Are the researchers telling you that $12,000 must be provided by you in
order for them to even review your child's condition?  Or is this the
cost of the protocol itself if he is eligible after their review?  That
seems pretty steep just to "review" his condition is why I ask.

Thanks,

Stacy Lavery

Moderator, Nathan/Faustman Trials Yahoo Group


--- In nathanfaustmantrials@yahoogroups.com, "jawad_majed"
<jawad_majed@...> wrote:
>
> -
> I have contacted the clinic. I was informed that treating my son who
has been diabetic for 5 years (10 years old now) is possible. I filled
an on line form to have them review his condition. The cost is aprox.
8700 euros ($12000), excluding travel cost.
>
> In relation to our clinical triles (faustman's). My understanding is
that once we have some positive feed back out of the 1st triles, it will
be much smoother to raise funds.
> --
>
> In nathanfaustmantrials@yahoogroups.com, Sue root susan_root@ wrote:
> >
> > Hi Karin
> >   I understand your feelings about the time-line for the Faustman
project. However, in reality, the original time-line and goals of the
project never changed. Dr. Faustman began seeking funding for the
preclinical work and phase I human trial in 2002. The original estimated
$11 million for a total of 3 years (18 months of preclinical work and 18
months for phase I) never changed. The rejections and skeptism by the
science community and world renowned JDRF organization directly
interfered with getting adequate funding to start the project. Even when
the Iacocca Foundation launched its "Join Lee Now' campaign in August of
2004, it took almost 2 years to raise the money. Dr. Faustman's lab did
not start to get the adequate funding until July of 2006. Eighteen
months later, as predicted, the phase I human trial started in January
of 2008 and is expected to be finished sometime this July. As you and
everyone can see, once the financial support finally got to
> > the lab in July 2006, 3 years later - as originally estimated - the
work has been achieved.
> > I hear your statements all the time and people are wrong when they
blame the research as the problem for the delays. We will have the same
problem when trying to start phase II of the human trial by the end of
the year or early 2010 if we don't get the funding needed.
> > After following this research since 2002 and raising over $1 million
for it with an amazing group of women, every scientific goal has been
surpassed thus far and the ONLY thing interfering with its progression
is money.
> > As far as the research in Germany, my opinion is to read the
published data and contact the scientists directly to get the correct
information.
> >
> > Sue
> >
> > --- On Tue, 6/2/09, Karin Espelage kespelage@ wrote:
> >
> > From: Karin Espelage kespelage@
> > Subject: Re: [nathanfaustmantrials] Re: cure for type1 diabetes???
> > To: nathanfaustmantrials@yahoogroups.com
> > Date: Tuesday, June 2, 2009, 1:15 PM
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> > "..and she told
> > me that these countries do this all of the time - promise American's
a cure,
> > only to take their money."
> >
> > Boy, you sure
> > make my native country sound like a shady banana republic! :-)
Germany
> > and the EU have very strict regulations for everything related to
> > healthcare. I don't know anything about this clinic but I have a
hard time
> > believing that a German hospital just makes total bogus claims on a
> > public website to cheat Americans out of their money...
> >
> > I've been
> > subscribed to this group for a while. I used to donate to the
Faustman research
> > regularly. I got  frustrated though after the frequent shifts in the
> > promised timeline (and my German relatives whom I asked to donate
too now think
> > they've just given their money away to some shady American
> > organization. ..). I understand that human trials are now finally
underway. Is
> > there any information about how it's going so far?
> >
> >
> > Thanks,
> > Karin
> >
> >
> >
> >
> >
> >
> > ----- Original Message -----
> > From:
> > Ellen
> >
> > To: nathanfaustmantrial s@yahoogroups. com
> >
> > Sent: Monday, June 01, 2009 7:35 PM
> > Subject: [nathanfaustmantria ls] Re: cure
> > for type1 diabetes???
> >
> >
> >
> > I don't know about that particular website, but I do know that when
my son
> > was first diagnosed with Type 1 diabetes, 14 years ago, there was an
article
> > in our local paper for a fund raiser for a six year old who was
going to go to
> > Germany to be cured of Type 1 diabetes. I called the mother, and
they were
> > going to use islet cells. This was before the islet cell success in
Canada.
> > She went there, and was not cured. In fact, her blood sugar control
never got
> > better. They claimed that it was because she was too high and under
too much
> > stress during the journey to Germany. I spoke to my son's endo about
it, and
> > she told me that these countries do this all of the time - promise
American's
> > a cure, only to take their money.
> >
> > --- In nathanfaustmantrial s@yahoogroups. com,
> > "jawad_majed" <jawad_majed@ ...> wrote:
> > >
> > > I have come
> > across this clinic in germany ( www.xcell-center. com )They claim
that
> > they can cure diabetes 1 and 2 through adult stem cell treatment
which sounds
> > simple and cost effective. Any thoughts on this?
> > >
> >
>

-
I have contacted the clinic. I was informed that treating my son who has been
diabetic for 5 years (10 years old now) is possible. I filled an on line form to
have them review his condition. The cost is aprox. 8700 euros ($12000),
excluding travel cost.

