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June 1999 - Meeting Minutes

A. Attendance

Council Members Present (See Attachment A)
Dr. John W. Adamson (Ad hoc)
Dr. D. Montgomery Bissell, Jr.
Dr. Judith Bond
Dr. Pamela B. Davis (Ad hoc)
Dr. Jeffrey I. Gordon
Ms. Ruby R. Haughton
Dr. Barbara E. Hayes
Ms. Genevieve R. Jackson
Dr. C. Ronald Kahn
Dr. S. Robert Levine
Dr. John McConnell
Dr. Eric G. Neilson
Dr. Daniel Podalsky
Dr. Robert W. Schrier
Dr. Joseph T. Spence (Ex Officio)
Dr. Joseph H. Szurszewski (Ad hoc)
Dr. Ming-Jer Tsai
Dr. Dana Weaver-Osterholz
Dr. Rena R. Wing

Council Members Absent

Dr. Kristen McNutt

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:

David Badman, NIDDK Pamela Belton, NIDDK Philippa Benson, NIDDK Sharon Bourque, NIDDK Josephine Briggs, NIDDK Ben Burton, NIDDK Victor Buyny, NIDDK Francisco Calvo, NIDDK Joan Chamberlain, NIDDK Dolph Chianchiano, National Kidney Foundation Cheryl Chick, NIDDK Naomi Churchill-Earp, NIDDK Catherine Cowie, NIDDK Leslie Curtis, NIDDK Charlenia Daniels, NIDDK Florence Danshes, NIDDK Jane DeMouy, NIDDK Nancy Dixon, NIDDK Morgan Downey, American Obesity Association Richard Eastman, NIDDK Linda Edgeman, NIDDK Bill Elzinga, NIDDK Jay Everhart, NIDDK Richard Farishian, NIDDK Ned Feder, NIDDK Carol Feld, NIDDK Bill Foster, NIDDK Judith Fradkin, NIDDK Joanne Gallivan, NIDDK Chhanda Gangula, NIDDK Sandy Garfield, NIDDK: John Garthune, NIDDK Phillip Gorden, 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 Terri Holmes, NIDDK Jay Hoofnagle, NIDDK Van S. Hubbard, NIDDK Donna Huggins, NIDDK Amy B. Huber, American Foundation for Urologic Diseases Desiree Johnson, NIDDK Ephraim Johnson, NIDDK Camille Jones, NIDDK Kieran Kelley, NIDDK

Sooja Kim, CSR Paul Kimmel, NIDDK Tom Kresina, NIDDK Krish Krishman, CSR John Kusek, NIDDK Maren Laughlin, NIDDK L. Earl Laurence, NIDDK Kim Law, NIDDK Alec Liacouras, CSR Barbara Linder, NIDDK Helen Ling, NIDDK Mimi Lising, NIDDK Billie Mackey, NIDDK Denise Manouelian, NIDDK Donita Marconi, NIDDK Ronald Margolies, NIDDK Winnie Martinez, NIDDK Dan E. Matsumoto, NIDDK Ken May, NIDDK Catherine McKeon, NIDDK Marjorie Mitchell, NIDDK Pamela Moore, Capital Publication/Aspen Publications Robert Morrison, American Society of Nephrology Neal Musto, NIDDK Denise Payne, NIDDK Aretina Perry-Jones, NIDDK Judith Podskalny, NIDDK Sharon Pope, NIDDK Rose Pruitt, NIDDK Carmen Robinson, NIDDK Alice Robinson, NIDDK Charles Rodgers, NIDDK Mary Kay Rosenberg, NIDDK Lakshmanan Sankaran, NIDDK Sheryl Sato, NIDDK M. James Scherbenske, NIDDK Jose Serrano, NIDDK Elizabeth Singer, NIDDK Philip F. Smith, NIDDK Gloria Snowden, NIDDK Robert Star, NIDDK Walter Stolz, NIDDK Tommie S. Tralka, NIDDK George Tucker, NIDDK Charles A. Wells, NIDDK Nola Whitfield, NIDDK Shan S. Wong, 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 Tuesday, June 1, 1999 from 1:00 p.m. to 2:30 p.m., closed from 2:30 p.m. until 5:00 p.m., closed on Wednesday, June 2, 1999 from 8:00 a.m. to 10:30 a.m. for review, discussion, and evaluation of grant applications, and open from 10:30 a.m. to 1:00 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:

