Tick-Borne Disease Working Group Meeting – May 15, 2018

Welcome everyone to
meeting number five of the Tick-Borne
Disease Working Group. I’d like to welcome
everyone who has traveled in and who is attending virtually and appreciate everyone’s
time and attention. We’re looking forward to
two long days of hard work. This is really the days where
the rubber meets the road and we look forward to
getting a lot accomplished. So I welcome everyone. I’m going to begin by taking
a roll call attendance of the participants. Kristen Honey. Here. Bob Sabatino. Here. Scott Cooper. Ben Beard. Here. Wendy Adams. Here. Rob Smith. Here. Pat Smith. Here. Vanila Singh. Allen Richards. Here. Lise Nigrovic
Richard Horowitz. Here. Dennis Dixon. Here. Kristen Honey. Still here. All right. So we have a quorum and
we will begin the meeting. So we wanted to begin
today with the announcement of our alternate
DFO, Kaye Hayes. So now that Jim Berger is
our formal Designated Federal Officer, um, we have Kaye
serving as an alternate. Kaye has been the
Executive Director and Designated Federal Officer for the Presidential
Advisory Committee on HIV and AIDS since 2012. Before her appointment with the
Presidential Advisory Council on HIV and AIDS,
Mrs. Hayes served as an Acting Deputy Director
and Senior Advisor for Policy for the Office of Women’s
Health within the Office of the Assistant
Secretary for Health. Among her responsibilities
were the formulation of budget, performance, and policy
initiatives for the office; as well as management
improvement and strategic planning. Prior to joining the Office
of Women’s Health staff, Ms. Hayes served as
a special assistant to then Assistant
Secretary for Health and Surgeon General
Dr. David Satcher. She has also worked as an
extramural community liaison for the National Center for
HIV-AIDS, viral hepatitis, STD, and tuberculosis prevention at
the Centers for Disease Control and Prevention, the CDC. So welcome and thank
you so much for serving. Great. Thank you. It’s good to be here. We wanted to quickly
recap meeting four. I believe we’re a
few minutes behind and most people probably
watched meeting four last week. So we’ll go through
it pretty quickly. The bulk of the meeting last
week on the 10th, May 10th, was each of the subcommittee
co-chairs with six subcommittees which were presenting
their reports. These reports were
prepared over several months with 53 subcommittee
volunteers as well as the Tick-Borne Disease
Working Group members. The subcommittees were disease
vectors and surveillance and prevention led by Pat Smith
and Ben Beard; pathogenesis: transmission and treatment
led by Lise Nigrovic and David Roth; testing
and diag… Sorry. That was testing
and diagnostics. Then we have access to care
services and support to patients with Paula Jackson Jones and
Cmdr. Scott Cooper; vaccine and therapeutics with Rob
Smith and Dennis Dixon; other tick-borne
diseases and co-infections with Dr. Richard Horowitz
and Allen Richards. Um, and then also pathogenesis
transmission and treatment and that was with
Wendy Adams and Capt. Estella Jones. So each of these six
subcommittees worked for several months to pull
together a comprehensive literature review and synthesis
into the gaps, opportunities, and potential actions
to be considered by this Tick-Borne
Disease Working Group for the report to
Congress and HHS. This report is due in
December, 2018 and we went through a detailed
schedule of how we go from where we are today with
six subcommittee reports for consideration, a lot of
public input, and an inventory of federal activities
coming in soon. How do we synthesize
that into the report? Lastly, we called for volunteers to finalize our mission
statement which we’ve had several drafts
kicking around since December and hoping this meeting
we can finalize. Next slide. All the subcommittee
reports are posted online; so if you’d like to read
hundreds and hundreds of pages of detailed work that is
available to everyone. We’re also working on making
these, uh, have citations so people can cite
them in their work. The subcommittee
reports are all complete and they are posted exactly
as they were given to us and they include diverse
information sources such as published studies,
information from patients and other experts who
were invited to speak to the subcommittees, and
the experience and expertise of all the subcommittee
members and invited speakers. Going forward, the subcommittees
will no longer meet weekly, but they will still exist
in an inactive status and they will answer
questions and provide input to the working group
upon request. All the information given to the
working group will be provided in writing and made
available to the public through the HHS website. Next slide. [ Pause ] Now, with this next slide I
was hoping to turn it over… We’re going to do it now? Sorry. Yeah. Okay. So before we turn it
over to the mission statement that Bob and Coop
have offered to lead, we’ll just give a quick overview of what we plan to
do here today. The focus of today’s meeting
and tomorrow, two day meeting, is on how this working
group produces the report to Congress and HHS. We are going to begin by
identifying areas of agreement, as well as areas of controversy
or where there’s not agreement that we should highlight
and focus attention on. We also want to identify overlap
and synergies in the content of the subcommittee reports and
we want to discuss the process for how we incorporate
additional sources of information. Two key ones include the
inventory of federal actions. So what are federal agencies
doing in terms of R&D, research and development for
tick-borne illnesses? How much federal money is being
spent for tick-borne illnesses and how many full-time
staff are working on it? And then also, how do we
incorporate the public input? Both the public input and
comments at meetings like today, which we’ll hear from tomorrow,
as well as written email and comments sent
to the HHS website which is
[email protected] And for those of us
watching online and unable to make it today, you
can submit comments 24/7 to [email protected] Um, and finally, for
this meeting today and tomorrow coming out the
other side we will have decided on a process for writing the
report with specific actions, recommendations, and hopefully
if all goes well, divided work and point of contact for
leading the different parts of the report. Now with this next part I
want to turn it over to Bob, and Cmdr. Scott Cooper will
join him soon, but we asked for two volunteers to help
lead with the mission statement and Bob Sabatino and
Scott Cooper both offered. So they’ve been working
the past week to revise and hopefully finalize
our mission statement and as a recap, a mission
statement is different from a vision statement and
that our vision statement is the future state of where
we want to go. Imagine the vision
statement being kind of utopia and the perfect future. The mission statement is
something to be accomplished, but within the constraints of
reality and basically think of it as the present day, and this mission statement
will hopefully capture our core purpose and focus and
ideally would remain unchanged over time. So with that Bob, do you want
to walk us through where we are? [ Pause ] Scott and I concentrated
on it and we took it from a patient perspective
of what was important in our mission and we kind of felt the legislative part
was very important to stick as the foundation and
what a simple summary to bring it together,
and this is what we have as of now that’s still working. “The Tick-Borne Disease Working
Group’s mission as mandated through 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 to the
examined 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 including patients, the family
members, caregivers, advocates of non-profits in
the interest of the patient with tick-borne illness,
scientists, and researchers. A major responsibility of our
mission will be to develop and regularly update the
action of HHS from the past for the present and the future.” [ Pause ] Excellent work. Thank you so much. It is a huge improvement
over our one that was probably three
times as long a week ago. Um, quick question and open
it up for discussion now, um, I noticed in this it says
tick-borne illness as well as tick-borne diseases. For our working group we’re
called Tick-Borne Disease Working Group. Is there a difference in the community whether we
call it tick-borne illness or tick-borne disease? [ Pause ] Or a preference? Pat. I would prefer it
to be tick-borne disease. I think that’s a more
common reference out there. That’s my gut feeling
too, but… And I agree. We just wanted to make sure
we included the co-infection; you know everything in the
gamut that had it covered. But I agree, we could
just use it as disease. We could change it. Yeah. So my one suggestion is if
we replace illness or illnesses with disease, um, there’s
one place towards the bottom, third line up where it
says tick-borne illness. If there are others, replace
that with tick-borne disease, then I would make a
motion that we pass this as our official mission
statement. The first one does say disease
and the second one says illness. Could I just point
out one thing? Uh huh. Um, it doesn’t
specifically reference physicians or clinicians and
I think we have scientists and researchers; so maybe we… I think they’re an
important group to bring in. That actually… That was something
we were working on. I’m sorry it is missed. I agree. With the
representatives, it should be physicians and
clinicians added to that. If we do physicians,
clinicians, researchers or does that get too bulky? Yeah and I think we
could just use clinicians and that incorporates
physicians as well. ‘Clinicians’ is just
a broader term… I see. … for nurses and physician
assistants and that’s the terminology
we used in our report for that reason just because
there’s a broader group. So add clinicians
and researchers and it captures everyone. Agree. So I hear there’s a
motion to replace illness with disease and then add in
clinicians and researchers and then pass the
mission statement with those slight modifications. Any other changes
people want to hear? Then I make a motion that we
adopt the mission statement with disease instead of illness,
clinicians, and researchers. I second. Just a reminder,
if you’re going to… when you talk, use
your microphone please. Alright. We’re ready
to take a vote. Alright. Um, all in
favor say, “Aye.” Aye. Any opposed? Any abstentions? The motion is passed. Nice work Bob. Thank you.
Thank you very much. [ Pause ] And now we’ll turn it over to
our Designated Federal Officer, Jim Berger, for an overview of
the report requirements, rules, and details on how
we’ll get there. Good morning. The 21st Century Cures Act
that was enacted in December of 2016 authorizes the Health
and Human Services Secretary to establish a Tick-Borne
Disease Working Group to serve as the Federal Advisory
Committee. With that there were some
responsibilities that came with that act that we
are closely adhering to. The working group shall no later
than two years after the date of the enactment of this act
– which will be in December of this year – develop
an update, a summary that consists
of six areas. The first one is ongoing
tick-borne disease research that includes research
related to causes, prevention, treatment, surveillance,
diagnosis, diagnostics, duration of illness, and
interpretation of individuals with tick-borne diseases. The second area is advances
made pursuant to such research. The third area is
federal activities related to tick-borne diseases and that
would include epidemiological activities related to tick-borne
diseases and basic clinical and transitional tick-borne
disease research related to the pathogenesis, prevention,
diagnosis, and treatment of tick-borne diseases. The fourth area of responsibility
is identify the gaps in tick-borne disease research. The fifth one is that the
working group meetings required under the paragraph and
the comments received by the working group
are received and that’s the public comments,
for example, that you were able to give during the
meetings, in-person, or provide written
comments when you are unable to provide the verbal
comments during the meeting. The second area is to
make recommendations to the Secretary regarding
any appropriate changes and improvements of such
activities and research and part of that is to solicit from
the states, localities, and non-governmental entities
including organizations that represent patients,
the healthcare providers, researchers, and industry
regarding scientific advances, research questions, surveillance
activities, and emerging strains in species of pathogenic
organisms. [ Pause ] Then part of that, once that’s
completed is the reporting, is to submit a report on
its activities to the House of Representatives and that’s
the Committee of Energy and Commerce and also the
report will go to the Senate and that part will
be to the Committee on Health Education,
Labor, and Pensions. After that is completed the
report will be made publicly available on the internet of the Tick-Borne Disease
Working Group webpage. That includes the requirements
that we will be adhering to before giving the
report to Congress in December of this year. [ Pause ] The next steps that’s
provided is that… through the series is May 15th
and 16th which was the meeting that we’re having now is the
working group drafts content for the report. Next month in June 21st we plan on having another
working group meeting that will be a webcast meeting
that they will draft the report and then in August and September of 2018 the draft
report will be available for agency comments
and clearance. And the agencies that it will be
going to will be the Department of Defense, the Department
of Veterans Affairs, and the HHS agencies involved that are sitting
on this committee. December of 2018, the report
will be submitted to Congress and the HHS Secretary according
to the Cures Act requirements and then at that time
once it’s submitted, it will also be put
available on… publicly available on the Tick-Borne Disease
Working Group webpage. And then in January of
2019, the working group and subcommittees
will evolve over time and HHS will issue
a new public call for the working group nominees
and then planning will begin for the second report. There’s a total of three reports that have been identified every
two years by the Cures Act; the one in December which
will be the first one and then two years later will
be the second and then two years with that will be the third one. Jim, can I just highlight
a couple of changes… Certainly. … from last week? If you can go back one slide. A couple of things to flag
that changed from last week, one is that the June
meeting is going to be June 21st, not June 14th. So definitely flag or book
your calendar for June 21st and that’s final, but an
online meeting, not in-person. And then the other one is that
the public response and ability to see the report will
now be in December. So the public comment period
will begin in December. Thank you. [ Mic Turned Off ] due on August 17th of 2018. The document revisions from those agencies are due
then October 1st of 2018. The final HHS agencies, along
with the Department of Defense and the Department
of Veterans Affairs, clearance will be completed
on November 1st of 2018. The revision and final desktop
publishing will be completed on November 14th of 2018
with the final review for typographical
errors and plus to ensure that it is 508 compliant
will be completed on November 21st of 2018. The plan is to submit the
final report to Congress on December 18th of 2018 and at
the same time to put the page, um, the document on our HHS
tick-borne disease webpage. Okay. [ Pause ] And for the next discussion
of the report template, I’m going to pass it over
to Jennifer who is going to show us what this looks like. The contractors at HHS have
been working really hard to give us a framework that
hopefully will help redefine and reset the narrative
around tick-borne disease and it’s important to remember,
while we’re getting this up on the screen, the audience
for this report is Congress and the HHS Secretary. So we’re gearing this towards
people who are very smart, very busy, but maybe
not scientists and maybe not very
well knowledgeable about tick-borne diseases
specifically and generally with these reports to Congress
the shorter, the better. You know you want to
have it very clear, “What are the action
items to take?” So that was sort
of our framework for this report template and
we’ll walk you through it now. So what we did was… So I’m Jennifer Gillissen
with Kauffman and we’re part of the Communicate Health Team. So what we did was… is went through and
did a lot of research on the different reports that
there have been to Congress. So what we’re going to do is
show you the three major ones that we used to come up with a
report template that we’re going to share with you today. So the first one we
have is the report to the Title XII Congress. Um, it is a more traditional
format for the report. It includes figures that
are more easily understood than some of the other formats. It is similar to another
one that I will show you, but it doesn’t have the same
visual appeal in the format and it’s formatted in a more
dense, less engaging format. So I’m going to show you that. It will take just a
second to pull up. And all of these are
on the internet already so that you can take a look at
them if you would prefer to look at them on your own
you may do so. So, as you see, and I’ll
just run through a couple of the slides, not a lot of
them, just so that we can… that you can see
what it looks like. It’s just a lot of information. It doesn’t really flow. There’s no visual. It’s just… We can’t see it. Oh my. [ Pause ] We’ll… All right, so
here’s the beginning of it. So there’s not really
a whole lot to it. It’s more of just the words
as you see coming down, um, the Executive Summary. It’s just really,
really dense information, but there are some nice
tables that they have in here. And so this is what like
the typical report is that is just reading and reading
and reading and a lot of… but not like a whole a lot of a
visually appealing items here. So the second report that we
have for you to take a look at [ Pause ] is this one here. It says, “Interdepartmental
Serious Mental Illness Coordinating Committee.” So, this one here is
a little bit better. It’s got a little
bit more color to it, but the structure really
isn’t that great for it. Now this isn’t a bad figure,
because it pulls out some of the content, some
of the major pieces, some things that
you can highlight which draws the reader’s
attention to it. So that would be the one thing
that we had taken away from it. The third one is the
“Malaria” report. This one is visually appealing. The information is organized
in a way that is very readable and easier to follow along and they also inter-disperse
images throughout the report. They’ve condensed a
lot of information into a much smaller report,
but you get the information. It doesn’t take a lot
to get through it. They’ve even put in
some facts and figures that nicely highlight
what information they want to pull out. So with all of that,
taking into consideration, working with the HHS
leadership and John and Kristen, this is the report template
that we had come up with. So it has the different images
that would represent, we think, each facet of the tick-borne
disease, including Lyme. When you go through here
it’s a lot of color. We divided up so that
you have your background. You have your methods
and then it goes into different priorities
or sections, however we divide that up. We have the Executive Summary,
but what we also do is we pull out different quotes
throughout the report. So this here is simply… You’re going to see
its all Latin, right. So it doesn’t actually
have the content, because that’s the pieces
you guys are working on, but what we thought is that
it would be easier to read in this kind of format. We would also include patient
as we get a little bit further. You see some of these
facts that we pull out that are nicely highlighted. A couple of these came from
the disease vectors report. We pulled a couple so you guys
could see what it would look like, how it was highlighted. Each section would follow the
same format or in each chapter. We would keep some
of these photos or put in additional ones. We also would take the
patient stories as well as clinical stories or clinician
stories and include them in each of the chapters as
we went along. So however many chapters there
are each one would be included. And so this is if we did it by priority area we would do
something like the “at-a-glance and background” and
then going… explain what that is, doing
the major issues, challenges, including images and graphics
that we could to highlight to grab the reader’s attention, and then provide the possible
opportunities or actions or recommendations that
we would want to have within those sections. We also… If we were to do
tables this is kind of what we were suggesting
tables would look like. That would go through and you
see the public comment and then that would be the
back of the report. Now also, the other part
of this is that, you know, the more succinct that
the report could be, um, the more it’s going to be read,
the more the recommendations or more, um, hopefully
will be acted upon. What we also came up with
was if there’s a subject area that needed additional
explanation we could do what was considered a technical
issue brief. So it would follow the same
kind of format, you know, branding that the report
would follow, but it would go into much more scientific
technical details that could be published
or as part of the report or as an addendum to
the report either way. So this is what we
have for you guys. This is what we were suggesting
based upon all the feedback that we’ve received
at this point. So I turn it back over to
John and Kristen for them to have the discussion
about the report. Thank you so much, Jennifer. That was an excellent overview. One thing I wanted to flag in
there is the different audiences and with the Hill
and HHS Secretary, as Jennifer said,
shorter is better. So we were thinking about
40 pages, but of course, with this type of
report we need the rigor. We need the science. We need the technical
kind of justification. So that’s where the almost like appendices technical issue
briefings would augment the report and would be geared
towards a different audience, probably more scientific,
technical, very familiar with tick-borne illness. And with that I would like
to open it up for feedback and discussion with
the working group. So one of the things that
I think will make it easier as we do this later on today,
we were discussing this earlier, is it would be good if we
could identify how we’re going to condense this down. For example, what are going
to be the major topics? Because as we go
through all the slides, for example in our slides for
other tick-borne infections, we might have four slides or five slides discussing
education. There might be several
on diagnostics. It would be good if we could
identify now what those are going to be because when we go
through the slides we’ll know where to fit those directly
into those categories and that should simplify
the process for later today. [ Pause ] Just in response to Richard. So, we have some
proposed kind of buckets that we’ll be presenting
to the working group as at least a starting
point for discussion about what we call
cross-cutting themes. The obvious ones
being education, but we’ll be presenting
you some to discuss and come up with those. My couple of questions. Minority viewpoints: if
there are minority viewpoints in the report, how
will those be featured? I think it will depend
on a case-by-case basis and it will be up to this
working group to decide how, but one specific example
that we discussed putting it out there was the different
treatment guidelines and we may just want to
acknowledge that straight up. We have IDSA and ILADS, but
potentially in an image instead of having it “us versus them”
and two competing guidelines, with this image and an
opportunity to reframe, we could create space
for a third option that is maybe patient
specific, context specific, or whatever the next set
of guidelines might be and maybe that’s one of
our recommendations is that updated treatment
guidelines are needed. But we did talk about
those differences on treatment guidelines,
but instead of having it “us versus them” in the old way
of one way versus another, is there a creative way we
could look towards a third sort of solution? Well, I guess I’m a
little unclear about that. I get the graphics part, but are
you saying there would not be verbiage that would
discuss the issue? No, not at all. No, not at all. That was just one example. We would think that we
would have to go into depth on something like that and so an
image would just summarize it, but there will be text for both
sides and in something that is that important maybe also
the technical issue brief on the background really
documenting a lot of the science with more rigor than
what we could fit into the main body
of the report. And my second part is about
that, about this whole issue of the report and how it’s
formulated, but it also leads into what the next part
of our discussion will be. And I guess I’m kind of
confused about it, if you will, and that is that the, again, there are specific
recommendations that we’re going to be making to Congress. Now many of these priority
areas, uh, recommendations that are in the reports
are really not germane to what Congress can do. So we have a number of those
and my concern is that if we are to include those, then
that dilutes our pool. It’s always been my experience
with government entities and other entities, if you give
them 20 kinds of things and 10 of them are things that they can
just say, “Well, I’ll just pick up the phone and call
down and tell Johnny that this is what I want, but
I don’t have any jurisdiction over Johnny; so I’m kind of
like, well, you know, okay. I satisfied my constituency. I did that.” Okay. Well, I don’t want those
kinds of things appearing in our report because we
want the things we have. We have, what, 150 priorities
that were sent out there and so the ones that we
finally choose should be ones that are germane to what
Congress actually has the authority to do. Now there’s another
way to address that and that is perhaps some of those priorities sound really
good and maybe there’s ways to reword them so that
they would be something that Congress could
do and I guess it fits into this report template
discussion, because I would like to see at least a
little more, you know, figuring out about how that’s
going to come down the pike because I’m really
concerned about that. I don’t want to give away
our priority actions. Our priority actions
should be substantive and they should be ones that Congress actually
can do something about and that it has an impact upon
our patients, not just something that they can basically blow
off because it’s really not in their jurisdiction. So okay, we have our 20, but
you know maybe only five is something that they
could do something about. So, Pat, let me just
respond to that and I heard like a good approach on how
we might want to filter some of these recommendations or
potential actions down from 150 and it’s not just the impact
and helping the patients, not just substantial,
but also “Are they knobs that the federal government and Congress can
actually turn themselves?” Um, we also had the perspective
that we don’t want to lose a lot of the recommendations that have
come in or potential action. So one idea we floated with
the leadership team was to have an appendix
with all of them, so that way the information
won’t be lost. It will be there,
but then we pull out what are the ones we want
to actually pass on to Congress and the HHS Secretary in
the body of the report. Pat, I would also say that we’re
getting the recommendations from the subcommittees
but the working [ Audio Issues ] Dennis. I have sort of a
philosophical question. I think I have an
answer, but first I want to know what the real
answer is and looking at the mission statement,
there was a focus on inventory of funded federal
activities and, of course, we have multiple years for
this effort and we were limited in the first year and that the
inventory has not officially cleared and been presented
during the discussion we had. And so our recommendations
are sort of ahead of the target in that case. So I have my thoughts
on how we address that, but how are your thoughts on how
to address that in the report of what otherwise could
look like a mismatch? Because we discuss more of
the state-of-the-art overall without respect to point
of origin or funding. Um, so the first response I
have is constantly reiterating that this is a six-year process
and we won’t get it perfect out of the gate,
but beginning it. So this first report there may
be a mismatch, but we can set it up for a more thorough
inventory of federal activities, more thorough literature review, all these different pieces
for the next version. So I think in messaging this
with the public and with our colleagues and peers in
government we have to reiterate that this is a process
and this report in December will be the
first step out of the gate; but we will absolutely update
it as more information comes in and we’re able to do
inventories maybe even with other agencies
in the future. We’ll have to update
and improve I would say. Just to comment. Would the idea be that if it’s
a short report and we’re trying to get a buy-in from
diverse groups in Congress that it would represent
primarily areas of agreement among the working
group where we could all say, “We’re all behind this. These are major… ” And my concern about
getting too granular is that very quickly it
could self-destruct. So I would just put in a plea that we try to keep
that in mind. So you know, it’s
in the agenda today. We’re going to start
with areas of agreement, actually, and I think you’ll… we’ll be surprised
how many areas of agreement there are actually. So we’re starting with areas of
agreement, but then it’s also… We’re following it with
areas of controversy. We’re not trying to say that there aren’t
areas of controversy. We want to acknowledge them, but
we are starting with agreement. We’re then acknowledging
controversies and then as each subcommittee presents
its proposed recommendations – or we can call them
recommendations now, since we’re at the working group
level – you’re going to pull out your priorities and
that’s when we’ll discuss. I’m hopeful that we can
find areas of agreement, at least to start
with, absolutely. Can I make a comment please? Just going back to… I don’t know if it was… it’s initially being
spoke of what Kristen said with the ILADs vs. the IDSA
guidelines in the report. As a patient and for the
public I think it’s important that we look at it to build
the new set of guidelines, whether it’s combining
them, creating the new ones. I agree with the
way Kristen said it. It’s always one side
or the other and that’s not what we want
coming from this working group. If I believe I’m right, we’re
going to propose using those or new ones as we go on. And just to manage expectations,
the scope and, you know, of this working group is not to
create a new set of guidelines, but we can absolutely
recommend that this be looked at and new guidelines be
issued that are more of a hybrid approach that
hopefully can address all stages of infection in all patients. That was my goal, to keep
it from getting thin. Thank you. Yeah, I would like to
address what Rob brought up. I just wanted to
say first of all that certainly I think everyone
would like to be in agreement on the major issues,
but frankly the reason that working group was created and the reason we’re
sitting here is because there have been
differences of opinions and that the patients
have not been represented. Their voices have
not been represented. Treating physicians were not
represented and so their voices and their input are going
to be different sometimes and if we can come to a
consensus as to how to deal with that, that’s
fine, but if not, certainly a minority opinion is
absolutely necessary to ensure that those voices are
put into the report and that Congress
realizes, “Yes, we agree on let’s say I
don’t know 80% of the issues, but there are some
issues we don’t” and perhaps those are the
issues that maybe they need to really focus on
since most likely, although I won’t say all, but most likely those will be
the issues that are important for patients and
treating physicians. Thanks, Pat. I want to keep us focused. We’re in this section now,
we’re discussing the report. I know these were things
we want to get out, but try to direct your
comments towards the report at this point. Are there are other comments about the outline
of the reports? I think the technical section is
really important and I think… So outlining what
specifically should go in there will help us kind
of take the bigger issues and bring them up, right;
because there are a lot of points of technical, let’s
see, diversity of opinion and so how those get
written is really important and then what rises to the top from those will also- will
be really important. So I think we need to
almost discuss those in a separate category
from what’s on the top, the main part. Other comments on
the report outline? Alright. So I think we’d like
to have a motion about which of the three report outlines
you were shown would be a general outline. Again, Jennifer showed us three
outlines that kind of, you know, dense verbiage; the second kind
of a hybrid; and the third kind of a graphics balanced
with language. So there’s three
possible reports. Obviously, we’re not asking
you to vote on the details of the reports, just
the overall look. So I’m open to a motion. So is the motion on
the one that’s being recommended already? If you’d like to make a
motion to recommend the one that the leadership group did, that would be one
possible motion which was option three
or the other options. Okay. So that’s not the hybrid. That’s the graphic. Yeah. Okay. Would it help if
I put it back up? Yeah, would you? Thanks. Yeah. So are you making a
motion or waiting to see? No. Dennis. Before making the
motion I wanted to complement the HHS entity
who produced the draft. I thought it was nicely done
and really caught my attention. So the one you showed
that was the mock-up here with the blue I thought was
very nice and effective means. So the one on the screen is
the one that we mocked-up. This is the one that
we were presenting for review and comments. [ Pause ] So I’ll make a motion to
approve that template. Option three? Option three. Okay. Second. All right.
Any discussion on that? I just have one question. Has anyone looked at what the
effectiveness is of the types of reports that are submitted to
Congress and what is acted upon, you know, in those reports
and if there’s any kind of relationship between that? [ Pause ] So I don’t know if there’s
any sort of correlation or any study or data gathered. That piece I don’t know. Um, I know that the other
reports that we have done and we’ve been involved
in for Congress is that the more eye-catching, the
more information that you have that can be, you know, presented in that way seems to
be more effective. And speaking for the executive
branch, clear, succinct, like three bullet
points, your action items, if that’s what you want to
do is much more effective than a dense text report
and the images we were also thinking could… is an opportunity to update
and redo images in a new way, but then the public and others
could use for other purposes. So we’re also thinking that
the images would have an impact and convey some of the
highlighted messages and recommendations
and that’s often used in the executive branch. We’ll pull images for a one-page
fact sheet, front and back, and if you could have an image, it makes it stick
that much easier. [ Pause ] All right. Let’s vote on option three. All in favor say, “Aye.” Aye. Opposed? Abstentions? All right so option three
passes for the template. Thank you. Thank you, Jennifer and team. That was great. Thank you.
You guys did an amazing job. All right. So we’re going to
move on now into… Obviously, the look of
the report is important, but even more important is
the content of the report. So we’re actually going to
start, Rob, with what we agree on and I think there’s more
we agree on than we think and so we’re going to… This part of this section
is going to be interactive and so Debbie is going to
be taking notes for us. So we’re going to go
to a Word screen and in that Word screen Debbie is
going to take notes for us. So as we develop this list of
what we think our common themes and by that I mean what we
would agree on or important gaps and opportunities and actions. She’ll make a list of
them and then we’ll have that as a starting place
for today’s discussions. So I open it up. I asked your homework over
the weekend was to think about things that we agreed on. So I’ll open it up to the
group to give us some ideas about what we probably
all agree on. Yeah and I just want to point out that these might
be different than what we recommended
in our particular section? Absolutely. Because these run through all
groups as opposed to just what’s on our particular
subcommittee document? Absolutely. Feel free to be novel. Yep. I’d like to think that
there are areas in prevention that we all can agree on
that prevention of disease… You’ve got to speak up. Oh, sorry. That prevention of disease is
often under subscribed in terms of funding and that there are – we’ve heard some excellent
presentations about a variety of strategies for prevention of
disease from both the ecological and epidemiologic side, as
well as – and we’ll talk about this later – the
possibility of a vaccine at least for Lyme
disease and perhaps some of the other tick-borne
diseases. So there’s a general area I
would think we would probably find agreement. And well I think if I could ask,
and so just as a general area of prevention without going into
the granular level of the types, can we just keep it as
prevention to begin with? Yes. So it’s just
prevention or… Well, prevention of
tick-borne diseases. Prevention of tick-borne
diseases. Okay. All right. Good. Um, diagnostics
and treatment. Uh huh. So we all agree… Let’s split it into two. So we all agree on
what about diagnostics? That we need to improve
present diagnostics and we need to improve treatment protocols. Those are actually on two plays. Say that again. Those are all two plays, the
diagnostics and treatments. Uh huh. Does diagnostics
include diagnosis? Or is that… Would you… I mean, so I think
originally when we had started with that subcommittee we talked
about diagnostics and diagnosis. There are two sides, but
maybe of the same coin and I’m not sure if we want
to increase diagnostics to include that, but
that’s just a thought, because they’re linked. In our section, we had included
both those within the same. Yep. I actually find… I’m just going to ask if people
could speak a little more into their mics. Thank you. I actually find it more useful
to break apart diagnostics from diagnoses and
the reason why is because diagnostics is an
entire field of developing tests that have improved
sensitivity and specificity and all these different
types of issues. It’s a whole different sort
of range of specialties. Diagnoses I think,
personally, more along the lines of healthcare provider
education. What is the framework, you know, both clinical and
diagnostic tests? How do these fit together? And I see those personally
as two different needs. Both are important needs, but I
see them as different issues – related but different. And I think on treatment, if
we’re looking for an agreement to begin with, there are
certain areas of treatment where we could probably agree
that there could be a focus and other areas where
we probably disagree. So I’d like to exactly
kind of… As much as we can focus the
statements and still stay in agreement I’d like to
keep it as granular as we can until we hit a point where
it won’t be a consensus. So, Rob, can you give
an example of that? So an example would be, I
would say that the treatment of early Lyme disease does not
necessarily need improvement. That’s an area of discussion. There’s agreement,
however, that for people who have post-treatment Lyme
disease syndrome, we have not… we have an area where we
need to improve treatments and I think there’s,
from what I can see, general agreement on that. I think the area of other
tick-borne diseases, there’s probably agreement
that we don’t even know how to treat some of these diseases
that are more newly recognized and so there would
probably be agreement in an exploratory area on that. So could…
A way to build on that. I don’t agree with
that for treatment as far as it doesn’t… All treatment needs developing, because not one patient
is the same. So you can’t say you don’t have
to change or have a certain type of treatment for new patients
with Lyme or tick-borne disease and also chronic Lyme patients. It’s a totally separate
treatment, but it’s evolving
patient by patient. I could put that at a higher
level that might get away from that and that is if we
just say, “improving treatment” and if we borrow FDA language, “especially how the patient
feels and functions.” Because these three things,
“feels, functions, and survives” and I think that gets at what
you’re really trying to address that is not well
served right now – improving of treatment
especially how the patient feels, functions, and survives. Yeah and we…
Or the individual. We use “restore to
health,” right, in our… I think in our vision statement. So that’s something to echo
here and I would just say on the acute side there’s a
range and I think one thing that we heard in the
beginning of this process is that patients have
been treated initially and sometimes not enough. Right. So I think one thing
to consider is maybe looking at acute, because
there is a range of… There are a range of
protocols that people take to treat those patients
with differing success rates and so I don’t know
that that’s… I understand that
there’s a certain amount that may be agreed upon, but there’s also
some that may not be. So it might not be a
place to focus on it here, but that’s just one… a comment from the… So I think we’re in
agreement on that. However, surprisingly I
can think of a committee where months were
consumed trying to define a healthy
human volunteer. So restoring to health might
mean one thing to one person and something else to another. ‘Feels’ and ‘functions’
seem pretty unambiguous and I think you could squeeze
“restore to health and feels and functions” and that is
an acknowledged terminology within the FDA that
has an advantage there. And was that F-E-E-L-S? Yes. [ Pause ] So I think these deserve
splitting a little bit so we can get agreement. I think we should split
treatment of early Lyme disease which is less controversial,
although it may have issues and split that from what… And here we’re going to run into
a little bit of terminology, so I’m going to use a hyphen, chronic Lyme
disease/post-treatment Lyme disease syndrome for at
least the time being. So we don’t have to go into
an hour discussion about [ Audio Issue ] Post-treatment Lyme disease
syndrome/chronic Lyme disease is an area that we need to look at;
what Dennis was talking about. Yes, I agree. Absolutely. Rob? Yeah, my problem with the
name chronic Lyme disease is I don’t know what it means. Exactly. And I don’t… At least for post-treatment
Lyme disease syndrome there’s like a general definition. That’s right. So that’s my… I think when you… you’re splitting it and
then the question becomes, “What are we really
talking about?” Well, the chronic Lyme disease, it’s from a patient’s
perspective, it’s what I live
every single day. So I could totally
put a definition on it and it could be examined by anyone whether it’s
post-treatment Lyme or chronic Lyme,
my days are hard. So there is a purpose there. I want to keep that… I’d like to really
keep that in there. We may have just identified
a controversy, you know, like something that we
don’t agree on in name or don’t have a clear
definition which is perfect for the exercise we’ll do
after this on differences. Well, I was just going to
say, I’m not sure we disagree. I mean, your experience of the illness doesn’t mean
what we call it is not… Right. Maybe it’s a
different definition to it. Right. And I’m totally
open to have a difference of opinion with someone. That’s fine. But I think we split
that out from early. We can agree that it’s an area
that we all agree needs work and across the themes
we’ll talk about. I’d like to add a category. I think prophylactic treatment
needs to be included in there, because there’s a lot of… I’m sorry. A treatment prior, you know
without having any symptoms. I’m sorry about that. Prophylaxis? Yeah. And so anyway I think
that has to be a category. There’s a lot of disagreement,
because people do not believe in the couple of pills of
Doxy necessarily, you know, doing what it’s reported
to do in certain papers. But we’re on agreements now. So we’re not… We’re on agreements. We’re on agreements. Disagreements is
the next section. Well… Okay, but you said… Let’s keep it agreements. Well, I thought maybe
there might be something that we might be able to agree that we do indeed need
to talk about that. That that needs to be a
category that we address. That would be the agreement. I don’t agree. There you go. It goes to the next section. So if… Robert, yeah. So another one would be
education and access to care for patients and I don’t
know if you want to… I know you want to combine… Put them separate for now. … put them separate
for the moment. So education and everyone
agree that education is… We have a common agreement that
there needs to be more education without going into
the granularity of the flavor of the education? Yes. Uh huh. Okay. And then the second
one you were going to share. Access to care. And access to care and do
you want to say something? I totally agree with
access to care. We need to improve that. I wanted to loop back on
the treatment and think of a third category where
we might agree which is all of the co-infections that
it may not just be Lyme, but the complexity of all these
other tick-borne diseases. So treatment in this
context of multiple diseases and we need better care around
all the tick-borne diseases. Right. I think it’s
important to not think of the other tick-borne diseases
as primarily co-infections because primarily they
exist as single infections and a small percentage of
people may have co-infections. So my concern is that they
not be lost in the umbrella of Lyme disease and get their
due as important diseases that we need to consider
separately. And that came out I think in
Al and Richard’s subcommittee and I think it took a
while to get through that, but we got through it
so that we recognize that there are individual
tick-borne infections but a special side issue is when
they do occur simultaneously or sequentially in a
single individual and how that has its own
special circumstances. Is that a fair phrasing of that? Yes. That’s it. Although I would not agree –
trying to be agreeable early on – but for those of us who
have been in clinical practice for a while actually
co-infections is a large part of my practice. I do see quite a few
patients with ongoing Babesia, Bartonella, and Mycoplasma. We see it all the time. No, I do and I think you
probably have a very specialized practice and I’ve also been
in practice for 30 years and seen people on the front
lines every day, even yesterday. And I would point out that
most of the patients that I see that have these other infections
have just anaplasmosis. We look for the others or just
Babesiosis or just Lyme disease. That doesn’t mean that we don’t
look for the co-infections. So that was my point. And I think, uh… So that will… I’ll put a fine point on this, because I think we’ve
had these discussions that there’s some
tick-borne infections that are the agreed-upon common
ones that occur concurrently or sequentially, Babesia
microti and Anaplasma. I think everyone would agree. Disagree with me if you want,
but I think everyone would agree that those two, Babesia microti and Anaplasma are significant
tick-borne infections that occur simultaneously
and we agree on that. Is that a fair statement? [ Pause ] I’m sorry. That they commonly
agree simultaneously? That they can occur
simultaneously. Oh, they can occur
simultaneously. That Babesia microti and
Anaplasma can occur… Yes, yeah.