In relation to our clinical triles (faustman's). My understanding is that once
we have some positive feed back out of the 1st triles, it will be much smoother
to raise funds.
--

  In nathanfaustmantrials@yahoogroups.com, Sue root <susan_root@...> wrote:
>
> Hi Karin
>   I understand your feelings about the time-line for the Faustman project.
However, in reality, the original time-line and goals of the project never
changed. Dr. Faustman began seeking funding for the preclinical work and phase I
human trial in 2002. The original estimated $11 million for a total of 3 years
(18 months of preclinical work and 18 months for phase I) never changed. The
rejections and skeptism by the science community and world renowned JDRF
organization directly interfered with getting adequate funding to start the
project. Even when the Iacocca Foundation launched its "Join Lee Now' campaign
in August of 2004, it took almost 2 years to raise the money. Dr. Faustman's lab
did not start to get the adequate funding until July of 2006. Eighteen months
later, as predicted, the phase I human trial started in January of 2008 and is
expected to be finished sometime this July. As you and everyone can see, once
the financial support finally got to
>  the lab in July 2006, 3 years later - as originally estimated - the work has
been achieved.
> I hear your statements all the time and people are wrong when they blame the
research as the problem for the delays. We will have the same problem when
trying to start phase II of the human trial by the end of the year or early 2010
if we don't get the funding needed.
> After following this research since 2002 and raising over $1 million for it
with an amazing group of women, every scientific goal has been surpassed thus
far and the ONLY thing interfering with its progression is money.
> As far as the research in Germany, my opinion is to read the published data
and contact the scientists directly to get the correct information.
>
> Sue
>
> --- On Tue, 6/2/09, Karin Espelage <kespelage@...> wrote:
>
> From: Karin Espelage <kespelage@...>
> Subject: Re: [nathanfaustmantrials] Re: cure for type1 diabetes???
> To: nathanfaustmantrials@yahoogroups.com
> Date: Tuesday, June 2, 2009, 1:15 PM
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
> "..and she told
> me that these countries do this all of the time - promise American's a cure,
> only to take their money."
>  
> Boy, you sure
> make my native country sound like a shady banana republic! :-) Germany
> and the EU have very strict regulations for everything related to
> healthcare. I don't know anything about this clinic but I have a hard time
> believing that a German hospital just makes total bogus claims on a
> public website to cheat Americans out of their money...
>  
> I've been
> subscribed to this group for a while. I used to donate to the Faustman
research
> regularly. I got  frustrated though after the frequent shifts in the
> promised timeline (and my German relatives whom I asked to donate too now
think
> they've just given their money away to some shady American
> organization. ..). I understand that human trials are now finally underway. Is
> there any information about how it's going so far?
>
>
> Thanks,
> Karin
>  
>  
>
>  
>  
>
>   ----- Original Message -----
>   From:
>   Ellen
>
>   To: nathanfaustmantrial s@yahoogroups. com
>
>   Sent: Monday, June 01, 2009 7:35 PM
>   Subject: [nathanfaustmantria ls] Re: cure
>   for type1 diabetes???
>
>
>
>   I don't know about that particular website, but I do know that when my son
>   was first diagnosed with Type 1 diabetes, 14 years ago, there was an article
>   in our local paper for a fund raiser for a six year old who was going to go
to
>   Germany to be cured of Type 1 diabetes. I called the mother, and they were
>   going to use islet cells. This was before the islet cell success in Canada.
>   She went there, and was not cured. In fact, her blood sugar control never
got
>   better. They claimed that it was because she was too high and under too much
>   stress during the journey to Germany. I spoke to my son's endo about it, and
>   she told me that these countries do this all of the time - promise
American's
>   a cure, only to take their money.
>
> --- In nathanfaustmantrial s@yahoogroups. com,
>   "jawad_majed" <jawad_majed@ ...> wrote:
> >
> > I have come
>   across this clinic in germany ( www.xcell-center. com )They claim that
>   they can cure diabetes 1 and 2 through adult stem cell treatment which
sounds
>   simple and cost effective. Any thoughts on this?
> >
>

----- Original Message -----

From: Ellen

To: nathanfaustmantrials@yahoogroups.com

Sent: Monday, June 01, 2009 7:35 PM

Subject: [nathanfaustmantrials] Re: cure for type1 diabetes???

