Health Committee on June 8th, 2017

[The Chair, Liberal, Bill Casey]

Welcome to meeting number 60 of the Standing Committee on Health. We're going to continue our study of the federal framework on Lyme disease.

Today, we have a number of witnesses who have taken the time to come and visit with us today.

We have, from the Public Health Agency of Canada, Dr. Howard Njoo, acting assistant deputy minister, infectious disease prevention and control branch. From Canadian Blood Services, we have Jean-Paul Bédard, vice-president, public affairs; and Dr. Margaret Fearon, medical director. As an individual, we have by video conference Dr. Ralph Hawkins, clinical associate professor of medicine, University of Calgary. Also as an individual, we have Dr. Elizabeth Zubek, family physician, Shepherd’s Hill Medical Clinic.

Welcome to you all.

Each of you has 10 minutes for an opening statement. At nine minutes I will hold up a little red card just to remind you.

We'll start with Dr. Njoo, with the Public Health Agency.

[Len Webber, Conservative, Calgary Confederation, AB]

Mr. Chair, I do have a point of order, if you don't mind.

Please, Dr. Njoo, don't take this personally.

I thought that, according to our discussions in past meetings, we were going to have Dr. Theresa Tam here to present to us. Dr. Tam is the one who is pictured in the report, the framework, and it's just appropriate, I think, that she be here to present to us. Again, I have no beefs with having Dr. Njoo here, but is there a reason that Dr. Tam is not here today?

[Dr. Howard Njoo, Acting Assistant Deputy Minister, Infectious Disease Prevention and Control Branch, Public Health Agency of Canada]

It's just due to a scheduling conflict.

I'm also the deputy chief public health officer, just below Dr. Tam. If that suffices, I'd be pleased to speak.

[Len Webber, Conservative, Calgary Confederation, AB]

All right.

I just wanted to make you aware of that. If there are other reasons why.... I see her as the one who's pictured here on the framework. Normally, it's the minister who is pictured on the front page of any report, especially a much anticipated report. I question why Minister Philpott's picture is not on this report, but that's just another thought.

I do have one more point of order, Mr. Chair.

In past meetings, we've discussed and even put a motion forward about this meeting in particular being televised. Is it being televised? I don't think it is. We passed a motion that it was to be televised. May I ask why it is not?

[The Chair, Liberal, Bill Casey]

I'm told we weren't able to have it televised because of the video conference.

[The Clerk of the Committee, Mr. David Gagnon]

It was already booked. The other rooms were already booked by another committee. We tried, but it didn't work.

[Len Webber, Conservative, Calgary Confederation, AB]

I just think it's important because there are a lot of Lyme sufferers who are very much anticipating this meeting today and wanting to watch it. It's just disappointing that we don't have it televised for them. Instead, they'll have to read the committee Hansard, I guess.

I woke up on the wrong side of the bed this morning, and I have a couple of beefs.

[The Chair, Liberal, Bill Casey]

They're all good points. We're glad you're keeping us on track.

Are there any more, or is that it? Okay, I just wanted to make sure.

Dr. Njoo, you may go ahead.

[Dr. Howard Njoo]

Thank you very much.

Members of the committee, thank you for the opportunity to contribute to your deliberations on the federal framework on Lyme disease.

I would also like to take this opportunity to acknowledge and thank the witnesses who spoke here on Tuesday, as well as the witnesses and members here today for contributing to raising awareness and supporting Canadians with Lyme disease. As a deputy chief public health officer and a physician, I am aware of how difficult and challenging infectious diseases can be. They can be even more difficult for patients when they are left feeling as though they have not been heard.

The front-line health professionals rely on guidance developed using an evidence-based approach and the principles of the scientific method. Ongoing discussions like the one we are having here today are an important part of the response to this and other public health issues.

Lyme disease has received attention from the public and from parliamentarians and led to the introduction and passing of the Federal Framework on Lyme Disease Act in December 2014.

