HHS Listening Sessions on AMR | February 2020 | Day 1, Part 1

>>Martin Blaser: Good morning, everyone. Although there’s a line outside, we’re going
to get started because we don’t want to get too far behind schedule. We have a very busy agenda this morning. So, I — my name Martin Blaser. I’m from Rutgers University. I would like to welcome everyone to Washington
and thank you all for attending the special listening session on antimicrobial resistance. We have convened a number of experts to hear
about innovations that may help us to fight antibacterial resistance, including new antibiotics,
alternative therapies, vaccines, diagnostics, and animal health management products and
practices. Although we are not here as part of any activities
to develop consensus or recommendations, it is important to continue the discussion of
ways to fight antibiotics resistance, highlight success stories, and look at the challenges
that remain. We are now in the early stages of an infectious
disease pandemic. We are faced with a rapidly spreading agent
for which there are no currently effective treatment. Sounds a lot like AMR. This epidemic teaches us how vulnerable we
remain to infectious diseases, which do not respect any political boundaries. To paraphrase Josh Lederberg, we must use
our wits against its genes. Today we are engaged in a similar battle. Different agents, same problem. The infrastructure that we are building for
one problem, AMR, helps us respond to another, coronavirus. That’s the context for the discussions over
these next couple of days. I’ll turn it over to our co-chair, Dr. Lonnie
King.>>Lonnie King: Good morning, everybody. Dr. Blaser, thanks very much. In just a little bit, we’ll have some opening
remarks by two distinguished guests, the Dep. SG, RADM Erica Schwartz, and Assoc. Dep. Sec. Charles Keckler. We’re extremely pleased to have these top
public health officials joining us, and it certainly underscores the importance of this
issue that we are addressing over the next two days. RADM Schwartz will also recognize some of
our individuals whom we know very well, and, on a personal basis, let me tell you how much
we appreciate your contributions and friendship that we’ll enjoy going into the future. And we will join her in thanking each of them
for their service and dedication. I’ll turn it over to Jomana now for roll call.>>Jomana Musmar: Hi. Thank you, and good morning to everyone, and
welcome to D.C. My name is Jomana Musmar, as Dr. King had
mentioned, and I’m a public health advisor in the Office of Infectious Diseases and HIV/AIDS
Policy, within the Office of the Assistant Secretary for Health, and I’ll be helping
to lead the program today and tomorrow. A sincere thank you and welcome to all of
our presenters, attendees, and stakeholders for joining us today, including those who
provided and have signed up for public comment. For those of you that have sent us public
comment, we have printed those out, and they’re outside. The goal of this listening session today is
to learn about ways to improve the programs and policies related to antibiotic resistance
that will contribute to the overall health of our country. We will not be asking the group to vote on
any matters, make any recommendations, or reach a consensus view during this meeting
today. The purpose of today is to discuss the one
health issue surrounding antimicrobial resistance, with an exchange of ideas for informational
purposes only. Before we start, there are a few things we
should all know. First, that this meeting is conducted via
teleconference, is being streamed live, and is open to the public. There will be time for public comment at the
end of this meeting today, so if you haven’t registered, please be sure to register so
you can have your line in the queue. Second, the proceedings taking place will
be conducted as a listening session mainly, as I mentioned. The group will not be deliberating, taking
votes on matters, or making recommendations today. We will be — and we will be soliciting views
on an individual basis from the folks around the table. I would personally like to thank my team,
especially. Dr. Marques Meercheck [phonetic sp], Berlin
Memoroh [phonetic sp], Haley Krem, and Jennifer Adona, on their efforts to help plan and adapt
to the many changes related to this meeting. I’ll go through a call for all participants
with us today. Please let us know if you are present by stating,
“Here.” And we’ll start to my left and Marty Blaser.>>Martin Blaser: Here.>>Jomana Musmar: Michael Apley?>>Michael Apley: Here.>>Jomana Musmar: Stephanie Black?>>Stephanie Black: Here.>>Jomana Musmar: Helen Boucher?>>Helen Boucher: Here.>>Jomana Musmar: Sara Cosgrove?>>Sara Cosgrove: Here.>>Jomana Musmar: Paula Fedorka-Cray?>>Paula Fedorka-Cray: Here.>>Jomana Musmar: Christine Ginocchio?>>Christine Ginocchio: Here.>>Jomana Musmar: Locke Karriker?>>Locke Karriker: Here.>>Jomana Musmar: Lonnie King?>>Lonnie King: Here.>>Jomana Musmar: Kent Kester?>>Kent Kester: Here.>>Jomana Musmar: Elaine Larson?>>Elaine Larson: Here.>>Jomana Musmar: Ramanan Laxminarayan?>>Ramanan Laxminarayan: Here.>>Jomana Musmar: Armando Nahum?>>Armando Nahum: Here.>>Jomana Musmar: Paul Plummer?>>Paul Plummer: Here.>>Jomana Musmar: David White?>>David White: Here.>>Jomana Musmar: Denise Tony [phonetic sp]?>>Denise Tony: Here.>>Jomana Musmar: I know Alice Johnson is
not able to join us today. Are you on the line, Alice? Okay. Tiffany Lee?>>Tiffany Lee: Here.>>Jomana Musmar: Kathy Talkington?>>Kathy Talkington: Here.>>Jomana Musmar: CDC. Are you at the table?>>Martin Blaser: Denise –>>Jomana Musmar: Oh. Denise Cardo. She’s over there. I see her [laughs]. NIH?>>Dennis Dixon: Here.>>Jomana Musmar: Thank you, Dennis Dixon. BARDA?>>Male Speaker: Here.>>Jomana Musmar: Christopher Helchinns [phonetic
sp]? CMS, are you on the line? No? Okay. FDA, Bill Flynn?>>Dan Sigelman: Bill will be here later. I’m here. Dan Sigelman.>>Jomana Musmar: Thank you, Dan. OGA?>>Lynn Filpi: Here.>>Jomana Musmar: Thank you, Lynn Filpi. DOD, Paige Waterman?>>Paige Waterman: Here.>>Jomana Musmar: Thank you. USDA, Chelsea Shible [phonetic sp]? On –>>Female Speaker: She’s coming.>>Jomana Musmar: Okay. Alright. USDA, on behalf of Jeff Silverstein?>>Nina Romandson [phonetic sp]: Nina Romandson,
[unintelligible].>>Jomana Musmar: Thank you. And, then, Emilio Esteban for USDA, coming
later? Okay. No, never mind. Alright. Thanks. Well, just a few more housekeeping items to
remember. I ask that all participants identify themselves
when speaking into the microphones because this session is being streamed live, so they
have to hear you. It’s important that this is on. Please push the button before speaking and
turn it off after you’re done. Also, please make sure that you identify yourself
before speaking for attribution purposes, because we are taking notes and there is a
transcription as well. And, let’s see, this session is also being
recorded. It’s being transcribed. I now have the pleasure to introduce our department’s
Dep. SG, RADM Erica Schwartz. Thank you.>>Erica Schwartz: Good morning, everyone. The first thing I had to figure out is how
to get on this stage, so I’m successful this morning. Thank you, Dr. Musmar. Thank you, Dr. Blaser. And thank you, Dr. King. I really want to thank you for the opportunity
to address the participants at this meeting on the critical public health issues of — issue
of antibiotic resistance. On behalf of the SG, Vice Admiral Jerome Adams,
I would like to express our appreciation for your work in assembling this fantastic collection
of experts to discuss the importance of antibiotic resistance. The Surgeon General’s top priorities include
major public health challenges, such as opioid and tobacco addiction, and emerging public
health threats, of which antibiotic-resistant bacteria is one of the most crucial. Antibiotic resistance is a national and global
concern. And combatting the spread of resistance is
among the top priorities of the Department of Health and Human Services and the entire
United States government. The phenomenon of resistance threatens the
core of our health care system. Because the challenge of combatting antibiotic
resistance becomes more and more difficult and complex, managing the appropriate use
of antibiotics in health care and agriculture is significantly important. We need to do this so that we can ensure effective
