The National Institute of Diabetes & Digestive & Kidney Diseases

February 1996 - Meeting Minutes

Department of Health and Human Services
Public Health Service
National Diabetes and Digestive and Kidney Diseases
Advisory Council
February 8, 1996

I. Call to Order

Dr. Gorden called to order the 140th National Diabetes and Digestive and Kidney Diseases Advisory Council meeting on February 8, 1996, at 8:05 a.m.

A. Attendance

Council Members Present (See Attachment A)

Dr. Irwin M. Arias
Dr. Dennis A. Ausiello
Dr. Richard J. Boxer
Dr. Pamela B. Davis
Dr. Jack E. Dixon
Dr. James R. Gavin, III
Dr. Daryl K. Granner
Dr. Yuet W. Kan
Dr. Saulo Klahr
Dr. Donald W. Powell
Dr. Barbara Rolls
Mrs. Suzanne Rosenthal
Ms. Patricia Grace Smith
Dr. Joseph T. Spence (Ex Officio)
Dr. Joseph H. Szurszewski
Dr. Richard D. Williams
Dr. Roy K. H. Wong (Ex Officio)

Council Members Absent

Ms. Sharon A. Alleyne
Mr. Ramon M. Gonzales
Mr. Robert W. Johnson, IV

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) and Division of Research Grants (DRG), and other NIH staff members. Guests were present during the open parts of the meeting. Attendees included the following:

Syed Amir, DRG David Badman, NIDDK R. Bain, NIDDK Donna Belcher, NIDDK Sharon Bourque, NIDDK Francisco Calvo, NIDDK Paul Coates, NIDDK Florence Cohen, NIDDK Catherine Cowie, NIDDK Nancy B. Cummings, NIDDK Charlenia Daniels, NIDDK Cerise Day, NIDDK Jane DeMouy, NIDDK Nancy Dixon, NIDDK Jackie Dobson, NIDDK Richard Eastman, NIDDK Linda Edgeman, NIDDK Gayla Elder-Leak, NIDDK Dave Ellis, NIDDK Bill Elzinga, NIDDK J. Everhart, NIDDK Ned Feder, NIDDK Bill Foster, NIDDK Judith Fradkin, NIDDK Usha Ganti, NIDDK John Garthune, NIDDK Phillip Gorden, NIDDK Roberta Haber, NIDDK Ann Hagan, NIDDK Frank Hamilton, NIDDK Robert D. Hammond, NIDDK Joan Harmon, NIDDK Mary Harris, NIDDK Barbara Harrison, NIDDK Shirley Hilden, DRG Trude Hilliard, NIDDK Jay Hoofnagle, NIDDK Van S. Hubbard, NIDDK Desiree Johnson, NIDDK Camille Jones, NIDDK

Thelma Jones, NIDDK Mushtaq A. Khan, DRG Sooja Kim, DRG Mike Knecht, DRG Tom Kresina, NIDDK Krish Krishnan, DRG John Kusek, NIDDK Kim Law, NIDDK Alec S. Liacouras, DRG Helen Ling, NIDDK L. Earl Laurence, NIDDK Billie Mackey, NIDDK Lorraine Marchand, NIDDK Donita Marconi, NIDDK Ron Margolis, NIDDK Winnie Martinez, NIDDK Dan E. Matsumoto, NIDDK Ken May, NIDDK Catherine McKeon, NIDDK Clifford Moss, NIDDK Diana Nguyen, NIDDK Denise Payne, NIDDK Aretina Perry, NIDDK Judith Podskalny, NIDDK Rose Pruitt, NIDDK Sharon Ricks, NIDDK Charles Rodgers, NIDDK Lakshmanan Sankaran, NIDDK M. James Scherbenske, NIDDK E. Singer, NIDDK Philip F. Smith, NIDDK Walter Stolz, NIDDK Gary Striker, NIDDK Tommie S. Tralka, NIDDK Carmelle Veasley, NIDDK Charles A. Wells, NIDDK Alice Wofford, NIDDK Susan Yanovski, NIDDK Rita Yeager, NIDDK Charles Zellers, NIDDK.

C. Conflict of Interest Statement

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 Thursday, February 8, 1996, from 8:05 a.m. to 10:00 a.m. and closed from 10:00 a.m. to 5:00 p.m. for review, Discussion, and evaluation of grant applications.

