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Re: [IP] Re: Humalog

FDA approval is required to ensure that any drug (or food) is reasonably safe,
and that risks associated with the drug are known and documented for the
medical profession.

In most cases, the labeling issue is just that.  FDA approvals (or lack
thereof) means that no clinical testing results for that particular use have
been submitted to the FDA.  It does not mean the drug cannot be used for
another purpose -- in fact, subsequent studies often find that drugs have uses
beyond what they were initially tested for -- I think use of ACE inhibitors to
stop the progression of kidney problems for people with microalbumin is a case
in point, as this class of drugs were initially tested for lowering blood
pressure, not kidney preservation.  In the case of Humalog, the inital
clinical testing results that were prepared to get FDA approval were done on
adults, and if I recall correctly, I don't believe the clinical testing was
even done on adults with diabetes, but Eli Lilly Co. presented sufficient test
results showing the impact on blood glucose levels to attain FDA approval for
the new formulation.

Date: Wed, 14 May 2003 10:55:28 -0700 (PDT)
From: gail d <email @ redacted>
Subject: Re: [IP] Re: Humalog

> It is similar to Paxil (an SSRI anti-depressant) being
> used in children to treat depression, or Risperdol (an
> anti-psychotic used to treat schizophrenia and other
> neurological disorders such as autism).  Just because
> the label doesn't INCLUDE children, it can STILL BE
> USED to treat children.
> Same as Humalog.  Just because it doesn't list
> Pump-use on the label, doesn't meant it CANNOT be used
> in a pump.
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