But, no, I think… I’m just looking the
epidemiology of… You know we have 600 cases
of reported Anaplasma in Maine this last year. We had 1,700 cases
of Lyme disease. They’re distinct and I think
the issue of co-infection and what it does to the person
who is infected with more than one pathogen is
an interesting area of pathogenesis and work. That’s a little different
than considering each of these diseases in terms
of treatment and diagnosis and I think that that’s
what I’m trying to… the point I’m trying to make. Yeah. So I think we would agree
with that, Richard, right? So I think that’s an
area of agreement. I wanted to put a
fine point on it because I think everyone thinks that with co-infection
nobody agrees about anything, but there actually is a core that people agree
on for co-infection. So getting that down in the
notes, would we get agreement on other tick-borne diseases,
individually and in combination? That would be better. Yeah and I think… So we looked at pathogenesis. This was a key area that we
determined there was no data on and when you look at the patient
registries these are the people who are sick and sign up
for the patient registries that it’s not typically people
who just have a Lyme infection. So that is something to… that really needs to be… You know we have to take that data set realizing it’s not
a randomized controlled trial; however, it’s a large data set
that needs to be acknowledged and kind of considered. Although I’m not sure
that would be an area of agreement among everyone. That’s fair enough, but
from people who looked at the issue that
rose to the top. Yeah. So you’re going to present that in your subcommittee
report I assume? Yes. Yeah, I’m not
sure it’s an area of agreement for this right now. Correct me if I’m wrong. Your mic is still on. I think I have another area
of agreement that was a theme across the subcommittee
reports and that is funding and increasing the
level of funding – federal R&D commensurate
with the scale of the challenge
society is facing. And then there have
been questions from federal agency
representatives whether or not we’re allowed to
make those recommendations, because there are rules against
executive branch employees lobbying Congress and some were
wondering if a report asking for funding would be
considered asking Congress, lobbying Congress for money
and we checked with HHS legal and it’s totally fine. Our report including the
federal working group members in our process if one of
the recommendations is to increase funding we can make
that as a formal recommendation. [ Pause ] All right.
I’ll throw one out. Um, I think everyone would
agree that there’s a need for better data on
surveillance, both for ticks, pathogens, and human disease. I don’t know. I’ll throw it out there
for people to comment on. Well, I mean certainly from the
perspective of our subcommittee, obviously we certainly
agreed with that aspect. There’s some, you know, a
little bit of disagreement on surveillance,
but it’s not for… not about the need for
something new to happen. You know we need some
kind of a new system. This one is broken. It’s not getting the correct
case numbers out there and it’s certainly dysfunctional
in the sense that state to state everything is not the
same or it’s not even close and there’s no way to actually
account for that out there when you’re reporting it out. So, yeah, I would say
certainly that the need for surveillance is… And to capture your point, Pat,
in the notes would people agree with the higher level
of resolution, the need for integrated
comprehensive surveillance? Integrated in what sense? I was thinking across states
and reporting criteria. Oh. Oh, absolutely. Yes. I think we have that in
several, I think, of our areas that people would like to
see something happen and try; though it’s unclear as to how
that can happen with the way that the surveillance is now set up with CSTE doing surveillance
criteria and the CDC having to input into that process, but I guess basically they’re
not totally in charge of it, but I certainly think that some
mechanism needs to be found to do that and I know that, yes, I think our people do certainly
agree with that totally. I think that’s… That’s probably the whole,
you know, root of that problem because what happens
is especially in states where they’re considered lower
risk, that’s kind of being used against the populace there, because they can’t
get a diagnosis and then they can’t
get treatment because they are considered
low risk and often times it’s because of the way surveillance
is used from state to state. Oh, and I just realized… Now I have a question. When I was thinking of
surveillance I was thinking of tick surveillance and that
is a comprehensive integrative approach to monitoring
the ticks and vectors. It sounds like you might be
talking about the disease and tracking the epidemics. Well, because our subcommittee
dealt with human surveillance, believe it or not, even though
the other aspects were the tick surveillance. We did talk about tick
surveillance and I think that everyone was of the
opinion that we needed that. But Ben, go ahead. Yeah, actually we have
recommendations about both of those and I think of them as two different
things just primarily because the infrastructure
and the specialty involved in those are quite different
and for human surveillance which is what Pat was describing
earlier with the Council of State and Territorial
Epidemiologists and all this, I think that all of us
agree that national disease, human disease surveillance
needs to be improved and I think we have
some recommendations or some potential actions
that can address that. I think that vector
surveillance is a separate [ Cell Phone Ringing ] my apologies – is a separate
high priority need as well and so we have other
recommendations for that. But for me it’s useful to tease
those apart and both are things that I think we all agree
on need to be improved. And for the sake of the notes,
would you say that the need for better vector
surveillance and need for better human disease
surveillance should be their own, like, top-level
bullet items? Like, they’re that
different or do you like the sub-bullets like that? I, me personally, I find
them different enough that they should be both
independent top-level recommendations or
areas of agreement. Another topic also that needs
to be addressed is pathogenesis, both early or later since we
sometimes see the downstream effects of these infections and
so I think it’s a broad topic of pathogenesis, but I think
it’s not exactly included in there and I think
it should be discussed. So to make that an area of
agreement, um, let’s discuss that a little bit and maybe
refine it a little bit. Pathogenesis of all
tick-borne infections or certain ones specifically? I would do it for all
tick-borne infections, because I think the other
tick-borne infections and co-infections are
starting to rise in numbers. So we don’t know at this
point the pathogenesis of single infections,
co-infections when they’re together,
downstream effects on the body where you don’t need
antibiotics anymore, but maybe your autonomic nervous
system has been affected. So they’re completely
different categories. Uh huh. So I think the
question is do we… Is there a part of
pathogenesis we all… Right. Pathogenesis
is such a big topic. So is there something
we can all ascribe to or something we can
all agree on? I would say that in our
committee it was the pathogenesis or it was really
the persistence of the organism, Borrelia burgdorferi at least, in animals, in vitro,
and in humans, right. What is causing the
ability of the pathogen to persist despite
antibiotics and/or a competent immune system? So I would say, you know,
mechanisms of persistence that need to be studied. See I would agree that the
pathogenesis of whatever we want to call it, post-treatment
Lyme disease syndrome, we seem to all agree on. My difficulty with
landing on persistence is that it implies automatically
we know or suspect that that’s the cause
of the syndrome, when as I think Rich pointed
out, there are a number of potential hypothetical
pathways that one can imagine. People remain ill
after infection. We see this not just
with Lyme disease. We see it with lots
of infectious diseases where people have post
infectious disease syndromes and it may or may not be
related to residual organisms. Most of the time
we think it’s not. So my concern again
it gets to the area of are we reaching an area of
granularity that is not one of agreement as opposed to “Yes,
let’s take an open mind and look at all of the potential
sources of persistent illness.” Wendy, didn’t you have like a
scheme for multiple hypotheses, though, for the pathogenesis,
not just persistence? Yeah, we didn’t say that path… We said we did not know the
etiology of persistent symptoms; however, the ability of the
pathogen to persist and whether or not that was the cause of persistent symptoms
was important to study. So I would… And it might not be a point of
agreement and maybe we can get to pathogenesis, but that… We’ll get there. I think that persistence
needs to shift to the disagreed section, because persistence
is defined how? And if you’re defining
it by morphological and molecular markers and
not viable culture that leads to difficulties in understanding
given the numerous… We don’t have a good context for
infectious diseases in general and persistence through
visual and molecular markers versus viability in
places we haven’t looked when there is absence of signs and symptoms relative
to where they are. And so cause and effect becomes
complex and requires more study. Put me as a hypothesis. I’ll leave it that way. But Wendy, didn’t you have
three or four hypotheses? To find a common ground
I’m looking for, you know, the pathogenesis may be
explained by one or more of several hypotheses
including persistence, including immune
response, including… Neural dysregulation. Yes. We did have several. So we were not coming out and
saying persistence is a cause of chronic Lyme disease
or PTLDS. What we did say is that
it needs more study and persistence does happen
in animal models in vitro and in humans and we
recite the cases for that. So I think the question
is, “What do we do with that information
and how do we then link that if it is a cause or not?” And again, part of
that was co-infections. You know are these… Is this the cause of
continuing symptoms? Is it immune dysregulation? We go through these; so I’m
not saying that the outcome of our committee was
that we were saying that persistence was the
cause of those symptoms. We were just… We were identifying that
as a mechanism that needs to be studied both in
animals and in humans. I guess. So what I’m hearing is
that we may not get consensus on that unless you include it
as part of a broader package of what needs studied? Yeah. So David, who was
also on our committee, is wanting to chime in. It may be… A better phrase would
be understanding persistent illness. Yeah, I agree. I often think of the common
ground here as an understanding of the ideology or the
pathology of persistent symptoms in patients who’ve had
tick-borne diseases, because it’s not making a
statement whether the organism is persisting or whether there’s
an ongoing inflammatory reaction or whatever, but it’s
the persisting systems that are there and trying to
understand what the cause is of those and how
best to treat those. I agree and that’s where the
value of how the person feels and functions comes into play and understanding the
mechanism of that. [ Pause ] Let’s try again for
something we can all agree on. Is there anyone that wants to try something we
can all agree on? Well, I would suggest what
we agree on is the need for better understanding of
the pathogenesis or ideology or persisting symptoms. After appropriate treatment
of a tick-borne infection? Yeah. We could add
that or just associated with tick-borne disease
infections. Can we agree on that? Yes. I think. We can maybe take up some things in the section we don’t
agree on, but yes. I think this we still
have a starting place and then we can bring up
things we don’t agree with. And I agree with this too
and I just would add to that that we really want to be
careful we don’t close off areas of science by jumping to an
answer and one of the big traps in all of this would be,
“We think we know the answer and we’re going to put all
of our money in that area and I think there’s… ” We’re all in agreement
that there are a number of different mechanisms through
which people can remain ill after infection. Lyme disease is the one
we’re talking about now. We see it in other
infections as well. I think it’s a very important
area of research in general. Building off of that idea of
not closing ourselves to ideas, one other theme I saw emerge from the subcommittee
reports was the need for interdisciplinary solutions and engaging different
perspectives, but really looking at it in a holistic way rather
than siloed and I don’t know if people could agree on
interdisciplinary solutions, and one mechanism for doing
that: leveraging the Centers for Excellence for
tick-borne disease. I think that’s important like
you said and keeping it… Whenever we talk about Lyme
disease we do always use the terms for tick-borne
illnesses or a disease, because all the infections
make a difference and there are all different
protocols and different areas for treatment that we use. Kristen, I agree and
also with big data, you’ve brought it up many times. I think without a
big data approach with multi-center studies
it’s going to be difficult to answer these questions
definitively. So I would just add that in because I think the big data
personalized precision medicine which is where the 21st
Century Care Act was going. I think that should
be included in there. Yeah and I would have big data
be its own top-level bullet and that really rests
on inner-operable data. So you would have to
collect information across research centers and
clinics in a standardized way. [ Pause ] All right. Lise isn’t here so I’m going
to take the prerogative of saying something
for her subcommittee. I think everyone would agree
that we need better diagnostics for the earliest stage of
Lyme disease, specifically, in the first few weeks before
serologic tests are reliable. So I’ll throw that one out. Was it that granular, though? Under diagnosis I
would add that as… That’s treatment. I’m talking about diagnosis
as a sub-bullet; a sub-bullet of diagnosis, because I think
this is an area actually of agreement that we can all
agree on is that the diagnostics for early Lyme disease don’t
perform well and we need better. Do you want diagnosis moved under diagnostics is
what you’re saying? Yeah. Or diagnostics. I’m sorry. Instead of just saying
approved, I’m proposing an area as a sub-bullet there,
a very specific example that gets brought up a lot. Now it’s for acute disease
that the current diagnostics for Lyme disease don’t work well
and we need better diagnostics. And I agree with that. With current testing we
could throw it to the wind and put all the money on
it and it’s still bad. Not saying it’s the worst test. We need more accurate
testing right away. Right, for early disease? Yes. Because I think it
gets more controversial when you talk about
later disease. That’s why I’m making
this point. I’m not sure we would all
agree about diagnostics for later Lyme disease. Chuck. Do you want to add in other tick-borne
diseases at that point or… It sounds like we do. Yeah, that’s a big problem for
a lot of infectious diseases, but that first period where
you don’t have an antigen or a DNA test that’s
sensitive enough. The antibodies haven’t risen. So, yeah. I would include that. Because I think we
all agree on that. I’m not sure we all
agree on diagnostics for later stages
of Lyme disease. I suspect that will be a
controversy is why I wanted to make the point. So John, are you saying
then that there are people that don’t think that we
need better diagnostics for chronic Lyme or
post-Lyme disease? I don’t want to speak
for anyone, but I think they’re
separate topics. I don’t know. It will come up in the
controversy section. Okay. Well, I’d like
to propose the topic that we do need new
testing for others – I’ll call it other
stages of Lyme disease. Okay. So you’ll propose that
as an area of agreement. And I’d like to hope that
we all agree with that. Let’s find out. Um, I don’t agree. Is this a new section? I don’t agree that for say
Lyme arthritis that we need to spend a lot of
our limited resources on reinventing the wheel. We have very reactive tests;
essentially all the bands. You don’t have to
argue over bands. They light up very
reactively in people who have Lyme arthritis
almost down the line. I mean it’s… So I would disagree
that if I were to… had a certain budget
and I was going to prioritize what
I spent money on, yes I would put money behind
early Lyme disease detection and other tick-borne disease
detection, but I would put way down on the list something
like Lyme arthritis or somebody who’s had a
disease for more than a couple of months which is active. So could we possibly… Oh, I’m sorry. Go ahead. So what if we said
that we could agree upon that there is a need
for testing for those who have later staged
Lyme excluding those with Lyme arthritis? I agree. I don’t
know what that means. Still keeping the ability
to have a test for chronic or late stage minus
Lyme arthritis and also newly formed cases
of tick-borne illnesses. And Rob, in terms of what that
means my interpretation is like neurological
Lyme, Lyme carditis, the different manifestations
that may not be arthritic. Well, that’s where we’re
getting in the weeds, because Lyme carditis as we currently recognize
it is something that occurs in the first month to
six weeks almost always after the infection. So when we see people
with Lyme carditis, yes, they may not have a fully
evolved Western blot for example. They’re positive ELISA and
they have four or five bands, but a week or two later
they have all of them. So I wouldn’t look… put that category in
with late disease. If you’re talking about
late peripheral neuropathies with late disease there may not
be a lot of information on that. So I don’t know what
the answer would be. If you’re talking about somebody with a cognitive disease who has
had Lyme disease and is… Then it gets… It also gets… The issue of definitions
come in as to what… “Are we talking about
apples and oranges and what are we talking about?” So we can talk about that, but
I’m just staying and looking for areas of broad agreement,
I wouldn’t dive so deep. I think if we have to exclude
certain things, we’re just going to agree to disagree, because
every one has its own value at that point as a patient. And I think one place
where maybe we could get to agreement is in the specific
case of neuroborreliosis where there are cases
that have been, you know, two-tiered negative
despite the fact that in the CSF you find
antibodies, but the serology, the blood is negative. So maybe that’s a particular
case where particular assays for the CSF might be helpful
in diagnosing those cases that have shown to not show
antibodies in the blood and yet there are antibodies in
the CSF or they’re complex, but there is some
data to show that and that is a particularly
bad case of disease usually and so being able to diagnose
them quickly might be helpful. It may be important to act on
the understanding the mechanisms of how the person
feels and functions with post-treatment Lyme
disease syndrome in order to construct a better
definition of what it is. So I think that that may be too
soon to come to an agreement on what something is until you
fully characterize the spectrum of entities. It’s a clinician’s
opinion at that point. [ Pause ] So this may be controversial
and it may get shot down. You’re going to a
new topic or… Yeah. Um, could we get agreement that we need a patient-centered
approach, an individualized care? I’m again thinking here
like precision medicine and ultimately big
data would do that, but a patient-centered
individualized, you know, need for improved
patient-centered individualized treatment at all
stages of the disease. Thank you. That’s… I was trying
to get to it. I appreciate that. I would disagree. I think that we all want to
be and those of us who are in clinical medicine
patient-centered and being patient-centered has
a number of different aspects. One is to provide the
patient with a treatment that you’re confident is likely
to be effective and to be able to say, “I think this is
a treatment that is likely to work,” and I think
that when we start… I guess I would argue that
precision medicine implies that every time somebody comes in the door there may
be a different approach. Now in an ideal world we will
have our little genetic chip and we’ll have our own sense
of what we react to in terms of antibiotics and what we don’t
react to, but we’re way away from that and although
that might be aspirational, I don’t think that
it’s actually… I don’t think we’re in
a situation analogous to cancer chemotherapy
at this point. That’s exactly what I was
going to say is that you know in other parts of
medicine we are there with precision oncology
where you type the, you know, the human genes,
type the cancer, and it’s a very customized
approach and so maybe we could
come to an agreement on an aspirational thing for precision infectious
disease treatment or something. Because I do think that model of oncology is an interesting
example that we can emulate if we take lessons
learned from there. We might shortcut how
quickly we could get to treating the whole suite
of tick-borne illnesses based on an individual case,
the unique strains, the unique genes, um, instead
of taking 30 years to get from where breast cancer
was in the 80s to today. We might do it in 10. I think we’d have to show
that we really need… That there’s a problem there
that’s big enough that needs to be put up on the board as… at this point and I don’t
think we have that information. I think that most of the
information that I see and experience in
treating people with most of these diseases
is they do very well with standardized
tested approaches; not that we are there yet
in terms of all of them, but I do think it’s a jump to
say that precision medicine… You know we’re dealing with
thousands of infectious diseases and thousands of microbes and many different host
situations whether it be immune compromised and so on. So when you talk about precision
medicine it’s almost… It’s mind-boggling
in that arena. Although, I would say a step above precision medicine are
a formation of subgroups, clinically meaningful subgroups,
and I think we are at the point. So I’d like to throw this out as
a potential area of agreement. I think we are at the
point that we’ve identified at least one subgroup
that has a case definition which is post-treatment Lyme
disease syndrome and that as a subgroup it
doesn’t account for all of what the patient experiences
as chronic Lyme disease, but as a subgroup I
think is one I would like to think we have
agreement on exists and is real and could be approached
as a specific subgroup. So I’m going to throw that out. So the reason… I think the problem
there, though, is to make sure you don’t
over extrapolate based on that very narrow definition and I understand
why the narrow… You know why you have to keep… It’s a subgroup. … it narrow. It is a subgroup and
that has to be… I mean, the problem is, as
you hear, some people refer to everybody with post-treatment
or continuing signs and symptoms after antibiotic
treatment as PTLDS and that is not a correct
extrapolation to that term and so we have to be really
careful in how much we ascribe and how much we want to
study that population when it’s so narrowly defined. Yep. So the reason that
I redefined it myself in our practice with… as Lyme MSIDS is
simply because we found up to 16 reasons
why people are sick and the personalized approach
that we take is as a clinician, if somebody comes in with
fatigue and headaches and brain fog and
palpitations and anxiety, it could be hypoglycemia.
It could be low adrenals. It could be POTS dysautonomia.
It could be Lyme. It could Babesia.
It could be environmental
toxins. There may be more than one thing
that’s causing the same symptoms and if you’re going try
and do clinical studies and you don’t break out the
possible overlapping ideologies and I think that’s
where medicine
in a sense is failing us with chronic diseases is
we’re doing a one call
as one approach model and I think a multi-factorial
model is kind of in that personalized precision
where every patient may come in with things differently. They may not all relate
to Lyme and tick-borne, but still keep them sick in the
long run and our job still is to get patients better
in the long run and to improve the health
of the American public. Yeah. I would just like to
just say, I think at this point that we’re going to have
to agree to disagree, because I certainly disagree
with most of what was said in rebuttal to these
things and I think a lot of us here feel the same way and
I think that we need to move on. I mean that’s what… If it need be, that’s what
minority reports are about and I don’t think we’re
going to get any further, if you pardon the expression,
beating a dead horse. And so that’s my suggestion. Well, I think we
agree with John. So I agree, certainly
with John’s suggestion that post-treatment Lyme
disease syndrome or whatever. If that’s too narrow, then
we could discuss that, but taking that category is an
example of where we want to go to the pathogenesis,
understand the ways in which that could happen which,
once you understand that and have some response to it,
may lead to different approaches
for different patients. So I basically agree
with that concept. But I’m not sure I’m
getting agreement from the other parties here. I disagree with that. I disagree.
I disagree. To the next section. It’s controversies. Okay. Other ideas? [ Pause ] Alright. Well, we’re three
minutes away from our break, so we’re getting close. Oh, I just thought
of one other one and that is leveraging
innovative solutions and I’m thinking here like it
could be emerging technologies. So leveraging emerging
technologies and innovation and this would include
crowd-sourcing, citizen science, prizes, challenges,
all that kind of stuff. So breaking into
new territories. So I would call it leveraging
emerging technologies and innovation. [ Pause ] Any discuss… Is this something we can… we include it with big data? I mean I think this is the 21st… you know the… Is it separate or is it… We could include it with
big data, but I think of it as separate, because
emerging technologies, you know that could also
fall under diagnostics and under the umbrella of open
innovation, citizen science, crowd-sourcing, often the
data collected from those kind of programs is not technically
big data and then also prizes and challenges, there
are federal laws in the America Competes Act that
sets up opportunities for doing that and that doesn’t
necessarily create big data. It pays for performance. So you put a prize out there. “We’re going to award
this if people come up with 99% accurate diagnostics
at all stages of the infection.” So it can overlap with big data,
but I see them as separate. They say that giving us better
partnership and cooperation and goals for people
to work together. That’s a great one. Another bullet of
public-private collaborations. In a sense those are inherent
in the research enterprise, because it’s what makes
people competitive to move to the new technologies
and innovation and even public-private
partnerships are buzzwords within the realm of research. So you’re almost
stating something that doesn’t need
to be called out. The crowd-sourcing is unusual,
but all the other things fit within I think the
standard of routine. I think the question is whether
or not these have been brought to bear already in tick-borne
disease and I would argue that they probably haven’t
and need to be called out here as a place… as a next step for us
to encourage those kinds of innovations to
come to this area. There just hasn’t been the money and in some cases
there just hasn’t… There’s no corporate… There’s no corporate money for
research and development going in where some of those
innovations might be brought to bear.
So I don’t… I think it might
belong here just that it’s something we can
agree it might be helpful in bringing tick-borne disease
research to the next level that say cancer might
be operating at. I’m certainly not opposed to it. I just think it’s
occurring and maybe it’s more so on the basic side
then the applied and the health delivery side. Sounds like an agreement. Alright. We’re going
to go to break. I just want to congratulate
everyone in actually agreeing on some stuff and
also putting things in the next section
on controversy. Honestly, there’s a
lot of agreement here if we get specific
in our language, but there’s obviously
areas we don’t agree on. So, great start. We have a break from 10:40
to 10:50; not too long. So meet back here. We’ll regroup and
start at 10:55. Thank you. I think you can congratulate
yourself in getting us this
far this fast. I was up all night thinking. [ Break ] We’re going to restart
the meeting now. While people are seated I’ve
been asked to make the request that people pull their mics a
little bit closer to themselves, especially for the live
streaming audience. They can’t hear you and they
also can’t hear you unless your mic is on. So the people online
won’t be able to hear you unless your
mic is on and close to you. Alright. So welcome back
to the next section. We’re going to now
transition into some of the controversies… Are we going to revisit the… … or shadowed. Before we do that,
though, Kristen would like to make a suggestion. Well, just talking
to some people at the break I think
folks were thinking about things we agree on. So I wanted to open it up
for any other ideas, um, if people over the break thought
of areas where they might agree on and just also wanted to
revisit what Bob brought up right before we broke, the
public-private partnerships and whether there might be
agreement on advancing that and Bob do you want to
say a few more words? Yeah, if you take what
happened with cancer or research with Dr. Spector or something,
you know, we’re far off from what those diseases have. So if there’s some
sort of partnerships between private-government
or prizes, it could bring a lot
more people to the table. Yeah, we’re only talking about
Lyme and tick-borne diseases, you know, this isn’t cancer. Okay, so where does
the money go? You know they’re going
to look for the cancer. Let’s bring them to
us and be able to have that partnership where, you
know, whether it’s prize level, it’s innovation, more people
come together to work on it. And I know in the testing
and diagnostics I heard from several companies and
industry in the subcommittee where they weren’t going
into tick-borne illness and Lyme disease partly because
comparing the diagnostics to the existing standard
was difficult. So there are barriers for
commercial industry getting in. So maybe one area of agreement for this group could be
catalyzing public/private partnerships that
would be valuable. Is that part of the last one
or is it a separate category? I would put it in a
separate category. [ Pause ] Any disagreement with that? And one other thought I had
at of agreement is reflective of this group and
how diverse we are and how there are
different perspectives; including the patient and
clinician perspectives of the same seat with
academic researchers and government officials and
one theme is that diversity, I think, is strengthening
this group and it may not always be
easy, but I think we’ll get to more robust solutions. So is there something we can
agree on that the diversity and including the patients in
the process is value added? I was going to just… I mean, to what you’re saying,
this is bringing it back to what we had started talking about which was patient
centeredness of the research that’s
done and I think we kind of a little bit got off topic. So I just wanted
to bring it back to that using patient-centered
outcomes which is where the government is going and different research
organizations within the government, um, is to
include patients in the process so that the symptoms
and the endpoints that are used are
important to patients as well as clinicians, right? And it has to be kind of both to
make sure that the patients care about what’s being studied
and that it makes a difference in their lives and that
that’s the endpoints. Those are the endpoints
that are important, in addition to maybe physician or clinician-dictated very
rigorous binary endpoints. And something we’d agree on,
just to synthesize then – I’ll turn to you Bob – would be
that patient-centered outcomes or patient-centered
process is valuable. I just want to say thank
you as the patient. That’s the patient’s initiative
and I appreciate
being part of it. [ Pause ] So one other thing I
would like to see looked at is overlapping illnesses.
Chronic care healthcare costs in this country are
going up tremendously. One of the estimates is 46
million Americans have been diagnosed with a preclinical
Alzheimer’s and according to us there is no answer
right now, but when you look at the scientific literature,
um, there were some issues on environmental toxins. There are issues with Lyme
spirochetes, other bacteria, viruses showing up in
the medical literature, and I think if we’re going to tackle these rising
healthcare costs I would like to see how Lyme and associated illnesses
are affecting other chronic diseases. I think for looking at the scope
of healthcare in our country, looking at 5% of the people
having chronic fatigue, fibromyalgia. Looking at 50 million people
with autoimmune toxins and infections and
this is where, for me, I would like to see it broadened
out, is overlapping illnesses that would help to lower
healthcare costs in our country, and how Lyme and associated
diseases may be playing a role. [ Pause ] Just let me know when you want
me to put something up there. So let’s open that
for discussion. So summarizing what
Richard said, I heard overlapping illnesses
have a role in chronic illness or the burden of
chronic illness. How does Lyme and associated
infections maybe play a role in some of these other
chronic diseases? What is the role in
overlapping illnesses? When we’re just defining it as Lyme disease we may think
it might not be affecting a lot of these other chronic illnesses
that are causing an increase in healthcare costs and I think
that needs to be looked at. Can you say it in terms of
an affirmative statement that we can all agree on,
instead of a question? Um, allocate resources
into looking into the multifaceted
etiology of Lyme and other chronic illnesses which are increasing
healthcare costs in our country. I wonder if we’re moving
away from what we’ve reviewed in our subgroup discussions, into more of just the
novel thoughts coming up at this point. Because this sounds
like we’re moving into other territory other
than what was the main focus of what we did over
the last three months. I think that that
one overlaps a lot with the co-infections report
and some of the patient issues that came up, the outcomes
of the patients and access to care were really discussed. So agree. Uh, some other reports
might have had a different scope, but I think
this falls into it, um, but does that statement “allocate resources
looking into the… ” If you could finish
that and then we can… Multifaceted etiologies of Lyme
and associated chronic diseases. Since some of these may be
Lyme related, as I said, spirochetes have been
found in the brains of Alzheimer’s patients. Why would we be ignoring all of
these people getting dementia in the United States
when we have no answers? I think that’s an urgent
question that needs to be looked at at this point, is how 46
million Americans could possibly be having preclinical
Alzheimer’s and no one knows why
this is happening. Could you explain what you mean by multifaceted etiologies
of Lyme disease? When I’ve looked at… Not multifaceted etiologies of
Lyme, multifaceted etiologies of chronic diseases where Lyme and associated infections
may be playing a role. And I think we did, our
subcommittee, did bring that up in our report about the
burden, the cost burden on the healthcare system
with chronic conditions and as related to Lyme
and tick-borne diseases. So I think it’s not necessarily
a novel, you know, approach. We did look at that,
touched on it briefly. So I think it’s reasonable
to look at. I think we can kind of
agree that it may be driving up costs because of that. Is it a sub-bullet
under pathogenesis? [ Pause ] I think it’s important, Richard. I’m not sure it’s on
the “I all agree” page. When you bring in Alzheimer
it’s a really hot topic button. It’s really, really important,
but I’m not sure it’s on the “everyone agrees page.” I don’t know if people
think that… Again, I’m just trying to
think what page it belongs on. I’m not saying it necessarily
is due to any of these. They’re showing up in the
literature, but just that… since we’re dealing with
tick-borne infections and this has been reported
in the scientific literature, I would allocate resources
into looking at this, because healthcare costs
are rising in our country. Chronic disease is 80%
of our healthcare costs, 70% of the debts are
due to chronic disease and I think that’s something
Congress is looking at and so it might be within
our scope to a certain extent without naming exactly
what’s causing it. So the way you describe
that is almost like we could cut-and-paste
that bullet and put it as a sub-bullet under “increased
funding for federal R&D?” [ Pause ] Sure. And then my last
comment under federal R&D, I believe we left
out prevention. So we may want to have… increase federal resources and
funding for not just research and development, but
it could be prevention, research and development. That’s really all of our topics. Yep. It’s really all our topics. It’s education, prevention,
everything. Right? Yep. Yeah, I talked to John
during the break about that. I realized with the education
it’s not just patient. It’s provider and insurance
and so there is more than just one type
of education there. Simplify, uh, you could just
say, “increase level of funding” and then get rid of the “for
research and development.” Any other things that
we agree on that came to people’s minds
during the break? Can we go back to this… I mean when we have
our priorities. I mean that’s one place
where we might be able to elevate some things
back to this list after all the groups have
gone through their priorities. Yeah. Absolutely. I mean just because we have it down here does not mean it’s
forever stuck in that term, we must use it in the report. This is an ongoing
living document and will not be final,
final until December. All right. We’re going to move on now
to potential controversies and I think kind of the theme
here is we probably could have an endless list of
controversies, but let’s try to think about the
ones initially that are the most
important to address, especially with that goal
we had of looking forward. So I’d like to, you know,
at least suggest that… try to prioritize the
controversies about ones that are the most important and
also ones that look us forward, if possible, as we’re trying to develop a forward-looking
document. So we’ll open it up
to controversies. I would like to say that one of
the biggest controversies is, obviously, the diagnosis
of chronic Lyme disease. [ Pause ] I think that’s a fair statement. And by chronic Lyme disease,
we’re using the broadest kind of terminology, Wendy
in terms of what we mean by chronic Lyme disease? Yes. I think because you have
a group of symptoms for PTLDS and you know how to
diagnose that small group, but we don’t know how
to diagnose people who fall outside of that group. And I think you just touched on
another controversy, is the name and the definition of
this, uh, of all… many of these diseases,
but particularly Lyme. Yeah, because I want to keep…
I need the word “chronic” in there. Say that again. The word “chronic” in there, because for the treatments
they’re all individual and it’s different. The “chronic” word to have it
in there for the treatment, because everyone’s going
to be an individual. Anybody don’t think
that’s a controversy? No, but I don’t see our
controversy listed there. Where it might controversies
the name of a disease or… Diagnosis of chronic
Lyme disease. I would just say that if we
don’t have a clear definition for what chronic Lyme
disease is it’s hard to talk about a diagnosis… diagnostic test for it and
that’s been the issue, I think, from the get-go with the name. I don’t… My own feeling is that
if we get in circles on that it will tie us up from
moving forward in other ways. Yeah, I don’t think we want to, with these controversies,
solve them. So we’re not here to come
up with the definition, but flagging these things
is an important area so in the report we
can highlight them and they’re either need more
attention or maybe it’s funding for those issues and priorities. So the differences, and
I’m hearing the diagnosis of Lyme is one controversy. A second controversy
would be the naming which would include chronic
Lyme, PTLDS, and a variety of different names
that are put out there. And then I guess Rob,
you’re adding a definition of chronic Lyme disease
as a controversy? Is that your point? Yeah, my point is, to my mind,
it doesn’t have a definition, and the post-treatment
Lyme disease syndrome does. Well, I think the definition is
subtly different than the names, because the names don’t
necessarily imply a pathogenesis where you may be getting
more into pathogenesis level, because post-treatment
Lyme disease syndrome for instance is agnostic
to the pathogenesis. I don’t know. It’s post-treatment. I will channel one person on
my subcommittee who would say, “we don’t know if
it’s post-treatment. We don’t know if it was
just insignificant… insufficient treatment.” So… Yeah, so I think the
controversy envelops all these issues, but it’s clearly
a key controversy. But it’s one that we’re called
to, you know, to address. That’s right. [ Pause ] Chronic Lyme disease. Other areas of controversy. The obvious one of course
is persistence of Lyme and associated tick-borne
infections and the role in post-treatment Lyme disease. And by persistence you mean… Ongoing active infection. All right. Clearly a controversy and
that would include, I guess, both people that haven’t
been treated and people that have been treated
with some element of antibiotics.
Is that true? Sure. Just to broaden it out. Sure. Also, I think a major
controversy is the surveillance definition of Lyme
disease and basically how that definition has
been commandeered to be used almost exclusively
for diagnostic purposes. Uh huh. Correct. [ Pause ] I’m sorry. How it’s been used for, what? Diagnostics. Okay. Thanks. [ Pause ] Diagnosis or diag… [ Pause ] It would be diagnostic purposes. [ Typing ] Is it a controversy or not? Maybe I’m jumping ahead of
the need for a vaccine for – I think it’s pretty
controversial. I said a vaccine. It
was just on my lips. I was just about to raise it. Is the controversy over
the need for a vaccine or over the ability
to get there safely? I think it’s the later. Because I think that… It’s hard… Yeah, okay.
