National Heart, Lung, and Blood Advisory Council February 2019 Meeting Summary

DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH
NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

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

February 5, 2019

The 281st meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) was convened on Tuesday, February 5, 2019 in Building 35A, the Porter Neuroscience Center Conference Center, National Institutes of Health (NIH), Bethesda, Maryland. It was open to the public from 8:35 a.m. until 11:10 a.m. Closed session began at 12:15 p.m. and ended at 1:15 p.m. Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), presided as Chair.

Council Members attending

Dr. E. Dale Abel
Dr. Jennifer DeVoe
Ms. Grace A. Dorney Koppel
Dr. Martha Gillette
Dr. Karen Glanz
Dr. M. Luisa Iruela-Arispe
Dr. Monica Kraft
Dr. Mohandas Narla
Dr. Diane J. Nugent
Dr. Dean Sheppard
Dr. Kim M. Smith-Whitley
Dr. Kevin Thomas
Dr. Sally E. Wenzel
Dr. Andrew S. Weyrich

Council Members attending via Teleconference

Dr. Garth Graham
Dr. Richard S. Schofield (ex officio)

Council Members unable to attend

Dr. Donna K. Arnett
Dr. Robert C. Robbins

Ad Hoc Members attending

Dr. Victor Thannickal

Public attending

Ms. Tawanna Berry, Westat
Mr. Austin Booth, RTI International
Mr. Joshua Lewis, Health and Medicine Counsel of Washington
Ms. Nuala Moore, American Thoracic Society
Ms. Terry Savage, Westat

NHLBI employees attending

A number of NHLBI staff members were in attendance.

Other NIH Institute employees attending

Dr. Margaret Bevans, ORWH, NIH
Dr. Gretchen Buckles, ORWH, NIH
Dr. Gene Carstea, CSR, NIH
Dr. Janine Clayton, ORWH, NIH

I. CALL TO ORDER AND OPENING REMARKS

Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), called the meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) to order and welcomed members and other attendees.

II. ADMINISTRATIVE ANNOUNCEMENTS

Dr. Laura K. Moen, Director, Division of Extramural Research Activities, NHLBI, made the required announcements for the Council meeting, including the publication of a notice in the Federal Register as well as reminders to Council members regarding conflict of interest and lobbying activities.

III. REPORT OF THE DIRECTOR

New Members. Dr. Gibbons welcomed the newest Council members: Drs. Jennifer DeVoe, Martha Gillette, Mohandas Narla, and Kevin Thomas. He noted that the new members reflect the Institute’s commitment to diversity of gender, race, geography, and discipline.

Leadership Change. Dr. Gibbons announced the upcoming retirement of Dr. Michael Engelgau, Deputy Director of the NHLBI’s Center for Translation Research and Implementation Science. Dr. Gibbons recognized Dr. Engelgau’s contributions to the NHLBI as a great leader and colleague.

NHLBI Budget and Expenditures. The NHLBI received its fiscal year (FY) 2019 appropriation from Congress at the start of the year, on October 1, 2018, and it was minimally affected by the recent partial government shutdown. The Institute’s FY 2018 budget increase allowed the NHLBI to issue more awards for investigator-initiated science.

Involvement in Trans-NIH Initiatives. When trans-NIH initiatives align with the NHLBI’s portfolio and vision, the Institute seizes these opportunities. For example, the NHLBI participates in the NIH Helping to End Addiction Long-term (HEAL) Initiative by cosponsoring, with the National Institute on Drug Abuse, a request for applications, Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder and Response to Medication Assisted Treatment. As part of the Investigation of Co-occurring Conditions Across the Lifespan to Understand Down Syndrome, the NHLBI supports research on such topics as cell signaling mechanisms in cardiomyogenesis as well as on congenital heart defects in people with Down syndrome. Understanding these issues in Down syndrome might shed light on congenital heart disease in the broader population.

Women’s Health Research. Dr. Gibbons reported on NHLBI activities related to women’s health research, which address the NHLBI’s strategic objectives. Recent NHLBI-sponsored research on women’s health has produced a number of findings. For example: the risk of coronary artery disease is four to five times higher in women than men with diabetes; the prevalence of hypertension is greater in older women than men; women tend to have more end-organ complications of hypertension than men; 40% of U.S. women are obese compared with 35% of men; and the women in the heaviest category of obesity have a fourfold higher risk of cardiovascular events.

Gender Balance in the Biomedical Research Workforce. Funding rates for research program grant applications from women continue to be somewhat lower than for applications from men. The proportions of women and men who receive NHLBI research funding need to reflect the proportions in the population.

Precision Medicine. The NHLBI continues to leverage new technologies—including data science, artificial intelligence, and precision medicine—for research on cardiovascular disorders. For example, research using Trans-Omics for Precision Medicine (TOPMed) showed an association between titin loss-of-function variants and early-onset atrial fibrillation. In addition, genome-wide polygenic scores for common diseases identify individuals with a higher risk of coronary artery disease. The June NHLBAC meeting will include an update on NHLBI’s cloud-based Storage, Toolspace, Access, and Analytics for Big-Data Empowerment (Data STAGE). This resource will offer a secure, collaborative workspace with tools, applications, and workflows.

