Department of Health and Human Services
Public Health Service
National Diabetes and Digestive and Kidney Diseases
Advisory Council
September 20-21, 2000
I. Call to Order
Dr. Allen Spiegel called to order the 154th National Diabetes and Digestive and Kidney Diseases Advisory Council meeting on September 20, 2000, at 8:40 a.m.
A. Attendance Council Members Present (See Attachment A)
Dr. Edward J. Benz, Jr.
Dr. D. Montgomery Bissell, Jr.
Dr. Judith Bond
Dr. Burton Combes (Ad hoc)
Dr. Jeffrey I. Gordon
Hon. Levan Gordon
Ms. Ruby R. Haughton
Dr. Edward W. Holmes
Ms. Genevieve R. Jackson
Dr. C. Ronald Kahn
Dr. John McConnell
Dr. Kristen McNutt
Dr. Eric G. Neilson
Dr. Daniel Podolsky
Dr. Daniel Porte (Ex Officio)
Dr. Sandra Puczynski
Dr. Robert W. Schrier
Dr. Joseph T. Spence (Ex Officio)
Dr. Ming-Jer Tsai
Dr. Dana Weaver-Osterholz
Dr. Rena R. Wing
B. Staff and Guests
In addition to Council members, others in attendance at the meeting included NIDDK staff members, representatives of the NIH Office of the Director (OD), Center for Scientific Review (CSR) 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
Michelle Barnard, NIDDK
Pamela Belton, NIDDK
Johnny Bladen, NIDDK
Josephine Briggs, NIDDK
Ben Burton, NIDDK
Francisco Calvo, NIDDK
Syd Carter, NIDDK
Joan Chamberlain, NIDDK
Catherine Cowie, NIDDK
Leslie Curtis, NIDDK
Charlenia Daniels, NIDDK
Nancy Dixon, NIDDK
Jackie Dobson, NIDDK
Linda Edgeman, NIDDK
Bill Elzinga, NIDDK
Jay Everhart, NIDDK
Richard Farishian, NIDDK
Teresa Farris, NIDDK
Ned Feder, NIDDK
Carol Feld, NIDDK
Bill Foster, NIDDK
Judith Fradkin, NIDDK
Joanne Gallivan, NIDDK
Sandy Garfield, NIDDK
John Garthune, NIDDK
Ann Getz, NIDDK
Janet Gregory, NIDDK
Colleen Guay-Broder, NIDDK
Ann Hagan, NIDDK
Deb Hamernik, CSR
Frank Hamilton, NIDDK
Joan Harmon, NIDDK
Mary Harris, NIDDK
Maureen Harris, NIDDK
Barbara Harrison, NIDDK
Trude Hilliard, NIDDK
Gladys Hirschman, NIDDK
Jay Hoofnagle, NIDDK
Van S. Hubbard, NIDDK
Donna Huggins, NIDDK
Ann Jenkins, CSR
Desiree Johnson, NIDDK
Mary Beth Kester, NIDDK
M. A. Khan, CSR
Sooja K. Kim, CSR
Paul Kimmel, NIDDK
Diana Kly, OFMA
| Carolyn Kofa, NIDDK
Kathy Kranzfelder, NIDDK
Krish Krishman, CSR
John Kusek, NIDDK
Maren Laughlin, NIDDK
L. Earl Laurence, NIDDK
Kim M. Law, NIDDK
Todd Le, NIDDK
Maxine Lesniak, NIDDK
Alec S. Liacouras, CSR
Monica Liebert, NIDDK
Barbara Linder, NIDDK
Billie Mackey, NIDDK
Ronald Margolis, NIDDK
Winnie Martinez, NIDDK
Dan E. Matsumoto, NIDDK
Ken May, NIDDK
Kathy McKeon, NIDDK
Barbara Merchant, NIDDK
Carolyn Miles, NIDDK
David Miller, NIDDK
Barbara Minor, NIDDK
Neal Musto, NIDDK
Beth Paterson, NIDDK
Aretina Perry-Jones, NIDDK
Judith Podskalny, NIDDK
Sharon Pope, NIDDK
Rose Pruitt, NIDDK
Alice Robinson, NIDDK
Lakshmanan Sankaran, NIDDK
Sheryl Sato, NIDDK
Leonard Seeff, NIDDK
Jose Serrano, NIDDK
Nura Shehzad, The Blue Sheet
M. James Scherbenske, NIDDK
Elizabeth Singer, NIDDK
Philip F. Smith, NIDDK
Gloria Snowden, NIDDK
Jane Spencer, NIDDK
Robert Star, NIDDK
Joan Starr, NIDDK
Walter Stolz, NIDDK
Tommie Sue Tralka, NIDDK
George Tucker, NIDDK
Ana Velez, OFMA
Shan Wong, NIDDK
Susan Yanovski, NIDDK
Rita Yeager, NIDDK
Charles Zellers, NIDDK
|
C. Conflict of Interest Statement (See Attachment B)
Dr. Spiegel 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. Spiegel announced that the Council meeting would be open to the public in accordance with the provisions of Public Law 92-463 on Wednesday, September 20, 2000, from 8:30 a.m. to 12:30 p.m., closed from 1:30 p.m. until 5:30 p.m., closed on Thursday, September 21, 2000, from 8:00 a.m. until 11:00 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 Council members present accepted the NDDK Advisory Council Summary Minutes of the last Council meeting unanimously.
