HEALTH POLICY IN ACTION

Duke-Margolis issued a new paper, Reducing Global COVID Vaccine Shortages: New Research and Recommendations for US Leadership, that states just four nations or regions with less than half the world’s population are administering 70 percent of all COVID-19 vaccine doses, while the poorest countries have barely begun vaccinating due to lack of funding and supply. The U.S. alone is expected to have 300 million excess doses of vaccine by the end of July 2021.

Core Faculty members Mark McClellan and Krishna Udayakumar join Duke co-author Michael Merson, and Gary Edson, President of the COVID Collaborative to outline a three-part plan to strengthen U.S. leadership for safe, effective, and equitable global vaccine access, including: strengthening COVAX; developing plan to make excess vaccine doses available as soon as possible; and increasing reliable vaccine production worldwide through public-private partnerships with experienced manufacturers. The President’s Emergency Plan for AIDS Relief (PEPFAR) could provide a model for U.S. leadership to globalize safe and effective COVID-19 vaccination. This work spurred a New York Times editorial and an op/ed by the authors in POLITICO. Read the editorial and the op/ed.

Center Director Mark McClellan and Scott Gottlieb published a Wall Street Journal commentary that calls for the development of a safe and effective COVID drug that could be taken at home to stop the infection from progressing. Ideally, a small-molecule drug could block some of the core machinery that the virus uses to replicate, and thus may be able to elude the type of variants that are currently challenging the U.S. and the world. Development of and investment in therapeutics of this kind hold potential to arrest entire classes of viruses to protect against future pandemics. Read the full commentary.

Center Director Mark McClellan discusses with Health Evolution the effects of the American Rescue Plan on health care in America and how, “aside from the COVID emergency funds, [the bill] took steps in making health care more affordable.” Read more here.

Duke-Margolis researchers and policy experts Katie Greene, Katie Huber, Hemi Tewarson, and Mark McClellan, in partnership with COVID Collaborative, issued a new white paper, “Building Public-Private Partnerships to Support Efficient and Equitable COVID-19 Vaccine Distribution, Access, and Uptake.” With an increasing supply of vaccines, the current emphasis on quickly administering vaccines not only needs to continue to scale up; it also needs to focus on groups that are less willing or able to be vaccinated, and on building a data and public health infrastructure that can support potential booster shots and future vaccination efforts. Read the full report.

The confluence of rising health expenditures and the pandemic’s disruption to the health care system

may catalyze greater interest in value-based payment (VBP) arrangements. However, the path forward is challenging and complex.

In October 2020, Duke-Margolis and the National Governors Association Center for Best Practices hosted an expert roundtable to discuss the state role in accelerating the transition to value post-COVID-19. The resulting issue brief summarizes four key areas where states can foster greater adoption of VBP, including establishing a long-term vision, working toward simplifying participation in VBP models; convening public and private sectors to develop a coordinated vision, and ensuring access to timely and accurate information to monitor quality and make improvements. Read the issue brief.

Duke-Margolis faculty and researchers David Anderson, Jessica Beliveau, Laura Benzing, Janet Prvu Bettger, Rebecca Whitaker, and Charlene Wong, as well as other authors from Duke University, Boston University, and UNC-Chapel Hill sought to understand how Medicaid reform can affect health for low income, vulnerable North Carolinians. The team conducted three related statewide projects that collected baseline data and monitored three key domains where there was a potential for widening health disparities as North Carolina shifts to Medicaid Managed Care (MMC). Below are links to each of the fact sheets that their work produced:

Core Faculty Member Nathan Boucher and Duke undergrad Aditya Santoki co-authored “Investigating Barriers to Vaccination Among Durham County’s Vulnerable Populations,” exploring motivations for those seeking vaccines in a public health clinic and how those findings can inform our response to the COVID-19 vaccination process. Read more here.

