they had not kept up with the technology developments and the other opportunities. it was painful to look that the a couple of years ago and concluded we needed a different approach. that we didn't want to continue to expand a program that clearly had deficiencies that was not going to be as successful as we once hoped and that was the reason, with much advice from experts, we decided it was time to close down the national children's study and come up with another strategy. there are many samples and data available from the individuals who were enrolled in the national children's study although it was a modest number, it was all pilot programs and those are available to researchers who are starting to mine through them and see what data can be derived but at think at this point we turned our attention to how could we achieve the same goals of understanding what are the environmental influences on children's health and how could we get those answers now in 2016 in ways we couldn't have imagined possible 15 years ago. >> explain to us how that $1.5 billion in investment will carry

over into echo? specifically as you can. what can we take from all of that investment and know that now with this additional money, the $165 million requested for f fy-'17, how can we know that that $1.5 billion is not time and money wasted? >> well, it's not time and money wasted in the sense that there are these pilot efforts run that have research samples available that people can study which will help us guide what kind of decisions we want to make with the new program, echo in terms of what kind of lab measurements and environmental exposures will be most important. if i can, echo is focused, in fact, on four areas which seem to be particularly compelling based on what we learned through the study of the national children's study, namely upper and lower airway asthma, obesity, post-natal outcomes and neurodevelopment, including autism. that's where we want to go now but in a way i think will be more efficient and will result

in more meaningful data that will involve many more data access opportunities for researchers around the country who have good ideas about how they'll learn from these, how we can do a better job of keeping our children healthy. >> and the report that was required in the language in the omnibus said you should submit a spending plan on the next phase of the study no later than 90 days of the enactment of this act. where are we on that? can you give us some highlights? >> i'd be glad to. we are planning to submit that report a few days late because we are right now at a very formative place for echo. what we're doing is to invite those who have been running cohorts of children where they've already collected a fair amount of data to join this effort and we will make it possible for them to have additional laboratory measures added to what they were already doing and create a hole that's greater than the sum of the parts with perhaps 70,000 or 80,000 individuals, children, on

whose follow-up information we can add further data that is going to be something we'll learn about fairly soon, the applications are due on april 15 for cohorts to say they want to be part of it. we hear noise about that i'm in the process of recruit ago director for this effort and have an exciting candidate lined soup there will be a lot to report about how we're pending the money. we're grateful to the congress for your confidence this was something you wanted to continue and provide the resources for and i think although we've gone through a difficult transition here what we're on the path to do is going to be more successful than i could have thought possible five years ago. >> i yield back. >> i go to my good friend, the gentlelady from california. >> thank you, mr. chairman. i'd like to follow up on the question of ms. robey with regards to echo. i think that you said that you are putting together that ten-year plan and that will

include, i assume, milestones and funding estimates in that plan. and when do you expect that the recommended advisory panel with outside experts are to be established? >> those are highly appropriate questions. at the moment, the plan is for a seven-year effort. we would very much want to see how we do in seven years but expanding to 10 would be the hope if this is a problem going well because it should couldn't to yield new information as we follow these children over time. the advisory committee is being put together. it will be formed as a working group of our council of councils. that's important because this echo program involves multiple institutes at nih. you might guess particularly the child health insurance. but others as well. we need to have this positioned in a place where we have advice from expertise across many different disciplines. that's where our council of councils come in and where we'll

position the advisory panel for echo. >> the congressional justification mentions about six research activities for which ncs funds were directed in gift. are these the cohorts or are you still identifying cohorts and i want to throw in one more question because of time will the away of cohorts include broad population samples and measures specifically designed to compare the study of cohorts to known national samples such as the national health and nutrition examination survey? >> great questions. in terms of what cohorts will be involved, we decided this was best handled as a competition so we put out a funding opportunity announcement and are waiting for april 15 to see who comes in to apply. we expect many cohorts will be very interested in taking part because it gives a chance for their work to become even more

meaningful. we will want to see that happen. and certainly we will want to take full advantage of the national study that has much data in it about environmental exposures and other measures of health and knew troigs do comparisons with what we see in these cohorts. it's wonderful we have that foundation from other studies to do this with. there's one other aspect of echo that deserves mention and this is an effort to set up in the idea states, the states that don't currently have a research intensive university setting a pediatric research network. there's so many things we could be doing in terms of pediatric clinical research in those states but we're not set up to do so. so this is a proposal to build upon the expertise happening in those idea states to create a pediatric research network to enhance our ability and understand what are the influences in children's health we don't know about yet.

