HOUSE COMMITTEE ON APPROPRIATIONS, SUBCOMMITTEE ON LABOR, HEALTH AND HUMAN SERVICES, EDUCATION, AND RELATED AGENCIES HOLDS A HEARING ON NATIONAL INSTITUTES OF HEALTH: BUDGET, IMPLEMENTATION OF RECOVERY ACT, AND NATIONAL CHILDREN'S STUDY
MARCH 26, 2009
SPEAKERS: REP. DAVID R. OBEY, D-WIS. CHAIRMAN REP. NITA M. LOWEY, D-N.Y. REP. ROSA DELAURO, D-CONN. REP. JESSE L. JACKSON JR., D-ILL. REP. PATRICK J. KENNEDY, D-R.I. REP. LUCILLE ROYBAL-ALLARD, D-CALIF. REP. BARBARA LEE, D-CALIF. REP. MICHAEL M. HONDA, D-CALIF. REP. BETTY MCCOLLUM, D-MINN. REP. TIM RYAN, D-OHIO REP. JAMES P. MORAN, D-VA.
REP. TODD TIAHRT, R-KAN. RANKING MEMBER REP. DENNY REHBERG, R-MONT. REP. RODNEY ALEXANDER, R-LA. REP. JO BONNER, R-ALA. REP. TOM COLE, R-OKLA. REP. JERRY LEWIS, R-CALIF. EX OFFICIO
WITNESSES: RAYNARD KINGTON, ACTING DIRECTOR, NIH
DR. ANTHONY FAUCI, DIRECTOR OF THE NATIONAL INSTITUTE ON ALLERGY AND INFECTIOUS DISEASES
DR. DUANE ALEXANDER, DIRECTOR OF THE EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT DR.
JOSEPHINE BRIGGS, DIRECTOR OF THE NATIONAL CENTER OF COMPLEMENTARY AND ALTERNATIVE MEDICINE
DR. PATRICIA GRADY, DIRECTOR OF THE NATIONAL INSTITUTE OF NURSING RESEARCH
DR. STORY LANDIS, DIRECTOR OF THE NATIONAL INSTITUTE OF NEUROLOGIC DISEASES AND STROKE
DR. JOHN NIEDERHUBER, DIRECTOR OF THE NATIONAL CANCER INSTITUTE
DR. GRIFF RODGERS, DIRECTOR OF THE NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
DR. JOHN RUFFIN, DIRECTOR OF THE NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES
DR. LAWRENCE TABAK, ACTING NIH PRINCIPLE DEPUTY DIRECTOR AND DIRECTOR OF THE NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
[*] JACKSON: I'd like to welcome Dr. Kington, and the Institute and Center directors who are seated behind him. At today's hearing, we would like to discuss NIH's implementation of the Recovery Act funding NIH received, the president's fiscal year 2010 budget for NIH to the extent that is has been made public and the status of the Longitudinal National Children's Study, which many of our subcommittee members are interested in, but which has never received much discussion because President Bush tried his hardest to eliminate it.
Between the omnibus spending bill and the Recovery Act, we were able to provide an $11.3 billion increase for NIH, the largest ever one-year funding increase to NIH. I'm sure, Dr. Kington, that were Dr. Zurhuney (ph) here today he would love to be in your seat these days.
With that kind of increase the committee will be watching carefully to be sure that NIH spends it in a way that both stimulates good science, to propel our economy and to create high-paying jobs throughout the country.
We appreciate having some of the NIH Institute directors in the front row today. Dr. Kington, you should feel free to have them respond to specific questions, if you'd like. There's an empty seat to your right, to my left with a mic for that purpose. Mr. Tiahrt, are there any comments that you would like to make?
TIAHRT: Thank you, Mr. Chairman. I'd like to welcome Dr. Kington as well; and the National Institute of Health, Center directors who are here. Thank you all for coming.
Mr. Chairman, I'm particularly glad you scheduled this hearing, given the NIH currently has 33 percent more resources than it did last year. I'm interested to know how it's going to be spent. While I would like to discuss the upcoming budget it appears that our friends in the executive branch may themselves not yet know what it contains. That is unfortunate because I know that the Chairman and I both would like to get started in earnest so we can avoid the end of year crunch that leads to an omnibus bill.
I'm also pleased that we are going to be discussing the National Children's Study and some of the problems it has encountered over the last couple years -- problems that in my view should never have happened and have jeopardized the entire study.
At any rate, I look forward to the testimony and I yield back.
JACKSON: Thank you, Mr. Tiahrt. Dr. Kington, we have your written statement. Please feel free to summarize with oral remarks. You'll have adequate time to answer any questions. We welcome you to the committee and congratulate you for your ascendancy in this acting role.
KINGTON: Thank you, Congressman Jackson, and good morning to you and other distinguished members of the subcommittee. It's an honor and a privilege to appear before you today to discuss the National Institutes of Health implementation of the American Recovery and Reinvestment Act.
Before I begin, I'd like to introduce my NIH colleagues who have joined me -- Dr. Anthony Fauci, Director of the National Institute on Allergy and Infectious Diseases; Dr. Duane Alexander, Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development; Dr. Josephine Briggs, who will soon be here, who is director -- who's here -- who's Director of the National Center of Complementary and Alternative Medicine; Dr. Patricia Grady, Director of the National Institute of Nursing Research; Dr. Story Landis, Director of the National Institute of Neurologic Diseases and Stroke; Dr. John Niederhuber, Director of the National Cancer Institute; Dr. Griff Rodgers, Director of the National Institute of Diabetes and Digestive and Kidney Diseases; Dr. John Ruffin, Director of the National Center on Minority Health and Health Disparities; and Dr. Lawrence Tabak, Acting NIH Principle Deputy Director and Director of the National Institute of Dental and Craniofacial Research.
First, I want to express my sincere gratitude on behalf of the Agency for your support of NIH in fiscal year '09 budget and for the continued trust you place in NIH to make the discoveries that will lead to better health for everyone as reflected in the recent appropriation of the $10.4 billion in ARA and the 3.2 percent increase in fiscal '09 Appropriations Act.
I thank you on behalf of the many scientists we are able to support at more than 3,000 research institutions throughout the 50 states and U.S. territories; and on behalf of the public who count on our research to help detect, treat, and prevent hundreds of diseases and conditions. As you noted, I submitted my testimony for the record, and I will try to just highlight key points for you this morning.
As we are all painfully aware every sector of America is facing challenging times from the drastic downturn in the economy. The biomedical research community has not been spared from this turn of events. It's an unfortunate irony, however, that it comes at the same time that we are seeing extraordinary scientific opportunities for improving health.
This is worrisome not only because it means fewer jobs, but also because innovation and a constant influx of new talent are crucial to the nation's economic success and to a robust biomedical research enterprise. So it's timely that the president and Congress provided ARA funds to NIH to stimulate the economy and to advance biomedical and behavioral research.
To bring the impact of ARA down to the individual level, I'd like to share with you the following. One of our program directors received an e-mail several days ago in response to news that an applicant's grant application is being considered for funding with ARA money.
Here's an excerpt from the email -- 'We gave a termination letter last Friday to my long time post doc. His job has been saved. He's going to be thrilled to hear about his change in fortune. I would also like to hire a technician with new funds since I presently don't have one. I am certain that similar scenarios will occur throughout the country over the next few years as we implement the Act. Your decision sends a strong signal to scientists in the field and to bright, young people who may be one day choosing science as a career that the United States is willing to support outstanding research and outstanding scientists.'
Here is only a sampling of the important work that we will support with ARA funds. For example, we will expand rapidly our understanding of a wide range of disease and conditions including diabetes, forms of cancer, addiction, glaucoma, heart and lung disease, arthritis, kidney disease, and mental disorders. In addition we will expand our efforts in community-based research with a special focus on minority and underserved populations and make further investments in the potential applications of nanotechnology.
Just to briefly review, the ARA provided NIH funding in the following ways. It appropriated $8.2 billion to NIH for scientific research. It allocated $1.3 billion for construction and equipment at our grantee institutions, $1 billion of that focused on extramural construction and renovation, $300 million to share implementation in large capital research equipment. The remaining $500 million will be used to fund high priority repairs, improvements and construction on the NIH campus to enable the highest quality of research to be conducted. In addition, $400 million was transferred to NIH from the Agency for Healthcare Quality and Research to support research in comparative effectiveness.
