TBDWG June 21, 2018 - Meeting Summary

Welcome and Roll Call / What Has Been Occurring Since Meeting 5
Public Comments
Discussion of Already Submitted Public Comments
Discussion of Inventory
Discussion of a Transparency and Innovation Subcommittee
Discussion of the Outline for the Report to Congress and the HHS Secretary
Epidemiology and Ecology Chapter Discussion
Prevention Chapter Discussion / Diagnosis Chapter Discussion / Treatment Chapter Discussion
Access to Care, Patient Outcomes Chapter Discussion
Discussion of Images and Infographics to Be Included in the Working Group Report to Congress
Discussion of Topics for Technical Issue Briefs / Review of Meeting 6, Next Steps
Closing Remarks and Adjournment / Appendix: TBDWG Members and HHS Staff

Note: For context and clarity, speaker credentials will be included upon first mention in each meeting’s summary. Subsequently, individuals will be referenced by their first names to equalize expertise across the many diverse disciplines represented in this document. All perspectives and expertise, including patient-lived experience, is valued equally. Speaking on a first-name basis helps the Tick-Borne Disease Working Group ensure that all voices are heard and valued based on merit and without the bias of titles, eminence, or prestige.

Welcome and Roll Call

John Aucott, MD, Associate Professor, Division of Rheumatology, Johns Hopkins University School of Medicine; Director, Johns Hopkins Lyme Disease Clinical Research Center; Working Group Chair, welcomed participants to the meeting and conducted roll call (see Appendix: Working Group Membership for attendance). The meeting started with a quorum.

John expressed appreciation to the virtual audience for their participation and interest. He also thanked the subcommittee members who had been an invaluable resource to the last meeting and to the development of the working groups’ recommendations.

Kristen Honey, PhD, PMP, Innovator in Residence, Office of the Chief Technology Officer, Immediate Office of the Secretary, U.S. Department of Health and Human Services (HHS); Member, Stanford University Lyme Disease Working Group; Working Group Vice Chair, took a moment to announce her new position at HHS.

Overview of What Has Been Occurring Since Meeting 5

John provided a summary of the working group’s activities since Meeting 5 on May 15 and May 16, 2018. The working group’s primary focus had been the writing of the report to Congress and the HHS Secretary. He stated that they had divided themselves into writing groups, each of which was devoted to writing one of the following chapters:

• Epidemiology and Ecology
• Prevention
• Diagnosis
• Causes and Treatment
• Access to Care

John noted that the bulk of the previous month had been spent determining how to address the more controversial issues in the report. However, he also clarified that each chapter contains information about the many areas of agreement, which include prevention, diagnostics, treatment of Lyme disease (acute and chronic) and other tick-borne diseases, education, patient access to care, the need for tick and human disease surveillance, and the need for more research and science about the pathogenesis of tick-borne diseases.

John stated that the working group had been busy writing text, sending it back and forth for revision, and working to balance the many diverse opinions about the recommendations approved at the last meeting. They had also been reviewing public comment and conducting a cursory overview of the inventories received thus far. Based on this public comment and inventory review, John noted that the members had developed new recommendations.

John then reaffirmed Tick-Borne Disease Working Group’s shared vision, mission statement, and core values, outlined below.

Shared vision: A nation free of tick-borne diseases where new infections are prevented and
patients have access to affordable care that restores health.

Mission statement: The Tick-Borne Disease Working Group’s mission, as mandated through the 21^st Century Cures Act, is to provide expertise and to review all efforts within the Department of Health and Human Services related to all tick-borne diseases, to help ensure interagency coordination and minimize overlap, and to examine research priorities. As part of this mandate, and in order to provide expertise, we will ensure that the membership of the working group represents a diversity of scientific disciplines and views and is comprised of both federal and non-federal representatives, including patients, and family members or caregivers, advocates of non-profit in the interest of the patient with tick-borne disease, clinicians, scientists and researchers. A major responsibility of our mission will be to develop and regularly update the action of HHS from the past, present and the future.

Core values:

1. Respect: Everyone is valued
2. Innovation: Shifting the paradigm, finding a better way
3. Honesty and Integrity: Find the truth, tell the truth
4. Excellence: Quality, real-world evidence underlies decision-making
5. Compassion: Finding solutions to relieve suffering
6. Collaboration: Work with citizens and patients as partners
7. Accountability: The buck stops here

Before moving on to public comment, John outlined the goals for Meeting 6. This included reviewing the high-level organization of the draft report to Congress and the HHS Secretary, which would be presented in a PDF file containing the recommendations the group had already voted on and approved, as well as dummy copy to show how the chapter content would ultimately be placed. John stated that the working group would also be looking at figures for the report, as well as discussing the public comment and inventory review and, finally, voting on the new recommendations that resulted from that process.

Public Comments

Seven members of the public provided comments to the working group.

John Barrett: John stated that he was diagnosed with Lyme disease in 2000 after living with the illness for at least 20 years without a diagnosis. He had been the vice-president of a bank but was forced to accept disability due to deteriorating health. According to John, his insurance company would not cover his medical costs, causing him to spend much of his life savings on treatment. He specified that he is in continual discomfort with symptoms ranging from difficulty sleeping to muscle and joint pain to cognitive impairment. He also indicated that he had transmitted Lyme disease to his wife who then transmitted it to their child in utero. John described the current system for diagnosing and treating Lyme disease as inadequate and stressed the need for a system overhaul.

Lorraine Johnson: Lorraine described the process of shared medical decision making, whereby patients collaborate with their physicians by “discussing the risks and benefits of different diagnostic and treatment options available to determine the best approach to individualized care.” She stated that this process is frequently used when science is uncertain, and there are quality-of-life consequences to the treatment options, as is the case with cancer patients. She noted that her organization, LymeDisease.org, believes shared medical decision making is essential for Lyme disease. However, she added, only the International Lyme and Associated Diseases Society (ILADS) guidelines promote this practice; whereas the Infectious Diseases Society of America (IDSA) guidelines restrict the use of clinical judgment and “leave patients without treatment options when short-term therapy fails.” Lorraine urged the working group to recommend.

• that government agencies provide unbiased information regarding both standards of care;
• that physicians inform patients about the risks and benefits of different treatment options in the context of shared medical decision making and individualized care; and
• that insurance reimbursement be available for treatment under either standard of care.

Brooke Mullins: Brooke stated that in 2014, she experienced psychiatric symptoms that resulted in her being briefly admitted to a mental health facility, and the results of her blood tests at that time were highly irregular. She added that in 2015, she gave birth to a boy with significant health issues. According to Brooke, the boy displayed reduced kidney function in the womb, and since birth, he has experienced poor weight gain, delayed milestones, lack of coordination, and gastro-esophageal reflux disease. She expressed her suspicion that he has undiagnosed neurological damage, which has resulted in his inability to feel pain as evidenced by significant self-harm, including pulling off his fingernails, pulling out his teeth, and biting his tongue in half. She conveyed her belief that both her illness and her son’s poor health are the result of tick-borne disease; however, she noted, “no one will listen to me because they don’t believe me.”

