Wired recently ran a long story headlined "The Fall and Rise of Gene Therapy." The title is displayed with images of two viruses, captioned:
This virus laid waste to James Wilson's career.
This virus could bring him redemption.
That's just not true. James Wilson laid waste to his own career as a pioneer of human gene therapy. (He did remain a professor at the University of Pennsylvania.) He did not, however, single-handedly destroy the prospects of gene therapy, as the article implies, and we should be properly skeptical as to whether he might single-handedly restore the field.
The first virus pictured was used in an experiment Wilson ran in 1999 that resulted in the death of 18-year-old Jesse Gelsinger, a subject in a gene-therapy clinical trial whose own disease was mild and well under control. His death was a tragedy no matter what the surrounding circumstances.
At first, Gelsinger's father, Paul Gelsinger, supported the scientists. Paul's support continued even after he learned that monkeys had died during the pre-clinical work; he was assured that adjustments had been made. (His personal account is here [pdf].) Then he started learning about the conflicts of interest involving Penn and, in particular, Wilson.
Most damningly, Wilson specifically told Paul Gelsinger that he was an "unpaid consultant" to Genovo, the company that at least partly funded the research and had exclusive rights to license the related patents. That was disingenuous at the very least. Wilson held 30% of Genovo's stock, and eventually cashed in, reportedly to the tune of $13.5 million.
There were more problems concerning conflicts of interest, many of them detailed in this FDA letter, and in other links here. Wilson was indeed punished, and his gene-therapy career did indeed go "into free fall" as the Wired story by Carl Zimmer notes. But it was his own doing.
There are curious omissions in the Wired account. The FDA's investigation of Jesse Gelsinger's death revealed that ten other gene-therapy subjects had previously died, in four different labs, and not been properly reported. Indeed, NIH discovered (paywall) that less than 4% of "serious adverse events" occurring in gene transfer trials were being reported as required.
A couple of years later, two children who had gene therapy in Paris for a fatal auto-immune disease ("boys in a bubble") developed leukemia, apparently when the retrovirus used lodged the new gene in an unfortunate place. That led to a temporary halt to all gene therapy trials.
In 2007, a woman died in a gene therapy trial, but investigators ruled that it was not directly caused by the treatment (see 1, 2). In recent years, however, reports of successful gene transfer treatments suggest that the techniques may eventually prove useful for a limited number of conditions.
Meanwhile, Wilson has been trying to rehabilitate his reputation, which is understandable. He has also been doing what seems to be good science, which is laudable. But we should focus on the systemic failures and the human lapses in judgment, not on a simplistic narrative of tragic failure and redemption through hard work.
You know who really deserves our thanks? Paul Gelsinger. He has worked tirelessly, mostly with Citizens for Responsible Care and Research, in an effort to ensure than no one else suffers as his family did. He quite rightly added his brief comments to the Wired story. In 2008, after Wilson had published an article (paywall) about informed consent (discussed here), Gelsinger summed up his position:
So, my son, doing the right thing, was killed by a system and people rife with conflicts of interest, and real justice has been found to be very lax. It's essentially business as usual. You may think that I am bitter, but I am not. My son gave me the best possible example on how to be. The system showed me what everything is really all about. Hopefully, given enough time they'll fix this, but I'm not holding my breath. Anyone considering joining a clinical trial needs to be aware that they are dealing with a system that is seriously flawed.
Previously on Biopolitical Times:
Posted in Bioethics, Biotech & Pharma, Medical Gene Transfer, Pete Shanks's Blog Posts, US Federal
CommentsAdd a Comment
Comment by Robert Dingwall, Sep 2nd, 2013 12:19pm
There was a lot more to this story about the failures of the Feds and the way Wilson took the fall for them. I dug out quite a lot of stuff online but never got round to writing it up because it was too hard to fill in the rest from offshore. However, it is apparent that Wilson could reasonably have thought he had clearance to proceed although the Feds silence was because of their own inertia rather than active approval. I suspect that this may have a lot to do with the bounce back.
Comment by Josie, Aug 27th, 2013 12:34am
Well, you only get 15 years for first-degree murder and half off for good behaviour. I think therefore that James Wilson has well and truly done his time since 1999 having to endure the guilt and the near ruination of his reputation and career due to people like yourself who cannot accept that clinical trials are risky and sometimes unfortunately people die. I am sure that not a day goes by where he doesn't think of the tragedy of Jessie's death, and his part in it, and I'm sure that this is what has driven him to work tirelessly as some sort of penance to make sure the chances of this happening again are much more remote. It might be worth noting that children and adults with fatal diseases are now cured thanks to the vectors James Wilson has gone on to develop. Jessie undertook a clinical trial, with unknown outcomes, in an effort to help those with his disease and hopefully provide a cure in the future. His wish will come true, except for millions of people with all sorts of diseases, not just the one that Jessie suffered from.