Posted on 07/27/2007 12:34:42 AM PDT by neverdem
A patient has died in a study of an experimental gene therapy, the Food and Drug Administration reported yesterday. The agency said it was investigating the death to determine whether the treatment was to blame.
The case could be another setback for gene therapy, a field with a troubled history and numerous treatment failures, including the death of a teenager in 1999 in an experiment.
The new therapy being tested, made by Targeted Genetics of Seattle, is a virus-based product injected directly in the joints in hope of relieving active inflammatory arthritis. That chronic condition can affect multiple joints and organs, and it is quite different from the wear-and-tear arthritis that commonly occurs with aging.
The patient became ill soon after receiving a second injection, the drug agency said. The date is not exactly clear, but the illness was recognized as a “serious adverse event” last Friday, and the agency immediately suspended the study. That means no more injections can be given. The patient died on Tuesday.
Targeted Genetics and the drug agency said they would not describe the patient’s symptoms or the manner of death until the investigation had been completed. The company and the agency emphasized that it was not known whether the treatment had a role or the death was a coincidence. The agency said the timing was cause for concern.
H. Stewart Parker, chief executive of Targeted Genetics, said, “The patient was dosed one dose and had no issues and came back several months...”
--snip--
Dr. Theodore Friedmann, a professor of pediatrics and head of the gene therapy program at the University of California, San Diego, said the A.A.V. system used in the experiment was widely regarded as safe.
But, Dr. Friedmann added, “We’ll probably come to learn it does some harmful things in some settings.”
(Excerpt) Read more at nytimes.com ...
"they would not describe the patient’s symptoms or the manner of death "
Dying for five days...Lord rest his soul.
Children Conceived by IVF Have Nearly Twice as Many Health Problems
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It’s a pity. IMHO, using viral vectors is too problematic.
I hope the analgesia was adequate.
The problem with nonviral vectors is that they don’t work!
As far as the cause of death, there was a short paper in Science (this week, I think) that reported a high incidence of liver tumors in mice treated with AAV.
This is tragic, nobody thinks that death is an acceptable risk for an arthritis treatment, but further study of this in animals could lead to a test that would determine if a patient is likely to have a bad reaction to the treatment.
It must have been bad....
I know because I cured my RA and my sister who was in far worse shape than I has also been cured.
They were on their way to killing my sister. This story only reinforces my reluctance to go to a doctor. I certainly will go for trauma and maybe some other ailments but nothing of a chronic nature. Do no harm. This poor family stupidly trusted the doctors. I am past that.
I know because I cured my RA and my sister who was in far worse shape than I has also been cured.
If you have a cure for RA, why not tell it to the world so this does not happen again??
The choice of a viral vector leaves much to be desired. How do you limit replication of the virus? What if that replication delivers multiple copies of the gene? Will an overload result in problems? Definitely problematic.
Who knew that the virus for Black Plague would someday become a breakthrough arthritis treatment? Thanks Neverdem.
It was probably 30 years ago I had my RA confirmed more than once with blood tests. The doctor put me on mega doses of aspirin. It was probably only a day or two into that therapy when I realized it wouldn't work. My stomach hurt terribly.
I learned about a book by Adele Davis. I followed her protocol and used Vit C, Pantothentic acid and Vitamin E.
My sister's situation was far worse. She had many autoimmune diseases at once and her liver was being destroyed with methotrexate among other drugs.
I really felt my sister was dying. Out of desperation I went to the internet and found out about a condition called leaky gut syndrome.
I printed the info, took it to her and told her to do with it what she wanted. She decided it sounded posible. She went on the diet, and eventually added many nutritional supplements and got off all drugs except for a thyroid pill.
At one time she was in a wheel chair. She still has problems occasionally with fibromyalgia but the RA and other autoimmune diseases are gone.
Science Fiction title: Revenge of the Unborn
I am as well
I learned a long time ago, doctors are making, in many cases, their best guess in your treatment instead of admitting their opinion is based on limited knowledge or old treatments .
I still trust my doctor to a point, but always get a second opinion on the most serious medical issues I and my family face.
More than once the doctor was wrong.
1. My doctor proscribed me the wrong type of high blood pressure medicine, darn near killed me.
2. My son's doctor recommended he have his ankles bones fused together to fix a bone disorder. He went to a second doctor who considered his problem easily fixed though surgery, which he had done. He is completely fixed instead of walking around like a 85 year old man
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