Protecting research subjects from a broken system
The current issue of The Hastings Center Report includes five articles about human research protection. One of them, "Eight Years after Jesse's Death, Are Human Research Subjects Any Safer?," asserts that
despite the press exposure and public outcry that followed [Jesse Gelsinger's 1999 death in a gene therapy clinical trial], no progress has been made in fixing the broken system of protections for human research subjects. These people…are still at serious risk of exploitation and harm.
Many things stand in the way of better protection, but perhaps the greatest obstacle is the lack of adequate federal oversight.
The article is especially significant because of its authors' expertise and experience. Adil E. Shamoo is a researcher in the University of Maryland's Department of Biochemistry & Molecular Biology and the founder and editor-in-chief of the journal Accountability in Research. Paul Gelsinger, the father of Jesse, has worked to improve human research protection since his son's death. Both have played lead roles with the human rights organization CIRCARE, Citizens for Responsible Care and Research.
The CIRCARE website includes a collection of documents about Jesse Gelsinger's death and the ensuing revelations about the researchers' egregious conflicts of interest, deliberate omissions in the consent form Jesse and his family signed, and scandalous lack of oversight by the FDA. In a 2001 essay titled "Jesse's Intent," Paul Gelsinger tells the story of his son's death and his own journey from complete trust in the researchers to sharp critic of a badly broken system.
One revealing episode takes place on the Gelsingers' back porch two months after Jesse's death. Paul Gelsinger asks head researcher Dr. James Wilson, who has come to Arizona with the results of Jesse's autopsy, whether he has any financial interests in the outcome of the study. Wilson replies that he is an unpaid consultant to Genovo, the biotech company that would profit from the research.
It was only later that Gelsinger learned that Wilson in fact owned a 30% share of Genovo. The following year, when it was sold to another biotech firm, Wilson received $13.5 million in stock.
The moral from my pov: Until these kinds of conflicts of interest are eliminated, research subjects will never be safe.
Previously on Biopolitical Times: