tv Dr. Fauci Others Testify on 2023 NIH Budget CSPAN May 18, 2022 3:36am-5:12am EDT
good morning. the senate appropriations subcommittee on labor, health and human services education and related agencies will please come to order. today we are having a hearing on the biden administration's fiscal year 2023 budget request for the national health. senator blunt and i will each have an opening statement and i will introduce the witnesses and after the testimony, senators will each have five minutes for a round of questions. while we were not able to have the hearing fully open to the public, live video is available on the website if you are in need of accommodations in including closed captioning you can reach out to the committee or the office of congressional accessibility services. every day across my home state
of washington, researchers at the center university of washington, washington state university, seattle children's hospital and so many other world-class institutions are working around the clock and making groundbreaking discoveries. discoveries that don't just drive innovation and economic growth, but also bring families and hope those that save lives. discoveries that don't just drive innovation and economic growth but also bring cures and treatments and hope for the future. i'm pleased to say the budget request shows the administration understands the tremendous importance of supporting the nation's biomedical research community and continuing our tradition of global leadership here especially in the past few years that have been such a stark reminder of how the investments we make in research today pay off down the road. the rapid development of the
vaccines was made possible by research into mrna vaccines and with response to ebola and other viruses and by the biomedical research enterprise it's been built over decades. thanks to the therapeutics that were helped to 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's still a threat of more deadly variance especially right now when caseloads are inching up the resources are down. we need to defend the progress that we have made and that means passing emergency funding so the communities have the tests and treatments and vaccines and tools they need to keep families safe. this is urgent so i'm going to keep fighting to make sure we get it done and in addition to providing the communities the
resources they need to fight to the pandemic i hope we are able to come together this year as we have so many times in the past to continue providing researchers what they need to help us fight covid-19 and so many other challenges. challenges like developing better tests, making the next generation vaccines that are effective against all variance and understanding the long covid and how we support the millions of people who are living with it and the challenges like the mental health crisis this pandemic has made us so much worse especially for young people or overdose deaths that have been skyrocketing due to the rise of sentinel. recently the nation lost a record 107,000 people to overdose deaths in a single year and in washington state, opioid deaths increased by two thirds in 2021. this crisis is tearing a hole in so many communities and so many families it is truly heartbreaking and we have to
pull out all the stops to get this under control. that's why i'm working on bipartisan legislation to strengthen programs that help the first responders, healthcare professionals and others on the front lines. and i want to make sure we continue investing in research like this budget proposes. of course the measured success against any disease isn't how much we invest to fight it but how much we are helping patients. for example when it comes to alzheimer's disease, that is exactly what we need to be focused on. for patients fighting this disease, the stakes are intensely personal. they are fighting to hold onto cherished memories with loved ones and a feeling of control over their deadly lives -- daily lives and that falls on family members, friends and caregivers with still much at stake in their lives the families deserve to know the research projects they are depending on are being thoughtfully designed and prioritized for meaningful outcomes and results.
this is important for me especially when we've increased to six fold since 2015. when the 2025 target date that is established in the national alzheimer project act is just around the corner and when there are so many other terrible diseases families are desperate for nih to put more resources into as well. another important undertaking as the launch of the advanced research projects authority for help which aims to break the mold of how cutting-edge research is conducted, speed up the dead delivery of treatments and support projects that have the potential to transform medicine. i work hard to provide resources to establish the bipartisan funding bill earlier this year and i'm hopeful we can pass the present pandemic act to set it up for long-term success. that requires striking a balance to ensure it can complement nih expertise while still operating
independently to seize the opportunity to accelerate innovation and breakthroughs. i'm focused on getting that balance right so i will be asking more about why so much of the nih budget increase requested by the administration goes towards our about age when it's yet to bring on a staff and what that means for the other institutes and centers. of course at the end of the day, innovation isn't just driven by new programs and investments. it's driven by people, which is why as much as we invest in nih and as important as the work is to the families we can't afford to have this agencies potential limited or success threatened by a 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 fact that the number of research of color is too low
and clinical trials often fail to be adequately represented. these are real problems with real consequences for research and impressing for progress on this for years. so i'm glad to see they are working to examine the barriers to diversity among the researchers and addressing how the practices reimbursed the structural biases and discrimination and implement new policies in the committee that requires those that receive nih grants to notify the agency when an investigator is removed even temporarily for harassment or bullying. but more work remains to be done to remove racism, discrimination from research. and i will continue to follow progress here. finally before i turn 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 for all the work with you on this issue over the years. it's been great to have a partner across the aisle who really understands why these investments are so important to
families across the country and is willing to sit down and work in a bipartisan way to make sure we are delivering for folks back home so thank you so much, senator blunt and i will turn it over to you. >> thank you, chair. i appreciate the work we've done together. as you said that this is in all likelihood my last nih hearing as i started to look back on the time i've spent in the senate, one of the things i think we'll have the most long term impact is what we've done together for nih research. you've been a great partner in that effort. we worked closely with the chair and congressman: the house who chaired the subcommittee and they both chaired the committee during the eight years we've been doing this work together. the entire committee of course was involved but i particularly like to mention senator durbin and former senator alexander who were right there at the beginning of trying to see what
