Re: Faustman Trials Information


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Posted by answer on 15:53:14 2006/02/02

In Reply to: Re: Faustman Trials Information posted by DaveC


The letter you cite is a misrepresentation of Faustman's work and that issue was addressed in the Diabetes Health article.

Here's a private response to that horrible letter distributed by the JDRF. It's from two mothers, Sue Root and Jackie Fusco, written right after the JDRF took it upon itself to distribute the Mathis/Benoust letter.

Hello All,

We are aware that many of you have seen the attached letter from Dr. Mathis and Dr. Benoist sent to the editor of the New York Times reacting to the article on Dr.
Denise Faustman,"I Beg to Differ: A Diabetes Researcher Forges Her Own Path to a Cure", printed on Nov. 9, 2004. The letter has been widely circulated by
JDRF to its members. We would like you to know some important facts that show the inaccuracies and misrepresentations written in the letter.

(1) Dr. Mathis and Dr. Benoist first refer to the Nov. 9th article's remark that Dr. Faustman is the only scientist to have cured diabetes in mice as "patently false".
They then claim that multiple scientific groups have cured diabetes in mice by multiple means and give the one example of promising clinical trials currently being
conducted based on a study published in the Proceedings of the National Academy of Sciences in 1994. They fail to disclose that this study showed only
new-onset diabetic mice, with remaining functioning islets, experienced a halt in disease progression. The drug used in the study was an immunosuppressive agent and
the treatment did not result in total elimination of the disease. While this treatment therapy offers an exciting approach for newly diagnosed diabetics to prolong the
"honeymoon" phase, it certainly is not considered a cure. One should know that all of the successful treatments (over 180) performed in mice prior to Dr. Faustman's
2001 breakthrough were either before the disease developed or in early onset only. Based on these numbers, one can see that almost any treatment would have an
effect at the preventative or early onset phase. Dr. Faustman's 2001 40-day treatment protocol stands alone for a number of reasons. First, it not only interrupted the
progression to full-blown diabetes in the earlier stages but was also successful at end-stage disease in the mice for the first time ever. There was total elimination of
the disease. There was a return of normal insulin secretion resulting in normal blood glucose levels for the lifetime of the mice without further treatment. No other data
has been published that can produce such results to be called a "cure". This is why we are excited to see if Dr. Faustman's treatment of curing mice with end-stage
diabetes can be successfully translated to humans with full-blown disease.

(2) The letter then states that two of Dr. Faustman's most visible scientific contributions (1991 publication in Science and 1999 publication in Molecular and
Cellular Biology) were soon followed by letters-to-the-editor and turned out to be untrue. This refutes the article's quote by Dr. Joseph Avruch, the chief of the
diabetes research unit at Massachusetts General Hospital, "Most of the things she has found turned out to be true". As one should know, subjective letters to the
editor written immediately after a publication certainly do not replace the validity of published "peer reviewed" scientific data. After all, we're seeing that right now
from Dr. Mathis and Dr. Benoist. Again, the letter fails to inform the reader that Dr. Faustman's discovery publications above were both later supported by the work
of many other groups. That is the true test of the validity of any published research.

(3) Drs. Mathis and Benoist next claim two things when referring to Dr. Faustman's procedure for translation to humans. First, BCG has already been evaluated in
humans with one published study showing no effect with the injection of this drug. Once again, they omit very important facts. The one study to which they refer used
only one dose of BCG. One dose had not worked in the animal model. However, a number of scientific projects exist supporting the use of multiple doses of BCG
and similar stimulants like CFA in mice. Dr. Faustman demonstrated success of eliminating the auto-reactive T cells in the immune system responsible for killing the
islet cells, by using multiple doses of CFA and BCG in mice based on these previous studies. She and Dr. Nathan will be trying to determine if and at what dose
would be effective in the human. Therefore, the study using one BCG dose cannot rule out the possibility that multiple doses of BCG could work effectively in the
human. A good analogy would be the use of antibiotics for infections. We all know that one dose of an antibiotic is not sufficient to eliminate the infection completely.
Furthermore, they lead one to believe that BCG may somehow be dangerous by causing diabetes when referring to two studies on normal children at risk for
developing the disease. They do not consider the research supporting the use of BCG given after the disease has occurred. Dr. Faustman and Dr. Nathan are not
proposing to inject BCG doses into humans without diabetes. So, their argument is not relevant. BCG has been administered to millions of humans over the course
of many many years. It has been used to treat bladder cancer at extremely high doses (750 times the vaccinated dose) and has been used to vaccinate adult diabetics
without harm.

The second claim when referring to Dr. Faustman's research is probably the most troubling. Dr. Mathis and Dr. Benoist propose that Dr. Faustman must inject an
enormous quantity of spleen cells into humans as a second step and this procedure simply cannot be done. Have they actually read Dr. Faustmans' papers? Did they
actually read the New York Times article? They could not be more mistaken because Dr. Faustman and Dr. Nathan are not proposing to inject spleen cells into
humans as any part of a treatment.

(4) Lastly, Dr.'s Mathis and Benoist report that Dr. Faustman has never applied to the largest government agency (TrialNet) that funds clinical trials. You should be
informed that TrialNet does not fund phase I human clinical trials.

Most importantly, the New York Times chose not to publish the letter written by Dr. Mathis and Dr. Benoist. It was sent to the New York Times but rejected based
on the fact that they believed the criticisms in the letter were invalid due to their previous research of all data. We find it most unfortunate that JDRF's Executive Vice
President for Research, Dr. Dick Insel, chose to support unsubstantiated accusations and misleading information about Dr. Faustman's research by distributing the
letter to all of the JDRF Chapters.

JDRF is not supporting the research of Dr. Faustman. They need to stop slandering her research and her reputation as a credible scientist. The inaccurate statements
and misrepresentation of her research, as was presented to JDRF members through the Dr. Mathis and Dr. Benoist letter, only hurts the innocent families hoping
for a potential cure for their loved ones. We are the parents of children with type I diabetes. We don't care who cures diabetes, as long as it happens. We and a
growing number of families have learned of Dr. Faustman and Dr. Nathan's project and are excited to see if their research can lead to a cure. If you want some
additional facts about Dr. Faustman's work and how you can help support these clinical trials with or without the JDRF, please visit www.joinleenow.org.

We have requested a detailed written response from Dr. Faustman including scientific references to support the New York Times article and to demonstrate the
falsities in the Drs. Mathis and Benoist letter. If you are interested, we would be happy to send you a copy.

Thank you for your time.

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