Canada: Serious flaws in a medical system lacking medical and scientific ethic

Presenting at a Lyme disease conference held in Bridgewater, NS, in November 2019, it was said that Nova Scotia lacks proper protocols when dealing with the ignored epidemic of Lyme and tick-borne diseases [TBD’s]. We have the highest incidence in Canada conservatively estimated as 454/ 100,000 across the province to as high as 1,826/100,000 in the western zone. These estimates are on the low side because Dr. Hatchette likely only included confirmed and not probable cases in 2018. [1,2] Ten to twenty percent of these patients will remain ill, suffering worsening health problems, drop out of school or the workforce and risk losing their homes and lives. [3,4] There is an escalating burden year after year. [5,6] Suicide is not an infrequent consequence of institutionalized denial and neglect. [7] Lyme can kill outright but seldom does. As the girl in the award winning documentary “Under Our Skin” says, “you don’t die, you just wish you were dead”. [8]

Current best practices aren’t best practices. Current antimicrobials are ineffective for eradicating all forms of the Borrelia spirochete. [4,9] We see the main problem as a failure of the government to enact any meaningful guidelines.

Patients have been denied access to diagnostic technologies that meet state, national and/or international standards and treatment options from guidelines that meet internationally validated evidence-based criteria.

Canadians have made it very clear that we want our own made-in Canada Lyme disease guidelines and that the status quo is harmful. Dr. Hawkins pointed out that Lyme disease lacks a standard of care statement. The “medical standard of care” is typically defined as the level and type of care that a reasonably competent and skilled health care professional, with a similar background and in the same medical community, would have provided under the circumstances.

The insurance industry has long understood that if they can control practice guidelines they can control medicine.

Lacking a standard of care, the Canadian Royal College of Physicians and Surgeons, entrenched bureaucracies, insurance companies, lawyers, and our elected representatives started viewing medical guidelines as being the standard of care – which clearly they are not. This abuse of medical guidelines has given them the unwarranted appearance of the force of law.

There are deep divides in the medical community on the nature of Lyme disease. There are 3 sets of guidelines available for treating Lyme disease all based on results from 4 small studies but interpreted differently. Only the Infectious Diseases Society of America [IDSA] and European NICE Guidelines are mentioned in Nova Scotia. There is no mention of the 2014 International Lyme and Associated Diseases [ILADS] guidelines in the Nova Scotia government statements on Lyme.

The only guidelines in North America that meet the United States Institute of Medicine GRADE level requirements are the guidelines produced by ILADS. [10,11] Nova Scotia should not accept anything less. The Centers for Disease Control [CDC] is not in charge of guidelines, the Institute of Medicine [now National Academy of Medicine] is.

The following statement on Guidance for Primary Care and Emergency Medicine Providers in the Management of Lyme Disease in Nova Scotia, [IDEG May 2019] should not be posted and endorsed on a government document when competing guidelines are available. [12] “The Infectious Disease Expert Group [IDEG] endorses the 2006 IDSA Guidelines for the prevention and management of Lyme disease” IDEG Recommends: “Lyme disease should be treated in accordance with the IDSA guidelines which were ratified by the IDSA Lyme disease guideline review panel.” Notice that they have approved their own 2006 guidelines. No patients or treating physicians were included on the IDSA Lyme guidelines panel. The Government should not be picking sides on such a contested issue and endorsing and promoting IDSA [a private organization] guidelines. Nova Scotians need independent analysis of the guidelines that are being imposed on us.

There is more to evidenced-based peer reviewed guidelines than sitting around with your buddies over a case of beer on a Friday night and agreeing how things work. [13,14,15,16]

The 2006 guidelines had grown stale and were removed form the Centers for Disease Control [CDC] website in December 2015. Why are Nova Scotia physicians being urged to use the out-of-date 2006 guidelines?

The latest draft version is even more restrictive and has been rejected by 89 Lyme groups in 12 countries. Again there was no meaningful patient involvement on the panel and none of the physicians that treat persistent Lyme cases was represented. [17]

The members of the IDEG are also members of the lobby group and private organization, the Association of Medical Microbiologists and Infectious Disease [AMMI] Canada. AMMI is a lobby group and they take their direction and owe their loyalty to the IDSA, an 11,000 member private organization that was given control of Lyme disease and all the procedures around it by the CDC, a quasi-governmental organization.

  • The Role of the CDC Plays in the Lyme Pandemic

On October 24, 2017, the United Nations [UN] Special Rapporteur [SR] on the right to health, Dainius Pūras, presented his report on corruption to the UN General Assembly. He told his audience, “In many countries, health is among the most corrupt sectors; this has significant implications for equality and non-discrimination “… He noted some are related to the global pharmaceutical industry and others from “institutional corruption” and emphasized the “normalization” of corruption in healthcare which includes practices undermining medical ethics, social justice, transparency and effective healthcare provision, as well as illegal acts. Many researchers and scholars support the SR’s findings.

[18]

Physicians and the public hold the CDC in high regard and expect impartial unbiased leadership, but this may have to be reassessed. The CDC accepts funding from industry lobby groups, which raises some serious conflict-of–interest concerns. Marcia Angell, former editor-in-chief of the New England Journal of Medicine, told The BMJ “The CDC has enormous credibility with physicians, in no small part because the agency is generally thought to be free of industry bias. Financial dealings with biopharmaceutical companies threaten that reputation.”

