JDRF Ad - Hypoglycemia

[Aaron Kowalski]

Hello Everyone,

It?s Aaron Kowalski from the JDRF. I?ve been reading the thread on the ad that we ran today in the NY Times and the Washington Post and wanted to provide some context and offer the opportunity for folks to ask questions of me. But, before getting into a detailed response, I want to say unequivocally that this ad has nothing to do with fundraising and everything to do with driving home the life saving and life changing potential of artificial pancreas technologies. And, every single person on this forum and those they know with diabetes has a stake in JDRF?s drive to accelerate progress on the Artificial Pancreas.

As some of you know, I?m a scientist at JDRF. I?ve worked at JDRF since 2004, helped launch and still oversee our Artificial Pancreas Project research efforts, and have overseen our hypoglycemia research funding for the past 7 years. On a personal note, I have a very personal connection to T1D. My brother was diagnosed at age 3 (in 1977) and I was diagnosed at 13 (1984). Like everyone reading and posting on these forums, my family has struggled (sometimes quite mightily) with this disease.

Given this personal connection to T1D, I understand why the 1 in 20 statistic has generated such an emotional response. It is alarming, even frightening. But it is not sensationalized as some have suggested. Unfortunately, this is based upon all of our current knowledge of the state of diabetes and we highlighted it to raise awareness among those at the FDA making a decision that affects my life, my brother?s life and your lives. Gary Feit from the JDRF has posted the basis for the statement in the ad. These are facts we ought not to run away from. In my family, severe hypoglycemia has been a 30 plus year battle that and a constant fear. I?ve given multiple glucagon injections and it is terrifying.

As I said, JDRF did not publish this ad to raise money. We ran this ad to tell the FDA that lives can be improved and even saved. We ran it because we want the FDA to understand that tools do exist to do this! JDRF-funded research has shown that predictive algorithms can minimize hypo by up to 80%. We can prevent many of these deaths. It is unacceptable to JDRF and it should be unacceptable to you that the United States is pretty much the only country in the world that hasn?t approved the Medtronic Veo pump that suspends insulin delivery when a person is low and non-responsive. This ad says to the FDA that they must get this guidance right.

I would welcome the chance to talk more about the amazing progress happening on ?closing the loop?. See www.jdrf.org for the press release we put out last week announcing the first real-world studies (funded by JDRF) of a closed-loop system. The first semi-automated systems are coming and could transform how we manage our diabetes. But, the big question is will they come to the United States at the same time as the rest of the world? Or will we be years behind? This is what the ad was about ? plain and simple.

[Brenda]

Just want to thank you for taking the time to respond.

[MommaKat]

Originally Posted by Aaron Kowalski

As I said, JDRF did not publish this ad to raise money. We ran this ad to tell the FDA that lives can be improved and even saved. We ran it because we want the FDA to understand that tools do exist to do this! JDRF-funded research has shown that predictive algorithms can minimize hypo by up to 80%. We can prevent many of these deaths. It is unacceptable to JDRF and it should be unacceptable to you that the United States is pretty much the only country in the world that hasn?t approved the Medtronic Veo pump that suspends insulin delivery when a person is low and non-responsive. This ad says to the FDA that they must get this guidance right.

I would welcome the chance to talk more about the amazing progress happening on ?closing the loop?. See www.jdrf.org for the press release we put out last week announcing the first real-world studies (funded by JDRF) of a closed-loop system. The first semi-automated systems are coming and could transform how we manage our diabetes. But, the big question is will they come to the United States at the same time as the rest of the world? Or will we be years behind? This is what the ad was about ? plain and simple.

Aaron, thanks for coming on the forum and responding directly. I appreciate that greatly, and am sure others will as well. You just reminded me of where I read information regarding FDA and the artificial pancreas, so thank you for that as well. I've been following the issue of the Medtronic Veo pump availability in the U.S. since my own daughter's had significant lows overnight that we can't seem to trouble shoot as of yet. (Adjustments to lantus don't mitigate them at all, and only lead to afternoon / evening highs.)