I don't know about that particular website, but I do know that when my son was first diagnosed with Type 1 diabetes, 14 years ago, there was an article in our local paper for a fund raiser for a six year old who was going to go to Germany to be cured of Type 1 diabetes. I called the mother, and they were going to use islet cells. This was before the islet cell success in Canada. She went there, and was not cured. In fact, her blood sugar control never got better. They claimed that it was because she was too high and under too much stress during the journey to Germany. I spoke to my son's endo about it, and she told me that these countries do this all of the time - promise American's a cure, only to take their money.

--- In nathanfaustmantrials@yahoogroups.com, "jawad_majed" <jawad_majed@...> wrote:
>
> I have come across this clinic in germany ( www.xcell-center.com )They claim that they can cure diabetes 1 and 2 through adult stem cell treatment which sounds simple and cost effective. Any thoughts on this?
>

I don't know about that particular website, but I do know that when my son was
first diagnosed with Type 1 diabetes, 14 years ago, there was an article in our
local paper for a fund raiser for a six year old who was going to go to Germany
to be cured of Type 1 diabetes.  I called the mother, and they were going to use
islet cells.  This was before the islet cell success in Canada.  She went there,
and was not cured. In fact, her blood sugar control never got better. They
claimed that it was because she was too high and under too much stress during
the journey to Germany.  I spoke to my son's endo about it, and she told me that
these countries do this all of the time - promise American's a cure, only to
take their money.

--- In nathanfaustmantrials@yahoogroups.com, "jawad_majed" <jawad_majed@...>
wrote:
>
> I have come across this clinic in germany ( www.xcell-center.com )They claim
that they can cure diabetes 1 and 2 through adult stem cell treatment which
sounds simple and cost effective. Any thoughts on this?
>

I have come across this clinic in germany ( www.xcell-center.com )They claim
that they can cure diabetes 1 and 2 through adult stem cell treatment which
sounds simple and cost effective. Any thoughts on this?

Did everyone read about the Smart Insulin article in JDRF's Countdown this
month?  Until Dr. Faustman pefects an agent to kill off those autoimmunue
antibodies I would look forward to taking this insulin.  Read about it on
www.smartinsulin.com

http://tinyurl.com/cd4t2z

Lara

I wonder why they have to mention the stem cell stuff here, when her
research clearly doesn't use stem cells?  Perhaps it is just the
reporter's way of drawing attention to the article, but it always
creates such confusion.  Ugh!

Stacy Lavery


--- In nathanfaustmantrials@yahoogroups.com, "Carla" <shortmuffin79@...>
wrote:
>
> Diabetes Cure On The Agenda At BU Event - Dr. Denise Faustman To
Present Keynote Lecture At Science Day
>
> 19 Mar 2009
>
> President Obama's recent reversal of restrictions on stem cell
research is welcomed news for scientists nationwide-scientists like
Boston's Dr. Denise Faustman, who will describe her controversial
approach to curing type 1 diabetes and other autoimmune diseases at 1
p.m. March 26 at 670 Albany Street on Boston University's Medical
Campus.
>
> Dr. Faustman's lecture is the highlight of Boston University Goldman
School of Dental Medicine (BUGSDM) Science Day, and is open to anyone
interested in innovative research underway in Boston.
>
> Dr. Faustman has shown in mouse trials that removing disease-causing T
cells leads to regeneration of good cells and cures type 1 diabetes. She
will speak about human applications of her research at Science Day.
>
> Dr. Faustman is an associate professor at Harvard Medical School and
director of the Immunobiology Laboratories at Massachusetts General
Hospital.
>
> Science Day also features research poster presentations and oral
presentations by BUGSDM students and fellows on a variety of dental and
medical topics and an exhibition by dental vendors. For more
information, visit http://www.dentalschool.bu.edu/scienceday.
>

Diabetes Cure On The Agenda At BU Event - Dr. Denise Faustman To Present Keynote
Lecture At Science Day

19 Mar 2009

President Obama's recent reversal of restrictions on stem cell research is
welcomed news for scientists nationwide-scientists like Boston's Dr. Denise
Faustman, who will describe her controversial approach to curing type 1 diabetes
and other autoimmune diseases at 1 p.m. March 26 at 670 Albany Street on Boston
University's Medical Campus.

Dr. Faustman's lecture is the highlight of Boston University Goldman School of
Dental Medicine (BUGSDM) Science Day, and is open to anyone interested in
innovative research underway in Boston.

Dr. Faustman has shown in mouse trials that removing disease-causing T cells
leads to regeneration of good cells and cures type 1 diabetes. She will speak
about human applications of her research at Science Day.

Dr. Faustman is an associate professor at Harvard Medical School and director of
the Immunobiology Laboratories at Massachusetts General Hospital.

