TBDWG December 3, 2018 - Meeting Summary
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 by reviewing the agenda for Meeting 8. In doing so, he clarified that during the meeting, the current Working Group would be referred to as “Working Group 2018”; whereas the group that will write the next report to Congress will be referred to as “Working Group 2020.”
Recap of Meeting 7
John provided a summary of what occurred during Meeting 7 (July 24, 2018), which included voting on the final recommendations featured in the Working Group’s 2018 report to Congress, as well as voting on the full report itself. The Working Group also voted to create a new public comment subcommittee made up of Working Group members who volunteered themselves to participate.
ADM Brett Giroir, MD, Assistant Secretary for Health, U.S. Department of Health and Human Services (HHS), offered his congratulations to the Working Group and its subcommittee members on having participated in “the first-ever Federal advisory committee to address tick-borne diseases and conditions.” He added that “never before have such diverse stakeholders come together in a Federal platform to tackle this urgent public health issue.”
The Assistant Secretary noted that when the group first began, he received a tremendous volume of emails regarding the Working Group; however, over time, the emails have decreased significantly, which he attributed to the group’s success in addressing stakeholder issues. He complimented the group on having produced a substantial and meaningful report in a short span of time. In conclusion, he expressed his hope that Meeting 8 will lay the groundwork for the 2020 report.
Recognition and Thanks
John stated that one of the purposes of the meeting is to formally recognize and thank the 14 Working Group members, the subcommittee members, all invited speakers who presented to the Working Group and its subcommittees, and everyone who provided public comment. All of these individuals, he added, helped the Working Group produce a balanced report.
John then stressed that the Working Group’s report to Congress would not have been possible without the assistance of the subcommittees. He reviewed the subcommittee membership structure, duration, and purpose, highlighting that the subcommittee reports were based on expert and patient presentations, advocate perspectives, collective subcommittee knowledge, and informal literature reviews. He concluded that the creation of the subcommittee reports in such a short span of time was a “monumental undertaking,” and he thanked all contributors for their efforts.
John turned the meeting over to 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, who stated that the subcommittee reports can be found in the “Reports” section of the Tick-Borne Disease Working Group’s website (https://www.hhs.gov/ash/advisory-committees/tickbornedisease/index.html). She and John then read the names of everyone who participated in the subcommittees (see below). After each subcommittee was introduced, the respective co-chairs offered their thanks to the members.
Disease Vectors, Surveillance, and Prevention Subcommittee
Co-Chairs: Pat Smith and Ben Beard, PhD
Neeta Connally, PhD, MSPH
Thomas N. Mather, PhD
Colonel Robin Nadolny, PhD
Adalberto Perez de Leon, DVM, PhD, MS
Daniel E. Sonenshine, PhD
Jean I. Tsao, PhD
Monica M. White
Stephen Wikel, PhD
Pathogenesis, Transmission, and Treatment Subcommittee
Co-Chairs: Wendy Adams, MBA, and Estella Jones, DVM
Nicole Baumgarth, DVM, PhD
Pat K. Coyle, MD
Sam Donta, MD
Brian Fallon, MD, MPH
Lorraine Johnson, JD, MBA
Elizabeth Maloney, MD
Jon Skare, PhD
Brian Stevenson, PhD
Testing and Diagnostics Subcommittee
Co-Chairs: Lise E. Nigrovic, MD, MPH, and David Roth, JD
Holly Ahern, MS, MT (ASCP)
Charles Y. Chiu, MD, PhD
Roberta DeBiasi, MD, MS
Noel Gerald, PhD
Deborah Hoadley, MD, MPH
Maliha Ilias, PhD
Bobbi Pritt, MD, MSc
Steven Schutzer, MD
Access to Care Services and Support to Patients Subcommittee
Co-Chairs: Scott Cooper, PA, MMS, and Paula Jackson Jones
Ana Frost, PhD
Robert C. Bransfield, MD, DLFAPA
Colonel Nicole Malachowski
Leonard Schuchman, DO, MPH, FAAFP
Sheila M. Statlender, PhD
Kathleen Steele, LCSW
Enid Haller, LCSW, PhD
Vaccine and Therapeutics Subcommittee
Co-Chairs: Dennis Dixon, PhD, and Robert Smith, MD, MPH, FACP, FIDSA
Felipe C. Cabello, MD
Monica E. Embers, PhD
Maria Gomes-Solecki, PhD
Utpal Pal, PhD
Stanley A. Plotkin, MD
Juan Salazar, MD, MPH, FAAP
Leigh Ann Soltysiak, MS
Other Tick-Borne Diseases and Coinfections Subcommittee
Co-Chairs: Richard Horowitz, MD, and Allen Richards, PhD
Megan Dulaney, MS
Marna Ericson, PhD
Christine Green, MD
Charles Lubelczyk, MPH
Ulrike G. Munderloh, DVM, PhD
Garth Nicolson, PhD, MD (H)
Christopher D. Paddock, MD, MPHTM
Samuel S. Perdue, PhD
Sam R. Telford III, ScD
Kristen concluded the segment by presenting the Public Comments subcommittee (see below), noting that it is the only one still meeting on a regular basis to process the emails received at firstname.lastname@example.org and synthesize them for the Working Group. She highlighted the immense volume of emails received and thanked the members for their help processing them.