According to the BMJ article by Jeanne Lenzer published in May 2015: “The CDC does receive millions of dollars in industry gifts and funding, both directly and indirectly, and several recent CDC actions and recommendations have raised questions about the science it cites, the clinical guidelines it promotes, and the money it is taking.” Allowing corporations, institutions and medical organizations to help fund the CDC Foundation could in large part have led to the current problems with Lyme management in North America and globally, including its diagnosis and treatment. [19]

  • The International Diseases Society of America [IDSA]

The Public Health Agency of Canada [PHAC] collaborates closely with the CDC and defers to CDC policies and management practices with regard to Lyme disease and tick-borne disease [TBD’s]. The CDC strongly supports the IDSA organization and their Lyme guidelines and routinely rejects or ignores all evidence that doesn’t agree with dogma. A small cabal makes all decisions on the Lyme file without transparency behind closed doors. Medicine is a self-regulating profession and that privilege comes with the responsibility that they act altruistically. When it comes to Lyme our elected representatives have learned to look the other way.

A number of the IDSA members are employed by or closely tied with the CDC. By extension, the IDSA are given the preferential authority to set guidelines and policy on all matters of Lyme and TBD’s to the exclusion of any other medical groups. Most, if not all AMMI Canada members are also members of the IDSA. As such, the loyalties of the AMMI lay with the IDSA from which it takes its direction. AMMI continues to control the diagnostics and treatment of Lyme disease in Canada while categorizing any patients or experts who question them as pseudo-scientists. 

The IDSA and AMMI use the same tactics employed by the tobacco and fossil fuel industries to spread its disinformation through a front organization, the American Lyme Disease Foundation [ALDF].

In 2006 The Attorney General of Connecticut, [now senator], Richard Blumenthal charged the IDSA with abuse of monopoly power and exclusion of other points of view. The guidelines authors were key opinion leaders who also held extensive commercial interests in Lyme-related projects and ventures and had too much to gain by maintaining the status quo. He found the conflicts of the IDSA authors to be profound: They consulted with ‘big pharma’ and owned Lyme related patents; they received fees as expert witnesses in medical-malpractice, civil and criminal cases related to Lyme and they were paid by insurance companies to field-and help reject-Lyme related claims. Of the fourteen authors, nine received money from vaccine manufacturers and four were funded to create test kits, products that would reap profit if the definition of Lyme disease remained essentially unchanged. [Pamela Weintraub, “Cure Unknown” 2013, p357, italics added]

The IDSA settled the antitrust [anti-competitive in Canada] investigation by agreeing to review its guidelines in a public hearing. The panel released its findings in 2010. The panel for the hearing was exclusively IDSA members so it is no surprise that they endorsed their own society’s guidelines. Nevertheless,

the IDSA advised the National Guidelines Clearinghouse that the IDSA had reviewed its guidelines and no change was necessary. [Lorraine Johnson, Lymedisease.org 2016-02-12 Italics added]

Currently there is an ongoing court case in Texas brought by 24 sick and disabled Lyme patients claiming that a cadre of doctors conspired for two decades to deny them care. The suit charges six doctors and eight insurers with violating a law normally applied to organized crime. The defendants are the six physicians, who variously wrote the IDSA’s Lyme guidelines or helped assure they were enforced. [19]

-IDSA’s 30-Year Fixation on the Acute Stage of Lyme

The IDSA 30-year fixation on the acute stage of Lyme [the rash] after early treatment conveniently avoids the late stage manifestations of Lyme, which are crippling to the patient and unresponsive to short-term antibiotic treatment. [20] We are dealing with a serious life-threatening/ life-altering, multi-staged, multi-system infection misclassified as a simple nuisance disease with consequences that belong to the same health threat category as HIV/ AIDS, Zika, cancer etc. The IDSA, PHAC and AMMI Canada’s inaccurate conceptualization of disease has influenced the nation’s perceptions and response to Lyme. Post-treatment Lyme disease [PTLD] syndrome is simply a fabricated medical condition disguising treatment failure. [3,21,22]

There is no proof of cure. Dr. Brian Fallon who runs the Columbia University Lyme Center says that the term “post-treatment” is misleading because it implies effective treatment was given when in fact it was not, because it was too short in duration, dosage, or the wrong antibiotic or antibiotic combination for that person. Dr. Jack Lambert says PTLD should stand for partially treated Lyme disease.

ILADS members recently wrote a peer-reviewed paper on the evidenced based definition of chronic Lyme disease that should dispel the PLTD notion entirely. The evidence for persistence is overwhelming and we are developing a better understanding of the many sophisticated strategies this shape shifting stealth pathogen has to evade, dampen and modulate our immune system and resist attack from antimicrobials by forming biofilm or plaque that, by itself is 1,000 times more resistant, plus producing drug tolerant persister cells. [9,22,23]

  • The Role of Clinical Practice Guidelines

Clinical practice guidelines exist to assist physicians and serve patients and not unduly restrict clinical judgment. They are recommendations and clinical tools that should support, not subvert clinical judgment. They must be patient-centred, as patients are the end users; they are not mandates to be used by Royal Colleges to punish those that don’t conform. [24]

The 2006 IDSA Lyme disease guidelines [and the present 2019 draft] do not have a legitimate purpose and were used by the Institute of Medicine [now NAM] as a poster child of what not to do. They (1) excluded divergent viewpoints, 2) handpicked their evidence, 3) didn’t screen for conflicts, and 4) held up copycat guidelines [by the American Academy of Neurology] as independent when they were not, 5) demonstrated over-reliance on expert opinion. [13,14,15,16]

The IDSA Lyme guidelines purpose is to harm physicians who didn’t follow the guidelines and to restrict treatment to 14 days using a single bacteriostatic agent no matter what the stage of the disease.

