Senator SCHWEIKER. Where you are dealing with a community in these programs, just what concept or role do you foresee in terms of a mix between the lay person, professional person, and also black groups that probably want to participate, such as the Black Athletes Foundation? What role do you see for these various participatory groups in your setup?

Dr. BECKLES. I think, Mr. Chairman, the way to respond to that, is that the program at the community level has several components. There is the component which in one instance might deal just with public education. There is a component which would deal just with the role of the community voluntary worker, the raising of community funds, and the level of community interest in sustaining this.

The interaction at the level of the clinic of the community, and the patient, depends on the particular setting, but we would hope to be able to create within the clinics screening and testing, which would be carried out. The sensitivity, respect, and dignity reflected in the program would depend on the nature of the community.

Senator SCHWEIKER. When we talk about screening and educational clinics, the 10 or 20 in number you envision under the $1 million phase, are we talking here about utilizing neighborhood clinics, mental health clinics, children and youth projects, child care centers, or public health facilities?

Dr. BECKLES. Senator, there would be a variety of such clinics. I think there exists a variety of facilities now. We will probably not create a new series of clinics across the country, just for sickle cell anemia.

The degree to which the program is therefore placed in an ongoing institution, in an operative institution, depends on the particular nature of the community.

For example, one might have such a screening clinic, which does screening, counseling, and education, and then refers patients to a larger institution, when this is necessary. What we envision is a kind of feeder mechanism, where one establishes, for example, a center, in which is found a range of capabilities that would cover such areas as development of educational materials and the training of manpower, because we are going to need many people here to do this work. This is another role in which the community worker will be hopefully involved, so that this comprehensive center would have all of the services needed in a given community. In certain geographical locations one could have either permanent clinics, to do a part of the work, or temporary facilities such as mobile screening clinics, or a school which can screen, envisioned as a temporary setting, which then feeds back to a more permanent center, depending on the nature of the cases discovered.

Senator SCHWEIKER. Since one of the major problems with this situation is education, what is being done now, or what is planning to be done on the basis of encouraging physicians and nurses, who are in the flow of our medical service delivery systems now, to actually look out for and be aware of this disease?

What are we doing in this area, if anything?

Dr. RINGLER. Mr. Chairman, what we are doing at this point in time is little. What we envision doing is manifold. The National Institute of Mental Health will next week sponsor a conference at the

Meharry University to deal with the problems you have raised in the question of education. This will be a beginning.

How does one work with the physicians, the laymen, the various allied health professions; what are the best ways of working with them; what are the best ways of developing educational materials; and so forth, concentrating here particularly on the technique of counseling. These are the questions to be answered.

The regional medical problems agencies within the Mental Health Administration would provide a network so that when materials are developed, or training is to be offered across the United States, the physicians and other health professionals can come to these or be reached through this mechanism.

Again, it is envisioned that the comprehensive center would work in developing its own materials, and then in collaboration with expert organizations, such as NIH, would perfect the development and use of educatonal materials. There is envisioned a multifaceted approach to the development, the testing, the dissemination, and the evaluation of educational materials.

Senator SCHWEIKER. What about medical schools, knowing that this is the key source of education of future doctors, what do you envision as far as medical school education is concerned?

Dr. RINGLER. We will try to orient physicians who are now practicing. We need also to emphasize this disease phenomenon in the training of medical students.

I dare say it is included, Senator, but not adequately covered in the course of the preparation of medical students. I am quite certain, that with increasing awareness, we could envision working with such organizations as the American Medical Association and the National Medical Association to make sure that the curricula of medical students begin to reflect new knowledge, as it is learned and made available.

Senator SCHWEIKER. There recently appeared an article in the Washington Star describing cutbacks in the National Institute of Mental Health program, which was investigating genetic engineering.

Inasmuch as genetic engineering is a very key part of this whole approach, are we not moving backwards in this area, and what efforts will we make to reverse the cutback of genetic engineering, which has so much to do with this problem?

Dr. ZAPP. I am unaware of that, Senator. We would have to supply that information for the record.

(The information referred to and subsequently supplied, follows:)

NIH PROGRAM ON GENETIC ENGINEERING

NIMH research reported in the October 8 issue of Nature, an eminent British scientific journal, described for the first time a technique involving the use of viruses to transfer genes from bacteria to defective human cells in tissue culture. Tests showed that the genetic material thus transferred apparently corrected the defect in the human cell.

