good morning welcome to the tickborne disease working group meeting number 18. my name is jennifer gillison and i'm from kauffman associates and will be supporting this meeting today i'd like to explain a little about the webinar interface you should all see the powerpoint slide in the middle of the screen and you should also see the q a box open to the right of the slide all phone lines have been muted if you need technical assistance during the meeting please type the issue into the q a box and one of our texts will respond to you please note that this meeting is being recorded and i will now turn it over to jim berger dfo good morning thank you jennifer on behalf of kay hayes and i as the designated federal officers for the kickbone disease working group we'd like to welcome you to meeting number 18. with that i'm calling the meeting to order and i'll start out with the roll call of the co-chair and go through with the individual members please indicate when i call your name if you're a president with that i'll start out with david walker i'm here leanne hope this act moving on then to scott palmer commons i'm here angel davey present dennis dixon i'm here sam dante here todd meyers we're here kevin maccalluso president fedor perez de leon eugene shapiro here patricia smith here here excellent we do have a quorum with that i'll turn it over to david hey jim this has been beard i'm here as well oh sorry ben i don't know i missed it okay good morning i'm pleased to welcome my fellow kittenborn disease working group members to our 18th and final meeting i wish for all of us to take a deep breath and reflect on our accomplishments today should it would be a smooth victory map leanne okay thank you david good morning everybody i also want to take just a moment to reflect it's hard to believe that this is our meeting of december 2nd our last meeting it wasn't long ago that we were sitting next through admiral juwah the assistant secretary for health at our tick borne disease meeting in january he underscored for us the importance of tick-borne diseases to himself to secretary azar and to the president he also assured us that our work our assessments and our recommendations matter and as a recovered patient it was very inspiring to hear the admiral state that the time for action is now and here we are today is the day in just moments we're about to take steps to finalize our 2020 tick-borne disease report and submit to the secretary into congress thereafter with the assurance that appropriate action will occur so i'm very excited i'm excited for the public i'm excited for patients for recovered patients for patient advocates researchers scientists providers policy makers industry and all the stakeholders and the potential beneficiaries so we have a full agenda today yet again to collaborate on our final steps and our progress so let's get started thank you so just to recap the meeting 17 i'm sure you all recall our deliberate review and discussion of chapters 1 through 11 and the front and back cover and the appendices and that all the chapters have been approved the agenda we have in front of us is to review the mission vision and values to take time to hear public comments we will have a lime x presentation and then methodically we will go through the final report for 2020 beginning with the executive summary chapter 1 background review chapter 2 methods review chapter 3 tick biology ecology and control chapter 4 clinical manifestations diagnosis and diagnostics review chapter 5 causes pathogenesis and pathophysiology chapter 6 treatment review chapter 7 clinician and public education patient access and care chapter 8 epidemiology and surveillance chapter 9 federal inventory chapter 10 public input chapter 11 looking forward chapter 12 conclusions we'll go through appendices we'll review the front cover table of contents back cover and we'll review the meeting and conclude in terms of the review this will be an approach to final voting to put forth the report the objectives for the overall tick-borne disease working group have been defined by the 21st century cures act and they continue to remain steadfast to provide expertise and review of all efforts from hhs related to all tick-borne diseases to help ensure inter-agency coordination and minimize overlap and to examine research priorities and those duties have included no later than two years after the date of the enactment to review the summary of ongoing tick-borne disease research including research related to causes prevention treatment surveillance diagnosis diagnostics duration of illness and intervention the advances made pursuant to such research and federal activities related to tick-borne diseases gaps in pick-borne disease research also acknowledging working group meetings and comments reviewed by the working group to make recommendations to the secretary regr including appropriate changes and improvements in such activities in research and to solicit input from states localities non-government entities including organizations representing patients health care providers researchers and industry regarding scientific advances research questions surveillance activities and emerging strains and species of pathogenic organism to re-emphasize what is our mission today and what we're going to accomplish we're going to do a final review of the overall report to congress and approve it in its entirety for submission to the secretary of hhs in congress we have seen this slide throughout all of our meetings as a 2020 working group and today it's exciting as i've already indicated that we are at meeting 18 and our goal is to put forward the final report to congress it will be represented on also the tick borne disease working group website and it will also of course be submitted to the hhs secretary and we'll turn it over to our designated federal officer jim berger thank you jim thank you leanne with that i've got i will go over the mission statement division statement core values and then i have one announcement and one request that i will share with that i'll start out with the tick-borne disease working group mission statement its mission as mandated through the 21st century cures act is to provide expertise and to review all efforts within the department of health and human services related to all pitform diseases to help ensure interagency coordination and minimize overlap and to examine research priorities as part of this mandate and in order to provide expertise we will ensure that the membership of the working group represents a diversity of scientific disciplines and views and is comprised of both federal and non-federal representatives that include patients and family members or caregivers advocates of non-profit in the interest of the patient with tick-borne illness scientists and researchers a major responsibility of our mission will be to develop and regularly update the action of hhs from the past present and the future the tick-borne disease working group has one common purpose it's a shared vision it's a nation free of tick-borne diseases where new infections are prevented and patients have access to affordable care that restores health with that i'll move on to the core values there are seven core values first one is is respect everyone is valued we respect all people treating them and their diverse experiences and perspectives with dignity courtesy and openness and ask only that those we encounter in this mission return the same favor to us differing viewpoints are encouraged always with the underlying assumption that inclusivity when diversity of minority views will only strengthen and improve the quality of our collective efforts in the long term next core value is innovation we're shifting the paradigm finding a better