1965, john wilkes booth shot lincoln as he sat with his wife mary mary, watching the play, our american cousin. the president, bullet still lodged, was carried across the street to the peterson house where he died the next morning. we'll look back on that night with events from a ceremony honor ing honoring that anniversary tonight at 8:00 eastern on cspan 3. dr. francis collins recently testified on capitol hill before the senate health education labor and pen gens committee. that initiative funded through the 2016 budget is a research effort designed to improve treatment for diseases like cancer and leukemia by tayloring health care, not a one sized fits all approach.

>> this morning we're holding hearing on continuing america's leadership realizing the promise of precision medicine. we'll have an opening statement then introduce our witnesses, who are getting to be very familiar to us. we're very grateful to you for coming. after that, we will have time to ask five minute rounds of questions or two, depending how many senators are here. we are here today to discuss exciting new direction in our health care called precision medicine. what does that mean? well, those of us in the room a good representation of the population, they estimate one in ten of us would have diabetes. if doctors could use precision medicine, that is if they could look at our individual dna and genetic, molecular makeup of disease, perhaps they could tailor treatments to each

individual rather than to more general category of diabetes. i was visited this morning by the head of philadelphia children's hospital who talked about their work in identifying a defective gene, mutated genetic defect that causes blindness, and how they have developed a therapy that restores the sight in a child because of the therapy directed for that specific genetic defect. this is happening with cancer treatment. doctors can look at the cancer cell and assess how to treat it. news week reports genetic testing on tumors is starting to become the norm in the big cancer hospitals, like sloan kettering, all incoming patients have their tumors sequenced. this is all possible because of extraordinary achievement by a great many individuals on sequencing the human genome,

none more important than dr. collins who is here today. we are grateful for that. today we want to discuss what national institutes of health and private industry are doing in precision medicine, how the food and drug administration will regulate those innovations, how electronic health records can effect the ability to innovate and what this means for the american patient in the health care system. it is one of the most exciting new frontiers in medicine. senator murray and i are working on initiative to ensure our federal agencies are equipped to review medical products and processes produced by this kind of cutting edge medicine so american patients aren't waiting on the sidelines because regulatory science can't keep up. our innovation initiative is not just about precision medicine but precision medicine is an

important part of our initiative. president obama announced a precision medicine initiative in the state of the union this year, he detailed his plans at the white house and i attended that to demonstrate my support. the president proposed mapping gee gnomes of 100 individuals and making it available to medical researchers across the country. look forward to hearing more from our witnesses. there are similar private efforts under way. i am interested in hearing about that competition and about possible collaboration, for example, children's hospital of philadelphia that i mentioned has 250,000 individual children genomes sequenced there. i wonder how useful that would be to the one million dr. collins is putting together, how these scientific entrepreneurs, dr. ventner in california, philadelphia, other places, how that relates to the president's

proposal for a million individuals. i look forward to hearing the cost. the cost to the human genome have been reduced in the last two decades. dr. collins testified i believe that he said 15 years ago would cost about 400 million to sequence the first human genome, whereas today it is about $1,000. very often in health care innovation initially increases costs, doesn't mean we shouldn't innovate. they can increase costs but in the long term decrease health care costs. take alzheimer's which according to alzheimer's association will cost $226 billion this year, along with other dementia. we could use precision medicine to delay onset or cure of the disease. save precious dollars in health care systems and alleviate some grief and pain associated with it. the committee has spent time and will spend more on improving electronic health records. the federal government has spent $28 billion to drive the adoption of these record systems and the results is that doctors

don't like the systems. they interrupt the doctor-patient relationship and haven't been worth the effort. senator murray and i begun a working group to identify the five or six thing we can do to help make the failed promise of electronic records that something that physicians and providers look guard to. instead of something nay ensure. dr. desalvo, we look forward to working with you on that. and looking forward to results that you take administratively or we do legislatively. we have to get to a place where the systems can talk to one another and smaller physician's offices want to adopt the systems, can't afford the cost, can be confident their investment will be of value. dr. collins told us that a properly functioning electronic medical records system is tremendously important to the

president's precision medicine initiative. it can help to assemble the genomes of the one million individuals. and second if we want to make genetic information useful, this is complex stuff. it's going to take computers that operate easily and with a click of the house to help make it possible for doctors to actually prescribe prescriptions for individual patients. also would like to hear if we know dr. desalvo, at some point, how the $11 billion effort by the defense department on electronic medical records would relate to the $28 billion we've already spent, and whether those will be compatible and whether you'll be working with them. there's a lot to talk about today. this is a tremendously interesting and important effort. and i look guard to the

witnesses' comments. senator murray. >> thank you very much, mr. chairman and thank you to the witnesses for being here today. each of your agencies plays a critical role in the topic we're talking about and i'm grateful to have you here to share your expertise. i've approached our bipartisan effort to advance medical innovation focused on one question in particular, and that is what can congress do to help all patients and families get the safest most effective treatments and cure more quickly. our conversation today is about the promise of precision medicine and it's a crucial and truly exciting piece of the puzzle. there's in question we're at a critical moment in the medical field. researchers and medical experts are increasingly finding ways to treat patient, not just as the average patient but instead based on their own unique characteristics and history.

this is the different in getting eyeglasses based on the average prescription and getting eyeglasses based on your own prescription. it's huge, especially for families across the country waiting and hoping for better cures. i'm proud that nay home state of washington is home to several institutions that have been pioneer in this area, the university of washington, which is using this precision medicine technology to tackle breast cancer, eye disease and alzheimer's disease. i'm glad we have to opportunity today to discuss the ways in which precision medicine is changing and improving lives and how congress with help advance the new frontier. the president has proposed making significant investments in precision medicine. his physical year 2016 budget has a budget to advance the genomics and data management to shift away from the one size fits all medicine to treat

tailored to specific individuals. this proposal could accelerate the advancement of precision medicine. as i discussed with dr. collins last week, i'm deeply troubled with the nih's purchasing power. they were able to come together to replace the harmful sequestration cuts to nih and fda and other critical priorities like education, infrastructure and defense. i'm am hopeful that we will be able to work across the aisle and find a way to prevent these short sided cuts in kicking in again. this is absolutely critical to the kinds of investments we need to keep our -- make our families -- to help our families and grow our economy, including precision medicine. one of my top priorities on this committee is to look for ways to continue improving the quality

of care patients receive and supporting precision medicine is essential to that goal. by offering patients and provider misare and much better health information, patients in consultation with their doctors will be empowered to make informed decisions about their care. and our health care system will be better equipped to put their needs first. protecting privacy will be an important challenge throughout this process. in the last few months we've seen serious security breaches impacting families' health information. that is unacceptable. as researchers, providers and patients gather together, we need to be aware that data is being created that cyber criminals will want to exploit. that means we'll need to develop strategy to protect privacy that meet today's challenges.

chairman alexander and i are investigating the current state of cybersecurity in the health sector and this needs to be an all hands on deck effort with providers, insurance and government working together. thank you to all of our witnesses for being here today and i want to thank chairman alexander for holding this meeting. and i look forward to working together with you, mr. chairman, and other members of the committee to support this important initiatives. >> thanks, senator murray. to the underscore what senator murray said, this specific topic is an issue with the president which the committee in a bipartisan way is interested. we have three witnesses and i'll ask senator cassidy if he would like to introduce the first one. >> yeah. dr. karen desalvo and i know

each other from way back when i was full time with lsu and she with tulane. i told her that we made the spread tulane green today. she's at the office of the national coordinator of health information technology. onc is the lead agency charged with formulating the federal government's i.t. strategy. i've been impressed. dr. desalvo has come to me personally. there's a friend back home who's having a lot of problems with her medical record and adapting to it. she clearly recognizes interop ability is key. she's listening to the physicians and developers of this product. he was a health commissioner for the city of new orleans, including and after hurricane katrina. >> we look forward to you testimony. we expect to get to know you

pretty well here because all of us are interested in fixing the electronic medical records system. and you're on the point for that according to secretary burwell. we look guard to that. our other two witnesses, dr. collins, the director of the national institutes of health who oversees the work of the largest supporter of biomedical research in the world. he's been the director since 2009. and of course he's known among other things for his leadership of the international human genome project. completely sequencing the human genome in 2003. dr. jeff shuren was here last week. he's at the food and drug administration for more than five years. they're responsible for sharing the safety, effectiveness and quality of medical devices, and fostering device innovation. we welcome him back. if the witnesses would summarize their remarks in about five minutes, we would appreciate it.

