>> Martin Blaser: Before we go on to our council discussion,
I just want to make a thanks to the staff of PACCARB, who have really enabled all this
work.
I want to thank Bruce, who served for a good half of this process before he left the federal
government.
Our -- Jomana Musmar, who has led it since Bruce, and even before.
Laura Gottschalk, MacKenzie Robertson, Tiffany Archuleta -- I well, and others.
So thank you to the staff.
Now it is time for the council to --
[applause]
And now it is time for the council to have public discussion.
Each of you has seen this report in its draft along the way.
You've seen it maybe too many times.
But now is an opportunity to speak in public about your thoughts.
Councilors.
Just so that there is some discussion, I would just like to say that I am in very high agreement
with this report, and we were very -- it was difficult to come up with the top 10, because
there were so many of value.
And I'd like to propose an eleventh.
It will not go into the report as number 11, but just for the purpose of public announcement,
and that has to do with human therapeutics, item 3.2, page 18, sections 3.2 and 3.3.
It's about the development of narrow spectrum antibiotics.
This is a little future oriented.
It's not necessarily for the current round of antibiotic resistant organisms.
But it's an attempt to lower the ecological damage of antibiotics on our microbiomes.
And I'm predicting that the future of antibiotic development will include more and more of
narrow spectrum, once we have adequate diagnostics that will enable us to find these organisms.
And so in our report, we asked for the continued development and refinement of such of these
and to improve the regulatory pathway, and to have further ways to make the development
of narrow spectrum antibiotics more feasible and bring it to the market sooner.
Dr. Laxminarayan.
>> Ramanan Laxminarayan: Thanks, Marty.
So again, I'd like to echo what you said about you know, this having been a long process
but included a lot of people who are not here today, and I think we can be quite happy with
what has emerged from the process.
Just three points.
One is, for those seeing it for the first time, you're probably wondering this looks
like a lot of money.
There's many parts which call for innovation institutes, for, you know, rewards and mechanisms
and so forth, and whether all of this will actually come to pass.
I think that the way to read this would be to sort of see perhaps that there are things
that could happen in the more immediate term, such as for instance, the clinical trials
network, which could lower the cost of drug development.
That could happen very soon.
You know, regulatory pathways that were optimized and, you know, as we've already seen, already
happening to some extent you know, at FDA.
Now these are things that could happen right away without the need for the big bucks, which
will undoubtedly be necessary.
So I don't think, you know, those seeing it for the first time should be worried as, you
know, as this being a very expensive proposition that will never see the light of day.
It does not have to be adopted in its entirety.
It can be adopted in a sequential manner, you know, with starting with the things that
are the most feasible to do.
I think the second point here to make is that I'm not, I mean, I'm aware of these processes
in other countries, and you know we've been involved in this process in the European side
as well with IMI.
This may be the first process that has actually looked at human and animal use simultaneously
anywhere in the world.
So, I think it has a lot of merit from having that cross talk as part of the discussion.
And I think it will be important for us to at this stage, not lose sight of it, and have
these split off into separate allocations.
I think it's as important to get money for vaccines for animals as it is for humans,
and I think the way in which we advocate it will be important.
And I think the third part of it is really in terms of time length, which these obviously
are things which will take a very long period of time, so hopefully our co-chairs will be
advocating for this report very strongly with the powers that be to make sure that it goes
into practice as soon as possible.
Thank you.
>> Martin Blaser: Thank you for your comments.
I'd like to call on Alicia Cole, who is on the phone.
Alisha, can you hear us?
>> Alicia Cole: Yes, I can.
Yes, I can.
Thank you.
>> Martin Blaser: The floor is yours.
>> Alicia Cole: Thank you.
I wanted to commend my fellow committee members for the report, and for all the hard work
that everyone has done.
I just had one comment on -- Angie, there was a section on point number three where
you talked about funding of diagnostic outcome studies.
And I noticed throughout some of our bullet points we call out various federal agencies,
and it's probably just an oversight, but I think we need to also include the V.A.
Especially where we talk about outcome studies, because the V.A. is the largest integrated
health system in the U.S.
They've got 1700 [unintelligible], and so where we're looking at outcomes and other
point of care studies, I think they should be included.
I think they bring a strong voice to the table.
They're having great success, and I think we need to incorporate them in a very specific
called-out way and not just implied.
So I'd like to make that recommendation.
Thank you.
>> Angela Caliendo: So just a question -- clarification, Alisha.
Are you talking about the V.A. funding these studies, or the V.A. being funded for these
studies?
>> Alicia Cole: Being funded for these studies.
