Anthony Fauci Testimony Transcript on NIH Budget Amid Coronavirus Outbreak

Ms. DeLauro: (09:45) The subcommittee will come to order. Good morning all. Dr. Collins, welcome back to the Labor HHS Education Appropriations Subcommittee. Let me also welcome all of you five institute and center directors who are joining in this morning. Dr. Bianchi, Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. That's almost as long as the Subcommittee on Health Education, Human Services and Related Agencies here. So anyway, Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, Dr. Gary Gibbons, Director of the National Heart, Lung and Blood Institute, Dr. Ned Sharpless, Director of the National Cancer Institute, and Dr. Nora Volkow, Director of the National Institute on Drug Abuse. Again, welcome, welcome, welcome to all of you. Ms. DeLauro: (10:42) Actually, [inaudible 00:10:43] asked me this morning, he said, "Do you have the NIH coming?" I said, "Yes, indeed." He says, "And are you ultimately going to be able to get all the institute directors to come up?" And he said, "He will," and he said, "It is one of the most remarkable hearings that we have." And we thank you for the great work that you do and what a difference that you make in saving lives of the people of this great country. Ms. DeLauro: (11:07) At the start, let me just touch on a matter of the coronavirus. I want to just say a thank you to the director, to all of the institutes. I want to just say particularly thank you to you Dr. Fauci. And I want to say that our public health experts deserve our praise for what is the excellent work that you are doing on what is clearly a matter of national importance and national urgency as you know, in so many ways. Ms. DeLauro: (11:43) Today, we will be discussing the 2021 budget request for NIH, and I want to note that I intend to invite an additional panel of institute and center directors to testify in front of the subcommittee later this year, because I believe that we all learn a lot of from all of you. And, and we did that, that happened with us last September as well. Ms. DeLauro: (12:08) Before we get into the NIH's 2021 budget, let me just, if I can, bring you up to date. I think you know that the committee has been working hard to develop an emergency supplemental to be able to fund the response of this outbreak. There's still one or two issues that remain open, but with all speed and deliberation, the intent is that and the chairwoman can speak to that if she cares to. But we're looking at trying to move as quickly as we can between today and hopefully tomorrow, but before the end of this week to get this finalized and voted on. So the funding includes funding for the NIH. The funding will support research on diagnostics, therapeutics and vaccines for COVID-19 that will be critical to managing the outbreak and again to save lives. I also might want to note that NIAID is not starting at square one. Rather, the years of building the research on Coronaviruses and vaccine development. And I just want to say to the whole subcommittee, to my colleagues on both sides of the aisle, have invested, sustained investments in biomedical research that the committee has made in recent years. And I am very, very proud that the Congress has increased the NIH funding by $11.6 billion, 39% over the past five years. Last year alone, the Congress provided an additional $2.6 billion increase over fiscal year 2019 level for the NIH. And this was in a bipartisan, bicameral way that this was done, and we're very, very proud of that. I know certainly the ranking member is, and we work closely together on this issue. Ms. DeLauro: (14:17) I would just say to you that I think the president's budget would reverse this project. The budget proposes to cut NIH funding by $3.3 billion, 7.9%, below the 2020 level. This would result in NIH making nearly 1800 fewer new grants to researchers, a reduction of 16%. This subcommittee will not be pursuing these cuts. We intend to move forward with a continued increased investment in NIH to build off that progress that we have made in recent years and again, that will be on a bipartisan basis. I know that you know as I know anything about where we're going and what we're doing. Ms. DeLauro: (15:01) I am especially proud that the Congress provided $25 million for research on firearm violence prevention, including the 12 and a half million dollars to the NIH. I was glad to see that the NIH budget requests maintains the funding for research on flu, including on the development of a universal flu vaccine. However, I believe we need to continue to grow this research as we did in fiscal year 2020, and I look forward to hearing more about what NIAID will accomplish with these additional funds. Ms. DeLauro: (15:31) I was disappointed to see a $559 million cut to the National Cancer Institute at a time of unprecedented promise in cancer research that has led to more and more promising researchers seeking NCI research grants. I think cutting the funding for NCI sends the wrong message. In fact, with only a few exceptions, the proposed cuts to NIH would touch every institute, almost every field of research. Last year, in addition to new funding for several initiatives, we were able to provide a 3.3% increase to each NIH institute and center. We need to keep up that momentum and not reverse it. I believe my friend and my colleague ranking member, Tom Cole, will concur. Biomedical research is one of the most important investments that a country can make because it gives the gift of life, which we need to support and promise you that we will. Ms. DeLauro: (16:31) Thank you again for everything that you do and I look forward to our conversation today and let me turn this over to my good friend from Oklahoma, the ranking member of the Subcommittee, Congressman Tom Cole. Tom Cole: (16:43) I want to thank you. Thank you Madam chair and thank you all for being here. Before I get to my prepared remarks, I just want you guys to know how deeply how you span the bipartisan divide that we have here. I actually made a statement and it was tweeted out by Howard Dean last night, so I thought that was worthy of note. I very seldom get tweeted out by Governor Dean, so I was pretty proud of that. And the statement was, "If I'm buying real estate in New York, I'll listen to the president of the United States. If I'm asking about infectious diseases, I'm going to listen to Tony Fauci." Tom Cole: (17:19) So I think that sums up where we are as a committee, and I want to commend all of you and thank all of you for what you've been doing in the middle of a difficult national crisis, but more importantly, what you just do day in, day out, every single day and the amount of hope you give people around the world, certainly our fellow Americans. And I think you have been extraordinary custodians of the investment that this committee has made on a bipartisan basis for multiple years, I know intends to make again. If we can find any way to do it, we'll do it and I think we will find a way to do it. The current challenge that we have, frankly, is a reminder that you need to do these things and you need to do them on a regular basis. You can't just show up on game day and think you're going to be able to deal with something. You have to have made the commitments, the investments over a long period of time to have the infrastructure to do it. Tom Cole: (18:15) I'm very proud of this committee and our counterparts in the United States Senate because we've done that, and we've done it ... I'm proud of Congress for this quite frankly. This is no disrespect to anybody, but this committee has consistently the last five years gone beyond what any president of either party ask it to do. And it did that because Congress, when we actually doubled the NIH budget many years ago, that was actually also a congressional initiative, if you'll recall. I think Congress actually, because it's very close to the people, has a very keen sense of awareness of how much your fellow Americans value the endeavors that go on at the NIH. Tom Cole: (18:50) So I'll go to my formal remarks. After five years of sustained increases for the National Institute of Health, I'm pleased to welcome once again to this hearing room Director Francis Collins. You must get tired of hearing this, but once again, I want to commend you, Dr. Collins, on your long and distinguished career in federal service. You've left a legacy of excellence and it's really an honor to work with you. And I've said this often too, you got to be the best politician in a town of politicians to get appointed by Donald Trump and Barrack Obama. It doesn't happen very often, but again, I think it says something about the bipartisan nature of what you do and the national commitment there. Tom Cole: (19:27) I've made no secret of the fact that increasing funding for the NIH is one of the proudest bipartisan accomplishments of this subcommittee. A sustained steady commitment to increase NIH funding is critical to ensuring our nation's future is a leader in biomedical research and unlocking cures to so many of the diseases burdening our strained healthcare system. The hard work and innovation this funding fosters is part of the sustaining force of the United States economic growth. Leaders in the House and Senate, Democrats and Republicans, have unified behind these increases over the past five years, and I ardently hope this trend continues for years to come. Tom Cole: (20:06) While I appreciate and sympathize with the fiscal restraint expressed in the president's budget, I do not think the reduction proposed for NIH is in the best interest of the American people. To reduce the NIH funding at this juncture would erode the progress we've made, as the chairwoman mentioned, over the past five years, signal to the research community instability and quite possibly, delay by years or perhaps decades advances in modern medicine including curing diseases, finding better treatments for cancer and unlocking the power of precision medicine. Tom Cole: (20:37) I also want to caution against the budget request proposed changes to the negotiation for indirect costs or funds included as part of the grant to cover facilities and administration. This critical funding serves as a foundational element of research and I support the enacted bill language. I hope Madam chair, we continue that restraint and this is a false economy that our friends in some quarters have pointed out and it's one that will hurt research, not provide additional dollars. We simply need to protect the institutions that we've been investing in. Tom Cole: (21:16) This past year, we had the opportunity to sit down with a Nobel prize winner, Dr. Jim Allison. His work on immunotherapy for cancer treatment promises to chart a course for a new direction for treatment for our deadliest cancers. The noninvasive nature and rapid time between treatment and resuming normal daily life is nothing short of remarkable. Moreover, these treatments are coming to market faster than therapies of the past and could take a decade before standard health insurance reimbursement. New applications for research in this area are overwhelming available federal funding and it's something I hope we look at very carefully going forward. Tom Cole: (21:57) Companies have noticed the promise of such methods and are beginning to invest their own resources as well. 10 years from now, we may have thousands of cancer survivors that under today's treatment protocols would not have been helped. It's stories like this that remind me that support for the NIH has a real life impact on life and that every dollar investment is a direct down payment to a better future for millions of Americans and tens of millions of others around the world. Tom Cole: (22:23) I also want to highlight the progress we've made on Alzheimer's disease research. This deadly disease is creating an enormous strain on the healthcare system, families and the federal budget. It's a rising cause of death and impacting more and more Americans each year. Total spending on Alzheimer's will exceed $1 trillion by 2050 if it remains on its current trajectory. We must make progress. Frankly, fiscally there's no other option. I'm pleased to learn an international team of researchers, partly funded by the NIH, has made more progress in explaining the genetic component of Alzheimer's disease. Their analysis involving data from more than 35000 individuals with the late onset of Alzheimer's disease has identified variants and five new genes that put people at greater risk of the disease. In order to tackle the physical, emotional, and financial toll of this disease is having on families, we must have a better understanding of the underlying genetics. Tom Cole: (23:21) I do not want to take up additional time recognizing all the distinguished institute directors before us today Madam Chairman because quite frankly, like you, I would rather hear from them about the exciting research that they're all involved in. However, I do want to thank each of you and your colleagues and those institute and center leaders who are not with us for your passion, dedication, and hard work. I believe the work at the NIH has and will change the course of disease direction and treatment for many generations to come. I hope Congress continues to be a supportive partner in these efforts. Thank you Madam Chairman for holding this important hearing. Ms. DeLauro: (24:00) Thank you very much. It's now my pleasure to yield to the chairwoman of the Full Appropriations Committee and someone who's had just a major role in making sure that we respond in kind and with alacrity, Congresswoman Nita Lowey. Nita Lowey: (24:17) And I thank you Chair DeLauro and Ranking Member Cole for holding this hearing, and welcome once again our very distinguished guests. I don't know how you're awake, Dr. Fauci but- Ms. DeLauro: (24:30) [ inaudible 00:24:31]. Nita Lowey: (24:33) It's all those exercise routines. Thank you but thank you everyone because I know it is a team effort. Let me say at the outset, President Trump's disastrous budget is filled with deep cuts that tear at the fabric of our nation. Instead of building on the historic investments in last year's appropriation bills, the president doubled down on partisan talking points to propose investing $2 billion for the wall and cutting $3.3 billion from the National Institutes of Health really does expose the Trump administration priorities for what they are, political rhetoric over public health. Nita Lowey: (25:25) But as you know, this committee is on your team. And at a time with surging cases and costs associated with heart disease, cancer, Alzheimer's and related dementias, a vaping epidemic, and now the novel Coronavirus, this panel's commitment to NIH will remain as strong as ever. Nita Lowey: (25:54) I would be remiss not to mention that with my retirement, this will likely be my last NIH budget hearing. I'll have to come and be in the audience and when I think about it, we've come so far since I joined the subcommittee in 1993. I was a kid then, when NIH was funded at about $10.3 billion. We committed to doubling the NIH budget, then more than tripled it. Together with the great leadership of this subcommittee, in the first five years, we have increases of 11.6 billion for a total funding level of 41.7 billion. And frankly, every penny was worth it and we are so appreciative for all of you, for your talents, for your hard work, for your commitment. It's really been an honor for me to serve on this committee. Nita Lowey: (27:06) I do remember touring a lab with a young Doctor Francis Collins, who had a plan to map the human genome. I remember that first map. There was nothing in it, and the advances in combating breast cancer have revolutionized survivor rates as immunotherapy has given life to people who would have had a death sentence a decade ago. We know more about childhood development and the human brain, and we are witnessing amazing strides in precision medicine. And if you recall, we now even have some female lab rats. For those who weren't part of that humor at the time, we were convinced all the lab rats were male. So I'm delighted to know that you have female lab rats. Nita Lowey: (28:14) Your work has filled me and millions of Americans with hope. Never, in all of human history, has medicine had more to offer. And yet with all these great achievements, we have so much more to do. I recently came across my questions from an NIH hearing in 1999 when I asked why women are more likely than men to have Alzheimer's. We still don't have the answer. In fact, we don't have many answers to Alzheimer's. I was on a panel, Lord knows why they asked me to be on a panel, and it was about 35 of us sitting around a table with one person who knew what he was talking about, a scientist from Columbia. Everyone was kind of quiet. And I said, "Dr. Gibson from Columbia, so what are you recommending?" Nita Lowey: (29:21) For many people around that table, they were experts, people who've been working on this for years and years. He sat up and he said, "Diet and exercise." Dr Fauci knows that, right? We've had conversations about that actually, so many of you. But after all investments, that's really all we're offering most people when it comes to Alzheimer's. We still don't know the answer and we still don't have a method for early detection of certain cancers. We still don't know why treatments work for some patients but not others, and we still don't know why rates of autism are rising and why there are higher rates among boys than girls. By the way, if you have answers to any of these questions today, feel free to share them with us. This may be up to date, I thought as of this morning, but if you have some answers to these questions, we'd love to hear them. Nita Lowey: (30:37) So there's so much we need to achieve and I can think of no better people to do it than the people sitting in front of us today. You have saved lives. You have eased suffering. You are our super heroes. And with the polarization in our politics, if the American people could see how we come together to fund such important work, I was going to say they would be proud. They'd probably be shocked, but maybe we should invite more to really understand how bipartisan the NIH is and how bipartisan this committee is. And that is why we cannot let a partisan budget request stand in the way of saving lives. So I thank you all. It's a pleasure for us to welcome you once again. Madam Chair. Ms. DeLauro: (31:37) Thank you Dr. Collins. I'm going to turn to you for testimony and as you know, your full testimony will be entered into the record and [inaudible 00:31:47] five minutes of time for your testimony. Thank you. Francis Collins: (31:50) Well thank you and good morning Madam Chair DeLauro, Ranking Member Cole and especially Chairwoman Lowey. Did not realize you were going to make this announcement about 1993 to today. I think 1994 was the first time I appeared in front of this committee to defend the genome project. So thank you for that reflection. On behalf of the national- Speaker 1: (32:10) Dr. Collins, stop ignoring the MECFS crisis. Speaker 2: (32:13) [inaudible 00:32:13]. Speaker 1: (32:13) Over one million- Speaker 2: (32:14) [inaudible 00:32:15]- Speaker 1: (32:16) Are sick, disabled or bed bound. Ms. DeLauro: (32:17) Please- Speaker 3: (32:18) [inaudible 00:32:18] ill [inaudible 00:32:20]. Ms. DeLauro: (32:18) What is she saying? Speaker 1: (32:24) [crosstalk 00:32:24] on behalf of over a million sick Americans [crosstalk 00:32:26]. Ms. DeLauro: (32:43) Dr. Collins, please. Francis Collins: (32:45) I do want you to know that the condition, MECFS, chronic fatigue syndrome is of great concern to NIH and these are obviously [crosstalk 00:00:32:52]. Ms. DeLauro: (32:53) If you need time to mention that, please go ahead and do it okay? In the course of the proceedings this morning. Francis Collins: (33:01) Sure, just- Ms. DeLauro: (33:02) Please. Francis Collins: (33:02) I will- Ms. DeLauro: (33:03) Go ahead with your testimony. Francis Collins: (33:05) [crosstalk 00:33:05] on a later point. Okay. Let me continue. On behalf of the NIH, I want to thank you, the Subcommittee, for that $2.6 billion increase in last year's omnibus. The steady increases you have provided have brought new life to biomedical research and built a foundation for us to take on new and unexpected challenges, challenges like the one that's on everyone's mind right now, the global Coronavirus outbreak. Your investments have enabled NIH to be at the forefront of action against this serious health threat, and I'm quite sure you'll hear more about what we are doing from Dr. Fauci a bit later. Francis Collins: (33:42) In the meantime, I'd like to highlight a few of NIH has other recent achievements. My computer is talking to me, and maybe I could turn your attention to the screen. When Science Magazine announced it's short list of breakthroughs of 2019, three of them were supported by NIH. The first is the lifesaving progress we've made against Ebola virus disease, including the first effective therapies. Our second breakthrough according to Science, was the development of kids getting specially formulated foods to combat malnutrition, taking advantage of what we've learned about the microbiome. The third is development of a highly effective triple drug therapy for cystic fibrosis or CF. Francis Collins: (34:32) I'm among the legion of researchers who've been part of the long journey to develop targeted therapies for CF. Yeah, that's me on the left. That's 30- Nita Lowey: (34:41) Where's the guitar? Francis Collins: (34:43) It's off in the corner. On the left, 30 years ago, when I led the NIH funded team that co-discovered the gene for this devastating disease, while I was at the University of Michigan. Mutations in that gene lead to dysfunction of a protein that normally helps maintain the body's balance of salt and water, and without that, mucus builds up in the lungs, setting this- Francis Collins: (35:03) ... salt and water, and without that, mucus builds up in the lungs, setting the stage for potentially fatal respiratory infections. The new triple drug therapy kicks that protein back into shape. And does it work? Well, take the case of Robyn [Petrus 00:00:15], an Ohio woman with CF, who recently wrote to me. As these snapshots show, Robyn slept in a mist tent as a child, and her parents spent hours each day loosening the mucus that clogged her respiratory tract. Later she became so sick she had to give up her beloved teaching career. Francis Collins: (35:33) But just five weeks after starting triple therapy, Robyn's lung function improved dramatically. And she now lives the active life she'd always imagined. She's even set a new personal best, swimming a full mile in 60 minutes. I could not do that. She told me, "This medicine has revolutionized my entire physical and mental life." What a transformation. 