Transcripts For CSPAN National Institutes Of Health Fiscal Year 2016 Budget Request 20150307

Muttonjeff combination. He was very robust, terrific and natural athlete. Madison is a skinny little guy. This sunday on q a, the founding father James Madison and the success he made in our nation. The gift i like most about is his ability to perform to reform relationships with the great people of his era and it also opens to his gift to the country of his talents and what he was able to do to help create the first selfsustaining constitutional republic. Sunday night at 8 00 eastern and pacific on cspans q a. On tuesday, a House Appropriations subcommittee on the national health. The other National Institute leadership on president obamas fiscal year 2016 mih budget request. Visit two hours. This is two hours. Good morning. It is my pleasure to welcome you to the subcommittee on labor health, human services, and education to discuss the fiscal year 2016 National Institutes of Health Budget request. We are looking forward to hearing the testimony of dr. Collins and some of his distinguished colleagues. I would like to publicly thank dr. Collins and the staff at nih for hosting me and five other subcommittee members for a tour of the nih campus a few weeks ago. I think it is safe to say we all left the nih with a deeper appreciation to the exciting work your staff do every day to find ways to save lives. The scope of Biomedical Research supported through and at the nih is wide and we are confident that thanks to the talented staff and scientists who work there, will one day find cures for diseases like cancer and alltime worst. Ensuring a significant search base and supporting the next generation of researchers it is critical to pave the way for these longterm advancements. Your budget assumes many areas of enhanced spending on genomic activity, including a focus on ebola flu vaccine, and a biotic resistance, and alzheimers research, to list only a few. Of course, we all support Biomedical Research. Unfortunately, and sequesters law of the land and given the reality of funding allocations we might not be able to do everything that the administration has proposed on a larger bipartisan agreement. One, i hope we achieved. I look forward to having a discussion with you this morning on your Top Priorities for this year, given our funding constraints. We know how long it takes for a new drug or treatment to make it from lab to patient. Without a pipeline of young researchers committed to the scientific process of investigation and instrumentation, we will not be able to find the cures that we need. Today, we welcome Francis Collins to the subcommittee. Collins is accompanied by five members. They are anthony foxx she fauci. Dr. Thomas insel. Dr. Nora volkow. We will abide by the fiveminute rule. Before we began, i want to yield to my chairman. Then we will move to the Ranking Members. The gentlelady from connecticut and from new york. With that, mr. Chairman, you are recognized. Mr. Chairman, thank you very much. Congratulations of being the new chairman on this great subcommittee and the responsibly that you have gladly taken on. Welcome to all of you for being here. Dr. Collins, your leadership role and the groundbreaking human genome project is just one example of your many talents. Im told that another one of your talents is playing guitar. Apparently. Family very well. So you have something to fall back on in case this doesnt work out. [laughter] unquestionably, you all are at the helm of research at the nih during a time that demands our country interest and investment in medical research. The recent ebola epidemic in west africa highlights the importance of nihs mission to Gain Knowledge to enhance life and reduce illness. Medical research is why the most important parts of preventing future epidemics. And about cures for diseases that are not preventable. The nih fiscal 2016 request highlights priorities such as ebola, alzheimers disease, and microbial resistance. In addition to the Public Health is it, the Economic Impact of medical research should not be underestimated. Nih Research Dollars not only Impact Research and facilities and researchers, but they also lead to new drugs and devices. I am pleased that you have seen fit to invite dr. Nora volokow. As the director of the National Institute on drug abuse, dr. Vok has been a true pioneer. She is beeno onew of the first people in history to use brain imaging. Her research has undoubtedly made the world that we live in a much greater place. She has been with us since day one as we battle drug abuse in my area, in southern and eastern kentucky. Hardhit especially by oxycontin and others. Im looking forward to seeing both of you, in fact, at the atlanta summit on Prescription Drug abuse this summer. I thank you for coming last year and helping us battle this restriction drug abuse scare that is killing more americans in car wrecks. We appreciate your dedication to the especially. We look forward to hearing, also from you today about two critical drugrelated issues. First, i am pleased that dr. Vo lkow is pursuing a study to collect rigorous longitudinal data on the fx of marijuana alcohol, nicotine, and other drugs on a Young Persons brain. Its unfathomable, to me, that states continue to pursue policies to decriminalize or legalize marijuana. Even here in the nations capital. Its ironic that in washington dc, the nations capital, you cant Smoke Cigarettes but you can still thought. Explain that to me. Help me out. We dont have Scientific Data to tell us about the longterm impact of marijuana use on the brain. Hopefully this will open a lot of minds. This study will hope close that gap, hopefully bring some muchneeded sense to the conversation about marijuana abuse in this country. Secondly im interested to hear about recent efforts regarding the abuse of prescription medications. As you well know, thats been characterized by your colleagues at cdc as a national epidemic. I understand that youre partnering with nine Major Pharmaceutical Companies to evaluate the risks associated with longterm use of opiates for the management of chronic pain. If there are nonob alternatives not obnopiate alternative we need to know about them. Its a remarkable the oxycontin a job drugs that cause so much difficulty, mostly five to six years ago the drug was changed to make it drug abuse deterrent. You cant crush it, snorted, or injected. It still retains though, the good qualities of relieving pain for an extended. Period. Thats what can be done to stem the use of opiates. I commend you for it. In addition to her longstanding struggles with drug of addiction and abuse, the research provided by nih is critical for creating cures for a home is like diabetes, cancer and Heart Disease that continue to plague my region especially. We are very proud of the partnerships we have established with nih in kentucky for example, the marquis Cancer Center. The Cancer Center at the mercy of kentucky. And the center for clinical and translational science, which previously received your award. For his works to confront Chronic Health issues in kentucky, especially in the appalachian region. Currently, 52 of the top ranked universities for Life Sciences are in the u. S. We must continue to foster the next generation of scientists. We look forward to continuing these collaborative efforts as we Work Together to bring an end to these devastating diseases. We thank you for being here. With your colleagues, dr. Collins, we expect to hear some good stuff. I yield. Thank you, mr. Chairman. Next we will go to the distinguished lady from ke connecticut. Thank you, mr. Chairman. Good morning to everyone. It is such an important topic that it was important to all of us to have the opportunity to have a full two hours with this thing was panel. Im so thrilled to welcome dr. Collins. First and foremost, let me say thank you for your work. Every scientific discovery every medical breakthrough improves the quality of our lives and most of all, it saves lives. As an almost 30 years survivor of overturning of ovarian cancer, i am alive today due to the grace of god and scientific research. When i was elected, i made that research one of my Top Priorities. As well as improving health research, it also drives are economy. Every dollar invested in nih repays that in economic growth. It employs more than 7 million americans and adds almost 70 billion to our gdp. In january of this year, along with the chairman, i had the pleasure of joined the nih and along with other members of the subcommittee. It was, as always, a fascinating visit. While there, we met a senior investigator who was largely responsible for one of the ebola Clinical Trials. That is only possible thanks to nih support. Dr. Solomon, and her colleagues, have been able to pursue a vaccine over many years. Since 1997, in fact. If we do not invest now, we will not be able to benefit from scientific discoveries, 5, 10, even 20 years from now. It is troubling to me, deeply troubling to know that since 2010, nih has seen its budget a road by about 3. 6 billion. That is an 11 cut. Sequestration is terrible policy for any budget. It is especially cool where there are literally lives at stake. In 2013, sequestration to 1. 