108th Congress

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

April 21, 2004

Witness:

• Dr. Elias Zerhouni, Director, NIH

Representative Ralph Regula (R-OH), Chairman, presided over a positive hearing that offered the opportunity for NIH to showcase the NIH Roadmap and the NIH Obesity Initiative. Virtually all Members of the Subcommittee were in attendance, including Representatives C. W. “Bill” Young (R-FL); Roger Wicker (R- MS); Randy “Duke” Cunningham (R-CA); Kay Granger (R-TX); John Peterson (R-PA); Don Sherwood (R- PA); Dave Weldon (R-FL); David Obey (D-WI), Ranking Member; Nita Lowey (D-NY); Jesse Jackson, Jr. (D- IL); and Lucille Roybal-Allard (D-CA), missing only Representatives Ernest Istook (R-OK); Mike Simpson (R-ID); Rosa DeLauro (D-CT); and Patrick Kennedy (D-RI). The majority of questions were directed to various aspects of the NIH Obesity Initiative (Regula, Wicker, Granger, Peterson, Sherwood, Lowey), and to the NIH Roadmap (virtually all Members), in terms of how it will affect the practice of medicine and their constituents. Other areas that received attention were muscular dystrophy (Cunningham and Wicker), stroke (Granger), support for stem cell research (Cunningham and Lowey), microbicide vaccine research (Lowey), and the relationship of estrogen use and development of breast cancer (Weldon). Representative Obey noted that this budget will provide the smallest percentage increase for NIH in 19 years, will not keep up with inflation, and will result in “slow motion mistakes” and “some very big missed opportunities.” Citing statistics of cancer and diabetes deaths anticipated this year coupled with new cases of multiple sclerosis and Parkinson’s disease, he opined that the Subcommittee doesn’t “have any room to respond to the possibilities raised by our past doubling of the NIH.” Mr. Obey also raised the issue of the research grants that came into question during House debate on the bill last year, and urged that the Committee not be caught unaware in this session. He urged that NIH initiate some action to “take each and every study that was mentioned last year and give us your best response as to why those were funded so that we can make an honest judgment about whether or not there was any real problem underneath the concern expressed last year.” He also urged finding a way to determine what might arise this year for similar grants.

Dr. Zerhouni’s testimony provided an overview of the proposed budget, addressed NIH accomplishments over the past year, and gave examples of how the NIH Roadmap will help shape NIH’s approach to patient- oriented research. Noting a need for a paradigm shift in medical research from treatment of established disease to detection of patients at risk prior to onset of diseases, he described specific aspects of the NIH Roadmap strategy. In particular he mentioned the development of the National Electronic Clinical Trials and Research (NECTAR) Network initiative with the potential to include community physicians trained in clinical research methodology.

Another major budget initiative is in obesity. Last year NIH created the NIH Obesity Research Task Force to coordinate NIH obesity research efforts and make recommendations for an action plan to create a budget initiative. Within the NIH budget request, which increases by 2.6 percent, NIH is increasing obesity research by 10 percent ($40 million) to $440 million. Finally, the discretionary Fiscal Year (FY) 2005 budget request for the NIH is $28,607 million ($28,527 million from this subcommittee and $80 million from the VA/HUD subcommittee), an increase of $729 million or 2.6 percent over the FY 2004 Enacted Level. The budget increases funding for the NIH Roadmap (+$107 million), and biodefense research (+$74 million), an increase of 4.5 percent over FY 2004.

Among the topics of interest was the clinical research network aimed at including community physicians. It was first raised by Representative Young but support for it was echoed by others. Dr. Zerhouni gave examples of the kind of circumstances when the network would be most beneficial, such as when there is a need to have large populations of patients participate in clinical trials. The participation rate for cancer patients, for example, is less than 4 or 5 percent, and less than 1 percent for Parkinson's disease.

Dr. Weldon raised the issue of adult stem cells and said that based on the posted proceedings of the NIH Stem Cell Task Force, the research effort seems to be directed primarily at human embryonic stem cells rather than adult stem cells. Dr. Zerhouni projected a table showing the NIH expenditures and pointed out that in FY 2003, $197 million was spent on adult stem cells and $24.8 million, or 10 percent, for embryonic stem cells, with the remaining spent on human adult stem cell applications of all kinds. The stem cell task force “is trying to stimulate the field of embryonic stem cell research, which was never funded before the President's decision,” and “it doesn't reflect a lack of interest in any way, shape or form in developed stem cells,” Dr. Zerhouni said.

Dr. Weldon also raised concerns about the data on breast cancer and estrogens. In particular, he quoted a statement from an NCI division director published in the January issue of the Journal of the NCI, who said, “It has been an uphill battle to convince the mainstream that estrogen initiates cancer.” Dr. Weldon then asked, “What did he mean by that? What is the mainstream?” Dr. Von Eschenbach responded that “there is a relationship between the development of cancers in the breast with the hormone milieu or environment in which those cells are exposed” and “estrogen seems to be at the core of a stimulation of that process. It may, by itself, not be the entire story, but in the right context it may then act as the initiator and promoter of this cancer process.” Dr. Weldon pressed the issue and said that he had heard a researcher say that “this is not a politically correct conversation to have” and wondered if the topic is being openly discussed at the NCI. Dr. Von Eschenbach said that NCI is “openly investigating.”