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Are three positions really adequate for the Office on Women's Health to make a difference?

Answer. The Office of Research on Women's Health is a new and evolving office within the Office of the Director, NIH. A national search is ongoing for a permanent Associate Director which is an SES position. In addition, a second senior staff level position will be filled in the very near future. The office has also hired another senior level expert and a secretary. I expect that the ambitious goals and planned activities of the office will make it an enterprise whose needs will have to be reassessed as we progress. In this initial stage, we will make effective use of the resources provided in the President's Budget in carrying out the important mission of this new office.

CLINICAL CENTER RENOVATION

Question. Doctor, your FY 1992 budget includes a request for $13.4 million to begin Phase I of a major renovation of the Clinical Center expected to cost over $800 million. Since 1979, and through your 1992 request, $69 million has been either funded or requested for clinical Center modernization.

Why do we need this major renovation now? I thought we were keeping up with the Center's modernization needs.

Answer. This major renovation must proceed to avoid failures of major infrastructure systems that serve large areas of the clinical Center Complex.

The Clinical Center Modernization program, when conceived, was intended to modernize the architectural and functional characteristics of patient care and patient support areas. The requirement of maintaining normal operations in areas not being renovated precluded taking infrastructure systems out of service. Therefore, the modernization program has not accomplished the major improvements to the utilities infrastructure that are necessary to maintain reliable service and to keep pace with added utility loads necessary for modern research.

A comprehensive utility assessment of the clinical Center Complex was initiated in 1988 after preliminary surveys indicated serious problems within the building's utility systems. The final assessment, completed by an independent architectural/engineering firm in 1989, indicated that significant and widespread deficiencies existed in the facility's infrastructure and that major construction was required to correct those deficiencies. As a result of this assessment, the clinical Center Complex Infrastructure Modernization and Improvement Program was initiated.

Because of the very broad scale renovations that will be done under the infrastructure modernization, the current program has been redirected to address the most pressing safety and utility system problems until the new program can accomplish the needed major improvements.

MOUSE PRODUCTION FACILITY

Question. Earlier this year, I wrote you to request that you narrow the competition for the mouse production facility funds just to animal production facilities and laboratory facilities to make this competition more consistent with our original request to you in the FY 1991 Senate report.

What is the status of this competition?

Answer. On March 15, NIH issued a single solicitation for : competitive applications for construction of a large-scale mouse production and mutant characterization facility. There will be full peer review as required by statute; applicants may request up to 75 percent of the allowable costs of a requested project, not to exceed $10 million. We anticipate making an award prior to the end of September.

OFFICE OF MINORITY PROGRAMS

Question. I am pleased to hear that your new Associate Director for Minority Programs, Dr. John Ruffin, recently assembled a team of experts to do some fact-finding on minority recruitment in the biomedical field and to hear firsthand some of the minority community's health concerns.

What is the status of the Office of Minority Program's 4-year Comprehensive Plan?

Answer. The Office of Minority Programs will soon submit to the Congressional Appropriations Committees a preliminary report outlining its strategy for developing a 4-year comprehensive plan to strengthen NIH's minority health research and training activities. This report describes the current activities in this area supported by the Institutes, Centers and Divisions, as well as several activities now being undertaken or planned by the Office of Minority Programs.

One major activity now being undertaken by the office is to convene a fact-finding team that will review NIH's current activities in the area of minority research and training and make recommendations as to how these activities can be strengthened. The recommendations of the fact-finding team will form the basis for the 4-year plan. The fact-finding team is expected to complete its work by the end of fiscal year 1991.

Question. Last year, the Committee urged NIH to develop a comprehensive plan to increase the number of Native Americans in the behavioral and biomedical fields. Will the Office of Minority Programs be taking the lead in this area?

Answer. The Office of Minority Programs serves as the focal point for coordinating the development of NIH policies, goals and objectives related to minority research and research training programs. Its mission includes developing strategies to strengthen NIH's efforts to increase the number of minorities, including Native Americans, working in the biomedical research fields.

The office is in the process of developing a four-year plan to increase research and training activities directed toward all minority groups. A fact-finding team will soon be convened to assist in drafting this plan. This team will be ethnically diverse and include representatives from academia, industry, and national and community based organizations interested in minority health.

Because of the comprehensive nature of this approach, we do not believe a separate Task Force for Native Americans is necessary. However, because of the extent of underrepresentation of Native Americans in the sciences, NIH plans to develop unique strategies specifically designed for this population. We plan to constitute a working group within the fact-finding team that will focus specifically on Native American health and training issues. Several Native Americans are expected to serve on the fact-finding team.

This approach would maintain the inclusiveness of the factfinding effort, but still enable the targeting of a particular group or problem for special attention. The fact-finding team is expected to complete its work by the end of fiscal year 1991.

DIAGNOSTIC RADIOLOGY RESEARCH PROGRAM

Question. In FY 1990, the Committee provided $2 million to enable the Office of the Director to establish a free-standing intramural research program on diagnostic radiologic imaging. Last year, we were pleased to learn during our hearings that laboratory staff were being selected and some equipment were assembled. What is the current status of the intramural program?

