107th Congress

Report: National Institutes of Health Fiscal Year 2003 Budget Overview—Hearing Before the House Appropriations Subcommittee on Labor, HHS, and Education—March 13, 2002

Members Present

Representatives Ralph Regula (R-OH), Chairman; Dan Miller (R-FL); Roger F. Wicker (R-MS); Randy "Duke" Cunningham (R-CA); Don Sherwood (R-PA); David Obey (D-WI); Steny H. Hoyer (D-MD); Nancy Pelosi (D-CA); Nita M. Lowey (D-NY); Rosa DeLauro (D-CT); Jesse L. Jackson, Jr. (D-IL); and Patrick J. Kennedy (D-RI).

Witnesses

Ruth L. Kirschstein, Acting Director of NIH, accompanied by: Yvonne Maddox, Acting Deputy Director of NIH; Wendy Baldwin, Deputy Director for Extramural Research; Michael Gottesman, Deputy Director for Intramural Research; Sue Quantius, Associate Director for Budget; Charles Leasure, Deputy Director for Management; William Beldon, ASMB, DHHS

Summary

The hearing opened with several tributes to Dr. Kirschstein. Mr. Regula said that millions of lives have been improved because of what she had done, both as a researcher and as a leader. He told her that she had been especially blessed because she had an opportunity to leave a great legacy. He was joined by Representatives Obey, who called her a "precious national asset;" Hoyer, who called her "a personal asset;" and Wicker who likened her to "Moses looking out over the Promised Land and speaking to the children of Israel about what to expect in the future."

The hearing focused rather specifically on how and to what extent NIH is able to translate the results from basic research and move them into the practicing community. The Members from rural states, particularly Mr. Sherwood, noted that studies have shown that there is a lag time of 20 years from drug discovery to practice. There were many questions that arose from reports of the NIDDK study on obesity as a major factor in the development of diabetes. This study was highlighted by the Secretary of HHS in his hearing before this Subcommittee and generated a number of questions and comments from Members. All questioners expressed concern that, despite what is known about this and other diseases and conditions, it is very difficult to change human behavior. In particular, there was concern about the incidence of cases of Type II diabetes occurring in children and the lack of exercise in schools as well as the introduction of foods and beverages at schools that contribute to obesity. Both Representatives Obey and Hoyer, joined by Mr. Regula, expressed concern about the post-doubling years and tried to elicit from NIH an agreement that the out-year proposals of 2.1 percent increases for FY 2004 and beyond would be insufficient to support even the annual costs of renewals of on-going NIH research grants. Mr. Cunningham and Mr. Wicker also pressed NIH on the earmark for cancer research included in the FY 2003 President's Budget and asked whether it was a positive or negative issue. Mr. Miller noted that this item in the President's Budget made the Subcommittee's job that much more difficult to resist other earmarks from the NIH budget. There were some issues raised in this hearing which were also posed to the Secretary. Representative DeLauro probed further into whether NIH has a mechanism to recover some of the costs of research on pharmaceuticals which occur in concert with the private sector, and Members requested several responses on this topic for the record.

Purpose of Hearing: The hearing was held by the House Appropriations Subcommittee responsible for determining the appropriations levels for NIH. This hearing provides an opportunity for the Members to ask NIH and its Institutes and Centers questions about the FY 2003 request and other topics related to NIH and its research.

Opening Statements

In her opening statement, Dr. Kirschstein noted that the current budget proposal is $27.3 billion, an increase of 15.7 percent over FY 2002. This figure completes the original commitment and enables NIH to continue to take advantage of the opportunities now at hand to understand diseases and to improve health. She mentioned the completion of the draft of the DNA sequence of the human genome and the new field of proteomics, which is the computer-aided analysis of the patterns present in large sets of proteins, which we believe will help with the goal of understanding the function of those proteins. She highlighted recent studies which have shown that heart cells can regenerate, and if the proper materials and sustenance are given to them, that can stimulate the regeneration so that it can be harnessed and enhanced, thus increasing not only survival but the health of the previously damaged heart. This budget would fund a total of 9,854 new and competing research grants and a total of all grants research grants of 38,038, the highest annual total ever. She provided an update on the construction of the Clinical Center. She noted, however, that due to certain unresolved issues that had occurred between that contractor and the development manager, a new construction manager has taken over and presented to NIH a proposed guaranteed maximum price in excess of original estimates. NIH is working with DHHS and OMB to validate both the new cost and revised schedule to develop options for covering the additional costs.

Questions

Representative Regula:

(For Representative Young) I was surprised to learn that every hour, someone dies from oral cancer. What is NIH doing to address early diagnosis and prevention of oral cancer? Is this associated with tobacco use? Can you change the survival rate with early detection and treatment?

Can you describe how an investigator makes a proposal to do research? Does the investigator define how the research is to be done? Can an institution suggest to NIH that a certain kind of research should be supported? Does research sometimes lead to unexpected results? Is a normal project life 3 years? When you make a grant, are the funds obligated at that time?

What happens if we don't appropriate enough funding to complete the grant? If we flat-funded you in FY 2004, would you be able to pay the commitment base? Are you comfortable with this?

Do your Directors work with grantees? When a grant is completed, is the result published? So a 4-year grant would have a continuous flow to the CRISP website for all to read?