we have senators here who want to have a conversation with you. so let's start with dr. collins. >> well, good afternoon, chairman alexander, ranking member murray and distinguished committee members. it's an honor to appear before you to discuss how we can advanced americans' health. earlier this year the administration unveiled the precision medicine effort, a bold new initiative. we believe the time is right for this ambitious initiative and the nih and our partners will work hard to achieve the initiative. we've had to make decisions based on the expected response of the patient. this one size fits all works for some patients in some conditions

but not e others. precision medicine takes into account individual differences in patient's genes, lifestyles. blood typing, for example with has been used to guide blood transfusions for almost a century. the identification of the brca one and 2 genes has made it possible to provide options for women at high risk of breast or ovarian cancer. and the gene discovered in my own laboratory 25 years ago has led to wide spread ability of targeting therapeutics. but the concept of applying the concept broadly has been dramatically approved by the development of affordable methods for characterizing biological information. that includes genomics, the recent revolution in mobile health technologies and the emergence of tools for analyzing

large biomedical data sets. patients are increasingly interested in taking part in research. all of these developments will help make possible the dream of processing a wide range of health applications. we're thrilled to take a lead role in the multi-agency precision medicine initiative. this initiative will focus on cancer, accelerating efforts. this component will include the molecular analysis of large numbers of individual tumor to see what gene mutations are driving the malignancy and matching that information with available targeted therapeutics provided by pharmaceutical industry partners. simple blood test will be developed that can detect early response or resistance to drug therapy. and a combination of drugs will be tested to see how best to

achieve not just a remission but a cure. to put a human face on this, i would like to paint you a forward looking picture of what the precision medicine can deliver for cancer in a few years. consider the hypothetical case of lily, a 52-year-old woman of asian decent. in 2018 after battling bronchitis and a persistent cough were lily goes to her doctor ordering a lung screen along with a new blood test to look for dna and other biomarkers circulating in her blood. the ct scan detects a tiny spot that could be inflammation from cancer. not clear. but it's revealed a genetic mutation that occurs with patients only with cancer. her prognosis from this cancer today would be pretty grim. but in 2018 that could all change. lily is treated with surgery to remove the tumor and the tumor

dna undergoes molecular analysis. and she was treated for a target drug that was originally developed for skin cancer but has the right therapies for her tumor. with this treatment a decade later, lily remains cancer free. that's a hypothetical but quite realistic of what the cancer component of this initiative could achieve. as a longer term goal, nih will launch a national research cohort of one million volunteers who play an active role in how their medical information is used to manage a broad array of diseases. the participants will be centrally involved in the design and implementation of this process. they will be true partners with appropriate privacy protections, they will be able to share genomic data, lifestyle information and samples linked to their records.

participants will be able to have access to their own health related information. new approaches for detects and analyzing a wide array of variables will be tested in small pilot studies. ultimately the most proms will be used over time to collect valuable data. that will be a great benefit to both patients and partners. let me quickly give you an example of how this can benefit a specific person but also provide evidence for a new strategy for health maintenance that could be extended across the nation. consider the case of 38-year-old precision medicine initiative participant carla. it's 2020. carla feels healthy. she welcomed a chance to try out

a wearable sensor that monitors her pulse, blood pressure and medical activity. but discovers that her blood pressure runs 150 over 200, too high, increasing her chance of stroke and kidney failure. carla is not alone. nationwide 78 million americans have high blood pressure. many like carla don't know it. what's worse nearly 50% of those diagnosed with hypertension do not have it under control. carla consults with her doctor who confirms the need for treatment, suggests she takes an inexpensive diuretic drug. carla obtains a smart bottle that sends a note to her phone if a dose is missed. so the precision medicine initiative will also bring many types of health care monitoring into this new century. current evidence suggests that the physical exam and the associated lab tests may not be as useful as one would help. but new opportunities to incorporate specific indicators

of individual health are emerging. this national research cohort will provide a powerful opportunity to ape says such strategies rigorously to see if they provide clinical valuable information and better health outcomes for the american people. in closing let me emphasize that the impact of the precision medicine will extend far beyond the individuals who volunteered to participate. it will push the frontiers of discovery across the entire spectrum from basic science, to translation tall science. given the size of the project and its real world nature, evidence of um proved health outcomes derived from this initiative will be attractive for immediate application across u.s. medical care. with sufficient resources and a strong sustained commitment of w& time, energy and ingenuity from

the scientific, medical and participant communities, the future of precision medicine appears really bright. we look forward to torquing toto make stories like lily and carla a reality. that concludes my testimony. i look forward to answering your questions. >> thank you, dr. collins. dr. desalvo, welcome. >> thank you, senator alexander and ranking member murray and to the other distinguished senators. thank you for the opportunity to be here today with my colleagues. i'm karen desalvo were the national coordinate at the department of health and human services. when i was a medical student at tulane i could never imagine that in my career i would see me sin on the such a track. we are on the cusp of being able to customize treatment for the patient in front of me based on key information instead of

having to treat them as a average patient. what is more exciting is that precision medicine is not just a theory. it's already changing practice and saving lives in the u.s. we wouldn't be on this cusp but for health information technology which is foundational to the president's precision med initiative. the office of the national coordinator is the federal lead for health information technology. and onc's responsibility is to advance the health i.t. infrastructure for what is six of the u.s. economy health care. we do this work through a mix of programs, meetings and technical assistance aimed at catalyzing the marketplace. we seek to spur and support innovation to support advancements like precision medicine. we want to provide clear and steady direction. onc has responsibility to ensure that all consumers are engaged and their interests are protected. congress created significant

momentum in 2009. the act provided funding of the support of adoption of electronic medical records on the front lines as they made the transition to use them. as the result, we're bringing health care into the digital age and we have reached a tipping point. this strong foundation of health information technology makes it possible to bring to the bedside personalized treatment through precision medicine. the data and electronic health records married with advanced and lytics and other sources of data including patient preferences will provide the picture of a person's health and needs. this comprehensive data picture is necessary to identify the right prevention and treatment that is not only the most effective but also the most desired by the patient.

this is a reality already in places like tennessee, maryland, nebraska, florida. thanks to the tools bimt into the electronic health record, doctors are able to taylor treatment today. i spoke to folks at the university of florida health where a patient's cardiologist can order a test to see if they carry a particular variant of a gene. this test will held. cardiologist know if they're using the best medicine to prevent a clot in the patient's heart. a doctor is choosing the right life saving blood thinner tailored and specific for them. and though this kind of treatment is exciting, it is indeed only the beginning. we have much work to do ahead. see that this is available to everyone in this country. as part of routine care. and onc stands ready to undertake this work. to get there we'll need to stay the course in adoption to see that every american has an electronic health record. we also need to go beyond the pockets of data exchange and

achieve true interoperaability. we'll need to establish new data necessary, environmental exposures and patient generated information. we will build a trust framework that respects individual privacy and establishes strong security protections. we will work with the private sector to establish openly available apis which are doorways to unlock data. in all of this work we'll remember what i hear consistently from consume ares who are our principle customer. they want to be able to access and share their health information, including the scientists if they wish without blocking or delay. the president's precision medicine initiative is one of the most exciting ways that we can bring the right care, the right prevention to the right patient. only imagined a few years ago. it's because of advances like this and the underlying technology to support it that we are on the cusp of realizing better care and health for everyone.

onc stands ready with our colleagues at hhs and with congress. thank you and we look forward to your questions. >> thank you, dr. desalvo. dr. shuren. >> chairman alexander, ranking members murray and distinguished members of this committee. thank you for the opportunity to testify regarding fda's role in the precision medicine initiative. the success of precision medicine depends on having accurate, reliable and clinically meaningful tests. it's the results of the tests that determine which patients get which drugs or treatments and whether or not they get them. inprecise medicine results from bad tests, misdiagnosis, you get the wrong treatment or you get no treatment at all when you should. and as a result patients get harmed and health care costs go up. fda's role in the initiative is in a technology called next generation sequences.