30 years of research to get to this point and a wonderful example of basic science collaborations between public and private leading to this kind of breakthrough. So stories like Robyn's inspire researchers to keep searching for innovative ways to help folks with all kinds of diseases. Francis Collins: (36:14) Among the many exciting possibilities is a new generation of gene-based therapies. At past hearings, I've introduced you to just a few of those who've been helped by these therapies. People like Matteo with spinal muscular atrophy, Jenelle with sickle cell disease. And many of you had met cancer patients, like Emily, whose lives are saved by CAR T cell immunotherapy for cancer. But we need more breakthroughs. There are about 6,500 diseases for which we know the molecular basis. The pace of discovery has increased rapidly, yet we still have effective therapies for only about 500 of those. The latest development in gene-based treatments, the CRISPR gene-editing system, promises to boost that number. Francis Collins: (37:04) CRISPR provides a precise find and replace function for DNA, allowing cells to be reprogrammed to correct disease causing misspellings. Five years ago I never would have predicted this explosion of opportunities in gene therapy, but actualizing this potential poses real challenges. Today, it can take two years to produce the materials needed for clinical trials of gene-based therapies. A new one just announced this morning. We can rely on the private sector to support trials for more common diseases, but for ultra rare diseases which involve tens of millions of people, NIH must do more to de-risk projects if we hope to interest potential partners from the private sector. Francis Collins: (37:42) So to that end, the president's budget for FY-21 includes a $30 million initiative for an NIH led consortium to shepherd development of gene therapy targets for rare diseases, from concept to clinic, customizing processes for gene delivery, manufacturer regulatory review and testing. To conclude, these are dramatic times for NIH research. Today, I focused on gene-based therapies, but many other remarkable advances are on the horizon. Advances like developing vaccines for coronavirus and other infectious diseases. Using science to address our nation's opioid crisis and applying the power of immunotherapy to even more types of cancer. None of this would be possible without your support. Because of you, we at NIH are working hard to turn dreams of healing and health into reality for all. So, thank you. And my colleagues and I look forward to your questions. Ms. DeLauro: (38:36) Thank you very much [inaudible 00:38:37]. Thank you for the slides. It's always ... And the stories, because that makes it real in terms of how people's lives have been changed. I lost, growing up, two wonderful friends with cystic fibrosis and it's extraordinary how we can now save lives, and thinking about what we can do. Let me just ... Dr. Fauci, I recognize that you have been very, very generous with your time and providing the subcommittee with information about NIH's current and proposed activities related to COVID-19, including basic research, development of diagnostics, therapeutics and vaccine. Ms. DeLauro: (39:24) Just kind of a two part question. Would you give us a brief update on the latest developments in NIAID's work in this area? Because as I mentioned, NIH isn't starting from scratch with regard to the research on coronavirus or on emerging infectious diseases. If you can tell us about how prior investments in NIAID, that research have laid the groundwork for what we're able to do now with the coronavirus. Anthony Fauci: (39:54) Thank you very much for that question, Madam Chair. Yes. In fact, if you look at the fundamental basic research on molecular virology and the ability, which really comes from NIH itself and NIH-funded investigators, to be able to identify a pathogen and sequence extraordinarily rapidly to allow us to do the things that I'll mention in a moment. But this goes back to fundamental basic research on molecular biology, virology, genetics, et cetera. Remember, the first coronavirus that caused the problem globally was the SARS virus in 2002, which were 8,000 people and 775 deaths for a death rate of about nine to 10%. Anthony Fauci: (40:38) Several years later we had the MERS coronavirus, again, causing a problem in the Middle East. Now we have the third coronavirus. One of the things that we've been able to do and the NIH, as you know, does many things and we're studying very intensively the fundamental virology and pathogenesis of the disease, but the things that we're doing right now in the form of interventions are in the arena of vaccines and in therapeutics. It's really extraordinary that from the first time the sequence was made public by the Chinese, when they discovered what virus it was, literally within days we took that sequence off the database and inserted it into one of our vaccine platforms called the messenger RNA in the Vaccine Research Center at the NIH. Anthony Fauci: (41:29) And then what we did was do a step-wise approach, which is to first determine, is it immunogenic? Can you stick it in an animal and would it make an immune response? The answer is yes. I predicted that we would be about two to three months to go into phase one trials and I think we're going to beat that. I think we'll be in in probably about six weeks, which as a matter of fact will be the fastest that anyone ever has gone from the identification of a sequence into a phase one trial of any vaccine that's ever been done. That's the good news. Anthony Fauci: (42:04) The sobering news is that since vaccines are given to normal individuals, what is paramount is safety and whether or not it works. So we'll do a phase one trial, we'll do it in a number of our centers, including our center at the NIH. That will take about three to four months. And then if successful, which I believe it will be, there's no reason to believe it won't be safe, we'll go into what's called a phase two trial. The phase one trial is 45 individuals. Phase two trials are hundreds, if not a couple of thousand individuals. It would take, then, about a year to a year and a half to be fully confident that we would have a vaccine, that will be able to protect the American people. Anthony Fauci: (42:45) And so, although the good news is we did it fast, the bad news is that the reality of vaccinology means this is not going to be something we're going to have tomorrow. In contrast with therapy, if I might say, we have a number of therapies that was used in an animal model and in vitro. We don't know if they work, but we've already started a trial in the United States on a Gilead drug called remdesivir in both Washington state, which is having a problem as you know right now, as well as in the University of Nebraska where we have put the people who were expatriated, who were repatriated and brought back, a clinical trial will be done. Anthony Fauci: (43:22) And if in fact it's shown to be effective, maybe not perfectly effective, but at least somewhat effective in bringing down viral load. We imagine in the next several months, and it'll take that long to do the trial, that me might have an intervention. So going back from what you said all the way to the molecular virology decades ago to where we are right now, I think that's what we call the proof of the pudding of investment in biomedical research. Ms. DeLauro: (43:48) Thank you. Thank you very, very much. As your grandmother, my grandmother would have said, "Lemon and honey is going to help your voice a lot." Maybe a shot of bourbon, I don't know. But in any case, I have just about 13 seconds left. So I am just going to yield back my time and get around to my other question in second round. [inaudible 00:09:08]. Tom Cole: (44:08) In the spirit of bipartisanship, I want to assure you that shot of bourbon can help you, Madam Chair. I test it routinely and it works very well. Dr. Collins, last year when we were ... We all are always interested in stretching these dollars as far as we can and putting money behind research. But I think one of the smart things we did last year in a bipartisan and [inaudible 00:44:29] way was to set aside $225 million for infrastructure, frankly, and for facilities maintenance. And we know that does not meet your needs. And the idea, I think ... The hope would be, we'll see where our allocation is, what we can do. That would be something we could sustain on an annual basis for a number of years. So to let you catch up to where you need to go. So one, could you tell us sort of how that $225 million has been used? Two, what would you do if you had additional funds in the next year of comparable size? Francis Collins: (45:04) Congressman Cole, I really appreciate your raising this issue because it is critical to the effective functioning of this remarkable engine of discovery, the National Institutes of Health, and its intramural program. We have over the course of quite a few years been successively falling behind in terms of maintenance just because of the way the funding comes through. We're not allowed to spend money on buildings and facilities unless it's appropriately designated as such. And we now add up where we are. We are about $2.1 billion in the hole in terms of the kinds of funds that would really ideally be necessary to keep the place in the kind of circumstance that you would like to see. And we've had a number of really major problems in our clinical center, which have caused quite a lot of difficulties in terms of being able to take care of patients. Francis Collins: (45:49) I can if you like, if it comes up here, show you a particular example of just some of the things that you can see have happened in the course of just the last few months in terms of floods. We've had to close down big parts of our clinic at times, so we have a big backlog of needs. The National Academy of Sciences was asked by the Congress to look at this issue and agreed that we need urgent attention to this matter. We also believe we need in order for the clinical center to be fully effective to replace our current operating rooms which are at risk of having leaking in the ceiling in the middle of an operation. And that's obviously something you would never want to see happen. And so, we have on the books already to go a surgery radiology wing. The cost of which though is about $500 million. Francis Collins: (46:34) What you have done in terms of increasing the support for this has helped us hugely and it will help us both with the backlog of maintenance that we need to pay attention to, but also to try to build up sufficient amount of funds to start that new wing. And it will be greatly much appreciated if that can be also sustained in FY-21. You saw the President's budget actually did call this out as a special need by increasing that number for BNF to $300 million. So I know this is not sexy in the same way as we're going to cure cancer, or we're going to find a new answer for autism, but without the infrastructure, we can't take care of patients in the way that they are counting us to do. Tom Cole: (47:11) Gosh, the fact that you showed up with slides might suggest to people we coordinated this in some way. That would never happen- Francis Collins: (47:18) Never want to miss the chance to [crosstalk 00:47:18]- Tom Cole: (47:19) Never happen. Dr. Gibbons, heart disease and stroke are seven times higher in American Indians and Alaska Natives, then among their White counterparts [inaudible 00:47:30] and certainly my staff, which has a high concentration of Native Americans. Actually, has the highest death rate from heart disease in the country. So could you tell us what the NIH is doing to address these health disparities and describe some of the progress you've made in recent years? Gary Gibbons: (47:44) Yes. Thank you for that question. That addresses, really, an important concern we have and an important health disparity. As you pointed out, we particularly have concerns about rural populations and we recognize that and started a new cohort study. Our institute is known for the Framingham Heart Study over 70 years ago, of taking communities and starting to dive deep and understand what are the driving factors. We've now taken this to a program that's actually called Rural that focuses in on Kentucky, Alabama, and other areas with large rural populations. Gary Gibbons: (48:26) That's where we're seeing actually cardiovascular disease going in the wrong direction, as it is with certain populations of American Indians and rural Americans. Similarly, we're engaged in studies, like what we call decipher. It's where we're taking community-based efforts to address how can we engage communities in the process of creating healthier communities. Recognizing that often there are social, and behavioral, and cultural factors. And so, that involves a community engagement strategy. In fact, Dr. [Fretz 00:49:04] is a Native American who's leading an effort. She's now the principal investigator of our strong heart study, which is based in Oklahoma, the Dakotas and Arizona. Gary Gibbons: (49:15) And she's engaged in a project to promote healthier lifestyles, particularly in American-Indian communities. In fact, taking them into a more traditional diet of fruits and vegetables, whole grains that we know can help prevent heart disease. So this is a very top of mind and high priority. Tom Cole: (49:35) Thank you very much. Thank you, Madam Chair. Ms. DeLauro: (49:38) Congresswoman Lowey. Nita Lowey: (49:41) Thank you. I think I ask this question every time, Dr. Collins. Are we learning anything about the development of Alzheimer's? How far are we from even a temporary ... I won't say a cure, but let me ask it. How far are we away from a cure or real prevention? Alzheimer's. Francis Collins: (50:06) I wish I had a crisp answer to that, but I would say progress in the last few years has been really impressively moving forward. We have identified pathways that are involved in Alzheimer's disease, going well beyond the amyloid and the tau hypothesis, which has been so dominant. Genetic studies have revealed now about a hundred different places in the DNA that provide a risk for this and it tells you that there are things going on we didn't appreciate, such as that the immune system is involved here in some way and lipids are involved in a way that goes beyond what we knew about before. And the cells in the brain that are sort of the supporting cells, the so-called microglia are at least as important as the neurons, which have always gotten all the attention. Francis Collins: (50:51) All of that has led to in a partnership with industry, the Accelerating Medicines Partnership, the identification in just the last year of 52 new drug targets which are of great interest to academics and drug companies in which will lead us down a whole bunch of new directions in terms of therapeutics. But I have to say the amyloid hypothesis is still very much on many people's minds. Even though we've had all of these failed trials and we don't understand why they failed. Please keep in mind Biogen is still taking the position that their most recent trial, when they reanalyzed the data, did look as if it provided benefit to people who got the highest dose of this antibody against amyloid for the longest period of time. Francis Collins: (51:34) And they've gone back to FDA and FDA has been willing to look at the data again, and watch this space closely. If FDA decides there's something there, we might actually finally be in a place where we have a signal of some benefit. And then of course, the whole game changes. There's a huge difference between having everything fail and having something work a little bit, because then you can build on that and we're all watching that closely. So it's really all hands on deck. NIH is running now over 200 clinical trials, not just about drugs but also about preventive interventions. Francis Collins: (52:07) The Sprint Mind study, which Gary Gibbons could tell you more about, has definitely shown that reducing blood pressure seems to be a good way to prevent the onset of dementia in susceptible individuals. Vascular contributions are really important here. We're pretty sure that physical exercise helps. We're pretty sure that cognitive exercises are also of benefit. I wish I was able to say that with absolute certainty. So we are making progress, but let's make no mistake, this is a really hard problem. Nita Lowey: (52:37) Okay. I'll ask you next year by ... I'll write you a letter next year, because I can't ask [crosstalk 00:52:43]. Can I come and see [inaudible 00:52:46]. Okay. Dr. Sharpless, another one of my favorite issues, because it's been so disappointing. Are there any advances that have been made in early detection and treatment for kidney cancer? Ned Sharpless : (53:03) Yes. We think the incidents in fact of kidney cancer has gone up modestly related to improved detection, so it's finding smaller lesions earlier. This provides some