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affected patients by enhancing normal hemoglobin synthesis with drugs such as hydroxy urea. Thus, for the first time, the underlying Bolecular pathology is being treated, rather than the symptoms of the disease. In addition, the obstacles to gene therapy are being overcome. The realization of this objective will see the developsent of the ultimate cure for sickle cell anemia, as well as other genetic diseases that have been elucidated at the molecular level.

Mr. Stokes: I understand that as a result of activities supported by your institute, methods have been developed which have resulted in the improved care of low birth weight infants.

Will you describe these developments?

Dr. Gorden: Almost all infants weighing less than 1, 200 grams (about 2 pounds, 11 ounces) require intravenous feeding for the first few days or weeks of life. The energy and protein needs during intravenous feeding have been studied by a number of investigators. However, there has been little information regarding the vitamin needs of these infants. Although vitamins have been routinely administered with intravenous feedings, few studies have been done that evaluate the stability of these vitamins in the intravenous solutions or the efficacy of the vitamin dos ages. Methods developed and tested by NIDDK grantees to determine blood and urine concentrations of nutrients in low birth weight infants have provided the first substantive data from which guidelines can be derived for use of vitamins in the intravenous feeding of this population.

Mr. Stokes : What impact will this have on the care of low birth weight infants?

Dr. Gorden: The methods developed by NIDDK grantees to monitor specific levels of nutrients have already led directly to improvebents in patient care. For example, almost one-half of low birth weight infants were found to have a deficiency of vitamin A, despite receiving vitamin A in their feedings. Once aware of the vitamin A deficiency, scientists discovered an 85 percent loss of the vitamin supplement during standard intravenous delivery procedures. Researchers have since succeeded in preventing these losses by changing the method of vitamin A delivery. Consequently, the incidence of bronchopulmonary dysplasia, a chronic lung condition linked to deficiency of vitamin A, has been reduced. The ability to monitor nutritional status should lead to additional improvements in the delivery of nutrients to low birth weight infants.

RESEARCH PROJECT GRANTS

Mr. Early: What is the average increase in the size of noncompeting and competing research grants under the budget proposal?

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Dr. Gorden: The average increase in size for noncompeting research project grants in 1992 is $14,700. The average increase in size for competing research project grants in 1992 is $9,700.

Mr. Early: What was the downward negotiation rate for competing grants in Fiscal Year 1989 and Fiscal Year 1990?

Dr. Gorden: The downward negotiation rate for competing grants in fiscal Year 1989 was 10.5 percent. The downward negotiation rate in Fiscal Year 1990 was 14.7 percent.

Mr. Early:

What are you projecting for Fiscal Year 1991 ?

Dr. Gorden: For Fiscal Year 1991, we will be taking cost containment actions on our competing grants. Our strategy will be to rely primarily on the peer review percentile ranking system in determining which grants to fund and the level of support to be provided. Overall, we will need to save about 16 percent through these actions.

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Dr. Gorden: For Fiscal Year 1991, we will be able to allow a zero to two percent increase over the 1990 level of each grant, rather than the 4 percent usually allowed.

Mr. Early:

What is the BRDPI for these years?

Dr. Gorden: The BRDPI for Fiscal Years 1989, 1990, and 1991 are 5.20 percent, 5.80 percent, and 5.99 percent, respectively.

Mr. Early: Doctor, doesn't this institutionalize the large downward negotiations the institute has had to make in competing grants at peer-reviewed levels under the budget request?

Dr. Gorden: We are counting on the peer review system to more adequately address the cost issues in their review to minimize the administrative actions we must take to control growth in the average cost of the grant. The really large projects will have to be truly exceptional to be considered for funding, so I think there will be fewer really large applications and the whole thing will come into equilibrium.

Mr. Early: Doctor, will the NIDDK be able to fund noncompeting grants at commitment levels and new and competing grants at peerreviewed levels under the budget request?

Dr. Gorden: Noncompeting grants have for a number of years been limited to a four percent increase from one year to the next. In 1991, we have been able to provide only a zero to two percent increase over the 1990 level. In 1992, we hope to provide the full four percent increase. We expect that we will have to continue our

administrative cost containment activities related to new and competing grants in 1992 since it is unlikely that the peer-review process will yield recommended levels of support within the budgeted goals.

