PACCARB 11th Public Mtg, Day 2 Pt 2: PANEL 6: Consumer Impact on Antibiotic Use


>>Michael Apley: Welcome, everyone, to our
second panel of the day. I would like to welcome our panelists; Dr. Jay Graham, Bruce Feinberg,
Dr. Jeffrey Gerber, and Harshika Sarbajna. Thank you all for coming. And without further ado, we will start with
Dr. Graham, and welcome.>>Jay Graham: Thank you. Thank you for having
me. I’ll be talking about antimicrobial use in small-scale food animal production with
sort of a focus in low- and middle-income countries. Next slide. So just to sort of give you some background;
in 2012, it was estimated that there are 24 billion domesticated animals, and much of
this, even though this is not necessarily the case in the U.S., occurs in small-scale
production operations. So — and we — it’s estimated that there are about 500 million
small — or households that conduct small-scale food animal production which mainly occurs
in the back — you know, in the household environment. Many organizations are promoting this effort,
so you have Gates Foundation, Heifer International; several are promoting this to improve livelihoods
and also the nutrition of children. And given the large number of people that interact with
this type of activity, my concerns have been on the public health side; so what are some
of the health risks that are associated with small-scale food animal production? Next slide. So in 2011, our research group received funding
from NIH to look at zoonotic enteric pathogen transmission. So we were looking mainly at
pathogens to see whether there was movement between the small-scale livestock and children,
in the household environment, and so we conducted surveys. We also took fecal samples from the
children and also fecal samples from the animals, and we started looking at pathogen transmission.
At the same time, we began to notice that there was an incredible number of sales shops
veterinary sales shops that were selling antibiotics over the counter. And so we also looked at
commensal E. coli from the fecal samples from children and animals, and so we did a small
study just to look at 64 children and their livestock in their household environment. And one of the things that we noticed is,
you know, after we looked at these commensal E. coli — these were grown on nonselective
media plates so we did not select for the highly drug-resistant organisms — but we
noticed that about a third — over a third were multi-drug resistant, so resistant to
more than three classes of drugs. And that there was — and then when we actually genotyped
the organisms, we realized that they had no relationship to each other. They were different
organisms, different types of E. coli. But when we began to look at the plasma NTs and
mobile genetic elements, they overlapped significantly. You can see many of the — the resistance
genes are shared and many of the mobile genetic elements, which we’re analyzing now, do overlap.
So we’re finding that you might not find the same isolate, genetically speaking, but you
do find a lot of the mobile genetic elements that move the resistance genes to be the same.
Next slide. At the same time, we started conducting qualitative
research to better understand knowledge, perceptions, practices around antimicrobial use and understanding
of antimicrobial resistance. So we worked with a sociologist in Ecuador to try to understand
how people are using antimicrobials, why they’re using them. And when we talked to the small-scale
food animal producers, nearly half of them that were interviewed reported that they felt
that antibiotics were essential for growth promotion purposes, so not just keeping their
animals healthy, though healthy animals was an also — was a topic that was also mentioned.
And within our small study area which is probably three to four square miles, we found over
80 veterinary shops that were selling these drugs over the counter. So — and then when
we — you know, in the conversations with the producers, many had limited understanding
of antibiotic resistance. Only a few had actually heard of the term, and they often confused
vitamins and antibiotics, so we had to really dig in deep to really understand antibiotic
use in that community. Next slide. So this is a quote, from one of the producers,
that represents many of the sentiments that exist among this population. This summer,
we will be going to many of those shops to do a secret shopper analysis, where we’re
going to look and see; what are the recommendations that these sales agents make? So when you
show up and you provide a scenario, what do they actually recommend in terms of antibiotics?
We’re going to also do in-depth interviews with the sales agents, some of them are veterinarians
and some of them are not, and try to understand what they’re prescribing based on different
scenarios that the producers come in with. And we’re also going to dig in deeper to understand;
what are the decisions — or what are the drivers for decision-making, in terms of the
small-scale producers, to better understand what — where we can interview and design
programs? Next slide. So in summary, antibiotics are readily available
for small-scale livestock and poultry producers. There’s a lack — there appears to be a lack
of veterinary capacity. Many people are relying on their own personal knowledge or the knowledge
of sales agents, many who are not veterinarians. Small-scale production occurs in the household
environment. Sometimes people will actually let the animals into their home because they’re
afraid that they may be stolen at night, because this is such an important economic component
of their life and important to their livelihood. So spillover, in this situation of antibiotic
resistance, is highly likely. And so I mentioned that the decisions are often made based on
household economics and there — there’s not a lot of concern about societal problems associated
with resistance. So we’ll be looking at this — these questions more to really understand
what kind of interventions can be designed for these types of settings. Next slide. So my recommendations would be; one, I think
we don’t have a strong understanding of community-acquired antibiotic resistance. I think there are a
number of ways where we could — we could look at this question, especially in areas
where we think there’s a lot more risk, so areas where surface water, especially contaminated
surface water, is being used to irrigate edible crops, many of them that are eaten raw. I
think that — I’d say the second point here is probably the point I would like to emphasize
the most, which is developing models that — for low and middle-income countries. And
so I think, you know, what’s relevant for Ecuador in this case may not be relevant for
other countries. So we heard some situations in sub-Saharan and African countries might
be very different; so really unpacking what interventions at different levels, so low-income
countries; very different context than lower middle-income, than upper middle-income. Like,
Ecuador is an upper middle-income country. So there may be times when the option would
be to focus on prescription-only legislation. In India, recently, they’ve stopped — they’ve
banned — made a — at least passed legislation to ban colistin — the use of colistin. Ecuador
now is discussing that. So there are going to be times when we have to use, I think,
heavy-handed interventions, such as potentially banning certain chemicals, but in other cases,
I think there’s going to be collaborative and informal regulation. There’s also going
to be professional bodies; veterinary societies, for example, that can help more gently move
the practice of antimicrobial stewardship, and then look at incentives for changing antimicrobial
use. So I believe that’s — yeah, I think that’s
all I really wanted to focus on. Thank you. Next slide.
I just want to thank, of course, the funders and many collaborators, and thank you again
for having me.>>Michael Apley: Thank you, Dr. Graham. I
anticipate a lively discussion and questions from our group. Next is Bruce Feinberg from
McDonald’s to talk about the initiatives his company is undertaking. Bruce, welcome.>>Bruce Feinberg: Good morning, and thank
you again for the opportunity to be here today. My name is Bruce Feinberg, and I’m a Senior
Director for McDonald’s Corporation, Global Quality Systems. I’m privileged to lead a
team of highly committed professionals that focus on partnering with our global network
of protein suppliers — those that provide our restaurants the beef, the chicken, the
fish, pork, and dairy products — primarily focusing on continuous improvement that ensures
both the quality as well as the safety of the food that we serve our customers at restaurant
every day. Beyond our commitment to safe and consistent
quality ingredients, I’m personally responsible for leading the development of global policy
for the corporation, covering a wide scope of topics related to animal health and welfare.
