76% oppose cutting social security. the republican approach is just the opposite. they want to cut comairks, they want to cut medicaid, they want it cut social security and they certainly do not want to ask the wealthiest people in this country to pay a nickel more in taxes. well, that's one poll. let's look at another poll. in fact, poll after poll has more or less mir i mir ired. 81% of the american people believe it is totally acceptable or mostly acceptable -- that's how they frame these polls -- to impose a surtax on millionaires to reduce the deficit. let me repeat that. 81% of the american people in "the wall street journal"/nbc

poll think it is totally acceptable or mostly acceptable to impose a surtax on millionaires to reduce the deficit. 81% of the american people think it is a good idea and yet we can't get one republican to ask the wealthy to pay a nickel more in taxes. talk about being out of touch with what the american people want. 74% in that same poll of the american people believe it is totally acceptable or mostly acceptable to eliminate tax credits for the oil and gas industry. and on and on it goes. 7676% believe it is unacceptable or mostly unacceptable to cut medicare to significantly deduce the deficit. now, here's an interesting poll that maybe some of my republican friends want to pay attention to, and that is what while the leaders of the tea party here in washington are fighting to

dismantle medicare and medicaid, it turns out that in another poll done by mcclatchy, 70% -- 7-0 percent -- of those people who side of themselves with the tea party opposed cutting medicare and medicaid to reduce the deficit. that is the tea party. mr. president, here's the last poll i want to highlight -- there are many more out there. it was done by "the washington post" and abc news. here's what that poll says. it says 72% of americans support raising taxes on incomes over $250,000 to dries the national debt, including 91% of the democrats, 68% of independents and 54% of republicans. so here you have in congress, surrounded by lobbyists and powerful special interests, a congress heavily dominated by large campaign contributors, ems

of the senate moving in exactly the opposite direction of where the american people want to go. the american people want shared sacrifice. the american people believe that when the wealthiest people in this country are doing phenomenally well and the gap between the rich and everybody else is growing wider, yes, the wealthiest people have got to contribute to deficit reduction. the american people believe that when you have corporations making record-breaking profits and not paying a nickel in taxes, yes, they have got to start paying taxes. and the american people overwhelmingly believe that it is bad for this country to go after medicare and medicaid and programs that working families desperately depend upon. mr. president, instead of listening to millionaires and billionaires, it is time for our leaders here in washington to start listening to the overwhelming majority of the american people who do want the

wealthiest people in this country and the most profitable corporations to contribute to deficit reduction. it is time for shared sacrifice. the middle class, the elderly, the sick and the poor have already sacrificed enough. it is fipple for those people on top, the people doing extremely well, to also understand that they are americans, they are part of our country, and they have got to contribute to deficit reduction. and the fact of the matter is, mr. president, that moving towards deficit reduction in a way that is fair is not as complicated as some would have us believe. in fact, if you are not beholden to wall street, large corporations and wealthy campaign contributors and you are not frightened about the number of 30-second ads that may be thrown at you if you take these guys on, it is really quite easy. i know that there are many

people out there of good faith who have different ideas about how we can move forward toward a balanced budget, toward deficit reduction. and i am not saying that i have all of the answers. but let me just give you a few examples, a few examples as to how we can reduce the deficit by more than $4 trillion over the next decade, and that includes of course asking the wealthy and large corporations to begin paying their fair share of taxes, andes does not do undue harm to ordinary americans. we can do it. we can do it, if you're concerned about deficit reduction, i am concerned about deficit reduction, but we can do it calling for shared sacrifice and in a way that does not attack programs that millions of millions of children, elderly, and working families are terribly dependent upon. let me just give you aify ideas and other people i know have other good ideas.

first, we simply repeal the bush tax breaks for the top 2%, mr. president. we can raise at least $700 billion over the next decade. that's it. the rich are getting richer. bush gave them huge tax breaks. you repeal that $7500 billion. i know some of me republican grendzs think, oh, my goodness, if you don't give tax breaks to the very wealthy, it will have a negative impact on jobs and this is the trickle-down economic theory. you give tax breaks to the rich, large court of appeals will create all kinds of jobs. well, that idea has been tested. that idea was tested. that was the idea of former president george w. bush, but during his eight years as president, when that idea was in effect, the private sector lost -- lost -- over 600,000 jobs, and we had one of the worst economic decades in terms of job

creation ever seen in this country. we tried that theory. we did give tax breaks to the rich and large corporations and we lost 600,000 jobs during that ten-year period. meanwhile, when bill clinton raised taxes on the top 2%, you know what? the world didn't quite cave in. in fact during clinton's president circumstance we created over 22 million jobs and he left office with a huge budget surplus. but that's just one idea. mr. president, you heard polls say we should impose a surtax on millionaires. a vast majority of the american people believe that. if you did a 5.4 surtax, that would raise $380 billion over ten years. you want another idea? at a fipple when with our manufacturing sector is collapsing, when 50,000 factories have shut down in the last ten years, when millions of workers have lost good-paying

jobs, the united states government continues to reward companies that move u.s. manufacturing jobs overseas through loopholes in the tsm code known as the thorough and foreign source income. that clearly from a financial point of view in terms of revenue to our government as well as policy which results in the loss of millions of goods manufacturing jobs is not something we should sustain. if we ended that absurdity, that policy alone, the joint tax committee has estimated that we could raise more than $582 billion in revenue over the next ten years. so, what about that? $582 billion in revenue and we stop the outsourcing of jobs so that maybe we can rebuild our manufacturing sector. sounds to me like a pretty sensible idea. my republican friends think it is a better idea to throw poor people off of medicaid or force

elderly people to pay far more than they can afford for medicare. but ending this absurd policy, which encourages companies to throw american workers out on the street, makes a lot more sense to me than what the republicans are talking about. fourth, mr. president, if we end the tax breaks and subsidies to the big oil and gas companies, we could reduce the deficit by more than $40 billion over the next ten years. fifth, if we prohibited abusive and illegal offshore tax shelters -- i just talked about a moment ago -- we could bring in $1 trillion over ten years. that says to the corporations and the wealthy, sorry, you're no longer going to be able to stab your wealth in the cayman islands and avoid paying taxes. sixth, mr. president, if we established a wall street speculation fee of less than 1% on the sale and purchase of credit default swaps, stock options and futures, we could

reduce the deficit by more unanimous $100 billion over the next decade and also, also, tell wall street that we're not going to tolerate their outrageous behavior, which led us into this recession in the first place. we are going to dry to get a handle on their speculation. number seven, mr. president, if we tax capital gains and dividends the same way that we tax work, ordinary workers, we can raise more than $730 billion over the next decade. why should somebody who clips dividend coupons pay a substantially lower tax rate than somebody who is out working on our streets or is a nurse or is a teacher? warren buffet has often said that he pays a lower effective tax rate than his secretary. and today the effective tax rates of the wealthiest 400 americans is just 18%, the lowest on record.

and on and on, mr. president. we have a number of ideas out there, not least of which taking a hard look at the military. there are debates as to how much we can cut, but certainly we should all be in agreement that it no longer makes sense to sustain weapons systems that were built in order to fight the cold war against the soviet union. they are not our enemy right now. i can tell you that i, and my office requested a g.a.o. report that found that the pentagon had $36.9 billion in spare parts that it does not need and which are collecting dust in government warehouses. we can do better than that. and frankly, mr. president, in my view -- and i think i speak for the majority of the people in my state of vermont and i suspect in this country -- it is time to begin bringing the troops home from iraq and afghanistan at an accelerated rate. we have been in afghanistan now

for ten years. it is time for the afghan people and their military to take responsibility in terms of defeating the taliban. we should be supportive of those efforts, but we should bring our troops home a lot sooner than the president has suggested, and when we do that among other things, we also are going to save a substantial sum of money. further, mr. president, i will not deny for one second that there is waste and fraud and bureaucracy in almost every government program out there. i think we got to take a hard look at them all. and i believe that in addition to the pentagon, we can save hundreds of billions of dollars a year by eliminating unnecessary bureaucracy. mr. president, the ideas that i've enumerated and some that i have not, but which will become part of the record, if we did all or some of these things, we could easily reduce the deficit by well over $4 trillion over

the next decade. if not in fact much more. it would be done in a way that is fair and it would not unnecessarily and needlessly ruin the lives of some cht most desperate and fragile and hurting people in our country today. millions of people are just struggling to make ends meet. those people would be spared. mr. president, the extreme right-wing agenda of more tax breaks for the wealthy paid for by the dismantling of medicare, medicaid, education, nutrition, and the environment may be popular in the countryclubs and cocktail parties of the wealthy and powerful, but it is way out of touch with what the overwhelming majority of americans want. mr. president, as you know, late last week congressman can terks the republican majority leader in the house, and senator jon

kyl, the republican minority whip in the house, walked out of budget negotiations being led by vice president biden. ant the reason they walked out was pretty clear. they were not willing to close one single loophole in the tax code that allows the wealth ch and large corntions t corporatid paying taxes by stashing their money in the cayman island. mr. president, my sincere hope is that president obama will use this republican walkout -- their unwillingness to talk about the wealthy and large corporations contributing anything toward deficit reduction -- that he will use this as an opportunity to rally the american people and make it clear that he will never support republican demands to move toward a balanced budget solely on the backs of working families, the elderly, the children, the sick, and the poor.

but i don't think that the president will do this, unless the american people send him a message that enough is enough. the american people do not support the republican agenda. the american people support the concept of shared sacrifice, as we move forward deficit reduction. but the president has got hear from the american people. he has got to hear that they will not accept decimating medicare and medicaid, pell grants, education and the environment in order to give more tax breaks to the wealthy. the president has got to stand up for the millions of americans who have seen their homes, their jobs and their savings vanish instead of the millionaires who have never had it so good. mr. president, it is my belief that if the american people make that demand of the president and

tell the president not to yield on this issue, we can win this budget struggle. if people would like to -- and i hope they would -- we have a letter to the president which i'm going to read in a moment on my web site. and also as i mentioned earlier, they can contact the white house directly by going straight to the white house web site and sending a message. and if hundreds of thousands of people do that, the president, i hope, will have the strength and the determination to say to the republicans, sorry, we are not going to balance the budget on the weak and the vulnerable. this is the letter that is on my web site, sanders.senate.gov, which i hope people will sign. and this is what the letter says which i think encapsulates much of what i've been saying for the last hour. this is what it says. it says, "dear mr. president,

this is a pivotal moment in the history of our country. decisions are being made about the national budget that will impact the lives of virtually every american for decades to come. as we address the issue of deficit reduction, we must not ignore the painful economic reality of today, which is that the wealthiest people in our country and the largest corporations are doing phenomenally well while the middle class is collapsing and poverty is increasing. be in fact, the united states today has by far the most unequal distribution of wealth and income of any major country on earth. everyone understands in the long term we have got to reduce the deficit arcs deficit caused mainly by wall street greed, two wars and a prescription drug program written by the drug and insurance companies. it is absolutely imperative, however, that as we go forward with deficit reduction, we completely reject the republican

approach that demands savage cuts in desperately needed programs for working families, the elderly, the sick, our children and the poor, while not asking the wealthiest among us to contribute one penny." and the letter continues, "mr. president, please listen to the overwhelming majority of the american people who believe that deficit reduction must be about shared sacrifice. the wealthiest americans are the most profitable corporations in this country, must pay their fair share. at least 50% --" let me repeat that. "at least 50% of any deficit-reduction package must come from revenue raised by ending tax breaks for the wealthy and eliminating tax loopholes that benefit large, profitable corporations and wall street financial institutions. a sensible deficit-reduction package must also include significant cuts to unnecessary and wasteful pentagon spending.