way we strive to have an open mind and think outside walks we keep what works and change what doesn't we will transform outdated paradigms when necessary in order to improve the health and quality of life of every american the next core value is honesty and integrity in other words find the truth tell the truth we are honest civil and ethical in our conduct speech and interactions with our colleagues and collaborators we expect our people to be humble but not registered and to question the status quo whenever the data and the evidence supports such questions to not manipulate facts and data and to a particular end or agenda and to acknowledge and speak the truth where we find it the next course value is excellence in other words quality real world evidence underlies decision making we seek out rigorous evidence-based data-driven and human-centered insights and innovation including physician and patient experiences that we believe are essential for scientific and medical breakthroughs we foster an environment of excellence that strives to achieve the highest ethical and professional standards and which values the development of everyone's skills knowledge and experience if core value is compassion in other words find solutions to relieve suffering we listen carefully with compassion and an open heart in order to find solutions which relieve the suffering of others we promise to work tirelessly to serve the greater good until that good goal is achieved the next core value is collaboration in other words work with citizens and patients as partners the best results and outcomes won't be created behind closed doors but will be co-created and opened with input of the american public working together with these core values as our guide we actively listen to the patient experiences shared with us respect the lived experiences of patients and their advocates and learn from their experiences and our pursuit of objective truth across diverse audiences we communicate effectively and collaborate extensively to identify shared goals and leverage resources for maximum public health impact our last core value is accountability buck stops here we as diligent stewards of the public trust and the funds provided by our fellow citizens pledged to be transparent in all of our proceedings and to honor our commitments to ourselves and others while taking full responsibility for our actions and service to american people so moving on i do have that one announcement um the federal register notice that was published on november 4th 2020 amended that the nominations for the 2022 fifth born disease working group congressional report must be received in our office no later than 5 p.m on december 5th of 2020 so if you know of anybody that would like to serve in the tickborne disease working group please provide him that information so we can have good representation for the 2022 report and the next thing i have is i've received a recommendation from the health and human services officer general counsel they basically reviewed the 2022 report and the minority responses and they asked that the authors of the minority responses to consider whether the statements about individual members are actually germane to the minority response and that i remind the authors of the scope of the task that the working group members have under the working group statutory authority since such statements appear to be outside of the scope of the members responsibilities under the statute and so with that i provided that announcement and we did have seven minority responses which was quite extensive so with that i'll turn it over to the public comments thank you thank you at this time we're going to proceed with the public comments we have 30 minutes set aside for public speaking today 10 min 10 speakers are on the docket each speaker has three minutes each just before the time is concluded for each speaker you should hear a chime or an indication that your time is almost up we ask that you please respect your allotted time as is always allowable with public comments the comments are received 24 7 they can be emailed to the tickborne disease at hhs.gov website
written comments can be submitted for meetings and verbal comments are available as can follow the process to have a forum in this setting first up today we have julia wagner right good morning i'm julia wagner president of pa line resource network we see well over 5 000 tickborne disease patients come through our support groups each year and have been number one in cases for years my comments represent their interests and focus on the current draft reports and actions the first topic is regarding the research agenda and three critical focus areas that are missing in my view number one a multi-pathogen focus and biofilm communities most of these patients produce immune responses to multiple microbes this is not a one disease one solution situation multi-pathogen models such as those introduced by the national science foundation should be leveraged in tick-borne disease research the second area is immune dysfunction focus cbd's cause immune dysfunction and impact the severity and course of infection immune compromised patients may end up with opportunistic infections such as chlamydia epstein-barr microplasma and more and we see more and more patients developing mast cell disorders this requires more focus number three inflammation and specifically neurological manifestations including cidp other neuropathies dysautonomia pots neurocytes and cognitive impacts these are severely compromising symptoms that we see often in children and youth and we need to do more to address these the second area is regarding the overall recommendations which focus heavily on longer term strategies but it's imperative that these recommendations also deliver immediate improvements in patient care specifically therapeutic options public health authorities must communicate the spectrum of options the state of the evidence and the critical role of clinicians in individualizing treatments based on the knowledge we have available today patients need options now it is unethical to withhold viable treatments waiting for more research the range of guidelines and published protocols such as combination gaps in therapy should be readily communicated as options for persistent disease the last and final area is regarding access to care and the structural barriers evidence in this section included the ricoh case against insurers and the idsa indicating that one insurer kaiser had settled this section must now reflect that all eight insurers have settled this case charged that the insurers and the idsa conspired and colluded to deny patients access to care our legislative efforts in pa produce significant evidence of such denials and the harm that this has caused to patients immediate action must be taken to ensure the cdc and other federal agencies accurately reflect in their content the broad spectrum of treatment options available without bias and stresses the need for individualized treatment options insurers should be made aware of this shift to address the structural barrier and improve access to affordable care that restores health that concludes my remarks thank you lucy barnes yes ma'am good morning i think many will agree 2020 has been a rough year things just aren't copacetic anymore in so many ways and to make matters worse we must now deal with this final report from the tick-borne disease working group that brings me to the word hijack hijack means to take control of or use something that does not belong to you for your own advantage what was originally designed to help society and more specifically to help blind patients is only serving to hurt them with its attempt to retain the highly objectionable and