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February 1998 - Meeting Minutes

Department of Health and Human Services
Public Health Service
National Diabetes and Digestive and Kidney Diseases
Advisory Council
February 4-5, 1998

I. Call to Order

Dr. Gorden called to order the 146th National Diabetes and Digestive and Kidney Diseases Advisory Council meeting on February 4, 1998 at 8:40 a.m.

A. Attendance

Council Members Present (See Attachment A)

Dr. D. Montgomery Bissell, Jr.
Dr. Judith Bond
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 Podolsky
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. Richard J. Boxer
Dr. Jerrold M. Olefsky (ex officio)

B. Staff and Guests

In addition to Council members, others in attendance at the meeting included employees of the following organizations: NIDDK, NIH Office of the Director (OD), and Center for Scientific Review (CSR). 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 Ben Burton, NIDDK (Emeritus) Francisco Calvo, NIDDK Dolph Chianchiano, National Kidney Foundation Florence Cohen, NIDDK Catherine Cowie, NIDDK Leslie Curtis, NIDDK Charlenia Daniels, NIDDK Jane DeMouy, NIDDK Nancy Dixon, NIDDK Richard Eastman, NIDDK Linda Edgeman, NIDDK Bill Elzinga, NIDDK Jay Everhart, NIDDK Carol Feld, NIDDK Bill Foster, NIDDK Judith Fradkin, NIDDK Joanne Gallivan, NIDDK John Garthune, NIDDK Sanford Garfield, NIDDK Phillip Gorden, NIDDK C. Guan-Broder, NIDDK Roberta Haber, NIDDK Frank Hamilton, NIDDK Joan Harmon, NIDDK Mary Harris, NIDDK Maureen Harris, NIDDK Barbara Harrison, NIDDK Trudy Hillard, NIDDK Gladys Hirschman, NIDDK Carolyn Hodgkins, NIDDK Terri Holmes, NIDDK Jay Hoofnagle, NIDDK Karen Howard, NIDDK Van S. Hubbard, NIDDK Donna Huggins, NIDDK Nikita James, NIDDK Desiree Johnson, NIDDK Valerie Johnson, NIDDK Camille Jones, NIDDK M.A. Khan, CSR Sooja Kim, CSR Tom Kresina, NIDDK

Krish Krishnan, CSR John Kusek, NIDDK L. Earl Laurence, NIDDK Kim Law, NIDDK Helen Ling, NIDDK Mimi Lising, NIDDK Billie Mackey, NIDDK Denise Manouelian, NIDDK Donita Marconi, NIDDK Ronald Margolis, NIDDK Dan E. Matsumoto, NIDDK Ken May, NIDDK Ludlow McKay, NIDDK Catherine McKeon, NIDDK Pam Moore, Capitol Publications Lynn Morrison, American Gastroenterological Association Clifford Moss, NIDDK Beth Paterson, NIDDK Denise Payne, NIDDK Aretina Perry-Jones, NIDDK Judith Podskalny, NIDDK Carmen Robinson, NIDDK Jeanne Robinson, NIDDK Charles Rodgers, NIDDK M. James Scherbenske, NIDDK Paul Scott, OD, NIH Angela Sharpe, Consortium of Social Science Associates Michael Showe, NIDDK E. Singer, NIDDK Philip F. Smith, NIDDK Gloria Snowden, NIDDK Lawrence Soler, Juvenile Diabetes Foundation Walter Stolz, NIDDK Joan Talley, NIDDK Tommie S. Tralka, NIDDK George Tucker, NIDDK Charles A. Wells, NIDDK Nola Whitfield, NIDDK Susan Yanovski, NIDDK Rita Yeager, NIDDK 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 Wednesday, February 4, 1998 from 8:40 a.m. to 12:30 p.m., closed from 1:30 p.m. until 5:00 p.m., and again on Thursday, February 5, 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 12:00 p.m.

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:

May 27-28, 1998

September 14-15, 1998

February 17-18, 1999

June 16-17, 1999

September 8-9, 1999

February 2-3, 2000

May 31-June 1, 2000

September 20-21, 2000

IV. Director's Report

Dr. Gorden began his report by welcoming four new Council members, Ms. Genevieve Jackson, Drs. Kristen McNutt, Montgomery Bissell, and Daniel Podolsky. He announced that Dr. David Badman, Program Director of the Hematology Program, Division of Kidney, Urologic, and Hematologic Diseases, NIDDK, recently had received the American Society of Hematology's Award for Outstanding Service.

