March 16, 2007

FY2008 BUDGET RESOLUTION

 

On March 15, 2007, the Senate Budget Committee marked up its “Concurrent Resolution on the Budget for fiscal year (FY) 2008.” The resolution was approved on a 12-11 party line vote. While both the President’s budget request and the Senate proposal would balance the Nation’s budget by 2012, Senate Budget Committee Chairman Kent Conrad’s (D-ND) plan rejected President Bush’s spending cuts for health care and education by providing $18 billion more for discretionary spending than the President proposed in his FY2008 budget. Specifically, the Budget Committee proposes $949 billion in overall discretionary spending for FY2008, which is $16 billion above the President’s FY2008 request. The additional $2 billion is provided through an accounting maneuver in the form of “advance appropriations” from the following fiscal year. The Chairman assumes that most of the discretionary spending above the President’s request will go toward domestic programs, which potentially will benefit the programs FASEB advocates for, including NIH, NSF, DOE’s Office of Science, USDA’s National Research Initiative, VA medical research and NASA.


You may remember that the Budget Resolution is a concurrent resolution of the Congress that establishes a general framework for subsequent congressional action on spending and revenue bills. While it does not require presidential signature and does not become law, the budget resolution does place limits on how much money the appropriations committees are allowed to allocate to discretionary programs. Therefore, as stated above, the Senate Budget Committee proposes to cap discretionary spending at $949 billion in FY2008. However, the authority to allocate discretionary spending among the hundreds of government programs belongs to the Congressional members serving on the twelve appropriations subcommittees.


The Budget Resolution is expected to be debated on the Senate floor at some point next week. The House Budget Resolution is expected to be marked up next week.
 

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ACTIVITIES INVOLVING PRESIDENT'S FY08 BUDGET REQUEST

 

FASEB Encourages Senate to Support Dear Colleague Letter to Increase NSF’s Budget
FASEB is working in partnership with the broader physical science community to support an effort to recruit additional Senators to sign-on to a Dear Colleague letter from Senators Christopher Bond (R-MO) and Joseph Lieberman (I-CT) requesting that the Appropriations Subcommittee on Commerce, Justice, Science and Related Agencies provide $6.43 billion to the National Science Foundation (NSF) in FY2008. FASEB sent an individual letter to every Senator who had not signed on to the Dear Colleague letter and provided a thank you letter to those Senators who had already signed on to the letter.


VA Chief Research and Development Officer Testifies before House Committee
On March 14, 2007, Dr. Joel Kupersmith, Chief Research and Development Officer, Veteran’s Administration (VA), testified in front of the House Appropriations Subcommittee on Military Construction, Veterans Affairs and Related Agencies, to defend the Administration’s FY2008 budget request for the Medical and Prosthetics Research Program. President Bush’s FY2008 budget request for the program is $411 million. Dr. Kupersmith remarked that the FY2008 budget proposal would fund 2,100 high priority research project grants, and stated that the research is paying dividends in promoting good health and managing chronic conditions among the veterans population. Subcommittee Chairman, Chet Edwards (D-TX) expressed support for the research program and asked what percentage of its budget would fund new research project grants in FY2008. Dr. Kupersmith responded that 13.1% of its budget would be directed toward new research project grants in FY2008. Chairman Edwards noted that the program’s flat budget, coupled with the fact that 87% of its funds are tied up in FY2008, “doesn’t leave much room to confront the pressing problems veterans are facing.” Ranking Member Roger Wicker (R-MS) explained that he is eager to be educated about VA research after spending twelve years on the Labor-HHS-Education appropriations subcommittee and learning about the wonderful research NIH supports. Representative Wicker asked if it always has been the philosophy to support VA research intramurally, and expressed an interest to know if VA researchers leverage its research dollars with NIH funding. Dr. Kupersmith explained that many researchers supported by the VA have joint appointments at nearby research institutions and often also receive NIH funding. In fact, Dr. Kuprsmith provided the following accounting in terms of how much NIH funding is supporting veterans research: $589 million in FY2003; $568 million in FY2004; $624 million in FY2005; and $684 million in FY2006.


