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Post by sportsrancho on Apr 1, 2018 7:53:19 GMT -5
Thankfully the doctors are not restricted by the label, and can prescribe off-label, that’s why we have kids on Afrezza:-)
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Post by agedhippie on Apr 1, 2018 10:29:48 GMT -5
Is that to say a doctor can only be presented whats on the label and can not discuss the attributes that are not . What the label says is "Dosing must be individualized". Based on the clamp study and the soon to be released STAT and Levin plus whatever Dr. Kendall is putting together plus clinical experience I think they have enough room on the label to individualize dosing as needed. I think we all know the answer to this. A doctor can say whatever they like, and prescribe whatever they like. When they step outside the label and the standard of care though they are exposing themselves to legal risk. That doesn't stop them if they feel strongly enough though. My endo regularly prescribed metformin to Type 1s because he had experience with the topic and was convinced that it helped with insulin resistance (which it does) despite being off-label for Type 1s. Eventually the rest of the medical community in the US caught up and metformin was approved for use in Type 1. |
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Post by peppy on Apr 1, 2018 15:15:01 GMT -5
What the label says is "Dosing must be individualized". Based on the clamp study and the soon to be released STAT and Levin plus whatever Dr. Kendall is putting together plus clinical experience I think they have enough room on the label to individualize dosing as needed. I think we all know the answer to this. A doctor can say whatever they like, and prescribe whatever they like. When they step outside the label and the standard of care though they are exposing themselves to legal risk. That doesn't stop them if they feel strongly enough though. My endo regularly prescribed metformin to Type 1s because he had experience with the topic and was convinced that it helped with insulin resistance (which it does) despite being off-label for Type 1s. Eventually the rest of the medical community in the US caught up and metformin was approved for use in Type 1. aged for type ones does metformin give them a bit of first phase insulin reaction? turns off gluconeogenesis? Giving a bit of the first phase to type ones? "Gluconeogenesis proceeds only in the liver and the kidneys, and since the liver is five times larger than the two kidneys combined, it synthesizes most of the glucose. The pathway does not occur in the brain, fat tissue, or skeletal muscle. Together with glycogen degradation (see slide 8.3.5), gluconeogenesis ensures stable blood glucose levels between meals. Gluconeogenesis also enables us to maintain the necessary glucose levels when on a diet that is rich in protein but low in carbohydrates."  |
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Post by agedhippie on Apr 1, 2018 16:19:10 GMT -5
I think we all know the answer to this. A doctor can say whatever they like, and prescribe whatever they like. When they step outside the label and the standard of care though they are exposing themselves to legal risk. That doesn't stop them if they feel strongly enough though. My endo regularly prescribed metformin to Type 1s because he had experience with the topic and was convinced that it helped with insulin resistance (which it does) despite being off-label for Type 1s. Eventually the rest of the medical community in the US caught up and metformin was approved for use in Type 1. aged for type ones does metformin give them a bit of first phase insulin reaction? turns off gluconeogenesis? Giving a bit of the first phase to type ones? "Gluconeogenesis proceeds only in the liver and the kidneys, and since the liver is five times larger than the two kidneys combined, it synthesizes most of the glucose. The pathway does not occur in the brain, fat tissue, or skeletal muscle. Together with glycogen degradation (see slide 8.3.5), gluconeogenesis ensures stable blood glucose levels between meals. Gluconeogenesis also enables us to maintain the necessary glucose levels when on a diet that is rich in protein but low in carbohydrates." Metformin reduces gluconeogenesis so you don't need to take as much basal insulin. Often that is seen as reducing your mealtime insulin because you are now covering effectively taking more basal insulin. It's partly why metformin is so effective in Type 2 - they tend to over-produce glucose through gluconeogenesis and metformin reduces that which drops their blood glucose. The other part of metformin is that it increases insulin sensitivity by improving binding to insulin receptors so you can do more with less insulin, and it improves glucose uptake by the muscles. It's why endos like it, it acts on a lot of points at once. Historically metformin was avoided for Type 1 because it was meant to trigger lactic acidosis, but a whole pile of research and studies have shown that this only happens if you have kidney damage, and even then it can be avoided by lowering the dose. |
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Post by peppy on Apr 1, 2018 17:16:37 GMT -5
I love you aged.