The framework is intended to help guide a way forward in areas where the federal government has a role, including national surveillance, guidelines and best practices, and education and awareness. Federal activities will continue to support the provinces and territories in their role in the delivery of health care services to Canadians.

Since the passing of the act in 2014, we have worked to provide Canadians with multiple opportunities to provide their input into the framework.

For example, last year the Public Health Agency of Canada hosted a conference in May to inform the development of a federal framework on Lyme disease. The conference brought together over 500 patients and their caregivers, health professionals, and federal and provincial representatives.

Earlier this year, we launched an online public consultation on the draft federal framework. The intent of this public consultation was for Canadians to review the draft framework and provide their feedback.

Through this public consultation process, over 400 individual or collective submissions and comments were received. These comments were carefully considered in the final federal framework.

On May 30, the Minister of Health formally introduced the Federal Framework on Lyme disease.

As you heard on Tuesday, Lyme disease is one of the most rapidly emerging infectious diseases in North America.

Environmental changes driven by climate change have been shown to affect the emergence and re-emergence of vector-borne diseases transmitted by mosquitoes and ticks, including Lyme disease. As the geographic range of disease-transmitting vectors expands northward, there is increased risk to Canadians of being exposed.

The Government of Canada is committed to preventing and controlling the spread of vector-borne diseases through a number of measures.

The Public Health Agency of Canada has been monitoring Lyme disease for over a decade. We have seen cases increase from 144 in 2009 to an estimated 841 in 2016.

The Public Health Agency of Canada conducts vector-borne disease monitoring and surveillance, including diseases such as Lyme disease and West Nile virus. We also work collaboratively with our partners, such as the Canadian Institutes of Health Research, to undertake research on vector-borne diseases. All of this supports the development and delivery of well-informed and evidence-based infectious disease control frameworks, strategies, and interventions.

Effectively responding to the increased risk from vector-borne diseases requires ongoing investments in disease monitoring and surveillance, knowledge and information sharing, research, professional and public education, as well as collaboration with partners and stakeholders to facilitate innovation.

Since 2016, the Public Health Agency of Canada has directed almost $3 million to better understand and respond to Lyme disease in Canada. This is in addition to Lyme disease and tick-borne disease investments made by other federal departments, like CIHR and Parks Canada.

A few key areas where the Government of Canada has been working with partners on Lyme disease include an enhanced surveillance program with provinces to collect more detailed and timely information on cases of Lyme disease; researching tick-borne diseases and providing reference laboratory testing for provinces and territories by our national microbiology laboratory; increasing awareness among Canadians on how to protect themselves and their families; and providing information to health care providers to support early identification and diagnosis of Lyme disease.

Emerging vector-borne diseases are and will continue to be a public health concern for Canadians. The prevention and control of vector-borne diseases, including Lyme disease, requires collaboration among all levels of government and non-governmental organizations.

As guided by the provisions of the Canada Health Act, provinces and territories are primarily responsible for the delivery of both direct health care services and local public health activities. Provincial and territorial public health authorities and indigenous public health authorities also undertake prevention and control activities specific to their own jurisdictions.

The framework is accompanied by a federal action plan on Lyme disease. This action plan identifies three areas for concrete action. Under the first pillar of surveillance, we will be exploring the costs associated with this disease. We will also be working with partners to establish a tick-borne surveillance system for Lyme disease and possible co-infections.

Under the second pillar of education and awareness, we recognize that clinicians can't diagnose what they don't know exists. So one of our main goals is to get the message out to health care professionals that Lyme disease is here. We will work with partners to educate health professionals on the symptoms and support them in their ability to diagnose and report cases.

As such, our action plan commits to deliver national education and awareness campaigns, so as to remedy the lack of communication regarding prevention and intervention.

Under the third and last pillar of guidelines and best practices, we recognize that the federal framework on Lyme disease does not address treatment guidelines. Clinical diagnosis and treatment of Lyme disease fall under the purview of professional associations representing front-line health care practitioners. We have committed to working collectively to strengthen evidence-based approaches through further research.