House Appropriations Hearing on NIH
On March 6, 2007, Dr. Elias Zerhouni, Director, National Institutes of Health, testified before the House Labor, Health and Human Services, Education and Related Agencies appropriations subcommittee on the President’s FY2008 budget request for NIH. Carrie Wolinetz, FASEB’s Director of Communications, provided the following summary of the hearing.


Members in attendance: David Obey (D-WI, Chair); James Walsh (R-NY); Michael Honda (D-CA); Barbara Lee (D-CA); Jesse Jackson, Jr. (D-IL); Dave Weldon (R-FL); Jerry Lewis (R-CA); John Peterson (R-PA); Betty McCollum (D-MN); Lucille Roybal-Allard (D-CA); Tim Ryan (D-OH); Ralph Regula (R-OH); Dennis Rehberg (R-MT)


Witnesses: Dr. Elias Zerhouni, Director of National Institutes of Health
[Note: Although Dr. Zerhouni was the only witness to testify, he was accompanied by a number of IC Directors who participated in the Q&A, including: Dr. John Niederhuber (NCI); Dr. Elizabeth Nabel (NHBLI); Dr. Anthony Fauci (NIAID); Dr. Duane Alexander (NICHD); Dr. John Ruffin (NCMHHD); Dr. Griffin Rodger (NIDDK, Acting)]


Opening statement – Obey

  • I’m asking everyone who appears before the appropriations committee, what will the country look like in 10 years? In your case, what will be the scientific opportunities? The health needs?

  • The budget sent by the President may be called a status quo budget, but this is not reflected in reality because it is not adjusted for inflation and population growth. On a per capita basis, it amounts to a cut, a step backwards.

  • We were forced to cut many programs in ’07 because we were left to finish the budget of the previous Congress, but we prioritized NIH, which received a more than $600 million bucks increase.

  • What we’re seeing from the President in ’08 is a cut, and OMB is treating NIH like the “Bank of Bethesda” by taking money out for the global HIV / AIDS fund; this is a worthy cause but given the current fiscal situation, it doesn’t make sense to take it away from NIH.

Opening Statement – Walsh

  • Continually impressed with the discoveries coming out of NIH and believes that those discoveries really do affect people’s lives and health.

  • Wants to ensure that these advances are actually getting to doctors.

  • We need to move research advances more quickly into practice – understanding that there are safety concerns and standards that must be satisfied.

  • Congress has increased NIH’s budget significantly, therefore we need to make sure that there is strong financial management at NIH, something Zerhouni as the Director has espoused; must ensure that we are investing wisely.

  • Likes Zerhouni’s model of the 4P’s (predictive, preemptive, personalized and participatory) of health care 􀃆 recognition that we are moving towards more chronic diseases.

Opening Statement – Zerhouni

[Note: Zerhouni used many of the same slides that have been presented in other forums, showing decreasing rate of disease, cost per American, NIH priorities and his 4 P’s approach – the statement can be read here - a very brief summary is below]

  • NIH supported research has contributed to considerable life saving and cost saving advances in heart disease, cancer, age related disabilities and diabetes

  • Major breakthroughs have occurred in the development of the HPV vaccine, the identification of a new molecular target for an HIV vaccine, and in the area of RNAi

  • Challenges include: shift to chronic disease; aging population; rising health care costs; health disparities, etc.

  • Moving towards more proactive, rather than reactive medical care – predictive, preemptive, personalized and participatory (4P’s); identifying molecular cues that can be targeted before a disease begins, rather than after it manifests.

  • A major challenge is biological complexity, the more we learn the more complicated we realize the molecular and cellular environments we’re working in are.

Question and Answer Session:
[Note: Answers are by Dr. Zerhouni unless otherwise indicated]


Obey
Q: About the decision to cut the National Children’s Study, was that a decision based on the budget or on science?


A: We have to set priorities within the budget. If we were to fund that, it would drastically reduce NICHD’s ability to fund other research.


Q: Don’t worry, we’ll put that money back and it won’t have to squeeze the research budget. I have a series of questions, but we don’t have time for them now. I’ll give them to you after the hearing and I would like you to submit answers for the record. For example, I have some questions about NIH’s conflict of interest policies and how they’re working out. And how those policies are being used for grantees. I also have some questions regarding contractors. But for now, can you tell me why NIEHS received such a large cut?


