ngin - Norfolk Genetic Information Network
 
Date:  14 December 2000

US  GENE  THERAPY  RULES  RELAXED

Here's another one we missed earlier! The US National Institutes of Health (NIH) advisory committee that oversees human gene therapy experiments endorsed a plan  at the end of June that would allow researchers to wait as long as a year before reporting certain serious illnesses or deaths among volunteers in gene therapy experiments - a change from the current rules that demand "immediate" reporting of all such "adverse events."

This move came less than a year after the death of Jesse Gelsinger and the subsequent revelations that "gene therapy researchers had in recent years failed to report promptly, as required, more than 650 serious adverse events among volunteers in gene therapy experiments."

According to the Washington Post:

"[The] vote by the RAC to relax its reporting requirements was its first definitive action on the controversial topic since three events last fall pushed the panel to review its rules.

First, the RAC had begun to receive adverse-event reports from pharmaceutical and biotechnology company researchers stamped "confidential," a practice that committee members found worrisome and possibly illegal.

Then 18-year-old Jesse Gelsinger died. The Penn study was later cited by the FDA as being in violation of several federal rules; the cited infractions included inadequate reporting of the serious side effects suffered by previous volunteers in the study.

Third, as the NIH looked into Gelsinger's death, it became clear that hundreds of adverse events had not been reported to the NIH and the RAC as required."

Massive industry lobbying followed claiming the reporting system was too burdensome and, in effect, that a lot of the patients would have got sick anyway. So a result, the rules have now been relaxed!

Adjusting the rules to accommodate worst practice is known as "harmonisation"! A bit like what Aventis and much of US agribiz want the EPA to do with Starlink - approve it for human consumption, at least for as long as it takes to flow through the food chain - about 4 years, and
then there won't be a problem.

NIH's mistake, of course, was to have any rules in the first place - they should have modelled themselves on the FDA who have been all too happy to keep corporate secrets and to allow the biotech companies to provide them with pretty much whatever data (if any!) they choose, and
who at one time had Henry I Miller - one of the world's most rabid deregulators - in charge of their Office of Biotechnology.

Alan Milstein, the Philadelphia lawyer representing Paul Gelsinger, whose son Jesse died in September in the University of Pennsylvania gene therapy experiment, commented on the rule adjustment,"The gene therapy community in the past has shown that it was not willing to comply with rules which were in place to protect patients' and subjects' rights. It's a very dangerous step to respond to that deficiency by eliminating the very requirement which gene therapy investigators in the past refused or neglected to comply with."

However, W. French Anderson, the University of Southern California researcher who has been leading the charge on both somatic and human germline gene therapy welcomed the changes... well, he would, wouldn't he?

The article is : Reporting Rules for Gene Therapy Experiments to be Loosened - Washington Post, June 30, 2000
www.washingtonpost.com/wp-dyn/articles/A23297-2000Jun29.html

For more on the problems with gene therapy see:
GENE  THERAPY  WITHOUT  THE  CAVEATS
http://members.tripod.com/~ngin/178.htm
 
 

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