Thought Experiments on a History of Gene Transfer Experiments
Imagine you are the editor of a journal devoted to the field of financial counseling. Would you publish an article on “The History and Promise of Investment Advising” written by Bernie Madoff?
Now imagine you are commissioning an article for a biology news journal on “The History and Promise of Stem Cell Research.” Would Hwang Woo-Suk be on your list of candidate authors?
These are thought experiments. Not so the feature article in the October 1 issue of Genetic Engineering & Biotechnology News titled “The History and Promise of Gene Therapy.” Its author is James M. Wilson, lead researcher in the infamous 1999 real-life experiment in which 18-year-old Jesse Gelsinger died.
That tragedy, which along with its aftermath was a key event in the “history of gene therapy,” is entirely unmentioned in the article. Wilson does write of “many failed clinical trials” and of “enthusiasm and expectation far in excess of the reality of the science.” He seems to attribute these to an “erosion of support for gene therapy” and “a variety of political and regulatory barriers that…surfaced.” He does not acknowledge either the death of Jesse Gelsinger or his own role in it, which was far from peripheral.
A few of the details: After the teen’s death, an FDA investigation, Congressional hearings, and media reports revealed numerous serious misdeeds by Wilson and his team. They did not tell Gelsinger or his family that two monkeys had died in a pre-clinical study of the procedure, or that previous human volunteers in the same trial had suffered serious adverse reactions, or that Wilson himself owned a 30% share of the biotech company that stood to make many millions of dollars if the trial was successful.
And the deceptions didn’t end after Jesse’s death. Two months later, Wilson traveled to Arizona with the results of Jesse Gelsinger’s autopsy. Gelsinger's father Paul, who initially supported the researchers, asked Wilson whether he had any financial interests in the outcome of the study. Wilson denied it. (For more, see articles collected by Citizens for Responsible Care in Research; an essay by Paul Gelsinger [PDF]; an article by Osagie Obasogie.)
Wilson's history also fails to mention that the NIH and FDA investigations revealed several other deaths in gene transfer trials across the country. Indeed, one set of experiments by a Harvard Medical School researcher had been suspended after three of the first six patients died, though this was not immediately reported, as it should have been. After the Gelsinger tragedy hit the headlines, over 650 tardy reports of "serious adverse events" were filed.
Wilson has been punished. He was barred from doing research involving human subjects for several years. A 2005 legal settlement with the US Department of Justice levied a $517,000 fine on his university, and imposed other restrictions on his activities.
In recent years, Wilson has again emerged as a leader in the field of gene transfer research. Though no one would be likely to refer to him today as the "Michael Jordan of gene therapy," as did a 1992 University of Pennsylvania press release, he is the editor-in-chief of the journal Human Gene Therapy and is often quoted in popular scientific media (in addition to running a lab at UPenn and publishing widely in professional journals).
I believe in the possibility of rehabilitation. But doesn’t rehabilitation require acknowledgment? In 2009, as part of his DOJ settlement, Wilson published a 6,000-word article about the lessons he learned. He characterized this as an apology, but Paul Gelsinger saw it differently. “I don't see it as an apology at all,” he said at the time. “There's never been an acknowledgment of wrongdoing."
No one would suggest that Wilson has to apologize for Jesse Gelsinger’s death every time he turns on his laptop. And we certainly need talented scientists to be productive. But what does Wilson’s current article say about him as a person and a scientist? What does it indicate about the editorial integrity of Genetic Engineering & Biotechnology News? What does it bode for the future of gene therapy?
Previously on Biopolitical Times: