Department of Health and Human Services
Public Health Service
National Diabetes and Digestive and Kidney Diseases
Advisory Council
September 14-15, 1998
I. Call to Order
Dr. Gorden called to order the 148th NDDK Advisory Council meeting on September 14, 1998 at 8:40 a.m.
A. Attendance
Council Members Present (See Attachment A)
Dr. D. Montgomery Bissell, Jr.
Dr. Judith Bond
Dr. Richard J. Boxer
Dr. Jack E. Dixon
Dr. James R. Gavin, III
Dr. David M. Harlan (Ex Officio)
Ms. Ruby R. Haughton
Dr. Barbara E. Hayes
Ms. Genevieve Jackson
Dr. Saulo Klahr
Dr. S. Robert Levine
Dr. Kristen McNutt
Dr. Eric G. Neilson
Dr. Daniel Podalsky
Dr. Barbara J. Rolls
Dr. James Rothman
Dr. Joseph T. Spence (Ex Officio)
Dr. George Stamatoyannopoulos
Dr. Joseph H. Szurszewski
Dr. Richard D. Williams
Council Members Absent
Dr. Jerrold M. Olefsky
B. Staff and Guests
In addition to Council members, others in attendance at the meeting included NIDDK staff members, NIH Office of the Director (OD), Center for Scientific Review (CSR) formally the Division of Research Grants (DRG), Scientific Review Administrators, and other NIH staff members. Guests were present during the open parts of the meeting. Attendees included the following: Syed Amir, CSR; David Badman, NIDDK; Sharon Bourque, NIDDK; Josephine Briggs, NIDDK; Victor Buyny, NIDDK; Francisco Calvo, NIDDK; Syd Carter, NIDDK; Dolph Chianchiano, National Kidney Foundation; Paul Coates, NIDDK; Catherine Cowie, NIDDK; Leslie Curtis, NIDDK; Jane DeMouy, NIDDK; Nancy Dixon, NIDDK; Jacqueline Dobson, NIDDK; Richard Eastman, NIDDK; Linda Edgeman, NIDDK; Michael Edwards, NIDDK; Bill Elzinga, NIDDK; Gayla Elder-Leak, NIDDK; Jay Everhart, NIDDK; Ned Feder, NIDDK; Carol Feld, NIDDK; Bill Foster, NIDDK; Judith Fradkin, NIDDK; Joanne Gallivan, NIDDK; John Garthune, NIDDK; Phillip Gorden, NIDDK; Roberta Haber, NIDDK; Ann Hagan, NIDDK; Frank Hamilton, NIDDK; Joan Harmon, NIDDK; Mary Harris, NIDDK; Maureen Harris, NIDDK; Barbara Harrison, NIDDK; Trudy Hillard, NIDDK; Gladys Hirschman, NIDDK; Jay Hoofnagle, NIDDK; Van S. Hubbard, NIDDK; Donna Huggins, NIDDK; Camille Jones, NIDDK; Robin Kawazoe, NIH,OD; Sooja Kim, CSR; Tom Kresina, NIDDK; Krish Krishman, CSR; John Kusek, NIDDK; Maren Laughlin, NIDDK; L. Earl Laurence, NIDDK; Alec Liacouras, CSR; Mimi Lising, NIDDK; Liz Clancy Lyon, DDAL; Gerry Lynam, American Diabetes Association; Billie Mackey, NIDDK; Denise Manouelian, NIDDK; Ronald Margolis, NIDDK; Winnie Martinez, NIDDK; Dan E. Matsumoto, NIDDK; Ken May, NIDDK; Ludlow McKay, NIDDK; Catherine McKeon, NIDDK; Nancy Miller, NIH,OD; Pamela Moore, Capitol Communications; Lynn Morrison, American Gastroenterological Association; Neal Musto, NIDDK; Dianne Needham, NIDDK; Scott Osborne, CSR; Beth Paterson, NIDDK; Aretina Perry-Jones, NIDDK; Judith Podskalny, NIDDK; Rose Pruitt, NIDDK; Carmen Robinson, NIDDK; Alice Robinson, NIDDK; Charles Rodgers, NIDDK; Lakshmanan Sankaran, NIDDK; M. James Scherbenske, NIDDK; E. Singer, NIDDK; Paula Skedsvold, NIH, Office of Behavioral and Social Sciences; Philip F. Smith, NIDDK; Gloria Snowden, NIDDK; Lawrence Soler, Juvenile Diabetes Foundation; Walter Stolz, NIDDK; Tommie S. Tralka, NIDDK; George Tucker, NIDDK; Robert Umek, NIDDK; Charles A. Wells, NIDDK; Nola Whitfield, NIDDK; Jennifer Williamson, NIDDK; Susan Yanovski, NIDDK; Rita Yeager, NIDDK; E. Young, Juvenile Diabetes Foundation; and Charles Zellers, NIDDK.