September 9-10, 1999

February 2-3, 2000

May 31-June 1, 2000

September 20-21, 2000

February 7-8, 2001

May 30-31, 2001

September 20-21, 2001

IV. Director's Report (See Attachment C)

Dr. Gorden began his report by introducing a new Council member, Dr. Robert Schrier, and three ad hoc Council members, Drs. John Adamson, Joseph Szurszewski,and Pamela Davis. He announced that two ex officio Council members were leaving, Drs. David Harlan and Jerrold Olefsky. He announced that Dr. David Harlan would be joining the NIDDK Intramural program to head a newly created unit focusing on immunology. Dr. Gorden announced several new appointments and awards received by the NIDDK staff.

Budget

Dr. Gorden said said that one of the most important issues was to maintain the payline for the Institute at the 25th percentile and the 27th percentile for competing continuation applications. He reported that it appeared the Institute would be able to continue these paylines and to meet all the legislative directives as well as absorbing the growth in the new career awards, K23, K24, and K30. He said that two new center grants would be awarded, one in diabetes and one in digestive diseases. He reported that two congressional earmarks would be met, one in diabetes and one in prostate research.

Discussion

A Council member said that he understood the Council to say that it wanted the payline preserved in FY 1999, but for FY 2000 if more funds were not forth coming, then the special initiatives should be implemented even if the payline had to drop below the 25th percentile and the 27th percentile.

A Council member asked about the payline for the K awards. Dr. Gorden responded that the K payline was left up to the Subcouncils' discretion within limits set by the Institute.

V. NIDDK Strategic Planning

Ms. Carol Feld presented the conceptual framework for the new NIDDK Strategic Plan for the Council's general Discussion and approval. She said that the new plan will differ from previous planning processes in several ways. It will address a 5-year time span; be organized in terms of cross-cutting scientific opportunities and needs; and include scientific implementation strategies, that do not contain Budget proposals. The new plan will use disease examples to illustrate the cross-cutting, global scientific themes, but the document will not be organized along division or program lines. It is not an advocacy document. An effort will be made to promote trans-NIH scientific areas, with a view toward enhancing collaborations. Public input to the plan is being solicited. The document will be written in language understandable to the lay public and distribution will be through the Internet as well as other means. The Institute to have a wide distribution of the plan. She said the Institute will build upon plans available now that have included public input. Ms. Feld named as examples, the new Diabetes Research Working Group plan, the plans that Dr. Briggs had developed with the nephrology community, and the Healthy People for Year 2010.

Ms. Feld described five working groups that would be assisting the NIDDK to develop its new Strategic Plan. Each is chaired by a senior NIDDK staff member. She said that the plan will contain background information, goals, and objectives, along with implementation strategies to realize the stated objectives. On the NIDDK Internet home page, there is a link to a letter from Dr. Gorden asking for comments and inviting input on the Strategic Plan. The time line will allow the Council members to review some of the draft plan at the September Council meeting. The draft plan is due to Dr. Varmus by December 31, 1999, as part of the NIH response to an Institute of Medicine study on improving priority setting and public input at the NIH.

Discussion

Council members recommended that the period for comments be closed in mid-November, and they were willing to spend extra time at the September Council meeting to review and work on the strategic plan.

Council members asked about issues that would cut across the various NIH institutes' boundaries and how these would be handled. Dr. Gorden responded that the categories would be discussed at a meeting with Dr. Varmus.

Council members recommended that the public comment could be included as an appendix so the public's comments could be read by all. Some Council members also expressed concern that the NIDDK may not get what it expects from public comments. Others responded that public input was very important and patients' stories would be important for Council members to hear in addition to the scientific community comments. Dr. Gorden responded that it may be up to the Council members to help put together the major parts of the plan, and that the plan could be modified based on Council members recommendations.