Science Day also features research poster presentations and oral presentations
by BUGSDM students and fellows on a variety of dental and medical topics and an
exhibition by dental vendors. For more information, visit
http://www.dentalschool.bu.edu/scienceday.

I can't speak to the toxicity of the dosage used in the trial mice. When I spoke
with Dr. Faustman at some length (see DiabetesDaily interview) she mentioned
that CFA was toxic to humans. This was in the context of discussing whether a
single dose of BCG would 'cure' diabetes. She said that in mice CFA seems to be
a permanent cure with a single dose. But to develop the same for humans would
require new drug development.

I suspect (not from talking with her) that if BCG works, we'll end up taking a
dose of BCG on a regular basis in place of insulin. But we won't need to test
our blood sugar. I'd inject daily if I knew that highs and lows were gone. That
would be a huge win for me.

Bernard
http://blog.bernardfarrell.com/


--- In nathanfaustmantrials@yahoogroups.com, "Ivan Roseland" <iroseland@...>
wrote:
>
> --- In nathanfaustmantrials@yahoogroups.com, Joshua Levy <joshua2levy@> wrote:
> >
> >
> > Faustman's new lab web page contains the following quote:
> >
> > In research published in 2001 in the Journal of Clinical Investigation and
in 2003 in Science,
> > Dr. Faustman and colleagues used a brief, non-toxic treatment to induce
> > TNF-a in end-stage diabetic mice and permanently eliminate their
> > disease.
> > (from http://www.faustmanlab.org/research/research.html)
> > But this is an obvious mistake: Faustman's treatment described in the paper
uses CFA, which is highly toxic to people and animals.
> >
> > Take a  look at the 2001 paper.  The abstract clearly says:
> >
> > Hyperglycemic NOD mice were treated with CFA to induce TNF-ďż˝ expression
> > and were exposed to functional complexes of MHC class I molecules and
> > antigenic peptides either by repeated injection of MHC class I matched
> > splenocytes or by transplantation of islets from nonautoimmune donors.
> > (from http://www.jci.org/articles/view/12335)
> >
> > And CFA (Complete Freud's Adjuvant) is well known to be toxic.  So toxic
that it can not be used in people at all, and is discouraged even in animals, as
show here:
> >
> > (CFA) is quite toxic and cannot be used in humans.
> > (from
http://books.google.com/books?id=TFoIXMe-UEEC&pg=PA403&lpg=PA403&dq=complete+Fre\
und%27s+adjuvant+CFA+safety&source=web&ots=dYXKq2PcQ-&sig=zrlavn3Lmahle2DArr02aE\
1_Ib8&hl=en&sa=X&oi=book_result&resnum=10&ct=result)
> > and also
> >
> > The undesirable side effects attributed to CFA use include increased pain
and suffering and morbidity in inoculated test animals
> > (from http://www.vcu.edu/oehs/chemical/biosafe/CFAinfo.pdf)
> > and here:
> >
> > The
> > best example of this is complete Freund's adjuvant (CFA). While it
> > remains the gold standard in terms of adjuvant potency, its extreme
> > reactogenicity and toxicity precludes its use in human vaccines, and
> > there have been discussions of banning CFA even in veterinary vaccines.
> > (from
http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/New-A\
ge-Vaccine-Adjuvants-Friend-or-Foe/ArticleStandard/Article/detail/444996)
> >
> > So it sounds like the description of Faustman's treatment as "non-toxic', as
is done in her lab's web site, is a mistake.  The experiment used CFA, which is
toxic.   Or is there something I'm missing?  Does someone know why Faustman's
web page refers to this treatment as non-toxic? Is there something about her
formulation or dosing that makes it safe?  (This question has nothing to do with
the safety of Faustman's current clincial trial, because that trial uses BCG. 
From a safety point of view, BCG and CFA are quite different.)
> >
> > Joshua Levy
> >
>
>
> I think by non-toxic they meant a doseage that was not known to cause the
toxic side effects... Also, she has made a point of telling folks that part of
the research is to find a human tolerable replacement for CFA.
>
> Ivan

