February 7-8, 2001 - Meeting Minutes
Department of Health and Human Services
Public Health Service
National Diabeties and Digestive and Kidney Diseases
February 7-8, 2001
I. CALL TO ORDER
Dr. Spiegel called to order the 155th National Diabetes and Digestive and Kidney Diseases Advisory Council meeting on February 7, 2001, at 8:35 a.m. in Conference Room 10, Building 31.
COUNCIL MEMBERS PRESENT (See Attachment A)
Mr. David Baldridge
Dr. Edward J. Benz, Jr.
Dr. D. Montgomery Bissell,
Dr. Jose Caro
Dr. Jeffrey I. Gordon
Hon. Levan Gordon
Dr. Edward W. Holmes
Ms. Genevieve R. Jackson
Dr. Carolyn Kelly
Dr. John McConnell
Dr. Daniel K. Podolsky
Dr. Daniel Porte Jr. (Ex Officio)
Dr. Sandra Puczynski
Dr. Vicki Ratner
Dr. Robert W. Schrier
Dr. Joseph T. Spence (Ex Officio)
Dr. Ming-Jer Tsai
Dr. Rena R. Wing
COUNCIL MEMBERS ABSENT
Dr. C. Ronald Kahn
Dr. Kristen W. 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 sessions of the meeting. Attendees included the following:
|Syed Amir, CSR
David Badman, NIDDK
Jeff Ball, NIDDK
Michelle Barnard, NIDDK
Pamela Belton, NIDDK
Johnny Bladen, NIDDK
Sharon Bourque, NIDDK
Josephine Briggs, NIDDK
Molly Buehn, NIAID
Ben Burton, NIDDK
Francisco Calvo, NIDDK
Cheryl Chick, NIDDK
Catherine Cowie, NIDDK
Leslie Curtis, NIDDK
Charlenia Daniels, NIDDK
Florence Danshes, NIDDK
Jane DeMouy, NIDDK
GooJackie Dobson NIDDK
T. J. Dunlap, JIXLO
Linda Edgeman, NIDDK
Gayla Elder-Leak, NIDDK
William Elzinger, NIDDK
James Everhart, NIDDK
Richard Farishian, NIDDK
Ned Feder, NIDDK
Carol Feld, NIDDK
Judith Fradkin, NIDDK
Joanne Gallivan NIDDK
Sanford Garfield, NIDDK
Janet Gregory, NIDDK
Carol Renfrew Haft NIDDK
Deb Hamernik, CSR
Frank Hamilton, NIDDK
Robert Hammond, NIDDK
Joan Harmon, NIDDK
Mary Harris, NIDDK
Maureen Harris, NIDDK
Barbara Harrison NIDDK
Stewart Hill, NIDDK
Trude Hillard, NIDDK
Gladys Hirschman, NIDDK
Jay Hoofnagle, NIDDK
Karen Howard, NIDDK
Van S. Hubbard, NIDDK
Donna Huggins, NIDDK
|Stephen James, U. of Maryland|
Ann Jenkins, CSR
Desiree Johnson, NIDDK
Mary Beth Kester, NIDDK
Soonja K. Kim, CSR
Paul Kimmel, NIDDK
Kathy Kranzfelder, NIDDK
Krish Krishnan, CSR
John Kusek, NIDDK
Maren Laughlin, NIDDK
Kim M. Law, NIDDK
Todd Le, NIDDK
Monica Liebert, NIDDK
Gavin Lindberg, NIDDK
Barbara Linder, NIDDK
Billie Mackey, NIDDK
Denise Manoulian, NIDDK
Ronald Margolis, NIDDK
Winnie Martinez, NIDDK
Michael K. May, NIDDK
Catherine McKeon, NIDDK
Barbara Merchant, NIDDK
Carolyn Miles, NIDDK
Dave Miller, NIDDK
Barbara Minor, NIDDK
Neal Musto, NIDDK
Natalie Ochs, The Blue Sheet/FDC
Beth Paterson, NIDDK
Hazel Perez, NIDDK
Sharon Pope, NIDDK
Alice Robinson, NIDDK
Patricia Robuck, NIDDK
Paula Skedsvold, OD
Leonard Seeff, NIDDK
Jose Serrano, NIDDK
M. James Sherbenske, NIDDK
Elizabeth Singer, NIDDK
Philip F. Smith, NIDDK
Gloria Snowden, NIDDK
Robert Star, NIDDK
George Tucker, NIDDK
Shan Wong, NIDDK
Susan Yanovski, NIDDK
Rita Yeager, NIDDK
Charles Zellers, NIDDK
C. CONFLICT OF INTEREST STATEMENT (See Attachment B)
Dr. Robert Hammond 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. Dr. Hammond noted that this did not apply to "en bloc" actions.
