Re: Helicobacter pylori

[mozley@darius.pet.upenn.edu (P. David Mozley, M.D.)]

>     Why do you need to introduce C-14 into a patient when the current
>     hematological test is sufficient and accurate?

It is not clear that any hematological test is partially sufficient or
occaisionally accurate.

The hematological tests (of the host immune system) aimed at detecting a
response by the host to the pathogen may not be useful in conventional
medical settings.  Antibody levels to H. pylori are not helpful because
they do not reflect the current state of the patient. They only show that
once, there was enough colonization to provoke a systemic response.  One
can not distinquish between an acute infection and the historical remnants
of a prior one, or differentiate between a cancer and a classic ulcer
causing dyspepsia.

Some awlfully smart and well meaning folks are very enthusiastic about this
test.  It may be that a more erhudite, and perhaps compelling, rational for
the C-14 urea breath test was presented to the FDA at its hearings in
Washington on 22 Feb 96.  Perhaps some of those folks who were there could
clue us in as to what went down. It's also clear that the FDA has held up
its approval for some time.  It would be good to learn what their real
objection is, since the idea that all the radioactivity was not recovered
during the biodistribution studies is hard to believe.

Please blame my employer if you don't like what I said.

mozley@darius.pet.upenn.edu