the tenet appropriation subcommittee on labor, health and human services, education and related agencies will now come to order. today we are having a hearing on the biden administration fiscal year 2023 budget request, for the national institutes of health. senator blunt and i will each have an opening statement, and then i will introduce our witnesses and after their testimony senators will each have five minutes for around questions. what we were unable to have this hearing fully open to the public or media for in-person attendance, live video is available on our committee website. if you are in need of accommodations, including close captioning, you can reach out to the committee or the office of congressional accessibility services. every day across my home state of washington, research inches the research of washington, washington state university, seattle children's hospital, so many other world class institutions are working around the clock and making groundbreaking discoveries. discoveries that don't just drive innovation in economic growth but also bring families cures, treatments, and hope for the future. discoveries that save lives. discoveries that don't just drive innovation and economic growth, but also bring families cures, treatments, and hope for the future -- i am pleased to say that this budget request shows that the administration understands the tremendous importance of administrating the final world of -- and our tradition of global leader here. especially as the past years have been such a stark reminder of the investments we make and research day, pay off down the road the rapid development of safe affective covid vaccines, was made possible by researching into mrna vaccines we funded and response to ebola and other viruses. but bio medical research enterprises, built over decades. today, thanks to the back scene and their punic's, and the research we help develop, covid deaths and hospitalizations are the lowest we have seen in two years. however, we are not out of the woods yet when it comes to this pandemic. there is still the threat of new more deadly variants, especially right now, in case loads are inching up again. but our communities resources have largely been spent down. we need to defend the progress we have made. and that means passing i'm urgency covid funding, so our community can have the tests and treatments and vaccines and tools they need to keep families safe. this is really urgent, i will keep fighting to make sure that we get it done. in addition to providing our communities research that they need to fight this pandemic, i hope we are able to come together this year, as we have so many times in the past, to continue providing our researchers, what they need to help us to fight covid-19, and so many other challenges. challenges like developing better tests. making next generation vaccines, better effective against all covid variants. and understanding, long covid, and how we support the millions of people who are living with it. and challenges like the mental health crisis this pandemic has made so much worse, especially for young people. overdose deaths that have been skyrocketing due to the rise of fentanyl. we have a record of 107,000 people to overdose deaths in a single year. and washington state, opioid deaths increase -- increased by two thirds in 2021. it is tearing a hole in so many communities and so many families, it is truly heartbreaking, we have to pull out all the stops, to get this under control. that is why i am working on bipartisan legislation, to strengthen programs, that help our first responders, health care professionals, and others on the front line. why i want to make sure that we continue investing in research here, of course, the measure of success against any disease is not how much we invest to fight it, it is how much we are helping patients. for example, when it comes to alzheimer's disease, it is exactly what we need to be focused on. for patients fighting this disease, the stakes are intensely personal. they are fighting to hold on to cherished memories of loved ones, and a feeling of control over their daily lives. and the weight of that fight, falls on their family members, friends, and caregivers. with so much at stake in their lives, these families deserve to know that the research projects they are depending on, are being thoughtfully designed and prioritized, for meaningful outcomes and results. this is really important for me, especially with increased funding for alzheimer's research in 2015. when the 2025 target date is established in the national alzheimer project act, it's just around the corner. when there are so many other terrible diseases that are desperate to put more research into it as well. another important undertaking is the launch of the advanced research project authority for health. which aims to break the mold for how cutting edge research is conducted. with the discovery of medical treatment, and projects that have the potential to transform medicine. i worked hard to provide researchers to establish a bipartisan funding bill this year. i am working hard right now to pass prevent the pandemic -- to set it up for long term success. that requires striking of balance. to ensure we can compliment nih we'll still operating independently, to seize the opportunities to accelerate innovation and breakthroughs. i'm really focused on getting that balance right. i will be asking more about why so much of the and i h budding increase, requested by the administration, goes for -- when it is yet to bring on its staff. and what that means for the other nih institute senators. of course, at the end of the day, innovation is not driven by new programs, and new investments. it is driven by people. which is why, with as much as we invest each year, and as important as this work is to our families. we cannot afford to have this agency's potential-limited, or success threatened by biased discrimination, or harassment in the workplace. we have to do more to address harassment in the biomedical research community. as well as address the facts and the number of research -- and even clinical trials, often failed to be adequately represented. these are real problems, with real consequences, to research. and i have been pressing for progress on this, for years. i have been glad to see and i it's working to examine barriers, in diversity among the returners, addressed how it practices, and structural biases and discrimination, and implementing a policy, i've secured in this committee, that requires those that receive nih grants, to notify the agency, when a principal investigator is removed, even temporarily, for sexual -- that work remains to be done, to remove racism, discrimination and harassment from research. i will continue to follow up on the progress here. finally, before i send it over to senator blunt, i just want to take a moment to note that, this will be the last nih hearing, we have with him. and to say, how grateful i am, senator blunt, with all the work you have done over the years, for this issue. it's great to have a partner who really understands why these investments are so important to families. washington state, missouri, and across the country. and really willing to sit down and work on a bipartisan way that make sure we are delivering for folks who are expected. thank you senator blunt, i'll return it to you. >> thank you chair. i appreciate the work we have done together, as you said, in all likelihood, this is my last nih hearing, as i have started to look back on the time i have spent in the senate. one of the things, i think we'll have the most long term impact, is what we have done together. for nih research. you have been a great partner in that effort. we work closely with chairman the laura, and congressman cole. that is subcommittee, and share the committee during the eight years that we have been doing this work together. the entire committee of course, was involved. i would like particularly like to mention senator durbin. and former senator alexander who were right there at the beginning, trying to see what we could do to change a trajectory that really was, not good. of course, doctor, thank you for you, and the directors being here with us today. like all of you would remember i became chairman nearly eight years ago. and i h funding was stagnant, and had been for about a decade. over the past seven years working together, we've increased that funding by nearly 50%. it was a period of time of looking back, and i could only count on sustain funding but also having substantial increase every year. i am hopeful and confident that senator murray's continued partnership, and that commitment, will