please, mr. president, do not yield to outrageous republican demands that would greatly increase suffering for the weakest and most vulnerable members of our society. now is the time to stand with tens of millions of americans who are struggling to survive economically, not with millionaires and billionaires who have never had it so good. respectfully yours." so that is the letter that is on my web site at sanders.senate.gov. i would hope -- i know we have many thousands of signatures already. i would hope we have more. if people would rather go to the white house web site and do that, that would be important. but the main thing here is that the president has got to know that we will not accept a deficit-reduction package that just comes down heavily on working families. and i would say, and the reason i must, i raise these issues

today, mr. president, is i am, frankly, very worried because we have gone through this negotiating process two times in the last six months, and that is why we need the american people to weigh in on this issue. in fact, we have seen this movie before. the republicans led by their extreme right wing have been successful in getting their way because of their refusal to compromise and their willingness to hold the credit and economic security of the american people hostage. as many people remember, in december the republican leadership was prepared to hold the middle-class tax cuts and unemployment benefits hostage in order to extend the bush tax breaks for the top 2%. and as we all know, the republicans won. and, as a result, over $200 billion was added to the deficit over the next two years. not only did the bush tax breaks

of the wealthy get extended, they got a reduction which affects the top .3%. the bush tax cuts extended the tax credit and cost us very, very substantially. mr. president, it is not just the bush tax cuts that were extended, in march of this year you will remember that our republican friends said that unless we made very significant cuts, the republicans were prepared to shut down the government, disrupt the economy and deny paychecks to some 800,000 federal workers if they couldn't get their way. that's what they said. we're going to shut down the government unless you make these draconian cuts. one of the cuts that i was very disturbed about, among many,

were $600 million to build new community health centers which will keep people alive and in the long run end up saving money by keeping people healthy. there were other draconian cuts as well. they also cut the pell grants, making it harder for students to go to college. the point is they acted as bullies, and they said if we don't get our way, we are prepared to shut down the government. and now we're back at it again. this is part 3 of the act. part 1 was whether or not the middle class would get tax breaks. republicans won. part 2 was whether or not the government would be shut down. republicans won. they got almost everything they wanted. here we are today in the biggest act of all, act 3, and the question is whether the republicans will in fact not raise the debt ceiling. and if they do that, it is quite possible that not only our

country, but the entire world might be plunged into a major financial crisis. and that is what they're threatening. if we don't get everything we want, we're prepared not to pay our government's debt for the first time in the history of our country, prepared to see interest rates go up in a very fragile global economy, prepared to see more and more instability. mr. president, in many ways the republicans here in washington are acting like schoolyard bullies. and as we know, bullying is a very serious problem in our schools. every educator worth his or her salt will tell you that when you're dealing with a bully, you must not give in to their tactics or tolerate their temper tantrums or allow them to hurt innocent people. you have to deal with them sternly and consistently. you cannot allow them to win by dictating the rules of the game

and trampling over everyone else if they don't get their way. mr. president, we have a serious deficit problem that must be solved. no one would deny. but it must be solved in a way that is fair, in a way that calls for shared sacrifice. mr. president, let me conclude by suggesting to you that the american people are concerned about the deficit, but they are also concerned about the economy, and they are also concerned that so many of our people of all ages in all parts of this country are hanging on economically by their fingernails. and the american people understand that it is just not fair, not fair at all to come down on people who are already hurting and leave unscathed the

wealthiest and wealthiest people in this country and large, profitable corporations. so what i would say today to the president of the united states, mr. president, stand tall. do not yield to republican blackmail. stand with the vast majority of the american people who believe that deficit reduction requires shared sacrifice; that everybody makes a sacrifice, not just working families, not just the elderly, not just the sick, not just the poor. with that, mr. president, i would yield the floor, and i believe note the absence of a quorum. the presiding officer: the clerk will call the roll. quorum call:

a

the presiding officer: the majority leader. mr. reid: i ask unanimous consent the call of the quorum be entertainment natured. the presiding officer: without objection. mr. reid: i ask unanimous consent the senate proceed to h.r. 2279. the presiding officer: the clerk will report. the clerk: h.r. 2279, an act to amend the internal revenue code of 1986 to extend the funding and expenditure authority of the airport and airway trust fund, and so forth and for other purposes.

the presiding officer: without objection, the senate will proceed to the measure. mr. reid: i ask unanimous consent the bill be read three times, passed, the motion to reconsider be laid on the table, there be no intervening action or debate, any statements relating to this bill be placed in the record at the appropriate place as if read. the presiding officer: without objection. mr. reid: i now ask consent that we proceed to calendar number 57, s. con. res. 15. the presiding officer: the clerk will report. the clerk: calendar number 57, s. con. res. 15, concurrent resolution supporting the goals and ideals of world malaria day, and so forth. the presiding officer: without objection, the senate will proceed to the measure. mr. reid: i ask unanimous consent that the demint amendment to the concurrent resolution be agreed to, the concurrent resolution as amended be agreed to, the preamble be agreed to, the motion to reconsider be laid on the table, there be no intervening action or debate and any statements relating to this matter be placed in the record at the appropriate place as if read. the presiding officer: without objection.

mr. reid: i now ask unanimous consent that we proceed to s. res. 217. the presiding officer: the clerk will report. the clerk: senate resolution 217, calling for a peaceful and multilateral resolution to maritime territorial disputes in southeastern asia. the presiding officer: proceed to the measure. mr. reid: eup further ask the resolution be agreed to, the preamble be agreed to, the motion to reconsider be laid on the table, there be no intervening action or debate, any statements relating to this matter be placed in the record at the appropriate place as if given. the presiding officer: without objection. mr. reid: there are two bills at the desk due for second reading. the presiding officer: the clerk will read the titles of the bill for the second time. the clerk: s. 1276, a bill to repeal authority to provide certain loans to the international monetary fund and so forth and for other purposes. h.r. 2021, an act to amend the clean air act regarding air pollution from outer continental

shelf activities. mr. reid: i would object to further proceedings with respect to these two bills. the presiding officer: the objection is heard. the bills will be placed on the calendar number under the provisions of rule 14. mr. reid: h.r. 1249 has been received from the house and is at the desk. the presiding officer: the clerk will read the title of the bill for the first time. the clerk: h.r. 1249, an act to amend title 35, united states code to provide for patent reform. mr. reid: i would ask for its first reading. has that been done? that's what we just completed. i would then ask for second reading but object to my own request. the presiding officer: the objection is heard. the bill will be read for the second time on the next legislative day. mr. reid: mr. president, i ask unanimous consent that three of senator bingaman's interns: paco

veneri and elizabeth reece be extended privileges to the tphraofrplt. the presiding officer: without objection. mr. reid: i ask unanimous consent that when the senate kphraoeuts -- when the senate completes its business today it adjourn until tomorrow morning at 9:30. following leader remarks, the senate proceed to executive session under the previous order and that following the disposition of the cole et cetera nominations, finally at 2:15 p.m. the senate resume consideration of the presidential efficiency streamlining act. the presiding officer: without objection. mr. reid: the first vote will be tomorrow afternoon on james cole to be deputy attorney general. additional roll call votes are expected tomorrow. mr. president, if there is no further business to come before the senate, i'd ask that it

stkwr-rpb under the previous order. -- that it adjourn under the previous order. the presiding officer: the senate stands adjourned until senate stands adjourned until

also called juvenile diabetes. at this hearing the center calls for more research funding for children with type one diabetes. actor kevin kline and an fda official. this runs two hours.

>> that hearing will come to order. thank you very much for being here. this is one of the afternoons and days that we look forward to. i will say that the younger people here in front are mucha better behaved than the older people who usually fill this room. i really appreciate it. as aa point of personal privileg at do want to note the presencer of secretary of war of edward stain from thea lincoln cabinet, oh, no, that is kevin kline. [laughter] [applause] [applause] if you haven't seen the movie, the conspirators, it is an extraordinary movie., kevin is really brilliant in the role of secretary of war. i guess it is not a violation of our senate ethics rules to plug

a good movie.ood movie. by historical content. [laughter] today as i have traditionally done with a good cause, going to turn the german's cowal o2 senator collins and recognition of her longstanding leadership on behalf of diabetes research particularly for children, and her truly passionate advocacy for federal support for that research. so, without further ado, i give the devil to my friend and colleague, the great senator from the state of maine, susan collins. [applause] thank you. thank you so much, mr. chairman. i am particularly grateful that you are allowing me to conduct this hearing. this issue is near and dear to my heart, and this actually

represents the sixth hearing of the children's congress that i've been privileged to conduct. i very much appreciate the opportunity to hold this hearing to examine what is often a devastating impact that the juvenile diabetes has had on an estimated 3 million american children and their families. i also want particularly to welcome our distinguished witnesses and the more than 150 children who have traveled to washington from every state in the country and from around the world to tell congress exactly what it's like to have diabetes,

just how serious it is and why a this so important that we work together to fund the research necessary to find a cure. and i want to give a special welcome to the delegate from maine who is here, 14-year-old caroline jacobs. she will be testifying later. i want to also recognize senators shaheen who has joined us this afternoon and i think senator lautenberg is going to becoming as well. both of them have a longstanding commitment to issues affecting children with diabetes and their families. senator shaheen is also my co-chair on the senate and diabetes caucus, and her daughter has been the chair also

with the juvenile diabetes research foundation to help put together the children's congress. so we are very delighted she could join us as well as our colleague, senator akaka and senator brown. there will be others coming in and out today. senators have so many different duties and obligations but the daycare a lot about this issue and others will be dropping by as well. i do also want to acknowledge someone who was not able to be with us for the first time since the children's congress and that is mary tyler moore. i talked to mary yesterday and she sends her best wishes. she's recovering from some surgery. she's doing really well. but i know we miss her but she's here in spirit and she's delighted that another famous american, kevin kline is joining

us today. thank you, kevin, as well. diabetes is a lifelong condition, and it's one that does not discriminate. it affects people in every age, race and nationality. it's the leading cause of and not what updated medical problems. moreover, it says to me taibbi these accounts for more than $174 billion of the nation's annual health care cost and one out of three medicare dollars. medical cost for a child type 1 taibbi these are six times higher than the cost for a child without the disease. these statistics are overwhelming. but what really motivated me to devote so much energy and time into this issue was meeting with families whose lives have been

forever changed by diabetes. i will never forget has a new center in 1997 meeting with the family whose son had diabetes. this was the first time i really learned about type 1 diabetes and this one little boy looked out to me and said he wished he could just take one day off from having diabetes. just one day, his birthday or christmas. but of course, for those who have diabetes, you can never take a day off. but it doesn't mean that you cannot accomplish great things. and i am delighted to learn many of you yesterday had the opportunity to meet with supreme court justice sonya sotomayor and hear of her personal story.