VI. Reports and Discussions

A. NIDDK Initiatives for FY 2000

Dr. Gorden described several initiatives that were planned for the FY 2000 Budget that would total about $8.8 million. These included an RFA in GI tract motility relating to irritable bowel syndrome, PKD diagnosis and imaging, urinary incontinence, prevalence and diagnosis of celiac disease, an initiative in iron overload therapeutics, and an RFP related to an urologic diseases database. He reported on several collaborative projects with other NIH institutes that represented relatively small contributions of the Institute. These included a bioengineering research initiative that was NIH-wide and projects in hepatitis C, inflammatory bowel disease, Barrett's esophagitis, and a mouse mutagenesis project. The Institute plans to announce an RFA along with a series of workshops, collaborating with NINDS on diabetic neuropathy. Also, the Institute plans an RFA on prevention and therapy of type 1 diabetes. Dr. Gorden described a new project that must be considered in the context of the overall Budget, a biotechnology center project.

He said that to implement all of these planned initiatives under the President's FY 2000 could cause the general grant payline to drop to the 20th and 22nd percentiles.

Discussion

Council members expressed concern about the uncertainty of any funds forthcoming from the Congress above the President's Budget. They were concerned about programs such as the biotechnology program being initiated without additional funds to pay for it. Other Council members argued that it was important to plan for new initiatives, even if the funds would not be available for FY 2000.

Council members inquired about the percentage of grants that were R01's and asked about the Budget for FY 2000. Dr. Gorden responded that the Budget would be about $1 billion, and the R01 grants represented about 80 percent of the portfolio.

Council members were interested in how the NIDDK's paylines of 25th percentile and 27th percentile compared with other institutes. Dr. Gorden responded that the definition of "payline" varied somewhat from institute to institute so that comparisons were difficult. Council members pointed out that the NIDDK had more RFAs than many institutes.

Council members inquired about how much more funding would be needed from the Congress above the President's Budget to keep the payline the same as in previous years and implement the initiatives that the Institute was planning. Dr. Gorden responded that $60 million in additional funds would be needed. He also pointed out that if the Congress appropriated more funds over the President's Budget, these funds often came with directives for how they should be used. He pointed out that the Institute tried to keep the paylines the same across the Divisions, but that it would be up to the Council to make recommendations if they wanted this policy changed for programs of high interest.

B. A Program to Support the Development and Use of Advanced Technologies in Biomedical Research

Council member Jeffrey Gordon reported on the deliberations of an ad hoc group convened to develop an initiative that would make the tools of functional genomics available to a wider spectrum of NIDDK grantees. He pointed out that the high cost of these new technologies put them out of the reach of many scientists in the universities. The group proposed that the NIDDK take a proactive role to stimulate methods of gaining access to these technologies without endorsing any particular technology. It was considered important that access to the technology should serve individual investigators or groups of investigators and that applying these technologies should be made through peer reviewed applications.

The committee proposed two components:

1. supplemental grants for current holders of NIDDK research grants, with $35,000 in direct costs for each supplement; and
2. cores would be developed for supporting this technology and NIDDK investigators would have access to these technologies through the cores either within the institution or between institutions. These grants would be a maximum of $350,000 per year in direct costs with a limit of one core per institution.

Discussion

A Council member asked if a survey had been done to determine whether cores such as those proposed were underway. Dr. Briggs pointed out that the NCI had an RFA out for equipment support as a supplemental grant to cancer centers grants.

Council members were concerned that without additional funds over the President's Budget that it would be necessary to drop the payline to pay for this new initiative. Other Council members expressed the idea that this would send the positive message that the NIDDK was interested in making the new technology available to its grantees. Some Council members proposed waiting to implement this initiative to see if the Congress increased the NIDDK Budget over the President's Budget.

Dr. Gorden went around the table asking for an informal vote for this new initiative and of the Council members present, 12 voted for the new initiative, one voted for holding the payline, and two voted to wait for more FY 2000 Budget information to be available. With this indication of support, Dr. Gorden said that the staff would move forward with this new initiative.

VII. Division Director's Reports

A. Division of Extramural Activities

Dr. Stolz began his report by discussing the NIH requirement that all clinical studies supported by the NIH include an appropriate representation of women and minorities so that the results of the studies would be applicable to all sectors of the U.S. population.

He described how the initial review group has the responsibility of assessing whether or not the applicant has adequately conformed to this requirement. In cases where the initial review flags the application as having problems in this regard, staff negotiates with the principal investigators for either clarification of the studies or modification of the studies to include appropriate numbers of minorities and women before the application can be funded.

He presented data from FY 1997 indicating that, among all competing applications funded, only a handful were found to have problems and that all were resolved by either additional changes in the sampling design of the study.

