Tick-Borne Disease Working Group Meeting – December 3, 2018

Tick-Borne Disease Working Group Meeting – December 3, 2018


Coordinator: Good Afternoon.
Thank you for standing by. I’d like to inform all participants that your line has been placed on listen-only mode. Today’s call is being recorded. If anyone has any objections, you may disconnect at this time. I would like to now turn the
call over to Mr. John Aucott. Thank you, and you may begin.
John? Allen: Here. John Aucott: Oh – Allen – great.
Kristen Honey? Kristen Honey: Here. John Aucott: Vanila Singh? Wendy Adams? Wendy Adams: Here. John Aucott: Pat Smith? Pat Smith: Here. John Aucott: Bob Sabatino? Bob Sabatino: Here. John Aucott: Bob Smith? Bob Smith: Here. John Aucott: Richard Horowitz? Richard Horowitz: Here. John Aucott: Lise Nigrovic? And John Aucott – present. All right. Fantastic. So, we’d like to start off with
a review of the agenda today. We’ll start by recapping Meeting Number 7,
and then we’ll have some leadership remarks from Admiral Brett Giroir, who
will be joining us in a minute. Kristen and I will be recognizing and thanking
the working group and subcommittee members. That will be followed by an overview of the work
since our last meeting and what has happened. And we’ll get an overview of the communications
plan and summary of the communications efforts by Diane Gianelli, followed by
public comments from the public. That will be followed by Public
Comments Subcommittee report and end up with the next step in
transition issues between Working Group 2018 and what we will be calling Working Group 2020, which is the following working
group for the next 2 years. And then we’ll adjourn the meeting. So, a brief recap of Meeting Number 7, because we will be discussing
some of that more as we go along. As you recall at Meeting Number 7 was where the
working group report was finalized with a vote on specific recommendations, as
well as a vote on the full report. And so, that was accomplished
at Meeting Number 7. In addition, besides approving the reports, the working group approved
a new Public Subcommittee, which was created from working group members
to review and pass along public comments that have occurred in between meetings. We are now honored to have
Admiral Brett Giroir joining us. Admiral Giroir is the 16th United
States Assistant Secretary for Health in the Department of Health and Human Services. He serves as the Secretary of Principle
Public Health and Science Advisor and oversees the department’s key
public health offices and programs, including Disease Prevention and
Health Promotion; Infectious Disease and Vaccine Policy; Minority Health; Human
Subjects Protection; and 3 presidential and 11 secretarial advisory committees
in the Office of the Surgeon General. Admiral Giroir also leads HHS’ effort
to fight America’s opioid crisis. Previously, he served in
numerous leadership positions in federal government and
in academic institutions. Most notably, he was the first
physician to be appointed as an office director at the DARPA group. He’s previously published 100 peer-reviewed
publications; holds patents on a number of bio-medical inventions; and
has received numerous awards, including the American Heart Association’s
President Lyndon Baines Johnson Award for Research and the U.S. Secretary of
Defense Medal for Outstanding Public Service. As a pediatric critical care physician, Dr. Giroir cared for critically
ill children for 14 years. He continues to bring that hands-on,
patient-centered perspective to his work as Assistant Secretary for Health. Thank you for joining us. Admiral Giroir: Well, thank you very much. And it’s really a pleasure
and an honor to be here, and I’m pleased to be able
to provide a few remarks. And I must admit, I haven’t seen your
PowerPoint logo slides to this point, and I think it’s quite creative
with the tick actually there. So, everybody knows that
this is a branded group. We know what you’re about. So, just under 1 year ago, this committee
was charged with the-the remark said “momentous task”-I would say “Herculean task” of
being the first-ever federal advisory committee to address tick-borne diseases and conditions. Representing the perspectives of
patients, caregivers, advocates, providers, and researchers, you have formed a collaboration
that is really historic in its scale. Never before have such diverse stakeholders
come together in a federal platform to tackle the urgent public
health issue such as this. I can tell you personally that, for a period
of months, I received an equal number of emails from patients, workers, scientists
involved in tick-borne diseases as I did for my entire rest of emails throughout HHS. So, the extent of interest,
the importance of the issues, the absolute need for an advisory committee
to bring some equilibrium to the system so that we can all move forward,
I think, was really a huge task. And I did note as the, I kind of judged the
successes of the task force by the fact that, as time went on, my emails went
less and less and less and less. At first, there were hundreds per day,
and then they were hundreds per week, and then there were only 10
per week, and then dwindling. And I do mean that, that if the task force did
not take everybody’s views and understand them and synthesize them in a cogent way that went
anywhere from vector control to accessed care to diagnostics, then that
wouldn’t have happened. So, that’s one of those indirect metrics,
but I think a very, very important one. Not that that isn’t over yet. But with 67 subcommittee members,
you really did deliver on the charge by presenting your expert assessment of
federal efforts and research priorities related to tick-borne diseases in the first of three
reports to Congress and the HHS Secretary. And again, it’s no problem saying, “We
don’t know and need more research.” “We don’t know” and “not completely
understanding” is an absolutely fine answer. As long as that is the answer, and
we have a direction which way to go. And I think the balance of being humble
about what we do know and what we don’t know and being transparent about that is very,
very important, and I think that really came out in the committee report, at least to me. And having read the report, I
really am impressed at what was done in a really relatively short period of
time because of the high amount of work. The report goes into contentious issues, but I
think it provided very thoughtful and insightful and meaningful recommendations to
improve our response and approaches. And I really appreciate, truly
appreciate everyone’s work. And I know the community and the nation,
as a whole, appreciates the work. And the people next door in Congress
certainly do appreciate the work, as well. There is, of course, high interest
because of the extent of the disease. So, the goal of today’s meeting
is a couple-fold. First, it’s a thank you for your
commitment to this working group, which aims to help tick-borne disease
patients nationwide, but also to look ahead. Because even though we are just wrapping up
the first wave of this, we need to look forward and shift our focus to the next
cycle of the disease working group and begin preparing already for
the 2020 report to Congress. So, I hope that today’s meeting will
prove useful in laying that ground work. You know, I understand your time
here is-on the committee-is limited, and your work is abundant, if not overwhelming. So, again, we appreciate your work. And I meet with Jim very frequently about,
is there anything we can do to support it? And, again, I stand ready. You know, part of my goal is to make sure
things are working but not to interfere, because it’s very important that the FACA is
independent and works according to processes, and that’s the only way that we
build trust throughout the scientific and the patient communities is to
make sure the process is transparent and pristine and without outside influences. That being said, I’m very
interested in the topic, you know, as a pediatrician, critical care doctor. But mostly in infectious disease, this
is, you know, fascinating scientifically. It’s very challenging medically. And it raises a panoply of
issues that we all know that it’s just not science
that we have to deal with. It’s everything that surrounds that and how
it’s communicated, and how it’s implemented within society, and the feedback
that we have, and all the factors that we need to take into account. So, that’s really all I wanted to say today. I’m happy to answer any questions
or make any other comments. Jim. Jim Berger: No. Thank you Admiral Giroir. You addressed the issues. You gave a choice to move forward, and we
appreciate your support of this committee. John Aucott: Thank you Admiral Giroir. Thank you very much. So, one of the themes, as the Admiral
pointed out, today is recognition and thanks. And so, we are going take some time to now
recognize the 14 working group members, especially the many, many subcommittee
members, and also the people that participated in their subcommittee meetings-the invited
speakers, the public and public comments, the people who courageously
shared their stories. All of the people that were
essential to making this a balanced and effective report, we want to thank them. So, if you recall, there were six subcommittees
formed to cover six different areas of the working group report: The Disease
Vectors, Surveillance and Prevention Committee; Pathogenesis, Transition and Treatment; Testing
and Diagnostics; Access to Care Services and Support to Patients;
Vaccine and Therapeutics; and Other Tick-Borne Diseases and Co-Infections. And then, at the last meeting, there
was an additional subcommittee created for Public Comment. So those are the subcommittees
that we want to recognize today. The subcommittee membership
was important to review. There was at least one patient or patient
advocate on each of the subcommittees. And each subcommittee was led by two co-chairs, at least one of which was a public
member or non-government volunteer. They met frequently over a
3-month period, usually weekly. And they had a lot to do. They had priorities that
developed the subcommittee report that examined current efforts in tick-borne
disease research and efforts, gaps in research, and potential access to address each priority. And these reports were put together
to inform the whole working group in their creation of the working group document. Subcommittee reports included input from
experts, advocates, patient representatives, collective study committee member knowledge-as
many of them were content experts-and, as well as an informal literature review. And they presented their
work at Meeting Number 4 where the subcommittee co-chairs presented
