Transcripts For CSPAN2 NIH 20240703

[inaudible conversations] thank you all for being here in the Senate Committee on health, education, labor and pensions will come to order. N, this morning we will be considering the nomination of dr. Monica bertagnolli to serve as director of the u. S. National institutes of health. And let me begin by welcoming dr. Bertagnolli to our committee. Committee. We look forward to hearing t frm you, and we thank you for being here today and i see you brought along a fellow wyoming or i hate. 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 have 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. But 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 sailing. We spend f almost twice as much per capita on health care 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 pay 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 of people get sick, they go to the doctor called doctorhe writes out a prescription. They cannot afford to fill the prescription the doctors right. How insane is that . But its not just the high cost of prescription drugs impacting individuals. In the largest hospital in my state of vermont, i dont think its terribly different elsewhere, the high cost of prescription drugs account for 20 of the overall budget for the hospital, and that drives insurance costs up as well. Prescription drugs impacting hospital costs big timee period 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 meddling as the the federal government not effectively regulated the price of prescription drugs, 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 enormous benefits, financial benefits, to some of the most profitable pharmaceutical companies in the country. For example, in America Today the median cost of new cancer drugs has gone up by more than 300 over the past decade, even though 85 of the initial foundational Cancer Research is funded by the u. S. Taxpayer. Weey are putting money rightfuly so into research to deal with cancer, and yet we pay outrageous prices. In c june of this committee released a report that found that the average price of new treatments that nihth scientists helped invent over the past 20 years is 111,000. In virtually all cases, american taxpayers are paying far more than peoplee in other countries for the exact same medicine that the nih and taxpayers helped develop. Here are just a few examples from this report. With Prostate Cancer over 165,000 for expanding what exact same drug 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 exact executive e purchased in uk for just 10,000. Product developed by u. S. Tax dollars. Gilead charges americans with nonhodgkins lymphoma 424,000 what exact andrc 30 can be purchased in japan for just 212,000. And the list goes on and on and on. We pay for the research. Drug companies to help the drugs, make billions then they charges charge as the highest prices in for the product. One last example. After receiving 12 billion from the federalal government, moder, has quadrupled the price of the covid vaccine, a vaccine of literally coinvented by nhi kiska 128. While the exact same medicine, same vaccine be available in europe for as little as 26. Really . Anybody here think that vaguely make sense . We develop the research, we pay for, we pay the highest prices and world. People can afford it. Doesnt w make sense to me. In my view at this very difficult moment for american healthcare, and we are in a crisis situation, we need an nih director who is prepared to take on the greed of the pharmaceutical industry and use every tool at his or her disposal to substantially lower the outrageous cost of prescription drugs. The 1800 wellpaid lobbyists from the pharmaceutical industry are all over this place, may not be happy about that thought, but that is precisely what the American People want. The status quo is not working. We need fundamental changes in the way the nih addresses the crisis of prescription drugs. We need d nih director who is prepared to reinstate and spent reasonable pricing clause to make sure thehe pharmaceutical Companies Set reasonable prices for new prescription drugs developed with taxpayers, et cetera, et cetera. A whole lot of thingss thelo nih can do. Will nih alone solve the problem . Of course the period of the agencies and administration have got to be active as well. You know, the media describes what goes on in congress with a very divided nation. While we are. But i will tell you this, whether you are a conservative republican got a progressive, a democrat when independent do you know wee on every poll tells us that, as is the American People want focus to do with outrageously high costs of prescription drugs. That is what weve got t do. Senator cassidy your recognize reopening remarks were thank you, chair sanders. Today the Committee Considers nomination of dr. Monica bertagnolli to be the next recognize as it of health. Dr. Bertagnolli, pennsylvania. Thanks for taking on this job and going through this committee which i know must be stressful, but again very pleased to have you. You have an incredibly impressive resume and i say that as a physician performing was an academic but as a resident that compares with yours. And its reflected by the support you from the scientific community. There are some questions regarding scientific qualifications, but their people double as questions regarding your overall ability to lead the nih in the next days, and this is what my remaining much will be about. Everybodyow knows nih role in strengthening americas Biomedical Research and supportingto Public Health especially during a crisis. Unfortunately, it became a lightning rod for partisan debates during the covid19de pandemic, and that eroded the trust between the nih and the public. First and foremost, you will be cast to rebuild the relationship with congress and the public. The leaders represents the interests of all americans and not just of the scientific community. This means making agency more transparent and accountable while also advancing cutting edge science. Effectively communicating to the American People and rebuilding trust with copy between Public Health officials and the Biomedical Research community. An extract was also protect and strengthen the valuable Publicprivate Partnerships that make up our Biomedical Research enterprise, and sometimes the 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 from stakeholders on modernizing nih, and this would include my i look forward to hearing from you about your vision for agency and how you shall achieve. Now during our meeting we spoke about bioethical issues including field tissue and embryonice Stem Cell Research ad the use of hormones and other transition, gender transition interventions of children. Frankly, a times you avoided getting to the specifics citing a lack of expertise. But as the director you have to have thisr, expertise. You will need to be prepared to weigh in on topics that are not in your research specialty, but across the entire enterprise. Making the policy decisions that will shape the direction of Biomedical Research. While you consult with experts and take input from your institute directors, you are ultimately the person who decides. I point out that this hearing is apparently happening today was not going to otherwise because of the Public Technology deal the Biden Administration cut with chair sanders to implement artisan drug pricing policies in exchange for dancing your nomination. The Biden Administration officials told us in a hearing earlier this year that policy similar to those in the deal that have been reported could risk of future partnerships between the government and the private sector. By the way, future partnerships critical to generating the cures important for cancer and alzheimers and for the next pandemic. Partnerships that are the foundation of the Biomedical Research enterprise which by the way leads the world in developing these cures. Its concerning the administration would jeopardize the longterm success of this enterprise for the short term goal of advancing your nomination. Last week i asked President Biden secretary becerra for full accounting of any deals cut with members of congress wanted to advancing your nomination. At 5 43 plastic, kind of the problem, at 543 time a class that i proceed basically a form letter basically a form letter that resided to information and intentionally ignored the request was supposed to responding to. The administration was not forthcoming about any deals with members of Congress Even though some of those details have been reported in the press. Now standard is expected to vote under confirmation should be aware of any such deal prior to the nomination. Thats not you hear its the process. And we speak about the breakdown of trust. Its like rhetoric inflammatory rhetoric which is true, true true not related. Is driving a process