we could do to change the trajectory that wasn't good and thank you for you and the directors being here with us today and i think all of you would remember when i became chair man nearly eight years ago, nih funding was stagnant and had been for about a decade but over the past seven years working together, we've increased that funding by nearly 50%. it was a period of time that looking back the nih not only could count on sustained funding, but also having a substantial increase every year and i'm hopeful and confident the senator of maria's continued partnership will let us do that again this year and we will be able to work together and have a bill this year. i'm disappointed at this budget request produces 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 like the increase in cures is coincidental and this fy 23 number has that built in. the only significant increase as the chair pointed out nih this year would be an increase of $4 million. i am a supporter of the secretary's decision to have it associated within nih, but a
4 billion-dollar increase with no increase for nih would verify the worst concerns that people have had as a competitor to the ongoing research as opposed to finding a way where the government can and should be willing to take on more financial risks to become a real partner in targeted research outcomes that have a specific short-term goal in mind and to help us reach that goal that doesn't mean we should jeopardize research challenges as big as cancer and alzheimer's disease or as small as hearing aids as we look to build frankly on the goal of doing more of what we were able to do in the pandemic. i was also surprised the budget request failed to take more of the lessons learned from the pandemic into consideration
instead of embracing more high rate risk and high reward of science and focusing on projects with instant impact that prove so successful with programs. it appears the budget was bogged down with political priorities that don't quite fit the agency's long-standing mission. this is illustrated with a request for a new center for sexual orientation and gender identity with virtually no additional money for the cancer moonshot. nih is any period of transition. if there's one lesson to be learned from the pandemic, it's that the nations success depends on medical research infrastructure across the country supported by nih. now is not the time to abandon that a goal. now is the fact in time to make it even stronger, and i hope the original or the eventual budget
that we propose to our colleagues in the senate and to the whole congress will reflect that determination to make it stronger across the board rather than the way this budget proposal looks at nih. thank you for your comments and for the chance to speak and for holding this hearing. >> thank you. i will now introduce the witnesses. we have the acting director of the national institutes of health, doctor anthony fauci is the director of the national institute of allergy and infectious diseases, doctor gibbons is the director of the national heart, lungs and blood institute, doctor joshua gordon as the director of the nationall institute of mental health and the director of the national institute on drug abuse. welcome to all of you and thank you for being here today. you may deliver your opening remarks. >> thank you, chair murray,
ranking member blunt and distinguished subcommittee members. i am honored to be here today with my colleagues representing the nih. this is a time for the entire biomedical research community to re-examine all of our efforts. during the pandemic we were driven by the urgency of the moment. nih must learn from this experience and seize the sees te 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 the time to reflect on what works and what did not work to address and shape new strategies. your sustained investment in research set the stage for the new technology and design for the development of safe and effective vaccines in an unprecedented timeline. since they became available, it is estimated 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 the behavioral and social sciences to identify and successfully implement better ways of responding to the short and long-term health effects of covid-19. to prepare for future pandemics and to ensure equitable protection of our diverse population. and it's not just about vaccines. our rapid acceleration of diagnostics fueled the development of many new approaches for the testing that are being used in the communities. to help ensure such benefits are shared with of those disproportionately affected by the pandemic, we initiated efforts under the populations and the community engagement alliance. these experiences along with other nih led efforts focus on covid treatment development and demonstrate the extraordinary
value of public-private partnerships. the nih can build upon the momentum of the covid response and apply it to other challenges through the advanced research project agency for health. thanks to your inclusion of the authorities and the funding omnibus, nih is beginning to frame the basic administrative infrastructure. this is a key first step in creating a permanent home for the strategic partnerships that are so urgently needed to address cancer, diabetes, alzheimer's and many other diseases. but we can't stop there. in addition to new strategies, biomedical research needs new voices. a growing body of evidence demonstrates that inclusion of diverse perspectives yields better outcomes and the clinical setting medical teams provide diverse medical teams provide more accurate diagnoses and improved health while building
trust. with the diversity of scientists from different backgrounds and communities, scientific fields and various career stages. nih continues to prioritize and fund and in power early-stage investigators so they can succeed as independent researchers. in 2021, the high investigation of 1513. the passion and commitment of the scientists is matched by the voices of the people living with a wide range of diseases and conditions. conversations with patients and advocates are sometimes difficult but those are often the discussions that teach us the most. from the advocacy groups of the 1980s to today's groups for autism come along covid and many others the voices have refused to be ignored and ultimately all of us benefit. this is a moment for the renewed focus on the future. i spent a lot of time encouraging the early-stage scientists but 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 pandemic, exposure to the importance of science has become a big part of many of their lives. past pandemics of inspired young people to become scientists but the images they solve are usually of older men who looked pretty much like me. hopefully today's kids are seeing more scientists who look like them. so we need to do better. the nation needs all the bright minds we can find and i hope you will continue to work with the nih to make this happen. thank you for your time and my colleagues and i welcome your questions. >> thank you and i realized as i was going through the list of panelists in front of us i skipped the director of national institute on health and aging. welcome to you as well. we will begin a round of five-minute questions and i ask my colleagues to please keep
