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Post by stevil on Mar 25, 2022 9:12:45 GMT -5
Stevil - you may be on to something here Maybe VDex needs to be working Indian Health Services to get changes made to their guide since they are doing so much work in New Mexico with native Americans. The AACE is an interesting organization - American Association of Clinical Endocrinology I went through their "Use of Advanced Technology in the Management of Persons With Diabetes Mellitus". It lays out a lot of the things we have been discussing such as extensive use of CGMs day 1. Things like Q2.4 When should diagnostic/professional continuous glucose monitoring be considered? - Newly diagnosed with diabetes mellitus - Persons with T2D treated with non-insulin therapies who would benefit from episodic use of CGM as an educational tool The Co-Chair who put this together is George Grunberger - former president of the AACE While the guide talks extensively about CGMs and their benefits there is not one mention of inhaled insulin or afrezza. The obvious question is did George never hear of afrezza? The answer is No. In fact George had worked with Mike Hoskins to get insurance authorization to use afrezza. Here is an oldy but goody www.ajmc.com/view/patients-report-barriers-to-getting-afrezza-but-a1c-results-are-worth-itIt also mentioned Saveth in addition to Hoskins. Five years later I wonder what happened to both? It will take these types of collaborations to fund the research necessary to sway expert opinion. This would be a huge undertaking, but it could certainly be beneficial for all parties involved. Historically, Native Americans have been one of the most difficult populations to treat, so I'm not sure I would want Afrezza to cut its teeth there... although if you have the confidence it'll work and want to make a splash, that's where you could do it. Plus, there would likely be adequate funding if you could convince the IHS it would be worthwhile. Just make sure you have the right providers that are up for the task. Very high provider burnout... |
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Post by sayhey24 on Mar 25, 2022 10:47:38 GMT -5
Stevil - you may be on to something here Maybe VDex needs to be working Indian Health Services to get changes made to their guide since they are doing so much work in New Mexico with native Americans. The AACE is an interesting organization - American Association of Clinical Endocrinology I went through their "Use of Advanced Technology in the Management of Persons With Diabetes Mellitus". It lays out a lot of the things we have been discussing such as extensive use of CGMs day 1. Things like Q2.4 When should diagnostic/professional continuous glucose monitoring be considered? - Newly diagnosed with diabetes mellitus - Persons with T2D treated with non-insulin therapies who would benefit from episodic use of CGM as an educational tool The Co-Chair who put this together is George Grunberger - former president of the AACE While the guide talks extensively about CGMs and their benefits there is not one mention of inhaled insulin or afrezza. The obvious question is did George never hear of afrezza? The answer is No. In fact George had worked with Mike Hoskins to get insurance authorization to use afrezza. Here is an oldy but goody www.ajmc.com/view/patients-report-barriers-to-getting-afrezza-but-a1c-results-are-worth-itIt also mentioned Saveth in addition to Hoskins. Five years later I wonder what happened to both? It will take these types of collaborations to fund the research necessary to sway expert opinion. This would be a huge undertaking, but it could certainly be beneficial for all parties involved. Historically, Native Americans have been one of the most difficult populations to treat, so I'm not sure I would want Afrezza to cut its teeth there... although if you have the confidence it'll work and want to make a splash, that's where you could do it. Plus, there would likely be adequate funding if you could convince the IHS it would be worthwhile. Just make sure you have the right providers that are up for the task. Very high provider burnout... The one thing about needing more research is that the new research then says we need more research. Its always the recursive plunge. Do we really need more research? Dave Kendall had a stack of studies, his veins of gold and he believed changing the SoC would be the easiest job he every had. When he brought this research to the ADA he got stonewalled and he failed. I don't think more research is the answer. We have more than enough to get started and the large scale India study in progress. A big part of the VDex business is Native Amercians. I don't know if VDex would have better luck with the IHS than Dave kendall had with the ADA. If we are to believe what VDex is saying they have had eye-popping clinical results. Since a main focus of the New Mexico offices are focused on the Native Americans, approaching and working with the IHS seems like a natural to me. Maybe they have already done this. I have no idea. If they have not I don't think they need more research. I think they just need to get Dave's studies and combine it with there clinical results. If the IHS wants to fund a clinical study with VDex The end result of what VDex would need and what Mike needs for his Seeing is Believing is a simple treatment card. Taking some of the thoughts which the AACE has already published with use of CGM and AGPs and adding afrezza. The AACE is already using words like early insulin use. They just fail to make any mention of afrezza even though George Grunberger the guides developer promoted afrezza use outside of the AACE. Maybe the card can not be as simple as what Perdue did for OC but it should be simple and not the mess which the ADA has. It clearly needs to point to the use of CGMs, AGP and afrezza and sum up what Mike's campaign is all about Here is what Perdue did www.google.com/imgres?imgurl=https%3A%2F%2Fheroin.palmbeachpost.com%2Fwp-content%2Fuploads%2F2018%2F05%2FHospital-pain-threshold-board-1.jpg&imgrefurl=https%3A%2F%2Fheroin.palmbeachpost.com%2Fpurdue-pharma-plants-seeds-of-opioid-epidemic%2F&tbnid=XfiWgNwfkIqG7M&vet=12ahUKEwjIm7-jxOH2AhXuD1kFHalGBSMQMygAegQIARAe..i&docid=S54YAtNL9c10GM&w=1490&h=443&q=oxycontin%20smiley%20face%20pain%20card&ved=2ahUKEwjIm7-jxOH2AhXuD1kFHalGBSMQMygAegQIARAe |
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Post by stevil on Mar 25, 2022 11:46:12 GMT -5
Do we really need more research? I would say yes, simply because I have tried to give lectures on the superiority of Afrezza and have found that it is more of a theoretical exercise than a proven one. There is a gross lack of convincing evidence for its use. The best they have is the STAT trial and that was with, what, a total of 20-something people? No one is going to change protocols based off of an n=20.
