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the problems of abortion before they occur, that is minimal, you know. Those thoughts are probably not the first time that I have expressed them; maybe they are, for this record.

Can you give it to us directly, without having to go through that screening process? Let me ask you-give it to us. You have been ordered by a committee of Congress—with great reluctance, because I am normally an easy guy to get along with

Dr. CORFMAN. I am primarily concerned with a scientific program, so you are dealing with formalities that I shall have to check out. But Í certainly know that I have the obligation to respond to a direct order.

POPULATION RESEARCH-PROFESSIONAL JUDGMENT BUDGET FOR FISCAL YEAR 1976: THE CENTER FOR

POPULATION RESEARCH AT NICHD, GRANTS AND CONTRACTS

SUMMARY TABLE

[In millions of dollars)

Fiscal year

Fiscal year 1975 estimate 1976 proposed

Activity

18.3

6.6
(1.5)
(1.2)

(.3)
(5.1)
(1.9)
(.8)
(1.3)
(1.1)

(4.0)

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1. Fundamental biomedical research (grants).
2. Contraceptive development (contracts).
A. Directed laboratory research.

(1) Female.

(2) Male
B. Product development

(1) Synthesis and screening of new drugs.
(2) Drug delivery systems..
(3) Clinical trials of drugs
(4) Development and evaluation of new devices.
(5) Clinical trials of devices.

(6) Natural family planning3. Contraceptive evaluation (contracts)..

A. Oral contraceptives.
B. Vasectomy.
C. IUD's.
D. Abortion

E. Medical benefits of contraception..
4. Fundamental social science research (grants).
5. Directed social science research (contracts).

A. Fertility trends.
B. Determinants of fertility.
C. Consequences of population change to society and families.
D. Population distribution and migration.
E. Teenage illegitimacy.
F. Contraceptive practices..
G. Economic consequences of population change.

H. Environmental consequences of population change 6. Institutional and manpower development.

A. Population centers (grants).
B. Research training (grants).
C. Scientific information and staff support..

Total budget..

25.0 14.5 (2.5) (1.5) (1.0) (12.0] (1.0) (3.0) (2.0) (1.0) (1.0)

9.0 (5.0) (1.5 11.01 1.0) 1.5 7.0 9.5 (1.5) (2.01 (1.5 11.01 (1.0)

1,5 11.0 11.0) 19.0 (6.0) (6.0) 17.0)

4.4
3.3

1.9]
(1.0)
1.8

10. 2
(4.0)
13.5)
12.7)

47.6

84.0

POPULATION RESEARCH: A PROFESSIONAL JUDGMENT BUDGET FOR

FISCAL YEAR 1976 In his Health Message of 1968, President Johnson directed the establishment of the Center for Population Research at NIH “* * * to give new energy to (population) research activities of all Federal department and agencies in the field.” He identified as fields for study the physiology of reproduction and its effect on all aspects of human life * * *" and "* * * searching studies *** to determine the complex emotional, sociological, psychological, and economic factors involved * * *”? In his Population Message of 1970 President Nixon charged the Center to promote research on "* * * birth control methods of all kinds * * *” and “* *'* the sociology of population growth.”

Following such initiatives, the Center's budget grew from $8.9 million in fiscal year 1968 to $47.9 million in fiscal year 1974 with little change in fiscal year 1975. The President's budget for fiscal year 1976 projects a decrease to $38.7 million.

This professional judgment budget for fiscal year 1976 is based on a realistic evaluation of the capabilities of NIII staff, scientific prospects, and the ability of American scientists to respond to a research field of social importance. The estimates are drawn from our working knowledge of the fields and consultation with an array of competent advisors. We are certain we could carry out the program proposed with responsible stewardship of public funds with the condition that Center staff be increased from 37 to 60.

The Center's goals in the biomedical sciences are (1) to increase our understanding of all aspects of human and relevant animal reproductive processes in both the female and male; (2) to develop an array of contraceptive methods which are effective, safe, inexpensive, reversible, and acceptable to various population groups; and (3) to evaluate the medical effects of contraceptive methods in use to assure safety and efficacy over short as well as extended periods of time.

Our research objectives in the social sciences are (1) to ascertain the social, psychological, and economic determinants of fertility, since fertility is the single most dynamic factor in population growth; (2) to assess the effects of population size, composition, and distribution so that public policy may be guided by adequate information; (3) to identify the conditions which precipitate migration and to define its consequences, since migration is one of the principal means by which populations adjust to social and economic change; and (4) to increase our understanding of the economic, environmental, social and behavioral consequences of population growth and change.

In order to provide insight into our range of activities, we list here some of our recent findings in population research. These examples are taken from over 700 individual projects now underway and demonstrate the relevancy of our program to population problems in the United States.

