Transcripts For CSPAN3 NIH Officials Testify On FY 2018 Budget Request 20170627

Committee will come to order. The appropriations subcommittee on labor, health and human services, education and related agencies will come to order. Before my opening statement, i want to recognize melinda bikini, we had a chance to meet and talk about her cancer fight and the success shes made there when we were out in nih a few days ago, and we are glad youre here and i was just told that the youngest of your six children just got their drivers license so good luck with that. Good luck with all of that and we were glad to have a chance to meet with her, glad to have dr. Collins and the other Institute Directors here today. The budget, of course, proposes cuts that i think that you can rest assured the committee will find unacceptable. The 7. 5 billion cut from nih would according to analysts, this funding would cost nearly 90,000 jobs nationwide, result in 15. 3 billion of lost economic activity. In my home state of missouri that equates to a loss of nearly 1,700 jobs and 292 million in economic activity. The cut is one that i think you can rest assured this committee will not take. I certainly fundamentally disagree with the proposed funding reduction, however, this isnt the first president to propose a reduction. President obama proposed a 1 billion cut in his budget last year. We went 3 billion beyond his proposal. Im not sure we could do anything like that this year, but i also mentioned in a hearing earlier this week that when his budget was submitted to the senate, 98 senators voted against it and one senator voted for it. So we have a long history of the congress asserting itself on issues of how to allocate money. I believe this committee will do the same thing this year. In the last two years with significant encouragement from the whole committee and particularly from senator murray, senator alexander, senator durbin and the whole committee. We had nine of our committee out at nih recently. It was the Biggest Senate delegation to ever go to nih. We spent most of the afternoon i hope you dr. Collins and your Institute Directors know how much your work is appreciated. In the last two years weve increased nih funding by a little more than 13 and were going to be listening carefully to your presentations today but before that id like to turn to senator murray for her opening comments. Thank you, very much mr. Chairman. Thank you dr. Collins to you and to all of your team for being here. We appreciate all that you do to championing the critical work of nih. Youve been a great partner and appreciate your leadership and i too welcome ms. Bakini. Its good to see you again. And i look forward to having a discussion today about really the devastating impact that President Trumps budget would have on nih. As you all know President Trump has proposed cutting nih by 22 , most of it by arbitrarily capping indirect costs resulting in the lowest funding level for Biomedical Research since 2002. Three months after releasing this proposal we still do not have basic information from the administration about how nih would implement a 7. 5 billion reduction. Without severe consequences for thousands of Research Facilities and tens of thousands of scientists that rely on its grants to support their work. Facilities like Fred Hutchinson institute in my home state of washington just to cite one example where scientists have pioneered bone marrow transplants and searching for cures to cancer and hiv vaccines. But because of this proposal, could be forced to dramatically scale back their efforts to develop cures for patients. These cuts are deeply concerning which is why i said repeatedly, i really hope that both parties will once again reject President Trumps Budget Proposal and continue to Work Together as we have to ensure nih is able to carry out its vital work and booster Economic Growth and competitiveness. Before this discussion can happen i have to note that todays hearing take place in the very midst of Pivotal Moment for our Health Care System as a whole. As we have heard all week our republican colleagues appear to be dead set on jamming their version of trumpcare through the senate in just a matter of days. This is a bill that has been subject to no hearings, no public debate and no expert testimony. Its a bill so secret that apparently until just moments ago, many republicans senators were telling press and constituents they couldnt say what was in the bill. It was a bill so secret even President Trumps Top Health Care advisor, secretary of human and Health Services told us last week that he didnt know what was in it. It has been so seek create and seek credit and closely guarded that not even the 13 male senators who made up the socalled working group could comment on certainly on what was in there or when it would be brought up or by what procedure. And, in fact, its a bill so secret that even the White House Press secretary couldnt confirm whether President Trump or anybody in the white house, for that matter, had seen the bill. Which begs the question, as i have said this week, what are Republican Leaders so ashamed of . It is becoming very clear now that those who wrote the Trumpcare Bill knew they wouldnt be able to go back home and defend it because based on what we are now learning this bill is going to be the same kind of Trumpcare Bill that went in the house and it will have tremendous impact on patients and families. Higher costs for families especially seniors and people with preexisting conditions, Insurance Companies no longer will be required to cover basic health care, like Maternity Care or mental Health Services and more. Women would lose access to their doctors and to the care they need at planned parenthood and tens of millions of people across the country would see their medicaid coverage taken away. That means people nationwide who are finally getting treatment for Substance Use disorders like opioid addiction or Mental Health care or access to a primary care doctor under medicaid are going to lose that access. So as many of my democratic colleagues have said, this is not a health care bill. Its an attack on Families Health and financial security. Again i just want to reiterate my message to Republican Leadership, it is not too late to dump this Trumpcare Bill. Its not too late to make the right choices and work with us as democrats to fix our Health Care System. As the chairman and others on this committee should know by now, democrats stand ready. As we always have to Work Together to actually make health care more affordable and accessible for patients and families across the country. But we cannot begin that conversation until Republican Leadership reverses course. And lastly, i do have to say that after hearing this week about so many of my republican colleagues feeling frustrated about this bills process who are angered about being shut out are receiving conflicting information or who may be even shocked at the text that was just released, you have the power to do something about it, not just to complain. You can insist on full hearings, open debate, increased transparency, because lets be very clear, people across the country are really worried about the approach thats being taken. Theyre watching. Theyre going to be paying close attention and we need to get this right, not what is being jammed through the senate and with that mr. Chairman, ill turn it back to you. Thank you, senator murray. Were pleased to have the chairman of the full committee and Ranking Member of the full committee with us today. Chairman cochran does not have a statement but i think you do, mr. Leahy. I ask that a statement be printed in the record. Thank you. Thank you, chairman blunt, chairman cochran, glad to be here with you and of course with senator murray and i completely agree with her statement. I think this is an important meeting, dr. Collins. Good to have you here and your whole team. Just for a personal note, when my mother, when she was still with us she was first generation Italian American and when she saw my schedule she thought you say hello to that nice young man. Or she said bonjourno. I am worried about the budget. This affects all of us. You have to support the middle class, you have to lift up the most vulnerable. You have to serve our values and interests as a nation and nih has been a shining example of serving our nation, but sequestration has had devastating consequences for both defense and nondefense programs. I think those consequences are going to last for a generation, theyre going to affect my children and grandchildren and this budget makes it even worse. The budget cuts, those have drawn the most bipartisan opposition and you heard what the senator blunt said and others have about this budgets. The most bipartisan criticism has been the reductions for the National Institutes of health and i have want to commend chairman blunt and Ranking Member murray for their efforts to bolster the nih budget in recent years, but this one, this budget that weve been given by the white house turns that progress upside down, it slashes nih resources by 7. 2 billion, 21 , lowest nih budget since 2002. You know far better than i do, you cant medical research you cant say well just turn off for a few years those studies and trials and all, but well come back five years from now and pick it back up again. You just cant do it. You dont hit pause on studies. You cant have ups and downs based on the whims of an antiscience group. That hurts the medical search field. I think not only would it do to you, a cap on research around the nation, universities and other entities. Im not being parochial but i mentioned the university of vermont. They received millions of dollars of nih grants each year. They enrolled recently to wrote recently to director mulvaney and secretary price and noted its unlikely they could continue their research on this budget, and theyve been doing cuttingedge research in cancer, among other things. And id ask for full copy of the university of vermonts letter be placed in the record, mr. Chairman. Without objection. Thank you. So i think as vice chairman of the Overall Committee im committed to getting money back in. This science, this is where we can excel. Where we can lead the world. But not only that, we can make life so much better for our own people and people around the world. So i will fight for every dollar that i can and thank you very much, mr. Chairman. Thank you, senator leahy. Director collins, were pleased youre here and look forward to your Opening Statements and when youre through with that well go to questions. Let me introduce the folks at the panel table with me. Over on my left, your right, dr. Richard hodus the director of the National