A: The decrease for NIEHS was not out of the ordinary. In addition, they are receiving an additional $40 million for the genes and environment studies.
 

Q: Which reminds me, I also have a question for Dr. Collins regarding genetic discrimination which I’ll submit to him in writing. Hopefully we can finally get a bill to the floor. But tell me what happens in the outyears of funding. In real per capita terms, the NIH budget has decreased. What would happen if that trend continued for the next ten years?
 

A: Clearly there would be an impact – a loss of purchasing power is a loss of purchasing power. Nearly 75 percent of our budget goes to funding scientists. At the end of the day, a loss of purchasing power means a decrease in the number of scientists you can support. But the absolute numbers are not as important as what we’re likely to lose. New investigators are very vulnerable in times of lean funding, as are clinical tirals.
 

Q: (More of a commentary, really) The Administrations budgetary request represents a $511 million decrease. Sometimes there are ways to reduce the deficit besides cutting programs like NIH. I remember in 1979 when we were told we had to reduce the budget by $16 billion or we would be overwhelmed by the deficit. So we sat for days in Senator Byrd’s office and we found $16 billion to cut. And the deficit doubled, because of what was going on in the economy.
 

[Note: Congressman Regula entered at the very end of the hearing and asked a couple of questions about pandemic preparedness by the Office of Personnel Management, Down’s syndrome, and a water-purifying technology, to be used to make baby formula in developing nations – but there was nothing of significant interest.]


Walsh
Q: Regarding human embryonic stem cell (hESC) research, tell me about the new avenues for pluripotent cells. Is there any chance that we can move beyond the debate and eliminate the need for hESC? I’m struck by results from groups at Harvard and in Japan who have succeeded in reprogramming adult stem cells or the use on cells from amniotic fluid. Can we put the hESC debate to rest?
 

A: The goal of stem cell biology is to understand the basic biology of programming that takes place at the level of DNA. Adult stem cells are only one side of the coin, in that we are looking at our ability to reprogram these cells, something we have had limited success in. But embryonic stem cells are not yet programmed, they are blank slates, so we need to study them to understand how programming works. From a scientific standpoint, science demands we pursue all avenues of stem cell research.
 

Q: But what about these groups at Harvard and Japan, haven’t they already reprogrammed adult stem cells into pluripotent cells like hESC?
 

A: No. The Harvard group fused an embryonic and adult stem cell together and produced an ES-like cell, but they haven’t figured out what to do about the additional chromosomes, so it is too soon to tell. In Japan, they were able to use 4 factors to reprogram adult stem cells in the mouse, but this research is in very early stages. Ultimately, we would like to be able to identify all of the factors that are involved in molecular reprogramming, but we need to continue to pursue the basic research. From a scientific viewpoint, we should be investing in this.


Jackson

Q: What is your vision of the role of the National Center on Minority Health and Health Disparities?
 

A: Health disparities are one of NIH’s top priorities. NCMHHD needs an adaptive strategic plan and we need to focus on training a more diverse scientific and medical workforce.
 

Q: I want to talk about the recent IOM report on health disparities. They criticized NIH and NCMHHD for not publishing a strategic plan for the ’04-’08 period, I gather such a plan exists but has not been approved? Is there a strategic plan at NIH regarding health disparities?
 

A (Ruffin): We are going to put it on our website and will send you a copy, although there is nothing specific directing us to send a copy to Congress.
 

Q: Back to the IOM report, it seems that NIH continues to struggle with the role and authority of NCMHHD. Do the ICs all understand and recognize this authority?
 

A: We take the IOM report very seriously. Part of the Road Map was focused on health disparities. As far as I know, all ICs are aware.


Lewis

  • Lewis began by relating a story in which his granddaughter was found to have what was thought to be a stage V melanoma, via a referral at Loma Linda Hospital, she ended up consulting with NCI 􀃆 turns out it was a dysplastic naevus (?), she’s doing fine, but he wanted to express gratitude on behalf of his family and the nation

Q: While there is non-partisan support for research, we are also in a time of limited budgets. There are some who feel NIH is like a club, once you’re in, you’re in. If you’re out, you’re out. For example, in Loma Linda, there was a innovative program on proton treatment which NIH didn’t want to support, but turned out to be very important in cancer diagnostics. There are those at NIH who feel the pie should be divided evenly. I don’t agree. How do we cut off folks that are unsuccessful and diversify the club?

