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completely unfiltered. c-span, your unfiltered view of government. up next, a senate appropriations subcommittee hears testimony on the national institutes of health 2025 budget request. during the hearing, n.i.h. director dr. monica bertinoli and others field questions on fentanyl overdoses and maternal care with other topics. this is an hour and 45 minutes.

>> the senate appropriations subcommittee on labor, health, and human services, education and related agencies will please come to order. good morning. today is our fourth hearing on the biden administration's fiscal year 2025 budget request, and i'm happy to welcome dr. bertinoli to testify for the first time in this committee as the director for the national institutes for health. as the granddaughter of a n.i.h. funded doctor myself, i understand the important role biomedical research plays in treating and curing disease and bolstering our economic growth and ensuring america is a global leader in innovation. i know my colleagues here today agree. i'm looking forward to

working in a bipartisan manner again this year to develop a labor h.h.s. bill that can pass the senate, pass the house, and be signed into law by the president. that should be a bill that invests in n.i.h. and the promise of finding life-saving cures and treatments for deadly diseases. but i want to be clear, our ability to do that depends upon agreeing to adequate top line discretionary funding levels, because of house republicans' insistence on cutting funding for domestic programs, last year's labor h.h.s. allocation was more than $2 billion less than in fiscal year 2023. the first such decrease in more than a decade.

with those cuts we found an increase in fiscal 2024. but we should do better. like last year, more than a decade ago, republicans insisted on cutting discretionary funding as the price of raising the debt limit. as a result, back in fiscal year 2011 through fiscal year 2015, funding for the labor h.h.s. bill actually decreased in nominal terms. and as a result, n.i.h. funding also decreased over that same period. starting in fiscal year 2016, congress finally decided overly restricted discretionary caps were stifling critical investments, including n.i.h. congress began modestly increasing domestic spending as a result. from 2016 to fiscal year 2023, funding for labor h.h.s. increased on

average by $7.7 billion annually, a modest 3.3% per year. but that allowed this subcommittee to increase funding for n.i.h. on average by $2.3 billion annually over the same period of time. unfortunately, republicans are now again insisting on cutting funding for domestic programs, including in labor h.h.s. and that's putting consistent meaningful increases for n.i.h. in peril. i'm deeply concerned that that will put us on a path of stagnating funding for n.i.h. just like what happened last time as i describeed. almost every senator here today will say they strongly support n.i.h. funding. that's easy. but if that's the case, as we have seen over the last decade, we need a workable top line that

allows for a workable labor h.h.s. allocation. and i hope we can return to the bipartisan consensus of just a few years ago and agree to adequate funding for labor h.h.s. that allows meaningful, consistent increases for n.i.h. alternatively agreeing to the draconian cuts proposed by our house republican colleagues on the other side of the capitol, it would be devastating for biomedical research. it would set back years of progress made towards curing disease and weaken america's competitiveness, particularly against china. and we just can't let that happen. so today, i am happy to welcome director bertagnoli and others to discuss the budget. this budget highlights the need for tipped investments along a wide range of republican priorities and speaks to

the breadth of research you all research as director of the n.i.h. i'm pleased to see the report for biomedical research and innovation to develop better diagnostics, improve treatment and precision care for patients, including targeted investments for research on women's health and in support of the going to cut the cancer death rate by at least 50% over the next 25 years. and at a time when we are seeing the spread of h-5n1 bird flu and the case of another human infection yesterday, it highlights the i am interested to hear from dr. marrazzo about the important work that nyack is funding to detect and monitor this virus so that we can limit its spread. the fiscal year 2025 budget

request includes $49.8 billion in total resources for nih including mandatory cures act funding. an increase of $1.25 billion over fiscal year 2024. i want to point out, however, that most of this increase is to backfill decreased cures act funding that falls under this jurisdiction of the health committee. declining cares act funding combined with difficult discretionary spending caps created a uniquely challenging situation for fiscal year 2024 and will again in fiscal year 2025. outside of those increases in discretionary spending for cares act programs, which i'm happy to see maintained, i am pleased to see increases for cancer research, mental health research, and neuroscience research. and during a time when women's

health and reproductive rights are under attack in this country, i was pleased to see the budget proposes a $76 million increase for the office of research on women's health. but i was surprised to see that the budget does not call for any new resources for alzheimer's disease research. i want to hear more about that and what impact that will have on the progress we've made in alzheimer's disease research from dr. hodes. and i want to hear about how nih is working to address our nation's mental health and substance abuse disorder crises. tragically, overdose deaths remain stubbornly high. in 2022, nearly 108,000 people died of an overdone. in my state, there were 1828 drug overdose deaths in 2022,

surpassing the record set in 2021. of those deaths, 1464 involved opioids. i would like to hear from dr. volkow about how they are working together to bring an end to this crisis. i also want to hear about how nih is investing in the next generation of researchers, particularly in light of new data that reveal a decline in the number of u.s. postdoctoral scholars at nih over the last two years. i want to know how you are supporting early stage investigators, particularly women and those from diverse backgrounds. and finally, i want to hear about nih's ongoing research on long covid. it has been more than three years since congress appropriated -- [applause]

it has been more than three years since congress appropriated $1.2 billion for long covid research and nih has moved slowly to enroll patients and has yet to deliver treatments for this debilitating disease. dr. gibbons, i want to know how you plan to leverage the recover initiative to be more efficient and effective to finally move the needle for millions of americans who continue to suffer. i look forward to your testimony and appreciate all of you being here today. and in a moment, i will turn it over to ranking member capito for her opening remarks. following senator capito's opening statement, we will hear from director bertagnolli, and then senators will have five minutes for a round of questions. sen. capito: thank you for being here. dr. bertagnolli, it is good to see you.

thank you for being here but also congratulations on your fairly nearly new role as nih director. i also want to thank you for coming to west virginia in march to see firsthand the amazing things that we are doing at west virginia university, including seeing the work that the team is doing to combat alzheimer's disease and addiction. as you witnessed, my home state of west virginia is a rural state, with some of the highest rates of health challenges in the country. a partnership with nih is critical for us to make improvements. dr. volkow, who has also visited west virginia, dr. hodes who says he is coming, we just have to get the date, dr. rathmell and dr. marrazzo, and dr. gibbons, thank you for being here to discuss the many important health issues facing our nation. and i said, many of you have visited or will visit, and i'm very grateful for that. this will be a challenging funding year, as chair baldwin lined that out.

for me, biomedical research at nih is a priority for me and has been for this long bicameral bipartisan priorities as well. the budget proposes $49.8 billion in funding for nih including 21st century cures and arpa h. the budget also proposes an additional $1.5 billion in mandatory funding for the cancer moonshot. last year, i was proud that we were at least able to get an increase of $300 million in very tough headwinds in discretionary spending for nih. nih isn't just a great research and biomedical research institution, it's also a driver of economic growth. funding more than $92.89 billion in national economic activity across the nation in 2023. in my small state of west virginia, nih supports 759 jobs and $140.8 million economic impact in 2023 alone. this is in a state we really don't see -- too many don't see

us as one of the areas for medical innovation, but we are proving the nation wrong every day. the nih impacts every american in some way, and i hope again to work in a bipartisan way to fund our joint priorities such as finding cures and treatments for cancer, parkinson's, als, alzheimer's disease, and other conditions that plague americans. as i mentioned, dr. bertagnolli -- i will get it someday, joins me -- with a name like capito that gets mispronounced have to time, you would think i would be better at this. i'm trying. i'm trying. she joined me and witnessed the talented research advancements we are doing in west virginia. much of this has been made possible by the partnerships fostered by nih over the years. researchers throughout our state are making significant contributions to biomedical research in areas ranging from cancer to alzheimer's disease, to substance use disorders.