antibiotics will available when we need them. Meanwhile, new antibiotics, alternative therapies,
diagnostics, and preventive technologies, including vaccines, must be developed to help
reduce our dependence on our existing antibiotics and to combat those infections that are already
resistant. Vice Admiral Adams and I serve to protect
and promote the health of our nation, in part, by providing the best available scientific
information to the public. The participants in this meeting play a key
role in identifying, evaluating, and sharing that information, with the extensive and renowned
expertise held by each one of you, individually, including the diverse group of experts brought
to participate in meetings such as this one. I am truly, truly excited to see the terrific
collection of experts assembled here over the next two days. I look forward to hearing more about today’s
discussion, about the innovations and new therapies, diagnostics, vaccines, animal health
products, that will help lead us to a future of improved disease management and sustainable
food production. The critical topics discussed at this meeting,
all of which contribute to the infrastructure of our connected public health system, promise
to impact our ability to combat the spread of antibiotic resistance. I would like to thank each of the participants
for their contributions to these important discussions, and I commend all of you for
gathering such an influential and forward-thinking group, engaged in active problem solving in
a public forum. So, on that note, I would now like to recognize
four individuals who have made outstanding contributions to the field of antibiotic resistance. Through their work on the Presidential Advisory
Council on Combatting Antibiotic-Resistant Bacteria, these individuals have been central
to the fight against antibiotic resistance. With their recent retirement from the Council,
I would like to recognize their service and thank them for their dedication, contributions,
and tireless work on the Council. Thank you, all. So, the first person I’d like recognize is
Dr. Angela Caliendo. [applause] Thank you. Thank you. And the next person I would like to recognize
is Dr. Aileen Marty. [applause]>>Aileen Marty: Oh, my goodness. I got a salute.>>Erica Schwartz:
Congratulations. Thank you, so much. Twenty-five years in the Navy. [applause] And Miss Alicia Cole. [applause] [inaudible] [applause] I would also like to acknowledge Dr. Bob Weinstein,
who is not able to be with us today. I now have the distinct honor of introducing
the Associate Deputy Secretary at the Department of Health and Human Services, Mr. Charles
Keckler. [applause]>>Charles Keckler: Thank you so much, RADM
Schwartz. I also want to express the regrets of the
Dep. Sec., who had planned to be here this morning
was delayed by a weather event in South Dakota, keeping him fighting through the snow, a snowstorm
to get back here. It’s wonderful, RADM Schwartz, to have had
you here to represent the support of the SG of the United States Public Health Service,
who is the face of public health for this nation. I would also like to echo RADM Schwartz’s
appreciation and thanks for the retiring members of the PACCARB, and I’d like to thank everyone
involved in putting together today’s listening session, which is an important chance for
an update on the work to combat the threat of antimicrobial resistance. As all of you know, we have a global infectious
disease threat in the headlines today, the spread of the novel coronavirus, also known
as COVID-19. This has been a top priority and focus for
Sec. Azar, all of the HHS leadership, and the entire
Trump Administration since it began presenting a threat to the United States. The current coronavirus situation is a vitally
important reminder that we need to be constantly monitoring and preparing for new and challenging
infectious disease threats. We’re seeing, as we speak, the need for timely
detection and surveillance, effective treatments, and appropriate infection prevention and control
strategies in combatting infectious disease. Whatever differences people may have, this
is the common foe of all humanity. All of this demonstrates how seriously we
need to take threats like antimicrobial resistance. Addressing AMR will, like responding to COVID-19,
require coordination among many, many stakeholders. We have a tremendously broad range of partners
on AMR, including U.S. government agencies, foreign governments, international organizations,
and public and private stakeholders in healthcare, public health, agriculture, and other supporting
industries and sectors. Coordinating work across the public and private
sectors requires deliberate planning, and that is where the PACCARB and many parts of
HHS come in. Later this year, HHS will release an update
of the National Action Plan for Combatting Antibiotic-Resistant Bacteria, continue a
path forward for the U.S. government’s AMR efforts over the next five years. Many of the goals and objectives of our first
National Action Plan have been achieved, and this new iteration will build upon those successes
and identify new priorities and objectives going forward. Development of this new action plan was aided
by input from the PACCARB and other groups, with PACCARB providing input, advice, and
recommendations to the secretary last July, to inform direction of the government’s activities. The secretary, the deputy secretary, and I
all appreciate that these reports incorporated information gained through extensive engagement
with numerous experts across government and the private sector. Partnerships with the private sector are vital
to making progress on this issue, and I am glad to see extensive outreach to solicit
input from experts across disciplines and sectors. Meetings like this one today are an excellent
way to share information and bring outside viewpoints, making sure that discussions reflect
the current state of the field. It’s not just input, of course. We’ve also seen impressive results from when
HHS has issued calls to action from outside stakeholders, like the CDC’s AMR Challenge,
which delivered nearly 350 commitments from governments, MGO’s, pharmaceutical and biotech
companies, and other private sector businesses, to fight AMR, such as commitments to reduce
antibiotic use in animals. Past recommendations from the PACCARB have
emphasized the importance of forming public/private partnerships to support development of new
products for disease treatment, prevention, and control, build capacity for infection
prevention and antibiotic stewardship, and sharing data. We’ve seen some real successes in terms of
development of new antibiotics and diagnostic tests, as part of innovative public/private
partnerships, and that work must continue. In other words, while we face a daunting challenge
with AMR, we’ve also seen plenty of successes and we have plenty of reasons for hope. AMR will continue to remain a focus and a
priority for all of use across HHS, whether at OASH, CDC, ASPR, FDA, NIH, CMS, or elsewhere. It’s an all hands on deck task. Sec. Azar, Dep. Sec. Hargan, and I greatly appreciate the work
that those of you gathered here today are doing to fight AMR, and we look forward to
seeing you continue to develop innovative and novel ways to tackle this issue. So, thank you for that work, and I wish a
productive meeting today. And thank you, all, for having me here to
kick things off. [applause]>>Martin Blaser:
Thank you, Assoc. Dep. Sec. Keckler and RADM Schwartz for your words of
encouragement. We now will begin this meeting with a reminder
of how antibiotic-resistant infections affect real people. This morning we will have four advocates who
are visiting Capitol Hill as part of a program through the Pew Charitable Trust and have
taken time out of their schedules to address the Council. Welcome, all of you, and I’ll turn it over
to Dr. King to introduce the panel.>>Lonnie King:
Marty, thank you very much. It’s a pleasure to welcome all of you here
this morning, and it’s important that we start our two days with your session and patient
and stakeholder stories. So, let me introduce, first, Marshall Bartlett. Marshall Bartlett owns and operates Home Place
Pastures, in Como, MS, is committed to sustainable, ethical animal husbandry and the environmental
wellbeing of his community. I think it’s helpful in our One Health Platform