let us do that again, this year. i hope we are able to successfully work together, and have a bill this year. i'm disappointed that this budget request reduces funding for 12 of the 27 institutes. including the national cancer institute, and the national institute of allergy and infectious diseases. the latter of course, was demonstrated over and over again, how important it was during covid. there are very few increases, frankly. that are proposed in this request. and, one light the cures, of the increase in cures is coincidental and this fy 23 year, has that number, already built in the only significant increase is that the chair is pointed out, and i age this year would be an increase of four billion dollars -- i'm a supporter of arpa h. i'm a supporter of the secretary's decision to have it associated with nih. four billion dollar increase from arpa-h and no increase for nih would really verify the words concerns that people have had about arpa-h as a competitor to our ongoing research, as opposed to finding a way where the government can and should be willing to take on more financial risks, become a real partner in targeted research outcomes, that have a specific short term goal in mind, and help us reach that goal. that does not mean we should jeopardize research challenges, as big as a cancer and alzheimer's disease. or as small as hearing aids. as we look to build frankly, the goal of doing more of what we were able to do in the pandemic. i was also surprised budget requests failed to take more of the lessons learned from the pandemic into consideration, instead of embracing more high risk high reward science and focusing on projects with instant impacts which proves so successful with programs like red x, it appears that the budget cut bogged down with political priorities that don't quite fit the agency's long-standing mission. this is clearly illustrated, with the request of a new senator for sexual orientation and gender identity at virtually no additional money for the cancer moon shot. nih is clearly in a period of transition. if there is one lesson to be learned from the covid-19 pandemic, it is that our nations success depends on medical research infrastructure across the country, supported by nih. now is not the time to abandon that goal. now is the time, in fact, to make it even stronger. i hope the original, eventual budget that we propose to our colleagues in the senate and to the whole congress will reflect that determination to make and i h stronger, across the board rather than the way this budget proposal looks at nih. chair, thank you for your comments. and for the chance to speak in for this hearing. >> thank you. i will now introduce our witnesses. we have dr. lawrence tabak acting director of national institutes of health dr. anthony fauci head of national institute of allergy and infectious diseases dr. gary gibbons director of national heart, lung, and blood institute doctor joshua gordon director of national institute of mental health and doctor nora volkow director of national institute on drug abuse. welcome to all of you, thank you for being here today. acting director tabak you may deliver your opening remarks. >> thank you chairman murray, ranking member blunt and distinguished subcommittee members. i'm on the to be here today with some of my colleagues representing the nih. this is a time for and the entire biomedical research community to re-examine all of our efforts. during the covid-19 pandemic, we were driven by the urgency of the moment. nih must learn from this experience and sees the opportunity to define a new normal. as acting director, i am committed to new strategies, new voices, and a renewed focus on the future. now is time to reflect on what worked and did not work in addressing covid into shape new strategies. setting the stage for the new mrna technology of image and design that were key to developing the safe and effective vaccine in unprecedented timeline. since these vaccines became available, it is estimated that more than 2 million american lives were saved and more than 17 million hospitalizations were reverted, now we need continued support for a wide range of biomedical fields, including behavioral and social sciences, to identify and successfully implemented better ways of responding to short and long term health effects of covid-19. to prepare for future pandemics. and to ensure equitable protection of our diverse population. it is not just about vaccines. our rapid acceleration of diagnostics, or read an x initiative fueled the development of many new initiatives of covid tested that are being used in our communities. top ensure that such benefits would help with those disproportionately affected by the pandemic we initiated underserved population and the antigen community engagement alliance. these experiences along with other nih led efforts focused on co-treatments of the private and public partnerships nih can build upon the momentum of the covid response to develop other challenges through radx. thank you for the authorities of key development including the omnibus, and the aim of the basic administration of infrastructure for arpa h. this is a key first step for the permanent home of strategic partnerships that are so urgently needed to address cancer, bile leading to alzheimer's, and many other by diseases. we cannot stop there. in addition to new strategies, biomedical needs new voices. a growing body of evidence demonstrates that inclusion of diverse perspective yields better outcomes. in a clinical setting, medical teams provide diverse more accurate diagnoses for more patients and building trust. we do better science when we have a diversity of scientists from different backgrounds and different communities. scientific fields, and a different story or stages. senate appropriations subcommittee on labor, health and human services, education, and related agencies continues to prioritize early stage investigators so that they can succeed as independent researchers. in 2021, we reached an all-time high over the stage investment, 1313. the passion and commitment of our scientist is matched by the people living with a wide range of diseases and can be conditions. conversations we are having are sometimes difficult, but those are often the discussions of teach us the most. from the age advocacy groups of the 1980, to today's groups for autism, along with covid and many others, these voices have refused to be ignored. ultimately all of us benefit. this is a movement for renewed focused on the future. i spent a lot of time encouraging early state scientists. i also like to think about the importance of engaging elementary school age children, like those my wife has taught for over 40 years. during the covid pandemic, exposure to the importance of science has become a big part of many of their lives. past pandemics have inspired young people to become scientists. the images they saw were usually of older man who looked pretty much like me hopefully today's kids are seeing more scientists that look like them. we need to do better. our nation needs all the bright minds they can find. i hope they will continue to work with the way nih to make this happen. thank you for your time, my colleagues and i welcome your questions. >> thank you very much. i realize that as i was going to the list of panelists in front of us that i missed doctor richard hodes. . i have my we will now be in a round of five minute questions. doctor -- and i mentioned in my opening statement overdose death begin to rise drastically. much like the rest of the country, it is really driven by fentanyl. this is really a national crisis. we have to be using every tool that we have two some you are communities, including fentanyl strips. secretary becerra mentioned at his hearing here a few weeks ago. the research that i have seen that those trips are used to determine fundamental to test other drugs. they have many steps, including chipping off the pedal to be able to test it. can you tell us about the research says on the effectiveness on those test trips? are that easy to use? can you talk a little bit about that. >> thank you very much for that question. indeed the fentanyl test trips that are being used for sensitivity and specificity. the data shows the high sensitivity, and they are only a few fantino analog that are not detected. the fentanyl test trips were developed for testing urine. so patients who are being monitored. so this is a new application. as a result of that there can be problems on how is it implemented. overall, patients who have used the fence about test rip report positive outcomes. actually in terms of identifying terms of higher risk. now, what are