In 1994 the insurance industry red-flagged Lyme as being too expensive to treat and made a concerted effort to deny coverage for the disease. They enlisted the help of doctors who were researching, not treating, Lyme, paid them large fees and together developed arbitrary guidelines for testing the disease. Once these arbitrary guidelines were decided, the insurers denied coverage for patients if they did not meet their new stringent Lyme disease testing protocols. [13]

These physicians agreed to change the disease description so Lyme became only a minor nuisance disease, easy to diagnose and treat. They have since served as expert paid witnesses to decline treatment and health benefits to patients claiming to be suffering from persistent Lyme disease. [13]

The disease is defined so narrowly and the bar set so high that few can pass. Sick patients don’t care about textbook pure definitions and can’t wait for tomorrow’s research.

Because the IDSA guidelines do not provide for treatment options or the exercise of clinical judgment by physicians and fail to acknowledge the existence of divergent treatment approaches, the Canadian Royal College of Physicians and Surgeons, medical societies, government agencies, courts and insurance companies may view them as a mandatory standard of care. [17]

Insurance defendants use the Guidelines as a predatory device to injure doctors who do not follow the guidelines. The 2006 IDSA Guidelines also prevent doctors from providing patients with proven treatment options because the IDSA Guidelines are extremely restrictive and they also limit patients’ ability to obtain health care and eliminate patients’ choice of medical treatment in the Lyme treatment market. [17] Royal Colleges in Canada routinely penalize doctors by investigating them if they fail to follow the IDSA guidelines, which can be costly to the patients that need the disfavoured protocol.

The latest Draft IDSA Guidelines are even more restrictive limiting treatment to 14 days with no repeats. 89 groups in 12 countries have condemned them, as once again there was no meaningful patient/ stakeholder involvement. [17] They do not meet the current criteria for trustworthiness and should be removed in favour of the more patient centred ILADS guidelines that are listed at the bottom of the PHAC web site. [25]

Family doctor’s ignorance is frequently mixed with reasonable fear: treating Lyme patients in Canada, especially advanced cases with persistent Lyme, may cost a doctor his or her license. [26] The provincial Colleges of Physicians and Surgeons can enforce this national policy of Lyme denial by investigating anybody that doesn’t conform to protocols and to the rigid IDSA guidelines even though the guidelines themselves say they are not mandatory and our courts have agreed that they are voluntary. [27,28,29] It is always of help to have a well informed patient.

IDSA/ AMMI claim that their guidelines are evidenced based but we have to point out that you just can’t cherry-pick the bits you want while disregarding everything else. It is important for people to realize that when they hear medical or public health professionals proclaim that the medical guidelines dictating the practice of medicine and insurance reimbursement for Lyme disease are based on the best available science; such assertions are rhetorical hyperbole and little else.

The IDSA/AMMI has regularly shown it ignores scientific evidence and distorts interpretations of research findings on one hand, while giving far too much credence to poorly designed low-level studies in order to justify its position on the other. Throughout medical history, new effective ideas and treatments are at first denied then ridiculed and finally accepted as self-evident. The fact is that denying, downplaying and trivializing Lyme has happened from the earliest days when we first became aware of its presence in Canada and when it became endemic in the 1980’s and evidence is being spun to fit an agenda.

Who gets to say what is evidence anyway? If it is only their opinion than they shouldn’t be calling it evidence.

IDSA guidelines do not define the legal standard of care and are not rules. They are meant to be coloured by the physician’s interpretations of the patient’s individual circumstances. The Canadian courts have agreed with this interpretation. “The courts have always made it clear that a doctor need not follow the procedures adopted by a unanimous majority of doctors. If a doctor follows a procedure adopted by a reputable minority of practitioners, it will suffice to disprove any inference of negligence.” [28,29]

Patients and their health care providers should be given treatment choices when they are available. The IDSA guidelines have nothing useful to say about the reality of the disease and the actual experience of those that have it.

The IDSA Guidelines come with an overlooked caveat: “It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. The Infectious Diseases Society of America considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient’s individual circumstances.” [27]

The defining characteristic of corruption in modern medicine is the abandonment of the patient’s interest. Patients are often road-kill on the highway to profit.

This is a medical system divided against itself. Adherents to the dominant medical opinion are willing for various ideological reasons to let people perish. We may never know how many Alzheimer’s, ALS, MS or Parkinson’s deaths might really have had a preventable bacterial origin. It simply doesn’t seem fair.

ILADS Guidelines [10]

On the other side of the issue is the International Lyme and Associated Diseases Society [ILADS]. It’s an organization of doctors who treat the patients who are cast adrift by the IDSA’s Lyme viewpoint.

ILADS is a non profit, international, multidisciplinary medical society that strongly support physicians, scientists, researchers and other healthcare professionals dedicated to advancing the standard of care of Lyme and associated diseases. There is a bare mention of the ILADS 2014 treatment guidelines at the bottom of the PHAC web page on Lyme and no mention of them on the Nova Scotia 2019 IDEG statement on management of Lyme disease where they have printed the out-of date IDSA Guidelines.

The scientific evidence in Lyme research is generally weak, but it is just as weak for the IDSA and ILADS guidelines. This is primarily due to the paucity of good solid scientific research, at least up until quite recently. In studies where good data is available, some of it is ignored and the results open to differing interpretations. At least ILADS goes to considerable lengths to analyze what is available; they point out the deficiencies and then actually tell people what is weak. In the face of uncertainty, ILADS guidelines defer to physician’s clinical judgment and patient preferences.

  • Conference to Develop a Federal Framework on Lyme Disease

Canadians have made it very clear that we want a made-in-Canada solution and don’t want to have our medical system controlled by the U.S. Health Insurance industry.