but it's so important that to travel to washington today to tell your story. you put a human face on all of the statistics and helpless better focus on what congress can do to better understand and ultimately find a cure for this terrible disease. in the individuals with type i diabetes, the body's immune system attacks the pancreas and destroy his the shells that produce insulin to read an average child with diabetes will have to take more than 50,000 insulin shots in a lifetime. our particular concern is the fact that the incidence of type i diabetes is increasing particularly in children under the age of four. while the discovery of insulin was a landmark breakthrough in

the treatment of diabetes, it is not a cure. people with type 1 diabetes face the constant threat of developing life-threatening complications and can face the reduction in their quality-of-life. but thankfully there is good news. since i founded the senate to diabetes caucus in 1997, funding for diabetes research has more than tripled, and now approaches more than a billion dollars this year. and as the consequence, we have seen some encouraging breakthroughs. and we are on the threshold of a number of important discoveries. i talked today with several of you who have insulin pumps for example, advances in technology like continuous glucose monitors are helping people with

diabetes, children control their blood to glucose level which is key to preventing complications. we are also moving closer to our goal of an artificial pancreas. it would revolutionize diabetes care. an artificial pancreas is an external device that people with type 1 diabetes could use to do with their bodies will not come in and that is automatically control both high and low blood sugar levels of around the clock. this new technology has the potential to dramatically improve the health and quality of lives for individuals with diabetes. and we are going to hear from federal officials today who will tell us about the important clinical trials that are going on that are so promising.

the fda has played a pivotal role in moving this research for word and making the artificial pancreas one of its critical paths initiatives. we are making progress in the battle against diabetes, but this is no time to take your foot off the accelerator. we have two choices. we can sit back and continue to pay the bills and endure the suffering, or we can aggressively pursue a national strategy aimed at touring this disease. thanks to your efforts and you're coming to washington, there is increasing understanding and support in congress for diabetes research funding. last year we were able to pass legislation to extend the

special diabetes program for two additional years and that program represents more than one-third of our federal commitment to diabetes research. as such it is critical to our efforts to find better treatment, a means of prevention and ultimately a cure. so welcome to washington. we are glad that you're here. senator lieberman, thank you. thank you, senator collins, and really what i want to say is amen to everything you said. so i will be brief. use it at the beginning i look forward to these hearings every session, and i do because they are so constructive in a city in

which in a government in which too often too little happens that's constructive these days, this is a cause that unites people across party lines and has enabled us certainly in recent years to come together to be supportive of diabetes research and to help facilitate some of the really miraculous advances that have occurred in dealing with diabetes and our time. the fact that you children are here, young people are here is the most important thing of all because you are the best advocates for this cause. first off, you show how well you were doing triet to show everybody how well you're doing dealing with diabetes but the second thing is you make us all want to make the investments that are necessary to make sure we not only better treat

diabetes but really, in your lifetime to have a cure for diabetes, and it's with that sense of optimism but i'm really honored to welcome you and ought of the witnesses here today, and thank the chair, senator collins. >> thank you, mr. chairman, mr. chairman, madam chairman. [laughter] cementer akaka? >> thank you very much, senator collins. i deem it an honor to join you hear and to say thank you very much for sharing this important hearing again on type 1 diabetes and to share a commitment and passion in trying to move this

along to improve the lives and quality-of-life for young people and people of the country and i also want to welcome you and our distinguished panelists to this hearing who have been so committed to this issue and a very special aloha to those children's congress delegates waiting to testify and those an audience all of you seated here. these are courageous young ambassadors who have traveled from all over the country and the world to educate us to share their stories of their own experiences to bring a human dimension to the policy debate. this shows how critical research

and support is for diabetes and the hope for a cure. maybe it is a significantly held a problem in my home state of hawaii, and it is an increasing challenge for the nation. it is an issue that we will look at in the indian affairs committee. will be part of the legislation that i plan to introduce, and it is a subject of the ongoing budget and regulatory policy debate. in this context, i am proud to support the development of the artificial pancreas, and i will continue to support funding for research at nih which gives the chance for better detection and treatment and hope for a cure.

all the more reason i am so pleased to see the children here every two years. they remind my colleagues and me about the struggle of living with type 1 diabetes and the importance of supporting diabetes research. and i would like to extend a special thanks to aaron, a child away from honolulu with his mom to meet with me today. if you are sitting here please just hold your hand. there you go. yes, thank you, aaron, from coming of the way from hawaii. i look forward to continuing to work with all of you to improve the lives of individuals with diabetes. glad to be with you and joining you in this. think you very much. thank you, senator. [applause]

senator brown? >> thank you, madame chair, mr. chair good to see a lot of the kids here and their families coming out and supporting i had the honor of having to have met before young people from massachusetts jackson savage, john thune deals and joshua fish who i see some of them out there in the audience and give a lot of good information i've been aware of our families have been working on long before i got to washington so i want to thank you for your leadership and i look forward to hearing of our witnesses and what you're to be bouncing back and forth but i look forward to staying as long as i can. >> thank you, senator. senator shaheen, i mentioned senator shaheen is the co-chair with me at the diabetes caucus and the head of the special connection to this particular congress, and we are delighted to have you here.

>> thank you, madame chair and to senator lieberman and both of you for holding this hearing today. i have a statement i would like to support for the record but i know we want to get to our panelists, so i just want to take a minute to introduce my granddaughter, a,i was a delegate at the children's congress, thank you and her mother, stephanie and father, craig cochairing the children's congress this year and also want to recognize abigail and her mother jeneane from merrimac hampshire. thank you both for being here as well and to all families and all the delegates who are here today. i'm very happy and proud and be happy to join you and advocating for research for a cure for juvenile diabetes and also moving forward as quickly as we can at the development of an artificial pancreas. so again, thank you all very much for being here. thank you. [applause]

>> senator lautenberg we are delighted that you could join us again this year i mentioned in my opening statement that you to have a personal connection in leadership in this area. estimate a granddaughter also i'm fortunate enough to have come and to the chairman and the chairman for inviting me today. and i appreciate the chance to work with you, senator lieberman but particularly with susan collins the colleague from maine. she has been so diligent, so persistent, so determined to help our country by making sure those with diabetes can conduct their lives with a decent attitude of participation in all of the activities, and i learned it when i heard the news a

couple of years ago that my granddaughter who was here during the obama commemoration for the inauguration, and i saw that she looked pale. i saw that she seemed tired, 13 years of age, 12 actually, and i said to my daughter and there's something wrong with maddie and she said i don't think so, but some signs tell me we have to get to the doctor, and therefore who they did that come in and her look from thai year and pale , we visited her in the hospital a day after she got back to florida and she had first insulin she was bright, positive, hopeful, and i thought of this devastation that came upon us when we learned that she had diabetes, and i can tell you that kid of mine is on a soccer

running for the state championship in florida she's never too tired to take on it and she's been an inspiration to my life just as all of you are an inspiration here. you don't know how much you do for us. you know we try to do things for you but you do more for us when we see your faces and smiles and see your parents and know that life is good for you and we are going to keep working to make it better and i think our friends here and all of my colleagues for participating in this hearing. thank you, susan collins. >> thank you, senator. [applause] >> senator pryor, welcome. >> thanks for having me. i think everybody understands this now but we want to make sure everybody in the stands the trend is adequate you haven't the guts get one more hand.

[applause] and i really just want to say one thing. i know davis more from arkansas is here. thank you for being here and all of you in the blue shirts, if you are making a difference. thank you for coming to washington and fighting a good fight. it is certainly a fight worth having and thank you for all the things you represent and are going to accomplish. thank you. >> thank you, senator. [applause] >> leading off the first panel this morning is academy-award winning actor maaskant long time jdrf advocate kevin kline. one of our country's finest films and stage actors as senator lieberman mentioned mr. kline may have been virtually unrecognizable in his recent appearance as edward

stanton of the secretary of war in the movie the conspirator. but he is no stranger to us he testified before our committee ten years ago at our 2001 hearing, and i am delighted that he's made a return performance and encore i guess i will call it, and because i look forward to hearing his perspective on the progress that has been made during the past decade and the road ahead. so welcome. we are delighted to have you here. >> [inaudible] hello? talk, he says. time remaining? [laughter] a bitter talks quickly. senator collins, thank you, senator lieberman, thank you and for the mice mention of the conspirators and my performance

as a historical figure. members of the committee, thank you all for inviting me to appear today with this distinguished panel and a mixed this collection of such remarkably policed self possessed quiet but ultimately very vocal delegates. ten years ago as you mentioned i had the honor of joining mary tyler moore and the 100 plus delegates at the 2001 jdrf congress. since then, i am happy to report that we have made remarkable progress in understanding this disease. we are many steps closer to a cure and even as we are gathered here today, new tools are being developed to improve the day-to-day management of type 1 diabetes but we still have a way to go which is why we are here now. not only championing the science, but pushing to

accelerate programs. today these great young delegates are getting the attention that they so richly deserved. but i would like to take a few moments to recognize all of the parents and siblings and other special people that these young advocates have brought with them today. they know firsthand the challenges we face as we shepard our children and loved ones through life with the added burden of diabetes. when a child is first diagnosed with type 1 dalia these the parents are thrust immediately to the additional role of doctors, nurses, nutritionists and even psychologists. they are on duty 24 hours a day, seven days a week, 365 days a year monitoring the child's blood sugar levels, physical activity counting carbohydrates in their meals and snacks, calculating insulin dosages,

giving injections as well as managing the emotional stress which come from dealing with the daily rigors of this disease. each day, as i am sure these children will testify, brings its own unique challenge to control blood sugar levels. even with the best of plans and the use of the latest technology, it's not unusual for parents routinely to wake up in the middle of the night to check their children's blood sugar to make sure it didn't become too high or too low to result in a seizure or a coma or worse. these blood sugar emergencies are all too common and a number of parents here have had to call 911 to save their children's lives. many parents have become their children's advocates in the fight to cure diabetes by joining jdrf. as jdrf's national walk to chair person i have a great pleasure of rallying people across the country to join me the jdrf walk

to cure diabetes and i am happy to report things to the outpouring of enthusiastic support, we have raised millions of dollars worth of a walk and jdrf has put this money to work in a direct and efficient manner to support research for better treatment, prevention and ultimately for a cure for type i diabetes. the federal government has also played a critical role in the fight to cure diabetes in particular with a strong bipartisan support for the special diabetes program. i thank you, senator collins, for your leadership and your colleagues in the senate and the house who recognize the great return on the investment from the special diabetes program and supported the two year 300 million-dollar extension this past december. together, jdrf and the federal government have made and will continue to make powerful

partners in advancing research to cure, treat and prevent type 1 diabetes. since i testified here before this panel ten years ago, more than 40 of the jeans have been discovered which put people at risk of type 1 diabetes. numerous therapies to halt the autoimmune attack which causes type 1 dalia these are being tested in human clinical trials. they're a piece have also been shown on only to halt the progression of dietetic disease to improve the vision in those who already suffer from it. and finally, the artificial pancreas has gone from being merely a theory to a cutting edge technology that has been shown in early trials to prevent dangerous low and high blood sugars. apart from finding a cure from the artificial pancreas represents a watershed moment in the management of diabetes, and happens to also be the parent's

dream come true. imagine, if you will, going to bed at night without having to worry about dangerous night time high or low blood sugar levels. or knowing that your child will have a great day at school without the burden of pricking his or her figure come accounting carbohydrates, taking the right amount of insulin and treating high and low blood sugars or just getting so caught up in being a kid and forgetting to do some of these things and coming home from school dangerously ill. this will come imagine knowing your child will live a long and productive life. since these artificial pancreas technologies have the potential to keep him or her healthier longer, forestalling or completely circumventing the devastating complications until a cure is found. i know the food and drug administration has made the artificial pancreas a priority, and i commend the commissioner for her leadership.