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Post by zuegirdor on Jul 12, 2018 11:40:09 GMT -5
Not saying this is anything but a personal turning point for Afrezza, but in the interests of full disclosure, as a follow up to the ongoing saga in our family's efforts to get Afrezza covered for my son (who is now in Adult medicine at Kaiser), and to fulfill a promise I made (on what thread I cannot remember) I announce with great cheer and thanks to all here, especially Leanne (Sports) and VDEX Diabetes that:
After much wrangling over availability we have been able to get Afrezza covered with minimal copay at Kaiser based upon our direct appeal to his new endo. The decision, other than mercy, may have been (so far as I can tell) our reporting that for the year and a half we paid out of pocket it kept his A1C at 6.0 with reduced hypos and enormous psychological relief. We added that we did not believe he could keep his A1c safely below 7.0 without it.
This is an enormous psychic, emotional and economic releif for me and my family. I am so appreciative for what his endo has done for us. Afrezza is still not on the formulary, though this endo did have one other patient on Afrezza.
I have no recommendation for others. I am completely humbled by our journey, all the help and hindrances we have weathered to get here. We are grateful, but the mountain stretches far above our heads still. I'm holding out for the cure.
I thought by posting on various online media I could make a difference in how many people tried Afrezza and thus help them lessen the burden of their diabetes in their lives, even if just a smidge. I thought I could help investors understand what it means to be a family living with this awful condition (type one). To be honest, I am not so sure that a person can have a great effect on behavior of bad pharma actors, shorts or patients online (Sam, Eric, Brian, afrezzaguy, Laureen, Basualdo et al notwithstanding).
I don't know how much I will post here going forward. (I tossed my twitter app too - rabbit hole that raises my blood pressure). But, good wishes to all for now.
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Post by sportsrancho on Jul 12, 2018 14:12:32 GMT -5
Not saying this is anything but a personal turning point for Afrezza, but in the interests of full disclosure, as a follow up to the ongoing saga in our family's efforts to get Afrezza covered for my son (who is now in Adult medicine at Kaiser), and to fulfill a promise I made (on what thread I cannot remember) I announce with great cheer and thanks to all here, especially Leanne (Sports) and VDEX Diabetes that: After much wrangling over availability we have been able to get Afrezza covered with minimal copay at Kaiser based upon our direct appeal to his new endo. The decision, other than mercy, may have been (so far as I can tell) our reporting that for the year and a half we paid out of pocket it kept his A1C at 6.0 with reduced hypos and enormous psychological relief. We added that we did not believe he could keep his A1c safely below 7.0 without it. This is an enormous psychic, emotional and economic releif for me and my family. I am so appreciative for what his endo has done for us. Afrezza is still not on the formulary, though this endo did have one other patient on Afrezza. I have no recommendation for others. I am completely humbled by our journey, all the help and hindrances we have weathered to get here. We are grateful, but the mountain stretches far above our heads still. I'm holding out for the cure. I thought by posting on various online media I could make a difference in how many people tried Afrezza and thus help them lessen the burden of their diabetes in their lives, even if just a smidge. I thought I could help investors understand what it means to be a family living with this awful condition (type one). To be honest, I am not so sure that a person can have a great effect on behavior of bad pharma actors, shorts or patients online (Sam, Eric, Brian, afrezzaguy, Laureen, Basualdo et al notwithstanding). I don't know how much I will post here going forward. (I tossed my twitter app too - rabbit hole that raises my blood pressure). But, good wishes to all for now. You have made a huge difference! I know how daunting it can be...the people on Twitter, the shorts are relentless, but the people that care and need help see your journey. And your love for your son and family. And you are part of our family here:-) Much respect for your tenacity in getting through all this! |
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Post by cretin11 on Jul 12, 2018 14:55:13 GMT -5
zuegirdor, thank you for sharing this great update, please keeping spreading the word out there! You're helping people, even if only a small number benefit from it.