Discussion

Council members asked about assessments of outcomes of complying with the requirements to include minorities and women. There was concern expressed that in complying with the statutes, there could be an adverse impact on research or constraints on the type of research done. Council members asked if there were more published studies and quality clinical research coming from grantees or whether the constraint was inhibiting these studies. Dr. Stolz said that he was not aware of the existence of data bearing on this question.

A Council member pointed out that the Institute was getting process compliance, but not necessarily outcome compliance. Dr. Stolz said that about 70,000 subjects a year, either minorities or women, were included in studies funded by NIDDK.

A Council member said that she would be interested in the impact of the inclusion of minorities and women in relationship to burden of disease and that this information would be valuable as a measure.

Career Awards

Dr. Stolz continued his report with a description of the K awards made by the NIDDK. He said that after 1 year, there has been a large increase in the numbers of applications and awards. Dr. Stolz pointed out that about 70 to 80 K08s would be funded. He said that the K23 had a lower award rate than the other Ks.

Discussion

Council members were pleased with the K23 awards, but expressed some reservations about the review of the applications. Primarily, they were concerned about the expertise in patient-oriented research on the study sections. Since developing an application for patient-oriented research differed from other applications, Council members suggested that the Institute run workshops on developing these applications. Dr. Stolz pointed out that the K30 award that was administered by the NHLBI was a mechanism for funding universities to help them to develop courses on patient-oriented research.

Council members pointed out that Institute staff narrowly defined the K23 award. It was pointed out that there had been a shift from applicants applying for the K23 to the K08 just by the definition of whether they were involved in direct and ongoing contact with patients in their research or whether they were using a patient database. It was pointed out that this narrow targeting of the K23 would limit applicants since there was emphasis on research using large databases rather than doing patient by patient studies.

A Council member described a survey of their house staff interested in patient research and 25 percent were interested in health services research and 25 percent were interested in basic science research. He found the smaller numbers of applications for the K23 when compared with those coming in for the K24, was disturbing since both awards were announced at the same time. Council members recommended that analysis of the reviews of the K23 and K24 applications to explain the disparity between the two.

Council members also discussed the mentor pool as important in the successful development of applications for both the K23 and the K08. One Council member pointed out that it would take a while to build a cadre of sufficiently trained and accomplished mentors to help the potential applicants put together a competitive application for the K23.

Small Grant Program

Dr. Stolz reported on the small grant program as a supplement for the K08 grants for their last 2 years, and announced that 25 applications came to this Council for approval with 76 percent of these applications receiving scores of 200 or better. He pointed out that these were preliminary data.

B. Division of Diabetes, Endocrinology, and Metabolic Diseases

Dr. Eastman gave the Division report and began by reminding the Council members about the report that Council member Dr. C. Ronald Kahn had given at the previous meeting about the recommendations from the Diabetes Research Working Group (DRWG). He reported on the recommendations of the DRWG that were being implemented by the Division. One recommendation was to initiate a study of genetics of diabetes and complications, and he said that a taskforce had been assembled to address this recommendation. Another recommendation, to establish a national diabetes trial network, had been implemented by assembling a cooperative research clinical group to establish a stable high quality structure necessary to conduct efficient clinical trials in diabetes. He also described the status of the task force's efforts on studying susceptibility markers in diabetes. He said a goal was to identify individuals at risk for diabetes with the object of delaying the development of diabetes. He described other taskforces working on a variety of diabetes issues. He reported that there were a number of FY 2000 issues that were already being implemented as well as an additional list of initiatives developed to be responsive to the DRWG plan.

Discussion

Dr. Gorden commented that a plan was in place to implement these projects in an uncertain Budgetary picture.

C. Division of Digestive Diseases and Nutrition

Dr. Hoofnagle gave the Division report and began by introducing a new staff member, Jose Serrano, M.D., Ph.D. who would be administering the liver and pancreas grant programs in the Division. He described an RFA on Hepatitis C that would result in 20 grants being made for $6 million, with NIDDK contributing $1.5 million and the rest coming from other institutes. He described a 7-year clinical trial on the treatment of hepatitis C with long-term anti-viral therapy for patients with resistance to conventional therapy.