the optimum guidelines of how to use these? number two, if the results are positive, what should that individual do in the case that they don't want to consume them. as you know, there are still multiple problems in terms of making these fentanyl tests available throughout the united states. there is interest on actually determining on getting some food and drug administration which can be used in health care settings, which is not possible at this moment. >> are there other overdose prevention strategies that you hope to roll out in the coming months? talk to me a little bit about what we are doing in terms of prevention. >> prevention strategies that have been shown to be wildly effective is perhaps one of the most important ones, widespread distribution of naloxone. that becomes a challenge because naloxone is not necessarily available for those who use these drugs. another harvard action practice that have generated a lot of attention is -- the drug supply is so extremely dangerous these days, we have safe injection sites could be valuable for patients who otherwise may be at very high risk of overdosing, and while the data is still preliminary in the united states, in other countries that have shown that in certain settings it can be quite effective so there is interest on evaluating them. there is also interest in their community to test other products that may serve for samples that include trenton, which is sold as t, and contains a drug molecule that has effects that are similar to those of -- could be utilized for decreasing withdrawal, depression. these are more novel and we do not have sufficient data. those are things that are being discussed. >> perfect. thank you. doctor, it is said that science is a marathon not a sprint. congress has really invested in research to treat alzheimer's disease, with a sense of urgency. 17 billion since 2015, to really supercharged the discovery process. the goal of finding a treatment for a cure by 2025, i'm concerned that, given the sheer scale of federal investment, what is -- to deliver meaningful outcome on this progress towards finding affective treatment? >> thank you for that critical question. let me answer very briefly. and with some examples of meaningful accomplishments during this time. as you know, we've counted on critical input from the national global resource community, advocates, with our annual summits. all which feet into a careful identification of a milestone, goals and targets for the necessary mean to meet our necessary needs. i want to take a moment to thank our committee, to help us focus on these milestones, and finding meaningful, quantifiable milestones, that are transparent and -- such an example of important invents mince, that's why with pharmacological trials. we there later stages, tip on identify definitive outcomes, which are due over the next year, to reveal their answers. there are 62 early days of clinical trial, and a variety of targets, these are results that, basic science, which has found more and more potential targets. the clinical trials are critically important. he looted as well to the burden on families, and those living with dementia, an area of clinical research on trial, we are now finding a large number of trials studying interventions for care and care providing, which will be producing their results. national academies have identified two of those. that already for dissemination. happy to elaborate as time allows. some of these examples of accomplishments, are imported process, continuing to be accountable to ourselves, in our public, to make the most use of these critical funds. to accomplish the highest priorities. >> thank, you i think transparency is really important. the deadline is right around the corner. we have put out a lot of money for this, we need to know if congress will how those investments are going. >> thank you chair. we during the time that you are deputy director, the seven hearings we've had, doctor collins i think every single time he talked about the importance of nih bringing hope to millions, i want to talk a little bit about, the proposed ending of funding for the undiagnosed disease that work. we have one of those, st. louis infirmary has won. seattle, i've had somebody reach out to me a couple of weeks ago. michelle herndon from missouri, she was concerned because her son mitchell who had suffered from a series of health issues, that doctors could not diagnose what, had benefited from one of the senators. in fact by late high school, he was in a wheelchair. his hearing was gone, his eyesight was gone. they were losing hope. after they had sought treatment, the undiagnosed disease network, st. louis, they found a neurological condition so rare, they did not even have a name. mitchell lost his battle. the condition he had, now carries his name. the mitchell syndrome. but michelle and her family, were comforted by the fact that they finally knew with long struggle had been about. this year's budget cuts the undiagnosed disease network, and closes all 12 of these clinical sites. she was concerned about that, i am to. i think there is some discussion, well they may graduate, in some way to where they continue to exist i think it would be a problem to walk away from that. not everybody can come to nih and bethesda, and if you do not have a site within some reasonable distance you are unlikely to get this service you want to talk about why that decision was made? to stop funding these 12 sites? >> we certainly agree that the diagnostic services provided by the undiagnosed disease network, are extremely valuable to patients into their families. the challenge that we face, it comes to a point where the diagnoses become part of standard prayer, versus a research question. finding that right balance is something that we continue to work through. all the cases that are enrolled presently, will continue to undergo comprehensive evaluation. we will establish data management and coordinating center, to draw upon the experience of all of these centers that are participating in this program. really, we would like to work with you, going forward. to come up perhaps with a better solution in the mid and long term. >> let's continue to work on that. you can't have standard care, if you are still discovering things. and need to be look at that as an option. mitchell syndrome, as mitchell syndrome, only because he was the first and maybe the only diagnosed person so far, that never had that. it is going to fall outside of standard care definition, i think. let's continue to work on that. is doctor gordon available? let me ask him on the red ex, doctor gordon, in the mental health area, and the red ex example of nih itself, partnering indirectly with others to try and find a rapid solution, do you think that shark tank red x kind of option would be possible, to look for biomarkers? and mental health? >> that's a great idea senator. i appreciate your support. of that initiative, we have funded a number of small businesses, as well as a number of academics who have come up with really wonderful ideas, for biomarkers that can help guide clinical decision-making. something we desperately need. to help people who need treatment, get the right treatment from the get-go. one of the ideas we have been thinking about is, using the red ex example where, you had essentially a competition between a number of different companies. red x, it was protests, for covid. the idea is to play something like that to the biomarker space for mental health. and we think now, it's the right time to do that. we are talking with our colleagues, who ran the red x competition, trying to figure out how we can do that for biomarkers, for the help. >> i encourage that. i think every single home test for covid comes out of the red ex experience. again, if you have people that have ideas that can come to you, and try to see which of those should partner with, i think that would be a great step in the right direction. thank you chair. >> thank you madam chairman. doctor quoted, we are in the midst of a significant spike in suicides. among children, which is very disturbing. we know some of that is a result of the pandemic. i am interested in wet research -- pursuing this issue, how is that research being operationalized, and put out two practitioners? particularly to families. the other point would be, we have a new national hotline, 988. -- >> the answer to both those questions is yes, we are deeply involved to make sure our research informs practitioners in both in the clinic and at the state level, when we are talking about 988. we talk about a youth suicide first, and i mh as funded a number of different research programs, and