Dr. Gorden pointed out that the President's Budget request for FY 1999 specified that the NIDDK portion would be an 8.1 percent increase over its FY 1998 appropriation.

Dr. Gorden announced that the year 2000 would be the 50th anniversary of the NIDDK and invited Council members to become involved in planning commemorative events.

Mr. Laurence reviewed the NIDDK Budget for FY 1998 and the President's Budget request for FY 1999. He pointed out that the payline for regular research project grants would be left at the 25th percentile for new grants and the 27th percentile for renewal grants. He said that in FY 1998, a total of 2,494 regular research project grants were expected to be funded, while in FY 1999, under the President's Budget, it was anticipated that this number would increase to 2,610 grants. Mr. Laurence said that the NIDDK Intramural Budget, which had not been increasing at the same rate as the rest of the NIDDK, would receive an increase of 6 percent. He pointed out that additional funds offered the opportunity to use the planning process to implement a number of new and exciting programs.

Discussion

A Council member inquired about research training funding. He observed that although the research training dollars were going up, the numbers of trainees were going down. Mr. Laurence responded that a stipend increase was built into the FY 1999 training Budget. Council members inquired about how the trainee stipend was determined and whether trainees had to request the increased stipend. Mr. Laurence responded that the stipends were decided NIH-wide and not by individual institutes. A Council member said that the pre-doctoral and post-doctoral stipends did not pay a fair market price so, with added funds, this would be a good time to increase the stipends. Dr. Gorden said that the current NIH philosophy was to limit the numbers of trainees in favor of increasing the stipend level.

A Council member pointed out that clinical researchers took a substantial decrease in salary if they relied on NIH training grants when they went from clinical training to research training, compared with their clinical counterparts. He pointed out that data regarding how many clinicians were discouraged from taking the research route would be of interest. Dr. Gorden pointed out that attempts had been made to calibrate the NRSA salary scale to the national average of residents' salaries.

Council members were interested in how the training Budget and the Small Business Innovation Research Budget would be increased in relation to the rest of the NIDDK Budget. Mr. Laurence explained that the training Budget increased by 25 percent and that the SBIR Budget was stipulated by law to be 2.5 percent of the Institute's research Budget.

Council members expressed concern with motivating young investigators to go into the fields covered by the Institute because they could see assistant professors and more senior faculty struggling for grant support.

Council members were concerned about the decline in numbers of trainees and hoped that there would be enough talented, well-trained new investigators to meet future needs. Dr. Gorden said that reports from the Institute of Medicine relate to the issue of manpower needs. He pointed out that the Council's advice was needed on whether to focus on career development or on training.

V. Reports and Discussions

A. Update on Diabetes Program Activities

Dr. Gorden described some of the activities that involved the Institute's responsibility for coordinating diabetes research. He said that a Congressionally mandated working group had been established to do long-range planning for diabetes research and was chaired by Dr. C. Ronald Kahn of the Joslin Diabetes Center in Boston.

B. Possible Changes to NIDDK Career Development Awards

1. Changing the Terms of the K08

Dr. Stolz reported that there were two changes to the K08 that had been proposed:

A. To raise the salary to a maximum of $75,000 per year plus finge benefits; and

B. To increase the amount available for research expenses so as to promote the independence of K08 recipients during the last phase of their awards.

Dr. Stolz proposed to raise the salary of the K08 award to $75,000 per year and to stabilize the total number of career awards at 210 active awards. He outlined a proposal to offer a competitive 2-year small grant (R03) to all K08 recipients for the final 2 years of their K08. These applications would be reviewed by the training committee that reviewed competing K08 applications and would provide a mid-course check on recipients' progress as well as adding to the grantees' research resources at a time that it was needed.

2. A Career Award For Ph.D's?

Dr. Stolz discussed the proposed K01 which would target the Ph.D. who had completed training, but was not ready to competitively apply for the R01. He said that the K01 would be a mentored award and that the grantee could hold an R01 in its later years. He said that the Institute was planning to make up to 20 new K01 awards per year.

