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Post by goyocafe on Jun 9, 2019 0:31:16 GMT -5
If you and I recognize the limitations of subq injections of a ultra-rapid acting insulin, why does the ADA seem to insist on funding further research and ignore the opportunity right in front of it to help PWDs today? Any new drug using PEG or other means of changing the route or method of administration is years away. Afrezza is sitting on a cold shelf in your pharmacy today. Someone has to call the ADA out on this. I can't believe those in charge of Afrezza and those at the helm of all the various diabetes organizations are so mum on this issue. It's all about the artificial pancreas. URLi and FIASP have less than ideal profiles for a rapid in/rapid out insulin, and Afrezza is a non-starter because you cannot automatically dispense it, so the ADA is funding research into a rapid in/rapid out pumpable insulin. A non-starter? So when the Model T was developed, Ford said F it, it’s not autonomous driving capable and doesn’t have air bags. No way we should build it. I completely disagree with your premise. Why deny PWDs with better outcomes using a hybrid solution with CGM , basal, and Afrezza while they seek out a better solution. Any other mindset tells me there’s more to this than simple naivety or ignorance. |
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Post by peppy on Jun 9, 2019 10:52:38 GMT -5
Quote: The ADA is in search of an ultra-fast acting insulin (and funding that research) because they see the potential it holds for helping PWDs. Reply: that is not going to happen with subq. Subcutaneous tissue has few blood vessels and so drugs injected here are for slow, sustained rates of absorption.[3] It is slower than intramuscular injections but still faster than intradermal injections.[3] They tried adding niacin. www.screencast.com/t/PEg65lsi9W2FIf you and I recognize the limitations of subq injections of a ultra-rapid acting insulin, why does the ADA seem to insist on funding further research and ignore the opportunity right in front of it to help PWDs today? Any new drug using PEG or other means of changing the route or method of administration is years away. Afrezza is sitting on a cold shelf in your pharmacy today. Someone has to call the ADA out on this. I can't believe those in charge of Afrezza and those at the helm of all the various diabetes organizations are so mum on this issue. Lip service and patent expirations. The ADA works for the system. The money making industrial system. I have started thinking about the real business tactics that come into play. Two years ago, were we all aware of catch and kill? |
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Post by agedhippie on Jun 9, 2019 11:49:33 GMT -5
Sort of. I think the problem the ADA is trying to get around is that Lilly and Novo Nordisk have just spent a lot of money bring their new insulins to the market so they would like those used in the artificial pancreas pumps and are not about to fund research on a new rapid in/rapid out insulin. By funding this research the ADA is raising the threat of a competitor and so forcing them to keep going. |
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Post by agedhippie on Jun 9, 2019 12:01:13 GMT -5
It's all about the artificial pancreas. URLi and FIASP have less than ideal profiles for a rapid in/rapid out insulin, and Afrezza is a non-starter because you cannot automatically dispense it, so the ADA is funding research into a rapid in/rapid out pumpable insulin. A non-starter? So when the Model T was developed, Ford said F it, it’s not autonomous driving capable and doesn’t have air bags. No way we should build it. I completely disagree with your premise. Why deny PWDs with better outcomes using a hybrid solution with CGM , basal, and Afrezza while they seek out a better solution. Any other mindset tells me there’s more to this than simple naivety or ignorance. Nobody is denying people the ability to take Afrezza, that choice is untouched. I use xDrip which can be used as part of a DIY artificial pancreas however I use it without a pump. xDrip tells me how many units I need to take and I inject that, you could equally inhale it if you configured xDrip to understand Afrezza (there are activity curves that would need to be modified). All of that said, the 670G hybrid AP outperforms Afrezza for TIR and it's next pump, the 780G, which is meant to be released either this or early next year has a better than 80% TIR. |
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Post by goyocafe on Jun 9, 2019 12:28:02 GMT -5
A non-starter? So when the Model T was developed, Ford said F it, it’s not autonomous driving capable and doesn’t have air bags. No way we should build it. I completely disagree with your premise. Why deny PWDs with better outcomes using a hybrid solution with CGM , basal, and Afrezza while they seek out a better solution. Any other mindset tells me there’s more to this than simple naivety or ignorance. Nobody is denying people the ability to take Afrezza, that choice is untouched. I use xDrip which can be used as part of a DIY artificial pancreas however I use it without a pump. xDrip tells me how many units I need to take and I inject that, you could equally inhale it if you configured xDrip to understand Afrezza (there are activity curves that would need to be modified). All of that said, the 670G hybrid AP outperforms Afrezza for TIR and it's next pump, the 780G, which is meant to be released either this or early next year has a better than 80% TIR. So then your expectation should be that the ADA remove all injectable RAA from their SOC since the only real solutions are the ones you noted above. My point is that as long as they are advocating the use of injectable RAA at some point in the progression of the malady, they should at least be doing the same for inhaled insulin. It is, after all, even using the lowest denominator, non-inferior to its competitors. My beef with the ADA is that they will not list inhaled insulin along side injectable RAA as part of the SOC. For an agency with so much clout be in a position to cherry pick solutions based on who contributes the most money just soils their image, to say the least. I just wish that Mannkind would step up and say what it is that's really going on. If the ADA has ruled out ever mentioning inhaled insulin other than an "alternate treatment option", then what does it hurt to bring this fight to the public arena? |