Let me review how NIH will be using the dollars in direct support of science. NIH is using a nimble approach to investing the money quickly with the greatest impact. For example, we are in the process of determining which of the highly meritorious applications that we were not able to fund last year would make sense scientifically to fund for the next two years with ARA dollars.
NIH has already issued a number of new funding announcements. In particular, we've made targeted grant announcements to stimulate research in high priority areas. An excellent example is our announcement this week of four research grant announcements related to autism, a disease that affects so many families in America.
NIH has committed $60 million of research funding to address the differences across the autism spectrum of disorders. Researchers will help develop and test diagnostic screening tools, assess risk from exposures and to test early interventions and adapt existing pediatric interventions for this population.
NIH has created a number of new programs that will spur new areas of research and trigger an almost immediate influx of research dollars into communities across the country. For example, we've introduced the Challenge Grants Program, the Grand Opportunity Program or GO Grants, signature initiatives and a program to encourage the recruitment of new faculty to conduct research. And finally, a summer program that hires students and science teachers in research laboratories. And I'll speak a little bit more about a number of these programs next.
For the Challenge Grants, we issued the largest RFA in the history of NIH. This is a shortened version of it. A 220-page document that lists 237 scientific topics in 15 broad scientific areas. We expect to devote at least $200 million to this effort.
The research funded under the Challenge Grants Program will fund a number of important new topics including advances in biosensors, new approaches to HIV therapy, new research in bioethics, research on health disparities in clinical research, pain management and the new area of so-called 'theranostics' -- a combination of the word 'therapy' and 'diagnostics' -- which refers to materials that can both diagnose a condition and treat a condition. So a material that might be painted on a tooth that could both detect a fracture and repair it.
Another new program is the Grand Opportunity Program or the GO Grants. This program will highlight large-scale research projects that accelerate critical breakthroughs early in applied research and cutting-edge technologies, and new approaches to improve interactions among multidisciplinary and interdisciplinary research teams.
NIH is supporting a number of important signature initiatives that will support exceptionally creative and innovative projects in programs to address major challenges in biomedical research. The initiatives will cover new scientific opportunities in nanotechnology, for example, genome-wide association studies, Alzheimer's disease, oral fluids as biomarkers and community-based research, just to name a few of the potential topics.
We've also announced an important new program to support newly trained faculty to conduct research. This will help address the need to support early career scientists who are one of NIH's top properties. Funding will be provided to hire and provide appropriate start-up packages and to develop pilot research projects for newly independent investigators.
We are also particularly delighted to tell you about our expanded summer program for teachers and students across America. Funds will support short-term summer jobs for high school and undergraduate students as well as elementary, middle, high school, and community college science educators in laboratories across the country and will provide several thousand young people with an opportunity to experience the world of research. We hope this experience will spark their desire to become scientists.
We are mindful that a top priority for the use of ARA funds by NIH is to create and preserve jobs as well as increasing purchasing power in all corners of the country. We firmly believe that we can do this while carrying out the core NIH mission and without compromising our commitment to fund the best scientific research ideas. We will fulfill ARA's comprehensive reporting requirements including jobs creation and preserved tracking of all projects and activities and trend analysis.
To track all of NIH ARA related activities I invite you to go to our website, www.NIH.gov, which we will update regularly.
In summary, groundbreaking discoveries are most often built on the foundation of many incremental advances that bring us closer to diagnosis, treatments, and other public health improvements expected by Congress and the American people. Because of ARA funds, there will be more discoveries across the country next year and many years to come. These findings will yield better understanding of the major diseases and disorders including those that I touched upon here today and hundreds more as well as providing keys to allow all of us to live healthier lives.
As I said in my opening comments, we are grateful for your commitment to biomedical research and all the promise that it brings to people here in the United States and around the world. We have employed a number of innovative strategies to quickly and wisely invest ARA funds. We will stimulate the economy. We will create jobs and we will advance science. And most importantly, ARA will help us contribute to our principle mission, which is to make scientific discoveries that will improve the public's health.
I'd be pleased to answer any questions and I will take advantage of the opportunity to call upon my colleagues for special response to particular topics in their areas of domain. Thank you again.
JACKSON: Dr. Kington, thank you very much for your testimony. We're going to try today to adhere as closely as possible to the five minute rule. I'm going to certainly apply to myself. And I want to thank my colleagues for coming to today's hearing. Chairman Obey who would normally be chairing the committee has found himself in another conflicting scheduling event and expresses his deep regrets for not being here to all of the Institute directors, Center directors and to you.
The recovery bill provided about $1.5 billion for extramural research facilities at NIH campus research facilities where the money is awarded for new construction or renovation it is sure to generate needed jobs across the country. What is your estimate of jobs created through this funding? How critical is it to modernize biomedical research facilities in order to achieve the scientific advances of NIH that has been outlined in the road map? And what is the estimated backlog of creating adequate research space? That's my first series of questions.
KINGTON: First of all, we anticipate that the extramural construction support, which is the $1 billion that will go out across the country, will allow us to deal with the extraordinary backlog on academic campuses throughout the country in basic renovation and improvements. I believe the estimate was around $9 billion of backlog across campuses across the country. This $1 billion is a significant down payment on that large amount of resources that are needed to bring these buildings up to speed.
We think it will have a direct impact on the quality of the research that we support and the relatively small amount, the $500 million that will go on campus support to support contract -- excuse me, construction on campus will also allow us to substantially improve the quality of our research buildings and to catch up with the deferred maintenance backlog that we've accumulated.
We have not estimated exact numbers of dollars -- numbers of jobs that will come from the construction dollars, but we can get back to you with estimates. We don't have exact numbers right now. We have better estimates for the jobs that will come from the research dollars.
JACKSON: Can you give us some sense of that?
KINGTON: We estimate that each of our grants on average supports between six and seven jobs either in part or in full and we're in the process of actually doing an even more detailed study to look at the exact numbers that will come from the various mechanisms. That comes from a number of studies that we have conducted by pulling a sample of our grants and looking at their funding patterns.
One of the opportunities with the reporting that will come from this associated with ARA is that we'll probably have better information than we ever have had about the economic impact of the dollars that we support.
JACKSON: Dr. Kington, I want to congratulate NIH for a well- thought-out plan for obligating the unprecedented funding increase for fiscal year 2009. However, I think we all recognize that the Recovery Act funding for NIH is a double-edged sword. It provides unprecedented funding increase for this year and next year temporarily hiking the number of new grants and success rates, but the prosperity is short-lived. After two years of funding, NIH is back to where it started -- low success rates and potentially scant money for new grants. That is unless the administration and Congress acknowledge the hole we've dug for NIH and own up to our responsibility to continue stable funding.
I know you'd have to be a loyal administration to witness, but can you give us a straightforward assessment of what will happen to NIH scientists in 2011 after the Recovery Act money dries up? How many additional scientists will receive research support under the Recovery Act? And how will those scientists be supported once the funding dries up?
KINGTON: First of all, we've had some experience with planning for large influxes in support to our budget having lived through the doubling and then the not so soft landing that came after the doubling. And we've learned from that experience. We're much better at estimating the churn of dollars. And with these dollars, we've made an effort to limit the impact by limiting our commitments to only the two years of the dollars that come with the Recovery Act.
We, however, anticipate that if these dollars actually generate the research advances that we hope they will generate, we will probably have an increase in applications beginning in '11. We've done some estimations and we believe that it may drop the success rate at least several points below what it has been if we don't have a substantial increase in our budget.
We've tried to use these funds wisely so we can minimize the out- year impact, but it is inevitable that if the dollars are used successfully will generate advances which will in turn generate new applications. And we're trying to limit the impact. But in some ways, it's an indication of the success of the funding to generate new scientific advances.
JACKSON: Mr. Tiahrt?
TIAHRT: Thank you, Mr. Chairman. Welcome, Dr. Kington. I don't think there's any question you guys do wonderful research that's dramatically improved the lives of Americans and I want to congratulate you on your persistence. There is some concern on my part about this pig going through the python, if you will -- this $10 billion that's going to be a 33 percent increase to your budget. But it's only for a limited time.