C. Conflict of Interest Statement (See Attachment B)
Dr. Gorden called to the attention of the Council the Confidentiality and Conflict of Interest Statements. After discussing the scope of confidentiality and conflict of interest, he requested that Council members comply with the requirements. He reminded Council members to avoid a conflict of interest by leaving the room when the Council discussed individual applications in which an actual or perceived conflict of interest might occur. Members were asked to sign a statement to this effect. This did not apply to "en bloc" actions.
Dr. Gorden announced that the Council meeting would be open to the public in accordance with the provisions of Public Law 92-463 on Monday, September 14,1998, from 8:40 a.m. to 12:20 p.m., closed from 1:30 p.m. until 5:00 p.m., closed on Tuesday, September 15, 1998, from 8:30 a.m. to 10:00 a.m. for review, Discussion, and evaluation of grant applications, and open from 11:00 a.m. to 12 noon.
II. Consideration of the Summary Minutes of the Previous Meeting
The NDDK Advisory Council Summary Minutes of the last Council meeting were accepted unanimously by the Council members present.
III. Future Meeting Dates
Dr. Gorden asked for consideration of meeting dates for future NDDK Advisory Council meetings, and the following meeting dates were proposed and accepted:
February 17-18, 1999
June 1-2, 1999
September 8-9, 1999
February 2-3, 2000
May 31-June 1, 2000
September 20-21, 2000
IV. Director's Report (See Attachment C)
Dr. Gorden began his report by introducing new Institute staff members, Drs. Barbara Linder in the Division of Diabetes, Endocrinology, and Metabolic Diseases and Paul Kimmel in the Division of Kidney, Urologic, and Hematologic Diseases. Other appointments at the NIH that he announced included Drs. Gerald D. Fischbach, the new Director of the National Institute of Neurologic Diseases and Stroke, and Gerald T. Keusch, the new Associate Director for International Health and Fogarty International Center Director. He announced new appointments at the Department of Health and Human Services that included
Drs. Jeffrey P. Koplan, the new Director of Centers for Disease Control and Prevention, and Claude Earl Fox, Administrator of the Health Resources and Services Administration.
Budget
Mr. L. Earl Laurence discussed the Budget and indicated that the NIDDK expected to make a total of 608 competing research project grant awards in FY 1998. He said that new awards were funded to the 25th percentile and competing continuation awards were funded to the 27th percentile, with an overall success rate of approximately 31 percent. He pointed out that there was an increase in the average grant size in FY 1998.
He said that for FY 1999, the Institute would do well with an anticipated growth in the number of competing grants to 694 for a total portfolio of about 2600 research project grants. He reported an Intramural Division growth of 6 percent. He pointed out that there would be opportunities for new initiatives, for the average grant size to increase, and to fund more research project grants.
V. Reports and Discussion
A. Overview of FY 1999: Expected Budget, Paylines, and Implementation of Program Initiatives
Dr. Gorden said that, over the next 5 years, the Institute could be expected to receive significant Budget increases, if Congressional resolutions to double the NIH Budget over this time period are implemented. He indicated that Institute program plans had to be responsive to the language in the appropriations bills. He described some of the programs that had been launched, using as an example the National Diabetes Education Program and the release of obesity clinical guidelines.
Dr. Gorden pointed out that, because the Institute funded a number of grants beyond the payline in special areas of emphasis identified by the Council, the funding of some FY 1998 grants would be delayed until FY 1999 and the FY 1998 paylines would be carried over into FY 1999. Dr. Gorden asked Council members to consider several options if the Budget approved by Congress included more funds than the Institute currently anticipated. Those options were (1) to consider raising the payline, (2) to increase the average grant size, and (3) to put more funds into special interest areas; and he asked for any other options that they would recommend.
