Healthy Skepticism Library item: 18263

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Publication type: Journal Article

Marwick C
FDA halts gene therapy trials after leukaemia case in France
BMJ 2003 Jan 23; 326:(7382):181
http://www.bmj.com/cgi/content/extract/326/7382/181/a

Abstract:

After the second occurrence of a leukaemia type illness in a patient in a gene therapy trial in France for X linked severe combined immune deficiency disorder (SCID), the US Food and Drug Administration has halted all trials that use retroviral vectors for inserting genes into bone marrow stem cells.

The move is described as a “precautionary measure” pending investigation. No evidence has been shown of leukaemia in any of the patients in the United States who have had this type of gene transfer, says the FDA.

Last September the French investigators, Dr Alain Fischer and Dr Marina Cavazzanna- Calvo at the Necker Hospital in Paris, reported that one of 11 patients with X linked SCID they were treating had developed T cell leukaemia about three years after receiving the gene transfer.

At that time the FDA suspended the three gene therapy trials of SCID patients in the United States that . . .