And our chairman, Chairman Jackson here, I think is right to be concerned about how that's going to be spent and I think probably what justifies that concern is the National Children's Study where we started in 2000 to do some good things by tracking 100,000 kids from conception when life begins until the natural progress through life. And I think it's going to reveal some very interesting things.
But it originally started out to be approximately $3.5 billion over a 25-year period. And most of us found that like a good plan. Now I'm hearing that that cost may actually double. Is that about right?
KINGTON: Well, we have every plan to bring the cost down, and I can answer in more detail. But we anticipate that the total cost will not be doubled.
TIAHRT: The reason -- the concern is if we take this $10 billion pig going through the python and find out it's really $20 billion later on, we could shortchange ourselves and our future by having to shut down research or limit it when it could reveal some very profitable things for the life and well-being of Americans.
So I'd like to know a little bit better about how that $3.5 billion was developed and how it expanded. Did we decide we need to include more children in the study or did we have to hire more people to conduct it? Did we -- after ignoring Kansas -- pick up some additional states? Nothing is settled there.
KINGTON: I'm just grateful that we are the python and not the pig. The National Children's Study is a study of unprecedented size and complexity that is designed to answer extraordinarily important questions about the role of environment, and particularly in development of children. This study began out of a working group that identified the scientific need, and then planning was initiated.
Over the last five or six years, we've had a number of opportunities to estimate the cost of the study. We were estimating a moving target because it became clear early on that once we generated a comprehensive wish list of scientific subprojects that we wanted in the study, it became clear that we would not be able to fund all of those research components, which is not unusual for a large research project.
TIAHRT: Are you still going through that analysis? And so you may be able to limit the increase in cost?
KINGTON: Absolutely. In fact, we received advice from the National Research Council at the National Academy of Sciences where we were told -- advised to have a pause after a period of extensive pilot when we could analyze results of the pilot, see what worked, what didn't work, see what the costs were and then make adjustments.
TIAHRT: Is that pilot going at the end of this fiscal year? When will your pilot project be complete?
KINGTON: The pilot project consists of seven vanguard centers -- two are operational now, five more will come online next month. They will have about a year of operation and we really need that period of time because the study really is unprecedented; it's a population- based study. So we're knocking on doors trying to find women who are of childbearing age or likely to become pregnant, follow them through the pregnancy to the birth of the child and then follow the child through to age 21.
TIAHRT: If you're arranging relationship, I have a couple gals in my office that would like your help. I'm being facetious. I'm sorry.
(LAUGHTER)
KINGTON: I will resist the opportunity to comment on that one. What we did know was about maybe three or four years ago, we had an estimate of about $3.1 billion. Internal to the study, it became clear at some point that that was an underestimate of the entire package that was being piloted. Now we knew we we're going to scale it down some, but it was an underestimate.
A decision was made not to correct the estimates because the feeling was we would have to go back and correct again once we had good information from the pilot study. This was an error in judgment, in my opinion. We have now corrected that error in judgment. We are re-estimating costs. We are having a number of steps in review of the activity, including much greatly increased review from Office of the Directors.
TIAHRT: Excuse me. I'm almost out of time, so I apologize for interrupting you. You're -- I think you're on the right track by reassessing the study and any government program allowing it to grow beyond its original intent is a great temptation. So I would encourage you to keep it within the original scope because you had a great idea. Let's complete that idea rather than risk jeopardizing it by expanding it too big and getting it killed because of the size. Thank you, Mr. Chairman.
JACKSON: Thank you, Mr. Tiahrt. I've been informed that we're expecting a fairly lengthy series of votes sometime between 12:30 and 1:00. These will be the first and last votes of the day, but again, potentially lengthy. And so I am grateful to members who are honoring the time. Thank you once again, Mr. Tiahrt. Mr. Honda?
HONDA: Thank you, Mr. Chair and welcome, Doctor. Your written testimony is very good and I really appreciate its detail and it's succinct. The area I'm concerned about is an area that you took a lot of pain to discuss and that's the communities of color and the disparities. Hopefully, in your discussion and your research and your thinking that Asian-American populations are included in there because I think that's there's a myth out there that the communities don't have any problems and when you disaggregate the communities, you know that there'll be different communities with very serious problems. So in part of your work, hopefully, that will be a solid direction.
We had a bill in the last session. I believe it was H.R. 3014. It's the disparities and equal access bill. Essentially, what we wanted to do was look at all the gaps in our health system from research to delivery systems, services at the clerical level, community level; many of the areas which you have discussed in your paper here.
I was wondering, number one, in the '09 -- I'm sorry, the last fiscal year, out of the $30 billion that was allocated for NIH, I believe it was $2 billion or $3 billion was set aside -- $2 billion was set aside to study the disparities. And one, I was wondering what kind of work was done as a result of that?
Two, where in your studies were there some matching of the desire that we provide services, based upon our bill figuring out whether if you're already doing it what parts of it -- what parts of the bill are being addressed?
And then three, in the future, how will you be looking at that in anticipation of a bill being passed? Not being passed in the direction that you really want to go to, there's a parallel there for equal desire. So I was wondering whether you can comment on those questions.
KINGTON: Thank you for the question. This is an extraordinarily important area for the Agency and for the American people. First, I'd point out the trends for our expenditures in health disparities. We, as you noted, anticipated -- we estimated about $2.6 billion of our budget in '08 was devoted to health disparities research and we've define disparities populations and we certainly acknowledge that many Asian subpopulations have extraordinary healthcare problems. There's great heterogeneity across subgroups, and that's a theme that cuts across many projects of research supported by multiple institution centers, including the Minority Center.
HONDA: May I just interrupt for a second? Then for purposes of future, if that wouldn't be articulated, that would be greatly appreciated because I think once it's articulated and written down, then we know that it exists and then we pay attention to it. Thank you.
KINGTON: We will articulate it in our strategic plan and I can go on to that topic. We're in the process of starting a second wave of our strategic planning process. It's led by Dr. Ruffin and Dr. Ruffin may want to comment. We've tried to integrate health disparities research across the entire agency.
Although the minority and health disparity center clearly has the lead, we feel it's important that every single institute and center understand that they own part of this problem. And I see -- and I can personally tell you that every single institute and center director sees it as a priority. It was a priority under Dr. Zurhuney (ph) and it's also a priority in our ARA dollars.
You may note that in this large compendium of topics, one of the 15 priority areas was health disparities research. We anticipate receiving many important applications in funding them under ARA, and I think that you'll see in our portfolio we have everything from very basic research all the way through research on systems and how minority groups in health disparities populations fair within our healthcare systems. I think that you'll continue to see that broad continuum of research at the agency. And Dr. Ruffin may want to comment as well.
HONDA: Thank you.
RUFFIN: I think that the last iteration of the strategic plan as Dr. Kington stated while it had been slowed getting through the process because there was a lot of different stages that it had to go through, I can say that 100 percent of the Institute's incentives at NIH did not let that process of clearance slow them down. Many of those issues and initiatives that are listed there in that plan have already been initiated.
I think those of you who may have participated and were present in December at our summit meeting of where there was somewhere in the neighborhood of 4,400 people. The purpose of that summit was to give the ICs, the Institute's incentive an opportunity to report on where we are with the various projects that we have going on within the ICs at the NIHD institutes and centers. And I think that what was revealed at that Center is the magnitude of research in all of those areas that you just mentioned that are now underway.
HONDA: Thank you.
JACKSON: Thank you, Mr. Honda. Mr. Rehberg? And by the way, I like the idea that when Dr. Kington invokes your name if you would just step up to the mic. It saves us a considerable amount of time and there may or may not be a second round, but the distinguished institute heads and directors have traveled a great distance to participate and the extent to which they can participate. We'd be grateful.
REHBERG: Thank you, Mr. Chairman. Could you expand a little bit more on the 14,000 grant applications? You know, one of the problems that I have and I've maybe been critical of my own party from to time. I always say we want to balance the budget except keep your hands off Homeland Security and Defense. And that's where you end up with $500 toilet seats and the $200 hammers. When you're not paying attention, somebody is going to be padding the budget.