by the administration on something that we should know about but we are not being told. Another example, in june senator tuberville and i sent the acting nih director of that about nih funding cut nih funded projects that resulted in the death of two adolescence. We didnt get a response to that letter until september 15, week after the Biden Administration struck the deal to move your nomination. I believe you when you say that youre committed to transparency and rebuilding the nihs relationship with congress. I appreciate that commitment body have concerns given the administrations history i failed to respond to congressional oversight requests, particularly for members of this committee who are responsible for that oversight. So rebuilding nihs relationship with congress will require a strong director who can overcome partisan divisions, overcome the administrations delivered stonewalling of requests to members of this 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 will directly oversee your work as an agent director, if youre confirm. Ir i look forward to hearing how you shall fulfill these parts of the job and move the nih forward. I thank you and with that i yield. Thank you, senator cassidy. I now would like to welcome our nominee, dr. Monica bertagnolli fso district of National Cancer Institute Since october 2022. Prior to the role doctor bertinelli was a surgeon at brigham and Womens Hospital and professor of surgery at the field of surgical oncology at harvard medical school. Dr. Bertagnolli is a longtime member of the American Society of clinical oncology wishes service both president and a member of the board of directors. I thanked her for being here today and after over two store John Barrasso to introduce her. Takes a much mr. Chairman and a pleased to welcome to the senate and to the committee dr. Monica bertagnolli was a fellow physician and the wyoming native. President biden is nominator to be the director of the National Institutes of health. It certainly not every day that one of wyomings their own is nominated for such a high position in our nation. Dr. Bertagnolli has devoted her entire life to medicine and medical research. She earned a bachelors degree in engineering from princeton university, graduated from university of utahs medical school and later surgical Residency Training at brigham and Womens Hospital in boston. She went on to be Research Fellow in tumor immunology at the Cancer Institute in boston, she later served as the chief of surgical oncology for over a decade. Shes continued caring for patients at brigham andor Womens Hospital while being every now and Cancer Researcher. She is also serve as a professor in surgical oncology at harvard medical school. She strained that only the next generation of doctors but also Cancer Researchers. And thises makes her a perfect t to serve as our current director of the National Cancer institute. While many may know that she is a wellrespected physician and researcher that she is, wyoming no, sir as part of a multigeneration ranging family. And a proud to say that she has never forgotten where she came from. As i have traveled and met with folks across wyoming and the mountain west, ive heard of her great work not only as a doctor the ranch. So that includes the rage and neighbors. If you want to know somebody you talk to their neighbors and arranging neighbors. They speak of her grid, her endurance and her determination. Her commitment to the land and livestock speaks volumes about her character and her courage. She understands the needs of rural health and frontier medicine. She has used her background, medical as well s as the values she learned growing up, to improve healthcare allamericans shee serves as an advisor to the huntsman Cancer Institute in Salt Lake City utah which is a designated Cancer Institute wyoming. She also advised huntsman on how to reach patients in rural areas. She focused on reducing burdens on patients by using local Cancer Treatment clinics. One is in Sweetwater Regional Cancer Center in her hometown of rock springs wyoming. Our firsthand experience in accessing health care in Rural America gets her a perspective that is often lacking in washington pick she has an extensive track record of cultivating privatePublic Partnerships to push medical innovation forward. This back when will serve her well as the director of the National Institutes of health. I have immenseha appreciation ad admiration and respect for dr. 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 Government Agencies such as the nih has attacked Health Innovation through the inflation reduction act. I think its important that this position be filled with someone with a critical and an open mind ready to tackle the important challenges ahead, and for all these reasons, mr. Chairman, i support the nomination of doctor Monica Bertagnolli to Service Director dinesh institutes of health. Thank you, mr. Chairman. Thank you, senator barrasso. To be italian to be for my only question what im saying . [laughing] well, in a bipartisan way mike enzi, republican. If there a former congressman, tito who was also from rock springs, wyoming, so it helps. [laughing] okay. With that introduction, dr. Bertagnolli, the stage is yours. Welcome. Turn the mic back on, please. There we go. Chairman desantis got Ranking Member cassidy, and members of the committee, thank you for considering my nomination to be director of dinesh institutes of health. T 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 h so i would 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 and transgender youth after two years of hormones. According to the letter nih and sent to Ranking Member cassidy and the the research seeks to understand the physical and psychosocial effects of medical intervention e to evaluate the effectiveness of existing medical treatments already inn use among transgender youth. As you know two young people committedav suicide who were pat of this study. Thats obviously a tragedy. But what concerns me even more is the fact that the nih was funding this research, and beyond that i believe the nahb recalled the study a success. Thats sick. It sounds to me like in a h totally dropped on loan to control and oversight. So if confirmed, how would you make sure nothing like that ever happens on your watch . So first, senator, i really thank you for your affirmation of the critical importance of nih and what we are here to serve the American People and just a critical that is unimportant this job is. And to that end, in response to 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 health of all. But that, number two, any research that a we do that involves human beings, people, 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 of maximum respect for the dignity of people. If confirmed as nih director i will affirm to you that that will be my load of action and my highest priority for all human research. Thank you. One more quick question god chairman. The nih used to be universally respected, nonpolitical organization before 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 rural perspective and to understand just how much people in his parts of the country in particular i have lost confidence in our Public Health institutions. They feel totally overlooked. What would you do as nih director to help gain back some of that respect in rural areas . Thank you so much for the question and ian will be very brief. Two things. Number one, i believe deeply in the doctorpatient relationship. That is an incredible value. That is trust. A patient comes in put their life and hands and her health in the hands of their anything that we can do to strengthen the doctorpatient relationship is something that we should pursue to the fullest extent possible. And in second, i believe in education at all levels. And relating, our patients joining us in research to the fullest extent possible. Not science here and people here, the people joining us to do sites. I think that also engenders great trust in the process if its done and respectful and appropriate way. Thank you. Senator kaine. Thank you chair sanders andnk congratulations, dr. Bertagnolli. Im happy to support her nomination. Onbe every time a representative of the nih comes before i asked for an update on the Recovery Initiative. On this provided an h with 1. 5 billion in funding to advance understanding prevention and treatment of the longterm effects of covid, including long covid. This is a topic to report 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, former senator or former colleague store and off, senator young have talked about long covid experiences. My wife went to a lawyer last friend of ours to upper bound for bankruptcy because her treatments for long covid that knocked out of bounds that lever in a situation where if you doesnt file for bankruptcy she could losecy her home. I was at an event monday and a technology ceo came up and talk to me about his wifes experience with acceleration and deceleration of her heart rate which is fairly common long covid symptom. 