Transcripts For CSPAN NIH 20240706

The Senate Budget Committee Looked at her House Republican approved proposal that raised the National Debt limit to spending cuts. The chief economist and others testified, watch that tonight at 8 00 eastern on cspan. Also on our free mobile video app or online at cspan. Org. Next the acting director of the nih testifying on the president s 2024 budget request for the agency and discussing youth Mental Health, the Opioid Crisis, and diversity and in Biomedical Research. This means providing our scientists with what they need to conduct cutting edge to discover and develop treatments to help patients fighting disease. As i happen to be the granddaughter of an nih funded scientist, my grandparents raised me and i understand what an Important Role Biomedical Research plays, not just in treating and curing disease, but also in bolstering our Economic Growth and ensuring that america is a Global Leader in innovation. We cannot afford to have nihs potential limited or even worse, have its legs cut out from under it yet. That is precisely what the House Republicans have proposed to do with their fiscal year 2024 budget caps in the bill that they passed last week. Cutting spending as they have proposed would mean slashing approximately 22 from programs next year that support a range of programs including supporting our veterans, keeping our communities safe and healthy and doing Vital Research to find cures for illnesses and diseases. It would mean a cut of over 10 billion in fiscal year, 2024 alone for life saving medical research at nih an extreme cut like that would mean nih could fund 5000 fewer grants and would shutter hundreds of labs across the country. It would stall training for the next generation of researchers and result in fewer drugs being developed for cancer. Alzheimers disease, diabetes, serious Mental Illness and other devastating conditions. This would slow progress to find treatments for disease and weaken americas competitiveness particularly against china and increase our reliance on Foreign Countries for Clinical Trials and drug development. Fortunately, here in the Senate Ranking member, capito and i are focused on writing a bipartisan labor hhs spending bill to move our country forward. We are committed to working together to find compromise. Our communities are depending on us to continue providing the support needed to combat the opioid epidemic, the Mental Health crisis and so many other challenges every day across wisconsin. Researchers at world class institutions like marquette university, the Medical College of wisconsin and the university of wisconsin system are working around the clock and making groundbreaking discoveries. Im pleased to say this subcommittee has a proven track record of recognizing the tremendous importance of supporting our nations Biomedical Research community, acting director tayback. Im pleased to see that the administrations budget request for nih would increase funding for the cancer moonshot and Mental Health research. And i look forward to learning about the agencys plans to develop, to deliver new cancer treatments with fewer side effects and develop a precision psychiatric initiative. But im disappointed to see programs that aim to address maternal mortality. The opioid epidemic, alzheimers disease and Health Disparities and develop a universal flu vaccine to name just a few that those programs remain flat or are actually cut in the proposal. I look forward to working with my colleagues to ensure nih has the resources it needs across its 27 institutes and centers to continue the progress of recent years. I have been glad to see nih working to examine barriers to diversity among its researchers and within its Clinical Trials and increase Career Opportunities for groups that are underrepresented in Biomedical Research. But there is still a long way to go. And in the meantime, these remain real problems with real consequences for research. Finally, before i turn it over to senator capito, i want to mention an article published last week in science revealing nihs failure to discipline an investigator with a known documented history of Sexual Harassment in march of 2022. After years of urging nih to take decisive action. This subcommittee wrote policy into law requiring institutions to inform nih of disciplinary actions taken against harassers to ensure accountability. Yet, following a far reaching investigation at Florida State university that resulted in a 131 page report detailing years of severe pervasive Sexual Harassment. Nih approved the transfer of an investigator from f s u to san diego Biomedical Research institute and awarded him a new 2. 5 million grant. Unsurprisingly, the abuse continued driving at least one trainee out of the institution. It is outrageous that nih is complicit in this case of past the harasser. And i want to know what youre doing to hold the researcher and institutions accountable and how you will prevent incidents like this from happening again in the future. So, acting director tayback, i look forward to your testimony and appreciate your being here today in a moment. I will turn it over to Ranking Member capito for her opening remarks following senator capito Opening Statement. We will hear from acting director tayback and after that, senators will each have five minutes for the first round of questions. Thank you madam chair. And its i agree with you. We, we need to do this together, work together. We have the vice chair here. Shes riding hard on all of us as, as she is with the chair. So we are hopeful that we have a successful result. Doctor, thank you for being here and for your role in performing the functions as nih director. Really appreciate this. Youve done this since december 2021 have helped your nih through, through some interesting times. Maybe youll write a book or something. Doctor volkoff. Thank you, doctor ho. Thank you, doctor gordon and doctor loy. Thank you for being here today to discuss some of the Biggest Health issues facing our nation. This is an important opportunity for us to hear about the nih Budget Proposal and better understand the priorities for fiscal year 2024. Ive mentioned before that our jobs will be more challenging this year given the debt ceiling and fiscal challenges that face our nation support and funding for Biomedical Research at nih has long been a bicameral bipartisan priority. The budget proposes 48. 8 billion in Discretionary Spending for n ih including 21st century cures and arpah. Nih funding has seen almost a 60 increase for the last eight years and these investments are good reasons are for good reasons. Since nih research affects every american in every way. As i look through the dice, i think of all the people that i know in my home state who are affected by your different disciplines. In West Virginia nih supports 952 jobs and 142 million in Economic Activity during 2022 alone, through the 49 million that were received in grants and contracts. This year, we need to prioritize areas of agreement such as funding to find cures and treatment for cancer, including Childhood Cancer and funding for our Academic Research institutions. For example, in the fiscal year 2023 omnibus, we reauthorized the Childhood Cancer star act which i led with senator jack reed and included in their 30 million to continue to implement it. The cancer star act directs the National Cancer institute to advance Childhood Cancer research, better understand and track the disease and enhance support for survivors and those affected by Childhood Cancer. Childhood cancers are different than adults and the Specialized Research is very important, West Virginia ranks above the national average, both in new cancer diagnosis and deaths. So im pleased that the budget devotes increases to the cancer moonshot and significant resources to the advanced Research Project agency for health or apa h to focus on finding cures and treatments for cancer. Another area i greatly support is for the nih Institutional Development award or the i dea program. There have been few programs as impactful to my state as the idea program and im disappointed that these awards are flat funded in the president s budget. West Virginia University is one of 17 Research Institutions nationwide to participate in an idea and eco program that was started in 2016. The collaboration between wvu establishes pediatric Clinical Trials throughout the entire state of West Virginia so that doctors and patients have access to the same treatments that are available at wus hospital in morgantown. Wvu is also a leader in nih covid research. Dr. Sally hotter with wvu is co leading an ied States Consortium initiative to better understand the long term effects of covid. The Research Capabilities at West Virginia university continue to prove that our Higher Education institutions can compete are are higher. Our West Virginia institutions can compete with any other institution in the in the country. Im disappointed in some of the overall funding levels in the nih proposed budget. First, there are no new resources specifically for Alzheimers Research in nih which doctor ho knows is a great passion of mine and in an estimated 6. 