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Post by sayhey24 on Apr 27, 2022 18:00:22 GMT -5
I don’t think for the vast majority it’s a lack of empathy or interest in their patients. Many are burned out or just have rogue motivations. The vast majority are still well-meaning and compassionate. Of those, you’ll have some that don’t stay current in research. Long story short, the biggest problem is a lack of data. The newer medications have so much information supporting their use, particularly in the later stages of the disease. Afrezza has none. If you’re going to have a paradigm shift, you cannot rely on old data for insulin but then say, “but this one is different”. Every claim in medicine needs to be supported, particularly when entering a crowded space full of several other well established options. For Afrezza to really shine, in my opinion, it would be best for MNKD to show trials that early intensive insulin treatment can safely and effectively halt disease progression and prolong complications. That way you have a solo agent being used that physicians feel comfortable with. Plus, they’ll likely be using lower doses of units to remove the “fear factor “. I don’t think this latest dosing study will have much of an effect by itself. If anything, it’ll just be that much more intimidating when a doctor suggests doubling the dose- if you can even convince a doctor to recommend that to their patients. This is going to take a long time to adopt as habits and fears slowly erode over time. It’s a completely different way of approaching the disease. You’re flipping the long-standing protocol on its head. That isn’t going to happen easily or quickly. It will start with the data. No amount of knowledge will replace experience Stevil - the vast amount of doctors need to bill. They need to get patients in and out of the door as fast as possible to increase billing. Medicine is being run by corporations now who are looking at making profit. For the most part Dr Welby is no longer even if down deep they still want to be Dr. Welby. We don't have a lack of data. We might have too much data. Every study needs another study and then another. What we have is a lack of packaging. Human insulin has not changed since man first showed up on this planet. Afrezza is human insulin. If a 50 year old study was done with pig insulin using human insulin could only improve the results. Think what results you can have if that human insulin can be introduced into the body which mimics how the pancreas naturally works? Thats afrezza. You want some studies showing early use of insulin in T2s here is just an overview of some studies. www.ncbi.nlm.nih.gov/pmc/articles/PMC3757533/The ORIGIN study found those people with prediabetes treated with insulin were 28% less likely to develop diabetes from the time of randomization until the first oral glucose tolerance test than those assigned to standard care (odds ratio [OR], 0.2; 95% CI, 0.58, 0.91; P=0.006). Based on this finding, the ORIGIN authors supported further research into the effect of insulin regimens on endocrine pancreatic function. All these guys want is more studies. Results with afrezza would only be better. The study being presented at ATTD 2022 this week while small is down right impressive. The thing is what this study shows is what had been said right here on Proboards for many years - afrezza was being under dosed and when dosing afrezza go big. The result that the higher dose of afrezza resulted in a mean difference of 52 mg/dL at 120 minutes is a game changer. This is HUGE. What would have happened during the Infinity-1 study if they dosed like this??? Wait - the doctor from NC did second dose and was publicly accused by the FDA at the Adcom of "Cheating". You can't make this stuff up. The problem my friend is a marketing and packaging problem. First, Al Mann screwed up with the label. He should never have used units. He should have just called the cartridges small, medium and large. Mike needs to fix this. Mike also needs to take all these studies which few doctors are going to read and boil it down to a simple, easy to follow SoC. Your AACE is now recommending all PWDs use a CGM for at least two weeks. Maybe Mike needs to have the ATTD come out with their own SoC which says after getting the 2 week AGP with the associated food history, start afrezza. These doctors don't want to read more studies which they probably have not read for starters. All these doctors want is a simple chart just like Perdue's simple smiley chart which got all those doctors prescribing Oxycontin. How many real studies were done with ocycontin which showed it was not addictive??? Maybe ZERO! The majority of these doctors want a simple easy to follow cheat sheet which is the SoC Mike needs to make up and get endorsed by someone and its not going to be the ADA. Get that "endorsed" SoC to the doctors and then these doctors can prescribe afrezza and get these patients out the door so they can bill more. BTW - last night I attended an educational session sponsored by UPenn Medicine. One of the fine moderators was pretty knowledgeable on T2 "prevention" through nutrition. I asked her her opinion on the new tech based nutrition diet companies like Levels and Nutrisense and their use of CGMs and that they are seeing loss of PPG control before gaining weight. I think that blew her mind. |
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Post by akemp3000 on Apr 27, 2022 21:26:05 GMT -5
Unfortunately, the pump has borne out in the data to be the most effective treatment option. Again, until Afrezza goes head to head and proves superiority in high quality studies, nothing is going to significantly change. And the Bentley has borne out in the data to be the better automobile than the Ford or Chevy. This is not going to play out that the pump will be the better mainstream solution. Al Mann will be proven right once again...IMHO |
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Post by sportsrancho on Apr 28, 2022 6:02:45 GMT -5
We/Vdex put people on pumps if that’s what they prefer. Sara in Owensboro has quite a few patients on them. Only thing is that’s not what they prefer when they get complete instructions on their options.
