PACCARB 11th Public Mtg, Day 2 Pt 5: PUBLIC COMMENT & Adjourn

PACCARB 11th Public Mtg, Day 2 Pt 5: PUBLIC COMMENT & Adjourn


>>Martin Blaser: We’ve now finished eight
sessions of panelists. We’ve come to the final activity of this public
meeting, which is our second section of public comment. We have four people who’ve indicated that
they want to comment and we’re going to have them come up to the microphone. They’re allowed up to five minutes to comment. And shortly after those comments are done,
we will adjourn for the day. So, I’d like to call on the first commenter,
Elizabeth Lovinger from Treatment and Action Group. Dr. or Ms. Lovinger, you are on. Elizabeth Lovinger: Thank you. And thank you to the members of the Presidential
Advisory Council on Combatting Antibiotic-Resistant Bacteria for the opportunity to speak today. My name is Elizabeth Lovinger and I’m here
representing my organization, Treatment Action Group, or TAG. My comments will speak to goal four of the
plan on the need to accelerate basic and applied research and development for new antibiotics,
other therapeutics, and vaccines. As you may know, tuberculosis or TB remains
one of the most life-threatening bacterial diseases in the world with an ever-increasing
rate of drug resistance. More than 10 million globally fell ill with
TB in 2017, with half a million developing drug resistance. Even more stark, only 10 percent were cured
of their drug-resistant TB. The weight of TB as an AMR threat must not
go unaddressed. Drug-resistant TB is the leading cause of
deaths from AMR, which as the council must know, was declared a significant threat to
global public health by the United States and the World Health Organization in 2015. In order to best reduce the impact of deadly,
drug-resistant bacterial infections, such as TB, research agencies of the Departments
of Health and Human Services, such as BARDA and CDC, the Department of Defense, and the
State Department’s U.S. Agency for International Development, must prioritize a robust research
agenda into innovative diagnostics, better treatments, and effective preventive options,
including a vaccine for TB. The U.S. government’s long-standing role in
global TB research and development is noteworthy and laudable. In 2017, the United States led the way with
investing $313.5 million in TB R&D across several key agencies. Much of the research that has flowed from
U.S. investments has had global implications. Current options to prevent and treat drug-resistant
TB are limited, but U.S. agency investments into newer drugs in the past few years, such
as Bidacolin [phonetic sp] have yielded vital tools to combat drug-resistant TB, including
multi-drug-resistant TB. Recent trials of vaccines and treatment for
TB infection have found promising results. However, TB research spending constituted
only 0.007 percent of the overall gross domestic expenditure on research and development or,
as it’s sometimes called, GERD, by the U.S. government. More could be done in terms of increasing
investment with a relatively small amount of funding. And U.S. research agencies that currently
do not prioritize TB can be doing more and be given the potential opportunity to drive
innovation in this needed area of public and global health. To build on U.S. leadership in TB R&D and
success by supporting ongoing and future research, the U.S. government should increase HHS, DoD,
and State Department spending for TB research and development to reflect just 0.1 percent
of overall GERD expenditure, a fair-share funding target that has been recognized by
member states during the U.N. high-level meeting on TB this past September. This means investing an additional $131 million
on top of the current $313.5 million investment to boost total investments to $444.5 million
across U.S. agencies, including those with the ability to shift and catalyze new diagnostics,
treatments and vaccines. BARDA, for example, which remains an important
agency in developing the medical countermeasures and product development we need against AMR,
can do more to catalyze the tools needed to upend this threat. Increasing their investment will allow them
to contribute their innovative approach to product development to the benefit of ending
TB here and everywhere. This small increase in investment would support
the necessary research to eliminate drug-resistant TB as an AMR threat by 2030. Lastly, the U.S. fight against AMR must include
efforts against TB and increasing U.S. government funding for TB research would fulfill key
recommendation to advance needed public health tools across diagnostics, treatment, prevention
and vaccines through a well-resourced and science-based strategy that is led by the
best and brightest at our esteemed U.S. research institutions. Thank you.>>Martin Blaser: Thank you. I now call on Dr. Hua Wang from the Ohio State
University. Dr. Wang. Hua Wang: Thank you, Dr. Blaser. I’m Hua Wang and I am professor in the Department
of Food Science and Technology, Microbiology and Interdisciplinary Nutrition from the Ohio
State University. I am also a former chair in biotechnology
and food microbiology, Institute of Food Technology at American Society for Microbiology. I was also the U.S./U.K. Global Innovation
Initiative project lead on innovative mitigation for antibiotic resistance in the global ecosystem. I appreciate the event speakers presented