I’ll leave it at that. I think, Pat, you’ve
said that before, right? Would you agree that it’s not
about the need for a vaccine, but the ability to get
there safely and… Yeah. I think it’s
the need for… The need for a vaccine
is probably there, but I don’t think there’s
any agreement on whether that should be a human vaccine, whether that should
be a tick vaccine, or whatever else might be out
there in the vaccine world. I’m not sure there’s
agreement on that, but I think that people
would feel that probably one of those types of vaccines
might be something they would like to see. Although that’s not
universally accepted, at least from the comments
that I’ve received? Probably not, but then again, vaccines are not
universally accepted. So it’s hard to delineate, you
know, that, but I would just say that the biggest concern
I think is driven, and if I can interject it here, the biggest concern I
think right now is the fact of the OspA vaccine that
has been fast tracked and I think that’s a big concern
due to the fact that, you know, the science in a lot of people’s
opinions has been unsettled as to what happened with
the prior OspA vaccine. So I think that kind of
clouds the whole picture. [ Pause ] Could we say that
the best approach to a Lyme vaccine
is the controversy. Because then you get at not
only what the target is, but the way to get there. Are you saying, “human vaccine?” No. I’m including
humans, reservoir hosts, and tick targeted antigens
all as an approach. Okay. I’m trying to think of
an umbrella term that gets away from disagreeing over
the utility of a vaccine to disagreeing to
the best approach
to a safe and effective… I would say it’s approach
and allocation of resources to a vaccine, and where
that falls in the spectrum of disease research
that’s going on, and how it gets prioritized
is part of it. Yeah, I think that sounds
like that might be an area of controversy, because my
mantra is the mainstay of tools for infectious diseases
are diagnosis, prevention, and treatment based and we
have some form of diagnostics and some form of treatments
and no available vaccines. So it just seems unfortunate
to eliminate the potential of vaccine given the untold
benefits that it could serve in preventing new diseases. It doesn’t help existing
disease or may not. There are some therapeutic
vaccines. So I think that it’s
hard to argue with that having
a high priority. Particularly I’d say… To follow up on that with
concerns about the total burden of disease; the more
you look at that, the obvious in the best possible
world, the obvious answer is to prevent disease
completely, and we’ve talked about ways you can do
this in your backyard, but if there were a safe,
effective Lyme disease vaccine that people could
use, why wouldn’t that be something
everyone would agree on? I think maybe… I’m looking… Is that Dennis? Did you see your
statement on screen there? No. Is that what
your statement is? That’s the working
draft of it right now. Yeah. Well, that’s what I meant. And also reservoir
host he also said. I think perhaps – and I
don’t know how this could be incorporated – but one
of the biggest issues with people is quite frankly
the transparency process with the last vaccine
and I think that that would somehow
maybe need to be addressed in this issue. I agree with the transparency and I think it goes
beyond just the vaccines. So I would have transparency
into this whole process or transparency into government
process be its own bullet and maybe vaccines a sub-bullet,
but you know our working group, obviously there’s been public
calls for more transparency. Remember when we presented
data on transparencies? Overheads. And looking back on the notes
from where we were supposed to agree, but we
disagreed on prophylaxis. I think that we could
generalize that and say treatment guidelines
and then have a sub-bullet under it that’s prophylaxis. I’m sorry. Could… Are we off
of Dennis’s bullet? Because I didn’t know
if we were finished that discussion or anyone had… Oh, I thought he said
it was a working draft and we all disagreed that… Or all agreed that vaccines
were a controversial area of disagreement. Okay. Do you have additional
things to add to it, Pat? Maybe, but I don’t think
we have enough time or room on the screen. [ Pause ] And I feel like I might
get shot for saying this, so I think that’s
probably an area of controversy, but
transmission. I do think there’s more research
needed into transmission of all these tick-borne
illnesses, but particularly for Lyme. Is it only ticks, you
know, and human to human? I’m sure you’re including
sexual transmission? I would… I’m a little confused as to
what our process is here. Are we just trying to list
all the things that have come up in the reports that
might be controversial? Yeah, things that we think would
hang us up and that we may be, given this date of
today’s research, we’ll not be able to agree. So it’s like, “can we
agree to disagree?” but flagging them now, because
what we’re envisioning is that some of these topics
are probably going to have to have the technical addendums and we’ll dive in
deeper for them. But are you implying
that they all have to be addressed the first
round in the report? No. Not in the first
round and at the end of day two tomorrow we’ll
actually have the afternoon to go through what we’re
calling the parking lot. So we’ll flag some of these
things and over the next version of the report dive in deeper. I think that would be good,
because Wendy made the point… used the word prioritize and
I think we do have to keep in mind ultimately we’re going
to come down to priorities. In fact I think Wendy’s
group, you flagged the name for the illness as something
that probably wasn’t going to get addressed in
this report, right? I think we flagged both that
and frankly transmission, because we couldn’t go… we couldn’t study that. It’s such a big topic
and we felt that we couldn’t do it justice. So we wanted to do it… We wanted to suggest that it
be done by the next group. So maybe to capture
that next in names and transmission research we
can do ‘parentheses’ parking lot for both of them. [ Pause ] Going big picture and you
use the word prioritization, I would say prioritization
of funding. [ Pause ] I would just add with
under transmission, apart from sexual human
transmission that you discussed, Bartonella transmission
by ticks, because that was a big
controversy that came up within the groups, too. I’m sorry. Could you repeat that? Oh, um, the transmission
research was from human to human transmission, but also
transmission of co-infections such as, “Is Bartonella
transmitted by ticks?” [ Pause ] And then with the
transmission we’re also looking at other insects, also:
mosquito, fly, gnat, bedbugs, stuff like that. Money allowing. Noted. [ Pause ] So I think we want to
keep the parking lot next to transmission research. [ Pause ] I don’t know how to put
words to this, but it’s more of the human dimensions
and the social dynamics that have surrounded
Lyme disease for decades now,
like the Lyme wars. It’s a controversy and how
do we move beyond that? Um, so I don’t know. Maybe we just write “Lyme wars
and the human dimensions.” But I think we should
head-on address some of that in the report. Yeah, I mean sometimes
people take positions to win the war instead of taking
a position to advance the field. Uh huh. [ Pause ] Are we saying it’s a controversy
to move beyond the Lyme wars? It is depending how you do it. I mean one thing
I’ve heard from a lot of scientists is they
don’t want to investigate, particularly Lyme disease,
because it’s so politicized and they’ll get arrows in their
back and they’re scientists. So why would you
subject yourself to the public scrutiny
and the attacks? They just don’t, and I think that prevents our field
from moving forward. So how we move forward I
do think is controversial, because I think there are a
lot of great actors and players out there who believe
their intentions are great. They’re moving the
field forward, but there are different
styles and I think some of them have clashed
and, um, yeah. So I think… I don’t know how we
frame it or address it, but not acknowledging that and those controversies I think
would be a missed opportunity given the diversity
of this group. Yeah, from the patient’s
side it is moving, because it’s hard
sometimes to see the end of what the achievement is
going to be when you’re living through it at the same time. So you could… It is acknowledgeable to say,
you can understand sometimes that people look at
the short version of what we’re doing today for
what it’s affecting today, but we’re really looking at
what it’s going to affect down the line once the report
could come out and be published. Also, to what you said
Kristen, I think that part of that disagreement in the
Lyme wars and how it’s settled or worked through is the fact that quite frankly I think
our peer review system in our country is broken. I think it’s broken at every
level, including the awarding of grants, including the how
peer review literature is reviewed, and I think that that
has worked to the detriment of patients significantly and I believe it’s
prolonged what has happened and prevented new ideas
from being looked at and new science from
being looked at. People were pushed
out of publications. They weren’t awarded grants. Peer review refused to review
those grants often times. And the scientists who did
speak out often times were kind of pilloried by their own peers. So I think that’s
problematic and as you said, we have to find some way,
but it can’t be excluded. It has to be… You know it has to be pointed out that this is
what has happened and contributed to
the situation. So a second bullet there would
be the grant review process. I’m struggling to figure
out the higher-level bullet, the acknowledging
and moving beyond. Are we trying to say we disagree
that there’s disagreement? That’s what it… That’s what I thought
we were trying to do, find areas of disagreement
and that almost translates to “we disagree that
we disagree.” So maybe it’s a matter of how
we’re framing the bullet point that I’m struggling
to comprehend. [ Pause ] And maybe something like,
“we disagree on which side of the Lyme war is correct.” [ Pause ] Because there really
are often two camps. If we don’t agree on how
to move forward then… Yeah, I think that’s
the way to frame it. “Don’t agree how
to move forward,” because I think that’s
our challenge now. Agreement on how, yeah. Yeah, agreement on how to
move beyond the Lyme wars. Yep. [ Pause ] Does everybody know
what Lyme wars means? Or could we say something more
operational, “don’t agree on how to move beyond disagreement.” Or controversies. Or controversies. I like that more
than a media term which is how I would
see Lyme wars. I think make it understandable
to anybody. [ Pause ] And also that sub-bullet
about the peer review system, “to regard to research
and publication.” [ Pause ] And was grants another one? [ Pause ] I’m sorry.
I’m still grappling with this. Does that mean by having
this peer review thing here that we don’t agree that
the peer review system is worked against? Correct. Okay. I hear that a lot
from people that like in the academic world
people think it works well, but from clinician side, patient side you often get
rejected from the elite journals and then that information
is not included in the broader discussion,
you know, with government and
academic groups. So I do think that having
debate about whether or not the existing peer review
system is optimal is a healthy area of debate and
then same with… I would actually
put a second bullet of the grant review system,
because I know many academics and government, we think that the grant review
system is rigorous, based on a merit-based thing, but
again, the same dynamic talking to patients, talking to
clinicians who have not broken into that system,
it seems challenging and from the outside
may be broken. Well, grant review and
peer review are synonymous. Um, I was thinking of peer
review for getting into journals for the publication of
scientific journals. Oh. Okay. And then grant review
for the awards to do the research. Okay. That’s helpful
to articulate. I actually would just add that I think actually you
can get almost anything into a journal these days. There’s so many journals out
there that one of the challenges for anybody is vetting
the information that’s made available.
How good is the science? How rigorous is it? You know those are key questions that we may lose
sight of as we… We can publish all kinds of
things, but is that going to be really helpful
and move us forward? I think quality and rigor
of science is an
excellent top level bullet, because I think it also comes
up with the crowd sourcing and citizen science
and criticisms about how reliable the data
are if it’s not a random sample and that kind of stuff. So quality rigorous science
is a high-level thing; I think is a healthy
area of debate. Is that a separate line? [ Pause ] So, and I think that matches
to the grant review process, because sometimes the most
innovative ideas aren’t getting past grant review and
therefore they’re being done without sufficient
funding and then you get to the journal problem.
So I think they’re linked. [ Pause ] And one of the topics that came
up on diagnostic testing is how to evaluate or understand
different laboratory testing labs. You know which labs
are at what level or how is that even determined? So just kind of laboratory testing in general can be a controversy about which labs are
the best labs to use. Yeah, I would agree
strongly with that and also just using
assays that… developing assays
or using assays that you know are
not point-of-care, because antibody levels
aren’t there, but to go ahead and develop them or
sell them for company or personal gain
I find disgusting and so yeah, controversy. And that’s not limited
to tick-borne diseases. I know that there’s a
general controversy in general about laboratory-based
test in all fields, right. [ Pause ] Can we include in
there that the… something in that
bullet about the… Because we’re touching on it,
but the CLIA approved labs, because quite frankly many
Lyme disease practitioners, the ones who treat actual Lyme
disease and chronic Lyme disease and so on, you know, they
find that the, you know, those tests are more innovative
than the tests you find that are FDA approved or cleared
tests and so I think that’s part of the problem and of
course, the FDA had something on the docket to move, you
know, the CLIA approved tests into under FDA authority, if
you will, and I know that… I believe that that’s on
hold at this point in time and that’s very problematic
to Lyme patients and treating physicians,
because it stifles innovation. If you’re going to do something
like that there’s a lot of innovative tests, tests that
include perhaps more strains, for example, with the Lyme
bacteria or you know perhaps with other tick-borne
diseases and things like that. I don’t know how that
gets exactly incorporated, but I think it should
be mentioned some way. [ Pause ] Does that bullet capture
what you were saying, Pat? I think so. Yes. Thank you. One other area of controversy
is insurance coverage or just insurance. I think that gets back to
the diagnostics and all, but it cuts a couple of
ways from what I’ve heard. One is, obviously getting
your health insurance covered, but also people who are told
by health insurance companies that they do not have Lyme are
told by insurance companies that they can’t get
life insurance because they do have Lyme. So, just insurance
coverage and the issues around the route
back to diagnostics. Yeah. We’ll touch on that with
ours, because it comes to access of care and treatment
and individuality. Can we talk about how that
might be controversial? I mean, is there… Are there people who don’t
believe that insurance or that, you know, that that
should be controversial? Yeah. All the insurance
companies who review that you do not have
Lyme disease and care is denied,
that’s controversial. Every patient who is fighting
for coverage and it’s denied. Yes. So, but is that a
controversy among this group? [ Pause ] I mean, does the group broadly
agree that there are a lot of particularly Lyme patients
or maybe co-infections who rightfully should
be treated, but their medical
care is not covered? I wouldn’t be able to
answer that myself. I just don’t have the
data to answer that. Absolutely. Not even a question. Yeah. It goes to criteria with
testing; when a patient has to qualify to have
certain bands with a test. It all goes back to the testing,
but still on the patient for care with the insurance. Was that a topic
that was discussed in any of the subcommittees? We didn’t address that. So I have nothing to add. Yeah, we did and I… You know it’s one of those
things that I think goes back to the treatment guidelines,
the diagnostic guidelines, you know, the criteria used. So it kind of folds back
on other controversies, um, and kind of flows forth through
that, which we kind of saw as, “If those issues get resolved
the insurance will follow coverage,” hopefully. But I think the fact,
like Kristen said, that you’ve got issues where
they’re denying you have Lyme on one hand and then
denying insurance because you have Lyme
is controversial. I mean that’s just crazy
to have that paradox. So, yeah I think it’s
reasonable in that regard. [ Pause ] I think we’re saying that
there may be some controversy that relates back to what’s
the diagnosis of Lyme disease which we already agreed
was an area of controversy, particularly chronic Lyme
disease, is that right? Yeah and I think some of
the controversy could be, “What do you do around that?” So at a Mid-Coast
Lyme Disease Support and Education Conference two
weeks ago a representative from Maine, a Republican,
stood up and said that the government
needed to pass a law to force insurance companies
to cover this and that to me seems controversial,
but maybe it’s something that we want to address
head-on in the report. [ Pause ] One of the other
issues is who is going to do the educational component? That’s definitely
controversial, of which group.
Is it HHS? Is it CDC? Who’s actually going to be
putting out the recommendations? We discussed that
a bit in our group and that was something I think
that needs to be looked at. Would that be something we agree
on rather than disagree on? I mean I’m still
struggling with the rationale for identifying things that
there are controversies on the working group versus controversial
topics in the field. I mean we might all agree that
this is something that needs to be fixed and then it wouldn’t
be an area of disagreement. Well, but Dennis, the
only problem I see with that is I think
that the reasons that the insurance company
are doing the denial; for example we’ve had
patients get stuff back from the insurance
company and says, “You don’t meet the CDC
criteria” – exact wording, okay and so on –
“for Lyme disease, so therefore we can’t pay.” Or, you know, “That’s
not Lyme disease. You don’t really have a
definitive Lyme disease diagnosis because you have
X, Y, and Z. That doesn’t fit into certain guidelines
that are out there.” So that’s I think the
problem that it’s the genesis of why they’re doing that. And in terms of framing what
Richard said about education in terms of a controversy, I
heard him say, “Who is going to be doing the educating?” And another angle of that
might be like with CMEs and how to educate doctors and right
now it’s not a big part of medical training. That seems controversial, how
to bring it in, whether it’s who does it or how
to bring it in. Right. It’s a “who and what.” Uh huh. Yeah. Yeah, with the education,
it’s a… It will be a cross-platform
so that providers and CMEs are getting certain
information, but patients that are getting educated
getting the similar information, you know, made for
them to understand. So, there’s one standard
across the field. I was just going to say that
actually from the medical sch… We were involved in
medical student education
and residency fellows and actually I have noticed a
marked increase in attention to tick-borne diseases in the
curriculum and actually we’re in an endemic area so it
may be biased by that, but the knowledge base for this
has gone up quite remarkably. So I just make that as an aside. If I might follow up
with a different… I don’t know if we finished
that line of discussion, but I was going to say,
there clearly is an area of disagreement over treatments
and patient safety and that some of us believe the treatments
that are not well vetted or have not been well studied
provide or cause more harm than benefit for patients. I think at that point that’s where we trust the
clinician that’s prescribing
that type of treatment. I think in our subcommittee
we talked about the need for patient partnership and
partnerships of physicians and patients to discuss
what treatments are best and that patients have
an ability to put input into that decision like it’s
done in prostate cancer. So that might be a place
where there’s disagreement on how tick-borne disease… how that should… how the partnership
should be incorporated, but it certainly an area we
flagged as needing to improve. I think a lot of that with a physician-patient
partnership comes down to, “what’s the information basis
that you’re operating on?” If you’re… Like me, if you’re organized… if you’re putting in an order
for a PICC line for someone to receive a month of IV
antibiotics, you have a sense from your training and
your experiences as to “what’s a safe indication? What’s a good time to do this?” And when you talk to the
patient you can give them that perspective which
they can accept or reject. One of the problems though
is patients are dependent on their physician or provider to provide the baseline
information and guide them in that decision. Now some of us are
concerned that that side of things is a potential
area of risk for patients. And I would almost… I agree with you on some
parts, but disagree in others and one area that I disagree on
is, yes the clinician’s role is to provide information and to
give the best science and give that state of information;
however, there’s another aspect to patient partnership
and that is the individual risk tolerances. Not all patients
will be the same and some may be more
risk seeking and willing to try more aggressive
or uncertain treatments where others are not and
that needs to be factored in and I would argue
right now it’s not. But how to do that I
think is very contentious. And I do actually agree
with one thing that Rob said and that was that
the training… I just thought I would
bring that up just in case. So anyway, that the training
and experience of a physician, which he alluded to as
far as IV’s etc., is very, very important in what you
communicate to your patients and I will state that our
treating physicians have actually been treating
Lyme now for decades when other physicians
would not treat them. They have a vast
amount of experience. They are extremely
knowledgeable about the science; not only that, they actually
have guidelines that appear on the national guidelines
clearinghouse, and they’re using
those guidelines to make clinical judgments
to treat their patients. So I think that they’re
extremely knowledgeable. They’re able to articulate to
their patients what the risks and benefits are and believe
it or not, a good percent of Lyme patients
learned that they have to be their best advocate, because there’s not someone
there advocating for them in too many places
in our country and that’s pretty disgraceful,
but that’s another whole topic. But anyway, the bottom line
is the treating physicians are very capable. Does that mean there are
individuals on both sides of the question who may
not have that ability? That I think we probably
could all agree to, but our physicians
have done a great job of getting our patients either
back to a state of health or at least progressing in that
direction and they have done it in partnership with
their patients. I like what you said to Rob. Um, also you say the patient
should know what they’re doing. Now I trust the clinician, but also in this community
Lyme patients are very informed of treatment protocols and what
works and what doesn’t work and it’s just patient
A, B, and C are going to totally react different
to a cyclo-doxy and that’s where it becomes an individual – and as patients we
do the research. Should we have to? I don’t think the patient
should have to have that much information, but
in this community we do. And then to work with clinicians
that are able to provide that type of care is very
important and we learned. We talk. We have
that conversation and it just brings
it more forward that the treatments are very
important per patient base. Yes. That’s an important
point and I think that what all physicians
are trying to do with their patient is to
provide a risk and benefit menu, if you will, of options and for
many things the risk-benefit is pretty clear. So for me to prescribe
a course of doxycycline, a standard course of
doxycycline, which for somebody who has erythema migrans
rash is a very clear decision and it’s easy to
communicate that to a patient and it’s also a low
risk decision. Once you get to more complicated
treatments than I think it is… It’s putting a lot on
the individual to sort out the further you get
a field from what’s sort of mainstream infectious disease
practice with antibiotics, for example, or use of IV
lines, that’s where you get into territory where it’s
very difficult to figure out, “What is the risk-benefit?” Not that an individual
doesn’t have the opportunity to make their case for why they
think that would be helpful to them, but somewhere along the
line it’s the physicians duty to provide their own opinion
as to whether that’s a useful or a risky way to go,
and certainly in the area of Lyme disease there
are a large number of treatments that
have not been… We don’t even know
what they all are. I mean I hear stories from
people of incredible… to me incredible treatments
that are outside of the norms of what we know about in most
of modern medicine and so, how do we respond to that? And I think actually the
service sub-report… There was a line in
there about dangerous or extraordinarily
risky treatments. So I think that probably
was discussed. Yeah. I was thinking, I think
this is probably the controversy here, the disagreement, the working group is
maybe distinguishing, “What are alternative
treatments, alternative to, you know, the IDSA guidelines
for treatment all the way through varying, uh, where there
are things you haven’t even heard of yet and could be
extreme, could be dangerous, could be exploiting patients?” So it’s trying to
distinguish between, you know, what’s clearly in alternative
and reasonable approach and what is really far out
there and is dangerous. Well, I would also like to say
that what I see is dangerous and it’s not often brought up,
but it’s very dangerous to me that tens of thousands of
patients in our country who have had Lyme disease, have
Lyme disease, whatever word, tense you want to use there, and
continue to have these symptoms after a short course
of antibiotics are sent to psychiatrists who
then prescribe all kinds of medications. Now I don’t think there’s
anybody that can say that those medications
aren’t dangerous. Now is that… Does that mean to say that
there aren’t Lyme patients who require psychiatric
consults for various aspects? That is true, but for
a physician to have that as the only
alternative – and right now, that is the only alternative
under some of the guidelines out there, which is, “You
need to see a psychiatrist, because these symptoms… ” or “You have to go
home and live with it.” That’s what our patients
are told. Well, I happen to think there
are many, many drugs out there. There are many antibiotics. There is much science to
support a clinical judgment on a physician’s part to
try to get the answers and quite frankly,
after 44 years, folks, of having this around, the fact that we don’t have those answers
says that our system is broken. We have enough science. We just sent a rocket
off to Mars someplace and we’re sending them out to
the ends of our solar system and yet, we cannot, you
know, help these patients, and I think this is huge,
and I think it’s the core of the whole problem
quite frankly. And to reframe this,
I think part of the problem is not
just over-treatment, but under-treatment
and that gets down to “What is the etiology of
these persistent symptoms?” So I think there’s
a risk-benefit, and I think it is a physician’s
choice where you discuss with the patients, you show
them the scientific literature, you discuss your
clinical experience, but I think there’s just as much
of harm-benefit of over-treating when they may not have
it, as under-treating
when they do have Lyme and associated co-infections
and other problems. So it’s basically the big
picture that we’re dealing with, which is there’s the art of
medicine, there’s the science of medicine, there’s
personalized medicine for each patient, but I’ve
personally have seen a lot of harm of under-treatment and personally I
don’t use a lot of IV. I’ll hardly ever
use it these days. We’ve developed other protocols where we can use oral
treatments that are much safer. So I think it goes
on both sides. It’s both over-treatment
and under-treatment I think where the controversy’s lying. [ Pause ] Let me think. I’m trying to figure out how
to frame this as a controversy, but I think that controversy is
that people think we know more than we do, or the
lack of recognition of the uncertainty in the field. So I think the controversy is
people overestimate what we know on both sides of the
controversy frankly. So that the controversy is being
too dogmatic when a large part of the problem here
today is uncertainty about what we don’t know and
so I think that comes up a lot. It’s really how to treat
the patient in the… given the dearth of evidence. You know the evidence base
is poor in Lyme disease and so given that, how
do you treat the patient? I had a situation
where the evidence for what to do is lacking. In some areas.
I’m not saying in all areas. That’s an area… Well, depending on what you’re
talking about is an area of disagreement and that
I actually think the evidence-based is for treatment of acute early Lyme disease
is incredibly robust compared to other infectious diseases
that I have to deal with, and we don’t need to get
back into that right now, but I don’t disagree
that there are areas where we could improve our
knowledge base, and in general with these diseases
the answers… the best answers
are going to come
from knowing what we’re treating, and so it all gets back to, “Are we making a
precise diagnosis based on the clinical presentation, the appropriate laboratory
tests?” And then once we know what we’re
treating we may do very well. There’s some diseases right
now that are tick-borne that are really relatively
easy to treat like Anaplasmosis which can make you very
ill, but a short course of doxycycline essentially
eradicates it, and the nice thing about
that disease is we’re looking at PCR-DNA in the blood or the
organism both for diagnosis. We don’t need to do it for
treatment, because people… I mean, after treatment, because
people respond so quickly. It’s almost a diagnostic test
that you give the doxycycline. So not to get too precise,
but it gets back to the idea that precision about diagnosis
leads to the best treatment. I have a productive way
to frame the discussion that… without having a position
on one side or the other, but could we say, “Disagreement
on what treatments fall inside or outside of the bounds
of safe and effective for patients with – ?” And then fill in the entity
that you were talking about. As an area of controversy? Uh huh. Again, that’s “disagree on
what treatments fall inside or outside the bounds of safe
and effective for patients with – “. I don’t know if it’s
a chronic Lyme disease we’re talking about or is it acute
Lyme or is it all Lyme disease? But that’s sort of
a higher level way to describe what I think
we’re talking about. No, I think that’s a good
way to actually describe it, but I would put all Lyme
disease because even with acute Lyme disease,
when Gary Wormser published over 25 years ago in
Antimicrobial Agents in Chemotherapy that
the patients who had tingling
numbness/burning, they had peripheral
nervous system or they had central nervous
system, those are the ones who went on to chronic disease. So I think the gaps that we have
in the physicians out there is if you present with
multiple EM rashes where it’s disseminated,
where it’s disseminated to the peripheral or central
nervous system 30 days of doxycycline is not
necessarily going to cure that and I think that’s a gap of, “What do we do for
those patients? What is the best treatment
so that they don’t go on to, in my world, chronic
persistent illness?” But I think that’s a gap. I think early acute Lyme when you don’t have
that presentation. I think it’s much easier. And there’s still a range
for early acute, right? With the IDSA guidelines
for days, for duration of… Yeah, but it’s relatively short. I mean the… Not to get into too much detail, but there are two good
studies showing that 10 days of doxycycline was as
effective as up to three weeks and there’s a good
study for disseminated – this is I think Gary
Wormser’s study from 2003 – disseminated EM patients treated
with either doxycycline for 10 or 14 days – I forget which –
ceftriaxone plus doxycycline or a longer 21 day course all
did well and when you look at that paper in which I did – prompted by Wendy’s comment
the other day – very carefully, it is an incredibly thorough
look with neurologic exams over a year, with physical
exams start to finish, with patient symptom scales
all incorporated into that. So what I’m getting back to is we really have some
excellent hard work that’s been done really carefully
and really meticulously and we shouldn’t throw
that out when we have… when we’re talking about the
treatment of Lyme disease. We really have a good
solid basis in some areas that I think we ought
to be able to agree on. Beyond that there
are certainly areas where we could improve
our knowledge bases, but, um, and I… and throwing in the other
tick-borne diseases, I think we have a lot more we
can do in some of those areas where we just learned
about diseases that we haven’t even described
the full dimensions of. I think there’s some, um… So the studies that
you’re talking about, I think in some cases counted
improvement of symptoms. So without going through all
the studies, which I don’t know, I’m sure as well as you do, I
just want to be careful of that. Again, they weren’t
patient centered outcomes. They weren’t resolving
all of the signs and symptoms of disease. So I understand and I want to… just to echo Richard’s point,
because we did discuss this with neurologists and
neuro-psychiatrists that there is some discussion as to how much treatment is
important or is appropriate for early disseminated which
can be neurologic, right, just by the fact that
it has disseminated. So I just want to raise that.
It clearly is a controversy and something we
should put on the list. All right. So we’re going to ask for last
controversies and then move on. So I’ll open it up for one last
controversy before we finish this section. Wendy, did I capture yours? Is yours up here? I would just like
to reserve the right to later on add to the list. Yes, we can definitely
add to the list. This is not in perpetuity. One other controversy that
I see is the lethality of Lyme disease. We talked about Lyme carditis,
but one thing in the community that doesn’t really cross over
to literature yet is suicides and the mental health impacts
that often can lead to suicide and that often isn’t
attributed to Lyme disease as a direct cause of
death, but related. So I would say there’s
controversy around how serious
the disease is and the lethality
of Lyme disease. And I found it interesting that on the NIH website
actually it does give a number for Lyme disease. I’m guessing its cause of death. I didn’t go look specifically
as to what the burden is to get it recorded
as a cause of death, but it was 64 patients
I think in 2015 or 2016. The top level sub-bullet,
the “disagree on treatments,” it should have “safety
and efficacy.” Here? Just after… At the open bullet. It starts with “disagree”
and after “safety” you should
add “efficacy.” And then on the lower
bullet, we have Lyme disease, you know, “example: suicide.” I would expand that to
mental health and suicide. This past weekend at Lyme
Society’s Conference, Bob Bransfield spoke
and as an expert in that field he has
a lot of information that contributes to it. Like Kristen said, it’s not
necessarily what brought it on, but it was a contributing
factor. So definitely more
in that aspect. And I would add carditis. Yes. Also Lyme carditis. And again I would add, “How serious is the
morbidity/mortality of Lyme disease and
associated co-infections?” Because these are really
large gaps at this point and as I was bringing
up earlier, I think it may be
affecting other diseases that are not called
Lyme disease, like mental health
issues and the rest, but are necessarily
coming back to it. So instead of Lyme, could we
just make it tick-borne disease? Tick-borne disease would
be great, yeah. Diseases. Plural. [ Pause ] All right. We’re going to close
out this section. I’ll have us move
back to the slides. [ Pause ] In the next section
we’re going to lead into our first subcommittee
report. So, just a reminder that the
subcommittee reports were developed by subcommittee
co-chairs and their groups. They’re not the working
group reports. So the subcommittee
reports are the database… one of the databases that
the working group will use for its report. There are others and just because a working group mentions
something doesn’t mean it will be included in the
report and vice versa, there may be some things
that we decide to include in the report based on other
data sources that weren’t in the working group reports; but the working groups
did an incredible job. So they really do stand as
our starting point today for designing our
working group report. They were composed of, I
think everyone would agree, an incredibly smart group of
people that were passionate and so they delivered
us a project that will be presented now by the co-chairs of
the subcommittees. [ Pause ] I need to advance
my slides here. There we go. So some of the things that
are going to come up obviously as we do these subcommittee
reports is we’re going to start to see some common areas
of overlap and so we’ll try to flag those as
we’re going through. So you know education
is obviously going to appear everywhere
which is a good thing. We’ll identify differences
or controversies which we’ve started and
then as we discuss each of these subcommittee reports
we’ve asked the subcommittee co-chairs to prioritize for us. So we had over 150
recommendations. So we’ve asked the
subcommittee co-chairs to prioritize among their… Whether it’s two… We have a range from two
to probably 50 priorities for each subcommittee. The ones with 50 we’ve
asked to, you know, narrow them down for
us ahead of time. Those with two, you
can keep your two; um, and as a first point
for narrowing down and focusing our project. The types of recommendations – we can call them
recommendations now – at the working group level
include resources for research and programs, educational and
prevention recommendations, but other types of
recommendations. Basically, I would tell you at this point nothing is off
the table for a recommendation. As Pat pointed out, they may
not be good recommendations or achievable recommendations, but at this point nothing is off
the table for a recommendation and who will receive
our recommendations. We’ve heard HHS and the
executive branch, Congress and the legislative branch, but could our recommendations
impact other entities? Sure they could. So again, at this point we
shouldn’t narrow ourselves down too much. Alright. So we’re going to
start out with the discussion from the disease vector, surveillance, and
prevention group. The process for this is: we
have all the slides loaded from the groups and so in this
group we have all their action slides loaded. They’re going to go through one
slide at a time and help us pull out what they suggest as one
of the actions we should focus on initially and then we’ll
record those on a Word document, and then when we’re finished with that slide we’ll
go to the next slide. You’ll pull out your actions
to prioritize for the group. They’ll get recorded. When you’re done with all
your slides we’ll have a list of hopefully less than 50
action items at that point, and down to maybe 5 to
10, and then we’ll open it up to the group to discuss them and to get some discussion
going. But with a very high level now
of deliverable, because we need to deliver the recommendations
that are going to form the body of the report. So with that, we picked
randomly the disease vector, surveillance, and
prevention group and there’s your first slide
with your potential actions that were in slide one. And then just make sure
you’re being very focused and also letting
our recorder know which action item
you’re working on to… that you’re putting forward. Is somebody controlling
my slides? Oh. I think we both
are doing it. Okay. So I will keep
my hands off. I think our first
slide should be 19. That’s our first
potential action. Uh huh. Alright. You tell me if you
see the slide then. [ Murmuring ] These slides don’t match up
with the slides that we had. Our slides have numbers
on potential actions. We had numbering. We don’t have bullets. What did she say? She’s asking if these match
up to their slide deck. Yes, so they were taken
out of your slide deck. Okay. What we’re looking… “Potential actions: key issue
one” should be the slide we put up or you put up. Correct. Okay. Well, that’s going
to be problematic. Okay. First, I just want
to correct something. John, I never used the term, “there were not good
just for the record. I think the recommendations
in general were very good, just that some of them might
not, again, be something within the purview of
the federal government. Okay, I just want to clarify
that number one, and also, that we hope our subcommittee
doesn’t shoot the messengers. They did a fabulous job
developing this and just so you know, subcommittee,
we were directed by John and Kristen to narrow this down and we spent quite a
considerable amount of time last night doing that. So I’m going to have
to search here. The first item that
we’ve chosen: tick environment
habitat host research. Okay. Is that on that slide, because that’s the
first one that… Can anybody see it there? I don’t understand. [ Pause ] Pat, why don’t you just
then go ahead and read out the action item and we’ll
have our work order recorded that way instead. Okay. Yeah.
That’s fine. Okay and Ben is, I think,
searching it out here. That’s okay. Why don’t you just state
out the action item. They’re not the same. That’s what I said.
Those are not the slides. The one you’re reading from is
slide 19 from the one that… the deck that you did just
for when they recorded. It was slide 19. Yeah. So we apologize. But I can read it. So we’ll change direction.
We’ll just have you read
out for us on your… Yep. So it’s entitled, “tick environment
habitat host research,” and this would fund field
studies to identify key factors that contribute to tick
presence and abundance and how they can be
interrupted; for example, climate landscape change or
control of host populations. Particular emphasis
should be placed on funding vector
surveillance studies that can be compared
among sites and over time to improve our understanding of tick species distribution
and abundance. Fund research on enzootic cycles that sustain tick-borne
pathogens in the natural environment,
tick range expansions, and how they can be interrupted. Also, identify and
investigate Lyme disease vectors and hosts outside of
the major Midwest and Northeast Lyme disease foci
to inform the medical community about the true distribution
of Lyme disease pathogen and other tick-borne pathogens,
especially in California and the southeastern
United States. So that’s one of the
items that we selected that we felt was significant. We felt there’s agreement on
it and we felt it’s something that is really achievable. I don’t know what you want
us at this stage to say, or do you just want
us to move along? Yeah, let’s get the
list up there. Okay. Go ahead. Okay. So the next
one will come… Well, we have it as number
three under “potential actions” on our slide deck
and anyway, the… We have tick basic
research: fund research when pathogen binding
receptors and regulatory factors that enable tick-borne pathogens
to infect the tick tissues, proliferate, and
survive for transmission to humans and animals. So we felt that that was a very
significant area of research and also I want to add that
our group basically said in every area they
wanted increased funding, but we did not feel that
putting increased funding down the line would
be productive, so. But it’s an overarching
thing, obviously. Okay. So our next is under
our key issue two and it’s, “field trials and human studies
evaluating effective natural tick control products and
natural skin repellents for tick control, tick bite,
and human disease prevention. For example, use of skin
lotions, soaps, and repellents, or tick control products
containing nootkatone or other botanically-based
ingredients.” And we thought that
was very significant because there is a great
public outcry looking for natural products
of prevention. That’s not to say that other
areas shouldn’t be looked at, but I think that the public is
looking for something natural. Also, the next one,
“continued study and development of promising novel tick and
pathogen control measures, including molecular technologies for impacting pathogen
prevalence in ticks and animal reservoir hosts; for
example, rodent vaccination, transgenic ticks, RNAI,
semiochemical control and so forth and promotion of
private and public partnerships to engage industry and other
professionals to develop novel and effective products that
can be marketed to the public for tick-borne disease
prevention.” So that’s from the slide
that I have, anyway. Pat, could you let us know
what the one was previous to the one you just gave? Yes. The one previous; do
you now have the version? It’s… Actually, I
think its 21, number two, and number four from 21. Okay. If you hold on just
a minute, we’ll put it up. Okay. Oh, because
that’s key issue 2. What’d she say?
You said number 4, right? 2 and 4 from… 2 and 4. It’s one – 2
starts “field trials” and 4 is “continued study.” [ Murmuring ] Okay. Field trials,
continued study. Okay. It still doesn’t
have the numbers, though. Okay. All right. The next one is actually
what we have as slide 23 and the potential
action is the following, “have public health authorities
formally recognize alternative, validated, systematic approaches to tick-borne disease
surveillance such as systematic sampling
of tick-borne disease reports for investigation
that reduce the burden on tick-borne disease reporters,
but allow for comparability of surveillance findings
across states and over time,” and we did touch upon
that this morning. The next one is, “public health
authorities shall annually and when opportune, such as
during tick-borne disease awareness month, inform
doctors, insurers, state and local health
departments, the press and the public through official
communication channels including the MMWR, CDC, and
other official websites that the Lyme disease
surveillance criteria are not to be used for diagnostic
purposes.” And I just wanted to say, because I think it’s really
important to note this here that the whole committee
put this in in recognition of a minority report we
had about the problems with the diagnostic
and surveillance issue. So this recommendation
was accepted by everyone. Not as a minority report? I’m sorry. Not as a minority
report, you’re saying? No. Correct.
Not as a minority report.