II. Consideration of the Summary Minutes of the Previous Meeting

Dr. Gorden asked for acceptance of the NDDK Advisory Council Summary Minutes of the last Council meeting. The minutes were accepted unanimously.

III. Future Meeting Dates

Dr. Gorden asked for consideration of meeting dates for future NDDK Advisory Council meetings, and the following meeting dates were proposed and accepted:

• May 29-30, 1996
• September 18-19, 1996
• February 12-13, 1997
• May 28-29, 1997
• September 17-18, 1997
  

IV. Director's Report

Dr. Gorden began his report by introducing new Council member Dr. Richard Boxer and welcomed him to the Council. He also thanked previous Council members, Dr. Pamela Davis and Ms. Patricia Grace Smith, who had graciously agreed to attend this Council meeting. Dr. Gorden continued his report by acknowledging the efforts of the NIDDK staff during the three weeks of Government shutdown and the week of closing due to the heavy snowfall.

He reported on the continuing resolution that had given the NIH funds to operate through the 1996 fiscal year.

Dr. Gorden continued his report by announcing new NIH appointees and introducing new NIDDK staff members. He announced the appointment of Dr. Bernadette Marriott to head the Dietary Supplement Health and Education Act Office and Dr. Story Landis to head the Division of Intramural Research of the National Institute of Neurological Disorders and Stroke. Dr. Gorden introduced two new NIDDK staff members: Dr. Catherine Cowie, Director of the Insulin-Dependent Diabetes Mellitus Clinical Trials Program in the Division of Diabetes, Endocrinology, and Metabolic Diseases, and Dr. Jean Pennington, Research Nutritionist with the Division of Nutrition Research Coordination.

Budget

Mr. L. Earl Laurence gave the report on the Budget. He said it was a very pleasant surprise to learn that the NIH would receive a 5.8 percent increase under the continuing resolution that was passed. The NIDDK's share of that increase constitutes a 4.4 percent increase over its FY 1995 Budget. Mr. Laurence then went over tables to compare expenditures for the two fiscal years. He pointed out that the payline for FY 1995 was at the 21st percentile for competing continuation awards and the 19 percentile for new awards. He said that there would be a large drop in the number of competing awards that could be made in FY 1996, and that this had led to an initial concern that there would be a severe drop in the payline for FY 1996.

Mr. Laurence then explained how year-to-year instability occurs in the number of competing awards that can be made, even though there is relative stability in the total number (competing and non-competing) of grants. He pointed out, for example, that in years when appropriated funds were sufficient to award only a relatively small number of competing grants, this would mean that the non-competing commitments for the next few years would be less than expected. Then, in the next year, relatively more competing awards could be made, leading to a marked increase in non-competing commitments for the years after that, and so on. Mr. Laurence predicted that the payline for FY 1996 would be approximately the same as it had been in FY 1995. He said that this was at least partially due to the NIH receiving fewer applications than expected for potential funding in FY 1996.

Discussion

A Council member remarked that the competing grant number was of prime concern and that cutting the number of competing grants by 20 percent was the wrong message to send to the grantees. He suggested that a better way of managing the funds available would be to withhold the four percent yearly increase to non-competing grants and use those funds for additional competing awards.

Mr. Laurence responded that increasing the number of competing awards in a year when the Budget was generous would increase the non-competing pool of grants for several years after that. He said that if the Budget for FY 1997 were not as generous as the 5.8 percent increase that was received this year, and if the number of competing grants were substantially increased in FY 1996, then the funds commited to the non-competing commitments in 1997 would require a relatively large proportion of the FY 1997 Budget, resulting in lowering the numbers of competing awards that could be funded in FY 1997. He also pointed out that the NIH Cost Management Plan required all Institutes to provide the four percent increase each year to non-competing awards and that, while it was possible to change the four percent to some other number, the decision to do so would be an NIH-wide one and not one that could be made by NIDDK alone.

A Council member asked whether these cycles of competing and non-competing grants being out of proportion would be recurring each year. Mr. Laurence responded that several efforts were being made to try to control this cycling, including finding ways to expend funds in good years that would not incur commitments for future years.

A Council member pointed out that the decrease in applications received was a direct result of the projected low paylines. He said that one can always say that it may be worse next year, but by decreasing the numbers of grants by 20 percent the message is sent that the NIH is downsizing and shutting down.

