Welcome / Recap Meeting 6 / Progress Since Meeting 6
Comments Submitted in June 2018 / Public Comments
Executive Summary, Background, Methods - Review & Vote
Epidemiology and Ecology - Review &Vote
Prevention - Review &Vote
Diagnosis - Review & Vote
Treatment - Review &Vote
Access to Care, Patient Outcomes - Review &Vote
Looking Forward - Review & Vote
Conclusion, Appendices - Review & Vote
Proposed Public Comment Subcommittee
Review of Meeting 7, Next Steps / Closing Remarks
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). The meeting started with a quorum.
John began the meeting with an announcement about his participation in the voting process. He stated that, as Chair, he would only vote in the event of a tie. He also noted that this change did not affect the outcomes of previous Working Group meetings as there had not been any instances of a tie.
Recap of Meeting 6
John provided a summary of what occurred during Meeting 6 (June 21, 2018), which included reviewing and discussing public comments, discussing Federal inventories, reviewing recommendations, and voting on new and revised recommendations. That process, he noted, resulted in the final recommendations for the report to Congress and the Secretary of Health and Human Services (HHS). He then added that the Working Group reviewed and voted on patient stories and discussed tentative images and infographics to be included in the report. Finally, John concluded, the Working Group considered a motion to create a Transparency and Innovation Subcommittee to encourage stakeholder engagement, a motion that was tabled for further discussion at Meeting 7.
Overview of Progress Since Meeting 6
John thanked everyone for their hard work and accomplishments. He then outlined the tasks completed by the Working Group and its support team since Meeting 6, which included the following:
- Copyediting recommendations
- Finalizing report content
- Setting the design for the report
- Creating and finalizing chapter transitions, the Executive Summary, the Looking Forward chapter, the Conclusion, and the Appendices
- Finalizing patient stories, images, and image captions
- Editing the entire document to create consistency across the document and minimize redundancies
Regarding the last bullet, John added that there is still some variability in the document, which is “a natural outgrowth” of having 14 authors writing a report. He also noted that the report is nearly twice as long as was originally projected, which reflects the Working Group’s focus on including important information rather than adhering to a strict page limit.
John then described the Working Group’s process for reviewing and revising the final content of the report. Each member was given access to the chapters using file sharing and collaboration software, which allowed members to make comments. The leadership team then reviewed those comments and addressed controversial topics with the writing group leads in an effort to reach a consensus. Any remaining issues, he stated, were resolved among the leadership by raising them, if possible, to a level that all members could agree on. Finally, the report was copyedited to resolve language inconsistencies, and the content was “locked down” and put in the final format being reviewed at Meeting 7. Going forward, John noted, the report would be copyedited once more and made 508 compliant.
John outlined the agenda for Meeting 7, which included
- discussing public comments submitted in June 2018,
- hearing public comments,
- reviewing recommendations and voting on proposed language corrections, and
- voting on the report chapters as a whole, including images, patient stories, and minority responses.
John then transitioned the meeting to 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, who led the discussion of public comments received during the month of June 2018
Discussion of Public Comments Submitted in June 2018
Kristen began by reminding meeting participants about the three ways the public can submit comments to the Working Group. These include:
- Making verbal comments at Working Group meetings.
- Submitting written comment for specific meetings. These comments are available on the Working Group’s website on the individual meeting pages found here: https://www.hhs.gov/ash/advisory-committees/tickbornedisease/meetings/index.html.
- Emailing comments at any time to [email protected].
Kristen then summarized the key themes the Working Group identified from the public comments received during the month of June 2018. They are as follows.
- The Working Group should focus on all tick-borne diseases, illnesses, and conditions, including alpha-gal, and should consider mentioning “tick-borne conditions” in addition to “tick-borne diseases” to be more inclusive of all manifestations.
- Rapid detection methods are critically needed. Requests to know the status of the Lyme test study - a National Institute of Standards and Technology and Johns Hopkins School of Medicine collaboration.
- Lyme is a huge threat and should be at a high-risk level and same federal funding priority level as HIV/AIDS.
- Loved ones are dying and suffering—please help now. Action is needed now.
- Insurance companies need to understand that they’re losing money by ignoring tick-borne illnesses. Treating people in a timely manner will save them money in the long term.
- Anecdotal experiences of long-term antibiotic treatment do not match up with some of the current guidelines. The Working Group and the Federal government should start anew, look at all available evidence, and move beyond dogma and division.
- Working Group transcripts and videos should be released in a timelier manner. And many requests for Working Group transparency beyond posting meeting content.
- The public is concerned about conflicts of interest on the Working Group.