3. Career Award Support Specifically for Clinical Investigation

Dr. Stolz began by pointing out that the number of K08s supporting clinical research was very small, and he proposed a plan to increase these numbers by offering a variant of the K08 specifically tailored to the needs of clinical (patient-oriented) research. The 5-year award would have two phases: the first would contain substantial didactic training in such topics as biostatistics, research design, ethics, and epidemiology; and the second would be principally a program of guided research experiences in clinical research.

Discussion

K08/R03: Overall, the Council expressed enthusiasm for the concept of using an R03 to supplement the last 2 years of a K08.

A Council member liked some aspects of the suggested R03 awards; however, he pointed out that this award might not give the grantee the diversity of support that was needed in order to launch a truly independent research program once the K08 had ended.

Also, it was suggested that the fourth and fifth years of the K08 might be too late to effectively use the funds, and it was recommended that the R03 applications could be submitted at the end of the second year of the K08.

K01: Council members indicated that, in general, K01 awards should be given to applicants intending to work with mentors who would be new to them rather than mentors who had supervised their prior training. Also, Council members cautioned the staff against giving a K01 award to someone whose mentor would use it to extend his/her own research program rather than preparing the recipient for initiating a program of his/her own. Dr. Stolz said the staff had discussed the merits of a mentored award vs. a stand-alone award and identified two issues:

1. The NIH had just dropped the R29 FIRST award, and a stand-alone award could be seen as reinventing the R29 award.

2. Traditionally, small, unmentored grants have been unsuccessful as starter grants leading to R01s.

He said that these two factors had led the staff to recommend a mentored award.

Council members pointed out that $20,000 per year for research expenses would not allow the young investigator to become independent and suggested increasing that Budget item.

In response to questions about limiting the number of K01 awards to 20 per year, Dr. Gorden indicated that at this experimental stage, the Institute could support 20 awards without impacting on other grant numbers, and that the plan was to use this as an initial estimate for planning purposes until the amount of demand was known.

K08 for Clinical Research: Council members considered the proposals put forth as good ideas and some described how the K08 could be used to promote clinical investigation within their training programs. They also discussed the differences between the institutional training grants (K12) which were more expensive and would have fewer grants awarded and having the K08's spread out among more universities.

Dr. Gorden pointed out that the object was to develop a pilot project and to make the K08 grant more attractive by adding the potential for the R03 award. He said the 3-year award for the Ph.D. was important. He said to focus on the clinical aspects of the K08 award was important in order to increase the numbers of investigators doing clinical research.

Council members recommended adding tuition funds as well as research funds.

C. Update on Planning

Ms. Carol Feld reviewed the planning process for the Council and pointed out that Council members' recommendations were an important part of the developed plan. She described the planning process as beginning with an assessment or analysis of the existing portfolio chiefly by diseases and disciplines. Then the process moved on to identifying needs, opportunities, and problems, and to find strategies to address them. She pointed out that the planning process was ongoing and discussed two documents that were produced each year: "Research Progress Reviews" and "Program Initiative Concepts." She said that it was important to dovetail in a meaningful way the conceptual level of planning and the implementation level of planning.

D. The Role of the Council in Developing and Maintaining High Priority Areas of Research in NIDDK Extramural Programs

Dr. Gorden discussed ways the Council could help the Institute to maintain a high degree of scientific balance and relevance in its extramural programs. He described the mechanisms of "high program relevance" and "special consideration" that the Council members should use when considering applications outside the Institute's payline. He pointed out that with additional funds available, it was important for Council members to advise the Institute on growth and establishing priorities.

Discussion

A Council member pointed out that some of the past cost containment policies of the Institute should be re-examined and asked specifically about expanding the use of RFAs and program projects.

Dr. Gorden commented that one typical characteristic of grants funded from RFAs is that the grants sometimes do not fare well in CSR study sections when they are recompeted. He said that often the Institute had to publish a subsequent RFA in order to maintain research projects in the area.

Council members commented that the 4-year average time for a grant was not long enough for researchers to develop new data prior to having to write another grant proposal and that it was almost impossible for young investigators to compete successfully if they were required to recompete in less than 5 years. They were most concerned that with the demise of the R29, young investigators would be in a more precarious position. They recommended that the 4-year limitation be lifted.

Dr. Gorden explained that this was an NIH policy and might be difficult to change.

Council members also recommended awarding grants at the full recommended amount. Dr. Gorden explained that this step was being phased in gradually.

Council members expressed concern about the slowness of moving scientific advances from the bench to the bedside and asked if research in the area of health services delivery was within the NIH's mission. They recommended that in the area of diabetes, research on the delivery of care could be a role of the Diabetes Research and Training Centers (DRTCs). Dr. Gorden responded that research on health services delivery was the primary mission of the Agency for Health Care Policy and Research but that the NIH had some responsibility for this area. He said that each Diabetes Research and Training Center had an Model Demonstration Unit that demonstrated new ways of caring for diabetic patients.

Council members pointed out that with additional funds, The Instutute had the opportunity to improve the infrastructure of biomedical science. Dr. Gorden said some of that some aspects of scientific infrastructure was covered under indirect costs, center grants, and through other means.

Council members were in agreement that while it would help investigators for the Institute both to invest in infrastructure and to fund grant as recommended levels, they recognized that most of the funds would have to be applied to new programs, concepts, and ideas.

Council members pointed out that it was important for the NIH not to duplicate what could be done by industry.

VI. Scientific Presentation: Protein Tyrosine Phosphatases: Their Roles in Signal Transduction

Council member Dr. Jack Dixon gave the scientific presentation. He began by giving a short history of kinases and pointed out that kinases control a wide spectrum of activities within the cell. Dr. Dixon described his research on a tyrosine phosphatase in a genus of bacteria (Yersinia pestis and Yersinia tuberculosis) that had caused catastrophic world-wide diseases. He said that this tyrosine phosphatase was a thousand times more active than any mammalian phosphatases and was potentially a virulence gene in bacteria. He described how bacteria could use this phosphatase to disable the mammalian immune system. He elaborated on his research and steps taken to learn how these tyrosine phosphatases functioned. He pointed out the biological implications of understanding the functions, and said that with an understanding of the functions, it might be possible to design ways to inhibit this entire family of enzymes.

VII. Division Directors' Reports

A. Division of Extramural Activities

Dr. Stolz gave the Division report and announced the official discontinuation of the FIRST award (R29). He said that the receipt date of February 1 would be the last time that FIRST applications would be received, and that these applications would be reviewed at the September 1998 Council. He said that after this group of applications, there would be only R01 applications. He said that the discontinuation of the FIRST would allow the R01 mechanism to provide more adequate and flexible funding for new investigators. He indicated that the NIH planned to identify new investigators by running a search of all applicants coming in with new applications against the NIH database of past grants awarded. He reported that the study sections would review these as new investigators and that the NIH planned to track how these grants fared to make sure that an adequate number of new investigators received funding.

Discussion

Council members pointed out that the study sections previously focused on the individual rather than the projects or preliminary data when evaluating FIRST applications. They also expressed concern about variations among study sections in this regard. Dr. Stolz responded that the Center for Scientific Review had not yet issued guidelines or instructions to the study sections on how to review these new investigator applications. He said that the second level review had the responsibility to review the new investigator applications if the Council members did not like the way the study sections were reviewing them.

Council members expressed an interest in receiving a listing identifying the new investigator applications for their second level review.

B. Division of Diabetes, Endocrinology, and Metabolic Diseases

Dr. Eastman gave the Division report. He described the interest from the Congress in diabetes which resulted in a 15 to 20 percent increase in the Division's Budget for this year.

He reported that the Congress had mandated that a long-range plan for diabetes be developed over the next year. He said that this would involve coordinating diabetes research efforts across the NIH. He pointed out that this would mean conducting translational research that would have more of an immediate effect on public health.

C. Division of Digestive Diseases and Nutrition

Dr. Hoofnagle gave the Division report. He described the long-range planning process of the Division and the stategic plan on liver disease that had been developed at the request of the Congress. He reported on some of the activities called for in the strategic plan, such as the initiation of a clinical trial on hepatitis C using the contract mechanism of support. He said that the focus of this trial would be a study of the natural history of chronic hepatitis C and approaches to prevent progression to cirrhosis and cancer.