but there is more that the fda needs to do. many of these children here today are in fact wearing the components of what would ultimately comprise an artificial pancreas, namely insulin pumps that deliver insulin as well as continuous of glucose monitors, which give sugar readouts every few minutes. the challenge that we face now, however, is to control -- to get these devices which don't yet work together automatically, to get them to sort of talk to each other and to control blood sugar levels. in other countries there are devices now available that take the first step in this process buy automatically shutting off the insulin pump when someone is going low. this is an important step, one that we need to take in the united states right now.

and we can do more than jdrf and federal law funded research have in hospital settings tested artificial pancreas technologies to automatically turn insulin both on and off, and the results have been overwhelmingly positive. the next step is testing these artificial pancreas devices and real-world settings. to do this without delay, however, the fda needs to provide common needs to provide clear and reasonable guidance. many of the world's best diabetes researchers and leading clinician organizations have joined together with jdrf to propose artificial pancreas guidance to the fda. and the majority of the senate and house urged the fda to get this proposal immediate consideration. we now need the jdrf fda to act. parents out every night worrying

every day about their children simply cannot afford to wait any longer. it is past time for the artificial pancreas technology to be tested in the real world settings. we urge and implore of the fda to issue a draft guidance for public comment on the artificial pancreas so that our outpatient trials can begin and the burdens of type i diabetes can be lifted from the millions of americans as soon as possible. thank you for the opportunity to participate in the hearing today and i would be pleased to answer any questions. [applause] >> thank you very much for that excellent testimony. we are going to do questions for the whole panel after we hear from the rest of the panel.

so next, we will hear from dr. griffin rogers who is the director of the national institute of diabetes and digestive and kidney diseases at nih. he will be able to bring us up-to-date on the advances and researchers, and i also hope that he will provide some examples of the research that is specifically supported by the special diabetes program. dr. rogers, thank you. >> thank you very much. tester chairman, senator collins, members of the committee, as the director of the national institute of diabetes digestive and kidney diseases or niddk i think you for testifying ought to be to this hearing on diabetes and on behalf of niddk and the other institutes on behalf of an ideal for the national institutes of health, i am pleased to report

that we are vigorously pursuing research to prevent, treat and ultimately cure type 1 diabetes and its complications. through collaborative and coordinated research efforts with our partners, including the juvenile diabetes research foundation, with the support of the special statutory funding program for type i diabetes making critical studies and critical steps towards these goals that i outlined. before i highlight some of that exciting advances, i would like to acknowledge the important contribution of my fellow witnesses. here in spirit near you continue to motivate us with your unwavering devotion to improve the lives of others with type 1 diabetes. kevin kline, you raise awareness of the disease and to promote efforts towards the cure. i am also pleased to share the table today with dr. zimliki who

will describe the complementary efforts of the fda to at the of the artificial pancreas. i also like to acknowledge the children, parents and families who will testify and proudly representing their states and the many other americans with type 1 by moody's. many of you have participated in clinical trials to help improve diabetes care not only for yourself, but for future generations. we are inspired by your dedicated efforts and your enthusiasm. now, research and type 1 diabetes has made a tremendous impact on the health and quality-of-life of people with this disease. i will reference to the handouts during my testimony to illustrate this point, and of these handouts are attached to the copies of my written testimony. on the first hand out, a bar graph shows the survival rates for people with type i diabetes has dramatically improved over time where people diagnosed

flexible in the 1950's represented by the blue bar on the floor level on the side of the graph to read only about 70% survived for 25 years worth of the disease. this number has dramatically increased so about 95% for people diagnosed in the 1970's represented by the purple are on the far right side of the draft. look at even brighter for today's children due to improvements in diabetes care and technology. still, of the burden of living with diabetes, as my colleagues mentioned is enormous comes of it is critical to build on progress to find ways to prevent and cure the disease. on the second hand out, you will see that even before type 1 had diabetes becomes apparent, the immune system of people who will develop the disease are destroying their insulin producing beta cells, leading to

a decrease in the data cell mass, and i will describe how the in on the beach is focusing our research on different stages of the disease progression. now, as indicated on the far left of this graph, understanding the causes of type 1 diabetes is essential towards preventing the onset of immunity. preclinical sign of the disease and other diseases itself are significant progress has been made in unraveling the genetic cause of the type i diabetes as was mentioned just a few years ago we only had three genes we understood contributed to the risk of the disease. today due to the efforts of the type 1 diabetes consortium and other researchers, nearly 50 genes have been identified. but we know that there are likely factors that exist in the environment that interact with these genetics to turn disease risk and to disease reality. and because of the genetic risk

for type deacons type 1 dalia visas well characterized we can identify those at risk and follow this. this has allowed us to embark on bold, longer-term systematic studies to identify these environmental factors. this study has enrolled over 8600 newborns with high genetic risks for the disease, and we plan to follow them for 15 years. we will be collecting biological samples and information about their lives, identification comfortable, of an infectious agent that triggers this auto immunity could lead to a vaccine to protect against this disorder. ..

today blood tests can accurately identified relatives of people with diabetes who are at higher moderate risk of developing the disease within five years. this important advance in a bold type i diabetes to launch clinical trials of promising prevention strategies to stop the auto immune attack. it's also important to identify ways to halt or reverse disease progression soon after to preserve any remaining data pells and collaboration with th immune tolerance network trial net is also conducting trials od promising therapy in newlys neta hoagnosed patients.e resech s the third hand out continuesn along the spectrum established type one diabetes.

and a high priority for this stage is a development of new tools and technologies to help people improve their blood glucose control because they can reduce diabetes complications by up to 70%. this is certainly an artificial pancreas that automatically links with close monitoring with insulin delivery to make a positive impact on people's health and their quality of life. and i.d. decay is supporting innovative, innovation and technology critical to the development of an artificial pancreas working closely with our partners at the fda. we are pursuing testing pancreas technology and ensure that they are safe and effective. in a recent advance scientist develop and are testing a by hormonal artificial pancreas. a counterbalancing hormone to more finally reproduced the

activities of the human pancreas. another recent study cometh researchers looked at overnight closed loop insulin delivery country -- following two different real-life andrew scenarios, testing close loop technology in real-life situations. it is really a key step toward moving this technology out of the clinic and into the real world. a major goal of research at the next stage shown in purple is to investigate ways to replace the destroyed data cells and restore and to eyelid transplantation. in a clinical islet transplantation contortion misconduct king trials. science is like those of a beta sale biology consortium are pursuing strategies to replace islet cells by either growing cells in laboratories or for transplantation into people or by expanding their remaining beta cells or by posting other

types of cells in the pancreas to become beta cells. finally, tilt prevention of our cure for type one diabetes is possible research towards preventing, resting in reversing the complications of the disease is critically important. shown on the far right of that graph, just recently we sell the saw the biggest advance in diabetes in 25 years. at landmark study from the retinopathy clinical research network found that patients who received a combination of a drug and standard laser therapy shows substantial visual improvement after one year. advances like these in diabetic complications also benefit patients who have type ii diabetes who were at risk of these complications as well. hundreds of thousands of individuals have participated in research supported by the

special diabetes program irca remarkably, nearly 30 years after one pivotal study began, about 95% of the participants in the muslim arc trial showed that glucose control to radically continue to participate in a follow-up study known as edict and as a result of their commitment as long-term investment in research continues to identify ways to improve the health of people with diabetes. i'm grateful for the opportunity to share with you just a few examples of the many recent advances in ongoing research in type 1 diabetes. we continue to be inspired by the dedicated efforts of the individuals affected by type 1 diabetes and by the organizations like jdr app that represent them. we look forward to continuing our partnership with the jdrf and her sister federal agencies on research to combat type 1 diabetes and competitions and we

will continue to be diligent in our fight against type 1 diabetes to help all the children here and the many americans whom they represented a and we will strive to improve their quality of life with an ultimate goal of hearing this disease. thank you mr. chairman and senator collins for your leadership and calling for this hearing to continue to bring attention to the importance of type 1 diabetes research and for your continued support of nih research. i will be pleased to answer any questions that you might have. [applause] >> thank you dr. rodgers. our last witness on this panel before we hear from the children is dr. charles zimliki. he is the chair of the food and drug administration, artificial pancreas critical path initiative. as you can see there is

tremendous interest and excitement about this research and technology and i look forward to hearing your statement. >> i share that excitement as well. madam chairman and members of the committee, i am dr. chuck zimliki located within the center for radiological health of the fda. i would like to think of the committee for the opportunity to discuss the artificial pancreas system and what fda is doing to assist in the development of these critically needed and potentially life-changing devices. as a person living with type 1 diabetes, i am personally committed and professionally committed to seeing this important novel medical device approved in the u.s.. i just want to go off-line and say mr. kline i furley support the postal and issuing guidance i believe the fda will submit guidance for all types of artificial pancreas before

december of this year. [applause] [applause] >> i still have six minutes ago here. [laughter] diabetes is a disease that affects the entire family, especially when a child is diagnosed. i know this because i was diagnosed with diabetes when i was 13 years old. when i was diagnosed the technology was a great deal different. they were just coming out with glucose meters and it took much longer than it does today to obtain a blood glucose measurement.

