RE: [IP] RE: Humalog- was Joel Krueger
Maria [mailto:email @ redacted] wrote:
> Novolog is FDA-approved for pump use, but Humalog is not. This means
> that Novolog has been proven safe and effective for use in pumps.
Actually, all they had to do was demonstrate that it's essentially
equivalent to Regular.
> also means that Lilly hasn't proven to the FDA that Humalog
> is safe and
> effective for use in pumps.
No, it only means Lilly hasn't filed an application for approval. FDA may
suggest that a manufacturer apply for such approval, but they cannot
pro-actively approve a drug or device.
> Admittedly, a heck of a lot of
> people (my
> daughter included) are alive today because they are using Humalog in
> their pumps. So you'd think it would be a no-brainer for
> Lilly to just
> PROVE that Humalog works for pumps, and apply for FDA
> approval for this
> use. But they haven't done this.
They haven't because the process is expensive and, as you demonstrate in
this paragraph, they don't need to. Why spend the time and money in this
case? Maybe that's why Novolog is more expensive than Humalog.
> Unfortunately, this
> forces Humalog
> pumpers to play a guessing game - how long can it last in the pump?
This is not something that is part of the clinical testing used to approve a
device or substance. Clinical trials have to demonstrate three things:
efficacy, short term safety, and minimum effective dose.
> How about on a hot day? And we have to do the experiments on
> and our children, ad hoc, because Lilly hasn't done the work
> (at least,
> not that we can tell).
But this is true for everyone who uses insulin regardless of method of
delivery. Each person's needs are unique.
> I actually called Lilly recently and the
> technical rep told me that they don't recommend using the
> insulin over
> 86 degrees F. Well, does this mean they've tested it above 86 and it
> went bad, or does it just mean they never tested it above 86? No way
> to tell, unfortunately.
It's probably more a matter of CYA than anything else. Since they cannot
control the use or storage conditions, all they can to is make
recommendations. But no one is going to stop using insulin if the
temperature goes over 86 degrees. Even in cold weather, the tubing next to
one's skin is going to warm the insulin to well over that temperature before
it is infused.
> However, right now Lilly has diluent that is approved for use with
> Humalog (and the diluent is free!), but Novolog doesn't have
According to Novo, the inert portions of Novolog and Humalog are identical.
The difference is the specific peptide that is altered (I don't recall the
details but I can look it up if need be).
> So, we would be using an unapproved something either way. Probably
> both are perfectly fine, but gosh I wish the manufacturers had
> well-controlled research to prove it to me. Unfortunately,
> this is the
> case with a LOT of pediatric medicine - last I heard, at
> least half of
> the drugs used for children have never been tested in children (with
> the result that every child using these "untested" drugs is,
> in fact, a
> guinea pig.....).
If someone is truly a "guinea pig", then that means that they are part of a
trial for an IND (investigational new drug) which includes off label use of
an established drug and they are not standard of care. If this is the case,
then the parents or guardians will have had to sign an informed consent
document. If this is not done, then either the drug is being used according
to an established protocol and it's not research or the physician is being
unethical in giving the drug and is liable for disciplinary action under
both U. S. federal law and international law.
In the case of Humalog and Novolog the use of these hormones follows
established standards of care and FDA approval is unnecessary for their use,
and approval impacts *only* the marketing and sales.
James Handsfield, PhD, MPH
Centers for Disease Control and Prevention
email @ redacted
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