It was accepted as the full. Yes. All right, the
next one comes… I have number 25 and it’s, “potential actions
key issue four.” Okay. Okay, now I want to
explain this a little bit because what this
committee decided to do, they actually originally had
five points which are listed on the slide, but because they
felt they could not prioritize those points they
took another tact. They decided to pull from
those points and to coalesce it into one theme, and that theme
is their actual recommendation, but I put this where it
came from so you could kind of understand the
synthesis of their thinking. So actually the priority or
the potential action here is, “to encourage commitment to
establish a nation-wide tick and tick-borne disease
surveillance network that is a partnership among
public interest groups, academic institutions,
and local, state, and federal government agencies to provide coordinated
standardized protocols for tick-borne disease
surveillance, tick collection, identification, and analysis to
identify established, emerging, and enzootic transmission
cycles with zoonotic potential. Proposed network includes the
coordination of local mosquito and tick control programs,”
and some of that, by the way, the part about the tick and
mosquito, some of that is based on certain things that
have started to happen. For example, in the
state of New Jersey, since the 90s our
mosquito and tick control by legislative effort – which
I did testify there to that – that they merged
those, and so anyway, that’s one of the things. But I just thought that I
would mention that in passing. And the next item comes on… Okay. Uh, slide 28: potential
actions key issue five. And now this action
has one change. Ben and I spent a lot of
time discussing this change and it probably sounds
like, “What? For one word,” but we had the
discussion in the subcommittee. It did precipitate a
minority report, but Ben and I have discussed it and we
feel that this needs to happen. So I’m going to read
this potential action and then I’ll tell you
what the change was. “Invest in programs that already
effectively link the best of tick science to people’s
lived experiences with ticks. That is cooperative extension; academic-based tick prevention
resources; advocacy groups; and update existing regionally
and occupationally relevant, targeted public health
intervention programs, including federal agency
safety manuals and handbooks to reduce physical and
behavioral tick exposure risks by addressing specific gaps
and knowledge and prevention.” So the one word that
we have decided to remove is the word “already.” And I’ll explain the
rationale for that and that… What that does is
putting the word “already” in there would limit
then, for example, if the government wanted to give
monies and they were thinking about it based, let’s say,
on this potential action that that would exclude
any kinds of new programs and innovative programs that
might be developed and so, there’s a concern that some
of the existing programs in this area don’t address the
needs of people in the South, in the Midwest, or
in the far West because their ticks might
have different behaviors, different diseases, and so on, and the people are not
necessarily being prepared by the existing programs. That doesn’t mean that the
existing programs could not change and come up to speed
and ask monies to do that, but we did not want to
preclude anybody who had ideas that might be more
relevant perhaps to those particular reasons. So that word is to be stricken
from that potential action. Pat, did that generate a
minority report then or not? Well, it actually… We had a minority report on
that and I think it was three or four committee
members that voted. It did generate a
minority report. Yeah. It did. It was three and seven and
then there were several people that were absent, but again,
the issue is after we talked about it and you said
prioritize and so on, we felt that that really
limited this particular action and we didn’t feel it
should be limited that way. So that’s why we did that – made
that judgment call and that… May I just say something? Oh, yeah. Go ahead. Yeah. I think just to what
the controversy settled on was, some people that… Well, the group that drafted
this, there was some idea that if you said “already”
it was sort of acknowledging that there were several good
tools that were already there. Why spend limited funds
to invest in another… in additional tools? And so this sparked
a big debate. It was one, “Well, what’s
the most responsible use of limited funding?” And that’s what “already”
was pivoted on and so I think after… And it did generate a
minority response and I think after we discussed it
further we thought, “Well, we want the best tools and maybe
it’s one that’s already there or why say it’s just that? Why not just say it’s whatever
the best tools are, period?” And so it’s really kind
of a simplification. Yeah. We wanted to provide all
the options to those who put in. I mean, maybe nobody new
will come to the plate, but we want to give
them that opportunity. We don’t want to stifle
innovative things coming about. And that is actually our
last recommendation – if you want to call it
that – out of our list. So can we put them up. Yep. So they’re already there. There we go. So each one that
Pat read has now… is now on this Word file. Uh huh. Okay. Okay. Is it possible that…
I don’t know if you can do it. Can these lights be
dimmed a little bit, because it’s really… You know I can see it, but
I’ve got to really like… Oh. Well, that’s a
good alternative. Did you want to go one by one? Yeah, I think we
could go one by one. Okay. So we’ll go one by one. Now there’s a… Is there nine points, I think? I think so. Yep. And we’ll take
them one by one now and it’s now the working group’s
time to work, to ask questions, make comments, see if there’s
ways to bundle these into things that reduce duplication and to
try to reach some decisions. [ Murmuring ] Did you… Excuse me. Did you want us to
say that we did… Ben and I had discussed – because we thought
you wanted this – two that we felt particularly,
you know, were significant. Two? Why don’t we start
with those two then. Why don’t you… If you have two high-level
priorities, why don’t we start with those. If you can identify them we’ll
start with those two then. It’s the first one. The first one there
is one of them. Okay. And the second one. Could you put your
mic on please? The first one is the
first bullet there and the second one is
down on surveillance. So it’s going to be about
your fourth bullet down. I have public health
authorities. Isn’t that it? Yes. Yeah, so it’s the first… Right, it’s that bullet. The first bullet on
there is slide 23. Yeah. Those were the
two that we selected as the highest priorities. So let’s go up to your
two high priorities. We’ll start with the first one. [ Pause ] There we go. So let’s open this
one up to discussion: tick environment
habitat host research. [ Pause ] Just a question for
clarification on this, would part of this be
coming up with standards and recommendations for the
states to do the field studies, then the federal government
would fund it at the state level or what was kind of
the thinking here? Because I know one of the
comments we had is that it’s so different across states. Ben, you want to address that? [ Pause ] Well, this is very multifaceted and I think there’s already
a lot of work that’s underway in terms of defining best
surveillance practices for tick surveillance is what
we’re talking about here. So I think for that there’s a
lot of ways that could be done. I don’t think it’s
that complicated, because people have been
doing tick surveillance for quite a few years
and there’s a list of pretty standard tools
that are used for that. So then the role of
federal government would be to identify the best practices and make recommendations
around that? Um, yeah. It could be. Ben, does this include the
ticks as well as the organisms in their microbiome? It’s both? [ Coughing ] Yes. Uh huh. Well, for “research on enzootic
cycles existing tick-borne pathogens in the
natural environment, tick range expansion;”
I think it’s looking at all of these together. The last sentence would
say, “Lyme disease pathogen under tick-borne pathogens.” So it’s a multi-disciplinary
approach. It’s looking both at the vector and the pathogens
that it transmits. Couldn’t you simplify that by
simply saying, “Increase funding for epidemiological studies
of tick-borne disease?” I think epi and ecological,
if you put both of those in together, um… Again, I mean we… This was an exercise
of a lot of people and everyone wanted their… all their keywords and phrases
in there which is a great place to start and then you
kind of boil it down. But I would say, “the
ecology and the epidemiology of tick-borne zoonotic diseases
in their natural cycles.” Something like that. I think it’s really
important in both these, because I was looking at a
lot of your recommendations and they did make that link
to what helps humans the most, because I can tell you
that we know a lot of – Bob Lane might dispute
this – from my perspective, I think we do know
something about the ticks, but it’s not getting translated
to doctors and knowledge about the disease especially
in the West where the strains and species are different. So how do we… How best can we take your
recommendations and connect that to patients
getting diagnosed and treated
more appropriate? And doctors really
understanding the risk and the different presentations
and the different regional risks of the ticks and tick-borne
disease that we have. So I guess that’s
an open question. I think they do address it,
but I would just maybe try and emphasize that in these two. I think what the working group
might consider is drafting a bullet that relates
a little bit more to health care provider
education about the regional
specific risks for tick-borne diseases based
on this type of information and I’m not aware that the
group actually went there as one of the considered actions,
but I agree with you that that’s an important
emphasis to make. I think from our perspective
that would be really helpful as somebody who lives in a
place where there are a lot of infected ticks,
but it’s not… Sometimes something is
lost in translation. So would you want to make
that as a motion to add that, you’re saying potentially? Because it’s not currently
in the report, Ben. [ Murmuring ] So you could ask us to add that… that if he wants. This is going to be
one of the big buckets, John and I’m just wondering,
as we go through all six if there’s a way to also
highlight it in red or green. Like you’re going to pull
these out when all six are done and that’s going to go
in the education bucket, because we’re going to end up
having to lump all of these and education is going to be
one of the ones that comes up. It came up in our subcommittee
over and over again. So I’m just wondering if there’s
a way to re-highlight the ones that are going to
keep showing up and identify the big buckets
early on for the writing groups. So I would put a bullet
here and put education or… Maybe in parentheses, you
know, put education or ED and then we keep that abbreviation constant
throughout and unique. Is that what you mean? Right it would be this for the
component that Wendy brought out about education, right? Yeah. I might… Other than education,
you might just say, “informed clinician awareness of
regional differences and risks,” something like that that’s sort of broader, but the
same concept. Yeah, specific. I would say more specific risks. Now that’s not to say that
Californians don’t travel to Europe or to the East
Coast and get bitten there – which is true – or people
from Nevada for that matter. So it’s a broader comment,
but here I think it is helpful for California providers to get
education on the specific risk to California, because
it’s still… That education component
is still an issue. So I have just a question
to follow up on that, because I agree completely that there are major
regional differences and we really need
information that speaks to those differences; for
example, Maine is very different than Dutchess County, New York
and so how fine we can get that I don’t know, but
the finer the better. But in saying that, is
there a particular reason… Are we leaving someone
out by saying California and southeastern US as
opposed to the West Coast; because certainly there’s more
known in Northern California about ticks perhaps
then other areas of the Northwest, for example. I don’t know. I just… I think it can be
general, but you’re right that this is on the
whole West Coast and it’s in Utah and other places. So I don’t… We don’t need to get
to a micro level, but calling out the
West Coast is important. Calling out the southeast
is important. So those specific areas
that aren’t served by the data currently,
just because there’s not as much done in those areas. And the other question
there is, was the intent to primarily restrict
that to Lyme disease foci or other tick-borne diseases? Because in terms of trying to
understand what’s actually going on in different places, it might
be good to leave that as open as possible so that we
really want to know, “What are the pathogens
and the cascades?” I comple… I agree. You know that
are the biggest problem and what is the eco-epidemiology
in that area as opposed to another area? In California you have
many different bio zones so that you’re going
to have lots of potential differences
there and I’d say in the Midwest there’s issues around these newly recognized
flaviviruses, Heartland virus and Bourbon virus, which certainly are deserving
of attention as well. I would like to add something. Since we’ve been… Ben and I were forced to
make choices, if you will. Last night at midnight. Last night at midnight,
that’s true. Okay. Anyway, the bottom line
is we had a bullet point, a potential action
which we didn’t include and it does have a sentence
addressing this and I wonder if that would be something… I think it’s a very
good sentence. It’s actually a portion
of a sentence. It’s slide 27, if you go
back to the presentation, if you want to just show it. Yeah, it’s very short. It’s not too long. “Encourage a pipeline
of innovation to science-based
prevention education by providing additional funding for practitioners
both individuals and entities proposing to conduct objective
assessments…” Oh wait a minute. Is that it?
Or tools? Yeah. No. Where’s the other one? I think it’s that one.
Wait a minute. Sorry about that. Isn’t it number one right
there on that slide, “focus future tick
prevention education.” Yeah. But where’s the part
about the documented increase? Yeah. We took out that
first part, though. Okay. So I will read
the whole entire thing and then you can pick
out, if you would like it. “Focus future tick prevention
education on those practices and activities with
positively measured outcomes such as reductions in
the number of ticks found on study participants
or outcomes related to the tick encounters “bites
disease,” a documented increase in knowledge or the adoption of
specific prevention behaviors and then encourage a
pipeline of innovation to science-based
prevention education by providing additional funding for practitioners
both individuals and entities proposing to
conduct objective assessments of their intervention or tool.” Um, so that was something
that we did not, you know, include in there and I don’t
know if there’s anything there that you feel that you would
want to take out of that. But we wanted to
make sure you knew that there was something there. I don’t think it gets to the… I don’t think it’s… The regional? …so wide of a point. Yeah. Right. Uh huh. Yeah. Our minority report
actually addresses, you know, that a bit about the
regional issue I think, but yeah, whatever. I know… I don’t think
we disagree at all with putting something
like that word. So I think Wendy yours is
simpler and to the point. You know maybe we
should consider that language for an addition. Alright. That’s fine by me. Alright. Well, let’s… Any more discussion on that? I’d actually like to make that as then a motion
so we can add it. Do we have the language? Um, it’s that second
bullet point, “education.” The second bullet. Okay. Yep. Okay. I make a motion to include
that in the report as a prior… as a recommended action. Yep. I second. Good. Any discussion on that? It looks like agreement. So I’ll ask, all in
favor say, “Aye.” Aye. Opposed. Abstentions. Excellent. So we’ve added to… We’ve added something
you’ve narrowed down, but you know the group
has added something back. The process is working here. We’ll take it. Exactly. alright. So that was an addition to
this first highest priority. Are there other discussion
on this highest priority as a full item before
we move on… before I actually… we vote on it, I guess? No. Anymore discussion? alright. So then
for this first one of your two highest
priorities, go ahead. Okay. I guess I’m asking
a process question. Uh huh. Okay. I don’t object to voting on this
because I don’t think it’s going to impact anywhere else,
but if we go through and before everybody is done and
vote on everything there’s going to be significant overlaps. I mean, we’ve seen places
where goals overlap, so should we be voting
on them now or? You know, are you
following my… Because let’s say for example
we go to Richard’s report, okay, just for an example and
now we’ve voted this one in from our report. Well, let say Richard’s
report has something that has, you know, the same focus, it may
be a little different wording. Now what are we going
to do about that? Are we going to throw it out? Are we going to have to come
back and include whatever it is in Richards that’s different? You see where I’m
going with that? Yeah. So the writing
groups that we’re going to form for instance… We’ll just use this
specific example. There’s almost certainly going to be a writing group
on education. So if you’re education
there goes in that bucket and Richard’s goes
in that bucket, the writing group can combine
them at the phase of writing. Okay. That’s fine. Thank you. Yeah. And in terms of process, you know the working
group here we can decide to do something different rather
than going through each one and voting, as we just did this. One approach that Richard
had earlier was maybe we come up with those big picture
buckets like education, diagnostics and testing, maybe
treatment and patient outcomes. So if we want to pivot
and have a discussion on what those big
buckets might be that could help our
discussion as well. So it’s open for the floor. I think it makes a lot of
sense, because as we go through all these slides and all
the recommendations we’re going to find there is
a lot of overlap. We found it in our report
with Allen and myself. So I think if we can identify
it early on then Jennifer and the rest, you can start
knowing that it’s going to go into those buckets
for the writing groups by the time we’re done. Okay. You wanted us
to go through the… Oh, I’m sorry. Are you finished
on, with your… So, the group’s kind of
discussing whether you… You’re proposing we pause and
address those buckets now? Yeah. If we could come to what
those big theme buckets might be and we don’t have to
have it perfect now, but if we have a starting point
we can always edit them after. I think that might help us move through the different
subcommittee reports and I heard education
as one of them. Right. So we’ll need a new… Good, start a new list for us. Okay. So I’ll just throw these
out as a place to start, okay. So the leadership team
talked about these. We’re not saying this
is what they should be, but here’s a scheme for
how to create buckets. One would be education,
number one. Number two would
be surveillance, whether it be what you guys
are talking about now, tick, pathogen, disease, human
disease, surveillance. That would be a second bucket. A third one we proposed
combining diagnostic testing and pathogenesis
treatment together. So diagnostic testing and
pathogenesis and treatment because they’re so
closely linked, the testing kind of deter… you know, runs…measurement
runs off of pathogenesis and without measurement and
pathogenesis it’s hard to talk about treatment; so we
kind of put those together. We put together the
access to care kind of is its own possibly
with prevention. So access to care, prevention. And Richard and I had a
discussion about disbanding his as a standalone and Allen’s which is other tick-borne
diseases and co-infections because they clearly
crosscut everything. So we would distribute the
other tick-borne diseases and co-infections into
all of these groups. So we would eliminate that as
a group and then the last one, the question is whether to
take vaccine and therapy. Therapy clearly overlapped with
Wendy’s group and treatment; so at least that part of it
overlaps with the pathogenesis and treatment group and
then whether to put vaccines with prevention and then that
gives us kind of four working… four buckets. There’s a plan here, because
these would be the writing groups basically. You know so that gets us
down to four writing groups that then can, you know,
collect these things from the different
subcommittees, like education, that appear everywhere. So that’s a proposal that we
put out there for discussion. I think that sounds like
a good series of buckets. I had one question. I’m sorry. I had one question
on the surveillance. I wouldn’t want the tick
ecology/biology to be lost under the term surveillance. So I would just make sure
that that’s captured in… Because when you talk about
tick surveillance that’s sort of one level, let’s say, and
you can take that a lot further. So and I have, you know, I
think prevention as a category that includes field prevention
and personal protection and also vaccines
seems to make sense. I don’t know what
Dennis thinks about that. Agree. Dennis agrees. So that’s… Let’s keep discussing that. Those are kind of the buckets
we thought of and again, these would be the
writing groups then. And the advantage of this is
it kind of mixes up people too. Now you’re no longer just
talking to the same two people. We’ve mixed up the different
topics and as we’re addressing as a whole working group. So just to make sure we capture
that comment in the notes, we want to add eco-epidemiology
to surveillance? Yeah, actually I see a problem that I hadn’t anticipated
there with the… Prevention, I was
thinking in terms of interventions you can
do in the field as well which could be separate
from the eco-epidemiology. The eco-epidemiology would lead to studying different
interventions in the field that might lower the
risk for tick exposure. I actually would separate
prevention from access to care. I think it gets lost
a bit in that. I think it deserves its own box. Yeah, I plus-one that. My thought was either put
prevention with education or have prevention be its own
thing, but I think prevention and education vaccines
could all be one group. I would agree with
education on its own, because it’s not
just clinicians. It’s clinicians,
patients, patient’s family, laboratories, diagnosticians. So it’s a group. If I understand that right,
we would break prevention out to its own fifth bullet. [ Pause ] Is there a thought… a school of thought that
says, “Prevent field and personal” should
go into “surveillance” and “vaccine” should
go into kind of the “human testing pathogenesis
treatment vaccines?” As an ecologist, I think
you’ll lose a lot from… by bundling the eco-epidemiology
with all the prevention. There’s a ton of science that
we can pull from macro-ecology and help inform some of
this field, but it’s… I think it would get
lost if we bucket them. Do you want to include
under education, clinicians, patients and insurance? Yes, please. I think along the lines
of what Wendy was kind of suggesting is I think you
could rename surveillance as eco-… ecology/epidemiology. That would then include
surveillance and then the aspect of prevention which is
really field and personnel which is exposure to
the tick really falls under the epidemiology. Vaccines and the other
things can fall under more of the healthcare side. Okay, how are… Are we actually regrouping
this then? Well, how would you
like it regrouped? So the top level, instead of
“surveillance” you could have “ecology and epidemiology” and then “surveillance”
would be a subset of that. Okay. Gotcha. [ Pause ] I don’t know if I’m
okay with this period to be honest with you. I mean our subgroups have
spent months and months in putting their efforts and
putting these into categories that we tried to stay
within those categories and now what I’m seeing is… I don’t know. I see we’re breaking
it up in different ways and I’m wondering, is that
going to change the emphasis when we do the final
report somehow? Because the reports
were organized before in a certain way. Now they’re going to be
organized in a different way and is that going to
change the emphasis of the report that we present? I don’t know. You know I just don’t know. Couldn’t we… I mean couldn’t we keep the
same categories that we had and if there’s an
educational component of those categories, well fine. I mean that’s not an issue. Putting an educational
component in, but reconfiguring I just am… I don’t know. So one rationale
for trying to come up with different buckets
was that we have not yet, in terms of the process, had
the subcommittees really talk to each other and identify where the potential
synergies and overlap are. So we thought by forcing it and
changing it it would allow us to have that cross-pollination. The outcome of the
report may default to the subcommittee structure, because that makes the
most logical sense, but for this next version we’re
hoping to mix it up a bit rather than stay in our own silos. And there is a huge
overlap in education. I mean it’s also a
way for efficiency. You know we have…
The report can’t be 500 pages. So just by bundling education
that simplifies the length of the report tremendously. [ Pause ] Say something. No, I’m just trying… I’m sorry. I’m a little slow. I’m just trying to wrap
my arms around this. I felt like we spent,
you know, all these weeks and weeks writing these
subcommittee reports. We pulled all these people in and at our last working
group meeting we sort of decided buckets and I’m
still kind of struggling with what the exercise here
in creating new buckets which actually overlap the
old buckets and are using much of the same vernacular
and I just… Given the limited time and
energy that all of us have to put into this, are we
suggesting that we’re going to now restart the whole
process and rewrite all of this just pulling pieces
from what’s already been written or are we trying to develop
a framework to look at this and crosscut it and try to say, “How can we simplify,
shorten, and…” I mean, I’m the first to say
the bullets that we just showed, you know, I would’ve taken
each of those if it were my job and cut them down to a simple
easily understood umbrella statement, but you know
the people that we engaged in this all wanted all
the detail and we felt like it was easier to put
all the detail there first and then… rather than cut it down
and everyone saying, “You left out this and
you left out that.” And so I think all
that’s doable, but I guess I’m just
trying to figure out this. I mean we can… This is okay with me. I mean epidemiology,
ecology and epidemiology; yeah we can talk
about surveillance. We can talk about
vector surveillance. We can talk about tick
biology and control. Prevention, you know
really crosscuts. You’re talking… I mean I’m just thinking
out loud right now. CDC, when I hear prevention, I’m thinking primary,
secondary prevention. Primary prevention is
preventing tick bites. It’s all those things. Secondary prevention is
early diagnosis and treatment so that you don’t go on to… so you prevent more serious
outcomes and vaccines are part of prevention, but it
clearly crosscuts both ecology and also clinical aspects of… You know so it’s two
very different groups. So you know that’s what going… That’s why I’m having
a hard time responding. My thoughts are kind of all over
the place with this right now and I don’t disagree with it. We can do that, but
I would just caution, we do have very limited time and
I for one don’t have time to, you know, have committee
meetings or group meetings every week and rewriting something
we’ve already written. So that’s my only
word of caution. I’ll just say, I mean
I had the same thoughts when this was originally
presented in trying to keep things intact and do
that, but there were things like the duplication and
the idea had been that… If we create these new
buckets, and we don’t have to, that we would pull in pieces
from all the different reports. It wouldn’t be rewriting
from scratch that, you know, if we approved this
first priority, Pat, you know we’d pull that in,
you know, the language of that into that report,
into that bucket. So it wouldn’t be creating it
from scratch, but you’re right. You know we invested
a lot of time in creating the original
structure and maybe we do a highbred. Maybe, you know, Al’s and
Richard’s because they’re so… You know their big problem
was they encompassed so much that cross covered. Maybe there’s would get
pulled into the other people and we kept those intact. That’s one possibility. I mean it’s… You know we’re discussing it. Yeah, we were absolutely
thinking that you would cut-and-paste
different parts of the subcommittee reports, not reinvent the
wheel and start over. Um, the other filter for
how we came up with this when we were thinking about
it is, “Who is our audience? Who’s our reader?” And with people on the
Hill, will they care about pathogenesis transmission
or treatment or is it going to be education that
grabs their eye? What are they going
to be going to? And so these sort of broad
buckets we thought would be somewhat logical for high level
decision-makers on both the Hill and the Secretary’s
Office at HHS. Uh, Coop and Bob, what were
you all thinking about? And it might help us to hear
what your two priorities were going to be to jump
ahead just to… Because I know you had thought
through that a little bit. Uh, well, also if… Before I forget, if we are going
in this format with education, we’d have to add
caregivers in there also. But you know we pretty
much narrowed it down that if we all agree in every
group that subcommittee that a test is needed,
a better test. So if we take that off the
playing field it goes right into treatment and with
treatment it’s individual treatment, because
insurance problems and not one-size-fits-all
like a cookie-cutter. We’re all different. So you’re going by
clinician’s opinion which I know you earlier said
that would lead into prevention, but for us then it
came into support. So we really had,
you know, a top three and taking testing off,
you know, for the access to care just gave
us really treatment. It’s the individual treatment
by diagnosed by the clinician that each person is an
individual and needs to be treated differently. Yeah and I think we… You know we wanted to
emphasize and we did last week with the IDSA footnote to really
try to get that emphasized, particularly how it
talks about the clinician and the patient working
together, how patients are
individuals, as Bob said. So you know I think that was
a high priority for us to kind of get a return to that,
to recognize that footnote and that these are guidelines
with the caveat that it’s up to the clinician and
the patient together to determine the best course
of treatment and I think also with education, we had… That was one of our key themes
was awareness and education. So that throws the
general public in there, not just patients
and as Bob said, caregivers, certainly insurance. It goes to state legislation. You know with that
it encompasses a lot. So I do think education
should be its own, but I think we could
probably take, you know, what everybody’s got
with that, but… Does that… Yeah, but then would that
make treatment its own… Debbie was just asking me, would that make treatment
its own bucket then? Well, then I’ll ask Wendy. I mean you have… What do you think? I mean you’ve got an
overlap with the vaccine and therapeutics
group and the… on the therapeutics part of it and then you also
could combine… What do you think
about combining with the testing group? I’m okay with it. We’re not making… I mean what we’re
recommending is trials and more inclusive trials. So I think that does… I see it as, you know, what’s
happening in the patient and the patient-doctor
interaction. So I’m not… I haven’t so far found a
reason to be against it and I think it does make
sense to Kristen’s point about remembering your
audience and we do have to… I mean, fact finding is
different than fact delivering and so we need to take that into
consideration, because, I mean, there’s some deep detail
here that we are… that’s not going to translate. So we do have to think about
how to package it correctly and I think this does get
to that even though it takes out some of the detail that we
were all hanging our hats on and that we needed to really
come up with a recommendation. So, David, do you have
a thought on this? Well, I think you’re
exactly right. I mean if we go back to
what the task before… [ Stream Cuts Out ] Welcome back to the
afternoon session of the tick-borne
disease working group. Before we get back to our
main program I just want to make an announcement. The live stream from the morning
actually crashed for 15 minutes which means there was no
recording done during a 15 minute span of the working group
meeting and so, unfortunately, when you’re viewing the
live stream there is going to be a 15 minute gap where there’s nothing
being transmitted. Because of that, I just want to review what may have
been encompassed by that gap and the latest where
we ended up. We ended up actually
with a nice synthesis of what the writing groups
would be around the topics and these writing
groups, largely, but not completely are parallel
to the subcommittee groups. So for instance, the first one
is epidemiology and ecology which has a huge degree
of overlap with the… with that subcommittee
group on vectors. The second group is prevention which was not one of
the subcommittees. So that will be a
new writing group. The third was diagnosis
which was a subcommittee. The fourth will be treatment, which really combines
two subcommittees and the fifth will
be access to care which of course was
a subcommittee. So those are the… If you missed that
in this morning, those are the five
writing groups. You’ll see that other
tick-borne diseases and co-infections
is missing that’s because it really
spans almost all of these five writing
groups; so Allen and Richard will be
plugging their pieces into these five groups
and similarly the vaccine and therapeutics group will get
plugged into the therapeutics into the treatment and the
vaccination into the prevention. So those are the groups
that we ended up with. I have just a quick
question about that. Yes. So are you telling
me both the audio and the visual portion? Yes, that’s correct. And they… Is the audio and visual
separate entities now like it was in past meetings? No. So this meeting is live
stream from here from the hotel; so the audio and
video are together. So there’s no audio recording of anything we said here this
afternoon for those 15 minutes? No. Only for the 15 minutes. Now we have an in-room recording
that has recorded everything that you have said
since you came in. Oh, okay. So that still exists, but for the live stream it
does not for those 15 minutes. Got it. Thank you. Yep. alright. So we’re going to go ahead and
dive back into our program. The next group that’s going to present is the
pathogenesis transmission and treatment subcommittee
report with Wendy Adams and so we’re going to… and with David… David Lieby. …Lieby, as well. And so what we’re going to
do is what we did before. We’re going to pull out
the prioritized items from the subcommittee in
real time on the screen. So we’ll be pulling them
out for the group to look at and then we’ll discuss them. So the priorities were
number one, “What mechanisms of Borrelia burgdorferi
pathogenesis allow it to persist in some animal species despite
a competent immune system and/or antimicrobial therapy and what
are the gaps in human research that need to be addressed to explore this model
pathogenesis in humans?” Number two, “What
is the pathogenesis of persistent symptoms
in antibiotic naïve and anti-biotic treated
patients? Are there biomarkers to determine the continuing
presence of infection? And what are the gaps in research regarding ongoing
symptoms related to the effect of delayed diagnosis,
immune dysfunction, persistent infection,
co-infections, and neural dysregulation?” and number three, “What is… are the best treatment
regimens for acute Lyme disease and for patients with
ongoing symptoms who have or have not been
previously treated?” And the gap is, “What
are the tools needed to measure treatment outcomes
in Lyme disease, including but not limited to
patient centered outcomes, clinical practice outcomes,
and innovative research tools?” So if you go to the next page. So for priority one our
recommendation was to, “Promote research
on animal models of Borrelia burgdorferi
infection and the mechanisms of disease processes in humans
with an emphasis on pathologies that are currently lacking,
e.g. neuroborreliosis. There’s insufficient
understanding of mechanisms of disease in animal
models and we need to understand how applicable
these are to human disease.” And number two, “Pursue
further study of mechanisms of Borrelia burgdorferi survival
during infection processes and its tolerance to
antibiotics and other stresses. So, the immune system is
affected by Borrelia burgdorferi to enable establishment and
maintenance of infection in immunocompetent
hosts and animal models and human case study show
that the pathogen may persist after antibiotic treatment, but if that persistent
infection still is there it’s at the etiology of
continuing signs and symptoms.” Can we get that as
full-screen, please? [ Pause ] And so I think I’d like
to go to the next page and then the page after. So this… these were combined potential
actions for priority two and three, just to reiterate. So potential actions: “Conduct
clinical trials using more inclusive entry criteria
representing the heterogeneity of patients seen in
clinical practice and including different
treatment approaches. Insensitive testing
has led to a data set that may not be representative. Current data from trials
are not generalizable to clinical practice and we need to utilize innovative
patient centered trial designs and big data tools to accelerate
research and promote shared and medical decision-making
in clinical practice.” And number two, “Develop and disseminate more
comprehensive clinical education that highlights diverse
symptomology, expanding geography of
infecting ticks, and limitation of current testing procedures and these education tools
should include a diverse group of stakeholders including
clinicians, research scientists, and patients that represent
the spectrum of scientific and medical expertise and
perspectives on Lyme disease.” So I don’t think we need
to go to key themes. I think if we go to
priority one, I would… So David and I would
suggest if we… Number one, education has
already been dealt with. I think the gist of the
group is that education needs to be a theme here and that for our group it was a
theme relating to clinicians and clinical expertise about
the heterogeneity of disease, what are the different
presentations; medical education; as well as,
you know, and medical schools; as well as physician education in continuing medical education
series which are available; but just the heterogeneity
of disease and also the expanding
geography of ticks and the increasing number
of physicians from states that maybe aren’t considered
endemic and yet will still run into patients in their practice
who may have signs and symptoms of disease, be it
from Lyme disease or other infectious
diseases from ticks. So I think that has
been covered. I think the two that we would
like to propose are number one, to take the animal model and
mechanistic study and combine that into one priority. So it would be really promoting
research on animal models of Borrelia burgdorferi and
the mechanisms of disease and using those models to
study survival during infection processes and tolerance to
antibiotics and other stresses. And that kind of combines
the research that was done in the pathogenesis section,
but also influences treatment because we need to
study the animal models to really determine what’s
going on in humans or use that at least as a
roadmap to then guide and educate our study of humans. So I would promote that
as the first priority and for the second priority
would be – if you go back to two slides down –
to really conduct… take the first action here which is conducting clinical
trials using more inclusive entry criteria that
represent the heterogeneity of patients seen in
clinical practice and in including different
treatment approaches. So we really need a
better clinical data set on who these patients
are, how to treat them, and what are the best outcomes? Realizing that randomized
clinical trials are hard to do in this population,
but that we need to really study these patients
to find out what’s working and what’s not, and that might
include using 21st century tools, such as patient
registries and big data tools to use those as hypothesis
generation for randomized clinical
controlled trials. So I’d throw that out to the
group as our recommendations. David, did you want to add
anything to that, though? No, perfectly said. [ Pause ] Okay. Thanks. Alright. We’re open
for discussion. I had a question about… I can’t remember if it was
in your subcommittee report or a different one, but
someone mentioned leveraging ClinicalTrials.gov in that
infrastructure for Lyme disease and tick-borne illness. Is that under this bullet or
could it fit under this bullet? In what way? In that we need to
advertise trials or use it to generate patient input to… Um, I was thinking of it the
way they have for cancer is to really match the diversity
of trials that are out there with patients so that,
um, that basically if there are Lyme disease
studies they would go into one database,
one repository so patients could find out
trials that are out there. That’s certainly a
great suggestion. I always kind of
operate on the assumption that maybe it’s incorrect
that if you’re doing something for patients they will show up and that recruitment
wouldn’t be an issue so long as it incorporated
patient centered outcomes and that it was done with… in consultation with patients
that you would be able to find both providers
and patients who were interested
in taking part. So what it be okay to
add ClinicalTrials.gov as a fourth bullet point
under the sub-bullet points? I think that’s fine. I think that’s fine. A question on the term
“inclusive entry criteria,” can you expand on that? My underline that question
is, it’s very important to have a clear case definition
for most diseases that we study to say, “This is pretty sure that we’re studying
this disease and that.” So I kind of get where
you’re going there, but had you wrestled with
the issue of case definition? We do and Lyme disease is so
problematic for that reason, but the problem is we
are treating patients and extrapolating on a data set
that doesn’t represent patients in their entirety and
I understand, you know, the rash is a really
good example where it’s a nice positive
sign that you have Lyme disease if it has central clearing. The problem is many
people don’t get a rash. We don’t know why
they don’t get a rash and we don’t know
if there are… if it’s a seasonal, if it’s
tick specific, if it’s Borrelia, specie problem, or is it
an immune system difference in immune system reaction? So without really
understanding more about why some people
get the rash and some people don’t,
it’s hard to… It would be a shame
to exclude them. Your point is well
taken, though, is that you want really
tight inclusion criteria’s so that then you can
believe in that data set. The problem is we don’t know… We don’t know how to treat
patients or if we need to treat them the
same or differently if they don’t present
with a rash initially. Well, I’m just wondering if
some of that might be answered. If you had better
early diagnostic tests, let’s say in five years you had
better early diagnostic tests, and you could pick out people
who had early Lyme disease that had typical EM or
didn’t have a typical EM, at that point you could
have criteria for a study that would really
carry, I think, more half than if you don’t and
the other question, sort of part of that is, do you prioritize
what aspects of Lyme disease? You mentioned neuroborreliosis
might be a higher priority versus a lower priority in
terms of clinical trials given that clinical trials are
complicated and difficult to do; particularly good ones. I think neuroborreliosis
we really want to study on a pathogenesti
level and how it… what it looks like in animals so we could understand better what it looks like in humans. I think the focus was really
on, “How do we treat patients who have continuing
signs and symptoms after initial antibiotic
treatment?” So I would prioritize
those patients. I think that was the focus
of our paper that we wrote, but I think there’s certainly
may be independent applications or indications where you would
want to study that group better and we thought even about
Lyme carditis, you know, is that something we want to do a clinical study
on and recommend? And the answer was really,
“no,” because it looks to be like there’s a good
treatment there. The problem is identifying those
patients in a timely fashion and discerning which
are so you don’t have to insert a pacemaker. So I think there’s… It’s worth discussion
which indications, but I think for us the focus was on continuing signs
and symptoms. One thing that we’re
forced to do as clinicians all the time is
there was a validating screening questionnaire that made it into
the medical literature last year in 1600 people and one of the
hallmarks was migratory pain, migratory joint pain,
migratory muscle pain, and migratory nerve pain and in this particular
article there were only seven differential diagnoses
for migratory pain. So if someone had the classic
constellation of symptoms that was pointed out in
the Redman paper with John or the other papers that we’ve
done with fatigue and headaches and sleep disorders and
concentration problems, migratory pain, and they
were two standard deviations above the mean on
the questionnaire, you’ve done a differential
diagnosis of migratory pain, they have an ELISA that
could be a C6 ELISA. It could be an IFA and they
have Borrelia specific bands; it could be either an IGM blot. It could be a full
five band IGG. Could even be Borrelia
specific bands like 39, but that you’ve done
a differential to rule out other diseases. There may be other tick-borne
infections and co-infections, but as a clinician, that’s
what we’re forced to do is to do differential diagnosis
all the time and we’ve at least found in our
practice that it’s a useful way of differentiating especially, because this questionnaire
has been validated in 1600 people statistically and the Borrelia
specific bands helps because of other Borrelia
species that are out there. We may be seeing an overlap when
you look at the prior evidence on STARI in Ed Masters group. A lot of those bands that we
see in the Northeast show up… some of those bands are
showing up in the studies that Ed Masters did years ago. So I think in looking
at those criteria, a group could get together
and talk about this, but I think looking at
clinician standpoint, validated questionnaires,
migratory pain, Borrelia specific bands,
evidence of other tick-borne or co-infections,
ruling out other diseases that cause those things, I think
that’s how you can maybe get to a clinical definition to
kind of expand out the grouping of people that would go in. [ Pause ] A different question
is, do we now start to interject other tick-borne
diseases and co-infections into these bullets or not? I mean we discussed
animal models ourselves and it was an important
thing and do we take out Borrelia burgdorferi
and put tick-borne diseases or do we put Borrelia
burgdorferi, other tick-borne
diseases, and co-infections in each one of these things? I mean I think you can. We… Because we’ve agreed that
we’re heading in that direction. So I think it’s appropriate
now and as well as when you do your
presentation. So, I mean, Wendy, um… Well, I think… And we had this discussion,
especially as it pertains to inclusion criteria
for trials. The truth is we haven’t done
trials with co-infected patients that we know of, right. That that’s usually
an exclusion criteria. We need to know whether or
not those patients fare better or worse than just
standalone Lyme disease or standalone Babesia,
for example, right. So and studying those in animals
would be a good first step, but we don’t have those models. We certainly have some patients
that we could track over time, but it’s a really
interesting question, because from an inclusion
criteria you don’t want to over, um, you don’t want to
make it overly broad, and yet you have a patient
population that needs to be tested with these, you
know, two or more infections that are simultaneously
infected. So it’s a little bit of a
conundrum in chicken or the egg; which do you test first? So Wendy, I’m hearing… So you’re favoring a broader
definition as opposed… You know, in the world
there’s lumper’s and splitters. So I’m obviously a splitter. Um, you know and so if
you abandon the idea of splitting first to where
there is a better case definition for post-treatment
Lyme… Well, let’s… Why don’t we split into
a clinical diagnosis versus a legitimate
rash or a two-tier? Right. I think the ration
the two tiers have been… Well, that’s not true. They haven’t totally
been exhausted. We still don’t know
what works in patients that present that way. I think I would… You certainly could,
as a first stage, do a clinical diagnosis
trial and see if those patients get better on
a, you know, a certain regimen and that there are
certainly enough physicians that have a good enough
experience diagnosing those patients. Now the difference is they
don’t usually present or often times they don’t
present until later disease or at least that group of
physicians doesn’t see them until later disease;
although, I would say that most of the treating physicians
I talk to do have some part of their practice that
they reserve for people who have a tick bite and
have symptomology now; that they become known in
the community as somebody who can see you quickly
for that kind of disease. So I do think it’s a
population we need to study, because we don’t know who
gets a rash and who doesn’t and we shouldn’t be
extrapolating to the whole group of patients that
has Lyme disease when we don’t know why
there are some people who don’t present that way. I’m not sure whether
Allen’s question on… Were you asking whether the
treatment of pathogenesis and treatment of other
tick-borne diseases should be part of this bucket or are
you specifically asking about co-infections
as it lines up here?