5 billion from the nih. Even after modest increases over the past two years, we have not returned nih cost budget to pre sequestration levels. One decade ago, nih was able to find one in three applications for grants. That has fallen to one and six. A two thousand 15, nih will find almost 1000 fewer Research Projects than it did in 2010. We will never know how many scientific discoveries and medical breakthroughs the world may have missed out on because of budget restraints. That is a disturbing context in which we consider the nih budget requests for what fiscal year 2016. Overall, this budget starts to set us back on track. There are exciting initiatives in this budget. Combating antibiotic initiative defendants are against deadly superbugs. The brain holds the potential to revolutionize no science and make advances in treating alzheimers and autism. The budget includes funding for research on a universal flu vaccine, and potentially, a cure for hivaids. It also supports basic Science Research that has longterm benefits across multiple fields. As i said, i believe this is the right track. Given the severe neglect of nih over the past two years, ive disappointed that we are not restoring funding more quickly. This budget address is one third of the cuts. I introduced a bill in last congress, and again in this congress that would allow our committee to increase funding by this 10 this year, and over the next few years. We have invested strongly in nih before. In the 1990s, i was among a Bipartisan Group of members of both chambers on this committee who fought to double nihs budget over five years. To this day, it stands out among my most proud achievements. Instead of starving the nih of funds, we should be seeking to repeat that achievement and double is budget again. This cannot happen unless we undo the failed policy of sequestration and have encouraged to ask song, the wealthy, to do more to support our national priorities. By met Biomedical Research gives us the gift of life. For me and for countless others. That is what the nih represent. We can, and must, find the resources to support it. I think you. Inc. You. Thank you. I now go to the gentlelady of new york. Thank you. It is a pleasure for me to be here today. I would really like to thank the chairman for holding this hearing today. It is such an honor for me to have such a distinguished group of public servants, the doctors. I really appreciate you being with us today. I thank you for the lifesaving work that you do every day. Throughout my time in Congress Federal funding for the National Institute of health has been among my very Top Priorities. Nih is the worlds premier research institute. Its researchers have mapped the human genome. I do remember dr. Collins, that empty shape the you filled up it is really amazing. You have created vaccines that are being tested to prevent the spread of a bolla, ebola, reduce death rates by 60 over the last century, and invested in hiv therapies that turned what used to be that sentences and to longer, more productive lives. As a result, it is no surprise, but it continues to amaze me, that nihsupported scientists have been awarded no less than 145 nobel prizes. Not only does nih work and improve the life of americans it is also a springboard for economic growth. I remind my friends and neighbors all the time that not only are you moving ahead and saving lives, but you are creating jobs. Your 2016 budget request proposes an increase of 1 billion, resulting in 1200 Additional Research grants. It would make welcome investments in advance cancer treatment, Precision Medicine, increase funding for the Brain Initiative, develop treatment to combat alzheimers, autism, and other neurological and psychiatric conditions. These are the very definitions of worthy federal investment. The president has also called for the end of the mindless austerity of sequestration. In fact, i have even heard some of my colleagues on the other side of the aisle referred to the mindless austerity of sequestration, urging congress to replace it with more targeted spending cuts, Program Integrity measures, closure of some outdated tax loopholes. I cannot agree with him more. The effects of sequestration are immense and still being felt. A 2013 alone sequestration reduced nih investments by 1. 5 billion. Thats why 2015 funding is still below the three c kuester level. Many critical initiatives were abruptly halted. It really was a worstcase scenario. We have to make sure it does not happen again. The United States must keep pace with the rest of the world. While nih funding is 11 to low below the 2010 level when adjusted for inflation, others have made substantial increases. Between 2007 and 2012 china increase their Public Health spending by 9 billion. Increase. We are just not keeping up. As we begin the annual process of crafting a budget resolution, i know there will be many be going viewpoints. Many of my colleagues may press for additional cuts. I think we all know how dangerous that is. Discretionary funding, which includes Biomedical Research education, job training, transportation infrastructure, and Clean Energy Development is falling to its lowest level since the eisenhower administration. We must act to ensure reasonable allocations to the important programs, and investments in the appropriations process especially the National Institutes of health and those under the jurisdiction of this subcommittee. I look forward to your testimony. Thank you again for being here before us. I look forward to nihs plans for the coming year. Thanks. Dr. Collins, your full statement will be entered into the record you are recognized for what ever introductory comments you want to make. Thank you and good morning distinguished members of the subcommittee. It is an honor to appear before you. This panel has a long history of supporting the nihs mission, to seek fundamental knowledge, lincoln life, and reduce disability. Over the last 60 years, deaths from cardiovascular disease have fallen by more than 70 . Meanwhile, cancer death rates have been dropping about 1 each year for the last 20 years. Likewise, hivaids treatments have greatly extended lives and Prevention Strategies are enabling us to envision the first aids free generation. The future of violet Biomedical Research has never been brighter. Allow me to tell you about just some of the few initiatives that we are pursuing. Lets start with vaccines. Thanks to nih research, to vaccines against ebola are being tested right now in l libya. Currently, a new flu vaccine must be created each year. That approach is not ideal, as we saw this last season. Nih is working to make a universal flu vaccine against virtually all flu vaccines. Such a vaccine could reduce the need for an annual flu vaccine. Universal flu vaccine candidates have now moved into Clinical Trials. Nih commi remains committed to fundamental research. One exciting example is the Brain Initiative. This bold, multi Agency Effort is enabling innovative technologies, you see one here, to produce a clear and more dynamic picture of how brain cells interact in time and space. This initiative will get less mental tool in major brain advances. From alzheimers, autism, schizophrenia. Scientific advances are also exhilarating progress in a new era of Precision Medicine. Doctors have had to base their treatments on the expected response of the patient. Recent advances, including the plummeting cost of dna precision, takes into account differences in jeans environments, and lifestyles. The nih takes a lead role in the multi agency precision initiative. This will focus on cancer. To accelerate efforts, this will focus on how cancer has evaded treatments, and look at new treatments, in a wide range of adult and pediatric cancers. As a longerterm goal, this initiative nih will launch a cohort of one million, or more volunteers, to play an active role in how their genetic and environmental information is used in a wide array of diseases. Theres no better time than now to embark on this enterprise to revolutionize medicine and move this precise individual approach into clinical practice. Let me share a story that highlights the early promise of Precision Medicine. When someone was diagnosed with cancer of the long, it was unexpected. She was just 36 years old, never smoked a day in her life. Her tumor was very large, as you see here, seven centimeters. With a very low likelihood of survival, she started chemotherapy, and her doctors suspected that she had a specific mutation. Genetic testing confirmed there ir hunch, and she was prescribed medicine. After three months of treatment her large tumor shrunk dramati caly. This was followed by surgery. Today, seven years after her diagnosis, her doctors can detect no signs of cancer. Whats more, during the extra time provided by this approach, she competed in a triathlon, landed a dream job as a biology professor, and welcomed and baby girl. Clearly, we need more stories like this one. With your support, we can realize our vision of exhib accelerating research to more precise approaches to treatments and cures. So, thank you, mr. Chairman. My colleagues and i now welcome your questions. They give a much, dr. Collins. We will go first to our chairman and Ranking Member, then through our normal order. Thank you, mr. Chairman. Dr. Collins dr. Volkow, thank you for your research on Prescription Drug abuse. As you know, once a day, about one in five americans die from overdose specifically prescription medicine. Sadly, as we have taken strides to address that challenge, we have also seen a rise in heroin use. Its consequences, as people are addicted to painkillers graduate to those drugs which are cheaper. I have long advocated for a multi pronged approach to address this unique challenge and of Course Research is one of the main prongs of the approach. I particularly interested in the development of new technologies that will make these drugs more difficult to abuse. Weve seen some Real Progress in that field. Affective abuse deterrent technologies that will ensure that patients truly in need of these therapies, can receive treatment, while also ensuring that these very powerful addictive medicine cannot be tampered with or abuse. Let me ask you, what investment has nih made to advance the science of abuse deterrent technologies . Can you comment on the fruits of those labors. Mr. Chairman, thank you for