Marina Carboni: Marina described her sister as healthy and athletic until she developed a high fever and rash. Marina stated that her sister was told that 10 days of antibiotics would treat Lyme disease if that was what she had. While her sister appeared to recover at first, Marina indicated that her health deteriorated over the next few years. According to Marina, her sister’s doctors would not reconsider her prior fever and rash; instead, they treated her for hyperthyroidism. Her sister continued to experience severe pain, an inability to remember basic tasks, and digest simple foods. Marina stated that her sister finally tested positive for Lyme disease and babesiosis, but that she ultimately lost her life at the age of 39. Marina urged the working group to make recommendations that call for

• funding research in an effort to provide adequate testing at all stages of infection and to understand what medical treatment is necessary, including for late stage infection; and
• educating the medical community about the seriousness and potential persistence of tick-borne diseases.

Aliza Yarden-Cummings: Noting that she was struggling to coordinate words and speak, Aliza read from a script in which she described herself as an organic farmer and alpha-gal survivor who is still living with the effects of encephalitis caused by a Lone Star tick bite in April 2018. Following her first anaphylactic reaction to red meat, she was treated with antibiotics and antivirals for encephalitis; however, she stated, the doctors refused to consider the tick bite that her husband and friend mentioned to them. She indicated that only after the second severe allergic reaction did her doctor conduct an alpha-gal test, the results of which were positive. According to Aliza, she has since had a third reaction to her garden soil containing horse and goat manure. She stressed that alpha-gal syndrome is a life-threatening condition and that health care professionals and the public need to be educated about it.

Allison Caruana: Allison discussed the morphological commonalities between several tick-borne diseases and other organisms that “harbor symbiotic colonies of mutant viruses.” She stated that tick-borne pathogens, such as rickettsia and mycoplasma, were manipulated in the early twentieth century.  And she urged the working group to “allow doctors and scientists to speak about what they know about the rapidly expanding order of the ‘ales’ and the impact it is having on the bacteria that go across many kingdoms.”

Beth Carrison-van der Heide: Beth noted that she was speaking on behalf of Christina Targaczewski and the alpha-gal community. She referenced a study conducted by Dr. Colleen McNamara that links alpha-gal syndrome to a buildup of plaque in the arteries. Beth quoted Dr. McNamara as saying that the “allergen…is estimated to impact roughly 1% of the U.S. population; however, it may affect as much as 20% of the population in certain areas, especially where the Lone Star tick is prevalent.” Beth stated that there is a connection between hardening of the arteries and periodontal disease. Therefore, she urged the working group to recommend further research into the “full body effect” of alpha-gal syndrome and other tick-borne diseases, specifically the cardiological, dental, and neurological effects. She asked that the committee assist in recommendations for physicians regarding common protocols for medications and treatments to ensure they become safe for alpha-gal patients as many medications contain mammalian-derived ingredients. She also stressed the need for effective repellants and enhanced safety of medications and treatments for alpha-gal given that many of them contain mammalian products.

Discussion of Already Submitted Public Comments

John transitioned the discussion to Kristen and Robert (Bob) Sabatino, Founder and Executive Director of Lyme Society Inc., to discuss previously submitted public comments. Kristen thanked everyone for their in-person comments and written submissions. She then described the two types of written public comments – one type submitted to the tick-borne disease email site specific to the public meetings and posted on the tick-borne disease website and another type submitted to the tick-borne disease email site for all other comments related to the Working Group and its activities. She noted that after personally identifiable information is removed for the second type of written comment, the comments are made available to all working group members for review. However, she clarified, she and Bob were the ones to read each and every comment in order to produce the summary that they were about to present.

• Kristen stated that out of the 1,200 emails received, she and Bob identified the following major takeaway: Lyme disease and tick-borne diseases are not being addressed sufficiently by mainstream medicine and government programs today. This warrants increased research funding, further scientific exploration, and unbiased and fresh review of the latest information from across all disciplines and sectors.

Kristen then described the quantity and quality of the public comments. In terms of quantity, she indicated that 95% of the comments came from patients, loved ones, advocates, physicians, and researchers who requested increased government attention, more funding, fresh eyes, and an honest perspective that engages new disciplines and new people for 21^st century cures. She noted that many of those individuals took positions against the short-term use of antibiotic therapies and dogmatic scientific approaches to treatment. She added that less than 5% said there was no disagreement about Lyme disease and that current diagnostics are accurate. According to those commenters, Kristen clarified, the problems relate to the over-diagnosis of Lyme disease, treating people for a disease they may not have when they are sick with something else, and the side effects associated with antibiotics. By quality, about 20% were written in terms of arguments that were logically laid out with well cited sources, such as peer-reviewed studies, white papers, grants, and data sets from specific government programs. These submissions generally supported the 5% of submissions that current diagnostics are accurate.  Bob noted that the majority of comments were from patients and their family members who were largely positive and supportive of both patients and the efforts of the working group.

Kristen and Bob then presented the comments as themes related to each chapter of the working group’s report to Congress. (See outline below.) Kristen noted that most of the new recommendations that would be discussed resulted from the public comment.

Epidemiology and Ecology

• Include at least three tick experts, entomologists, and/or vector biologists on the Tick-Borne Disease Working Group and its subcommittees.
• Fund comprehensive cost-of-illness studies that capture direct (such as diagnosis, prescriptions, doctor visits) and indirect medical (such as lost work, travel to and from doctor), as well as tertiary costs (for example, loved ones taking time off to care for the patient).
• Have the Centers for Disease Control and Prevention (CDC) update its tick distribution maps and report cases of Lyme and other tick-borne diseases from all 48 states of the continental U.S.
• Have the CDC revert to weekly (not annual) official statistics for Lyme disease in the Morbidity and Mortality Weekly Report (MMWR) summaries of notifiable diseases.

Kristen clarified that the fourth bullet point was not put forward as a recommendation because Lyme disease bacteria grows slowly so reporting tends to lag behind the actual incidence, and thus reporting data on a weekly basis lacks reliability. Therefore, the working group put forth a recommendation for enhanced disease and tick surveillance.