The Conference to Develop a Federal Framework on Lyme Disease was held in Ottawa in May 2016 to do just that. The Act called for a made-in Canada set of guidelines. [30] The conference was balanced and diverse expert opinions and patient testimonials were given. The Canadian Lyme Disease Foundation (www.CanLyme.org) recorded the whole event expecting sabotage and these video recordings are available the CanLyme YouTube Channel. [31]

The Summary Report was released in December 2016 and was expected to form the basis of the Framework. [32] Subsequently the chairman, Dr. Greg Taylor retired, or moved aside and was replaced by Dr.Theresa Tam now Canada’s Chief Public Health Officer and her deputy, Dr. Howard Njoo. Both of these individuals are senior infectious disease doctors and likely have close ties to AMMI/ IDSA, the CDC and WHO. The Summary Report was followed by a status quo draft report that didn’t follow the conference or the summary report. Over four hundred written objections were received and ignored. The final status quo Framework is a travesty, was completed without consultation or transparency and could have been written a decade earlier. It was designed to convince the politicians that they were in good hands. [33]

No new made-in-Canada guidelines were produced and the Framework is not in compliance with the act. It cedes authority back to the same individuals who are the cause of the problem. The $4 million arising from the conference was granted to a single research team after the Canadian Institutes of Health Research [CIHR] decided that a competition wasn’t needed. The Canadian Lyme Disease Research Network [CLyDRN] is made up of paid employees of PHAC, provincial public health officials and status quo researchers. This group will use the money to control the agenda and cement old ideas.

Our public health agencies should attract and encourage people with diverse opinions on the subject of Lyme and be encouraged to express their views and explore new areas of research on Lyme and TBD’s.

There have been a few meetings with representatives from the Lyme community but members have been siloed and met with closed minds. The only topic that they have been allowed to discuss is prevention when we are capable of so much more. This is not meaningful consultation and patients are being used as window dressing.

Dr. Howard Njoo stated that PHAC will not lead and the provinces are free to do as they please. This isn’t true as PHAC is still the gatekeeper by controlling the testing at the National Microbiology Laboratory [NML] and false negative test results are likely to deprive even more Canadians of appropriate treatment. PHAC has given up on its central role to protect Canadians and now claims that health is a provincial issue. They are not assessing how this ignored epidemic is affecting the health of Canadians. We are more than 30 years behind in research.

Health Ministers still employ the usual pre-formatted line that the province follows evidence-based guidelines. For research and science to become evidence, it requires transparent debate with stakeholders. There is no more important stakeholder in health care than the sick patient and their experts. No such debate has been allowed in Canada. The guidelines they refer to prune the research database and cite only that which supports their pre-determined assumptions while ignoring volumes of research that show their assumptions are incorrect. This is a long-standing tactic of the private and highly industry influenced IDSA and its puppet organization in Canada, the private AMMI of Canada.  Both of these organizations are anti-evidence, anti-science and are criticized globally by true scientists. Canadians are in real danger so long as our politicians and taxpayer salaried pseudo-scientists are allowed to ignore the ethics of science and Canada’s commitment to the highest quality of health care.

All these different organizations such as Health Canada, PHAC, the Pan Canadian Public Health Network, CIHR, NML, AMMI and now CLyDRN speak with one voice on the Lyme file but that does not make them scientifically correct.

  • Diagnosing and Testing for Lyme

Lyme has always been defined as a clinical disease. There are reliable tests for most medical conditions these days but not Lyme. Most physicians are uncomfortable with diagnosing Lyme disease clinically when they have never been properly taught how to do so.

Many Canadians are familiar with the significance of an expanding EM rash and particularly a bull’s-eye rash. True, not every rash is due to Borrelia bacteria responsible for Lyme.  The problem comes when you realize that less than 50% of patients get any sort of rash, Less than 9% get a classic bull’s-eye and less than 50 % recall a tick bite. In a study of 17 Nova Scotian children none of them remembered being bitten and none of the referring physicians suspected Lyme disease and only 18% had a rash, not the 70%-80% claimed by the CDC. The study’s author said in a press interview “-it’s not like we were taught about Lyme disease in medical school.” [36] Not everyone will get an identifiable fever or flue-like symptoms. Those few lucky enough to get a classic bull’s-eye rash or flue like symptoms in summer who do get early treatment do very well. However 10%-20% will remain ill. [3,4]

Doctors are not told about all the possible diverse presenting symptoms except for the over-emphasized rash, Bell’s palsy, flue-like symptoms and heart block. [36,37] A coin toss will produce a better result than the initial ELISA test which depends on a measurable antibody response. The sensitivity of the test for HIV is 98.6% while the test for Lyme is 46%. [38,39] This is 1960’s medicine and is an anachronism in this age of precision and personalized medicine. Doctors are told the test is highly reliable except in the first 4-6 weeks when the body hasn’t had time to develop an antibody response.

The test for Lyme was developed to help inform the clinician and help confirm their clinical diagnosis. It has been used to exclude patients that are likely positive. These tests developed for Lyme are considered to be the gold standard because the IDSA/ CDC is not prepared to offer anything else. They are reliably inaccurate and cannot be used to rule out Lyme –yet this is what is taking place.

These badly flawed serological tests are what has gotten into so much trouble and should be scrapped. This is a clinical disease and must be diagnosed clinically. Serological tests were only ever meant to help the physician confirm their diagnosis. Antibody based laboratory testing is extremely problematic for a wide range of reasons and the threshold set so high that few can test positive, particularly when a patient’s immune system has become dysfunctional.

