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Dr. Anthony Fauci

Tuesday, January 7th, 2014 - 14:26
What are the strategic priorities of the National Institute of Allergy and Infectious Diseases? What has been learned about emerging and re-emerging infectious diseases? What’s on the horizon for the NIAID? Join host Michael Keegan as he explore these questions and more with Dr. Anthony Fauci, director, NIAID.
Radio show date: 
Mon, 04/07/2014
Intro text: 
What are the strategic priorities of the National Institute of Allergy and Infectious Diseases? What has been learned about emerging and re-emerging infectious diseases? What’s on the horizon for the NIAID? Join host Michael Keegan as he explore these questions and more with Dr. Anthony Fauci, director, NIAID.
Complete transcript: 










Interviewer: Michael Keegan




Michael Keegan: Welcome to The Business of Government Hour. I'm Michael Keegan, your host and Managing Editor of The Business of Government Magazine.  



For more than six decades, the National Institute of Allergy and Infectious Diseases (NIAID), has been at the forefront of important research in infectious and immune mediated diseases, microbiology, immunology and related disciplines. It conducts and supports basic and applied research to better understand, diagnose, prevent and treat infectious diseases such as HIV/AIDS, tuberculosis and malaria, as well as immune mediated disorders such as Lupus and Type I Diabetes. This work has led to new vaccines, therapeutics, diagnostics and other technologies that have improved health and saved millions of lives in the United States and around the world.   


What are the strategic priorities of NIAID? How is NIAID accelerating findings from basic research into healthcare practice? What has been learned from emerging and reemerging infectious diseases? What's on the horizon for NIAID? We'll explore these questions and so much more with our very special guest Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases.  


Dr. Fauci, welcome back to the show. It's great to have you.  


Dr. Anthony Fauci: It’s good to be here with you.


Michael Keegan: Dr. Fauci, before we delve into specific initiatives, perhaps you can provide us with a brief overview of the history and mission of the National Institute of Allergy and Infectious Diseases, when was it created, and how its mission evolved to date. 


Dr. Anthony Fauci: Well, it was officially created in 1948. However, its origins really go back to the beginning of NIH because back in the late 1800s, during the period of time when there was a lot of immigration particularly from Europe, the United States Public Health Service had a station on Staten Island that actually would be examining people who would come over on ships to Ellis Island in New York Harbor.  They were mostly screening and surveillance for people who might have tuberculosis or small pox or things like that.


And then it grew under the radar screen as it were for a while, until they finally moved to Washington, D.C. That particularly hygienic laboratory Staten Island was really the first National Institute of Health, not necessarily solely devoted to infectious diseases but it was the beginning of the National Institute of Health. Dr. Joseph Kinyoun was the person who started that. In fact, when you go to the NIH building and you see the history with all the portraits there, Joseph Kinyoun's portrait is very prominent among them.


But for the official development and establishment of the National Institute of Allergy and Infectious Diseases, that was in 1948. And it's interesting how given the role of infectious diseases in health in general, and particularly the emerging importance of global health, the Institute has grown.  When I become director in 1984, it was about the 6th or 7th largest institute with appropriations of about 320 million dollars. Over the years, 3 decades almost, it has grown to be the second largest institute just immediately behind the National Cancer Institute with a budget of about 4.5 billion dollars.


So, you can see how the growth of the Institute and how it’s evolved because of things like emerging infections, the HIV/AIDS pandemic, the threat of influenza pandemics, emerging diseases like SARS, West Nile Virus, tuberculosis and malaria. So, we've really skyrocketed from a rather small institute among the many NIH institutes to now the second largest institute.


Michael Keegan: And how are you organized? In other words, you have the 4.8 billion dollar budget. How do you allot that in your organization?  


Dr. Anthony Fauci: Well, if you look at what we do, we mostly fund researchers who are in universities and research medical centers throughout the country, and to some extent the world. So, about 10 percent of our 4.5 billion dollars goes to intramural federal scientists, most of whom are located in our Bethesda campus, but we also have others, who are in Hamilton, Montana in our Rocky Mountain labs, a small contingent there.


The rest of it, the 80-90 percent goes out in grants and contracts to investigators in most of the major institutions throughout the country. Now within that, it's subdivided into multiple different disciplines. If you look at the major disciplines, our name tells what it is, the National Institute of Allergy and Infectious Diseases. The infectious disease part is everything from HIV/AIDS to emerging and reemerging infections, established infectious diseases and childhood diseases. We're responsible for vaccines, development of drugs and understanding the diseases.


The allergy immunology part is immune mediated disease, autoimmune diseases, asthma, allergy and things like that. And the reason they were put together is because in history, the immune system was understood in light of it being the body's defense against infections. That's how you link the immune system with infectious diseases and that's why it wound up in the same institute.


As years went by, we began to realize that not only does the immune system form a first line of defense against infectious diseases; there can also be diseases of the immune system like hypersensitivity, allergy, autoimmune diseases and things like that.


Michael Keegan: Great. And I just was wondering if you could help us, since you described sort of the research portfolio a little bit, could you tell us what basic applied and clinical research really is and how does it relate to your mission?  


Dr. Anthony Fauci: Well, basic applied in clinical are arbitrary type of designations but they do have some distinctions. When you talk about basic research, you're asking a fundamental question about a mechanism that may or may not be related to a particular goal for a drug or a vaccine or a diagnostic. Understanding how the immune system works, understanding the biology of different types of microbes, that's fundamental basic research.


When you go into applied clinical, now clinical research is a form of applied research so it’s essentially the basic concept development. Once you get beyond that, then you say, how am I going to apply this? And if it has to do with a human subject, you're going to be doing clinical research.