Discussion
Council members asked how the Institute compared with other institutes regarding investigator-initiated research compared with directed research through RFAs, special emphasis, or centers. Dr. Gorden responded that the special emphasis research grants were ones recommended by Council members and these grants came in as investigator-initiated research, but usually just missed the payline for funding. He pointed out that "special emphasis" or "special consideration" was the term used to differentiate these grants from "high program relevance," which meant that those grants were to be paid before any others.
A Council member recommended a special carve-out of funds from the Institute Budget or from new money to be used for Council-designated priorities or new initiatives. Dr. Gorden responded that Discussion was needed to identify from where in the Budget such funds could be obtained. He suggested defining "special emphasis" as grants selected by Council members that were beyond the payline, but that the Council members identified as being relevant to initiatives in the Institute's Annual Research Plan or related to other special research areas. He pointed out that the ways in which initiatives were selected and funded varied widely across the NIH. He explained the NIDDK historic policy of having an institute-wide payline in contrast to differing paylines for various divisions or diseases. He said that this policy could be changed if the Council members so desired.
Council members described how they wanted to continue grant-by-grant review for those grants selected for funding that were beyond the payline. They also were concerned that special emphasis grants should not be selected for payment because of pressure from special interest groups. They recommended that there be criteria to achieve a balanced portfolio. They also suggested that orphan areas might need special attention.
Dr. Briggs pointed out that special emphasis grants could support areas where subcouncils wanted to build more strength in the portfolio. She gave some examples of research that had been funded through special emphasis grants that had been innovative and significant.
Dr. Gorden pointed out that the Institute had to be responsive to the Congressional language in the appropriation bills. He said some of the priority setting had to be responsive to concerns among the advocacy groups. Council members pointed out that the increased funding for the NIH and the Institute emanated from the special interest groups.
Dr. Gorden said that if the science was not good, the NIH would not fund grants based just on pressure from the special interest groups. He also pointed out that the Institute had to be responsive to innovative research that cuts across institutes, giving the Zebrafish project and the mouse genome project as examples; and he said that the Institute would benefit from research emanating from those projects.
Council members were concerned about burden-of-illness issues and their impact on priority setting and allocation of resources. They pointed out that adequate data collection was difficult in determining the burden of illnesses, and they offered suggestions about how to take such issues into account in the Institute's planning process. To reduce the future burden of disease, they said it was important to focus on scientific opportunities that could have an impact on these diseases. They were concerned that scientific integrity be maintained in the planning process, and they were of the opinion that public needs could be served without compromising the science.
Council members recommended that RFAs and PAs be used to implement new initiatives because they would pull in more applications than would be seen by Council members in the general competition as special emphasis grants.
Some Council members indicated a preference for the use of the label "High Program Relevance" for grants that they wanted funded. Also, many Council members expressed concern with the use of burden-of-disease as a major criterion in funding decisions. They pointed out that, with this criterion, most of the funding would go to major diseases almost exclusively. They also pointed out that funding of research by pharmaceutical companies was not counted in the amounts spent on major diseases.
A. Priority Setting: A Discussion of the Report "Scientific Opportunities and Public Needs" (See Attachments D and E)
Ms. Robin Kawazoe from the NIH Director’s office gave an overview of the report titled "Scientific Opportunities and Public Needs: Improving Priority Setting and Public Input at the NIH" that was recently released to the Congress by the Institute of Medicine. There were 12 recommendations that she mentioned as she described the NIH plans for implementing these recommendations. She reported that the Director of the NIH was taking these recommendations seriously and moving forward to implement the recommendations beginning with public input into the priority-setting process.
Ms. Elizabeth Singer, NIDDK, reviewed for the Council the many sources of public input and advice utilized by the Institute. She described the many advisory panels, taskforces, working groups, and coordinating panels of NIDDK and some of the other groups that advised the NIDDK. She pointed out that the Divisions sponsored meetings where scientific input was solicited. She said that the name of her office would be changed to the Office of Communication and Public Liaison to reflect the added responsibility called for by the report.
Discussion
A Council member said that public advocates were interested in a cure or better treatment for their disease. Thus they were interested in a clinical end point as a goal and the public needed to be informed about how research related to their end goals. This would mean showing how funding areas of research moved toward solving specific clinical problems. Ms. Kawazoe responded that the message from the report focused on taking the cost and burden of disease into consideration in making funding decisions.
