The 21st Century Cures Act, also known as the Cures Act, provides the National Institutes of Health (NIH) with critical tools and resources to advance biomedical research across the spectrum, from foundational basic research studies to advanced clinical trials of promising new therapies. Both the U.S. House of Representatives and the Senate passed it with strong bipartisan support, and it became law on December 13, 2016.
Explore This IssueAugust 2017
The legislation provides $4.8 billion in funding to four highly innovative scientific initiatives over the next 10 years, including the All of Us Research Program, formerly known as the PMI Cohort Program ($1.45 billion), the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative ($1.5 billion), Cancer Moonshot ($1.8 billion), and the Regenerative Medicine Innovation Project ($30 million) (See Table 1).
“Funding to the NIH has been one of the most critical drivers of improved health in the world,” said Joseph E. Kerschner, MD, professor of otolaryngology, microbiology, and immunology, dean of the School of Medicine, and executive vice president of the Medical College of Wisconsin in Milwaukee. “Virtually every disorder that an otolaryngologist comes into contact with has been altered, with improved patient outcomes, because of NIH-funded research. Specifically, the Cures Act includes increased funding to the NIH for cancer research—including cancer of the head and neck—which has the tremendous potential to make significant progress toward improved care and survival rates. Other areas of emphasis include funding for research in opioid use, behavioral health, and access to healthcare, which are critical areas impacting otolaryngologists and their patients.”
Baldwin Wong, chief of the Science Policy and Planning Branch of the National Institute on Deafness and Other Communication Disorders (NIDCD) in Bethesda, Md., believes the act supports the NIDCD’s mission and will benefit the field of otolaryngology in many ways. The NIDCD is one of 27 NIH institutes and centers within the U.S. Department of Health and Human Services.
Here’s a closer look at each of the four initiatives.
Funding to the NIH has been one of the most critical drivers of improved health in the world. Virtually every disorder that an otolaryngologist comes into contact with has been altered, with improved patient outcomes because of NIH-funded research. —Joseph E. Kerschner, MD
All of Us Research Program
For this program, NIH will recruit one million or more adult volunteers in the United States to participate in a study to accelerate research for a wide range of diseases and improve the understanding of health. “Participants will provide information about their medical history and lifestyles on a questionnaire and may also be asked to provide physical measurements or donate a blood or urine sample,” Wong said. “Individuals with communication disorders could be part of this volunteer group, as the study aims to reach a cross-section of the country.”
A database will house and provide secure access to the data. Private and public partnerships will be established among scientists and physicians to share the data and study genetic factors, environmental exposures, and lifestyles and their impact on diseases and disorders. “Otolaryngologists partnering in the study will have access to this data and might be able to identify susceptibility genes or environmental factors that contribute to sensorineural and hereditary hearing loss,” Wong said.
This facet of the Cures Act is aimed at revolutionizing our understanding of the human brain. Researchers intend to use new imaging tools to produce a revolutionary, dynamic picture of the brain that shows how individual cells and complex neural circuits interact in real time. “Researchers will be able to see which areas of the brain are involved in normal or disease processes,” Wong said. “Being able to visualize the affected areas of the brain in an individual with tinnitus using functional magnetic resonance imaging or having the ability to image auditory processing disorders or hyperacusis in the brain in real time would have great benefits.”
This imaging data could fill significant gaps in current knowledge and provide unprecedented opportunities for exploring how the brain enables the human body to record, process, utilize, store, and retrieve vast quantities of information, all at the speed of thought. Ultimately, researchers hope they will be better equipped to treat, cure, and even prevent brain disorders.
The Cancer Moonshot aims to accelerate cancer research to make more therapies available to more patients, while also improving the ability to prevent cancer and detect it early. Presently, the National Cancer Institute is asking scientists to submit grant applications for cancer research. “Scientists interested in studying head and neck cancers may submit applications for support as part of this initiative,” Wong said.
Regenerative Medicine Innovation Project
Regenerative medicine is an emerging area of science that holds great promise for treating and possibly curing a variety of conditions. The initiative promotes the use of adult stem cells and other technologies—such as engineered biomaterials and gene editing—to repair or replace damaged cells, tissues, or organs.
“If scientists could coax adult stem cells to regenerate new cells to replace lost or damaged hair cells in the inner ear after hearing loss, there may be a good chance that hearing could be restored,” Wong said. “Or, if researchers could repair damaged vocal folds, that may help alleviate some voice disorders.”
Wong is optimistic about the benefits that the Cures Act’s initiatives will bring. “Although a specific study may not find a cure, it could uncover new knowledge about normal and disease processes that could lead to a cure,” he said. “Or, it could provide the necessary basic research that eventually leads to a new treatment, such as a new assistive device or a new drug.”
Karen Appold is a freelance medical writer based in New Jersey.