Transcripts For CSPAN Hearing On The Fiscal Year 2017 NIH Budget 20160319

Subcommittee hearing is two hours and 15 minutes. It is my pleasure to welcome you to the subcommittee on health and Human Services and education to discuss the fiscal year 2017 National Institutes of Health Budget request. We are looking forward to hearing the testimony of dr. Whoins and his colleagues will be brought in for questions along the way. I would like to publicly thank dr. Collins and the staff at the nih for hosting me and other subcommittee members for a briefing at a tour at the nih campus a few weeks ago. I hope it will become an annual trek. Withinleft nih appreciation of the exciting work your staff to every day to find ways to save lives. I am proud than last year this congress was able to increase nih funding by 2 billion a night in confident that through these efforts one day we will find cures for diseases like cancer and alzheimers. Fore disappointed is the proposed budget cut to the. Ih this year the proposal to divert one billion dollars of Biomedical Research funding to the mandatory set a budget ledger and rely on new and possibly unlikely authorizations to continue the advances that we have made in increasing your Research Funding is sort. I do not plan to let the 1 billion cut stand. We need to ensure sufficient basic Biomedical Research bases that are sustained to pave the way for these longterm advancements. Propose new onetime mandatory spending that may never materialize is not the path to do this. Look forward to discussing the effects of the president s proposed discretionary budget cuts on your research this morning. I also want to stress how important it is to ensure that we continue to focus on the next generation of investigators to clean out on the takes for a new drug to make it from the lab to the patients and without a pipeline of young researchers committed to following the process, we will not be on a find a cure. I will be asking some questions this morning about a variety of issues like Institutional Development awards, alzheimers disease, the cancer moonshot are a hope to learn more this morning on the how and how the increases we provide to the nh this you are being used to move us forward to more to cure is is that these diseases that caused some are suffering in our nations with a much for i want to welcome dr. Francis collins, the nh director, the subcommittee, dr. Collins is accompanied by four directors who can assist in answering questions. The dr. Anthony faucher. Dr. Richard hodgins. Dr. Doug lloyd. Nora valco. As a reminder to the subcommittee and ever witnesses, we will abide by the fiveminute rule. Joined by both the big chairman as we like to call him in our Ranking Member. I will defer first to the chairman for any remarks he would like to make. The fiveminute clot is not apply to you. Clock does not apply to you. Welcome. You have exhibited the highest level of professionalism and dedication during a time of so much groundbreaking research. Protection. Cancer, nih has the right man at the helm to me the challenges that we face. The emergence of the zika virus throughout the western hemisphere, one of those challenges that you are undertaking, underscores the mission, tof nihs gain and apply knowledge to enhance health and reduce illness and disability. Since most of its recent , zika hasin brazil spread to dozens of countries. Although cdc does not anticipate anyone spread outbreak in the we have had 190 three travelassociated cases reported. The chairman and i and others just returned from a visit to south america. Leaders, health officials, talking about the virus. We are interested in hearing your thoughts on the role that into our plane to develop vaccines and therapeutics based on existing and future research. To 11 american exposure Going Forward. With various officials on that trip, particularly in brazil. And explored what they are doing to try to stamp out the exposure. And others in the region. Importance of nih wererch, i am proud and we able to work in a bipartisan fashion to increase your budget and fiscal 2016 2 billion to fund more groundbreaking medical research. This year, the nih budget request prioritizes basic foundational research, Precision Medicine, applying big data to improve health outcomes. In addition to the Public Health benefits that accompany your ofk, the Economic Impact medical research should not be underestimated. Nih Research Dollars not only Impact Research facilities and researchers, but they also help get new drugs to the marketplace. Through this funding, we have established a strong and theship between nih National Cancer institute. They continue to perform Transformative Research benefiting the entire country. We look forward to continuing our Work Together to bring an end to these devastating diseases. That being said, funding toward that goal must come through regular discretionary channels. That allow us to respond to needs as they arise. Disappointed to see the request cuts nih discretionary , includingbillion 57 million from the national abuse. Tes on drug the hole witheels over 1. 8 billion in mandatory money. However, i look forward to meeting your requirements for the regular appropriations process. We do not like mandatory spending. It has grown out of control. We have adequate Discretionary Spending for five years by almost 200 billion. In the meantime the mandatory entitlement side of the budget is soaring out of control. I came to congress, we are appropriate or two there is a federal spending. Now it is one third. Now there were two thirds in growing in this deal with it, we cannot even pay the interest on the debt. With discretionary funding. So, that is why we are so dead set against mandatory increases. We need to keep control of the spending that takes place which is the only accountable and to with theora volcow spirit she has been a champion for events and assigns drug abuse and addiction as a director of the National Institute of drug abuse for 13 years now. Be on her personal expertise in imaging, shebrain has been with us since the beginning of our battle against drug abuse and southern and eastern kentucky. I am anxious to hear about your recent efforts regarding the abuse of prescription medications. As you know, this epidemic runs rampant across the nation. I hope you will update the committee on your work with pharmaceutical companies to evaluate the risk associated with longterm use of opioids and what nih is doing to Research Abuse deterrent medications and opioid alternatives. I am also pleased that you have once again committed to sharing these insights of National Prescription summit in atlanta. We are excited about you being here for this one. That others on the subcommittee will be able to make that summit as well. I look forward to hearing from you today about your pursuit of the adolescent Brain Cognitive Development study. Collecting extensive data on the effects of marijuana and other drugs, a Young Persons brain will help us finally appreciate the harm these substances can do overtime. Law is clear, if states continue to rush to decriminalize over legalize marijuana, despite the lack of sufficient scientific that saids use it help close the cap and hopefully shift Public Perception back to reality. Steamedciate this very panel being with us today. We look forward to working with you during the year to make sure that you are doing what the country expects of us. Thank you. Moving next to our Ranking Member, the distinguished lady from new york, miss lloyd. Thank you for holding this very important hearing. It is a pleasure to be with you. This is one of the most exciting hearings i attended every appropriation session. Theuld like to welcome doctors. I would also like to thank each of you for your service and it is because of your vision and to provide aon Bright Future for millions of americans suffering from illness and disease. Im very pleased you are here to discuss important investments in Biomedical Research and the health of our nations. Thank you. I must say was thrilled as i always am to meet with many of you at the nih two weeks ago. During our meetings, i saw firsthand the lifesaving breakthroughs, including gene therapy to treat patients, torahigh field mri machines look at the brink, allowing for advances in alzheimers and other brain diseases, and clinical studies that are improving Mental Health and reducing suicide and so much more. These breakthroughs in the need is whyitional research this committee thought to increase funding for the nih by 2 billion in fiscal year 2016 omnibus spending bill. Nih has the worlds best physicians, researchers, technology. I worry that even a 2 billion investment will not go far enough to ensure that the nih can compete against Foreign Research initiatives. It does not serve our National Interest if there are not enough brands to support young researchers over if researchers are lured away Foreign Countries to develop medical breakthroughs abroad. That is why last year, although i was pleased with the 2 billion increase, i called on this committee to once again commit to doubling funding for the nih. I was here when that bipartisan and i do, myde colleagues on both sides of the aisle to double the funding for the nih puritan we cannot afford to let some of these brilliant researchers not get the support they need. Your fiscal 2017 budget request would be a positive step toward that end up your budget includes target investment such as the cancer moon shot, increases imprecision that is, the great initiative, in addition, it would result in 600 Additional Research project these investments not only fund research, they were greatly reduce the cost associated with treatment and down the line. By the way, i must say i had the watson, theto visit ibm Research Center in my district just last week. In fact, i am not sure i understood everything they were explaining to me, but what i paid particular attention to was a coordinated effort between watson and other Research Facilities in your precision it is sotive amazing to me that Precision Medicine and the research that is being done at the nih is coordinating with many facilities and i understand my followup, watson is the only place. So, dr. Collins, i would love if you would touch on that as well, the coordination that is going on. The amazing work to think could get her cancer analyzed at the nih and other facilities out there and in the same that could certainly help lead us to new discoveries and new cures. Let me say, however, while representing a net increase of 825 million, your budget will result in a one milley one billion dollar cut it discretionary funding for nih and i assure you, that this chair and Ranking Member in the chair iin the big will just not let that happen. Funding is of concern. Finally, in addition if you can get it, good luck to you that would really be great. Finally, in addition to your budget request, the nih is also awaiting congressional action on the emergency supplemental to combat zika. The world is looking to the United States to lead and i and concern that delaying consideration of the emergency supplemental is leaving the american public, particularly women who are pregnant or could soon be pregnant, at severe risk. And i know you are doing Additional Research. I am still not satisfied that only pregnant women can suffer from zika, i know we have touched on that in our discussions. But the bottom line is, we are already behind. We must act. I urged committee and congress to meet this need without delay. Thank you, mr. Chairman. We now go to the gentlelady from connecticut. Thank you. In this any yankee fans audience, you will know the term a murderers row. I want to look at this group this morning as survivors wrote. You are, indeed, allowing people