108th Congress

Overview NIH FY 2005 Appropriations – House Appropriations Subcommittee on Labor, HHS, and Education (Representative Ralph Regula [R-OH], Chairman)

April 22, 2004

Witness:

• Dr. Elias Zerhouni, Director, NIH

Representative Ralph Regula (R-OH), Chairman, was joined by Representatives Ernest Istook (R-OK); Roger Wicker (R-MS); Anne Northup (R-KY); Dave Weldon (R-FL); Steny Hoyer, (D-MD); Nita Lowey (D- NY); Rosa DeLauro (D-CT); Jesse Jackson, Jr. (D-IL); and Lucille Roybal-Allard (D-CA). The focus of the testimony was on management, both of the NIH and the science it supports. Mr. Regula opened by noting that the days of doubling the NIH budget are over; that mission has been accomplished and the current budget provides the potential for much good research. Members tended to use this hearing to bring up issues and concerns of particular interest to them. These included topics such as whether the NIH Director has sufficient authority and funds within his immediate control to manage the enterprise (Weldon); and general conflict of interest charges raised in the press and elsewhere about NIH scientists and officials, as well as a Washington Monthly article which charged that there is a conflict of interest for scientists who publish in medical journals but have financial stakes in the products about which they are writing (Roybal- Allard). There were questions about an ovarian cancer SPORE review process (DeLauro); whether there is bias at NIH against the Atkins’ diet or against the science supported by NCCAM (Northup); the need for the Federal Government to recover costs from sales of drugs such as taxol (DeLauro); cancer survivorship and lack of good chronic pain management (Wicker); and whether NIH Institutes and Centers (ICs) are still supporting minority health research or whether their support has declined since the creation of NCHMD (Jackson). Representative Jackson requested a complete project list of minority health research and description for FYs 2003, 2004, and 2005 for the record.

As the focus of this hearing was on management, Dr. Zerhouni highlighted changes initiated over the past year focused on three areas: 1) managing corporate responsibilities by streamlining and rationalizing decision-making processes, 2) transforming business practices, and 3) managing the science within NIH’s Institutes and Centers. Drs. Spiegel and Landis represented the ICs and described how they manage the science within their respective Institutes. Dr. Zerhouni described the newly created Steering Committee and its working groups whose goals are to improve NIH’s corporate decision-making, and streamline and simplify management processes. Last year, Dr. Zerhouni also created an Administrative Restructuring Advisory Committee (ARAC) to review and make recommendations regarding several NIH administrative functions, including Acquisition, Finance, Budget, Grants Management, Facilities, Equal Employment Opportunity, Information Technology (IT) and Human Resources. To address the concerns regarding conflicts of interest among NIH’s researchers and Institute Directors, a Blue Ribbon Panel was constituted as a working group of NIH’s Advisory Committee to the Director (ACD). The Panel is to review and shortly make recommendations for improving the existing financial conflict of interest rules and procedures under which NIH currently operates. He also mentioned the Mark O. Hatfield Clinical Research Center (CRC), which will open in December of this year. The CRC will combine state-of-the-art laboratories with patient care and procedure areas in one tightly integrated facility, and will be the largest hospital in the world totally dedicated to clinical research.

Dr. Spiegel addressed his approach to managing the science programs of NIDDK. He noted that because innovative scientific research, by definition, addresses the unknown, we cannot predict where, how, or when the next major advances will occur, so “all parts of the research pipeline must be primed.” Therefore, the NIH funds studies across the continuum of basic, translational and clinical research, and uses multiple mechanisms. “We engage our many stakeholders and our National Advisory Council in strategic planning at multiple levels.” He then described how he applies scientific judgment to portfolio management for two of their diseases: Crohn’s disease and polycystic kidney disease (PKD). The ultimate goal for PKD research is to develop effective treatments, and for this reason, NIDDK launched the Consortium for Radiologic Imaging Studies of PKD and established the PKD Clinical Trials Network to assess the best strategies for slowing progressive loss of kidney function in PKD.

Dr. Landis, in addressing the management at NINDS, also mentioned the NIH peer review system, which ensures the significance and scientific quality of research projects, and described the guidance NINDS receives on several levels about how best to allocate its resources among the many, competing priorities. Using Parkinson's disease to illustrate the comprehensive and inclusive planning and management efforts that guide NIH disease research, she mentioned first the NIH PD Research Agenda, a comprehensive description of the research needed to understand the genetic and environmental factors that cause PD. More recently, the NIH Director convened a "Summit" with a small group of outstanding scientists to gain a better sense of where the field of PD research stood at the global level, and to identify "roadblocks" that might be impeding progress. The NIH developed the recommendations from the Summit into a matrix of short-to-long range, and low-to-high risk goals that address these roadblocks. This Matrix is a management tool that will evolve in response to scientific progress.

The latter presentation generated discussion by Representative Wicker about Parkinson’s disease and the extent to which the NINDS has not “fully” implemented the original PD Research Agenda. Dr. Landis responded that the Institute is committed to this research and within the budget is addressing the most promising scientific opportunities.