Infectious diseases [ID] push the flawed serological testing to the top of the hierarchy. [34,35]

Physicians are not made aware of the limitations printed on the Immunotec package inserts or the 2012 Health Canada web site warning of significant test limitations. [40,41]

  • “A diagnosis must be made based on the history and signs. Negative results shouldn’t be used to exclude Lyme disease.” “Serologic test results are supplemental to the clinical diagnosis of Lyme disease and should not be the primary basis for making diagnostic or treatment decisions.”
  • Lyme disease test kits have sensitivity and specificity limitations.

In a court of law these words would mean something but are simply being ignored.

The worst thing you can do for a patient is give them a false negative test result yet ID warn of false positives and exaggerate the potential harm from treatment while downplaying the harm from denying or delaying effective therapies. No testing is done for co-infections in Canada.

Warning Canadians not to use foreign inspected and accredited labs is a red herring. These commercial labs test against a wider variety of Borrelia species found in the environment. They do not, as AMMI members claim give you the diagnosis you pay for. Unlike the Canadian National Microbiology Lab [NML] in Winnipeg they return the lab results which are open to interpretation and allow the physician and patient to make the diagnosis and agree on a treatment plan. With no knowledge of the patient history or symptoms NML make a binary diagnosis based on the test result and refuse to return the test to the healthcare provider. Canada has no mechanism for better testing due to bureaucratic controls that are influenced by for-profit players, and not victims and their experts.

The test result should be returned with a note signed by the doctor that a negative test result does not necessarily mean you don’t have Lyme disease. “If symptoms worsen…return to your health care provider for further testing.”

AMMI claim the commercial labs use non-validated tests. In order to validate these tests Health Canada would like the commercial labs to turn over their proprietary reagents for testing in Canada. That isn’t going to happen. AMMI have been asked to show evidence in the literature that commercial labs are doing anything wrong and so far they haven’t produced any.

The NML test was developed for a single strain of Borrelia found in New England long before the complexities of the disease were understood. Our ticks carry different strains of Borrelia in different parts of Canada and the test is not able to identify all of these or strains brought across the Atlantic and Pacific by seabirds or the new strains we are only now discovering. [42,43,44]

The history of Lyme disease follows a similar pattern to other new and emerging diseases. Long before officials recognized the complexities involved they modeled the disease with a rigid template and from then on studied the model and not the actual disease. The IDSA attempt to place Lyme in a box and have confused the actual disease with their test. They have defined the disease too narrowly and set the bar to high for most patients to cross. We don’t even agree on the definition

IDSA/ AMMI Definition: “Lyme borreliosis is caused by the spirochete Borrelia burgdorferi B- 31 and is transmitted by deer ticks [Ixodes scapularis].”

Canadian Lyme Disease Foundation [www.CanLyme.org]definition: “Lyme disease is a tick-borne zoonosis caused by several genospecies of the spirochete Borrelia burgdorferi sensu lato -sl.” [In the broad sense]

Treatments for Lyme and TBD’s

Prof. Ying Zhang compares current treatments to pretending to kill dandelions with a lawnmower. Lyme is a complex disease like leprosy, TB or its cousin syphilis. TB should be the model to use. Eventually over the years clinicians learned to use a combination of 3 antibiotics and reduce the treatment time for TB from 2 years to 3 months. [45,46,47] Dr. Lambert can’t understand why he can treat a TB patient for 3-6-18 months but is treated as a criminal if he prescribes more than 3 weeks of doxycycline for a Lyme patient.

Dr. Lambert started with AIDS patients and is a member of both the IDSA and ILADS. His views changed on Lyme when he started listening to his patients. The disease they were describing was not what he had been taught. He says IDSA guidelines for other disease are very good but when he checked those for Lyme he found that they were pruned of all science that didn’t agree with dogma. [48] Both He and Calgary’s Dr. Ralph Hawkins are form the Osler school of medicine. “Listen to your patient – he is giving you the diagnosis.” Both find that each case is unique and has to be treated differently. When asked which guidelines they use they both say they treat their sick patient.

Both have been asked if they aren’t concerned about the overuse of antibiotics. The response is that their responsibility is to their sick patient. The antibiotic problem that arose from their misuse in agriculture shouldn’t be the only preoccupation of PHAC when they are ignoring a Lyme and TBD epidemic in plain site. Keep in mind that it is the appropriate use of antibiotics that is important. This is not a good time to use very sick Lyme patients as scapegoats.

We now know from years of experience with Lyme patients that time is the most important factor. High dose short-term treatments fail where as long-term low dose treatments using combinations of antimicrobials to take care of the many forms Borrelia can take do tend to work best. There is more to this disease than killing bugs. This is a multisystem disease and often other medications such as gabapentin are required to control neurologic symptoms.

Dr. Ken Leigner has just published a paper on the treatment of 3 refractory Lyme cases with a repurposed drug, disulfiram (antibuse) used for treating alcoholism. Currently Dr. Brian Fallon is running controlled trials of the drug on patients at his Columbia University Lyme and TBD Research Center and the results should be out within 18 months. [49]

Dr. Neil Spector, a Duke University cancer researcher who nearly died from complications of Lyme disease, is now turning his attention to finding innovative therapies for Lyme and Bartonella using targeted molecular therapies and smart drug design to identify protein binding targets to deliver payloads directly to Borrelia while leaving our healthy cells and microbiome intact. His group has identified compounds previously approved by the FDA that will penetrate biofilm and Borrelia allowing the organism to be killed using fusion technology and SPECT CT and red light therapy. [50]

Another potential treatment has come from repurposing a leprosy drug [daptomycin] and combining it with two other antibiotics clears persistent Borrelia infection in mice. [51]

We hope these newer approaches will work but that brings up another issue. These developments have had to be privately funded because our elected representatives have been convinced not to waste scarce resources on persistent/ chronic Lyme disease that isn’t officially recognized with a description or ICD-11 code.