the findings to the whole working group who would then make the decisions
about what aspects of the reports, as well as other information, would be
included in the final working group report. It was a monumental undertaking
in a really short period of time, and that’s why we really wanted to recognize
the individual members-the subcommittee members-because they came in and really did
the heavy lifting of creating the information that went into the working group report. They haven’t been thanked enough, and today,
we really want to focus on thanking them and making sure that everyone knows what a
herculean effort these individuals contributed. Kristen Honey: Great. Thanks so much, John. And with all the subcommittee reports,
only a subset of information could make it into the final working group report. But you can find the full final subcommittee
reports on the website in the report section. And you can see it was a
huge, huge amount of effort, and we could not have done
it without the subcommittees. So, first up, we would like to thank the Disease
Vectors, Surveillance, and Prevention Group that was led by co-chairs
Pat Smith and Ben Beard. And many, many thanks to Jill Auerbach, Thomas
Mather, Phyllis Mervine, Colonel Robin Nadolny, Alberto Perez de Leon, Daniel Sonenshine,
Jean Tsao, Monica White, and Stephen Wikel. And I wonder, Ben and Pat-I guess
it would be Paul and Pat-might you like to say just a couple sentences about your
subcommittee, because they really came together across a diverse team – worked incredibly well. Paul Mead: Well this is Paul. I’m certainly impressed at the work that was
done by the committee, but I’ll defer to Pat who really has a better feel for it. Pat Smith: Well, I certainly was very pleased. I think we had a diversity of individuals. They came from all across the
country, all different areas. And not everyone shared the same opinion,
but yet, the bottom line was we came together when it was necessary, and we did
it in, I think, a professional way. I was very pleased, and I certainly
thank them very, very much. Kristen Honey: Great. Thank you both so much. And then, passing the baton
over to the Pathogenesis group. John Aucott: So, the Pathogenesis,
Transmission, and Treatment Subcommittee led by Wendy Adams and Estella Jones. Membership included Nicole Baumgarth, Pat Coyle,
Sam Donta, Brian Fallon, Lorraine Johnson, Elizabeth Maloney, John Skare,
and Brian Stevenson. And if Wendy or Estella have
any brief comments… Wendy Adams: Yeah. I just wanted to thank everybody on our
subcommittee because we had a lot of range to cover because we covered both
what was happening in the tick and what was happening in the human. And that’s a lot to cover both
scientifically and in a written report. So, I want to thank them
for their really hard work. I feel like we put together a
really detailed subcommittee report, and that was due to their hard
work on nights and weekends. And really, everybody contributed. And so, I really have a heartfelt
thanks for putting together this report and working with Estella and me on it. Estella Jones: And I just
wanted to add to what Wendy said and say that we are still
not finished with our work. This is Estella. And if you read the Washington Post article-the
Asian longhorned tick made the Washington Post yesterday. Pretty frightening because that incident with
the sheep is in Northern Virginia where I live. And we are expecting that to really get some
attention for, as practicing veterinarians, that has really caught our eye, so we know a
lot of diseases that we’re not used to treating and preventing will certainly
catch our eye in the future. And then, preventing the devastation in
our livestock and in our pets, as well. So, if you haven’t taken a look at that
article, it’s definitely attention-worthy. Kristen Honey: Great. Thank you so much to that subcommittee. Next up, we have Testing and Diagnostics, which was led by co-chairs
Lise Nigrovic and David Roth. And this subcommittee-huge thanks and shout out
to Holly Ahern, Charles Chiu, Roberta DeBiasi, Noel Gerald, Deborah Hoadley, Maliha
Ilias, Bobby Pritt, and Steven Schutzer. Next up, we have the Access to Care
Services and Support to Patients, which was the largest group of all of them. And we had help from many, many, many people. And of all the subcommittees in the
public comments, the majority of them came in my-you know, from reading through
them all-with patient outcomes, access to care-health care-and
support for patients. So, this committee really did the bulk of the
work, reading through all that, synthesizing it, and packaging it up for the working group. Led by co-chair Scott Cooper and Paula
Jackson Jones and included Anna Frost, Robert Bransfield, Sherrill Franklin,
Holiday Goodreau, Colonel Nicole Malachowski, Leonard Schuchman, Sheila
Statlender, Kathleen Steele. And then also helped us get off the ground
and gave instrumental support and rolled up their sleeves and great
feedback that was essential for the final work-the subcommittee report-
was Karen Vander Huforsner and Enid Howler. And with that, Coop, would you
like to say, like, one sentence? Scott Cooper: Yes. I can’t thank this group enough. You know, they took a lot of personal time. And I know I’m going over one sentence, but… And to particularly thank Paula
Jackson-Jones for stepping in as my co-chair. She did incredible work and
pulled everybody together. So, yeah. And just the amount of personal time. And this subcommittee got so much
attention, you know, on social media. I really do appreciate everybody
sticking in there and sticking with us. So, thank you. John Aucott: Next subcommittee
was Vaccine and Therapeutics. Co-chairs: Dennis Dixon and Robert Smith. Subcommittee members: Felipe Cabello, Monica
Embers, Maria Gomes-Solecki, Utpal Pal, Stanley Plotkin, Juan Salazar,
and Leigh Ann Soltysiak. Dennis, do you have any comments? Or Bob? Dennis Dixon: Yes. Dennis here. My main purpose is to thank all the members
who were so collegial, so thoughtful, brought so much energy and
intellect to the discussion and so respectful all the
way through the process. We really feel like we came together
nicely as a group, heard multiple views, and I believe everyone was
comfortable with what we generated. A great networking team that
we built and utilized. John Aucott: Thank you. Next subcommittee was Other Tick-Borne
Diseases and Co-Infections led by Richard Horowitz and Allen Richards. Subcommittee members were Megan Dulaney, Marna
Ericson, Christine Green, Charles Lubelczyk, Ulrike Munderloh, Garth Nicolson, Christopher
Paddock, Sam Perdue, and Sam Telford. Richard and Allen, any brief comments? Richard Horowitz: Yes. This is Richard. Thank you, John. So, yeah, I want to also give a big thanks
to everyone who put in such hard work. It really was historic because we
had people from the CDC, the NIH, the Department of Health, Department of Defense. Researchers, clinicians had
open, respectful conversations. I personally learned a lot, and
we had a broad range of tick- borne infections and co-infections to cover. So, I’m very proud of the work our
committee did and very thankful because it really was a wonderful
process working with everyone. Kristen Honey: Excellent. Thank you so much, Richard and everyone. And the last subcommittee might
be small, but it’s mighty. We are the Subcommittee on
Public Comments and the only one that is still meeting on a regular basis. And every month, this group gets
[email protected] emails and every single person on this committee
is committed to reading them all, synthesizing them, and then packaging them up
for ideas for the working group to consider. So, there was myself, Richard Horowitz,
Bob Sabatino, and Scott Cooper. And just huge thanks to all of you
and your commitment to the public and to all the public comments we received,
which is way, way more than any other FACA group and way more than any other HHS
project that I am involved with. So, thank you all. John Aucott: Briefly, an overview of the work
that has been going on since our last meeting. After we voted on and approved the working
group report, the report was copyedited by our contractor at least four times
for the copyediting phase of the report. In addition, the report was sent
to several agencies-CMS, NIH, and CDC-for informational purposes. And only factual discrepancies or
copyedits were made at that time. There was no change in the content
of the working group report. Third, the report was sent to HHS
Legislative Affairs for review. And finally, the report was submitted to
Congress and the Assistant Secretary for Health; the Committee on Energy and Commerce
of the House of Representatives; and the Committee on Health, Education,
Labor and Pensions of the Senate. I’m now going to turn it over to Diane to review
the communications plan and what has happened with communications of the
report since it was released. Diane Gianelli: Okay. Hi. This is Diane Gianelli. I’m going to briefly talk about the
rollout, which was Wednesday, November 14. From our end, that means the day before
the release, relevant Capitol Hill members and staff were notified because a
lot of them have a lot of equity in this particular FACA Committee. Relevant federal officials
were notified earlier. And the weekend before the official rollout, we
sent embargoed copies of the report to a number of members of the press who had covered
tick-related stories in the past. And quite frankly, we really weren’t expecting
to get much of a bump of that because, usually, when a federal advisory committee
makes recommendations, that doesn’t necessarily
translate into any action yet. So, we are not really used to
seeing the press pick up on that. But, we went ahead on the morning of
Wednesday the 14th and put the report and press release online, and we sent the
press release out widely to all the reporters who signed up to receive HHS releases. And, you know, from a government perspective, we
really received a surprising amount of interest. I’d says there were at least 20
stories-a lot of them were big guys. We had NBC, CNN, Science
News, New York Daily News. This is perhaps coupled with the
fact that the CDC, at the same time, announced its newest numbers on
tick-borne disease prevalence. So, from our perspective, CDC presented the
problem; your group presented the solution. It was a perfect storm. John Aucott took the bulk of the
press calls and was a true rock star. He and I spoke several times over the-it
was a holiday weekend, as it turned out, which is why the date kept musically,
you know, moving from date to date. But he did talk to reporters over the
weekend for the embargoed interviews, and I tracked him down at the
