>> Welcome to the Tick-Borne Disease Working Group, meeting number 15 My name is Jennifer Gillissen and I’m from Kauffman and Associates and we’ll be the support for today I will now turn it over to Jim Berger >> Good morning On behalf of Kaye Hayes and myself, we’d like to welcome you to the 15th meeting of the Tick-Borne Disease Working Group and we’re calling the meeting to order With that, I will start out with a roll call Please announce yourself present once I read your name Dave Walker? >> Present >> Leigh Ann Soltysiak? >> Present >> Ben Beard? >> Present >> Scott Cooper? >> Present >> Scott Commins >> Present >> Angel Davey? >> Present >> Dennis Dixon? >> Sam Perdue is present >> Thank you, Donta >> Here >> Beto Perez De Leon? >> Present sir, I’m letting you know Present Beto present >> Thank you, Beto >> Todd Myers? >> I’m present >> Kevin Macaluso? Kevin Macaluso? >> Present >> Thank you, Kevin Moving on to Eugene Shapiro >> Present >> Pat Smith? >> Present >> Leith States? It is my understanding that Leith will be calling in later, 30 minutes late With that, we do have a quorum I turn that over to the Chairs Thank you >> This is Dave Walker I’d like to welcome my fellow Tick-Borne Disease Working Group members to our 15th meeting Counting today, I believe that we will have five occasions to meet before our work is done It kind of reminds me of my relatively short tasking track career I was not a great runner But I learned the importance of a strong finish And that is what we are going to do during these next five meetings And we’re going to produce the most effective report to Congress that we’re capable of I’d like to now turn things back over to Jim or to Leigh Ann if she has something to add >> No, very well said, David Thank you Looking forward to the strong finish and And we certainly are turning a corner So look forward to a good meeting today Thank you So let me go ahead and just recap the last meeting which was meeting number 14 During meeting number 14, we spent time reviewing content, discussing feedback and working to resolve comments in Chapters 3 through 7 Chapter 3 was Tick Biology, Ecology and Control, Chapter 4, Clinical Manifestation, Diagnosis and Diagnostics Chapter 5 was Causes, Pathogenesis and Pathophysiology Chapter 6 is Treatment And Chapter 7 Clinician and Public Education, Patient Access to Care review So for today, the agenda will be to begin with a review of the mission that Jim will kick off with the vision and values And then we’ll proceed with the public comments and an update from the public comment subcommittee And then we’ll move into Chapters 8, 9, 1 and 2 before completing with the table of contents and the title page review and then adjournment for today We’ll then go into day two, just for the agenda review today Day two will take place with the meeting on September 22nd Well, we’ll then proceed with the review, the update on Chapters 3, 4, 5, 6 and 7 Of course, we’ll come to an adjournment and a next step And then we’ll go to the next slide David? >> So well, today, we’re going to review, discuss and approve, vote for edits and comments

that have been made by the working group members for each chapter And I think this as an important opportunity for us to discuss things that are going to eventually come out in our report >> So just to look at this in terms of our overall timeline, you can see here pictorially, where we started in 2019 in January, how we’ve moved along with some significant timelines [inaudible] and then where we are today for September 15 As I acknowledged, we’ll have the part two of this meeting which is September 22nd, both of these, of course, being virtual meetings We will have the next meeting being meeting 16, October 27th And then we will have other meetings that will be announced with specific dates in November, as well as in — the final report to the HHS Secretary and Congress And it will be available on the Tick-Borne Disease website Yeah, go ahead Jim? >> Thank you Thank you, Leigh Ann With that, you know, our mission statement I’d like to share with you The Tick-Borne Disease Working Group’s 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 tick-borne diseases, to help ensure interagency coordination, and minimize overlap, and to examine research priorities As part of this mandate, and in order to provide expertise, we will ensure that the membership of the working group represents a diversity of scientific disciplines and views, and is comprised of both federal and non-federal representatives This includes patients, family members, or caregivers, advocates of non-profit in the interests 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 health and human services from the past, present, and the future Next slide, please We have one common purpose and that is a shared vision That vision is a nation free of tick-borne diseases, where new infections are prevented and patients have access to affordable care that restores health Next slide, please With that, I’d like to provide you our core values that consist of seven of them The first one is respect In other words, everyone is valued We respect all people treating them and their diverse experiences and perspectives with dignity, courtesy and openness And that’s only that those we encounter in this mission return the same favor to us Differing viewpoints are encouraged always, with the underlying assumptions that inclusivity and diversity of minority views will only strengthen and improve the quality of our collaborative effort in the long-term The next core value is innovation It’s shifting the paradigm finding a better way We strive to have an open-mind and think out of the box We keep what works and change what doesn’t We will transform outdated paradigm when necessary in order to improve the health and quality of life of every American The next core value is honesty and integrity Find the truth, tell the truth We are honest, civil and ethical in our conduct and interaction with our colleagues and collaborators We expect our people to be humble, but not reticent and to question the status quo whenever the data and the evidence support those questions Not to manipulate facts and data to a particular end or agenda and to acknowledge and speak the truth where we find it Our fourth core value is excellent quality, real world evidence underlined decision making We seek out rigorous evidence-based data driven and human centered insights and innovations 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 Quiet please The fifth core value is compassion, finding 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 goal is achieved The next core value is collaboration We work with citizens and patients as partners The best results and outcomes won’t be created behind closed doors, but will be co-created in the open 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 in 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 And the last but not least, core value that we have as a Tick-Borne Disease Working Group is accountability, in other words, the back [inaudible] here We as diligent stewards of the public trust, in the funds provided by our fellow citizens, pledge 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 Thank you Next slide, please >> Thank you, Jim It’s important to go through those values as it is important to readdress our objective, as defined by the 21st Century Cures Act This slide depicts a thorough review of the objective to provide expertise and review all efforts within HHS related to all tick-borne diseases to help ensure interagency coordination and minimize overlap and to examine research priorities Those duties include, not later than two years after the date of enactment of authorizing legislation, a review and summary of ongoing disease research, including research related to causes prevention, treatment, surveillance, diagnosis, diagnostics, duration of disease and intervention Also advances made pursuant to such research federal activities related to tick-borne diseases, including epidemiologic activities related to tick-borne diseases, basic clinical and translational tick-borne disease research related to pathogenesis, prevention, diagnosis and treatment of tick-borne diseases Gaps in tick-borne disease research described in clause B and working group meetings and comments received by the working group, and to make recommendations to the Secretary regarding any appropriate changes or improvements in such activities and research And importantly, 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 pathogens or organisms Next slide, please At this point, in our meeting, we’d like to welcome public comments We engage the public in several ways through verbal public comments at the meetings, through written public comments at the meetings available on the website, and through solicit — through the availability of emails to the tick-borne disease email at tickbornedisease@hhs.gov and that’s available 24/7 Today, we’d like to start with the first person who the operator will make available to us Operator, are you ready? If we’re on cue, we’d like to start with Carl Tedder [assumed spelling] Operator, are you available? >> Yes, I’m in >> OK, thank you So each speaker — We have 30 minutes set aside for the public speaking today We have 10 speakers and each speaker will have three minutes and then they’ll be cued just shortly before their time is up So we can introduce Carl Tedder >> Not connected >> I’m sorry, is he not connected you said? >> Not connected ma’am, yes >> OK. Let’s start with the next speaker please

Karen Duffy >> She’s on >> Thank you You may begin >> I’m here >> Thank you Go ahead >> OK. And you’re ready >> Yes, please go ahead Thank you >> OK. I want to thank you first of I wrote you as an advocate, and a survivor But now it’s winning Just a little of my story 55 years starting with what is now known as equine Lyme at age 17 Final bite Florida at age 35 sent me into chronic Lyme for 40 years just because my chronic Lyme was drastically misdiagnosed It was buried in my records for 10 years I found it And then once they saw it, they ignored it Even though I had the positive Lyme blood tests across the board, it was continually ignored Why? My chronic Lyme now has gone into severe coinfections, it’s probably too late for me, but maybe this will help others In the last eight months, I’ve been in and out of the hospital only too soon be dismissed because I’m a medical hot potato and a political hot potato They don’t want to get involved They just look away and just send me home still severely ill Why? I’ve tried numerous remedies, it doesn’t work You wouldn’t even have the time to hear all the crazy stuff I’ve tried I’ve lost my identity as I knew it I lost my family, friends, social life, income, medical community, continually thinking that we’re crazy or lying Why? Most of us were looking at athletes, successful people, moms, dads, the mom, we don’t even want to go to doctors anymore It’s a waste of time and money and no insurance coverage Why? Not to mention the abuse that we get from the medical system I have been diagnosed with serious diagnosis now such as Lyme dysautonomia, which is — and also familiar — which is fatal The mast cell I’ve been going in anaphylactic shock, fatal Trigeminal neuralgia, just in one night, just put yourself in this position violent chills, extreme sweats, stabbing and stinging pain Such painful each, you can’t even get — vision, lost hearing, vibrating, restless legs, burning, overwhelming histamine, nausea, anaphylactic spinal disorder, BP 220/112 or 60/40, dry heaves, passing out, knocking myself out, knocking teeth out, constant pain due to the biofilm protection medical tests coming back negative All the severe co infections are still there and being ignored by the government insurance companies We’re a revolving doors, our bodies are dying They treat the symptoms, but not the pain Just imagine this cost Now for the symptoms ask Dr. Spector, who — or seven of my Lyme friends, oh, wait a minute, you can’t they’re all dead But we don’t die of this or how much of the 10 Alzheimer’s patients that donated brains and seven out of the 10 had Lyme disease They thought that was very peculiar Why wasn’t that researched further? All I can say it’s a very people that I love and hated as I told you — or loved throughout my life has let me down Why? People think I’m near to my deathbed I’ve lost 36 pounds and still not trying It didn’t need to be Can someone help us? >> Thank you Operator, Lucy Barnes >> Thank you Good morning As you know, a huge number of scientific papers have already been presented here there and everywhere That clearly indicates chronic Lyme disease exists and is destroying countless lives Yet, billions of dollars and four decades later, count them one, two, three, four decades after its discovery, accurate tests necessary to detect or — early or chronic Lyme and the treatment that’s necessary [Inaudible] has to say the least not been forthcoming The IDSA, CDC, HHS and NIH has failed us all And rather than this panel focusing on and utilizing the science and clinical data that would allow us to move forward Some members, who are violating the Tick-borne Disease Working Group’s core values, just continue to manipulate or omit the facts, while funneling more and more of the funding

to unreliable, private and government agencies in order to support the failed status quo Panel members, we are fighting for our lives and the lives of so many more innocent people And nothing we presented today seems to have made a dent in the “no such thing as chronic Lyme disease” mantra that you’ve been clinging to and hold so dear Panel members, how many families will separate under the stress of a chronic illness that goes unchecked or lose their homes, or lose their job or lose their dignity because you didn’t take a stand to help them when you had the chance? People watching these meetings know that you know better Stop trying to sell us and Congress the same old failed junk science and theories that have been and still are literally killing us We need you to get the truth about chronic Lyme disease into this report and all future reports Panel members, if you are willing to get the facts and details concerning chronic Lyme disease into this report, and give it the honest and sincere attention it deserves, please say so Thank you >> Thank you, operator, Philip Sewell Cornell Spinner [assumed spelling] >> Yes. Can you hear me? >> Yes, please go ahead Thank you >> Right. Well, first of all, I’d like to thank you for allowing me this time to address the board I’m very excited We’re applied several times to do it And one time, I was not able to attend because I became ill And I would — Ideally, we’d like to be there in person to see you all and in person and express my support for what you’re doing I thank you very much for all of your efforts You’re quite an impressive group of people And no doubt you all have influence And we as — I’m here as private citizen, I’m representing my children, and myself We all contracted tick-borne diseases, illnesses It showed up in me first in the most drastic I contracted it in the year 2002 and I was only diagnosed in 2016 I drove myself to the emergency room and with what I thought was meningitis, because I have had that before And I was turned away, because they thought I was there for drugs, painkillers or something I don’t know But anyway, I left there empty handed and drove myself back home I am alone I have alienated my — well my wife left me she — we’re divorced And she took our four children with her And that was 10 years ago And I have successfully alienated all of my friends and my siblings The only person that had any compassion was my mother And she’s an elderly woman at this point And God bless her for doing that I could go on and tell you all horror stories about what I’ve been through over the year I lived with leg pain for seven years And I’ve had moments of paralysis of my legs one day, and then my hands another day

And it’s just been a strange The whole of it has been strange And I have good days and bad days The — I have sought treatment I have worn out my welcome in many different physicians’ offices And the first thing I asked when I see a physician, are you familiar with Lyme disease, tick-borne illnesses? Oh, yes. And I say great so this is what I would like to do, I’d like to try this and this And it — Every physician that I’ve seen either will not test me for 10 years They — No one would test me for a tick-borne illness And after my trip to the emergency room, three days later, I went to see a local small office And it was really my last hope and this is where I am now And she said to me, have you ever been tested for tick-borne illnesses? And I said, no, and no one will test me Well, they did a blood test And 10 days later, they called me and said, we need to see you immediately And I thought, OK, well, what’s the big emergency but I’m on my way And the first thing they found was Rocky Mountain spotted fever And I did not test positive for any other illnesses at that time And that’s because the testing is so poor, as everybody knows And I started — She started me on a regimen of doxycycline and boy it hit me hard and I was laid up in bed for a week, for a month, she — we did a full week treatment And then I would take two weeks off and then the second month, she added a second drug Flagyl and that was to crack biofilm and expose the parasite and then the doxycycline would kill it And then it would explode in my head, you know, with the heartsink reactions And I was laid up for five months bedridden A lot of them was drink bottles of water and eat crackers I haven’t had an appetite in over 10 years And that doesn’t seem to bother many people at all I started off with I had a noticeable weight gain that I didn’t earn And — So I have it checked out, it turns out that I had — I was covered in hundreds of swollen lymph nodes and to the weight of 70 pounds, I was carrying around 70 pounds of fluid And the — I have set up into many different positions and many different cities and several states trying to find out what was wrong with me And I was thrilled to find out that there was something actually wrong >> Excuse me, Mr. Sewell Cornell We are very grateful for your story And thank you so much for sharing with all of us today I’m so sorry There was a problem with the timer and it looks like your past your three minutes, in fairness to all the others At this time, we’re going to have to ask you to conclude >> May I say may I — I will — I would like to conclude with my only suggestion that I have is as a patients, you know, I’ve become somewhat of an idiot

I have a lot — I used to be a smart guy I used to run two companies work for myself and made a living And now I can barely do math Perhaps, if you all would consider suggesting a liaison group that would help work with patients seeking care, because I’m not capable of finding another physician They’re just not — >> We would welcome that suggestion Would you be able to follow up with that in the email, perhaps putting those details in the email and then that can be reviewed Thank you so much again for your time today >> Well, thank you >> Operator would like — Thank you so much >> Thank you so much >> Thank you Operator we’d like to proceed with Preston Wiles [assumed spelling] >> Preston Wiles is not connected, but we already have Carl Tuttle [assumed spelling] on the line >> Please go ahead Carl Tuttle >> I’m from New Hampshire This comment is directed to Dr. Eugene Shapiro Dr. Shapiro, I sent you an email on September 2nd with a list of references identifying persistent Lyme disease after extensive antibiotic treatment As I mentioned in the letter, an astute fifth grader with access to PubMed could find those references and many, many more What I didn’t share with you is a 1991 positive culture report I have from the Centers for Disease Control in Fort Collins, Colorado, where the CDC cultured the spirochete from the cerebral spinal fluid of Dr Kenneth Liegner’s patient Vicki Logan, despite prior treatment with intravenous antibiotics Her autopsy report shows histopathologic findings consistent with neurologic manifestations of chronic Lyme disease Lyme patient Vicki Logan died after the insurer refused additional IV antibiotics This is medical execution Dr. Shapiro, you neglected to answer my question, which was, could you please explain your motivation for suppressing evidence of persistent infection after extensive antibiotic treatment, and then claiming there is no evidence? The following comment is directed to Pat Smith, patient representative This denial has led to the disease being misclassified as a low risk and non-urgent health threat when in fact, we have been dealing with an antibiotic resistance slash tolerant superbug and patient testimony all across America is describing a disease like you just heard, that is ruining lives, ending careers while leaving its victim in a financial — a chronic relapsing seronegative disease, as you know, should have set off a red flag But it’s misclassification as a simple nuisance disease has left hundreds of thousands if not millions worldwide in a debilitated state I respectfully ask that you hold Dr Shapiro’s feet to the fire and demand an answer to my question before proceeding with today’s agenda A copy of Vicki Logan’s positive cultural report and autopsy results will be sent to the members of the Tick-Borne Disease Working Group immediately following this comment Thank you for your time, Carl Tuttle Hudson, New Hampshire >> Thank you Do we have Preston Wiles back on the line? OK. Operator, are we ready for — >> Preston is not on >> OK, are we ready for Erin Walker? >> Erin please, go ahead >> Yes. Can you hear me? >> Yes, we can Thank you Please go ahead >> All right Thank you I’m a little emotional after Carl Tuttle’s talk So I am Erin Walker I am the wife of PGA Tour winner Jimmy Walker I’m also on the board of directors at the Global Limelight In 2017, after months of battling what my husband thought was the flu, my sixth time PGA tour winning and major champion husband Jimmy Walker tested positive for Lyme Living in Texas had it not been for a sports psychologist we never ever would have been tested for Lyme After extensive blood work, he was positive for Lyme, West Nile, mono, two different types

of bacterial pneumonia virus called CMV All these illnesses were active in his system at one time In 18 months of treatment, and yet today, that was three years ago, he still battles exhaustion, depression and flu like symptoms The disease has wreaked havoc on his career, and due to the neurological effects of Lyme, we aren’t sure he can continue to play high level competitive golf anymore I myself was diagnosed with Lyme in late 2017 after experiencing a completely different set of symptoms as my husband I completed a nine month pulsed course of antibiotics Although mild, I still have days where I experienced symptoms of Lyme Well, Jimmy and I consider ourselves lucky because we were diagnosed correctly and were able to live active normal lives, which is certainly not the case for many Lyme suffers living in this country While the designation is important, accurate testing as a foundation, doctors must recognize that Lyme can present with over a hundred different symptoms If given access to more accurate testing, thousands of patients may be able to avoid the prolonged effects of this awful disease, regardless of a chronic or post-treatment Lyme disease designation by this group People are sick and they deserve better, or seeking access to accurate testing, insurance coverage for this disease Employers recognizing that this is real, the stigma, the doctor ignorance, and the public shaming that surrounds this disease needs to be rectified We are a small household of four from South Texas and now three out of the four of us have tested positive for a tick-borne disease, three out of four in a state where they don’t think they have tick-borne diseases My husband and I for Lyme, and most recently, our seven-year-old son for Babesia, none of us saw a tick or a bite Only our son had a small rash that his pediatrician refused to treat three years ago People in this community will not stop fighting until we get better, better testing, better treatment, better recognition for the fact that Lyme is real It’s a real disease that affects real Americans Thank you for your time and attention to my comments >> Thank you, Marlena Coelho [assumed spelling] >> Please go ahead Marlena >> Hello, can you hear me? >> Yes, thank you Please proceed >> Hello, my name is Marlena Coelho Today, I would like to present my own personal story with Lyme disease and its crushing co-infection and also bring light to the intertwining of government and private interests that is that part of the American health system for decades In the fall of 2015, when I was in the prime of my life, I was completely bedridden by a mysterious illness I was experiencing muscle weakness, listlessness, memory loss and crushing fatigue The several doctors I initially saw could not find anything wrong with me And when my blood work came back normal, they mentioned seeing a psychiatrist I had to quit my job and move in with my parents Over the next nine months, I saw 25 doctors from prestigious hospitals all over the State of California, but not one could diagnose me with anything besides depression I finally received a positive test of Lyme disease and babesiosis and began treatment right away Now, four years later, I can tell you that I still struggle with some issues But I’m much better than I was before and I’m almost completely healed I’m sure you’ve heard several stories that have sounded just like mine I know one doctor on this panel who has helped revoke the license of pediatrician, Dr. Charles Ray Jones, who healed thousands of children from chronic Lyme disease Why is science being ignored? And why is the scientific method not being applied? Well, it’s because conflicts of interest are rampant in the medical community at the very government agencies that are supposed to be protecting the public interest, not the interest of individuals or mega corporations Lyme disease is just one example of this But I suppose this is why you’re all here now to perhaps undo the wrongs that have been done to so many by those who have the power to shape public policies and guidelines for their own benefit Or is it just for show? When this committee formed, I was filled with hope that at the possibility that our broken medical system could change My illness would finally be recognized and covered by insurance, and our doctors would not have to be persecuted for treating their patients with the correct protocols However, my hopes were snuffed out as soon as they learned that Dr. Eugene Shapiro was appointed to the working group Shapiro has helped insurance companies deny disability benefits and insurance coverage

to Lyme patients and were paid large sums of money in consulting fees for his efforts He was defendant in Torrey vs IDSA et al, the federal law suit that charged the guidelines authors and eight insurance companies with conspiring to deny medical care to Lyme disease patients I am one of the 38,000 signatures on the petition to remove him from this group which has been ignored The purpose of the working group is to advance the interests of patients with chronic Lyme disease, and to include their voices in the discussion of what research prioritize The fact that you appointed someone with such biases and financial conflicts of interest is a slap in the face to all of us that you’re supposedly seeking to protect Once again, financial interest and greed comes before the American people and sadly I am not surprised The right to life, liberty and the pursuit of happiness has become synonymous with do no harm They are meaningless, empty words to those who suffer under broken systems that put greed before people Thank you >> Thank you Julian Gordon? >> My name is Julian Gordon I’m a clinical social worker in the state of New York, a graduate of Columbia University in ’98 and in private practice in the Hudson Valley I’m also a mother My adult son had tick attachments in 2013 and ’14, while living in Castro State Park in upstate New York This tick-borne disease was minimally treated after three admissions to a local hospital Persistent symptoms were ignored and denied allowing the disease to spread and become more serious As behavioral symptoms became more consistent with neurological Lyme disease, my son was stigmatized and again denied informed evaluation and treatment for Lyme disease He is currently confined in a New York State Psychiatric facility His blood tests revealing 15 bands positive for Lyme disease were ignored by the local hospital in 2014 and again by the State of New York in 2016 He has been denied treatment for Lyme disease to the present day My son is like millions of others in this country, his health ravaged because of an antiquated and unsupportable, 40-year old construct that did not accurately represent the complexities of Lyme disease in the 1970s and still has not been updated or expanded to reflect new science But he is much worse off His Lyme disease and associated tick-borne diseases have advanced like wildfire, and he will die in the New York State Mental Health system, unless somebody has the courage to help us My son who is diagnosed with Lyme disease was denied treatment because of the CDCs refusal to acknowledge the Lyme disease treatment guidelines of the International Lyme and Associated Diseases Society The ILADS guidelines meet every requirement of the Department of Health and Human Services for treatment guidelines Yet the CDC has failed to recognize these current pure in practice guidelines, the CDC only recognizes the 40-year old antiquated and highly biased guidelines of the Infectious Disease Society of America The IDSA guidelines are the ones the medical establishment has followed, deny treatment to my son I am unable to pursue this matter legally because HHS and CDC stick to this erroneous 40-year old IDSA sanctified definition of Lyme disease and ignore research The legal system relies upon this flawed definition to make fair and informed judgments, leaving people like my son and I without legal protection against the current and medical malfeasance that we’ve been living for the past — living with for the past six years What corrupt manipulation is this? None of us being abused by the flawed IDSA guidelines can seek any legal relief whatsoever So we get sicker and sicker and sicker, and that would even be somewhat tolerable If my son were simply at liberty, he can’t even be treated in a state facility But he’s in a psychiatric hospital being denied treatment and liberty My son will die of advanced untreated neurological Lyme disease because of arrogance and ignorance, professional greed and politics I’m here to ask for help I want the people in this room involved with the CDCs position on Lyme diseases to step up, put the ILADS guidelines up on the CDC website as authorized guidelines and authorized treatment protocols before it is too late for my son and others The ILADS guidelines reflect the current science, the IDSA guidelines do not The ILADS guidelines meet and surpass every standard HHS requires for guidelines Why are they not on posted on the CDC website to help medical providers and people like my son? Put the ILADS guidelines up on the CDC website,