When you have an influx of money like $10 billion and all of a sudden you go, 'Oh, goody, goody, goody! Now, we can just expand what we were doing.' These may have been meritorious. However, they didn't make the cut before. All of a sudden, they're back on the table again.
Give us some confidence that, one, it's going to stimulate the economy as intended; two, that you're not just going to be throwing money at new projects that hadn't made the list before; and three, why not just use the money for an expansion or a continuation of those that you found to be meritorious in the first round rather than trying to spend it on, let's say, two-year projects and then coming back before the committee and saying, 'Well, now you've got to have a maintenance of effort because we've begun these very important projects; however, they didn't make the cut before.'
KINGTON: Very good questions. First of all, it's important to recognize that those 14,000 applications were reviewed and found to be scientifically meritorious. We received many more applications that were not funded. This was the top right below our funding level off. But it's also important to recognize that that is in the context of flat budgets.
Over the last six years, the NIH budget has essentially been flat and we've lost about 17 percent purchasing power. So there was a great deal of pent-up demand and we believe that many of those projects can be funded for two years, and all of them have been found to be scientifically of high-quality and have been reviewed by our councils.
But that's not the only way that we're using these dollars. Many institutions and centers are also committing equal amounts, if not more, to supplementing existing grants and contracts as you suggested. These are projects that are already ongoing and are either -- in which we're either accelerating or we're expanding to address new areas for existing contracts.
We released two solicitations for request for those supplements and that will be a major part of this portfolio. We have three big buckets. One is the funding of grants that were on the table, but were very high quality. And if we had had funds we would have been perfectly comfortable funding them because they were high scientific quality.
Second is supplementing existing grants and contracts through either an administrative process or a competitive process in which we solicit request.
And the third is the new grant program, such as the Challenge Grants and the GO Awards, which are only for two years.
REHBERG: And your deadline on that is what?
KINGTON: The deadline?
REHBERG: Of this various process.
KINGTON: We've released the supplement request announcements for administrative supplements and competitive supplements. We've released the Challenge Grants. We hope soon to release the GO Grant application RFAs. So we're substantially down the track of it on this and I actually think -- we have elaborate timetables, actually, to make sure that we can get the applications, review them and fund them beginning in '09. We are absolutely confident that we have the infrastructure and the reserve to, one, fund really good science; and two, fund it quickly.
REHBERG: What is your number on new jobs created with your $10 billion?
KINGTON: It depends upon the distribution across those pots. We can give you an estimate. As I said, each grant we believe supports between six to seven jobs in part or full. We can get back to you with exact dollar estimates.
REHBERG: I want not just exact dollar, but the exact job because the stimulus package was built as a jobs creation. It got more into a job maintenance somewhere along the line once they realized that it was going to be very difficult to create as many jobs as were promised. So I want an exact number that you anticipate jobs that will be created with your $10 million.
KINGTON: We'll give that to you and it's required under the reporting requirements of the act.
REHBERG: I understand that. Thank you.
JACKSON: Thank you, Mr. Rehberg. Ms. Roybal-Allard?
ROYBAL-ALLARD: The National Children's Study is a study that is extremely important for communities such as the ones I represent that are overrun with freeways and every kind of unwanted project that you can imagine. So if I may, I'd like to direct my questions to Dr. Alexander, who I believe oversees the studies. Is Dr. Alexander here?
Dr. Alexander, first, I'd like a little bit of a clarification of the response to Mr. Tiahrt's question because I have heard that some concern has been raised about the many variables that you are piloting in the National Children's Study. The concern is that it may double the budget is what I have heard. Can you explain what the reasons are for so many variables and do you share that concern in terms of doubling of the budget?
ALEXANDER: When we made the decisions to go ahead with the pilot study that was very broadly encompassing of many of the ideas, not all, that had been proposed for inclusion in the study. We did it for several reasons.
First, we thought that the best way to decide what the content of the final protocol for the main study would be would be based on experience in testing in the field of the various ideas, protocol possibilities of different approaches for recruiting subjects, different approaches for collecting data, et cetera -- that the best way to get that information was to actually test it in the field. It was never any anticipation that we would double the size of the study or even massively increase it.
However, the study itself was conceived as a public/private partnership so that in addition to the federal funds available from the appropriation we also anticipated that things that could not be incorporated into the protocol funded by the appropriation might be picked up by other interested parties; other components of the government, other government agencies, the private sector, industry, foundations, advocacy groups, whatever.
And we wanted to have an identification of things that were useful to do, but did not make the cut, if you will, of inclusion within the protocol within the financial constraints that there would be. And that we would hope that many of these other things might be picked up by these other sources; therefore, it was advantageous in addition to trying to pick the best things for the final protocol to include more things so that we might be able to offer these up to expand the reach of the study and really fulfill its purpose much more extensively than just the appropriated dollars would be able to do alone.
ROYBAL-ALLARD: OK. Also, many parents have concerns about enrolling their children in clinical studies. And this is particularly true of ethnic and minority groups who could benefit greatly from this study.
Could you please tell the committee what is being done to recruit and to retain racially ethnic and culturally diverse children? And what your contingency plan is to support study sites that do not achieve the targeted minority enrollment rates that you're anticipating?
ALEXANDER: Those are very important issues that the study has tried to address from the beginning. First of all, the study itself is one that looks like America. We have rejected the approach based on the best scientific advice we could get of a convenience-based sample in favor of a nationally representative sample so that the children included will come from of appropriate proportional representation in the population.
There will be representation from all racial and ethnic groups, socio-economic status groups, geographic distribution.
ROYBAL-ALLARD: Doctor, I'm sorry to interrupt, but my question really is what kind of outreach are you going to have in order to assure that you get the diversity that you're seeking?
ALEXANDER: OK. Very good. Let me get to that. That has been also an effort that we have made from the beginning. The outreach includes presentations to organizations that represent minorities across the spectrum -- Hispanic organizations, African-American organizations, whatever. We have presented several times to the National Medical Association, have their endorsement and so forth.
We have also charged each of the sites with a broad effort in community outreach. Each of them has a person on their staff directed toward community outreach and reaching people in the community, both directly as well as through the media, through their community leaders in organizations and so forth. So that is being done.
In addition, we have publicity that has preceded our entry into the field in the sites where the study is being done. We also have efforts under way to be sure that if we have difficulties in the field we are able to deal with them. We have sensitivity training being done for all the people who are doing interviewing and our oversight center will be looking at our minority recruitment efforts to be sure that we are making our goals. If we are not, then we are prepared to step in and increase the efforts in the sites or to increase efforts at supplementing by over sampling in other areas.
ROYBAL-ALLARD: Doctor, I'm just hoping that there will also be forms and applications and presentations in appropriate languages and that the research teams themselves will be culturally and linguistically competent.
ALEXANDER: They are and in fact virtually all of the documents for the public are in English and Spanish and we have seven different languages for the consent process.
JACKSON: I've just received an update that the votes are likely to come now. The final votes of the day between 11:30 and noon. So to the extent to which we have questions of Dr. Kington and the extent to which we have questions for institute heads or directors, please feel free to incorporate them now as it might be -- the first round might be, in fact, our only round. Mr. Ryan?
RYAN: You're running a very tight ship here, Mr. Chairman. It's all we got. That's right. Thank you very much. I've had the opportunity over the past couple of months to get involved in some different programs that are going on around the country. I went out to the University of Wisconsin at Madison and met with Dr. Richard Davidson out there who's doing a significant amount of brain research.
And one of the issues that he's trying to deal with and I think a lot of people around the country are trying to deal with, whether it's in the field of healthcare or in the field of education is how our society at this point time is dealing with stress and the ripple effect that stress has throughout our communities, throughout our healthcare system, throughout our education system.
So I have a couple of questions basically along the line of basic behavioral research, science research that you're doing, but also some more specifics as far as how we can start within our healthcare system, within the research that you're doing as we learn more and more about the functions of the brain, what we can do to prevent and teach people how to control their levels of stress so that we're not dealing with these chronic symptoms that are weighing down our healthcare system.