7 million people, 65 or older are currently living with alzheimers in our country. And the National Cost of caring for those alzheimers and other dementias is estimated to reach 345 billion. Not to mention the emotional costs on our families and caregivers. Theres a lot of Exciting Research going on in this area. Alzheimers and Dementia Related Research must remain a a a National Priority also Substance Abuse challenges or Substance Use challenges facing the nation basically are receiving Just Lip Service in this budget as the National Institute on drug abuse is receiving flat funding in 2021 fatal overdoses claimed nearly 107,000 americans. Doctor volkoff has visited my state and has seen first hand how we are in the crosshairs of the opioid addiction crisis. I know we are anxious to have you back in West Virginia. And frankly, id welcome all of you to visit West Virginia, not just to see and learn, but also to enjoy the state as well and meet the dedicated professionals. I know we are dealing with a tight budget year this year but investments in Biomedical Research are so important for the future of our country. Listen, i want to thank all of you for what you do. I should have started with that because youre in an exciting time for research, an exciting time for breakthroughs and we want to support you as well as we can. Thank you, senator capito. And i will now introduce our witnesses. Doctor lawrence tayback is the acting director of the National Institutes of health. Doctor Joshua Gordon is the director of the National Institute of Mental Health. Doctor richard hoti is the director of national, the National Institute on aging. Doctor douglas lowy is the Principal Deputy director of the National Cancer institute. And doctor nora volkov is the director of the National Institute on drug abuse. I want to thank you all for joining us and and underscore what senator capito just said, thank you for what you do and how you have devoted your careers. Acting director tayback, you may deliver your opening remarks. Thank you, chair baldwin, Ranking Member, capit and distinguished subCommittee Members. Im honored to be here today representing the National Institutes of health. Our mission at nih is to seek fundamental knowledge about the nature and behavior of Living Systems and to apply that knowledge to save lives and improve health. Fundamental translational and Clinical Research are critical components of the Biomedical Research enterprise. However, fundamental or basic research rarely makes headlines. Understanding how proteins fold or how gene activity is controlled, doesnt often improve human health immediately. But fundamental research is essential to making breakthrough discoveries that lead to treatments and cures. A paper published last friday in the journal of the American Medical Association indicated that nih funding contributed to the development of 354 out of 356 new drugs approved by the us u. S. Fda from 2010 to 2019. Nih supported the foundational evidence that pharmaceutical companies leveraged to develop life saving drugs and many thousands of patents. Ive spoken to the subcommittee previously about how fundamental research from nih supported scientists and collaborators positioned the United States to develop covid19 vaccines on an unprecedented timeline. But there are many other examples of how fundamental research has led to improvements in the health of americans. One such case is the breakthrough stroke treatment, tissue plasminogen activator or tpa that resulted from decades of work conducted across biological disciplines. Researchers first found the enzyme on cells that line blood vessels in 1946 3 decades later, certain cancer cells were found to secrete tpa in large quantities and once purified the purified enzyme dissolved clots in animal models. A decade after that, using Recombinant Dna Technology and nih supported Clinical Trials led to the approval of t p a to treat heart attacks. And then in the 19 nineties, tpa transformed the treatment of stroke allowing most patients who are treated within three hours to make a full recovery with far reduced health costs. Many of our most important advances have come when we were not even thinking about a direct application. Decades ago nih funded research on how bacteria protect themselves from viruses. No one involved could have predicted that this research would lead to tools that have revolutionized all of medicine because of research on recombinant dna. In the 1960s , it became possible to produce drugs like human insulin and tpa for widespread use. Starting in the 19 eighties. 1980s. Continued investments led to the transformative approaches for gene editing such as crispr. This highly Versatile Technology has revolutionized how basic research is conducted and how diseases may be treated, including such things as sickle cell and antibiotic resistant urinary tract infections. Discoveries build upon each other in ways that we cannot necessarily predict sustained addict. Sustained Public Investment addict. Sustained Public Investment and fundamental research is essential to the discovery and development of new medical treatments to foster the application of fundamental research. Nih continues to support Translational Research studies and collaborate with industry to advance crucial interventions for the public. As most of you know, naloxone is a life saving treatment that can quickly restore normal breathing when somebody overdoses on opioids. This drug is an essential tool in the fight against the Opioid Overdose Crisis which claims 188 lives in the us every day injectable naloxone was used for years, but an easier intervention was needed. In 2013, scientists from the National Institute on drug abuse created a stable formulation of concentrated naloxone for use in a nasal spray injector developed by an industry partner. Working together they conducted Clinical Trials to evaluate the nasal spray formulation, providing the pivotal data to support fda approval of narcan in 2015. And just a few weeks ago, the fda approved narcan for use without a prescription. Nih supported discoveries have affected nearly all of our lives from Research Studies that lay the foundation for future advances to Clinical Trials that evaluate potentially lifesaving interventions. Your continued support of our mission to help people live longer and healthier lives is crucial. I thank you for your time and i welcome your questions. Thank you, doctor tayback. We will now begin our round. First round of questions. I have several questions that i want to get to. But first, as i noted in my Opening Statement, the House Republicans last week passed a bill that would have devastating impacts on Biomedical Research. What they have proposed would require deep cuts to the nih and would lock in those cuts over the next decade. I outlined a list of impacts i believed it might have on nih very briefly. Is there anything that you would like to add about what a more than 10 billion cut would mean for nih research including if those cuts were sustained over the next in addition to the next decade . In addition to the numbers that you provided chair baldwin, that there will be a Chilling Effect on the entire Biomedical Research enterprise. It will decrease interest in research careers. And as, as you well know, in times of fiscal stress , disproportionately, young investigators are the ones who suffer the most. It really bodes poorly for the future of biomedical science. Dr tayback, research that involves enhanced potential pandemic pathogens must be accompanied by safeguards and conducted under strict biosafety and biosecurity measures. There have been two biosafety incidents involving the h5n1 virus at the university of wisconsin madison campus, the cdc considered a 2013 incidenc e is very serious exposure which required a researcher to quarantine for a week which they ended up doing at home rather than at a dedicated quarantine facility. Nih officials didnt find out about an incident in 2019 until 10 days after a trainee had been exposed. In march, the National Science Advisory Board for biosecurity published a report recommending the u. S. Expand the scope and impose stricter oversight of federallyfunded research on dangerous pathogens. This includes nihfunded studies overseas. Dr tabak, how will the nih increase its oversight of this research and ensure institutions are held accountable when incidents happen . So, as you know, the nsabb recently provided its report to hhs and this is informing ongoing discussions across the usg. I cant presume what those discussions will yield but i can speak to what nih is doing in in the meantime. First, we are considering how best to elevate the transparency and oversight of the decision process that we use in nih that feeds into the hhs oversight function. We are also developing approaches to partner more effectively with our applicant organizations by developing new materials which will clarify both institutional and nih responsibilities in the process. We are also performing a comprehensive review to our existing recombinant dna and synthetic molecules policies, to ensure that we capture biosafety considerations related to emerging technologies like crispr. I appreciate your insights. When we look at this oversight, we want to make sure that we dont prompt scientists to move their experiments to countries where there are less stringent requirements. Dr. Volkov, im concerned that this budget request leaves Opioid Research flat footed. Our communities continue to struggle with an Opioid Crisis and fentanyl is making it so much worse. Fentanyl is 50 times stronger than heroin and 100 times stronger than morphine. And it has become the leading cause of death for people 18 to 45. In my home state of wisconsin, synthetic opiates, primarily fentanyl, were identified in 91 of opioid Overdose Deaths from 2021 to 2022. I have heard from families across wisconsin who have lost loved ones to internal overdoses impersonates. We have to utilize every tool in our toolbox to stop it from coming into our country, to prevent its use, to bring an end to this national crisis. Last october, the Wisconsin Department of Health Services distributed 120,600 Fentanyl Test strips to organizations across the state to help prevent drug Overdose Deaths. Doctor, what does Research Show about how effective Fentanyl Test trips are in a realworld setting . Guest the data is actually showing that they are effective in changing the practices of people who are entering to use drugs. Research isnt going to actually strengthen the guidelines that can then inform the users on how to take these drugs in a safer way. Thank you. I see that my time has ended. I will turn to senator capito. Thank you. I wanted to talk about the Childhood Cancer that i spoke about in my Opening Statement. We talked about the star act. I guess what i would ask is, where are you seeing the most promising advances in terms of able to make advances in the pediatric cancer space . And what what some of the differences are the top challenges that you have . Senator capito, i really want to thank you and senator reid for the initial passage of the star act and its reauthorization this year. As you know, we are able, as a result, to support areas for cancer survivors, for