TBDWG December 11, 2017 - Meeting Summary
Meeting One Proceedings
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 be heard and valued based on merit and without the bias of titles, eminence, or prestige.
Official Welcome and Swearing In of Members
Richard Wolitski, Designated Federal Officer
Don Wright, Acting Assistant Secretary for Health
Richard (Rich) Wolitski, PhD, Director, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, introduced himself, welcomed all participants, and stated his position as the Designated Federal Officer (DFO) whose role is to support and coordinate the group’s activities and ensure compliance with the Federal Advisory Committee Act (FACA). He then introduced Don Wright, MD, MPH, Acting Assistant Secretary for Health (ASH), who took the stage.
The Acting ASH expressed his gratitude for everyone’s participation in what is “unquestionably a historic event.” He added that the U.S. Department of Health and Human Services (HHS) understands the seriousness of tick-borne diseases and the risks they pose to Americans. The agency is pleased with the range of expertise and perspectives represented within the group and is eager for work to begin. He then summarized the Tick-Borne Disease Working Group’s mission and added that HHS will support the group’s efforts and help “earn the trust of the public by making the activities of the working group both transparent and open to the general public.”
Following his introductory comments, the Acting ASH swore in the public members of the Tick-Borne Disease Working Group, thus officially convening its first public meeting. He then turned over the meeting to the working group Chair and Vice-Chair.
Welcome from the Working Group
John Aucott, Chair
Kristen Honey, Vice-Chair
After welcoming members as well as the public and web audience, John Aucott MD, Associate Professor, Division of Rheumatology, Johns Hopkins University School of Medicine; Director, Johns Hopkins Lyme Disease Clinical Research Center, announced that the working group has convened in order to begin a process that will “make life better for Americans whose lives have been affected by tick-borne disease and to prevent others from having to go through what many have suffered.” The group’s charge from Congress is to identify knowledge gaps and unresolved issues and questions raised by various stakeholders, including researchers, healthcare professionals, patients, and patient advocates. He clarified that the working group is not expected to solve these problems; rather, the working group will report their findings and recommendations to Congress and the Secretary of Health and Human Services, who will make policy, programmatic, and funding decisions.
John highlighted the need for constructive, open, and unbiased collaboration in an effort to bridge perspectives and form a collective expertise. He also stressed the importance of putting the patients’ needs at the forefront of the group’s activities and accepting that uncertainty will be a major factor throughout the process. However, based on his experiences during the early days of the HIV epidemic, he strongly believes that “knowledge can surmount uncertainty.” He then gave the floor to Vice-Chair Kristen Honey, PhD, PMP, Senior Policy Analyst, Office of Management and Budget, Executive Office of the President; Senior Research Scholar, Stanford University; Member, Stanford University Lyme Disease Working Group.
Kristen welcomed participants as well and made special mention of the live-stream attendees who could not travel to the meeting due to poor health or financial strain caused by tick-borne diseases. She stressed the importance of incorporating the patient perspective into the working group’s recommendations and encouraged patients who weren’t able to attend to share their comments through the virtual platform.
Citing a recent talk given by VADM Jerome Adams, MD, MPH, U.S Surgeon General, regarding the opioid epidemic, Kristen outlined a three-pronged approach to addressing tick-borne diseases:
- Better data: Working group members will commit to improving their understanding of the crisis by supporting timely public health data and reporting.
- Better research: The working group will synthesize and evaluate cutting edge research opportunities and gaps.
- Better collaboration: The working group will regard all perspectives as equally valuable and strive to create and maintain strong relationships among diverse stakeholders.
Kristen identified the third prong as the most important and suggested the following theme for the working group: “Better health through better partnerships.”
Next, Tick-Borne Disease Working Group members and those supporting them (the Designated Federal Officer and the Alternate DFO) were asked to introduce themselves. Summaries are provided below.