1. The production of sperm is controlled by the two male sex hormones, testosterone and follicle stimulating hormones (FSH). Testosterone stimulates sperm production directly and is aided by FSH which causes the production of protein (Androgen Binding Protein-ABP) which carries the testosterone to those parts of the testis where sperm are produced. This new information suggests some specific possibilities for the development of male contraceptives.

2. The structure of the hypothalamic hormone which initiates the release of other hormones responsible for ovulation has been identified. This hormone has been synthesized in the laboratory and is being used extensively as a diagnostic and therapeutic agent in a variety of reproductive disorders.

3. Chemical antagonists of the hypothalamic hormone mentioned above, have been synthesized. Recent experiments in animals indicate that injection of such antagonists can reduce the level of the hormone responsible for ovulation and thus block the release of ova. This may be a lead toward the development of a highly specific and therefore safer and more effective contraceptive.

4. New biodegradable and biocompatible polymers have been developed which can prolong drug activity for extended periods of time, such as 6-12 months. These drug-polymer combinations release small amounts of a drug on a continual basis when injected or implanted in the body. This advance in the method of administering drugs can lessen the amount of a drug to which the body is exposed and thus reduce the incidence of undesirable side effects. The polymers therefore may be important in the development of new long term injectable contraceptives for both men and women.

5. A recently completed case-control of thromboembolism confirms that the risk of this complication decreases with a decrease in the estrogen dose of the pill preparation used.

6. Studies of women on oral contraceptives have shown a decrease in gammaglobulin levels. These data may be related to other studies which suggest that oral contraceptive users appear to be more susceptible to infections, particularly viral infections.

7. There was a several-fold increase in incidence of hypertension among the women on oral contraceptives. Also abnormalities in the metabolism of carbohydrates and lipids have also been noted among the oral contraceptive users.

8. A study dealing with female employment and fertility has found that women's labor force activity influences their fertility behavior. Furthermore, both work and fertility goals appear to be formed relatively early in life.

9. There is a continuing trend toward the two-child family, a significant change from the situation ten years ago when the average number of children was three. At the same time, very few couples expect to remain childless, so that it does not appear that we are returning to the widespread prevalence of childlessness observed in the 1930's.

10. A study concerned with the consequences of family size indicates that the decline in average family size, particularly the proportion of couples with large numbers of children, will have a beneficial effect on child development. The study showed that family size is inversely related to student aptitude, achievements, interests, activities, educational and occupational expectations, attitudes, social life, and work habits. Children from smaller families, regardless of socioeconomic level, score higher in aptitude measures, have a higher academic potential, expect to have smaller families and tend to marry later. Female children appear to be more adversely affected by larger family size than males.

The professional budget described below is for the Center for Population Research which directs a national program in grants and contracts. ur grants are used for research fundamental to all the population sciences and for institutional development and training. Contracts support the procurement of specified scientific data and materials, such as new contraceptive drugs and devices.

We do not describe here in-house laboratory research conducted on the NIH campus nor do we elaborate on the important relationship between the Center for Population Research and the newly established Center for Research for Mothers and Children. Both Centers are part of the National Institute of Child Health and Human Development.

Fiscal year

1975 estimate

Fiscal year

1976 proposed

1. Fundamental biomedical research..

18.3

25

This activity is the Center's oldest and largest program. It supports the vast majority of fundamental laboratory work upon which new developments in contraception, genetics, and other applied topics depend. Noteworthy have been significant increases in studies of male reproduction, in our understanding of the control of the brain over reproduction, and in how sex hormones work. These activities fulfill our need to develop a science base for finding solutions to population problems as they change with time. The increase proposed is modest in relation to the demand. For several years we have been unable to fund a substantial number of scientifically qualified projects.

Fiscal year

1975 estimate

Fiscal year

1976 proposed

2. Contraceptive development (contracts). A. Directed laboratory research..

(1) Female

(2) Male.
B. Product development..

(1) Synthesis and screening or new drugs.
(2) Drug delivery systems..
(3) Clinical trials of drugs.
(4) Development and evaluation of new devices.
(5) Clinical trials of devices.
(6) Natural family planning.

6.6
[1.5)
(1.2)
(13)
15.1]
(1.9)
(8)
(1.3)
(1.1)

14,5

12.5] (1.5) (1.0) [12.01 (4.0) (1.0) (3.0) (2.0) (1.0) (1.0)

Our mandate to develop new contraceptives for men and women has been underway at NIH since the Center was established in 1968. Product development started in 1971 when we had a staff competent to conduct this highly technical program.

Directed Laboratory Research supports fundamental research which is specified by us to be potentially important to the development of new contraceptives. Increased attention has been given to males and recent work suggests promising leads in this area. We propose to increase this work and work on female reproduction to some extent.