that question and your leadership in this area, which is really quite remarkable, the way you have shown a bright light on the importance of addressing this. I will ask dr. Bvolkow, who is an expert in this area to address the question. Thank you for the question and your interest in this matter. As you describe it, we do use a multipronged approach to address the issue of the prescription. Of drugs. If they are opiatebased, they have a deterrent formulation so that they cannot be diverted and abuse in ways that they can produce addiction and harm. Many strategies have been developed and some of them relate to a combination of drugs , others relate to inserting the drug so they cant be diverted. A Publicprivate Partnership enhances the likelihood that the drugs will get into the market. Again, here, innovation has led to different ways of solving the problem. The development of medications and strategies to prevent deaths from overdose. They are antidoes. In fact, one of them is very effective. We have again partnered with a pharmaceutical to be able to provide a in ways that are userfriendly and anyone can administer them. Thirdly, we cannot underestimate the relevance of developing medication to treat those individuals who become addicted to opiate medication. Proper treatment can prevent overdoses. In parallel, we are also working on Implementation Research to ensure that people will, and protectionist practitioners, will provide better prescription. Using what i believe is called prodrug technology, what is that . Prodrug technology is when it is not active in this case, the medication that we are working with is a pro drug that will not become active until it reaches the gastrointestinal system and at that time it is activated. Someone, if they want to inject the drug their will not be any affect. It requires the enzymes in the grass still gastrointestinal tract to activate it. What do you think about it. Go i think it is very promising. There have been test in the past the eia shows they cant prevent addiction. Dr. Vokol has taken this as a personal interest to advance. If this should be successful, this is a major breakthrough, is it not . It would be a very important breakthrough, and we hope we will be hearing soon. We are expecting some results in the new view near future. When . I am under a confidentiality agreements i cannot give details. We hope it will be soon. It is an exciting thing. Oxycontin, like many other opiates are wonderful drugs for terminally ill cancer patients. If it can be crushed and injected all of a sudden, you get a 12 hour release in a split second. Thus, the addictive power of theseis addictive drug. If you can find a way to not have its addictive use, that would be a lifesaving development. Hundreds of people a day dying from drug overdose. How can we incentivize the private Countries Companies to invest in these technologies . So that theres something in it for them . To start with, it is example of how science and politics need to Work Together. There are dollars invested into it, so we want to ensure that when you thought is on are developed when the products are developed they will be paid for. However, it is likely more expensive. That it is supported by the resources. I thank you for your work and dedication. The gentlelady from new york is recognized for whatever question she would like to pose. Thank you. Dr. Collins, the example that you gave of the woman with the growth on the long is very extraordinary. What i thought of immediately is every person who goes to the doctor with what ive heard in two cases, and operable tumors in operable tumors and her lungs, do they all get that test . That is a great question. In fact, one of the things we hope to achieve is to make that kind of experience much more available. Increasingly individuals who develop cancer are having some kind of analysis done of the tumor to see what is driving it. We are developing a long list of reasons why good cells go bad and start growing when they shouldnt, and the ability to be able in the individual, to see what is going on in that person and connected up with the appropriate choice of drugs. This targeted therapy approach is extremely exciting. And fact, for long cancer, they have started a protocol called long map which aims to do that, and another one for pediatric cancers. So far the development of these approaches and implementation across all of health care is not there yet, in part because we do not know quite enough to know that a strategy. The Precision Medicine initiative by expanding that should make this opportunity available to many more people of cancer. It should also teach us things as to why it does not work, when you think it should. I gave you an example of a remarkable here, but we do not always see that. We do not know why, when it doesnt work it what is responsible. Or when it causes remission and the disease comes back, what is that about . Another thing, with Precision Medicine initiative, we will focus on five year out if we can combine more than one target if there be, or perhaps drug therapy with immunotherapy, and have a higher likelihood of not only remission, but cure. All of these are rigpe for investigation. But it is still not widespread what you are saying. I have two friends who had in operable lung cancer, and im wondering if those tests were available to them, but youre saying it is not that widespread. Increasingly, they are. I would say, anyone who is interested, go to clinicalchild. Gov and find out clinicaltrial. Gov and find out if you are eligible. Im particularly interested in how Precision Medicine, due to the Se Initiative could Bolster Research for Breast Cancer. We arty know that white women are slightly more likely to develop cancer than africanamerican women. But after the age of 45, Breast Cancer is more likely in africanamerican women. These factors, likely evident in our are so vital. I know there are many studies because i was part of an initiative on environmental factors that never led to much, frankly. If you could share with us what breakthroughs for Breast Cancer have benefited from nih research, and how will be Precision Medicine improve finding a cure, once and for all. Thanks for the question. Breast cancer, obviously, is a major of priority for the National Cancer institute. The ability to look at thousands of breastcancer and see what is happening on the molecular level has taught us that this is not just one disease. This is many different disease with many different molecular pathways. Those have already led us to new insights about kinds of therapies that we did not know about. Obviously, the discovery of genes that play an Important Role in hereditary susceptibility play into that, but we have a long list of factors. What we really need is better means of prevention and early diagnosis and treatment. Heres, where i think again the Precision Medicine has a lot to offer. Sign next year, week of put together participants in a study that collects all the data that you could imagine about their medical experiences, their dna, their environmental exposures. We might have sufficient power to really get our hands on information that has been rather elusive about what is exactly the inner interaction between genes and environment. Electronic Health Records are becoming the norm. That will help hugely. That is becaus this i the right time to initiate a program of the sort. We maybe couldnt have done this 20 years ago, but we now can. And the willingness of the public and the enthusiasm of the public to be part of a National Effort of the sort. We could do something really groundbreaking and historic. That is what this aims to do for Breast Cancer and many other diseases. , i see the red light is on, but i just have to tell you, this is why our investment in the nis is so critical. I find information that we gather here so fascinating. We could do groundbreaking here, mr. Chairman. Thank you. I am very tough on the clock. Let me quickly, if i may, ask one question of myself. One of the areas that i know concerns you, simply concerns me, which is simply the pipeline of young researchers. I recognize, and i think my colleagues wanted out, we are not as generous as we would all like to be in terms of our appropriations to this particular institute. You have fewer grants and rewards together researchers. Your success rate goes down. I was just recently made aware of this by a good friend of mine , the president of cornell and the incoming president of the smithsonian. I asked him why he is leaving a place like cornell, and the thing he said that concerns him in the future science is this. He said, i have relatedly mounted young people, but they want to research. They want to get things done and we are giving them opportunities that they need to have. That will cost us down the road. So, i would like to know, number one, your assessment. Number two, what are things that we ought to do, what are things you are doing now engaged in the next generation of scientists, that will hopefully match the accomplishments of this distinctive panel. Thank you for the question. This is the issue that wakes me up at night. When i tried a couple of contemplate the future of where Biomedical Research can go, we have such great opportunity some of them im sure we will continue to discuss. The most fundamental element of research is the people. They are full of ideas and vision yet they are finding themselves facing a situation and that is the least supportive of that vision in 50 years. They look ahead and see Senior Scientist struggling, having rejection after rejection of grants that previously would have been supported, and anything, do we really want to sign up for that. Many of them are walking away and doing something else. Meanwhile, the rest of the world as already mentioned is