RESEARCH

When the U.S. adopted legislation to create a process for regulating and approving biosimilars in 2010, the law raised expectations that billions of dollars would be saved annually as multiple competitor biologics came onto the market at prices below those of the original drugs. More than a decade later, the promise of biosimilars in the U.S. has not fully lived up to these expectations for a host of complex reasons. Other countries, most notably in Europe, have moved more quickly to adopt biosimilars, and now have more biosimilars on the market and in broad use.

A new Duke-Margolis paper explores what might be learned from applying the European experience to the U.S. setting, and provides potential steps to increase the pace of biosimilars approvals and expand their use in the U.S. Read the paper.

Core Faculty Member Nathan Boucher co-authored “The Future of Caregiving through Virtual Online Communication,” with Duke undergraduate Emma Dries investigating how virtual communication is now a norm and is changing the face of formal and informal caregiving for older Americans and those in long-term care. Read the full paper here.

Duke-Margolis Core Faculty Member Frank Sloan authored “Quality and Cost of Care by Hospital Teaching Status: What Are the Differences?” evaluating empirical evidence on relative quality and cost of teaching hospitals and assessing what the findings indicate for public and private insurer policy. Read the full paper here.

Center Team Members Mira Gill, Laura Benzing, and Mark McClellan published an article entitled "Understanding Use of Real-World Data (RWD) and Real-World Evidence (RWE) to Support Regulatory Decisions on Medical Product Effectiveness" in Clinical Pharmacology and Therapeutics. The article was highlighted in the AgencyIQ newsletter in the "What we're watching and reading" section. Read the article here.

Managing Associate Sarah Sheehan co-authored “Prospect of Direct Benefit in Pediatric Trials: Practical Challenges and Potential Solutions.” Funded by FDA, the paper outlines several approaches to maximizing prospect of direct benefit for pediatric trial participants, minimizing unnecessary risks and burden, and facilitating timely access to safe and effective medicines for children. Read the paper here.

EDUCATION

Margolis Scholars brought together local and national experts to discuss longstanding racial health inequities that were highlighted by the 2020 COVID pandemic. The webinar “Then and Now: The Importance of Historically-Informed Approaches to Addressing Racial Health Inequities in Responding to COVID-19,“ included panels focused on vaccine distribution, social contributors of health, and healthcare delivery changes. Panelists, including Center Health Equity Policy Fellow Andrea Thoumi, explored the history that has led to the medical system losing the trust of many from marginalized racial and ethnic communities as well as the role of medical racism, through interpersonal, institutional, and systemic racism, that has not only prevented marginalized communities from receiving quality care, but also, in many instances, actively led to their harm and death. Read coverage of the event here. 

Read profiles of the two graduates of Duke-Margolis and how the Center and their participation in Duke’s Bass connections launched their careers in health policy.

Applications for the Margolis Scholars Program in Health Policy and Management is now open. Applications are being accepted from graduate students in the following programs: incoming Master’s students in Public Policy, Business, Science & Society, Global Health, Population Health Sciences, Engineering, Nursing (DNP), and Environment and current students in Law, Nursing, and Public Policy. The Margolis Scholars application will be open until May 2nd at 11:59 PM EST. Find more information about the program on our here.

Margolis Scholar Keren Hendel was selected as a finalist for the Bass Connections Award for Outstanding Mentorship and Health Equity Policy Fellow Andrea Thoumi was selected as finalist for the inaugural Bass Connections Leadership Award for their work on the Bass Connections course Community-Based Testing and Primary Care to Mitigate COVID-19 Transmission.

Margolis Scholar Seve Gaskin was interviewed by Poets & Quants as part of its Meet the MBA Class of 2022 series. When asked which club or activity excited him the most at Duke, Seve answered The Duke-Margolis Center for Health Policy. Click here to find out more about this Margolis Scholar and why Duke-Margolis is so important to him.

Center Director Mark McClellan joined his fellow co-chairs of the Learning and Action Network at the CMS Quality Conference at a session that highlighted the development of the Healthcare Resiliency Framework, its support by industry leaders based and the initiative’s focus on resilience. Read more here. 

