The role of patient advocates in Lyme disease policy should be limited


This article has been closed to comments. 25 comments

  1. Kim

    “It is imperative to consider the burden that Lyme disease has, and will have, in relation to other public health threats in Canada when developing the Federal Framework, given the relatively small portion of the population affected by Lyme disease (less than 1%) and the increasing importance of antibiotic stewardship.”

    You seem to be missing a lot of important information in your post including; Unreliable testing (Health Canada 2012), numerous strains of the Lyme bacteria in Canada–not just the one they test for, unreported cases and suspected cases. All of those certainly play a large role in inaccurate reporting of Lyme cases in Canada. I’m surprised that information isn’t posted since you attended the conference.

    “The Federal Framework should focus on incentivizing research targeted at better understanding the disease, as well as educating medical professionals and Canadians about prevention and identification of Lyme disease.”

    What? That is exactly its purpose which is posted on the federal government web site.

    “The conference’s aim was to develop a framework that will help prevent and reduce Lyme disease-related health risks to Canadians. It focused on:

    medical surveillance for tracking:
    incidence rates
    associated economic costs
    guidelines and best practices regarding:
    treatment
    prevention
    identification
    management
    standardized educational materials:
    to increase national awareness
    for use by Canadian public health providers”

    • Jennifer Drury

      YES! Lawyers now….lawyers will decide what is best for Lyme patients. What is this world coming to? Unbelievable.

  2. Debra Fraleigh (member of Ontario Lyme Alliance)

    Why Patients and Patient Advocates Need to be Equal Partners in the Development of Lyme disease Policy

    It appears that Melanie McPhail and Jacob Shelley do not understand the depth of the controversy surrounding Lyme disease, nor what has engendered it. They need to realize that there would not be any controversy surrounding Lyme disease if current management practices were efficacious in ensuring all patients are properly diagnosed and treated effectively so that patients are returned to their pre-Lyme health status. The controversy is a direct result of the failure of these management practices which has resulted in genuine patient suffering.

    Historically, patients have had no role in determining Lyme disease policy much to the detriment of public health and society. From the time the cause of Lyme disease was identified in 1982 up until very recently mainstream medicine has dictated that Lyme was restricted to having a limited regional distribution affecting small numbers of people. The symptoms have often been described as minimal, presenting predominantly with a specific bull’s-eye rash, some flu-like symptoms, then later with transitory, recurring but mostly self-resolving symptoms. As well as not being viewed as a ‘serious’ disease, it was believed that Lyme disease was “hard to catch and easy to cure”. Over the years (and more particularly since 2008) new information has shown that none of these premises are valid.

    McPhail and Shelley have aptly pointed out that there are still many unknowns about Lyme disease. However, because Infectious Diseases Society of America (IDSA) Lyme policy, ideological position and messaging continues to imply that all of the important questions with regard to this complex disease have already been answered, there has been little incentive to do further research and no reason for funding to be provided for novel and innovative studies that will advance the science.

    In Canada, we currently have an opportunity to develop an integrated comprehensive Framework to provide a foundation to direct actions which could potentially prevent the pitfalls that have characterized the history and ongoing legacy of Lyme disease management in the United States. There, we continue to see increasing numbers of spreading endemic areas becoming epidemic and needless patient suffering. Similar to the situation in the United States, maintaining the status quo with regard to Lyme disease policy will only serve to ensure that many more Canadian residents will receive inadequate medical care and increasing numbers of patients will suffer from the long-term debilitating symptoms of late-stage Lyme disease.

    Scientists for the Public Health Agency of Canada have estimated that by 2020 approximately 80% of people in Eastern Canada will be living in areas that are endemic for blacklegged ticks.(1) By 2025, they estimate that these areas will further be endemic for Lyme disease.(2) At the Canadian Public Health Association conference in May 2014, Dr. Michel Deilgat, an advisor to the Public Health Agency of Canada, presented an even more disturbing forecast. With regard to reported case incidence for Lyme disease across Canada, he announced, “By 2020, an incidence rate of up to 18,000 cases a year is projected.” (3)

    Contrary to some “personal view” opinion articles written by biased IDSA members as part of an advocacy campaign that tries to discredit any opposing views and which attempt to portray all advocates who seek change for the way Lyme disease is managed as being “antiscience”, patients generally realize that the only useful solutions for themselves, others and future generations will be provided with additional studies. We need new avenues of research, open scientific debate and improved understanding, education and communications about tick-borne diseases. We also critically need robust evidence-based data to understand the complexities of tick-borne diseases and to guide diagnoses and treatment options, instead of “expert” opinion as provided by at least 54% of the 2006 IDSA Lyme guidelines.