So, taking an example, you understand the mechanism of how a cell acts aberrantly. Then, you say how am I going to apply that to an autoimmune disease and can I intervene with a certain drug? Or you look at the basic viral biology of a virus and you understand its genomic makeup. Then, you look at is there a part of that genomic makeup that could be susceptible to a drug? So, can I design a drug to interfere with that? In fact, that's how we got the large list of drugs that we now have for HIV/AIDS where we have essentially transformed the lives of HIV infected individuals with drugs that really work. It was studying the HIV virus, looking at its replication cycle, so that goes under the category of basic research.


Once you establish that the enzyme reverse transcriptase, or protease, or integrase, or enzymes that the virus needs to replicate itself, then when you start designing a drug to block that particular component of the replication cycle, that becomes applied research.


Once you then take that drug and put it in a human in a phase one trial, first to see if it’s safe and then to see if it’s effective, then it becomes clinical research. So, there's that spectrum that goes from the fundamental basic concept, defined as basic research, up through and including applied and clinical research.


Michael Keegan: Very clear. Wonderful way of describing it. So, what about your role and responsibility leading the Institute? Could you tell us a little bit about that?  


Dr. Anthony Fauci: Well, as the director of a large institute that has a substantial budget, as I mentioned 4.5 billion dollars and close to 2,000 employees, when you are the leader of an institution like that, you have to provide vision and leadership. By leadership I mean lead by example. Establish the vision, pick the right people, don't micromanage, articulate your vision very clearly so that people understand where you're going and what the mission of the Institute is.


And then as a leader of a large institute, you have to be consistent in how you deal with people and how you deal with issues. And the reason I say that is that there will always be, maybe every day, someone or some group that you're going to disappoint because people have different viewpoints about how you should approach a particular problem.


If you guide yourself with a high degree of integrity and with the highest ethical principles and you're consistent so people can predict how you would respond to something. When you have to make tough decisions that disappoint people, they may not like it but at least they'll respect you and respect the institution.


So, it’s vision, leadership, consistency and making sure that you strive for excellence. Those are the principles that I use when I think of how I lead the National Institute of Allergy and Infectious Diseases.


Michael Keegan: I was wondering, given your time leading the organization, what are some of your maybe recently your top three challenges you face and how have you sought to address them?  


Dr. Anthony Fauci: Well, challenges. There are scientific challenges and there are management and logistic challenges. So, one of the major challenges that one has is that we are dealing right now, the reality, in an era of constrained resources where simultaneously it’s an unprecedented era of scientific opportunities. So, the challenge is in an arena of constrained resources, how do you get the best bang out of the buck? How do you push those extraordinarily ground breaking areas of research that ultimately will benefit public health at the same time as you realize that you have constrained resources. That requires prioritization, prioritization because there are a lot of good ideas. You can't pursue all of them. So, to me, that's really one of the important challenges.


The other is the particular challenge that is somewhat unique for my institute in that it’s the National Institute of Allergy and Infectious Diseases. Most every other institute at the NIH including ourselves is responsible for the basic and clinical research in the particular area for which we're responsible. If it’s the Heart, Lung and Blood Institute, it’s heart, lung and blood. If it’s the kidney, diabetes, it’s kidney for us; it’s infectious diseases and immunology. 


The issue with us is that in addition to that predictable translation from a basic concept to an applied clinical concept, we have to be ready at a moment's notice for a completely unexpected brand new infection where you go to bed at night and everything is fine. You wake up in the morning and you read in the Washington Post or the New York Times that there's an outbreak of an unknown disease somewhere and now it’s your responsibility to understand what it is, to discover it, to develop drugs for it, diagnostics and vaccines.


This is exactly what we were faced with in the summer of 1981 when we read in the CDC’s Morbidity and Mortality Weekly Report that there were first five cases of pneumocystis pneumonia in gay men from Los Angeles and then one month later an additional 26 young gay men from New York, San Francisco and LA who had this strange disease.


Immediately, it was our task to figure out what is that? When you identify it, what you can do about it? So, that's a kind of responsibility and challenge that is a bit different from an institute in which they have serious diseases but they're generally predictable. It isn't every week or month that a new cancer is discovered or a new form of heart disease where at any given time there'd be a brand new infectious disease. 


Michael Keegan: So, in a sense, you're tenure since 1984, what has been the biggest surprise in your tenure?  


Dr. Anthony Fauci: Well, it’s a surprise that now after so many surprises it’s not surprising any more, and that is the extraordinary --


Michael Keegan: It’s a constant state.  


Dr. Anthony Fauci: Exactly, it’s a constant state of surprise. And that is the extraordinary capability of microbes, virus, bacteria, parasites to evolve, emerge newly or reemerge in a different setting and under different circumstances.


So, if you look at that, for example, there's a truly newly emerging infection, 1981, HIV/AIDS. There may have been a little blip here and there in the previous few decades but the world never was confronted with what we have now with HIV/AIDS so that's a truly new emerging infection.


We also have what's called reemerging infections, infections that have been there historically for a very long time but they reemerge either in a different form or a different location. Let me give you one for a different form, drug-resistant malaria. We went for years being able to easily treat malaria and then drug resistance comes along; multiple, extensive drug-resistant tuberculosis. Even some of our hospital acquired staphylococcus, enterococcus that are now drug resistant.


Then there's one that has been around a long time but not in our backyard. A classic example of that is West Nile Virus, which was in the Middle East and in Africa for centuries and only within the last couple of decades has come to the United States. That's a reemerging infectious disease. There are a number of other examples of that and that's that kind of not a surprise but the unexpected.


Michael Keegan: What are the strategic priorities of NIAID? We will ask Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases when our conversation continues on The Business of Government Hour.  


Welcome back to The Business of Government Hour. I'm Michael Keegan, your host, and our guest today is Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases.  