Would you?
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Reality
Apr 28, 2022 6:51:21 GMT -5
via mobile
Post by cjm18 on Apr 28, 2022 6:51:21 GMT -5
I don’t think for the vast majority it’s a lack of empathy or interest in their patients. Many are burned out or just have rogue motivations. The vast majority are still well-meaning and compassionate. Of those, you’ll have some that don’t stay current in research. Long story short, the biggest problem is a lack of data. The newer medications have so much information supporting their use, particularly in the later stages of the disease. Afrezza has none. If you’re going to have a paradigm shift, you cannot rely on old data for insulin but then say, “but this one is different”. Every claim in medicine needs to be supported, particularly when entering a crowded space full of several other well established options. For Afrezza to really shine, in my opinion, it would be best for MNKD to show trials that early intensive insulin treatment can safely and effectively halt disease progression and prolong complications. That way you have a solo agent being used that physicians feel comfortable with. Plus, they’ll likely be using lower doses of units to remove the “fear factor “. I don’t think this latest dosing study will have much of an effect by itself. If anything, it’ll just be that much more intimidating when a doctor suggests doubling the dose- if you can even convince a doctor to recommend that to their patients. This is going to take a long time to adopt as habits and fears slowly erode over time. It’s a completely different way of approaching the disease. You’re flipping the long-standing protocol on its head. That isn’t going to happen easily or quickly. It will start with the data. No amount of knowledge will replace experience Stevil - the vast amount of doctors need to bill. They need to get patients in and out of the door as fast as possible to increase billing. Medicine is being run by corporations now who are looking at making profit. For the most part Dr Welby is no longer even if down deep they still want to be Dr. Welby. We don't have a lack of data. We might have too much data. Every study needs another study and then another. What we have is a lack of packaging. Human insulin has not changed since man first showed up on this planet. Afrezza is human insulin. If a 50 year old study was done with pig insulin using human insulin could only improve the results. Think what results you can have if that human insulin can be introduced into the body which mimics how the pancreas naturally works? Thats afrezza. You want some studies showing early use of insulin in T2s here is just an overview of some studies. www.ncbi.nlm.nih.gov/pmc/articles/PMC3757533/The ORIGIN study found those people with prediabetes treated with insulin were 28% less likely to develop diabetes from the time of randomization until the first oral glucose tolerance test than those assigned to standard care (odds ratio [OR], 0.2; 95% CI, 0.58, 0.91; P=0.006). Based on this finding, the ORIGIN authors supported further research into the effect of insulin regimens on endocrine pancreatic function. All these guys want is more studies. Results with afrezza would only be better. The study being presented at ATTD 2022 this week while small is down right impressive. The thing is what this study shows is what had been said right here on Proboards for many years - afrezza was being under dosed and when dosing afrezza go big. The result that the higher dose of afrezza resulted in a mean difference of 52 mg/dL at 120 minutes is a game changer. This is HUGE. What would have happened during the Infinity-1 study if they dosed like this??? Wait - the doctor from NC did second dose and was publicly accused by the FDA at the Adcom of "Cheating". You can't make this stuff up. The problem my friend is a marketing and packaging problem. First, Al Mann screwed up with the label. He should never have used units. He should have just called the cartridges small, medium and large. Mike needs to fix this. Mike also needs to take all these studies which few doctors are going to read and boil it down to a simple, easy to follow SoC. Your AACE is now recommending all PWDs use a CGM for at least two weeks. Maybe Mike needs to have the ATTD come out with their own SoC which says after getting the 2 week AGP with the associated food history, start afrezza. These