laws prevent profit-driven ‘managed care’ from effecting what amounts to de facto de-insuring of an illness. We've imported an identical problem here in Canada, compounded by our being a single insurer form of healthcare, where the big entity refusing responsibility for an infectious illness is in fact our governments, federal and provincial. It's important the politicians in those governments recognize that the upshot of current guidelines is to deinsure Lyme disease for most people who get it, and that this is what has to change. The only instrument is to move to a higher standard of care, which is one that lessens the absurdly restrictive controls currently in place. The good news for cash-strapped governments is, it won't require additional funding to provide early care; rather, it will save a fortune down the line in irrelevant tests and ineffective treatments for phantom diseases that patients don't have.

There are a number of ways of coming at this, but each angle reveals the same necessity of acting to change the status quo. Recently the state of Virginia passed a novel piece of legislation aimed at enlarging the practice space of doctors. Entitled the Lyme Disease Testing Information Disclosure Act, it simply requires that any doctor subjecting a patient to the Lyme test is henceforth required to inform them in writing that the test is “problematic”, “often result[s] in false negatives and false positives”, and that if “the results are negative, does not necessarily mean you do not have Lyme disease”. It also requires they state that “if you continue to experience symptoms, you should contact your healthcare provider and inquire about the appropriateness of retesting or additional treatment.” This legal requirement to inform patients of the inaccuracy of testing is designed to force acknowledgment upon the individual doctor and to make it impossible for test results alone to determine access to treatment. It also contradicts what the IDSA guidelines in place now in BC and across Canada direct doctors to do, which is to use the test to rule Lyme disease out.

The answer to Yolanda’s question – ‘where does one turn?’ – is that we turn to the politicians to right the ship. There are signs of response today, such as Elizabeth May's federal private members bill, yet to come to the floor of Parliament for debate. And this year the month of May brings a renewed sense of optimism about a new government coming to British Columbia, one pledging to bring change for the better, one practical step at a time! I hope this commitment to change for the better extends to all those people who’ve been excluded from treatment for a treatable infectious disease that ruins lives and bankrupts families. It will help if our legislators bear in mind that all the untold suffering inflicted on people with chronic Lyme can be avoided simply by catching Lyme when it first appears, and that the cost of doing this is about a month of very cheap antibiotics. The cost to individuals and society of not catching it due to a flawed public health framework is enormous, and rises annually. The month of doxycycline is currently being withheld from infected people for no scientifically valid reasons and serves no public health purpose. It's also worth remembering that while Lyme is needlessly politicized as an illness, if you show up at the doc's office with really bad case of acne, you'll get as much antibiotic as needed to clear it up without any politics whatsoever. Why not for Lyme disease?

On Lyme in BC, it's certainly time to make a change for the better!

You can view Yolanda's speech on Lyme at: http://radaronline.com/exclusives/2013/04/yolanda-foster-lyme-disease-video/

If you have Lyme or are advocating for higher standards of care for Lyme and want to know more about the flaws in testing, here's a link to an informed discussion:  http://thetickthatbitme.com/tag/borrelia-burgdorferi/

A huge repository of information and science on Lyme, along with contact information, is available at: http://canlyme.com/

For Elizabeth May's "An Act respecting a National Lyme Disease Strategy", go to: http://parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=5696477&File=33#3

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                                                                                    www.CanLyme.com

Charitable Reg #  864437603RR0001           

Honourable Dr. Margaret MacDiarmid                                         Oct 30^th, 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

Director

  

Jim M. Wilson,

President

The Rights To Treat and Be Treated

There’s a real possibility that recent events in British Columbia signal the beginning of change in Canada’s suppressive approach to Lyme disease. So far in 2011:

• A report on chronic Lyme disease by a senior public health official found the Lyme test ‘inadequate’, acknowledged that chronic Lyme can be treated to improve quality of life, and recommended doctors be empowered to adopt ‘realistic but flexible’ approaches to treatment in consultation with their patients.
• For the first time, a provincial health minister acknowledged the presence of undiagnosed and untreated chronic Lyme disease in BC and confirmed that doctors have the right to prescribe longer courses of antibiotics than set out in the Lyme guidelines.
• BC announced a new initiative to set up a complex chronic disease clinic to gain experience treating chronic Lyme and to initiate research on a reliable Lyme test.