III. Future Meeting Dates
Dr. Spiegel asked for consideration of meeting dates for future NDDK Advisory Council meetings, and the following meeting dates were proposed and accepted:
February 7-8, 2001
May 30-31, 2001
September 20-21, 2001
February 13-14, 2002
May 30-31, 2002
September 18-19, 2002
IV. Director's Report
Dr. Spiegel introduced Dr. Burton Combes, who was attending in an ad hoc capacity. He announced the retirement of L. Earl Laurence, and said that Mr. Laurence would be honored at the NIDDK 50th Anniversary Party on Thursday evening, November 16, 2000, to be held at the NIH at The Cloisters. He also announced Dr. Walter Stolz's retirement at the end of the year, and said he would be honored at the Council dinner to be held that night at the Tragara Restaurant in Bethesda. Dr. Spiegel introduced Dr. Griffin Rodgers, Chief, Molecular and Clinical Hematology Branch, Division of Intramural Research, as the new Deputy Director of the NIDDK, who would be taking over the position on January 1, 2001, and he said a search was underway for Dr. Stolz's replacement. He announced job changes of some of the Council members, and the deaths of two grantees that were prominent gastroenterologists, John Walsh, M.D., University of California at Los Angeles, and Zdrvko Vlahcevic, M.D., of the Medical College of Virginia.
Within the Department of Health and Human Services, Dr. Greg Koski has assumed leadership of the Office of Human Research Protections, a new office that formerly had been the Office for Protection from Research Risks, prior to moving the office from NIH to the DHHS. He announced some new appointments at the NIH, and gave an update on the search activities for the new Director of the DEM Division and the new Intramural Director. He announced other retirements and departures from the Institute, including Drs. Camille Jones and Charles Rodgers, Ms. Nancy Dixon, and Mr. John Garthune. He announced that Ms. Carolyn Kofa and Ms. Teresa Farris had recently joined the Institute as grants management specialists. He said that Mr. Roberto Gomez was the new head of information technology in the Institute and Dr. David Miller would be joining the Office of Science Planning and Policy. He announced that Dr. James Hyde was joining the Division of Diabetes, Endocrinology and Metabolic Diseases, and that Drs. Thomas Hostetter and Paul Eggers would be joining the Division of Kidney, Urologic and Hematologic Diseases.
He said the Lasker Awards had been announced with the clinical award won by an NIH research scientist, Dr. Harvey Alter, who shared the award with Dr. Michael Houghton at Chiron Corporation. Dr. Alexander Varshansky at Cal Tech, and NIDDK MERIT grantee, won the basic science award. He shared the award with two Israeli scientists, Drs. Aaron Ciechanover and Avram Hershko.
Dr. Spiegel said there was renewed congressional interest in the "fair pricing" of drugs developed with the NIH support. He said that the Congress had pointed out that the taxpayer should not have to pay high prices for drugs developed in part with tax dollars.
Dr. Spiegel described several high profile issues at the NIH, one of which was the oversight of clinical research to ensure the protection of subjects, and another being real or apparent conflicts of interest on the part of scientists planning and executing research involving human subjects. He pointed out some of the issues of concern, such as differences in the FDA and NIH rules regarding conflicts of interest, the current IRB structure, and clinical research oversight mechanisms. He described not-for-cause site visits as part of the greater oversight of gene therapy trials.