to survive. As i have said in the past, you give the gift of life and we are so honored to have you here this anding and to listen to you have the opportunity to have a discussion. Mr. Chairman, i want to welcome ,veryone and as we discussed the nih is the leading Biomedical Research entity in the world. With each scientific discovery, asian medical breakthrough, its Research Advances human knowledge, improves the quality of our life in saving lives. Funding this research has the power to do more for more people than anything else within the purview of our government. Who has to we were able to provide a significant increase of 2 billion dollars for the nih. I want to say thank you to the chairman and all the members of theirbcommittee for bipartisan work to support nih. The additional funding is helping nih accelerate research to find cures for cancer, alzheimers, and help them move forward with exciting new the Precision Medicine initiative in the Brain Initiative. However, i was disappointed to learn that funding for hivaids research is not increasing in fiscal 2016. In his 2006 in budget request, and age propose an additional 100 million for hivaids research in order to advance his work on universal vaccines to prevent hiv infection. I think it is mistake to change nihse and i hope to see support their research this year and it is something i will advocate for. In plays an integral role responding to emergency Public Health threats. , nih as ebola raged accelerated its work to create any bowl of vaccine are recently, nih has been working to develop a vaccine to address crisis whichika poses an urgent and serious threat that my colleagues to take a look at yesterdays New York Times. Pregnancy is shattered by fear of zika. Of womenn the minds particularly. I look forward to hearing from the doctor about the current status of ebola vaccine candidates as well as progress zika vaccine two Clinical Trial. Some of my colors have expressed the desire to shift unobligated funding the congress provided for ebola to respond to zika. I strongly oppose that idea. I would be anxious to know what activities we would have to forgo if we shift funding away from ebola to zika appeared we need to be able to respond to multiple Public Health threats at the same time. Congress in in this the last congress i proposed funding a Public Health Emergency Fund that mirrors a Disaster Relief fund which would enable the federal government to immediately respond to Public Health threats. I would also urge the nih to use its Statutory Authority to respond to the rising cost of Prescription Drugs. As you know, when taxpayerfunded Research Results and age maytent, require the Patent Holder to license the resulting intellectual property to a third party. The resulting in competition that drives down drug prices. It is outrageous that drugs invented under tax payer funded sicks can cost the americans hundreds of thousands of dollars over the course of a year. The public pays while nah is funded at 32. 1 billion, that funding has not kept pace with the rising cost of Biomedical Research. Fy2016 funding level 2003ins 7. 5 billion below level adjusted for by medical inflation. Funded one innih three research grants. Today, it has fallen to one and five. The slight improvement over recent years but still low for historical standards. We are missing opportunities to work towards cures for life altering diseases affecting far too many people. That brings us to todays topic, the 2017 budget request. I applaud the ambitious proposal to include Cancer Research in 2017. As a 30 year survivor of ovarian cancer, you have heard me say it before, im alive because of the grace of god and Biomedical Research. Im pleased to see proposed increases at 100 million and 45 million for the Precision Medicine initiative and the Brain Initiative. These initiatives have the potential to revolutionize our understanding of the disease as well as our understanding of longterm physical and Mental Health. I think we can do better. We need to continue to develop consequencesr risk of antibiotic resistant bacteria for our Public Health. I want to note my concern over mandatory funding for nih. It is the responsibility of this committee to fund the nih. An increase for this subcommittees allocation is thi the responsible way to support Research Rather than relying on mandatory funding that will not materialize. We should continue to uphold the longstanding tradition of scientific independence and set ting federal Research Agenda rather than override scientific judgment with congressional preferences. That ability to allow this scientific independence has been in hallmark of this subcommittee. I had the opportunity to introduce a bill last year that would enable our committee to increase nih funding 50 over five years by providing a tax adjustment. , integrityhat we do funding, we have a model. We should be able to do this for the nih. That would ensure proper funding for Research Without other vital programs to do so. Thank you again for everything that you do. Biomedical research is one of the most important investments that we can make as a nation. It gives us the gift of life. I look forward to your testimony in our discussion. Now, dr. Collins, we will go to your Opening Statement. Dr. Collins good morning. The committee,of my colleagues and i are delighted to appear before you today. We were honored to host you at nih with several of your committee members. Lets do it again next year. Of i think that was extremely helpful for us to have you on our campus. I had planned to reflect more broadly in my Opening Statement here than usual on nihs contribution to the nations health. Double break with tradition and make some predictions. 10 areas in which i believe we can expect to see major progress 10 years from now, given a sustained commitment of resources for nih. This is 10 for 10. Here we go. The long arc of scientific discovery must begin with basic science. Experiments that are going on right now across the nation contain the seeds of breakthrough discoveries that will transform medicine. Lets fastforward to 2026 and the first of these 10 breakthroughs. I think that will be advances in analysis of individual human cells. It is the unit of life. Cells for biology like atoms are for chemistry. We have not really have not really had the technical ability to study individual cells. We have had to deal with millions of cells. New technologies just invented in the last couple of years is all changing. That is just one example. We can now decode the process by which individual immune cells attack and destroy healthy tissue in autoimmune disorders and transform the ways we approach lubitz, multiple sclerosis and other diseases. Breakthrough number 2 in 10 years time, tools developed through the Brain Initiative will identify hundreds of different types of brain cells and major circuits responsible for motor function, vision, memory and emotion functioning at the speed of thought. As a result, we will be able to diagnose conditions earlier and more precisely. We will have new targets to explore for prevention and. Reatment schizophrenia, parkinsons disease. Initiativee brain through imaging techniques and discoveries made with our private sector collaborators, i believe we will be able to identify individuals at high race for alzheimers disease even before any symptoms appear and provide them with effective therapies. Personal and family tragedies will be delayed or averted. The economic savings from this alone will add up to hundreds of billions of dollars. Number four, i predict 10 years from now we will have developed an effective treatment for spinal cord injuries. Groundbreaking nah reserve has allowed for young men paralyzed from the waist down to walk with the use of electrical stimulation that bypasses the severed cord. Resources are available to follow up this group of concept study. We can give freedom of movement back to victims of Car Accidents and other spinal trauma. Number five, we will see the introduction of a safe and effective artificial pancreas. For those with diabetes, such a device will continue really track changes and provide andise doses of insulin preventing countless complications. And major cause of death his Heart Failure in this country. The development of induced stem biopsyerived from a skin that opened up her bow new opportunities for organ replacement. Early experiments suggest a patients heart could even be rebuilt using his or her own cells. This personalized rebuilt heart would make transplant waiting lists and antirejection drugs obsolete. Number seven, new vaccines will be readily available. Universal flu axes scenes will protect against all strains of the virus, preventing worldwide pandemic saving millions of lives and eliminating the need for an annual flu shot. Early Clinical Trials are already underway and we are in active collaboration with industry. Im optimistic ineffective vaccine for hiv aids will be available by 2026, to finally bring an end to this most frightening and costly global epidemic. Structuralt, genomic biology will unveil entirely new targets for the treatment of pain, allowing researchers in the public and private sectors to develop highly effective, not addictive medications for pain management, turning around the current alarming trend of massive of numbers of americans becoming addicted to opioids. Number nine, we will have tailored approaches to medicine that acknowledges not every person is the same thanks to the Precision Medicine initiative and the more than one million volunteers and the National Research cohort. The willingness of these participants to share a wide variety of their Health Related information will ensure major new insights emerge and americans will be healthier than ever 10 years from now. Ast but not least, i predict decade from now, hundreds of thousands of individuals will be thriving. Our whole new group tension strategies will be accelerated by the Vice President s cancer moonshot proposal. Consider what is happening right now. Seven months after president jimmy carter revealed melanoma spread to his brain, that he is beginning therapy to boost his immune system, last week he announced he is cancer free and no longer needs treatment. Our nation needs more stories like this. The sustained efforts of the subcommittee, i think it is possible. Therong stable trajectory, world to a healthier and happier future whether it is 10, 50 or 100 years from now. Thank you, mr. Chairman. We welcome your questions. Thank you, dr. Collins. Just for informational purposes, i will ask my questions and then go to the chairman of the full committee and the Ranking Member and then my good friend the Ranking Member of the subcommittee. We will proceed with questions. As i mentioned, dr. Collins, although the Administration Budget appears to request an sncrease, that increase i outside of our jurisdiction as a committee. The administrations request before this Committee Proposes a 1 billion cut in the area we have jurisdiction over, Discretionary Spending. If we were to appropriate exactly what the administration requested in your budget on the discretionary side 1 billion cut below current levels what would the impact on Biomedical Research in general be and on research into diseases like alzheimers and cancer specifically . Dr. Collins a very sobering scenario you portray and what we hope will not happen. The impact would be severe. It would be felt across every aspect of what nih supports. All of my colleagues here and the other 23 institute and Center Directors would have to cut severely back in their programs. New initiatives would not be able to get started with a you are talking about cancer, diabetes or Heart Disease or all timers disease. This would represent a very sick of it slow down. Again, im just a simple doctor so the idea of how you divide up appropriations between discretion and mandatory is a little over my head. Pleased in the president s budget to see a proposal for an increase and very gratified by your word of the intention of this committee to figure out how to maintain the trajectory you started with the 2 billion increase. I cannot tell you what a shot in the arm that has been for our Biomedical Research community. The morale, the enthusiasm and the willingness to take risks as our projects which have been in a slowdown for about a decade is back. We want to be able to see that continue and appreciate your support. Let me ask you the upset of the question. Ive talked to the chairman of the full committee and the Ranking Member made her feelings known. This committee is not going to cut 1 billion in discretionary funding from the nih. It is not going to happen. In that sense, you dont have to worry about that. But, lets say last year, the president proposed a 1 billion increase which was very welcome. This committee working in a bipartisan fashion was able to double that. Lets assume we were able to go beyond what the president asked 2. 