United states. A quick followup on africa. Ways and means has pointed out that there could be a problem between the u. S. And africa u. S. And the event e. U. If the u. S. Begins to get preferences in the african market. You chose a different path. Two quick questions. One, will you have some flexibility so you dont harm u. S. Exports and, two, have you given any thought to a common origin rule perhaps being part of epa where excuse me being part of ttip where the u. S. Recking nices african inputs the recognizes african inputs the same as export to the u. S. And vice versa so this wouldnt promote african participation in the Global Supply chain. And the third very quick is on g. I. S some are concerned youre use r using the lisbon agreement to make some progress. Perhaps that should be better left for the negotiation of the ttip in terms of this very controversial issue of geographical indications. Thank you very much. Thank you. That was a lot of questions. On tpa we are, of course, following that process very closely, and i know its an intense debate here. We have looked at what has been proposed, different amendments, but thats one of the reasons i wanted to be here in may as well to discuss with the team to get his sense of this and what will actually become the end vote. So its very difficult for us to have a position on individual paragraphs or amendments in tpa. We need to get clarity what it means in practice. For instance, the ones you mentioned on africa. What we have been doing in africa for a long time, i think is a good thing opening up our market for them and giving them access. That is to support their economy and their growth, and we dont think that is being done, you know sort of to harm u. S. Interests, its to promote our interests and theirs, but ill be happy to discuss in this morning with mike froman as well. And we hope that the tpa and tpp can be concluded quite soon because, as i said earlier, even if tpp ttip has a parallel negotiation track, of course it cannot be concluded before congress and the senate has agreed on the tpa. So thats why its very important for us as well. On the wipo, this is a e. U. Is not a member of wipo. There are nine e. U. Countries who are members. There is a congress coming up. We are, of course, following that very closely. The u. S. Is not part of it, so whats happening there is for the members to discuss. And our discussions on geographical indications needs to have a parallel track. We need to find a solution, a way forward that everybodys happy with. As i said, this is a difficult issue, but we are willing to look at this and im sure it can be done. It has been done with others. Fantastic. Okay. We have a question right here in the front. Good morning. Im greg with the American Cancer Society cancer action network. The e. U. Has a rather robust Tobacco Products directive and we are seeing trade disputes around world involving government regulation of tobacco to protect people from disease and death. Can you say a little bit about how protection of Public Health particularly on issues like tobacco are factoring into your consideration of positions on isds . Thank you for that question. I think that is an illustration of why isds has become conflictual as well, because people in europe have seen Tobacco Companies suing governments because of their willingness to protect the citizens from damages of smoking with plain packages and so on. And thats why we put already in the canadian agreement a provision that states have the right to regulate to protect the health or the safety of the citizens. And this cannot be put into question by a company. And we are strengthening that language in the proposed reform of the system as well. So the case that is ongoing right now would probably not be successful or would not be successful with the new terms that we have put up with isds. States have the right to regulate to protect their citizens in tobacco and in other areas. Fantastic. Question over there please. Microphone is coming your way. Hi, commissioner. Business newspaper. Really glad to see you here because i was based in brussels last two years i follow you. [laughter] yes i follow ttip from the u. S. european joint announcement. My question is in Washington White House and congress use china as a subject to get through all the blocks like tpa and tpp saying if u. S. Doesnt set the High Standards china will. I want to ask you commissioner also use china as [inaudible] european difficulties from Member States of parliament, and do you think ttip is really about setting a High Standard between transatlantic and exclude other nations other emerging countries . Thank you. Well, its not for me to comment on what politicians here in the u. S. Have said about one thing or another. We think that ttip is a great possibility to create the largest free trade area between the two biggest economies of the world for the moment, europe and the u. S. And we are convinced that setting standards there is a good thing. If we can set standards in a new generation of standards in different technologies, we have good people who put standards in regulators in europe, we have in the u. S. As well. If we can set some standards they have a good possibility to become global standards. But we are doing this for us and for our people because we are convinced it would be good for how economy. But were not doing it, you know position to anybody else. Of course, as i said in my introductory remarks theres a spaghetti bowl of different Bilateral Agreements and, of course, they can be seen as all hostile towards each other, but thats the world we live in. Everybodys making agreements. Chinas making a lot of agreements as well. We are engaged in a trade Investment Agreement with china from the european point of view, and we hope we can finish that quite soon and we also cooperate in other foras. So it is not directed toward someone else, but its a good thing to do in itself. Fantastic. Why dont we take one more question. Sir, youll have the last question. Thank you maam. Sam gillston with washington tariff and trade letter. One of the key elements of the talks is in regulatory convergence. You didnt get into that very much. Can you give us an idea of the status of how well those are going, what are the big problems, and which areas do you see most likely to have something in this agreement actually come out . Yes. This is an area where we have made good technical progress but, of course, it takes time. We have identified, like, eight, nine different sectors where we think there is scope to recognize each others standards, in the car sector cosmetic engineering, medical devices, what else . Well, theres a variety of sectors where we think that we could recognize each others standards because, for instance, we do inspection of factories. They have to be done where you do pharmaceuticals. We do it in one way in the European Union you do it in a very similar way in the u. S. And theyre both as safe and as good, and they produce the same results. But for a company that wants to export to one side or the another, you have to do it twice. That costs a lot of money. Medical devices have to go through a formal operation system twice. Car crash tests. If i want to sell a dress, i have to put it in [inaudible] in europe our way and i have had it in the i have to do et in the american way as well. So very, very similar to protect the goals of consumers but we have to do it twice and that costs a lot of money. So we can recognize each other standards in these sectors i think that could be a very good thing especially for Small Companies who dont have the room to maneuver to pay for these extra fees. And if we can do it for future regulations because we have very good regulators on both sides to set future standards in electronic [inaudible] or nanotechnology or whatever, we could, we could perform one global standard that would have an effect for the rest of the world. And then that could, of course, be a very good thing for business and it could also facilitate for the rest of the world who want to export [inaudible] one standard instead of two. So this we have made good technical progress, but its not done yet. So we have to go through sector by sector case by case, and to to convince each other that our standard is as good as yours but we are making progress here. Our Technical Team is even between the different negotiation rounds, so i hope we can announce some result there later this fall. Well, commissioner malmstrom thank you so much. You addressed a very broad range of issues with good humor great common sense. I have a feeling were going to be seeing quite a bit of you in washington and i think ambassador fro matchs going to get some fromans going to get some frequent flyer miles over the next several months. [laughter] we hope the next time youre in washington youll return and help us understand the process. This is extremely helpful, and i for one would like to sit through your isds 101 class that you gave. Maybe that should be something you do the next time. Were grateful that you spent your time with us. We wish you the best with your meetings with the commerce secretary, ambassador fro match and others. With your applause, please join me in thanking commissioner malmstrom. Thank you so much. [applause] [inaudible conversations] a quick reminder on this monday morning that if you missed any of this program that we just showed you, you can watch it anytime in the cspan video library. Go to cspan. Org. And live coverage still to come here on cspan2. At noon the Cato Institute will host a forum looking at the future of south africa. Panelists will also talk about the political and Economic Development in the country since it transitioned from apartheid to majority rule government system. Thats live at noon eastern right here on cspan2. The u. S. Senate will return at 3 p. M. Eastern today and theyll consider overriding a president ial veto of a measure dealing with regulations on Union Election rules. Senators also expected this week to continue work on the iran Nuclear Oversight bill and start consideration of the 2016 budget resolution that was negotiated by house and senate conferees. The house, by the way is out all this week for a district work period. Members will be back for legislative business on may 12th. As always, you can see live coverage of the house over on cspan and the senate live right here on cspan2. In Campaign News today ben car soften is announcing this morning carson is announcing this morning that he is going to run for president in 2016. Dr. Carson, whos a retired neurosurgeon, is set to make that announcement in about 15 minutes from now in detroit, 10 30 eastern today. Politico has a story about it. Dr. Carson began to draw interest from the Republican Party after speaking at the National Prayer breakfast in 2013 where he assailed president obama over the Affordable Care act while the president sat in attendance. You can watch ben carsons candidacy announcement on cspan this morning starting at 10 30 eastern followed by your phone calls and comments. And politico also writes about carly fiorina. She announced today she will also seek the republican nomination for 2016. Quote yes i am running for president , she said on abcs Good Morning America today. She also launched her campaign web seat today with this web site today with this oneminute video. Im getting ready to do something too, im running for president. Our founders never intended us to have a professional Political Class. They believed that citizens and leaders needed to step forward. We know the only way to reimagine our government is to reimagine who is leading it. Im carrie my carly fiorina, and im running for president. If youre tired of the sound bites, the vitriol the pettiness, the egos the corruption, if you believe that its time to declare the end of identity politics, if you believe that its time to declare the end of lowered expectations, if you believe that its time for citizens to stand up to the Political Class and say enough, then join us. Its time for us to empower our citizens, to give them a voice in our government, to come together to fix what has been broken about our politics and our government for too long. Because we can do this. Together. President ial candidates often release books to introduce themselves to voters. Heres a look at some recent books written by declared and potential candidates for president. Former secretary of state Hillary Clinton looks back on her time serving in the Obama Administration in hard choices. In american dreams, florida senator marco rubio outlines his plan to restore economic opportunity. Former Arkansas Governor Mike Huckabee gives his take on politics and culture in