Dr. Gorden pointed out that there were two different points being made, and that the Council member was referring to how disease conditions were coded and how the NIH attached dollars to those codes and that initiatives and activities that related to that disease process should be included as well in describing the amount of funds being spent on specific diseases. He said that Ms. Kawazoe was describing the other side of the coin in which goals were being described in terms of burden on society of particular diseases. He said that these two ideas needed different approaches.
Council members were interested in how the report’s recommendations regarding public input would impact on the Council’s roles. Ms. Kawazoe responded that the Director, NIH, would use committees and councils to help determine the roles.
Council members were interested in how the strategic plans of the institutes would be used by the Director, NIH.
Ms. Kawazoe responded that some institutes that did not have strategic plans would be encouraged to develop them, and that it had been suggested that the strategic plans from all the institutes follow the same general approach.
Council members were interested in additional resources that might be required to implement the recommendations such as additional staffing. Ms. Kawazoe responded that it would depend on the institutes, as some institutes were already developing strategic plans and had public input while others did not and might require at least a public liaison person.
Council members pointed out that the strategic planning process would offer opportunities for the NIH to tell the public how the NIH was meeting its mission, how it approached solutions to specific clinical problems, and how it achieved clinical goals. They recommended NIH-wide strategic plans to address specific clinical problems. They also recommended that defining the disease burdens before prioritizing them would be of importance.
B. Progress Report: The Presidential and Congressional Initiative on Type I Diabetes Mellitus
Dr. Judith Fradkin gave a progress report on the 5-year Type 1 Diabetes Research Initiative funded under the Balanced Budget Act of 1997. She said that of the $30 million per year allocated to the program in FY 1998, $27 million went to the NIH and $3 million went to the Centers for Disease Control and Prevention. She said a group of experts was convened to develop priorities and to recommend scientific areas containing unusual opportunities for research. She discussed four RFAs that were issued for funding in FY 1998: (1) "Cellular and Molecular Approaches to Achieve Euglycemia;" (2) "Glucose Sensors in the Treatment of Type 1 Diabetes;" (3) "Pathogenesis and Therapy of Complications of Diabetes;" and (4) "Immunopathogenesis of Type 1 Diabetes Mellitus." She described how funds were to be allocated among the Institutes and Centers that co-sponsored the RFAs, and she pointed out that the grants funded from them were to be limited to 3 years, with pilot and feasibility grants limited to 2 years. She pointed out that a significant proportion of the applications received had come from new investigators or investigators who had not previously been working in the field of diabetes.
Discussion
Council members pointed out that this initiative was the result of a great deal of hard work on the part of the diabetes advocacy groups and that the process was successful in identifying research opportunities that might move the field forward.
Council members were concerned about what would happen after the 5 years of special funding ended. They questioned whether the Institute had to cover these grants. Dr. Fradkin said that not all of the grants would be in the Institute, as there were other NIH institutes involved, and this would swell the base of diabetes research in the other institutes as well. Dr. Gorden pointed out that decisions on whether to continue funding these projects would have to be made after 5 years.
A Council member pointed out that, whether research was done in clinical areas or was basic research, it all led to discoveries.
Another Council member said that much fundamental research was wrapped in goal-oriented research.
Council members discussed how to attract researchers working in other areas of research into areas of the Institute’s responsibility.
Council members said that the public should be informed about the research efforts being made by the Institute. Also, members voiced concerns about translating research findings from the laboratory to the general practitioner, particularly in the area of prevention. It was pointed out that the Department of Veterans' Affairs had developed methods of translation through a program called "Query" that focused on taking positive information from clinical trials and applying it to clinical care.
Dr. Gorden pointed out that the National Diabetes Education Program was focused on translation activities, but he said that suggestions for other approaches to translation were welcomed. He also pointed out that the current growth in the Budget coming on the heels of a no-growth period offered both challenges and opportunities in translating the results of research to clinical practice.
VI. Scientific Presentation: Dietary Fat and Obesity
Dr. Barbara Rolls gave the scientific presentation. She began her presentation by pointing out that the incidence of obesity was increasing and was not due entirely to obesity genes. She said there was a link between obesity and dietary fat and that obese individuals eat a higher proportion of their calories as fat. She described her research as studying satiety and satiation, and she operationally defined satiety as food consumption following a standard pre-load meal. She said a study of satiety would be to give a fixed amount of food and nutrients and then to see how it impacted on later food consumption.