ngs can sequence long segments of a person's dna or the entire genome. we're moving away from the model of one test one disease. but a test that can identify one of many different diseases or the risk of developing that disease. but today there are significant barriers in place for advancing that technology. it affects the research, affects the development and the ability to use this optimally in health care. let me tell you what the lófñ barriers are and what we're doing about it. if you're making a test an you want to know is it accurate, two of the things you need to know are the following. does it accurately measure what you're trying to measure. do you identify the right variance. we call that analytical validity. and secondly you want to know is there a good relationship between what you measure and the

particular disease. if you say it's a test for breast cancer is that variant associated with breast cancer. we call that clinical validity. that's difficult to do for next generation sequencing. here's why. you have about 3 million variants and your genes are made up of components called base pairs. there are 3 billion of them. now you want to know how accurate is the test to measure all of that. normally you would look at each of the variants. you can't do that for 3 million variants. take forever. but there are good standards out there. people are struggling to make sure are their tests accurate. then if you want to know is it clinically meaningful, you need data for that. it's hard to get a lot of clinical data. it's difficult to do clinical studies and the data tends to be siloed in the institutions that are doing the testing. so in december we propose an

entirely different work on the tests. we and the developers have struggled on what to do with it. so for analytical validity, we need to have reference standards, essentially sub sets of genetic variance that if you can show accuracy in measuring those, it's reasonable inferred that you're good at measuring the other variance. we gave $2 million to the national institute of standards scientific community to come up with the very first reference standard if the genome and they just released that last week. under this initiative and with additional funding support, we'll continue to work with nist and the scientific community. as a result, the developers wouldn't have to come to the fda. just meet the standard. we need to lench databases where we get all of the genetic information and then make sure it's standardized and. the curation activity. and then working with them and the scientific community develop

standards and best practices for having these databases, for doing the occur ration and then have clinical interpretation. you know what happens today. you can send your blood to different genetic tests labs and get different results. that's what happened it may be because you missed the variance or you interpret it differently. with the standards in place we can have consistent accuracy in testing and consistent interpretation and reduce the time and cost to spur research, advance technology development and ultimately to achieve better health outcomes.

thank you. >> thank you, dr. shuren. we'll snow have a round of five minutes questioning dr. dasalvo, when i was the governor of tennessee, i had the idea that all student would become computer illiterate. flew to san francisco met with steve jobs and bought enough mac computers to put in all the middle schools. it was a great idea. sounded good. forget something. i forgot teacher training so nobody really knew how to do it. i didn't think it all the way through to the end. i think we have something of the same problem with our electronic health care system. we spent $28 billion. it's a great idea. holds great promise but it's not working the way it's supposed to. the current standards for meaningful use aren't clear, upgrades are expensive, the systems don't work well enough

to share the data. we hear it's expensive to share the data because of the relationships between vendors and doctors. some of the doctors call this data blocking. you just released a report on data blocking describing these concerns. senator murray and i have set up a group, working group to work on this because of the large amount of interest in our committee on the subject. my question is, will you work with us, this committee, to identify the five or six steps we could take to get our electronic medical records system functioning well enough so that it supports not just the precision medicine effort that we have but so that it functions and it's something that physicians and providers can look guard to using instead of enduring? >> yes, senator, i look forward to working with you all in identifying ways that we can make this work for doctors and others on the ground, on the front lines. that's where it really matters, where the work flows are

sometimes not the way they ought to be. we look forward to that. you can count on our participation very actively. we have some efforts underway as the senator is likely aware. we've been working through our rules for meaningful use for certification. but we know there's more work to be done and belook forward to that. >> what i'm talking about is actually beginning to get some results. identifying the five or six steps we should take. you should know them better than we, really. although dr. cassidy has some personal experience in this he'll give us i'm sure. and going step by step to get them done. and if you can do them by administrative order, great. we'll include them as the administration initiative and begin to do what we ought to do. dr. collins, 1 million genomes, mentioned i was visited by head of philadelphia's children's hospital.

they have 250,000 sequenced gee gnomes. how, well, one question. how many, how many of these are already out there? i mean you want to assemble a million, they've got 250,000 in philadelphia. dr. ventner want to assemble a million. can you get those by going to the philadelphia children's hospital and using some of theirs? >> that's a great question. and we're trying to come up with every possible way to assemble that million strong cohort by taking advantage of things that have already been done. we'll have a may jr. meeting in your state on may 27, 28 with a number of those who have been managing these large scale cohorts gathering together to see if there is a way to put them together -- >> can you estimate the number of genomes that have been sequenced? >> i should be clear. when you say genome sequences, some people are referring to a sampling, a gee know type. a snip chip is the term that's used. some are talking about uarpg÷ sequencing just the parts of the

genome that code for protein, we call that the exome. to do the whole gee know is becoming quite affordable. most of the cohorts have not yet done whole genome sequences. the group in philadelphia is doing it with some of their patients. dr. ventner has the sbrengs. we believe that to get the maximum information you want that. >> let me ask you quickly. senator murray has emphasized the importance of making sure everyone or a representative group of everyone is included in this. what about children? i mean the suggestion was made

this morning that sequencing the genome of a child for a genetic defect leading up to a particular disease can be less complicated than for an older person who may have a more complex disease. will you include children and the single gene therapy treatment as part of what you do? >> that is an active area of investigation by our working group. let me explain, we assembled a group of public and private experts on this whole question of of this million strong cohorts. they've met once last week and they're meeting again to talk about what should be the constitution of the cohort. should children be included. we want to be sure that covers diversity of the population as well. and some of the cohorts out there may not be as diverse as what we need. we'll figure this out. there is a desire to have this be something that representing

the broad swath of our country. there will be a strong motivation for many people to include children. >> thank you. senator murray. >> thank you for being with us. dr. collins, we've heard a lot about how precision medicine is revolutionizing the practice, allowing for the development of targeted cures for individuals. but i'm also interested in the economic impact of this work. we know that precision medicine is not only about treatment but about prevention when' have a lot to do about how factors like environment, nutrition impact individual health outcomes. how might these discoveries impact health care costs? >> well i do appreciate that question because we all agree that health care costs need to be brought under control. a lot of concern about the current system is it is a sick care system than it is a health care system. and if we had the opportunity focus on prevention instead of waiting for illness to strike,

we would improve the health of the nation and save money. the precision health initiative aims to focus very intensively on prevention and to find out what actually works. i mentioned in my opening statement something about the fact that our annual physicals probably don't collect the kind of data that ultimately you'd like to have that might be a tip off to something sma needs attention. and the opportunity to begin to use the new tools, as well as the wearable sensors reporting on the environmental exposures should put us in a much better situation to monitor individual health before an illness strikes. i don't want to overpromise the value a that this will result in as far as cutting health care costs and bending the curve that we want to see start downward again. but i would think over the course of time this is one of the best opportunities we will have to cut our health care costs. >> you know, one of the exciting

things about precision medicine is it's empowering patients and people to participate and be full partners in discovery of new treatments. you mentioned the new mobile and wearable health technologies that are out there that allow researchers to collect data on how participant behaviors affect their outcome. i know all of the agencies are working to find new ways to engage patients in their own health and sustain participation among people involved in research studies. what are the best practices in patient engagement to ensure sustained participation throughout the medicine studies? >> another great question. there are a number of cohorts that are engaged a lot of patients that we're going to be consults with about what their experience has been the mayo clinic, marsh field has one. all of these have done a lot of work to figure out what it is that people are looking for if

they're going to participate. i think an important part of what we're trying to do with this initiative is not to think of the individuals who take part as patients. they're partners. we want to have them at table. we're going to have a workshop that is focused to try to get information from the individuals, what they're looking for. people expect if they're going to be part of this that their information is going to help people. but they also would like to get information back about themselves in terms of what has been learned about their own state of health. and what has this study led to in terms of broader discoveries that might not have happened otherwise. they want to be included, informed and at the table. we promise that is the attitude we will bring to this. >> let me ask you, dr. desalvo,

we've seen several high profile sophisticated attacks on health care organizations in the last few months. americans expect that health care providers and researchers are taking the necessary precaution to protect their data. that's why i mentioned working with senator alexander on the current state of cybersecurity in the health care industry. can you tell us what steps onc is taking to help researchers keep the large amount of genetic and other information that they're collecting secure? >> thank you for the question, senator. we agree it's a major issue. it's on top of our mind every day. the steps we've taken most recently are to require in the electronic health records that day the is encrypted at rest and in motion. so as you move and data is moving across systems, it also needs to be secure and encrypted. we're working with the department of homeland security, with the national security council and others to ramp up

the additional security expectations. but as data begins to move and be liquid, there's more opportunity for there to be security issues. it's a top priority. we've taken some actions and we have some additional ones underway. >> what is nih doing to protect the patient privacy? >> we've already initiated a genome data sharing policy which has been in place for several years because we've been conducting studies to try to understand genetic contribution to diseases like alzheimer's or schizophrenia or heart disease. qualified researchers can apply to see that information. but it has to be overseen to make sure that the individuals who are looking at the data are appropriately signing on to various restrictions, such as not sharing it with third parties and acknowledging where it came from. and that's been very successful over several years. i think we have a good framework there. we think there are things needed in order to protect genetic privacy to make sure it is not acquired by individuals who do not have the right to do so. there ought to be something to

avoid surreptitious genetic tests of individuals without their consent. >> thank you. senator cassidy has deferred to senator hatch and then senator franken. >> thank you, mr. chairman. we've been following your work for years. we have a database too and i wonder if that could be part of the million person cohort. we have, as i recall -- it's the largest repository of computerized family histories and it's linked with 22 million public health and clinical records. and the scientists at the university of utah has been able