picking up steam. As we seem to have lost some of our momentum. That will have really significant fx. Effects. Again, there is no magic here in solving a difficult req equation of supply and demand. We are trying to address as many things as we can. I have had many interesting conversations with people on the subcommittee about this. One of the things we are doing is trying to make sure that that first application from a new investigator gets a special effort to get funded, beyond what it may amongst people of larger experience. New investigators compete against each other. Many other institutes, on top of that, give them an additional up in likelihood of getting the cut. Of course, we do not want to set people up for the first reward to be successful, and when they come back for the second reward, we lose them. We are doing a number of other things. We are funding a program that provides support for postdoctoral fellows who are ready to go on in a couple of years for a position to compete for their award and carry part of that to an academic position. We are increasing the number of those because it seems to be a good mechanism. A number of other things are being done to free up more of a proportion of funds for more applicants. I will quickly ask one of the doctors to say things about what they are pursuing. Thank you dr. Collins, and chairman for the question. We are starting a new Pilot Program called maximizing the investigators award which improves the efficiency of our funding mechanism of, especially to young investigators. It would also have a number of targets, one would be to increase the decision. It would improve flexibility, and we think it would improve their ability to take on ambitious Research Projects. Efficiency, i think, is the key. Thank you very much. I want to move next to my friend, Ranking Member from connecticut. Thank you, mr. Chairman. Thank you. We just briefly talked to each other about the level of discussion with the nih is inspiring. The and election pursue, the science, it gives you a sense that the United States is on the cutting edge of these efforts. It gives us a sense of pride. More than that, it is what you doing to push the edge of the envelope in so many directions in terms of saving lives. We were both on the committee when we doubled the amount of money for nih along with mr. Porter, it was so genuinely bipartisan. If there is an area in which we should come together, and understand the value of what we have here, i think it would serve as well to think through what we should do for the future. Im going to address an issue that, as you know, it has been of interest to me for a while. I know, for my colleague, as well. That is the gender talents in Clinical Research. Gender balance in Clinical Research. We work to make sure that women were representatied and Clinical Research studies. I do have to tell you that men and women differ in their responses to treatment. Often times, using the bottles that rely exclusively on male animals can lead to extreme harm. Dr. Collins, in may of 2014, you coauthored an article in nature. You announce the nih would report their plan to balance now and female animals in studies. You noted that this new policy would be rolled out in phases beginning in october 2014. Dr. Clayton noted let me just give you the two or three questions that i have in this regard. If you can give us an update on nihs new policy to require that both sexes be represented and plead credible in preClinical Research, what kind of responses have you gotten from the research community, are you seeing an Immediate Impact in applications for funding . Will you consider requiring the analysis of data by sex, and other subgroup demographics, as part of grant progress reporting . What are you doing to encourage journal editors to require an analysis of adults by sex . How are you Holding Institute directors accountable on funding studies on conditions that predominantly impacts women . Can we expect all future nih funded research to include both sexes, unless there is a christmas a specific reason to not include the . A lot of questions, i know, dr. Collins. But, i think it is imperative, because you are moving, and it is important to get all of this as we move forward. I know, in the past, some things have not move forward. Now, i think is an opportunity for us to address the issue again. I appreciate the question and your leadership in bringing this to the attention of the public. Certainly, i can assure you of my strong personal commitment to addressing this issue, as was documented in the article that i wrote with dr. Clayton. The update is that we have now had extensive conversations with all the Institute Directors and the Scientific Community including my Advisory Committee to the directorate, about this issue. I think there is generally broad embrace further need of preclinical studies to include males and females, unless there is a compelling reason, and that needs to be explained, not just that in the and is not it is not convenient. Studies that once only included male mice need to be doubled in size. That would double cost. That is a negative response. The idea that you should include males and females is really compelling. The idea that you should analyze data differently is compelling. It is called power analysis, and it can be applied to the situation. The Institute Directors, i think, are in the process now a finalizing their approval of the way in which we will implement this for nih grantees. I can assure you, this will be something which is not left neglected. We will have definitive guidelines for all grantees who are doing these kinds of studies about what their expectations are for reviewers who review these studies, it will be made very clear that it is part of how you are to review a grant it comes to nih. Journal editors have been in conversation with us, and we have had great interaction with them in the area of reproducibility. This fits within it. If you have two studies and one is male, one is female, that is called interesting new research. The nih is fully committed to making these things happen. It is time. It is overtime. Thank you. Absolutely, thank you. I will go next to my good friend from idaho. Thank you. Dr. Collins, and all the other directors, thank you for being here today. The bipartisan nature of the subject and his committee is very obvious, as it has been in the past. That is good. I think it would be the delight of everyone on the committee to substantially increase the research, if we do not have an 18 trillion deficit or debt. Still, it is something we put priority on and try to do in a bipartisan manner. I would like to add fuel whole bunch of different questions, but i will come out and visit with you for a day, take a tour of some of the institutes, so we can get down and have some good discussions. This personalized medicine the years i cannot, the Precision Medicine is fascinating to me. I understand that the collective use of technologies, such as genomics, and protein medics or Something Like that, i understand that in your testimony, you will focus on cancer right now. Obviously, it is a lethal disease, and so forth. Are there any plans to look at broader, maybe not as lethal diseases or as series diseases and affects that is life medicine could have . Absolutely. Let me be a bit more clear that maybe i was. The Precision Medicine effort has two components. There is another component which is a longterm ambitious effort of this cohort of one million or more americans in which we could study almost all diseases. Knowing that you are a dentist we can include dental diseases. We have not had a sufficiently large study to be able to get answers. This should be the way to go there. Thats true for diabetes, Heart Disease, alzheimers, virtually every common condition. With one million people, you will have enough events so you can really dissect what are the biomarkers that why did this to happen, the environmental factors. That is fascinating stuff. It could really advance the treatment of diseases and cure of diseases. Im going to submit some questions for the record, but the one that i wanted to ask is in our conversations and the past, you have expressed your support for an cancap. I know from several advocacy groups that putting more into this could come at the expense of research. I dont know that is the case, but you do request and increase in that division. Can you update us on how that is going . It is now three years old. It was the first new center in nih and quite a long time and it was focused on identifying the bottlenecks of going from basic science discoveries to benefits that nih could address with our partners in the private actor. Iinitially, there were concerns that nih was becoming a drug company. That was never the plan. Instead, we identifying areas of Research Development that anything will company could not come up with. While developing a new drug, will it be safe in humans or not . We use animal studies. Small animals its not accurate, we probably lose drugs along the way. Wouldnt it be better to test toxicity in human cells and not put humans at restisk. Wouldnt it be easier to represent cells on a threedimensional biochip. We can begin to do those experiments without putting people at risk and get very Interesting Data on what drugs will likely be safe or not at a much lower cost. We are doing this with it the fda. Pharmaceutical companies are widely interested in this. If it works, it could greatly improve the likelihood of knowing something is safe before you get into the expensive clinical trial. I could keep going on. They are quite innovative, and probably would not have happened without nih stepping in. They are high risk, but also high reward. The clinical translational science centers, present in many other