Testimony submitted on behalf of the American Physiological Society, Dennis Brown, PhD, Chief Science Officer.

The American Physiological Society (APS) thanks the subcommittee for its ongoing support of the National Institutes of Health (NIH). The $3 billion funding boost you provided in FY 2020, following on the increases you provided between FYs 2016 2019, have put the NIH on a path toward sustainable budget growth. These much-needed increases will help NIH address critical health problems and emerging challenges through cutting-edge research. The APS urges you to sustain this vital effort by providing the NIH budget with at least $44.7 billion in FY 2021.

Breakthroughs in basic and translational research are the foundation for new drugs and therapies that help patients, fuel our economy, and provide jobs. Federal investment in research is essential because the NIH is the primary funding source for discovery research through its competitive grants program. We look to the private sector to develop new treatments, but the private sector relies upon this federally-funded research to identify where to find the next break-through . This system of public-private partnership has been critical to U.S. leadership in the biomedical sciences. A recent article in the Proceedings of the National Academy of Sciences showed that all of the 210 new molecular entities approved by the Food and Drug Administration between 2010 and 2016 were associated with NIH-supported research. Importantly, 84 of those new drugs were first-in-class, meaning they work through a novel mechanism of action or target.

Federal research dollars also have a significant impact at the local level: Approximately 83% of the NIH budget is awarded to some 30,000 researchers who work in institutions throughout the country. They in turn use these grant funds to train students, pay research and administrative staff, purchase supplies and equipment, and cover other costs associated with their research. According to an updated 2020 report, NIH research funding in FY 2019 supported more than 475,000 jobs nationwide, generating over $81 billion in total economic activity nationwide.

The increases Congress has provided NIH over the last five years are helping to correct the devastating effects of sequestration and several years of budgets that declined in real terms due to inflation. To keep the agency on the right path forward, we urge you to continue providing meaningful and predictable annual budget increases that will keep up with the rate of inflation and take full advantage of the incredible opportunities for discovery that are before us.

As specified in the 21st Century Cures Act, NIH continues to pursue a number of important initiatives including the Cancer Moonshot, the All of Us program (formerly the precision medicine initiative), and the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. These programs focus resources on specific areas of scientific opportunity that are ripe for innovation, but it is important to bear in mind that these projects build upon decades of basic research. If we are to advance our knowledge and lay the groundwork for similar opportunities for innovation in the future, NIH must continue to invest in creative investigator-initiated research.

Over the past several decades, NIH has used a merit-based peer review system to identify and fund the best research proposals. To date, NIH has supported the work of 160 Nobel Laureates, including the 2019 winners of the Economic Sciences and Physiology or Medicine prizes. Thanks to NIH research, Americans can expect to live longer and healthier lives. NIH also plays an important role in training the next generation of scientists, supporting trainees through individual fellowships and institutional grants as they complete their graduate degrees and seek the post-doctoral training necessary to pursue successful independent research careers.

Today significant challenges loom before us: the growing threat to public health posed by the novel coronavirus outbreak requires a coordinated government response with a robust investment in research to advance understanding of the virus, the disease it causes and strategies to treat and prevent infection. NIH acted quickly when COVID-19 emerged as a problem in China and already has in place efforts to develop and test a vaccine and medications to treat the disease.

In addition to the urgent threat posed by the novel coronavirus and other new and emerging diseases, the opioid epidemic continues to represent a national public health crisis. An aging population will bring an increase in diseases that contribute to death and disability such as heart disease, diabetes, kidney disease, arthritis, and cancer. If we are to continue to advance new and innovative ways to address these and other challenges on the horizon—including developing the workforce necessary to do so—the NIH will need stable and predictable funding increases in future years.

The APS joins the Federation of American Societies for Experimental Biology (FASEB) in urging that NIH be provided with no less than $44.7 billion in FY 2021. This represents a $3 billion increase over FY 2020.

Research with Nonhuman Primates

We would also like to draw to your attention the importance of encouraging researchers to work with the most appropriate research models for the diseases they are studying. We appreciate the language you included in Division A of the Managers’ Amendment to the FY 2020 Labor-HHS-Education appropriations conference report noting the importance of research with nonhuman primates while also urging NIH to seek alternatives that can reduce and replace them. Some comments on this are in order.

Once researchers who are studying nonhuman primates have answered certain questions about a disease or biological process, they can look for alternative research models. These alternatives need to provide an accurate representation of what is being studied but require either fewer animals, a different species, or a non-animal alternative. As a matter of both law and ethics, scientists must do their best to ensure that research minimizes the pain or distress animals experience. Reducing pain and distress often also has the added benefit of reducing the numbers of animals needed to get scientifically valid results. The number of nonhuman primates needed may also decrease when parts of the question can be answered by studying a different animal species or using technologies such as computer simulations or organs-on-a-chip.

The biggest challenge in biomedical research is that there are still so many unknowns. When researchers try to understand a complex biological process or a new pathogen such as the coronavirus responsible for COVID-19, their priority is to find the best research model as quickly as possible. The optimal choice is an animal whose anatomy, physiology, immune system, etc. closely resembles that of humans. For infectious diseases, complex neurological disorders and a host of other research challenges mandated by Congress, this often means a nonhuman primate species such as macaques, squirrel monkeys or marmosets. Recognizing this, NIH has stated that more nonhuman primates will be needed in the coming years.

Nonhuman primates are expected to play an important role in finding treatments and cures for COVID-19 because of how closely their immune systems resemble that of humans. In order to develop a vaccine, scientists must first determine how the virus invades cells and then find ways to prevent that from happening. While a strain of genetically modified mice developed during the 2003 outbreak of Severe Acute Respiratory Syndrome (SARS) may be useful, before such a vaccine can be given to people, it must be tested in appropriate animal models to assess its safety and effectiveness. In addition, the only treatment we can currently offer to people who have COVID-19 is supportive care to help their bodies fight the disease. Therefore, researchers also need to find animal species that develop clinical symptoms of disease. Nonhuman primates are expected to feature prominently in this research.

The APS is a nonprofit devoted to fostering education, scientific research and dissemination of information in the physiological sciences. The Society was founded in 1887 with 28 members and now has over 8,000 members, most of whom hold doctoral degrees in physiology, medicine and/or other health professions.