health club, in the parking lot, in his breakfast table, et cetera, et cetera. But it all went well. Even, to my surprise, this week,
we are still receiving queries. And John just recently-it might
have been yesterday-did an interview with the American Association for
Clinical Chemistries e-newsletter CLN Stat. So, we should be seeing something from that. So, all told, it really was
a, it was a great rollout. Everything just went smoothly, and
everybody did as they were supposed to do. And I’m looking forward to the next one. John Aucott: Thank you, Diane. Diane Gianelli: Sure. John Aucott: Alright. We’re going to transition over to
our public comments section now. During the public comments
section, now, we will have people that have pre-signed up for speaking slots. Every slot is 3 minutes. We respectfully remind everyone that the 3-minute time is concrete
in fairness to other speakers. So, the line will fade out at 3 minutes. I’ll also remind the working group members
that this is not an interactive call. There is not the chance to ask or receive
questions during this time of public comment. And with that, I’m going to
turn it over to the operator. Coordinator: Thank you, and our
first caller is Peg Strickland. You may begin. Peg Strickland: Hi. Thank you for allowing me
to speak, first of all. I was diagnosed in October 2015 with
alpha-gal after a multitude of bites from either chiggers or larval ticks. I have submitted to you all via email
a lengthy summary of my experience, which involved passing out, a day and night in
the hospital, dangerously low blood pressure, and several other symptoms, which made the
doctors think I had possibly suffered a stroke. I say this to express the
severity of an alpha-gal episode. It can lead to anaphylaxis and death. Two experiences in the ER convinced
me that the doctors, the staff, and even labs are woefully uninformed. The side effects of alpha-gal, including
anaphylaxis, can be delayed several hours. I was informed on both my ER visits that
anaphylaxis is always immediate, never delayed. This is one reason we need reclassification
of alpha-gal as a life-threatening occurrence. Consuming anything mammalian
can endanger your life. Somehow the mammal threat needs to be included
in the description or the name of the disease and in literature to health care providers. Alpha-gal is often referred
to as the red-meat allergy. This might lead some to think that
they’re safe to eat pork, for example. Mammal is found in many medications
and consumer products. Cross-contamination in food
preparation is a threat. Food and medication labels need to be
modified to list mammal ingredients. Gelatin, for example-a mammal ingredient-is
used in gel caps or even to refine wine. Calling a drug manufacturer is often
unproductive, as they are frequently unable to source much-used ingredients, such as
glycerin, as either animal or vegetable derived. I urge you to consider beefing up warnings for
the public, for hospitals, doctors, schools, and restauranteurs about alpha-gal. I’m sure school nurses are vastly uninformed. And I shudder to think of the impact on a child
who has not been correctly diagnosed and warned or a restaurant manager who might
find himself culpable for something of which they were totally unaware. Again, I thank you for your time. I appreciate it very much. And if you need to contact me
for any reason, I am available. Jennifer Platt: Good afternoon. I am Jennifer Platt and hold my
doctorate in public health from UMC. I am the founder of TickWarriors
and Tick-Borne Conditions United and live in Pittsboro, North Carolina. In her groundbreaking 1999 essay, Leverage
Points: Places to Intervene in a System, Donella Meadows proposes that
to solve complex problems… Coordinator: I just hit her
open, and she went on… Jennifer Platt: … we must use many different
levers, or points of influence, to make sustained change in the system. I strongly encourage you to expand the
groundwork laid in your 2018 report. We can make sustained change by working
to influence many different levers. Some ideas to explore: first,
consider the impact and opportunities of other ecological players in nature. Many bacteria, fungi, spiders, ants, beetles,
rodents, birds, and other living things serve as natural predators or limiters
of tick populations. Yet few experimental data exist on their impact. We can start by looking at
how disease reflections in the population mirror what’s
happening in local ecology. For example, researchers are starting
to notice that, where higher rates of fire ant anaphylaxis happens,
alpha-gal syndrome, or mute anaphylaxis, is less prevalent or even nonexistent. Fire ants eat ticks. If you are ever bored, watch
YouTube videos of how they do it. Similarly, we’ve seen that decreased deer
density shows a lower incidence of Lyme disease. Large-scale landscape management processes, such
as keeping continuous areas of mature forest, in conjunction with increased hunting, is a
fairly simple and inexpensive control method. Second, we need to explore
these ideas and engage with the federal integrated pest management
group that includes EPA, DOI, and USDA, especially in light of the growing appearance
of the invasive Asian longhorned tick. We even need to solicit increased participation
from and with the public health sector. I was dismayed to see a total of zero
papers presented on ticks and the burden of disease at this year’s conference. Third, let’s look to international
work and prevention. For example, the “freeze, don’t
squeeze” mantra out of Australia. Fifteen years of research shows
that when a tick is killed in situ, up to 99% of patients could avoid
tick bite-induced anaphylaxis. How can you apply this knowledge to disease
transfer from bites here in the U.S? Einstein famously said that
problems can’t be solved at the level of thinking that created them. I strongly encourage us to look at multiple
levers for change and to also be thinking ahead to minimize potential adverse
impacts of today’s decisions. What problems will be created
out of these solutions? For example, people wearing military uniforms
treated with permethrin and used in hot and humid conditions have up to two times
higher metabolite concentrations of permethrin. Thank you for the ongoing opportunity to submit
written and verbal public comments-a critical and vital part of your role in reducing the
impact of tick-borne diseases and conditions. We are stronger together. Coordinator: The next speaker
is Lorraine Johnson. Lorraine Johnson: I’m Lorraine
Johnson, the CEO of LymeDisease.Org and the principle investigator of MyLymeData. This comment will focus on the use of the term “Post-Treatment Lyme Disease
Syndrome,” and how it harms patients. The term PTLDS, which specifically incorporates
the CDC surveillance case definition, was first proposed in 2006 by
the Infectious Diseases Society of America in its Lyme guidelines. It was intended to provide “a
framework for future research.” Earlier that same year, a CDC cost-of-illness
study by Zhang based the study inclusion on physician diagnosis of chronic Lyme
disease and rejected surveillance criteria as not being clinically relevant. The CDC has long cautioned against using
surveillance definitions for diagnoses because these definitions-like research
inclusions-serve a very different purpose and are designed to measure only
a fraction of clinical cases. Hence, surveillance cases
miss 9 out of 10 cases. Clinical data sources: notably a recent
Quest Lab study and a big data study by the Fair Insurance Claims database show that surveillance numbers are
dwarfed by clinical cases. Likewise, the NIH-funded chronic Lyme disease
studies, which have used some variation of the surveillance criteria for
enrollment, screened out most patients with [unclear] screening
out 97% of those who apply. Lyme patients object to the terminology
PTLDS not because patients are unscientific, but because definitions suitable for research and surveillance are inappropriate
for clinical care. They leave out the majority of patients by
design and measure only the tip of the iceberg. Their goals aim for methodological
precision over clinical relevance. In addition, the very language of the term “Post-Treatment Lyme Disease
Syndrome” assumes two things. First, the patients have received
adequate treatment, and second, that the cause of their continuing
symptoms is a post- infectious disorder. There is no evidence that either
of these assumptions are true. Many case reports document
culture-confirmed Lyme from patient biopsies and nobody knows what the adequate
treatment is for these patients. Physicians and insurers use PTLDS terminology
to deny diagnosis, treatment, and reimbursement. Researchers are free to use restrictive
research study enrollment criteria, but they should not saddle a medical condition
clinically with unproven scientific assumptions about causality or adequacy
of previous treatment. At its recent conference this
year, IDSA member Adaja tweeted that the upcoming Lyme guidelines
will drop PTLDS terminology because it implies causality
that hasn’t been established. I hope this is true. This terminology harms patients by
excluding most of them from the hope of obtaining the diagnosis and
treatment necessary to get well. Thank you for your time. Coordinator: Our next speaker is Betty Gordon. You may go ahead. Betty Gordon: I wish the PTLDS was not
shown in the report that went to Congress. This is an insult to all of us
tick-borne patients-me for 49 years. I misdiagnosed for 35 years
by [unclear] doctors. Unacceptable. Then, to add injury to insult, it
took my husband’s two brain autopsies to find his brain make worldwide history having
two diseases never found together before-Lyme disease and Lewy Body Dementia, causing visual and very violent hallucinations,
like Robin Williams had. Plus, a cluster of nematode
parasitic worms having Lyme, too. His second brain autopsy found two species
of Bartonella, the cat scratch disease. Doctor Alan McDonald called me on 11/22
of ’15 to tell me the other findings. I finally knew what he had, scientifically,
that the medical community said he did not have. Alan promised me, “Betty, you’ll be the
first co- author over three medical folks to be written and published by
a scientific medical journal.” Then, due to unforeseen circumstances,
Alan was unable to find, to write his findings to submit for publishing. I’m angry for the following things. I have to file a lawsuit petition-costing
me $200 to file-to amend that all of the above contributed to his death. The Department of Health,
DOH, is going to fight me. They told my attorney, involving
their Attorney General’s lawyer, our examiner’s office gave
different information to my lawyer. Both have to be served papers, costing $75 each,