identifying individuals risk, particularly the young, and getting to evidence based care. one quick example the program developed a streaming questionnaire called the a s q. it has been disseminated to primary care practices, and pediatric emergency rooms across the country. being used nationwide. we also have funded a number of research projects, looking at school based identification and prevention measures as well. we do our best to make sure that they are out there. we also work with federal partners, for substance abuse, and mental health. and there, we are working with them, especially around the 988. looking to make sure that states that are implementing the followups 2988 are aware of evidence based approaches to mental health crises. for example, the properly is a shun of -- teams that are trained to response individuals who are in mental health crises, is one evidence based approach that has been proven to work. we continue to work in both of those areas. thank you. >> thank you. doctor fauci the issue of long haul covid has been in the news lately. can you describe how nih is tracking these cases? are there common elements? or they're treatments showing? any promise? where are we in these responses? >> thank you for that question senator. i will begin the answer, and i'll hand it over to dr. davis, who is also very much involved in this. as you all know, this is a real phenomenon. and, the epidemiology of it is still being worked out. the range of people, anywhere from 5%, to up to 30% of people, have persistence of symptoms that are not thoroughly explainable. by any pathogenic process that we have been able to identify. we put together large cohorts, that are now being followed. both to understand the actual prevalence, as well as the path of genesis, with regard to treatment senator, it is very difficult to do any treatment for, it when you do not know exactly what the pathogenic mechanisms are. that is the reason why we are putting so much effort into trying to find out, just what is going on. is it immune activation? is it persistence? a virus? not necessarily replication, maybe particles of the virus. but let me handed over to doctor gibbs, who can tell you a little bit about that. >> to add to dr. fauci's comments, we are indeed setting up research for recovery efforts. it is moving with a great sense of urgency, given the suffering of that patients with long covid. the number of elements, it launched very effectively, what is to create electronic health records, there they are derived from 60 million records, of patients across a diverse body of patients. of which, the obtained 45 million -- that provides an opportunity to attract those individuals electronically, and digitally, longitudinally. and to see who develops long covid, who does not. that can inform us, as dr. fauci mentioned, understanding the prevalence as well as the risk factors, and the long term effects chronically. it's already starting to show preliminary evidence, that is suggestive of potentially the ability of vaccination to prevent the development of long covid. similarly we are seeing signals that are telling us, that the severity of acute covid has bearing on your susceptibility to develop long covid. similarly, we are seeing trends towards, who is most affected? again it is identified and people of color. african americans, latinos, developing long covid, really, has not come to the floor as much. we are learning, as we go into development. >> thank you very much. we have pre-authorized the star act. the best thing we have done in a long time. and, i think you agree, -- >> thank you. >> thank you madam chair doctor. what's national institute of health has done, and continues to, do is nothing short of extraordinary. it is really breathtaking, i want to thank you and your colleagues for doing that we've all been to pandemic school the last several years i want to use the few minutes i have, to explore what we have learned doctor fauci whether you ask for it or not, you have sort of been the governments face on a response to the pandemic. looking back, and i recognize that hindsight is crystal clear. looking back. do you think it was worth it? do you think the benefits were greater than the costs? of closing down our elementary and secondary schools? >> i think it's very difficult to give a definitive answer to that. i know, in the very beginning, when we had really no other protection prior to vaccinations that were available to contain somewhat the spread of the virus, one of the things that was felt to be important would be to protect children as well as the rest of the population. right now, we have built more than just recently, this very important to keep the children in school. for the simple reason that, we know of the effects, both psychologically mentally and developmentally in children to keep them out of school. but you have to have a delicate balance. between protecting the children, from getting infected, >> i believe that we have. it's very tough to tell. i think only time will tell whether that is the case. because there is indication that has been diligently us effects on children. we believe from a public health standpoint, that at the time, it was the right decision. >> can i ask you this, i realize, i'm not saying we're offering judgment on what was done at the time. i am asking what we have learned. >> let's suppose we have a substantial increase in prevalence of the coronavirus next week. god forbid. with cdc recommends shutting down the elementary and secondary school? >> it's very difficult for me to speak for the cdc. knowing the fact that -- >> would you recommend it? >> i would do everything we can to keep the children in school and not shut down the school. the childrenthat has always beg recommendation. for it to be possible, not to keep the children out of school. but to keep them safely in school by, getting children who are available to be vaccinated vaccinated. to get the children who are eligible to be boosted vaccinated. and to surround the children with teachers and personnel in the school who are vaccinated. that is the best way to protect the children, while keeping them in school. >> let me ask you this. in hindsight. knowing what you know now. had you known and then, did we do the right thing? and shutting down society. would we have been better off saying no, we are going to protect the vulnerable. the elderly. the people who are immunocompromised and, we are going to isolate them, but have the rest of american society, churches, businesses, universities, schools, go on about their business. well at the same time, providing them guidance about how to protect themselves? >> it's a complicated question, i will try and give a simple answer. i think, there is a misconception about who the vulnerable are. there are many more vulnerable's in society, and there is a man's conception -- >> i am about to run out of time. let's assume we can agree on a definition. >> i don't think you can. i think society is very heterogeneous. it is not a question of shutting down completely senator, we never really shut down completely. if you do shut down a society, you do it for a purpose. the purpose is, at that period of time, when you are protecting people from interaction, that you get as many people vaccinated, as you possibly can. >> i'm going to run out of time. let me ask you one last question. what would you do differently today? >> right now, i would hope that we would get many more people vaccinated. >> what would you do when you did it, in hindsight, if you knew then what you know today? >> it depends on when we got the vaccine. you mean it before the availability of vaccines? before the ability of vaccine, when we had no other situation, i would try to protect people by making sure, that they masked, and they kept themselves separated, from this congregate indoor setting. that is what i would do. in the absence of a vaccine. right now, i think it is important. looking forward, we still only have 66% of the total population vaccinated. and less than half of those, or boosted. i think we can approach what we are likely going to be seeing, seeing now with an increase in surges, with the possibility of a surge in the fall and winter, one of the real things we can all do, as a nation, is pull together and try to get our people vaccinated. and those who are eligible to be boosted, boosted. that would solve a lot of the problems that you are referring to. >> thank you. >> thank you madam chair. welcome dr.. i am posing the first question to you for an update on research efforts. to better respond to the substance use epidemic. by way of context. as you well know the substance use epidemic