unacceptable status quo we've been trying to work with the government employees who have never treated a lyme patient much less a chronically ill lyme patient what's that about since they put themselves in charge they've had 40 years to make things right and have totally failed to do so we still have no accurate tests a lousy reporting system a restrictive treatment regimen that has failed millions a prevention program that fails to prevent and little to no insurance coverage we have government approved treatment guidelines that are responsible for people developing a chronic illness disability and causing deaths and there are other members of this group that have never treated chronic lyme or had chronic lyme so they have absolutely no personal insight or clinical experience with it why are they here hijacking this effort when you come right down to it it is not our thoughts in this report it is not our words it is not our wishes it is not our concerns it is not our science it is not our votes and it certainly does not speak to our needs the contents of this report is not our message or even a true message it is the government's message being sent back to the government it is a flawed incomplete super minority report at this point because we the patients are the majority and once again the millions who are suffering have not been adequately represented by most of this group's members we've all been hijacked all of us the general public are medical professionals honoring their oath to first do no harm innocent people who have contracted lyme disease patients who have gone on to develop chronic lyme disease and anyone who has tried to honestly help us our science our principles our honor our commitment and our loyalty to chronically ill patients has been picked apart dismissed and well ruthlessly hijacked um i highly recommend the final 2020 tick-borne disease report be rejected in a vote today for not for first not following the group's mission and new members be put in place to develop an improved version a truthful version a version written by people who care people who know the science people who know the disease and people who have not been hijacking this monumental effort for their own purposes thank you thank you christina bauer hi good morning thank you for the time to address you today and to all those who fought for patience this year we all appreciate your time and efforts my name is christina bauer and i'm the director of texas slime alliance and a board member of mothers against wine the tickborne disease working group has been set up to help patients but the voting records of only two of seven special government reps chosen by hhs has been shown to represent the interests of patients instead of choosing federal employee voting members whose primary interests focused on improving the health of blind patients hhs selected a preponderance of dogmatic deniers of persistent lyme disease as documented by the u.n report from the ad hoc committee for health equity in icd-11 borealosis codes dr shapiro denied care to children who later required multiple surgeries caused by the complications of untreated chronic lyme infections why is he on this board in spite of numerous protests of lung disease patients and advocates shapiro was allowed to serve as a non-governmental voting member cdc's david walker a federal government employee who was appointed to co-chair this group represented the sharing voting preferences of eugene shapiro and even voted for this non-governmental representative when he was unable to attend meetings which was often this year the u.s government recognized lyme as a protected pre-existing condition it's effective chronic under the aca in 2012 aca accepted lyme as a chronic illness and unrest restricted treatment in 2012 when the connecticur benchmark plan was accepted into the aca health insurance marketplace why hasn't the working group upheld these lyme protections according to federal law studies on persistent line started in 1988 suggest that we could have prevented congenital lyme in my family of four children and countless more if the government would have acted proactively spearing all research money to study complex persistent lyme disease instead of the fictitious and harmful myths of post-treatment lyme disease syndrome ptlds will stop wasting taxpayer dollars and save countless of lives there are 15 lime codes in icd-11 formally accepted in the world health organization and 194 nations yet many working group members still repudiate the science validating most of these codes as you write the final report to congress think of your greatest love catching lyme disease will you push progress for patients then stop politicizing our children's health and future and do something to stop this generational disease and prevent suffering on a massive scale in the united states thanks for listening and good luck writing your report as i hope that it will represent patients not the government and the launch of a vaccine we need better prevention than relying on a vaccine such as in the one health approach thank you thank you amy lebron my name is amy labeouf and i would like to focus on one of the edicts of this committee prevention of tick-borne diseases six years ago my son jack was a healthy eleven-year-old boy who played tournament soccer hung out with friends went to school and hardly had a care in the world and then one day he wasn't his illness began with flu-like symptoms extreme fatigue and debilitating abdominal pain it progressed into multi-systemic symptoms including temporary blindness he went from athlete to wheelchair to hospital bed and missed over a year and a half of school over the course of two years no one could explain what was happening to him the only two incidents i could remember just before he got sick were a tiny scratch from a stray kitten and a tick that we found in his bed that had hitched a ride inside on our dog we saw 40 doctors across 19 different specialties and no physician ever asked about exposures to animals or insects eventually we found our way to physician scientist dr bob moziani and veterinary internist and vector-borne disease researcher dr ed breitschwert they had been to working together for years using a collaborative one health approach one health looks at health through the lens of the inner relationships among human animal and environmental health dr moziani determined that jack had a barnalosis a vector-borne disease after three and a half years under his care our son has almost fully regained his health i cannot even think what might have happened had we not found this team of doctors and the one health approach that saved his life as a k-12 educator of 20 years i have realized that what happened to my son could happen to any child and that my students like jack are not being taught about vector-borne diseases and zonoses nor how to protect themselves data indicates that cases of diseases from mosquitoes ticks and fleas have more than tripled with lyme disease alone diagnosed in 200 students every single day children are losing their childhoods and we absolutely must do better as chair of the u.s one health education task force i believe that students could and should receive a more comprehensive understanding of health the national health education standards do not explicitly include education about vector-borne disease zoonosis or strategies to prevent them yet education is the key to providing stories excuse me preventing stories like my sons there is still much confusion surrounding kick and other vector-borne diseases but what is not confusing is the critical need to prevent them we must educate students and teachers about these diseases and how to prevent them i implore you to address this vulnerability by including