that we talk about. So, Marshall, welcome, and we look forward
to your comments.>>Marshall Bartlett: Thank you. I’d like to thank the Pew for the opportunity
to come up here and do this and to address all of y’all. Thank you for your time. So I, for all intents and purposes, am a hog
farmer in north Mississippi, and I’m here to talk today a little bit about my production
system and how it relates to this issue. And, basically, in north Mississippi, in Como,
Mississippi, where I’m from — I’m a fifth-generation farm. I moved back about six years ago to start
raising animals. So, a really unique aspect of our production
system is that we do not rely on antibiotics to produce these animals. Basically, the way that we mange and raise
them precedes the need to use these drugs. We allow the animals to exhibit their natural
social behaviors. We spread them out. We keep discrete groups of different populations
and maintain their sort of social pecking orders throughout their life cycle, and just
give them a lot of room and space, and, you know, what animals need to be happy. So, we also focus a lot on biosecurity, sterilizing
equipment, machinery, staff, changing clothing, boots between, you know, when traveling between
different populations of animals. And, basically, emphasizing a low-stress system. So, through doing that and through kind of
taking our farm in a new direction, I’ve been able to build a very viable business in this
rural community in north Mississippi, where there’s not a lot of economic activity happening. And we’ve been able to do that without using
these drugs to produce animals. So, another really important aspect of my
farm is that we constructed a federally inspected — or USDA inspected slaughter and processing
facility right in the middle of the farms. So we’re actually able to control our own
production, and then we market mostly to restaurants. But, you know, related to the antibiotic resistance
issue, there are a lot of producers out there like me, who either do not use these or drugs,
or, you know, want to use them responsibly, be good stewards of our antibiotics. I’ve been able to scale a business that does
not rely on them through better management practices, you know. But I also sell to a niche market of consumers
who are really interested in purchasing the products that — you know, we put the no antibiotics
ever claim on our label. However, we need help, and I think that’s
why I’m here. The USDA has been — obviously, you know,
from a regulatory standpoint, they oversee the plant, but all the subsidiary organizations
under the USDA that we have access to have been a huge boon to my business, allowed me
to create 16 jobs in a town of — I’m actually outside of town — of 1,000 people, and really
generate a lot of revenue in my state, which I’m so proud to do. But I’ve utilized microloans, grants through
the Rural Development Initiative, through the FSA, and then, you know, funding from
land-grant universities like Mississippi State. All of these resources have really helped
me design this unique production system that doesn’t rely on these drugs. And, just, you know, for some context, the
majority of the meat that we eat, you know, is raised sort of on a commodity scale. It’s very efficient, and it’s what we have
access to. But some of those production systems do rely
on antibiotics because the animals are in circumstances that make it necessary to sort
of preemptively medicate them on a daily basis. And that — those type of systems are very
successful at producing efficient, high quality meat. But there’s sort of a back story where that’s
a perfect environment for some of these resistance issues to start. So, you know, if you’re running a foodplant
and you’re farming this way, it’s very, you know, salient to me to see that these bugs,
you know, in these production systems can enter our food system. And that is pretty scary. So, we’re really proud to run a, you know,
a slaughter plant and a processing plant, and, on the farm side, to not be contributing
to this issue. But it’s definitely out there. So, we need, you know, producers like me and
need continued support for our systems to thrive. We can kind of decentralize the food system,
have these unique animal production systems that just rely on, sort of — this isn’t rocket
science stuff. I mean, a lot of it’s older practices that
farms are using now to kind of go back to focusing on the animal’s needs; low stress,
not using these drugs. And we need continued help from NRCS, from
the FSA, from Rural Development. All these initiatives through the USDA are
really, really critical for sort of this next generation of farmers that are interested
in combatting this issue to succeed by producing meat that doesn’t contribute to this issue
of antibiotic resistance. So, I’m just here to plead, to ask that you
all keep that in mind. I know it’s appropriations time up here. So, anyways, it’s very, very important that
farmers like myself have that support and that — continue funding to land-grant universities,
continue the research that’ll allow producers like me to continue producing meat in a, you
know, safe way that doesn’t contribute to this problem. So, thank you.>>Lonnie King: Mr. Bartlett, thank you very
much. We appreciate that. Now, I’d like to introduce Christina Fuhrman,
a patient advocate. Christina Fuhrman is a survivor of C. difficile,
works to increase awareness by connecting patients with resources. Welcome.>>Christina Fuhrman: Thank you. Thank you very much. When I was 31 and slowly dying in the hospital,
I never imagined I’d make it out of there, let alone be in front of you all. And I sincerely thank you all for your time
and for hearing my story. I, like countless other Americans, had an
antibiotic habit. Unwilling to be inconvenienced by any cold
or flu, I sought antibiotics as a magic pill for any pesky illness. And, sadly, my doctors prescribed them without
question. It is only with the knowledge that hindsight
delivers that I can see that the more antibiotics I took, the sicker I became. In 2012, I was — in 2012, I was hospitalized
with a C. diff infection. Having recently been engaged to be married,
my joy quickly turned to sorrow. I was completely blindsided by the debilitating
effects this bacterium had on my once healthy body. All antibiotic therapies to treat this infection
failed me, and I simply could not get better. I watched in horror as my face grew more gaunt,
my body more weak, and my life slipping away. What should have been the happiest time of
my life quickly became the saddest. Instead of shopping for a wedding dress, I
sat on a toilet and expelled parts of my intestines. It was degrading. I barely made it out of the hospital in time
to attend my own wedding, and my honeymoon to Sweden was instead spent, once again, in
isolation. At this point, I could literally feel my body
dying. Months and months passed. At the young age of 31, I had no longer anything
to offer. I felt like a liability. I couldn’t work. I couldn’t help others. I couldn’t even do the simplest things, like
eat food. It was only thanks to the fecal transplant
that I eventually recovered. A year after my recovery, I gave birth to
a healthy little girl, named Pearl. I decided from the very beginning I would
do my best to protect her from any superbugs. I had a natural birth. I breastfed her for 18 months, and I avoided
antibiotics. When she was 13 months old, I became pregnant
with our second child, Orin [phonetic sp]. Everything in life going very well, and we
were all very happy. But the superbug was not finished with our
family. Pearl’s intestines must have always been colonized
with C. diff spores, which can live for a very long time and are very hard to kill. And, sadly, she contracted a C. diff infection
at the young age of 22 months. Pearl was hospitalized in isolation, scared
to death of the machines around her and the doctors coming in when their — if they — in
their full gowns and masks. A little girl who couldn’t play or be a child
was on IV’s and unable to eat, just as I had been. Her condition was near critical. One night, as she lethargically lay on my
belly, our unborn son moved happily in my womb. I became paralyzed with fear of bringing another
child into this nightmare. A superbug was once again stealing the most
important days of our lives. Instead of joyfully preparing the house for
