Containing America�s Opioid Crisis

�iStock/dptulkDrug overdose is the leading cause of unintentional injury deaths in the United States, and most of these deaths involve an opioid � a class of drugs that includes both prescription pain relievers, such as oxycodone, as well as the illegal drug heroin. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use says it is possible to stem the escalating prevalence of opioid use disorder and other opioid-related harms without foreclosing access to opioids for patients in pain whose providers have prescribed these drugs responsibly. It warns, however, that years of sustained and coordinated efforts will be required.

The report calls for a fundamental shift in the nation�s approach to prescribing practices as well as to improving awareness of the risks and benefits of opioids. It recommends promoting more judicious prescribing of opioids, expanding access to treatment for opioid use disorder, preventing more overdose deaths, implementing drug take-back programs, and investing in research to better understand the nature of pain and develop non-addictive drug alternatives. The report also recommends that the U.S. Food and Drug Administration weigh societal, not just individual, impacts of opioids in regulatory decision-making, as well as complete a review of the safety and effectiveness of all approved opioids.

FDA Commissioner Scott Gottlieb made a formal statement about the Academies� report, saying that the reduction of the scope of the opioid addiction epidemic is his highest immediate priority, and he asked his FDA colleagues to look at some key features of the agency�s regulation of opioids. Gottlieb also noted, as the report underscores, that the scope of the epidemic is going to require a coordinated effort that includes federal, state, and local partners to address properly the continued destruction of individual lives and families.

In addition to the Academies� study, which was funded by the U.S. Food and Drug Administration, the National Academy of Medicine also undertook a series of activities in response to the opioid epidemic, including a forum featuring Commissioner Gottlieb alongside U.S. Surgeon General Jerome Adams, Massachusetts Governor Charlie Baker, Miami-Dade County Court Judge Steven Leifman, and former HHS Secretary Kathleen Sebelius, and the special publication First, Do No Harm: Marshaling Clinician Leadership to Counter the Opioid Epidemic.

Health Effects of Marijuana and Derivative Products

�iStock/gaspr13Recent years have seen a rapid rise in the medical and recreational use of cannabis � such as marijuana and active chemical compounds known as cannabinoids. Shifting public sentiment, conflicting and impeded scientific research, and legislative battles have fueled the debate about what, if any, harms or benefits can be attributed to the use of cannabis or its derivatives.

The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research is one of the most comprehensive, in-depth reviews of scientific research on both the recreational and therapeutic uses of cannabis and cannabis-derived products. The report provides a broad set of evidence-based conclusions and makes recommendations to help advance the research field and better inform public health decisions. Out of nearly 100 conclusions, several have conclusive or substantial evidence of health effects.

One of the therapeutic uses of cannabis and cannabinoids is to treat chronic pain in adults, and patients treated with cannabis or cannabinoids were more likely to experience a significant reduction in pain symptoms, according to the report. For adults with multiple sclerosis-related muscle spasms, there is substantial evidence that short-term use of certain �oral cannabinoids� � man-made, cannabinoid-based medications that are orally ingested � improved their reported symptoms. Furthermore, in adults with chemotherapy-induced nausea and vomiting, there is conclusive evidence that certain oral cannabinoids are effective in preventing and treating those side effects.

The report also presents substantial evidence that cannabis use prior to driving increases the risk of being involved in a motor vehicle accident. Additionally, smoking cannabis during pregnancy is linked to lower birth weight. Evidence also suggests that greater frequency of cannabis use and initiating cannabis use at a young age both increase the likelihood of developing problem cannabis use.

The report recommends more research on the beneficial and harmful effects of cannabis and cannabinoid use, although there exist several challenges and barriers in conducting such research. For instance, specific regulatory barriers, including the classification of cannabis as a Schedule I substance, impede the advancement of research. Specifically, the report calls for government agencies to explore strategies to alleviate the current research barriers and to fund and support efforts to improve research quality and surveillance capacity.

The Academies� study was funded by Alaska Mental Health Trust Authority, Arizona Department of Health Services, California Department of Public Health, Centers for Disease Control and Prevention, CDC Foundation, U.S. Food and Drug Administration, Mat-Su Health Foundation, National Highway Traffic Safety Administration, National Cancer Institute, National Institute on Drug Abuse, Oregon Health Authority, Robert W. Woodruff Foundation, the Colorado Health Foundation, Truth Initiative, and Washington State Department of Health.

Making Medicines Affordable

�iStock/CatLaneMany medical conditions that were long deemed untreatable can now be cured or managed through the discovery and development of effective drugs. Yet spending on prescription drugs has been rising dramatically, to the point where many people have difficulty paying for the drugs that they or their family members need. Making Medicines Affordable: A National Imperative outlines eight recommendations along with 27 actions for their implementation to improve the affordability of prescription drugs without discouraging the development of new and more effective drugs for the future.

Congress should modify existing legislation to allow the U.S. Department of Health and Human Services to directly negotiate prices with producers and suppliers of medicines, including acting on behalf of any relevant state agency that elects to participate in the process, the report says. In order to accelerate the market entry and use of safe and effective generics and biosimilars (products that are demonstrated to be interchangeable with branded, FDA-approved products), the U.S. Department of Justice and the Federal Trade Commission should vigorously deter manufacturers from making �pay-for-delay agreements� � those in which they pay other producers of generics and biosimilars to delay their market entry.