- The public—including doctors and clinicians who submitted comment—are concerned about doctors losing their licenses or going bankrupt because of legal costs associated with treating these patients.
- The World Health Organization (WHO) Classification of Diseases (ICD) needs to be updated, including words being used, such as “lingering” to describe ongoing borreliosis symptoms as it minimizes the effects of the disease.
- To this Kristen noted that the Working Group asked behavioral and mental health experts to review the language in its report to ensure there was no victim blaming and that is was in a tone to help us reset and move forward.
- The public called for good quality science: “Help health care professionals help patients.”
At this point, John introduced the public comment portion of the meeting.
Public Comments
Six members of the public provided comments to the Working Group.
Jill Auerbach: Jill stressed the need for tick population control as well as vaccines and other methods for blocking ticks’ ability to transmit pathogens. She stated that the Working Group’s recommendations focused heavily on developing human vaccines and not enough on conducting tick research and developing novel genetic approaches to killing ticks without harming other animals. Jill also highlighted the effectiveness of spraying as a tick control measure, but only when best practices are used. As such, she stated that the following subcommittee recommendation should be included in the report: “Develop best practices, tick control training materials, online or video, for pest control operators with continuing education compliance a requirement for continuing licensure.” She encouraged the Working Group members to vote no on the Prevention chapter and “revise it to increase the importance of tick and environmental research.”
Bethany Opiela: Bethany described herself as 13-year-old girl who has had alpha-gal syndrome for the past seven years. She noted that, during the first year of her illness, she was seen by 28 doctors, including emergency room (ER) doctors and specialists in cardiology, neurology, and gastroenterology. Despite multiple ER visits and hospitalizations, she stated that she felt fortunate not to have had her appendix or gall bladder removed like some of the other children with alpha-gal syndrome whom she had spoken to. She added that, if it were not for her father and his extensive researching, she would not have been given an accurate diagnosis, which “is only half the battle.”
Bethany explained that alpha-gal syndrome has changed her life dramatically—physically, socially, and academically. She and others with alpha-gal syndrome cannot be exposed to many vaccinations and school supplies containing mammalian products; may not be able to use the school cafeteria; and may have to make special arrangements in order to attend birthday parties. These experiences, she stated, made her feel “different and isolated,” and caused her to lose friends. She encouraged the Working Group to
- Encourage the Food and Drug Administration (FDA) to improve food labeling;
- Recommend increased funding for alpha-gal syndrome research; and
- Recommend improved training of physicians, emergency room doctors, and dentists to diagnose and treat alpha-gal syndrome patients and prevent accidental death.
Beth Carrison-van der Heide: Beth stated that she was diagnosed with alpha-gal syndrome and Lyme disease. Speaking on behalf of the alpha-gal syndrome community and Tick-Borne Conditions United, she expressed concern about the Working Group’s use of the term “red-meat allergy” to refer to alpha-gal syndrome because it is misleading and confusing. She, therefore, urged the Working Group to update the language in their report and also replace the phrase “tick-borne diseases” with “tick-borne conditions” to be inclusive of alpha-gal syndrome and other conditions that have not yet been identified as a disease or illness.
Beth also stressed the urgent need for improvement in the areas of diagnosis, testing, and treatment of alpha-gal syndrome. Specifically, she highlighted the importance of
- Developing a new model of testing for alpha-gal syndrome;
- Educating the public and clinicians to take immediate action after a known bite by a lone star or longhorned tick;
- Including alpha-gal syndrome in the studies on maternal/fetal; and transplantation/transfusion transmission risk because, she added, pregnant mothers risk loss of pregnancy, and babies born from mothers with alpha-gal syndrome may develop mast cell activation syndrome.
Deborah Olsen: Deborah explained that she is 57 years old; that she has had alpha-gal syndrome for 11 years; and that she was undiagnosed for six years, three of which she spent “trying to convince doctors something was wrong.” In order to receive an accurate diagnosis, she described having to go to great lengths to convince both her doctor and the laboratory to do a full alpha-gal panel, which came back positive. She added that she was the second person in the state of Delaware to be diagnosed with alpha-gal syndrome, despite that the lone star tick “has not been formally documented” in the state. Deborah noted that, in addition to several bouts of anaphylaxis, she now has chronic urticaria resulting from fly bites that activated her alpha-gal syndrome at the beginning of the only vacation she has ever been able to take.