a new baby or showing my daughter the wonders of life, I sat, again, in a hospital with
her, watching her slip away. It was at that moment I could see the full
scope of the trouble we are all in. We have, right now, the perfect storm brewing
above us, gaining speed and strength. Our inappropriate and excessive antibiotic
use, the lack of incentive in developing new ones, and the weakening potency of our existing
antibiotics all add momentum to the storm, leaving lives devasted and lost in its wake. Pearl and I are the lucky ones because we
both survived and only because of the fecal transplant and alternative treatment. What if that hadn’t been there? Pearl and I are also here to debunk the myth
that these superbug infections only happen to the immune suppressed and the elderly. Since then — since her recovery, Pearl has
developed strep throat infections a couple of times. Each time I give her a dose of antibiotics,
her hazel eyes looking up at me in full trust, I both thank God that antibiotics do exist,
but I also pray for mercy for my children and for your children, because what is coming
is catastrophic if we cannot stop it. Thank you, so much for your time.>>Lonnie King: Miss Fuhrman, thank you very
much. Appreciate your comments. Now, I’d like to introduce Mary Millard. Mary Millard is a healthcare-associated infection
survivor and has become a public speaker to share her patient story and raise awareness.>>Mary Millard: Thank you. I do appreciate Pew bringing me out here today,
and it’s a big honor to speak with you all. I echo Christina’s plead about antibiotics. In fall of 2014, I was a very healthy adult,
had never had a prescription in my entire life, became a little bit ill with AFib, and
it was discovered that I had a large aortic root aneurysm and a partially collapsed valve,
which they deemed genetic because I had no other health issues. I was put in for surgery. The day before surgery, the valve collapsed
completely, and I coded. The code lasted six minutes. They couldn’t bring me back, so they tried
ECMO. And for those of you that don’t know what
that is, that is machinery that circulates and oxygenates your blood for you, and a machine
was beating my heart for me. Three to four days later, my heart came back
on its own. Two weeks later, I was strong enough to withstand
the surgery. So, I had the open-heart surgery. My husband had thought everything was well. This was already a month in the hospital. It’s something that I do not remember. I just know from my records and from what
doctors and my husband tell me. Five days later, he came in on a Sunday. I was due to go home, and he found me talking
in a confused manner and couldn’t hold my head up. And he notified a nurse, and the nurse said,
“Well, she must be having a stroke. She just had open-heart surgery.” After eight hours of a neural workup, a neurologist
put at the bottom of the note, “Could this be sepsis?” By that time, I was in acute septic shock. They had put me back into the ICU and I was
given a two percent chance to survive. What happened was, after the culture came
back, they had discovered pseudomonas aeruginosa. It’s a very rare pathogen for surgical site
infection. Most people with CF get this bug. I did not know, at the time, even being a
healthcare worker, really what this was. I had not paid attention to the crisis of
AMR. So, again, another 34 days in the hospital. I went home with a month of antibiotics, IV
infusions, and I am on lifetime antibiotics because the pseudomonas has set up housekeeping
on my graft, my artificial valve, my sternal wires, and all other hardware in my body. It is something that only three antibiotics
can suppress onto the biofilm and keep out of my bloodstream. There’s only three left and they rotate these. I was on Cipro for four and a half years,
1,500 milligrams a day. I had nerve damage. I wore boots. I had tendon damage. I had skin cancers because of the photosensitivity
that I had to have removed. I told my ID doctor I would rather die than
take another Cirpo. So now, I’m on IV therapy about once a month,
and we rotate Zosyn, tobramycin, and cefepime. And those are the only three right now that
will hold this down. Once these antibiotics become weak and this
bug comes back again, I don’t know what’s left. I’m not a good candidate for bacteriophage
therapy. So, I’m kind of lost. Four years ago, I was told this would get
me, but five and half years, I’m still here. And I beg of this council and of the government,
which I’m going to do tomorrow, to please, please, we need to have the push for new antibiotics,
not just repurposing old ones, but coming up with new things that will take on this
crisis. Since the five years ago, I have been re-hospitalized
12 times, been to the ER 47 times, I’ve had 22 CT scans, 130 x-rays, and six other surgical
procedures. It’s an ongoing nightmare, and it is something
that I thought would never happen to me. I was a healthy adult, and I was shocked to
learn the statistics on healthcare-acquired infections. I started doing research on it, and everybody
is going to know somebody that has one because it is getting worse and worse. And it is a current epidemic that we need
to address. I look forward to hearing about the work that
you’re doing. I think it’s very important. I think this is an important panel here. And I am looking forward to the day when nobody
has to go through this anymore because it has changed my life completely. I am no longer doing the work I was set to
do. But I feel that I have to advocate for people
who cannot speak up for themselves because so many people not only die of these infections,
but they also live with them. Thank you very much.>>Lonnie King: Mary, thank you very much
for that very important message. We appreciate it. I’d like to next introduce Chris Romm. Chris Romm lost his son Carl, and army veteran,
after an infection with vancomycin-resistant Staph aureus. He now shares his story to draw attention
to the threat of antibiotic resistance. Chris, we look forward to your comments.>>Chris Romm: Good morning. Thank you very much for the opportunity to
speak with you this morning and a huge thank you to Pew, as well, for the opportunity to
participate in all we do with them. My wife and I lost our firstborn child, Carl,
an army veteran. Came home from the army after medical discharge
because of an injury sustained while in the army, one week before he was scheduled to
be deployed to Afghanistan. He ended up having his trigger finger amputated,
and it became infected, after multiple grafts, with Staph aureus. He came home. He was never well. He ended up with multiple trips to the VA,
and everybody thought that he had the flu, a cold, bronchitis, and it was endless. He was on a good number of antibiotics for
a few months, on and off. And he just never felt right. And, then, on July 2nd, 2010 — was our anniversary
— my wife and I were going out for the evening, and our son didn’t feel well, and we finally
convinced him to go to the hospital. And we got him to our local hospital, which
is a great hospital, and he insisted that he could not go, but we pushed him through
the door. He was obviously scared. My wife and I went on our way for the evening. About an hour later we received a phone call
from the ER doctor telling us we needed to come back over to the hospital because our
son was critically ill. He was septic, multiple blood clots throughout
his bloodstream, and he had endocarditis, which they were treating. He was in the hospital multiple times. That time he survived. Thankfully, he was still very strong. He was in the hospital for about 10 days,
came home on IV therapy of antibiotics, multiple different antibiotics. Every time he came home from the hospital,
even though he was on IV therapy at home, he would immediately get sick because he wasn’t
on constant antibiotics. It was very, very strange. And I would end up taking him back to the
hospital multiple times in the middle of the night because he had severe chills and sweats
and everything that comes along with that. Second time, third time in the hospital, they
had him on the cardiac unit and he was in critical condition. The bacteria had destroyed his tricuspid valve,
and they needed to do surgery. But they couldn’t do it in Reno because he
had developed pulmonary hypertension along with a multitude of other issues. So, he was Care Flight’ed to Stanford, and,
