NIH Makes Annual Appearance Before House Labor-HHS Appropriations Subcommittee

On March 16, National Institutes of Health (NIH) Director Francis Collins made his annual, and perhaps final, appearance before the House Appropriations Subcommittee on Labor, Health and Human Services, and Education (Labor-HHS) as an official of the Obama Administration. Collins was accompanied by four of the NIH’s 27 institute and center directors and/or acting directors, including Anthony Fauci, National Institute of Allergy and Infectious Diseases (NIAID); Richard Hodes, National Institute on Aging (NIA), Doug Lowy, National Cancer Institute (NCI); and Nora Volkow, National Institute on Drug Abuse (NIDA).

The NIH panel received a warm welcome from Appropriations Committee Chairman Harold Rogers (R-KY) and Ranking Member Nita Lowy (D-NY). Opening the hearing, Subcommittee Chairman Tom Cole (R-OK) was the first of the Subcommittee members to express pride in securing a $2 billion increase for NIH in FY 2016. Cole, however, expressed disappointment with the Administration’s FY 2017 budget request, which directs “$1 billion of biomedical research funds to the mandatory side of the budget.” Stating he does not plan to “let the $1 billion cut stand,” he emphasized the need to focus “on the next generation of investigators.”

Rogers echoed Cole’s disappointment regarding the President’s FY 2017 budget request, which includes $1.8 billion in mandatory funding. However, Rogers was especially pleased that Volkow was in attendance, noting that she is a “champion for advancing the science of drug abuse and addiction” as director of NIDA. He stressed his interest in the NIDA-led Adolescent Brain Cognitive Development (ABCD) Study, stating, “I believe collecting extensive data on the effects of marijuana and other drugs on a young person’s brain will help us finally appreciate the harm these substances can do over time.” The ABCD study will “help close the gap” of “sufficient scientific data about [marijuana’s] use,” said Rogers.

Appropriations Committee Ranking Member Nita Lowey (D-NY) highlighted her call last year for a bipartisan effort to double the NIH budget and noted that she was pleased with the $2 billion increase in NIH’s budget. She called on her committee colleagues to commit to doubling funding for the NIH. Pointing out that the FY 2017 budget request “would be a positive step toward that end,” she noted that while it is a net increase of $825 million, the NIH’s budget would result in a $1 billion cut in discretionary funding. She assured the NIH panel that she, Cole, DeLauro, and Rogers will not let that happen.

Labor-HHS Ranking Member Rosa DeLauro (D-CT) continued the expression of support for NIH and its budget. She thanked Cole and the members of the subcommittee for their “bipartisan work” to support NIH research. Noting the additional funds to help NIH “accelerate research to find cures for cancer, Alzheimer’s” and help the agency move forward with the Precision Medicine Initiative (PMI) and the BRAIN Initiative, DeLauro expressed disappointment to learn that HIV/AIDS research funding is not increasing in FY 2016.  The FY 2016 budget included an additional $100 million for HIV/AIDS vaccine research. DeLauro emphasized the FY 2017 budget request “is clearly constrained by sequestration and arbitrarily low budget caps.” She, too, expressed concern over mandatory funding for NIH in the FY 2017 budget request. “An increase to this health committee’s allocation is a straight forward and responsible way to support NIH research rather than to rely on mandatory funding that will not materialize,” DeLauro stressed, adding her preference for upholding “the long standing tradition of scientific independence in setting federal research agendas rather than overrid[ing] scientific judgements with Congressional preferences.” The ability to “allow this scientific independence has been a hallmark of this subcommittee,” DeLauro continued. She highlighted the bill she introduced last year which would have allowed the subcommittee to increase NIH funding by 50 percent over five years by adjusting the cap.

Collins Makes Predictions

Noting that this was his last hearing on a budget proposal by the Obama Administration, Collins indicated that he would “reflect more broadly” in his opening statement. Breaking with tradition, Collins made ten predictions in areas in which he believes there will be major progress in ten years “given a sustained commitment of resources for NIH.” These areas include basic science; the BRAIN Initiative; prevention, early identification, and mitigation of Alzheimer’s disease; effective treatment for spinal cord injuries; introduction of an artificial pancreas; organ replacement for heart failure; flu vaccines; new targets for the treatment of pain; tailored approaches to medicine; and cancer prevention strategies and therapies derived from the Vice President’s Cancer Moonshot proposal.

Responding to Cole regarding the impact on biomedical research if the subcommittee “appropriates exactly what the Administration requested” for NIH in FY 2017 (not including the proposed mandatory funds), Collins answered that “the impact would be severe” and would be “felt across every aspect of what NIH supports.” The NIH institutes and would have to “cut severely back in their programs; new initiatives would not be started.” It would “represent a very significant slowdown,” Collins continued. The FY 2016 budget for NIH provided an increase in morale for the biomedical research community, said Collins, noting that “the morale, enthusiasm, and the willingness to take risks and start new projects” is back.

Cole reassured Collins that the “committee is not going to cut $1 billion of discretionary funding from NIH,” and asked where the agency would direct additional funds if the subcommittee were able to go beyond the President’s budget request. Collins stressed that in his professional judgement there “are a lot of areas that are ripe for expansion and the opportunity to be able to go even faster on those would be welcome indeed.” Explaining that much of the research that NIH supports is generated through investigator-initiated ideas, the NIH would want to encourage “even more of those grants to be funded.”