doctors don't want to read more studies which they probably have not read for starters. All these doctors want is a simple chart just like Perdue's simple smiley chart which got all those doctors prescribing Oxycontin. How many real studies were done with ocycontin which showed it was not addictive??? Maybe ZERO! The majority of these doctors want a simple easy to follow cheat sheet which is the SoC Mike needs to make up and get endorsed by someone and its not going to be the ADA. Get that "endorsed" SoC to the doctors and then these doctors can prescribe afrezza and get these patients out the door so they can bill more. BTW - last night I attended an educational session sponsored by UPenn Medicine. One of the fine moderators was pretty knowledgeable on T2 "prevention" through nutrition. I asked her her opinion on the new tech based nutrition diet companies like Levels and Nutrisense and their use of CGMs and that they are seeing loss of PPG control before gaining weight. I think that blew her mind. Origin study. Goal of the study was to prove insulin lowered cvd. It did not. I’d expect dm incidence to be higher in the control group. The control group was on 1 medication. The insulin group was on 2. Patients with IFG, IGT, or early type 2 DM, with elevated risk for a CV disease event, were randomized to insulin glargine given as a once daily injection in addition to their glycemic-control regimen or placebo. Dose could be increased weekly in the glargine insulin arm to achieve a self-measured finger stick blood glucose (FSBG) level ≤95 mg/dl. |
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Post by uvula on Apr 28, 2022 9:35:23 GMT -5
Unfortunately, the pump has borne out in the data to be the most effective treatment option. Again, until Afrezza goes head to head and proves superiority in high quality studies, nothing is going to significantly change. Unfortunate for us as investors. For T1s it is fortunate that there are 2 good options. (Pump and inhaled). For T2s, Afrezza makes more sense than a pump. |
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Post by sayhey24 on Apr 28, 2022 15:30:00 GMT -5
Unfortunately, the pump has borne out in the data to be the most effective treatment option. Again, until Afrezza goes head to head and proves superiority in high quality studies, nothing is going to significantly change. Unfortunate for us as investors. For T1s it is fortunate that there are 2 good options. (Pump and inhaled). For T2s, Afrezza makes more sense than a pump. According to Al, his vision was pretty simple - T1's use a patch pump and afrezza at meals and T2's use afrezza day one of being diagnosed. Simple right? The problem as stated from the guy who invented the pump was the insulin was too damn slow at meal time. This is why Al went looking for a faster insulin. His initial intent was to put it in the pump. When he and Sol came up with afrezza it was clear the solution was pump for basal and inhale for bolus. Its not an either pump or inhale, its both. The problem is the industry has spent a lot of time and money trying to come up with very complicated AP systems which are just not needed at this point. When the AP goes up against afrezza it always loses and always will because the insulin is too damn slow in the pumps. When Stevil says the pump study data wins is incorrect. It loses every time. |
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Post by sayhey24 on Apr 28, 2022 15:40:32 GMT -5
Stevil - the vast amount of doctors need to bill. They need to get patients in and out of the door as fast as possible to increase billing. Medicine is being run by corporations now who are looking at making profit. For the most part Dr Welby is no longer even if down deep they still want to be Dr. Welby. We don't have a lack of data. We might have too much data. Every study needs another study and then another. What we have is a lack of packaging. Human insulin has not changed since man first showed up on this planet. Afrezza is human insulin. If a 50 year old study was done with pig insulin using human insulin could only improve the results. Think what results you can have if that human insulin can be introduced into the body which mimics how the pancreas naturally works? Thats afrezza. You want some studies showing early use of insulin in T2s here is just an overview of some studies. www.ncbi.nlm.nih.gov/pmc/articles/PMC3757533/The