thank God, they stabilized him at Stanford and were hopeful that they could do the surgery. They had considered, at one point, that he
needed a heart transplant because his heart was so badly damaged. He did end up having the valve replaced and
a couple of other repairs to his heart, very successful. He actually got better in Stanford, and when
he came home — and the perniciousness the bacteria — by the time I drove him home from
Stanford — we got halfway home to the Reno area, he had been off of antibiotics for four
hours, and he was suffering from chills and sweats in the car on the way home. We went to the doctor immediately, back in
the hospital. Two more trips to the hospital. Carl was on every antibiotic that they could
throw at him, including vancomycin. And he would get better, he would get worse. It was a very up and down situation. He’d be critical. He’d be better back at the hospital; critical. And it was terrifying for our family. On the day that he was scheduled to be released
from the hospital, he was finally somewhat better. He was going to come home on IV antibiotics
again. And I went to the hospital that morning, the
morning that he was scheduled to be released, and he was in the bathroom. And I figured that he was taking a shower. This went on a little too long, and finally
I knocked on the door, and no answer. So, I went in, and I found him unconscious
on the floor, and he was in cardiac arrest. I guess I went into survival mode. I drug him out of the bathroom, calling for
help, and I started CPR on my own son, terrified because he’d just recently had open-heart
surgery, and I knew that I was going to break his ribs. And that terrified me. I can’t begin to tell you how terrifying that
is. Immediately, everybody came in. They came in and moved me off to the side,
and they started working on our son. And I emphasize this point because this can
happen to any of you, any of us, anybody in this country or around the world. It’s terrifying. And they moved me out of the way and asked
me to step outside, and they had a chaplain there already. It was — I — it was grace filled from that
moment. I don’t know how else to put it. I pulled out my cellphone, and I called my
wife, and I asked her to please come to the hospital, that the doctors wanted to speak
with us, that Carl was not doing well. And she was dropping our 3-year-old granddaughter
off at preschool. And she was on her way to the hospital. She didn’t catch on the fourth time I called
her and asked her where she was, either. And I say this too because, when she finally
got there and coming up the elevator — I was standing outside the elevator — I knew
what I was going to have to tell my wife when she stepped off that elevator, and our whole
lives flashed before my eyes. I knew the past, I relived the past, and I
knew what the future was going to hold, all in this brief moment of time. And I don’t want that to happen to anybody. I told my wife that our son was gone. The wail and the scream of a mother who has
lost her child is terrifying. It’s heart-wrenching. It was bad enough for me. But I cannot begin to tell you how many other
people this happens to. We know too many people that this has happened
to. I know I’ve gone over my time. I apologize. We ask for your support, to the administration,
to direct more and more funding in this most critical area. The next time this happens, it could be someone
you know, someone you love. And it — this is a devasting thing to happen
to people, just as any other illness is. But I don’t want anybody else doing CPR on
their own child or hearing their wife wail and scream because they have lost their child. Thank you very much.>>Lonnie King: Let me thank all of your for
sharing your stories. They’re powerful. They’re sobering. They certainly ground us and are an important
reminder to all of us of the work that we have done, but, probably more importantly,
the work we are yet to do. So, thank you. I think let’s spend a few minutes on reflection
and probably some questions or comments from the panel. Alicia, do you want to start?>>Alicia Cole: Hi. Alicia Cole. I know some of you, and I just want to thank
you for being here this morning. As a fellow survivor, I know it’s not easy
to relive that and to share it. And we just thank you that you are here, and
you are willing to share your stories in an effort to help other people understand what
it’s like. And I think there’s a great common thread
that goes through all of your stories and its prevention is key. Because you’re at the precipice of running
out of workable antibiotics. And, so, we’ve got to make sure that, while
we’re looking to the future, you’ve been a great reminder that we have to be also focused
on prevention, because, as each of your stories has shown, infections are the gift that keep
on giving. You know, multiple follow up surgeries and
procedures, multiple treatments, aftercare. And that’s the part that a lot of healthcare
providers don’t see once you leave their facility. You’re written off as a great outcome. You survived, and then you are sent home to
then recreate a new life. And, in the committee, we talk a lot about
data and science, but going forward, I’d just like to — in the work that the committee
does from this point forward — and you have as well, in the past — in our talks of data
and statistics and science, to remember that numerators are people. Numerators are people. And, so, that we keep a sense of urgency and
we keep a sense of putting the patient and the public first in all that we do going forward. And thank you, so much, for that.>>Lonnie King: Okay. Locke and then Marty.>>Locke Karriker: Hello. Locke Karriker from Iowa State. I want to thank everybody on the panel for
those very personal stories, and I think they illustrate the granularity of the — and the
impact of the issues that we discuss sometimes at a very — at an 80 thousand foot view,
so to speak. I have a question, more specifically, for
Mr. Marshall, if you don’t mind. And I’m curious if you’d comment on the challenges
that you face in scaling up your production approach to replace a significant portion
of the commodity type production that you referenced. What are the impediments to that or the challenges
that you see, and what resources would be required?>>Marshall Bartlett: So, I got, like, six
hours to answer your question [laughs], because there are many of them. But, you know, I think the challenge in our
greater food system, sort of from that higher up level, is that producers like me, at the
end of the day, we are a niche market. And, I mean, I represent a very small percentage
of the meat being produced and sold even in my state. However, I have been able, kind of through
building this facility where I’m able to slaughter and process under federal inspection — that
facility is one of only three in the entire state of Mississippi. So, it gives you an idea of the tremendous
bottleneck that the slaughter and processing has with the meat industry. But by taking control of that, I’ve been able
to add a bunch of jobs in my community and scale up my production and reach a greater
market. So, right now, I’m servicing about 100 restaurants,
from New Orleans to Nashville, and sort of everywhere in between. Chefs are our main customers that want this
type of product, but we’re growing to individual consumers. So, it is a challenge because our product
is — you know, to produce it costs more. Efficiency is not our bottom line, it’s the
wellbeing of our animals and our customers. So, right there, you’re kind of pricing out
some of the people that need this product the most, and that is a tremendous challenge. And I’m not really sure what the answer is
other than continuing to support producers who are good stewards of antibiotics, continue
research, continue developing practices that don’t rely on these drugs, so that we can
all create a better food system together. And, to me, you know, from my personal perspective,
it is really, really important to keep these low-interest loans available, these NRCS EQIP
grants. I’m a receiver of the Value-Added Producer
Grant through the Rural Development Program of the USDA. I’m — this is the third one I’ve gotten. That has helped me grow tremendously. We’ve got to support entrepreneurial farmers
that are going into these new production systems, not only for the health and safety of our