8, beyond the 3 billion. If we were able to give you extra money, where would you direct it . Dr. Collins what a wonderful question. There are a lot of areas that are right for expansion and the opportunity to be able to go even faster on those would be welcome. As you know, great deal of the research we support is ideas that come to us from investigators all over the country. Very bright brains that push for the envelope and we want to be sure to do something to encourage even more of those grants to be fundable. We are still under 20 for that success rate. That would have a fax across the board. Any microbial resistance will have more resources put into it. , so many things are possible now. Abuse andse other drug abuse diabetes, conditions of these which are scientifically poised for rapid investments would have their opportunities lifted by this kind of wonderful scenario you portray. That is wonderful. Lenny moved to another area. I saw a recent Time Magazine article on alzheimers which highlighted the early stage Clinical Trial which i understand to be nih supported basic research. In my visit to nih, it was interesting to learn how to increase from congress has science onerreview alzheimers disease and other dimensions. If you could, i dont have a lot of time, but tell us where you are at and what you see the prospects are in alzheimers and dementia . Thank you very much for the increased funding this year which has made in a norm is different. Enormous difference. The opportunity we are learning about the brain and alzheimers disease has expanded enormously so the resources are very applicable. In preparation for the bypass budget that we submitted for the first time last year and congressional direction, we underwent a very extensive Planning Project where experts identified priorities. What we had to achieve to excel therate accelerate intervention in the nearest possible terms. This meant with additional funds, we were poised to act on this. S full spectrum of priorities and milestones. Embarking upon looking at the most basic biology, genetics. Understanding new targets for intervention. Clinical trials take advantage of the most promising. People who have already disease and have cared rivers that take so much responsibiility. Heath disparities, epidemiology. We have seen a huge increase of applications, scientists were been inspired by the availability of resources. We see a very Bright Future for accelerated progress thanks to the supports of congress. I violated my own role and asked you a tough one near the end of my own time. I want to move next to the chairman of the full committee. Thank you, mr. Chairman. You for boththank actively engaging the issue of Prescription Drug abuse. We lose 100 americans a day from overdoses of prescription medicine and haroleroine. We need a holistic, multipronged approach to the epidemic the sayssays we have cdc we have. Let me explore a sizable part of the problem oversupply of opioids. 250 million prescriptions are written each year for opioid, many of which need not to be written at all. Art deceptivep marketing practices and overprescribing, these drugs have become a default solution for any pain rather than the severe pain for which they were intended. Doctors should appropriately target pain with appropriate and proportionate medicines, moderate measures for moderate pain. Carful opioids for those who really need them. What are we doing to address the lack of effective nonopeio id treatment for chronic pain . I want to thank you for your leadership in this area over these years. I think many of us looking forward to the summit you are bringing us together for in a couple of weeks, i will ask him to talk about the things that are being explored in other areas of pain management. Your leadership in this area that has been very devastating, research in pain exists across multiple institutes of the nih. There is a consortium that is trying to integrate in this. As it relates to the development of new strategies for the management of pain, there are several approaches. Develophem is helping that which cannot be tampered with. Another approach is the not beingt of a based on opioids. There is a third approach that aims to the use of Stimulation Technology that will affect the impulses in nerves and in the brain to control and regulate pain. That relates to tools like magnetic stimulation or electrical directcurrent that allows you to either stimulate or inhibit areas of the brain. There is also research in terms of evaluating behavioral and cognitive intervention that can improve the outcome of patients suffering from chronic pain. There is a wide variety of approaches to try to address the lack of effective interventions that are safe for management of chronic pain. Yesterday, the cdc announced prescribing outlines for opioids. There are 12 recommendations. The bottom line doctors should avoid using powerful opioids as the first line of defense against pain, saying the risks from such drugs far outweigh the benefits for most people. With respect to the dosage, cdc says start low and go slow. Think doctors are likely to follow the recommendations that the cdc has put forward and what steps can we take to get the medical community more engaged in the problem . Guidelinesthe cdc help improve the prescription processes as it relates to the use of medications, particularly for the management of chronic pain. The cdc guidelines were excluding patients who have cancer pain or hospice care pain. The guidelines puts a frame of reference that is based on the current knowledge but also experience. There is not sufficient Scientific Evidence on how to properly use opioids. As a result of that. , and added with the fact there is an increase awareness that current practices of opioids cannot continue the way they are doing now. It is unacceptable. That education on the Health Care System and the public, along with guidelines like the one the cdc will facilitate, the changing of practices of how we prescribe medication for the management of running pain. At the same time, that is the other aspect providing antiquated care for those patients who suffer from chronic pain which can be very devastating. You and the congress and others have fought for years to get the pharmaceutical companies to develop abuse deterrent formulations to make opioids so they cannot be crushed and take away the time release of the drug in just a split second. Fivewe have got i think deterrent opioid pills on the market. Dockets are doctors are not prescribing them. I dont know if they dont know about them or dont care about them, but they are not using what we have developed as an abuse deterrent strategy. What do you think about that . It is likely there are Different Reasons why doctors may not be using them. One that is important for us to be aware of is we have to be certain because it requires the development. They tend to be more expensive than the old opioid medication. We want to be mindful that there are insurances that when a physician prescribes it, the patient will be reimbursed for the cost. We have to create a system that incentivizes utilization of these deterrents that by default will be more expensive. And Insurance Companies are reluctant to pay the increased cost because they say the regular opioids are cheaper and therefore we will cover the lower cost. How can we deal with the payingce companies not for the medication . Scientist. A pure that is above my pay grade. Im way over time here. Can you answer that one quickly . It is a complicated ecosystem you are talking about in terms of what we need to do to educate physicians about their role. I think most physicians, im a physician and the people at our table are focused on delivering the right care. Things take some time to filter down and we need to speed up that process of translating what we know. I think the cdc guidelines are intended to achieve that. Economics, that really comes down to whether Insurance Companies can be talked into this kind of reimbursement if they are given a strong reason. I think we have a stronger case that needs to be made about moving where we have been from drugs that are so abuse prone to things that are safer. If there is any Insurance Company listening, they would be coverage of allow these abuse deterrent drugs because they do want to know what would happen if they dont. Thank you. Thank you, mr. Chairman. We will go to the Ranking Member, the gentlelady from new york. Thank you very much, mr. Chairman. We are with our chairman in this issue. I want to get back to the cancer moonshot because when you look at the numbers and you think of the number of people in this room whose lives have been touched with a loved one who is suffering from cancer, im thrilled that we are focusing on this issue. In 2015, there were nearly 1. 7 million cases of cancer diagnosed in the United States. Im very pleased to see this focus of the president and the nih. Could you provide specific examples of what the cancer moonshot hopes to achieve with Current Research and that Precision Medicine initiative. Moonshot the cancer target cancers that today have been difficult to detect and treat such as Kidney Cancer and pancreatic cancer . Thank you, congressman. We really appreciate. As you point out, not only is the incidents i, but close to 600,000 people in the United States will die this year from cancer. The moonshot is designed to look at many different aspects of cancer and to take advantage of the enormous opportunities that we have in this area. Two areas of focus are not just areas of treatment, but also for prevention and screening. In prevention, looking to develop vaccines not just against targeted material from infectious diseases, but also abnormalities in cancer. We are screening, taking advantage of new technologies such as what dr. Collins mentioned are single cell analysis. Changesake these looking at the blood and other fluids to try to scream for Early Detection of free cancer and cancer. These are just two of the highlights in the moonshot. Thank you. I have a little time left. Estimate i have been very concerned with the numbers in my own district one in 68 children will have an autism spectrum disorder. This is one of the reasons im such a strong supporter of the Brain Initiative which could provide deeper understanding of how the brain works and unlock treatment for autism as well as a host of other disorders. I think all of us appreciate the work you are doing on alzheimers disease as well. Hasou could tell us what the research told us to date about the cause of autism, both in genetics and environmental factors, and how would the fy 7 budget request go towards these research initiatives. Both under the Brain Initiative and other institutes throughout the nih. Thank you for that question because we are enormously excited about what is possible now in terms of research on the human brain. The probably most challenging frontier in all of Biomedical Research. The most complicated structure in the known universe. 