Prevention

• Education is a vital component of prevention.
  • Many “do not want another failed attempt at a vaccine” and mentioned Trust was lost following the 1994 Dearborn conference and events involving LYMErix
  • Commenters were particularly concerned about the FDA fast-tracking vaccines with some public comments perceived to be industry prioritizing profits over safety and efficacy. Others stated that a safe and effective vaccine is needed, but safety has to be the priority.
• Because vaccine development takes a long time, short-, medium-, and long-term actions are needed
• Prevention should be the first step because it has the highest payoff and is something that can be done today.

Diagnosis

• Lyme disease is diagnosed by a combination of medical history, physical exam, and if needed, diagnostic testing. Diagnostics should not be the sole method used.
• Include a table or image in the report that identifies the pros and cons of currently available testing, especially serology, and diagnostics. The table could serve to educate physicians and patients.
• Partner with other stakeholders for lessons learn and best practices, such as with other disciplines, states, and countries:
  • In Canada and England, a tick-borne disease test panel is part of standard, base-line care for a medical check-up.
  • Explore next generation technologies used for other diseases or in different disciplines for possible application to tick-borne diseases.
  • Consider partnerships at the state level, for example with the New York State Department of Health, to create a national proficiency test program for tick-borne borreliosis.

Cause and Treatment

• Need to determine whether or not a Lyme disease infection is active or resolved. A positive result to the antibody test indicates someone has been exposed, but the test does not indicate if it is an active infection or occurred many years ago.
• Important to support an integrated, interdisciplinary systems biology approach to better understand tick-borne diseases and related immune suppression for the cascading effects that occur due to the illness or exposure.
• Much of Western medicine is siloed and ill-equipped to address complex systems across multiple, integrated systems. Today’s medical construct of Lyme disease and tick-borne disease must be revised to match the science.
• More research is needed in the areas of other tick-borne diseases, coinfections, combinations of coinfections, and alpha-gal syndrome related to the Lone Star tick.

Patient Access to Care

• Insurance should cover treatment, including long-term antibiotics and immunotherapy. Treatment should be patient-centered and at the treating clinician’s discretion.
• Patients should be able to work collaboratively with their providers to make decisions about their course of treatment, weighing risks and benefits similar to options available to cancer patients.
• Current medical practice is often harmful to already traumatized patients who are struggling to survive; medical professionals often do not believe patients are physically ill.
• Medical training about tick-borne diseases should be more at the forefront, particularly for family practitioners and emergency room staff.
• Suicide is high among Lyme disease and tick-borne disease patients, given how they are treated or not treated in today’s system
• For the report, include language about working with mental-health professionals on neuroborreliosis and the mental health implications of Lyme disease which can sometimes manifest as psychiatric symptoms; take extra care to avoid victim blaming.
• Address special populations, including children, pregnant women, veterans, service members, migrant workers, farmers, hunters, and outdoor enthusiasts.  More than 40 percent of new cases of Lyme disease are children.
• Comprehensive cost-of-illness studies are needed to show the full burden to society.
• Evidence-based care and policies are needed based on rigorous scientific evidence.
• Patients urgently need help now.

Kristen noted that there were many public comments related to the working group’s process for completing its work. She detailed that the public asked for the administrators at the HHS to be more prompt in responding to emails, posting announcements and meeting minutes, and updating the Tick-Borne Disease Working Group website. She also noted that public commenters called for increased transparency, and they encouraged the working group to address complex, thorny issues head-on and without delay.

At this time, Kristen made a motion to create a new subcommittee on transparency and innovation that will engage with patients and patient advocates and explore how patient partnership and patient illness is not just an ethical and moral imperative that can move this process forward. She then asked for volunteers to serve on the committee, and several members agreed. Other members wanted to discuss the motion further before voting on it; therefore, the working group agreed to discuss it later in the meeting.

Discussion of Inventory

John transitioned the meeting to Chinedu Okeke, Senior Policy Advisor, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, to discuss the preliminary results of the inventory requests from the CDC, the National Institutes of Health (NIH), the Department of Defense (DoD), the Centers for Medicare and Medicaid Services (CMS), and the U.S. Department of Veterans Affairs (VA).  Chinedu pointed out that through the 21 Century Cures Act, the Working Group was created in part to review all efforts within HHS as it relates to tick-borne diseases; ensure agency coordination and minimize overlap; and identify risk factors, research priorities, and gaps.

Chinedu stated that the working group had received inventories from all of the agencies; however, the CMS and the VA showed no activities related to tick-borne diseases. In contrast, he noted that the CDC and the NIH address all focus areas of the working group except access to care, and the DoD addresses issues related to disease vectors and surveillance, as well as vaccines. He added that the CDC and the DoD have strategic plans for addressing tick-borne diseases.

Chinedu outlined the following information related to the inventories.

• Conducts human surveillance: CDC, NIH
• Conducts animal surveillance: CDC, NIH, DoD
• Total past and current projects for fiscal years 2010 through 2018: 1,493
  • CDC: 69
  • NIH: 1274
  • DoD: 150
• Total publications for fiscal years 2010 through 2017: 743
  • CDC:467
  • NIH:235
  • DoD: 41
• Approximate General Funding FY 10 - 18: $507 M
  • CDC - $52.1 M (FY 13-18)
  • NIH - $426.5 M (FY 10-17)
  • DoD - $28.4 M (FY 10-18)

Chinedu then provided a sampling of the research gaps identified by the agencies. These included

• improving early and accurate diagnosis and treatment,
• strengthening national surveillance,
• understanding the immunological mechanism (pathogen-host interaction) of immune protection for Lyme disease or other tick-borne diseases,
• advancing new rapid and accurate lab tests, and
• developing antibiotic combinations and/or therapeutic options for treating acute and persistent illness.

John concluded the discussion by clarifying that the working group had not yet conducted a complete analysis of the inventories. Kristen added that the working group members all have access to the full responses.

Discussion of a Transparency and Innovation Subcommittee

Following their lunch break, the working members revisited the motion Kristen had proposed earlier in the day. She provided it to the group in writing as follows:

• Create a Transparency & Innovation Subcommittee to further support HHS transparency, responsiveness, and innovation efforts, specifically by engaging directly with all stakeholders—including the Lyme disease and tick-borne disease patients and advocates—in order to co-create solutions, together, and translate this information into recommendations for the Working Group. We will leverage open data, open science, and open innovation (e.g., crowdsourcing, citizen science, prizes, challenges, and innovative public-private partnerships) to accelerate next-gen solutions and alleviate suffering today.

The members asked for clarification about the timeline, membership, deliverables, and expectations for the proposed subcommittee. They also discussed the possibility of forming an ad hoc committee rather than a subcommittee in order to stay within the Federal Advisory Committee Act (FACA) regulations. One member expressed confusion about the innovation part of the motion, which she stated would be closely related to the work of the subcommittees. Following this remark, the group agreed to strike the second half of the motion in order to focus exclusively on transparency of process.