Institute on aging, next to him dr. Vol could have on drug abuse, next to me doug lowie whose the acting director of National Cancer institute, joshua gordon, and youve already recognized in one comment at least dr. Tony faucci. The director of the National Institute of allergy and Infectious Diseases. And at the far left on your side, gary gibbons who is the director of the national heart, lung and blood institute. We brought the ateam today so its a pleasure and an honor that we were able to host many of you on our campus earlier this month and its a great honor to be here with you today and im privileged to continue in that role as nih director. I want to thank all of you for your sustained commitment to nih, a commitment that will ensure that our nation remains the Global Leader in Biomedical Research with all that means for human health. Today id like to highlight several areas of exceptional scientific opportunity. Introduce you to a few patients and also talk about some young searchers who are working hard to make these dreams come true and ill show a few images over there on the screen. Lets start with an opportunity that shows the transformational power of investing in nih basic science. Imagine that you could determine the price molecular targeted by pharmaceuticals and see how they interact with each drug. This is starting to happen. Thanks to a new technology called cryoem. This image caused the structure of a promean channel that regulates salt and water balance in the lungs. This very protein is misfolded in Cystic Fibrosis, our nations most common fatal genetic disease. The genetic mutation was discovered in my own research lab many years ago, but only now is new structural information allowing us to design better drugs to help Cystic Fibrosis patients like little abalynn mahoney, who will be celebrating her 2nd birthday next week. Her life has not been easy. Shes required surgery. For an intestinal blockage shortly after birth. Shes doing pretty well now. Just a few decades ago she probably wouldnt have made it beyond her teens. No longer. Today we have two targeted drugs for cf and more to come all building on nihsupported basic research. Were not done. The goal is to turn cf into a 100 curable disease. For that we need the next generation of scientific talent. Among the early stage investigators tackling this challenge is steven allor of the university of alabama at birmingham. Trained in both Computer Science and biology, steven plans to transform in fundamental ways how we design and deliver drugs for all kinds of conditions. In fact, we need that. Treatments only exist today for about 500 of the 7,000 diseases for which a molecular cause is now known. Among those in desperate need of of a breakthrough is Sickle Cell Disease, a lifethreatening disorder in which red blood cells are deformed in a way that clogs small blood vessels. Sickle cell disease is caused by a genetic misspelling. And that was essentially understood 60 years ago, yet even today the only way it can be cured is by a bone mary transplant from an unaffected donor. That can work really well for some patients like chris sweet shown here with his family. Chris received a transplant at the Nih Clinical Center six years ago and is now essentially cured. But unfortunately, most dont have a wellmatched bone marrow donor. What if we could correct that sickle misspelling in the patients own blood cells . A few years ago i wouldve said thats pretty unlikely but thats all changing. Nihs Courtney Fitzhugh is seeking to use a new gene editing system called crisper to modify bone marrow cells in Sickle Cell Disease. The goal is to fix the underlying genetic defect and make the persons own cells healthy. If courtney and other young scientists can get this to work for Sickle Cell Disease, just think about what they might do for thousands of others still await ac cure. Imagine you could get a detailed understanding of the 86 billion neurons in the human brain. Thats what our Brain Initiative aims to do. I know that each member of this subcommittee is aware of the enormous toll that Brain Disorders are taking upon our Nations Health and economy. Alzheimers disease alone has an estimated Economic Cost of 259 billion this year and is projected to exceed 1. 1 trillion by 2050. Lets imagine that using tools and technologies created by the Brain Initiative you could easily identify someone at risk for alzheimers and use such advance warning to apply effective ways of preventing this disease thats touched so many. Including singer Glen Campbell who was on the hill with his family a few years ago to advocate for alzheimers disease research. Young investigator rose of Massachusetts General Hospital is among those taking on this challenge. Her work is focused on the largestknown group of people in the world with inherited alzheimers. An extended Family Living in the mountains of colombia. In the effort to capture subtle changes in the brain, her team is using p. E. T. Scans to compare the brains of family members who carry the alzheimers gene mutation with those who do not. Clearly, fighting alzheimers wont be easy but rose and other young researchers have the talent and drive to make it happen. And you all are part of this. Your emphasis on alzheimers and related Dementia Research in fiscal 2016 and 2017 is enabling progress toward our mutual goal of preventing and effectively treating these devastating conditions. All of us here are motivated today by a sense of urgency to help patients in need of breakthroughs. The next generation of innovative and passionate young researchers will be the critical part of achieving that bright future. Two weeks ago nih announced the next initiative a focused approach to bolster support to early and midcareer investigators like the three you see here. Our Nations Health and wellbeing depend on your strong support for them. So thank you, mr. Chairman, my colleagues and i welcome your questions. Dr. Collins, again, were glad youre here. I was pleased with the president s decision to continue your leadership at nih and many of us that advocated for that and were pleased to see it happen. Your team and what your team does is inspiring to all of us. Well have a five minute round of questions. I think there are a lot of competing things going on today so well try to keep that as close to five minutes as we can starting with me. A couple of areas i want to ask specifically about in the president s proposal, one was to eliminate the Fogarty International center, i think particularly with the zika process were going through and have gone through that center was pretty actively involved and your thoughts may be about what the center does as opposed to commenting on necessarily the president s view of this. Appreciate the question. Ill ask dr. Faucci to Say Something about this. The Fogarty International center is truly integral to all that we do, both directly and indirectly, internationally and domestically because particularly in the arena of Infectious Diseases as we know and have testified before this committee so often, that Infectious Diseases know no borders. Some examples of how the training of International Scientific colleagues has benefited the United States of america and the two that is in most recent memory are the Ebola Outbreak and zika outbreak not to mention the longstanding commitment for hiv and aids that are being done in africa, almost all of whom these trials are led by International Scientist who were trained by fogarty grants. With regard to ebola, you might be recall that in west africa in liberia and sierra leone they had 28,000 case and 11,000 deaths. If that had gone beyond those borders to places like mali or nigeria it could have been a greater catastrophe and when infected individuals actually went to mali and went to nigeria, it didnt make much press, because it was a success. But the investigators in those countries were able to handle, identify, isolate, Contact Trace and stop it in those countries before it started particularly in nigeria which is the most populus country in africa. Each of those individuals were people who were trained at the Fogarty International center. We look upon them as our true colleagues. I referred to them and i mean that sincerely as our brothers and sisters in the battle against infectious disease. If this were a metaphor of a military thing, they would be our closest allies. They wear maybe a different uniform but they are our allies. The impact of the training has been extraordinary and we really need to continue. Another area, the establishment of the National Institute for research on safety and quality do that, the agency for Health Care Research and quality would be consolidated into a new i believe they propose a new institute in your organization. One, if you want to comment on that generally, and two, if that was going to happen, are there alternative ways for those things to be moved into nih without creating a new institute . So the agency for health Research Quality does Complementary Research to nih particularly focused on Health Safety and health quality. For instance, looking how to prevent Health Problems such as hospital readmissions, such as infections from extra zones catheters. We have strong interest in the work they do and have close correction connections with them. We regularly look at our portfolios to make sure were being complementary and not duplicative. If it was the case nihq was moved into nhi as proposed in the president s budget, we would figure out how it is that we could make the best of that circumstance in order to keep that Important Research going forward. Your other question is would there be other models to achieve this other than a new institute . Certainly, we could consider other models such as having the portfolio thats part of the arhq distributed around who do Similar Research and incorporating the staff thats part of ahrq into the nih staff without having them to set up a separate entity. That would be another option. I might point out in my last 30 seconds here to something i shouldve mentioned earlier and follows up on senator murrays view. What weve done at nih in the last two years there was no new money to do that so it was truly a prioritization that eliminated programs and consolidated programs and these were programs we had to determine werent doing everything wed hope they would do so that priority could be placed on what youre doing and this is one of those times when Congress Really has chosen to make decisions that for a lot of members were really hard and some members were almost impossible to make but the case youre making is an important case for us to be able to understand and talk about. Senator murray. Thank you, again dr. Collins to you and all your team. As