There's also major science now backing in schools that these kids that come to school they have problems at home. They have problems with their family. They're dealing with a significant amount of stress before they get into the classroom and the brain research is showing that these kids are -- the part of their brain that they need for working memory, for good decision making is all being affected by the levels of stress that they're having to deal with. So I have two or three questions.
One, initially probably would be for Dr. Briggs, I think, so you can come on up. What research have you supported and are currently supporting on the application of low-cost behavioral interventions, such as mindfulness-based stress reduction on healthcare utilization?
BRIGGS: Congressman, I'm delighted at your interest in this question. This is indeed a very exciting part of our scientific portfolio. We have a very robust set of superb applications dealing with mindfulness, stress reduction, and their impact on disease. Dr. Davidson's program is supported by us at the Center and he's doing very interesting fundamental neural work on the impact of meditation on the brain.
And in addition, we're looking at some very practical applications of these methods, such as effective mindfulness on post traumatic stress disorder, effect on eating and metabolic disorders and effect on the management of pain. As I think this committee is well aware, management of chronic pain -- and as all of us as doctors know very well -- management of chronic pain is very difficult, and these interventions show substantial promise in that arena. It's a very active area in our portfolio.
RYAN: Well, my next visit is on Monday. I'll be at the University of Massachusetts Center for Mindfulness and I've invited Representative Kennedy to come on over and help meet with some of the folks over there that John Cabot (ph) started that about 30 years ago and that's dealing with managing chronic pain. I think this is another area that we really need to get into.
What research are you supporting on behavioral interventions that can start early in life -- so preschool, first grade -- to promote emotional and social skills to help deal with these levels of stress that a lot of these kids -- basically, the emotional and social intelligence that our kids are really not only required to have, but need to be competitive in a global marketplace?
BRIGGS: This is an area of great promise. NCCAM has a relatively small portfolio in mindfulness in children, but I agree with you. It's an area of great promise. We're a small part of the NIH. We're only 0.4 percent of the NIH budget. We are very careful to partner with areas like OBSSR in the development of and support of the behavioral research. It's a very promising area.
RYAN: OK. Well, you can answer this in writing but -- about the research you're supporting focusing on identifying how psychosocial factors can get under the skin and affect organ systems, both for health and illness. If you can get back to me because I know the hammer is coming down from the Chairman here real soon and I'm starting to sweat.
(LAUGHTER)
RYAN: My stress level is going up right now. But just to say thank you and that over the course of this budget and next year's budget that this is something that I'm going to be extremely focused on and hopefully get you some more money. Because I think this can end up in the long run saving our healthcare system, our education system tons and tons -- and our criminal justice system -- tons and tons of money.
BRIGGS: This is an area that we also hope to be able to look at in the comparative effectiveness arena.
RYAN: Great. Thank you.
JACKSON: Mr. Kennedy?
KENNEDY: Thank you. I appreciate those questions very much. I do have a number of questions about neuroscience and the brain and look forward to getting to those, but fear that we don't have enough time today, but look forward to future hearings.
I do want to ask Dr. Kington if he could present the President of the United States with the top half-dozen most promising opportunities to fund research that would transform the outcomes of various diseases in terms of the research and its production of viable cures.
I've had numbers of scientists in my office that talk about the deficit in these research grants that you've heard the concern about all over today in this committee, and how that whether it's muscular dystrophy or if its brain science or if it's another illness and that if we had more peer review science -- that we're leaving so much of it on the table because we don't have enough funding -- that if we had more of it out in clinical trials that we would be moving it forward so much that we could really make a marked difference in people's lives.
And what I think we could make such a difference in in this country in terms of funding this committee properly is if the President of the United States went to the American people and he said, 'This is the deal. If we had these dollars we could literally expand the lifetime of people with this illness, with this illness, with this illness.'
We could literally find a cure for Alzheimer's and it would shorten the time that we could find a cure for Alzheimer's in this period of time. We could literally shorten the period of time that we could come up with a cure and find a cure for autism. We could literally make the progress we need to make on Parkinson's disease, shorten the time that we need to have a cure for some of these other illnesses.
And I think that's the way we capture the public's imagination. It's not over jobs. It's not about jobs. This is about changing the quality of people's lives. I have had it put to me so poignantly on so many occasions in my office that it just gets me wild when I think to myself that we can't get it across to the American people that their dollars, just a minuscule amount of dollars in comparison to the total budget, could be transforming their healthcare -- transforming it. And furthermore, cutting the amount of dollars that we're going to have to spend in overall future healthcare dollars.
And you heard the other day in terms of the Alzheimer's folks who were in town the other day. We spend so many dollars treating Alzheimer's patients when if we just found a cure and the research dollars we're spending on Alzheimer's is minuscule. It's pennies compared to the dollars we're spending on actual treatment.
So if you could comment just basically on that premise that we're spending dollars on treatment of Alzheimer's and on treatment of autism. And autism is now one in every 142 boys that are born have autism. And yet research is like pennies in Alzheimer's and autism compared to the treatment of these diseases. And why it is that we should be spending money on the research because the research is prevention. It's like real dividends paid if we invest in the research. Could you talk about that?
KINGTON: Well, we certainly share your passion for NIH as a good investment for the American people primarily because of its impact on health. All of us live healthier lives and longer lives because of the advances certainly over the last several decades. And I think that each of us could generate a list of diseases, whether it's Alzheimer's or many other neurologic diseases, cancer, muscular skeletal diseases, infectious disease, HIV, the obesity epidemic. We could run down the list of areas of important scientific opportunity and enormous public health challenge.
We believe that over the course of this agency we've been a good investment. So I will be discreet and say that we share your enthusiasm.
KENNEDY: What I'm asking for is I need -- we need to get concrete here. We can't be all over the board. We need the President of the United States to offer up your top most promising research in the pipeline and send it out because the American public can only handle a couple of really specific examples that we can digest in the public medium. I'm asking you -- can you get it to the president so he can put it in a speech and capture the American public's attention on this?
KINGTON: Well, your point is well taken. We will think about whether or not we can get an opportunity to do that.
KENNEDY: OK. Well, I'd encourage you to do that because it's good for your budget.
(LAUGHTER)
KINGTON: That I can't respond to.
JACKSON: Ms. McCollum?
McCOLLUM: Thank you, Mr. Chair. I'm going to set a little bit of background here. Mesothelioma kills as many as 10,000 people each year in the United States. And when I'm using that term, I'm also going to include other asbestos-related diseases. Millions of Americans are exposed to asbestos, including military personnel; and approximately 1.3 million employees on the job in construction and general industry, according to OSHA.
Now many people are going to be surprised that the use of asbestos, a known human carcinogen, has no established safety threshold level for exposure. And it's not banned for reimportation into the United States. So it currently comes back in in products. Worldwide, the World Health Organization estimates that 90,000 people die each year from asbestos-related lung cancer.
So last year, to try to see where the scientific community was on pulling all the information together, I put in some report language, and it was as follows. 'The committee is concerned about the progress and the research and the efforts to address mesothelioma and other asbestos related diseases, and therefore requests a complete report of all NIH related intramural and extramural projects and grants related to mesothelioma and asbestos related diseases.'
Are you prepared at the time or can you get back to me shortly the progress on research efforts to address mesothelioma and other asbestos related diseases through NIH who could take the leadership in coordinating what's going on out there on this disease?
KINGTON: We'd be happy to get back with you with a much more detailed presentation about the status of our current portfolio and where we think the important scientific opportunities. As you point out, this is a relationship that has been known for some time now and it's something that we can do something about and it's an important problem and we'll get back to you.
McCOLLUM: I would appreciate that. Mr. Chair, there are many opportunities out there I know for researchers who are looking at moving forward on this including at some of our universities which are facing great struggles on that right now. Angels dare to tread with picking out what is the most important disease to study. The reason why I said to kind of find out what's going on and who's collaborating and coordinating on this is quite often whether -- because military personnel are involved in this here, too. So I'm going to lay out a little more challenge perhaps.
I see the NIH as being the lead organization in the United States with what the Department of Veterans Affairs is doing, what our universities are doing, what other research groups are out there doing. Somebody has to pull this all together. We've got limited dollars and people are coming up here -- Mr. Kennedy just pointed out some great, great opportunities to improve the quality of lives for people, individuals and their families with Alzheimer's, with autism.