    Melanie McPhail and Jacob Shelley assert that, “the general public is not as adept as experts at assessing risks of treatment or critically assessing scientific research.” I think they would be surprised to learn that the Institute of Medicine’s (IOM) standards for generating trustworthy guidelines(4) stand in contrast to their opinion. Standard 3 of the IOM publication states, “The GDG should be multidisciplinary and balanced, comprising a variety of methodological experts and clinicians, and populations expected to be affected by the CPG. Patient and public involvement should be facilitated by including (at least at the time of clinical question formulation and draft CPG review) a current or former patient and a patient advocate or patient/consumer organization representative in the GDG. Strategies to increase effective participation of patient and consumer representatives, including training in appraisal of evidence, should be adopted by GDGs.” Clearly the IOM believes that patients have the capacity to develop these skills when they do not already have them. In addition to other valuable knowledge that the patients bring to the table, patients are best positioned to identify treatment priorities. Ultimately, patients are the ones who have to live with the end-result of treatment so they should be the ones to define success, failure and reasonable risk.

    Since Melanie McPhail and Jacob Shelley both attended the Federal Framework on Lyme Disease Conference, they should have developed some understanding of the extreme heterogeneity of the patient population. Patients come from all walks of life with a variety of experiences and perspectives. Despite this diversity, most patients (including myself), are firm believers in the principles of evidence-based medicine (EBM), as clarified by David Sackett and colleagues in 1996.(5) Evidence-based medicine applies population-based data to the care of an individual patient, while respecting the fact that practitioners have clinical expertise reflected in effective and efficient diagnosis and thoughtful identification and compassionate use of individual patients’ predicaments, rights, and preferences. Patients (who do believe in EBM) want to ensure that all the contentious and controversial questions (including future research needs) are put on the table for discussion and that all the most up-to-date scientific findings are included in the deliberations. Curtailing patient participation in the development of Lyme policy, will only serve to maintain the historical legacy of bias in the selection and evaluation of scientific evidence as well as the status quo for Lyme disease management. Curtailing patient participation will exacerbate and deepen the controversy.

    Patients and patient advocates need to be equal partners in the development of Lyme disease policy to ensure that our interests and concerns and those of the public are adequately represented. Being equal partners implies working together collaboratively. It would mean having shared duties and responsibilities for making sure that the Federal Framework on Lyme disease (and any resulting guidelines) address all of the important questions with an outlook towards providing practicable solutions that will be considered reliable and trustworthy by everyone in Canada, all of whom will have a stake in the outcome. The need to be equal partners is not about voices of patients trumping other voices at the table. Patients and patient advocates need to ensure that all of the rather limited evidence-based science that does exist (and all that will be undertaken) will be critically evaluated for its deficiencies and its merits in determining health policy.

    If the Federal Framework is to be truly productive, all stakeholders will need to operate on a basis of sincere intent with the expectation that through sharing perspectives, resolutions to the complex problems that Lyme presents can be obtained.

    Transparency and open debate are essential first steps to improving the management of Lyme disease to optimize prevention strategies and patient outcomes. They are also needed to begin resolving some of the controversial issues and moving the science forward. However, a collaborative partnership founded through the development of the Federal Framework which could then evolve to work towards a broader integrated strategy to address tick-borne diseases will likely be the key to finding genuine solutions that will ultimately improve peoples lives, ensure public health and its sustainability, enhance knowledge and advance the science.

    1. Leighton, P. A., Koffi, J. K., Pelcat, Y., Lindsay, L. R. and Ogden, N. H. (2012), Predicting the speed of tick invasion: an empirical model of range expansion for the Lyme disease vector Ixodes scapularis in Canada. Journal of Applied Ecology, 49: 457–464.
    http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2664.2012.02112.x/abstract

    2. Ogden, N.H., Lindsay, L.R. and Leighton, P.A. (2013), Predicting the rate of invasion of the agent of Lyme disease Borrelia burgdorferi. Journal of Applied Ecology, 50: 510-518
    http://onlinelibrary.wiley.com/doi/10.1111/1365-2664.12050/abstract

    3. Canadian Public Health Association Conference May 2014 Abstracts. The Emergence of a Tick-borne Infectious Disease: Lyme Disease in Canada. Page 123. (page 125 of PDF)
    http://www.cpha.ca/uploads/confs/2014/abstract-program.pdf

