The U.S. leads the world in biomedical research. The country’s premier research agencies are the National Institutes of Health, which focuses on biological research, and the National Science Foundation, which focuses on breakthroughs in basic sciences. A continued national commitment to investing in these areas is essential if the U.S. is to remain at the forefront of medical breakthroughs.
In order to accomplish the nation’s research agenda, clinical trials sometimes require the participation of human subjects who require specific protections.
In addition to research involving human subjects, other promising fields of study involve stem-cell research and genetic research. Like research using human subjects, these approaches raise ethical considerations and are often the subject of controversy.
The National Institute of Health’s research agenda is broad, focusing on the prevention and treatment of common diseases such as cancer. At the same time, it also studies the effectiveness of complementary and integrative medicine such as acupuncture and mindfulness-based stress reduction.
Cannabis, also generally referred to as Marijuana, is the name given to the dried buds and leaves of varieties of the Cannabis sativa plant. Scientists have identified many biologically active components in cannabis. These are called cannabinoids. The two most studied components are the chemicals known as THC and CBD.
As of 2019 more than 30 U.S. states and territories have legalized the medical use of cannabis. State laws vary in a number of ways including for what conditions medical use of cannabis is allowed, the amount of cannabis that can be possessed, how where and by whom it is allowed to be grown or sold, and other factors.
At the federal level, the US Drug Enforcement Administration (DEA) lists cannabis and its cannabinoids as Schedule I controlled substances. This means that they cannot legally be prescribed, possessed, or sold under federal law. Nonetheless, the Department of Justice has instructed federal prosecutors not to engage in enforcement of federal marijuana or cannabis laws against companies and individuals who were acting in accordance with state law. Although this was briefly rescinded in January 2018 by then Attorney General Jeff Sessions, Attorney General William Barr affirmed at his confirmation hearing that the DOJ would once again not engage in enforcement of federal cannabis laws for complying with state law.
In addition, as of 2019, the U.S. Food and Drug Administration (FDA) has approved one cannabis-derived drug (Epidiolex), which contains CBD, a chemical component of the cannabis plant. The drug is prescribed for treatment of seizures associated with epilepsy.
The National Academy of Sciences, Engineering and Medicine issued a comprehensive report in 2017, which reviewed the overall scientific literature that supports therapeutic and other health effects of cannabis or cannabinoids. The report concluded that there are several clinical problems for which there is conclusive or substantial evidence that cannabis or cannabinoids are effective—pain, chemotherapy-induced nausea and vomiting, and patient reported multiple sclerosis spasticity symptoms. The report also concluded there is moderate evidence that cannabis or cannabinoids are effective for improving short-term sleep outcomes individuals with sleep disturbances associated with a variety of conditions. The report also concluded there is limited or insufficient evidence for that cannabis is effective treatment for several other medical conditions and there is a need for further research on the health effects of cannabis. The report also notes that the classification by the DEA of cannabis as a Schedule I substance impedes the advancement of this research.
Reducing disparities: It is widely recognized that disparities in service delivery occur by race, ethnicity, age, sex, sexual orientation, and disability status. Experts agree it is essential that service-delivery systems, regardless of model, consider the specific needs of the populations being served. In particular, it is important that systems and providers have the ability to identify and measure disparities so that gaps in care can be identified and addressed. Therefore, collecting and reporting performance information that is stratified to determine the existence of disparities is essential. In addition, service delivery must be culturally competent. It must honor individuals’ preferences, values, and circumstances. Effective approaches to culturally competent care include the use of community health workers, translation/interpreter services, and practices to ensure a culturally competent workforce. In addition, culturally competent health promotion and education can help members of historically disadvantaged groups understand the value of emerging service-delivery models.
Eliminating racial and ethnic health disparities and addressing all the social determinants of health are among the nation’s top priorities. So much so that the Affordable Care Act requires all federally conducted or federally supported health programs, activities, or surveys to collect data on race, ethnicity, and primary language, among other things. The Department of Health and Human Services is tasked with devising methods for reporting such data. These data will help the U.S. develop a targeted research agenda designed to reduce health disparities.
Geroscience is the study of the aging process and how it affects the disease process and susceptibility to disease—and vice versa. More specifically, according to the National Institute on Aging, geroscience seeks to study the “genetic, molecular, and cellular mechanisms that make aging a major risk factor and driver of common chronic conditions and diseases of older people.”