which I would be happy to deliver free to them. DOH told me, “Jack will never be
counted in our CDC Lyme statistics,” even if I win the lawsuit explained above. The CDC statistics have been filed, never
to be opened again, although they have known for 3 full years what Jack’s
first autopsy results were. This makes me so angry. My lawyer told me they will want to
have an expert in the field testify, costing me at least $10,000 plus prep time
(doctor’s get $500 to $1,000 plus prep time). This will be a costly battle
for me to undertake. I’m angry because Jack was
diagnosed with advanced lung and liver cancer 2 nights before
he died 4 years ago tonight. Malignancy thought to be metastatic
lung shows the reason he died. Contributing factors showed Parkinson’s
with dementia, chronic renal failure. When I began this 3 years ago. I had the contact with DOH explaining
what was on Jack’s first brain autopsy. The health director said, “Betty, yes. These things contributed to his death
and should be on the death certificate.” Since then, she’s retired. This is so wrong. It needs to be corrected now. Can you tell I’m very upset with the entire
system plus the hogwash of the PTLDS? Thank you to all the reps from
working groups and the subcommittees, having worked their butts off and put
their hearts and soul into everything. Mother Theresa said, “God, even I have a limit.” Well, so do I. My PC was hacked. All Jack’s slides and texts are gone. Jack’s healthy 3- year old daughter
died 3 days after her smallpox shot. Thank you for letting me contribute to this. And, I’m from Iowa. Coordinator: Next, we have Deborah
Flushman [spelled phonetically]. You may go ahead. Deborah Flushman: People who have
alpha-gal syndrome cannot have medication or food with mammalian-derived ingredients. Nor can we predict how our bodies
will respond after being exposed. As of November 26, 2018, the FDA medication
shortage list contained 110 medications. The majority of those lists
are not alpha-gal safe. When this, in itself, is a major problem. However, today, I’d like to focus on the
ones on the list that are alpha-gal safe. Epinephrine injection and Epi-Pen from Mylan,
Diphenhydramine inhalant (brand name Benadryl), ranitidine (brand name Zantax), cromolyn sodium
inhalant solution and ketotifen for capsules, sodium chloride injections solution
in vials, multivitamin infusions. As a person with alpha-gal who has
7-month post-expiration-dated Epi-Pen, I’m very concerned with how risky it is
for me to have an expired Epi-Pen to rely on for a life-threatening situation. I have used my Epi-Pens at least 12
times since contracting alpha-gal. We need them to keep from going into anaphylaxis from unknowing mammal consumption
or cross contamination. All of us in the alpha-gal community
are currently living in fear that our expired Epi-Pens
will not effectively revive us from a life-threatening situation:
allergic reaction. And even if we do make it and use,
use it to make it to a hospital, we worry that the hospital will not
be adequately and sufficiently stocked with lifesaving medications,
previously mentioned, for anyone who has alpha-gal to be treated with. People with alpha-gal are unique in
the fact that we have special needs that the other tick-borne diseases do not have. We are allergic to all mammalian ingredients,
which makes us more dependent on the FDA for what consuming mammal
does to us and the lack of eating mammalian meat also
does to us nutritionally. We are 100% reliant on the FDA for our
safety, and we are highly concerned with what the FDA is going to do
about these medication shortages. It is our concern that if safe medication
shortages are going to continue, that we need the FDA to provide us with
safer labelling on our food products so that we can reduce exposure to cross-
contamination from mammalian sources that are mislabeled or not
mentioned as ingredients in our food. This needs to be extended
further than just food. We have always needed all medications to reflect the same safe
labeling: no mammalian ingredients. We need safe labelling for
preventive care and so none of us accidentally has a life-threatening
event occur due to the lack of medications because they are either expired, in short
supply, no supply, or lacking safe labelling, which could potentially put
a person with alpha-gal in an emergency anaphylactic
position, which could kill them. Thank you for your attention and
consideration regarding this matter and all that you have done for us. Coordinator: Dorothy Leland is next. Dorothy Leland: My name is Dorothy
Leland, and I live in Davis, California. In 2005, my then 13-year-old daughter
became seriously, mysteriously disabled with unremitting, body-wide pain that kept
her in a wheelchair for more than 3 years. Medical experts we consulted had no clue what
was wrong and could do nothing to help her. When we asked if it could be Lyme disease, they
answered emphatically, no because, they said, there is no Lyme disease where we live. That’s what I now call “misdiagnosis
by geography.” That was 13 years ago. Eventually, we found Lyme-knowledgeable
practitioners who recognized what she had
and lead her back to health. It was a long, arduous, expensive process. I soon became involved with LymeDisease.Org
and also co-authored a book called When Your Child Has Lyme Disease:
A Parent’s Survival Guide. Doing this work, I have met hundreds of Lyme
patients and their families, either in person or online, literally from around the world. And misdiagnosis by geography is
one of their chief complaints. Whether they live in California or New Mexico
or Arkansas, Canada, the UK, or Australia, they tell me that when they
first went to the doctor, they were told it couldn’t be Lyme disease
because there is no Lyme where they live. For years, the CDC insisted
that virtually all Lyme cases in the U.S. took place in only 14 states. That assertion was weaponized against
Lyme-infected people in the other 36 states, often making it so doctors refused to even consider Lyme disease
in their differential diagnosis. As a result, untold numbers of people
lose the crucial advantage that comes from early treatment of the illness
when a good outcome is most likely. Instead, they are left to suffer without proper
care, taking a severe toll on their health, their livelihood, and their
family relationships. In the case of sick children, it can steal
their childhood and derail their education at a huge cost to themselves, their
families, and society at large. While the CDC’s narrow surveillance data says
Lyme is sparse outside of the “magic 14,” other sources paint a different picture. Quest Laboratories reports that it has
found Lyme disease in all 50 states. The Fair Insurance Database shows large numbers
of Lyme-related claims throughout the U.S., including in states considered
low-incidence by the CDC. And LymeDisease.Org’s patient registry,
MyLymeData, reports many more cases in those outlying states than the CDC does. Lyme-related misdiagnosis by geography
should not be a thing in the U.S. anymore. Our system for tracking Lyme
cases is broken and must be fixed. Thank you. Coordinator: If Phyllis Mervine
– please hit Star 0. Phyllis? Phyllis Mervine: Yes. Coordinator: Phyllis Mervine, you may begin. Phyllis, you may begin. Phyllis Mervine: My name is Phyllis Mervine. I’m the founder and president of the patient
advocacy [unclear] to stifle the voice until you have found evidence-based
science to direct care for their patients. They say, “We are extremely concerned by the non-evidence-based approach
favored by the working group.” I’d like to ask, who decided the IDSA is the
sole arbiter of what constitutes evidence. IDSA conveniently ignored the evidence that chronic Lyme disease
exists and doesn’t treat it. So, how could they be experts? If someone presents evidence that doesn’t stick with their theories, they
say it’s not convincing. The Lyme guidelines are more than
10 years old and were removed from the National Guidelines
Clearinghouse website almost 3 years ago because they were out of date. The IDSA has no grounds for
attacking the working group. The last time the IDSA published
new Lyme guidelines was in 2006. They were almost immediately called
out by the Connecticut Attorney General for commercial conflicts of interest
and suppression of scientific evidence. When the terms of the settlement called for-I’m
sorry-called for a panel to be established, the IDSA called it independent, but the
panel members were actually all members of IDSA and, by definition, not independent. Later, the Institute of Medicine
used the IDSA Lyme guidelines as a poster child of how
not to create guidelines. The International Lyme and Associated Diseases
Society 2014 Guidelines were the first Lyme guidelines to meet the stringent
standards of the Institute of Medicine for trustworthy guidelines. They are evidence-based, and
earned by the grade system, and were listed on the National
Guidelines Clearinghouse website until its demise earlier this year. They take a very different view
of the evidence from the IDSA. The problem is that the IDSA’s
narrow views and refusal to accept new evidence makes
it difficult for them to see that someone else might have
better answers than they do. Their claim that the working group is biased
against scientific evidence is unfounded. The working group brought
well-qualified scientists from every field, including several federal employees from
the Vector-Borne Division of the CDC. The doctors in the working group
have experience in treating thousands of patients at all stages of Lyme disease. LymeDisease.Org’s big data project, MyLymeData,
may give us more insight about responders and non-responders to various treatments. And I’m hoping that the working group will come
up with some answers that the IDSA has failed to provide through their restrictive approach. Thank you. Coordinator: Kathy Nodolf may begin. Kathy Nodolf: After following the
progress of the working group, it is not… Can you hear me? Coordinator: Yes. Kathy Nodolf: Okay. I’m sorry. After following the progress of this working
group, it is not surprising to discover that there has not been much progress made that
would benefit the majority of Lyme patients. If anyone really expects the Kumbaya moment
where the philosophies and members of ILADS and IDSA would cooperate, work together,
and come up with a joint document that truly helps the victims of chronic Lyme
disease, you must be living in a fantasy world. Two peers requested a seat at the table to
bring a viewpoint based on scientific studies, which would help avoid this useless
two-sided argument to nowhere. We were denied. I know you are catching a
