tv Dr. Fauci Others Testify on 2023 NIH Budget CSPAN May 20, 2022 3:28pm-5:05pm EDT
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>> good morning. the senate appropriations subcommittee on labor education and related agencies will please come to order. today we're having a hearing on the biden administration's fiscal year 2023 budget request for the national institute of health. senator blunt and i will each have an opening statement that i will introduce eyewitnesses and after their testimony editors will each have five minutes for a round of questions. while we were unable to have this hearing fully open to the public or media for in person in attendance live video is available on our committee website. if you are in need of accommodations including closed captioning you can reach out to the committee or office of congressional accessibility services . every day across my home state of washington researchers at the fred center university of washington, washington state university 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 secures treatments and hope for the future. discoveries that saves lives. discoveries that don't just drive innovation and economic growth but also bring families cures and treatments and hope for the future. i am pleased to say this budget request shows the administration understands the tremendous importance of supporting our nations aisle medical research community and continuing our tradition of global leadership here. especially in the past years have been such a stark reminder of how the investments we make in research today pay off down the road. the rapid development of safe and effective covid vaccines was made possible by research in the mrna vaccines we funded in response to evil up and other viruses and by a biomedical research enterprise that has been built over decades. and today thanks to the
vaccines and therapeutics at nih research help develop, covid deaths and hospitalizations are the lowest we've seen in twoyears . however we are not out of the woods yet. when it comes to this pandemic there is still the threat of new or deadly variance especially right now when caseloads are inching up again but our communities resources have largely been bent down. we need to defend the hard-won progress we have made and that means passing emergency funding so our communities have the tests and treatments and vaccines and tools they need to keep family safe. this is really urgent so i'm going to keep fighting to make sure we get it done. and in addition to providing our communities the resources 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 that are effective against all variants and understanding long covid and how we support the people living with it and challenges like the mental health crisis this pandemic has made so much worse especially for young people or overdose deaths which have been skyrocketing due to the rise of fentanyl. recently our nation lost a record hundred 7000 people to overdose deaths in a single year. and in washington state your debts increased by two thirds in 2021. this crisis is carrying a hole in so many communities, so many families and it is truly heartbreaking and we have to pull out all the stops to get vendor control. that's what i am working on bipartisan decision to strengthen programs that help
healthcare professionals and others on the front lines. and why i want to make sure we continue investing in research here like this budget proposes. of course the measured success against any disease is not how much we invest to fight it . it's how much we are helping patients. for example when it comes to alzheimer's disease that's 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 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 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 funding for alzheimer's research six full since 2015. when the 20/25 target date was established in the national alzheimer project that is just around the corner when there are so many
other terrible diseases families are desperate for nih to put more resources into as well. another important undertaking is the launch of the advanced research project authority for help which aims to break the mold for how cutting-edge research is conducted, speed up the discovery and development of medical treatments and support projects that have the potential to transform medicine. i've worked hard to provide resources to establish our bipartisan funding bill earlier this year and am working hard right now to pass the prevent pandemic to set it up for long-term success that requires a balance to ensure our age can complement their expertise while still operating independently to nimbly seize opportunitiesto accelerate innovation . i'm really focused on getting that balance right so i'll be asking more about why so much of the nih budget increase requested by the administration goes towards
our age when it has yet to bring on a staff and what that means for the other nih institutes and centers. at the end of the day innovation isn't just driven by new programs and investments, it is driven by people which is why with as much as we invest in nih each year and it's important as the work is to our families we can't afford to have this agencies potential limited or itssuccess threatened by bias discrimination or harassment in the workplace . we have to do more to address harassment in the biomedical research committee as well as address the fax that the number of researchers of color is too low and even clinical trials often fail to be adequately represented. these are real problems with real consequences for research and i've been pressing for progress on this for years. so i've been glad to see nih working to examine barriers to diversity among its researchers address how its practices have reinforced structural biases and