He reported that the portion of the NIH budget spent for "Research Management and Services" (in other words administrative overhead) had been static in the past at an average of 4.5 percent, but had not kept pace with recent increases in the overall NIH budget and had dropped to about 3.3 percent. He said that this low overhead budget hampered the NIH staff in performing its appropriate oversight and stewardship functions and that there was a need for an increase.
Discussion
Council members discussed clinical oversight, and one member reported that the Department of Veterans Affairs (VA) had set up an accreditation process on contract that was external to the VA with site visits to research facilities on a tri-annual basis. It was pointed out that this would impact on universities because of the many affiliations with the VA throughout the country.
Council members were concerned about the cost of Institutional Review Boards (IRBs) at grantee institutions because they were seriously under-funded.
Council members commented about potential legislation to recoup some Federal expenditures for drug development, and they recommended that the NIH deal directly with the drug companies to recoup the drug costs and to omit the grantees from the loop. Council members pointed out that health care costs for the elderly were a congressional concern, but that it was the drug companies that set the pricing for drugs. It was pointed out that involvement in drug development was an important role for academic centers to play, particularly their involvement in clinical trials.
V. Budget Review
Dr. Spiegel described how some institutes set aside up to 25 percent of their budgets for special emphasis grants, and he said that during FY 2000 the NIDDK had set aside about $17 million for special emphasis grants. He said it was planned to set aside $20 million in FY 2001.
Mr. Laurence gave the budget report and began with a historical perspective before predicting the NIH budget would have approximately a 15 percent increase for the next fiscal year. He said for FY 2000, grants were paid to the 21st percentile for new grants and the 23rd percentile for competing continuation grants, with a total success rate of 32 percent. He predicted that the $30 million per year that the Department of Health and Human Services had received for the past 4 years for research on type 1 diabetes might be extended for another 5 years. He pointed out that through partnerships with lay and professional organizations and through CRADAs and gifts from industry, there was another $10 million expended for diabetes research for the current fiscal year. He said it was anticipated that the Institute would receive an increase of $175 million for the new fiscal year which would bring the payline to the 22nd and 24th percentiles with a success rate of 34 or 35 percent, with the potential of breaking the 3000 mark in numbers of new and continuing research project grants funded. He reported on growth in other parts of the NIDDK budget, such as the Division of Intramural Research.
Mr. Laurence also reported on the NIH Director's meeting. He said the meeting's prime speaker, Mr. Thomas Perez, Director of the U.S. Office of Civil Rights, discussed disparities in the U. S. population in health care. Mr. Laurence said Mr. Perez was speaking to the NIH institute directors to encourage the NIH to help with analysis of data and to help to determine whether the disparities were at the level of the physician or the institution and what could be done to remedy the problem. Mr. Laurence reported that Mr. Perez said he was committed to helping vulnerable populations obtain the health care services they needed.
Mr. Laurence said that this would be his last Council meeting, and that he had enjoyed working with Council members over the years.
Discussion
Council members expressed concern about launching new initiatives without the funds needed for success and asked where the funds for the new initiatives were allocated in the budget tables Mr. Laurence had presented. Dr. Spiegel pointed out several line items that would address the new directions in FY 2001, and that there were placeholders for some as well as financial flexibility. Also, he pointed out that some were scattered throughout the budget tables and were not as obvious.
Council members pointed out that the cost for the individual investigator had increased significantly, and if their planning promoted strategic alliances between individuals, it would increase the numbers of program projects and the current cap on program project grants would not allow adequate support in an increasing proportion of cases. They pointed out that other institutes without caps on program projects would draw applications from NIDDK grantees. They also pointed out that NIH funds did not fully support the research and the universities had to subsidize the research. It was pointed out that there was the potential that institutions would not be able to accept grants because of the lack of capital dollars for infrastructure and startup costs for researchers. They were concerned that the downward slide of clinical reimbursement was impacting on clinical research. Dr. Spiegel responded that the members had made many valid points but that the Institute had a finite budget. He said he would discuss these issues with representatives of the Institute's scientific and advocacy communities.