improving our buyer specimens, and then for collaborating with the Childhood Cancer initiative to develop molecular characterization in more detail. We hope that these and other advances will be able to improve the lives of children who develop cancer, both with improved treatment, as well as with less toxicity. There have been several fda approvals over the last few years, but it is not enough. Children who get cancer, as you know, terrible. Children who die from cancer, even worse. We are working hard to support research that specifically is targeted to molecules that are able to interfere with specific abnormalities in a wide range of Childhood Cancers. As you said in your Opening Statement, Childhood Cancers are not adult cancers in children, but they are qualitatively different, and we take advantage of that. Thank you. Thank you. I want to ask about the funding of alzheimers, which makes absolute no sense to me when we see the raging numbers. We know there have been a lot of breakthroughs recently. But i also want to ask you about parkinsons disease, because i dont know whether it is related to alzheimers, but it is a neurodegenerative disease. Senator murphy and i just put a bill in, a National Plan to end a parkinsons act which would coordinate the Research Across the federal government in other ways. So can you, can you first talk about alzheimers and then the parkinsons issue . On the alzheimers, the budgeting issue. And on the parkinsons, what breakthroughs, what are you seeing in your research . Alzheimers disease research, we are clearly at a very exciting juncture as you may have seen in the news. To be perfectly clear, the outcome of congressional support and nih funded research has led to Clinical Trials which are now shooing effects for the first necessary funds to continue research in this area are important as we recognize it in the brain. No one treatment is likely to be sufficient for all. There are now some 59 early stage, phase i and phase ii Clinical Trials, only eight of which are targeted to amyloid. The other 51 towards other diverse targets such as inflammation, protein folding and ultimately is going to the ability to personalize which of these is most effective for individuals. So your question about budget and momentum reflects on the fact that if there were a limit in resources, we would of course, do our best to ration them appropriately. But i mean a slowing of this whole, a very successful pipeline from basic discovery through Clinical Trials and research. I would also add that as we are seeing a time in which critical trial results are going to be translated into common practice in the communities, we are going to have to look very carefully at what happens when a treatment reaches the community, which individuals profit most who is most at risk for side effects. And this is going to be monitoring these outcomes in a way that we havent done before. Briefly on parkinsons disease, the potential for a National Plan equivalent to what has happened in alzheimers disease, i can only project could be as extraordinarily valuable as it has been for alzheimers disease. I think you may be referring to one particular discovery of a new sensitive means for the biomarker accomplishment in parking thousands that shows the promise of detecting disease even before clinical symptoms. And biomarkers, as they have been in alzheimers disease, are very critical to identification early to monitoring the effects of Clinical Trials and to making the appropriate interventions available to the broadest diverse populations. Thank you. Just as a comment, thank you very much. I would agree, now is not the time to take the foot of the paddle but here seeing these breakthroughs that affect so many families across the country. Thank you. Thank you, chair murray. Well, thank you very much, chair baldwin and Ranking Member of capito. Um as senator collins and i have said from the start of these hearings, we are very determined to get back to regular order and make sure we pass the funding necessary to keep our families safe and healthy and keep our nation competitive. And that simply has to include providing robust funding for the National Institutes of health. If we want to continue to lead on the world stage, we have to continue our global dominance in Biomedical Research. Our nation is a Leading Light here. I should know, i come from washington state. We have many worldclass institutions, and i couldnt disagree more with House Republicans, whose proposal to slash funding would mean we will fall behind and fail to keep investing in these breakthroughs that have truly made a world of difference for patients across our country and across the globe. We have got to build on that critical progress we have been making and ensure that our investment pace, not them, as House Republicans voted to do. After a Global Pandemic that brought the World Economy to a grinding halt and cost more than one million american lives, House Republicans are seriously suggesting that we funding for lifesaving research. So it we truly care about protecting families, we need to understand that this finding is just as critical as the investment we make in our military, and we cannot forget the millions of memories who are fighting cancer and alzheimers, Substance Use disorders, long covid, and so much more. We have to make sure that our investments reflect the reality that illness is one of our nations deadliest adversaries and biggest economic and National Security threats. As i mentioned, we saw that all too clearly doing the covid pandemic, but we also saw the incredible pace of discovery with covid vaccines. There was no accident. It was made possible by our investments in research into mrna vaccines, in response to ebola, and other viruses, and by a premier Biomedical Research enterprise that we have strategically built over decades. And in the bipartisan Pandemic Response bill that got signed into law last congress, i am glad we were able to establish arpa h, to continue strengthening our capacity for cutting edge research. So i look forward to hearing from the Witnesses Today about the resources we need across the nih to continue supporting this lifesaving work. Because at the end of the day, what we get for these investments are really important discoveries that keep our nation competitive. That prepare us for pandemics and other health crises, and give families more time with their loved ones, and give patients hope for the future. It is not just worth the cost, it is priceless. So i hope we all remember that as House Republicans have now voted for deeply unserious and deeply dangerous cuts to cutting edge Life Saving Research in the senate, we need to make sure that we are continuing to fund these important and critical investments. So im glad to be here today and speak to our witnesses. Dr. Tabak, i am a huge supporter of nih, but i have to ask you a tough question today. I have been pressing nih for years about how to ensure that federal dollars are not flowing to researchers who harass or bully or retaliate against or even create a hostile environment for their colleagues. And for their students. And how to ensure nih workers themselves are not continuing to experience harassment. So i have to say that i am really appalled by recent reporting about and nihfunded scientist who faced his additional disciplinary action because he was found to have sexually harassed colleagues, was simply able to transfer his award from one university to another Research Institute where he then harassed a trainee in his new lab. And even worse, nih awarded him a new 2. 5 million grant that happened despite the fact that congress directed nih to make it mandatory for institutions to inform nih when scientists or key staff are removed or otherwise disciplined due to harassment, bullying, retaliation or hostile working conditions. Despite nih posting publicly that you require notification from all of your award recipients despite nihs knowledge of the investigations finding and i just have to say it is completely unacceptable. So i have to ask you today, what is nih doing to fully implement the requirement under last years law that sanctions must be reported to the agency . And how are you using that requirement to enforce workplace protections against harassment. Chair murray, i want to assure you that we take this issue very, very seriously. Weve handled over 650 allegations of harassment discrimination and hostile work environments. We have dedicated staff addressing these allegations and about 30 of those allegations have been substantiated in dozens of cases. The issue that you point out this morning, the so called past the harasser problem. We are well aware of that specific case. Unfortunately, the original institution was not completely forthcoming about the extent of the investigators behavior and it was only after the individuals grant was allowed to transfer to the Second Institution that we became aware of the greater severity of what the issues were. We are now working with the Second Institution to understand what the most recent allegations are. And i can assure you that, um, if, if these allegations are sustained, we will take immediate action as required. Ok. I am out of time, but i want to find out how you are making it clear to these institutions and your grantees that these behaviors shouldnt be accepted, and what youre doing to make sure that nih workers themselves are not experiencing harassment. Because at the end of the day, innovation isnt just driven by programs, it is driven by people , and we need the best and the brightest, and if this is what they see around them, we are going to lose them. So this is critical. Thank you. Vice chair collins. Thank you very much, chair baldwin. Before i turn to my questions, i am going to make a few comments. First, i want to thank each of you for your extraordinary work. In my judgment, there is no investment that pays greater dividends to American Families than our investment in Biomedical Research. And that is why ive been such a strong supporter of nih and i will continue to be one. And i think were very fortunate that all of those who are on this committee share that view including the chair and the vice chair of this subcommittee. That is why i am puzzled at the flat funding for Alzheimers Research. We have made Real Investments to help the 6. 