technology has come a long way and i'm very grateful for that. but even now, today's technology, we still must prepare fingers to test for blood multiple times a day in overtime that can really hurt. i am sure you kids can attest to that. we must also calculate insulin doses administered necessary insulin via syringes or infusion pumps to lower blood glucose and as always we have to be prepared for the inevitable lows and highs associated with diabetes. i admit, it is really tough being a diabetic. paul great strides have been made in diabetes management current treatment is consonant pervades all aspects of a persons life presenting a particularly arduous burden for children and their parents. an artificial pancreas system is an innovative device for treatment of type 1 diabetes that once fully developed will automatically monitor blood glucose and administer appropriate insulin doses. this life-changing technology will positively impact diabetic

patients health and quality of life. as a person with diabetes i'm acutely aware of the benefits and artificial pancreas system will provide. i say well because i'm highly optimistic that industry, researchers and fda will bring this device to market. and artificial pancreas system will allow people with diabetes, especially children, to live an active life without the constant need to address glucose levels. pauline know the potential benefits are enormous and artificial pancreas is a significant device many presents the potential for serious risk to the health, safety or welfare of the patient. if not properly design, use of an artificial pancreas device in an outpatient setting can place patients at significant risk because the device controls the administration of insulin. as such an investigation exemption or ide from fda is needed to allow the

investigation device to be used in a clinical study. currently fda has approved over 17 clinical studies for artificial pancreas systems at various levels of development and we have seen promising results. fda is helping advance the development of an artificial pancreas system by prioritizing their review of ide studies fostering the discourse and, shortening study began with the times and providing clear guidelines that passed the market for industry. in 2007 fda created artificial pancreas critical path initiative bringing together a multidisciplinary group assigned to clinicians from fda and nih. one of the major goals of this initiative is to identify roadblocks and possible solutions to streamline the regulatory process. a shining example of this effort was how fda worked with the developer of a software program so that researchers working on an artificial pancreas system could test control rhythms and use the results to support the

regulatory submissions. this important software tool enables researchers to quickly test artificial pancreas control algorithms and is accepted in places of costly and time-consuming animal studies. this effort saved investigator six months to a year and expedited the transition of human trials. fda also encourages researchers to contact the agency early to discuss clinical study lansing get an informal feedback to improve their studies and to facilitate the review process. this quick informal feedback and help investigators develop better and more complete study plans for fda review. when investigators submit their final study plans, fda gives the submissions these submissions the highest priority. and works with investigators to move them and efficiently through the review process. questions in research challenges are resolved helping researchers start their studies and there. fda guidance and industry

standards help manufacturers and researchers understand the minimum requirements for making a device that is safe and effective. this helps them make the best use of resources and streamlines the regulatory review process. we agree with jdrf another set guidance in the industry is useful for product development. on june 22, fda issued draft guidance that will help advance development and approval of an artificial pancreas system to treat type 1 diabetes in the u.s.. this guidance documents an early version of an artificial pancreas system known as the algeo system. they'll just system can help reduce or lessen the severity of hypoglycemia by temporarily reducing or stopping the delivery of insulin. patients using the system still must test their glucose levels on a regular basis with the glucose metering. the draft guidance provides recommendations for those planning to develop and submit for fda approval an application for a system.

fda is seeking input from industry researchers and clinical community on the draft bill specifically the agency is interested in feedback about the types of clinical studies that should be conducted and what their target outcome should need to demonstrate safety and effectiveness. your input is very welcome. fda is also working on the second guidance as i had earlier discussed. fda has been working with research communities such as jdrf to expedite this guidance and we promised the publication of the draft guidance by the end of this year. early december. finally, fda is working with nih and other interested parties in developing the next artificial pancreas workshop which will focus on developing better technology for creation of a more accurate and reliable artificial pancreas system. these are assisting kids that -- you can put it on and not worry about it and i can't wait for

that day. if he is fully committed to the development of an artificial pancreas to meet this critical help me. is the goal of the agency to provide a clear path for manufacturers to provide people with diabetes with innovative safe and effective medical devices to treat their disease. madam chairman this concludes my formal remarks and i would be pleased to answer any questions the committee may have. [applause] >> thank you so much for your testimony. we are going to do a six minute round of questions so that we can get to the next panel. we could keep you here all day. dr. zimliki it is great news that you have given to us today and i saw the guidance on monday about the draft guidance. in early may, 59 of us wrote to

you, signed a letter that i spearheaded, that encourage then encourage the fda to move forward with issuing guidance that would enable clinical trials for testing the artificial pancreas to move from inpatient to an outpatient basis. does this guidance help us along to achieve that goal of moving to the outpatient guidance? >> yes, indeed it does. this is the complete package guidance. this will help investigations, get them approval for the clinical studies in the clinic and it outlines what type of information the fda needs to assure safety as we transition from the in clinic to the outpatient settings. >> and on a related question for you, i have heard, and there are some delegates from canada here today, that the low glucose

suspense system technology is available now in canada and other parts of the world. could you explain to us, and i'm not trying to put you on the hot seat, though maybe i am trying to put you on the hot seat -- but, why isn't this available here if it is available next door in canada? >> well, it is hard to draw a comparison across the various regulatory agencies, actually across the world. the fda has to operate within u.s. law which states medical devices must be safe and effective. i will give you an example. the european union said medical devices need to be safe and perform. that might not sound like a big deal or a big difference but there is a significant difference between the two. i will use this as an example. this is going to be a long answer, i am sorry senator collins.

to evaluate the performance, all you need to do was show that the insulin pump shuts off when the sensor reads low. now that is a perfect engineering question that can be tested on the bedside and it is an easy thing to do. fda agrees that type of performance is needed. what the fda also need for effectiveness is to know what happens to the patient when the pump actually turns off. that information is critical because it allows the prescribing clinician to look at the information that is provided in that clinical study and determined whether or not their patient actually can use this device beneficially. so with regards to the deo system i will say medtronic and fda has been continually working together and and i believe the ongoing study right now provide sufficient safety data within the u.s. and it is the hope of the fda that the safety data will allow the transition to an outpatient and finally approval of that device.

>> thank you. dr. rodgers, last year congress passed legislation extending the funding for the special diabetes program through september of 2013. how important is it for congress to do multiple years as opposed to year-to-year renewals of funding? does that have an impact on the kinds of studies that you can fund? >> senator we were very pleased to see the multiyear renewal of special diabetes program grass through fiscal year 2013. the multiyear renewal greatly improves the planning process that goes on at idd k.. for example many clinical studies take multiple years to perform and it would be very difficult if not impossible to start such a multiyear clinical trial without knowledge of whether the funds will exist in future years to continue those

types of funds. one area that we are absolutely looking at is to bring new people and new talent into this field. for example in the artificial pancreas, we have obviously very dedicated and talented clinicians and we have people in the industry but what needs to link them to her as my colleague dr. kevin kline says to actually put it together are bioengineers. so with this multiyear funding where trying to put in training efforts to bring bioengineers into this field and training occurs over a long time horizon and there for multiyear funding is also critically important. one final thing that i would say is that, as we move towards artificial pancreas, clearly we would recognize that there might be some issues related to compliance so now we are trying to get people give people who have been previously engaged in

behavioral science to tell us what particular challenges we might face. we are trying to get them involved in research in diabetes. so, training and bringing in new talent is critically important in multiyear funding greatly assists in that regard. >> thank you. mr. kline, you mentioned in your statement that when there is a diagnosis of type 1 diabetes, it affects the whole family and involves involve the whole family. you also talked about the very different challenges at different ages. could you, having lived with this for quite some time now, elaborate on the impact on the family and the challenges of different ages from toddler to teenager? >> well, it affects the entire entire -- transforms the entire family and it changes with the vicissitudes of the degree of

the age and the various vicissitudes that the disease can go through. suddenly in the teenage years, with the hormones being what they are, there is chaotic glucose levels. >> people are agreeing. [laughter] >> and, as it is a vast improvisation of figuring out how you react to this. it is this the real high number? is this the hormones? not unlike life in that way, trying to find ways for the absolute cause for any particular symptom. but obviously when a child is diagnosed as six months, he can't tell you he is feeling low or feeling high.

it is too horrible to imagine. it does get easier all things being relative and given our human nature and our marvelous adaptability. we can adapt to a surprising number of things. and kids get more and more used to it. get more and more top of it depending on the nature of the child. there are are some type a personalities that are all over their diabetes and can really control them and there are others who are more in denial of that who don't want to be bothered with it, and those days of not having diabetes he spoke of earlier, just one day and sometimes they will take that day even though it is not an officially appointed day for such behavior. but they will take it upon

themselves to. it gets easier and harder, but the thing i find most of all, it doesn't stop. when your child gets over and goes -- older and goes off to college you are still calling incessantly. you were still checking out. you are still worried. you are still make him trips at strange hours of the night to deal with the insulin emergencies. it is moment to moment, hour-by-hour, day to day. it is ongoing which is i think dwight jdrf wants to stress the urgency and the need to keep the research going and gets the artificial pancreas done. i think is these marvelous

children can attest, it is tomorrow. what is going to be here sooner than we would like and we would like it to have it tomorrow or yesterday. >> thank you. senator brown. >> that happens regularly with me. [laughter] it is a conspiracy. [laughter] >> you are not in massachusetts. >> i asked for that. >> that was very dramatic, yes. [applause] >> that is what this button is. >> that was a good stage trick, mr. kline. [laughter] >> senator brown. >> that was perfect. certainly, -- everyone is awake now.

>> how do you follow that? >> mr. kline thank you very much for coming and offering your star power to a cause for just this i think everybody i know has some type of experience whether it is in their own family or their friends, soap really thank you for taking time out of your schedule. i think we all respect you -- your acting ability and what you do with philanthropic causes the thank you. dr. zimliki i have 225 medical device companies in massachusetts and i visited medtronic's and others in the biggest challenge, and i've met with obviously director pam borg and you know my feelings on that. the fact that there is a tremendous amount of delay and inefficiency within the fda. i will say she recognizes that and she's make great efforts to try to streamlined, consolidate and eliminated a lot of duplication. the number one issue i find in massachusetts and i traveled throughout the country as you have a company trying to make a

difference for people like this and marching along with a checklist in the middle of the checklist i have to go back to square one at tremendous cost. i look at those devices improving in ireland and canada and other parts of the country and they are saying to me as a u.s. senator senator why are we being approved here in massachusetts and the united states? [applause] on the one hand, i've been very critical of the fda and its delay in the fact that it is costing. there needs to be consistency, stability and certainty in the process because it is putting at what lank it on development and the ability to find cures. on the other hand i've also been very public in saying thank you to her and the agency for finally realizing that there is a problem in trying to fix it. so i wanted to let you know that and i'm wondering how are you finding the new leadership and

that new process? is it moving along as expeditiously as you would like? it is a softball. [laughter] >> i am due for a promotion too. [laughter] absolutely. yes, absolutely. i believe we have a new leadership and dr. sher and has certainly said that there is room for improvement for the review process by increasing predictability, consistency and transparency and there is an entire action plan associated and didn't place regarding the improvements in the review process. my focus here today is about the artificial pancreas and i am very happy and pleased to know that doctor hamburg and dr. sher and give me the fullest support and we are going to make sure this device gets approved. we are hopeful that this guidance outlines or four

improves the transparency so a company like you reference doesn't go halfway through the development process and have to start back at square one. >> that is a tremendous job killer in my state and brought the country. i think you stated that you want a device that performs precisely and as a unit. what steps are you an taking to ensure the quality of the systems and the clinical trial in your face to guidance? >> just give me one second second here. >> okay. you thought you are going to get easy questions. >> well the face to guidance is really sort of adopting some of the information from jdrf. granted they're face to ideas which i will call the morgue vance artificial pancreas guidance is using some of the information that the clinical panel's recommendation by jdf

