TBDWG January 28-29, 2020 - Written Public Comment

This webpage displays the written comments received by the Tick-Borne Disease Working Group for the January 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.

Anonymous 1

I am commenting as both a patient and a parent of a patient. My symptoms started in 1997, but unfortunately remained undiagnosed for 9 months, during which time I suffered with numerous ailments, but continued to breast feed my daughter. At the time, the doctor insisted that my pain was typical for thalassemia, even though I have had thalassemia minor all of my life and had not experienced the existing symptoms. I was not given a Lyme Disease clinical diagnosis chart although my husband and I raised the possibility of Lyme Disease. Nine months later, in the same office, a different doctor diagnosed me as having both Lyme and Babesia, which were confirmed by serological testing. Antibiotic treatment continued on and off for years. In 2004, I began having problems swallowing and had frequent vomiting episodes. I was eventually diagnosed with achalasia. I had been suffering with chest pain for years. I underwent surgery; a myotomy with a difundoplication, removal of my gall bladder, and repair of a hernia. After many years, I now function at a decent level, but still have numerous chronic Lyme symptoms, however, my daughter, being only 1 year old when she was infected by my breast milk, and not being diagnosed for over 5 years, is a much more painful history. In 1998, as soon as I was diagnosed, I stopped breast feeding and immediately had our daughter tested by the pediatrician. We were told that the results were negative. Over the years she had neurological symptoms, including learning disabilities and depression. In 2002 she was given IV antibiotics for a skin infection. Soon after, she developed uveitis, however, the pediatricians treated it as a routine conjunctivitis. Her left eye repeatedly turned red and painful after each course of polymyxin B sulfate. The pediatrician never referred her to an ophthalmologist, but realizing that something was very wrong we took her to our optometrist who immediately called a pediatric ophthalmologist. She was seen that day. Both the optometrist and ophthalmologist said it was the worst case of uveitis they had ever seen in a child. We were told that the uveitis was so advanced that she could end up with permanent blindness in her left eye. We had to give her medication every two hours through the night to try to break the adhesions. She remained on ophthalmic steroids for many years.  She retained her sight but there are long term concerns for her eye. We insisted on testing to determine the underlying cause of the uveitis. The same pediatrician tested her for Lyme and once again told us that the results were negative. I asked them to fax me the results, which they initially refused to do. I did obtain them and took them to my doctor who said that he would not consider it a negative result, especially given the uveitis and her history. She was retested using the Igenex laboratory, and those results were clearly positive. She was treated by a wonderful pediatric Lyme specialist and Lyme literate ophthalmologist who worked in concert. She remained on antibiotics and ophthalmic steroids for many years until the uveitis resolved. Regarding our daughter’s pediatricians who misdiagnosed both her Lyme and uveitis, we stopped going to them but did speak to them about the pain and suffering their misdiagnoses caused our child. One pediatrician admitted that our daughter should have been referred to a specialist for her eye, however, when the head of the group was questioned about the laboratories he uses for Lyme testing, he vehemently criticized Lyme literate laboratories like Igenex and Stony Brook, saying that they resulted in too many positive Lyme tests. To this day, 18 years later, I am infuriated by a pediatrician who can justify false negatives after seeing the long- term suffering, neurologic issues and near blindness that resulted for my daughter.

I sincerely hope that the TBDWG is successful in the goal of enhanced training for HC providers, and rapid and accurate diagnoses. Transmission of Lyme through breast milk, not accepted by mainstream medicine, is required. I also advocate for improved education regarding chronic Lyme and symptom persistence, use of appropriate tests and testing laboratories, and better treatments for patients like my daughter and me.

Anonymous 2

To the Federal Tick-borne Disease Working Group (TBDWG),

Lyme disease (Borrelia burgdorferi) is a complex issue that needs expedient actions taken in both our nation and worldwide.  I appreciate your efforts to make improvements and thank you for providing me an avenue by which to share my concerns.

As a member and co-chair of the Newtown Lyme Disease Task Force in Connecticut (CT), I saw first-hand the devastation that Lyme disease created for both my family and our community. In the summer of 1999, myself, my husband and our three children were all diagnosed with Lyme disease. My children also had lab indications of Ehrlichia infection, and I was symptomatic and diagnosed with babesiosis. Unfortunately, we were diagnosed many years after first presenting with symptoms. My son and I were not diagnosed when we became ill due to our physician’s reliance on blood tests that were false-negative or read incorrectly based on surveillance criteria. Therefore, all of our symptoms were negated and our diseases were allowed to progress.

Lyme disease is a clinical diagnosis; tests results should only be used as supportive data.  Reliance on imperfect tests can result in delay and failure to treat Lyme disease, which, in the case of my family, led to difficult-to-treat Lyme disease symptoms, permanent residual damages, additional costs and unnecessary suffering.  This is first and foremost what the TBDWG should be conveying to physicians- that testing is not accurate and reliance on surveillance criteria is incorrect!

As you know, ticks can harbor many disease-causing organisms aside from the spirochetes that cause Lyme disease. Ehrlichia, bartonella, Anaplasma, relapsing fevers and Babesia are a few, but there are many others. Borrelia miyamotoi in ticks is increasing and can be passed transovarially to larval ticks that are too tiny for most to see. (2). Many people, including medical professionals in Connecticut, are not aware that a tick may transmit more than Lyme disease and if not diagnosed and treated early a number of these diseases may be deadly.

Funding allotted to the Connecticut Department of Public Health for prevention and reporting purposes has not made a significant impact; it’s as if the millions in grant monies disappeared into thin air. Consequently, additional funding for a major education and prevention program is essential and should be implemented immediately and monitored closely. The numerous support groups and Lyme action groups throughout CT are a testimony of the neglect that has occurred with Lyme disease funding given to the CT Department of Public Health. There must be oversight with unbiased leadership in the next round of funding to assess the why, where and who the funding will be given to. The same universities and individuals in the past who have studied tick-borne diseases and have not made a true impact should be assessed for their validity going forward.

In a 2004 issue of Emerging Infectious Disease, John Anderson and Louis Magnarelli (2) stated that with such extensive human exposure to ticks and a relatively large number of Lyme disease cases in four towns [Greenwich, Stamford, New Canaan, and Darien] and elsewhere in Fairfield County, the number of cases of Babesiosis is likely to increase appreciably in the future.

The parasite that causes babesiosis can destroy red blood cells and cause a malaria like illness which is potentially fatal. Its symptoms may include fever, chills, sweats, muscle pains, breathing difficulties, headaches and malaise. Many symptoms overlap with symptoms of Lyme, and treatment for each infection is different. Increasing numbers of people in CT are being diagnosed with babesiosis, yet many physicians in CT are still not aware of it or test for it.

Some patients in whom Lyme disease was diagnosed have also been simultaneously infected with additional tick-borne diseases. Physicians should be alerted to the fact that their patients could be co-infected with various Lyme disease strains, human granulocytic ehrlichiosis, spotted fevers, viruses and more.

You would be hard pressed to find someone in Newtown, CT who did not at some point have Lyme disease or did not have a family member or neighbor with the disease. A growing number of students in the Newtown district have been on IV PICC lines for long-term antibiotic treatment. There are students requiring educational allowances and/or IEP and 504 plans because of cognitive and or physical impairment related to Lyme. There are also an increasing number of children who have missed numerous days of school, even months to years, due to complications of tick-borne diseases.

In 2001, Millward Brown, the worldwide supplier of consumer research, did a survey regarding the presence of diagnosed Lyme disease in Wilton, Ridgefield and Newtown, CT (3). Results indicated 39 percent of households surveyed have some member who has been diagnosed with Lyme disease. Of those diagnosed almost one quarter of them stated they had lingering symptoms (5% of the town’s population). One can only imagine over the years how much needless suffering has been going on and how the incidence rate has grown.

As a volunteer Lyme advocate I receive too many calls similar to my family’s story. People who were not only denied treatment based on blood tests, but misdiagnosed with other disorders which Lyme frequently resembles, including fibromyalgia, chronic fatigue syndrome, multiple sclerosis, ALS and lupus to name a few. Lyme is often compared to syphilis because they are both caused by spirochetes and present as a multisystem illness (4). Lyme disease may present with a variety of psychiatric disorders, which may include, but are not limited to ADD, bipolar, sleep disorders, depression, and anxiety (5). Many people with Lyme and tick-borne diseases are left chronically ill.

The incidence of Lyme and other tick-borne diseases in CT is increasing. Lyme disease accounted for 82% of all tickborne disease reports during 2004-2016 (6). Surveillance, however, is downplayed in Connecticut as health departments shifted from mandatory laboratory reporting to no laboratory reporting, and have gone back to laboratory reporting (with a major decrease in the number of labs reporting). The CT State Health Department neglected to inform the public appropriately that the decrease in numbers of cases from 4,631 in 2001 to 1268 confirmed/591 probable in 2018 was a paper drop. How can we even begin to manage what we cannot measure?