food and to combat this issue, but also to revitalize and sustain our rural economies. The centralization of the food system in America
has made a lot of really cheap food, makes cheap protein, got to feed the world. That’s really important, but it’s also removed
and extracted a lot of resources from our rural ag economies. And I’m trying to reverse that flow and it
is tremendously difficult. So, any help we can get, we need. Martin Blaser: I’d also like to join in to
thank everyone for coming here today, especially for our patient advocates for sharing your
terrible and difficult stories. And I’m personally very grateful that you’ve
— that you want to get the silver lining from these clouds, to try to, to try to make
it a better world. So, I want to particularly ask Miss Fuhrman
a question because you highlight something that’s really important, and that is that
antibiotics are both the heroes and the villains.>>Christina Fuhrman: Yes.>>Martin Blaser: They’re the heroes — we
need antibiotics that work, but in your case, you could see what it did to you and the harm
from it. And, in part, that’s the paradox that we’re
all grappling with because, as you said, you were addicted to antibiotics, and, so, in
fact, is our whole society. And, in fact, so is most of the world, not
just in the United States. So, when you, when you tell your stories about
how you were overusing antibiotics, what do the people say when you talk to them.>>Christina Fuhrman: And I agree, this is
such a complex topic, and how do we solve it? But when I — when I speak to others — and
I share my story locally and nationally as much as I can because my goal is to teach
the regular people like me, who have this antibiotic habit — it’s everybody, really. Most people. And I find that they’re always shocked. They’re always shocked that antibiotics could
have any kind of side effects, that they alter your gut microbiome to the, to the fact that
you can become sicker later, and prolonged antibiotic use can cause many chronic illnesses. They’re shocked. And, so, I think that it’s really important
that we educate as many people as we can, because I also speak with a lot of doctors
and they feel a lot pf pressure from patients, especially pediatric patients that come in. They want an antibiotic for their children. So, I work with them as well. And, so, I think that it’s education for — on
every, on every spectrum. And that’s my goal, is to educate just the
general public that you need to be your own advocate, and also just understand that your
body is a little bit stronger than you think, and you don’t need a pill for everything. And, so, that’s my goal to do. But it is — it is humbling to see how much
work needs to be done. But I’m so encouraged by everyone here. This is just remarkable. So, thank you.>>Lonnie King: [inaudible] Thank you very
much. We really appreciate it. So, we’re just a couple minutes early, so
I think we’ll go ahead and move to our next panel, and we’ll invite Dr. Helen Boucher
to moderate that panel.>>Helen Boucher: Thank you so much, Dr. King. Good morning, everybody. We’re really happy to begin our panels today
with the discussion of antibiotic stewardship and its relationship to fostering a sustainable
marketplace for the development of new antibiotics and other therapies for antibiotic-resistant
infections. We’re all well aware of the importance of
antibiotic stewardship and limiting the inappropriate use of antibiotics, as we just heard so beautifully
stated by our patient advocates. Meanwhile, many people have realized, and
some have raised concerns that our need to preserve the precious resources of antibiotics
may result in diminished antimicrobial market, removing incentives for companies to develop
new products. And this panel will explore how stewardship
can have a role in innovation and look at some possible solutions for supporting innovation,
including perspectives from both small companies and large companies who are developing antibiotics. So, it’s really my pleasure to introduce my
colleague, Dr. Sara Cosgrove, Professor of Medicine and Epidemiology at Johns Hopkins
and Director of the Department of Antimicrobial Stewardship at Johns Hopkins, to talk to us
about the role of stewardship and optimizing the use of new agents. Sara.>>Sara Cosgrove: Thank you, Dr. Boucher. It’s really my pleasure to speak today. If you’ve ever heard me talk at PACCARB, you
know I’m a huge advocate for antibiotic stewardship. And, in that sense, it’s been a little dismaying
to me and certainly other stewardship colleagues to see news articles that basically imply
that stewardship is part of the problem with, you know, making and using new antibiotics,
rather than part of the solution. So, most of my comments today are to set forth
what the issues are and how I think that we should all be working together to use new
antibiotics in the best possible way. And the danger of kind of blaming stewardship
for the problems are that the problems are way, way bigger than stewardship, as to why
we have problems in the antibiotic pipeline. And, so, it almost is kind of a bad thing
to focus on. It kind of wastes our time, to some degree,
to not focus on the bigger issues. Here are my disclosures, and I think I’ve
told you what my objectives are. So, let’s start with this graph. And this is a graph that basically shows in,
in blue, the use of polymyxins, the antibiotics we used to have as our only agents for many
of the resistant gram-negative organisms, and in green, an amalgam of the newer antibiotics,
mainly the beta-lactam and beta-lactamase inhibitor combinations, and the use over a
two year period, 2016 to 2017, in 576 hospitals across the country. And I’ll just note that two of these agents
were approved in 2014 and 2015, and this graph doesn’t even start until 2016. And what you see is that, for most of 2016
and ’17, there was still more use of the colistin and polymyxin type antibiotics across the
country than these new antibiotics, which are better. Colistin is not a good drug. We were using it out of desperation, and the
new antibiotics work better against these infections. So, what’s the deal? Why is it that it took so long from the approval
of these drugs for them to be used more, at least a little bit more, than the polymyxin
class of antibiotics? So, just in response to this issue of it’s
all because of stewardship that people weren’t using the antibiotics, I will point in this
survey that was published about a year ago, that shows that recommendations, at least
in — amongst 110 pharmacists in 41 states, really asked physicians to use these drugs. So, over 80 percent of the recommendations
in these hospitals for carbapenem-resistant infections were to use ceftaz-avi or meropenem-vaborbactam,
and the numbers of institutions that were using polymyxins in their guidelines for the
treatment of these infections was incredibly low. It was four percent, a little higher for urinary
tract infections, sometimes for aminoglycosides. But, in general, these hospitals were saying,
“Use these drugs.” So, what’s the problem? So, we�ve talked before at PACCARB, and
certainly this has been a big topic of discussions at FDA, that the primary studies to support
approval of these agents are noninferiority studies in patients without resistant organisms. So, the data we have when the drugs go to
market are on, not the infections that we’re interested in using the drugs for. That doesn’t mean this isn’t important. We need to use normal processes to get drugs
approved. But it’s kind of a fact of life. We don’t want to just approve drugs on the
basis of a small number of patients with resistant organisms. We want good, robust data about the safety
of these agents. There’s also almost never patients with the
actual resistant organisms in any of these studies. Companies are certainly allowed to present
smaller studies that have been done in patients with resistant organisms as part of their
approval package, and many do this. But, just on this table here, you can see
that these numbers are less than 50. There are very small numbers of patients that
have had these drugs tested who have resistant organisms. Now, I will point out, we don’t want to live
in a world where we have an abundance of resistant organisms to facilitate enrollment in trials
of new antibiotics. We really actually should be happy that we
