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February 2000 - Meeting Minutes

Department of Health and Human Services
Public Health Service
National Diabetes and Digestive and Kidney Diseases
Advisory Council
February 2-3, 2000

I. Call to Order and Introductions of the Acting Director, NIH, and the Director, NIDDK

Mr. L. Earl Laurence introduced the Acting Director, NIH, Dr. Ruth Kirschstein. She began her remarks by giving an overview of the course set by former NIH Director, Dr. Harold Varmus. She pointed out that the Congress had been generous to the NIH in the past and especially recently, and that in light of some communities' skepticism that the NIH could appropriately use the funds, the NIH had to demonstrate that it was employing excellent stewardship of those funds to accomplish its mission.

Dr. Kirschstein introduced Dr. Allen Spiegel as the new Director of NIDDK, and gave a brief summary of his background.

Dr. Spiegel then called to order the 152nd NDDK Advisory Council meeting on February 2, 2000, at 8:35 a.m.

A. Attendance

Council Members Present (See Attachment A)
Dr. Edward J. Benz, Jr.
Dr. D. Montgomery Bissell, Jr.
Dr. Judith Bond
Dr. Jeffrey I. Gordon
Hon. Levan Gordon
Dr. Daryl K. Granner (Ad hoc)
Ms. Ruby R. Haughton
Dr. Edward W. Holmes
Dr. John McConnell
Dr. Kristen McNutt
Dr. Eric G. Neilson
Dr. Daniel Podolsky
Dr. Daniel Porte
Dr. Sandra Puczynski
Dr. Joseph T. Spence (Ex Officio)
Dr. Ming-Jer Tsai
Dr. Dana Weaver-Osterholz
Dr. Robert W. Schrier
Dr. Rena R. Wing

Council Members Absent:
Dr. C. Ronald Kahn
Ms. Genevieve R. Jackson

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 portion of the meeting. Attendees included the following:

Ann Albright, American Diabetes Association Syed Amir, CSR David Badman, NIDDK Jeff Ball, NIDDK Michelle Barnard, NIDDK Pamela Belton, NIDDK Johnny Bladen, NIDDK Sharon Bourque, NIDDK Josephine Briggs, NIDDK Ben Burton, NIDDK Francisco Calvo, NIDDK Syd Carter, NIDDK Dolph Chianchiano, National Kidney Foundation Cheryl Chick, NIDDK Paul Coates, Office of Dietary Supplements, NIH Catherine Cowie, NIDDK Charlenia Daniels, NIDDK Florence Danshes, NIDDK Jane DeMouy, NIDDK Nancy Dixon, NIDDK Jackie Dobson, NIDDK Richard Eastman, NIDDK Linda Edgeman, NIDDK Gayla Elder-Leak, NIDDK Bill Elzinga, NIDDK Jay Everhart, NIDDK Richard Farishian, NIDDK Ned Feder, NIDDK Carol Feld, NIDDK Bill Foster, NIDDK Judith Fradkin, NIDDK Sandy Garfield, NIDDK John Garthune, NIDDK Janet Gregory, NIDDK Colleen Guay-Broder, NIDDK Ann Hagan, NIDDK Frank Hamilton, NIDDK Joan Harmon, NIDDK Mary Harris, NIDDK Maureen Harris, NIDDK Barbara Harrison, NIDDK Shirley Hilden, CSR Trudy Hilliard, NIDDK Gladys Hirschman, NIDDK Jay Hoofnagle, NIDDK Tom Hoya, Blue Sheet Van Hubbard, NIDDK Donna Huggins, NIDDK Desiree Johnson, NIDDK Ephraim Johnson, NIDDK Kieran Kelley, NIDDK Mary Beth Kester, NIDDK