It’s clear that something changed in the BCgovernment’s approach in 2011. Asked pointedly in Estimates debate by MLA LanaPopham whether BC doctors have the right to prescribe antibiotics for Lyme disease beyond current guidelines, Health Minister Mike de Jong responded:

“There are no constraints on the part of a physician in the circumstances the member has described from prescribing alonger course of antibiotics. That remains the exclusive domain of the physician.”

This frank statement gives primacy to a physician’s judgment in prescribing a remedy for disease. It means that if a doctor diagnoses a patient with Lyme and believes that antibiotics should be given until symptoms resolve,s/he has that right. Unfortunately, it’s also a right not exercised by many doctors today.

In Minister de Jong’s words: “there is, admittedly, a reluctance to do so because the physicians in general terms will follow the guidelines they are presented with by the College in Canada and by international bodies.” That’s the reality in BC and across Canada, and it’s why the guidelines and messaging to docs about the threat and incidence of Lyme need desperately to change.

Most GPs feel pressed to conform to what’sapproved by their licensing body, the public health apparatus, and specialist doctors. Most won’t exercise a right to treat more comprehensively when those holding their license uniformly repeat that a one-size-fits-all formula is best. This is especially true for a disease that few have wittingly dealt with, onethey’re insistently told is ‘rare’ and unlikely to be seen.

Fact is, BC docs are actively discouragedfrom diagnosing Lyme. It’s not too much to say there’s a stigma attached to it,nor that a dim view is taken of any doctor who breaks ranks. The message is,let the test tell you the answer. Fear of being outed for treating Lyme is why Dr. Brian Schmidt, author of a high-level report on chronic Lyme disease for the DM of Health, recommended BC“satisfy itself that a doctor may prescribe therapy to a patient that departs from prevailing medical practise”; and that “a doctor will not be investigated solely on the grounds that the registrant practices complementary medicine oruses non-traditional therapies”. I take him to mean that BC should remind doctorsthey have this latitude, should they in their professional judgment determine a therapy is advantageous to patient health.

These are rights and obligations set out in BC medical law that both doctors and regulatory bodies are insufficiently aware of – especially with respect to diagnosis and treatment of chronic Lymedisease. A longer course of antibiotics for chronic Lyme departs from prevailing practise, yet would qualify as complementary or non-traditional therapy for an illness the physician believes exists.

In Dr. Schmidt’s words: “Concerns continue about the rights of physicians to provide treatment advice to their patients,and the patients’ rights to receive care. Despite the advice of regulating bodies to the contrary, many physicians are fearful of retribution”. In other words, behind the scenes in medicine, there’s a chill on prescribing practises that depart from guidelines for Lyme patients. For infected patients looking to access needed medical care, this chill combines perversely with the Infectious Diseases Society of America’s denial of a chronic form of Lyme.

Dr. Schmidt’s recommendations reflect the urgency of reminding doctors that they are to make the choices in concert with their patients, and that the CPS’s role isn’t to penalize them for supplying a higher standard of care. There is after all a body of research supporting the existence of chronic Lyme and the possibility of symptom-relief and return of function using longer-course antibiotic therapies.

Dr. Schmidt determined that scientific opinion, rather than denying a chronic form of Lyme,supports the idea that it’s a bona fide disease for which ‘no effective test currently exists’. And clinical experience (ie. what physicians have learned from repeated courses of treatment) – if allowed to weigh in the balance – shows definitively that many can return to normal function with antibiotic therapy.

Patients with chronic lyme know thedifficulties of getting such therapy in BC. Inevitably, for an infectious disease that’s bacterial, antibiotics are needed, and when chronic, certainlyfor longer than a month. Absurdly, that’s just what the IDSA guidelines aredesigned to rule out. This works very well for US private insurance companies seeking to close off reponsibility for ongoing therapy, but it deals Canadian patients right out of their care benefits.