Public Comments Subcommittee
Chair: Kristen Honey, PhD, PMP
Richard Horowitz, MD
Scott Cooper, PA, MMS
Overview of Work since Meeting #7
John presented a summary of the work completed since Meeting #7. Specifically, he outlined the final phases of the Working Group’s report to Congress, which had been:
- Copyedited at least four times.
- Sent to the Centers for Medicare and Medicaid Services (CMS), the National Institutes of Health (NIH), and the Centers for Disease Control and Prevention (CDC) for informational purposes. (John clarified that their feedback resulted in factual discrepancy corrections and copyedits only; no changes in content were made.)
- Sent to HHS Legislative Affairs for review.
- Submitted to Assistant Secretary for Health and Congress, specifically the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate.
Communications Plan Summary
Diane Gianelli, Public Affairs Specialist, Office of Communication, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, described the rollout of the Tick-Borne Disease Working Group 2018 Report to Congress. She stated that prior to the report’s release on Wednesday, November 14, 2018, relevant Federal officials and Capitol Hill members and staff were notified; embargoed copies were sent to press organizations that had previously covered tick-borne diseases and conditions; and embargoed interviews took place. Following the release, she added, the response from the press exceeded expectations as several major media outlets, including NBC, CNN, Science News, and NY Daily News, featured related stories. She noted that Chair John Aucott took most of the press calls and conducted several interviews. Overall, she concluded, it was a “great rollout.”
Next, John introduced the public comment portion of the meeting.
Ten members of the public provided comments to the Working Group.
Peg Strickland: Peg stated that, after she presented in the emergency room with stroke-like symptoms, she was diagnosed with alpha-gal allergy in October of 2015. However, she added, her experience in emergency care on two different occasions suggested that health care providers and laboratory technicians are largely uninformed about the presentation and seriousness of alpha-gal allergy. As an example, she noted that she was informed by health care providers on both occasions that anaphylaxis is “always immediate, never delayed.” In her view, drug manufacturers “are often unable to source much-used ingredients, such as glycerin, as animal- or vegetable-derived.”
Peg stressed the importance of reclassifying the alpha-gal allergy as a life-threatening occurrence that involves all mammalian products, not just red meat, and that the “mammal threat needs to be included in the description, the name of the disease, and the literature to health care providers.” She also highlighted the importance of labeling mammal ingredients in all consumer and food products, as well as medications, and informing hospitals, doctors, schools, and restaurateurs about the risks of alpha-gal allergy.
Jennifer Platt: Jennifer began by stating that she has a doctorate in public health and is the founder of TickWarriors and Tick-Borne Conditions United. She encouraged the Working Group to “use many different levers or points of influence to make sustained change in the system,” which she quoted from Leverage Points: Places to Intervene in the System by Donella Meadows. She then urged the Working Group to consider the following “levers change.”
- Consider the impact and opportunities of other ecological players in nature, such as bacteria, fungi, spiders, ants, beetles, rodents, and birds, which, she noted, are “natural predators or limiters of tick populations.” Jennifer added that “large-scale landscape management practices, such as keeping continuous areas of mature forest in conjunction with increased hunting, is a fairly simple and inexpensive control measure.”