Also, again, I am in no way criticizing VDex. The more I learn about them (and Bill) the more I hold them in increasing regard. However, even if they get better results in their clinics, you'd still want to see Afrezza go head-to-head against other insulins and therapies. I believe I have seen it discussed here before, but one of the confounding factors of their success may be sample bias. It looks like VDex gives phenomenal personalized care to each of their patients. You would expect an improvement in quality metrics. It needs to be shown that it truly is Afrezza that is the cause of VDex's success, APART from that personalized care in order to sway opinions. You also have to consider the possible bias with clientele who seek care at a specialized treatment center. They are clearly concerned about their health and are motivated to change it. Unfortunately, this is not the norm in my experience with maybe up to half or more of those suffering from the disease. I agree with aged back when he/she said that people with diabetes don't want to think about their disease any more than they have to.
You could possibly make the case for Afrezza to be used as first line in the type of environment that offers close follow up and personalized care, but until it uses "real world examples" and has been proven to be more effective while maintaining safety (this will be the biggest boon to its success) it won't be changing anyone's minds. This is not meant to be critical of you or condescending in any way... I don't know how else to say it, so please forgive me. I don't think you realize how many assumptions you make regarding the safety and efficacy of Afrezza. I don't disagree with your assumptions but you have to realize that they are assumptions. Not everyone makes life/death decisions on assumptions, especially if they don't have to. I feel comfortable enough with what I know of Afrezza to prescribe it. I also understand why others may not feel that way and don't fault them for it. Hopefully MNKD has designed these new peds and India trials in a way that can showcase the true greatness of Afrezza.
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Post by sportsrancho on Mar 25, 2022 11:49:56 GMT -5
From Bill,
“In recognizing the difficulty of changing from the status quo, and the need for data to justify that there is an implicit assumption that the status quo is good, we don’t want to change from “good” to “better” unless the data says so. This is prudent.
But this is NOT the situation in diabetes.
Current care is NOT GOOD. In that case when something seems like it might be better, even if one doesn’t have full-blown data to support it, it’s highly worth looking into.
That’s my issue with diabetes and the treating doctors today. When you can’t get a patient’s A1c below 9 with all the various drugs and someone comes along making the case that you can get the person down to 6 safely, what have you got to lose?! An A1c of 9 will kill that patient. Try something?! For Gods sake!”
I had no specific reason to post this here, there were two threads going on so I just picked a spot.