Treatment may, for some very sick people,involve taking antibiotics intravenously (many cannot take sustained oral ingestion without reaction). This option is effectively policed out in Canada,via quiet collaboration between Infectious Disease doctors and the hospitalistswho would install the PICC lines for IV therapy. If an IDD won’t authorize theinstallation – and none in BC will so far as I know – IV therapy simply can’t happen.

The BC guidelines are all about confiningantibiotic use to the narrowest circumstance, only where a flawed test ‘finds’Lyme, and then for only the shortest period of time – sometimes as little asten days. And never more than once, whether a patient has had Lyme for a weekor for years.

Dr. Schmidt’s review of the literature concluded what every Lyme victim sadly comes to realize – the test is inadequate and cannot be relied on – yet it’s being used to rule it out definitively. No positive test result, no diagnosis, and no antibiotics – now or ever.

Reliance on a test that doesn’t work keep sick people from accessing medically needed care. Denial of treatment for chronic Lyme keeps disabled people from any relief of pain and return of function. The IDSA guidelines are also used by private insurance companies inCanada (and the infectious disease doctors working privately for them) to deny sick patients care-benefits under their extended healthcare plans (drugs, homecare and nursing, LTD).

Dr. Schmidt notes that “the current state of diagnostic methods for Chronic Lyme and other related infections is inadequate”. He recommends “urgent attention” be given to creating betterdiagnostics and that testing for co-infections become “a component of thestandard diagnostic panel”. Improving diagnostics “is the first and highest priority for BC”.

Compare this to the BC CDC’s Dr. Henry,whose faith abides in the two-tiered test regime – despite strong evidence to the contrary; and in the ability of BC doctors’ to diagnose Lyme – despite 63%of them not recognizing the sole physical symptom (a bulls-eye rash) theguidelines allow as diagnostic.

This I believe is why Dr. Schmidt warned againstthe ‘risk of complacency’: passive surveillance of the population based on confidence in a test whose poor design is fixed like an insect in amber means no clear picture of the actual number of Lyme cases. And refusal to treat those with chronic Lyme means a sentence in hell and/or personal bankruptcy for manyinnocent people.

Just as Schmidt’s confidential report was being released by Lyme advocate Gwen Barlee, BC announced a significant newinitiative: a $2-million specialty clinic to develop experience in diagnosing and treating chronic forms of resistant illness, including Lyme disease. The new clinic is also to have a research component aimed at contributing to development of new diagnostic technologies.

Back to Minister de Jong: “We are obviouslydealing with an area where there are some differing views among clinicians…I and the government and the ministry are satisfied that there are people whose Lyme disease was not diagnosed or treated, and they went on to have real longer term chronic complications.”

This is a giant step forward for government and the ministry of health, placing them beyond the ruling orthodoxy. Minister de Jong acknowledges that Lyme is sometimes missed in BC, goes on to become chronic, and that this has consequences for the lives of patients. These peoplehave been mostly abandoned to their own devices to this point. The new clinicis intended to create a base of experience that might begin to remedy that situation by contributing to new standards of care.

Sustained denial of all problems with Lyme policy has been government’s typical reaction, so this marks a major turning point. The new position is consistent with Schmidt’s reading of the scientific literature, which found the test unreliable but affirmed the efficacy of antibiotic and anti-microbial strategies in treating chronic Lyme – a disease that places “a significant burden on patients who are sometimes given few options or hope.”

“In the face of existing diagnostic knowledge, which is ambiguous at best, it is understandable that a significant proportion of the medical profession is hesitant to move away from the strong and appropriate tradition of only practicing within established standards of care. Hopefully, standards of care and better diagnostics will change with more evidence, but in the face of no treatment at all patients are in the middle of the issue.”

The current ‘standard of care’ results in most physicians providing no treatment at all for chronic Lyme. Enter the clinic: “The good news is that the government recognizes that….we’re probably in a position where we want to get some reliable information and data of our own, which is why the $2-million has beenallocated to fund the diagnosis study.”