--- In nathanfaustmantrials@yahoogroups.com, Joshua Levy <joshua2levy@...>
wrote:
>
>
> Faustman's new lab web page contains the following quote:
>
> In research published in 2001 in the Journal of Clinical Investigation and in
2003 in Science,
> Dr. Faustman and colleagues used a brief, non-toxic treatment to induce
> TNF-a in end-stage diabetic mice and permanently eliminate their
> disease.
> (from http://www.faustmanlab.org/research/research.html)
> But this is an obvious mistake: Faustman's treatment described in the paper
uses CFA, which is highly toxic to people and animals.
>
> Take a  look at the 2001 paper.  The abstract clearly says:
>
> Hyperglycemic NOD mice were treated with CFA to induce TNF-á expression
> and were exposed to functional complexes of MHC class I molecules and
> antigenic peptides either by repeated injection of MHC class I matched
> splenocytes or by transplantation of islets from nonautoimmune donors.
> (from http://www.jci.org/articles/view/12335)
>
> And CFA (Complete Freud's Adjuvant) is well known to be toxic.  So toxic that
it can not be used in people at all, and is discouraged even in animals, as show
here:
>
> (CFA) is quite toxic and cannot be used in humans.
> (from
http://books.google.com/books?id=TFoIXMe-UEEC&pg=PA403&lpg=PA403&dq=complete+Fre\
und%27s+adjuvant+CFA+safety&source=web&ots=dYXKq2PcQ-&sig=zrlavn3Lmahle2DArr02aE\
1_Ib8&hl=en&sa=X&oi=book_result&resnum=10&ct=result)
> and also
>
> The undesirable side effects attributed to CFA use include increased pain and
suffering and morbidity in inoculated test animals
> (from http://www.vcu.edu/oehs/chemical/biosafe/CFAinfo.pdf)
> and here:
>
> The
> best example of this is complete Freund's adjuvant (CFA). While it
> remains the gold standard in terms of adjuvant potency, its extreme
> reactogenicity and toxicity precludes its use in human vaccines, and
> there have been discussions of banning CFA even in veterinary vaccines.
> (from
http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/New-A\
ge-Vaccine-Adjuvants-Friend-or-Foe/ArticleStandard/Article/detail/444996)
>
> So it sounds like the description of Faustman's treatment as "non-toxic', as
is done in her lab's web site, is a mistake.  The experiment used CFA, which is
toxic.   Or is there something I'm missing?  Does someone know why Faustman's
web page refers to this treatment as non-toxic? Is there something about her
formulation or dosing that makes it safe?  (This question has nothing to do with
the safety of Faustman's current clincial trial, because that trial uses BCG. 
From a safety point of view, BCG and CFA are quite different.)
>
> Joshua Levy
>


I think by non-toxic they meant a doseage that was not known to cause the toxic
side effects... Also, she has made a point of telling folks that part of the
research is to find a human tolerable replacement for CFA.

Ivan

With all due respect, Joshua, I have to disagree with you on several
elements.

First, you should be advised that the FDA guidance [Docket No.
FDA-2008-D-0118 "Guidance for Industry on Diabetes Mellitus:
Developing Drugs and Therapeutic Biologics for Treatment and
Prevention"] is far more detailed than the letter which was sent to
the pharmaceutical industry, so you are commenting on
less-than-complete information.  The actual FDA guidance, which was
first issued in draft form back in March 2008, makes no distinction
between treatments for type 1 or type 2 diabetes mellitus.  The new
guidance with regards to drugs (which incidentally, applies to
insulin, even though it is clearly a biotechnology medicine, but one
which is governed by the Federal Food Drug and Cosmetics Act and is
therefore considered to be a "drug" not a vaccine or other biotech
medicine) apply to both.   Until recently, the ONLY criteria the FDA
used is what it refers to as a "surrogate endpoint", which has always
been a reduction in HbA1c, so anything other than a reduction in
tended to be viewed as irrelevant to an approval decision (adverse
effects, are a separate evaluation criteria).  I need not remind
everyone that a commentary article published in the September 29, 2007
edition of The Lancet entitled "Patient-important outcomes in
diabetesâ€"time for consensus" in which the authors, largely from the
Mayo Clinic, report that a majority of diabetes clinical trials in the
U.S. ignore virtually everything EXCEPT glycemic control (as measured
by HbA1c).  The authors of that article eloquently wrote:

"Unfortunately, HbA1c loses its validity as a surrogate marker when
patients have a constellation of metabolic abnormalities, when the
most common complications are macrovascular, and when the treatments
have multiple poorly understood effects."

In the FDA guidance, the FDA does provide some guidance relevant to
type 1 treatments which you SHOULD be concerned about since it does
impact type 1 patients.  First, science has proven unequivocally that
that a majority of patients newly-diagnosed with type 1 diabetes are
pediatrics, and that well-managed diabetes is, in the words of Dr.
William H. Polonsky, the leading cause of nothing. In addition, we
know that many patients with type 2 diabetes are overweight which is
itself a cause of cardiovascular disease, while the same is not
typically true for most patients with type 1 diabetes. Therefore the
recommendation to work with cardiologists specifically in evaluation
of treatments for type 1 diabetes seems to be an exercise in
unnecessary bureaucracy that is unlikely to yield significant benefit
in this particular segment of the population, while simultaneously
adding unnecessary development expense and could actually discourage
the development of new therapies for type 1 diabetes as a result.