don’t have a lot of these patients to enroll in trials. But when you, as a clinician, are faced with
how to treat the patients, when the drugs first come out, you don’t have a lot of information
about how they will behave and whether they will work in patients with actual resistant
infections. We do know how bad colistin is because of
post-approval studies that have been done. And these studies are absolutely critical. We have to move the science forward to know
how and when to use the new agents and can’t just rely on the studies done for FDA approval. It is certainly true that the new agents are
more expensive, and that is a driver in many hospitals to not a rapidly switch over to
these new agents and historically there have also been difficulties with susceptibility
testing, so that’s really rough if you can’t test and see if the drug is susceptible. It’s kind of hard to use it in a patient with
a resistant organism. That has improved, which is fantastic, but
we must keep an eye on it. So, what about stewardship programs? So I would argue that stewardship programs
are actually critical and getting these drugs used because they’re often primary drivers
of formulary edition of new agents, they often coordinate these issues of how are we going
to test it in the micro lab, how are we going to position it and use it in the hospital,
how are we going to know how long to use it for and many of these routine issues that
stewardship programs are involved with. And then further dosing is a big issue with
these agents. In fact, sometimes the initial approval is
for a syndrome that doesn’t require a high dose, but we want to use it for a syndrome
that does require a high dose. Stewardship programs can really help making
sure we dose these agents optimally in patients as we learn more about how to use them. Further, stewardship programs make a business
of worrying about emergence of resistance, and these organisms are smart and wily, and
our new drugs only last for so long against these resistant organisms, and we worry — all
of us — about emergence of resistance across the population, but in the hospital, we worry
a lot about what happens to an individual patient who’s being treated with an antibiotic. So we think a lot about this and, for that
reason, often are concerned about the idea of the newer agents using — being used routinely
for empiric therapy because use of agents for empiric therapy across the board just
to increase the use of them leads to resistance. There’s certainly some baseline resistance
with the new antibiotics. We also know that there are differences in
resistance based on the patient population. So, this data in this table compare resistance
in ceftolozane/tazobactam in patients with cystic fibrosis and patients without cystic
fibrosis. So even in our own hospital, if you are a
patient with cystic fibrosis, you’re a lot more likely to have resistance to this new
agent to treat pseudomonas then you are if you don’t have cystic fibrosis. So, we can’t even predict, you know, is this
drug into work or not, that’s why susceptibility testing is so important. And further, we’ve already seen a fair amount
of emergence of resistance to the new agents, at least in publications. These two here; the first one is for ceftazidime-avibactam,
and in patients who had microbiologic failure in this case report, there was resistance
developing in three of 10 patients, so it is not insignificant and fairly similar with
ceftolozane/tazobactam for pseudomonas. In this, patients who had micro failure had
resistance in six out of 10 of the failures, so a lot of resistance. This matters because these are our last resort
agents, and often we’re using them in patients that were trying to get somewhere else medically. A patient who we’re trying to get to a liver
transplant, a patient who we’re trying to get to a lung transplant. And so flagrant use of them impacts those
patients directly, because we want to preserve them for those patients so that they can get
over that hump of getting to transplant, of getting to the procedure that they need, and
that’s why stewardship programs are there to say wait, should we use it now or should
we use it later? And that’s a sad case to be in, but at the
individual patient level, sometimes we have to temporize and then get that patient to
the procedure and treat them definitively after they get the procedure, and it’s a fact
of life in medicine unfortunately. Other challenges for these agents are that
they, as I mentioned, are expensive and even if we use them in the hospital, sometimes
there’s a lot of difficulty in getting them for patients after the patients leave the
hospital. Insurance will sometimes balk, especially
if there is being used for non-FDA indication, leading to lots of phone calls and pleading
and often not getting what you want. And the nursing homes that we often have to
send our sicker patients to often don’t have the agent, don’t have access to the agent,
and also complain about the cost of the agent. And changes to the inpatient prospective payment
system don’t necessarily address these issues once the patient leaves the hospital. I’ve talked mainly about agents that we are
using for resistant organisms and I do think it’s important to comment briefly on a variety
of antibiotics that have recently been approved, that don’t clearly have an indication for
highly resistant gram-negative organisms. These agents have been studied for syndromes
that we have a lot of antibiotics for already, like community-acquired pneumonia, and they
cost 10 to 25 times more than standard therapy. And so, it really is hard to justify preferential
use of these agents in hospitalized patients for these indications that they’ve been approved
for. I do, however, want to put in a word for the
notion that we should never abandon new antibiotics because we don’t know what they’re going to
be useful for in the future. Most of us when fluoroquinolones were first
approved, were not thinking about using them in tuberculosis, the same for linezolid, and
now these are drugs that are important in treatment of tuberculosis. So, what about — of these three antibiotics
I have listed here is the future, and if we let them go away, we’ll never have that chance
to understand what they may be useful for in the future. So, what can we do to ensure optimal use of
new agents? I do think we need better education of ID
specialists, intensivists, other people at the front line who care for patients with
these resistant organisms, about when to use the new agents and about the issues with polymyxins
not being preferred drugs. We need to continue, as I mentioned, to push
forward with post-approval studies, post-approval data on resistant organisms and the use of
these drugs, we need new study designs, we need to move faster to get this information
out to people using the drugs. We can’t have five-year-long trials to figure
out where the positioning of the new drugs needs to be. We also need to get better, as we’ve talked
in this group many times, about predicting who the patients are. Who should get empiric treatment with these
agents? We don’t want to treat every patient in the
hospital empirically with these agents, but if we knew they were at high risk for a resistant
organism, if we knew early that their blood cultures are growing a resistant organism,
we could do better. We could use these agents more effectively
in patients who need them. Just of note, we have had a little boost from
our friends at CLSI who have now changed break points for colistin and polymyxin B, so that
virtually no organism is now susceptible to any of these agents. And, you know, so they’re not, and they are
not very good drugs, and so that is actually quite helpful, and so clinicians now will
not be seeing that there’s susceptibility to these agents anymore. And finally, as I mentioned, we must make
sure that we have susceptibility testing available. And I’ll just note that right on Friday, I
think, we learned that ceftazidime-avibactam is having a production problem, and this is
really not good news, so there is not a pipeline right now of having this drug available to
us in the hospital. We’ve been asked to conserve the drug, so
I’ll just say right at the very end, we must make sure that we have the ability to make
these drugs so that we can deliver them to our patients.>>Helen Boucher: Thank you very much, Dr.