unfortunately, west virginia continues to rank above the average in new cancer diagnoses and deaths. so i am pleased that the budget devotes increases to finding cures and treatments for cancer. as a lead sponsor of the childhood cancer star act, i look forward to hearing about your priorities and advancements to combat cancer and grow our clinical trial networks, especially among our children. i will continue to prioritize fostering nih collaboration with smaller more rural states. last year we were able to provide a modest increase for the nih idea program. this program provides funding for 23 states, including mine, that historically received very little federal research funding. and i'm proud of the friendship and partnership with nih for his leadership. the idea program and the other nih program has been instrumental for marshall university and other institutions in the state developing world-class research in neuroscience, cancer, stroke,

vision, and addiction science. dr. bertagnolli was able to hear about west virginia clinical and translation science institute's new mobile unit, named maverick, purchased thanks to an nih grant. dr. sally and her team will use this mobile unit to give individuals all over the state -- we know access is the issue in rural states -- the ability to participate in clinical trials for new treatments and is a prime issue of how nih investments can directly affect people. i do want to take a moment, and the chair and i are like-minded, to express my disappointment that the proposed nih budget doesn't devote new resources specifically for alzheimer's disease research at nih. i have seen through closed hands through both of my parents the devastating effects that alzheimer's can have on the family, the patient, and the caregivers.

nearly seven million americans are currently living with alzheimer's in our country. and the national cost of caring for those with alzheimer's and other dementias is estimated to reach $360 billion this year. that is staggering. alzheimer's and dementia-related research must remain a national priority. i would also like to see more attention devoted to substance abuse. the national institute on drug abuse receives only a nominal increase in this budget. dr. volkow has visited my state and has seen firsthand how west virginia is in the crosshairs, and every state is in the crosshairs of opioid and addiction crisis. i would like to add my voice in agreement with the chair on the recovery program for those with long covid. and i know we have many in the audience today. [applause] i know we are dealing with a tough funding situation this year but investments in biomedical research are so important for the future of our country. before i close, i would like to

address dr. bertagnolli on something we learned last week. i want to comment on something that is concerning. for years, the nih's leadership has taken the stance that nih gain of function research wasn't happening with the echo health alliance or the wuhan institute of virology in china. this appears to be false based on the doctor's response to a house committee last week. when asked if nih grant funded gain of function research at wuhan. he answered, quote, "if you are speaking about the generic term, yes, we did.” last year hhs debarred the wuhan institute from receiving federal grants for 10 years and just last week suspended all funding for echo health alliance and plans to debar them too. i think both of those should have probably been done much sooner. nih has a credibility problem here when it comes to gain of function research, and i strongly encourage you and dr.

marrazzo in your new roles to restore strength and research integrity and trust to the nih in this area. thank you very much. i look forward to your testimony. chair baldwin: thank you, senator capito. i will now introduce our witnesses. we have dr. monica bertagnolli, she is the director of the national institutes of health. we have dr. gary gibbons, he is the director of the national heart, lung, and blood institute. dr. richard hodes is the director of the national institute on aging. dr. jeanne marrazzo is the director of the national institute of allergy and infectious diseases. dr. w. kimryn rathmell is the director of the national cancer institute. and dr. nora volkow is the director of the national institute on drug abuse. thank you all for joining us

today, and i look forward to hearing from all of you. we will start with director bertagnolli. you may deliver your opening remarks. dr. bertagnolli: chair baldwin, it is an honor to testify before you today concerning our fiscal year 2025 budget request. let me start by sincerely thanking you for the funding you provided to nih in fiscal year 24. every state received a share of nih investment. each year, nih awards over 60,000 grants, supporting more than 300,000 researchers at more than 2500 institutions. we are proud to contribute to nationwide innovation in biomedical research and to support the next generation of researchers who will meet the challenges of the future. nih is guided by the principle that our work is not finished when we deliver scientific discoveries.

our work is finished when all people are living long and healthy lives. decades of sustained investment in fundamental science are producing exciting results. how can the brain be reprogrammed to relieve anxiety or depression or craving for harmful substances? how can we replace a defective gene, thereby achieving durable remission of a debilitating disease? how do we enlist the specific function of the immune response to eliminate an advanced cancer? our laboratories are delivering answers to these questions and many more. but we still have work to do. families across the country are facing high rates of maternal mortality, struggling to care for those suffering from alzheimer's disease, and losing loved ones to substance use disorders. the 2025 president's budget request support these critical

needs, including the cancer moonshot, brain initiative, women's health research initiative, and funding to promote mental health, to overcome suffering from long covid, and to achieve longer and healthier lives for people with down syndrome. our track record demonstrates that with continued funding and support, nih researchers will deliver progress towards understanding and overcoming these challenges. i call your attention to two overarching concerns. first, many are underrepresented in medical research, especially people who are older, uninsured, belong to minority groups, or live in rural locations. and second, for the wealth of data we now collect, we still lack comprehensive diverse data from the clinical care environment that can power new artificial intelligence approaches to improve health. on behalf of the 27 institutes and centers of nih, i present

two new programs to address these important needs. first, to ensure that research discoveries benefit all who need them, we must partner with people across the entire nation, reaching them even, for instance, if they live in a rural location far from a major academic medical center. to do this, we will enlist primary care clinicians on the front lines to develop ways to overcome health challenges that matter to the communities they serve. care providers practicing in underserved communities will be the main focus, supporting them so that their patients will -- and they -- will contribute to knowledge generation and also benefit from research that allows people to receive better care. next, consider how information technology is changing our world and how much more efficient and inclusive our research would be if we could better collect data to learn from everyone. artificial intelligence and machine learning are revolutionizing what is possible for biomedical research and

clinical care. but to realize the potential of new technologies, we need to invest more in a secure and sustainable data sharing infrastructure by engaging government, industry, and academic partners, we will enable health innovation on a national scale, supporting secure researcher access to data along with advanced analytics and computational power. and we will incorporate what we have learned from projects such as all of us, to obtain people's permission to use their health data for research and deliver results back to them, inviting them to be our true partners in research. these efforts to reach people from all locations and walks of life will accelerate progress and ensure that no one is left out. when we ask people what they need and deliver results that benefit them when we are transparent and clear and respect their wishes, we will earn trust.

so, nih-supported discoveries have benefited all of us and we are poised to do so much more. your continued support of our mission to help all people live longer and healthy lives is crucial. thank you for the opportunity to appear before you today. i look forward to your questions. chair baldwin: thank you, dr. bertagnolli. i am going to kick off a round of questions. i want to begin with dr. marrazzo. more than a decade ago, researchers at the university of wisconsin madison studying avian flu, or h5n1, warned that only a few mutations in the virus would allow it to transfer to mammals. today, h5n1 has infected 51 dairy cattle herds across nine states.

just yesterday, a second human case of h5n1 infection was detected in michigan. fortunately, as far as we know, the virus hasn't spread to my home state of wisconsin, but it has caused concern for dairy farmers in my state and across the country. i recently convened a roundtable with federal and state agency leaders and stakeholders in wisconsin on the current state of the disease and strategies for mitigating its impact on human and animal health. scientists still don't know how the virus is spreading or how long cows remain infectious, and our roughly 100,000 farmworkers are at the highest risk of infection. so dr. marrazzo, tell me about the niaid's tracking of thespread of mutations in the virus and the work you are doing to develop a vaccine against it. dr. marrazzo: thank you for that question, chair baldwin.

