[inaudible conversations] thank you all for being here in the Senate Committee on health education, labor and pensions. We will come to order. This morning we will be considering the nomination of doctor Monica Bertagnolli to serve as the National Institutes of health director. Let me begin by welcoming doctor bertagnolli to the committee. We look forward to hearing from you and we thank you for being here today. I see you brought along a fellow from wyoming and we welcome senator barrasso as well. The nih with a budget of more than 47 billion is the largest funder of medical research in the world. This research has led to new treatments and Prescription Drugs that are significantly improved the lives of americans and people throughout the entire world and i think all of us every single american should be very proud of those accomplishments. Having said that, let me say a few words about my concerns. I dont have to tell any american that the Healthcare System in our country is broken and it is failing. We spent almost twice as much per capita on healthcare as any other industrialized nation yet we have 85 Million People who are uninsured or underinsured. We dont have enough doctors, nurses, dentists, Mental Health specialists. Our Life Expectancy is lower than other major countries and is actually in decline today and very relevant to the hearing that we are conducting right now. We spend as a nation the highest prices, we pay the highest prices in the world for Prescription Drugs in some cases ten times more than the people in other nations. While the largest Drug Companies made over 112 billion in profits last year and paid their ceos exorbitant compensation packages, one out of four americans cannot afford to pay for the medicine they need and thousands of families face financial ruin as they pay prices that they cannot afford for the Prescription Drugs that keep them alive. Think about it for one second millions go to the doctor, the doctor writes a prescription and they cannot afford to fill the prescription. How insane is that . But its not just the high cost of Prescription Drugs impacting individuals. In the largest hospital in my state in vermont and i dont think that its different elsewhere, the high cost of Prescription Drugs account for 20 of the overall budget for the hospital and that drives costs up as well. Prescription drugs impact hospital costs big time. In other words, the outrageously high cost of Prescription Drugs in america is a crisis and it must be addressed. Adding insult to injury not only has the federal government not effectively regulated the price, but the taxpayers of this country have over the years provided hundreds of billions of dollars in research and development into new Prescription Drugs that have provided financial benefits to some of the most profitable pharmaceutical companies in the world. In America Today the median cost of new cancer drugs has gone up more than 300 over the past decade even though 85 of the initial foundational Cancer Research is funded by the u. S. Taxpayer. We are putting money rightfully so into research to deal with cancer and yet we pay outrageously high prices. In june the committee released the report that found that the average price of new treatments that the nih scientists helped event over the past 20 years is 111,000. In virtually all cases american taxpayers are paying far more than people in other countries for the exact same medicine that the nih and taxpayers helped develop. Here are just a few examples from this report. They charged over 165,000 for expanding while the exact same chart can be purchased in japan for just 20,000. This is a drug developed by american taxpayer dollars. Johnson johnson charges americans with hiv 56,000. While the same treatment can be purchased in the uk for just 10,000. A product developed by u. S. Tax dollars. Gilead charges americans with nonhodgkins lymphoma 424,000 on the exact same therapy purchased in japan for just 212,000 and the list goes on and on and on. We pay for the research. The Drug Companies develop the drugs, make billions in charge the highest prices in the world for the product. One last example. After receiving 12 billion from the federal government, theyve quadrupled the price of the Covid Vaccine that was literally coinvented by nih scientists 128 for the exact same medicine, same vaccine will be available in europe for as little as 26. Anybody here think that makes sense . We develop the research, we pay for it, the highest prices in the world, doesnt make sense to me. In my view at this very difficult moment for American Health care and we are in a crisis situation we need an nih director who is prepared to take on the pharmaceutical industry and use every tool at his or her disposal to lower the outrageous cost of the Prescription Drugs. The 1800 well paid lobbyists from the pharmaceutical industry all over this place may not be happy about that but that is precisely what the American People want. The status quo is not working. We need fundamental changes from the way they address the crisis of the Prescription Drugs. We need nih directors who had to reinstate and expand the reasonable pricing clause to make sure the Companies Set reasonable prices for the drugs developed. A whole lot of things the end of the nih alone are their agencies there agenciesthe administratioe active as well. At the media describes what goes on in congress as we are a divided nation. But i will tell you this whether you are a conservative republican, progressive, democrat or independent, you know what we all agree on is the American People want to the congress to deal with the outrageously high cost of Prescription Drugs. Senator cassidy. Thank you, chair sanders. The Committee Considers the nomination of doctor Monica Bertagnolli to be the director of the National Institutes of health. Thanks for being here. Thanks for taking on this job and going through the committee that i know must be stressful but again very pleased to have you. You have an incredibly impressive resume and i say that is at the physician who was formerly an academic but has no resume that compares with yours and its reflected by the support you have in the scientific community. Theres no question regarding scientific qualifications but there are people that will ask questions regarding the overall ability to lead in the next phase and this is what my remaining remarks will be about. Everybody knows the role in strengthening americas Biomedical Research into supporting Public Health especially during the crisis. Unfortunately it became a lightning rod for partisan debates during the pandemic and that eroded the trust between the nih and the public. First and foremost you will be tasked to rebuild the relationship with congress and the public being a leader that represents the interest of all americans and not just of the scientific community. This means making the agency more transparent and accountable to congress while advancing cutting edge science effectively communicating to the American People and rebuilding trust between Public Health officials and the Biomedical Research community. The director must also protect and strengthen the valuable Publicprivate Partnerships that make up our Biomedical Research enterprise. And sometimes that Publicprivate Partnership is underestimated but clearly the private and the Public Partnership has been what has made the United States a leader in innovative drugs. Last month i issued a request for information on the stakeholders on modernizing the nih and this would include buying small. I look forward to hearing about your vision and how you shall achieve. During the meeting we spoke about the bioethical issues including field tissue and Stem Cell Research and the use of hormones and other transition, gender transition interventions on children, like on children. Frankly at times you avoided getting into specifics citing a lack of expertise. But as the director, you will have to have this expertise. And you will need to be prepared to weigh in on topics that are not in your Research Specialty but across the entire enterprise making policy decisions that will shape the direction of the Biomedical Research. While you consult with experts and take input from your directors you are ultimately the person who decides. I would point out that this hearing is apparently happening today. It wasnt going to otherwise because the publicly acknowledged deal Biden Administration cut to implement partisan drug pricing policies in exchange for advancing your nomination. Biden Administration Officials told us in the hearing earlier this year policy is similar to those in the deal that have been reported could risk future partnerships between the government and the private sector. By the way, future partnerships critical to generating the cure important for cancers and alzheimers into the next pandemic. Partnerships and the foundation of the Biomedical Research enterprise which by the way leads the world in developing these cures. Its concerning that the administration would jeopardize the longterm success of this enterprise for the shortterm goal of advancing your nomination. Last week i asked President Biden into the secretary for a full accounting of any deals cut with members of congress relative to advancing the nomination. At 5 43 last night i received a letter that presided no information and intentionally ignored the request it was supposedly responding to. The administration wasnt forthcoming about any deals with members of Congress Even though some of the details have been reported in the press. Senators expected a vote on the confirmation should be aware of any such deal prior to the nomination. We speak about the breakdown of trust and its rhetoric which is true but not related driving the process by the administration on something that we should know about but we are not being told. We sent the acting director a letter about the funding that resulted in the death of two adolescents. We didnt get the response until september 15th. I have concerns given the administrations history of failing to respond to congressional oversight requests particularly for members of the committee that are responsible for that oversight. So rebuilding the relationship with congress will require a strong director who can overcome partisan divisions, overcome the administration stonewalling of a request from members of the committee for that information pertinent to the work of this committee and work with both republicans and democrats to improve trust in our federal health institutions. That means being open and responsive to this committee which would directly oversee the work as nih director if you were confirmed. I look forward to hearing how you shall fulfill these parts of the job and move the nih forward. Thank you and with that i yield. I would now like to welcome our nominee doctor Monica Bertagnolli has served as the director of the National Cancer Institute Since october, 2022. Prior to that role, she was a surgeon at Brigham Williams hospital and professor of surgery in the field of surgical oncology at Harvard Medical School she served as president and director. I think her for being here today and turn over to senator john barrasso. Thanks so much mr. Chairman and im pleased to welcome to the