god, guns, grits and gravy. And in blue collar conservatives, potential president ial candidate Rick Santorum argues the Republican Party must focus on the working class in order to retake the white house. In a fighting chance, massachusetts senator Elizabeth Warren recounts the events in her life that shaped her career as an educator and politician. Wisconsin Governor Scott walker argues republicans must offer Bold Solutions to fix the country and have the courage to implement them in unintimidated. And kentucky senator rand paul who recently declared his candidacy, calls for Smaller Government and more bipartisanship in taking a stand. More potential president ial candidates with recent books include former governor jeb bush in immigration wars, he argues for new immigration policies. In stand for something, Ohio Governor john kasich calls for a return to traditional american values. Former virginia senator james webb looks back on his time serving in the military and in the senate in i heard my country calling. Independent vermont senator Bernie Sanders recently announced his intention to seek the democratic nomination for president. His book the speech, is a printing of his eighthourlong filibuster against tax cuts. And in promises to keep, Vice President joe biden looks back on his career in politics and explains his guiding principles. Neurosurgeon ben carson calls for greater individual responsibility to preserve americas future in one nation. T in fed up, former Texas Governor rick perry explains government has become too intrusive and must get out of the way. Another politician who has expressed interest in running for president is former rhode island governor lincoln chafee. In against the tide, he recounts his time serving as a republican in the senate. Carly fiorina former ceo of hewlettpackard, shares lessons shes learned from her difficulties and triumphs in rising to the challenge. Louisiana governor bobby jindal criticizes the Obama Administration and explains why conservative solutions are needed in washington in leadership and crisis. And finally, in a time for truth, another declared president ial candidate texas senator ted cruz recounts his journey from a cuban immigrants son to the u. S. Senate. Look for his book in june. A Senate Appropriations subcommittee held a hearing last week on the 2016 funding requests for the National Institutes of health. The groups director, dr. Francis collins was joined by a few of the 27 directors of the institutes and centers to talk about some of their initiatives in Precision Medicine and the progress being made in their respective areas of Biomedical Research. This hearing is led by subcommittee chair senator roy blunt. The appropriations southbound committee on labor health and Human Services and education and related agencies will come to order. Certainly, were pleased this morning to see dr. Francis collins and the Institute Directors from nih with us. Glad to have you here to talk about the budget. We look forward to the the testimony and the opportunity to talk with each perp on the panel person on panel about these issues as they come up. Throughout history the practice of medicines been largelya xd reactive. Even today we have to wait until the ons of most diseases before were able to treat them or begin the process of curing them. Science doesnt fully understand the genetic and environmental factors that cause major diseases such as cancer, diabetes alzheimers disease. Because of that, treatments are often inprecise often unpredictable and unfortunately, up not effective. This budget that you all have proposed really proposes a revolutionary concept of addressing each individual in a precise and off different way often different way. The Precision Medicine initiative would allow physicians to really individualize the treatments on patients based on their unique genetic makeup. By having access to each individuals genetic makeup now a physician has the potential we hope, to decide not to use or to use specific and targeted drugs. As the chairman of the subcommittee i certainly will support this project. I hope we can prioritize and intend to prioritize funding for nih as one of the things the committee does even in a year where our funding challenges are greater than they sometimes are. We always have funding challenges at home at work, in the government, have those funding challenges. But part of that challenge is to decide how to prioritize how we spend our money and certainly im anticipating that this committee will be as supportive as we possibly can of not only the Precision Medicine initiative but also of the ongoing work of nih and the promise it holds for the future. I look forward to working with you, dr. Collins with the Ranking Member and the members of this committee as we pursue the ideas that youre going to bring to the table today and the potential of what can be done in nih largely and specifically at each of the institutes that are well represented here today. Were lucky to have the chairman of the full committee with us, the Ranking Member of the full committee will be here as well, and its a great honor opportunity for me to get to work with senator murray. Senator murray, if you have an Opening Statement well have that before we go to dr. Collins. All right. Thank you very much, chairman blunt. Dr. Collins, thank you to you and your team for being here. I look forward to this really important discussion today. All of us today can agree theres a lot more we need to do to keep families and communities healthy and continue investing in priorities that strengthen our economy from the muddle out. Of course, the work of the National Institutes of health is vitally important to this effort. The nih supports basic research that makes medical advances possible. It gives hope to those who are living with chronic and lifethreatening disease and helps drive Economic Growth and competitiveness. We have all been touched in one way or another by the research nih hasported from supported from its pioneering use of gene therapy to treat cancer to development of antiviral they weres to treat hiv or efforts to reduce the incidence of diabetes and preterm birth. Biomedical research is an important investment to insure our Government Works for all of our families. The investments we make in nih as well as in education and other programs in this bill thats supported indirectly to help insure that americas work force in the years ahead will be able to create and take on the jobs of the 21st century. Thats why like chairman blunt referenced, i am deeply troubled by the steady erosion of nihs purchasing power over the last decade. And im equally concerned about the similar erosion that has occurred in many other categories of the budget that are essential to promoting a strong and growing middle class. Whether its funding for rebuilding our roads and bridges or for pell grants or childcare block grant making sure that we are investing responsibly in our National Priorities Like Research and infrastructure and education remains one of my highest priorities. Of course, last month the Senate Debated and passed a budget resolution and unfortunately that Budget Proposal and the one that was passed by the house falls short of the funding levels that we do need to insure stable and increasing support for nih and orr priorities. Im very proud as youll remember back in 2013 democrats and republicans were able to reach a budget agreement to roll back sequestration for fiscal years 2014 and 2015. Rather than going back to the days of up certainty and short uncertainty and shortsighted, counterproductive consistents, weve got cuts, weve got to replace those automatic spending cuts for 2016 and beyond. The president s budget would do just that by fully replacing sequestration of defense and nondefense discretionary spending. That approach makes it possible to provide a billion dollar increase in funding to support nih efforts aimed at increasing our understanding of the human brain and addressing the growing threat of antibioticresistant bacteria or advancing work on developing a universal flu vaccine or finding treatments and cures for diseases that cause suffering and cut lives short. Their budget also supports a Bold New Initiative to exploit the recent advances in genomics, molecular biology and Data Management to support the shift from onesizefitsall medicine to one tailored to specific individuals. Precision medicine holds great promise for further advancing the treatment of cancer and ultimately, the full spectrum of disease. Im very proud that my home state of washington is home to several institutions that have really been pioneers in the field, and that includes Fred Hutchison Cancer Research center, the university of washington which are using Precision Medicine Technology Today to tackle breast cancer, eye disease and alzheimers disease. Dr. Collins, the clip you can researchers i et clinic researchers i met with believe these approaches are going to transform the field of medicine, and i know thats something you agree with. While there is much opportunity however, funding constraints have made it harder than ever for new researchers to land their first grant. The private sector funds very little basic Biomedical Research leaving researchers feint on a stretched pool of funding of nih funding. Im very pleased to see, dr. Collins, that your budget is sensitive to the problem and focuses on leveraging nihs resources to identify and support innovative and exceptional junior scientists. This is just one of the challenges the nih faces in what many feel is a remarkable time for medical research. So i really am hopeful that democrats and republicans can come together against this time again this time and build on the bipartisan foundation that was set in last congress so that we can make the investments we need to seize on these opportunities that are so important for our families and our economy. Thank you very much, mr. Chair. Thanks, senator murray. Dr. Collins, were eager to hear from you. Well, good morning chairman blunt, Ranking Member murray chairman cochran members of the subcommittee. Its an honor to appear before this panel given its long history of supporting nihs mission, to seek fundamental knowledge and apply it in ways that enhance human health, lengthen life and reduce illness and disability. As a federal research agency, we are acutely aware that to achieve our mission we must serve as effective and efficient stewards of the resources provided by the American People. One way were doing this is by focusing on prioritization of nih resources. This involves developing advanced methods of portfolio analysis identifying compelling scientific opportunities fostering Creative Trends in nih collaborations and enhancing the use of the common fund. Were also forcing interagency partnerships like the nih darpa project to develop biochips as well as innovative Public Private efforts like the accelerating Medicines Partnership that is seeking to identify new drug targets for alzheimers disease type ii diabetes and autoimmune disorders. To help set priorities, we are developing an overarching nih Strategic Plan to be linked with individual institute and center plans, and this will set the stage for the future of Biomedical Research. Were also working to enhance the drs. Ty, the fairness, the rigor and the reproduce about of nihsupported science. And finally we remain firmly committed to strengthening and sustaining the biomedical work force by incentivizing early stage young investigators and revitalizing physician scientist training. With these goals in mind, were confident we will be able to support the best science while advancing our core mission and inspiring public trust. We take this stewardship responsibility with great seriousness. And let me assure you the future of Biomedical Research has never been brighter thanks in large part to strong support of basic science, the foundation for discoveries that have long made america the world leader in biomedicine. One exciting example is the brain initiative. This bold, multiagency effort is enabling development of Innovative Technologies such as what you see here on the screen to produce a dynamic picture of how individual brain cells and neurocircuits interact in time and space. This initiative will give us the tools for major advances in brain diseases from alzheimers and autism to schizophrenia epilepsy and traumatic brain injury. Scientific advances are also accelerating progress towards a new era of Precision Medicine. Historically, doctors have been forced to base most of their treatment recommendations on the expected response of the average patient. But recent advances, including the plummeting cost of dna sequencing, now