The study has been conducted over the last three years by Dr. Carl R. Merril and Mr. Mark R. Grier of the Laboratory of General and Comparative Biochemistry, NIMH, in association with Dr. John C. Petricciani, Division of Biologics Standards, NIH.

This report of successful functioning of bacterial genes in human cells opened the way for new research in all diseases where heredity is involved. Recognizing the importance of this study and its potential for improving human health,

NIMH gave it top priority. Despite the severe limitations imposed by personnel and budget restrictions (to which the Washington Star article quoted by Senator Schweiker referred), two new staff positions (one's a doctorate level chemist, the other for a tissue culture technician) have been assigned to Dr. Merril. As the design for these studies is developed and further expansion is required, every effort will be made to see that specific needs are met. Such funding from existing resources, however, must come from other programs within the Institute whose benefits, while important, seem destined to develop more slowly. Extensive new initiatives in the field of genetic research will have to be supported through additional appropriations.

Senator SCHWEIKER. All right. That is all I have.

Senator KENNEDY. I want to apologize for not being here during all of your testimony.

I do not want to go over old ground, but I want to get some answers to my own satisfaction, and clearly I would like to clear my own mind on your position.

The administration does not support this legislation, is that correct?

Dr. ZAPP. We feel the legislative authority requested here is unnecessary. We are currently, in response to the initiative of the President in his health message, and also through the new Sickle Cell Disease Advisory Council, working on the same objectives as the bill before the committee.

Senator KENNEDY. What did the administration request last year in terms of this program?

Dr. ZAPP. For this current fiscal year, the request was $6 million.
Senator KENNEDY. This year, 1972?

Dr. ZAPP. Yes, for this current fiscal year.

Senator KENNEDY. Will you tell us what your request is in terms of next year?

Dr. ZAPP. We went through that a minute ago. I am unable to say what the request for next year will be. I can only say on the basis of experience, that in the past where initiatives have been singled out like this, they generally continue to receive favorable treatment. It is, in essence, a commitment to this disease as we noted in our statement.

Senator KENNEDY. Have you given us some indication of how you will spend that money, the $6 million; could you give that to us, have you given it to us?

Dr. ZAPP. Yes, in my testimony previously.

Senator KENNEDY. And to go back, we requested how the resources were being extended, the money that has been available previously, and how HEW, NIH has allocated those resources; you will provide that for us?

Dr. ZAPP. Yes.

(The information referred to, subsequently supplied, follows:)

SUMMARY OF NIH-SUPPORTED RESEARCH IN SICKLE CELL DISEASE

NATIONAL HEART AND LUNG INSTITUTE

Through its extramural programs, the NHLI supports investigator-initiated research projects dealing with pathogenesis, prevention, and treatment of sickle cell disease and its complications, particularly those resulting from vaco-occlusive episodes. The research may be fundamental or clinical. The mechanism of support is by research project grant.

The Institute now supports a number of grants with major emphasis on sickle cell disease, at a total current funding level of approximately $450 thousand.

Utilizing funds which were already available, and unrelated to the new initiative, the Blood Resource Branch has awarded approximately $500 thousand in contracts for the support of the first phase of a cooperative study to test the feasibility of clinical trials of therapy for the sickle cell vaso-occlusive crisis. While major emphasis will be on evaluation of urea therapy, other therapeutic regimens will be included.

A contract has also been awarded for studies on the effect of cyanate on the sickling phenomenon, and the in vivo survival of cyanate-treated red blood cells.

NATIONAL INSTITUTE OF ARTHRITIS AND METABOLIC DISEASES

The overall commitment of the National Institute of Arthritis and Metabolic Diseases is to research in those diseases that are of metabolic origin. For the blood and blood-forming organs, this includes basic and clinical studies of a metabolic nature on anemias and hemoglobinopathies, and hemoglobin structure and synthesis. This Institute also supports research on genetically determined diseases when the primary interest is on factors affecting growth, development, and maturation.