Alzheimer’s disease

Cole asked for an update on NIH’s efforts with respect to Alzheimer’s disease and what the agency has accomplished over the last three years as a result of increased support from Congress. Hodes thanked the chair for the increase and observed that scientific opportunities surrounding the brain and Alzheimer’s disease have “expanded enormously.” With the additional funds, NIH was “poised to act on a full spectrum of well-defined priorities and milestones,” from basic biology genetics to interventions directed at people who already have the disease and “the caregivers who take so much responsibility in caring for those who have Alzheimer’s disease.”

Opioid and Heroin Addiction

Noting that 100 American lives are lost each day as a result of overdoses of prescription medicine and heroin, Rogers expressed the need for a “holistic, multipronged approach to the epidemic,” and asked how the NIH plans to address the lack of effective, non-opioid treatments for chronic pain.  Volkow explained that research on pain is studied across multiple NIH institutes along with a pain consortium that integrates these efforts. She noted that NIH is taking three approaches: (1) development of an abuse-deterrent opioid that cannot be tampered with, (2) development of potent, non-opioid analgesics, and (3) use of “simulation technologies that affect the impulses in nerves and in the brain to control and regulate pain.” Volkow also emphasized the agency’s research evaluating behavioral and cognitive interventions that can improve the outcomes in patients suffering from chronic pain.

HIV/AIDS Priorities

Rep. Andy Harris (R-MD) questioned the amount of support NIH provides towards developing a vaccine for an HIV/AIDS vaccine. Collins explained that with regard to HIV/AIDS, NIH has decided that it is time to “focus on the most important priorities to end this epidemic and a vaccine is right at the top of that list.” He noted that the agency examined its HIV/AIDS portfolio and has identified projects “which were going to come back for competing renewal,” which are no longer considered a high HIV/AIDS priority. In the next couple of weeks, Collins noted the NIH will announce that it is moving $66 million out “of areas which were good science, but they don’t seem to be high priority for HIV/AIDS, into areas that are.” A “substantial fraction” of those funds will go towards vaccine preparation. Harris responded that he would much rather see the “$100 million a year for basic behavioral and social sciences research” go into “accelerating the development of that HIV vaccine.”

National Children’s Study/ECHO

Rep. Martha Roby (R-AL) inquired about the National Children’s Study (NCS) and its follow on, the Environmental Influences on Child Health Outcomes (ECHO) program. She asked Collins to describe the results gained from the funds spent on NCS. Collins responded that the NCS, originally authorized by Congress 15 years ago, “over the course of time developed a number of features about its design that began to look as if they had not kept up with technology development and other opportunities.” The NIH concluded that it “needed a different approach,” and with the advice of experts, decided to close down the NCS and come up with an alternative strategy. The required spending report directed by Congress in the FY 2015 omnibus with regards to ECHO will be submitted a few days late, Collins reported.

Rep. Lucille Roybal-Allard (D-CA) continued the inquiry into NCS/ECHO and the accompanying timeline for putting together a ten-year plan and the establishment of an advisory panel. Collins noted that at the moment the plan is for a seven-year effort. An advisory committee is being constituted as a working group of the NIH Council of Councils, as the ECHO program involves multiple institutes.

Roybal-Allard also asked whether study’s cohorts will include “broad population samples and measures that are specifically designed to compare study cohorts to known national samples, such as the National Health and Nutrition Examination Survey (NHANES).” Collins responded that the agency had decided it would be best to hold a competition and issued a funding opportunity announcement.  NIH will know on April 15 which cohorts are interested in taking part. He added that ECHO wants to take full advantage of NHANES. He also noted the agency’s effort to set up a pediatric research network in the IDeA states, states that do not currently have a research-intensive university setting. Roybal-Allard concluded with a question regarding the status of the assessment of ECHO. Collins replied that it is dependent on the advisory group being organized, noting “FY 2017 will be the point at which there will be an assessment to see if this model is working and producing all of the data we believe it should.”

Precision Medicine Initiative

Rep. Chuck Fleischmann (R-TN) pointed out that Vanderbilt University is playing a leading role in piloting the direct volunteer portion of the PMI research cohort and asked Collins to elaborate on how that pilot program will inform the initiative going forward. Fleischmann also asked for information on the approaches NIH intended to use to recruit and retain people in PMI and if NIH is working with the National Center for Health Statistics (NCHS) or other federal partners “that fund or conduct large representative surveys to understand the biases” in PMI.

Collins responded that Vanderbilt had “just received” an award, in partnership with Google, now Verily, to set up a pilot effort to recruit direct volunteers. He acknowledged that there is a need to learn more about how to do this and noted NIH expected to learn more about what volunteers are interested in and what makes it appealing to them to join the effort, along with what they are turned off by in a few months and prior to launching the PMI. Additionally, PMI is reaching out to traditionally-underrepresented groups via community health centers and through NIH’s partners at the Health Resources and Services Administration (HRSA) to provide the opportunity for those individuals to participate. NIH is very interested in working with NCHS and NHANES, stressing that they want to ensure the “kind of data collected is going to be generalizable to the population,” said Collins.

Native Americans

Cole noted his particular interest in Native American issues and asked for an update on what NIH is doing to address Native American health. Collins noted NIH is very concerned about all populations in the U.S. American Indians, however, are a special group in terms of their history, culture, and tribal sovereignty, “which has a major effect in terms of participation in research,” he explained. The agency, via the leadership of NIH Principal Deputy Larry Tabak, has initiated a Tribal Counsel Advisory Committee designed to bring representations of the American Indian Community to NIH, Collins reported.

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Posted in Issue 6 (March 22), Update, Volume 35 (2016)

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