implement a new policy in this committee that requires those that receive nih strength to notify the agency when principal investigator is removed even temporarily for sexual harassment. but more work remains to be done to remove racism and discrimination and harassment from research and i will continue to follow our progress here. finally before i turn it over to senator blunt i want to take a moment to note this will be the last and i each hearing we have 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 iowa who really understands why these investments are so important to families in washington state, misery across the country and it is willing to sit down and work on a bipartisan way to make sure we are delivering our folks back home so thank you and i'll turn it over to you. >> thank you chair. i appreciate the work we've
done together . as you said this is my in all likelihood last nih hearing as i started to look back on the time i spent in the senate one of the things i think we will have the most long-term impact is what we have done together for nih research. you've been a great partner in that effort. we work closely with the chairman and parmesan coal in the house to chair that subcommittee and they have both chair the committee during the eight years we've been doing this work together. the entire committee of course was involved but i particularly would 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 a trajectory that really was not good and of course doctor payback thank you for you and the directors being here with us today and i think all of you would remember when i became chairman eight years ago nih funding was stagnant
andhad been for about a decade .but over the past seven years working together we'veincreased that funding by nearly 50 percent . it was a time that looking back and each no one to sustained funding but also having a substantial net increase every year and i'm hopeful and confident that senator murray's continued partnership and that commitments will let usdo that again this year and i hope we're 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 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 few increases frankly that havebeen proposed in this request . and one like the increase at cures is coincidental and this fy 23 year has that number already built-in. the only significant increase as the chair has pointed out at nih this year would be an increase of $4 billion for our age. i'm a supporter of the secretary's decision to have it associated with nih but for billion-dollar increase for arpa-h and no increase for nih would verify the concerns of it 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 risk, becoming not real partner in targeted research outcomes that have a specific short-term goal in mind and 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 ofwhat we were able to do in the pandemic . i was also surprised that the budget request failed to take more of the lessons learned from the pandemic into consideration instead of embracing more high risk high reward science and focus on projects with instant impact which proved so successful with programs like red x. it appears the budget bogged
down with political priorities that don't quite fit the agencies long-standing mission. this is clearly illustrated with a request for a new center for sexual orientation and gender identity virtually no additional moneyfor the cancer moonshot . nih is clearly in a period of transition. if there's one lesson to be learned from the covid-19 pandemic, it's that our nation's 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 and i hope the original eventual budget that we propose to our colleagues in the senate and the whole congress will reflect that determination to make nih stronger across the board rather than the way
this budget proposal looks at nih. thank you for the chance to speak and for holding this hearing thank you. i will now introduce our witnesses. we have doctor lawrence tailback as the acting director of the national institutes of health, doctor anthony fauci director of the allergy and infectious diseases, gary given is the director of the national heart lung and blood institute. joshua borden is the director of the national institute of mental health and doctor nora walcott is director of the national institute ofdrug abuse . thank you for being here today. acting director take backyou may deliver your opening remarks . >> thank you chair marie, ranking member blunt and subcommittee members. i'm honored to be here with mycolleagues representing the nih . this is the time for nih and the entire biomedical research facility to examine all our efforts during the