Deborah highlighted that by the time those with alpha-gal syndrome are diagnosed, most have not been treated with antibiotics. Moreover, she added, alpha-gal syndrome is treated like an allergy rather than an illness. She referenced a poll involving 7,000 alpha-gal patients, most of whom “were never treated with antibiotics and continued to suffer with Lyme disease-like symptoms.” Many, she noted, were also given western blot tests, which often came back negative for Lyme disease. Deborah urged the Working Group to “consider alpha-gal syndrome a full-blown tick-borne disease” and “establish a national protocol for all tick bites” and/or “initiate a study to see if [those with alpha-gal syndrome] have a tick-borne disease that has not yet been named or discovered.”
Jennifer Platt: Jennifer, from North Caroline, noted that she has three tick-borne conditions, has a PhD in public health, and is a cofounder of Tick-Borne Conditions United. She urged the Working Group to read the written public comments written by those with alpha-gal syndrome, all of whom “[present] with unique symptoms.” She also expressed the following concerns relating to the Working Group’s report and processes:
- Incorporate data presented in the recent Klaus study of ticks and the diseases they carry.
- Include information in the Prevention chapter about 2-Undecanone, which Jennifer stated, has been “recommended by the Centers for Disease Control and Prevention (CDC)” and “has been shown to be effective against ticks in multiple peer-reviewed journals.”
- Reconsider the use of Figure 8 (Create a Tick-Safe Zone Through Landscaping) because it only addresses the black-legged tick; whereas the lone star tick behaves differently by actively seeking out prey from a distance.
- Address the inconsistent use of the terms “diseases,” “infections,” and “conditions” and be sure to include “conditions” throughout.
- Explain how public comment from Meeting 7 will be included in the report.
Phyllis Mervine: Phyllis described herself as the president and founder of Lymedisease.org and noted that she participated in the Working Group’s subcommittee on Disease Vectors, Surveillance, and Prevention. She highlighted the need for enhanced transparency, peer review, and accountability in CDC processes, stating that some information disseminated by CDC has not been peer-reviewed; that conflicts of interest have not been analyzed; and that there are no public hearings or methods for patients to voice their concerns. She also noted that “patients are being denied access to essential medical care because of [CDC-disseminated information that] has not been subjected to peer review.”
Phyllis urged the Working Group to “ask Congress to instruct the CDC to comply with the ‘Final Information Quality Bulletin for Peer Review,’ published by the Office of Management and Budget in 2004 regarding influential scientific information.” In doing so, she added, CDC should “review and revamp the Lyme disease part of its website” by having the information peer-reviewed (regardless of when it was posted) by various stakeholders, including patients. She also stated that reviewers with conflicts of interest should be excluded from the process. These steps, she noted, could help improve public trust in information disseminated by the government.
Executive Summary—Review and Vote
John explained to the Working Group members that in reviewing their final report to Congress and the HHS Secretary, they would start at the beginning of the document and work their way through each section. If applicable, they would review recommendations first and vote on any that contained newly copyedited language. They would then review and vote on the chapters as a whole, including the images, patient stories, and minority responses.
In the Executive Summary, the Working Group reviewed the content as well as Figure 1: Federal Funding for Selected Infectious Diseases. One of the members asked for clarification on some of the information in the figure, which the other members provided.
The Working Group then conducted a vote to accept the Executive Summary, including Figure 1, in its report.
Voting Results: Of the 13 members present, 12 voted yes and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
Background—Review and Vote
Kristen presented the Background section, which included the following features:
- Figure 2: Tick-Borne Diseases in the United States
- Figure 3: Annual Number of New Lyme Disease Cases
- Patient Story: Ruben Lee Sims
One of the members expressed concern about Figure 2, stating that the images give the impression that Lyme disease is only present in the Northeast and Upper Midwest; The member also suggested removing the following content from the Figure 3 cation: “Using a research definition of and data on post-treatment Lyme disease syndrome (PTLDS), the number of PTLDS cases may approach 30,000-60,000 each year in the United States. A precise definition does not yet exist for chronic Lyme disease, so uncertainty is extremely large. The number of U.S. patients with a clinical diagnosis of chronic disease may be larger, but is unknown”; she was concerned that the language may “open the door to using the term post-treatment Lyme disease syndrome.” After some discussion, the group decided to add a legend or label to better explain Figure 2 and keep the Figure 3 caption as is, although the one member continued to disagree with the caption’s inclusion.
The Working Group then voted to accept the Background section, including Figures 2 and 3 with the abovementioned copyedits, as well as the Ruben Lee Sims’s Patient Story.
Voting Results: Of the 13 members present, 12 voted yes and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
Methods—Review and Vote
John presented the Methods section, which included information on the Working Group’s use of subcommittees, Federal inventory, and public input to gather information for its report. It also described how minority responses were presented in the document.