    4. The Institute of Medicine of the National Academies (IOM). Clinical Practice Guidelines We Can Trust – Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs)
    http://www.nationalacademies.org/hmd/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust.aspx

    5. Sackett David L, Rosenberg William M C, Gray J A Muir, Haynes R Brian, Richardson W Scott. Evidence based medicine: what it is and what it isn’t. BMJ 1996; 312:71.
    http://www.bmj.com/content/312/7023/71

    • Michele Hogg

      Very well written and articulated Debra Fraleigh! I am curious to know where McPhail & Shelly obtained the statistic that “Lyme Disease only affects 1% of Canada’s population.” Obviously they were absent during the discussions regarding the fact that cases of Lyme disease have been severely under reported in Canada. They also seem to have missed the facts that, Canadian testing is extremely inaccurate and Lyme should be a clinical diagnosis which may be backed up by the development of reliable test methods. Finally, the authors seem to have missed the point that much of the research on Chronic or Late Stage Lyme has never made it into “Peer Reviewed Medical Journals” due to the fact that the CDC and the IDSA have denied the existence of all facets of Lyme except for the Acute Stage where the EM rash ( only 20% of patients) is present and the patient is experiencing “flu-like symptoms.” Even when these symptoms are present, Drs. will dismiss the probability of Lyme disease if the patient does not recall the tick bite, does not reside nor have they visited an endemic area or the tick was not engorged in the body for 24-48 hrs. As a 50 year Veteran of Lyme I will be very dismayed if patients and advocates are not included in the development of the Federal Framework process.

    • Jennifer Drury

      BRAVO!

  3. CL

    http://canlyme.com/2012/08/14/british-columbia-government-report-on-lyme-disease-schmidt-report/
    Please read this and tell us why it was buried until a Freedom of Information Request brought it forth.

    Maybe if those of use who are extremely ill (Oh, it is in our heads? NOT) hadn’t been shut out and abused for so long, we wouldn’t have had to resort to activism/government intervention to get the care we need. Understandably, there is contention on *both* sides, and yes, there is some concern on *both* sides that the ‘science’ is not credible. Locking patients out of the process has led to this mess, so locking them out further vs finding the middle ground is just the Old Guard asserting power and in my opinion leads to further medical and human rights abuses.

  4. Luba N Williams, Founder worldlymeday.org

    I love how you so arrogantly underline : given the relatively small portion of the population affected by Lyme disease (less than 1%)
    Where do you get this statistical figure from ? It’s incorrect. What do you know about the 300 strains of borrelia untested for and the one that is tested for is by using an inaccurate test. You forgot to mention how many people are misdiagnosed with stroke, heart disease, Multiple Sclerosis, ALS, Lupus, Rheumatoid Arthritis, Fibromyalgia, Chronic Fatigue Syndrome, Anxiety , Bipolar, Mononucleosis, . . . . You see it’s your type of ignorance that festers within a boil of infection allowing it to grow. You haven’t a clue what you are speaking about, so interjecting your negative opinion without knowing appropriate facts is irrelevant. The entire article has a very nasty tone to it, directed at whom ? Those battling with disease that can kill them, that is disabling them. So before you throw statistics around, let me tell you there ARE NO ACCURATE statistics for Lyme disease because there is no accurate test and doctors are misdiagnosing patients daily. There are tens of thousands of people in Canada going without care right now, and some of them are dying. Do you wish to be a part of that change or to make it worse? Those suffering with the disease have years, sometimes decades of knowledge which far outweigh anything you could learn. I refer you and others including PHAC to the foremost leader in Lyme disease training and education. ILADS The International Lyme and Associated Diseases Society of America http://www.ilads.org and to Dr. Ernie Murakami, of the Murakami Centre For Lyme Disease Research and Education murakamicentreforlyme.org based out of British Columbia.

    • Jennifer Drury

      Great comment.

  5. Lucy Barnes

    If Camp A was right, there wouldn’t be a Camp B.

  6. Jim Wilson

    Public Health Law… therein lies the problem with this commentary. Our ‘Health Law Institutes’ have bound the hands of patients and physicians within our system for years. They are not ‘public’ health law, they are ‘industry’ health law driven and nothing else. This is an area of public tax dollar funding via our universities that needs to be seriously reexamined.