Lyme disease continues to be a major public health issue. Our children run the greatest risk of contracting this disease. Deer populations are exploding, and the number of ticks infected are increasing. Clearly more needs to be done at local, state and federal levels. We need funding to provide for proactive and expedient education of our community and physicians. Resources are needed to stop the spread of Lyme and other tick-borne diseases by reducing the tick and deer populations, and the allocation of research funds for better testing, treatment and cure.

The appointment of Eugene Shapiro as a member of the TBDWG is an atrocity. He has been shown to be a physician who is heavily invested in maintaining the status quo by falsely claiming Lyme disease is easily diagnosed, treated and cured, especially among our children. Between his proven conflicts of interest and his well-publicized one-sided view point, Shapiro has no right being part of this committee.

As a volunteer, I would answer the Newtown Lyme Disease Task Force hotline. More than a few times parents would call and expressed their concern about their child’s visit with Eugene Shapiro. Shapiro must be removed in order to restore the Lyme community’s faith in the TBDWG. After all, the credibility of the TBDWG, our health and our lives are at stake.

The burden of Lyme and other tick-borne diseases will negatively affect our country as millions more become infected, along with the millions already infected. Additionally, the increase in gestational Lyme (7) and other tick-borne diseases will take its toll not only in suffering, but it will devastate our country financially.

One suggestion as an addition to the comprehensive work the TBDWG is doing is to outreach to communities. Plan a visit to a community in CT, MD, VT, CA etc. and ask the communities to provide input. Individual testimony is helpful, but it does not fully inform of the true magnitude of these diseases. Veterinarians, school nurses, shop owners, families, support groups, doctors would all provide testimony to number of people being infected and chronically symptomatic. A townhall meeting of the people affected would provide valuable information to our government as well as systematically rigid studies that are not real world as to the devastation of tick-borne diseases.

The TBDWG can make a difference when working with an ever-growing community of Lyme advocates, activists, researchers, doctors and legislators.

References

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3322794/
  2. https://www.ncbi.nlm.nih.gov/pubmed/30846418
  3. https://www.cga.ct.gov/2007/phdata/tmy/2007HB-05747-R000226-Maggie%20Shaw,%20Chair,%20Newtown%20Lyme%20Disease%20Task%20Force-TMY.PDF
  4. https://www.ncbi.nlm.nih.gov/pubmed/18564251
  5. https://www.ncbi.nlm.nih.gov/pubmed/31597359
  6. https://www.ncbi.nlm.nih.gov/pubmed/29723166
  7. https://www.ncbi.nlm.nih.gov/pubmed/10666804

Anonymous 3

Controlling tick-borne pathogens to prevent human illness is and should be one of the highest priorities of the U.S. Government and specifically the U.S. Centers for Disease Control and Prevention. Even though Lyme disease is a threat to much of the public, controlling this pathogen over the large area necessary remains one of the greatest vector-borne disease control challenges of our lifetime. It is a challenge on the level of the Onchocerciasis Control Program in West Africa but has received insufficient resources for too many years. While understanding the basic biology and distribution of ticks and the pathogens they carry has been a priority even if underfunded, funding on how to control them has been even more limited.

This Working Group initiative serves as an opportunity to significantly advance the science of tick and tick-borne pathogen control and treatment. And this working group is correct to highlight the need for basic research on the biology and distribution of tick species. It is important to provide the funding to institutions with the expertise and resources available to properly conduct the research which means most of the funding will go to universities as they are the best-established entities to conduct the research. But “surveillance is sexy” and most researchers want to remain in the safe space of conducting basic biological studies making maps and tying species presence to pathogen presence. They default to writing mathematical models that may result in an increased number of publications but produce little if any positive outcome in the real world. Product development and product testing that results in novel ways to control ticks and tick-borne pathogens is difficult with a high probability of failure, which doesn’t lend itself to publishing in “high impact” journals which makes tenure review difficult and leaves holes in the next NIH or NSF grant application.

To guide the research and overcome a gap in real world expertise, in the earliest stages of tick control research representatives from organizations with on the ground experience such as professionals from mosquito control districts should be consulted for their expertise on controlling disease vectors over large areas. While they do not focus on ticks, they are some of the best experts available with practical experience in wide area vector control efforts and with the proper tools and state and federal support, tick control or product testing could become part of their duties. With the necessary support perhaps “tick control districts” could be established in the Northeast U.S. to deploy novel tick control technology and strategies where organized mosquito control is unnecessary or lacking. Their involvement in the early stages of R&D will be critical to finding a strategy or technology that works.

Industry representatives and pest control companies should be involved also at the early stages for their understanding of product development, registration and use in the real world outside of the ivory tower to avoid the “valley of death” in product development. While specifically discussing new drug development Coller and Califf (2009) provide six questions that should be considered before tick control research is funded: 1) Is it worth the effort? 2) Is there an adequate potential market? 3) What can be inferred from human and animal data about likely safety and efficacy? 4) Can the agent be delivered to its target at an adequate concentration? 5) Is there an industry partner that can develop the agent effectively and efficiently? And 6) Can a pivotal trial be designed and completed?

Asking these six questions and including experts outside of academia in the mosquito and pest control world will help funded academic researchers understand that the “valley of death” in research is real. To help make the valley of death shallower, research that is a collaboration of real-world expertise that possibly focuses using or re purposing tools and technology already approved (such as U.S. EPA approved insecticides) to control ticks now should be as a high priority as funding projects on basic biology and distribution.

Coller, B.S. and R. M. Califf. 2009. Traversing the valley of death: A guide to assessing the prospects for translational success. Sci Transl Med. December; 1(10): 10cm9. Doi:10.1126/scitranslmed.30000265.

Debra Ben Avram, Kate Fry, J. Chris Hrouda, Joanne Kurtzberg, Navneet Majhail, Steven Devine

The undersigned organizations support the critical work being done by the Tick-Borne Disease Working Group (TBDWG). Vector-borne diseases, including tick-borne diseases, create multifaceted and interdisciplinary public health challenges. We appreciate the TBDWG’s plans to address the risks associated with tick-borne diseases and applaud policymakers’ commitment to addressing tick-borne diseases through the recently enacted Kay Hagan Tick Act. We hope that the ongoing efforts of this Working Group and the efforts resulting from the Kay Hagan Tick Act will improve our understanding of existing tick-borne diseases, enable the rapid detection of new disease agents, result in effective prevention and improve the public’s health.

Blood transfusions are medically necessary, routine treatments for patients with chronic health conditions, life-saving therapies for patients who experience blood loss from trauma or surgery and must be available in emergencies. A variety of human cells, tissues, and cellular and tissue-based products (HCT/Ps) are used as cellular therapies and other biotherapies to treat different diseases or conditions. For instance, hematopoietic stem cells are used to treat leukemia, lymphoma and sickle cell disease.

As the TBDWG recognized in its 2018 Report to Congress, tick-borne pathogens are quite diverse, and methods of transmission differ. While there is evidence that some existing tick-borne diseases can be transmitted via blood transfusions, other tick-borne diseases have not been linked to blood transfusions or therapies involving HCT/Ps.  For example, despite the prevalence of Lyme disease in the general U.S. population, we have not seen evidence that Lyme disease can be transmitted via blood transfusion or therapies involving HCT/Ps.  We are encouraged that the efforts of the TBDWG and resulting activities have the potential to add to the evidence and result in improved, evidence-based policymaking that reflects documented risk.

Thus, as detailed below, we encourage the TBDWG to include in its report to Congress the following recommendations to ensure that current, evidence-based policies protect the safety and availability of the nation’s blood supply as well as HCT/Ps:

  1. Ensure that surveillance and research findings are shared with the Food and Drug Administration’s Center for Biologics Research and Evaluation in a timely manner to inform evidence-based policies.
  2. Recognize gaps in research related to the impact of tick-borne diseases on the blood supply as well as on cellular therapies and biotherapies.
  3. Consult with individuals with expertise in the impact of tick-borne diseases on the safety and availability of blood and HCT/Ps.
  4. Encourage the safety and availability of blood and HCT/Ps to be integrated into the national strategy for tick-borne diseases.

We recommend that surveillance and research findings be shared with the Food and Drug Administration’s Center for Biologics Research and Evaluation in a timely manner to inform evidence-based policies.

Our organizations appreciate the TBDWG’s efforts to ensure interagency coordination related to tick-borne diseases and believe that continued communication and coordination between Federal agencies and departments is essential for implementing evidence-based policies that protect the public’s health. We urge the TBDWG to recommend that the Center for Biologic Evaluation and Research (CBER) at the Food and Drug Administration (FDA) be given the opportunity to provide input into the design and implementation of surveillance, research, programs and other activities so that these efforts can be used to inform and update evidence-based policies impacting the blood, cellular therapies and biotherapies communities. Similarly, surveillance and findings from other programs and activities, including an absence of evidence implicating transmission risk, should be shared with CBER in a timely manner so that the policies regulating blood, cellular therapies and biotherapies are continuously aligned with current epidemiology and research findings.