to use the noncommercial resource to identify dozens of genes responsible for diseases. now the utah genome project is harnessing the power of utah's large family. discover new disease causing genes in underlying conditions such as diabetes, heart disease, obesity and cancer. they mall fie our ability to identified disease causing genes. by harnesses these advantages, it seems to me, you know, using these large families and large cohorts. i think our folks in utah can make significant contributions to what you're trying to do here. and i would like to know if you think they would be useful and if i can play a role in getting the university of utah and you -- i think you're already working together but i think you need to work with that group as

well. >> we are indeed. senator thank you for the question. utah has been in a wonderful place as far as the ability to do remarkable research in human genetics over many decades. research i've personally benefitted with collaborating over decades of my own research clear. you have an unprecedented level of depth in terms of family collections. one of the things that we are going to be wrestling with a bit in terms of this cohort is exactly what ought to be the involvement of multigenerational pedigrees. it brings considerable strength to the effort and that will be a topic of discussion also at this workshop later this month in nashville. i would say that inner mountain health care system, i should have mentioned it early. they have a strong presence in this as well. so i'm quite sure when the dust all settles this prevision medicine initiative will have a utah connection. i saw a wonderful piece this morning in the news talking about some of this. and i think there's a lot of

excitement across the scientific community and across the country in what this might lead to and i appreciate you volunteering to help us. >> we do want to help you. university of utah has a genetics department as good as anybody can have. we've irritated harvard to death by enticing a number of very top researchers out there to utah. i think they like the mountains and the skis as much as anything. they won't leave once they get there. we'd love to be of great assistance to you. i personally appreciate all three of you. i have take an great interest in what you do other these many years, as i've been chairman of the finance committee. i haven't had as much time to spend in this committee, which i used to chair. i want to compliment the distinguished chairman and vice chairman here for the good work they're doing. they're terrific leaders in the united states senate. i just want to personally express that, but thank you. appreciate all three of your being here and the work you're

doing. >> thank you, senator. >> excuse me, go ahead. >> thank you, senator hatch. almost had to get senator warren equal time there. the order i'm calling on senators is based on who was here at the time the gavel went down and based on that, on the republican sides, cassidy and collins are next. and on the democratic side it's franken, bennett, warren and murphy are next. senator franken. >> thank you, mr. chairman. thank you to the ranking member for holding this hearing. precision medicine is extremely exciting. those of us in minnesota, thank you, dr. collins. because mayo and the university of minnesota have been doing genomics project that funded by you. very smart on your part. this is exciting because this's

really been a paradigm shift in the way we think of health care in this country, in some part due to the health care reform law, health care providers and to the health care reform law. health care providers and insurers are moving more toward a person's centered care and i'm talking about coordinated care, medical homes, aco's provide incentives and information that help doctors taylor their practice, their treatments, their therapies to meet the needs of individual patients. and that's of course what precision medicine is all about, making sure the right patients get the right treatment. and the right treatment doesn't -- as you were saying, doesn't necessarily mean it isn't treating people when they're sick, it's about health

care, not sick care. using personalized medicine should improve prevention. and so we are doing health care and not sick care. i do want to talk to you about what you said which is -- we're at a tip ingping point in electronic health records. i was going to talk about that -- we had a hearing on that not so long ago, and this -- there are some barriers to adoption by some certain medical providers, some resistance. some because of doctors who feel like i got 20 minutes with this patient, and i don't want to spend 8 of it inputting data. but on the other hand, we are --

had is where we're going. so what are you doing to address that, and what are some good models, i heard of things like having a scribe whose job -- like a medical student whose there with you and whose taking down the information. we need to get there. what are we doing to get there? >> well, senator, thank you for raising the voice of a lot of doctors in this country. i hear similar things when i travel and talk for my family members. that there's been a great advancement, we're going-forward, folks want to go there, the systems are not a part of the work flow in the way that we want or expect in clinical practice. the opportunities there include giving more time for providers to be able to implement the systems on the front line. the senator may be aware that in the last year we have put forward some rules with cms to provide additional flexibility

in timing of the adoption of records or upgrading to new ones, and also to propose in this last set of rules, giving doctors the option of a more streamlined approach to the kinds of ways they have to report. reducing the burden or the expectation on the amount of functions they must do to show they are functionally using the records. we are working toward a goal that this is going to be an enabler, and support them. i'm continued to improve in that path. we have a fellows program and share the information. it varies by doc and by office what's going to work for them. sometimes using a system, and having some assistance to transcribe over it sometimes working with the -- they've been

able to make this as seemless as possible possible. we have many more years to make sure the system is working. >> i don't mean to interrupt you, we can talk about this for a long time. i want to get one quick question in, i have a question about how the tests at fda, about how -- the tests that they're -- the fda is going to be assessing. one thing that concerns me is that some tests may get quite expensive. i want to make sure that i understand how they and the highly personalized care precision medicine can provide will benefit everyone and won't contribute to health disparities in our country. so my questions are will these

tests be considered diagnostic tests or preventative tests and who is going to be paying for them? >> well, in the case of next generation sequencing. they can be used potentially for both diagnosis and for predicting. and, therefore prevention purposes. it all depends upon do you have the data to show that that particular test can perform in such a way? in serms of reducing costs there's the opportunity for reducing costs for those technologies to be vexed. if we have the standards i talked about, and the databases of information, it will be a lot less expensive to have the signs. so in the past you do a clinical study to show, does your test predict or diagnose that disease. but now with the databases you might be able to point to that data, so essentially it's the clinical community crowd sourcing the evidence. and we just did that recently with -- two years ago with a test for cystic fibrosis, where

first we approve that ngs test based upon a subset of bearings and secondly they were able to use data in a zeta base at john's hopkins that was supported by the cystic fibrosis foundation and didn't have to reduce the study. who pays for it hopefully the insurance will pay for it at the end of the day. if they can't afford it, they won't have access. >> there's no question that medicine can bring down our costs in certain ways. i don't worry about a brave new world where certain people have access to certain things. i would just -- i'm out of time i ask unanimous consent to extend a statement from senator klobuchar to the hearing record. >> of course it will be done. thank you senator franken. senator cassidy? >> dr. desalvo we've had a gao

report in the past. they needed to do much better to coordinate their records. the research there of and the implementation. i hear there's an 11 billion dod contract going out. i'm not sure it's coordinating with the va and we have testimony recently about how there's a lack of interoperatability. so one of the systems being considered, two of the systems being considered by dod are those lacking interoperatability. i feel like we're in a thicket here and we can't get out. all we know, we're about to spend $11 billion on something that the va system is not interoperable with. please tell me i'm absolutely wrong? >> senator that is -- the dod's acquisition of the electronic health record, you are correct,

it's one of the most important things that will help the department of defense has agreed to lead the way in pointing to the standards the senator asked me earlier what are the steps we should take. >> one of the most important things to move away is proprietary standards. >> there's some open source bidders, but one of them is -- they're not open source? >> those envendors will have to agree to use the standards that the department of defense wants to use, which are the ones that the onc has published. we're pleased we're all moving in a direction to have a core set of standards that everyone will agree to so we don't run into a problem that the system -- >> the va will be able to share records or that the local hospital will be able to share

records with the dod. >> the va and dod is a separate issue. yes, sir the goal is, that becomes not only exchange or interoperatability. >> i talked to medical students all the time and i don't mean to offend. when you mentioned the goal i accept it as a goal. but how likely is it to happen? because it seemed like you left some wiggle room that indeed the da has a system that it may not communicate with dod. >> the va and dod have done now, they've found a solution to exchange the information. you can see the records from the va and the dod. they've taken that first step. the integrating of the data requires having the same core data elements, there's a technology issue which is solvable. there's also a policy and a culture issue which is generally the harder one and what we're facing in circumstances like information blocking, which is one of the things getting in the way of interoperatability in the broader community. you. >> spoke of the open source,

though, who is blocking the info? >> information blocking can happen sometimes from technology, but what we're seeing commonly is that the vendor systems will charge -- >> i accept that we've had those hearings about how the vendors are blocking. let's take it back where we started. my fear is the vendors who are blocking data are the ones bidding. you mention it's going to be open source, but you return to the fact that there could be blocking. so i guess i'm not clear. the final $11 p.m. project be something that i at our lady of the lake in baton rouge can access data or will there be a problem with the blocking. >> i would need the dod to confirm the answer if you -- since they described blocking. we have to keep putting on the pressure, i do not think the work is done.