before my son loses his life to this ridiculousness Then please assign somebody in the CDC or HHS to investigate my son’s case We need somebody to talk with the institution that is holding my son in the Office of Mental Health exactly to treat him in accordance with the ILADS guideline as per yours and my wishes I cannot see how any of this is productive You’re welcome >> Thank you Elizabeth Bonnet >> OK. Good morning I’m calling in from Central North Carolina in collaboration with Tick Lyme Conditions United and thank you for this opportunity to share my recent experience with tick-borne illness Improvements are needed and continued training for physicians for one of the most rapidly deadly, tick-borne illnesses, Rocky Mountain spotted fever I am an example of how even in a highly educated and medically savvy community diagnosing and treating tick-borne illness is not effectively occurring This spring, I sustained six brief tick bites over the course of 10 weeks When becoming ill, I went to my primary care with my sixth ticks taped to post it notes and asked for doxycycline as I suspected a tick-borne illness He said he needed blood work first ran a CMP, at CBC wrote in my chart that it was most likely anxiety and reported back that all the labs looked good Meanwhile, I was feeling worse now bedridden, and I’ve returned to the primary care begging for an exhaustive search for infection with more labs My certified nurse midwife was exact — was aghast that I had had six tick bites, and wasn’t put on doxycycline immediately So she prescribed it, thereby saving my life Two and a half weeks after I had originally sought treatment for tick-borne illness at the primary cares office, they called to tell me that I had a very high Rocky Mountain spotted fever titer, 1 to 256 And I should go pick up some doxycycline If I had waited for this lab diagnosis or my CNM was not willing to bridge this medical care failure, I might not be sharing this testimony with you today How did my RMSF diagnosis get so botched? I never had any of the common symptoms indicating RMSF My only two symptoms were severe malaise and loss of appetite, resulting in a 10 pound weight loss before the ordeal was over Physicians need to know that a patient does not have to have a fever or a rash to be suffering from RMSF Physicians need continuing education that treatment should not be withheld pending lab confirmation in the case of tick-borne illnesses The primary care only prescribed 10 days of doxy and was completely baffled that I did not bounce back to health within that timeframe It can take antibiotics more than three times as long as the currently posted recommendations lead one to believe RMSF is too dangerous and to easily treatable a tick-borne illness to have such diagnosis and treatment misses Websites and physicians need updating with more current RMSF information including one, awareness that RMSF can present without any fever or rash Two, reminders not to delay treatment pending lab results when tick-borne illness is suspected And three, it is not uncommon for RMSF to need more than one round of doxycycline for recovery I asked this working group to please give more attention to tick-borne illnesses most prevalent in the south I am evidence that preventable misdiagnosis are still happening here Thank you so much Elizabeth Bonnet, North Carolina >> Thank you Carmen Payne >> Hi, this is Carmen Can you hear me? >> Yes, please proceed >> Hi. My name is Carmen Payne I’m an educational Ambassador with the Global Lyme Alliance and a Lyme warrior I have been battling Lyme disease plus coinfections for 27 years I have experienced paralysis, tremors, loss of vision which has left me with permanent retinal damage, and suffered cognitive impairment, debilitating pain and migraines For years searching for an answer on what was happening to my body was like walking through a house of mirrors and encountering dead ends at every turn with no way out The lack of knowledge in the medical community on tick-borne illness is beyond astounding For 26 years I had been told repeatedly that Lyme did not exist in California One doctor even asked me when did you go to Lyme, Connecticut After testing multiple times with a CDC positive results, I was told repeatedly that it was a false positive In addition it took me 27 years for me to find out that I also have babesia,

tick-borne relapsing fever and for bartonella I know my experience is the same story that hundreds and thousands of other people who suffer tick-borne illness have experienced, and some have even lost their battle We are humiliated, ridiculed, labeled and turned away from receiving help we so desperately need One of the things that I would like for the group to address is educating the medical community starting with medical schools I feel this is a critical step in helping patients regardless of what occurs from the report that you will deliver If the medical community is not educated on tick-borne illness, they will continue to miss the signs and misdiagnose patients, potentially for decades, causing irreversible damage As you’re aware tick-borne disease is a multi-systemic disease and can affect every organ, muscle joint, heart, even your brain This is not an infectious disease specialty This is an all doctors specialty All doctors must be trained on tick-borne illness, and how they can affect patients and what to look for in order to be able to diagnose, OB-GYN, GI, neurology, rheumatology, orthopedic, psychiatry, the list goes on All specialties should be required to complete continuing education units in tick-borne illness, so that they can understand how tick-borne infections can impact their area of specialty, and how to treat it Tick-borne illnesses have been politicized and, excuse me, and patients have been marginalized in the medical community for more than 40 years now This has to stop And this group has the opportunity to change that I will end with this quote The time is always right to do the right thing, Martin Luther King Thank you for your time >> I’d like to thank everyone for preparing your comments today On behalf of my additional co-chair, and also all the Tick-Borne Disease Working Group Members, I want to just make a statement that I take personal responsibility for having some difficulty hearing the time today indicating the timer I apologize for that, again, emphasizing that it was my personal technical challenge and that presented some problems today If you did not feel you had the opportunity to articulate all of the comments you’d like to make, please make sure you follow up by emailing those comments to the tickbornedisease@hhs.gov email Thank you very much again Next slide please David? >> So our next agenda item is the public comments subcommittee update The co-chairs of this committee are Scott Commins, Angel Davey and Leigh Ann Soltysiak And the report is going to be given by Angel Davey, Angel? >> All right Thank you, David And good morning to everyone I think we need to begin with the first slide, if you will, please So as we open this meeting with hearing comments from the public, we’ll follow now with this update of the public comments subcommittee I think we are missing our disclaimer slide Could you go to that, please? Yes, thank you So in the interest of time, I’m going to quickly move through the next several slides just to be sure that we do capture the material in the transcript of our slides And this slide that’s shown right now is our standard disclaimer Next slide, please So slide — this slide three for me on my slide set has also been shown in prior meetings So the public comment subcommittee is designed to review public comments and to share the findings of our review with the group to help enhance their awareness of the identified issues, priorities, concepts, references, and resources that are important to the public at large Next slide So we’ve seen this slide previously as well The public comments subcommittee systematically reviewed comments provided by the public starting back in January of 2019 up through July of 2020, and that includes comments submitted via the working group email address as well as delivered verbally by patients and other concerned stakeholders at our public meetings Next slide This is a bit redundant As David already said subcommittee members are Dr. Scott Commins, Leigh Ann Soltysiak, and myself I did want to take the opportunity here to let the patient community know

that this subcommittee has read every single one of your comments And we understand that this working group was established because of Lyme disease advocates and in particular, those who are advocating for the acknowledgement of an improved care for those with chronic tick-borne conditions Yes, next slide is already there So here we continue to add on to our summary of key themes from the public comments submitted each month I know this is virtually impossible to read But shown here are comments from January through March, these have been covered previously We’re just capturing them here again for the record Moving to the next slide, please Since our virtual working group meeting back in April, here on this slide and on the next, we’ve now added key themes summarize from public comments submitted in April, May and June of 2020 Next slide, please I’m going to talk about some of these in more detail in a few moments So again, here, this is a continuation of June themes captured as well as those received in July Next slide, please OK. So now, what I’d like to do is to highlight some key themes or priority areas from months of April, May, and June 1 So this is material that should have been covered back in our July 8th meeting presentation, but we were unable to get to it, because we ran out of time So for April highlights include the public’s concern that CDC guidelines for Lyme and tick-borne disease management create challenges and obstacles to patient care and reimbursement We also again hear a call for improved diagnostics and earlier treatment of Lyme disease before longer term disability may occur Next slide For May on slide 10 here, I’ll just highlight here a call for increased awareness about chronic or persistent Lyme disease, as well as the need for increased recognition of Chronic Rocky Mountain spotted fever Next slide Here for the month of June, we reviewed a record 58 emails from patients and advocates that were largely focused on bringing persistent or chronic Lyme disease to the attention of the working group Those comments that were submitted from patients in June, they ranged from those who are just a few years post tick-bite to those who were bitten more than 25 years ago Some of the submissions were pages long So it really seems to be a disservice to digest these patient stories into just a bullet point or two But given the volume of information received in the form that we have for presentation, this is kind of how the information can best be shared during our meetings But again, just know that your comments are being seen So here speaking of this slide, a major recurring theme that we continue to read is that denying the existence of persistent or chronic Lyme disease is an injustice to patients who’ve been living with the effects of the disease for years Patients are continuing to go undiagnosed and untreated We continue to see a call for better Lyme disease awareness and education of health care providers, which includes empowering them to feel comfortable to make a diagnosis without fear that their reputations or careers are going to be negatively impacted Next slide please Another recurring theme cited by the public as again poor access to care and tied to this is inadequate or nonexistent reimbursement which hinders treatment in an environment where, you know, the patient feel that effective treatment options are really limited All of these issues together have been cited by individuals submitting comments as leading to depression and suicidality in patients with chronic conditions Next slide We’ve heard it before but we saw it again in the June comments that patients are finding that current diagnostic testing and treatment guidelines are inaccurate and they are calling for amending the treatment guidelines for persistent for chronic Lyme diseases as we just heard in our comment session prior to this Next slide So also in June, the public provided a call for Lyme disease research funding for improving diagnostics and treatments on the level that we see with other chronic diseases such as cancer, and also calling for research funding for determining what underlies the persistence of Lyme disease, infection and/or symptoms One particular patient provided a detailed story of going back and forth for years between experiencing symptoms and testing positive for Lyme disease receiving treatment until, you know, finally testing negative and then having to repeat that cycle as symptoms and positive test results would continue to return So this patient’s course of treatment was hampered by the guidelines, you know, driving the insurance coverage Next slide please So many of the patients submitting comments in June cited a number of persistent

or chronic Lyme disease symptoms, as shown here on the slide And they noted that misdiagnosis of their condition was rampant And it really spans a wide range of diseases as you can see here Moving very quickly here So next slide Also in June, the issue of transpersonal transmission of borrelia burgdorferi was again raised along with the question pertaining to borrelia transmission via breast milk Concerns were again expressed over development of a vaccine without a reliable way to diagnostically prove prevention or cure Next slide So here, coming to some of the comments from July, we heard from numerous patients addressing a number of recurrent themes And it’s noted on the slide that’s up right now, their stories further demonstrated poor access to care, again, an inadequate or nonexistent reimbursement, which hinders effective treatment Next slide Here, again, another recurrent theme we heard from patients whose experiences demonstrate that Lyme disease is still minimized or denied by healthcare providers, and they’re really calling for desperate — a desperate need for improved awareness and education of health care providers OK. So here is shown on the current slide in July, there were three studies that were brought to the attention of the public comments subcommittee, including one outlining problems with diagnosing and treating chronic Lyme disease or PTLDs, one that’s supported the existence of chronic Lyme or PTLDs and another demonstrating persistence of borrelia burgdorferi, antigens and DNA in a Lyme disease patient So we often received references like this And then moving on finally to — this is the last slide So, really, month after month, we continued to read through many heart wrenching stories about how patients with chronic Lyme disease and other tick-borne diseases are being failed by our healthcare system And through their public comments, the patients really continue to cry out to this working group for help And they’re describing their suffering from a range of symptoms that, you know, can often include debilitating pain, their lives, as we’ve heard, have been completely disrupted in every way imaginable And really, as a collective group, these patients are demanding to be heard, calling for awareness and recognition of their tick-borne conditions, regardless of where, where they live, and most importantly, desperately seeking appropriate, effective and affordable treatment options So that’s all thank you for your attention >> OK. So we are going to begin with Chapter 8, Epidemiology and Surveillance And we are going to ask that the lead to the chapter help to walk through the comments So we just saw the slide that indicated the lead for this chapter And I’d like to ask if those leads would like to go ahead and move forward with the chapter comments One by one, we’re going to be going forward through the chapter comments And the facilitators, myself, and David will also help to make sure that we’re addressing those comments and helping to facilitate the intake So we will start with, with Ben Beard and Gene Shapiro >> All right Gene, I don’t know how you’d like to do this We can just both chime in along the way or just whatever But I do want to make a comment You know, I’m confused because on this chapter as it occurs in SharePoint is not the one that I originally submitted And I submitted a chapter on — I’m looking at the email on May 8th, and Jennifer actually sent this round to the whole group and it was this is, you know, the draft of Chapter 8 And I replied all in copy with the big tables and figures And the reason I mention is because the references to the tables and figures got cut out somewhere along the way, and I suppose someone was editing this and maybe failed to use the track changes feature And so there were large parts of this that were cut out as a background or several statements at least, key statements

And those statements included the references to the tables and figures And also under recommendation 83, that was where tables 2a or figures 2a and 2b were referenced So if you look at this right now, you’ve got a table and figure file But nowhere in the document are those referenced because those were removed Maybe someone was editing and thought it was better included in a background section But I never saw where it got included So right now the tables and figures are kind of irrelevant So I don’t know if anyone wants to comment on process But I suppose it was because the track changes wasn’t used and these were just cut out by someone >> So are one thing, Jennifer, we’re seeing some comments about pulling up this into a larger text, if that’s possible, like we did last time And then are we able to jump back to the tables and figures by just pulling up those as different separate documents just to — yes, we’re able to do that Ben and Gene >> Right. And they’re on the screen right now But figure 1 and table 1 were referenced in the first paragraph are the original background in Chapter 8 And then figure — The last two which are labeled figure 2a figure 2b, these were referenced under the text and recommendation 8.3 And those statements, as I mentioned, got removed without being done using track changes >> So I guess, proceed with the table that as a wish that we can certainly address those in the background, but they need to — they need to be approved and commented on So I’ll leave that up to you >> Well, I can walk you through these All these are just basic, you know, they’re not critical to the — they are the official numbers on trans and burden and things like that, the reporting based on the reported cases And I can walk through figure one here is just showing from 2004 to 2018 And it shows the numbers of reported tick-borne disease cases for the reportable tick-borne diseases And then it also shows a single line with the trends And also I think I explained under reporting in 2018, you know, as a cause for the dip there in one of the challenges But if you move on to table 2 — on table 1 rather, the next, this again, are just the official numbers of reported cases over those years and cumulative from 2004 to 2018 And then finally or and then if you go to the next two, this figure is reporting — showing the reported human cases of Lyme disease It shows a high and low incidence states as defined And this is also discussed in, you know, further in the report And then the last figure is really just showing how that tracks with the distribution of Ixodes pacificus and Ixodes scapularis And these, again, are numbers of — from the National Tick Surveillance Program that were stood up following the recommendations of the last report So I’ll say this, none of these are critical to the report They just help substantiate statements that are made And if they did cut out, I’m fine with that right now They’re not referenced at all in this chapter, because the statements they supported have been removed >> So Ben this is David Walker I believe that these are very appropriate to have in this chapter and to not know the procedure by which they were removed and proposed that they should not be removed in this chapter The other question is whether they belong in the background section, the general background >> Well, this is — this section is epidemiology so that’s what this is about and surveillance >> Yeah. So I mean, I think, you know, in the background chapters, I could — there could be a sentence put in saying, you know, information about epidemiology and surveillance is in Chapter 8, because that would be appropriate >> Yeah, I — >> We’re going to get to the background chapter later, but I think it’s more background to the — if there’s going to be a report and how it came about >> Right >> And this — It’s not a background to provide lots of facts

and information about the diseases We could address that when we get to that chapter But I think, at this point these — this is epidemiology and surveillance and does belong in this chapter >> Yeah, I can record that as well >> Yeah, I guess the statement is what about or I guess the problem is what to do with the statements that were supported because they were removed And they’re not showing in the document that we’re looking at But like I said, if you go back to May 8, 2020, you’ll look at Jennifer Gillissen’s email to the whole group and says, good afternoon attached is Chapter 8 for review It’s been uploaded into SharePoint And if you cross compare that document with what’s in SharePoint, you’ll see what was cut out And it was just unfortunate that it wasn’t — track changes wasn’t used >> So Ben, if this may amount of what three sentences have been cut out? >> Yeah, yeah, just a few sentences, not a whole lot >> Why don’t you read the three sentences and where they go, and let’s discuss them Because I think this is an inadvertent, I don’t have any knowledge of how and why that would have happened And it does not sound appropriate to me >> Well, I think it was just process We were all using SharePoint and not really sure exactly how to use it And I think probably someone just said, well, this probably is better suited in the background, and they just cut it out >> This is Pat I would like to make a comment First of all, I’d like to say that my power went out And so I lost my — I’m not online at the moment My computer is still coming up And I heard the beginning of this discussion And — But it’s very — I can’t get online yet But it’s very disturbing to me, because I made a comment in your section Ben that indicated that this was not the same — I said this does not appear to be the same report, as originally submitted, because I had already downloaded that report And it was different And so the comments that came back from Jennifer Gillissen was it’s the exact same one Well, it wasn’t the exact same one And this is very disturbing to me now for you saying at this point, you know, weeks and months later that this indeed is not the correct one, because I have the original one in front of me that I printed out because I had it And that one has another opening paragraph under the background section, which is totally different than the opening paragraphs that you have in on the current version So this is disturbing to me from the perspective of the fact that I was told that at that point, and my comment was addressed and said that this was the same version when it isn’t the same version >> Well, and I think if that’s true, I think, like I said, I can surmise probably what happened is that one of us were editing it And we just didn’t know to use track changes And so someone probably read it says, well, this probably fits better somewhere else And it got cut out And therefore what Jennifer saying was correct It was the same version but it got edited after it got posted on SharePoint and once and it didn’t use track changes >> Yeah >> Ben. Can I say something? This is Angel, this — my comment doesn’t have to do with version control But refers to the figure that you have up on the screen right now figure 2b >> Yeah >> Not disease surveillance, but this is tick surveillance And if you look, I know we’re not going to get to it until September 22nd But I believe that this figure is supposed to appear in Chapter 3, the tick biology and ecology chapter Maybe Kevin or Beto could speak to that So I don’t think — >> Can I speak to that actually No, this is my figure and it’s from our presentation CDC data And we included it I included it here, because it was sort of — one of the recommendations of the last report was this — about the short falling, the shortcomings of Human Disease Surveillance, and the recommendation that one of the ways to address that is by enacting National Tick Surveillance so that we can better define the areas of risk where people are living

as the risk for Lyme disease expands Now, but to your point Angel, it could easily be moved to the vector chapter, just as long as that’s — as long as that is explained But in this case, you know, there’s tick surveillance and human surveillance And they’re not done as separate disciplines We view them as one It’s there to advise the other, but that’s the reason So it was originally in this chapter, and I submitted that figure But your — To your point is, it could be moved if we wanted to do that as a group >> Yeah. OK >> This is Beto — >> Yeah >> Yeah, go ahead >> No, I was just going to say it looks like it’s in the current Chapter 3 draft, but we’re not speaking about that chapter right now So go ahead Beto >> Oh, it has been moved OK. Sorry, that escaped me >> But that’s a good point And I think we discussed that before Ben, where you were going to help us to update one of the figures in this I think this is it And we — I think we can work out where if we can indeed be in Chapter 3, of course You can refer to it in your chapter because it appears later But, yeah, this is combined work And I think that will help in that way, yeah >> OK. That’s a good idea >> Thank you And thank you, Angel >> Nevertheless, I believe that the first three figures really — we’re taken out of this chapter belong in there >> Yeah, Ben if you can try to gather some consensus on that, because I fully support the inclusion of any visuals throughout the report I think it adds great value >> So yes, I’m here This is Beto Ben, and of course, the rest of the group, but would it be possible to have a richer version of the figure later on in your chapter, Chapter 8, Ben and Gene? Where you superimpose the tick data with the human case data to get a better picture that way in the context of epidemiology and surveillance for the disease? Because in Chapter 3, we will be talking about tick surveillance, right? But for Chapter 8, could we then put that layer of the human cases, especially for Lyme disease, in that context to then get a fuller picture of what’s going on? >> You know, I think probably is best just to put leave this in Chapter 3 And then just mentioned the way why do we do tick surveillance? What is the benefit of this? And how does it help fill out the story of where risk occurs for human illness? And I think you’ve done that well, in your chapter So, you know, I think we just — I think that those statements were omitted from the current version of Chapter 8 So it may be fine, just to leave it the way it is for that And then to add some text back in to the beginning of Chapter 8 that introduces figures, 1, 2 or figure 1 and table 2 >> OK. All right Thank you >> I agree with that I think that those are the true CDC data coming from the CDC And that they are very important surveillance and should be in this report That is a figure 1 and table 1 >> It’s a single paragraph and it’s kind of dry, but I, you know, to the request earlier, I think that I’d be glad to read it to you to see if people, you know, with or I can email it to you, but — >> I’m going — read it to us, Ben >> OK. The number of tick-borne diseases reported each year has been increasing steadily over the last two decades, figure 1 in parenthesis Tick-borne diseases currently account for almost 80% of all nationally notifiable vector borne diseases reported to CDC each year, table 1 In 2017, 59,349 cases of tick-borne diseases were reported to CDC, a 22% increase over reported cases in 2016 This count was the highest number of tick-borne diseases ever reported in a single year

in the United States and included 42,743 Lyme disease cases 7,718 Anaplasma and Ehrlichiosis cases, 6,248 spotted fever rickettsiosis cases, 2,368 babesiosis cases, 239 tularemia cases and 39 — 33 Powassan virus cases Under reporting as a common phenomena for most high incident diseases For Lyme disease, the actual number of annual cases has been estimated at 8 to 12 times higher than the number of reported cases And then a slide two references Under reporting also occurs for anaplasmosis, ehrlichiosis and rickettsiosis as well end of paragraph >> Great >> I move that we reinstate these — this into the report and accept it? >> I second that >> OK, we’ll take a vote >> Do we want to discuss it first? Are there other thoughts or? >> I have no changes to propose I think it states very accurately what the CDC data are >> Is there any additional discussion beyond what was already discussed? David, do you want to run through the vote? >> Yes >> Beto? >> Yes >> Angel? >> Yes >> Ben? >> Yes >> Denise? >> Yes >> Gene? >> Yes >> Kevin? >> Yes >> Leigh Ann? >> Yes >> Sam Donta? >> Yes >> Commins? >> Yes >> Scott Cooper? >> Yes >> Tod Myers? >> Yes >> David Walker votes yes, did I leave anyone out? >> I don’t think you called my name OK. Pat, you’re not on my list Pat? >> I’m not on your list Well that’s, I’m not going to comment >> I have list about people that are on the call and I’m going to on that list — >> Well, I had a power — >> If there’s anybody that get left off because they are not my list, I’m sorry that I didn’t remember you but that’s a thing of my memory, Pat Smith >> Yes >> Thank you >> Good morning, David Leith States here I called in late Yes >> Yeah. OK I think you must not be on the same– >> Dial in >> Thank you Thank you, Leith >> You’re welcome >> I just pasted what I read into the chat box, just so Jennifer, if that helps any with the documentation >> Thank you >> Before we proceed, I’m sorry I can’t type into the chat box I can’t bring up after my power failure I haven’t been able to get in Jennifer to asking me for a passcode I don’t know how someone can help me But I need to get back in online And it’s not running — >> Pat, just go in for guest Enter your first name and your last name and then hit enter You do not need to use the passcode Just go under guest, first name, last name, and then it will let you in >> Well, no, it says invalid credentials >> Aram, will you work with her separately to resolve the issue, please So Ben and Gene, are you able to close out the graphic and then start proceeding with the comments? >> Yeah, I think so Gene would you like to walk through these comments or you’d like me to either way? >> You know, before you do that, I’m sorry This is Pat again but I did have something that was in the background section And because of my difficulties here, I was not able to bring it to your attention while you were discussing that But then you have in the background section, you have a set — a portion that reads additionally, a National Tick Surveillance System has been established between CDC and State Health Departments that provides for annual posting of tick and pathogen distribution data based on active tick collection efforts And then you have a link to the CDC website?

