The CLSA submitted the following brief to the The Standing Committee on Social Policy regarding their review of Bill 27, An Act to require a provincial framework and action plan concerning vector-borne and zoonotic diseases.
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June 1, 2015
Summary:
The Canadian Lyme Science Alliance (CLSA), representing both academic researchers and clinical practitioners, is dedicated to enhancing our understanding of Lyme disease, and ensuring that health policy accurately reflects available scientific data. We suggest the following amendments to Bill 27, as explained in more detail below.
Brief:
On behalf of the Canadian Lyme Science Alliance (CLSA), we are pleased to provide feedback regarding Bill 27, An Act to require a provincial framework and action plan concerning vector-borne and zoonotic diseases, on the occasion of its June 1st public hearing before The Standing Committee on Social Policy. We wish to comment on the Bill particularly as it applies to Lyme disease.
Lyme borreliosis is a dangerous and debilitating bacterial disease transmitted through the bite of a tick vector. It occurs in multiple stages, with the first being characterized by localized infection at the site of tick attachment, that may be accompanied by an erythema migrans (EM) skin rash and flu-like symptoms. If untreated, the bacteria can spread throughout the body, giving rise to cardiac, musculoskeletal, and / or neurological manifestations (1).
Overall, Lyme is a complex and incompletely characterized disease that is further confounded by controversy and highly polarized debate. The fate of both the bacteria and the patient in cases of longstanding infection (often termed Chronic Lyme Disease [CLD]), and the potential failure of antibiotic treatment to resolve symptoms (commonly referred to as Post Treatment Lyme Disease Syndrome, [PTLDS]) are hotly contested by medical professionals. Presently in Ontario, as in the rest of the country, there is no consensus on the definition, diagnosis, or management of these conditions. Yet, there is evidence that incidence of borreliosis is increasing in Canada, and is likely under-reported (2), making Lyme disease a high priority area of investigation.
The CLSA is a fledgling national organization that unites academics and clinicians in the quest for a more comprehensive understanding of Lyme disease. It was founded by Canadian research scientists out of concern for the schism in medical literature and guidelines that currently divides scientists, clinicians, policymakers, and patients. We represent the voice of independent researchers and practitioners who call for an open, unbiased, and rigorous scientific dialogue surrounding Lyme borreliosis.
In principle, we strongly support efforts to improve surveillance, testing, and treatment of Lyme disease in Ontario, as well as initiatives that prioritize research in this field. However, we urge that the process of policy and guideline creation should be undertaken in the spirit of ethical scholarship and evidence-based medicine. We also strongly caution against adopting international guidelines without a thorough, transparent, and independent review of all available scientific literature.
Earlier this year, the CLSA issued a statement to the Infectious Diseases Society of America (IDSA) as it endeavours to revise its Lyme disease guidelines. We argue that their proposed methodology does not constitute a best-practice approach to healthcare. Notably, the guideline authorship panel was deemed to lack diversity, as there is a strong clinical presence but marked deficit of basic researchers in relevant disciplines. Likewise, there is minimal representation from the community of scholars and practitioners who have published evidence supporting CLD or PTLDS - two of the most contentious and challenging aspects of this illness. Furthermore, the inclusion of a single ‘consumer representative’ with no disclosed knowledge of or experience with Lyme disease violates the Institute of Medicine (IOM) Standards for Developing Trustworthy Clinical Practice Guidelines, which call for “a current or former patient AND a patient advocate or patient/consumer organization representative” (3).
Part of the mandate of the CLSA is to ensure that no published, peer-reviewed science is dismissed without scrutiny, and likewise, that existing protocols and international guidelines are not accepted or implemented unquestioningly.