For more than six decades, scientists supported by NIAID have been at the forefront of important research in infectious and immune mediated diseases. To that end, Dr. Fauci, I'd like to explore your strategic vision for the Institute. Would you briefly identify your core strategic priorities and how do they relate to the four main scientific areas of emphasis?


Dr. Anthony Fauci: So, we've divided up the four major areas of emphasis of NIAID into:  HIV/AIDS, infectious diseases other than HIV/AIDS (which include the standard established infections), emerging and reemerging infections and even bio-defense, such as having defense against anthrax or other attacks. That's the second.


The third is basic and clinical research in the immune system; understanding how it works, diseases of aberrant function of the immune system or deficiency of the immune system. And the fourth area is global health, so the vision of where we want to go with that. HIV/AIDS after 3+ decades now of a devastating pandemic, we have the scientific basis now with prevention modalities and treatment that's highly effective and a quest (but not yet accomplished) towards a vaccine.


We feel we can turn around the trajectory of the pandemic so that the vision is that within a reasonable period of time, we'll see an AIDS free generation. By that we mean, the tipping point where the number of new infections is less than the number of people who are put on therapy and the deflection of the pandemic starts  to go down, as opposed to what it’s been doing for a few decades is going up. So, that's a vision there.


The vision for emerging and reemerging infectious diseases is to develop what we call platforms of vaccines and drugs where we don't have to keep chasing after each individual new emerging and reemerging drug, that we have capabilities of being able to rapidly sequence, of being able to develop what we call platforms for vaccines and therapies that would be more universal rather than trying to chase after everything that might emerge.


With regard to immunology, it’s just fundamental good sound basic research to understand the mechanisms of immune function and how we might suppress aberrant mechanisms and enhance deficient mechanisms.


And then the last one is global health. We know now, and we've realized it for quite a while, that we live in a global community. So, the idea that there are diseases that we worry about and there are diseases that other people worry about is just an antiquated concept. Right now we live economically from a strategic standpoint, from a political standpoint, from a security standpoint; we live in a global community. So, global health, be it AIDS in Africa or malaria in the Far East, or other diseases, dengue in South America, are all things that we're interested in because we have to function in a global community.


Michael Keegan: I'd like to tackle infectious diseases and understand there are certain characteristics of infectious diseases that set them apart from other human diseases. Could you explain what they are and perhaps give us a broad category of infectious diseases?


Dr. Anthony Fauci: Well okay, so if you look at infectious diseases, they do have a number of unique characteristics. One of the most important of which is that if you look evolutionarily how a human develops over millennia, if you look at how evolution brings you from a situation where you have skills or not and then you develop them over thousands of years, microbes have the capability through mutations of changing characteristics in minutes to days because of their replication capability. So, we replicate every 18 to 27 years.


Microbes, like HIV, replicate thousands of times per day. And when you replicate, you have the risk of there being a mutation now that mutation may have no effect on your function or it might have a significant effect on your ability to spread from one person to another, on your ability or not to be virulent, namely to make someone really sick.


So, when you're talking about infectious diseases, it’s a constant evolution. You have a disease. It spreads. You develop a drug. You treat a person, and then all of a sudden after a period of years, the virus or the bacteria develops resistance and you have to come in with another drug, so it isn't an open and shut case. We've dealt with that problem. It’s a constant, dynamic, emerging world of microbes that we'll never completely for sure wipe out the human species but it constantly is adapting itself to its own survival.


So, when you think of infectious diseases, it’s a mysterious and in many respects wonderful world of evolving viruses and bacteria and others. It's something that we need to stay a step ahead of when we think in terms of how we intervene with therapies or vaccines or diagnostics. It’s different in many respects from diseases that have a relatively stable profile. This isn't a particularly stable profile. It's constantly changing.


Michael Keegan: Are there broad categories associated with it?


Dr. Anthony Fauci: Yeah, well I tend to think of major categories of infectious diseases as established disease. By established disease I mean I could talk to you today and predict next year how many people will get sick and how many people will die. You can generally do that with tuberculosis, with malaria, with diarrheal diseases, with respiratory diseases and even now after three decades with HIV/AIDS.


Then there are the surprises that you spoke about, the emerging and reemerging infectious disease. Are we going to have a pandemic of influenza next year or not? In the 20th century, we had three pandemics; 1918, 1957, and 1968. In the 21st century, we had one in 2009. Thank goodness it was relatively mild but it was still a pandemic so if you want to categorize infectious diseases, you can categorize them into what's established, which still is a challenge to do something about them because we really need to address these established diseases. And there's the completely unpredictable emerging and reemerging infectious diseases.


Michael Keegan: And I want to touch now on as 30 years you've alluded to of research into basic and applied and HIV/AIDS. What's happening to-date? What are the new protocols? Can you tell us a little bit about the therapeutics that are available now and then down the road, is there potential for a vaccine?


Dr. Anthony Fauci: Well, HIV/AIDS I believe is really a classic textbook case of how you go from a completely mysterious, virtually uniformly fatal disease that's transmissible, involving potentially and in reality tens of millions of people.  How you go from not even knowing what the agent is in 1981, 1982 and 1983 when the agent was discovered and then fast forward 30 years to where we are today. We now have therapies, which when I was taking care of HIV infected individuals in the mid-80s and early 90s, the median survival of my patients was 6 to 8 months which means that 50 percent of the patients would be dead in 6 to 8 months which is horrible.


There's almost no disease that's that bad and yet by taking fundamental basic research, understanding the replication cycle, targeting the vulnerable components of that replication cycle and designing drugs that we now have more than 30 FDA approved anti-retroviral drugs which when used in combination and given to a person who is like 25 years old and recently infected, unlike what I faced in the 80s when there was a 6 to 8 month median survival.