For instance, FDA’s “Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Guidance for Industry” takes a risk-based, regional approach to regulating blood donations.1 Currently, FDA requires blood collection establishments to test blood donations when collected in 14 states (Connecticut, Delaware, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, Wisconsin) and Washington, D.C.  Given that the epidemiology of tick-borne diseases is continuously evolving,2 we support the TBDWG’s 2018 recommendation to “fund studies and activities on tick biology and tick-borne disease ecology, including systematic tick surveillance efforts particularly in regions beyond the Northeast and Upper Midwest.”3 We believe that the studies and surveillance efforts championed by the TBDWG can be used to inform FDA’s current and future policies.

As another example, novel and emerging tick-borne disease agents present significant challenges to FDA as well as to the blood and cellular therapies/biotherapies community. We support the Working Group’s 2018 recommendation to “fund systematic studies and activities to identify and characterize novel tick-borne disease agents in the United States,” and believe that these studies and activities should specifically address risk for transmission of novel tick-borne disease agents via blood transfusion or by HCT/Ps. Findings from such research and surveillance efforts, including evidence indicating an absence of risk, should be made immediately available to CBER to ensure that evidence-based policies are (1) implemented and continuously updated to protect the safety and availability of blood and HCT/Ps; (2) not overly burdensome in the absence of data implicating blood or HCT/Ps; and (3) support the availability of blood and HCT/Ps.

We recommend that the TBDWG specifically recognize gaps in research related to the impact of tick-borne diseases on the blood supply as well as on cellular therapies and biotherapies.

Investing in research is critical to preventing and mitigating the impact of tick-borne diseases. Comprehensive, timely surveillance data coupled with improved risk mitigation strategies, early diagnostics and additional treatment approaches can improve the public’s health and lessen the burdens associated with tick-borne diseases.  We appreciate that the TBDWG’s 2018 Report to Congress highlighted the following needs and gaps in research, and believe that these areas remain challenges and research priorities today:

  • Improve early and accurate diagnosis and treatment.
  • Strengthen national surveillance.
  • Understand the immunological mechanism (for example, the pathogen-host interaction) of immune protection for Lyme disease and other tick-borne diseases.
  • Develop new rapid and accurate lab tests.
  • Develop antibiotic combination and/or therapeutic options for treating acute and persistent illness.
  • Encourage the development of strategic plans for tick-borne disease Federal investments.
  • Dedicate funding to tick-borne diseases and evaluate related activities using performance indicators and clear metrics for success.
  • Characterize how tick-borne disease affects U.S. national security, military readiness, and the health and wellness of active duty Servicemembers, Veterans, and their families.

Potential risk of transmission through blood and HCT/Ps should be considered in each of these research areas. For example, we agree that the absence of reliable, national surveillance data is quite problematic and limits the nation’s ability to understand the epidemiology of tick-borne diseases. Enhanced national surveillance that tracks tick and human activities, including where and how specific tick-borne diseases are acquired (i.e., community, travel, via blood transfusion, via HCT/P, etc.), is key to developing and adopting evidence-based policies and procedures that are proportional to documented risk, mitigating the risks of these vector-borne diseases, and ensuring the availability of blood and HCT/Ps. In addition, we believe the TBDWG should recommend economic studies and activities related to the costs associated with preventing transmission and mitigating the risk of tick-borne diseases. For example, screening and testing blood for transfusion-transmitted babesiosis is a crucial public health function carried out by blood operators in select states. The current funding model is flawed and is not aligned to support this public health role. We believe that it is important to understand the economic impact of this type of public health activity, and to dedicate funds and develop reimbursement policies to support the function.

As the TBDWG continues its important work in shaping U.S. policy and activities related to tick-borne diseases, we encourage the group to consult with individuals with expertise in the impact of tick-borne diseases on the safety and availability of blood and HCT/Ps.

We recommend that the TBDWG engage with individuals from the blood and HCT/P communities who are uniquely qualified to support the efforts of the TBDWG and provide expertise on blood transfusion safety as well as transmission of diseases via HCT/Ps. For example, such individuals could provide the working group with epidemiological and clinical research expertise related to blood donor collections and screening processes, expertise related to transmission by HCT/Ps, as well as a robust understanding of operational considerations associated with risk mitigation.

We encourage the TBDWG to recommend that HHS appoint new members to the TBDWG or at a minimum, solicit input from external advisors, so the ongoing and future work can inform policies and practices that protect the safety and availability nation’s blood supply and HCT/Ps.

The safety and availability of blood and HCT/Ps should be integrated into the national strategy for tick-borne diseases.

We are encouraged that the Kay Hagan Tick Act dedicates funding for activities related to vector-borne diseases and requires HHS to develop a national strategy to address vector-borne diseases, including tick-borne diseases. We hope that HHS will use the important work being done by the TBDWG to inform this strategy, identify gaps and develop strategic goals and benchmarks related to addressing vector-borne diseases. Additionally, we believe HHS should consult with experts from the blood and cellular therapies/biotherapies community to ensure that the national strategy, identified gaps, strategic goals and benchmarks consider blood and HCT/P safety and availability in a manner consistent with the above recommendations.

  1. Food and Drug Administration, Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis, Guidance for Industry (May 2019), available at https://www.fda.gov/media/114847/download.
  2. Centers for Disease Control and Prevention. National Notifiable Diseases Surveillance System, Weekly Tables of Infectious Disease Data. Atlanta, GA. CDC Division of Health Informatics and Surveillance. Available at: https://www.cdc.gov/nndss/infectious-tables.html.
  3. Tick-Borne Disease Working Group: 2018 Report to Congress, available at https://www.hhs.gov/sites/default/files/tbdwg-report-to-congress-2018.pdf (last visited January 9, 2020).

Debra Ben Avram
Chief Executive Officer, AABB

Kate Fry
Chief Executive Officer, America’s Blood Centers

J. Chris Hrouda
President, Biomedical Services, American Red Cross

Joanne Kurtzberg, MD
President, Cord Blood Association

Navneet Majhail, MD, MS
President, American Society for Transplantation and Cellular Therapy

Steven Devine, MD
Chief Medical Officer, National Marrow Donor Program

Lucy Barnes

Bartonella - An Overlooked Tick Borne Infection With Serious Consequences! Research Grants Needed Immediately! (See information below.) The Lyme Disease Guideline Draft 2019 On Bartonella Is Dismissive & Dangerously Inaccurate!

The 2019 IDSA/ACR/AAN Lyme disease guideline draft incorrectly states (pg. 67): “Bartonella has not been established as an I. scapularis transmitted infection or as a co-transmitted agent with B. burgdorferi [331,350,351].”

The guideline authors refer to the following sources in an attempt to support their statement above. None of their listed references support their opinions. Hundreds of other scientific sources dispute their statement.

  1. (Reference #331)  Wormser, a guideline author, offers a non-scientific commentary that was published in time to be included as a reference in the 2019 guideline draft. If examined you will see Wormser’s opinion is simply supporting Wormser own opinion.  How convenient is that? We call this published fake document “fluff”- or fake padding- designed to fill in the gaps.
  2. (Reference #350)  Wormser as author, AGAIN. It was also written with no scientific basis or studies to support Wormsers’ opinion. It is reflective of his many publications written specifically to discredit various labs, tests, physicians, studies, treatments, etc. that do not support his position. We call this extremely biased and totally not credible. Keep in mind, to Wormser the words “convincing evidence” means whatever agrees and benefits him and his personal/financial agenda at the time. If the true science is not in agreement with Wormser, it is declared by him to be “not convincing”- end of story.
  3. (Reference #351)  As a reference, there is also a written review/opinion by TWO of the current guideline panel members- Wormser and Lantos, who is another 2019 panel member and lead author. They are two peas in a pod for continuing to use this same old unscrupulous method.

The true science refuting the “no Bartonella theory” opinion espoused by Wormser, et. al. is overwhelming. The many scientific studies come from various sources and from those who do not have an agenda, or multiple lawsuits and/or legal actions against them. For example…

Nedler, et. al. states-  “Blacklegged ticks harbored 91 distinct taxa, 16 of these are tick transmitted human pathogens, including species of Anaplasma, Babesia Bartonella, Borrelia, Ehrlichia, Rickettsia, Theileria and Flavivirus.” Nadler, et. al. continues- “Blacklegged ticks harbored one Bartonellaceae species, Bartonella henselae, which was only found in ticks from New Jersey (100 %; n = 1), New York (2.3 %; n = 88) and Pennsylvania (3.1 %; n = 544).” Nelder MP, Russell CB, Sheehan NJ, Sander B, Moore S, Li Y, et al. Human pathogens associated with the blacklegged tick Ixodes scapularis: a systematic review. Parasit Vectors (2016) 9:265. doi: 10.1186/s13071-016-1529-y. https://www.ncbi.nlm.nih.gov/pubmed/?term=Human+pathogens+associated+with+the+blacklegged+tick+Nedler

Another study single-handedly discredits the 2019 guideline statement on Bartonella & ticks.