make it possible for us to apply more precise approach that takes into account individual differences in genes, environment and lifestyle. So with this in mind we at nih are thrilled to take a lead role in the multiagency Precision Medicine initiative. In the near term, this initiative will focus on cancer. Such research will include efforts to understand why cancers develop drug resistance, explore noninvasive ways of tracking therapeutic response and its new treatments aimed at the genetic profiles of a wide range of cancers. As a longerterm goal, nih will launch an unprecedented National Research cohort of one million or more volunteers who will play an active role in how their genetic and environmental information is used to develop new strategies for disease management and prevention. Theres no better time than now to embark on this enterprise and move this precise personal approach into virtually all areas of health and disease. In closing my opening remarks, let me share a story that highlights the promise of Precision Medicine and puts a human face on it. Seven years ago at the age of 12 alannah simon received a devastating diagnosis a rare and off fatal type of pediatric liver cancer quite a mouthful. This disease was poorly understood, and there were no effective drug treatments. Alannah was fortunate to have diagnosed early enough that with surgery to remove most of her liver, she successfully beat cancer. But the story doesnt end there. Four years after her surgery alannah began interning in her fathers lab at rockefeller university. Reaching out through social media, this determined young woman found 15 other individuals with this same cancer. And their tumors, including hers, could be subjected to complete dna sequencing. The results were nothing short of remarkable. Alannah identified a genetic mutation that appeared to be driving the cancer in all of the cases, every single one providing a target for a decipher drug that is now designer drug that is now under active development. Since then alannah has published her findings in the journal science, participated in the white house science fair, entered harvard and introduced the president at the white house launch of the Precision Medicine initiative. This is the kind of scientific success we want to see replicated over and over. With your help, the time is now to accelerate the pace of such breakthroughs. Thank you, mr. Chairman. My colleagues, who id like to briefly introduce and i welcome your questions. Over here to my left, dr. Tony fauci, dr. Gary gibbons, director of the National Heart lung and Blood Institute dr. Thomas insel, director of the National Institute of Mental Health, dr. Doug lowy who has recently been appointed as the acting director of the National Cancer institute and dr. Jon lorsch, institute of medical sciences. Thank you. Thank you dr. Collins. Well start with fiveminute rounds, and well probably have as many rounds as we can while weve got this great opportunity to talk to you about what youre doing on Precision Medicine. Obviously, a long path into the future where Precision Medicine might very well define most medicine at some future point. But what would you see as some maybe five and tenyear shortterm markers to look at to see whether were getting where we all would like to get as we move toward this Precision Medicine initiative . Very much appreciate the question, and this is something that were all quite excited about. Actually, we just concluded yesterday a twoday public workshop trying to map out exactly that kind of issue what kind of uses could a cohort of a million individuals be put to if that were present five years from now. As an example we really dont at the present time have the ability to take full advantage of what weve learned about individual differences in drug response and and see how those work in the real world. The fda has on the label now more than 100 drugs, information that say knowing the Genetic Information about the patient would be useful in this situation in order to choose the right dose and make sure its the right drug for that patient. But in practice thats not happening. The logistics arent there. Imagine, though, you have a Million People whose complete genomes have already been determined with their full participation and permission and are available then with the click of a mouse so that when a decision is being made about writing a prescription, its possible for the Health Care Provider to immediately know whether the dose needs to be adjusted or whether thats just the wrong drug for that perp. We could then for that person. We could then rigorously test what is gaped by that Additional Information in terms of outcomes in a large scale study of this sort which is currently not possible would make that happen. That would be an example. I want to turn to my colleague dr. Lowy, because the other part is this early focus on cancer which, i think, will reap rewards maybe even sooner than the process of getting this million cohort underway. Thank you dr. Collins. And thank you senator blunt for your comment and your strong support for nih. We really are at an Inflection Point where it comes to Cancer Treatment as a result of the genomic revolution. We now understand in much more detailed than ever before that cancer, instead of being one disease, even breast cancer, for example, is many different diseases. And the opportunity for targeted treatment that we hope will be better smarter and have fewer side effects really is at hand. We already have several clear examples of targeted fdaapproved drugs that are able to do just that. With the new Precision Medicine initiative, we are able at a much larger scale to be able to conduct Clinical Trials that involve both adults and children that instead of being focused principally on the organ site where the cancer develops, instead is focused on the abnormalities in the cancer and the targeted drugs treat those specific abnormalities. I have gone into this in more detail in my written comments, but i just wanted to highlight for you some of the key elements. Dr. Collins the millionperson coto horse how would you cohort, how would you intend to assemble that and put that information together to start with . Well, thats very much a topic of intense conversation right now. We have put together a working group of experts who met this week and who will meet again each month between now and august and, in fact, the next meeting which is actually going to be in senator alexanders state in nashville at vanderbilt will look at this very question of whats the ideal kind of cohort that you want to achieve as far as demographics. We believe that we can accomplish some of this by taking advantage of cohorts that have already been put together by various Health Care Delivery systems or perhaps by the Veterans Administration and therefore, be able to do this more cheaply than if you had to start from south korean. But up doubtedly from scratch. But undoubtedly there will be gaps. We plant to make sure this has we want to make sure this has power to tell us about Health Disparities. By august this working group will make strong recommendations, and we will then be ready starting in fy16 which, of course is not far away to initiate the process of putting this cohort together. Thank you. Senator murray. Let me just follow on that millionperson research cohort. Its very intriguing, but it has to be done right. How do you insure that it successfully represents all elements of the u. S. Population . Women . Minorities . So we very much want to have that kind of ability to sample across the population. Obviously, women and men obviously, multiple different racial and ethnic groups, across socioeconomic status, across age. Yeah. And with a million, of course, youd have the opportunity even in some of those subsets to have a lot of people involved. Thats the point of this, is having that kind of power. Exactly how we do this is what weve charged this group with wrestling with. I think we might want to oversample certain minority groups in order to be sure we have enough representation to be able to have powerful observations made possible about Health Disparities. And, certainly, we will want to be sure that weve involved women in at least 50 of the population that gets studied. One more thing i should say we think of the participants in this particular study not just as subjects or patients. Theyre participants. Theyre our partners. They are going to be at the table as we design this study and are already at the table. And i think thats going to be critical for defining the nature of what were about here. Were asking people to be volunteers, were asking them to share information. Theyll get back lots of information as well, but we want them to feel like this is an Important National program being part of it is something to be proud of. And how long will this take to to assemble the cohort, to put the million together is not going to be an overnight effort. We would guess this is going to take at least three or four years to get the entire cohort put together, but we would hope, of course, to be able to begin to learn things from it even before weve reached that very large number. Okay. I wanted to ask you a specific question. Your budget noted that recently two studies have come out one here in the United States and one in germany, suggesting the rates of dementia are falling. Thats really intriguing and sort of unexpected. And if its accurate, its very encouraging. What is nih doing to confirm whether those trends are real or not . So senator, we observed those papers as well with great interest. It was surprising. I think there is a reason to be a little skeptical about whether one can completely be confident in the conclusion which, if true, would be quite important. Because much of this data is based on dearth certificates and as we all know death certificates, and as we all know, up they dont accurately record the cause of death in individuals with dementia. It may say pneumonia or Heart Failure when, in fact, the primary problem was alzheimers disease. The National Institute on aging actually, does have two different studies underway to try to see whether in a rigorous epidemiological analysis whether there is evidence to, in fact, point to that decrease in incidence or whether some of this is a diagnosis issue. It is possible because theres a vascular contribution to alzheimers disease, and perhaps were doing better now in managing things in that category of cardiovascular disease that that might have resulted in a diminution in incidence or at least a delay in onset. But we need to know the answer to that. I appreciate your raising it, a very hot topic and discussion right now. I think its intriguing and especially if its true and it works and its related to vascular and we learn something i think that would be outstanding. So ill be following that too. I wanted to ask you since 2009nih has been monitoring the disparities between application success rates for experienced investigators versus earlier stage investigators. I mentioned this in my opening remark. As you know, the latter experienced a significantly lower success rate compared to our experienced investigators. While its always been challenging, we know that, im very concerned that its much more so for those scientists and physicians who have just completed their training and may end up driving promising talent from the field. Can you tell us what you are doing to level the Playing Field in terms of experienced and less experienced investigators . Senator i appreciate the question very much because this is something that i think troubles all of us. Im going to ask dr. Lorsch, whos director of the general medical sciences where a lot of our training support is doing to answer the question. So we are very concerned about this, senator as well. Were looking at a number of different ways to address it. In addition to targeting the first application of new investigators, i think a critical stage is also their renewal. If you get them into the system and then they arent able to renew their application, thats a significant vulnerability for them. So were going to be looking at that stage as well. Weve also started a new funding mechanism pilot which is a single grant per investigator. We think its going to be considerably more efficient in terms of getting taxpayers more for their money and also more flexible and stable for investigateors. And we will be, actually, in the near future rolling out a new investigative version of this pilot program. Okay. I think this is so important. We want to inspire people to come in they think theres no chance or were losing a lot of our knowledge as we have an aging cohort. I