86 billion neurons in the brain. Each of those have about 1000 connections. We are just bold enough to think we might be able to understand how the circuits work and do the Amazing Things they do over the course of the next 10 years in a very well laid out blueprint for that research was his guiding the Brain Initiative and in its third year. Thank you to the congress for supporting it. We hope that will continue to be able to ramp up additional funding. Autism is clearly a complex heterogeneous collection. If anybody thought we would come up with this one simple act, that chance is gone by. It seems with careful analysis of dna, looking at the genome information, that something in the neighborhood of 20 to 25 of those with autism and those in the more severe and of the spectrum have genetic changes. It happened for the first time in that child. Not in the parents. It was a mutation that arose. Ver the course of set ofave an interesting features when you look at the genes involved. They are proteins that are active at the synapse. That makes sense that autism is the circumstance where the Communication Systems in the brain are not functioning the normal way. That gives us hope we can begin with a unifying theory about what is happening and begin to develop better ways to introducing new there. Therapeutics. This will be one of the investments in the Brain Initiative which itself is a science effort. It builds a foundation in which we could apply all kinds of other research to understand autism, alzheimers disease, parkinsons disease, brain injuries, drug addiction. All of which have a root in the brains circuit that sometimes do not function the way they should. It is an exciting time for us to push this forward. It has resulted in the recruitment of a really fascinating array of people coming from different is a blueberry perspectives disciplinary perspectives. There was a lot of engineering, neuroscience and nanotechnology. Thank you very much. Thank you. We will next go to my good friend, the gentlelady from connecticut. Last year, we talked about nihs relatively new policy to require applicants to report their plans for the balanced male and female cells in animals in preclinical studies and all future studies. This is an issue we have been working on since we first came to the congress. In our discussion last year, you noted Institute Directors were in the process of finalizing their guidelines for all. Let me note a recent analysis in nature magazine. Article which showed as recently as 2014, only 53 of Research Papers recorded both the sex and age of the animals used in the study. I relies the analysis looks at Research Papers that predate the implementation of nihs policy about sex balancing clinical research. Can you provide an update on an nihs efforts to ensure that Research Includes both male and female animals in preclinical studies and can you update us on nihs efforts to ensure that Preclinical Research include both male and female tissues in primary cells . Thank you for the question. As you can see in the visual i have put up, this is something nih has gotten very interested in. In this article that we wrote in nihsre points out from prospective, you are right. All those that have made this case are right. We have not been taking enough attention as we should to balancing males and females in Preclinical Research. In the process, because many animal experiments, particularly with mice, have focused solely on males. We are missing out on important differences of biological significance that might be things we need to know for human medicine. We are determined to change all of that. I saw the article you mentioned. Im happy to say i dont think you will see that article being written in another year or so. We did in fact put out a notice back in june, but it went in effect on january 25. Doingow on, if you are any experiments involving animals, you need to include males and females. If you have some idea that you are not going to do that, you have to justify that. You can probably get away with sticking just the males if you are studying cancer, but for most other things, it will be important in a condition of the review. That is true with male and female tissues of primary cells . I think that has been a wakeup call. People thought that a cell is just a cell but a cell has a sex to. O. We are losing out on information. That is becoming part of the norm in the way we want to fund research. Thank you. Let me talk about taxpayers provide 30 billion annually for your research. Dr. Collins, you said nih conducts the basic science that ultimately leads to ways to treat complex medical conditions. In so many cases, tax they are funded taxpayerfunded cases go back to the taxpayers at exorbitant prices. Drug to to a and for a treat prostate cancer. It now costs patients 129,000. The same cost patients in other countries a third of that amount. I realized the pharmaceutical Companies Invest the resources, bring in new drugs to market. They should profit from that innovation. I want to know why u. S. Taxpayers are being gouged for drugs that would not exist without the significant investment of u. S. Taxpayers. Can you better explain why u. S. Taxpayers are paying for Biomedical Research and paying exorbitant prices at the backend. I will just say 50 of my colleagues and myself sent a letter to you and secretary havell requesting the nih rights when taxpayerfunded research leads with patented product that is not available to the public on a reasonable term. What are reasonable terms . A drug should not cost 129,000 for people to get access to it. I know this is a topic of great interest. My heart goes out, as all of us do, to patients who are in need of a therapeutic which is outside of the financial means to gain access to. That ought to be the thing that drives us at coming up with better solutions. I will say in regard to rights, we read a letter carefully. You saw the response from secretary burwell. Nih does in fact have the ability to march in if reasonable terms and not being met and if we have intellectual property. What is a reasonable term . That is where it gets down to the nittygritty. We have looked at that situation several times in the past. We have not felt we reached reasonable terms but we are totally open to consider that on a casebycase basis and will be glad to do that with other products that are brought forward. We get it that this is a serious issue. I have got over my time. Thank you. Next, operating on the order of mr. Harris, you are recognized for whatever questions. Thank you very much. Good to see all of you again. It was a great visit last month to see what is going on. Meeting with dr. Rosenberg and the patients reminded me of why went into medicine. What am i doing in politics . Let me ask a couple of questions. First, with regards to the dr. Collins, you mentioned one of the 10 things on your predictions is an hiv vaccine. What is addressed in the Strategic Plan is the nonstatutory set aside for research. When you look at the investment a objective, vaccines or vaccine accounts for less than 400 million out of a total of what i assume is now almost 3 million. Billion. With the additional 2 billion that was appropriated last year, how much of that went into the Vaccine Development . You address the cost if you can bring that down to zero, but the only way to do that is developing a vaccine. You are spending about 15 of the budget on the vaccine for hiv. How muchional moneys, went to vaccines and nonvaccine programs . We have talked about this issue. It has been helpful to have your perspective and that of other members. The Strategic Plan i hope people have seen a copy of this. This is something the Congress Asked us for and we put it forward in a way we thought could be very helpful in defining how we set priorities so please have a look if you have not. What weard to hiv aids, have decided is it is time to focus on the most important priorities to end this epidemic. The vaccine is at the top of the list. There are other things at the top of the list. We have looked at other hiv portfolio this year and identified projects which are going to come back for competing renewal which we dont think fit into the highend priorities. As a result, the dollars that would have gone to renewing those programs is becoming open for competition for things that are high priority. Vaccine is very much on that list. We will in the course of the next couple of weeks announce how we are moving 66 million out of areas that were good science but dont seem to be high priority for hiv aids into areas that are. A substantial fraction of that will go into vaccine preparation. There is a line here. 100 million for basic behavioral and social science research. Honestly, i would honestly see that go into accelerating the development of that hiv vaccine. I just returned from kenya around lake victoria. We have to vaccinate people in the end. Im becoming convinced you have a treatment penetration of only 50 . Until we can vaccinate as with other infectious diseases, we will not hear it cure it. The chairman of the committee left. You mentioned marijuana. Survey by state. You can find charts that look at the increased use of marijuana. It is interesting to look at what happened in colorad between the 2002 to 2003 survey and18 and 25yearolds compared to the 2015 survey. Past month is not just used it once. 31 . Nt from 21 to 18 to 25 by my understanding of the potential adverse effects of marijuana on brain function and development is the worst interval. Maybe not. Even younger years would be bad, but 18 to 25 is a bad interview. The national use went from 17 to 19 . What happened in colorado is you legalized the drug. There is a lot of misinformation about what happened when you legalize the drug. Usehanged from 21 to 31 in a highly vulnerable population of concern to me. Is it of concern to you . I think that is the advocates for legalization say we should not be concerned about the usage figures. Im interested in your opinion. We are very concerned and particularly concerned about the high rate of use of marijuana not just in 18 to 25, with teenagers. Colorado has the highest rate in the whole country of the use of marijuana in that age bracket. We are particularly concerned because marijuana could interfere with the normal formation of synapes, connections between neurons. That process of connection is happening from the moment you were born, even before you were born, until you are in your mid20s. Formation. That when you are smoking marijuana, you are interfering with these very carefully orchestrated process by insurance our Brain Development is the most. We are very concerned specifically of the concern of adverse effects. Thank you ray much. This chair is struggling to enforce the clock even on himself which shows how much interest there is here. I would ask members to try to do the best they can in that regard. I will go to my good friend, the gentleman from pennsylvania. I resemble that remark. I see you sitting there before you came to me. Let me thank dr. Collins. Group working on neuroscience. The National Science foundation cochair. The National Science foundation is on the other side of the capital. These two things are intertwined. That is the science and work at nih. Together, how we are going to make disruptive progress. We also now have, in my other bill, language to create a group on imaging. Is very engaged in this. What im interested in now is i see the numbers for this years budget. If you could talk to the committee for a minute about what the 12 year cost is on the Brain Initiative so that we can see it in totality. I spent some time in stanford with dr. Newsome and some of his people. I think it would be helpful. This is the administrations initiative. In truth, it is a partnership between congress and the administration. I think that we need to make sure we have a good understanding of how the runway is in front of us in terms of what we want to achieve. I appreciate the question because this is an area of great excitement. How we figure out how those circuits in the brain do with a hat they do. That is an mri which shows you the way wiring works in the brain of a healthy individual. New technologies we did not have the ability to do until fairly recently. The Brain Initiative was in fact conceived of as an effort that would result in a lot of Technology Development in order to be able to do these measurements on circuits realtime. The move into applications. The overall budget for this was to ramp up beginning in the first year of 2014 at 46 million and wrapping up to Something Like 400 million a year which we hope to get to. The overall budget, over 12 two 2025,g from 2014 is 4. 