5. 3 of americans now have long covid and of those, that group got 80 suggest that the long covid significantly limits life activities. The american steep in a Research Come nih to help understand how to treat, cure, prevent, symptoms that are often debilitating. And it frustrates and saddens me to hear how long many different how long covid folks d are dealg with it both had a negative impact on the life but often face skepticism in disbelief as they described their symptoms to employers and others. And im also frustrate one here long covid suffers indicate nih isnt doing enough on issue and that their voicesg are not being heard. Let me say what Patient Advocates tell me. Nih is in considering the input of those living with long covid and design and moment of Clinical Trials, that inn the ae is not as responsive as it should be to advocate outreach. That with recover being spread across multiple institutes is a lack of clear leadership in the initiative lacks, a point person that is held responsible for decisionmaking. There is a lack of transparency in the budget and future plans for the initiative. Dr. Bertagnolli, i know your book and could work and a chance is to up with you directly into the space, and so your knowledge of the inner workings of the Recovery Initiative are limited at this time. But should you be confirmed as director asked you continue to work with me to address the concerns of those living with long covid, including that you commit toit me meeting with Patient Advocates to discuss these issues. Senator kaine thank you very much for the question, and i can absolutely confirm that 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 from the people with lived experience community, call them the Patient Advocates. And i love that expression because it really is the way we need to do our science. It not only are we then serving the because were listening to them, but all the other issues of trust and accountability and respect for the peoplet we serve happen when you do that. So you hit something that goes to my court and i would be delighted to work with you. Thank you veryo much. Next topic i want to ask you is pediatric Cancer Research. Along with senator moran and 13 other bipartisan members of this body, of this committee and the full body, we introduce a bill called the Gabrielle Miller kids for Research Research to pointed to row thrice a program that is aimed at combating Childhood Cancers. The legislation is the result of continued efforts by the Miller Family to fight Childhood Cancer. And their revelation to me ten years ago that of the nih research budget, only a very, very tiny percent, lesson 1 was devoted to Pediatric Research in the cancer space. I am pleased to say the bill was voted out of the Committee Last month with a very strong bipartisan support i know you are familiar with the challenges in combating Childhood Cancer in particular. As congress looks to reauthorize the Critical Program can you tell me how nih will continue to expand its efforts using data to speed up research particularly for childhood diseases such as pediatric cancer . Yes, thank you. And this has been a major focus of my work since coming to nci and absolutely will be carried over at nih. And they just since time is brief, the beautiful, beautiful Gabriela Miller went to look into the camera countries in camera and athe paraphrasing of november exactly which looked in the she said quit talking, get working, or Something Like that. That just gets to your heart and we take it very seriously. Thats what inspires us to go forward. Thank you very much. I yield back. [inaudible] i defer to senator marshall. Thank you, senator cassidy. Trejo want is meant for the record first an oped in the Washington Post april 11, 2002, by a democratic senator democrat senator from the great state of indiana, senator birch bayh and, of course, one of my boyhood heroes the late great senator bob dole from the state of kansas. Its an oped about the buy dont dole act im sure you with this that this encourages entices a private practice to seek private research. It can firmly commit today to uphold the integrity and intent of bayhdole . Thank you, senator. And it confirm i will commit to uphold the integrity of the bayhdole act. Thank you. Next i want to talkou about research. In 2022 no two no half of all nih underwent institutes in just five states and happen to all be on the coast. I think that when we send all research in one or two geographical locations, your incest, you have decreased randomnessss of thought and it pickles things up. University of kansas Cancer Center second to none cut nci designated comprehensive Cancer Centers in 2012. The Kansas State University received in a ton in 21 to support it becoming a national ileader in emerging infections. Childrens Mercy Research institute in kansas city advancing the genomic Medicine Development of Behavioral Health and pediatric brain Cancer Research. Will you commit to actually correcting these issues so Innovative Research in the midwest are equally prioritized . Thank you, senator. Not only will i commit, i can give an example of where my past work as a retry to achieve this. When i ran a Cancer Clinical Trial group, one of my main goals was to make sure those trials reached as many communities as he possibly could. And we partnered with a wonderful physician practice in laredo, texas, serving the border community, a wonderful physician who served the community at pine ridge indian reservation, and a wonderful oncologist of my own hometown of rock springs, wyoming. So i agree with you completely, in each research has to reach everywhere and there are many, many centers of great excellence that we should have the ability to engage. My next question is a lot tougher one. Dr. Bertagnolli, you and i both protect a very honored profession. When itnk think about the horros of medicine, the great horrors of medicine, the things we got wrong, you think of bloodletting. Im afraid that 100 or 200 years from now those same the hiso going to go back and compare irreversible mutilation of adolescence for transgender surgery, irreversible cut emphasized. Giving them irreversible medication that is going to be one of those two horrors there could be talking about. They will be talked about bloodletting and the glorification of disfiguring surgery for people that 80 of the just and a couple more years once they have had some hof their own are t going to say mae it wasnt a good idea. Before you answer this question i want you to think about the oath that t you and i took. Its way over quota but it is but ill do no harm. Above all, do no harm. So heres my question, should Taxpayers Fund gender reassignment experiments or research that a purely cosmetic, destroy healthy tissue and organs, or when the use fda approved products offlabel with significant negative irreversible impacts . Again this offlabel use is ines treating diseases or illnesses. Should taxpayer funds be used to do research or fund these irreversible, horrifying, irreversible procedures and the use of these hormones offlabel . So senator, thank you very much because its very clear that you are, share my concern over the wellbeing of the lgbtq community, especially young vulnerable people. What i can tell you is that if confirmed i will commit to leading nih to conduct the research that will achieve the very best health for these vulnerable and special sorry to cut youor off, right there cant do you believe that its okay to fund this type of research for these irreversible procedures are beingse done . Do you think there is any, any experiment that you can think would justify irreversibly damaging these poor little boys and girls who are 14, 15 years old . Will you find that 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 that are participating in the research. And that will be the principal with which i approach any research, especially for this vulnerable population. Thank you. I yieldld back. Store smith. Thank you chair sanders and Ranking Member cassidy. And thank you so much, dr. Bertagnolli, for being here. Its wonderful to see you again and 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 i would like to actually follw up on something that senator barrasso started with an focus on, which is your personal experience in wyoming, experience in Rural America. Im not going to ask about the rent although i would be tempted to. But i think it meshes with the very clear policy interests of mine, which is around our world health and a focus on rural health. We know in Healthcare Settings across the country theres a a real shortage of healthcare workers and that this effectively felt particularly intensely in Rural Communities that are struggling to maintain hospitals and making access to care. 