Bioethics Blogs

Questions about Deaths in Cancer Trials using Gene-Altered Cells

In the past month, the media has reported seven patient deaths of subjects enrolled in separate gene therapy clinical trials being conducted by Juno Therapeutics and by Ziopharm Oncology, Inc., both aimed at immunotherapy-based cancer treatments that have sparked widespread hope. Despite these deaths, the trials continue to move forward.

Media coverage of trials related to gene therapy has portrayed the clinical research rollercoaster.  Just this past week, The New York Times ran an unusually lengthy and high-profile series of articles in the Sunday paper about immunotherapy treatments for cancer, some involving genetic modification of immune cells. The articles describe the promising aspects of engineering one’s own immune system to fight cancer, including dramatic stories of tumors “melting away” and promises of complete remission.  

Yet commentary on the ethical implications of these events has been scant, and these events raise a number of concerns about what bioethicists call “therapeutic misconception” – vulnerable patients seeking enrollment in a clinical trial with the mistaken belief that the gene therapy is approved by the FDA to be safe and effective. The clinical trial deaths also highlight lingering questions about transparent reporting of adverse events to the FDA and appropriately navigating financial conflicts of interest.  Instead, numerous articles have focused on how these deaths impact the bottom line: corporate stock prices

The excitement has been building for some time. In June 2015, MIT Technology Review described Juno’s experimental T-cell immunotherapy for leukemia as “Biotech’s Coming Cancer Cure” and profiled the “miracle” recovery of 20-year old leukemia patient Milton Wright III.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.