you have been hearing there is tremendous concern among the Research Community about President Trumps proposal to cap indirect costs. What can you tell us about the status of efforts to release the existing longstanding practice for calculating indirect cost with a 10 flat fee . Are your staff participating in those discussions . So indirect costs may be say somewhat unfortunate term because its hard to know whats being referred to and another alternative is f a. Those indirect costs are about 28 of the grant awards and the extra community but it varies from institution to institution. It covers such things as the facilities, the building, the United States, the supply of light and water. The operations of various Administrative Services such as human subjects oversight, animal care oversight and so on. Those are not things that can be ascribed to a single grant but theyre necessary for the institution to be able to conduct research. Certainly the proposal to reduce the amount that would go from nih to indirect costs from 28 roughly on the average to 10 has attracted a lot of attention in the community, because universities who do this work see that as potentially quite dangerous for their ability to keep going forward. We are looking at every possible way that we might be able to assist in this conversation by identifying areas in which various Administrative Burdens that we ask institutions to follow could be reduced because maybe theyre not as necessary as others. Were looking at our current regulations, for instance about conflict of interest, about animal care about effort reporting. We might in that process be able to identify a way to reduce somewhat the burden. But frankly, i dont think it would add up to an norm miscellaneous difference in what were currently asking our grantee institutions to do. And they are the ones who do the work. We depend on them. What would happen to your Intramural Research program if the costs were capped at 10 . Our program which you visited recently, much it on the nih campus is about 11 of the overall budget. Calculating indirect cost is a little complicated. Its a purely government facility. When that was recently looked at but not that recently, it was about 30 . It was similar to what we see happening in the extramural community. For that intermural program, there would be no other potential source of funds. It would make it rather hard for me or anyone at this table to imagine what we would do if that was required to drop to 10 given that we have the buildings and the electric power and so on. It would be pretty devastating . Im having a hard time imagining how we would manage that. Dr. Louis, this proposal assumes that states or some other benl factor would step in and cover the lions share of costs once nih abandons that responsibility. Its a lot to assume our states would pick up whats long been a federal responsibility. But a lot of private institutions dont have access to state resources or large trust funds that could cover the difference. What would likely happen to those research places like fred hutch or scripps, if theyre forced to reduce their indirect costs to 10 of their grant . Senator murray, its difficult to speculate exactly what would happen. But institutions such as the Fred Hutchison Cancer Research center have been central to the advances that we have made in Cancer Research. For example, donelle thomas received the nobel prize for the research that he conducted with his colleagues at the Fred Hutchison. More recently, paul wynn led the effort to do research on use of immunotherapy for patients with merkel cell cancer and this has led to a breakthrough for those who have this disease. Its not as common as melanoma but it is the skin cancer that has the highest mortality rate and recently the fda approved a cancer immune checkpoint inhibiter for treatment of this disease, the first advance in many years at the Scripts Institute for example, theyre performing a Breakthrough Research on trying to inhibit a particular gene called mic that is involved in at least 50 of human cancer but we dont yet have interventions that are successful for that. So these are just some examples of the breakthrough treatments that are being developed at these institutions. That would have an impact if the direct impact was cut, it would be hard for them to continue that . Yes. Certainly they would have difficulty to continue their rate of progress. Okay. Thank you very much. Thank you, senator murray. Chairman cochran. Mr. Chairman, let me join you in congratulating our panel here in the participation youre bringing to this challenge. Dr. Collins, how is the nih working to ensure that minorities are represented at Alzheimers Research activities . So we are very interested in making sure that the resources Congress Gives us are utilized in an optimum way for Health Disparities Research Across all the fields represented by people at this table. You specifically asked about alzheimers. Im going to ask dr. Hodus whos our key person for Alzheimers Research to address that. Thank you very much for the question. In fact in our efforts in Alzheimers Research, very prominent among them is attention to disparities. Both because all americans have a right to the fruits of research but also the best understanding of what underlies the processes of alzheimers is going to come by understanding how it affects individuals of different racial, ethnic, and social backgrounds. A great deal of discovery has shown that genetic risk factors differ across groups. To ensure that we include these populations in research, we have active recruitment efforts that are broad. We work through collaboration with some of the existing resources. For example, some of the populations who have been studied through nhlbi, including those in your own state, are being harmonized with other studies that we can look across all of these, do comparisons about risk factors, causes, and ultimately identify interventions that will target on a personalized basis across disparry populations. Thank you. Thank you, chairman. Senator durbin. Let me first acknowledge dr. Lowie. Thank you for coming to chicago last october and meeting with the directors of illinois designated comprehensive cancer senators. Comprehensive Cancer Center of northwestern and university of chicago medicine comprehensive Cancer Center and thanks for your years of service as the acting director of the nci i understand youll be stepping aside to allow Ned Sharpless to take over. Your work personally has helped to develop a vaccine against cervical cancer. Which is a leading cause of cancer death among women. It has saved and will continue to save countless lives. Our nation and beyond are forever endebted to you for your dedication to research. I hope reports that you are going to continue on at nih are true. I just want to thank you on behalf of this committee and the people who have been benefited by your great work over the years. Thank you dr. Lowie. Thank you, senator durbin. Let me ask you a question, dr. Collins. If i were to ask you whether or not nih research was part of the development of a certain pharmaceutical drug or part of the development of a certain medical device, could you trace the lineage of the research so you could tell me a yes or no if nih was involved . I think usually we could and in about 75 or so the questions of that sort you would ask the answer would be yes, nih played a role, not necessarily a direct proximal role to the ultimate product, but discoveries that happened at an earlier point leading to ideas about mechanisms, leading to ideas about possible therapeutics. Yeah you can connect those dots and those dots almost always involve nih research in some way. Well, let me tell you why i ask you that question. Were all sitting here wearing clothing and suits and such and some where theres a label inside where its made. And we go out to the market and we buy products and we have an identity of the producer and contents. And i think its about time that the nih had a label that is applied to pharmaceuticals and medical devices and other things where you can connect the dots. I think its time the American People came to hear of the National Institutes of health being referred to on a regular basis as part of the sourcing of the great things that are happening. You have so many miraculous stories to tell. And i dont know if you did a survey across america how many people would be able to identify what the letters nih stand for. I think its time we do something about it. We pass laws about the labels in my suit and the labels on products, and id like to ask the chairman and others to think about joining me in a bipartisan effort to make sure that credit is given where its due so that americans come to appreciate how you are at the heart of basic research that really makes their lives an awful lot better. Im going to work on something and work with you to make sure we do it in the right way. Senator, i really appreciate your emphasizing the importance of this being more widely recognized. It is true if you ask people on the streets do you know what nih is, i think the last survey, it was less than 20 . Much higher recognition for nasa than there is for nih and yet obviously a lot of the taxpayers dollars going into what were trying to do here. I would give a quick plug that in august there is a series on discovery called first in human which follows a series of families that have been treated at the Nih Clinical Center which you all just visited a couple of weeks ago. It is powerful. It is three subsequent weeks, twohour segments. And you will follow and see what happens to these patients and these families as they go through what are clearly circumstances that are quite desperate, and thats how people come to us, because all other options have been ruled out. That would be a very good way for america to get a sense about what we do and why it matters so much. Thank you. Dr. Volkoff, we are in the midst of an opioid heroin crisis. Some places hit harder than others including the home state of my colleague, senator shaheen. It is an incredible crisis generated by the production of 14 billion opioid tablets a year in the United States of america. Enough for every adult, every adult to have a onemonth prescription to opioids. That production number is approved by the federal government each year. The department of Drug Enforcement administration. And then, of course, it gets into the general population by scrips written by doctors. Cdc has warned these doctors, dont overdo it except in extreme cases. I know youre looking closely at this but would you comment on the fact that at least at this moment the United States government is complicit in the overproduction of opioids . Well, i