>> is it part of the initial rfp that they cannot block and the va has to be able to share as does the community hospital? let me ask it that way. >> that's the intention of the dod, that's correct. >> it's the intention, but is it part of the rfp? >> yes that's where they're going. >> now -- >> but i -- that is what i understand from our -- we have recommended as onc to the dod. >> i sometimes find the recommendations are not adopted. >> we can certainly get back with you on that. >> yeah, and i'm almost out of time time. >> thank you, senator cassidy. >> you're fortunate to have you on the cutting edge.

there's a thriving movement of molecular diagnostics underway, thanks to the human genome project there are a number of diagnostics, there's a bowl of cardiovascular disease and lung cancer. the fda released a draft work to develop lab developed tests. i wrote a letter to you a couple weeks ago, we need to balance and create a fair and workable process. the fda could approve thousands of labs or tests. i wonder if you could speak to this a little bit given the size and scope of the issue. do you intend to propose more formal regulations in the space. would that be useful?

how do we get a handle on this? >> and create predictability for the people that are doing this work? >> well first let me say that laboratory developed tests are -- play an important role in our health care system today our goal is not shutting down laboratory developed tests, but in fact making sure that we are both facilitating innovation and that those tests are accurate, reliable and clinically meaningful under our proposal we'll strike that balance. what we've heard from the lab community. a lot of the tests they make are to address the needs. one of the things we put out in our proposal is to say you're making a true laboratory test, your health care facility is doing this and treating patients. there isn't a test out there like that you don't come in the door for premarket review. we'll address that unmet need. if subsequently someone has that test, they send us the data, we look at and it turns out we know

this test works. our expectation is other people who were making that test, we now have data of that test is accurate reliable and clinically meaningful. i don't know if we will receive thousands. we received a lot of comments on the proposal, we're working on it and we will be making changes. >> if there is legislative work that needs to be done around this, i hope you'll let the committee know. i'm sure you will. i wanted to turn also one other topic around, inning know vague. dr. collins mentioned earlier how important mobil technologies have become. really, in the blink of an eye this is all changing the way doctors practice medicine patience monitor their own well being. and as you know, probably senator hatch and i reintroduced the med tech act to ensure the lower risk medical software mobil apps are not regulated by the fda. i think we share the same goals

on this and i want to thank your team for giving us technical advice all the way through. can you talk about fda's thinking in this area? >> first, let me thank you, and senator hatch and your staffs for the opportunity to work together on the med tech act. and we agree, as we looked at this space, we were looking at functions, device functions we had been regulating for a long time. some of them are being put on mobil platforms. and what we found as we looked at it is, some of these lower risk functions we may better serve by no longer actively regulating them, and spur a little more innovation, they're specifically low risk we don't need to provide that fda oversight. instead, focus on higher risk medical device functions in the space. that is a nice balance on that facilitate innovation, but still assure good patient safety. >> thank you. i don't know if you have anything you want to add, dr.

collins. >> only that i think your point about mobil health technology is extremely taken. >> exciting opportunities are happening around us. we certainly see this precision medicine as a great opportunity to test those out. you not only want to have an application that's cooped of cool and gives you interesting information. you want to know does it improve health change outcomes? if we have a million individuals who are excited about participating in research, who are essentially volunteering to become users of these kinds of technologies whether it's the next version of a watch that measures all kinds of aspects of your body's physiology or something that's detecting in the air around you what kind of exposures you're having. this will be a great opportunity to find out what works, what improves health care and what ought to then be extrapolated and utilized across medical care for the whole country. >> thank you. thank you mr. chairman. >> thanks, senator bennett.

senator collins? >> thank you very much mr. chairman. dr. collins, just this morning i met with some advocates from maine who are pushing for more research into brain cancers such as glee yo blass tomas, you mentioned in your written testimony that oncology is the clear choice for enhancing the near term impact of precision medicine. and that important advances have been made in this area. so i very much look forward to sharing your testimony with this group of people from maine who are concerned about such devastating brain cancers as glee yo blass tomas. i'm wondering if you also see a role for precision medicine in neurodeagaintive diseases like alzheimer's, parkinson's and als. are investments in these

important areas also being considered as part of the precision medicine initiative? >> thank you senator collins for the question. we are learning that disorders like parkinson's and alzheimer's and other neurodegenerative conditions do have multiple contributions to whether they happen or not, to a given individual for alzheimer's disease, we know of 35 individual places in the genome where variations place an individual at higher risk. we know about one or two where individual variations are protective, which is an even more potentially actionable finding, because you'd like to understand that in order to develop the next generation of preventative strategies for people who weren't so lucky as to inherit that preventative kind of genetic variation. so there is -- especially for any disease that is common enough that you're going to have

thousands of individuals in your 1 million strong co hort, an opportunity to study those at a scale that has not been cost and to try to put together. >> all the things we can learn about the genetic inheritance but also their environmental exposures. also, everything we can about their electronic health record experience. using mobile health the ways we can come up with better detection systems. that is very much an intention of this i think one of the exciting aspects of having this very large co hort is that it doesn't have to be just about heart disease or just about diabetes or just about alzheimer's disease, it can be about all of those things, it will have the scale to do so. we have waited a long time to reach the point where the technology would make that possible and the time is now, we've really reached a remarkable inflexion point in medical research and we should not let this moment pass.

>> i could not agree more. i think it truly is so exciting. dr. desalvo despite the federal support that you mentioned in your testimony i continue to hear from smaller health care providers about the barriers that they face with electronic health record implementation. just yesterday i met with a physician from bangor, maine who shared with me that putting in place a comprehensive data collection for his small practice was going to cause in excess of $230,000. this was just for the software, not for the hardware. that's no small amount particularly for a smaller independent practice that is not hospital owned.

to access information about individuals to improve diagnosis treatment and prevention of diseases. you discuss the important role the absolutely essential role of health information technology and interoperatability including the standards in technology that are going to be needed. as you were to build these health i.t. systems for precision medicine. how can we assure that we're not leaving out rural america? smaller practices? rural hospitals health clinics because of the cost? >> thank you for the question and for -- particularly spotlighting one of the challenges of small practices and rural. that was a particular focus that we had early on in the high-tech funding that was prior to me joining the administration, but

the team really wanted to see that rural america was not left behind. there was great success in the adoption, in many of those communities across the country in partnership with the usda as an example. they are facing a challenge of upgrading technology, it is one of the reasons last year because of some challenges they were having that we put out this flexibility rule that gave them some more time to advance. the cost you're describing for that sounds very exhorbitant. you are exactly correct, it's critical we get this it's critical not's left behind. and we find a way to make it successful for everyone. >> thank you very much i'm going to take you up on that. thank you, mr. chair. >> thanks senator collins, senator warren? >> thank you, mr. chairman. the president's precision medicine initiative could be a big step forward for more

targeted more effective therapies for any number of conditions. i think it's a great idea. we should have started years ago. dr. collins you first advocated for a national genetic study to examine how people's genes and environments contribute to diseases over a decade ago, 2004, is that right? >> in fact that is exactly right. and it landed with a thud at that point, that's actually the article on the screen that i published in 2004. in retrospect, this was probably a bit ahead of its time, because we didn't have the technology at the point where this would have been affordable or practical, it is now. >> i'm glad to hear that it is now. if we had started pushing and funding back then. we can only wonder how much further we would be ahead right now. congress didn't make those investments, over the past decade, nih funding hasn't kept

pace with inflation that means we are years behind in doing this work. if we are serious about speeding up biomedical information. about improving help about reducing long term costs we start by investing in nih. the house has a proposal called 21st century cures that's supposed to accelerate biomedical innovation, when it was first released by the republicans a few months ago it didn't include a single dime of new nih funding for congress. last week's new bipartisan draft of this bill very much seems to be moving in the right direction, it has $2 billion in new mandatory funding for the nih every year for five years, and i applaud the house republicans for acknowledging what so many of us including newt gingrich and the drug industry have been saying for years. nih funding is critical to accelerating cures.

let's be clear, a few billion in temporary funding will not solve a decade of neglect much less build the future that we need. so dr. collins in the late 1990s congress doubled the budget of nih, and then agency funding was left to shrink back down. if congress had never doubled the budget of nih and had simply kept pace with prior investments, where would the nih budget be today? >> i keep a graph in front of me all the time about this very question, and i'll put it up on the screen, because this is a documentation of the problems that we are now facing. what you're seeing on that screen there the yellow line is what nih has had as far as our purchasing power. it's the appropriation adjusted by the effects of inflation. the dotted green line is the trajectory that nih was on, going back to 1970 until 1998

when we had that wonderful doubling, but we've been getting undoubled ever since. you follow the dotted green line we would be substantially hire up in the neighborhood of a little over $40 billion. >> just to get back on track and to reverse the damage of the last decade nih would need more than $12 billion in the first year, and the house proposal doesn't put that much in over the space of five years? so let me just ask, based on what you have here in your expert judgment, what's the annual rate of increase that nih needs to get back on track on its funding? >> first let me say we were thrilled also to see what's in the 21st century cures $12 billion a year, gave a great jolt of excitement and relief to the community that's been quite stressed over the past 12 years as we've been losing ground.