M. A. Khan, CSR Paul Kimmel, NIDDK Krish Krishnan, CSR John Kusek, NIDDK Maren Laughlin, NIDDK L. Earl Laurence, NIDDK Kim M. Law, NIDDK Brenda Lig, PNA Barbara Linder, NIDDK Helen Ling, NIDDK Billie Mackey, NIDDK Michael Mawby, American Diabetes Association Denise Manouelian, NIDDK Ronald Margolis, NIDDK Dan E. Matsumoto, NIDDK Ken May, NIDDK Catherine McKeon, NIDDK Barbara Merchant, NIDDK Carolyn Miles, NIDDK Barbara Minor, NIDDK Marjani Mitchell, NIDDK Neal Musto, NIDDK Denise Payne, NIDDK Aretina Perry-Jones, NIDDK Judith Podskalny, NIDDK Sharon Pope, NIDDK K. Radman, NIDDK Alice Robinson, NIDDK Charles Rodgers, NIDDK Mary Kay Rosenberg, NIDDK Lakshmanan Sankaran, NIDDK Sheryl Sato, NIDDK Paula Skedsvold, NIH, OD M. James Sherbenske, NIDDK Jose Serrano, NIDDK Angela Sharpe, Consortium of Social Sciences Assocs. Elizabeth Singer, NIDDK Philip F. Smith, NIDDK Gloria Snowden, NIDDK Jane Spencer, NIDDK Robert Star, NIDDK Walter Stolz, NIDDK Tommie Sue Tralka, NIDDK George Tucker, NIDDK Nola Whitfield, NIDDK Shan S.Wong, NIDDK Susan Yanovski, NIDDK Rita Yeager, NIDDK Elaine Young, Juvenile Diabetes Foundation 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, February 2, 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, February 3, 2000, from 8:30 a. m. until 9:00 a.m. for review, discussion, and evaluation of grant applications, and open from 9:00 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. Spiegel asked for consideration of the dates listed below for future NDDK Advisory Council meetings.

• May 31-June 1, 2000
• September 20-21, 2000
• 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 four new Council members, Drs. Edward J. Benz, Jr., Edward W. Holmes, and Sandra Puczynski and the Honorable Levan Gordon and one ad hoc Council member, Dr. Daryl L. Granner. He introduced the new Executive Officer of NIDDK, Ms. Barbara Merchant.

Dr. Spiegel gave a brief overview of his career at the NIH. He said that the NIDDK constituencies and the NDDK Council were key to the success of the Institute's plans to move forward. He would emphasize two themes: one was the connection between basic and clinical research, and the other theme was to take advantage of recent developments in science, such as the mapping of the human genome, imaging technology, new animal models, and bioinformatics. He said that the Congress would not be satisfied unless more innovation was planned with the additional increase in funds given to the NIH. Although investigator-initiated grants were historically key to the Institute's portfolio of grants, it was important to invest in other research areas such as DNA array technology and clinical trials. He said that one of his goals was to move translational research forward.

Another issue Dr. Spiegel noted was loan repayment by clinical scientists and physician researchers as an incentive to enter and stay in a research career. He said that the development and retention of outstanding new investigators was an NIH-wide problem and would carry forward the Council's recommendations on this issue.

He said that he would ask the Council's advice on NIDDK's participation in a number of trans-NIH projects, and he gave as examples the zebrafish project and the mammalian gene collection.

He pointed out that measurable outcomes were important. He said a step-by-step monitoring assessment of each of the grant mechanisms was planned, and he gave as examples the SBIR mechanism and training and career grant awards. He said that the National Institute on Deafness and Other Communication Disorders had done a study to determine which training awards had resulted in investigators obtaining R01 awards and becoming independent investigators. He said he was interested in the Council members' advice on framing a study to be done on the subject of training and career grants.

He asked the Council members' advice on the NIDDK planning process and whether they found the Institute's planning documents useful.

Discussion

A Council member said that the Council members had expertise to assess both basic and clinical science; however, he said there was a schism between basic science and translation into cures and prevention. He said the assessment of impact and what made a difference was needed, and Council members could assess the ends, but to bring these together needed creative ideas. Dr. Spiegel pointed out that the Council members were conversant assessing the scientific impact of a given area of research. He said, however, there were barriers that blocked the translation of basic advances into clinical advances, and that the Institute wanted to facilitate the translation. He pointed out that clinical trials relating to orphan diseases were not always profitable and thus would not be attractive to industry, and they needed the Institute's attention.

V. Discussion of the NIDDK FY 2000 Budget

Mr. L. Earl Laurence reported on the budget and accomplishments in FY 1999. He said FY 1999 had been a good year, with increased funding and growth in numbers of grants in several mechanisms. He elaborated on the status of the FY 2000 appropriation, pointing out that the NIH had a significant increase in funding of $2.3 billion or a 14.4 percent increase. For the NIDDK there was an increase of $150 million or a 15.1 percent increase.