in your recommendations that one health be incorporated into the national health education standards to teach children about zoonotic and vector-borne diseases including basic vector biology vector-borne disease prevention strategies and a conceptual understanding of how human behaviors contribute to expanding vector terrains and more sick people arming students with this knowledge is a powerful way to prevent tick-borne diseases thank you thank you lorraine johnson good morning i'm lorraine johnson the ceo of lymedisease.org as this term of working group draws to an end and the selection of new panel members begins i want to focus on transparency and fairness and the selection of public members of the working group healthcare policy researchers point out that what is to be decided is often already decided the selection of the deciders this working group saw contentious content battles and patients watched in horror as the only sliver of this report relegated to them chapter 7 was on the chopping block passing only by a narrow vote had this chapter not been approved the voice of chronic lying patients whose efforts helped create this panel would have been entirely suppressed defeating the legislative purpose of this group we understand that public members are selected by key federal members on the working group presumably their appointment should reflect the group's core values transparency compassion respect and working with patients as partners yet there was no transparency in the selection process for this group for example the idsa announced dr eugene shapiro's appointment long before the hhs's public announcement shapiro's reputation for making fun of sick patients is neither respectful nor compassionate nor was the public told that which individual legislative roles members fulfilled or why the number of patients from the group was reduced from three to one pat smith the other two patient slots were taken by an academic researcher and a panel member who identifies as an industry representative although the legislation does not provide for such a role she is neither recognized by nor accountable to any patient group only recently were term limits for the members posted on the website all except three expire today the terms for saltisiac and walker don't expire for six months why the special treatment for these two who will watch out for the patient interest during the six-month time period baccaluso represented patients replace patient bob sabatino who in turn replace another patient by charter replacement serve the remaining term of those they replace there should be no out of sync panel appointment patients ask one that the new panel include three members recognized by the patient community as being capable of representing the patient interest in short patients nominated by advocacy groups two that term limits for members of any working group session expire on the same date three that the full slate of group members be publicly announced specifying each member's legislative role and term how else are patients to evaluate whether the full panel is fairly constituted and whether the patient interest is adequately represented thank you for your time thank you jennifer platt first congratulations on the report to congress it's a tremendous undertaking on one of the most critical public health issues of our time second i encourage hhs to further clarify membership expectations every board i've served on has an attendance policy if you miss a certain number of meetings then you're out this is especially vital for time limited initiatives or those that strive for consensus when a member repeatedly doesn't fully participate it disrespects the patient community for whom this entire effort even exists third to add to the comments on patient representation and the problem that many experience chronic symptoms the group's next round of membership needs a variety of representation from patients as co-founder of tickborne conditions united i am based in north carolina and i regularly hear stories that lead me in tears from people who suffer from lesser known conditions such as alpha gal syndrome thabesia and erlichiosis i feel like we have a giant puzzle to solve and we're not looking at all the pieces and how they fit together when we look at problems in artificially created silos instead of holistically we miss important pieces academics call these big complicated problems wicked problems dealing with such issues that have multiple layers of problems requires multiple layers of solutions chronic symptoms are also experienced by non-line patients they too are not getting well the parallel of today is those now diagnosed with quote long-haul covid i hope the growing recognition that a subset of covid patients experience chronic symptoms can be parlayed also into research on diagnosis testing and treatment for tick-borne diseases because so many of us experience ongoing or even a resurgence of symptoms over time i'm a personal example of that this year when i was sick with recurring symptoms for months i was originally diagnosed with early geosis in 2011 but years later discovered evidence of lyman babesia these diseases don't even match up with the tick i know bit me indeed this happens to patients thousands of times every year across the southern u.s the preponderance of the disease is diagnosed like lyme and the rickettsias don't match the preponderance of the ticks that the cdc purports carry such diseases what are we missing the pieces of the puzzle don't yet fit together i assert some of the pieces aren't even on the table yet unless every one of us strives to think more inclusively we may very well continue spinning in these circles where our imaginary cylinder problems remain unsolved i encourage us all to keep inquiring as we begin to prepare for the membership of the next group in its report congress what and who are we missing thank you very much for the opportunity to speak today thank you janice sutton yes hi good morning i'm the registered nurse whose daughter has been fighting bartonellosis as well as medical neglect for seven years why are our beautiful children and their lives being sacrificed for an antiquated corrupt ideology from the idsa the human carnage from systemic tick-borne diseases is exacerbated by outright medical neglect we are forced to struggle and to fend for ourselves as there is no legitimate medical guidance i'd like to share some real stories of individuals with the dual diagnosis of tick-borne disease as well as medical neglect rafaela 19 tick-borne disease in asheville north carolina is unable to attend school unable to get a proper diagnosis in nc in desperation her mother brought her back to her country of origin turkey where she finally got a proper diagnosis of tick-borne disease turkey of all places is better than the u.s
