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Regulating gene therapy

7 February 2000
By Juliet Tizzard
Director, Progress Educational Trust
Appeared in BioNews 44
News this week from the US that failed gene therapy trials are not being reported as required, has prompted concerns about the regulatory structures surrounding genetic therapy. Reporters at the Washington Post came across reports of hundreds of failed gene therapy experiments which had not previously been sent to the National Institutes of Health (NIH). Until now, it had been assumed that Jesse Gelsinger's death last year was not a common occurrence in gene therapy trials. But the reporting of 691 serious adverse events during gene therapy trails has raised concerns that such complications are not so rare after all.

The regulation of gene therapy trials in the United States seems to be a complicated affair - particularly when it comes to reporting outcomes. Some teams have claimed ignorance of the rules, which involve reporting results both to the NIH and the Food and Drug Administration (FDA). Others have suggested that pressures from commercial sponsors have made researchers reluctant to own up to deaths and serious side-effects.

The main problem with the failure to report outcomes - both good and bad - is that it makes those responsible look like they have something to hide - even though they may all have nothing at all to hide. Many researchers have suggested that the deaths during or after gene therapy may be a result of the disease for which the patient is being treated, rather than a result of the therapy itself. But even if the deaths were caused by the experimental therapy, they have been unavoidable, given that gene therapy is still very much in its infancy. After all, countless new medical technologies or surgical procedures have taken time to perfect and the risk of death may be very high in the initial stages.

It's often tempting, when problems are uncovered in science, to demand new rules and regulations. But, in this instance, the priority seems to be the enforcement of existing regulations. Another lesson might be that openness is essential - not just for the sake of public confidence in genetic research, but in order that scientists might learn from the mistakes - and the successes - of their peers.

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