>> just one final question. your congressional justification also states that ithe ncs-a wil be starting in 2017 and this could drive its direction significantly. when will that assessment begin and who will be involved in doing it? >> we'll very much count on our advisory group being put together. in fy-'17 we will have those cohorts funded and assembled. there will need to be a coordinating center to be sure this is working in the most effective and comprehensive way. so fy-'17 will be the point at which we'll have an assessment to see whether this model is producing the data we believe it should. >> thank you. >> we'll next go to the gentleman from tennessee, mr. good friend, mr. fleischmann. >> thank you, mr. chairman, and may i say to the chairman and the ranking member it's truly a privilege to be on this committee. when we see what the nih and the related agencies are doing, it's

tremendous that we see the great cooperation and efforts made in this cra this critical subcommittee. dr. collins, let me thank you and your distinguished panel. again, your efforts in combatting the maladies which face us on the health front are difficult and i thank you for your successes and continued efforts i have a three-part question which will i read through in the interest of time. dr. collins, i'd like to take a moment to address the precision medicine initiative. my first question is regarding the direct volunteer portion of the research cohort. as you know, vanderbilt university is playing a leading role in piloting the direct volunteer portion of the research cohort. can you elaborate further on how that pilot program will inform the initiative going forward? the second part of my question is regarding the approaches nih

is using for recruiting people in the pmi. while i'm pleased to see nih adopting novel practices, including the use of social media to attract these volunteers i would like for you to address some concerns that have been presented to me by the scientific community. specifically can you address nih plans to interpret and understand the inherent biases the approach presents, particularly given that many people do not use social media at all? finally, is the nih working with the cchs or other federal partners that fund or conduct large representative surveys to understand the biases in the pmi million-person cohort? thank you, sir. >> great trio of questions and let me answer quickly because i know we are under a time con stroint. the precision medicine initiative is getting launched this year. many of us are working 24/7 to

get this up and going and are excited about its potential. the goal is by 2019 to enroll a million americans as full participants in a study that collects information from them. including electronic health records, laboratory data, genome sequences, reports of medical experiences and allow us to really with a very large scale longitudinal study understand what are the factors involved in health and disease. we've never had anything like this before and everybody who's heard about it is excited about the inferences we could learn from this. yes, you are right, vanderbilt is right out of the box a major part of our first launch here because they just received an award actually in partnership with google, which is now called verily, to set up the effort to do a pilot effort to recruit direct volunteers and i say "pilot" intentionally because we need to learn more about how to do this. your concerns about social media being a biased way of involving people have certainly been

apparent to us and we don't want to depend solely on that. but at the same time with a partner like google and vanderbilt working together we believe we should be able in a few months to learn more about what is it volunteers are interested in, what makes it appealing to them to join this effort, what things are they turned off by. we want to get that clear before we launch. add m admittedly, we have two different ways for people to come in to this. one is direct route, people can come in. but we're also asking health provider organizations running large cohorts to come in as our partners because they have lots of access to patients and information about them and that will be a very substantial part of the effort and won't depent on social media concerns, all of these individuals will need to be asked their permission and if they consent they will become participants in this historic undertaking. we're also reaching out to traditionally underrepresented

groups by working through community health centers with our partners to be sure those individuals have a chance to take part. and certainly we are very interested in working with nchs as we get into this to be sure the kind of data we collect will be generalizable to the population. we don't want a set of individuals so different than the pop lags at charge that we can't do that generalizing, that will be important then to talk wbt with those experts at nchs. so i guess you can tell i'm excited about this. this is something many of us have dreamed about for a decade. we appreciate congress's support in getting it started this year and the appreciation for the consideration of expanding it further next year as we really launch this thing. >> thank you, dr. collins, my time has expired. mr. chairman, i'll yield back. >> thank you very much. we'll next go to my good friend from pennsylvania, mr. dent. >> thank you, mr. chairman, good morning to the whole panel and thanks for having us up at the

