May 25th, 2018

The below is taken from the Public Health Agency of Canada (PHAC) website.  It is a guideline for health professionals yet PHAC states they do not publish guidelines (when talking to patient groups).  It does nothing for the several other serious diseases ticks transmit to humans and fails what we currently know about their very narrow definition of what Lyme disease is.

They were specifically and clearly instructed to create guidelines working with patient stakeholders via Bill 442… they did not follow the law.  Apparently bureaucrats can thumb their noses at our legislators with zero consequence?  Members of Parliament where are you??  How many more have to die, or lose their homes just to get help outside of our health care system that the bureaucrats run??

The below guideline does not reflect GRADE level evidence-based science and should be removed from our tax payer funded website, and any further publication must be developed with the patient groups and their experts having direct input with veto power to ensure appropriate science is guiding healthcare, AFTER ALL IT IS THE PATIENT AND THEIR FAMILIES WHO EITHER BENEFIT FROM OR BECOME THE VICTIM OF MEDICAL GUIDELINES THAT THEN BECOME EMBEDDED IN THE CURRICULUM AT MEDICAL SCHOOLS.

OUR COMMENTS ARE IN BLUE TEXT IN THE BELOW DOCUMENT….

“For health professionals: Lyme disease

Find detailed information on Lyme disease for health professionals.

On this page

• What health professionals need to know about Lyme disease
• Clinical manifestations
• Diagnosis
• Laboratory testing
• Treatment
• Prevention
• Lyme disease surveillance in Canada
• Removing and submitting ticks for testing
• For more information

What health professionals need to know about Lyme disease

Lyme disease is a serious illness caused by the bacterium Borrelia burgdorferi. [time to start acknowledging the other strains/genotypes of borrelia known to occur in Canada that are pathogenic. There is zero emphasis on anything other than B.burgdorferi.]. The bacterium is a spirochete transmitted by certain species of Ixodes ticks.[other forms of transmission] It is spread through the bite of infected blacklegged ticks and western blacklegged ticks.

Health professionals are encouraged to further their knowledge of Lyme disease in Canada. This includes the ability to:

• understand and identify the signs and symptoms
• prescribe appropriate treatment for patients diagnosed with the disease
• report human cases through appropriate channels

Clinical manifestations

Symptoms sometimes appear in overlapping stages, as:

• early localized Lyme disease
• early disseminated Lyme disease
• late disseminated Lyme disease

It is important to note that some people with Lyme disease may have no or minimal symptoms. Others may suffer more severe symptoms.

Some people may not develop symptoms until weeks after the initial bite, as described in the early localized disease stage below. In this case, they may not remember the tick bite or associate the illness with the bite. Because the blacklegged tick is so small and usually painless, some people may not even know they were bitten by a tick.

Health professionals should be knowledgeable about the clinical manifestations and epidemiological risk factors of Lyme disease. Consider Lyme disease as part of your differential diagnosis in a patient who presents with compatible symptoms and signs.

Accurate diagnosis and immediate treatment are key factors to the successful management of Lyme disease.

Early localized Lyme disease (less than 30 days)

Early localized Lyme disease usually presents as an acute illness characterized by:

• fever
• arthralgias
• myalgias
• headache
• the presence of a single, localized skin lesion known as erythema migrans (EM) [This is a false statement. Where is the evidence that this rash is a “usual” presentation of Lyme borreliosis? Most people get no rash, according to latest research only a small subset of borrelia will cause a rash of any kind. ]

Not all patients will present with an EM. Therefore, diagnosis should not be based solely on the presence of EM.

Most patients will present with EMs (again, the evidence please) within 7 days of the initial tick bite. However, the incubation period can vary between 3 and 30 days.

The skin lesion is characteristically an annular erythematous lesion greater than 5 cm in diameter that: requires a reference for the size of rash in children

• slowly increases in size
• is usually painless and non-pruritic

The lesion sometimes develops central clearing, but it can be more homogenously erythematous. In dark-skinned patients, the rash may appear more as a bruise.