Eskow, et. al. stated in 2001: “Patients residing in a Lyme-endemic area of New Jersey with ongoing symptoms attributed to chronic Lyme disease were evaluated for possible coinfection with Bartonella species. … Findings of cerebrospinal fluid analysis revealed the presence of both B henselae– and Borrelia burgdorferi–specific DNA.  Bartonella henselae–specific DNA was also detected in live deer ticks obtained from the households of 2 of these patients.”  Source - Eskow E, Rao RV, Mordechai E. Concurrent infection of the central nervous system by Borrelia burgdorferi and Bartonella henselae: evidence for a novel tick-borne disease complex. Arch Neurol. 2001;58:1357–63. https://jamanetwork.com/journals/jamaneurology/article-abstract/780359

A Sampling of Additional Studies Supporting Bartonella & Lyme in Ticks

“Overall, 129/929 (13.9%) Ixodes ticks were PCR positive for Borrelia burgdorferi sensu stricto, 48/929 for B. bissettiae whereas 23/929 (2.5%) were PCR positive for a Bartonella henselae.

For both bacterial genera, PCR positive rates were highly variable depending on geographic location and tick species, with Ixodes affinis (n = 155) collected from North Carolina, being the tick species with the highest prevalence's for both Borrelia spp. (63.2%) and B. henselae (10.3%). Based on the results of this and other published studies, improved understanding of the enzootic cycle, transmission dynamics, and vector competence of Ixodes species (especially I. affinis) for transmission of Borrelia spp. and B. henselae should be a public health research priority.”  Ticks Tick Borne Dis. 2019 Feb;10(2):360-364. doi: 10.1016/j.ttbdis.2018.11.015. Epub 2018 Nov 27. Regional prevalences of Borrelia burgdorferi, Borrelia bissettiae, and Bartonellahenselae in Ixodes affinis, Ixodes pacificus and Ixodes scapularis in the USA.  Maggi RG, Toliver M, Richardson T, Mather T, Breitschwerdt EB. https://www.ncbi.nlm.nih.gov/pubmed/30503356

“Blacklegged ticks harbored 91 distinct taxa, 16 of these are tick-transmitted human pathogens, including species of Anaplasma, Babesia, Bartonella, Borrelia, Ehrlichia, Rickettsia, Theileria and Flavivirus.”  Source- Parasit Vectors. 2016 May 5;9:265. doi: 10.1186/s13071-016-1529-y.

Human pathogens associated with the blacklegged tick Ixodes scapularis: a systematic review.

Nelder MP, Russell CB, Sheehan NJ, Sander B, Moore S, Li Y, Johnson S, Patel SN, Sider D. https://www.ncbi.nlm.nih.gov/pubmed/27151067

“Bartonella was present in larvae and nymphs of both tick species, even those scored as unengorged.”  Source-  Mol Ecol. 2015 May;24(10):2566-79. doi: 10.1111/mec.13187. Epub 2015 Apr 22.  Concordance of bacterial communities of two tick species and blood of their shared rodent host.  Rynkiewicz EC, Hemmerich C, Rusch DB, Fuqua C, Clay K. https://www.ncbi.nlm.nih.gov/pubmed/25847197

“Ixodes scapularis can be infected with Borrelia burgdorferi, Anaplasma phagocytophilum, Bartonella spp., Babesia microti, and Rickettsia spp., including spotted-fever group Rickettsia. As all of these microorganisms have been reported in Maryland, the potential for these ticks to have concurrent infections exists in this region.”  J Vector Ecol. 2007 Dec;32(2):243-51.

Co-circulating microorganisms in questing Ixodes scapularis nymphs in Maryland.

Swanson KI, Norris DE.  W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.

https://www.ncbi.nlm.nih.gov/pubmed/18260514

“PCR analysis of Ixodes scapularis ticks collected in New Jersey identified infections with Borrelia burgdorferi (33.6%), Babesia microti (8.4%), Anaplasma phagocytophila (1.9%), and Bartonella spp. (34.5%). The I. scapularis tick is a potential pathogen vector that can cause coinfection and contribute to the variety of clinical responses noted in some tick-borne disease patients.”  J Clin Microbiol. 2004 Jun;42(6):2799-801. Prevalence of Borrelia burgdorferi, Bartonella spp., Babesia microti, and Anaplasma phagocytophila in Ixodes scapularis ticks collected in Northern New Jersey.  Adelson ME, Rao RV, Tilton RC, Cabets K, Eskow E, Fein L, Occi JL, Mordechai E.  https://www.ncbi.nlm.nih.gov/pubmed/15184475

“Future coinfection research should focus on long-term clinical outcomes, the role of genetic variants, immunologic effects, and the potential role of Bartonella species as tick-borne pathogens.”  Vector Borne Zoonotic Dis. 2002 Winter;2(4):265-73.  Epidemiology and impact of coinfections acquired from Ixodes ticks.  Belongia EA. https://www.ncbi.nlm.nih.gov/pubmed/12804168

“Overall, 143 (52%) dogs were seropositive for B burgdorferi, 59 (21.3%) were seropositive for R rickettsii, 40 (14.4%) were seropositive for the HGE agent, 8 (2.9%) were seropositive for E canis, and 6 (2.2%) were seropositive for B vinsonii. Regression analysis indicated that the natural logarithm of nymphal deer tick abundance was correlated with rate of seropositivity to the HGE agent and to B burgdorferi but not to rate of seropositivity to R rickettsii, E canis, or B vinsonii.” 

J Am Vet Med Assoc. 2001 Apr 1;218(7):1092-7. Assessing the association between the geographic distribution of deer ticks and seropositivity rates to various tick-transmitted disease organisms in dogs. Hinrichsen VL, Whitworth UG, Breitschwerdt EB, Hegarty BC, Mather TN.  https://www.ncbi.nlm.nih.gov/pubmed/11318358

“B. henselae by cat fleas is better understood, although new potential vectors (ticks and biting flies) have been identified.”  Emerg Infect Dis. 2006 Mar;12(3):389-94.  Bartonella spp. in pets and effect on human health.  Chomel BB, Boulouis HJ, Maruyama S, Breitschwerdt EB. https://www.ncbi.nlm.nih.gov/pubmed/16704774

“Presence of Bartonella DNA was explored in 168 questing adult Ixodes pacificus ticks from Santa Cruz County, California. Bartonella henselae type I DNA was amplified from 11 ticks (6.55%); previously, two (1.19%) were found to be infected with Borrelia burgdorferi and five (2.98%) with Anaplasma phagocytophilum. Detection of B. henselae was not dependent on co-infection. The present study offers additional evidence that Ixodes spp. ticks may act as hosts and possibly vectors for B. henselae.”  Vector Borne Zoonotic Dis. 2006 Spring;6(1):99-102.

Co-detection of Bartonella henselae, Borrelia burgdorferi, and Anaplasma phagocytophilum in Ixodes pacificus ticks from California, USA.  Holden K, Boothby JT, Kasten RW, Chomel BB. https://www.ncbi.nlm.nih.gov/pubmed/16584332

“Arthropod-borne bacterial pathogen Bartonella DNA was detected in human blood cells after tick bites in summer 2003 and 2004 in Novosibirsk region by nested PCR with primers specific to groEL gene of HSP60 protein. Comparative assay of 190 p.b. of long PCR fragment revealed that the nucleotide sequences might belong to Bartonella henselae and Bartonella quintana.”  Mol Gen Mikrobiol Virusol. 2005;(4):14-7.  [Detection of the Bartonella DNA by the method of nested PCR in patients after tick bites in Novosibirsk region]. Morozova OV, Chernousova NIa, Morozov IV.  https://www.ncbi.nlm.nih.gov/pubmed/16334219

Funding for Bartonella research is a priority!

The most comprehensive and useful Bartonella related studies have been coming from Dr. Ed Breitschwerdt’s team in North Carolina. It appears he and others have been purposely overlooked when it comes to sharing the millions of tax-payer dollars allotted for tick borne disease research.  This situation needs to change immediately.