Dr. Allen 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 7, 2001, 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 8, 2001, from 8:00 a. m. until 10:15 a.m. for review, discussion, and evaluation of grant applications, and open from 10:15 a.m. to 12 noon.
II. CONSIDERATION OF THE SUMMARY MINUTES OF THE PREVIOUSMEETING
The Council members present accepted the summary minutes of the September 2000 NDDK Advisory 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:
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 began his report by introducing four new members of Council: Mr. David Baldridge, Executive Director of the National Indian Council on Aging; Dr. Jose Caro, Vice President for Endocrine Research and Clinical Investigation at Eli Lilly Corporation; Dr. Carolyn Kelly, Professor of Medicine in the Division of Nephrology at the University of California, San Diego; and Dr. Vicki Ratner, an orthopedic surgeon in private practice and President and Founder of the Interstitial Cystitis Association. He introduced newly appointed NIDDK Division Directors, Dr. Robert Hammond, Director of the Division of Extramural Activities, Dr. Judith Fradkin, Director of the Division of Diabetes, Endocrinology and Metabolic Diseases, and Dr. Marvin C. Gershengorn as the Director of the Division of Intramural Research. Dr. Spiegel then asked the Division Directors to introduce newly appointed members in their Divisions. Dr. Hammond introduced Dr. Francisco O. Calvo, Chief of the Review Branch, Division of Extramural Activities (DEA). Dr. Fradkin then introduced Dr. Philip Smith as the Deputy Director of the Division of Diabetes, Endocrinology and Metabolic Diseases (DDEM). Also introduced from DDEM were two newly appointed program directors, Dr. Beena Akolkar, who will manage programs in immunology and genetics of type 1 diabetes and Dr. Carol Renfrew Haft, who will be heading the Adipocyte and Cell Biology program. Dr. Josephine Briggs, Director of the Division of Kidney, Urologic and Hematologic Diseases (DKUH), introduced Dr. Terry Bishop who will coordinate the Division=s training and career awards program and Dr. Paul Eggers who will have oversight of epidemiology programs in the Division. Dr. Jay Hoofnagle, Director, Division of Digestive Diseases and Nutrition (DDDN) introduced Dr. Patricia R. Robuck, who will head the clinical trials program of the Division, and Dr. Stephen James as Deputy Director of DDDN.
Dr. Spiegel announced the appointment of Governor Tommy Thompson as the new Secretary of the Department of Health and Human Services. He announced the appointment of Dr. Paul A. Sieving as Director of the National Eye Institute. With the departure of Dr. Gerald D. Fischbach, Director, National Institute of Neurological Disorders and Stroke, Dr. Audrey Penn was announced as the Acting Director. Dr. Spiegel noted the formation of a new institute at the NIH on biomedical imaging and bioengineering. The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve health by promoting fundamental discoveries, design and development, and translation and assessment of technological capabilities. A new National Center on Minority Health and Health Disparities has been created under the Director of the NIH, incorporating the former Office of Research on Minority Health with Dr. John Ruffin as head. Dr. Spiegel announced that Dr. Lawrence Agodoa will head the NIDDK Office of Minority Health Research Coordination, in addition to his program activities within DKUH.