track of the clock and stay within your five minutes. i want to start with you. as i mentioned in my opening remarks across the country overdose deaths continue to rise dramatically. last year they spiked in my home state of washington by 30% and much like the rest of the country, they were driven by fentanyl. this is a national crisis, so we've got to be using every tool that we have to support our communities including fentanyl strips, which secretary becerra mentioned at the hearing a few weeks ago. the research i've seen indicates that those strips that are used to detect fentanyl and drugs are an effective overdose prevention tool but requires several steps to use them including chipping off some of the pill to be able to test it. can you tell us what the research shows about the effectiveness of those test strips and are they easy to use? can you talk a little about
that? >> thanks for the question. indeed the fentanyl test strips have specificity and the data shows high sensitivity and others only a few fentanyl analogs that are not detected. having said that, the test strips were developed for testing with drug use in urine so patients that are being monitored. so this is a new application and as a result of that there can be problems with how it is implemented. overall, patients that have used the fentanyl test strips report positive outcomes and in terms of identifying drugs that may put them at higher risk. research is now on going to try to determine what are the optimal guidelines on how to use them, number one but number two, if the results were positive what is it they do if they still want to consume them. as you know there are still multiple problems in terms of
making the tests available throughout the united states and there is interest on determining and getting approval by the food and drug administration so they can be utilized in healthcare settings which isn't possible at this moment. >> or their other overdose prevention strategies that you hope to rule out in the coming months? talk to me a little bit about what we are doing in terms of prevention. >> prevention strategies that have shown to be widely effective is perhaps one of the most important ones is widespread distribution of moloch's own and that in some instances is a challenge that it isn't available. another harm reduction practice that generated a lot of attention is the extent to which because the drug supply is so extremely dangerous these days and a safe injection sites could be viable for patients that otherwise may be at high risk of overdosing and while the data is
still preliminary in the united states, and other countries they have shown that in certain settings they can be quite effective so there is interest on evaluating them. there's also interest in the community is to test other products that may serve for example it contains a molecule that has the effects that could be utilized also for decreasing withdrawal and depression. these are more novel and we don't have sufficient data but those are things that are being discussed. >> it is said that science is a marathon, not a sprint, however congress has approached investing and research to treat and cure alzheimer's disease and related dementia with a sense of urgency. we have poured resources into this research, 17 billion since
2015 to supercharge the discovery process with a goal of finding a treatment or cure by 2025 and i'm concerned that we are not in the position to meet that deadline. given the scale of the investment, what is nih doing to deliver meaningful and measurable outcomes that are towards finding effective treatments? >> thank you for that question and let me answer briefly in terms of the examples of meaningful accomplishments in this time. as you know, we have counted on critical input from the national and global research communities et cetera out the annual summits all of which feed into the careful identification of milestones that is the goal the end of the target to meet the most important needs. i want to take a moment to thank the staff of the committee for the interactions we've had over the past year to help us focus on these milestones into meaningful quantifiable outcomes and making them transparent and
available. some of the examples of the important advances i would point out starting with clinical trials so for example pharmacological trials targeting the latest stage identifying the definitive positive outcomes into meaningful outcomes clinically over the next years there's some 62 early phase clinical trials and a variety of targets three fourths of them these are the results of basic science that has found more and more potential targets so the clinical trials are clinically important and you alluded to the burden on the families of those living with dementia that's also an area of clinical research into trials we now are funding a large number of trials studying intervention for care and care providing which will be producing better results into the national academy ready for the dissemination with further evidence.
happy to elaborate as time allows but these are some of the examples and accomplishments and a process to continue being accountable to ourselves and to you and the public for making use of these critical funds to accomplish the highest priorities. >> i think transparency is important. the deadline is around the corner and we've put out a lot of money for this and need to know if congress how those investments are and we look forward to working with you on that as well. >> thank you, chair. doctor, during the time you were deputy director of the seven hearings we had with doctor collins who is the director at the time 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 network. we have one of those in
st. louis and chair marie has one in seattle. i had to somebody reach out to me a couple of weeks ago from missouri. she was concerned because her son who suffered from a series of health issues the doctor couldn't diagnose in fact my late -- by late high school he was in a wheelchair, his hearing and eyesight was gone. they were losing hope but after they sought treatment of the undiagnosed disease network in st. louis they found a condition so rare that it didn't even have a name in fact he lost his battle. the condition now carries the name the mitchell syndrome. about michelle and her family were comforted by the fact they finally knew what this long
struggle had been about. the budget cuts the undiagnosed disease network and all 12 of the clinical sites. she was concerned about that and i am. there is discussion they may graduate in some way they continue to exist. i think it would be a problem to walk away from that. not everybody can come to nih in bethesda. if you don't have the site within a reasonable distance of where you are, you are unlikely to get the service. can you talk about why the decision was made to stop funding these 12 sites? >> we agree the diagnostic services provided by the undiagnosed disease network are extremely valuable to patients and their families.