North Carolina Veterinary Medicine-  For over 30 years, Dr. Ed Breitschwerdt’s research has emphasized vector-transmitted, intracellular pathogens. Most recently, he has contributed to cutting-edge research in the areas of animal and human bartonellosis. In addition to authoring numerous book chapters and proceedings, Dr. Breitschwerdt’s research group has published more that 350 manuscripts in peer-reviewed scientific journals. [redacted}

Lucy Barnes
Director, Lyme Disease Education & Support Groups of Maryland

Calvin Broughton

Thank you for allowing this platform for us to address the board. I am 33 and have been living with persistent Lyme and co-infections for at least 7 years now. In 2013 I began experiencing chronic symptoms and over the course of 4 and ½ years I saw a combined 28 doctors and specialists at every renowned hospital in the region. I went on this search because I knew there was more going on internally than what was being told to me by many of these practitioners...and it just didn’t add up…Several ailments were noted, but no one would consider all aspects of my health and able to give me a definitive diagnosis. In the first year I was put on steroids and then methrotrexate for 3-6 months and quickly felt as if I was going to literally die. I was finally offered a Lyme test in 2016 that included all Lyme bands and I popped positive by the lab’s standards but not by the CDC.  I thought to myself, how could this be, that our medical system allows it to be this way and give so much room for controversy. I was one band shy by CDC criteria. One band shy from a potential chance at a different life.

At this point I tried to get into the research center at [redacted] and was denied. The Rheumatologist at the time claimed that the Lyme test crossed the eyes of the director and was told that he said that I do not have Lyme and to pursue treatment with DMARDS or Biologics. I’ll never know the truth on that one. If I knew then what I know now I would not have tried again, but after three months of a supposedly “softer” DMARD, I was at my worst. I finally gave up on the run around between specialist who proved unable to connect all the dots. At this point I was in musculoskeletal and neurologic pain from head to toe. Each system had become involved in some way and many aspects of cognition severely declined.

I need to step back for one second and also mention that my 4 and half year journey was also fueled by the dire need to find answers for [redacted]. If it weren’t for the demeaning comments by specialists, she had sought out for help then she would have not been pushed away by the pompous and at times sexist doctors that she had encountered. She ended up in the hospital with bell’s palsy and from there she was passed doctor to doctor and never experienced any follow through on blatant laboratory and image findings. She called to get the results and there was no mention of her positive Elisa test. A year goes by before another doctor requests labs and history from this office before we found out that she had positive serology at the time of an episode of bell’s palsy. The hospital also missed several scattered lesions on her brain that proved to be the cause her seizures. My point being that her case was more a little more straight-forward early on, but due to lack of communication by medical practices, obvious lack of care, and a faulty two-tiered lab test. They could have at least told her the information in order to make her own medical choices. [redacted].

After learning how faulty the Lyme test is, I started digging into the research on my own. I got sucked into the intricacies of it all and the magnitude of this silent epidemic of tick-borne disease as a whole. I gained some knowledge through sources like [redacted] books and translational specialist, [redacted], in Maryland..also herbalists, [redacted]. I also looked into the other side of the coin and the conventional stand points and spent many days reading published articles on the NIH site and pubmed, by members of the IDSA, but always just thought to myself, how could our medical system allow two extremely conflicting methods of care to exist. By the time I was properly diagnosed in late 2017 I had all bands positive and met full CDC criteria.

The 29th doctor I met with I chose because she had a background in rheumatology and treats using the guidelines of ILADS. Makes sense right…Find doctor that treats Lyme and could unravel these auto-immune markers, right? And she did just that. It was a long couple of years of treatment…but after pushing through 5 years of disability and still working in the DoD Medical Field I had to take the past two years off. [redacted] lost her job due to extended leave of absence from loss of functionality, but after proper diagnosis and same length of treatment, has regained enough strength to rejoin the workforce. It still remains a struggle with symptoms still persisting to varying degrees, but it is night and day difference from when [redacted] without our Lyme Literate physician. Through the 4 and ½ years of misdiagnosis and wrongful treatments so many other opportunistic infections became pathogenic, but [redacted] physician was on top of it every step of the way…...all the way up until this past fall where she was targeted and suspended.

Now after 2-3 years of making steady progress with [redacted] doctor, [redacted]…the state medical board has suspended her, endangering 100’s of patients that are currently stuck in a limbo. I know of one patient death, a hospitalization, plus our personal cases have suffered setbacks due to this horrific decision. I can’t fathom how decisions like this can continue to be made over the very crux of the issue that we are standing in this room figuring out. A lot of these gaps that have been identified here have been known by the Lyme community for years and lives are being affected as we speak and lifelines lost….all the while we have a class action suit in Texas against the IDSA, supposed top-doctors, and most major insurance companies….an active investigation into the DoD on the use of Lyme and ticks just before the initial outbreak in old Lyme, Connecticut began….and while its being acknowledged that longer courses of treatment may be deemed necessary, we know that the IDSA is currently revising guidelines to make  antibiotic guidelines more strict. Also, preventing psychiatrists from recommending Lyme tests whereas those are usually initial signs and present to throughout the progression of the disease, is plain ridiculous. Why are more gaps on gaps being created?! We need answers and action now.

[redacted]I declined [redacted] journey is unique, but contains a typical tale and pattern that I feel the Training, Education and Access to Care Subcommittee reported on with great detail and accuracy. I am one of the 12,000 registered patients on MyLymeData and the results are consistent with [redacted] journeys. It is a sad state of affairs truly, but I commend the committee for including results that have spawned directly from the us, the suffering warriors from all over the country.

As the Working group language uses…I have a few calls to action of my own for consideration:

  1. Raise the urgency level and get the education moving along via doctors and media outlets.  People will still be suffering tremendously while this 6-year mandate lasts and new clinical trials only beginning. The technology for a direct PCR lab test is out there for Lyme and would like to know why this was stonewalled years ago by the CDC after working with an independent lab on this very thing.
  2. I find it curious that in the subcommittee report for rickettsia’s, that the milder forms are being found in higher population percentages and more virulent forms in less dense populations…but showing higher densities moving this way where Lyme, bartonella, and babesia are already prevalent. Mild, or not these strains seem to co-exist and become more opportunistic and add to the overall bacterial load a patient may silently suffering from. The Sub-committee admits that the bacteria is rarely detected even when present which leaves very little confidence and extremely un assuring.
  3. MOLD and VIRUSES. Previous TBDWG identified gaps for co-infections and I would call these co-factors. It is my experience that Lyme and mold have a huge correlation. I believe, mold specialist, Dr. Shoemaker found that 40% of Lyme sufferers have mold infection and vice versa. Although not a Tick-Borne Disease…I would think this would be a major topic for the future group to explore along with the persistent reactivations of viruses that and further complicate the clinical picture.
  4. Disciplinary actions taken against life-saving doctors should halt until these gaps are addressed. How can we be doing this to people on a state level while this group is literally admitting that there is other ways and individualized care is necessary. It’s devastating in every way and I fear for my livelihood, and even more for my life.
  5. I was disappointed to see that the recommendation on sexual transmission of borrelia was to be of low priority in the future. If Babesia can be claimed as a less virulent form of malaria and Lyme is considered the less virulent, cousin spirochete, syphilis…then how can that not be further explored. I feel this is not only VITAL for all those that will potentially suffer but for the future of humanity as a whole. We steadily ask ourselves how is it spreading so fast? I feel more research into this is absolutely necessary.

I thank you for the opportunity to share my experience and concerns. I have other concerns relating to lack of diversity on the board this term and lack of medical professionals that adhere to ILADS guidelines, but I will save that for another time. I would like to give thanks to the doctors/authors previously mentioned and to groups like lymedisease.org and NatCapLyme, for if it weren’t for them, I would not have figured out what was wrong with me and not found proper care for myself and loved one.

Thank you for your time and for your hard work on these pressing matters.

Sincerely,
Calvin Broughton
Lyme Survivor

Dolores Claesson

We need better detection methods for ascertaining what pathogens have been injected, for antibody testing is not accurate and there are cross reactions and our immune systems are crippled with CVID or common variable immune deficiency. We cannot build sufficient antibodies to test positively. In addition, there are many pathogens that we currently have no commercial testing for, such as Midichloria mitochondrii. Next generation DNA sequencing might be the best method to figure out what is within people at the present time. Infectious Diseases Society physician guidelines should be used to line animal cages for they are worthless when it comes to treating the plethora of pathogens injected from various vectors. The Infectious Diseases Society has ignored very seriously ill patients over many decades. Many of the co-infecting agents can segue from an acute to chronic phase, such as Coxiella burnetti, Chlamydia pneumonaie, Mycoplasma pneumoniae, Borrelia and others. Borrelia hermsii, a known chronic relapsing fever borrelia is within many lyme patients and that is also not tested for on a regular basis. Education about vector borne disease and a concerted world wide effort to develop a cure for those pathogens needs to be undertaken. A comprehensive study on the immune systems of chronically ill patients with zoonotic pathogens would be the first step in trying to find a cure. I have a degree in Biology/Chemistry/MBA and am a retired VP of Goldman Sachs and have spent the last 12 years of my life researching and helping people with zoonotic pathogens and am thoroughly disgusted with the way Lyme patients are abused by the medical community.