Dr. Spiegel mentioned the celebration in 2000 of NIDDK=s past 50 years and directed attention to the publication of two booklets, AA New Century of Science, a New Era of Hope@ and ANIDDK Recent Advances and Emerging Opportunities.@
He described some of the budget time lines, pointing out that the Congressional Appropriation Hearings would be late this year because of the transition to a new administration. He announced that Congressman Regula of Ohio would head the House Appropriations Subcommittee while Arlen Spector would continue as head of the Senate Appropriations Subcommittee. He announced that the Congress had passed a special appropriation outside of the NIH budget for type 1 diabetes in the amount of $240 million, spread over fiscal years 01, 02, and 03. He said that the budget approved by the Congress for fiscal year 2001 resulted in an increase for NIDDK of 14.3 percent.
V. BUDGET REVIEW
Dr. Spiegel asked Dr. Griffin Rodgers, Deputy Director of NIDDK, to discuss the budget. Dr. Rodgers announced that the maximum salary payable through grants had increased from $141,000 to $157,000. He reported that the percentile for funding had been maintained at the 21(new competing grant applications) and 23 (competing continuation grant applications) percentiles for Fiscal Year 2000 and predicted 22 and 24 percentiles for Fiscal Year 2001. A total of 2,750 competing research project grants were funded for Fiscal Year 2000, representing an increase over the previous year of 180 grants. In Fiscal Year 2001, the NIDDK intends to pay an additional 220 grants. Dr. Rodgers described increases planned for centers grants, increased levels for research career programs, and for the new gene profiling resource initiative. He said that in Fiscal Year 2001 the NIDDK Division of Intramural Research will receive 9.6 percent of the total budget and the administrative costs of the Institute now represent 3.1 percent of the total budget. He described changes in policy for funding caps and receipt dates for program project grants and funding caps for center grants.
Dr. Rodgers stated that for the FY 2002 budget, the sense was that the NIH should fair well. He pointed out that the Congressional budget hearings will be both later and different this year from the past.
Council members inquired about center caps, whether the loan forgiveness would apply to individuals at the faculty level, and about salary support for the required 75 percent time commitment for principal investigators on K08 grants. They pointed out that once scientists receive K awards they are committed for 5 years. However, it is important to attract researchers and to retain the scientists in research through loan forgiveness before they receive the K awards. Dr. Spiegel responded that the NIH is grappling with these issues. Dr. Spiegel also described the use of the diabetes education program as an initiative in tribal middle and high schools as a tool for diabetes and science education.
Council members expressed interest in how they might offer input to the committees discussing these issues. Dr. Spiegel invited the Council members to contact him or Dr. Rodgers by email.
VI. UPDATE FROM TRANS-NIDDK PLANNING GROUPS
Council member Dr. Jeffrey Gordon began the updates of the Trans-NIDDK Planning Groups with his report on Stem Cells and Developmental Biology. He referenced articles appearing in Science and Nature as describing the first draft of the human genome, and he said it was important to not only find genes, but also to understand the function of these genes. He pointed out that a large number of the sequences that were identified in the analysis of expressed genes and hematopoietic cells had no known function. He said that one of the purposes of the planning effort focused on understanding stem cell biology in the tissues of interest to the NIDDK. He said that the role of the NIDDK is proactive in nature, to help direct, but not to micromanage the science. He said that to further the NIDDK role, the planning group identified the following aims: (1) to develop enabling technology and basic knowledge; (2) to launch research initiatives that connected diverse groups across the country; (3) to provide a means for ensuring that the fruits of these research initiatives, the biological reagents made from model organisms and from humans, would be available to the research community; (4) to ensure adequate training of scientists in stem cell research; and (5) to ensure adequate education of the public concerning the importance of this area of investigation.
Dr. Gordon identified seven working groups that had been assembled and he mentioned that a report had been developed with recommendations that the NIDDK should catalyze a nationwide effort to characterize the molecular and cellular features of stem cells during and following the development of the pancreas, liver, stomach, intestine, kidney, prostate, bone, and hematopoietic tissues. He described this endeavor as yielding new strategies for repairing or replacing damaged cells, tissues, and organs, and offering new insights about pathologic processes underlying abnormal development, disordered maintenance, or neoplastic transformation of these cells, tissues and organs of interest to NIDDK scientists.