Now, if I put someone on drugs, the triple combinations which are available, I can look that person in the eye and tell them that I could predict that they would likely live an additional 50 years. There's almost nothing in biomedical research and health that's as dramatic a turnaround over a 30 year period as that. That's treatment.


We have good ways of prevention; some that are low tech (condom use, needle exchange, behavior modification) and some that require medical intervention (treating mothers to prevent transmission to a baby at the time of birth and through breastfeeding, circumcision, preexposure prophylaxis, etc).


The real holy grail that we're waiting on now in a sense, not waiting, we're actively pursuing, is the development of a vaccine and then hopefully, the aspirational issue of can we cure people. Right now, you can dramatically turn around someone's prognosis by treating them with anti-retroviral drug but they have to be on drugs for the rest of their lives.


The question is can we cure people? Can we get to the point where you suppress the virus enough that you could stop the drug and the virus won't rebound? I don't know if we're going to be able to get there but it’s certainly an aspiration worth trying. The real holy grail of turning the epidemic around is getting an HIV vaccine and I would say over the last two to two and a half, three years the advances in understanding, the light at the end of the tunnel for vaccine, is much more than what we had seen in the previous 15 to 20 years. So, I don't know when we're going to get a vaccine but the last couple of years have been very, very encouraging about that direction.


Michael Keegan: I'd like to turn to what was considered an ancient scourge of TB, tuberculosis. What are you doing and what are your efforts doing to bring the fight against and treatment and diagnosis of TB with modern therapeutics? How does synthetic biology factor into this?


Dr. Anthony Fauci: Well, that's an excellent question. Tuberculosis is one of those diseases of enduring global health impact that has really been neglected; likely because of a good dose of complacency that it’s somebody else's problem, not the developed world’s problem.


If the numbers were known by many people, they would be shocked. One-third of the world's population is infected latently with tuberculosis. That's over two billion people. They're not sick but they have latent TB. Yet there are about eight million new cases a year and about 1.3 million deaths per year of tuberculosis.


The goal of what we're trying to do at NIAID and what other organizations are trying to do to fight TB and stop TB is to bring the science of tuberculosis into the 21st century. It's almost as if we were stuck in the mid and early 20th century. We haven't had, except for one exception, a new drug for tuberculosis in over 40 years. Just this past year, we had the first drug that was specifically approved only for TB.


We have a very ineffective tuberculosis vaccine. We need a good one that works. We have diagnostics that are antiquated, that are still the ones that were used 75 to 100 years ago looking in a microscopic for tuberculosis. We don't have enough drugs. We have drugs that require six months to a year of therapy in order to suppress it.


We need to play serious catch-up ball by bringing the science of tuberculosis into the 21st century, and we're doing that by aggressively applying many of the modern techniques. For example, the ability to rapidly sequence strains of TB and identify vulnerable parts of that microbacteria that are vulnerable to drugs, parts that code for antigens that might be used for a vaccine, ways of not only diagnosing TB but determining at the point of care virtually immediately whether you're dealing with a resistant tuberculosis or not.


These are things that are getting a major, major push and it’s only been, I would say, over the last 10 years at the most that we have really come to the realization that we have to stop playing 19-20th century baseball here and get into the ball game of modern technology.


Michael Keegan: And synthetic biology is a little bit like --


Dr. Anthony Fauci: Synthetic biology is – well, that's just one way of doing it. What that is, is you create a microbe according to your own design and you can manipulate it and look at different spots in that, but that's not necessarily integral to where we need to go with tuberculosis.


Michael Keegan: I want to dig a little deeper too because you raised a question or you asserted a number which really kind of perplexed me. Two billion people with latent TB, what triggers the latency? What takes it out of latency and activates it and how do you know that?


Dr. Anthony Fauci: Well okay, so you've asked the question that we should know the answer to but we don't know the answer to. So, if you look at the large group of people, the two billion plus who are latently infected with TB, about 10 percent of them during their lifetime will convert into active TB. If you are HIV infected and you have a compromised immune system, there's a 10 percent per year likelihood that you will develop. So, if you're an otherwise healthy person, you're going to develop active TB 10 percent over a lifetime. We don't know what those mechanisms are. We do know that when you suppress the body's immune defense mechanisms, you greatly increase the likelihood of developing active TB if you have latent TB but we don't know why that spontaneously occurs over the lifetime in 10 percent of people.


So, that's one of the things that you put your finger on is that we don't even understand the fundamental pathogenesis of tuberculosis. We don't understand the systems biology of the immune system. Why doesn't the immune system completely eradicate tuberculosis? Why do you always have a little bit that's there and latent? What is the proper immune response to protect you against acquisition of tuberculosis? We don't even know what that is.


Michael Keegan: I want to transition to malaria which remains a global health threat. I know when the typhoon hit the Philippines, unfortunately, there was real concern about outbreaks in malaria. What are you doing to respond to the global threat of malaria and what are some of the new initiatives or key pharmacologies that you're using?


Dr. Anthony Fauci: Well, malaria approaches toward control, elimination and hopefully eradication. The latter is going to be very difficult. We've accomplished the second one in several places including the United States, the developed world and even in some developing nations.


Control is easy to do but it’s elusive because we have control mechanisms. So, when you look about what are you going to do about malaria, there's an implementation of existing tools. We know that bed nets work. Indoor spraying works. Prophylaxis and treatment of pregnant women works. Good treatment of people who are in the high risk works.


The implementation of that requires political, social and national will. So, there are things that you can do that you can dramatically control and maybe even eliminate malaria without any new scientific discoveries. On the other hand, there is a deep need for scientific discoveries.


