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RE: [IP] ridiculous why we are not able to use artificial pancreas



I also have hope. I think the FDA is being more cautious these days because
of all the screw ups they have made. This goes back to the 1950 DES scandal
the effects of which women are still living with, thru the drugs that have
been approved only to be recalled a year or two later when thet have serious
or fatal side effects. Here are some new devices that have great potential
but also great potential to be fatal so they need to make sure they have all
their ducks in a row.

-----Original Message-----
From: email @ redacted
[mailto:email @ redacted] On Behalf Of John S Wilkinson
Sent: Monday, November 28, 2011 10:21 AM
To: email @ redacted
Subject: RE: [IP] ridiculous why we are not able to use artificial pancreas

I agree with you somewhat. I still have hope , If we could put a man on the
moon in 10 years, We should be able to create a artificial pancreas. If the
same amount of resources were used.


John S Wilkinson, Rome, NY
"A  veteran  is someone who, at one point in his or her life, wrote a blank
check made payable to The 'United States of America', amount of up to and
including their life." (Author unknown)

"A government big enough to give you everything you want is a government big
enough to take from you everything you have," Gerald R. Ford, August 12,
1974.

-----Original Message-----
From: email @ redacted
[mailto:email @ redacted] On Behalf Of
email @ redacted
Sent: Monday, November 28, 2011 10:07 AM
To: email @ redacted
Subject: RE: [IP] rediculous why we are not able to use artificial pancreas

There is no proposed closed loop that eliminates the patient
That's not even a twinkle in Minimeds eye.  Every closed loop system that is
being proposed and is anywhere close to large scale human trials still
requires carb counting and patient input.  
That will remain until insulin that better matches the activity of insulin
from the pancreas.
 
With the current lag time and tail of the insulins on the market no CGMS
augmented system will ever be able to keep up with the BG spikes when you
eat.  

To summarize: the most accurate Sensor has been removed from the market and
the fastest insulin available lag endogenous insulin by an hour.  And the
FDA is slowing and encumbering the approval process for basic devices let
alone advanced devices 

Doesn't bode well for Closed loop of ANY kind in my lifetime.

It does however work well as a marketing message for Medtronic AND JDRF -
Helps to raise a TON of money for both.  
And it does a nice job of distracting from technology and research into a
true cure.  For example the immune response research currently being done 


-----Original Message-----
From: email @ redacted
[mailto:email @ redacted] On Behalf Of Stephen Golden
Sent: Monday, November 28, 2011 8:24 AM
To: email @ redacted
Subject: RE: [IP] rediculous why we are not able to use artificial pancreas

The problem is that with this system the patient is not controlling it
either. With an insulin pump and CGM you make the decisions. For example if
the CGM tell you your BG is 40 and you are feeling fine you know to test
before you bolus. If you have a totally closed loop system the potential is
that the system could adjust itself and over or underdose you. With a
totally closed loop system more safeguards are needed because you have
eliminated the human factore. 
.
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