think that in the Health Care System we have to recognize our involvement in creating the opioid crisis. It was a result of a wellintentioned initiative to treat those patients that were suffering from chronic pain. But without the proper education or understanding about the tools that were using to actually treat those patients, which was predominantly relying on opioid medications. And as a result of that, there was an overprescription that were currently living. That led to diversion of use and then transfer into heroin and synthetic opioids. What were doing from the nih perspective is taking a multipronged approach to address it. Recognizing that the needle need of patients was initial driver, we are aiming to actually create publicprivate relationships, a partnerships, and this is encompassed by the nih, for energizing the development of products that are not going to be addictive. Thats one of them. The other one is again incentivizing the pharmaceutical through this Public Private partnerships to the development of alternative relations for the medication that we currently have for treating opioid use disorders as well as to developing alternative targets for the treatment of addiction of opioids. And finally, again, through Publicprivate Partnership with industry, to develop prevention interventions for overdose as well as to develop even more efficient reversal medications such as narcan to address the opioid crisis. Thank you. Thank you, senator durbin. Senator moran. Chairman, thank you very much. Dr. Collins, welcome to you and your fellow directors at nih. Its a pleasure to hear from you. I join my colleagues in expressing the gratitude of the work that occurs at nih and across the country, on behalf of improving the lives and the wellbeing of millions of americans and people around the globe, especially helping us while we have this Health Care Debate going on its always been my belief if we can develop resources into finding cures and delays and treatments of diseases, its one of the suggestions ive made for a long time, we can do a significant benefit to the cost of health care in the United States. And as we have a debate going on about how to pay for health care, i hope we never forget the opportunity to look at why Health Care Costs so much in the first place. Who pays is a different question, thats a challenge for a lot of folks. I hope we can spend a lot of attention on that. Including the continued support for nih and its mission. Let me ask a process question, i guess to dr. Collins. One of the things that has been brought to my attention is the way that nih spending occurs in grant support. And i raise this with secretary price when he was in front of our Committee Last week. But its my understanding that some Research Institutions make, and particularly universities, make the salaries of their researchers contingent upon receiving an nih grant. And instances in which some researchers receive up to 80 of their salaries as a result of a grant. And the question i raise is, is there thought about trying to focus the nih grant dollars on the research as compared to the salaries of the researchers . Such that more money goes into i know you cant have Research Without the scientists. But i also know that universities and other institutions, in my view, should be supporting those individuals more, where grant dollars go to the research. Am i missing something, dr. Collins . No i think youve accurately stated the facts of the situation. Since world war ii, the government through nih and other funding agencies for science has sought to try to encourage institutions to do Scientific Research and has basically then contracted with those universitys to provide the full cost of that research being done. And that has included in that calculation then the percentage of time of a faculty member thats going towards a Research Project as an allowable request when the Grant Application is submitted. And many of the times in some places where faculty are essentially doing almost all of their work in research, the effort over various grants can climb up to be in the neighborhood of 50 , 60 , even 80 . Although in reality on the average its generally much less than that because most researchers have other activities as well. Again, we do not pay for other activities of faculty such as teaching or running committees for their institutions. It looks as if roughly something between 5 and 10 of the nih budget currently goes to pay the salaries for those faculty members who are our grantees who are doing that research. Institutions would obviously be alarmed at the idea that that would no longer be allowable. I would point out that there are caps on the level of salary that we will pay. A salary cap has been applied by the congress in most of the last many years. But in terms of an actual effort to reduce the total percentage, that has not previously been tried. I would also say, of course, that we are willing to pay the salaries of the postdoctoral fellows, the technicians who are working in projects and some of those would be at 100 level because thats all theyre doing is doing the research. If you add up all the salary coverage, well, its probably in the neighborhood of 35 to 40 of our grant extramural funding. But in a way thats our most critical resource. Those are the people doing the work. Theyre the ones we have the hopes and dreams are going to make that next discovery. So again, hearkening back to the arrangement made after world war ii, this has seemed so far consistent. Thank you for your answer. I may explore with you additional thoughts i have on this topic outside the hearing. Happy. Let me ask dr. Gordon. I chair the subcommittee that funds the department of veterans affairs. Its a new assignment to me in the aproceedings process. Whats the relationship i mean, and one of the things i think in which the va faces some of its greatest challenges is in the care and treatment for those who served in our military and the consequential effects upon their Mental Health. Too many veterans slip through the cracks and often its, in my view, its in the Mental Health arena. What is it that takes place in research at the department of veterans afairs that is different or in addition, how is there coordination between what happens at the nih and the va . Thank you very much for the question, senator moran. We have at the nih, like the nih in general, a longstanding collaboration with colleagues at the va. Many of our investigators work with the va investigators, many va investigators work with us. Specific programs, we focused on over at recent times include programs in Suicide Prevention and in ptsd research. Suicide prevention, we played an integral part in helping the va develop research to identify those veterans who are at highest risk of suicide. So that we can help them get into treatment and reduce the suicide rates among veterans. Thats an Ongoing Program now thats being implemented throughout the Veterans Administration that will hopefully help save lives in the near future. We also are engaged in research programs, as i mentioned, particularly around ptsd, but in general around the Mental Health of veterans. One resource that the Veterans Administration has constructed, the million veterans program, is an area of active interest which were engaged with them in trying to help our extramural investigators that we fund to use that data to better the health of veterans and really all americans. Thank you, doctor. Thank you, mr. Chairman. Thank you, senator moran. Senator shaheen. Thank you, mr. Chairman. And dr. Collins, thank you very much for hosting the members of the committee who came to nih two weeks ago. And thank you to chairman blunt for arranging that visit. I certainly learned a lot. It was very impressive to see your work firsthand at nih and we appreciate everything that you all do. Dr. Volkoff, thank you for coming to New Hampshire and for seeing the challenge that we face with the heroin and opioid epidemic. You joined me at Catholic Medical Center and we heard a very compelling presentation about how they were dealing with seven patients all in with an overdose of carfentanyl in the emergency room and what challenges that presented. Certainly as we look at whats happening in New Hampshire, we have got to do more, weve got to provide more resources, more help. I know you responded to senator durbin about some of the things that youre working on. But is there something that you think holds the most promise that we ought to be focused on . Or is this trying to better coordinate everything that were doing . I mean, we need to in order the solve the crisis, we need an integrated approach working with other agencies and multiple strategies. Ed so one that i was describing was specifically targeted towards development of medications. But in the meantime, we need to actually act rapidly. And one of the big challenges, particularly certainly in New Hampshire, but not unique to New Hampshire, is the lack of treatment programs that can accommodate for patients with substance accommodate with patients with Substance Use disorders. So one of our priorities has been to take advantage of the fact that there are healthier systems throughout the United States. So how do we integrate the healthier systems to be actively involved in the screening, treatment for patients with the disorder . So we were looking to Emergency Departments for treatment, and as many of these models that are starting to emerge in the states like new mexico, and were trying to evaluate them so we can translate them into other places. So these areas for opioid research, new models for treatment is fundamental. Absolutely. And ive visited many hospitals in new mexico. And one of the things everyone cites thats been critical to how to respond is medicaid and how to get medicaid dollars. And weve Mental Health hospitals, Community Centers that are looking to expand treatment because theyre going to count on those medicaid dollars that are available through the Affordable Care act. So as we look at what happens with health care here, thats one the real challenges i think we face. I want to go, and im not sure, dr. Collins, who to direct this to but one of the real chronic diseases that were challenged with in this country is diabetes. I have both a personal and policy interest in type 1 diabetes. And i think there are many people in the country who dont understand theres a difference between type 1 and type 2 diabetes. Type 1 has nothing to do with lifestyle, nothing to do with how youve eaten, nothing to do with where you live, sadly. Buts it also is increasingly at rates that will make it hard in the future to afford treatment to make sure we can address this disease. I think the statistic is by 