covid pandemic we were driven by the urgency of the moment. nih must learn from its 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 the time to reflect on what worked and did not work to address covid and she knew strategies. your sustained investment set the stage for the new mrna technology and design that were key to the development of safe and effective vaccines in an unprecedented timeline. since these vaccines became available it is estimated more than 2 million american lives were saved and 17 million hospitalizations were averted. now we need continued support for a wide range of biomedical fields including the behavioral and social sciences to identify and implement better ways of responding to the short and
long-term health effects of covid-19 to prepare for future pandemics and ensure equitable equitable protection. and it's not just about vaccines. our rapid acceleration of diagnostics fueled the development of many new approaches for testing that are being used in our communities. to help ensure that such benefits were shared with those disproportionately affected by the pandemic we initiated efforts like rad ask and community engagement alliance. these experiences along with other nih led efforts focused on treatment development to 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 for health. thanks to your inclusion with key authorities and the
funding of the omnibus nih is beginning to frame the basic administrative infrastructure for arpa-h. this is a key first step in creating a permanent home for the strategic partnerships urgently needed to address cancer, diabetes, alzheimer's and many other diseases. we can't stop there. and 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 for patients while building trust. we do better science and when we have a diversity of scientists from different backgrounds and communities. scientific fields in various stages. nih continues to prioritize fund and empower early-stage investigators so that they
can succeed as independent researchers. in 2021 we reached an all-time high of early-stage investigators funded 1513. the passionate commitment of our scientists is matched by the voices of people living with a widerange of diseases . conversations with patients and their 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, along covid and many others thesevoices have refused to be ignored and ultimately all of us are better for . this is the moment for renewed focus on the future. we spent a lot of time encouraging early-stage scientists but i'd also like to think about the importance of engaging elementary school age children that goes like those my wife is not for four years. during the 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. but the images they saw were usually older men wholooked like me . hopefully today's kids are seeing more scientists who look like them. so we need to do better. our nation needs all the bright lines we can define and i hope you'll continue to work with the nih to make this happen. thank you for your time and i welcome my questions. >> i realize i was going through the list of panelists but i skipped doctor richard hodes, welcome to you as well. we will now begin around a five minute questions. i asked my colleagues to please keep track of theclock 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 a spike in my home
state of washington by 30 percent and much like the rest of the country were really driven by fentanyl. this is really a national crisis so we got to be using every tool that we have to support our communities including fentanyl strips which secretary becerra mentioned in his hearing here a few weeks ago. the research i've seen indicates that those strips are used to detect fentanyl in drugs are an effective overdose prevention tool but they require several steps to use them including chipping off some of the hill to test it. can you tell us what the research shows about the effectiveness of those test strips and really are the easy to use? can you talk about that? >> thanks for that question and the fentanyl test strips have been tested for specificity and the data shows its high sensitivity and there are only a few fentanyl analogs that are not
detected. having said that the fentanyl test strips were developed for testing in urine so patients that are being monitored are now in a new application and as a result it's how it's implemented. overall patients that have used the fentanyl test strips report positive outcomes and actually in terms of identifying drugs may put them at higher risk. the research is not on going to try to determine what are the optimal guidelines on how to use them number one number two if the results are positive what is the time to engage that base if they still want to consume them. as you know there are still multiple problems in terms of making this fentanyl test strips throughout the united states and there is indirect and actually determining and getting a group out for some of these tests by the fda so they can be utilized in a healthcare setting which is not possible at this moment
are there other overdose prevention strategies you and hhs to rule in the coming months ? talk to me about what we're doing in terms of prevention. >> prevention strategies that have been shown to be widely effective are perhaps one of the most important ones is widespread diffusion of knowledge so that becomes actually a challenge but no luck so is not available for those that use them. another harm reduction process is the extent to which because the drug supply is so extremely dangerous today in which the safe injection site could be viable for patients that otherwise may be at very high risk of overdosing and while the data is still primary in the united states they have shown that in certain settings they can be quite effective so there's interest in evaluating them. there's also interest in the community to test other
