Document Type

Article

Publication Title

American Journal of Law & Medicine

Publication Date

2010

Abstract

Ten years ago, Jesse Gelsinger died while participating in a human gene therapy trial at the University of Pennsylvania (“Penn”). His death came to signify the corrosive influence of financial interests in human subjects research. After Jesse's death, the media reported that one researcher. Dr. James Wilson, held shares in a biotech company, Genovo, which stood to gain from the research's outcome — shares that The Wall Street Journal later valued at $13.5 million, although Wilson maintains he did not make nearly this much. At the time Penn authorized Wilson's deal, internal Penn documents implicitly valued Wilson's stake in Genovo at approximately $28.5 to $33 million. In 2009, the Institute of Medicine joined a growing chorus of voices that called for significant reforms to the rules governing disclosure of financial conflicts of interest. The IOM and other groups would presumptively bar nearly all equity stakes by researchers like Wilson. Although the IOM's view represents the dominant narrative about financial conflicts of interest, it is not the only one. One influential group urges that financial conflicts can never be removed from medical research and, indeed, should not be.

This Essay evaluates these polar positions by examining Jesse's participation in human research and his death. Drawing on new evidence from the documents collected in the Gelsingers' lawsuit, this Essay asks specifically whether new and better restrictions on financial conflicts of interest would have made a difference in Jesse's case and concludes that more robust restrictions would not have mattered. This Essay argues that rather than attempting to expunge financial interests from research, those interests should trigger significant, ongoing review of the affected clinical trials, much like the post-approval monitoring now used randomly by leading research institutions. Indeed, had Wilson's outsized financial stake triggered mandatory monitoring, people inside Penn likely would have stumbled upon the string of questionable decisions in Jesse's trial, including departures from the research protocol, long before those mistakes cascaded, culminating in Jesse's death.

This Essay describes the research trial Jesse participated in and the lawsuits spawned by his death, and recaps the cavalcade of errors that the FDA says plagued the trial long before and up to Jesse's death, errors now largely acknowledged by Wilson. Next, this Essay reviews what the researchers told Jesse about the trial's risks, the results of prior animal studies, and the basic protections he would receive as a participant, and contrasts those disclosures with the frank disclosures approved by regulators at the trial's start. This Essay then follows the money, showing the nature and extent of Wilson's financial conflict of interest, and demonstrates that a lot of good people inside Penn sounded alarm bells about Wilson's hefty stake, to no avail. Next, this Essay sketches the precautions suggested by Penn faculty to reduce risks to subjects participating in Wilson's research, such as creating a firewall between Wilson and crucial decisions in Jesse's trial. This Essay then contrasts those proposed precautions with what actually transpired in Jesse's trial, noting the integral role Wilson played in many key decisions. This Essay then evaluates the competing narratives about financial conflicts of interest through the lens of Jesse's trial. Finally, this Essay concludes by examining greater oversight of human trials and monitoring for human safety.

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