To this end, we have an active petition, currently generating support from the academic and clinical sectors, that requests several deliverables from the task force representing the Federal Framework on Lyme Disease (Bill C-442). Goals include involving patients and advocates in the process of policy development, undertaking a transparent review of available literature to generate solid, evidence-based guidelines, allocating resources to Canadian researchers to address deficits in the literature and identify uniquely Canadian perspectives on Lyme disease, and finally, ensuring that the Lyme disease dialogue remains open as new research becomes available. (Details available at www.lymesciencealliance.org)
We suggest that these objectives are broadly applicable to any contemporary initiatives to address Lyme disease. Thus, we recommend that Bill 27 be amended to specify:
We would be pleased to endorse a Bill that incorporates these suggestions. We also invite your questions, comments, and requests for consultation, and would be delighted to apprise you of the support generated from Canada’s scientific and clinical communities for a fair and rigorous scientific inquiry into the complexities of Lyme disease.
We look forward to continued dialogue.
Sincerely,
Ms. Melanie K. B. Wills Dr. Vett K. Lloyd
Co-founder, CLSA Co-founder, CLSA
Ph.D. Candidate, Ph.D., Professor
Molecular and Cellular Biology Department of Biology
University of Guelph Mount Allison University
Select References
1. Borchers AT, Keen CL, Huntley AC, Gershwin ME. 2015. Lyme disease: A rigorous review of diagnostic criteria and treatment. J. Autoimmun. 57:82–115.
2. Sperling J, Middelveen M, Klein D, Sperling F. 2012. Evolving perspectives on lyme borreliosis in Canada. Open Neurol. J. 6:94–103.
3. Institute of Medicine. Standards for Developing Trustworthy Clinical Practice Guidelines. Mar 23, 2011; Available at: http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust/Standards.aspx [Accessed April 7, 2015].
4. Canadian Institutes of Health Research. Strategy for Patient-Oriented Research - Patient Engagement Framework. July 2 2014; Available at: http://www.cihr-irsc.gc.ca/e/48413.html [Accessed April 25, 2015].
__
June 1, 2015
Summary:
The Canadian Lyme Science Alliance (CLSA), representing both academic researchers and clinical practitioners, is dedicated to enhancing our understanding of Lyme disease, and ensuring that health policy accurately reflects available scientific data. We suggest the following amendments to Bill 27, as explained in more detail below.
- Inclusion of patients in the process of guideline development.
- Consultation of independent experts.
- Generation of a report summarizing the methods and literature used to establish Lyme disease surveillance, testing, and treatment protocols.
Brief:
On behalf of the Canadian Lyme Science Alliance (CLSA), we are pleased to provide feedback regarding Bill 27, An Act to require a provincial framework and action plan concerning vector-borne and zoonotic diseases, on the occasion of its June 1st public hearing before The Standing Committee on Social Policy. We wish to comment on the Bill particularly as it applies to Lyme disease.
Lyme borreliosis is a dangerous and debilitating bacterial disease transmitted through the bite of a tick vector. It occurs in multiple stages, with the first being characterized by localized infection at the site of tick attachment, that may be accompanied by an erythema migrans (EM) skin rash and flu-like symptoms. If untreated, the bacteria can spread throughout the body, giving rise to cardiac, musculoskeletal, and / or neurological manifestations (1).
Overall, Lyme is a complex and incompletely characterized disease that is further confounded by controversy and highly polarized debate. The fate of both the bacteria and the patient in cases of longstanding infection (often termed Chronic Lyme Disease [CLD]), and the potential failure of antibiotic treatment to resolve symptoms (commonly referred to as Post Treatment Lyme Disease Syndrome, [PTLDS]) are hotly contested by medical professionals. Presently in Ontario, as in the rest of the country, there is no consensus on the definition, diagnosis, or management of these conditions. Yet, there is evidence that incidence of borreliosis is increasing in Canada, and is likely under-reported (2), making Lyme disease a high priority area of investigation.
The CLSA is a fledgling national organization that unites academics and clinicians in the quest for a more comprehensive understanding of Lyme disease. It was founded by Canadian research scientists out of concern for the schism in medical literature and guidelines that currently divides scientists, clinicians, policymakers, and patients. We represent the voice of independent researchers and practitioners who call for an open, unbiased, and rigorous scientific dialogue surrounding Lyme borreliosis.