continues to ravage communities across wisconsin. and across the united states. an increasingly, dangerous role is played by synthetic opioids such as fentanyl. as well as cycle stimulates like methamphetamine's. i believe, it is vital that we invest in sustained research, and substance abuse disorders, to prevent deaths, to be patient, and make our communities safer. if you could describe recent research efforts, including what is happening with the initiative to end addiction long term initiative, i would appreciate that. >> if i may, turn to dr. voca, who is our expert in this field. >> absolutely. >> thank you for the question, it's actually going from the basic to help develop medication with new targets. that can be actually, lead to better outcomes. to help better understand the changing phase, of the overdose crisis. which now, as you are mentioning, is no longer just-limited by overdoses. but encompasses fantino, amphetamines, and cocaine. to implementation research, that can help us determine what are the optimal models of care, that we can deploy in community, and to take advantage of a structure. for example, researchers ongoing to determine how the health care system can be involved in the prevention and treatment of substance abuse disorders. how can we bring treatments to justice -- and maximize the possibility of these individuals to get health care. to the involvement of community, so we can actually integrate the effort between health care, justice, and community. the initiative, we have been able to accelerate basically also, another area that has been neglected overall, which is the need for better treatment of management of severe pain. if we do not address the need of patients suffering from severe pain, we keep them as being very vulnerable. to seeking out much more dangerous drugs. finally, we need to ask ourselves. -- making americans so vulnerable to the use of this drug? this is relevant to prevention. if we do not understand it, and we cannot do interventions, to actually protect our souls, because of circumstances alien to them, -- ultimately developed addictions or overdose. >> i appreciate your response was dr. fauci, the u.s. was able to bring covid-19 vaccine to the public, in record time. i'm grateful for the work of so many that made that possible. including, several who are in this room. unfortunately, the next pandemic, driven by an unknown disease x, will come. and, i believe we cannot wait. we could invest in the development of novel antivirals and vaccines and diagnostics for unknown threats priority viral families. now, so that were better prepared in the future, can you explain how the investments we have made over time, at an a h, nih, across the central government, made the covid-19 vaccines, and medical countermeasures possible? and, how would sustained investments to develop responses to viral families of concern, make us better prepared? >> thank you for that question senator. yes, it's very clear that the investment in basic and critical and biomedical research, for at least a few decades, and maybe more prior to the realization that we are dealing with a new historic pandemic, allowed us to do something that was completely unprecedented. two examples of that, of the work that was done on what we call vaccine platforms, mrna vaccine which was fundamental basic research on how to get the mrna molecules, is actually service a platform of vaccine. work in our own campus, as well as nih funded investigations throughout the world, also worked on what's called, -- to do work that led to the ability to stabilize the optimal ammunition. in which case, it was the spike protein. which allowed us to go from realization of a new pathogen on january 9th, tenth 2020, getting into phase one trial, 65 days an 11 months -- having safe and effective vaccines. we did that because of the investment you are referring to. right now, looking forward, we have what is called a prototype pandemic preparedness plan. which does exactly what i believe you're looting to. develops another a families, about 20 families are at high risk. but seven families of viruses that, if you do the fundamental work of looking at the commonalities among them, and developing diagnostic tests essays, immune -- and do that now, if we do not get the resources now, congress has been very generous to us up to now. if you do not get the resources we need, we are not going to be able to do the kind of preparedness, not only for vaccine, but also for targeted developments of any viral's. which we did so successfully with hiv. and did quite successfully right now. but we have programs that are not going to get off the ground, unless we get funding. fundamental basic and clinical research is the core of everything that will protect us in the future. thank you. future.>> thank you madam chair. i'm gonna have two questions. i would like doctor fauci to answer each of the two questions. i will start with this one. and navigating through the entirety of what we did to fight covid, clearly, the most expensive feature of that navigation, would have been lockdowns. we did that out of certainty. we had no idea, how that was going to work. even in the business iran, we had early dustup's where we had a case, and i cleared up a warehouse. real quickly, understood we don't throw caution to the win. and you take basic information that we all have to deal with. and you took it seriously. you put protocols in. let's look at lockdowns. it cost us trillions of dollars. and, we are paying for that now, with super high inflation. i'm interested in, is what john hopkins, comes out with a study, saying basically that did not have any impact on mortality. i do not know that that study addressed what mortality might have been impacted. in terms of differing other health care, can we take lockdowns off the table? in terms of what we do in the future? >> i can't say because i do not know what that future holds for us. if you have a pathogen that is very virulent, very infectious. >> i assume it's in the same modality as what we have been navigating through, over the last couple three years. >> i think the official presentation of the virus was one that was devastating. it killed a lot of people. what about the study that john hopkins did? we are always saying, pay attention to the science. >> i am not familiar with that study, sir. >> doctor fauci? >> that's a very good question, if you are going to lockdown you have got to use it temporarily for a reason to prepare you to unlock down, get the public prepare for that. right now, looking forward, i do not need the need for lockdown in the future. unless something very unusual happens. the reason is, what we really need to do is we need to get our population vaccinated. we need to get them boosted. that would completely obviate the need to lock anything down. right now if you asked me the question looking forward, do i see, even if we do get a new variant, i do think the vaccination that we have has enough cross reactivity. our ability, with proper resources, to make variants pacific buses, i did not see lockdown in the future. i think lockdown is a temporary thing to be able to get you to save quickly, to save lives. >> that is good to hear. in that moment of on certainty, i don't think we can afford to do it again. i hope the biden administration is listening to that. another question, i lead the effort on this, when we took this and still get down to either, get a vaccine or you lose your job. thank goodness we did marshall bipartisan support saying that that did not make sense that supreme court use that as a cue you know in terms of what they did to fabricate that. in the future, will we heed what the supreme court said and that you wouldn't calculate even though you might not disagree that vaccines are an important tool which your preventative. would you push to do the same thing that we almost did that would've been the second calamity to occur would currents of what it would've cost of the economy. and to not benefit from results that would've been measurable. doctor tabak and then doctor fauci? >> as you know, vaccination is the single most effective preventative measure. to the extent that the law allows, we are going -- >> would you recommend that we go down that path again? down to 100 employees in a business? where you say get a vaccine or lose your job. >> that is a policy call, sir, i do not make those calls. >> again it is a policy call. i would hope that we would marshal everybody both sides of the aisle to get out there to encourage to get everyone get vaccinated if they did then we might not even have to dress this question. i do not like mandating things. i do not like