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children were enrolled in special child development centers.

1.Q. scores at

age 3 were significantly improved for infants of all birth weights who

received the services.

In contrast, nearly half of the at-risk children who

did not receive the intervention program had I.Q. scores below 85, a level

associated with significant learning problems.

The Institute hopes to

reassess these children at age 6 to ascertain if they have maintained the

gains achieved.

It is intriguing to note that this research reinforces observations made

in the laboratory that fetal mouse nerve cells respond to stimulation by

increasing their connections to other cells. Using a unique apparatus, NICHD

intramural scientists are able to study the effects of electrical impulses on

sensory neurons.

One group of neurons are stimulated while another group are

not.

The stimulated neurons respond with an overall increase in the

efficiency with which nerve impulses are conducted. By contrast, the

efficiency of the unstimulated neurons decreases.

This research enhances our

understanding of the formation of orderly connections between nerve cells

during normal development. Scientists believe that disturbances in these

connections may be related to mental retardation or some forms of mental

illness.

Studies such as this demonstrate the vulnerability of the brain to

disruption of its biochemical and electrical interactions. Tangible evidence

of this is provided by the damaged babies being born to cocaine-dependent

mothers.

It is estimated that as many as 375,000 infants may be affected by

in-utero exposure to illicit drugs in the U.S. each year.

In Fiscal Year

1991, the NICHD will start two projects related to this problem. The

Institute is conducting a comprehensive review of current Information about

the adverse effects of prenatal illicit drug use on fetal health, including

possible long term effects, and, through its network of neonatal intensive

care units, is leading a study involving several agencies to assess the impact

of prenatal drug use on the development of the fetus's central nervous system.

Infants in this study will be followed from birth until they enter school to

monitor their progress.

In another longitudinal study involving children, NICHD-supported

scientists at 10 centers around the country are assessing the effects of day

care on social, emotional, and intellectual development. Since approximately

three-fourths of u.s. children under the age of two whose mothers are employed

are cared for by someone other than a parent, it is important to ascertain the long-term effects of different types of day-care situations on children and

their families.

At least 1,200 children will be monitored at regular

intervals from the time they are one month old through age three.

Science is in the very earliest moments of being able to apply what has

been learned about genes and their control to the amelioration or prevention

of disease or disability. Researchers supported by the NICHD recently

developed a mouse model for sickle cell anemia, an incurable genetic disorder

afflicting about 50,000 black Americans.

The availability of an animal model

should prove valuable for testing new drugs and gene therapies to treat the

disease.

To facilitate access to this new technology, the NICHD has established a

National Transgenic Development Facility for the generation of "custom made"

mice.

This facility will make the technology of gene transfer more accessible

to the basic research community at an affordable price.

It is anticipated

that as many as 100 animal models a year will be developed at this facility,

accelerating research on many genetic disorders.

Just as basic research is beginning to yield results in gene therapy, it

is paying off in other areas as well. Recently, the Food and Drug

Administration licensed the first vaccine effective in infants against

Haemophilus influenzae type b. This vaccine is based upon the work of NICHD

Intramural scientists.

This vaccine, once it is widely used, should nearly

eliminate H. flu meningitis as a cause of mental retardation and deafness.

Other vaccines are being developed against pertussis; salmonella;

streptococcus Group B, associated with sepsis in the newborn; Shigella

dysenteriae, the cause of epidemic diarrhea; and Staphylococcus aureus, often

the source of life-threatening infection in burn patients and premature

babies.

The number of women and children with HIV infection is increasing.

Approximately 6,000 HIV-infected women gave birth last year, and about one out

of three of these babies will be infected. NICHD-supported investigators have

found that monthly administration of Intravenous immunoglobulin, a solution

that contains concentrated antibodies, significantly reduces the number of

serious bacterial infections, reduces the number of hospitalizations required,

and prolongs by, as much as a year the time free from serious bacterial

infections in children who are afflicted with symptoms of HIV infection.

The

results of this clinical trial were so compelling, it was terminated a year

early so that the benefit of its findings could be made available immediately

to all symptomatic HIV infected children.