I’m proud to have recently celebrated my 20th year with McDonald’s this past year, and so
thankful to have had the opportunity to collaborate with folks that have certainly forgotten more
than I’ll ever know. A sustainable agricultural community, inclusive of responsible antibiotic
use, that improves the health and welfare of those animals in our supply chain, that
are issues that I’m very passionate about, and I’m proud to represent McDonald’s today
to share recent efforts as a global restaurant company. Next slide, please. I’m certain that you’ve heard of us, but allow
me to share a few facts that demonstrates McDonald’s scale. McDonald’s is the world’s
leading global food service retailer with over 37,000 locations. We’re privileged to
do business in more than 120 countries around the world, and proud to serve more than 64
million customers every day. This is a huge responsibility and one that we take extremely
seriously, as our customers, for over six decades, have come to trust McDonald’s to
serve safe food, great-tasting food and beverages, in a safe environment, and to further demonstrate
corporate responsibility by being better not just bigger. Next slide, please. We believe that delicious food can be sustainable
for customers, producers, and the environment, and we’re working to make this vision a reality.
As a global restaurant company operating a world-class supply chain, we know that even
small changes can result in big impacts. We embrace the responsibility that comes with
this scale. We call it “Using our Scale for Good.” McDonald’s recognizes, too; antibiotic
resistance is a critical public health issue that we take seriously, and use our unique
position as a significant purchaser in the market place where we do business, and of
course the unique relationships we have with industry, to address this challenge. Next
slide, please. McDonald’s is committed to positively impacting
issues important to people, animals, and the planet. In line with this commitment, our
focus on antibiotic use is not new news, as we developed our first guidance document on
antibiotic use in 2003. More recently, working collaboratively with industry leadership and
trusted academic advisors, we updated our global policy statement in 2015, and again
in 2017, a policy that we refer to as “our vision for antimicrobial stewardship,” or
VAS, for short. This stewardship document provides guidance to our supply chain while
establishing criteria on responsible antibiotic practices. It also commits McDonald’s to develop
species-specific policies; for example, our policy implemented for chicken in late 2017
and most recently that for beef. Ours is not a no-antibiotic-ever approach,
nor are we seeking a natural beef program. As McDonald’s doesn’t raise any livestock
or operate any slaughter facilities, our focus will be on partnering with producers and dairy
operators, the veterinary practitioner, industry leadership, and our suppliers to refine the
use of antibiotics, using the right drug to treat the right bug at the right time; reducing
antibiotic use, and ultimately replacing antibiotics, using a preventive approach. As such, McDonald’s
is committed to the responsible use of antibiotics. Responsible antibiotic use is important for
McDonald’s for three key reasons; first, healthy animals provide us the ability to serve our
customers safe food, and for a company that’s built a reputation for 60-plus years on serving
safe food, this is a non-negotiable for us. Second, we’re steadfast in our decades-old
commitment to improving the health and welfare of animals in our supply chain throughout
their lives. Therefore, our expectations of those directly responsible for the care of
animals raised for food, is treatment of animals when treatment is required, under the guidance
of a veterinary. And third, we believe these efforts will preserve antibiotic effectiveness
for future generations for both people and animals. Next slide, please. Our expertise runs — our expertise is in
running great restaurants and marketing hamburgers and French fries. Admittedly, we are not the
experts when it comes to antibiotic use or resistance, which is why we rely on global
authority, like the World Health Organization, as our north star, and the relationships that
we’ve developed with academia, veterinarians, and others. We don’t approach this important,
nuanced topic lightly. In order to create policies that are both impactful, implementable,
and sustainable, in the context of longevity, not greenness, it’s important for us to hear
from different stakeholders, which is why it took us over 18 months to develop our recent
beef policy. We acknowledge that this work isn’t perfect, but we also acknowledge that
perfect is the enemy of good. We do believe this is a good start, and we remain committed
to continuous improvement as we work with NGOs, academic partners, the agricultural
industry, veterinarians, and our supply chain, while measuring performance against our commitments.
Next slide, please. This past December, as many of you know, we
announced a new policy for antibiotic use in beef, focusing on our top 10 beef sourcing
markets that represent more than 85 percent of our global supply chain. To put this in
perspective, McDonald’s is one of the largest purchasers of beef in the world, and that
we purchase only about 1.3 percent of the available supply, demonstrating how fragmented
the beef supply chain really is and the number of purchasers in the marketplace. I want to provide just a few quick headlines
on our beef antibiotic policy, but first, I want to take a minute to just level set
by stating the obvious; the beef supply chain compared to chicken is complex. The vertically-integrated
nature of our chicken supply chain in many of our markets provides us a clear line of
sight back to the egg from which our chickens come. In many of our markets, chickens are
raised specifically for McDonald’s; slaughtered and processed in dedicated facilities where
we purchase the entire carcass. None of this is — none of this applies to
beef, making the development and implementation of this policy somewhat challenging. Furthermore,
to my knowledge, no one has tackled this topic on a global scale. So while the path forward
is unchartered, we believe our commitment and partnership with the agricultural community
and our supply chain is ambitious. Our policy follows the guidance established by the WHO,
the list of critically important antibiotics-to-human medicine, and is further supported by the
three Rs framework; to refine, reduce, and replace. Our policy regarding antibiotic use is simple;
first, antibiotics, defined by the World Health Organization as medically important, are not
permitted for the purposes of growth promotion. This is in line with U.S. regulation and that
of many other major markets globally. Next, routine use of medically important antibiotics
for prevention of disease are not permitted. As well, medically important antibiotics for
human medicine are not permitted for prevention of an infectious disease in food-producing
animals in our supply chain, with the exception in narrow — in non-routine, narrowly-defined
situations that we’ve identified within our policy. And thirdly, critically important
antibiotics for human medicine are also not permitted for control and/or treatment, and
of course, allowances are also defined within our policy. Next slide, please. So we’re taking a phased approach, understanding
that there is limited antibiotic-use data available across the global beef industry.
This is why McDonald’s, in collaboration with our suppliers and beef producers, is taking
a strategic and phased approach. Through our policy McDonald’s will partner with beef producers
in our top 10 beef sourcing markets to understand current antibiotic use across a diverse global
supply chain. By the end of 2020, based on data we collect
through these pilot tests, we’ll be able to establish market-specific, baseline antibiotic
use that will then further inform market-specific reduction targets. And finally, in — starting
in 2022, we’ll begin reporting progress against the market-specific reduction targets within
those 10 markets, using an independent third party, the Farm Animal Initiative, located
in Oxford, U.K. Last slide, please. We believe — we believe global challenges
require global solutions and diverse thinking. By “Using our Scale for Good” we embrace our
role at McDonald’s to be a part of the solution. This is why it’s one of the largest global
purchasers of beef. We took a thoughtful approach to creating our antibiotic policy and have
dedicated resources to implementing the policy across our global supply chain. Announcing
a policy was the easy part, but that isn’t where the work ends. We know we can’t accomplish
the goal of responsible antibiotic use without the partnership and support from all members
of our supply chain. We believe the power of partnership, collaboration, and consultation
is essential for success as we — as we move forward. We also believe strongly in cross-sector
initiatives and dialogues, like this very meeting, and the importance of having private
sector participation from companies like McDonald’s. Through forums like these, we can learn from
each other and leverage these lessons to make better decisions as a responsible organization. Thanks again for the opportunity to be here
this morning.>>Michael Apley: Thank you for joining us,
and we’ll look forward to your participation in our panel discussion. Next, we have Dr. Jeffrey Gerber from the
Children’s Hospital of Philadelphia. He’s going to speak to us about how patients can
affect the pediatrician’s behavior, with respect to antibiotic use. Welcome, and thank you
for joining us.>>Jeffrey Gerber: Thanks for the opportunity
to speak. I’m speaking here on behalf of the American Academy of Pediatrics as well. Next
slide, please. So I — my day job is as an Inpatient Antimicrobial
Stewardship Director. But more than 90 percent of antibiotics that are directly — directly
given to humans, occur in the outpatient setting, so I want to talk about ambulatory prescribing
and some of the ways that we can improve that. If you look here, this slide shows our antibiotic
prescribing in the United States, per capita. We prescribe more than 800 antibiotic prescriptions
per year, per thousand inhabitants. Compare that to Sweden; they prescribe fewer than
400 antibiotics per thousand. And their version of the CDC has targeted 250 because they think
this is too high, and I’m sure they’re — if they’re not there now, they’ll get there.