Steven Drews

In the last few years, we have seen significant work on the remediation of Babesia risks to the blood supply. However, myself and several of my colleagues who are assessing stem cell, bone marrow and cord cell infectious disease risks see a dearth of guidance and comments regarding the risks of Babesia-transmission from stem cell products. We do know that there will be residual red blood cells in these products and some products may not be frozen, so the risk of infection is in the realm of possibility. Does the group foresee any formal risk assessment arising for the risk of Babesia transmission by stem cell products? Thanks

Steven J Drews PhD FCCM D(ABBM)
Associate Director (Microbiology)
Canadian Blood Services

Thomas J. File

The Infectious Diseases Society of America (IDSA) is writing to provide input to the Tick-borne Disease Working Group in preparation for its January 28-29 meeting at which it will consider reports from its subcommittees and a draft outline for its next report to Congress. IDSA strongly urges the Working Group to ground all its recommendations in the best available scientific evidence.

IDSA is the largest infectious diseases medical society in the United States, representing more than 12,000 physicians, scientists, public health practitioners and other health care professionals specializing in infectious diseases. Our members care for patients of all ages with serious infections, including tick-borne diseases. IDSA members focus on the epidemiology, diagnosis, investigation, prevention, and treatment of infectious diseases in the U.S. and abroad. We have sincere concern for patients who suffer from both short- and long-term effects of Lyme disease and other tick-borne diseases, and our goal is for all patients to achieve the best possible outcomes. We would be happy to serve as a resource for any issues surrounding tick-borne diseases.

IDSA supports the three topic briefs discussed at the September 12, 2019 Working Group meeting:

Topic Brief One- IDSA has routinely expressed strong support for more funding and research into epidemiology, prevention, as well as the underlying causes of the increasing burden of tick-borne diseases.

Topic Brief Two- We have also repeatedly advocated for more research to develop improved diagnostics for Lyme disease and other tick-borne diseases. Tests that can more accurately indicate the presence of infection, especially in the earliest phases of the disease, as well as distinguish between past and current infection will provide better management for patients.

Topic Brief Three- IDSA also has great sympathy for patients who continue to experience symptoms after recommended antibiotic treatment for Lyme disease. We encourage more research into the causes as well as potential treatments for longer-term symptoms. However, multiple peer-reviewed studies have demonstrated that prolonged exposure to antibiotics does not provide clinical benefit and in fact can cause significant harm to patients and even death.

IDSA greatly appreciates that the methodology for developing the briefs only considered peer-reviewed research from reputable scientific journals. We encourage the Working Group to adhere to this standard and not allow anecdotal evidence or research from non-reputable sources to be used as citations in the briefs or any other documents produced by the Working Group. We strongly recommend that any conclusions in the subcommittee presentations and any recommendations in Working Group documents be supported by the best and most current research available. Relying on anecdotal evidence to support continued antibiotic or other therapy for the treatment of Lyme disease is inappropriate, ineffective, and likely to cause harm to patients.

IDSA thanks the Working Group for its attention to tick-borne diseases and looks forward to the opportunity to help inform and advance evidence-based policy that will best serve the interests of patients and public health.

Sincerely,
Thomas J. File
President, IDSA

Bonnie Friedman

I'm not giving up! I've been fighting for credibility, hope and a cure for over 20 years. So many associations with tickborne diseases creating life long illness, disability and death. People are getting sicker and less help is to be found.
MS
ALS
Parkinsons
Lupus
If you look deep enough, you will find tickborne disease underneath. We need reseach by the right people, not those who stand to profit financially.

Bonnie Friedman
Ft. Myers, FL

Dorothy Leland

I live in California, where [redacted] contracted Lyme disease and co-infections about 15 years ago.

I’d like to discuss the CDC’s recently updated Lyme disease “incidence” map, which is misleading and may seriously harm patients who should be diagnosed. The map identifies 16 states as “high incidence” for Lyme. All other 34 are identified as “low incidence” states.

Here’s the problem: Doctors… and the public… who rely on these maps for diagnosis are likely to think—"Huh. Lyme is not problem in those 34 states.”

Even though Lyme-infected ticks can be found all over the country…even though Lyme disease has been documented in every state…even though early diagnosis and treatment is your best chance for a good outcome… many people can’t get properly evaluated for Lyme disease because they aren’t in one of the “magic 16” states.

Thus, even if someone has a known tick bite, an EM rash and other symptoms consistent with Lyme disease, their doctor may not even consider Lyme in the differential diagnosis. Because this map tells them it’s not a problem in their state.

Such “misdiagnosis by geography” has dogged Lyme patients for years. Thousands of people miss the critical window for early diagnosis and treatment of Lyme disease—and are unnecessarily left to languish in misery for months or years.

In 2017, the CDC reported 90 cases of Lyme disease in California. Yet, the FAIR Health insurance database identified more than 46,000 Lyme-related insurance claims in the state. [redacted] diagnosis was delayed eight months because physicians in California did not believe that Lyme disease was a problem here.

And there are similar mismatches in other purportedly “low incidence” states. CDC says North Carolina had 32 cases—yet there were more than 88,000 Lyme-related insurance claims. And Texas supposedly had 31 cases, but more than 31,000 Lyme insurance claims.

These discrepancies would be laughable—except they are so tragic.

A recent study by Quest Laboratories shows significant increases in positive Lyme tests in California, Florida, Georgia, Arizona, Ohio, Texas, and Tennessee—which are all designated “low incidence” states by the CDC.

There’s something wrong here. CDC’s system for keeping track of Lyme cases is deeply flawed. I call on this Working Group to let people know that Lyme disease is a problem in every state. No one with Lyme disease deserves to be left undiagnosed and consequently untreated.

Dorothy Leland
Vice-president of LymeDisease.org

Lonnie Marcum

I am a physical therapist, and a health and science writer for the nonprofit, LymeDisease.org. I am also a member of this working group’s Tick Biology, Ecology and Control subcommittee.

The fundamental goal of health care is to help patients find a rapid and proper diagnosis, receive the appropriate treatment, and return to a normal health. To shorten the duration of illness it is imperative that the CDC recommend only those treatments that will reduce the number of people who remain ill following treatment for Lyme disease.

Current evidence DOES NOT support a single dose of doxycycline, as recommended on the CDC website listed under “Tick Bite Prophylaxis,” because it DOES NOT ensure the best outcome for patients with Lyme and other tick-borne diseases. (CDC)

In the age of antibiotic stewardship, how is providing a single dose of ANY antibiotic practicing responsible medicine?

For instance, when a child has an ear infection, the pediatrician tells the parent to finish all the medication even if the child begins to feel better. The reason for this is that bacterial infections can build resistance to common antibiotics.

We already know that 10-20% of patients with early Lyme who receive a 2-4 week course of doxycycline will remain ill. (Aucott, et al, 2013; Fallon et al., 2008; Klempner et al., 2001; Krupp et al., 2003; Shadick et al., 1994). On top of that, up to 45% of ticks in some areas are co-infected with more than one pathogen. (Steiner 2008, Eliza ahead of print).

In truth, we have no data on what a single dose of doxy does to the course of human Lyme disease. For example, in a separate study of another tick-borne disease, Rocky Mountain spotted fever, antibiotic prophylaxis appeared to delay but not prevent infection in mice. (Kenyon 1978)

By design Borrelia are able to adapt and survive in extremely stressful environments. Their ability to survive the transfer from a mammalian host, to a tick, then to a human says a lot about their survivability. (Rudenko 2019)

Current microbiology has shown us that under stress, Borrelia can change form and hide from the immune system. Borrelia do this when exposed to anything that threatens their existence—including doxycycline. (Barthold, 1993; Cabello, 2017; Lewis, 2010; Hodzic, 2014).

Recent laboratory data out of Johns Hopkins university has shown that a 7-day course of Doxycycline allows 30-90% of the residual bacteria to keep growing. (Feng 2019) How many viable bacteria does a single dose of doxycycline leave?

The largest study, on which the CDC based its recommendation, showed one thing—a single dose of doxycycline reduced the incidence of rash in a small group of people. That’s it. (Nadelman 2001)

Currently the CDC recommends a single dose of doxycycline, as long as:

  1. There are no contraindications;
  2. The provider can identify the tick as a blacklegged tick;
  3. The patient can confirm it was attached for more than 36 hours;
  4. The treatment is started within 72 hours after tick removal and;
  5. The bite occurred in a county or state where Lyme is endemic.