some very good data during a meeting, especially the talks on horizontal gene transfer and
the blood infections, which were right on target. Besides the key roles of microbiota and gene
transfer, we further heard repeatedly gut microbiota from Dr. Blaser as gut microbiota
dysbiosis is now known causative to many modern diseases from mental health disorders to diabetes. However, as the organizer of the first federal
agency-sponsored antibiotic resistant conference focused on commensal microbiota happened 10
years ago in D.C./Crystal City area, sponsored by USDA, based on our original discoveries
on the massive antibiotic-resistant gene pool in many ready-to-eat foods, including almost
all cheese and yogurt products on the market and horizontal gene transfer by full-blown
commensal microbiota, I actually felt sad instead of joy to hear 15 years after our
original discoveries, the topic is just becoming openly recognized. Meanwhile, the National Surveillance System,
NNDSS, is still mainly for disaster reporting, means where antibiotic resistance is detected
in pathogens, there’s no way to push it back instead of risk forecasting, while proposals
to collaborate with the agency has been ignored for over a decade. I challenge the comment to invest more on
political leadership instead of science and innovation. Antibiotic resistance is a scientific issue
needing scientific solutions instead of political manipulation, especially against science. As an example, without any political manipulation,
the mega food safety problem by commensal microbiota, including beneficial bacteria
infecting — impacting, almost all cheese and yogurt products on the market before 2007
was quickly solved in just four years by 2010, especially protected — effectively protected
both public health as well as the multi-billion dollar food industry in contrary to the intense
industry relationship, a messy situation in food/animal production industry. There are other antibiotic-resistant challenges
in the food chain that need to be addressed scientifically and responsibly. In addition, proper disease prevention and
treatment are essential and especial — usually quick treatment can prevent serious consequences
with minimized side effects. I further report here again that another knowledge
breakthrough revealed the mainstream practices of taking drugs orally and using the drugs
with wrong pharmacological property instead of using antibiotics itself being a key and
a direct driver for both massive antibiotic resistance and macrobiotic dysbiosis in hosts. As the organizer and chair delivered the 2015
GII International Collaboration Conference in Shanghai, innovative mitigation about antibiotic
resistance as well as the 2017 American Societal Microbiology Special Conference in D.C./Crystal
City area again, innovated microbial ecology and mitigation of antibiotic resistance and
bacterial diseases, referring to both infectious and non-communicable diseases. I’m reporting here that our scientific and
outreach effort has run into significant difficulties in the past couple years. Despite practical solutions to minimize the
side effects of both antibiotic-resistant and gut microbiota dysbiosis is already partially
available, the key risk of oral antibiotic administration remains a key — a kept secret
to the general public as well as the health care professionals and the policy makers. An objective — and antibiotic — oral — and
injective antibiotic options are not available for our patients. That is almost eight years after initial discovery,
six years since the official publication and multiple news release by America’s Society
of Microbiology, followed by the conference mentioned above. I’m fully — I also fully agree the early
comment from the panel that dosage is key to relevance. The antibiotic residuals in USDA-certified
meat and poultry products are much lower than MICs of bacteria while the high dosage of
therapeutic drugs, especially by oral administration, is the real cause to the side effects on gut
microbiota and hosts. It’s further important to recognize that proper
cooking effectively kills bacteria in foods, including antibiotic-resistant bacteria. The industry and consumers needs to know the
real risk is resistant bacteria from ready-to-eat foods as well as animal feces and wastes. While better food animal production practices
are critical and need to be encouraged, the potential health benefits of the corresponding
foods further need to be discovered. The scientific facts on antibiotic resistance
should not be messed up. Besides my previous comments in 2017 and 2018
on the need of food science expertise, I further agree that there is a need for expertise on
pharmacology in the committee. We need outreach and global collaboration,
but political campaign without the fundamental scientific truth has proven to be detrimental. While the damage of oral antibiotics remains
a hidden secret in the U.S., China released a policy since 2016 to eliminate IV injection
of antibiotics in clinics and promoting oral drugs, completely opposite to science and
against clinical evidences. In fact, in China, the province of vancomycin-resistant
enterococcus so far is less than 5 percent, while in the U.S., it’s already more than
50 percent. This is likely attributed to the unavailability
of oral vancomycin as an option in China. Clinical evidence in the U.S. has already
