National Heart, Lung, and Blood Advisory Council February 2020 Meeting Summary

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

MEETING SUMMARY OF THE NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

February 11, 2020

The 286th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) was convened on Tuesday, February 11, 2020, in Building 35A, Room 610/620/630/640, at the National Institutes of Health (NIH), Bethesda, Maryland. It was open to the public from 8:10 a.m. to 11:10 a.m. The closed session began at 12:20 p.m. and ended at 1:30 p.m. Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), presided as Chair.

Council Members Attending

Dr. Dale E. Abe
Dr. Donna K. Arnett
Dr. Jennifer E. Devoe
Dr. Martha U. Gillette
Dr. Karen Glanz
Dr. Garth Graham
Dr. Luisa M. Iruela-Arispe
Dr. Monica Kraft
Dr. Mohandas Narla
Dr. Diane J. Nugent
Dr. Dean Sheppard
Dr. Kim M. Smith-Whitley
Dr. Kevin L. Thomas
Dr. Sally E. Wenzel
Dr. Andrew S. Weyrich

Council Members Attending via Teleconference

Ms. Grace Anne Dorney Koppel
Dr. Richard S. Schofield (Ex Officio)

NHLBI Employees Attending

A number of NHLBI staff members were in attendance.

Other NIH Employees Attending

Dr. Janine Clayton Director, Office of Research on Women’s Health, Office of the Director, NIH
Ms. Jamie White Office of Research on Women’s Health

Public Attending

Ms. Lisa Cash, BETAH Associates
Mr. Dale Dirks, Health and Medicine Council of Washington
Dr. Steven H. Woolf, Virginia Commonwealth University

I. WELCOME

Dr. Gary H. Gibbons called the 286th meeting of the NHLBAC to order and welcomed members and other attendees.

II. ADMINISTRATIVE ANNOUNCEMENTS

Dr. Laura K. Moen, Director of the Division of Extramural Research Activities, NHLBI, reported that two members whose terms were supposed to end in November 2019, Dr. Nugent and Dr. Smith-Whitley, had returned to NHLBAC for this meeting. NHLBI is identifying nominees for the Council for those whose terms conclude at the end of 2020.

Dr. Moen reminded Council members of the conflict of interest requirements. She also noted that the open portion of this meeting was being webcast and would be archived on the NIH videocasting website. She then reviewed the agenda.

III. REPORT OF THE DIRECTOR

Personnel Changes. Dr. Gary H. Gibbons announced that Dr. Nakela L. Cook, NHLBI’s Chief of Staff and Senior Scientific Officer, would be leaving the Institute to become the new executive director of the Patient-Centered Outcomes Research Institute (PCORI). Dr. Gibbons listed examples of Dr. Cook’s accomplishments at the Institute. Dr. Gibbons also reported the recent retirement of Dr. Donna DiMichele, who had served as the Deputy Director of the NHLBI Division of Blood Diseases and Resources.

American Heart Month. February was American Heart Month, which NHLBI would observe with the theme, “Our Hearts Are Healthier Together.” The messages around this theme focus on ways that people can stay healthy by helping each other.

Fiscal Stewardship. The president released his budget on February 10th. Dr. Gibbons reminded the Council that each year for the last 5 years, Congress had increased the NHLBI budget and hopes that this trend will continue. He noted that the President’s budget is often only the starting point for Congress’s budget negotiations.

In fiscal year (FY) 2020, the NHLBI budget rose by 4.1 percent. The appropriations bill encouraged the Institute to pursue chronic diseases and precision medicine, which are priorities in the Institute’s strategic plan.

NHLBI has Other Transaction Authority that allows it to invest in research programs through nimble funding mechanisms that are neither grants nor contracts. The Institute uses this authority to invest strategically in bold initiatives, including the Cure Sickle Cell Initiative and BioData Catalyst. Dr. Gibbons hoped to provide an update at NHLBAC’s June 2020 meeting on BioData Catalyst.

Support for Early Stage Investigators (ESIs). NHLBI’s policy of raising the payline by 10 percentile points for grant applications from ESIs continues to have the desired effect. In 2020, the success rates for ESIs continue to be the same as or higher than those for R01 applications from experienced investigators. In FY 2019, for example, the overall R01 application success rate was 23.5 percent, whereas the rate for ESIs was 29.2 percent. These successes are the result of the continued increases in the NHLBI budget over the last few years.

Promoting Diversity and Inclusive Excellence. Although fewer data are available on the racial and ethnic identities of applicants, trends are similar, with greater success rates for F and K awards to investigators from populations that are underrepresented in biomedical research and for R01 awards to ESIs than for R01s to established investigators. These trends for trainees and ESIs are promising. However, NIH and academic institutions need to nurture this pipeline and ultimately give female and underrepresented minority trainees academic jobs with startup packages.