It’s not just quantity, it’s also quality. You can see here three of the most commonly
used broad-spectrum, outpatient antibiotics. We prescribe 4 times more quinolones, 15 times
more macrolides, and 10 times more cephalosporins than they do in Sweden, which — which has
significant implications. Next slide, please. The targets of these — or the — yeah, the
areas that we can target to improve antibiotic prescribing are many. It’s both not prescribing
antibiotics when they’re not indicated. It has to do with dose. It has to do with duration
of therapy. But this — this slide, I think, really represents one of the quintessential
problems with — with antibiotic prescribing. This is prescribing for acute bronchitis in
adults. We have more than 10 randomized, controlled, clinical trials that show that the prescribing
rate for antibiotics for — the prescribe — prescribing rate for acute bronchitis should
be zero. Antibiotics don’t help. But over the last 20 years and counting, we — we’ve
prescribed antibiotics to somewhere around 70 to 80 percent of patients who present in
the ambulatory setting with acute bronchitis. Next slide, please. So how do we address this problem? There have
been many studies that have shown promising results. I’m just going to show a few examples
that I think are thematically related. So this is a project that we did using our — at
the Children’s Hospital of Philadelphia, using an ambulatory care network of more than 30
primary care pediatric practices, more than 250 pediatricians, more than 250,000 patients,
all sharing a common electronic heath record. And this target here was on — I didn’t mention
this before — was on the choice of antibiotics. So again, broad-spectrum antibiotics being
less optimal than narrow-spectrum antibiotics. In pediatrics, it’s fairly straightforward.
There’s only a — a handful of conditions that dominate the landscape of prescribing,
and narrow-spectrum antibiotics, such as penicillin or amoxicillin, are indicated for almost all
of those. So to orient you, the Y axis shows the proportion
of broad-spectrum or off-guideline antibiotic prescribing for these common conditions, and
the X axis is time. You can see we had — this was a cluster randomized trial. Control groups
— hard to see the colors — they’re in the darker green circles. The interventions that
I’ll talk about in a second are indicated by the red Xs. And as you can see, more than
30 percent of prescribers were prescribing broad-spectrum or off-guideline antibiotics.
We — we developed an audit-and-feedback intervention where clinicians received personalized, private
“report cards” we call them, comparing their prescribing to their peers across this network,
according to AAP guidelines, and — and as a mechanism of peer comparison. As you can see, the left-sided arrow shows,
after the start of the intervention — you saw the intervention — so the group who received
this audit and feedback showed a relative reduction of nearly 50 percent in their off-guideline
antibiotic prescribing, which we thought was really good. After we stopped — this is an
HRQ-funded study — after we stopped the audit and feedback, you can see things reverted
back to the baseline. But I think — but I think it does demonstrate that audit and feedback
are ongoing. Audit and feedback does work. I will say that we’ve turned this into a QI
intervention that’s — that’s now — it doesn’t have an intervention and a control group.
It is — it is given to everybody, and all practitioners are prescribing more than 90
percent narrow-spectrum antibiotics. Next slide, please. So it’s important to find out what the drivers
are, why clinicians are prescribing antibiotics. They don’t just do it to randomly give people
antibiotics. They — they often know what’s right or wrong. We have a medical anthropologist,
who’s interested in stewardship, who works in our group, Julia Szymczak, who went out
and talked with providers or clinicians who prescribe these antibiotics, and many themes
emerged, but this was one of the most common. This is a representative quote from one of
the practitioners, “We have lots of parents who come in, and they know what they want.
They don’t care what” I have to — what “we have to say. They want the antibiotic that
they want because they know what is wrong with their child.” And this is — we aren’t
the only ones who have found this. And — and interestingly enough, this perception of — of
pressure is actually not always shared. There’s a — there’s — it’s — it’s not actually
shared with what the parents or the patients actually want. Rita Mangione-Smith, from the
University of Washington, has done a lot of great work showing that, actually, it’s a
misperception, and the parents actually just want to know what’s wrong and have a contingency
plan. And — and she actually does some great communication training, which is — which
is an important lever. Next slide, please. So just to build on these, what I will call,
non-clinical drivers of antibiotic prescribing; so I mentioned perceived parental pressure.
The presence of trainees; so the same doctors prescribe more judiciously when they’re with
a medical student, when — than when they’re there alone. Okay, that has nothing to do
with the clinical presentation of the — of the patient. Time of day; Jeff Linder has
done some really neat work to show that prescribing is at a — antibiotic prescribing for adults
in internal medicine practices is lowest at 8:00 a.m. It rises as you get toward lunch.
After lunch, it goes back down to the lowest levels and then rises back toward the end
of the day. Adjusting for the type of patient, right? So that has nothing to do with the
patient. That’s human — it’s a human behavioral act, and we’re affected by lots of different
things, including being hungry or tired. Patient race; we did a study showing that looking
at the same clinician, black patients — black children receive 25 percent fewer antibiotic
prescriptions and 25 fewer — 25 percent fewer broad-spectrum antibiotic prescriptions. Again,
it has nothing to do with the clinical presentation, adjusted for all demographic and clinical
factors that you could think of, or that we could think of. And then practice location;
the major predictor of getting azithromycin for pneumonia in our network is suburban location.
Next slide, please. So building on these, there have been some
really nice studies. I’ll just show you a couple that have — have capitalized on this.
This is a multi-country, European study, where just communication skills training, so talking
to — how to talk to patients about their concerns and expectations, how to — how to
get across the natural history of disease and set up a contingency plan; just doing
that led to a 30 percent reduction in inappropriate antibiotic prescribing. Next slide, please. And then just two more. Really interesting;
this is Daniella Meeker and Jason Doctor. These are behavioral economists, which is
a really important background to have in this business. This was a very simple study. Again,
a randomized trial where this is just a small snippet from a contract essentially that they
had internal medicine doctors read and sign to say that they would prescribe judiciously.