    This statement, “Jim Wilson, President of the Canadian Lyme Disease Foundation and a Conference co-chair, called for patients to be treated as equal partners in the development of Lyme disease policy.” is a misrepresentation of my, Jim Wilson’s, consistent position. I have always stated that “patients, and their experts” be seen as equal partners, not patients alone. Patients are a very diverse group including lawyers, doctors, microbiologists, geneticists, plumbers, truck drivers, and hair dressers. How dare a self proclaimed group of alleged experts be given authority over the sick while excluding the sick and their experts.

    Here is another telltale quote from this article, “We think, however, that the influence of patient groups on scientific policy needs to be more clearly defined and curtailed.”

    Of course patient’s and their experts pose a threat, to dogmatic policy that has not faced the requirements of rigorous scientific debate. ‘Curtailing’ the input of the victims and their experts is reminiscent of many failed states who have used victims as research subjects. One only has to be reminded of the second world war.

    This article cites the same old poorly designed research to qualify the author’s position, and that has been drawn into question by real scientists for over a decade.

    Author’s McPhail and Jacobs avoid some very obvious questions, for example, why are borrelia bacteria showing up in such huge percentages in Alzheimer’s disease and multiple sclerosis if borreliosis (Lyme disease) is such an non-issue? What is the science behind the evidence?

    Why has Canada failed to fund human tissue study using today’s sophisticated DNA sequencing technology studying all those diseases linked to Lyme borreliosis? Why has all research funded to date by our tax dollars done nothing to address the prevalence of borrelia in the human population, and in fact much of it has been used to support dogma?

    These two authors state with confidence that Lyme disease is a less than 1% of the population issue yet they provide no evidence to support it… though, even 1% represents at a minimum 350,000 people.

    I suggest each reader of my comments go to CanLyme.com and using our search string feature access many of the thousands of research papers. Lyme disease is caused by a spirochaetal bacteria. At CanLyme, type in the words multiple sclerosis (MS), Alzhiemers, etc. You will find research going back to at least 1911 in which they were well aware of spirochaetal bacteria in the cerebral spinal fluid of MS patients. You can access a 1957 Times magazine article in which the physician names the spirochaete… then, all that evidence disappeared and MS magically became an autoimmune disease for which there was no cure, only disease management by expensive drugs. Are all MS cases actually Lyme disease, not likely at all. But how many are?

    Also, go to http://www.pubmed.com, the US government research archive and simply type in Lyme, borrelia, or borreliosis, and any of the major organ complications such as liver, kidney, heart, joint,ocular,brain, and on and on.

    Jim Wilson,
    President,
    Canadian Lyme Disease Foundation
    http://www.canlyme.com

  7. Kenneth B. Liegner. M.D.

    Much that is proffered as ‘evidence-based’ in Lyme disease is pure dogma and circular reasoning shutting out extensive evidence developed by inummerable scientists in worldwide published peer-reviewed literature on persistence of infection, serovariability and enormous complexity. Simplistic ‘authority-based’ ideology impedes progress in this field. We’re it not for the pressure of patient-advocates, tens of thousands of deaths due to HIV/AIDS would have continued unabated. The claim of ‘small’ numbers of borrelia-affected persons in Canada is unverifiable given the absence of the disease in the differential diagnosis of many physicians in Canada and elsewhere and the crude diagnostics available, compounded by the fatally flawed two-tier algorithm promoted by the U.S CDC.
    Kenneth B. Liegner, M.D., Pawling, New York, U.S.A.

    • CL ( Caroline Lennox )

      thank you for articulating the situation so well

    • Jennifer Drury

      An American MD gets it….wow….no wonder we Canadians travel south to get treatment….so sad.

  8. CL ( Caroline Lennox )

    Lyme Literate MD’s were NOT invited to a pre-conference “invitation only” “Symposium” at Queens University. Our tax dollars are being squandered by the Old Guard desperately seeking to maintain their grip and protect their positions.

    When the “experts” such as Hatchett and Bowie admitted they did not know the US CDC’s case definition of Lyme Disease, which is based on potentially fraudulent research, they lost any rights to declare themselves as “experts”.
    Dr Bowie said, post-conference that none of “these” (who?) people have had Lyme Disease. They have never had Lyme Disease”. On what “evidence-based” grounds did he make such a judgement on patients he has never seen files on?

    We are not asking to have all the control. We are asking to have a seat ar the table when it comes to evaluating “science” and having a say in what is decided to be called “evidence-based” vs letting the Old Guard cherry pick only that which supports their pre-existing, biased beliefs. We have credible experts, many with medical backgrounds and decades of research, who are being shut out of this process, simply because they are challenging the status quo.

    I invite you to research how and why the case definition was changed in 1994 based on what is known as “Dearborn”. You will be shocked and might even change your views. Perhaps even write your thesis on it!