The Working Group members did not have additional comments and immediately conducted a vote to include the Methods section in their report.
Voting Results: Of the 13 members present, 12 voted yes and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
Epidemiology and Ecology—Review and Vote
Kristen began the review of the Epidemiology and Ecology chapter by presenting two recommendations that had been copyedited since Meeting 6. Neither prompted discussion, and both are presented below along with the voting results. The other three recommendations for this chapter remained unchanged from Meeting 6.
- Original Recommendation 2.1: 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.
- Copyedited Recommendation 2.1: 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.
Voting Results: Of the 13 members present, 12 voted yes and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
- Original Recommendation 2.5: 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).
- Copyedited Recommendation 2.5: 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 message to 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).
Voting Results: Of the 12 members present, 11 voted yes and zero voted no; two members were absent. Chair John Aucott did not vote. The motion passed.
Kristen then presented the contents of the chapter, including the following features:
- Figure 4: 1996—Distributions of Two Tick Species; 2015—Distributions of Two Tick Species
- Figure 5: Ixodes Tick Life Cycle and the Transmission of Lyme Disease (Borrelia burgdorferi)
- Patient Story: Dr. Neil Spector
In discussion, one member pointed out a correction to the content and also inquired about the accuracy of the following statement: “Lyme carditis occurs in approximately 1% of cases based on Lyme disease surveillance criteria reported to CDC, yet more research is needed.” The group agreed to confirm the CDC data and include it in the report.
The Working Group then conducted a vote to accept the Epidemiology and Ecology chapter, including the most up-to-date CDC surveillance information on Lyme carditis, Figures 4 and 5, and Dr. Neil Spector’s Patient Story.
Voting Results: Of the 11 members present at the time, 10 voted yes and zero voted no; three members were absent. Chair John Aucott did not vote. The motion passed.
Prevention—Review and Vote
Kristen began the review of the Prevention chapter by presenting all four recommendations, which had been copyedited since Meeting 6. The recommendations and voting results are presented below.
- Original Recommendation 3.1: 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.
- Copyedited Recommendation 3.1: 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.
Voting Results: Of the 12 members present at the time, 10 voted yes and one voted no; two members were absent at time. Chair John Aucott did not vote. The motion passed.
- Original Recommendation 3.2: 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.
- Copyedited Recommendation 3.2: Build trust via a transparent mechanism by which all stakeholders examine and discuss past vaccine activities and potential adverse events to inform future vaccine development in Lyme disease.
Voting Results: Of the 12 members present at the time, 10 voted yes and one voted no; two members were absent. Chair John Aucott did not vote. The motion passed.
- Original Recommendation 3.3: 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.
- Copyedited Recommendation 3.3: Support the development of safe and effective human vaccines to prevent Lyme disease with transparent mechanisms by which all stakeholders examine and discuss past vaccine activities and potential adverse events to inform future vaccine development.
Voting Results: Of the 12 members present at the time, 10 voted yes and one voted no; two members were absent. Chair John Aucott did not vote. The motion passed.
- Original Recommendation 3.4: Education - Inform clinicians and general public of regional and specific risks related to tick illnesses.
- Copyedited Recommendation 3.4: Prioritize education by informing clinicians and the public about the regional and specific risks related to tick-borne disease and conditions.
Voting Results: Of the 12 members present at the time, 10 voted yes and one voted no; two members were absent. Chair John Aucott did not vote. The motion passed.
Next, John presented the Prevention chapter content, including the following features:
- Figure 7: Treat Your Clothing with Permethrin
- Figure 8: Create a Tick-Safe Zone Through Landscaping
- Table 1: How Vaccines Can Potentially Prevent Lyme Disease
- Minority Response
When discussing the Prevention chapter, one Working Group member questioned the accuracy of the following statement: “Most pathogens that are transmitted by the Ixodes species of tick usually require more than 24 hours of feeding to infect a host.” The member noted that there is peer-reviewed literature that suggests transmission time may occur in less than 24 hours depending on the situation. Another member questioned the omission of Borrelia miyamotoi from Table 1, noting that there are many areas in California where B. miyamotoi is more prevalent than B. burgdorferi. However, given that the table is about Lyme disease, and B. miyamotoi is very different than Lyme disease, the group decided to leave the table as was presented.
The Working Group then voted on accepting the Prevention chapter, including Figures 7 and 8, Table 1, and the Minority Response.
Voting Results: Of the 12 members present, 11 voted yes and zero voted no; two members were absent. Chair John Aucott did not vote. The motion passed.
