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                              TBDWG March 3-4, 2020 - Written Public Comment


    

    

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TBDWG March 3-4, 2020 - Written Public Comment








  
  
    

  
      





*This webpage displays the written comments received by the Tick-Borne Disease Working Group for the March 2020 meeting. The opinions expressed in each comment displayed on this webpage belong solely to the author of the comment and do not necessarily reflect the opinions of the Department of Health and Human Services (HHS) or the Tick-Borne Disease Working Group. Any information provided in the comments displayed on this page has not been verified by HHS.*
Lucy Barnes
To the Federal Tick Borne Disease Working Group,
Tick borne diseases have been shown to create complex health challenges for patients world wide. As the TBDWG continues its important work of developing new policies, my request would be to create a plan to eliminate the repetitive, redundant studies that have hindered our progress and instead focus on developing specific study topics that are more relevant to our needs.  Working toward discovering a cure would be a start in the right direction.
All too often TBD related studies provide bits and pieces of vital information that is subsequently overlooked or forgotten in favor of more futile endeavors. For example, in the 2006 study below it was determined that the presence of spirochetes in organs (mouse model) increased inflammation in sites not typically studied or thought to be related to Lyme disease, such as the lungs, heart, pancreas and kidneys.
With that in mind, appropriate treatment of Lyme disease (to be determined through additional studies), therefore, could potentially prevent patient suffering on a major scale, and would not require a wide range of possibly expensive and pharmaceuticals that would not address the actual source of the problems and would prevent exposing patients to an untold and unnecessary amount of side effects.
Please consider developing and recommending a specific study plan be in place as a model to advance our common goal of finding a cure.  Thank you.
**QUOTE-** “We found that MyD88-deficient mice infected with *B. burgdorferi* did not show increased inflammation at sites typically associated with Lyme disease (joints and heart). However, there was markedly increased inflammation in the muscles, kidneys, pancreas, and lungs of deficient animals.
Cellular thickening of interstitial spaces and perivascular inflammatory infiltrates were also seen. Inflammation of the pancreas was primarily periductal. Inflammation in the lungs showed significantly high perivascular cellular infiltration with thickening of the interstitial space.
Additionally, we have found that inflammation in MyD88-deficient mice occurs in tissues that are not typically affected by *B. burgdorferi* infection, including the lungs, pancreas, kidney, and muscle tissues. **Inflammation in these tissues appears to be directly dependent upon the presence of the spirochete, as tissues that do****not harbor significant numbers of spirochetes, such as the spleen, did not show evidence of inflammation.”**
**SOURCE-***MyD88 Deficiency Results in Tissue-Specific Changes in Cytokine Induction and Inflammation in Interleukin-18-Independent Mice Infected with Borrelia burgdorferi*, Infect Immun. 2006 Mar; 74(3): 1462–1470. [redacted] Link To Article https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1418660/#__ffn_sectitle.
Lucy Barnes, Director
	Lyme Disease Education & Support Groups of Maryland
Mark Eckert
Hello, I am a victim of tick borne infection, it took me 2 years and over dozen a doctors to get diagnosed. Mainstream medicine has failed me.  Since then it has cost me over $60K in out of pocket expenses. I was diagnosed with lyme, bartonella, babesia, ehrlichia, and EBV. As a result I lost my job from the various symptoms, short term disability, and doctor appointments I needed to follow through with to get on top of my health issues.
What is sorely missing is accurate testing to gauge treatment progress.  Currently, there is no effective testing that is bullet proof for both initial and chronic infections.  This is needed yesterday.
	Additionally, what happened to bartonella from the HHS working group?  Countless are infected with bartonella from ticks, there is overwhelming evidence from the various tick labs showing data of infected ticks with bartonella.  Bartonella needs to be included in scope.
	Lastly, research needs to be spent for treatment options for those with chronic infections (lyme, bartonella, etc.). Sick patients have been dismissed for way too long.Resources need to be applied yesterday to the various initiatives in the HHS working group.
Thank you,
	Mark Eckert
	Bethlehem, PA
Mary Anne Kornbau
I have Lyme and three co-infections (bartonella, babesia, erlichia). I was tested for Lyme several times and did not show a positive result until I used IGenX. Why isn’t IGenX the standard in testing for Lyme? It’s much more accurate than the current standard tests. Also, why is the protocol for treating Lyme antibiotics only? Lyme changes into a cyst form that renders it resistant to antibiotics. We need new treatments, new testing, and we need to explore herbal remedies that kill Lyme, ozone and other treatments, and WE NEED OUR HEALTH INSURANCE COMPANIES TO COVER TREATMENTS BEYOND ANTIBIOTICS. THEY DON’T WORK!
Mary Anne Kornbau,
	Lyme patient
Lonnie Marcum