her vision is failing at 19 and i fear that the bartonella is causing optic nerve ischemia as my daughters is natalia a 40 year old beautiful african-american hairdresser lying bartonella 22 visits to the er in north carolina a friend finally told her to check for lyme disease the internist did the lab work finally and then told her something that really friggin haunts me you are positive for lyme but i cannot treat you because it's been in your body for too long and she promptly turfed her her symptoms were over a year 100 pound weight loss headache pain the bart crazies disturbed sleep nightmares and heart palpitations natalia also attempted suicide and lucky for all of us she was not successful she found a phd microbiologist to treat her she and her husband have lost everything cars and apartments due to the expenses she said to me it's evil janice it's just evil what the doctors are doing to us john 14 and his mom in rhode island both positive for tick-borne diseases for three years he was wheelchair-bound due to bartonella neuropathy homeschooled and has spent over a hundred thousand dollars for both of them they are receiving ivig and now doing thought in desperate attempt to find healing and regain their lost lives the prestigious brown university in providence rhode island who is affiliated with lifespan hospitals has stated quote scientists at brown university have predicted that more than 2 million people in the u.s could suffer profound disability from post treatment lyme disease syndrome by the end of this year so there is a very strange and inexplicable disconnect from what these scientists at brown with the lifespan are finding and what the lesbian rhode island hospital doctors are doing within that organization two and four lyme victims so that brings me to the lawsuit of tory versus infectious disease society of america eight insurance companies have agreed to settle the case shapiro and others are guilty in this in this suit for um colluding with the insurance companies so they won't so they prevent lyme sufferers from getting lyme treatment what the heck get him off the group get him off the group he represents you for your time yeah thank you for your time you're welcome betty gordon hi i'm from iowa i've been very disappointed from this committee monopolized by the idfa cdc nih mentality thinking and the conflict of interest agendas and a constant attacks to our lone patient rep pat smith i read where three of you specialize in rexydia not lyme disease david gene and kevin david walker you owe pat smith a sincere heartfelt apology for your rudeness tour at the entire last meeting your behavior was that of a toddler with its favorite toy being taken away you attacked pat during this meeting in the many meetings prior so glad that pat let go saying what was on our minds and many thousands of us patients here in america it was ridiculous one patient rep while we had four the first meetings to have to contend with the three or four of you constantly attacking her the odds were stacked against pappy you didn't pull the wool over her eyes she was vocal each time you tried something when bob serentino's time was up another patient rep should have been appointed not the first that was the next committee needs four patient reps including one of our eyelash treating doctors cooper thank you for my heart preparing with pat on the patient committee you two complemented each other very much also thank you sam donta as a former treating doctor you were a real asset on this committee and calming things down many times jane wasn't at many meetings this year walker voted for him each time and didn't advise the committee about this prior to someone questioning why he was voting for the two people unacceptable future meetings please ask callers to have their dogs in another area from the phone so we don't hear them barking my late husband jack gordon died november 13th 2014 from two tick-borne diseases lime and bartonella two species plus the cluster of 24 nematodes parasitic worms having lyme inside of them plus lewy body dementia causing his visual and violent husbands like robin williams had these four things were found in the two brain autopsies i had done on him jack was never diagnosed with any of these diseases i've tried for five years getting jack's death certificate amended to what his two green autopsy show with no progress iowa department of health told my lawyers they would fight me on this involving iowa's attorney general's office costing me thousands of dollars why he wasn't added to iowa's line state statistics either the books were closed it'd also be nice if in your public comments would be require people to write short paragraphs double spaced would you require that in the 2122 committee so we neurocognitive patients like me misdiagnosed for 35 years by 40 to 50 doctors to be able to read and comprehend their posted letters to the city thank you very much teddy gordon from iowa and thank you to the committee members who did do a good job on this thank you holly ahern uh good morning based on the proceedings of this tick-borne disease working group and the release a few days ago of a new set of medical guidelines which are really not new at all the need for an unbiased evaluation of all the available science related to lyme disease has never been more apparent the intent of the legislation which directed hhs to convene this body as it was originally drafted and passed nearly unanimously by the house in 2016 was to empanel a group with diverse viewpoints to do a deep dive into the myriad of issues surrounding lyme disease diagnosis and treatment for reasons that remain unclear but are undoubtedly related to the decades-long and contentious battle between lyme disease patients and the nih and cdc the language that became law was changed to encompass all tickborne diseases however as specified by dr anthony fauci in an article published in the new england journal of medicine in 2018 lyme disease alone represents 82 percent of reported cases of tick-borne illness in the united states lyme disease should therefore encompass at least that much of the work done by this body new cases of lyme disease exceed those of most other infectious diseases in this country a significant proportion of lyme disease patients develop a long-term debilitating illness which the prevailing medical guidelines labels as medically unexplained symptoms the newest iteration of the guidelines further state the question remains whether patients with these highly heterogeneous symptoms but no alternative diagnoses should be treated as if they had lyme disease in the opinion of some treated for an extended period of time no high quality studies have addressed this question having served on the testing and diagnostic subcommittee of the 2018 working group i can confidently assert that there is no diagnostic tool available that can accurately discern people who are actively infected with beryllium or dorfry from those who are not although this is always stated in reverse it is therefore not possible to know whether patients with highly heterogeneous symptoms do not in fact actually have lyme disease so how then do you define or design a high quality study when you can't accurately discriminate your cases from controls or reliably determine whether antibiotics are an effective treatment since there is no actual endpoint or confidently declare that chronic lyme disease is not actually lyme disease at all and the answer is you can't denying patients access to healthcare based on results of blood tests known to be inaccurate on poorly designed clinical studies and on decades-old medical bias that active infections produce only a few rigid clinical signs is discrimination deeply institutionalized discrimination better science is available and it's time to move on thank you that concludes my statements thank you mira shapiro my name is myra shapiro and i'm a chronic lyme disease patient biostatistician and data scientist who works with lyme disease.org and their myelin data patient registry i also have more than a decade of experience consulting on multiple government health care projects although there's an excess of 400 000 new cases of lyme disease annually it is a disadvantaged disease from a research perspective today i would like to discuss lyme disease research and how as a community we need to work together and bring data from disparate sources to bear to move research forward to better understand test for and treat lyme patients from acute to chronic forms there are many types of data that can be used for healthcare research some that people are most aware of are clinical trials results patient charts and medical records in addition