5 billion in the proposal that was put together. This was an effort that was led stanford andme of an amazing dream team of neuroscientists who put together this plan over a year and a half ago. That blueprint is out there. It will be revisited as technology develops. We are ahead of our schedule right now. Thank you. Let me say that the chairman and our Ranking Member along with members of the committee, we were pleased with the increased last year. I know the chairman made some comments about the administrations proposal and where we are on that with joining the chairmans view that that is not acceptable. There is some context for a good part of the years we have been in afghanistan. We have spent about 2 billion a week on average. Just as a country, when we think about all the lives that are affected by diseases and disorders you are seeking to increase evenlion though it is very significant, i n perspective, this is a nation that could do more in terms of research and science and medicine. It is just a matter of political will. To make sure that we are clear that the 4 billion is where we have to get to to do the work we need to do. Zika virus t is is there anything we need to be helping you more in that regard . I yield back. Thank you for that question. There is something that congress could do. The president asked for a 1. 8. Illion subsidy to enable us we really do need that money because right now i have already started a Major Program in zika research, particular towards the development of the vaccine. Im doing that with no new funds. That is not going to last very long it is in order to prepare for the next phase of studies that would be the efficacy studies plan to go into a phase one trial for safety by the end of the summer come early fall. We could not take it beyond that if we do not have the money and we need it. Thank you. Now to the gentlelady from alabama for any questions. Thank you. Dr. Collins, as a mother of young children, im very interested in the health of the use of our nation and specifically it has come to my spention that nih has 1. 5 billion on the National Childrens study since 2000. This effort was halted in 2014 based on your recommendation. Nih conducted a shutdown of the children study in 2015 and 2016. Provided, the omnibus 155 million for the childrens study. The president s 2017 budget required levels. In the budget justification, you mentioned nih will use these funds on a new program. The environmental influence is what you are calling it. It is designed to study a wide range of pediatric conditions. The budget recommendation states it is designed to take advantage of existing resources left over from the now defunct children study. What i want to know is can you begin by describing first the results that we gain from the 1. 5 billion that we spent on the entirety of the children study . If you will start there and then i have some all of questions. I appreciate you raising the issue because it has been an area of intense interest. The National Childrens study authorized by the congress 15 years ago, over the course of time, developed a number of features that began to look as if they had not kept up with the Technology Developments. It was painful to look at this a couple of years ago and conclude we needed a different approach, that we did not want to expand the program which had deficiencies. That was the reason, with much advice from experts, that we decided it was time to close down the National Childrens study. There are many samples and Data Available from the individuals that were enrolled in the National Childrens study. It was all Pilot Programs. Those are available to researchers were starting to go through them and see what data can be derived. I think we turned our attention to how we can achieve the same goal of understanding what are the environment to influences on Childrens Health and how can we get those answers now in 2016 in ways we could not have imagined possible 15 years ago . Explain to us how that 1. 5 billion in investment will carry over into echo. What can we take from all of that investment and know that with this additional money, the 165 million that is requested, how could we know that 1. 5 billion is not time and money wasted . It is not in the sense there are pilot efforts that have Research Available that can help us guide what kind of decision we need to make with the new program echo in terms of what Lab Measurements and exposures will be most important. Echo is focused on areas that seem to be particularly compelling based on what we learned through the study of the National Childrens study. Obesity andma, neurodevelopment including autism. That is where we want to go now. It will result in more meaningful data. Andill get there quicker involve more data access opportunities for researchers around the country where good ideas about how they will learn from these. How we can do a better job of keeping our children healthy. The language that was required said you should send a plan on the next phase of the study no later than 90 days. Where are we on that . Can you give us some highlights . We are planning to submit that report a few days late because we are in a very formative place for echo. What we are doing is inviting those who have been running cohorts of children, where they have collected a fair amount of data to join this effort. We will make it possible for them to have Additional Laboratory measures added to what they are already doing and create a whole that is rated of the sum of its parts with maybe 70,000 children whose follow up information we can add further data. That is going to be something we will learn about fairly soon. The applications are due on april 15 for the cohorts to say they are wanted to be a part of it. The process of recruiting a director for this effort, we have an exciting candidate lined up. There will be a lot to report. We are grateful to the congress for your confidence this is something you wanted to continue and provide the resources for. I think although we have gone through a difficult transition, what we are on the path to do is going to be much more successful than five years ago. Thank you. It when i go to my good friend from california. Thank you. I would like to follow up on the questioning of ms. Roby in regards to echo. You areyou said that putting together a 10 year plan. ,hat will include, i assume milestones and funding estimates. The do you expect recommended Advisory Panel with outside experts to be established . Those are highly appropriate questions. At the moment, the plan is for a sevenyear effort. We would want to see how we do in seven years, but expanding to 10 would be the hope if the project is doing well because it should continue to yield new information as we follow these children over time. The Advisory Committee will be formed as a working group. That is important because the echo program involves multiple institutes at nih. The child health institute, others as well. We need to have this position in the place where we have advice from experts across many different disciplines. That is where our council of counsel comes in and that is where we will position the echo. The congressional justification mentions six Research Activities for which funds were directed in 2015. Are these the existing cohorts that will be used Going Forward or are used to identify cohorts to include in the echo initiative . One more question because of time will be array of cohorts include broad population samples and measures that are specifically designed to compare knowtudy cohorts to National Samples like the National Health and Nutrition Examination survey . In terms of what cohorts will be involved, this was best handled with competition so we put out a funding opportunity announcement and waiting for april 15 to come when we see who applies. We expect many of these cohorts to be very interested in taking part because it gives a chance for their work to be more meaningful. We want to see that happen. We want to take full advantage of the National Study that has much needed in it of National Health andd major nutrition to do comparisons with what we see with cohorts. It is wonderful we have that kind of foundation to do this with. One other aspect of echo that deserves mention is an effort to set up in the idea state, the states that do not have a Research Intensive University setting, a Pediatric Research network. There are so many things we could be doing in terms of pediatrics. Clinical research in those states that we are not currently set up to do so. This is a proposal to build upon the expertise that is happening in those idea states to create a Pediatric Research network and enhance our ability to understand what are the influences in Childrens Health we dont know about yet. One final question in this area. Justificationonal states it will be assessed starting in 2017 and that this could drive the future direction significantly. When will that assessment begin and who will be involved in doing it . We will count on our eyes regroup that is being put together. In 2017, we will have cohorts funded and assembled together. Will be a coordinating center to make sure this is all working in the most effective and comprehensive way. 2017 will be the point in which we have an assessment to see whether this model is working and producing the data we believe it should. Thank you. Next, the gentleman from tennessee. Thank you very much. It is truly a privilege to be on this committee. When we see what the nih and related agencies are doing, it is tremendous we see the great cooperation and efforts made in this critical subcommittee. Youcollins, let me thank and your distinguished panel again. Your efforts in combating the maladies that face us on the health front are difficult. Again, thank you for your successes and your continued efforts. I have got a threepart question which i will read through in the interest of time. Dr. Collins, but to take a moment to address the Precision Medicine initiative. The first question is regarding the direct volunteer portion of the research cohort. As you know, Vanderbilt University is playing a leading role in the direct volunteer portion of the research cohort. Can you elaborate further on how the Pilot Program will inform the initiatives Going Forward . The second part of my question is regarding the approaches nih is using to recruiting and retaining people in the pmi. Im pleased to see nih adopt practices, including