For example, first and foremost, is a vaccine. This is a killer of 670, 680,000 people a year, most of whom are African babies, generally infants, certainly children less than five years old, and yet, we don't have a vaccine that works in these individuals.


Now, the reasons for that are complicated because malaria is a very complicated parasite with multiple phases in its lifecycle. But the thing that is a major target of research effort is to develop a malaria vaccine and there have been over the last several years some optimism there with regard to vaccines that have been developed that are not ready for prime time in the sense of being highly effective but at least getting us in the right direction.


The other issue is the issue of treatment with drugs to which malaria doesn't develop resistance. Back in the old days, quinine was it. You had it. You quickly cured people with malaria, and then as is the case we were discussing before, is that microbes have this inherent capability of developing resistance by mutating and changing.


So, we have a very good drug which when used in combination, automycin derivative, we're concerned and we're starting to see inklings of this at the Cambodian Thai border, where it isn't that resistance that has developed yet but the time to get to elimination of the parasite in someone is becoming longer and longer which is the first step towards developing full blown resistance. So, we need to develop a more robust pipeline of new drugs so that when resistance occurs, we can replace the old drugs with new drugs.


And we need better vector control. I mean the old issue of spraying DDT did work but there were a lot of issues associated with that. We need better vector control. So, there are two major buckets that I look at. One is implement what you have; bed nets, indoor spraying etc., but make a scientific push for the things that we don't have; better drugs, better insect control and certainly a malaria vaccine.


Michael Keegan: Well, Dr. Fauci, I had you on about 2009 right around the time of the influenza pandemic. What's been happening? What significant progress has been made in that area?


Dr. Anthony Fauci: Well, the significant progress is one in the production of vaccines, which I don't consider very much the end game so that we don't have to rely on growing it in eggs. We now can grow it in cell lines which is an improvement in production, but in my mind, not a game-changing improvement in concept.


To me, what we need to do, and we have some example of, has been in an approved vaccine this year which is using recombinant DNA technology so that you present the body with just the important protein that you wanted to make an immune response against. But, for me and my colleagues in the field, the real goal is to develop what we call a universal influenza vaccine. And a universal influenza vaccine means that although influenzas change a bit from season to season and change a lot when you have a pandemic, the immune system makes responses against that part of the influenza which generally changes. That's why you need to get re-vaccinated each year and need a really new vaccine when there's a pandemic.


A universal flu vaccine induces a response against that component of the influenza virus that doesn't change at all or changes very little from season to season or even when you have a pandemic. And we are getting closer and closer to that goal. So, the exciting thing in influenza research that might solve the problem, not only of needing a new seasonal influenza vaccine every season, but might also protect us ahead of time against the potential for a pandemic is to develop a truly effective influenza vaccine that you may need to give once or two or three times throughout the lifetime of an individual to protect them against all strains.


Michael Keegan: So Dr. Fauci, in this regard, compelling research questions relevant to global health and pandemic preparedness include determining whether highly pathogenic viruses such as H5N1 have the ability to mutate with another influenza virus to become readily transmissible by airborne route among humans. To that end, what is the likelihood of such mutations?


Dr. Anthony Fauci: Well, you picked a concrete real example. So, what's smoldering right now in Southeast Asia is H5N1 and what's smoldering in China is H7N9. These are two viruses that are fundamentally viruses of birds that have jumped species rarely into a human but that have not developed yet or might not ever develop the capability of efficiently going from human to human.


The reason why you don't see problems right now with H5N1 or H7N9 is that it reaches a dead-end. It infects a human and it doesn't have that human infect another human and infect another human and then you have what we call sustained transmissibility. There's not sustained transmissibility. However, we do know from experience that there are certain types of mutations that are associated with an increased capability of enhanced transmissibility from person to person and that's what's being followed and being studied.


Now, it isn't as simple as some people might make it where one mutation means all of a sudden it’s going to be highly transmissible. It’s likely a multigenic phenomenon that requires host adaptability that goes well beyond a mutation. So, the answer to your question is it is certainly possible that these viruses will mutate and adapt themselves better to transmissibility in human. For that reason, we've made a vaccine against the H5N1 and we're making a vaccine against the H7N9 just in case. But you asked, is it likely to happen?


Historically, you'd have to say it’s unlikely but when I say that, people will say how can you say it’s unlikely? You never know and the answer is you're right because if there's anything about influenza that you can predict is its unpredictability.


But historically, given the number of viruses, particularly bird viruses that are out there, pig viruses that are out there, that intermittently infect humans and never make the transition to sustained transmissibility among humans, you can say that the chance of that happening is probably low, but certainly not zero, and that's the reason why you have to continually be prepared to address a pandemic.


Michael Keegan: What has been learned about emerging and reemerging infectious diseases? We will ask Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases when our conversation continues on The Business of Government Hour.


Welcome back to The Business of Government Hour. I'm Michael Keegan, your host, and our guest today is Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases.


So, I want to talk about emerging infectious diseases and I think we're on the 21st anniversary of the landmark institute of medicine report on this. Can you tell us a little bit about, what are the determinants of emergent and reemergent diseases and would you define the two major categories of emerging infectious diseases?


Dr. Anthony Fauci: Okay, so the determinants are its adaptability to one, infect a human and two, importantly, sustain the transmissibility among human. Because if you look at new emerging infections, an interesting 70+ percent are what we call zoonotic, that means they originate in an animal, jump species, and go to a human. Influenza is one of them. HIV is another one of them. You can just go on and on. They start off in an animal and they go to human. Some of them are just curiosity. They jump, they infect a few people and they dead-end, and every once in a while, you get something like HIV which is a transforming global health phenomenon.