senate the committee Monica Bertagnolli who was a physician and wyoming native. President biden nominated her to be the director of the National Institutes of health and its certainly not everyday that one of wyomings very own is nominated for such a high position in the nation. Doctor bertagnolli has devoted her entire life to medicine and medical research. She earned a bachelors degree in engineering from princeton university, graduated from the university of Utah Medical School and completed her surgical Residency Training at brigham and Womens Hospital in boston. She then went on to be a Research Fellow at tumor immunology at the Cancer Institute in boston and later served as the chief of surgical oncology for over a decade. Shes continued caring for patients at brigham and Womens Hospital while being a renowned Cancer Researcher and also served as a professor in surgical oncology at Harvard Medical School. She strained not only the next generation of doctors but also Cancer Researchers. This makes her a perfect fit to serve as the current director of the National Cancer institute. While many may know she is a wellrespected physician and researcher that she is, wyoming knows her as part of a multigeneration ranching family and im proud to say that she has never forgotten where she came from. As i traveled and met with folks across wyoming and the Mountain West ive heard of her great work not only as a doctor but also on the ranch so that includes the ranch neighbors. If you want to somebody you talk to their ranching neighbors. They speak of her grid, endurance and determination. Her commitment to the land and livestock speaks volumes about her character and courage. She understands the needs of rural health and frontier medicine. She has used her background medical as well as the values that she learned growing up to improve healthcare for all americans. She served as an advisor to the Cancer Institute in Salt Lake City utah which is a designated Cancer Institute for wyoming. She also advised them on how to reach patients in rural areas and focused on reducing burdens on patients by using local Cancer Treatment clinics. One is in the Sweetwater Regional Cancer Center in her hometown of rock springs wyoming. Her firsthand experience in accessing healthcare in Rural America gives her a perspective that is often lacking in washington. She has annexed intensive track record of cultivating Publicprivate Partnerships to push medical innovation forward. I know this background will serve her well as the director of the National Institutes of health. I have tremendous appreciation and admiration and respect for doctor bertagnolli and with that being said mr. Chairman i do have serious concerns about the way this administration has handled the covid pandemic as politicized agencies such as the nih attacked innovation to the inflation reduction act. I think its important that this position be filled with someone with a critical and open mind ready to tackle the important challenges ahead and for all these reasons, i support the nomination of doctor bertagnolli to serve as the director of the National Institutes of health. Thank you mr. Chairman. Thank you, senator. Do you have to be italian to be from wyoming . [laughter] in a bipartisan way. The stage is yours. Turn the microphone on, please. Chairman sanders, Ranking Member cassidy and members of the committee, thank you for considering my nomination to be the director of the National Institutes of health. Its an honor to appear before you today to share my vision for the nih. I want to thank President Biden for trusting me with this nomination and a senator barrasso for the very kind introduction. I also want to thank my husband and my two children for their unwavering support and unqualified love. I grew up on a ranch in southwestern wyoming. My early inspiration with my uncle he was a primary care physician whose practice included a traveling across the entire state. Its a big state to provide expert care to veterans. And it was his devotion that inspired me to pursue medicine. Like millions of americans, when my father had cancer, the care he needed was hundreds of miles away. So ive seen firsthand what it means to deliver to those living in the Rural Communities. I spent my entire professional life working to improve Cancer Prevention and treatment. Ive done this as a surgical oncologist, researcher, professor of surgery helping to trace the next generation of doctors and scientists. As a physician scientist i run major Clinical Trials, help to advance Innovative Research and most hospitals and institutions to make sure that the most effective treatments are available to all patients and ive had the privilege of serving as the director of the Cancer Institute and working toward the president s cancer moonshot goal to end cancer as we know it. My experience has given me great appreciation for the inner workings of nih and for what more is possible. Recently though i found myself in a different position as a patient when i was diagnosed with Breast Cancer. I was fortunate to have my cancer diagnosed very early. Ive completed my treatment. My prognosis excellent. I also had access to outstanding care knowing full well not every patient has the same chance. Most importantly, every treatment i received was supported by nih funded research. Im grateful beyond words to the patients who joined the Clinical Trials before me, the doctors and researchers that were able to use that information to make the best decisions. Theres so much that excites me about the possibility of leading the Extraordinary Team if confirmed. First, theres never been more potential for progress than what we have today. We just need to harness it. Nih can and must support research that is equitable and accessible to all populations and this includes dramatically increasing Clinical Trials that reflect the full diversity of americans because we know that is what yields the best results. We should capitalize on new innovations in uncovering fundamental biology in Information Technology and exciting new Data Analytics and we must interrogate the broad range of behavioral and social science challenges we face today while laying the foundation to address new issues that will arise in the future. A second, we have an unprecedented opportunity to embrace and increase access to innovation. As a physician researcher for more than 30 years ive seen the transformative power of nih research to produce results that save lives. But ive also seen the patients boost prospects were compromised by preventable factors. We should be able to guarantee that the American People are getting a return on their investment by ensuring they are available and affordable for everyone. Finally, we must restore faith and trust. They continue to be the steward of the nations medical research and a force of innovation and discovery but we must also continue to support education in all fields of Biomedical Research and to inspire young people to become doctors and scientists so that the critically important work will continue for generations. None of this nih can do alone. I look forward to partnering with congress and many others to advance discovery and apply the results of the research to better the lives of every american. Again i want to thank you for the opportunity to appear before you today and i look forward to your questions. Doctor bertagnolli, thank you so much for being with us. Let me begin the questioning by picking up on a point you just made and you put it in your written remarks as well you said and i quote, and it goes without saying everybody here wishes you the very best as you struggle with Breast Cancer. You said and i quote every treatment i have received was supported by nih funded research, correct . Correct. Can you give us some idea based on your expertise about how much treatment for Breast Cancer costs in this country today . If somebody has Breast Cancer or in previous years how much is it going to cost . That is a widely variable result. I truly could not give you an estimate because Breast Cancer is incredibly complicated and can range anything from a simple surgery two years and years of very extensive what i be wrong saying that it would cost hundreds of thousands of dollars . I believe that is correct. What do you say as a physician yourself to somebody whos undergoing treatment for a drug or treatment that was developed by taxpayer dollars that they cant afford or are going to go deeply in debt to pay for . What does one say to a person to say thank you for your taxpayers developing the drug, but im sorry you cant afford the treatment you need to stay alive. How does one respond to that person . Chairman sanders, i have to tell you ive sat in clinics next to patients of my own who for one reason or another could not afford of their treatment. It is a tragedy for all americans. If confirmed i will work with you to the fullest extent of my abilities to ensure that is the case. Thank you. Let me be rather specific. If you are confirmed to be the next nih director, will you commit to reinstating and expanding the reasonable pricing clause in nih contracts in other words . If the federal government puts money into the research and development of a drug, will you insist that the price that that drug is charged in america is not higher than it is in other countries around the world given the fact we pay for the research and development . Chairman sanders, i can say that i myself believe that the American People deserve a fair return on the investment that congress has placed within the National Institutes of health and the research that we do. And i will commit to working to make sure that the benefits of the research are affordable and available to all the American People. I cannot give further specifics at this time about the execution of that plan. So you are not prepared to tell us taxpayers spend billions on the drugs they will not be asked to pay the highest prices in the world for what they pay for . Chairman sanders, i am more prepared than ever to say im going to make sure that affordable and accessible care is available for everyone who needs it. Charging americans with Prostate Cancer are being charged over 165,000 for the exact same drug that can be purchased in japan for just 20,000. 