So I just wasn’t clear on that. Well, I guess we just
discussed using animal models, especially with new causes
of tick-borne diseases where we don’t know much about
pathogenesis or treatment, etc. Um, so that’s
where that came up in individual other
tick-borne diseases. So we had just… Since we’re going to lose our
slot, when do we start sticking in those other two words, other tick-borne diseases
and co-infections? I was just… Obviously the point of my
question was to make sure that part wasn’t lost of being
a splitter of looking at, “What are the characteristics of particular diseases
in that context?” [ Pause ] Did you have recommendations
about how to conduct the… you know how to resource
the clinical trials? Well, yes. We need funding.
Is that what you’re getting at? I mean I think this whole… We’ve talked about
public/private partnerships. We’ve had a range of suggestions that have come up so far. I think… So the idea of hypothesis
generation and using public/private
partnerships potentially to generate hypotheses
for as who… you know, how you do
the clinical trials to advance quickly
those hypotheses so that you don’t have to,
you know, it’s not one drug versus 20 patients and then
one drug versus 20 patients. Um, so I would suggest that we
try and think creatively for how to find different treatment
modalities to test, but yes. I mean, these are
expensive trials. Lyme disease trials have
not been done recently. They were done a long time ago. We now have more information about the disease I would say and probably more information
in how it presents clinically and what may be relevant
endpoints should be. Uh, a patient member of our subcommittee had a
creative thought on this and it was particularly
getting at how the patient – excuse me again – feels and
functions getting at the signs and symptoms and thought that there was a missed
opportunity with Pharma to… or developing drugs for
these to consider a subset of patients maybe in a nested
study from the Lyme arena to see if there’s benefit there; because if there is it could
be a win-win for the patients and for the manufacturer
to expand market and so how one does that is
dependent upon both partners. One partner can only
do their part. And I think you… I thought that was
a creative thought and something that could… Yeah, I think… I think as somebody who
comes from industry, I always think of, you have
to sell them on the market, that there has to be
a really big market and right now I still think
there’s maybe an overabundance of belief that doxycycline cures
all cases with 2 to 3 weeks. So and part of this goes to getting better
numbers on diagnostics. It also goes to seeing what
works in post-treatment Lyme and maybe proving that
there’s a population there that can be served by a
pharmaceutical company as opposed to just a
one-size-fits-all antibiotic. So these would be
agnostic as to cause. So it’s whatever’s managing the
symptom here would be the thing that you would try and go after
by the suggestion that was made by our patient member? I haven’t thought
enough about it. So yes, there are symptoms
that could be managed and certainly there are
symptomatic treatments that are used in Lyme disease. I guess that’s… It’s up for further discussion
how you would best approach pharmaceutical companies to
enable and encourage development of drugs for this indication, but characterizing the
population is certainly an important first step of
that process, I think. I just wanted to mention,
again, that we could go back to antimicrobials, but there
may be other paths to relief of people who have persistent
symptoms after treatment with antimicrobials
and sort of guess to the same the pathogenesis
question. So if you find out
it’s cytokine X or Y or something is particularly
turned on and is your biomarker for somebody who has persistent
symptoms, the response to that may not necessarily
be more antibiotics. It may be that the trigger
is not a live bacterium at that point. We want to continue
to explore… first of all understanding
the mechanism of those symptoms
before you jump to a clinical trial which is… It has to be based on
a very solid idea of, “This is what’s causing
this,” at least in my mind and because you’re going to put
a lot of resources into that. So in my view it makes sense to
explore the pathogenesis first, as well as you can, and
then when you see something that lights up as a
potential opportunity for intervention then
you have an oppor… you know you can
target your trial. I think the question is, how
quickly can you get there and do you have to use the same
toolset that we’ve been using? And you know I would
argue, also, that you could look
at different… You know we talked
about cyst formation and potential intro-cellularity
as places that could be studied further to
see if it is happening in vitro and in vivo and then that would
change treatment decisions. So that’s somewhat of a hybrid
to studying pathogenesis that seen in vitro not
yet in vivo and does that change your
treatment plan based on how the bacteria’s
behaving in the body? I was probably being a little
too obscure with agnostic as to cause with my statement. So if you look at
the trials where… I know you have an issue
with the inclusion criteria in patients and many of the
trials for antimicrobials for Lyme disease, there’s a
dearth of equivalent information for the non-antimicrobials that
may have equal or better impact on the signs and symptoms. So I think that a little bit
more balance in how you manage that is where I was
going with the, uh, including in the exploration. And it gets at the mechanism of immunologically
based interventions and certainly you’d like to
know what the role of that arm of the host-response is before
just blindly attacking it. Yeah and I think our, you know, the pathogenesis research we
were looking at or looking at advocating on behalf of was understanding those
mechanisms of disease, right. What are the… What is the pathogenesis
of the symptomology? But part of that that the group
put forward was studying immune evasion specifically as an
area that needed further study, because it was significant enough that it required more depth of
understanding before we could… or that it deserved a larger
depth of understanding as something specific
within pathogenesis that they wanted to put forward. I have another aspect,
Wendy, to… that I don’t think is
included anywhere and that is, it’s of grave concern to
patients and treating physicians and even a lot of researchers that in the past the clinical
trials, the conclusions that have been reached, and have
been propagated have been used against patients. Often times those were things
that were used by insurers; also used by physicians
not to treat patients and even though maybe the
conclusions that were reached in the paper didn’t
necessarily seem to reflect what was actually
done in the clinical trial. So how could something be
put into something like this to ensure that that
wouldn’t happen? Because I can tell you this,
patients would be very leery at this point in time
– this is my opinion – to get into clinical trials
because of what was done in the past clinical trials. I think that’s a good
point and that gets to the patient centeredness and how you include
patients in that… in the population
that’s determining what that trial looks like and
also, looking to make sure that you’ve seen enough
– data is a strong word – so you’ve seen enough
activity in some other area like a big database or that
we’re pulling out ideas that look to be working, but
we just want to studying them in a more rigorous way. So it’s a valid concern
and I don’t know… I would look to other maybe
indications on how they protect against this or how
they integrate this into the trial design, but I think it’s an
interesting question. Data… A study is
going to have a readout and you’re not always going to
agree with the readout and just like the trials that
have been done in PTLDS, you know there have been
studies or statistical analysis on what those studies could say and what they couldn’t
say, right. So it’s a really good issue
and I don’t have an answer for you except to say
that, “Yes, we should take that into consideration
and consider how to go forward with
that in mind.” And building off
of that response, in other sectors one
approach has been taken when there is not trust in
the government is to partner with a trusted organization. So this could be a nonprofit. It could be an academic
institution. It may be the government
supplies some funding, but then the actual clinical
trial could be run in tandem with an organization that actually is
trusted by the community. [ Pause ] That sounds like a good idea. I’m just wondering… I mean, I heard everything
you said. I think that’s a great idea. Is there some way that somehow
that we can at least even if it doesn’t contribute bottom
line to Congress, but it’s here that we know that this issue
has been an issue of contention and that somehow that when this
clinical trial is designed – and I don’t know
anything about that. Dennis, that’s your department. But how is that addressed so that we could
perhaps put something that would address that? Because quite frankly,
I would like the science to conclude what is actually
in the data that they produce. I don’t want the science to conclude something
different and I… Unfortunately many of us
feel that’s what happened. I think the trial
questions are proposed in a particular way using
scientific convention and the data are the data
and they either support or refute the hypothesis and then there’s the
peer-reviewed scientific literature that has the
second level review. So I think there’s a difference between a properly designed
trial that shows no benefit and a trial that’s taken out of
context and used inappropriately for policies and procedures. And that’s clear and important
to make that distinction. [ Audio Cuts Out ] – last statement what
you meant by that? I heard your comment about how
unfortunately clinical trials are often used against the
patient rather than for, and if you think of some of the high level higher
enrolling clinical trials with large sample size
randomized perspective controlled, the data
were the data and if long-term antimicrobials
did not show a benefit that’s what the question was designed
to ask and it is what it is. It’s not used inappropriately. The results were what they were
and it’s the application of that that either does or does
not support reimbursement that leads to the problems. I mean I agree with you
that the data are the data, but it’s like saying statistics. You know you can… Give me some numbers and I
could probably say, “Well, it means this or it means
that,” and unfortunately many of us think that it meant “this”
and “that” that was chosen was “that” and even though
there were a number of reputable scientists
who actually went back over the trials and
reported that information, that still did not,
unfortunately, undo the damage that is still being done
today from those trials. I think you have to
really include a lot of different people in your… potentially in your
trial design process, so that people then can
agree up front on what the… if the data says, “this,”
what that means, right? And I think that many
people would’ve looked at those initial trial designs
to which you’re referring and say, “Of course there
wasn’t going to be benefit in that kind of trial design.” And so if you include a
broader group of people and give
them a chance to opine on the clinical trial
design, hopefully… maybe you stave off
some of those problems. I agree with Dennis in that
the data is the data, however, some of those trials people
would argue with the fact that they were actually composed
or comprised of a correct design to really show what people
were saying they showed. Is that a fair way to
characterize it, Pat? Yes, sounds like it. Yeah. [ Pause ] So looking at these two
bullets, I think they could fall under the increase
federal funding. Did any of the subgroups do a
back of the envelope calculation of what funding should
be increased to? It’s never enough, right? It’s never enough. We did not. We did not. How could we do that? We didn’t really know. We didn’t have the
government documents to see how much was spent on
X, Y, and Z. So it was kind of difficult to say it should
be increased to whatever. NIH and a lot of the agencies
do publish their annual spending for prior years. Yes, that’s true. So we didn’t have it now, but
there is information out there. So part of the reason
I was asking is because I think there are
many approaches you could get to an estimate and I
was just curious if any of the subcommittees did. [ Pause ] A process question. So we’re looking at a
lot of language up here. What do you want us to be coming out from this – Because
we could… I could pick two or
three of those phrases where we could spend some
time discussing them or not. But I don’t know
what the goal is. So these are the
proposed actions that the subcommittees
came up with. We’re not asking you to
vote or agree on every word, but if you take the way it’s
written, if you disagree with it it’s important
you let us know. Well, I would say
that “Current data from trials are not
generalizable to clinical practice,”
is a statement, not an action for example. And I also… one I would strongly
disagree with, in many context and maybe not all, um, “And
intensive testing is led to a data set that may not
be representative,” again, a statement, not
necessarily an action. So I guess that’s
what I’m getting at. You know I was thinking
of it in terms of process that we will be able to
finesse the words and do details down the road, but kind of a the
big bucket; like what do we want to recommend to Congress and
HHS Secretary and that’s kind of why I was going to funding, because if it gives us funding
most likely policy experts and decision-makers
are not going to know the details
of clinical trials. So I think this is super
important to have there, but “Is there a broader umbrella that would capture
both of these?” was sort of what
I was getting at. So the top level bullet
is the action item. You know, “Conduct
clinical trials.” So that’s the action
or the recommendation. So I think if you… If anyone disagrees with the
action part of that paragraph, that’s important to bring out. So would… Oh, I’m sorry. The, um… So wouldn’t it be true that
what Rob was talking about, that portion would be a
portion that would be included with the verbiage that
would surround this? So in other words you’re going
to make these recommendations. There’s got to be some
verbiage that explains that. So perhaps statements like
that might be felt necessary and they would be
included in that verbiage. Am I correct? Yeah. They were used
as justification. Yeah. Right, the
thought process to kind of support the bigger
bullet point. If that’s the justification and
we have a minority disagreement with that justification, is
that going to forward the hope to get more funding
for clinical trials or should we be putting together
something that we can agree on and also forcefully endorse when
it doesn’t have spurs sticking out that might rub one of us
or several of us, I don’t know, the wrong way and
make it harder for us to support the overall goal? So that’s the process question. Just to introduce a concept,
if there are different subsets of patients that have different
responses to treatments, then by definition you
wouldn’t expect one subset to be generalizable
to another subset. It may be you dilute out
from the extremes if you try and put them all together. So maybe the goal is,
“Conduct clinical trials that are generalizable to the
appropriate clinical population; because you would never
expect a clinical treatment to be generalizable to
a different population. And so if you just hit it
at a higher level concept, “Conduct clinical trials
that are generalizable to the appropriate population.” In any clinical trial, in order to analyze the question
carefully you need to eliminate as many confounding variables
as you can and so, you’re going to have a rather
well-defined population. It’s always going to be
generalizable in theory to that same set of individuals. There are other individuals
that can be addressed through other designs
and other questions, but you can’t expect one
design to do everything if it includes a
different population. Yeah and we said
clinical trials, plural. But we do need to look
at different populations. We need to look at people
from the West coast. We need to look at who have
different strains in species and different, um,
you know might have different pathogenicity. We need to look at the Midwest. We need to look at the South. Those populations haven’t been
included in clinical trials and, you know, because most of
them were done so long ago. So whether you do a
bunch of little trials or you do one big
trial where a lot of different populations are
rolled up into is a question for clinical trial design,
but I do think you need to get to a clinical trial or a data
set that is more representative of disease today as opposed to
how it was 20 or 30 years ago. I had spoken to three PhD
researchers regarding a clinical trial I’m planning on
trying to do next year on the Dapsone protocol
and when we looked at it it’s exactly
what Dennis was talking about is there was one
group we were going to take out the confounding
variables which is, if you have POTS Dysautonomia
and you’ve got fatigue and dizziness and concentration
problems and anxiety, that can be cause
for many symptoms, but it’s not treated
with antibiotics. It’s treated by giving
FlorineF, Midodrine, Northera,
a bunch of different drugs. So in the trials we were
looking at is looking at those overlapping factors
on the 16.M SIDS model of, if you have food
allergies, for example, with leaky gut you get the same
inflammatory cytokine production you get with Lyme. Well, that’s never been taken
out as a confounding variable in any of these studies. There are people that have
Mast Cell Activation Disorder. It’s never been taken
out of the studies. So to take out these confounding
variables I think is extremely important, otherwise you’ve
got this heterogeneous group of people who they come from
different parts of the US, but they also have
different co-infections. They also have different
overlapping factors and that’s why we were going to
identify in this to treat one of the groups not
looking at those points. Another group, treat them
first for several months to get those confounding
variables out of the way. Treat them and kind of
look at what we were doing and so that’s something
actually I’m interested in looking at next year. Well, and that goes to
big data tools, right? Trying to look at that, trying
to look at the data associated with those patients to see
if you can ferret out things to then test in a clinical
trial, right, beforehand. You have an incredibly
complicated patient population, right. So I’m not sure that I’m
holding you up as the standard by which we should do clinical
trials, but it is something to think about whether you, you
know, how you design it is very, very important and I hear that inclusion criteria is
extraordinarily important. I understand that. We just need to get to a place
where we can trust the data, that it’s a generalizable
set of data. That it works for someone in
Monterey, California as well as it works for somebody
on Long Island and I don’t think
we have that yet. I would say that we don’t. It might be the same, but we don’t have enough
information to know that. [ Pause ] Still stuck on the sort of
generality of the statement. I mean I guess you
could look at it as just leaving it very
general so people can read into it what they want. I think if you were to do
that you might drop out some of the sub-phrases or at
least change them and the term “inclusive entry criteria” isn’t
more inclusive isn’t necessarily I think what I’m hearing
people talk about. They’re talking about different
groups, different geographies, perhaps even different
disease agents and so, that’s not really a question of
“more inclusive entry criteria,” it’s actually more exclusive,
because you may want to look at Lyme disease in California. So I have problems
with the language. Maybe I’m splitting hairs
on this, but I would go for a more generalness or
else say that “we really want to focus on people who have
persistent symptoms following antibiotic treatment based on what we’re learning
from pathogenesis.” That’s where I was going
with trials that are… with the inclusion
criteria appropriate to the target audience. It’s the target patient
population, because they may not be the
same for the group in average. There’s got to be a
way to fix that wording so that you don’t
get the opposite of what you want as a result. I think we want to expand
clinical trials, right. I think we need to… So how about “inclusive
yet selective.” Because I think what
Wendy’s saying is you want to get the whole suite of how
these tick-borne illnesses or diseases might
manifest, but then you want to be really selective
when you do your trials; you’re comparing apples to
apples and oranges to oranges. So “inclusive yet
selective entry criteria.” I don’t know.
It might be confusing it, but… Do you want to capture
the broad heterogeneity, but then within that
splice it up and divide it so you’re comparing
similar groups? Yeah. I think that’s right. So I think if you, uh, if you have subgroups
then that’s important. The key is not enrolling
2000 people in Long Island and considering it applicable
for the whole country, right. And not just having two or
three disease manifestations that present, but
enrolling different groups of disease manifestations,
because they might be… need to be treated
differently and I think… I understand the
wording problem. You know, if we… I’m totally open to changing
the wording to get more… to put more definition around
it so that people are happy with that definition, but
I think it’s, you know, I think it’s important that we
are extrapolating what’s good for the whole country
on a smaller set of clinical trial data. So could we expand
“clinical trials” to include “clinical trials of previously
unstudied subgroups of… ” Populations. Uh huh. “… patients with post-treatment
Lyme disease syndrome which exclude patients
with co-infections.” So you can’t study
co-infections; you don’t want to in a trial of post-treatment
Lyme disease syndrome. So that’s one study, but
then the next study is, “post-treatment Lyme disease
syndrome with co-infections.” So you know I think… So to expand the types
of clinical trials, but each one has to be designed
for a specific question. But if we expand the types,
whether it’s about co-infections or the phenotype
or the geography, but I think what we’re saying
is that for study design to get a question answered
it could be many… They’d have to be
different studies. You need to broaden
the population of people you study
even if you’re doing it in different clinical trials. Exactly. Right? I mean… [ Audio Cuts Out ] I wonder whether we get into
words like gaps or something like that, because ideally what
you’d really want to know is, “Well, okay, they did
2000 patients in this… They enrolled 2000 patients
in Long Island with EM and we know what the
results of those were and maybe we’ll accept
those results; but in California
I’m not so sure.” So you’re looking for gaps where you don’t have evidence
that’s already been compiled and that also might extend
to other tick-borne diseases where we have huge
gaps, for example, we assume that Borrelia
Miyomotoi is going to be… it seems to be sensitive
to Doxycycline, but we don’t have any
information really from trials for that organism yet and so on. So I think you want to
keep it as multidimensional and by maybe emphasizing gaps and where we don’t
have information gets out of the issue of why
we’re looking at a budget and I was looking at
this and say, “Well, we’ve got a bunch
of clinical trials.” So I think you have to
think, um, how to phrase that in a way that’s… that we’re filling a gap. This is something
that hasn’t been done. And I… So I think
I agree with that. I don’t think that that’s
a, you know, the hugest… probably the biggest gap is
the people who are still sick after antibiotic
treatment, right? That’s the… And you can study that
in many different ways and then you can break out,
you know, are you studying… Do you want to study acute
patients in California or PTLDS patients in Wisconsin? But the concept is still broad. If we need more specificity around the language
then I’m fine with that. Your point is well taken
that this is gap… these are gaps. These are populations that
we don’t have any data on, but we’re recommending
how they be treated even in the absence of data. So can we gather
more data on this… these groups of people
so that we can treat them more appropriately? [ Pause ] So would we suggest
changing the language to… I think we should. “Conduct clinical trials to
address gaps in data that, um… ” I’m thinking out loud
here, so let me think about this off-line a sec. [ Pause ] Wendy, why don’t you say,
“Broad and clinical trials to include underrepresented
populations?” That’s a good place to start. I think there needs
to be some wordings that doesn’t get misconstrued
as one-size-fits-all and you may not be able… It may be optimistic to
think one large trial even with big data could
answer something that it wasn’t designed
to answer. So that’s why I was
trying to go with the, “Conduct clinical
trials appropriate to the target population
that you’re trying to reach.” And if there’s more than
one target population, you can’t imagine that
that would work easily in a single trial. Depending on what it is. If you’re looking at
regional differences, yes, you could probably do
that in the same trial and just enroll different
cohorts, right. So… But in PTLDS it might make
sense to do one large cohort in one place and then broaden it
out to see if that’s confirmed. So that gets at under
the “appropriate to the target population” and if the target population
is homogeneous then it’s easier to address than if it’s
vastly heterogeneous and if you have opposite
extremes in a single trial they
could cancel out the results on a total basis and defeat
your purpose of trying to reach target populations that
are different from each other. So it’s a concept
of “appropriate to the target population”
that I’m trying to get at. And I don’t think they have
to be mutually exclusive. I can figure it can
be a “yes and.” So you can have “broad and
clinical trials appropriate to the target population,”
and you could also have “broad and clinical trials
to underrepresented or underserved communities.” So you can have both of them. Yeah and then language to
say, “including,” you know… PT… Not PTL. I would say probably a
broader population than PTLDS, but we could include PTLDS plus
additional populations including continuing symptoms after
initial antibiotic treatment and geographic diverse… geographically diverse
populations. And there seems to be a
dynamic tension between broaden and target, because you’re… So I think it’s “conduct”
not “broaden.” “Conduct clinical trials
to the target population,” and then you’d want to get
something along the lines of “Ensure appropriate coverage for the different
target populations.” That sounds reasonable. So maybe we could get
it in one sentence. I would leave the
beginning part, the “Conduct clinical trials
appropriate to the target or target population,” and then
I would just do another bullet, like then hit enter, and then
say, “Conduct clinical trials to serve underrepresented
populations.” Do you think it’s
clear what’s meant by underserved populations? Because that means different
things to different people and we mean it in a very
specific context here to the disease. I don’t think it’s clear
from that bullet right now, but I was thinking if we get the
high level stuff we could flush that out later. But it could include,
you know, chronic Lyme that does not fall into PTLDS. It could include
the co-infections. It could include children. It could include pregnant women. So a lot of different
groups are in there. Previously unstudied populations
or little studied populations. And if you want highest level,
you could just put an “S” on the first population and
not have the second bullet. I would rather define a
few situations as opposed to leaving it up
to interpretation. So I think… You could actually have
more rather than less if you leave it vague. Depending on who’s
doing the interpreting. So… Yes and… It’s a win-win. Add a “Yes” and keep the second
bullet for now or add an “S”? [ Laughter ] So for that one I
would just delete “such as” and just turn it… Nope. The one before. I would say, “low
incident states” and that’s what you were
referring to before, “low incident states for Lyme
disease” would be one of those. So in the line above it end
it with “target populations” with an “S” and then
for the second line, “Conduct clinical trials to serve underserved populations
including chronic Lyme, co-infections, children,
pregnant women, states that are
underrepresented, etc.” How do you want to
phrase that, Pat? Well, the terminology
CDC is using now in their surveillance is “low incident states”
or at least it was. I don’t know if it’s
the same now, but that’s what it was
a month ago anyway. And is there a reason
to use that as opposed to geographically diverse or in? I mean, yes, because… Well, I mean I think because I
thought what you were looking for is to ensure California,
the Midwest, the South, those areas that traditionally
are not considered to have Lyme or to have very low Lyme if
they have it and I thought that that’s what you were… It is. I’m just thinking
the terminology might be… I would rather have it, I
guess less or more agnostic as to the incidence and more
just geographically determined based on geography. Well, yeah, but how… Determined based on geography
doesn’t, that I know of, have a definition; whereas
“low incident states,” they have a definition. I mean they’re defined as
in a certain way, you know, for number of cases
to have low incidence. That’s why I mentioned it. I don’t know geographically. I think everything… But everything is low incidence
besides those 14 states, right? Say that again. I think everything is considered
low incidence besides those 14 states. Yes. Correct. Yes. And so you could… I want to make sure we do
something that’s far and away from those, from the
high incidence states and not just maybe in
the associated areas that are close to those states. So that’s… Are you talking about
like contiguous? Is that what you mean? Yeah. I’m talking about
different geographic areas as opposed to just being able
to do it around those 14 states. So that’s why I’m
thinking of trying to do it without having a… having it a little more
specific as to where we want to test, but I could… Could we just add,
“geographic context” for now and leave it totally broad? I think so. Is that something we can
define in the bigger report? Uh huh. Like discuss when
we write the bigger report? Yeah. So I would add “geographic
context” and then also “co-infections or other
tick-borne diseases,” so we don’t lose those. Yeah, I think other tick-borne
diseases, because again, you don’t want to close the door if in California it’s actually
a Rickettsia that’s causing the tick… the major tick-borne disease. So I think since we’re
weaving those in that has to appear somewhere in
here if you’re talking about looking at treatment. Um, and the other thing is, I think chronic Lyme disease is
the sort of term that will… I would have a hard time signing
onto, because as I said before, I don’t know what
is meant exactly and I would say pick something
that’s more generic like “people have symptoms
after standard treatment,” or something like that. Along those lines, a
second bullet Rob brought up about the statement,
“current data from trials not generalizable
to clinical practice.” I have problems with
that as stated, because Rob told us how
he uses certain trial data to inform the appropriate target
population that he’s treating and yet not to the
inappropriate target population. So I think that’s covered
under the bolded bullets on conducting trials and should
be removed as the second bullet. I think those bullet
points go to context for the written report
and I don’t… I think we can have a
separate discussion about them. I don’t know that
they’ll be included, but I think they were more as context setting
for this process. Well, if they’re included
I don’t agree with them. Uh, which is… Okay. I was saying
that I don’t know that they will be included
in the final report. So would you… So you are disagreeing
with the fact that we don’t have a fully
representative data set? You don’t believe we have
a problem in our data set? I just think we should spend a
little more time wordsmithing the second bullet if it’s
going to stay in there. What about if we vote just
on the top level bullets and leave the bottom ones in
as placeholders for context so we can remember this
conversation and flush it out later, um, timewise. John and I were just
talking about what to vote on and we’re thinking the
top level bullets only. I’m fine with that. All the bullets? No. Just the… I was thinking the top two. Just the big bullets. I don’t want to beat
a dead horse here, but regarding underserved
populations, I do have a concern for those with a chronic
fatiguing muscular skeletal illness with cognitive
difficulties who do not have a
specific clear diagnosis. Labeling them for me
as chronic fatigue or fibromyalgia is only
helpful if you have, not just treating symptoms,
but getting to the etiology. So I think there is an
underserved population in some of these chronic diseases with the fatiguing
muscular skeletal illness with cognitive difficulties
which would go on to the CFS fibro groups. So I don’t know, again,
if that’s appropriate as an underserved population, but it’s about 5% of
the United States. [ Pause ] Wendy, do you have a feeling
on that or you’re thinking? I think that’s a discussion
for maybe a later day. Parking lot? Yeah, parking lot. Parking lot. Are we settled… I’m a little confused on
what the bullet is now for the second bullet? Is it, “Conduct clinical
trials appropriate to the target populations,”
which is fairly generic or is it the one under
it which is much more… has many more pieces to it or is
it your top one that you started with which still has “inclusive
entry criteria” in it? We can decide, but I was
thinking that we want to pull out the ones we want
to vote on to the bold. So if we want to
vote on, you know, the “Conduct clinical
trials appropriate to the target populations,” I think we bold it
and move it left. So I think we should
have a discussion about what should be bold
and what should be moved left and everything else
will just be context to help us inform
flushing out those points. And so the top level of the
two solid bullets you’re talking about? Okay. Exactly. Exactly. I would
agree with that. And if we want to move the “Conduct clinical
trials appropriate to the target populations”
to the left and bold it, I agree with that. I think we do for… to answer the concerns. But not the one below it, um,
since there’s some language… Or maybe we leave,
“Conduct clinical trials… ” I can’t read it. Leave the second one,
“Conduct clinical trials to serve underserved
populations,” and then space, um, sub-bullet with listing
what those populations might be? Just as a placeholder
so we remember, but it’s not actually saying
like your objections Rob with the “Chronic Lyme?” Well, I still… I’m not sure also that the word “gaps” whether we
decided whether that was helpful
or not to have… to give this some sort of,
“We’re looking for areas where you’re going to
get the maximum benefit from doing a clinical trial.” You’re going to look at
everything that’s both emerging and that’s coming out and say,
“Well, these are the gaps.” And I think that to me
would make more sense if I read something like,
“Yeah, and they’re recommending that there be funds put into
clinical trials for gaps in understanding, you
know, effectiveness of different therapies.” So would you add that
to the second bullet, “Conduct clinical trials where gaps exist using more
inclusive entry criteria?” [ Pause ] So the second bullet,
“Conduct clinical trials where gaps exist,”
and then take the “using more inclusive entry
criteria” as a sub-bullet? You know I… We could probably spend hours on
this phrase, but I think that, as I said, that I
have trouble with the “using more inclusive entry
criteria” has implications beyond what you… So I’m just trying to get
away from that language. It depends on if it’s done
“per trial” or “overall.” Right? It was meant to
be “overall” as opposed to “per specific trial.” Right. So I think we’re
agreeing violently on that. The question is how do
we put it in the nomen… How do we phrase it? It’s the phraseology. Why not just using “entry
criteria representing… ” And then we don’t
say more or less. It’s just that they’re
appropriate. [ Pause ] Would delete “more” from
second bullet that’s bolded? [ Pause ] Where does it occur
the second time? I’m looking at the second
bold full bullet with “more inclusive” and
just “entry criteria… ” And just take out
“more inclusive.” Yeah. Because you want the
appropriate entry criteria to the question you’re studying. Exactly. Maybe more, maybe less, but they’re appropriate. [ Pause ] Yeah, and you can probably get
rid of “inclusive” there too. Because more inclusive
might be inappropriate for the population
you’re trying to study. So it’s… Yes, but not when you’re looking
at the whole data set, right. So you want to crea… Yes, I think… Again, we’re violently
agreeing we want to test more populations, even though in a particular
trial they might have tight inclusion criteria, right? I think so. So I make a motion to vote
on the bold ones that are to the left, not
on the sub-bullets which will just provide context
so we can further flush them out and remember this conversation. Wait, before we do that
though, the target population, “Conduct clinical
trials appropriate to the target populations.” I think, uh, we… I just don’t know
what that means. So which target populations
or appropriate to other target populations that
have currently been studied or? I thought that was crafted
to replace the second bullet. Because there was
some concern about the “more inclusive population,”
so we grafted in a broader statement to say,
“clinical trials appropriate to target populations,” and then
we had sub-bullets under that which talked about examp… I would see them as examples
as “potential population.” So maybe “Conduct
additional clinical trials appropriate to… ” [ Pause ] Yeah, why do we need those
two different bullets when they say just
about the same thing. Uh huh. Yeah, that’s one thing. Yeah. I think he
makes a good point. So should we cut-and-paste
the sub-bullets under the second
thing to go under the “conduct additional
clinical trials” here? I think that would do it. “Conduct additional
clinical trials appropriate to the target population
where gaps exist.” And then the sub-bullets,
I think. I think that does it. Let’s see what it looks like. [ Pause ] Could I make a comment on the,
you know, the that indication that you made, Kristen, as
we have done before talking about those sub-bullets
and they would be in the verbiage surrounding
these. I just want to make a
statement is that I… I have a real concern that
we’re purging the word “chronic Lyme disease”
out of our… what we’re doing and quite
frankly, at this point after 44 years, I can’t help it
that these people haven’t come up to the conclusion of
what really is happening and whether it’s chronic or not. That’s not the fault
of the patients. And so we need to ensure that
in the verbiage that the word “chronic Lyme disease”
is in there and post-treatment
Lyme disease, well, that’s fine for the research
study and so on and I understand at times they want to use
that for various things, but they are excluding a
whole segment of people with Lyme disease and
the only term we have to include all those people
right now is chronic Lyme. It’s a kind of a thing
that everyone kind of knows what chronic Lyme is, so it’s not scientifically
defined. So I just want to make sure
that when the discussion comes up it’s in there and if
people don’t agree with it, well they’re certainly entitled
to have a minority report or if only a few people
agree with it then that will be a minority report. I hundred percent agree
that chronic Lyme has to be addressed head-on
in this report. In this section, though, we
are looking at recommendations that we agree on and think
are priority for pathogenesis. I don’t know if that would
be the right place here. So that’s why it’s
not bolded here. But in the report itself,
I think we would be remiss to not call it chronic
Lyme, address chronic Lyme, define it as best we can and
point out if it’s nebulous, how we could improve that so
we all have shared terminology going forward. Thank you. That was my concern. Thanks. Yeah, my concern
would be if we’re talking about going forward that we may
need to use different language than has been used in the
past which is polarizing. I would love, if we could
crowdsourced Lyme, L-Y-M-E. If anyone could come up with
an acronym that would make Lyme for this complex
suite of illnesses, that would make our
lives so much easier, because Lyme is a misnomer in
many ways, but you don’t want to lose the historical search if you’re looking
through literature. So if any brilliant people
out there can think of L-Y-M-E as an acronym to get our whole
suite of Lyme-like illnesses, I’ll be forever in your debt. I hate to say that I
would be opposed to that, but I would be opposed
to that, because again, talking about historical
context, it took us many years as advocates and patients
to get Lyme disease to become a common parlance and
to be recognized and to now lump in all kinds of other things
that may or may not fit with that, I think that
would be a huge mistake. We’re just getting to where
people say, “Ah, Lyme disease. There’s Lyme disease
in California.” I just heard that the other
day, Wendy, from a Californian. “I just found out.” And my point being that that
would be why I would not want to do that. We’ll take those
off-line and maybe come up with a different part of the
report where we could flag some of these differences or
recommendations on terminology, but for this one we
should get back to voting on recommendations for the
pathogenesis subcommittee. And so I want to make a
motion to approve inclusion in the recommendations, the top
level bold – things that are to the left, not the
sub-bullets that are not bold. Those are just placeholders to help remind us what
we were trying to say with a high level
of recommendations. I think we worked
on clinical trials, but not on the animal models. So, the question is, do
we want to just work on… approve the clinical trials
and then go to animal models? Yes. Right. So any last discussion
on the clinical trials? Yeah, I don’t think it got
changed to where it needs to be. So, “Conduct additional
clinical trials appropriate to the target populations
where gaps may exist.” Right. We wanted to
combine those two and then including chronic Lyme
in children, pregnant women, [ Pause ] geographic context. Yeah, so put that up… And actually, I think
it can just be included in that solid bold, can’t it? And that way it can… It will get approved
as part of that. Um… No, because there
were some objections to chronic Lyme for this. There were objections to
just the chronic Lyme. Okay. Um, Kristen, I don’t
think you made a formal motion. So I’d like to make
a formal motion that we approve the
recommendations in bold with the understanding that
the sub-bolded, sub – sorry – the sub-bullets will be included in the discussion
portion of the report. Right, where they may not have,
you know, uniform support. Some of them will remain