John N. Aucott, MD
Associate Professor, Division of Rheumatology, Johns Hopkins University School of Medicine; Director, Johns Hopkins Lyme Disease Clinical Research Center
Kristen Honey, PhD, PMP
Senior Policy Analyst, Office of Management and Budget, Executive Office of the President; Senior Research Scholar, Stanford University; Member, Stanford University Lyme Disease Working Group
Other Members (in alphabetical order)
Wendy Adams, MBA
Research Grant Director, Bay Area Lyme Foundation
Benjamin Beard, PhD
Acting 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
Commander Scott J. Cooper, MMSc, PA-C, U.S. Public Health Service
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, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services
Richard Horowitz, MD
Member, World Health Organization’s Ad Hoc Committee for Health Equity
Captain Estella Jones, DVM
Director, Medical Countermeasure Regulatory Science and Senior Regulatory Veterinarian, Office of Counterterrorism and Emerging Threats, 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 Richards, PhD
Director, Rickettsial Diseases Research Program, Naval Medical Research Center, U.S. Department of Defense
Vanila M. Singh, MD, MACM
Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
Patricia V. Smith
President, Lyme Disease Association
Karen Vanderhoof-Forschner, LLM, JD, MBA
Co-founder, Lyme Disease Foundation
Non-Member Coordination and Support
Designated Federal Officer (DFO)
Richard Wolitski, PhD
Director, Office of HIV/AIDS and Infectious Disease Policy, U.S. Department of Health and Human Services
James Berger, MS, MT (ASCP), SBB
Senior Advisor for Blood and Tissue Policy, Office of HIV/AIDS and Infectious Disease Policy, U.S. Department of Health and Human Services
Overview of the Working Group’s Charter
Richard Wolitski, Designated Federal Officer
Rich W. briefly summarized the Tick-Borne Disease Working Group’s charter. As stipulated in the 21st Century Cures Act, the group is charged with reviewing all efforts related to tick-borne diseases within HHS, examining research priorities, helping ensure interagency coordination, and minimizing overlap. The group will compile its recommendations for improving the current federal response in a report that will be submitted to Congress in December of 2018.
The Federal Advisory Committee Act (FACA) and the Government Sunshine Act ensure transparency of the process by requiring the working group to give public notice of any meetings where substantive decisions affecting the Congressional report will be made. The public will also be given the opportunity to comment at those meetings, and all materials (i.e., summaries, presentations, webcasts) will be made publicly available.
Rich W. described the selection process for the Tick-Borne Disease Working Group. Federal representatives from four agencies reviewed the 64 nominations received for the seven public seats on the working group. A set of criteria were used to score each nomination based on the information that was submitted. The representatives made recommendations using a scoring system and strived to ensure a balance of perspectives (i.e., health providers, researchers, and patients). Recommendations were forwarded through HHS, with the Secretary of Health and Human Services making the final decision on the positions.
One public member, Gary Wormser, MD, has withdrawn from the working group for personal reasons. A new nominee from the physician category of the original list of nominees has been selected and currently is under review.
All members will participate in the working group until the submission of the first report to Congress, after which time the terms of public members may be extended by HHS.
Rich W. noted that all member perspectives have equal weight. However, there is one distinction between federal and public members: when unavailable to attend a meeting, federal members can appoint an alternate to attend in their stead to represent their agency.
In order for the working group to consider the broad range of issues related to tick-borne diseases, the group will discuss the formation of subcommittees focusing on specific topics. The subcommittees will not make any decisions or recommendations; their role is to bring issues, questions, and suggestions to the full working group for discussion during public meetings. The content and attendee lists of all subcommittee meetings will be made available to the public.
Rich W. then turned over the meeting to the working group Chair and Vice-Chair.
What We Hope to Accomplish Today
John Aucott, Chair
Kristen Honey, Vice-Chair
As identified by Kristen, one of the goals for the afternoon session was to set aside past debates and controversies surrounding tick-borne diseases and focus instead on creating a safe and constructive space for all stakeholders to voice their opinions. This focus would thus give everyone the opportunity to learn from the experience of others. She also reminded participants that innovative solutions can come from unexpected sources. Therefore, it is especially important for the working group to “expand the solution space” to include a wide range of perspectives, particularly those of patients.
John concluded by reminding working group members and participants to listen attentively and empathetically to all stakeholders. He suggested bearing two principles in mind as others share their thoughts: 1) keep an open mind when presented with disparate opinions; and 2) imagine that the person talking is a loved one.
After a short break, John turned over the meeting to Kristen.
Introduction of Facilitator
Kristen Honey, Vice-Chair
Kristen introduced Dázon Dixon Diallo, MPH, as facilitator for the “Listening Perspectives” portion of the meeting. She described her as a recognized visionary and advocate in the struggle for human rights, the fight against HIV/AIDS, and now the fight against Lyme disease and tick-borne illness.
Kristen then turned over the meeting to Dázon.
Introduction to Stakeholder Presentations
Dázon Dixon Diallo, Facilitator
Dázon greeted meeting participants and facilitated speaker presentations.