  • A Canadian Approach

Perhaps there should be a Canadian approach to the problem where two guidelines with differing approaches exist, which would allow healthcare professionals to use their clinical judgment to tailor treatment based on individual patient’s circumstances. Most patients know that that they should be given treatment options and that they should be told the risks and benefits of different treatment approaches to Lyme disease. Both the IDSA and ILADS guidelines are based on many of the same research trials but interpreted differently. In addition the ILADS guidelines include more recent research. The primary difference between the IDSA and ILADS guidelines is that in the face of scientific uncertainty, ILADS defers to clinical judgment and patient preferences while the IDSA makes very strong recommendations against treatment and severely restricts the application of clinical judgment. There are about 25 conditions with multiple treatment guidelines. Why not involve the patient in the decision making since not to do so is unethical? [52,53]

  • Conclusion

Lyme is the 21st Century plague that became too expensive for insurance

companies to treat with unacceptable testing, inadequate treatment, lack of medical training and absolutely no disease control; a public health disaster.

IDSA and AMMI have convinced our elected representatives that all the problems have been solved and questions answered. Science is a methodology, not a belief system and science can bridge the gap but there is never enough money for even basic research on Lyme disease. Patients and patient experts do not accept that the scientific questions have all been answered and can now be simply accepted as being absolute truths. All of us need to understand that science is rarely settled and acknowledge that science is always evolving. The fact is that the science is woefully incomplete on pathogenic borreliosis, especially relative to morbidity and mortality, so setting diagnostic and treatment guidelines in stone at this point is anti-scientific in its very nature.

Our publicly funded healthcare system does not necessarily have the same priorities and outlook as healthcare in the United States. It would be far better to stop following in the footsteps of the CDC, the policies of which have failed to stem the risk and rate of Lyme infection which have both steadily increased.  According to the CDC itself, Lyme infection rates in the U.S. are now estimated to be at over 1,000% the rate they were one decade ago. [54]

The lack of accurate disease reporting leads to a reduction in public health awareness and medical education in areas where it’s needed. This then hinders a patient’s access to timely and accurate diagnosis and early treatment—which are absolutely critical to a good prognosis.

Most Canadian patients, and particularly those with late stage Lyme, have to travel out-of-country to get diagnosed and treated with combinations of long-term antibiotics and possibly other medications for associated neurologic complications, all at their own expense.  A relatively simple case could take six months to treat and most people require at least a year and a half. Whole families are sometimes infected and they simply cannot afford the costs of travel and treatment. For Canadian residents, being unable to access timely and/or appropriate effective care in Canada for Lyme disease is unacceptable and a travesty.

How many more Canadians need to loose their jobs, homes and lives to essentially what is a treatable disease and ignored epidemic? At last it seems the tide may have started to turn.

The opinions expressed are those of the author.

Rob Murray [DDS-ret’d]

Lunenburg, NS

email: murrayrgm01@gmail.com

tel. 902-634-8542

Board member Canadian Lyme Disease Foundation

Board member Lunenburg Lyme Association

Resources:

Conquering Lyme Disease; Science Bridges the Great Divide, Brian A. Fallon, MD and Jennifer Sotsky, MD, Columbia University Press 2018

Cure Unknown; Inside the Lyme Epidemic, Pamela Weintraub, St Martin’s Griffin Revised Edition 2013.

Lyme, The First Epidemic of Climate Change, Mary Beth Pfeiffer, Island Press 2018

References:

1.)  Tick Borne Diseases Response Plan 2019: 2019-04, Nova Scotia Zoonotic Diseases Working Group: https://novascotia.ca/dhw/cdpc/documents/Tick-Borne-Disease-Response-Plan.pdf SEE: Page 6: 438 cases in 2018

2.)  Under-Detection of Lyme Disease in Canada, Lloyd VK, Hawkins R,       Healthcare 2018, 6[4], 125; doi:10.3390/healthcare6040125

https://www.mdpi.com/2227-9032/6/4/125/htm

3.  Controversies in Persistent [Chronic] Lyme Disease, Maloney EL, J Infus Nurs. 2016 Nov, 39[6]: 369-375:  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5102277/

4.)  Reconciling Borrelia Biology and Clinical Conundrums, Bamm VV, Wills MKB, et al., Pathogens, Frontiers 19-12-16; 8 [4], 299: https://doi.org/10.3390/pathogens8040299  https://www.mdpi.com/2076-0817/8/4/299

5.)  A Multiple Streams Approach to Understanding the Issues and Challenges of Lyme Disease Management in Canada’s Maritime Provinces, Levesque M,

      Klohn M, Int J Environ Res Public Health; 16[9]: 1531, Published online 19-04-30: doi: 10.3390/ijerph16091531

https://www.mdpi.com/1660-4601/16/9/1531/htm

6.)  Prevalence of Lyme disease is a big and growing problem – let’s look at       the numbers, Johnson L, Lyme Policy Wonk, Lymedisease.org 19-01-03:

https://www.lymedisease.org/mylymedata-lyme-disease-prevalence/

7.)  Suicide and Lyme and associated diseases, Bransfield RC, Neuropsychiatric Dis Treat, 17-06-16: 13; 1575-1587:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5481283/