controversial probably, but yes. [ Pause ] I second that. alright. Ready to vote? Yep. Okay. We’ll do a roll call
vote on the second part, the “conduct additional
trials” part. Bob Sabatino. Yes. Scott Cooper. Yes. Ben Beard. Yes. Wendy Adams. Yes. Rob Smith. Pat Smith. Yes. David Lieby. Yes. Allen Richards. Yes. Richard Horowitz. Yes. Dennis Dixon. Yes. Kristen Honey. Yes. John Aucott. Yes. Passes unanimously. alright. Now let’s go up to
the top, the first priority. You want to read
that one more time? Yes, let me get my
computer back up. Alright. “Promote
research on animal models of on B-Burgdorferi
infection and the mechanisms of disease processes in humans
with an emphasis on pathologies that are currently lacking,
such as Neuroborreliosis.” So discussion on this
before I entertain a motion? I just wanted to… Sorry, my slides
won’t come up here. [ Pause ] I think we want to… I think the first… Okay, so did we… I think we combined
those then, didn’t we, “insufficient understanding
of mechanisms of disease?” No, we wanted to kind
of combine the first one which is what is written and
then the study of mechanisms of survival, including
“infection processes and tolerance to antibiotics.” So we could prob… I think build that into
the first bullet, um, [ Pause ] “promote research on
animal models infections and the mechanisms of
disease processes in humans with the emphasis on pathologies
that are currently lacking, including Neuroborreliosis
and ability to survive during infection
processes and tolerance to antibiotics and
other stresses.” Um, I’m sorry. “An ability to survive during… ” “Infection processes
and tolerance to antibiotics and
other stresses.” [ Pause ] And maybe we could do… We could say, “EG
Neuroborreliosis, infection processes tolerance to antibiotics,” or
something similar. Just make that a list as
opposed to two separate ideas. Would it be a possible… I don’t know if I’m
supposed to interject, yet. Would it be possible just
to stop with the first part which you had through
“Neuroborreliosis,” which is what we
started to look at and then consider the second
parts as things that would be under the sub-bullets
for discussion… further discussion, rather
than get hung up on more of the language there? In other words, if you’d just
end it as you did with a bold without bringing in
the second phrase that you’re adding right now,
which is new on the screen. Yes and to be clear, it was
our second recommendation from that list. So I just want to make sure… We wanted to combine the two, because I think they’re
the same idea with different, maybe,
sub-bullets. So… So let me move
it over here, Wendy. I think it might read
a little bit better. [ Pause ] So do you, Rob, object to
calling that out specifically, the concept of the bugs
ability to react to antibiotics or what specifically are you… I don’t think it’s necessary,
because again, we’re trying to look at a plethora of
possibilities as we look at pathogenesis and clearly
in the report there’s going to be discussion of
that possibility. It comes back to the same
issue, what you’re really trying to get is the broadest
view of the science of what’s the pathogenesis
for, if it’s Neuroborreliosis, how much of this is due to
active infection at some point versus residual from active
infection or some other process that is set in motion. All of the things you’ve
already alluded to under… in prior segments. So it seems to be getting
too specific in that bold one to get easy agreement. It would be much easier, just
personally, if you’d stop at the Neuroborreliosis. It’s implied that you’re
going to be looking at different disease
processes as part of understanding
the pathogenesis. So could you get at that by
stopping at Neuroborreliosis as we had it before and
then taking the new section that was added and just ind… like right indent
that whole part? Yeah. I also have a question
regarding the wording of “pathologies that
are currently lacking.” So, would it be better
to say pathologies that are incompletely
understood, because microglial
activation, Mario Philippe’s work; I mean there’s quite a bit
actually on pathology – CXCL13. I mean there is work
on what’s happening. I just don’t think we have
the full understanding of it. So is it just better to say,
“incompletely understood,” or do you want to leave
it in that language? I’m fine with that change. Okay. But there was a thought
process around the specificity and that is sometimes when
you broaden then it’s subject to interpretation and so
these were very specific based on what our group recommended
as scientifically important to research and understand
better. So that’s, I guess, a
little of my restraint around just putting it into a sub-bullet
that’s not discussed is that we were very specific
in what we wanted to look at, at least for this portion. I think the top bullet point
was a little more broad. We did call out Neuroborreliosis
because the lack of an animal model there was
thought to be very important and restrictive to what we
know about human disease. [ Murmuring ] So I think we can… could probably live with it
so long as we can address it in the text of the report. I think that’s what
I hear might be… you might be more
comfortable with. I just, you know, we were
specific for a reason and that’s because it’s thought to
be important to study and to determine whether it is or is not a part
of persistence… When you put in that specificity
you’re picking essentially… picking a winner if
you take the phrase which we don’t really know. And so that’s my point,
is you want to look at… There’s other research
going on in terms of things that are triggered, in terms of
autoimmune or central syndromes, neuro-disregulatory syndromes,
and so that’s all I’m saying is that could be in the
text along with… You know you could even
discuss prioritizing those, but I think that for something
that’s very, you know, that’s a major bullet
that should be more open to scientific inquiry. Yeah and I think we were
trying to do both with this, is give a broad category
and then specific examples of where we thought additional
research should be conducted. So I’m fine with being able
to address it in the report and not approving
it in the bullet, but it was a specific
recommendation of my group; so I don’t want to mischaracterize what
we were recommending. Do we have a motion? So moved. So the motion is
to accept the bolded parts for voting with the un-bolded
part to be kept for production of the working report. Yes. Second. alright. So roll call votes. In favor, Bob Sabatino, yes/no. Yes. Scott Cooper. Yes. Ben Beard. Yes. Wendy Adams. Yes. Rob Smith. Yes. Pat Smith. Yes. David Lieby. Yes. Allen Richards. Yes. Richard Horowitz. Yes. Dennis Dixon. Yes. Kristen Honey. Yes. John Aucott. Yes. So unanimous. So we went a little long on
that, but it was worth it. Progress is worth it. So our next group to
report is access to care. Do slide 19. Yep. Give me one second. Whenever you’re ready. Thank you. There you go. Okay. Um, our potential actions or recommendations were pretty
much centered in this key theme that we came up with
which was access to affordable medical care. The group really thought it
was important to emphasize the “affordable” part of that, even though our subcommittee’s
name was access to care services and patient support, but the
“affordable” part in order to capture as many
patients as possible, we thought was very important. So under that with regard
to – and just to say, it was difficult, I’m sure as
the other subcommittees found, to really narrow this
down to just a couple here and we were really… It was a lot of work
that went into it. People were really
attached to certain things. I will point out one
that didn’t make the cut, but we still consider very
important, but I was glad to see with Wendy’s that it’s probably
going to get captured there; that was and it fell
under access to affordable medical care. It was “underrepresented
and high risk populations.” So and we had under that
pregnant patients, children, the elderly, military,
active-duty military as well as their families and
veterans, migrant farm workers. So I think if… Yeah, that’s good to know that
that’s going to get in there. So we sacrificed it from our
part, but glad to see it. So if you could go to the next
slide and actually the one after that would be great. Yep. We’re really thinking… So we’re looking at
the issue of federal and state government barriers. So with… Really those first three,
one, two, and three we see as one recommendation,
because it’s an ask of the CDC on their website and as, you
know, the educator in a lot of instances combining
those three and asking them to do that, because it goes to
that issue of inappropriate use of the surveillance criteria
as diagnostic criteria. So going back to language
that existed in 2011 that distinguished that
difference and with that I think it was something
that was discussed this morning that was agreed upon, kind of
the coexistence of the ILADS with the IDSA guidelines on the CDC website
linking to both of those. And with that we would
add then drawing attention to the footnote with
regard to that idea of, this is individualized
medicine, you know, particular that patient. They are guidelines,
recommendations that it’s voluntary
adherence to it. It really goes to
the clinical judgment of the physician working
with that particular patient. So and it’s… While that was IDSA
put that footnote in, it would be something,
if it was possible, that ILADS would also have that
same kind of disclaimer to it, um, with it so that it was clear that these guidelines
are guidelines and that those exceptions
exist with regard to physician judgment. So those… Yeah, we’re really
seeing those combined since it is asking the CDC
to convey this information. So that’ll be, yeah… That would be just
one recommendation – all those together. [ Pause ] Okay. And then the next one? Okay, so then we’re
going to again combine… We’re looking at
funding basically. So where we had the center
of excellence we also wanted to allocate the funding. So we’re taking number
five and seven, I believe, to get funding increased
in the area for tick-borne disease
research, treatment, prevention proportional
to cancer, HIV, and AIDS. That was our second ask
to allocate the funding. [ Pause ] And we can call these
recommendations, correct? Uh huh. We can call them
formal recommendations. So instead of potential
action one if we could call that recommendation one, please. Yeah. [ Pause ] And then the last one for
us would be, um, which… Some of us spoke during lunch
about DOE, federally or not. It’s discrimination against
patients, students due to Lyme and tick-borne diseases and I believe Pat had
something to add to that. Uh, yes. I did have a little
bit of this discussion on the call last Thursday
about this and reading through their report
I saw some areas and I thought there could
be a very much more… a very specific recommendation and so this may not
be the right wording, but this is what I
had come up with, “Congress directs the Department
of Education to investigate and establish policies
which protects students with Lyme and/or other
tick-borne diseases from discrimination and
ensuring their equal access to education.” And it’s a huge issue folks. Our kids with Lyme are
discriminated against every day in public and private schools
and it’s heart wrenching, because they not only have
to deal with their disease, but they have to
deal with the fact that they’re not
getting the education that the districts are supposed
to provide under, you know, public education and me
as a former board member and educator it’s
very discouraging. So I felt that we needed to
be perhaps a little more stern with that kind of
a recommendation. I don’t know what everyone
thinks of that, but… Yeah, that was for the job
discrimination and also for the students in
protecting them from that. Pat and that would just… So we’re just getting
at students… discrimination against students
of all ages, but we still, I guess, with job
discrimination whether that would be covered also under
the American Disabilities… with Disabilities Act, whether
this with chronic illness or any type of disease
and discrimination there that may exist, but whether it’s
being enforced might be an issue and a recommendation. And I understand the jobs and
that’s certainly part of it, but considering about
30% of the cases that are now reported
are children and it’s totally unrecognized
– I can tell you this as a former board member –
totally unrecognized everywhere. They have no idea of
the needs of these kids, what kinds of symptoms that
they have, how that impacts on their education, and you
know how disruptive it is and what they have to go through
just to get an education; whereas they can barely get
out of bed most of the time. So that’s why I felt
this was so… I mean you do it
however you feel, but I felt we needed something
very specific in that area so that whatever policies they
have in place they could re-look at those policies – perhaps,
I don’t know, make some kind of additional recommendations
to ensure that maybe Lyme is recognized in
that area as needing that help. I mean they already… The DOE has to deal with it like
under I think 504 and things like that, but other than that
I don’t think they understand what’s really happening there. Pat, would you read the language
that you came up with again so we can add that
as a sub-bullet under potential action
nine please. Sure. “Congress directs
the Department of Education to investigate and establish
policies which protect students with Lyme and/or other
tick-borne diseases from discrimination and
ensuring their equal access to education.” So, I’m sure there’s a
couple of words I missed. [ Pause ] Discrimination certainly
isn’t good. Is it allowable now under law? Is it allowable? Probably not. Um, but I think that… Unfortunately, I think
it goes unrecognized in these circumstances
and that is my concern and so let’s say we do this
and let’s say Congress agrees and they charge the DOE or
whatever with looking at this, then maybe they can find ways
to make it a little more, I don’t know, specific or
maybe they can even say, “Okay, we’re going to investigate
to see if it is, you know, if this is indeed happening,
how can we correct this?” I think what we find… This is a huge problem. People… Kids lose
years of education. They can’t go to school
for a whole entire year. Certain districts are really
great about working with parents and accommodating that particular child,
but it’s not uniform. This is a huge issue and
I know multiple people for whom their children have
lost at least a year if not two of not being able to
set foot in a school because they don’t have
the energy to do it. So this is a, I think a very
good specific recommendation to look at that could really
be impactful for children to make sure that they
can learn and catch up when they hopefully
can get back to learning. That makes sense. I just feel like it needs
something on the explanation for the discrimination. Is it because of excessive
time lost for class? I think it’s the
ability to accommodate… Like in California, it’s an
Individual Education Plan, right. You need an IEP to
accommodate for this and that often times
requires more… It always requires usually
more district resources and so when you don’t have
a definitive lab test that shows you have something,
it’s much easier to say, “That person doesn’t
need an IEP. They need to go to a class
for behavioral problems or something of that sort.” So it’s discrimination, but
may be more accommodation. Well, that’s what I’m getting
at, because that’s sort of a loaded term and if you
could defuse that and say, maybe it’s talking about making
Lyme and eligibility criterion for an IEP rather than
for discrimination. I would defer… I mean I would like to
know what Pat things because she’s been dealing
with this for a while. No. I mean basically
a lot of students with Lyme disease will… Some will get IEPs, but
some will get 504 which is under the federal government. But I think that
it’s not really that. We’re not trying to make that,
because that already exists. The ability to get either
approved under an IEP or a 504 is already what the
child study team will make a determination of,
but the issue is, even after those determinations
are made often times they are… They’re not administered in the
same way; for example, you know, in my time on the board
I saw many students, not only in my own district,
which was pretty sorrowful for me, but in other
districts who… You know they were told
that their doctors, their physicians were not
qualified to make this diagnosis and doctors would be… The school doctors
would be brought in to overrule the
treating phys… the child’s treating
physician despite the fact that they were licensed
physicians, they were board-certified,
and so on and so forth and then these students
had massive problems, because there became a battle
over, “okay,” – and depending on your state -over
“who might win.” Now to me what that’s done,
that’s taken away your… you as a parent now, that
took away your ability to direct your child’s
healthcare because now you had
to acquiesce. I never saw that with any
other disease in my district in my time, never ever and
it was just amazing to me that this transpired and I hate
to say it, but I also saw it in a particular court case which
I really can’t get into it, but basically the bottom
line is, again, it had to do with a child with Lyme disease
and what was happening there and you know it’s
just horrifying, because the parents… You know my own child
was out four full years and two partial years of
school of her life were gone. And so I witnessed it personally
and also in my capacity as a school official, and again, when you can’t always
even convince the people in your own district
that this is an issue and it’s problematic, you
know, it’s very difficult to go out there and convince others and the reason is
because Lyme isn’t… wasn’t at least – maybe
now it’s changing a tidge – but it wasn’t considered serious and that they couldn’t
possibly have symptoms that would be disruptive, for
example, psychiatric types of symptoms and things
like that. So anyway, I just
think we have to be… If Congress doesn’t
like this or they… You know obviously they
don’t have to do it. It’s a recommendation
on our part, but I feel so strongly
that our… You know the best people in
this whole world, our children, are just not looked after
by anyone in authority and that’s what I have seen. Very few people in authority
have taken on this kind of problem and it’s been
dependent upon parents and upon advocates in
order to do this and again, I will say it’s why
I’m sitting here today and the same things are
happening over and over folks. That’s the whole problem. My kids are long adults as
they would like to remind me when I try to run their
life – but anyway. But you know what? Same stuff. I can pull out the talks
I gave 30 years ago that are still applicable and… Pat, I think we need
to stop here, because we do have agreement… Sure. Sorry. … on keeping this in. Because we sub-bulleted this
I think we have plenty of time for discussion whether we
finesse it as discrimination or accommodation or in-between. I don’t think we need to
vote on the sub-bullets, but we did capture them. The one thing to clarify in
the notes that I see is DOE – I believe it’s an acronym
as Department of Energy. So I would do DOEd with a
small “d” for Department of Ed. Yeah. And then do we want
to recap and try to see if we can get consensus
on the big ones? Sure. Okay. So in terms of process, are we
discussing all of these or… because I have some
discussions on the first one that we went through there. I think we were just going
to bundle them right now. I think Coop was going to lead
us through that, Coop and Bob, and we’ll have discussion
on each of these three. And again, I would remind the
working group to not get hung up on the things that
we sub-bullet in, because those are
more placeholder notes so we can remember and we’ll
have plenty of time to wordsmith and finesse that, but it’s
really the top level ones that we’ll be voting on to
include as recommendations and now we’ll kind of try to
bucket these three into language that we can all agree
on for recommendations. alright. So yeah, I
think, like I said, what we’re thinking is… I mean since this resides
with CDC and you know we’d like to see you know
in that area of the website and
I’m not familiar. This came from our subcommittee. I’m not real familiar
with that 2011 language and I’m not sure why
it’s not there anymore, but I think that’s
getting that message out, because I think there
is agreement on that, “The use of surveillance
criteria as diagnostic criteria.” I mean that’s what I seem
to hear from the group that that’s a problem. It shouldn’t be used that way. So I think you know… And then with the other
things, if we are in agreement that the ILADS and the IDSA
guidelines can be linked, both of them, as opposed to
just IDSA, on the CDC website and then like I said before,
just kind of drawing attention to the footnote and if
ILADS would also agree to have a footnote with regard
to their guidelines as well. So could I comment on that? Yes. Because actually we
don’t link to IDSA guidelines. We changed our policy on that. We actually link to NIH as the
kind of clinical lead in HHS and so, you know, our
preference would be for you to change this to… for NIH, the NIH website. We don’t link to any
treatment guidelines and our preference is… would be for us really to… I mean we’re the
prevention agency. We take ownership of prevention,
of surveillance together with CSTE and you know we share
diagnostic responsibilities, but we’re not a clinical
center and we kind of came to the hard realization of that
and so currently we don’t link to any treatment guidelines
and our preference is… isn’t, but to more
appropriately to link to NIH because they’re the ones that have conducted
all the clinical trials and we really follow their lead. So our preference would
be for this to say… Just change from, “CDC
to NIH” or whatever. But we don’t link IDSA or ILADS
guidelines and then secondly… Actually, this should
be in the first point. The 2011 language I’m
confused about that, because this was actually a
change that came more recently and it wasn’t from
the Lyme program. It was from the part of CDC
that does all surveillance and this was a uniform change
to all case definitions. It wasn’t unique to Lyme
and it was currently in there previously
was a statement that these case definitions
shouldn’t be used for clinical diagnosis. They’re for surveillance only. And I think the program
that changed that was because everyone felt like,
“Well, this is self-evident,” and clearly in Lyme disease
it’s not self-evident, but that was the view on
that and no clinical… no surveillance definite… case definition’s ever
been drafted or modified around clinical diagnosis, because it’s two
different things. And I understand the issue
with Lyme and that’s why in our recommendations
previously this morning we talked about having that
post-head that, you know, that message specifically. But the 2011, that
doesn’t strike me as when that change was made. It was more recently and so at
least we should confirm that. But that’s kind of the
context on that one. It was CDC surveillance-wide,
not Lyme specific. But the other… But you ought to check… Pardon me. I didn’t realize we
linked to guidelines. Pardon. I did not realize
we linked to guidelines. No, you don’t, but we’re
saying we linked to NIH, because you’re the clinical
center and we don’t link to any treatment
guidelines anymore. We don’t either. We provide the evidence and other societies
make the guidelines. So I would be surprised if we
did link to the guidelines. Okay. So your preference then
would say that it shouldn’t be at any federal website, because
I’m saying it shouldn’t be ours, because we don’t take
lead on treatment. So I want to push back
there a little bit in that we should think of a
federal government somewhere to look at the different
peer-reviewed guidelines that exist and the
National Registry of Guidelines will be going down sometime next
month, because of funding. So whether it’s CDC or
NIH, the National Registry of Guidelines won’t exist in
a month and I think the role of federal government, we
should point people to somewhere where there’s peer review
treatment guidelines; whether CDC, NIH,
or somewhere else. I agree with that and I
especially agree with that, Kristen, because from what
the information I’ve got from the National Guidelines
Clearinghouse is they’re looking at possible stakeholders to
take over their guidelines and after reviewing some of those stakeholders I don’t
think they’re stakeholders that we would want
then and think that had the patient’s
best interest at heart if they indeed took it over. So I would like to hope
that perhaps, you know, NIH or someone like that
would put up whatever; and to address the 2011
surveillance criteria, I do believe, Ben, that was
the last time that it included that statement and that 2017
was the first time I ever saw that they had removed that
statement from the 2011. So you’re saying that
it was pulled down. See, I remember when it was
changed and it was not in 2011. I remember when it was taken
down and it was more recently than 2011, but you’re saying
it was originally put up in… Yeah. I’m saying it was
actually on the 2011 CSTE – you know how they have in the
corner number such and such when they adopt it – it
was, I believe, I’m 99% sure that it was on the 2011 and then
when the 2017 came out I kind of freaked out when I read
it and said, “What happened? It’s no longer there,” and I
asked you and you explained to me what had transpired. I have the links for both
if you want to see them. The actual language that
was on there from 2007, which is exactly the same one. This is from MMWR. “The surveillance case
definition was developed for national reporting
of Lyme disease. It is not intended to be
used in clinical diagnosis.” That was the wording that
was on the MMWR in 2007 and I have the link for the 2011 and that was the last
time I saw it also. [ Pause ] It seems that currently there
is no one body that’s linking to guidelines. I don’t know if it’s
appropriate for us to make this a major
recommendation at this point and I personally have
my own bias against… I much prefer the idea
that medical societies, professional societies who make
these guidelines foster them and defend them. That they be the
source for guidelines and that you don’t put
the federal government in the position of
vetting or voting for one guideline over another. I agree with that, but
I think also people go to the federal government to
find out where information is. So if there are multiple sources
of peer-reviewed guidelines, the federal government could
point to all the sources. What we cannot do is
pick winners and losers. So you wouldn’t want to just
pick one and link to that. But I think it would
be an opportunity lost with all the people who
go to CDC and NIH sites for information and
then you could link to the multiple societies that
offer some recommendations. Well, why not put this
as a possible tabling for year two rather than now? Sounds like a great
parking lot exercise. What if you took the Metro? If we’re going to park that. I’m sorry. Are you saying… Are we tabling the
language that says, “Refer to the NIH website?”
Is that what you’re getting at? Any language around referring
to one place for guidelines since there apparently is not a
single national place for them. It doesn’t mean that
can’t be revisited. Well, can’t we just be honest
and say there are two sets of guidelines up that people
always see and conflicts? Can we say there’s
two guidelines up that people always look at? Well, maybe there
will be more than two. I mean the other thing about
guidelines is they’re… To my knowledge, the
IDSA is now combining with several other
medical societies to come out with their updated
guidelines and I’m sure ILADS will probably
be updating their guidelines. There may be other groups for tick-borne diseases
that we’ll be having. So I think this is… I understand where
this is coming from; I just think it’s
not helpful in terms of moving the process
forward at this time. Um, I don’t agree. The politics.
This is not just
a medical disease. This is a political one and
that definition has been used against patients for
many, many years. It’s been used against
physicians in medical board
hearings and they need to do right by the patients. They need to do right
by the doctors. You’ve got a spreading
epidemic and you’re not going to find doctors out there
who want to treat this because they’re afraid their
medical licenses are going to be pulled and the
insurance companies going
to drop them from panels. The government has to do
something at this point to make it right and to say,
“Either there are two sets of guidelines or the
surveillance criteria is not for a clinical diagnosis,” . But you’ve got to set the record straight because you can do all
you want in this committee to fix diagnostics,
to fix treatment, but if you can’t find providers
out there who are willing to treat patients
because they’re scared and they don’t want
to lose their licenses and it’s affecting by the
way European countries too. I have a lot of patients
from Europe that the French and the Belgian, and other
governments are following the CDC, because the CDC is
the worldwide reference, essentially, and because
it’s not on there, these patients are suffering
in other countries also. So what if we try to
do a hybrid approach and the action would be,
“We’ll create a federal website with comprehensive resources
or balanced resources” and then the parking lot is
what that content would say, whether it’s disclaimer
between surveillance and the clinical diagnosis
whether its multiple links to all the peer reviewed
guidelines. One thing government can do
is say, “Here are the criteria that you need to meet or
that member, organizations, societies need to meet in
order to be linked to,” and then anyone who meets
those criteria, you know, would rise above
the line and all. So could we agree that there
will be one federal website or repository where
the full suite of information could go based on
some criteria to be determined in the future, like with that? I need a question
answered before I can get to that place, from Dennis. Um, Dennis, what is the current
NIH policy with other diseases in putting up treatment
guidelines or surveillance criteria
or whatever? I don’t know the whole
NIH criteria list. I can give you personal
experience in years with the mycology program in running the clinical
trials for Mycosis. We refrained from involvement
in guidelines and allow that to the societies
to develop. It may be different across
different parts of the NIH. I would be agnostic
as to where it goes. I like the idea of the
generality of a single site for
information to be available and it would be the appropriate
one, whatever that is. Well, I guess I’m not sure
that that answered my question. So the answer to your
question is I don’t know. Okay. Well, here’s why
I’m asking the question. I’m asking the question because
physicians generally think that the NIH is the
end-all and be-all when it comes to treatment. That’s where they’re going to
go and even though I certainly like the idea of this type
of website I’m not sure that clinicians know
to go there. I think that even with
the National Guidelines Clearinghouse and that
recently had, you know, criteria that were approved
by, I believe, the Institutes of Medicine approved criteria in
order to get those guidelines on and so on and so forth and it
became a little more visible because patients and
advocates made it visible, but I wonder whether if indeed
the NIH has treatment guidelines all over the place, let’s say,
and that’s the general gist of diseases, that you
do have them there – then why would we want to make
Lyme disease any different than that? Because that’s been the problem. It’s always been
treated differently and in a different manner. And so I would want
to find out whether… you know, what the
policy is on that and you know how that’s handled
to see if indeed we would like to say, NIH or create
something like this or both. So let’s do that as an action
item and get more information
on how other diseases are handled and I don’t think they’re
necessarily mutually exclusive. What I heard Rob and Dennis say, in that such a federal
website could point to the difference societies
that have guidelines, maybe not directly
pointed to the guidelines,
but to those societies. So I think that we may be
splitting hairs here and kind of be saying the same things
talking past each other. But I would say, let’s get more
information on other diseases and then put some of the
details in a parking lot. I think the only problem
is the timing here in that AAHRQ is going to
go away and so what happens
in the meantime when… I mean, and patients do… It’s a lot to expect
patients to get to IDSA or wherever this new
kind of hybrid guidelines from
them and also to ILADS. So that was one place where people could
go including doctors. It would be, I think, too much
to expect to have them go three
or four different places to get the same information
they can get on one website. So the question is, can we
do something in the meantime? Is there a place to put it in the meantime before
this report gets written and acted on upon? I’ll standby I don’t know, but
there are two other agencies like HRSA and SAMHSA
where these might fit too. But I don’t know that
that’s the answer. So I think the action
is clearly an action. What is the policy and where
would be the best place? We can’t get an answer
on this prior to this report being produced? I mean I’m sure Dennis can go
back and get an answer, right? I would suspect so. I would suspect we could get
the information back in time for the final printing. Right. Exactly. Well, I’m thinking that we
have the meeting tomorrow. We have another meeting
and, you know, if he can get the information
back then we would kind of maybe know which
direction to go with this and if everyone agrees that we
would use either one or both or whatever, then we could
move forward with that. So we don’t have… So just so I understand, we don’t have a definitive answer whether treatment guidelines for Lyme and other
tick-borne diseases exist anywhere on any federal
agency website, right?
Or do we know that for sure? They’re on the National
Guidelines Clearinghouse right now. Right. Yeah. We don’t know where
else they might be. For the next six
weeks, basically. Okay. So that’s it. Okay. In terms of the new
guidelines coming out from IDSA, do we know if they reference
the CDC two-tiered testing in their guidelines? Because you know I’m looking
at the old guidelines now. Unfortunately, you know,
it does say under diagnosis of EM section, “Using two-tiered
testing algorithm recommended by the Centers for
Disease Control and Prevention” in
their guidelines. Yeah, so… No, we’ve had absolutely
no involvement with those guidelines
development. We’ve not seen them,
but, you know, again, the thing about two-tiered
testing, again, it always comes back to
CDC, but it was a PHL. It was CSTE. It was CDC, FDA, NIH, you know
a whole federal conglomerate that made those recommendations. That’s why I point that out. You may be being
misquoted in the guidelines, because it’s just laying it
all on you in the guidelines. Right. So we did ask them, that
new guideline consortium to come to present to our group
and they declined. They did point out there
was some publicly available information on what they’re
doing, but they would not come to present on their progress. So with the National
Clearinghouse coming down soon, can we hold both the IDSA
and the ILADS standards up into a link from HHS for now? Let’s add that to an action
item to get more information and I can be point on that and
figure out what’s possible. I can say the next six weeks is
lightning pace for government, but also recognize that
this is really important for the community. So I’ll take that as an action item. Thank you.
I’m drafting my email right now.
I appreciate that, Dennis. [ Pause ] So are we ready to vote on… We have… I guess in the first
recommendation one we just have that single action? Is that right? Yeah. “The federal
repository for information on Lyme disease treatment
guidelines.” alright. So one action. “Create a federal
repository for information on Lyme disease treatment
guidelines,” with you having a
follow-up action below it. Any… Are we ready
for a motion on that to create a federal
repository for information on Lyme disease treatment
guidelines and for Kristen to follow up to see if the link
can be made from the HHS site? I think we need to
maybe add some language around making sure
stakeholders… all stakeholders are included
in that discussion and as to the content that’s
being included, as opposed to just letting the
federal government decide what goes on there. On what… the first action
you’re talking about? Uh huh. So how would
you reword it? [ Pause ] That includes diverse
perspectives from different stakeholders
or including stakeholders in the development and
creation of the website. I think we’ll have
a trade-off here between diverse stakeholders and how quickly we
can get things up. So if we want to quickly just
post all the peer-reviewed guidelines and some basic
qualifiers; for example, distinguishing the
surveillance criteria versus diagnostic criteria,
that is a quick near-term action and then the longer-term
one, in my opinion, would be the diverse
stakeholders and perspectives… I think that’s fine, but
tiering it, so to speak. So yeah, we’re going
to keep the… that action one, then potential. We’ll keep that in about
referring to the distinction between surveillance
and diagnostics, right? That’s going to be part of it? Okay. And then would we
delete “potential action two?” Or maybe we make them
more general, like post… Instead of ILADS, “I would say
post peer-reviewed guidelines that meet certain criteria
on a federal website,” which I think we already
captured with the action item. So I think we can delete
that potential action two. Yeah. Universal peer-reviewed
guidelines? Yeah. I think you do
capture it with… I think we did. So we can just delete
potential action two. What about grade? They use grade – G-R-A-D-E
– to assess guidelines. Uh huh. Is there a way
to use that as a, uh, something to put
in there for that? I just want to follow
up on that. I think that that’s one of the
number of different evidence, you know, systems for
vetting the level of evidence to the quality of evidence.
So it’s a little different. A guideline will incorporate
grade or maybe nice or one of the other in looking
at the evidence and grade it using that, but that’s really
a different process than a guideline
and so I think… Again, I wouldn’t
pick a particular… I’m not an expert in this,
but a particular method out of the blue without really
looking at what are the… Maybe you want three methods
or you maybe want two. So that’s… Well, is it like CME credits? Is there an accrediting
agency that does these systems of evaluation or you know? I don’t know the answer to that. I mean, guidelines are
generally, as I said, usually come out – the
ones I’m most familiar with come out of the IDSA. They have maybe 20 different
guidelines on all sorts of diseases and they’re
put together by infectious disease experts
and other experts who come in to advise them on the
areas they don’t know. They look for consensus. They grade the quality of the
evidence for the clinician. They say whether
it’s expert opinion or where there are good
trials to substantiate this and they put it out
there for you. So that’s the process. Beyond something that
comes out of that world, which I know a little
bit about, I don’t know. I’m sure there are all kinds
of variations on that theme. Maybe Dennis can… But grade I think is
emerging as the standard. It’s just from our discussions,
we discussed a little bit in our report and there are lots of American healthcare
organizations, ASIP. I think part of the
IDSA guidelines for Neuroborreliosis
used grade – ACP, AAFP. So I think it’s emerging
as a standard. So I think it’s a, you
know, it’s a good point that could be something
included since it does seem to be
emerging as a standard. [ Pause ] So we’re trying to
consolidate your action up there and help us kind of
do the final polishing of what we should
propose a motion on. Okay. So my concern is that… I mean I agree that I think
grade is one of several systems that have been used to
validate the evidence to support the data
for recommendation. I’m not convinced
it’s the only one. I wonder rather than name… mentioning one particular
system, we should just say, “That has been adequately
validated using the standardized accepted validation system.” Something more like that. I think that’s a great way to
frame it and definitely the role of government more,
a separate criteria and whoever meets
those criteria, um, you know qualifies, but
I think that that’s… Like we have to get out
of the weeds and focus on just the top level things. So we can include that as a
sub-bullet and then polish it and
finesse it down the road. We are behind schedule though,
so John and I are going to try to bring people up to the
action and Coop and Bob… Yeah, we agree. Okay. Does that top level action
capture what you want to say? And then the sub-bullets we
can flesh out and refine later. Okay. Yeah. It we’ll keep with that and
revert back to the 2011 language as a sub-bullet, yeah. I think that… Are you okay? Yeah. We just want
to keep, you know, we would link that to an HH… You’re going to check and
we can see if we can link it to an HHS direct for now before
the guidelines come down. Okay. Yeah. So we’re going to vote on that
top, the action, that first. The only question I
have about that is, do we want to leave this
only for Lyme or do you want
to say Lyme disease… No. … and other
tick-borne illnesses? Lyme disease and
tick-borne illnesses. Borne diseases. Disease. I’m sorry. Thank you. Yeah. So I make a motion
that a recommendation will be “Create a federal repository
or webpage of information on Lyme disease and
other tick-borne disease treatment guidelines.” Or we could even get rid of
the “treatment guidelines,” because we could
keep it general. Agreed. Could you
amend that motion to include using the sub-bullets
again as verbiage surrounding that after we clarify
the issues we discussed? Yep. So other tick-borne
diseases to encompass and then colon and
those three bullets. If we do that, then I would under potential action
three delete IDSA, just because all guidelines
should have those caveats… Yes. … not just IDSA. Exactly. [ Pause ] Delete the whole thing? No, just delete IDSA. Just keep a footnote
on the guidelines. So the action would be “To
create a federal repository for information on Lyme disease
and other tick-borne diseases to encompass, um, this is
peer-reviewed treatment guidelines that rise above
some criteria to be determined that revert back to 2011
language on the CDC website that distinguishes between
surveillance criteria and diagnostic criteria and also
draws attention to a footnote that these are guidelines,
not immutable rules.” That was a motion. That’s a second, here. Further discussion? I think we just need the
language to catch up to the… what we’re voting on. I still have a question. I defer to Ben a little bit
about the telling the CDC what to put on the website which is
not currently on the website. This is not for the CDC. This is for a federal
website somewhere. Well, maybe I misunderstood
the bullet there where it says,
“Revert back to the language… ” So that’s just a bullet
that’s for discussion or is that coming off? There’s actual language that CDC
used to have on its website… I know. …
between 2011 and 2017. So we’re hoping to
pull up something like that as an example.
