Health Policy and Bioethics Consortia
The Health Policy and Bioethics Consortia is a monthly series that convenes two international experts from different fields or vantage points to discuss how biomedical innovation and health care delivery are affected by various ethical norms, laws, and regulations.
They are organized by the Harvard Medical School Center for Bioethics and the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women's Hospital, in collaboration with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Support provided by the Oswald DeN. Cammann Fund at Harvard University.
Investigational Drugs and Stem Cell Treatments:
Legal and Ethical Considerations of Right to Try Laws
Friday, December 11, 2020, at 12:30 p.m. ET
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Access to investigational drugs has been a controversial topic during the COVID19 pandemic: what is the level of evidence required? How do we evaluate individual access requests, particularly from public figures such as outgoing Presidents? How does providing access change the ability to acquire fundamental information about these products? 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 products prior to FDA approval. Prior to the federal law, more than half of states had passed their own versions of right to try. Two expert panelists will consider the scientific, legal, and ethical issues relating to access to investigational treatments and how Right to Try laws change the landscape for the future.
Discussants:
George Q. Daley, MD, PhD
Dean of the Faculty of Medicine
Harvard Medical School
Alison Bateman-House, MPH, PhD
Assistant Professor
Department of Population Health
NYU Grossman School of Medicine
Insoo Hyun, PhD
Director of Research Ethics
Center for Bioethics
Harvard Medical School
Professor of Bioethics
Case Western Reserve University School of Medicine
PAST EVENTS
The NFL, Youth Sport, and Concussions
Friday, November 13, 2020 at 12:30 p.m. ET
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.
Discussants:
Kathleen Bachynski, PhD, MPH
Assistant Professor, Muhlenberg College
Grant Iverson, PhD
Professor, Department of Physical Medicine and Rehabilitation
Harvard Medical School
Director, Sports Concussion Program
MassGeneral Hospital for Children
Moderator:
Cynthia Stein, MD, MPH
Attending Physician, Sports Medicine Division
Department of Orthopedic Surgery
Director
Medical Sports Medicine Fellowship Program
Investigational Drugs and Stem Cell Treatments:
Legal and Ethical Considerations of Right to Try Laws
Friday, December 11, 2020
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.
Discussants:
Alison Bateman-House, MPH, PhD
Department of Population Health at NYU Grossman School of Medicine
George Daley, MD, PhD
Dean of the Faculty of Medicine
Harvard Medical School
Moderator:
Insoo Hyun, PhD
Professor, Department for Bioethics
Case Western University School of Medicine
Director of Research Ethics
Senior Lecturer on Global Health and Social Medicine, Part-time
Harvard Medical School