products that may serve as harm reduction. forexample the use of , which is sold as t and contains a drug molecule that has the effects of stimulate a dose of bhutan over and which could be utilized for decreasing withdrawal of depression. these are more novel and we don't have sufficient data but those are thingsthat are being discussed . >> doctor, it is said that science is a marathon not a sprint. however congress is investing in research totreat and cure alzheimer's and related dementia was really a sense of urgency . we pour resources into this research. 17 billion since 2015 to supercharge the discovery process with the goal of finding a treatment for cure by 2025 and i'm concerned that nih isn't positioned to meet that deadline. given the sheer scale of federal investments what is
are they doing to deliver outcomes to accept his progress towards finding effective treatment? >> before the critical question. let me answer it briefly in terms of process and then with examples of meaningful accomplishments during this time. as you know we counted on critical inputs from the national global research communities, advocates etc. with our annual summits all of which feed into careful identification and milestones which are necessary to meet our most important needs. i want a moment to thank the staff for the interactions we had to help us focusing these milestones into meaningful quantifiable outcomes and making them transparent and available. some of the examples of that are important advances want to start with our clinical trials. pharmacological trials are currently eight studies picture fees three and their
latest stages identifying positive outcomes, meaningful outcomes which are due over the next year to reveal their answers. there's a 60. early phase clinical trial in a variety of targets, reports of them not amyloid. these are the results of basic science more potential targets so the clinical trials are investment in them are important. you alluded to the burden on families, those living with dementia. that'salso an area of clinical trials . we know funding a large number of trials studying interventions for care and care providing which will be reducing theirresults . the national academy identified two of those iterated with nih funds that are ready for dissemination with further evidence. i'm happy to elaborate as time allows these are some of the examples that have are an important process to continue to be accountable to you and the public for making the best use of these very critical funds.
>> i think transparency is important. we put a lot of money for this and we need to know congress how those investments are going so we look forward to working with you on that as well thank you chair. doctor tabak, during the time you were deputy director of the seven hearings we had that doctor collins who was the director at the time every single time he talked about the importance of nih bringing hope to millions . i want to talk about the proposed ending of funding for the undiagnosed disease network we had one of those , chair murray has one in seattle. i had somebody reach out to me a couple of weeks ago. michelle herndon from missouri was concerned because her son mitchell who
had suffered from a series of health issues that doctors couldn't diagnose benefited from one of the centers. by late high school he was in a wheelchair andhis eyesight was gone. they were losing hope . but after they sought treatment at the undiagnosed disease network in st. louis, they found a neurological condition so rare that it didn't even have a name. in fact 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 what this long struggle had been about.this year's budget cuts the undiagnosed disease network and closes all 10 of its clinical sites. she was concerned about that. i am too. i think there's some
discussion while they may graduate in some way where they continue to exist. i think it would be a problem to walk away from that. not everybody can come to nih in bethesda and if you don't have a site within some reasonable distance of where you are, you're unlikely to get this service. do you want to talk about why the decision was made and stop funding these 12 sites? >> we certainly agree the diagnostic services provided by the undiagnosed disease network are extremely valuable to the patients and their families. the challenge that we face is there does come a point where diagnosis become part of standard care versus a research question. but finding that right now is something that we continue to work through.
all the cases that are enrolled presently will continue to undergo comprehensive evaluation . we will establish a data management and coordinating center to work on the experience of all of these centers that are disputing in this program. but really we 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. we can't have standard care if you are still discovering things that need to be looked at as an option. mitchell syndrome is mitchell syndrome only because he was the first and maybe the only diagnosed person so far that ever had that and that's going to fall outside of standard care definition i think so let's continue to work on that is doctor gordon available?