8.)  Under Our Skin: https://underourskin.com

9.)  Metamorphoses of Lyme disease spirochetes: phenomenon of Borrelia persisters, Rudenko N, et al. Parasite Vector 19-05-16; 12: 237:https://parasitesandvectors.biomedcentral.com/track/pdf/10.1186/s13071-019-3495-7

https://doi.org/10.1186/s13071-019-3495-7

10.) ILADS Guidelines 2014, Expert Review of Anti-infective Therapy. http://www.tandfonline.com/doi/full/10.1586/14787210.2014.940900

11.)  The GRADE process for evaluating scientific evidence, an introduction: http://ktdrr.org/products/update/v1n5/dijkers_grade_ktupdatev1n5.pdf

12.)  Guidance for Primary Care and Emergency Medicine Providers in the         Management of Lyme Disease in Nova Scotia, IDEG May 2019: https://novascotia.ca/dhw/cdpc/documents/statement_for_managing_LD.pdf

13.)  Conflicts of Interest in Lyme Disease: Lab Testing, Vaccination and         Treatment Guidelines, Lyme Association Inc., 2001- 04: https://lymediseaseassociation.org/wp-content/uploads/2001/04/ConflictReport.pdf

14.)  The Infectious Diseases Society of America Lyme guidelines: a cautionary tale about the development of clinical practice guidelines, Johnson L, Stricker RB, Philos Ethics Humanit Med 5 [9] 10-06-09: https://peh-med.biomedcentral.com/articles/10.1186/1747-5341-5-9

15.)  Clinical Practice Guidelines We Can Trust, IOM 2013: http://data.care-statement.org/wp-content/uploads/2016/12/IOMGuidelines-2013-1.pdf  see Box 3.1

16.)  Analysis of Overall Level of Evidence Behind Infectious Diseases Society of America Practice Guidelines, Lee DH, Vielemeyer O, Arch Intern Med 11-01-10; 171 [1] 18-22: doi:10.1001/archinternmed.2010.482 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/226373

17.)  The Ad Hoc Patient and Physician Coalition Comments of the IDSA          Proposed Lyme Guidelines, Lymedisease.org 19-09-06:  https://www.lymedisease.org/wp-content/uploads/2019/09/Ad-Hoc-Patient-Physician-Coalition-Comments-Sept-6.pdf

18.)  Centers for Disease Control and Prevention: protecting the privategood?          Lenzer J, BMJ 15-05-15: 350 doi: https://doi.org/10.1136/bmj.h2362

https://www.bmj.com/content/350/bmj.h2362

19.)  Insurers Accused of Conspiring to Deny Lyme Disease Coverage, Langford, Courthouse News Service, 17-11-14:

20.)  Prof. Holly Ahern speaks at Focus on Lyme 2017, YouTube 17-08-30         https://www.youtube.com/watch?v=wm04_5AneBc length 31:09

21.)  Abandon “Post-Treatment Lyme Disease Syndrome” label, Johnson LD, Lyme Policy Wonk, Lymedisease.org 18-12-11: https://www.lymedisease.org/lymepolicywonk-abandon-post-treatment-lyme-disease-syndrome-label/

22.)  Chronic Lyme Disease: An Evidence-Based Definition by the ILADS Working Group, Shor S et al., Antibiotics 19-12-16; 8 [4] 269: https://doi.org/10.3390/antibiotics8040269  https://www.mdpi.com/2079-6382/8/4/269/htm

23.)  Garth Ehrlich, Focus on Lyme Scientific Conference 2019, YouTube 19-04-16: https://www.youtube.com/watch?v=pKGiEj3OHY8 length 40:50

24.)  Evidenced based, Patient Centred Guidelines, Guidelines and Best          Practices, Maloney E, Ottawa Conference #13, Conference to Develop a          Federal Framework on Lyme Disease, YouTube 16-09-09:          https://www.youtube.com/watch?v=eN9yS_2tIk0 length 20:09

25.)  For health professionals: Lymedisease, PHAC 18-12-12: https://www.canada.ca/en/public-health/services/diseases/lyme-disease/health-professionals-lyme-disease.html

26.)  Lyme disease is steeped in controversy. Now some doctors are too afraid to treat patients, Teotonio I, thespec.com 18-12-14: https://www.thespec.com/living-story/9082958-lyme-disease-is-steeped-in-controversy-now-some-doctors-are-too-afraid-to-treat-patients/

27.)  2006 IDSA Guidelines; The Clinical Assessment, Treatment and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis and Babesiosis: Clinical Practice Guidelines by the Infectious Diseases Society of America, Wormser GP, Dattwyler RJ, Shapiro EP et al.: https://watermark.silverchair.com/43-9-1089.pdf

28.) The Standard of Care in Malpractice Cases: Irvin Sherman, Osgoode Hall Law Journal, York University, Article 4, Vol. 4 [2] 1966-09, Excerpt: p225 “A doctor need not follow the procedures adopted by a unanimous majority of doctors. If a doctor follows a procedure adopted by a reputable minority of practitioners, it will suffice to disprove any inference of negligence.