think thats troubling. And if i may say i think theres no magic that will really solve this as long as the budget continues to decrease, because thats affecting everything, and certainly were doing everything we can to protect those early stage investigators, but theres only soften things you can do. Thank you. Thank you, mr. Chairman. Chairman cochran. Mr. Chairman, thank you. Dr. Collins, i see you and think back of our trip to mississippi where you reviewed the results with local researchers of an idea program that indicated to you, i think at that time that there were opportunities for accomplishing breakthroughs in medical Research Among economicallychallenged citizens, and i wonder whether the nih grant Success Program and process has resulted in funding that has led to breakthroughs in research more cardiovascular diseases which seem to target africanamericans in greater numbers of percentage of the population than others. What is your latest information you can provide the committee about the need for continued funding for that program . Well, thank you senator. The idea program is one were very proud of and which gives an opportunity for funds to be made available through several different kinds of programs, the inbray and the can cobray to states that do not have as strong tradition in terms of researchintensive universities but who still have remarkable talent within their state borders. And im going to ask dr. Lorsch, who oversees the idea program now because its in his institute, to say a bit of a word about how that program is going. Were actually quite excited about it. So thank you very much. The idea program is one of my favorite things to talk about so i appreciate the opportunity. As you know, the idea program aims to insure that cutting edge Biomedical Research is being conducted in all 50 states in the nation. And i think the easiest way to see the importance of this program is to think about what Biomedical Research would look like in this country if it were not being conducted across the nation, if it were, say, only in 25 states. And if you think about every dimension of Research Whether its the kind of Research Questions being asked the approaches used to address those Research Questions or very importantly our ability to attract young talent into the system something senator murray addressed as well those things would all be diminished dramatically if Cutting Edge Research were not going on throughout the nation. And thats why were very committed to this program, and we think its really an essential part of our portfolio. Thank you. To follow up the actual request is it your intention to make a formal request for additional funding, or what is the status of the administrations position . So the idea program in the president s Budget Proposal for fy16 is the same as for 15 and the reason for that is that there was an exceptional increase for the idea Program Going from 13 to 14, and were now just trying to normalize those kinds of trajectories for all parts of it. But you should not take in any way as a diminution in enthusiasm. Senator, you also asked about cardiovascular disease and what that effect has been for minorities, and i cant help but say the place i often go to look for information is also a place you and i visited in mississippi, and if its all right, i might ask dr. Gibbons to Say Something about the particular study. Thank you. Thank you, dr. Collins and senator. As youre aware weve made tremendous progress in bending the curve in reducing coronary disease in this country by over 70 over the last 50 years. But theres still pockets of communities and segments of our population who have not enjoyed the fruits of those advances. Including africanamericans, particularly africanamericans in the southeast. In the jackson heart study, its rae emerged as really emerged as a National Treasure in providing us with an opportunity to further understand what are the drivers of these disproportionate burdens of disease in africanamericans. Indeed, one example id give you quickly is that we recognize that theres a great prevalence of end stage kidney failure amongst africanamericans, fivefold more than the rest of the population. Often driven by high Blood Pressure which is very prevalent. But thanks to the jackson heart study and advances were making in genomics, were now discovering and Funding Research thats discovering the genetic basis of this predisposition, identifying genes and, indeed sickle cell trait something that was previously thought to be relatively benign as important contributors to these Health Disparities. Moreover, these pathways give us insights into how we might actually prevent this disease and actually bend the curve, a key driver of, again end stage renal disease and expenditures for health care in this country. So again, you should be quite proud of this National Resource in jackson mississippi. Thank you very much. Mr. Chairman . Thank you. Senator mikulski m. Thank you, mr. Chairman. Dr. Collins and all of you, were so glad to see you once again. And we have talked among ourselves under the leadership of senator blunt we would like for the subcommittee to be able to visit nih so they could talk in more depth and more firsthand to see the great work thats being done by the people who work there. And, of course, if youre the senator from maryland, hopkins and university of maryland. Were glad to see you longstanding friends like dr. Fauci to new friends. Were going to get right to my appropriations question. The president has put in his request a 1 billion increase. I want to know what that means and is that enough. I understand that nih has lost 20 of its purchasing power since the doubling ended in 2003 due to inflation. Im concerned that, yes though you have more than the management capability to set priorities youre going to have to end up picking winners and losers. Winners and losers in the United States of america. You cant doll up in nih just because theres a headline or a world crisis. We turn to dr. Fauci and your leadership during the ebola crisis, and weve turned so long from aids, other issues and so on. You cant dial up a National Institute of allergies. We want to cure for alzheimers, and we want it yesterday. We all share that, all around this table. But with the resources that you have, im concerned. Im concerned that while we go for Precision Medicine which i support i worry about zip code medicine. The disparity in baltimore this morning between the neighborhood in which i live called roland park and a neighborhood called harlem park where they film the wire about two miles from where our disturbances are occurring, its a 22year Life Expectancy even controlling to violation. Ill live to 8892. That dear lady and that church lady is going the make it maybe to 6872. I could go on about it. As you know, weve got a lot of issues here. Dr. Thornton, our superintendent of education talked to me about the 85,000 kids that went home fine on monday, 300 created disturbances unacceptable. But we talked about how damaged our children is. I said what do you need in the School System . He said Mental Health Mental Health Mental Health. Either my kids are addicted, or their caregiver is addicted. So what is a billion dollars going to get you to help america with what all we need to do . I dont want to pick winners and losers between the 26 institutes. What is it that you truly need to do the job you need to do to serve america while were trying to do ours . Senator, thank you. Very sobering, indeed, the stories that youve just shared about whats happening in baltimore, and i think all of our hearts are deeply troubled and wish for the best for that tine fine city. For that fine city. We have seen over the course of the last 12 years a significant diminution in nihs ability to do Research Across the board and our most important resource, the people doing the work, are clearly pretty stressed at the moment. If you try to plot out what the reasons for that are and i show you a graph up there, the yellow line is basically what our purchasing power is for Biomedical Research going back to 1993. And you can see there was that doubling between 98 and 2003, but since that time we have steadily lost ground. The sequester added an additional severe blow to our ability to get our work done taking as it did a billion and a half dollars away in the middle of a fiscal year and from which we have not fully recovered. The billion dollars in the president s budget would go a long way towards putting us back on a stable, upward trajectory and weve waited a long time to be able to achieve that. It would allow us to give 1200 additional grants in fy16 compared to the previous year, and that would be welcome indeed. It would allow us to do things like the Precision Medicine initiative which, as i said earlier, we would very much want to have focused on looking at Health Disparities with the ability to really not only get answers as to causes, but to come up with implementation plans for intervention. So the billion would help, but what would lifting the caps do . Well certainly if you look at that diagram, you can see that we are down more than 10 billion over where we would have expected to be if wed stayed on that dotted green line which was the trajectory for nih going back to about 1970. So its going to take quite a bit to make up that ground. The other thing i might show you is the consequence of that for people who are trying to get their Research Funded by nih. Thats the success rate. Thats what an investigator whos sent their grant in to us is facing. And you can see going back a couple of decades thats traditionally billion in the range of 70 2535 . But more recently with the flat budgets influenced by inflation were down in the zone of 1617 . Which is very unhealthy and has caused i think a great deal of people dont understand percentagings. What is the number . The number of grants . One out of six would be funded at this time. And how many do you turn away . That would be five out of six, so but is it 200 . Is it 2,000 . I see where youre going. So the number of grants that we fund in each year at the present time is about 9,000. So that means we are turning away about 55,000. And you know what . I dont think i can tell the difference between a grant that just made the cut and got funded and one that missed it, because in that zone theyre all terrific. And so we are leaving a lot of great science maybe half of it on the table which we would not have done in past years. Thats a stunning number. Are yes. Well, my time is up. I think weve made our point. You need at least a 5 increase to stay in place and to begin to catch up. Thank you, senator mikulski. Senator moran. [inaudible] id yield to the next republican or democrat senator alexander. Thank you senator moran. Mr. Chairman the problem is i cant find my glasses. [laughter] good. [laughter] before he finds his glasses, dr. Collins [laughter] i think weve just seen a parable about the importance of Precision Medicine. I was trying to think of how to do that, and i want my 30 seconds back. [laughter] when we get to one minute i want to switch to a red tape topic, but to begin with let me start with where the other discussions are. I went to the Precision Medicine announcement that the president made to demonstrate support for it. You were there. Senator murray and i are incorporating the president s proposal into one of the Top Priorities of the help committee which is our innovation effort with which were working with you about. How important would a properly functioning Electronic Medical records system be to your effort to develop a cohort of one million individuals so that you could sequence their genomes . Senator, it would be enormously important. Were counting on being able to utilize the advent of electron aric Health Records to make this electronic Health Records to make this possible. Recognizing at the present time theres a lot of work to be done in terms of having those become truly interoperable right. But the faster we get that going, the easier it will be to do what youre doing, and i would assume you mentioned clicking the mouse if youre a doctor and youre prescribing a medicine, you want to find whatever Genetic Information is. If the Electronic Medical system isnt operating well, makes that more difficult s that right . Exactly. And many doctors are a bit frustrated about this. Theyre really us from rated. Really frustrated, yes. Your institution vanderbilt has been i think, in the lead here in looking at ways to try to make this system more optimized which is one of the reasons were bringing our workshop to that institution. They do a terrific job, but probably within vanderbilt that is, well, were going to work