the challenge we face is there does come a point where the diagnoses become a part of standard care versus a research question but finding that right balance is something that we continue to work through. all the cases that are enrolled presently will continue to undergo the comprehensive evaluation. we will establish a data management coordinating center to draw upon the experience of all of the centers that are participating in the program but 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 that need to be looked at as an
option. he was the first end may be the only undiagnosed person so far that ever had that and that's going to fall outside of the standard care definition i think so let's continue to work on that. is doctor gordon available? let me ask him in the mental health area in the example of partnering directly with others to try to find a rabbit a solution, do you think that shark tank kind of option would be the ability -- possibility? >> that is a great possibility. i appreciate your support of that initiative. we've funded a number of small businesses as well as a number of academics who've come up with
really wonderful ideas for biomarkers to guide the clinical decision making something that we need to speed up the treatments and make sure the people who need treatment get the right treatment from the get-go and one of the ideas we've been thinking about is using the example where you had essentially the competition between a number of different companies but the idea is to apply something like that for mental health and we think now is the right time to do that so we are talking with our colleagues who ran the competition to figure out how we can do that for the biomarkers. >> i would encourage that. i think everything single home test for covid comes out of the experience and again if you have people that have ideas that can come to you and see which of those you should partner with i think that would be a great step
in the right direction. >> senator reid. >> thank you madam chair. doctor gordon, we are in the midst of a significant spike in suicides particularly among children which is very disturbing and we know some of that is a result of the pandemic but i'm just interested in what research is being done to recognize warning signs and how is that research being operationalized and put out to practitioners particularly and to families and the other point would be we have a new national hotline, 988 -- are you trying to coordinate or work with that or study that? >> the answer to both of the questions is yes we are deeply involved in making sure the research informs practitioners both in the clinic and at the state level when we talk about 988.
talking about youth suicide first, we funded a number of research programs and identified individuals at risk particularly the young and in getting the evidence-based care. one quick example, the program developed a screening questionnaire that has been disseminated to primary care practices and pediatric emergency rooms throughout the country and it's being used nationwide. we also have funded a number of research projects looking at school-based identification prevention measures as well and we do our best to make sure that they are out there. we also work with federal partners like the substance abuse and mental health administration and there we are working with them especially around 988 to try to make sure states that are implementing follow-ups are aware of evidence-based approaches to mental health crises. for example the department
trained in responding to individuals and mental health crises is one evidence-based approach that has been proven over and again to work so yes and we continue to work in both of those areas. thank you. >> thank you, doctor gordon. the issue of the long haul covid has been dying in the news recently. can you describe how nih is tracking the cases? are there common elements and are there treatments showing any promise? where are we in the process of tackling this? >> thank you for the question. senator i will begin the answer and then i will hand it over to doctor givens who is also involved in this. this is a real phenomenon and the epidemiology of it is still being worked out within the range of people anywhere from 5% up to 30% of people that have
the persistence of symptoms that are not thoroughly explainable by any pathogenic process we've been able to identify. we put together large cohorts that are now being followed both to understand the actual prevalence as well as the pathogens with regards to treatment, senator, it is very difficult to do any treatment for it when you don't know exactly what the pathogen mechanisms are and that is why we are putting so much effort into finding out what is going on. is it immune activation, is it persistence of the virus not necessarily replication but maybe a particle of the virus such as the nucleotide but let me hand over to doctor gibbons who can also tell you a bit about that. >> i would add to doctor fauci's comment that we are indeed setting up the research to enhance recovery efforts. it is moving with a great sense of urgency given the suffering
of the patients with long covid. there is a number of elements that have launched effectively. one is to create electronic health records with a base set of cohorts derived from 60 million records across the country. a diverse body of patients which between four to 5 million have covid and that provides an opportunity to track those individuals electronically and digitally and longitudinally to see who develops long covid and who does not and that could inform us doctor fauci mentioned the understanding of the prevalence as well as the risk factors and the long term affects chronically. it's already starting to show preliminary evidence that suggests potentially the ability of vaccination to prevent the development of long covid and a similarly we are seeing signals
that are telling us the severity on the susceptibility to develop long covid and we are seeing trends towards who is most impacted and towards identifying people of color, african-americans, latinos as a high prevalent group developing long covid that hasn't come to the floor as much so we are learning as we go into the program. >> we have two reauthorized the act. it's the best thing we've done in a long time. i think you would agree. just nod your head if sufficient. >> yes. >> senator kennedy. >> thank you madam chair.
the national institutes of health has done and continues to do is nothing short of extraordinary. it's really breathtaking and i want to thank you and your colleagues for doing that. we've all been to pandemic school for the last several years and i want to use the few minutes i have to explore what we have learned. doctor fauci, whether you asked for it or not you've sort of been the governments face on the response to the pandemic. looking back, and i recognize that in hindsight it's crystal clear but 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 is difficult to give a definitive answer to that. i know in the very beginning when we had a 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 felt more than just recently that it's important to keep the children in school for the simple reason that we know of the deleterious effects both psychologically, mentally but you have to have a delicate balance between protecting the children from getting infected and perhaps -- >> should we strike a proper balance. >> i believe that we have. it is very tough to tell.