They then randomly assigned — they randomly assigned to doctors to sign these, blew it
up as a poster, put it in the room, the patient room where the encounter occurred, and so
both the doctor who signed it and the patient could see this commitment. And it led to a
20 percent reduction in inappropriate antibiotic prescribing for colds. Next slide, please. And then this last day
of the slide, the same group, again, Daniella Meeker, adjacent doctor, Jeff Linder, who
is an internist, Northwestern, this is a large study across nearly 50 internal medicine practices
in Boston and Los Angeles where they leveraged the electronic health record. Again, looking
at different socio-behavioral levers where they had three different interventions. So, one, if you were going to prescribe for
a viral infection this is the suggested alternatives. It would say, “Antibiotics are generally not
indicated for this.” And provide some non-antibiotic symptom relief medications. Accountable justification,
you get a pop-up that said — that it would actually would allow you to justify why you’re
prescribing the antibiotic. And if you didn’t type something in, “no justification
given” would populate the chart. And then the third, similar to the study I showed you
before, was peer comparison. This was not in real time, but every month, those prescribers
who were in the top 10 percent, most judicious prescribers, got a letter that said they were
a top performer. The other 90 percent got a letter to say that
they were not a top performer; doctors don’t like that. And I don’t have the graph to show
you, but all three showed a significant reduction in inappropriate prescribing. The peer comparison
was actually the most powerful. Next slide, please. So, this is just a summary and some points
of emphasis that I wanted to make on behalf of the AAP. Outpatient use, as I mentioned
before, is by far the largest proportion of direct human exposure to antibiotics. It doesn’t
seem that it’s proportionally reflected in the current national prescribing plan. Kids get a ton of antibiotics. I know there
are fewer kids than adults, but kids get them at the highest rate; 30 percent of all antibiotic
outpatient prescribing is to children. And they get them at really important windows. So, 30 percent of laboring mothers receive
prophylactic antibiotics that can get to the child; 5 to 10 percent of kids who are born,
healthy term babies who are born receive antibiotics. Most of that are unnecessary. If they are
preterm, it’s almost 100 percent receive broad spectrum I.V. antibiotics. And then after that, you make it through and
you’re healthy, you get more than one antibiotic prescription per year after that. And there
are currently, just to throw out there what they — if you would like to hear, there are
not pediatricians currently on the council. We think it’s important to highlight the direct
patient harm, right? So, antibiotic resistance is important. But
antibiotics, when you put a chemical in your body that you don’t need, you then have potentially
unopposed harm, organ toxicity, C. difficile infections, the microbiome, Dr. Blaser has
done amazing pioneering work to show that antibiotics can change the microbiome. The
microbiome educates your immune system. You immune system, when dis-regulated, can lead
to autoinflammatory/autoimmune diseases or a dis-regulated response to infections. And then the last two just summarize that
socio-behavioral levers such as odd [phonetic sp] and feedback, communication training,
and holding clinicians accountable can be effective in improving prescribing, thank
you.>>Michael Apley: Thank you very much, Dr.
Gerber. And now for our last presentation on the panel before our discussion, Harshika
Sarbajna from Sandoz will talk with us about international sustainability of antibiotics.
Welcome and thank you.>>Harshika Sarbajna: Thank you, and hi, everyone.
I am Harshika Sarbajna, the global head of anti-infectives at Sandoz. And I’ll take a
quick minute to introduce why I’m here today. Sandoz is the world’s largest generic manufacturer
of antibiotics, primarily for human use. We have business across 130 countries today.
And, in fact, we were the ones who discovered all penicillins back in 1951. We were called
then Biochemie and now Sandoz. So, we have a very long and rich heritage in antibiotics. And therefore we feel it’s upon us to make
sure we keep the antibiotics — existing antibiotics working as long as possible. Next slide, please.
We all know the antibiotics we have today cover and cure 90 percent of the infections
that are out there. However, the focus on AMR and the conversations
around AMR have shifted to talk a lot about the development of newer antibiotics. And
we, as the industry, really welcome that conversation. However, I think we also believe that that
conversation shouldn’t also include the existing antibiotics. As my role as global head of antibiotics,
I speak a lot with customers; I oversee the commercial operations of our business. And
one of the most alarming things that I get to hear from my — from whom I call “customers”
which are my healthcare professionals, my pharmacists, doctors. They say, “Yes, you
know, we need new antibiotics, Harshika, maybe in 10 years. But what we need today is the
right antibiotic at the right time.” Next slide, please. Poor access to right antibiotics
is a massive problem. I think a lot of practitioners would agree with me when I say this, right,
there’s so much shortage of antibiotics. I was reading this report from — which was
quoted by AMF foundation which said, in 2013 itself there were about 148 shortages of antibiotics
in U.S. alone. I was at a meeting organized by WHO last November, where they got together
all the European national healthcare authorities. And each single one of them just talked about
shortages of antibiotics and all the things that they have to do today to manage the shortages. So, it’s a true problem. And we all understand
what impact it has on the society; it leads to suboptimal treatments, it leads to delayed
treatments. But, also, for the rest of the system, not only it has impact on, you know,
costs and higher chances of mortality and morbidity, but because of the unique nature
of antibiotics, it also exacerbates the problem of AMR. If you do not give your patient the right
antibiotic, you are definitely giving a suboptimal treatment. You’re going for a broad-spectrum
antibiotic which only increases the chances of AMR. So, it is a true problem and I’m very
keen that we start talking more about this problem which is existence antibiotic and
their sustainability. So, what are the causes, what are the reasons
of this existing antibiotics industry feeling the heat it does? And why are there so many
shortages? Next slide, please. So, of course, the primary reasons, and I think there was
a public meeting last October or November which was to talk about shortages of antibiotics. I see a lot of my counterparts were at that
meeting. So, we all very well now understand that the primary driver behind such an unsustainable
environment for existing antibiotics is driven by economics. There is definitely an imbalance
when it comes to pricing and we all understand that. Today you can get a sterile vile of antibiotic
for less than a bottle of water. And that has made it, I would say, too affordable.
So, when I go to low and middle income countries, yes, there is access problem because these
drugs sometimes are not affordable. I always say when I come to U.S. and, you
know, and stay in Europe and go around in Europe the problem is its too affordable,
right? So, either patients or, you know, we end up overusing them. Or the other side is
because they are too affordable, the industry cannot afford to now manufacture or invest
into these antibiotics the way we would like to. And this economic problem has of course led
to the fragile supply chain that we see today, right? So, we, as an industry, as Sandoz we
have our own API manufacturing, but we also take raw materials from multiple suppliers.
And it’s at an alarming rate, the number of consolidations within that industry. So, it’s — the whole supply chain is slowly
breaking down part by part. And I think there is time — there is still time for us to do
something about it. But it’s also not everything is around pricing and economics of existing
antibiotics. I would definitely say there are issues around
regulatory. Today, the burden of keeping the dossiers or keeping these antibiotics alive
with each of the regulatory, and I just don’t talk about U.S., I work a lot with the Europe
authorities, is massive. It can cost keeping an existing antibiotic can keep us, can cost
an industry player anywhere between 300,000 to $1 million to just keep that antibiotic
dossier alive at the regulatory authority. And that kind of burden is definitely something
that’s leading the industry to go away. Now I, you know, you must have all seen recently
one of the largest antibiotic manufacturers, they recently closed down their plants. In
India, one closed down in India, the other one closed down in U.K. And it’s hard to see
fellow manufacturing slowly moving away from this industry. We state committed but also we want to do
more. We just started a year ago a very robust AMR program where we reach out to — at Sandoz
where we reach out to markets for stewardship, we engage with physicians, you know, to talk
about the problems or for prescribing or incorrect prescribing of antibiotics. We work — we
have a large manufacturing set up. We make sure that the water that leaves — we
call it, “The water that leaves our plants should be cleaner than the water that we get
inside.” So those are typical things that we work on. But we want to do more and that’s
only possible if you get that collaboration from everyone. So, that’s the problem. But what’s the fix
that we suggest? Next slide, please. So, the fix for the long terms is, of course, one
of the things that I always say is, “Please hold the manufacturers, the industry, the
pharma industry accountable. Hold us accountable for quality and reliability
but not offering you the lowest price. Look for manufacturers who are truly committed
to playing or serving the community for the longer term rather than just making a buck,
you know, for the year or for two years. So, that’s very important. Of course, promote a healthy market. One of
the things we can do definitely is start valuing antibiotics by value rather than by volume.