>> Angela Caliendo: Okay, so the organizations that we listed
were those that would actually provide the funding.
>> Alicia Cole: Okay.
>> Martin Blaser: And so the V.A. could be a recipient, and
as you point out, is a very good, large scale way to test ideas and products.
>> Alicia Cole: Absolutely.
Thank you for the clarification.
>> Martin Blaser: Thank you.
I call on Dr. Jungman.
>> Elizabeth Jungman: Thank you.
So echoing the thanks for the work, and I know that I in particular had a lot of comments
on many of the drafts, and so I appreciate the really collegial discussion about that
and appreciate that.
I was just kind of picking up on Ramanan's point.
The, you know, full funding of this report is, of these recommendations, is highly unlikely,
and there's a really, you know, a near future fiscal environment.
But even if it was in any circumstance where we are talking about using tax payer dollars
to fund private company activities, that's a big deal.
And accepting that the economic challenges here are really daunting, I think that's something
that, you know, we just have to take really seriously.
And so, you know, we need to really clearly identify what it is we're trying to incentivize,
and our basis for believing that that incentive works, and our rational for believing that
that investment will have more of an impact on spurring development than other options.
And so, you know, this report does that I think at a very high level.
And the next step, you know, for people who are taking this report and moving it forward
will be to, you know, to identify, you know, really some of the details here.
Like what are the specific vaccines that we want to pull out of the incentive structure?
You know, why don't we think that the market is adequate to, you know, reward a diagnostic
to couple with any given antibiotic?
Or you know, how exactly do market entry rewards work?
And so you know, this is, it's already 46 recommendations.
There's only so much you can do in a report, but just to sort of flag the next steps.
And so you know, I think one way to look at this report is it's a fairly high level -- I
mean there's a lot of detail, but still within any of these, for folks who've been involved
with discussions in any of these areas for a long time, it's a fairly high level, you
know, menu of options of things that could spur development.
And it will start I think as a good starting point for the difficult work to come for making
the case for any individual intervention.
So just a -- just adding that layer on.
Thanks.
>> Martin Blaser: And remember, our charge as scientists, as
practitioners in this realm is to come up with the most scientifically sound and feasible
ways to move forward in this idea.
We will rely on our colleagues on Capitol Hill to allocate the funds, and our colleagues
in the federal government to utilize the funds.
I was very pleased by a number of the reports in the last two days where the presenter said,
"Well we, considering PACCARB's recommendations, we have done the following."
So I'm hopeful that we will get a similar response in years to come.
Are there further comments?
So therefore I think it's time, Jomana, for us to take a vote.
>> Jomana Musmar: Sure.
Thank you Dr. Blaser, and thank you to our chairs for working with us on the development
of this report.
It's been a long time coming, and we've come to this day.
So in compliance with the Federal Advisory Committee Act, all deliberations of FACA advisory
committee seeking to reach consensus on advice to be given to the department are to occur
in a public meeting , such as this one, and consensus requires a quorum, which equals
half of the number of voting members plus one.
For the advisory council, for this one, a minimum of eight votes are required for the
passage of this report to the Secretary of Health and Human Services, Tom Pins [sic].
I will call on our voting members for their decision on the current version as it stands
right now on our website.
And for the record, please state either yay or nay when your name is called.
I'll start to my left with our first voting member, Martin Blaser.
>> Martin Blaser: Yay.
>> Jomana Musmar: Mike Apley, are you on the line with us?
>> Mike Apley: I am, and I vote yay.
>> Jomana Musmar: Thank you, Mike.
Helen Boucher?
>> Helen Boucher: Yay.
>> Jomana Musmar: Angie Caliendo?
>> Angela Caliendo: Yay.
>> Jomana Musmar: Alicia Cole, are you with us on the line still?
>> Alicia Cole: Yes, I am.
Yay.
>> Jomana Musmar: Thank you.
Sara Cosgrove?
>> Sara Cosgrove: Yay.
>> Jomana Musmar: Thank you.
Peter Davies?
>> Peter Davies: Yay.
>> Jomana Musmar: Thank you.
Lonnie King?
>> Lonnie King: Yay.
Yay.
>> Jomana Musmar: Thank you.
Kent Kester?
>> Kent Kester: Yay.
>> Jomana Musmar: Ramanan Laxminarayan?
>> Ramanan Laxminarayan: Yay.
>> Jomana Musmar: Thank you.
Aileen Marty?
>> Aileen Marty: Yay.
>> Jomana Musmar: Thank you.
John Rex?
>> John Rex: Yay.
>> Jomana Musmar: >> Tom Shryock?
>> Tom Shryock: Yay.