challenges because when you start taking very small cancers, we always worry about this issue of over-diagnosis and over-treatment and detecting really dangerous cancers, as opposed from the more indolent type. But I think that kidney cancer is an important human cancer where we have made some progress, but there's more to be made. Ned Sharpless : (53:34) It is not one of our most outstanding successes in the cancer world. Immunotherapy has some role for these patients. In terms of early detection, we are still considering a number of approaches, including I think perhaps the most promising right now in addition to imaging is the ability to detect nucleic acid in the blood. So blood tests for something like kidney cancer or other related cancers. So we have a number of approaches, but stay tuned. It's still early. Nita Lowey: (54:00) Well, my time is running out. So I'm sure Dr. Gibbons and Dr. Volkow, you all know about the rising rates of eCigarettes, particularly among young people, which is just startling. In 26 seconds ... Maybe I should have ... Okay. If you want to make a a quick statement and then we can go back and get into it. Because I am really concerned about the incredible rates. Nora Volkow: (54:28) And I think we should be concerned. In 2018, we saw a doubling in one year of the number of kids that were vaping nicotine. And in 2019, we saw a doubling of the number of kids that were vaping THC. So the concern is of course that these kids are becoming addicted both to THC and nicotine and we may lose the big battle that we've won over combustible tobacco with all of the adverse consequences. So yes, we should be very concerned. Nita Lowey: (54:58) So we'll save it for the next round. I don't want to overstay my welcome. Thank you. Ms. DeLauro: (55:04) Congressman Harris. Andy Harris: (55:06) Thank you very much, Madam Chair. Dr. Fauci. I'm surprised you have a voice left at all. You appear to have been everywhere. You must have twins or something, you're everywhere. Let me ask you a question about ... Because you used the word the sequence for the coronavirus 19. And that's the one I take it that the Chinese have shared for that sequence? My understanding is also that they've been unwilling to share other samples of the virus. That that was just one place in time and that it would be useful to know, to see other samples. Is that true? I mean, from a scientific point of view, is that something that would be useful? Anthony Fauci: (55:48) It would be very useful, but we're mitigating that problem, Dr. Harris, because we now have, unfortunately, [crosstalk 00:55:55] enough cases in our own. Yeah. Andy Harris: (55:58) And that's of concern to me, that the Chinese did not share that because I don't know. Look, in this instance, days or weeks might be very important and I'm afraid that we might've lost days or weeks because of the Chinese unwillingness to share those early case samples. Now, the fatality rate is of course controversial because WHO just announced that they think it's 3.4%. You've been, I think, quoted in the New England Journal of Medicine a few days ago saying, "Well, it's probably less than Anthony Fauci: (56:23) Two. Andy Harris: (56:23) ... 1%." Anthony Fauci: (56:24) No. Andy Harris: (56:25) Where do you think it's going to end up? Because we don't know the denominator right now. Anthony Fauci: (56:29) You said it, sir. If you look at the cases that have come to the attention of the medical authorities in China and you just do the math, the math is about 2%. If you look at certain age groups, certain risk groups, the fatality is much higher. But as a group, it's going to depend completely on what the factor of asymptomatic cases are. So if you have asymptomatic cases that are a lot, it's going to come down. What we're hearing right now on a recent call from the WHO this morning is that there aren't as many asymptomatic cases as we think, which made them elevate, I think, what their mortality is. You know as well as anybody that the mortality for seasonal flu is 0.1%. So even if it goes down to 1%, it's still 10 times more fatal. Andy Harris: (57:27) When will we know with our own data do you think? Anthony Fauci: (57:31) We will know with our own ... I'm torn, Dr. Harris, because if we get enough data to have a big end, it's going to be bad news for us. But we're learning more and more. The thing that's encouraging is that as part of the WHO umbrella team that went to China, finally, after a long period of time, there were two USA individuals on there. One from the CDC and one from the National Institutes of Health. He has come back. He is now in self-isolation in his home, but he's going to be giving us a report pretty soon about that. And I think from him ... You know him, [Cliff Lane 00:00:58:12]. he's the individual who's my deputy and I think we're going to get the information you need. Andy Harris: (58:17) Well, thank you. Dr. Collins, a couple of questions about data and information sharing. In your budget justification, it said the NIH is in the process of updating its data sharing policy. I'm curious if you have any information on the amount of data that's indeed shared by NIH grantees and whether you believe mandatory sharing of data should be a requirement of all those receiving grant funding. And a related question, the administration has suggested that if someone receives federal funding, the published research should be available free upon publication, not a one year waiting period, but free upon publication. So could you comment on those two, what I'd call just kind of transparency issues with regarding federal funding. Francis Collins: (58:59) Those are very much on our mind, Dr. Harrison. Certainly in terms of having our grantees share the data that they've generated with public funds. We feel very strongly that's part of their responsibility and certainly the data sharing policies that we have been putting together make that increasingly clear. There are some legal limitations on are actually making that a mandate, but we can certainly put in terms of a term and condition of the award that that's the expectation and we can monitor that to see if in fact it is happening. With regard to publications, we also believe that if the public is paid for science, the science ought to be accessible to people who are interested in looking at it. Francis Collins: (59:38) As you know, this is a controversial topic because some of the journals would find this to be an existential moment for them if everything was free immediately. We are working in that direction. We have for a few projects, like the cancer moonshot, like the heal initiative, require that everything that comes out of those projects has to be accessible at the very moment that it's published without any charge or any firewall. And that is a signal of where we want to go eventually. But this is a complicated negotiation. Andy Harris: (01:00:06) That's right, but is it your feeling that it would be an existential threat or that the journals could probably find a way around it? Francis Collins: (01:00:14) I think all the journals are looking at options that they might try to adopt as alternatives to those that require complicated and expensive journal subscriptions. Andy Harris: (01:00:23) Thank you very much. I yield back. Ms. DeLauro: (01:00:25) Congresswoman Lee. Barbara Lee: (01:00:27) Thank you, Madam chair. Thank you ranking member for this hearing. Thank you, Dr. Collins. Thank you for your team. It's always good to see you and I associate myself with the remarks of everyone who has talked about the importance of continuing with our bipartisan work. Because really, you are in the business of life-saving and life-affirming and just thank you for everything that you're doing. Of course you know, I have focused a lot on the National Institute of Minority Health and Health Disparities. And unfortunately, I see this 30 million cut above what it was. It requests 305 and the enacted level is 336, so it is a $30 million cut. Now we know there are many disparities as it relates to communities of color. Barbara Lee: (01:01:10) When you look at the disproportionate rates of lupus, and thank you very much for following up with our request on lupus in terms of an action plan. Higher rates of Alzheimer's among older African-Americans, sickle-cell disease in trait. And then, in many ways I feel like I've received a medical education from all of you because so many of my family members, friends and community suffer from multiple sclerosis, COPD, lupus, sickle-cell, HIV and AIDS, A1C tests, diabetes and sickle-cell trait relationships. So I personally, like most members, have gotten into the weeds on a lot of these diseases and we have put in budget requests and language and I want to thank you for being responsive and for bringing forth the plans that we have asked for. Barbara Lee: (01:01:57) So in terms of these cuts, I'm curious with regard to what the $326 million cut to the National Heart, Lung and Blood Institute would do in terms of our COPD action plan. Also, the cut again in the National Institute for Minority Health and Disparities, the $30 million cut and over and over. And I can talk about these cuts as it relates to some of these diseases; multiple sclerosis, the brain initiative. I believe there's a cut of about 40 million. So can you just kind of tell me how you're going to deal with this if these cuts in fact go through? Barbara Lee: (01:02:38) And then my second question is, and I want to thank you for the report as it relates to the growing absence of Black men in medicine and science, and we're working very closely now with partners in this. And I wanted to ask you with regard to the common fund, how can we support more comprehensive work? Because this is outrageous in terms of what's happening to Black men in medicine and in the sciences. And how we can help fund the National Academy of Sciences and based on their round table, work that they want to continue. And can we look to the common fund? Unfortunately, I see a cut of under 96 million less. And so, can we ... No, I'm sorry, 42.6 million less than 2020. So can we kind of talk about how we're going to address these issues within this budget? Francis Collins: (01:03:32) There are so many important questions there. Let me just try because I know time is short. With regard to what NIH does when we encounter a circumstance of really significant resource constraints, I think all of the people at the table would agree with me that we try to still identify what our priorities are and try to protect those as much as we can. We look around to see if there things that could be slowed down without quite as much of a serious impact. But it is painful to try to do that. And every one of the areas you talked about, we would have to struggle with exactly that kind of priority setting. I'm really glad you raised the issue about our workforce and the need for more representation from underrepresented groups. Francis Collins: (01:04:10) Our workforce does not look like our country and it should. I want to mention, and this is something that you brought up in terms of the common fund, the program called the Build Initiative, which is a way in which we are making it possible for people from traditionally underrepresented groups to have a real scientific experience as undergraduates, which is how you actually capture the attention and the imagination and the passion of young people. And that program, which has now been going on for four or five years, is actually looking very promising. And none of these we would do would be done without really evidence-based analysis. Francis Collins: (01:04:45) We're not going to support things that don't work. We also have supported a national mentoring network for people who may not be like me, a White male who would naturally have a network that they could depend on. That has also turned out to be quite positive. You are right, that may be an area we're particularly worried about as African-American men. We have a recent initiative we're discussing with the NCAA about how to interest athletes in science and provide them with scientific opportunities, like summer internships in a research lab so that that will be seen as a more attractive possible career path with mentors and role models that they can learn from. So we're all over this. Barbara Lee: (01:05:21) Do we have new partners and new ideas coming out of the National Academy? [inaudible 01:05:29] would it be possible to work with your team to present ... Excuse me. New strategies, new ideas and see if we can develop some broader partnerships that would actually enhance what you're doing? Francis Collins: (01:05:41) Absolutely. We're closely aligned with the National Academy on this topic and they've been very much partners and we would like to build on that and do even more. Barbara Lee: (01:05:49) Okay. Thank you very much. We'll followup. Ms. DeLauro: (01:05:50) [inaudible 01:05:53]. John Moolenaar: (01:05:53) Thank you, Madam Chair, and thank you all for being here. Good to see you all again. And Dr. Collins, appreciate your many years of service. And I wondered if you, and also Dr. Sharpless, could talk briefly about the President's childhood cancer initiative? That's something that I know we funded and just wondered if you could give us an update on that. Francis Collins: (01:06:14) [crosstalk 01:06:14] Dr. Sharpless is ideally suited for that. Ned Sharpless : (01:06:16) I'd be happy to take that. Childhood cancer is an area where we've seen significant progress over the last few decades, but we still have a ways to go. There are still clearly too many kids dying of cancer in the United States and there's still, even the kids we're able to cure are often left with lifelong survivorship challenges because of significant surgery and radiation therapy and chemotherapy. So it's an area where we need clear progress and the administration announced that this is a top priority of theirs to make progress in childhood cancer. And the President announced this initiative at the State of the Union more than a year ago. Ned Sharpless : (01:06:45) And now Congress has appropriated the funds and we're tremendously grateful for that important devotion of effort and resources to this topic. So it's underway. We have had sort of convened a lot of the thought leaders in the community about how to make progress most expeditiously in childhood cancer. We have charged a working group to come up with ideas and we're well underway. The focus here is on sort of how to use data better for childhood cancer and sort of radical data aggregation. I suspect, for example, we'd be able to create a registry that has data on every child with cancer in the United States and in terms of outcome and followup, that'll be a significant improvement over what we have now. So it's a very exciting initiative that's really getting started. John Moolenaar: (01:07:30) Okay, thank you. And Dr. Volkow, I wonder, in the past you've discussed efforts to develop non-opioid alternatives to help manage both acute and chronic pain. I wonder if you could give us an update on the status of that research and some of the innovative approaches that might be coming down the pipeline. Nora Volkow: (01:07:50) Yeah, thanks for that question. And indeed, the general support from Congress that gave us $500 million to our base to actually address interventions and science that can solve the opiate crisis has enabled us to advance enormously our investments on understanding pain, transition from acute and chronic, but also to develop new therapeutics and to determine what implementation we can currently do to help patients that are suffering from chronic pain. As a result of that, there are several projects that have emerged, including the creation of a network that will enable ... Two networks. Nora Volkow: (01:08:27) One of them will enable the development of new molecules and testing and the other one will enable that testing in patients with pain of the interventions. And this is done within industry, with partnerships with industry so that we can help accelerate, but also with academic centers. And [inaudible 00:33:50], this has been an incredibly challenging area to develop treatments that are as effective for pain, but safe. And that's why it's so incredibly relevant that we create the partnerships with pharmaceutical industry. And I think, I mean Francis has taken a lead on this and I don't know if there's anything else, Francis, that you think worth mentioning. Francis Collins: (01:09:11) No, I think you've said it well. I would like to emphasize this is another all hands on deck circumstance where 20 of the NIH institutes are ganging together to work on this initiative we call HEAL, which stands for Helping End Addiction Longterm. And for that we need to have non-addictive but effective pain medicines and we are working quite quickly in that space, recognizing it's a really hard problem. John Moolenaar: (01:09:33) Thank you. Dr. Fauci, we've been talking a little bit about the coronavirus and I wonder if you could comment on some of the partnering that you, NIAID has been doing with [Berta 01:09:46] on the development of medical countermeasures for these threats in general, biological and pandemic threats? Anthony Fauci: (01:09:54) Yes, thank you very much for that question. It transcends coronavirus certainly, because the NIH has fundamental- Anthony Fauci: (01:10:02) -because the NIH's fundamental mandate and work is in fundamental basic research and its translation into translational research, which is then translated into a product for intervention. And if you look at the things that are now out from a number of diseases, from HIV to Zika and now to corona, it's essentially a process where we do the initial fundamental research, bring it to its early stage of development, usually into Phase I, and hand it over to [BADA 01:10:34] . Anthony Fauci: (01:10:34) What BADA does... Get their resources and partner predominantly with either biotech companies or larger pharmaceutical companies to make a product, based almost invariably... In fact, if you look at some of the things that have now come out with products, almost every single one of them, with few exceptions, has NIH fingerprints on them from the very beginning. So I think it's really a nice marriage and part of the continuum from the fundamental research to the product and it's worked very well. Speaker 4: (01:11:06) Thank you very much. Thank you, Madam Chair. I yield back. Rosa L. DeLauro: (01:11:09) Congressman Pocan. Mark Pocan: (01:11:10) Thank you very much, Madam Chair, and thank you all for being here. Dr. Collins, thanks for having all your colleagues here. I think the single easiest thing to say is, and it's totally a tribute to all of your work, when you see the bipartisanship, when this comes forward... When our ranking member was the chair of the committee, or Ms. DeLauro, we as Congress increased funding to NIH, and I think it just shows how much we all value everything you do. So thank you. Mark Pocan: (01:11:35) And I just want to say, thank you so much for updating the statistic. I'll mention it because I think it's good for everyone to know. We used to have how many drugs were approved, I think in a six year period, that had NIH support, and it was every single drug. You just did a 10 year period. We looked back, going through '19. Of the 356 drugs approved by the FDA, each and every single one had support from the NIH, and that's our tax dollars. So thank you for updating that number. I think it's something, as we talk about drug pricing and other issues, that's very, very helpful. Mark Pocan: (01:12:06) I feel like I would be doing legislative malpractice, however, if I didn't talk about the coronavirus, especially with Dr. Fauci here. I want you to know I follow you very closely. I have enormous respect for what you say. I've been following Scott Gottlieb. I had and have enormous respect for him. I've been following the World Health