House Appropriations Subcommittee Holds Oversight Hearing on Advances in Biomedical Research
On May 17, the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies (LHHS) held an oversight hearing to discuss the advances in biomedical research by the National Institutes of Health (NIH). NIH Director Francis Collins was accompanied by Institute directors Anthony Fauci (Allergy and Infectious Diseases), Gary Gibbons (Heart, Lung, and Blood), Joshua Gordon (Mental Health), Doug Lowy (Cancer), and Nora Volkow (Drug Abuse).
Welcoming the agency before the Subcommittee, Chairman Tom Cole (R-OK) noted that “investment in NIH has been the key driver in making the United States the world leader of biomedical research and has led to vast improvements in life expectancy and quality of life.” Rep. Cole expressed pride in increasing NIH’s funding by $2 billion both in FY 2017 and FY 2016. He also expressed disappointment with the Administration’s proposed cuts to NIH’s budget in FY 2018. Specifically, Rep. Cole noted he fears that the proposed cuts would “stall the progress” that Congress’ recent “investments were intended to achieve and potentially discourage promising scientists from entering or remaining in biomedical research.”
Questions from Subcommittee members covered a wide range of topics, including indirect costs, early stage investigators, the Institutional Development Award, minority health and health disparities, the opioid epidemic, the Grant Support Index (GSI), the ECHO study, international competition, public health preparedness, e-cigarettes, and the impact of the hiring freeze and a “good government shut down.”
Subcommittee Ranking Member Rosa DeLauro (D-CT) echoed Cole, noting that last year Congress “showed once again that NIH is a bipartisan priority by providing an additional $4.8 billion over ten years through the 21 Century Cures Act” (Public Law 114-255). She pointed out that the Administration’s budget would “eliminate that entire amount in just one year by cutting $8 billion from the NIH.” That size cut would “decimate NIH,” reducing its purchasing power to “a level not seen since the 1990s.” Rep. DeLauro also highlighted that the Administration’s budget would eliminate the Fogarty International Center (FIC), which “has an outsized impact on the prevention and mitigation of outbreaks abroad,” adding that FIC has actively increased the capacity of countries dealing with such diseases as Ebola, HIV/AIDS, and Zika.
Rep. DeLauro referenced the Accelerating Biomedical Research Act, a bipartisan bill that she introduced in the last Congress, which would have reversed “the devastating funding cuts to NIH in an attempt to provide stable, predictable growth.” It would set the Congress on the path to doubling the NIH’s budget as it did under the leadership of former Labor HHS Subcommittee Chair John Porter (R-IL), she explained.
Rep. Nita Lowey (D-NY), Ranking Member of the full Appropriations Committee, joined DeLauro in lamenting the $8 billion in funding cuts proposed by the Administration. She stressed that such a cut would result in 5,000 to 8,000 fewer annual research grants, be “a direct assault on university research centers by targeting so-called indirect costs,” and would eliminate FIC. In addition, Rep. Lowey noted that according to a recent study, 90,000 jobs would be lost along with more than $15 billion in economic activity. The State of New York alone would lose nearly 6,500 jobs and take a $1.3 billion economic hit, Lowey pointed out.
Collins, responding to Lowey’s question as to whether it is “even feasible for the private sector to invest enough to bridge this funding cliff,” pointed to a White House meeting two weeks prior involving CEOs from the biotech and pharmaceutical sectors who cited the NIH’s support of basic science as the reason they are able to bring discoveries to life. According to Collins, the conclusion from that group was that the NIH is “an amazing engine for discovery,” and the reduction of the inputs from industry, academia, or the agency would put the country at risk.
Grant Support Index
Reps. Chuck Fleischmann (R-TN) and Mark Pocan (D-WI) inquired about the use of the grant support index (GSI) recently announced by NIH. Rep. Pocan asked if the GSI should be implemented, what follow-up actions the agency is considering to ensure “it has the desired effect of funding and sustaining more early career investigators,” and NIH considerations regarding unintentional harms on the current scientific process. Collins explained the rationale for GSI and noted that each of the NIH institutes’ advisory councils will be discussing the issue in May and June and it will also be a topic of the Advisory Committee to the Director meeting on June 8-9.