A Council member recommended that the Council should look at the budget process and develop scenarios of what happened to budget dollars. He suggested comparisons and scenarios of grant numbers versus grant size, versus programmatic areas, and to look into future years (1-5) to project consequences of decisions made with these scenarios. As an example he said, if the number of new grants would be increased in the first year, that would generate a certain number of new competitive renewals. He said that if those grants grew by a certain percentage per year, a projection of what that would do to the budget was needed. Dr. Spiegel responded that he was in agreement with the suggestion that a prospective analysis be done, and that this type of retrospective analysis had been presented at the February 2000 Council. Mr. Laurence pointed out that the overall NIH budget process played a part in how the funds were allocated trans-NIH. A Council member pointed out that as the number of new projects went up, the ability to act flexibly went down. Dr. Spiegel responded that the special emphasis mechanism and the issue of new investigators should be taken into consideration. He said that modeling would be an attempt to come to grips with examining the grants policy, and he said by looking at the policy in the context of these models, decisions could be made at future council meetings.
VI. Report of the Stem Cells and Developmental Biology Trans-Niddk Planning Group
Dr. Jeffrey Gordon gave the report from the stem cell planning group. He said the purpose of the planning group was to identify strategically important areas of science across disciplinary areas and to express the needs and focus of work in these science areas. He said it included not only the scope of science issues, but also the recognition that investigators needed to have adequate resources. He pointed out that the group not only had to define the plan, but to monitor implementation of the plan.
He said the group was composed of 14 people of which Drs. Benz, Bissell, Tsai, and himself served on the Advisory Council. He pointed out that this was an opportune time for stem cell research to go forward and that the NIDDK may make the most valuable contribution by providing infrastructure.
He described the plasticity of the stem cells and said that the hematopoietic stem cell, when transplanted into a variety of different hosts, could find a niche in other organs and express different fates. He said the idea was to use stem cells as a replacement in tissues where there were states of cell degeneration or there had to be correction of various types of biological processes.
He said the group initiated a planning process that included a description of research needs, a listing of the constituent communities to be considered in the planning process (including some fundamental developmental biologists), and the research areas covered by NIDDK (bone marrow stem cells, stem cells in the stomach and intestine, pancreas, liver, prostate, bladder, and kidney). He said working groups, composed of members of the planning group and outside experts, would be convened to develop this planning process. He said the planning group would generate a report that described the areas of need and an overview of what was known. He said after the Council members reviewed the report it would be posted on the Web and comments solicited. He said the goal was to develop a series of searchable databases so investigators could find and have distributed reagents expressed in stem cell populations. He said that a reagent distribution network and a system for finding where these reagents would be available was a critical component of infrastructure along with animal models that needed to be promoted. He said the group recommended training grant mechanisms as well as to encourage meetings in stem cell biology. He said bioinformatics was important for individuals to understand what constituted cellular states and cellular responses.
He summarized by pointing out that stem cells had been of interest for many years to those with interests in the hematopoietic system. He said the idea that stem cells had a greater degree of plasticity opened the door to a number of therapeutic interventions, such as the ability to genetically manipulate stem cell populations prior to their introduction to various tissues. He said this exciting opportunity transcended a number of disciplines including the research programs of the NIDDK.
He said the group's goal was a series of documents for the Council's deliberations and would result in a program of RFAs, and other initiatives to encourage the growth of this area.
Discussion
A Council member said that cross-talk between those involved in basic development and those that had a tissue-specific focus was important as a lot of science had to be done to establish the stem cells in mature tissue versus the cells that gave rise to the organ in the development stage.
Council members discussed the importance of training grants and stipends for supporting this area of research.
Council members made recommendations for announcing the Web-posted planning documents to gather as many comments from scientists and interested individuals as possible.
VII. Scientific Presentation: Functional Genomics of the Developing Endocrine Pancreas
Dr. Klaus Kaestner gave the scientific presentation. He said the aims of the functional genomics consortium were: first, to construct endocrine pancreas cDNA libraries from both the mouse and the human; second, to obtain adequate full length sequences for these cDNA libraries; third, to separate micro arrays from the mouse and the human for two comparisons and for developmental cores for expression profiling during pancreas development; and fourth, to establish a data base called Endocrine Pancreas Consortium Database, and, also, to provide bioinformatics support.
Dr. Kaestner said there was a human islet pancreas library and a mouse pancreatic islet library. He said he was responsible for two libraries, a new pancreatic islet library for the mouse and a second fetal library for the mouse. He described how nutrient 3 knockout mice developed the exocrine pancreas but none of the four endocrine linages, nor did they develop the endocrine stem cell linage as well.