Key Stakeholder - Presentation 1
Gregg Skall, General Counsel, National Capital Lyme Disease Association
Gregg Skall, Esq., began his presentation by stating that he is speaking not only on behalf of the National Capital Lyme Disease Association, but also on behalf of his wife, who has struggled with tick-borne illness for more than two decades. He hopes that the working group’s efforts will “bring about significant changes to the state of medicine associated with Lyme and tick-borne diseases.”
However, he sees two major challenges facing the working group. The first involves the lack of communication about tick-borne illnesses within the medical community. While there are many “self-directed and self-motivated researchers [who] have decided to study this complex medical conundrum on their own,” he said, they have been unable to constructively share their findings and collaborate with others. The second obstacle stems from the “poor understanding of the incidence and geographical distribution” of tick-borne diseases, since there is no “accurate assessment of the magnitude of the effect of these diseases on the general population.” Gregg stressed the importance of expanding “our national consciousness…to include the study and treatment of all tick-borne diseases throughout the United States.”
To achieve the greatest impact on the greatest number of people, Gregg made several requests, including development of more accurate diagnostic tools that are capable of detecting all stages of tick-borne diseases and tests that allow better characterization of both acute and persistent manifestations of tick-borne diseases. He also urged HHS to expand its funding for the emerging research that comes from fresh and new perspectives. Gregg also highlighted the importance of considering anecdotal patient information as a potential source of research data. In order to share this and other research findings, he suggested examining ownership and patent rights to ensure they are fostering, rather than inhibiting, research and collaboration.
To improve the lives and health of people living with tick-borne diseases, Gregg recommended several courses of action, the first of which is to discontinue using the current Centers for Disease Control and Prevention (CDC) case definition of Lyme disease as the definitive diagnostic criteria in the clinical setting. Patients, medical providers, and scientists need an expanded definition that includes the “entire emerging spectrum” of tick-borne diseases. He also stressed the importance of developing a national education course for medical providers so they can recognize, diagnose, and treat tick-borne diseases and their coinfections. In the meantime, Gregg urged state medical boards to refrain from penalizing providers who deviate from the Infectious Disease Society of America (IDSA) guidelines in order to treat patients with tick-borne illnesses.
Gregg concluded by recommending methods for preventing new tick-borne infections. These include funding national media campaigns and educational programs to increase public awareness, and screening blood donors for Babesia in order to prevent transmission through the national blood supply. Regarding vaccines, the National Capital Lyme Disease Association supports development of a vaccine that is effective against a wide range of Borrelia strains.
Key Stakeholder - Presentation 2
Lorraine Johnson, CEO, LymeDisease.org
Lorraine Johnson, JD, MBA, a Lyme disease sufferer, focused her presentation on the role of big data in advancing research of tick-borne illnesses. She noted that until now, the National Institutes of Health (NIH) has funded only three small clinical trials on the treatment of chronic Lyme, the last of which took place over 15 years ago. Although “Lyme is a common disease, it still has the research legacy of a rare disease….and has lacked the research incentives essential to make progress,” she said.
In the absence of randomized controlled trials, Lorraine highlighted the critical role that case studies and registries play in understanding tick-borne diseases. She noted that LymeDisease.org’s patient registry, MyLymeData, has collected millions of data points thanks to the participation of over 9,700 patients. Her organization has partnered with researchers at UCLA and Claremont McKenna to explore big data analytics using artificial intelligence. This partnership resulted in an $800,000 National Science Foundation grant to support predictive analytic work using MyLymeData. “This work will begin to answer questions such as what factors can help predict which patients are more likely to remain ill,” she commented.
Lorraine also reported that LymeDisease.org collaborated with advocacy groups, researchers, and physicians to develop a list of the “top ten research priorities for Lyme disease.” The group then sent the list to MyLymeData registrants and asked them to identify the research priorities they considered most important. Over 7,000 patients, researchers, physicians, and advocacy groups participated in the survey. Lorraine concluded her presentation with the following list of research priorities, the first three items being the highest ranked:
- What direct diagnostic test would be both highly sensitive and specific for Lyme disease and coinfections?
- What is the most effective treatment protocol to restore health to patients with Lyme and other tick-borne diseases?
- What is the impact of delayed diagnosis on the course of Lyme disease?
- What natural therapies and protocols are most effective?
- What other diseases (e.g., M.S., Parkinson’s) may be caused by Lyme disease?
- What are the most effective methods for rehabilitating the brain in neurologic Lyme disease?