While you allude to some of the issues facing JDRF in terms of desired FDA approval, is it possible for you to be more specific here in the causes of existing or anticipated roadblocks in achieving FDA approval? Is there a specific timeline or FDA review of research findings that is prompting the increased pressure / ad campaign directed at the FDA regarding the artificial pancreas? Perhaps if we (collective) understood the reasons behind the ad as a sense of necessary urgency, the overt reaction would be different.

Thanks again for your post

[MHoskins2179]

Thanks for posting that explanation, Aaron.

[swellman]

Originally Posted by MommaKat

While you allude to some of the issues facing JDRF in terms of desired FDA approval, is it possible for you to be more specific here in the causes of existing or anticipated roadblocks in achieving FDA approval? Is there a specific timeline or FDA review of research findings that is prompting the increased pressure / ad campaign directed at the FDA regarding the artificial pancreas? Perhaps if we (collective) understood the reasons behind the ad as a sense of necessary urgency, the overt reaction would be different.

Yes, I would also appreciate information as to what impediments with the FDA required an ad, of what must have been many thousands of hard earned, walking dollars, that indirectly targeted our (my) government's agency that oversees these innovations accomplished that a face-to-face meeting or email correspondence could not have resolved.

Honestly, and I've been a staunch supporter of JRDF's historic direction of funds but, I have to admit that this one ad makes me feel like the last 5 years' of walks were thrown completely out the window.

Educate me.

[wilf]

I remain concerned that the one scientific "fact" in the ad appears to be based almost entirely on one author's (Dr. Cryer's) interpretation of a variety of studies done by others.

I do appreciate your posting here and making yourself available.

[Aaron Kowalski]

We have been working directly with FDA for a number of years now and have made strides, but the fact is that these tools exist and we don't have access. They could save live and transform how we manage diabetes. The Medtronic product (I have no financial conflicts here) is available in over 40 countries and has been for more than two and a half years. This is a product that stops a pump from delivering insulin when someone is low! On December 1 FDA will publish draft guidance for insulin-dosing artificial pancreas systems. Again, tests are going on that show that these systems work and could help eliminate a significant amount of high and low blood sugar - automatically! I imagine that we all would want to see these systems in the US at the same time as around the world.
The data says 1:20 or more. This is startling and is terrible. But even if it were one in a million -that is too many. I urge you to direct your frustration not at this statistic, but at the underlying problem. I can tell you that there is an amazing group of people at JDRF working to try to fix it. I'm part of the team, but like all of you I'm living it. And this group gives me a lot of hope. I'm sorry to say that I've had multiple discussions with people this year who have had this tragedy occur. If FDA moves faster and we save lives here - that is what this is all about. Let's change this statistic!

[kiwikid]

How can Public awareness of the Artificial Pancreas help change FDA policy?

[wilf]

Originally Posted by Aaron Kowalski

We have been working directly with FDA for a number of years now and have made strides, but the fact is that these tools exist and we don't have access. They could save live and transform how we manage diabetes. The Medtronic product (I have no financial conflicts here) is available in over 40 countries and has been for more than two and a half years. This is a product that stops a pump from delivering insulin when someone is low! On December 1 FDA will publish draft guidance for insulin-dosing artificial pancreas systems. Again, tests are going on that show that these systems work and could help eliminate a significant amount of high and low blood sugar - automatically! I imagine that we all would want to see these systems in the US at the same time as around the world.
The data says 1:20 or more. This is startling and is terrible. But even if it were one in a million -that is too many. I urge you to direct your frustration not at this statistic, but at the underlying problem. I can tell you that there is an amazing group of people at JDRF working to try to fix it. I'm part of the team, but like all of you I'm living it. And this group gives me a lot of hope. I'm sorry to say that I've had multiple discussions with people this year who have had this tragedy occur. If FDA moves faster and we save lives here - that is what this is all about. Let's change this statistic!

I agree that every person with Type 1 D who dies as a result of hypoglycemia is one too many. Anything that can be done to improve that statistic (whatever it is) is a positive step..

[swellman]

Originally Posted by kiwikid

How can Public awareness of the Artificial Pancreas help change FDA policy?

This is the part I'm missing as well ... how is an ad going to motivate the FDA? In fact, I would hope that it shouldn't - generally speaking. We have ties to the pharma industry and if all it took was an ad to get around impediments then all our dreams would come true. In my mind, personal agenda aside, that's not how it should work ... in my opinion.