- Engage with Federal integrated pest management groups, including the Environmental Protection Agency (EPA), the Environmental Law Institute (ELI), and the Department of Agriculture (USDA), especially, she added, “in light of the growing appearance of the Asian long-horned tick”. She stressed the importance of soliciting increased participation from the public health sector.
- Look to international work in prevention. For example, she noted, Australia’s “freeze it, don’t squeeze it” mantra strives to help reduce tick bite-induced anaphylaxis.
Jennifer concluded by reminding the Working Group to look ahead in order to “minimize potential adverse impacts of today’s decisions.”
Lorraine Johnson: Lorraine stated that she is the CEO of Lymedisease.org and principle investigator of MyLymeData, and that the focus of her comments would be “the use of the term post-treatment Lyme disease syndrome (PTLDS) and how it harms patients.” She explained how the term was created by the Infectious Diseases Society of America (IDSA) and that it was intended as a framework for research rather than clinical application. She highlighted that CDC “has long cautioned against using surveillance definitions for diagnosis because these definitions, like research inclusions, serve a very different purpose and are designed to measure only a fraction of clinical cases.” She then added that surveillance definitions such as PTLDS are designed to exclude the majority of patients in order to ensure methodological precision. She noted that a recent study by Quest Diagnostics and another big data study by FAIR Health both showed that surveillance cases are “dwarfed by clinical cases.”
In addition, Lorraine identified two assumptions of the term PTLDS:
- Patients have received adequate treatment.
- The cause of their continuing symptoms is a post-infectious disorder.
There is no evidence, she noted, to show that either of these assumptions is true. However, she continued, “physicians and insurers use PTLDS terminology to deny diagnosis, treatment, and reimbursement.” Lorraine concluded by highlighting the harm that this terminology causes patients as it often prevents them from obtaining the diagnosis and treatment they need.
Betty Gordon: Betty (from Iowa) expressed her disappointment that the term PTLDS was included in the Working Group’s report to Congress. She recounted that her husband suffered from Parkinson’s disease, dementia, and chronic renal failure, and that two days before his death, he was diagnosed with advanced lung and liver cancer. However, she added, two brain autopsies revealed that he also had Lyme disease, a species of parasitic worm (nematode), and two species of Bartonella. She then voiced her frustration that she could not convince the Department of Health (DOH) to add the illnesses revealed in the autopsies to her husband’s death certificate nor count her husband’s Lyme disease in Iowa’s statistics on the illness. Betty concluded by thanking the Working Group for its hard work and stating that “this wrong needs to be corrected now.”
Deborah Fleshman: Deborah described the difficulty people with alpha-gal allergy have in obtaining medications that are not derived from mammalian ingredients. Not only are there very few medications available, she stressed, safe drugs are often expired, in short supply, in no supply, or are not adequately labeled. She added that alpha-gal sufferers are dependent on the Food and Drug Administration (FDA) for their safety. Yet its medication shortage list contains several drugs that are considered safe for alpha-gal patients, including the EpiPen from Mylan. Her own EpiPen, she noted, is seven months past its expiration date causing her to fret about its effectiveness should she experience a life-threatening allergic reaction. Labeling, she added, is an important issue that needs to be addressed.
Dorothy Leland: Dorothy commented on the issue of “misdiagnosis by geography,” which in her view occurs when health care providers do not consider Lyme disease in their differential diagnoses because they are in a state deemed low-incidence and therefore do not diagnose the disease. As a result, the misdiagnosis can cause patients, she said, to “lose the crucial advantage that comes from early treatment of the illness” when good outcomes are most likely.
Dorothy explained that she is from California and that, in 2005, her then 13-year-old daughter became “mysteriously and seriously disabled” causing her to rely on a wheelchair for three years. Ultimately, Dorothy noted, they found providers who were knowledgeable about Lyme disease and who, through a “long and arduous” process, helped her daughter regain her health. Dorothy added that her daughter’s experience prompted her to become involved in LymeDisease.org and coauthored a book entitled “When Your Child Has LD: A Parent’s Survival Guide.”
Dorothy concluded by citing studies from Quest Laboratories, FAIR Health, and LymeDisease.org that demonstrate a higher incidence of Lyme disease in all 50 states than is reflected in CDC surveillance data. “Our system for tracking,” she stated, “is broken and must be fixed.”