states, is a network of 62 academic a centers and awful lot of Clinical Research is done. Thank you all and thank you for the work you do. I look forward to going out and visiting you. As i said, and i will continue to say it, for good or bad, nih is the best kept secret in the sea. D. C. All of us know, our good friend from california is dealing with the difficult personal situation with the loss of her mother. It is wonderful to have you back with us today. The gentlelady is recognized. Thank you, mr. Chairman for your condolences and support. And your real expressions of sympathy during this difficult. My mother and im so happy to see everyone here today, and want to thank you for your work and as the efforts to save lives and ensure the quality of life for everyone. My mother was 90 years old. She died of copd, which is the thirdlargest i have spent many a night and day in Emergency Rooms and hospitals but because of you and the work of the nih she lived to be 90 years old. My sister has ms and again because of you, the work of this committee, my sister is 67 years old and leading a very healthy life as a result of nih and the research and treatment. I want to see your budget doubled so everybody can first of all be free of these diseases. I want to ask you a couple of questions with regards to copd research in terms of prevention and treatment, also with regard to ms and your Brain Initiative, how that will impact people with ms sickle cell, i have been working for many years, looking at the a wednesday test and the correlation between sickle cell traits and diabetes, to see how that are they fully aware . In terms of the research. In terms of your budget, i am pleased to see the increase. What types of new treatments do you envision with this increase of 52 million . And finally, as it relates to the National Institute on Minority Health and disparities, really pleased once again to see an increase of 14 million in funding and want to look at how you are focusing on are looking at social determinants of health care. We know many of the Health Disparities in minority communities directly relate to the social deterrence at how this is being framed and researched within it. Personally, i have to thank all of you. Thank you very much, mr. Chairman and members, for your support. Those are great questions. [laughter] as a result of my family. Abductor givens can Say Something first about copd . Copd is the third leading cause of death in this country one in which we have provided pinnacle trials which have provided a better course of life. We need to do more. The challenges we often diagnose and treat the disease during the latter stages on the damage has already been done to the l ung. This is an opportunity for Precision Medicine, where we can diagnose and develop interventions early to prevent the deterioration that occurs. We are excited about the opportunities that are going to come from genomic medicine. Were beginning to understand the pathways towards death from that disease. Maybe i will ask dr. F alci about a trial he did about ms . Thank you. As you are probably aware, a few weeks ago we published a very exciting study, one of the most important studies we have seen in ms in which 25 subjects were involved in a phase two open label study of stem cell transplantation in individuals who had rapidly aggressive progressive multiple sclerosis. You would expect them to continue to deteriorate. The study was a resounding success, 80 of the individuals survived without any progression for a. Of up to three years, for a period of up to three years. The historical control is so it compelling because when you get the patients, they almost invariably progress and these patients did not. We are going to move on to the next stage of the study. With all of the things that we have been doing with ms over the last several years, in my mind this is the most exciting. You asked about hiv. There are some aspects of hiv, throughout the world including this country. We are seeing several countries taking the Tipping Point where the number of new infections is less than the number of people going on there be to the point where we are starting to see a deflection in the curve. The thing that would nail it really down with regards to prevention and the treatment is prevention programs with which you are familiar with and you can decrease 96 transmissibility from infected to an uninfected person by impact treating them and. There have been several studies that came out in the quite meeting in seattle last week that showed that preexposure prophylactics has provided a substantial decrease in infection rates in certain areas. There is a pursuing of the followup of the very exciting, the modestly successful, trial from several years ago that i reported to this committee. It was 31 effective. Not enough for prime time but enough to give us insight into the next stage of what were going to pursue. We started a trial in africa and it looks like the response in africans is similar to those in the thais. There is a whole bunch of research at the nih as well as a number of centers throughout the world. And looking at the ability to induce neutralizing antibodies which are difficult to induce with natural infection but we are making headway with in being able to induce them with the right immunogens. Thank you. Dr. Collins, your colleagues might be brilliant at minor very crafty at loading up questions. But they are great questions. The chair is going to be as generous as he can with the clock. Im going to move to my good friend, the distinguished member from arkansas. I will try to be quick. I have two or three questions. I. T. Was one of the people who went on the tour and thank you. Im in all of the presentations being made here today, just i as i was the day we toured the nih. Im going to follow up on a question from earlier. When you said you need to make sure patients can access new medications and treatments, coming out of the nih to combat Prescription Drug abuse, i completely agree with that. But right now regulations for medication therapy for opioid addiction prevent this and only push to medications two medications. What is the nih doing to make sure that patients can access these medications . Thank you very much for your question. For us to succeed, we have to work in partnership with our sister agencies. We have mechanisms by which we actually bring together researchers and clinicians to ensure developments in this case in the area of medications for opioid addiction are implemented in the treatment setting. Having said that, they are always a problem, in terms of ensuring that patients have access to these medications. I have made this point before including the need to make sure the insurance iss will cover them. There was also medication developed through them eight with very good outcomes and as of now we know that not only has this medication been effective in treating Substance Abuse they are effective in preventing overdoses and are preventing hiv. They work. We need to implement them. Dr. Collins, you would expect im going to have a question about idea funding, because arkansas is one of the states the benefits. We have a lot of underserved population and i know a lot of our applications go wanting and we would like to improve that. We are pretty much a rural state. In your fy i16 budget, you asked for a 3 increase over fy 15. However the budget request for the idea program, i would like to know why the program that helps states like mine, the other 22 states that helped secure this funding are not prioritized. Katie walked me through that process . Appreciate your question. The things accomplished through this program in states like france are truly exciting and a great opportunity like arkansas are truly exciting and a great opportunity. Over a fiveyear period, it has grown more rapidly than the rest of nih. He did not change in its total dollars this year but over the five years, it has been doing well. Idea thank you very much, mr. Womack, for this question. The idea program is now housed in iges. We are proud to have it there. Whatever the budget, were going to do whatever we can to make sure those goals, increasing the geographic distribution and ensuring that all 50 states in the union have cuttingedge Biomedical Research going on are met. I have recently traveled to arkansas, little rock, and saw some of the amazing Research Going on there and in the southeast regions of idea including in your district, the university of arkansas, we have a center there focusing on determining the threedimensional structures of proteins from viruses and bacteria and using that information do try to develop drugs to treat a variety of different diseases. What i can do sure you is that we will continue to push the goals of this Program Forward as best we can. I know that i am out of time. Let me finish by saying this, as i said in my opening, i am grateful for the work that is ming done by this agency and gives me a great deal of pleasure to be is a seated with a panel of experts like we have before us. Mr. Chairman, i yield back. Next, we go to my dear friend from pennsylvania. Thank you, mr. Chairman, and let me thank the panel. Let me ask about the joint programming for neuro research. Europe has been dissipated and there is discussion about china. Can you tell the committee how you plan to engage with trials through it . I really appreciate your strong leadership in the area of neuroscience area and. Thanks very much. Thanks for all youre doing in this area. The joint program we talked about is in aan eu program and they reached at twist recently. We have been most involved with the dementia part. I suspect there will be joint initiatives that have not happened yet. Were looking forward to working closely with the other g7 partners around the dementia