Some members continued to express uncertainty, and ultimately, a motion was passed to table the following motion until Meeting 7 in July of 2018:

• Create a Transparency & Innovation Subcommittee to further support HHS transparency, responsiveness, and innovation efforts, specifically by engaging directly with all stakeholders—including the Lyme disease and tick-borne disease patients and advocates—in order to co-create solutions, together, and translate this information into recommendations for the Working Group.

Voting Results: Eleven of the 12 members present voted yes, and one voted no. Two members were absent.

Discussion of the Outline for the Report to Congress and the HHS Secretary

John presented the working group members with the report’s table of contents, which included the following sections:

• Executive Summary of the Tick-Borne Disease Working Group
• Background
  • Statement of the Problem
  • Congressional Action
  • Establishment of the Working Group
• Methods for the Working Group
• Epidemiology and Ecology
• Prevention
• Diagnosis
• Cause and Treatment
• Access to Care, Patient Outcomes
• Looking Ahead
• Conclusion

During their discussion of the table of contents, some members expressed concern that the term “Cause” may overstate what will actually be covered in the report. The group therefore decided to rename the chapter “Treatment” without reference to cause.

Kristen then reported that many of the chapters have patient stories that reinforce a theme within the chapter.  She presented the group with the following patient story, which she indicated would be featured in the Background section of the report.

• Ruben Lee Sims is a Vietnam veteran who served our country, earning the Vietnam War Campaign Ribbon and was recognized as the “USAF Comptrollers Top Enlisted Management Analyst of the Year” in 1977. Five years later, multiple tick bites derailed life as he knew it. The U.S. Department of Veterans Affairs (VA) was not equipped to diagnose Lyme disease. The military discharged Mr. Sims in 1984 due to “hypochondriasis with psychogenic pain disorder.” In 1985, a non-military doctor in San Diego was close to diagnosing Lyme disease, but since Mr. Sims had not traveled to New England, the doctor said that the symptoms cannot be caused by Lyme [disease. The psychogenic pain is now confirmed Lyme disease, based on a VA diagnosis—34 years later. With proper diagnosis and treatment, physical and mental symptoms resolved. He shares his story to reach veterans, especially homeless veterans who may be affected by tick-borne diseases.

Kristen provided context for why the story was chosen for inclusion in the report. Reasons included Mr. Sims’s misdiagnosis for 33 years by the VA; his deteriorated mental health; his homelessness resulting from financial strain caused by Lyme disease; his inability to work without treatment; and the resolution of his symptoms, both physical and mental, with proper Lyme disease diagnosis and treatment. Kristen added that Mr. Sims represents diversity of race and disease presentation, and he is part of a vulnerable population.

In discussing the patient story, some members stressed the importance of including stories about patients who have been successfully diagnosed and treated in order to provide a balanced representation of the patient experience.

The working group members then conducted a vote to include Ruben Lee Sims’s story in the Background section of the report to Congress and the HHS Secretary.

Voting Results:  All members present (13) voted yes. One member was absent.

John then transitioned the meeting to presentations of the recommendations in each chapter of the report. He noted that most of the recommendations that had been voted on and approved at Meeting 5 were unchanged; however, the group would be voting on recommendations that had been revised since then or newly created in response to the public comment and preliminary results of the federal inventory. He added that minority opinions would be presented as well, but only for review as they had been already discussed fully at Meeting 5.

Epidemiology and Ecology Chapter Discussion

John turned the meeting over to Kristen, who presented the Epidemiology and Ecology chapter. Kristen read the following recommendations, which had been voted on and approved at Meeting 5. She noted that the first recommendation was unchanged and did not need to be put up for a vote; however, the second and third recommendations contained revised wording and would require a vote.

• Approved 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.
• Revised Recommendation: Have public health authorities formally recognize alternative, validated systematic approaches to tick-borne disease surveillance for humans, such as systematic sampling of tick-borne disease reports for investigation, that reduce the burden on tick-borne disease reporters but allow for comparability of surveillance findings across states and over time. (Agree on intent, not exact language.)
• Revised Recommendation: Public health authorities shall annually and when opportune (such as during Tick-Borne Disease Awareness Month) inform doctors, insurers, state and local health departments, the press and the public through official communication channels, that the Lyme disease surveillance criteria are not to be used solely for diagnostic purposes.

Kristen then presented two new recommendations that were developed based on public comment and results of federal inventory review. The rationale for the first recommendation was that six new tick-borne pathogens were discovered in the past 13 years and an exotic tick was identified in the U.S. recently, which was the first new tick identified in the U.S. in the past 50 years. In Asia, this tick is a host for many pathogens.

• New Recommendation: Fund systematic studies and activities to identify and characterize novel tick-borne disease agents in the United States.
• New Recommendation:  Fund economic studies and activities to estimate the total cost of illness associated with tick-borne diseases in the United States, beginning first with Lyme disease and including both financial and societal impacts.

Following a brief discussion about research gaps, the working group voted to include the following recommendation in the Epidemiology and Ecology chapter of their report to Congress and the HHS Secretary.

• New Recommendation: Fund systematic studies and activities to identify and characterize novel tick-borne disease agents in the United States.

Voting Results: All members present (12) voted yes. Two members were absent.

The group then discussed the second new recommendation. Specifically, they asked questions about what type of data would be captured in total cost of illness studies; what the inputs would be when the true incidence of tick-borne disease is unknown; and how this recommendation would be prioritized amongst the others. Given how poorly characterized tick-borne diseases are, the group decided to change “Fund” to “Support” to encourage a broad look at the diseases and to leave room for the possibility that independent agencies might conduct the studies rather than the Federal government.

The working group voted to include the revised wording in the new recommendation as follow.

• New Recommendation:  Support economic studies and activities to estimate the total cost of illness associated with tick-borne diseases in the United States, beginning first with Lyme disease and including both financial and societal impacts.

Voting Results: All members present (13) voted yes. One member was absent.

Kristen then asked the group to consider the revised language of the following recommendation, which was voted on and approved at Meeting 5.

• Revised Recommendation: Have public health authorities formally recognize complimentary, validated systematic approaches to tick-borne disease surveillance for humans, such as systematic sampling of tick-borne disease reports for investigation that reduce the burden on tick-borne disease reporting but allow for comparability of surveillance findings across states and over time.
• Former Language: Have public health authorities formally recognize alternative, validated systematic approaches to tick-borne disease surveillance FOR HUMANS, such as systematic sampling of tick-borne disease reports for investigation that reduce the burden on tick-borne disease reporters but allow for comparability of surveillance findings across states and over time.

Following a brief discussion about the inclusion of vet reports from LymeDisease.org’s MyLymeData project in the report, the working group voted on the above revised recommendation.