 

A: This is why we appreciated passage of the NIH Reform Act, whose provisions will help NIH track, through OPASI, our portfolio and how we are spending the money. The truth is that only 50% of NIH grants get renewed and less than 5% of scientists hold on to an NIH grant for 20 years or more. So there is high turnover.
 

Lee
Q: I also have questions about minority health disparities. Although we may be making gains in health in the general population, as Dr. Zerhouni cited in his slides, this in not true among minorities, who may suffer twice the rate of conditions like coronary heart disease. I specifically want to know about the A1C test for diabetes, which can yield a high incident of false positive among African Americans with sickle cell disease. I’m
very concerned this is leading to patients taking medication for a condition they don’t have.
 

A: (Rodgers) We need to make sure that treatments and knowledge are available in the communities we wish to reach. Diabetes has reached epidemic proportions in some minority communities. Our goal is to prevent pre-diabetics from becoming diabetics and we’ve shown that modest lifestyle adjustments can have huge impacts. The real question is how do we translate this into practice? We are working with the CDC and both public and private partners on that.
 

Q: You didn’t answer my question about A1C – shouldn’t patients be warned?
 

A: [Note: Rodgers did his best here to explain the science behind the diagnostic test, but the truth is that this is a regulatory question beyond the scope of NIH] I believe most physicians know that in individuals with sickle cell disease to use a different test.
 

Weldon
Q: Thanks for assembling a workshop so quickly regarding the Vaccine Safety DataLink in regard to whether vaccines are connected to autism. I note that the experts at that workshop concluded that the data in the VSD, on which the claim that autism is not connected to vaccine additives, is flawed. But I wanted to ask you about translational research, how much progress are you making in this direction? Given your limited budgetary discretion as Director, do you think the institutes are making progress in translation?
 

A: ICs have contributed across the board to facilitate translation. This year we have also established the CTSA.
 

Q: Regarding clinical trials and clinical research, is money a key problem? Can universities not afford to do clinical trials anymore?
 

A: Clinical trials are very expensive, especially as safety concerns and regulations increase. They are very difficult to do in a tight or decreasing funding environment, which is why IC directors often look to them as the first thing to cut.
 

Q: Can you please expand on the discovery of a new target for HIV?
 

A: (Fauci) Through crystallography, we have identified a cross-reactive epitope on HIV that looks very promising for a future vaccine.
 

Q: You mentioned that the drop in cardiovascular disease is only 30% attributable to statins? Is that true? What else contributes?
 

A: A number of factors – smoking cessation, high blood pressure medications, anti-clotting drugs, etc.
 

Q: But the most recent sudden drop, over the past few years, is probably because of statins, right?
 

A: Most likely, yes.
 

Honda
Q: I like your focus on pre-emptive, predictive medicine and this future looking paradigm. But how do you match that to your budget and priority setting? How is your budget designed to meet those goals?
 

A: It is difficult to match a budget to a paradigm, especially since you would really have to look at the individual ICs. But you can see cross-cutting themes in this direction, such as the focus on biomarkers.
 

Q: I understand that, but the budget process is about setting priorities. If you want to focus on the future paradigm, the budget needs to reflect that. Two other issues, I have obstructive sleep apnea, so I’m curious what your doing on sleep and also have an interest in minority health disparties.
 

A: (Nable and Ruffin) Briefly report on sleep and minority health disparities activities
 

Q: I want to ask a question about NIH’s policy of requiring funded researcher to place their publications in a freely available electronic database after six months. I have heard from a number of people that they are concerned about the scientific societies that run the peer review system, that this is a movement toward peer review being reduced or paid for by tax payer dollars. I think you must work with the scientific societies to make sure peer review is preserved. Can you address what you’re doing in that regard?
 

A: We agree with the principle of not damaging peer review and I will submit the answer to the rest of your question in writing for the record.


Rehberg
Q: Thank you for the Road Map programs. I’m curious about an RFP for a new anthrax vaccine that was recently rescinded, why was that withdrawn?
 