It’s fair to infer from this that the clinic is intended to create a space wheretreatment experience can accumulate and be documented and openly discussed. By extension, it implies the high fence the IDSA has built to isolate chronic Lyme from obligations to treat may now have an escape hatch. It will be necessary to ensure no IDSA ideologues invade the treatment space, if learning is actually to occur.

Minister de Jong refers to the “uncertaintyor debate about what… best practises on the diagnostic side actually are”. The$2-million clinic-study is intended to “add to the body of evidence that will help resolve that”. “…until those best practises change, we’re unlikely to seethe response from medical practioners change”.

It’s still early days for the BC Lyme clinic. Negotiations are under way with a potential host and there’s work being done on a clinical delivery model. Therehave been initial discussions with CanLyme about how the clinic might work and on the technical matter of a working definition of chronic Lyme. An advisory group with advocates included is part of the design, but hasn’t been convened. We’re still a long way fromanyone with chronic Lyme actually getting treated. But in the design phase at least, the door appears open to more patient-focused model of care.

Research is to be a second thrust for the clinic: CanLyme is encouraging work towards a reliable test that will bring the kind of ‘certainty’ that enables clear identification and prompt treatment. The potential involvement of Genome BC in the initiative is intriguing. B.C. has donestellar work in developing an HIV test that is now used worldwide – perhaps a reliable test for Lyme could emerge from this collaboration.

All of this is good as far as it goes. But the IDSA guidelines remain in place and doctors, most of whom are kept Lyme-ignorant by design, will continue to rely on ELISA results to rule Lyme out definitively. This means that an unknown but growing number of British Columbians will be condemned each year to develop a life-ruining illness for which they’re unlikely to receive any treatment (unless they self-diagnose without-of-country testing and can somehow find their way into the new clinic).

As advocates, we obviously can’t put all our eggs in the clinic basket. Enough is already known about Lyme to detect it clinically and treat it pre-emptively. It’s not hard to get Lyme, but it can be easy to cure if the intervention follows soon after the bite. Schmidt put the Lyme test’s accuracy in the first five weeks of infection at as low as 20% -that’s the window in which you can treat it most easily and avoid dissemination.Many would put the test’s efficacy far lower still.

With appropriate signals from the Minister of Health and the College, more doctors would feel confident in using their judgment to detect new Lyme infection. The cost of treating it with a month of antibioticsas early as possible is negligible. Think of all the suffering (and expense) that would be spared if the system erred on the side of treating early, rather than on the side of delaying and denying it.

While developing our own treatment experience here is vital, there’s vast experience in treating chronic Lyme in the USA. It would be an excellent idea to find ways to transfer some of the strategicknowledge of doctors like Sam Donta and Raphael Stricker to BC, in order to accelerate our learning.

Dr. Schmidt characterizes Lyme as a stealth pathogen that takes multiple forms and is resistant to extirpation. He refers to the huge potential to aim therapy more strategically at the hiding forms borrelia assumes when it’s chronic. Doctors with broad treatment experience may have useful ideas about how to do that, and how best to deal with the complications of co-infections like Babesia. Conveningopen symposia on pattern recognition and treatment modalities would beconsistent with his recommendation for “more professional education on atypical symptoms and presentations related to B.b. and related coinfections”.

Minister de Jong’s responses to MLA Popham’s questions were encouraging to hear. It’s a giant step beyond his predecessor’s one liner that ‘ BC treats Lyme to international standards’. The fly in theointment is the Minister’s belief that the BC CDC has renewed efforts to raise awareness among B.C. doctors. While he sees this as a sign that Lyme detection is improving, these efforts unfortunately are firmly rooted in reinforcing the status quo. The CDC’s communications with doctors,such as they are, aim to pull them back into the IDSA straightjacket, and into continuing reliance on theflawed test regime to rule Lyme out.

BC has over 5,000 doctors that need to hear that most of BC is endemic for Lyme disease and that people can be exposed to infected ticks in their backyard orin the local park. They need to be educated to recognize variable symptom patterns and warned not to rely on the test. Lyme disease in BC is overwhelmingly neurological, not arthritic. Coinfections are becoming the norm. There should be a clear message to doctors that a negative ELISA should never be used to rule out Lyme disease.