I am a Physical Therapist and health and science writer for the non-profit LymeDisease.org. I’m also a member of the Tick Biology, Ecology and Control Subcommittee.
One of the biggest problems we face today is misinformation—Lyme and tick-borne diseases are no exception. One piece of misinformation I’d like to talk about today is tick attachment time.
Currently, the CDC’s website states: “In most cases, the **tick** must be **attached** for **36 to 48 hours** or more before the Lyme disease bacterium can be transmitted.” Unfortunately, this sends the false message that there is NO risk if any tick is removed within 36 to 48 hours of attachment. This simply IS NOT TRUE! In fact, there are currently no studies showing the minimum attachment time for transmission of Lyme to humans.
One European study documented six cases of culture-confirmed Lyme disease where tick attachment was less than six hours, and another nine cases where transmission occurred in under 24 hours.
While Lyme disease may be the most prevalent tick-borne infection, it is not the only pathogen carried by blacklegged ticks. Borreila mayonii, Anaplasma phagocytomphilum, Borrelia miyamotoi, Ehrlichia musis, Babasia microti and Powassan virus are all transmitted by the same tick that transmits Lyme. And that last one—Powassan—can be transmitted within 15 minutes.
In addition, there are at least nine other tick species in the US known to transmit pathogens to humans, many of them within 24 hours.  Furthermore, many pathogens in the Rickettsia family, like Rocky Mountain spotted fever, can be deadly if not treated within the first week.
Members of the public, as well as many healthcare professionals, are not skilled at identifying ticks or knowing how long they have been attached. Why give the public a false sense of security?
A better message would be to simply inform the public that the chance of disease from infected ticks increases the longer they are attached and feeding. There is no such thing as a 36 to 48 hour grace period. Let’s stop promoting this misinformation.
**References:**
Bernard W. Berger, Dermatologic Manifestations of Lyme Disease, *Reviews of Infectious Diseases*, Volume 11, Issue Supplement_6, September-October 1989, Pages S1475–S1481, [https://doi.org/10.1093/clinids/11.Supplement_6.S1475]
Cook M. J. (2014). Lyme borreliosis: a review of data on transmission time after tick attachment. *International journal of general medicine*, *8*, 1–8. [https://doi.org/10.2147/IJGM.S73791[
Eisen, L. (2018). Pathogen transmission in relation to duration of attachment by *Ixodes scapularis* ticks. *Ticks and Tick-borne Diseases 9*, 535-542. doi: 10.1016/j.ttbdis.2018.01.002
Peavey, CA; Lane, RS (1995) Transmission of Borrelia burgdorferi by Ixodes pacificus nymphs and reservoir competence of deer mice (Peromyscus maniculatus) infected by tick-bite. J Parasitol.  Apr;81(2):175-8. PMID: 7707191
Phyllis Mervine
**CDC should inform the medical community that there are 2 standards of care for Lyme disease**
The single most important thing the Working Group could do right now for the Lyme community and all the patients suffering with Lyme disease is to ask Congress to require the CDC educate the medical community about the two standards of care.
Today, inexplicably, the CDC does not mention or even cite the only current Lyme guidelines, those of the International Lyme and Associated Diseases Society (ILADS), preferring instead to promote the Infectious Diseases Society of America (IDSA) guideline recommendations through surrogates.
For years the CDC promoted and linked only to the IDSA Lyme diagnostic and treatment guidelines, violating its own rules about not taking sides even after new ILADS guidelines were published on the National Guidelines Clearinghouse website, while the IDSA guidelines were delisted for being out of date.
The IDSA guidelines fail many patients and the new guidelines they are currently working on are unlikely to be an improvement for patients. However, many patients improve when their doctors utilize the ILADS guidelines, which allow for individualizing treatment and clinical judgment. The CDC should inform the medical community that there are two standards of care. By taking this simple step, the CDC could save lives.
Below I provide the abstract of the ILADS guidelines with a link to the full journal publication.
**Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease. Expert review of Anti-Infective Therapy.**Cameron DJ, Johnson LB, Maloney EL. 2014 Sep;12(9):1103-35.
Evidence-based guidelines for the management of patients with Lyme disease were developed by the International Lyme and Associated Diseases Society (ILADS). The guidelines address three clinical questions – the usefulness of antibiotic prophylaxis for known tick bites, the effectiveness of erythema migrans treatment and the role of antibiotic retreatment in patients with persistent manifestations of Lyme disease. Healthcare providers who evaluate and manage patients with Lyme disease are the intended users of the new ILADS guidelines, which replace those issued in 2004 (Exp Rev Anti-infect Ther 2004;2:S1–13). These clinical practice guidelines are intended to assist clinicians by presenting evidence-based treatment recommendations, which follow the Grading of Recommendations Assessment, Development and Evaluation system. ILADS guidelines are not intended to be the sole source of guidance in managing Lyme disease and they should not be viewed as a substitute for clinical judgment nor used to establish treatment protocols.