He then described the new techniques, assays and tools that needed to be developed to accomplish the goals. He described the Genome Anatomy Projects' (GAPs) goal as to profile the expression of both mRNA=s and proteins in progenitor cell populations from developing and adult normal tissues. He pointed out the importance of the GAPs, and he described types of materials to be gained and the ways to distribute the information and products from the GAPs to the scientific community. In closing, Dr. Gordon announced that a draft report with recommended initiatives will be forthcoming to present to the Council.
Council member Dr. Edward Holmes asked Dr. Philip Smith to report on the Genetics, Genomics and Bioinformatics trans-NIDDK Planning Group.
Dr. Smith began the report by focusing on four areas: bioinformatics; the diabetes genome anatomy project; animal and human phenotyping; and research into complex genetic diseases such as diabetes.
He reported that there are two general categories of bioinformatics, human resources and managing data which include development of software and hardware for analysis of genomic data as well as the sharing of data from human phenotyping to gene sequence data. He pointed out that human resources were important. He said that taking advantage of software applications and hardware developments in industry that could be applicable to NIDDK research, and through partnerships to make them available to researchers was important. He stressed that it is essential to maintain a common bioinformatics platform across organ and disease systems so that these systems are able to communicate among each other. He said that standards are needed for the analysis of data and that this is being spearheaded through biotech centers. He also mentioned that some systematic annotation of gene expression, function and involvement in disease is needed.
In closing, Dr. Smith reported that prioritization within the NIDDK is needed for comprehensive genome anatomy projects as these programs are very expensive and labor intensive. He pointed out that microarray technology needs to be expanded and not limited to a few comprehensive centers. He said that the NIDDK needs to be involved in encouraging the development of new technologies and he gave several examples of such technologies.
A Council member pointed out that a challenge to the Institute will be prioritization of resources for genomics. A Council member gave several examples of new technologies that had been developed and pointed out that informatics would be needed to pull together the genotype and phenotype information. He expressed the opinion that bioinformatics expertise was lacking, and that researchers with these skills are needed. Dr. Spiegel pointed out that this community of investigators is of prime importance and they will need access to the enabling technologies to fully mine the wealth of information that will be generated. He said that he was aware of the need for bioinformatics skills both in the research communities and in the Institute.
Following the update and discussion of the two TRANS-NIDDK Planning Groups, Dr. Robert Schrier reported on the Disease Prevention and Management Working Group. He noted the alarming increase in diabetes in the U.S. between the years of 1990 and 1998 and the commensurate increase in complications as a result of diabetes. He pointed to prevention as the answer to lowering these complications. Although partnerships with private industry could yield real benefits, ethical issues and conflict of interest must be addressed. Uniform guidelines on government/private industry relationships need to be established. Recruitment of patients for clinical trials is an ongoing important issue, particularly in the recruiting of minorities. It also was noted that the design of clinical trials at an early stage in their development and the importance of focusing on the most important questions are critical elements.
Dr. Griffin Rodgers commented that several of the NIH institutes are in the process of discussing the common problems of disease prevention and recruitment for clinical trials. Although the NIDDK is eager to pursue partnerships with private industry in clinical trials, the specific roles and responsibilities of each party must be clearly documented before such issues as conflict of interest and ethical issues can be addressed.
Council members pointed out that improved animal models are needed to reduce the cost of clinical trials and to stimulate progress. Dr. Fradkin pointed out that the NIDDK DDEM proposes to fund three new animal model centers for type 1 diabetes.
A Council member argued that establishing priorities is one of the most difficult and important charges to the Institute and Council. Bioinformatics was cited as an area of particularly high importance. Dr. Spiegel called to the attention of Council to the bioinformatics and science technology initiative, begun under former NIH director Dr. Harold Varmus, that now is underway at the NIH.
A Council member pointed out that behavior and psychosocial and lifestyle factors are not being addressed in proportion to their importance and recommended that these factors be considered more fully. Dr. Spiegel noted that under the NIH Office of the Director, a new Office for Behavioral and Social Science Research (OBSSR) has been established to address environmental and lifestyle issues and that Dr. Raynard Kington, the new Director of OBBSR would address the next meeting of the NIDDK Council.