7 million americans aged 65 older, who are currently living with the alzheimers and those who care for them. And we know that this number is on a trajectory to double by 2060. Alzheimers is also one of our nations most costly diseases and its one of the leading causes of deaths among seniors. As a senator representing the oldest state in the nation. This is of particular concern to me and as a person who lost her father, her grandfather and two uncles to this devastating disease. I know personally what this means to American Families. So i hope that we can correct the flat funding and continue the trajectory that we have been on. Now, let me turn to my question. First doctor, i want to commend the National Institute of aging. You have been essential in your institute in sustaining the progress that we have been making. And weve seen an exciting new class of treatments, one announced just yesterday that is similar to another that has been approved under the accelerated process of of fda that could delay the or slow the onset of alzheimers symptoms. In a Statement Last year following the release of phase 3 of data, nih said, although the nih did not find this started, our decades of research. The way for this alzheimers trial that notably met its primary and secondary end points. I agree. And that is why i am so frustrated that these new therapies based on sound science , approved by the fda, are not reaching patients because of cmss inexplicable determination that they are not reasonable and necessary for seniors. And heres my real concern while this is being finally sorted out. It is so sad, because these treatments are most effective when they are given early. When people are in the early stages of alzheimers. So the patients who would benefit the most are not receiving access to this medication. Doctor, in your view, what would broader access now to these diseasemodifying therapies, mean for patients . Thank you for the question. The fda and cms have regulatory authorities that are distinct from nih. But from an nih perspective, the therapies that have become available now are the clear outcome result of research supported by the nih. One of the drugs is now being studied through trials directly funded by the nih, one of which is treating individuals before any symptoms, an even earlier stage than before so called secondary prevention trial. Through these, were trying to work for exposure to more diverse populations. And in terms of what this could mean for the public, we are preparing for when final fda approvals and cms coverage occurs, to do what we can to monitor and ensure that we understand in populations that are diverse rural, urban, racial, ethnic, which are likely to differ in just which treatment and what time is best , that we have the structure in place to optimize their impact on society. This is the next stage. Having found successful interventions to, to learn from these first leads and to optimize them. So i agree with you. The impact on the broader population could be huge, and it is all Research Commitment to be prepared to assess this. Thank you. Dr. Volker, i am very concerned about the widespread use of extremely potent cannabis by our young people whose brains are still developing. Nih research has tried to better understand the relationship between marijuana use and psychiatric disorders. Given recent trends in Recreational Cannabis use and increased potency, is more Research Needed to better understand the short and longterm effects of cannabis use on Mental Health . And is nih or its grantees investigating cannabisinduced psychosis . Thanks very much for that question. Yes, we are very concerned about the increased use of cannabis with very high content of thc. What were seeing is an increase in the number of people using cannabis regularly at very high doses. This is particularly important because it is the high doses that are associated with psychosis. It is very important area of research to try to understand under what conditions the use of marijuana can be can result in psychosis. We are prioritizing this as an area of research to unequivocally determine if there is a causal link between the use of cannabis and psychosis. Researchers are also investigating the potential role that cannabis use can have in suicidal behavior. We need to understand what may be the consequence, or not, of the use of cannabis. We should be concerned and sent and certainly monitoring the threats. Sen. Collins thank you. Chair mary senator durbins. Sen. Durbin s thank you. I would like to address an announcement this week in chicago from Northwestern University. There was a breakthrough in their Research Related to the brain. And it has a personal element to it. We lost two of the pillars of the United States senate to brain cancer, senator kaine and senator kennedy senator mccain and senator kennedy. I understand treatment is limited by and large to surgical intervention because of the blood brain barrier i will stop trying to seleka ever sound like i ever attended medical school. [laughter] knew that but in reading the news account of this Northwestern University breakthrough, it appears that they have now opened the blood brain barrier to allow drugs to pass through to the brain, meaning that unusable chemotherapy drugs can now reach brain tumors. So there is an option beyond surgery, or there could be soon. I will not go any further to try to describe it. But it also said in the article, that this could have an application and parkinsons as well as alzheimers. Would someone please comment as to whether this was an nihfunded Research Project, and what the process could be . Senator, i dont know the answer to that, we will have to get back to you on the record. Certainly, it is a breakthrough. We will get back to you directly, sir. Sen. Durbin second point i would like to raise, people said to me, if you ever get nih in front of you, ask them why they arent putting more money into Mental Health research. I noticed in your Opening Statement you talk about precision medicine. But when we look at the scourge of Mental Illness in this country, particularly as it affects young people now in extraordinary numbers and percentages, could you give me a point of reference as to how much is being invested in Mental Health and in Mental Illness, as opposed to physical illness . Dr. Gordon can answer that question, sir. Dr. Gordon we are talking strictly dollars here, the nationals Mental Health budget is about 2 billion. There is a couple billion dollars more in aaa. But of course, the crisis isnt about dollars, its about people. We are in the midst of a national Mental Health crisis and we have to respond. You noted in particular two priorities that we are highlighting in our Research Response and they are highlighted by the president and the unity agenda precision psychiatry and youth Mental Health. On the precision of psychiatry space, we know that we need to do a better job in psychiatry in matching patients with treatments. And we also know that we are on the cusp of being able to do for Mental Health, at least for some parts of Mental Health like depression and schizophrenia, what the nia has done for alzheimers, that is developed and proved that biomarkers can be used to help guide medical decisionmaking. So in the president s budget, we are proposing two large initiatives. One aimed more generally at Mental Health, and one aimed at depression. On the youth Mental Health space, we know from studies what to do, but we need to do a better job of figuring out how to implement things like Suicide Prevention programs and Mental Health prevention programs and Early Detection and early prevention treatments for psychosis in youth, in schools, through digital health, and through other settings that we know can reach children. Those are two of our priorities. Sen. Durbin many of cities across america face what chicago faces with gun violence, particularly from young people. I went to the cook county juvenile facility where teenagers are being held waiting for trial of many of them accused of murder. They spend 1 to 3 years in this building. They have created a high school in this building for teenagers. It looks like a regular high school inside, with a gymnasium, cafeteria classrooms and such. And when i asked the counselors, what do you find when you sit down and talk to these young people who are on trial for murder and accused of gun violence . They said, well, we find the full menu of Mental Illness, but the one recurring theme is trauma. They have been exposed to trauma in their lives that it has really changed the way they look at the world. Senator capito and i have a bill on this issue looking at trauma. It just seems to me that when we talk about youth Mental Illness, this is the most obvious frontline challenge that we face. What should we be doing now that we are not doing when it comes to trauma . That is 100 correct. Trauma is at the root of much Mental Illness, not only in childhood, but in adulthood as well. We need and we know we need to do a better job of building resilience to trauma. One of the earliest findings and Trauma Research was that successful navigation of trauma in childhood can lead to resilience to a range of Mental Health consequences later in life. That has been the focus of Much Research at nih, and it really needs to be the focus of implementation. Moving forward. Sen. Durbin i would just say in closing that ive been proud of the subcommittee and what its achieved in terms of funding for nih research. The 2 figure sent to us by the administration is a true disappointment i am going to tell the president is much and the idea that the republicans have suggested in the house of a 2025 cut in nih funding is scandalous. Thank you, mr president. Chair murray thank you. Senator moran. Sample moran thank you. I wish you and the Ranking Member well. And we will pledge to be a good member of the subcommittee to see that we achieve good results at nih and other thing one of the examples of not in every instance, if you spend money, do you necessarily get a better result . But there is plenty of evidence that at nih that does occur. And doctor, i would highlight particularly the increasing total amount of money. So, doctor, i highlight that to you and what has happened. But in the area of alzheimers, i think weve seen significant difference, and perhaps you can tie it to the Additional Resources that this subcommittee and this congress has provided to nih, i would be happy if youd like to confirm that more resources do make a difference. Id be happy to confirm that they have made a difference. The enormous progress weve seen could not have happened at this pace without the increased support and investment in research. And similarly, well do our best to continue the momentum of this with whatever resources are available. Could you put that in personal terms . What it might mean for a family or an individual who has been diagnosed with alzheimers . Well, i think with a reduction or limitation in resources, we would do our best, of course, to be good stewards of resources we have. But inevitably, it would slow the progression from most basic discovery through the identification of new diagnostic, therapeutic and preventive measures. We havent spoken as much about prevention as we have of treatment. But thats another one of the very High Priorities in which weve made great progress, that continuation of which is going to be dependent upon resources. Thank you for the reminder about prevention. I chair the down syndrome caucus in the senate, and one of the things that i appreciate is the opportunity, we have one of the institutes that have a role to play in that research. The relationship between down syndrome and alzheimers is still being developed and understood, and hopefully providing information and a path forward. Anything that i ought to know, maybe about whats going on in the realm of down syndrome and how our caucus and my colleagues and i can be helpful in not only in the research thats going on but in assistance to individuals and families. Well, with the continued leadership and support of the congress, we have expanded our work with individuals with downs syndrome. For example, the include initiative, which stands for investigation of cooccurring conditions. As you know, people with down syndrome are more susceptible to certain types of disease and are less susceptible to others. And so, there is something to be learned for the general population as well as those with down syndrome. We are, in particular, trying to enroll more people with down syndrome in typical Clinical Trials, so that we have a better understanding of what interventions that we use for the general population would have on individuals with down syndrome. Youve already alluded to the intersection between down syndrome and alzheimers disease. And of course, doctor hotis is best prepared to speak to that specific point if you are interested. Let me suggest to you that if nih would provide us, provide me with information about how to encourage additional individuals with down syndrome to participate, wed be glad to take that on as a project in educating our constituents of it would be beneficial. We really appreciate that. And we may suggest that we have a down syndrome caucus meeting in which we pursue that and other issues that are going on. Thank you, doctor lowy. I raised this issue a year ago and i want to highlight this again. Im concerned about the competition that will occur for Cancer Research funding. So we have funding at the advanced Research Project agency arpaa. And i wanna make sure that it doesnt come at the expense of basic Clinical Research at nci. We also have arpa h and the cancer moonshot initiative, and im looking for a commitment by you and by nih that there will be a prioritization at the nci competitive cancer grants will be funded in fy24. Senator moran, thanks to you and the committee and the long term strong support, we were able in fy23 to increase the pay line for our large awards from the 11th ile to the from the 11th percentile to the 12th percentile. This will mean more than 100 additional grants than we were able to do in 2022. It is still not enough. As you know, there has been tremendous opportunities for Cancer Research, and so researchers are flocking to the nci in large numbersm larger than in other areas. And therefore, although were supporting many more investigators than we did previously, our pay lines or success rates are not where they should be. Turning to your specific question about these other entities, i can assure you that we interact regularly with them. For example, with arpa h, the doctors who are the head of arpa h meet regularly. But we also are communicating directly with various possibilities of research that could be conducted by arpa h versus research that would be more appropriate for nci and to work collaboratively and together to make this a reality. Thank you, chairman. I wish that dr. Collins was here to hear dr. Lowy say that researchers are flocking, flocking to the nci. And i would look at that photograph of this young lady whose grant wasnt adopted and she was leaving the ending her career in research. She was ending her career in research. It was something that captured me a long time ago on this topic about individuals that we lose when the moneys not there. Thank you. Senator shaheen. Thank you madam chair and senator capito for holding this hearing. And thank you to all of you for your work every day and for being here. Doctor, youve been to new hampshire, you know what a challenge weve had in my state of dealing with the opioid epidemic. 2022 was the worst year for Overdose Deaths since 2017 in our state. And i understand that in your testimony, you discussed the important work of the heel initiative. Can you talk about whats being done to address vaccinating individuals against Substance Use disorders and what other promising medications you are seeing . Yes, thanks very much. And indeed, the funds from the Hill Initiative have enabled us on the one thing, for example, to expand very much the Medication Development pipeline and that includes development on research on vaccines and monoclonal antibodies. So there is Ongoing Research on different strategies to develop vaccines that are targeting fentanyl, oxycodone, heroin, or multiple drugs at the same time. In parallel, we are investing also significant amount of resources to get monoclonal antibodies, because those will be able to deliver high higher titles. To deliver higher titles. These interventions are targeted the monoclonal antibodies to help prevent and reverse overdoses from fentanyl, as well as with drugs with other drugs. In terms of investments, we have a whole pipeline that goes from repurposing of medications that may be useful to result in Better Outcomes for the treatment of opioid use disorders, as well as completely novel targets that will be able to help people that are addicted, not just to opioids, but to multiple substances. That is, they go at the basis of the molecular mechanisms, links with addiction. Also an area that i think extraordinarily exciting is of the utilization of neuromodulation, by which we can actually strengthen or weaken certain circuits or hops in the brain that are found to beociated with addictive behaviors. And there, many of the developments that have enabled us to go increasingly more precisely are part of the brain initiative, which is another brain fundamental. How about methamphetamines . Methamphetamine . The we dont have any medications that have been approved by the fda. So it is a major priority for us. What things got me very excited . Currently, we are doing Clinical Trials, phase one and four vac monoclonal antibodies against methamphetamine, because we dont have anything to reverse an overdose. But were also working on vaccines for methamphetamine. We are also doing research in terms of Clinical Trials, taking advantage of medications that when combined, have already shown to be beneficial in reducing craving and withdrawal. So this is an area that requires again investment of research and partnerships with industry so that we can bring these developments and translate them into the clinic. And are we talking about five years, 10 years, beyond that, in terms of having something that we think is gonna actually be marketable . I would actually like to say that there are some lower hanging fruits like the repurposing of medications where i would hope that we could have them in the clinic, if the fda approves the indications, say within five years. For the issue of monoclonal antibodies or vaccines, this is a completely new adventure, and there is no precedent of approval by the fda for vaccines or monoclonal, which is likely again to result in a longer trajectory to get them from the research. Now they are in humans, some of these into the clinic. But theres also an area where we are investing in that and that is the use of devices and that is in, enables us to translate products much faster because the level of safety that the fda requires is much lower. So we are investing on multiple roads to get more rapid and then also in the long term and things that can be transformative. Well, thank you very much, appreciate your work doctor. Id like to switch to another illness. Senator collins and i have been we chair the diabetes caucus in the senate and weve been looking at how we can continue to support the research to address diabetes. And i understand that right now we have beta cell and stem cell derived islet replacement therapies that are actually showing promise for cures. My daughter told me she had been to a conference where she met a man who had benefited from that therapy. He had been diabetes free for three years. Can you talk about what nih is doing to support that and any challenges . I understand also that fda has been an obstacle in getting approvals. Can you speak to that and what we need to see from fda . In order to see this research actually bear fruit. We dont view them as being an obstacle. Thats my term. But certainly, certainly we need to partner with them. The challenges are to protect the newly transplanted islet cells, regardless of what their origins were, from attack from the human immune system. And so, were using different