let me ask him on the red x in the mental health area in the red x example of again, nih itself partnering directly with others to try to find a rapid solution, do you think that that shark tank red x option would be a possibility as you look for biomarkers in mental health? >> i think that's a great idea senator. i appreciate your support of the initiative and nih as well. we funded a number of small businesses as well as a number of academics have come away with biomarkers that can help guide our decision-making, something we desperately need to help speed through treatments and make surepeople who need treatment get the right treatment from the get-go . one of the ideas we've been thinking about is using the
example where you had essentially a competition between a number of different companies and the idea is to apply something like that to the biomarkers space for mental health. and we think now is the right time to do that. so we're talking with our colleagues at the niv veranda competition trying to figure out how we can do that for biomarkers. >> i'd encourage that. i think every single home test for covid-19 comes out of that experience and if you had people that have ideas that can come to you and try to see which of those you should partner with i think that would be a great step in the right direction. thank you chair. >> senator reid. >> doctor gordon, we're in the midst of a significant spike in suicide, particularly among children which is disturbing and we
know that some of that is the result of the pandemic but i'm just interested in what research at nih is pursuing this issue to recognize warning signs. how is that research being operationalized and put out to practitioners particularly to families and then the other point would be we have a new national hotline 988. are you in anyway trying to coordinate or work with them? >> the answer to both of those questions is yes, we are deeply involved in making sure our research and forced practitioners both in the clinic and at the state level when were talking about 988 to talk about suicide first. and nih has funded a different number of different programs and identifying individuals at risk and getting into evidence-based care. one example would be the nih
internal program developed a screening questionnaire called the asq that has been disseminated to primary care practices and pediatric emergency rooms throughout the country. it's being used nationwide. we also have funded a number of research projects looking at school-based identificationand prevention method measures as well and to do our best to make sure they are out there . we also work with federal partners in mental health services and administration and there where working with them especially around the 988 looking to make sure that states that are implementing the follow-ups 2988 are aware of evidence-based approaches to mental health crises. for example with the proper utilization of mobile crisis teams that are trained and responding to individuals within mental health crisis is one evidence-based approach that has been proven over and over again to work. so yes, we continue to work
in both those areas. >> doctor fauci, the issue of long haul covid has been dominating the news lately. can you describe how nih is tracking these cases? are there common elements and are the treatments showingany promise , where are we in this process ? >> thank you for the question . i will begin the answer and handed over to doctor gibbons who is involved with this. as you well know this is a real phenomenon and the epidemiology of it is still being worked out. but there's a range of people anywhere from five percent up to 30 percent of people have a persistence of symptoms that are not thoroughly explainable by any pathogenic process that we've been able to identify. we put together large cohorts that are now being followed both to understand the actual prevalence incidence as well
as pathogenesis. with regard to treatment center it's very difficult to do any treatment for it when you don't know exactly what pathogenic mechanisms are and that's the reason we're putting so much effort into trying to find out just what is going on. is it a new activation, it is it persistence of virus not necessarily replication confident virus but maybe particles of powers such as the nucleotides. let me handed over to doctor gibbons who can talk about that.'s we are indeed setting up researching to advance recovery efforts. it is moving with our sense of urgency given the suffering of the patients with long covid. there are a number of elements that launched very effectively. wants to create electronic health records based set of cohorts. there are derived from the 60 million records of patients
across the country. diverse body of patients of which between four and 5 million have covid and it provides an opportunity to track as individuals electronically and digitally longitudinally to see who develops long covid who does not. conform our understanding of the prevalence as well as the risk factors as well as the long-term effects of chronically. it's all starting to show preliminary evidence that suggests the potentially ability of vaccination to prevent the development of a long covid soap using signals that are telling us that the severity of the acute covid has bearing on your susceptibility to develop it. similarly were seeing trends towards those most affected and it's identifying people
of color, african-americans and latinos as a high prevalence through developing long covid that hasn't come to thefour as much so we're learning as we develop this program . >> just point if i may we have to reauthorize the star act. it's the best thing we've done in a long time and i think you'll agree doctor, just it's a novel decision. >>. >> thank you ma'am chair. doctor, what's the national institutes of health has done and continues to do is nothing short of extraordinary. it's really breathtaking. 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 ask for it or not you've been the governments face on our response to the pandemic. looking back and i recognize that hindsight is crystal-clear but looking back, do you think it was all worth it. do you think the benefits were greater than the costs? of closing down our elementary and secondary schools? >> i think it's difficult to give a definitive answer to that. i know in the very beginning when we had really no other protection prior to
vaccination that were available to contain someone somewhat the spread of the virus one of the things that was felt to be important would be to protect children as well asthe rest of the population . right now we have felt more than just recently that it's very important to keep the children school. for the simple reason that we know of the deleterious effects of psychologically mentally and developmentally children to keep them out of school but you have to have a delicate balance between protecting the children and perhaps bringing them. >> i believe that we have. it's very tough to tell. i think only time will tell whether that's the case because there is indication that has been deleterious effects on children but we believe from a public health standpoint atthe time it was the right decision .