submitted. is a three phased approach and the idea would be to understand the device and the clinic and then transition into a more realistic version of home life, except under mitigation or supervision such as the diabetes can. i'm sure most of these people here up into a diabetes camp echo is that correct? thank you. i like you too. and then the last would be the transition, from the transition study to the outpatient and certainly that is the recommendation associated with some of the jdrf recommendations as well as most of the medical community. it is still under development and we will be finalizing finalizing that and you will see the publication december of this here. >> dr. rodgers what is the role in supporting the fda in this process? how do you foresee the role, nih's world changing in the

current month and will you be facilitating the transition to clinical trials with the translational research? >> yes, under the auspices of the diabetes interregional chordata committee we have regularly meet with not only our colleagues at the fda and the cdc and other federal agencies that other institutes within nih that have a role to play in diabetes research. we work very closely with dr. zimliki and his colleagues in an interagency artificial pancreas working group. in fact just a few months ago we held a meeting in conjunction with the jdrf and we are actually planning to have a follow-on meeting in the fall of this year to develop sort of a working understanding of what are some of the challenges, what are the other groups that we need to bring into the question, particularly bioengineers, mathematicians, theoreticians to

try to assist us in moving more expeditiously along this pathway. so, we have an essential role we have been working very closely. this is not only with the fda and nih but the meeting in the fall of this year will also involve a jdrf as is will. >> very well. madam chair, listen you surprise me more and more each day. i wasn't aware until this year that you were advocating for this cause the thank you for that. there will be an opportunity to submit questions to our panel members because i know a lot of folks are. >> absolutely. >> and i want to also say thank you to all the parents and kids they can. i'm going to be bouncing back and forth as i've done so trying to get back with the kids. >> thank you. senator shaheen. >> cannonmack been in chair and thank you to all of our panel is this afternoon. dr. zimliki, as you are aware i

know, i share the frustration that both senator collins and senator graham have expressed about the pace at which the fda has moved on getting the guidance out on the artificial pancreas. i am pleased to hear you say that you expect that to happen by december but i wonder if you could then outlined what the next steps are once that happens on the way to getting approval for the artificial pancreas? >> can you clarify which artificial pancreas type system you are asking about? >> i would think -- i know there are a number of those systems in development and i am interested in seeing something that can be commercially available on the market that will be approved by the fda and be safe and available to my family on all the families who were here. i don't particularly care who

the producer of that system is. >> i was just asking for clarification on the thai. the artificial pancreas have lots of different types. we talk about the deo system which the agency believes is a type of artificial pancreas and that one by far should be on the market sooner than later and i would fully support that. >> i appreciate that. i guess i think for many of the people in this audience, they don't see that as the artificial pancreas that we are really hoping will be on the market. i agree that is a step in the right direction, but as has been pointed out that device is available on the market and other countries and we would like to see not only that available here, but to go to the next step to have a continuous system available for people. >> and so is the question that you would like to know the timeline? >> i would like to know what

steps the fda seized that it is going to require in order to move forward. so you said you expect to see draft guidance on that by december. so then what happens? if you can just outline the steps. >> the draft guidance is out for public comment for anywhere between 60 and 90 days and we look forward to all the comments in the scientific community to help shape and modify that guidance in the hopes of making a final, so it becomes sort of like the guideline to an approval package. now, the timing and the ability to get get a device approved depends upon a lot of people. it really depends upon fda being transparent and setting this guidance out there so that industry can follow this and actually conduct the studies. that takes time and it takes people like you out here in the blue shirts to volunteer and any

part of these studies. so the process is that i probably made to next year it will be finalized and even when it is not finalized, but when it is published in december, industry can start developing their process and getting to an outpatient study and a pivotal bold study that will lead to an approval. in november of 2010 i believe, one of the jdrf investigators that are artificial pancreas workshop estimated anywhere between 2013 and 2014 getting to a pivotal study. there's a lot of information and needs to be built up to get to that final stage for product approval and it is contingent on the research for glucose sensing. when he better sensors. we absolutely need more reliable, continuous glucose monitor sensors and when he do research to really find out how to make that happen. >> dr. rodgers, you talked about

the role that nih has with the fda. can you talk about how nih can be helpful in moving the process forward? >> well senator, in addition to working on a collaborative and coordinating basis, some of the vital research that dr. zimliki is mentioning is something that we see as our major contribution in moving the process forward. and making it a reliable and practical step. just recently, as i mentioned, for example and they closed loop system not only using insulin but to try to more closely replicate what the pancreas does and scientists who we funded used to hormones, both insulin and a counter regulatory hormone look at gone to see whether one could be more precise blip -- let glucose control over time

but again these are done sort of in a clinical setting, ultimately for this to be effective in a row the real world. we have to try to replicate and that is why this more recent study is actually looking at two different meal scenarios particularly at night. that would be a critical step and we could use this closed loop system so you don't have to get up in the middle of the night and the parents to check your blood glucose. that would really be an enormous benefit. for example these two scenarios, one lesson ian scenario in which 18 ate a modest medium-sized meal to see how well the closed loop system could look at the various levels of the close control and how that occurred over the setting. another was the sort of a second scenario, and eat out, see you caught on replicate a larger meal that you would have if you would go out dining and how well were you able to maintain that

level of glucose control? these are kind of both barry and basic investigations we were hoping to do but then in addition and bar practical real-life scenario and in moving this research forward in the clinic to the bedside. >> madam chairwoman my time is up but i wonder if he would allow me to just ask mr. kline one question? thank you area much mr. kline for being here and for being willing to testify on what we need to do. if you had one comment that you could leave with policymakers after today's hearing, what would it be? what would you like us to take away from this hearing? >> i love the question you were posing because you are asking in simple language to explain what are the steps because so many things get lost along the way in the byzantine labyrinth hallways

of bureaucracy. i love that you are asking for a timetable and four really simple explanation of when will this happen and what needs to happen in order to get the artificial pancreas for example that we have been talking about, the one that we have described, that will alleviate for these children and for type 1 diabetics around the world the constant burden of self monitoring, something that will effectively work as a pancreas works and doles out the appropriate amounts of insulin and glucagon and takes the worry out of the constant vigilance that type 1 diabetics have to practice. >> thank you all very much. >> thank you. senator pryor. >> thank you very chair and i

would like to start with you if i could dr. zimliki. you know, great news on the artificial pancreas and some of the really positive encouraging things you have said and the other panels have said about it. but another question that i don't think i've heard yet or an answer i have not heard yet is, but would be affordable for the average household? so tell us what your anticipation, what your with your expectation is on cost? >> i wish i could tell you that answer. fda or my role within fda does not focus on the cost. we worry about getting the product approved. i will say that we are in collaboration with cms for reimbursement and the hope is one day not only will this study provide approval for marketing within the u.s. but also for reimbursement. >> and you said there are several models that are out there that may be headed to the

marketplace? >> several types of artificial pancreas systems? yes. >> and you anticipate they will be approximately the same cost or will there be a big cost disparity? >> again i would have to defer to industry who sets these prices so i apologize that i can't answer that. >> part of your process though you don't fully look at the cost? >> part of my ross as i look for the safety and effectiveness of the device. >> well we will have to work through the cost may be in another setting the thank you for the answer. dr. rodgers, let me ask you if i may, how does the united states compared to other countries when it comes to diabetes research and treatment? are we leading the world? are we behind? how do we rank out there? >> i believe the research that is conducted in the united states really does -- i think we can be proud in particular nih

sponsored research as well as research that has sponsored public groups and diabetes in particular with making great strides in not only understanding the genetic susceptibility as i mentioned in type 1 diabetes. a few years ago we had three genes analogous up to 50 and they know that among these 50 for example there are a small number of genes that contribute a great, a large amount of the genetic risk and there is a large number of genes that have only a small component. in this country, for the first time and as a direct result of the special statutory funding, we are beginning to see now that diabetes incidence of this disease is increasing and it is increasing at an earlier age. we have to assume over this period of period of time it really isn't genes that are changing but it is actually something in the environment and that is what it is important to

undertake bold studies to determine what the czar and the environment that are contributing to accentuating or initiating that autoimmune attack. this is why this study that i referenced in my comments really is going to provide us with a lot of information. early on they beer using new technologies, for example the human microbiome in which we are looking at the samples that we are collecting from these children over time and it is already giving us information about potential viruses or bacteria or other agents we are exposed to. type ii diabetes although we are not focusing on this, type two diabetes the story is quite similar. just a few years ago we just had a few number of genes and now we are up to 60 or 70. that explains the type ii diabetes. we are understanding a lot more

about type 1 diabetes contributing to prevention and potentially treatment of type ii diabetes as well as contributes to that 174 billion-dollar annual cost that senator collins referenced in her earlier statement. >> the united states, as we do research we are sharing that with the world and others are benefiting from that research as well. >> yes. certainly our investigators work that is performed and funded through the nih is being publicly available so that others can potentially mined the data and ask other promising questions. this is how one can really leverage the investments to get the greatest return on one's investment. >> and haven't we designated a certain amount of funding or a percentage of funding to nih specifically for diabetes research? >> well obviously the special statutory funding is exclusively

for that but over and above that, regularly appropriated funds also go to diabetes research. >> and you can see the results of that statutory funding? >> oh, absolutely. i listed just a few highlights to give you just a glimpse of that but over it period of time in which this funding has occurred, we have really made major steps by leaps and bounds both in terms of our understanding but moving forward eventually at all steps in the progression of the disease. >> the number of cases of diabetes has gone up in this country. are you saying that all around the world? >> the number of cases that have been followed largely, the highest prevalence are in scandinavian countries. finland for example has the highest incidence rate of the disease. the lowest incidence by comparison is venezuela and there are a number of -- so this clearly may be related to racial ethnic differences, perhaps

exposure and the environment to factors and diet. maybe sunlight exposure are other things but for the first time as a direct result of the special statutory funding, we have developed a program in collaboration with the cdc to begin to search for the incidence and certain places around the country to begin to determine whether our incidence rate is static or whether it is increasing. we are beginning to see the same thing that is occurring over in the scandinavian countries that not only over time is the incidence increasing but it is occurring at a much earlier age. >> one last thing if i may add a chair on. you are seeing that same disparity geographically in this country? i think in my state we have a few counties where the incidence rate is over 10% and not true in other counties. it is a more concentrated in the southeast part of of the united states? >> i'm not aware of any

predilection and the united states although i would say the search and study with in conjunction with the cda is looking at particular clusters where they may exist. when one sees clustering of the best that has a high possibility or opens a possibility that there might be all environmental factors and that is something we are now poised to be able to look at as the cdc does for other types of clusters of disease. >> thank you. thank you very chair. >> thank you very much senator pryor. senator begich, welcome. >> thank you very much madam chair one. i know you have a bill on the floor. i know senator lieberman, you are playing tag teams so thank you very much. i want too a statement and then i want to ask a couple questions if i could to dr. zimliki. first first i'm pleased to be am pleased to get the update on the current research and hear from