We have to get really smart with the dollars that we have in healthcare and I think people look to you and I want to look to you as being the leaders and telling us, the Congress, how we can go forward in working in cooperation with you in setting up good examples of how not only basic research, but peer review studies as has been pointed out and funding grants and applications can have long-term benefits. With that, I yield back Mr. Chair.
JACKSON: Thank you, Ms. McCollum. Just before I recognize Mrs. Lowey, I received an update. Votes are expected between 11:20 and 11:40. These will be the first and last votes of the day; potentially a very lengthy vote series. I have a number of questions, Dr. Kington, that have been presented by Chairman Obey and the committee that we'd like to submit for the record and would like a detailed response to those questions. Mrs. Lowey?
LOWEY: Thank you, Mr. Chairman. The fact that I have to be at a hearing next door has certainly not defined my passionate interest in what you're doing at the NIH and I am delighted to have the opportunity to have an exchange with you, and I look forward to continuing the dialogue. Thank you.
For years, I have been concerned about the impact of toxic chemicals on health and development particularly in the womb and throughout childhood. Some scientists believe these endocrine disrupters can alter cell development and organ function negatively affecting ones health throughout a lifetime. More than 12 years ago -- 12 years ago -- Congress passed legislation that I authored requiring EPA to screen and test chemicals and pesticides for possible endocrine disrupting effects.
Unfortunately, EPA has moved slowly -- which is the understatement of the year -- in developing techniques to identify disrupters. While I understand that NIH has a program to study the impact of endocrine disrupters on humans, there are still many gaps in our knowledge on this issue. I know that Dr. Linda Birnbaum, the new Director of the NIEHS, National Institute of Environmental Health Science isn't here today, but I'd like you to comment on activities of NIH when it comes to studying endocrine disrupters.
What is being done? How can we enhance this research? Would NIH be willing to convene a panel of stakeholders to develop a plan for research moving forward? How much funding would be required for this? How will the National Children's Study specifically study endocrine disrupters impact on children's health and development? If you can respond and share any additional information, that would be helpful.
KINGTON: Thank you. As you noted, Dr. Linda Birnbaum is our new director. She is a world-renowned toxicologist and actually comes from the EPA. I know they have a substantial investment of over $30 million in endocrine disrupters, both at NIEHS and the National Toxicology Program, which is run jointly with NIEHS. They've also been a leader in their BPA analysis and their monograph on that topic is also available now. And they're working closely with the FDA on a number of these issues and the EPA.
I know that Dr. Birnbaum is considering having a workshop as a planning exercise to do exactly what you suggested to bring together scientists and constituencies to come up with a reasonable sort of next step plan, both in identifying research gaps and we hope to inform our decisions about allocation of resources. I know this is a priority topic for her. We can give back much more detail about what we're doing in terms of specific activities and there's a substantial portfolio precisely because this is such an important public health challenge.
LOWEY: Well, let me thank you very much. And as I mentioned, I began working on this when a scientist came to talk to me about it and I've been so concerned about the impact of wrapping food in plastics. Recently, many mothers of newborns have been concerned about the impact of the PBA, I believe it is, plastic bottles. So I do hope that there's an urgency at the NIH to finally address these very serious issues.
KINGTON: It's certainly a priority and just as another example of ways we're trying to help develop and form policy about this, we've started an initiative with the FDA in which we will take existing NIH studies that have biologic samples that could be analyzed to look at the relationship between BPA, Bisphenol A, and various health outcomes. And we're hoping that by using existing data sets and existing studies we can develop quickly more information that will help inform some of FDA's decision making.
LOWEY: Well, thank you. It's also been widely acknowledged in the medical and scientific communities that this generation of children may face a lower life expectancy than their parents due to increased obesity and decreased physical activity. I'd be very interested in whether the National Children's Study will look at what factors, both genetic and environmental, might contribute to increased incidence of obesity.
And I'd be interested to know because there's another issue that many of us have been talking about for a very long time and not that there had hasn't been attention given to it. I see the red light is on, maybe you can respond very quickly. What research is NIH doing on this topic?
KINGTON: It's certainly a priority. It's among the most important problems facing our population with the potential of having substantial detriments in health as a result of this aging cohort that's becoming adults carrying with it the weight of overweight and obesity and all of the health implications that come with that.
I know that it's one of the topics that is to be studied in the National Children's Study and we also have a range of community-based interventions that are being developed as well, particularly targeted toward activity in children in adolescence when they begin to develop their health habits for their lives. So it's an important topic. We can give you a lot more detail about the full portfolio of investment in that area.
LOWEY: Thank you. And I just want to say Mr. Chairman that we've been having these hearings for a long time and Dr. Fauci just gets in better shape and better shape. He looks younger.
KINGTON: It's because of NIH research that he looks so good.
(LAUGHTER)
LOWEY: Thank you.
JACKSON: Let me thank you, Chairwoman Lowey. We have time for a brief second round requested by the minority, but let me first acknowledge and recognize for five minutes under the first round Ms. Lee.
LEE: Thank you very much, Mr. Chairman. I apologize for being late, so if the question is redundant please forgive me. I'm looking at your testimony and I will definitely read it. It's very good to see you and thank you for being here and all of the NIH directors and staff. Thank you for the work that you're doing to advance research and quality medical care, which your research, of course, is allowing us to do.
And also I appreciate the urgency and the diligence that NIH is putting into using the funds that we provided in the economic recovery package. I'm particularly concerned -- I'm sure you know that -- but as we dole out these funds that we're especially mindful that and insured of the fact that they will benefit all segments of our diverse population.
And we're all aware and we know that it's been very difficult for minorities to break into the research professions and compete for NIH grants. So I want to just ask you with regard to these specific funds with regard to diversity, how you plan to ensure diversity among the new investigators that will benefit from the funding in the economic recovery package?
And also if you have specific, I guess, outreach efforts for African-American, Latino, Asian-Pacific American, and Native American and other racial minority groups represented among these investigators? Are you coordinating these efforts among the institutes? And finally, extramural research facilities.
I want to make sure that minority serving institutions such as Meharry Medical School know about funding opportunities and are able to compete for these funds because we are at the beginning and at the dawn of a new day now. So I'd like to see some of the past history of for whatever reason lack of diversity, lack of inclusion be rectified and corrected as we move forward in this new era of change. Thank you very much.
KINGTON: Well, it's certainly untrue that we believe that it is essential that we have a diverse work force in order to achieve our goals of the next generation for science. If we don't do it, we won't make the progress that we need to make. I think we try to focus on integrating approaches throughout the various programs. One area that I think has great opportunity is our summer program for summer jobs.
This is an opportunity for thousands of students to work in labs in the summer of '09 and summer of '10 and were just developing an outreach program and the highest priority is to reach out to students who are from underrepresented minorities and other diverse backgrounds as well as from geographically diverse areas as well. This is a great opportunity. We're just planning it now and working collaboratively across the institutes and centers.
In terms of the construction, all of the institutions will have an opportunity to prepare proposals. We have $1 billion that's being devoted. Obviously, we will make a significant effort to assure that there is a reasonable spread of those funds across types of institutions and across the nation. So I think we're aware of lot of these issues.
And some of the institutes are specifically targeting their training programs and their diversity programs for additional resources. For example, the National Center for Research Resources, which funds the RCMI Program, which is a target program to support research centers at minority institutions, which has a base of about $300 million. We'll get about $70 million more through supplements.
We're trying to use all the mechanisms that we can use to make sure that we are diverse in how we both scientifically and geographically and along other dimensions as well. We, of course, have a continued problem with the pipeline and that's a real issue. In terms of assuring that we have diversity at every stage of the career development process and it's very clear that the diversity that we're seeing at the high school level is not translating to the diversity that we see at the level of principle investigators of grants.
We're in particular interested in funding a program that will encourage diverse and creative approaches, new approaches to addressing some of these problems. We know that there are models that work, but it's been a real challenge for the scientific community as you're well aware. There isn't a magic bullet, but we're committed to trying new approaches.