In a joint effort with the National Institute of Allergy and Infectious

Diseases, we are enrolling children with AIDS in other clinical trials, and

beginning clinical trials in pregnancy to attempt to reduce transmission of

the virus from mother to fetus.

Women's health has been a long-standing priority area of the NICHD,

but

the recent increase of HIV infection among women; the small but troubling

upturn in the number of births to unmarried women, primarily teenagers; and

the number of women encountering difficulties in achieving pregnancy have

provided impetus for increased emphasis in this area.

The NICHD intramural

research program plans to expand significantly its research in gynecology to

investigate hormonal, immunologic, genetic, and anatomic processes which lead

to illness or infertility.

In addition, the NICHD plans to fund several new

centers over the next year.

At least one center will focus on infertility

research and as many as three will concentrate on contraceptive development.

Millions of Americans are encumbered by physical disability resulting from

injuries or diseases.

Helping these individuals regain their physical or

functional ability to the fullest extent possible is consistent with the

Institute's interest in human development and the maximization of potential.

To help achieve this objective, a National Center for Medical Rehabilitation

Research has been established within the NICHD.

The new Center will conduct

and coordinate research and research training related to the rehabilitation of

individuals with physical disabilities resulting from problems such as

arthritis, head or spinal cord injury, stroke, burns, birth defects, cerebral

palsy, or genetic disorders.

This first year of a new decade has set the tone for the years ahead--the

Institute has seen the maturation and fruition of research efforts of past

years result in the availability of new products such as vaccines; the

Institute has diligently persisted in attacking and making progress against

problems such as infant mortality that are resistant to quick cures; and the

Institute has maintained its vitality by embarking upon several new

initiatives such as medical rehabilitation.

Mr. Chairman, the FY 1992 budget request for the National Institute of

Child Health and Human Development is $520,584,000. I will be pleased to

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GAMMA GLOBULIN

Senator HARKIN. Dr. Alexander, thank you very much.

As you know, this is an area of intense interest to me not only because of this subcommittee, but I chair another subcommittee on nutrition and also in the Labor Committee on disability which often occurs in young children because of low birth weight and attendant causes with birth.

I was pleased to learn that the Institute found results of the treatment with gamma globulin on pediatric AIDS so promising.

Dr. ALEXANDER. Yes.
Senator HARKIN. And I understand that you got this out early.

Dr. ALEXANDER. We did, within 1 week of the time that the data safety and monitoring committee reviewed the data and indicated that the time had come to stop the trial because the results were significant and should be communicated promptly. We had the results out to the public as well as to practicing physicians,

including agreement thanks to the NIH conference that Dr. Raub had helped to put together-with the New England Journal of Medicine that our early release of the information would not jeopardize publication of the results.

Senator HARKIN. I appreciate that. Thank you, and please keep up that good work. Dr. ALEXANDER. Thank you.

Senator HARKIN. On infant mortality, again I am being asked to shift moneys around for studies.

On infant mortality, as you pointed out in your statement, in black women, the incidence of low birthweight is twice as much as in white women. And you want to set up a study to determine why. Well, isn't it obvious that black women, let's say, lack adequate health care, access to health care? Their nutrition is bad. Their diets are bad. They may have a higher incidence of smoking and alcohol consumption, drug consumption because of their socioeconomic status. It has been my understanding that under the maternal and child health care program through years of study and work in that area that if a woman from month 1 through month 9 has proper nutrition, proper diet, cuts down on alcohol, cuts down on smoking, that the probability of having a low birth weight baby approaches zero.

Dr. ALEXANDER. It does not get quite that good. Even applying what we know, we are not able to reduce low birthweight to that extent. All the statements that you make are correct, and all those factors contribute to a higher incidence of low birthweight, whether in a minority population or in a nonminority population.

If you look at black women versus white women, in the same socioeconomic status, who are college graduates, who are in the optimal childbearing years of age, comparable income, comparable time of prenatal care, diet, whatever else, black women still have twice the incidence of low birth weight as white women. We do not know why that is. We have several studies underway which are trying to get an answer to that.

One is following graduates of minority medical schools over several generations to determine whether higher socioeconomic status

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