the use of social media to attract volunteers, i would like for you to address some concerns that have been presented to me by the scientific community. Specifically, can you address nihs glanced to interpret and understand the biases, given that many people do not use social media and all. Finally, is the nih working with partners thather conduct large surveys to understand the biases in the pmi million person covert. Great trio of questions. Let me answer quickly because i know we are under a time constraint. The initiative is getting launched this year. Many of us a working 20 47 to get this up and going. We are very excited about the potential. The goal is to enroll one million americans by 2019 in a full participant that will conduct information from them. There are reports of medical experiences and allow was to understand what are the factors involved. We never had anything like this before anybody who with heard about it is pretty excited about the kind of inferences we can learn. Vanderbilt is right out of the block and major part of the first launch here because they just received an award in partnership with google which is now called verily to set up the effort to do a pilot effort to recruit direct volunteers. I say pilot intentionally because we need to learn more about how to do this. Their concerns about social media being a biased way of involving people. It has been apparent to us and we dont want to depend solely on that. At the same time with a partner like google and entered a working together, we believe we should be able to learn more about what it is the volunteers are interested in, what makes it appealing to them to join this effort. We want to get this really clear. We have two different ways that people can come into this. One is by direct volunteer route which will be open to any american. We are asking those Health Provider organizations that are already running large cohorts to come in as our partners because they already have lots of access to patients and lots of information about them. That will be a substantial part of the effort and not depend on any social media concerns. If they decide to consent, they will be participants in this historic undertaking. We are reaching out to the traditionally underrepresented groups by working through Community Health centers with our partners to ensure those individuals have a chance to take part. Certainly, we are very interested in working with nchs as we get into this to be sure the kind of data we collect is going to be generalized for the population. We dont want a set of individuals that are so different than the population at large that we cannot do that generalizing. That will be important to talk about with those experts at n chs. I am pretty excited about this. This is something many of us have dreamed about for more than a decade. We really appreciate the congresss support in getting this started this year and the appreciation for the consideration of expanding it even further next year. Thank you. Looks like my time is expired. We will go to my good friend from pennsylvania, mr. Dent. Thank you, mr. Chairman. Thank you for having us at the nih a few weeks ago. Really enjoyed that opportunity. I have been very involved in working in the fight against cancer, including encouraging screening for Colorectal Cancer. You will see a lot of the folks in the hill today. Is pursuing a new Cancer Research to prevent, diagnose and treat. What are some promising areas in Cancer Research . I will turn to my colleague, the acting director of nci, to answer your question. As you probably are aware, marchers Colorectal Cancer awareness month. Parts of the Vice President s Moonshot Initiative involves screening which you are involved in to try to use molecular analysis in fluids for making this more realistic so that we can have higher uptake of Colorectal Cancer screening. One of the big problems is that many people dont follow the screening guidelines and it is really important to try to implement what we already know works while we are also doing testsch to develop better and more specific tests. I can report to you that the incidence of ola rector cancel is goingctal cancer down as a result of the screenings we have today. Also the issue of superbugs. What is the latest information on how nih is working with the cdc in treating and curing these antibiotic resistant bacteria and what investments have been made in these efforts . Thank you for that question. The nih is part of a multiagency approach towards the addressing of the problem of Antimicrobial Resistance which comes right from the top, from the white house, which had an executive order and a combating Antimicrobial Resistance Bacteria Initiative of which the nih is a major part. The cdc is involved predominantly in surveillance and detection and providing the guidelines of the use of antibiotics. The nih component is the Research Component of that. In that regard, we are responsible for determining at the molecular level the basis of the emergence of resistance, number one. Number two, to do early screening for new types of antibiotics. Thee has been recently antibiotic which is one that will open up the door to a new class of antibiotic that are not resistant to any microorganisms, particularly resistance. In addition, we have a Clinical Network which we have tacked onto the Clinical Networks that we build years ago for hiv to test promising compounds. The most important issue about all of this is diagnosis. In order to really circumvent of concept the issue Antimicrobial Resistance, you need to make the diagnosis right on the spot. We have been working on very sensitive points of care diagnoses not only to determine if you have a viral infection versus a bacterial infection, because those are the biggest offenders, the prescribing of antibiotics for a disease that is that even a bacterial disease. That is one of the things we have been working on. In a particular point of care to find out what the resistance profile is. That is a rather comprehensive program. We are part of the program of the prize. We have a 20 million prize that we is sharing 10 million of advancementmedical in order to develop a sensitive diagnostic to do what i said. Thank you for that. I want to mention in my remaining time, i know the nih request of mandatory spending has been raised. We are concerned about it and am concerned there is a decrease in discretionary funding at nih and an increase in mandatory funding which is going to be problematic. Last year, we did the 2 billion increase in discretionary funding. This will create a funding cliff or nih. I will nih be impacted if the authorizes do not act to provide mandatory funding . It would be pretty devastating if we were to lose 1 billion. The question at the outset of the hearing i painted a picture and it was not just because i was feeling gloomy. It would be in fact devastating. We would lose 1000 grants which would have been supported. It would have done terrible damage to the momentum that has been started thanks to the congress. It would be a terrible step in direction, comparable to the sequester in terms of our. You knew i would like that question. Very smart. Anything to suck up to the chairman. Lets go to my good friend from idaho, mr. Simpson. Thank you for being here today and thank you for hosting us out to the nih and couple of weeks ago. I have been there several times over the years and i come back both amazed and inspired. To make me feel guilty for having you come here to testify because you have more important things to do than testify before this committee. Getting out what you do and what nih does is part of what is necessary. As we took a tour, you took us around and visited some patients. A young man and his wife. The young men had melanoma. You talked to us about the treatment that he was getting and so forth and so on, and what you were trying to accomplish. I cannot remember which member it was, but somebody asked a Pretty Simple question that i would like you to respond to for the record. What did the government shut down due to you . Most people see it visibly as you didnt get into the National Park or Something Like that. Ok, go next week. It is not lifethreatening. What did the Government Shutdown for 16 days due to you and what happens if that occurs again, regardless of whose fault it is . We can argue that from now until the cows come home. I have been at nih for 23 years. Those 16 days were just about the darkest i can recall ever going through. Where graduates students and postdoctoral fellows and other remarkably scientists were working were all dark. We had to tell everybody to go home. They were under threat of criminal prosecution if they came onto the campus. Experiments that were set up that needed to go for several weeks were basically ruined and had to be started all over again later on, if they got started all. Our clinical center, the Largest Research hospital in the world, very much affected by this. We were allowed to continue the care of patients that were already ther bute we were not allowed to admit any new patients during those 16 days. Those were people who planned to come to nih, the last chance many of them. We are the house of hope for people were medical research is needed because we answer what afflicts them in week had to turn them away. I personally had to oversee that. The only exception was people who were in imminent danger of death and we were able to have a few a day with very high level of approval to do that. People cannot understand this. How could this be that some like this could happen . I appreciate you asking the question. I hope and pray we never go back to that situation again. It was very hard to preside over that kind of dark 16 days and feel good about the government. I appreciate that answer because it is a real effects of what happened that people do not see. As i said, they can see the obvious. Vernon andto mount stuck with the parks service. That dont really think about the lifethreatening implications of some of these decisions that we make too lightheartedly. I appreciate that answer. I can ask about all the other stuff you have going on but im not smart enough to ask it. I appreciate this Strategic Plan you have given. I encourage members to look at the last page. A few bold predictions for americas future. You think of the work that is being done at nih. It is the best kept secret in america. That is good news and bad news. We have to get the American People to understand what goes on at nih. It is done and funded by the taxpayers so that they know what they are getting in return for the investments they are making. We are politicians. We respond to the public and when there is public demand that we investment, that is when it happens. I appreciate you being here today. Im sorry i wasted your time. Thank you. I dont think my friend wasted anybodys time. I think that is something that needed to be heard. With the consent of the committee, we will move to three minutes so we can try to get as many people as possible an opportunity to go, but not before he gives his full five. You actually finish out the first order of business. The second round, we moved to three minutes but you get five. Thank you. I regret i was not able to be here at the start. I was at another hearing. Thank you for being here. We really appreciate the good work you do. I have a little window, and address going old, because my two parents are still doing well at 93 and 88. I speak to them every week. There is a set part because they will generally take me through some of my childhood friends parents that i knew growing up and they will kind of walk through that so many of them have alzheimers. I knew them growing up. That is just my little window into this profound challenge. We have