an opening, and i tried awfully hard, and they think i succeeded, at keeping my own opinions out of these books. they are not my stories. they are the stories of the soldiers and families, but i think it's pretty fair to say that if i had a kid who served and then came home and needed help, and i learned that there were these three options available, i would want, but expect the very best for him. it seems like the least, the least we could do. but again every thing is on the other hand. on the other hand, the four month program is not a broad scale workable model. ..

>> toward as much as they could rer as what happened before that moment or the accumulation of these moments. you know, go back to the beginning. go back to your childhood. not as a trite way to excuse what you might have done, not to say that everything depends on the patterns of your life, but his thinking seemed to be if you

can understand by learning about yourself enough to know who you were in the moment before the traumatic event, then you'll have an easier time understanding how you behaved in the first controlled moment you might be more -- maybe not forgiveness, but at least there's some understanding built in. >> so that seemed, you know, is that perfect? no. but for what's available out there, seemed like a pretty good shot. >> yeah. i just wanted to make one quick note. i'vem= interviewed a couple dozn ptsd survivors, male, female, war veterans, rape survivors. one of the most powerful therapy is the yoga as an alternative therapy because it helps change, the hypervigilance that's associated with ptsd where you're always aroused, you're waiting for an attacker, and soldiers, veterans suffer from that a lot.

yoga helps people be on an even keel with their body and lower the stress hormones, be in a more stable, centered state. the va is spending money on this. they do yoga research all over the va centers, and additionally, a lot of the eastern flossty, i took part -- philosophy. i took part in a mantra repeating study which i didn't find helpful, but a lot of people did. a lot of the classical, psychological theories are incredibly powerful, but they're kind of weird. it's a little strange to take a bunch of marine grunts and say, you know, now we're going to put your leg behind your head. [laughter] that doesn't go over well at first, but particularly in southern california where yoga's common, there are tons of teachers out there. i have friends at 29 palms, and i think those are extraordinarily effective, and

we need to informs more in -- invest more in those. they're harder to sell on the floor of congress, but yoga's super powerful. i interviewed one rape victim for several hours, and she said it saved her life. it was a huge -- and she went through exposure therapy, ask it did nothing for her. so i think you have to expand your definition of what therapy is, basically. >> this just occurred to me with a little lightbulb over my head as david finkel was talking that, for me, no doubt the book i have written about tim is exactly the process that i describe. i standard with his childhood and try to understand how the patterns of his life could have led him where they did. >> well, it's storytelling, right? >> yeah. >> in any form. >> yeah. >> there's this old thought, i don't know, whoever said it first said it far better. i'm just going to jumble it. but in the -- life, basically, so absurd and chaotic anyway, the only chance you have of making sense of it and living an

optimistic live is to story my things -- storify things. whether you're writing a book or trying to understand a life, there's certain moves we have to get to try to gain control of it. now, is that cpt? i don't know. i saw, i saw some value with some guys, not everybody, but some value in what cpt was doing. the bigger rob i saw was -- problem i saw was just, oh, my god, the overreliance on medication. i mean, there's one guy, he was taking something like 40 pills every day. and it's, they weren't all separate. it was a thing where so you're depressed, take this one. oh, so you're still depressed? take this one in addition to that one. anxious? i mean, this is not news. it's just -- but the overmedication was stunning, and

a lot of the reason for the overmedication is because of the underrepresentation of people especially in areas where soldiers tend to come from. there aren't, there's not an abundance of psychologists and social workers and therapists and qualified counselors able to help. so guys show up ask they say, all right, we're working on it, here, take this pill, take this pill, take this pill. generalizing, obviously, but it's a significant problem. >> will we have about ten minutes left. i promised i'd open it up to audience questions. please step up to the microphone here. >> used to think ptsd dozens of times, but you never explained what it moment. >> post-traumatic stress disorder. >> as i understand, ptsd is many different things, with but it is, first and foremost, a

psychiatric disorder category involving intrusive symptoms like flashbacks and hypervigilance where you're over, you're too switched on, you're expecting an attack at any moment, and that can alternate with emotional numbing where you feel numbed out, and you feel nothing. and there's about 18 different symptoms, but those are the three basic symptom areas. intrusive symptoms which can include nightmares and flashbacks, hypervigilance and just being totally angry and waiting for an attacker and then just being numbed out. so those are -- that's how i understand it. but youáxñ have to understand is a long story, but ptsd was invented, basically, in 1980. but it has a history that extends all the way back, you know, in all of human history. and, you know, jonathan shea, the gentleman who wrote in her book, finds it in the iliad and odyssey. so it is in some ways kind of an immortal condition, but it does

tend to be ip frequented by the culture -- inflected by the culture. civil war veterans did not have flashbacks, they tended to report being haunted by ghosts, so there was more of a supernatural inflection to it prior to the invention of film and television. flashbacks, as we call them, kind of grew out of the film culture and also the lsd culture of the 1970s because that's where ptsd came from, it came out of the antiwar movement and the left. >> sir. >> i just wondered what you thought about the tact that it seems we've gotten away from the point where they think about the human cost of going to war, they don't take that into consideration. in the past the united states was involved in wars, obviously, kind of unavoidable, the two world wars. and i remember growing up i had a babysitter whose husband came home from vietnam, and i just remember -- it struck me when i started reading about all the iraq and, you know, veterans. i remember the thousand-yard

stare that he had when he would just sit in his chair and just stare. and it struck me that, you know, like how did we forget this was happening to people when they came back from war and not be prepared? >> when we talk about human cost, it's one of, it's one of those phrases that falls very easily into an account of the war without really thinking about what it is. one of the things that i think about is 22 veterans a day means 22 mothers a day. >> so when, i think here's a way to think about it, and forgive me if i'm being obvious. not, these have not been popular wars, and it's not like a lot of americans have a particular stake in these wars. it's an all-volunteer force, it's a professional force now, and you though the stats. less than 1% of american

families have had somebody directly, directly in these wars. so it means you go to a neighborhood, you knock on 99 doors, no, not here, not here, not here. it's not like factories were being shut down to build mraps so guys wouldn't get blown up so much. these were unpopular wars by professional force in a faraway country. you don't have to care until you have to care. and this is not a suggestion in think way for conscription, it's just to state the obvious. it's not -- how do you forget about the human cost? it's not just that. nobody's thinking about the wars -- that's an overstatement. a lot of people aren't thinking about the wars very much at all. so human cost gets to be one of the casualties of that. >> i remember as a girl in phoenix, arizona, seeing gold stars in windows in the

neighborhood, and there were quite a few of them. and one of the things that i did on memorial day was to make a big gold star and put it in the window. but, you know, that was a kind of sentimental thing to do. >> sir. >> yeah. the other appalling statistic i've heard from these wars is the number of traumatic brain injuries. i'm sure there's some overlap between that and post-traumatic stress disorder. wonder if any of the panelists could comment on how many tbis there are and some, give us a quick little, you know, in the time allotted background on that as well. >> i don't feel, actually, qualified to talk tbis. you are correct in the sense that if you imagine two circles of symptoms, the two circles overlap to a large degree in terms of the symptoms of ptsd

and tbi. i think, to be honest, i think that we're just now in the opening phases of a campaign of understanding what tbi really means, because the brain is, has more connections in it than there are stars in the known universe, so we don't fully understand what happens when you give, when someone experiences -- i mean, i lived through two ied attacks. i don't know, i didn't lose consciousness, so they weren't profound injuries, but there's hardel to say what the long-term impacts of those are. interestingly, the researchers that i've spoken to look at the nfl as being a very useful ask very analogous database. they look at, and you look at, you know, locally, look at what happened to junior seau. he experienced concussion after concussion after concussion. one of the units i was in, one of the sister units that david finkel was embedded in, you

had -- they generally had a four-ied rule. if you had three concussions, they would send you home. so there is, i think, a general awareness of it. i don't think the neurology, i think we're just getting into the basics of our understanding of it. it's almost like, you know, the space program in the '60s. i think we're just figuring out the fundamentals of what's at stake there. interestingly, the one thing i would say there was, if someone is seriously wounded, there is this weird effect. if you are wounded and you lose consciousness, the likelihood of you getting ptsd drops by 50%. so there's something that happens in the immediate six hours after an attack or a wounding that changes the way the memory is stored. and neuroscientists have a pretty good handle on that. in kind of a paradoxic way. if you suffer a fairly profound traumatic brain injury and you lose consciousness, psychologically you are in a