Diagnosis—Review and Vote
Kristen first presented the two recommendations in the Diagnosis chapter, both of which had been copyedited since Meeting 6. Neither prompted discussion, and both are presented below along with the voting results.
- Original Recommendation 4.1: Need TO EVALUATE NEW TECHNOLOGY OR APPROACHES FOR THE DIAGNOSIS OF LYME DISEASE AND OTHER TICK-BORNE DISEASES.
- Copyedited Recommendation 4.1: Evaluate new technology or approaches for the diagnosis of Lyme disease and other tick-borne diseases.
Voting Results: Of the 10 members present at the time, nine voted yes and zero voted no; four members were absent. Chair John Aucott did not vote. The motion passed.
- Original Recommendation 4.2: NEED TO INCLUDE Special populations, ESPECIALLY CHILDREN, IN LYME DISEASE AND OTHER TICK-BORNE DISEASES DIAGNOSTIC STUDIES.
- Copyedited Recommendation 4.2: Include special populations, especially children, in Lyme disease and other tick-borne diseases diagnostic studies.
Voting Results: Of the 10 members present at the time, nine voted yes and zero voted no; four members were absent. Chair John Aucott did not vote. The motion passed.
Kristen then presented the Diagnosis chapter contents, including the following features:
- Figure 9: Skin Rashes of Lyme Disease
- Figure 10: Skin Rashes of Tick-Borne Diseases
- Figure 11: Immune Response to Rickettsial Infection
- Minority Response
- Patient Story: David Roth
In discussion of the Diagnosis chapter, one Working Group member expressed concern that the report does not mention that laboratory tests can yield a negative result after the first few weeks of infection, especially when people form antibody complexes. The member noted that the Working Group is, therefore, “missing that whole segment of people who have antibodies, but who do not get picked up by current tests.” Another member agreed and added that there are data showing that some individuals with Lyme borreliosis have antibody negative test results, “even at late stages when they should be positive”; and also that the report does not include statistics about the insensitivity of early testing. A third member expressed similar apprehensions.
The Working Group made note of these concerns and voted to accept the Diagnosis chapter, including Figures 9, 10, and 11, the Minority Response, and David Roth’s patient story.
Voting Results: Of the 13 members present, 12 voted yes and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
Treatment—Review and Vote
Kristen presented four of the five Treatment chapter recommendations, which had been copyedited since Meeting 6. The fifth recommendation (5.4) remained unchanged. The recommendations, relevant discussions, and voting results are presented below.
- Original Recommendation 5.1: 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.
- Copyedited Recommendation 5.1: Prioritize research into the potential pathogenic mechanisms (such as, 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.
Voting Results: Of the 13 members present, 12 voted yes and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
- Original Recommendation 5.2: 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.
- Copyedited Recommendation 5.2: Promote research on animal models of Borrelia burgdorferi infection (that is, Lyme disease) and the mechanisms of disease processes in humans with an emphasis on pathologies that are currently lacking, for example, neuroborreliosis.
Voting Results: Of the 13 members present, 12 voted yes and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
- Original Recommendation 5.3: (INCLUDING TRANSMISSION VIA THE BLOOD SUPPLY AND PREGNANCY), AND TREATMENT OF OTHER TICK-BORNE DISEASES AND CO-INFECTIONS.
- Copyedited Recommendation 5.3: Improve the education and research on transmission (including transmission via the blood supply and pregnancy) and treatment of other tick-borne diseases and co-infections.
Voting Results: Of the 13 members present, 12 voted yes and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
- Original Recommendation 5.5: IMPROVE THE EDUCATION AND RESEARCH ON THE PATHOGENESIS OF ALPHAGAL MEAT ALLERGY.
- Copyedited Recommendation 5.5: Improve the education and research on the pathogenesis of alpha-gal allergy, also known as the tick-caused “meat allergy.”
Before voting on the copyedited version of Recommendation 5.5, the Working Group discussed whether to use the term “alpha-gal syndrome” or “alpha-gal allergy.” Given the intended audience for the report, the members decided that “alpha-gal allergy” was most appropriate.
Voting Results: Of the 13 members present, 12 voted yes and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
Next, John presented the Treatment chapter, including the following features:
- Figure 12: Types of Organisms That Cause Tick-Borne Disease
- Figure 13: Borrelia burgdorferi Causes Lyme Disease
- Minority Response
- Patient Story: Nicole Malachowski
During the discussion about the chapter content, one Working Group member expressed concern that the term “chronic Lyme disease” was not presented alongside the term “post-treatment Lyme disease syndrome” or “PTLDS,” specifically in the second paragraph of page 52 in the report PDF, but also in other instances throughout the document. Two other members explained the rationale for the presentation of those terms, but also agreed that there were some inconsistencies in their use, given that there were 14 authors involved in writing the report.