Voting Results: All members present (13) voted yes. One member was absent.

Next, Kristen asked the group to consider the revised language of the following recommendation, which was also voted on and approved at Meeting 5.

• Revised Recommendation: The Lyme disease surveillance criteria are not to be used ALONE for diagnostic purposes; public health authorities shall annually and when opportune (such as during Tick-Borne Disease Awareness Month) communicate this and inform doctors, insurers, state and local health departments, the press, and the public through official communication channels including the CDC’s Morbidity and Mortality Weekly Report (MMWR).
• Former Language: Public health authorities shall annually and when opportune (such as during Tick-Borne Disease Awareness Month) inform doctors, insurers, state and local health departments, the press and the public through official communication channels, that the Lyme disease surveillance criteria are not to be used SOLELY for diagnostic purposes.

Following a brief explanation of the changes, the group agreed to vote on the above revised recommendation.

Voting Results: All members present (13) voted yes. One member was absent.

After noting that there were no minority opinions in the Epidemiology and Ecology chapter, Kristen moved on to discuss the inclusion of Dr. Neil Spector’s patient story as follows.

• Neil Spector, MD, is an oncologist and cancer researcher, who had a near-death experience with Lyme disease. Dr. Spector was an outdoor enthusiast and marathon runner in New England, a highly endemic area for Lyme disease. He first began having health issues, including arrhythmia and arthritis pain, in the early 1990s. Symptoms worsened with time and included cardiac rhythm disturbances, arthritis, muscle pains, and weight loss. When he was prescribed antibiotics for an unrelated condition, his symptoms improved. His Lyme disease diagnosis was confirmed in 1997. As a patient with Lyme carditis, Dr. Spector underwent a heart transplant to save his life.

Kristen explained why the story was chosen for the report. She said that it demonstrates the seriousness of Lyme disease and tick-borne infections, which can be fatal; and also how a healthy, outdoor lifestyle can increase exposure risk. She also noted that, despite being a doctor, he was misdiagnosed for many years and ultimately required a heart transplant because of Lyme carditis.

In discussing the patient story, one working group member expressed concern that the stories proposed so far are exceptional and not representative of the majority of tick-borne disease patients. The member stated that of the 300,000 cases of Lyme disease, most recover and felt it was important to provide a fair picture of the disease. To address this issue, there was a general consensus that the report would include counterbalancing information: for the Neil Spector story, this would include a box with facts about Lyme carditis and its rate of occurrence.

The group then voted on the inclusion of the Neil Spector’s patient story in the Epidemiology and Ecology chapter.

Voting Results: All members present (12) voted yes. Two members were absent.

While considering the need for a more balanced presentation of patient stories, the working group also voted to counterbalance the Ruben Lee Sims story with a story of a patient who was successfully diagnosed and treated for a tick-borne disease.  It was stated that when Lyme disease is caught early, most patients respond to short-term antibiotic treatment being successful.

Voting Results: All members present (12) voted yes. Two members were absent.

Prevention Chapter Discussion

John and Dennis Dixon, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services, presented the Prevention chapter. Dennis began by reading the following recommendations, which had been voted on and approved at Meeting 5.

• Approved Recommendation: Build trust—Transparent mechanism by which all stakeholders examine and discuss past vaccine activities and potential adverse events to inform future vaccine development in Lyme disease.
• Approved Recommendation: Support safe and effective human vaccines to prevent Lyme disease with transparent mechanism by which all stakeholders examine and discuss past vaccine activities and potential adverse events to inform future vaccine development in Lyme disease.

John then read the following two recommendations, which had also been voted on and approved at Meeting 5. He noted that both recommendations were originally proposed by the Disease Vectors, Surveillance, and Prevention Subcommittee, but had since been moved into the Prevention chapter.

• Approved Recommendation: Fund additional studies and activities on the development and evaluation of novel and traditional tick control methods that have shown promise in other areas of public health entomology.
• Approved Recommendation: Education—Inform clinicians and the general public of regional and specific risks related to tick illnesses.

John added that they were not proposing any new or revised recommendations. He then introduced Patricia (Pat) Smith, President, Lyme Disease Association.  Pat then stated her minority opinion for the Prevention chapter entitled “Learning from Vaccine History First,” which was developed on behalf of those who voted against the recommendation to support a human Lyme disease vaccine.

Finally, Dennis stated that instead of a patient story in the Prevention chapter, there would be a table containing the following information.

Table 1: How Vaccines Can Potentially Prevent Lyme Disease

• Rodent Targeted Vaccines
  • Kill the spirochete in ticks that feed on mice
  • Reduce the prevalence of infection among ticks and mice in the treated environment
• Human Vaccines
  • Osp-A-Based Vaccines
    • Block transmission of Borrelia burgdorferi by killing the spirochete in ticks
  • Osp-A-/OspC-Based Vaccines
    • Block transmission of B. burgdorferi by killing the spirochete in ticks and mammals
• Anti-Tick Vaccines
  • Neutralize the tick’s attachment proteins that facilitate a blood meal, which impairs tick feeding
  • Target the tick’s immunomodulatory proteins that affect host immune response, which:
    • Reduces transmission and/or acquisition of the causative organism
    • Reduces or partially controls the spirochete load
    • Impairs tick feeding
  • Target allergy or physiology proteins that facilitate tick engorgement or regulate important functions, which impacts pathogen transmission

In discussing the table, the working group agreed to add “and other species” after the references to B. burgdorferi so as not to limit the potential for vaccines. They then conducted a vote to include the table in their report.

Voting Results: All members present (12) voted yes. Two members were absent.

Diagnosis Chapter Discussion

John then transitioned the meeting to Allen L. Richards, PhD, Director, Rickettsial Diseases Research Program, Naval Medical Research Center, U.S. Department of Defense, who presented the following Diagnosis chapter recommendations, which had already been voted on and approved at Meeting 5.

• Approved Recommendation: Need to evaluate new technology or approaches for the diagnosis of Lyme disease and other tick-borne diseases.
• Approved Recommendation: Need to include special populations, especially children, in Lyme disease and other tick-borne diseases diagnostic studies.
• Approved Recommendation: Allocate resources to improve the education, diagnostics.

Allen noted that the Diagnosis chapter does not contain any new recommendations but does include a minority opinion, which Pat then presented. Pat identified the title of the minority opinion as “Patient Access to Full Lyme Disease Western Blot Results” and stated that it represents the views of those who had voted for the patient access to full Lyme disease Western blot band results, which did not pass at Meeting 5.

Allen then presented the following patient story for inclusion in the Diagnosis chapter.

• David Roth is a compelling person and highly successful business man. He had abrupt onset illness with initially negative Lyme serology, which seroconverted later into prolonged illness.