this is an incredibly important topic and i do want to acknowledge the great work that our university of wisconsin colleagues have done. in fact, they have been part of one of the networks that i want to tell you about. this is a pathogen that has been on our radar for a long time. because when it does get into human hosts, we have seen a mortality of about 50%. so this is something we really do not want to happen. what we've been doing for more than 10 years is funding a group of investigators called the centers for excellence in influenza research and response, of which your university is one. and what they do is to collect and characterize this virus in wildlife, including migratory birds, which has been a very big source of these viruses. that is important, because, as you mentioned, you need to track the mutations occurring in the wild so that you can be prepared to prepare the vaccines and antivirals that you need if the viruses get into human hosts.

so, really important network that has been doing incredible work. and that has been informing us even before the current outbreak. with regard to the current outbreak the good news is that many of the viruses that they have been identifying are very similar, if not identical, to the case in both humans that we know about. although, the sequencing hasn't been done in the human case we heard about yesterday but we assume it will be the same one. so the good news is that we are really prepared to not only test the current vaccines that we have in the stockpile, but also to really develop specific vaccines. so, i think we are in a very good place. we are also working with some of the other agencies involved in this and are continuing to develop monoclonal antibodies, vaccines, and antiviral drugs, all very much a part of our remit and very much engaged in doing this. chair baldwin: thank you. dr. volkow, while recent cdc data shows a slight decrease from the prior year, overdose deaths still claimed more than

100,000 lives for the third year in a row. these deaths are largely attributable to elicit fentanyl. a study published last week shows the availability of illicit fentanyl continues to skyrocket. 115 million illicit fentanyl pills were seized by law enforcement last year. we can and must do more to stop this epidemic and save lives. i know that this is a bipartisan priority for members of this committee, including senator capito and myself. that's why we provided a $5 million increase for opioid research in the fiscal year 2024 labor hhs bill. so dr. volkow, two years ago hhs launched a coordinated national strategy to prevent overdoses. what can you tell us about the healing community study and what interventions it has found to be most effective at the local

level? dr. volkow: thanks very much for your question and thanks for your interest on this very challenging issue posed by the overdose crisis. the healing community study aimed to actually empower the communities in order to give them the resources and the support necessary for them to respond to the local circumstances in which they find. because we see that the overdose crisis is across the nation and we wanted to learn from this community. so the healing community studies empowers them, allowing them to get the data and to develop interventions that are more likely to be beneficial. as a result of that, we have learned strategies that then can be deployed to other states. because this was done just in four states. and we are now expanding access to data that allows communities to see whether there interventions are making a difference or not. and in the process, we have seen a significant expanded

distribution of naloxone and significant expanded recruitment of people and improvement in the practices for treating a patient with pain properly with opioids when they need it and other treatments. chair baldwin: thank you. senator l. -- senator cap patel -- senator capito. sen. capito: thank you. i will stick with you, dr. volkow. i know that you've seen and are well aware of some of the research that's going on with nih at west virginia university on his use of ultrasound to slow addiction and alzheimer's. i want to talk to dr. hodes about that as well. what kind of promise does that work have with ultrasound to decrease some kinds of cravings? i know there is no one size solution fits all here. that is the difficult part of

what you deal with every single day. what do you see in terms of on the horizon for treatment? dr. volkow: you are seeing me smile because this is a perfect example where science can transform the way that we can tackle problems, like in this case, addiction. it is possible because of our understanding of how the brain works and the circuits affected in addiction. and through brain technologies, to be able to manipulate them in a non-intensive way very selectively. that is what dr. rezai is doing, using low intensity focused ultrasound to basically restructure the way that the area of the brain gets disrupted by drugs. what he has shown is dramatic. the reduction, dramatic reduction, in craving and

anxiety in people with severe substance abuse disorder. this is an intervention that is not invasive, that requires one or two interventions, and has an effect that lasts a week if not four weeks. we are funding research to try to exploit how to maximize it so that others can take advantage of it. sen. capito: it is quite remarkable to watch. i've watched it myself. dr. hodes is also doing the same. well, it's brain, it is interesting how all of these are interconnected at some point. i know that you have had a long history of studying alzheimer's. what do you think about this as a potential breakthrough, in combination with what we are seeing with some of the pharmaceuticals and other available -- i don't know if they are full treatments, but at least improvements in how to handle alzheimer's? dr. hodes: thank you very much. as noted, it is gratifying to see convergence of technologies

and approaches. in this case, the progress in the past years in alzheimer's has been remarkable with the first fda approval of a drug for treatment of early-stage. what we have learned from the series of successful and unsuccessful trials is that the effect is very strongly related to the degree of decrease that can be accomplished. what we have shown in these studies in west virginia was that the use of targeted ultrasound in combination with an antibody to amyloid increased the effect in decreasing amyloid in the brain. preliminary data, which now will be followed up, with promise for making more effective in combination the treatments we have available. sen. capito: it can be done without nih and without the innovators we have. i would like to move over to the nci designations and clinical trials. and i don't know who wants to answer this. but, there are 14 states, including my state, that don't

have an nci designated cancer center. you know, you have seen the statistics. our cancer statistics in our state are very disappointing and devastating to us. it goes back to my rural area question. my understanding anecdotally through the professionals i've talked with is that in order to get this designation you have to have $10 million of repeating research into a center before you can become nci designated. in some rural states that don't have the resources and other things it becomes -- that becomes a big hill to climb. i am some jesting here that -- i am suggesting here that, have you thought about some kind of a carve out or a way for access for the more rural states to take into consideration the certain dynamics in a state like that as opposed to bigger

medical centers that are around the other 36 states that have it? i don't know who wants to -- dr. marrazzo: thank you for the question. first, the cancer centers are one part of the portfolio. and we would love to have more cancer centers. i know we are working with several that are emerging and working towards becoming comprehensiveness. in terms of reaching out to rural america particular with delivering on the discoveries to get to patients, which is what we want here, i will first say that the nci has long had a dedication to this, but i grew up in iowa and i understand very much what it means to have great distance from wherever you are to a major medical center.

it was at vanderbilt where, although we have nashville, the surrounding area had very similar issues. i will tell you a couple of things we are doing to try to take that on. beyond the cancer centers, we have 2200 sites that do clinical trials around the nation. our national clinical trials network is something unique in the world in terms of a broad network for clinical research. i think we have over 100 clinical trials in west virginia. and we also have the national community oncology research program which is another way of engaging community oncologists, because that is really were most patients get their care. but we know that is not enough. so we have engaged a group to work across agencies and with community centers to look at our capacity building opportunities. absolutely, it is a huge priority for us. sen. capito: thank you.

sen. durbin: thank you and welcome to the nih team. it was about 10 years ago when i met with francis collins at nih , went through one of the spectacular tours, which i recommend to my colleagues. i can remember as a member of the house when arlen specter, congressman john porter, decided to double the budget of nih. it seemed an impossible task, but they achieved it. it made such a difference in that agency. still we feel the benefits today. i ask dr. collins, what is it that i can do or we can do now? doubling it is not realistic. what is realistic? he said 5% real growth each year. i am going to pass out a chart here which shows what happened after that. i came in and engaged roy blunt, who deserves credit for his leadership on this, and my seatmate who will be here closely, senator murray, as well as lamar alexander, to make sure that year after year we continue

to give 5% real growth to the national institutes of health. this chart will show you that we did a pretty good job of it. the slope that heads on up there, the blue slope i would attribute to the team that came together. the orange part is the deficit where we failed to reach 5% real growth. i would just say two things. i commend my colleagues the theory that this is national security, this is national defense. ask the american people if it's worthy of their tax dollars. i am not going to take a penny away from the pentagon, but for god's sake, nih are doing things that save more lives than anyone working at the pentagon. [applause] so i encourage the creation of a new team. senator capito, you sound like from your questions are deep into this subject, and that's a good thing. i hope in the memory of roy blunt that you will join in the

effort as we move forward and i invite others to be part of it. and again, i count on senator murray as the chair of the full committee to move in that direction. let my colleagues, i have some specific questions about specific ailments in which we have taken an interest in. this success story for the national institutes of health has had its ups and downs in given areas. next week, 6000 blue flags will be placed on the national mall, each bearing the name of a grandparent, spouse, parent, child, neighbor, or friend battling als. one will bear the name of my friend and constituent who was active in the white house with president obama. his wife, a true courageous individual, used to work on my staff as a press secretary. and of course they have two little daughters.

