The Canadian government recently announced new investment in Lyme disease research. However, Canadian Lyme advocates fear that the patient voice will be excluded from the decision-making process. In the following article, the Canadian Lyme Consortium (CLC)–made up of advocates, patients, researchers and practitioners–offers background and context.

The post reflects the views of its authors, and does not necessarily represent the views of all members of the authors’ organizations.

By Vett Lloyd, PhD; Liz Zubek, MD, CCFP FCFP; Sue Faber and Jennifer Kravis, co-founders, LymeHope; Janet Sperling, CanLyme; Linda Kelso, Ontario Lyme Alliance.

The Canadian Federal Government announced the first major financial investment into Lyme disease research on October 15, 2018 – 4 million dollars designated to support the formation of a Lyme disease research network. Yet the patient community in Canada is not celebrating. Why not?

The answer is that there are a number of very significant problems with how this money is being used to try to control Lyme disease research. The continued exclusion of the Lyme disease patient community from playing more than a token role is the key issue.

Excluding patients from the process

There has been an ongoing narrative in Canada that patients, patient caregivers, advocates, healthcare providers, health researchers and scientists are just being “difficult” when they do not enthusiastically endorse research that is done on patients rather than for patients.

This will sound completely familiar to members of the patient and advocacy community around the world. However, there is hope for the future.

There are, and have been for some time, two research networks in Canada. One, the Canadian Lyme Consortium (CLC), consists of a three-way and equal partnership between the patient community, health care providers and scientists.

The other network, now known as the Canadian Lyme Disease Research Network (CLyDRN), is public health dominated and focused largely on information and prevention messaging. While no one denies the important role of disease prevention, patient advocates are concerned that work on improved diagnostics and on treatment will be ignored.

Endorsing the status quo?

That the CLyDRN includes strong representation from the Association of Medical Microbiology and Infectious Disease Canada (AMMI), which endorses the Lyme treatment guidelines of the Infectious Diseases Society of America (IDSA), further suggests that this group will continue to endorse and enforce the status quo.

The CLyDRN is the network that the Canadian Government has funded to do Lyme disease research. In fact, the CLyDRN was the only network that applied for the $4 million in funding due to the CLC’s early elimination in a preparatory granting stage.

What does “patient engagement” actually mean?

The CLC had submitted a joint application with two leading patient advocacy organizations, only to be informed that its application was disqualified due to the CLC’s close links to the patient community. This occurred not withstanding that patient engagement is a requirement of the of grant application. The definition of the term “patient engagement” turns out to be a critical question – one that challenges tradition and the status quo in both medicine and science.

Problems with the “One-network-to-rule-over-all” approach are outlined below. It is important to note that these problems are not just a laundry list of present and previous grievances. They indicate a serious, systemic and long-standing breakdown in public accountability in Lyme disease surveillance, diagnosis and treatment. This failure comes at the cost of enormous personal suffering and societal cost in escalating health care costs, lost health, lost productivity, and lost lives.

Why tokenism is toxic

The CLyDRN actively promotes its endorsement by 25-40 patients and has mounted an aggressive social media campaign based on the endorsement of a few isolated patients.

This has failed to demonstrate genuine engagement with the patient community to the established Lyme patient support and advocacy groups – with collective nationwide followings of roughly 100,000.

Tokenism is toxic to research into investigation of questions that matter to patients and to the health care professionals who treat patients.

The members of the Lyme disease advocacy community have not, and will not, endorse a process that is not in the best interests of patients, of clinicians treating patients or researchers wanting to do unbiased research on Lyme disease. To do so would mean losing moral integrity and scientific independence.

Patients to “give input” on matters already decided

The CLyDRN is apparently planning a governance structure that allows two patient representatives to have voting rights, according to what had been published on its governance web page before access was denied. (Note: this web page now has been completely removed from the website).

This sounds great. However, as the patient reps will be voting on research plans that have already been developed and which, in fact, are already being rolled out before the reps are in place, patient input will be clearly token.

By the time patients see anything upon which they can express an opinion, the decisions will all have been made. This is not an acceptable model of patient engagement in research.

The importance of good science

The one-network approach promotes poor science. It endorses “group think,” orchestrates control of research funding and chosen research topics, and attempts to control the narrative around Lyme disease in Canada by a small group of public health and infectious disease researchers.

By giving the funding to a network rather than to specific projects, it shelters projects from peer review – funds will be disbursed based on internal decision-making processes which are not transparent or accessible.

Integrity and transparency

The presentation of the lead researchers of the CLyDRN as independent academic researchers in press releases when they are employed by public health agencies or work with public health agencies does little to encourage trust.

The role of public health in mitigating the risk of Lyme disease is not in question. However, efforts to disguise the influence of public health authorities that have demonstrated their leanings to one particular view of Lyme disease are unacceptable.

Uniting the patient community

Despite the very understandable anger that stems from feeling abandoned and betrayed by those entrusted with both the health of the public and of individuals, there is some good that has come from this process.