2050 one in three americans will have diabetes, either type 1 or type 2. So can you talk about what research is happening at nih to address diabetes, both type 1 and type 2 . Id be happy to do that. Because my primary research is focused on type 2 diabetes. For type 2, the type thats generally coming on later in life but not so much anymore with problems with child obesity, thats pointing us in the rig for type 1 diabetes, again, were learning more about the genetic susceptibility. We still dont know quiet know what the environmental trigger is. And we know there must be one because not everyone with type 1 gets the disease. It would make it possible for kids and adults with diabetes to have a way of managing their glucose and insulin without having these freak wpt finger sticks and injections of insulin, which frankly, dont work as nicely as one would like. Just last year when i spoke to this panel, i predicted we might find in the next ten years a prediction of it actually happened about six months later. I was going to say its going to happen a lot sooner than ten years. There you go. Ultimately we believe this kind of artificial pancreas could be even better if it was made not from this kind of machinery from from your own cells, to take your skin cells and turn them into those cells that make insulin that maybe arent doing that anymore for someone with type 2 diabetes but could be convinced to do so. Its a very exciting area. Thank you. And thank you for the work youre doing. Senator moran and i might have a second, third, and fourth round of questions while youre all here. And wed be fortunate to have that. Dr. Lloyd, in march we had a hearing on funding and cancer. One of our witnesses, dr. Tim runs the Cancer Center in st. Louis. And he was talking about the importance of precision, medicine. One of the things he thought might be possible to determine was whether 80 of the women who currently have chemotherapy after Breast Cancer surgery would have to have that. I think theres some active discussion that probably only about two out of ten women benefit from that, but how to define that. But on that topic and generally your immunotherapy advances, would you talk a little bit about individual cancers and individual people and how they fight those cancers . Youre working to find ways to find what treatment they need and also ways to figure out how they can better from theyre own unique make up, fight that cancer. Thank you, senator. I had the pleasure of visiting dr. Everline. And many are at the forefront of this precision medicine. The overall goal as you point out is to deliver the right medication for the right patient at the right time and not to overtreat people because we know that overtreatment can sometimes actually have serious side effects. Recently, for example, with fci supported research it was reported at the asco meeting, giving people less treatment actually did better than people with more treatment. We have been conducting research that is trying to understand better how the molecular abnormalities with Breast Cancer and other kinds of cancers can have implications for what treatments should different patients be obtaining as we try progressively to refine those opportunities and those interventions. Dr. Gibbons, i think theres some new research out that would suggest that having a stroke more than doubles the risk of dementia. Could you talk about that a little bit. And also in that area, you might further define as people get older, a stroke may not even be apparent but i guess my question is stroke as it relates to dementia. Sure. Its an important question you bring out, senator, in which we now appreciate theres many forms and pathways that promote dementia. You all are very familiar with alzheimers, but theres also another category thats called vascular dementia that can affect one in five individuals with dementia. And it may be cumulative effects of vascular disease over time that leads to cognitive decline promoted by risk factors such as high Blood Pressure and other risk factors of not only Heart Disease but compromises brain health. It is actually one area where women appear to be particularly predisposed as far as the cause of dementia as well as africanamericans. And again it relates to a question by senator cochran as to why in the jackson heart study, were particularly interested in looking the causes of dementia in africanamericans, may give us some particular insights in that regard. We also have collaboration are engaged in the sprint trial in which were looking at the affect of lowering Blood Pressure in terms of pruving cognitive function. So this is an active area of research. , you know, i would think also thats another verification of generally my view and i think the committees view that while prescribing funding in some areas is frankly helpful to get these funds increased and to make the case as in alzheimers weve gone from, i think, 400 million to 1. 3 billion in two years. But one, youre better at knowing where the pathways are than we are. And two, theres more than an even chance i believe that youll find something somewhere differently than youre looking for. And theres lots of research that suggests thats the case. Senator moran. Chairman, thank you. Perhaps this is for dr. Hoteus. What is the current state one of the things i think and ive told chairman blunt this and were in agreement one of the opportunities this subcommittee has is to highlight to americans ways they can change their life stile, dietary intake. Whats the status of the research in regard to dementia and alzheimers today wed want every american to know in regard to their activities, behavior, nutrition, and diet . Thats a very important question. Obviously, all of us both individually and in society want to make sure were doing all we can to decrease the risk of cognitive decline. They did a study just on this to ask what the intervention is that might reduce risk. I think your staff may have been briefed just as aurally as yesterday about it. The key words is theres encouraging in most cases, and inclusive evidence for what we can do. One just alluded to is control of hypertension. So theres very Strong Association between hypertension, control, and the risk of alzheimers disease and dementia. As dr. Gibbons mentioned, one study, sprint, was designed to look at progression, multiple outcomes. And working together using the alzheimers funding, have looked at the impact to study dementia. So its an area of great promise where Clinical Trials may give us conclusive evidence. The importance is so critical it must be a part of our Public Health imperatives as we chukt. Another area is that of physical activity and exercise once again to decrease the risk of death, card yo vascular disease. And again, theres suggestive evidence it may be play a role in decreasing the risk of dementia. There are a number of studies that are looking directly in randomized Clinical Trials to see what forms of physical activity may make a difference in lowering the risk of cognitive decline and dementia. One study supported by nih years ago showed that cognitive training was actually able to induce sustained improvements in cognitive function of particular areas as individuals aged. That kind of study needs to be extended further to see if itll actually have an impact on dementia. Whats the example of cognitive training . There was a specific study called active, as its acronym, they looked at older americans, men and women, who had cognitive function and then trained them in speed and memary and then studied them over the year. And it was an extremely positive outcome. Those individuals trained in those areas did have improved function five and ten years in that domain. There is not yet compelling evidence for any of the other activities including the computer driven games to identify whether they provide similar outcomes. So there are a good number of studies currently supported in another area were able to look to see what kind of cognitive intervention as well as others may plia role. Thank you in response to senator durbins suggestion that the nih should have a shot to receive more credit for its work. One of the ways americans should relate to nih is heres one of the things that you do, if youre maintained, theres a consequence to thisavr. And it is a way that i think you can tie nih to americans and their lives. Their worried about themselves and their families. Let me tie in another topic i care about, down syndrome. Wave had a topic of which syndrome and alzheimers, perhaps theres a connection. Whats the status of our research in down syndrome . I dont know who i should be looking at. Ill keep looking to my right. Whats the status of that ruch and what should we know about the relationship . Well, its a very Important Research that probably begins on a genetic basis. As you know, done syndrome is a genetic disorder, probably on gene 21. Its a remarkable accomplishment, over 30 years now on average life expensancy not 30, but 50 or 60 are developing higher life extentancies. So both because this population now is now one of the special high risks deserving of attention and by studying this population is likely to inform all we know about Alzheimers Research, we have a child collaborating with the health institute, and again using the funding thats been provided over the last 50 years initiated longitudinal studies in individuals with down syndrome toy whats happening in the brain with individual markers to understand the basis for multiimately intervening in these people swelds learning about the more general problems surrounding alzheimers and dementia. Thank you all. Thank you for speaking in language and terms that are recently understandable to me. Thank you, senator. Senator alexander. Thank you, mr. Chairman. First of all, let me thank you for what you do for our country. And were all excited for the future of the National Institutes of hope, as dr. Collins calls it. Were excited the institute asked dr. Collins to lead that. And we look forward to your implementation of the 21st cures act that we voted for and in fact ask nih what could we put it in there make sure you succeed . And i want to absolute senator cochran, senator durbin, senator moran for their increasing department in research. Theres little that has epihappened in terms of our technological Research Since world war ii that we havent were obviously leading the world and not slowed down. Dr. Cochran would i be correct in saying its a goal of the Trump Administration to keep leading research . Yes, thats my understanding. Is it true around those and we spend a lot of money on them. The office of science supports 5. 