they have been battling als for years, with some limited success. i use that word advisedly, because i know you hardly ever want to use that word around als. dr. collins called me at one point years ago and said, we have come to the conclusion that we are heading in the wrong direction in our research with als which is not coming up with anything after years and years of effort. what is the status of efforts today in research on als? >> thank. let me say that this is a tragic, tragic disease and we are approaching it with the sense of urgency it deserves. what has happened following, among other things, the act for als, which has been great for us, is the collaboration between nih researchers and the people affected by this terrible disease. they worked with us to set strategic priorities for tackling the disease. and these goals encompass diagnosis, treatment, management, prevention, and cure.

we have to use that word, because that is what our goal is. and we are in implementation now. let me give you specifics of implementation. there is an active partnership with the fda critical path initiative for drugs that are experimental, which is certainly critical for hope for these individuals. a new, accelerating medicines partnership for als that is done under the foundation for the nih will be announced imminently. also, some practical but critical things like data sharing, prognosis in the genetics of als, biomarker development, and more new trials. sen. durbin: i just have a few seconds left. the blood brain barrier seems to be a topic which i hear about more and more in breakthroughs in medical research. can you tell me in a few

sentences what we are finding? dr. bertagnolli: well, we are finding that there are techniques. this barrier prevents drugs from getting into the brain, where they need to work. we are finding certain techniques are able to open the barrier so that the drugs that we need to get in can pass through. the details don't matter, but i can tell you this incredibly active area of research to bring more therapies, effective therapies to those affected by neurologic diseases. sen. durbin: my last comment, geo blast toma as an example. we lost john mccain, ted kennedy, and beau biden and i hope that even at northwestern university where there are research breakthroughs that we can find a way to treat this malady more effectively. thank you. chair baldwin: senator hyde-smith. sen. hyde-smith: thank you, chairman and ranking member, and i appreciate our panel being here today. i am going to direct my question

to dr. rathmell. the university of mississippi, my state, is the only academic medical center, much like senator capito. we are working to achieve our nci designation, but we are not there yet. and ummc does a fantastic job, first lung transplant and heart transplant in the country in the early 1960's. i am proud of that. so we are working hard to get there but we aren't there yet. my question is, as we work to get there, we are talking about the trials and treatments and being able to participate in that. although we don't have that designation yet, bringing these trials and treatments to mississippi and what that looks like, and if we are eligible for

that, and how would that change lives in mississippi? dr. rathmell: yeah, absolutely. thank you for the question. so, as i said before, we do have multiple resources that we used to bring clinical trials in. the national community oncology research program is very active in your state. i will expand on the group that i mentioned before that we are convening. one of the cochairs of the group comes from baptist health care center in memphis. so, his group really sees a lot of patients in the mississippi area. that group is working across federal agencies, v.a., indian health service, cms, american cancer society, where there are grassroots efforts to see how we

can make clinical trials more accessible and more desired and more available. and then we are doing other things as well. smaller centers cannot necessarily have all of the staff that they need to run clinical trials, and so we have piloted a virtual clinical trials office which has been heralded as a different opportunity to take the clinical research nursing virtual space into these places. i think that that will democratize the ability to bring clinical trials a lot further. that is part of with this group will be looking at. sen. hyde-smith: thank you for that. and i am certainly going to ask for your commitment as well at ummc to help us get there. your recent editorial stressed the importance of clinical trials, the infrastructure to addressing and eliminating the inequities in the health care system, you highlighted that increasing community capacity to conduct cancer research is the key goal. and we sure hope that we are part of all of that. will this plan involve getting granting mechanisms?

and what impact would our declining budgets have on the initiative to help us all get there? dr. rathmell: i am so glad, we are clearly on the same page here. and we want to work with you to be able to do more of these things. the flat budget makes it tougher to make new granting initiatives. and we have to come up with new ways to be able to get these initiatives out there within the budget constraints that we have today. so that is where part of the reinvigorated cures act would bolster our infrastructure for clinical trials. we are looking at a future where we think that clinical trials could be much more available to patients everywhere, where they are. and that takes real infrastructure. sen. hyde-smith: thank you so much. and i have a little time left,

so, dr. bertagnolli, thank you for being here as well. the nih provides support to mississippi through the institutional develop award, the idea program. and we currently have 10 active idea awards totaling over $17 million. and as you know, the idea networks of biomedical research is excellent for funding biomedical research developments, including the network in mississippi colleges and universities. and they are collaborating to increase this research infrastructure in my state. and this is made possible through the nih commitment to that program and to expanding our national research capabilities. but i certainly encourage the nih commitment to the program and funding that it provides to mississippi and other states. how committed are you to ensuring that nih allocates at least 1% of nih funding to the idea program under your leadership?

dr. bertagnolli: so, senator, i can't give a specific percent, but i can tell you that this is truly among my highest priorities. to make sure that our research, which means our funding, is delivered and distributed through communities such as those served by the idea program, and even more so, not just the idea program alone. idea is capacity building, the ability to do research. what we are going to do now is bring the research grants in. the actual trials, the actual studies. i think that states like yours have done a great job to develop the capacity and now we will put that capacity to work. and that is going to be really exciting and i think of great benefit. thank you. chair baldwin: next, i recognize the chair of our full committee, chair murray.

sen. murray: thank you very much chair baldwin, and thank you for the work you do. nih is fighting some of our most devastating adversaries. cancer, alzheimer's, heart disease, opioid addiction, long covid -- [applause] -- to say nothing of rare diseases or pandemic threats. the lifesaving work at nih really shows this. i have been reminding my colleagues, if we are serious about protecting our families here, we need robust defense and nondefense spending. unfortunately, the tough caps that are squeezing dod are squeezing nih. they are threatening to slow or derail breakthrough patients and families desperately counting on today. i have been very clear that we have to invest in nondefense and defense. we need parity and we need to make sure that investments like medical research, which saves countless lives, get their due as well.

i am proud to say that we have a long history of bipartisan support for nih. i have worked across the aisle many times to advance this work for funding increase. i hope that we can come together to support this work again along with many of our other crucial domestic priorities. with that, dr. bertagnolli, i want to start with you. because i have a really important question i need to press you on. it is something i have been pressing on nih for years about how the agency will make sure that federal dollars are not supporting researchers who create a hostile work environment for colleagues and students. we have seen nih fall short when it comes to holding grantees accountable and complicit as institutions pass the harasser. we simply can't afford to have this agency's potential limited and its workers harmed by sexual harassment, discrimination, or bullying in the workplace. nih is in a position to set a standard for a safe work environment in the biomedical research field.

under your leadership now, talk to us about what steps you are taking to make clear to institutions and your grantees that these behaviors will not be accepted and will result in the loss of federal funding? dr. bertagnolli: thank you so much, chair murray. first of all, abusive behavior of any type, sexual abuse, harassing, bullying, any type is absolutely not to be tolerated. anywhere. we really thank you for your advocacy in championing this really important issue. so, specifics. first of all, thank you for your support in giving us the authorities to require that institutions that we fund must report to us anyone who has been found to exhibit this behavior. has a real finding of this behavior. and when that happens, their funding is withdrawn.