slightly better position, if that headaches any sense. that's -- if that makes any sense. i'm not sure how to describe it. i'm not saying it's like, good for you, you had a tbi. [laughter] but there is, it shows how -- and we don't know why that is exactly, but it just shows how complicated and how delicate a machine the mind is. i don't know if you can add to that, david. >> no, there's some overlap. you're right, of course there are a lot more tbi cases, traumatic brain injury, and a lot of it has to do with the fact that so many people in other wars who would be dead are not dead in these or wars because of better concern in these wars because of better equipment. these are low blasts, they tend to come out. you get your brain rattled, you lose consciousness for a bit, and you've got, you're rearranged, and you've got some things that are chartable to deal with. it's funny, on the whole hire

hierarchy of these things i see guys with ptsd sort of wishing for tbi because at least there could with a brain scan to show, oh, look, here's proof. there actually is something physically wrong with me. and guys with tbi so wish they were missing a leg so they could say, oh, look, there's something wrong with me, i can believe this. all of that gets back to the whole stigma of the psychological wounds even if there's something organic underneath it. the inability for a lot of these rough and tough guys especially to, first of all, believe that something may have happened to them and then go forward from there. >> yes, sir. >> so a lot of the stuff you talked about and, like, the treatments, like, have to do with a traumatic event. i'm curious, is that the majority of cases there is a traumatic event that it can be traced back to, or how often is it, it just develops and there is nothing -- >> could be one thing, it could

be an accumulation of things. what janet was referring to, people are starting to pay more and more attention to that. and let's not pretend this only exists on the military side of the equation. i mean, there's trauma in the civilian world as well. the, to me, you guys might disagree, but to me the commonality here is once something happens in your life whether it's a single event or an accumulation of things but there's some -- it's not just that just rattles you down to your bones, you know, what do you do then? you either succumb to it, or you get busy trying to recover. and whether it's tbi or ptsd or civilian or military, as one of you guys was saying, you know, life comes with trauma. and trauma necessarily comes

with attempts at recovery. that's what we do. and to get back to an earlier point, the whole idea of we have to be careful here because of the whole notion perpetuating the stereotype of the rogue soldier and so on, the fact is there are broken soldiers from these wars. it doesn't mean they're going to be forever broken. probably most of them if you look)%p through history won't b. but that doesn't mean you dismiss in this moment as, you know, other wars were tougher, we've always had a version of this, you know? people have kind of figured out themselves, well, we don't have to act as we acted before. we can advance and act with more compassion and understanding than we have in the past. >> it became one of the legal issues this the benefits trial -- in the benefits trial for my son whether we could point to a particular incident that had caused trauma. and we couldn't.

there were three possibilities of times that he had been in trauma, bun of his symptoms -- but one of his symptoms was that he wouldn't talk about it. and i think that is a frequent symptom, and certainly something we learned about the second world war, that vast numbers of people who came home from the second world war were vastly changed but wouldn't talk about it. because as part of the soldier mystique, the man of few words. and clearly, what helps is getting them to talk about it. in many cases. >> miss? >> hi. you mentioned, it was mentioned on the panel bush and chain think, and i think even rumsfeld. what i wanted to know is what the panelists are doing to prevent the united states from going into another war, particularly ukraine where we contributed to overthrow the government, syria which is heating up again and all the

other places that we're meddling in. what are we doing to prevent in this so that we don't have more discussions about ptsd and tbi and all these things? under a democratic president, by the way. so i wonder what you're doing. >> to answer your question, i guess for me i'm not specifically politically -- i don't see my role as political activism, but there is a political, inextricable political element to prks tsd in a sense -- ptsd in a sense, and i think this is where it's good to recognize that there are broken soldiers out there, because the soldiers that are suffering are symbolic of all of the suffering that went on and all the suffering that the wars inflicted. so that's -- and that was one of the original things about the original architects that helped set ptsd down and get it recognizeed by psychiatry was we don't want them, we don't really entirely want this to be a

curable condition because we must remember the pain of war, we must remember the losses of war. so from as far as how i interpret the work i'm doing now, i'm trying to use ptsd. i think it's many things, but in addition to it being a psychiatric disorder that's recognized, it's also a symbolic and a poetic thing. it's a similar poll of you can -- symbol of you can talk to someone, and you can see there is a symbol of the soldier who paid for his country that we are forced to pay, to pay for his or her treatment and to deal with their story, to deal with their testimony. so, and i think that's one of, you know, people are more interested now in ptsd than they are in the wars we just left because people are seeing their spouses and children come back with it. and so it's an issue that people are wrestling with, and i think that's, you know, i can't think of many things that would do a better job of keeping us out of fighting another war, another

stupid war than focusing on ptsd. i don't know if i fully satisfied your question, but that's how i look at it. >> i hope you're right. >> my answer would be that writers write and that the way that we try to be activists, those of us who do consider ourselves activists and unlike the journalists, i do, because of hi experience. but, you know, your question is a valid one, and the answers seem pitifully small, you know? i donate $25 here and sign a petition there. but what i'm really doing is writing. the story that i went through. >> we're out of time, but i think we have time for one quick question. >> from the trenches, one of my subspecialties at cal state fullerton's trying to teach university-level mathematics to learning-disabled students. i had my first ptsd this semester. it's a tragedy. we don't have a medical diagnosis. all it is is ptsd.

plainly, the circuits are broken. the student is tragically impaired. no medication, no adequate diagnosis. and we don't have, we have ph.d.s, but we don't have medical doctors. the tragedy continues, i'm sorry to say. >> please thank the panel for coming. [applause]#%÷ we'll all be around afterward if you have any other questions. [inaudible conversations] >> on our special prime time booktv programming tonight, we'll look at three bestsellers including lynne cheney's book on james madison, thomas piketty's capital in the 21st century, and mallory factor's book, "the big tent." that's tonight at 8 p.m. eastern. >> several live events to tell

you about this morning beginning with a speech by the iraqi ambassador to the u.s. at the carnegie endowment for international peace about escalating violence in his country. that's on c-span at 10 a.m. eastern. also at 10 on c-span3, the international institute for strategic studies hosts a discussion on the syrian civil war. and here on c-span2 the wilson center focuses on russia, ukraine and energy policy at 10:30 a.m. eastern. >> the head of the national institutes of health says a lack of steady federal funding is hurting efforts to cure diseases like cancer, alzheimer's and hiv/aids. dr. francis collins and others testified before a house committee on biomedical innovation, discussing pharmaceuticals, new technology and patient care. this is a little more than two hours.

[inaudible conversations] >> okay. thanks, everybody, for coming on time. welcome. i'm fred upton. welcome to the first of what will be a number of round tables of our 21st century cures initiative, a collaborative, bipartisan effort that aims to accelerate the pace of cures and medical breakthroughs in the united states. as my colleague, diana degette, and i mentioned in the video that we released last week, as part of this bipartisan initiative, we are going to spend the next number of months,

six, eight, nine, whatever, to review the full arc of delivery, development and delivery process to determine what steps that we need to take as a nation to accelerate new cures and treatments and insure that we keep america as the innovation capital of the world. we cannot do it alone, for sure. we need the support of and the ideas from those of you that are here today or certainly watching online. we're going to hold round tables in washington and perhaps around the country as well as we hold hearings in chairman pitts' subcommittee, and we'll solicit feedback from experts and interested parties throughout the country and with a lot of white papers and a lot of questions. and we need a lot of answers, and we need to listen. no idea is too big, in idea is too small. the only way that we're going to accomplish our goal is if we work together to join the this conversation, and we hope to

hear from you during that process. and for those of you that are watching, you can e-mail your ideas to cures@mail.house.gov. today we're going to continue our process of soliciting ideas by hosting the first round table of 21st century cures. we're lucky enough to be joined by some of the nation's greatest thought leaders in medical innovation. they are dr. francis collins, director of the national institutes of health, dr. janet woodcock, the director of fda center for drug evaluation and research, dr. jeff shuren, director of fda's center for devices and radiological health, dr. james woolliscroft, go blue is right. dr. joe gray, associate director for translational research at the knight cancer institute, oregon health and science university.