ORIGIN study found those people with prediabetes treated with insulin were 28% less likely to develop diabetes from the time of randomization until the first oral glucose tolerance test than those assigned to standard care (odds ratio [OR], 0.2; 95% CI, 0.58, 0.91; P=0.006). Based on this finding, the ORIGIN authors supported further research into the effect of insulin regimens on endocrine pancreatic function. All these guys want is more studies. Results with afrezza would only be better. The study being presented at ATTD 2022 this week while small is down right impressive. The thing is what this study shows is what had been said right here on Proboards for many years - afrezza was being under dosed and when dosing afrezza go big. The result that the higher dose of afrezza resulted in a mean difference of 52 mg/dL at 120 minutes is a game changer. This is HUGE. What would have happened during the Infinity-1 study if they dosed like this??? Wait - the doctor from NC did second dose and was publicly accused by the FDA at the Adcom of "Cheating". You can't make this stuff up. The problem my friend is a marketing and packaging problem. First, Al Mann screwed up with the label. He should never have used units. He should have just called the cartridges small, medium and large. Mike needs to fix this. Mike also needs to take all these studies which few doctors are going to read and boil it down to a simple, easy to follow SoC. Your AACE is now recommending all PWDs use a CGM for at least two weeks. Maybe Mike needs to have the ATTD come out with their own SoC which says after getting the 2 week AGP with the associated food history, start afrezza. These doctors don't want to read more studies which they probably have not read for starters. All these doctors want is a simple chart just like Perdue's simple smiley chart which got all those doctors prescribing Oxycontin. How many real studies were done with ocycontin which showed it was not addictive??? Maybe ZERO! The majority of these doctors want a simple easy to follow cheat sheet which is the SoC Mike needs to make up and get endorsed by someone and its not going to be the ADA. Get that "endorsed" SoC to the doctors and then these doctors can prescribe afrezza and get these patients out the door so they can bill more. BTW - last night I attended an educational session sponsored by UPenn Medicine. One of the fine moderators was pretty knowledgeable on T2 "prevention" through nutrition. I asked her her opinion on the new tech based nutrition diet companies like Levels and Nutrisense and their use of CGMs and that they are seeing loss of PPG control before gaining weight. I think that blew her mind. Origin study. Goal of the study was to prove insulin lowered cvd. It did not. I’d expect dm incidence to be higher in the control group. The control group was on 1 medication. The insulin group was on 2. Patients with IFG, IGT, or early type 2 DM, with elevated risk for a CV disease event, were randomized to insulin glargine given as a once daily injection in addition to their glycemic-control regimen or placebo. Dose could be increased weekly in the glargine insulin arm to achieve a self-measured finger stick blood glucose (FSBG) level ≤95 mg/dl. OK - so the goal of the study was to prove insulin lowered cvd and it did not. Good. Why not? Any ideas??? I have a few. Even though the goal was not met something more important came from this study, Years later those people with prediabetes who were treated with insulin were 28% less likely to develop diabetes. Any idea why??? Sometimes goals are not met. The goal of Christopher Columbus was to sail west and find China. Well he failed at his goal. In this case the ORIGIN design would never allow it to meet its goal but the study provided some very important information on insulin use in early stage diabetes. Think of what would happen if we treated these early stage diabetics with afrezza and monitored them until they achieved beta cell regeneration? |
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Reality
Apr 28, 2022 15:45:48 GMT -5
via mobile
Post by uvula on Apr 28, 2022 15:45:48 GMT -5
Statistics can show whatever one wants.
I'm sure an expert t1d with afrezza can do better than an expert with an AP. But a typical td1 with an AP will do better than a typical t1d with afrezza, and it will take much less effort also.
T2d is where afrezza can have the most impact.