>> can i ask youthis , i realized i'm not seeing or offering judgment on what was done of the time. i'masking what we've learned . suppose we had a substantial increase in the prevalence of the coronavirus next week. god forbid. would cdc recommend shutting down the elementary secondary schools ? >> it's very difficult for me to speak for the cdc. >> would you recommend it? >> right now i would do everything we can to keep the kids in school and not shut down the school and that's always my strong recommendation. not to keep the kids out of school but to keep them safely in school by a common getting children that are available to be vaccinated vaccination. to get the children who are eligible to be boosted vaccinated and to surround
the children with teachers and personnel are vaccinated. that is the best way to protect the children while 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 in shutting down society? would we have been better off saying no, were going to protect the vulnerable. the elderly. people who are immunocompromised. and we're 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.
>> well, it's a collocated question and i'll try to give as simple an answer as possible. i think there's a misperception about who the vulnerable are. there are many many more vulnerable in society there's a misperception. >> i'm 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 and it isn't a question of shutting down completely because we never shut down completely. if you do shut down society you do it for the purpose and the purpose is at period of time when you're 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 aquestion . what would you do differently today?
>> right now i would hope we would get many more people vaccinated . >> but what would you do when you did it in hindsight if you knew thenwhat you know today ? >> it depends on when we got the vaccine. you mean before the availability of vaccines ? or the ability of vaccine when we have no other situation i would like try to protect people by making sure that their mask and they kept themselves separated from this country indoor setting. that's whati would do . in the absence of a vaccine but right now i think it's important looking forward. we still only have 66 percent of the total population vaccinated and less than half of those are boosted. i think we can approach what we're seeing now within increase in surges with the possibility of a surgeon winter.
one of the things we can all do as a nation is pull together and try to get our people vaccinated and those who are eligible to beboosted boosted . that wouldsolve a lot of the problems that you're referring to . >> thank you. >> thank you, senator bowman. >> welcome to doctor tabak. i'm posting the first question to you for an update on research efforts to better spawned to that 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. and an increasingly dangerous role is played by synthetic opioids such as fentanyl as well as psychostimulants like methamphetamines. i believe it's vital that we invest in sustained research
into substance abuse disorders to prevent deaths, treat patients and make our community safer . if you could describe research efforts including what's happening with the heel initiative helping to end addiction long-term. i would appreciate that. >> if i may to turn to doctor folk off as our expert in this field. >> absolutely. >> our research is going from the basics to help develop medications with new targets. developformulations that can be actually need to better outcomes . through epidemiology research to understand the changing face of the overdose crisis. as your mentioning its no longer limited for overdoses on fentanyl, methamphetamine and cocaine to implementation
research that can help determine what are the optimal models of care we can deploy in communities and to take advantage of infrastructure so for example research is ongoing to make sure the healthcare system can be involved in the treatment of substance abuse disorders and how can we bring treatment to justice settings like jails and respond and maximize the feasibility of healthcare to the involvement of communities sothat we can actually integrate the efforts between healthcare justice and communities . the initiative we've been able to accelerate also another area that has been neglected overall which is the need to better treatment for the management of pain and if we do not address the need of patients suffering from severe pain we will keep them as being vulnerable. and finally we also ask ourselves what is in the
united states that is making americans so vulnerable and that is very relevant to prevention because if we do not understand it then we cannot do interventions to actually protect those that because of circumstances, alien to them are actually at much higher risk of taking drugs and developing addiction overdoses. >> doctor fauci, the us was able to bring a vaccine to the public and really record time. and i'm grateful to the work of so many that made it possible including several who are in this room. unfortunately the next pandemic driven by an unknown disease will come. and i believe we can't wait.