Minority Health and Health Disparities
Rep. Barbara Lee (D-CA) inquired about NIH’s efforts in health disparities research and applied research focusing on social determinants. First, Collins highlighted the recruitment of National Institute for Minority Health and Health Disparities Director Eliseo Perez-Stable, who has been tasked with identifying ways for the agency to increase its research on these topics. Second, he asked NHBLI Director Gary Gibbons to share information about a recent study that examines the relationship between health disparities and cardiovascular disease (CVD). Gibbons noted that not all communities have benefitted from research investment in CVD and that there are a lot of disparities related to race/ethnicity. He highlighted a recent report that finds that indicators are going in the wrong direction in certain parts of the country, and that life expectancy may be shortening for some communities (such as in Appalachia, Western Virginia, Kentucky, Tennessee, Arkansas, and Oklahoma). Characterizing the recent study as a call to action, Gibbons emphasized the need to “address some of the challenges these communities are facing and a lot of those relate to both social determinants as well as adopting and getting access to health care.”
Public Health Preparedness
Rep. John Moolenaar (R-MI) asked what additional steps were needed for the United States to strengthen its level of preparedness for a possible new pandemic or emerging infectious diseases. NIAID Director Anthony Fauci responded that it is not a one-agency issue and requires cooperation and collaboration across the federal government. The mechanism used within the Department of Health and Human Services (HHS) is called PHEMCE, the Public Health Emergency Medical Countermeasures Enterprise, which involves the Biomedical Advance Research and Development Authority within NIH, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and other agencies like the Department of Defense. NIH’s role, he explained, is to understand the disease and to enhance the capabilities of people in the field to be able to address the disease.
Reps. Andy Harris (R-MD), Mike Simpson (R-ID), and Mark Pocan (D-WI) inquired about indirect costs. Rep. Pocan referenced HHS Secretary Tom Price’s testimony before the Subcommittee in April. The Secretary stated the need for “efficiencies and decreasing duplication” and noted that 30 percent of the grant money “goes for something other than the research that’s being done.” According to Rep. Pocan, the Ford Foundation recently raised their indirect costs level from 10 percent to 20 percent. Collins acknowledged the importance of the issue and explained that indirect costs are not negotiated by NIH but by HHS’ Division of Cost Assessment and are decided based upon Office of Management and Budget (OMB) guidelines. Agreements are used to cover costs such as maintaining facilities used for research, keeping the lights on, and running institutional review boards (IRBs), and are re-negotiated every four years, he explained.
Early Stage Investigators
Rep. Pocan also inquired about what NIH is doing to help early stage investigators obtain NIH funding. Collins explained that over the past several years the NIH has put in place a process that let individuals receiving their first grant application to compete against individuals who are also early stage investigators. In addition, the agency has developed a number of programs that are limited to first time investigators.
Institutional Development Award (IDeA)
NIH’s support for IDeA states was of interest to Reps. Mike Simpson (R-ID) and Steve Womack (R-AR). Womack asked what NIH was doing to ensure that funding ends up in places where there is not a high success rate in applications. Answering that the NIH is a fan of the program, Collins pointed out that the 24 states in the program are eligible for special NIH programs like the Centers of Biomedical Research Excellence (COBRE) program and the IDeA Network of Biomedical Research Excellence (INBRE) program. The agency is pleased with the many successes of these programs, and Collins added that NIH is also excited about the creation of an IDeA States Pediatric Clinical Research Network (part of the Environmental Influences on Child Health Outcomes (ECHO) program). The program provides the agency with a broader array of network participants than would otherwise be available, he explained.