Significant increases are proposed for Product Development. They involve a wide range of activity, including the development and clinical trials of drugs and devices as well as a new program to evaluate natural family planning. We have the authority and scientific capability to manage such a full range of activities but are restrained by lack of funds and staff. Particular attention should be given to clinical trials of drugs and devices, which are expensive and require close staff supervision.

Also, we have long wished to improve methods of natural family planning, but have been restrained by the lack of significant scientific prospects and limitation of funds. Recently new techniques for natural family planning have been described which should be evaluated. Such an evaluation would cost approximately $1 million a year for three or four years. We know that such an improved form of rhythm would be attractive to many Catholics and non-Catholics alike.

Fiscal year

1975 estimate

Fiscal year

1976 proposed

3. Contraceptive evaluation..

A. Oral contraceptives
B. Vasectomy.
C. IUD'S
D. Abortion.
E. Medical benefits of contraception.

4.8
(3.8)
(.9)
(.1)

9.0 (5.0) (1.5) (1.0) (1.0) (.5)

This was the first contract activity of the Center for Population Research and Development began with the study of oral contraceptives. Such studies continue and should be expanded. We have particular interest in the possible relationship between the use of oral contraceptives and the effects on subsequent pregnancies. Also, there is a need to confirm foreign data which suggest that there may be a positive relationship between oral contraceptives and myocardial infraction. It's reassuring to note, however, that our studies have shown that there appears to be no relationship between the pill use and breast cancer.

The vasectomy projects are designed to find out as rapidly as possible if this technique is safe. Within recent years concerns have been raised about possible side effects and since this is an increasingly popular method of contraception our strategy is to make a determination concerning safety as rapidly as possible.

We wish to expand this program into three new areas of research: the evaluation of intrauterine devices, an examination of the possibly harmful effects of abortion on women and on subsequent pregnancies, and an analysis of the positive effects of contraception on women and their families.

Fiscal year

1975 estimate

Fiscal year

1976 proposed

4. Fundamental social science research.
5. Directed social science research.

A. Fertility trends
B. Determinants of fertility
C. Consequences of population change to society and families.
D. Population distribution and migration..
E. Teenage illegitimacy-
F. Contraceptive practices.
G. Economic consequences population change
H. Environmental consequences of population change..

4.4 3.3

(.9) (1.9) (.8) (.1) (.4)

7.0 9.5 (1.5) (2.0) (1.5) (1.0) (1.0) (.5) (1.0) (1.0)

Our social science research is relatively new, having started when the Center was established. The social science budget then was $1 million and it is now $7.7 million.

The Fundamental Research program exists to provide a scientific base for the development of social policy and goal-oriented research. A relatively modest increase is proposed.

The Directed Research program is an integral part of the mission of CPR and has three essential concerns: the determinants, consequences, and processes of population change. All are developed to provide a scientific foundation for the development of population policies, and to provide citizens with information on which to make intelligent decisions.

The plan for 1976 includes an expansion of the current program and the development of several new areas. Of particular importance is the study of teenage illegitimacy, a social problem of constantly increasing concern. Also proposed are new programs in the economic and environmental consequences of population change. These areas have not yet been systematically studied and we believe that it is important and timely to begin such investigations.

Fiscal year

1975 estimate

Fiscal year

1976 proposed

19

6. Institutional and manpower development..

A. Population centers.
B. Research training-
C. Scientific information and statt support...

10.2
(4.0)
(3.5)
(2.7)

In 1972 the CPR established a Population Centers program, designed to develop an array of institutions devoted to all aspects of population research. We now support 12 such centers and propose that the number be gradually increased to 20. Taken in aggregate, this is a productive, and efficient operation, which is national in scope.

The training programs are used for institutional training grants and individual fellowships. We maintain that there is a continuing and growing need for qualified population scientists.

Senator Bayh. You just got an order.

Really, the reason I want to pursue this is that I am not unaware of the pressures. I suppose this is not the first time those pressures have been existent-the chain of command and all that business. I want to put it right on the line; we want that information.

We were talking with Dr. Schmidt yesterday about the whole problem of DES. We were informed there is a bill now moving that would prohibit the use of DES in cattle feed. The FDA, on the other side of the table, was saying, we testified that was not the right approach. There should be another approach to give us the opportunity to deal not only with DES but the other series of estrogen that can replace DES and other drugs before they get to the market without going through all the redtape. I said, have you ever made a specific suggestion like that to the committee or to Congress. Their answer was "No." I asked why; they said, because we were not asked. Apparently they had made the suggestion through channels, but somehow or other the channels got blocked. It must have been a pill obstructing the flow from one place to the other.

Well, thank you, doctors. I appreciate your lending your expertise to this very sensitive and important area.

The subcommittee stands adjourned.

[Whereupon, at 11:50 a.m., the subcommittee adjourned, to reconvene subject to the call of the Chair.]

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