Recently, U.K. took a massive step when they said they will start now pricing antibiotics
by value and not by volume. And I urge U.K. government and other governments
to also include existing antibiotics because a lot of these programs have now started,
you know, shifting away focus into only new antibiotics. But let’s not forget the existing
antibiotics; they should be definitely there in such programs. Of course, there could be,
you know, we could do other things. You know, as an industry what we’ve started
doing, I’m also on the board of the AMR Industry Alliance which was formed after the 2016 Davos
agreement. We have about more that hundred large and small pharma antibiotic companies
who’ve joined the fight against AMR. Next slide, please. But we also believe that beyond just, you
know, having us — we end up working in silos. So, the industry is all together and acting
on, you know, different measures that we can do. But it’s now time and this is the time
that we all should start working together. We definitely need the health authorities;
we definitely need nonprofit organizations; we definitely need industry; and we also definitely
need payers who end up paying for these antibiotics. Your insurers, your health systems all on
the same table and talk about how we make sure that we keep the existing antibiotics
industry running as it should. To conclude, I would only say, “Let’s treat antibiotics
as special because they are.” No other therapy area has the kind of consequence
on our generations to come as antibiotics and they are special and let’s keep them that
way, thank you.>>Michael Apley: Thank you very much, and
thanks again to our panel. We will start going around for questions. Dr. Blaser has indicated
he has one. And we’ll let him start off, Dr. Blaser.>>Martin Blaser: Thank you. Thank you panelists,
terrific panel, a lot of interesting ideas, food for thought as we consider how to advise
the government on the next five year plan, I would like to talk — address my question
to Mr. Feinberg from McDonalds. Personally, I’d like to commend you for the philosophy
you expressed for McDonalds and the steps you’re taking in antibiotic stewardship. To
me it’s very refreshing, especially from a company of your scale. So, my question is can you do well by doing
good? And the question is will this kind of work enable you to take the position that
you’re helping the public health? That you’re serving a more healthful product? Can you
— in supermarkets now companies they’re selling antibiotic-free meat are getting a big premium
for their product. Can you — do you think that you can a premium
for your food provided in a very antibiotic-conscious manner? That’s my question.>>Bruce Feinberg: Yeah, it’s — thanks for
the question. It’s an interesting question, too. And, of course, I think, you know, there’s
a huge difference between McDonalds as a food service company and a local retailer that
might have a claim on label. Very difficult for us at our store level to
make label claims like those. And then, lots of our markets there would be regulations
that would prohibit those sorts of marketing initiatives. For us, we’re not really in it
for, as you described, you know, making an impact as you mentioned. You know, for us, it’s really trying to work
more with the producers, as I said in my comments, around a more responsible approach to antibiotic
use. We’ve had the opportunity to work, you know, cross-functionally and with lots of,
as I indicated, academic experts and subject matter experts. And one, in particular, helped
us to understand a few years ago that as it related to food/animal production, less is
probably better but zero is not likely an option. So, for us, you know, quite simply, it’s not
about labels; it’s trying to actually do the right thing. And true to our stewardship document
that we initiated in 2015, it really speaks to, you know, trying to preserve the efficacy
of antibiotics for future generations by making better decisions today.>>Michael Apley: Dr. Ginocchio, it’s your
turn.>>Christine Ginocchio: I’d like to thank
the panel for their interesting presentations. And this question is for Dr. Gerber. It was
interesting in the studies you presented by just a single statement they were able to
show a 20 percent decrease in antibiotic usage. But I didn’t see anywhere where you discussed
the use of adding on a rapid diagnostic that would either confirm or refute what the physician
felt. So, in the inpatient setting, it’s common,
we use rapid comprehensive diagnostics to better guide it, and maybe reduce antibiotic
consumption. But, as you mentioned, in the outpatient setting it’s one of the biggest
caveats that we have to — for giving antibiotics. So, one of the arguments is, “Yeah, well,
we can only treat influenza so let’s just test from flu A, flu B, and, say, RSV.” But, yet, what do you think? I mean, the impact
would be just as great to use, say, a more broad where you may have a virus. You can’t
treat that particular virus. But then being able to say to the mother or the father and
that this child does have a viral infection, that an antibiotic is really not indicated
in, say, a normy, healthy, 5-year-old. So, where is your placement in the outpatient
setting for these type of diagnostics then?>>Jeffrey Gerber: Yeah, no, it’s a really
good question; there’s a lot of work there. I don’t think there are enough data. So, the
problem is with, you know, as I said with — acute respiratory infections account for
75 percent of all prescribing to children. And there’s just a couple things or a few
things. Otitis media, strep throat, sinusitis, they’re all started by viruses and they become
bacterial. So, I’m not aware of great data that can use a viral diagnostic to differentiate
those things. So, the problem is you need to do studies
to show that that rapid diagnostic actually will predict that the patient doesn’t need
antibiotics. I know this sounds — it kind of sounds backward, but all, almost all, bacterial
respiratory infections start with a virus. So, the data need to be better to actually
prove that just having rhinovirus present means that you don’t have, you know, you don’t
have a sinusitis. So, there — it’s still a clinical diagnosis.
And so, you need something more sophisticated like RNA profiling expression or genetic — to
really actually distinguish between those two things. And the epidemiology studies just
aren’t there yet.>>Christine Ginocchio: [inaudible] 20 percent
— in the 20 percent that you were able to convince the patient that they didn’t need
an antibiotic –>>Jeffrey Gerber: Yeah, it’s — [talking simultaneously]>>Christine Ginocchio: So, that was based
on clinical, right?>>Jeffrey Gerber: It’s based on clinical
diagnosis, yeah.>>Christine Ginocchio: So, with that same
clinical scenario –>>Jeffrey Gerber: Yeah.>>Christine Ginocchio: — but they’re still
uncomfortable, the parents, say, maybe that would be another step towards improvement
with that same clinical scenario.>>Jeffrey Gerber: Yeah, so, if you can — and
so, if you can — if the data are there to actually support the whatever the rapid diagnostic
is that confirms the clinical diagnosis, again, showing that an antibiotic wouldn’t be needed.
Then I think that could be helpful, but we’re just not there yet. I think they’re probably
is a place for rapid point-of-care diagnostics, but we need the epi studies to back it up.>>Michael Apley: Thank you. Dr. Cray, we’ll
continue with you.>>Paula Fedorka-Cray: Thank you, very nice
presentations. Quite a bit of information there, this question is for Dr. Graham. When
you looked at your population of children even though it was small, 64, what were the
age ranges of those children?>>Jay Graham: So, most — we started off
looking at enteric pathogens because under five mortality due to diarrhea. So, we’re
focused on children under 5. About 80 percent of children who die from diarrhea are under
the age of 2. So, we really tried to focus on really young
children. We now have a new study, we have three exposure groups. So, we have children
that live with small-scale livestock, children that live with small-scale livestock and live
near large industrial farms, and then we have kids that have no small-scale livestock. So, we now we just started a longitudinal
study to better understand with a bigger population and focusing on antimicrobial resistance.>>Paula Fedorka-Cray: So, if I may have a
follow-up, couple follow-up — so, your intention is to keep the population at under 5?>>Jay Graham: That’s right. There’s research
that show that because at that age there’s a lot of –>>Paula Fedorka-Cray: Right.>>Jay Graham: — of movement on the ground.
