I'm looking at the link you provided below, and I noticed something important to realize....
Quoting the link:
3. What must be accomplished before clinical trials can
begin?
The immunomodulation treatment that was effective in the animal model for type 1 diabetes
can be safely adapted for use in humans. However, the TNF-alpha needed for treatment is
not available in the United States at this time. Production is costly, and support is
needed to pay for its manufacture. An adequate supply of this is neeeded for the
preclinical and clinical trials.... (there's more, but I didn't copy it all.)
Obviously, this was a while ago, and a lot has changed with the
research. The trials will be using BCG to increase naturally occurring
TNF alpha in the body as opposed to trying to manufacture and
administer TNF alpha directly. I'm sure just this change alone added
time to the process of getting the trials underway. This is a good
change because it's an inexpensive drug as opposed to trying to use
something that would be cost prohibitive, and may not have ever made it
to a trial phase.
Also, don't forget the automated blood assay that has been challenging
and time consuming thus far. From the latest update from the lab, the
assay is moving along well, and they are anticipating starting phase
one in early 2008. They've been saying that timeframe for a while
now, so I'm personally optimistic that this really will happen soon.
Another thing the link you posted says:
4. When will clinical trials begin?
If all the preliminary work goes smoothly, clinical trials may begin in 2003 or possibly
earlier.
When
you posted your quote, you left off the, "if all the preliminary work
goes smoothly" part. The assay has been time consuming, like I said.
It's a very important piece. Funding has arrived slowly in the lab,
and they haven't been fully funded yet. As they meet milestones, they
are receiving funding from Iacocca Foundation. Other sources of
funding send money to her directly through Mass General's Cure Diabetes
Now fund. All this takes TIME.
If anyone wants this research to commence, it's ME. I have a 5 year
old daughter that's had this since she was 20 months old. She gets 6
shots most days. She hates diabetes, and tells me regularly. It
breaks my heart when she's sitting before me, hands shaking, crying
because she's ravenous due to being low, and I've already treated her,
and she has to wait. Or when she's really high, and can't run anymore
on the soccer field, so she lies on my lap on the sideline. I had
gestational diabetes and had to take insulin with both my pregnancies,
so I personally know what it feels like to be high and low. I
personally understand what the symptoms feel like, and I die a little
inside every time I witness my little girl suffering. She just started
kindergarten this year, and preparation for school has been lengthy,
time consuming, and difficult. I'm on the phone every single day.
After care won't give glucagon, so we can't feel safe leaving her
there, thus creating a hardship for us. To see a picture of her when
she was 3 years old with Dr. Faustman, go to www.bravedave.org , and read her story.
In a nutshell - this whole life with diabetes sucks. I get that.
Anyone interested in reading this yahoo group GETS THAT. We all really
GET IT. We want the cure now too. You're not alone in your sentiment.
However, don't rush the most promising research out there to trials
before they are absolutely ready just because life with diabetes
sucks. Turn that anger/sadness/desperation, etc. into something more
constructive, like spreading the word about it. Ask Dr. Faustman or
one of her representatives to explain what they are doing. GO TO HER
LAB, like so many of us have, and SEE FOR YOURSELF. I can tell you,
you would be uplifted to see and hear what's happening there.
I'd rather wait a little longer, and the cure be much closer, than to
rush to the trials, and fail. I remember reading a post that Sue Root
wrote reminding everyone that even with phase 1, we're not going to see
cures yet. We should see lots of positive data that tells them how to
run phase 2, which I'm hoping is where we'll see dramatic results that
will help our loved ones see an end. I hope I don't see posts that
say, "why aren't the first 40 people being cured???" That's NOT what
is expected. We all need to remember that.
What I always say to folks that help me fundraise.... let's make it so
one day my little girl, and all those suffering with this disease can
say, "I used to have diabetes."
Hopeful for a cure,
Stacy Lavery
Team Maryland State Captain, JLN Campaign
Nathan/Faustman Trials Yahoo Group Moderator
--- In nathanfaustmantrials@yahoogroups.com, "rn_hyatt" <rn_hyatt@...> wrote:
>
> Well, here I am again asking for any and all updates from the Faustman
> lab. I can't believe what started out in 2001 has yet to see the
> clinic. Will this work be forever pushed into the future?
> For a clinical trial that was slated to begin in 2003, the outlook is
> pretty bleak.
> I have included a link to the old MGH website that states "clinical
> trials will begin in 2003 or possibly sooner"! Of course that didn't
> happen. I also have a email from Marc Davino stating trials would
> happen in 2006!
> After 17 years with this monster, I am beginning to feel like I am
> waiting for something that will never come.
>
> http://web.archive.org/web/20040120204516/www.massgeneral.org/newsstori
> es/db_questions.htm
>