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Re: [IPp] Re:Dr. Faustman's research

 I emailed JDRF about this research and asked why that they would not help fund
this approach. Read their response below.

Laura's dad diag 1-15-2003
-----Original Message-----
From: Mathis, Diane
To: Insel, Richard
Sent: 11/11/04 10:04
Subject: yes, i sent it there

November 10, 2004

Dear Editor,

 We are disappointed that the New York Times chose to publish an article that
did not present both sides of a scientific debate. We refer to the article "I
Beg to Differ: A Diabetes Researcher Forges Her Own Path to a Cure" published on
Nov. 9, 2004. This piece claims that Dr. Denise
 Faustman of Massachusetts General Hospital has, revolutionarily, cured mice of
type-1 diabetes and insinuates that, were it not for the jealousy of scientific
colleagues and the conflict-of-interest of funding agencies, would be testing
her proven method in human diabetes patients. We would like to refute some of
the more glaring of the many incorrect statements underlying these claims:

  The Nov. 9 article opens with the eye-catching remark that Dr. Faustman is the
only scientist to have cured diabetes in mice. This statement is patently false.
Multiple scientific groups have cured diabetes in mice by multiple means. In
fact, two of the most promising clinical trials currently being conducted on
type-1 diabetes patients are based on a report published in the Proceedings of
the National Academy of Sciences in 1994 that injection of a particular antibody
into mice cures them of their diabetes.

 It is disappointing that the article quotes one of Dr. Faustman's close
colleagues that "most of the things" she has found "turned out to be true". A
better source may have been the public record, which shows that two of Dr.
Faustman's most visible scientific contributions, a report in Science in 1991
and another in Molecular and Cellular Biology in 1999, were soon followed by
letters-to-the-editor from highly respected research groups at multiple
universities around the country attesting that these findings were not
repeatable and/or were being misinterpreted.
  But it is perhaps most important to correct the misconception that the
curative procedure Dr Faustman has used in mice is ready for translation to
humans. This procedure entails injecting two major ingredients into recently
diabetic mice. The first is a drug similar to one called BCG that is a common
component of vaccines, such as the vaccine against TB. The second is an enormous
quantity of spleen cells - the equivalent in humans would be the injection of
cells from 5 human spleens over a period of 4 years. This procedure simply can't
be done in humans. In recognition of this fact, Dr. Faustman and colleagues have
approval only to test the effect of BCG alone on diabetes, but it is not known
to what extent this drug alone reproduces the previously described effects in
mice. We suggest that the article should have reported that the clinical effects
of BCG on type-1 diabetes have already been evaluated in humans in several other
contexts. In one published study, injection!
  of this drug into diabetic adults had no effect on their progression to
disease. In two other studies, it has been found that children at risk of
developing type-1 diabetes actually developed overt disease more rapidly when
they had been vaccinated with BCG. Clearly, doctors must be prudent in
administering this drug to patients.

  Lastly, a comment on the insinuations in the article that translation of Dr.
Faustman's mouse work to the cure of human diabetes is being held up by the
petty jealousies or inconsequential bickering of scientific colleagues, and by
the conflict-of-interest of pharmaceutical companies and funding agencies.
Although such a "black-sheep" strategy can be an effective one, a quick glance
at the facts should serve to show how inappropriate it is. The National
Institutes of Health and, through the generosity of many individual donors,
private organizations such as the Juvenile Diabetes Research Foundation are
currently devoting hundreds of millions of dollars to research on type-1
diabetes. Large fractions of their funds have been set aside for human clinical
trials, and there is active promotion to move promising preventative and
curative strategies from mice to humans, from the bench to the bedside, as
quickly as possible. As a direct result, there are currently some quite p!
  romising leads under active investigation. However, to protect patients from
useless or even harmful interventions, any proposed clinical trial must pass
scientific (and sometimes lay) review before being funded. It would have
balanced the article to report that Dr. Faustman's work has not so far been able
to pass the objective reviews of the agencies she has applied to. And to report
that she has never even applied to the largest government agency that funds
clinical trials on individuals with, or at risk of, type-1 diabetes (TrialNet).
  We offer our most heartfelt apologies, on behalf of Dr. Faustman, to the
individuals with type-1 diabetes, and their families, for having their
expectations cruelly raised by the Nov 9th article. We sincerely hope that your
readers will not lose their confidence in scientists and in the scientific
process. Rest assured that we are aware of the critical need for a cure and are
painfully cognizant of our inability to produce one so far. But also be assured
that we are doing our utmost to find one as soon as we possibly can, and that
there are other avenues that truly do offer hope.