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 well, thank you so much for that question. You know, our job is not done if we just produce an effective treatment or an effective approach. Our job is not nearly done. Our job is only done when people are living long and healthy lives and so that means that a critical area of nih needs to be health care research. A quick personal note. Town where my parents lived in central wyoming, no hospital within 100 miles through city, through state, community, federal and tribal participation, theres new hospital being built there and i am committed to seeing that new center, in that new location being brought into the Research Enterprise so that we can understand how these kinds of federal, state, tribal, Community Partnerships can be brought to bare to be able to deliver better care, just one example. And i appreciate with youre highlighting, which is the importance of partnerships, but the importance of nih attention to training and Research Opportunities in Rural Communities because i think theres a lot of good data to show if you were trained in a rural place and youre much more likely to stay in that rural place and there are good best practices how to do that and i have to say that i share senator sanders concerns about challenges delivering care in this country. So i think theres lots for us to work on there. Another area that i wanted to touch on before i wrap up is the importance of focusing on research around Mental Health care. This is an important issue for me. Less than 5 of the nih budget goes to the institute of Mental Health. Less than 5 well, one in five of americans are going to experience Mental Health issues and we know that Mental Health and physical health, its brain health and the rest of your body health. So could you talk a bit about how you view the nihs role in focusing on that connection between mental and physical health, brain health and the rest of your body health . And given this low percentage of funding, how can the nih advance research on Mental Health . Oh, thank you. I think, first of all, Mental Health affects every single disease we treat. It effects how someone can manage their cancer journey, it affects how somebody who has got kidney failure is able to get the needed care. It affects every single thing we do. So one of the things im really excited about, if confirmed and taking on the role, is to really focus on the interactions between the various institutes where there are common themes that need to be addressed and even in order to treat the individual diseases. Mental health is overarching sn really needs to get into every research institute. Thats number one. Number two, that will help us best leverage the funding that goes into the Mental Health institute and being able to pull on that through resources throughout the entire nih. And thank you for your advocacy in raising this really important issue, raising awareness. Thank you. Thank you very much, mr. Chair. Thank you. Senator . I defer to senator budd. Thank you, Ranking Member, mr. Chairman. Doctor bertagnolli, thank you for being here, and congratulations on your nomination. Its a great state that you come from. Research tells us that children in the womb respond to and that they can feel pain at 12 weeks and fetal anesthesia is recommended for surgeries at 13 weeks, so doctor, before obtaining consent for a fetal tissue donation will you commit to requiring nih contractors and grantees that they explicitly inform mothers that their child will feel pain during an abortion by 12 weeks of pregnancy . Thank you for raising this issue, senator. I believe that the policies and procedures that governor any research with fetal tissue prohibits any discussion with the mother toward even the possible use of such tissue for research. So, it would not be acceptable for me to affirm this, that interaction is not allowed to take place. Thank you, mr. Chairman. I yield back. Senator hassan. Thank you, mr. Chairman and thanks to you and Ranking Member cassidy for this hearing. Dr. Bertagnolli, its so good to see you and congratulations on your nomination. Thank you for your willingness to serve. I want to follow up on a line that you heard from senator murray and just now from senator smith. The National Institute of drug abuse on nih plays a vital role for emerging substance and addiction. For medication for use of opioid disorder and evidencebased to treat addiction. As a result of nihs leadership, its now widely accepted as a Gold Standard of care for those struggling with opioid use. Last year i worked with senator murkowski for the mainstream addiction act which eliminated an unnecessary hurdle for those providers prescribing this. Despite the push to increase Access Research shows that high levels of stigma and lack of provider education still stand in the way of individuals receiving medication assisted treatment. Doctor, can you tell us how you will develop strategies to eliminate the stigma around medication assisted treatment . Oh, thank you for that question. And yes, i think that the the overall issue of Substance Abuse is, first of all, its a tragedy and second of all, that tragedy is compounded when on top of it theres also stigma associated with the disease, so that stigma needs to be combatted at every step. I also falls back to what is the first and most important relationship thats the treating physician and the patient together. I think trust between those two individuals is absolutely key, trust and support. But then i think we also can do more to raise community awareness, you know, in every regard and this is yet another area of whats the best way, the most respectful way, the most appropriate way to Garner Community support for individuals battling substantial abuse. This is another really important area of research to make sure that we know how to do it respectfully and well. Well, thank you. Will you commit to continuing to grow the National Institute on drug abuses work for treatment on Substance Abuse disorders . I will commit to work with you to end the scourge of Substance Abuse. Thank you. I want to move to a different topic, antibiotic resistance is serious emerging threat to global Public Health. In july, you and i discussed the nihs 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 unresponsive to current antibiotics. How do you envision nihs role in the Publicprivate Partnership to combat microbial resistance . Certainly, this is a critical issue for Drug Development which has been successful to a certain degree in being able to head off the continual problem of Antimicrobial Resistance and i fully support any research that can help us get to that aim for people. Ill also add that like virtually everything we do in medicine, there is also a social and an educational component to this, its not just finding a new drug to beat the bug, its making sure to prescribing practices for antibiotics or use in agriculture, all of these other efforts that really are can be make the pro worse and perpetuate the problem also need to be an area of our research to be able to combat. Well, i thank you for that. Are there other new strategies that you could be looking at to improve Clinical Trials for new antimicrobial medications . I understand the last point you made, but i think we also need to make sure that were continuing the research so that we have new classes of these medications. Yes, thank you. This is a very important issue for Clinical Trials. I will also just take it as a side to say, we have so much work to do in the Clinical Trials arena and one of the other commitments i want to make for Clinical Trials since its been one of my core expertise. Faster, more inclusive and more responsive to the needs of people. One of the major issues that i would like to see happen at nih. I appreciate that. I also want to look forward to working with you. Im interested in bipartisan issues support antimicroial research and look forward for this goal. Thank you, mr. Chairman. Ill deter to senator murkowski. Thank you, doctor, for being here and appreciate the response you just provided to senator hassan about Clinical Trials. I am very invested in and very focused on what is happening within Clinical Trials for als. Ive got a personal connection, i think, so many of us do have a personal connection and we recognize just really the horrific progression of that. And i will submit to you a pretty specific question about how we can make als Clinical Trials more efficient, looking for, perhaps, alternative sources to better or more precisely measure als progression. But it is, what you have just said about leaning into this and placing a priority on it is something that i appreciate and id look forward to further conversations with you on that. Youve already responded to questions