nih a few weeks ago. i enjoyed that opportunity. dr. collins, i've been very involved in working on obviously the fight against cancer but including and encouraging screening for colorectal cancer. you'll see those folks today with their blue shirts. the nih cancer institute is pursuing cancer research to prevent, diagnose and treat, what are some promising areas of cancer research in this area of colorect colorectal? >> i'm going to turn to my colleague, the acting director of nci to answer your question. >> thank you very much, mr. dent, as you probably are aware, march is colorectal cancer awareness month and part of the vice president's moon shot initiative involves screening which you also were advisely involved in to try to use molecular analysis in fluids for

making this more realistic so we can have higher uptake of colorectal cancer screening, one of the big problems with colorectal cancer screening is that many people don't follow screening guidelines and it's really important to try to implement what we already know works while we are doing research to develop better tests and more specific tests. i can report to you that the incidents of colorectal cancer is going down, as is the mortar it willty as a result of the screening that we have today. >> thank you for that answer. i'd also move to the issue of superbugs. what's the latest information on how nih is working with the cdc on treating and curing these antibiotic-resistant bacteria and what advancements have been made in this effort and if you have any results you can share. >> dr. fauci? >> the nih is part of a

multiagency approach towards the addressing of the problem of anti-microbial resistance which comes from -- right from the top, actually, from the white house which had an executive order and a combatting antimicrobial resistant bacteria, or carb, initiative of which the nih is a major part. the cdc is involved in surveillance and detection and providing the guidelines for the use of antibiotics. the nih component is the research component of that and in that regard we're responsible for determining at the molecular level the basis of the emergence of resistance, number one. number two, to do early screening for new types of antibiotics. there has been recently the tech sew back trin antibiotic which is a soil antibiotic which is going to open up the door to a whole new class of antibiotics that are not have any resistance

to gram-positive microorganisms, particularly methicillin resistant staff aureus. we have a clinical network that we've built years ago for hiv/aids to test promising compounds and then finally the most important issue about all of this is diagnosis. in order to circumvent the concept -- not the concept but the issue of anti-microbial resistance, you have to make the diagnosis right on the spot and we have been working on sensitive point-of-care diagnoses not only to determine if you have a viral infection versus bacterial infection because those are the biggest offenders is the prescribing of antibiotics for a disease that isn't even a bacterial disease and that's one of the things we've been working on. but also in a particular point of care kit to be able to determine exactly what the resistance profile is. you put all of those together, together with the cdc and that's

a rather comprehensive program. in addition we're part of the program of the prize. we have a $20 million prize that we the nih is sharing $10 million of that with barter, the biomedical and advanced research development authority at the department level in order to develop a sensitive diagnostic to do what i just described. >> thank you. thanks, dr. fauci for that. and finally i want to mention in my remaining time i know that the nih funding through mandatory spending has been raised. we're all concerned about it and the -- and i'm concerned there's a decrease in discretionary funding in nih and an increase in mandatory funding which is going to be problematic. last year we did the $2 billion increase in discretionary funding, this will create a funding cliff for nih, how will nih be impacted if the authorizer don't act to provide mandatory funding?

>> well, it would be devastating if we were to lose a billion dollars. [ laughter ] . chairman coal asked the same sort of question at the outset of the hearing and i painted a pretty gloomy picture and it was not just because i was feeling glo gloomy, it's because it would be devastating. we would lose a thousand grants that would otherwise have been supported we would have done terrible damage to the momentum that's been started here in fy-'16 thanks to the congress. it would be a terrible step in the wrong direction comparable only to sequester in terms of the harm it might do. >> that was a very sneaky way because you knew i would like that question. very smart. >> anything to suck up to the chairman. >> well, we'll next go to my good friend from idaho, mr. simpson. >> thank you, mr. chairman, and

thank you all for being here today and thanks for hosting us out to the nih a couple of weeks ago, i always come back from there, i've been out there several times over the years i've been in congress and i come back both amazed and inspired. it almost makes me feel guilty of having you all come up and testify because you have much more important things to do than testify before this committee. but obviously getting out what you do and what nih does is part of what's necessary but as we took a your, you took us around and visited some patients, a young man and his wife, the young man had melanoma and you talked to us about the treatment he was getting and so forth and so on and what you were trying to accomplish and somebody, i can't remember which member it was, asked a pretty simple question that i'd like you to

respond to for the record. and that was what did the government shutdown do to you? most people see it visibly as, gee, you didn't get into the national park or something like that, go next week. i know you traveled a long way, etc., etc., etc., but it's not life threatening. what did the government shutdown for 16 days do to you and what happens if that occurs again regardless of whose fault it is and we could argue that from now until the cows come home. >> i've been at nih for 23 years. those 16 days were about the darkest that i can recall ever going through. the laboratories where graduate students and post-doctoral fellows and other remarkably talented scientists were working, were all dark, we had to tell everyone to go home. they under threat of criminal prosecution if they went to campus. experiments that had been