Well, I went on to that link And basically, that link does not have anything about that surveillance system But it has a very nice colored brochure which is your CDC guidelines which you don’t but are there for providers and it has a few other links, it doesn’t have anything to do with that National Tick Surveillance System So I’m wondering why that would be in there and if that should not be removed >> That was in the first paragraph OK. Let me just check that link really quickly >> And that’s the link that says www.cdc.gov/tick/index.HTML? >> Yes, that is correct >> That goes to the main tick pages, and I’m looking at it right now says prevent by, remove tick, check symptoms, it’s got tick borne diseases that’s the brochure, it’s got where ticks live, it’s got tick surveillance And there’s a picture there right in the middle that shows a woman and tick surveillance And if you click on tick surveillance, it has the maps and the information on the national tick surveillance program >> I saw those matched but I did not see any information about that program I don’t see anything there that says what is that program? And how that relates to this, it does have maps, but I don’t see any relationship to that particular [inaudible] >> So under — So under tick surveillance, there’s a tab for Ixodes tick surveillance and non-Ixodes hard tick surveillance And if you click on those, there’s a link there that says surveillance for each of these And there’s a PDF-34 page PDF And that is hyperlink And if you open that it has all the instructions on how did these get identified? How did they get tested? How did they get submitted all of those things? It’s all right there >> So are you saying that basically, that explains the national tick surveillance system? >> Yeah, it does And what you’re seeing on the screen, if you scroll there, you’ll see the lady, it says tick surveillance, and if you click on that link, tick surveillance summary, actually — and have more time reading it here >> You know, the problem here is that by putting this link in there, we have not had a chance to actually review that link And it’s part of the report So I haven’t had a chance to review that link I’m reluctant to, for the moment to have a more general presentation other than the very specific parts of that tick borne disease surveillance data summary, which I think I’d be fine with But the rest of it, I think, stands to be reviewed >> So it was in what was originally submitted, like I said, someone inadvertently cut it out It’s actually still there, you know, and it’s fine to leave this out If in the review, you didn’t have a chance to click on that link and go there It’s fine And usually when you give data, you cite a reference for where that data came from And that’s all I was trying to do But there’s a lot of other data there It’s a web link And so, I’ll leave it to the group as to whether you want to include that or not >> Well, here is my concern, Ben My concern is that and I still can’t get in, so I can’t see anything online I can’t get into this meeting Because it still tells me I need a password So anyway, the point being is that when you open that up, you just see the links that you know to tick borne diseases, but again, you see a brochure for physician’s very colorful, nice brochure That brochure does indeed include, you know, it does not call them that the IDSA guidelines

And these are treatment guidelines for Lyme disease And so they’re based upon the Massachusetts rheumatological, whatever, by Nancy Shadick, and Nancy Shadick is a wonderful researcher for rheumatoid arthritis But if you go through, I went through 130 of her publications looking at what they were back to about, I think 2001 And there were four that included Lyme disease in there And they were mostly surveys, the rest were all rheumatoid arthritis, yet you have guidelines up there that are actually the CD — the IDSA recommendations, but you base it supposedly, on this Massachusetts paper I have a concern about that, because people are going to go to this page And they’re going to go to that And they’re going to see that it’s colorful, it’s right up there in your face And they’re going to go to that And they’re not going to see anything about surveillance, but they’re going to see guidelines, which only addressed acute Lyme disease using IDSA recommendations >> So one thing that could be done, there should — I would suggest two possibilities then I would suggest either leaving the URL out altogether, or maybe the other suggestion would be to click on the tick surveillance piece and go one level lower >> OK >> And so that people don’t see that if that’s what the concern is >> And that would be fine by me If you’re talking about I’m assuming the direct link to the surveillance piece >> Yeah, rather than the root page And so that link would be https: backslash, backslash www.cdc.gov/ticks which is all this here, and then slash surveillance >> Yeah, I support that idea I can understand that concern And then the also that the focus off of surveillance But I like your suggestion, Ben So I’d like option two >> Yes, I agree as well, and I think that the data that you’re providing And you’re linking to the surveillance brochures Children’s link website that’s got all of that information about what the CDC is doing about tick surveillance, is powerful, and is appropriate to have at this point And I think it supports what’s a statement says that your — you put in here as well So thank you for providing this >> OK. This is really easy edit where Jennifer, if you or someone wanted to do it, live after tick slash just put in surveillance And then the rest of it is surveillance slash and then index.HTML is fine That’s it Just add a slash and you’re good >> If we could just confirm with the working group that everybody’s comfortable with that just to make sure that that’s an appropriate affiliation Does anyone disagree with that approach? Because then I think we’re good unless we feel strongly that we need discussion or a vote I think we can accept that >> OK. I’m sorry to interrupt again But someone needs to send me a password I don’t care if I say that They don’t have one I need it into this system And that’s fine and I do not have a password And Adobe connect says I need one Someone needs just — >> We sent you an email, please look at the email They’re trying to get a hold of you without pulling you out into the operator >> Yeah, well, I haven’t been able to get an email That is the point So I’m trying the best that I can do >> So Aaron, go ahead and dispute over the phone line, then it’ll be recorded >> Hi, this is Kay Can you pick, pass — >> Yeah >> — code? >> Yeah, that’s a better approach >> So there’s no passcode She needs to close the browser that she’s in and she needs to pull it back up And then it says guests are registered user You just need to go under guest and enter in her name, and then choose Open application

in that choose Open an application and then it would let her in There is no passcode No one has a passcode to enter in Adobe >> While you’re doing that, as far as the other figures to be included, I was recommended that third one — that was there’s that first figure and then there’s the table And then there are two subsequent figures I think that the last figures, really not in this surveillance thing And in your original figures, the — that you had, that you were talking about before we go to the text there, right I think this third one That last one, I think is good, but this one that is being reported doesn’t need to be there then, because it really belies It doesn’t say as much as does the last figure So I don’t think we need figure 2A I think the last figure is the more important figures to show to emphasize where these ticks are really [inaudible] And then to deemphasize what are high and low incidence ticks? I don’t think we need to have that figure is there, yeah, when we already have this other very good figure that is called forth until the last That’s my suggestion >> Yeah, currently, that figure is not there It was, you know, part of what was deleted when it was revised >> What was deleted? >> Figure 2A, when I — as I mentioned, when I started, someone had cut out those — pieces of text And the one, figure 2B has been added into Chapter 3 But currently figure 2A is just out is done anywhere >> OK, thank you But it looks to me like this figure former figure 2B is part of this important surveillance data? >> Yeah, 2B is in Chapter 3 I mean, the question is, do you want to include it both places? And I thought we sort of thought we would just put it in Chapter 3 >> Just in Chapter 3, [inaudible] >> Right >> OK >> And my — so my question is, then, 2A, figure 2A, are you suggesting that you want to keep it in Chapter 8 or not? >> I think we’re saying right now that figure 2A is out And Sam was concerned about the content of it I know that Pat has also doesn’t like that concept, is the concept of having high and low incidence dates that are shaded And then the blue dots are dots of actual reported cases This is a snapshot for 218 And it sort of shows — it shows it a lot One of the reason, yeah, I don’t want to go into why this was developed This but all the say is right now is not included in our report >> Thank you for the clarification >> Thank you, Ben >> OK. So Leigh Ann, do you want to go back to the original chapter? I mean — the chapter that everyone has for SharePoint because I picked the rest of it I think those were the only areas where there was some concern to my point >> Yeah, just addressing the changes that were made and where we are at in terms of finalizing >> Yeah. OK, so, do you want to go through the comments? >> Yes, that’s it, continue with that Ben >> OK It’s hard for me to see what’s on the screen there, but I’ve got the document open on my desktop as well

The one that Jennifer sent out yesterday, so >> Yeah, does that window open up any bigger Jennifer and team on the screen, it would be beneficial >> You click on the Adobe icon on the top, and it says full screen >> Yeah, and there are too many comments I think if we go down to — I mean the first comment beyond the initial is where David says that he included an untested hypothesis of his about how non-pathogenic rickettsia likely develop antibodies I presume that it’s not the patients develop the antibodies that cannot be distinguished from those stimulated by pathogenic species >> And also Greg into that thought of that a long time ago, and that’s really doesn’t need to be discussed >> Well, I think that I don’t know who first thought about it I’m glad David to know, it was, you know, if you if there’s a reference to that, I’m glad to cite that That I mean, just as an FYI, that’s certainly our view at CDC and has been for many years And it began when we started seeing the explosion of RMSF, so called RMSF cases, you know, across the US and the, in the plummeting case fatality rate compared back, you know, to, you know, the ’60s and ’70s And those days and so, you know, we of course, know that the serologic tests, we almost never get paired Sarah for those cases, and so on one serology or you can really say is that spotted fever group and, but it’s nevertheless something going on that needs to be explained there And that’s why, you know, I went into that there >> Right. I don’t think we need to go into this any further We’re working on trying to sort this out, but don’t have the solution yet >> And so are you OK, with just leaving it as it is? Or, do you want that? >> No, it’s perfect >> Oh, OK All right, so we can OK >> Wait a minute, what are you saying leaving it as is leaving it as an untested hypothesis? >> Leaving the statement that he’s put in there as it is >> It simply says that there may be cross reactions with non — >> Yeah, I read it, yes >> — pathogenic rickettsia >> But it’s an untested hypothesis We have a lot of things that have been hypothesized and have actually have a lot of citations for them And they are not necessarily allowed to be included Why would we include an untested hypothesis? >> Because it’s 10 or 20% of people walking around with antibodies to spotted fever group rickettsia, particularly in the geographic distribution on the star ticks And people were thinking about what that might be due to >> I hear that, and I understand that But then again, I think that we’re going to change some language we have with Lyme disease, then and have untested hypothesis is in there Because people are walking around with chronic Lyme, and you don’t allow that, or persistent Lyme to be in our report Yet, that’s a hypothesis that many, many people have, and there’s a lot of citations for it >> I think for this particular statement, maybe the easiest thing is just say that many patients get out I removed the word likely, or just had to develop and — >> Just say may put — how about may, instead of likely? >> That’s fine, too >> You want to vote on changing likely to may? >> I hope we can just accept it, don’t you think? >> OK >> Well, I don’t agree with leaving it in, but likely is that I don’t agree with leaving that in there So that’s my opinion on it >> So we said change it to may instead of likely >> That is fine to me >> You could — sorry to muddy the waters and then but you could change it to variably pathogenic or something along those lines, because then it would read

as an absolute true statement for different rickettsia species like rickettsia parkeri which distinguish what by antibody from rickettsia It says just says that is going with the completely word non-pathogenic, you could say, suppose to variably, pathogenic rickettsia And then you don’t have to even have may or likely because, in fact, you’re exposed to something like parkeri, you do develop antibodies that are, as far as I know, indistinguishable from an infection from an infection with rickettsia rickettsii >> Well, I don’t think variable is clear, because the rickettsii either are or are not pathogenic, though, they tend to not be variable But you know how about other rickettsii? >> And just — >> The real issue is rickettsii antibodies And that’s what you’re talking about here It’s been an antibodies [inaudible] >> Ben this is good But I had a question, where does the statement come from? Is it in that Marshall et al., 2003? I’m just not sure where the statements with the source of that >> Yeah, the source of it is the fact that we have data that shows Rocky Mountain spotted fever cases have increased over the last, you know, 20, 30 years, and both in numbers of cases and geographic distribution And that the distribution overlaps the both the distribution of Dermacentor variabilis, but also the expanding distribution of amblyomma americanum, and during this time, we’ve seen the cases of Rocky Mountain spotted fever, case fatality rate really plummet And which is great thing, I mean, because it’s a horrible disease But when you try to explain why would you have more cases, and a much lower case fatality rate, it kind of begs the question, what’s really going on? And I think that what you know, most people think is, we know that all of those spotted fever group rickettsia, they cross react on the serology that’s used for Rocky Mountain spotted fever diagnostic tests And so, you can be exposed to parkeri or amblyommatis or something like that, and still test positive for rickettsia rickettsii Because they cross react And so, like you know, on the serologic test, so this is just trying to reconcile all of those things that we know to be true, you know, how can that all be true at the same time? And that’s, you know, this is what, you know, most people that work with these things, think that’s going on, and for good reason is that it’s not just purely speculative It all makes sense >> Right. OK Thanks, that’s helpful >> So I just think that Pat brings up a very good point that this the statement based on what you all just said, is grounded in science, but it is the source there to support it as a hypothesis Based on what you said, it’s certainly grounded in science is the animals data there or the data you’ve just commented on Because we don’t want to come across that we’re having our cake and eating it too, when we’ve had very contentious debate on the persistent line, just as an example, and arguing over whether the animal data supported that, you know, with different hypothesis and so forth, and then we have this statement being placed here I just think we have to be equitable and fair So for stating this hypothesis here, then we need to make sure that the source is very clear, as you’ve articulated it >> So my colleagues and I have infected guinea pigs with rickettsia amblyommatis They remain completely healthy continue to gain weight, had no fever, had no signs of illness and developed high titers of antibodies that are reactive with spotted fever group rickettsia, all spotted fever group rickettsia, for the animal data are there >> And so you’re articulating it very well I’m asking that it be sourced in the text >> Perhaps we could put this on the agenda for a bit later,

so that he has a time to get a reference for that And we can ensure that there is one >> I don’t know that given this meeting and the focus on the work that he’s going to have time to find that material right now >> Well, he could find it for it could be on the agenda next week >> Yeah, for the next meeting Yeah, I believe that Yeah >> So Sam and Jim, since you guys are the first up with a minority response embedded in your chapter, my understanding is from Jim and Kay, is that we’re not going to be addressing any of the comments in the minority response, because the comments are allowed to be made, as they’re, you know, subjective comments So, Jim, please correct me if I’m saying this, the way that I shouldn’t be, but we don’t need to address the comments We shouldn’t be addressing the comments relative to minority response Minority responses are, in fact, commentary and subjective, so that we shouldn’t be going into comments that are embedded relative to them in our responses, is that correct? >> That’s correct, Leigh Ann >> OK, so if you would like to move on, if there’s anything else in this chapter >> I think I get it >> So, this is Angel I had the first comment that happened to be I guess, within that minority response section that I mean, I think it’s a little bit weird that we’re skipping that It was a comment that I had brought up in Chapter 3 And it was basically just, I wanted to make sure that we are linking or connecting the concept of hazard versus risk between those two chapters, Chapter 3 and 8 And there was discussion at the July meeting, about making sure that, you know, maybe we’ve made that link It’s very clear in the background section, which we haven’t even talked about that yet today, understand that But, again, just in other words, making sure that we make a clear linkage between the tick and disease surveillance So I mean, while it’s in the minority response section, I don’t know It doesn’t make sense to me, why we would skip through those But — >> The reason we would skip through those is a minority in response is made from the minority people who did not vote for a particular thing The people that everyone who commented, voted for that particular thing, and so, that’s why you don’t comment on the minority thing, because you’re not the minority >> Right. OK I guess what I’m saying is, I don’t know, my comment doesn’t specifically speak to the minority response I just put it, it’s the exact same comment I had in Chapter 3 I just put it here to make sure that we make that linkage But — >> Yeah, I didn’t — and to be honest Angel I did not understand your comment Maybe could you make it, and what you’re saying that you don’t feel the minority response belongs — >> No >> — in this section? >> No. It has nothing to do with any of my feelings about the minority response or whatsoever It was this comment that’s here is exactly the same comment that I put in Chapter 3 And we talked about it at the July 8 meeting I think the decision was made that like in the background section, our first chapter, just to try to clarify and make sure that we make a clear linkage between tick and disease surveillance We talked about tick surveillance in Chapter 3, disease surveillance in Chapter 8 It was no, you know, it was no criticism of this minority responsible whatsoever, really >> So how would you — I guess I sort of hear what you’re saying now So how would you suggest that is done? >> Well, I guess we probably need to talk about it in the background chapter >> OK. That’s fine >> Yeah, I just, I don’t know I just felt we were remiss to just totally skip through this when it’s not really directly speaking to this minority response itself

Anyway, that I said my piece >> So certainly everyone has the ability to make comments in documents as they pertain to minority responses, or add their, you know, those sections It’s just that we were on I’m under the impression as Jim articulated that we’re not going to be discussing those at least in the meeting But the comments can certainly be added >> But, this is Beto to Angel’s comments, I’m glad you’ve raised that, brought it up for discussion again Angel, because looking at that sentence that reads Lyme disease exposure is largely driven by geographical terrain and climatic factors Actually, I would say that Lyme disease exposure is largely, largely driven by the presence of infected known vectors So with or the presence of known tick vectors infected with the Lyme Borrelia Of course, geographical terrain, and climatic factors influence the suitable habitat for the tick, but exposure is due to a bite of an infected tick So is that something we need to address or let it go or? >> Beto, you can address it, you did not vote against this particular thing when it came up? So you’re not in the minority >> Well, again, that’s just a common now, we’re looking at this And my comment is based on the point that Angel raised So that’s it — >> No, you’re trying to say that this should be changed that that particular aspect in the minority report should be changed And that is not going to be changed, because it’s not going to be changed And, so I appreciate your opinion, but you did not vote in the minority So you can’t — you voted with the majority to do what it’s not do >> Yeah, I think — yeah, now and that’s what I’m saying is I’m not addressing the aspects of the minority or majority It’s the language of the sentence >> Yeah, I understand that But that is the report, the minority report language >> Anyway — >> So we will have opportunities to still provide comments in the background section And perhaps that’s an area for some continual discussion on things that, you know, it can be elaborated on Let’s cross that bridge when we get there >> Yeah, and to your point, I think we are clear on that in Chapter 3 Yeah >> Thank you OK, so Ben and Jim, thank you for the review of this chapter Is there anything else you’d like to continue to discuss here? >> Not here >> No, I don’t think so >> OK, great So I think we’re moving on >> What about the last comment on page 7 and that’s still there? >> Yeah. It’s me again So there was a sentence here about the subcommittee also considered findings related to the potential sexual transmission of Lyme disease And I just simply raised the question about whether we might also want to touch on possible pathogen transmission via blood transfusion and stem cell products It was something that has come up within the public comments subcommittee, so I was just raising that for discussion over >> I think that there was something in some other areas that said and other forms of trends If let’s see the recommendation also again Go up just a little bit for the recommendation OK, further evaluation on bite tick transmission of Lyme disease, for example, maternal fetal transmission I mean that recommendation doesn’t say sexual transmission or stem cell transmission I think you can be OK with non-bite — non-tick bite transmissions

And it just said example, we didn’t want to emphasize a whole lot of other things Maybe we can include that, though Angel somewhere within the body of that particular description of the recommendations, if you’d like >> I think it should be included I — this recommendation gives an example And that’s fine That’s one example And I think that there are other issues And I think Angel touched on a couple of them And I would also like to see non-tick bite And I would like to see some mention of possible insect transmission Certainly, we know that mosquitoes and in a number of studies have been identified to be able to carry Borrelia burgdorferi And in one instance, I believe a biting fly in so, is there evidence that they transmit, I don’t know that there’s evidence that they transmit But perhaps, you know, these things should be mentioned, since they’re certainly, you know, might be something that should still be further studied Because there certainly are the individuals who feel that there may be other, you know vectors of this disease And so, I don’t know, I just kind of think that maybe this is something we want to include a paragraph or something about these other issues >> So one way we might do this without kind of getting again, into a lot of sort of speculative data, kind of going back to the discussion we had earlier, maybe we could just say, at the beginning of the second paragraph in that section, where it says additional studies of the incidence of potential maternal fetal transmission, add a phrase there in other nontraditional routes of transmission of Borrelia burgdorferi I could provide the information to help answer you frequently asked answer — ask questions, blah, blah, blah I mean, could you just add something there to say that we’re encouraging additional studies in all of those areas? >> Well, I think — >> Maybe if you — >> To use not maybe >> I think that’s a, you know, certainly something that can be done, but it doesn’t We all know, if something isn’t specifically named, that it ain’t going to happen, even if it’s specifically named, it may happen, not happen But I think that we could put that in there and maybe give several more examples, including blood transfusion, stem cell products, you know, and other, you know, perhaps other, you know, insects I mean, I think that that’s all that needs to be said, I’m not saying you have to get in the [inaudible] with those But I think it should be known that these are areas that should be looked at >> OK >> And the — you know, we can include that in there >> I’ve had the issue of other insects I think has been adequately studied They certainly can find them But the ability to transmit the evidence shows that that has not been the case And there are studies there And I don’t think we can go into that because what you’re inviting here is additional speculation that there are these other possible things So you’re going to have people saying, oh, I got a mosquito bite, I could have Lyme And really, the evidence says no on that I think it’s reasonable though to say something about blood transfusion, even though there have been studies that show that there has not been any credible incidence of blood transfusion, although it could be theoretically possible within the first month If a person is ill and carrying Borrelia in early Lyme disease, I don’t mind I don’t like to extend that sentence I think we can provide And let me work with Ben and Jane on providing another reasonable sentence We have not included breast milk here We’ve discussed all of this in our subcommittee, but decided to just say something about maternal fetal transmission, which we know takes place as far as during the fetus