Allen described David’s story as an anecdote that represents a data-driven, evidence-based common problem; therefore, the story conveys some of the more overarching ideas highlighted in the report, for example, the common problem of the lack of sensitivity in early serologic testing.

The working group conducted a vote to include David Roth’s story in the Diagnosis chapter of the report.

Voting Results: All members present (10) voted yes. Four members were absent.

Treatment Chapter Discussion

John turned the meeting over to Wendy Adams, MBA, Research Grant Director, Bay Area Lyme (BAL) Foundation, who presented the following recommendations, which had already been voted on and approved at Meeting 5.

• Approved Recommendation: Promote research on animal models of B. burgdorferi infection and the mechanisms of disease processes in humans with an emphasis on pathologies that are currently lacking, e.g., neuroborreliosis.
• Approved Recommendation: Continued research into the pathogenesis (that is, immune response, cross-reactivity, autoimmunity, bacterial persistence, co-infections and other mechanisms) of persistent symptoms in patients who have received standard treatment regimens for tick-borne diseases including Lyme disease.
• Approved Recommendation: Conduct additional clinical trials appropriate to the target populations where gaps may exist.
• Approved Recommendation: Improve the education and research on the pathogenesis of alpha-gal meat allergy.
• Approved Recommendation: Transmission via the blood supply and pregnancy, and treatment of other tick-borne diseases and co-infections.

Wendy then presented the following new proposed recommendations, which were created in response to address gaps in the federal inventory results.

• New Recommendation: DoD:  Commence study of TBD incidence and prevalence of U.S. active and retired military and military families.  Compile data on impact of TBD on military readiness.  Create education and preparedness programs specifically geared to unique risks faced by military in training and deployment.
• New Recommendation: NIH: Create NIH TBD strategic plan, with public input during creation and implementation, to address tick-borne diseases including all stages of Lyme disease and coordinate research funding across NIAID, NINDS, NIAMS and NIMH to increase knowledge of pathogenesis, improve diagnosis and develop and test new therapeutics for tick borne diseases.  Update every 5 years.
• New Recommendation: CDC: Create specific Babesia section within CDC and dedicate funding to study babesiosis incidence and prevalence, including maternal-fetal and transplantation/transfusion transmission risk. Consider using advanced data tools such as patient registries to study potential role of Babesia in tick borne disease patients with continuing manifestations of disease after initial treatment.

In response to the first new recommendation, two working group members remarked that active members of the military and veterans fall under two different health care systems and thus should be distinguished by two separate recommendations: one directed to the DoD to cover active duty military members and one directed to the VA to cover veterans. Another member noted that “military families” should be removed from the recommendation because of feasibility issues.

The working group then voted on the following revised new recommendation.

• Revised New Recommendation: DoD: Commence study of TBD incidence and prevalence of U.S. active duty and their dependents. Compile data on impact of TBD on military readiness. Create education and preparedness programs specifically geared to unique risks faced by military in training and deployment and their families.

Voting Results: All members present (11) voted yes. Three members were absent.

Next, the working group voted on the following revised new recommendation.

• Revised New Recommendation: VA: Commence study of TBD incidence and prevalence of veterans and eligible family members.

Voting Results: All members present (11) voted yes. Three members were absent.

Wendy asked the group to consider the second new recommendation, which calls for the NIH to create a strategic plan to address tick-borne diseases (see complete wording above). Members asked for clarification about which stakeholders would provide input, whether or not the recommendation calls for new funding, and which institutes would ideally be involved. They also discussed how the peer review grant process affects funding levels. Ultimately, the group decided to leave the wording of the recommendation as is so as not to limit its interpretation.

The working group then voted on the following new recommendation.

• New Recommendation: NIH: Create NIH TBD strategic plan, with public input during creation and implementation, to address tick-borne diseases including all stages of Lyme disease and coordinate research funding across the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the National Institute of Mental Health (NIMH) to increase knowledge of pathogenesis, improve diagnosis and develop and test new therapeutics for tick borne diseases. Update every 5 years.

Voting Results: All members present (11) voted yes. Three members were absent.

Wendy asked the group to consider the third new recommendation calling for the CDC to create a specific Babesia section and dedicate funding to babesiosis (see complete wording above). One member requested clarification about what prompted the need for this recommendation to which Wendy responded that, after B. burgdorferi, babesiosis is a major obstacle to patient recovery; yet, it receives little funding and dedicated effort. Therefore, she stated, the purpose of the recommendation is to draw attention to the infection.

Another member pointed out that creating a formal organizational unit devoted to Babesia would incur additional cost and may take away from the already limited funding. Thus, the group decided to remove the language about creating a new unit. Other members asked for the addition of specific language about prevention, maternal-fetal and transplantation/transfusion risk, as well as treatment, treatment resistance, and prevalence.

The working group revised the language and voted on the following recommendation.

• Revised New Recommendation: Create specific Babesia section within CDC and dedicate funding within CDC with performance indicators to study babesiosis incidence, prevalence, treatment resistance, and prevention including maternal-fetal and transplantation/transfusion transmission risk.  Consider using advanced data tools such as patient registries to study potential role of Babesia in tick borne disease patients with continuing manifestations of disease after initial treatment.

Voting Results: All members present (12) voted yes. Two members were absent.

Following the vote, Robert (Rob) Smith, MD, MPH, FACP, FIDSA, Director and Co-Founder, Vector-Borne Disease Laboratory; Director, Division of Infectious Diseases, Maine Medical Center, stated that he would be writing a minority opinion for inclusion in the Treatment chapter.

After a short break, John asked Wendy to present the patient story for the Treatment chapter. In response, Wendy read Colonel Nicole Malachowski’s story as follows.

• Retired Colonel Nicole Malachowski, USAF, had an expanding erythema migrans (EM) rash on her hip after training in North Carolina. Doctors suspected it was a spider bite and did not mention tick-borne disease. She was given 10 days of antibiotics and a cream. Over the next month, Nicole developed malaise, paresthesias, and then a few months later neurological symptoms that manifested when she was piloting an F-15 over the Atlantic Ocean. A year later, she received another tick bite during training in Rhode Island and was told to wait to see if a rash developed. Her doctor did not mention the possibility of co-infections. Nicole tested CDC positive for B. burgdorferi and was treated for 28 days with doxycycline, which did not resolve the symptoms.  The Spaulding Rehabilitation Network diagnosed her with anaplasmosis, babesiosis, and spotted fever rickettsiosis infection. She saw two dozen doctors across eight specialties, including doctors at the VA and at top-tier academic institutions; yet no one knew what was wrong.  She was misdiagnosed with chronic fatigue syndrome and fibromyalgia and ultimately had to medically retire from the Air Force and can never fly again in the military or for commercial airlines.