undergone for several weeks were ruined and had to be started over again. but our largest research hospital in the world also very much affected by this. we were allowed to continue the care of patients already there but not allowed to admit new patients during the 16 days, those were people who planned to come to nih, their last chance, many of them, we are the house of hope for people where yesterday cal research is needed because there's no answer of what afflicts them and we had to turn them away, hundreds of them and i personally had to oversee that. the only exception was people in imminent danger of death and we were allowed to have a few, one or two or three per day, with very high-level approval in order to do that. people couldn't understand this, how could this be that something like this could have happened. so appreciate your asking the question, i hope and pray we will never go back to that situation again. it was very hard to preside over that kind of dark 16-day period

and full government about the government. appreciate the answer because it's the real affects of what happeneds that people don't see out there, theek see the obvious, trash didn't get picked up on the way to mount vernon and stuff by the park service or whatever. they don't really think about the life-threatening implications of some of these decisions that we make that we make too light heartedly frankly so appreciate that answer. i could ask about other stuff you have going on but i'm not smart enough to ask it what i would say is appreciate this plan you'd given and i encourage t people to look at the last page. interesting, think of the work being done at nih, it's the best-kept secret in america and in washington, that's the good

news and the bad news and we need to get the american people to understand what goes on at nih and how much research is done at universities and programs are funded by the taxpayers so that they know what they're getting in return for the investment they're making and, quite frankly, we're politicians, we respond to the public and when the public demands that we invest in these types of things, that's when it happens so so appreciate y'all being here today. i'm sorry i've wasted your time instead of doing the important things you, do thank you, mr. chairman. >> i don't think my friend wasted anybody's time and i think that's something that needed to be heard broadly and appreciate him doing that. with the consent of the committee we'll move to three minutes so we can give as many people as possible an opportunity to go but not before mr. ridgel gets his full five because you finish out the first order. in the second round you get three minutes. you'll get five. >> thank you, mr. chairman.

i regret i wasn't able to be here at the start. i was at another hearing. dr. collins and the full panel, thank you for being here. we appreciate the good work you do. i have a little window into i guess growing old because i've been blessed by two parents who are still doing well at 93 and 88 and i speak to them every week and there's a sad part, though because they'll generally take me through some of my childhood friends' parents growing up and they'll walk through that so many of them have alzheimer's. and i knew them growing up and that's my little window into this profound challenge. we've done a good job i think generally of lengthening life but the quality of life side is lagging a bit and as it relates to alzheimer's, and i don't have all the quantitative data that i want, i'm working in that

direction but i think that we've increased the funding sharply on a bipartisan base which i say i think is a win but i wonder and is rel with this that even though we here in a great fiscal stress and that has my full attention, it seems to me that this particular area warrants sharply increased funding. i mean, just as a major national priority for a host of reasons. and some of them in all candor are economic, just the fact if we could get ahold of this so would you comment on that, please? and also how much funding could we -- in a perfect world if you could have more -- at some point you get diminishing returns, you can't put it all to good use. you haven't had that problem yet but how much do you think you could absorb and really leverage the dollar and get the most out

of it? i want to give you time to respond? >> i'm going to ask the director of the national institute on aging and our lead on alzheimer's disease to answer your question. >> well, thank you for the question it's certainly true that just about everyone has had their lives touched by loved ones, family members who suffered the alzheimer's disease and the great success of the biomedical kp biomedical enterprise, the projections are unless we're able to intervene better there will be more and more of this. so it's an area among many which is in dire need of further research and support. >> in terms of the very direct question about whether a given level of funding can be wisely used, it's a critical question. it's not enough to have an urgent public health imperative. we have to have confidence that there's a scientific opportunity behind it. one of the opportunities to test that has come with the congressional requirement of nih to deliver a bypass budget each

year which asks us to estimate the degree of increased funding that would be needed to maximally pursue an efficient spending in support of research towards the goal and we've taken this very seriously. when we've composed that bypass budget which was released last july for the 2017 budget we began by convening groups of experts last year. a summit of several experts told us what the opportunities were, what the priorities were. we translated that into milestones all of which are available in as much detail as people would like in an online database. and this is what we could accomplish with a level of funding we could use in fy-'17. we knew when that budget was submitted there was a boblt that accelerated funding could come in 2016 but we were not sure and thanking you ever so much for the fact that money was forthcoming. what that money allowed us to do