He described the impact that Congressionally mandated delayed obligations would have on some NIDDK grantees and the steps the Institute staff were taking to minimize this impact. He described the increase in the numbers of grants awarded over the past 3 years and the impact on the funding of new grants as the numbers of non-competing grants grew. He said this would result in fewer grants terminating in FY 2000. He said the payline for FY 2000 would be at the 21st percentile and 23rd percentiles for competing renewal and new grants respectively, a drop from the 25th percentile and 27th percentile of last year, and he described the difference between paylines and success rates, pointing out that the success rate last year had been 33 percent and this year was expected to be 31 percent.

Discussion

A Council member expressed concern about how the funds were allocated and the ups and downs in funding that made it difficult to plan long-term initiatives. He pointed out that there had been a drop in the number of new R01s despite an increase in funds, and he asked what factors had been involved. Dr. Spiegel responded that it related to the cyclical nature of the grant mechanism. He said that with 3 previous good years and with more R01s pouring into the cycle, and a 4th year that was a good year, there would not be an exodus of grants to balance the numbers of incoming grants. He offered, as a remedy for this problem, the use of short-term pilot and feasibility grants and other mechanisms that would not encumber large amounts of funds in future years and thus give greater flexibility. He said it was necessary to continue to make the case for the R01 mechanism and also to argue that investment was needed in research infrastructure.

Council members commented that Congress paid attention to voters and that voters did not understand what the NIH did, so they said it was important that scientific advances be moved toward curing diseases so people would know that research had pay offs. They said that otherwise the research dollars would not continue to flow. They pointed out that it was necessary to articulate the value of science. Dr. Spiegel responded that it was the obligation of scientists to make the case. He said that polls had shown that people supported science, and that the case had to be made for the relevance to public health.

Council members expressed concern about the practical realities of the budget since it lacked flexibility and much of the budget was committed to research project grants. They pointed out the impact of flexibility on strategic planning and the implementation of plans. Council members recommended the development of a strategic planning advisory group composed of Council members and some business and financial people. It was pointed out that some institutes had done remarkable things with flexible dollars, and they recommended that the Institute re-define its strategic planning process with an emphasis on generating sources of funds to implement new initiatives. It was suggested that Congressional set-asides can become flexible dollars at a later time. Dr. Spiegel responded that it was fortunate the Institute had an increase in budget. He pointed out that if the increases continued, there might be enough funds to continue supporting the base of investigator-initiated research and to have flexible funds for new initiatives as well. He said he would welcome a group to give advice, and he said this needed to proceed in parallel with assessment of the planning process.

Mr. Laurence pointed out that the research project budget already included a significant percentage of the multi-center clinical trials. He also said that the Institute had recently developed a new major clinical trial using the contract mechanism; however, he pointed out that contracts needed a long lead time to put in place. He said these lead times were important for FY 2001 plans and initiatives.

Council members recommended that some funds be used for core projects rather than individual awards. They recommended that each core or program be looked at individually, and that if it appeared to have a good return on the investment, then it should be done. They wanted to create a culture where innovation would be promoted starting with the investigator and also involving the study sections. They said it was the job of the Council to help define and provide for infrastructure developments.

Dr. Spiegel described several trans-NIH research projects involving newer technology such as a high through-put genotyping facility with an informatics component and the human and mouse full length mammalian gene collection projects that the NIDDK did not participate in with other institutes. He asked the Council members to consider whether it would be in the best interests of NIDDK to support the trans-NIH effort. He said his inclination was that NIDDK should contribute to these projects in order to meet NIDDK-supported researchers' needs.

Council members pointed out that, from the Single Nucleotide Polymorphisms project, genes were being found that at first were not appreciated as having an impact on diabetes, and that diabetes, as a core responsibility of NIDDK, would be helped by these trans-NIH investments. They pointed out that collaborations with other institutes in clinical trials had led to broader results. They expressed concern about NIDDK later being able to withdraw from collaborative projects once they started participating.

Dr. Spiegel described several projects for which NIDDK and NHLBI were either collaborating or co-funding.