effort. I know that Prime Minister cameron initiated that. I would like to get a particular review. Are we, are we not going to join . Me ask the question right in your alley where i have you lets me ask a question right in your alley, while i have you. I understand that in this way this Research Fund is from your institute, has become as they call rise covered after additional schizophrenic episode. Could you tell us where we are right now and what the future holds . Inks for that question. The raise program is a program that is been going on originally bolstered i the funding from 20092 thousand 10. It was completed in terms of its feasibility only in december 2013. This committee soffit soon after soffit soon after to ask santa to smasa to implement the program in nearly all 50 states. There are Pilot Programs that were developed in collaboration between nih and samsa. We are watching it grow in 2015. What we would like to do now is build on that in a very specific way. We want to be able to create a learning Health Care System out of these kinds of programs that would be really not so Much Research to practice but now practice to research. Learning from the experience where the care is being delivered, how to improve outcomes for people who have a First Episode and how to prevent that First Episode. Were trying to move earlier in the cycle. s has a Great Potential of preventing some of the tragedies we have seen around the country and another committee will have interest in as we move forward. Let me go 30,000 feet in the air. I have you chaired the working group i established the language in the commerce justice bill. Here, i am a junior chair but the fact that i can be in the same room as tom cole, i am happy. [laughter] you chaired the working group and the Brain Initiative is a major in inspiration but there are a number of other things in terms of imaging and the pharmaceutical industry that dr. Collins, you launched a partnership, there are a lot of things germinating. If you can help us understand the budget requests, dr. Collins, interms of the brain project, that would be helpful. I will take that on. I should say at the beginning that every time i go anywhere, i find out that hunger smith for todd has in their i find out that the congressman has just been there. I suspect you will get an honorary hd in your science phd in neuroscience. I asked a group of experts to sit down and create this tenure plan ten year plan. It will go to roughly 50 million by 2019. Pretty much like the human genome project. 2015, we will be around 80 million, with the president s request to cheer of another 70 million, that will take us up. But the question that gets asked for us over and over again seeing how spectacular the opportunities are. Re, you have a great roadmap but you have any gas . We are hoping with the funds we have, we can have another 50 or so projects come out this year. Going forward, whether we will be able to build this in the way we originally envisioned will depend on your support. Thank you. There are tens of millions of americans depending on your support. The gentleman got extra time but it may not get him extra money. Next, we go to the deadline from tennessee. Thank you mr. Chairman and dr. Collins. You all fight the maladies that face so many millions of americans and your research and commitment to medicine and science is incredible. So i thank you very much. As you all know, i have been a very vocal outspoken advocate for the fight against cancer. I lost both parents to cancer, when my mother when i was very young. One of the particular said things about cancer is children with cancer. I question today, and i hope you can help me, a little boy came to see me. He was blind, he had a brain tumor, he and his dad came to see me and sat with me. I was not even his congressman. But i sat with him and spoke with him about his cancer. I hope we can help me with this. Pediatric lowgrade astrocytoma is a slow growing cancer that impacts over 20,000 children every year. There are over a thousand new cases diagnosed every year. Existing treatments for p lga brain cancer are invasive highly toxic, and so far relatively ineffective. The treatments themselves can cause serious permanent damage and are often lifethreatening. But research is being currently conducted by the nih on plg a . What alternatives are on the horizon . Are there any Clinical Trials currently being conducted by nih for plg a . I would really like to respond back to this little boy. Thank you for your question. The director of nci is out of the country but i will try to answer. It is one of the cancers where we need better answers for. It doesnt respond particularly well to the kinds of cancers growing rapidly. Clearly, theres a connection between what we were discussing a little bit ago in terms of the cancer focus of the Precision Medicine initiative. As part of that, the Cancer Institute aims to and roll Something Like 1000 pediatric patients in this earlier stage of trying to understand what drives malignancy. I would be here surprised if some of those were not in fact yet p dla patients. One of the problems is access to tissue. It is not easy to do a biopsy of a tumor growing in such a vulnerable lace. But there are potential ways of looking at that by looking at dna floating around freely in the blood. Cancers release their dna and one can discover it by looking into the circulation for free dna that is not inside a cell that might tell you what is going on without having to do a needle biopsy, a liquid biopsy. That would be one area of focus. And terms of Clinical Trials, i cannot know at the top of my head what is there. I would go to Clinical Trials. Gov to see what is listed. It is a terribly difficult condition and we share your concern about needing that her answers for that boy who came to see you. Ill ask a followup question on something else. Our country prides itself on being at the forefront of research and Biomedical Research is no exception. You expressed concern about the amount of money going to international research. Why, with a budget the size of nihs, you have these concerns . What do are you doing to take it manage of the research being done in other countries . A great question. Many major programs, including the human genome project i had though privilege of leading, were international. Six countries were involved in that and the data was made immediately accessible. The country that leads and Biomedical Research enjoys other benefits, especially with commercial spinoff. We are not only great and academic Biomedical Research, we also have the most vibrant community of Small Businesses Biotech Companies and pharmaceutical companies. We would not want to lose that benefit and yes when you look at the trajectory that are funding is on, compared to other countries, there are deep concerns. We lost about 22 of our purchasing power for Biomedical Research since 2003, a very significant downfall. Other countries are going the other way, china and particular in particular increasing by 20 . I would refer you to an article that has a lot of data and it pointing out a number of things that are alarming if you care about the u. S. Maintaining that leadership. China is now filing more patents than the u. S. The consequences come i think you can imagine, are going to be significant. Final conclusion of this article , and i think this is a distinguished group that wrote this is that Given International trends, the u. S. Will relinquish its Historical International lead in Biomedical Research in the next decade unless certain measures are taken. They see the pathway and do not like what is happening. We can turn this around her it what nih needs especially for the earlystage investigators is a sense of stable trajectory, that we have a chance to be able to plan, take risks, do innovative research, without the uncertainty about what will happen one year or the next. Maybe a doubling will actually be a nice thing but what would even be better it would be an opportunity to see a path forward that keeps up with inflation, plus a little bit and that we can count on and people could basically then flex their innovative muscles and take advantage of this amazing town that we have in this country. Thank you. Ill back. Yeild back. Let me associate myself with the comments that were made by my colleagues about tremendous work that you all do and what a positive impact it has had on the quality of life of so many people, not just in this country but throughout the world. But i do have some concerns that i would like to address. Dr. Collins, in 2000, is congress authorized the National Children study to investigate how the environment influences a childs development and health and over the last 15 years, congress has appropriated over 1. 5 ilion dollars billion dollars to pilot the study. Congress expected this study would be carried through to its completion but in fact in every fiscal appropriations report from the year 200020 14, there have been specific instructions from of the house and senate directing the continuation of the study. In march of 2013, congress requested a review of the revised study defined by designed by the institute of medicine and they concluded there are conceptual methodological administrative challenges that must be addressed. But the ncs still offered, and these are there words, indoor miss potential. They also concluded that when the study was completed, it was quote, add immeasurably to a we know about Childrens Health in the United States. After reading the summary report and given the billion and a half dollars that has been spent, i was frankly very surprised by your announcement canceling the National Childrens study. Im sure im not alone in believing that a better outcome for the 1. 