3 billion in the laboratories, thats in the Energy Department 28 billion goes through your agency for research. Is it true around these universities like the university of kansas, tennessee, missouri, grow complexes of industries who are attracted by the research and who as a result create jobs around these centers of research . Thats absolutely true. If you look at the geography of where those places have sprung up, its very oftentimes attached to those attached to those ideas and Critical Mass visionary scientists. Is it also true china is making extraordinary investment in Research Even though they have one fourth of our gross domestic product. And a result of a number of our scholars at universities are being attracted back home the. Thats also true. Recent paper it pointed out that in 2000 china spent about 12 on what the u. S. Spent and then by 2015 it was 5 . This leaves me to more n one of the more harebrained ideas in the budget that we lower the amount of indirect costs thats allowable for Research Grants from 28 to 10 . This came up when i was education secretary ten years ago, produced a huge up roar. Most universities and colleges said to us at the time time, look, we spend a lot more than the average 28 on research. And the net effect from taking that to 28 to 10 would be Less Research. And less ruch means more jobs moving overseas to get close to research wruv it is in the world. And just did a quick look. University of tennessee could lose 10 million if that went into place, kansas, 4 million. Well, tennessee, missouri, kansas, might not be. The only way i can think of to make that money up is either high higher tuition or Less Research. But Less Research to me means more jobs overseas. I understand you may be asked because of the 28 billion that goes to your agency for the universities were trying to increase, not decrease, to report to secretary price and to office of management and budget which i have great suspicions that this originate there. What the effect may be so may i ask you put in your report the following. Number one, if this Congress Wants to be involved, and ill in the middle of that and make sure we get a Bipartisan Group up to make sure we are. Number two, will you ask the universities, especially the state universities how much they would lose in funding, how much they contribute to their own administrative funding for the money you give them, and whether there would be less thore more research. Include that all all in your appropriate let us know about that as well. I hope we can nip this idea in the bud. I hope its one of those ideas in the president s budget thats just out there to stir up conversation. But it is a thurely awful idea, bad policy. It would not do what i know the president wants to do which is create more american jobs, not fewer. More research, not less. And this policy would be less. And my time is up, but if you want a constructive way to get more money out of nih, look at the National Academies may i take 60 seconds just to finish up . The National Academy has done two reports. It says more than 70 of a researchers time is spent on budget tasks. So if you want to reduce some of those administrative tasks and free up more money for Research Grants, that would be a good area to work on. So maybe i could ask you to be prepared for that in the future. I want to register my strong concern for the indirect cost policy and ask you be very specific in polling universities across the country about how much money do you lose, how much money you put into research yourself and whether there may be more or Less Research. Thank you. Senator, id be happy to work with you on that. Your 60 seconds, bled right into my first 60, how about that . Because thats actually where i was beginning. Were all looking forward to quite a bit of what we saw in research and in initial levels and in clinicals moving out to the general population, getting a chance to see that. Everyone would benefit from a universal flu vax nene, aids vaccine. We very much appreciate the Ongoing Research as it benefits families all over the country and all over the world. Let me stap into what senator alexander was mentioning before on costs. One is how grants are done ask how theyre approved. And i want to talk specifically between coordination. When i talk to grant recipients, they will tell me i go apply nsf and i apply nih and wherever its close. And theyre just going wherever they can get the research. It should be up to the entities to determine. When we do with law enforcement, they can tell you the delayment. They know thats not ours, thats theirs. From the grant recipients, their eager to get the money wherever they can do it. How do we make sure were not doubling up in other areas but prioritizing that . 40 of the cost whats happening with the Research Dollars are just paperwork thats being completed, thats not helping us get to greater discovery. So what can we do to simplify the process on the research and reduce the burden for the researcher but also make sure were coordinating this from a federal level thats strategic . Senator, those are two great questions. On ways of reducing the Administrative Burden, were currently looking at ways to achieve this. I should point out that 22 of that may be the part wept to thegvers to do because thats making sure of writing the grant proposal and putting them forward. That still leaves a whole lot of other time. And we have some leaveurs we can pull at nih to try to reduce some of things, effort reporting or some other sites of conflict of interest. But some of those levers we dont hold, and that would require other systems systemically to do those reductions. How do we discover so we can help in that. I think it would be fine for you to give us a summery what those current administrative responsibilities and where they are terrific, that would be helpful. And the National Report pubblushed an issue, its a bit lengthy but we could consolidate it. Not to increase your Administrative Burden while we increase others, but we need the help. In termsf the very real concern of not having dupeication between different funding agencies, were concerned about that. We also have much better tools now of doing analytics of whats in the portfolio ear the department of energys efforts. And were looking at those with increasing intensity now to pea able to identify if there are unintended dupeications. Sometimes its good to have some efforts going on in different ways. Certainly with nsf, we have ways we can coordinate. We are meeting regularly with them to make sure thats going the way its supposed to. In some area, we have a pretty good swim laying definition. The ust da does agricultural plants and animals. Nih does those relevant to human health. And we keep pretty close tabs on those things. But we do ask when they send those grants, they have to list their support. And we have to make sure what they put there doesnt sound familiar to what theyre asking us to do. So i think for there most part we do have a lot of untended overlaps. Id love to follow up with you on if youre simultaneously applying for other areas, thats the area i see as the weak spot in that. And there has to be someone to say weve got this part of you, youve got this part of and have to figure out which lane because we need these done efficiently. Thank you. Senator sehelby. Dr. Collins, how much money overall in the u. S. , not just nih but all the governmental agencies, va, name it, is spent on Biomedical Research . And how much is spent outofthe private sector . Whatever it is, its not enough. I know that. So the nih budget, which you all have overseen, and thank you for your strong support in a very bipartisan way over many decades, this has led us to 34 billion for the fiscal year 17. The va part of this, its probably in the neighborhood of could you find that for the record. Yeah, id be happy to do that. It actually outspends in the public factor by two to one, three to one in that space. Sole were talking about an overall span in the neighborhood of 300 billion a year. How much of that is complimentary . In other words, do you coordinate with other investigators in the nih sector and other government because theres a lot of over lap there. Im glad you asked. Because theres been how do we do that . Well, we have a model thats working pretty well, which is called the accelerating medicines partnership. And this gets the scientists and the scientific leaders from the Public Sector mostly funded by nih, and the private sector and get around the table and say what are the needs that none of us can do ourselves to speed up treatments to patients . So that would be in the precomppetitive space, but theres a lot of that. So we now have a project on diabetes, alzheimers disease, and we have a project on lupus. And we just started one on lupus disease, and we put money into it from both places. Theres money on the table and skin in the game. And these projects i think are actually turning out to be successful. Were talking about hundreds of millions of dollars going into this. How much coordination is important in investing internationally with our International Friends and so forth in a public or private sector . Whats youre looking for is a cure for this, arent you in. Yes, indeed. Most scientists have collaborators that are all over the world. Certainly, when it comes to this industry interaction europe has a similar effort called imi, the innovative measures initiative. And we work closely with imi 2. Well, thats good to hear. Dr. Collins, weve discussed research, i have with you privately and here many times, involving Cystic Fibrosis and some auto immune disease such as lupus several times. I know nih has been involved in research in a lot of this. You made a lot of progress. Could you bring us uptodate first on Cystic Fibrosis, where we are . We made progress, where we going . Were looking for a cure. We are. The Cystic Fibrosis cause, the genetic glitch was discovered in my laboratory in 1989. But now we are here seeing a very effective targeted drugs. The first one only treated about 5 of cysticfibrosis that had a particular spelling in that gene. And when you look at whats happening now and this is a wonderful example of Academic Research leading to advances in the private sector. Now with a Company Called vertex, jeff liden, said were on a path to curing Cystic Fibrosis, and were not talking 100 years either. Well, youve extended the lives of a lot of children in the last year, and thats a milestone in itself. And the folks from the Cystic Fibrosis foundation have been wonderful. How many people do say are affected by Cystic Fibrosis . In the u. S. Its about 35,000 people. What about worldwide. World wooild its probably about 100,000. What about lupus . Its difficult, know. Its difficult. This amp program i just mentioned has a