He said the third aim was the assembly of a super pancreas chip that was a micro array enriched for pancreas or endocrine pancreas-specific mRNAs. He said the purpose of this was to provide the developmental profile of gene expression during endocrine pancreas development. He said that this would allow them to find groups of genes of importance only in endocrine stem cells, but not in the differentiated stem cells. He described how the RNA cells could be compared with reference RNA cells and through labeling their expression could be compared. After summarizing how this could be accomplished, he described the use of a database of transcribed sequences (DOTS) and RNA abundance database (RAD) and how these were used to further describe the data collected.
He described how the bioinformatic support had been helpful, particularly, the Endocrine Pancreas Consortium Data Base. He used examples to describe how the database had been searched, and the usefulness of the retrieval and how it could be used. He gave a time-line for completing the project, and said that in the Fall of 2000, they would finish testing their micro arrays, and in the Spring of 2001, he expected the completion of the sequencing of the first four cDNA libraries. He said that within the next 2 years, it was planned to have the annotation of all pancreas sequences.
VIII. Report of the Genetics, Genomics and Bioinformatics Trans-Niddk Planning Group
Dr. Edward Holmes gave the report. He said that the consequences of the genome project would change the way fundamental science was conducted and would impact on the way patients would be treated. He said the planning group focused on whether a trans-NIDDK or trans-NIH initiative to establish needed infrastructure would be enabling to NIDDK-sponsored investigators. He said the group looked at critical issues related to genetics using the genetics of type 2 diabetes as an example.
He described other initiatives, programs, and centers of importance that the NIDDK is involved with or sponsoring. He pointed out that benchmarks would be needed to assess the success of the initiatives that were trans-NIDDK or trans-NIH.
He then summarized the group's discussion of bioinformatics. He described the need for computational biology to analyze and interpret the enormous amount of data generated by modern genomic science. He pointed out that it was necessary to make available to investigators not only the technology available today but directions that the technology might take in the future as well. He said the planning group supported the mouse genome sequencing effort.
He said the planning group recommended four work groups that were to assess near-term applications and future needs. These included a work group on making bioinformatics expertise available, a work group on a genome anatomy project, a work group to develop an infrastructure for phenotyping, and a work group on the expansion and enhancement of the genetics consortium. He said the plan was to have draft documents on these four areas by the next meeting of the Advisory Council.
Discussion
Dr. Spiegel described the status of the mouse genome sequencing and the NIDDK's support for the project. He said much of the human genome sequence was unintelligible in terms of annotation or defining a gene without comparative sequence information primarily derived from the mouse. Council members were in agreement that the funds invested would be well spent for this important project.
IX. Report of the Disease Prevention and Management Trans-Niddk Planning Group
Dr. Robert Schrier gave the report for the Disease Prevention and Management Trans-NIDDK Planning Group. Since this group had not met prior to his report, he described the agenda for the meeting to be held immediately after the Council meeting. He said there were 128 clinical trials and cohort studies funded by the NIDDK, and the group would be asked to review these, to identify gaps that the NIDDK should address, and to make recommendations on studies that should be supported.
Dr. Schrier said that another issue to be addressed by the planning group was the development of repositories of biological samples.
Discussion
Council members recommended coordination with surgeons, as they would be a resource for tissues. They recommended that ethical issues should be discussed.
Council members pointed out that clinical investigators were trained as a result of ongoing clinical trials supported by the institute such as the long-term DCCT that had ended. They said that when new clinical trials were begun, some of the centers with strong clinical expertise from previous participation sent in applications for new clinical trials.
Council members recommended coordination with foundations for recruiting and retention of patients in clinical trials and drug companies to help fund some of the clinical trials. They discussed other ways to involve drug companies and other industries in upcoming clinical trials. They also recommended targeting at risk populations for patient education for testing for some of the diseases and development of leadership in the at risk populations. Other methods of recruiting patients as well as methods of interesting young physicians in clinical research were discussed.
X. Reports of Division Directors
A. Division of Extramural Activities
Dr. Stolz gave the Division report. He reported that over 5,000 awards would be made by the end of FY 2000, and he pointed out that due to the many RFAs that had been issued in FY 2000, the workload of the Review Branch had been heavy. He said that he had been honored to be associated with the Council for the past 17 years and that this would be his last Council meeting before retiring from Federal service.