Cosgrove. We’re going to move through the talks and
then have time for questions at the end. So now, we’ll turn our attention to the phone
where we are really grateful that Dr. Fatema Rafiqi, the Research Program Manager at the
Access to Medicine Foundation, is joining us to talk about antimicrobial resistance
benchmarks, a report from the World Economic Forum, and I think it speaks to the importance
of this problem that AMR was ectopic of the World Economic Forum. So welcome, Dr. Rafiqi.>>Fatema Rafiqi: Good morning everyone, so
as mentioned, today I’ll on the recent report by the Access to Medicine Foundation, the
2020 Antimicrobial Resistance Benchmark, as well as, on the reception of the report at
the 2020 World Economic Forum. Next slide. On January 21st, 2020, the Access to Medicine
Foundation launched the second iteration of the AMR benchmark. This report gives a reality check on the biggest
players in the anti-infectives market and how they’re responding to drug resistance
and access challenges. Are these companies resilient enough for the
tough market conditions? The launch of the report, including highlights
of the key findings, have been covered by many news outlets and scientific press including
Bloomberg, The Guardian, The Financial Times, and others. Next slide. Following the launch of the 2020 AMR Benchmark
on January 23rd, the results of our analysis were first presented in a dedicated session
at the WEF Annual Meeting in Davos. The session was titled “Securing the Future
of Healthcare Through Access to New and Essential Antibiotics: the 20/20 AMR Benchmark,” and
the discussion focused on revitalizing the infrastructure for developing and deploying
antibiotics to reach more patients around the world. Next slide, please. The Access to Medicine Foundation is an independent
nonprofit organization based in Amsterdam, the Netherlands, and we receive no funding
from the pharmaceutical industry. We are funded by the Dutch and British governments,
as well as, the Gates Foundation. It is our mission to stimulate and guide pharmaceutical
companies to do more for people living in low and middle-income countries without access
to medicine. Specifically, we guide and incentivize pharmaceutical
companies to two more to improve access to medicine by conducting research on what companies
do, by comparing their performance against one another, and by identifying best practices
and areas for improvement. Next slide, please. Drug resistance or antimicrobial resistance
is on the increase and it can spread fast. As part of the global community, the role
for the pharmaceutical companies is to responsibly bring us safe and effective antimicrobials,
however, the anti-infectives market is widely acknowledged to be challenging and commercially
unattractive, with little incentive to develop new antimicrobials. The AMR Benchmark is a tool that measures
what pharmaceutical companies are doing to limit the rise of AMR resistance. Next slide, please. In 2020, we have focused on a review of the
activities of the 30 pharmaceutical companies considered to be the biggest players in the
field, including those with the largest R&D divisions, has the largest market presence,
and those with the leading expertise in developing critically needed antibiotics and antifungals. These are among the last companies that remain
invested in keeping critically needed medicines and vaccines available and developing new
ones. Among the 30 companies evaluated, we assessed
that they have more than 1,500 antibacterial or antifungal medicines or vaccines on the
market. Next slide, please. As mentioned previously, the AMR Benchmark
guides and incentivizes companies to do more by measuring their performance in critical
areas for action. The Benchmark employees an analytical framework
of 19 indicators organized into three research areas. These three research areas include research
and development, responsible manufacturing, and appropriate access in stewardship. The R&D research area maps the R&D activities
that Target priority bacterial and fungal pathogens posing significant threats due to
AMR. The responsible manufacturing research area
compares company strategies for limiting the environmental impact of antibacterial manufacturing
on resistance. And finally, the appropriate access in stewardship
research areas assesses company strategies for antibacterial and antifungal medicines
and vaccines for the 102 countries where greater access is most needed, alongside their global
stewardship initiative. Next slide, please. So, the Benchmark report provides several
highlights. Next slide, please. At a glance, in the report, we provide our
findings within the three research areas previously mentioned. We report four key findings; two of these
key findings are within the stewardship research area, as well as, 12 best practices. We also conducted a pipeline analysis looking
into which companies are developing new treatments for the most threatening bacteria and fungi,
and also a portfolio analysis looking into which companies are producing important antibacterial
and antifungal products from a public health perspective. We also assured that each company received
a detailed report card that performs — that reports on company-specific performance. Next slide, please. So overall, the 2020 Benchmark finds that
there are signs of improvement on how pharmaceutical companies are tackling AMR, but the pace of
change does not match the scale of the AMR challenge. Here, for each company, the overall ranking,
the white space indicates the room for companies to improve overall. Next slide, please. Among our four key findings, we noted that
there are signs of movement in accessing stewardship planning for late-stage projects in R&D. There is progress in how pharmaceutical companies
are tackling the overselling of antimicrobials with 10 companies reporting that they’re either
decoupling bonuses from salesmen — sales volume or refraining from deploying sales
agents for antibacterials. And while public sharing of AMR results is
common practice, only one company shares its raw data. Next slide, please. It was mentioned at the start of the talk,
the 2020 AMR Benchmark was launched during an affiliated session of the WEF Annual Meeting,
followed by a high panel — high-level panel discussion. The Benchmark is funded by the Dutch and U.K.
government, and the session was opened by Bruno Bruins, the Minister of the Medical
Care for the Netherlands, and moderated by Dame Sally Davies, the U.K. special envoy
on AMR and the co-convener of the U.K. — of the U.N. Interagency Coordination Group on
AMR. The agenda for the session focused on revitalizing
the infrastructure for developing and deploying antibiotics to reach more patients around
the world. The central question during the session with
how to motivate pharmaceutical companies to do more to curb AMR. A reoccurring theme during the panel discussion
with the urgent need to improve access to antibiotics, in particular, to child-friendly
formulations of antibiotics for children living in low and middle-income countries, where
better access to antibiotics would have prevented many of the 6.3 million deaths among children
under the age of five. There was much discussion on using both the
carrot and the stick in terms of push and pull incentives, as well as, the model — the
economic model piloted by the U.K. government since July 2019 known as the Netflix or subscription
model, where they focus on value over volume and pay for antibiotics with contractual subscriptions
for antibiotics supply, rather than by the volume of drugs sold. Here during the session, The Benchmark was
highlighted as a useful tool for all global health stakeholders interested in partnering
with the private sector. Specifically, key highlights from the discussion,
we were able to garner interest from procurers who will be able to use the Benchmark as a
tool to inform decisions about company and product selection for their program. Specifically, we heard from Peter Sands, the
Executive Director of the Global Fund to Fight AIDS, Tuberculosis, and Malaria. The Global Fund is one of the biggest purchasers
of antimicrobials in the world and will look to the AMR Benchmark results to explore how
company performance can inform procurement decisions. The session was also used at the moment to
announce the Investor Europe Action on AMR, a new collaboration to mobilize investors
in the fight against the AMR, and this is a collaboration between the U.K. government,
the Access to Medicine Foundation, the FAIRR Initiative, and the Principles for Responsible
Investment. And the aim here is to encourage and guide
investors to use an “AMR lens,” when making decisions and engaging with companies. And I end my discussion there.>>Helen Boucher: Thank you very much, Dr.
Rafiqi.>>Female Speaker: Produced by the U.S Department
of Health and Human Services at taxpayer expense.