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Post by longliner on Jun 9, 2019 12:35:08 GMT -5
Nobody is denying people the ability to take Afrezza, that choice is untouched. I use xDrip which can be used as part of a DIY artificial pancreas however I use it without a pump. xDrip tells me how many units I need to take and I inject that, you could equally inhale it if you configured xDrip to understand Afrezza (there are activity curves that would need to be modified). All of that said, the 670G hybrid AP outperforms Afrezza for TIR and it's next pump, the 780G, which is meant to be released either this or early next year has a better than 80% TIR. So then your expectation should be that the ADA remove all injectable RAA from their SOC since the only real solutions are the ones you noted above. My point is that as long as they are advocating the use of injectable RAA at some point in the progression of the malady, they should at least be doing the same for inhaled insulin. It is, after all, even using the lowest denominator, non-inferior to its competitors. My beef with the ADA is that they will not list inhaled insulin along side injectable RAA as part of the SOC. For an agency with so much clout be in a position to cherry pick solutions based on who contributes the most money just soils their image, to say the least. I just wish that Mannkind would step up and say what it is that's really going on. If the ADA has ruled out ever mentioning inhaled insulin other than an "alternate treatment option", then what does it hurt to bring this fight to the public arena? Goyo, while I fully embrace your argument, I have to chuckle at the "soils their image" phrase. Last time I looked the entire FDA annual budget is covered by large tobacco. (And quite possibly the headstone industry)  Sorry, my bad, you are discussing ADA, my mind made the leap to FDA. |
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Post by agedhippie on Jun 9, 2019 13:12:57 GMT -5
So then your expectation should be that the ADA remove all injectable RAA from their SOC since the only real solutions are the ones you noted above. My point is that as long as they are advocating the use of injectable RAA at some point in the progression of the malady, they should at least be doing the same for inhaled insulin. It is, after all, even using the lowest denominator, non-inferior to its competitors. My beef with the ADA is that they will not list inhaled insulin along side injectable RAA as part of the SOC. For an agency with so much clout be in a position to cherry pick solutions based on who contributes the most money just soils their image, to say the least. I just wish that Mannkind would step up and say what it is that's really going on. If the ADA has ruled out ever mentioning inhaled insulin other than an "alternate treatment option", then what does it hurt to bring this fight to the public arena? Yeah. I would not argue with your position there at all. Since non-inferiority has been established they should have it listed alongside RAA. |
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Post by peppy on Jun 9, 2019 17:41:38 GMT -5
If you and I recognize the limitations of subq injections of a ultra-rapid acting insulin, why does the ADA seem to insist on funding further research and ignore the opportunity right in front of it to help PWDs today? Any new drug using PEG or other means of changing the route or method of administration is years away. Afrezza is sitting on a cold shelf in your pharmacy today. Someone has to call the ADA out on this. I can't believe those in charge of Afrezza and those at the helm of all the various diabetes organizations are so mum on this issue. URLi and FIASP have less than ideal profiles for a rapid in/rapid out insulin, and Afrezza is a non-starter because you cannot automatically dispense it, so the ADA is funding research into a rapid in/rapid out pumpable insulin. quote: It's all about the artificial pancreas. agedhippie, in the title, artificial as in made up solan. Fiasp my ass. The whole system counts on people being stupid and word salad. And you know this. you are sounding delusional.  Didn't Nixon launch the war on cancer? National Cancer Act of 1971 President Richard Nixon signing the National Cancer Act of 1971. Credit: National Cancer Institute The National Cancer Institute was established in its current form by the National Cancer Act of 1971, signed into law by President Richard Nixon. This legislation was an amendment to the Public Health Service Act of 1944 and represented the U.S. commitment to what President Nixon described as the “war on cancer,” which had become the nation’s second leading cause of tell me exactly how this artificial pancreas is going to work please? |
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Post by agedhippie on Jun 9, 2019 18:50:46 GMT -5
... tell me exactly how this artificial pancreas is going to work please? This is a bit of a cheat, but I am going to point you at the OpenAPS site ( openaps.org/) because they explain it far better than I can. In all seriousness, if you want to see what the community is doing, and how their APS works then this site is excellent. The DIY APS projects are all ahead of the approved solution because they are not FDA approved. The FDA has recently issued a PR bitching about this, but since it's not commercial (it's DIY!) there is not a lot they can do. |
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Post by peppy on Jun 9, 2019 19:01:08 GMT -5
