Re: [nathanfaustmantrials] Re: Phase II Trials Rejected by JDRF
My 2 local JDRF chapters were not aware of the recent rejections. I believe that the local chapters around the country are either not aware of this research at all or have misinformation about it or at least are not aware of the progression of this project over the last several years.
It would be a good idea if people could email their local chapters the information just to inform them and state how disappointing it is with the recent rejection despite the successful replication results, the supporting research in regeneration, and the progression of data with human blood samples and the phase i trial in the Faustman lab. At least, the inquiries into JDRFI by the chapters could stir some things.
I doubt very much that they organization will change its mind.
--- On Tue, 5/27/08, Ellen <ecrain1@...> wrote:
From: Ellen <ecrain1@...> Subject: [nathanfaustmantrials] Re: Phase II Trials Rejected by JDRF To: nathanfaustmantrials@yahoogroups.com Date: Tuesday, May 27, 2008, 6:15 PM
Thank you Sue for the very informative information. I am on a mailing list from the JDRF chapter in Illinois. So I get information on all of the fund raisers going on in the area. I also have the e- mail addresses to everyone else who gets this information. I asked everyone including the Chapter representative to sign up and be a part of our Trials Group website. The Chapter Representative was not aware of it and said that she would sign up. I wonder if a letter writing campaign to all of the Chapter representatives in the country would have an impact in JDRF's decision and whether it might still be possible for them to reverse their decision on this. What does everyone think?
Ellen
--- In nathanfaustmantrial s@yahoogroups. com, Sue root <susan_root@ ...> wrote: > > > >
> > Joshua, > Actions speak louder than words. > JDRF's reasoning behind the multiple rejections in 2002- 2004 after Dr. Faustman's published discovery that led to reversing and curing diabetes in adult endstage diseased NOD mice for the first time was that they needed to replicate the research. The research was replicated successfully by 5 independent labs (including an NIH group with 100% success). > I have a 2004 letter written to me by the head of the JDRF Lay Review Committee at that time. She and that committee's job is to act as the unbiased review for the best research leading to a cure for the disease and to represent the many families of children with type I diabetes who are members of JDRF. In that letter, she makes 2 statements about Dr. Faustman's research: > 1.BCG has already been ruled out in humans in the past
with failed human trials. The past human trials that she refers to used only 1 vaccinated dose of BCG in early onset patients. Back then, BCG had an effect in preventing diabetes in mice with this low dose, but the scientists did not know how or why and went into human trials anyway. The Faustman lab has shown that 1 vaccinated dose is not enough to have an end effect of normoglycemia. The Faustman lab has shown that the effect of an immune stimulant like BCG and CFA results in the body's production of TNF alpha which kills off the autoreactive T cells (This was replicated in mice I believe in Canada). The lab can now measure this effectively in humans and knows that it will take much more than 1 vaccinated dose to have the chance of depleting all of the
autoreactive T cells and possibly seeing any increase in > C-peptide, decrease in insulin requirements or normoglycemia. > > 2. Spleen cell transplants can't be used as a treatment to cure diabetes. The Faustman lab has never had any plan to use spleen cell transplants as part of their protocol to cure diabetes in humans. One other important thing to mention. Here you have the head of the lay review committee making this statement, which has been repeated by other JDRF sources in the past. However, if you look on the JDRF website under JDRF funded research, the replication of Dr. Faustman's mice research by Anita Chong states "Should we observe successfully differentiation of splenocytes into insulin-secreting cells, we will embark on a clinical trial of human splenocyte transplantation. .." >
> Dr. Faustman's research has been published in peer-review world renowned science journals. Her publications have been sited in the reference sections of other scientists publications, including JDRF funded ones. Dr. Faustman's research has been reviewed and supported positively by the Massachusetts General Hospital's internal review board and the Iacocca Foundation's scientific reveiw board. > JDRF is well aware of the research that is going on in the Faustman lab. > > I took 9 months and read& nbsp;the published science papers by Dr. Faustman and kept asking questions. I also took this time to read published science papers by other scientists and contacted many of them in the US and other countries to ask specific questions about their mice research. > Nobody can guarantee that the Faustman/Nathan human trial will succeed. >
However, I can state one thing..there is no reason what so ever for this research not to be funded and not to go forward. > Sue > > > > --- On Mon, 5/26/08, Joshua Levy joshua2levy@ ... wrote: > > From: Joshua Levy joshua2levy@ ... > Subject: Re: [nathanfaustmantria ls] Phase II Trials Rejected by JDRF > To: nathanfaustmantrial s@yahoogroups. com > Date: Monday, May 26, 2008, 12:01 PM > > > > > > > > > > > > > > > > > Ellen write the text in Blue: > > Why does JDRF keep rejecting Dr. Faustman? > > We can not answer this question, because none of us knows why JDRF does anything that it does. We can only
speculate. We can say things like "I think JDRF rejected it because of blah blah blah" or "It's obvious [in my opinion] that JDRF rejected it because of blah blah blah" or anything else. But these things come from us and not JDRF. And they are all just blah blah blah. And it says much more about what we believe, than why JDRF did what it did. > > > > > > > > Does JDRF know something that we don't know about this research? > > JDRF has whatever detailed request that Faustman gave them, both now and in the past. You can be sure that they have also read every paper that Faustman has published in this area. & nbsp; Who on this list has done all that? So I think that it is very fair to say that JDRF knows something that we don't know about Faustman's
research. Not some secret knowledge, but all the publicly available knowledge (and read by people who do diabetes research professionally, and who have very wide experience in this area). "We" on the other hand, mostly have not read Faustmans funding requests. "We" mostly have not read her published papers, etc. Who among us has read all of this work and compared it to the similar work done elsewhere? > Joshua Levy >
Why does JDRF keep rejecting Dr. Faustman? Was the Letter of Intent a recent letter or was it submitted with the request for Phase I trials? Does JDRF know...
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Ellen write the text in Blue: Why does JDRF keep rejecting Dr. Faustman? We can not answer this question, because none of us knows why JDRF does anything that...
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Thank you Sue for the very informative information. I am on a mailing list from the JDRF chapter in Illinois. So I get information on all of the fund raisers...
My 2 local JDRF chapters were not aware of the recent rejections. I believe that the local chapters around the country are either not aware of this research at...
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