Evidence-based medicine is the integration of best research evidence with clinical expertise and patient values [1]. The International Lyme and Associated Diseases Society (ILADS) has adopted the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system as its basis for evidence assessment and the development of recommendations to ensure a transparent and trustworthy guideline process [2–5].
These guidelines address three fundamental treatment questions: the usefulness of antibiotic prophylaxis for known tick bites, the effectiveness of erythema migrans (EM) treatment and the role of antibiotic retreatment in patients with persistent manifestations of Lyme disease. ILADS anticipates performing GRADE assessments on additional topics related to the diagnosis and treatment of tick-borne diseases in the future.
The GRADE scheme classifies the quality of the evidence as high, moderate, low or very low. The quality of evidence from randomized controlled trials (RCTs) is initially rated as high, but may be downgraded based on five limitations: study bias, publication bias, indirectness (generalizability), imprecision and inconsistency. Evidence quality from observational studies is generally low, but may be upgraded based on a large effect or dose–response gradient [6]. Rather than labeling recommendations as strong or weak, these guidelines use the terms ‘recommendation’ or ‘strong recommendation’ for or against a medical intervention. The GRADE scheme itself is a continually evolving system. These guidelines attempt to incorporate the current state of GRADE.
Although Lyme disease is not rare, the treatment of Lyme disease has not attracted pharmaceutical interest and the evidence base for treating Lyme disease is best described as sparse, conflicting and emerging. For example, Hayes and Mead of the CDC performed a systematic review of the evidence regarding the treatment of late neurologic Lyme disease and their GRADE-based evaluation rated the quality of the evidence as very low [7]. The ILADS guidelines working group reached a similar conclusion after assessing the research evidence pertaining to its three clinical questions, rating the evidence quality as very low. The low quality of evidence seen in Lyme disease is consistent with the evidence base for the field as a whole. Indeed, the majority of recommendations in infectious disease medicine generally are based on low-quality evidence [8].
When high-quality evidence is not available, guideline panels are faced with making recommendations based on low- or very low-quality evidence. Although evidence alone is never sufficient to determine guideline recommendations [2], when evidence is weak, the values of those on the panel, including differing specialty perspectives, may carry more weight [8]. One of the goals of the GRADE scheme is to make the value judgments underlying recommendations transparent.
When the evidence base is of low or very low quality, guideline panels should be circumspect about making strong recommendations to avoid encouraging uniform practices that are not in the patient’s best interest and to ensure that research regarding benefits and risks is not suppressed [8]. Guidelines panels should also make the role of their values and those of patients in recommendations explicit and should promote informing and empowering patients to engage in shared decision-making [8].
This panel has placed a high value on the ability of the clinician to exercise clinical judgment. In the view of the panel, guidelines should not constrain the treating clinician from exercising clinical judgment in the absence of strong and compelling evidence to the contrary [9].
In addition, this panel believes the goals of medical care in Lyme disease are to prevent the illness whenever possible and to cure the illness when it occurs. When this is not possible, the panel believes the emphasis for treatment should be on reducing patient morbidity. Therefore, the panel placed a high value on reducing patient risks for developing the chronic form of the disease and on reducing the serious morbidity associated with these disease forms. Thus, the panel’s values align with the Institute of Medicine (IOM) goal of reducing the impact of chronic illness at the individual and national levels by, among other things, treating the treatable [10]. To this end, the panel valued primary prevention (by effectively treating a tick bite), secondary prevention (by treating an EM rash sufficiently so as to restore health and prevent disease progression) and tertiary prevention (by treating patients whose illness may be responsive to additional therapy, thereby reducing the morbidity associated with the chronic forms of the disease).
ILADS is mindful of the role of patient preferences and values in GRADE as well as the IOM’s call for patient-centered care that is responsive to the needs, values and expressed preferences of individual patients [11]. Patient-centered care focuses on achieving treatment outcomes that patients value [11], including the restoration of health, prevention of health deterioration and the provision of treatments that have the potential to improve quality of life (QoL). To facilitate the development of treatment plans addressing the unique circumstances and values of individual patients, patient-centered care encourages shared medical decision-making.
Shared decision-making takes into account the best scientific evidence available, clinical expertise and the role of patient’s values and preferences in deciding among available treatment options [12,13]. Despite the terminology, decision-making is not truly shared between clinician and patient; the responsibility for choosing between options remains with the clinician.