JACKSON: Ms. Lee, thank you. I understand that we have time and it's been requested for an abbreviated second round. I'm going to limit members' comments if they don't mind to three minutes. I believe we do have time before the series of votes begin and I'm going to show some leadership by example on that three minutes.
Let me first begin by saying I want to change my focus to the National Center for Research Resources. In the American Recovery and Reinvestment Act of 2009, the Congress made an investment in the research infrastructure of our nation's universities and colleges by placing $1 billion in extramural facilities account at NCRR, which had not been previously funded since fiscal year 2005.
I want to further make you aware that the Public Health Service Act says the following: 'Up to $50 million the director of the center shall make available 25 percent of such amount to' emerging centers of excellence.
Since this program has not been funded in so long, I want to remind you that these institutions such as Meharry Medical College, Morehouse School of Medicine, and Charles Drew University, which focus on eliminating health disparities which is a priority for the NIH. Can you assure me that NIH will follow the letter of this law in the way to distribute the funds of this competitive grant program?
KINGTON: We will follow the letter of the law. I'm not familiar with that specific part of our law, but we will go back and review it and we will follow it to the letter.
JACKSON: The reason I'm putting this question in the record is because I wanted to familiarize you with it and put it on your mind because we have expectations in this committee that that law be followed.
Also, I want to congratulate the NIH for organizing an impressive summit on health disparities in December. In particular, I want to commend Dr. Ruffin and the Center on Minority Health and Health Disparities -- please take your seat -- for their vision and leadership in planning such an important conference. The summit was a major accomplishment for the National Center for fulfilling the spirit of the law by bringing together all the institutes and centers at NIH and other federal agencies around health disparities. This is the type of leadership in coordination that the National Center is charged with and must continue to demonstrate with your support and the cooperation of the Institute, Dr. Kington and the Centers.
At the summit, you announced the creation of the Health Disparities Intramural Research Program at the National Center. It is good to know that the research into health disparities is becoming more prominent on NIH's campus under the leadership of the National Center. I'm always concerned about the support and resources of the National Center to effectively carry out its leadership responsibilities for minority health and health disparities at NIH.
What additional resources have you given or plan to give to the National Center to start its intramural program or enhance its coordination? I'd like you to answer it very quickly and then Dr. Ruffin if you'd comment and then Mr. Tiahrt is recognized.
KINGTON: First of all, I had the pleasure of actually announcing that program at the summit. We think that it's a great need and it's an interesting model; a new model that I think that some of the other institutes may follow as well in seating scientists across institutes and centers and having, if you will, a sort of virtual network across the institutes and centers rather than starting a new stovepipe. I think it's a great model. It's been fully supported. It was supported by Dr. Zurhuney (ph) and Dr. Michael Gottesman, the intramural program director and we worked collaboratively with Dr. Ruffin to develop it. And we will continue to support it.
JACKSON: Dr. Ruffin?
RUFFIN: As you know most of our efforts not being a disease- based center, but a trance NIH center that much of our success depends upon our ability to work collaboratively with all of the institutes and centers at NIH. And so with the intramural program, we will continue that effort and work across NIH to make sure that this comes across the way we intend it to be.
JACKSON: Thank you. Mr. Tiahrt for three minutes.
TIAHRT: Thank you, Mr. Chairman. I noticed in your written testimony Dr. Kington that you have been tasked with doing comparative effectiveness research and received $400 million to do it. Will this include comparative cost effectiveness in the research?
KINGTON: The definition for comparative effectiveness research was defined in the legislation, although there are a range of definitions. We have identified that as one of the priority areas within the Challenge Grants Program and if we receive high-quality applications that meet the definition for comparative effectiveness research that include cost we will fund them. We may not fund them with the $400 million set aside. That will depend upon the ultimate decisions by the definition that will apply to that pool of funds.
TIAHRT: So you're not certain at this point whether cost comparative research will be part of it? It could be or will be?
KINGTON: It could be.
TIAHRT: My concern with this -- and I hope that you don't fund it. I just spoke recently with a young lady named Ginny Jobe (ph). She has an immune deficiency. When she turned 65, Medicare denied her current medication and put her on something that was more cost- effective. It gives her headaches. It gives her backaches. She has an upset stomach and it doesn't work. And because of it her immune system can't fight off a lot of the common things that we are able to disperse.
My point is that cost comparative research will lead to rationed healthcare. Medicare is rationed healthcare today and she is a good example. There are many other examples. Medicaid does the very same thing. As we approach what people will call universal healthcare or single healthcare or national healthcare, it will become rationed healthcare very easily. I think it will anyway, but if you go to cost comparative -- or cost effectiveness research, it will lead directly to that path. And people who have very serious diseases will be denied the best treatment.
With the oncoming of the genome mapping, the DNA now that each of us possess, which is unique to all of us, allows us individual treatment. But cost effectiveness research will lead away from that individual treatment and group us in aggregates. And my concern is that these aggregates will not be able to meet the needs or the science that we have today.
KINGTON: Well, certainly, as a physician who practice internal medicine, I certainly understand the concern that any policy effort might severely restrict choices in whatever way. But comparative effectiveness research doesn't necessarily lead to that. Comparative effectiveness research can provide useful information to clinician, to patients and providers that make better decisions about what works under what circumstances for which patients and might actually complement the movement that you noted toward personalized medicine. So they're not necessarily opposing.
We believe that comparative effectiveness research will increasingly integrate information at a much more detailed level at the individual level and can be used to help make better decisions for everyone, but I certainly recognize the concern.
TIAHRT: Thank you, Mr. Chairman and thank you, Doctor.
JACKSON: Mr. Honda for three minutes.
HONDA: Thank you, Mr. Chairman. A real quick question on climate change in the kind of work that we're doing. Is there any thought being done on using some of the funds and looking at -- even though if it's a two-year project and it will have continuous impact -- in looking at climate change, its impact on emigration patterns and then ultimately spreads of diseases and things like that -- working with NASA, NOAA, and some of the other CDC. Is there any thought or grants that would be addressing that arena?
KINGTON: First of all, the public health community is becoming increasingly aware of the potential impact of climate change on health, and it's potentially extraordinary. Everything from increasing heat waves and individual who are vulnerable to high temperatures such as the elderly at risk of heat strokes to changes in ecologic systems that might, for example, increase the transmission season for vector borne diseases such as diseases carried by mosquitoes all the way through to drought and malnutrition.
We've begun a process of assessing what our own portfolio is in the agency. The Fogarty International Center is actually chairing a working group of individuals from across the agency to look at what our current investments are and to think about new investments. Certainly, this is an important scientific area and it could be eligible for funds either through existing grants or newly submitted grants as a result of ARA dollars.
So it can be funded under ARA dollars. Thus far, it has not been an expressly articulated area of focus, but researchers can submit under many of the initiatives can submit their own ideas for ARA dollars and this is an important scientific area.
Again, though, I think we're at the early stages in terms of the research community in understanding what the big needs are. Many of the institutes already have large portfolios. NIAID, Dr. Fauci's institute, deals with many of the infectious diseases and I'm certain would be able to fund research related to this. I don't know if you would like to comment.
HONDA: I would hope that we would be anticipatory rather than reactionary and I think that knowing the information that we have at hand in using computer assisted predictions that your NIH has a role in and trying to figure out what it is that we can anticipate.
KINGTON: We agree.
JACKSON: Mr. Ryan for three minutes.
RYAN: Thank you, Mr. Chairman. I understand from some press accounts that you've asked two of your Institute directors, Jeremy Berg and Richard Hodes to come up with a basic behavioral and social science blueprint. Could you provide the subcommittee with some more details on this initiative and when you expect the effort to be completed?
KINGTON: Of course. As you know, there has been a running discussion at the Agency about how best to support basic behavioral and social science research. There's no question that this is important for many of our major areas of focus at the Agency. Certainly, lots of prevention hinges on changes in behavior and basic behavioral and social science research informs how we understand these behaviors occur and how we develop interventions to prevent bad outcomes.
I think there was a decision made that I fully support that rather than putting all of this area into one unit at the Agency it is so important for so much of the Agency's mission that it should be spread across the entire agency. This is a challenge we've had for many areas like this; obesity, the neurosciences where we know that there are important scientific opportunities that cut across the structure of the agency, so we're following a model that we develop.