Diane Mathis, Ph. D. and Christophe Benoist, M. D., Ph. D.
Heads, Section on Immunology and Immunogenetics, Joslin Diabetes Center;
Professors of Medicine, Harvard Medical School

> Dear  Friends:
 > On behalf of the Immunobiology Laboratory of Massachusetts General Hospital,
> I
> am writing to you with an update on the progress that has  been made in the
> laboratory.  We are also attaching with this mailing an  update on our 
> research
> that recently appeared in the New York  Times.
> As many of you know, we have identified defects in the immune  system that 
> cause
> the destruction of insulin-producing cells in both the  diabetic mouse and
> diabetic human.  The insulin producing cells are  normally located in the
> pancreas, and the cell clusters are called  islets.  
> Based on these defects, we developed a brief 40-day  therapy that stopped the
> autoimmune system from attacking these cells.   On November 14, 2003, our 
> paper
> was published in Science that shows the  results of a successful reversal of 
> type
> 1 diabetes in mice.  This  discovery has significant implications, not only 
> for
> diabetes, in that the  autoimmune cells were permanently eliminated but the 
> mice
> re-grew the missing  insulin secreting cells in the pancreas.
> We are now expanding this  discovery work on islet regeneration and are
> attempting to develop a human  assay to similarly identify these defects in
> humans for a clinical  trial.  Individuals come to the lab, on a voluntary 
> basis,
 > to donate blood in order to create this assay. These donations of blood (a
> few
> tablespoons) are free to the individual because the costs of the blood  
> testing
> come from research dollars.  
> You might ask why we are  developing this blood test prior to treating type 1
> diabetics.  The  blood test is essential for knowing drug dosing during the
> trial.  If  you did not know your blood sugar, how would you decide the 
> correct
> dose of  insulin?  We need the same blood information but as it relates to  
> the
> numbers of remaining immune cells that can still damage the islets in  the
> pancreas before and during our planned clinical trials.
> The  greatest obstacle in our path is the lack of funds to carry on these
 > clinical trials that we believe could mark a breakthrough in the treatment of
 > diabetes and other diseases. The translation of science from mice to humans
> is
> a  long process but we need to start.  There will be three phases to the  
> clinical
> trial, which will span over approximately 6 years.  Phase I,  the biomarker 
> assay
 > development of the clinical trial and a Phase I testing in humans, will cost
> $11
> million dollars. 
> On August 16, 2004, Mr.  Iacocca, a long-time supporter of this work, 
> announced
> in New York that he  was launching a fundraising campaign called "Join Lee 
> Now".
> Mr. Iacocca has  given $1 million dollars to start the funding for this 
> clinical
> trial.   He is asking the public for small and large donations. 
 > You can further Dr. Faustman's research by donating directly to the research.
> This donation  is a charitable gift and checks should be made out to:
> The  Massachusetts General Hospital - Fund #1200-265233
> This donation can be  mailed to:
> Ms. Lynne Murphy
> C/o Dr. Denise  Faustman
> Director of the Immunobiology Laboratory
> Massachusetts General Hospital-East
> Building 149, 13th  Street, CNY-3601
> Charlestown, MA 02129
> Thank you very  much for your interest in my research and hope that we can go
> forward in the  cure for diabetes.
> Sincerely,
> Denise Faustman, MD, Ph.D.
> Associate  Professor of Medicine
> Harvard Medical School
> Director, Immunobiology Laboratory
> Massachusetts  General Hospital
> 617-726-4084 (Office)
> 617-726-4095 (FAX)
> DF/lmm
> ----------------------------------------------------------
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