lot of grief from all sides. Cynthia Sears, president of the IDSA, wrote you
a letter dated November 25 that excoriated you for IDSA’s perception that the working group
is bias towards the chronic patients, and yet, the chronic patients are claiming
that you are bias toward IDSA. Well, you can disregard Ms. Sears inappropriate
lashing because she seems to have forgotten that her colleagues wrote in December 2015 that “the effects might be the more
important functions of PLR signaling,” meaning that an immunosuppression
is the main driver of the disease. This finding recently was supported by a
study funded by Bay Area Lyme Foundation, and Lyndon Hu, a colleague of Allen
Steere, has received a substantial grant to conduct a research on this very phenomenon. Last month, a group led by [unclear] out
of [unclear]) University corroborated all of these findings when they showed that even serum-negative Lyme patients carry a
heavy disease burden with reactivated viruses and multiple opportunistic infections, which
brings us back to IDSA who, a full 5 years ago, endorsed molecular methods for
diagnosing such infections. It’s a policy paper-better tests,
better pairing, who’s [unclear]. Therefore, you can ignore
anything IDSA says to the contrary. The IDSA 2000 and 2006 Lyme disease panels
refused to accept or even consider the existence of chronic Lyme disease, once removing a
member from the 2000 panel who dissented from the group’s physicians, so they
could achieve so-called consensus. Here we are, 12 years later, and the
very reason for this working group where the IDSA has no clue that we have already
been here excluding chronic neuro-Lyme just as they did at deer-borne. I would like to quote my friend Laura. If you have to be [unclear] on a healing
journey through an alternate universe where you are the failure, if you are still
sick despite losing your home and retirement to pay doctors who must not be
named for treatment she discovered on Facebook, you might have Lyme. Might I add, you might also want to start
questioning, why is this so political? Coordinator: Carl Tuttle, you may begin. Carl Tuttle: Sure. It is no secret that the U.S.
Centers for Disease Control had a… Kathy Nodolf: Whoa. That shouldn’t have gone to mute. Should’ve just… Man: You’re off. Coordinator: Carl? Carl has hung up. Is there a Bethany Welsh? Please press Star 0. One moment please. Bethany. Bethany. Bethany Welsh you may begin. Bethany Welsh you may begin. Bethany? One moment please. Carl Tuttle has called back in. He may begin. Carl Tuttle: Yes, it’s Carl Tuttle from
Lyme Endemic Hudson, New Hampshire. It is no secret that the U.S. Centers
for Disease Control has aligned itself with the seven defendants named
in the Texas Racketeering lawsuit. The CDC has been able to perpetuate this 30-year
illusion that Lyme disease is difficult to catch and easily treated through focusing on the
acute stage of disease after early treatment. For example, the CDC financed Gary Wormser’s
5-year study of the acute stage of the disease to the tune of 1.5 million tax payer dollars,
published in 2010, known as Subjective Symptoms after Treatment of Early Lyme Disease. His results: At 12 months after enrollment,
only 5 of 230 patients reported new or increasing symptoms, and in none
of those patients were these symptoms of sufficient severity to
be functionally disabling. Summary of Wormser’s study:
Anyone experiencing symptoms after the one-size-fits-all early treatment
approach is just experiencing nothing more than the aches and pains of daily living. So basically, Wormser’s results are then assumed
to apply to the entire patient population. In other words, Lyme is no big deal. Purposefully avoiding the advanced stage
of the disease hides the horribly disabled, and anyone unable to see
this is somewhat naïvve. Many infections, as I continue to point out,
evolve into an entirely different and serious, life-altering disease when left untreated. Post-Treatment Lyme Disease Syndrome
and untreated Lyme of months, years, or decades are two entirely different disease
states, the latter being ignored for 3 decades. What is the motivation for
downplaying the severity of Lyme disease while ignoring
patient outcry for 30 years? So, 40 years have passed since
this disease was first recognized, but we still don’t know how Lyme disables
its victims, so that we can figure out what we’re dealing with here
and how to treat it properly. In other words, the CDC must
stop focusing on the acute stage of the disease after early treatment. But this has been avoided at all
costs to maintain the status quo. The research into how Lyme disables should have
been completed by now, but the misclassification of Lyme as a simple nuisance disease,
hard to catch and easily treated, has negatively influenced a response to
the serious and life-altering infection. The U.S. Centers for Disease Control has failed
its responsibility to protect American citizens from the devastation of Lyme disease,
and yet no one is held accountable. If the Tick-Born Disease Working
Group doesn’t recommend the firing of the [unclear] while leaving
its patients in financial ruin, then we have [unclear] unimaginable pain and
suffering [unclear] Health and Human Services with no ties to the CDC or those named in the
racketeering lawsuit, a Lyme Manhattan project, [unclear] question: Is mismanagement of Lyme
disease a result of incompetence or a collusion? Carl Tuttle, thank you. Coordinator: One thing in,
is there a Bethany Welsh? Carl Tuttle: No. this is Carl Tuttle on this line. Coordinator: Ms. Welsh is not available. Ms. Welsh seems to have hung up. You may go ahead. She was the last of our speakers. One moment please. John Aucott: So, we’re going to transition now from the public comment portion
of the working group meeting. And we appreciate the people
that spent their time and presented their public
comments, and thank you very much. We’re going to transition now to the
discussion from the Public Comment Subcommittee, and Kristen Honey will lead us through that. Kristen Honey: Thank you, John. So, for the Subcommittee on Public Comment, we
formed at the last public meeting on July 24, and we have been meeting the third Wednesday
of each month beginning in September. And since we formed, we have reviewed over
700 written emails to [email protected] And the membership is myself, Richard
Horowitz, Bob Sabatino, and Scott Cooper. And if any of the other working group members
would like to join, please send me an email. We’re happy to have you. This subcommittee is limited to the 14
voting members now, and our charge is you go through all the written emails that we receive
and distill them for working group consideration and translate some of those
into potential actions that the working group might wish to consider. We did, at our last meeting, decide
that we would like to hold off on our formal recommendations to the
working group until the next meeting. And this is because there will be a membership
transition, and we thought it made sense to propose some actions with the new
Working Group 2020 out of the gate, rather than translate public
comments into proposed actions and then have the membership change
at our next meeting with new people. So, that was our general thinking. And with that, I’m just going to go through
high level what we went through and then open it up to Richard, Coop, and Bob to add
anything that I might’ve missed. So, the next slide, we basically, our
commitment to you is, if you took the time to submit written comments, we will read them. And the public input, that high-level takeaway, is similar to what we’ve
been receiving throughout. And really, it’s Lyme disease and tick-borne
diseases are not being fully addressed or sufficiently addressed by mainstream
medicine and government programs today. This warrants increased research funding,
further scientific exploration, and unbiased and fresh review of the latest information from
all sectors, all disciplines, all the evidence. With the report feedback, one thing we observed
is that, after the report was published on November 14, the amount and the tone
of the comments we received changed. And the tone really shifted to the positive. Next slide, please. And we just wanted to kind of give a few quotes. Now, this is not to say that
everything we received is positive. By far, it is not. This is an iterative process. The working group and everyone
has a lot of room for improvement. So, at the top, you know, just some
high-level themes that are consistent. We heard someone allude to it
earlier about grave concerns about the content in the Access to Care chapter. We also had grave concerns about the
vaccines discussions in the report. And then, there were some that were,
like, consistent challenges and comments that we’ve had for a while about the handling
of public emails and just the general process about HHS being responsive, and timeliness, and letting people know about,
you know, what’s happening. And this quote, in the middle, it’s
kind of saying that that leads people to think there might be censorship in
either the written or verbal comments. But at the bottom of this slide, we just
wanted to leave with a couple snippets of some of the positive things that the working
group received, which is brand new. We did not have many positive comments
prior to the publication of the report. So, thank you for everyone who took time to
write in, but on all sides-where we have room to improvement, where there are grave
concerns, the more neutral ones about process, room to improve, as well as the areas
that you think we’re doing a good job. And the next slide, with the process, there
were similarities in the really big calls for increasing transparency and more
opportunities for meaningful public input. And this went from email responsiveness
to website timeliness in terms of publishing the report and publishing
agenda items and things online well ahead of our meetings, so people could have time
to digest them and thoughtfully respond. And then, one of the ideas that keeps coming up is having working group members voluntarily
disclose their conflicts of interest or perceived conflicts of interest. And there are examples of other
working groups doing that. So, our working group has been thinking about
how to turn that into an actionable item and a recommendation for the
Working Group 2020 to consider. We also had quite a few requests for people to make the federal inventory results-the
raw information that the agencies gave to our working group-make
that available to everyone. And many, many people offered to join
the working group or help how they could. And the next slide, in terms of content areas, a
lot of comments still about the need to educate and prevent all tick-borne diseases-even