These criteria are extremely problematic for several reasons:

  1. The ticks in the Nadelman study were identified by an entomologist. As the authors pointed out, patients and clinicians are not skilled  at distinguishing I. scapularis from other ticks and arthropods, and even from scabs or debris. (Sood 1997) Yet the CDC expects providers to properly identify ticks?
  2. While it’s accepted that ticks can transmit Lyme within 48 hours of attachment, there are unique conditions when it can be transmitted in under 24 hours.
  3. In addition, black-legged ticks contain multiple pathogens, which can be transmitted with a single tick bite. Some tick-borne pathogens can be transmitted within minutes (i.e., Borrelia hermsii and Powassan virus), while other tick-borne pathogens such as Anaplasma, Ehrlichia, Babesia, Rickettsia and other borrelia species take longer. (Eisen 2018) Yet the CDC says prophylaxis is appropriate after 108 (36 + 72) hours?
  4. Tick saliva has a chemical that numbs the site of the bite, therefore many patients can’t confirm the attachment time. The findings of a mouse study showed that initiating antibiotics more than 48 hours post tick removal was ineffective for preventing Lyme disease. (Piesman 2012)  Another study showed that Borrelia invade the lymphatic system within 24 hours. (Elsner 2015) In addition, ticks that carry Lyme disease have been found in 42 out of 58 counties in California, yet the Naddleman study did not include one incident of Lyme acquired by the Western black-legged tick (Ixodes scapularis). (CDPH)
  5. The authors of this study state: “The primary end point was the development of erythema migrans at the site of the tick bite.” In their conclusion they go on to say, “The efficacy rate found in our study should be interpreted cautiously, however, because of the relatively small number of subjects in whom Lyme disease developed and the resultant wide 95 percent confidence interval (25 to 98 percent).” (Nadelman 2001) Yet in this study a patient was considered ‘cured’ if they did not develop a rash?
  6. The study relied on an antibody test that misses more than 50% of early Lyme. Exposing those patients to a single dose of antibiotics may have abrogated many of the test results. As stated on the CDC website: “Some people who receive antibiotics (e.g., doxycycline) early in disease (within the first few weeks after tick bite) may not have a fully developed antibody response or may only develop an antibody response at levels too low to be detected by the test.”
  7. The study only lasted six weeks and there was no follow-up blood work or clinical exam. beyond that. So, patients who developed late Lyme arthritis, or neurological manifestations of Lyme disease (including meningitis, encephalitis, myelopathy, cranial neuritis, neuropathy) were excluded.
  8. This study differs from three previous studies, which showed no benefit to antibiotic prophylaxis given after a tick bite. (Agre, 1993; Costello, 1989; Shapiro, 1992) Why does the Nadelman study outweigh the other three?
  9. Numerous studies demonstrate B. burgdorferi’s ability to survive a standard course of antibiotic therapy in animals and in humans.  (Aucott, et al., 2013;Fallon, el al., 2008; Feng et al., 2015; Hinckley et al., 2014; Hodzic et al., 2008;, Klemper et al, 2001; Sharma et al., 2015; Straubinger, 2000;S trle et al., 1993)  Why does the CDC think that a single dose of doxycycline, which doesn’t kill borrelia in a petri dish, would clear infection in humans?

In conclusion, I would ask that the Tick-borne Disease Working Group encourage the CDC remove the recommendation of Doxycycline prophylaxis until further proof exists of the ability for a single dose of Doxycycline to kill B. burgdorferi.

References:

Applegren ND, Kraus CK. (2017) Lyme Disease: Emergency Department Considerations. J Emerg Med,

Agre F, Schwartz R. (1993) The value of early treatment of deer tick bites for the prevention of Lyme disease. Am J Dis Child, 147:945-947

Aucott, J. N., Rebman, A. W., Crowder, L. A., & Kortte, K. B. (2013). Post-treatment Lyme disease syndrome symptomatology and the impact on life functioning: is there something here? Qual Life Res, 22(1), 75-84. doi:10.1007/s11136-012-0126-6

Barthold, S. W., de Souza, M. S., Janotka, J. L., Smith, A. L., & Persing, D. H. (1993). Chronic Lyme borreliosis in the laboratory mouse. American Journal of Pathology, 143(3), 959-971.

Cameron DJ, Johnson LB, Maloney EL. Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease from Expert Review of Anti-infective Therapy 2014 at https://www.tandfonline.com/doi/full/10.1586/14787210.2014.940900. (Last accessed 1/16/20).

Costello CM, et al. (1989) A prospective study of tick bites in an endemic area for Lyme disease. J Infect Dis 159:136-139

Ebner D., et al (2018) Cranial neuropathy and severe pain due to early disseminated Borrelia burgdorferi infection Case Reports 2018;2018:bcr-2017-223307.

Eisen, L. (2018) Pathogen transmission in relation to duration of attachment by Ixodes scapularis ticks. Ticks Tick Borne Dis. 9(3):535-542. doi: 10.1016/j.ttbdis.2018.01.002.

Eliza A.H. Little and Goudarz Molaei.Vector-Borne and Zoonotic Diseases. (Published online 2019) Ahead of print.  http://doi.org/10.1089/vbz.2019.2509

Elsner, R. A., Hastey, C. J., Olsen, K. J., & Baumgarth, N. (2015). Suppression of Long-Lived Humoral Immunity Following Borrelia burgdorferi Infection. PLoS Pathog, 11(7), e1004976. doi:10.1371/journal.ppat.1004976

Epidemiology and Prevention of Tick-borne Diseases in California. Information for Physicians and Other Health-Care and Public Health Professionals. Available at: https://www.cdph.ca.gov/Programs/CID/DCDC/CDPH%20Document%20Library/EpidemiologyandPreventionofTBDinCA.pdf Accessed:

Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease. National Guideline Clearinghouse. Agency for Health Care Research and Quality. Available from: https://www.guideline.gov/content.aspx?id=49320. (Last accessed 10/11/15).

Fallon, B. A., Keilp, J. G., Corbera, K. M., Petkova, E., Britton, C. B., Dwyer, E., . . . Sackeim, H. A. (2008). A randomized, placebo-controlled trial of repeated IV antibiotic therapy for Lyme encephalopathy. Neurology, 70(13), 992-1003. doi:10.1212/01.WNL.0000284604.61160.2d

Feng, J, Li T, Yee R, Yuan Y, Bai C, Cai M, Shi W, Embers M, Brayton C, Saeki H, Gabrielson K, Zhang Y. (2019) Stationary Phase Persister/Biofilm Microcolony of Borrelia burgdorferi Causes More Severe Disease in a Mouse Model of Lyme Arthritis: Implications for Understanding Persistence, Post-Treatment Lyme Disease Syndrome (PTLDS), and Treatment Failure. Discov Med 27(148):125-138.

Hinckley, A. F., Connally, N. P., Meek, J. I., Johnson, B. J., Kemperman, M. M., Feldman, K. A., . . . Mead, P. S. (2014). Lyme disease testing by large commercial laboratories in the United States. Clin Infect Dis, 59(5), 676-681. doi:10.1093/cid/ciu397

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Don Mau

Dear Tick-Borne Disease Working Group Staff;

I have a site which is NB protocol, the site specializes in immune system microbiology relative to vector borne Bartonella as the driving pathogen. I show scientific proof of how Bartonella specifically shuts off the immune system and provide working strategies to reverse that. For a very long time the strategy of identifying every particular infection a person has and then trying to kill that infection through chemical approaches has been accepted as just common sense. That flawed strategy ignores the fact that if a persons immune system was working as it should then that person wouldn't be sick. Focusing on the problems involved with the immune system yields positive results. There is no need to add detrimental toxic treatments that only complicate a persons biochemistry. I have pinned down the exact immune system problem and how to correct them. The mistake people are making is trying to treat the infections. Lyme/Bartonella shuts off the immune system to survive. Turning the immune system back on to remove infections is not that difficult. http://nbprotocol.proboards.com/thread/235/restoring-apoptosis.

Thank You,
Don Mau
Colorado Springs, Colorado

Winifred Mauga

To all committee members:

Lyme Conundrum

This disease is wrecking families, finances and futures. Will your endeavors lead to outcomes favorable for the most vulnerable immunocompromised stakeholders? Or will a lacadaisical response by the tick borne disease working group be associated with an even higher infection rate and no valuable cure?

To date, members have failed to send a clear message about the seriousness of tick-borne sepsis. It is far more than a slight cognitive decline, a relapsing fever or an arthritic knee. It is a systemic demise with high resistance to treatments which causes disability, severe morbidity, suicide, and death.

Loss of public confidence is evident. Uncertainty about this serious epidemic needs addressing. Transparency is paramount.

A thoughtful approach to wise leadership would be to First Define what the disease is. Second, revisit Dearborn and the fraudulent diagnostic testing standards which have alienated the sickest of patients. These fellow humans are denied adequate treatment, community support, compassionate medical care or insurance coverage. It is a crime against humanity.