To effectively engage in shared decision-making, patients need to understand the implications of their choices. Physicians should not assume that patients share their values in making risk/benefit determinations. Studies have demonstrated that patients and physicians may have very different assessments of preferences and risk tolerance [8]. In addition, there is considerable variation among individual patients in their tolerance for risk and in what they regard as a valuable benefit. Patients may also tolerate more risk when they have severe presentations of disease or when there are no other treatment options available [14].
In the GRADE system, recommendations take into account not only the quality of the evidence, but also the balance between benefits and harms and patient values and preferences [5]. In instances where a GRADE evaluation concludes that the evidence quality is low or very low or that there are trade-offs between risks and benefits that depend on the values of the individual, the GRADE system recommends that recommendations should identify a range of therapeutic options and acknowledge that different choices may be appropriate for different patients.
In assessing the balance between the risks and benefits of antibiotic treatments for Lyme disease, the panel weighed the burden of disease, the magnitude and relative importance of patient-centered outcomes as well as treatment-associated risks and the risks attendant on not treating. The panel acknowledged that the health-related and economic consequences of chronic disease are enormous for individuals, families, communities, healthcare systems and the nation, impacting the wellbeing of individuals, family functioning and economic productivity [15–18]. Therefore, the panel recommends that patients be informed of the risks and benefits of treating and not treating, including the risks of continuing to suffer significant morbidity or permitting a serious systemic infection to progress.
The panel assessed risks and benefits of treatment on a generalized basis. In addition, the panel recognizes that there is a need for clinicians, in the context of shared medical decision-making, to engage in a risk–benefit assessment that reflects the individual values of the particular patient.
Guidelines for the diagnosis and treatment of Lyme disease are conflicting (Supplementary Appendix I [Supplementary material can be found online at www.informahealthcare.com/suppl/10.1586/14787210.2014.940900]) The IOM recently highlighted the conflicting Lyme guidelines of ILADS and the Infectious Diseases Society of America (IDSA) and noted that the National Guidelines Clearinghouse has identified at least 25 different conditions in which conflicting guidelines exist [19]. According to the IOM, conflicting guidelines most often arise when evidence is weak, organizations use different assessment schemes or when guideline developers place different values on the benefits and harms of interventions [20].
The adoption of GRADE by ILADS is, in part, an effort to use the same assessment scheme as the IDSA, although it should be noted that the IDSA’s Lyme disease guidelines listed on the National Guidelines Clearinghouse were originally published in 2006 and do not reflect the organization’s adoption of GRADE for guideline revisions after 2008. Additionally, the use of GRADE is one element of ILADS’ compliance with the eight standards identified by the IOM as being integral to creating trustworthy treatment guidelines (Supplementary Appendix II).
The guidelines were developed in phases. A working group identified three questions to address, conducted a literature search and subsequent assessment of the evidence quality and evaluated the role of patient preferences and values for each question. A preliminary draft of the guidelines was sent to the full guidelines panel and, subsequently, outside reviewers for review and comment, with the document being further refined. The panel and working group members were required to disclose potential financial conflicts of interest. The full panel, which consisted of the board of directors of ILADS, determined that fee for service payments are inherent in the provision of healthcare and did not disqualify experienced clinicians from serving on the guideline panel nor did serving on the boards of non-profit organizations related to Lyme disease. Financial relationships exceeding US$10,000 per year that were not intrinsic to medical practice were viewed as potential conflicts; no panel or working group members held such financial conflicts of interest.
Link to full publication https://www.tandfonline.com/doi/full/10.1586/14787210.2014.940900
Phyllis Mervine
	President, LymeDisease.org
Melissa Potter
LymeDisease.org is one of the oldest Lyme nonprofits in the nation. We have played an instrumental role in patient and science-based advocacy both in connection with Lyme disease and more broadly in national healthcare policy. Members of LymeDisease.org have served on advisory panels, and presented on patient engagement in government funded organizations such as the Patient Centered Outcomes Research Institute, the NIH Collaboratory, the White House Precision Medicine Initiative, as patient partners for the Society to Improve Diagnosis in Medicine, and as subcommittee members for this working group. We advise researchers at the University of Chicago, and we have authored two academic text book chapters on patient engagement and patient registries.