Certainly no one with a bulls-eye rash should ever be told it’s just a ‘spider bite’ or that ‘we don’t have Lyme in BC’. These last two responses – both frequently heard – represent deep ignorance rather than medical insight. They instantly create new Lyme victims and deal sick people out of care-benefits they’re entitled to. They would be immediately addressed if public health were actually seized of its mission to protect the public’s health.

I think many doctors would benefit just from seeing the Minister’s statement that they retain the right to prescribe according to their professional medical judgement. Some know it already, butmost have been captured by the group think that is the IDSA guidelines. I think they would also benefit from seeing Schmidt’s conclusion that ‘antibiotics are inexpensive and generally considered safe…if carefully chosen, delivered, and medically overseen.”

Access to IV antibiotics, which may be necessary for some patients with complex infections that are chronic, is another matter. Currently infectious disease doctors are mobilized to refusesuch therapy for tick-borne infections – somehow this monopoly has to be broken up, as the refusal to recognize chronic Lyme and the blanket prohibition on IV therapy stands between sick people and their health.

Doctors have rights to treat infectious disease with antibiotics, and patients have public health rights to receive medically necessary care as needed. Current circumstances conspire to removeboth sets of rights using rigid formulas where more open approaches are required. We need to keep the Schmidt report in front of the government, the public, and especially our corps of doctors.

That said, we also need to hope we don’t lose Minister de Jong to a cabinet shuffle, and that he continues to move along the Lyme disease learning curve. Openness to change is very welcome. And long overdue.

To read the Schmidt report, go to:
https://docs.google.com/viewer?a=v&pid=explorer&chrome=true&srcid=0B4gw9r5fhMl8ZGM3OWJiYTctOTc1Ni00MzQ1LWI2NWEtM2Y5MDJhZDFiYTI0&hl=en

Visiting Canada’s Lyme-leper Colony in San Francisco

Recently I visited with family members living in San Francisco for treatment of a son’s chronic Lyme disease. Refused diagnosis in Alberta, their son Riley got so ill that he and his mother had to move to the US to try to get his health back. A desperate measure, but when the door slams shut on therapy in Canada, there’s only one choice left.

As it turns out, my relatives had joined western Canada’s growing Lyme-leper colony in California. No one in public health up here bothers to notice how big this exodus is – when it comes to Lyme, they prefer to let sick dogs lie. But in San Francisco I learned there’s a whole clutch of Calgary families there buying their Lyme-care. And we can be sure there are Edmontonians and Vancouverites too, because Canada’s refusal to treat people infected with Lyme disease is as universal as our healthcare system.

Young Riley is one very sick boy, having picked up three nasty infections from a single tick bite. This is increasingly the case in Canada, but it wasn’t detected at home – Alberta relies on a faulty Lyme test and doesn’t check for co-infections. We could, of course, decide to improve our shoddy testing, and help our doctors learn to diagnose Lyme from symptoms, but that would require a clear commitment to combat tick-borne infection. Right now, that’s not a public health goal anywhere in Canada.

As a result of Alberta Health’s failure, Riley is now immobilized in a far-away bedroom in San Francisco, where light, movement and sound can be closely controlled. Lyme invades the brain and disrupts the limbic system, making external stimuli painful and disorienting for patients. So Riley is sequestered from people and sound much of the time.

This is a bedroom where he’s tended lovingly by his nurse-mother Christine, for long hours every day. A bedroom he only ever leaves laboriously and briefly, occasionally in a wheelchair for visits to his doctor. A bedroom that’s really now his entire world, in a relative’s house, where family and friends visit in order to help keep hope alive.

Riley was brought to California to be close to his Lyme-literate MD because he’s far too sick to commute from Alberta for appointments. He also needs constant monitoring for his reactions to medications. There are no LLMDs anyone’s aware of in Calgary, nor would one, if s/he actually existed, be allowed to treat chronic Lyme disease in the ongoing, exploratory ways needed.