that is a solid and important step forward that you provided us with. however, we still have more work to do and we need your help. and so, i really look forward to working with you on that. i will say that it is still possible to pass the harasser if someone has been accused but has not really had a finding. it is possible for them to then move and get a new job and for us not to know what the results have been. let me tell you, we have been trying to combat this as well by having an anonymous tip line. and we do get and follow up on everything we get with anonymous tip lines. but we can work better to close this one remaining -- sen. murray: do you need a legislative solution? dr. bertagnolli: i think that we need to work with you. i think we don't -- i would like to work with you on that,

because i am not sure i exactly know the answer. we have been exploring it and i think that we could have a discussion and figure out the best way. so thank you. sen. murray: let's follow up on that. i also wanted to talk about the fact that women are half of the population, yet we are not near where we need to be when it comes to federal investment in women's health research. [applause] i strongly support the administration's efforts to tackle this problem head-on, including the executive order that president biden signed in march to better prioritize investments in women's health across the federal research portfolio. this is really a needed step to make sure women's health is better understood so women can get quality health care at every stage. there are significant gaps in what we know about diseases and conditions that impact women, and a lack of treatments available even for things as universal as menopause. talk to us about what nih is doing to advance women's health research, including for

conditions like menopause that are so common and yet so misunderstood and overlooked. dr. bertagnolli: yeah, thank you. so, nih has a long-term commitment to women's health in many ways. i will just call your attention to the framingham study. 75 years of understanding women's cardiovascular health. 50% women for those 75 years. we have gained a lot of knowledge over that. research across all of our institutes and centers address women's health. however, we absolutely can do more. the new initiative now gives us an opportunity to address current challenges that are really important to women. you have already illustrated a few, maternal health, a vulnerable time, mental health, postpartum depression, so many areas there that deserve more attention. alzheimer's disease, which has an increased risk in women. mental health overall.

the menopause transition. a normal time of life, but the change in hormones can be incredibly disruptive, and there are also long-term health effects like bone health that we still haven't developed the treatments and approaches that we need, although we have made some progress. we can do more. and then, finally, what is our approach? we are taking, instead of a bit by bit approach, we want to take a lifespan approach to women's health. a much more comprehensive and lifespan approach that coordinates across all our institutes and centers. sen. murray: i appreciate your attention to that and i think that i speak on behalf of many of us that we really want to see what we can do to make sure that nih is focusing on it. i mentioned menopause working with a number of women senators making sure that we have the research and knowledge and coordinate what we are doing here and have a better focus.

i think it was senator murkowski who said to us, if men went through menopause we would have an institute at nih. we aren't asking for that. we are just asking to make sure we really focus on it. so, thank you. chair baldwin: vice chair collins. sen. collins: thank you very much, madam chair. i am going to forgo an opening statement because i have so many questions that i want to ask. and they really fall in four areas -- alzheimer's disease, along covid, tick-borne illnesses, and also diabetes. dr. hodes, we have talked to so much over the years. and this committee has been generous in funding alzheimer's research in the last five years. and i would like to hear from you, have we made any progress as a result of that funding? dr. hodes: thank you for the

support from congress which has been enormously helpful and which has yielded important results. in the past year, fda approval of the first drug which targets the underlying process of alzheimer's. in terms of prevention, another important area, we have seen studies reporting the effect of repairing hearing deficits with hearing aids in those with high risks for alzheimer's, producing something like a 50% increase in cognitive decline in the population. early studies have pointed to the possible role of multivitamins in reducing cognitive decline, as well as targeted coaching to address the individual risk factors. biomarkers for the first time giving us an opportunity to test by imaging and blood biomarkers the various components, biochemically, molecularly, of what contributes to alzheimer's. so with all of these successes, some of which i have summarized these past years, where we are now is an understanding that

alzheimer's is a complex disease, meaning that multiple pathways that can occur in an individual. more importantly, we now have the ability to monitor this with biomarkers and studies that will identify the best treatment for individuals. a growing number of unique targets now in early stage clinical trials could see the next generation of drugs and lifestyle interventions too. i think we have had great advance in the work is only partially there. the increase in the understanding that we have of the disease targeting diverse approaches in the future years i think is enormously promising. sen. collins: thank you very much. i am encouraged as well. i think we are going to find out that alzheimer's is a multifactorial disease and that lifestyle factors play a role. inflammation, i think we are going to find is important, as well as the amyloid plaque that we focused on for so many years. dr. marrazzo, hhs recently

released the national public health strategy to prevent and control vectorborne diseases in people. this was required as part of the cade-hagen tick act, which i authored with senator murray and others building on the strategic plan for tick-borne illnesses. this is increasingly a problem in the state of maine. 20 years ago, we did not have ticks in maine that transported -- transmitted these kind of diseases like lyme disease. increasingly, it is all over the state of maine, they are all over the united states. it creates real problems. maine had a record high number of lyme disease cases in 2023. and as ticks continued to expand, those cases are likely

to increase. i was pleased to see the specific goal of reducing the number of lyme disease cases by 25% by the year 2035. could you briefly update us on the progress made in lyme and tick-borne disease diagnostics, treatments, and potential vaccines? because one problem is there's been a real dispute in the medical community on how to treat lyme disease. dr. marrazzo: senator collins, as someone who did my residency in connecticut and worked in old lyme for a summer, where i think i saw every manifestation of lyme disease, and recently coming from alabama, where we saw tons of tick-borne illness, i could not -- your comments could not resonate with me more. it's a really challenging infection, and you highlight the fact that we still, 25 years after, or however many, we don't even really have a good diagnostic test that we can use for it.

lisa rolla g is -- serology is very frustrating. it leads to a lot of misinterpretation. let me just say that we released our strategic plan, as you know, for tick-borne disease in 2019, and the support from this committee in this area has been critical in advances for both vaccine and the treatment areas. so in the basic area, one of the more exciting things is that we finished with both intramural and extramural scientists sequencing the genome, which is very exciting, because you can now go in and be more specific about genetic targets to try to develop some of these vaccines and figure out what are the antigenic components? what's stimulating this immune response that probably, frankly, informs post-treatment syndrome, what was previously called chronic lyme disease, but is clearly a post-treatment inflammatory syndrome. i'll jump ahead to that and just note that in 2021, i think, we

actually had a proposal out for work specifically on posttreatment conditions and awarded seven big grants to look at that, to try to figure out is that pathogen really persisting in the areas and how can we best address it. with the diagnosis, we're really looking carefully at a number of new serology approaches, some point of care diagnostics, which will help people a lot in the field, especially as people come to emergency rooms in the summer with these infections all the time. and the last thing is the vaccines. we have a pretty successful vaccine for dogs. there is a canine vaccine. we are figuring out why that vaccine is actually working, and we're trying to learn from that analogy to develop and refine the approaches to human vaccines, which has been really challenging. i'll stop there. there's more, but i'll stop there. sen. collins: madam chair, i'll ask that i submit my question on diabetes. i'm concerned about the cut that is in the budget and surprised to see that, and on long covid

as well, the recover initiative has been very controversial, the maine medical center, i'm proud to say, is involved in the research, but i'll submit that. madam chair: offensive line, and any opening i want to submit, at the end i will indicate the timeline we need for questions for the record. thank you. senator schatz: ? >> thank you. i think i speak for most of us when i say this is one of our favorite hearings, it gives us the most hope about the future. dr. bertagnolli, i wanted to start with this, we secured $4 million to launch nih's first ever hawaiian pacific islander health research office. our worry is this is going to take 17 months to stand up, so can you reassure me that this thing is going to get stood up quickly? i'm in no position to hector you for not already being up, but can you please reassure us that this is going to happen quickly?