We use it in obesity. We also used for the neurosciences blueprint where we form a high level of leadership -- in this case as you pointed co-directed, co-chaired by Dr. Berg and Dr. Hodes of the Aging Institute, but also populated by Institute and Center directors in which we look for strategic opportunities to build areas of research where there are gaps and that have the potential to affect the missions of multiple institutes and centers.
And the expectation is we will have both a core funding at the institutes and centers and there'll be a pooled funding as well. This is just getting started now and will be playing out over the next year, but then the blueprint will set the stage for research over several years. I think this is the right approach. Dr. Berg and Dr. Hodes are committed to making this work. We've seen it work before and stay tuned. You'll see major changes.
RYAN: There was also in that report language that we had in '09 we asked for a progress report by March 1st of this year, I think. And asking you to use the Division of Program Coordination Planning and Strategic Initiatives as the central headquarters to do this. And so, if you could give us some insight as to what that report will entail.
I think a lot of people in the field, whether it's stress reduction or mindfulness or social and emotional learning or behavioral science in many instances are doing this already. And I think it's our responsibility as policy makers to try to break down these walls and get it into the prevention side of our healthcare plans with the insurance industry and what we're doing here. So I appreciate what you're doing and any assistance we can be. We want to be helpful.
KINGTON: Can I just note that one of the areas in the Challenge Grants is behavior change and prevention? So that's one of the 15 areas that's targeted. And we also in our transformative RO1 Program that's designed to fund really creative and innovative research. And we also specifically asked for applications on the science of behavior change. So I assure you it's at the top level.
RYAN: That's not locked into one institute? That's across the board?
KINGTON: The common fund and across the Agency.
RYAN: OK. Great.
JACKSON: The votes are coming now. We do have time to finish this round of questioning provided no other members enter the room. Mr. Kennedy then Ms. Lowey then Ms. Lee for three minutes.
KENNEDY: If Dr. Landis could come up. I'd like to thank Dr. Kington. I really want to thank my colleague, Mr. Ryan for his focus on behavioral health. I want to focus on the Institute of Neurological Disorders and ask Dr. Landis in light of the soldiers coming back from Iraq and the traumatic brain injury -- 360,000 of our soldiers suffering from TBI.
Can you talk about the coordination that is going on between NIH, DOD, the VA and to what extent that we can get all the brain science together, neuroscience research and brain research and how that research can interrelated work to benefit psychiatric disorders?
LANDIS: There has been an effort in NINDS to look at traumatic brain injury at the cellular molecular level all the way to understanding changes that may occur in brain structure and brain connectivity. NINDS as the lead institute for that has worked very closely with the Veterans Administration and with the DOD to make sure that there is not duplication, but that there is actually a good gaps analysis and programs have been targeted to specific topics.
Towards that end, we've been working in workshops with the diagnosis of TBI, definition of what actually brain changes occur, coming up with common data elements that would allow us to do clinical trials.
Of particular interest is a very new effort coordinating with UHSI, Uniformed Health Services Institute, the Naval Hospital and as you know Walter Reed will be moving out to the Naval Hospital with the NIH to come up with a very innovative program to look at TBI and PTSD and better ways to treat it. So I think there's a lot going on.
KENNEDY: Is it being run out of NIMH? NSO (ph) told me there's a blue kind of unofficial organization of brain science kind of being done through NIMH.
Landis: So there is a coordinated effort. So NIMDS has responsibility for TBI, NIMH for PTSD and we recognize that the same brain changes in brain structure may underlie both and we are working very closely together to maximize our understanding of brain plasticity to make a difference for soldiers who are coming back with both of those disorders.
KENNEDY: I'd just like to -- if you could get me what's going on in terms of coordination.
LANDIS: Absolutely. We'll give you a detailed answer for the record.
KENNEDY: And in terms of Dr. Kington, if you could just get me what's going on in terms of research on the ASMA, ADHD, allergies and autism and whether states with EPSCoR receive any additional consideration for applying for stimulus funds. That would be terrific.
KINGTON: We'll prepare the response.
JACKSON: Ms. Lowey for three minutes.
LOWEY: Dr. Kington, you and I agree that peer reviewed medical research is at the core of NIH's mission. Peer review grants to doctors and scientists throughout the country are absolutely critical to make progress in finding a cure for treatments for thousands of diseases and disorders. But I understand that about $800 million of NIH's stimulus funds will go to the Office of the Directive for various research grants on various diseases.
Can you share with the committee what your priority areas are for these funds? How many new grants do you expect to be funded? And will you be able to use any of the stimulus funds to place a few big bets on promising, but risky research that you would not have been able to pursue otherwise?
KINGTON: We are in the early stages of planning for the entire allocation of $800 million, but we are focusing precisely on those areas; areas that cut across the mission of institutes and centers, areas where an infusion of large dollars can move a whole field ahead and riskier investments. So we've committed $200 million toward the Challenge Grants Program, again, targeted to those specific areas.
We've committed $100 million to the Grant Opportunities Program, which we anticipate under which we'll receive many creative large grant applications. And then based on -- we won't make the final decisions of allocation until we see what institutes and centers have done because then we can decide -- look at the entire portfolio and see what gaps there are.
We're also funding the summer program for students from the Office of Directive; that's $21 million right now and it may go higher if we get more applications. So we made those commitments for about half. The other half we're waiting until we have a better idea of what the commitments are of the institutes and centers and then we can make decisions about which initiatives we will fund.
We generally won't fund at an individual grant level, but we'll fund specific institutes and centers initiatives that have broad application and cut across the mission of institutes and centers. We're making those decisions and we will try to complement the decisions of institutes and centers.
LOWEY: Thank you very much.
JACKSON: Ms. Lee for three minutes.
LEE: Thank you very much. Can I ask Dr. Rodgers to come forward just a minute, please? And let me just thank you first of all and the National Institute of Diabetes, Digestive and Kidney Disease for responding with regard to the whole issue of sickle cell anemia and the validity of the A1C test.
I just wanted to know, first of all, I think the public awareness campaign to educate the public about that was effective and it was very good and I just needed an update from you on the status of laboratories and physicians and others who need to know this information. Do they all know now? Do we need to do more? What's going on?
RODGERS: Thank you for the question. The question relates to the use of hemoglobin A1C, I think that you posed to me two years ago that some were using that to actually diagnose diabetes and it was particularly confounding in patients that had hemoglobin variants, such as sickle cell trait.
While A1C determination is certainly not the standard at the moment for diagnosing diabetes, it certainly is very important for monitoring the course of the disease because it gives you the average value of glucose control in the proceeding two to three months.
At the time that you asked me the question, there were about 20 various assays for measuring hemoglobin A1C. And unfortunately, six of that 20 were unreliable and gave unreliable results in individuals that had sickle hemoglobin or other variants. The NIH did with their profiting develop this education campaign, which got out the message, both to individuals, to physicians as well as the general public and has been quite effective in diminishing the utilization of those unreliable methods in those areas.
We have ongoing funding to a national glycol-hemoglobin standardization program out of the University of Missouri that continues both looking at the final remaining assays as well as getting the message out, not only in this country, but worldwide because of course there are many more people in other areas of the world that have hemoglobin variants than in the United States. So your prompting that question, I think, has had a major impact.
LEE: Thank you very much. And thank you so much for responding so quickly to that because many, many people were being, I think, mistreated as a result of that.
RODGERS: Thank you for your interest.
JACKSON: Let me remind members that they may submit questions for the record which will be provided to Dr. Kington for an appropriate response to the committee in writing. I want to thank members' indulgence as well as Dr. Kington for allowing me to chair my first Labor, Health and Human Services Subcommittee.
(APPLAUSE)
JACKSON: And to all of the distinguished scientists, chairmanships around this place are very hard to come by. It's taken me 10 years to sit in this seat and I'm reminded by Chairman Obey that I long one day to have my picture hanging in this austere body and Chairman Obey reminds me that members of Congress usually get hung before their pictures do.
(LAUGHTER)
JACKSON: The committee is adjourned.
KINGTON: Thank you.