A: (Fauci) Put out an RFP for a third generation anthrax vaccine, upon receiving the proposals, we felt the science was not mature enough and the companies were not ready to move forward. We need more basic science.
 

Q: I traveled recently to Cuba with Congresswoman Lowey and we toured a medical research facility. Are our policies towards Cuba preventing us from sharing ideas? Do you communicate with Cuba, is there a chance they could have a great idea or discovery and we would miss out?
 

A: We have the flow of information that takes place through scientific societies, meetings and publications, but I don’t think NIH researchers travel to Cuba. From a scientific standpoint, the more sharing of information the better.
Statement from Rehberg: If we can send down crops, we should send down scientists to share ideas!
 

McCollum
Q: Concerned about NIH as a pass-through for the Global HIV / AIDS fund? Would your paperwork, in terms of budget submissions, be easier if we didn’t do it that way?
 

A: Well, it is health related, so NIH has always made a contribution. In this case, our contribution has been raised an additional $200 million (to a total of $300 million) out of a total $232 million increase for ’08. Is there a better way to do it? I leave that up to the appropriators.
 

Q: [Note: It took McCollum quite a while to ask this rather rambling question and when she eventually did, the wording was somewhat confusing – this is a distilled version, but Zerhouni et al.’s answer does not fully address it, I suspect, because it was not very straightforward] In terms of programmatic losses related to global health and U.S. competitiveness, what lost opportunities have you experienced as a result of decreased investment in basic research?
 

A: Worldwide, all governments are investing in life-sciences – this is the battleground of competitive science today. The U.S. is still number one by far, but we are no longer as dominant as we used to be.
 

A: (Fauci) The U.S. is still the leader in the field of infectious disease, but global health is becoming a more important component in what we do, particularly as relates to infectious diseases in developing countries.
 

A: (Nabel): There are clearly problems in health care delivery throughout the world. Hypertension, for example is a huge problem is some areas of the world because of lack of adequate treatment, diagnostics and knowledge. We are proud of the fact that our training programs are used to train scientists from all over the world who then go back and apply that knowledge in their home countries. But we are now training 44% less foreign scientists through our training programs because of reductions in funding.
 

Peterson
Q: Is it true that the current generation, for the first time ever, does not have a longer life expectancy?
 

A: Hard to say - depends on the impact of obesity and emerging diseases.
 

Q: Are we a less fit nation?
 

A: We are seeing a decrease in disabilities in the elderly, but the rates of obesity in younger generations is very concerning.
 

Q: And aren’t mental health diseases a growing problem?
 

A: If you look at not just morbidity and mortality, but quality of life measurements, mental health disorders rank 2nd in terms of health problems facing us.
 

Q: I come from a rural district where we don’t have a lot of psychiatrists or other mental health professionals, so most people end up going to their family doctor. These general practitioners tells me that more than 50 percent of the patients they see are depressed. Does that seem especially high?
 

A: I don’t have the numbers with me, but it is true we need to translate what we know about mental health intro practice. This is why we’re focusing on practical clinical trials. And it’s true we’re seeing mental health issues in the young. I’m going to let Dr. Alexander talk about this in relation to children.
 

A: (Alexander) We’re seeing two main mental health disorders in children, depression and ADHD.
 

Q: How important is physical activity in mental health? A: (Alexander) Although the magnitude or extend of the impact is not clear, clearly there is a link. However, we are definitely seeing growing evidence that today’s children are missing out on outdoor activities and interaction with the natural environment which is probably detrimental.
 

Q: [Note: This is a summary of Peterson’s fairly passionate statement on the importance of exercise] Well, I definitely think there’s a link between mental illness and exercise. I have a lot of members of my family suffering from mental illness. I don’t and I think it’s because I am very physically active. You never see people who are at the gym three, four times a week suffering from depression. They’re usually happy. Why aren’t our physicians telling their patients to get out and swim, to get out and run? Whose job is it to get people exercising?
 

A: (Alexander) As you might imagine, it is very difficult to get people to comply, even if they have the information.
 