Organization, trying to get various sources on this. I have to be critical in one area, and I'd love you to help maybe talk me off a ledge on this, but I don't know if you can... Is the lack of how we're handling testing right now. The fact that all of a sudden CDC has dropped keeping track of how many people we test. Mark Pocan: (01:12:40) We had someone this morning talk to us who was part of the Ebola response. Their comment, and I'm going to paraphrase, is "When you don't even know what you don't know, that's not a great place to be in trying to figure out how to deal with things." And the fact that if we start not keeping track of this, the amount of tests... And who we're testing. We should be much more aggressive, I believe, in my opinion. We should be in the hospitals. Anyone who's got a pneumonia that we can't necessarily identify we should be testing, because otherwise medical professionals need to know... Mark Pocan: (01:13:07) I just feel like this is one area we've... You gave me great response on where we are on finding something to help, whether it be treatments or otherwise, a vaccine... I feel like this is one where we're dropping the ball. And I do want to get to another question, but let me ask you, on this particular... Help talk me off the ledge. I'm nervous that we're not keeping track of who we're actually testing and the fact that we're not more aggressively testing. Anthony Fauci: (01:13:32) Well, I'm not going to try and talk you off the ledge because you're making a good point. So... Mark Pocan: (01:13:38) Okay. All right. Anthony Fauci: (01:13:39) Push him off. No, it's less the keeping the track of the tests, sir, than it is making the tests available and withdrawing the restrictions on who can be tested. So let me explain, because this is really an important issue. Mark Pocan: (01:13:58) I just want to leave a minute for the other question. Anthony Fauci: (01:14:00) Yeah. Okay. So the issue is, the tests from the CDC were for public health components, stayed in public health groups. They'd have to give it to them; the test comes back to the CDC. That started off with some technical problems which delayed that going out. The major issue that I find and many of my colleagues find problematic is that if you're looking for people in the community who don't have a recognized link to a test, we call it community transmission, then you've got to withdraw the restrictions. That in order to get a test, you have to have a link to something, it's almost inherently contradictory. Those have been lifted. The FDA has taken the constraints off, and now we finally have companies that are going to be making many, many more tests. Mark Pocan: (01:14:53) But should we be proactive in testing, especially in hospitals in places like that, rather than waiting for people to come and be tested? Anthony Fauci: (01:15:00) Yes. Mark Pocan: (01:15:01) Okay. Because I just feel like that's one of the components [crosstalk 01:15:05]. Anthony Fauci: (01:15:04) The answer is yes. Mark Pocan: (01:15:04) Okay. Thank you. Anthony Fauci: (01:15:06) And I feel strongly about that. Mark Pocan: (01:15:08) Thank you. I love when I get a one-word answer. Maybe you could meet with Secretary DeVos and explain to her yes or no questions. Second area, I'm worried about supply chain. I just read China Rx, because Rosa told me, and now I've got Mike Gallagher, one of my colleagues on the Republican side, from Wisconsin, going to read the book next. I am concerned about the fact that, as we've had the conversation previously about this, the number of either drugs that are made, active ingredients that are made, I would add medical devices that are made in places like China... And I don't know, do we really know what that supply chain is, with the various companies? We did a letter this morning, Pramila Jayapal and I, to the top 20 or so prescription drug companies, and are asking this very question. But do we keep track of this anywhere, to know how many of the drugs are made in places like China, and where we could be for potential shortages in a case like this? Anthony Fauci: (01:16:01) I believe that the FDA does, and your concern is one that we've been talking about as part of pandemic preparedness for years. When we put together the plan back in 2005, we said, one of the real problems is supply chain. I was somewhat, I would say, impressed-slash-shocked, that something like 90% of the fundamental ingredients that go into many of the drugs, not the actual drug itself, comes from China. So that is a real problem. And I don't have any answer to you. It's not anything that we do, but it's something that impacts us. Mark Pocan: (01:16:41) Can I ask one really, really quick followup? Should we be tracking active ingredients and medical devices as well? Supply chains? Anthony Fauci: (01:16:48) Yeah, I would imagine, yes. But again, that's out of our purview. Mark Pocan: (01:16:52) Okay. Thank you. Anthony Fauci: (01:16:52) Thank you. Rosa L. DeLauro: (01:16:52) We will do a briefing with Rosemary Gibson, China Rx, so that we can talk about that. Congresswoman Herrera Beutler. Jaime Herrera Beutler: (01:17:03) Thank you, Madam Chairman. And I'm glad Mr. Pocan asked about this. This is one... Yesterday when I was at the White House I asked Vice President Pence about the supply chain issue. And I know in the last number of months we've heard "we're fine, we're fine, we're fine, we're fine, we're fine," for weeks, and then this last week we started to hear, "Well, there's some concerns." I think February 27th was the first time that a prescription manufacturer noted that there's a supply chain issue with regard to the coronavirus. And we've already seen shortages, for unknown reasons, of things like immunosuppressive drugs. And this is an area that I'm very focused on, seeing what the solutions can be in the short term. Because people say, "Go get three weeks of your prescription." Well, if your prescription is being rationed, you can't do that. Jaime Herrera Beutler: (01:17:57) What types of solutions can we... So there's now, and the coming year that we're going to be dealing with maintenance and treatment of this virus. What should we be doing? What can you see? And then obviously there's the big picture. You talked about needing to fix the supply chain overall for preparedness. Could you speak to that? Anthony Fauci: (01:18:17) The supply chain problem is, as you know very well, a longterm problem that has been brought to our attention multiple times. And then when you have something like this, you realize you have a supply chain problem which you cannot fix immediately, and there's no real easy fix for it. I don't have an answer for you. But maybe this will be a lesson as we go forward, that as I've said to this committee many times, this isn't the first nor the last emerging microbe that we are going to be confronted with. And one of the issues that's vulnerable when you have an emerging infection is getting cut off from things that we depend on from other nations. So, I'm sorry, I can't tell you what to do tomorrow or next month, but maybe we could talk about the future and how we might turn the knob a little bit. Jaime Herrera Beutler: (01:19:11) I'm interested in that. I want to hear about the future and how we can change the big picture. I do think there are some immediate solutions that I'm going to be asking the administration to be considering, and the different task forces, to make it easier for people to access their prescriptions. Maybe it's even accessing a brand that's available over a generic that's not available, and how can we help make that cost-effective for patients and hold them harmless? That's an area that I'm looking at for the immediate short term, because people need to have access. Period. Jaime Herrera Beutler: (01:19:42) The other thing I wanted to ask about is... And I don't know if you can speak to this, but your professional... So being from Washington State, and my district's on the coast, I'm in between Seattle and Lake Oswego, obviously people at home are very attuned to what's happening. The state has requested... And there's been a lot of coordination, been on the phone with all sorts of... The governor is talking to the vice president, talking to the task force, talking to our senator. Everybody's mobilizing. And I am very proud of our public health response. I'm grateful for the CDC and even FDA folks who were on the plane immediately. So we are moving forward. Jaime Herrera Beutler: (01:20:17) One of the things that was asked, and it's kind of around the strategic national stockpile, which is not necessarily under your jurisdiction, but perhaps you could speak to... We've made a request for personal protective equipment. I think we're only at about half of that has been let to us as a state. And then also, with it, what's your opinion about expanding CDC testing criteria? Because I agree, I actually think... So, the state can only test a certain amount of folks. We need it in the commercial labs, available for people to go in and test. Would you support expanding that criteria so we could get more people access? Your thoughts? Anthony Fauci: (01:20:52) Yeah, I would support... Expanding criteria means withdrawing restrictions. That's the point. Jaime Herrera Beutler: (01:20:59) I just want to hear it another way. Anthony Fauci: (01:21:00) Yeah. Okay. Jaime Herrera Beutler: (01:21:01) I think we can't say it enough. Anthony Fauci: (01:21:02) Yeah, right. And I feel very strongly about that. Washington has a very good public health group. Jaime Herrera Beutler: (01:21:10) Mm-hmm (affirmative). We do. Anthony Fauci: (01:21:11) They have put together a test that they've done. They've been able to do it. They need help. They need support. I was on the phone late into the night last night with my colleagues from Washington, and we really do need to act aggressively there. Jaime Herrera Beutler: (01:21:27) When you say help and support... Give me specifics. Anthony Fauci: (01:21:29) Oh, we need... For example, they are doing contact tracing on the nursing home outbreak. Now if they find out that it's community out there, they're going to have to do contact tracing on that. They're stretching their resources, and that's an issue. Jaime Herrera Beutler: (01:21:46) So backfill support, obviously, for them. Anthony Fauci: (01:21:47) They need some help. Jaime Herrera Beutler: (01:21:47) And they need bodies. Anthony Fauci: (01:21:48) And I think... In fact, I'm certain. Not I think, I'm certain, the CDC is, right now, as we speak, helping them. Jaime Herrera Beutler: (01:21:57) That's my understanding, but it is an evolving situation. Anthony Fauci: (01:21:59) I was on the phone with both of them last night, so that's the reason why. Jaime Herrera Beutler: (01:22:02) We appreciate that. Thank you, Madam Chair. Rosa L. DeLauro: (01:22:05) Thank you. On the supply chain issue, I would hope, on a bipartisan basis, that we could take a look, which is not the subject of this committee, but... Advanced manufacturing and what we can do in the long term on manufacturing those ingredients here rather than in China. And I think that's well worth our time and effort to take a look at. Congresswoman Frankel. Lois Frankel: (01:22:29) Thank you very much for being here. All right, so I just have to ask you some supermarket questions. So people think... When I go to the supermarket, people think that members of Congress should know everything. All right? So these are very simple, but... So, one of the questions I get is, if the coronavirus is just a cold, symptoms... Well, that's what we hear on the news. Diana Bianchi: (01:22:55) No. Flu. Lois Frankel: (01:22:56) Okay, more like the flu. Okay. So it's not just... I guess the question I have is, how long does it last and what makes it so serious? Anthony Fauci: (01:23:10) It isn't a common cold. The confusion is that about 10 to 30% of the common colds that you and I and everyone else get during a season happen to be a coronavirus, but a certain subset of coronaviruses can cause extremely serious disease. They did it with SARS, they did it with MERS, and now they're doing it here with the novel coronavirus. Anthony Fauci: (01:23:36) The reason it's serious is that... A question that was asked by Dr. Harris is that the mortality of this is multiple times what seasonal flu is. So seasonal flu spreads widely, the mortality is 0.1%. Right now, in China, the mortality for this particular infection is, the latest report, was 3-4%. It might be a little bit less. It isn't a cold. It's very interesting that most of the common colds have upper respiratory infections. This virus, not to get too technical... The component of the virus that binds to a receptor in the body to allow it to infect? Those receptors are rich in the lung. That's the problem. It binds to it. So a person can present no sneezing, no sinusitis, fever, shortness of breath. You do a chest x-ray and you have pulmonary infiltrates. That's not the common cold. Lois Frankel: (01:24:42) Okay. Well, thank you for...Now I'll have a better answer for people. Next question, if you're able to comment on this. In terms of your research, is there anything that you think the FDA can do to speed up your research? I see a shaking of the head by Dr. Collins. Francis Collins: (01:25:07) You're referring coronavirus specifically? Lois Frankel: (01:25:08) Or any drug that you've been researching. Francis Collins: (01:25:12) So, we work very closely with the FDA. We actually have a joint leadership council- Lois Frankel: (01:25:17) Okay, but maybe there's a better question. Is there anything that we can do to speed up the FDA? Yeah. Jaime Herrera Beutler: (01:25:22) Well, Tony, maybe you should say, specifically with coronavirus. Because FDA has been all hands on deck in that space, and has been very recently pretty actively enhancing the ability to do laboratory tests. Anthony Fauci: (01:25:34) I don't think there's anything that you could do to speed up the FDA. Quite frankly, they may need more resources to do the kinds of things they're doing- Rosa L. DeLauro: (01:25:44) [inaudible 01:25:45]. Anthony Fauci: (01:25:45) -but we have... That's right, Madam Chair. But we have very good relationships with them. They have been very, very cooperative and collaborative with us in trying to get these countermeasures out as quickly as possible, without cutting corners that would impact safety and our ability to evaluate efficacy. Lois Frankel: (01:26:10) What about a- Francis Collins: (01:26:10) That'd be... The former acting commissioner of the FDA might want to answer this question as well- Anthony Fauci: (01:26:15) There he is. Francis Collins: (01:26:15) -since he's now the head of the Cancer Institute. So yeah. What could the Congress do to help the FDA there, Ned? Ned Sharpless : (01:26:21) Yes, that's an interesting question. I'm here as the NCI director today. I don't really want to speak on behalf of the FDA, a different federal agency, but I think a challenge like this is really trying for the Food and Drug Administration, because it's so sudden and the machinery's built to be deliberative. I think, probably, the Device Center's decision about making these LDTs, the lab developed tests, more widely available and releasing those restrictions is a really important development. I think the academic labs will be able to bring these tests up to speed very quickly. I think there are definitely going to need more funding. I think they have some significant hiring challenges at the FDA that I worked on a lot. 21st Century Cures gave them a new hiring authority that was much appreciated, and I suspect they'll be using robustly, but they're really great people and I'm sure they're up to the task. Lois Frankel: (01:27:07) I think I'm running out of time, so one more question, on Alzheimer's. Is the private industry doing any research? Because I've always heard that, because it's so expensive, that they really are cutting back on that. Francis Collins: (01:27:22) They are, but it's not all companies. Again, I have the privilege of serving as the co-chair of the executive committee of what's called the Accelerating Medicines Partnership, which is focused on Alzheimer's as well as rheumatoid arthritis, lupus, and diabetes. And there's five companies there that are invested in this in a big way, and they have been willing to put their funds as well as ours together into a partnership where all the results are open-access. But it has been concerning that a number of other companies have ceased working on Alzheimer's Disease because of so many clinical trial failures. We need them to come back. I mentioned earlier, we have more than 50 new drug targets. We trying to encourage them to get interested again. Lois Frankel: (01:27:59) Okay. Thank you, I yield back. Rosa L. DeLauro: (01:28:02) Congresswoman Bustos. Cheri Bustos: (01:28:05) Thank you, Madam Chair. Well, first of all, thank you for answering so many of the questions that we have around coronavirus, but I'm going to actually switch topics. Is that okay? Cheri Bustos: (01:28:18) I'm from Illinois. The congressional district I serve is 14 counties. Goes up to the Wisconsin state line, Mississippi River's on the western part of my district, and then it goes into central Illinois. 11 of the 14 counties are rural, and then we have the population centers of what we call the Quad Cities, Peoria, and Rockford. So each of these counties and communities face the unfortunate circumstances that can lead to negative health outcomes, probably like almost every congressional district in the country. And as you know, these are called social determinants of health. I'm just going to give you a few examples. Cheri Bustos: (01:28:57) In Peoria, Illinois, we've got a problem with food deserts. I heard a story from a person in my district, takes them 16 bus stops to be able to access fresh fruit and vegetables. 