i think only time will tell whether that is the case because there is indication that has been deleterious effects on children, but we believe from a public health standpoint that at the time it was the right decision. >> i'm not offering judgment of what was done at the time. let's suppose we have a substantial increase in prevalence of the virus next week, god forbid. would the cdc recommend shutting down the elementary and secondary schools? >> it's very difficult for me to speak for the cdc but knowing the fact that it -- >> would you recommend it? >> i would do everything we can to keep the children in school and not shut down the school. that's always been my strong recommendation to the extent possible not to keep the children out of school, but to
keep them safely in the school by getting children that are available to be vaccinated vaccinated, to get the children that 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 it then, did we do the right thing in the shutting down society? would we have been better off saying no, we are going to protect the vulnerable, the elderly, the people that 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 while at the same time providing them guidance about how to protect themselves? >> it's a complicated question i will try to get as simple and answer as possible. i think there is a misperception about who the vulnerable are. there are many more vulnerable in society and there is a misperception -- >> i'm about to run out of time. let's assume we can agree on a definition. >> i don't think we can. society is very heterogeneous and it isn't a question of shutting down completely, senator, because we never shut down completely. if you do shut down a society you do it for a purpose, and the purpose is at that period of time when you're protecting people from interaction that you
get as many people vaccinated as you possibly can. let me ask one last question. what would you do differently today? >> right now i would hope that we would get many more people vaccinated. >> about 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 before the availability of the vaccine? before the availability when we had no other situation, i would try to protect people by making sure that they masked and kept themselves separated from this setting in the absence of a vaccine but right now i think it's important looking forward we still have only 66% of the total population vaccinated and less than half of those are
boosted. i think we can approach what we are likely going to be seeing with an increase in the surges and possibility in the fall and winter. one of the things we can all do as a nation is pulled together and try to get people vaccinated into those that are eligible to be boosted. that would solve a lot of the problems you are referring to. >> thank you. senator baldwin. a. >> thank you madam chair. welcome. i'm 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 epidemic continues to ravage communities across wisconsin and across the united
states and at an increasingly dangerous roles played by synthetic opioids such as fentanyl as well as psychostimulants like methamphetamine. so i believe it is vital that we invest in sustained research and substance use disorders to prevent deaths, treat patients and make the communities safer. if you could describe recent research efforts including what's happening with the heel initiative the helping to end addiction long-term initiative. i would appreciate that. >> if i may refer to the expert on the field. >> absolutely. >> thank you for the question. the research is actually going from the basic to help develop medications with new targets to help develop that can lead to better outcomes and epidemiological research to understand the overdose crisis
that now as you are mentioning is no longer just limited by the overdose but overdoses on fentanyl and cocaine to the implementation research that can help us determine the optimal care we can deploy in the communities and to take advantage of infrastructure so for example research is ongoing to determine how the healthcare system ten can be involved in the treatment disorders and to help them we bring treatments to the settings vulnerable to
seeking out more dangerous drugs in the market and finally, we need to also ask ourselves what is it that the united states is picking america so vulnerable to the use of these drugs and that is relevant because if we do not understand it then we cannot do interventions to protect those and ultimately to develop addiction or overdose. >> the u.s. was able to bring a vaccine to the public in record time and i'm grateful including the several that are in this
room. the next pandemic driven by an unknown disease and i believe we can't wait. we should invest in the development of novel antiviral vaccines and diagnostics for unknown threats from priority viral families now so that we are better prepared in the future. can you explain how the investments we've made over time at nih and across the government made the vaccines and countermeasures possible and how would sustained investments to develop responses to -- >> it's clear that the investment for at least a few
decades and maybe more allowed us to do something that was completely unprecedented. two examples of that are the work on what we did called vaccine platforms that was fundamental basic research. work at the nih worked on the design to do work that led to the ability to stabilize the optimal in this case it was a slight protein that allowed us to go from the realization of a new pathogen january 9th getting into the phase one trial. we did that because of the investment right now looking forward we have the prototype
pandemic preparedness plan that means you do what i believe you are eluding to. you develop a number of families there's about 20 families that are the high risk of those that are about seven that if you do the fundamental work of looking at the commonalities among them and develop the diagnostic tests and if we don't get the resources now, congress has been generous but if we don't get the resources we need, we are not going to be able to do the kind of preparedness for the targeted development of antivirals which we did so successfully but at the core of everything that is going to protect us in the future. thank you.