Riley has a PICC line in his chest to receive the IV antibiotics, antimicrobials, and supplements he needs to clear infections. His digestion is highly disrupted, so he takes his food in liquid form, as smoothies that Christine makes and feeds him, slowly, using a Dixie cup. The medications make him very ill with serious Herx reactions (mass die-off of bugs). Obviously it would be far better if Riley could get his care in Alberta, from local docs, under public health insurance.

Typically, a Canadian doctor known to treat any amount of Lyme disease in any province attracts the unwanted attentions of the local College of Physicians and Surgeons. It shouldn’t, of course, but the behind-the-scenes threat is loss of license. Prescribing open-ended antibiotic therapy would also bring down a posse of Infectious Disease Specialists, whose true specialty seems to be blanket refusal of antibiotics for tick-borne infection (‘self-limiting diseases’ in their 1984-speak).

Like every Canadian Lyme-victim, Riley has an abstract ‘right’ to receive ‘medically necessary care’ for a treatable illness – he’s an insured member of our mandatory healthcare plan. But Canada and the provinces have adopted American ‘practice guidelines’ that effectively de-insure Lyme disease, completely trumping that right. Mandatory inclusion turns into total exclusion from benefits.

Riley did eventually get tested for Lyme in Alberta, and of course he was negative (isn’t everyone!). And under the U.S. private-insurance-company standards that rule Lyme diagnosis in Canada, that test result ‘proves’ he doesn’t have Lyme. It’s bizarre that a test with at best ‘coin-toss diagnostic utility’, that likely misses over nine in ten cases of Lyme, would be relied on to deny it definitively!

Yet Riley did in fact have Lyme and eventually got the serology to show it. But it was delayed a long time, because doctors were disinclined to test him at home, believing firmly that ‘there’s no Lyme disease in Alberta’. As none of these doctors had any clinical knowledge of Lyme, in the end one defaulted to the flawed test to rule it out. And by the time Alberta Health got around to doing this, the bugs had become chronic and colonized much of his body.


More reliable testing, purchased later in the USA, showed him to be positive for Lyme, as well as having Bartonella and Babesia. In other words, ‘better diagnostics’ revealed an all-out assault on Riley’s immune system that was carelessly missed, and glibly dismissed, at home. Another Canadian patient with multiple infections doomed to endure a wasting disease due to complacency in public healthcare.

Note that across Canada, if your step-one ELISA test reads negative, you don’t have Lyme, period. Ergo, you must have something else. Often it turns out to be something fuzzy and untreatable, like an ‘idiopathic’ eating disorder (which ‘explained’ Riley’s thirty pound weight loss); but just as likely, the doctor who says ‘we don’t have Lyme in Alberta’ decides quite arbitrarily that the problem is really in the patient’s head!

It’s funny how so many formerly healthy people, who one day mysteriously begin deteriorating and have the clear feeling that something’s running amok inside, are quickly deemed hypochondriacs by doctors unqualified to make such a diagnosis. And it’s perverse that a lousy screening test allows them to slam the door on more constructive explanations.

Dr. James Schaller, a specialist in tick-borne infections, says of this test: “if your clinician wants to first use an ELISA, simply run! To put it bluntly, the ELISA test as a screening tool is useless…” He continues: “many labs use inferior test kits that are so poor that they miss patients who present with obvious bulls-eye rashes and clear Lyme symptoms.” He’s speaking about the USA, but Canada relies on the same flawed test to definitively rule out Lyme disease – and we’re very good at ruling it out!

Even with clear evidence of Lyme from an Igenex ‘best-practice’ Western Blot, people like Riley are denied all treatment in Canada. Just like private U.S. insurance companies, our governments refuse to provide any therapies for chronic Lyme disease. They just withhold antibiotics and leave you to rot.

Indeed, public health officials line up squarely behind the Infectious Diseases Society of America in denying there’s any such thing as chronic Lyme disease (an irrational idea without scientific evidence). So Riley’s family, like hundreds every year, learned the hard way that Lyme disease is Canada’s first fully privatized illness. And like lots of other western Canadian families, they faced the wrenching choice of travelling (in their case moving) to San Francisco – where they may not leave their hearts, but will definitely leave bags of their cash.