In addition, more recent evidence [e.g. S Devaraj, N Glaser, S
Griffen, J Wang-Polagruto, E Miguelino and I Jialal; "Increased
Monocytic Activity and Biomarkers of Inflammation in Patients With
Type 1 Diabetes"; Diabetes 2006 Mar 55: 774-779.] suggests that in
type 1 diabetes, cardiovascular disease has an autoimmune etiology,
thus aside from more aggressive and perhaps earlier treatment of the
known risk factors, there appears to be little the FDA can effectively
do to address the issue of cardiovascular disease in type 1 diabetes
as part of diabetes treatments beyond the general recommendations
applicable for the health of all Americans.  The guidance to
demonstrate a reduction in cardiovascular disease is an added burden
on an industry that shows little interest in developing better
treatments for type 1 diabetes anyway -- while they simultaneously
lust after the enormous type 2 market.

Second, the new guidance (see Lines 277-280) overlooks the fact that
treatments could potentially emerge which serve to regenerate
pancreatic beta cells/Islets of Langerhans thus restoring endogenous
insulin production, therefore the statement that "all experimental
treatments for type 1 diabetes (and their matching placebos, as
applicable) that are not insulin analogues or other insulin receptor
ligands should be studied as add-on therapies to insulin" demonstrates
the FDA's orthodox (and foolish) adherence to approve only therapies
which aim to maintain chronic treatment of the disease, rather than
actually curing the disease. When I wrote to the FDA last March, I
suggested that they revise the language to read as follows: "all
experimental treatments for type 1 diabetes (and their matching
placebos, as applicable) that are not insulin analogues or other
insulin receptor ligands should be studied as add-on therapies to
insulin UNLESS THEY SPECIFICALLY AIM TO INDUCE BETA CELL REGENERATION
AND CAN RESULT IN SUSTAINED INSULIN INDEPENDENCE."

While no one would question the need for safer medicines, one should
question the "surrogate endpoint" as the primary evaluation criteria,
while also asking whether the incidence of cardiovascular disease
should carry the same weight for both type 1 and type 2 diabetes.
Also, they should do more to ascertain whether the diabetes is causal
of cardiovascular disease, or whether it is merely a comorbidity of
something else -- in the case of many type 2's, obesity plays a role,
whereas in the case of type 1, autoimmunity appears to be an important
factor.

Post-market approval is important, and we should be asking why the FDA
currently has NO SYSTEM in place to gather post-marketing analysis for
approved drugs; most of the data is derived from other sources, such
as the Department of Veterans Affairs (using the VA database), but
anyone who has seen the data gathering ability for the FDA --
especially post-market analysis -- is saddened by its pathetic state.

In an effort to better protect U.S. consumers, on September 27, 2007,
President George W. Bush signed into law the Food and Drug
Administration Amendments Act of 2007 (FDAAA), which aims to deliver
expanded authority to the U.S. Food and Drug Administration (FDA) to
govern the safety of the U.S. food and drug supply. A key element of
that legislation is that it requires more comprehensive, objective
post-market safety and risk-mitigation activities from pharmaceutical,
biotech, and medical device companies than has historically been required.

The collection of information relating to Adverse Events (AEs) is an
integral part of understanding the safety of a product throughout its
marketed life cycle. The FDA has stated its commitment to maximizing
the public health benefit of collecting and reporting serious and
non-serious AEs. Central to addressing this question is determining
the number and type of safety concerns discovered by AE collection,
the age of products at the time safety concerns are detected by AE
collection and the types of actions that are subsequently taken to
protect patient safety. As part of this effort, the FDA held a public
workshop on January 29, 2008 and also solicitedpublic comments to be
included in the docket.

Again, last January, when the FDA solicited public comments on
post-market analysis, I offered my own comments to the FDA, among them
were the following:

Because most patients with type 2 diabetes mellitus typically suffer
from a relative rather than an absolute deficiency of insulin, and
because a majority of patients with type 2 diabetes who use insulin
will use it for a significantly shorter duration, although the
evaluation of safety in this particular patient group should be
considered, it should not necessarily carry the same weight or
consideration in post-market safety and risk-mitigation activities
relative to patients with type 1 diabetes, especially with regards to
AEs.  This is particularly true when evaluating novel insulin
formulations, including variations by species, method of manufacture,
and genetic alterations when conducting post-market analysis. A
majority of clinical trials sponsored by insulin manufacturers have
recruited patients with type 1 and type 2 diabetes more or less
equally, in part, because of the significant market potential that
type 2 diabetes patients represent to industry.

