Discussion in 'Parents of Children with Type 1' started by happyearthgirl, Jun 25, 2011.
I truly love you all. This thread just gave me hope-something I did not *really* have.
Same for me...Still trying to decide if that's a good thing or a bad thing:cwds:
And one does wonder if JDRF will fund her now
Yes...having our hopes up could lead to painful disappointments. Or maybe, just maybe, they are on to something.:cwds:
Oh, I don't really wonder.
LOL, we can only "hope".
Well, friends, I think that any risky research without a major payoff for a company will be privately funded. But that's ok, because then we can direct funding to the projects we care about and have immediate impact. If you can't change the system, you figure out a way to do what needs to be done anyway.
I love the link Lisa posted, because Dr. Faustman does such a good job explaining things. What I found most fascinating was how many times they took the blood of the people in the clinical trial and that the patients were so dedicated, they never missed one blood draw -- not one person missed one draw! And no one else (that I'm aware of) measures the bad T cells that cause diabetes directly. Faustman spent years IDing these cells and perfecting the isolation of them. It was so time consuming, that they had to develop essentially a robot to speed it up, so they could do these types of clinical trials. So, they've been following the bad T cells in diabetics and non-diabetics (with no autoimmune disease) for years, so they can carefully follow any response to experimental treatments.
And my verbose way of trying to explain why the way that people carry out research is so important is really underscored here. Besides asking the right questions from each experiment and then following the next logical step in the progression, meticulous work makes a huge difference. Even in the mouse studies, her lab people came in and tested the BG of every single mouse twice a day and gave them injections of insulin to keep them in range. When people went to replicate Faustman's mouse studies, they weren't as careful and though they still got a decent cure rate, it wasn't as high as hers. BG control made a huge difference in outcome.
Not all research is the same -- not just the concepts and design of the study, but also how it's carried out -- attention to detail and careful work are both so important.
I was thinking about this today regarding fundraising, and really, I don't think funding is the issue here. I'm guessing it's not cost that's the issue, it's just a matter of doing the work, and taking the time.
Which leaves me with nothing to do but twiddle my thumbs. I would like to rush things along as much to prove it can't work if it won't as to get to a semi-cure if it can. Uncertainty is not my happy place!
That was a 1999 study using newly diagnosed with just one vaccination. Dr. Faustman did two vaccinations with patients 15 years out with type 1 within a 20 week period. Imagine the increased sophistication in research that occurs in 11 years! I don't think we can use this to debunk Dr. Faustman.
It's my understanding that she has less than half of the money she needs ... at least that was the case prior to the latest release of information. Fundraising, if you support her research is vital. I know that I'm writing her another check
Funding is definitely an issue for Faustman.
Thank you so very very much for your thorough and thoughtful posts. There is nothing "verbose" or "boring to tears" about them.
I had read the quick blurbs from the Faustman update and the news reports but came straight to CWD, hoping specifically to get your perspective on the news.
Many many thanks.
Really? I totally believe you, but that does surprise me. I know labs and staffs take funding, but I would have thought this would be a pretty cheap kind of study to do. Shows how much I know.
I'll spread the word and, as DR says, put one of the kids on Ebay to see if we can contribute too. . . I think it's pretty clear that for the sake of cancer and autoimmune research this is probably a study that needs to reach a conclusion of one kind or another, hopefully sooner rather than later.
Does anyone know how much she needs to do what? What kind of final price tag on the whole kit and kaboodle?
Rella is a terrific "translator" but not so much a pushy self-promoter... Here is a link the the website she made to promote Faustman's work and to encourage all of us to support her research.
Yeah, JDRF refused to fund her, and some JDRF-affiliated scientists went out of their way to publically discredit her. She's had trouble with funding ever since.
This type of research takes a lot of people -- Faustman has lab techs, graduate students and postdocs -- lots of them. But the real cost is in FDA regulatory costs and trials -- cost for Phase II -- approximately $25M. Phase III -- multi-center clinical trials -- is likely to be four times that much. Just the work to get the assay to sort and count out the bad T cells and the development of the robot and Phase I -- $10M. That's why pharmas usually do this these trials, instead of individual research groups. And these costs are for a generic drug -- already on the market. Development of a new drug, which is really what Faustman needs to do for permanent remission of type 1 -- $1 Billion -- and 20 years.
This only addresses part of it, but read this: http://www.helpcurechildhooddiabetes.org/FAQ.html
I decided to edit and remove this post, because it isn't productive towards this discussion.
I was aware that there was bad blood there with JDRF, but since I'm such a huge nonfan of JDRF I thought I'd keep my comments here isolated to Faustman.
I did not realize there was an active discrediting campaign and efforts to discourage contributions.
I still have to say I don't understand the whole process.
In an unregulated country, wouldn't Faustman simply have loaded up a syringe with a boatload of the vaccine and given a shot to the first T1 to volunteer every day for a week? I understand that eventually we're looking for a more directly targeting therapy, but right now the big question is "will large and frequent doses of the drug we've got make T1s need less or no insulin?", it seems that question could be answered pretty easily and cheaply in a nation with no laws regarding medicine use.
So, why does it have to be this difficult to answer just the basic questions? What is the regulation designed to protect? The test subjects or the public who will use the therapy? Seriously, we're talking about millions if it doesn't work and a billion if it does? If it takes a billion dollars to cure diabetes, so be it. But if it really takes $1.75 to cure diabetes and nearly a billion more to make the FDA happy while they're doing it, that seems absolutely insane to me. That can't be right. I mean, I'm totally fringe so I'll believe the FDA killed Kennedy if you buy me a few beers, but this seems too much. What am I missing?
We all need to think about why the FDA has such a process. The few times the USA has had a scientist misrepresent or at least from the volunteers viewpoint misrepresent their study ends in a huge, huge law suit usually followed by even more regulations. It is not always bad to slow study/research down, it just means many good people and good studies are slowed down due to a few bad apples or a few bad unexpected outcomes. The costs to do a large study over many years to show that a drug/procedure works for most patients without a bad side effect 10 years later is huge. The logistics are major for any widespread study. We are a big country and with size comes another layer of regulations and delays, but even the simplest scientific inquiry takes time and many many subjects.If you just start out doing a study and the first patient drops dead that first patient will be very unhappy even if it turns out he was the fluke thus as a scientist you need to dot your eyes and cross your t's:cwds:ali
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