confirmed the oral administration of vancomycin is the true cause to the side effects mentioned. The history of penicillin resistance is another
illustration. The recent changes in policy in China is detrimental
to not only people there but also worldwide. As we already know, antibiotic-resistant bacteria
do not have country boundary. To this point, no single mainstream public
media dares to cover these facts and air the story. Furthermore, the online documentations regarding
the findings, including the information on the conference and the news releases, are
now mysteriously unavailable. It is unfortunate that the innovators are
so far suppressed and stressed, and new innovators’ science and solutions in this area are hindered. Antibiotic resistance should have never simply
been an avenue to get funding. Innovators and sponsors should be encouraged
instead of threatened and fear to communicate the scientific truth for being penalized and
losing funding and even jobs. In summary, 250 to 350 million antibiotic
prescriptions are given annually in this country, mostly being oral, impacting almost every
family and kids in this country, contributing to not only antibiotic resistance but the
epidemics of modern disease due to gut microbiota dysbiosis in generations. Antibiotics used in animals are still primarily
given by mouth, whether for food animal production or companion animals, by mixing with water
and feed. This is — it is unacceptable that the current
situation should be allowed to continue. Paradigm changes become necessary; cutting
edge science and scientists need to be recognized and empowered for more solutions. What we really need is scientific leaders
with successful records sit down with agency leaders to figure out the top priorities for
investment, key messages to disseminate, and support from the political leaders and industry
for implementation. What we don’t need is political dealership
further mess up and even mislead public knowledge, consumer opinions, and therefore policies
and practices causing massive losses. Thank you.>>Martin Blaser: Dr. Wang, thank you. I next call on David Wallinga from the National
Resource Defense Council. Dr. Wallinga. David Wallinga: Okay. Thank you. I hope the new National Action Plan prioritizes
a reporting on antibiotic use in food animals on a milligram per kilogram basis, as we discussed
a little bit this morning. There were a couple of questions so with your
forbearance, I just wanted to make a few clarifying observations that I think can help address
your questions. First, you should understand that the denominator
in a milligram per kilogram metric doesn’t reflect an actual measurement. In other words, no one’s going to be asking
our meat producers or farmers to go out and weigh their individual animals, at least not
for this purpose. Hence, there’s no additional burden that such
an approach would place on them. In fact, the kilograms in this denominator
reflects a very deliberate construct, a construct that’s supposed to represent the mass of the
entire population of animals that might receive antibiotics. Some basic assumptions have to be made in
calculating that denominator. Talking about antibiotics used in pig production,
for example, the denominator, using the European approach, would be calculated looking at the
number of finisher pigs slaughtered over the course of the year multiplied by 65 kilograms,
the assumed average weight at the time of slaughter, plus the total inventory of breeding
sows multiplied by 240 kilograms, their assumed average weight. They’re the average weights from the E.U. The same kind of assumptions would be made
as well over populations of cattle, chickens, turkeys, and other animals receiving antibiotics. So, for example, the assumed average weight
for chickens is one kilogram; for turkeys, six kilograms; for adult cattle, 425 kilograms;
all at the likely time of treatment. So, even though the average weights can vary
from country to country, in Europe, they specifically assume that the average weights are the same
across the E.U., so that then they can compare on a milligram per kilogram basis the usage
from one country to the next. So, my second point is this: these milligram-per-kilogram
calculations sound a lot more complicated that they actually are. And I think the evidence is the fact that
I could do them [laughs]. So, they’re not that complicated. Believe me. They’re actually pretty quick and easy to
do. So, in November, I did the calculations based
on the U.S. data for the U.S. And then I did them again after the FDA released
its latest figures on antibiotic sales because that affected the numerator, obviously. Each time, it took me no more than a couple
of hours, once the assumptions in the spreadsheet were set up to reflect those assumptions. Setting up the spreadsheets is actually pretty
easy because the European Medicines Agency developed the whole method almost a decade
ago, and they’ve published the methodology. It’s really transparent, and now we have a
decade of those methods being used and fine-tuned that we can learn from. Do I think the approach is perfect — in quotes,
“perfect?” No. What does that mean, even? Given the data now available in the U.S.,
it’s my opinion that that’s our best option and it’s certainly a better option than what
we do now, which is just to report antibiotic sales, which is a pretty crude measure, on