done a good job generally of linking the quality of life side which is lagging a bit. It relates to alzheimers i dont have the quantitative data that i want now. Im working in that direction. Weve increased the funding sharply on a bipartisan basis which i think is a real win. I wonder and i wrestled with this even though we are in a great physical fiscal stress and that has my full attention, it seems to me that this ntsticular area warra sharply increased funding. This is a Major National priority for a host of reasons. Some of them are economic. Just the fact we can get a hold of this. When you comment on that. In auch funding could we, Perfect World if you could have more at some point, you get diminishing return. You have not had that problem yet. How much do you think you could absorb and really leverage the dollar and get the most out of it . Lead to answerur your question. Thank you for the question. It is true that just about everyone has had their lives touched by loved ones, family members who suffer from alzheimers disease. It is the Great Success of the biomedical enterprise with increasing lifespan. The projections are there will be more and more of this. It is an area among many you have heard about today that is in dire need of further research and support. In terms of the very direct question about given the level of funding, it is a critical question. It is not enough to have an urgent Public Health imperative, we need to have functions behind it. One of the opportunities to test that is the congressional request or requirement of nih to deliver the bypass budgeting year which asks us to estimate increased funding that would be needed to maximally pursue an efficient spending in support of research towards the goal. We have taken this very seriously. When we compose that bypass budget was released last july for the 2017 budget, we begin convening experts. A summit of several hundred experts to tell us what the opportunities were, the priorities were. We translated at into milestones. This was the real scientific estimate of what we could accomplish with the level of funding is an increment to be used in 2017. We knew when that budget was submitted there was the possibility of accelerated funding could come in 2016 but we were not sure. Thank you that that money was brought. That money allowed us to carry out the very thoughtful plan accelerating what we propose could be increased funding in 2017 and using it in 2016. In july of this year, we will be thearding on behalf of nih 2018 bypass budget which calls for us to do what you are asking to account for what level of research can be done to accomplish to ensure we can have research is supported officially without compromising quality with the resources available. There is i have about 20 seconds left there is, im sensing, a true recognition that not to the exclusion of other diseases and other things that are afflicting us in our human journey, this particular challenge is getting increased recognition which is one that needs to be addressed. I think we are not limited to ideas about interventions that might be successful. We are not limited by talent of scientists all the way from basic to clinical who are really fired up about tackling this disease. Resources are in fact much appreciated and we have nowhere near the point but were know what to do with it. The bypass budget is a great way to see if resources were available, what could we do . Because go faster. The cost of this economically is over 2 billion every year. Thank you all. Thank you. Weibel moved to three minutes we will move to three minutes. It is helpful to this committee to have access to that kind of data in our decisionmaking last year so i encourage you to continue that. As you know, dr. Collins, i have a particular interest in native american issues. Quickly, i know you look at particular populations and not everybody is the same obviously. There are gender, racial differences. Can you give us an update on what the nih is doing specifically to address native American Health issues . We are very concerned about populations in the u. S. American indians are a special group in terms of their history, their culture and their tribal sovereignty which has a major effect in terms of participation and research that we need to be very respect all of and we aim to do that in every way. Thanks tost at nih, the leadership of my principal deputy, initiated a Tribal Council Advisory Committee bringing representations of the American Indian community to nih to listen carefully about what they see is the priorities we should be focused on and to have a chance to engage with them in topics like the Precision Medicine initiative. Their sensitivities about what kind of information is being derived about ancestry and what kind of access to the information will be provided to people outside of the community. There has been experiences in the past that American Indian committees have gone through that causes them to be somewhat less than completely confident that researchers are always working in the best interest. We really need to understand that. In that context, i think we do have a number of important programs that have been ongoing for a while. There is a strong effort looking indiant disease in country that is being conducted by the institute. The particular project we are supporting is dealing with highrisk pregnancies in native american communities, particularly providing resources to women who were about to maintain the situation that would result in a good outcome with a very impressive outcome process beingular implemented across many tribes. We are looking for ways that we can do research that is acceptable and embraced by the community with very sensitive to the special nature of those concerns in those communities. Thank you for that. We appreciate it very much. In the interest of time, i will move to my good friend, the Ranking Member of the full committee. I will talk very quickly. First of all, i want to say your seven years of service have left an indelible mark. I hope you continue your work because we really appreciate you. Thank you. Secondly, even the lab rats were all a male have been great laugh getter at cocktail parties but it is getting very serious. Harrissappreciate dr. Comments. I dont think the majority of people in this country understand the serious impact of marijuana on the brain 12 to 18, 18 to 25. I do hope you can be aggressive in getting this message out and i thank you, dr. Harris. Lastly, my friend dr. Fauci, the zika vaccine. This. W the seriousness of i wonder if there are any seconds left whether the zika vaccine which all come from mosquitoes, same areas, will certainly have been effective on that. Thank you for the question. Oneave a vaccine for it, that has been approved in mexico and the philippines and brazil. It is not as effective as we would have liked it. It is 67 effective. The nih started a phase three trial in brazil in association with the institute. We have a phase one good vaccine that is safe and that induces a good response. We have had trouble, with the dont think will add more trouble coming getting pharmaceutical partners to come in with us to the advanced development. I think the zika outbreak has shook the cages because we are having pharmaceutical partners were interested. , that isly,zika the advantage we have. Although there are always challenges in the development of a vaccine, we desperately need a zika vaccine fundamentally to protect pregnant women. Those of the most honorable vulnerable, it is a disturbing percentage of fetal abnormalities. We will start a phase one trial likely in september of 2016 based on the expertise that we have developed literally over a decade or more in working with vaccines that are really want to thank you and the committee for supporting the work you have been doing in our ability to respond rapidly to emerging infectious diseases. That is exactly what we have done. We have about six candidates that are in queue. We had a meeting three or four days ago with the fda to plot out the phase one trial i started that would start in september and transition into a phase two, likely by the beginning of 2017. How fast we get an answer will depend on two things. B,i will effective it is and how much infection there is. Paradoxically, if there is a big outbreak in 2017, we would get an answer much quickly. If things die down, it would be good for the Public Health, it may take longer to get an answer. We are very much on top of the Vaccine Development. I just want to say i appreciate your leadership in our Ranking Member and the whole committee in getting the extra 2 billion. I appreciate this extraordinary panel and all the work you are doing. I look forward to working with you so we can say the chairman of this committee has doubled once again in a bipartisan way money for the National Institutes of health. I cannot frankly think of a more important investment. Thank you so much for all the really important work you do and your leadership. Lets do it, mr. Chairman. We will go down in history. For myyou advocating budget or just pressuring me . [laughter] a little bit of both. We will go to my good friend mr. Simpson. We have the three minute limit. They already started timing and i barely got. The cancer moon shot the president announced, which i think was great. Republicans do not always criticize everything the president does. I think this is a good start. It is government wide. I chair the energy and Water Development subcommittee. The department of energy will have a role. They are getting more involved in biological sciences. When i asked him about it, they say we were originally involved cesthe biological scien because of radiation, the cancer caused by radiation from Weapons Development and other things over the years. What is the relationship between nih, the department of energy what are we looking at in the future . What will be the relationship . There is a task force at the highest level which is pointed to support this effort across government with the Vice President s leadership. That very much includes the department of energy as well as fda, nih. And anput from nsf variety of other parts of the government that are involved including commerce. We can tell you something about a direct involvement that is already going between the doe and cancer institute. Could you also talk a little isotopes the medical with the canadian reactor shutting down . We will have access to the medical isotopes that are necessary. Thank you, dr. Simpson. With regard to the department of energy, we have initiated very recently three pilot projects with them in Cancer Research. Of thell form a key part moon shot. We are continuing to have ongoing extended discussions with people from the department of energy, including secretary moniz about extending this. Largely, they have extraordinary Computing Power and Machine Learning which is able to do things that really can be helpful in the Cancer Research area. Given the time, let me get back to you for the record in terms of the isotope issue. Thank you. With that, we will go to the Ranking Member of the subcommittee. I will talk on antibiotic research. I just came to a hearing. 