165,000, 20,000 in japan. Is it the drug that is developed by nih funded scientists ucla do you think the price of expanding is reasonable if you are paying eight times more for a drug that taxpayers developed in the people in japan . Chairman sanders, my focus is on making sure that the American People have access and availability and can afford the healthcare that can save lives and that is what i will make a commitment to. Right now, we pay by far the highest prices in the world for Prescription Drugs. The results are higher. Insurance premiums cost millions of people, not able to get the drugs they desperately need. Will you commit to us that you will work to make sure that americans do not pay higher prices for Prescription Drugs in this country than people around the world . Chairman sanders, it would be a great honor to be able to work with you to make sure that the American People have access to the care they need to live long and healthy lives. Okay. My time is up. Senator cassidy. I defer to senator collins. Thank you very much, senator cassidy. Welcome, doctor. The National Cancer institute that you currently lead has the largest budget and Research Program of the 27 institutes and centers at the nih. Cancer research is vitally important, and i strongly support it. Im interested in how you would balance mci priorities while making nih wide budget decisions. For example, President Bidens budget request proposes a substantial increase for the nci, but it flat Funds Research for alzheimers disease and diabetes which collectively affects more than 40 million americans. If confirmed, how will you balance your background in Cancer Research and your leadership at nci with the need to be fair and evaluating agencywide priorities . Thank you for that question, senator collins. I will say that first of all, if confirmed, my commitment as nih director is to the health and vitality of every single american. But i can give you some specifics to address your specific question. How does the cancer surgeon really lead an organization that deals with the huge spectrum of conditions that the American People face. I have two answers to that. First, as a cancer doctor i took care of patients of all ages, all walks of life, all Different Health states. I am very familiar to working with colleagues in cardiology and Mental Health and opioid use disorder, Kidney Disease to take care of my patients with cancer, and i feel very comfortable engaging with the broadest possible team of researchers focused on bringing health to people. But second, one of the things to me that is the most exciting about the opportunity to lead the organization is the fact that so many of the diseases that we are working on individual diseases in our relatively silos really have many common elements. The need access for every community, but even down to the biology. So in my field of research and inflammation and how inflation inflammation causes cancer, guess what, inflammation is one of the major insulating factors behind alzheimers disease, behind autoimmune disease, behind long covid, behind arthritis of so many things focused on a scientific level and on the taking care of human beings level. Im really excited for this opportunity to lead nih. And as you know from our discussion in my office, i would like to see nih funded more projects and more research looking at the role of inflammation in alzheimers disease for example and instead of just funding amyloid plaque, important as that is, research. My time is growing short so let me switch to diabetes. Along with senator murray and a senator shaheen, i had the honor of cohosting again this year the jdr of childrens congress this summer and the director doctor Griffin Rogers said with continued research its possible to imagine that people could lead a life free of the burden of type one diabetes and its complications, which is very exciting. So, we have as you know, a special Diabetes Program that is up for renewal and this committee has overwhelmingly approved its reauthorization. I want to make certain that you understand that that program is intended to supplement and not to supplant the regular appropriation. Part of the program goes for type one diabetes. Part of the program goes for type two diabetes with a special focus on native americans and alaskan americans. So id like to hear your reassurance that you do understand this additional funding. Thank you, senator. I will just say that the researchers and team at the nih are deeply grateful for the resources we get from congress that allow us to serve people and embrace with the greatest enthusiasm particularly communities and efforts that focus on serving people. Senator murray. Thank you very much. Welcome, doctor bertagnolli. Good to see you and thank you for your willingness and a really critical time because as you know nih has a Critical Mission supporting medical research and making groundbreaking discoveries that help everyone stay healthy and keep the nation competitive and give patients hope for the future so really appreciate you being here and your willingness to go through the process and lead this agency. To protect Public Health and prepare for pandemics and a lot more so thank you. Let me start by asking you, i know what the National Cancer institute youve done a lot to address cancer related disparities for women, so in that vein i wanted to ask you today across nih programs and initiatives, do you plan to strengthen research to specifically improve Womens Health inequities including Womens Midlife Health outcomes . Thank you for that question, senator. It is very clear that there are many Health Issues in women that are understudied the really lack knowledge and deserve to have a spotlight shining on them and renewed efforts to be able to provide data to support Womens Health. I can give you a couple of examples that are top of mind for me. We have a Maternal Health i think its fair to say crisis. We had 750 women die either during childbirth or one year after childbirth in 2019, in 2020 when it was 1200. Why . We have to understand that. Thats kind of an immediate need that rises to the top. But there are many other things. The whole lifecycle of Womens Health from childhood all the way through senior adult hood and we know women are different. They react to disease different and we know that we lack the data to know how to best care for them, so you raised in a 80 something i could come at two into say its very important. Thank you. And im working with a number of other women, senator so i will followup with you on that. I think that is critical that we look at it as well. But let me focus on something that you said into that is the Maternal Health crisis. Something i spent a lot of time on. Its a huge issue facing women as you just mentioned especially since the dogs decision and i wanted to ask you what can nih do to improve maternal Health Outcomes specifically . Talk about that for especially black and native american women who face some of the highest mortality, infant mortality rates in the nation. Can you talk a little bit more about that . Thank you so much. I think this raises the issue its a twofold issue. Its an issue of understanding how to care for women during the time of childbirth and immediately afterwards to make sure that their health is optimal but it also raises an issue of disparities and access to care. And in engaging with people and physicians in turn being able to listen to them, to understand them and relate to them. I think the Maternal Health crisis not only is important to biological and medical care, but it raises really important social issues. We need to understand people and their social makeup if we are going to help them best. We will work with following up on that as well. Let me ask you about the fentanyl crisis and the opioid epidemic. Communities as you know are hit hard by that. The nation lost five members of their tribe to fentanyl overdoses in just one week in king county has seen a Record Number of fentanyl overdoses this year so i wanted to ask you if confirmed, how will you work to support research that addresses inequities and access to quality Mental Health care and treatment for Substance Use disorders through nih programs and support those underserved communities that are harmed by the national Mental Health crisis and the rising rate of opioid Overdose Deaths . Thank you very much for your championing this issue. I am myself have lost patience to the opioid crisis. So ive seen what it does. Absolutely devastating tragedy for our communities and it has increased so much over the last years and disproportionately affects certain communities although really its spread across the entire spectrum of our nation. I can commit to working with you and on continuing the great awareness that it has for understanding this issue deeply in ways that Bring Solutions to the people who needed. Like many things, it has to do with not only medical care and understanding better treatment, it deeply has to do with getting the treatment to the people who need it. Thank you very much, mr. Chairman. Senator cassidy. And i deeper to senator teller bill. Thank you, senator. Thanks for being here. Congratulations on your nomination. Before i start, id like to Say Something about your nomination. Its nothing against you. Id like to take the opportunity to draw a comparison between this nomination and other nominations pending in the senate. Ones that im holding from passing by unanimous consent, your predecessor was proved by unanimous consent in 2009 only four weeks after being nominated. The committee did not even hold a regular hearing like this. You faced a much different confirmation process. Your nomination was held up by chairman sanders which is his prerogative. Weve had no confirmed nih director for 21 months. Back in june, chairman sanders came out to oppose the nomination until they received the administrations complaints of plan on lowering drug prices, which we all know thats what hes about and a lot of us are about. He promised to hold of not only your nomination but all healthrelated nominations going through the committee and as a senator, he has the right to do that. He wanted a policy concession from the Biden Administration, and apparently he got one. I was one of the many who want us to have a confirmed nih director. A lot of people have wanted us to have a confirmed director. Its not unusual but i dont remember any democrats saying the sky was falling because we didnt have a confirmed director because this is a very important position. I dont remember the democrats calling the chairman names or even threatening. I dont remember anybody wanting to change the rules in the senate because of it. I didnt really say a word about it. If it were not for hypocrisy around this place, i dont think we could have anything to do. The chairman sanders got what he wanted. Chairman sanders announced that the white house met his demand is and he announced this hearing. Chairman sanders used his prerogative as a senator. I dont have all the details of the concessions. The Biden Administration, but i respect his rights as a senator. I appreciate that the defense of the legislative branch. We ought to legislate around here. Thats what we were sent here to do. We were not elected to just outsource our jobs to joe biden or any other president , and i dont agree on everything, but at least he is standing up for what he believes in and out of the power of the senate. I will get off my horse now and ask you a question. This very, being an educator, this really touches me. The nih funded a recent study about the psychosocial functioning transgender youth after two years of hormones. According to the letter, nih said to Ranking Member cassidy and me, the research seeks to understand the physical and psychosocial effects of medical intervention to evaluate the effectiveness of existing medical treatments already in use among the transgender youth. As you know, too many young people have committed suicide who are part of this study. That is obviously a tragedy. But what concerns me even more is the fact that the nih was funding this research and beyond that i believe they even called the study a success. Thats sick. It sounds to me like they totally dropped the ball on Quality Control and