was carry out the thoughtful plan accelerating what we proposed could be done with increased funding in 2017 and using in the 2016. in july of this year we will be forwarding francis collins on behalf of the nih the fy-'18 bypass budget this appropriately calls us to do what you're canning, too account for what level of research could be done to accomplish what we can ensure that we can have research supported efficiently without compromise in quality with the resources available. >> so within nih -- i think i've got 20 seconds left here. there is i'm sensing here just a true recognition that this -- not to the exclusion of other diseases and other things afflicting us in our human journey but this particular challenge is getting increased recognition as one that needs to be addressed and dr. collins perhaps you can close it out here.

>> if i may, i think we are not limited by ideas about interventions that might be successful. we're not limited by talent of scientist scientists from basic to clinical who are fired up. so resources are much appreciated and we have nowhere near hit the point on what to do with them. the bypass sbugt a great way to see if what resources are available the cost of this economically over $200 billion every year. >> thank you all, thank the chairman for the additional time. >> thank you and we'll move to three minutes and i want to add parenthetically, it was extraordinarily help to feel this committee to have access to that kind of data and our decision making last year so i would encourage you to continue that ch that. as you know, dr. collins, i have a particular interest in native american issues and just quickly i know you look at particular

populations and not everybody is the same, there are gender differences, racial differences, all sorts of things. can you give us an update on what the nih is doing specifically to address native american health issues? >> we're very concerned about all populations in the u.s. and american indians are a special group in terms of their history, their culture and their tribal sovereignty which has a major effect in terms of participation and research that we need to be very respectful of and we aim to do that in every way. we've actually just at nih thanks to the leadership of my principal deputy initiated a tribal council advisory committee, is bringing representations of the american indian community to nih to listen carefully to what they see as the priorities we should be focused on and to have a chance to engage with them in topics like precision medicine initiative and there are sensitivities there,

particularly about what kind of information is being derived about ancestry, what kind of access to the information will be provided to people outside of the community. there have been experiences in the past that american indian communities have gone through that causes them to be somewhat less than completely confident that researchers are always working in their best interest. so we really need to understand that. in that context i think we do have a number of important programs that have been ongoing for a while i think of the strong heart effort looking at heart disease for instance in indian country that's been conducted by the heart lung and blood institute and on particular project that i just recently read about that we're supporting which is aiming to deal with high risk pregnancies in the native american community and particularly providing resources to women who are about -- early in their pregnancy about how to maintain situation that will result in a

good outcome with a very impressive outcome of that particular pilot project that's now been implemented across many different tribes across the u.s. so we're always looking for ways we can do research that is acceptable and embraced by the community but very sensitive to the special nature of those concerns in those communities. >> thank you very much for that and appreciate it very much in the interest of time i'll move directly to my good friend, the ranking member of the kmul committee. >> i'm going to talk very quickly, mr. chairman. first of all i want to say, dr. collins, your seven years of service have left an indelible mark and i hope you continue your work because we really appreciate you. thank you. secondly, even the lab rats who are male have been a great laugh getter at cocktail parties, but it's really serious and i hope that will continue because it's unacceptable.

third, dr. volkow, appreciated dr. harris' comments. i don't think the majority of this people in this country understand the serious impact of marijuana on the brynns 12 to 18, 18 to 25 and i hope you can be aggressive in getting this message out and i thank you, dr. harris and lastly my friend dr. fauci, zika vaccine we know the seriousness of dengue, we know the serious of chikungunya and i wonder if there are any seconds left whether the zika vaccine, they all come from mosquitos, same areas, will certainly have an effect on chikungunya and dengue. >> well, thank you for the question mrs. lowy. we have a vaccine for dengue, one that's been approved in mexico and the philippines and brazil. it's not as effective as we'd

like it. it's about 67% effective. the nih started in january a phase three trial for dengue in brazil in association with an institute there. chikungunya we have a phase one good vaccine that's safe and that induces a good response. we have had triple, which i don't think is going to have much more trouble, in getting pharmaceutical partners to come in with us for the advanced development, i think the zika outbreak has shook the cages because we're having pharmaceutical partners interested in coming in with us with chikungunya and with zika. that's the advantage i have had with zika. i've said publicly that although there are challenges, we need a zika vaccine fundamentally to protect pregnant women because those are the most vulnerable. if you get infected during your