But as we say later there, we don’t think there’s any congenital Lyme disease per se that continues on into pediatric life But if you’re OK, why don’t we work on this? But I don’t want to extend it So, all theoretical things And I think we should be reasonable And it seems to me the maternal fetal was the primary thing The sexual is an interesting aspect of it, because it’s out there And I think we can include a breast milk just although, I’m not sure that happens For further study and the stem cell, of course, but that’s kind of relates to blood transfusion in stem cell But I’m not in favor of bringing up other insects that’s been discussed And I think found not to be the case fairly reliably So why don’t we just focus on this, including these other places, albeit less likely So if you’re OK, why don’t we — I can help and maybe my co-chair can help with working with Ben and Jim on some other language here So we don’t belittle this, or take the time here to try and put a phrase or two, we have ample time in the next section to finalize it >> Well, but you know, what I would say — what I would say to you is that there, I believe that there’s more research is needed in that area, it’s the same thing when it shut down that Bartonella is not a you know, a tick borne disease Despite the fact that it is found in ticks, there was even one study that showed a transmission And yet the government doesn’t want to acknowledge that Bartonella is a tick borne disease, and it doesn’t look like they’re doing any that I can see studies to show that And so, I believe they have shown with mosquitoes, biting fly, maybe with other insects that I’m not aware of, that they indeed have and contain or can contain Borrelia And I think, you know, to shut the door on these things, is a mistake when we see the numbers of cases that are occurring And it might provide answers to some of the areas of the country where there are less, supposedly, you know, less black legged ticks And yet they have Lyme disease, even though we try to, you know, as a government shut that fact down that some of these states have Lyme disease, but as you know, as far as I can determine, based on the data that’s there, and it may be it’s a hypotheses, but it is a hypotheses that a lot of people have, that this disease is in all 50 states and being transmitted in those states So this could possibly provide answers as to why that’s happening If there’s an insistence that there’s no tick vectors that are transmitting it there, so that I’m all happy with you guys going back and working up language But would I like to see that, yeah and I’d like to see the breast milk because we know that the DNA has been found in breast milk And I believe there was at least I think one animal study that might have shown some transmission And of course, with the blood, we know that the blood banking, you know, the Borrelia has been known to be able to survive in blood banking conditions, under blood banking conditions So, you know, whether transmission has occurred, that obviously has not been proven And so, I think we have a whole wealth of things here and to neglect some that, you know, that need further study, I think is incorrect And we’re not saying that all these things are going to be done But we’re pointing out that these are possible areas >> So possibly a solution supporting Sam’s approach is, from a prioritization standpoint, listing them in some order of importance, trying to be comprehensive, but if we throw the kitchen sink out, then sometimes the lack of focus can, you know, actually not support the argument So if you’re lifting them in terms of priority, what you would put first, what you would put second, what you would put third, you know, even if it’s just in a parentheses But understanding that we want to show that it’s good to study those important areas

>> One important procedural, I think, if I may call it that way is that we had all of these subcommittees that studied very focused questions And we knew at the outset of our beginning meeting, that we weren’t going to study or revisit a number of areas, for example, vaccines that was visited in round 1 So I think that whatever we haven’t discussed, and we did not, for better or for worse, discuss, breast milk, we did not discuss stem cells, or blood transfusion, we actually went by it very quickly So this is a topic perhaps for the next round of the tick’s disease, just like this round is a little more focused on rickettsia, in addition to Lyme So, you know, obviously, my focus is on online and on the continuing line So this is a question that you legitimately raised And we certainly can go ahead and try and go into the references, but it’s like we’re doing subcommittee work again And I don’t think at this stage, we should visit areas that we were not assigned to visit, and try and make a decision about that I don’t think that’s fair This working group is supposed to review what we already were tasked to review, and not to bring up new areas And if we were deficient as a subcommittee, or as a working group, and not bringing this up Well, that’s something then for future considerations But I don’t think I want to take the onus of trying to sort out here in the last two or three months, without having other advice by subcommittee members, for example So that’s my view, and I appreciate your concerns and your opinions on this And hopefully, we can try and resolve these as best we can for this particular report >> And I agree with Sam Yeah, I totally understand what you’re saying Yeah, because I think it’s not a good idea to get into yet opening up a huge area of discussion But I think it’d be missing one important point that Angel brought up as a member of the public comments subcommittee, is that particularly the blood bank, you know, the blood supply issue? And the impact there, I think it certainly Yeah. And again, I’m not saying open it up to have, you know, paragraphs of discussion on it But I think what we’re saying we’re going to do it sounds like we need to take notice of it, we need to show that we’re responsive to the public comments We — the way the recommendation is written, certainly allows for that, you know, it gives us logical outgrowth, to talk about these other things We didn’t rule out anything by giving an example So but I think we do have to keep in mind because there’s really, there’s no chapter necessarily that is focused on public comments and that subcommittee We always have a report and an update from them, which I think is important, but I think we also have to give notice, when certain things are coming up time and time again >> Well, I have to say that, Sam, I respect what you said, but the fact that what were the things that we included last time, you’re saying we cannot include, again, in a report, or it has to go in the next report that I don’t I certainly don’t agree with that And also, if it’s brought up in this report, it doesn’t have to be in depth, it doesn’t have to be anything in depth, but that it is mentioned in this section in this report, that means that the next working group can then use that material, just like some of you have used in your chapter saying that in the 2018 working group report, this issue was, you know, made, you know, was brought to light and we’re you know, doing further work on that or whatever And then you know, the next working group can say that, you know, these issues were brought to light in the 2020 report, and now they can be further discussed And I think that again, this particular recommendation, as I recollect was not you know, this was this recommendation was changed from what the original recommendation was And it was, it was boiled down to evaluation of non-tick borne of non-tick bite transmission,

and those other issues that were all mentioned, including other insects, or all other methods And again, you don’t have to be going and looking for 100 citations You can, you know, there can be a citation for each area, you know, whether it’d be the blood, whether it’d be the insects, whether it’d be, you know, the organs, you know, and so on, and so forth And to say that we’re not inserting new material, you know, well, if you remember that this whole process, in my opinion has been subverted to start with, because we were originally told that we couldn’t do anything except pull from the subcommittee reports, we were specifically told that, and then after we did that, or at least those of us who follow directions, did it Then suddenly, we could now everything was, you know, out there for discussion and inclusion and voting upon and voting out So therefore, yes, we do have a right as a working group, to put these things in there And I think that this provides a basis for the next report and places to look I have no problem, by the way, with Leigh Ann mentioned the possible priority list, if that’s something that could be developed, hey, let it you know, that could certainly work You know, how I mean, I don’t know how you would establish that But perhaps the things that have the most, you know, things they could be put in, you know, or I don’t care even if the insect 1 is just put last in the listing of that, I think that it’s important that it, it’s raised, and it needs to be looked at, it’s something that, like everything else was with many of these tick borne diseases, these things are looked at, and then the government puts their stamp on them And then they’re dropped And they’re not really looked at And I think they need to be relooked at because they have a possibility of answering some of the questions that are out there about why these tick borne diseases are appearing in places where we don’t think they should be perhaps, or at least the government doesn’t think they should be >> So good discussion, I think if we’re comfortable moving on, we can trust that Sam will help to wordsmith the statement And since, we don’t have the time today to be doing wordsmithing by comment And he’ll take into consideration that discussion points that were made, whether it’s keeping more of a general statement, or including some of the specifics Does anybody have a problem with that? Or, do we need to proceed with the vote? >> I’m fine with that this is Ben I just feel like we should try to remember — we need to remember, this is a report to Congress And by including anything in here, we’ve essentially prioritized it already And I think if we just go back and list a laundry list of things, you know, and then — can you hear me? >> Yes, we can hear you >> Yeah, OK, I just have a network glitch here Suddenly, network connection was lost OK. So anyway, we — I just — I think we better just to keep it general And not like write a whole new paragraph on all the possible ways of transmission and prioritize those And then we’re going to have to agree on those and vote on those, I just think it’s going to get lost to Congress You know, we want to — if we want to placeholder, let’s do that, but let’s just keep it kind of general and high level for the audience especially >> Yeah. And I just want to add that my suggestion on waiting or prioritizing it was not meant to be, like I said, a kitchen sink list, either It’s just that if we’re going to prioritize a couple, or just a couple of perhaps put them in order, you know, two or three So, anyone else with comments before we try to move on? >> You know, I think we’ve decided to go back to Sam and Jean, and they’re going to come forward with what they believe is proper And we’ll vote on this next meeting >> OK, thank you, everybody for the discussion We’ll move to the next document then for the next chapter Thank you, Jean And thank you, Ben >> Thank you >> OK, so David and I tried to tackle the looking forward chapter

This is a chapter that was also in the previous report to Congress And the title really implies the intent So, I don’t think we need to get too repetitive But the setup for looking forward is obviously to angle, if you will, some of the potential areas that might be tantalizing or appealing as we, as I put some topics in front of Congress So we’ll go ahead and get started David, do you want to start leading us through? >> OK, yeah, I will bet Thank you probably, or so and — to begin with, we’ve got some comments here on the recommendations from Eugene Shapiro And of course, the recommendations cannot be changed >> And have been approved already, so that — >> That’s exactly what I was saying But I was muted I’m sorry They’ve already — they’re not subject to being changed Can we enlarge that a little bit? I’m having difficulty reading it OK, so now, the next comment By from some is from Angel And she’s highlighted the sentence The 2020, tick borne disease Working Group addresses critical needs of — areas of need, yet more can always be done And she says finish the thought here, Angel, what are you proposing? >> Well, I think when I put that there The word done wasn’t in there It was just an incomplete sentence So I think it was wrapped up So I think it’s a non-issue >> Good. So the next comment Again, from Angel, and she report to Congress So is Congress considered the stakeholder? Congress provides targeted guidance and can add funds to budgets How about federal agencies like ICDC, Department of Defense, CMS? Are they stakeholders, local, state health department’s industry, private companies, from the tropic organizations? So what is your suggestion here that you would like to see us address Angel? >> All right, so this is quite a while ago, and I see that Leigh Ann provided some comments, it seems like this was pertaining to a figure that we’re not actually viewing right now I think I was just bringing it to the attention of everyone If we’re going to list out some stakeholders, you know, are there others that we should indicate as well? I don’t remember what this graphic looks like at all >> Yeah, let me jump in Angel Thank you >> Yeah >> You’re correct So the intent of this topic, broader collaboration, as a path to innovation and quality care, as you know, described in the topic is more in the total looking forward aspect The graphic is supposed to show pictorially, that we have some circles of all the stakeholders that are already involved So they’re certainly there, to your point, yes, Congress in there is their provider’s and their patients and advocates or their researchers, et cetera But then could we have a graphic to help to show that it would be beneficial to include other stakeholders in the picture, if you will? And what is the value of that? The value would be further innovation, further ideas and some other benefits that are kind of described in the paragraph, and just using the graph to help demonstrate that, and some of the texts that continues to go below on some of the other added benefits Bringing into the fold more stakeholders, not necessarily on the core group of the working group, but even ad hoc and such, and so forth >> So who’s going to develop this figure? >> It’s — I believe Jennifer, she’s able to comment it, the first version of it is already under development And we were hoping to have that to be included But it’s not available as of now So we’ll have a chance to respond to it and then make any comments if folks like it or don’t like it or we accept it or we enhance it >> So this satisfies me Does anyone else have any further discussion of this point? Here now is [Inaudible]

>> Yeah, now, I have a lot of discussion of this and generally of this chapter, I’m really confused, first of all of this discussion of more stakeholders You know, first of all the legislation basically provides what the state — who the stakeholders that will be seated on the working group are And if each working group decides to bring in people they’re certainly — they certainly can bring in somebody who put them on the subcommittee, which has been happening, but there’s a huge focus here on industry, you know, bringing all these industry people in, and so on, and so forth Well, industry is all well and good However, you know, this working group was supposed to be about, you know, basically, the bottom line to patients And what can the government working with the stakeholders in line, who are, you know, the physicians and medical providers, the scientists and researchers with expertise, patients and their family members and nonprofit organizations And so, by leading together, they are supposed to be providing to Congress possible, you know, solutions, things that the government is not doing, and so on, and that need to be done to address these problems And so, you know, yeah, I have a lot of concerns about this, and about this whole emphasis on industry I don’t think that that’s what this is about And also, I would like to know, the recommendations that were put in this after, could we be provided with where each of those recommendations came from? Because, I’m not sure And I didn’t, unfortunately, have time to check each one out as to where these recommendations came from I know, several of them And we voted on those But I don’t know, you know, about some of these others, whether we voted on them, or we didn’t, or these are voted on? And why are they in this chapter as opposed to some of the other chapters? >> OK, so let’s back up if you just scroll up a moment Or sorry, scroll down a moment So the — these recommendations came from, actually your subcommittee working with David on the federal inventory And the focus on industry, I would say that it’s not a focus on industry, its one portion of suggestion, which is to improve the collaboration with industry, for the common goal of serving the unmet needs with patients And that’s what the text are these too >> What about the framework being a regional healthcare system? I mean, I — you know, this, you know — >> But if you — if we read that — if we could go down to that example, that example, actually is borrowed, if we go down to the graphic, which is some cancer practice model Please continue going down, please, keep going Keep going Keep going Right there OK. So that’s the framework That is a suggestion And it doesn’t have to be the one that we use I’m certainly open to any other suggestions Looking for a source here, just as you would continue to collaborate with all stakeholders and agree with your point this the grounding of keeping the tick borne disease working group in tact with who the fundamental stakeholders are, but just improving the collaboration, one stakeholder group being industry, other stakeholder groups to go back to our values, which we talked about up front, those values being to improve innovation to keep improving the reliance on evidence and patient-driven and physician-driven evidence One means of getting to that is to extend the outreach to other stakeholder groups that we are currently working with And so, here is the framework when you look at stakeholder collaboration,

have another idea of way to do that Within like, as a model, I’m not saying this is what we need to do But this is a way to get to how do you improve outcomes and reduce costs? Something like this could help the whole tick borne disease effort And there are already pieces of this that we’re doing But what else can be done to help increase collaboration with the whole common goal of improving cost efficiency and quality outcomes for the benefit of patients? But so this is kind of alluding to just what we could continue to do and looking forward in our future of just steps by steps for constant improvement And so, if you read it from the top to the bottom, it’s just kind of checking the boxes on where are ways that we can keep taking improvement steps >> So Leigh Ann, are you saying that that example for that example at this moment version of Figure 9.4.3 is just for illustration purposes, and you will adapt that? >> Yeah, that example was just an example for illustration purposes, correct And it’s just showing continual ways to improve collaboration, driving greater outcomes and reducing costs We don’t have to use that example I’m just — I’m showing frameworks or as I do to a front, as we wrote some of the texts, as we bring in, you know, we go back to our values, what are other ways you can think outside the box, as Jim said, right up front? What are other ways we can fold in innovation? What are other ways we can improve, you know, and tick the box on evidence So, if we look to our, you know, friends and colleagues and different care models, like you know, different therapeutic care models, what are ways they’re doing that perhaps tick-borne disease can also mimic or borrow some best practices? I think if we talk to some of those stakeholder groups, we can possibly include some of those ideas and help better serve patients, including industry, and including other stakeholder groups And that’s what this chapter was meant to acknowledge >> Thank you for the clarifications >> Now, all I can say is I hear some of what you’re saying and get some of it But to be honest with you, most of it, I think, is not something that, to me, looks like something that the Working Group would need to take on to do its mission If we want to put industry people in, we certainly can add people that do the subcommittee’s can pick them for their subcommittees When I see something that says framework for creating a regional health care system, that brings immediately to mind politics? And, you know, I think that’s problematic I don’t think that we need to include that in here I don’t think that Congress, you know, we always talk about, well, let’s look at the audience, and what are they going to understand Well, Congress is our audience I think they’re going to look at that and not really understand necessarily how that relates here And so, I personally feel that, you know, I’m not at all real happy with the direction that this chapter has taken And I think that we need to go more back to the basics, because quite frankly, the stumbling blocks are things that we haven’t been able to overcome, at least not with this Working Group And the stumbling blocks still come from entities that want to deny these persistent infections and chronic infection, whatever you want to call it, and don’t want to take the steps necessary for research and education in those areas And until we get people, you know, that are willing to address those issues, and not — and stop putting those obstacles out there, we’re not going to get anywhere Because getting somewhere means helping the patient We’re not going to help the patient with a lot of these things that we’re talking about So, that’s my considered opinion, and I just think that this chapter certainly not, you know,

talking, it devotes quite a bit to industry and other issues like that And I really don’t think it’s what this Working Group should be, you know, talking about We’re not here for industry Should industry play a role? Yes. Again — And they can We can have people, again, who are on the subcommittees If you want to select somebody from industry, as far as I know, there’s nothing that prohibits that >> So, perhaps including the framework for the health system is not unnecessary graphic at this time But I fundamentally disagree that the inclusion or the elaboration of the need for industry in looking forward is not necessary And here’s why As stated in the text, one of the things that I believe is happening with tick-borne diseases as an area is I don’t believe it’s clear across industry that there is an unmet need that exists with patients I don’t believe that’s clear And through no fault of anybody, you know, any particular person or reason, that has to be what is very clear Industry — And the industry is made up of people, just like you and me Industry has to understand that there’s the unmet need that they have to then invest research in to pursue therapeutic development And until that is very clear that there’s an unmet need, whether it’s in acute or chronic settings, there can’t be that ongoing innovation And so, this isn’t a matter of putting somebody on a subcommittee, or putting an industry representative on a Tick-Borne Disease Working Group This is about much bigger than that It’s about far reaching collaboration so that things that are concerning to all of us are happening Unmet need gets addressed, research to fill gaps gets addressed To check the box in many areas, not just scientifically, but much bigger than that, to get to big issues, like you talked about — all of us talk about And so, that’s why I think looking forward has to have the inclusion of industry as a stakeholder group And then I tried to give some examples on what that could look like >> But I have a comment about I think one of the problems that we may discussing is the title here I don’t think we want to refer to anything about regional healthcare system, because I agree with Pat in this regard that that implies politics in too much direction But I agree with you about industry needs to be involved The problem here, specifically regarding Lyme disease, and perhaps the other tick-borne diseases is that the main antibiotics that are being used are generic And they have that — We’re not going to have any industry interested in conducting any further research into that aspect They’re going to concern about their new antibiotics And, you know, being an infectious disease over the years, you have another need too, cephalosporin, or what have you, that you don’t need that is much more expensive That’s what the problem with the industry being involved But I agree that we need their help to find a new marker I don’t know that it’s just independent researchers are going to do that But I think that if you remove that word regional, I mean, that’s something that somebody else >> No, I’m fine with removing the whole pair model aspect The whole political piece is something I didn’t really consider So I think that whole section can come out >> Well, if you want to But I think the idea that you had was good as to how to begin to enjoin industry in an appropriate fashion But if you want to remove it, that’s fine I think the regional health care is not appropriate, though, for our consideration >> But one more point here that I believe is in the text having worked on the elaboration of this area is so, yes, the generic antibiotics are part of the treatment protocols And so, let’s just say then, make a generic statement here Industry is not interested in doing research because generics antibiotics are being used

Well, they’re not all working for everybody And that’s not to say that innovation for antibiotics can’t continue to occur to help address, you know, we’re saying Lyme obviously in the statement, can’t continue to occur But also, we’re forgetting the whole aspect of all this symptom management that needs to occur as well And maybe that’s beyond — that’s further down the road after the cause isn’t better understood But the industry has a role in helping to take — helping to manage symptoms, even when the cause of etiology itself isn’t always still understood, and even when the patients are on antibiotic treatment as well So there is this chronic disease aspect And since the management aspects that they would have, as the education aspect of all tick-borne diseases is understood, there’s still a very, in my opinion, a lot of interest, once the unmet needs are very clear But this all starts with much better collaboration and education >> Well, Leigh Ann, I’m sure you know, a lot since you listed yourself as an industry representative on the Board And so, but here’s the bottom line, industry does not want to touch Lyme disease, and they don’t have that — we don’t have a test who has to determine really who has a disease and who doesn’t makes it a big controversy They don’t want to go near it They know that there are problems There’s no way that industry does not know that there are problems, the industries that are associated with health care They do know there’s a problem, but they don’t want to touch it And so I don’t — the way we have to go about it is we have to be the one to get government to focus on getting appropriate testing, testing that we can rely on, testing that can determine active infection, and so on And industry, quite frankly, isn’t going to do that They haven’t done it They haven’t wanted to develop the antibiotics that we’ve already mentioned And so, we have a job, and our job is to convince Congress to, you know, have these programs come forward And I think that all this focus, I don’t mind a mention of, you know, bringing industry in on — in, you know, as far as, you know, when there’s subcommittees or something like that But to have all this emphasis, I don’t think that that’s what this Working Group is about And I think that’s changing the character of what this is and what it’s supposed to be doing >> Again, I thank you, David, closing comments there Again, I remain steadfast that you cannot — we cannot be successful and continuing to advance the way we need to advance without collaborating with industry And if there’s assumptions being made that they have not been collaborating, then we need to fix that And there needs to be a better starting point And I think that all of that can be improved upon >> Yeah. We can fix it by getting better tests, and having the research into the development of those tests And once those tests are out there, the industry will be clamoring to do something about it >> Thank you, David Go ahead >> There is — Pat’s right You know, the important new test and the thing she’s mentioning are absolutely right And they are in the recommendations of this report The precedent of this chapter from the 29th — 18 Working Group report, is it has two components, one, addressing the federal inventory and recommendations that will come from that And two, it is an assignment to the co-chairs to point to the next Working Group with suggestions of what avenues to pursue And so that’s what Leigh Ann and I have done >> Dennis here And so I wonder if it’s a matter of looking forward and how far forward you’re looking And so, I certainly agree with Pat that we are studied now at the diagnostic side, and it’s so limiting in so many diseases And I won’t bore you with the list of the ones

where I’m disappointed, but it might sound better But you might go on to say stepwise what the next steps would be, and how — what the limiting ones are so that ultimately you could then bring in industry for the must needed develop in your approaches, both anti-infective and non-anti-infectives for managing the signs and symptoms So stated that way, it’s not we got to do this tomorrow >> Thank you, Dennis >> For the — I think the recommendation right now is regarding industry is maybe those couple of sections can be reworked I suppose that the language is softened or more redirected as to what the role of industry can be And I appreciate both Pat’s comments and yours, Leigh Ann So maybe you can work with Pat on — and Scott on how to rework some of this language >> And this is Alberto >> The regional healthcare system is going to be too hard to rework Maybe that could be rethought and deferred for later >> Yeah, I don’t have a problem with that >> And Leigh Ann and everybody, if we will help, just because I have this on my notes, to provide context on this aspect of the involvement of industry and raising awareness with industry on the relevance of this problem with tick and tick-borne diseases in public health In — On the side of certainly mosquito-borne diseases and more specifically, with agriculture, there are two examples that maybe we can borrow from that — from them One is the Innovative Vector Control Consortium, and the other one is the Foundation for Food and Agricultural Research that stimulate — that supports innovative science to address today’s food and agriculture challenges through building unique public-private partnerships to support innovative science addressing today, in this case, is we’re in agricultural challenges but it could be — the same could be said for tick and tick-borne diseases for our case today So, just those two comments on similar approaches to the same problem that we’re discussing here >> And Leigh Ann, I think the figure, the main problem is in its title If it talk about health care systems, I think it would actually largely be right If it was improving health care of patients with tick-borne diseases, it probably the elements within it are exactly what a lot of us would like to see >> Yeah, that’s what I meant too >> I’d be interested in comments on the rest of the Working Groups before we consider keeping that in And not — obviously not that graphic, but the text component that reflected the goal of improving health outcomes and, you know, its cost efficiencies on behalf of patients >> So, are you saying making up your own graphic? Because obviously, you can’t — >> Yeah >> Because you couldn’t change that >> Yeah, yeah, yeah I wouldn’t steal the graphics text But, yeah, like — And so hitting on the points that usually drive quality and programs or outcomes >> Certainly a possibility, if you were careful of your word choice Yeah. It would certainly change, in my opinion, the perception of what that graphic is And, you know — >> Yeah >> — under those points are valid >> And I appreciate your commentary about the system language being a little bit cross stitch at this stage, at least So thank you for that I will — I’ll work through that Anything else? >> I think a lot of people reacted to the regional health care system wording It makes you think of Kaiser Permanente serving 35% of the California region I don’t think that’s what you mean I think it is — >> Yeah >> — the key elements of success of integrating the vital parts necessary for a good outcome