... tell me exactly how this artificial pancreas is going to work please? This is a bit of a cheat, but I am going to point you at the OpenAPS site ( openaps.org/) because they explain it far better than I can. In all seriousness, if you want to see what the community is doing, and how their APS works then this site is excellent. The DIY APS projects are all ahead of the approved solution because they are not FDA approved. The FDA has recently issued a PR bitching about this, but since it's not commercial (it's DIY!) there is not a lot they can do. "OpenAPS is an open and transparent effort to make safe and effective basic Artificial Pancreas System (APS) technology widely available to more quickly improve and save as many lives as possible and reduce the burden of Type 1 diabetes. The community has created a safety-focused reference design and a reference implementation of an overnight closed loop APS system that uses CGM sensors’ estimate of blood glucose (BG) to automatically adjust basal insulin levels, in order to keep BG levels inside a safe range overnight and between meals." I see. Thanks. |
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Post by sellhighdrinklow on Jun 9, 2019 21:01:32 GMT -5
If you and I recognize the limitations of subq injections of a ultra-rapid acting insulin, why does the ADA seem to insist on funding further research and ignore the opportunity right in front of it to help PWDs today? Any new drug using PEG or other means of changing the route or method of administration is years away. Afrezza is sitting on a cold shelf in your pharmacy today. Someone has to call the ADA out on this. I can't believe those in charge of Afrezza and those at the helm of all the various diabetes organizations are so mum on this issue. It's all about the artificial pancreas. URLi and FIASP have less than ideal profiles for a rapid in/rapid out insulin, and Afrezza is a non-starter because you cannot automatically dispense it, so the ADA is funding research into a rapid in/rapid out pumpable insulin. Mr./Ms. Hippie. Is that all you have to voice your continuous negativity here on mnkd and this topic? Wow. Please try again. |
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Post by prcgorman2 on Jun 9, 2019 21:04:08 GMT -5
sdrc.stanford.edu/eric-appel"The Appel lab at Stanford integrates concepts and approaches from supramolecular chemistry and natural/synthetic materials to tackle healthcare challenges of critical importance to society, including diabetes mellitus. They have developed a platform of materials with unique, tunable, and stimuli-responsive properties that they are exploiting as the basis for novel treatment strategies for a range of disease targets. Relevant to diabetes, Appel’s group has developed “smart” excipient technology affording unprecedented stabilization of monomeric insulin, a strategy that forms the basis of novel ultra-fast-acting insulin formulations for treatment of diabetes. They have several on-going collaborations with multiple members of the Stanford DRC that focus on the translation of their new material technologies." If only there were a way to inject Afrezza instead of having to inhale it! |
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Post by goyocafe on Jun 9, 2019 21:09:49 GMT -5
sdrc.stanford.edu/eric-appel"The Appel lab at Stanford integrates concepts and approaches from supramolecular chemistry and natural/synthetic materials to tackle healthcare challenges of critical importance to society, including diabetes mellitus. They have developed a platform of materials with unique, tunable, and stimuli-responsive properties that they are exploiting as the basis for novel treatment strategies for a range of disease targets. Relevant to diabetes, Appel’s group has developed “smart” excipient technology affording unprecedented stabilization of monomeric insulin, a strategy that forms the basis of novel ultra-fast-acting insulin formulations for treatment of diabetes. They have several on-going collaborations with multiple members of the Stanford DRC that focus on the translation of their new material technologies." If only there were a way to inject Afrezza instead of having to inhale it! Who’d of thought it. 🤔 |
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Post by sellhighdrinklow on Jun 9, 2019 21:09:51 GMT -5
A non-starter? So when the Model T was developed, Ford said F it, it’s not autonomous driving capable and doesn’t have air bags. No way we should build it. I completely disagree with your premise. Why deny PWDs with better outcomes using a hybrid solution with CGM , basal, and Afrezza while they seek out a better solution. Any other mindset tells me there’s more to this than simple naivety or ignorance. Nobody is denying people the ability to take Afrezza, that choice is untouched. I use xDrip which can be used as part of a DIY artificial pancreas however I use it without a pump. xDrip tells me how many units I need to take and I inject that, you could equally inhale it if you configured xDrip to understand Afrezza (there are activity curves that would need to be modified). All of that said, the 670G hybrid AP outperforms Afrezza for TIR and it's next pump, the 780G, which is meant to be released either this or early next year has a better than 80% TIR. Interesting. I've never heard of xdrip. What I find interesting is you need some sort of app to tell you what to inject AND you believe it. I trust myself and my knowledge of living w Type 1 for 80% of my life. Does xdrip factor in exercise during any given day, which carries forward , speeding up a Type 1's metabolism such that an xdrip app could/would/will drop you into hypo mode quickly? How long have you been Type 1, Hippie? |
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Post by prcgorman2 on Jun 9, 2019 21:15:57 GMT -5
If only there were a way to inject Afrezza instead of having to inhale it! Who’d of thought it. 🤔 Afrezza wettable powder? The lungs are a pretty moist place so Afrezza isn’t completely useless wet. Almost not joking here. It would have been interesting if the ADA had held a competition with a prize instead of handing someone cash. Was there an RFP? Was Mannkind permitted to bid? |
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Sorry, my bad, you are discussing ADA, my mind made the leap to FDA. 