AWARD RATES

Mr. Early: What percentage of new and competing grants will the Institute fund under the Fiscal Year 1992 budget request, and how does this compare to Fiscal Year 1991 and Fiscal Year 1990?

Dr. Gorden: The Institute expects to fund 27 percent of approved new and competing applications in Fiscal Year 1992 as compared to 27 percent in Fiscal Year 1991 and 24 percent in Fiscal Year 1990.

Mr. Early: How does this compare to the award rate of five years ago? Ten years ago?

Dr. Gorden: The award rate of 27 percent in 1992 compares to the award rate of 40.3 percent in 1987 and 38.3 percent in 1982. The 1982 rate has been adjusted from 32.5 percent when applications approved for Arthritis have been excluded.

Mr. Early: What is the projected "success rate" and how does

Five years this compare to Fiscal Year 1991 and Fiscal Year 1990? ago? Ten years ago?

Dr. Gorden: The projected success rate for 1992 is 27 percent which compares to 27 percent in 1991 and 23 percent in 1990. lt also compares to the success rate of 38 percent for Fiscal Year 1987 and 34.2 percent for Fiscal Year 1982. The 1982 rate has been adjusted from 28 percent when applications received for Arthritis have been excluded.

QUALITY OF RESEARCH APPLICATIONS

Mr. Early: How would you characterize the quality of research applications the institute is receiving today? What kinds of comparisons would you make to prior years?

Dr. Gorden: The overall quality of the applications is excellent and seems to improve each year. Today, it is not enough to simply have an excellent application--it must be truly outstanding to be funded. In comparing these applications with those of ten years ago, I think that, with the advent of the sophisticated techniques of molecular biology, the focus of research has moved more to the molecular level. Por example, scientific disciplines such as genetics have been revolutionized by this technology, which has made it possible to identify and clone genes causing disease. In addition, using the polymerase chain reaction, researchers can amplify DNA for diagnosing genetic diseases, which 1s leading to new discoveries of mutations that cause genetic disorders.

And, of course, genetic engineering technology is the very basis for the emerging field of human gene therapy.

PERCENTILE PAYLINES

Mr. Early: To what payline percentile will the Institute be able to fund under the budget request and how does this compare to Fiscal Year 1991 and Fiscal Year 1990?

Dr. Gorden: NIH has projected that we will be able to reach the 24th percentile in 1991 and the 23rd percentile in 1992.

CLINICAL TRIALS

Mr. Early: Will you be able to continue the clinical trials now underway at the planned levels with the Fiscal Year 1992 budget request? Are there any that will have to be curtailed or stretched out?

Dr. Gorden: Our two major clinical trials, the "Diabetes Control and Complications Trial" and the "Modification of Diet in Renal Disease" trial, will be supported at levels to ensure their successful completion. The remainder of the smaller clinical trials, which are supported within our research grants mechanism, will be subject to the same administrative cost containment actions as all other research grants.

Mr. Early: Are there any clinical trials that could be undertaken in Fiscal Year 1992 if additional resources were available?

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Mr. Early: Please provide for the record a list of these, along with a brief description of the trial, its duration, the first year cost and the estimated total cost of the trial.

Dr. Gorden:

A table displaying this information follows.

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Nacional Institute of Diabetes and Digestive and Kidney Diseases

MAJOR NEW CLINICAL TRIALS READY TO BEGIN IN FISCAL YEAR 1992 IF FUNDS WERE AVAILABLE

(Dollars in thousands)

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$ 500

$ 1,550

Parathyroid Hormone (PTH) Therapy in Osteoporosis

To determine if subcutaneous administration
of low-dose PTH will increase bone density
in women already receiving estrogen.

2,000

15,300

10

Treatment(s) of Primary Biliary Cirrhosis

To test methotrexate and/or FK 506 as treatments in the early stages of primary biliary cirrhosis.

625

3,065

Preventive Therapy for Urolithiasis

To compare hydrochlorothiazide, inhibitor supplementation, and diet restriction in prevention of renal stones.

187

1,500

Surgical Intervention of Morbid Obesity

To study the indications for, complications
and benefits of, and specific procedures
associated with surgical intervention
in morbid obesity.

833

3,075

6

Comparison of Interventions for the Resolution of Symptomatic Benign Prostatic Hyperplasia (BPH)

To compare s-alpha reductase inhibitors and al pha blockers and to evaluate optimal time for intervention in BPH.

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