April
4

Research Ethics and Policy Series: Gregg Gonsalves, PhD

12:00pm - 1:00pm • Hybrid: Jordan 516 EW Seminar Rm (Jordan Medical Education Center, 3400 Civic Center Blvd)), and virtual via Zoom.

2022-04-04 12:00:00 2022-04-04 13:00:00 America/New_York Research Ethics and Policy Series: Gregg Gonsalves, PhD And You May Ask Yourself, How Did We Get Here? AIDS Activism and the Quest for Access and Answers on New Drugs   Gregg Gonsalves, PhD Associate Professor of Epidemiology (Microbial Diseases) Affiliated Faculty, Program in Addiction Medicine Associate (Adjunct) Professor of Law, Yale Law School Co-Director, Global Health Justice Partnership Co-Director, Collaboration for Research Integrity and Transparency HYBRID! Registration via Zoom is required for BOTH in-person and virtual participation. LOCATION: Jordan 516 EW Seminar Rm Jordan Medical Education Center, 3400 Civic Center Blvd Abstract: AIDS activists in the 1980s descended on the FDA in protest claiming the agency was killing them by delaying approval of promising AIDS drugs. The truth turned out to be more complicated as the first generation of antiretroviral drugs was far from promising leading to years of uncertainty about their clinical effects. Activists pioneered new mechanisms to ensure access to new drugs for AIDS, but also proposals to garner the necessary evidence to guide their optimal use. By the early 1990s, activists were pushing for the FDA to get tougher on companies and confirmatory studies under accelerated approval, but Pandora’s box had already been opened leading to decades of faster and faster drug approvals with less and less evidence about their effectiveness. Information: Mary Pham, Mary.Pham@pennmedicine.upenn.edu  Hybrid: Jordan 516 EW Seminar Rm (Jordan Medical Education Center, 3400 Civic Center Blvd)), and virtual via Zoom. Penn Medical Ethics

And You May Ask Yourself,
How Did We Get Here?
AIDS Activism and the Quest for Access and Answers on New Drugs

 

Gregg Gonsalves, PhD
Associate Professor of Epidemiology (Microbial Diseases)
Affiliated Faculty, Program in Addiction Medicine
Associate (Adjunct) Professor of Law, Yale Law School
Co-Director, Global Health Justice Partnership
Co-Director, Collaboration for Research Integrity and Transparency

HYBRID! Registration via Zoom is required for BOTH in-person and virtual participation.

LOCATION: Jordan 516 EW Seminar Rm
Jordan Medical Education Center, 3400 Civic Center Blvd

Abstract: AIDS activists in the 1980s descended on the FDA in protest claiming the agency was killing them by delaying approval of promising AIDS drugs. The truth turned out to be more complicated as the first generation of antiretroviral drugs was far from promising leading to years of uncertainty about their clinical effects. Activists pioneered new mechanisms to ensure access to new drugs for AIDS, but also proposals to garner the necessary evidence to guide their optimal use. By the early 1990s, activists were pushing for the FDA to get tougher on companies and confirmatory studies under accelerated approval, but Pandora’s box had already been opened leading to decades of faster and faster drug approvals with less and less evidence about their effectiveness.

Information: Mary Pham, Mary.Pham@pennmedicine.upenn.edu 

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