Highlights from NHLBI’s Research Portfolio. Dr. Gibbons mentioned some of NHLBI’s specific investments in research that address its strategic vision include responses to current public health challenges:

• To address the public health threat from electronic cigarette use, for example, NHLBI is sponsoring projects that can provide insight into the constituents of the liquids in these products that affect lung health. The Institute is also offering supplements with other NIH Institutes and Centers (ICs) and working with other federal agencies to address this emerging crisis.
• Since 2010, all-cause mortality rates have been increasing in the United States, and life expectancy has been decreasing since 2017. This trend is driven by increased mortality rates in adults age 25–64 years. Studies show that midlife mortality rates have increased across all racial groups. Cardiovascular disease (CVD) rates are highest in blacks, followed by American Indians and Alaska Natives. Although CVD mortality rates have declined in most groups, they have increased in American Indians and Alaska Natives age 25–49 and plateaued in white women age 25–49. The Risk Underlying Rural Areas Longitudinal (RURAL) Cohort Study, funded by NHLBI, will enhance understanding of this adverse CVD pattern.
• To help realize the promise of precision medicine, NHLBI is supporting data science research and the development of expertise in this field. The hope is to use machine learning, artificial intelligence, big data, and other new tools and resources to address important health research challenges. With NHLBI’s support, experienced investigators can learn how to use these new tools and technologies, and research teams can add data scientists, computational biologists, and systems medicine experts to tackle heart, lung, blood, and sleep research questions.
• NHLBI is contributing to a trans-NIH effort to improve women’s health and, especially, to reduce the disturbing rates of maternal morbidity and mortality. Coagulation and bleeding complications play a major role in this crisis. Women from rural areas and those of low socioeconomic status have a higher risk of CVD, maternal morbidity and mortality, and preeclampsia. Making a difference in this disturbing public health challenge aligns with the Institute’s interest in special populations, health disparities, and social determinants of health.

IV. MATERNAL MORTALITY: WHAT DO WE KNOW, AND HOW IS NIH ADDRESSING IT?

Dr. Janine A. Clayton, NIH Associate Director for Research on Women’s Health and Director of the NIH Office of Research on Women’s Health (ORWH), summarized data from three reports on maternal mortality released by the National Center for Health Statistics on January 30, 2020. According to these reports, maternal mortality rates vary dramatically by race and ethnicity, and these rates are much higher in the United States than in other countries in the Organisation for Economic Co-operation and Development (OECD). U.S. rates have been increasing since 1990, during a period when rates have declined in other high-income countries. She specifically noted:

• The leading causes of maternal mortality differ by phase. During pregnancy, for example, the main causes are cardiovascular and noncardiovascular conditions and infections. Within the first 6 days after delivery, the leading causes are hemorrhage, hypertensive disorders of pregnancy, and infection. Approximately 50 to 60 percent of maternal deaths are preventable.
• Although pregnancy occurs only a few times in a woman’s life, it influences her health for the rest of her life. A woman’s health status before she becomes pregnant is an important parameter. For example, maternal morbidity rates are higher in women with depression or preeclampsia before pregnancy, and women with gestational diabetes mellitus have an increased risk of developing hypertension.

NIH Activities. In 2019, NIH invested $325 million in research on maternal health, including studies on preeclampsia, perinatal care, mental health, and cesarean delivery. The Task Force on Research Specific to Pregnant Women and Lactating Women, established by the 21st Century Cures Act, advises the Secretary of Health and Human Services (HHS) on research gaps pertaining to safe and effective therapies for pregnant and lactating women. The task force is chaired by the director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The task force published a report in September 2018 with 15 recommendations, and it is developing implementation plans for each recommendation.

Dr. Clayton also co-chairs the NIH Maternal Mortality Task Force, which recently issued a request for information to collect comments about a proposed research initiative to decrease maternal mortality rates. Responses (due by February 21, 2020) and she encouraged NHLBAC members to submit comments and to encourage their colleagues to do so.

NIH plans to observe National Women’s Health Week, May 12-18, 2020, with a workshop, sponsored by NHLBI and NICHD, on pregnancy and maternal conditions associated with an increased risk of morbidity and mortality. Participants will discuss the fact that compared with women in the 1970s, women today are likely to be older and to have hypertension, obesity, and type 2 diabetes before pregnancy; these factors contribute to morbidity and mortality. The feedback from this meeting may help to develop a research plan.

A plan for 2019–2023, Advancing Science for the Health of Women: Trans-NIH Strategic Plan for Women’s Health Research, offers several strategic goals, such as advancing rigorous research that is relevant to women’s health and enhancing dissemination and implementation of evidence to improve women’s health. A multidimensional framework represents the complex intersection of internal factors (e.g., sex influences at genetic, molecular, cellular, and physiological levels) and external factors (e.g., gender, social determinants of health, environmental factors, policies) that affect women’s health throughout the life course.

ORWH is also committed to helping women in science reach their full potential. For example, 26 NIH ICs, including the NHLBI, have supported new Notices of Special Interest that provide time and funding for investigators to continue their work after a qualifying event, such as giving birth. The goal is to keep these women in science so they can reach their full potential. ORWH also is developing a new course on how to integrate sex and gender into research to improve human health.