oversight. So if confirmed, how will you make sure nothing like that ever happens on your watch lacks. First, senator, thank you for your affirmation of the critical importance of nih and what we are here to serve the American People and just how critical that is and how important this job is. And to that end in response to your question, we have the greatest responsibility to ensure two things. First, that we serve all people, all people, all walks of life and that we really are here to achieve the health of all about that number to any research we do that involves human beings is conducted according to the highest Ethical Principles so that we make sure that the research is intended to do no harm, to achieve benefits and is done in ways that have maximum respect the dignity of people. If confirmed as the nih director, i will affirm to you that that will be my load of action and highest priority for all human research. Thank you. One more quick question. The nih used to be universally respected, nonpolitical organization for covid, but that trust has been broken especially in rural parts like my state of alabama. You are from rural wyoming, so you get the perspective and understand just how much people in those parts of the country in particular have lost confidence in our Public Health institutions as they feel totally overlooked. What would you do has nih director to help gain back some of that respect in the rural areas . Thank you for that question and i will be very brief. Of two things. Number one, i believe deeply in the doctorpatient relationship. That is incredible value. It patient comes and puts their life in the hands of their doctors and anything that we can do to strengthen the doctorpatient relationship is something that we should pursue to the fullest extent possible and then second, i believe in education at all levels and relating our patients joining us in research to the post extent possible not to science here and people here, but people joining us to do science. I think that is also engenders great trust in the process if its done in a respectful and appropriate way. Senator. Thank you, chair sanders and congratulations, doctor bertagnolli. Im happy to support your nomination. Every time a representative comes before us i ask for an update on the recover initiative congress provided nih with 1. 5 billion in funding to advance understanding, prevention and treatment of the longterm effects of covid including long covid and this is a topic important to me because i live with a mild form of long covid because ive been public about that. I hear from people every day in this body i have colleagues, a former senator or colleague, senator inhofe have talked about long covid experiences. My wife went to a lawyer last week with a friend of ours to help her file for bankruptcy because her treatments for long covid knocked out her balance and leave her in a situation where if she doesnt file for bankruptcy she could lose her home. That are often the ability to get frustrates and saddens me too hear how many long covid folks who are dealing with it do not have a negative impact on the lack of skepticism and disbelief as they described hersymptoms to employers and others. Im also frustrated by the hurt long covid sufferers indicate nih is not doing enough on the issue in their voices are not being heard. Let me tell you what Patient Advocates tell me. Nih is not concerned the input of those living with long covid design enrollment of Clinical Trials that nih is not as responsive as it should be to advocate outreach. That with recover being spread across multiple in situ answers lack of clear leadership in the initiative lacks a point person that told responsible for decisionmaking. Theres a lack of transparency in the budget and future plans for the initiative. Doctor, i know you are working the Cancer Institute is copied directly into the space. And so your knowledge of the inter workings of the Recovery Initiative are limited at this time. But should she be confirmed as director ask you continue to work with me to address the concerns of those living with long covid including you commit to meeting with Patient Advocates to discuss these issues. Et cetera cain thank you very much for that question. I can absolutely confirm i will work with you on this issue. I think this is one of the greatest tragedies we have recently seen. And i will tell you one thing that is something i live by in my research. I love the expression nothing about us without us. This comes people with the lived experience community recalled in the Patient Advocates. I love that expression because it really is the weight we need to do our science. Not only are we serving them because we are listening to them for all the other issues of trust and accountability and respect for the people we serve happened when you do that. You have hit something that goes to my core i be delighted to work with you precooked thank you very much. Next topic i went to ask you is a pediatric Cancer Research. Along with senator moran and 13 other bipartisan members of this body of this committee and the full body we introduced a bill called the Gabriela Millers to reauthorize a program that is same at combating Childhood Cancers. The legislation as a result the ofcontinuing efforts by the milr family to fight Childhood Cancer the revolution 10 years ago nih Research Budget only a very, very tiny percent, less than 1 , was devoted to Pediatric Research in cancer space im pleased to say the bill was voted out of Committee Last month with a very strong bipartisan support. You are familiar with the challenges combating Childhood Cancer in particular. As congress looks to reauthorize Critical Program could you tell me how nih will continue to expand its efforts using data speeding up research particular for childhood diseases such as pediatric cancers. Yes thank you. This is a major focus of my work since coming to nci and will actually be carried over nih. Since time is brief the beautiful beautiful Gabriela Miller when she looked into that camera im sure you have seen it for and paraphrasing adult member exactly but she looked in that camera and said quit talking, get working or Something Like that. It just gets to your heart we take that very seriously. Thats what inspires us to go forward. Thank you very much for your back. I defer to senator marshall. Thank you center mr. Chairman went to submit for the record first and up it in the Washington Post april 11, 2002 by Democrat Center for the great state of indiana and of course one of my boys heroes liquor et cetera bob dole from the state of kansas. It is an oped about the bite duel act. Im sure doctor you are familiar with this. This encourages, entices the private practice to seek publicprivate Research Collaboration rather than focusing on proprietary research. If confirmed will you commit today to uphold the integrity and intent of the bite dual . Thank you, senator. If confirmed i will commit to uphold the integrity of the act precooked thank you. Next soon to talk about research in 2022 nearly half of all funding went to institutes in just five states they happen to all be on the coast i think only center of the research and one or two geographical locations you have incest. You have decreased randomness of thought university of kansas Cancer Center second to none nci designated Cancer Centers in 2012. Kansas State University received nih funding in 2021 to support it becoming a National Leader in emerging infection. Childrens Mercy Research institute in kansas city advancing the genomic medicine develop mental behavior im theatric brain Cancer Research, will you commit to correcting these issues so Innovative Research of the midwest or equally prioritize . Thank you, senator. Not only will i commit, i can give you an example i wear my past work is try to achieve its already Cancer Clinical Trial group one of my main goals was to make sure those trials reached as many communities as we possibly could. We partnered with a wonderful physician practice in laredo, texas serving the border community. A wonderful position who served at pine ridge indian reservation one phone call just in my home town of rock springs, wyoming i agree few completely nih research has to reach everywhere there are many, many centers of great excellence that we should have the ability to engage for. My next questions a lot tougher one. Doctor you and i both protect very honored profession. When i think about the horrors of medicine the great horrors of medicine, the things we got wrong you think of bloodletting. I am afraid that 100 or 200 years from now those same historians are going to go back and compare irreversible mutilation of adolescents for transgender surgery, irreversible and giving them irreversible medications is going to buy those two wars are going to be talking about for the going talk about bloodletting and the fortification of disfiguring surgery for people 80 of them in a couple years once they have hormones of their own are going to sate maybe that wasnt a good idea. Before you answer this question i want to to think about the oath that you and i took it his way over quota but its above all do no harm. Above all to no harm. So heres my question. Should Taxpayers Fund gender reassignment experiments or research that are purely cosmetic destroy healthy tissue and organs when these fda approved products off label for significant negative irreversible impact . Again its not treating diseases or illnesses. Should taxpayer funds be used to do research or fund these irreversible horrifying irreversible procedures and that use of the hormones off label . A senator, thank you very much. It is very clear that you share my concern over the wellbeing of the Lgbtq Community especially young vulnerable people. What i can tell you that is if confirmed i will commit to leading nih to conduct the research that will achieve the very best health for these vulnerable special individuals precooked sorry to cut you off right there do you believe that it is okay to fund this type of research with these irreversible procedures are being done . Do you think there is any experiment you can think would justify irreversibly damaging these poor little boys and girls who are 14, 15 years old will you fund up type of research . Any research that we do senator with regard to human subjects has to be done in a way that does no harm and produces the maximum benefit to the people who are participating in the research. That will be the principal with which i approach in the research especially for this vulnerable population. Thank you yelled back. Quick senator smith . Thank you chair sanders and Ranking Member cassidy. Thank you so much doctor for being here. Its wonderful to see you again i am just delighted to have the opportunity to support your nomination on this committee and also as we move you forward to confirmation. I would like to actually follow up on something senator brosseau started with and focused on which is your personal experience in wyoming. Experienced in Rural America not going to ask about the ranch although i would be tm tempted to. It meshes with a very clear policy interest of mine which is radical rural health and a focus on rural health. We dont Healthcare Settings across the country there is a real