i had, senator smith asked about rural health and thats something that coming from alaska, we would certainly encourage Greater Research in in rural areas that dont have care delivery sites. One of the other issues that i wanted to bring up was what senator murray raised with menopause research. I was able to meet with advocate a few weeks ago and shocking to me to know that one of the life stages in women, whether you like it or not, is menopause and how little we actually know about the impacts and many of the treatments for health for Adverse Health conditions that are associated with menopause in particular. Let me ask my question about Infectious Diseases. We in alaska are plagued and have been for a long period, but it continues throughout our state. We see preventible chronic Infectious Diseases, particularly tuberculosis and hepatitis c. As of 2021, alaska had the highest incidents 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 just solely and specifically to monitor what were seeing with hepatitis c. So i would ask how the nih would approach cordnating with other federal agencies, whether its the state, the local, the 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 where we see rates that are, in my view, beyond intolerable. So whether there are possibilities for cheap point of care testing for sti. Talk to me a little about what progress we could make or what we could hope for. Oh, yes, senator. I was not an Infectious Disease specialist and i was not aware of the citizens of alaska. Its rough. I can comment briefly though and say that certainly for hepatitis c and tuberculosis and perhaps even for sexually transmitted diseases, the two keys to managing when its prevalent within a population, diagnosis and hepatitis c can be silent for decades and people dont realize they have it and the same with tuberculosis. Many work places have routine screening. Certainly in a hospital you get screened every single year and its through the screening and to identify individuals that need treatment are really important part of control. Instituting the best approaches for that, again, i have to deter to colleagues who are experts in infection control, but i would be very pleased if confirmed to work with you to address these specific issues for the people of alaska. Well, and we do have some great experts that are on the ground who are very familiar with this, but its the coordination that im hoping that we will be able to see between federal, tribal, state, local. Thank you very much. Thank you, mr. Chairman. Mr. Chairman, thanks very much. Dr. Bertagnolli, 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, ive led the annual bipartisan proegs appropriations letter. Most recently working with senator tillis on a letter that was joined we were joined by 56 other United States senators. At the end of that letter, this year, we say, and this is just, quoting one part of the letter, quote. If were 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 offer an economic return for our nation. So were proud to be able to do that and continue to advocate for robust funding for the National Institutes of health. I dont have to remind anyone the reach and the scope of the National Institutes of health. They literally touch the lives of every american and were at a time where theres both enormous potential for advancements in health science, but also, great, great challenges, such as the risk of disinformation, and the decreased trust in medical experts. The National Institutes of health in my home state of pennsylvania, provides tremendous value despite those challenges that i mentioned. Pennsylvania researchers successfully compete for thousands of grants each year, totalling over two and a half billion dollars. The funding directly supports more than 28,900 jobs in pennsylvania and also, contributes to a thriving life science sector in the stake. So we have a lot at stake as a commonwealth, but also for our country. And i want to commend the work that youve done at the National Cancer institute related to pediatric cancers, diseases which were almost universally fatal decades ago, but which are largely survivable thanks to investments and research. If we work to confirm how the nih is continuing to invest in Childrens Health and that children are being appropriately represented in clinical studies. Yes, thank you very much for that question. You know, there has long been i think i can you recognize that children have been definitely understudied and certainly, the conditions that effect them have not been not received as much attention from the pharmaceutical industry as some adult diseases. What can we do at nih . A couple of things. First of all, recognizing the importance of developing collaborative mechanisms that bring pediatric cases together for study and knowledge. You know, pediatric many pediatric cancers are Rare Diseases and one of the great successes that weve had at nci has been to bring together a community of patients, researchers, and caregivers around bringing together data from those taking care of pediatric cancer cases across the nation. But it doesnt obviously stop at nci. Every single Disease Center needs to focus on the youngest americans making sure that we address their needs with Clinical Trials that are targeting, targeting the diseases. And last thing ill say all of us need to prevent. Prevention has to start when were children, right . So not only targeting diseases that kids have, but targeting new strategies to make sure that they get the preventive therapies that can last a lifetime. And one of the strongest ways we can influence their health overall. Thank you, doctor. I want to ask you about the work that ive done with regard to rare disease patient groups over the years. One challenge thats come up repeatedly difficulty demonstrating a potential therapy is effective due to poor natural histories of those of these rare and ultra Rare Diseases. Can you talk about the role that nih can play to support research into Rare Diseases for our understanding for save and effective therapies . Yes, senator. I can give you a specifically example of this one. The Nih Clinical Center is an absolute treasure. Theres a program at the Nih Clinical Center today that i can speak to most easily because it has to do with pediatric cancers, that takes very rare pediatric people with very rare pediatric tumors, assembles a team from basic biology to Clinical Trials, importantly and have partners, Publicprivate Partnerships and partners to bring together a community to be able to treat that disease. Those individuals all come to the Clinical Center so that throughout the nation, its incredibly moving when you see people who have a rare disease or children with a rare disease, their families there for the first time meeting another person who has that really rare disease, its an incredibly moving experience. And that community built around that, centered around our Clinical Center is making tremendous progress. One by one. Id like to see that model scaled dramatically. Thank you, doctor, thank you, mr. Chair. Senator. Okay, dr. Bertagnolli, i have a lot of questions, if i interrupt you please be tight with your answers and if i interrupt you i apologize in advance. You said in your staff interview you support the reasonable pricing clause included in the recent contract with barta, but you were not familiar with the nih experience in the 90s. The Clinton Administration and director stated when rescinding the policy extensive review the pricing clause has driven industry away from potentially scientific potentially beneficial scientific collaborations and eliminating the clause promotes research that enhances the health of the American People. Research america and alliance of hundreds of organizations advocating for Biomedical Research expressed concerns about the policies that would quote, discourage the uptake of breakthrough, discourage the breakthrough of uptake of discoveries by the private sector, this would be detrimental. Would you have pricing clause if confirmed . My utmost priority would be securing treatments affordable so thats not my question. Would you apply reasonable pricing clauses to contracts . I cannot commit to. Im asking you to commit to not an action. I would work with you, to make sure that people have access. My concern is based upon the doctors experience, if you institute, youre going to stop the translation of basic research to taking care of patients. This is noting is that we need to pussy foot around. History tells you if you do it, patient would be damaged despite rhetoric out there. I would hope youd be more forthright in embracing this issue. Weve got science evidence, my gosh, if were doctors, not listen to the rhetoric. I know that patients are going to be damaged by this. I dont want to rag, but i just get frustrated. Okay. Also, what about rights, you