Health Policy & Bioethics Consortia 2020-2021
PORTAL runs a monthly seminar series that convenes two experts from different fields or vantage points to discuss how various aspects of therapeutic development and use are affected by ethical norms, laws, and regulations. These are organized in conjunction with the HMS Center for Bioethics supported by the Oswald DeN. Cammann Fund at Harvard University.
You may join the discussion on Twitter before, during, or after each event by following @PORTAL_Research and using the hashtag #policyethx.
You may join the discussion on Twitter before, during, or after each event by following @PORTAL_Research and using the hashtag #policyethx.
The NFL, Youth Sport, and Concussions
November 13, 2020 | 12:30 - 2:00 PM ET
Webinar via Zoom (Register HERE)
Potential links between contact sports and chronic traumatic encephalopathy or other long-lasting neurological effects have received renewed public interest with high-profile lawsuits and debate about the dangers of sport. There are challenges with the evidence for drawing firm conclusions, making these debates especially contentious. The concerns about sport and head injury, especially for young players, are not new. Despite recognition of the dangers inherent in contact sports, there is a history of avoiding addressing the problem head-on. American culture surrounding football, lauded for its rough style of play, also influences our understandings of risk, injury, and changes to the sport.
November 13, 2020 | 12:30 - 2:00 PM ET
Webinar via Zoom (Register HERE)
Potential links between contact sports and chronic traumatic encephalopathy or other long-lasting neurological effects have received renewed public interest with high-profile lawsuits and debate about the dangers of sport. There are challenges with the evidence for drawing firm conclusions, making these debates especially contentious. The concerns about sport and head injury, especially for young players, are not new. Despite recognition of the dangers inherent in contact sports, there is a history of avoiding addressing the problem head-on. American culture surrounding football, lauded for its rough style of play, also influences our understandings of risk, injury, and changes to the sport.
|
EXPERTS:
Kathleen Bachynski, PhD, MPH
Grant Iverson, PhD
|
MODERATOR:
Cynthia Stein, MD, MPH
Attending Physician, Sports Medicine Division, Department of Orthopedic Surgery Director, Medical Sports Medicine Fellowship Program Boston Children's Hospital |
Right to Try Laws and Their Impacts on Research and Patient Access
December 11, 2020 | 12:30 - 2:00 PM ET
Webinar via Zoom (Register HERE)
In May 2018, the Right to Try Act was signed into law, creating a new pathway for patients with life-threatening conditions to access investigational drugs prior to FDA approval. Unlike its expanded access program, the FDA plays a limited role in right to try, which is negotiated between the patient and the drug developer. Prior to the federal law, more than half of states had passed their own versions of right to try. With two years of experiencing the law in action, two expert panelists will consider the effects of right-to-try. Early access to investigational drugs also raises numerous ethical questions, like whether individual patients should be able to bypass research, who bears liability for harms, whether informed consent is possible for an investigational drug, and if early access will delay research that could benefit all patients.
December 11, 2020 | 12:30 - 2:00 PM ET
Webinar via Zoom (Register HERE)
In May 2018, the Right to Try Act was signed into law, creating a new pathway for patients with life-threatening conditions to access investigational drugs prior to FDA approval. Unlike its expanded access program, the FDA plays a limited role in right to try, which is negotiated between the patient and the drug developer. Prior to the federal law, more than half of states had passed their own versions of right to try. With two years of experiencing the law in action, two expert panelists will consider the effects of right-to-try. Early access to investigational drugs also raises numerous ethical questions, like whether individual patients should be able to bypass research, who bears liability for harms, whether informed consent is possible for an investigational drug, and if early access will delay research that could benefit all patients.
|
EXPERTS:
|
MODERATOR:
|
George Q. Daley, MD, PhD
Dean of the Faculty of Medicine Harvard Medical School 
|
Insoo Hyun, PhD
Professor, Department for Bioethics Case Western University School of Medicine Faculty Member, Center for Bioethics, Harvard Medical School |
PAST EVENTS
Drug Shortages: Managing Prioritization & Improving the Supply Chain
October 9, 2020 | Webinar via Zoom
Drug shortages, when the supply of a drug is not adequate to meet current or near-term future demand, have become increasingly common in the U.S. These shortages occur for a variety of reasons, including disruptions to supply chains, manufacturing stoppages, and economic incentives. Drug shortages have real effects on patients and result in medication errors, delayed life-saving treatment, and worse patient outcomes. We will examine what policies could change the current situation and ensure the consistent supply of drugs. Shortages also raise important questions to consider about what clinicians should do during a shortage and how to make decisions about which patients to prioritize for treatment with a scarce resource.
October 9, 2020 | Webinar via Zoom
Drug shortages, when the supply of a drug is not adequate to meet current or near-term future demand, have become increasingly common in the U.S. These shortages occur for a variety of reasons, including disruptions to supply chains, manufacturing stoppages, and economic incentives. Drug shortages have real effects on patients and result in medication errors, delayed life-saving treatment, and worse patient outcomes. We will examine what policies could change the current situation and ensure the consistent supply of drugs. Shortages also raise important questions to consider about what clinicians should do during a shortage and how to make decisions about which patients to prioritize for treatment with a scarce resource.
|
EXPERTS:
Erin Fox, PharmD, BCPS, FASHP Senior Director, Drug Information and Support Services, University of Utah Yoram Unguru, MD, MS, MA Assistant Professor of Medicine Johns Hopkins University MODERATOR: Ameet Sarpatwari, PhD, JD Assistant Professor of Medicine Harvard Medical School and Brigham and Women's Hospital Assistant Director, PORTAL |
COVID-19, Public Health Ethics and Policy for Pandemics
September 11, 2020 | Webinar via Zoom
Since the SARS-CoV-2 pandemic began, scientific recommendations about the best way to reduce its impact have met wide-ranging resistance in the U.S. With two experts in infectious disease epidemiology and ethics, we will review how scientific evidence is collected in a rapidly changing public health environment, and how to translate that evidence into actionable recommendations. We will also discuss the sources of controversy that have arisen as the pandemic has evolved, including balancing individual and public health interests and how to manage different types of uncertainty.
September 11, 2020 | Webinar via Zoom
Since the SARS-CoV-2 pandemic began, scientific recommendations about the best way to reduce its impact have met wide-ranging resistance in the U.S. With two experts in infectious disease epidemiology and ethics, we will review how scientific evidence is collected in a rapidly changing public health environment, and how to translate that evidence into actionable recommendations. We will also discuss the sources of controversy that have arisen as the pandemic has evolved, including balancing individual and public health interests and how to manage different types of uncertainty.
|
EXPERTS:
Marc Lipsitch, DPhil Professor of Epidemiology Director, Center for Communicable Disease Dynamics Department of Epidemiology Harvard T.H. Chan School of Public Health Matthew Wynia, MD, MPH Director, Center for Bioethics and Humanities University of Colorado Anschutz Medical Campus MODERATOR: Leah Rand, PhD, MA Research Fellow, PORTAL |
|