punishing people for not doing something. but i would hope that they realize that looking at the data, you made appropriate statement senator, a moment ago. following the science. if you look at the data, i have the differences between vaccinated and unvaccinated people for hospitalization and death, it is striking what it is! as a public health person i would say when we all come together to get people vaccinated, we won't have to worry about essentially putting appears and is in fact a penalty that if you don't. >> a key to that navigation is pay tension to the data and the science, not the political science. >> right, exactly. thank you. >> thank you, senator rubio. >> thank you, thank you all for being here. doctor tabak, let me start with this question. we have recently seen not just the biden administration but the biden administration and other in the policy realm acting to, actively promoting supporting the use of things like hormone therapy for young boys and girls. i want to sort a limit my question for minors, what they determine as gender transforming care. that is not an fda approved to use for purity blockers in hormone therapy. i don't believe that any people, especially minors. as the week nih is america's medical research agency, what work have we done that nih to determine if this non fda approved use of these medicines, off label use of these medicines is appropriate for minors, seeking gender transforming care? >> nih funds a small number of observational studies to gather data on the effects of these treatments. transgender youth have chosen, along with their parents. there is also a small number of studies that describe the health issues and risks, including hiv, that are unique to these transgender youth. all of the research in the space is observational. we do know interdimensional work. >> i guess my question, before one thing, is a decision made by an adult right? especially given the irreversible nature of some of these treatments, isn't there some wisdom in the notion that before policy makers are out there promoting the off label use of medication that leads to permanent changes, that there be some more research done on its impact and five, ten, 15 20 years from now? >> as you know, transgender youth are more vulnerable to depression, anxiety, engaging in self harm. and so it is important that we examine and evaluate they potential effects of these treatments. researchers are observing longer term psychological impact of these protocols. so by looking at individuals, transgender youth, with a without history of which he really or depression will be able to better answer the questions that you are presenting. >> i guess that's my point, we don't know the long term implications are when we weigh the cost and benefit. the fda has approved this. we have policymakers promoting it. i think that's an important point. could you don't want anyone harming themselves, things of this nature. but we don't know if these policies, decisions being made on the observation guidance in your own admission without any long term trajectory in terms of long term impact. doctor fauci, i am running -- i will leave the united states is the only major in western country than now require citizens to test negative for covid before they can get an airplane when they re-enter the country, i believe that's accurate. on the other hand, we are hearing now that for example title 42, which is the covid era policy which should be lifted because we reached the point now where covid is manageable, not at a point where we actually need title 42. we obviously know we have a problem at our southern border, every day with people entering the border, illegally. many are not need to be tested for covid. even if they, are they are being allowed to stay. as title 42 -- how did we tell american citizens if you test positive even if a dead virus it's been a new system for ten days, you can test positive even ten days after being infectious, you can't enter your own country. but, if you arrive illegally, whether you test positive or not, if you say the magic words asylum you get to stay in the country. this is a real life scenario. they test positive, they are not sick, maybe they were -- they cannot afford to continue to pay for hotel rooms staying overseas until they can finally score a negative test. as the time come for us to, in your view, having been so intercoastal in our covid response, and we had a point now where american citizens should be allowed to return to the country without testing negative? >> thank you for the question, that is an important question. i do not have the answer to that. we work with our cdc colleagues to continue to examine the feasibility of that. the desirability of that, i think the idea of having an immigration issue mix with a public health issue for the general population i think those probably should be separated. >> except they're interrelated except they both involve groups of people entering the united states. one group of citizens of the country, entering legally. the other group, frankly, not entering legally. the group not entering legally, even if they test positive, they get to stay. the american citizen cannot re-enter their own country, until they produce a negative test. my point is, we have reached a point in covid where we no longer need title 42 as a covid restriction for illegal entry. why do we still need travel restrictions for american for return to their own country. that is the general form of the question? it seems to bother me a lot. >> yeah. >> okay, thank. you >> think. you >> doctor fauci you talked a little bit about this. i want to go back to it again. i'm really pushing for congress to pass additional emergency covid funding to make sure that our communities have the test and the treatments in the vaccines they need to keep their family safe. i understand that your institute is supporting research on the development of these next generation vaccines that protect against multiple variants. what can you tell us about the progress of the research? what does the nih need to see it to completion? >> thank you for that question. the progress has been substantial, to get what we call universal -- and that is probably too broad a term, to get a vaccine that works against multiple variants of sars covid two is the first step. there will be something where you get a vaccine directed against the common component of all of the variants or has each of the components of the variants, for example in a nanoparticle in a mosaic of multiple component to it. we have studied right now gone from preclinical, in an animal model into a human study. the results actually look very promising. the next step would be to get a vaccine that not only would be against it all variants of sars covid two but against all of those groups of variants including what we call the special viruses, that overlap with the viruses we see in many bats. which are almost certainly the original source of these viruses, jumping species and going into humans. and we are going along very, very, well we have a number of investigators people established in the field in new investigators. but we cannot continue without additional resources. that is really one of the things that is very, very, difficult for us. the scientific opportunity is there, we really feel that we do have this not only as an aspirational goal but we will be able to get that goal of getting a vaccine that would protect us against both known and unknown variants. we are excited about the science of it but we cannot continue without additional resources. >> how is your institute working with b.a.r.d.a. to accelerate vaccine development vertically with covid-19 vaccines. >> we have had a long-standing collaboration with pardon now for quite a long time. the way that works is we do some fundamental basic research and proof of concept, very often get involved in the preclinical and the early trials. barbara partners with the pharmaceutical companies to do the advanced development of these concepts. it is a partnership that has worked really well. hopefully we will be able to continue that again as these needs for new resources arise. >> dr. gordon, i want to come back to you. you had several questions about mental illness. not surprising, it is a huge issue for americans today. i know that despite the -- researchers like yourself throughout the past 30 years we have seen dramatic increase in mortality, morbidity, and health care costs related to mental illness. that is actually before factoring in the effects of this pandemic and the opioid crisis. on top of it all, diagnosis is very difficult and medications don't always work and can have awful side