shortage of healthcare workers this effect is relief reallyfelt particularly intensen Rural Communities that are struggling to maintain hospitals and maintain access to care. We have had important innovations over the last several years i would point specifically to telehealth as a way of delivering care. Could you please talk with us a bit as you think about your own personal expense at rural committees how can nih ensure access to the most advanced medical research and other treatments regardless of especially if you live in small towns and row places in this country . Thank you so much for that question. Our job is not done if we just produce effective treatment or an effective approach the job is not nearly done. Our job is only judgment people are living long and healthy lives. And so that means a critical area nih Research Needs to be Healthcare Delivery research. I will give you a quick personal note. The town where my parents lived and central wyoming, no hospital within 100 miles state, commuted, federal and tribal participation this new hospital being built there. I am committed to seeing that new center and that new location be brought into the Research Enterprise that we can understand how these kinds of federal, state, Tribal Community partnerships can be brought to bear to be able to deliver better care just as one example for. I appreciate what you are highlighting which is the importance of partnerships and the real importance of nih attention to training and Research Opportunities in Rural Communities. Theres a lot of good data to show off your trade at eight rural pleasure much more likely to stay in the rural place. Its good best practices for how to do that. I have to say i share chair sanders concerns about our challenges delivering care in this country. And so theres lots for us to work on there. Another area want to touch on before i wrap up is the importance of focusing on research around Mental Health care. This is something in important issue to me less than 5 of the nih Health Budget goes to the National Institute of Mental Health but less than 5 of the overall budget but one invite about 20 are going to extremes and Mental Health issue i wrote here. We dont Mental Health and physical health not to separately Different Things theres a brain help with the rest your body health. Could you talk a bit about how you view nih role in focusing on that connection between mental and physical health, brain health of the rest of your body health . Advanced research on Mental Health . Mental health affects every disease retreat how someone can manage their cancer journey. It affects kidney failure is getting needed care affects our physical thing we do. One of the things im really excited about is confirmed taking on the role. It is to really focus on all these interactions between the various institutes common themes need to be addressed in order to treat the individuals. Mental health is overarching and needs to get into everett research institute. That is number one. Leverage the funding that goes into the Mental Health institutes being able to pull on that for the resources of the entire nih. Thank you for your advocacy and raising this really important issue. Raising awareness. Thank you very much mr. Chair. I think he Ranking Member. Chairman thank you for being here congratulations on your nomination the great state you come from. Research tells us children in the womb respond to and can feel pain at 12 weeks. Needle anesthesia is recommended for surgeries at 13 weeks. Their doctor, before obtaining consent for a fetal tissue donation will you commit to requiring nih contractors and grantees explicitly inform others search out the feel pain during an abortion by 12 weeks of pregnancy . Thank you for raising this issue. I believe the policy and pam procedures that govern any research with fetal tissue prohibit any discussion whatsoever with the mother toward even the possible use of such tissue for research. It would not be acceptable for me too affirm this that interaction is not allowed to take place. Thank you, chairman of yelled back. Think it mr. Chairman and thank you to you and reiki member cassidy for this hearing. Doctor company so good to see them congratulations on your nomination for thank you for your willingness to serve. I want to follow up on a line you heard from senator murray and just often Sanders Smith the National Drug abuse nih plays a vital role in responding and Substance Abuse and addiction. This has contributes substantially to our understanding of medication is such a treatment for opioid use disorder and validate the effectiveness and safety of evidencebased medication to treat addiction. As a result of nih leadership it is now widely accepted as a Gold Standard of care for individuals struggling with opioid use. Last year i work with center at makowski to pass into law the mainstreaming Addiction Treatment act which eliminated unnecessary hurdle for providers describing and further expanding access to his lifesaving treatment but however despite this push to increase Access Research shows a high level of stigma lack of provider education still stand in the way of individuals saving assistance. Dr. Kagan can you tell so you will develop strategies to limit the stigma around medication assisted treatment . Thank you for that question. Yes i think the overall issue of Substance Abuse first about is a tragedy second of all that tragedy is compounded when on top of it there is stigma associated with the disease. That stigma needs to be combated at every step. I fall back to what is the first and most important relationship . Thats a treating physician and the patient together. Trust between those two is trust and support we can do more to raise Community Awareness this is another area of the best way most respectfully to Garner Community support for individuals battling Substance Abuse. This is an important area of research we know how to do it respectfully unwell. Think it will you commit to continue to grow the National Institute of drug abuse work on treatment for Substance Abuse disorders . I will commit to working with you to fully pursue work at nih to end the scourge of Substance Abuse. Thank you. I want to move to a different topic. Antibiotic resistance is a serious emerging threat to global Public Health. In july at you and i discussed nih Important Role in Antimicrobial Resistance research and development. We need to Work Together to encourage the development of new medications that are able to treat infections that are unresponsive to current antibiotics. Dr. Kagan how do you envision nih role in the Public Private partnership to combat Antimicrobial Resistance . Certainly this is a critical issue for Drug Development which has been successful at to a certain degree being able to head off the continual problem of Antimicrobial Resistance. I support any research that can help us get jet aim for people i will also add virtually everything we do in medicine there is also social and educational component to this. It is not just finding a new drug to beat the bug it is making sure prescribing practices for antibiotics for use in agriculture, all of these other efforts that can be and it can make the problem worse and perpetuate the problem also need to be an area of our research to be able to combat pickwick say thank you for that. Other other new strategies you could be looking out to improve Clinical Trials for new antimicrobial medications . I understand the last point you made we need to make sure we are considering the research so we have new classes of these medications by. Yes thank you. This is a very important issue for Clinical Trials i will also just take it at aside to say we have so much work to do in the Clinical Trials arena. One of the other commitments i want to make for Clinical Trials since that has been on my core expertise that are faster, more inclusive, and more responsive to the needs of people it is one of the major initiatives i would like to see happen at nih projects i appreciate that. I just also want to look forward to working with you im interested in bipartisan approaches to support innovative antimicrobial research. Including leveraging the tax code and i really look forward to working with you and the rest of the department to achieve this goal. Thank you mr. Chair. I defer to senator murkowski. Thank you. To the chairman to the Ranking Member. Dr. Kagan thank you for being here and taking our questions. I appreciate the response youve just provided about Clinical Trials. I am very invested and focused on what is happening within Clinical Trials for als. Ive got a personal connection i think so many of us to have a personal connection and we recognize the horrific progression of that. I will submit to you a pretty specific question about how we can make als Clinical Trials more efficient looking perhaps alternative sources to better or more precisely measure als progression. But it is what you just said about leaning into this and placing a priority on it is something i appreciate and i look forward to further conversations with you on that. You have already responded to questions that i had, senator smith asked about rural health thats of to something coming from alaska we would certainly encourage Greater Research in rural areas that do not have carrot delivery sites. One of the other issues i wanted to bring up was what senator murray raised with the menopause researcher. I was able to meet with some advocates just a few weeks ago. It is shocking to me too know one of the lifestages in women whether you like it or not is a menopause and how little we actually know about the impacts and many of the treatments for Adverse Health conditions that are associated with menopause in particular. Let me ask my question about Infectious Diseases. A week, and alaska are plagued and have been for a long period of time but it continues throughout our state. We see preventable chronic Infectious Diseases particularly tuberculosis and hepatitis c. As of 2021 alaska had the highest incidence of tb in the country. Again we have very rural areas. Hep c the rates there have been increasing statewide now for two decades despite the availability of the curative treatments. I have been in small rural airports and run into Public Health workers that are there solely and specifically monitor what we are seeing with hepatitis c. So i would ask, how the nih would approach coordinating with other federal agencies whether its the state, local, tribal governments to do more with eradicating these chronic Infectious Diseases not only tuberculosis and hep c, but the sexually transmitted infections as well. Because again this is an area we see rates that are in my view beyond intolerable whether there are possibilities for cheap pointofcare testing for sti. Talk to me a little bit about what progress we could make or what we could hope for progress thank you, senator. Im not Infectious Disease specialist i was not previously aware of these unique features of the citizens of alaska. It is rougher. I can comment briefly and say certainly for hepatitis c and tuberculosis and perhaps even sexually transmitted diseases the two keys to managing its prevalence in a population are diagnosis, detection hepatitis c can be silent for decades people do not