So, given that as a background, the kinds of emerging infections are one that is truly newly emerging and one that is reemerging. So, a truly newly emerging infectious disease is HIV/AIDS for sure. Nippa virus was another one of them. Influenza is interesting because influenza is both an emerging and reemerging. It’s reemerging when each year it changes a little and you need a different seasonal flu. It’s newly emerging when you get a brand new pandemic with a virus that you've never seen another like it before. So, that's the one that bridges that chiasm between truly newly emerging and reemerging. 


Michael Keegan: I was wondering what's been learned since that report. Where are some successes and failures about emerging infectious diseases?


Dr. Anthony Fauci: Well, I wouldn't call it a failure. I would say a persistent challenge is the unpredictability of it. I mean that we get -- that's why when you ask am I surprised I say I'm not surprised because it’s something that is unexpected but it’s not a surprise. Even though it sounds inherently contradictory, it isn't.


So, what we've learned is that microbes do emerge. Pandemics do occur. We also learned that the way that you can get ahead of the game is by having good surveillance in the field so that you don't learn about it when you're sitting in Washington, D.C. or New York or London and all of a sudden there are a whole bunch of people who are infected and you find out they got infected by something that originated in the Far East or some other place where you have generally the incubators for these things.


So, you need point of care in the field surveillance, diagnostics and the capability of rapidly responding with a development of a vaccine or another intervention. We've gotten better at that. We really have. I mean, if you look at what we do now about rapidly getting vaccines for different emerging infections, rapidly detecting things like the Mursa Corona virus, or the SARS virus, even though it’s a significant and rather serious challenge, I think if you compare the capabilities diagnostically, vaccine and otherwise, that we had a couple decades ago with what we have now, we definitely are doing better.


Michael Keegan: So Doctor, throughout our conversation you've mentioned drug resistant TB, Mursa, malaria. All antibiotics, anti-viral drugs share an inherent weakness/ could you tell us what that weakness is and then what are you doing to combat that consequence of drug resistance?


Dr. Anthony Fauci: Well, the weakness if you want to call it a weakness, it’s almost a fact of life that microbes because of their replicative and mutational capability adapt to whatever you throw at them; environmentally, drug wise, immune system, what have you. So, when you get an antibiotic or an anti-viral and you treat someone, unless you completely eliminate that bacteria or that virus, you will naturally select for the mutation that is resistant to getting killed.


So, if you look at a virus, let's say you are infected with a virus, HIV, influenza, what have you, or a bacteria, it isn't one homogenous microbe. It’s a microbe what we call quasi-species. There's a dominant component and a minor component so when you treat and you treat the sensitive component and there's a mutation to become resistant. At the end of the day, if you're treating, you're going to be left with the resistant microbe and that's what the microbe does to escape the antibiotic.


And that's the reason why you hear a lot about it, and it’s true, if you're going to use an antibiotic, you should use it appropriately. If you use it when you don't need it, you will inadvertently select for resistant microbes. So, the overuse and inappropriate use of antibiotics is a sure fire way to help the microbe select for resistance.


The other is, you need good diagnostic and hospital control practices because much of the antibiotic resistance that we see challenging us now certainly in the United States is things that take place in the hospital where people are there for long periods of time, they have weakened immune systems and they have a lot of antibiotics because they have complications. When you develop a resistant microbe at a hospital, you need good infection control processes to prevent the spread from one person to another so that you can keep it dead-ended in the person who gets it and hopefully successfully treat that person.


So, it’s an inevitability of the interaction between the human host use of antibiotics and antivirals to suppress the virus or the bacteria. The virus and the bacteria have inherent, replicative and mutational capability to avoid the bad things you're trying to do to them, namely kill them.


Michael Keegan: I'd like to turn to the allergy side of your portfolio and in particular the immune mediated disorders that you deal with like asthma, type II diabetes. Would you elaborate on this research and more importantly, what advances have been made in understanding the pathogenesis of immune mediated diseases and the strategies to prevent and treat them?


Dr. Anthony Fauci: Okay, so if you look at immune mediated diseases in two major buckets. One, that's an inappropriate or aberrant function of the immune system which directs itself against self, and that's why we call it autoimmunity because you're making an immune response not against a microbe that you're trying to kill. You're making it against your kidney or your liver or your brain or your skin or what have you. That's one type of an immune mediated disease.


Another is an immune deficiency, congenital or iatrogenic, namely caused by physicians or some medication. So, what we have been doing is trying to understand in the immunodeficient person who is congenitally immunodeficient. There's been a lot of advances in gene therapy where if it’s a genetic basis of the immunodeficiency, you might be able to replace or replenish the defective gene. You don't have to do it completely, maybe just enough to get that person to being able to function.


And some of the classic but rare immunodeficiencies, gene therapy has been successful. In fact, one of the most successful arenas of any gene therapy is in reconstituting immunodeficient children mostly.


The other larger field numerically is autoimmune diseases and one of the most exciting approaches is what we call the induction of tolerance. Tolerance means that the immune system sees itself as different and would naturally want to make a response to get rid of it, just like it would want to get rid of a microbe. By tolerizing it, the word tolerant, you become tolerant to it, so you train the immune system instead of responding against it, you recognize it but you don't respond. You're tolerant of it and that's what's referred to as the induction of tolerance.


That's a major area of research in autoimmunity that is showing some success even for example with transplantation where you give someone an organ transplant and you don't necessarily have to treat them with immunosuppressive drugs to prevent the rejection of that transplant. You can try and tolerize them to recognize the transplant as different but not reacting against it. 


Michael Keegan: That's fascinating. So I want to talk to another part of your mission which is bioterrorism defense. What are you doing in that area and more particularly, how is the research evolved since say 2001 from a one drug, one bug kind of approach to more flexible strategy?