One day I watched nurse-Christine order drugs and supplements following a visit to Riley’s naturopathic doctor, and carefully create a written schedule for his daily IV drips. This process took over a day to complete, with goods arriving in boxes via courier the next day. She’d done a lot of comparison shopping to try to keep prices down. Still the cost, for what would partially cover a couple of weeks at best, was way over a thousand dollars! That’s fiscal reality in Lyme-leper land.

San Francisco attracts Canada’s Lyme-lepers because it’s home to some of the most Lyme-literate physicians in America. Since there’s no local knowledge available in Canada (that is, clinical experience with Lyme sufficient to discern its patterns) and since access to antibiotics for chronic infection is taboo, you’re forced to choose: either go where there’s clinical skill and access to antibiotics, or just watch your loved one deteriorate painfully, and possibly even die.

I’ve noted the tragic irony of this before: Canadian families who revere our healthcare system are forced to uproot, go to a foreign country and buy ‘medically necessary’ care. All this because Canada has adopted American ‘practice guidelines’ that ‘manage care’ by shedding responsibility for as many sick insurees as possible. The guidelines do this by means of manipulated disease definitions.

If this sounds diabolical – well, there are elements of that about it. The algorithm (or formula) that determines whether a Canadian test detects Lyme or not is loaded against showing it (mis-primed, thresholds set too high, etc). So is the algorithm rigidly restricting antibiotic therapy to a short course for the few cases ‘proven’ by the faulty two-stage test (about 150 in all of tick-ridden Canada).

Algorithmic medical care is machine-medicine at its worst. It trumps the clinician’s and the patient’s roles in detecting and diagnosing disease, and together deciding the best course of therapy. It denies the patient the knowledge that there exist two distinct sets of medical guidelines for Lyme and co-infections – one relying on the faulty test that nearly never finds it, another based on clinical diagnosis from symptoms and ongoing treatment. It arbitrarily replaces complexity with unwarranted certainties.

Riley had 42 symptoms of Lyme disease listed by the second set of practice guidelines – but these symptoms aren’t accepted for diagnosis in our monolithic healthcare system. None of his 19 Alberta doctors recognized them! There’s just one diagnostic symptom allowed under IDSA guidelines, and most people never have it. So it’s too bad, so sad – now get lost!

This needless, inhumane denial of diagnosis and treatment in Canada victimizes families at every level. Those with resources to liquidate are ‘free’ to bankrupt themselves buying care state-side; those without are ‘free’ to suffer in silence and lose their quality of life and independence.

Riley’s illness was allowed to run rampant due to Alberta’s complacency and the failure to get a couple of hundred bucks worth of antibiotics into him pronto. Now he needs tens if not hundreds of thousands of dollars worth of them suffusing his pain-wracked body indefinitely. And with uncertain outcomes!

Cost of care, ballpark, in San Francisco, with the LLMD, naturopath, rolling tests, antibiotics, pro-biotics, homecare nurse for IV cleansing, and assorted therapies, could be as much as $100,000 a year. Easily that much if we allow for lost income for the nurse-mother, or place a value on her 18-hour days. Then there’s rent in San Francisco for most people, often living alone in some grubby flat.

During my stay, I boned up on Lyme when I wasn’t chatting with Christine about the formidable challenges of nursing her boy back to health. I read essays on different approaches to treatment by doctors of varying backgrounds, full of insight into ways of defeating a cunning pathogen and its many manifestations. Pattern recognition is vital in treating complex illnesses, and it only comes from clinical experience. I was impressed by the breadth of experience of doctors who do treat chronic Lyme disease, and aghast that we’re doing nothing to transfer their knowledge into our Canadian medical toolbox.

Riley’s Lyme disease is strongly neurological, and he has co-infections, which requires different approaches than if he had arthritic Lyme and no co-infections. His is also chronic, meaning it was allowed to disseminate. Early on, when the Lyme spirochetes are mainly in the blood, they’re much more treatable than when they spread to organs and remote tissues. They then take persistent forms that evade detection and are more resistant to antibiotics.