To help understand the root causes of price increases and when they are appropriate, Congress should require disclosure of information from insurance plans about the average net prices paid for prescription drugs, including patients' cost-sharing among plans, and from biopharmaceutical companies about average net volume of and prices paid for drugs across each active sales channel.

Other changes the report says should be made to make medicines affordable are adopting industry codes of conduct and discouraging direct-to-consumer advertising of prescription drugs, modifying insurance benefit designs to mitigate drug cost burdens for patients, eliminating misapplication of funds and inefficiencies in federal discount programs that are intended to aid vulnerable populations, and ensuring that financial incentives to develop drugs for the prevention and treatment of rare diseases are not extended to widely sold drugs.

The Academies� study was funded by the American College of Physicians, Breast Cancer Research Foundation, Burroughs Wellcome Fund, California Health Care Foundation, the Commonwealth Fund, Laura and John Arnold Foundation, Milbank Memorial Fund, and the Presidents� Committee of the National Academies of Sciences, Engineering, and Medicine.

A Strategy to Eliminate Hepatitis B and C in the U.S.

Hepatitis B and C kill more than 20,000 people every year in the United States, and these infections also increase the risk of developing liver cancer. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report presents a strategy to eliminate these diseases in the United States as serious public health �iStock/RapidEyeproblems and prevent nearly 90,000 deaths by 2030.

The report stresses that the world already has the tools to prevent these deaths. Hepatitis B is preventable with vaccination, and recent advances in treatment make hepatitis C curable with short and easily tolerable courses of medicines. The number of deaths from hepatitis B could be cut in half by 2030 by diagnosing 90 percent of the nation�s chronic hepatitis B patients, bringing 90 percent of those to receive care, and treating 80 percent of those for whom treatment is warranted. Similarly, treating everyone with chronic hepatitis C would reduce new infections by 90 percent by 2030 and reduce hepatitis C deaths by 65 percent over the same time.

Eliminating hepatitis B and C as public health problems will require a significant departure from the status quo � including aggressive testing, diagnosis, treatment, and prevention methods, such as needle exchange. The report calls for a coordinated federal effort to manage hepatitis elimination and recommends expanding syringe exchange for people who inject drugs, free hepatitis B vaccine in pharmacies and other easily accessible places, and unrestricted treatment for everyone with hepatitis C.

Because the medicines that cure chronic hepatitis C are expensive, considerable attention was given to novel ways to pay for them. The report recommends a voluntary licensing agreement between the federal government and a patent-holding pharmaceutical company as a way to make the drug more affordable for Medicaid beneficiaries and other underserved patient populations.

The Academies� study was funded by the Centers for Disease Control and Prevention Division of Viral Hepatitis and Division of Cancer Prevention and Control; U.S. Department of Health and Human Services Office of Minority Health; American Association for the Study of Liver Diseases; Infectious Diseases Society of America; and the National Viral Hepatitis Roundtable.

A Blueprint for Better Health Care

�iStock/adamkazAmericans face many hurdles to obtain quality health care and maintain good health. Health system inefficiencies, high costs, and fragmented care place growing burdens on patients, families, businesses, and communities. Persistent health inequities remain across socio-economic and racial and ethnic lines and geographic locations. There are also complex public health challenges such as the opioid epidemic, obesity and related chronic diseases, and an aging population.

Vital Directions for Health & Health Care, a special publication by the National Academy of Medicine, provides a blueprint to tackle these national concerns and improve American health and health care. The publication is the culmination of an initiative that recruited more than 150 leading experts in health policy, science, and research over 18 months to examine the issues and propose the most promising opportunities for action.

The special publication compiles the initiative's collection of 20 expert papers, and includes overarching priorities laid out by a nonpartisan steering committee. The papers were informed by a national symposium and build upon lessons learned during previous health care reform experiences.

Achieving optimal health and health care for the United States requires commitment to three core goals: better health and well-being, high-value health care, and strong science and technology. Vigorous leadership is required from every quarter, beginning with federal initiatives, but ultimately anchored in strong efforts at the state and local levels.

To achieve these goals, the publication identifies four action priorities: ensure that payments reward affordable, high-quality care for all; empower people to be engaged in their health decisions; activate communities to mobilize resources and partnerships for health progress; and connect care by integrating services and seamless digital interfaces. Four priority infrastructure needs are also identified: consistent metrics to reduce reporting burdens and sharpen clinical performance; improved workforce skills for 21st century health care and biomedical science; real-world data derived from evidence from everyday experience; and advancement of research to cures.

The Academy's initiative was sponsored by the California Health Care Foundation, the Commonwealth Fund, Gordon and Betty Moore Foundation, John A. Hartford Foundation, Josiah Macy Jr. Foundation, Robert Wood Johnson Foundation, and the National Academy of Medicine�s Harvey V. Fineberg Impact Fund.