so many folks and also from these young people. i have to tell you, you have been very patient or all of our presentations and discussions. for young people here, we could take a lot of lessons from them so thank you very much. [laughter] mr. pryor just whispered, if only the senate could do that. i agree with him. we have come truly a long way in managing type 1 on a day-to-day basis. is a matter of fact spent some time with two alaskans, part of the children's congressional delegates somewhere whenever there. we actually went and watched the nationals, the mariners and we are seattle fans. we felt we were winning until the bottom of the ninth and depending -- if anyone watch that game, if you want to see a baseball game that is the one that was well worth it so we had -- they are nodding their heads yes. but we also had a chance to talk reef and we will talk later

today but i i know their attendance and their parents, karen and steve, can we want to thank all the families that are here in the children that are here to help us understand better. but it's exciting, particularly exciting to see the development of the artificial pancreas and i can truly transform lives. i understand that we must continue to invest in the tools and help better manage the disease but i also know we all are really in want and need of investment of research to help find a cure. to this and we must continue to force public partnerships to find a cure. diabetes is common and growing in the state that i represent, alaska. in 2009 nearly 7% of alaska's population has been diagnosed with diabetes. in 2007 the direct and indirect cause -- costs were state was approximately 419 million. we can talk about the caw systems up when you look the other impact, the human impact,

the families and the burden of the disease and what families have to do it is significant. this is why and very glad to have so many people here today to deliver the impactful and memorable message. two years ago when i first got here an alaskan team came to visit to me me to advocate on behalf of the special diabetes program. she brought me a photo book of her life and what she has been doing to deal with type 1. and it was very amazing because you can talk about it but when you see the photos and her life unfold from day one as she went through it, it was pretty impactful and a booklet i still keep in my office to remind me of the impact in stories all around this issue. again i want to think of the parents and the kids that are here. thank you for your advocacy. doctor of i can ask a couple of? questions. i want to swell up on senator pryor real quick. you mentioned cms reimbursement. you said you are working through

that and no disrespect but always on a federal folks in frenemy it is always soon, maybe we are working on it and i'm going to ask a very specific, what you think the timetable is for cms to actually respond and resolve the issue of how it is going to be paid for? >> i can speak on behalf of cms but i will tell you the following, is that the first priority is to develop the appropriate clinical studies necessary for product approval and archiving within the u.s.. we are hopeful that we can -- we affiliates and they would like to make sure the clinical study proposed can actually kill two birds with one stone don't so to speak so we cannot only have the clinical data necessary for product approval but also reimbursement and we are hopeful that we can work with them. we have also communicated. >> let me pause you there for a second. when you think you will have that? when do you think that will get

some results to say we have partners and we are ready to roll? >> i think we need to finalize the draft guidance first. >> so from december to win them? i hate to do this. i do this to every committee. you are not alone. and a christie, they have these common phrases and i recognize it as a former mayor who administrators and local city council. we use the same phrases so i know that. what i'm saying is after december you are working through this now, but give me a sense. >> i apologize for interrupting but in developing and publishing this guidance it is not a trivial task. this is a huge monumental effort that the agency is putting forward and i would like to say that we would have that information available at the same time as the publication of guidance but i simply cannot guarantee that data and i apologize for that.

>> based on your experience for something of this magnitude, is it for cms to say yes we can do this? it will be two years, three years? >> i don't have the experience or the luxury of knowing how long that would take. i will talk to my commissioner. >> and then maybe you can, on issues of this magnitude maybe you can give me whoever would be the person at the fda experiences of the past and how long it's at. if the think that would be important. the last thing i i will ask very quickly and i apologize, have to depart. how many do you think clinical locations do you anticipate for the trial? do you have a sense of that get? >> it really depends upon how quickly industry wants to do it and how much variability they want to introduce in their clinical study design. certainly it is more than one. but it really is dependent. we have introduced enough

flexibility to allow industry to sort of dictate how many sites they need to study and where they would like to study. >> thank you very much and i appreciate the comments and i look forward to what you can do. >> thank you very much. i want to thank this panel of witnesses for excellent and highly encouraging testimony this morning. we will continue to work closely with all of you. thank you. [applause] [applause] our next panel of witnesses consists of children who know first-hand the burdens of living with diabetes. our witnesses are caroline jacobs from maine, jack schmittlein from connecticut,

and kerry carry morgan from virginia and jonathan platt of california. each of these children are jdrf children's congress delegates and we are very very happy to have them here today. [inaudible conversations] caroline, since you are from my home state, you get to go first. [laughter] >> okay. good afternoon chairwoman collins and members of the committee, thank you for asking me to testify before you today. my name is caroline jacobs. i am 14 years old.

i'm from the great state of maine where we stayed maine is the way life should be. i am here as a children's congress delegate to talk about living with diabetes. the importance of technology for me and other kids, with diabetes and my cure. i was diagnosed with diabetes when i was 10 years old. a change my life forever. with this disease i must always think and be aware of how i am feeling. and i've had to grow up fast. i feel the burden on my friends and my family who are always worried about me, always asking me questions about my blood sugar. so i'm getting but i can to make a difference in finding a cure for children of diabetes. i brought a school walk to the cure firm my family swat team for a cure in portland. i also make jewelry and bags to benefit jdrf. i do all of these things so we can continue research to find a

cure for diabetes. while we wait for a cure, hope to see that more tech allergies are made available for kids like me. one of the delegates here is from canada and has the kind of insulin pump continuous glucose monitoring system that protects against episodes of hypoglycemia when the patient is ignoring the dropping sugar levels. with this ability to stop insulin delivery, and detect low blood sugar this pump could lighten the burden and the worry for me and those around me. this technology is approved in canada and in other countries but not here in the united states. it is hard for me to understand how a device like that can't be available in a place just over the border from me. because i will be driving in the next two years, it would be important for me to have access to technology that could help

prevent my blood sugar from dropping. having diabetes can make your blood glucose levels go too high or too low and make me feel sleepy or dizzy, confused or have word fish and making it too dangerous to drive. i would invite congress to encourage the fda to move forward on next that's relating to the artificial pancreas, combination of continuous glucose monitoring and an insulin pump the software that communicates between the two. the device will prevent highs and lows especially at night when those can be most dangerous but it will also keep control of my sugars while i'm driving as well. i hope we will not have to wait too long for this device. that way, but no longer have to worry about others worrying about me. more importantly, my family will feel less of a burden at my friends won't always have to adjust around me because of this disease. and i hope this means that i will have the opportunity to

travel freely without wearing about this disease and enjoy the world and those -- after all isn't that the way life should be? thank you members of the committee, especially my home state senator, senator collins. >> thank you. [applause] that was terrific. you sound like a pro. that was great. jack, we are glad to hear from you next. >> thank you senator collins, senator lieberman and members of the committee for inviting me to testify. my name is jack schmittlein. i'm 13 years all and i've had juvenile diabetes for over six my .. changed forever with my diagnosis. instead of being a carefree kindergartner, i was faced with sticking my fingers eight to 10

times a day, counting cards in taking insulin shots. managing diabetes is hard work, 24 hours a day every day. .. passed legislation to remove the special diabetes program essential to help finding a cur >> this special diabetes program has lots of research leading to the artificial pan crease to

help my blood sugar from dropping. right now, i have to get up, take my blood sugar in the middle of the night every night. it makes participating in activities a love a lot easier. i enjoy playing basketball and football, but i have to come out in the middle of the game to test my blog sugar. it would give me life to feel like a kid again. it's great, this technology, we have to do everything we can to find a cure. i'm doing my part and i've been a captain for four years, organized a walk at my school to benefit, and spoke p about life of diabetes in two walks, and a fundraiser. it is my hope that congress will continue to support research at nih to specifically the diabetes program and believe we'll find a cure for type i diabetes.

the artificial pancreas is a promising look. i look forward to say i used to have diabetes, until that day, an artificial pancreas will help as long as others who have type i diabetes. just think, if we can improve the lives of million of children, why wouldn't we? research being conducted all over the country is bringing us closer to a cure and the development of the artificial pap cree yays -- pancreas can keep us healthy while we wait. thank you for letting me give you into a look of my life and look forward to any questions you may have. >> thank you. [applause] thank you, jack, you did a great

job. carrie, you are next. >> good afternoon, thank you for inviting me to testify today. i'm carrie margan, and i was zigged years ago at 4 years old. my older sister was diagnosed to. i was in a clinical trial with people who are type i to see if they were at risk for developing the disease. i received daily insulin injections to delay development of diabetes, but it didn't work. sometimes clinical trials don't. i was diagnosed one year later. then, in what seems like a flash, ten years passed. ten years of finger sticks, tubing changes, and countings and worry. ten years of turning around an

awful green fapny pack. even with my best effort, i still have days of high and low blood sugars. we hope like the millions of people impacted by this disease too for a better way to control this. i was 14 when i enrolled in a trial. this ingenious device gave me knowledge of what my blood was doing and going. on this trial, by a1c dropped from an 8 to a 7. this made living with the disease easier, but gave me hope it was possible to manage diabetes better. it was not a cure, but it was more than i had before. living with diabetes is a daily struggle. it creates this cause of fear and doubt. blood sugars and carbs are always on my mind, have to

remember snacks and supplies in case of accident, i'm covered. i had my pump stop working out of town prompted by dropping it. i just don't worry about now, but my future. diabetes never takes a break and nor can i or my family. i enrolled in a trial testing pancreas technology. for two days, i was in a hospital testing the closed artificial pancreas system. after participating in clinical research since 3 years old, i can tell you this trial was the most amazing experience of my life and holds so much promise for people living with disease. i had perfect control of my blood sugar levels and two days of this technology gave me the vision of what life could be like. life with far less complications. creation of an artificial pancreas is within reach. i know it. i've been a part of it, and i'll

do all i can to get it in the hands of people living with diabetes, and i hope you will too. on the day that artificial pancreas is approved and released, people with the disease can say, diabetes, there's an app for that. [laughter] [applause] >> thank you, members of the committee for those of you working with diabetes and making this technology available for all of us living with this disease. >> thank you very much, kerry, for a great testimony. [applause] >> john, you're up. >> good evening, chairman and other members of the committee. thank you for inviting me to testify. i'm john plat, from california,

live in las ang las and 7 years old. i was diagnosed at age 6. i have been losing weight, wetting the bed at night, and have extreme thirst. i was always very tired and emotional. my mom and dad thought i was adjusting to a new school. my blood sugar was 650 when i was diagnosed with juvenile diabetes. i'll never forget the day i was diagnosed. we found out through the doctor who was in the elevator with us who had diabetics also. that neverred happened before, two kids diagnosed at the same time. i was thinking how did i get this disease? i didn't know what it was. i was very scared and nervous. i'm here as a delegate to tell you i manage my disease, but i do not let it control my life.

well, this disease i'm able to swim, play basketball, and build legos, but i'm different. unlike other kids, i have to check my blood sugar eight to ten times a day. everything i eat is measured and every carbohydrate counted. my blood sugar is with me everywhere i go. it's hard when i go to summer camp or to a sleepover or even go to a friend's house. too much exercise or not eating all my food can be very dangerous. i think i'm too young to talk about and worry about all this stuff. my parents had to adjust their life because of my diabetes. we all have it, not just me. managing diabetes is the 24-hour job. we are doing our part to help find a cure by raising money for

the walk. i'm here to ask you to continue to do your part and finally search to find a cure, a cure for diabetes means that i could go to any summer camp, have sleepovers whenever and wherever i want, and be a regular kid again and most of all, it would mean i would not have diabetes. please help me make this possible. my life depends on it. thank you. [applause] >> you did a great job. [applause] [applause] >> john, you did a wonderful job. >> i think this entire panel deserves another round of applause.