we should invest in the development of novel antivirals and 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 federal 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 clearly investment in clinical biomedical research for at least a few decades and maybe more prior to the realization that we're dealing with a new historic pandemic allowed us to do something that was completely unprecedented. two examples of that are the work done on what we call vaccine platforms, the mrna
vaccine which was basic research on how to get the molecule to serve as a platform for a vaccine. work at the nih in our own campus as well as nih funded investigators throughout the world working on what's called image designed to do work that led to the ability to stabilize the optimal immunogen. in this case it was a spike protein which allowed us to go from realization of a new pathogen on january 9 getting into a phase 1 trial in 65 days and 11 month datahaving a safe and effective vaccine . we did that because the investment referring to right now looking forward we had what's called a prototype pandemic preparedness plan which means you do just whati believe your alluding to . you develop a number of families. there are about 20 families that are all that high risk
and of those there are seven families of viruses that if you do the fundamental work of looking at the commonalities among them and develop diagnostic tests and do that now and if you don't get the resources now congress has been very generous up till now but if we don't get the resources we need we are not going to be able to do the kind of preparedness not only for vaccines but also for targeted development of antivirals 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 so fundamental basic and clinical research are the core of everything isgoing to protect us in the future . >> senator braun. >> i'm going to have two questions. and i'd like doctor tailback and doctor fauci to answer each of the two questions. i'm going to start with this
one. in navigating through the entirety of what we did to fight the disease the most expensive feature would have been lockdowns. we did that uncertainty. we had no idea how that was going to work even in the business iran and early desktops for you to get the case and clear out the warehouse. we quickly understood you don't throw caution to the wind and you take the basic information that we all had to deal with and you took it seriously. you took protocols. let's look at lockdowns. cost us trillions of dollars and we're paying for that now with superhigh inflation and i think i'm interested in where johns hopkins comes out with a study that said basically that didn't have any impact on mortality. and i don't know that that study addressed what mortality might have been impacted in terms of differing other healthcare.
can we take lockdowns off the table in terms of what we do in the future? doctor tabak and then doctor fauci. >> i can't say because i don't know what that future holds for us. if you have a pathogen that is very fearless, very infectious. >> just assume it's in the same modality is what we get and now getting through . >> i think the initial presentation of the virus was one that was devastating. it killed a lot of people. >> what about the study johns hopkins did because we're always saying pay attentionto the science . >> i'm not familiar with that study. >> doctor fauci. >> that's a very good question. if you go to lockdown you got to use it temporarily for reasons to prepare you to be able to unlock down and get the public prepared for that. right now looking forward i
don't see the need of lockdown in the future unless something very unusual happens. the reason is that what we need to do is we need to get our population vaccinated and we need to get them boosted. that would completely obviate the need to lock anything down so right now if you ask me the question looking forward to ic even if we do get a new variant, i think the vaccinations that we have had in us enough cross-reactivity and our ability with proper resources to make specificmoves. i don't see lockdown in the future. lockdown is a temporary thing to get you to be able to move quickly to save lives . >> that is good to hear because impacts a moment of uncertainty i don't think we could afford to do it again. i hope the invited administration is listening. i've another question i love the effort on is when we took this and still it down to you either get a vaccine or you lose your job. and thank goodness we did
martial bipartisan support that that didn't make sense. supreme court used that as a cue in terms of what they did to aggregate back. so in the future, will we heed what the supreme court said and that he wouldn't calculate even though don't disagree that vaccines are an important tool along with therapeutics and preventative's. would you push 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 the economy and probably not benefit from a result that would have been measurable. doctor tabak and then doctor fauci. >> as you know vaccination is the single most effective preventative measure and so to the extent the law allows. >> would you recommend we go down that path again down to