on that and the administration and senator murray and i are setting up a working group to identify the five or six steps that we can take to improve the Electronic Medical records system. So well be working with you on that. The day you and i visited last week on the same day dr. Interrupter in came by, whom id never met which i thought was interesting because if ive got it right the two of you led parallel efforts to sequence the genome, one public, one private. Right. He said to me that his institute in california also plans to identify a million individuals and sequence their genomes. Now, based upon the experience that you had earlier when you were working parallel, side by side, is there any is there anything comparable about what hes doing, what hes planning and what youre planning . Is there anything to learn from the early experience about collaboration . Thats a lot of sequencing. Are they just completely separate, or do we know yet . I think there are wonderful ways to make this a collaboration. I ran into him in the hall waw after he had just been visiting with you and, of course, ive been in touch with him repeatedly over the years and recently made a plan to come and visit his Human Longevity institute there in california. Exactly what his plan is in terms of who the Million People are that he will be sequencing hasnt fully emerged, so everything is a bit of a work in progress here. But i promise you theres so much to be gaped here by work to be gained here by working a way that this this can be collaborative. One thing we will be very clear we want this to be a project where scientists, researchers with great ideas are going to be able to get access to the data as quickly as possible because this will be incredibly valuable as a resource, and that will be an important part of what we work out. Well thats but its an Interesting Development and huge, i mean, a million, million individual cohorts i mean, has that been done before . No. Your list of regulatory obstacles or administrative obstacles that make it harder for you to succeed. You mentioned youd like to have the money we appropriate for one carried over to the next year. You mentioned the amount of paperwork you have to do for scientists to go to conferencees. You mentioned five or six or ten other things. Some have to do with what the office of management and budget requires, i assume. Some has to do with things we do. I would like to invite you to give those specific recommendations and see if we can fix them. This Innovation Project means well have a law passed and we can clue include some of these things. Id like to include what we can do about the National Academy of sciences that 42 of the time an investigator spends on a grant is administrative work. You get 24 billion for research you give to universities. If we could russ by five to ten percent the amount that is spent on administrative work, my back of the envelope message theres a bill dollars. The senator was asking about a billion doors. Theres a billion dollars which could be used for mow grant. Invite you to work with us on that. While were trying to appropriate more money we might be able to save money and that would double the amount of money that would be available to you. Senator id be glad to mitt that list and i appreciate what and you senator murray are doing with this Innovation Project. This would help a lot. Mr. Chairman, said double the amount of money available. It could the savings myth double the amount. Thank you. You got your 30 seconds back and a little bit more and everyone is doing a good job to hold to their time and well have a second round. We would like that information when you put it together, senator collins for this committee as well. Senator durbin. Let me just say at the outset address my colleagues here. Gathered in this room at this moment are the key players in the United States senate when it comes to this whole issue of medical research. Senator alexander is chairman of the Health Committee or whatever the name is with his Ranking Member senator murray. Senator blunt is chairman of the appropriations committee, along with senator measurery. My overall champion of the committee, thad cochran and we have an opportunity here. We know that American People are skeptical if not cynical bat who we are or what we do, but if you had to pick one hearing room that virtually every visitor and every family would be interesting in hearing what going on, it would be this room there isnt one of us who isnt vulnerable to some medical diagnosis for ourselves or someone we love that could be life changing and we pray when we look in the eye of the doctor and say, there is anything you can do, he can say youre in luck. We have new drug, new surgery a new approach. Can i suggest to my colleagues here on both sides of the aisle wouldnt it be significant in our lives and in the history of america if we decided to be the driving force to make certain that we make a statement once and for all about Biomedical Research in the future of this country, rather than let it be tossed about by the whims of budgets year in and year out. I look at senator cochran our defense appropriations subcommittee, i chaired it before you. I said ike going to focus on medical research in the department of defense. The first year we increased medical research by 28 . The second, 11 . And ive contacted dr. Collins and said are we able to coordinate this so the flagship, nih, can work with the department of defense the cdc the department of veterans affairs, even the department of energy, to make sure were moving in that direction. Before i ask a question, i just hoch that as we thing about, for example, an infusion of funds strictly limited to the Defense Department that we stand our ground here and say it wont be strictly limited there are some things that need help and this is one of them, and we want to put in our bid and make our stand to make sure that the medical research, Biomedical Research starts moving forward again. Dr. Collin suggested to me, five percent reel growth for ten years. I wish we could do more. Some are calling for more. I urge everybody here because gathered in this room are the people who can make the decisions. Can i ask you incidentally, congratulations, having been chosen to be a member of the Irish American hall of fame in chicago, illinois, on saturday night. Congratulations. Are we coordinating this Research Going on across the federal government in medical research . Thank you, senator. Yes, i think can say with considerable detail and confidence that we are. You mentioned the interactions of the department of defense and we spoke about that, and we went back and looked very carefully at our portfolio and theirs to identify where there were areas that or were dupe application and we found synergy and great examples of places where a particular problem was getting funds by oath ages but covered different parts of the problem. We also are working more closely, i would say than probably at any time in history between agencies like fda cdc the cms where we just recently last week had a meeting of senior leadership, and with darpa, where were working in a variety of interesting ways to develop a combination of engineering and life science approaches carrying with me today three different organs on a chip. This is a blood brain barrier and this is a kidney and this is a lung. There are all basically taking advantage is that water. Just happen too have it here. And thats a collaboration with our trying to put basically a lot of human biology on a chip to enable us to be able to test new drugs, for instance to see whether theyre toxic or not. I dont have enough time for you to give an adequate answer to this, but yesterday i was visited by a pretty well known lady name Barbara Streisand who is pushing for this area of research to make sure that women are included in Heart Research and trials, and she believes that adequate attention has not been paid to this area and some share that belief. So i hope were thinking about the appropriate diversity in the testing to be able to come up with the results that help all of us across the country. Senator particularly agree with you. Ive also met with miss tries sap and she is a very streisand and she is an important advocate. One thing we have done is to insist that people who are funded by the nih who looking al animal models have to styled male and female. They traditionally only study one sex and thats leaving out important insight. Mr. Chairman, dr. Collins i can see you earlier but i cooperate see what was in front of me. Thank you for you being here, your colleagues. Dr. Collins, you were in my office late last week, i guess and we had a conversation. I want to ask you to follow up on the conversation that we said kind of if someone can humbly give you an admonition. I tried to give you one. You talk about in your testimony the Stewardship Initiative at nih in my view theyre related. And i want you to tell us again tell news more detail what youre indicating in your testimony about stewardship at nih, but i want to reiterate what i indicated in my office. Many groups, people, individuals, folks afflicted by every disease ask members of congress for help at nih to find a cure, and a solution to their health and their lives. We have had taken the opportunity to defer to nih to make the decisions about prioritization of medical research. The theory before i arrived in the senate, that scientists should make the decisions about where the most promising opportunities are in finding the cure or the treatment. But what i want to know from you is that you are fulfilling that responsibility. That nih in the absence of congress direction about where to focus the dollars that nih is making the best decisions possible to find the cures that are the most readily available and most demanding by our citizens and the population of the world. In other words, if you dont do that prioritization, then i think its going to become incumbent upon congress to make decisions that are better made by you. Senator i appreciate your raising this issue. Its a very important one. And even as we hope and pray for a lifting of sequester caps that would allow nih to get back on a stable trajectory as well as many other important activities of the government as well, we take very seriously the importance of enhancing our current focus on stewardship to be sure that we are paying absolutely close attention to how every dollar is spent. And so over the course of the past many months, looking at areas of that sort, we have in fact quite a vigorous plan here in terms of how to put forward those stewartships. Stewardships. One is to develop an overarching nih plan covering our entire 27 institutes and centers each of which has had it open Strategic Plan but we have not had those send that sized into a document that can guide our priority decisions, and well have that and submit it by next december. We also can use new methods that are actually much more sophisticated than what we had in the past to a portfolio analysis and see exactly where are our dollars currently going are there governors areas where we piled up things in some spots and not enough in others. Were going to look closely at our portfolio of hiv aids research. We desperately need to find an answer to this disease and end this epidemic. We need to focus on vaccines, on new forms of therapeutics, on only the cure. We have active grant by grant review going on right now of our hiv aids portfolio to see how that matches with the priorities that should be most appropriate at the present time. Were going to make sure that we have best practices for how funding decisions are made win the institute because peer review is part not at all of that. We have to make decision based on scientific priorities that we are responsible for and we want to make the most of those tubs. We will continue to look for partnerships so that as much as possible we can find other dollars beside nih dollars to pursue important projects with other agencies or the private seconder well focus intense hi on early stage investigators which have been raised as major issue and one wore very concerned about how could be enhance the tub to give the opportunity to give those investigators the confidence theres a career path for them and they can take risks and do Innovative Research without fear of losing support and as was mention bid senator alexander were going to look closely at administrative burdens many of which we dont control but for the ones we have some say over were going try try to reduce those and give scientists more time to do science instead of paperwork. Thats a partial lives but i want to assure you very much from my own personal