Officials have given the go-ahead for a gene therapy trial - set up by US Company Targeted Genetics - to resume despite the death of 36-year-old participant Jolee Mohr in July. After reviewing the evidence a committee of experts set up by the US National Institutes of Health (NIH) ruled that the gene therapy did not contribute to the participant's death; an outcome which the company has taken as evidence that the therapy is safe.
'I think it's a vindication for the product, for the company and really for gene therapy', said H. Stewart Parker, chief executive of Targeted Genetics. But Mrs Mohr's husband Robb is not so strongly convinced. 'I think it's very reckless', he said in an interview. 'They still don't know what caused her death. They still haven't reported on her death'.
In September a committee assembled to investigate Mrs Mohr's death ruled that, although the primary cause of death was likely to be a common fungal infection, a link to the gene therapy could not be ruled out. This latest ruling comes in light of new evidence presented by Targeted Genetics since September, which suggests that the level of immune system suppression caused by the gene therapy was trivial compared to that caused by 'Humira', a common arthritis drug that Mrs Mohr had been taking.
At the time of the September meeting, one judgement on which the whole committee agreed was that the way in which Mrs Mohr was recruited on to the trial, although not strictly unlawful, may not have furnished the proper conditions for informed decision making. As a result the company have said that the patient consent form for the trial has been revised to reflect Mrs Mohr's death, and that new safeguards have been put in place, such as not allowing patients showing signs of infections to continue on the trial. They have also indicated that when the trial resumes, the 35 out of 127 patients yet to receive their second gene therapy injection will be informed of the death.
The death of Mrs Mohr had threatened to put another black mark against gene therapy - a field which shows much promise, despite having had some major setbacks during its relatively short history. Although on this occasion it has been ruled that the gene therapy was not to blame, questions remain over whether early-stage gene therapy trials should be carried out on people whose conditions, like Mrs Mohr's, are not life-threatening.
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Gene therapy trial to restart
Targeted Genetics to resume gene therapy study