>> Jomana Musmar: In both senses of the meaning.
[laughter]
Randy Singer?
>> Randall Singer: Yay.
>> Jomana Musmar: And Bob Weinstein?
>> Robert Weinstein: Yay.
>> Jomana Musmar: Thank you.
The report passes through a unanimous vote.
>> Martin Blaser: Thank you, council, for all the work that
has gone into this.
I'm so -- I'd say we're all so indebted to our co-chairs for this process, to Dr. Weinstein
and Dr. Kester, to the co-chairs of the working groups, to all the working groups.
An enormous amount of work.
We have a product that we can bring forward into the realm of consideration.
And that's our job, and shortly we're going to start working on stewardship.
So you can take a deep breath for a few minutes and then we will begin again, but I just want
to thank everybody for a terrific job that's well done, and I'm pleased that we were able
to -- for us all to agree.
Good, good.
So, now it is time in this meeting for our public comment.
And as in the past, we will listen to any public comment.
Priority has been given to members of the public that have registered online.
We ask the commenters to limit their comments to two minutes or less.
As a reminder, this is not a question and answer period, only an opportunity to voice
public opinion.
All members of the public are encouraged to send in their full comments by emailing carb@hhs.gov.
And public comments emailed to the CARB mailbox by the deadline indicated in the federal register
and website are available at the registration desk.
So, I'd like to call on our first commenter today.
We have four people who have registered.
First commenter is Louis Mendelson from AllerQuest LLC.
Mr. Mendelson.
>> Louis Mendelson: Thank you very much to PACCARB for the opportunity
to present my comments.
I have been in the practice of allergy and immunology since 1972.
I've been involved with penicillin allergy research since that time.
I'm also from the same school as many of you, that it's better to put your seat belt on
before the accident, and not after the car accident.
AllerQuest is a small company owned by myself and two other allergists and a biochemist.
We formed this in 2005 when the previous manufacturer of PRE-PEN, the only penicillin skin testing
approved by the FDA, stopped production, and no other company would bring it back to market.
Therefore, no one would be able to test for penicillin allergy again.
Since bringing back PRE-PEN to the market in 2009, we have been working to improve the
product by expanding the panel of penicillin reagents in this test kit to identify even
more people who carry IGE antibodies against what are more penicillin determinatives.
Such tests are critical to antibiotic stewardship, understanding, and stemming antibiotic resistance.
Of course, while 30 million people are labeled as penicillin allergic, 90 percent or more
of these can currently take penicillin without risk of severe reactions.
Without penicillin skin testing, millions of patients are needlessly diverted to broad
spectrum alternatives, such as vancomycin or [unintelligible], which are associated
with a higher degree of infection [unintelligible], as well as a higher risk of clinical complications
along the hospital stage.
Recognizing these costs, the Center for Disease Control in 2016 issued a fact sheet for all
health care providers advising, "The use of broad spectrum antibiotics in patients labeled
as penicillin allergic is associated with higher health care cost, increase of antibiotic
resistance, and sub-optimal antibiotic therapy.
And encourage penicillin skin testing as a reliable and useful method for evaluating
IGE penicillin allergy."
A great number of public health institutions are joining CDC in recognizing the important
role that thorough penicillin evaluation can play in antibiotic stewardship.
The American Academy of Asthma Allergy and Immunology issued its first position statement
in 10 years to address the topic, strongly encouraging, when indicated, indicated from
the history, more widespread and routine performance of penicillin skin testing to reduce cost
of care, enhance patient safety --
>> Martin Blaser: Your time is just about up.
>> Louis Mendelson: Okay.
And improve outcome of care.
Penicillin allergy evaluation has been supported by the American Board of Internal Medicine,
the Infectious Disease Society, the Working College of Allergy and Immunology, and the
Society of Healthcare and Immunology.
We hope this analysis will provide awareness to healthcare providers that penicillin allergy
testing has potential impact on stemming antibiotic resistance.
I thank you very much for allowing me to say this.
>> Martin Blaser: Thank you.
I'd now like to call on Steven Roach from Food Animal Concerns Trust.
Mr. Roach.
>> Steven Roach: Yeah, I'd like to take us back to this morning's
discussion about prevention control.
So and again, as always I talk about animal agriculture.
So infection prevention in animal agriculture from our perspective is primarily related
to farm management practices that lead to the -- to disease.
In both cattle and swine production, co-mingling animals from different sources is still a
problem that is often addressed with routine antibiotics.
Most feedlot cattle receive macrolide antibiotics to address health problems created by inappropriate
diets.
We need practices that are associated with illnesses in both cattle and swine.