In principle, we strongly support efforts to improve surveillance, testing, and treatment of Lyme disease in Ontario, as well as initiatives that prioritize research in this field. However, we urge that the process of policy and guideline creation should be undertaken in the spirit of ethical scholarship and evidence-based medicine. We also strongly caution against adopting international guidelines without a thorough, transparent, and independent review of all available scientific literature.
Earlier this year, the CLSA issued a statement to the Infectious Diseases Society of America (IDSA) as it endeavours to revise its Lyme disease guidelines. We argue that their proposed methodology does not constitute a best-practice approach to healthcare. Notably, the guideline authorship panel was deemed to lack diversity, as there is a strong clinical presence but marked deficit of basic researchers in relevant disciplines. Likewise, there is minimal representation from the community of scholars and practitioners who have published evidence supporting CLD or PTLDS - two of the most contentious and challenging aspects of this illness. Furthermore, the inclusion of a single ‘consumer representative’ with no disclosed knowledge of or experience with Lyme disease violates the Institute of Medicine (IOM) Standards for Developing Trustworthy Clinical Practice Guidelines, which call for “a current or former patient AND a patient advocate or patient/consumer organization representative” (3).
Part of the mandate of the CLSA is to ensure that no published, peer-reviewed science is dismissed without scrutiny, and likewise, that existing protocols and international guidelines are not accepted or implemented unquestioningly.
To this end, we have an active petition, currently generating support from the academic and clinical sectors, that requests several deliverables from the task force representing the Federal Framework on Lyme Disease (Bill C-442). Goals include involving patients and advocates in the process of policy development, undertaking a transparent review of available literature to generate solid, evidence-based guidelines, allocating resources to Canadian researchers to address deficits in the literature and identify uniquely Canadian perspectives on Lyme disease, and finally, ensuring that the Lyme disease dialogue remains open as new research becomes available. (Details available at www.lymesciencealliance.org)
We suggest that these objectives are broadly applicable to any contemporary initiatives to address Lyme disease. Thus, we recommend that Bill 27 be amended to specify:
- The inclusion of patients and / or advocacy group representatives in the process of guideline creation, as outlined by The Canadian Institutes of Health Research (CIHR) Strategy for Patient-Oriented Research (SPOR) (4).
- The consultation of relevant, independent experts (researchers and clinicians) who can critically assess biomedical literature and determine the suitability of current and proposed techniques for evaluating and treating Lyme disease.
- The generation of a publically available report summarizing the methods used by the guideline authors to arrive at their recommendations. This should include a critique of the scientific literature utilized, and provide justification in the event that any perspective supported by peer-reviewed science is dismissed and not addressed in the resulting surveillance, diagnostic, or therapeutic strategy.
We would be pleased to endorse a Bill that incorporates these suggestions. We also invite your questions, comments, and requests for consultation, and would be delighted to apprise you of the support generated from Canada’s scientific and clinical communities for a fair and rigorous scientific inquiry into the complexities of Lyme disease.
We look forward to continued dialogue.
Sincerely,
Ms. Melanie K. B. Wills Dr. Vett K. Lloyd
Co-founder, CLSA Co-founder, CLSA
Ph.D. Candidate, Ph.D., Professor
Molecular and Cellular Biology Department of Biology
University of Guelph Mount Allison University
Select References
1. Borchers AT, Keen CL, Huntley AC, Gershwin ME. 2015. Lyme disease: A rigorous review of diagnostic criteria and treatment. J. Autoimmun. 57:82–115.
2. Sperling J, Middelveen M, Klein D, Sperling F. 2012. Evolving perspectives on lyme borreliosis in Canada. Open Neurol. J. 6:94–103.
3. Institute of Medicine. Standards for Developing Trustworthy Clinical Practice Guidelines. Mar 23, 2011; Available at: http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust/Standards.aspx [Accessed April 7, 2015].
4. Canadian Institutes of Health Research. Strategy for Patient-Oriented Research - Patient Engagement Framework. July 2 2014; Available at: http://www.cihr-irsc.gc.ca/e/48413.html [Accessed April 25, 2015].