dr. andrew von eschenbach, president of the samaritan health initiative and chairman of the project fda at the manhattan institute. margaret anderson, executive director of faster cures. dr. peter uber, dr. ellengv sig, sarah despres, director of government at the pew charitable trust and jonathan leff, partner at deerfield management and chairman of the deerfield institute. thanks for being with us today. now, in order to get most out of everyone, i'm going to coop my remarks very -- keep my remarks very short. i'd like to ask diana degette, my co-chair on this effort, to say a few words, and then we're going to introduce eric cantor, the majority leader. i will say in advance steny hoyer planned to be here today, and he had a very last minute conflict. but in essence, we have the number two republican and the number two democrat onboard in terms of what we're trying to do to show bipartisan forward

marks. so with that, diana. >> thank you very much, mr. chairman. i'm very -- >> it's still fred. >> okay. thank you, fred. i'm happy to partner with you in this important effort. the 21st century cures initiative is an exciting new effort that has great potential to positively impact biomedical research and innovation in this country. the united states has been the leader in this field for decades, but now be i think we're at a real crossroads. we can either work together to improve health and medicine as we hope to do through this initiative, or we can fall behind. our effort will bring leaders in policy,ñi academia, research and industry to the table to really dig into how we can more effectively and efficiently tackle some of the complex challenges in medicine. as fred noted, research and innovation runs on a sort of cycle; discovery, development and delivery. it's in those areas that we want to focus our attention and seek

input of leaders like the distinguished leaders who are in our inaugural panel today. since we launched the effort a week ago, we've already seen tremendous interest in just the attendance today which shows the interest that we have. the questions we're focusing on will be key to beginning our work towards possible solutions to these complex challenges. first, we need to take a look at the current state of biomedical research and innovation in the u.s. what are the drivers? what are the barriers? where is the u.s. leading and where are we concerned if we're following -- falling significantly behind? second, how does biomedical research and innovation translate to improving patient care and outcomes? and better health and medicine? we know that there are pocketsover fantastic -- of fantastic progress and promising research being conducted every day across the country. what types of patients are benefiting? where can we focus our attention

to reach more patients? third, are there other countries that we can learn from? as both fred and i said, the u.s. may be in danger of falling behind. what strategies and resources are we following to excel in research and education? finally, are there concrete, viable action that is we as lawmakers can take to help advance biomedical research and innovation in the u.s.? does the nih need tools, or how can we help, and/or how can we help the fda modernize the drug approval process to take advantage of the cyclical nature of research and innovation that we mentioned; discovery, development and delivery. all of these are important questions, but they're also hard questions. i think everybody in the room and particularly on this panel today is up for the challenge. i know that we can be productive in our conversations both today and moving forward, i look

forward to the discussion, and i'm grateful to fred and everybody who's here today for joining us in this effort as well as the ebbs perts who are taking their -- experts who are taking their time. thank you very much. .. we ought to be a country that promotes the country of yours.

all of us are about access to treatment for every one. margaret, your group of faster cures hits the modern parlance. we got to get better at making it faster for us to get? hours and making few hours more of our reality. good treatment is not enough. so thank you for the emphasis, the 21st century cures initiative by the commerce committee i think will be a tremendous story of accomplishment for congress. if nothing else this congress should be known for making the right choices and setting the right priorities. that is saving human life first, promoting few hours, treatment, ultimately a win/win/win for everybody. a lot of the discussion on a whole has been about fiscal

restraint, how do you deal with limited resources. dr. collins, we had many discussions on this issue and there are i think all of us here who are active on the cancer side in terms of research, what can we do to do more? all of us want to do more but sometimes first is making the right choices with what we have and then setting about how to do more so i congratulate you on this. i would just ask, i know it is inherent in the numbers in the commerce committee to think outside the box and i think all of us sit here and talk about breaking down the barriers the way diana talked about in terms of promoting a culture of you is, spending $10 billion, taking ten years and spending a billion dollars to develop the drug and bring it to market is

unacceptable when people are dying. how do we think outside the box? it is improving fda processes and making choices, like the first step we took with the kid first research act that is demonstrative of tough choices. in the scheme of things $123 million is not the $30 billion we have going but it is a step, demonstrating we are willing to make tough choices setting priorities. i really commend the initiative here and look forward to playing an active role, however that may be according to the chairman's desire to help promote success. i thank you, the esteemed panel, appreciate your work and honor your presence and look forward

to the outcome of results. yield back. >> thank you very much. we will keep you in the loop, no question about that. i will ask former chairman and ranking member wax and to say a few words in a minute and former chairman barn and chairman emeritus of the committee to say a few words in a minute. i want to introduce the members that are here. chairman pitts is ranking counterpart frank alone on the health subcommittee. member of our leader should, chair of the republican congress, nor as rogers, a member of the house subcommittee, chairman michael burgess from the health subcommittee vice chair, castor from florida who joins us. morgan griffith and leonard lance, member of the committee as well. my friend mr. waxman.

>> thank you, mr. chairman. is important for us to figure out ways to develop q wars more rapidly. we spend an enormous amount of money in basic research of which the pharmaceutical companies take advantage and are able to produce products that are life-saving. we have got to encourage more development of medicines but we also have to make them affordable. we don't do anybody a favor if we have a drug that cannot be bought or the health care system cannot pay for so as we think about new products, new drugs, new therapies, we must evaluate them and to see if we are adding more to helping the american people and mankind or whether we are just layering on new efforts that will cost a lot more but

may not add to the therapy that people are so desperate to have. thinking outside the box, it is evident from this kind of meeting and it is interesting. i have never seen anything like it in the time i have been in congress and i will look forward to this group figuring out the recommendations to the committee so we can consider is that legislation if necessary. we all want to work with you and it is worthwhile to hear from people in us setting that is different. i don't know if we can even make a transcript of the proceedings, but any time we can exchange ideas is all for the good. >> congressman waxman is uncomfortable being to my right but it is good to be here.

we are going to show our system at its best, bipartisan under the leadership of chairman upton, and with the auspices of mr. pallone on the democratic side. our system really does work, and over the next however many months, the country is going to see america's political system and medical system at its best as we work together to decide how to take things out of the laboratory into everyday life and some of you i know very well, some of you i worked professionally with, but chairman upton is an honest broker and he is absolutely making this up top priority, the american people will see real

results, i look forward to having a dialogues and ultimately come of with some common sense solutions for cure worse that make america and the world better place so thank you, chairman. >> when we send out the invites we sent a couple questions to spur some thought and i would like to see where that takes us over the next couple of hours. we ask these questions. what is the state of biomedical innovation in united states, what does by medical innovation mean for american patients and jobs, how does the u.s. compared to other countries with respect to buy a medical innovation and how can we make sure we lead the way in the 21st century? and last, what steps does congress need to take to accelerate the discovery,

delivery cycle in the u.s. to foster innovation, bring new treatments and keep more jobs in the u.s.. a nice afterthought in terms of where we want to go. what families and impacted by something we can do here, whether it is in this country or some place else? why don't we start with number 4 first? what steps can congress begin to take? for some of you, you have been as i sat down with many of you over the last couple weeks, even a couple months, hopefully the ideas, element of that is working, you come up with some things, the listening audience as well, the few hours, the way people can weigh in, looking at those so begin to process them and dr. collins, we will start with you but then we will have a discussion so feel free to it use the mics and let's go at it.

thank you for being here again. >> thank you, mr. chairman and ranking member degette. this roundtable is really rectangular and so many members of congress in both parties represented here. i thought to myself i have never seen anything like this, my 20 years were not that informative but when mr. waxman said he had never seen anything like this, this is a special moment. much credit to you for convening what i hope will be a series of conversations so to try to answer your question and not go on too long about it. what most desperately needs in order to continue what has been the most successful story in biomedical research the world has ever seen is a steady, predictable trajectory of support. we have not seen that over the

last ten years. we have lost 20% of our purchasing power and that has put the system under enormous stress distress. it has cost jobs because we support 438,000 jobs that were trimmed, but most importantly and most worrisome for the future it has caused a great paul for young investigators who are our future and if we want to see innovation continue at the levels that it could need to have the confidence that there is going to be a path for them that their dreams are possible to pursue. we are not lacking in that or the ideas, this is a unique and remarkable moment in terms of research potential. we are in a situation paradoxically enough where this remarkable scientific opportunity is a distinct mismatch with the ability of investigators to take risks and

do the kind of amazing science that we in america have been famous for and are capable of now. is also perhaps an occasion where we are missing out on the return of the investment that might be there and i want to mention that because your questions reflect an interest in that. just today, a publication did an analysis of the economic returns of the women's health initiatives, an effort which was started 20 years ago which nih than $260 million on. the return on that is 140-1 in terms of what it taught us about women's health, the ability to put that into practice and save lives, pretty amazing consequence of that. in terms of where we are going, the innovation opportunities, we are extremely energized by the kind of technologies that are possible and wishing to have that unleashed the being held back when it comes to things