realize they have it so they do not get the proper treatments. The same with a tuberculosis. Many Workplace Institute routine screening if you go to the hospital you get screened every single year through that screening to identify individuals that need treatment are really in important part of control. Instituting the best approach is for that. Again i have to defer to colleagues who are experts in infection control. I will be very pleased if confirmed to work with you to address these specific issues for the people of alaska. We do have some great experts that are on the ground who are very familiar with this but it is the coordination im hoping we will able be able to see between federal, tribal, local thank you very much and thank you, mr. Chairman. Mr. Chairman, thanks it very much. Doctor bertagnollis thank you for putting yourself forward for this position. Especially at this time with so many challenges that we face as a nation. For more than a decade i have led the annual bipartisan appropriations letter advocating for funding for the National Institutes of health. Most recently working with senator tillis a letter we were joined by 56 other United States senators. At the end of that letter this year we say and this is quoting one part of the letter quote if we are to continue grappling with emerging threats as well as improve the health of americans and the quality of their lives we must continue to invest in Biomedical Research that has the potential to save money, improve lives and operate economic return for a nation. We are proud to be able to do that will continue to advocate for robust funding for the National Institutes of health by do not have to remind anybody the reach and scope of the National Institutes of health they literally touch lives of every american. We are at a time is both enormous potential for advancements in Health Science but also great, great challenges such as the risk of disinformation the decreased trust and medical experts. The National Institutes of health in my home state of pennsylvania provides tremendous value despite those challenges that i mentioned. Pennsylvania reachers compete for grants each year totaling almost two and half billion dollars. The funding directly supports more than 28900 jobs in pennsylvania plant also contributes to a thriving Life Sciences sector in the states. We have a lot of steak as a commonwealth but also for country. I want to commend the work you have done at the National Cancer institute related to pediatric cancers. Diseases which are almost universally fatal decades ago are now largely survivable thanks to investments in research. If confirmed how we work to ensure nih continuing to invest in Childrens Health and children are being appropriately represented clinical studies . Works thank you very much for that question. There has long been, you recognize that children have been definitely understudied and certainly the conditions that affect them have not received as much attention from the pharmaceutical industry has some adult diseases. What can we do it nih . A couple of things. First about recognizing the importance of developing collaborative mechanisms that bring pediatric cases together for study and knowledge. Many pediatric cancers are Rare Diseases heard one of the great successes that we have had spent to bring together a community of patients, researchers, caregivers around bringing together data from those taking care pediatric Cancer Patients across the nation. It does not obviously stop at nci. Every single Disease Center needs to focus on the youngest americans. Making sure we address their needs with Clinical Trials that are targeting the deceased they suffer from brick last thing i will say prevention, prevention is key all of us need to prevent prevention has to start when we were children. Not only targeting diseases that kids have but targeting new strategies to make sure they get the preventative therapies that can last them a lifetime. One of the strongest ways we can influence their health overall. Think your instructor. I wanted to finally ask you about work that i have done with regard to rear disease patient groups over the years. One challenge comes up repeatedly to difficulty in demonstrating a potential therapy is effective due to poor natural histories of these rare and old short Rare Diseases. Can you talk about the role nih can play when working with the fda to support research into Rare Diseases that can help advance our understanding and support the development of safe effective therapies . Yes thank you, senator i can give you very specific example of this one. Nih Clinical Center is an absolute treasure. There is a program nih center today that i can speak to most easily it has to pediatric cancers that takes very rare pediatric tumors, assembles a team all the way from basic biology to Clinical Trials, importantly Publicprivate Partnerships and partners to bring together a community to be able to treat that disease. Those individuals all come to the Clinical Center throughout the nation. It is incredibly moving when you see people who have a rare disease or children with a rare disease and her family is there for the first time meeting another person who has that relate rare disease its incredibly moving experience that community built around that centered around our Clinical Center is making tremendous progress one by one part i like to see that model scale dramatically. Thank you dr. Kagan thank you mr. Chair. Quick Center Cassidy i have lots of questions so if i interrupt you please be tight with your answers if i interrupt you i apologize in advance. Usage and your staff and tribute you support the reasonable price pricing clause included in the recent contract with a barta but you were not familiar with the nih experience the 90s. Clinton administration nih director stated resending the policy extensive review indicates the pricing clause has driven industry away from potentially beneficial scientific collaborations. And eliminated the clause promotes research that enhances the health of the American People. Research america and the lives of hundreds of organizations advocating for Biomedical Research expressing concerns about the policies that would quote discourage the uptick of breakthrough the uptake of breakthrough discoveries by the private sector. This would be detrimental to patients. Would you apply at reasonable it reasonablepricing clauses tos if confirmed . Ranking member cassidy my absolute utmost priority will be securing effective treatment. My question would you apply it reasonable contract pricing clauses nih contracts . I cannot commit to any specific action at this time pickwick sebastien to commit to not an action pair. I will work with you on this issue. I share your desire to make sure people have access. My concern is based upon doctors experience if you do institute you are going to stop the translation of research of taking care of patients. This is not publicly to post a photo brown. History tells a fee if you do it patients or damage despite are e whatever rhetoric might be out there. I hope you would be more forthright in embracing this issue. We have Scientific Evidence my gosh we are doctors we should look at the evidence not listen to the rhetoric. I say that because i know patients are going to be damaged by this that should be our highest calling. Do not mean to brag i just get frustrated. Okay what about rights you mentioned want to lower cost your predecessor Francis Collins consistently said during his tenure the nih does not have authority to use merchant rights to lower drug prices. It goes against congressional intent if you only use it to lower drug prices. Do you support using merchant rights to lower drug prices quoted quote . Again at Ranking Member i cannot commit to any particular policy right now. That is though statistically says youre not supposed you gives you three ways to use it. What if it does not include lowering drug prices. We are just asked are you going to follow the law, that with the action for. I will follow all the laws of our atlanta. People get the treatment that they need pickwick sounds good, with that answer sounds like youre answering my previous question that you would not do the other thing. Let me ask you about another issue. Secretary chose not to continue nih ethics Advisory Board reviewing extra mural fetal tissue issue for propria string approves administration. And presumably a panel like this would help achieve what you tell me the preferences of ensuring fetal tissue is only used as a last resort. I am told there are members of this board who supported Fetal Tissue Research. But still rejected some of the Research Projects put four by nih for the boards review because of a lack of informed consent. You stress in an earlier answer. These approach fetal tissue advocates rejected these proposals because of the lack of conform consent. But secretary has continued this board providing that safeguard. Do you agree with the with the secretarys decision to not continue this . Senator i do not have enough information about the specific actions to comment on secretarys decision. What i can affirm for you is any Research Needs to be conducted according to the most stringent ethical progress as head of the board is making sure those the case of rejected some of those as a mechanism by which you were telling me was executed. The informed consent was not that if we stipulate as a theoretical when i laid out the facts are correct we shoot support reconsidering the board . Again i cannot comment on the specifics of that activity. I can just say that if confirmed i will uphold the principles of ethical human research. Is spent four years almost in since coverity pandemic began we do not know for the verse written originated. Of possible alternatives experts agree for that research is needed cube with the federal government should do everything it can to determine the cause of covid19, including the possibility emerge from a lab that was conducting gain of function research . Ranking member cassidy i think no one wants to know what the true origin of the last coed pandemic wasnt more than the biopic works help you accomplish that . To the fullest extent of our ability to gather the data and have access to the data. I make a valid assumption. Make a day that we have available. Welcome to the Health Committee and congratulations on your nomination. Ember on the Health Committee are also in the Appropriations Committee i want to address the budget for the fiscal year 24. Despite the challenges we face in writing labor hhs appropriation bill because it included the availability of less money overall than we had an fiscal year 23 hour bipartisan fiscal year 24 bill builds on our longstanding commitment to nih. And Biomedical Research in general. We secured critical increases in our bill for agencys most important programs. 100 million increase for Mental Health research. 100 million increase for alzheimers disease research. 60 million increase of her Cancer Research. 