to get back on a stable trajectory that would result in a healthy biomedical research ecosystem which our country has depended on with great success over 50 years. i would estimate we'd need to be in the space of inflation plus four or five% per year. that's pretty much the dotted line. that was a healthy way to be sure that all the talent and capabilities of this country in terms of biomedical research where we have led the world for decades would be sustained, encouraged and innovation could go forth in all the ways we wanted to. >> thank you, dr. collins. $2 billion a year for five years is certainly better than nothing. let's not pretend that a small temporary investment that falls billions of dollars short of what we're going to need to do the job, there is a gaping hole in our nih budget and we need a serious plan to fix it. there are many ways to make that happen. i have a medical innovation act

for example that could add another $6 billion a year, wouldn't cost taxpayers a dime whatever we do this committee has to get serious about medical innovation, and that means we have to do better than the house proposal on this. thank you, mr. chairman. thank you, senator warren. >> let me start by echoing the chairman's interest in having a review of where we are on health information technology. i read with interest the wall street journal piece by your predecessor. and i think it makes a lot of sense and provides some bipartisan foundation for us to work forward. i think that the meaningful use program has become obsolete and needs to be tuned up to meet the new challenges that the progress

over the last year since it was passed now present to us. so thank you for agreeing to work with the chairman and the committee on the four or five key goals that we should be achieving, and i would urge you to think big in accomplishing that let's not tweed el around the edges let's get this right. dr. collins, to follow up a little bit on what senator warren was saying, i'm interested in what you've been able to document by way of consequences for failures to adequately fund our scientific and medical research. it strikes me that you could probably tell me that there's a return on investment from the research that we do, and if we don't fund the research, we lose

that return on investment. it strikes me also that you probably have examples of human benefits from the scientific research which if forgone become human costs, and you probably also pay some attention to the country's global competitiveness in this field, if you can comment specifically on those three areas on what you think is the pay back for investment in scientific research, or if you want to put it contrare illy the cost of not funding scientific research. >> i appreciate the opportunity to talk about some of those consequences. put up another graph that reveals the difficulties that are present in this country beginning back in 2003, what i'm showing you there is the opportunity that an investigator

who comes to nih with their best ideas has of actually getting funded. and most biomedical research done in this country and our nation's finest universities and institutes is supported by nih. for most of our history that has been in the space of 25 to 35% success rate about 1 in 3, that's not easy that means 2/3 of the people are sent away. now in 1 in 6 and that's very unhealthy, we've looked at what happened in the past when we could fund up to 30%. and there's a lot of great science that falls in that space between the 16th percentile and the 30th percentile, we're not funding that now, about half of what we should be supporting by historical trends is left on the table. we don't know what we're missing in that regard. the next great idea about cancer may have been one of those things that didn't quite make the cut. in terms of your question about medical consequences. i'm a physician. the reason i love being at nih

is the hope that this is going to change things for the better for people's health. our track record there is striking in terms of what's happened, in terms of longevity and disease. it's frustrating that we're going more slowly. i promise you the institute directors and i sit around the tabling and try to figure out what to do we still prioritize and push forward. we're just going more slowly. we need more advances in cancer we need a universal influenza vaccine, we're working on all those things but we could be going faster than we are right now. in terms of the financial return on investment, that's been documented over and over again. we support about 400,000 jobs directly across the country in all 50 states on the basis of the grants we give out. those are high quality jobs. you asked about global competitiveness. we were the unquestioned leaders

of the world until recently that is no longer to be taken for granted. when you see our losing ground and we see countries like china and india and singapore and south korea upping their investment sometimes in double-digits, we are losing that. >> when they are making those increases in investments, do they have an eye on us as a target to -- >> you bet. >> are they just doing this in a general way? >> it's a little of both, they basically read our playbook from 20 years ago, and they saw what we did from america's economy. they want to do what we did. i don't know if you'd say they're gunning for us, but they're trying to learn from our experience and re-create that in their environment. one statistic that i think particularly renders this a serious last year, china filed more patents in bioscience than the united states did. that was not even a close competition a couple years ago they have jumped ahead of us.

those patents resulted in intellectual property claims that are going to spin off new businesses. we have to take them seriously. >> thank you, chairman. >> does that mean that china will start respecting patents more? >> i think i better not comment on that. >> don't get the man in trouble. >> yeah. >> senator, thank you. senator baldwin? >> thank you mr. chairman i very much appreciate you. and ranking member holding this hearing. >> precision medicine initiative. we're excited about it because it's life saving potential. we're excited about it because it's breakthrough potential, i'm excited about it, having the honor of representing a state that's been a leader in setting the stage in things we're talking about today in precision

medicine from the first embryonic stem cells to the discovery of short tandem -- at marshfield clinic which is major discovery that has had a big -- i think a big impact on the study of human genetics, and the clinic has since developed a very significant genetic biobank. one of the larger ones with information from over 20000 central wisconsin residents. dr. collins, i know you've been asked for iterations of this question before by my colleagues on the committee. but if you have more to add i would like to hear more about how you'll utilize the existing data, like the data that i just described that was collected by the marshfield clinic, and real

world clinical data. how will you use those and share those in new ways to create personalized therapies. >> that's a great question. yes, marshfield is a wonderful leader in this enterprise, i visited there myself several times, and dr. murray, who's the person overseaing their large co hort somebody that i think we're all looking to for his experience to share with us, and he was at the white house when the president announced on january 30th. in this workshop we're going to hold at the end of this month at vanderbilt, we will really look hard at the ways in which marshfield, mayo, intermountain, kaiser permanente, geysinger and perhaps the million veteran's project as well, could be assembled into a synthetic kind of co hort, not having to do all of the work from scratch but making the whole greater than the sum of the parts this kind of initiative really builds power by numbers, and that's one

of the reasons we're so excited about being able to say that word million, which would note have been in the vocabulary of most people planning these things until recently. we want to take every kind of opportunity to build on the experience that's been obtained in places like marshfield. one of the things they've done they've found individuals who by logging at their dna sequence ought to be sick but they're not. they have some kind of resilience. some people call them genetic heroes, there's something about them that we need to understand. they have a resistance to disease. that's just one kind of insight that they've gotten a start on. but if you had a million people, you could find a lot more. >> i want to follow up on a discussion you were just having about the research workforce, you were talking about funding and the reducing percentage of

research grant applications that are actually funded. i'm curious to know what impact this initiative may have on the changing nature of the research workforce. it strikes me that doctors who happened on discoveries of novel therapies in the course of treating patients. but others may not know their patient's unique reaction holds the potential for breakthrough in this field. what opportunities for new and nontraditional researchers are presented through this initiative? >> that's another great question, and i'm glad you brought it up. this precision medicine initiative will not reach its full potential if it doesn't lure and recruit all kinds of people to get together to work on this, i think a parallel here with the human genome project i had the privilege of leading where it was a historic

opportunity, people who never thought of themselves as working in that space decided to make it their passion. we would want to have computational experts we have very large data sets this is the world of big data in the best way, we would want to have technology developers of all sorts, to figure out ways -- what about all of those ma tab lights that are floating around in your system we can begin to look at hundreds of those in a given situation. all the technologies we mentioned about mobile health, there's lots of opportunities there as well. and physicians who can begin to figure out how can you take this kind of data and implement that in a real world setting in order to improve health outcomes. i have to say, when i look at the way we practice medicine today compared to when i was a resident in medicine in 1979 or '80, it's not that different. we have such a long way to go here in terms of really incorporating all the new technologies that are coming along, this is going to be a wonderful laboratory for all

kinds of people to get involved and figure out what kind of discoveries can be made and what use we can put to them. i hope it's going to be filled with that kind of innovative talent. >> i appreciate that. mr. chairman with your indulgence, one quick question you can answer this for the record record. there's incredible potential in what we're talking about but it also strikes me that there's incredible potential for fraud, for folks as this develops offering selling fraudulent interventions that claim to be personalized medicine. i would like -- again it can be after this hearing to hear from you more about how the fda will work to prevent fraud and ensure patient safety in the age of precision medicine. >> i'll take a quick moment if