like personalized medicine where you do dna sequencing on a ship this size, the size of a postage stamp. i brought with me a project jointly fda and data, this is a human kidney made up of human embryonic stem cells that are placed into a particular arrangement using 3d printing that you can study human kidney function derive from an individual in a very reproduceable way. extremely exciting technology but again things that we are not pursuing at the level we might. we are in fact trying everything we can to try to use this crunch as a motivator for creative solutions, working with industry, something like the accelerating edison partnership which you have commented on which brings together the science in the public and private sector on alzheimer's disease and diabetes and rheumatoid arthritis, working in other ways to try to cut down that ten year period of trying

to go from an idea to an improved therapeutic, and we are pretty bullish about the potential going along with what leader cantor said, we're just as excited not curing things as you can imagine. we wanted your alzheimer's disease, we want to cure cancer, we want to cure hiv and all of those are potentially within reach. the current system isn't working. and i age wasn't broken ten years ago, ten years of loss of purchasing power have started to break it. if we had a chance, to recognize this is not something that is spending, this is an investment that pays rewards for each human health, for the economy, everything the government does well. recent analysis by economists indicating may be the most important entrepreneur in the american system is the federal

government and yet we have not allowed that on for for nor to be what it could. bottom line, if we could have the confidence of a stable trajectory for support, that would mean the world to an enterprise which is currently flagging. as a point of the real consequence of this, don't know if you saw usa today in the last couple days describing a typical situation of a brilliant young scientist in michigan who is at the top of his fields, who should in any other era be fought over by ten institutions in the u.s. to find this next creative faculty position and because of the squeeze that has not happened and he is going to china where he will find themselves surrounded by incredible resources as china continues to increase its support for medical research by 20% year while we have been decreasing our steadily over the

last five years. we can fix this but i think it will take the power of all of you and the recognition that this needs to be not an afterthought but a high priority for our nation because we are at risk of losing something which has been one of america's greatest success stories in biomedical research. thank you. >> i have the privilege of being at the university of michigan medical school, so i have the privilege of serving as dean at the university of michigan medical school and actually being involved in all aspects of training future scientists and physicians to discovery, application in patient care. so seeing that whole ecosystem and what frances mentioned as to

the angst in still by lack of reliable funding levels for nih is absolutely true. however, there are other things that would be very helpful. the regulatory burdens overlaid on our faculty and staff over the last several years our ever-growing. these are unfunded mandates, very basic things like depending upon what institute you are dealing with, what branch of government you are dealing with. there are different conflict of interest regulations. keeping up with that, being compliant is an administrative burden that has no value added and so asking congress to help come up with the uniform approach would be very helpful.

similarly, as we look to move our discoveries into commercialization, we find there are gaps in the ecosystem. basic researchers can discover mechanisms. we can come up with targets, we can develop madisons, we can develop devices but then it requires a large number of other individuals, partners with industry, partners with government in order to move that forward because we don't have all that expertise in the university and unfortunately those partnerships are sometimes difficult to develop because of regulatory burdens on, at a very basic level it would be helpful if in the fda, there would be a checklist. faculty as they move devices forward have found a lot of

cooperation from members of the fda that are really trying to help them do their job but at least at the initial stages, what we had to develop our navigators' because the complexities of interacting with these agencies i such that our faculty have to be educated and potentially there are ways to relieve partner with government in a different way to facilitate that interaction. i think it would be helpful if congress could help move governmental agencies forward so there is uniform conflict of interest, ways that we can access the regulatory bureaus in a systematic way that is more

transparent. >> i am janet woodcock. i want to talk about pharmaceuticals in particular, not in this matter, innovation. if you look at the whole ecosystem i think there are some major barriers, academics and developers alike face when they try to go from a discoveries they make a laboratory to an actual product given to patients. in order to deal with this, the clinical trial system we have is not a system. what is done right now is for every product -- they get a clinical trial, that takes a year to get a clinical trial together and they do the clinical trial that shut the clinical trial down but if it is successful maybe they will try to start another clinical trial landed ten agreements at ten university's, material transfer, it takes years and it is

exhausting to investigators and many lawyers. what we are starting to do, we are starting to look at clinical trial networks, turn the paradigm on its head and a clinical trial network that is funded and when you get inventions that clinical trial network tests the invention, they test it right away and you get multiple drugs or even drug devices, diagnostics all to be tested by this network, much faster, more independent if i may say because the product or whatever it is from an academic or company is given to the network, they evaluate it so there is some distance there between the evaluators and inventor so to speak but it saves a lot of money and to head to head comparison you are testing multiple products as well as approved therapies at the same time so that is

something that could be advanced, to sit at more clinical trial networks, groups that have done that like cystic fibrosis, that is why they succeeded in really getting products for that rare disease on the market because they have the patients ready, they have the jeannette types, investigators are trained, everybody is ready to go. that is one thing. another thing you may not be interested in but i am interested and i will bring in a because it has to do with jobs, drug manufacturing is a lot of innovation in drug manufacturing, have a big meeting in a few weeks about this. so right now we have drug shortages that are affecting hospitals across the country. we by many drugs from other countries and if something would happen we wouldn't be able to get those drugs anymore. jeter hostility, natural disaster, whatever comments and thirdly, that is another thing that is faced by developers. they have to scale up their

manufacturing. it is very much like the chemicals trial system, very outdated, very cumbersome. there is now the technology available to do these continuous manufacturing and make things in the united states, they wouldn't have to be all over the place. it is environmentally friendly and it is the wave of the future the way drugs should be made, where they are needed. that is another area and under a critical path initiative, we don't talk about this anymore but and the knows about it, there is a lot of translation oil research that needs to be done on by 0 markers and many other things that would really aid in getting products from the personal laboratory through and into the clinic and the clinical development and that is another thing that should be worked on, a tremendous opportunity.

>> mr. chairman, i want to thank you for your leadership and the leadership of mr. degette in bringing us together. there are words like ecosystem that francis alluded to risk. it is important to keep in mind that this process of discovery, development and delivery is now a very cyclical one and it lends itself to tremendous opportunities with regard to acceleration of that process if we pay attention to the each use of what does accelerate it, namely the investment of intellectual capital as well as financial capital. and francis has already alluded to some of the risks that are now associated with that investment. there are also the risks that have been raised with regard to the regulatory components of

this and we are seeing even on the other end of the spectrum risks as it relates to the rewards, namely reimbursement and the challenges coming from that so if congress takes a holistic view of this ecosystem and looks at policy changes one of the general themes will be to look at those initiatives that will reduce the risk within this system and that will promote and enable a greater participation and investment in accelerating the cycle. one of those particular things that needs to be addressed is the transfer of data across the cycle. and the opportunity for greater data sharing and greater data integration. there are dated challenges on the front end as we see the transfer of data from investigators to developers and the challenges of data sharing among developers is they now

need to create integrated products like the combination of diagnostics and therapeutics and there are problems on the other end, the need for looking at our clinical trial designs in a way we are dealing with data as it relates to the delivery of these new interventions of you have put in place an enormously important process that will enable us over the next months to step back and take a careful look at all of the components of this ecosystem that needs attention and reduce the risk that is currently growing and flowing down the frost tests. >> thanks for inviting us to be part of this. it is an honor and privilege. i came out of graduate school and were congressional office of technology assessment and this is -- all you describe this as unusual it is certainly the norm

for a long time to come together and talk about these critical issues so in terms of answering the question of what can congress do, you are doing part of the work which is putting a spotlight on research science and innovation as a national treasure, a national priority. if you are prioritizing the research i follow suit with what dr. collins articulated in terms of the resource issue. i don't think you can escape the responsibilities of congress to make sure these agencies are adequately funded. united for medical research is the group that has come together, the alliance for stronger fda is a group i have had the privilege of serving as past president of, a group of all the different stakeholders coming together to say the appropriate dollars that go to the fda are extremely valuable land they are not enough so i

think that prioritizing the infrastructure has to happen. it is a critical necessity and if we are not listening to that bill being wrong, then i do believe as you are doing this in terms of your leadership function we run the risk of really losing an enterprise the united states essentially pioneered. in terms of another priority that i think you're starting to hear a little bit about, we have to put patients of the center so if you look at the statistics we have 7,000 diseases yet we have treatments for i believe dr. collins, 500 of those so the system is doing its work churning through the science, getting out comes to the doors of the fda, the fda is doing its work and then we get some approvals and put that out into the system but at the rate we are going i don't think any of the diseases we are all going to be afflicted with at some point in time stand a chance of being