It doesn’t have to be verbatim. And to be placed where? Can… Oh, I’m sorry. On this federal clearinghouse
of information for tick-borne diseases. Not on the CDC website? Right. Wherever it ends
up, to be determined, that will be my action item. I just wanted to add to that
that the recommendations that our committee, Ben
and I made this morning, we have a recommendation
in there that would address that issue that says that the
CDC and other agencies need to acknowledge the fact
that these criteria are for surveillance purposes
and not diagnosis. They need to put it in MMWR and
it does say on the CDC website and other, you know, other ways. So we kind of already
have that memorialized. So, yeah, but if
it’s captured there than I think we can remove it
from here just to make it… Is that what I’m hearing? I would keep it in here as
one central clearinghouse for federal site with everything
and then if the CDC wants to crib that language and
update its site as well, great. Okay. But that would
be my recommendation. So we have short-term
and long-term only. Okay. Are we ready for a vote? Wait. We’re looking at
some additional language. Do you want to read them
again one more time? Sure. Alright. So we’ve got… The action is “Create a federal
repository for information on Lyme diseases and
other tick-borne diseases to encompass… to be sure that the federal… ” This is the parking lot issue. “… the federal
website has links to peer-reviewed
treatment guidelines. Revert back to 2011
language on the CDC website,” but it will be contained
here as well as what’s recommended
for the CDC website. “Distinguishing surveillance
criteria versus diagnostic criteria and
then draw attention to footnote on this newly created
website that guidelines… they are guidelines
only and not strict treatment recommendations.” I would call that last
one “treatment rules.” Yeah or standards of care or… Yeah, whatever the… I like that. [ Pause ] So are we taking off,
“to encompass” on top? What is that doing? Um, I think we’re leaving
“to encompass” to allow for flexibility, because
the sub-bullets are kind of placeholders that
we’ll finesse later… Okay. … but… So it could be “to
encompass” colon. Colon. Yeah. [ Pause ] And then just take the plural
off “disease, Lyme diseases.” It should be “Lyme disease.” One thing before we vote,
when you go on the CDC website and you look up post-treatment
Lyme disease syndrome, it links up to “Studies funded
by the National Institutes of Health have not
shown that people who receive prolonged courses
of antibiotics do better in the long run than
placebo; furthermore, long-term antibiotic or alternative treatments
have been associated with serious complications.” The problem is it’s
kind of a loop on there and that is implying that no
one who has chronic Lyme, PTLDS, whatever, is going to get
better with antibiotics. So the way we’re creating
this now with the wording with the federal repository,
my concern is even with some of the language that’s
on the CDC website, it kind of goes towards
IDSA guidelines even if it doesn’t particularly
express that it’s coming from there. Yeah, noted. I don’t think that this
motion though is necessarily CDC website. In fact, I think it would
probably be something different and then the CDC changing that would probably be
a different action item. Okay. Just to be clear, we’re
voting just on the bolded part? Correct. And the
other part is… Placeholder… … to be discussed? Exactly. To be discussed. Details to come, but we’ll at
least consider all those points. Last comments? Do we have a motion? We have a motion up there. Okay. Let’s take
a roll call vote. Uh, Bob Sabatino. Yes. Scott Cooper. Yes. Ben Beard. Yes. Wendy Adams. Yes. Rob Smith. No. Pat Smith. Yes. David Lieby. Yes. Allen Richards. Yes. Richard Horowitz. Yes. Dennis Dixon. Yes. Kristen Honey. Yes. John Aucott. Yes. So one negative
and the rest yea. Motion passes. So we’re running
a little late now. It’s been worth it
to get things going. We’re still not really through
with access to care, right? So it’s 4:20. We should be in the
middle of a break actually. So does the group want to
push through access to care or take a break and come back? Push through. Push through? Push right through it. I think that was our hardest… Is that the hardest? I think so. Alright. I don’t see
any violent objections. Okay. Yes, alright. We’re going to push through. Alright. Agreed. [ Murmuring ] So, the second one
is about funding. So it’s “to establish the
funding from the center of excellence that
already exists to serve patients facing health and public health challenges
ranging from autism to cancer, to minority health disparities.” And then the second into that is
“To allocate increased funding for tick-borne disease in the
area of research treatment, prevention proportional to
cancer and HIV and AIDS.” Um, so the way I see this, the potential action seven
could be the bold thing that we all agree on and then
we could cut-and-paste potential action five as a sub-item –
because I think the centers of excellence is a great
starting point and one example, but not the only one of
things that we could use for tick-borne illness
and scale. The other one that I know
has been mentioned is PEPFAR for AIDS/HIV. So I think there are
other examples as well. We agree. Right. [ Pause ] So it’s a single
recommendation at this part? Yes. Right. Okay. Discussion about
increasing funding for tick-borne disease research
treatment and prevention? You put up “proportional
to cancer… ” I’m sorry I just
mean, HIV/AIDS. I mean, can you explain? There’s very… If you look at the funding
that goes into HIV/AIDS and you compare that to
cancer to Lyme disease and tick-borne disease,
they’re so far off. There’s so much more money
put into those diseases rather than ours, so we’re just
looking for something of equal value or
investment to it. I guess I just… The word “proportional,” I
wasn’t sure how to interpret, because that could be mortality. It could be, you know,
burden of illness. There’s lots of different… and how that’s read might
change the decision. So maybe one recommenda… I’m worried that it might
work against you, too, because if you’re looking at cancer gets how much
money for what reason? And if you look at the
criteria you may… If you want it to
be proportional to the criteria used for HIV
and cancer, it may be smaller than you’d like it to be. Yeah. So maybe one thing we do
there is just take “proportional to cancer HIV/AIDS” and
make it a sub-bullet for further discussion
and we can finesse it and refine it in the future. I would leave it off. Yeah. I’m kind of… I would think “proportional to the need” might be what
you’re trying to get at. Yeah. It’s… Yeah and to the… Burden of illness. What about, “proportionate
to the burden of illness.” Burden of illness and the number
of cases and the number of cases
as it increases each year. [ Pause ] Yeah, “proportional to the
need and burden of illness.” Uh huh. Yeah, we’re
comfortable with that. Yeah, and I would go away
from specific diseases. You’re essentially
setting up a competition with some other diseases. I agree. I think
that’s a good point. [ Pause ] Yeah, we’ll take out the… about the “proportional
to cancer, HIV/AIDS.” Thank you. Uh huh. [ Pause ] Other comments? One other comment. With the centers of excellence, I had mentioned there are
different models and bullets. One other area could be
patient registries that came up in several of
the subcommittees or patient powered research
or patient engagement. I’m just trying to get at
beyond the academic centers of excellence or the government
centers of excellence. How do we capture the
patients in there? I would like to keep
“patient powered research.” And again, I think this is
part of the parking lot, but we can discuss it. I just want to make sure we
capture that patient part of it. And the center of excellence, these are treatment
centers, research, both? I think we were envisioning,
yeah, research and treatment with that, but I know
that Ben, you just gave out there some regional centers
of excellence that CDC… Is that surveillance
and prevention? Those are specifically
vector-borne disease really public health entomologies. So they’re not clinical
at all which is kind of the question I have. I mean going back to this theme
to what Richard’s talked about. I wonder if what is going to get to this more would be
clinical centers of excellence. It really focused on chronic
illness to include, you know, Lyme disease related illnesses,
because what I see in medicine and maybe it’s particularly because of the way
we’re organized at CDC, you know we’re very
much pipelined. “Well, we work with this,
but we don’t work with that and someone else
works with this.” And what you’re talking about is
a multi-disease sort of problem and having people who can
deal with all aspects of that and not just with
the single pathogens, single cause type theme. So I think that’s an interesting
and good idea, but I wonder if the focus rather
than putting it on Lyme and tick-borne diseases it would
be more effective and more clear so it’s not confused with these
vector-borne disease centers of excellence. So really more basic biology
and public health entomology. But it’s just something
to consider. Yeah, that’s why I… I had the feeling that
that’s what it was. It wasn’t clinical. So yeah, I think it would…
I think, yeah, to… How do you feel about broadening
that out to, chronic… Or chronic illness? Yeah. It makes me think
of Dennis’ “feels, functions, and survives,” again. [ Pause ] Yeah, if we could
put that on there. I mean we’re looking, like
you said, voting on the bold. Right. Do you want “chronic”
in there, because that by its nature excludes
then “centers of excellence for acute tick-borne diseases.” Or mean it doesn’t imply that
you’re going to include them. Well, I was assuming that
“acute” was part of the centers of excellence in the bullet
above it and then elaborating on that was the chronic
illnesses and more complex ones that might go beyond tick-borne
diseases in a more holistic way. We could say acute and chronic. Yep, there we go. Acute and chronic. I like it. Agreed. Should we say, “And
other tick-borne disease” as opposed to related illnesses? Yes. I think also, you know, we
had talked about clinical trial, you know, if you’re
doing clinical trials, you might need a clinical
trial network like they have in oncology and AIDS that
are already set to go and so this is someplace you
could fold in that as well. [ Pause ] Ready for a motion? I make a motion to approve. I second. Alright. Further discussion? alright. We’ll take a vote on… This is just on the
bolded material. Vote: Bob Sabatino. Yes. Scott Cooper. Yes. Ben Beard. Yes. Wendy Adams. Yes. Rob Smith. Yes. Pat Smith. Yes. David Lieby. Yes. Allen Richards. Yes. Richard Horowitz. Yes. Dennis Dixon. Yes. Kristen Honey. Yes. John Aucott. Yes. So unanimously passed. Alright. Next topic. The last one is “The
discrimination for jobs and for students of all ages by
Lyme and tick-borne diseases.” I’m just going to move it
down so it’s all together. [ Pause ] Okay. Which we went
into earlier. How does this differ from
American with Disabilities Act or does it fall under it? Yeah and I think
that’s the question, you know whether it’s covered
or even on the radar for it and so this may be more
of an enforcement issue, an investigation enforcement,
the same way with the Department of Education and what’s
available there whether… I mean it probably would be, but whether it’s being
investigated and enforced. So I think it’s maybe
calling attention more to it, but that’s something I
think we’d have to look into a little bit more to
see if the mechanism is in place under those, so. I have a question. So are we saying then that
only the bolded portion of this is going to
be the recommendation? Because I would like, quite
frankly, the school area to be a separate one,
a separate entity. I realize it falls
under discrimination, but I think it’s an issue
that isn’t often looked at and addressed and I think it
needs that force of direction as opposed to being in the
verbiage surrounding that. Okay. Can we separate them then? So potential action eight and potential action nine would
each be their own high level bold sections? Yes, one for employment and
the other one for students. Can they just be combined
into one bullet point? That’s what Pat was saying about
bringing out the “schools” part and you know I’m wondering, too bad that that
part of it may need… what exists under the Department
of Education and the language that you would come up
with, whether that’s going to need more finessing from
the government to enforce it and maybe under ADA it
wouldn’t need as much. So I’m saying that maybe “needing more attention,”
than the “jobs.” But I wouldn’t want to lose
either one them and if you’re… We’re already over our two. So this is going to give us four
potential or recommendations. So, if everybody’s
okay with that and if we could separate
those as recommendations. I think separate them
makes sense in the lens of who our audience is, because
the Disabilities Act could be very different from the
Department of Education. Right. [ Pause ] Alright. So let’s entertain
a motion for “Protection from job discrimination due to
Lyme and tick-borne diseases.” So moved. Second? Second. Alright. Further discussion on that? alright. I think this is going to be an all in favor
say, “Aye.” Aye. Opposed. Abstentions. Alright. Let’s move
on to the next one. “Protection for students of all
ages from discrimination due to Lyme disease and
tick-borne diseases.” Entertain a motion for that? So moved. Second. Second. Any discussion on this? Alright. I’m going to do
an all in favor say, “Aye.” Aye. Opposed. Abstentions. Excellent. Alright. Does that
finish your… Yes, it does. Thank you very much. It does. Thank you. Okay. It’s 4:33. Um, are the dinners here? They’re coming at 5:15. Okay. So we’re going to
take a break for 10 minutes and then come back and
collect your dinner and then we’ll start a
working dinner meeting. Thank you. [ Break ] We did also think that a
couple of lessons learned from the prior deduction could
include, uh, including children in the development testing
of a vaccine since there one of the highest risk
groups for Lyme disease and then before introduction
a process involved bringing in patients, providers, payers,
uh, all of the people you see in that list to be a
part of the process. Next slide. So that’s our vaccine action. For our therapeutics we really
focused on therapeutics for – [ Audio Issues ] and that’s it. [ Pause ] Let’s take them one at a time. Uh huh. If you can go to
the first action please. Prior recommendation. Can we have that
full screen again? [ Murmuring ] While he’s doing that I
just want to make a sub-note because we did talk about
reservoir targeted vaccines in our discussion and felt that
that was a valuable research that needed to continue,
but put it more into the prevention piece of
this rather than this piece. So I just wanted
to mention that. Alright. Let’s open it up for
discussion, human vaccines to prevent Lyme disease. So I was wondering about the
other tick-borne diseases, obviously, because
so many are in there and I know it was discussed
in your report about from – Utpal Pal and from
other researchers, using – the tick vaccine, so any sense just because there
is Powassan and all these others that does it make sense to have a vaccine that would
prevent all transmission of tick-borne diseases? Sure and I mean I think there is an opportunity, at
least with I Scapularis, I Pacificus if you
had an effective, let’s say a SALL
array protein-based or multiple proteins-based
vaccine, theoretically that might
prevent more infections than just Lyme disease. You might prevent… I don’t know about TBE because it’s such a rapid
transmission time that the – vaccine might not
be able to do that. We don’t know how much
of a problem it is, but yes, we did consider that. We also looked at the fact that
we might be looking at a kind of two-tiered approach
that if we wait for… And there’s a lot of really
robust excellent science going on in that area with Dr. Pal who
presented to us and things… works come out of Dr. Fikret’s
lab and Jorge Benach and others. So that’s an excellent
area of research. There’s real potential there,
but looking at where things are at this point it looked
like a longer range project. So we actually thought
that it was… We would make a recommendation to consider a two-tiered approach. I didn’t make that in bold,
but that was our discussion with a shorter range
being vaccines that are on the horizon supporting them, seeing how – how they perform and at the same time
continuing research for vaccines that might
offer the possibility of interrupting transmission
of other pathogens. Okay. So here’s the situation. And I started discussing
this a bit on the phone call and my concern with
a recommendation like that is first of all,
there is a vaccine already in the approval process. I think they just finished
phase 1, I believe and are into phase 2 and I believe that they have fast-tracked
the vaccine and this is of a grave concern to many,
many people and I can tell you that since the phone
call meeting people that have been active
in Lyme for many years and knew individuals on the scene are highly
concerned about this issue. So I tried to come
up with something that I felt would be
perhaps a better first step. I don’t want to say that
we want to – to me anyway – to recommend a vaccine
when I’m not sure that we have the
answers to what happened. So this is what I… And again, it’s a little long, but I’m just throwing
it out there. “Congress directs the FDA to
prepare a comprehensive report when the OspA-based vaccine
LYMErix presenting all the science then and now
related to the mechanism of that vaccine platform and how
those findings can affect any other OspA-based vaccine
undergoing the approval process now or in the future to
ensure problems related to the LYMErix vaccine
are understood and corrected before any
similar vaccine is released to the public.” So Pat, I presume your concerns
are safety as well as efficacy and the company Valneva has
published a press release with a phase 1 clinical
trial involving subjects in the United States
and Europe conducted under investigational…
Well, conducted under regulatory application that showed no significant
adverse event. So there’s the adverse event. You’re not going to go
efficacy out of the phase I. So moving forward I
think we were fortunate to have at least one company. We didn’t pick a company. We’re just saying that we think
it’s hard to argue with wanting to move forward with
a human vaccine that has the potential
to eliminate up to 80% per the
efficacy published in the previous vaccine
of the 300,000 cases that are projected
to occur every year. So if you have the potential
to eliminate 240,000 infections with a safe and effective
vaccine, why wouldn’t you do that? And so our recommendation
is we should continue in that direction and that I
think there’s no reason why other analyses couldn’t be done. I think several were
already done. The FDA held in 2003 another
advisory committee report to look at the post-marketing
adverse events and came to the collusion that there
was no significant association of adverse events with vaccination. That could be done in some
other way and I would hate to see momentum slowed
down for something done under regulatory authority
that demands safety be proven with oversight for
subjects in the trial through a safety
monitoring board. That’s why we came to
this recommendation. Well, Dennis, I hear
what you’re saying, but unfortunately I
lived in that time. I advocated in that time. I had to support patients and
their families in that time and I have to say to
you, you can tell me that this vaccine is safe
and why wouldn’t we want it? It’s not a matter of
people not wanting it. It’s a matter of trust and
trust was not only violated, it was violated in my opinion,
pretty viciously and so we need to ensure for the population of this country,
to be quite frank, not just the existing
patients, but we all know that everybody can get re-bitten
and get Lyme disease again and so on and I don’t think
there was transparency. I don’t think that the
issues of, you know, people having conflicts of
interest over the whole process, and I have not seen a
report come out of Valneva who wants this vaccine.
I would like to see it produced.
I want to see a full report and I think the government
should do it; a full report showing everything
including all of the references to the science, because quite frankly there weren’t
hardly any references to the science in the report that you gave backing
that recommendation. Well there was a lot of
references out there based upon that vaccine and there’s a lot of very knowledgeable
researchers who have produced those
papers and peer review even at that time and
since that time. So why can’t we convene,
you know, some kind of a meeting
or whatever it takes of researchers to sit down and put something together
showing us what really were the problems, not only the
scientific problems, but quite frankly the failure of
the VAERS Adverse Event System? Okay. I think… Just let me finish one
more thing, John, on this. And that was not only
shown, but if you look at the FDA slide deck –
and we have a copy of it on our website – the
FDA even indicated at that time the
serious problems with the Adverse
Events Reporting System and that was a huge part of the
problem, because adverse events, unfortunately, were
not being reported and there was a paper done by
Dr. Marx afterwards who was a… is a famous person in the
field of vaccine and looking at those adverse events
that were reported and I think it’s
problematic and I think if you really want a
vaccine, then you have to address the fact that there’s
going to be a lot of resistance. People want to see something. They want to see what really
happened, and I for one – and I was pretty involved
– don’t know what happened. Our recommendation comes in the
context of regulatory oversight and so my understanding is the
role of the FDA is to ensure that new measures coming
forward are adequately and appropriately
safeguarded for safety and that efficacy is
demonstrated in that in a full and transparent fashion. So we’re not saying do this
without regulatory oversight. It’s, “do it within a very, very
stringent process in accordance with all of the other
countermeasures that are available and
in use in saving lives.” Excuse me. Let some other people
talk, please. Okay. Um, so any other
comments or thoughts on this? Do… And I have not read
that trial for a while. How many patients were
included in that phase 1 and do you think one phase 1
is sufficient for something like this where there’s
a history of inconclusive results or
unknown adverse events? Certainly additional
trials are needed. There may be other
candidates that are needed. So again, we’re not endorsing
one particular study, one particular approach,
we’re endorsing the concept of a vaccine effort being
advanced and move forward so that we have this
countermeasure in the same toolkit that
other diseases have in theirs. Yes. I would just
follow up on that. The major trials back in 1998
or before, there were two trials with 10,000 patients
each half-and-half, placebo and vaccines. So a phase I is really
just the phase I. It’s the beginning and then
it would lead to phase 2. Phase 3 trial would be
much larger and you’re not, you know, before then – correct me if I’m wrong – you’re
not anywhere near the point of licensure for a vaccine. Correct. So before… You know, Pat, you’ve kind
of put out a second proposal. So before we go to
your proposal, I think we want to give them… You know we want to focus
on the original proposal, but you’ve got your
proposal out. I mean we’ve tried in the other
reports to mold the proposal so they were acceptable
to everyone. So in that spirit I would like
to see if we could come up with a way to
mold this proposal so we could reach the prior… You know we’ve been pretty
unanimous after we work with these, so is there a
way to work with this, Bob, that removes OspA
vaccines or to modify this? Well, we don’t… You’ll notice our… We just say human vaccine
to prevent Lyme disease and clearly we’re aware
of the history. We made that clear up front
with the past OspA vaccine, but we also didn’t feel
as a subcommittee that… and we didn’t include references
I should point out, because we discussed that. We have many references, but we
did not have time to do a full and complete search and we
felt putting in references without doing a formal
search was not, uh, something we could do later, but we do have references
if you would like regarding the safety of the past
vaccine, but we’re really… The point was not to… Beyond learning what we could
from that episode was to say, “Can we agree now that it’s time
to make this a recommendation of this working group that Lyme
disease is a big enough problem and we have vaccines first
at our doorstep and some that are not so close that
may actually supplant ones that could come along first. We don’t know. So isn’t this time to make this a recommendation a
working group to support in whatever ways we can
and implicit in that is… are the issues that you’ve
raises, Pat, and I don’t… but I think to make… The reason that we left the
recommendation very simple is that’s really the
recommendation. They’re the sub-bullets
which we can talk about, but we really didn’t want to get
very prescriptive at this point. One thought I have that could
maybe bring us a little closer together is that whenever
we mention vaccines, human vaccines explicitly
including safe and effective, because I think so much of
the concerns are around safety and many people are not
anti-vaccine, but they are against ones that aren’t
safe and I know that you, uh, people like, you know, generally
these recommendations came with that implicit assumption, but my one recommendation I have
is every time we are thinking about human vaccines explicitly include safe and effective. Absolutely. I think that’s a
good suggestion. I think the other
thing to remember is that OspA does not hit
miyamotoi and that certainly in California miyamotoi looks
to be as big of a problem, at least in the ticks
in certain places. So… And I know that there
are some chimeratopes that are using both
OspA OspC, but… and I realize that OspA might be
a quicker clinical trial path, because one was approved even
if it was taken off the market, but I think that’s something
that should be addressed or at least thought about, because I think we don’t
know what the burden of miyamotoi disease is and to the extent that we are
giving people a false sense of security that Lyme
equals all, you know, OspA carrying bacteria when
Lyme-like disease might not or doesn’t and we know
that from relapsing fever. So I just wanted… This might be… It’s a point that we need to… that now we know more about,
miyamotoi; miyamotoi being in the United States;
miyamotoi causing infection in the United States and so
we need to keep that in mind that OspA does not
cover that disease. We do have vaccines, not vaccine
and so I think key would be to validate the field and
when you have one vaccine for a disease often
you have competitors. Think what happened with
the shingles vaccine. Which one did you get? You could get both and
so validating the field for a countermeasure that is
effective would be a really good thing – safe and effective. My point is you may not get
the perfect vaccine first. You might get it third or
fourth, but you’ve opened up a pathway for a
powerful, beneficial, cost-effective measure. I think you… If you look at and I’m… This happened a long time ago, so I’m hoping my memory
serves me, but if you look at rotavirus, right, which
was taken off the market because of intussusception that
was not found until late on and you know tens of thousands
of children receiving it. Um, it took a while to get that
second or third on the market, because the taint of
the first one was there. So I think that’s just
instructive and we have to kind of take that into
consideration that just because if the first
one doesn’t do well, it doesn’t mean the second
or third one is going to be commercially
developed just because of that first problem. So in the work plan we
included challenges and barriers and we put first and
foremost, “with the history of the previous vaccine was
a big thing to overcome.” So we recognize that. We recognize moving forward
that we need to provide for assurances and
trust moving forward with the new effort
done the right way. [ Pause ] So from my perspective, and when
we have over 300,000 new cases of Lyme disease each year. We’ve got an expanded
distribution. I’m for any and every safe and
effective prevention modality that we can develop and I… And I mean when I look at
tick control and when I look at integrated pest management
and all the other things that are there, it’s just… We’re just not there
for prevention and I think a vaccine
has great promise. I think to me going back to
something Kristen said earlier, I think, you know, my
sort of hit list of items for a vaccine are:
safe and effective; one that’s been evaluated
in the high risk groups, not just adults but in children;
and then finally, I think it has to address the issue of
transparency and trust that Pat mentioned, because
you know there’s a huge, huge baggage that’s left behind
with the vaccine, with LYMErix and I think all of those things
have to be addressed head-on and so I would like to
see a recommendation for promoting safe
and effective vaccines that have been adequately
evaluated in the high risk
groups and that are done through a transparent
process that, uh, so that no one accuse
someone else of saying, “All the data is not out there.” Because I think this
is really needed. And while I appreciate
the criticism against the one disease
vaccine, I look at that much like HPV vaccines and the
argument about not using it because it gives a false sense
of security because there’s more than just the one key
vaccine that are there. That’s always going
to be an issue and you know we’ll never… I’m always open to new vaccines; the anti-tick salivary gland
vaccine or something like that, but why wouldn’t you develop
the vaccine, at least one, that is going to potentially
prevent hundreds of thousands of cases and the rest of us in educational, you
know, challenge. I’m just saying this
doesn’t prevent you… protect you against every
single thing that a tick bite, but it will prevent
against this and so… I mean personally I’m
very supportive of it and I think it’s a huge issue
– It’s hugely needed right now. [ Pause ] Well, I’ve been quiet
for a while so now I feel free
to say my piece. And my piece is: it’s a
grave concern especially because of the fact that
this new vaccine has been fast-tracked and has the same
platform as the old vaccine. The old vaccine questions
have not – in a lot of people’s opinions
and I’m talking doctors and researchers as well as
patients and advocates – those questions have not been
put to rest, because first of all there is no tacit
admission of the fact that that’s what happened there. There’s really no admission. You see one sentence, it says,
“Well, this is what was thought or perceived or whatever else,”
and then the next sentence, “but it really isn’t the case.” Then in the next
sentence it is, “Well, in this new Valneva
vaccine they have removed that portion of the… ” – now six OspA’s I
believe – and so on that that will change
the nature of this. Well, I don’t know how
and everyone I’ve talked to in the scientific
field that’s familiar with this says the same thing. I don’t know how that
that can really be, you know, indicated that
that is going to happen. We don’t even know exactly
what they did or how they do it and for us to put
up a recommendation, it’s going to appear,
in my opinion, that we’re putting a seal
of approval on that vaccine and the fast tracking of
that vaccine and it’s going to further the discussions
that took place when we tried to get this committee
established which were from the general public
and also from people in the Lyme community that this
committee is only being created so that they can push
the vaccine through. And so I have to say that
even though I would… Would I like to see a vaccine? Yes. Do I think we’re there yet? No. I think we’re not there yet. We haven’t resolved
the questions around the science
of the first OspA. I don’t know how we’re
going to resolve it around six OspA’s now. So as a point of clarification, we’re not recommending
a specific vaccine. The recommendation is for safe
and effective human vaccines without picking a horse and I would bet and
would be willing to bet that we will never resolve to your satisfaction
the old vaccine. It would be unfortunate
for that lack of resolution to prevent a safe and effective
new vaccine for moving forward that would prevent
240,000 new infections of Lyme disease per year. But I also think that
there’s this issue of trust and until we rebuild trust
we may never move forward. So I have a suggestion that maybe we table this
recommendation number one and think about how
to rebuild trust which was a proposal Pat
put forward and I wanted to just put a couple
potential approaches out there, because I do think if we can
build more trust, then the safe and effective vaccine most
people would agree with. But until we have
that trust it’s hard to have that discussion. So Pat, what you were describing
a congressionally mandated report reminded me of a Government Accountability
Office report, like a GAO report of what happened with
the former vaccine. Another approach that could have
a different outcome could be something like a
congressionally mandated truth and reconciliation committee. So rather than being a, “Tell us
what you did and the incentives to give information”
may be misaligned with putting information
out there. The way that I understand truth and reconciliation committees
has been, um, you get people who feel that they have
been harmed by the past to share their experiences
and then those who had an active role in
that to disclose what happened and if they’re fully candid, then you would not be held
civilly or criminally liable. However, if later on as you go
up the chain you find out things that were not disclosed then the
book could be thrown at them. So there are different models of
“how do you uncover the truth?” Congressionally mandating
a GAO report is one way, but I think that that could
backfire and entrench us versus them in the old
history and we would not, from a GAO outcome based on other GAO reports
I’ve been involved in, necessarily build
trust and move forward. So I just want to put out
other creative ways we could approach this. Truth and reconciliation which
South Africa did after apartheid when they easily
could have fallen into civil war is one example. But are there other creative
solutions or approaches to potentially build trust against this very
divided communities? So Kristen is there a way
to build that building trust into the path forward
to the goal without eliminating the goal. Because I feel like tabling
the recommendation eliminates a viable goal that’s consistent
with the vision statement and the mission statement. I completely agree. I was thinking that’s why if we pull this building trust
action before the vaccine for safe and effective vaccine,
they could build on one another. Yes. Does that make sense? It still doesn’t
completely address removing a recommendation that could be… that could have trust as a
part of the way you get there. I guess I was thinking of them as two different
recommendations. So we would not be necessarily
getting rid of a safe and effective human vaccine, but adding in this
extra recommendation for somehow building trust. Yeah, that sounds
different and better. [ Pause ] I think we also need to look at
the wording there which said, “top priority” and where
vaccine development falls in the spectrum of what
should be prioritized for the government and I
realize that it’s, you know, an ounce of prevention
is worth a pound of cure. I understand that, however, for this particular
disease population and patient population we
have been underspending and not looking at good
treatments and diagnostics and so I think the question is,
“How much of the government’s, you know, thought process,
time, money, resources can go to a vaccine when
the diagnostics and treatments aren’t well
enough defined and broad enough to treat the patient
population?” So I think we have to think
about it as a prioritization as well and not just
binary, “we want a vaccine.” Right, but one other
caveat there is that a lot of the vaccine development may
not be funded by government. A lot of it is privately funded,
but those industry incentives and market incentives, um,
this report could help frame. So it could encourage
investment. I still think it takes a
lot of government input, especially for something
like Lyme disease. So I would… Some might be taken; however, a lot of the early
work might be done by private foundations
than government. So, Wendy,So I understand your
point about the relative ranking and where it fits in priority. This was our top priority within
our subcommittee and yet I want to pick up on one thing you said
about focusing on better drugs and better diagnostics. We at least have
drugs and diagnostics and we have no vaccines. So to me that elevates
its relative priority when you’re thinking
of public health and with public health
with vacc… with diagnosis prevention and
treatment and you have nothing in terms of the prevention
in terms of vaccine; it seems like that should count
toward elevating the priority overall relative to the
total list of priorities. Yeah and I’d follow up on
your statement there, Dennis, just to say that this is –
and Ben’s statement – that… And I’ve been involved in some
of the work on field protection against ticks and know how
frustrating this has been. It’s something to get to
work at the backyard level. And we’re 25 years into that
and you’ve seen the numbers of what’s happened with cases. The other strong arm
of prevention is… and other infectious
diseases is a vaccine. We’re saying a safe and
effective vaccine which implies, certainly with what we’ve
just have been talking about. Nothing’s going to
come out of the process until it has been adequately
vetted and we’re seeing that. I have patients… We talked about patients who
were harmed by the vaccine. I have many patients come to
me and say, “I can get a… My dog can get a vaccine. What’s going on? Why can’t we have a
Lyme vaccine for me?” I know of veterinarians
– I won’t name names – who give themselves
the dog vaccine. So I think that this is… It’s not one part of the public that is invested
in this question. I would submit that there is
a large part of the public that really would love to see
a safe effective Lyme vaccine. I certainly agree that there’s
a percentage of the public that would, but I also agree
that there’s a huge percentage of the public that
don’t have an idea about what happened last time
around and so I’d like… Kristen, though I like your
idea of building the trust, I don’t think you can build
trust and make that kind of a recommendation
at the same time. I think that it’s
beyond that and I just… I’m telling you that as I
sit here and I don’t want it to be construed that
this is just me. This is not just me. The UN cry that came out since
Thursday’s report has been pretty amazing and I know I
suggested everyone write in – and I hope that they
did – to people, because I felt through the… you know, to HHS to give their
opinions when they contacted me, because I said, “people have
to know how you feel about it.” And again, if this
were just patients or whatever, but it’s not. It’s physicians and
it’s researchers and I’m sorry, but
I just can’t… My conscience wouldn’t
allow me to do this without having something… some resolution. Those issues from OspA have to be much more further
explored and put out there. We need to see it. I want to see it.
I want to see all the literature. I want to see the minority
literature, if you will, if you want to call it that. I want to see that all
put together and I want to see people sit at a table
and defend that literature. I mean there are meetings that
NIH used to hold like that. I don’t know what
they’re called. I think you guys removed them where they had controversies
were addressed at certain kinds of conferences and things. I don’t know if you
still have it. I can’t remember what
they were called. Conflict resolution
conferences or something. I’m not sure you still
have that process, but I mean I really
think this is huge. This is absolutely huge
and if you really want to pave the way then we have to
find some way to get to a place where we can begin anew. So I heard the third
option there which was a conflict resolution
roundtable or something led by the government
along those lines? [ Pause ] Resolution meeting. Okay. So, Pat would you… How would you respond to a safe and effective non-OspA human
vaccine to prevent Lyme disease with all the safeguards
and public involvement and all the safeguards built
into it as a recommendation? Well, that certainly would
be better, but it would have to be again a transparent
process and a… I said with all those
things built into it. The stakeholders
would have to be… I said with all those
things built into it. All the things built into it. … all the stakeholders
brought into play. All the things we talked about
which is putting non-OspA. Just put it out there. Richard, do you have
an opinion on that? I think all the controversy
hems around the hypothesis of molecular mimicry of a
specific portion of OspA that cross-reacted with a human
lymphocyte antigen presentation and so the OspA vaccines
that I’m aware of that are under development now
have removed that epitope. So it would be unfortunate to carte blanche
eliminate a viable path because of the assumption
it’s all OspA when the argument is hinged around a very specific
piece of it. So I’d rather see it
narrowed down to something that was more specific
to mechanism that didn’t eliminate
a viable path forward. Yeah, and I have to second that. I mean I certainly… I agree with Pat as well about
the issue of trying to bring to the surface what went
wrong and what happened, but like Dennis said, I
mean the HLA-DR4A, you know, peptide thing has been very
well studied and addressed and it’s been deleted
from these new constructs and that was really out
of an abundance of caution because that had
already been published that that didn’t even come
into play with that, but… and it was originally
just a hypothesis. So… But I don’t disagree that
there were a lot of people, a lot of complaints about that
vaccine and it would be nice to know more about it and I
think at the end of the day to build that trust and
transparency there needs to be something to go
back and look at that. But I wouldn’t categorically
rule out OspA. I think that would be a mistake. You would be in favor
of some sort of… See I was trying to look
forward and not go back and open a can of worms. Yeah. It’s just that’s the
leading candidate right now. [ Pause ] So as one recommended
action could we say that this report will
recommend some mechanism for building trust and then
leave it placeholders what that might look like? [ Pause ] I think so. It sounds good to me. This is one case, though, where
the devil is in the details. So I think… Yeah, I mean I would rather have
some more detail here and vote on the detail, but we might… It might not be the right people
in the room to decide on that.