>> All right But I want to put an IDN graphic in there like Sutter Health, but we’re pulling the language together Let me think that through Really good comments Any other questions or concerns or comments? >> Well, maybe before you spend a lot of time doing that, Leigh Ann, Pat, how does that overall idea sound to you? Would you be able to work with Leigh Ann in principle on something that sort of pulls together how we’d like all of our efforts to reinforce each other? >> You know, certainly I would, if I have the time, and I have to see what’s going to happen to Chapter 7, because it seems like that’s continuously being decimated And so, I have to see what kinds of, you know, what has to be done with that before the next meeting But if there’s time and energy before the next meeting, I will certainly be happy to provide comments, do anything that Leigh Ann puts together I would prefer that the comments are made in public That’s my thinking on it >> So we have later meetings scheduled around graphics? >> Yes. I mean, the next meeting is devoted to various chapter graphics Yes >> Next week or subsequent to that? >> I don’t know what subsequent No one’s told us with any of the other meetings are for that I know about Maybe it was on the slide that went by this morning, but it went by too quickly And I could not tell on that timeline what’s happening in the October meeting In fact, that was the first time I heard that that was the date for the October meeting So, I don’t know >> Yeah, I was assuming it was things like graphics Maybe Jennifer can clarify >> Jennifer, do we have you on chat or? OK. We’ll have to circle back with her OK, David, did you want to proceed to any of the other areas here? >> Sure. Let’s move along Yes, let’s move along So, I got a couple of places here to take — to strike long-term damage from other tick-borne diseases It’s a real disservice to those acute life-threatening diseases to drag them into the chronic disease category And it really can confuse patients Many of them get anybody tighter when they’re due to rickettsia or Orientia, which proportion of people have that undiagnosed infections with that, and it’s long over with And there’s no evidence for these chronic diseases And so, I clearly don’t want to bring them I really would like to not have them included in chronic disease manifestations >> OK. OK >> And so then, now, it come down to this chapter of seven herbal extracts And I just don’t think that there’s adequate support to conduct human studies of these projects Before you go to human studies, you really need to do a bunch of animal studies that evaluate whether they’re absorbed or not, what kind of concentrations they get in the tissue, how long it takes them to get distributed What the hell they’re — What they’re metabolized to, how long it takes to clear them, and whether their — what their toxicity is? And that’s a — So I really wouldn’t use that example there I think that that one is just too far away It’s something that’s been done in a test tube, and it really is far away from what you would need to have before you would doing human studies clinical trials >> And that’s actually proposed in this wording? >> Was this proposed? Say that again >> Are human studies proposed as the next step? I didn’t gather that from — >> No, no No, no. Well, with the multidisciplinary approach is what’s proposed is, again,

going back to the conversation earlier that what can be learned amongst tick-borne disease threaters, researchers, scientists by collaborating across other therapeutic areas And then as an example, you know, as an example in oncology, natural medicines are being used, what can be learned by, you know, kind of cross breeding, if you will, cross talking with the oncology space Are their natural therapeutics that can be, you know, just by having some, I don’t want to use the word cross contamination, but cross discussions, cross collaboration, cross disciplinary approaches, what can be learned by more collaboration For example, this study, it talks about natural medicine, could something like that be learned to help improve upon tick-borne diseases So things like that There’s a lot to be learned in terms of innovation by more and multidisciplinary approaches and collaborations >> That’s certainly I don’t think so we’re ready to randomize and do a study right now But this is similar to an effort undergoing and underway of agriculture, and I participated in all three of the alternatives to antibiotics in agriculture meetings And so, there’s so much activity in Asia People are getting away from small molecules and moving toward deciphering the mechanism of action of traditional medicine in the laboratory discovering cytokine signaling pathways, discovering actually new immune cells in the gut So it’s the concept of exploring alternatives at the appropriate level and proceeding in sequence Because people are not moving those into people, they’re just looking at it, and they’re looking — they’re gathering that kind of evidence David would like to see to evaluate next steps So maybe there’s a way to frame the wording in that context? >> Mm-hmm It needs to be very clear on the evaluation of next steps by more multi by — whatever, stick with multidisciplinary language, but to keep that multi — next step more general, and clear >> The last one we discussed understanding mechanisms of pathogenesis, and then looking at mechanisms of interrupting that process through such as alternative therapeutics >> Right >> Right >> Infection is — Could you remind me under which recommendation we’re discussing this? >> This is under the part that has to do with the co-chairs putting forward suggestions to the next Working Group >> But what to investigate? >> Which recommendation? >> It doesn’t have to fall under recommendation Looking forward has some liberties where, you know, as co-chairs, we can make some recommendations overall >> So this is an additional section to the forward that we already discussed? So is this — Can you move the slide? >> It is — Yeah So just like the 2018 report, looking forward is in the very back section >> No — >> But it’s still — >> Could you move this particular slide up so I can see what’s repeating what’s called multidisciplinary approach? Further up, OK Oh, so, no, just keep going up further So this comes under after we’ve discussed 9.4? Is this part of 9.4? >> No >> They’re not >> This is separate This is separate >> I don’t know what [inaudible] mean >> That’s recommendation 9.4 This does not pertain to the recommendations This pertains to Leigh Ann and I making some suggestions to the next Tick-Borne Diseases Working Group avenues to follow >> Why do you need to make any further suggestions other than what we already decided where the recommendation — >> Well, that was what was done in the previous report We were just following the pattern that was set — the precedent that was set >> And so, those recommendations came from the federal inventory >> Right. But this is in addition to what our federal — >> That’s correct >> — group — >> That’s correct >> So I’m not sure it’s necessary to go ahead and include any of these So I would propose deleting this whole section >> Well, I don’t agree with that I think there’s value in making some general recommendations, one section being on the need

for improving the collaboration with the industry One is improving the outreach from a multidisciplinary aspect, or if you want to tem that just differently And I tried to give an example here of why that would be beneficial And then, Dennis kind of layered in language that can make it a general statement to bring it closure in the section there >> It certainly is confusing having it fall where it does within the recommendations being addressed So I think at the very least, or the options don’t include it, or do include it, but include it separately in another section entitled thoughts on next steps from the co-chairs, so that’s clearly identified as very high level Like you would do in a paper in the discussion section, sometimes people share their thoughts on what should be done based upon what they’ve already accomplished >> I’d agree with that, because being part of the inventory committee, I don’t think we knew that this was coming So I didn’t mean to be too abrupt by suggesting that it all be deleted There are elements of this, though, that we did not discuss in that subcommittee And so, I’m not prepared right now to — I know I should have reviewed this already But I think this is another example of where the subcommittee looks at certain things, and now, one of the members is surprised by this particular thing But I could go along with Dennis just saying something from the co-chairs And then if it’s subject to review in votes, and I’m happy to relook at this and see I think it overemphasizes, in my estimations, the alternative approaches And I think there’s a lot of interest in it out there Myself, from extensive clinical experience, have not found substantial improvements coming from some of these approaches, but some of them are further — are worthy of further study So if you want to, again, try and say it’s your opinion, I don’t know Is that — Was that, David, in the last report is — >> Yeah, we’re just following the precedent of the last report >> And the other — >> The last report working — >> Yeah >> This chapter contains the recommendations of the Federal Inventory Subcommittee And it assigns to the co-chairs the opportunity to forecast some things that they believe should be looked at by the next Working Group Just following the precedent of what was done last time, what we were told to do >> So John Aucott and his co-chair had a section in the last report like this? >> Yes >> Yeah >> They had a section, but it didn’t look anything like this, I can tell you that No offense, but it didn’t But I will say that, Sam, I think a good percentage should be either reduced down or removed But I don’t agree with the, you know, the issue about the possible alternative approaches, because right now, unfortunately, we don’t have a lot of things that focus on things that have meaningful effects on patients And as you did indicate, some of these alternatives, you know, modalities do And I think that they are something that needs to be looked at down the road And it’s not, you know, a bad thing to have something like that in here to indicate if the Working Group agrees So I don’t think it has to be — it should be just the co-chairs agree I think it has to be whether if the Working Group agrees to have a segment, and it doesn’t have to be this maybe extensive on these natural other kinds of alternatives, whatever you want to call them I think that that they’re very important, and they have been denied to our patients under the IDSA guidelines They denied all — They said that they did not recommend any alternative treatments And so, this was very problematic And we do have patients who are paying for things out of pocket

Because of the fact that research has not been done, they have been forced to use these things without research being done So, why wouldn’t we want some research to be done in that particular area The impact on patients, not just pathogenesis, and so on and so forth, but the impact on patients in general of these And we’re not saying what has to be done or particulars of it, but that this is something for down the road based on that this would actually or could actually be helpful to patients So, I do agree that something of this nature should certainly remain in there >> I guess I was questioning the procedural of the inclusion here without further discussion But I’m OK to include some of what you’re saying, be it Dan’s work or anybody else’s work that has already been published as being something that is worthy of further pursuit I certainly think that when we come to the treatment section that there are studies by a couple of groups that suggests there may be other ways to treat this, be it with herbs or antibiotics There are questions of practicality and concentrations, et cetera about that So I guess what I’m questioning is the — where this is included I now understand a little bit, but it seems to me that that previous section was titled Looking Forward And so, it had this commentary from Aucott and whoever else, presumably from — with the agreement of the group I don’t know if they voted on this particular aspect and whether it needs a vote It’s co-chair — >> And just one further — >> — like that >> And I’m trying to find — I found a section called Looking Forward, but it looks like it has mostly quotations from recommendations in the report Maybe colleagues could find the relevant part and share it with us a bit later >> Sounds good to me >> So — >> And share >> Well, that’s what they chose to put in >> Yeah, that’s what they chose to put in So just in summary, Sam, I agree with you, like I was a little bit confused on the looking recommendation section myself I actually didn’t know the Federal Inventory cell in that section Originally, I just thought it was areas that David and I wrote up So I appreciate your need to discern or separate those two categories, the recommendations from federal inventory, and then any additional grouping So just in summary, three areas really, that would be kind of looking forward separate from federal inventory, and that is the potential collaboration improvement for industry, multidisciplinary approach with the inclusion of an oncology example, and then third is a small statement at the bottom, which was what can be learned from something that tick-borne disease could benefit from kind of as lessons learned or best practice from COVID-19 in terms of federal, state, and local reactions And that was just a simple statement I’m not saying that we are calling out any of those things, because it’s a moving target But is there anything that could be learned from it that could be incorporated into the next, you know, Working Group or just looking forward overall, that would benefit patients So it’s really three things And certainly open to cutting down the text, taking out graphics, or whatever everyone is comfortable with overall >> I can just say the Looking Forward sections from the first report, I’m not finding an analogous set of statements >> There isn’t one It’s not the same type of statements That’s why I said that — Because I have the report that I printed out last night to look at it, doesn’t look anything like this report But I knew that they had leeway, but — you know, to do whatever And, you know, we have to decide if that’s the whatever that we want >> I certainly would like more time when you get to your final paragraph

and you say the Working Group urges further consideration of the COVID-19 response, both the successes and lessons learned I need to think about that further before I agree to be included in this statement without looking about it further So I don’t know whether I’m going to request this delay in our approval, or I would this whole area maybe to be a separate section maybe as Dennis said comments from the co-chairs, or let us think about it, or at least I want to have more time to think about this section, and recommend some steps >> So, are there any other comments that were previously included to discuss on the review of this, or anything else now? >> To be clear, Leigh Ann and the rest of the group, what is the proposed path forward with this, with they’re Looking Forward section >> So what we’ve done with the others, people made a motion made motions and there was a vote of the group of what to do And then the writers went back and took that under their consideration and tried to reframe the — it in why to bring forward next time >> There’s also this — This is inserted between the recommendations themselves and some discussion they’re in And then now, we have the subsequent section of recommendations again So this is a bit confusing to me of where this fits And so, it maybe should go near the end, or at the very beginning So — And then we have this remainder here, the recommendations armed with expensive insights >> I agree that putting it in the middle is confusing I agree with that Any suggestion? Just to separate it out as a clear and distinct area? >> If you want to introduce it the way the last group is, you’re welcome to do it at the very beginning And then I, as one, would like to make some recommendations about it for the next step, you know, forward, or at the end But you and David put this in, then you’ve heard several comments and if you can just decide what to do about it >> So we have our individual comments, and definitely need to consider them, but we have not heard from the group as a whole There’s been no motion made in the vote They’re just individual ideas >> Well, it seems to me if no one else is saying anything that everybody agrees that you should move forward and try to restructure this in ways which were stated, otherwise, people would be disagreeing with that And I don’t hear people disagreeing with it And I’m all fine with you going back and redoing, I mean, basically Move what needs to be moved and change what needs to be changed, and see what people think about it >> So the suggestion that this Looking Forward section will be restructured and then resubmitted for review by the membership, or is that what I hear? >> Yea, sure Of course, that’s what Leigh Ann and I will do >> OK >> I mean, that’s our responsibility What I am asking is, I’ve heard a lot from Pat, and a lot from Sam, and I’ve heard nothing much from anyone else I had one comment from Dennis I’m wanting to know, is this the desire of the Working Group? >> Well, in my case, what I understand and looking back,

you are trying to also have a section as he was going in the previous report called Looking Forward But I guess that’s why we are stuck a little bit right on structure and message there, so >> Right >> And based on what you mentioned before, I would be willing, and I welcome the restructuring So I can look at it based on the comments received today on how the message could be clear there in the Looking Forward section >> OK. So I’m going to ask it another way, if there’s anyone that has any concerns, for we spend the time on the rewording and the intake of your comments on the three topic areas, industry, and multidisciplinary approach, and potentially the statement about lessons learned from COVID, although it’s a very small statement, please say so now Otherwise, we’re going to move forward with some of those edits >> So Leigh Ann, in addition to those three main sections, you will also have recommendation? >> Yeah, that would be — what it looks like, we’re going to make that very clear That those recommendations are, you know, obviously, still in this chapter, but very separate and clear So those, recommendations are still listed out as recommendations, but it’s going to be kind of paragraph form, and then the recommendations are in their recommendation bullets, if you will, the way they are written up >> So — >> I’m hearing a desire I’m hearing a desire for that to be very distinct >> Yeah, that’s so — I was going to ask whether the recommendations will there be any supporting paragraphs on the recommendations? Because it sounds like the three things you mentioned industry And the other two aren’t necessarily related to the recommendation >> The recommendations came from the February inventory subcommittee >> Right. So they’re separate from these three things, the COVID, and industry But are we going to have support — supporting text for the recommendations? Are they just going to be stated? And then we have all with the other three things? That’s what I’m confused on >> Well, there is a paragraph below each recommendation >> OK. All right Yeah, I would like — I agree with Beto That, I’d like to see this tightened up Yeah. Reworked Just make clear what the intent is with this chapter >> First of all, these other ones that you’re talking about your three points, they should not be recommendations, they should just be — these are just suggestions for looking forward Not recommendations, because — >> That’s right >> — recommendations went through a whole process >> That’s right >> You know >> You’re right >> That was different issue, if you frame it that way >> That’s right I agree — >> And — >> — we’ll make sure — we try to make sure that’s very clear >> And perhaps the thing with the COVID And I say this, from the perspective of the work we’ve been doing, we’ve even added a section to our website, because so many, there are many people with tick-borne diseases that are developing COVID And I don’t know if there can be something that, you know, shows that, you know, that perhaps that might be lessons learned that, you know, for people who are infected with COVID and with and or, you know, with tick-borne diseases I’m not sure Because it’s not something, you know, that we would usually put in to a report like this But maybe that way, if there’s some way to add that, that that might be something that would be not only more palatable, but more tied to the tick-borne diseases >> I think the point of that is, I might be in the middle of it here There are hundreds of research projects that have been gone and incredible collaborations among people who has never worked together before, and helping people from other universities The actual effort and collaboration is the part that is remarkable >> Yeah >> Yeah >> Hey, David I won’t disagree with that at all

I wish we have had that or had that now with Lyme disease, and we don’t And so, I’m — that is something but when you just say, the COVID, you know, the COVID factor, I’d like to see a little more of how you’re going, you know, put that together I don’t object in principle But I’d first I need to see what kind of language, you know, that comes up I don’t want to be coming on the next time we discuss this and you say, well, and you said you were fine with it? Well, I’m fine with it being looked at and having language, which, you know, we can see, and whether that language seems to fit with our tick-borne disease report So, I don’t have an objection to it, you understand So, I just want to see what’s going to come out of it, and how much of it is related to our tick-borne disease issue >> And — >> Yeah, I’m just listening [Inaudible] That analogy it’s — >> Mm-hmm Go ahead David >> Go ahead >> — it is — the point is, this is an analogy that we could go to develop for tick-borne diseases That’s the point >> OK [inaudible] >> What and I’m looking at the last report, Chapter 8 is looking forward Could we go through that at 8.1, 8.2, 8.3 And these are things that it looks like the whole group discussed And then there was a little bit of text in the beginning of that So this is falling under another assigned topic, isn’t it? >> Right, by stating COVID? >> The talk, the recommendations above this, where it falls this — what I’m saying is looking forward looks like it was the result of group discussion, but then the rest of the prior board? >> Well, look, the way David and I understood this, our assignment was to — and this started, you know, roughly nine months ago, was to take into account some key topics that would be important for looking forward So I mean, we spent months thinking through these topics [inaudible] list So we boiled it down and got down to these And so, we’re fairly adaptable, flexible to how this should proceed But the only thing I was surprised by is I actually didn’t know, my misunderstanding, I didn’t know future I didn’t know the federal inventory section actually fell under future topics So I also agree with all of you that that it is confusing that those recommendations come in the same chapter But — >> So — >> — we understood that we are supposed to be putting forward topics for looking forward that can benefit, you know, the report >> Yeah. I see now I’ll see the report then >> Maybe, this is Ben Maybe I could comment on my thoughts on this I remember, last iteration, what we — the way I recall that looking forward was developed When we were going through the different sections of the report, there was some things that we decided to table that we just said that they just went beyond where we could with the report That we were — There was already too much ground to cover And so, we said we just want to make sure that we make note of this And so that it gets covered in the next report And so, that was the inception of looking forward section And then the other thing that’s different between last time and this time, is the federal inventory piece just didn’t get done in time, for the last iteration, because it was so compressed, you know, we had all the work to do and half the length of time If you remember, and so the inventory just didn’t get included at all So this year, in this report this iteration, you know, we — it would have been appropriate to have a whole section just on the federal inventory that accommodated this recommendation And understand what’s going on here We decided instead of writing to just to combine them all and put them together, and maybe add a little bit to that So I get that I don’t have a major problem with it at all I think, you know, you could have done it Just have a whole section just on inventory recommendations, have a chapter on that And then a small section on looking forward But I think that’s what we’re discussing and debating here And that’s the difference between last iteration and this iteration >> Yeah, I think we can graphically treat it with our expert team, where — and with the correct wording and messaging, where it’s very rare

that to address the concerns that we have all these recommendations tied to federal inventory And then whether it’s in the front, or whether it’s in the back, we have, you know, three bullets, or three paragraphs, or however, or three topics I should say, that are commentary, or editorial, or whatever it is that are looking forward And it will bring that to you as a proposition And we can see where you land next time But we’ll work hard on taking in all of the comments that you’ve provided >> And Ben is correct I was thinking the same thing I noticed that the prior reports had no benefit of real inventories or to act on So the — it was all drawn from the above comments in the report The inventory does provide a really good view of missing thing And so, it makes sense to have the looking forward follow that, as long as it’s clearly delineated, separated >> Ben, this is Beto I think, after hearing all everybody’s comments, I think we are in start to say that we agree that we need to do this section with how we structure that’s another question But I think David and Leanne have a good input from the group today And, again, it’s just a reflection of how our — or this reflects evolution from what was on before and also taking into consideration and lessons learned from the COVID-19 pandemic has been significant And so, Pat’s comments, and David’s comments are, I think two branches of the same tree, you know, how — what we can learn in terms of synergies, in terms of research, but also consider how COVID-19 may be impacting patients that are already suffering from tick-borne diseases And I don’t know how much research has been done in that regard >> Thank you, Beto Are we ready to move on? Is it possible? We only look to be about a half hour behind Am I correct? Do we have any further comments on this section? And if that’s the case, can we — >> Leigh, I’m sorry, I just wanted to ask Ben because I actually made comments in other segments, which you’ll see when we go over them about — >> Yeah >> — this federal inventory And about it having where is the federal inventory section? And we never had one And so, like he pointed out, obviously, with this year, we have the opportunity So what would be the problem and has Ben, maybe I don’t know if he was suggesting? And I don’t think it’s a bad idea? Why can’t we just have a separate chapter for the federal inventory ones, and then the looking forward would consist of the suggestions that you have made if the board, you know, then agrees with them? >> I think that’s a good idea >> I think that solves people’s concerns about it And it’s not in there And yes, maybe, you know, you have to add another, you know, chapter but it really should be in there anyway And so, as a separate chapter, and that would be — I think that would resolve a good percent of this anyway, might not resolve all of it, but it would resolve a good percent >> So it could be included either in the background or in a summary, conclusion section to further emphasize the importance of the work And I know the spirit booted in looking forward to additional recommendations, but technically from the federal inventory So maybe you can think about that and restructure it somewhere >> But, so, Jennifer, are you able to comment? What is — are we able to include a separate chapter, and whether it’s entitled federal inventory? Or it’s entitled something else that is based on federal inventory? Can you comment whether we can do that? >>Sure, you can do that We just need to know what titles you want and then work on separate faster >> OK >> Let’s work on that And Leigh, don’t you think it’s time to go for lunch? >> OK. So can we reconvene at 1:00? >> I can