Wendy provided context for why the story was chosen for inclusion in the report. Reasons included disease contraction in a state adjacent to an endemic state; rash misdiagnosis and resulting insufficient treatment; and late stage neurologic symptoms missed by many specialists. She also noted that Nicole represents a high-risk population as a member of the military.

Voting Results: All members present (10) voted yes. Four members were absent.

Access to Care, Patient Outcomes Chapter Discussion

John transitioned the meeting to Commander Scott Cooper (Coop), PA, MMS, Senior Technical Advisor and Lead Officer for Medicare Hospital Health and Safety Regulations, Centers for Medicare and Medicaid Services, U.S. Department of Health and Human Services, and Bob. They then presented the following recommendations, which had been voted on and approved at Meeting 5.

• Approved Recommendation: Create a federal repository for information on Lyme disease and other tick-borne diseases.
• Approved Recommendation: Allocate increased funding for tick-borne disease in the area of research, treatment, and prevention proportional to burden of illness and need.
• Approved Recommendation: Protection from job discrimination due to Lyme disease and other tick-borne diseases.
• Approved Recommendation: Protection for students of all ages from discrimination due to Lyme disease and other tick-borne diseases.
• Approved Recommendation: Testing and diagnostic bands—how they are used today and what that is doing to patients.

Coop then clarified that his writing group would like to revise the third and fourth recommendations to read as follow.

• New Proposed Recommendation: Ensure the rights of all patients dealing with Lyme disease and tick-borne diseases by reducing the burden of the processes under which patients are currently diagnosed and treated and by which they access care. Basic protections must include, but not necessarily be limited to, those that:
  • (3a) Protect patients from employment discrimination.
  • (3b) Protect students of all ages from discrimination.
  • (3c) Protect patients from medical and disability insurance coverage and reimbursement policies that are unduly burdensome.
  • (3d) Protect the rights of licensed and qualified clinicians to use individual clinical judgment to diagnose and treat patients in accordance with the needs and goals of each individual patient.

In discussion of the recommendation, the working group agreed to remove the phrase “all patients” in order to include caregivers and practitioners treating tick-borne disease patients. Regarding part 3a, one member asked whether or not the Americans with Disabilities Act (ADA) covers tick-borne disease patients to which Coop replied that, yes; however, the protections are not always enforced, and it is up to patients to find attorneys and specialists to represent them. Kristen then clarified that the purpose of part 3a is to call attention to the fact that Lyme disease and tick-borne diseases have the potential to disable people and to recognize that many of those people need employment protection.

In part 3c, members agreed to change “medical” to “health care.” And in part 3d, they agreed to add the phrase “as well as recognized guidelines” to complement individual clinical judgement.

Members then voted on all four parts of the recommendation as follows.

• New Revised Recommendation: Ensure the rights of those dealing with Lyme disease and tick-borne diseases by reducing the burden of the processes under which patients are currently diagnosed and treated and by which they access care. Basic protections must include, but not necessarily be limited to, those that:
  • (3a) Protect patients from employment discrimination.

Voting Results: All members present (11) voted yes. Three members were absent.

The working group then voted on part 3b of the recommendation.

• New Recommendation: Ensure the rights of those dealing with Lyme disease and tick-borne diseases by reducing the burden of the processes under which patients are currently diagnosed and treated and by which they access care. Basic protections must include, but not necessarily be limited to, those that:
  • (3b) Protect students of all ages from discrimination.

Voting Results: All members present (11) voted yes. Three members were absent.

Next, the working group voted on part 3c as follows.

• New Revised Recommendation: Ensure the rights of those dealing with Lyme disease and tick-borne diseases by reducing the burden of the processes under which patients are currently diagnosed and treated and by which they access care. Basic protections must include, but not necessarily be limited to, those that:
  • (3c) Protect patients from healthcare and disability insurance coverage and reimbursement policies that are unduly burdensome.

Voting Results: All members present (11) voted yes. Three members were absent.

The working group then voted on part 3d of the recommendation.

• New Revised Recommendation: Ensure the rights of those dealing with Lyme disease and tick-borne diseases by reducing the burden of the processes under which patients are currently diagnosed and treated and by which they access care. Basic protections must include, but not necessarily be limited to, those that:
  • (3d) Protect the rights of licensed and qualified clinicians to use individual clinical judgment, as well as recognized guidelines, to diagnose and treat patients in accordance with the needs and goals of each individual patient.

Voting Results: Eight members voted yes; three members abstained; and three members were absent.

Next, Coop stated that there were no minority responses to the Access to Care/Patient Outcomes chapter. He then asked the working group to consider the following patient story, which represents the high-risk pediatric population.

• Julia Bruzzese, who testified at Meeting 5, was told not to worry after presenting to a New York City pediatrician with a bullseye rash, which was documented in her medical records. Six years later she developed severe systemic symptoms and could no longer walk. She was told that she had a negative ELISA test, and therefore, she did not have Lyme disease. She had multiple coinfections, none of which were diagnosed by doctors. She was accused of faking her illness.

Coop provided the following reasons for including Julia’s story in the report.

• Doctors did not understand that Julia should be treated for Lyme disease, highlighting the need for improved medical education.
• Diagnostics for early, acute disease were not available.
• Julia was unable to attend school for extensive periods of time and was dismissed by the medical establishment who did not recognize her symptoms, highlighting the need for improved access to care.
• Julia’s doctors were unaware of the many possible coinfections, and as a result, they remained undiagnosed.

The working group members did not have anything to add to Julia’s story. However, one member stressed that there should be a story or sidebar that focuses on physicians who are penalized by state medical boards and the consequences this has on patient access to care. The group agreed to include this information in a sidebar. They then voted on Julia’s story as presented above.

Voting Results:  All members present (11) voted yes. Three members were absent.

Discussion of Images and Infographics to Be Included in the Working Group Report to Congress

John and Kristen presented the following list of proposed images and infographics for the working group report to Congress and the HHS Secretary, stating that they were up for consideration and discussion but not for vote. Members viewed the images in the draft report outline.

