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To: scaram(o)uche who wrote (485)1/22/2000 8:49:00 PM
From: Jim Oravetz  Read Replies (2) | Respond to of 673
 
FDA halts work at gene-therapy lab
Investigation into teen's death uncovers research violations
By Rick Weiss and Deborah Nelson WASHINGTON POST

Jan. 22 The federal government Friday halted all human gene therapy experiments involving a prominent researcher at the University of Pennsylvania, saying an investigation into the September death of a teenager there found the school's prestigious program in serious disarray.

...18-year-old Jesse Gelsinger into the study even though he was not healthy enough to qualify. Gelsinger died from the treatment Sept. 17, in what is believed to be the first death caused directly by gene therapy....

...Penn's institute is one of the largest academic gene therapy centers in the world, with an annual budget of about $25 million and links with private biotechnology companies. Wilson, who is a key investigator in all seven gene therapy studies suspended by the FDA, has come under increased scrutiny in the months since Gelsinger's death, in part because of revelations that he had a potentially large financial stake in the outcome of the Gelsinger study.....

"If Gelsinger was never told that four people before him had Grade 3 [serious] toxicities and that monkeys had been killed by this kind of treatment, then you have to ask, did he really give informed consent or did he just give consent?" asked Leon Rosenberg, a geneticist at Princeton University who pioneered research on Gelsinger's disease.

washingtonpost.com

Sounds like the people at Penn are/were running a pretty low quality operation their. Some serious lack of both ethical and professional conduct. They deserve to be shut down.

Jim



To: scaram(o)uche who wrote (485)1/22/2000 8:54:00 PM
From: Torben Noerup Nielsen  Read Replies (1) | Respond to of 673
 
Richard,

NABI deserves at least honorable mention. Just take a look at the chart for this last week. It's enough that I no longer believe it was just because of the nicotine vaccine story that ran although that may have caused some people to take a closer look.

In my opinion, Nic-VAX is a fantastic ace in the hole if it works. And it's known to work on monkeys so it ought to work just fine on humans.

But the real potential here lies in their Staphyloccus Aureus vaccine. Yes, other groups are working on that too, but NABI has a patent that allows only them to make a trivalent vaccine. Everyone else has to make do with the bivalent one. And I think this is a major plus since the additional strain adds coverage about 15% of coverage. Given the rise of nosocomial infections, vaccination against S. Aureus might become part of standard preparation for non-emergency surgery. Or for any hospitalization for that matter. Consider women who're giving birth; there are a lot of them and most go into a hospital or clinic. As far as I know, it's safe to give them vaccines once they enter the 3rd trimester and it would seem a reasonable precaution if there were a safe vaccine. The notion of pregnant women being a group that's particularly at risk for nosocomial infections just popped into my head. Any obstetricians here who might know if this is true?

And then there's bovine mastitis. I've been looking at all the information I can find here and I really think it's a major market. There are a lot of cows out there and dairy farming is *big* business. In Europe too.

Thanks, Torben