Jesse Gelsinger: Ten Years Later

Posted by Osagie Obasogie September 25, 2009
Biopolitical Times
Jesse Gelsinger
Last Thursday marked the ten-year anniversary of Jesse Gelsinger’s death. The 18-year-old died while participating in a gene therapy clinical trial at the University of Pennsylvania. News of his death in September 1999 and the shady circumstances surrounding it rocked the medical research world. These circumstances included a failure to disclose the deaths of monkeys in pre-clinical trials, adverse reactions among humans in prior tests, and financial ties between a researcher and a private biotech company, in which the main investigator stood to make millions if the trial was successful.  

In the wake of this tragedy, investigative journalists and federal hearings dug up mounds of evidence concerning the inadequacy of human research protections and, in particular, the many failings that led to Jesse’s death. While some of the findings from the federal investigation were made public, several key documents remain hidden from public view to this very day. Last week in a Philadelphia Inquirer op-ed, Jesse’s father renewed his plea for their release:
I thought the lawsuits brought by me and the government would change research practices and the rules governing research. When I settled, real reform seemed likely. The Senate had held hearings, the FDA was investigating whether mistakes were made in the trial, and influential medical bodies such as the Association of American Medical Colleges had begun to examine disclosure practices and financial ties.

But, sadly, we have not yet learned enough from Jesse's death. The shroud of secrecy that envelops legal settlements has helped hinder reform. No one has publicly accounted for the mistakes that led to Jesse's death.

We don't know whether the FDA was misled or dropped the ball. We don't know whether the researchers' claims of efficacy had any basis in fact or were just wishful thinking. We don't know why Penn approved the deal despite warnings. And we don't know whether the researchers' decision to administer the virus to Jesse was reasonable or reckless.

Ten years ago today, my son died in a science experiment. A complete record of what the researchers and FDA regulators knew is the best precaution against future tragedies like Jesse's death.

I am asking that the University of Pennsylvania and the FDA finally do the right thing and release their records. If they did nothing wrong, let us see the proof. If they made a mistake, let us all learn from it and do better in the future. We owe it to Jesse to make his life and death mean something.