>> Yes >> Is that OK with everybody? >> Yep >> OK. All right We’ll be back at 1:00 Thank you, everybody [Inaudible] >> Yeah, as say >> [Inaudible] sir Yes, sir. At 1:00 Eastern Thank you >> On behalf of Kaye Hayes and myself is the [inaudible] center officers, I’d like to open up the afternoon session of the tick-borne disease working group meeting With that, I will start out with an invent — a roll call Please indicate when to announce your name is being present We’ll start out with the co-chairs Dave Walker? >> Present >> Leigh Ann Soltysiak? >> Present >> Ben Beard? Ben Beard? >> I’m here >> Thank you >> Scott Cooper? Scott Cooper? Moving on to Scott Commins? Scott Commins? Next Angel Davey? >> I’m here >> Dennis Dixon? >> Present >> Sam Donta? Sam Donta? Todd Myers? Beto Perez de Leon? >> Present >> Kevin Macaluso? >> Present >> Eugene Shapiro? >> Present >> Pat Smith? >> Present >> Leith States? >> Present >> OK, going back as I announced a couple people that didn’t indicate as they were available If you’ve now joined, please indicate >> Hi, Jim, it’s Scott Cooper >> Thank you, Scott OK, we do have a quorum, so we proceed with the meeting, please I’ll turn it over to David and Leigh Ann Thank you >> And now, we’re moving into the Chapter 1 background >> Sorry, David, we’re going to — we have a few comments left on the looking forward section that we need to address >> OK >> It looks like they’re under the recommendation section And I think the cursor is indicating where we need to start >> Yes, so we have an incomplete sentence here, which has been pointed out by Angel Attention of all tick-borne diseases by the best public health what happened namely a vaccine This means you need a verb Is the best preventive medicine — preventive method? For infectious disease OK, the next one says does it make sense to suggest that a single vaccine would convert protection against bacterial parasitic and viral pathogens? And that is the best way if we could be developed to get something that we taken up? Because the — they’re all threats And they are all threats that some of them come together And to get a manufacturer, one of the motivations for manufacturer to make the vaccine is that they would sell enough the product to make it worth their while And so, that would be a possibility But that’s certainly not necessarily what would happen, it says And then there’s a lot of interest among vector biologists in making an anti-tick vaccine, which blocks tick feeding

And these are — this is an approach or some approaches that would be possible Is there an opinion? Is it as to whether that’s inappropriate or sort of its possibilities and gets an openness of mind of the person that might read it? >> I just simply didn’t know David, if that was even feasible I understand the vaccines against the ticks themselves that it is one of the reasons [inaudible] because — >> Yeah. This is Beto It’s feasible Yes >> OK. Thank you >> So, David, are you just taking out the anti-tick-borne disease vaccine or and just want to say the development of an anti-tick feeding [inaudible] that I’m saying — >> No, I’m not I’m not proposing to change it Yeah, I just — I wanted to say that we did protection against the tick itself, just the way to say it, unless you will have a different proposal >> Hi. This is [inaudible] Since you want to start, the only — I agree with the statement of the [inaudible] variation, since you ask, I’m just going to say it But — this is the order that I have The other thing — they’re looking forward, right? [inaudible]? >> Here it is >> What page are we in? Yeah, so just to — >> Ninety-seven >> Yeah, thank you And so, at the end, after the comma, the last comma, and protection against the tick itself to prevent pathogen transmission, but anyways, that was just my only comment, you know, but I agree with your statement Yeah >> So we’ll take note of that Jennifer will consider it >> Thank you >> So the next we have to do — next one has to do with the recommendation itself, so we cannot change that And then with the next paragraph change — so, I will suggest that we need more field studies to better understand the biology and ecology of ticks, and how we might control them >> And that’s a good point, Dave And actually, regarding that, and sorry, I agree with that But if we can also consider something along those lines for recommendation 9.2 where it says the Department of Defense supports activities relevant to tick-borne diseases such as active surveillance of infectious diseases in military personnel around the world, and of the presence, and geographic distribution of human pathogen, and the control of pigs, to which service members may be exposed To the — to your point here in the other one, where take control should be an important aspect of research efforts Because I think that is missing you know And if I need to repeat that, Jennifer, let me know >> Yeah, Ben, you can repeat it >> OK. So, I mean the recommendation, on Page 6, recommendation 9.2 The Department of Defense supports activities relevant to tick-borne diseases such as active surveillance of infectious diseases in military personnel around the world, and of the presence, and geographic distribution of human pathogens, and the control of ticks to which service members may be exposed >> I probably can’t change recommendations >> This is the recommendations in bold and this is the supporting statement >> OK. All right >> So, Jennifer you suggested the change of preposition in to [inaudible] >> Thank you

>> Moving down Keep going So — So, the recommendation here is to increase the funding to studying Lyme disease and other tick-borne diseases And it — that that’s what was voted on I was — what was proposed and voted on And so, to suggest we need more field studies to better understand the biology of ticks and have been shown proposed by Jim This is Jim other recommendations, another recommendation in the — and probably there, you know, at least one other place in the report, and maybe twice I know that tick-borne diseases focused on that And surveillance focuses on that Jim, does that satisfy you, or do you wish to throw some change there? >> It just seems to me it would be good to add just, I mean, I don’t I’m not talking about a long passage But I think it would be worth adding here This is kind of a summary chapter going forward And, you know, a lot of — and a lot of stuff in this chapter is covered in other places >> Now, this came from the federal inventory subcommittee, and after going through all — the all that all pages, that huge federal inventory, discussion among the subcommittee was that they really was proposing NIH funds more research on Lyme disease and other tick-borne diseases And that’s — it — that’s the genesis of this and why it really doesn’t have a lot more details Or it doesn’t have more details I didn’t know why They just didn’t >> You know better the family, I just thought we should add that biology and ecology of ticks is also underfunded and understudied >> That’s true But that was not really the intent of the person who proposed this, and we voted on >> Do you have a change you’d like to propose Jim? >> Yeah, I would just add And I would add in here, something about — >> OK. Point out what you would add and where you add it? >> OK. Let’s see, I would say that we also need at the end, you could put it at the end, we also need to better understand the biology and ecology of ticks and how we might control them? How about that? >> Excuse me, but where — why are we adding this in here? This is from the inventory committee, and this was our recommendation And it was approved And so, I don’t understand why we’re adding something totally different now, under the rationale for this >> When I read this, it talks about the tick polio And it was my suggestion to add this That’s all There’s nothing complicated about it >> OK. But can you — >> They answered, it seems like — it seems that it’s simple >> Well, actually, it isn’t, because these were based on the inventory results And since, that did not come out of the inventory results And so, we don’t have it there because it wasn’t apparently, the committee did not agree that that was something in the inventory results We looked at all the inventories and what kinds of things were, you know, funded and that some of them had levels of funding There’s some were very detailed, some were less detailed

And that’s where this came from And so, you can’t just arbitrarily add something in without having something from the inventory >> The approved action on this, they’re not point [inaudible] because this is already been discussed and voted, and it’s pretty directive and clear cut The studies are suggesting, as we’ve had recent announcements that are moving more aggressively into that area anyway So I think it’s actually a moot point But I think it’s that — >> OK, fine >> — other things should be added >> Thanks >> OK. Now, moving to the next Comment by Angel — >> Hi, David Can I interrupt — >> Yes >> — I’m sorry It’s just an FYI I just wanted folks to be aware of that the tick-borne disease research program at CDMRP, we do have several focus areas that are geared toward this area I was just bringing it to your attention It’s nothing that needs to be changed >> OK. Thank you, Angel, this — >> Yep >> — that’s helpful So moving down to same point to understand the cause of tick-borne disease is to implement pilot projects to assess the effects of clinical and public health interventions and to identify factors leading to the best clinical outcomes So it says in addition, from David’s, and I did not remember adding this sentence So I’m not sure that it’s in there And I don’t know whether — so this should be pertaining to the recommendation above And just talk about reimbursement costs, diagnosis, and treatment So it does fit But I don’t know what is there a query about this, I guess, maybe Pat has a query? >> Now, if there was an addition that came from that needs to be added So this is here So the question is, does it stay or does it go? >> OK. So what’s the theme about this? If this is worth having there to support the recommendation or not? Hearing no overwhelming opposition, let’s move on >> David, can you hear me? >> Yes >> Yeah >> Yeah, I don’t know why my mic was removed I was muted some way I need to go back to 9.3 and 9.5, if you don’t mind >> Could we finish that last one? I’m sorry I was not clear on the — before you, Sam, before they do that I was not clear on what was decided about that last sentence, last sentence >> Well, we had a period for anyone to give their opinion And we waited and had several moments of silence And then we moved on >> Well, I — sorry, but I did not feel that that was several minutes of silence And I heard you say something, David in response, but I did not know what you said And so, I need to know the resolution of that statement Is that statement remaining? >> Yes >> And so, the — it is important statement is staying in there Is that true? >> Yes >> Thank you >> So could we go back — >> Because I’m — >> — at 9.3, please The recommendation is that if CDC presented on treatment guidelines, that include guidelines of persistent Lyme disease And then if you can that recommendation when it says that there is a desire among some of the tick-borne disease working group members, that if guidelines are posted, there should be a guideline on it I think the — it’s reiterating it So I don’t know what more you can say

But I don’t like the idea that there appears to be a weakening in the language I don’t know who said that I certainly did not say that There is a desire among some of the tick-borne disease working group members I think the — this was passed by the tick-borne working members So I like the idea that there is a desire The tick-borne disease working group members voted that if guidelines are posted, they should address both acute and chronic illness or some things but I don’t like the statement There is a desire among some of the tick-borne disease working group >> OK >> And out of five I’m happy to try and modify as presented >> OK. But — So, send that to me and make this >> OK, I can do? And then 9.5, please >> Oh, wait a second, excuse me, that was voted on by our committee, right? And it was voted on by the working group >> Right, the recommendation stands, but I didn’t like the description passed >> Well, why wouldn’t it be that if the working group voted on it? Why would it not be the desire of? So what would you like to say? Nothing would say basically, then? >> Well, you know, it just sounded to me, desire amongst some of the members, it was like, this was an easy thing And — >> Oh, I see what you’re saying >> Yeah >> Well, maybe could some other, you know, sentence be put in there to support that otherwise, we have nothing there to support that? >> Jim, you’re going to send something to me? OK >> Yeah. Let me do that >> OK. That’s fine Thank you >> It’s 9.5 >> David just call back up for one moment, please Is it appropriate in 9.3? In the recommendation, I’m not suggesting a change the recommendation, I’m just asking, is it appropriate that the word if is capitalized? >> Oh, it doesn’t matter I mean, it’s — it is capitalized because it was — there was — the statement it’s — that just maybe they say we’re not going to have any, I think we could make that lowercase, we’ll be just fine >> Well, the only thing with that David, I would say is the word if was capitalized for a specific reason And that was to call out the fact if they post any there, that, there’s quite a discussion about whether or not they don’t already have posted guidelines And so, if was meant to emphasize that >> Yeah. It’s just a fact But we can move on Thanks >> Under 9.5 The — OK The — I don’t know who did this to a paragraph but I suspect changing it in the paragraph >> I think that the phrase in the sentence, it is done to the — so you have ever really referring to body or that If a small quantity of organisms or antigen and expect be removed, they have no idea of the quantity of [inaudible] Again, but presentations can be a brilliant absorber in the body or if it’s Borrelia If Borrelia burgdorferi, it’s playing a role in patient symptoms So it is unclear if the patient’s continued to have Borrelia burgdorferi and that they are playing any role in patient symptoms would be more appropriate That is my suggestion >> So that’s fine with me [inaudible] I think that’s — >> And I cannot have —

>> The question really remains the same So it’s fine >> And the other because the last sentence it under mechanism on the illness In order to develop therapeutic requirement beyond repeated law enforcement We — that’s part is I think [inaudible] to certainly, I don’t agree that that should be there We don’t know whether longer technically, even though there are many of us who think that longer courses of particular antibiotics are helpful But I think that making a statement that has not been looked at when there have been trials of longer courses of antibiotics I [inaudible] >> And I think that’s — I think you’re missing the point The point is that we need to look beyond antibiotics We need to look for mechanisms that are going on In addition to the idea of killing bacteria, we needed to looking at mechanisms and chains of events, because the — and could be intervened in to relieve the symptoms And I think it’s looking beyond antibiotics And — >> Well that, you don’t know that David, you don’t know that You haven’t had experience with it And not beyond Beyond is too strong of a word It’s not tested And I hope to test that Maybe you want to say in addition to — >> It means in addition to Beyond means in addition to >> Well then remove that sentence >> No >> We certainly need to understand the mechanism of chronic illness That’s it You’re developing therapeutic countermeasures against antibiotic treatment And I certainly don’t agree with that I — >> No. It’s not — it’s beyond antibiotic treatment I’m trying to find out what are the mechanisms that are making these people sick? And what their countermeasures could attack those mechanisms? That’s what’s been neglected >> Well, it maybe — mechanism there, OK But this sentence really implies that longer force of antibiotics is inappropriate We don’t know that >> It doesn’t say that It says you need to look beyond that You need to look at other possibilities >> Well, I guess I don’t agree with the — with how the sentence is created I don’t know if anybody else agrees on that? >> I support David’s thoughts [inaudible] like I don’t think he’s condemning what’s been done in the past I think he’s saying why don’t we look at other explanations, signs and symptoms? And who’s going to argue with it if it works? So I think it’s looking at some of the other things that have been hypothesized and not adequately studied >> My — why don’t you — that account on this and leave the antibiotic issue out You’re putting an issue, and it’s not necessary to be in there If you want to and understand the mechanisms, you want to understand the mechanisms And you don’t need to say beyond repeated courses of antibiotics, because that clearly is an anti-antibiotic statement >> No, it’s just saying we don’t need to stop with saying let’s give them antibiotics They need to go further down the road and look at other possibilities, as well >> Well, how about then let’s changed the word beyond to in addition to? >> Yeah, that’d be OK >> Then [inaudible] about that >> I’m OK with that But also implying the repeated longer courses of antibiotics is appropriate But — and I guess, OK, that’s good That’s fine I’m OK with that Thank you >> And maybe it should just be an addition to antibiotics? >> Yes, I think that’s right >> That takes it out in addition to antibiotics I’m good. How about instead of things to countermeasure, let’s say therapeutic measure? >> No, no, no, no Countermeasure means you’re going to block the pathogenesis and it’s not just simply smashing the bacterium It’s understanding whatever it is, that’s gone awry That needs intervention And intervention is a countermeasure that’s really a point towards understanding the

pathogenesis, which I think is what’s missing >> The only thing with that David is you may be the only one who interprets that Is that right? >> We we’re — >> Yeah. Being of the incredible story that you have, and just putting ourselves back into the seat of the reader, are they really going to understand it the way you just interpret with that? >> I think Congress will, because BARDA and NIH use that word for drugs, diagnostics, and therapeutics So it has a very broad, encompassing suggestion that should be favorable to people on this committee >> And that was the whole purpose man, $105 million grant, I had to develop countermeasures against [inaudible] I mean, countermeasures — >> OK >> — countermeasures, countermeasures >> All right >> You’re right Leigh Ann of this jargon, but I’m frustrated that how the dictionary continues to add things that people just use the way [inaudible] >> OK. Now, we should move >> Yes. We can move Are there more comments in the section? No. OK. So moving to the next section, background — I think background chapter Leigh Ann, do you want to lead this one? Are you going to pass on to me? >> I think we need to divide and conquer >> Yes >> And if you want to start, all right Let start whatever you prefer, David >> OK. So the first comments from Ben Beard He said, concern is a better word, not every tick-borne disease, and it says public health epidemic Diseases transmitted ticks are sick, serious and growing public health epidemic And as an epidemiologist, he’s going to tell us exactly what epidemic means And I think that’s a good thing It means a significantly higher number of cases than a normal background based on baseline level And tick-borne, most tick-borne diseases are endemic or constantly hyperendemic Endemic means, like they’re in nature, and just they’re all the time and they’re going to have to remain there, but not epidemic And so — And, again, there’s got to comment specific diseases transmitted are epidemic remain of serious concern So epidemic seems to be a metaphor — >> If I — >> — we’re all wanting to use different ways >> My question there was Ben, did Lyme not fall into epidemic where the others we’re certainly not there yet >> No. I mean, you know, when we use the term epidemic, we mean, a significant temporal or spatial increase over the baseline And just like David explained And so, a disease like Lyme disease, I would say is hyperendemic I mean, we have more every year is always bad, and it’s getting worse and worse And to me, it’s a huge concern And I’m not trying to downplay it It’s just in my mind is not the definition of an epidemic We have — when we have — >> Thank you That the thing there >> — epidemic years Yeah, that’s all >> Thank you >> I’m sorry, seems to be more attention-grabbing term anyway >> So, Ben, I need to know, I don’t understand that why Lyme is — I understand the use of the word concern in the sentence I agreed with that, because not all tick-borne diseases are I do not see, I do not understand why Lyme isn’t And so provide several examples of diseases that are considered epidemic >> Well, I mean, clearly, COVID is an epidemic and it’s a pandemic because it’s an epidemic that occurs on multiple continents and we’ve not seen it before It’s been here since February, it’s a huge among coronaviruses It’s an epidemic because it’s a huge increase above the baseline I think that, you know, we see epidemics or outbreaks of Eastern equine encephalitis that occur seasonally They’re — they’re different from year to year Same way, West Nile, if you think of the West Nile occurring in certain areas, we can have epidemic since some parts of the country

and different parts of the country different times And again, it’s not my goal — it’s not my point to downplay the importance of Lyme but to me, Lyme is not an epidemic, because it’s bad every year all the time, it’s getting worse and worse and so it’s not the strict — my understanding, the strict definition we use in epidemic is a huge, huge public health concern I would say it that way But, you know, I’m not going to split hairs over it, it’s just sort of an editorial comment I make and, you know, the whole thing may be lost on people that are not, you know, in Congress, I’m sure they like that but, you know, they would make a distinction there but — So, I won’t die on that Lyme >> So, I do it — like I say, I didn’t disagree My comment there says, public health concern, and that’s fine by me But I am sorry, I have difficulty I hear what you’re saying So you would — I think what you’re saying is for a disease to be epidemic, then in other words, just because we’re having more cases year after year after year, that’s not an epidemic And we have a huge number of cases, but that’s not epidemic >> Right, I mean, we usually describe it like two, two and a half times higher than the baseline to be — and every year, you know, that’s you know like a — you know, I can’t explain it better, maybe someone else would like to, but — >> I know, I mean like think about Zika There was a big epidemic of Zika virus in, you know, Puerto Rico and — or, you know, some other areas, because there was very little and all of a sudden there’s a lot That it’s a marked increase over expected Lyme disease is common and there’s a lot of it every year, and it’s incrementally going up every year But it’s — and as Ben says, it hasn’t gone up by three fold all of a sudden in one year, that would be an epidemic >> I say I think — Thank you >> So, I think that we’ve dealt with that And I believe that I understand that we’re going to be happy — have concern And that’s — and it’s — that actually deals with disease is transmitted by ticks The next statement I see is — where it says Rocky Mountain spotted fever is fatal and she say can be fatal I agree with that And we’ve actually be changed And then it says babesiosis should be mentioned in this list >> David, I withdraw that comment I’m sorry Because I looked at it and I realized that they were talking about current — currently things in the last couple of decades that were coming on board And Babesia obviously has been around a very long time, so >> Yeah, it’s in the table >> I — yeah, I know But it was — I was looking for the sentence in the background, but I withdraw it because it doesn’t fit the category that was mentioned there >> OK, we’re moving on down So — >> Two o’clock >> And this, yes, there’s a table and, yes, the alpha-gal syndrome is a condition rather than a disease, you know, and maybe — >> Hey, David I’m sorry — sorry to interrupt you, but at the end of the first paragraph, I would like to check with the group My comment is, in the last sentence, it says table x. I would suggest that we say table x lists, tick-borne diseases and conditions recognized in the United States I don’t think it’s proper to say that it’s a complete list Because as we know, we are — we continue to discover new tick-borne pathogen, so >> I agree I agree >> That would be my suggestion, you know Table x lists, tick-borne diseases and conditions recognized in the United States >> That’s a good change >> Also in that table, I agree with his change But in the table I noticed that the pathogens for Babesiosis divergens and MO-1 are not included

And even though I know divergens is a primary strain in Europe, but apparently from the literature I’ve read, it is certainly also in the United States And MO-1 is an unnamed, so they’ve given it that designation for I guess Missouri 1 And I think that [inaudible] is — they are producing disease in the US >> And I agree, and further, and again, that this is just my comment, whether we include this or not in the sentence for describing table x is that we’re saying diseases and conditions Should we say of public health importance [inaudible], or of one health importance because as we know most of these are circulating already in the environment, maintaining in wildlife or even domestic animals and they jump into humans >> No. Beto, I don’t believe this is the time to introduce that concept This is a back — and really supposed to be a broad strokes background >> OK. All right >> And this table is an exception, and it’s a good exception because it puts all of the cards on the table But I don’t think we want to get into details like that in this background chapter, which is supposed to be broad strokes And it is as it stands now >> OK >> And somebody, maybe somebody answer this question for me I see Borrelia mayonii is listed as an etiologic agent of Lyme disease Is that right? >> Yes, it is, of Lyme [inaudible], yeah >> OK >> Yeah >> We’ll see in the Northern Midwest >> I know that it causes disease I didn’t know it was cause — cause the Lyme disease And you know now — >> Yeah >> And I just want to make sure we captured under babesia parasite, did we capture the other pathogen that was mentioned a moment ago? >> Babesia divergens >> And MO-1 >> OK. Thank you >> We move to the next comment So Ben is asking, you know, what other vectors has alpha-gal been associated with? And I don’t know the data on that and I thought that they were — >> I wasn’t aware but it — >> — Europe and in other places >> Yes. I’m aware that it’s associated with several different tick species, but I’ve never heard of alpha-gal classically being associated with other vectors besides ticks >> Yeah, we put that in our report, the alpha-gal syndrome report Scott? >> Scott had a clinical emergency He’s not on >> OK, Angel Do you recall the ones that — we can circle back, but we did allude to other vectors other than lone star >> But she is asking are there other arthropods besides ticks I mean, like flies or sand flies or fleas? >> Well, we — that’s why I’m commenting is that it wasn’t — I don’t have the exact text in front of us But it wasn’t completely ruled out So Angel, do you remember exactly the training? >> I don’t and I’m trying to look it up right now >> But it wasn’t completely ruled out is my recollection So we can circle back just to complete that area >> OK. Moving down >> Just a second, on under the table, it says source the table in that listing But that table does not include what you just added to the table So is that OK? Or you’ve added a couple more pathogens that are not? >> That’s a good point We can add a couple different sources in support of it, we’ll build on it >> Just put modified in the sources to [inaudible] >> Yeah >> But you can just say derive from tables >> Right. That’s right >> Leigh Ann, this is Angel It was the chigger bites that were — >> Yeah >> — some literature that referenced chigger bites as a possible vector that might initiate that IgE response >> Yeah, thank you So we can get that source >> Yeah. OK