Dr. Clayton ended her remarks by pointing out that structural racism has an impact on maternal morbidity and mortality rates because some of the experiences of women of color before pregnancy affect their pregnancy outcomes. Standardized approaches using new technologies (such as clinical decision support tools in electronic medical records) are needed to ensure that every woman receives evidence-based care at every therapeutic interaction.

V. THE DECLINE IN U.S. LIFE EXPECTANCY AND THE INCREASE IN MIDLIFE MORTALITY: POTENTIAL EXPLANATIONS AND RESEARCH PRIORITIES

Dr. Steven H. Woolf, Director Emeritus, Center on Society and Health, and Professor, Department of Family Medicine, Virginia Commonwealth University, reviewed research about U.S. life expectancy. During his presentation, he noted several important points:

The pace of gains in life expectancy for women and men in the United States began to slow down in the 1980s.

• In 1998, life expectancy rates dropped to below those of other OECD (Organisation for Economic Co-operation and Development) countries, and these rates have continued to decline.
• Death rates from most causes are higher in the United States than in other high-income countries. These causes include ischemic and hypertensive diseases, accidental poisoning (including drug overdose), suicide, and diseases of the respiratory and nervous systems. U.S. death rates are lower than in peer countries for only a few causes, including cancer and cerebrovascular diseases.
• A report published in the November Journal of the American Medical Association which showed that mortality rates in the United States are declining for infants, adolescents, and older adults. However, the pattern is very different for adults age 25–64. Starting in 2010, a period of declining all-cause mortality rates ended for this age group, and rates began to climb. The problem did not begin in 2010 but increases in mortality rates in this age range previously had been offset by other factors, such as declines in cancer and ischemic mortality.
• There was progress in reducing all-cause mortality rates among non-Hispanic blacks, but that trend is being reversed. All-cause mortality rates are increasing in all racial and ethnic groups. Drug overdose is a major contributor to this phenomenon, but alcohol use and suicide also play a role. For this reason, this phenomenon has been labeled “deaths of despair.” However, the trend is much broader because mortality rates have increased for 35 causes of death—including hypertensive and chronic lung diseases—in adults age 25–64. Furthermore, progress in reducing ischemic heart disease mortality has leveled off, probably because of increases in mortality rates due to hypertensive heart disease, chronic heart failure, and valvular heart disease.
• Four states in the Ohio Valley account for one-third of the excess deaths in adults age 25–64 since 2010, and half the excess deaths were in Appalachian states. Major health inequities play a role, but the greatest increase in midlife mortality rates is in whites, so inequities are not the only factor at play. One explanation could be rates of substance abuse that are much greater than in peer countries. Although tobacco use is still a major cause of death, smoking rates have been declining, and adults in midlife today are less affected than older adults by the increased smoking rates in the 20th century. Obesity probably plays a role, as does lack of access to health care for some groups. The fact that the age groups with access to health care coverage provided by federal programs (i.e., children, older adults) are not experiencing increases in all-cause mortality rates shows that lack of health care coverage does explain some of the increase.

Dr. Woolf pointed out that chronic stress is bad for health, and noted that people who are exposed to stress chronically turn to unhealthy coping behaviors, such as overeating and using drugs and alcohol. The increases in mortality rates in the Rust Belt and Appalachia—which began in the 1970s, 1980s, and 1990s—could be tied to losses of manufacturing jobs in these communities and the resulting long-term unemployment, stagnant wages, and social immobility. The differences among regions also could reflect different policy choices in different states that had an impact on health.

Finally, Dr. Woolf identified several research gaps, including the need to identify the etiology of cause-specific mortality increases, the reasons for women’s health disadvantage, and the role of social and economic distress.

Dr. George Mensah, Director of the NHLBI Center for Translation Research and Implementation Science, pointed out that many causes of increased death rates are in areas that have had major breakthroughs, but the results of this research have not been implemented. Dr. Woolf said that closing the gap between clinical guidelines and the care delivered would save more lives than new drugs. The U.S. population lacks access not only to advanced-level care, but also to basic care.

VI. DELEGATION OF AUTHORITY

Delegated authorities allow NHLBI staff to perform specific functions without Council involvement, adding flexibility and decreasing the burden on the Council. NHLBAC members approved the delegated authorities presented, with no changes.

CLOSED PORTION

This portion of the meeting was closed to the public in accordance with the determination that it concerned matters exempt from mandatory disclosures under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 10(d) of the Federal Advisory Committee Act, as amended.

VII. REVIEW OF APPLICATIONS

The session included a discussion of procedures and policies regarding voting and confidentiality of application materials, committee discussions and recommendations. Members absented themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect. The Council considered and recommended 3,145 applications requesting $6,917,332,242 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

ADJOURNMENT

The meeting adjourned at 1:30 p.m.