B. Division of Diabetes, Endocrinology and Metabolic Diseases
Acting Division Director, Dr. Judith Fradkin gave the Division report. She began with an overview of recent program initiatives that had been undertaken. In describing the RFA on neurologic complications of diabetes, she said that neuropathy had been identified by the Diabetes Research Working Group as one of the least-studied and least-understood complications of diabetes. Only $3 million or less than 1 percent of the research budget in diabetes was devoted to this problem. She described five areas that needed attention: peripheral neuropathy, autonomic neuropathy, foot disease, stroke, and hypoglycemia. She described the RFAs that had been issued to address these problems and the partnership with other institutes and outside organizations to coordinate efforts on approaching these problems with the object of eventually having clinical trials on prevention of neuropathy. She described the RFA on diabetic foot disease, and she outlined an outreach program by the Institute to reach diabetic health care providers with patient information about diabetic foot care. She said that hypoglycemia was a limiting factor in management of type 1 and type 2 diabetes in terms of good glycemic control, and she reported on the outcome of a meeting that included several institutes and lay organizations that resulted in the focus for further research. She said a number of clinical questions had been identified. She thanked staff members for their contributions to the success of the meeting and the mission of addressing neurological complications of diabetes.
C. Division of Digestive Diseases and Nutrition
Dr. Hoofnagle gave the Division report. He described meetings planned on the mechanisms of drug-induced liver disease and what can be done to control the problem. He said that this will be an increasing problem and a hard problem to study. Another meeting he described was on living donor liver transplantation. He said that about 1000 people die each year waiting for a liver to become available for transplanting. He said the numbers of living donor liver transplants had tripled between 1998 and 1999 and that this meeting was organized to address the issues raised as well as research needs.
He described a clinical trial of long-term therapy of interferon for hepatitis C and he asked Dr. Leonard Seeff to report on it.
Dr. Seeff said that about 4 million people in the U.S. had been exposed to hepatitis C and about 3 million people were infected with hepatitis C. He said that there would be a threefold increase in hepatitis C-related end-stage-liver disease in the next decade. He said that current treatment for chronic hepatitis C was with interferon and ribavirin. He reported that the clinical trial was designed to study and evaluate the safety and efficacy of long-term use of a new form of interferon in patients that had not responded to the older form of interferon combined with ribavirin. He said that a number of ancillary studies were planned in an effort to understand the pathogenesis and progression of liver disease, of fibrosis, and of hepatocellular carcinoma. He said that, since there was a higher incidence of liver cancer in Japan, they were trying to do a similar study in Japan to compare the outcome and risk factors for progression to hepatocellular carcinoma between the two countries.
Discussion
A Council member asked about the increased risk for hepatitis C among first-alert people such as fire fighters, EMTs etc. Dr. Hoofnagle responded that in comparison with the age groups, the outbreak of hepatitis C among first-alert people was the same for the age group in the general population. He said that it is a silent disease and people learn they have the disease only if they are tested. He said a number of first-alert people were tested and were shocked to learn that they had hepatitis C.
A Council member asked what recommendations should be made when people such as first-alert people test positive for hepatitis C. Dr. Seeff replied that there were 64 pages of guidelines from the American Association for the Study of Liver Disease, and he would make them available.
D. Division of Kidney, Urologic, and Hematologic Diseases
Dr. Briggs gave the Division report. She began her report by describing a highly successful workshop, organized by the Division, on career training that included clinical trial design, a journal club, and a mock study section. She thanked Council members who had been involved in the workshop.
She gave an update on progress by the Division in organizing the National Kidney Disease Education Program, and she introduced Dr. Thomas Hostetter who will be helping to launch the program.
Dr. Briggs described a trans-NIDDK initiative that the Division was sponsoring to develop mouse models of diabetes in anticipation that the mice would also develop accelerated diabetic kidney disease along with other diabetes complications.
She described an advance that involved genes that affect podocytes. She described the finding of three genes that affected protein loss in the kidney. She said the podocytes had a foot-like part that lined the urinary space and normally prevented proteins from leaking from the blood into the urine. She said that these cells had potential for being the target cells to understand proteinuric states resulting in progressive kidney disease.
Discussion
A Council member recommended an integrated plan for an education program in kidney disease and he gave an example.