commitment here that we are taking this with great seriousness. We dont expect people to say oh well, youre just nih so you deserve dollars. We have to show were using those wisely and every dollar i being put to good use. There will be much more to say in the coming months. I think as you heard from senator durbin and every member that has spoken, were interested in finding Additional Resources for you. We understand that this issue cannot be resolved only by your efficiencies, but as we find those additional dollars the assurance that i was am looking for is you then have the capable to make the decisions where those dollars can best be spent for the best outcome for the health and wellbeing of our country. And i thank you for your answer. Thank you senator. Thank you mr. Chairman. Thank you dr. Collins. Ive become increasingly about in telehalve and there are a number of federal agencies doing great work in this space at dod and the va comes to manipulated. Cms has some work to do. Some has to do with their statutory challenges and some of that i think they can push their authorities at built more, and i know that nih is doing a number of research projects. I wonder if you wouldnt mind taking a number or two and let us know what youre up to and what you found. Many institutes have investments in this space and i got to tell you that more recently what is really emerged as an even more hot area and a very prompt missing one is the promising one is the idea of m health, using Cell Phone Technology to make this transportable where people are Walking Around with their own telehealth gadget in their pocket and thats what we want to test in the pree Precision Medicine. The iinstitute is trying to state with babies and newborn which of those are developing a retinopathy by basically taking photographs and then sending that to an expert across the country to say thats bone needs treatment, that one doesnt. Dr. Gibbons has a telemedicine application for asthma. Do you want to say word about that . Yes. Certainly one of the areas of concern with asthma, leading chronic condition affecting children relates to being able to tran sed the Rural Communities where theres a problem and a lot of times its getting a sense of the childs symptoms. And thats an opportunity to use leveraged technologies that enable that information to be to get to the experts necessary to manage that care. Other technologies that actually exist on a smartphone now theyre able to assess the breathing capacity of the child. And we have funding that leverages resources that are lore such as schools. Where this information can be ascertained. The childs symptoms and disease course develop and a treatment against, transmitted in that local environment. Leveraging those local resources. So were looking at using these new mobile technologies in different ways to enhance care for both children and adults. Thank you. Let me just make a small point about telemedicine, telehealth. This has been something that people have been work on for decades and as a result people thing of vtc or telemedicine sensor based delivery of care, and i think that its entirely possible that, for at least some too much h treatments the mobile phone outpaces off another that. We encourage your to do telehealth, were not cop seiving a 1995 center for telemedicine but were enabling people to get the health care that they need through their phone, and hipaa compliant. We have a statutory infrastructure and some inertia that is based on what was possible ten or 15 years ago. Senator, im glad you point this out. Our nih portfolio has shifted dramatically in the direction of mobile health, Cell Phone Technology, which is bursting for potential for either maintaining health or for perhaps using this to monitor chronic illness many of us Walking Around with wearable sensors, something that is monitoring their physiology. Thats such a great opportunity for medicine and were all over that. One other question with respect to telehealth. I think were going to come up against the question of scoring. I think with respect to medicare reimbursing for telehealth services, theres an ongoing discussion about whether or not it will increase total costs to the system. My strong belief is it will decrease total cost to the system. That doesnt mean that cbo scores it accordingly and im just wondering whether youre doing any research that gives us any insight what would happen to total costs in a Healthcare System utilizing mhealth. Were interesting in regularrous studies to determine whether mhealth player,s are improving outcomes. Theres so many potential applications out there but many of them have not been put to a test and in order to decide whether youre achieving any cost savings first you have to figure out did this application actually improve the longterm outcome. Did you reduce illness . Did you manage it more effectively . That is very much in our sweet spot in term what were trying to support. Thank you. Senator. Thank you. I want to thank the panel. This is very interesting to everybody. Im just going to make a quick comment about the idea program that youre in charge of. Two of our institutions in West Virginia. Wvu and marshall are the recipients of grants there. So id like to invite you to join me in West Virginia to show me what is going on and what the possibilities are there. I would be delighted to come. Do good deal. My real passion here in the area and the is alzheimers. Both of my parents recently passed away, both of them had increasing dementia. Im going to go back and look at the death certificates and see what was actually listed as the cause of death because having lived through it, when you said it may be decreasing, my eyes almost popped out of my head. What i saw on the ground i cant imagine thats the case and it could be just poor data. And i hope that i know you are getting ready to revise a Research Milestones for the national plan. Could you talk a little bit about that . What nih is doing in that area . So, alzheimers disease is an area of intense focus and has of course enormous consequences. We need to find answers here. Five million americans currently affected. The cost permanently to those individuals to their families, is enormous. The economic costs we know is approaching 200 billion a year, just in the United States. So we need to find ways to prevent or delay this disease and there is effort across many different parts of nih to do so but led by the National Institute on aging. This extended from very basic science studies trying to understand what is actually happening in the brain that leads to the deposits of proceed teens, am an Interesting Development is called alzheimers in a dish, the ability to take stem cells add an appropriate cocktail to convince them to become neurons and put them in a dish not as flat cells but in a threedimensional space where they act like they would in a normal circumstance, and you can tell the difference between the cells if they came from somebody with alzheimers as opposed to a normal person. That gives us a chance to look in human cells what is really going on in a way that doesnt put people at risk and allows, for instance, screening drugs to see which of to the might most promising. Thats the basic part of it. The clinical side, i think just a month ago the report by biojengen of what appeared to be a possible positive approach from an antibody has got an lot of people interested, and whether we might be on to something. Now, very small trial only 300 patients. Always got to be careful here because its so easy for those things not tend to up being replicated but the initial excitement is certainly something that with cautiousness people are feeling a bit more optimistic about. One thing we are doing is to partner with industry, and an unprecedented way. Is that the accelerating yes which involves ten pharmaceutical Companies Working with the nih on also himes, diabetes resume today arthritis and lupus, and i cochair the executive committee of the group and we have only been at its year and were ahead of the schedule we thought would be possible. And that is showing promise from the basic to the clinical. I thick were on a roll here in terms of tackling what has been for most of the years we have study it it a really frustrating disease. Were starting to get a much better handle on what is going on in the alzheimers brain. Its clear that one thing we need to do is to start early before too much damage has been already done to the brain. So i assure you this is an intense area of focus. I would encourage that. Would be a great supporter of that. I just read an article i believe in the sunday paper about a Clinical Trial a small area, i believe in south america, that identified the they had a pocket of early onset alzheimers in the 40s age bracket, very interesting to me because it mentioned some of the same things you mentioned. Thats an nih sponsored trial in colombia for families with dominantly inherited form of alzheimers. Could learn a lot from that. A. Theyre involved in the Clinical Trials. The interesting thing having lived through it with two parents simultaneously, its not the same for every person which makes it more difficult in terms of researching and figuring out how to attack it. So theres a lot of families across probably every family sitting up here today and the audience has been touched by this. Thank you for your work. Thank you sir. Senator baldwin. Thank you mr. Chairman. Thank you and welcome. I want to start asking some questions about chronic pain, opiode treatment and alternatives. Let me just give also built of context. Obviously we know that chronic pain is a condition that affects over 100 million americans and for some individuals prescription opiodes or an important part of the treatment plan but its also clear if you are following any of the trends in the nation that were in the midst of a National Crisis as a result of significant overprescription of opiodes, and misuse. Dr. Collins, you recently stated in i think a blog post that when it comes to chronic pain, opiodes are not always the answer and speaking to the lack of evidence well, what did you say that theres an absence of unbiased scientific review to examine evidence of the safety of longterm prescription opiode use and the impact of such use on patients. So id like to talk first on just two questions related to that. First is please tell us about the collaboration er doing with the va on inquiry into alternative Pain Management strategies. Not just for physical pain but also ptsd. And then in what time you have remaining, if we do, what potential does the research on the effectiveness im sorry what does the latest science tell us about the broad use of opiodes to treat chronic pain and what is the nih doing to advance our Scientific Understanding of Pain Management. Thank you senator. This is indeed an enormous concern, an enormous Public Health problem, 17,000 people lost their lives last year to opiode over dose, most unintentional. The number of prescriptions written for opiodes add up to one prescription per american per year ask that doesnt sound like thats what we need to do in order to deal with the problems of chronic pain. It is in fact the case that studies that have been done on the use of opiodes and chronic pain have not been carried oat more than four to six weeks and chronic pain often goes on longer than that. But the data we have would cause anybody to conclude that opiodes are probably not a good choice for chronic pain, unless its associated with severe tissue injury as in the case of, say cancer. We have a lot that we need to come up with in ems of al alternatives and thats the 13 projects with the vair, va, and the National Institute for drug abuse are working together on this. I think they are trying to assess for various types of pain particularly if its called central pain coming from conditions associated, for instance with ptsd, where the use of a drug like an opiode, which is better suited for peripheral pain, just doesnt seem to work, and in fact carries a lot of risk. So alternatives such as antididntants,ogy anitive behavioral therapy, i intervention that involves something that might seem new age but actually seems to have some value to a lot of people. Yoga all of those being looked as at alternatives to putting people down a very difficult path of opiodes which may lead to addiction and all the problems associated with that. Meanwhile, the National Institute of drug abuse is deeply engaged in looking for other alternatives for Pain Management that are not addicting, coming up withopiodes that cant be abused because they cant be injected. All of those are high priorities. I traveled to atlanta this year as i did last