However, the adverse event profile is profoundly different in each of
these groups (for example, the incidence of severe hypoglycemia is
almost 25 times higher in patients with type 1 vs. insulin-using type
2's); therefore, I believe the FDA's study design methodology has
effectively marginalized the collection of and the examination of AEs
in patients with type 1 diabetes mellitus, giving the appearance that
the overall risk of AEs for that particular patient group is smaller
than it is in reality.

Note that biosynthetic insulin has NEVER been subject to post-market
analysis for adverse events, even though a number of studies have
suggested it carries a higher rate of hypoglycemia without symptoms
than highly-purified animal-sourced insulin (pork, beef or combination
of pork and beef).  Ironically, synthetic insulin relies almost
exclusively on animal-sources for the agar that is used to culture the
hormone.

The bottom line is that while you are entitled to disagree on the
petition, I think you were a bit quick to condemn it before knowing
what the guidance actually says.  It is for these reasons (and more)
that I am supporting the petition.

Regards,
Scott Strumello





--- In nathanfaustmantrials@yahoogroups.com, Joshua Levy
<joshua2levy@...> wrote:
>
>
> I don't agree with your petition at all!
>
> First, the letter only applies to medicines that treat type-2
diabetes, so it will not slow down a cure for type-1 at all.
>
> Second, there have been a couple of drugs which actually got
approved for type-2 diabetics which had bad side effects in terms of
raising the chance of heart attacks.  The FDA reacted to these
problems by fixing their process: by requiring the drug companies to
do testing focused specifically at heart risks.  That is the right
thing to do!
>
> Prior to these new regulations, type-2 diabetic drugs could be
approved after clinical trials lasting only 3-6 months.  That's nuts!
  Those drugs are typically taken for years (maybe even decades).
Requiring them to be tested for a year is long over due.  The extra
time is required to get a statistically valid sample of heart risk.
>
> If we want a safe drug supply in this country, the FDA should go
farther, and require post-approval  (called "postmarket") safety
testing lasting as long a the expected use of the drug.  That is basic
common sense.  That would shake out a lot of safety issues before
people got hurt, without slowing down drug approvals.  But in the mean
time, the FDA's rule change is a good step in the right direction.  In
my opinion.
>
> Joshua Levy
>
>
>
>
> ________________________________
> From: Bernard Farrell <bernard.farrell@...>
> To: nathanfaustmantrials@yahoogroups.com
> Sent: Monday, January 5, 2009 8:15:01 PM
> Subject: [nathanfaustmantrials] Ask FDA to better serve the needs of
diabetes patients
>
>
> A large group of us has started an online petition to the FDA.
>
> We're asking them to remove new requirements they recently placed on
> diabetes drugs.
>
> Please sign. The petition is at: http://HealTheFDA. com/
>
> If you want more details, I've posted them on my blog at
> http://is.gd/ eEMB.
>

A large group of us has started an online petition to the FDA.

We're asking them to remove new requirements they recently placed on
diabetes drugs.

Please sign. The petition is at: http://HealTheFDA.com/

If you want more details, I've posted them on my blog at
http://is.gd/eEMB.

Hi Joshua

Thanks for your reply.

First up, Im not out to pooh pooh BCG ...actually Ive contributed
money to the cause and in doing so urge everyone and anyone who has a
heart to do so as well.

We need this trial to get the funding !
No We have to make sure we get the funding guys !!!!!


One comment to make other than that on this page below...look for

Genetics of BCG Induced Lupus in NOD Mice
http://www.jcu.edu.au/cgc/AutoimmunityResRep.html

I know you already said its not an issue with the other study that
found this, however I feel I should point these things out.
NOD mice are similar to sick autoimmune suffering people..as we have
immune systems genetically bred to go wrong as well.

I have confidence in Denise as Im sure she would already know about
these cases and about the BCG induced SLE in NOD mice.

Its my reckoning she thinks she has a dose or way of dosing as to
make this a non issue..in fact I really hope she really has.

I say it again we must all support this program..it is a first for so
many reasons..not least being the only direction in therapy that is
trying to rid the body of these destructive cells specifically
instead of destroying most of the immune system.

In fact Im going to put my hand in my pocket again for this cause and
yet again for Phase II

And as we all know most therapies do have some kind of side effect in
a small number.

When I was a teen everyone got the BCG no one got sick AFAIK..however
Im really sick now some 35 years later..its a  long time to say there
is any connection..and if BCG can fix it ...and there are always
risks to new treatments..Im willing to take another shot...Id be the
first in the queue !

Go Denise !