5 billion should be at least completed study. My question is, by what authority did you use to disband the study . Congress has been one with 5 billion i spent 1. 5 billion. Congress has spent 1. 5 dollars. I would like an expiration explanation. This is been one of the more difficult decisions. The study was designed in various pieces over quite a long period of time. As that time passed, some of the design issues in retrospect maybe were not serving the need of getting the information which we all agreed was crucial to understand Environmental Impact factors that occur during pregnancy and beyond that influence child health. We all agreed those answers need to be found. The problem that increasingly seems clear was that the design which carried with it a certain historical legacy was not sitting with the way in which technology was developing over the course of the last almost 20 years. The iom said he you mentioned was in fact quite critical about those issues, about administrative issues, and because of that i asked a working group of my Advisory Committee to look mostly at all of vast of the children study and make a recommendation to me about whether it was still feasible. They came back instead frankly, they did not believe it was. It was more important to make sure the data elected by the vanguard studies were made available and kept in place for those who could learn from it. But that we really ought to think about coming up with the new strategy to get answers to these same questions. The congress, in the omnibus bill, give us the opportunity to take the hundred 65 million in fy 15 budget and think of new ways to obtain new answers about these questions of environment and pediatric health. We have and vigorously engaged in that effort over the course of the next month and we will in the very near each future announce the programs, which i believe you will find are quite innovative. The Silver Lining is that it gives us a chance to step back from the last 15 years and say that in 2015, with all the technology that has that vance, what could we do that would get better answers, perhaps for less cost than originally contemplated for a 20 year study. We are quite excited about it. The institutes have all gotten very engaged in this opportunity to rethink this. Ultimately, i think we will get to where we need to be but in a different way imagined in 2000. As my understanding according to a Bloomberg Business report, a researcher at the university of california irving who ran a highlight and was one of the lead investigators of the study said that the iom report, and i quote, they did not conclude enterprise was beyond saving and it was a decision by nih and we know that a study like this is feasible and identify the pathway. That was a decision made by nih not based on the outcome of the iom report. Just very quickly, i know my time is up, what is the time and funding that would be needed for nih to address the recommendations made in june. I would ask the gentleman to be brief. Very quickly, in terms of the process, and if you read chapter five and chapter six of the iom report, not always well reflected in the executive summary, it is actually very critical of some aspects of the study. My Advisory Group came to a very strong and unanimous conclusion that the children study was no longer feasible. I had to accept their conclusions because they were so wellfounded, in terms of where we go, please look at the next proposals coming forward very shortly about how we will address his issues. We do have a lot of things to talk about going forward. We need to have that conversation. Thank you. I want to go to the one member on our Team Appeared that might actually have the intellectual firepower to stay with your team. I recognize dr. Harris. Thank you very much. Inc. You all for coming and appearing. I will start with a rhetorical question. You probably know ive wife passed away from Heart Disease three days before her 50th birthday 58th birthday. We have underfunded Heart Disease research in women over the years. I looked at the chart of what nih spends on. The amount we spend per death is 100 times less on Heart Disease then hivaids. 100 times less per death. That kind of discrepancy just needs to be justified. This is going to be a rhetorical question. It is stunning what the discrepancy is and how the fact that we dedicate as little as we do to Heart Disease, the most prevalent disease in the country. How that will affect the population. Tour question on that one. Rhetorical question on that one. Im going to ask you a question about drug use. Some people might not think that marijuana is dangerous or addictive but it is dangerous and addictive. It affects a lot of things that are probably not good for people, especially our youth. Do you know what that Economic Impacts of marijuana use . On education . \ do we had his answers and are they important things to study . Before we go willynilly into legalizing a dangerous and the drug . There have been many studies that highlight the consequences of use of marijuana among teenagers. They have consistently shown that it actually decreases the likelihood that you will finish school and get a degree. With the respect about the impact in the workforce the data there is much less clear. Studies have not been done as extensively as for education. We know in general that the use of drugs in the workforce is responsible for 30 less productivity on an individual that takes drugs but that has not been distinguished with respect to marijuana or cocaine or meth. We do not have a precise number. Just a quick followup, you would imagine that since marijuana actually affects motivation, something that might be important when you go to work, you might imagine it might have quite the influence on the workforce. What it is shown at the contradictions when you are present, you are there but not really working. The lack of motivation might cause that outcome. We should expect scientific answers, i imagine. I completely agree. Dr. Collins, let a followup again about some things that are being said about internationally. 50,000 foot view. I think that you sent something around, your article in january of this year, suggesting that china will overcome the United States in 2022 which i guess if you look sadistically and its impact potential growth continuing and rings like that but what is interesting is that the growth in time and is actually in the private investments. The industry investments. The real growth is in the private industry. One worse than trend in the United States is that the industry investments has gone down. That is not your where you have the ability to directly impact. That is there are certain policies that under the that that affect that. It doesnt help the Biomedical Industry when we negotiate a trade treaty that will hurt our Biomedical Industry. What is the strategy . One interesting thing is that the administration is spending 35 billion additional dollars that we do not have on nondiscretionary spending but only at the percent increase to the nih. That is a drop in the bucket if we dont get a larger picture of the entire Biomedical Research effort in the United States. What can we do and what can you do at the nih to implement a strategy where we can promote industry investments . We are leveraging nih dollars as it appears china is doing. To be fair, do not stand that up right at the end of the time and leave them hanging. Very quickly, i agree we have responsibility and an opportunity to bring together the public and private sector investments in Biomedical Research like never before. One example of the accelerated Medicine Partnership i spent three years working with a number of research and development in a number of pharmaceutical companies particularly pfizer. Excesses paid 5050 by the public and private sectors doing things never attempted before for alzheimers, diabetes, lupus, putting scientists to run the same table and holding themselves accountable for milestones and making the data available. It is unprecedented. Were one year into it and ahead of schedule. Im looking for the opportunities i can find where the traditional firewalls they got in the way of progress for not making sense. We need to think about creating endeavors about creative endeavors. Thank you very much. Im going to go to my patient friend from virginia who is here early and has waited a long time. Thank you chairman. I appreciate dr. Collins and your colleagues for being it today and im learning a tremendous amount. I want to bring this is not a question, because i will get to the question, that i took note of your comment about how helpful is would be to have confidence in continuity of funding. I have transitioned from Health Services to this committee and i was to wear our senior struck about how they would say the same thing about how beneficial it would be to be on regular order. Im going to continue to fight for that. I know my colleagues will as well. I just dont have what you said and i want you to know that. I have an incredible district, highest concentration of men and women in the country in uniform. I want to talk for a moment about the ptsd. I know that there is some funding for it, included in your budget. 