pregnancy there's a disturbing percentage of fetal abnormalities. we will start a phase one trial likely in september of 2016 based on the expertise that we have developed literally over a decade or more in working with these vaccines and i want to thank you and the committee for supporting the work we've been doing on our ability to respond rapidly to emerging infectious diseases. that's what we've done. we have six candidates in queue. the one that's the furthest ahead, we had a meeting three or four days ago with the fda to plot out the face one trial that i mentioned that would start in september and then the transition into a phase two likely by the beginning of 2017. how fast we get an answer will depend on two things -- a, how effective it is and, b, how much infection there is. so paradoxically, if there's still a big outbreak in dweefb, we will get an answer more

quickly. if things die down, though it will be good for the public health, it may take longer to get an answer but we are very much on top of the vaccine development. >> and i just want to say, mr. chairman, appreciate your leadership and our ranking member and the whole committee in getting the extra $2 million and appreciate this extraordinary panel and all the work you're doing and i look forward to working with you so we can say the chairman of this committee has doubled once again in a bipartisan way money for the national institutes of health because i can't frankly think of a more important investment and thank you so much for all the really important work you do in your leadership. let's do it, mr. chairman, we'll go down in history. [ laughter ] thank you. >> are you advocating for my budget or just pressuring me?

[ laughter ] >> a bit of both. >> little bit of both. with that we'll go to my good a friend mr. simpson. >> they've already started timing and i just barely got -- quick question. the cancer moon shot the president announced in his state of the union by the way which i think was great, i support it. republicans don't always criticize everything the president does. i think this is a good start. it's government wide. i chair the energy and water development subcommittee, the department of energy is going to have a role in this also. they're getting more and more involved in biological sciences and stuff and when i ask them they say, well, you know, we were originally involved in the biological sciences because of radiation and the cancer caused by radiation from weapons developments and other things over the years. what's the relationship between

nih, the department of energy? what are we looking at in the future? what will be that relationship, do you know? ? >> i'll start by saying there is a task force at the highest level it was appointed to support this effort across government with the vice president's leadership and that very much includes the department of energy as well as fda, nih, a strong input from nsf and a variety of other parts of the government involved here, including commerce because of ipi shoes but i'll turn to dr. lowy who could tell you something about a direct involvement already ongoing between doe and the cancer institute. >> can you also talk a bit about the radical isotopes with canadian reactors shutting down? are we going to have access to the medical isotopes necessary? >> thank you, dr. simpson. first with regard to the

department of energy we have initiated very recently three pilot projects request them in cancer research and they will form a key part of the moon shot and we are continuing to have ongoing extended discussions with people from the department of energy, including secretary moniz about further extending this because largely they have extraordinary computing power and also machine learning which is able to do things that really can -- that would be extraordinarily helpful in the cancer research area. given the time, let me get back to you for the record in terms of the isotope issue, thank you. >> thank you. with that we'll go to the ranking member of the subcommittee and my good friend from connecticut. >> thank you, mr. chairman, i'm going to talk fast. on antibiotic research i just

came from an a.g. committee hearing. i will say that to you, 70% of antibiotics sold in the rust bought for livestock production. there's industry guidance today that's voluntary through the fda. i don't know what collaboration you have with usda, with fda but it's critical, we should not be in silos here. you talked about 23,000 deaths. if we know what's going on, let's get their research, your research and look at how we can cut that number in half as you said last year dr. colins that we could do. so it truly is unbelievable and it's voluntary. we need to think about guidance -- not guidance, voluntary guidance, we need to think about how we tell people that -- and the pharmaceutical companies in a mandatory way in my view. let me move to the precision medicine initiative. i was alarmed by a "new york times" article that failed to

identify personalized treatments for breast cancer patients. dr. lowy, dr. collins, what's the clarity on this issue and guidance to practicing breast cancer physicians or patients? >> thank you very much. i think this area exemplifies the strengths and the limitations that we have of any minute cal test. you do a clinical test and for some people it's enormously helpful and for other people the results are ambiguous. the genetic tests that we have can be enormously helpful in pointing people with cancer in the right direction in terms of treatment but not for all of them. >> is it accurate in terms of -- the success has been in other areas other than breast cancer. the breast cancer a specific