The poultry industry has made some changes by cleaning up their hatcheries, which has
resulted in them no longer needing to reuse antibiotics in the hatchery cases.
In many cases, economics drive these choices.
And many of these practices are based on access to inexpensive antibiotics to address consequences.
So when we talk about prevention, we also have to think about -- highly about economics
and animal agriculture.
In terms of federal agencies, there are several issues that I would like the council to take
into consideration.
First, there is no federal authority for on-farm food safety for meat and poultry.
FDA has authority over feed and drugs, but there is no authority for addressing human
pathogens on farms, either resistant or not.
So even if we have a multi-drug resistant outbreaks associated with animal products
traced back to the farm, is dependent on farms voluntarily allowing public health officials
access.
And there is no authority to require farms to take steps to control risks.
And the other thing that's a related issue is that we have no system in place to collect
actionable data on antibiotic use or resistant bacteria on farm.
Several council members are funded by FDA to develop systems to collect antibiotic use
data, but it is unclear whether these efforts will be sustained over the long run.
So these are short term grants.
USDA has some data collection programs, but I ask the council to explore whether the quality
of data collected by these USDA programs is adequate to identify problems and solutions.
Dr. Craig at CDC described CDC's efforts to create a system to detect, respond, prevent,
and innovate in human medicine.
I would say in animal agriculture, detection is rudimentary and the other three are nonexistent.
And a final comment is that Dr. Flynn mentioned lack of resources for some of these programs
within the FDA, but the agency has not requested the new -- in its budget request these new
resources.
So we do have a problem where, I'm kind of disturbed to see agencies saying we don't
have the resources, but if they're not requested, it's much harder to get Congress to actually
provide the resources.
So we really need the agencies to ask.
Thank you.
>> Martin Blaser: Thank you for your comment.
I now call on Amanda Jessick [spelled phonetically] from the Infectious Disease Society of America.
She does not seem to be here.
So I now call on Kevin Kavanagh, Health Watch USA.
Mr. Kavanagh, Dr. Kavanagh.
>> Kevin Kavanagh: Well, thank you very much.
As a recipient of bone morphogenetic protein to my neck, I feel the FDA's embracing of
an effort to increase the speed of approval for device drug hybrids raises significant
safety concerns.
In addition, I was concerned regarding AHRQ's presentation on chlorohexidine, especially
in light of the integrity issues which have been raised regarding the reduced MRSA study.
This was also a subject of a recent Reuter's investigative report by Deborah Nelson, which
centered on conflicts of interest and on FDA warnings against this type of chlorohexidine
use.
On the Health Watch USA website, there's a YouTube presentation by Matthias Mievault
[spelled phonetically], who raises serious concerns about research integrity problems,
including the recent meta-analysis, which is performed by the World Health Organization
for their current recommendations regarding surgical antisepsis using chlorohexidine.
And of course, you'll all remember the NQF chlorohexidine Charles Denim [spelled phonetically]
debacle.
All of this I feel is starting to form a pattern, which I feel needs careful evaluation, and
is also of significant concern.
Finally, it would be very interesting to have a world map which designates countries having
over the counter antibiotic sales, and to determine what percentage of the world's population
currently can obtain an antibiotic without a prescription.
Thank you.
>> Martin Blaser: Thank you.
Does anyone have any further comments?
Yes, please.
Please identify yourself.
>> Lisa McGiffert I'm Lisa McGiffert with Consumer's Union,
and a couple of comments about the report, even though I know you've already voted on
it, but as expressed by Elizabeth Jungman, Consumer's Union is also concerned with the
use of taxpayer money for private enterprise as envisioned by this report.
I'd like to also talk about post market studies.
Numerous recommendations to speed through FDA approval of devices and diagnostic tests
with a post market study.
These studies often don't start for years after the device is out there and they have
three to five years before reporting results, which could lead to many patients being harmed
or misdiagnosed without coming to the attention of the FDA.
So I recommend that we -- that you look into specifying that these studies begin immediately.
That is, in exchange for putting untested products on the market due to logistical problems,
like responding to a rare bacteria, the companies and healthcare providers using these untested
products should be required to sign an agreement to submit data regarding its use and results
as soon as it starts, and for that data to be looked at as you go along as far as the
results to make sure that patients aren't harmed and that they're actually working.
Thank you.
>> Martin Blaser: Thank you.
Do we have any further comments?
So that closes the period of public comment.
Now we go back to the council and ask does anyone have any final comments to make?
Hearing none, this meeting is adjourned.
Our next meeting is planned for January 24 to 25, 2018.
Please visit our website for all updates, including the final report from this council
from this meeting.
Thank you.
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