Roydal-Allard

Q: I am very interested in the longitudinal Hispanic health study. How much money is being dedicated to this, which IC is taking the lead?
A: (Nabel) NHBLI is the primary institute and we are spending $61 million over 6 years, trying to work with outyear commitments so we don’t diminish our capacity to do other
research. I don’t like to start research projects I can’t pay for, but we are dedicated to this study and other longitudinal studies, like the Framingham heart study.
 

Q: I am also interested in early diagnosis of genetic disorders. I will be introducing a newborn screening bill next year. Can you talk about this topic?
 

A: (Alexander) There are clearly very positive results from newborn screening – leading causes of retardation, like PKU, have virtually been eliminated because of screening. We’re advancing to new technologies to help, such as chips and microbeads. This fits in well with Dr. Zerhouni’s preemptive medicine strategy.
 

Ryan
Q: I’m disturbed by the report that life expectancy has decreased, but admire what you do for only $44 per day. Can you tell me about the current status of the embryonic stem cell ban? Has this ban on funding led to investment by other countries, such as those in Asia? What is the long term effect on our ability to reach new discoveries, is there a brain drain?
 

A: If you look at the hESC research NIH is funding, we have been able to make progress, even with the 21 approved lines. From a purely scientific standpoint, we need to allow our scientists access to as many research models as possible, including more hESC lines. There a race going on to understand the basic mechanisms of programming, as mentioned earlier, trying to crack the code that can be used to reprogram cells. But I wouldn’t say there’s any evidence of a major brain drain problem, scientists are staying here and still working on hESC research. But there’s no doubt that in terms of publications, the number of international papers on hESC is increasing relative to the number of U.S. publications, although we are still dominant. We are currently holding our own in this field, but that may not be the case looking forward. The country that cracks the code of programming will win, it will be like recreating Microsoft.
 

Q: Can you tell me whether NIH is doing any research on stress? Because it seems to me that stress in life is a major factor in many of the diseases you mentioned, heart disease, high blood pressure, mental illness. And I fully agree with Congressman Peterson that there’s no emphasis on physical education or fitness, so there’s no outlet for stress. What is NIH doing to address the problem of exercise and physical education.
 

A: This is a multifactorial problem and is not just related to health care. It involves urban planning and community development and education. For example, if we were to not allow elevator usage, except for those who were disabled, for the first three floors of any building, and forced people to walk up the stairs, we could reduce obesity in this country by more than 25 percent.

 

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INSIDE (The Beltway) SCOOP - Jon Retzlaff, Legislative Director

 

The Senate Budget Committee took a huge step in the right direction this week when it approved an FY2008 budget that would provide additional spending for non-defense discretionary spending and expressed its support for providing NIH with an increase in FY2008 of at least $700 million above the President’s request. While documents provided by the Budget Committee did not specifically reference their intent to increase NIH’s budget by at least $700 million above the President’s request in FY2008, budget committee staff clearly communicated this information during the Budget Committee mark-up and in response to a question from Senate Budget Committee Ranking Member, Judd Gregg (R-NH).


Senate Democrats strongly support Budget Committee Chairman Kent Conrad’s decision to add an additional $18 billion for domestic discretionary programs, and it’s expected that the House Budget Committee will approve a similar increase for discretionary spending when it marks up its bill next week. Senate Democrats pointed out that the $933 billion cap for discretionary spending proposed by the President in FY2008 budget is $13 billion below the amount needed to maintain purchasing power for current programs. In fact, under the President’s cap for discretionary programs, cuts would occur throughout government, including at NIH, CDC, the Department of Education and the Department of Labor. House Appropriations Chairman David Obey (D-WI) actually pointed out during NIH’s appropriations hearing that the President’s FY2008 budget request would result in a $511 million cut in program level funds at the agency. Representative Obey stated that he intends to provide additional funds to NIH in FY2008 in order to ensure that the agency does not fall further behind. Of course, this action by Chairman Obey would require the availability of additional funds for domestic discretionary programs, which the Budget Committees are in the process of doing.


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FASEB’s Washington Update is brought to you bi-monthly by the FASEB Office of Public Affairs. We welcome your questions and comments – please contact Carrie Wolinetz at cwolinetz@faseb.org or 301-634-7650. For more information about how to get involved in research advocacy, visit: http://capwiz.com/faseb/home/

 

   
   
 

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