disease that is not responding to pmi or am i -- or is this article off base but help us? >> there have been specific inhibitors, for example, herceptin, which was the first targeted inhibitor was specifically for breast cancer and egf receptor inhibitors so there are specific inhibitors for breast cancer. the problem is that when you get an abnormality, not all of them are clearly actionable and not all of them will be responsive. >> i would like to continue this conversation and i might ask you to look at the "wall street journal" this week. this is bristol-myers squibb precision medicine. i'd ask you to look at it and tell us what bristol-myers squibb is talking about when we're trying to move in this direction. i've got four seconds left. all i would just say is, dr. fauci, if -- one i want to make

sure that any vaccine that we deal with for zika is going to be available and affordable for people, this is the reasonable terms issue but secondly i would offer my view i think it's critical for us to deal with a supplement supplemental emergency resourcesed for the to address this issue and this problem. you are right, i will tell you that we are now sending blood products to puerto rico in response to a zika outbreak. what happens when we are looking at a baghdad supply that is potentially going to be difficult or people are not going to understand the safety of a blood supply with regard to zika and what kind of problems that will cause here in the u.s. and let me tell you, american women are not going -- they are going to be outraged if we are

not doing something about them and about their ability to be pregnant and bring a child to term. so thank you for the great work you're doing in this area. i have another question but that's okay. [ laughter ] >> i'm not sure that was a question. >> genetically modified mosquitos. genetically modified mosquitos. >> i'll ask the gentlelady to take that one for the record because i want to make sure our remaining two members get an opportunity. with that, mr. harris, you're recognized for three minutes. >> thank you very much. doctor, let me continue and follow up a bit because the marijuana use and full legalization is a huge issue. we have a rider that affects the district of columbia on our appropriations bills usually and let me just -- you were coauthor ago 2014 review article in "new england journal of medicine," pretty prestigious medical

journal and let me review some of the statistics in it and just confirm that these are still true. with regards to marijuana addiction, although the overall rate is around 9%, if you look at young users or daily users it's higher with young perhaps as high as 17%, daily users 25% to 50%. is that still the state of our knowledge? marijuana dependence, though can be much higher and depending upon dash because it depends on other factors as well. it can be twice that, 20% in general use. with regards to the gateway theory because this is controversial, my best understanding is there's some reason to believe in other studies that potentially there is a getway -- it is a getway drug but it's not clear whether that's true in humans. is that true or are we developing an understanding that it is a gateway drug to other addictive behavior. >> there is evidence that, yes, marijuana changes the sensitive of the reward centers of the brain to other drug which is provides a means by which you

become more vulnerable for addiction. but you cannot necessarily directly translate into humans. the issue in humans is still being investigated. but it's not settled science it's not a gate way drug in humans? >> all of the epidemiological studies show it is a drug that frequently precedes addiction to other drugs. >> and is associated with or causal. i understand. i did animal research, i understand you can't always extrapolate to humans. finally, which was interesting to me, when you look at the effect on school age children and you're not careful in how you control the access to children's school that it impairs critical cognitive function for days after use it was interesting and that was stated in the article. is that a fact? >> that has been replicated by independent investigators. >> so if we don't write the laws carefully and you allow children in school to access to it that critical cognitive functioning can be impaired for days.

this is in the setting where we want to have children go to school and learn and be cognitively functional. from a scientist point of view would you urge jurisdictions that are looking into fully legalizing marijuana to exert extreme caution in taking that position at this point? >> i basically ask people to look at what the data is telling us. we have seen consistently that the most devastating effects of drugs in our country are from legal drugs not illegal. not because they are more dangerous but the legal status makes them more available and more likely to expose more people and explains why we have so many more adverse effects from legalization. so i always say do you want to have a third legal zplug can we as a nation afford it? >> thank you. for the last question of the day we go to my good friend, the gentlelady from california. >> dr. fauci. my colleague, congresswoman

herrera butler and i have started a new congressional caucus on maternity care to promote optimal birth outcomes for women and to highlight issues like the zika virus that pose a risk to child-bearing women. so we've been following with great interest the world health organization's finding and council regarding this disease. the committee stressed the urgentsy for research and development of the zika virus vaccine, which you've talked about earlier. but the who emergency committee also recommended both retrospective and prospective studies of the rates of microcephaly and other neurological disorders in areas known to have had zika transmission but where such clusters have not been observed. so my question is whether or not it's possible that the zika virus has been responsible for cases of microcephaly in the united states over the past three to four decades and has there ever been any tracking of