Variations of an EM are highly suggestive of Lyme disease and can take the following forms:

• blistering
• solid lesions
• crusted lesions
• blue-purple hues
• a bull’s-eye appearance (in only 9 percent of the percentage who do get a rash)

A skin lesion called erythema migrans can develop into a bull’s-eye at the site of a tick bite. It is shown here on a patient’s upper arm.^Footnote1 

A typical sign of early non-disseminated Lyme disease (not typical, again, a false statement not backed by evidence) is an expanding rash called erythema migrans. This can take on the appearance of a bull’s eye.^Footnote1

Some Lyme disease skin lesions are uniformly red and do not appear with the classic ring.^Footnote1
Some patients present with a central blistering lesion, commonly mistaken as a spider bite. This is likely due to an inflammatory reaction to the pathogen induced by the tick.^Footnote1

Some skin lesions caused by Lyme diseases have a blue-purple colour. They are distinct from bruises as the perfectly uniform circle has a sharply demarcated border.^Footnote1

Lyme disease is spread through the blood to other areas of the body. Therefore, a bite may lead to multiple skin lesions, taking variable shapes.^Footnote1

Some people may have minor symptoms. Therefore, it is best not to make a diagnosis based solely on the presence or absence of a bull’s-eye rash. Consider other signs and symptoms as part of your differential diagnosis of the disease, including: This list below is very misleading and far too short. It ignores many multi-systemic symptoms.

• fatigue
• arthralgia
• headache
• low-grade fever

Early disseminated Lyme disease (less than 3 months)

If untreated, the bacterium causing Lyme disease can:

• disseminate via the bloodstream to other body sites
• provoke damage to body tissues at those sites

Symptoms can include:

• fatigue and general weakness
• cutaneous signs (for example, multiple EM lesions)
• cardiac manifestations are:
  • atrioventricular block
  • tachyarrhythmias
  • myopericarditis
  • myocardial dysfunction
• neurological symptoms, such as:
  • aseptic meningitis
  • radiculopathy
  • encephalopathy
  • cranial neuropathy (especially facial nerve palsy) most people do not get facial nerve palsy so why “especially”?
  • mononeuritis multiplex
  • subtle cognitive difficulties (not subtle in many people)
  • motor and sensory radiculoneuropathy
• other rare manifestations, such as:
  • uveitis
  • keratitis
  • conjunctivitis
  • mild hepatitis
  • splenomegaly

There are many more complex symptoms not listed here above and below (see the ICD code updates submitted to the World Health Organization)

Late Lyme disease (more than 3 months)

If it remains untreated, late Lyme disease can last months or even years.

Symptoms could be musculoskeletal, such as in the form of:

• Baker’s cyst
• chronic arthritis
• asymetric oligoarticular arthritis (usually affects the knees)
• transient, migratory arthritis and effusion in 1 or multiple joints

If untreated, arthritis may recur in the same or different joints.

Symptoms can also be neurological, such as:

• subacute mild encephalopathy, affecting:
  • memory
  • concentration
• chronic mild axonal polyneuropathy, manifested as:
  • distal paresthesias
  • radicular pain (less common)
• encephalomyelitis (rare)
• leukoencephalopathy (rare)

This list is far too short and misleading in its dismissiveness of the many disabling symptoms.

Symptomatic infection of the heart is rare in Lyme disease cases. However, 3 sudden cardiac deaths associated with Lyme carditis were reported in the U.S. between 2012 and 2013.

Post-treatment symptoms (post treatment presumes effective treatment when in many cases treatment failed to eradicate the organism)

Some people who were treated for Lyme disease continue to have symptoms months to years after treatment.

This condition is known as post-treatment Lyme disease syndrome (PTLDS). (Again presumes treatment was effective at eradicating the organism) Its symptoms should be managed and treated appropriately.

Diagnosis

The diagnosis of Lyme disease is primarily clinical, supported by a history of possible tick exposure (a dangerous requirement considering birds transplant these ticks randomly and efficiently across Canada anywhere.)