though Lyme is over 80% of tick-borne diseases in the United States, it is much, much
bigger than only Lyme disease-the need for improved diagnostics,
especially direct pathogen testing; the need for improved treatment options,
especially those with chronic illness; and then to evaluate the role of
tick-borne diseases in other conditions with unknown etiology and really
emphasizing that patients need help now; repeated calls for government to make Lyme and tick-borne disease a high priority-an
urgent priority with federal funding-and a lot of emphasis on the need for patient-provider
partnerships as a two-way exchange and mutual decision-making, mutual
learning for optimal outcomes; and then evidenced-based care policies must be
based on rigorous science, rigorous evidence; and a lot of calls for evidence to go
beyond just peer-reviewed journal articles, but also to the lived experience and all
the anecdotes that are starting to roll up into data, which, aggregated,
can lead to big data. And then the next slide, looking forward. One of the things was inadequate
funding is a huge barrier to progress, and we really need to increase resources. And it’s important that also these new resources
do not pull from other funding sources. So, it’s not Lyme versus other
disease, but it’s all the other disease and Lyme and tick-borne diseases. There was strong public interest to help. Patients really want to be
a part of the solutions. Medical practitioners want to
be a part of the solutions. Researcher students want to
be a part of the solution. We did not receive many comments from
federal officials, largely because, I think, many federal officials who are a part
of this are a part of the working group and not emailing the tick-borne
disease working group. But we did receive emails from state and local
government people who also want to be part of the solution, as well as some
international people who said they’ve worked with different international governments. And strong, strong support for new thinking, new
collaborations, new public-private partnerships, and really a new era for
Lyme and tick-borne diseases. And with the next one, I just want to thank
everyone for taking the time to help, you know, inform our subcommittee and reiterate
that this is a 6-year endeavor. We’re one-third of the way
through, and your feedback, your input is helping us to
make this process better. So, thank you so much for taking the time. And with that, Coop, Bob, Richard, do you
have any quick remarks that I may have missed? Richard Horowitz: No, Kristen. That was great. This is Richard. The only other thing I would say is that
one of the calls out there is, as you said, is really the urgency in that this is a human
rights issue that everyone has the right to proper health care, and that it
has really been blocked at this point because of the politics and medicine and
everything that’s gone on in the last 40 years. So, I would just say that the only other cry
in reading all of those emails was really just to address the human rights
aspect of this and to make sure that that’s included in the process. Kristen Honey: Bob, Coop, anything to add? Scott Cooper: This is Coop. I just want to say, you know, having been
dealing with federal regulations for almost, like, 15 years now, I can’t emphasize
to, you know, the community out there, both to those directly affected, as
well as medical professionals dealing with tick-borne disease, to get comments in,
you know, as detailed as possible, you know. It’s always helpful, you know, with the
anecdotes and evidence-based information because that’s what we do when we do our role,
taking those, we’re looking at public comments, and we have to respond to those,
and we take them very seriously. So, I can’t emphasize how much
those public comments are important to the overall mission of this working group. Kristen Honey: Thank you, Coop. And any words from Bob? Bob Sabatino: Yes. You know, like you said earlier, and agreeing
with Coop, the patient’s voice was heard in this, and as the admiral noted, something
has to be done that is happening right that the comments have come down, I guess,
in their sense of the emails they got. But we did see that people had concerns,
they are addressed, and it’s transparent. You know, there always is room for
improvement, but working together, everyone can achieve some goals
in looking forward to the future. Kristen Honey: Thank you all. And with that, I will pass it back
to-actually, we’re going to hear from Jim Berger, our Designated Federal Officer. And he’s going to walk us through
some of the logistics and process. Jim Berger: Yes, good afternoon. The purpose is basically to give
you the timeline of where we went with the 2018 Tick-Borne Disease Working Group
congressional report and where it is now. On October 1, 2018, the contractor submitted
the final tick-borne disease 2018 report to the Department of Health and Human Services. On October 2 of 2018, the Department of Health and Human Services submitted the final
2018 report to the Department of Health and Human Services Legislative Affairs. On October 6 of 2018, the contractor
submitted the 508-compliant report to Congress, of the 2018 report to HHS. And basically the 508-compliant-just
a quick rundown for you, those that don’t understand
what that process is. It basically, in 1998, the U.S.
Congress amended the Rehabilitation Act to require federal agencies
to make very electronic and information technology accessible
to people with disabilities. It was enacted, essentially, to eliminate
barriers and information technology to make available new opportunities for people
with disabilities and to encourage development of technologies that will
help achieve these goals, so the report can be readily
available by everybody essentially. In October 8 of 2018, the Department of Health and Human Services submitted
the compliant version for review after asking the Assistant Secretary of
Preparedness of Public Affairs to review it. They approved it on October 18 of 2018. On November 14 of 2018, following
up what you heard from the Communications Officer Diane
Gianelli, the report was submitted to the Assistant Secretary of Health and
Congress with the final report provided on the Tick-Borne Disease Working Group webpage. Kristen Honey: Can I just
add one thing to that slide? We are, on the report page of the website,
going to add acknowledgments for everyone who helped scrub in and make
this report possible. We apologize that we haven’t been able to
put them up yet, but they are in process, so please check back because every single person
who helped write the subcommittee reports, every single person who helped
give guest presentations, we could not have done this without you. So, our report page will be updated
to reflect all your contributions. And thank you very much. John Aucott: What happens
after the report is submitted? The report has been submitted to Congress
and HHS Secretary for their consideration. But what happens now? So, it’s really important to understand what
the legislation required of this working group, and what it can and should
do, and what it can’t do. Specifically, the Tick-Borne Disease Working
Group does not have budgetary authority. So, this working group does not have the
power to make grants or to spend money or to implement any of the programs. The Tick-Borne Working Group does
not have programmatic status. Again, it doesn’t have the
ability to create programs at HHS or in other government agencies,
and that’s an important point. We’re not empowered to create
programs or new activities. So, you may ask, well, what does the
working group have the power to do? Well, it was explained to me-and I think it’s
an important way of looking at it-the power of this working group is to create this report
that shines a light on different activities and gaps in research and to
shine the light on things that can be improved that
are gaps in our knowledge. And that’s a pretty powerful business. It allows this report to draw
attention to the concerns and the gaps that people have been pointing out. And by putting a light on it, then, you
know, it sets the stage for the people that do have programmatic
and budgetary authority to do and incorporate the report into their plans. So, it’s really the power to
shine a light on problems. That’s been accomplished. The work of the 2018 Working
Group has been accomplished. The report has been delivered. And so, with that, we look forward to the second
phase-what we’re calling Working Group 2020. That’ll be the group that takes
on the second 2-year program. Their role will be to pick up where we left off. Our first group is not in a
position to tell them what to do. This will be a new group, and they will
have the latitude to bring in new faces, and to address things from a fresh
point of view, and to move forward with new analyses and new recommendations. But this working group will not presume to give the next working group
recommendations on what they are supposed to do. Next slide. So, the next step, actually, is
to create the Working Group 2020. And Jim will tell us a little
bit about how that will happen. Jim Berger: Okay. The public members of the Tick-Borne Disease
Working Group, when we initially started, we knew that there was going
to be three reports. And so, we elected to identify
a 15-month period of service to the Tick-Borne Disease Working Group. We knew that some of the members would be,
would put their heart and soul into it. We’ve had eight committee meetings-it’s
almost become a full-time job for many of the members-and would like to
elect to not serve on the next group. So, we had set that up for 15 months, and what we’re now at- we’ve published the
Federal Register announcement that is put onto the Tick-Borne Disease Working
Group webpage under the Notices section. And basically, you can go to that website,
read the Federal Register announcements, and determine how we’re going to, what the
application requirements are for being part of a 2020 Tick-Borne Disease
Working Group committee. We have a deadline that was set up for it
on December 14 at the close of business at 5:00 p.m. We’ll take the applicants
that have submitted to be on that committee and do a selection process, and identify
those members, and submit those applications through the process for White House approval. And hopefully, by the March timeframe,
April timeframe, we’ll have approval for new committee members to start forward. John Aucott: Thanks, Jim. I want to pause just for a second-we’ve been
marching through a lot of material-and open it up to the working group for any
questions or comments at this point. Pat Smith: This is Pat. I just have one comment. And my comment concerns continuity