On May 30, 2017, as part of the budget 2017 investment under the pan-Canadian framework on clean growth and climate change, the Hon. Jane Philpott, Minister of Health, announced a joint effort between the Public Health Agency of Canada and the Canadian Institutes of Health Research to establish a Lyme disease research network. Investing up to $4 million in new funding, the objective of this research network will be to generate new knowledge in an effort to improve diagnosis and treatment.

The Government of Canada will also continue to support front-line health professionals and provincial laboratories through the Canadian Public Health Laboratory Network in the laboratory diagnosis of Lyme disease. All partners, including provincial and territorial health care regulatory authorities, will be consulted on innovative, evidence-based approaches to address the needs of patients.

The Public Health Agency of Canada will work with public health authorities, health care professionals, patient groups and other interested parties as we move forward together on all three areas of action.

In closing, I would like to reiterate that Lyme disease is a reality in Canada. Its effective prevention and control requires a coordinated multi-partner and stakeholder engagement approach. Through our collective efforts, Canadians will be more aware of the disease and recognize its symptoms.

As the interim chief public health officer indicated in the framework, “We will accomplish much by working together in a collaborative manner to identify and implement the solutions.”

Thank you very much for your time.

[The Chair, Liberal, Bill Casey]

Thank you very much for your comments.

Now, we go to Canadian Blood Services.

Do you want to split your time? You have 10 minutes, any way you want it.

[Jean-Paul Bédard, Vice-President, Public Affairs, Canadian Blood Services]

Mr. Chair, thank you for the opportunity to be here.

I will first use a few minutes to talk about our organization. I will then give the floor to my colleague, Dr. Margaret Fearon, who will go into more detail about the dossier we are presenting.

Canadian Blood Services is an arm's-length organization within the larger health care system. We're there, really, to manage the blood system for Canadians, with the exception of the province of Quebec. That mandate was given to Héma-Québec.

We are regulated by Health Canada, and we are funded by the provinces and territories. The ministers of health of the provinces and territories are actually our members, our shareholders, and they appoint our board of directors.

We manage blood reserves, blood products and stem cell reserves, as well as related services for all of the provinces and territories except for Quebec, as I explained earlier.

We also manage the National Public Cord Blood Bank, and we are the only authority responsible for the supply, contract manufacturing, and distribution of plasma protein in Canada.

In addition to those responsibilities, we lead an integrated interprovincial system for organ donation and transplantation for all of Canada. As part of this work, we operate the groundbreaking Canadian transplant registry and related programs.

We take many actions to protect the blood supply and ensure a safe and effective system for all Canadians. Educating donors, assessing risks via our donor questionnaire, and testing donated blood are at the heart of our multi-layered approach. Comprehensive and timely surveillance of infectious diseases also helps us to monitor the blood supply and ensure it is as safe as possible. This means we test blood donations for transmissible diseases, investigate possible transfusion-transmitted infections in blood recipients, and scan the horizon for potential or emerging threats.

We also stay current with the activities of blood operators around the world. By learning from our peers, we collect even more knowledge, data, and evidence to support appropriate policies and processes for our country.

Now I'll ask my colleague, Dr. Margaret Fearon, our director of medical microbiology, to speak to the specifics of how we approach the issue of Lyme disease for Canadians.

[Dr. Margaret Fearon, Medical Director, Medical Microbiology, Canadian Blood Services]

Thanks, Jean-Paul.

As I'm sure the committee is aware, the bacteria that causes Lyme disease is Borrelia burgdorferi, which is a spirochete, a type of organism similar to syphillis but with many different characteristics.

To date, there has been no evidence of transfusion transmission of this bacterium. In spite of the fact that several studies have looked at donors who have been infected with Lyme disease and are bacteraemic and at the recipients of blood products from those donors, there has been no evidence of transfusion transmission. In all cases those patients tested negative for Lyme disease.

