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JDRF Ad - Hypoglycemia

Discussion in 'Parents of Children with Type 1' started by Aaron Kowalski, Nov 2, 2011.

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  1. Aaron Kowalski

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    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.
     
  2. Brenda

    Brenda Junior Member

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

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    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
     
  4. MHoskins2179

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    Thanks for posting that explanation, Aaron.
     
  5. swellman

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    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.
     
  6. wilf

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    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. :cwds:
     
  7. Aaron Kowalski

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    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!
     
  8. kiwikid

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    How can Public awareness of the Artificial Pancreas help change FDA policy? :confused:
     
  9. wilf

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    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.. :cwds:
     
  10. swellman

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    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.
     
    Last edited: Nov 3, 2011
  11. MHoskins2179

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    I thought those newspaper ads were well done. I did question the 1:20 stat on first glance, but in seeing the studies cited I see it is completely legit. And I really think it is urgent and these ads are necessary.

    The necessity is that the FDA process is riddled with delays and, even with the public comment period, not many people actually take the time to make their voices heard on this. If the public is informed and behind this, then more might participate and make their voices heard. That, in turn, sends a stronger message to the FDA and lawmakers who would then be under more pressure to make sure these delays aren't happening.

    By US in the D-Community expressing our concerns and desires about what we want or don't want, by telling them what WE the taxpayers think should be done, then we are participating in the process the way it's designed.

    I'm by no means an expert, but the sense I get from listening to those intimately involved in this regularly process, is that this is long overdue and we need the Low Glucose Suspend like other countries outside the U.S. already allow. The FDA is the largest roadblock, and just be reviewing information about the questions and concerns officials seem to have, they aren't based on real practical concerns that PWD have. There's a disconnect - like let's not approve this because it takes away too much patient control, or that it could shut off insulin and cause higher A1Cs or long-term complications.

    This isn't what people who live with diabetes are concerned about when they go to bed at night - it's the not waking up part.

    THAT is the message the ads are trying to communicate to the general public that doesn't understand this insider baseball stuff of Living With Diabetes.

    We can have Promise meeting after Promise meeting, write letter after letter, and sign online petitions to the FDA. That's important. But so is educating the general public about what's going on, and spreading that awareness and bringing more attention to why this is needed NOW and not years from now, is only a good thing.

    My take.
     
  12. Darryl

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    Aaron,

    Thank you, and few questions if you are still here -

    How is the system working so far in other countries that shuts off insulin? It sounds like a great idea but have there been any unexpected problems?

    We use the minimed Guardian sensor and while it has worked amazingly well for us when the data is interpreted by our human judgement, there have been plenty of times when closed loop control would not have worked out well, such as when the sensor weakens near the end of life or if partially pulled out. At one point in the past you mentioned dual sensors. Is that still under consideration?
     
  13. MommaKat

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    This is exactly what I'm asking for. Are we in or coming close to a public comment period for either AP or Low Glucose Suspend? I understand that the FDA throws up roadblocks, and hearing what specific roadblocks / concerns are being raised re: these technologies would help us refine our response to the FDA. Is there lobbying against these technologies, and where is it coming from? If that information is available, it helps us understand the push, kwim? (There's a reason 40 other countries have what we don't, esp since Medtronic is here, so we have to ask who has a vested interest in keeping the Veo out of the U.S.)
     
  14. Becky Stevens mom

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    Aaron, I thank you for taking the time to come in and speak to us about the ad. As I said in an earlier post, I feel that the FDA is full of corruption. Ive read stories about them approving drugs that should have never been approved for use by the public then they wont approve others that could save lives. I also think there are not enough people employed by that organization or properly trained to do their jobs.

    I am concerned about the ads content. As a previous poster pointed out, how would that look to other people of non diabetic children wanting to have one of our kids stay over night or even come over and play? Its hard enough to make sure that my kid can go to his friends houses, go to school, ride the bus without people fearing he is going to pass away from his medical condition. If people see this ad Im afraid its going to get much harder for me. I do understand that people need to understand that this disease really isnt "no big deal" It is a big deal and we need to stop having our kids pass away from lows. We also need to stop losing our kids to undiagnosed or diagnosed too late type 1. But that is another subject of course.

    I think youve explained things very well and hope that the ad has its intended affect on the FDA to take this seriously.
     
  15. hawkeyegirl

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    I believe the public comment period is closed. I read the document that the FDA invited public comment on, and in my opinion, the idea that they were interested in the sort of comments that I would have been unable to add is laughable. It was very long, very, very technical, and very much geared toward the manufacturer of the products. For me, it might as well have been written in Sanskrit. They wanted comments on the actual procedure for clinical trials for the AP, not, "Please approve the VEO because my baby goes low at night a lot!"

    Of course the FDA realizes that we parents want the new technology ASAP. But, like a poster above said, I'd be worried if public pressure to approve a new device or drug held much sway with them.

    ETA: It's not that the FDA has a beef with the Veo. It's really all devices right now. They're making companies go through an awful lot of loops to get anything approved at this point. It's why Animas still doesn't have an integrated pump/CGM, and why the new Omnipod pods are nowhere to be seen, despite both having been promised years ago.

    (FYI, I think it's ludicrous that we don't have the VEO here yet. There should be some sort of fast-track process for products that have received the CE mark. I'm completely unimpressed with the VEO, but it is the first step to an AP.)
     
  16. Lisa P.

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    Thank you for your participation.

    I believe the last time JDRF participated in a public information campaign to influence policy it was successful in re-opening federal funding they wanted, so it seems ad campaigns that make emotional appeals have proven effective in that arena.

    Does JDRF have information on what research gains have been made following renewed funding in that instance?