>> thank you, madam chair. i have two questions and i would like you to answer the two questions. i will start with this one. navigating through the entirety clearly the most expensive feature of the navigation would have been lockdowns. we did that out of uncertainty and we had no idea how that was going to work even in the business i ran we had dust ups that would clear out a warehouse. we clearly understood you do not throw caution to the wind and you take the basic information that we all had to deal with and you took it seriously and put protocols in. let's look at lockdowns. it cost trillions of dollars and we are paying for that now with super high inflation. when johns hopkins comes out
with a study that says basically that didn't have any impact on mortality and i don't know that it addressed what mortality might have been in terms of differing other healthcare, can we take lockdowns off the table in terms of what we do in the future? >> i can't say because i don't know what that future holds for us. if you have a pathogen that is virulent and infectious. >> let's assume it is in the same modality that we've been navigating through the last couple of years. >> i think the initial presentation is one that was devastating and killed a lot of people right now looking
forward, i don't see the need of lockdown in the future unless something very unusual happens. right now if you asked me the question looking forward to do i see even if we do get a new variant, i think the vaccinations we have across the activity and the ability with proper resources to make specific boosts, i don't see lockdown in the future. it is a temporary thing to get you to be able to move quickly to save lives. >> that is good to hear because in that kind of moment of uncertainty i don't think we could afford to do it again.
i hope the biden administration is listening to that. another question i led the effort on. they said that didn't make sense in terms of what they did to aggregate that. so, in the future will we heed what the supreme court said and that you wouldn't calculate even though you don't disagree but vaccines are an important tool and preventative what you pushed to do the same thing that we almost did that would have been the second calamity to occur in terms of what it would have cost to the economy and not benefit from the result that would have been measurable?
>> as you know the vaccination is the single most effective preventive measure so to the extent the law allows if you would want to continue -- >> what would you recommend we go down that path again to 100 employees that say you lose it or lose your job. >> both sides to get out there and encourage everyone to get vaccinated and if they did we wouldn't even have to address that question. i don't like mandating things or punishing people from not doing something that i would hope they would realize if you look at the data and make inappropriate statement about following the science if you look at the data of the differences of unvaccinated versus vaccinated, it's striking so as a public
health person i would say why don't we all pull together to get people vaccinated. we won't have to worry about essentially putting what appears to be and is in fact a penalty if you don't. and i think the key to that navigation is to pay attention to the data and the science. >> thank you. let me start with this question. in the policy realm effectively promoting and supporting i want to sort of limit my question to minors for what they have termed gender transforming care.
that's not an fda approved use of puberty blockers and hormone therapy. i don't believe especially in minors. so, as the nih's americas nih is medical research agency, bloodwork have we done at nih, what has been done to determine if this use of these medicines, the off label use is appropriate for minors seeking gender transforming care? >> they fund a small number of observational studies to gather the data on the effects of treatments that the transgender youth and their parents have chosen. and there's also a small number of studies that describe the health issues and risks. all of the research in this space is observational.
we don't do interventional -- >> one thing a decision made by an adult and especially given the irreversible nature of some of the treatments isn't there some wisdom in the notion that there would be some more research done on the impact? >> as you know transgender youth are more vulnerable to depression and anxiety and engaging in self harm so it's important that we examine and evaluate the potential effects of the treatments. researchers are observing longer-term psychological
impacts so by looking with and without, we will be able to better answer the type of questions you are posing. >> that is my point is we don't know what the long-term modifications are with the costs and benefits. the fda hasn't approved this and now we have policies promoting this. clearly we don't want anybody harming themselves with things of this nature but we don't know the policy decisions are being made on the basis of the observational gardens into your own admission without any long-term trajectory on its impact. doctor fauci, i'm writing i believe the united states is the only major western country that now requires its citizens to test negative before they can get on a plane and into the country and on the other hand for example title 42 which is the covid era of policy should be looked at because we have reached the point now it is
manageable and we no longer need to title 42 and we have a problem in our southern border where everyday people are entering the country illegally and even if they are they are being allowed to stay under title 42. i can't -- i don't understand how do we tell american citizens if you test positive, you can test after you are no longer infectious and you can't enter your own country but if you arrive illegal whether you test positive or not you get to stay in the country and this is a real-life scenario. i know people that test positive and they can't afford to pay for hotel rooms and stay overseas until they can get a negative test. as the time comes for arrest to list having been so integral in the covid response re: at the point citizens should be able to
return to the country without testing negative? >> thank you for the question. it's important. i don't have the answer. we work with our colleagues to continue to examine the feasibility and desirability of that. i think the idea of having the immigration issue mixed with a public health issue for the general population those probably should be separated. >> they both involve groups of people entering the united states. one is citizens entering legally end of the other is people that are not entering legally. the group that is not even if they test positive get to stay and the american citizen can't reenter their own country until they produce a negative and my point is have we reached the point we no longer need to title 42 why do we still need to travel restrictions for citizens
that's the genesis of the question and it sort of seems to be at odds. >> thank you. doctor fauci, you talked a little about this, but i wanted to go back to it again. i'm pushing for congress to pass additional emergency funding to make sure the communities have the tests and treatments and vaccines they need to keep their families safe and i understand your institute is supporting research on the development of these next generation vaccines that could protect against multiple variants. what can you tell us about the progress of that research and what does 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 a broad term is to get a vaccine that
works against multiple variance as a first step. that would be something you get a vaccine that either is directed against the common component against the variance or has each of the components for example in a nanoparticles or multiple components to it. we have studies that right now have gone from preclinical into a human study and the results look very promising. the next step would be to get a vaccine that not only is against all variance but against all of those groups of variance including the viruses that overlap with those we see in many bats that almost certainly are the original source of the viruses that have jumped. the work is going along very well. we are getting a number of
investigators both people established in the field and new investigators, but we can't continue without additional resources and that's one of the things that is very difficult for us because the scientific opportunity is there and we feel we do have this not only as an aspirational goal but we will be able to get to that goal of getting a vaccine that would protect us against both known and unknown variance, so we are excited about the science that we can't continue without additional resources. >> and how was the institute working to accelerate innovation in the next generation vaccine development particularly for covid-19 vaccines? >> we've had a long-standing collaboration and partnership for quite along period of time and the way that works is we do the fundamental basic research and proof of concept and very often get involved not only in the preclinical but the early trials where they partner with a
pharmaceutical company to do the advanced development of the concepts so it's a partnership that has worked very well and hopefully will be able to continue that again with the need for new resources. >> i want to come back to you where you had several questions about mental illness not surprising it's a huge issue for america today and i know that despite the best efforts of research like yourself in the past 30 years we've seen dramatic increases in mortality, morbidity and healthcare costs related to mental illness and that is actually before factoring in the effect of the pandemic and opioid crisis and on top of it all, the diagnosis is difficult and medications don't always work and can have awful side effects. so i know senator blunt asked about this one possible approach but what are the greatest barriers to the accurate diagnosis?
