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Tuesday, 1 February, 2000, 16:34 GMT
Hundreds of gene therapy experiments failed
Gene therapy may one day provide treatments for cancers
Gene therapy may one day provide treatments for cancers
Hundreds of failed gene therapy experiments, including a number of deaths, have been revealed in the US.

The US National Institutes of Health (NIH) has confirmed that only 39 of the 691 "serious adverse events" now logged had been reported to them "immediately", as required by federal regulations.

The late reports have flooded in since the death of a teenager undergoing gene therapy last year. This prompted the NIH to send stern letters to researchers reminding them of their duty to report problems.

Financial damage

One prominent US researcher said he was worried that poor results were being kept secret because of the financial damage they could cause to the funding companies.

Professor Stuart Newman, at the New York Medical College, said: "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."

Gene therapy is an experimental treatment for serious diseases including cancer. DNA is inserted into the patient's cell, usually through the action of an infectious virus. Despite much research effort, no successful gene therapy treatment has yet been developed.

Fevers and paralysis

The newly-revealed failures, detailed in the Washington Post newspaper, show that many patients suffered fevers, clotting abnormalities and serious drops in blood pressure.

Problems were also caused by the medical procedures used to deliver the genetic material. Needle damage in patients being treated for brain tumours has apparently led to partial paralysis and speech impairment.

In one study taking place in a Boston hospital, three of the six patients involved died. But chief researcher Richard Junghans, of Harvard Medical School, blames the problems on tragic coincidences mostly unrelated to the gene therapy, according to the Washington Post.

Rule violations

The NIH committee is supposed to help decide the cause of any deaths or illnesses "so that appropriate measures can be taken by other researchers to safeguard the health of other patients".

Because so many reports had not been properly filed, it is not now clear whether 18-year-old Jesse Gelsinger, who died in September 1999, really was the first person to lose his life as a result of gene therapy or merely the first the federal government knew about.

Gelsinger was treated and died at the University of Pennsylvania and on 21 January the Food and Drug Administration (FDA) shut down all its gene therapy experiments because of numerous violations of federal research rules.

Researchers are supposed to report problems to both the NIH and the FDA but the FDA keeps most information secret, whereas the NIH makes everything public.

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