Council members expressed concern about a shortage of post-doctoral candidates from the U.S. They recommended training more graduate students from this country to have enough potential candidates from this country for post-doctoral positions. They pointed out that post-doctoral candidates from other countries found jobs and stayed in the U.S. Dr. Spiegel responded that the average period required for graduate training had increased to longer than 7 years. He said that there was not a shortage of graduate students or post-doctoral students, but that the foreign post-doctoral students found jobs because they were willing to work for low wages. He said the problem was that they were unable to find jobs after the post-doctoral training.

VI. Reports and Discussions

A. Review of the SBIR/STTR Program

Ms. Joanne Goodnight, SBIR/STTR Coordinator for the NIH, described the unique features of the Small Business Innovative Research (SBIR) and Small Business Technology Transfer Research (STTR) programs. She said that 2.5 percent of the NIH extramural research budget was reserved for the SBIR program and 0.15 percent for the STTR program. She said the program was initiated under the 1982 Small Business Innovation Development Act and had four goals: to stimulate technological innovation; to use small businesses to meet federal R and D needs; to foster participation by women, minorities and disadvantaged individuals in technological innovation; and to increase private commercialization of projects funded through federal R and D funding.

She described the three phases of the programs as: Phase I (feasibility study), Phase II (R and D stage or prototype development), and Phase III (commercialization stage) without SBIR or STTR funding. She described the requirements for the programs, pointing out that the awards could either be grants or contracts, and she described how the applications were reviewed. She gave the numbers of awards for the past year and characterized them according to whether the PIs were new to the program or had had previous awards, and she described the success rates of the awards. She explained that the NIH was interested in tracking projects and had a pilot study going to assess the program.

Discussion

Dr. Spiegel said that commercialization received from the grants was an obvious way to track the program. Ms. Goodnight said they were looking at commercial sales, inventions, patents, publications, and developing research tools for the community at large as determinants of success.

Council members were interested in the development of the tracking system and also asked about strengths and weaknesses in the SBIR program. They commented that a system was needed for the companies to report back to the NIH in the Phase III stage. Ms. Goodnight responded that the peer review committee members during the reviews often commented on the innovative aspects of the applications, and she pointed out that this was a strength of the program as the larger companies often would not do the R and D that the small companies did. She said each of the projects had an end product. She commented that the Patent Trademark Office had been requested to add to their forms a question regarding whether government funding had been used.

B. Continued Discussion of Human Resource Issues in Research

Dr. Spiegel introduced the topic by recapping the discussion from the previous Council meeting.

Dr. Stolz reported on the NIH efforts to track new investigators after discontinuing the FIRST Award (R29). He reported that there was concern about bringing new people into the pipeline and that the Institute would undertake a study with four objectives: (1) to identify new investigators, (2) to look retrospectively at where they had trained and what enabled them to be successful as new investigators, (3) to determine the relative effectiveness and efficiency of the mechanisms used by the Institute to support training and career development, and (4) to determine the resources needed for getting the right numbers of people in the right field at the right time. He defined a new investigator as someone who had not held an R01 or comparable grant. He said that Form 398 asked new investigators to identify themselves on the first page of the application and that study sections were asked to use slightly different review criteria in evaluating applications from new investigators. He proposed putting a tracking system in place using what information was available from the data systems at the NIH to determine the turnover rate among investigators. He said current estimates indicate that the half-life of investigators was 6 to 8 years.

Discussion

Dr. Spiegel pointed out that there was a peak in new investigators being supported in 1994 and then a drop below 1987 levels. He said that there were two possibilities for this, (1) the number of applicants was the same, but they were not competing as well and (2) the number of applications was falling.

Council members pointed out that new investigators would come in with one application while established investigators would come in with several.

Council members asked about the elimination of the FIRST Award (R29) and the impact on new investigators. They said that after five Council rounds there should be some analysis, and indicated their concern with examining the data "sooner rather than later," as after 2 to 3 years they did not want to find out that there was a 50 percent drop off. Dr. Stolz pointed out that there had not been a clean break in discontinuing the R29 for a variety of reasons such as R29 applications that had been amended a couple of times were still considered an R29. He said that each NIDDK division had tracked each applicant.

Council members asked if there was an analysis of physicians vs. Ph.D. applications. Also, they suggested tracking principal investigators and where they were.

Dr. Spiegel suggested doing an analysis of publications from new investigators.