American Heart Month. February is American Heart Month, and the theme is Our Hearts Are Healthier Together. The NHLBI encouraged Council members to spread the word about this initiative and to challenge themselves and their colleagues to adopt heart-healthy lifestyles.

IV. GETTING TO THE HEART OF RESEARCH TO ADVANCE THE HEALTH OF WOMEN

Dr. Janine Clayton, NIH Associate Director for Research on Women’s Health and Director of the NIH Office of Research on Women’s Health (ORWH), began her presentation with some startling statistics.

Women’s Health. The gap between life expectancy for women and men in the United States continues to lag further behind than in other high-income countries, partly because of the opioid epidemic. In addition, the maternal mortality rate is rising in the United States, and this rate more than doubled in the last 15 years, even though it is decreasing in peer and developing countries.

Women and Minority Populations in Clinical Research. Appropriate inclusion of women and other populations that are underrepresented in biomedical research is essential for obtaining robust findings that are applicable to the populations experiencing disease. The inclusion of women and people of different races and ethnicities in randomized controlled trials is an important step forward, but only if these data are analyzed and reported. Sex differences in reference values and biomarkers for diagnosis and prognosis are critical to improve clinical trial design and advance health care.

ORWH partnered with the FDA Office of Women’s Health to develop the NIH Outreach Toolkit for engaging, recruiting, and retaining women in clinical research (https://orwh.od.nih.gov/toolkit/home). This resource offers information on NIH policies on inclusion, case studies, literature reviews, and guidance for principal investigators.

Improving Women’s Health. Improving women’s health is a trans-NIH priority, and ORWH works with all 27 Institutes and Centers to achieve this goal. The 2019–2023 Trans-NIH Strategic Plan for Research on Women’s Health has five strategic goals and will soon be available on the NIH website.

NHLBI Research on Sex and Gender. The NHLBI integrates sex and gender considerations throughout its strategic vision. The NHLBI Women’s Health Working Group considers the health of women across the entire NHLBI portfolio. ORWH has funded 28 administrative supplements (out of a total of 40) for NHLBI-funded studies to support research highlighting the impact of sex and gender influences in human health and illness.

Upcoming ORWH Events. Upcoming ORWH-sponsored events include a National Academy of Sciences symposium on March 11, 2019, on the underrepresentation of women in science, technology, engineering, mathematics, and medicine at pivotal career stages. This symposium is part of a National Academy of Sciences initiative that will issue a report in March 2020.

V. TRIENNIAL INCLUSION REPORT

Dr. Gail Pearson, Director, NHLBI’s Office of Clinical Research, explained that NIH reports data on the inclusion of women and minorities in clinical studies to Congress every 3 years. The Council must certify that the NHLBI is complying with its requirements to provide information for the report.

Legislation, Policy, and Procedures. The NIH Revitalization Act of 1993 required the inclusion of women and minorities in all clinical research unless a compelling rationale exists for their exclusion. The act also requires Phase III clinical trials to conduct analyses by sex and gender, race, and ethnicity where appropriate. To implement this legislation, NIH has issued policy and guidelines that ensure that individuals are included in clinical research in a manner that is appropriate to the scientific question being studied. The 21st Century Cures Act of 2016 updated the NIH inclusion policy and procedures. Now, Phase III clinical trials must report results of valid analyses by sex and gender, race, and/or ethnicity in Clinical Trials. In addition, the legislation mandated the Inclusion Across the Lifespan workshop, which took place in June 2017, and triennial inclusion reporting. On January 25, 2019, NIH revised its policy on inclusion across the lifespan to expand inclusion reporting to all ages, clarify acceptable reasons for exclusion, and require annual reporting of deidentified, individual-level participant data.

NHLBI Strategic Vision Focus on Inclusion. An NHLBI strategic vision objective is to investigate factors that account for differences in health among populations. Before funding research, the NHLBI determines whether the enrollment plan is justified based on the scientific goals and research strategy and whether the proposed proportion of women, minorities, and relevant age groups match their prevalence for the disease or condition being studied. NHLBI staff use annual progress reports to determine whether study enrollment is meeting the targets in the study plan.

A request for information (RFI) NOT-HL-18-660: Understanding The Health of Women and the Role of Sex and Gender in Mechanisms of Heart, Lung, Blood, and Sleep Diseases and Disorders sought feedback by March 15, 2019, members were encouraged to review and provide comments. A congressional briefing on February 26, 2019, addressed the history of women in heart research starting with the Framingham study.

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 3,296 applications requesting $4,926,544,952 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

ADJOURNMENT

The meeting was adjourned at 1:15 p.m.