16 bus stops. And then in Rockford, Illinois, Congresswoman Lauren Underwood just came to my district. She's the co-chair of the Black Maternal Health task force. And so we brought her in so we could bring health professionals together and find out, why do we have... In the State of Illinois, black women are six times more likely to die as a result of pregnancy-related conditions than white women. So it's something that, again, social determinants of health. How do we get to this? We have a hospital in my district that took them seven years to hire a primary care physician. Seven years. And then we've just closed, within the last year or two, the obstetric services out of Pekin, Illinois and Galesburg, Illinois. Cheri Bustos: (01:30:04) So those are some of the examples that we're facing. So along with Congressman Cole, we introduced the Social Determinants Accelerator Act. I'm very proud that we've gotten that out there. But here's what I'd like to ask you. And maybe, Dr. Collins, you can start, but we'd love to hear from the rest of you on this. Cheri Bustos: (01:30:23) The National Institute on Minority Health and Health Disparities has a strong focus on social determinants of health, but each of your institutes obviously has skin in the game on this. So I'm wondering if you can talk about how you're working together to address this, what I can take away from this. Love the powerhouse that we have sitting in front of us, and that's what I'd like you to focus on for the couple minutes that we have here. Francis Collins: (01:30:46) And it's a wonderful topic. In fact, every one of the NIH institutes, as you say, has skin in the game in various ways, and I could give you many examples. Because of the time, maybe I'll first ask Dr. Bianchi to say what we're doing in terms of this very thorny and difficult and important issue of maternal mortality, which is particularly a problem of health disparities. Cheri Bustos: (01:31:06) Thank you, Doctor. Diana Bianchi: (01:31:07) Thank you. NIH really shares your concern. The problem that we have is, although maternal mortality is rising, it is still a relatively rare event, so it's very difficult to study it. There are only about 700 women. That's too many, but it's hard to study 700 a year. We're focusing on the so-called " near misses" in addition. There are 50,000 more women who are near misses, and these women can help us to identify differences in survival. Why do these women survive, whereas there are others who do not? We also really need to understand, why is there a difference in African American women, as you mentioned, but also American Indian women as well as Alaska Native women, who all have higher risks of mortality, as well as all women over age 40. Diana Bianchi: (01:31:59) It's also important to recognize that maternal death doesn't just encompass pregnancy, labor, and delivery, but it encompasses the full year after delivery. And so we need to connect up obstetrics with internal medicine. Pregnancy puts a stress on a woman's body, as you know. It unmasks comorbid conditions such as diabetes, depression, and heart disease. So it's really an opportunity to intervene. Diana Bianchi: (01:32:28) Dr. Collins has put up this slide because we are now developing a trans-NIH initiative that's going to be known as the IMPROVE. This is the first time you've heard about this. It's "Implementing a Maternal Health and Pregnancy Outcomes Vision for Everyone." It has two components. One side, on the right, is the foundational biology part, which is really aimed at determining predictive biomarkers as well as novel technology. And on the left there's a social and biobehavioral aim. It's very important to connect the communities, not only to hear from them what they need, but then to be able to implement some of these changes. Francis Collins: (01:33:11) Everybody could tell you more about... And I'm sorry, because of the time I can't call on the other folks at the table, but we'd love to talk to you more about this. This is a very high priority for us. Cheri Bustos: (01:33:18) Okay, we'll set aside some time where we can talk outside of this hearing, but thank you very much. I appreciate your perspective on that. I yield back. Rosa L. DeLauro: (01:33:28) Congresswoman Clark. Katherine Clark: (01:33:31) I yield to Congresswoman- Rosa L. DeLauro: (01:33:34) She wants to yield to you. Go for it. Bonnie Watson Coleman: (01:33:38) Can you take that 33 seconds off my time, then? Rosa L. DeLauro: (01:33:43) Go for it. Bonnie Watson Coleman: (01:33:44) Good morning, everyone. Thank you for being here, and I'm so sorry that I missed a lot of the testimony. I think that you do important work, and I thank you for the service that you provide. Dr. Fauci, you said that you support proactive testing. True, right? Anthony Fauci: (01:34:00) Yes. Bonnie Watson Coleman: (01:34:01) So what does that mean? Why are we not doing it, and what does it mean, and who would be tested, and under what circumstances? Anthony Fauci: (01:34:12) We're beginning to do it now. It was not implemented earlier, and- Bonnie Watson Coleman: (01:34:18) What does that mean, though? Does it mean- Anthony Fauci: (01:34:19) Proactive testing means to... When you have community spread, where you do not have a known index case... So let me give you an example of what non-proactive is, and then it'll be easy to show what proactive is. So you bring in someone, as we did when we flew many of our diplomats and others from Wuhan, we brought them back to the United States. And the thing you needed to do was to test their obvious contact, like their wives or their husbands or what have you, and you wind up seeing that they're infected or not. Proactive means I don't know what's in the community, so I'm going to go to a bunch of emergency rooms, and when people present with symptoms that look like they might be coronavirus, even though they have no connection with anybody who has coronavirus, they didn't travel anywhere, and test them to see if they're infected. Bonnie Watson Coleman: (01:35:17) That's even in communities that have absolutely no knowledge of having any in there? Anthony Fauci: (01:35:21) Absolutely. Absolutely. Bonnie Watson Coleman: (01:35:22) So if I go to the emergency room in New Jersey, where there's no confirmed cases or anything, but I've got some symptoms, flu-like symptoms, right? They would test and make sure that it's not the coronavirus? Anthony Fauci: (01:35:39) There aren't enough resources to do it every single emergency room and every single center. So what the CDC has done, they've started by taking six sentinel cities and now they're expanding that to many more cities, essentially doing sentinel surveillance in different places. And that will give us a good idea, or at least a partially good idea, of what's under the radar screen that we're missing. Bonnie Watson Coleman: (01:36:09) So are these cities clustered only near, like, the state of Washington? Are these cities all over the country? Anthony Fauci: (01:36:17) No, no. The cities are Washington, Los Angeles, San Francisco, Honolulu, New York, and Chicago. And there will be more. Bonnie Watson Coleman: (01:36:27) My understanding is that the CDC is managing diagnostic tests sent to state public health labs, while FDA's managing tests at private labs. How does it get determined who does what? Anthony Fauci: (01:36:46) It's not a question of managing, it's a question of... The CDC's fundamental mandate is to develop the test and provide it for public health purposes to individual state, local public health authorities. The issue with the FDA came in when the FDA can give permission for a medical center... You pick it, University of Washington in Seattle, Cornell in New York City... To develop their own test, or to partner with a biotech or diagnostic production one, and do their own test on their own without needing the very intensive quality control that the FDA generally gives to a test. So that gives much more flexibility to have many, many, many more centers do their own tests. Bonnie Watson Coleman: (01:37:51) Okay. My husband had pneumonia in December and he's still coughing. I'm like, I want to send him. I want to send him to have him checked out. I'm very interested in research into the health disparities among minorities and non-minorities and minority children, and what's happening with the suicide rates, how it seems to be growing exponentially or disparately in the African American community, and I'm wondering... The budget, as proposed, what is the impact on the Institute that would do that kind of research and be able to support those kinds of services? Francis Collins: (01:38:43) So as we mentioned earlier, when NIH is faced with resource constraints, we try to identify what are the most high priority issues and try to protect those, even if it means that we have to cut back in other places. I totally agree with you. The question of health disparities, and especially something as heartbreaking as suicide, has to be a very high priority. And the National Institute of Mental Health, who's not represented at this table, has a big investment in that space, and particularly trying to understand, are there ways of identifying who's at risk and making an intervention before it's too late? And we're getting closer to that, and even using things like machine learning, taking advantage of what happens... Because everybody's carrying around a cell phone, there are indicators, in terms of people's reduced social interactions, that they are perhaps in a depressed state that you would not have otherwise known. A lot of that research now going on, and it's very appropriate to focus particularly on the health disparity part of it. Bonnie Watson Coleman: (01:39:39) May I make note that we did... I'm sorry, is that my 33 seconds? I yield back. I have other questions regarding this issue. Thank you. Katherine Clark: (01:39:55) Thank you so much, Madam Chairwoman, and thank you all, this incredibly esteemed panel. Dr. Fauci, I am hearing a lot from hospitals in my state in Massachusetts who are feeling under-resourced and unprepared for the coronavirus. Can you tell us a little bit about, as we are anticipating moving from containment to mitigation, how we are going to help with the hospitals around the country? Katherine Clark: (01:40:24) Uh-oh. Ned Sharpless : (01:40:30) Was that a response? Anthony Fauci: (01:40:31) Yeah, that was a... Anthony Fauci: (01:40:34) So when you say "we," you're talking about the United States government. So, I mean, I can't- Katherine Clark: (01:40:38) NIH and CDC. Anthony Fauci: (01:40:39) Well, the NIH is not going to be able to do anything there, except make as quickly as possible the results of the research we do to be able to be deployable in places like Massachusetts. The CDC works very closely with state and local health authorities, and that's one of the reasons why I think you're going to see... And I don't know what it's going to be, is that there are going to be resources that are going to have to be forthcoming to go. And I understand there's a supplemental package being gone through, and I want to address that. But that's one of the ways to answer the question, is that the states, Massachusetts including, are going to need some help to be able to implement the kinds of things that I think are going to be needed. Katherine Clark: (01:41:26) Looking at Massachusetts and this entire health crisis, one of the things I'm glad about is that Massachusetts has a very high number of insured people. That does not hold true across the country, and I am concerned about how our health insurance policy plays out in something like this. Can you tell, for me, where you see the gaps, and what's most immediately obvious to you about what we can do to redress it? Anthony Fauci: (01:41:59) That's a very good question, and because of that, most recently... It must have been the last couple days, they all seem to mesh into one these days, but a couple of days, that the director of the CMS has now been made a member of the president's task force. So that person is there. Those questions came up. Exactly the question you're asking came up at the task force meeting last evening, and that is going to be addressed. I don't know what the answer to it is, because that's not my area. But it clearly came up, just like you said, that some states, some territories, some regions have good insurance, good care, and others don't. So how are we going to get the tests equitably distributed? Not based on whether somebody can pay for them or not. Katherine Clark: (01:42:55) Yeah. It pulls in our paid family leave policies, all these different things, and we don't expect the CDC to take on that whole policy agenda, but they're so inter-tied, and I hope that the task force will also look at immigrant communities. If we cannot get immigrants to fill out a census because of fear, how are we going to get them to access healthcare for their children and themselves? Anthony Fauci: (01:43:23) Again, a very good question, because that also came up at the task force. And from what I'm hearing, that's not going to be an impediment. Katherine Clark: (01:43:30) Excellent. We will wait and see. Dr. Volkow, good to see you. I was also very concerned that the Trump administration had proposed transferring $5 million from substance use and mental health services, nearly 63 from NIH, to fight the coronavirus. I don't think we make trade-offs between public health emergencies. But I wonder if you can tell me... What progress has been made and what steps is NIDA taking to work on the youth-focused interventions and recovery support services? Nora Volkow: (01:44:10) Well, again, one of the things that has helped us enormously has been the $500 million that came to address the opiate crisis, because one of the projects that has been prioritized is prevention interventions. And when you address prevention interventions to help to avoid kids start taking drugs, you don't do it specifically for opiates. You do it in a general sense. And this is also important because we're seeing now that the opioid crisis is shifting not just from opioids to getting into psychostimulants. So it's not like we're going to have to address prevention for one drug. We need to address the question, what is making us vulnerable as a country? And youth are the most vulnerable of all of them. So we have several initiatives that are going to be expanded to address how, for example, we can bring prevention to rural communities- Nora Volkow: (01:45:03) To address how to, for example, we can bring prevention to rural communities that are at very, very high risk for drugs to the criminal justice setting. How do we intervene in schools? And another project that we have been able to hopefully lounge, as you know, we've done a 10-year followup for children from nine to 10 upward to understand what are the factors in the brain that makes you vulnerable to drugs. But how does the environment influence them? We want to start in infancy to look forward. So these are just some of the examples that we're targeting to try to develop knowledge and implementation methods to prevent youth from taking drugs. Katherine Clark: (01:45:39) Great. I'm out of time. I'd love to follow up with you in another way on medically assisted therapy sport treatment for younger people as well. Thank you. Ms. DeLauro: (01:45:53) Thank you. What I'm going to try to do is to ask three or four questions and get quick answers to them. And let me just start with this. Dr. Bianca, endometriosis, a disease impacts one in 10 women, leading cause of hysterectomy. Can you describe NICHD's research related to endometriosis. Tell us what your top priorities for the research would be, if provided with additional resources. And I'm asking this question... And where is my colleague, Congresswoman Finkenauer, who has a very a serious interest in this area, and thank you for being here Congresswoman Finkenauer. So hold onto that. Dr. Collins, we gave you a 12 and a half million dollars for gun violence prevention research. I want to have you tell us what do you expect to do with that. Also with the Office of Research on Women's Health, NIH budget has grown by 39%, Office of Research on Women's Health has increased only 8%. Ms. DeLauro: (01:46:58) Anyway, they have a critical role in doing what we need to do across all of the institutes. How would additional resources for the Office of Research on Women's Health enable the office to better advance and coordinate women's health research. And Dr. Gibbons, cardiovascular disease and women. Stroke, heart disease, leading cause of death for women in the United States. What research is NHLBI supporting to improve diagnosis and treatment of women with heart disease. Dr. Bianchi. Diana Bianchi: (01:47:32) Thank you, Madam chair. As you said, one in 10 women have endometriosis. These are women of reproductive age. It's associated with chronic pain, has enormous economic impacts because women do not go to work. It's a leading cause of infertility, and it's also associated with an increased incidence of cancer. NICHD has a gynecologic and health disease branch where we are funding research on the diagnosis, prevention and treatment of endometriosis. We've made it one of our 10 aspirational goals in our strategic plan, and I'm very proud of the fact that NICHD's research. We were talking about drugs that were developed as a result of NIH support the drug Orilissa, which is the newest drug to treat pain in women with endometriosis. Came out of an NICHD SBIR grant. Thank you. Ms. DeLauro: (01:48:27) And I would just say this to Congresswoman Finkenauer that you ought to be in touch with Dr. Bianchi to get all the information that you need to move forward. Francis Collins: (01:48:38) Very quickly to preserve time for- Ms. DeLauro: (01:48:39) On violence prevention research. Francis Collins: (01:48:41) ...firearms. We have invested in firearms research all along, and having this additional funds from the Congress in the current fiscal year is something that we welcome. We are invested in a full set of threat research to Americans' wellbeing and we will continue to do so and are certainly committed to executing any funding directives from the Congress. We have already written up various funding opportunity announcements, are waiting momentarily for them to be cleared. We will look at such things as the role of video games of trying to keep firearms out of the hands of adolescents. Such things as the violence interrupter schemes that are carried out in some cities. Do they actually work? We need data here, and we're the data people so you can count on us. Francis Collins: (01:49:24) You asked about ORWH, the Office of Research on Women's Health. A very important part of what we do... Janine Clayton, who's the director of that, is a wonderful catalyst, but let me emphasize that while the funding of ORWH is modest, it's about $43 million. The overall funding for women's health research is about $4.4 billion, so it's reflective of the way in which this in fact involves all of the institutes. Ms. DeLauro: (01:49:48) I'm very, very concerned about the amount of funding to the Office of Women's Health Research. I understand it's being done, it's cross-cutting, but this is something that many, many years ago we identified as something critically important, and I want to make sure they're getting the resources that they need and let me just say.... Go ahead, Dr. Gibbons on NHLBI. Gary Gibbons: (01:50:11) Well, maybe I'll take off on that point. A key part of the initiative for NHLBI to address women's health and cardiovascular disease is actually to take more of a focus in their reproductive years. And to do that, we recognize that a leading cause of maternal morbidity and mortality actually relates to cardiovascular disease, particularly women over the age of 30 in their reproductive and childbearing years. So we have a number of initiatives that are getting that. So for example, pregnancy is often a stress test for the cardiovascular system, [per party 00:01:50:48] coronaropathy is a major cause of maternal morbidity and mortality. Gary Gibbons: (01:50:54) So we're really striking up an initiative to better understand what are the drivers and biomarkers and actually genetic factors that may be predisposing to that. Similarly, we recognize that women who have adverse pregnancy outcomes often have a longterm trajectory of increased cardiovascular risk. So we have the newborn moms-to-be health heart study that's following up over time and recognizing that there may be interventions we can do to change to hold trajectory of those women. Ms. DeLauro: (01:51:31) And it really... These things play in together. They're not in isolation. They're not in silos. Gary Gibbons: (01:51:36) That's correct. Ms. DeLauro: (01:51:36) And they work together on this. Let me [inaudible 01:53:33] Tom Cole: (01:51:40) Thank you very much Madam chair. And when I think about the appropriations, it's too easy sometimes to get caught up in a what-are-we-doing-this-year kind of mentality. The rally is the way this process works. It's everything is cumulative and increments variations. And so under that philosophy we've adopted over the last five years a cumulative, an incremental increase for NIH funding. And so Dr. Collins, I want to ask you two of my favorite questions because you always take me an interesting direction. First is, what of the things we've been able to do that we would not have been able to do had we not made these kind of consistent investments, and looking forward, what are the things that you think we might be able to do if we will continue down the path that we've been on, that is sustained inflation price increases for the NIH over the next five years. Francis Collins: (01:52:40) Love being asked these questions. Thank you, Mr. Cole. The way in which this five years of steady increases influence things is perhaps most dramatically visible in what we've been able to do for early stage investigators. Back in 2015, we funded 600 of those grants in one year and that was not nearly