effects. i know senator blunt asked you about using radx as one possible approach. what are the greatest barriers of accurate diagnosis? >> frankly, one of the greatest barriers of ankara diagnosis, senator, is that our diagnoses are not terribly good. in terms of describing what is actually going on in the brain. we need a better individualized approach, not just diagnosis but we need to be able to make informed clinical decisions in cooperation with our patients. the clinical issue is not really, does the individual have depression, schizophrenia, or bipolar disorder, those diagnoses can be sometimes hard to differentiate and individual patients. the bigger question is, for this patient with depression or think going to benefit most from medication, what kind of medication, or are they going to benefit most from a psycho therapy, why brain stimulation treatment? we have a number of different research projects that are aimed at trying to make the clinical decisions with the aid of technology. with the aid of increased attention to details and the patient's behavior, cognition's, and that approach is going to take advantage of things like big data. we need to create lots and lots of information about well characterized patients. then we need to make careful experiments to try to determine when that information helps us describe that patient better. so, it is really about precision mention -- moving forward on a number of different fronts. grants from academic informations, as i mention before small business grants, these are really paying off. we should see some progress hopefully in the near future. >> i assume it's fair to assume the solving this diagnosis puzzle would really open door for better treatment? >> it would open doors to transforming how we decide, with our patients, what we must use. it would really change psychiatry. right now as a psychiatrist if i want to help someone with depression, our only discussion is what side effects they don't want. we can try to avoid one main occasion or another as opposed to which medication or which treatment i think will work better for them so yeah, it would really transform things. >> thank you. senator blunt? >> thank you chair. doctor, i've been watching the fda decision on how to handle the biogen drug, as well as the cms handling of that. i think that decision is going to have some pretty long term consequences. particularly the cms decision. other companies will be following, biogen has already made some pretty dramatic decisions, based on cms view, that only the people in the trial could benefit from the emergency approval by fda. would you talk a little bit about both of those things first? the fda approval process, what merit do you see an emergency approval process? what concerns do you have, or not have about cms? and deciding that it would only be available to a few people? >> thank you for the question. fda have had their regulatory responsibilities. we do work very closely, particularly on the science involved in the application. as many or all of you may know, the decision by fda, but was called an accelerated approval, based on its ability to clear amyloid from the brain, and brain scans. without compelling evidence, that was the rub. in fact the fda decision required that, the sponsors then conduct a randomized controlled trial to look and determine if there was in fact a critical outcome. the cms said that, for widespread coverage, it would require randomized controlled clinical trial. made the distinction though about the future of such drug. any drug that received an approval based on clinical outcome based on fda decision and judgment, would have brought coverage without requirement for another randomized trial. any of, which was no demonstrated evidence on effectiveness on clinical outcomes, would require that kind of outcome before they went further. again, those are regulatory decisions. >> it sounds like to me the fda decision was really a cms, a decision to continue the trial. that may not have been what's fda thought it was doing. that's with cms decided it was doing. >> fda, again, by requiring, they've accelerated the approval of the randomized trial being carried out. you ask importantly, i think with the impact will be on the study. there are currently three companies. roach, lilli, and biden, which have an ongoing clinical trial of other anti bodies. to emma loyd. they've all received breakthrough designation last year, from the fda. they're all expected to produce their own results in the next few months. above all, i think we all sure hope and optimism, that we will see affective critical outcomes. for nih, i think the implications are clear. we need support. george amyloid, the target, the kind of research that will give definitive answers about clinically important outcomes. that is certainly our part in this consortium. we're talking about accelerated approvals, we're not. during covid, obviously, and a i.d. shepherded both successful vaccines, for the approval process, during the pandemic. i'm concerned, once the pandemic is officially behind us that, both vaccine and their predict research and development will be subjected to normal development processes that, and what we've learned in the last year and a half, may not be, the structure that we should use. would you talk about that a little bit? >> senator, are you referring to the fact that, we should not slow down the acceleration of approval, when we are out of the pandemic phase? >> i'm asking of that, or if there should be some new normal approval process, now that we've had i think two vaccines and 20 treatments developed through those partnerships? >> i'm not sure i understand the question. that's my fault. are you saying that, should we continue the normal standard of approval, which would take much longer than the emergency use authorization? is that the question? i think we should go through the normal approval. if we are in an emergency situation again, we absolutely should use the eua approach. which has fared us a very well. what we get behind us, the outbreak, i think the normal approval process, which is pretty much expedited pretty well by the fda, should continue. >> thank you chairman. >> thank you madam chair. >> did the biden administration ask any of you whether it was safe to rescind title 42? >> we've had no discussions about that. >> what about you doctor fauci? >> i have not. >> about you doctor depends? >> no sir. >> how about you talk to courted. >> now. >> doctor hotez? >> no sir. >> -- >> the biden administration says it's safe. that under the science, it's okay. who does the administration rely on? to say, to suggest the receiving file -- title 42, is in the interest of public safety? >> that was a cdc decision. title 42 is a cdc decision. >> do you agree with doctor fauci? >> >> i think that the immigration policy should be separated from -- >> either want to get you involved in immigration policy. but people are people, physiology is physiology. the susceptibility of the virus has nothing to do with country or immigration status. i'm asking you purely from a public safety standard. is it safe to rescind title 42? >> i think given the level of infection at the time, which is right now, that i think the cdc decision was a reasonable decision. >> does anybody disagree with that? >> do you all agree with that? just to get you on the record. doctor givens? >> i concur with doctor fauci on that. >> dr. gordon. >> i don't have the expertise to concur or not concur. >> doctor hotez. >> i don't have the expertise to weigh in on this. >> doctor volkow. >> i don't have the expertise. >> okay. >> thank you very much. >> thank you chairman murray. i don't have the benefit of knowing what has been asked and answered. i will ask my questions recently, the proposal would initially focus, would've additionally focused on three diseases. cancer, alzheimer's, diabetes. and be housed under nih. congress and nih already invested in the parliament. how can the nih conduct proper oversight, to conduct -- to ensure nih's current, and not being replicated. >> i think those three diseases are meant to be illustrative, and not restrictive. in terms of a larger issue that you raise. as you know, nih does rather extensive portfolio analyses. and the expectation would be, that there will be a cross top. between the new agency, of nih, to avoid, as you put, the potential for duplication. >> this again, for you. and recent national coverage and determination. it supports -- covering drugs for medicare beneficiaries, participating in a randomized controlled trials. i would interpret that to mean that there is a -- four and eight studies for participants qualifying