Dr. Rolls pointed out that, in performing research involving satiety, it was important to keep the texture and taste of the foods consistent and matched. She described some of the behavior patterns she found as well as the results of studies where nutrients were infused intravenously and intragastrically. One of her major interests in studying obesity was the individual characteristics associated with the ability to compensate for calories. She reported that lean individuals adjusted their food intake during a meal for calories ingested during preloading while obese individuals did not. Also, she said her laboratory had focused its attention on energy density, which she defined as the amount of calories in a given weight of food. She said the lower the energy density in food the more you have to eat to keep your calorie intake at a constant level. In general, she said that fat in food raised the energy density and water and fiber in food lowered energy density. She found that the weight of food that people ate was more constant than either the fat content or the calorie content. Her conclusion was that some individuals could compensate for total energy content in the amount they ate, and she said that a future challenge would be to discover how this was done.
VII. Division Director's Reports
A. Division of Extramural Activities
Dr. Stolz led a Discussion about procedures through which Council members could designate certain applications outside the payline to be funded. Dr. Gorden had suggested that if the term "high program relevance" was confusing, it could be abandoned in favor of more explicit terms. It became evident that each division was using different designations for grants funded outside the payline. It was agreed to decide on the terminology at the next Council meeting.
A Council member had requested a portfolio analysis of grants from each of the divisions. The Division of Diabetes, Endocrinology, and Metabolic Diseases had done such an analysis, and Dr. Eastman explained that it had been very labor-intensive. A Council member pointed out that if the Council members were to help with priority setting, they would need the portfolio analysis as a minimum baseline of data. He pointed out the need to know what had been done in the past and to anticipate what needed to be done.
Dr. Gorden asked Council members for their advice on what they would recommend for use of additional funds should such increased funding become available. He pointed out that there were several ways these funds could be used, such as reducing the administrative cuts made by the Institute on the new grants. He said that it was planned to lower the reductions from 12 percent to 10 percent and asked Council members if they would recommend lowering them further. Another use of funds could be for initiatives that Council members considered of high priority. He said that the Institute had to be responsive to the language in the appropriations bill and, as an example, pointed out that additional PKD interdisciplinary centers would be funded.
Dr. Briggs pointed out that the Division of Kidney, Urologic and Hematologic Diseases recommended a higher payline for new investigators. Council members discussed the pros and cons of different paylines, with some members recommending funding 2 percentile points above the type 2 payline for new investigators. Council members pointed out that they were not happy with the disappearance of the R29 (FIRST Award), and others said that publicity about the higher payline would be attractive to new investigators. Some Council members expressed concern about the cost impact this would have on funding other grants and asked that a cost analysis be given to them in advance prior to the next Council meeting and before this decision would be made. Dr Gorden responded that this decision could wait until the next Council meeting when an analysis would be available and that it would not impact on funding the grants as the funding could be made retroactive.
B. Division of Diabetes, Endocrinology and Metabolic Diseases
(See attachment F)
Dr. Eastman began the Division's report with a review of the findings of the Diabetes Control and Complications Trial published in 1993. The trial showed that tight glucose control successfully reduced or delayed the development of diabetes microvascular complications in type 1 diabetes. He said that there has been only limited success in persuading practicing physicians to adopt tight control, particularly in the treatment of type 2 diabetics. He described the findings of a clinical trial in Great Britain that began in 1976 with about 5,000 type 2 patients (recruited between 1977 and 1991) with a mix of populations similar to the U.S. He said that the outcome of this trial also showed that tight control of glucose prevented or delayed the onset of diabetic complications. He said he hoped that publicity about this trial would help to convince primary care physicians that tight control of glucose was important for their type 2 patients.
Discussion
Council members asked if it was believed that this trial might motivate diabetes professional groups to change their recommended guidelines. Dr. Eastman said that he hoped the study helped to convince them to do so.