The Lyme patient community in Canada has become far more united through this process than ever before. The CLyDRN appears to be focused on addressing research from a public health preventative perspective, and while funding for this mandate is important, it is only one narrow aspect within a much larger scope of concern.

Bill C-442

It must be noted that Bill C-442 was presented in Parliament by MP Elizabeth May in June 2012, after a nationwide outcry for improved diagnosis and treatment of people who are already infected by Lyme disease.

The enactment of Bill C-442 into law mandated the development of a federal framework on Lyme disease, and as such, the federal framework is obligated to direct its research endeavours towards the highest priorities identified by the population affected. The mandate of the CLC is to the support the research interests of the patient community and their treating health care providers.

The Lyme disease patient community, of necessity, has achieved a high level of scientific and medical literacy. This makes it an ideal community to partner with in the development of practical and pertinent research endeavours.

Such a partnership will meet guidelines established by the Canadian Medical Association, which has stated that “For patient-relevant research to be meaningful, patient and public engagement in research cannot comprise a token lay person on a research ethics review board. Patients and their caregivers must be involved in decision-making at all steps in the research process, from design to choice of primary and secondary outcomes, through dissemination and implementation.” (CMAJ)

Partnership, yes; tokenism, no

The unique research model embodied by the CLC provides an equal partnership of patients, physicians and researchers in which all groups are involved in every project right from the start – choosing projects, refining the question to be asked, finding resources, performing the study, conveying the results back to the patient and practitioner communities.

Aspects of the CLC structure, such as the “idea hatchery,” are unique but readily transferable to all disease research networks in which full patient engagement is desired.

The idea hatchery is a protected space in which people can propose ideas, others comment on them and where there is engagement from at least one patient, one researcher and one clinician member – one or more of whom is willing to be the project lead –research ideas then move into the implementation phase where resources are acquired and the project initiated. This type of genuine partnership and engagement of patients in research will lead to research that addresses the needs of the Lyme disease community.

History play-by-play

A quick recap for those not familiar with the politics of Canadian Lyme disease research. The story thus far…

In June of 2012, Elizabeth May of the Green Party brought forward a private member’s bill to develop a federal framework on Lyme disease. This bill, Bill C-442, was passed into law in December 2014 after it had received unanimous support in both the House of Commons and the Senate.

Arising from that legislation there was a national research conference in May 2016 that for the first time brought together patients, members of the medical community, public health personnel and researchers to share the lived experiences of Canadians with Lyme disease, and the current understandings of medicine and science.

This information was intended to inform a federal framework on Lyme disease meant to advance prevention, diagnosis and treatment.

This framework was written by the Public Health Agency of Canada (PHAC; Canada’s national public health agency, similar in role to the CDC in the United States).

After a nine-month gestation, the framework was released for 30 days of public input in early February 2017. It was generally received with shock and immense disappointment by the Lyme disease patient community. There was little in the document that reflected the reality of Canadians who are trying to deal with the disease, and the diagnostic and treatment components incorporated little current scientific research.

The final version of the framework differed little from the draft when it was released in May 2017. There was a shared sense of betrayal felt within the Lyme community.

Arising from this framework, however, was the government’s commitment of $4 million for Lyme research in May 2017.

The Canadian Institute of Health Research (CIHR) was charged with the responsibility to disperse the funds with guidance from the Public Health Agency of Canada (PHAC).

It was decided that the funds were to be used to support the formation of one, and only one, Lyme research network in Canada rather than directly funding research.

The CLC in partnership with two well-respected patient organizations, the Canadian Lyme Disease Foundation (CanLyme) and the G. Magnotta Foundation for Vector-borne Diseases, put in a proposal for one of the preliminary planning grants. While there were two such grants available and two applications submitted, only one application was accepted–the one from the group with strong representation and leadership from the public health community and the Association of Medical Microbiologists & Infectious Disease of Canada (AMMI of Canada) which is closely allied with the Infectious Diseases Society of American (IDSA). This group subsequently became the CLyDRN.

The reason given for the rejection of the CLC/patient group proposal was the funding committee’s concern about patients being involved as partners in research.

Given this clear signal that a research network that involved patient groups as equal partners would not be acceptable, the CLC was left with little choice other than to boycott the funding process, leaving the CLyDRN as the only applicant for the $4 million in Lyme disease research funding.

During this time, there were attempts to recruit select CLC researchers because of the CLC’s good relations with the patient and advocacy community to indirectly meet the requirement for patient engagement. When rejected, patient advocacy leaders were then aggressively recruited to endorse the network, but without offering any option to meaningfully engage at the development and decision-making levels.

We are not hopeful that the CLyDRN, based on its erosion of patient confidence, will result in the needed change. However, we would be delighted to be proven wrong and see this substantial financial investment produce the changes that are needed for the Lyme community. In the meantime, the researchers, clinicians and patient advocates of the CLC continue to work, as partners, on patient-identified research goals using national, international and private funding sources.

The Canadian Lyme Consortium is a partnership among researchers, the Lyme disease patient and advocacy community, and healthcare providers. The network was founded to blaze a fresh trail in patient-centered Lyme disease investigation. More info at its website.