covered in the near-term so i think the speed issue that is articulated by many of you is of critical importance. as this group does its work, figuring out whether those points to d risk the system as dr. von eschenbach has articulated will be of critical importance for all these stakeholders you have gathered here today and you will going forward to come to some agreement about those pressure points. we have seen in a world of faster cures we had a privileged opportunity to work with a variety of different disease foundations of the cystic fibrosis foundation was noted. mike created the prostate cancer foundation and the melanoma research alliance, a multitude of these groups. what the system can learn and what we have studied is that they are 1-stop shopping in terms of really understanding what science do we know, what don't we know, where do we need

to be getting prepared for, where is the pot going to go and how do you bring the patient into the center of all that's a local points i want to talk about is the sacredness of this innovation ecosystem and the real need for that stability to come and putting the patient at the center of it and i want to make sure as you do your work we are making sure that happens. thank you. >> i want to thank you for convening. can you hear me? want to thank you for convening this important committee and i want to thank congress for their work. recently through the reauthorization of the act, we had -- -- >> some time, we had a mechanism

sponsored by friends of cancer research. was bipartisan, sponsored on the senate side, the house side, had supported industry, patients, companies and a mechanism to get patients drugs faster and better, whether there was evidence or unmet need. this is an extraordinary vehicle and i know to get sponsored on the house side and senator bennett and catch on the other side that is an example of how coming together in a bipartisan way was not just aspirational issues but strong evidence to get drugs to patients that are better for them. there are other opportunities. it is a little bit like that dickens novel. is the best of times and the worst of times, we have

extraordinary biomedical infrastructure, we are doing incredible things. the science has never been better but it is endangered but there are things we can do better, we do have foundations at the nih and the fda that can be empowered and should be and are doing a lot but could be doing more. we are convening now with the fda and the nih a public/private partnership on lung cancer. it will be at 400 sites all over the united states and $25 million into companies, companies are putting $125 million in for a deadly disease, lung cancer where there are no cures. it is next-generation sequencing, it is really a partnership between the fda, companies -- their are novel ways we can get there and there

are things we can do but we cannot take what we have for granted and if we don't get the science we will not benefit. >> thank you for the opportunity to be here today. one of the big inefficiencies we face which is particularly acute and the medical device side is the ability to make optimal use of data that is collected as a part of real-world clinical practice and this is the impact it is having. in the medical device program at the fda we have been looking at how to reduce clinical trial burden on medical device innovators and what they need to bring their profit to market. in appropriate cases shifting the data collection to the post market setting, and we need to reduce the burden on the post market side by being able to better walleye and data collected by doctors in a clinical practice.

two weeks ago we put out two guidances. one of them propose a new pathway for high-risk devices, serious conditions that address and unmet medical needs and we built up experiences from the drug program on accelerator prove land and other features which allows for moving data we otherwise -- data, pre-market into post market but here's the challenge. if you look at how we collect data today, in practice a lot goes in electronic medical records but it is very hard to identify which device was used. jeter it is not in there or it is hard to locate so one of the solutions you directed us to implement is to create a unique device identifier. it is the numbers that says who is the manufacture, what is the diversion of the device? the version of the device is constantly changing and put that on the labelling of the product and the next few months for the first time devices start having

those numbers because we issue a rule last year that here is the next step. it has to get to electronic health records so what are the incentives that can be in place to build the field's electronic health records to capture that information and for doctors and hospitals to then put it into electronic health records? then we can make use of it and use the big data. the other part is sometimes you need more data than what is getting critical practice. but doctors would get it when they're seeing patients and as a device registries and there are challenges for setting them up. exploring those barriers and with the incentives can be in place for creating those registry's because when they are there we are talking about easier data collection and even the case where the manufacturer doesn't need to get the data, we very recently allowed for expansion of the labeling indication on the device where the company and health care professional societies were going to do clinical trial and

we told them don't do it, don't waste your time. we looked at the registry data and we said we think it is good enough. as this to expand labeling, we will do it. you don't need to do it. we have those investments in this country and that kind of infrastructure to allow greater use of data we collect every day. we think that can have a big impact on reducing burden for products to get to market and i think create critical incentives for more innovation in the medical device business. >> i would like to echo the sentiments of the other panelists. thank you for the opportunity. this is a great opportunity. >> told a little bit closer for the folks that are listening at home. >> i represent the -- i am delighted to participate today. i would like to follow up on dr. shuren said. we heard from other panelists that clinical trials can be a

barrier to development, a could be $1 billion in ten years to get products to market and what can congress do? there's an opportunity to look at how technologies can be used to support clinical trials. so we talked about clinical trials networks which would be particularly important for example in the area of antibiotics were there are real problems enrolling patients and window clinical trials are a barrier to product development and on the registered side we have a project looking at medical devices and we spent a lot of time looking at the from less of registry. it is interesting that registries do have the from us of being able to assess product safety and effectiveness, product health care is delivered, lot of interesting

ways you can go. we had registry in the united states doing good work but we are not advanced as other countries so for example there was an article in the new england journal of medicine published last year about a trial in sweden using an existing clinical trial registry, an existing clinical registry, trial of a cardiac intervention. the study enrolled 10,000 patients, 7,000 are randomized. and the total cost was $300,000, $50 a patient for the 700,000 that randomize. you could not do that in the united states. to do try like that in the united states you could probably do is we for patients. cell there are definitely opportunities with clinical registries to actually help with product development and i encourage you to look at that as you are thinking about moving forward. you will hear a lot about the challenges of trials and the answer is not to get rid of

landmark controlled trials. it is the landmark and we needed at the end the they, regulators needed data entered with products and clinicians need the data in order to know if the product is safe and effective and patients needed data to know if it is the right product for them. so the question is how to gather the data more efficiently. thank you. >> thank you and i want to thank this committee for taking on this extremely important issue in this way. i testified in front of this committee three years ago and talked in my capacity as a venture capital investor about the trajectory of the venture investment and innovative life science companies and presented data showing that trajectory was in an alarming state of decline as one indicator of the state of investment and by medical innovation in this country and i attributed that phenomena at the time to a relentless increase in

the time and cost of developing new drugs and medical products, not just over the last few years but over the course of several decades to the point where we now all talk about these statistics and it takes 10 to 15 years and costs $1 billion to develop a drug and we feel that that is an unacceptable place to be. it is now three years later and looking at the same metrics in terms of venture-capital investments in new and innovative biotechnology companies the picture is strikingly different. it is much better. appears much better than it did just a few years ago and over the past year we have seen a resurgence in interest and a resurgence in the dollars being invested in this industry from a venture-capital point of view so to answer the question of what we can do to build on that and further improve part of the answers to think about how is it we have gotten better at least on this one measure over the last three years? i point two factors that have

driven the increase in venture investment in the sector. one is the breakthrough science. the kinds of treatments, the kinds of cures we are now investing in and developing and bringing to patients are transforming of in areas like cancer, genetic diseases and many others, we are seeing an impact on disease that is remarkable and would have been hard to predict only a few years ago. that is a function of decades of investment in basic research and fundamental understanding of biology and the mechanisms of disease over the course of decade so that is number one, break through science. number 2 is a dramatically improved drug development environment and regulatory environment by which i really mean a renewed focus by all parts of this community led by fda but also patient groups, industry, medical community to

work together to address the problem recognizing nobody is happy when it takes 10 to 15 years to develop drugs, patients are waiting too long and is driving investment away from this critical sector so when you look at things to highlight dr. siegel's point that is emblematic of one of lot number of initiatives that has led to a different kind of dialogue about how we develop drugs and regulate drugs and need to think about while always insuring that we get good products that are safe and effective to patients and do so as quickly as possible and efficiently as possible especially for those drugs that make a real dramatic impact on serious diseases recognizing the amount of uncertainty and amount of risk patients are willing to take in accessing those drugs so those two things have in my mind driven the resurgence of venture-capital in biotech so i would say from a big picture

perspective focus on those two sing is reiterating the call to make sure we have consistent funding for biomedical research for nih and fda. he says the investments in the public sector the drive the opportunities to create these breakthrough cures and second, let's continue what we started over the last several years which is a real mature dialogue about the regulatory process, drug development and benefit and risk and how we can responsibly accelerate bringing fair piece to patients. >> i represent the oregon health science university, i too appreciate the attention you are giving to this critically important area. i come to this discussion with background -- >> please bring the mike down. >> i come to this discussion with a background in physics and

engineering and somebody who has tried to pay attention to the technology we are bringing to bear to understand how it is we can best explore this cycle, i would encourage us to think about this as a four step cycle that tweaks that did this three step cycle. one of the things that is limiting our ability to move drugs effectively into the clinic is the fact the we don't take advantage, take as much advantage of the clinical trials we are conducting as we might. the technologies we have today provide us an enormous amount of information about the behavior of the biological systems we are trying to manipulate therapeutically. the reason these drugs treatment strategies are so expensive to develop is most of them don't work as we expect them to work. what that means is the model systems are not as informative

as we might like and to be. today with the technologies we have in hand, we have the opportunity to learn in great detail why it is the strategies we are failing on to do so. and to use that information to go back and improve the model systems we are using to develop these treatments. that requires >> reporter: clinical trials we learn as much as we can possibly learn from every patient, that means we have to get the samples to analyze them. that means we have to have broadly distributed the analytical technologies that we need to to understand, we need to bring back individuals, and to understand why it was that are models didn't teach us as much as we needed to know.