- Why do some people develop chronic Lyme disease after antibiotic treatment?
- What triggers reactivate chronic/late stage Lyme disease and coinfections after remission?
- How do coinfections affect the immune response and course of illness in patients with Lyme disease?
- Are treatment regimens tailored for specific symptoms (e.g., neurologic) more effective?
Introduction to Public Comment
Dázon Dixon Diallo, Facilitator
Dázon began the public comment portion of the meeting by offering words of inspiration based on her own experiences working with patients struggling with undiagnosed and misunderstood illnesses. She then had participants take part in an active listening exercise. Next, she introduced each of the public commenters, who had three minutes each to talk about their experiences.
The following individuals provided public comment to the Tick-Borne Disease Working Group members.
Colonel Nicole Malachowski
Colonel and Fighter Pilot, U.S. Airforce; Tick-Borne Disease Patient and Advocate
Founder, Livlyme Foundation; 13-Year-Old Tick-Borne Disease Patient
Tick-Borne Disease Patient
14-Year-Old Tick-Borne Disease Patient; Daughter of Amy Fitzgerald (above)
Tick-Borne Disease Patient Advocate
Erica Keys Land
Attorney, Food and Drug Administration; Tick-Borne Disease Patient and Advocate
Physician Facilitator, North Texas Lyme Group; Tick-Borne Disease Patient
Volunteer and Patient Advocate, Lyme Disease Association
Tick-Borne Disease Patient
Department of Defense Employee; Volunteer and Advocate Patient
Many public commenters were tick-borne disease patients who described the following symptoms, which many have experienced for years and even decades:
- Cognitive and speech impairment
- Temporary blindness
- Extreme pain and fatigue
- Ulcers and gastro-intestinal distress
- Anxiety, depression, and suicidal thoughts
Many commenters reported being undiagnosed and misdiagnosed—some for many years—and being refused treatment for tick-borne diseases. Some are on permanent disability or have been forced to resign from their jobs. They report enduring financial strain as a result of having to pay out-of-pocket expenses for treatment. And many feel they are unable to care for their family due to poor health. Several commenters reported experiencing relapses once antibiotic treatment had ended.
Two populations were identified as being particularly vulnerable, the first of which is children. Several individuals mentioned transmitting tick-borne diseases to their children in utero. And two of the commenters were teenagers who don’t recall a time in their lives when they weren’t experiencing symptoms. Colonel Nicole Malachowski also identified members of the military as an especially high-risk population due to its increased likelihood of encountering diseases on the job. She added that when service members like her are forced into retirement, American taxpayers “are not getting the return on investment they should have.…This is a military readiness…and national security issue.”
Public commenters made multiple recommendations compiled below in the order they were presented by commenters. (Redundancies have been excluded for the sake of concision.)
- Provide resources to the U.S. Department of Defense and Veterans Affairs for addressing tick-borne diseases.
- Increase funding to the Congressionally-directed medical research program for tick-borne diseases.
- Establish a new standard for testing tick-borne diseases.
- Fund tick research to prevent the spread of ticks and their pathogens.
- Provide funding commensurate with tick-borne disease prevalence (similar to the type of funding mosquito research receives).
- Revoke the IDSA Lyme guidelines and establish new ones.
- Review the evidence for the existence of chronic Lyme and tick-borne diseases.
- Publicly acknowledge the scientific basis for chronic Lyme and tick-borne diseases, and consider renaming the illnesses, if necessary.
- Conduct further trials of antibiotic therapy or alternative forms of treatment, incorporating both Western and Eastern medicine (peer-reviewed and validated).
- Abandon attempts to develop a vaccine.
- Restrict anyone who denies chronic tick-borne illnesses from participating in the working group.
- Require coverage of therapies by insurance companies.
- Encourage cancer clinics worldwide to integrate treatment for tick-borne illnesses since, like cancer, tick-borne diseases affect B cells.
- Develop sponsored medical care for patients who have experienced financial distress as a result of out-of-pocket treatment expenses.
- Offer autologous blood stem cells to repair the damage caused by Lyme and its coinfections.
- Require providers to remain current with AMA-approved continuing medical education regarding tick-borne diseases.
- Develop a more systematic and comprehensive plan for surveillance of both human tick-borne diseases and tick vectors.
Ms. Dixon concluded the public comment portion by encouraging continued advocacy and turned over the meeting to John.
John Aucott, Chair
John moved to adjourn the meeting at 4:00 p.m. All voted in favor.