enough and people were getting pretty concerned whether they had a career path. This past year we funded over 1300 of those, more than doubled this investment in the next generation of talent. And that morale has just dramatically changed. I'll be in Alabama tomorrow and Friday meeting with investigators, and I can tell you they're going to be really excited about science because now the environment makes it possible for them to take risks. Francis Collins: (01:53:23) Similarly, we've been able to increase the number of just overall grants and the number of principal investigators. We've enriched the breadth and width of the entire workforce that we depend on. In terms of specific things. We've been able to put forward projects that are truly bold, moving our understanding of life to single cells, to single cell biology effort. Being able to go after things like the influenza vaccine at an even higher rate, the universal flu vaccine than we would have otherwise, and develop platforms like what we're now using for coronavirus. We couldn't have done that if we hadn't had this support. Francis Collins: (01:53:57) Initiating this dramatically bold program called All of Us, that aims to enroll one million Americans in a longterm prospective study of health, and that is going to be a platform for so many other things that we'll want to learn about, and that takes resources. The brain initiative really trying to figure out what's between your ears does what it does. Again, now spending half a billion dollars on that. And it is remarkable what kind of technologies have been invented and what impact that will have on brain diseases, cancer, immunotherapy, making great advances, but we would not have been able to do as quickly without your help. And the whole focus on opioids and finding alternatives to opioids through The Heal initiative. Those are just a few of the things that we would not been able to do had it not been for your strong support and seeing this predictable upward trajectory. Francis Collins: (01:54:44) What we could do going forward? Well, gosh, the sky's kind of the limit here. I mentioned in my opening statement about gene therapy that we are at this cusp where we can begin to take what's now been done, curing sickle cell disease with gene therapy. Let's start curing a lot of other of these conditions, as well. We can see the path forward to do that. Francis Collins: (01:55:03) New opportunities in terms of artificial intelligence, machine learning applied. We're going to have a big investment there coming in the next year or two because we can see ways this could play out in multiple different applications. A new focus maybe on nutrition. We're talking seriously about that. It's an area that we know is critical for health, and yet the science hasn't necessarily quite jelled around the new opportunities. It's time to do that, and again, that's going to take resources. Francis Collins: (01:55:31) And all the things we've talked about in terms of health disparities, ending HIV in the US, dealing with the new difficulties with methamphetamine and cocaine, not just about opioids. Those are all in our minds as visionary things we can accomplish with this kind of path being continued. So I really loved the question. And everybody at the table would have their own answers, but I guess I kind of give you a bunch of mine. Tom Cole: (01:55:53) Mr. Sharpless, on cancer, what would your answer be? Ned Sharpless : (01:55:56) Yeah. I think you mentioned Jim Alison earlier, Nobel Laureate who won the Nobel Prize for figuring out how to use the immune system to cure cancer. I think what's maybe not known about Jim's stories that he started out in a small institution at Texas. That's where his first paradigm changing research was done. It was not a glamor institution. It was before he went to Berkeley. It was before he went with MD Anderson. It was before he went. Ned Sharpless : (01:56:14) Sloan Kettering. And I think that I'm obsessed with the fear that they're these great scientists with terrific ideas who are working out. They are sending us their grants. We've had an explosion of grants submissions, 50% increase ever since 2013, and then we're not able to get to their great idea cause our pay lines just aren't high enough. So with the generous appropriation the Congress has been giving us, we've been trying to get those numbers up so that we can get to those really innovative cutting edge science that make a difference for patients like Dr. Allison's work. Tom Cole: (01:56:41) I just would say, Madam Chairman, I hope we look at this this way. We ought to be thinking about this because as Dr. Collins said, every person here could give us a different answer if we could tell them with some sort of... We're going to stay on the track that we've been on, and we want you to think that way and present those kinds of possibilities. I think this committee has done that, and frankly, done a good job at it. Ms. DeLauro: (01:57:05) Congresswoman Lowey. Nita Lowey: (01:57:06) Thank you very much. I want to take this opportunity again to thank you all for your extraordinary work. I came back because I wanted to get back to the whole issue of these cigarettes with Dr. Gibbons and Dr. Volkov. With all the information out there, it's not penetrating the kids. And the rising rate of e-cigarettes among young people, as you know, is startling. When I look at the numbers, 64 people died, nearly 3000 were hospitalized last year with vaping, respiratory-related illnesses. Nita Lowey: (01:57:45) Now as I understand it, many but not all of these cases were attributed to vitamin E acetate, longterm impacts of vaping, but concern is growing that there could be longterm health consequences of heart disease, stroke, cancer. In a couple of minutes we have... I'd like to hear from both of you. What can we do about it? And if you have any ideas it would be welcomed. I just see these numbers increasing on college campuses exponentially. Nora Volkow: (01:58:21) Yeah. One of the things that we don't necessarily recognize is that these vaping devices are very high technology for delivering drugs in ways that make them very, very rewarding and addictive, so you can actually deliver huge quantities of nicotine in much higher concentration that would you normally do with combustible tobacco. As a result of that, what we're observing is in the past where a kid will take several months to escalate. Now we're seeing this escalate in a couple of weeks. And that is also associated with toxicity but much higher risk of addiction. And that's what we are now facing. Nora Volkow: (01:58:57) And the numbers speak for themselves. One of the main reasons which was not even recorded in the past, but teenagers are saying that they are vaping nicotine is because they say they are hooked to it. So they have done that transition very, very rapidly. And I think that the message is that it's urgent that we do interventions to prevent it. We need to stop it because otherwise we will go into tobacco smoking again for the one hand, but also all of the points that you are saying that I will let my colleague Dr. Gibbons address, we don't really know what are the consequences of delivering these vaping into your lungs, as well as other organs. So what I will rely on... Gary Gibbons: (01:59:37) So you clearly raised an important area of concern. Just last summer... Obviously you're describing the cases of e-cigarette and vaping-associated lung injury that really started to explode as sort of a new epidemic and mysterious illness. We didn't know why people were presenting with hospitalization, shortness of breath and other symptoms until we got these history of vaping. This was an area where close collaboration quite frankly between NIH, FDA and CDC and responses public health threat was pretty immediate and collaborative, in which almost literally within weeks we were convening subject matter experts from around the country, and, again, leveraging prior investments this committee has made because we were able to leverage centers of excellence in tobacco regulatory science, bring and convene people who've already been studying e-cigarettes together and say, well, what can we do? What's going on about this new vaping epidemic related to lung injury? Gary Gibbons: (02:00:41) That mobilized a research agenda. And so again, within weeks we put out a notice to engage our research community, to start studying what is driving this EVALI. And the CDC with its case definition and surveillance apparatus was able to start to make these links to THC and substances that might be combined with THC that might be driving it. By December, we clearly had a sense, at least as you pointed out, that vitamin E acetate from samples from the lungs may be a key associated element of this phenomenon. And again, related to the researcher community that we establish, investigators were already beginning to study and get the causal link between vitamin E acetate and study it in animal models. Gary Gibbons: (02:01:31) And in fact, just the last couple of weeks, it was published in the New England Journal related to an NHLBI-funded investigators in Roswell Park that indeed just giving the vitamin E acetate through a vaping device, at least in this mouse model, was able to recapitulate a lot of the lesions seen in patients with EVALI. So literally within eight months we've been able to close the loop from a mysterious disease, involving a collaborative effort between NIH, CDC, and FDA to address that public health threat. And with that awareness, we're starting to see the cases come down. But as Dr. Volkov mentioned, we still don't know the longterm effects. In fact, we've now funded a cohort to follow the trace of all those patients with EVALI. And we've recognized that EVALI is probably just the tip of the iceberg. What's happening to subclinical injury to the lung of the longterm of these young people? That's still an unknown. Nita Lowey: (02:02:26) Well, my time is up, but I would just hope that we could work together. I think it's pretty conclusive this just isn't good for kids, adults or anybody. Gary Gibbons: (02:02:36) Absolutely. Nita Lowey: (02:02:37) But what are we doing about it? The kids don't believe it. And working with CDC perhaps, we wrote... I'm with you. I would ban it completely. But I'd like to follow up with you because it seems to me the science is conclusive and what are we going to do to get these kids to understand, cut it out. Thank you very much. Ms. DeLauro: (02:02:57) Congressman Harris. Andy Harris: (02:02:58) Thank you very much and thank you all for being here. It makes me nostalgic for the days I used to do research, how exciting it is, especially when we have discoveries. Dr. Collins, just briefly... A group of us are going to send a letter to the president asking him to look again at human embryonic STEM cell research, which we understand still continues at the pace of about a quarter of a billion dollars a year at the NIH. As you know, that's not... the future really is pluripotency, of inducing pluripotency of regular cells into STEM cell states. And the idea that we're continuing to destroy human embryos in funding it or funding the destruction basically through the NIH, I think is a mistake. Because human embryos are in fact the youngest humans. Andy Harris: (02:03:50) And I think many believed correctly, the human life should never be used as a mere means for achieving the benefit of another human being. And that's not the purpose of human life. So I would hope that if the president responds positively to our letter, that we come up with a way to phase out that, to just phase out the use of a quarter of $1 billion on something that really has yielded no direct clinical benefit yet. And I understand the basic science reasons to pursue it. But these are humans, these are the youngest humans. We should move away from that as soon as a practical. Andy Harris: (02:04:28) Dr. Volkov, it's good to see you again. You probably know what I'm going to ask about. It's been a year and I want you to update us on the marijuana research that's done, looking at its effect on the brain because as more states attempt to move to recreational use of marijuana. Fortunately in the last omnibus bill, an attempt was turned back to make recreational marijuana industry much more profitable and widespread through removing banking restrictions. I mean, those restrictions still in place. So it buys us some time to actually educate the American public. I think about how dangerous it can be. Andy Harris: (02:05:03) So, if you could just talk about that. And just as an aside, as I do believe our colleagues in Energy and Commerce are going to move finally in medical marijuana research bill that makes it easier to do research and to truly discover what is merely a pie in the sky promise with regards to what marijuana can do and what... those diseases where it really will be of help. But if you could just update us about some of the research that indicates just about how dangerous expansion of marijuana, especially with the bleed-down to younger individuals that we see, Whether it's e-cigarettes or marijuana, you can make it illegal, but young people are going to use it. So, if you could just briefly in the last two minutes discuss what's going on. Nora Volkow: (02:05:48) Thanks for asking that question because it's an area where there's been major changes in the perception of the American public that we have a drug that is benign and as a result of that we're seeing a very dramatic increase in the number of people that are consuming marijuana. 44.5 million in 2018. Of greatest concern of course relates to children because the brain is developing during until we are in the mid twenties. And the endogenous cannabinoid system, which is the one that's basically stimulated by marijuana is crucial in enabling that development, including migrations of cells, how cells communicate with one another. So what the research has shown is that kids, by adolescents consuming marijuana... There is a dose effect. I'm much more likely to show disruptions in terms of structure and function of the brain that appears to be associated with cognitive impairments. Nora Volkow: (02:06:42) The criticism that has been done of those studies is that they've looked at it retrospectively, which is the reason why we're currently doing the ABCD study that is looking prospectively to address specifically that question objectively in ways that cannot be challenged. What also has a marriage very clearly, and this is from stories that have come across all of the world by independent nations, is that the use of marijuana with high content THC is associated with a greater risk of having psychosis. Nora Volkow: (02:07:13) Now the big question is, is this acute or chronic psychosis? And there is now data to show that unequivocally that high doses of THC can make psychotic any one of us. Chronically, now that data indicates that it does increase the risk that you could develop a chronic psychosis, whether you have the genetic vulnerabilities would recognize it now or not. And this again highlights why we need to provide information to the public so that they go with their eyes wide open when they make decisions of taking drugs, but importantly when we make policy decisions. Andy Harris: (02:07:53) Thank you very much. I yield back. Ms. DeLauro: (02:07:54) Congresswoman Lee. Barbara Lee: (02:07:54) Thank you very much. Dr. [Paunch 00:22:55], of course, we've worked together for many years on HIV and AIDS, on the epidemic. I co-chair the bipartisan Congressional HIV AIDS Caucus and we're still working together in a bipartisan way to make sure that we have the resources to address this epidemic. We're at the tipping point now in the field of HIV research, including vaccine development. So just I'd like to ask you if you have an update on the future progress in these areas in terms of vaccine for HIV and AIDS. Barbara Lee: (02:08:26) Secondly, I'd like to ask you just in terms of the coronavirus, has it hit a pandemic level or not, and how do we explain to our constituents the difference between an epidemic and a pandemic? And I want to find out as serious as this is, how do we make sure that the public... Well, I think we're doing a good job in explaining how to prevent the transmission of the virus. But given that there's a 2% fatality rate for this virus and it's impacting people who are elderly, I wanted to find out, do you think that from your perspective that 2% is accurate right now in terms of fatality rates. Barbara Lee: (02:09:07) And then to Dr. Collins if we have time just on sickle cell, how close are we now? I mean you've done some remarkable work on sickle cell disease and we're waiting and I know we're close. Of course, one in 10 African-Americans in the US have sickle cell. Well, at least the trait. And so we wanted to just see how close we are and how we are doing as it relates to identifying the trait early enough where those who have diabetes recognize that the A1C test is not accurate or could provide false results. Anthony Fauci: (02:09:42) Okay. So I'll be really quick because you had a lot of questions. So vaccine. As you know, we had a disappointing situation with the vaccine trial that was fondly looked at by the DSMB in South Africa, which was called HVTN 702 which was using the model that we use in the Thai trial, and they showed safety, no deleterious effect, but no efficacy. There are two other major trials that are going on, one in Southern Africa, one in the Americas and Europe. Those trials, we won't have the data on them probably for at least another couple of years. They are using a different concept. They're using a different vector. They're using a different protein and they're using a different adjuvant. So I can't give any prediction of what it's going to be. But simultaneous with that, there's another whole effort on HIV vaccines using structural biological approach to get the right confirmation of an immunogen to induce broadly neutralizing antibodies, which are the gold standard of protection against viral infections. So there's still a lot of good work going on, but we did have a disappointment. Anthony Fauci: (02:10:50) Number two, the word pandemic... There are many, many people who have different descriptions and definitions of whether "pandemic". " Pan" being "all" means "widely distributed". The WHO has not declared this a pandemic yet because they haven't had very sustained transmission throughout the world, so technically it's not a pandemic. It will be up to them to make that declaration. Anthony Fauci: (02:11:16) Next, the 2% mortality. A report just came out today that when they looked at the totality of the data in China, mostly equals 90 plus percent of the infections are in China, it was somewhere around 3%, up from the two. The percent mortality will depend on what the denominator of number of cases. So if you're not counting every case, then the mortality would be high. If you're counting a lot of cases that are subclinical, the mortality become low. But no matter how you slice it, it's many, many, many more times lethal than the influenza that we get in a season. Particularly for the elderly and those who have underlying conditions. Because most of the deaths in the hospitalization, the mean age is like 70. Barbara Lee: (02:12:10) I kind of quickly- Francis Collins: (02:12:11) Very quickly, and my colleague Gary Gibbons is very much in the lead of this effort. We have a whole cure sickle cell initiative that NHLBI is leading. And the good news is here we now have at least three clinical trials in gene therapy for sickle cell disease that appeared to be working and working dramatically. They're very high tech. They require very specialized technology and hospital services so it's not quite ready for broad extrapolation, but we are going to see, I think in the next few years, sickle cell disease becoming one of those conditions that we can actually cure. Francis Collins: (02:12:44) In fact, we have started a new initiative with the Gates Foundation to figure out how we might extrapolate that to Sub-saharan Africa, which is where most people with sickle cell disease live, and where it would be unethical, I think at this point, to say we're fine because we figured out how to do this in a high tech environment. We have to figure out how to do it in a low resource setting as well. The interaction with A1C and sickle trait is now well recognized, I think, by many physicians. It was a very significant jam of publication that laid out exactly the data about this about a year ago. So I think there has been a recognition that this has to be paid attention to when managing diabetes with somebody who has sickle cell trait. Barbara Lee: (02:13:19) Thank you very much. Ms. DeLauro: (02:13:19) Congresswoman Clark. Katherine Clark: (02:13:24) Thank you so much. I was delighted to hear this morning the story on NPR about the incredible advances, and you did a very good job, Dr. Collins, on injecting a virus into the retina and potentially restoring vision. It's unbelievable. But I know that there are many concerns also with CRISPR and these technologies after the Chinese scientists edited genes of babies last year. So I know there's great work going on about putting up the sort of ethical guardrails that we need. I wonder if you can tell me what steps NIH is taking to protect patients and mitigate wrongdoing as we continue to push the boundaries of science and medicine for amazing cures. Francis Collins: (02:14:24) Well, this is an area of intense interest for all of us. And it is this remarkable circumstance where the application of CRISPR CAS, so-called gene editing for many different genetic diseases. And you mentioned the one that was just reported about this morning, which is a cause of blindness is one of the most exciting things that's happening right now in terms of research. Let me make it clear. Those approaches basically approach a way to fix the spelling of a misspelled gene somewhere in the body, but it doesn't get passed on to the next generation. It's non-hereditary. What happened in China was an intent to actually make this kind of change in an embryo, which would be what you call the germline of the hereditary changes, and we all agree that that is utterly inappropriate at the present time. There's so much we don't know about that. So many risks, so many theological and philosophical consequences to beginning to change our own instruction book. We at the NIH would not support that. In fact, that would be illegal in the United States, that kind of embryo manipulation. Francis Collins: (02:15:22) The World Health organization has a high level panel that is looking at this and we wait for their recommendations, and so far they've also come down quite strong on this. Our National Academy is in it as well- Katherine Clark: (02:15:31) Do you know when to expect that recommendation? Francis Collins: (02:15:34) The WHO recommendation? I think probably in the next few months, sometime during this calendar year, from what I hear, they're beginning to close in on some sort of conclusions. Again, WHO has a challenge because they've got to get all those countries to sign onto it. So there'll be a draft and then we'll sort of see what happens. Certainly in this country that would not be something we would do. But at the same time there's all this promise if you don't deal with the hereditary applications, but what we call the sematic cell part, you're dealing with the eye, or amid the liver, or maybe the brain for a child who has otherwise an untreatable genetic disorder, this is potentially enormously exciting. Francis Collins: (02:16:11) We have a whole program at NIH and our common fund trying to develop the ways to deliver that gene editing apparatus safely to the tissue where you want it to go. Because it's one thing you know how to do it in the cell culture, but in a person, how do you actually send it to the right zip code and have that result happen safely and effectively. There's a lot going on in that space and made a pretty big investment. For me who's a geneticist, these 7,000 genetic diseases waiting for some kind of solution, this is a scalable approach that might actually work, not in the next hundred years, but maybe in the next decade. But we have to work really hard to knock down all the barriers. Katherine Clark: (02:16:49) Thank you. Dr. Sharpless. It came to my attention recently through crackerjack staff that 20% of cancer trials fail due to insufficient patient enrollment because there are barriers as restrictions on elegibility, access to transportation, et cetera, ability to take time off work. What efforts is NCI undertaking to enhance clinical trial recruitment and operations at smaller community sites that may not traditionally be engaged in clinical research? Ned Sharpless : (02:17:27) Thank you. A really important topic. Clinical trials accrual was sort of the whole, the whole foundation rests on being able to recruit patients. And we have so many trials and so many great ideas in cancer, but if we can't test them, then we really can't make progress. So fixing this problem is an intense focus for the National Cancer Institute. I think one big issue is trials in prior era were designed poorly. They were designed to be done in inner tertiary care centers only, and not to be done in the other sorts of environments, and required just a process that was bad. And so one of the things that's happened in the last few years is a real focus on these sort of basket trials that can be done to the community. So the NCI match trial accrued 6,000 patients at 11,000 sites, for example. Ned Sharpless : (02:18:10) We have this in-core network that has these sites that allow people to get to accrue to trials in the community. We know that being on a trial provides better care and also provides a more diverse population on the trial. So it's really important. And lastly, I should mention we have made it a crusade to get rid of these arbitrary and somewhat silly eligibility enrollment criteria that keep people off trials like HIV positive or treated brain metastasis or things like that. We're working with others in the community, and the oncology community have tried to make trials simpler and more doable in the community. But it's still an area where we need some improvement. Katherine Clark: (02:18:40) Great. Thank you so much. Ms. DeLauro: (02:18:42) Congresswoman Frankel. Lois Frankel: (02:18:44) Thank you again for being here. This has been terrific. So I have three questions. Okay. Number one is I had read a report or a study that women are feeling like doctors are dismissing their complaints. Number one, I'm curious whether or not there's any research on sex discrimination in medicine. Number two is where I live in West Palm Beach, seems like in the entertainment district, every other storefront is selling CBD. Florida has also legalized marijuana, so I'm just curious whether or not there's any research to show that either CBD or the marijuana is medically effective. Then my third is back my grocery store questions on coronavirus is I know you're not supposed to touch your face, but is it any part of your face? Where are the germs going? And if someone gets quarantined, how long do I they have to get quarantined for? And can there be repeated quarantines? I guess the better question is, do you think this is going to be a widespread issue in our country? Lois Frankel: (02:19:59) ... sex discrimination first. Ms. DeLauro: (02:20:00) Sex discrimination. Lois Frankel: (02:20:05) Yeah. Yeah. Francis Collins: (02:20:08) Dr. Bianchi. Diana Bianchi: (02:20:10) Certainly with regard to maternal mortality there's definitely discrimination and that women's voices are not being heard. And that is one of the aspects of the improve initiative that we want to address. That's the community-based initiative. We know that there is not only a dismissal of women's voices but also there's infrastructural racism. And we are definitely including that as part of this overall initiative. Lois Frankel: (02:20:39) Like CBD and marijuana. Francis Collins: (02:20:42) [inaudible 02:20:42] Nora. Nora Volkow: (02:20:43) We know that there is evidence from CBD to be effective for helping to treat seizure disorders in children, Dravet Syndrome, and that has led to a medication. Otherwise there are no other FDA products approved for CBD, but there is interest with respect to its analgesic effects. There is interest with respect to its anti-inflammatory effects. And we also definitely are interested on our evaluating its potential therapeutic value to help treat different types of addiction, including opioid addiction. With respect- Lois Frankel: (02:21:15) When you say interest, does that mean there's research being done? Or you're- Nora Volkow: (02:21:17) Research is being done. We're funding researchers to do this, both in animals and in humans. And with respect to the THC, the information is more limited. There is some evidence that it could be beneficial for multiple sclerosis, for spasticity from multiple sclerosis, also for pain indications. And otherwise the evidence is not very good in terms of its potential benefits. But researchers are doing studies, and we're funding researchers to do stories on PTSD, for example. Could it have a value? Lois Frankel: (02:21:49) All right, back to the coronavirus. Francis Collins: (02:21:50) Yeah. Touching your face. Lois Frankel: (02:21:52) So first of all, how do the germs get in you? Anthony Fauci: (02:21:57) Okay. So first of all you asked the question about touching your face. So the public health ways to avoid getting coronavirus are very similar to those to avoid influenza. And that is particularly as simplistic as it sounds, washing your hands as frequently as you can. One of the problems with respiratory-borne diseases is that they are spread either by droplets, gross droplets, someone coughs or sneezes on you. Or even a bit of aerosolized, where you can be sitting next to someone very closely and you don't cough and sneeze, but the virus can aerosolize and go- Lois Frankel: (02:22:32) So that means does it go into you through your nose, your mouth? Anthony Fauci: (02:22:34) That's what I'll get to. All right. So what it is, it will get in through a mucosal surface. That could either be your nose, your mouth, or even your eye. The reason for washing your hands is that people often do the wrong thing. That's why you hear us say cough into the crook of your elbow. Because people sometimes go like this, they'll blow their nose, they'll shake hands with you, touch a door knob. 15 minutes later you come by and do that, then you touch your face and that's how you get it. So that's the way. That's the first thing. Secondly, incubation period quarantine. The incubation period, the median time from when you get exposed to you get in a clinical symptoms is about five, 5.2 days. That's the median. The range is somewhere between two and 14. 14 is much, much more the outer limit. So when someone is suspected of being exposed, they either self-isolate or they get actually institutional quarantine for four days. Lois Frankel: (02:23:36) But you could have- Anthony Fauci: (02:23:37) 14 days. 14. Lois Frankel: (02:23:38) Could you have multiple self quarantines? I mean, what if you get exposed and then you stay home and then you get exposed again and you stay home. Do you have to get stay home every time you get exposed? Anthony Fauci: (02:23:47) Well, it depends on what you mean by exposed. I mean, if you are exposed to someone who has documented infection and then you are tested and you go into voluntary isolation, not necessarily quarantine. The only time you get quarantine is if it's very, very clear that you have direct contact with someone. Lois Frankel: (02:24:10) But it could be multiple times. Anthony Fauci: (02:24:12) Well, it could be if you're in a situation where you're in an outbreak. Well, that's very interesting because when you go from containment, which means to preventing the spread, to mitigation, which means in the community distancing yourself socially. If, I don't want to say when because every time I say when it's a headline, if it gets to the point where there is really widespread infection, if that ever happens or- Lois Frankel: (02:24:43) Do you expect that to happen in our country? Anthony Fauci: (02:24:44) I can't predict that. I cannot- Lois Frankel: (02:24:46) Are you worried about it? Anthony Fauci: (02:24:48) I don't worry. I try and just do things that can prevent it. Lois Frankel: (02:24:53) Thank you very much. I yield back. Ms. DeLauro: (02:24:55) Congresswoman Watson call. Bonnie Watson Coleman: (02:25:01) When there's a vaccine , who gets it first besides my colleague to my left? Dr. Fauci, who gets it first and how do we go about distributing it? Anthony Fauci: (02:25:14) Well, the standard approach when you have a vaccine, for example for influenza when you have limited vaccines, you give it to the most vulnerable. And the most vulnerable clearly are the elderly and those with underlying conditions. And those generally are heart disease, chronic lung disease, kidney, diabetes, and obesity. Or those who are on immunosuppressive drugs who might have an underlying cancer. Bonnie Watson Coleman: (02:25:40) And so we're 18 months or so away from that? Probably? Anthony Fauci: (02:25:46) Least. The other thing that's important is that the health care workers and those who are the front line responders, because those are the ones in every disease we know that are the most vulnerable. In fact, if you look in China, the people who are most vulnerable before they had good PPEs were the health care providers. Bonnie Watson Coleman: (02:26:09) Thank you. Dr. Collins, following up on my interest in the whole issue of health issues and the disparate impact on minorities, one of the things that I learned from the emergency task force that we had on mental health and black youth suicide was that researchers, black researchers in particular, have not been having their research requests considered and they've been denied these requests for reasons having to do with not commuting catering clearly what it is that you're looking at, the implications of community, outcomes or collaborations not necessarily recognizing the significance in our space with regard to issues of that nature. One of the things that one of the institute directors talked about was having more workshops, having more input from black researchers into what would be considered and whose grants and stuff would be considered. What are the things that we can do to ensure that researchers of this nature are getting an equal opportunity to do the research that's important for the disparities that exist in the minority communities? Francis Collins: (02:27:33) This is an issue that we are looking at with great seriousness since it was documented a few years ago that in fact an African-American investigator who comes to NIH with their best and brightest ideas has a lower chance of getting funded than other groups. And that's very disturbing to look at. And there were many hypotheses about what might be involved. I think we have not completely sorted out all the reasons, but we've discovered a number of them. And certainly part of this issue does relate to, I think, the fact that oftentimes African-American investigators may not have been in as a strong position to be able to put forward a grant application because the lack of mentoring, the lack of opportunities to sort of be involved in networks, which may be a natural thing for others but for minorities not so much. And we are working very hard on ways to do a better job of mentoring with something like the National Mentoring Research Network. Francis Collins: (02:28:26) We also identified the fact that there are different areas of research where minorities tend to migrate. And health disparities research is one of those and you can see why that is. That's oftentimes a passion for somebody who gets into research who comes from an underrepresented group. They want to work on understanding why their communities are not being as well served. And yet it is clear that some of the research that goes on in that space doesn't fare as well in our peer review system, regardless of whether the applicant happens to be a minority or not. So there's some action there that we need to take. We're still trying to sort this out. There was a paper we published a few months ago about this, which got a fair amount of attention. We're continuing to do the analysis to see what else we're missing here. We are determined to sort this one out. Bonnie Watson Coleman: (02:29:12) Well, I'm glad. I am both a cofounder of the Congressional Caucus on Black Women and Girls. And we're interested in those things that impact individuals, particularly because of the intersection of their gender and their race, and as well as the interest in what's happening with our children and mental health disparities and things of that nature. Big issues in my community. So I thank you for the work that you're doing. I look forward to the work that you'll be doing in the future. Thank you. I yield back. Ms. DeLauro: (02:29:44) Thank you. We are going to do a kind of a third round here with three minutes each. But I wanted to let you know, I've just been informed, I do not know what the dollar amounts are, but it would appear that the House and the Senate, Congressman Cole, have come to an agreement on the supplemental. God's in his heaven, all's right with the world. And so we actually just got that notice and so that word will be getting out about dollar amounts, et cetera, et cetera, et cetera. So again, yes. Wonderful. This is where we need to go. I'm am going to do my rapid fire piece here again. Just, is this Dr. Gibbons, a status update on NIH's efforts on a Commission on Lymphatic Diseases. Okay? NCI, you talked about lots of activity in the area, Dr. Sharpless. Tell us a little bit about what's driving the interest in cancer research, because you have so many more. I would love to know at some point, and maybe I'll just sit and talk with you about where we stand with ovarian cancer and finding a marker for ovarian cancer. Ms. DeLauro: (02:31:01) Universal flu vaccine, update Dr. Fauci. If we could provide additional resources in 2021, how quickly might we move to some success there. And Dr. Collins, the NIEH, in past emergencies they have supported training for workers, for healthcare workers, airports, correctional institutions, et cetera. Just a quick overview of their worker training activities in recent public health emergencies, H1N1 flu, pandemic Ebola, and how could they support what we need to do for this current COVID-19 outbreak. So status of the Commission on Lymphatic Diseases. Gary Gibbons: (02:31:52) Sure. Anthony Fauci: (02:31:52) It's a lightning round. Ms. DeLauro: (02:31:53) Lightning round. Right. Gary Gibbons: (02:31:54) Exactly. So hit on an important area and that's often debilitating, disproportionately effecting women in lymphedema. We have established a task force that is trans-NIH that is focused in on this issue. Certainly it's one where we spend at the NHI over $20 million a year in that space along with, again, many other ICs contributing even more to that collective effort. One of the key areas that I might note in particular is part of the cell atlas that Dr. Francis Collins described in which we're able to get single cell resolution characterization of many cells in the body. One of the key organs, if you will, is the lymphatic system. And so understanding that system, both in normal human health and development as well as in response to injury and disease, is fundamental to really getting to better treatments for that disease. Ms. DeLauro: (02:32:53) We'll have further conversations on this. But we did encourage in the omnibus a National Commission on Lymphatic Disease. So we're going to pursue that with you. NCI, what's driving this