dr. bertagnolli: this follows into a very active program to do much more to care for our indigenous peoples. sen. schatz: nih has funded hundreds of millions of dollars in pain management, research, what have we learned in the last several years about chronic pain treatment? dr. volkow: the whole infrastructure was energized to bring treatments that are effective for patients that are suffering from pain. pain is devastating. it's very, very prevalent. but it has been neglected. as a result of that, many people we think ended up getting drugs that were very dangerous, which,

of course, contributed tremendously to the overdose crisis. so thanks to the resources that have come from the initiative, we've been able to uncover new treatments for pain that are not effective, completely new targets. we want to manage people with chronic pain conditions and

other areas that we've never been able to investigate. sen. schotz: : what do you think by multipronged? dr. volkow: it's cognitive interventions to help the person live with pain. like many patient, for example. sen. schatz: how much of this is sort of, i'm not sure i'm using the right terminology, how much is getting into cms and the private healthcare sector, that's the question i have. it does seem like over the last three to five years, a lot of important discoveries that are not so, you know, they're not merely suggestive, like we think we know some things about pain management, but it doesn't seem to me that in its application in the healthcare context that they've woken up to this new treatment modality. dr. volkow: that's why it's so important in all of these projects we work closely with cms, so we can ask them the question, why is it necessary for us to show the science that would lead to its reimbursement? so we work very closely. for example, acupuncture is a perfect example of a partnership that's being developed, for it shows effectiveness, you want to be able to provide it to patients and be reimbursed. sen. schatz: you're not concerned these are two separate agencies that only talk when necessary?

dr. volkow: no, there is an active, very proactive interest in communication to commit ourselves to make collaborations across agencies. otherwise the science doesn't go into the patient. it stays in the journal, in the laboratory. sen. schatz: it's time for my annual question about psychedelic research. i think part behalf we have to do as a committee and congress, but draw distinctions around drug policy and a kind of move toward liberalization of drug policy, for maybe libertarian reasons, for criminal justice reasons, and the question of whether or not some of these things that are used recreationally and sometimes abused are medicine. that is a separate conversation. i am personally for drug liberalization. i am also a son of a principal investigator, and i'm not prepared to call this medicine until all of you do the adequate research.

so where are we with psychedelic research, and particularly, there's a bunch of accumulated data that seems to indicate that this needs supervision, and the application, the administration of the drug has to be combined with talk therapy and supervision. can you talk through how you see this? dr. volkow: you are absolutely correct. this is an area of tremendous excitement from the very pharmacology to actually understanding how to optimally use it on patients. because the data is starting to translate into evidence that it could be beneficial, what has happened is that clinicians are ahead of actually where the data

is. so it's being offered to a wide variety of patients without sufficient evidence, including the question that you ask. how do you optimally give it without producing risk and ensuring that you're having long-term effects? that's where we need to understand how the context which are giving the drug is going to influence your therapeutic response. it's crucial. but like anything else, what people get excited about, they want to start believing a little bit in fairy tales. it's not a magic. it's very promising. but we need more research. sen. schatz: thank you. sen. moran: thank you very much. dr. hodes, i was very interested in your answer to senator collins' question about the state of research regarding alzheimer's. let me ask an additional question. what's the latest in the research, what is the research show in regard to the connection between alzheimer's and down's syndrome? is that connection still viable and are we learning something about both at the same time? dr. hodes: yes, it's a very important connection between two very important conditions we need to address. as many may know, individuals with down's syndrome, likely related to the fact they have an

extra copy of chrome season 21, have, as they age, and the good news is living with down's syndrome, now age into older adulthood at a very high proposition, develop alzheimer's disease. there's been an extremely active program designed to study this, a network of longitudal studies, looking at markers to discuss how they establish a network for clinical trials. and clinical trials are already in progress. for example, looking at the effect of of a growth factor as therapy in those with down's syndrome or preventive therapy, as well as behavioral. we're working all the way from the basic science, connecting the trisome of down's syndrome and the relationship to alzheimer's, through clinical trials, infrastructure, and active clinical trials. sen. moran: what would change in the way that we would then

address the issue of down's syndrome? dr. hodes: certainly as down's syndrome relates to the risk of alzheimer's, this becomes similar to the rare but tragic early onset, dominant alzheimer's, and other aspects where we know with high priority, high probability, that individuals will develop alzheimer's. we know that years in advance, and importantly, now that we have biomarkers to track the presence of disease early, it allows us to intervene early in these populations to prevent. sen. moran: thank you. my following questions are really about process, mostly data. this can be to dr. hodes, or to you, dr. bertagnolli. with all the data that's now available in many instances, but related to alzheimer's, electric health records, diagnostic, clinical treatment results, insurance claims, medical images, is there a way now that nia can harness that data, uncover new insights and patterns that we can't see through individual research

projects? maybe that's my question. is that being done? dr. hodes: certainly the doctor can amplify upon it, because you're actually right. real-world data, the kinds you mentioned are critically important to fully understanding the way of what goes on with the health of the population, the way to maximize it. there have been very important real-world data studies already carried out around alzheimer's disease, and importantly, i would say that now the promise more than ever is for us to leverage these real-world data initiatives in the context of the large data initiatives nih-wide, federal agency-wide that i think dr. bertagnolli can comment on. dr. bertagnolli: i'll be quick. the data we used has got ton good enough that we can make life-altering decisions based on it.

right now, our real-world data is not at that level of accuracy, frankly. we are working really hard with fda and with partners across all of hhs to convert our current ability to gather real-world data into one where we really can harness it appropriately, use it with new analytics like artificial intelligence to make life-altering decisions. right now, it tends to be more hypothesis-generating than testing, and we're going to fix that. sen. moran: it's not sufficient data, it's determining how to harness the data to get it in a form that's valuable. dr. bertagnolli: it's the accuracy and the interoperability, you know, you got to compare apples to apples, not apples to oranges. some issues with how messy the data is in the clinical environment can really lead to mistakes. sen. moran: thank you for using a scientific term i understand. finally, this may be a statement because of the shortage of time. i raise this in last year or previous year's hearings with dr. taback. at one point in time, the funding of aarp was at the expense of more clinical research at nci.

i hope that's not a pattern. i assume that you will say that it depends on how much money you have, but i want to make certain that you are prioritizing nci competitive cancer grants with fy25 funding, dr. bertagnolli. dr. bertagnolli: absolutely we are, and our relationship with arpah is that we have our team members meet routinely to review what's happening in our senior agency and make sure that there's no redundancy and any way we can amplify, we do so. sen. moran: that was also directed to you, dr. rathmell. dr. rathmell: that's what i'd say as well. madam chair: senator kennedy? sen. kennedy: thank you, madam chair. dr. bertagnolli, i'm directing these comments to you, because you, of course, are the director of the nih, but i could also direct them to each member of this distinguished panel.

let me state a few things that i think most fair-minded people would agree are facts. the national institutes of health are more to the point the men and women there. are one of the most extraordinary collections of minds in the world. maybe in all of human history. your work, their work, has saved billions of lives. their work, your work, has improved the quality of life for billions of people, not just in america, but worldwide.

the national institutes of health is part of, at least in america, but i think the world as well, is part of the institution of public health. another fact in my judgment. as a result of the pandemic, the institution of public health, at least in america, and i think in some respects throughout the world, has been tarnished. and that's dangerous.

that's very dangerous for america, for the world, when, if we have another public health crisis. i don't care to partake in whose at fault for that -- in who's at fault for that, or depending upon your perspective, who receives the credit for that. i'd like to suggest that we do something about it and that we learn from it.

and i think the nih is the perfect group of men and women with the requisite credibility to do that. now, here are my suggestions. number one, the nih needs to clear the air on gain of function research. i would gently suggest that you -- i don't know you could do it in a symposium, you could do it in an extended press conference with some of the your best minds making presentationses. be technical, but also speak directly to the american people in a way they can understand. tell them what gain of function research is. tell them how it is funded. tell them what research projects, the american taxpayers are funding. tell them what, if any,

america's involvement was with the gain of function research at the wuhan lab. tell them the benefits of gain of function research. explain to them the risks, and be transparent. that needs to be done. and i think the nih could lead. number two, at a different symposium or extended press conference, i would like to see the nih take the lead in speaking to the world and to the american people about what we learned from the pandemic. what did we get right? what did we get wrong? here's why we got it wrong. here's why we got it right.