--- In nathanfaustmantrials@yahoogroups.com, Joshua Levy
<joshua2levy@...> wrote:
>
>
> I don't have enough time to write a full reply, but here are some
quick comments.
> My words in are blue, croma_clear1's words are in black.
>
>
>
>
> ________________________________
> From: croma_clear1 <jlcandrb@...>
> To: nathanfaustmantrials@yahoogroups.com
> Sent: Saturday, January 3, 2009 2:53:57 AM
> Subject: [nathanfaustmantrials] BCG Safety Record
>
>
> Ive just read documentation that lists BCG as the cause of
> Autoimmunity, Hepatitis
> several cases in fact, they include Lupus, Reiters
>
> Reiters
> http://linkinghub. elsevier. com/retrieve/ pii/S08968411009 04943
> Reports on  1 case
> of Reiters after BCG treatment.  No data at all suggests that
Reiters is
> more common after BCG treatment that without BCG treatment.  For a
drug
> like BCG, which has been given to 100s of millions of people, you
would
> expect some people to get Reiters after it, just because you are
giving
> it to so many people.
>
> Lupus
> http://www.annals. edu.sg/pdfSep02/ TanHH.pdf
> Reports on between 1 and 4 cases of Lupus after BCG treatment.  No
data at all suggests that Lupus is more common after BCG treatment
that without BCG treatment.  For a drug like BCG, which has been
given to 100s of millions of people, you would expect some people to
get Lupus after it, just because you are giving it to so many people.
>
> Hepatitis
> http://www3. interscience. wiley.com/ journal/11267939 5/abstract?
> CRETRY=1&SRETRY= 0
> Reports on  a single hepatitis  case  which occured 1 1/2 years
after BCG treatment, in someone who already had bladder cancer.  No
data at all suggests that hepatitis is
> more common after BCG treatment that without BCG treatment.  For a
drug
> like BCG, which has been given to 100s of millions of people, you
would
> expect some people to get hepatitis after it, just because you are
giving
> it to so many people.
>
> And this link shows a whole heap of adverse reactions
> http://www.whale. to/vaccines/ bcg.html
> This is a site full of quack vaccine-hater stuff.    If you see any
specific study there you want comments on, give me a more specific
link.  In the past when I have looked at this site, it has been a mix
pseudo-scientific crap, made up data,  fearmongering, and bad
statistics.
>
> Also read that NOD mice given BCG prevented diabetes but end up
with SLE
> http://www.pubmedce ntral.nih. gov/articlerende r.fcgi?artid=
1414944
> This is an  interesting study.  However, I think it is a mistake to
think that the BCG cause the SLE in these cases.  These were NOD
mice, which are genetically bred to have immunology problems!  It may
just be that the BCG kept them healthy long enough to get SLE, when
not giving the BCG caused them to die of type-1 diabetes before they
could get SLE.  If I have time, I'll read this study and give a more
complete answer.
>
> More
> http://www.jcu. edu.au/cgc/ AutoimmunityResR ep.html
> I don't see that this web page has anything to do with BCG causing
diseases.  It is all about genetic markers.
>
> I guess my point is..is BCG really safe?...I guess thats why there
IS a
> Phase 1 afterall.
> BCG is safe when used as a vaccine, and we know this because people
have done large scale studies that compared vaccinated to
unvaccinated people, to see relative health problems, and found the
BCG vaccinated people had no extra problems (and less TB).  This sort
of comparison study is how safety is measured, and none  of the
studies you listed above is this kind of comparison.
> Let me ask you a counter-question: is driving a car "really safe"?
Far more poeple die while driving than die from a BCG vaccination.
The difference is 100,000 to 1 or more (maybe even 10 million to 1).
Do you drive?
>
> In terms of safety testing, remember that Faustman's trial only
follows the patients for a year or two (someone can fill in the
details).  So it will catch bad side effects that happen quickly
(especially at the time of dosing), but not those that take years to
show up (if there are any).
>
> Joshua Levy
>  __
>

Ive just read documentation that lists BCG as the cause of
Autoimmunity,Hepatitis
several cases in fact, they include Lupus, Reiters

Reiters
http://linkinghub.elsevier.com/retrieve/pii/S0896841100904943

Lupus
http://www.annals.edu.sg/pdfSep02/TanHH.pdf

Hepatitis
http://www3.interscience.wiley.com/journal/112679395/abstract?
CRETRY=1&SRETRY=0

And this link shows a whole heap of adverse reactions
http://www.whale.to/vaccines/bcg.html

Also read that NOD mice given BCG prevented diabetes but end up with SLE
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1414944

More
http://www.jcu.edu.au/cgc/AutoimmunityResRep.html

I guess my point is..is BCG really safe?...I guess thats why there IS a
Phase 1 afterall.

Looks like Dr. Faustman has a new web site at www.faustmanlab.org.
It's still the same web address, but there's a new look, more content
and you can give online to support her work.

-Marvin