Rep. Womack expressed interest in the strides made by NIDA to alleviate the effects of the opioid epidemic. NIDA Director Nora Volkow noted that NIDA is working with its sister agencies on a multi-pronged approach aimed at prevention of addiction and overdoses, along with treatment. She emphasized the need for additional interventions to prevent and revert overdoses from opioids. To contain the epidemic and prevent it from happening in the future, Volkow cited the need for alternative, effective, and safe treatment for the management of chronic pain.
Rep. Lowey asked NIDA Director Nora Volkow about the popularity of E-cigarettes and the associated health risks. Volkow acknowledged that there is limited research on E-cigarettes and expressed concern that the advances made regarding the prevention of smoking may be lost by the accessibility of these electronic cigarette devices. E-cigarettes are a gateway to cigarettes for teenagers when they use them with nicotine she informed the Subcommittee.
Noting that she has heard from industry in her district that “their talent is being recruited and their research is being outpaced in China, Singapore, Brazil, and Israel,” Rep. Katherine Clark (D-MA) asked Collins to put the competition for scientific talent in context and share his perspective of “the economic toll for the future of the United States and our innovation economy if we do not support the NIH at higher levels.” She further cited the 70-year-old Framingham Heart Study located in her district as an example of the “importance of consistency in funding.” Collins answered that the “economic case for supported biomedical research has been analyzed by many experts and is very compelling.” The NIH, itself, supports 379,000 high-quality, high-paying jobs in the U.S., but if the whole research ecosystem is considered that number is about 7 million jobs, including the biotech in the pharmaceutical industry, he explained. Other countries are seeking the return on investment that the U.S. currently enjoys, he added. He cited China’s building of universities and laboratories as an example. Talented scientists that the U.S. was once confident it could recruit are returning to China for the opportunities there.
Environmental Influences on Child Health Outcomes (ECHO)
Rep. Lucille Roybal-Allard (D-CA), an ardent supporter of the National Children’s Study, noted that Congress was “anxious to hear a progress report on the environmental influences on child health outcomes.” She also noted that she was pleased that 34 ECHO grants have been awarded to a series of existing cohort studies. She asked for a summary analysis of the characteristics of the cohorts funded and the next steps for getting the program up and running. Collins replied that NIH is very excited about the ECHO program and approximately 84 cohorts have been assembled as part of the study to learn as much as possible about environmental influences on child health. The cohorts have allowed the agency to start following 50,000 additional children. He also noted that approximately 44 states are participating in the study and the agency is examining how to make the whole greater than the sum of its parts by adding additional measures as it follows the children and their parents who were not considered as part of the original cohort study.
Rep. Jaime Herrera Beutler (R-WA) asked about the increasing trend in suicide by youth ages 10 to 24 and young adults ages 25 to 44, along with the troubling statistics that have “manifested in the increasing trends of mental illness issues, depression, and suicide ideation among students.” NIMH Director Joshua Gordon noted that this is a short-term research need and that NIMH is putting a lot of resources into the effort. He acknowledged that it was a challenging issue and that not only were the rates rising among youth but for almost every age group, class, and gender. With regard to youth suicide, Gordon explained that there are several areas of research that NIMH is confident in, but need additional research before releasing the findings. Rep. Herrera-Beutler further inquired about perinatal and postpartum depression. Gordon explained that NIMH is supporting research on both types of depression, including several grants on psychosocial interventions for post postpartum depression.
Ranking Member DeLauro wanted to know the impact of the federal workforce hiring freeze on NIH’s ability to conduct and support medical research. Acknowledging that a freeze is expected when there is a change in Administrations, Collins expressed gratitude that the patient care positions were exempted. He said NIH have been working with HHS and the agency has been given permission to proceed with other critical hires, including staffing up the All of Us Program which is expected to enroll a million Americans over the next two to three years.
Rep. Simpson asked Collins describe the impact of 2013’s 16-day government shutdown, adding that he has never “seen a good government shutdown.” Collins responded that “it was probably the darkest hour” that he has experience as NIH director. He lamented the fact that the agency had to turn patients away from the NIH Clinical Center, which is often a last resort for care.