Canadian Blood Services does not test blood donors for Lyme disease, and we are not alone in this. There is no blood supplier in the world that tests blood donors for Lyme disease, including the United States, which has a high prevalence, as I'm sure you know, of Lyme disease, particularly in the northeastern U.S. No one, then, tests blood donors for Lyme disease.

Given that none of the blood operators globally has expressed a demand or a need for testing for Lyme disease, none of the companies that produce these assays has developed a test and submitted it either to Health Canada or to the FDA for approval. As you know, at Canadian Blood Services all of the testing we use for screening our donors must be approved by Health Canada.

That said, the move towards pathogen reduction technologies removes the need for specific testing for each type of pathogen. Pathogen reduction technologies prevent transfusion-transmitted diseases by very effectively killing bacteria, parasites, and most viruses that may be present in the unit. The bacteria that causes Lyme disease is no different. It would be inactivated by this technology.

These technologies are gradually becoming available in Canada. There is currently a Health Canada-licensed product for the treatment of plasma, and there is another product currently under review by Health Canada for the treatment of platelets. Unfortunately, there is no pathogen reduction technology yet on the market for the pathogen inactivation of red blood cells. That is a more challenging process.

There are, however, several companies that are in clinical trials, so we're hoping that such technology will be available within the next couple of years. While there is currently no evidence of transfusion transmission of Borrelia burgdorferi, the implementation of pathogen inactivation technologies in the future would eliminate even a theoretical risk.

Today, what we currently do is defer any donors who are diagnosed with Lyme disease from donating blood. If a donor comes in and says, “I recently was told I have Lyme disease”, they are told that they are not allowed to donate until they are feeling completely well and are finished any treatment they may be on.

We also ask donors, as the first question when they come in to donate blood, “Are you feeling completely well today?” If the donor cannot answer that question with a yes, they are told that they are not allowed to donate that day.

We also ask about medications. We ask about whether donors are under a physician's care for any reason, and we defer donors if they are. This is not only for the protection of the recipient but also for the protection of the donor, because we don't want a donor who is feeling unwell donating blood, obviously.

We also ask donors, if they become ill after their donation, to contact us and let us know, and donors frequently do this. If they develop an infection or respiratory symptoms post-donation, they often will call us and let us know, and then we can make a decision on whether the unit they have donated needs to be quarantined or not.

It should be noted—because I am often asked whether we ask about tick bites—that blood suppliers in North America do not ask about a history of tick bites prior to donation. This is because individuals are often unaware that they have been bitten by a tick, and so the history in that respect is unreliable. However, if a donor volunteers that they've recently had a tick bite, we ask them to not donate that day and to come back in six months' time.

Our work and engagement in this area has been long-standing. We've been actively monitoring concerns over transfusion transmission of Borrelia burgdorferi and we have actually had many discussions about this, not only within Canada but on the committees that I sit on, which include the AABB transfusion transmitted diseases committee, and also the European Blood Alliance's emerging infectious diseases committee. There is active monitoring of this around the world.

As part of our ongoing commitment for transparency and openness, we have also engaged with stakeholders and, a number of years ago, met with patient advocates to address their concerns. We commit to continue to do that.

Thank you.

[The Chair, Liberal, Bill Casey]

Thank you very much.

Now we will move to Dr. Hawkins.

Dr. Hawkins, if you are ready, we'll have a 10-minute opening statement.

[Dr. Ralph Hawkins, Clinical Associate Professor of Medicine, University of Calgary, Cumming School of Medicine, As an Individual]

Thank you very much, Mr. Chair.

My name is Ralph Hawkins. I'm a physician with a practice in an academic medical setting in Calgary. I'm told anecdotally that my practice seeing my patients is one of the largest in Canada. Since 2012 we have evaluated more than 300 patients presenting with alternatively diagnosed Lyme disease, and we presently have over 200 patients on a waiting list to be seen. We have recently had to suspend intake of new patients onto the wait-list due to the sheer volume of demand.