The Working Group then voted to accept the Treatment chapter with the addition of the term “chronic Lyme disease” in the second paragraph on page 52 of the report, and including Figures 12 and 13, the Minority Response, and Nicole Malachowski’s Patient Story.
Voting Results: Of the 13 members present, 12 voted yes and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
Access to Care, Patient Outcomes—Review and Vote
Kristen presented all three Access to Care, Patient Outcomes chapter recommendations, which had been copyedited since Meeting 6. She also presented the copyedited version of the Major Issue that had been identified during Meeting 6. The recommendations, major issue, relevant discussions, and voting results are presented below.
- Original Recommendation 6.1: CREATE A FEDERAL REPOSITORY FOR INFORMATION ON LYME DISEASE AND OTHER TICK-BORNE DISEASES TO ENCOMPASS:
- Copyedited Recommendation 6.1: Create a federal repository for information on Lyme disease and other tick-borne diseases.
Voting Results: Of the 13 members present, 12 voted yes and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
- Original Recommendation 6.2: Allocate increased funding for tick-borne disease in the area of research, treatment, and prevention PROPORTIONAL TO BURDEN OF ILLNESS AND NEED.
- Copyedited Recommendation 6.2: Allocate increased funding for tick-borne disease in the areas of research, treatment, and prevention proportional to the burden of illness and need.
Voting Results: Of the 13 members present, 12 voted yes and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
- Original Recommendation 6.3: Ensure the rights of those dealing with Lyme disease and TBDs 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:
- 6.(3a)Protect patients from employment discrimination.
- 6.(3b) Protect students of all ages from discrimination.
- 6.(3c) Protect patients from healthcare 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, as well as recognized guidelines, to diagnose and treat patients in accordance with the needs and goals of each individual patient.
- Copyedited Recommendation 6.3: Ensure the rights of those dealing with Lyme disease and tick-borne diseases and conditions 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:
- 6.(3a) Protect patients from employment discrimination.
- 6.(3b) Protect students of all ages from discrimination.
- 6.(3c) Protect patients from health care 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, as well as recognized guidelines, to diagnose and treat patients in accordance with the needs and goals of each individual patient.
Voting Results: Of the 13 members present, 12 voted yes and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
- Major Issue/Controversy—Testing and Diagnostic Bands: How They Are Used Today and What That Is Doing to Patients
- Major Issue 6.4: Testing and Diagnostic Bands: How They Are Used Today and What That Is Doing to Patients
- Empower patients with data
- Engage diverse stakeholders
- Relay information as a neutral knowledge broker
Prior to voting, one Working Group member commented that, in the Major Issue section of the report, it would be more accurate to change “CDC surveillance criteria” to the “Council of State and Territorial Epidemiologists (CSTE) surveillance criteria.” Kristen noted that this correction can be made when CDC reviews the report.
Voting Results: Of the 13 members present, 11 voted yes, one abstained, and zero voted not; one member was absent. Chair John Aucott did not vote. The motion passed.
Next, Kristen presented the Access to Care, Patient Outcomes chapter including the following features:
- Figure 14: Health Insurance Claims
- Figure 15: Extensive Medical Records
- Figure 16: Patient-Provider Relationship
- Challenges Facing Physicians and Impeding Patient Access to Care
- Patient Story: Julia Bruzzese and Family
During the chapter discussion, one Working Group member expressed concern that the chapter may give the impression that there are no formal treatment guidelines for how to safely treat patients with tick-borne diseases. Another member countered by stating that the chapter describes two different sets of guidelines.
The Working Group then voted to accept the Access to Care, Patient Outcomes chapter, including Figures 14, 15, and 16, Challenges Facing Physicians and Impeding Patient Access to Care, and Julia Bruzzese and Family’s Patient Story.
Voting Results: Of the 13 members present, 10 voted yes, two abstained, and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
Looking Forward—Review and Vote
Kristen presented four of the five Looking Forward recommendations, which had been copyedited since Meeting 6. None prompted discussion, and all four of the copyedited recommendations are presented below along with the voting results. The fifth recommendation for this chapter remained unchanged from Meeting 6.
- Original 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.
- Copyedited Recommendation: NIH: Create an NIH tick-borne disease strategic plan, with public input during creation and implementation, to address tick-borne diseases, including all stages of Lyme disease. Include in the plan the coordination of 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 five years.
