Justice and Safety in Testing of New Therapeutics

Abstract

This case study examines the ethics and social tensions involved in developing and producing new drugs. Using the opioid epidemic and HIV/AIDS pandemic as historical reference points, it traces the manner in which scientific discoveries to alleviate suffering are possible to commercialize or exploit. The study recounts the manner in which Candace Pert's finding on opioid receptors led to life-saving therapies as well as an addiction epidemic that was induced by aggressive promotion of the drugs by drug firms. It also refers to her later work on Peptide T, an untested HIV medication that gained unofficial circulation among desperate patients. The case analyzes how patient activism, embodied in ACT UP in the AIDS epidemic, was able to pressure mainstream clinical trial procedures, calling for faster access to untested drugs. This emphasis on speed and deregulation, however, is challenged regarding safety, equity, and exploitation. The study criticizes the war between patient rights to experimental therapy and the public interest of stringent validation, cautioning against deregulation as a solution to empower profit interests and to expose vulnerable patients to risk. Finally, it invites students to consider how to find balance among compassionate use, individualized medicine, and regulatory oversight to increase innovation, and universal health equity.