here's how we saved lives. here's how we could have saved more lives if we had known what we know now. the american people, they don't read aristotle every day, they're too busy earning a living, but they get it. you know, hindsight is wonderful. i think if you would consider doing those two things, we could remove some of the tarnish on the institution of public health in america. and i'll conclude with this point. i know there are risks here. and i know some of you are thinking, you know, what planet did kennedy just parachute in from? why do i want to get mixed up in this political hot mess? because it's important. and it's not going away, folks. neither one of those topics is going away.

so i would gently, again, gently suggest you put those extraordinary minds to work and consider doing those two things. dr. bertagnolli: on behalf on all of us, thank you, senator. madam chair: senator brit? sen. britt: i want to thank you for appearing before this subcommittee. i want to begin by expressing my deep gratitude to you,

dr. bertagnolli. is that right, bertagnolli? no, try again? how do you say it properly? not that i'm going to be able to do it. oh, yeah, the alabama in me, you know? i love it. ok, ok, good. madam director, how we do that? thank you so much for visiting alabama this year. i am deeply grateful for your time and letting you come and visit with the incredible men and women that work there, see the work that's being done, figuring out how we can partner to continue to change lives for the better. really, really appreciate it. and then also, and here we're going to have another challenge with how to say your name, is it -- marrazzo, jeez louise. we are very proud, obviously, you having been at uab, and to see you in this job now, you know what a special place is uab is, the tremendous work that is done there, and look forward to

working with you in your new position. as you both know, in alabama over a third of our 67 counties are classified as maternity care deserts, areas without access to birthing facilities or maternity care providers. last fall, three more alabama hospitals announced closures of their labor and delivery departments, leaving both shelby county and monroe county without access to labor and delivery services. additionally, alabama hams the highest maternal mortality rate in the nation. i'm of the mindset, as i believe probably the men and women sitting at that table as well,

this is a crisis we should be able to fix. if you look back to 2019, nih launched the implementing a maternal health and pregnancy outcomes division for everyone, the improve initiative. madam director, could you speak to the importance of this program and why the nih felt so strongly that standing up the improve initiative was necessary, even without a sustained funding source? dr. bertagnolli: absolutely. thank you, senator. pregnancy-related complications related in the deaths of about 1,200 women in 2021. we're still waiting to see the figures coming in for the last couple of years. but this, it was just an enormous jump. and with much higher rates in black women, which is also terrible. we're really -- this is one of -- improve is one of many efforts, a really important one, but one of many we are looking to to tackle this problem. it's mental health. the institute and mental health plays a role. it is also to a certain degree associated with substance buss disorder as well, which we know. all of these things. all of these things intersect. sen. britt: that's why it's so important. i want to say thank you. improving healthcare for women before, during, after pregnancy is truly vital.

and i really am thankful for your leadership in this space. i want you to know that i want to continue to partner. as you mentioned, though, obviously this research funding is so important, but yet this research is so important, but really lacks a sustainable funding source. last month i was proud to partner with a senator from california on the nih improve act, which would authorize in statue and provide consistent funding for this initiative. i just to want thank all of you in the nih staff for providing your offices to help us with technical assistance on this, to make sure that we could get this important bill out there. i am committed to continuing to work with senator butler to find a way to get this passed into law. as you mentioned, not only is alabama the highest that disproportionately afacts the black community, and we need answers and need them now. we're going to keep working on that to help with america's maternal mortality crisis. and i want to say, i know i'm almost out of time. two quick questions. when it comes to c.r.'s, which is what we end up seeing happen here, unfortunately, and i want to commend chairwoman murray, i want to commend vice chair collins, this committee did its work last year. we finished in july 27, all 12 bills out of committee. unfortunately, we did not get those to the president's desk until 236 days later, 174 days into the fiscal year. can you speak very quickly about what a c.r. does to your agency? oh, look at this. i get a reaction from the whole crowd. can you just speak very quickly to that? dr. bertagnolli: i'm sure, we don't know exactly -- anyone knows this. if you don't know how much you have to spend, it's very hard to plan and make all of the strategic decisions we need to make that don't come at the very end of the year. we do the best we can, and are certainly grateful for our funding, but it is challenging. senator britt: would you allow me to ask one more question? thank you so much.

last question, in your visit to alabama, you were able to see some of the research that we are doing there, and how our community, our diverse population in alabama is really a great place for clinical trials. could you just speak to that very quickly as to why you feel like those things match up so well? dr. bertagnolli: it is absolutely critical that we serve our populations that are having some of these extraordinary needs that all intersect, that have to do with community in a very effective way with our clinical trials, infrastructure, and so that is why we're launching a new clinical trials network devoted to primary care, to do exactly that, to get into the communities, doctors, clinicians, on the front line, like the ones that we were able to visit in alabama and in west virginia and in other parts of the nation. we're excited about this.

it will be an all of nih effort to work with communities to get the research they need. sen. capito: we each have a couple of really make questions, so we're going to start a second round. sen. baldwin: hopefully quickly. dr. bertagnolli, new data from the national science foundation reveals the largest drop of scholars in over 40 years. employment indicators suggest that life science ph.d.'s are choosing to pursue careers in the industry instead. in order for america to out-innovate the rest of the world, we must invest in the next generation of researchers. i was proud to author the next generation researchers act with my colleague, senator collins, to improve opportunities for new and early stage researchers. since this bill was signed into law as part of the 21st century cures act, nih has increased funding for early stage investigators by 63%. i was pleased to see the nih recent plan to increase the minimum post-doctoral salary by

8%, raising it to $61,008 per year and provide an additional child care benefit. this is a major step in the right direction. but it falls short of the $70,000 minimum salary that your advisory committee recommended. so dr. bertagnolli, how is nih tracking the impact of the sty spend increase, and why aren't cost of living adjustments part of that equation? dr. bertagnolli: thank you for that. i would say how do we better support our young, the next generation, the ones who are going to transform the world, that discussion happens every single week in our meetings across all of our nih directors. we need to support them on so

many levels. you hit briefly on an increase in stipend for post docs that came out of a working group of the advisory committee to the director. many other parts of that working group, we are responding to. i think you also alluded to why haven't we gone farther faster, and farther faster, we are left with a challenge of do we fund more researchers at a lower level, or do we fund smaller numbers at the full level that the committee asked us to do? you know, it was an economic calculation we did. we have made a declaration that as funding allows, we will increase it to the full $70,000 a year. that was requested or advised by the committee over the next hopefully three years. and then finally, you also talked about the early stage investigators support. we do have special review

criteria for early stage investigators. we hope they get a little less stringent funding rate, so we really actively encouraged, and we put out a challenge every year across all of our institutes and centers to achieve at least, used to be 1100, yet last year we made 1600. i'm optimistic we'll get that this year senator. senator baldwin: an estimated 20 million americans continue to suffer with the long-term effects of covid-19. more than three years have passed since congress appropriated $1.2 billion to the nih for long covid research. nih has moved slowly to enroll patients in clinical trials, and there's still zero fda-approved treatments for long covid. critics of the recover initiative fear that it may not deliver any meaningful treatments.

getting this right has massive ramifications, because it will dictate how doctors across the country treat their patients and impact people's ability to access work accommodations, disability benefits, and more. so dr. gibbons, why has the pace of research been so slow, and what can you tell us about the status of clinical trials for long covid? dr. gibbons: thank you for question, senator. as you know, long covid is a debilitating disorder, inflicting great suffering. it affects nearly every organ system in the body and involves, quite frankly, the missionaries of many of our institutes in that regard. let me turn first to our nih director, dr. bertagnolli, for addressing your question. dr. bertagnolli: dr. gibbons,

thank you, and chair baldwin, i am very pleased to speak for this as the nih director. really to emphasize that this move is really considered a full nih activity, long covid, and the similar condition are terrible diseases. we must find better ways to treat and actually care, restore of lives of these people who are affected by this terrible and, you know, the increase related from this new disease of covid, it's very tragic. what's already been accomplished, i'll be very brief there. what has been accomplished is to understand the new disease that dropped on us that we didn't understand.