He said that the NIDDK would be sponsoring the 6th International Symposium on Hepatitis C Virus and Related Viruses that would be the first such symposium not sponsored by the pharmaceutical industry. Over 300 abstracts had been received with over 800 people expected to attend. He pointed out that hepatitis C was more severe among African Americans and the survival rate was lower. He said that the symposium would be reviewing all the data and determining which research directions would be most fruitful.

Dr. Hoofnagle described the Study of Health Outcomes of Weight-Loss (SHOW) trial as a major obesity program initiative. He said this trial was a long-term study of the health effects of weight-loss as a treatment for obesity. He said it was planned also to address the issues of obesity with an RFA on ancillary studies on patients in the SHOW trial. He also described an RFA on prevention of obesity in special populations in which 90 applications had been received.

Discussion

Council members were concerned that if there were a serious constraint in funds, it would not be possible to go forward with the initiatives without dropping the payline.

Dr. Gorden explained that it was important to separate the initiatives from the Budget, as there would always be other pressures such as Congressional directives. He pointed out that it was important to prioritize the initiatives so that the Institute could move rapidly when the funding for the Institute was known.

D. Division of Kidney, Urologic, and Hematologic Diseases

Dr. Briggs gave the Division report, and she began by describing initiatives and RFAs supported by the Division. Two of the RFAs she described were a large multi-institute initiative on surgical intervention for urinary incontinence and a study of the toxicity of iron and methods to remove iron from the body.

She described a workshop planned on utility of rat and mouse models for susceptibility for diabetic nephropathy as an important aspect to human studies in identifying the genes involved. She said another planned workshop was on learning more about patients in end-stage renal disease. She described the congressional instruction to strengthen the Division's program in prostate biology. She also described a consortium to provide the infrastructure for small clinical trials for vascular access and nutrition in dialysis patients.

VIII. Consideration of Review of Grant Applications

Summary Table 1

Applications Taken to Council
All Applications by Budget Category	Scored Applications	NRFC Applications	Deferred Applications	No Action	Totals
Regular Research* (P01, R01, R37, R41, R42, R43, R44)	769	-	-	-	769
Other Research* (R03, R13, R15, R21, K01, K02, K08, K23, K24)	208	1	-	-	209
Centers (P30, P50)	36	-	-	-	36
Training* (T32)	22	-	-	-	22
MBS (S06) DK Secondary only	-	-	-	-	-
Totals	1,035	1	-	-	1,036

Summary Table 2

Applications Taken to Council
Applications by Support Mecanism	Scored Applications	NRFC Applications	Deferred Applications	No Action	Totals
Program Projects (P01)	7	-	-	-	7
Research (R01)	654	-	-	-	654
MERIT (R37)	3	-	-	-	3
STTR (R41) (R42)	6 1	- -	- -	- -	6 1
SBIR (R43) (R44)	86 12	- -	- -	- -	86 12
Small Grants (R03)	39	-	-	-	39
Conferences (R13)	45	-	-	-	45
AREA (R15)	10	-	-	-	10
Exploratory/Develop. (R21)	3	-	-	-	3
Education Projects (R25)	3	-	-	-	3
Careers (K01) (K02)	19 1	- -	- -	- -	19 1
CIA (K08)	43	-	-	-	43
PSA (K23) (K24)	26 16	- -	- -	- -	26 16
Core Centers (P30) Specialized Centers (P50)	25 11	- -	- -	- -	25 11
Training (T32)	22	-	-	-	22
MBS (S06) DK Secondary only	-	-	-	-	-
Totals	1,036	-	-	-	1,036

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)	7	-	-	434	441
STTR Phase I (R41)	-	-	-	9	9
STTR Phase II (R42)	-	-	-	1	1
SBIR Phase I (R43)	-	1	-	90	91
SBIR Phase II (R44)	-	-	-	11	11
Small Grants (R03)	-	2	-	-	2
Conferences (R13)	-	2	1	1	4
AREA Grants (R15)	-	-	-	7	7
Exploratory/Developmental (R21)	-	-	-	2	2
Core Centers (P30)	-	1	-	-	1
CIA (K08)	-	1	-	-	1
MIAP-OP (K24)	-	1	-	-	1
Totals	7	8	1	555	571

IX. Adjournment

Dr. Gorden thanked the Council members for their attendance and advice. There being no other business, Dr. Gorden adjourned the 150th meeting of the NIDDK Advisory Council on June 2, 1999, at 12:05 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 and Digestive and
Kidney Diseases Advisory Council