79 billion and i believe it is to go to 81 million excuse me, million. I better get that right. My point is this. Help me to understand, by the way from the president down to the first lady, this is a shared american value. I do not question for a moment anyones commitment to this. That said, i did not see it mentioned in your budget justification and i know that the department and theres the a are working on this as well but help us to understand what is false and the priority level. And i know that the department of defense and the v. A. Are working on this as well but help us to understand what the priority is. Very quickly. Our institute was founded in 1946 and charged in 1949 to deal with problems for veterans. We tried to figure out what causes ptsd and how to treat and prevent it. We havent working very closely with the dod. It is area where the relationships of industry, we are taking on in a very joint way, especially the department of the army. He has worked on the Stars Initiative hundred thousand soldiers, trying to understand what causes ptsd and depression and high Risk Behavior and suicide, which is the worst outcome. Having worked as closely with the ideas we have over the last three or four years that is been a great inspiration. That study has completed its first date and is moving into its second stage. Already, were getting insights into causes and prevention. The question of allocation, generally, how much is allocated to one disease or particular challenge that we face, dr. Cards can you help me understand , especially when things need to be reallocated. Like most american families, we have had lost due to alzheimers and cancer and things like this. How is all of that structured. I would like to see a higher allocation for the topic just mentioned. How is that process unfolding . That is a question that many people ask and they should. It is an ongoing organic process of looking at what is the Public Health need and where are the scientific opportunities. What is the current portfolio look like and we have gaps we need to fill . We are constantly doing that kind of analysis. He more tools than we used to, a whole series of ways to look at our portfolio and figure out whether we have to balance on a plaque in terms of where our dollars are going and where the Public Health need is. Sometimes there are Rare Diseases we can learn a lot from about, diseases or which only affect a few people which desperately need it. If we did everything based on Public Health need, we would neglect Rare Diseases. Alzheimers comes to mind with a burden on individuals and their families and the cost to society is so daunting that we feel we have to push even harder, as long as the scientific opportunities are there. It is a constant recalculation. All of this would be easier if you are not in a circumstance where frankly we are underfunding virtually everything we are doing, versus what we could do with the talent out there. Thank you for your comments and i yield back. For informational purposes, as my colleagues and witnesses know, we do have time constraints this morning. Im going to go to mr. Dense and then close out as a committee. Thank you all. Thank you for receiving us a few weeks ago at the nih. Dr. Collins, i just want to mention, analysis of the National Cancer institute eta from 1970 52 2005 found that liver cancer instant rates increased by more than 300 from 1. 6. The cancer has seen the second largest annual increase of any cancer in the u. S. Other than thyroid cancer. Historically, the survival rates have been pretty dismal. The survival rates between two dozen three and 2009 has only been about 16 . It is secondworst among all cancers, only slightly better than pancreatic cancer. But andt can you tell me why . I appreciate the question. Liver cancer is a condition that many components of ncr involved in working on, whether there is a specific division focused on it, there is aattention. It is particularly likely to occur in people with hepatitis c. I would have to take for the record you opportunity to respond about the organizational part of nci. I can know that silly when on where the work is going on i can no doubt so you in on fill you in on where the work is going on. I met with dr. Frieden and we discussed the recent breakout of antibiotic resistant bacteria, also referred to as superbugs. It is so serious that president obama issued an executive order declaring that combating superbugs with the National Security priority. They are highly contagious, untreatable infections that spread in a hospital setting particularly. We are very intensively involved in collaboration with the cdc. As you note the president s Strategic Plan and the executive order and the program is a multiasianagency our fundamental mission and that multi agency approach is fundamental basic research and understand the pathogenesis, particularly with the new sequencing capabilities we have to examine a wide array of quasispecies that are resistant. It has put us in a situation where we can do things that were not imaginable years ago. Number two, we started if you use ago and have now amplified its with the president s request for antimicrobial resistant research. It is part of our Broad Network of Clinical Trials to be able to do some studies that you cant do in a given individual institute because of the fact that the incidence of outbreak with one or two cases is very difficult to get good clinical data. We are now collaborating with the cdc, they are doing mainly civilians and we are doing fundamentally the research. Finally, we are doing work on developing vaccines for some of these very difficult microorganisms that are highly susceptible when you think in terms of people, for example, who have transplants or who are in you suppressed. Not only mersa. So you have an a request for an additional 100 million. In the president s 2016 budget 116 million for antimicrobial resistant research. Thank you and ill submit my questions for the recorder. Now to the gentlelady from connecticut. Let me follow up on my colleague, mr. Dents, questions on antibiotic resistant bacteria. There is a significant increase in the budget. Can you talk about the new technique discovered to deal with this and also there is some misunderstanding of how long its going to take to be able to use that. Can you give us an idea about how long a timeline for the potential availability of, and i and i dont know if im pronouncing it right, but tecksabat. Recently i was in haiti and i met a doctor who talked about the antibiotic resistant tuberculosis. Are there drugs in the pipeline to treat drug resistant t. B. . And again, finally, i understand youre dealing with looking at a database. For this effort. Antibiotic resistant infections. But there are many of them to put it simply, in my simple language on this but if the database is going to hold all genome sequence data for the 10 deadliest antibiotic resistant pathogens, what kind of effort would that entail . Ok, three questions. I wanted you to get about whats talking happening in liberia. Well do that. So the n. I. H. Is very pleased with this because this was an entirely funded n. I. H. Effort to the tune of 20 million and we now have a new class of antibiotics that have developed from the soil and the issue is weve got to be careful, its not going to be tomorrow or next month where thats going to be available on the market because we need to continue to do preclinical studies in the animal model before we can get into the human situation. Id like to say its going to be around the corner but it likely will be over a year before we do that. The good news is its a brand new concept of an antibiotic that essentially skirts the resistant mechanisms that other types of microbes use against the common antibiotics. It will likely be good against microbes for which there are multiple resistant. T. B. , good news here also. We partnered with Drug Companies with several of them, particularly jensen, develop new and jensen, to develop new drugs that are good against some of the multiple and extensively drug resistant tuberculosis. So we do have one, maybe two in the pipeline. If you asked me last year i would have said, we dont have anything new. Database, and this is something we do well. We have phenomenal sequencing capabilities now. Thats one of the things we put as a high priority, to be able to use our technologies to get databases of essentially all of the various versions and iterations of antimicrobial resistant microbes and be able to share them and as we do at , n. I. H. , its open access. It is open to the general public. Liberia . Ebola . Zmapp trials . Vaccine trial started february 22 in liberia, in monrovia. My deputy is there now overseeing the trials. We started off with a phase two for 600 individuals where well access slowly to make sure its still safe and immunogenic. And then well go to the full total of 29,000 people. It was the vaccine you mentioned was developed by Nancy Sullivan in the Vaccine Research center together with the v. S. D. V. Vaccine which we collaborated with the department of defense getting back to the other question, about our collaboration with the department of defense. Those two are ongoing. Its up and rolling. Zmapp was very, very favorable in animals. We dont know if it works in humans. We started a comprehensive protocol that was announced three days ago by the ministry of health in liberia, actually at the same time the president of liberia was meeting with our president here, right here in the United States. It started a few days ago and what its going to do is compare standard of care, namely intravenous replenishment of fluid, against standard of care , plus zmapp. The zmapp is a cocktail of three separate antibodies directed against the ebola virus. It looked very good in animals but we need to prove definitively if it will work. Both of those are n. I. H. Driven trials and both are ongoing in liberia right now. Thank you. Just, first of all, dr. Collins thank you very much, and your colleagues, for being here this morning. I have no doubt this is not only the most Brilliant Panel well see all session, its the most Popular Panel well see all session long. Thank you very much. We need to have a group hug. [laughter] [indistinct noises] this weekend marks the visit anniversary of the march in selma. Speakers included john lewis president obama. We will bring you those remarks running at 5 p. M. Eastern