Lyme and Vector-borne diseases do not discriminate. They are crippling babies in utero, maiming innocent children, victimizing elderly, sickening our military service members and disabling an untold numbers of citizens. When will this madness end?

The taxpaying public deserves an efficient, timely and complete public health initiative to overcome this insidious disease; Not another disease causing vaccine.

TBDWG members need to contemplate and attain the highest fiduciary standards possible. Let your actions, deeds, and words be anything but empty.

Respectfully,
Winifred Mauga

Kathleen Wallace

I became a Lyme Disease patient advocate after dealing with life changing consequences of exposure to Lyme. With my diagnosis of Lyme came Multiple Chemical Sensitivities (MCS). The life changing symptom lead to isolation and despair; a loss of quality of life.

I want to share with you, because we are still discovering surprising groups of sufferers of MCS; some with no obvious connections to ticks.

My passion to make a difference has grown through my journey. I was a successful business owner and manager for a national company whose name you would recognize. I lost my home, my business and my family life because of MCS.

MCS is a medical condition characterized by adverse health effects from exposure to common chemicals and pollutants from products such as pesticides, new carpet, paint, renovation materials, diesel exhaust, cleaning supplies, perfume, scented  laundry products and air fresheners.(1)

With MCS, we lose the ability to use public transportation, public housing or hotels. We are unable to participate in many community activities. The social impact is gruesome.

The symptoms of MCS are diverse and unique to each person. Symptoms range from mild to life-threatening and include headache, trouble concentrating, nausea, diarrhea, fatigue, muscle and joint pain, dizziness, difficulty breathing, irregular heartbeat, and seizures.(2)

Listen to these statistics; 12.8% of Americans are medically diagnosed with MCS and 25.9% self report. 86.2% experience health problems, 71% are asthmatic, 70.3% can not access places that use fragranced products, and 60.7% lost work days or a job due to fragranced products in the workplace.(1)

With MCS the quality of life is significantly degraded. Access to healthcare can be difficult as we have to tolerate hospital and office air.

I am member of a multitude of online support groups for MCS and Lyme Disease, it is quite clear that MCS is an underlying condition in the tick-borne disease community.

We share the symptom of MCS with Gulf War veterans and 9/11 survivors. We overlap.

The research advisory committee on Gulf War Veterans' Illness found similarities between Gulf War illness and multi symptom conditions in the general population. The committee focused on three defined syndromes; Chronic Fatigue Syndrome (CFS), Fibromyalgia (FM) and Multiple Chemical Sensitivities (MCS).(3,pg. 274) Parallels are commonly drawn between Gulf War illness and symptom defined conditions such as MCS found in the general population.(3, pg.15)

It's not just Gulf War vets who deal with MCS. In 2002, a US Senate Subcommittee held hearings on finding a link between World Trade Center air quality and development of MCS.(4)

The time has come to recognize MCS. We need a medical code. We need research. We need education for physicians. We need better air quality control.

I run a support group and have developed resources locally, but would like to see access to information expanded beyond my part of Upstate New York.

Thank you kindly for the privilege of sharing.I am here to serve.

Sincerely,
Kathleen Wallace
Upstate New York Lyme Disease Association

  1. Dr. Anne Steinemann journal of Occupational and Environmental Medicine, March 2018 volume 60 Issue 3 pg 152-156.
  2. Anne McCampbell, M.D. Co -chair of the MCS task force of New Mexico. New Mexico MCS brochure by the MCS task force of New Mexico 11/00
  3. Research Advisory Committee on Gulf War Veterans' Illness .Gulf War Illness and the Health of Gulf War Veterans: scientific findings and recommendations Washington D.C. November 2008.www.va.gov/Rac-GWVI.
  4. Senate subcommittee chaired by Senators Joe Lieberman and Hillary Clinton on Clean Air, Wetlands, and Climate Change hearing. Impacts on Air Quality of the September 11th Attacks and Possible Health Effects in the Area of the World Trade Center. February 11,2002. Dr. Steven Levin of the Mount Sinai School of Medicine. Alison Johnson, chair of the Chemical Sensitivity Foundation testimony at the World Trade Center air quality hearing held in lower Manhattan by U.S. EPA Ombudsman Robert Martin on February 23,2002.

Footnotes:

Among generally representative groups of Gulf War Veterans , 13-17% endorse the symptom of being sensitive to chemicals or odors.3, pg. 280)

Results from studies of Gulf War Veterans show the health outcome of MCS on multiple listings and findings.(3, pgs. 401,403,408,412,415,419,424,429)

Kathy White

Dear Working Group,

Please make Lyme disease your top priority. It is having a greater impact on the health of our society than all the other vector-borne diseases. Lyme disease is disabling many children and adults, causing people to be too tired to work or go to school, causing psychiatric and cognitive problems that make it difficult for a person to function, and causing such intense headaches and other pain that some patients are on narcotics, but even narcotics don’t make the pain go away completely. Some Lyme patients commit suicide. Many others attempt or contemplate suicide if they can’t get relief from their pain and depression.

We need research to find a reliable test for Lyme disease. Current tests miss many cases and allow patients to develop chronic symptoms which may last a lifetime. The CDC estimate of 300,000 cases a year are of people getting diagnosed with Lyme disease. Diagnosis is so difficult that there could be a half-million to over a million people actually becoming infected with Lyme disease each year, many of whom may never get diagnosed correctly. Women who are undiagnosed and untreated are giving birth to children who are born with Lyme disease.

We need research to find the best treatments and treatment protocols for Lyme disease. My doctor thought two weeks of doxycycline was enough. I was improving with the treatment but was still very ill, so I persuaded him to prescribe a third week of treatment. I continued to improve that week but was still ill, but I could not convince him to give me a 4th week of treatment. I became very ill that 4th week, and I became numb all over. I’m still numb all over now, 21 years later. Profound fatigue caused me to quit my teaching job, and I never did get well enough to return to work.

There is some evidence that Lyme disease may be sexually transmitted. More research is needed to determine whether and to what extent this may be happening. Animal studies indicate that Lyme disease may be transmitted through breast milk. We need research funding to determine whether this is happening in humans.

There are many things we don’t know about Lyme disease. Since this disease has the potential to put many people on Social Security Disability, SSI, Medicaid, and Medicare, food stamps, special education services, and in public housing, and can result in loss of income tax revenue by making many Americans (and eventually many of their offspring) too ill to work, it would be wise to appropriate a massive increase in funding to find better tests, better treatments, and better prevention strategies for Lyme disease.

Sincerely,
Kathy White
Overland Park, KS

Kathy White

Dear Tick-Borne Disease Working Group,

Lyme disease is the most frequently reported tick-borne disease in the United States. It needs to be the top priority in tick-borne disease research funding, since it is the most frequently reported tick-borne disease and is disabling many Americans and putting children and adults in wheelchairs.

Most cases of Lyme disease are not getting reported. As you know, the CDC estimates that over 300,000 people in the U.S. are being diagnosed and treated for Lyme disease every year. However, many, perhaps most, cases are not getting diagnosed. Many patients go from doctor to doctor for years and see 10-30 doctors before getting diagnosed. One child in Colorado saw 51 doctors before she finally got diagnosed and treated for Lyme disease. A survey conducted by Lymedisease.org of several thousand patients with chronic Lyme disease found that 72% of them were initially misdiagnosed with something else. For 47% of the chronic Lyme patients, it took two or more years before they got diagnosed correctly.

Lyme disease poses a financial burden on our country, which will only increase as the disease continues to disable more people. Many people with Lyme disease become so ill they have to quit work or school. Adults may miss years of work or may never become well enough to return to work, which results in decreased income tax revenue for the government. Many Lyme patients need Social Security Disability Income, SSI, Medicare, Medicaid, and/or food and housing assistance. Many children need special education services or home instruction. People in the military are getting tick bites, and some become disabled by Lyme disease and need the services of government health insurance and the VA.

Lyme disease has the potential to disable our society. More and more people are becoming disabled by it every year. The disease is not just impacting the person who gets the tick bite. Children are being born with this disease. Researchers have found Lyme disease bacteria in the placentas and umbilical cords of children born to mothers who have Lyme disease. We know of families who have several children born with Lyme disease before the mother finally gets diagnosed with the disease. We know of three families where the disease likely was transmitted to the third generation. The children got diagnosed, and then the mother, and then the grandmother learned that the health problems she had for many years were caused by Lyme disease.

Lyme disease is disabling many more Americans than HIV/AIDS, West Nile virus, Zika virus, and breast cancer, yet these diseases have received much more government research funding. It’s time to provide a proportionate amount of funding for Lyme disease to prevent it from disabling people now and in future generations. We need more research to find a reliable test for Lyme disease. We need research funding to find what treatments and treatment protocols work best for chronic Lyme disease. We need a cure.

Sincerely,
Kathy White
1st Vice-President, Lyme Association of Greater Kansas City, Inc.

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