29.)  Ontario doctor cleared of misconduct, 2013:  http://www.canlii.org/en/on/onhparb/doc/2013/2013canlii68994/2013canlii68994.html

30.)  Federal Framework on Lyme Disease Act 14-12-16:

https://laws.justice.gc.ca/eng/AnnualStatutes/2014_37/FullText.html

31.)  Ottawa Lyme Framework Conference Full, YouTube 2016: 

https://www.youtube.com/channel/UCbvRlKgYPsuQuK9coZKDoiw

32.)   Conference Summary Report:

http://www.healthycanadians.gc.ca/publications/diseases-conditions- maladies-affections/summary-report-lyme-2016-conference-rapport-sommaire/index-eng.php

33.)  Lyme Disease in Canada – A Federal Framework 17-05-30:

https://www.canada.ca/en/public-health/services/publications/diseases-conditions/lyme-disease-canada-federal-framework.html

34.)  The Need for Clinical Judgment in the Diagnosis and Treatment of Lyme

        disease, Maloney EL, Jpands 2009:

http://www.jpands.org/vol14no3/maloney.pdf

35.)  Guidance for Primary Care and Emergency Medicine Providers in the

Management of Lyme Disease in Nova Scotia, IDEG 2019: https://novascotia.ca/dhw/cdpc/documents/statement_for_managing_LD.pdf

36.)  Lyme Arthritis: an Emerging Clinical Problem in Nova Scotia, Canada,

        Arthritis & Rheumatology, Glaude PD, Huber AM, Mailman T, Ramsey S,

        Lang B, Stringer E, A82: Wiley Online Library 14-04-04:

https://doi.org/10.1002/art.38498

37.)  Lyme disease symptoms, Canadian Lyme Disease Foundation:  

38.)  October 2012 Health Canada Bulletin Vol. 22 Issue 4  …Limitations of Lyme

        testing. Kit. “Cannot reliably be used to rule out Lyme disease.”

http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v22n4-eng.php

38.)  Two-Tiered Lab Testing for Lyme Disease—No Better Than a Coin Toss.

        Time for change? Johnson L, Lyme Policy Wonk, Lymedisease.org 17-10-

09: https://www.lymedisease.org/lymepolicywonk-two-tiered-lab-testing-for-lyme-disease-no-better-than-a-coin-toss-time-for-change-2/

39.)  Analysis shows standard Lyme testing is highly inaccurate, Marcum L, Lyme

        Sci, Lymedisease.org 17-01-13:

https://www.lymedisease.org/lyme-sci-testing/

40.)  October 2012 Health Canada Bulletin Vol. 22 Issue 4  …Limitations of Lyme

        testing. Kit. “Cannot reliably be used to rule out Lyme disease.”

http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v22n4-eng.php

41.)  Immunetics C6 Lyme ELISA Kit Package Insert:

http://www.oxfordimmunotec.com/international/wp-content/uploads/sites/3/CF-E601-810_Manual.pdf

 42.)  Lyme Borreliosis in Canada: Biological Diversity and Diagnostic Complexit

         from an Entomological Perspective, Sperling JLH, Sperling FEH, BioOne

09-11-01: https://bioone.org/journals/the-canadian-entomologist/volume-141/issue-6/n08-CPA04/Lyme-Borreliosis-in-Canada–Biological-Diversity-and-Diagnostic-Complexity/10.4039/n08-CPA04.full

43.)  Evolving Perspectives on Lyme Borreliosis in Canada, Sperling JLH,

        Middelveen MD, Klein D, Sperling FAH, Open Neurol J. 2012-10-05, 6: 94–

103: doi: 10.2174/1874205X01206010094  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3474999/

44.)  Evolutionary Aspects of Emerging Lyme Disease in Canada, Ogden NH, et

al., Appl Enviro Microbiol 2015-11 81 [21]: https://aem.asm.org/content/aem/81/21/7350.full.pdf

45.)  Persisters, persistent infection and the Yin-Yang model, Emerging Microbes

& Infections, Zhang Y, vol 3, page e3 [2014] Nature.com:  https://www.scienceopen.com/document_file/e1237689-dd8a-4d8b-bf60-df3df7561249/PubMedCentral/e1237689-dd8a-4d8b-bf60-df3df7561249.pdf

46.)  Why persister cells matter with Lyme Disease, Zhang Y, Marcum L, Lyme Sci, Lymedisease.org 17-01-23: https://www.lymedisease.org/lyme-sci-why-persister-cells-matter-with-lyme-disease/

47.)  3rd Annual “Lyme Disease in the Era of Precision Medicine” Conference:

        Ying Zhang, New York Academy of Medicine, YouTube 18-10-19:

        https://www.youtube.com/watch?v=op48l-XifTg length 27:54

48.)  Dr. Jack Lambert Kerry Lawless Health Committee, YouTube, 18-11-29: https://www.youtube.com/watch?v=bSyostXIZVU Total length 26:54

49.)  Disulfiram [Tetraethylthiuram Disulfide] in the Treatment of Lyme Disease

       and Babesiosis: Report of Experience in Three Cases, Liegner KB,

       Antibiotics 19-05-30: 8 [2] 72; https://doi.org/10.3390/antibiotics8020072

https://www.mdpi.com/2079-6382/8/2/72

50.)  The State of the Art: Therapeutic Strategies for TBD’s, Dr. Neil Spector’s

        presentation from LymeMIND conference 2019, 4th Annual “Lyme Disease

        in the Era of Precision Medicine” Features – Focus Opinions,

        Lymedisease.org, YouTube 19-12-09:

        https://www.youtube.com/watch?v=yiQsp1rTyAU length 50:23 see red

        light therapy at 28:28

51.)  Three-antibiotic cocktail clears ‘persister’ Lyme bacteria in mouse study,

        John Hopkins, Bloomberg School of Public Health 19-04-24:

https://www.eurekalert.org/pub_releases/2019-04/jhub-tcc042319.php

52.)  Two Standards of Care, Johnson L, Lyme disease.org, 15-01-07

https://www.lymedisease.org/wp-content/uploads/2016/07/2016-two-standards-of-care.pdf

53.)  Shared decision-making in medicine, Wikipedia:

https://en.wikipedia.org/wiki/Shared_decision-making_in_medicine

54.)  CDC Press Release, 13-08-19,

http://www.cdc.gov/media/releases/2013/p0819-lyme-disease.html

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