focus on lupus. And what theyve been doing is look at kidney biopsies from patients with loupess. Because as you know one of the the major consequences of this disease is affecting the kidney. And what theyre doing is looking at immune cells in the kidney to see whats going on. Not just a whole bunch of cells but one cell at a time. This is single cell biology. If you look one cell at a time you can find them. Now, where thats going to take us in terms of new therapeutic, right now i cant tell you. But this is another example where industry working with this project has gotten pretty excited of what this could lead to. Is the money spent over all, for all auto immune, so many things are related to our auto immune sls. Have you discovered things in basic research . I should ask theres a major effort coming from multiple institutes. Were the lead institute on this, but there are other institutes doing the same thing with the concept we call induction of immune tolerance. Auto immune disease is the inappropriate reaction of your own immune system against tissues of the body. Depending what the tissue is, lupus, auto immune thyroiditis, what were trying to do is essentially going back in the development of an individual and try to get the cells that normally would have been deleted or expressed from the time you were developing at a fetus. Because when you deep from the first part of a fetus, you have cells that develop the capability of ataicing all of your tissues. And what you do in normal development is those either get suppressed, deleted, or they get tallerized meaning they dont recognize or they dont respond appropriately to their own tissues. And we have this auto immune Intelligence Network which is working by a mechanism of numbers to determine how you can shutoff the inappropriate response without expressing your appropriate response. Because right now today the crude approach to auto immunity is to suppress the entire system, which unfortunately leads to complications like infections and other adverse events. We like to be precise, maybe come under the umbrella of precision. Exactly. Is kidney failure one of the big things dealing with lupus . There are other things, but thats the big one. Its a multisystem disease as you well know. And senator, youve shared your wifes struggle with this and i hope shes doing well now. Shes doing well thanks to medical research. Thats wonderful. As you know it affects the joints, affects the kidneys, certainly can affect other parts of the body including difficulties with the brain. So we have to piggier out what is the best way to intervene. What is the role of dna . Im going to say dana plays on Important Role in absolutely everything, but it would happen to be true in this case. Clearly there are genetic susceptibilities to lupus. Again, theyre not at the present time sufficient for us to understand exactly why some get it and some dont. You can see some are susceptible, but there has to be another trigger. We know lupus is particular comalmen in africanamerican men and women. Its often the case when you have diseases that have a pregenetic disposition. And thats what we see in all z diseases of auto immunity. Theres a link there. It is a link. Its not like one disease, one link, but it is certainly link. The senator took his rounds all at once, but he might have been asking the same questions. No, no, those were good questions. Senator moran. Thank you, mr. Chairman. While the chairman noticed you did that, i didnt. My question is this. I dont think we have the director here for this topic particularly, but ive heard from parents, advocates of Childrens Hospital directors the difficulties of improving pediatric care. Treatments and new drugs are often developed with adults rather than children in mind establishing pediatric Clinical Trials is a challenge. So id like to ask these questions. Considering the difficulties facing this patient population, what work is nih doing in research in pediatric issues and whats standing between nih and Pediatric Research that might restrict your capacity to have greater results and achieve what were looking for . Well, thanks. Youre correct that the director of National Institute for child health and Human Development is not at the table, although it would be great for you to have a chance to meet her. Shes been recently rukruted from tufs in boston. We also recognize theyre not the same as miniature adults, and they need special kinds of attention. The focus on pediatrics certainly has been a long tradition of what nih has done. I might just ask two of the folks at the table to Say Something about this. Maybe dr. Lully about pediatric cancer and dr. Gourdy about autism. Thank you, senator moran. I would like to highlight three new programs which the nci is initiating to support pediatric Cancer Research. As you may know in the last 15year period there has been a 20 decrease in mortality rates from children with cancer. But there are two serious problems. First, some children who get cancer arent helped, and second the longterm effects of children successfully treated can be devastating. So one program were nishinating is part of the use of cancer moon shot funds from the 21st cures bill, which is to develop new treatments for children with cancer. And as dr. Collins mentions, Childhood Cancer is not just adult cancer in the small sense but its qualityitatively different. And so it requires a separate kind of research effort, et cetera. So thats number one. Number two, with our regular appropriatation that congress has been generous in giving nci, were also doing what we call the provauktive questions initiative, and that is to deal with vexing problems in Pediatric Research. And number three, developing the pediatric match trial, which will be opening in the next few weeks, building on the success of the adult match trial. Its a paradigm shifting trial which first brings the treatment to the patient rather than the patient to the treatment. And second, based on molecular abnormalities of the patient rather than the kind of cancer that they have. I should also put in my Quick Response something about the oakee program, which is a new initiative at nih were excited about. So oakee stands for environmental influences on child health outcomes. This is an effort to try to collect information on more than 50,000 children in terms of environmental exposures, in terms of risk factors, following them over the course of time bringing together cohorts that hasnt been previously established or carefully scrutinized ibstandardized assays. Because theres a lot we dont understand about how that affects such things as asthma, a a childhood obesity, autism. So oako which includes an idea states Pediatric Network to basically do Clinical Research is a new investment thats new onthescene here to tray to answer this question. If you want to very quickly Say Something about autism. Okay, so the autism is not just a transnih initiative. It comes really across the dod, the department of education, of course nih, nsf and our goal to understand and formilate a Strategic Plan for autism. I would say the three really exciting ongoing things that were trying to do. First, were really trying to understand what makes a difference for childhood and how that translates into longterm outcome. Second, were trying to get a better handling onscreening, particularly the younger and younger we can identify people at high risk for autism so we can intervene earlier and also so we can learn more about what happens in these early changes. And the third is recent developments in both genetics and environmental influences to suggest things are really going on actually in the womb. Thats where things are starting. So we have to understand really aurally Neuro Development so we can do something about thel. Thank you for answering that question in a timely fashion that the senator owes he. One of the things that suggests to me that increasing funding for nih research, science brings the new knowledge which then causes us to look in a new area and a new initiative arises which suggests that the resources are growing, the need for resources continue to grow. Very new things do we get to put the check in the box and say we no longer need to look at this. But research allows us to say theres a new way, a new place, a new opportunity for us to find information through research and science that otherwise doesnt exist. So theres lots of reasons ive advocated for funding of nih that never occurred to me that just your success in finding information breeds the freed for resource to find more information. So dr. Gordon, before we go to senator kenied, there are 19 places including Washington University that are looking at the adolescent brain cognitive development. And wondered if youd give us a little update on what were seeing in those 19 locations. Id be happy to, but thats a initiative dr. Volcov really spearheaded. Dr. Volcom. Thank you very much. The idea was a concept that now we have the technologiesthality allow us noninvasively to view the human brain. And this a Noninvasive Technology thats widely available across Different Health centers in the country. So we now have the capabilities to actually monitor how the Human Brain Development develops from childhood to adolescence to adulthood. And the idea is if you can get the standards like where we kushtly do pediatrics like we have a norm that tells you whether a child is growing faster or slower, we should be able to get what are the normal distribution of Human Brain Development. So when a parent comes to a position clan kplaining the child has problems, you can actually determine the extent to which the brain is changing. These will allow us to understand for example theets of early effects of drugs on brain development. It will allow us to understand for example how Mental Illness emerges, can we detect it early on on the basis of these brain changes, and it will allow us to understand how physical the trauma, like doing sports, may have negative influence on development of the brain. How alcohol, tobacco influences factors of how our brain works. From ages 9, 10 until they reach adulthood. And we will evaluate their cognitive performance, their purchase of schools and social networks. Any investigator will be able to analyze and extract data and information from that study. Thank you. Senator kennedy. Thank you, mr. Chairman. And thanks all you doctors. I have two brothers in the medical field. Ive heard from years talk about the innovation in nih. So i was especially able to attend the meetings we had at nih that senator blunt organized. Very, very impressed. Heres my question. Lets suppose as you often do that nih or one of the institutes develops a new pharmaceutical drug or a