interest? Ned Sharpless : (02:33:06) First of all I'd say it's a really good problem. Ms. DeLauro: (02:33:07) Yes. Ned Sharpless : (02:33:08) I mean, I think all these people were coming with great ideas. Ms. DeLauro: (02:33:09) Amen. Amen. Ned Sharpless : (02:33:09) That's what drives science. Ms. DeLauro: (02:33:11) We've got to be able to fund them too. Ned Sharpless : (02:33:11) It's probably a lot of things. I think the National Cancer Center Program plays some role. I think our low pay lines, frankly, people just write more grants. But the main one, I think, the really inherent one is the exciting time in cancer research. There's scientific progress. I saw this at the FDA when 30% of the business in terms of new approvals and devices and drugs were cancer related products. I see this in Big Pharma. I see this in basic science. There's just a lot of people who think they have good ideas for cancer. So I think that's the main one, and I'd be happy to follow up with you on ovarian cancer. Ms. DeLauro: (02:33:39) Yes. On ovarian cancer. There's still, after all these years, we don't seem to have a marker. Ned Sharpless : (02:33:44) Agreed. Ms. DeLauro: (02:33:44) And we know how many thousands of women die every year from ovarian cancer. Dr Fauci, universal flu vaccine. Anthony Fauci: (02:33:51) Thank you very much to the committee for the plus up on the universal flu vaccine. We're making significant progress. As I mentioned last time, the first in human Phase I trial for a universal flu vaccine for the group one influenzas, which is a whole cluster of influenzas, went into clinical trial. It was successful. It showed to be safe and it showed to be immunogenic. We will start very soon a Phase I trial for the group two, which is the other whole group of influenzas. So we're really moving along very, very quickly. By the end of the summer we'll be able to go into a Phase II trial. That's going to be important, because that's going to involve hundreds, if not a couple of thousands, of people. And we will need the resources that you gave us to be able to do that Phase II trial. Thank you. Ms. DeLauro: (02:34:37) And I would assume additional resources- Anthony Fauci: (02:34:38) Yes. Indeed. Ms. DeLauro: (02:34:39) ... in that process. Anthony Fauci: (02:34:40) No, I mean, that you, well, that you're going to give us. Ms. DeLauro: (02:34:44) Yes. Amen. Amen. Francis Collins: (02:34:47) Very quickly, and NIHS has played a critical role in training people who can deal with outbreaks. They previously worked on Ebola. They're totally prepared to step in in this space too, need some support for that. And basically it's airports, as you said, it's correctional facilities, it's hospitals. They both do train the trainer efforts. They do face to face. They run courses. Ms. DeLauro: (02:35:08) You mentioned that you need some help with that. Can we be instrumental in pushing for NIEHS to be engaged and involved in the training, which is [crosstalk 02:35:19]- Francis Collins: (02:35:18) I'm curious and looking into supplemental and see whether there's a way that this can be factored into that, because they were going to meet a lot of training for people who aren't quite prepared for this yet. Ms. DeLauro: (02:35:26) Okay. Thank you. Tom Cole: (02:35:28) Thank you very much, Madam Chair. I want to follow up quickly, actually, on the point you raised with Dr. Sharpless. Because I want to add a little more information. We've got, obviously, explosions, as you pointed, going on for a variety of reasons. There are some things you should do so that we don't leave good science on the table, just because right now cancer seems to be a lane where there's a lot more happening than maybe some other areas? Ned Sharpless : (02:35:51) Yeah, I think there are ... probably the main thing to realize about this problem is that is not a one year problem. It's like a mortgage. We pay these grants, they have four and five and in some cases even six year budget tails. And so when we invest in the RPG pool and this pool of grants today, which goes up three, five, 8% every year at the NCI over the last five to 10 years, then that has out year costs for us that are quite significant. And so that provides some hesitation on the part of the NCI to be good stewards of our ... if we over-invest today, we could have a real problem three years from now if we're not smart about it. Ned Sharpless : (02:36:29) So this real realization that this problem is not going to be fixed this year or next year, that we expect that we're going to get these increased number of grants for a while, because there are people who just have a lot of really great ideas. So I think this sustained commitment that you've provided for so many years is really what the doctor ordered for the NCI RPG pool problem. Tom Cole: (02:36:50) Yeah, I think that's important. I couldn't agree more. Dr. Collins, the Attorney General was raised from awareness of threats posed by foreign governments that obviously are, particularly the People's Republic of China, frankly raiding our science or interfering with our research. Can you tell us what your level of concern is on that? Some of the measures you might be taking to respond. Francis Collins: (02:37:12) We are quite concerned. Dr. Mike Lauer, who is the head of our Extramural Research Division, has spent, probably two thirds of his time now on this over the course of the past three months. First, let me say that we greatly depend upon and value foreign investigators, foreign born investigators, who are part of our workforce, the vast majority of whom are honorable, hardworking, incredible contributors. And one thing we have to be careful of is that even as we've identified this as a serious issue, that we don't extrapolate into anything that would look like a sort of racial profiling, which would be a really unfortunate, unmerited, and unforgivable kind of approach. At the same time, we have identified numerous examples, I'm sorry to say, of individuals who have been receiving substantial financial benefits from relationships with foreign countries, yes often China, without disclosing that. And it is a requirement that they do so. Francis Collins: (02:38:06) Likewise, we have instances where individuals have shared grant applications that were not even yet reviewed with colleagues in other countries to give them some kind of an edge on developing some new invention. Obviously that has consequences for intellectual property. We are very serious about identifying those circumstances. You have probably seen in the press some dramatic examples of individuals who have been found to be egregiously against the way that scientists should behave and have, as a consequence, lost jobs. And in some instances has been brought forward for various kinds of criminal prosecution. Again, I think most of the people that you might see in our workforce are honorable, but we are determined. We are stewards of the public trust. If there are instances that are not going the way they should, we will be following up on them. At the moment we have dozens of these investigations that are currently underway. We're working with the FBI on this, and they've been good partners with us. And we will keep our eye on this and continue to see where the trouble is and then act upon it. Tom Cole: (02:39:09) I just want to commend you for your vigilance here. And frankly also for the evenhanded attitude there. There is a danger here that this could degenerate into a place none of us would ever want it to go. And so thanks for having the focus on the problem, but also thanks for remembering, as you say, most of the folks that are involved in these endeavors are honorable, able, and are serving humanity. So it's a tough problem but I think you've struck the right balance. Thank you, Madam Chair. Ms. DeLauro: (02:39:37) Congresswoman Frankel. Lois Frankel: (02:39:40) Well, at first I just wanted to say I want to thank our Chair and our ranking member and all our panelists. It is so refreshing and I think we're blessed to be able to have a bipartisan discussion on health research, and very fortunate to have people of your caliber leading the way. I'm not going to can I say more supermarket questions. I just note that I touched my face so many times today that I am, seriously, I'm very worried about the social and economic impacts of the potential of this virus. That's really very frightening. And I'm not going to get into with you guys, so I'm going to ask you some different questions. Specifically in Florida, and I also know in the nation, that suicides are a big issue. And also I saw something that it's a leading cause of maternal death. Is that right? That suicide ... no? Okay. I'm glad you say no. But I want to just combine these questions, because I'm curious not only about suicide research but also postpartum depression research. Francis Collins: (02:41:00) I'll quickly start with suicide and then ask Dr. Bianchi about postpartum, because that fits with our maternal mortality topic. Certainly suicides increasing in many different communities and demographic areas are of deep concern. And there are many diagnostics about why that might be going on that relates to people's sense of isolation, which is clearly a growing problem in this nation. We at NIH are aiming to do everything we can to identify the factors, and particularly the predictors, of who is at risk and what the interventions might be. And there are certainly some of those, such as trying to make sure that people don't have access to lethal force for that moment where somebody makes a sudden decision to end their life. And it's often a rather sudden decision. Francis Collins: (02:41:44) I will say also in terms of treating the clinical depression that often undergirds this, there is a major development that's happened which is the development of this drug called ketamine, which has this remarkable phenomenon in many people who've had chronic clinical depression and not responded to anything else, of after an intravenous infusion having an almost, within an hour, lifting of the clouds. That is now being tried in people who are acutely suicidal, and starting to look pretty promising in that space, if you can catch somebody before they take the drastic action and lift them out of what seems to be a hopeless circumstance. So that's one bright spot in what is clearly a very tough problem. Diana Bianchi: (02:42:24) Yeah. So NICHD is funding research that it currently is looking at postpartum women who potentially are at risk for suicide. So the difficulty with the postpartum situation is some of these women have no prior history of mental health problems. So how do you ... again, it's this rare issue where, how do you know if someone is going to be at risk? So we're funding an investigator who is actually looking and taking a machine learning approach through the electronic health record to begin to identify certain clues in the record. But the other issue is a lot of pregnant women are depressed, and they're taking antidepressants during pregnancy. So we need to know are these drugs safe to take during pregnancy and lactation? And there's an area where I'm concerned, because women who are at risk are not taking their medicines because they think it's better for the baby. And so we are doing research to show what is safe and what isn't safe. And we have a study called the Cuddle Study where women taking these medicines are donating their breast milk so that we can see what is actually in the breast milk. Lois Frankel: (02:43:40) Thank you very much. Ms. DeLauro: (02:43:40) Congresswoman Watson Coleman. Bonnie Watson Coleman: (02:43:40) Thank you, Chairwoman. Dr. Sharpless, I'd like to talk to you about endometrial cancer. I know that there are cancers have shown a lot of improvements in a number of deaths over the time. The National Cancer Institute's Surveillance, Epidemiology, and End Results program shows a worsening survival rate from endometrial cancer for 1996 to 2016. And the incidents rate for black women surpassed that of white women in 2007 and continues to increase to this day. The incidents of the more aggressive type two cancers is dramatically higher for black women than for white women. I'm wondering what your plan is, what's happening in that field, and what are you planning in terms of funding clinical trials and trying to come up with specific therapies that address these disparities? Ned Sharpless : (02:44:36) Sure. Thank you for the question. I think we are equally concerned by the statistics. You mentioned this is a cancer which is increasing in mortality in the United States. As I mentioned, most cancers are actually declining in mortality. The few that are actually showing an increased mortality are particularly of concern. Why is that happening? We think in endometrial cancer and a few other cancers, it may be partially related to obesity, as the obesity epidemic. Obesity is associated with endometrial cancer, but we don't think that's the entire explanation. The basis for the disparity is an area of active research between African-American women and other populations. This is a problem across many cancers, including endometrial cancer. Ned Sharpless : (02:45:15) Generally our findings have been that they are in part these social determinants of health, these access to care, these sorts of things, and partly often driven by biology and some combination thereof. And so we have funded efforts in endometrial cancer and other gynecologic malignancies specifically to address that question. We have a SPORE in endometrial cancer and other gynecologic malignancies, which is a Center of Research Excellence we're funding. And an area where we are devoting a lot of focus because of the worrisome statistics you mentioned. Bonnie Watson Coleman: (02:45:47) I yield back. Ms. DeLauro: (02:45:47) Let's yield to the ranking member for any final comments before we conclude. Tom Cole: (02:45:51) Thank you very much, Madam Chairman. This is always, I think like many members, this is always my favorite hearing of the year. And I think because we all marvel at your abilities and the work that you're doing and you're about and what your colleagues are doing. And we all see the good in these investments, and we all feel as if you'd been really good stewards of the money that Congress has chosen to put at your disposal. And we all think the American people, and frankly all of humanity, have benefited enormously as a result of those investments. I'm proud of this subcommittee. I'm proud of my chairman, who's been my partner in this for years. I'm proud of our colleagues on the other side of the rotunda who have worked with us for years. And I think it is absolutely critical, Madame Chairman, that that continue. Tom Cole: (02:46:41) Now I'd be the first to say, and I know my chairman knows this better than I do, this is going to be a very tough year. We have a two year budget agreement. It's essentially flat funding. And if you look at some of the requirements and a couple of the other departments that they're going to take money we know, veterans I'm thinking of in particular, my friend, the chairman and her counterpart, my friend Chairman Blunt, are going to be confronted with really tough decisions. And I've had this discussion over many years with Dr. Collins. I usually use the phrase we're in another one of those years where we're robbing Peter to pay Paul. Fortunately you're Paul, and somebody else is going to have to be the Peter. And that it's not your job to make those decisions, it's the job of this committee. Tom Cole: (02:47:29) And my friend the chairman and I have commiserated with this over this many years, because there's lots of wonderful things in this bill. Lots of things we agree on, lots of things that are national priorities. But I think this committee has made the right decision over the last five years in a bipartisan sense by probably making you the top priority in the bill every single year. And I don't think that's ever been more dramatically demonstrated than right now. How many questions did we have on coronavirus? And yet there'll be another coronavirus out there. And I thought one of the most telling answers at the hearing are when Dr. Collins made the point that these past investments have put us in a stronger position to deal with these current challenges. And I thought Mr. Sharpless made an excellent point, Dr. Sharpless as well, when we talked about the extraordinary opportunities we have in a particular area right now. And those opportunities come and you have to use the resources you have to take advantage of those openings. Tom Cole: (02:48:32) And you also have to make commitments that sustain themselves over years. I mean, the community has to think in terms, again, always of cumulative and incremental, whether it's investment in your fiscal infrastructure, or it's just thoughts about projects that clearly take multi-years to come to fruition. And we've got to make sure the revenue stream is there and available. So again, I thank all of you for the work. I thank this committee on a bipartisan basis for its sustained commitment here. And I think, Madam Chairman, the wisdom of that has been born out. And I hope we can continue that. And I know if it was up to you and me, I know it would be continued. And we're pretty persuasive with our colleagues sometimes too. We really make a pretty good team here, and in dealing with our friends across the rotunda who fortunately have approached this with the same mindset that we have for many, many years to come. So hopefully we can continue this because I think it will frankly render enormous benefits to the American people. And that's what all of us came here to do that. I yield back, Madam Chair. Ms. DeLauro: (02:49:41) Thank you very, very much. And through my dear friend and colleague and if I might add co-conspirator in what we do in the subcommittee. And indeed this is always an extraordinary. And it's a revelation. We have a doctor on our committee, Dr. Harris, but as far as I know, the rest of us are not scientists. We are not doctors. Tom Cole: (02:50:11) [inaudible 00:02:50:11]. Ms. DeLauro: (02:50:12) Well, yes. Tom Cole: (02:50:12) Just not that kind of doctor. Ms. DeLauro: (02:50:13) Right. You're a political science doctor here. But what we are about is trying to grapple with issues about which we spend time studying and learning so that we can try to do the right thing. You do every day in your life focus on a mission of which there is no nobler cause or highest commitment, which is to save lives. And we get to work in cooperation with you to make sure that we push the edge of that envelope. We need to do that with the resources that we provide you to do your work. I will just say this to my colleague that, yes you are Paul, but I always have, and you've heard me say this before, I have to worry about Peter as well, and looking at that. But I think you know where our hearts and our commitments are to make sure we go down the road. Ms. DeLauro: (02:51:19) I would just say one other thing. This is a committee in working together, which does not deal with gotcha. We are not sitting here to try to stump you to make a political comment. We are here to try to get the best information and the best advice so that we can respond. And when some of the questions are hard and they're tough, it is not for political purposes, but it is to look at our stewardship of public dollars and where those public dollars are going. And we are so trustful of you with being good stewards of the public dollar. And we can sell that, both my colleague and I, to other members of this subcommittee as well as the committees across the aisle with our Senate colleagues. I'm going to end on a humorous note. I'm going to have to stop hugging people, Tom. And I just want to make sure that, Dr. Collins, that people can afford ketamine. Okay. That's another issue that we could do. Thank you. The hearing is concluded. Thank you all very ... [inaudible 02:52:51].