Not all patients will develop noticeable symptoms. As such, it is important to:

• • remember that ticks can be found outside currently identified risk areas
  • ask patients if they have travelled to or lived in an area where blacklegged ticks are established or emerging

[asking patients if they have been in an area where ticks are established is foolhardy. Most people do not have that data, and this completely ignores you can get Lyme disease in your own backyard from ticks just dropped off by robins, finches, wrens, etc. – this is a dangerous suggestion for any doctor to ask and can be very misleading because 99.9% of Canada has not been properly studied for established populations of ticks.  Why is our government supporting this unprofessional pseudo-diagnostic material??]
An additional diagnostic tool is the detection of antibodies using the two-tiered serological method described below.

However, patients with clear symptoms of early localized Lyme disease should be diagnosed and treated without laboratory confirmation. This is because false negative results are possible during the early stage of Lyme disease.

Laboratory testing

Laboratory testing should only be used to supplement clinical findings, not as a basis for diagnosis of early Lyme disease.

Two-tiered serological testing

The two-tiered serological testing approach is recommended when testing a patient’s blood for antibodies against the bacterium causing Lyme disease. This approach is validated for use in Canada and includes:

• an enzyme immunoassay (EIA) screening test
• a confirmatory immunoblot (IB) test (if the EIA is positive or equivocal)

Interpretative criteria for the EIA and IB assays have been standardized and summaries of the diagnostic approaches for Lyme disease are available.^{Footnote2 Footnote3}  If testing is required, indicate the presumed exposure area (for example, North America or Europe) on the requisition. The location will determine which tests will be used, as tests vary depending on the species of Borrelia.

In suspected Lyme meningitis, testing by an accredited laboratory for intrathecal IgG or IgM antibodies may be helpful (or very misleading due to its poor sensitivity).

All diagnostic laboratories across Canada have systems in place that are recognized by accreditation bodies, such as:

• Ontario Laboratory Accreditation
• the College of American Pathologists
• the International Organization for Standardization

This applies to all procedures conducted in the laboratory, including those specifically for Lyme disease serological testing.

These laboratories are required to:

• participate in external proficiency testing to ensure high-quality results
• be licenced by the federal government to conduct serological tests for Lyme disease

Canadian laboratory diagnostic guidelines for Lyme disease meet current international standards (they meet the US CDC standards whose standards are so low for Lyme testing that they are unethical so to brag about meeting those low standards is unacceptable). They are also consistent with those followed by public health authorities in the U.S. and Europe (again they all follow the same low standards). Public health professionals in these countries have concerns that some private, for-profit laboratories may not be using: (Our provincial and federal labs buy their Lyme test kits from for-profit labs so either remove that mention altogether or tell the complete story.)

• properly validated tests
• recommended standards for interpreting test results

We need validation and interpretation standardization done in Canada designed ‘in partnership’ with researchers, clinicians, and patients otherwise there will be no transparent ethically ‘properly validated tests’.  There certainly has been no ethical validation of any tests currently used by our various government labs.

Notes on serological tests

For patients with illness lasting over a month, only IgG testing should be performed (not IgM). A positive IgM test alone is not sufficient to diagnose current disease in these patients. (this requires rigorous open discussion)

Due to antibody persistence, a positive serological test cannot distinguish between active and past infection.

Serological tests:

• should not be done as a test of cure
• cannot be used to measure treatment response

The EIA test:

• has low specificity
• may yield false-positive results when used as a stand-alone test
• may cross-react with antibodies to commensal or pathogenic spirochetes
  • there may be some viral infections (for example, varicella and Epstein-Barr virus) for certain autoimmune diseases (for example, lupus)

The EIA also has a significant false negative rate so why is this information withheld? There are several reasons for false negative results which are the most harmful for the patient.  Again open scientific debate is required.