XI. Consideration of Review of Grant Applications
Summary Table 1
Applications Taken to Council by Budget Category | All Applications by Budget Category | Scored Applications | NRFC Applications | Deferred Applications | No Action | Totals |
| Regular Research* (P01, P40, R01, R37, R41, R42, R43, R44, U01) | 829 | - | 1 | - | 830 |
| Other Research* (R03, R13, R15, R18, R21, R24, R25, K01, K02, K08, K23, K24, K25, U13) | 279 | - | - | - | 279 |
| Centers (P50) | 6 | - | - | - | 6 |
| Training* (T32) | 5 | - | - | - | 5 |
MBS (S06)
^ DK Secondary only | - | - | - | - | - |
| Totals | 1,119 | - | 1 | - | 1,120 |
* Includes both DK primary and secondary
^ Minority Biomedical Support Program. (This program is administered by the NIGMS but jointly funded by other ICD's. The Council concurred with NIDDK recommendations for scoring these grant applications).
Of these applications, 3 were received from institutions outside the U.S.A.
Summary Table 2
Applications Taken to Council | Applications by Support Mechanism | Scored Applications | NRFC Applications | Deferred Applications | No Action | Totals |
| Program Projects (P01) | 5 | - | - | - | 5 |
| Research (R01) | 721 | - | 1 | - | 722 |
| MERIT (R37) | 1 | - | - | - | 1 |
| AMABMR Grants (P40) | 1 | - | - | - | 1 |
| STTR (R41) | 5 | - | - | - | 5 |
| STTR (R42) | 4 | - | - | - | 4 |
| SBIR (R43) | 54 | - | - | - | 54 |
| SBIR (R44) | 23 | - | - | - | 23 |
| Small Grants (R03) | 38 | - | - | - | 38 |
| Conferences (R13) | 27 | - | - | - | 27 |
| AREA (R15) | 8 | - | - | - | 8 |
| RDDP (R18) | 1 | - | - | - | 1 |
| Exploratory/Develop. (R21) | 80 | - | - | - | 80 |
| RR Research Grants (R24) | 30 | - | - | - | 30 |
| Education Projects (R25) | 1 | - | - | - | 1 |
| Cooperative-Agree (U01) | 15 | - | - | - | 15 |
| Cooperative-Agree Conf (U13) | 1 | - | - | - | 1 |
| Careers (K01) | 23 | - | - | - | 23 |
| Careers (K02) | 1 | - | - | - | 1 |
| CIA (K08) | 39 | - | - | - | 39 |
| PSA (K23) | 18 | - | - | - | 18 |
| PSA (K24) | 9 | - | - | - | 9 |
| MQRCDA (K25) | 3 | - | - | - | 3 |
| Specialized Center (P50) | 6 | - | - | - | 6 |
| Training (T32) | 5 | - | - | - | 5 |
MBS (S06)
DK Secondary only | - | - | - | - | - |
| Totals | 1,119 | - | 1 | - | 1,120 |
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) | 4 | - | - | 470 | 474 |
| STTR Phase I (R41) | - | - | - | 3 | 3 |
| STTR Phase II (R42) | - | - | - | 1 | 1 |
| SBIR Phase I (R43) | - | 5 | - | 50 | 55 |
| SBIR Phase II (R44) | - | 1 | - | 5 | 6 |
| Small Grants (R03) | - | 4 | - | 1 | 5 |
| AREA Grants (R15) | - | - | - | 3 | 3 |
| Exploratory/Devel (R21) | - | - | - | 48 | 48 |
| RR Research Proj (R24) | - | - | - | 5 | 5 |
| Coop-Agreements (U01) | - | - | - | 7 | 7 |
| CIA (K08) | - | - | - | 1 | 1 |
| MP-ORCDA (K23) | - | - | - | 1 | 1 |
| Special Centers (P50) | - | - | - | 5 | 5 |
| Short-Term Res Training (T35) | - | 1 | - | - | 1 |
| Totals | 4 | 11 | - | 600 | 615 |
XI. Adjournment
Dr. Spiegel thanked the Council members for their attendance and advice. There being no other business, Dr. Spiegel adjourned the 154th meeting of the NDDK Advisory Council on September 21, 2000, at 11:50 a.m.
I hereby certify that, to the best of my knowledge, the foregoing summary minutes and attachments are accurate and complete.
Allen Spiegel, M.D.
Director, National Institute of Diabetes and Digestive and Kidney Diseases
and Chairman, National Diabetes and Digestive and Kidney Diseases Advisory Council
