Allies Voice: Deconstructing doubt in Dr. Faustman's Cure
Funny how we perceive doctors to know it all until we start questioning what it is we think they know. In all fairness, I don't expect an internist to be able to explain the research of a dedicated scientist - but a comment one doctor made to me a few weeks ago launched me on an investigation.
When discussing my excitement about Dr. Faustman's research to cure Type 1 diabetes with BCG -- the doctor (who was born, raised and trained in India) said to me, "Children are vaccinated for TB in India with BCG. Type 1 diabetes exists in India. Why would you think this research will work?"
Good point, doc. So with itching curiosity -- I go straight to the source, Dr. Denise Faustman. I propose the question my faithless internist passed to me in our debate. I do not perceive these questions as brick walls. In fact, these types of questions help me deconstruct the confusion that breeds misunderstanding of the Faustman cure.
Very clever - Dr. Faustman explains that the dose used to vaccinate children from tuberculosis is equivalent to trying to treat elevated blood glucose with 1 unit of insulin, one time. It's not expected to be effective at all. However, statistically speaking - the incidence of Type 1 diabetes in the US is higher than in countries where they vaccinate for TB. Here in the US we do not vaccinate for TB. Coincidence?
Think about it: the TB vaccination is a preventative measure - a weak dose to prevent a speculative illness. The cure for chronic, long-standing diabetes is like performing a piecemeal extermination. You are segregating a specific class of T-cells and then retraining the immune system to not attack itself. It's actually more sophisticated but that's the Cliff's Notes version. If it was so simple -- it would've been done decades ago!
To follow-up from my appointment on Tuesday I would like to ensure everybody that Phase I for human trials to cure Type 1 diabetes is moving along with grace and grit. Dr. Faustman and her research team are carefully calculating every step along the way. Rest assured they are playing by the FDA rules. No harm, no foul and certainty for the pass to Phase 2.
Phase I began in December 2007. It will establish a safety threshold for dosing of BCG. Once this threshold is established -- Phase 2 will begin to trial for efficacy in ceasing the the attack on beta cells. Am I still excited? You bet! I've already booked my next date with Dr. Faustman's Lab: March 31st, 2009. Happy Birthday Allie 
When tuberculosis was still a major disease in the Western world, tuberculosis was also a major diabetic complication. With the arrival of BCG in 1948, many diabetics were treated with massive doses of BCG to cure their TB, but not a single case of diabetes remission was reported. How is this to be explained?
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From my understanding:
1.) There needs to be a "second arm" of treatment with a drug *in addition* to BCG to fully "cure" autoimmune (Type 1) diabetes.
2.) Full/partial regeneration of beta cells after the autoimmunity is stopped (assuming this will occur) seems to need euroglycemia (normal blood sugar levels) to be successful. It's a catch 22. From what I understand, it is likely that a temporary transplant and/or regenerating drugs will be needed for a cure. You can't just wake up one day and find that your pancreas has suddenly come back to life. That's not realistic.
3.)Type 1 is overall fairly rare. Especially back in the days of poor care when T1 diabetics usually were not able to or did not procreate. They also often died of infection. How many *TYPE 1 diabetics* actually survived TB and treatment at that time? What if the vast majority of cases were Type 2 diabetics, which has nothing to do with autoimmunity and the form of diabetes in question? There is little data to form an opinion if that is the case.
I support Faustman 100% (and have sent donations too), but I do have some concerns as well. I think that after hearing that a cure is "around the corner" for the past 24 years, this is normal.
1.) The needed second arm of treatment for a cure is not known or has not been released to the public.
2.) What if "resetting" the memory T-cells is NOT permanent in humans? Think about this...if we are still being exposed to the trigger, won't the disease occur again and again over time? Such as in the T1's who were given an experimental bone marrow transplant and complete immune system overhaul? They WERE technically cured...for a few months or so. Potentially, if the trigger has not been removed, re-setting the immune system is futile for a permanent cure. Ideally, the trigger would be a food protein for most cases, such as casein or gluten, which can easily be removed from the diet.
All current evidence suggests that autoimmune diabetes begins in the gut, and may very well be linked to specific food proteins. An additional trigger, such as a virus (and other factors like a lack of Omega 3), seem to be needed as well.
So a final cure may look like this:
1.) Immune modulating compounds or treatments.
2.) Temporary/Non-temporary transplant/regenerating drugs for some patients.
3.) Permanent removal of the trigger (if possible) via diet and/or antibiotics/vaccines/antivirals.
If the main cause is trigger exposure via the "leaky gut", then closing those gaps may prevent the trigger from causing the disease. Then the trigger will not affect T1's and cause disease, such as in the normal population. Probiotics and Vitamin D have been shown to help with the "leaky gut". Research is big in this area.
The point is, Faustman is not going to cure diabetes overnight, IMHO. That would be nice, but this is going to be more complicated than that. But I have hope that her work part of the puzzle.
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I quite agree that we don't get very far just by modulating or diminishing the autoimmune response, since of the hundreds of thousands of type 1 diabetics who have severely suppressed immune symptoms from being on immuno-suppressive drugs or from having AIDS, not a one has ever been cured, nor even shown any improvement in blood sugar control. In fact, with patients on immunosuppressive drugs, the opposite is true, and blood sugar control becomes more difficult rather than less.
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I agree. This has been studied. Now, this patient below probably has Type 1B/Idiopathic diabetes, which is not autoimmune and the need for insulin comes and goes (it is usually found in blacks and Asians).
http://www.ncbi.nlm.nih.gov/pubmed/15660742?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
http://www.ncbi.nlm.nih.gov/pubmed/8498773?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_Discovery_RA&linkpos=2&log$=relatedarticles&dbfrom=pubmed
I couldn't find anything else on Pub Med.
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Thought you might be interested in what we are trying to do over at CWD
http://forums.childrenwithdiabetes.com/showthread.php?t=15353
There are several discussions going on.
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Why does Faustman use Freund's Adjuvant as a device to modulate the immune response in her mice experiments? Freund's Adjuvent is so extremely toxic that it has never been approved for use in humans and never will be, so why does Faustman make her experiments less relevant to human patients by using that poison in the experiments, especially when there are so many immune modulating drugs available which are approved for human use?
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She's actually using BCG, rather than Freund's Adjuvent. It is the chosen treatment going through " human trials" for that very reason - to see how much is needed to be effective and safe.
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I am aware that BCG is the primary immunomodulator used in the human trials, but I was wondering why all the basic experimental work Faustman did with mice was done using Freund's Adjuvant?
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Does anyone know what the progress is with the clinical trials? They have been going on for a few months now and no one is speaking about anything.I would think there would be some news as to if the bcg is having any affect at all on the T cells,or do they have to wait to release that info?
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