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Phase II Trials Rejected by JDRF   Message List  
Reply | Forward Message #382 of 634 |
Re: [nathanfaustmantrials] Phase II Trials Rejected by JDRF

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 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: [nathanfaustmantrials] Phase II Trials Rejected by JDRF
To: nathanfaustmantrials@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.    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




Tue May 27, 2008 3:17 pm

susan_root
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Message #382 of 634 |
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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...
Ellen
ellen_crain
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May 26, 2008
3:34 am

Given that JDRF is committed to 'finding a cure', I'm shocked that it's not at least partially funding the research. Recently JDRF gave out some 'awards' and I...
Bernard Farrell
bernfarr
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May 27, 2008
3:38 am

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...
Joshua Levy
joshua2levy
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May 27, 2008
3:39 am

The Letter of Intent rejection by the JDRF is recent. It was submitted in January 2008. As stated previously, it was submitted to ask permission to submit a...
Sue root
susan_root
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May 27, 2008
3:40 am

Joshua, Actions speak louder than words. JDRF's reasoning behind the&nbsp;multiple rejections&nbsp;in 2002-2004 after Dr. Faustman's&nbsp; published...
Sue root
susan_root
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May 27, 2008
8:04 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...
Ellen
ellen_crain
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May 28, 2008
1:32 pm

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...
Sue root
susan_root
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May 28, 2008
9:24 pm

... this research&nbsp;not to be funded and not to go forward. ... Actually, there is a "reason." If they actually let T1 be cured, they'd be out of a job....
Ann
ann_reiling
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May 28, 2008
9:23 pm

If your friend was actually cured for one year don't you think it should be exposed to the media? Every profession goes forward a light speed except medicine,...
imcimc1
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May 30, 2008
12:51 am

NO, of course it couldn't have been "exposed" because it NEVER HAPPENED. He, ahem, was not authorized so it never happened as far as he was concerned. If any...
Ann
ann_reiling
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May 30, 2008
2:42 pm

Well stated Ann. I met a dual kidney/pancreas transplant recipient in Seattle and his rejection meds cost $4,000 a month. He is on Medicaid so the taxpayers...
Kathryn Hunt
kathrynjhunt
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May 30, 2008
1:28 am

actually, Does he posess enough documentation to prove that the project did exist and was getting results? Its high time someone took one for the team and...
ivan roseland
iroseland
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May 30, 2008
4:12 pm

I'd agree with exposing except for 3 things. 1. Even if he had enough to make it irrefutable, what would come of it? Nothing. Perhaps a big media hype which...
Ann
ann_reiling
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May 31, 2008
7:47 pm
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