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