it's okay. just to say -- >> senator murray and i would like to know the answer too. >> thinking of just beyond fraud, the whole point of having a test out there that doesn't work and it's being sold, this is one of the impetus in terms of our now deciding to regulate the subset of laboratory developed tests there are some great tests out there but there are some bad tests out there, let me give you an example, one that's in the precision medicine space and there's several of them. it's used for people having coronary heart disease and their response to staten treatment. and this is a test where we had seen data on it, we saw the test didn't work. laboratory developed tests, they're selling it. 19 clinical studies test doesn't work. then they performed a randomized placebo controlled trial on over 18,000 patients. the test doesn't work. and when this was reported out

around 2010, at that point, over 150,000 people got that test. we estimate the cost to the health care system may have been upwards of $2.4 billion. that test is still available today. and that doesn't serve patients well and it doesn't serve precision medicine, it undermines our efforts to make sure we get accurate and rely around tests out there, and we get the right treatment to the right patient. >> senator murray, do you have any further remarks? >> how are consumers supposed to know that? >> right now they can't. >> they don't because you don't have that oversight for some of these tests for knowing are they in fact -- >> does that mean you don't have oversight for this? >> we do have the authority, and what we proposed is it's time for us to exercise it. laboratory developed tests tended to be very simple. they were used locally, often

rare conditions and so in setting up the program we said we would exercise enforcement discretion. your subjected requirements were not enforcing them, over time, particularly without being there, these tests have become increasingly more complex, they're being used nationally they've become increasingly more important than being relied on for health care decisions. as a result of that is why we move forward to regulate them, but i have to tell you this question's come up from the 1990s, we had nih back then, the department of energy saying the fda needs to get involved. the instoi toot of medicine comes out in the 2000s to say that, two advisory committees to the secretary of health and human services, we've been trying to move forward. we put out a guidance that says we'll start regulating a subset. don't pick away, don't chip away at this, put out an overarching framework, make it risk based. we held a public meeting in 2010, we got that input. and the guidances we put out,

the framework we proposed in late of last year, was our attempt to do that. have a risk based program, trying to balance innovation with patient safety and phase it in over a period of time. and right now, we're addressing comments. still working with the community on what that right policy should be. >> they're engaging providers and patient groups as you work through that? >> yes, i've gotten a lot of feedback on it. the american cancer society has seen tests where they're incorrect. patients are getting diagnosed with cancer when they don't have it, and people who do have cancer are told they don't. we need better oversight here. we need to make sure we have accurate tests and the tests do what they claim to. >> one more question, dr. collins, why is one million the right number. it's a great question, there's nothing magic about 1 million, except it's a nice round number that we could aim for. i actually will admit that i

would love if we could go beyond that. as i said a minute ago in conversation with senator baldwin, this is all about numbers, that's where you get the power of the analysis to find out what works. million is very ambitious, it seemed like a goal we could set for ourselves to try to achieve. given the fact there are cohorts out there which collectively have enrolled more than a billion people if we can figure out how to do this, we can do better than that. >> just listening to the committee members you've been talking to i think every one of our states has some -- we have fred hutch in my state that is develop aa database. i don't know how you're going to work through all this, to get your co hort but diversity, making sure that we represent everybody is really important, so i'm going to look forward to how you do that. >> if we just put together the existing cohorts i don't think we would have the representation we need in the country.

>> thank you. thank you mr. chairman. >> this was the high risk low risk difference you were talking about in these laboratory tests. you're focusing your attention on the high risk airs, is that right? >> well, the high risk low risk we were talking about earlier was on mobil technologies. but here too, we try to put a focus on when we implement this, to focus first on the high risk test as we phase that in. >> any of your enforcement strks all prior approval or is it where you might be acting on a complaint? >> in other words to let the marketplace run for a while on the lower risk items and police it in effect. for the lower risk test, we

would not enforce requirements on them, other than tell us what you are. we also wouldn't force requirements on tests for rare disorders. and again some of these tests for unmet needs as well. >> this has been very useful. this is kind of like going back to college. you know it's actually very interesting, and we're privileged to be students in the classroom with such distinguished teachers and witnesses on an important -- a subject that's so important. and one that the president, the house of representatives and this committee are committed to work on. is my hope and senator murray and i will work out how we will do this, it was my hope that we can finish our work on our -- innovation initiative this year and report it to the full senate early next year, so it can be act ed acted on some schedule like that we've got some other things we

have to do as well. but the precision medicine proposal by the president would be incorporated with it it would be part of all of it. we -- i didn't -- we didn't talk about privacy today. who's going to figure that out. >> very important question. onc, inh and the white house istp have been engaged in this. we will have a deep conversation about this july 1st and second with the workshop that's coming forward at that point. >> you're going to have a million participants or more, and you use all their data you have to figure out some way to protect that. >> we're deeply serious about doing that in the most high-tech thoughtful capable way. with a fair amount of experience to build on, we have to take that with great seriousness. >> and dr. desalvo i think you

heard from a variety of senators that are interested in helping you figure out what the steps are to actually improve the electronic medical record system, get to see some real results. coordinate properly with whatever the defense department is doing. there's a lot of work to do there, we're not trying to catch anybody here we're just trying to fix a problem. we'd like to work with you to do that, and to do it soon because it affects many physicians, many hospitals and as we've heard today in a couple important ways, it's essential to the precision medicine initiative. there's no other -- i've got a final page i'm supposed to read. the hearing record will remain open for 10 days, members may submit additional information

for the record within that time if they would like, i'd like to thank senator murray again for the way she has conducted -- help us do this in a bipartisan way, we learn a lot more that way. the next hearing will be tomorrow on higher education the committee will stand adjourned. all this week here on c-span3 it's american history tv in prime time. tonight abraham lincoln's assassination. on the night of april 14th

1865, john wilkes booth shot president lincoln as he sat with his wife mary watching a play. the bullet still lodged in his head, he was carried across the street to the peterson house where he died the next morning. we'll look back on that night with events from the ceremony honoring the anniversary, tonight starting at 8:00 eastern right here on c-span 3. coming up next here on c-span3. a changing landscape of television, technology and the internet. key industry leaders discuss the latest innovations and their insights on what the future may hold for consumers. speakers include brian roberts. tim armstrong and former sec chair michael powell who now is the head of the national cable and telecommunications association. these discussions were a part of the three-day internet and tv expo held earlier this month in

chicago. >> you may be wondering what these chairs are doing here. we decided to do something different with the association this year, michael i know last year came out and put on a big old show. this year he thought maybe he would snap chat the whole thing or perhaps parascope, that would have been in bad taste. i know you all don't want another power point as exciting as those can be for everybody. what we decided to do was an actual interview with a real reporter, that would be me. and i also play one on television, on hbo. we're going to do an interview and later we're going to do a bunch of interviews. and throughout the show, peter kofka is going to be interviewing figures. i brought my own chairs. these are the red chairs of the code conference. before that it was all things d, and many many people have sat

in these chairs, including steve jobs and bill gates and president obama and so we thought it was appropriate that we put michael on the hot seat to begin the show. michael? ♪ >> were you scared? president obama? >> no, i wanted to be left of center or something. >> i hope not, that's a horrible thought. no, we have them cleaned every -- >> that's good to know. >> some of those internet billionaires can be very messy. anyway, we're going to be talking about a range of things today and all kinds of things have happened in the cable industry. let's start off with the concepts of what you're trying to chain, because the industry is changing rather rapidly and suddenly even more than it seems, especially because of digital challenges you're facing? >> i think the central reason we

rebranded the show and really changed, if i were to put it in a sentence, is to expand our peripheral vision. it's become so much more dimensional much more textural. television and technology is brought about by internet functionality. it was time for our industry to look beyond its traditional bounds and players and invite them and include them in a show that attempts to be the seminole place about the conversation about the trends that are taking place. >> this internet thing has been a big deal with the kids for a while now. people seem to be using these crazy technologies. when you talk about peripheral vision, it's been happening for a while.

all kinds of music industries have been disrupted. has the cable industry responded quickly enough? people talk about millennials decoupling from cable and watching in different ways. >> i think they've responded but i think it needs to be access rated with a new kind of urgency, as you say, i think we're starting to see a set of exponential leaps in transformation as those children who grow up, really begin to move into the older generations and our consumers. they're setting the tone of a new kind of behavior that i think is nontraditional. when i look at kids today i think that they -- you can get fascinated by the technology but you really should look at their behavior i think teenagers are doing the same thing teenagers have always done. they're passionate about community, about their friends.