My father was born in rural Saskatchewan in 1914. He died just over five years ago, but last week would have been his 103rd birthday. I want the committee to know that I admire my father and try every day to emulate his example. There were a number of things he could not abide, and being overly negative was one of them. He insisted that we always look for something good coming out of every situation, so with that lens applied, I wish to make some positive observations about the framework itself.

I appreciate the interest of parliamentarians in passing the framework act in the first place. I appreciate the efforts made by the Public Health Agency of Canada under the leadership of Dr. Taylor to engage and collaborate with all stakeholders. Those efforts paid off with the framework conference, which was noteworthy in getting stakeholders together in one venue to discuss the issues and set some priorities.

I wish I could be as positive about the activities of the Public Health Agency—I'll refer to them as PHAC from now on—in the several months following the framework meeting. Unfortunately, the framework document called “Lyme Disease in Canada” was created by PHAC without the same collaboration and engagement with stakeholders that was evident in the planning process.

I appreciate that the document mentions that human risk is increasing outside of known risk areas. I appreciate that the document mentions that cases are likely under-reported. I appreciate that the document lists as a foundation statement that all stakeholders, including patients and their advocates, health care providers, and public health authorities have important interests in making progress on Lyme disease. The document identifies three priorities that I will speak to briefly in turn.

First, on surveillance, in February 2017 provincial and territorial authorities met and agreed to implement “less burdensome” methods of tick surveillance than had been employed in the past. This concerns me if this means that surveillance will be de-intensified. The Canadian case definitions for Lyme disease were revised in 2016 and released by publication in February 2017 and demonstrated a heavy reliance on laboratory corroboration of diagnosis for reporting. This has been demonstrated to be highly insensitive in practice.

A recent publication looking at commercial diagnostic kits identifies that the sensitivity of laboratory kits presently used in practice is in the 40% to 50% range. This means that false negative test results are generated for patients truly suffering from Lyme disease in the magnitude of 50% to 60% of the time. Additionally, the number of cases counted through laboratory surveillance is magnitudes lower—perhaps fivefold to tenfold different—than cases actually occurring in provincial jurisdictions.

Second, on education and awareness, education to enhance tick awareness is needed. It is important that educational materials be accurate and contemporary. All of the pictures of the classic erythema migrans rash in educational materials are demonstrated on Caucasian white skin, but the reality of Canada in the 21st century is that we are increasingly a country of ethnic and racial diversity. The fact remains that we have erythema migrans rashes that look different on pigmented skin.

Another example is that the PHAC framework report employs maps of brisk areas that are not consistent, meaning that they are too confined when compared to contemporary published scientific literature. Additionally, the risk areas are undoubtedly going to expand over the five-year lifespan of the framework, yet the maps of risk areas will remain in the hard copies of the document for the five years. This speaks to the need for the document to be a living document with frequent updates during its lifespan. The document also states that Lyme risk occurs mainly in areas of established tick populations, but this is an unproven conjecture. The clinical diagnosis of Lyme is heavily biased by the definition of a case emphasizing exposure in a risk area.

Next on guidelines and best practices, it is a positive step that the framework acknowledges the existence of ILADS', International Lyme and Associated Disease Society's, treatment guidelines. It demonstrates a bias within the PHAC authorship that it refers to IDSA , the Infectious Diseases Society of America, guidelines as being “used by the broader medical community”, and that it relegates the ILADS guidelines to a subordinate position followed by “a small number of front-line health professionals”.

I am very concerned that the document identifies the Canadian Public Health Laboratory Network as providing the sole leadership on diagnostics. Test methods in common use in other jurisdictions are not offered in Canada due to this network's exclusion of legitimate alternative testing methodologies. For example, Liz and I attended the Best Brains Exchange on Lyme diagnostics in June 2015 where use of the T-cell test called ELISpot was discussed. The action items arising from that meeting included suggestions for lab physicians and clinical practitioners to collaborate on innovations, such as investigating the use of ELISpot, which would be useful in assisting front-line practitioners to improve diagnostic sensitivity. In the two years since this CIHR-sponsored event, however, no collaboration or innovations have been forthcoming.