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Post by bones1026 on Jul 12, 2018 15:31:10 GMT -5
Not saying this is anything but a personal turning point for Afrezza, but in the interests of full disclosure, as a follow up to the ongoing saga in our family's efforts to get Afrezza covered for my son (who is now in Adult medicine at Kaiser), and to fulfill a promise I made (on what thread I cannot remember) I announce with great cheer and thanks to all here, especially Leanne (Sports) and VDEX Diabetes that: After much wrangling over availability we have been able to get Afrezza covered with minimal copay at Kaiser based upon our direct appeal to his new endo. The decision, other than mercy, may have been (so far as I can tell) our reporting that for the year and a half we paid out of pocket it kept his A1C at 6.0 with reduced hypos and enormous psychological relief. We added that we did not believe he could keep his A1c safely below 7.0 without it. This is an enormous psychic, emotional and economic releif for me and my family. I am so appreciative for what his endo has done for us. Afrezza is still not on the formulary, though this endo did have one other patient on Afrezza. I have no recommendation for others. I am completely humbled by our journey, all the help and hindrances we have weathered to get here. We are grateful, but the mountain stretches far above our heads still. I'm holding out for the cure. I thought by posting on various online media I could make a difference in how many people tried Afrezza and thus help them lessen the burden of their diabetes in their lives, even if just a smidge. I thought I could help investors understand what it means to be a family living with this awful condition (type one). To be honest, I am not so sure that a person can have a great effect on behavior of bad pharma actors, shorts or patients online (Sam, Eric, Brian, afrezzaguy, Laureen, Basualdo et al notwithstanding). I don't know how much I will post here going forward. (I tossed my twitter app too - rabbit hole that raises my blood pressure). But, good wishes to all for now. As much as we all like to hear about potential enhancements in insurance as it relates to our investment...even better to hear the huge positive impact on your sons health, while simultaneously alleviating the stress/fears I’m sure this whole insurance debacle has had on you and your family...that always takes precedence over $ |
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Post by sportsrancho on Jul 12, 2018 16:31:51 GMT -5
From Mike C:
“Nate and all our shareholders thank you for your support and venting your frustrations. It’s been a wild ride for sure. In the end, we are on the same team and we have overcome more obstacles than any company I know. The culture and winning attitude we have will prevail.”
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Post by awesomo on Jul 12, 2018 16:35:14 GMT -5
From Mike C: “Nate and all our shareholders thank you for your support and venting your frustrations. It’s been a wild ride for sure. In the end, we are on the same team and we have overcome more obstacles than any company I know. The culture and winning attitude we have will prevail.” Where did he post/say this? |
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Post by sportsrancho on Jul 12, 2018 16:53:55 GMT -5
From Mike C: “Nate and all our shareholders thank you for your support and venting your frustrations. It’s been a wild ride for sure. In the end, we are on the same team and we have overcome more obstacles than any company I know. The culture and winning attitude we have will prevail.” From Mike..”Just leaving the annual diabetes @atdccon conference in Denver and it was great watching Dr Bailey, Dr Kayne, Dr Peters present this morning at our MannKind Symposium! Day by day we educate more people!” |
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Post by golfeveryday on Jul 12, 2018 18:14:15 GMT -5
Not saying this is anything but a personal turning point for Afrezza, but in the interests of full disclosure, as a follow up to the ongoing saga in our family's efforts to get Afrezza covered for my son (who is now in Adult medicine at Kaiser), and to fulfill a promise I made (on what thread I cannot remember) I announce with great cheer and thanks to all here, especially Leanne (Sports) and VDEX Diabetes that: After much wrangling over availability we have been able to get Afrezza covered with minimal copay at Kaiser based upon our direct appeal to his new endo. The decision, other than mercy, may have been (so far as I can tell) our reporting that for the year and a half we paid out of pocket it kept his A1C at 6.0 with reduced hypos and enormous psychological relief. We added that we did not believe he could keep his A1c safely below 7.0 without it. This is an enormous psychic, emotional and economic releif for me and my family. I am so appreciative for what his endo has done for us. Afrezza is still not on the formulary, though this endo did have one other patient on Afrezza. I have no recommendation for others. I am completely humbled by our journey, all the help and hindrances we have weathered to get here. We are grateful, but the mountain stretches far above our heads still. I'm holding out for the cure. I thought by posting on various online media I could make a difference in how many people tried Afrezza and thus help them lessen the burden of their diabetes in their lives, even if just a smidge. I thought I could help investors understand what it means to be a family living with this awful condition (type one). To be honest, I am not so sure that a person can have a great effect on behavior of bad pharma actors, shorts or patients online (Sam, Eric, Brian, afrezzaguy, Laureen, Basualdo et al notwithstanding). I don't know how much I will post here going forward. (I tossed my twitter app too - rabbit hole that raises my blood pressure). But, good wishes to all for now. As much as we all like to hear about potential enhancements in insurance as it relates to our investment...even better to hear the huge positive impact on your sons health, while simultaneously alleviating the stress/fears I’m sure this whole insurance debacle has had on you and your family...that always takes precedence over $ we just got Afrezza Prior Auth approved in less than 48 hours for 4Units for a year. 👍🏻 |
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Post by sayhey24 on Jul 12, 2018 19:26:30 GMT -5
Zuegirdor - Congratulations to you and your family. It is unfortunate you needed to go through what you did.
Hopefully over the next six months Dr. Kendall can bulldoze the path for future T1 afrezza users by getting the needed changes to the standard of care.
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Post by sportsrancho on Jul 12, 2018 22:01:41 GMT -5
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