patient registries like my line data and those other specialized surveys can be the stars of a research study are used or used in conjunction with other sources serum and tissue banks autopsy reports and social media content are also valuable sources of data that can be incorporated into research design these different types of evidence should be viewed as complementary rather than competing all evidence types have strengths and weaknesses with advances in technology we're able to harness vast amounts of data from many sources and multiple forms to create valuable usable information applying statistical machine learning and artificial intelligence techniques to these collections of data will allow us to create research designs to accelerate our ability to understand the lyme patient population while at the same time protecting most important patient privacy greater volumes of data will allow us to better understand the path to diagnosis patient profiles and treatment successes and failures informing better disease identification and patient-centered care and treatments although there are differing opinions in the lyme community i know that we can agree that we want patients to get accurate diagnoses and treatments that improve their conditions and quality of life and reduce the burden of disease on society in general the new tick-borne disease working group will be convening in 2021 i hope that one of the priorities will be encouraging and insisting the medical and healthcare research community to leverage the wealth of available data to fuel a lyme disease research engine that focuses on patient-centered research and solutions thank you very much for your time thank you i will turn it over to david walker thank you liam i'm pleased to introduce dr kristen honey who is a senior advisor to the assistant secretary for health and chief data scientist she also served as co-chair of the 2018 tick-borne diseases working group and so she understands exactly where we stand today i look forward to her presentation on mine innovation and lamech's public private partnership lester honey uh thank you very much can uh can you hear me hopefully yes okay um excellent um so yeah saying thanks to the whole tick-borne disease working group and to all the patients advocates and those who have spoken up and shared their experiences over the past 18 meetings um one thing that has really become clear through your voices and recent acts and new legislation by congress is that there's a big problem here that needs solving with lyme disease and it's about 80 percent of tick-borne diseases 70 of vector-borne disease when you're looking at this big ecosystem and many different diseases lyme is a huge problem for many many americans um so what we have done from health and human services is try to address this complex multifaceted challenge from multiple angles next slide please in response to the 2018 report um there were there were many recommendations as you all know and turning these recommendations into concrete actions to have an impact in the real world was really what uh the office i was with in the office of the chief technology officer aimed to do so soon after that report was published in november 2018 um the immediate office of the secretary with the chief technology officer in collaboration with other parts of hhs launched what we call the line innovation initiative this was about using collaboration data-driven innovation emerging technologies and strategic partnerships to accelerate progress in this complex area i have to give a huge shout out to the community because this was not an idea that came from government and the top down this was built on the shoulders and years of work from from the community including we heard lorraine johnson and lyme disease.org leading crowdsourcing efforts to identify uh top ten priorities of the diverse lyme community many patient voices reflected in that we had data scientists self-organizing with hackathons across the country mit hacking medicine harvard stanford berkeley hosted many lime innovation hackathons there was huge community momentum and a clear need for this so what we did was connect the bottom up uh effort and the bottom up kind of signals and trying to develop community solutions with top-down spotlight recognition there's a problem and the intent to hopefully uh improve you know increase lyme disease and a priority but also through funding with the top-down approach we have resources um and when when real transformative change happens it's where the bottom-up community needs connects with top-down priorities and resources next slide please so with this um this two years later um has evolved into a 25 million dollar what we're calling lime x innovation accelerator this was recently launched in uh in october publicly announced in october at the limelight conference many of you i think were uh were participants or online uh viewers of the my mind conference and um what they rolled out was this new collaboration between health and human services or hhs and the stephen alexander cohen foundation this is the largest lyme disease public private partnership in history and our intention behind this was getting started with the lyme innovation and smaller scale events we had round tables we had listening sessions we did a lot in the community validated over two years that yes there's a new year we need to go bigger we need to like have orders of magnitude more impact here since uh the 2018 time the k hagan tick act has passed as you've heard that was in 2019 that was when congress uh authorized 30 million new dollars every year for five years for vector-borne disease lyme and tick-borne diseases being a big component of vector-borne disease it's important to note that that the cahagan tick act was uh 30 million dollars a year authorized by congress authorized means that they have given approval to spend the money new money in this way but no dollars have yet been appropriated by congress so the kayhagen tick act doesn't yet have money behind it to implement at this time um new money behind it and if people want to unlock that it's congress you talk to it is not hhs it is not cdc it is not nih we cannot control the budget but what we can do is decide not to wait for congress appropriations to come we know they're coming at some point we don't know when but we know it can take a long time so this is when we started to get creative and look at other sectors and other resources and public-private partnerships can really really be a force multiplier and an accelerator on how to get things started immediately leveraging the strengths and resources not just of government from but from other sectors so for this lime innovation or lime x innovation accelerator we took a playbook from what we call the kidney x innovation accelerator and that was started uh two years before our launch and really the first ever grand prize challenge where tens of millions of dollars are put up on a uh aryan medicine that is stagnated and you haven't had market innovation for a long time and the quality of life and outcomes for patients is poor kidney care is very much that dialysis has not changed in the past 40 years we're using 1970s technology you could also argue that lyme disease is using 1980s technology and things have not moved forward in the diagnostic space the treatment space and when we put a spotlight on that it really that can accelerate progress and this is not just unlocking government dollars but most importantly what kidney x taught us is that when hhs put a spotlight on the challenge of kidney care private industry and venture capitalists and angel investors took it as a signal if this is a priority for the federal government therefore to unlock a lot of private capital