Organizers: Alison Bateman-House (NYU School of Medicine), Melanie Brickman Stynes (The New York Academy of Sciences), Arthur Caplan (NYU School of Medicine), Brooke Grindlinger (The New York Academy of Sciences), and Erick Tatro (The New York Academy of Sciences)Presented by the NYU School of Medicine and the New York Academy of Sciences
Reported by Hallie Kapner | Posted January 25, 2016
On October 28–29, 2015, the New York Academy of Sciences and NYU School of Medicine convened a multidisciplinary conference on pre-approval access to medicines outside a clinical trial, or what is often referred to as compassionate use. The process by which critically ill patients may request access to experimental therapies prior to regulatory approval poses complex ethical, legal, and social challenges that often leave patient advocacy groups, physicians, pharmaceutical companies, regulators, and patients at odds in the struggle to determine how far an individual can go to try to save his or her own life, and at what—and whose—cost.
The 2-day conference consisted of panel discussions designed to probe different aspects of compassionate use. Stakeholders came together to put the system under the microscope, examining how heightened public awareness of compassionate use, advances in drug development, the advent of social media, and the costliness of safely bringing a drug to market affect decisions about whether—and how—to provide experimental therapies on a compassionate-use basis.
Through spirited debates and networking opportunities, conference attendees worked to lay the foundation for better, more collaborative decision making regarding compassionate use policies and programs, and to answer the title question—Pre-Approval Access: Can Compassion, Business, and Medicine Coexist?
Use the tabs above to find a meeting report and multimedia from this event.
Panel discussions moderated by:
Alison Bateman-House, MA, MPH, PhD (NYU School of Medicine)
Arthur Caplan, PhD (NYU School of Medicine)
Nancy Neveloff Dubler, LLB (New York City Health and Hospitals Corporation; NYU School of Medicine)
Brooke Gladstone (WNYC Studios, On the Media)
Fred Guterl (Scientific American)
The portion of the eBriefing that pertains to Matthew Hepburn's remarks in Session 7 is a work of the U.S. Government, and the copyright protection under 17 U.S.C § 105 is not available for any work of the U.S. Government.
This symposium was made possible with support from
How to cite this eBriefing
The New York Academy of Sciences. Pre-Approval Access: Can Compassion, Business, and Medicine Coexist? Academy eBriefings. 2016. Available at: www.nyas.org/CompassionateUse-eB