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Senator HATFIELD. And you are still, Dr. Raub, the Acting Direc


Dr. RAUB. That's correct, Senator.

Senator HARKIN. In March 1991.

Would you fill in the gap for me of what has occurred, or not occurred, between then and now?

Dr. RAUB. Soon after the time that Dr. Wyngaarden indicated his plans to leave his position-and that was in the spring of 1989— the Department of Health and Human Services formed a search committee headed by the Assistant Secretary for Health that began immediately to identify potential, high-quality individuals for the position. Typically, the search committee not only received information on those who volunteered their interest, but also actively sought out individuals they hoped would be interested in the position. I was not a member of the committee. Another senior member of the NIH staff was. I have no direct information as to its deliberations.

I do know that over a period of months up to and following Dr. Wyngaarden's departure, the search committee attempted to identify highly qualified candidates interested in the position. For one reason or another, several individuals indicated that this was not the position for them. They could not afford the salary reduction that would be involved, were not interested in Government service at this time in their lives, and so on. It remained that way until Dr. Bernadine Healy was identified and indicated her interest in the position. Confirmation action is now proceeding.

Senator HATFIELD. I believe simultaneously, as we meet here, that the confirmation hearing for the permanent Director is being held at this time. Is that correct?

Dr. RAUB. That's correct, as we speak.

Senator HATFIELD. Mr. Chairman, I have used an unusual procedure this morning in making my opening remarks by posing a question to make a point in saying to Dr. Raub I welcome him to this subcommittee hearing, a man of extraordinary talent for having been able to hold together an institution that is more of a confederation than a federation anyway, 13 separate competing Institutes all most worthy of greater funding, under the authority of an Acting Director. I think it is an extraordinary example of leadership, and I commend Dr. Raub.

I think it is very unfortunate for the institution that there has been this inordinate delay between the time that notice was made public, pre-July of 1989, by Dr. Wyngaarden and the fact that it took until today to get to the hearing stage of finding and establishing a successor.

You are neither fish nor fowl in that role of Acting Director. You have to keep the ship afloat. You have to make projections for the future. And it is hard for people to take you seriously in many ways because they say, well, Dr. Raub is not going to be here to fulfill or implement these policies or changes that are occurring or should occur. I just think it is a remarkable demonstration of leadership, and I wanted to take this occasion to thank you and to say to you that we owe you, indeed, a great debt of gratitude.

And again, whether it is the process, or whether it is the appointing activity, or whether it is the confirmation activity, we all

must take some responsibility for this unconscionable delay in getting a permanent head to one of the most important agencies this government sponsors. And in spite of this delay, you have launched a science education program, to create greater interest in the math/ science field for young students coming along and for renewing the interest of teachers of math/science, a dual purpose. And I want to commend you for that.

I, like so many of us, all of us for that matter, have several subcommittees meeting today at this particular hour beginning at 9:30, and I am going to try to at least put in an appearance at a number of them. So, if you would excuse me, Mr. Chairman.

I do have some questions concerning sleep disorders and a few other things that are of interest to all of us.

But I just wanted to take the opening statement format of this subcommittee to make this tribute to a very, very phenomenal leader.

Dr. RAUB. Thank you, Senator.

Senator HARKIN. I would like to associate myself with those comments also, Dr. Raub. And again, my high esteem and my thanks for all that you have done at ÑIH over the last couple of years.

Senator HATFIELD. May I add one P.S.?

Senator HARKIN. Yes.

Senator HATFIELD. And to the leader of each of those 13 Institutes I commend you, because Dr. Raub could not have done it by himself. And so, all of you ladies and gentlemen, and others who represent the Institute leadership, it is a composite compliment that I want to offer.

Thank you, Mr. Chairman.

Senator HARKIN. Speaking of subcommittee and committee hearings, another committee that I am on right now is meeting upstairs on the confirmation hearing for Ms. Healy right now.

Dr. Raub, again, welcome and your statement will be made a part of the record in its entirety, and please proceed as you so desire.


Dr. RAUB. Thank you, Mr. Chairman. First, I'll introduce the individuals at the table with me. Beginning on my far right, Mr. Dennis Williams, Deputy Assistant Secretary for Budget, Department of Health and Human Services; Dr. Anthony Fauci, in his capacity as the NIH Associate Director for AIDS Research; Dr. Leamon Lee, who is the Director of Financial Management at the NIH; John Mahoney, who is the NIH Associate Director for Administration; and Dr. John Diggs, the newly appointed Deputy Director for Extramural Research.

Mr. Chairman, with your permission I will submit my prepared statement for the record and offer only a few highlights now.