Lot of hand to mouth behaviors and that they’re vulnerable at that age is their gut, microbiome-ists
developing.>>Paula Fedorka-Cray: There’s also a lot
of mortality associated with age range, too. Are you — so, part of my — I don’t want
to say concern — but part of my question would be is that really reflective of what
the long-term community — yes, I understand they pick it up. There’s a lot of hand/mouth,
there’s a lot of contact with the environment, but what about populations that will then
integrate into the community as they — because they, in fact, have made it out of the high
mortality period?>>Jay Graham: Yeah, I mean, it’s — Ecuador
is an interesting place because they actually — these communities do have piped water and
flush toilets. So, it’s fairly advanced in terms — that’s why I was trying to distinguish
between low income countries and, maybe, upper middle income countries. But we, I think,
it’s in ideals but to understand zoonotic enteric infections. So, I don’t think — we don’t see a lot of
— we do see a high incidence of diarrhea. We don’t see mortality due to diarrhea very
often in Ecuador. We do see some stunting and there’s more research showing that there
are certain organisms that are associated with enteric dysfunction. So, we’re — we have a proposal out now to
look at enteric dysfunction associated with certain — carriage of certain organisms.
So, that will be going on to see whether some of these exposures could affect stunting of
children. That’s not antimicrobial resistance [laughs] but it’s sort of related, so –>>Michael Apley: Thank you and so we can
get through everyone, great discussion conciseness, I guess [laughs]. Dr. Elaine Johnson, please
— Larson, I’m sorry [laughs].>>Elaine Larson: Sure, this is for Jay Graham,
also. This really reminds me what you did that we need to take a global approach. Because
I live in Manhattan and in our neighborhood about 70/75 percent are immigrants, first
generation, from the Dominican Republic and others. And so, I was in a bodega some years ago and
right on the shelf was chloramphenicol which was $1. And so, we did a study, IRB approved,
and we went to — we had people go into the bodegas, there are 22,000 bodegas in the U.S.
And in every, in every bodega they went into in this neighborhood they were able by asking,
not for an antibiotic, for something for a cold, they were able to get a series of different
antibiotics for a quarter a piece mixed in a bottle or together, you know, the same ampicillin,
tetracycline, whatever. So, we have a huge problem in the U.S. I actually
met with the president of the Bodega Association, as I said there are thousands of them. And
he said, he used the Whac-A-Mole description. He said, “Well, we close one and we fine them,
but they make so much more money selling antibiotics than the fine that they just come back and
forth like this.” So, I called the Department of Education in
New York, in Albany, because they, ironically, manage this — the bodega thing. And they
said, “We’ve given up.”>>Female Speaker: [laughs]>>Elaine Larson: So, I’m really happy because
I think that we need to approach this from a national level. And although we have rules
about not OTC antibiotic selling, it’s happening all over the country. Particularly in large
cities like Miami, L.A., you know, places where there are a lot of immigrants. We also did a survey; these papers are published
about 450 Spanish-speaking households interviews in their homes. And we found that, in fact,
they feel that antibiotics — they came from a place where you can get them over the counter,
very cheaply, are muy fuerte, and, therefore, they’re good for anything where you need a
strong medicine, whether it’s asthma, a headache, or whatever. So, I feel very strongly that we need to take
this global approach. And Ecuador is not unique in the kind of thing you’re discussing. So,
sorry, it’s not a question. I have another question for later if there’s time.>>Michael Apley: Dr. Weinstein.>>Robert Weinstein: Yeah, I’ve been impressed
that large corporations and consumer requests have driven a lot of antibiotic reductions.
And there’s other examples in healthcare where what patients expect really drives what providers
do. And so, this is for Mr. Feinberg and it might sound facetious but it’s not. Have you guys considered turkeys as one of
your staples? Because it seems like, at least if I can extrapolate from what was made in
the last presentation, there’s a lot of antibiotic use in turkeys. Although, I guess from the
discussion it seems like it’s controversial how you measure that. But, nevertheless, it would seem like if turkeys
were on your menu and you required turkeys to be produced in the same way as chickens
then maybe some of the antibiotics used in turkeys might be markedly lowered. Because
I can’t think of any fast food chain that makes turkey burgers fast food. I guess maybe
Epic Burger does, but –>>Bruce Feinberg: Yeah, I think, so, the
short answer is not on the near term. But from a menu development standpoint — [laughter]>>Female Speaker: Did we talk about that?>>Bruce Feinberg: We have looked at turkey
over the years. It doesn’t register real high for, at least, our customer base. But I would
add to that that the improvements that we’ve seen within our poultry supply chain globally
would probably mirror some of your expectations that you think are certainly happening within
the turkey industry. We’ve got some great success stories that we’ve seen over the last
14, 16 months since we launched that policy.>>Robert Weinstein: I’m impressed by the
data you presented. And I would — I would push turkeys because places like Epic Burger,
which is a smaller chain, I guess. But I’m from Chicago so, you know, the Epic Burger
that’s in the near north side, seems to be pretty busy. So — [laughter] — and you’re from Chicago. So, I’d like to
go out for lunch with you one day.>>Bruce Feinberg: I’ll take that note back
to the menu folks, thanks. [laughter]>>Robert Weinstein: And I’ll take you for
lunch or dinner one day [laughs].>>Michael Apley: Dr. Caliendo.>>Angela Caliendo: So, my question is also
for Mr. Feinberg. The program you laid out is very interesting. My question is with the
fragmented supply chain that you describe, how are you going to enforce this? Have you — I’m sure you have a plan for how
you’re going to make sure that your producers are doing what you want them to do.>>Bruce Feinberg: Yeah, it’s a — it’s a
good question. We don’t necessarily think of what we do in terms of enforcement. You
know, I think enforcement has — that’s sort of scary. We leave that for, you know, large
organizations, you know, across the geographies that we work. Ours is more of an approach of continuous
improvement. We have a long-standing relationships with all our supply partners. Some of them
go back 60-plus years. And so, quite frankly, the way we will, to use your word, “enforce,”
is as we get to the end of this data collection process, we’ll sit down and have meaningful
conversations with the folks that helped us to actually organize the draft of the beef
policy. And then we’ll talk, specifically, about meaningful
reduction targets that will, again, be market specific. You know, we’re talking about doing
a global analysis, that we’re not familiar that anyone else has ever done before. Coming
out of that information, the first step, as I indicated, will be establishing market-specific
baseline use. We already know, before the test starts, that
there’s significant differences between Australia and Brazil, as an example. The breeds are
different; the climates are different; the age of animal is different; disease pressures
are different. It goes on and on and on, right? But, to sort of address the question of enforcement
long term, we’ll develop — through the further enhancement of the policy, we’ll develop tracking
mechanisms, that we will, again, use our supply partners to help us monitor what comes into
our supply chain. One of the unique positions that McDonald’s
is in, we have very close control over our raw material supply. We actually monitor that
through an approved supplier list. No one can buy any protein raw material unless that
protein supplier shows up on an approved supplier list. And we audit against that frequently.