Mr. Laurence responded that the NIDDK would like to see stability in grant numbers, and not 600 competing grants one year and 450 the next. He pointed out that the total number of grants in the NIDDK portfolio had remained approximately the same over the past 10 years.

A Council member pointed out that there was great concern in the applicant community that the competing grant numbers were going down and that this would have a serious negative impact. He said that some innovation and new ideas were needed to fund as many competing awards as possible each year. Mr. Laurence responded that he needed Council members' ideas on how this year's Budget could best be used. He said that the NIH and the NIDDK were pleased with the Budget received from the Congress this year, and he pointed out that the Budget for next year was unknown. He said that providing stability was important and that the objective was to determine the best way to dampen down the highs and lows of the competing numbers of grants.

A Council member asked to see a projected Budget that reflected the plan to fund more competing applications. Mr. Laurence responded that the Budget information was so recent that the options had not been reviewed. He said in response to a Council member's request that at the next Council more information would be available.

Council members asked for more data on the competing and non-competing grants and for simulation models that would help to predict the effects of various possible policies and strategies to help stabilize the grants. Council members said that such policies and strategies might include limiting grant years, the numbers of grants that a principal investigator might hold, the dollar amount of grants, and reducing the four percent yearly increase to two percent. Council members offered other suggestions for stabilization and indicated that the scientific communities were concerned about the level of the payline and the possibility that giving multiple grants to established investigators might result in the loss of some new investigators from the system.

Dr. Gorden thanked the Council members for their efforts in helping to achieve the Budget for the NIH and the NIDDK that would enable the NIDDK to meet its commitments to the research community. He pointed out that the bipartisan support of the Congress meant that the NIH Budget was not caught in the battle going on in the Congress as were some of the other Government agencies.

VI. Report on the Director's Advisory Meeting

Dr. Don Powell reported on the NIH Director's Advisory Committee Meeting, which he had attended as the NIDDK representative. He described the reports of two ad hoc committees that had been convened to (1) review the NIH investment in research on gene therapy and (2) review the Recombinant DNA Committee's requirements for review of protocols involving recombinant DNA.

He said that the first committee had identified two major issues regarding expenditures on gene therapy. The first was that gene therapy had not been as successful as hoped as soon as hoped, and that an unrealistic public expectation had developed of the benefits of gene therapy. He pointed out that this was a problem to the extent that some patients were foregoing therapies that had been proven to be effective so that they could receive treatments involving gene therapy that were unproven at best. He described the other issue as recommending that a higher proportion of gene therapy expenditures be allocated to developing the basic science knowledge required for gene therapy to be successful.

The second committee was given the charge to review the Recombinant DNA Committee's procedure for reviewing research protocols. Some scientists, particularly in the gene therapy community, had complained about both the review requirements of the Recombinant DNA Committee and the FDA review requirements, pointing out that protocols were required to be reviewed twice. It was pointed out that the protocols were being reviewed to safeguard the public, since these experiments involved genetically-altered organisms.

Dr. Powell described another group that had been charged to review the economic benefits of biomedical research and to report on their findings in 1997. He pointed out that the group appeared to be dominated by economists, and he expressed misgivings that without additional medical and basic science expertise in the group, the group might not be able to develop a clear straight-forward description of the benefits of research, economic and otherwise, that would be understandable to the legislators.

Discussion

Council members expressed concern that the group was trying to describe the benefits of biomedical research without sufficient medical input, and they pointed out that an example of the problem was the over-selling of gene therapy as a treatment method that would be both highly effective and inexpensive as well. They described the group as trying to articulate and participate in translating how biomedical research had been beneficial, but they emphasized that it was difficult in any case to show specific linkages between basic research and clinical developments.

Council members were concerned about how the report would be developed and where it would go, and they pointed out that if it did not show the benefits of biomedical research in a decisive way, it would be harder to dispell the negative publicity with a second or third report.

This concluded the Open portion of the meeting.

VII. Consideration of Review of Grant Applications

* Includes both DK primary and secondary
Of these applications, 3 were received from institutions outside the U.S.A.

Summary Table 2

Council did not concur with Initial Review Group recommendations on 6 applications.

VIII. Adjournment

Dr. Gorden thanked the Council members for their attendance and advice. There being no other business, Dr. Gorden adjourned the 140th meeting of the NDDK Advisory Council on February 8, 1996, at 3:00 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