A Council member pointed out that the question of the use of angiotensin converting enzyme (ACE) inhibitors for blood pressure control had not been answered because they either had not been available or had not been widely used during most of the study. He said that it might take another decade before it could be known whether ACE inhibitors were appropriate or preferred. Dr. Eastman pointed out that it could not be said that there was no benefit with the use of ACE inhibitors as there was a renal protective effect. He agreed that it was still questionable.
C. Division of Digestive Diseases and Nutrition
Dr. Hoofnagle began his report by describing his division’s initiatives planned for next year. He said that the initiative on motility in the digestive tract was preceded by a workshop on motility of the enteric nervous system and smooth muscle function. He reported that an RFA would be announced shortly. He thanked outgoing Council member, Joseph Szurszewski, for his work on this initiative and the workshop. He said he was sorry also to lose Dr. Barbara Rolls as a Council member.
Dr. Hoofnagle asked Dr. Susan Yanovski to describe the new clinical trial that the Division was sponsoring on health outcomes of weight loss in type 2 diabetics. Dr. Yanovski described why the study was important and reported that overweight and obesity were affecting more than 50 percent of the American population. She said that among type 2 diabetics, more than 70 percent were overweight and a third were obese. She reported that obesity was associated with increased morbidity and mortality and that costs were approaching $100 billion per year. She pointed out that lay advocacy groups recommended making overweight people healthier and improving medical treatment for overweight people. She said that, even with the increase in obesity, cardiovascular health had improved in the U.S.
She said that the National Taskforce on Prevention and Treatment of Obesity recommended the trial on intentional weight loss to determine whether weight loss would improve health in obese individuals. She said that a workshop was convened to look at what was known about intentional weight loss in animal models and in human studies, and to identify questions that could be answered. The trial was designed to answer two questions: (1) do interventions designed to produce sustained weight loss in obese individuals with type 2 diabetes actually improve health and (2) how do the benefits or risks of interventions designed to produce weight loss compare to benefits or risks related to treatment of obesity and related co-morbid conditions in the absence of weight loss interventions.
Dr. Yanovski described the proposed design of the clinical trial as including three arms: (1) in the "control" arm, subjects would receive treatment for diabetes, hypertension, and lipidemia but would not be counseled on weight loss; (2) subjects would receive the same care with the addition of intensive behavioral counseling to help them lose weight; and (3) subjects would receive the same care with both behavioral counseling and pharmacotherapy to help them lose weight. She said that the trial was planned to include a 4 to 7 year follow-up, and it was anticipated that about 6,000 patients would be enrolled. Cardiovascular morbidity and mortality and risk factors for cardiovascular disease would be monitored as well. It was planned to assess progression of atherosclerosis by measuring the carotid intima wall thickness. At the conclusion of the study, she said it was hoped that answers would be provided to the questions to be studied such that a policy for treatment of obesity could be developed and there would be guidance on the risks and benefits of weight loss for the general population. She introduced Barbara Harrison, who would be monitoring the study on a day-to-day basis.
Discussion
A Council member asked about a target for glycemic control.
Dr. Yanovski responded that all physicians in the study would receive the target recommendations for glycemic control currently in use.
D. Division of Kidney, Urologic, and Hematologic Disease
Dr. Briggs introduced a new member of her staff, Dr. Paul Kimmel. She described three workshops that were held: a workshop on iron biology, which involved issues of chelation; a workshop on vascular access in dialysis patients; and a workshop on prostate disorders in minority populations. She said that both BPH and prostatic carcinoma were more common in African American populations.
Dr. Briggs reported that this was the 10th year of the United States Renal Data Service (USRDS), which publishes an annual report summarizing data on patients with end-stage renal disease treated with dialysis. She asked Dr. Lawrence Agodoa to report on the project.
Dr. Agodoa gave the history behind the USRDS and the undertaking by the Institute to develop the data base in 1988. He said the mission of the USRDS was to describe the patient population and treatment modalities, to report on incidence and prevalence, and to identify problems and opportunities for focused special studies. He reported the accomplishments and described the data and tables that had been published each year. He pointed out that the USRDS Annual Report was now available on the internet. He described other, comparable reports published and available from other countries. He said that the incidence in the U.S. of end-stage renal disease was increasing each year, primarily resulting from the increased incidence of diabetes in the U.S. population. He said that in 1978 17.3 percent of the end-stage renal disease patients were diabetic and in 1994 the percentage had risen to 40.1 percent. He pointed out that African and Native Americans had the highest rate of end-stage renal disease, and that the older population had significantly increased the end-stage renal disease numbers as well. He reported that there was no difference in mortality rates between the males and females, but that those over 65 had a higher mortality rate. Also, he said that African Americans had a slightly lower mortality rate. He said that vascular access was responsible for most of the hospitalizations. He gave some of the costs that have been increasing yearly. He pointed out that with transplantation, the first-year costs were very high, but after the first year, the costs dropped unless the transplant failed and then the costs were extensive again.
