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I have had a chance to visit with Dr. Faustman. Here is some information I gathered that might be helpful. The FDA did limit Faustman/Nathan to two doses in the Phase I trial. MGH had originally wanted to do 6 doses but the FDA did not allow that for safety reasons. The Faustman lab and the MGH are experienced at dosing trials and although the protocols are approved within Harvard it is too early to speculate what the FDA will advise for Phase II. All need to wait to see what Faustman/MGH want and what the FDA will allow. Remember that in general the FDA is ONLY interested in SAFETY so it is likely that they will come at the Phase II trial from the safety view point. Faustman/MGH will advocate for a therapeutic outcome. Lastly, keep in mind that the two doses of BCG for multiple sclerosis (Phase II trials) showed amazing effects when patients are followed out 5 years so the BCG drug can have long lasting therapeutic effects in autoimmunity that are now are allowing Phase III testing for that disease. The BCG scientific community has had and does have interactive scientific exchange trying to use this cheap drug and the progress in humans with autoimmunity is progressing very rapidly. If Faustman needs help then I am sure Faustman will work with the supportive lay community for help. Bruce: Thank you for your comment to our Newsletter #8 – “The Skinny on Faustman’s Phase II”. Especially relevant is your statement that the FDA limited Phase I to 2 doses of BCG instead what was requested by the Faustman Lab, which was 6. Many people still think the FDA simply approves what the researcher requests. This is not the case here. You mention that “…the FDA is only interested in safety…” As you probably guessed, we don’t believe the FDA limited Phase I to two doses because of safety. In the last 2 newsletters we’ve proven that BCG has been used at 2 doses for TB and multiple doses for Bladder Cancer with no negative effects in the long term. “The Faustman lab and the MGH are experienced at dosing trials … and the protocols are approved within Harvard …” Yes, we wonder why the FDA doesn’t recognize this fact. You said also “… keep in mind that the two doses of BCG for multiple sclerosis (Phase II trials) showed amazing effects when patients are followed out 5 years …) We feel this study and Dr. Faustman’s can’t readily be compared because the MS study used interferon-β-1a before BCG. We can’t assume the combined effects of two compounds would be the same as BCG alone. Also even though both diseases are auto-immune, both diseases could require different dosages/frequencies. You can see the MS study here: http://www.neurology.org/content/early/2013/12/04/01.wnl.0000438216.93319.ab.abstract The results of this study was very minor – a reduction of a small number of lesions. Not a single complete reversal… just a slight reduction of the MS progression. Dr. Faustman’s research aims to reverse type 1 diabetes completely…not just reduce insulin by 1 unit. The general public wants a cure in the shortest period of time. Why not give a therapeutic dose i.e. several successive doses to tolerance to begin with? Why wait 5 years? Surely a cure is more important than going over the safety issue again. Many drugs that are proven safe are often fast-tracked for another condition at a fraction of the cost. Again thank-you for those very interesting facts, but we just don’t agree with you that the FDA is operating with the public interest as its primary purpose. We believe that they are using their indemnity as a smoke-screen forcing bad methodology in research, in order that cures NOT be found. They should be utterly ashamed of themselves for not following scientific precedents and for sloppy scientific reasoning. The Editors, Hdiabetes.com
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