from the perspective of the nonfederal members of the working group. And that is concerning because obviously,
you know, many people did put a lot of time and energy into this process with the idea that, since we only really had 8 months
is what it actually, I think, it boiled down to, to present what we felt. We were told that, every step of the way, that
we would have opportunity in the next report to get the things in that we did not cover. Therefore, there were some areas of weakness,
and one of the particular areas of concern that I had-and I think one of our public
members addressed it today-was the issue of the federal inventories. We really had very little opportunity
to do anything about that inventory. There was a small amount of
material that was put in there. It really wasn’t sufficient. Everyone knew it wasn’t sufficient. The time just wasn’t there. And I think that I just raise that because
I feel like you can’t take a process like this-it’s only 6 years to start with-and
then say, “Well okay, now we have some people who are knowledgeable about the process, but they basically may not
be there the following year.” Any of them may not be there the
following, you know, time schedule. So, that’s just my concern. John Aucott: Any other comments? Kristen Honey: One question that I’ve
gotten is how will decisions be made? And my understanding is they’ll be
the same as the first time around. So, Jim, could you just speak a few words about the agencies involved in
selecting the public members? Jim Berger: Yes, certainly. The process that we have-trying to be as neutral
as possible and getting a good selection-we set up a composition of a screening to make sure
the applicants met the criteria that are in the federal register announcements. And once those were identified, the
information was provided to the four agencies that were identified in the Cures Act. In other words, they identified FDA,
CDC, NIH, and OASH as being members. The other three federal agencies were
opened up to the Secretary to determine. So, we started out that process with those
four agencies given the applications. They scored the individuals. The individuals then were, that were identified
were submitted through the process of going from the Assistant Secretary for Health up
through the White House to get the approval. Once that approval process was obtained,
then it was sent to the Secretary of HHS for confirmation and letters sent
out to the selected individuals. So, that process will be repeated. We’ve got a procedure in place. We follow it to the letter, try to
be as fair, as neutral as possible in getting the best qualified individuals. John Aucott: Other comments or questions? Okay. So, we’re going to conclude the
program today with a review of our, kind of, Looking Forward section of the report. Again, the report is not meant to determine
what the next working group works on, but we also agree that there is a
need for some continuity of thoughts. And so, I just wanted to go through some
slides that review some of the possible types of activities that the new working
group could choose to pursue. And these were largely covered in the Looking
Forward chapter of the working group report. So, we’ve talked a lot about literature reviews. There was an informal literature review
that occurred in many of the subcommittees, but one thing open for discussion for the next
working group will be whether there would be more of a systematic type of literature review. AHRQ performs very sophisticated literature
reviews, including analysis of quality of evidence and even types of analysis of
recommendations based on literature reviews. That’s an example of something that could be
done if there was room in the program for that. There were less systematic or in-depth analyses
that are done by the NIH library of reviews. These are systematic, but
they don’t go into the level of analyzing recommendations
and grades of evidence. But these are two examples-they’re not
the only examples of a more formal type of literature review that
could be open for discussion. The second we’ve also heard
about already is, well, which is there will be inventories
again for the second working group. And these inventories would hopefully
occur up in front of the program so that there is more time to analyze them. And the inventories could include both the
types of questions that were asked last time, but also ask for interval reports in terms
of what types of activities have changed since the first working group report. So, those are kind of, two
kind of obvious things that the next working group
might want to consider. The other thing that we’ve
heard a lot about is this idea of public-private partnerships
and collaborations. Also, federal research activities that have
been ongoing related to tick-borne diseases. The last two were brought up in the
meeting, which are (juxtaposed) Item 3: systematic review of adverse effects from
over-diagnosis, and unsubstantiated treatment for presumed tick- borne diseases
juxtaposed with the next bullet, which is a systematic review of the
adverse effects from under-diagnosis and under-treated for tick-borne diseases. So, obviously, there’s still a lot of
important controversial issues left for the next working group to consider,
and that’s a specific example of that. And there was a list of things
that were “put in the parking lot” at the last time we discussed this,
and these are items related… We’ve already heard about nomenclature changes. These have terms like “chronic Lyme disease,” “Post-Treatment Lyme Disease
Syndrome,” “co-infections.” The first working group wasn’t able to put
together a glossary or even attempt to come up with definitions or explanations of these. So, that’s something that remains undone. Other ideas included rise in health care costs
in the U.S. due to Lyme disease and other tick- borne diseases and co-infections,
shortcomings and limitations of vaccine and diagnostic clinical trials, inclusion
of vulnerable and high-risk populations in clinical trials, and the unknowns
of potential transmission unknowns. So, those were listed out in
the Looking Forward chapter. The other thing that was incorporated that
we’ve also heard about is incorporation of patient experiences, inter-conventional
scientific approaches, trust-building, and communication- themes that were important
to our last working group that we have out there for the new working group to consider. So, with that, I’d like to open it up to the
working group for other ideas or comments about things that they think would be important
to have in our minutes today as a legacy to leave to the next working group about
the ideas that we thought were important. I’ll open it up to the working group to discuss. Any thoughts, comments? Richard Horowitz: John, this is Richard. On Point 2 that you had on
rising health care costs, the only thing that I had mentioned before
that I think needs to be looked at is not just when we’re calling it Lyme disease or PTLDS
or tick-borne, but how does this overlapping in other diseases that is costing the United
States billions and possibly trillions. And what I’m referring to is the fact that about
5% of the U.S. population has been diagnosed with chronic fatigue syndrome or fibromyalgia,
which have no good diagnostic testing. It’s by clinical criteria, yet all those
clinical criteria could be Lyme and tick-borne. And that, of course, is what many
of us do see in our practice. The same thing, there are 23 million
Americans with autoimmune diseases. They’ve now been linked up to
both tick-borne infections, like Borrelia, as well as environmental toxins. And I think the notion that we
need to expand this out to the fact that this is not necessarily
a one cause, one disease, which has kind of been the model
of medicine that has existed. But when we start looking at Alzheimer’s, with
46.5 million people with preclinical dementia, they’ve shown that spirochete
bacteria are showing up in the brains of Alzheimer’s patients, as well as
viruses- herpes virus 1 and 2 and 6 and 7. Environmental toxins were published in
the neurological journals years ago. The point I’m making here is I think we
need to expand the discussion, because, if we’re going to keep down rising health
care costs and improve the quality of care of the U.S. population, I think
it’s really important that, when you do this literature review and you do
the studies, you expand it out to look at a lot of these diseases that are now affecting
the American public causing disability. In the New York state alone, you could go on
the New York State Department of Health website. We’ve had up to a 22% disability
rate in New York state. Not surprising, I’m sure some of
that is due to Lyme and tick-borne. But someone really needs to take a
look at disabilities in this country and how the one-cause, one-disease
model-we may need to shift the paradigm at the way we’re looking at this. Pat Smith: This is Pat. I would just like to-this may seem like a
reiteration of some of the things that we did, but I think that there needs
to be a lot more emphasis on getting the true picture of Bartonella. I think that the literature is showing
there’s so many more Bartonella cases, and I know the government has been reluctant to
accept the fact that Bartonella is tick- borne and may be producing a lot of these cases. I think that that question needs to be answered. I think it’s really important because we know of
so many Lyme patients that are getting treatment that also have Bartonella co-infections. Well, you know, if we can’t agree on it, then
we need to find out where is that coming from. Is it coming from ticks? And why have we not done the work
that needs to be done on that? And I think that’s something that
absolutely has to be included. Richard Horowitz: This is Rich again. Kind of building on what Pat said. In my own clinical practice-and we
discussed this in our subcommittee on other tick-borne infections and Co- Infections-we see a huge
amount of babesiosis now showing up. In a paper that’ll be out soon, we are finding
now Babesia duncani released by rhoptries and occasionally by other ways
are showing up, basically, on the east coast in much larger
numbers, and we don’t have good tools to, basically, at this point, cure babesiosis. We’re seeing a lot of persistence in babesiosis
because of resistance to Atovaquone and VitaMax, and most patients don’t tolerate
clindamycin very well. And we’re still seeing persistence. So, I think, when we look at the role of these
co- infections, like Bart, I would just include, also, Babesia, because those two-at least in my own clinical practice-have been probably