mention you want to lower cost and your predecessor collins said during the tenure, they dont have rights for march in rights to lower prices. If you use it only for lower drug prices. Do you support march in rights to lower drug prices, quote, unquote. Again, i cannot commit to any particular policy right now. That is though, it specifically says in the law youre not supposed to use gives you three ways to use it, one does not include lower drug prices, i mean, were asking you are you going to follow the law . That would be the action . I will follow all the laws of our land certainly and again, my goal will be to make sure that people get pt treatments they need. With that, it sounds like your answer to my previous question you wouldnt do the other thing. Secretary becerra, an Advisory Board for fetal tissue for appropriateness during the previous administration, and presumably a panel like this would help achieve what you tell me your preference is of ensuring fetal tissue is only used as a last resort. I am told there were members of this board who supported fetal tissue research, but still rejected some of the Research Projects put forward by nih for the boards review because of a lack of informed consent. Now, you stressed the importance of informed consent in an earlier answer. These pro fetal tissue advocates rejected these proposals because of a lack of informed consent, but effect becerra has discontinued this board providing that safeguard. Do you degree with secretary becerras decision to discontinue this board . I do not have enough information on to comment on the secretarys actions. What i can confirm for you, any Research Need to be conducted according to the most stringent i accept that, but the board rejected some of those, mechanism by which you were telling me was actually executed, the informed con stent was not done. If we skip mine as a theoretical and what i laid out were the facts, would you support reinstituting the board . Again, i cant comment on the specifics of that activity. I would say if confirmed i will uphold the principles of ethical human research. Four years almost since the covid19 pandemic began and we still dont know where the virus originated. Many studies reports explored plausible alternatives, experts agree that further research is needed. Do you believe the federal government should do everything it can to determine the cause of covid19, including the possibility emerged from a lab that was conducting gain of function research . Ranking member, cassidy, i think no one was to know what the true origin of the last covid pandemic was than the how would you accomplish that . To the fullest extent of our ability to gather the data and have access to the data and make a valid making it public . Make data that we have availability available public and accountable to the American People, yes. I yield. Senator. Thank you, mr. Chair. Dr. Bertagnolli, welcome to the Health Committee and congratulations on your nomination. A number of us on the Health Committee are also on the Appropriations Committee and i want to address the budget for the fiscal year 24. Despite the challenges that we had faced in writing, labor hhs appropriations bill, because it included the availability of less funding overall than we had in fiscal year 23, i our bipartisan fiscal year 24 bill builds on our longstanding commitment to nih and Biomedical Research in general. We secured critical increases in our bill some of the agencies most important programs. 100 million increase for Mental Health research. 100 million increase for alzheimers disease research. 60 million increase for Cancer Research. And 12 million for a new Palliative Care Research Program. As a Cancer Researchers, i wonder if you can describe how the recent investments in nih and specifically Cancer Research have advanced care for patients and improved outcomes, but i also want to have challenge you to talk about the impact that the house passed im sorry, not the house passed. The house bill thats pending, that has drastic cuts in Biomedical Research, how would you tackle that if that became law . So, thank you, senator. First, let me say that i speak for everyone at nih to say that we are deeply grateful for what we receive from the federal government in order to conduct our research, and then number two, let me speak as a physician to say over my 30plus years of being a physician, i have seen the tremendous advances that have been made as a result of nih funding. Im not going to to take down the clock in the many advances that have happened in the last years, just let me assure you that people are living better, longer as a result of nih research. I think that you are also asking to address how changes in funding will impact what we do. I will just say that every penny we get, we will use to the fullest extent possible to secure health for the American People. We will focus on the issues that congress brings to us as important, and i really embrace working with you on those key issues. And then finally, if our budget there is a chance that our budget will force us to leave opportunities on the table because the opportunities are enormous and ill just leave it there. Okay. There have been two biosafety incidents involving the h5n1 virus at university of wisconsin and there was an oversight from nih which i find very, very concerning. As chair of the labor hhs appropriations subcommittee i work for language and funding focused on this issue in our bipartisan fiscal year 24 bill. In addition to directing nih to articulate the roles and responsibilities of investigators and institutions conducting this research, the fiscal year 24 bill would establish for the first time an office at nih to serve as a resource and to provide tools and guidance to the research community. Dr. Bertagnolli, what steps would you take to enhance the oversight of nih Funding Research involving potential pandemic pathogens . Thank you very much for your advocacy for this very, very important issue. You know, potential Pandemic Pathogen Research stands to achieve great benefit for people by allowing us to respond immediately and save lives, but it also has risk. And i can commit to you, if confirmed as nih director, that i will fulfill the highest possible oversight for programs that engage in this kind of research, review and oversight to make sure that they are conducted safely and achieve the benefit we know we can see for the American People. Thank you, mr. Chair. Senator markey. Thank you, mr. Chairman very much. Let me just begin by saying that lgbtq people are living in a National State of emergency more than one in two transgender and Nonbinary Youth have seriously considered attempting suicide. When elected officials use their bully pulpit, gender affirming care, evidence based life saving treatment and the youth Mental Health crisis. This is driving forward a nationwide campaign of discrimination and it is unacceptable to lgbtq youth, young people. Let me just say this very clearly, trans rights are human rights and im never going to stop fighting for essential research and investments in the care which you need to make sure that everyone is free to exist as their authentic severals and until you can live freely and safely. Ive heard from many people from massachusetts including many oncologists about your excellent work and your leadership and its clear that you have a commitment to Public Investment to try research that will improve americans health, treat illness and to cure disease. Last Year Congress passed my bipartisan children and Media Research advancement act, requiring the National Institutes of health to conduct research on media on infants, children, adolescents and provided the nih with 15 million to launch this program. We already know that big techs exploitation of younger users is driving a Mental Health crisis and this research will further document the serious harms caused by the Online Platforms insatiable appetite. And will you prioritize that . We have a Mental Health ep deppic amongst teens. Thank you. As a parent of recent teenagers, i can comment about the great concern the amount of time spent in front of computers and worry of a parent as to what that really is doing. I can commit to you that this is a very important issue for nih research. Understanding what this new Technology Means for our young people, really, everyone, but certainly more of a focus on the young and i also know that this is an issue that is a great concern for our Surgeon General and i also look forward to working with others across hhs on this issue. The Surgeon General has identified the problem, senator cassidy and i have already have coming out of the Commerce Committee successfully and upgrade of the protections for kids online, up to age 17. And were hoping to move that on the senator floor. But we also need the documentation from nih as to the