We know a lot about how to treat early Lyme disease, but even so, treatment failure rates remain unacceptably high (10-20%). We know very little about what works—what is effective—for treating late or persistent Lyme disease. NIH funded trials in persistent Lyme disease have been very small (37-129 people) and, by their nature, do not observe real world patients responding to the variety of clinical treatments used to improve patient quality of life. This is an area in which patient registries excel. At the last Tick-Borne Disease Working Group meeting, Dennis Dixon noted that patient registries are one way to advance the knowledge of Lyme disease. However, neither he nor this group seemed to be aware that a large patient registry for Lyme disease presently exists.
MyLymeData is a patient registry developed by LymeDisease.org that enables patients to pool longitudinal healthcare data. Since its launch in November 2015, over 12,000 patients have enrolled. It is modeled after many of the rare disease registries and adheres to the patient registry recommendations of the Agency for Health Research Quality. Like most patient registries, entry criteria is intentionally broad -- patients must be US residents clinically diagnosed with Lyme disease.
The registry has gathered over two million data points on Lyme disease demographics, tick bites, diagnosis, symptoms, lab tests, co-infection, treatment and quality of life. Last year, we published our first peer-reviewed study analyzing data from the registry. We also released our MyLymeData Chart Book- highlighting results from Phase 1 of the study— the chartbook may be accessed here: [https://doi.org/10.6084/m9.figshare.7849244]
We are collaborating on a tissue bio-repository with the National Disease Research Interchange and Bay Area Lyme Foundation, and are working with academic researchers at UCLA and the University of Washington. The National Science Foundation has funded UCLA researchers to explore big data analytics using data from MyLymeData. This has been an essential step in building a collaborative research engine designed to realize the promise of big data in Lyme disease.
All the best,
	Melissa Potter
	LymeDisease.org
Carl Tuttle
Providing comments in support of the Change.org petition calling for a congressional investigation into the mishandling of Lyme disease.
This whole IDSA illusion that Lyme disease is *“hard to catch and easily treated”*is based on the acute stage of disease with early treatment and it is blatantly obvious. Patients who advance to late stage and are horribly disabled are completely ignored and there are no studies to help these people to determine what caused the disability and what we can do to relieve the disabling symptoms. The truth about the disease has been kept from the public while suppressing evidence of Congenital Transmission along with persistent infection after aggressive antibiotic treatment.
Congenital transmission is just now being recognized by the CDC almost four decades after the disease was identified? So obviously there is a deliberate disinformation campaign to downplay the severity of Lyme disease and this racketeering scheme continues today well financed through the Centers for Disease Control with an open checkbook under grant number **RO1 CK 000152**
**NIH Online Reporting Tools**
https://projectreporter.nih.gov/project_info_history.cfm?aid=8707215&icde=48502354
The CDC together with the academics named in the **Lisa Torrey vs IDSA** racketeering lawsuit has orchestrated this deception on the public.
So why are those responsible for this mess still in control? Who appointed **Eugene Shapiro** to the Tick-Borne Disease Working Group?
Until those responsible for this health disaster are removed from positions of authority we will have another decade of unimaginable pain and suffering.
**Quote from a clinician on the front lines treating this epidemic:**
“We are seeing so many young people, previously completely healthy & vital with lives totally de-railed by (the disease that does not exist) chronic Lyme disease.  The medical profession is entirely 'blind' to this devastating, complex, multi-system illness that, in aggregate, can be totally disabling. (not to mention, of course, the compounding factors of co-infections making their illnesses even more complex). To me, it’s like playing 3 simultaneous games of chess against 3 opposing 'Chess-masters'”  **-Kenneth Liegner, MD**
We are dealing with a life-altering/life-threatening infection with faulty/misleading antibody tests, inadequate treatment, no medical training and absolutely no disease control whatsoever; a public health disaster misclassified as a low-risk and non-urgent health threat.
Lyme disease is a 21st Century plague hidden in plain sight as patient testimony all across America is describing a disease that is destroying lives, ending careers while leaving its victim in financial ruin. ..... Lyme disease is a public health emergency!
**A report to the HHS Secretary and Congress was already submitted in 2018**:
https://www.hhs.gov/sites/default/files/tbdwg-report-to-congress-2018.pdf
So where is the **Manhattan Project** to find a cure for this antibiotic resistant/tolerant superbug?
Carl Tuttle
	Lyme Endemic Hudson, NH

                    
  


Content created by Office of Infectious Disease and HIV/AIDS Policy (OIDP) Content last reviewed February 26, 2020Back to top
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