and one of them in today's community, the basic science community, researchers are dragged farther and farther for the translation oil side of the house. and away from unfettered basic science discovery. one of the things our technologies are teaching us is the complexity of the biological systems that we are trying to manipulate. they are much more complicated than we thought a decade ago but we have technologies to understand the molecular machines of life. this requires we invest in some basic science to understand how these molecular machines work so i would call first clinical trials designed to be as informative as we can get them and investment into basic research, substantial investment in basic research to understand what we don't know about our

system this and finally this is going to require we continue to invest in analytical technologies for this country. and advanced computer system to securely manage the unprecedented amounts of data, and something to be managed securely. and one of the problems we have in this country today is we are falling behind in our technical infrastructure. it is difficult to acquire the instruments, difficult replaced when they go obsolete and this was something that happens pretty much in 18 months to two year cycle these days and we can't even sustain some with service contracts so we are going to have to keep the infrastructure in this country technical infrastructure up or we will cease to become competitive.

we are losing scientists to other countries who are doing a better job in making the instruments of science available. >> mr. chairman of the white paper you circulated with your invitation for which i am as grateful as everybody else. and a perceived golf, i have read extensively and i think the view is widely shared, there is the -- cancer is one of the most generously treated areas by the fda. there is a 2010 report from the bile marker consensus collectivizing was the title, which i believe included representatives from the fda and the private industry and simply saying making this exact same point. in some considerable detail in no uncertain language that somehow or other the basic research was moving far ahead of

our ability to transform it into working drugs. i think you can break -- i am so sorry. >> just speak a little closer -- >> i think -- you can break down the essence of this fantastic revolution we are witnessing in to four rough categories, for the first time in medical history we are able to see absolutely everything down to the molecular bottom. nothing comparable even remotely to this revolution since the advent of germ theory 150 years ago, that transformed medicine. that makes a big difference, that lead quickly to vaccines and antibiotics. the cost of doing that has dropped. the gm sequencing curves are well known. we can see the proteins, we are really good at seeing what is there and this is useful because drugs do their thing at the molecular level.

that is where the action begins. doesn't end there's been a few can see at all that puts you in a different world from the one that has been known through most of medical history. we are getting extremely good, and to say one on one if i can get this to the target can you modulate it or destroyed or do something? they are very good at that these days. we have structure based drug design which we won a nobel prize for. and hitting this in 1988, and monochrome antibodies which are targeted drugs and we're doing remarkable things now. we have stem cells drawn from the patient and genetically engineered and returned to the patient, a sibling group of therapies using white blood cells extracted from the patient and engineered to attack cancer so some stunning results coming.

this is the newest area and look at how the people involved are engineering fees cells and is as logical as writing a fossil. they're taking a gene or turning one offense to get in, dispatching a to do something. and this nimble genius of this is stunning, and in the other two areas, we still lead the world, and we will see if we are getting a lot of other countries that are willing to break every regulatory rule and move forward. we will find out of that ends up in disaster or triumph. this new technology and the ability to see everything poses as presented with scientific and policy question. the scientific part was alluded to by dr. gray, things are messier and more complex than we may have hoped or that they looked when it was just one bacteria and we could go after it and kill it with tetracycline

or something and mission accomplished. these complex webs, there are large variations in the structure of molecules that propelled diseases, the networks are complicated, redundant and we are increasingly seeing the molecular etiology of selecting diseases. we confronted this first with the advent of hiv in the 80s and through the 1990s, they are complex and slow. this means using traditional fda trials, the process is slow and complex. we often don't get the right results from trials unless we are thinking in these terms for. the economics of drug development has been cited a large fraction of economics is centered on the clinical trial process. time value of money is very large so you have the clock ticking on up-front investments and the trials themselves are expensive to conduct and the clock is ticking on a patents. you have some extension after that. that is the scientific

challenge. you can see all this stuff down there and you cannot delete something that you tried to work out what to modulate and i have to say since the passage -- i may be dreaming but i think nih has launched a series of projects beginning in 2013. they go back earlier than that. they had the thousand genomes project and since then a lot of interesting studies going back to clinical trials of the past that have failed and work out why they failed and their plucking out the exceptional responders and this is terrific stuff and we should be -- the regret is we were not doing all along. i am not sure why we weren't but any way they are the apps program that is a paradigm of what we should be doing to get this science right. now we move into the drug or the bile marker target selection, and those are extremely important because they feed directly or ought to feed directly into the fda approval

process. the accelerated approval, we all know about what we ought to, invented in the late 1980s, added to the federal regulations in the 1990s, lets you regulate not conditionally, or accelerated approval on the basis of surrogate or intermediate end points and that hinges on biosmarkers of one kind or another, the nih is doing what ought to be done. i don't know if this is the reaction or not but they're doing exactly right. the most important thing we can do to seriously accelerate drug approval and lower the cost is to get the fda at the table for a number of these initiatives. don't know if it is every one of them but the fda is at a table giving input. others can tell me how details it is.

we should have one process that makes these calls, not do them multiple times in different agencies. we want to bring in the other stakeholders. if we could get that process moving we would substantially accelerate the approval of drugs, lower the cost and face less challenge and competition from other countries that are willing to do this less well-financed but are willing to cut lot of corners. >> thank you all. let me just say i will let my colleague have some questions here. i almost feel you were bound to ask the questions we have asked. you are excited, enthusiastic, and it is about time someone actually allow you to answer some of the questions, and even though we asked just one, it seems many of you have covered all four so i am not going to take the next three hours to do

the next three questions but instead i know a number of my colleagues, would like to ask some questions and we will do a summary at the end and finished between 5:00 and 5:30 or even before. we will see where it takes us. henry, we are going to be very informal. everyone will have limited time but if we could limit ourselves to a question or two and then let you all respond, maybe not each and every one of you but help us. >> thank you for your presentations today. it just seems the basic is the research, investment in basic research that is needed for the whole process to work and if you ask anybody in the public what they think the best investment of government funds is, it is the national institutes of health yet we have heard the term we need more stable and predictable levels of funding.

i am concerned we have spending caps in place for non-defense discretionary, by as much as 15% in 2016 under the ryan budget which was adopted by the house, that would jeopardize critical federal funding as a result undermining the discovery process. we have also had sequestration which was supposed to never happen but did happen. nih was severely affected by that so i am interested in the reliable, adequate funding levels. that is my question to you and there seems to be an underlying assumption that all the time it takes to get drugs approved is the problem at the fda and i want to know if that is accurate? can you give us a more

transparent understanding of why it takes a long time and should we lower the standards for approval of drugs without knowing whether they are working or not? if you would both respond? >> thank you for the question. there are various ways of assessing the state of health, biomedical research, one can look at the trajectory over the last 40 or 50 years and you can see in fact for most of that time, nih support was following a stable trajectory of inflation plus 4%, that was true from 1970 until 1998. 1998 there was a wonderful development of a doubling fur nih which many view at a ruling and was beneficial for ramping up the ability to do things faster and in a more risk-taking way which was bipartisan.