VII. SCIENTIFIC PRESENTATION: OVERVIEW OF INFLAMMATORY BOWEL DISEASE
Dr. Stephen James gave the scientific presentation, Overview of Inflammatory Bowel Disease. He said that inflammatory bowel disease usually means ulcerative colitis and Crohn's disease. He described the histology of the intestinal mucosa in ulcerative colitis and other manifestations accompanying these diseases. He characterized histological differences between ulcerative colitis and Crohn's disease, pointing out such differences as fibrosis and scarring of the bowel in Crohn's disease and that the disease may involve any part of the digestive tract from the mouth to the anus. He said the cause of these diseases was unknown, but some factors that seemed to influence them were genetic, and he gave some of the genetic linkages to chromosomes. He said there are environmental factors, including smoking, microbes and stress. Ethnic and racial differences were noted, and he said these diseases could occur at any age and may be more common than previously thought. It was further noted that these diseases are costly, involve a lot of hospitalizations, and result in a diminished quality of life.
Dr. James described and discussed the pathogenesis of these diseases, and gave a variety of theories of their causes. He described an AIDS patient who was relieved that he no longer had Crohn's disease after he developed AIDS. Dr. James attributed the improvement in Crohn's disease to the drop in CD4 T cells in the patient. He mentioned a number of therapies of varying success, and he pointed out that there are many new therapies in the pipeline. Finally, he recommended that the NIH support long term efforts to determine whether the natural history of these diseases can be changed.
Council members pointed out that environmental factors have been shown to play a part in a number of diseases within the NIDDK mission, and they recommended pursuing a national twin registry similar to the Swedish monozygotic twin registry. Dr. Fradkin pointed out that such a registry had been proposed by NIEHS to look at environmental factors that might trigger type 1 diabetes.
VIII. REPORTS FROM DIVISION DIRECTORS
A. DIVISION OF EXTRAMURAL ACTIVITIES
Dr. Hammond gave the Division report. He described the 2001 Biannual Advisory Council Report, which is a required report from the Council to the Office of the Director, NIH. He pointed out that women and minorities must be included in all biomedical projects supported by the NIH unless there is clear rationale for exclusion. He said that at all stages of review, attention to gender, race, and ethnicity must be considered for informed decisions to be made in clinical studies. Also, he reminded the Council that one of their tasks is to look at both the inclusion "process" and "outcomes." As examples of "outcomes" he gave statistics and described some of the awards made in previous years.
Dr. Hammond outlined the operating procedures for Council. He described Council members' responsibilities as the second level reviewers of the applications before them, and pointed out their three options: to concur with first level review recommendations, to recommend different budgets or length of grant period, or to defer applications for re-review. He described the process of bringing the applications to Divisional Subcouncils for discussion followed by en bloc consideration by the full Council. He also stated that the Subcouncil worksheets become part of the official record of the Council. These operating procedures were accepted and approved by the full Council unanimously.
Dr. Hammond presented a listing of Requests for Applications that will undergo Council review in May 2001. A similar listing will be provided at each Council meeting to allow the members to become familiar with the RFAs for the next cycle.
B. DIVISION OF DIABETES, ENDOCRINOLOGY AND METABOLIC DISEASES
Dr. Judith Fradkin presented the Division report in two sections: (1) the Special Type 1 Diabetes Research Funds and (2) the outcomes of a recent Diabetes Centers Directors' meeting.
First, she discussed the special Congressional appropriation of $30 million/year for 5 years for type 1 diabetes that had been given in FY 1998. She announced that it had been increased by $70 million for 3 years for a total figure of $100 million/year. There have been many discussions on how to best utilize these funds. She described some of the recommendations that had come out of these discussions, which include six broad goals: (1) to identify genetic and environmental causes of type 1 diabetes; (2) to prevent or reverse type 1 diabetes; (3) to develop cell replacement therapy; (4) to prevent or reduce hypoglycemia; (5) to prevent or reduce complications; and (6) to attract new talent to research type 1 diabetes. She said that additional researchers will be needed to utilize these additional resources. As a final point, Dr. Fradkin presented a number of possible projects that have been proposed to address this major research effort.