During the past year, the programs of the NIH were particularly productive. Most dramatic were the first two instances of human gene therapy, one involving an inherited disorder of the immune system, one involving the treatment of advanced cancer and both

exhibiting the fruits of an extraordinary partnership among scientists from the National Heart, Lung, and Blood Institute and the National Cancer Institute. This blending of expertise from several disciplines in a stable collaboration over a long period of time illustrates the special strength of the NIH Intramural Program.

Many other outstanding advances in science and in medicine are described in the formal budget justification and in our individual statements for this hearing.

Against this backdrop of achievement, the President is requesting $8,775 million for the NIH for fiscal year 1992, an increase of $498 million over the fiscal year 1991 level. This proposed increment of 6 percent compares favorably to the overall cap for domestic spending that is associated with the deficit reduction agreement between the Congress and the executive branch.

Within the 6-percent increase, the NIH proposes to place special emphasis on the following activities: Research project grants; the NIH Intramural Research Program, especially the refurbishing of its infrastructure to meet the needs and challenges of the new era in biomedicine; the Human Genome Program; and programs to develop minority scientists, improve minority health, and strengthen institutions.

Among these, the proposed budget for research project grants is noteworthy, providing for 5,785 new and competing renewal awards, the same number as this year, and 21,818 total awards. This is the highest level ever proposed, and represents a total investment of almost $5 billion, an increase of 8.8 percent over the fiscal year 1991 level, providing 3 percent real growth above the biomedical research and development price index of 5.8 percent.

Integral to the budget request, especially the portion covering research project grants, is the financial management plan that the NIH developed and is implementing in response to the congressional report language accompanying the fiscal year 1991 appropriations. Our goal is to control costs in such a way as to introduce greater predictability with respect to both the overall funding opportunities from one year to the next and the specific funding levels throughout the life of any particular project. The core idea is to impose explicit constraints on year-to-year growth of the costs of grants in the aggregate, but to rely upon informed judgment of peer reviewers and staff to make grant-by-grant decisions within that ceiling.

Also manifest in the request for fiscal year 1992 are proposals to continue and enlarge upon initiatives launched in fiscal year 1991 through use of a portion of the NIH Director's discretionary fund. These involve women's health research, minority health research, science education at the elementary, secondary, and baccalaureate levels, and research training relevant to rehabilitation and physical medicine.


Mr. Chairman, we approach fiscal year 1992 with a sense of excitement derived from our momentum and the burgeoning research opportunities in almost every area of biomedical science from treatment to prevention. At the same time, we maintain a healthy respect for the complexities of human disease and how much we have

yet to learn. We are committed to giving the American people a substantial return on their generous investments in the NIH.

We will be pleased to respond as best we can to questions that you have.

[The statement follows:]


Mr. Chairman, I am privileged to appear before the Subcommittee to present the President's FY 1992 budget proposal for the National Institutes of Health. I will touch on some significant research advances that have been made during the past year, describe briefly our management plan for funding research grants, and outline the highlights of the FY 1992 budget proposal.

Subsequently, the Directors of the several Institutes, Centers, and Divisions will extend and amplify selected topics from their unique perspectives.


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Enormous progress is being made in molecular genetics, pointing
the way to totally new forms of therapy. Last September a team
of scientists from the National Heart, Lung, and Blood
Institute and the National Cancer Institute initiated the first
clinical trial of human gene therapy by infusing a severely
immunodeficient 4-year-old girl with her own white blood cells
into which a normal adenosine deaminase (ADA) gene had been
inserted. The patient has ADA deficiency disease, an extremely
rare inherited disease that can cause death if untreated.
the latest report the young girl was doing well.


Then, on January 29 this year the same team of NIH scientists
performed the first gene therapy for cancer patients. Two
patients were given transfusions of genetically modified tumor
infiltrating lymphocytes (TIL) removed from their own tumors.
These naturally occurring cancer-killing cells were armed in
the laboratory with a gene capable of producing tumor necrosis
factor (TNF), a potent antitumor toxin. The genetically
altered cancer-killing cells that were returned to the patients
are expected to carry the TNF gene directly to the tumor
site(s), thereby potentially maximizing the gene's benefit and
avoiding the toxicity that could result if TNF were distributed
throughout the body. If TNF is active throughout the body for
too long or at too high a concentration, it can cause shock and
body wasting.

These unparalleled advances also provide excellent examples of the unique ability of the NIH intramural environment to foster sustained collaborative efforts by leading scientists across disciplinary and organizational lines.

O Last year brought a major clinical advance in the treatment of spinal cord injury. A clinical trial supported by grants from the National Institute of Neurological Disorders and Stroke demonstrated the first effective treatment for this devastating problem experienced by about 10,000 Americans each year. When patients in the study were given large doses of the drug methylprednisolone within eight hours of their injury, they regained significantly more motor and sensory function than untreated patients or those who received another drug.

O The NIH continued its aggressive support of laboratory and clinical research directly geared toward developing new treatments and potential vaccines for AIDS. In this connec

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