>> frankly one of the greatest barriers is they are not terribly good in terms of describing what's going on in the brain so we need a better individualized approach not just to diagnose but to be able to make informed clinical decisions in cooperation with our patients. the clinical issue isn't does this individual have depression or schizophrenia or bipolar disorder although those diagnoses can be sometimes hard to differentiate in individual patients, the bigger clinical question is for this patient with depression are they going to benefit most from a medication and which type of medication, or are they going to benefit most from psychotherapy or brain stimulation treatment. we have a number of different projects aimed at trying to make this kind of clinical decisions with the aid of technology, with the aid of increased attention
to details and the patient's behaviors and cognitions. and that approach i think is going to take advantage of things like big data so we need to collect lots of information about the character list patients and then we need to make careful experiments to try to determine when that information helps us to describe that patient abettors weights about precision medicine moving it forward in a number of different fronts with grants to academic organizations and as i mentioned also be for small business grants that are really paying off so we should see some progress in the future. >> it's fair to assume solving this diagnosis will open doors for better treatment? >> it would open doors to transform how we decide what treatments to use. with change psychiatry. right now as a psychiatrist if i want to help someone with
depression our only discussion is which side effects they don't want to so we try to avoid one medication or another as opposed to which medication or treatment so it would really transform things. >> thank you. i've been watching the fda decisions on the drug as well as the cms handling. i think the decision is going to have some pretty long-term consequences particularly the cms decision and other companies will be following based on the view that only the people in the trial could benefit from the emergency approval.
what merit do you see in that emergency approval process and what concerns do you have or not have about cms van deciding that it would only via available to a few people? >> thank you for the question. of course cms into the regulatory responsibilities we do work very closely particularly on the science and implications, so as many or all of you may know, the decision was accelerated approval based on its ability to clear from the brain scans the decision required the sponsors conduct the trial and it was in that setting that aside for widespread coverage would require randomized controlled
clinical trials based on clinical outcome would have broad coverage but if there was no demonstrated evidence of effectiveness on clinical outcomes would require that kind of outcome before they went further. again those are regulatory decisions, so it sounds to me it was to continue the trial. >> by requiring the accelerated approval was saying there needed to be a continuation.
the ongoing clinical trials of other antibodies received breakthrough designation and they are expected to produce the results in the next few months. so above all we share hope and optimism for nih the implications are clear we need to support the most rigorous research for other targets, the kind that will give clear-cut definitive answers about the clinically important outcomes and that is certainly our part in this consortium. >> well we are talking about the accelerated approvals were not, during covid, obviously they shepherded the successful vaccines and therapeuticsugh ths during the pandemic. i am concerned that once the
pandemic is behind us both vaccine and therapeutic research and development will be subjected to normal development processes and what we've learned in the last year and a half may not be the structure that we should use. are you referring to the fact that we shouldn't slow down the acceleration of approvals when we are out of the pandemic phase? >> i am asking that or if there should be some normal process now that we have two vaccines and 20 treatments developed through those partnerships. >> i'm not sure i understand the question. are you saying should we continue the normal standard of
approval, which would take much longer they in the emergency use authorization is that the question? >> i think we should go through the normal approval and if we are at an emergency situation again, we absolutely should use the approach which is fair but when we get behind us, the normal approval process that is pretty much expedited pretty well by the fda should continue. >> thank you, chairman. >> senator to me. >> toomey. >> thank you, madam chair. did the administration ask either of you whether it was safe to resend title 42? >> we have had no discussions about that.
>> how about you, doctor gibbons? >> no, sir. >> the administration says that it's safe that under the science it's okay. who does the administration rely on to suggest rescinding title 42 is in the interest of public safety? >> there was a cdc decision. do you agree with it? >> it should be separated --
>> it's nothing to do with their country of origin or immigration status. what i am asking you purely from a public safety standpoint, is it safe to resend title 42? >> i think given the level of infection at the time that is right now i think the cdc decision was a reasonable decision. >> does anybody disagree with that? >> do you all agree with that? i concur on that. >> i don't have the expertise to conquer or not. >> i would also say i don't have expertise to weigh in on this.