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Post by pbaumgarten on Apr 28, 2022 23:04:02 GMT -5
We/Vdex put people on pumps if that’s what they prefer. Sara in Owensboro has quite a few patients on them. Only thing is that’s not what they prefer when they get complete instructions on their options. Would you? Mind if I interrupt to inquire about VDEX? On their website, they have listed three locations in New Mexico and one in Owensboro, KY. There had been four clinics in New Mexico but now the Espagnola one is shown as "permanently closed." I'm not getting an impression of a thriving business -- is that a fair assessment? |
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Post by sayhey24 on Apr 29, 2022 6:21:42 GMT -5
Statistics can show whatever one wants. I'm sure an expert t1d with afrezza can do better than an expert with an AP. But a typical td1 with an AP will do better than a typical t1d with afrezza, and it will take much less effort also. T2d is where afrezza can have the most impact. We don't need statistics anymore, we can measure. We have CGMs. A T1 is typically never going to do better just using their pump to bolus at meal time than instead to use Afrezza for bolusing whether they use a pump or not. Get us a couple of PWDs and lets have Bill from VDex monitor them live. There was also good reason Nova Nordisk spent so much time developing Tresiba. Wearing a pump is not so great. There is a reason patch pumps like the omnipad were developed, tubes are not so great. With that said the T1 market is very small when compared to the T2 market. Afrezza should be the first medication prescribed for T2s. In fact we know even with aggressive diet and exercise 40% of prediabetics progress. What if we gave 100% on afrezza? Here is a pretty good youtube on the subject www.youtube.com/watch?v=94HT41Hennk&app=desktopThere is a really good youtube on the AP and how it works so much better using it with afrezza. I will look for it. |
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Post by sayhey24 on Apr 29, 2022 6:27:50 GMT -5
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Reality
Apr 29, 2022 6:28:19 GMT -5
via mobile
Post by cjm18 on Apr 29, 2022 6:28:19 GMT -5
www.acc.org/latest-in-cardiology/clinical-trials/2012/07/25/18/07/origin-basal-insulinOrigin study. Goal of the study was to prove insulin lowered cvd. It did not. I’d expect dm incidence to be higher in the control group. The control group was on 1 medication. The insulin group was on 2. Patients with IFG, IGT, or early type 2 DM, with elevated risk for a CV disease event, were randomized to insulin glargine given as a once daily injection in addition to their glycemic-control regimen or placebo. Dose could be increased weekly in the glargine insulin arm to achieve a self-measured finger stick blood glucose (FSBG) level ≤95 mg/dl. OK - so the goal of the study was to prove insulin lowered cvd and it did not. Good. Why not? Any ideas??? I have a few. Even though the goal was not met something more important came from this study, Years later those people with prediabetes who were treated with insulin were 28% less likely to develop diabetes. Any idea why??? Sometimes goals are not met. The goal of Christopher Columbus was to sail west and find China. Well he failed at his goal. In this case the ORIGIN design would never allow it to meet its goal but the study provided some very important information on insulin use in early stage diabetes. Think of what would happen if we treated these early stage diabetics with afrezza and monitored them until they achieved beta cell regeneration? The control group has the patients regular diabetes medication. The other group has the regular meds plus insulin. 2 meds is better than 1. Any 2 meds could be better than 1. Does insulin alone delay diagnosis of type2 more than the standard of care metformin. The insulin cartels could do a *trial to see if early insulin “cures” diabetes. Why don’t they do it. Shooting someone full of todays insulin causes insulin resistance. Insulin resistance causes high blood sugar. Note I said todays insulin. Afrezza might be different. Sglt2 Inhibitors are better suited for such the trial. |
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Reality
Apr 29, 2022 6:30:49 GMT -5
via mobile
Post by cjm18 on Apr 29, 2022 6:30:49 GMT -5
We/Vdex put people on pumps if that’s what they prefer. Sara in Owensboro has quite a few patients on them. Only thing is that’s not what they prefer when they get complete instructions on their options. Would you? Mind if I interrupt to inquire about VDEX? On their website, they have listed three locations in New Mexico and one in Owensboro, KY. There had been four clinics in New Mexico but now the Espagnola one is shown as "permanently closed." I'm not getting an impression of a thriving business -- is that a fair assessment? And didn’t they have CA locations? |