12 million for new Palliative Care Research Program. So as a Cancer Researcher i wonder if you could describe how the recent invents mens and nih specifically in Cancer Research have advanced care for patients and improved outcomes . I also want to challenge you to talk about the impact the house passed im certain up the house the past the house bill that is pending that has drastic cuts in Biomedical Research, how you would tackle that if that became law . Thank you, senator. First let me say i speak for everyone nih to say we are deeply grateful for what we have received in the federal government in order to conduct our research. Number two we still may speak as a physician over my 30 plus years of being a physician i have seen the tremendous advances that have been made as a result of nih funding. To take on the clock and that many advances that have happened just met last year just let me assure you people are living better, longer as a result of nih research. I think you are also asking to address how changes in funding every penny we get the fulls extent possible we will focus on the issues that congress brings to us as important should. And i really embrace working with you on those key issues. And then finally if our budget test method is a chance our budget will force us to leave opportunities on the table because the opportunities are enormous. And i will just leave it there. There have been two biosafety incidents involving the h5n1 virus at the university of wisconsin madison. In both cases there is a lack of guidance and oversight from nih. Which i find very, very concerning. As chair of the appropriations subcommittee i worked to secure language and funding focused onn this issue an hour bipartisan fiscal year 24 bill. In addition to directing nih to articulate the roles and responsibilities of investigators and institutions conducting this reach roots the fiscal year 24 bill witt established for the first time at the office at nih to serve as a resource and to brett provide tools and guidance for the research community. Doctor bertagnolli what steps would you take to enhance the oversight of nih Funding Research involving a potential pandemic pathogens . Thank you very much for your advocacy for this very, very important issue. You know potential Pandemic Pathogen Research achieves great benefit by allowing us to respond immediately and save lives. But it also has risk. I can commit to you if confirmed as nih director i will fulfill the highest possible oversight for programs that engage in this kind of research. Review and oversight to make sure they are conducted safely and achieve the benefit we note we can see for the American People. Correct thank you mr. Chair. Quick living in a National State of emergency more than one and two transgendered non binary youth have seriously considered attempting suicide. What elected officials use the bully pulpit for gender affirming care, treat evidencebased lifesaving treatment fuel the fire of the youth Mental Health crisis. This is a driving force in a nationwide campaign of discrimination and it is unacceptable lgbt cute youth young people let me just say this very clearly trans rights are human rights. And i am never going to stop fighting for essential Research Investments into care which you need to make sure everyone is free to exist as their authentic selves we will not rest until youre free to live openly, authentically and safely. Dr. Kagan thank you for being here today. Ive heard from many people in massachusetts and many oncologists by your excellent work and leadership it is clear you have a commitment to Public Investment to try research that will improve Americans Health must treat illness and cure disease. Last Year Congress passed my bipartisan children immediate Research Advancement act requiring National Institutes of health to conduct research and technology it medias effects on infants, children and adolescents and provide nih with 15 million to launch this program. We already know big tech exploitation of younger users is driving a Mental Health crisis this research will further document the serious harms caused by the Online Platform and social appetite for childrens and teens personal information. Dr. Kagan if confirmed will you commit to prioritizing that research . We have it Mental Health epidemic amongst teens and adolescents in american reports thank you center marquis. As the parent very recently teenagers i can certainly comment to a great concern about the amount of time spent in front of computers and the worry of a parent as to what that is really doing. I can commit to this a very important issue for nih research. Understanding with the new Technology Means for our young people. Really everyone but certainly more of a focus on the young. I also know this is an issue that is of great concern for Surgeon General and look forward to working with others across hhs on this issue because a Surgeon General has identified identify theproblem, center casi have coming out of the Commerce Committee successfully an upgrade of the protections for kids online up to age 17. We are hoping to move that on the senate floor. But we also need the documentation from nih as to the underlying which is being created as we sit here right now. Since the passage of the National Alzheimers Plan acton alzheimers accountability and investment act that senator collins and senator warner and i havent worked on nih research is contributed to significant advancements to understand and treat alzheimers. Yet we have a ways to go were we arejust beginning to underste impact of air pollution and Environmental Justice on the brain. Black, brown, disabled and Rural Americans face discrimination and other barriers to access to treatment could expensive treatments for longer travel times to care family fare get caregivers struggle every day with providing care to their loved ones with alzheimers. Doctor can you just tell us how you view the nih role in continuing to lead Alzheimers Research and new Direction Center equity and access and support the family caregivers who are so often at the front lines of providing care . Thank you so much for that question. It raises many issues i will just go back to maybe my core approach to things such as this. First, understand the biology is what produces this condition that means going all the way back it may be even to the fairly early years of life so we can think about prevention rather than treatment. That is really critical and encompassing a broad population of people to inform that. Next, dealing with what we have today. People who are really suffering. Families for which this is a tremendous burden having difficulties developing new treatments that can work now for people suffering from the disease. And as you have already said it is part of nih to think about care delivery that means delivering for the caregivers. Taking care of the caregivers because they are really an important part of what helps us achieve Health Records again our goal is continue to increase funding for nih research, medicine, field of dreams which we harvest the fighting so give hope to families that we can secure for alzheimers nih is the National Institutes of hope for all the alzheimers families thank you. Thank you, mr. Chairman. Else Oversight Committee subpoenaed acting nih director for documents relating to the investigation doctor carranza top advisor to dr. Fauci accused of using a personal email to avoid public accountability according to him delete anything he did not want to see in the New York Times regarding the origins of covid great subcommittee release emails allegedly and requested information in june and again in september. If confirmed will you comply with any subpoenas the house sends to you relating to the origins of covid19 . Thank yous editor i can reassure you i take congresses responsibility for oversight for the nih and if confirmed my responsibility as director of the nih to be compliant with the policies regarding that oversight extremely seriously. I can confirm that if i assume the position to be accountable and transparent to work with you to resolve his important issues for correction of you ever spoken to doctor morans about covid19 pandemic . Note senator i do not know him. Okay will you commit to not use a personal email for official nih business . Or try to shield conversations from the American Public . Yes center absolutely. Oxo dust like the comment about one more question for you. Senator hawley and i actually passed legislation asking the white house to release all the material they hold and classification on the origins of covid19. There is a local out there they have not complied with that. Without. We are still trying to get them to comply with that remember youre working for that administration. This one is a question in terms of any relationship youve got with big pharma. I think you have received millions of dollars from big pharma to support your research. You sat on the board of several companies receiving Stock Options and bonuses. Our country relies on its Public Officials of their best interest in mind when performing their duties as public servants. How can the American People be sure nih director you would be focused on the job at hand rather than boosting the business of any past associates in the pharmaceutical industry . Thank you for that question. I just want to confirm for the record the funding i received from pharmaceutical companies is to conduct research. Her own personal cell at my only salary i received during was the hospital salary set based on academic rank i have one instance of receiving a payment directly from a Pharmaceutical Company for the board of directors for a single Pharmaceutical Company. Finally the more important question i completely agree with the need to have a one goal. One constituency i am serving that is the health of the American People by. Thank you, one quick final question here. I think you signed an agreement with senator warren about what you might do after this poster. From the information i have got you wont seek employment for compensation from any Pharmaceutical Company. Is that correct . This that mean that if you do it you will turned on those offers . The American People and congress i will act with the goal of the very best interest of the American People if confirmed for this job. I have agreed for a time of four years after stepping down in government i will not accept employment at a major Pharmaceutical Company. Pickwick thank you very much. And thank you missa bertagnolli. Appreciate your service and being willing to step in at the ski time. Emerging technologies, ai is top of mind. Theyre becoming ingrained into various parts of our lives. Healthcare is obsolete no exception. Ai is primed to assist with the trial design. Realtime monitoring, predictive analysis go down all the on allt aspects of Clinical Trials which are so expensive we have all agreed over a long period of time the cost is a barrier to progress. So doctor bertagnolli do you think the event of ai will create efficiencies in our Clinical Trial systems and other particular pitfalls we should be mindful of when considering technology in trials . Thank you very much for the question. Machine learning approaches, Artificial Intelligence are really wonderful new methods we are all very, very excited about. We have long had the scale of data. Allows to analyze it properly. However the more we learn, the more we use the techniques the more we realize they have to be, like any tool used in a careful responsible manner particularly