So that would be the issue. But having a mechanism by
which parties come together and discuss the consensus
or the, you know, examines past activities
in vaccine development and in vaccine commercialization
and how that might influence or inform future
vaccine development. Say it again and
I’ll capture it. Oh, God. Um, a mechanism
by which stakeholders… All stakeholders. All stakeholders examine
and discuss past vaccine [ Pause ] commercialization… Uh, commercialization
is not the right word. Um, past vaccine activities
and potential adverse events to inform future
vaccine development. In Lyme disease. In Lyme disease. Yeah. Uh huh. And I’m open to hearing
improvements on that. Well, what… Building trust is a nice phrase. Translating that into, you
know, a real change in terms of the feelings about
vaccines is another thing. We know how difficult the
vaccine issues are outside of Lyme disease in the
population and I think that is responsible public
health people and people hearing about tick-borne diseases that we can get a
stronger endorsement than simply build
trust around a vaccine. I really don’t think that that
represents the majority view of people in the
medical community, and with all due respect to
Pat on that, I don’t know if… Yeah, to be clear though
I don’t think this… … if you want to
call these out but… This recommendation
is not in lieu of safe and effective human vaccines. It’s an addition. Um, and the one change
I would make to Wendy’s thing is adding
transparent in there. So transparent mechanism. But I just want to be clear that this recommendation
one is not preventing us from doing a recommendation
two or any of the other ones
that your group… – We support the concept of a human Lyme disease
vaccine and recognize… Provided that there are
appropriate mechanisms which link into this sentence. So I thought that’s where we
were going, “to endorse the need to move forward with
a human vaccine for Lyme disease that’s safe and effective provided
this can be done with a mechanism
including blah, blah, blah to inform the
future development.” Yeah. And that could
be truncated to capture the key
parts of, “Yes, vaccine. Yes, provided it’s done
with proper involvement of stakeholders in assuring that these concerns are
addressed in the path forward.” My reaction to that is
that if we don’t start with the trust we’ll never
have a common conversation. It will be two separate
conversations and that’s some rationale
for not embedding the trust into a safe and effective
vaccine. I agree that the trust and the
transparent process involving all stakeholders ideally
would be part of a safe and effective vaccine, but I
think given the reality now with different communities
and some of the feedback we have gotten that building trust warrants
a transparent mechanism. Looking at the history will
help pave the path forward for the safe and
effective vaccine and I honestly can’t see how
we would get there without it. We might get a great safe
and effective vaccine, but even if it was
perfect many sub-community or many people would
not trust it. So I kind of second Pat’s
thing of pulling it out and making it a separate
mechanism of building trust and yes, it sounds fluffy
and maybe Kum-Ba-Yah, but trust is consistency over
time and we have not had a lot of consistency and time and
history is not on our side – so we have to start somewhere. And if that just means touch points of communicating, letting people say what
happened, you know, on a regular basis, surfacing
this, learning from it, making the science
more transparent, I think that’s real value
added and I would argue that it owns a recommendation
bullet point of its own. It might save time. It might save time. Right? If you call this out. Do it specifically. In the end it’s going
to help you out, because if you can
convince people that you’re building trust,
you’re looking at past issues, you’re calling those out, and
you have reasons to believe that these new vaccines
won’t cause the same problems that were purported to happen
in humans or in the people who got the vaccine, then you
might save time developing and build a better market. Plus increase the number
of people who will take it and therefore having a more
effective vaccine long-term. Are you building this
is as a prerequisite to endorsing moving forward
with the human vaccine? I was not. Just two separate actions. I think as long as it can
be done simultaneously so that one’s contention
on the other. I mean the vaccine approval and delivery process
is a long process. I mean there’s also ACIP
recommendations and all that stuff that come into
play and so I think that… and as far as I understand
FDA fast-track, all that means is they’ll
look at the package, the completed package in a
more compressed time period. I mean the package still
has to be completed and it doesn’t shortcut that and
maybe David will speak to that, but that’s my understanding
of what that means. It doesn’t mean it’s going to… they’re going to cut
corners or anything. Um, I would like to
address something that Rob said a while back
which was that the majority of the medical community
probably would not agree that this was enough or
whatever recommendation wise. I don’t necessarily
disagree with that statement, but I would just like
to remind everybody that that’s exactly why we’re
sitting around this table, because the majority of the
medical community has not agreed with things that needed to
be done to help our patients who for the last 44 years have
been left in limbo often times by themselves and so I don’t
think that that’s a factor to be considered, because… Just because the
medical community feels that way it doesn’t mean that that’s the way everyone
else feels or what has happened to the other portion,
the big stakeholders, the people that got the vaccine
and as far as the fast-tracking and I don’t know this 100%
because it’s been a while, but I had looked it up at one
time and I seem to remember that they actually do compress
some actions that they take. But I would certainly
feel very uncomfortable and really can’t support
trust building and putting that recommendation on the
same plane in this report. I feel that trust is something
which you gain over time and as everyone has pointed out, I think the benefits
would be huge, but doing it this way now
I’m not sure that we’re going to get any kind of
positive benefits. I mean I can’t say that 100%. Just my feeling from
the feedback. So the “this way… ” When we started
out with our slide, the “this way” was bringing
in all of the stakeholders. That was sort of
part of the process that we were recommending in putting forward
this recommendation. So we skipped over that and
went right to the bullet, but that’s all through
our committee and from the very first day
we talked about it we said, “A key part of this is to bring
in the different stakeholders and people who have
concerns about… I’ll make it, just say
concerns about the last vaccine. There are also many people
who looked at the data, the safety data and said
there was no safety issue with that vaccine and that is
actually what’s the predominant medical literature viewpoint
of that at this point. So I’m just saying
that recognizing that we said this will
be part of the process, but the main idea is we think
the science is there now to get to a point where there can be a
safe and effective human vaccine and we don’t know exactly which
form it’s going to take yet. There are a number of interesting initiatives
underway. Some are going to be sooner
and some are going to be later in the process and primarily I
think it would be disappointing if a committee like this can’t
at least agree that a safe and effective vaccine for
disease we’re saying is so important isn’t a priority. I would just say to that, I will
not be guilt tripped into that. I sat at those hearings. I heard those people. I saw young adults who were
crippled from the vaccine and I’m not going
to forget that. I don’t disagree with you
that the science probably is at a place, maybe, maybe
that could produce something, but until we have laid these
issues to rest I could not… I could not support it and I
know that there are many people out there that have the
same feelings as I do and those feelings are
not based just on the air. They’re based on actual facts. There are actually
also literature, peer-reviewed literature that
indicates that and testimonies of some significant
experts in that field that there were problems. Does this vaccine
have the same problem? I don’t know. I tried to get information
on the science behind it. I could not get that, because it
was in the development process. So I can’t say, but
that’s just my position. Pat, have you seen the
reviews by Stanley Plotkin and by Greg Poland in
the peer-reviewed… Speak louder. Have you seen the
reviews by Stanley Plotkin in the New England Journal and
Greg Poland that summarize some of the scientific
literature addressing this and presenting the… Recently or back when… Recently. I could
send it to you. No, I don’t think I have. I’m happy to send them to you. Thank you. I think we need to kind of
decide where we’re going to go. We have a couple of options. One is to just vote and
see how the vote turns out since we can’t seem to
get a compromise declaration. The other would be to table it
and come back to it tomorrow which I think I’m not sure
that that’s an option. There may be other options. What would people like to do? I’d like to hear a vote since
not everybody has spoken. Uh huh. alright. Then I think we should
just go… So what do we have on
the recommendations? The trust building is
recommendation now number one. Recommendation two is a
safe and effective vaccine which you originally proposed. So do you have a preference
which one we vote on first, Dennis, since they’re your… The second should
probably – Yeah, that’s what you started with. It’s the reason you’re
building the trust. That’s right. So I think that was
your original proposal so we should vote on that. So I think we’ve discussed it
and I think we should vote on it and
see where we’re at. Just one other quick thing. Under where it says “including
children,” I would also ask to include children and people
with symptoms of active disease, after tick bites, because
despite the concern there may be problems immunologically
with people who do have persistent
infection. So I would just make sure that the grouping is
included in that sense. Thank you. alright. So let’s read the… We’ll go back and we’ll read it. So we’re going to vote on
recommendation number two which is a safe and
effective human vaccine to prevent Lyme disease. But what is… I mean, what is the action? Is it to develop? Is it to sugge… Is it to promote? Is it… Just, is it
safe and effective? That doesn’t… That’s not a… That’s a good question. Is it to… Well, I think we… I forget the language, but it
was to promote and develop… Develop. Promote development
Promote development. Please use your mic. I can’t remember what… Please use your mic. [ Pause ] Alright. So promote and develop. I think that’s close to
our original language. I can’t… I’ve lost it up there, but… Okay. I think we used
the word support. That’s ambiguity… It has ambiguity in
terms of whether we mean with money or with words. Yeah, I would use support
other than promote, because that might imply
that we’re promoting the ones that are in trial now. Yeah, I agree. Yeah. Okay so here’s
what you originally had. So do you want to
change it back to this? It’s that item right there. So it could say, “Support
safe and effective.” So instead of “promote
and develop,” just say, “support safe and effective.” Okay. And that could
be financial support. It could be research
and development. Yeah. We get to pick. Exactly. Alright. We’re going to vote. So it’s safe and effective… Support safe and
effective human vaccines to prevent Lyme disease, right? Support safe and
effective human vaccines to prevent Lyme disease. And we’re approving or voting
on it separate from truth
and reconciliation, so to speak. Right, because that was
their original recommendation that we couldn’t really broker
a deal on the other two. So we couldn’t compromise. Can we do a conditional
approval? I mean the problem is if you
do one and not the other. I might vote on two
if we have one, right. So that’s the… Hmm. That’s why I was
saying to do it in order. Why don’t we park it till… Oh, we don’t want to park it. Could we do it? Would you be opposed to
doing it in the other order? Um, yes. I think so, but I
think it could be a phrase. I mean rather than two, it
could be linked into one. But I think that the support
the human vaccine is really… Pat, will you share the mic? I’m sorry. Give him the mic. Rob is talking. Will you give him the mic? That’s fine. So I just think that the gist of what we’re saying is
we’re supporting development of a human vaccine and
part of that process, or central to that process, or
however you want to word that, is the development of trust – and I think that can be
part of the same phrase. It actually links them together
rather than separating them as sort of unrelated pieces. So would you propose
moving recommendation one as a sub-bullet under this
to explicitly call it out? Uh, yeah recommendation
one would be a sub-bullet under this here. But we’re not voting
on sub-bullets, right? But so if we cut-and-paste… Sorry? We’re not
voting on sub-bullets. We’re not voting on sub-bullets,
but if we cut-and-paste that whole thing and then make
it a sub-bullet it will be embedded into the
“support a safe and effective human
vaccine to prevent Lyme.” [ Pause ] Other thoughts? It sounds like the dilemma here
is that maybe people don’t want to vote on the second one unless
knowing that they’re going to… If you vote for one, you
have to vote for both. It seems to be what
the pivot is here. So I don’t know. It seems like you
either combine it… If you put it as a sub-bullet
will you also have it as a second recommendation
as well, or? With all the other sub-bullets,
we decreed them as a… with the proviso that these
points are adequately discussed in the text. So I don’t know why we
would single this one out as being different
than any of the others. So I would recommend
singling it out just because I don’t think we can get
to trust without calling it out and I agree with Wendy’s point
that by addressing this head-on and explicitly making its own
recommendation then we might be able to move a safe and effective human
vaccine forward faster with the broader community. So that was the rationale
I had for pulling it out as its own high-level
recommendation, because I think that trust is so important
that it will be an impediment to developing the vaccine. So having a recommendation of
its own for the trust building with transparent
mechanism, all stakeholders, that does not mean it will
hold up the support for a safe and effective vaccine, but it will be its own
top-level line item. That was my rationale. So if you take the
sentence that starts with recommendation number
one and ends with disease, could you add to that… An “an.” … that includes a mechanism
to incorporate into something like that? These points that you wanted to
make as a second recommendation. So includes and you
could just go… So includes and then
you could just go to “transparent mechanism
by which all stakeholders… ” Uh huh. …
down there. And shorten it if there
was a way to shorten it. Yep. At least it
links them together and doesn’t make
it a prerequisite. It’s part of the process. And so then make that transparent
mechanism the top line item so it has equal weight to the
safe and effective vaccine? Uh huh. Yeah. It doesn’t say where it has to
be done, how it has to be done, but that it has to be done. [ Pause ] I assume that we are
using Robert’s rules, which I believe I remember
from the first meeting. So on that note, I’m calling… I’m calling the question
and I would like to move that we do the trust thing
separately and independently and I move that motion. Second. Any discussion
on Pat’s motion? So the motion is to
go straight to your… Correct. In a separate fashion. The trust thing and
vote on the trust issue. Alright. Let’s take a vote. It doesn’t… That doesn’t preclude anything
else, just that that’s… I move that. Shouldn’t we vote on the first
recommendation before moving to something else? Not necessarily, because
you know we want to get on to the question quite frankly and it’s perfectly
legal and so I moved it. So if we would prefer
to do it this way, do we oppose the motion
and we vote on it? Would that be the way we would
handle that procedurally? No. I already… We also have a motion
on the floor. Right. Right. So procedurally from
the Robert’s rules, we take the motion on the
floor and she’s professing that you take option two before
going to the first question. So I think that here is now… It’s become recommendation one, but was formally recommendation
number two and we will vote on this one first based on
the procedures, but then Pat, if I heard you correctly,
you would want to also pull out the trust building
one as a separate one. So it doesn’t mean that
we couldn’t embed this into this motion, but
we would want to call it out as a separate one. Correct. The motion that I made
was to do the trust section as the recommendation and
that it’s done separately. It’s pulled out by itself
and it was seconded by Bob. Great. So let’s put
a pin in that and we’ll finish the first
motion which is this longer one that includes that and then
we can do a second motion with the…
Where… There was no motion. I heard no motion on the floor. Yeah. No, there wasn’t. No. Let her clarify. No. I heard Pat make a motion. That’s the only motion that I…
And it was seconded. I made a motion. Oh, I thought we were
voting on Rob’s motion. I only heard one motion
and it was seconded. So what we’re going to
vote on now is whether to have the question
called as Pat’s proposed. If we vote for that, then
we will have to address… It’s actually calling
that question. I’m saying right now that
we’re going to vote on… That’s my motion. So if you vote yes
to that you’re voting to a separate trust
priority being what we’ve… we’re voting. But we’re not actually
voting on that second trust on that second priority. No, we are. Are we? So we’d have a yes or
a no for that motion and then if we subsequently had a motion
to do our recommendation one, we’d have a yes or a no on that
and each would be freestanding? You didn’t have a
recommendation. You didn’t have a motion. But that’s because we didn’t
get to vote on the trust first. No one made a formal motion… Couldn’t we do that next? … for that. Pardon? Couldn’t we do
that next – make a motion to recommend the
support of a safe and effective human
vaccine for Lyme disease? You didn’t make that
motion, though. We didn’t, but couldn’t I in
the future as the next motion? In the future, sure. You could make that after. And then that could be a
separate and independent action. Absolutely, but I’ve… There’s a motion on the floor
that action needs to be taken. I have no problem with that
being a separate motion, I just don’t want it
to be a prerequisite that eliminates another
opportunity for a separate recommendation. And that wasn’t her motion. And you guys can get the
note taker to record it back, but that wasn’t her motion. So if someone else in the
group makes another motion after this vote is taken, then you guys can
take action on that. Okay. Alright. I think it’s important. Does everyone know what they’re voting on? No. Yeah, I don’t think
we’ve got it down. So I think… If I hear this right
we want to cut and paste the whole
recommendation one down to option three. Just cut… No. No just cut… No, I think that she wants… … and then copy it and then
we’re going to start over, because there’s two separate
motions that we’re going to work on, but there are
a lot of similarities. She’s saying that this one
is going to be separate. So my understanding is that
the motion is to go back to the two individual
recommendations that we had and to put the one
on trust first and we’re voting on
that one and yeah. As opposed to what
we had a moment ago when it was all combined in one. Right. So currently what’s
on the screen is back to the recommendation
one, building trust, and the recommendation
two, the support safe and effective human vaccines. And if you vote yes
in this motion, that means you’re voting yes on those two recommendations
as well? No, separate it out. Each separate. Yeah. You’re voting that they
would be two separate actions. Yep, but are we voting
in support of either of the two separate actions? Alright. We’re only voting
in support of the trust one. What happens after that,
happens after that. I see. But in the meantime
that we’re just voting saying that we want this trust
thing and that’s… Okay. Just a quick question. So if you voted… If we felt that very
strongly, as I do, about having number two be
number one, does that preclude that if you vote yes
on the trust thing? How is that handled then? I don’t think we’re
rank prioritizing these recommendations. So if in the report we want to put number two before
number one we can discuss that and decide later. So these are separate
recommendations that would then go in and
as we said before these are not concurrent. Like you would not… I’m sorry.
These are not sequential. So by building trust does not
mean that you would put pause on the support for safe
and effective vaccine until all trust is there. And building trust is not
involved necessarily the options you have there which I would
think would be very inhibitory for enthusiasm from… Correct. We are not
voting on the sub-bullets. Those are just brainstorming
ideas that could be considered as ways to build trust. And is this going to take
the blended version we had up there off the table, then? I don’t think so, but we can
get to recommendation number two after we do recommendation
number one. Okay. Great. Great. Thanks. Are people comfortable voting? Alright. So we have a
motion on the floor. Bob Sabatino. We’re voting on the trust. We are voting on only
recommendation number one, building trust through
a transparent mechanism by which all stakeholders
examine and discuss past
vaccine activities and potential adverse events to inform future vaccine
development in Lyme disease. Yes. Scott Cooper. Yes. Ben Beard. No. Wendy Adams. Yes. Rob Smith. Yes. Pat Smith. Yes. David Lieby. Yes. Allen Richards. Abstain. Lise Nigrovic. Um, abstain. Richard Horowitz. Yes. Dennis Dixon. Yes. Kristen Honey. Yes. John Aucott. Yes. So was somebody counting? So what was the… Two abstain. One negative. And how many for? Ten as I counted. So the motion passes. Thank you. Alright. So we passed the
recommendation number two… One. One. Now we still have to
discuss and entertain a motion for recommendation two
which is to support a safe and effective human vaccine
to prevent Lyme disease. And for this one I
would like to suggest that we cut-and-paste
the transparent mechanism from the first one, that whole
clause, the whole paragraph, and add it to recommendation
number two. So what we would be
voting on is support a safe and effective human vaccine
to prevent Lyme disease with a transparent mechanism by
which all stakeholders examine and discuss past vaccine
activities and embed it in – and I know that was part
of your recommendation, but I think calling that out at
a high level would be valuable. The only thing I
would put in the… Didn’t we just vote… … verbiage underneath people
with symptoms is it’s not clear. It should really be
people with symptoms with post Lyme disease
syndrome or people with symptoms post-tick bites. In other words it’s
not clear and to people with symptoms is anybody. We’re talking people with
symptoms who’ve had Lyme and other tick-borne diseases,
those are the ones who should be in the trials and
see what happens. But they might be
excluded from the trial. Weren’t they excluded
in the first trial? Because you couldn’t test. Right. So I was just a little
confused because I thought that the language
you just brought down was from number one.
Was I wrong about that? You were not wrong, but I was
suggesting that we add it back in so it’s very explicit
for any supporting safe and effective vaccine. So it’s embedded into this
and I know you had that… So it’s like getting
vaccinated in both arms. Didn’t we just say it? It seems redundant to me that
we have two recommendations that use the same language, except one says vaccine
and one says… Right and you know this
exact wording will not be in the report, but in terms
of getting it on the record and voting for recommendations,
I just think that the trust being
consistency over time, if we consistently
reiterate that we’re going to do a postmortem through
a transparent mechanism in all stakeholders, it will
hopefully increase support for a safe and effective
human vaccine. So yes, it is redundant. It is kind of a plus one, two recommendations encouraging
the first recommendation, but… Well, I think when
it finally comes down to writing a report that’s
going to be convincing to people who are out there and don’t
know a lot about these things, it doesn’t help to have
the same language repeated in two different
recommendations. So I would hope that
would be smoothed out. [ Pause ] Yeah, I just don’t want it to
get twisted in the record that, you know, vaccines are
being pushed or whatever. There are a fair
amount of caveats and we can finesse the language and make sure it’s
streamlined in the report. If you do number
one you don’t have to do it again in number two. Correct. You’re killing
two birds with one stone. Alright. People… Any more questions? Yeah. I’m just struggling. I’d like clarification
on the phrase, “and people with symptoms
who have had Lyme disease.” I guess I’m trying to think
through a clinical trial. If you have symptoms than if
you’re arguing that you… If you… We’ll just
take for example, if you’re saying you
have persistent symptoms, if you have chronic Lyme,
meaning you are already infected with Lyme then if you define it that way why would you include
those in a trial to be protected against Lyme if you
already have it. Right. Did you mean to exclude
people, Richard or to include? My concern is that the
patients in my practice who did take the prior
vaccine who had symptoms, and at that point before
they were my patients, some of them did get
ill from the vaccine. They had active symptomatology, but they didn’t know what the
symptoms necessarily were from. My concern is whether
it’s the adjuvants in some of the vaccines or whatever. There are people who have
basically hyper-stimulated immune systems with any
vaccine, forget LYMErix vaccine, any vaccine, and some
of them get very sick from whether its flu shots, meningococcal vaccines,
whatever. My concern is if
you do have a… if you did have a persistent
infection, let’s say Lyme, and you all of a sudden gave the
OspA vaccine or a chimeric tope, what would happen
to those people? And some people may not
know they have the disease. So in other words there
should be a screening process if you have migratory pain. To exclude them? To exclude them. Because this says… Well, no, no. Either exclude them or have
a subset to check the safety that if they happen to get into the trial you understand
what the consequences are. I think we’re getting
way ahead of ourselves. Actually, when we’ve looked at these other recommendations
it’s been a bold recommendation we voted on and then there
were various sub-pieces to that that were put in a parking
lot, because we have to have more discussion. I would see that as one of
those things and we can put it in a parking lot here, but I think it is a
whole another issue from what we’re talking about. So in terms of parking lot, if I can summarize the
conversation I just heard, we would want to take that
clause I added and make that a sub-bullet so it’s
explicitly included in this, but maybe, you know,
with more flexibility to finesse all the
language as well as the sub-bullets below it? Well, I actually wasn’t
talking about your clause. I was talking… Right. But the other
ones below it. Like we’re not voting on those. There’s flexibility to
revisit some of that. Kristen, I think that that’s
a very important question about vaccine safety
and the recommendations and who should be
excluded, you know. Whether or not it would
be recommended for people that population that
receives the vaccine, it’s important to study that. My point is, I don’t think they
would be included in a trial, because you can never…
The trial is to determine whether or not the vaccine worked, and you could never
answer that question. So they would be, by definition,
part of the exclusion criteria. They wouldn’t be
included in a trial. Not to say they shouldn’t
be studied, but just in a vaccine trial
that wouldn’t make sense to include them in that. It’s generally addressed
in any vaccine trials. So I think if it’s
a sub-bullet and not in bold, then it could just… It wouldn’t predominate
the discussion. [ Pause ] Do we have a motion
on the floor yet? Not yet. Do you want
to make one? Sure. I move that recommendation
number two to support a safe and effective human vaccine
to prevent Lyme disease with transparent mechanisms by
which all stakeholders examine and discuss past
vaccine activities and potential adverse events to inform future vaccine
development in Lyme disease. Second. Further discussion? Alright. Let’s vote. Bob Sabatino. No. Scott Cooper. Yes. Ben Beard. Yes. Wendy Adams. Yes. Rob Smith. Yes. Pat Smith. No. Uh, David Lieby. Yes. Allen Richards. Yes. Lise Nigrovic. Yes. Richard Horowitz. Yes. Dennis Dixon. Yes. Kristen Honey. Yes. John Aucott. Yes. So that passes. Okay. alright. So I think we have one… Do we have… Do we have one… your original recommendation
still, right? Uh huh. Something like PTLDS. Uh huh. Let’s just finish this. So can you bring up our
last recommendation, please? So your last… Is this your last
recommendation? Yep. [ Murmuring ] We can’t hear you. I don’t know if it’s redundant
in terms of what we talked about previously with the
pathogenesis treatment section. [ Pause ] Can we go back and look
at it and just compare? [ Pause ] You’re saying if it’s
duplicative with Wendy’s… Can you go back and look
at the WORD document? There we go. I didn’t know if we’d
already covered it. In Wendy’s. In the… Yeah. Uh huh. Which one
would it be under? It doesn’t look like it. I think it’s… I think it’s number one. Uh huh. I think it might be. [ Pause ] I think we should
do it just so… Yeah. Sure. Do it separately? Yeah. Okay. Yep. Is that okay with you? Yeah. So let’s… So the potential
action on the… up for discussion now
is continued research into the pathogenesis
that is immune response, cross-reactivity, auto-immunity,
bacterial persistence, persistence symptoms in patients who have received standard
treatment regiments. It’s open for discussion. I just… I would say,
“And other mechanisms,” because I’m not sure we’ve… So immune response,
cross-reactivity, auto-immunity, bacterial persistence,
and other mechanisms. So I’m not sure we’ve
covered the waterfront. Yes. [ Pause ] Here. Okay. So thinking forward to
the last discussion, do we want to expand
this so it’s Lyme disease and Lyme disease co-infections? [ Pause ] I think co-infections would be
one of the other mechanisms. Right. Is that okay,
Richard as another mechanism? That’s fine. Yeah. [ Pause ] Do we want to have it
as PTLDS or do we want to have something a little
less or a little broader? Well, our subcommittee
liked using that as having a little
more specificity, but the… You could… I guess you could say… Well, you say persistent
symptoms. So we don’t actually
say it here, we’re just saying
persistent symptoms. So we’re not… You’re saying up where it
says therapeutics and PTLDS. Yeah. So if we just
take that off. Yeah. You can take that off. Yeah. Take off the therapeutic. Therapeutics for PTLDS. Just take that off. Yep. Yeah. Did you add in the
co-infections? I thought you said it was
under other mechanisms. And co-infections
and other mechanisms. Okay. Bacterial persistence,
co-infections. Okay. [ Pause ] It says treatment
regimens for Lyme disease. It says tick-borne diseases. Or tick-borne diseases. Okay. So standard
treatment regimens for tick-borne diseases,
including Lyme disease. Yeah. [ Pause ] Other thoughts? [ Pause ] Alright. Do I have a motion? Did I make the motion? Not yet. Make a motion that
our group has a recommendation for continued research
into the pathogenesis and everything on that screen. Second. Further discussion? Alright. Let’s vote. Bob Sabatino. Yes. Scott Cooper. Yes. Ben Beard. Yes. Wendy Adams. Yes. Rob Smith. Yes. Pat Smith. Yes. Uh, David Lieby. Yes. Allen Richards. Yes. Lise Nigrovic. Yes. Richard Horowitz. Yes. Dennis Dixon. Yes. Kristen Honey. Yes. John Aucott. Yes. Unanimous. Alright. Is that… Have we conducted all the
business of the vaccine and therapeutics group? Uh huh. Alright. Thank you so much. So next we are going to
start a working dinner and the last report. So you’ll have 5 to 10
minutes to grab your dinner and use the restroom and
then we’ll start and hear about the other tick-borne
diseases and co-infections report. [ Break ] Welcome back to the final
phase of today’s work. Um, some process update, because
of the way the time flowed, we’re going to finish with
the other tick-borne diseases and co-infections subcommittee
report, but then we’re not going to do the division of writing
which was the final agenda item which is actually good because
then that gives you all a chance to think about what
you want to do. So your homework tonight
will be to think about which of the five groups EPI and
ecology, prevention, diagnosis, treatment, and access to care – which of those you
want to be on. We anticipate, hopefully, a
minimum of two co-lead writers for each group, but you can
sign up for as many as you want and so that’s your homework
tonight is to think about that and we’ll push that
item till tomorrow. So we’re going to go
now into Al and Richard and the other tick-borne
diseases and co-infection
subcommittee report. Good. Thank you, John. Uh, so when I go through these
slides what I gave to Jennifer and Allen and I decided this
would be a good idea to do it, we had created the
buckets earlier on. So there’s two main points
that we put up on the screen and you’ll see as we go through
the slides, these will fit under these recommendations. Recommendation number
one, “Allocate resources to improve the education,
diagnostics – and that would include
transmission via the blood supply in pregnancy
– and treatment of other tick-borne
diseases and co-infection’s.” And you’ll see that
there’s a part there also on a tick-borne disease
working group and recommendation number
two, “Improve the education and research on the pathogenesis
of alpha-gal meat allergy.” So Jennifer, if you go to
slide 10, diagnosis issue one. So if you take out potential
action two and three. Potential action two,
“Educate healthcare providers, clinical testing laboratories,
patients in the general public. These could be conducted by a collaborative effort
among medical agencies like HHS and private medical and
patient organizations, as well as knowledgeable
clinicians and scientists,” and potential action three,
“Create a tick-borne diseases and co-infection
multi-site working group – kind of the centers of excellence we’ve
been discussing – to have a collaborative
standardized approach to data collection and conduct
longitudinal cohort natural history studies of
sequelae or complications of treated infections.” So those… The one on education, of course,
that’s the bucket on education and the other one would
be regarding the creation of the tick-borne disease
multi-site working group kind of goes under diagnostics
and treatment, also. The next slide is slide
14, laboratory testing. Potential action one, two, four, and six are the ones
to cut-and-paste. Action one, “Develop
flowcharts or algorithms for clinical diagnosis in
laboratory testing for acute and chronic illnesses.” Potential action two,
“Promote independent validation of laboratory developed
tests utilizing panels of control samples that
are assessed blindly.” Potential action four, “Examine
ways to optimize sampling,” and I think this one is quite
an important and we discussed in our group, especially
with Marna, with Bartonella that you can’t always find
these in the blood and the skin, may actually be a
very good source, and also I was discussing
with one of my colleagues, Christian Perrone, who is an
infectious disease doctor. He had just written an article
recently in Medical Hypothesis about using blood
cell disruption to significantly
improve PCR detection. So I think that’s another way
of maybe optimizing sampling. We’ll think out-of-the-box
of ways we can do that. And potential action
six, “Expand the number of externally validated assays
to provide complete coverage of other tick-borne
diseases and co-infections.” So that will all go under
the improving diagnostics. Sorry to interrupt, but
potential action two, I don’t think they
cut-and-paste the entire thing. So you may want to
just make sure that potential action two… Yes, so potential action two,
“Promote independent validation of laboratory developed
tests utilizing panels of control samples that
are assessed blindly.” Yep. That’s it. [ Pause ] Okay. The next slide
is slide 19. So for Anaplasma Ehrlichia
treatment potential action one, “Educate healthcare providers
on the use of Doxycycline.” So that’s going to be a common
theme that we’ll be seeing as we discuss Rickettsia
infections like Rocky Mountain
spotted fever and the fact that it’s safe in below children
less than eight years old and also in pregnancy
in short courses. The next slide is
slide 21 on Babesia, potential action
one, two, and three. Potential action one
is, “Increase resources to improve diagnostics, broaden
Babesia species testing panels due to genetic diversity
and multiple species.” Potential action two,
“Provide healthcare education for not only family practice,
internal medicine doctors, but sub-specialists such as… including the signs, symptoms,
risks, laboratory evaluation, treatment challenges
of Babesiosis,” and potential action three,
“Conduct laboratory research and clinical trials to
evaluate any treatment regimens for Babesiosis since resistance to standard regimens
has been reported with increased morbidity
and mortality.” So those again, will go
under diagnostics, education, and clinical trials
for treatment. So those will fit in
the buckets we decided. Next slide is 23; other
Borrelia species, um, potential action
one, two, and three. Potential action one is,
“Improve public education on prevention of tick bites and
educate healthcare providers on the signs, symptoms,
and transmission of relapsing fever Borrelia.” Potential action
two, “Diagnostics: expand routine testing panels.” And potential action
three, “With treatment, evaluate efficacy of
treatment regimens against relapsing fever,
Borrelia transmitted by hard and soft ticks, especially
when different co-infections, are present as persistent
infection has been reported.” The next slide is 24 under
deer tick virus Powassan. Potential actions one and two at
the bottom, “Increased resources for research into
effective treatment; since we have none
at this point. And potential action two,
“Conduct research animal models into the modes of transmission
and whether persistence exists after acute infection.” And this is particularly
a problem, because with the flaviviruses
we know that with Zika virus and West Nile there
can be persistence and there can also be
transmission in pregnancy and these are big gaps
that we have at this point. We just don’t understand
the transmission and even with tick-borne encephalitis
virus it can be transmitted in Europe by raw goat milk. So looking at transmission of
some of these flaviviruses… I think it’s an important
gap we need to look at. Number 25 Rickettsia. At the bottom, potential
actions one and two, “Educate healthcare providers on the nonspecific
signs and symptoms. Use Doxycycline as
first-line therapy in children and in pregnancy.” And potential action two, “Treat Rocky Mountain
spotted fever presumptively. Never delay. Stop treatment.” So again, this fits under the
education and diagnostics. And slide 27, Bartonella, potential action
one, four, and five. Potential action one, “Improve
and expand diagnostic assays. Because of the increased range of species explore how
multiple pathogens interact such as Lyme and Bartonella. Does that have an
effect on immunity?” Potential action four, “Conduct
animal and human clinical trials to evaluate more effective
treatment protocols as Bartonella has been shown
to persist despite single or a combination therapy.” And potential action
five, “Allocate resources to conduct research
to determine the risk of transmitting multiple
tick-borne pathogens via the blood supply;” since we know
that Anaplasma, Rickettsia, like Rocky Mountain spotted
fever, Babesia, Bartonella, relapsing fever – these
can all be transmitted by the blood supply. And slide 28, the role
of other pathogens and sources of inflammation. Potential action one, “Review
the role of overlapping causes of inflammation in
Lyme disease patients, such as mycoplasma infections
and environmental toxins. These have both been associated
with autoimmune phenomenon.” The reason I think this is
important in part is because, for example, for patients with rheumatoid arthritis they
use Plaquenil and Minocycline as a DMARD regimen, but what we
don’t know is they’ve also found mycoplasma species in patients with rheumatological diseases
causing increased in cytokine. So maybe it’s not just
modifying inflammation, but actually hitting infections. And potential action two,
“Conduct research on the role of free radical oxidative stress in cytokine production
during tick-borne infection. Downstream effects of
inflammation may result in disabling symptoms. Allocate resources to
conduct clinical trials to identify contributing causes
and confounding factors.” And Ben, that was
going back a little bit to what you were saying
before about kind of a lot of chronic diseases and just
seeing how this may play out. And finally, the last slide is
on Alpha-gal which is slide 30, um, possible actions
one and three. Action one, “Increase education
and awareness, pre-diagnosis, and counseling after diagnosis. Labeling on food
may be inadequate.” And possible action
three, “Increase funding for immunologic and animal
model research to identify and better understand
the tick proteins that cause Alpha-gal
meat allergy.” [ Murmuring ] Richard, so do you think
you can address all of these sub-bullets
in the document? I mean, they’re just… So, I’m just asking. I mean, the detail is great. I’m just wondering if we… Are there any you can roll
up into the top bullet? So the top bullet, I mean, ultimately the education
obviously is crucial, because it’s in our document. I mean, there are
young children that die of Rocky Mountain spotted fever because the providers don’t know
the early clinical symptoms. The diagnostics are problematic
because we have so many species at this point of some of
these different infections, and so for example,
relapsing fever, Borrelia sensu lato species or
some of the southern species, you know, Bessettii and Lanai
now in California and others, the problem is if we
don’t include these in diagnostic panels
we can’t be sure really when people are getting sick. So I think expanding the
diagnostics is important, and because as we
talked about these, these can be transmitted via the
blood supply and in pregnancy. And the treatment, you know,
is fine for some of these. I mean obviously doxy’s
great for anaplasma ehrlichia and Rocky Mountain
spotted fever tick. It’s curative when you get it
early enough, but the problem is that some of these – Sam Telford
was pointing out in our group that there are now genes
that cause resistance to Atovaquone and Azithromycin. I didn’t know that. I didn’t know that’s why
my patients weren’t always responding to it. Um, we have seen
persistence of Bartonella. It’s in the literature and we’ve
seen it in clinical practice. So I do believe and Allen,
please kick in on this one, I mean the co-infections
at least clinically from my practice,
they’re playing a big role and I think education
diagnosis – your treatment. Now all the different
points underneath, I mean obviously this can all
be tweaked and I think put into maybe simpler formats,
but things like flowcharts or algorithms, CME
for physicians, even if we teach doctors about these different
tick-borne co-infections and other tick-borne infections,
it’s a lot of information. I mean I think we need
to figure out easy ways to educate the doctors,
educate the public on them. Without education, right,
we’re not going to be able to move forward,
but the diagnostics and treatment was a… Yeah, please Allen, kick in. Yeah, I think… As we talked about earlier, a lot of this just should
marry-up well with the Lyme. So the diagnostics
certainly and education, that was our top item. So, not only the clinicians,
but the laboratorian’s and the general public
patients, everyone, so. So and we’re not… We don’t have a subsection for “other tick-borne
infections,” right? In our five or six, it’s
all getting built in? Correct. Yes. So a lot of this
will go into testing. A lot of this is
just going to get… So once we approve this bold
that will just get folded into the diagnosis and
education sections? Yeah, there actually isn’t an
education section right now. That’s right… I mean the side,
kind of the sidebar. The sidebar, yep. Uh huh. [ Pause ] So any… We don’t have to
wordsmith the sub-bullets, but the top level
recommendations. So I make a motion that one
of our recommendations will be “To allocate resources
to improve the education, diagnostics, including
transmission via the blood supply and pregnancy
and treatment of other tick-borne
diseases and co-infections.” I second the motion. Further discussion? The only question
I have is on the “including transmission via
blood supply in pregnancy,” lest it be assumed that all of these other tick-borne
diseases are transmitted that way. Maybe that’s not obvious… I mean, if there’s
a way of saying, “you want to look into that.” “Improve education, diagnostics,
including transmission… ” I don’t know if anybody
else has ideas about that. Are you saying take that section
and put it down as a bullet, including the “transmission
via blood supply” instead of just leave it
as “diagnostics?” Um, yeah, I just wasn’t
sure whether it was making a statement about transmission
as opposed to, “we want to examine transmission
in these newer agents.” Yes, some of them have
been found to be… I know. Yeah, certainly
with Babesia it’s a big… blood supply is a big issue. So I guess you… I guess it’s important
that you have it in there, but that was my concern. Yeah. Okay. Alright. Are we ready
for a vote? Okay. I’m going to go backwards so Bob doesn’t always
have to be first. Um, Kristen Honey. Yes. Dennis Dixon. Yes. Richard Horowitz. Yes. Lise Nigrovic. Yes. Allen Richards. Yes. David Lieby. Yes. Pat Smith. Yes. Rob Smith. Yes. Wendy Adams. Yes. Ben Beard. Yes. Scott Cooper. Yes. Bob Sabatino. Yes. And John Aucott. Yes. So it passes unanimously. So we’ll go to the
second recommendation. [ Pause ] So this is short and sweet. So I just have to
point out, again, that this Alpha-gal
meat allergy, I think the subcommittee
had the most, somewhat the most fun with,
because they actually came from the comments and we
like had to learn about it and it was really actually
kind of a neat thing to see how the comments
actually generated this. This wasn’t in the
original outline at all. So it was kind of a fun one. I learned a lot listening
to you guys talk about that. So any discussion on this? “Improve the education
research on the pathogenesis of alpha meat gal allergy.” Do I hear a motion? So moved. Second Second. Discussion? alright. We’ll start
in the middle. Rob Smith. Yes. Pat Smith. Yes. David Lieby. Yes. Allen Richards. Yes. Lise Nigrovic. Yes. Richard Horowitz. Yes. Dennis Dixon. Yes. Kristen Honey. Yes. Bob Sabatino. Yes. Scott Cooper. Yes. Ben Beard. Yes. Wendy Adams. Yes. And I started
with Rob, right. Yeah. alright. John Aucott, yes. So all unanimous. alright. And those
were your only two. We went through the… Excellent. Alright. So we’re now at 6:47. Again, we’re going to push
the writing assignments, not really assignments,
writing volunteers. We’re looking for a couple
people to at least two kind of co-lead the writing. Most of the writing’s around
the pre-existing subcommittees, like testing, diagnosis,
EPI and ecology, access to care, but some isn’t. Prevention, for instance, isn’t. So we need some volunteers
to lead prevention which is being pulled in from
different areas and so think about that and thank you for
your incredible work today. And I just want to
comment on the collegiality and despite obvious important
issues we’re divided on, just the respect and great
thoughts and ability to work through these things to really
come up with a really balanced, thoughtful, collegial document. So I really appreciate
everyone’s efforts on that. It’s really spectacular
and I’ll see you all… Oh, Pat… Sorry. No, this is very
important and short. I just want to make sure
that the missing 15 minutes that were recorded in-house, or
whatever you want to call it, get put on the website so that
no one thinks there’s any issue. You’re talking about the… your and Ben’s review or… No, she’s talking about the 15
minutes of the webcast that… Oh. Yes. The logistics. Right. Okay and one
other quickie and that is about the intake documents. How… I don’t know that
we ever heard how is that going to be handled? What do you mean by
intake documents? The government… I always call them intake, because… Yeah. The inventory
document is on the agenda, if you look at tomorrow’s
agenda. Oh, okay. Yeah. Sorry. I was too busy
looking at today’s. I’m sorry. Did you answer her question
about the 15 minutes? So there’s no way to
get back the 15 minutes, but in the meeting summary
as well as the transcript that we have, we’ll cover
those 15 minutes as well as when we started back,
which covered the 15 minutes that was during the
time that it crashed. So there won’t be an additional
audio for that 15 minutes. It will be included
in the transcript and the meeting summary. [ Pause ] Correct. There’s no way for
us to splice in the audio that we have that is separate
from what the live stream has. So there will be that 15
minutes, but it will be covered in the transcript as well
as the meeting summary. Alright. I’ll take
a motion to adjourn. So moved. All in
favor say, “Aye.” Aye. Opposed. Abstentions. The meeting’s adjourned. Thank you. Woohoo!

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