>> i do not have the expertise. >> thank you very much. >> thank you, chairman murray. i don't have the benefit of knowing what's been asked and answered so i will ask my questions. the proposal would focus on three diseases, cancer, alzheimer's and diabetes and will be housed under nih. congress and nih invest how can they conduct proper oversight to ensure that its current but isn't being replicated? >> i think they are meant to be
illustrative and are not restrictive in terms of the larger issues that you raised as you know nih does a rather extensive portfolio analysis into the expectation would be that there would be a crosstalk between the new agency to avoid the potential of duplication. >> in recent coverage they supported by governing drugs from medicare beneficiaries participating in randomized controlled trials. i would interpret that to mean that there is a path to coverage through nih studies for participants qualifying trials related in the approved alzheimer's disease treatments. is that an assessment or how would you elaborate?
>> let me talk a moment in the absence of who should answer my question. at the nih budget request suggests it $199 million cut to the nci, 2.9% from the current fiscal year. i assume that that would be explained as those dollars being picked up. what is the rationale for the significant funding private at the expense of nci? >> at the time the budget was prepared, the only baseline the administration had to work with was a continuing resolution level. we are fortunate that the congress and all notice provided
a substantially more resource in the continuing resolution. we certainly look forward to working with you as the 23 appropriations process works through. >> so there's no particular insistence that that is the ratio between the funding of one and the normal appropriations process? >> i think it is more than a reflection of using the baseline available at the time. >> the $16.9 billion increase allowed the nci to increase the funding allocated grant. they could only fund about one in eight research grant
applications. could it be expanded? >> it would be difficult to do that in the absence of the funding. >> thank you all. >> last week the national academies issued the autoimmune research portfolio and found much of the work the agency does in the area is extraordinary but it doesn't do the best job coordinating refocusing or evaluating its autoimmune research portfolio. the findings echo and earlier study will be on the they recommended the creation of an
office of autoimmune research to facilitate collaboration and coordination given the importance of the research for communities across the country it is critical that nih does the best possible job facilitating it. do you have concerns for establishing this office? >> the report as you know was released and in reviewing the topline messages among the things they suggested that we do to develop a strategic plan to make sure investments that we make aligned with those plans are to coordinate both within and outside the agency to do reports to the congress at first glance these are things 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 salt through the specifics to
get a better understanding of the rationale behind this recommendation. >> okay i would like to work with you on that. i think it is extremely important and i want to make sure we are addressing it in the appropriate way. senator blunt. >> thank you. i think my last question we will start with anybody that wants to talk about it. one of the things we were most concerned about eight years ago was the fact that young researchers were just leaving the field. not only was it not increasing but it was about 22% less than the research buying power. what are we doing to keep researchers in the field and try to see that they get their first grand and that there is not an obstacle based on numbers to getting the second grant?
if anybody else wants to talk about what you're doing to keep young researchers engaged i would be pleased to hear that. .. >> we have the so-called tax early investigator award where no preliminary data is accepted. it basically liberates a new investigator from his or her postdoctoral graduate school
experience and then they are able to think as boldly as possible in preparing an application. also the nih new innovators award program attracting early-stage investigators from very broad biomedical fields. so when you take these things together we are making good progress to ensure the entrée into the system of biomedical research let me turn to my colleagues. >> there are two areas we were particularly focused on as evident in these hearings are critical element is the translation of basic science understanding into clinical science and medicine.
and clinician scientist are critical to making those transitional leaps that are so important to public health and this is an area quite frankly where early-stage investigators with the pipeline so we have special awards for them to get their first are one in particular to launch their careers as early-stage clinical investigators. i would also add diversity it is critical to recognize the supportive efforts to expand that diversity which we have program specifically designed to do that. >> i had to reinforce the points made including training career and development so with the expanded research around alzheimer's since 2015 through
the present fully one third of the investigators have been early and early-stage investigators know prior major nih research that is the reflection to recruit. >> and pay because of the payback that is crucial so going after them and giving them the opportunity to see what science is all about four investigators spent less take this moment chair on —- chairman for your leadership and the success we had in numerous lead on —- years on support for the nih.
i then the ranking member of this committee with senator harkin you both have been ranking members and chair men and women during a period of time in which we were capable in a bipartisan way of increasing the investment of fighting the diseases for people around the globe separate not knowing the committee schedule into the future this could be the last time we have senator blend here with the nih crew and a take this moment to thank him in particular for his efforts that have been recognized around the country and in the home state the kansas and missouri to make the efforts to find the cures and treatments to reduce the afflictions that we face in the world of the well-being of our health. >> and that americans have a greater chance of fighting
these diseases and there's a lot more hope than there used to be spent thank you for those comments i think we all agree. that will and are hearing. thank you to our committee members for a thoughtful conversation also thank you to the doctors for joining us today to share your expertise. any senators who wish to ask additional questions for the record you may 27 at 5:00 p.m. until then this committee will meet tuesday may 24th at 10:00 o'clock a.m. for a hearing with the budget request for the department of education. [inaudible conversations]