approaches. For example, were encapsulating them as a barrier. Were also trying to genetically engineer the islet cells so that theyre not recognized as being foreign. These are the types of approaches that will take things to the next level. But, as you point out, the findings are very, very promising. So that we can actually see a cure in the foreseeable future for diabetes. The results are very promising. Thats ok. You dont have to repeat that, i can use that. Thank you. Thank you. Senator schatz. Thank you very much all of you for being here. Doctor gordon, i dont have to tell you that were facing a youth Mental Health crisis. The Surgeon General has called out a link between this crisis and social media use and said that 13 year olds are too young to join social media. Last week, i introduced a bipartisan bill with senators cotton and britt and murphy to empower parents and protect kids on social media. Nih has recognized these risks too and you are requesting an additional 20 million to continue to study the impact of social media on children. I know that correlation and causation are not the same thing, but does the spike in Mental Health challenges in kids correspond with increased social media use . First, there has been a spike. I actually wouldnt call it a spike. I would call it a mountain with a slope that really started five years ago or more. Increased rates of suicide deaths in children, increased rates of depression and anxiety. So its there, no question. And certainly the covid pandemic has played a role, and there is evidence to suggest that social media can be a harm for childrens Mental Health. Theres been a number of studies funded by nih, including nida, nimh, kennedy shriver, nationals of child health and Human Development, which have shown some of these negative impacts. Adolescents, for example, who discussed self injurious behaviors through social media were more likely to have a suicide attempt. Adolescents who place higher levels of importance on social media use and self image report higher levels of depression symptoms. The list of findings goes on and on. It is important to recognize though that social media can also be leveraged for positive impacts on Mental Health. For example, customized, moderated social media platforms have been used to effectively deliver a wide variety of social supports and Mental Health treatments. Because my time is limited, first of all, i agree with everything you said and thank you for that. Im gonna reduce one question to the record, which is how you use the 20 million in the president s budget. But i would just point out that yes, it is. There are plenty of beneficial uses of social media, especially for kids who are feeling alienated. But there are, in my view, no beneficial uses of the predictive algorithm that boosts content into peoples brains, especially childrens forming brains. And lets just take one moment to understand the Business Model. The Business Model is engagement equals revenue. And the algorithm has discovered that the way to get engagement is to upset kids. So, publicly traded companies have a fiduciary obligation to run an algorithm that is systematically upsetting generations of children. And so, we shouldnt wonder why this is happening, this is happening. It is true that kids can find affinity groups and learn things. And, you know, my kids certainly learned to do arts and crafts and fix bikes, and theres all kinds of cool stuff on social media. But none of that is coming from the predictive algorithm. All of that is coming from the search function. So i just wanted to make that kind of technical point. Doctor, one of your priorities is to reduce Health Disparities and to build a diverse workforce. I was disappointed to see that the budget request makes no mention of the native hawaiian community, even as native hawaiians face 14 fewer years of healthy life than other groups. What can i do to increase the representation of native hawaiians as investigators in Community Based research . Well, one of the approaches of course is to launch studies that seek to understand the nature of these disparities in the health communities. We recently announced the funding opportunity announcement for native Hawaiian Pacific islanders. Thats a collaboration to support a Population Based study to look at the key health gaps. And were committing about 44 million over the next several years. Getting studies of this type into the communities often will attract people from those communities to participate. And thats sort of an on ramp, if you will, into health based careers. So thats one approach. Thank you. Doctor volkoff. 60 years ago, the u the United States was producing research on psychedelics as therapy for addiction, chronic pain and Mental Illness. This, as you know, this research was cut off as a matter of public policy, as part of the war on drugs. And i know that there has been a pivot to sort of relook at these not to make an assumption that any of these things are medicines, theres a process for that determination. But i think all of your agencies are now starting to relook at the potential therapeutic benefits of some of these pharmaceutical substances that have now been made contraband and used almost exclusively, you know, as illegal recreational drugs. Can you provide us an update on where we are on Psychedelics Research . Yeah. Thanks very much for this question. Psychedelic research effectively has halted for many years, and as the evidence is starting to emerge, that shows significant potential in terms of therapeutics for certain conditions like severe depression or post Traumatic Stress disorder, and also preliminary Research Showing benefits for the treatment of addiction, we are actually engaging the Scientific Community to try to understand how basically psychedelic drugs can be potentially utilized for the treatment, how they affect the brain, and also how to deploy them in ways that are going to be safe and very effective. So this is an area of great interest. Both nimh and nida are partnering in trying to expand and accelerate. Thank you. Senator bozeman. Thank you, madam chair and senator capito, for this really important hearing. And thank all of you all for being here and just the great work that you do and the remarkable careers that youve had through the years. Doctor larry, the university of arkansas for medical sciences, and little rock has been doing incredible work expanding its Cancer Institute and working towards applying for n c i designation. Applying for nci designation. As you know, there are 71 nci designated Cancer Centers in 36 states, 36 states across the country. With the closest to arkansas being in memphis, pediatrics only, dallas and oklahoma city. Nci designated centers receive a large majority of the available funding for research and Clinical Trials. Giving them a unique advantage over non designated centers. Its critical for all areas of the country to have access to quality Cancer Research and Clinical Trials. What are the ncis plans for supporting nci designated Cancer Centers in areas in the country where there are none such as arkansas . Senator bozeman, thank you very much for this question. As you point out, there are 14 states that do not yet have designated Cancer Centers there to some degree. This is compensated for by some of the designated Cancer Centers having outreach beyond their states, for example, the university of utah and wyoming just as an example. But arkansas is one area where it would be wonderful if the university of arkansas Cancer Center were able to meet the requirements that nci has for nci designation. And our office of Cancer Centers has interacted with the Cancer Center as recently as a couple of months ago. We would really welcome the possibility of the arkansas Cancer Center coming in with for coming in for this important area. While waiting for that, its important to recognize that nci supports other parts of the cancer Research Enterprise such as the Community Oncology research program, which has more than 2,000 areas or places where people can enter Clinical Trials including in arkansas. Thank you. We appreciate that, and we do appreciate your help, and you all have been really good and helpful in getting us where we need to go. One of the problems that weve got is with the finding enrollment for Clinical Trials. Arkansas, 41 of the population is rural, and so that makes it just that much more difficult. The budget request includes a 500 million increase for the cancer moon shot with one of the goals of the funding being to boost recruitment and Clinical Trials nci sponsors and or supports. What can we do to do a better job of accessing cancer trials in Rural America . How can we help you . Senator bozeman, this is a very important issue, because there are so many parts of the United States, not just arkansas, where rural populations are even at higher risk of developing cancer. And unfortunately, over the last 20 years, although mortality rates for cancer has gone down for people in rural areas, as well as in urban, the rate of decrease now is slower for people in rural areas compared with urban, and nci has had a number of meetings in the very near future, we are going to be providing Research Awards for areas of chronic poverty, which are one of the potentially rural areas which are have particularly high incidence and mortality from cancer. One of the good news, one of the few areas of good news for the pandemic has been the expansion of telemedicine and also the streamlining of Clinical Trials to make it easier for people in rural areas to enter and participate in those trials. Thank you, sir. Well, thank you, and we do appreciate those efforts and anything we can do to help you. We would be pleased to do so. We look forward to visiting with you. Thank you all again very much. Thank you, madam chair. Thank you, senator kennedy. Thats fine. Thank you, sir. [indiscernible] i think nih is an extraordinary institution. You and your colleagues, your work is breathtaking. But i wanna ask you about one of your programs, in 2020 you created a program called the faculty institutional recruitment for sustainable transport transformation. And basically under the program you gave 12 