Join the Duke-Margolis Center for Health Policy - including The Honorable Michael Bennet (CO) and former FDA Commissioners Dr. Mark McClellan and Dr. Scott Gottlieb - for an important discussion on combating rising antimicrobial resistance (AMR) in the context of U.S. public health preparedness, support for novel antibiotics, global AMR policy leadership, and emerging multi-sector innovation. For more information and to register click here.

Center Director Mark McClellan will speak at the Fifth International Vatican Conference beginning virtually on May 6^th. The event “Exploring the Mind, Body & Soul,” will feature a panel discussion with Mark entitled “Shaping the Future of Health Care for a Healthier World.” Additionally, he will moderate the panel “Quelling the Quandary of Drug and Therapy Affordability for Chronic Diseases.” Advisory Board Member Rebekah Gee also is participating by offering her insights and perspectives on “An Innovative Model to Reform Drug Pricing.” For more information about the event click here.

Core Faculty Member Aaron McKethan, former Center staff Hilary Campbell, and the rest of their team from Health Care Cost Institute and Duke University were finalists in NIHCM’s 2021 Digital Media Awards for their report “A Multi-Payer Analysis of Health Care Spending in North Carolina.” For more about NIHCM and the other 2021 award finalists click here.

Margolis Scholar Jacqueline Nikpour, PhD, RN successfully defended her dissertation to obtain her PhD. Her work focused on comparing opioid and non-opioid prescribing patterns in chronic pain management by primary care physicians, NPs, and PAs in a national Veterans Affairs sample, as well as patient, provider, and system level factors influencing those patterns.

POLITICO interviewed Center Director Mark McClellan about how regulators’ jobs are changing, how the U.S. system is holding up, and how social media is being used to advocate for more research and to pressure FDA on new cures. Read the full article here.

Soon after the onset of the pandemic, Duke-Margolis Core Faculty Member Don Taylor along with fellow Duke researchers Rachel Kranton, Professors Tyson Brown and Duncan Thomas launched Project ROUSE (Reopen Our University Safely and Effectively). The study measures Duke employees’ experiences living and working through the pandemic in order to learn about effects on well-educated, working adults and their families. Read more about the program in the article from DukeToday.

Duke-Margolis welcomes two new members to its Core Faculty Team. Affiliated Faculty member Evan Myers joins the Center’s Core Faculty as a Professor of Obstetrics and Gynecology in the Duke School of Medicine with a focus on issues concerning women’s health. Shelley Hwang joins Duke-Margolis as a Professor of Surgery in the Duke School of Medicine with an oncology focus.

Core Faculty Member, Arti Rai has been appointed to serve as a senior advisor in the Office of General Counsel in the U.S. Department of Commerce. Read more here.

Marta Wosińska, Consulting Professor and the Center’s Deputy Director, Policy, has been appointed Director of the Bureau of Economics at the Federal Trade Commission. Her last day at Duke-Margolis was Friday, April 23^rd.

Throughout her tenure at the Duke-Margolis, a time of rapid growth for us, Marta worked to strengthen the resiliency of the Center’s research teams and capabilities, even as we extended those capabilities in the midst of the pandemic. Marta also made important health policy contributions during these critical times for health policy, including leadership of FDA convenings, in-depth policy analysis of monoclonal antibodies to treat COVID-19, and expanding the Center’s drug pricing, competition, and payment portfolio, including most recent opportunities regarding biosimilars.

We deeply appreciate Marta’s countless contributions to the Duke-Margolis during this most demanding time. Thanks in part to her efforts, we have a strong senior leadership team and are implementing a transition plan for Marta’s roles that will build on the Center’s growing infrastructure, resources, and momentum, and that reflects our enhanced scale and scope. I know you will join us in congratulating her on this next chapter of her career, as she continues to have important impacts on policy.

Thanks Marta!