Voting Results: Of the 12 members present at the time, 11 voted yes and zero voted no; two members were absent. Chair John Aucott did not vote. The motion passed.
- Original Recommendation: CDC: 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.
- Copyedited Recommendation: CDC: 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 the potential role of Babesia in tick-borne disease patients with continuing manifestations of disease after initial treatment.
Voting Results: Of the 13 members present, nine voted yes, three abstained, and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
- Original Recommendation: DoD [Department of Defense]: 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.
- Copyedited Recommendation: DoD: Commence study of tick-borne disease incidence and prevalence of U.S. active duty and their dependents. Compile data on the impact of tick-borne diseases on military readiness. Create education and preparedness programs that specifically address the unique risks faced by military in training and on deployment, and by their families.
Voting Results: Of the 13 members present, 10 voted yes, two abstained, and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
- Original Recommendation: VA [Veterans Affairs]: Commence study of TBD incidence and prevalence of veterans and eligible family members.
- Copyedited Recommendation: VA: Commence study of tick-borne disease incidence and prevalence of Veterans and eligible family members.
Voting Results: Of the 13 members present, 10 voted yes, two abstained, and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
The Working Group reviewed and briefly discussed the Looking Forward chapter, which contained the group’s Core Values and Shared Vision statement. One member suggested formatting the recommendations to look like those in the other chapters.
The Working Group then voted to accept the Looking Forward chapter, including the reformatted recommendations as well as the Core Values and Shared Vision statement.
Voting Results: Of the 13 members present, 12 voted yes and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
Conclusion—Review and Vote
After a brief break, the Working Group reviewed the Conclusion chapter, which the members voted to accept as is without discussion.
Voting Results: Of the 13 members present, 12 voted yes and zero voted no; one member was absent. Chair John Aucott did not vote. The motion passed.
Appendices—Review and Vote
John presented Appendices A through G, which had been created since Meeting 6. The appendices, relevant discussions, and voting results are presented below.
- Appendix A. Tick-Borne Disease Working Group
Members voted to accept Appendix A with a few corrections.
Voting Results: Of the 12 members present at the time, 11 voted yes and zero voted no; two members were absent. Chair John Aucott did not vote. The motion passed.
- Appendix B. List of Acronyms and Abbreviations
Members voted to accept Appendix B with the addition of the acronyms for 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).
Voting Results: Of the 12 members present, 11 voted yes and zero voted no; two members were absent. Chair John Aucott did not vote. The motion passed.
- Appendix C.
- C1. CDC-Listed Tick-Borne Diseases in the United States
- C2. Annual Reported Tick-Borne Disease Cases by Year, U.S.: 2004-2016
In discussing Appendix C1, the Working Group members expressed several concerns, including the inconsistent use of the terms “pathogen” and “disease,” the use of the vernacular term “Rocky Mountain spotted fever,” the omission of B. bissettii, as well as conditions such as alpha-gal allergy and tick paralysis. In response, they decided to add “sensu stricto” after “B. burgdorferi” and replace “B. mayonnii” with “B. burgdorferi sensu lato.” They also agreed to change the title of Appendix C1 to “U.S. Tick-Borne Diseases and Associated Agents.”
During the discussion of Appendix C2, the members questioned whether or not the graph reflects the significance of the problem of tick-borne diseases in the United States. They then decided to add clarifying statement about the 8- to 12-fold underreporting that is estimated for tick-borne diseases.
The Working Group then voted to accept Appendix C including the changes outlined in the previous two paragraphs.
Voting Results: Of the 12 members present at the time, 11 voted yes and zero voted no; two members were absent. Chair John Aucott did not vote. The motion passed.
- Appendix D. Inventory
The Working Group members noted a few copyedits to Appendix D and then voted to accept it.
Voting Results: Of the 12 members present, 11 voted yes and zero voted no; two members were absent. Chair John Aucott did not vote. The motion passed.
- Appendix E. 21st Century Cures Act
The Working Group voted to accept Appendix E with the deletion of the URL from the last paragraph.
Voting Results: Of the 11 members present at the time, 10 voted yes and zero voted no; three members were absent. Chair John Aucott did not vote. The motion passed.
- Appendix F. Working Group Charter
In Appendix F, the Working Group members agreed to a parenthetical reference to Appendix E. They then then voted to accept Appendix F.
Voting Results: Of the 11 members present, 10 voted yes and zero voted no; three members were absent. Chair John Aucott did not vote. The motion passed.
- Appendix G. References
The Working Group voted to accept Appendix G with no discussion.