year, along with the head of the Drug Abuse Institute to this summit that is held every year and were there thousands of people there working together to tackle what everybody now sees as a major and growing Health Problem in u. S. Well do everything we can to help with that. I have just a couple of seconds remaining. Hopefully have you follow up in writing. One of the highlights that you focused on in your testimony was our shared priorities to improve opportunities for the next generation of innovators and researchers across our nation, and i know that you have initiated and we have talked much about the initiation of a number of policies to promote new researchers. We have identified a significant gap in the data on existing Research Work force and we have a lack of comprehensive way to track the success of the careers of researchers. I have been working closely with you on my next generation researchers act which would ensure that nih accelerates current and now policies to address this and foster new researchers. So let me just say that i would like to hear more about why we dont have a good system in place already to track this information on our biomedical work force and what additional steps nih is taking to address this gap. I think well take that for the record, when we get to a second round if senator baldwin wants that to be already question, that would be great. Senator cassidy. Gentlemen, im a doctor. Now so much what yall have down. In 1985 when i was a resident at Los Angeles County hospital, the diagnosis of aids was 100 death sentence. Now if you take your medicine youre more likely to die of alzheimers aids, so thank you from a guy who has seen what you have done. I want to build pop what senator moran was saying. When you said, dr. Collins the report will be available next december do you mean 2015 or 2016 in term office rebalancing your spending priorities. December of this year. 15, and theres an article from 2011 suggesting the principle variable in determining funding was disable life year and that account ford 33 or 39 of the variance and there was in 0 correlation. What other factors will you be using to determine whether or not you should rebalance fund organize how other to rebalance. Generally we look at the Public Health burden and tallies is a very well established way to do that. We also look at scientific opportunities because its not going to be successful to throw money at a problem if nobody has an idea about what to do about it. We look at what our peer review process is telling us about the excellence of the science. Now to a certain extent i dont mean to interrupt. I got four minutes and this guy is going ride herd to a certain extent theres a certain sort of the pass is prologue on that approach. When i look ill just tell you my concerns. Ive done some back of the1 2 figuring and we have been looking at this you. Mention the work being done for vaccine hiv aids, were spending 400 million for that and were spending less than 600 million in total for alzheimers. So for just the vaccine suspect of hiv aids, were spending twothirds as much as we are for alzheimers, on a perdeath permanent this is back of envelope were spending 100 almost 1,790,000 per hiv death and were spending 6,700 per alzheimers death. 10 of the budget on hiv aids, 1. 9 on alzheimers. I can go down the list. Im a hepatologist so theres similar numbers for alzheimers were spending you mention 00 billion a year for liver disease, 51 bill a year, and for hiv aids, all categories, 16 billion a year. So, there seems to be just a total out of whack in terms of the burden on society deaths, dallies, cost of met okay, medicaid, et cetera, and were overspend right now. Can you correct that install relatively short period of time . Well, i think our goal is to end the aids epidemic, and were not there yet. 50,000 new casefies year. I accept that but if you look at the incidence of disease theres far more incidents of alzheimers than hiv, and the means of preventing hiv is well known. Obviously vaccine would be the holy grail. So are we going to i guess my question is, we got this balloon note on alzheimers. 200 billion and climbing. Are we going to wait until we figure out a vaccine for hiv aids before we begin shifting to the new battle in which case you you see what im saying . I think i do. Again, i want to assure you that we are looking with more scrutiny than ever at the hiv aids ahead portfolio. I should ask dr. Touchy to way in here. Iups the point youre make, another variable when you talk about scientific opportunities is the ability or not to completely end something, and i think when youre teal with an Infectious Disease that has epidemic and pandemic aspects to it thats really a different story in some respects from other diseases which are eannually as serious as devastating and equally as serious impact on society that dont have the potential to actually be completely ended the way we did polio and many other ineffect shoes diseases. So though i fully understand and actually appreciate the point youre make, im looking forward to a time when im sitting in frontthis committee and end head the aids epidemic and you you wont need the money. I accept that. Thats a good point. But does that mean we increasingly consume because i income 2011 the bug for hiv aids was 2. 5 billion. And now its almost 3 billion. And so it just i just we have to set priorities, and were spending 300 billion a year on alzheimers dementia. It would be great if we spending 19,000 per death for hiv and 6,700 per death forearms homers seems like a prioritization which doesnt reflect we are seeping i get your opinion. Also to get this point on the table. I if you do the kinds of calculations hutch money you would save how much money you would save per hiv invex free vents and you do the that, youre talk about a vaccine that isnt the best vaccine in the world, 55 effective we would save 6 billion a year just on that. So those are the things were aiming at. The other point i want to make is when dr. Collins was talking about relooking at the portfolio, one of the first important steps is to look at the portfolio itself, and then say, within that portfolio are we actually spending money on the most high priority within that and make that as the first shift, and then take a look after that and determine about the redistribution. So we are looking at that and taking it very seriously. Thank you for your indulgence. One wrapup question on the alzheimers issue. I appreciate the conversation thats ongoing on this. This is one of multiple diseases that have a tremendous expense, diabetes cancer, alzheimers consuming a great deal of both financial cost and pain across the entire country. Last year, Congress Passed the alzheimers accountability act which required a report and to be able to get that budget estimate together, what would take. When do you expect that to be complete . I appreciate the question. Yes, this was an act which got folded into the omnibus bill which asked nih to put for what is called a bypass budget, and the instructions are such that we are to have the first version of that by sometime this summer in order for that to apply to been fiscal year 17 and were on track to too that. We will in the next 24 hours issue a new set of recommendations about Alzheimers Research based upon the summit that we held in february and the synthesis of those recommendations. That will be coming out tomorrow. Terrific. Thank you. Senator, i look forward to going through that report. Im like many people, i watched my grandmother do the long goodbye and we walked through this life together. Senator, if i may because we had this conversation about alzheimers and aids i would say we have actually increased alzheimers spending since 2011 by 40 . More than any other disease in the portfolio specifically because of the scientific opportunitythe enormous Public Health need. When senator schatz was talking about telemedicine, want to reinforce some things. We have work to do with cms on the billing process but let me do one caveat. This is not to belittle them at all so not picking on somebody that is not here. The Census Bureau pep 1 bill dealing a hand held twice to do the census and had to punt it so we lost 3 billion on the hand held device to take the census and evenly they went back to pen and paper. As much as we can use Current Technologies and allow the private sector take the lead on that and makeys of it, employs continue do that. When we go these other technologies dont reinvent the wheel. Im with you. In fact with this Precision Medicine interest theres enormous interest of various mhealth apps. We have no need to develop our own because theyre chomping at the bit to have theirs tried out in this kind of study. Thank you. Please press on with that. Met ask a general question. We see an increase in costs in drug and Device Development over the past several years. Without a cap. Can you help me understand what is driving the increased cost between basic research and clinical research, from the time of concept to the time of getting to the marketplace the key factors you seive that is increasing the costs more than anything else . I know its not one thing but if you can give me a couple ideas here what we should watch for what its driving the cost change. A lot of it is the high failure rate and that is in fact very troubling. When you consider how rarely an idea about a new drug makes it to fda approval, its less than one percent of the time. And so all that cost of the failures has to be added into the overall enterprise. One thing were doing at nih to help with this the formation of the National Center for advancing Translational Sciences which aims to identify some of the places where failure happens, where bottlenecks occur and develop new technologies in concert with the private sector to see what can be done about that. I mentioned this idea of human cells on a chip as a way of testing drug toxicity instead of using animals and that we woo be a big step forward where things dont work well. Another is this whole idea of Precision Medicine, where instead of trying to develop a blockbuster drug and finding it doesnt work when you you apply it to thousands of people, you actually identify the subset of individuals for. Who that drug is suited so cost of the trial goes down and chance of the success goes up. Those are all things in the works but i share with you the concern we have to turn that curve around and. Er is there any spot you see the cost increasing more than any eye area going from concept to actually distribution . Boy guess the clinical kyle, of course, is the most expensive part when you look at the where the dollars start to build up and if you have to do a Clinical Trial of thousands of people and follow them over a period of time, thats going to be very expensive. We have to come up with ways to do small are trials, have biomarkers to ahow you to know if the drug is work without waiting four or five years to see what happened. Those efforts are high priority. Thank you. Dr. Collins wanted to ask you about your opinion about a some work ive been doing to derive drive this Senate Appropriations committee to have one unified federal Electronic Health record between dod and va. My hope is to make sure that using the 25 million patients that the va has and the 2 million patients dod has we have one unified record. My hope we have this all with open code and open source to repeat the success that motorola had with the android system, where they had 70,000 apps from the industry that were written to the open code of android. Can you give me a comment on that . I will be coming to you with a stroke Net Consortium were putting together across illinois with five hospitals. I will say including barnes, jewish which is particularly good at working with nih. Well, im really my hat is off to you for what youre doing with the dod and va to try to make this into a seamless Electronic Health record. All people in the service are anxious to see that happen. Its been difficult with those transitions. This all fits together with a broader effort to try to see if electronic Health Records that are being collected on all of us can be made more enter operable so you can walk around from one state to the next and have your Health Records accessible when you need them. There is in our Precision Medicine initiative a great need for this Electronic Health record to be usable in the best way. Were working with the office of the National Coordinator for halve i. T. On that very issue of meaningful use. The white house has a new chief Data Scientist who is involved in the dodva records to get electronic Health Records to talk to each other. You would think this would