15,000 people with biospecimens, their electronic health record data, have allowed us to do the following. five platform clinical trial structures focused on what people need us to fix, dysfunction, cognitive, the brain fog, the cognitive challenges, fatigue, sleep disturbances and viral persistence. so targeting those five key really destructive areas. we now are, and fully admit we are not where we want to be in terms of a rapid, nimble clinical trial, an enterprise that's testing promising treatments very quickly. that is our focus right now, moving forward to do that. and finally, you know, we have launched eight trials. new ones are pending, but as i said, we have clinically characterized platforms and are ready to go into action and accelerate approaching this. and the last thing i want to say about long covid, we are so grateful for our partnership with the people that are affected by this. they have taught us over the last two years what we needed to do. now we just need to deliver for them. chair baldwin: i'm going to recognize vice chair capito foreone remaining question, and then i will recognize senator that even. go ahead, senator capito.

senator capito: you're either having your best day or worst day, because you haven't gotten a question yet. i wanted to ask a question about a nih study through your institute that found higher mortality rates for patients on respiratory story in rural, intermediate nature care units. i have a large rural population. what advice would you give, or what do you think could come out of this study in terms of helping rural, intermediate i can't tell care facilities being able to change the results of the study? dr. gibbons: thank you, senator. you bring out an important aspect of your earlier comment,

in which we recognize that rural america and our systems need to focus in on where the burden and suffering is the greatest, and clearly when it comes to intensive care units, there's actually a lower proportion per capita in rural communities. and we know that it is a challenge. we're hoping, we're testing strategies, many of which involve telehealth, in which we can ensure that the care is at the level where we can improve those rates of recovery in the context of rural communities. for example, one of the other

elements of that challenge involves chronic disease in which we know that pulmonary rehabilitation can actually reduce hospitalization rates for those with chronic obstructive pulmonary disease, and we've tested that in rural settings and shown that it's in the context of where patients are in rural communities. similarly, we have established cohort studies focused in on rural communities to understand the whole trajectory of chronic lung disease and heart disease, our rural initiative in kentucky, alabama, louisiana, mississippi, so that we really want to be where individuals are, understand their risks, and improve their care, including the use of mobile c.t. scan to further understand those things. senator capito: i was talking with one of my west virginia university doctors about a mobile unit for more, to look more at heart. i just want to thank all of you. this has been, it is always so informative and hopeful. and also, my last comment would be to you, dr. bertagnolli, 27 institutes, that's a lot to manage, not just physically manage, but there's so much interplay between whites going on -- between what's going on. as we look at a time of dollars shrinking, we got to be more efficient. so any efficiencies, and i'm not asking to you speak on this, any efficiencies that can be found across the 27 institutes, i think you're going to reap the results of that, and i know that's something that you and i talked about earlier. so thank you all very much.

appreciate it. thank you.

senator shaheen, i haven't vote yet. senator shaeen: thank you for holding the hearing, and thank you all so much for not just for being here today, but the work you do every day. i want to focus my questions on the area of substance misuse, and dr. volkow, you have been so helpful and willing to come to new hampshire to see our challenges there. while c.d.c. shows overdose deaths decreased last year for the first time since 2018, we still lost 107,000 americans, 430 in new hampshire. overdose deaths continue to take a devastating toll on not just those affected, but their families, friends. last year we discussed the important work of the heal initiative. can you give us an update on the development of medications for vaccinating individuals against substance use disorders? dr. volkow: i actually am keeping an eye on this problem, and yes, there was a 3% decrease in 2023. if you look at certain areas, they continue to increase the mortality, and numbers are unacceptable. so there are many strategies. one of them is how we can

provide better treatment for people that otherwise will die because of an overdose. and vaccines, antibodies has been one of the targeted. we have started actually, we completed a trial in phase two for moan clonal antibody against methamphetamine. the number of people dying from methamphetamine has continued to increase. we have no treatment whatsoever. unfortunately, the outcome did not reach the one that was set up by the f.d.a. the company is withdrawing, unfortunately. we are in the stages of also starting trials with monoclonal antibody. in the last clinical stages for a fentanyl vaccine.

so we are advancing and the funding has enabled us to accelerate that research. there are many challenges, but we have multiple potential treatments for which the results come forward, we will have better interventions for reversing overdoses, better interventions, not just for treating opioid use disorder, but we have no medications for this disorder, which as i say, the mortality has continued to increase. so we need to continue to do this in order to be able to bring the treatments to people. senator shaheen: i appreciate that, and we are seeing that in new hampshire, the number of cases of people overdosing on meth has gone up, and as you point out, there's no treatment. one of the challenges that we're seeing in new hampshire is that so much of our funding and programs have been tied to specific drugs, and we need more flexibility in what those programs can do to address other drugs other than just opioids. would you agree with that, that it would be helpful to see more

flexibility in funding? dr. volkow: 100%. in fact, what the science is telling us is that the problem we have in overdose is very rare to see someone dying with just one system. it's also very rare to have a person that has a substance use disorder that only consumes one drug. so the strategy now, and genetically, genes that make you vulnerable for addiction in general, so the strategy is how do we do interventions that are going to be beneficial for any type of addiction regardless. and certainly in terms of how we deploy care and how we fund it, there should not be distinguishes, distinguish this or the other, because it's not a way that the cases are presenting themselves. sen. that heat: thank you, madam chair, i hope as we're looking at the funding in the budget we can look at that issue and try to ensure that we're not directing funding just at one substance. my other question has to do with diabetes.

and dr. bertagnolli, i think i'm going to direct this to you, as i understand. last year, i asked the doctor about beta cell and stem cell therapies, cutting-edge technologies. we're seeing companies, a new company in new hampshire that's working on that and has tremendous potential for curing. i say that directly, curing diabetes. i have a granddaughter with type one, so we know very directly the challenges. can you talk about where nih is and plans to address investments in diabetes-focused cell therapies? dr. bertagnolli: absolutely. this is a very exciting area. there's great hope. there's i think three wins we have here that's come out of the special diabetes program. the first is the first drug that can delay the onset of type one diabetes severe symptoms by almost three years, so that's a win.

the second, you've already referred to it, the cell transplants, where we're finally starting to know how to protect these precious islets from destruction by the immune system. we're hoping this is one of those things, where you get proof of concept, then you can really expand and do better. and then finally, there's also good technology in new artificial pancreas technology, and so much better testing, insulin control. i just want to raise one issue, though, since i think we both really care about this disease. we still got a long way to go with underserved people, minorities, very young people. we're getting some advances. we got to make sure everybody gets them. sen. shaheen: i couldn't agree more with that. senator collins and i co-chair the diabetes caucus. we have legislation we're working with some of our other colleagues to not only cap the out of pocket costs of insulin until we get these cures, but also to cover uninsured who definitely are experiencing more of the negative effects of the disease.

so thank you very much for what you're doing. thank you, madam chair. chair baldwin: thank you to the entire panel we have today of institute directors. we really appreciate your presence and your work. the record is going to stay open for one week for additional questions. now the subcommittee will stand in recess.

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