when it comes to human research. The short answer is yes absolutely per this is very exciting. But with a qualifier the design and conduct and data used to train these models need to be very, very carefully considered to make sure were getting the results that matter and are meaningful for all people. Any specific pitfalls you want to put on the record . You know the most serious woman care about a lot this ai method that might be designed and trained on one particular ethnic group or one particular category of people who have a perhaps more access to treatment than another. I get a result that continues to disadvantage others who need to be included in that kind of research. That is one really serious one but there are many. It is a computational method after all it has to be doing what we wanted to do. The algorithms are not as transparent as some of us might like. Too. Exactly, exactly thank you. Heart and bring him and williams hospital credit multiregional Clinical Trial center. Obviously you are very familiar with giving thats our time at both institutions. Prime focus improving the safety and efficacy of global Clinical Trials. They trained representatives trs literally from dozens of countries but exclude good clinical process and practice. This leadership i think its critically important. Often underestimate the significance of it. We live in an interconnected a wonderfully diverse world. That interconnectedness and diversity does have its own challenges as well we should beat making sure we utilize all available data to inform our resource decisions. What more do you think nih could be doing to encourage the use of safe and rigorous global Clinical Trials . Thank you for that question i have personally conducted global Clinical Trials in the area of cancer. That was done through the use of very careful protocols that deliver data in very careful formats sent also monitored sites so we knew exactly what care is being delivered as part of the trout that was testing a treatment. For things that really matter that level of quality is very, very important. I will add parenthetically that there are other things we can do in Public Health globally that do not necessarily need to sit in that very tight model we should look at everything we can to help inform our work. Could not have said that any better myself. Doctor bertagnolli eagerness and optimism as a result of her western roots which i have great appreciation for private other questions i will submit them on the record and thank you once again the way to serving you for your commitment to Public Service and turned back to the chair for. Thank you. Think it mr. Chairman and she Ranking Member for this important hearing in this conversation. Doctor bertagnolli its an honor to be with you today. And i want to begin by recognizing and thanking you for your help and providing archived data from the National Cancer institute regarding radiation exposure from atmospheric testing and western states especially as we have an opportunity to provide more support for these families across the country. Very honored to have worked with senators holly and senator crapo with support of 61 of our colleagues the inclusion of these provisions the National Defense authorization act. Thank you both for that as well. Doctor bertagnolli the Institute Development Award Program plays a huge role in building capacity in Biomedical Research across the entire state of new mexico. For example the new Mexico Networks of Biomedical Research which are located on the new mexico State University campus provide collaborative Biomedical Research environment for more than 10 other institutions across my state. Despite the Program Targeting half of the country ida budget is. 9 of the overall nih budget. If congress were to provide additional funding specifically for ida, how would you as nih director expand the program . As they grow out their educational and outreach programs but also for programs that we have that are National Infrastructure such as the National Clinic network and literally goes down to individual communities. So it would be very welcomed and quickly apply into for action. I appreciate that. Do you support increasing idea programs, state participation across major programs beyond currently available mechanisms to programs such as those supporting biomedical facilities, instrumentation and training . Yes, senator. I view one way to engage the American People in the research that we conduct and i think it would be very positive i appreciate that. You touched on this with your previous response around Clinical Trial diversity and i appreciate your commitment to increasing Clinical Trial diversity participation, an opportunity still indiversity, workforce that itself is diverse, is better able to connect the diversity population in research. How would you ensure that nih is funding that reflect the people impacted by the studies conditions . Yes, thank you. This is a priority. It is a priority, why bus we know that as we have alluded to a Diverse Research staff like care staff brings us excellence, really brings Better Outcomes for the people that we serve. How are we doing specifically targeting programs to identify very talented individuals who come from diversed backgrounds giving them opportunities to the participate and then supporting them through educational and other support programs to make sure that they succeed and there are numerous efforts like this across all of nih and i would like to see this expanded even more. I appreciate that. Mr. Chairman, i have some other chairmans i will submit into the record and i will yield back. Second round. Yes, please. You said that you maintained the Biden Administrations policy for allowing Fetal Tissue Research but should only be used as last resort. How can you ensure fetal tissue is only used for last resort . Thank you, senator. Understanding the great sensitivity of many people and a passionate feelings of many people on the issue of fetal research. As confirmed as nih director my job is to serve everyone including the communities that care deeply about how that tissue are used. Absolutely, i would follow the laws of the land in every aspect and i would also followthe laws of the land trying to the achieve maximum for people. We are trying to cure major diseases, thats our highest goal but we need to do it with respect and let me ask. A slippery slope, the means are justified. The specific question how would you ensure that field tissue is only used as last resort . Thank you. I would follow principles of review and oversight over the use of this tissue which i understand is very stringent and ask that particular question as by the review boards as one aspect of approving its use. Now im going to ask you questions related to obesity. My state unfortunately is 50 of the 49th in terms of obesity. So im told that the amount of funding directly for obesity by the way, we neglect this, just for context, obesity is a major driver for Health Disparity thes disproportionately affecting the poor and those of color but also whites and major drive heart disease, cancer, covid19. We know that. Im told that the funding at nih that is specific for obesity is only 1 roughly 1. 2 billion a year. 2 of the budget but a major driver of Health Disparities and morbidity and things that you know and i know of. Funding for obesity is lagging way behind funding for other conditions relative to its impact upon society. How can we better address this issue . Would you commit to increasing funding for obesity . How do we better address the foundation foundational translation implementation of research for obesity . Thank you, thank you, senator. Thank you very much. I will say from my current position as the director of National Cancer institute obesity and the rising obesity epidemic is one of the major causes and we recognize this and theres been tremendous amount of work done by nci to identify the ideology of this, how obesity drivers cancer and how that can be can be overcome. So i cant speak to the way the funding has been distributed now but i can assure you that this is yet another one of those topics that does not belong in a silo and then the last thing i will say, again, stigma. Making sure that people who suffer from this condition respectfully included as being part of the solution to the problem. I accept that. Research center is funding thats stagnant and to increase that funding would be a place to start. Again, if we are talking about something which is driving cancer, heart disease, hip replacement, you name it, why not i used to tell my medical student, obesity is here and has hydrohead and we focus more on the manifestation than on the creature itself. If we address the creature itself we address all these. That seems to have been lost. If you could address that, that would be great. If confirmed i would be delight today work with you on this. I agree this is a very Serious Health problem that takes a multifaceted approach and agree that it is something that we need to work on and would love to work with you on it. Thank you, i yield. I knew senator that if we waited long enough there would be an issue we would agree on and obesity certainly is an epidemic, its impacting diabetes and host of other issues and something that this committee must and will deal with. Theres an issue that we didnt touch upon, i raised my deep concerns that there are many millions of americans cannot afford outrageous cost of Prescription Drug in the country and thats something that the nih must deal with. Millions of people throughout the world who are struggling to feed their families. What we find is thatoh the Prescription Drugs consumed are consumed in developed world, that poor people around the world cannot afford the medicines they need, may cost a few cents to produce, they dont get it or they die and they suffer. The sorry. Thanks. Last week President Biden announced that the u. S. Government would share some nih funded covid patents with the World Health Organization to expand access to law and middleincome countries. If confirmed, will you build on this commitment and make sure that medicines develop with neh dollars are accessible and affordable in law and middleincome countries, would you ensure nih technology be shared to developing countries so they can produce the medicines their people need at a price they can afford . Senator, i will i can confirm that i will i share your concern. I share your passion for bringing life giving care to not just United States but the world and i will work with you on this issue. I would hope that you would appreciate that in some cases these drugs cost a few pennies to manufacture and yet they are not getting it to people for whom it might be life or death. That is something that you will Pay Attention to . I can confirm that i will be very delighted to work with you on this issue, it is critically important. Okay. Well, thank you very much for being here today. That concludes our hearing. As a reminder the committee will have a markup next wednesday, 25th on this nominee and a few others. Questions for the record will be due tomorrow by 5 00 p. M. , committee stands adjourned. Subcommittee is just under three hours. [background noises]
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