trials, related to any fda alzheimer's disease treatment. is that in assessment, is an accurate assessment? how would you elaborate? >> if i may turn to dr. hotez, who is the expert. >> i think that's a very accurate statement. >> good. that's a good development. >> doctor hotez, should have said yes. let me talk a moment, in the absence of dr. sharp. who should answer my question. the nih 23 budget request suggests, 199 million dollar cut, to the ncaa. 2.9% cut from the current fiscal year. i assume that, that will be explained as, those dollars being picked up in -- what is the rationale for significant funding pivot, at the expense of and see i. >> at the time the budget was prepared, the only baseline that the administration had to work with was to continue the resolution. very fortunate that the congress, provided us with substantially more resources that were in the continuing resolution. we certainly look forward to working with you as the 23 appropriations process -- >> there is room. there's no particular insistence that that is the right ratio between the funding arpa-h, and the normal appropriations process for and cia? >> i think it's more a reflection of, using a baseline that was available. >> well. the 16.9 billion dollar increase for ncai and fy 22, allows and site to increase the funding allocated for the cancer grant. it's one of the reasons we continue to advocate for higher instead funding. it's to improve and says ability to award those competitive cancer grants. in recent years, and so i can only fund about one in eight research grant applications. --ne that was a great concern to him as it is to me. if incite funding is not boosted above these levels, can greater speed be prioritizing expanded? >> it would be very difficult to do that in the absence of additional funding. >> thank you all. >> doctor, the national academy issued -- nih resources of -- much of the work that and does is really extraordinary, but nih doesn't do the best job coordinating or setting priorities or focusing on innovations, or evaluating auto immune research portfolio. the authors findings really echo in earlier 2010 national academy study on women's health research, and to address these problems they recommend the creation of an office of auto immune disease research, within the office of director to facilitate cooperation coordination. given the importance of this research, for communities across the country, it's really critical that nih does the best possible job facilitating it. do you have concerns with establishing this office? >> senator, the report as you know is -- released last week, we're still reviewing the specifics of it. in reviewing the messages, among the things that they suggest that we do, developing agency was for developing a plan, making sure the investments that we make, a line with these plans. coordinate both within and outside the agency, to evaluate, and report to congress. at first glance i feel these are things that we could probably do without the creation of a new office. but, i certainly would be willing to work with you and other members of the committee, going forward as we saw through the specifics of the report, and get a better understanding of the rationale behind the specific recommendation. >> i would like to work more with you on that. i think it is extremely important. i want to make sure we are addressing it in the correct way. i want to talk to you more about that. >> thanks. >> senator blunt? >> i think my last question today started with dr. tailback. one of the things we were most concerned about, eight years ago, was the fact that young researchers were just leaving the field. the pool of money, not only was increasing but was about 22% less in research buying power than it had been. what are we doing right now to keep young researchers in the field, and try to see that they get their first credit and that there is not an obstacle based on numbers, and first trans to getting that second great? why don't you start doc tail back, if anyone wants to talk about which you are doing to keep young researchers engaged, i would be pleased to hear that. we've prioritized funding of full stage investigators, back in 2013 we only supported 600 such individuals. last fiscal year 1513. that has come as a result of the institute and center of leadership, prioritizing applications from these individuals. we have also created certain mechanism that would incentivize and enable early stage investigators. for example, we have the so-called cat early stage investigated award. no preliminary data is accepted. this is important. it basically liberate narrow investigator from his or her post doctoral or graduate school experience. they are able to think as boldly as possible in preparing an application. we also have the nih director innovation award program which is attracting early stage investigators from very broad biomedical fields. when you take these things together i think we are making good progress in ensuring the entry into the system of biomedical research. let me turn to my colleagues and see if anyone else wishes to comment. >> i may add to doctor tabak, there are two areas where the nih is particularly focused in on. as evident in this hearing a critical element is the translation of basic science understanding into clinical science and medicine. clinicians scientists are critical to making those transitional leaps that are so important to public development. this is an area, quite frankly, where there is a -- a critical pipeline we have special award for early state investigators. their first development, in particular to launch their careers as early state critical investigators. i would also add to the diversity of the early stage investigated pool is critical. recognizing the critical efforts to expand that diversity, again, is another high priority. we have program specifically designed to do that. >> anybody else? >> to reinforce the points made and also to track outcomes of our programs including training career development. expanding research around alzheimer's and research, since 2015 to the president fully a third of the investigators awarded have been new in early state investigators who have had no prior major nih research i. think that is an important reflection of our ability to recruit and to bring investigators into the workforce. >> i just wanted to comment, doctor tabak alluded to, it adds a crucial factor. these going after younger kids, teaching them, giving them the opportunity to see what science is all about, that is a way to ensure that you will have them through all the way to being investigators. >> thank you, senator moran. >> i will take this moment to thank you and senator blunt for your leadership and the success that we have had three numerous years in a row in support for the national institute of health. i have been a ranking member of this committee, with senator harper. you both ranking members, chair men and women of this committee during a period of time in which we were capable in a bipartisan way to increase the investment in fighting the diseases and inflections of america for people around the globe suffering through. not knowing when our commitment schedule is in the future we might not have senator blunt here with the nih crew i want take this moment to thank him in particular for his efforts. they have been recognized around the country but certainly in our home state of kansas and missouri, making a tremendous difference in the efforts to find the cures, treatments, to reduce these elections that we face in the world. of our well-being, and our house. to you, but to senator blunt particularly, today, thank you for that leadership. i am pleased that the world is in a better position and americans have a better chance of fighting these diseases. there is a lot more hope than there used to be. >> thank you, thank you for those comments. i think we all agree. that will end our hearing today. i want to thank my fellow committee members for their lawful conversation. i want to thank doctors tabak, slouch-y, gibbons, -- think you for joining us today. for any senators who want to ask additional questions, questions for the record will be due -- until then from members who wish to submit additional materials for the record and for this material, for 1:38 tuesday, may 24th at 10 am for a hearing on the biden administration budget request for the department of education. meeting adjourned. education. [inaudible conversations] [inaudible conversations] [inaudible conversations] next to hearing on the condition and mistreatment of military families and privatized military how thank. this
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