Treatment

The treatment regimens listed in the chart below are guidelines for localized (early) Lyme disease. The regimens may need to be adjusted depending on a patient’s:

• age
• allergies
• medical history
• pregnancy status
• underlying health conditions

Consult an infectious disease specialist for the most current treatment guidelines or individual patient treatment decisions. (this disease does not belong to infectious disease physicians who have misled the public for decades and who do not practice to standards acceptable to direct health care. For PHAC to promote this is a slap in the face to patients.)

Important treatment considerations

Doxycycline is contraindicated and amoxicillin is the drug of choice for:

• children younger than 8 years of age
• women who are pregnant or lactating

In addition, some patients may be unable to tolerate the drugs listed in the chart. In this case:

• a macrolide from the following list can be used, although it will have lower efficacy
  • azithromycin
  • erythromycin
  • clarithromycin
• patients who are treated with a macrolide should be closely monitored to ensure their symptoms are resolved

Large population studies of pregnant women with Lyme disease who received treatment have shown no increased risk of adverse outcomes.

Some experts recommend offering doxycycline as a single dose of 200 mg for people weighing less than 45 kg. An alternative is to offer doxycycline in multiple doses of 4.4 mg/kg, to a maximum dose of 200 mg. This is for people under 8 years of age who have been bitten in an area with hyper endemic infection.

There is no data on the use of amoxicillin as an alternate prophylactic antibiotic in younger children. (single dose prophylaxis will drive antibiotic resistance and the research is so poor relative to effectiveness it has no place in health care without transparent validation with patient’s experts)

Persistent symptoms following treatment

In most cases, timely treatment according to the appropriate regimen described in the chart above is effective. However, some Lyme disease patients have persistent symptoms following treatment. Research continues into the causes and methods of treatment. (and more research is required to explain the success of longer term treatment in many cases and why people’s symptoms return sometimes when antibiotics are stopped only to recover again when back on antibiotics.)

There is no definitive evidence that persistent symptoms represent ongoing infection. (This statement is false and is opinion based, not scientific) Post-infectious inflammation due to damage from the infectious process may respond to anti-inflammatory drugs.

Prophylaxis

Prophylaxis treatment can be started if the patient meets all of the following 4 criteria. (single dose prophylaxis will drive antibiotic resistance and the research is so poor relative to effectiveness it has no place in health care without transparent validation with patient’s experts)

1. The tick can be reliably identified as a blacklegged tick and is estimated to have been attached for more than 36 hours.
   • This is based on the degree of engorgement or by certainty of when the individual was bitten.
2. Prophylaxis will be started within 72 hours after the feeding tick has been removed.
3. The local rate of Borrelia burgdorferi infection in ticks is more than 20% (check with local public health).
4. Doxycycline is not contraindicated.

If all of the above criteria are met, a single dose of 200 mg of doxycycline may be given to:

• adults
• children older than 8 years of age

It should be given at 4.4 mg/kg for patients under 45 kg, up to a maximum dose of 200 mg.

(single dose prophylaxis will drive antibiotic resistance and the research is so poor relative to effectiveness it has no place in health care without transparent validation with patient’s experts)

Doxycycline is not recommended for children younger than 8 years of age or for pregnant women.

Infectious disease doctors claim to have as a large part of their mandate the responsibility of the proper use of antibiotics, yet no scientifically sound debate has been allowed to measure the quality of the evidence to support prophylaxis as a preventative measure, or the safety of exposing the microbiome within humans to such a small non-lethal dose of antibiotics that could lead to antibiotic resistance.

Prevention

There is currently no human vaccine for Lyme disease. The best way to avoid the disease is to protect against tick bites. Advise your patients to use preventive measures.

Lyme disease surveillance in Canada

Lyme disease became a national notifiable disease in December 2009.

Canada continues to monitor the evolving geographic distribution and prevalence of infected ticks and cases of Lyme disease. Therefore, you must report clinically diagnosed or laboratory-confirmed cases to your provincial or territorial public health authorities.

Health professionals in Canada play a critical role in identifying and reporting cases of Lyme disease. See the surveillance section for more information on surveillance in Canada.

Removing and submitting ticks for testing

• identify a tick
• remove a tick from the body “