so the kidney x innovation accelerator was a 25 million dollar initiative but it ended up unlocking a lot more dollars from other private sectors they just uh hhs and their their kidney x partnership was the leader and leaning into that to to catalyze change we took that playbook we um through many iterations and events talking uh to people within government outside of government came up with the three focus areas that you'll see here patient-centered innovation education and awareness and the next generation diagnostics patient-centered innovation because clearly we need to there's much more to do in listening to your stories learning from your lived experience learning from from all the different types of evidence out there and lived experience they may be individual anecdotes but when you crowdsource those into 15 000 you know patient records and in um in patient registries that's data that's translating experiences into quantifiable things that we can we can you know find new signals and new patterns in but doing that around the patient experience is a pillar of this work the second area we're going to lean into is education and awareness there's very there's no disagreement or very little disagreement about needing more education and awareness to all stakeholders so we'll be doing a series of events around this it's a series of um kind of unconventional approaches to education and awareness using crowdsourcing citizen science and prize challenges meaning you know you put out like an x-tri style the first group or the the group that does this the best will will receive uh award and then the most i think important and impactful area of the space is the next generation of diagnostics there are many many many diagnostics in the you know technologies that are on the market and emerging the faster we can accelerate this and get the new generation of diagnostics through the regulatory process so that they're actually meeting all fda standards this will be game changing we will be able to have a more nuanced discussion about whether folks have active burley infection co-infections whatever it is right now with diagnostics we're kind of flying blind so um we want to update um the the diagnostic space and again this is not as a science grant um this is putting out a grand prize challenge the first companies or innovators entrepreneurs to deliver solutions that meet certain criteria will win the the grand the prizes i should emphasize that limex does not in any way replace or supersede other government programs that are focused on ticks or tick-borne diseases uh first for all of cdc's prevention and control that continues full steam ahead nih is investing in basic science full steam ahead the office of the assistant secretary for health running this tick-borne disease working group full steam ahead this is another work stream and another way to tackle this multifaceted challenge next slide please so how can you get involved if you're a patient a caregiver a loved one a clinician who sees these complex cases and they don't really match up with some of the peer-reviewed literature how can we engage hhs in collaboration with many external folks and other health issues have developed this model that we call health plus it's a framework and an ongoing um uh set of touch points where it puts people and in this case patients at the center to do uh to understand it from all different perspectives using human centered design and it goes through different cycles we've done this with indian health services and their i.t modernization hhs has done it with sickle cell and we think this model is great for lyme disease so it is a it's a bunch of different work streams and a bunch of different um you know elements to this complex health health plus model in the slides you'll see a link um on this uh uh to a website gives you many many more details but the gist is we hired neutral third-party contractors who will go out in the community and listen to you and then they will they will uh roll up dozens sometimes over a hundred interviews into common themes or what we call archetypes or personas where the pitfalls and the challenges that you know that typically happen across these many many different people and where do those pain points align with the levers and the different things that government can do to fix them so this is a labor-intensive process and we need a lot of people to be interviewed and volunteer for to be interviewed and share their experiences again this will not be hhs interviewing it'll be a neutral third-party organization so you can share candidly and the information will be rolled up by neutral third parties not by government and then their outcomes will be information for government to consider and potentially respond to so i will um the next slide give some details of how to engage specifically um and uh right here you can have your voice heard going to the website limex l-y-m-e-x dot proudicity.com and is on this slide and uh you know the slides will be available and are are available on the tick borne disease working group um and once you go to that it's an open innovation crowdsourcing platform so anyone can sign up for free share their experiences sign up for an interview offer you know why you want to participate in this we also wanted to build on the bottom up community momentum that lyme disease.org
and many of you did over years i believe 2015-2017 a series of events and crowdsourcing efforts that ultimately turned online virtual and i don't it was thousands of folks participated and then out of that came a paper with top 10 research priorities so we see that this kind of what are the priorities with those top ten because we want these efforts to build upon what is already known but there can be you can add your own submissions you can do more but for right now the number one thing you can do in engaging with this health plus model you know if you have lived experience that you would like to share through a different work stream beyond the tick borne disease working group is go to limex dot crowded city.com sign up and then submit your information for an interview um there's a couple other quick things i'll run through uh for more the tick borne disease working group and the feds at a high level and then if there's time happy to take questions so next steps on the government process with limex how are we doing this um we uh under the leadership of admin jawa the assistant secretary for health are revising and updating our internal memorandum of in uh understanding for defining the roles and responsibilities of the different operating divisions staff divisions and offices within the department um and so you will be seeing that soon we'll do the same process as you know we did before well we'll socialize it get everyone's okay before putting it through the executive secretary process so internal mou coming your way soon to the hhs votes we are also we've drafted a diagnostic a lyme disease diagnostics request for information in rfi and what we hope to do is put that out sooner than later for about 30 days so that industry and academic groups and innovators out there can tell us what lyme disease diagnostics they have on the market they're working on will soon be in the market and also hoping to capture with the covid diagnostics you know hhs and american taxpayers have invested nearly two billion dollars on coveted diagnostics and we've gotten really far really fast some of that technology some of those scientific discoveries and insights will be repurposable and and help advance diagnostics in other fields we want to put out rfi diagnostics to get a better understanding of the the full ecosystem today with lyme disease and what's on the horizon in the future that information will