U.S. Role in Global Health

�iStock/courtneykFrom infectious disease pandemics such as the Ebola outbreak in 2014 to the silent killers of chronic noncommunicable diseases such as heart disease and diabetes, many health problems transcend national boundaries. Global Health and the Future Role of the United States examines national priorities in light of current and emerging global health threats and concludes that the U.S. should maintain its leadership position in global health efforts as matter of national interest and as a public benefit that also enhances America�s international standing.

The health and well-being of other countries directly and indirectly affect the health, safety, and economic security of Americans. The report says the United States must preserve and extend its legacy as a global leader, partner, and innovator in global health through forward-looking policies, a long-term vision, U.S. and international partnerships, and, most importantly, continued investment. Doing so will not only lead to improved health and security for all U.S. citizens but also ensure a sustainable and thriving global population. The report provides recommendations to the U.S. government and other stakeholders for increasing responsiveness, coordination, and efficiency in addressing health threats and challenges by establishing priorities and mobilizing resources. The recommendations focus on four priority areas for action:

  • achieve global health security,
  • maintain a sustained response to the continuous threats of communicable diseases,
  • save and improve the lives of women and children, and
  • promote cardiovascular health and prevent cancer.

While additional investment from the United States is required, more money alone is not the answer, the report stresses. One of the key recommendations of the report is to improve international emergency response coordination, noting that the U.S. alone committed $5.4 billion in response to the 2014 Ebola outbreak. Some additional recommendations for the U.S. include combating antimicrobial resistance, building public health capacity in low- and middle-income countries, envisioning the next generation of the President�s Emergency Plan for AIDS Relief, sustaining progress toward malaria elimination, ensuring healthy and productive lives for women and children, promoting cardiovascular health, preventing cancer, accelerating the development of medical products, transitioning investments toward global public goods, and committing to continued global health leadership.

The Academies� study was funded by the Centers for Disease Control and Prevention, U.S. Food and Drug Administration, National Institutes of Health, President�s Emergency Plan for AIDS Relief, U.S. Agency for International Development, Rockefeller Foundation, Medtronic, Merck Foundation, and BD (Becton, Dickinson and Company).

Dietary Guidelines for Americans

�iStock/AfricaImagesThe Dietary Guidelines for Americans (DGA) help Americans make informed decisions about what and how much they eat to improve their health and reduce the risk of chronic disease. Reviewed and updated every five years, the nutritional and dietary guidelines are the primary source of consistent, evidence-based information on dietary practices for optimal nutrition used to inform all federal nutrition policies and programs such as the National School Lunch Program and the Special Supplemental Nutrition Program for Women, Infants, and Children.

Redesigning the Process for Establishing the Dietary Guidelines for Americans finds, however, that the process used to develop these guidelines is not currently positioned to effectively adapt to changes such as food diversity and chronic disease prevalence while also ensuring the integrity of the process.

The U.S. Department of Agriculture and U.S. Department of Health and Human Services should conduct a comprehensive redesign of the process for updating the guidelines to increase transparency, promote diversity of expertise and experience, support a deliberative process, foster independence in decision-making, and strengthen scientific rigor, the report says.

In the past, USDA and HHS have relied on a Dietary Guidelines Advisory Committee (DGAC), a panel of nationally recognized experts, to develop the questions to be addressed and independently evaluate the scientific research. While the DGAC�s report advises the secretaries of USDA and HHS and does not constitute draft policy, it does serve as the scientific evidence base for updating the subsequent DGA. Optimizing the Process for Establishing the Dietary Guidelines for Americans: The Selection Process, the first report of this study released earlier in 2017, recommends ways to improve the selection process for the DGAC to provide more transparency, manage bias and conflicts of interest, and include committee members with a range of viewpoints.

Although USDA and HHS update the DGA every five years, the two-year DGAC term limit confines opportunities for a truly deliberative process with the nutrition community, technical experts, and the public, the report says. The tasks delegated to the DGAC should be redistributed into three separate groups to provide more targeted expertise: a Dietary Guidelines Planning and Continuity Group to monitor for and curate new evidence, identify and prioritize topics for inclusion in the DGA, and provide strategic planning support across DGA cycles; technical expert panels to provide content and methodological consultation during evidence evaluation; and a Dietary Guidelines Scientific Advisory Committee to interpret scientific evidence and draw conclusions.

Options for improving the process include providing a clear explanation when the guidelines omit or accept only part of conclusions from the DGAC scientific report, thereby enhancing transparency, the report says. Validated, standardized processes and methods with the most up-to-date data should also be used to strengthen the evidence base. All processes and actions should be based on the best available evidence, using the most advanced methods.

The report also recommends broadening the scope of the dietary guidelines to focus on the general public across the entire life span, including all Americans whose health could benefit by improving diet, and not just healthy Americans ages 2 years and older. It also notes that not all topics need to be reviewed each cycle.

Based on the report recommendations, USDA and HHS made changes to their process, identifying topics and questions to be addressed in the 2020-25 DGA, which are posted for public comment. The 2020-25 DGAC will be selected based on the final topics and questions.

The Academies� study was funded by the U.S. Department of Agriculture.