    So, my understanding is that JDRF stands by the statistic and believes the campaign is necessary to speed approval of an artificial pancreas, which they believe will be effective for most Type 1 diabetes wanting to regulate their blood sugar automatically in the near future?

    And can you tell me, is the statistic based on all Type 1 diabetics, no matter age or other cognitive or medical condition (e.g. if hypoglycemia contributes to the death of someone in end stage renal disease, is it counted? If someone is suffering from dementia and there is a hospital error in dosing, is it counted?)? Is the statistic based on Type 2 diabetics who use insulin, also? Maybe you could spell it out for us, how the percentage is determined, is it 5% of all Type 1 diabetics who have ever lived but are now dead who died from lows? That would make more sense, considering past practices with insulin and testing. Is it 5% of all Type 1 diabetics who die within a given year, die from lows? Are we saying that 5% of all Type 1 diabetics below the age of 40 who die in a given year, die from lows (again, that might be understandable, since there are fewer causes of and incidents of death in that population so it would hike the percentage). Is it that 5% of all Type 1 diabetics are predicted to eventually die from lows? I think as parents we are trying to wrap our brains around the idea that if we know 40 diabetics, like in a support group or endo practice, 2 will die from a low.

    One death is too many, of course, and I certainly am not cavalier about the risk. You don't get up several times a night to check bg for fun, and I'm having a bit of an emotional kickback to the idea that you seem to imply that I am putting on blinders to the risk of lows -- I am not unaware that there is a serious risk of a dangerous or life-threatening low blood sugar level every time I inject my child -- every single time -- and I'm trying not to be insulted by the proposal that I need educating on that fact. But the statistic implies a much higher death rate than anyone here had ever heard before, and this is not an uneducated or uninformed group. Any clarity you can bring might help.

    I'll be curious to discuss this with my daughter's endo and get informal information from him about what percentage of his patients have died from lows.

    Thank you for your time.
     
  17. Deal

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    The main problem with the statistic used in the ad is that it doesn't pass the sniff test from those people who live closest to the disease. If indeed there are people under 40 dieing daily from lows you would think cases would naturally hit the media more often. The referenced material does not convince me either, if you take away the one author, the numbers quoted in other studies show a very different picture.

    I applaud the effort in working on the AP as an initiative. I look forward to the time when the AP has accurate inputs (dependable CGMS) because without that the project is a scholastic one in my view.
     
  18. OSUMom

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    Respectfully, an ad in major newspapers doesn't seem a method to communicate with the FDA. An ad such as this has a target audience of the public. This confuses me. I agree with some others who say a factual reference in the ad would be helpful. :cwds:
     
  19. selketine

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    I appreciate you taking the time to come on the board and respond.

    I would love it if the research behind the 1:20 was clearer to understand. Of course one in a billion trillion is one too many - no one will argue that point.

    I guess considering the percentage of people who pump (vs. shots) - the AP is only going to help them (unless shooters become pumpers). It seems to me that a more immediate fix would be more accurate, affordable, less invasive, and loud alarming cgms systems. I think if we are just looking at getting that 1:20 down - this would do it the quickest.

    Research on the AP, etc. has to continue - getting the low suspend, etc. to work right. But I think initially what would save the most lives quickly is getting better cgms systems to market. Since my son got a cgms I feel like I have a safety net - imperfect for sure - but it works. There is A LOT of room for improvement there.

    I live in the DC suburbs so I'm used to hearing and reading all sorts of "lobbying" ads like this - they are nothing unusual (particularly for the defense/security industry). Whether this ad was good or not so good - I can see both sides of that one and am on the fence myself.
     
  20. Aaron Kowalski

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    It's Aaron again and I'll try to answer some of the questions that are posted here. This is a fairly long post - I hope it is helpful.

    The statistic is based on lifetime risk. Hypoglycemia has evolved quite a bit since the DCCT trial and we see many fewer severe hypos. But, they certainly haven't been eliminated. In the JDRF CGM trial, we saw that a person with an A1c of 6.5 spends about 99 minutes a day - every day - below 70. All of us who live with or have a loved one with diabetes know how hard it is to maintain good blood sugar and lows are still a tremendous challenge. As one of the posters pointed out - this number will be low for people under 40 and then begin to rise. This should not change how people live their lives with diabetes (hey - I'm running the NYC Marathon on Sunday for the 3rd time with T1D, pump and CGM on board!) - but we should all be aware and use that awareness to minimize risk.

    What does the data look like? And what is the holdup at FDA? The data is compelling. The concern - which a few people have voiced here - is that the sensor would read low when the bg was really high. Could you get into a situation where you could get DKA? The data says no. The second concern is what if you get a bunch of false positives (not really low but the pump is shutting off) - could your A1c get worse while you?re not really preventing lows? The data that I've seen from the overseas use is that this doesn't happen either. So, this should be quite an easy one to move forward, yet it hasn't.

    Can public awareness help move FDA? Yes! We have been working to make sure that the voice people with T1D is represented in decision making at FDA. For example - would you be willing to trade the risk of a hypo seizure for an occasional false positive where you woke up a little higher than expected? What is the proper risk/benefit tradeoff for artificial pancreas systems? People with diabetes need to have a say and JDRF has led the way here. We have a petition that has been signed by over 100,000 people (see the following website to sign up and for much more information about all that is happening to move things forward faster http://advocacy.jdrf.org/index.cfm?page_id=109568) - everyone here should be weighing in. And, we've worked closely with the clinical societies - ADA, AADE, AACE, Endocrine Society - so healthcare providers have a voice as well. I urge everyone to get involved. We are making incredible progress on the artificial pancreas front, but this will hold true for all of the research we are doing - it all needs to eventually go to FDA - including the biological cures that we are making great progress on as well.
     
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