a volume basis. So, like Bruce Feinberg, I would urge that
we can’t let the perfect be the enemy of the good. And reporting on antibiotics used in food
animal production on a milligram per kilogram basis is better and more defensible that what,
in fact, has been done to date in the U.S. That’s why the National Action Plan should
make it a clear priority. I’m confident that if it were, our very capable
FDA staff could complete the calculations in no more than a couple of days. Last year, Public Health Canada, for the first
time, did these kind of milligram per kilogram calculations in their reporting. And they actually did it two different ways. First, they made Canada-specific assumptions
about animal weights, because they said, “Hey, our animals are not the same as the European
animal population.” Maybe they’re a little bigger, for example. And then they did the same calculations using
the same average weights as they used in the E.U. — and this is the good part — they
did those two sets and then they presented the results side by side so you could see
how the method determined the different results, the different conclusions. And, of course, there were some minor differences
but they weren’t significant. They still allowed for the same general conclusions
to be drawn regarding antibiotic use in Canadian food animals. And, more importantly I think, they allowed
for more direct comparison with that same antibiotic use by similar industries in European
countries, for example. So, thank you.>>Martin Blaser: Thank you, Dr. Wallinga. Our final commenter is Dr. Kevin Kavanagh
from Health Watch USA.>>Kevin Kavanagh: Thank you very much. We need to have a paradigm shift regarding
the infections of multi-drug-resistant organisms, one which is designed around the prevention
and promotion of an optimal protective microbiome. Antibiotic stewardship, although very important,
probably will not succeed as sole intervention. If a 50 percent reduction is achieved, there
will still be billions of bacteria exposed to antibiotics, resistance will still develop,
but hopefully at a slower rate. The importance of the microbiome, along with
antibiotic stewardship, is demonstrated by an up to 32 percent reduction observed in
C. difficile infections with proper prescription practices. This reduction is primarily due to the avoidance
of the destruction of the gastrointestinal tract’s beneficial bacteria, which help prevent
the acquisition and growth of C. difficile, along with the development of resistance. The most effective treatment for severe C.
difficile infections is not antibiotics, but microbiome reconstruction with fecal transplantation. Identification of carriers is also of importance. Currently, the World Healthcare Organization
recommends pre-operative testing for Staph aureus for all patients undergoing major surgery. And in countries with adequate resources,
which certainly the United States has, they recommend the testing of all surgical patients. In the United States, there is not even a
system-wide standard to preoperatively identify MRSA carriers, which could then allow for
their decolonization. I envision that, in the future, hand hygiene
will evolve to take on a different form, instead of destroying a hand’s microbiome over 200
times a day, risking exposure of that facilities microbiome at the same time, I feel that it
will take on a form which will be a more selective approach, performing microbiome destruction
when exposed to dangerous pathogens and in other cases performing cleansing, which includes
beneficial and protective bacteria. I cannot overstress the importance that our
healthcare system prepare for the testing of a patient’s microbiome. In the future, I believe that this will be
part of a standard physical examination. Knowledge of the microbiome’s characteristics
will be an important part in addressing many different types of diseases, not just infectious
disease. We need to build this capability. But until then, we can at least identify the
carriers of dangerous pathogens in an attempt to eliminate this carriage and to modify their
microbiome. Thank you.>>Martin Blaser: Thank you, Dr. Kavanagh. That concludes our public comments today and
the scientific portion of this public meeting. I’m going to turn the microphone to Dr. Musmar
for some final comments.>>Jomana Musmar: Everybody, thank you all
so much for a fantastic two days. We truly appreciate all our presenters for
joining us, and for those you that were able to come yesterday as well, to all of our panelists,
the council for being here, and especially to my team for putting these two days together. A special thanks to Iowali [phonetic sp],
Sarah Mclellan, Marcus Mirchek [phonetic sp], Dana Trevas, and Jennifer Adona. And I ask our presenters and panelists — everybody
with a badge — please leave those at the front, and those of you with lanyards, please
leave those as well. And thank you on behalf of me. Dr. Blaser?>>Martin Blaser: I will just say on behalf
of Dr. King and myself, all members of the PACCARB, we thank the presenters, we thank
the fellow council members, and the audience for your fortitude and patience in this cold
weather. This meeting is adjourned.>>Female Speaker: Produced by the U.S. Department
of Health and Human Services at taxpayer expense.

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