be easier than it is. Its actually quite a challenge because of the way in which Health Records are not standardized where the information in them is often textbased and therefore difficult to do easy melding i interrupt you. I have put forward kirks pretty good plan that all imagery be j peg and all documents be ms word. And because those outcomes could advantage certain providers out there. My vision thing is because of va represents about 10 times the patients that the dod has that we good with the va standard. I really appreciate your idea of a pretty good plan because right now i think the perfect could actually be the enemy of the good. What we need right now is something that guess enough as opposed to what we have. This whole idea of the blue button where individuals can get their own Electronic Health record would be enormously beneficial if if was actually reduced to practice. Thank you senator. On two or the points and then go to senator murray. On the stewardship discussion. The 27 senators you currently have, have their plans ing this is the first tomorrow you evaluate and try to prioritize where you ought to go as you look at all of those 27 senators to really come up with an overall Strategic Plan. Die understand that correctly. Thats absolutely right you hope to have that available by the end of this year . By december, yes sir. Be very helpful. I want to just encourage you to do that. Im supportive of out. I think your efforts there the questions are better asked by you, frankly to start with. You have got those 27 practice are plans to look at. You have the forum to hash that out and have the internal argument you need to have about why this is maybe a bigger priority than that. And clearly i see this as responsive to the discussions that you and i and you have had with many other members of the committee about lets set down and hear from you about how to really prioritize this. On the alzheimers discussion, i think in the bill last year, the octobertive was for you to have a plan that would reach a goal by 2025. And that goal was what . To have a cure for alzheimers . Or a delay in the onset. A major advance in terms of preventing or delaying the onset. We should expect that report by when . I think you already said, im sorry. In terms of what we asked for in the to new omnibus is not only a plan but a bypass bug what it would take to get there the plan is refreshed every year and there will be a new version tomorrow. But we are also then going to attach that to a statement of what it would take to accomplish that because we have been asked to do so by the omnibus language. Will be seeing something tomorrow . Tomorrow you will see the outcome of the summit on research that was held in february bringing people from the u. S. And outside the u. S. To really nail down what are the highest priorities right now for research in this space. This will be the second time we have had such a summit and this is a major refresh of what at the Research Agenda is. I think the Precision Medicine discussion, the brain discussion and thinging extra Strategic Plan discussion make enough news for today or id press you on why cant you tell us today what youre going to tell people tomorrow. But i look forward to that tomorrow. Doctor ive been very interested how we prioritize Mental Health or bring it to the same level of all other behavioral havent to all other health issues. These statistics i believe is generally used now and always nih is the source is one out of four adult americans have a behavioral Health Problem diagnosissable behavioral Health Problem that is almost always treatable if its diagnosed. Is that number still a good number or do you have a better number we should be using . And i think in this case we tend to focus more on those who have the most disabling or serious enemy illnessed. Thats more like one in seven or one in nine, Something Like that total number of runs to about 17 million adults. But what is critical to remember in contrast to what talk about for alzheimers disease these are diseases chronic diseases of young people. 75 of that number have onset before age 25. That makes this a particularly challenging Public Health issue. We all heard senator mccull skis story today about how when talking to people at schools what is the single biggest thing we could do to help and this obviously is right in the area that youre working. If one out of nine is debilitating or serious what would be the bigger number of Behavioral Health that is diagnosissable and treatable . Across the board, about one in four is the number that we think about across the life span in terms of people being affected. The Armed Services committee i was on last year, Armed Serviceses a opposed to defense but i may have passed this. I asked the Surgeon Generals of the military if they thought one in four statistic was how to apply to people in the military, the answer is got was, we dont have any reason to believe its not about the same. We recruit from the general population about the same, and what has been happening in military is it relates to how we deal with behavioral Health Problems . Well, as you know, senator the suicide rate in the military turkly active duty, has gone up significantly doubled, actually century passed the civilian rate for people in the same age bracket. Its beginning to come dowling slightfully the last three years but we have gotten new numbers in the last couple of days so its still high. And dod and especially the department of the army have been very very focused on how to bend the curve there. We have been working with them through this stars project with over 100,000 soldiers over the past five years and that project has given us a much better sense of how to focus their efforts on those who are at highest risk. Thank you. Thank you. I wanted to ask you dr. Collins, i was noticed a very exciting announcement by nih to me that one of your researchers were some of your researchers were able to use fda approved drugs to activate stem cells in the brain to actually repair damage caused by multiple sclerosis. That is really exciting because up until now we havent been able to repair damage after its occurred. I want to ask you what this next step on that . That was an exciting finding basically the National Center for advancing tran layingsal sciences has this ability to take any kind of an as say you have developed and screen it against all the fda approved drugs quickly. If you could find a circumstance where you have a disease like multiple clear row multiple sclerosis where theres a drought that has been used for other things you can jump across many different hurtles to get to a clinical outcome the need to see happening for ms. So the investigators support bed the Neurology Institute did the screen using the kinds of cells that make mylan that provides the inlayings for nerves. And were able to show in a petri dish there were two drugs in the fda collection that seemed to show benefit in terms of stimulating to the cells to make the mylan and then they tried that in the mouse model and both of them appeared to have activity in the best animal inned 0le we have that means the next step would be to think about how to move this into a human Clinical Trial. One of the drugs is antifungal, the other is steroid but neither had been thought of so were excited about. They might also say theres another exciting finding in ms research in the last month. Dr. Fauc is institute supported an effort. That was a human trial. Thank you. The study that dr. Collins is referring to that we funded, the allergy and ineffect thus disease because its immunology ically based study. We took 25 individuals who had multiple relapsing ms and performed stem cell transplantation preceded by very aggressive immunosuppression in the same way you give a stem cell transplant for one with neoplastic disease. As its turned out to our great surprise and gratification the numbers were extraordinary. 80 of the 25 people in the trial went into a remission in the sense of none of that multiple relapse and that has been followed now for three years, which is really quite impressive. And although we also have a caveat the end is relatively small, 25, but 80 of 25 is really impressive. So were going to very aggressively pursue that approach. I am very excited about that. Thank you. Looking forward to more on that. And finally would just note we have been here almost two hours mr. Chairman and how time has changed. Six months ago this entire discussion would have been on ebola. No one has asked you about that today. Thats either good news, dont have to worry anymore or its other sign of the time that our Attention Span is too short. Can you just update us quickly on the status of Clinical Trials to test outsides on vaccines and therapeutics. Thank you very much for the question. It is good news. Good news in the sense that from a Public Health standpoint, the numbers of cases in west africa have diminished dramatically. Hasnt been a case in liberia in almost 40 days which means the country of liberia very likely will be declared ebolafree very soon. Liberia cases are down, begin any is still smoldering and you cannot claim victory until the last case is gone, and were not there yet. But from a research standpoint, there are a couple of trials that are going on now that were very pleased about. One is the therapeutic trial in which we have taken the most promising of the multiple experimental therapeutics against ebola and launched a randomized control trial involving centers that we actually have here in the United States and we had one of our own patients that we had recently released healthy following ebola was on that trial as well as in the west african countries. We now have 12 people on the trial. There were ten of them in sierra leone, one in liberia and one in the United States in addition the randomized control trial of the nih vaccine developed at the veep research center, together with a vaccine developed in collaboration with the canada yaps and an American Company has a matter of fact has been launched in february and we now have completed the early phase two trial of about 1500 individuals, good news is that it is safe, the safety studies we did in bethesda at the nih and still the spring, have proven to be the case in west africa. No adverse signals that would be caveats to stop the study but importantly, its inducing the kind of response that you would predict would be protected because it match the monkey response. Thats no guarantee its going to work but thats very strong indication that it is likely to work. The thing that is complicating it senator is that as were launching the trial good news is that the infections are going down. So it might be difficult to actually prove on an incident basis that the vaccine does actually work. But every indication that we have from the standpoint of the kind of response that its inducing suggests strongly it will work. Thank you. Thank you very much for that update and thank you for working on that. Senator cochran has no questions right now senator cassidy. I tell everybody that major Mental Illness is to drastically underaddressed in our society. That same article i reverenced earlier, 2011, it said that of those thing that were overfunded mentioning aids and a couple other conditions, that which was underfunded was depression as one example. So first if the criteria by which Going Forward theyll determine funding levels, includes the possibility for clinical advance im asking i dont know major Mental Illness is that something in which increased Research Dollars is there potential for that major advance that would help a child with psychiatrist schizophrenia with schizophrenia. I appreciate the question, senator, and theres no doubt that greater investment will give us better returns and this is an investment, not a cost at our end. I think to go back to your earlier question, i just think we need to frame this a little more broadly because one of the issue wes deal with particularly in thinking about schizophrenia or depression or bipopular illness bipolar we dont know about the basic can. When we leak Disease Burden is based on what we are spender only a particular disease. But you should understand that perhaps half of the budget goes into the fundamentals. I am so totally in agreement with you. One of my frustrations almost seems if were going to fun things which have been successful we almost are going to say are going to fund things we previously funned as opost officed to funding things we never had before bus well never get to the point where were successful. So that gives me an opportunity to push for the brain initiative
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