A member of the intramural staff of the NIAMD is Dr. Makio Murayama who worked out the detailed spatial configuration of hemoglobin S. In his laboratory at the NIH, he is continuing his fundamental physicochemical studies of the mechanism of sickling, and the effect of urea at varying concentrations on intact sickled erythrocytes. He has also initiated studies on an intracellular co-factor, found in erythrocytes from patients with sickle cell disease, which apparently is essential for polymerization of the hemoglobin S.

Through its extramural programs, the Institute currently supports eleven projects, at a total of approximately $420 thousand, which deal directly with sickle cell hemoglobinopathy. All or a greater part of the activity is concerned with hemoglobin S-its structure, properties and synthesis-and/or observations on, and treatment of patients with sickle cell disease. A second group, of three projects, deals with a number of different aspects of hematology, including a component relating to sickle cell disease. A third group of projects supported by this Institute concerns the search for basic knowledge of the genetic control of protein synthesis which has significant implications in the therapy of all molecular disease.

NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES

The National Institute of General Medical Sciences supports noncategorical health-related research encompassing a broad range of scientific disciplines, and multidisciplinary efforts involving both fundamental biological research and clinical investigation. This Institute is responsible for support of projects that are of significance to more than two of the other Institutes of NIH. One of this Institute's program areas is genetics. The research supported is less disease related, and more oriented toward improved understanding of basic mechanisms involved at the biological level, at the chemical level, and at the molecular level. Significant components of three large multidisciplinary, multicategorical programs in genetics, supported by grants, relate to research on sickle cell disease and hemoglobin S.

One of the component parts of the extramural program is a continuing study by Dr. Harvey Itano of the synthesis of the abnormal sickle cell hemoglobin. Senator KENNEDY. Do I understand correctly, that the Department can do the kind of work that has been suggested in this legislation without enacting new legislation?

Dr. ZAPP. That is right. Our only difference, Senator, is with the necessity for this authorizing legislation. We are currently using a variety of legislative mechanisms within the Department.

Senator KENNEDY. The problem I have seen in the past, for example, with lead-based paint poisoning, when that bill was introduced, the administration said the same thing-that additional legislation

71-519 O - 72-5

wasn't needed. DHEW testified that adequate legislation was already on the books to resolve the problems of lead-based paint poisoning. Although the legislation itself was passed overwhelmingly in the Senate, and in the House, I think we stimulated the administration to take greater action on this issue than would otherwise occur.

I think the same thing is generally true concerning sickle cell anemia. I do not question that you can somehow find the authority. to provide the resources for this kind of health need, but it just is not being done.

Dr. ZAPP. I think this case is probably different from some of the other legislative debates that have taken place on categorical versus comprehensive programs.

This is different since we started in February with a presidential initiative, and we are currently using that authority, as opposed to saying, on the other hand we would use some authority. We are actually in the process. The only thing we have really waited for is getting the recommendations from the new Sickle Cell Disease Advisory Committee.

We have been waiting for them to suggest to us how we should use these funds.

Senator KENNEDY. How should the Congress

Well, do you have the power to do all of the things that are in the legislation?

Dr. ZAPP. Yes.

Senator KENNEDY. And how can Congress indicate its sense of priority on this question, if we just leave this up to the administration? Could we have a role to play in identifying areas of high priority, and should we not respond to that responsibility if we feel very strongly about it, rather than leaving the questions up to the executive branch?

Dr. ZAPP. I most certainly would think so, Senator.

Senator KENNEDY. How would you suggest we indicate or register our sense of deep concern?

Dr. ZAPP. I think there are a variety of mechanisms, other than new legislative authority.

Senator KENNEDY. We have done it in some other areas.

We have been able to do that in efforts to get additional kinds of resources to fund legal services, and nutrition programs, and for lead based paint poisoning. We on this subcommittee believe in the need to try and establish at least the sense of priority for sickle cell anemia. Let me try to find out how strongly you are opposed to this legislation.

Dr. ZAPP. Well, I am not sure that I could categorize the difference in regard to this particular bill.

The departments many times has a variety of existing authorities. An example of this is in community services where there are many current authorities that can be used.

Senator KENNEDY. Do you have any problems in terms of the amounts of the money?

I am not asking you now as a spokesman for the administration, but in terms of the need, the kinds of applications, in terms of the money, could $25 million be used for sickle cell anemia programs?