help inform our very first uh the lymex diagnostic moonshot we have three focus areas one of them being the diagnostic space and then in terms of timing um we expect our first prize challenge to be uh in early um probably second quarter of 2021 it will probably end up focusing on education and prevention in the beginning uh but the stakeholder engagement the health plus model all of that has already begun um and the diagnostics work will kick off with rfi and that is that's the conclusion if you have any questions please feel free to reach out to me my direct email is at the bottom there as well as with the instructions on how to engage your crowdicity and i thank you all for for like granting me this time and also for for sharing your voice and being a part of this because limex will become a success because many diverse voices engage and um and we hear from everyone but thank you well thank you dr honey for sharing the information about this novel opportunity and uh thank you for your role in and seeing it's overseeing its development i think we can take time for a couple of questions now if they're members of the working group would like to address any questions now please do this is pat kristen thank you so much that was informative and first and foremost i want to thank you and john alcott for your leadership in the first working group i we really appreciate that uh but my question is that what i'm hearing throughout the community is the concern is with the amount of money involved is what kind of control will the government have on the bottom line of the monies i mean there's obvious concerns because of positions taken by uh government agencies and so on with with lyme disease in particular uh that somehow uh this is not going to work out well um for chronic lyme patients so is there a way to determine um what a role the government will play uh over in oversight of of those monies and how they're distributed for what particular projects thanks pat um excellent question and what we are doing is following the kidney x innovation accelerator model and what that did was created a new um entity kidneyx.org so this would be limex.org that does not represent government and does not represent the stephen and alexander cohen foundation it's a quasi-shared interest a mutual interest and we'll be standing up a limex steering committee and ultimately if we follow the kidney x playbook this one x steering committee that again won't be government won't be stephen alexander cohn foundation there will be people that are approved by both of them this steering committee will be the the final approvers of you know uh what what um to focus on how to spend the money and uh green lighting the the final or the ultimate um uh prizes the grand prize challenges where we put out the challenge what the criteria are and then uh open it up for any solvers to deliver the solutions um uh and so there will be multiple layers beneath the line next steering committee um for you know we'll have an internal government um you know uh subject matter experts who can inform and advise up we'll have a formal like you know um scientific advisory board with external folks but ultimately those financial decisions will be will be determined by the cheering committee thank you we have any other further questions at this time it's not thank you dr honey and i think people probably will be taking your advice and contacting you directly as you have instructed us how to do that now thank you excellent thanks so much bye-bye and we'll turn things over to jennifer can listen good morning everyone so we have sent out um the pdfs with all of the changes that have been requested for each of the chapters so the first one we have is the executive summary we'll go through for the executive summary it was approved with editorial changes so we'll show you what those were so this text here was revised um revised not revived sorry revised um during the november meeting so this is what is reflected in the yellow highlight the second change was here um which was for the tenfold to 100 fold and then this here this sentence was revised by ben per the discussion at the november meeting this text and to prevent death was also added for the at the november meeting and then the agency names were reviewed and corrected wherever they appeared in the report for the november meeting we did not receive any additional changes or editorial edits so those are the changes that were made for the executive summary any questions jennifer this is leanne i recognize we can enlarge our screen on our end but could you also try to enlarge it on your end as well that would be greatly appreciated thank you okay so no questions about um that one uh are you ready to go into the background yes please okay so the background chapter was approved with uh no changes so we're just showing you the background um in the template this is the first page here which is a little bit harder to see since it's so enlarged the table that continues to the second page and then finishes here at the top with the references and then the figure that's on the next page uh we did reformat this it looked in the uh november meaning that there were three different paragraphs that they were to be combined so that's what is shown here is the one combined paragraph no edits or text was changed in it just the format and then continues here and moves over and that is what the background looks like are there any questions with the background okay are you ready to go to method yes please oh message section was also approved with no changes so we're just showing you the methods and the template so we've got the topic development briefs the subcommittees that go to the next page and then the information for federal inventory this sentence was revised based upon the information that we received from the dfo and the office so this is what the text now reflects the statement for the federal inventory in the 508 compliance so this is how people can get a copy of the federal inventory survey results and then this is the public input and then we have the minority response we did revise this sentence only for accuracy there is ogc would like us to add the additional verbiage of minority responses reflect the views of the individual authors and do not necessarily reflect the views of the working group or the u.s
department of health and human services if you all are in agreement this is the verbiage from ogc that this would be added after this sentence right here have an agreement do we have any opposition to this hearing none i think we can accept that as necessary to add okay great are there any questions for the message chapter okay then while we'll move on um if you are ready to chapter three chapter three was approved with editorial changes we have the background that starts at the bottom we had already made the changes to the figure so there's no update to that and then we go over to the next page that continues and comes over to the one health figure and approach the next page continues with that and then the figure on the next page with the life cycle and it continues and then talks about the maps and then the next page is about cdc and then the additional map for the historic and current expanded distribution and then we go into the major challenges and issues and then also to the recommendations that continue onto this page and go through here are there any questions with chapter three okay i don't hear any questions for chapter four are you ready to go there yes please for chapter four this was approved with editorial changes as well so we have the recommendations that are on this page and then the next page is the background and major challenges and issues next page is the table the table continues
2021-02-05