underlying pathology which is being created as we sit here right now. Since the passage of the National Alzheimers Plan act and alzheimers accountability and investment act that senator collins and senator warner and i have worked on, nih research has contributed to significant advancements to understand and treat alzheimers, yet, we have a ways to go. We are just continuing to understand the impact of air pollution and Environmental Justice on the brain, back, brown, disabled and Rural Americans face discrimination to barriers access to treatment, including long travel times to care and family caregivers still struggle every day with providing care to their loved ones with alzheimers. Doctor, can you just tell us how you view the nihs role in continuing to lead Alzheimers Research in 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, senator for that question. It raises many issues that ill just go back to maybe my core approach to things such as this first. Understanding the biology of what has produces this condition and that means going all the way back, maybe even to the very early years of life, so that we can think about prevention, rather than treatment. Thats really critical and encompassing a very broad population of people to inform that. Next though, 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 youve already said, it is part of nih to think about care delivery and that means, delivering for the caregivers, taking care of the caregivers, because theyre a really important part of what helps us achieve health. Thank you. And our goal is to increase funding for nih researches, medicines, field of dreams, from which we harvest the findings for hopes for families to find a cure for alzheimers and nih is really the National Institutes of hopes for the alzheimers families. Thank you, mr. Chairman. Thank you, mr. Chairman. Last week, the House Oversight committee subpoenaed acting nih director tabek for documents relating to the investigation of dr. Morans. Dr. Morans, a top advisor to dr. Fauci is accused of using a personal email to avoid public accountability and according to him, delete anything he did not want to see in the New York Times regarding the origins of covid. Subcommittee released emails allegedly from morans, 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 you, senator braun. I can assure you i take congresss responsibilities for oversight for the nih and if confirmed, my responsibility as director of the nih to be compliant with policies regarding that oversight, extremely seriously. I can confirm that if i assume the position to be accountable and transparent and to work with you to resolve these important issues. Have you ever spoken to dr. Morans about the covid19 pandemic . No, senator, i dont know dr. Morans. And will you commit to not use a personal email for official nih business or to try to shield conversations from the American Public . Yes, senator, absolutely. And also, id like to comment before ive got one more question for you. Senator holly and i actually passed legislation asking the white house to release all the material they hold in classification on the origins of covid19. Theres a wall out there and they have not complied with that. Were still trying to get them to comply with that law and remember, youre working for that administration. So 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 and youve sat on the board of several companies receiving Stock Options and bonuses. Our country relies on its Public Officials to have their best interest in mind when performing their duties as public servants. How can the American People be sure that as 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 that the funding that i received from pharmaceutical companies was to conduct research, that none of that formed my own personal salary. The only salary i received during that work was from brigham and Womens Hospital, a salary hit based on my academic rank. I have one instance of receiving a payment directly from a Pharmaceutical Company, it was for service on the board of directors of a single Pharmaceutical Company and so, but finally, the more important question, i completely agree with the need to have one goal, one constituency that im serving and thats the health of the American People. Thank you for that. One quick final question here. I think youve signed an agreement with senator warren about what you might do after this post and from the information ive got is that you wont seek employment or compensation from any Pharmaceutical Company. Is that correct . And does that mean then, if you do, you will turn down those offers . I well, the agreement with senator warren is designed to assure the American People and congress that i will act with the goal of the very best interest of the American People if confirmed for this job and i have agreed for a time of four years after stepping down in government, that i will not accept employment at a major Pharmaceutical Company. Thank you very much. Senator hickenlooper. Thank you, mr. Chair. Thank you ms. Bertagnolli, appreciate your service and be willing to step in at this key time. Emerging technologies, ai, is top of mind. Theyre becoming ingrained into various parts of our lives, the health care is absolutely no exception. Ais prime to assist with trial design, realtime monitoring, predictive analysis, go down all the different aspects of Clinical Trials, which are so expensive. I think we all have agreed over a long period of time that the cost is a barrier to progress. So dr. Bertagnolli, do you think that the advent of ai will help create efficiencies in our Clinical Trials or pitfalls to be mindful in trials . Yes, thank you very much for that question. Machine learning approaches, Artificial Intelligence are really wonderful new computational methods that were all very, very excited about. You know, weve long had the scale of data that we just do not allow us to analyze it properly. However, the more we learn, the more we use these techniques, the more we realize they have to be like any tool, used in a very careful and responsible manner, particularly when it comes to human research. So the short answer is, yes, absolutely. This is very exciting, but with a qualifier that the design and conduct and type of data used to train these models need to be very, very carefully considered to make sure were getting the results that really matter and are meaningful for all people. Any specific pitfalls, youd want to put on the record . You know, i think that the the most serious one that we hear about a lot is an ai method that might be designed and trained on one particular ethnic group, and then gets a result that continues to disadvantage others who need to be included in that kind of research. I think thats one really serious ones, but, you know, there are many. Its a come computational method after all and it has to do with we want it to do. The its not as transparent as some of us might like. Exactly. Harvard and brigham and Womens Hospital created a multiregional Clinical Trial center, obviously, youre very familiar with given your time at both institutions. The centers prime focus, improving the safety and efficacy of Clinical Trials and they train from dozens of countries, what is good clinical process and good clinical practice. This leadership, i think, is critically important. Often underestimated, the significance of it. We live in an interconnected, wonderfully diverse world, but that interconnectedness and diversity does have its own challenges as well. And i think we should be making sure that we utilize all available data to inform our research decisions. What more do you think that nih could be doing to encourage the use of safe and rigorous global Clinical Trials . Thank you for that question. I actually have personally conducted global Clinical Trials in the area of cancer, and that was done through the use of very careful protocols that delivered careful formats and monitored sites so we knew exactly what care was delivered as part of the trial that was testing a treatment. Those for things that really matter, that level of quality is very, very important. Ill just add parenthetically, there are other things we can do in Public Health globally that dont necessarily need to fit into the tight model. We should look at everything we can to help inform our work. Could not have said that any better myself. I think the dr. Bertagnollis eagerness and optimism is a reflection of her western roots which i have great appreciation for and i have other questions, but i will submit them on written record and thank once again the witness for being here and for your commitment to Public Service and turn it back to the chair. Thank you. Senator. Thank you, mr. Chairman and Ranking Member for this important hearing and conversation. Dr. Bertagnolli, its an honor to be with you today and i want to begin