He reported another focus of the strategic plan involving hemochromocytosis. He said that a workshop was planned for May 14-15, 1998, on the gene and the implications for management of patient care. Another focus, he said, was liver disease in women and minorities and that a program announcement on this topic was planned. He described a workshop on motility and functional bowel disease that will be in June 1998. He described other areas of special interest to the Division, including Barrett's esophagus, celiac disease, and inflammatory bowel disease. In the areas of nutrition and obesity, he described a trans-NIH obesity initiative coordinated by Dr. Van Hubbard.

D. Division of Kidney, Urologic, and Hematological Diseases

Dr. Briggs gave the Division report and asked Dr. Leroy Nyberg to report on E. coli and the urinary tract. Dr. Nyberg described urinary tract infections as one of the most frequent infections encountered and said that 40 percent of adult women experience these infections at least once in their lifetime. He estimated health care costs at about $1 billion/per year, and he said that E. coli was a major cause of these infections. He described vaccine therapies that had been tried and that had encountered significant side effects. He reported that the latest vaccine that appeared promising blocked a single key protein on the bacteria and was currently being tested in primates.

Dr. Briggs described plans for a workshop to search for nephropathy susceptibility genes. She said the target was to identify genetic loci that confer susceptibility to diabetic nephropathy.

She described an NIH working group on urinary incontinence which included representatives from the National Institute on Aging, the National Institute of Child Health and Human Development, the National Institute of Nursing Research, and the Office of Research on Women's Health.

VIII. Consideration of Review of Grant Applications

Summary Table 1

* Includes both DK primary and secondary.
^ Minority Biomedical Support Program. This program is administered by the NIGMS but jointly funded by other ICDs.
Of these applications, 3 were received from institutions outside the U.S.A.

Council members made changes from the IRG recommendations in dollar amounts on 16 R29 applications and in years and/or dollar amounts on 17 applications.

Summary Table 2

Applications Taken to Council
Applications by Support Mechanism	Scored	NRFC	Deferred Applications	No Action	Total
Program Projects (P01)	5	-	-	-	5
Research (R01)	470	2	-	-	472
FIRST (R29)	37	-	-	-	37
MERIT (R37)	6	-	-	-	6
STTR (R41) (R42)	13 1	- -	- -	- -	13 1
SBIR (R43) (R44)	45 14	- -	- -	- -	45 14
Cooperative Agreements (U01)	16	-	-	-	16
Animal Model/Biol Resources Grants (P40)	1	-	-	-	1
Small Grants (R03)	6	-	-	-	6
Conferences (R13)	32	-	-	2	34
AREA (R15)	17	-	-	-	17
Exploratory/Devel. (R21)		-	-	-	14
R/R Research Proj. (R24)	1	-	-	-	1
Careers (K08)	22	-	-	-	22
Training (T32)	5	-	-	-	5
All Applications	705	2	-	2	709

Council members made changes from the Initial Review Group recommendations in dollar amounts on 16 R29 applications and in years and /or dollar amounts on 17 applications.

Summary Table 3

Applications Not Taken to Council
Categories by Support Mechanism	Bottom-Tier Applications	NRFC	Excluded by Inst. Staff	Non Compet.	Total Applications
Research (R01)	4	-	-	260	264
FIRST Awards (R29)	-	-	-	31	31
STTR Phase I (R41)	-	-	-	8	8
STTR Phase II (R42)	-	-	-	1	1
SBIR Phase I (R43)	-	1	-	47	48
SBIR Phase II (R44)	-	1	-	4	5
Small Grants (R03)	-	2	-	-	2
AREA Grants (R15)	-	-	-	9	9
Exploratory (R21)	-	-	-	1	1
R/R Research (R24)	-	1	-	-	1
All Applications	4	5	-	361	370

IX. Adjournment

Dr. Gorden thanked the Council members for their attendance and advice. There being no other business, Dr. Gorden adjourned the 146th meeting of the NDDK Advisory Council on February 5, 1998, 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.

Phillip Gorden, M.D.

Director, National Institute of Diabetes and Digestive and Kidney Diseases
and Chairman, National Diabetes and Digestive and Kidney Diseases Advisory Council