As a result, practitioners still make use of laboratories in the United States or Europe to obtain lab work that could be provided in Canada. The patients are left to pay the bill for these investigations. This framework is lean on specifics of research, particularly upon who will define the research priorities, ensuring that patients and front-line providers are involved in setting the research priorities, monitoring the investments in research, and tracking outcomes. An example of how such monitoring could occur would be the U.S. Congress's recent 21st Century Cures Act, which establishes a Lyme research oversight committee with equal representation of stakeholders, including patients, caregivers, researchers, funding agencies, and legislators to set the Lyme disease research agenda and to closely monitor its progress. Your standing committee, which oversees CIHR activities, has the power to implement exactly such a measure if you choose to.

The framework has its deficiencies. It is silent on the plans to monitor congenital transmission, the blood system, or for the emergence in Canada of novel Borrelia species, including new North American and European Lyme strains.

I will close by reminding the committee of the scores of patient testimonies and the hundreds of letters that patients suffering from the disease have brought forward. These patients are suffering today. The framework gives them no hope that things will be different soon. My patients this afternoon in clinic will still be obliged to pay for out of Canada testing.

Lyme disease sufferers are an identifiable group who are being systematically wronged by a system not responsive to their plight. We are in the midst of a tragedy of our own making. During the framework conference last May, I had the honour of taking my then 13-year-old son to the House of Commons to witness the long-overdue apology for the Komagata Maru incident. It made me proud to witness a system that could be introspective, that could see and admit its wrongdoing, and to make amends for it.

I believe our system's intrinsic tendency to eventually do things right persists. Lyme disease sufferers today are being wronged. Wrongdoing is not always deliberate. Institutional wrongdoing is more often inadvertent. I would recognize the hardship of Lyme disease suffered in Canada exists today as a result of systemic institutionalized wrongdoing. As a private citizen, I would suggest to this committee that a formal inquiry would be the appropriate remedy, or perhaps my son, in his later years, will someday attend Parliament to witness the long-overdue apology to Lyme sufferers for our inaction today.

Thank you.

[The Chair, Liberal, Bill Casey]

I thank you very much.

Now we'll go to Vancouver and Dr. Zubek for 10 minutes.

[Dr. Elizabeth Zubek, Family Physician, Shepherd's Hill Medical Clinic, As an Individual]

Good morning. I'm Dr. Elizabeth Zubek, and I am a clinical instructor with the University of British Columbia Faculty of Medicine, department of family practice. I've also worked, from 2013-14, as a UBC consultant on the treatment of Lyme disease, with the university's complex chronic disease program, which was created to be a central provincial referral site for patients with Lyme disease. I now work in private practice, with the treatment of tick-borne infections occupying about 20% of my time.

I'm honoured to be chosen to speak at the House of Commons Standing Committee on Health regarding an action plan, the federal framework on Lyme disease. You, as our federal MPs, listened to the suffering of Canadians with chronic Lyme disease. You responded to the thousands of people in your constituencies who presented evidence that Lyme disease is not being properly diagnosed and treated in Canada. You had the courage to vote unanimously to create an action plan to correct these issues. Now it's time to take this information, designate the funding, and create a solution for all Canadians.

I urge you to remember the why, the impetus behind Bill C-442: Canadians becoming disabled from a treatable disease. This should inform our decisions.

Three pillars are addressed by the framework: surveillance, education and awareness, and guidelines and best practices. I would like to address each of those three pillars in succession. I'll address these from the perspective of a family physician and from the perspective of one of the few Canadian physicians specializing in the treatment of chronic tick-borne illnesses.