All right Chiggers and ticks are, yeah, I won’t get into the taxonomy on those so people can [inaudible] are I don’t know if Kevin or someone wants to comment on that >> Well, and just kind of thinking chiggers, don’t they feed more a little bit on saliva secretion going in just digesting right there in the epidermis, not really the blood feeding So there’s some different biology there I haven’t read that paper if the chiggers were involved in this and possibly [inaudible] get this >> Well, I’m actually familiar with that because we have a [inaudible] Scott on this looking at risk factors And the thing is, in some cases, people have said chiggers, and we don’t know if they really mean chiggers or seed ticks or larval ticks And, you know, that would be difficult for a non-expert to identify those But if you’re referring to chiggers, I would just say maybe caused by chiggers or ticks You know, I wouldn’t say other vectors, because other vectors that really — that opens the door in my mind way, way, way beyond where we think it is >> OK >> And then based on what David said before, I mean, it depends on whether it’s a cause or an association, because it’s known that the patients with alpha-gal allergy are more likely to be allergic to insects as well,so But with that it is — yeah >> Which is the other thing, we don’t really know that it’s caused by either of these We know that it’s associated with, but the case control studies haven’t been done to show causality and the tools that are in place you have to do that So maybe it’s better just to say the list alpha-gal syndrome is a condition and note that it has been associated with ticks and chiggers >> Yeah, I agree with that >> OK, moving along, the next figure shows a general concept that tick-borne diseases are on the increase I think that demonstrates it very well, let’s see It is the CDC is the main primary source of the data What do you want there, Ben? >> Well, it’s just that the symbol there says screenshot from niaid.nih.gov and this is actually a CDC graph And it’s a — and so, if you’re going to probably should cite it that way rather than, you know, NIH, right? >> OK, it will be done OK, moving down to the next one, the path >> Also, the word screenshot from here doesn’t sound professional, seems that were — >> Sorry, that’s going to be cited And the next is that — comment for Pat, that one tick bite can result in more than one disease being transmitted >> Yeah, I thought that this should be a little more of a clarification We do say that patients can have simultaneous infections of two or more tick-borne pathogens, a condition called co-infection But we don’t really state that, you know, one tick bite can cause more than one disease And I think that’s important to put in there >> Thanks, a good point >> Actually, anybody is exposed to one tick bite probably is going to be exposed to more than one tick bite too >> Yes, that too, but at least it’s — if people know because right now, they don’t know that They don’t — They understand that they can get other tick-borne diseases, but they don’t necessarily know that they can get them from that same tick bite So I think it’s important to make that distinction, yeah >> That’s a good point, I agree >> Seems like it really says it there in the sentence, so complications arise when you have simultaneous infections, two or more tick-borne pathogens called co-infection And then what’s missing? >> Well, I just think the way she’s stating it is just kind of more simplistically about the tick bite itself >> But what if you add at the end which can result from

>> What I have in there is, you know — and this can be added wherever you think it’s appropriate One tick bite can result in more than one disease being transmitted For example, that your tick can transmit Babesia, anaplasma, Ehrlichia, and Powassan virus among other organisms, depending on where you live I mean, you can take out that last part or not, but that was the way I thought about it >> I’d say one pathogen, more than one path be transmitted >> Diseases aren’t transmitted, pathogens are >> Right >> Yes. Move on >> OK, moving down [Inaudible] talked about the 21st century [inaudible], requires US Department of Health and Human Services Secretary to establish a Federal Advisory Committee And so because it’s the fact that we are working group, I don’t know what they got that we were supposed to be called But we are calling the working group >> Yeah. And it states that I believe in the legislation, their working groups are lumped by HHS under, you know, advisory committees, but I thought to be true to the legislation That’s what it is >> OK And Leigh Ann is sorting here, industry representative recovered patient >> Yeah, Jennifer, are you going to make the font any bigger? I’m sorry, I still struggle with the size >> So you can also change your screen by — on the Adobe Connect, you can do full size, and then it blows it up to the size of your computer screen >> On, are you on to this one with where Leigh Ann comments? >> Yes >> OK. Leigh Ann, do you have a comment? Because I want to make a comment >> No, you can make a comment >> OK. I think that we need to remove three representatives because, again, the legislation does not consider that a category And so on someone down the road to say that there’s a precedent been set, it says in here that there’s an industry representative You may represent industry but I don’t think you’re representing industry sitting on the working group per se >> Is that not in the objective definition? >> I have to work — I have the legislation right here There have been nonfederal public members and representatives of the following categories, physicians and other medical providers, blah, blah, blah, blah Scientists or researchers with expertise, patients and their family members, nonprofit organizations that advocate for patients with respect to tick-borne diseases >> Leigh Ann, that’s correct >> Oh, yeah Yeah, the — >> OK >> He is a recovered patient slash industry representative, whether it’s part of the legislation or not >> I know and I’ve been listed as an industry representative from [inaudible] >> Yeah, well, because you put it in there But the point being is it’s not a legislative category And these are the members of the nonpublic, so that has to be removed It’s not — that’s not a category of people that sit on there It doesn’t take away your job, it just takes away the descriptor with this working group >> Can we say private sector? >> No, I don’t put this up, not a category I think maybe what we could say is, we can say seven are public voting members and seven are federal members and the public members

So still the, you know, the working group requirements for public members or something like that And we don’t have to delineate >> No, I think it’s good to have what — this is trying to explain to the readers of the report who generated it I think signing include scientists or clinical researchers, physicians, patient, patient advocate, I think that’s essential >> OK >> And I’m trying to understand what the issue is, is like defining me as I am Like what’s the issue with having me listed as an industry representative? >> Because — >> If I could — >> An industry representative >> [Inaudible] history will — itself and next working group, they’re going to say, oh, well, we can have an industry representative sit on there, because we had one last time even though it wasn’t in the legislation And so you can’t be categorized If you want to say, recovered patient, that’s fine, as far as I’m concerned But I don’t think you can say an industry representative, you’re not representing industry there >> Well, I wouldn’t know why you wouldn’t want an industry representative Given that, I’m going to talk about the necessity for collaboration >> Yes, and I’m talking about the legislation, enabling legislation >> It doesn’t meet the statutory requirements They would have been industry representative and they wanted that as a category, so >> If you put both, could you say an industry representative who is also a patient? >> Not represent an issue because you can [inaudible] >> No, because that is why she is representative >> Yeah >> She’s listed as an industry representative as part of the air in the working group But Pat is right here, the technical thing, if you’re going to say who the members are, then you have to say, according to the wording of the act, and the act does not have an industry representative in this for better or for worse We all appreciate your presence, including your industry experience But think — that that go elsewhere and it is in your resume So I think that has to be stricken because that was the description >> I’m just not sure I agree with that >> What about a patient representative who is also from industry? >> So then we’re singling her out What about if we want to say then about the scientists and who they are and the doctors and where they’re, you know, from? That singling her out as you know, and it’s not in the category >> I think this is a technicality where it needs to weigh in Jim >> Yeah, Beto, thanks This is Jim Yeah. I think we need to stick to what we get CARES Act, that is identifying as members And it does not indicate anywhere in an industry representative It has the positions that Pat state — stated and that’s because we should stick with >> Thank you >> The other part is I don’t think the public members exclude there being more than one patient advocate It says here and a patient advocate So and patient advocate, I think would still be — >> No, she’s a patient She wouldn’t be a patient advocate, she doesn’t have a group >> OK >> I mean that — and not that I know about >> So, is there — should there — that the list that you are a patient advocate and separately a patient or? >> Yeah, you can be a patient or a family member For example, I could be listed as a family member of patient You can be a patient, you can be a family member of patient or an advocate >> So you can have both on the list Patient and patient — >> Yeah, yeah, there’s no — there’s not restrictions on the numbers And, you know, though, actually, I know the intent was to have more patient representatives or advocates But it doesn’t say the numbers so — >> So if you’re listing me as a patient, I need to be categorized as a recovered patient? >> You can be actually — >> If I may? >> Yeah >> I don’t you know, I don’t know that that status means, you know >> No, it doesn’t say recovered patients in the — >> Well, that’s what she is We’re missing what we have on the — as public members this cycle >> Yeah, that’s it

>> Then just patient >> I have an issue with being listed as a patient >> Well, maybe you shouldn’t have gotten on board then? >> No, the [inaudible] No, the problem is, is if I’m listed as a patient, I can’t be employed, so >> Well, you — what? >> I — >> Explain to your employers that patient, I don’t know, does patient have a timeline on it? I mean, you were a Lyme patient >> Well, I don’t find it to be — >> So I’m going to say she’s a recovered patient >> I don’t find it to be a funny matter I need to clearly state that I’m a recovered patient >> What former Lyme patient? >> I think recovered patient is most accurate designation you can get >> How about if, all right, Leigh Ann, what if you put patient and I know this — I still don’t agree with this But what if you put recovered or whatever terminology in parens after that? So the patient part is still there and then recovered is after >> Yes >> And that would be technically more [inaudible] So it does not say that the panel should consist of a patient >> Yes, that’s what I was looking to >> Yes >> As it more addresses and strictly adheres, though, to that >> Leigh Ann, are you OK with it? >> I don’t know, I have to think about it >> OK. Moving down to the next over here [Inaudible] So as she — >> David. Just one — >> — expand and — >> Yeah, David, just one comment before we move on to keep in perspective, because in congressional action at the end of the paragraph is stated, and I just want to highlight that here after working group, because that became a comment in — at the beginning of Chapter 2 So let’s just keep that in mind that thereafter, we are referred to the working group Got it >> Moving down to the section second report focus and structure and Angel has pointed out the word expands and will be [inaudible] to provide clarity, that the intent is not to repeat things already covered in 2018 report But to indicate that the 2018 themes recommendations are very much relevant, important today How would you do that, Angel? >> Well, I think there’s been some discussion as we’ve gone through the different chapters that, you know, wanting to emphasize certain things And it’s brought up that those items were kind of already discussed at length in the 2018 report So I mean, my understanding is that we’re not to be exactly repeating what was already done today I don’t think we should ignore it I thought maybe it would be useful if we explicitly say that here, that way folks are not wondering, well, you know, what happened to this particular item of interest? Why wasn’t it included in 2020 report? So I just thought, it would give — >> So where would you insert the statement and what would it be? >> I have no idea I think it — I don’t want to write a sentence while we’re on the phone It’s a waste of time I mean, I could very easily help edit this, if that’s what we want to do >> OK, which — You’ll send us assignments, OK? >> Yeah, no problem >> Somebody has got their — and there are some noise in the background and are unmuted If they could — how do I mute this one? >> So, David, I can pick it up from here >> Good >> I — when I read the statement, the working group fully supports the initiatives and wrote this report with the intention of building and expanding upon them We can certainly work with this But if — because I didn’t have the background on the first report, I wanted to make sure that there was an understanding that there was already the prior report and this, in fact, is the second report With, you know, there’s a focus and structure on the second report So just by expanding on it, I don’t know that that’s clearly understood There may be folks who have not referenced or even read the first report

So I think there needs to be a clarity that this is the second report, this is the 2020 report There’s some kind of language that’s just making sure that’s being said This, in fact, is a second report >> Well, you could say that working group fully supports these initiatives And the 2020 working group wrote this report with an intention — with the intention >> No, my point is that they may not know if they’ve never been privy to the fact that they just need to understand this is the second report Did we say that prior? I don’t know who said that prior Did we say this is the second report anywhere? >> Yeah, earlier you said that we are spending on the previous >> It’s OK So as long as I said — what was that, Angel? >> I’m sorry, it says this report, the second of three, expands on the recommendation >> OK. Thank you And then the next comment is about these categories or actually the chapters So these are organized according to chapters So the structure is actually referencing the chapters, it’s the chapter titles And if we add another one, that should be included >> Should be one that — >> Well, then you might have to change that in many places So for example, the next, right below those bullet points, it says most sections, which I presume — >> That’s fine >> — would then be changed to most chapters >> OK, as long as we’re consistent That’s fine OK. Next question >> Just saying there may be of — many other places that need to be looked at then >> I agree with that >> And Leigh Ann, you raised a very important point to be consistent, you know, yeah >> OK, next section I’m just scrolling this up Sorry. I’m trying to blow it up, it’s not responding OK, one moment So these comments are from quite a while ago We’re on to the methods of the working group The one thing that I found to be a bit confusing, I don’t know if anyone else did is just the back and forth on the working group language, in the subcommittee language I think, at least where it can be inserted I don’t think there’s any harm in just repeating the Tick-Borne Disease Working Group Because if you’re new to the report, new to reading it, it can at times get confusing to go back and forth into the language of working group and subcommittee If you don’t know what our structure is and what our methods were, when you’re reading subcommittee in a working group, it can become confusing We all know it We all know it and understand it But if you’re again, you’re new, it can become confusing So I think when it’s appropriate to at least restate Tick-Borne Disease Working Group >> Maybe you might want to put in front of subcommittee report, the eight subcommittee reports because that really emphasizes from the beginning what our structure is >> Yeah, I like that, that provides even more clarity >> In my comment I said that this would read — would also, where we have the word this report should say, Tick-Borne Disease Working Group 2020 report >> Yeah. I agree with that I think that even clarifies it more So, thanks, Pat Develop the report, should be trained to develop this Tick-Borne Disease Working Group 2020 report to Congress I agree. I think there’s a subtle change but I think there’s value in stating that So the comment made by Pat below is where the co-chairs on subcommittees Yes, David was on ehrlichiosis and the rickettsial and I was on alpha-gal syndrome

and the the public [inaudible] subcommittee So that should be added or clarified as needed >> I think yeah, I think it should be clarified it, you know, that because certainly most of our groups did not have co-chairs on them And, you know, I’m not sure I just think it needs to be clarified then >> OK. Yeah So that notation will [inaudible] flash point, I believe, I actually left on public comments subcommittee there for myself as well Changes made a while ago OK, did we address this kind of theme about the nonpublic — >> Yeah, that’s fine Yeah >> Well, OK, and moving on below And another comment from Pat [inaudible] after relevant science, add patient needs And I aim to having edit there about practice issues and social needs I think those one — >> Yeah, that is fine by me Yeah >> OK. Pat has another comment I don’t think this adequately We’re down I will catch up with Jennifer as well And you want to speak to that, Pat? >> Sure. I thought that it was not, you know, clearly delineated as to how, what happened And so I have suggested each subcommittee presented a slide presentation with its recommendations and justifications Recommendations were then discussed and often altered by the complete working group, and were then voted upon by the working group That was my — >> Yeah >> — language >> Yeah. And then I just added that I agreed But then I stated each subcommittee — if we wanted further clarification or not depend on how much detail we wanted to get into since this is the method section Each subcommittee reviewed a strong presentation highlighting the reports And then the order of those reports were about all [inaudible] rationale and recommendation As a result, the Tick-Borne Disease Working Group discussed multiple recommendation as necessary and it leads to [inaudible] >> Approve, modify or reject >> I’m sorry, what was that? >> Approve, modifying or rejecting >> This — David, I think you’re going to have to repeat that We didn’t hear you >> We voted to, I’m sorry We voted to — >> Approve, modify or reject >> Approve — right >> Got you Yeah, got you, OK Thank you All right And then we have the — >> And I see there, Leigh Ann is you said, I think this is what you did here You have each subcommittee reviewed a slide presentation When I see that, it makes me think that the subcommittee was going over it themselves rather than presenting it to the working group >> OK, so change and we review to presented OK. Yes, got you Each subcommittee provided a slide presentation highlighting >> Yeah >> Yes, OK Thank you Ben, any comments on your edit here? >> You know, I guess I just wondered what was meant by the statement that NIH and FDA, as well as CDC conduct disease surveillance In such human surveillance, I just wanted to know what was meant because I know that we are charged with disease surveillance that we’ve worked with CSTE on, and I just wanted clarification on that statement >> Well, I don’t think that’s the mission of the NIH and the FDA I’ll [inaudible] the responsibility for human surveillance, and they have other responsibilities >> Well, can we hear from them to hear if they’re involved in that or not? The NIH and FDA representative? >> So Sam had a comment on the subtleties of that

We certainly know the certain wording, so we had a position on that Sam, if you’re not on the phone, can you type your response into the chat box we have? He was having phone troubles Want to hear from FDA while we find Sam’s position? >> I don’t know if Todd is back yet or not He had another meeting he had to go to >> Yeah, I’m back on now >> To start, do you hear me? >> Yes, we can hear you >> Yeah, so I didn’t hear everything but I think you guys are talking about surveillance >> Yup >> Does the FDA do human surveillance for [inaudible], right? >> For tick-borne diseases Yeah >> Right >> I’m sorry Can you guys hear me? >> Yup >> OK. So yeah, you’re talking about surveillance with tick-borne diseases So surveillance, the FDA does not do surveillance >> OK, this is — this is Sam, I heard Ben — I mean, and just talking earlier, and I thought he meant Sam Donta So yeah, we have — we dabble a bit in surveillance on these when we get individual grants on them But we do not have an overall surveillance program It all has to just come from investigator initiated grants that gets reviewed Well, we don’t have much on it We have a little bit but not much >> Is it surveillance research or is it actual surveillance, disease surveillance I am reporting? >> Yeah, it is It’s surveillance research, it would not be average to your typical disease surveillance Here’s a little small kind of localized, you know, this particular military installation or something like that >> And it’s not proactive right, Sam? It’s not proactive like we thought? >> I would say precisely, my understanding would be that CDC and DOD, the human disease surveillance for tick-borne diseases and, you know, I know FDA — I can’t speak for what they might do on drug resistance or anything else or drug use but I would think — and I’m pretty sure, and Angel can comment on this, the DOD has their own independent surveillance system In fact, I know they do because we collaborate with them on things And I would say that NIH conducts surveillance research, but I wouldn’t say that they conduct surveillance, but that — >> I would agree >> — my view on things >> Agreed >> OK Thank you We’re — >> I have — if we’re done on that, I have something right there in the same vein in the same– >> Yup, I was just going to go to that, thank you, go ahed >> OK. The DOD, where it says above it of the working group of NIH — CDC, NIH and DOD have addressed all but access to care CDC, NIH, and DOD each has a strategic plan for addressing tick-borne diseases Well, my knowledge and Angel can correct me you’re — the only one that I know of from our inventory is that the CDMRP research plan, research program, excuse me, has that, but I don’t know that the DOD has a strategic plan overall for addressing tick-borne diseases I have never seen one And Angel maybe you can address that >> That’s a good point, Pat, I’m not aware of that either As you said the only one that I’m aware of is the one from our program >> I’ve looked for it, believe me >> Yeah. So maybe we need to remove DOD from that part Or say that they have the, you know, one for research with their CDMRP program which would be true, but not overall that I — that we know about anyway >> Did I miss you guys?

>> Nope >> Yeah >> You’re there [inaudible] >> OK. Thank you Void — >> OK, so Pat, do you want to comment? >> OK. My next comment was about the — and this is what I alluded to when we were discussing it back in the other chapter Where is the federal inventory subcommittee process? I don’t see that explained here So if we put in a chapter with that, we could explain that process there Correct? >> This is the methods chapter, that would be here >> I’m sorry say that– >> This is the chapter on methods Which the — >> Yes, I’m aware of that >> So it should be in this chapter >> OK >> Yeah, that — >> All right, no problem, as long as it goes somewhere I don’t think I need to address the second part of my thing that was a comment, just so you’re aware of that >> OK, scrolling Scrolling down The question from Pat >> Yeah. My next item was, there was another paragraph in — when this was first put up, which included two bullets And so I don’t know what happened to that paragraph or it disappeared someplace You know, probably >> We can’t hear you, Pat >> Oh, I’m sorry I’m trying to find my paper where I have that on there Yes, anyway, when we — when this was put up, it’s this working group report, it had another two bullets that had two bullets on the end And they seem to no longer be there And I don’t know what happened to them >> OK, what did the bullets say? Yeah, that’s what I’m — sorry I have dozens of papers here with all this And I can’t find that paper that I wrote those bullets on Well — >> OK, can we move forward and then if you find them, we can go back? >> Yes, forward >> OK, so you have the next comment >> OK. Oh, good Here. I just found it anyway OK, here was the missing bullets And it said, based on federal inventory results, the working group identified the following needs and gaps in research First bullet, update efforts on tracking and investigating the prevalence of Lyme and other tick-borne diseases, for example, within VHA, and make the education modules available to practitioners Second bullet, increase NIH funding to support research on Lyme disease, quote — in parens, particularly persistent Lyme disease, end parens, and other tick-borne diseases So that was on the copy of this, and I don’t really know what happened to it Why would — what’s disappeared I see on here the one — the missing bullets that I have from the original report Leigh Ann, you made a comment and you said why is this in the methods section, it is a recommendation I don’t believe it should be in this section Is it voted and agreed upon by the Tick-Borne Disease Working Group? But the other side of the point is we — you put other things in that report and I’m just wondering, I don’t know I’m wondering what happened to that if anything >> Yeah, I can’t answer that I have the same comment below just relative to the public comment section, which was as I went through this overall chapter, my understanding was that I’m a little baffled by us getting into some results I felt like methods should be really only about process