Council members pointed out that it was difficult to determine publications from the names. They also pointed out that this would not have information on why people were dropping off. Also, they asked about analyses of career development programs.

VII. Scientific Presentation by Dr. Bruce Spiegelman: Molecular Control of Adipogenesis and Metabolism Through the PPAR Gamma System

VIII. Division Directors' Reports

A. Division of Extramural Activities

Dr. Stolz gave the Division report. He described the operating procedures of the Council and discussed the yearly review of these procedures by the Council members. He requested that the Council members peruse the procedures and inform him of any changes that they would consider helpful to the Council members.

B. Division of Diabetes, Endocrinology and Metabolic Diseases

Dr. Eastman gave the Division report, and began his report by describing a conference held in Miami January 9-10, 2000, on the future directions in prevention of type 1 diabetes. He gave the highlights of the meeting and said that the conference addressed biostatistical, ethical, logistical, and economic issues related to intervening in the natural history of type 1 diabetes. He pointed out for the genetically at risk, the appearance of autoantibodies could be used as an end point and surrogate measure for diabetes in a clinical trial. He said the group recommended focusing on prevention interventions with new-onset diabetes patients. He said that proposed therapies were discussed and that the next step was to organize a network to conduct trials and to determine what agents were ready to be tested in populations of newly diagnosed patients.

Dr. Eastman described several projects and meetings relating to endocrinology. He described an article that appeared in the Journal of the American Medical Association that showed that women on long-term estrogen and progesterone therapy were at higher risk for breast cancer. He said the use of estrogen and progesterone for menopause required striking a balance between preventing osteoporosis and heart disease and the increased risks of endometrial and breast cancer. He announced a meeting on selected estrogen receptor modulators (SERMs) on April 26, 2000, that offered the possibility of preventing osteoporosis without increasing the risk of stimulation through other estrogen receptors. He said that the emerging field of selected androgen receptor modulators (SARMs) would be addressed as well. He announced a consensus conference on osteoporosis to be held March 27, 2000, and described other meetings sponsored by the Division.

Discussion

Dr. Spiegel described how the $150 million given to the NIH from the Congress 3 years ago for research relating to type 1 diabetes had been allocated. He said that proposals from other NIH institutes had been requested for using the remaining funds. He said they had proposals in hand for $60 million and would rely on an outside group to advise the Institute.

He described a large science effort in which funds were to be offered to groups of scientists that would aggregate around some specific theme or topic. He gave examples such as determining everything about cell signaling in two model cell types, the b-lymphocyte with chemotaxis as the end point, and the cardiac myocyte with contractility as an end point. He said he had recommended extending this plan to the beta cell with insulin secretion as a logical end point.

C. Division of Digestive Diseases and Nutrition

Dr. Hoofnagle gave the Division report and began by announcing that former Council member, Dr. Barbara Rolls, had published a new book on weight control.

He reported on a meeting on health disparities in hepatitis C, the most common cause of chronic liver disease in the U.S. affecting 1 to 2 percent of Americans. He reported there were racial and ethnic differences in the prevalence of the disease, the clinical course, outcome, and rate of complications of the disease. He reported on the results of a Division-sponsored workshop to evaluate the current information on racial differences in hepatitis C. He said there were over 100 participants, with many minorities among the participants. He said NHANES data showed that the prevalence of hepatitis C antibodies found in African Americans was two to three-fold higher than in Caucasians; he said the risk of acquiring hepatitis C was similar among the various races. He reported that while the disease was rare in childhood, its onset in African Americans was earlier than in Caucasians with almost 10 percent of African Americans infected with hepatitis C by the age of 40 to 45. He pointed out that not everyone who had antibodies to hepatitis C had a chronic infection, and about 25 percent of infected people recovered on their own. He said that while 68 percent of antibody-positive non-Hispanic whites were viremic, the percentage in African American men was 86 percent.

He described the six genotypes of hepatitis C with the first three the most common in the U.S. He pointed out that almost all African Americans had genotype 1 which was more resistant to therapy. Also, genotype 3 was almost absent among African Americans. He said that, while African American adults accounted for 12 to 13 percent of the U.S. population, they accounted for 22 percent of the cases of chronic hepatitis C. He said that biopsies showed the disease in African Americans to be milder and progression to development of cirrhosis rates were lower in African Americans than in Caucasians.