A Council member pointed out that a large percentage of diabetics develop hypertension leading to complications and asked whether hypertension had been considered as a priority area. He also pointed out that there is some overlap in type 1 and type 2 diabetics so that lessons learned in one could benefit the other. He pointed out that there is an epidemic of type 2 diabetes and that 35-40 percent of type 2 diabetics now are receiving insulin. It was mentioned that in the comparison between controlling hypertension and controlling blood glucose levels, UK studies have shown that there is prevention of progression of microvascular problems only if blood pressure control is effective. He pointed out that it took substantial prospective randomized studies to reach definitive outcomes in type 2 diabetes, and that current epidemiological studies in type 1 diabetes are not adequate to assess progress in treatment. He asked if the differences and the commonalities between type 1 and type 2 diabetics are being assessed. He pointed out that in type 1 diabetes, it is unknown how to treat high blood pressure effectively, and that the effects of high blood pressure on complications such as neurological, retinal, cardiovascular, and kidney need further study.
In response to the hypertension related question, Dr. Fradkin responded that the National Diabetes Educational Program advocates control of hypertension along with blood sugar and lipid controls. She said that the current clinical trials in type 2 diabetes are addressing the hypertension question and are looking at cardiovascular and microvascular outcomes. She added that perhaps a clinical trial in hypertension in type 1 diabetes also is needed.
A Council member expressed concern about the amount of funds tied to each of the aforementioned six goals. He recommended prioritization of the goals with the greatest proportion of funds targeted to the goal(s) of highest priority. He pointed out that if sufficient funds for any one of the goals are not available, then success of that goal will be jeopardized. A number of Council members supported the view that sufficient funds must be available to tackle the highest priority research questions. Dr. Fradkin pointed out that foreseeing and identifying the best chance for success is not possible and that it would be a mistake to invest heavily in one goal to the detriment of the others. Dr. Spiegel said it is a philosophical question, and the Institute has a finite budget. Since the six goals are quite different, ranging from prevention to treatment, our support of them must be balanced, and constituencies must be taken into consideration. Also, he agreed that sufficient funding for any effort is crucial. He said if the funds were distributed too broadly, and the goals were not reached, nothing would have been accomplished. Dr. Spiegel also pointed out that these additional special funds for type 1 diabetes research are for 3 years only, and that some projects such as epidemiological studies would need 10 years to show results. Therefore, the Institute must plan for funding these projects beyond the 3 years covered by the additional money.
Dr. Fradkin continued her report by updating the Council on the outcomes of the Diabetes Centers Directors' meeting. She explained that there are two types of Diabetes Centers: eight Diabetes and Endocrinology Research Centers (DERC) funded by the P30 mechanism and six Diabetes Research and Training Centers (DRTC) funded by the P60 mechanism. She then described the features of the two types of centers. She reported that the purpose of the Diabetes Centers Directors' meeting was to evaluate the goals and objectives of the centers. In addition, the participants reviewed the effectiveness of translation activities and the role of the centers in addressing the issue of health disparities as well as serving as national resources. An outcome of the meeting was agreement that the centers need more funds for equipment and personnel. It was recommended that new technology usage be increased and that there should be more interaction between industry and the centers. Dr. Fradkin reported that the Institute plans to raise the funding cap for capital equipment, to increase the budget for pilot funds, to enhance translational studies, and to create new prevention and control efforts in the centers. She said there will be expanded pilot and feasibility studies for translational studies at sites not located at the centers, but located near underserved populations.
Council members asked if the numbers of centers were to be expanded and if adequate resources would be given to them. Dr. Fradkin responded that the numbers of centers had been expanded by two at the last competition, and that allocation of adequate resources is a priority item.
C. DIVISION OF KIDNEY, UROLOGIC, AND HEMATOLOGICAL DISEASES
Dr. Briggs gave the Division report. She introduced Dr. Thomas Hostetter whom she had recruited to set up the National Kidney Disease Education Program.