>> waxman upton bill. >> the speaker was upton waxman. >> the expectation of everybody was that was going to set a new base but in fact what happened was that the end of that doubling, essentials the nih's budget flat off and remained so with inflation gradually easing away at the purchasing power. the sequester added immeasurably to the pain of that experience, cutting one billion dollars half way through fiscal year 13 which has not been fully recovered in f y 14. we are below where we were in 12. ..

we have a budget that calls for severe decreases. do you think that makes sense? does anybody here thinks that make sense for a system where we are trying to find cures? >> why is medical research discretionary? what is the health of our nation discretionary? if something odd about the way in which is is all divided up from the budget table. from my perspective this is one of the most important investments a country can make. every other country in the world seems to think that to be the case. we seem to have lost our way. >> i think that's an important point, and the way the house is

already operated, is to put in place cuts that are going to take effect later. dr. woodcock, it takes so long to get these drugs approved. is at all fda's fault? >> there are some standards that are enforced in most parts of the development. after a drug is discovered, companies that figure whether it's worth investing in. so they do studies to see whether they think it's going to work before they put into people. that's a good business decision. that's not driven by the fda. there's also toxicology studies that have to be done in animals to make sure it's safe enough to be put in the first human volunteers. there's a few people who would so you shouldn't do that actually. if you're going to be one of those volunteers. we have a very good record of many thousands of commercial i in peace, very. you get into people, there are side effects but they can be managed. the clinical phase is the most expensive and that's where the most arguments are about.

it costs a lot per patient in the united states to do this, and those studies are done to meet the fda standards to show that statutorily embodied to show that the drug is safe enough and that it has effectiveness and it works. at the end of the day the benefit risk analysis so that a terrible disease, you know, you don't have to be as safe basically and so forth. and then the fda review time is really just a little blip on the end. if we approve drugs as fast as sometimes 45 days or perhaps three months, ordinary drug, specifies time frames that are under a year for the fda review of all that information. >> thanks. >> i'd like to address the issue of fda, is it too fast or too slow. the answer is it's just about

right. about three years ago i went to africa, the largest cancer meetings in the world, and companies were telling us everything is faster in europe. this is for cancer and we were really worried. and we embarked on a study because, in fact, drugs, patients are having access to drugs in europe faster than the united states. this was an issue. our research showed the opposite. it shows the opposite that everybody said they would never believe it unless you would publish it. and, in fact, we were faster. we were substantially faster. what is important is that we have to be better. what really is important is that these treatment have to work for patients. so getting out faster, a drug that doesn't work that is toxic, has no benefit, is no benefit for patient or a company. yes, we have a lot of issues a lot of issues with a clinical trial system, a lot of issues about how we design trials that at the end of the day what a

patient wants is a treatment that works for them. >> i want to thank -- i don't know what to call you guys, panel, advisors, participants, whatever, patriots -- for your opening remarks. i don't think it's a surprise that dr. collins wants a more stable and increased funding system. it would be news if you didn't. i don't think it's a surprise that the ranking democrat on the committee agrees with him. i mean, that's not a newsflash. >> everybody else. >> and everybody else. having said that, there are financial constraints we have to operate under. i was gratified to a lot of comments by the folks that have been speaking about regulatory reform, unfunded mandates.

dr. woodcock mentioned something called a clinical trial network, which i think has merit. dr. von eschenbach talk about reducing risk within the system. dr. shuren asked about improving or directing that we improve electronic health records. ms. despres talked about something called a clinical registry. dr. gray was talking about greater investment in what he called analytical technology. and dr. huber talked about process reform. so we have lots of ideas. one thing that was mentioned, mr. chairman, that i'd like dr. woodcock to comment on, i have a number of small medical device manufacturers in my district who were coming out and getting approved by the fda, new

devices and medical applications where they do interactive with their electronic devices come with their doctor, in therapy and also in diagnosis. fda approves them, but the cms, ma medicare won't give them a coat or doesn't know where to fit within the current system. how do we handle something like that where it's a technology or debate that's been approved. they know it will help people, then we get bogged down in bureaucracy of trying to code it and how to reimburse it through medicare. >> you may wish to ask dr. shuren that actually. he said of the device center. >> he's the man, i'm willing to listen. so, dr. woodcock frozen under the bus so i can throw -- what a great country we have the.

i'll apologize by dancing a little bit around it because india by colleagues at the cms, but you're raising an important point, which is a funny developer of a technology what i need is predictability, not just to get to market but to get reimbursed. and as a public health official and physician what i care about is also patient access. we know patients don't have real access in many cases unless there's also reimbursement for the technology, particularly if we do with more expensive technologies are part of an expensive procedure. many are disenfranchised because they won't have them money and coverage for. when you think about are there circumstances we can provide a more streamlined pathway and more guarantees if you're getting actually through the fda, are there circumstances where you should get paid for. or there's a tie in to where you're paid for and there's that additional data collection. cms will sometimes do that. there's something called coverage with evidence

development where they say we'll take it as it comes but there's additional information but at least you were getting reimbursed for it. i think that is a critical area to be looking at, how we can provide that greater predictability. >> thank you, mr. chairman. >> thank you. let me thank chairman upton and congressmen to get for putting this together. i think it's a freshman congressman to, if of those participating. i just want to sort of as the general question, dr. collins or mr. gray, or anyone really could answer it. you know, i constantly hear, within the white paper, dr. collins mentioned, and mr. waxman mentioned, about funding. in other words, obviously there's not as much money available to nih as they used to be.

you mentioned a researcher who went to china because he thought there were better opportunities there. mr. gray mentioned the technical infrastructure, you know, that we are falling behind or i'm just ready to handle. we are constantly told that we are falling behind, the sense that we're not keeping up. is it because of lack of federal funds? is it because we're not investing in labs or technical infrastructure? when you use china it's hard for me to figure out what that really means is of course china is a communist state run, here we have money for research or research being done by private companies, states kicking in, universities taking in. is the advantage that china has strictly that their national government or the government is spending more money, or does it go beyond that? doesn't have to do with the fact that they organize all this in a very dictatorial fashion? i'm just trying to get -- when

we say what we can do, we could spend more money but is it just a question of federal dollars, or does it go beyond that in the sense that it deals with the infrastructure, or is it the way they get together to do the research in a way that we don't? >> so, it's -- >> i know it's kind of a general question but i hear this all the time, it's so difficult to see the comparison with china because it's such a different type of political structure. >> and china is not the only example. to answer your question about why they're able to do this so quickly, clearly they have a decision process that is much more top down, and they basically can make such a decision and implement it quickly, and they've been increasing their support of medical research by about 22% per year now for several years. within the next few years they will actually outstrip the united states in absolute dollar spent on medical research. that is their goal. they been very clear about that

and they have a system that basically allows that to happen once that decision is made. it's not just china that is read our playbook. singapore, south korea, brazil. my goodness, look at europe which is not have been easy time economic time either. germany or the united kingdom recognizing medical research is a strong component of the success of the economy. they protected that and it continued to increase support even at a time were other things are being cut back. they've looked at america's authority -- story and they're trying to learn from the. my greatest concern is not about the way in which this is affecting anything in the way of nuts and bolts of bricks and mortar. it's the most important resource we have, which are the scientist, a biomedical research community, particularly the next generation. they are under serious threat. is spending 60, 70% of the time just writing grants because their success rate has dropped to one out of six. most of the time it's another failure. they're getting discouraged.

they are increasingly taking less risks because risky sites doesn't seem like it's got much of a chance. with coming up with all sorts ways to stimulate their innovative instincts not they are flagging a bit in that regard but if we really want to see our future we have found that resource supported. that's wake me up at night but we are leaving about half of the great science on the table that this next generation of scientists wants to be untraditional would have been supported in the past and now is not. >> mr. pallone, you really have placed the question right dead center. and to my way of thinking it's not about just investment or funding. it's about creating opportunity, and that's a much larger set of issues it has a lot to do with some of the other things that go beyond funding, like changing the infrastructure, for example. but at the core of it is the point that mr. leff made, is that everyone around the world recognizes this explosion in

science and technology is changing not just medicine, but all the rest of the life sciences. and, in fact, it's not just about nih or just about biomedical research. as dr. gray pointed out, we are seeing a convergence now of the physical sciences along with the biological sciences, and the emergence of material sciences, nanotechnology, for example, competition signs, is as equally important for this country. so we should be paying attention even to the agencies and the government beyond the nih such as the department of energy and our national laboratory which are an enormously important part of this future frontier. and i think what the committee has labor force is a challenge to get beyond just the question of are we funding, but more importantly, are we creating the

opportunities and changing the ecosystem in a way that really will keep us at the forefront. >> to rid the build on that, the creativity happens in large part in universities where a job of somebody like me is to facilitate serendipity. because oftentimes the innovations now are at the boundaries between traditional disciplines. so one of the things we're doing at michigan is how do we consciously bring engineering and the life sciences together? we have changed the biomedical engineering department from being solely in the college of engineering now to being joined in the medical school and the college of engineering. because it's that human human interaction where the creativity occurs. there are critical facilities,

finances, technology, much of the breakthroughs in medicine in our understanding our technology dependent. and so what we are trying to figure out is how do we give real problems to the engineers so that they can help us make advances in understanding, not just of disease, but also of health, which actually is the ultimate goal for where we are. so it's looking at that total ecosystem, not just one piece, that's really critical to maintain our creative advantage and th believed that we've had r arguably over the last century. >> just to continue this dialogue. i want to come back to one of the consequences of the klein in real spending dollars that's

