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» LymeNet Flash » Questions and Discussion » Medical Questions » Patient dies after researchers inject viruses for arthritis, study resuming

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Author Topic: Patient dies after researchers inject viruses for arthritis, study resuming
pineapple
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Halted gene therapy study to resume

By LINDSEY TANNER, AP Medical Writer
Mon Nov 26, 6:09 PM ET


CHICAGO - A gene therapy study halted after an arthritis patient died will resume with one main change: participants won't get injections if they have signs of infections, the treatment's developer said Monday.

While an investigation indicated gene therapy injections didn't kill the patient, Targeted Genetics Corp. is being cautious in resuming the study of what it considers a potentially promising treatment for inflammatory arthritis.

Jolee Mohr had a slight fever -- a sign of infection -- when she received the last of two injections at a Springfield, Ill., clinic on July 2. She died three weeks later after doctors discovered a massive fungal infection and internal bleeding.

Targeted Genetics has chosen a "conservative" approach in resuming the experiment, chief executive officer H. Stewart Parker said in a telephone interview Monday. Of 127 total participants, 35 still need a second shot and will be told of Mohr's death when the study resumes, the company said.

Investigation participants included the company, the U.S. Food and Drug Administration and the University of Chicago Medical Center, where Mohr was transferred after she fell ill and where she died. Final results are to be discussed at a federal gene therapy committee meeting on Dec. 3 at the National Institutes of Health outside Washington.

Panelists at a previous NIH committee meeting in September had raised concerns about Mohr receiving the experimental treatment when she already had signs of illness.

Questions also had been raised about whether genetically engineered viruses injected into patients' joints as part of the experiment might spread throughout the body, causing illness.

But tests on Mohr found only trace amounts in tissues outside her joints, not enough to have contributed to her death, said Dr. Kyle Hogarth, a University of Chicago physician who treated Mohr after she fell ill.

Seattle-based Targeted Genetics believes arthritis medicine Mohr already was taking, which has been linked to an increased risk for fungal infections, likely played a role.

Hogarth said "it's great" that the study is resuming because the experimental treatment could be useful. But he also said troubling questions remain, including why participants will be allowed to continue taking arthritis medicine that could complicate efforts to prove that the gene treatment is safe.

Hogarth also noted that Mohr's own doctor recruited her for the study and also performed the experimental treatment, which he said raises ethical concerns. That's because patients tend to trust that their doctors are working in their behalf, and so Mohr could have mistakenly assumed he was recommending an already proven treatment.

Alan Milstein, an attorney for Mohr's husband, Robb, said the family still believes her death was avoidable.

The study involved injecting patients with trillions of genetically engineered viruses carrying a gene intended to help the body produce an inflammation-fighting protein.

The FDA halted the study after Mohr's death but last week told the company it could continue.

"We believe this is a vindication for the product and for the gene therapy field in general," Parker said.

While the study's first phase was to examine safety, there were early indications that the experimental treatment helped relieve pain for those with inflammatory arthritis, Parker said. Inflammatory arthritis includes rheumatoid arthritis and affects more than 2 million Americans.


http://news.yahoo.com/s/ap/20071126/ap_on_he_me/gene_therapy_1

Posts: 339 | From nowhere | Registered: May 2007  |  IP: Logged | Report this post to a Moderator
luvs2ride
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Inject me with viruses?

No thanks. I have plenty of my own.

Luvs

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When the Power of Love overcomes the Love of Power, there will be Peace.

Posts: 3038 | From america | Registered: Oct 2005  |  IP: Logged | Report this post to a Moderator
randibear
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you have got to be kidding!!! being used as a lab rat, no way.......

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do not look back when the only course is forward

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roro
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why would ANYONE voluntarily let themselves be injected with viruses??!!!???
Posts: 615 | From maryland | Registered: Oct 2007  |  IP: Logged | Report this post to a Moderator
Bitrex
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quote:
Originally posted by roro:
why would ANYONE voluntarily let themselves be injected with viruses??!!!???

Viruses are used as vectors in experimental gene therapy. There are many viruses that do not cause illness in humans, but can still be used as gene carrying "transports." The basic idea is that when the virus enters a a human cell with malfunctioning DNA, the RNA genome of the virus (which has been modified with a version of the "correct" sequence for the malfunctioning human cell) will be reverse transcribed into the host's DNA sequence when the virus uses the cell's machinery to replicate. This process is known as "transduction."


It's not really as simple as that, as the person's immune response to the viral vector can cause problems, and there is often no way to predict where in a cell's DNA the replacement strand actually ends up. Like the article said though, it doesn't seem like the poor woman in the story died as a direct result of the experimental treatment, as she was suffering from a massive fungal infection rather than viral. Unfortunately once experimental treatments reach a certain number of patients there are probably going to be deaths for one reason or another - the data sheets for almost all drugs out there contain statistics on the number of patient deaths that occurred during trials.


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Truthfinder
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***''........ injecting patients with trillions of genetically engineered viruses carrying a gene intended to help the body produce an inflammation-fighting protein.``***

Boy, you have to wonder.... I mean, it seems that the trick with any anti-inflammatory substance is to reduce excess inflammation WITHOUT compromising immune function. (After all, that's really what the whole Vitamin D controversy is all about on this board....)

I hope they can get to the bottom of this.... at least indirectly, there certainly could be a connection here.

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Tracy
.... Prayers for the Lyme Community - every day at 6 p.m. Pacific Time and 9 p.m. Eastern Time � just take a few moments to say a prayer wherever you are�.

Posts: 2966 | From Colorado | Registered: Dec 2005  |  IP: Logged | Report this post to a Moderator
map1131
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But knowing how poor testing is for bacteria, virus, fungi, etc is scarey for us? An immune system already in overdrive due to unknown?

Lets throw something else on top of it. Seems to me with her it was a "sink or swim" test.

Anyone she how old this woman was? How sad.

Pam

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"Never, never, never, never, never give up" Winston Churchill

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bettyg
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bitrex,

what is your medical background? that was a very informative post you wrote! thanks [Wink]

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