On surveillance, although surveillance is already being funded by the Government of Canada for Borrelia burgdorferi, we know that data obtained becomes obsolete quickly due to climate change and due to migratory birds, as they travel, spreading ticks into new areas. There is no region in Canada that can be considered safe from Lyme disease. As a family doctor, I assess the patient in front of me. If that person was bitten by a tick and develops an unusual rash, or neurological or arthritic symptoms, it doesn't matter to me whether the rate of infection in ticks in my area is 5% or 20%, I treat the person in front of me, and I need appropriate testing for tick-borne disease in that scenario.

We know there are multiple species of Borrelia, at least 10 of which cause human disease, and multiple strains among each species. There are then other Borrelia species that cause a relapse and fevers. We know that ticks carry multiple other bacteria, viruses, and parasites. I think it's more important to allocate our resources to test the sick human for the presence of disease rather than count how many ticks in a field contain the Borrelia bacteria. Surveillance has its role, and new Lyme cases are reported, but this already has some funding. Sick people need diagnosis and treatment, not more regional statistics.

Education and awareness is the second pillar. This is very important to prevent new cases of Lyme disease and to recognize symptoms of chronic infection. I believe the entire process of this framework has robustly increased education and awareness in Canadians. There's been so much press about Bill C-442, the all-party support, the controversies involved, and the media has effectively done more than any print campaign the government could have devised. As such, my recommendation would be that the dollars attached to this area of education and awareness be designated towards physician education.

I work in a region of B.C. that's considered endemic for Lyme disease, yet I frequently hear physicians saying, “Lyme disease isn't found in B.C.”, or physicians suggesting a Lyme test immediately after a tick bite, when the test couldn't possibly be positive yet. I teach final year medical students who have not learned about acute and chronic manifestations of Lyme disease. It is to physicians that educational efforts must be directed.

The third pillar is guidelines and best practices for diagnosis and management. On best practices for diagnosis, this framework recognizes that testing with better sensitivity is needed. We cannot accept the current two-tier tests, which as Ralph said, only have a 40% chance of picking up disease, and that's only if you're lucky enough to have your disease caused by one particular strain, B31, of one particular species, sensu stricto, of Borrelia.

Better tests exist now. I recommend that funding go toward evaluating the ELISpot test in our Canadian population. The ELISpot is a lymphocyte transformation test. This type of testing is accepted in Canada as the gold standard for assessing active versus latent or dormant tuberculosis, which is another spirochete disease.

The ELISpot can diagnose 84% of Borrelia infections, is positive earlier in the course of disease, and will go down to zero when treatment is completed. This has added benefit in areas of high endemicity, where a person can be reinfected after the treatment was completed. ELISpot testing currently costs between $200 and $400. Patients, as Ralph said, are now paying for it out of pocket. But it is being used by most of the treating doctors I know in Canada. Better testing for Canadians must be a top priority.

Finally, there are best practices for management. The framework recognizes there are two different approaches to management. One guideline is supported by the Infectious Diseases Society of America, IDSA, and the other is supported by the International Lyme and Associated Diseases Society, ILADS.

In evaluating the trustworthiness of any set of guidelines, specific criteria must be met, as outlined by the respected Institute of Medicine. Guidelines must include regular review and monitoring as new research becomes available. A multidisciplinary panel of experts and representatives from key affected groups, patients, update the guidelines.

Only one set of guidelines meets these criteria, the ILADS guidelines of 2014. These are on the U.S. National Guideline Clearinghouse website and used internationally. Strangely, we in Canada have not publicized these very current and evidence-based guidelines for doctors to use in Canada. We still post the old IDSA guidelines, published over a decade ago, in 2006, never revised, and which were discarded from the U.S. National Guideline Clearinghouse well over a year ago.

This is a critical point to address. There has been an explosion of research on Borrelia this past decade. We have discovered that Borrelia has three different shapes or morphologies and it switches easily between them. The three forms include a corkscrew shaped spirochete with a cell wall, an intracellular form, and a round body that is a more dormant form. It takes a different type of antibiotic to treat each one of these three forms. As a result, the most effective protocols use three different antibiotics all together or in a pulsing pattern.