Background

• Figure 1. Number of Cases of Lyme Disease in the U.S. Over Time
• Figure 2. Cases of Post-Treatment Lyme Disease Syndrome (PTLDS) Over Time
• Figure 3. Funding for Lyme Disease vs. Other Illnesses

Epi and Ecology

• Figure 4. Disease Cases by State, 2004-2016
• Figure 5. Distribution of Ixodes scapularis & I. pacificus
• Figure 6. Tick Life Cycle

Prevention

• Figure 7. Applying DEET
• Figure 8. Walk in the Woods
• Figure 9. Landscaping Prevention
• Table 1.  Vaccine Table

Diagnosis

• Figure 10. Erythema Migrans (EM) rash

Treatment

• Figure 11. Rocky Mountain Spotted Fever, Babesia, Anaplasma
• Figure 12. B. burgdorferi Organisms

Access to Care

• Figure 13. Health Claim Form
• Figure 14. Provider and Patient Talking

The working group began by discussing the Background images. Two members expressed concern that Figure 1 only represents reported cases of Lyme disease and not the actual case load. They also stressed the importance of including information about the prevalence of all tick-borne diseases, not only in endemic regions, but also in southern and western states. John and Kristen stated that, following Meeting 6, they would present the working group with additional options for review. For Figure 2, the working group struggled with how to present statistics about PTLDS and chronic Lyme disease, especially when there is so little data available on chronic Lyme disease. Therefore, they decided not to include the image unless the group came to an agreement at a later time. Finally, the members agreed on the inclusion of Figure 3.

Next, the working group discussed the images proposed for the Epidemiology and Ecology chapter. Stating that Figure 4 was redundant, one member proposed replacing it with an infographic that highlights the recommendation that Lyme disease surveillance criteria should not be used alone for diagnostic purposes. Another member suggested adding to Figure 5 the distribution of Amblyomma americanum, or Lone Star, ticks to which John replied that a graphic containing this information could be obtained from the CDC’s website.

In response to the proposed images for the Prevention chapter, working group members agreed that there should not be photos of people hiking in shorts (Figure 7) but rather long pants, which are more effective in preventing tick bites. They also agreed to replace Figure 8 with a more appealing image. And they suggested replacing Figure 9 with an image of a back yard with captioning about landscaping to prevent ticks. One member also proposed replacing it with a photo of a mouse or deer with a caption describing vector intervention.

Members agreed that the image of the EM rash (Figure 10) in the Diagnosis chapter was effective. However, given the confusion around the presentation of rashes, they concluded that additional images of other possible rash manifestations for both Lyme disease and other tick-borne diseases were also warranted.

Working group members were pleased with Figures 11 and 12 in the Treatment chapter and suggested also including images of Borrelia miyamotoi and/or relapsing fever.

Finally, the group discussed Figures 13 and 14 proposed for the Access to Care/Patient Outcomes chapter. One member proposed including a dense Lyme disease patient file, which might be more effective than a blank health claim form (Figure 13). Another proposed using a person’s silhouette for the sidebar about the need to protect physicians who face legal challenges with state medical boards to show that many physicians who treat Lyme disease and other tick-borne diseases wish to remain anonymous for fear of losing their medical licenses.

Discussion of Topics for Technical Issue Briefs

John transitioned the meeting to James (Jim) Berger, MS, MT (ASCP), SBB, Designated Federal Officer, Tick-Borne Disease Working Group, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, who reported that the technical issue briefs that focus on the work that need to be completed to finalize the report will be discussed at Meeting 7.

Review of Meeting 6, Next Steps

Jim then presented the following timeline.

Report Process	Due Dates
Incorporate new approved recommendations into the working group report	June 22, 2018
Finalize content and writing of report based on the final list of recommendations	June 25 – July 8, 2018
Tick-Borne Disease Working Group member review of final documents (minor adjustments made)	July 9 – 13, 2018
Final report “locked down” due	July 16, 2018
Final report copyedit and 508 compliance occurs	July 17 – 23, 2018
Final virtual Meeting 7 to vote on final working group report chapter by chapter	July 24, 2018
Final report released to HHS agencies, DoD, and VA for comment	July 30, 2018
HHS agencies, DoD, and VA review due	August 30, 2018
Document revision due	September 30, 2018
Final HHS agencies, DoD, and VA clearance complete	November 1, 1018
Revision and final desktop publishing complete	November 14, 2018
Final review for typographical errors and 508 compliance complete	November 21, 2018
Submit final report to Congress	December 18, 2018
Final report posted on the Tick-Borne Disease Working Group webpage for public comment	December 18, 2018

Closing Remarks and Adjournment

Jim concluded by stating that the working group’s timeline was aggressive to which John added that the group’s last major effort would occur between Meetings 6 and 7. John then thanked everyone for their exceptional work.

Appendix: TBDWG Members and HHS Staff

TBDWG Members

Chair
John Aucott, MD, Associate Professor, Division of Rheumatology, Johns Hopkins University School of Medicine; Director, Johns Hopkins Lyme Disease Clinical Research Center

Vice-Chair
Kristen Honey, PhD, PMP, Innovator in Residence, Office of the Chief Technology Officer, Immediate Office of the Secretary, U.S. Department of Health and Human Services; Member, Stanford University Lyme Disease Working Group

Wendy Adams, MBA, Research Grant Director, Bay Area Lyme (BAL) Foundation

Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services; Associate Editor, Emerging Infectious Diseases. - Susanna N. Visser, DrPH, MS, Associate Director for Policy, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services (stand-in for Ben Beard)

Commander Scott Cooper, PA-C, MMSc, Senior Technical Advisor and Lead Officer for Medicare Hospital Health and Safety Regulations, Centers for Medicare and Medicaid Services, U.S. Department of Health and Human Services

Dennis M. Dixon, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services

Richard Horowitz, MD, Hudson Valley Healing Arts Center; member, World Health Organization’s Ad Hoc Committee for Health Equity

Captain Estella Jones, DVM, Acting Deputy Director, Office of Counterterrorism and Emerging Threats, U.S. Food and Drug Administration, U.S. Department of Health and Human Services.

Lise E. Nigrovic, MD, MPH, Director, Population Health Sciences and Health Services Research Center of the Institutional Centers for Clinical and Translational Research, Boston Children’s Hospital; Chair, Pediatric Emergency Medicine Collaborative Research Committee, American Academy of Pediatrics

Allen L. Richards, PhD, Director, Rickettsial Diseases Research Program, Naval Medical Research Center, U.S. Department of Defense

Robert Sabatino, Founder and Executive Director, Lyme Society Inc.

Vanila M. Singh, MD, MACM, Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (absent)

Patricia Smith, President, Lyme Disease Association

Robert Smith, MD, MPH, FACP, FIDSA, Director and Co-Founder, Vector-Borne Disease Laboratory, Main Medical Center Research Institute; Director, Division of Infectious Diseases, Maine Medical Center

HHS Support Staff Present

Designated Federal Officer
James Berger, MS, MT (ASCP), SBB, Senior Blood and Tissue Policy Advisor, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

Alternate Designated Federal Officer
Kaye Hayes, MPA, Deputy Director, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

Chinedu Okeke, MD, MPH-TM, MPA, Senior Policy Advisor, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services

Debbie Seem, RN, MPH, Public Health Analyst, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services