Dr. Briggs began her report with an overview of the Division planning activities. She said the bladder portfolio is under review with the goal of enriching scientific research in this area. Planning meetings are being held for the development of non-invasive methods of measuring total body iron, as this is an urgent clinical problem in thalassemia patients. Furthermore, this technology has implications for sickle cell anemia patients and for long-term transfused patients. She reported that more intensive dialysis regimens such as daily dialysis or overnight dialysis might improve the outcome for patients. It was pointed out that although there is anecdotal evidence for this concept, it has not been investigated rigorously. She reported there will be a workshop on genomic tools for kidney, prostate, and the bladder. In addressing urologic issues, Dr. Briggs said there is controversy over two treatments of urinary incontinence; the short-term outcomes had been studied, but not the long-term outcomes. She reported that a randomized clinical trial comparing the two treatments will be conducted.
Dr. Robert Star reported on the progress of the biotechnology centers. He presented a brief background of the centers and pointed out that the technologies are in a truly developmental stage. He described some of the problems that have been encountered and the solutions used by the centers. As an example, he stated that when the centers found themselves to be isolated, they agreed to work together as a consortium; the grants were converted to cooperative agreements to allow greater flexibility.
Dr. Agodoa reported on the Kidney Disease and Hypertension in African-Americans clinical trial. He described the study as having begun in 1991 with a proposed project period of 7 years, and he briefly outlined the study design. Some of the results of the study are being analyzed, and proteinuria has turned out to be a major predictor of progression of kidney disease. He said the part of the study examining the effect of low mean arterial pressure versus the standard control is continuing.
A Council member asked Dr. Agodoa about the number of drugs in this study that are being used to control the high blood pressure. Dr. Agodoa replied that the average number of drugs for the patients is 2.7.
D. DIVISION OF DIGESTIVE DISEASES AND NUTRITION
Dr. Hoofnagle began the Division report by announcing the publication of a book on hepatitis C that Dr. T. Jake Liang and he had edited.
He then proceeded to present some statistics of the Division's budget figures and numbers of grants, and he described the Division's initiatives. He pointed out that the SHOW clinical trial, an initiative in nutrition, had been renamed "Look Ahead" and would begin enrolling patients this summer. Also, in the obesity program, he said it is planned to assess surgery in morbid obesity. He plans to create a new program in prevention of obesity that will also address behavioral therapy. He reported on ongoing pilot studies in prevention of obesity in high-risk populations.
He reported that as an initiative in obesity genetics, a group had been formed to hold meetings and review gene mapping. He reported a number of ongoing initiatives in liver disease, from stem cells to prospective studies of the outcomes for both the recipient and the donor of living donor liver transplantation. He reported that Council members at previous meetings had recommended initiatives in innovative technologies such as mouse models for GI physiology and the use of chip technology.
He reported other projects in the pancreas, in gastroenterology, GI stem cells, and in clinical research in hepatitis C. He then described a variety of RFAs that had been released.
Finally, Dr. Hoofnagle described a number of meetings that have been held and some planned for the future, including several consensus conferences.
A Council member pointed out that transjugular intrahepatic portosystemic shunt (TIPS) procedures are being done, and this appears to be an area that needs attention. Specifically, there is controversy over the success of the technique in comparison with other therapies. Dr. Hoofnagle responded that two clinical trials are underway on the success of TIPS in comparison with other surgical treatments.
A Council member asked about a treatment being done by a group in Barcelona to keep patients with hepato-renal syndrome alive until a donated liver could be found. Dr. Hoofnagle said that the Barcelona group is one of the best in the world and he described a clinical trial planned to address the problem.
A Council member pointed out that there were not enough livers available and asked about any studies on pancreas or islet cells from living donors. Dr. Spiegel replied that these are difficult technical problems but there are groups working on this concept.
IX. CONSIDERATION OF REVIEW OF GRANT APPLICATIONS
A total of 855 grant applications, requesting support of $123,796,549 were reviewed for consideration at the February 7-9, 2001 meeting. Funding for those 855 applications was recommended at a level of $123,796,549.
Dr. Spiegel thanked the Council members for their attendance and advice. There being no other business, Dr. Spiegel adjourned the 155th meeting of the NDDK Advisory Council on February 8, 2001, at 12 Noon.
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
Page last updated: January 11, 2011