  9. CL ( Caroline Lennox )

    I would like to know if the authors directly or indirectly received funding to attend the conference, or to do their research, or to write this opinion piece, and if so from where?

    • Katlo

      Very good point. Your question needs to be answered.

  10. lou overman

    If the so-called medical authorities are afraid of patient input, then something is very wrong here.

  11. Jacqueline Charron-Chapman

    I certainly do not know everything about Lyme, but I do know there are families out there with several people in the same family sick with Lyme. Their kids have it, they have and their spouses have it. It is writings like this that just turns the already painful knife of Lyme deeper and deeper. It doesn’t help anyone.

  12. Jennifer Drury

    “This has occurred despite a lack of credible evidence that long-term antibiotic courses are helpful, and even in the face of the recognized risks of resistance involved with unnecessary antibiotic treatment.”
    “…given the relatively small portion of the population affected by Lyme disease (less than 1%)”
    I wonder where, law graduate, you get your statistics or information. I know zero Lyme patients who felt better after 4 weeks antibiotics and at least 17 patients who feel almost “cured” after years of treatment. I live in a village basically and 6 of us have Lyme disease.
    If we are to educate, we must do it in a enlightened and smart manner. Anyone can say anything.

  13. Jennifer Kravis

    Ms McPhail and Mr. Shelley – I am also a lawyer, who was a partner at one of Canada’s top law firms. I was forced onto disability leave, after falling severely ill at age 36 with a “mysterious” illness, leading to a diagnosis of fibromyalgia and chronic fatigue syndrome. It took 6 years to be properly diagnosed and treated for Lyme Disease, at great personal expense and outside this country. If you want to put your skills to good use, I would urge you to dig a bit deeper into this “controversy” and actually expose the ugly underbelly of doctors, scientists and government medical authorities who have significant conflicts of interest and incentive to deny, diminish and under report this hideous epidemic. As always, if you wish to understand why people behave the way they do.. follow the money. I recommend starting by watching the documentary Under Our Skin and it’s sequel Emergence, and then start to actually look at the multitude of scientific studies that exist in support of chronic Lyme disease. It is far too easy for you to take the well orchestrated, but completely untrue, campaign statements at face value, when in fact the real story is much more complicated, but much more interesting.

    • Elaine

      Thank you for your comment Jennifer. We need more people like you who understand what is involved with Lyme disease.

      • Amalfe Konarzycki

        Thank you!

  14. Steven Shumak

    Looks like everyone agrees: the study (and management) of Lyme Disease must be evidence-based. The problem, of course, is what constitutes evidence. Alas, despite its appeal and persuasive power, anecdote does not.

    Most of the commenters here would have us believe that Lyme is hugely undiagnosed and inadequately treated. Unfortunately, the data does not justify those assertions. Personal stories are not data, nor are diagnoses made on the basis of what is, effectively, anecdotal evidence, i.e. non-standard, clinical-only diagnoses of Lyme. Moreover, lab results that are often presented in support of the notion of ‘chronic Lyme’ and the need for its protracted antibiotic treatment are, once again, effectively anecdotes given that they are based on non-standard laboratory diagnostics and criteria.

    Kudos to McPhail and Shelley for reminding us of the need for using evidence – real evidence, not anecdote, opinion, or agenda – when determining policy for the study and management of Lyme Disease.

  15. Donna Lugar

    I was once told that there is a lag time between emerging diseases and the science-based medicine required to properly diagnose and treat. I was also told that it generally takes 20-25 years for the science to drill down to the Doctors.

    As someone that was clinically diagnosed with tick borne diseases in 2011, I started to do whatever I could to ensure that the “lag time” and the wait time are decreased. That includes a considerable amount of research of existing evidence-based science and peer-reviewed evidence. I even have a Facebook group dedicated entirely to research that I have come across from all over the world and I try to ensure that any new research gets to a large group of people.

    There are hundreds, probably thousands of people just like me doing research – DAILY. Many of those people are Doctors, Nurses, Lawyers, Dentists, Microbiologists, Biologists, Entomologists, etc., etc., etc., that, for whatever reason, have a vested interest in also ensuring the “lag time” is reduced.

    I think harnessing that research knowledge would be beneficial to everyone. Much of the research is already there. Much more needs to be done. Who knows that better than people, such as myself, that have spent hours, days, weeks, months and even years, of their lives trying to find answers!

    Many of us want to help! Many of us NEED to help! Hopefully how that plays out will be beneficial to all.

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