Phyllis Mervine: Phyllis stated that she is the founder and president of LymeDisease.org. Her comments related to the letter sent to the Working Group by Dr. Cynthia Sears, President of the IDSA, on November 26, 2018 (https://www.idsociety.org/globalassets/idsa/policy--advocacy/current_topics_and_issues/emerging_infections_and_biothreats/agency-efforts/112618-idsa-comments-on-tickborne-disease-working-group-report.pdf). Phyllis addressed the concern expressed in the letter about the Working Group’s approach to completing its work. She defended the Working Group’s process and described the composition of the Working Group as well diversified.
In addition, Phyllis questioned the IDSA’s methods for creating the Lyme disease guidelines in 2006, citing criticisms from the Connecticut Attorney General and the Institute of Medicine. In her view, the 2014 guidelines created by the International Lyme and Associated Diseases Society (ILADS) are “trustworthy” because they have met “stringent standards.” She then referenced the MyLymeData project, stating that it “may give us more insight about responders and non-responders to various treatment.”
Kathy Nodolf: Kathy commented that the Working Group’s 2018 Report to Congress was not the result of members of ILADS and IDSA working together “to come up with a joint document that truly helps the victims of chronic Lyme.” She expressed her impression that the Working Group was receiving criticism “from all sides.” She advised the Working Group to disregard the criticisms in Dr. Cynthia Sears’s November 26, 2018 letter. She then referenced several studies that contradict the IDSA’s position on chronic tick-borne disease.
Kathy offered the following quote from a friend: “If you have to be on a healing journey through an alternate universe where you are the failure if you are still sick despite losing your home and retirement to pay doctors who must not be named for treatment you’ve discovered on FB, you might have Lyme.” She then concluded with the question, “Why is this so political?”
Carl Tuttle: Carl experienced technical difficulties when calling in to the meeting and, therefore, provided the following comments via email:
It is no secret that the U.S. Centers for Disease Control has aligned itself with the seven defendants named in the Texas racketeering lawsuit. The CDC has been able to perpetuate this thirty-year illusion that “Lyme disease is difficult to catch and easily treated” through focusing on the acute stage of disease after early treatment.
For example: The CDC financed Gary Wormser’s five-year study of the acute stage of disease to the tune of 1.5 million taxpayer dollars. Published in 2010 known as: Subjective symptoms after treatment of early Lyme disease. https://www.ncbi.nlm.nih.gov/pubmed/20102996. Gary Wormser, New York Medical College
Results: At 12 months after enrollment, only 5 (2.2%) of 230 evaluable patients reported new or increased symptoms, and in none of the patients were these symptoms of sufficient severity to be functionally disabling
Summary of Wormser’s study: Anyone experiencing symptoms after the one-size-fits-all early treatment approach is just experiencing nothing more than the “aches and pains of daily living.” So basically Wormser’s results are then assumed to apply to the entire patient population; in other words, Lyme is no big deal. Purposely avoiding the advanced stage of disease hides the horribly disabled and anyone unable to see this is somewhat naive.
Many infections as I continue to point out evolve into an entirely different and serious life-altering disease when left untreated. Post Treatment Lyme Disease Syndrome (PTLDS) and untreated Lyme of months, years or decades are two entirely different disease states; the latter being ignored for three decades.
What is the motivation for downplaying the severity of Lyme disease while ignoring patient outcry for thirty years? Forty years have passed since this disease was first recognized but we still don’t know how Lyme disables it victim so that we can figure out what we’re dealing with here and how to treat it properly. In other words, the CDC must stop focusing on the acute stage of disease after early treatment. But this has been avoided at all cost to maintain the status quo.
The research into how Lyme disables should have been completed by now but the misclassification of Lyme as a simple nuisance disease (hard to catch and easily treated) has negatively influenced the response to this serious and life altering infection. The U.S. Centers for Disease Control has failed its responsibility to protect American citizens from the devastation of Lyme disease and yet no one is held accountable.
If the Tick Borne Disease Working Group doesn’t recommend the firing of the CDC over the mishandling of a disease that is destroying lives, ending careers while leaving its victim in financial ruin, then we will have another decade of unimaginable pain and suffering. Create a new division within HHS with no ties to the CDC or those named in the racketeering lawsuit; a ‘Lyme Manhattan Project.’
