Bioethics and the risk regulation of ‘frontier research’: The case of gene therapy

Risk and regulation of a ‘frontier science’ In July 2007 Jolee Mohr, a 36-year-old woman, died in the course of a clinical trial designed to test the safety of a new genetic therapy for rheumatoid arthritis. Mohr was injected with copies of a gene responsible for the production of an enzyme that could help alleviate the severe inflammation of the joints that is characteristic of the disease. While not immediately life-threatening, rheumatoid arthritis is a disabling autoimmune disorder that can only be managed with the help of a burdensome medication regime, and Mohr had been suffering from it for more than fifteen years. Two days after receiving a second dose of the treatment, Mohr was admitted to hospital with flu-like symptoms. Three weeks later she died after massive organ failure. News of Mohr's death shocked the gene therapy community. Many saw in it further proof, if further proof was needed, of the inherent hazards of an area of medical research long associated with clinical failure. More than twenty years had passed since the first clinical study for human gene transplantation was authorised in the United States, yet the field still retained its reputation as a sort of ‘frontier science’, an area of highly experimental research where potential rewards came too often tinged with unacceptable levels of risk and a degree of recklessness.