Lexington, VA ē Monday, September 07, 2009September 17 marks the ten year anniversary of the death of Jesse Gelsinger. Just three months past his 18th birthday, Gelsinger†was the first person to die in a human gene therapy trial.
But the public still knows almost nothing about the details surrounding his death and the human research trial in which he participated. The lawsuit filed by Jesse's family against the researchers quickly settled, as did the US Government's civil false claims act suit against the researchers. The media maelstrom that followed Gelsinger's death and exposed this once promising new medical treatment to scrutiny has long since quieted.
Gelsinger's story is just one of the cases revisited in a new collection co-edited by Washington and Lee Law professor Robin Fretwell Wilson. Health Law and Bioethics: Cases in Context (Aspen) delves into the human side of the landmark cases in this field, conveying the back story and creating context to deepen understanding of the law and policy implications of each case.
"Court records are sterile recitations of a body of facts and how those facts should matter to what is usually an arcane legal question," says Wilson. "Overlooked frequently is the human drama, how the cases came to be and the crucial litigation decisions that affected the outcome. We hope this book will be a companion to many case books and raise questions that were missed."
The book, co-edited by Wilson, Sandra H. Johnson, Joan H. Krause, and Richard Saver, contains analysis of thirteen cases involving medical and legal controversies, including the right-to-die cases of Karen Ann Quinlan and Terry Schiavo and a parental rights dispute involving a surrogate mother. Wilson's own contribution to the volume, "Estate of Gelsinger v. Trustees of University of Pennsylvania: Money, Prestige, and Conflicts of Interest in Human Subjects Research," uncovers the financial and personal conflicts of interest that may have contributed to Jesse Gelsinger's death.
"The Gelsinger case has become the poster-child for a financial conflict of interest that went awry," says Wilson. "But before this book was written, we really knew very little about what actually occurred."
Gelsinger was born with a rare genetic disease, often fatal, that affected the ability of his liver to metabolize ammonia. Multiple medications and a restrictive diet kept him alive. When he learned of the clinical trial, he was eager to volunteer so that researchers in this early trial could learn how to fix this condition, if not for him, then for others in the future. On September 13, 1999, Gelsinger was injected with adenoviruses carrying a corrected gene scientists hope would correct his liver function. He died four days later.
A Food and Drug Administration (FDA) investigation concluded that the researchers involved in the trial broke several rules of conduct, including using Gelsinger in the study when tests showed ammonia levels in his body exceeded those permitted by the study protocol and failing to disclose the previous results of the gene therapy in prior patients, which included serious side effects, and for failing to disclose the death of non-human subjects. Government regulators also raised questions raised regarding a conflict of interest related to the lead researcher's financial stake in the trial's success. But most of the details of the case never became public.
"Recent studies have shown that the problematic conflicts that existed in the Gelsinger case are fairly common among researchers and the institutions that support them," notes Wilson. "Hopefully, a better understanding of what happened here will be instructive going forward for researches and patients involved in human subject research."
Health Law and Bioethics: Cases in Context is available now from Aspen Publishers.
A specialist in family law and health law, Professor Wilson's research and teaching interests also include insurance and biomedical ethics. She is the editor of three other volumes: Same-Sex Marriage and Religious Liberty: Emerging Conflicts; Reconceiving the Family: Critical Reflections on the American Law Institute's Principles of the Law of Family Dissolution; and the Handbook of Children, Culture & Violence. In 2007, she earned one of 10 "citizen lawmaker" awards presented by Del. Rob Bell, R-Albemarle County, for her research that led to a new Virginia state law prohibiting unauthorized pelvic exams by medical students. In 2009, she was elected to the American Law Institute, the most prestigious law reform body in the U.S.††† ††††