100 employees in the business to where you said either get it or you lose your job. >> that's the policy calls her, i don't make those calls . >> doctor fauci. >> it's a policy call and i would hope we would marshal everybody both sides of the iron to get out there and encourage everybody to get vaccinated and if they did we wouldn't even have to address that question. i don't like mandating things. i don't like punishing people for not doing something but i would hope that they would realize if you look at the data and just made an appropriate statement moment ago about following the science. if you look at the data of the differences in vaccinated versus on vaccinated people and hospitalizations and deaths it's striking what it is. as a public health person i would say why to all together to get people vaccinated so we won't have to worry about putting what essentially appears to be and is in fact a penalty if you don't. >> the key to that navigation is pay attention to the data
and science, not the political. >> exactly. >> that you, senator rubio. >> thank you all for being here.doctor tabak let me start with this question. we've recently seen not just the biden administration but bob biden administration and others in the policy realm have been actively promoting and supporting the use of things like puberty blockers in hormonetherapy for young girls and boys . i want to limit my question to minors for what they have turned tender transforming care. that's not an fda approved use of puberty blockers. i don't believe in any people especially in minors so as the and ih is america's medical research agency what work have we done to
determine if this non-fda approved use of these medicines is off label use of these medicines is appropriate for minors seeking tender transforming care. >> and ih funds a small number of observational studies to gather the data on the effects of treatments. that's transgender youth and their parents have chosen and are also a small number of studies that describe the health issues and risks including hiv that are unique to these transgender youth. but all of the research in this space is observational if there's no interventional work. >> my question is one thing is the decision made by an adult. especially given the reversible nature of some of these treatments . isn't there some wisdom and the notion that the board
policymakers out there promoting the off label medications that need to permanent changes that there be some more research done on its impact five, 10, 15, 20 years from now. >> as you know transgender youth are often vulnerable to depression, anxiety and engaging in self harm. so it is important that we examine and evaluate the potential effects of these treatments. researchers are observing longer-term psychological impact of these protocols and so by looking at individuals transgender youth with or without histories of puberty suppression we will be able to better answer the types of questions. >> i guess that's my point is we don't know what the
long-term locations are when we weigh the costs and benefits. the fda hasn't approved this and we have policymakers promoting. we don't want anybody arming themselves but we don't know these policy dishes are being made on the process of observational guidance without any long-term trajectory . doctor fauci i'm running into something. i believe the united states would be the only western country that requires its reasons test negative for covid before they get on an airplane and on the other hand are hearing now that for example that covid policy should be limited because we've reached an area where it's manageable. and we obviously know we have a problem at our southern border where everyday people are entering the country illegally and many are not even being tested and even if they are allowed to stay
under title 42. i can't, i don't understand how to become american citizens if you test positive even with a dead virus that spent in your system for 10 days to contest positive taste after your no longer infected and you can't even affect your own country but if you arrive illegally when you test positive or not if you say the magic word asylum you get to stay in the country and this is a real life in aerial. people test positive, maybe they were sick week ago and they can't afford to continue to pay for hotel rooms till they finally store a negative test. at the time come for us to lift this in your view having been so integral in our response? are we at the point where citizens should be allowed to return to their country without testing negative? >> thank you for the question . i don't have the answer to that. we work with our colleagues to continue to examine the
feasibility of that. the idea of having an immigration issue mixed with a public health issue for the general population i think those probably should be separated. >> except they are interrelated because they both involve groups of people entering the united states one is as an entering illegally the other group are frankly not entering illegally. >> ...
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 therapeutics through the approval process 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]
johnson's secretaries me because they were tasked with transcribing many of those conversations. they were the ones who made sure the conversations were taped as johnson would signal to them through an open door between his office and bears. >> i wonder reported the number people that was assigned to