institutions 241 million. A lot of jack in anybodys book. You directed the grant applicants to use the money to demonstrate a strong commitment to promoting diversity and inclusive excellence when you hire people. Ok. And two of the institutions to which you gave money, one was university of South Carolina to hire faculty members in Public Health and nursing. And the other one was the university of new mexico, to hire faculty members in neuroscience and data science to great institutions. Neuroscience and data science. Two great institutions. South carolina and new mexico issued rules to administer the money that you gave them. And they both said that we are going to punish candidates who apply for jobs with us with this money that you gave them who espouse race neutrality. In other words, both of those institutions said, were gonna give a very low score for anyone who states an intention to ignore the varying backgrounds of their students and treat everyone the same. So, they took your money, and they said, were hiring faculty members, and any applicant who says, we dont believe in this, in racial prejudice, we think everybody ought to be treated the same gets an f. Did you know that . Im not familiar with the specifics that you are mentioning, senator. Would you look into it . I certainly will. This program is an important effort to create a more highly diverse workforce. I agree with that. Thats a good idea. Do you know anybody against diversity . Unfortunately, sir i dont. Ive run across a few over the years. Im sure theres some out there, but i think most fair minded people agree with. Our effort is to create an environment where people from all backgrounds in, in every different dimension would, will be safe and welcome to conduct high quality biomedical that. But heres what im getting at. Do you think its fair for the university of new mexico and the university of South Carolina, two extraordinary schools, to say to an applicant whos borrowed hundreds of thousands of dollars to get her phd, and who comes forward and they say, how do you feel about race . And they say, i believe in racial equality, i believe everybody should be treated the same. They get an f, theyre dismissed summarily. You think thats fair to do that with your money, with taxpayer money . Again, sir, i cant speak to the specifics of these institutions and i will look into it. Do you support that . Id have to see what exactly it is. But if its true, do you support it . What we are trying to do, sir, is create inclusive environments, because unfortunately, far too often, certain individuals do not succeed in obtaining faculty level positions at universities. But if i hire somebody, so suppose can i as an american, legally, constitutionally, morally say im only going to hire Asian Americans . Anybody else of any different ethnic background need not apply. Is that moral . Is that constitutional . Im god knows, im not a lawyer. But you are a human being. To get to a faculty level position is a multi step process and very often highly qualified candidates are never even considered because of where they trained, where theyre from or what they look like. But do you think none of that is fair . I dont think youre answering my question. Do you think it is right for an institution using money that you gave them to say if you believe in racial equality and you say you want to treat everybody the same, saying a big old hook comes out and around their neck and pulls them off the stage and they say youre not gonna be, do you think thats right . I just dont, i would need to understand the context, sir. And i really dont know what these institutions are saying to candidates, and i will certainly find out. Well, im gonna follow up. I want to know. Thats how they spent taxpayer money that you gave them and im gonna follow up, and i wish you would, too. This disturbs me, because i dont think thats lawful. We will certainly get back to you, sir, with what we find. Thank you, senator kennedy, senator britt. Thank you, madam chairman. I wanted to talk today obviously about the crisis in this nation with regards to Mental Health. When you look at what is happening, it is clear that nih has also identified this crisis as being one that is plaguing communities across this great nation. The white house in 2023, the Mental Health research priorities, those even showed they speak to digital platforms in terms of their effectiveness to treat mental and Behavioral Health outcomes. However, there are plenty of nih studies that show how social media and screen time likely have a negative effect on Mental Health, particularly youth Mental Health. Now let me tell you something, as a mama of a 13 and a 14 year old, this is something that is particularly important to me. I look at how young people are having to grow up right now. I know as someone who went through middle school and high school as a young woman, that its tough. I cant even imagine the additional pressures that they feel, given having a screen at their fingertips all of the time. I think the reports are shocking, and i dont think the numbers lie. Last year, one in three High School Girls said that they seriously considered suicide, and actually one in nine, or almost 9 , 1 in 10 High School Students reported actually attempting suicide in the last 12 months. Folks, i ran for the senate as a mama on a mission. I said that my children and other peoples children and grandchildren should be able to achieve the american dream. If we do not take a hold of what is happening right now with social media and our youth, it is going to be so far gone, we cannot get it back. And my question to you is, what is the nih doing to address the damage of social media and what is happening on our children and our childrens Mental Health . So senator, on a personal level, i have a grandson whos the same age as your children. So i completely understand, if i may turn this to doctor josh who is the director of an age to answer you specifically. Thank you. I have children who are 20 and 25 who grew up with social media and saw them wrestle with it and the challenges theyre in. I can absolutely. I think if you look at the correlation, from 2011 to 2019, the cdc says that depression amongst our children, our High School Kids more than doubled. It is no coincidence that that actually coincides with the exact time where we had a rise in social media. For that matter, not just depression, but suicide deaths have been dramatically increasing in children and children who are even younger than used to typically die. So were seeing dramatic increases in the rates in preteens, which is incredibly disturbing. So, what are we doing about social media and Mental Health . We and the National Institute of child health and Human Development both have programs and understanding the impact of social media. And importantly, looking specifically at what aspects of social media use correspond with negative outcomes from a Mental Health perspective and trying to figure out how we might intervene and especially trying to support families and parents and working with children to figure out how to how to avoid the negative consequences of social media and how to regulate social media, youth, at the family level. So we have a range of different programs in this research that weve been supporting with specific dollars that have been appropriated by this subcommittee in the past. And we will continue to support that work. I hope that you will all continue to work on this to pay close attention. Our children are counting on us. I want to follow up on what senator schott said earlier. We have introduced a piece of legislation along with senator cotton and senator murphy to help with this. Its bipartisan, it prohibits children from under the age of 13 from using social media, which is consistent with what social Media Companies say that they already do. It requires a parent or guardians permission for children ages 13 to 17 to create an account. So, very simple. And the last thing is it requires social Media Companies to verify that quickly. But it also doesnt not allow them to utilize algorithms against our children. So between 13 and 17, when theyre on social media, they would not be able to be targeted by algorithms pushing them into what we know to be so many deep dark holes. And so, i am hopeful that this body will act. I am hopeful that we will come together and actually do something to put parents back in the drivers seat and to protect our children. I will tell you, they are counting on us. Thank you. I yield my time. Thank you. We will begin a second round, hopefully quick and painless. So, i wanted to start where i left off with you, doctor volkoff. In march, the Drug Enforcement agency announced it had detected a drug called xylazine in nearly a quarter of all confiscated fentanyl in 48 states. The combination of these drugs have proven to be very deadly, but the tools that we have to combat fentanyl overdoses like the test strips we were talking about and naloxone may not help us in this situation. So i wonder if you could talk about the impact that xylazine has on the medicines that we use for overdose reversal and how nih research is adapting to new and deadly ingredients that are being added to opioids. And it seems like, you know, every other day, we hear about a new challenge with regard to either additives or things that are harmful in different ways. Can you talk a little bit about xylazine, and how how youre adapting your research . You know, and its a very important problem that has grown actually very, very fast, i would say in the past three or four years. So the first thing that we need to understand is why more and more of the drugs, particularly fentanyl and heroin were sold mixed with xylazine. And what it appears to be happening is that it basically expands the duration of the effects of fentanyl or heroin. So it allows the dealers to actually basically create a product that has a characteristic that may be more reinforcing and therefore of greater value. Its become very challenging, because whereas naloxone serves to reverse an overdose from fentanyl, the responses when you combine these two drugs are not the same. So Current Research is ongoing to try to determine