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Hundreds of gene therapy experiments failed

7 February 2000
By BioNews
Appeared in BioNews 44

Hundreds of failed genetic therapy experiments, including a number of deaths, came to light in the US this week. The reports flooded in to the US National Institutes of Health (NIH), after they asked researchers to provide information that might explain the death of Jesse Gelsinger during a gene therapy trial last September.

There have been 691 'serious adverse events' - serious deterioration or death - in US human gene therapy experiments over the past seven years. Only 39 of these had been reported previously, even though federal regulations require they are reported immediately.

Gene therapy is normally carried out on terminally ill patients, so it is unclear how many deaths have been caused by the technique itself. 'It is important to make these reports promptly so that appropriate measures can be taken by other researchers to safeguard the health of their patients', an NIH official said.

One US researcher fears poor results are being kept secret because of the financial damage they could cause the funding companies. 'Because of the commercialisation of this research there really is an incentive to keep secret anything that reflects badly on the progress of the work', said Professor Stuart Newman of the New York Medical College.

Representatives of the Food and Drug Administration (FDA) and the NIH told a senate hearing last week that they have no explanation for the late reports.

Earlier gene test deaths not reported
The Washington Post |  31 January 2000
Hundreds of gene therapy experiments failed
BBC news |  1 February 2000
Researchers suspected of hiding deaths in gene tests
The Guardian |  1 February 2000
Victim's Dad faults gene therapy team
The Washington Post |  3 February 2000
20 August 2007 - by Ailsa Stevens 
Last month a gene therapy trial for arthritis, carried out by US company Targeted Genetics, was halted when following the death of 36-year-old participant Jolee Mohr. Although the exact cause of her death is still unknown, the usually mild fungal infection found throughout Mrs Mohr's body...
11 February 2005 - by BioNews 
Two US institutions that ran a gene therapy trial in which a teenager died in 1999 agreed to pay more than $1 million in a civil settlement last week. The government had alleged that the researchers, based at the University of Pennsylvania and the Children's National Medical Center, had failed...
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