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

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Cure
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Edition 2013.

Lyme, The
First Epidemic of Climate Change
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