I understand that OMB is working on basic research metrics. Can you discuss this? Will it be ready for the FY 2003 grant proposals? What are you doing to respond to GPRA?

How has medical science changed since you first came to NIH? Does NIH have an impact on medical education? Does NIH have information activities at medical schools?

Representative Obey:

One of the most difficult jobs a Congressman faces is meeting with the disease groups who want an earmark for their disease. They don't want to hear generalities. What would you say to them?

Both congressional parties support doubling, but my concern is what happens after the 5 years? What would be the impact of a 2.1 percent ($576 million) increase in FY 2004?

Isn't it true that the increased costs of noncompeting grants were $1.2 billion + $800 million in FY 2002 and FY 2003? Aren't noncompeting increases greater than the total budget increase for FY 2004? Can you assure us that the 2.1 percent ($576 million) increase will be sufficient to enable you to pay commitments in FY 2004? Can you assure us that you won't cut levels or grants in FY 2004?

Representative Wicker:

What is your greatest success story from your 2 years as Acting Director?

I would like to have you write a column for a small newpaper in Mississippi that outlines the many accomplishments of NIH.

Regarding H.R. 717, which I sponsored, could you let me know about NIH plans to implement this? Particularly the Centers of Excellence?

Representative Hoyer:

What will be NIH's payline for FY 2003? What will be the lowest IC paylines?

As a sponsor of the Clinical Research Enhancement Act (CREA), can you tell me when NIH will move forward to implement this? In particular, what is the status of the Graduate Training in Clinical Investigation Award? There is a concern of the advocates as to whether the one IC (NCRR) will be able to accomplish all the objectives of CREA.

Representative Miller:

I understand that a new NIH Director has not yet been officially nominated but is expected soon. How long will it take until the individual is confirmed?

Do the IC Directors require confirmation as well? What about the NCI Director?

For a long time the focus for NIH has been on basic research. Now it appears that there has been a shift to clinical research. Has there been a shift in emphasis from basic to clinical research? Percentage-wise, can you define NIH funding by these criteria?

Can you give us an update on stem cell research? How many lines are now available? Are we behind schedule in funding this research?

With regard to earmarks, I have the same concerns as Mr. Cunningham. When an Administration has an earmark for cancer research, it makes it difficult for us to oppose earmarks of our own. Comment?

About the geographic spread of the dollars from NIH, my colleague Mr. Wicker makes a case for Mississippi. Are there any programs to bring states up? How are you addressing this issue?

There is broad congressional support for NIH, but it shouldn't have mandated programs.

This new Clinical Center, is there money in the budget for this? What about the costs? The timeline? Will these problems delay the completion? What is the estimated completion date?

Representative Cunningham:

I wanted to reiterate my wish to hold a town meeting in Washington, D.C., and at UCSD on prostate cancer with Dr. von Eschenbach, and he has agreed to do this.

I have a dream of having a permanent authority for the Office of Women's Health and also one for men's health. (Last year he clarified that this would be at DHHS, not NIH.)

I would like to hear about NIH research into ocular albinism.

I am a great supporter of cancer research, but I have supported the policy of no earmarks for NIH. I noticed that the President's Budget earmarked funds for cancer research. Can you explain this?

Representative DeLauro:

I want to ask the questions I asked the Secretary at his hearing about recoupment of funds from public/private partnerships like CRADAs. Can the profit from some of these ventures be returned to NIH to then conduct research? I have several long questions about this and will submit them for the record:

How are new drugs developed?

Is there any mechanism to recoup funds?

Would you support an in-depth study of how NIH has supported the development of a specific drug, how much support NIH may have provided, who makes the profit. This could then serve as a baseline for further study that may lead us to ways to stretch the research dollar.

Representative Sherwood:

Regarding diabetes, I understand that despite the epidemic in diabetes, since 1987 NIH support for diabetes research has decreased as a share of the budget. Can you comment on this?

Isn't there a 15-20 lag from the discovery of a treatment or modality until this is included in routine patient care? Isn't that exactly where we are with diabetes? It takes so long to get new information into practice. People don't see the links between behaviors and studies. How do we get information out to the public?

Representative Jackson:

I have a series of questions for the record but several to ask here. I expect to ask the ICs about this issue also. The public law provides comprehensive authority to NCMHD to coordinate all minority health and health disparities research at NIH. The law also calls for the establishment of an advisory council to provide direction and second level scientific review for health disparities research at NIH. Finally, the law provides for the establishment of a comprehensive strategic plan and budget for all minority health and health disparities research at NIH. Under the law, this budget is to be coordinated and approved by the Director of NCMHD. Can you provide an update on the progress?

In the FY 2001 budget there was $2.4 billion identified for health disparities research across NIH, yet none of the $74 million increase by the Director was in the budget for the ORMH, now NCMHD, which has primary responsibility for this. Can you explain this?

I would like a detailed breakdown of the $2.4 billion.

I remember questioning Dr. Varmus (former Director of NIH) regarding the role of advisory councils. I understand that IC Directors usually take the advice of their councils. But when the (ORMH) Advisory Council proposed the Center, that advice was rejected. What is the status of the advisory council for NCMHD?

Prepared by Anne Houser, OD/OLPA, March 26, 2001