Dr. Anthony Fauci: Well, that has been an evolution in strategy and the evolution was after the anthrax attack which came literally right on the heels of the 911 attack in New York City and the Pentagon and in Pennsylvania; there was an anthrax release, which we didn't know what it was at the time. But historically, when you look at some of the stockpiles that countries like the Soviet Union and their countries there had during the Cold War, the concern was that we know that anthrax was stockpiled, hemorrhagic fever was stockpiled, tularemia was stockpiled, plague was stockpiled, and small pox was stockpiled. You had to have defenses against the things you know were stockpiled.


So, in the early years following 2001 through mid-2000s, we were developing vaccines and drugs to be able to address those threats that we knew had already been produced. Hopefully never to be used but some countries stockpiled them.


Then it became very clear that the potential for the use or misuse of microbes in biological warfare is so enormous it’s futile to try and make an intervention against any and every single potential microbe. So, that's why we started to focus on what we call broad multi-use platforms both for vaccines and for antibiotics and antivirals, where it’s a general broad spectrum. So, you could have an antiviral that would be good against multiple different classes of viruses that you could stockpile that, instead of worrying about, “well, I have to make an antiviral against the following 50 potential agents that could be used in bioterrorism.”


So, it's been a transformation and it’s actually been good for the entire field of microbiology because it allows you to develop sustainable interventions, not only against microbes that someone might deliberately release, namely bioterrorism, but also helps you to prepare against the much, much more likely scenario: that nature itself which is clearly recognized as the smartest and best bioterrorist because if you look at the history of mankind, the evolution of microbes that have devastated civilizations are naturally occurring ones.


So, in the quest to protect and develop interventions against deliberately released microbes, we've come a long way to enhance our capability of responding to naturally occurring.


Michael Keegan: So, Dr. Fauci, could you explain for us the difference between dual use research and dual use research of concern?


Dr. Anthony Fauci: Well, it’s important to distinguish dual use research from dual use research of concern. So, whenever you're dealing with a microbe that has the potential to make someone sick, which many of them do, otherwise it’s unlikely that you'd be studying it so intensively, and you're manipulating the microbe, you want to see how it acts in culture. You want to manipulate it. You want to look at it under different circumstances. By definition, that's dual use research.


It becomes dual use research of concern if you're dealing with a microbe that is of the characteristic that it could easily cause a public health disaster. Either we don't have good drugs or we don't have good vaccines or the technology could be used by a nefarious person to create difficulties by releasing such a microbe.


So, the way you get around that is that you have good training of people who are doing it, that you have facilities that are able to ensure the safety of the researcher as well as the safety of the community around which the lab is located. But most importantly, you generate what we call a culture of responsibility so that the chances of there being an accident and someone inadvertently causing a problem by working with a dual use research of concern microbe is infinitely greater than someone deliberately doing something to cause a problem.


It's almost as if you really can't absolutely, 100 percent stop the bad guy. You can just make it much more difficult for them to do that. But one of the things you have to be careful of is not the bad guy. It’s somebody who is trying to do a good job but is either not well trained, is not in the right facility, doesn't have the right qualifications. So, when you ask what we can do, we can do a lot to generate a culture of responsibility and make sure that the people that work with these microbes know what they're doing.


Michael Keegan: I'd like to touch on that because it gets to my other question which is how are you promoting the highest level of scientific integrity, public accountability, and social responsibility in the work that either you fund or do?


Dr. Anthony Fauci: Well, that's an important part of our process of vetting. That's an important part when someone comes in with a proposal. You want to make sure that it’s done in a way where it’s very, very clear and by promoting it, you're out there. You're talking about it, and when you have conferences, when you meet in working groups, you talk about the inherent responsibility as a scientist whose life is devoted to doing good for the public health. You have to make sure that's what you're doing. And that's what I talk about when I say the culture of responsibility. You just create an environment and an atmosphere where people naturally gravitate to that.


Michael Keegan: What does the future hold for the National Institute of Allergy and Infectious Diseases? We will ask its Director, Dr. Anthony Fauci when our conversation continues on The Business of Government Hour.


Welcome back to The Business of Government Hour. I'm Michael Keegan, your host, and our guest today is Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases.


Well, I want to touch, you've commented on this a couple of times today about the global aspects of your mission and I'd like to understand what are your four core principles around guiding your international portfolio and responsibilities?


Dr. Anthony Fauci: Well, there are a number of core principles and they're very important. The first is that when you're dealing with a foreign country which is usually a developing nation of low and middle income that you must do your experiments with the highest degree of ethical guidelines and ethical considerations. That's point number one.


Point number two is you have to engage in a true partnership with the country. It can't be paternalistic where you come in and you tell them what's good for them. You have to have a partnership. That's the other one.


The third is that you must conduct research whose ultimate goal is the benefit of the people on whom you are doing the research. So, to go into a foreign country and do the kind of research that would ultimately be of no benefit to them but would be of benefit to you back home because they unlikely would ever be able to either afford or wouldn't apply to their population would be unethical. So, it'd have to be to the benefit of the group.


And the other, you have to be very transparent and share information so that if you do research in a country, you have to make all of the information totally available to those people who participated in that.


Michael Keegan: I often talk to my guests about the importance of collaboration and partnerships in achieving mission outcomes. How are you leveraging partnerships in improving your outcomes and operations?


Dr. Anthony Fauci: Well, we have a number of partnerships both within the federal government and outside the federal government. I'll give you some examples. We very closely collaborate and partner with the Center for Disease Control in Prevention, the CDC and The Food and Drug Administration, the FDA.


Many collaborations with the Department of State, for example, the (ph) PEPFA Program. We collaborate with the Department of Homeland Security with the biodefense. We collaborate with the Department of Defense because a lot of the vaccines we make are important for the troops. So, you're talking about a whole number of different departments, USAID, others that we collaborate with.