Answer. We have made significant progress during the past year in our efforts to establish a Diagnostic Radiology Research Program. The Radiology Research Training program has been organized, and included the participation of radiology research labs from a variety of different intramural Institute programs. In response to advertisement of the Training Program, a large number of applications were received and evaluated. As a result, in July 1991, the first class of radiology fellows will arrive for research training in the program. In support of the program, an image analysis system is being acquired that will provide a centralized basis for the storage and analysis of radiological imaging data. This will also function as a powerful research tool for novel approaches to the interpretation of imaging data derived by different techniques, such as the superimposition of MRI and PET data. Finally, following an active advertising and recruitment effort, a large number of candidates have been screened for the position of Director of the Diagnostic Radiology Research Program. The final selection process is underway. It is anticipated a Director will be selected within the next few months.

Question. How has the Institute capitalized on the most promising areas of research?

Answer. A large variety of new techniques and new ideas has arisen just in the last few years, and a large number of scientists at NIH are utilizing these techniques and developing these ideas.

The use of somatic cell gene therapy by Drs. French Anderson, Michael Blaese and Steven Rosenberg, for the treatment of adenosine deaminase deficiency is clearly the development and use for the first time of techniques for this kind of genetic therapy. It is too early to claim any definite results but preliminary indications are that the children with adenosine deaminase are doing better with the treatment than prior to it. The use of lac cells to deliver potent toxins to tumors is at a very early stage, but clearly this represents a significant clinical application of ideas and techniques that have been generated in the last ten years.

The development of prototypic vaccines for vaccination to prevent AIDS has proceeded rapidly. In particular, clinical trials are beginning on the use of the vaccinia virus to carry important genetic elements, not only of the HIV virus, but of other infectious agents. This represents a culmination of the work of NIH scientists, but principally of Dr. Bernard Moss who, over the last 15 years, has studied the use of vaccinia virus for a variety of vaccinations.

In other related work, early methods of using antibodies and other cellular proteins that will deliver toxins directly, and almost uniquely, to the tumor cells, has been progressing and several of these preparations are in beginning clinical trials. This represents the use of the most recent techniques in recombinant DNA methodology and in toxín production, a major clinical problem.

In yet another field, magnetic resonance imaging, the NIH has one of the premier installations of its kind for this purpose. It should be noted that the history of magnetic resonance research, which started out as nuclear magnetic resonance, began more than 30 years ago in the laboratories of NIH. Without this background, it would have been difficult for the NIH to develop clinical magnetic resonance imaging as rapidly as it has.

Most recently, with respect to spectroscopic magnetic resonance imaging, the NIH has been at the forefront. Dr. Robert Balaban and colleagues have made fundamental contributions to our knowledge of how energy transport is regulated in the mitochondria. Installation of a new large bore high field magnet is planned within the next six months.

HUMAN GENE THERAPY

Question. I was pleased to hear about initial success Drs. Anderson and Blaese have had in using gene therapy to treat Severe Combined Immune Deficiency (SCID).

As I understand it, NIH usually pays for drugs taken by patients in clinical protocols. However, I'm troubled by reports that NIH may not treat the 10 other children suffering from SCID due to the expense of PEG-ADA, the drug that must be administered in conjunction with gene therapy. It will take two years to treat all SCID children, and the annual cost of the drug is $200,000 per child, for an additional cost of $2 million.

will the Director's discretionary fund be used to purchase the necessary amount of PEG-ADA so that the therapy is available to these children?

Answer. It is true that NIH usually pays for the therapeutic agent taken by patients who are part of an approved experimental clinical protocol. That is, the cost for the research protocol is born by NIH. However, NIH does not reimburse for normally prescribed treatment that is not research, and therefore, not part of the approved experimental protocol.

In the case of the SCID patients, PEG-ADA is the normally prescribed treatment, and these patients are prescribed PEG-ADA whether or not they are accepted into the gene-therapy protocol. With regard to the acceptance of SCID patients for the gene-therapy protocol, PEG-ADA is already prescribed in all these patients, and is not a variable under study in the approved protocol.

The approved protocol for gene-therapy requires that SCID patients meet certain medical and scientific criteria to be eligible for the protocol. For example, the patient's cells must be transducable; that is, the gene therapy must "fit" the cells. In addition, the patients must be able to meet certain physical requirements, including the ability to visit NIH every two weeks for treatment. It is intended that all patients that meet the medical and scientific criteria of the protocol will be entered into the study. Therefore, the NIH's ability to pay for PEG-ADA is not a factor in admitting patients into the gene-therapy protocol.

QUESTIONS SUBMITTTED BY SENATOR HARRY REID

NEUROLOGY RESEARCH

Question. What evidence is there that this experiment is instrumental in the advancement of treatment and cures of diseases which relate to human or non-human animals?

(Background information - In justifying his
experimentation, Charles Larson states that "It is
important to study the neural control of vocalization
in order to understand the human speech production
process itself and to learn how neurological
disorders such as Huntington's disease, Parkinsonism,
and spastic dysphonia affect vocalization." However,
experts in the fields of neurobiology, clinical
neurology, primate communication, and other fields in
human and veterinary medicine have provided
substantial evaluations to the contrary. These ·
evaluations conclude that, at best Professor Larson's
grant is a waste of tax monies and, at worst, comes
very close to scientific misfeasance. Considering
the obvious exaggeration and the questionability of
the project goals which allude to these specific
human diseases, by what criteria has the National
Institutes of Health (NIH) funded Professor Larson's
project?

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