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Gene Therapy Deaths and the Future of Gene Therapy
After the first case of gene therapy attempted in 1990, gene therapy was considered to be a promising area of research for human health care. But after almost a decade, in the year 1999, a solitary case of death of an 18-years old patient (Jesse Gelsinger) at the University of Pannsylvanias Institute of Human Gene Therapy, set in motion a fresh debate on the desirability of conducting clinical trials on human subjects.

The patient suffered with an heritable disease of liver and a heavy dose of gene for ornithine-transcarbamylase or OTC (needed for removing excess of ammonia from blood) carried by a vector (crippled adenovirus), was introduced.

The patient died on 17th September, 1999, four days after the genetically altered virus was injected into his liver. The death was attributed to massive immuno-response caused by adenovirus and resulted in a major blow to the field of gene therapy in USA and elsewhere. All clinical trials at University of Pennsylvanias Institute of Human Gene Therapy were stopped and an investigation was ordered. Several other deaths of patients undergoing gene therapy were not reported and were sometimes attributed to causes other than gene therapy. FDA (Food and Drug Administration) of USA was therefore scrutinizing all gene therapy programmes across USA. As a consequence of the above, the use of adenovirus that was once considered to be the most efficient vector (capable of infecting both dividing and non-dividing cells and capable of expressing the gene within 24 hours, as against 3-6 weeks needed with other vectors), has been curtailed in several laboratories.