In conclusion I have to ask the question: Is the mismanagement of Lyme disease a result of incompetence or collusion?
Bethany Welch: Bethany experienced technical difficulties when calling in to the meeting and, therefore, provided the following comments via email:
Hello and thank you for this opportunity. My name is Bethany Welch. I was bitten by a female Lone Star Tick in my yard, in Knob Noster, Missouri in July of 2017. Subsequently I contracted the Alpha Gal allergy, which was diagnosed after experiencing a life-threatening anaphylactic episode in August of 2017, while 6 months pregnant. Having this allergy to mammal isn’t as simple as not eating meat. We must be sure none of our medicines, foods, and anything we put on or in our bodies does not contain mammal or mammal-derived ingredients. We must ask restaurant staff for ingredient lists of everything they use, ask them to clean off utensils and a grill spot for us, and then remain seriously persistent when they scoff at what we are allergic to. We must pressure our doctors and dentists to not use mammal-derived dissolvable stitches on us, pharmacists to give us gelatin-free prescriptions. We must be our own advocates because most of the healthcare professionals and the general population have no idea what Alpha Gal is, or even how susceptible they are to contracting it themselves. We need AG specialists. We need proactive care. We need publicity for AG and all tick-borne diseases. We need research funding.
Like I said, I got AG when I was 5 months pregnant. Shortly after my diagnosis I started researching the possibility of my daughter inheriting AG through our placenta. Many other moms have this same question and have taken their babies to get tested for AG. Moms report various findings—some babies test positive for AG but are non-reactive, some thankfully test negative, and some parents get devastating news that even though their babies have never been exposed to a tick bite, they have reactive AG that no one knows how to prevent, or cure. We need AG specialists. We need proactive care. We need publicity for AG and all tick-borne diseases. We need research funding.
Another phenomenon I have noticed while participating in AG support groups is that women with AG are suffering early miscarriages and want to know if AG is a contributing factor, or possibly the main cause. Since contracting AG I have had two early miscarriages. I went to a fertility specialist just last month to present what I know about AG and what I know about other women’s experiences with early loss after contracting AG looking for answers. I presented the theory that the blastocyst expresses AG proteins into the mothers’ body, whose body basically attack it, causing the losses. I was told by the doctor they weren’t sure AG isn’t causing miscarriages, but also, they don’t know much about AG so if it was then they wouldn’t know how to target it to prevent a loss. This is NOT acceptable. We need AG specialists. We need proactive care. We need publicity for AG and all tick-borne diseases. We need research funding. Thank you for your time and all you have done for us.
Discussion from the Public Comments Subcommittee
Kirsten presented the activities and findings of the Public Comment Subcommittee, of which she is Chair. She noted that, since September 2018, the group had been meeting monthly to discuss the more than 700 written comments submitted to email@example.com and synthesize the feedback for the Working Group. Kristen identified the following key takeaway based on public input:
- 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/fresh review of the latest information from across all disciplines/sectors.
Kristen stated that, since the release of the Working Group’s report to Congress, there had been an increase in positive feedback from the public. However, she clarified, the public continues to express grave concerns about certain content in the Access to Care chapter, the discussion in the report around vaccine, and transparency surrounding the entire Working Group process. In addition, Kristen identified the following as common themes in the public comments.
- Improve transparency and opportunities for meaningful public input
- Improve communication, email responsiveness, website update timeliness
- Give people more time to review agendas and draft materials before meetings
- Have Working Group members voluntarily disclose conflicts of interest (perceived or otherwise)
- Make available the raw Federal inventory results for the public to view
- Improve education and prevention for all tick-borne diseases (in addition to Lyme disease)
- Improve diagnostic tests, especially direct pathogen testing
- Improve treatment options for those with chronic illness related to tick-borne diseases
- Evaluate the role of Lyme disease and other tick-borne diseases in other conditions with unknown etiology
Kristen added that ongoing patient suffering was of utmost concern to public commenters who called on the government to make tick-borne diseases and conditions a high and urgent priority. She relayed that, according to public feedback,
- the patient-provider partnership must be a two-way exchange based on mutual decision making;
- evidence-based care and policies must be based not only on rigorous scientific evidence, but also on the patients’ lived experiences in the form of big data;
- and increased funding is essential to progress.
Kristen highlighted that there is great public interest in helping address tick-borne diseases and conditions. She noted that the subcommittee received many emails from patients, medical practitioners, researchers, and students, as well as individuals in local, state, and international governments, expressing their interest in being “part of the solution.” She added that the public strongly supports new ways of thinking about problems, new collaborations, and public-private partnerships.
Kristen thanked the community for providing feedback to the Working Group. She then gave the floor to the other members of the Public Comment Subcommittee to provide additional remarks.
Richard I. Horowitz, MD, Hudson Valley Healing Arts Center; member, World Health Organization’s Ad Hoc Committee for Health Equity, stated that many patients with tick-borne diseases and conditions are blocked from accessing care. He stressed that this is a human rights issue that needs to be addressed urgently.
Captain Scott Cooper, 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, added that all public comments have been taken very seriously and that they are “vitally important to the overall mission of the Working Group.”
Robert (Bob) Sabatino, Founder and Executive Director of Lyme Society Inc., concluded that, while there is always room for improvement, the patients’ voices have been heard.
Timeline for the 2018 Report to Congress
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, presented the following timeline for the 2018 Report to Congress.
|Contractor submitted the final Report to Congress to HHS||October 1, 2018|
|HHS submitted the final Report to Congress to Legislative Affairs||October 2, 2018|
|Contractor submitted 508-compliant Report to Congress to HHS||October 6, 2018|
|HHS submitted compliant version to the Office of the Assistant Secretary for Public Affairs (ASPA) for compliance review||October 8, 2018|
|ASPA approved compliance version of the report||October 18, 2018|
|Report submitted to the Assistant Secretary of Health and Congress||November 14, 2018|
|Final Report to Congress accessible on the Tick-Borne Disease Working Group website||November 14, 2018|
After Jim presented the timeline, Kristen noted that the Working Group will be adding acknowledgments of everyone involved in the creation of the 2018 Report to Congress to the “Report” tab of the Tick-Borne Disease Working Group website (https://www.hhs.gov/ash/advisory-committees/tickbornedisease/index.html).
Transition from Working Group 2018 to Working Group 2020
John discussed what the Working Group could expect in the months to come. He stated that it will be up to Congress and the HHS Secretary to take further action based on the recommendations in the report. He clarified that the Working Group has neither the budgetary authority nor the programmatic status to implement changes; in other words, it does not have the power to spend money or create programs within government agencies. However, he stressed the importance of the Working Group’s contribution, which has been to shine a light on areas of improvement and gaps in knowledge through its report, so that others with budgetary and programmatic authority know where to focus their efforts.
John explained that the “second phase” will begin with the creation of Working Group 2020, which will pick up where Working Group 2018 left off and move forward with new analysis and new recommendations. He added that the new group “will have the latitude to bring in new faces and address issues from a fresh point of view.” He then turned over the discussion to Jim to describe how members of the public can apply to be part of Working Group 2020.
Jim explained that public members interested in applying for a 15-month appointment to the Tick-Borne Disease Working Group should apply by December 14, 2018 at 5:00 pm EST using the instructions on the following webpage: https://www.hhs.gov/ash/advisory-committees/tickbornedisease/notices/index.html. Applications, he stated, would be put through a selection process administered by individuals representing FDA, CDC, NIH, and the Office of the Assistant Secretary for Health (OASH). According to Jim, selected candidates would then be presented sequentially to the Assistant Secretary for Health, the White House, and the Secretary of Health and Human Services for approval. Once approved, he concluded, the candidates would be notified. Jim addressed questions from the Working Group about the membership process, and then turned the meeting back over to John to discuss possible next steps for Working Group 2020.
Possible Next Steps for Working Group 2020/Looking Forward
John described some possible next steps for Working Group 2020 based largely on the “Looking Forward” section of the 2018 Report. He clarified that, ultimately, Working Group 2020 will decide what the best course of action will be, but that the following are some actions and areas of focus:
- Literature Review Providers
- Agency for Healthcare Research and Quality (AHRQ) – highly comprehensive; fees for service
- NIH Library Systematic Review Services – considerably less comprehensive than AHRQ review; no fees for service
- Systematic literature review of adverse effects from over-diagnosis and unsubstantiated treatment for presumed tick-borne diseases
- Systematic literature review of adverse effects from under-diagnosis and under-treatment for tick-borne diseases
- Systematic literature review of unresolved priorities and questions:
- Nomenclature challenges (specifically, chronic Lyme, post-treatment Lyme disease syndrome, co-infection)
- Rising healthcare costs in the U.S. due to Lyme disease, other tick-borne diseases, and coinfections
- Shortcomings and limitations of vaccine and diagnostic clinical trials
- Inclusion of vulnerable and high-risk populations in clinical trials
- Transmission unknowns
- Federal Inventory Action/Updates
- New inventory to the Federal agencies submitted in a timely manner (to include any changes or actions made based upon 2018 report)
- Public-private partnerships and collaborations
- Federal research and activities related to tick-borne diseases
- Incorporation of patient experiences into conventional scientific approach
- Trust building and communication
John then solicited ideas from the Working Group about what Working Group 2020 might emphasize in their work.
Rich stressed the need to expand the discussion beyond the “one cause, one disease” model to include other conditions, such as chronic fatigue syndrome and fibromyalgia, which are diagnosed using clinical criteria that often overlap with those of Lyme disease and other tick-borne diseases. He added that many autoimmune diseases are also linked to tick-borne infections like borreliosis as well as environmental toxins, and that some patients with Alzheimer’s disease have tested positive for spirochetes in the brain as well as various strains of the herpes simplex virus. Rich urged the next Working Group to consider the whole picture of disease, especially given the immense societal burden of long-term disability.
Patricia (Pat) Smith, President, Lyme Disease Association, emphasized the importance of “getting the true picture of Bartonella,” given that it is such a common coinfection with many tick-borne diseases. The question of whether or not it is transmitted by ticks, she added, must be answered. If Bartonella is not transmitted by ticks, she continued, it should be determined definitively how it is transmitted to tick-borne disease patients. Rich agreed with her and added that persistent babesiosis should be examined as well.
In response, Robert (Rob) Smith, MD, MPH, FACP, FIDSA, Director and Co-Founder, Vector-Borne Disease Laboratory; Director, Division of Infectious Diseases, Maine Medical Center, expressed concern that, without precise diagnostic tools to determine Bartonella and/or Babesia infection, people could be led astray.
Wendy A. Adams, MBA, Research Grant Director, Bay Area Lyme (BAL) Foundation, stated that, in addition to doing a thorough literature review, it will be important to include in the analysis the work of community physicians who treat so many of the tick-borne disease patients but whose findings are not always included in academic research.
Closing Remarks and Adjournment
John thanked everyone who participated for their hard work, collegiality, and respect. He commented that the Working Group serves as a successful model demonstrating that people with different backgrounds and views can work together in a positive way to address patients’ needs.
Kristen thanked all of the Working Group members, contributors, contractors, and OASH, including Chinedu Okeke for his work on the Federal inventory. She concluded by reading the Working Group’s values and vision statement.
Pat offered thanks to John and Kristen for their work as Chair and Vice-Chair. She expressed appreciation to her fellow Working Group members, noting that they had “come a long way toward getting together and going in the same direction.” And she thanked the Department of Health and Human Services for its support of the Working Group.
Jim concluded the meeting by expressing his gratitude for everyone’s commitment, cooperation, and collaboration. He added that the Working Group’s 2018 report to Congress is a “huge accomplishment in just eight months.”
The meeting was adjourned at 2:48 pm EDT.
Appendix: TBDWG and HHS Support Staff
John Aucott, MD, Associate Professor, Division of Rheumatology, Johns Hopkins University School of Medicine; Director, Johns Hopkins Lyme Disease Clinical Research Center
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 (Absent)
Captain Scott Cooper, PA-C, 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
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
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 of 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 (Pat) Smith, President, Lyme Disease Association
Robert (Rob) Smith, MD, MPH, FACP, FIDSA, Director and Co-Founder, Vector-Borne Disease Laboratory; Director, Division of Infectious Diseases, Maine Medical Center
HHS Support Staff in Attendance
Designated Federal Officer
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
Diane M. Gianelli, Public Affairs Specialist, Office of Communications, 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