Voting Results: Of the 11 members present at the time, 10 voted yes and zero voted no; three members were absent. Chair John Aucott did not vote. The motion passed.
Discussion of Proposed Public Comment Subcommittee
At this time, Kristen proposed a motion, which had been tabled at Meeting 6, to establish a Public Comment Subcommittee that will review emails received at [email protected] and synthesize public feedback to help the Working Group deliver on its mission. She provided the following language from the Working Group’s charter as rationale for forming the subcommittee:
(C) Solicit input from States, localities, and non-governmental entities, including organizations representing patients, health care providers, researchers, and industry regarding scientific advances, research questions, surveillance activities, and emerging strains in species of pathogenic organisms.
She added that there was no rigorous system for processing public comment and that, until Meeting 7, just two members had been reviewing all of the comments and identifying key themes and potential recommendations for the Working Group to consider.
Kristen proposed that the Public Comment Subcommittee perform the following tasks:
- Read all emails to the Tick-Borne Disease Working Group.
- Regularly (for example, quarterly) synthesize key themes from these emails and other input.
- Informed by these emails, make suggestions to the Working Group and HHS on how best to listen and respond to stakeholders. The Working Group could then translate the public input into potential recommendations for Working Group consideration in the 2020 report.
Kristen clarified that the proposed subcommittee would consist of a subset of voting Working Group members, and that participation would be voluntary. She, herself, would offer some administrative support as part of her new role within HHS and volunteer to be subcommittee co-chair or chair, if no one volunteered to lead.
In discussion, two members expressed concern about the function of the proposed subcommittee and whether or not its responsibilities would be expanded in the future. They stated that they had not had enough time to review the proposal.
The Working Group then voted on a motion to table the motion to form a Public Comment Subcommittee.
Voting Results: Of the 10 members present at the time, two voted yes and seven voted no; four members were absent. Chair John Aucott did not vote. The motion failed.
The Working Group then voted to form a Public Comment Subcommittee.
Voting Results: Of the 10 members present at the time, seven voted yes, one voted no, and one abstained; four members were absent. Chair John Aucott did not vote. The motion passed.
Review of Meeting 7 and Next Steps
John reviewed the following Timeline and Next Steps for the Working Group and its report to Congress and the HHS Secretary.
Timeline and Next Steps
| Report Process | Due Dates |
|---|---|
| Minor copyedits; convert from design program to Word | July 25-30, 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, 2018 |
| Revision and final desktop publishing complete | November 14, 2018 |
| Final review for typographical errors plus 508 compliance complete | November 21, 2018 |
| Submit final report to Congress | December 18, 2018 |
| Final report posted on the TBDWG webpage for public comment | December 18, 2018 |
In addition to the timeline, John outlined the expectations for the Working Group going forward. He noted that the Tick-Borne Disease Working Group does not have any budgetary authority and does not have programmatic status to implement changes. Rather, the programmatic changes will occur when Congress and the HHS Secretary make their budgetary decisions. He added that when the second phase of the Working Group begins, members will resolve any unfinished business and move forward with new analysis and new recommendations.
Kristen noted that, in terms of the Working Group’s membership, the seven Federal seats will not change in phase two, although different individuals may be assigned. However, the appointments of the non-Federal seats will end in March 2019, except for those individuals who joined the Working Group late in phase one. She added that there will be a call for new members at the beginning of 2019.
One member inquired about the nature of the edits that the Federal agencies will be calling for following their review of the Working Group’s report. James (Jim) Berger, MS, MT (ASCP), SBB, Designated Federal Officer, Tick-Borne Disease Working Group 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, responded that the Working Group should expect minimal editing and questions for clarification. Kristen added that, if the Federal agencies require more significant revisions, the Working Group may reconvene in the fall in order to review them. Otherwise, she stated that she did not expect the members to meet again until at least December 2018.
Closing Remarks and Adjournment
John concluded the meeting by thanking the Vice-chair, the Working Group, its support staff, and its subcommittee members for their significant contributions to the report.
The meeting was adjourned at 4:44 pm EDT.
Appendix: TBDWG Members and HHS Support 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 T. 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 A. 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.
Captain 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 I. 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. - David Leiby, PhD, Chief, Product Review Branch, Center for Biologicals Evaluation and Research, U.S. Food and Drug Administration, U.S. Department of Health and Human Services (stand-in for Captain Estella Jones during afternoon session)
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 (Absent)
Allen L. Richards, PhD, Director, Rickettsial Diseases Research Program, Naval Medical Research Center, U.S. Department of Defense
Robert (Bob) 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 (Rob) 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
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