[applause] >> now, i know the children here have been sitting a very long time and that many of them could use a snack or water or need to test themselves or so i'm going to ask the panel to each just ask one question, and then we'll just wrap up the hearing because i know it's been a long afternoon, particularly for some of the younger delegates who are here. fist of all, thank you all for just wonderful testimony. you really have put a human face on what it's like to have diabetes, and that is far more powerful than statistics or than our being advocates for more

funding. you're the best advocatings we could possibly have. caroline, me question is for you. you were diagnosed in the summer, and you had some time with your family to get used to the idea of having diabetes and to learn what you needed to do in order to manage your disease, and i'd like you to share with us what it was like when you went back to school in the fall. >> well, i had -- we had to -- i was going to a new school at the time, so i was teaching my teachers how to deal with having a kid with diabetes and teaching my new friends how to carb count and all that stuff. at lunch, we would like try to figure out how many carbs my food was together so it was like we had a lot of support from

friends and teachers and my family, of course. >> i'm sure that made a real difference. >> i just wanted to refer to the scrapbook, you gave me yours, and it's wonderful to go through it because i've learned so much more about the disease and about you, and i want to thank you you especially for being here and all of our delegates. >> thank you very much. >> senator brown. >> thanks, madam chair for colding this and looking out there, i think it's the academy awards. there's kevin kline there, and i come back to the reality, and we're discussing something very serious that obviously affects everybody in the room, and each day, wonderful part of being a united states senator is each day you can learn and grow and understand new and different things, and if you don't understand, you have an opportunity to find out the answers which i find

intellectually very, very stimmew late -- stimulating. john, i agree with you. you're too late to have to -- too little to have to worry about this stuff. that being said, what has the biggest challenge been for you since you recently found out? what is the most difficult part of everything you're going through right now? >> well, -- >> is it, keeping the daily requirements, is it worrying about, you know what happens if you don't do it right? what's the biggest challenge do you think? >> let me -- you think about it a minute. i'll ask jack. >> probably my biggest challenge with diabetes is like, well, at school when all of our friends

like go to lunch, i have to always go to the nurse and go through my lunch and stuff and if we're in class and it's fun, my blood sugar is too low or too high and have to go to the nurse. i miss out on the fun. that's hard for me because it's not fun to miss out on things you want to do with your friends. that's win of the things that's challenging for me. >> when you said 650, was it? you said that the average is 100 or below. that's amazing that you are able to really function and still now obviously address it. have you thought of something challenging yet for you? >> yes. every time i feel alone, there's no nurse at the school, and if i feel low, i have to go back to class and i have to check my blood sugar with the teachers. >> so you miss out on some things. >> yeah.

>> thank you for that. thank you, panelists. >> thank you very much senator brown. >> thank you, thank you all very much, and you're great advocates to do more. kerry, my question is for you because you have not answered a question. we have doctors here, and there's been a lot of discussion today about the artificial pancreas. since you participated in one of the trials, is there anything you'd like to tell them about that trial that you hope they bear in mind as they go back to nih and the fda and continue work on trying to get an artificial pancreas that can be available to people? >> first i'll say it's awesome. keep that in mind, and being on an artificial pan pancreas was different than just living with

diabetes. at that time, i didn't have to worry. i didn't have to think about it, and that was the new experience for me because i had this since i was so young, i don't know anything else so not having to do that was a weight off of my shoulders, and i think everyone here could use that, and so bear in mind that i think we need it, and we need it soon so keep working, keep funding, keep researching, and hopefully it will be out soon. >> thank you very much. [applause] >> thank you, madam chair for holing the hearing and your work of chairing the diabetes caucus as we can see it's really making a difference. >> kerry, i really think your final words sum up why we're here and what our purpose is, but i do want to take this

opportunity to thank everyone for coming to this hearing. the wonderful witnesses that we had, the delegates who were chosen to testify, all the delegates who are sitting in the well and around the room, and their families because diabetes truly is a disease that affects the entire family. i want to thank the juvenile diabetes research foundation for working so closely with us. mary tyler moore sent a letter and testimony that we're going to put it into the record, and we'll have the record open for an additional 15 days in case anyone else has any words of wisdom for us or additional questions, but most of all, i want to thank the children who are here today. when you come to washington, and you meet with your senators and

members of congress, you make such a difference. it's because you're willing to come here and tell your personal stories that we've been successful in tripling the funding for research that goes for diabetes, and i know that with your help, we will one day soon, have better treatments, the artificial pancreas that we talked about today, but also ultimately the goal of all of us here and that is a cure, so i thank you all for coming to washington for being here with us and for being such great advocates. this hearing is now adjourned. [applause]

[applause] [inaudible conversations] [inaudible conversations] >> today no legislative business in the senate, but members talked on general topics including the federal budget. next, senator mike lee, republican of utah, addresses raising the debt ceiling. this is 10 minutes. >> mr. president, i stand to talk about a looming crisis in this country of problems that has the potential to effect every american from every state, from every political party, from every political ideology. that issue relates to our national debt. we've accumulated nearly $15 trillion in debt through the federal government which is a lot of money, split up among 300 million americans, works out close to $50,000 a head.

a lot of people don't make that much money in a year, and yet that's what every man, woman, and child owns on a per capita basis the moment they are born. now, if it's calculated out on the basis of debt per taxpayer, the debt is larger depending on how you calculate it and the numbers you figure. we're now approaching the august 2nddeadline given to us by secretary geithner identified as the time by which we must increase our national debt yet again. a debt that has been raised time and time again resulting in our accumulation of about $10 trillion of new debt in roughly the last decade. this is a problem, and it's a problem that's only going to become more severe the longer we kick the can down the road

without doing thinking about it, the way they bring money in and the way washington spends money. i want to talk more for a minute how washington brings money in. there are those who suggested in this town very recently that what we need right now is a tax increase in order to address the debt crisis. i could not disagree more, and i need to state what the greatest emphasis i'm able to place on this issue that a tax increase is something i would impose and devote every ops of energy in me to opposing, and the reason is we have in washington something that is not a revenue problem. what we have is a spending problem. the spending is the crisis we need to address, but on a more fundmental level. we have to remember what we do when we raise taxes. when we raise taxes, we chill

investment. it's investment that we rely on for the creation of jobs because we have to remember the government doesn't have the power to create jobs because it can't create wealth. it can create poll -- policies, and it can adopt laws and regulations in order to promote or detour certain kinds of behavior. it can't create wealth. it can just set in place certain circumstances that might allow wealth to be created or in other circumstances, might detour new wealth from being created. you have true wealth creation leading to true job creation, you have to have a circumstance in which willing up vesters -- investors with capital willing to invest have the reasonable assurance and promise if they place their money and any gains from that behavior will be to their benefit and not taken by a

third party or by the government. when we raise taxes, in effect what we're doing is detouring investment, detouring up vestment at a time when we hemorrhage jobs, and we can want afford to lose one more. not one more job should be lost as a result of what the government does. we have to get the government out of the way so job ration can occur, but it can't when we punish the investor, when we say up vest at your own risk. for that reason, mr. president, i continue to emphasize the fact that i will oppose any attempt to limit this debt limit crisis by raising taxes, and i'll continue to impose any effort to raise taxes. spending is the problem.

now, as to the question of how washington spends money, and if the practice of insanity is the practice of doing something again and again intending or expecting to achieve different results than the results we've achieved every time in the past, them we are insane if we approached this the same way we approaches malfunctioning unproductsive strategies employed in the past, strategies that focus exclusively on immediate cuts or even long-term cuts. let me explain what i mean. as we approach the debt limit discussion, there are those who want to focus a lot of the attention on long term spending cuts. in other words, they might say if we're going to raise the debt limit by a trillion dollars, then we need to find a trillion

dollars in cuts to be made. it it's $2 trillion, we need to find $2 trillion to cut, but, of course, we can't cut a trillion dollars out of the budget immediately. that's not possible. we can't do that in one year. it would have to be stretched over a period of many years. most likely, in this scenario as discussed, it would be stretched over a period of a decade or more. now, we do have the power to control what we do in this congress, but we can't bind the congress that will take power in january 2013 or 2015 or 2017. every two years there's a new congress in place, and that congress has the power to make those decisions that will best fit what they decide is in order at that time. we can't bind them permanently.

any promise we make to cut $2 trillion relies on the promise that that will be honored by future congresses. we can't bind them to do that. there is one way, however, that we can bind them, and that is by amending the 28th time that 224-year-old document that fostered the document the greatest civilization the world has ever known. to amend the u.s. constitution, that's the one credible binding way in this one group of americans can bind a future group of americans. that's why i said the only circumstance in which i think it's appropriate for us to raise the debt limit is a circumstance in which congress has first passed a balanced budget amendment out of congress by the requisite two-thirds mar gyp in this body and house of representatives and submit it to the state for radification.

if that scenario only can we proceed with confidence that the comiments we make now to the american people to make not just immediate cuts, but long-term changes on the way we spend money, only in that se scenario that those promises can be and will be honored. only in that scenario that we can bind a future congress. i pledge to vote against and impose in way i can any debt limit increase that involves something short of prior passage of a balanced budget amendment in addition to any caps, any immediate cuts that may be made. we have to have cults. we -- we have to have cuts. we have to have some spending caps, and we've got to have a constitutional amendment requiring that and requiring that revenues and house match each other from year to year.

if we don't have this, we're at great risk for the practice of perpetual deficit spending in which congress year in and year out spends more than it takes in. now, congress can sustain this for a period of time, but as now is the case, the amount of money congress spends is in excess after $1.5 trillion a year, more than it brings in. we've reached a certain point of unstainability, a point at which if we continue with this practice, we get to the point where a halt in borrowing is much more draconian than anything that could be within our control. at some point, those who would be willing to loan us that money, would be willing to buy u.s. trash ri instruments of one form or another to fortunes the debt whether eventually start demanding a higher and higher yield which means that instead

of spending $50 billion a -- $250 a billion a year on interest that we are paying, the time could come we have to pay something closer to $700 billion a year just to pay the interest on our national debt. in fact, if we were now required to pay interest rates on our treasury instruments that are consistent with the 40-year average, we would be about there. now $700 billion is a lot of money, $700 billion in a year is what we spend on social security. it's roughly what we spend on medicare and medicaid combined in a year. it's roughly what we spend in national defense in an entire year. if we have to spend that amount of money every year as we could easily have to spend within just a few years time if we continue spending at this rate, that's going to crowd o