by recognizing and thanking you for your help in providing archived data from the National Cancer institute regarding radiation exposure from Nuclear Testing in western states. And especially as we have an opportunity to provide more support for these families across the country and very honored to have worked with senators hawley and senator with the inclusion of these in the authorization act. Thank you for that as well. Dr. Bertagnolli, the Institute Development award, idea with a small e, if you will, program plays a huge capacity in Biomedical Research across the entire state of new mexico. The networks of Biomedical Research located on the mexico State University campus provides Biomedical Research environment for more than 10 other institutions across my state. Despite the Program Targeting half of the country, ideas budget is 10 of the overall budget. If congress were to provide more funding specifically for idea, how would you as nih director expand the program . First of all, senator. Lujan, id be delighted. As you heard in this hearing i want to see nih research expand to encompass all of our country, not just a few advantaged locations and i would look forward to expanding that program, not only by partnering with the outstanding academic institutions, within the idea states, as they grow out their educational and Research Outreach programs, but also, for programs that we have that are National Infrastructures such as the national Clinical Trials network. And other infrastructure, that literally goes down into individual communities. So, it would be very welcomed and quickly applied into action. I appreciate that, and on the same note. Do you support increasing state participation across other major Research Programs beyond the current mechanisms such as those supporting Biomedical Research facilities, instrumenttation and training . Yes, i view this as one way we can engage more American People in the research that we conduct and it would be very positive. Youve 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 to exist to increase diversity among Research Staff that would have implications for diversity and research participants, the Clinical Research work force that itself is diverse is better able to prioritize, care for research. How will you ensure that nih reflect the people impacted by the studies conditions . Thank you, this is a priority. Its a priority, why . Because we know that as weve already alluded to, a diverse Research Staff like a diverse care staff, brings excellence, really brings Better Outcomes for the people that we serve. How are we doing this specifically . Targeting programs to identify very talented individuals who come from diverse backgrounds, giving them opportunities to 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. And mr. Chairman, i have some other questions ill submit into the record and ill yield back. Thank you very much. Senator cassidy, you wanted a second round . Yes, please. Dr. Bertagnolli, youd said that you maintained the Biden Administrations policy for allowing fetal tissue research, but that it should only be used as a last resort. How can you ensure that fetal tissues are only used as a last resort . Thank you, senator. You know, understanding the great sensitivity of many people and a passionate feelings of many people on the issue of fetal tissue research, i would want to be very respectful of that. Again, if confirmed as nih director, my job is to serve everyone, including the communities who care deeply about how that tissue are used. Absolutely, i would follow the laws of the land in every aspect and i would also follow within the laws of the land, the dictate is were trying to achieve maximal good for people. Were trying to cure major diseases. Thats our highest goal, but we need to do it with respect and also follow the law. Let me ask you, its a slippery slope, were doing it for an end and therefore the means are justified. The specific question how would you ensure that fetal tissue is only used as a last resort . Thank you, i would follow our 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. Okay. Now im going to ask you questions related to obesity. In my state, unfortunately is 50th or 49th in terms of obesity. So, im told that the amount of funding directly for obesity and by the way, we know it, but just for context, obesity is a major driver of Health Disparities. Disproportionally affecting the poor and those of color, but also, whites and it is a major driver of morbidity from heart disease, from cancer, from covid19, we know that. Im told that the funding at nih that specific for obesity is only about 1 roughly 1. 2 billion a year, 2. 5 of the budget. Now, again, but a major driver of Health Disparities and morbidity and all the things that you and i know of. So arguably, funding for obesity has 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 foundational translation and implementation for regional obesitity . Thank you senator. I will say from my current position from the National Cancer institute obesity, and rising obesity is one of the factors of cancer and to identify the eatology of this, how obesity drives cancer and how that 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 for which weve got to work across all of the institutes that can have a piece of owning this problem. And then the last thing ill say, again, stigma. Making sure that people who suffer from this condition are respectfully included as being part of the solution to the problem. I accept that. One suggestion, im told that nutrition, Obesity Research centers, a funding which is kind of stagnant and just to increase that funding would be a place to start. And again, if were talking about something which is driving cancer, heart disease, hip replacement, you name it, why not i use today tell my medical students, obesity is here and has a hydra head. It seems like we focus more on manifestations than the creature itself. If we address the creature itself, we address all of these. That seems to have been lost. If you could address that, that would be great. I would be really delighted to work with you on this. I agree that this is a very Serious Health problem that takes up multifacetted approach and agree its something that we need to work on and would love to work with you on. Thank you, ill yield. And i knew senator cassidy, if we waited long enough, there would be an issue we agree on and obesity is certainly an epidemic and impacting diabetes and a host of issues and this committee must and will deal with. Theres an issue that we didnt touch upon today and ive raised by deep concerns that there are many millions of americans who cannot afford the outrageous cost of prescription drugs in this country and that is something that the nih must deal with. But theres another issue that we didnt talk about, and that is that we look at the global situation, we look at developing countries and, you know, millions of people throughout the world who are struggling to feed their families. What we find is that many of the prescription drugs consumed are consumed in developed world. There are poor people around the world cannot afford the medicines they need, medicines, by the way, which may cost a few cents to produce, they dont get it and they die or they suffer. The sorry. All right. Thank you. Last may, President Biden announced that the u. S. Government would share some nih funded covid patents with the World Health Organization to expand access to low and middle Income Countries if confirmed would you build on this commitment and make sure that medicine nih dollars accessible in low and middle countries and shared with manufacturers in developing countries so they can produce the medicines their people need or the price neck 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 the 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, theyre not getting it to people for whom it might be life or death. Thats something that you would Pay Attention to . 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 ha our hearing is reminded the committee will have a markup next wednesday the 25th on thisay nominee. And a few others for any senators who wish to ask additional questions, questions for the record willfo be to be e tomorrow by 5 p. M. The committee stands adjourned. [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] cspan is your unfiltered view of government. We are funded by these Television Companies and more including comcast. Are you thinking this is just a Community Center . Its way more than that. Comcast is partnering with 1000 committed centers to create wifi enabled lift zones so students can get the tools they need to be ready for anythg. Comcast supports cspan is a Public Service ang with these other Television Providers giving you a frontrow seat to democracy. 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