Discussion
A Council member pointed out that in 1978, nephrologists were not referring diabetic patients for transplantation and asked if the data reflected that point. Dr. Agodoa responded that the numbers he was giving were not only for transplantation but for all end-stage renal disease patients on dialysis.
VIII. Consideration of Review of Grant Applications
Summary Table 1
| Applications Taken to Council by Budget Category |
| Budget Category | Scored Applications | NRFC Applications | Deferred Applications | No Action | Total Applications |
| Regulary Research * (P01, R01, R29, R37, R43, R44) | 850 | - | 2 | - | 852 |
| Other Research * (R03, R13, R15, R21, K08) | 257 | - | - | - | 257 |
| Centers (P50) | 5 | - | - | - | 5 |
| Training * (T32) | 13 | - | - | - | 5 |
| Totals | 1,125 | - | 2 | - | 1,127 |
* Includes both DK primary and secondary
Of these applications, 17 were received from institutions outside the U.S.A.
Summary Table 2
| Applications Taken to Council by Support Mechanism |
| Support Mechanism | Scored Applications | NRFC Applications | Deferred Applications | No Action | Total Applications |
| Program Projects (P01) | 10 | - | - | - | 10 |
| Research (R01) | 750 | - | 2 | - | 732 |
| FIRST Awards (R29) | 20 | - | - | - | 20 |
| MERIT Awards (R37) | 4 | - | - | - | 4 |
| STTR (R41) (R42) | 13 1 | - | - | - | 13 1 |
| SBIR (R43) (R44) | 55 17 | - | - | - | 55 17 |
| Small Grants (R03) | 25 | - | - | - | 25 |
| Conferences (R13) | 26 | - | - | - | 26 |
| AREA (R15) | 11 | - | - | - | 11 |
| Exploratory/Developmental (R21) | 145 | - | - | - | 145 |
| Senior International Fellow (F01) | 1 | - | - | - | 1 |
| Careers (K02) (K08) (K12) | 2 40 6 | - - - | - - - | - - - | 2 40 6 |
| Core Centers (P30) | 5 | - | - | - | 5 |
| Training (T32) | 13 | - | - | - | 13 |
| Totals | 1,125 | - | 2 | - | 1,127 |
* Minority Biomedical Support Program
Council did not concur with IRG recommendations on 16 applications.
Summary Table 3
| Applications Not Taken to Council |
| Categories by Support Mechanism | Bottom-Tier Applications | NRFC Applications | Excluded by Institute Staff | Non-Comp | Total Applications |
| Traditional Research (R01) | 6 | - | - | 403 | 409 |
| FIRST Awards (R29) | - | - | - | 20 | 20 |
| STTR Phase I (R41) | - | - | - | 4 | 4 |
| SBIR Phase I (R43) | - | - | - | 57 | 57 |
| SBIR Phase II (R44) | - | - | - | 5 | 5 |
| Small Grants (R03) | - | 2 | - | - | 2 |
| AREA Grants (R15) | - | - | - | 5 | 5 |
| CIA (K08) | - | - | - | 1 | 1 |
| Special Centers (P50) | - | - | - | 22 | 22 |
| Exploratory/Developmental (R21) | - | 1 | - | - | 1 |
| Totals | 6 | 3 | - | 517 | 526 |
VIII. Adjournment
Dr. Gorden thanked the Council members for their attendance and advice. There being no other business, Dr. Gorden adjourned the 148th meeting of the NDDK Advisory Council on September 15, 1998, at 12:20 p.m.
I hereby certify that, to the best of my knowledge, the foregoing summary minutes and attachments are accurate and complete.
Phillip Gorden, M.D.
Director, National Institute of Diabetes and
Digestive and Kidney Diseases
and
Chairman, National Diabetes an Digestive and
Kidney Diseases Advisory Council