And I added some of that commentary below, which is how come we’re actually doing some reporting on I guess I mentioned it for federal inventories back at — months ago But I also commented on it for the public comment section, that we were actually reporting on what I interpreted as results And I myself didn’t find that to be really appropriate in the methods or what I internalized as process So I went back and looked at the 2018 report And it was similar in that report So I said if I was — it was done that way before, you know, if we want to just keep it that way, that’s fine But personally, I don’t really agree with that I would rather that the results or impact is, you know, embedded in the appropriate sections through recommendations, or as they were internalized, and applied to recommendations and so forth I just felt crystal clear Methods should really just be reporting on Here’s the process we used in X, Y, and Z, and that should be the end of it >> I see. Well, that’s fine But then perhaps this language should have been put in the other area >> But I didn’t remove the language, Pat, if that’s what you’re implying >> Oh, no, hey, I’m not making any implications about that I just know that the language isn’t there I want to know what happened to it I see that you made a comment and you even said, why is this in the methods section So — >> Yeah, I don’t know where that went I would never remove the language >> No, but it happens We all know that SharePoint, in my opinion is not an ideal situation Anyway, my point is perhaps this needs to be put into the other section where, you know, we have the federal inventory, because that’s what it’s out So maybe it needs to be included in that >> Federal inventory has the five recommendations that we voted on in the past >> Yeah, that’s not what this says This says based on federal inventory results, the working group identified the following needs and gaps in research That’s all it says And then it has a summary with the two, two quick bullets on that And since we might be putting in a chapter, perhaps this language might seem to go in that area And maybe you know, it, because it’s, it’s here It was somewhere, and then it wasn’t, and it seems to be logical >> It makes sense, Pat Sounds like something I wrote >> Well, I don’t know who wrote it But we could, I mean, I could certainly send this over, I have the language and the comments that were made, I could send that over to who was doing that, Sam and you or somebody with that particular area, I could send this over for you to look at Since it was language that was in there, but disappeared somehow with the process >> OK >> Is that acceptable or? >> Yes >> OK. I mean, yes to me, I don’t know >> Yeah, let’s — >> I think that’s what this — I think that’s what this meeting today is about, is finding things for us to charge the book chapter writers to consider >> OK. And maybe you’ll look at it and it won’t be able to be fitted in where you put it I don’t know But my point is, it was there and I don’t know who put it there But it was in the original section And I don’t know how it got lost and I’m sure in the process So let’s get — let’s have it looked at where it apparently belongs, which is in the federal inventory And that’s what Leigh Ann had said, and I think it’s — so it needs to be looked at there I’ll happily send that over after the meeting >> Thank you >> OK >> I have a comment Right above there, the last paragraph, it begins with similarly NIH continues And it says to support an extensive research portfolio that are including basic and clinical studies It sounds like it’s already doing this And certainly, there are not a lot of clinical studies, either because they’re not being submitted But I think the implication here is that this is already going on And somebody who reads this might say, well, that’s already doing it We don’t need to do anything else So I think we need to be careful how that’s phrased

>> Well, Sam, we discussed this at the subcommittee meeting And I had done an extensive review of all of the NIH grants, titles and had made this synopsis of the status It doesn’t mean that they shouldn’t do more or couldn’t do more or won’t do more This is just the assessment of what was in the inventory report of what they are doing >> Well, they do include a lot of basic studies, but not a lot of clinical studies >> The portfolio includes some clinical studies It’s an extensive portfolio >> Yeah. And some clinical studies >> Yeah, I have to say, David, when we reviewed this, I do agree with what Sam is saying, the NIH certainly has, you know, a portfolio of studies, but not many of them are devoted to clinical studies And so I’m wondering if there’s some way to rephrase that >> Recent clinical studies to be non-interventional and trials to be interventional So we do have a number of projects looking in humans for various aspects of things that are non-interventional and classified as clinical studies >> And that’s what I saw when I reviewed the portfolio grant >> Sam, I mean what– >> And quite a few of them underway in the intramural program >> Yes, intramural program to — and that was the one that was in there >> You are correct that proportionally they are certainly far lower than the basic, which is typical with any portfolio that we have >> Right. So again, because some of the emphasis of our report is that there should be more clinical studies, especially in the diagnostics that has — immunological mechanisms >> I think it’s fair to make that statement, if you have a concern about that >> Yeah, it doesn’t take away from it, I just don’t want the reader to say, well, we don’t need to give them any more money They’re already doing all of it >> Right. That’s why I said if you could reword that first sentence, and I think it could be done readily, you know, to say you have an extensive research portfolio that includes basic research to be [inaudible] whatever And I don’t know some way to indicate that it has clinical but they’re not as, I don’t know, prolific I don’t know what, you know, some language that you come up with for that >> It might be that is well represented you’d say >> OK >> And what they fund is what applications they receive to undergo peer review It’s a very rigorous process And nobody gets a free ride on anything And clinical studies have absolutely as big a chance of putting a — getting funded if they put in a competitive proposal as anybody >> Well, as Sam — as Sam Perdue indicated, they don’t get a whole lot of clinical studies And that’s because of the difficulty of doing them without a marker So I think the simple word as a modifier of that is I think the concern is not just me, but I hope as a working group and people in Congress >> Yeah I can accept that >> Yeah, I think Sam Purdue, you had that — I think that wording seemed good I think that was Sam Purdue that said it >> And I can assure you, we have them that come in that we’re really excited about, and they don’t make it through peer review >> Yeah >> So we suffer along with the investigators, some of those And I do that in my other portfolios that are not tick-borne as well >> Yeah, I hear what you’re saying I’m not going to argue that, but you don’t want a perception that you have enough of that and you don’t need more money for that >> This is only stating what they’re doing It’s not saying it’s enough >> Well, they — Sam Purdue just agreed And I think that if every — no one else objects, then we can put that language change in, and then it’ll be fine

>> All right, so– >> I’m just saying, some clinical studies, so that part is true >> This is Sam Purdue, and I’ve been quiet So someone else said it, but — >> Sorry >> But I do — I guess understand, you know, the both sides of this >> So you’re good to have some clinical — some — >> I said that I agree If you go back and read the texts that’d been written down I said, I agree >> Good. Thanks David >> That sums it up >> OK. You can open up that comment >> I guess people missed that >> OK. So I think we addressed that section already right there with Pat, and then my follow on comment We can move beyond that Yup, right there So my concern here was that its stated the Working Group solicited public comments I just thought we weren’t really so — I just didn’t really like the word solicited I felt that the public was — we can keep it, fine But I didn’t take to that word, visiting the right way that we were collecting the public comments They were coming in proactively on their own as well >> How about received? How about received? >> Yeah, yeah Maybe that’s a better word OK, verbal comments >> Provided opportunity for public comment >> That’s fine Something to that effect We can wordsmith it OK. And then YW, who’s that? Oh, that’s to be updated At each of the seven working group meetings OK, that can be double checked there The next comment by me, we can consolidate bullets two and three That can be wordsmith I felt Email comments, this is — this looks like there’s just some words missing here between Pat and me on an email to receive there And then a statement here about general consensus There was a general consensus among public comments Just checking with it Sorry. This is me, so I’m just reading my feedback here OK. So I already alluded to this This is just based on the writing, I really felt that some of the outcomes of the public comments from the public review was more about results versus methods And when I told — So my comments here saying, I did go back and look at the 2018 report and how it was done So this is really up to the group If everyone wants to keep it as is, that’s fine What I found, certainly no disrespect to anyone, but as we looked at the categorization of the themes here as results, if you could scroll down just a little bit, please, to the person providing the review We have the tick biology, ecology, and control, tick manifestations We have the report on how the public comments came in And I think that can be interpreted as I provide here in my comments, it can be interpreted like we’re giving results, but we’re just giving highlights of the results And I just continue to question why is that in the method section? >> Where else would you put that, Leigh Ann? >> I don’t know I mean, we could leave it as is because that’s the way it was done before, or I don’t want to cause a disruption to the process overall with the chapters I think the way the subcommittees and the process, and the methods, that whole approach was done in subcommittees and the chapter review process has internalized the public comments, and that’s already been reviewed and incorporated, if you will, into the way that the recommendations have resulted So I don’t know what to say But I just question whether it’s necessary in the methods >> Would you delete altogether? >> Well, don’t know if we can — we should delete it

I mentioned early on somewhere in my comments that we didn’t — where it was, I said where is the public comments section I mean, that’s technically like a subcommittee And we don’t really have it anywhere And since that’s a big part of requirement, you know, I think you have to have it somewhere So if we can’t put it here, then maybe we need to find somewhere else to put it I hear what you’re saying, Leigh Ann, you know, and, you know, you’re probably right about it But then the issue is, it still has to be put somewhere something about this And where do you put it if you don’t put it here? >> How was it handled in the previous report I was handled in the previous report? Sorry >> Yeah. No, I just addressed that, so thank you It’s the method itself on how we how the public comments came in is definitely warranted to be addressed here That should remain intact, in my opinion The result of all the content that comes in from the public, that has been already dutifully accepted by all the subcommittees, and understood and part of the recommendations by really all the topics and chapters So — And there’s such a huge volume of it I mean, it’s a mess It’s full time job in that So I don’t think that we can incorporate it, like in and of itself as it is represented I just don’t think we can do that And I also think it’s very difficult to, to summarize it It’s also, it’s causing a problem in the way that I said, and where do you draw the line? Where do you — You know, where do you call the boundaries In a way, I think we respect the process and say, each of the subcommittees, each of you all just leads — use what was necessary, and then included it in the recommendations, and it is embedded, it’s implicit in the recommendation >> I think that this is such an important aspect for Congress, for HHS and Congress to see And the public would be very grateful to have a separate chapter on public comments I think there then you can try to expand a little bit on each of the sections But I think this is a very important part of our working group to provide to Congress what the public is saying, whether we agree with some of it or not I think this is an important part, and I would advocate for another separate chapter You can include that under the methods, as you said, that you sought the opinion of it, and this is referenced in more detail in chapter whatever number you want to put it in But I would advocate for a separate chapter, because I think these are very important comments And I’ve read most of them And I think that they are not just dramatic sometimes, but I think objective, to a great degree, in so many aspects of what we’re dealing with >> I could only support that if we are agreeing to provide them in the report form where they’re summarized into key things, because we couldn’t possibly include every single comment We could only do it in key themes >> Just key themes I’m not advocating telling patient stories, I just think the key themes I think would have a big impact >> Well, you do have, Leigh Ann, as you pointed out, the summaries are there A lot of them don’t get even down to the individual tick-borne diseases, but there are a lot — some of them do But the point is, if we did a separate chapter, and you put in and indicated these are summaries, then you could link to the Working Group website where the other written testimonies — where the written testimonies are >> That’s a good idea >> So I’d be interested to hear the Working Group members comments I feel if we put the Federal Inventory into a separate chapter, then it makes sense from a methods and process standpoint to put the public comments into its own separate chapter >> They are two subcommittees technically >> So you want to put the other comments into the chapter or summarization

of the public comments into a chapter? >>Yeah. Yeah, thank you, Kevin Definitely not the comments There’s just no way But a summary So the key them, which for the most part is complete, because we’ve already been producing that month after month, and it would just need to be reformatted >> Right. And then just linked to the Tick-Borne Disease Working Group website, where all of the, I’ll call them the real comments, the actual comments, are there So if they want to look — you know, they see the themes and all and they want to see somewhere you can say, and you can see the actual comments on the Tick-Borne Disease Working Group website, click here, bloop >> Well, I don’t know if we’re providing this in digital form or not, but we can certainly provide that as a source if the group is in agreement I don’t know what is — >> I’d be careful with that because our methods then, when you have to have criteria before you consider it to be a key theme, you receive, and of what considered this to be a key theme I mean, how are you categorizing these? Because, I mean, this is just an interpretation of what was presented, right, with what the public comments were? >> Yeah, that’s true I mean it’s a little bit arbitrary, this time around And that is, you know, in the future if the volume is just too large and it wouldn’t be manageable Yeah, it just wouldn’t be manageable >> Well, if you’re concerned about that, you could certainly put in that chapter just do it a short chapter And it would say how the public comments were taken and, you know, the whole procedure And then do two links, put one link to the summaries, which I know that I think are already on the website And, you know, indicate these are summaries, only identifying, you know, some key themes and the working group is not voted upon these These are, you know, blah-blah-blah, and then put the link to that So you don’t have to have them all listed in there, and then put the link to the complete These are the actual, you know, statements from people >> I think you can just put that link at the bottom of this section here and this — in the methods And it’s right up front then it’s Chapter 2 — >> That would — >> Yeah >> I’m fine with that I don’t have an issue with that >> I don’t mind how this is written now I mean, it’s you could say there was a general consensus, you can qualify that by the subcommittee founder to be — they are interpreted to be a general consensus, because you’re — because if we didn’t put metrics that way determine what a consensus was That was the star interpretation as a committee, right? >> Yeah, you could say — you’re talking about the summaries, right? >> That’s right >> Yeah. And you can say something like they — Did the public comment committee And, you know, you can even give some numbers receive a zillion comments, you know, over this period of time And the committee itself, you know, tried to isolate or whatever words, you use the key themes and presented those to the working group, who also had access to the complete, you know, comments And then you can say and you can click here for the summaries, and click here for the complete comments I think that would satisfy the, you know, the [inaudible] I don’t know, maybe I’m wrong Maybe Kaye or Jim has a comment on that >> I think what you’re talking about is putting the methodology here in this message section But I still think that it’s separate Even if it’s a rather short chapter of exactly what’s listed here, as key theme needs to be called out as a separate important chapter here that would — I think, raise attention further of the people who are reading it at HHS and Congress Otherwise, it’s kind of hidden these particular key themes And I think they need to be brought out if you’re going to head and view the public input as a important part of our report

>> You’re right I won’t argue with that >> Sure. This is Kaye I’ll just weigh in here It’s really your call from a federal advisory committee standpoint, and we’re honoring the sunshine at It is important that the public is able to make comments at all meetings The old meetings are open in the public domain But how you guys decide how you’re going to present that information in your report is the decision among the body here >> Angel, what are your thoughts? >> I know, I haven’t said anything, because I could kind of rationalize it both ways keeping it as part of this section or pulling it out as its own chapter I mean, if the majority of folks on the working group are in support of having this as its own chapter, you know, even if it’s kind of small, I would be in support of that Like you said, we’ve definitely — we’ve done the work of kind of summarizing things You know, when I was reading through these different bullet points that you have here that are basically thereby chapter section, you know, I was reading through and sort of triggered additional things that I had read in the comments that weren’t actually included in your tech appear and some notes about that And, I mean, that’s the thing There are so much And as Kevin said, you know, how do we decide what to include? And, you know, just, you know, the few comments that I have here, you know, there’s a couple things that I think are important that weren’t mentioned, maybe some of these points that I brought up are not as key But if we have our own chapter, you know, then we can expand a little bit, you know, in more detail So I would be OK with that if that’s what the group would like to do >> Yeah, that’s why I wasn’t comfortable And as I read through these sections in the comments, I felt like, well, what’s to say that this is more important than something else and we’re missing so many other key themes >> Yeah >> And so then it kind of disproportionately weighs And I just didn’t like that at all >> My point — >> I think it’s a good idea to have the chapter and the chapter — the extra chapter, I think that’s the best way to go >> OK. So does anyone else want to weigh in before we make a decision to at least pull out this data and move it into a chapter right up, which we can be prepared to bring to the table next time? Or — >> I think that’s a good idea I would just say, not to take it as a mandate to expand it >> Right, well, and just utilize what we already have available, which is really the content and just reformat it? It could even be in graphic form, like the slide form just put in words in that version? >> Yeah, but what about Angel’s notes, because I think that’s important if she found key themes you didn’t address >> No that’s what we mean It’s our notes as a subcommittee, the notes and the size or the bullets So we have to just back making sure that those are depicted accurately But we’ll circle back and we can see — I don’t know that we’ll have it ready by next week It might have to be the October meeting, we’ll just see >> Pat, what I meant by notes is if we scroll down to the last page of this file, there’s just — I’ve got like five comments off here on the side of the margin That’s what I was referring to when I said notes >> OK >> Yeah >> Good, all right That’s fine I just wanted to clarify when we were talking about expanding or not expanding, I don’t know I thought they were not going to include what you indicated, OK >> OK >> This is just to make it better not omit things, so >> That’s fine >> OK. Anybody else on the working group about this? The silence will be interpreted as acceptance of the approach OK. I think we can move on then >> My phone cut out What was decided Leigh Ann? Sorry >> We’re done The meeting is over I’m just kidding >> Yeah >> We were going to go ahead and call it out as a separate chapter And we’ll work to incorporate likely the same key themes format from the PowerPoint into just a word document and make any necessary updates, but we’re going to try to leverage what we already have >> Thank you >> Yeah. And the methods, we’ll just stick to method, so just take the process only Thank you And so the discussion OK. Moving forward, I think we’re just about done here

I hope we can scroll down So, Angel, then will take your comments, and we’ll put those into the chapter discussion Is there’s anything else here you want to talk about on this or can we address that as we get into the editing? >> Oh, no, I mean I think we’ll capture it Great >> OK. And then minority response, there’s a [inaudible] OK. So, this looks like we have completed this section And we’re ready for the next chapter >> Thank you >> Next chapter is the table of contents and title page and I believe that Jennifer is going to lead us through this >> So this here in front of you is the table of contents from the 2018 report And the 2020 report will follow similar We will remain to the chapters as appropriate We’ll add in the two additional chapters that were added today, the Federal inventory and the public comment But the question would be for you all about the appendix C. And if you wanted to keep an appendix C kind of went with the — a couple of images that DBC had provided within the report Other than that, do you want to still do acronyms and abbreviations? A copy, just inventory here was a summary for three pages So I don’t know that this is needed now that you have a separate chapter And then, of course, the Cures Act and then the charter and then of course, we would have the references So the question is, obviously, we’ll have the list of the working group for the appendix A. Do you want acronyms and abbreviations again? >> Let’s have — Kat go through there and see how much we use in terms of acronyms and abbreviations And if they’re significant, I think it’s a good idea >> OK >> But they’re not — that’s not necessary >> OK. Well, I do like the recommendations I do want to include them I don’t want to assume that, folks who are — people have read the first report I don’t like to assume that So for me, that would be an important section to include >> Yeah, I think we should include it myself I don’t know why we wouldn’t actually >> OK. We would remove Appendix C, unless there were some images that you needed in the appendix, which at this time, there’s no other images that have been called out that should go in the appendix So we’ll remove that Do you think that we need the inventory or will the — >> No what we have is better than what they did last time, which was something we just put together very commonly [inaudible] and without very much else >> OK. So then C would actually be the Cures Act, D would be the charter, and then E would be the references for the upcoming — for the 2020 report >> Jen, can we see for next meeting just see a copy of this? Can you provide us with a copy to look in advance of the meeting of what, you know, what you’re saying? And then we can you know, next week, just make sure that that’s what we have in mind? >> Yeah, that’s fine >> OK. Then we don’t have to worry about well, what are we doing here? And what are we looking at and — >> Yeah, so we will make the changes based upon today’s meeting OK. And what we just discussed how that would look Also on the table of contents page, we would have the same contributions, which have Jim and Kaye and then also each of the working group members So we will draft up that as well And then you can — if there are any changes that need to be like with the MD or PH or whatever, if you need your name with the initial, then you can make the changes Does that sound good? >> Yes >> Jennifer and everybody else After the last report, there was some discussion to include some were the names of members of the subcommittee’s in the report Is that something we want to consider now? I know that was discussed before To recognize the contributions of the subcommittee members

>> I think that should be part of the methods, I agree >> I think we have that in our reports, our subcommittee reports It would be an easy cut and paste We could put it into an appendix maybe That might be a good place to incorporate that >> It’s a good idea, Ben >> Agree >> Yeah appendix, good idea >> I’m fine with that >> OK. So we can add that Would you want that after the working group and before the acronym? >> Sounds right >> OK. All right So that would be Appendix C. All right We can do that And then of course, this is the disclaimer that we will have again Are there any changes that you would want to make to this disclaimer or just this fine for now? >> I think that’s on Jim, right, that language? That official language comes from Jim, right, Jim’s office >> No, we developed that last year for the report >> Oh, thank you >> I think it’s very appropriate and does cover the fact that we’re not giving medical advice >> Agreed >> Agree >> Do we want to use the word this report rather than the report or either that or name the report? >> This is report should do it >> Yeah, it is the report >> I think it’s fine >> Yeah. It’s this report, which is pretty, you know, a lot more specific I just thought it — it’s OK >> So I just wonder, maybe this is a question for Jim or Kaye Of course, for us who are government employees, you know, on all of our publications, we’re required to place a disclaimer that what the content doesn’t represent an official view of the US government or CDC or HHS In this case, is a Federal Advisory Committee, we as government or special government employees do — are we required to say that as well or is that just implicit in the fact that it’s an advisory committee report? >> Ben is [inaudible] >> This is Jim I think it’s implicit in the report We can certainly add that statement >> Look on the screen, it’s there >> It’s already here, and it’s on the front page underneath the title of the report >> Oh, OK You guys are way ahead of me >> OK. With that, we did make changes from our March meeting, when we showed you the cover There were some specific information that you requested that we made changes due for the 2020 So we kept the same coloring Obviously, we added — changed it to 2020 We were asked to put the second report It’s not quite the same We did change up the photos as requested If you want to take a look at this and just say yes or no, we can send this to you and you can decide next week, for sure Or if you’re fine with how it is now then we can start putting some of this information in a template >> Can you send it to us so we can have a closer view and we can have time to respond? >> Sure >> Thank you >> Sure. But we did make the changes that you requested about doing the second report It still has supported by — has the 2020 we kept the information’s opinions We did keep the swoosh with the colors so that it is still part of the branding And then the coloring would still be the same and then the back was updated as you requested as well >> I think the path that the family is taking should be wider >> OK >> Yeah, I just — thank you I’d like time to respond to it Thank you >> So we’ll send this to you

But this incorporates all the changes that you all requested So that’s what we have I’ll bring back up the PowerPoint >> It’s a good point, Sam on the path being wider >> Are we good to go? >> We’re just about ready to go This is just a reminding slide to see if there’s any follow up comments for today Next steps are of course in preparation for the next upcoming meeting next week But does anyone like — Would anyone like the floor? Anything else to add? >> Yeah, I’ve got a quick question I didn’t write down the dates for the next meetings post next week Can you — Can someone repeat those again? >> So we only have the date for October And I actually don’t have it committed to memory because I just learned a bit — David, do you have the actual date? We know it’s at the beginning– is it October 17th? >> Twenty seventh, I wrote down >>Thank you Jennifer, can you confirm that? >> Yes, it’s in the chat October 27th >> Twenty seventh, OK >> I can’t see the chat because my screen is blown up so large OK. So October 27th and then we’re still waiting on the final dates for the November and December meeting Anyone else? >> Can I — just one question on the October meeting Is there a way — and I know it’s not going to be able to be final, but can we get an idea, please, of what will occur there? Can somebody write a paragraph or, you know, something that says that these are the items that we think will occur there? A preliminary, preliminary, preliminary agenda session, because otherwise, we don’t really know At least I don’t at this point, maybe [inaudible] But I don’t know >> And I’m sorry, Pat I actually didn’t understand your question or request >> Oh, OK My question is for the October 27th meeting, since we don’t know, or at least I know, I don’t I don’t know about the rest of the working group, what exactly, you know, what’s going to happen at that meeting? Can we get an advanced, not — it doesn’t have to be a formal agenda But just what are the kinds of things that are going to happen at that October meeting? >> Yes. So a draft agenda will be in development and that’ll be sent out as soon as possible >> Thank you >> OK. Anything else? All right I’d like to say thank you And David, do you have any closing comments? >> No. Thank you, everybody, for sticking in here and giving all your ideas speaking up and working on polishing this And there will be a few more steps in which I’m sure we’re going to develop a report It’s going to be just outstanding And next meeting, we’ll be going over the responses to the comments, and how the chapters are coming back And you’ve all seen those They’re Chapters 3, 4, 5, 6 and 7 And so those will be the main events next time will be to review how they have been modified since the last meeting So Jim, are you going to adjourn us today officially as a back — well, if Jim is not going to adjourn us, I’ll adjourn us You all have a good rest of the day >> OK >> Your turn Thank you got it >> OK. Thank you, everybody Bye-bye >> All right Thanks everybody have a good one > Cheers, thank you Bye