Comment: the following asks some good questions. I'll add one more: the Oct.
18 FDA Public Health Advisory
(http://www.fda.gov/bbs/topics/NEWS/2001/NEW00774.html) fails to address the
need for sensitivity tests to establish efficacy of doxy for a particular
strain. Is there any basis for the FDA's (undocumented) implication that
doxy is as effective as cipro for all strains, contradicting the AMA
position? Please cc: [EMAIL PROTECTED] on any replies.
Forwarded from Jerry L. Mothershead [[EMAIL PROTECTED]] from [DailyBrief]
list:
Keep forgetting that there are a lot of non-medical types on this
list...just for clarification...up until the 18th of October, Cipro was the
only FDA approved drug for post-exposure prophylaxis for EXPOSURE (but not
necessarily infection with) anthrax. It was also the recommended FIRST LINE
medication for TREATMENT of active disease. In practicality, what this
means is that at the institutional level (e.g. OEP, the Military Services,
etc.) they cannot plan on widespread distribution of other medications for
post-exposure prophylaxis to anthrax, which would be called "off-label" use.
An individual physician COULD prescribe another medication for post-exposure
prophylaxis and/or for empiric treatment prior to identification of the
bug's sensitivity to various medications, but, again, in practicality, a
physician wouldn't do this unless there were clear reasons to avoid Cipro -
not just good medicine reasons, but also the ever-present legal ones...if he
uses another drug and the patient dies, he's going to have trouble
justifying his bucking of the recommendations in a lawsuit.
Now, on the 18th, without much fanfare, FDA released a press statement which
definitely states that it may be used for the TREATMENT of any form of
anthrax, and the release SEEMs to say that it can also be used for
post-exposure prophylaxis, which makes sense - if you can use it for the
disease, it only follows that you should be able to use it to prevent the
disease in the first place.
NOW...here is my dilemma on this, and if Jerry Hauer is on the list, maybe
he can explain the rationale to me...IF the FDA now approves doxy (in other
words, it is equal to Cipro), and signficant side effects are roughly
equivalent, AND the cost of doxy is so much cheaper than Cipro (doxy is now
generic, cipro and the other floxins are not), why is Secretary Thompson so
insistent on beating up on Bayer, rather than increasing the stockpiles of
doxy...even at 95 cents/pill for the Cipro, it is still 3-4 timew as
expensive as doxy...that is a lot of money that could be spent in other
areas of medical preparedness...I THINK I know what is going on here, but am
not sure...
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