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Post by sayhey24 on Apr 29, 2022 7:21:18 GMT -5
OK - so the goal of the study was to prove insulin lowered cvd and it did not. Good. Why not? Any ideas??? I have a few. Even though the goal was not met something more important came from this study, Years later those people with prediabetes who were treated with insulin were 28% less likely to develop diabetes. Any idea why??? Sometimes goals are not met. The goal of Christopher Columbus was to sail west and find China. Well he failed at his goal. In this case the ORIGIN design would never allow it to meet its goal but the study provided some very important information on insulin use in early stage diabetes. Think of what would happen if we treated these early stage diabetics with afrezza and monitored them until they achieved beta cell regeneration? The control group has the patients regular diabetes medication. The other group has the regular meds plus insulin. 2 meds is better than 1. Any 2 meds could be better than 1. Does insulin alone delay diagnosis of type2 more than the standard of care metformin. The insulin cartels could do a *trial to see if early insulin “cures” diabetes. Why don’t they do it. Shooting someone full of todays insulin causes insulin resistance. Insulin resistance causes high blood sugar. Note I said todays insulin. Afrezza might be different. Sglt2 Inhibitors are better suited for such the trial. Why don't the insulin cartels could do a *trial to see if early insulin “cures” diabetes. Why don’t they do it. Are you kiidding??? Why? First - Injected insulins are dangerous. Second - there are a bunch of studies which have shown early insulin intervention stops and reverses progression BUT injected insulin is dangerous. UpJohn after German research during WWII took what they did and created an entire T2 market because insulin causes hypos and you need to inject. They created an entire industry because insulin is dangerous. Third - companies like Lilly want to make a lot of money in the T2 space by selling things like GLPs. www.clinicaltrialsarena.com/comment/eli-lilly-tirzepatide-outperform-diabetes-drugs/ If you want to make a lot of money the last thing you want to do is start them on afrezza and in 6 months half of them no longer need any medication. Good for afrezza but it kills a multi billion $$$ industry. In addition think about all the research dollars. Guys like Ralph DeFronzo has based is career promoting antiglycemics - first metformin, then GLP1s. This guy even developed the theory of insulin resistance to dissuade people from using insulin - their bodies were already making enough insulin so insulin was not the problem - sure Ralph. |
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Post by cjm18 on Apr 29, 2022 7:31:06 GMT -5
The control group has the patients regular diabetes medication. The other group has the regular meds plus insulin. 2 meds is better than 1. Any 2 meds could be better than 1. Does insulin alone delay diagnosis of type2 more than the standard of care metformin. The insulin cartels could do a *trial to see if early insulin “cures” diabetes. Why don’t they do it. Shooting someone full of todays insulin causes insulin resistance. Insulin resistance causes high blood sugar. Note I said todays insulin. Afrezza might be different. Sglt2 Inhibitors are better suited for such the trial. Why don't the insulin cartels could do a *trial to see if early insulin “cures” diabetes. Why don’t they do it. Are you kiidding??? Why? First - Injected insulins are dangerous. Second - there are a bunch of studies which have shown early insulin intervention stops and reverses progression BUT injected insulin is dangerous. UpJohn after German research during WWII took what they did and created an entire T2 market because insulin causes hypos and you need to inject. They created an entire industry because insulin is dangerous. Third - companies like Lilly want to make a lot of money in the T2 space by selling things like GLPs. www.clinicaltrialsarena.com/comment/eli-lilly-tirzepatide-outperform-diabetes-drugs/ If you want to make a lot of money the last thing you want to do is start them on afrezza and in 6 months half of them no longer need any medication. Good for afrezza but it kills a multi billion $$$ industry. In addition think about all the research dollars. Guys like Ralph DeFronzo has based is career promoting antiglycemics - first metformin, then GLP1s. This guy even developed the theory of insulin resistance to dissuade people from using insulin - their bodies were already making enough insulin so insulin was not the problem - sure Ralph. Mannkind investors might be okay if all Diabetics were on Afrezza for just 6 months. They would be right back on it later bc their diet had not changed. |
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