Then when you get outside of the federal government, we collaborate with organizations like the Bill and Melinda Gates Foundation, the Clinton Foundation, (ph) METS Ason Frontia, Doctors Without Borders, and others, various stop TB programs and malaria programs.


And the importance of that collaboration is that it really provides for what we call a synergy of ideas because if you go it alone, you really deprive yourself of the expertise and the perspective of others who come from it from a different angle. That's the reason why we very much embrace these kinds of collaborations because it’s good for everyone.  


Michael Keegan: So Doctor, what technological advancement or new use of scientific technology has made your mission either more effective or easier? And what are some of the risks and benefits of these things?  


Dr. Anthony Fauci: Well, from the standpoint of infectious diseases, I think that there are a number of technologies. Let me just pick out one that is really transforming and that is the ability to rapidly sequence microbes, the genome of microbes. When I say rapidly I'm saying that the first microbe that was sequenced decades ago took about a year and about 40 million dollars to do.


We can do it in a few hours for a couple dollars now. It's just breathtaking what you can do. We refer to it as next generation sequencing, NGS, or deep sequencing where you could take a quasi-species of viruses and sequence every single one of them and know the signatures of resistance, the signatures of transmissibility, the signatures of pathogenesis. We were not able to do that year's ago. We can do it now in any really good university type laboratory.


That, to me, is the application of the capabilities of genomics, proteomics, informatics, and by informatics we mean the ability to process all of this amazing amount of data that you collect that no human could sit down and decipher. You need people who really know their way around informatic computerization of data to be able to give you the answer. To me, that has been technically the most transforming advance that we've been able to make.


Michael Keegan: Fascinating. Could you give us an example of how? If you speed up the understanding of the microbe and genomics of the microbe, what exactly are the benefits in basic research?


Dr. Anthony Fauci: Well, the benefits, first of all, in basic research are to understand how the microbe works, all the genetic determinants of all of its functions. You get a genotype and then it’s what is called phenotype. Genotype is what the genes are; phenotype is how it acts, what it does. And to be able to make that correlation between genotype and phenotype instantaneously as opposed to waiting is phenomenal from a basic research standpoint.


From an applied research standpoint, it’s actually breathtaking. So, you could come in and have a disease that you know its RNA or DNA, it’s a virus. You don't know what it is. You could assemble and doing sequence and by computational biology figure out from nothing literally from a specimen what it is. Is it a virus? If it is, what's the class of virus? Is there when you go to your database is there a virus that absolutely matches this? If it is, we already know what it is and if there isn't any, then wow, we're dealing with a brand new virus.


Once you get it and sequence it, you can actually create it and then wind up manipulating it. You could target drugs against it. You could find out what the proteins that it expresses are that might be used as a vaccine candidate. You can do diagnostics against it. These are things that are done almost instantaneously that years ago took months if not a year or longer to do.


Michael Keegan: So Dr. Fauci, as we focus on the future, close our conversation today, what are some of the major opportunities and challenges you think your organization will face and how will you address them?  


Dr. Anthony Fauci: Well, I think the opportunities are like in any area of science that we are in an arena of extraordinary breathtaking opportunities in science. From my own standpoint, from infectious diseases and immunology of being able to unlock the intricacies and the secrets of the immune system and how you might control it when it’s aberrant and supplement it or implement it when it’s deficient.


With regard to microbes, the challenge of the ability to be able to be prepared for any emerging infectious disease as well as to look at the existing disease and actually be able to think beyond just an aspiration but actually a realistic goal of sending HIV/AIDS, malaria and tuberculosis down the route that we did with small pox, essentially get rid of it, that we're on our way with polio, which we're almost there. We had a setback when certain countries decided to stop vaccination but hopefully we're back on track. Those are the opportunities and the challenges.


One of the things that we are concerned about is that despite these extraordinary opportunities that we're in an arena of constrained resources where science is considered a discretionary component of the budget. I personally don't think science should be a discretionary component of the budget. It should be a mandatory component of what we do and not a discretionary component.


And then you have to worry about the anti-science culture that is around sometimes. People don't believe that science is going to help you, as opposed to what is so clear that science is the route to discovery which is the route to better living, both from the standpoint of health as well as economics. 


Michael Keegan: So what advice would you give someone who is thinking about perhaps a career in public service or medicine or both?


Dr. Anthony Fauci: Well, the advice I would give them would be that if that's something you have an interest in then pursue it and don't let anything get in the way of pursuing it because the gratification that you get out of public service and helping people, particularly in the arena of discovery with all of the excitement of discovering something new.


If you're not a basic scientist but you just want to be a person who is a public health person, either a physician or a nurse or a healthcare deliverer, there's nothing that feels better than making someone feel better in the sense of alleviating pain and suffering, prolonging life in a meaningful way, that's something that you just can't get anywhere. It’s just there, and for some people to make that their career, I would suggest if you even have the slightest interest in that, that's a very gratifying career.


Michael Keegan: Well, Dr. Fauci, I want to thank you for taking time out of your busy schedule to join me today. It’s great to have you back but more importantly I'd like to thank you for your dedicated service to the country.  


Dr. Anthony Fauci: Thank you very much. I appreciate that.


Michael Keegan: Great. This has been The Business of Government Hour featuring a conversation with Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Disease.


Be sure to join us next week for another informative, insightful, and in-depth conversation on improving government effectiveness. For The Business of Government Hour, I’m Michael Keegan, and thanks for joining us.




Dr. Anthony Fauci
What are the strategic priorities of the National Institute of Allergy and Infectious Diseases? What has been learned about emerging and re-emerging infectious diseases? What’s on the horizon for the NIAID? Join host Michael Keegan as he explore these questions and more with Dr. Anthony Fauci, director, NIAID.

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