I looked on the PHAC website just last night for any treatment advice for late Lyme disease, and in its “for physicians” section, it linked me only to a 2006 article of treatment protocols. Those old protocols use only one antibiotic by itself for only two to four weeks, even when the brain is affected. We need PHAC to acknowledge the updated 2014 ILADS guidelines and formally post this most up-to-date information for physicians on their website so that doctors can manage their patients appropriately.

In summary, priorities for funding must align with the priorities of people affected by Lyme disease and their experts. The top two priorities would be diagnosis and management related. For diagnosis, we must evaluate the use of a more sensitive yet still specific diagnostic test such as the ELISpot, and make it available to Canadians immediately as a part of that evaluation. For management, Canadian clinical practice guidelines must consider the most up-to-date research and meet Institute of Medicine standards.

We must do broad education for physicians in all specialties and in general practice. We also need to train up a cohort of physicians with special expertise in the treatment of people with chronic manifestations of Lyme disease. Physician expert engagement must include the College of Family Physicians of Canada, which has a mandate to provide holistic patient-centred care. Family doctors are the ones on the front lines, from diagnosing initial infection to caring for complex systemic diseases.

Finally, it is very important that patients be an integral part of the research direction and research network.

Thank you for your attention today.

[The Chair, Liberal, Bill Casey]

Thank you to all of you for your contributions here. We're all learning a lot in a very short time.

We're going to go to our question period now. We'll have a seven-minute round of questions, starting with Ms. Sidhu.

[Sonia Sidhu, Liberal, Brampton South, ON]

Thank you, Mr. Chair.

Thank you to all of the presenters for their valuable testimony.

My question is for Dr. Hawkins and Dr. Zubek.

This week we heard from patients that physicians need more training and need to properly handle this disease, as you also said in your testimony. What kind of education awareness do you want to see that has not been incorporated in the framework?

[Dr. Elizabeth Zubek]

My feeling on that is that we need to publish the ILADS guidelines because they tell physicians that patient preference is important: here's the evidence; how long do we want to treat for; what are the options. Physicians can look at the research and at the patient preference for treatment. These evidence-based guidelines are a very valuable tool for physicians to have access to.

The second thing I mentioned was developing a cohort of physicians where people like Ralph and me and the very small group of us who treat chronic infections can train a larger cohort to spread that knowledge further in Canada.

[Sonia Sidhu, Liberal, Brampton South, ON]

Thank you.

Dr. Hawkins, can you point out any research that has not been incorporated in the framework?

[Dr. Ralph Hawkins]

A really short answer to that question is yes.

[Sonia Sidhu, Liberal, Brampton South, ON]

What do you want to see?

[Dr. Ralph Hawkins]

I would like to see included in the framework the literature from Dr. Samuel Donta, for example, that addresses cohorts of patients who have received longer duration treatments with oral antibiotic therapies with outcomes that have been really quite satisfactory. This is not addressed in the framework.

I accept what Dr. Njoo is saying, that the framework doesn't specifically address treatment guidelines. Whether it should address treatment guidelines is a different question. I think it should, but I accept that he is telling us that it doesn't.

There is an abundance of literature. I have a personal library of well over 1,000 reference papers on Lyme disease that address various aspects of the disease that are not covered in various ways by the IDSA approach to Lyme disease and are certainly not addressed by the framework document in front of you.

[Sonia Sidhu, Liberal, Brampton South, ON]

Okay.

My next question is for Canadian Blood Services. I want to clarify a point that was brought out during the last meeting on the subject. Some witnesses claim that they contracted or transmitted Lyme disease through pregnancy. However, the CDC claim “there is no evidence that [the] disease is transmitted from person-to-person.”

Can you comment on the validity of CDC findings in reference to the transmission of Lyme disease?

[Dr. Margaret Fearon]

I can't really comment on transmission through pregnancy. That would be better addressed by Howard.