new vaccine and obviously its developed with your creativity and intelligence and experience, but the money comes from the american taxpayer. And you develop it, its successful, it works. At some point that vaccine or that new pharmaceutical drug is turned over to the private sector to develop further and market. When that happens, how much in terms of royalty or shared compensation does nih and more to the point, the american taxpayer get . So the connection between nih research and the development of successful drugs, vaccines and devices is very strong. You can certainly point to nih funded discoveries in the majority of such instances upon which the Research Track was traveled. In some instances the nih funding was for very basic sciences, but then led the light bull bb to come on. In other instances the nih carries the funding down the line for something that is patentable and led out to a product. Because of the by dole act, that institution then holds the property, and if there are royalties that come forward, they would turn back pardon me for interrupting, doc, but as you know were limited by time. Im talking about not one of our grantees but when its nih itself. Who negotiates . What is the standard royalty . How do you know youre getting a good deal . Im not suggesting youre not. Give me the details about how you do it. Sure. So if its a discovery made by one of our own investigators, we have an office that regularly looks around to make sure they claim them if they have. Then a patent gets filed. Once that patent is filed then our office of tech transfer working with the scientist to try to figure out who would be interested in license that, then they put it out and then a negotiation begins. I think our negotiate areiators are Operator Good in terms of figuring out are they inhouse . Yes, we have our own legal staff inhouse. We employ contractors to help us for expertise if needed. But we have a very strong interneural staff. Again, im sorry to interrupt you no, please. Im down to 1 06, and i want to keep to my time you can take a bit more time. Thank you. Youre being a bit more disciplined than your colleagues, i think. Have any of you ever had the development of a pharmaceutical drug or a procedure or a vaccine that you looked at and you said this works, its a led pipe cinch, maybe you havent completed all the different phases that you need to do to convince the fda, but based on your intelligence which is considerable in your experience, i know this is it have you ever had one of those . Oh, yeah, all the time. Okay. Have we ever thought in those instances, ill call them lead pipe cinches i dont know where their came from a certainty . Youve got a certainty. Have you ever given thought, instead of farming it out to someone, lets do it ourselves . Yes. The trick there, senator, is whether the manufacturing process is something that we want to take on. We dont make pills in general except in very small amounts. Could you subthat out . You mean instead of to a pharmaceutical company, just contract it out . Thats a the time we might do that is where its a rare disease or neglected disease where theres not interest. Let me say we try not to step into the private sector where the industry capable and their success, where theyre willing to take something on. But if theyre not, tony . As it turns out, the scientific and Technical Capability of putting for example, i deal mostly with vaccines. To get a vaccine production capability outside of the already established pharmaceutical industry is almost impossible to do. Its just not out there. And our experience has been it just makes sense in the scenario you developed, if we develop the very early stages of a vaccine, which are actually in the process of doing it right now with vehiclea, and we did it with ebola. Where you do the concept development, do it an animal, phase one pretile trial, and you get into it and you always sail youre never sure until you get into the trial. But there are some you kind of have a feeling are going to work, at that stage you have to develop a relationship with the pharmaceutical company. Because our experience in the past is if when we try to get into the pharmaceutical approach, the exper tees, at the end of the day its much more economical to essentially license it to them, and let them take the ball and run with it. But we certainly have considered your model. But it just doesnt work. Okay. Well, i want to thank you. I dont doubt for a moment that any one of you could go into the private sector and quadruple your income. And money isnt everything. And i dont think you just talk that, you live it. And i just want to thank all of you. Thank you, sen tfr. Mr. Chairman. Thank you, senator. Senator kelby. Leveraging this slide here, leveraging basic science, can you put that back up there . Its Cystic Fibrosis, shows the outside of the cell, inside of the cell . You cant do it. But youre very familiar with that. Is this the lung . Well, that diagram on the left, what is that . That is actually a photograph at a very high magnification using a tech naek called cryoem. Its a protein. Its there in the lining cells of the lung as a channel that moves chloride and salt around. Until a few months ago we didnt really know what it looks like and now we do. The this a targeting approach rather than just do the shotgun approach. Exactly. Dr. Gibbons, youre involved in the lung, heart and blood. Do you overlap into Cystic Fibrosis in dealing with the lungs there . Yes, we do, senator. Like to comment on this . I http given you a chance. Certainly, again, dr. Collins is a pioneer in this area. But its also critical there have been other elements of the research. For example, he alluded to the fact that certain misspellings changed how that protein traffics in the cell. And a lot of that involved basic Cell Biology Research of those epithelial cells and where they got stuck and why. And that was very struchltal in understanding how to make a target that would then change the trajectory of that trafficking. So theres always this back and forth between not only understanding iitation but how it affects the cell, cell function and therefore the organ function on the patient. And there are other elements of the disease, unfortunately. How much pricrobial agents invade and infect of a lung, the projenination of a mucus. Thats so important as a barrier function. So there are other how do you prevent it exactly. So understanding so understanding in addition to ot strategies that can be taken to help the patient. And as you target the cells there, you were talking about, what are you, i guess youre trying to suppress the mucus some way or get rid of it. You try everything you can. One of the drugs thats turned out to be most useful in Cystic Fibrosis is something that makes that mucus more able to be removed. Its not so thick and sticky when you have it there making it more fluid so thats one approach and of course theres infections that happen in Cystic Fibrosis so antibiotics are critical including those that can be can inhaled and go right to where the problem is is but i think all of us primarily are looking to the time where you have a drug not just treating the symptoms and the consequences but actually treating the fundamental problem. The underlying problem. Thats right. When i talked about this i have to point out that the investigators that i highlighted in my conversation was from the university of alabama at birmingham thats one of the folks doing this amazing work to look at the structure of the protein at an atomic level. Dr. Gibbons what kind of time line do you see as far as, i know its hard to say its going to be three years, two years, or what, but you made so many break throughs in Cystic Fibrosis. Now you made a big one, isnt that right . Going to the fundamental thing. And if you can target that, that would change the game, would it not . Oh, absolutely. Changed the lives of so many. Absolutely. It also is perhaps a forerunner for other Rare Diseases that we understand the genetic cause of. Ones that high priority for us is Sickle Cell Disease so were excited about the emerging new technologies that existed where we can actually modify that misspelling and turn it back into the correct spelling with this Gene Editing Technology thats emerging and thats something that was really more of a glimmer before but now i think were on the threshold of so were looking forward to Rapid Advances related to correcting at a fundamental level these genetic disorders. Thank you mr. Chairman. Thank you. Well, you can see lots of continued interest in everything that youre doing and were glad you here. Do you have a final comment . I just wanted to say thank you mr. Chairman to you and the members of this committee to your support of what all of my colleagues and i believe is a remarkable moment in history and i also want to take the moment to allow me to introduce to you the future senator from michigan, my granddaughter sitting back here. So bailey stand up. Wonderful. I dream of a day where she doesnt have to worry about on behalf of her children or grand children or grandfather. But i want to say thank you to all of you for your support. Thank you for being here. We hope youre still playing your guitar and riding your motorcycle with enthusiasm 20 years from now. Thanks for your directors for joining you today. The records stay open for one week for additional directions and the subcommittee will stand to recess until june 27th. [indiscernible] [indiscernible] online at cspan. Org and on the cspan radio app. Sunday on q and a. Anybody thinking in 1962 after nixons last press conference ten years later he would win a 49 state landslide and then it all came apart. Columnist and political commentator served as a speech writer and Senior Adviser to president nixon and discusses his book nixons white house wars. The battle that made and broke the president and divided america forever. Do you not even think theyre going to be that damaging to us and should take it out and burn it and shutdown it into a monster. And entertain this idea that he should burn the tapes and he said well it would be obstruction of justice. Didnt recommend burning subpoena tapes. They were his property and executive privilege existed. Everybody knew it and if he simply got rid of them and said that he would have moved right through it and president nixon said in his memoirs if he had burned the tapes as i had urged him to do he would have survived and i think thats right. Sunday night at 8 00 eastern on cspan q and a. The Supreme Court ruled 72 that missouris denial of public funds to resurface a Church School playground violates the first amendments establishment clause. This is the first time is the Supreme Court and matter of