This exciting and growing field targeting fundamental aging processes might delay, prevent, alleviate, or reverse a wide range of diseases and conditions associated with aging. A National Institute on Aging website notes that “while aging itself isn't a disease, the aging process represents a major risk factor for several chronic diseases and conditions, including frailty and lack of resilience.” Some researchers focused on the geroscience (aging process) contend that investment and grants focus too much on prevention of and treatment for specific diseases, rather than on the study of these fundamental elements of the aging process itself and this area merits more investment and attention. Nonetheless, clinical trials of interventions designed to slow the biological aging process—and delay or prevent associated disease—are already underway. Many experts do not expect to see initial evidence of positive results for at least 2-3 years and maybe as long as ten or more years for meaningful results , but this area of research if successful has the potential to provide more years of good health as people continue to live longer lives.
MEDICAL RESEARCH: Policy
MEDICAL RESEARCH: Policy
Policymakers should provide greater investment in research on the aging process, particularly on diseases associated with aging or diseases that disproportionately affect older people. These should include diseases such as dementia (including Alzheimer’s disease), Parkinson’s disease, communicable diseases (e.g., COVID-19), and chronic conditions that affect both younger and older Americans, as well as complementary and integrative medicine.
Adequate funding should be provided for the nation’s leading health-research agencies to carry out a comprehensive health-research agenda designed to promote health and wellness in every setting and across settings.
Funding for specific diseases should be allocated to the National Institutes of Health fairly and equitably. They should also receive adequate support for basic science, stem-cell research, and genetic research to advance knowledge about preventing and treating serious diseases and conditions that affect people of all ages, as well as ensure that the U.S. remains at the forefront of biomedical research and development.
Allocation of funds
Policymakers should ensure equitable allocation of funding for research addressing the health concerns of older adults, women, and members of historically disadvantaged groups. The research should also address racial and ethnic disparities in health care, especially with respect to health conditions for which certain populations have disproportionately negative outcomes.
Policymakers should expand and adequately fund opportunities to test the efficacy of health-promotion efforts and disease-prevention efforts across all care settings.
Best practices guidelines should be disseminated among states and localities.
Complementary and integrative medicines
Policymakers should support further study of the safety and efficacy of particular complementary and integrative medicine treatments.
Medical research on and use of cannabis
Older adults should be able to use medical cannabinoids, as allowed by state laws. This policy is intended to support the rights of older people to work with their health care providers to access cannabinoids for medical purposes in those states where such use has been approved.
Further clinical research on the medical use of cannabinoids to help alleviate both the symptoms of disease and the side effects of the treatment for diseases, particularly those that affect older adults such as cancer, Parkinson’s, Alzheimer’s disease and other dementias and multiple sclerosis, should continue.
The DEA’s classification of marijuana as a Schedule I controlled substance deters the medical use and scientific study of cannabinoids. Federal officials should examine options to allow THC, CBD and other cannabinoids for medical treatment and further clinical research.
Medical decisions about pain and symptom management should be made between the patient and his or her health care provider and appropriately balance clinical evidence of benefit and harm, the patient’s preferences and values and any laws that may apply.
Pain and behavioral modification research
The federal government should ensure that its research on pain management takes into consideration cultural differences in attitudes toward pain management. It should also consider racial and ethnic disparities in the use of pharmacological agents to control pain.
The federal government should fund research that examines all modalities of pain reduction, as well as modalities of nonpharmacological behavioral modifications such as those used to lessen anxiety and agitation related to dementia.
Focus on disparities
The federal government should ensure that all entities that are subject to the Affordable Care Act data collection requirement are in compliance.
The federal government should take steps to ensure that historically disadvantaged racial and ethnic groups, women, and older adults are included in federally funded research where feasible.
The federal government should monitor and make public the extent to which publicly sponsored research contributes directly to the development of commercial products by private entities.
Policymakers should ensure that the national research agenda, especially projects involving human subjects, is carried out with the highest ethical and safety standards. Clinical trials should include diverse populations, including older subjects, where appropriate.
In developing standards for collecting data on race, ethnicity, and primary language, the federal government should consider whether and how such methods as geocoding and surname analysis may be used. Standards should address when their use is contraindicated.