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Panelist Remarks and Discussion
Pages 5-32

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From page 5...
... The CDC report estimated 2 million illnesses caused by antibiotic resistance -- that is probably an underestimate given the limitation of our data -- and 23,000 deaths, and associated costs of up to maybe $20 billion is excess direct health care costs from antibiotic resistance. Globally, the WHO report on resistance echoes the concerns and how antibacterial resistance touches every country and every region.
From page 6...
... Really, this is where it comes together. Both the health care system and health care providers, we feel, are at the center of the action that we can take now to slow the trends and really reverse them, both in terms of strengthening infection prevention in health care facilities and prevention interventions in communities, and then stewardship.
From page 7...
... Fineberg mentioned actually highlights the core actions that we feel are necessary. A focus on prevention has also been mentioned.
From page 8...
... WHO, as well, is very, very concerned and has reached across sectors to animal health and other sectors as well, and has formed a strategic and technical advisory group that I serve on. They are enthusiastic about action and are taking to the World Health Assembly in a couple of weeks a resolution to charge them with developing a global action plan that then can translate into regional and country action plans.
From page 9...
... Who was there? There were South Americans, Asians, all bringing their unusual resistance genes or resistant bacteria.
From page 10...
... That connection is often through people or through the bacteria, themselves. There is a lot of discussion on the fate of the antibiotics that are being given to animals for animal health and, more so, for growth promotion.
From page 11...
... She looked at the antibiotic resistance profile of women taking antibiotics for urinary tract infections. Where did she look?
From page 12...
... I study the ecology of bacteria, and in particular, the evolutionary history of the resistance genes they carry. Now, I am a little out of place here because in my lab, we are focused on the microbes.
From page 13...
... coli, which is now dead. This other bacterium produced a protein that specifically targeted my urinary tract infection strain, but no other microbes.
From page 14...
... We are asking the pharmaceutical companies to essentially be insane, because we know the outcome: another tigecycline, another chloramphenicol, another penicillin will simply select for massive resistance as soon as it is on the market. That is exactly what has happened with the very few novel antibiotics we have produced in the last few years.
From page 15...
... We can talk more about it during the question and answer period. More challenging to think about, scientifically, is how we prevent inappropriate antibiotic prescriptions among people.
From page 16...
... The way we label antibiotics, unfortunately, accidentally encourages inappropriate antibiotic prescriptions. As we have said, antibiotics are kind of a community property because of this transmissible loss of efficacy.
From page 17...
... This is the future of antibiotic development in industry, public–private partnerships, defraying upfront cost and risk, and allowing the public a much bigger say into which drugs will get developed so that the market stops getting flooded with new skin drugs that we don't need any more of and start getting drugs to treat infections we are running out of drugs to treat. This will require new regulatory pathways.
From page 18...
... Maybe we need to modulate the host inflammatory response. The signs and symptoms of infections that we experience as clinical disease are driven in many infections much more so by the host response to the bacteria than by any specific activity that the bacteria undertakes in our body.
From page 19...
... That is something that is alluded to in the CDC's Detect and Protect Against Antibiotic Resistance initiative, where, clearly, we have examples of successes with CRE [carbapeneum-resistant Enterobacteriaceae] and MRSA [methicillinresistant Staphylococcus aureus]
From page 20...
... I think that refreshing and new looks at approaches, both immediate and prolonged, are needed. It would be great if we could develop novel approaches to infectious diseases, one of which we are actually practicing, which is to prevent the infection in the first place.
From page 21...
... What we need to do is, in the immortal words of Dave Gilbert [Professor of Medicine at Oregon Health Sciences University and former president of the Infectious Diseases Society of America] , achieve peaceful coexistence.
From page 22...
... I was trying to answer this question of multidrug resistance because it can come out of the single use, certainly low dose. The important point is that the stage is now set.
From page 23...
... We have systems. The National Healthcare Safety Network tracks resistance in health care settings.
From page 24...
... I think everybody might jump in here, but I can't let the opportunity go and not mention that our fellow agency has really taken important steps this year with voluntary label change of antibiotics for animals and limiting the use of antibiotics that are used with humans only for treating infections.
From page 25...
... If you can reduce development time and the development dollars are cut in half because half of them are paid for by government, the NPV calculation starts to look much more favorable. In a private for-profit company, if they can tap into R&D dollars from government and decrease upfront costs and shave years off the time line, that will have a profound effect on the ability of that division to develop new drugs.
From page 26...
... It is only addressing growth promotion. We are not even talking about routine disease prevention, preventing diseases that are occurring because of the way we are raising animals, production diseases.
From page 27...
... I alluded to the Global Action Plan that WHO is developing. The idea is that there would be many different approaches in different parts of the world.
From page 28...
... The problem is that we tend not to think about what is really affecting the fitness of that bacterial cell. We have no idea what these antibiotic resistance genes actually do for a living.
From page 29...
... All of you had mentioned the use and overuse of antibiotics and that leading to the problem of drug resistance. To me, it seems like it is a classic market failure problem where the true cost of using antibiotics in society is not being reflected in the prices.
From page 30...
... If you look at our Nature Reviews Drug Discovery publication, we modeled a novel therapy to treat carbapenem-resistant Acinetobacter as an example of a highly resistant Gram-negative. Using standard Medicare performance metrics for cost-efficacy, you could charge $30,000 for a course and still remain well below the $50,000 cost per quality metric that Medicare often uses as a benchmark.
From page 31...
... DR. DIXON: [Dennis Dixon, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, NIH]
From page 32...
... I think you will see beautiful consistency that we hope to be targeting with national funding opportunities and international funding opportunities. We also make the point that you have to put things in context.


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