So our suppliers, our partners know, that in order to stay in good steed with the organization,
they have to follow the rules, and that certainly would help us to enforce.>>Michael Apley: We are going to enter our
lightning round now. I have Drs. Tarkington, Kesterson, Laxminarayan, Toney, King, and
Marty, and we will consider Dr. Marty our last question, and Dr. Kesterson, please.>>Gregg Kesterson: So, excellent talks. Just
a question for Dr. Gerber. You know, I was struck by the fact that, in the factors, that
the presence of trainees in a practice seemed to be contributing to reduced amount of antibiotic
or inappropriate antibiotic prescribing. So, where does the system fail? I mean, clearly
if the trainees are there, and are espousing the party line, you know, should you really
be prescribing that antibiotic? I’ve been taught that that’s not appropriate. Where
does it break down? I mean, do we still fundamentally have a failure of the medical education system,
or the medical education continuum? Where does that happen?>>Jeffrey Gerber: So, I’m not a sociologist,
so I’m just completely speculating. I don’t think, though — we go — and I go with the
sociologists to talk with a lot of frontline prescribers, and it doesn’t seem like an education
issue or a knowledge base. They don’t — you know, we tell them what the AAP guidelines
are, they kind of roll their eyes — “We know what that is,” and they bring up pressures
from parents, from the business model of urgent care practices, if they don’t go here they’re
going to go to the urgent care practice and get their Z-pack, and so, I guess my sense
of that is, there’s a sort of balance of pressures, that doctors know what the right thing to
do is, but when they’re in the room with a patient or a family who they feel like is
demanding an antibiotic, they’re going to do it. If you throw a medical suit in there
who’s really idealistic and that might swing the balance of that decision. So I guess, if you see what I’m saying, it’s
not about — it’s not the medical student reminding them and showing them the card about
what the appropriate thing to do is, I think it’s more — their behavior is contextual,
and that’s a different context. That’s the best I can say, not knowing anything about
behavior [laughs].>>Michael Apley: Thank you. Next, Dr. Laxminarayan,
and Dr. Cosgrove, I do have you in the cue, I didn’t mention earlier.>>Ramanan Laxminarayan: So, Dr. Feinberg,
I don’t know how many of the burgers you sell outside of the United States, but in the past,
I recall that companies such as yours had difficulty sourcing enough of the antibiotic-free
meat. I don’t know if that was specific to McDonald’s, but I remember reading that others
had difficulty finding enough suppliers that were willing to supply antibiotic-free meat.
And I guess that’s true sometimes for organic foods as well. Do you face these issues outside of the United
States? I don’t know if you said in China, for instance. So is that an issue in China?
And how would you solve this in places other than the U.S., which has regulations on the
use of medically important antibiotics in animals, and of course in Europe, which has
had them for a long time? How do you deal with this in the other countries?>>Bruce Feinberg: So, if I understand the
question, it’s around antibiotic-free meat and markets outside the U.S. So, I really
can’t answer that question, because that’s not our approach; that’s not our policy. Our
policy is not antibiotic-free meat. Our policy is around responsible antibiotic use.>>Ramanan Laxminarayan: Sure, but, you know,
how would you enforce that in all– how would you source antibiotics in meat that’s been
raised responsibly, outside of the United States, in places where you might not have
these kinds of suppliers?>>Bruce Feinberg: Yeah, so I think it, more
or less, gets back to the previous question. It’s one of working within our supply chain
and basically leveraging the relationships that we have with our finished product suppliers,
who we hold responsible for adequately or appropriately sourcing raw material. So, I
really can’t answer the question directly around antibiotic-free. Again, that’s not
our approach. But from a sourcing perspective, we have a very robust supply chain. We have
suppliers, supply partners, who stand very firmly, you know, in helping McDonald’s to
make sure we don’t have any issues from a supply chain standpoint. It just hasn’t been
an issue for us, either in the United States, or in any of the other 120 markets in which
we do business. So I’m not really sure how to answer the question.>>Michael Apley: Thank you. Dr. Toney.>>Denise Toney: Great presentations. My question
is for Dr. Gerber. I’m curious if you have any data looking at prescribing practices
of the minute clinics, and the prompt-cares that seem to be popping up in pharmacies across
the country, and whether there are increased prescribing practices of giving antibiotics
because I hear a lot, in parents saying, if they want to get an antibiotic for their kids,
they’re going to take them to the prompt-cares and the minute-clinics, because their pediatricians
would never give them an antibiotic, and I wonder if there’s data to support that there’s
lots more antibiotics being prescribed, in these settings, given where they’re located,
right next to the pharmacies.>>Jeffrey Gerber: Yeah, there are some data.
What’s been published suggests generally that– so there’s retail clinics, and there’s urgent.
The retail clinic industry is actually dominated by just a few major groups, I think it’s Walgreens
and maybe even Wal-Mart, so there was a really nice New England Journal couple of articles,
and data articles, and also commentaries on this. And they actually do pretty well. When
you compare them to internal medicine and to pediatrics, they do as good or better,
in terms of their antibiotic prescribing. I think the speculation is that they’re very
controlled, they’re regimented, they have certain criteria to make diagnoses and to
prescribe antibiotics, so they do okay. Urgent care is a much more fragmented industry,
and there’s a lot of variability in urgent care, and it’s hard to get the data, because
they don’t have these large, electronically linked data sets. But it does seem that they
are less judicious. And it also, there’s just a wide variety. As one example, not to promote
our own place, but in our care network, we now have three urgent care centers, and they’re
modeled just like the primary care practices, and we’re pulling the data right now, and
it does seem, or at least the impression talking with the pediatric providers who are getting
providers from there, they say they do a good job. It’s the minute clinic or the other urgent
cares down the street. So I think there’s a big difference. It’s just very difficult
to get data from urgent care because they tend to be individual, small chains that are
all over the place. It’s certainly the perception. We were just
two days ago, in a pediatric practice, the perception is that, you walk in, you get azithromycin
or whatever it might be, and, no matter what, and you go home. So it’s a problem, but a
hard data point to get.>>Michael Apley: Thank you. Dr. Talkington.>>Kathryn Talkington: Thanks. This is also
for Jeff. I think the good news is, in the last few years, we have learned a lot. We
have learned about some interventions that work. I think the challenge now, going forward,
is how do we get people to take those interventions, and use them. How do we get more stewardship,
particularly in the outpatient setting? And I was wondering, if you have any thoughts
on how we get people to take up those programs you suggest?>>Jeffrey Gerber: It’s hard, and I think
it’s harder than inpatient stewardship, where you have a captive audience, and there tend
to be more resources. It’s hard to find resources, especially in smaller practices. But certainly
in, we’re doing some disseminating work, a lot of people are doing some dissemination
work in larger networks that have shared electronic health records. Even small, the market share,
or the uptake of electronic health records has increased. Most practices, even small,
are on those electronic health records. So we and others have developed some tools, we
call sort of vendor-agnostic toolkits, that can be applied across vendors, to say how
you can pull data and feed it back. How you can use clinical decision support, basic-level
clinical decision support, to try to promote this type of work. But it is challenging,
because not everyone has an IT person who can pull those data, and feed it back. It’s
tough.>>Michael Apley: Thank you. Dr. King.>>Lonnie King: Great. So thank you for all
the presentations. So Feinberg, first, a question, and we’ve heard a lot yesterday, and even
this morning, about the power of alliances, where manufacturers got together, and they
really made a difference in starting to get together to do something about the environment.