He described a study of injection drug users from the inner city of Baltimore in which 95 percent of the population were African Americans that had been followed since 1989. This study showed that progression to end-stage liver disease was slower in African Americans than in Caucasians but that the prevalence of infection was two times higher in African Americans.

He said that complications of hepatitis C were cirrhosis of the liver and hepatocellular carcinoma, and therapy for hepatitis C was interferon and the combination of interferon with ribavirin.

For the future, he said a study was needed of African Americans with a careful analysis of the characterization of these patients into different patterns and the correlation of these patterns with virology, immunology, and genetic studies to determine why there were these differences. He said that only with this knowledge could reliable recommendations be made concerning management and therapy.

Discussion

A Council member asked whether the data for sexual transmission of hepatitis C were still controversial. Dr. Hoofnagle said it had not been defined; however, chronic patients usually had had the disease for 20 years so it was difficult to trace it to the source, but with acute cases of hepatitis C, sexual exposure accounted for 20 to 30 percent of the cases. Dr. Spiegel said the controversy came from the era of tainted blood where hemophiliacs and others had hepatitis C, so these were used as examples that the disease was not sexually transmitted. Dr. Hoofnagle said that it was rare for a married partner to acquire hepatitis C from his or her partner with chronic hepatitis C. He said that among the acute cases, they usually had sexual relations with someone who had had hepatitis C, and he said that it might be due to other sexually transmitted venereal diseases that promoted the transmission because of open lesions, etc.

D. Division of Kidney, Urologic, and Hematologic Diseases

Dr. Briggs gave the Division report, and began by describing a breakthough in the autosomal dominant disease, polycystic kidney disease (PKD), an active area in the Division's portfolio. She explained how products were produced from two genes, PKD1and PKD2, but that it was unclear how defects in these gene products led to the disordered regulation of epithelial cell growth characterizing PKD. She described how a young investigator at the California Institute of Technology, Dr. Maureen Bass, discovered a gene, LOV-1, in the male round worm (C. elegans) that affected the reproductive function in the worm. The gene encoded a membrane protein with two blocks of homology to human polycystins (which were products of the PKD loci, PKD1 and PKD2). Thus, LOV-1 was the closest C. elegans homologue of PKD1. She pointed out that C. elegans was the most complex organism to date whose genome was fully sequenced, and that Dr. Bass had identified the homologue so it would be possible to identify other interacting proteins and to untangle their functions by genetic studies.

Dr. Briggs reported on other issues that had led to consideration of a national kidney disease education program that included: evidence for a kidney disease epidemic, what preventive measures could be taken, and the NIDDK role. She pointed out that kidney disease was frequently silent until the kidneys failed and gave statistics about end-stage renal disease (ESRD) and projections of numbers of future needs for dialysis and kidney transplantation and the costs of these. She said minority populations were most heavily impacted.

She described preventive strategies that could be taken that included: increasing organ donation rates, prevention of late diagnosis of ESRD (particularly in minority populations), primary care physicians' awareness of kidney disease, and greater involvement and partnering with national kidney societies.

Discussion

Council members recommended extending partnerships with lay advocacy groups and also recommended that an Institute person serve as a liaison with lay groups. They said education was key in the prevention of kidney disease. Also, they said that data were needed on the Hispanic populations because this group was the fastest growing population and was as pre-disposed to kidney disease as the African American population. Dr Briggs reported that data on the Hispanic population were being collected. Dr. Agodoa said there had been under-counting of the Hispanic population, but that was being remedied.

Dr. Eastman said that it would be good to partner with other NIH education programs to coordinate the messages going out.

Council members were concerned about primary care physicians not referring patients to nephrologists until late in the disease state. They said that there was a large segment of the population that was not being exposed to information about kidney disease, and they recommended changing the behavior of primary care physicians. They said it had become an economic issue, and they recommended that NIDDK focus on programs and outcome data that would provide the evidence to make this economic assessment. They pointed out that cost containment was impacting on clinical care, and it was important that the NIDDK provide the data to change health maintenance and policy of health funding.

Dr. Spiegel said that to mount an effective education effort, one that would change behavior, evidence of what was effective was needed. He recommended gathering evidence with this education campaign to broaden the message to other groups.

