I was only able to catch the first 20 minutes of today's TuD video with Dr. Faustman. What was the main takeaway from this session?
Did she say when it's expected that they'd reach the stage 3 clinical trials? What stage are they at now? Stage 1 or stage 2? Is the main obstacle money? Is the FDA delaying this science from proceeding? Are their any new risks to taking the vaccine that she talked about?
Anything important for me to know?
Thanks for any responses you post!
Well, I answered a few of my questions by looking at this web site. I'd still be interested in reading any comments of any of today's participants.
The big elephant in the room to me was why did it take 10 years and what 12 million dollars to run a Phase 1 trial on 6 (yes, six) people? The positive takeaway was that things shoud be starting to move a bit into Phase 2 where they'll be analyzing outcomes of different dosages on different folks, however, she still needs another 8 million dollars to reach the 25 million goal, so I'm not sure how quickly it will move forward. There don't appear to be any risks and BCG has a 100 year safety profile. FDA wasn't listed as an obstacle. No, she didn't duscuss when Phase 3 would be, though I had read that Phase 2 will take around 4-6 years. The thing that has me so baffled is the timetable of it all.
I don't think she said anything about a phase 3, they still need a few million dollars for phase 2 which will have more people and candidates for phase two are being picked out I think. I don't know if she mentioned anything about the FDA approval because it all has to be approved I assume.
Some interesting points were that Dr. Faustman believes that vaccination for early childhood diseases may play a role in some autoimmune conditions like type 1.
As for the safety I still have questions about this because although bcg seems to be very safe, we still don't know how giving possibly larger, more frequent doses of a vaccine will affect each person.
There gets to be a point as one advances in age that you realize the odds of seeing some of the pharma-techno-marvels on the horizon may be beyond your personal horizon...
So, is there any way to see this interview? It looks like it was just done in real-time. I can't find it posted in the video section of the 'media' area.
Jim--I tend to agree with you that something is off. As T1s, I think we tend to give the benefit of the doubt to anything that could potentially alleviate this burden from us, and much of the science behind elevating TNF to restore normal T-cell function seems plausible, so what we're left to do in the meantime is to keep holding on to hope that what many of us see as "off" within the Faustmann front is just a matter of her personality, and we're hoping it's not actually her science that's off. But man, I just grapple with the fact that while I want her research to be the holy grail, realistically, it could just be a wise woman making a career out of research that never substantiates to anything clinically. During the interview, Dr. Faustmann stated that what makes her organiztion different is that they don't criticize others' research and what will bring a cure, then in the next sentence she put a derogatory spin on it and said something to the effect of, "So that means if you think 'wrapping beta cells in a baggie' is going to bring the cure (ie encapsulation) then you're free to have that viewpoint." I agree, something seems odd, whether it be what seems to be the grossly drawn-out timetable or the quirks of a researcher, I'm not sure. All we can is hope that one of the several half dozen or so practical cure possibilities in the pipeline pans out, and what a jackpot it would be if more than one of them do...having some options around this would be divine!