they're passionate about watching each other and building friendships around that, and i think what's really come into their world is the ability to have real life be entertainment. to have the video or moving pictures of people doing things profound and idiotic. but they're able through the screens of devices and a connective tissue through the internet, to be plugged in to their friends and community, so what's competing with traditional television is real life. the ability to document share and propagate that. >> what happens to an industry in that situation. it would seem that if people are not linking to cable they're not having a relationship with cable in anyway they have bad feelings toward it or don't even use it. i don't think it's bad feelings, i think my kids watch they have a different attitude toward things, when my son was four for example, we bought a new

large television, when he got home, he started hitting it. i thought he had mental problems at this point. he kept hitting the television. i said, what are you doing? he said it doesn't move. he was so used to a swiping situation. my older son almost lives on vine, vine is entertainment to him. now he's parascoping almost all the time. most of it inane true. not to him and his friends. i'm wondering, how do you meet that challenge when the behavior's change so rapidly. >> i think the first thing you have to really be thoughtful about, you have to go to the physical locations they're going. i mean nor the better part of the television history there was one consumer electronic device that was central to you being able to consume content it was the television set. recent studies have shown real declines of people watching on that particular vehicle it's been in the last decade we've handed our kids smart phones,

tablets, laptops, there's a proliferation of screens. i think what's missed is more intimate screens. my kids can cuddle up and have a sphere unto themselves. you have to get to those screens, one thing cable has tried to do is to port their content off their systems on to those devices, i think that's the first step that's really important. then i think you have to think about, how do you exist as a companion to the self-published self-created kind of content? that lives on the internet. and if you want to be part of that experience or companion to that experience, i don't think it's enough to ask the consumer to completely change ecosystems to go from watching parascope to watching game of thrones, i think you'll see more integration. >> speaking of parascope and game of thrones, a lot of people parascoping the first game of thrones and then the ceo of twitter seemingly talking about

what a victory it was. how do you -- do you look at that as a victory? the ability to live stream anything you want. meaning you could put a camera in anybody's face at any time, and reach -- the other day i parascoped my lunch by the san francisco bay and i got 5,000 viewers. >> exciting, i missed that one. >> it was a gripping episode of shrimp salad. how do you imagine what happens? it creates real problems for the industry. they sold this for a lot of money, and lots more people watched it because of that. >> yeah i think -- the way i think about disruptions is, they tend to come with an enormous amount of good and an almost of bad like all things. the good is an amazing experience in which you can have this dynamic almost spontaneous experience with people from around the world who are documenting and cataloging events that you would never have had access to, but what comes with that is you know, in the instance you're talking about,

there are opportunities to violate intellectual property and copyright, there's opportunities to frustrate models that have been built and a lot of people have invested models that have been built and have been invested in. and i think the second thing that i find to be worrisome is what privacy means in a spice like that. you know, i have been playing with per scope and the snap chat stuff and what i'm intrigued by is not the people doing it but the people caught by doing it. the people who didn't agree to be broadcast around the world who you are observing having a drink or doing something else in that confine. society will be working through the meaning of that for a long time. that has a negative side. >> what companies will be important? you talked about bringing the digital companies in.

is it goog well the ability to do a lot of these things or amazon or apple? >> i do not know if i would say who is the most powerful, i think google, you have to i follow. i think google you have to intensely follow not only because of their dominant position in the search ecosystem. they are how we mostly find things and we are always looking for ways to index, tag and identify anything in the digital space. through their algorithms. that is a powerful function. the youtube property is fascinating. the first time i ever saw a youtube with my 12-year-old who showed it to me and i was amazed at that. you look at the soaring of video clips and miniseries and shows, absolutely think it's something to watch. and i also think amazon for a similar reason. what i'm intrigued by by bose of

those companies is the video isn't necessarily their primary business. >> no. >> they are using video to drive very very profitable businesses that pull there. amazon wants me to be a prime consumer and buy my shaving cream as well as watch a television show. they can take certain risks, burn money in certain ways that would be harder for a traditional company. >> they are not very profitable. that's the whole point. >> true. >> for decades now. >> but the market lets them take the risks that if you are an incumbent company in a cable company it would be harder to take those market risks. you have to watch -- the real ground up digital destructors, you have not seen the discovery functions on snap chat and have never looked at a per scope or played with rhine or meerkat, you owe it to yourself to go

look. there is amazing creativity going on, i do not know how much of a business it is, i know it is meaningfully -- you would be foolish not to be an observer of it. >> truly entertaining. you can spend hours just watching people fall down. when you are in this environment, what is the modern cable network look like and what does the modern cable company look like? because at some point it will just be about the member of the dumb pipes is the connectivity is important and everything else rides on top of it. >> i thunk you touched on it. the first thing that cable distribution is about is they are the country's unequivocal leader in the broadcast band infrastructure that makes all this possible. as the demands for video, disruptive applications soar, the nexus -- of high quality, increasing capacity, heavily invested in is even going to be at higher premium.

the greatest thing the cable industry has as distributors is providing that infrastructure and growing it, currently at a rate of 50% increase of speed per year $16 billion last year alone in investment that will keep that experience possible. that will be an important part of the cable business. i also think we shouldn't declare its demise prematurely. there are 102 million cable multichannel subscriber households in the country, that will not drop down to five overnight. i still there there are high quality premium programming and live events that continue to be driven by a proprietary quality of service commitment that the cable infrastructure does. the internet is wonderful, but you get what you get, as sling discovered when it had congestion problems when you have a huge demand. >> they had legal problems as well.

>> it had legal problems as well. your bits are competing with all kinds of other debts. there is not a lot of permission within the regulatory structure to manage those bits in any kind of priority. there will be needs for high quality proprietary networks that can take advantage. >> so in that vein customer service issues, not -- customers liking the internet. i mean, in the net neutrality it had a lot to do with that idea, the customers -- they played that rather well. >> sure they did. i am a firm believer that words and messages do not work if you're not liked. when i was in the army, patton said, i do not have to be like to lead. that's completely foolish. i think you have to be well regarded by your customer base. i think you have to have a trusted relationship with them. if that is frayed you are just

ripe for every next public policy fight to be turned against you based on reputation or critique. the good news is this industry is highly conscious of that problem. they are self-aware. they are not delusional. there are very important, committed efforts to change that perception over time, improve the quality of the product and improve the experience. and i think what they have to recognize or we do recognize is that even if you're improving at a rate of 3 x the consumer backically make and expectation is increasing even faster. one thing the internet has done is raise the expectation of consumers in a way they consume digital content, they wanted here, now, on any device, they want it to be unflailingly reliable. they want it to innovate every six months, not every 18 months. if you will be in the game, you have to have goals twice as fast. >> i was on a plane yelling about the internet and activity. -- connectivity. and you are in a tube of death

and you are downloading different things and mad if it's not fast enough. >> that's right. >> but that said, it doesn't matter because that's what people expect. when you are looking outward, we have a few more minutes. when you look outward at the industry, what is a cable -- is there a cable industry? should be the called -- i know you put the x on the end. it's a nice look letter. >> xs are good. >> it looks modern. >> we didn't capitalize anything. >> we use a slash. it bothers people a great deal. pungtation is everything. should it be called a cable industry anymore? it is sort of like saying we are a motorized horse? how do you -- >> motorized horse, yeah. car. driverless car.

>> you will be watching -- that's an opportunity for you an driverless car, you can text drink and watch television at the same time. >> i was at las vegas at the ces cars in and all they were talking about is whether the open carry laws could be eliminated in a driverless car. >> leave it to vegas to be ahead of things. >> is a great question. i hate the name. i do think it has a proud history. but it needs to be retired in some way. because i think that your past can be part of your glory. but it also can be a weight around your ankle when you looking at a due multious future with new challenges. and i don't think it fairly captures what they do. this industry has successfully deployed the most sophisticated infrastructure in the history of the world and the fastest amount of time of any technology in the history of the world. and increases the capacity of

that at exponential rates. it should be more centered around the future associated with the internet and less in the minds of consumers with great disruptions it made when it revolutionized tv, and i think that is a cultural change. it matters what you look like, it matters what you call yourself. it matters that i did not wear my tie. >> abig move. >> it's a huge move for you. >> larry page is quaking back in silicon valley. he's not wearing shirts any more. >> that's why i smelled the chair, i'm sure. >> that was mark zuckerberg. my last question. we have to wrap up and get going. what do you think -- what would you like to see invented? is it v. ? -- vr or surround entertainment. give me a prediction of the most eye-popping? >> i think it's going to be holographic. >> okay. >> i think there is going to be

a day where game of thrones almost plays out in three dimensions in your room. >> do you have to be dismembered as part of that experience? >> absolutely. what is game of thrones without a beheading or blood. they is more dangerous when you play in it with them. i hope that's after me. >> michael, thank you so much. >> thank you for coming. [ applause ] ♪ >> ladies and gentlemen, please welcome the chairman and ceo of comcast corporation, brian roberts. >> great