Controversy surrounds the proposed Advanced Research Projects Agency for Health (ARPA-H)

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By Bill Reddy, LAc, DiplAc

A newly proposed agency to advance biomedical and health sciences is triggering serious backlash from United States legislators and the research community regarding its structure and function. The U.S. Congress introduced H.R. 5585 on October 15, 2021, entitled the “Advanced Research Projects Agency for Health (ARPA-H) Act,” and with it, there have been many questions.

Inquiries have included what the new agency should focus on, whether it should be placed under the Department of Health and Human Services (HHS) or the National Institutes of Health (NIH), what would be an appropriate funding level, and how it would be evaluated. The 23-page bill lists the goals of the organization as follows:

• Foster the development of new, breakthrough capabilities, technologies, systems, and platforms to accelerate innovations in health and medicine;
• Revolutionize diagnosis, mitigation, prevention and treatment of diseases through the development of transformative health technologies and high need cures;
• Promote high-risk, high-reward innovation to develop high need cures, and ensure the U.S. maintain global leadership in science and innovation; and the highest quality of life and health for its citizens.

Obviously, the above goals fall under the NIH mission, and critics are questioning whether a “standalone” agency is necessary. According to the Subcommittee on Health of the Committee on Energy and Commerce hearing on February 8 entitled “ARPA-H: The Next Frontier of Biomedical Research, both  President Joe Biden and former NIH Director, Francis Collins, MD, PhD, want ARPA-H to be placed within the NIH, but a number of legislators and researchers are recommending it operate autonomously under HHS. Some argue that since NIH has a firm foothold in our nation’s medical research and has the funding mechanisms and administrative infrastructure to host ARPA-H, it would make the most sense to place it within NIH. However, legislators and others suggest that NIH has a bureaucratic grant structure and layers of review committees in place to choose the most valuable (and least risky) research projects. The rest suggest that Congress just press NIH to accept bigger risks in its research.

The original purpose of the Defense Advanced Projects Research Agency (DARPA), founded in 1958, was to take untested, out-of-the-box ideas and apply them to produce innovative technologies within a tight timeframe. According to the Advanced Research Project Agency for Health (ARPA-H) Concept Paper, Biden would like to take this model and apply it to finding cures for cancer, wearable devices for real-time health monitoring, cognitive computing technologies, and 3D printing of living human tissues and organs. Proponents believe that having a “flat” organizational structure and independence to make decisions regarding funding and research priorities will make it flexible and able to meet ambitious goals, if situated within HHS. They believe that working closely with private industry, ARPA-H could catalyze fast-tracking some promising technologies and techniques to the next level to detect, diagnose, treat, and cure disease.

One thing that is blatantly missing from current NIH research is the actual study of health. What habits, environment, attitudes, and lifestyle promote health and well-being? What do 10,000 healthy octogenarians have in common? The NIH does a splendid job at investigating the etiology and pathogenesis of disease on a molecular level, performing randomized control trials of drugs, surgery, and other conventional interventions, as well as researching basic science, but misses the mark on integrative approaches and holistic thinking. If our future endeavors are to focus on health promotion, wellbeing and quality of life, it is imperative that research be undertaken to explore the value of holistic integrative healthcare and practices/or approaches that compare and evaluate different models of care. ARPA-H has a huge potential to fill that role, however, it is not reflected in H.R. 5585 or the 21^st Century Cures Act signed into law in late 2016. The current fiscal year funding for ARPA-H has been identified at $6.5 billion, however, the agency does not have any clear marching orders, and the director and deputy director have yet to be identified.

In the February 8 Subcommittee on Health of the Committee on Energy and Commerce hearing, expert witnesses and stakeholders testified on how and where the new agency should be established. Keith Yamamoto, PhD, director of University of California San Francisco’s department of Precision Medicine said, “Congress would be wise to recognize that ARPA-H’s success will depend upon its creation of a structure, culture, operating model, and practices that differ dramatically from NIH, enabling it to take and overcome risks, to achieve breakthrough applications, rather than discovery, over knowledge.” He went on to state that “ARPA-H should be authorized as a free-standing agency within HHS, rather than as a component of NIH.”

Esther Krofah, executive director of FasterCures and the Center for Public Health at the Milken Institute, testified that ARPA-H can operate similarly to ARPA-E which operates within the Department of Energy, while still fostering a different culture and autonomy. She feels that leadership, funding, and priorities take precedence over location.

Admiral Brett Giroir, MD, who held executive-level positions at both DARPA and HHS said that any attempt to house an ARPA-H like program within NIH would be a “fatal mistake.”

Eric Lander, director of the White House Office of Science and Technology Policy wrote that “ARPA-H’s organization should be flat, lean, and nimble. The culture should value bold goals with big potential impact over incremental progress. The organization should lure a diverse cohort of extraordinary program managers from industry or leading universities, for limited terms, with the chance to make a huge impact. They should be empowered to take risks, assemble portfolios of projects, make connections across organizations, help clear roadblocks, establish aggressive milestones, monitor progress closely, and take responsibility for the project’s progress and outcomes.”

Lander, in his opening testimony during that hearing concluded by saying, “In summary, I believe that ARPA-H has the potential to revolutionize how we prevent, treat, and cure a range of diseases that impact Americans’ health and quality of life. The DARPA model is not the right approach for all challenges, but it’s a powerful approach for driving certain kinds of innovation — including the kind of innovation we need for health, transforming the seemingly impossible into reality.”

Margaret Erickson, PhD, RN, CNS, APRN, APHN-BC, SGAHN, chair of the Integrative Health Policy Consortium (IHPC) said during a follow-up phone call related to ARPA-H, “As we move from a biomedical paradigm of illness and disease focused care to one of health promotion, wellness, and wellbeing it is time to embrace a person-centered, holistic, integrative approach that focuses on primary not tertiary care. It is time that holistic, integrative healthcare is valued, recognized, and utilized to promote quality of life and wellbeing, not just an adjunct to tertiary care. The first step we need to take is to evaluate different models of care to support professions and practices that put the body-mind-spirit in an optimal place to heal and thrive.”

The jury is still out on the proper structure and placement of ARPA-H, but the intent is on point. The Biden administration is considering creating an ARPA-C (for climate) in the near future to develop “game-changing” energy and climate solutions that will also have direct impact on public health.

References: 

1. E. Lander; ARPA-H: Accelerating biomedical breakthroughs, Science Magazine 6/22/21. Retrieved from: https://www.whitehouse.gov/ostp/news-updates/2021/06/22/science-magazine-arpa-h-accelerating-biomedical-breakthroughs/  3/2/22.
2. E. Lander; Witness Testimony, ARPA-H: Hearing on The Next Frontier of Biomedical Research; Retrieved from: https://sociable.co/wp-content/uploads/2022/02/Witness-Testimony_Lander_HE_2022.02.08_0.pdf. 3/2/22.