this birth defect to see if there have been clusters or increased incidences of its in the united states? >> that has not -- regard to retrospective studies. but there has been no zika virus in the united states. we know that from when we do serological scannings of what has been in the united states. there has been no sdeer canzika the united states until it has arrived in south america and the caribbean. what we have now in the united states is over 190 cases that have been imported, mostly people who have been in the caribbean and south america who were infected there and came back home to the united states. what we haven't had is local outbreaks similar to what we did see a few years ago with with chikungunya in florida.

there's a very important surveillance capability which will tell us the negative answer to your question, we haven't had zika in the united states. but will also tell us if and when and, unfortunately, it is probably likely that we will, as the summer comes, see mini-local outbreaks, particularly in the southeastern part, gulf coast states, texas, florida, because the mosquito, which is the major transmitter, is in that area of the country similar to puerto rico, similar to south america. finally, what we do have in south america are cohort studies to take a look at what the fundamental baseline level of microcephaly is and what the relationship is to the infected people with zika. a study came out -- two studies. one came out a week ago showing that if you looked at zika infected women who were pregnant and pregnant women who were not

infected with zika in brazil, there was a very disturbing 29% of the zika infected women had ultrasound dopplers indicating abnormalities of the feature, which is very disturbing, which is the reason why we feel very compelled to be able to get a vaccine to protect not only the people in south america and the caribbean but if necessary, if it comes to that, in the united states. >> let me just give you the personal reason and personal interest in this particular area. my grandson was born with microcephaly. this had to be probably over -- about 12 years ago. as a result of that, both my daughter-in-law and my son took every test imaginable to find out what the cause was, especially since they planned on having other children. and they could find nothing. none of that research. i'm just wondering, we're trying to figure out what possibly

could have been the cause. >> there are a number of causes. that's an excellent question. very important question. because people sometimes get the misimpression that mie m microc is only associated with zika. but microcephaly has been around forever. it's associated with something that happens, usually in the first trimester. that can be a viral infection, cmv. that could be any of a number of viral infections. that can be fetal alcohol syndrome. that could be a variety of things that interfere with the developmental process. usually takes place concentrated in the first 15 to 20 weeks of pregnancy. although, we do know now from a study that even women who get infected in the second and early third trimester can also have abnormalities in the fetus. may not be full-blown microcephaly.

the range of abnormalities are disturbing. which gives us fuel to the fire of getting the vaccine. >> another thing to mention is genetics. it was hard to nail that down. now that we have the ability to look at the genome sequence and many centers are doing that, we're uncovering causes of microcephaly due to dna changes that we didn't know about. that's wonderful. >> thank you very much. dr. collins, let me begin by thanking you and your colleagues for not only your appearance here today but your accessibility to all of us when we have questions. we appreciate the wonderful work that you do. this may be -- we will have plenty of opportunity to continue to work with you. may be your last appearance before this committee. that will be a decision i would suspect of a new president of the united states at some point. but we hope it's not your last appearance here, quite frankly, just speaking for myself

personally. i again want to thank you for the exceptional leadership that you have shown at the nih for a lifetime. that would go to all of you, quite frankly, of putting the health and security of our people but all people as your principal goal in life. it's quite remarkable. you are all very, very distinguished in your own fields. to see the manner in which you collaborate together and work across disciplinary lines and institutional lines is really very inspiring. so we again just appreciate the values that you show and the basic and decent humanity that each of you exhibit. it's no surprise to me that it's the nih that tends to bring this committee together where it puts aside partisan differences, ee d ideological differences to try to advance and support the splendid work you are doing.

i'm sure that will continue. we will have other things we will fight about. but this isn't going to be one of them. this is going to be one of the areas where we work together. frankly, where we protect the discretion afunding you got las year due to the bipartisan efforts on this committee. we try to build on that. frankly, we're hopefully, dr. collins, we can go to the sunny question i asked and that is perhaps do better than even the president proposed, certainly as proposed a generous increase, but if we can put additional means in your hands, then i know on a bipartisan basis we will want do that. thank you. we're adjourned. >> thank you, mr. chairman. you speak for all of us. thank you. >> thank you.

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