happened over the last few years, and one of the things that's happened is the sciences have become hypercompetitive. dr. collins mentioned it, i think people are spending a large amount of their time writing grants. they are after spending a large amount of the time writing nonproductive grants. these are grants that will not get funded. so you basically taken the thinking time away from your scientific community that would be used to innovate and are forcing the community to just pushing paper around. that is really a killer. one of the reasons that we are calling for stable funding, maybe it doesn't have to be increased, vastly increased funding, but strategies to deploy funding that ensures that our best scientists, our most productive scientists are spending their time thinking about science and not spend the time writing grants. so if we could aspire to have long-term funding goals in this country, perhaps with achievable

granular objectives, then i think that people would feel confident in saying okay, i can take risks, i can try some new things, i won't be out of a job because, you know, somehow i took on a risk in failed. so we have to enable ourselves to break out of this hypercompetitive cycle if you back to thinking about science. we can do this by defining where we are going, what money is going to take to get there and identifying the scientist that we need to get us there. >> so just to echo the point about it's not just being china, i also want to punctuate this idea that even the european community has really banded together because they see this as such an amazing growth opportunity. the fastercures did a study, consortia of phenomena, an element of what we're talking about here, how do different entities come together to solve problems. there are lots of consortia that

happen in the trendy. some are administered by the foundation for the nih, some by the fda or the have participation, but there are a whole heckuva lot of them in europe right now. the numbers are going up, up, up. i look at it as a little less of is the u.s. declining and a little bit more of is everybody else catching up? so perhaps it can be thinking about it in terms of what is it that we can use to keep that competitive edge, keep the secret sauce of the american ingenuity, the innovation, you know, what took place at the beginning of the biotech revolution. there are unique attributes i think in terms of how the american scientific enterprise operates, that we don't want to lose for a whole lot of reasons. because of what it has produced thus far and what we expect it to produce. so i think that the u.s. is still looked at as the place for everyone to kind of model after. they are modeling after the gold

standard of the food and drug administration. they are modeling after the nih and the other science agencies that dr. von eschenbach articulated, but i think the question and the challenge in front of you all is what's that all going to look like in 10 years, 15 years? we are talking about bringing in different disciplines, bringing in a collaborative spirit, team sites. i have an 11 year old daughter who is on a team tomorrow to assimilate the westward expansion, hiking five miles with our little red and again through the fields in virginia. she at 11 understand teamwork in an entirely different way than i think any of us were schooled in. and i think if you want to entice kids like that to go into science careers, to have to be the sense of there's something for them to step into. and i think if we lose that opportunity, all of this were going on, whether china, europe, lots of other places, it's just going to keep going because all those countries have prioritized

this and said this is something that we need to be paying attention to. >> before i let surrogate the last word and they will go to dr. burgess, dean kamen is going to be one person we're going to rely on. of course, that's his focus in life. sera? >> so think of this as an ecosystem from our standpoint, absolutely the right way to look at it, and you talked about kind of a continuum of discovery development and delivery, and it raises the question of how you're going to make sure it's actually a feedback. so we've been hearing about the need to invest in research and that's critical but there's also the need to ensure that we have the tools to collect the data and disseminate the data. so i spoke about a trial in sweden, very efficient, a lot more expensive. they are able to do that and much part because they have the interoperable electronic health

records. as you think about the kinds of what needs attention in the united states that we can be competitive in terms of innovation. i urge you to keep in mind they need to make sure that we have the data system that will allow for researchers to bring the products to market more quickly and then also to understand how these products are being used in the real world. because it's one thing to see them in a clinical trial but then in the real world it's a different game. and what happens in the real world experience can inform the next generation of products. so the data collection is a critical component of this as well. >> thank you, mr. chairman. thank you for convening this group. i think it's extremely important that we have this discussion. i have an observation and then i have a question to some on the panel. the observation would be, the

last thing we did in calendar year 2006 was reauthorize the national institute of health. we are authorized at a base level of $31 billion, to increase by 5% every year. we were eviscerated at the time because of that number was woefully small, and then no subsequent session of congress, republican, democrat or a by the government came anywhere close to 5%. it has been as dr. collins put out much less than that. so perhaps we should consider a reauthorization that has been now some years ago. perhaps we should consider reauthorizing an age. dr. collins, i would just point out to you that all the buildings on to find campus, been there many times, that there all day and after appropriators. the authorizers who are your friends here, not the appropriators. the question i want to shift gears for a little bit and i will have to go to another hearing, but you hear a lot these days about the right to try for people who have serious and terminal illnesses who may

have, find there's a builder of a clinical trial that they can get on. can any of you address that? i think goldwater institute is doing some work on this and it's one of those things that certainly pulls on the heartstrings and constituents tackle. can we talk about that a little bit? >> i can, as far as for pharmaceuticals. generally speaking, we have a very liberal policy about people getting on to what people called compassionate use, but basically treatment protocols, if they can't get into a trial for an investigational drug. i think i testified a while ago, we had one pass requests and we only turned down to in a year. we get about that number of requests each year. however, companies for a variety of reasons are sometimes not willing to provide drugs under investigational that are investigational drugs to patients under treatment

protocols. they have a variety of reasons, shortage. they often say they are concerned that side effects will be found out in these patients that actually wasn't in the clinical trial and it will delay their development program. it's never happened, but that's often cited as a fear. then there's a financial cost to providing the drug, although you can do cost recovery. you can't sell the drug at a profit in a treatment trial. and so there are many people who have been unable to obtain drugs under treatment protocols from a company. that does happen. >> isn't anything that we can do? this is a roundtable about solutions. is there anything we can do as far as providing companies the certainty they would need or the liability protection that they might need? are the places we can do with that? >> i think you could ask the company. i think from the fda standpoint we would be very reluctant to

have you passed something says we can't look at their treatment experience because that would be unfair to the other patients. >> so this issue of extended axis is something we're looking at, working with brookings with cancer research and brookings and working on it. there's some of the very interesting proposals on how we made approach that problem and actually not only get access to the patient but really get data that's important what's missing, often when we get compassionate usage we have no data on exactly what happened. so there is a very unique, a very interesting proposal by trannineteen we're looking at it in our meeting in november, and it will be interesting to see if there's going to be a legislative need to do something on it but it is a very legitimate issue. but at the end of the day we really need to get data. we want to know what happened if

the patient could have access to it. didn't work, did not work? why? so capturing data will be entirely important but i think something people are thinking about. >> trying to alternate between republicans and democrats, let me go to kathy and then joe and leonard. >> let me thank chairman upton for leading this effort today, and thank everyone here on this panel, and thank you for devoting your professional careers to improving the lives of american families. i do think it's an exciting time for biomedical research in the u.s. and across the globe. i have two questions, two points, mainly for dr. collins, but for anybody else who wants to comment. many of you have already stated how much you value our scientists and researchers, and it's just fantastic to me, a lot of these young talented

researchers, for example, at home at the moffitt cancer center in tampa at the university of south florida, all the research universities across the country. and they are not shy in talking to policymakers about the fear they have for the future, that they have, they are passionate. they believe in what they're doing. they are making progress. they see all the technological advancements, but they are very fearful that, based on inconsistencies and uncertainty in funding levels, that this isn't the career for them. and i hate to hear that from them. so i think that congress right now has a very important responsibility to make a newfound commitment to the nih and to research, biomedical research in america. the budget this year, i offered an amendment in the budget committee to move nih funding from discretionary and mandatory. i think this is something that

we should discuss. maybe we do it with dr. graves suggestion that there are certain benchmarks that have to be met or certain requirements. so if you could discuss that or there are other budgetary solutions, and number two, we don't have all of the resources in the world to spend. are you confident that the monies are going to the right place in biomedical research? for example, when you look at much of the data, the aging population, it would seem like we've got to do a whole lot more in brain research, and alzheimer's. but when you look at the threats to the health of america, boy, that is staring us right in the face. so number one, shifting to mandatory funding, and number two, are we making investments in the right place? >> i appreciate the question. in fact, i appreciate this whole panel discussion.

again, i'm not a budget guy so not going to be a clever respondent to this notion of shifting the dollars from one place to the other, but what matters is to find a path forward that has this kind of predictable stability. and again we've lost ground. we need to sort of catch up, but then to have a sense that we will not be on a roller coaster ride, feast or femur. the most destructive thing you can do for the research enterprise. ..