I can't speak to the toxicity of the dosage used in the trial mice. When I spoke
with Dr. Faustman at some length (see DiabetesDaily interview) she mentioned
that CFA was toxic to humans. This was in the context of discussing whether a
single dose of BCG would 'cure' diabetes. She said that in mice CFA seems to be
a permanent cure with a single dose. But to develop the same for humans would
require new drug development.

I suspect (not from talking with her) that if BCG works, we'll end up taking a
dose of BCG on a regular basis in place of insulin. But we won't need to test
our blood sugar. I'd inject daily if I knew that highs and lows were gone. That
would be a huge win for me.

Bernard
http://blog.bernardfarrell.com/


--- In nathanfaustmantrials@yahoogroups.com, "Ivan Roseland" <iroseland@...>
wrote:
>
> --- In nathanfaustmantrials@yahoogroups.com, Joshua Levy <joshua2levy@> wrote:
> >
> >
> > Faustman's new lab web page contains the following quote:
> >
> > In research published in 2001 in the Journal of Clinical Investigation and
in 2003 in Science,
> > Dr. Faustman and colleagues used a brief, non-toxic treatment to induce
> > TNF-a in end-stage diabetic mice and permanently eliminate their
> > disease.
> > (from http://www.faustmanlab.org/research/research.html)
> > But this is an obvious mistake: Faustman's treatment described in the paper
uses CFA, which is highly toxic to people and animals.
> >
> > Take a look at the 2001 paper. The abstract clearly says:
> >
> > Hyperglycemic NOD mice were treated with CFA to induce TNF-� expression
> > and were exposed to functional complexes of MHC class I molecules and
> > antigenic peptides either by repeated injection of MHC class I matched
> > splenocytes or by transplantation of islets from nonautoimmune donors.
> > (from http://www.jci.org/articles/view/12335)
> >
> > And CFA (Complete Freud's Adjuvant) is well known to be toxic. So toxic
that it can not be used in people at all, and is discouraged even in animals, as
show here:
> >
> > (CFA) is quite toxic and cannot be used in humans.
> > (from
http://books.google.com/books?id=TFoIXMe-UEEC&pg=PA403&lpg=PA403&dq=complete+Fre\
und%27s+adjuvant+CFA+safety&source=web&ots=dYXKq2PcQ-&sig=zrlavn3Lmahle2DArr02aE\
1_Ib8&hl=en&sa=X&oi=book_result&resnum=10&ct=result)
> > and also
> >
> > The undesirable side effects attributed to CFA use include increased pain
and suffering and morbidity in inoculated test animals
> > (from http://www.vcu.edu/oehs/chemical/biosafe/CFAinfo.pdf)
> > and here:
> >
> > The
> > best example of this is complete Freund's adjuvant (CFA). While it
> > remains the gold standard in terms of adjuvant potency, its extreme
> > reactogenicity and toxicity precludes its use in human vaccines, and
> > there have been discussions of banning CFA even in veterinary vaccines.
> > (from
http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/New-A\
ge-Vaccine-Adjuvants-Friend-or-Foe/ArticleStandard/Article/detail/444996)
> >
> > So it sounds like the description of Faustman's treatment as "non-toxic', as
is done in her lab's web site, is a mistake. The experiment used CFA, which is
toxic. Or is there something I'm missing? Does someone know why Faustman's
web page refers to this treatment as non-toxic? Is there something about her
formulation or dosing that makes it safe? (This question has nothing to do with
the safety of Faustman's current clincial trial, because that trial uses BCG.
From a safety point of view, BCG and CFA are quite different.)
> >
> > Joshua Levy
> >
>
>
> I think by non-toxic they meant a doseage that was not known to cause the
toxic side effects... Also, she has made a point of telling folks that part of
the research is to find a human tolerable replacement for CFA.
>
> Ivan