Policy Matters: September 2020 |
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COVID-19 RESPONSE:
HEALTH POLICY IN ACTION
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NATIONAL
Reinforcing Trust in the FDA and Its Vaccine Development Process
Center Director Mark McClellan testified before the before the House Energy and Commerce Subcommittee on Oversight and Investigations on September 30. Echoing the comments of six other former FDA commissioners in a Washington Post op/ed, Mark underscored that “the FDA has set the global gold standard on issues of medical product safety and effectiveness and has unparalleled experience and expertise in regulating vaccines that are used safely and effectively by hundreds of millions of Americans.” However, he pointed out, “vaccines are only effective to the extent they are used” and cautioned against recent political actions that “have created uncertainty for the public that has diminished confidence in the FDA and in vaccine development.” He noted a recent Pew Research Center poll that found 49 percent of respondents are unwilling to be vaccinated today if a new vaccine were available, a 22 percent increase since Pew surveyed vaccine attitudes in May 2020. Read the testimony and view the hearing.
Recent Wall Street Journal op/eds from Mark and former FDA Commissioner Scott Gottlieb further emphasized the integrity of the FDA and its vaccine review process. Read the 9/20 and 9/27 op/eds.
Center Director McClellan also addressed vaccine safety at a Duke University media briefing with Duke faculty colleagues Lavanya Vasudevan, Assistant Professor of Community and Family Medicine and Assistant Research Professor of Global Health, and Tom Denny, Chief Operating Officer of the Duke Human Vaccine Institute and a Professor of Medicine in the Department of Medicine. Read coverage in Duke Today, the Duke Chronicle, CNN, and FOX.
Early this month, Duke-Margolis issued a new report developed with the Rockefeller Foundation that provides a framework for public health officials and community leaders in schools, businesses and other institutions on how to use Covid-19 screening test strategies to operate safely and prevent further spread of the virus. The report aims to be a useful tool to help officials customize screening strategies of asymptomatic people to local circumstances and risk – with a particular focus on higher-risk populations and suppressing community spread. Read the report.
Duke-Margolis also hosted a webinar, “Safe and Effective COVID-19 Vaccination: The Path From Here” which featured a newsworthy fireside chat at the webinar with Peter Marks, director of the FDA Center for Biologics Evaluation and Research (CBER), and Margaret (Peggy) Hamburg, National Academy of Medicine and former FDA Commissioner on FDA’s role in ensuring that COVID vaccines are safe and effective. The event also address key questions and concerns related to the equitable distribution and access to vaccines once they are available, with particular consideration for high-risk and minority populations suffering disproportionately from the virus. View the webinar.
A Friends of Cancer Research event featured a fireside chat with Mark and FDA’s Drs. Janet Woodcock and Peter Marks on COVID-19 vaccine and therapeutic development. Dr. Woodcock estimated that only six percent of “trial arms” underway for COVID-19 will “yield actionable data.” View the event.
Center Deputy Director, Policy, Marta Wosińska discussed US trends in COVID-19 virus spread on North Carolina’s WRAL. View the clip.
Center Director Mark McClellan spoke to the National Association of Accountable Care Organizations at its 2020 virtual fall conference, noting that value-based payment models have enabled providers to respond better and more rapidly to the COVID-19 crisis than fee-for-service practices. Read more on the issue in Medical Economics and in Health Evolution.
STATE
Duke University School of Medicine Dean Mary Klotman interviewed Barton Haynes, Director of Duke’s Human Vaccine Institute and Center Director Mark McClellan on progress and challenges for COVID-19 vaccine development.
Core Faculty Member Don Taylor comments on the governor’s race in North Carolina and the impact of COVID. Read the article.
UNIVERSITY-FOCUSED
Core Faculty Member Gavin Yamey talked with several news outlets about US universities opening and the challenges of COVID-19, including the BBC, Bloomberg, and TNT World. He also co-authored a British Medical Journal editorial on re-opening universities at high risk.
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GLOBAL
Core Faculty Member Krishna Udayakumar discussed Pfizer’s role in supporting global health innovation and the impact COVID-19 has had on entrepreneurs around the globe. Watch the interview.
RESEARCH
The Duke-Margolis issued a new report, “Recommended Post-Market Incentive Strategies to Support the Development of Innovative Antibiotics,” co-authored by Managing Associate Monika Schneider, Senor Research Assistant Nicholas Harrison, and Center Director Mark McClellan. Read the report and coverage of it by the Center for Infectious Disease Research and Policy.