the top two that have been causing illness in patients, apart from persistent
Borrelia infection. Rob Smith: This is Rob Smith. Couple comments. First of all, I agree completely
with allowing time for careful literature review going
forward, and I think one of the problems that was encountered this year was the lack
of time to really grade the information or to enhance some sort of system for
saying these are the most compelling, rigorous scientific studies to make this
or that conclusion and these are less so. And I think that if you have a-I don’t know much
about the AHRQ process-but something like that that provides some guidance on the quality
of evidence, that would be important. I think, particularly, the last two comments
both about Bartonella and possibly other species of Babesia begs the question
of our diagnostic tools. How can you be sure that a patient has chronic
Bartonella or a persistent Babesia infection if your tools are not specific
or well suited for the task or have been vetted in a careful way. And I think that, without getting precision
on that side, people would just be led astray. Wendy Adams: Yes, this is Wendy Adams. I just want to comment on the
AHRQ and the literature review because I think it’s really
important to get that read out, and we didn’t have the time to do it this time. But on the other side, I want to recognize
that most of the tick-borne diseases that are treated, or at least in the
later stage-whether you call it chronic or PTLDS- are not treated in academic medicine. And academic medicine is the place
where those studies are created. And, often times, you know, people
are compensated to do those studies or more of their clinic time is
spent doing those kinds of studies. Whereas, you see in the, you know, community
physician population that they’re not, they don’t have the time to do that. They’re not equipped to do it. So, I don’t want to overly rely upon
a literature review when so much of the tick-borne disease patient treatment
that’s happening is happening outside of academic medicine. So, I wouldn’t want to overly bias the findings. I would want to provide some kind of
balance toward what’s in the literature, both in case studies and in randomized,
controlled trials, but also the experience of community physicians who
are still seeing the bulk of a later-stage, you know,
recalcitrant disease. Rob Smith: This is Rob again. I take issue with the idea that
there’s a sharp distinction between academic research and clinical research. As a clinician who sees patients most
of the time and who also does research, I think that there’s plentiful ground for
doing carefully designed scientific studies that are precise and robust and believable
in the settings that are clinical. And I think it’s a false dichotomy
to say that they’re different. I agree that the bulk of the literature
that comes out of academic centers, because people have more support and
time to, and that’s part of the mission in academic centers, but that
doesn’t mean that the source for that information is not
coming out of the community. That’s where most of our patients are. So, I think you still have to go with
where the, where you have evidence. And part of the purpose is to find
out, if you don’t have evidence, what source of studies are going be
most helpful, rather than to conclude to “because I don’t have evidence,
something X or Y must be true.” Wendy Adams: Well, I think academic medicine
and community physicians are set up differently. And yes, there are lots of good
studies happening in academic medicine, and academic medicine does
treat Lyme disease; however, depending on which population you’re
treating, you might see a different balance as to who’s treating the most of
that particular patient population. So, I don’t want to ascribe the lack of, you
know, “rigorous controlled clinical trials” to a lack of people being treated
appropriately in that population. Just because there’s no clinical
trials on that doesn’t mean that patients aren’t being
treated in that population. And this is just a kind of an inherent
problem with tick-borne disease. There hasn’t been money to
study them rigorously. There hasn’t been money to study them really
in many cases outside of academic medicine. And so that’s just a balance. It’s a balance to strike, but it’s
something we should be aware of, understanding that there are good trials,
some good trials that have happened in academic medicine, but that many of
the patients who would be best served by being included in a trial aren’t
necessarily treated or don’t necessarily fall under these rigorous inclusion
criteria that would be required to study them at an academic medical center. John Aucott: It’s good to see that
we still have some work we’ve left over for the next working
group and that, of course, that there’s two more working groups to come. And so, we want to wrap things up now and thank everyone that’s made
this incredible effort possible. It’s really been a privilege for
Kristen and I to work with everyone. It’s been a privilege for
me to work with Kristen. And, I think, just the fact that Kristen and
I shared and co-shared this and work together so well as people that had markedly
different backgrounds, we’ve set, you know, kind of the tone for everyone else, you
know, that we’ve worked with, as well, that we were able to bring together people with
different backgrounds and different opinions. And that was kind of, I think, one of the
huge success stories of this working group. So, I think we’re going to wrap things up now. And again, thank everyone for their tremendous,
tremendous efforts for their collegiality and respect and for showing a model that
people can work together in a positive way and shine a light on the
incredible needs and not to, especially to recognize the
patients that came forward. The patients’ needs, the illnesses
out there that really is compelling us to continue this work and compelling
us to put all of our hearts and souls into helping our patients and our
family members and our friends, and to continue this work
in the next working group. And I just want to thank, personally,
all the working group members. Kristen Honey: Yes, echoing what John just said. Thanks to all the working group members,
everyone who contributed, and the OASH office. Jim Berger who’s are Designated Federal Officer,
Kay Hayes, who’s our alternate, and Jennifer and her amazing team who we could not
have done this report without you. And Sinead, who also was essential in
putting together our federal inventory. So, it really, really was a team effort
and many, many people behind the scenes. And then, how did we get here? I mean, our work is not done. We have 4 more years to go. And so, we have a lot of time ahead,
but this report is a big milestone. And I think our diverse group did it by
focusing on the North Star, and where we wanted to go, and how we would get there. So, I just want to take a moment
and read the values under, that were underlying this entire process. And really through difficult conversations,
very different views, and wrangling a lot of different perspectives and opinions
where we have limited facts and a lot of scientific uncertainty,
we worked through it and came out with a great report, a 100-page report. That is a good first step. Again, not the end-all-be-all,
a lot of room for improvement, but we got here through respect
where everyone was valued. Innovation: We were shifting, and we are
shifting the paradigm, finding a better way. Honesty and integrity: Find
the truth, tell the truth. Excellence: Quality, real-world
evidence underlies our decision making. And then Compassion: Finding
solutions to relieve suffering. Collaboration: Where we work with
citizens and patients as equal partners. And Accountability: The buck stops here. And with that, it brought us to
our shared vision, our North Star: of a nation free of tick-borne diseases,
where new infections are prevented, and patients have access to
affordable care that restore health. Thank you, everyone. Pat Smith: Yes, can I just add to that? And I want to thank you, Kristen
and John, for the job that you did. I know it was-as someone said earlier-I believe
the admiral said it was a Herculean task in general. And I think you guys came together and
brought people together out of diversity, and I want to thank, certainly, my fellow
team members, both federal and nonfederal. And we’ve agreed, we’ve disagreed,
but we’ve clicked. And I think we’ve come a long way to getting
together and going in the same direction. And I particularly want to thank HHS. I know that the task was difficult for them. I believe the admiral spoke very well about
it today about saying all the different things that they never, I guess, expected and how
bringing this diverse group of individuals and opinions together and
how difficult that was. But I think we did a decent job. Was it perfect? No. But I, and I don’t know that the, everyone in the public understands how
cumbersome sometimes the federal government regulations can be, and that is something
which sometimes hinders the process. And it’s not intentional, it’s not
directed necessarily toward Lyme disease, it’s just part of the government process. And so, thanks Jim and your
team and everybody on board. Thank you very much. Jim Berger: Yes, this is Jim. I just wanted to echo what Pat said. The, it was a surprise of the
amount of work that was accomplished by the Tick-Borne Disease Working Group. A lot of diversity-we tried to balance
the working group with different opinions. In other words, we didn’t, we wanted people with
different opinions to give their perspective and so other people at the other side could
understand where they were coming from. And it’s amazing the amount of cooperation
and collaboration that this group did for providing-what I feel and with the Admiral
Giroir certainly feels-as the 2018 Tick-Borne Disease Working Group report is a tremendous job that was put together in
such a short period of time. Can you imagine if we would’ve had the
2 years to do like we, what we would’ve, initially were identified for
doing to produce the report? Eight months, and what you
produced is certainly remarkable. And I thank all of you for your commitment and
look forward to-whether you’re on the committee or not next time-to continue
hearing from you and to serving on whatever subcommittees are identified in the
2020 Tick-Borne Disease Working Group report. Thank you. John Aucott: So, at this time
I’ll take a motion to adjourn. Pat Smith: Vote moved. Group: Second. John Aucott: All in favor say aye. Group: Aye. John Aucott: Opposed? The meeting is adjourned. Thank you for your service. END

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