both in animals and in human and animal models and in humans what should be the optimal target to try to prevent the deaths associated with a combination of fentanyl and xylazine . They act by very different mechanisms. Fentanyl inhibits respiration and breathing. So you dont have oxygen in your blood, but zylazine also by a different mechanism that doesnt engage the same receptors is decreasing oxygenation. So you have when you combine these two, two mechanisms that are deal are are exacerbating the outcome, which is why in some instances that use when you use a naloxone narcan to reverse the overdoses, you dont get adequate responses. And research is ongoing to develop therapeutics that can actually help in those overdoses. Thank you. Doctor tayback, i was proud to author the next generation researchers act with senator collins to improve nih 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 . And im proud of this progress, but theres still a long way to go. The average age of the first time r1 funded investigators remains 42 years old today. Today, more than twice as many r01 grants are awarded to investigators over 65 than to those under 36 years old. In the 1990s, those figures were reversed. So we all know that diversity in the biomedical workforce leads to research innovation, Higher Quality work, and more participation in Clinical Trials by people from underrepresented groups. Yet inequities persist. And a study published in february shows that whenever there is an uptick in nih funding, it creates more inequity. Women and people of color face increased barriers, and an uneven Playing Field to obtain funding. So, doctor tayback, tell me how nih is working to support more early stage investigators, including women and those from diverse backgrounds. Well, thank you for your leadership in this area, and certainly, we have made some progress, but as you point out, a ways to go. Our target has been a minimum of 1100 new early stage investigators each year. Last year, we were able to fund over 1600, which is the good news. But youre quite right. Those who already have support have advantage, its just that simple. So we have set up some additional programs which we hope will level the Playing Field. For example, there is the cats award, where no preliminary data is required for the application that may seem counterintuitive. But in fact, what it does is it liberates the applicant from the work of their former mentor, their former phd advisor or post doc advisor, so that they can come with their best ideas and dont need to have enormous resources to create the preliminary data thats needed. So you really can just support things for a great new idea. We have the nih pathway to independence award. Its the skip the post doc award. You go right from graduate school into a faculty level position. Its not for everybody, but there are talented people out there for whom this is just an ideal circumstance. We are also looking at the nih directors new innovative award program, where of course, we are trying to incentivize young people with great ideas to come into our system. And this is gradually bringing in people from outside of the traditional Biomedical Research disciplines. The good news about this pool of early career investigators is they are enriched for both women and people of color. There are more young people of color, there are more women in this early stage cohort than in the general cohort. And so, if we keep pushing to fund more and more of these early career investigators, we are gonna see a shift in that right direction that we all hope hope to achieve. Thank you. Senator capito. Thank you. I want to ask about arpa h. In fy 2023 omnibus, there was 1. 5 billion for arpa h and moved under the nih umbrella. And then this new budget is asking for an additional billion dollars. Im supportive of the goals of apa h to be high risk, high reward partnering with the private sector. But i dont really understand why arpa h is going up a billion. And yet most of the other Biomedical Research being done at nih is pretty flat. Funding slight increases in some places. Can you describe how nih and arpa h can complement one another, your perception of this . And where is arpa h fitting into the into the Overall Organization . Arpa h is an independent entity within the nih superstructure. They have taken advantage of a number of our Administrative Systems so that they dont have to reduplicate, you know, sort of basic Business Systems and things of this nature. The inaugural director, doctor wegerson, has been putting together her team. Theyve been on boarding over 100 folks now. The key to their Business Model, if you will, is the recruitment of Program Managers who have who come with them unique ideas for bold and creative projects that they would like to see supported. They have been sorting through some 250 candidates. Thus far, they have hired a few to begin with. Theyve just recently released a Broad Agency Announcement for research to improve Health Outcomes across patient populations, communities, diseases and health conditions. The arpa h leadership has been engaging with the rest of the n the rest of the nih leadership on a regular basis. We certainly want to avoid duplication or we want to in incentivize shared engagement with one entity doing one aspect of a problem and the other entity doing another. This is a bold new idea about how to fund Biomedical Research, we think will complement what we do at nih. And were looking forward to continued to work with her and her colleagues. Well, i would hope, you know, the complimentary aspect of it certainly. And we see all the expertise on the panel and all the folks behind the expertise that we see here today. It certainly makes sense. So well watch that as it fully develops and thank you for that explanation. Last week, the republicans on energy and commerce launched an investigation into the nih use of Public Relations and Communications Services worth about a billion dollars since 2018. Contracts to 10 Public Relations companies. As i was reading this, i was thinking, wow, thats a lot of money, and thats, you know, for 10 companies, thats a lot of money. But then when i started thinking about the years and the fact that it had initial funding of 500 million and then was doubled to a billion under covid, the covid pandemic. And you and i talked about this on the phone. You know, theres a lot of people have moved through covid confused as to the best way to have achieved this, the best way to cope with it. You know, youre seeing all the second guesses. Should we have closed the schools . Should we not have closed the schools . Is it contagious . Can i get it from touching this . All the Different Things that we went through during that period. I guess i have a two fold question. First of all, i dont think we got our bang for the buck for nih spending this much money in Public Relations because i think the confusion is a partially owned by nih and other health. We can look at who else owns part of this. Weve never been through this. We dont really know. It was 100 years ago, the influenza of 1918, you know, might have had some similarities, but we cant sit here and say this is never gonna happen again or could never happen again. So i guess my question is, as you look first of all, will you keep us keep us here at the senate, the subcommittee in the loop as to what that investigation uncovers with the vast amount of dollars there. Yes, thank you. The other thing i would say is what is nih doing to do a look back in this area . Im not talking about Vaccine Development or anything like that. But of communicating to the American People how you can improve that part of the reaction to covid, and its gonna play into long covid and Everything Else as we move forward. So, are you all doing a full analysis of what your reactions were . Are you gonna make that public . When can we expect to see that . As you well know, our mission is to translate and communicate Research Findings in a way that is understandable to all of our stakeholders, patients, families, health care providers. And again, its all done with the goal of improving health. So we are taking a look back to see in a formal way . I think it will become more formal, but initially, we are doing the landscape. We cant make excuses and we have to own how it came up. I accept that. But of course, we were dealing with something that was ever evolving, and learn more, your message can be more and more precise. We are looking back to try and figure out how things might have been done better with an eye towards what happens the next time, because youre right, there will be a next time about something. There will be. If we look at like doctor volkoffs area of expertise, it, it was thought initially, oh, well, if people can do telemedicine in this area with their, and then you saw the numbers go up. So maybe that wasnt true, you know. It had a whole different dynamic. You look at Mental Health, huge issues there. So i think weve got to do a really deep down analysis, but i think we really need to. You all are doctors and thank goodness who you are, but sometimes we need to communicate in plain language, what is actually going on and what you need to do and you can play a big role here with all the research. So thank you all very much. Thank you. So this will end our hearing today. I want to thank all of our Committee Members who attended for their thoughtful questions and thank you to all of you for being here and sharing your expertise with us today for any senators. Your expertise with us today. For any senators who wish to ask additional questions, questions for the record will be due on may 12 by 5 p. M. And the hearing record will also remain open until then for members who wish to submit additional materials for the record. The committee will next meet in this room, dirksen 192 on tuesday, may 11th at 10 am for a hearing on the biden administrations budget request for the department of education. And until then, this committee stands adjourned. Thank you all. [captions Copyright National cable satellite corp. 2023] [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. Visit ncicap. 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