70 of antibiotics sold in the u. S. Are bought for livestock production. There is industry guidance that is voluntary to the fda. I dont know what kind of collaboration you have with usda, with fda, but it is critical. We should not be in siols. You talk about 23,000 deaths. If you know what is going on, lets look at how we can cut that number in half. Last year, but we could do. Andruly is unbelievable voluntary. We need to think about that voluntary guidance. Sell think about how we people and the pharmaceutical companies in a mandatory way. Let me move to the Precision Medicine initiative. I will cut to the chase. I was alarmed by a New York Times article that raised concerns about the lack of success in utilizing genetic testing to it in a five personal treatments for Breast Cancer patients. What is the clarity on this issue and guidance to practicing Breast Cancer patients were physicians . I think this area really exemplifies both the strengths and limitations that we have of any clinical tests. You do a clinical test and for some people, it is enormously helpful and for other people the results are ambiguous. Haveenetic test that we can be enormously helpful in pointing people with cancer in the right direction in terms of treatment. Of it accurate in terms the success has been in other areas other than Breast Cancer. Specifict cancer a disease and not responding to pmi or is this article off base . Help us. There have been specific inhibitors. For example, the first targeted inhibitor was specifically for Breast Cancer and egf receptor inhibitors. That when youlem get an abnormality, not all of them are clearly actionable and not all of them will be responsive. I would like to continue this conversation. I might ask you to take a look at wall street journal this week. Goesolmyers against prescription medicine. I want you to take a look at it and semiwhat they are talking about as we are trying to move in this direction. I have four seconds left. I want toy is make sure any vaccine we deal with for zika is going to be available and affordable for people. It is reasonable. Secondly, i would offer my view. I think it is critical for us to deal with the supplemental emergency resources in order to address this issue and this problem. You are right. I will tell you that we are now sending blood products to puerto rico in response to a zika outbreak. What happens when we are looking that isod supply potentially going to be difficult or people are not going to understand the safety of the blood supply with regard to zika and what kind of problem that will cause in the u. S. . American women are not they are going to be outraged if we are not doing something about them and about their ability to be pregnant and bring a child to term. Thank you for the great work you are doing. I have another question but that is ok. [laughter] mosquitoes modified of alaska the gentlelady to take that one for the record. I want to make sure our remaining members get an opportunity. You will recognize for three minutes. Let me follow up a little bit because the marijuana use and full legalization is a major issue. It affects the district of columbia on our appropriations bill usually. You were coauthor of a 2015 review article. A procedures medical journal. Theme review some of statistics in it and confirm these are still true. With regard to marijuana addiction, even though the overall rate is 9 , if you look at young users or daily users, it is higher than 17 . Is that still true . Marijuana dependence can be much higher. Depending on other factors as well, it can be 20 for general use. With regard to the gateway theory, because this is continually controversial, my best understanding is there is some reason to believe from other studies and models that potentially there is a gateway, but it is still not clear whether that is true in humans. Is that true . Are we developing an understanding it is a gateway drug to other addictive behavior . There is evidence that yes, marijuana can change the sensitivity of the brain to other drugs which can provide a means in becoming more affordable vulnerable. The issue in humans, it is still being investigated. It is not settled science and not a gateway drug in humans. Proceedsa drug that with addiction to other drugs. I did Animal Research so i understand you cannot always extrapolate to humans. Finally which was interesting to me when you look at the effect of schoolaged children and not careful with how you control the criticalt impairs cognitive function for days after years. Is that a fact . That has been replicated by independence. If you allow children in schools to access to it, that critical cognitive functioning can be impaired for days. This is in the setting where we want to actually have children go to school and learn and be content to delete functional. Cognitively functional. Would you urge jurisdictions that are looking into fully legalizing marijuana to exert extreme caution in taking that position at this point . I basically ask people to look at what the data is telling us. We have seen consistently that the effects of drugs in our country are from the legal drugs, not illegal. Not because they are more dangerous but if they are legal, it is more available and likely to expose many more people and explain why we have so many adverse effects. I will be say you want to have a third legal drug. Can we as a nation afford it . Now for the last question of the day, we go to our good friend from california. And i haveague recently started a congressional caucus on Maternity Care to promote optimal birth outcomes for women and to highlight issues like the zika virus with risk to childbearing women. We have been following with great interest the World Health Organizations finding and counsel regarding this disease. The committee stressed the urgency for research and development of the zika virus which you have talked about earlier. The Committee Also recommended both retrospective and prospective studies of the rates of microcephaly and other narrow logical disorders in neurological disorders, where such clusters have not been observed. My question is whether or not it is possible bazooka virus has been responsible for possible the zika virus has been responsible for microcephaly over the past three to four decades and has there ever been any tracking of the birth defects to see if there have been clusters or increased incidences in the u. S. . Not with regard to the retrospective studies. There has been no zika virus in the United States. We knew that when we do scannings of what has been in the United States. There has been no zika virus in the u. S. Until it arrived in south america and the caribbean. What we have now in the United States is over 190 cases that have been imported. Mostly people that have been in the caribbean and south america that were affected there and came back home to the u. S. When we have not had his local outbreaks similar to what we did see a few years ago with florida and texas and with chikungunya in florida. There is a very important surveillance capability that will give us a negative answer to your question. We had not zika virus in the u. S. , but it will also tell us if and when unfortunately, it is probably likely we will probably see many local outbreaks particularly in the southeastern part, gold coast states, texas, florida, etc. Because the mosquito, the major transmitter, is in that area of the country similar to puerto rico and south america. Finally, what we do have in south america are cohort studies to take a look at what the fundamental baseline level of microcephaly is and what the relationship is to the infected people of zika. Two studies came out one came out a week ago showing if you look at zika infected women who are pregnant and pregnant women who were not infected with zika in brazil, there was a very disturbing 29 of the zika infected women had ultrasound indicating abnormalities of the fetus which is very deserving. That is the reason why we feel compelled to be able to get a vaccine to protect not only the people in south america and the caribbean, but if it is necessary that it comes to that in the u. S. My personal interest in this particular area my grandson was born with microcephaly. This had to be probably over 12 years ago. As a result of that, both my daughter in law and my son took every test imaginable to find out what the cause was, especially since they planned on having other children. They can find nothing, none of that research. We are trying to figure out what possibly could have been the cause. There are a number of causes. A very important question because some people get the misimpression that microcephaly is only associated with zika because of the publicity. Microcephaly has been around forever and it is associated with something that happens usually in the first trimester. That can be a viral infection. It can be any of a number of viral infections. Can be fetal alcohol syndrome. A friday of things that interfere with a variety which takes place concentrated in the first 15 to 20 weeks of pregnancy. Although, we do know from the study that even women who get infected in the second and early third trimester could have abnormalities in the fetus. It may not be microcephaly but the range of abnormalities is disturbing which gives us fuel to the fire of having to get that vaccine. The other cause to mention is genetics. It was hard to nail that down. Now that we have the ability to look at the complete genome sequence in a situation like that, we are uncovering causes of microcephaly that are due to dna changes that we previously did not know about. That is wonderful. Much, dr. Ou very collins. Let me begin by thanking you and your colleagues for not only your appearance today, but obviously your excess ability to all of us when we have questions. I appreciate the wonderful work you do. We will have plenty of opportunities, but this may be your last appearance before this committee. That would be the decision of the new president at some point. We hope it is not your last appearance speaking for myself personally. I want to thank you for the Exceptional Leadership that you have shown at the nih for a lifetime. That would go to all of you, putting the health and security of our people but all people as your principal goal in life. It is a quite remarkable achievement. You are very distinguished in your own field. To see the manner in which you collaborate together and work across disciplinary lines and institutional lines is very inspiring. We appreciate the values you show and the basic and decent humanity that each of you exhibit. It is of no surprise to me that it is the nih that tends to bring this committee together, where it puts aside partisan differences, ideological differences and really does try to work in common to advance and support the splendid work you are doing. I am sure that will continue. We will have other things we will fight about but this not going to be one of them. This is going to be one of the areas we Work Together. Where we protect the decision discretionary funding you got last year due to the bipartisan efforts on this committee. We try to build on that and hopefully we can go to the question i asked you in the first round and that will perhaps do better than even the president proposed. If we can go beyond that and put additional means your hand, i know we will want to do that. Thank you and we are adjourned. Thank you. [captions Copyright National cable satellite corp. 2015] [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. Visit ncicap. Org] every weekend on American History tv on cspan3, feature programs that tell the american story. Some of the highlights for this weekend include this evening at 8 p. M. Eastern on lectures and history, Dickinson College professor David Oconnell discusses president ial legacies and the factors that contribute to a successful president ial term. In10 00 p. M. On railamerica, september 1963, president kennedy traveled across the United States to promote conservation of Natural Resources for future generations. Sunday morning at 10 00 on road to the white house rewind, a 1984 democratic debate in atlanta includes former Vice President walter mondale, senators gary hart of colorado and john glenn of ohio, George Mcgovern and reverend jesse jackson. For a complete schedule, go to cspan. Org