Everything in the literature emphasizes the complexity of dealing with chronic forms of Lyme; all evidence reinforces how vital it is that we catch Lyme and the co-infections early and hit them hard with antibiotics. This is pre-emptive public health policy that would cost peanuts to enact but would reduce suffering and debility immensely. Greedy insurers may not wish to do this, but there’s no such motive in a public health plan where risk is pooled and early intervention is the mantra.

Poor Riley got a triple whammy, getting undetected Bartonella and Babesia as well as Lyme. Dr. Schaller calls Babesia Lyme’s ‘cruel cousin’. Increasingly they travel together in ticks, yet Babesia is completely neglected in Canada. Schaller describes their evil synergy: “Lyme weakens your immune system and makes it less capable of controlling Babesia. Interestingly, Babesia infection helps make Lyme disease stronger.”

‘Interesting’ is too neutral a term for the agonies inflicted by these terrifying diseases. The cost in individual lives of missing the opportunity to pounce when they first occur is incalculable. Canada’s indifference in light of the mounting evidence before government is inexplicable and outrageous. It completely violates the spirit and intent of the Canada Health Act’s commitment to all Canadians. And it violates a Charter right to security of person.

Recently, Lyme-activist Gwen Barlee released a confidential report by Dr. Brian Schmidt of the BC Provincial Health Services Authority. To his credit, Dr. Schmidt acknowledged that patients are being abandoned by practice guidelines that rely on poor testing and arbitrarily limit treatment to a short course of antibiotics. Even if an absolute cure for chronic Lyme is elusive, resolution of symptoms and return to an active, independent life is achievable for most.

Dr. Schmidt’s report outlines a positive direction for Lyme disease diagnosis and treatment that would re-open the door to medically necessary care for infected British Columbians. Prior to travelling to California, I’d begun urging our Liberal government and NDP opposition to move forward on these progressive recommendations. The opposition appears open to these changes, which is very encouraging. We’re still waiting for word from government.

I reread Dr. Schmidt’s report carefully while with the Lyme-lepers in San Francisco. It offers hope for a return to an ethical compass in public health policy on tick-borne infections. It provides a direction for addressing and preventing an untold amount of human suffering. Being with Riley and his mom, seeing their struggle firsthand, resolved me more than ever to agitate against a status quo that de-insures Lyme disease and denies ‘medically necessary care’ to people with tick-borne infections.

I’ll have more to say about Dr. Schmidt’s recommendations in future posts, as they deserve a much fuller public airing than they’ve had to date. In the meantime, consider this reality: every day Lyme diagnoses are missed all across Canada, generating new victims who’ll ultimately be forced to seek treatment in a foreign country and pay out- of-pocket. Some of them will become so sick they’ll have to go and live there. Many simply won’t be able to afford that choice.

So long as the status quo prevails, there’ll be a steady flow of new recruits to the Lyme-leper colony – but this is a journey no publicly insured Canadian should ever have to make! Your taxes pay for medical care without regard for your ability to pay, whenever you need it and for as long as you need it. We’re all denied access to that care if we happen to contract tick-borne infection. We shouldn’t wait to get Lyme before coming to grips with that grim reality. We should Act Now to bring public health back to its mission of preventing and treating disease.

There are many good reasons to visit San Francisco. Lyme disease should never be one of them.

For more on Riley’s story, go to:
http://rileylymebegone.blogspot.com/p/our-journey-in-last-year.html

To read the Schmidt report, go to:
https://docs.google.com/viewer?a=v&pid=explorer&chrome=true&srcid=0B4gw9r5fhMl8ZGM3OWJiYTctOTc1Ni00MzQ1LWI2NWEtM2Y5MDJhZDFiYTI0&hl=en

For an informative article about Lyme and a Canadian doctor’s struggle to have it addressed in Canada: http://www.citylifemagazine.ca/health/lyme-disease-tick-talk/5717