The COVID-19 Symptom Challenge submission deadline has been extended to Monday, October 6, 2020 11:59 PM ET. The Challenge seeks novel analytic approaches that use the Carnegie Mellon/University of Maryland COVID-19 Symptom Survey data to enable earlier detection and improved situational awareness of the outbreak by public health authorities and the general public. Learn more about the Challenge and read USA Today coverage here.
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12th ANNUAL SENTINEL INITIATIVE PUBLIC WORKSHOP
Duke-Margolis will host the 12th Annual Sentinel Initiative Public Workshop via virtual webinar on October 14, from 1:00-4:00 pm. The Sentinel Initiative, an active FDA medical product surveillance system, has become one of the Agency’s premier evidence generation platforms. This workshop provides an opportunity to discuss recent achievements and developments and engage with the broader community of patients, consumers, and scientific stakeholders. It will feature a keynote by FDA’s Dr. Patrizia Cavazzoni as well as presentations from numerous expert panelists who will provide updates on key Sentinel Initiative developments, milestones, and strategic aims. Register here.
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Senior Policy Fellow Susan Dentzer presented at the Center for Health Design's virtual workshop on telemedicine, "The Genie's Out of the Bottle," on the implications for telehealth use during and after the pandemic. Listen to the recording. She also moderated a discussion at the 2020 Pittsburgh Business Group on Health Virtual Symposium on top issues for employers during the pandemic. Learn more here. Susan also addressed "Vertical Integration and Value" on a panel Moss Adams 2020 Health Care Executive Webcast Series. Watch the webcast.
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Core Faculty Member Courtney Van Houtven has joined the Editorial Advisory Board of Milbank Quarterly for a three-year term.
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Luke Durocher has joined the Center as its Events and Marketing Manager, where he is responsible for planning, financial management, promotion, and effective execution of events associated with Duke-Margolis. In addition, Luke is the marketing lead for the Center’s events and new products and ensures promotion of Duke-Margolis research, project work, white papers, and other deliverables through both Center and University communications channels.
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Katie Greene re-joins the Center as a Visiting Policy Associate. Katie will work closely with Hemi Tewarson in expanding the Duke-Margolis state policy portfolio, especially to support the states’ response to COVID-19. She will also support the Center’s efforts in opioid use disorder (OUD) by leading a project on the topic and associated payment considerations for OUD care.
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The Rosalynn Carter Institute for Caregiving (RCI) has teamed up with researchers at Duke University to better understand the needs of unpaid caregivers across America. “This partnership provides a unique opportunity to use our collaborative research to quickly translate findings to on-the-ground programs that support family caregivers—a vital resource for long-term care. Our goals are to understand the experiences of vulnerable family caregivers, determine which caregivers will benefit from RCI’s programs, and builds ways to communicate important results to our program implementers and caregivers,” said Megan Shepherd-Banigan, Assistant Professor in Duke University’s Department of Population Health Science and School of Medicine and Duke-Margolis Core Faculty Member. Read more.
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Duke-Margolis and The Center for Innovation Policy at Duke University School of Law have issued a new guide on the use of artificial intelligence (AI) in health care. The report, “Trust, but Verify: Informational Challenges Surrounding AI-Enabled Clinical Decision Software,” which was funded by the Greenwall Foundation, is a resource for software developers, regulators, clinicians, policy makers, and other stakeholders on how to incentivize innovation of safe, effective AI-enabled medical products while communicating on how and when to use these products. The report is co-authored by Managing Associate Christina Silcox, Research Associate Isha Sharma, and Core Faculty Member Arti Rai, who published an accompanying article, “Accountability, Secrecy, and Innovation in AI-Enabled Clinical Decision Software,” in Duke Law. Read the report and the article.
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Core Faculty Members Megan Shepherd-Banigan and Courtney Van Houtven co-authored, “Family caregivers of Veterans experience high levels of burden, distress and financial strain”, published in the Journal of the American Geriatrics Society. Read the study
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Managing Associate Nirosha Mahendraratnam Lederer is a co-author of “Hypothesis Testing—Why, What, and How: Recommendations and a Road Map from the Real-World Evidence Transparency Initiative.” Read the article.
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