So I know you’re in a highly competitive environment yourself, but I’m just trying to think, what
you might recommend about an alliance of yourself, or your competitors. And I can remember a
decade or so ago, where food safety was a differentiation of a food product. And, leaders
got together in the industry, and decided, no, food safety really is a principle, and
an outcome that we all want. So we’re going to quit marketing on that, and just say that’s
a common good. And maybe, I don’t know if we’re reaching
the point of not, and in food and antibiotic use, but is it now possible that an alliance
of leaders, and of course McDonald’s would be a leader, and take that strategy with a
group of companies and go forward, and say, you know, this isn’t really a differentiation
of brand. It really is about a common good, and we all agree on this outcome. Is that
possible? Because there’s a lot of misunderstanding when you walk into the stores and see how
it’s done. Is that possible? And, are there any alliances
in your companies, highly competitive companies, as you move forward are able to do that?>>Bruce Feinberg: Thank you for the question.
And I think it goes beyond the realm of possibility. It’s actually to the point of practicality.
We’ve engaged with others, our competitors in the marketplace, not direct competitors
perhaps. There’s certainly an opportunity to do more of that, particularly as we’ve
released previous policies over the years. The issue that we typically face is everyone
wants to be second in line. It’s very difficult to be first. And of course McDonald’s, as
I indicated in my remarks, is proud to take that first step. But to answer the question
directly, we welcome any and all participation as it relates to improving animal health and
welfare, and particularly at the topic that we’re talking about today around responsible
antibiotic use. But yes, those conversations are taking place,
more frequently than you might think, and we look forward to being able to foster that
in the future.>>Michael Apley: Thank you. Dr. Cosgrove.>>Sara Cosgrove: I think it’s interesting
that on the one hand, there seems to be an, I think consumer interest in reducing antibiotic
exposure in food, and then on the other hand, some large, it seems, proportion of parents
and patients who really want to be prescribed antibiotics [laughs]. And I wonder, when McDonald’s
made the decision to go in this direction, did you have any consumer input in making
this decision, and to what extent, if you did focus groups or something like that, was
there a real interest in McDonald’s doing this? Because I’m not aware that we have a
lot of data that is the Venn diagram of these two situations, of get it out of the food,
but please, please give me my Z-pack. Just curious.>>Bruce Feinberg: Yeah, in fact, as you might
expect, McDonald’s has engaged in lots and lots of consumer research. Specific to this
topic, we’ve engaged in many consumer attitudinal studies over the years, most recently as it
related to antibiotic use, a multi-market, multi-country attitude study. And the interesting
thing that came out of that work, you know, first of all, you’ve got about five seconds
from a customer’s point of view to explain this whole dilemma, as you just described,
right. So the sound bite alone is very difficult to get through. But from a practical standpoint,
what we found from our research is that in spite of the fact that most customers can’t
differentiate between antibiotics and vitamins, moms typically tell us, their main concern
is what goes into the animal, goes into them. And again, for moms bringing kids to our restaurants,
that’s a significant business concern. So, yes, we’ve got tons of research. We listen
intently to our customers. We are customer-obsessed. I mean, we’re a very customer-facing organization.
We have no choice but not to do that.>>Michael Apley: Dr. Marty.>>Aileen Marty: Thank you. And thank you,
Jay, Bruce, Jeffrey, and Harshika for your excellent presentations. My question is back
to Bruce. You provided the processes at McDonald’s relevant for carb. Can you provide any insights
on how reflective McDonald’s practices and policies are, out of the global restaurant
community writ-large, and also can you please address McDonald’s view on the reality that
elements of a single hamburger go way beyond the beef, and that each element, the cheese,
the flour that goes into the bread, the pickle, et cetera, can come from vastly different
places, and will differ globally where you’re getting your supplies from, and how that impacts
on these issues. And if there’s time, if Harshika could comment on how the availability of components
of antibiotics, which can come from vastly different and very unique parts of the world,
how that impacts on the supply and demand, that would be awesome. If there’s time. But
first you. [laughter]>>Bruce Feinberg: Could you restate the question?
I’m–>>Aileen Marty: Two parts. Number one is
I want to know, if these policies and practices that McDonald’s has is reflective of what
you know about the restaurant, the global restaurant industry in general. And number
two is, it isn’t just the beef, right? And it isn’t just the turkey, or the chicken,
or the fish. It’s also all the other components are impacted by microbes, and those come from
vastly different areas, and they come together in one little patty that you eat, and I’m
wondering if McDonald’s has any insights into how they handle that part of the issue?>>Bruce Feinberg: So the second question
is probably easier for me to answer than the first. Not that I’m aware of, okay? So you
talk about these various different ingredients coming together. You know, from a supply chain
standpoint, we’re committed to sourcing locally as much as we possibly can. So I don’t know
if that addresses the issue or the question, but where beef is available at the local market
level, we will purchase it at the local market level. I indicated before we do business in 120 countries.
But we don’t source beef form 120 countries. Some of those markets don’t raise beef. They
don’t raise potatoes. They don’t raise wheat. So, you know, we try and source locally when
we can, but understanding that it’s a vast global supply chain, and we leverage that
as much as we possibly can.>>Aileen Marty: So the question is about
the other components that are in the burger, right, and what antibiotics those components
were exposed to, and whether you’re looking into that as an aspect of the problem. That
was I guess the end to the question.>>Bruce Feinberg: Yes, so I think the short
answer to that question is also, not at this point in time. Our focus is on the protein
component, so the chicken, as we’ve addressed, starting in 2017, most recently with beef.>>Aileen Marty: Thank you.>>Harshika Sarbajna: So, if I understand
your question correctly, you were wondering if the fragmentation of the supply chain has
an effect on overall supply, no?>>Aileen Marty: No. To make an antibiotic
often requires very unique components that can only be obtained from unique locations
on Earth, that are sometimes, it’s politically relevant if a particular antibiotic can be
made, if that particular location does not wish to provide that particular element needed
to create the antibiotic. So I’m wondering if you’ve explored that in
part of the supply chain issues that you were discussing.>>Harshika Sarbajna: So we manufacture almost
all off-patented antibiotic today. So to just pinpoint the problem that you are referring
to, we haven’t had that problem, however, the problem that we face today is because
the supply chain overall is so fragmented, keeping that quality and reliability control
is becoming harder. So we at Sandoz at least try to vertically integrate as much as possible.
However, you know, raw materials, excipients, just getting those in time, and in quality
that we want, is becoming harder. And I will say, just on top of that, unlike
maybe with, you know, Bruce and McDonald’s, the other problem we are continuing to face
is just the number of suppliers of these excipients, or raw materials, is becoming smaller and
smaller, almost every year. So every quarter, we have few players who just notify us that
they’ll be out of business in six months. So it’s becoming really hard for us to continue
chasing and looking for a new supplier with the quality and reliability that Sandoz, and,
you know, Sandoz is part of Novartis, that, you know, meets our quality criteria. So it’s
not a particular recent problem, but it’s overall fragmentation issue.>>Michael Apley: Thank you very much. Asking
forgiveness of the council members waiting for second round questions, we do need to
stay on schedule and give everyone a chance for a lunch break. We will be back in our
seats for a 1:15 start, under Dr. Blaser’s moderation of panel number seven. Thank you very much for the active discussion.
Thank you again to our panel. We value your input greatly. And let’s end by thanking our
panel.>>Female Speaker: Produced by the U.S. Department
of Health and Human Services, at taxpayer expense.

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