Council members said that in many communities, primary care physicians were a luxury and that nurse-practitioners and the American Academy of Emergency Medicine needed to be a part of the group targeted since much of the care was given by emergency room physicians and nurse-practitioners.

Council members said that morbidity and mortality rates relative to kidney disease were available, and that NIDDK had a road map from diabetes on how to reach people through lay organizations such as the Juvenile Diabetes Foundation, the American Diabetes Association, and other organizations. They pointed out that these organizations knew how to reach physicians, nurse-practitioners, and the general public with concise messages. They pointed out that the National Kidney Foundation had been sponsoring programs in various cities where they had been screening people for high blood pressure, diabetes, etc. Also, a Council member pointed out that the United States Renal Data System (USRDS), funded by NIDDK, clearly told where the patients came from through zip code data, thus offering potential for targeted prevention programs.

Council members pointed out that an important clue for picking up ESRD patients early with potential intervention therapies was albuminuria. They recommended a major focus on blood pressure control. Council members recommended a partnership with the Institute of Medicine as an evidence-based approach.

Council members raised the issue of organ donation and asked if the NIDDK could do anything about increasing organ donation. They pointed out that efforts to increase organ donation had been slow and that statistics showed that little progress has been made. Dr. Briggs said there were small projects funded in minority organ donation, but the projects were fragmented among institutes. Dr. Spiegel pointed out that Dr. Shalala, DHHS Secretary, had tried to raise visibility in the area of organ donation.

IX. Consideration of Review of Grant Applications

Summary Table 1

Applications Taken to Council
All Applications by Budget Category	Scored	NRFC	Deferred	No Action	Total
Regular Research * (P01, R01, R29, R37, R41, R42, R43, R44, U01)	706	-	1	-	707
Other Research * (R03, R13, R15, K02, K08)	172	2	-	-	174
Centers (P30, P50)	6	-	-	-	6
Training * (T32)	6	-	-	-	6
MBS (S06) DK Secondary only	-	-	-	-	-
Totals	890	2	1	-	893

* Includes both DK primary and secondary.

Summary Table 2

Applications Taken to Council
Applications by Support Mechanism	Scored Application	NRFC Applications	Deferred Applications	No Action	Totals
Program Projects (P01)	17	-	-	-	17
Research (R01)	589	-	1	-	590
MERIT (R37)	2	-	-	-	2
STTR (R41) (R42)	1 1	- -	- -	- -	1 1
SBIR (R43) (R44)	76 20	- -	- -	- -	76 20
Small Grants	19	-	-	-	19
Conferences (R13)	37	-	-	-	37
AREA (R15)	11	-	-	-	11
RDDP (R18)	2	-	-	-	2
Exploratory/Develop. (R21)	21	-	-	-	21
RR Research Project (R24)	6	-	-	-	6
Education Projects (R25)	4	-	-	-	4
Careers (K01)	13	-	-	-	13
Academic/Teacher Award (K07)	14	-	-	-	14
CIA (K08)	16	-	-	-	16
PSA (K23) (K24)	16 13	1 1	- -	- -	17 14
Core Centers (P30)	6	-	-	-	6
Training (T32)	6	-	-	-	6
MBS (S06)	-	-	-	-	-
Totals	890	2	1	-	893

Summary Table 3

Applications Not Taken to Council
Categories by Support Applications	Bottom-Tier Applications	NRFC Applications	Excluded by Institute Staff	Non-Comp	Total Applications
Program Project (P01)	-	1	-	-	1
Traditional Research	4	2	-	338	344
STTR Phase I (R41)	-	-	-	9	9
STTR Phase II (R42)	-	-	-	1	1
SBIR Phase I (R43)	-	-	-	70	70
SBIR Phase II (R44)	-	-	-	3	3
Small Grants (R03)	-	1	-	-	1
Conferences (R13)	-	1	-	-	1
AREA Grants	-	-	-	4	4
Academic/Teacher Award	-	-	-	16	16
CIA (K08)	-	-	-	2	2
Exploratory/Developmental (R21)	-	1	-	12	13
RR Research Projects (R24)	-	-	-	1	1
Totals	4	6	-	456	466

X. Adjournment

Dr. Spiegel thanked the Council members for their attendance and advice. There being no other business, Dr. Spiegel adjourned the 152nd meeting of the NDDK Advisory Council on February 3, 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