More later…we are short on time:-)
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Post by stevil on Mar 25, 2022 11:55:47 GMT -5
From Bill, “In recognizing the difficulty of changing from the status quo, and the need for data to justify that there is an implicit assumption that the status quo is good, we don’t want to change from “good” to “better” unless the data says so. This is prudent. But this is NOT the situation in diabetes. Current care is NOT GOOD. In that case when something seems like it might be better, even if one doesn’t have full-blown data to support it, it’s highly worth looking into. That’s my issue with diabetes and the treating doctors today. When you can’t get a patient’s A1c below 9 with all the various drugs and someone comes along making the case that you can get the person down to 6 safely, what have you got to lose?! An A1c of 9 will kill that patient. Try something?! For Gods sake!” I had no specific reason to post this here, there were two threads going on so I just picked a spot. More later…we are short on time:-) I agree with Bill wholly. The issue is with this comment, "When you can’t get a patient’s A1c below 9 with all the various drugs and someone comes along making the case that you can get the person down to 6 safely". Afrezza hasn't been shown to be able to do this yet. I agree that once it does, things will change. Unfortunately, unless I'm terrible at looking for this data, it doesn't exist in a respected and peer-reviewed journal- which is the kind of publication required to make changes in practicing habits. And to be fully clear and transparent, Bill has been gracious enough to agree to my request to teach me how to use Afrezza so that I can be able to do this myself. It's my hope that I'll be able to run my own small trial with my patients and submit it for publication at some point if the data is still lacking. |
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Post by sayhey24 on Mar 25, 2022 13:09:15 GMT -5
Do we really need more research? I would say yes, simply because I have tried to give lectures on the superiority of Afrezza and have found that it is more of a theoretical exercise than a proven one. There is a gross lack of convincing evidence for its use. The best they have is the STAT trial and that was with, what, a total of 20-something people? No one is going to change protocols based off of an n=20. Also, again, I am in no way criticizing VDex. The more I learn about them (and Bill) the more I hold them in increasing regard. However, even if they get better results in their clinics, you'd still want to see Afrezza go head-to-head against other insulins and therapies. I believe I have seen it discussed here before, but one of the confounding factors of their success may be sample bias. It looks like VDex gives phenomenal personalized care to each of their patients. You would expect an improvement in quality metrics. It needs to be shown that it truly is Afrezza that is the cause of VDex's success, APART from that personalized care in order to sway opinions. You also have to consider the possible bias with clientele who seek care at a specialized treatment center. They are clearly concerned about their health and are motivated to change it. Unfortunately, this is not the norm in my experience with maybe up to half or more of those suffering from the disease. I agree with aged back when he/she said that people with diabetes don't want to think about their disease any more than they have to. You could possibly make the case for Afrezza to be used as first line in the type of environment that offers close follow up and personalized care, but until it uses "real world examples" and has been proven to be more effective while maintaining safety (this will be the biggest boon to its success) it won't be changing anyone's minds. This is not meant to be critical of you or condescending in any way... I don't know how else to say it, so please forgive me. I don't think you realize how many assumptions you make regarding the safety and efficacy of Afrezza. I don't disagree with your assumptions but you have to realize that they are assumptions. Not everyone makes life/death decisions on assumptions, especially if they don't have to. I feel comfortable enough with what I know of Afrezza to prescribe it. I also understand why others may not feel that way and don't fault them for it. Hopefully MNKD has designed these new peds and India trials in a way that can showcase the true greatness of Afrezza. Stevil - I would suggest you change your lecture approach. People like to be entertained. There is nothing like a real live demo - "Seeing is Believing". The thing about afrezza is its pretty repeatable in T2s who are not on other antiglycemics. One demo is the Coke Challenge. This can be done showing CGM results without afrezza and then a live demo with afrezza with one person. Another is to have two PWDs side by side which is more fun and what I would suggest Mike do at the 82nd ADA get together in June. As far as making assumptions about the safety and efficacy of afrezza, I am going by what Al Mann said and I believe what he said. Since its approval the only thing I have seen is it has probably exceeded his expectations. Our VDex friends seem to also view it as extremely safe. One thing we do know is that for a T2 on no other meds you really have to try to get a severe hypo. Thats another demo you can do for your lecture. Take a non-diabetic and have them take a small (4u) afrezza and watch the CGM bottom and then the BG flatten out. VDex I think has this in one of their papers. I also don't think MNKD needs to convince the entire world at once. Mike's targeted GP campaign starting with some big GP corporations I think is a great approach but he needs industry "experts" saying CGMs and afrezza first. He needs an official care guide. The way Perdue did this was they made up their own "expert" organizations who just started saying if you have pain take OC. In the case of MNKD they need something for the June campaign and maybe the right approach is AACE support. I don't think the AACE is currently in the T2 space. This seems like the perfect fit. They are already saying CGMs first, AGPs first. Maybe Mike should be calling them this afternoon and see if they would endorse a new SoC protocol and card. He probably knows George Grunberger. Why Dave Kendall did not call him seems like a mystery. Maybe he did but regardless Mike needs to stop playing with the ADA and make the market himself. Whether its remaking the AACE or starting a new organization we need a new simple SoC to market to the GPs. We already have numerous companies playing in the monitoring space. How to put a CGM, afrezza and a monitoring service as a bundle and how it gets paid for is something Mike needs to work out. There are a bunch of monitoring company including the diet companies like Nutrisense. However, if the new SoC is saying this is the way T2s should be treated then the insurance companies will start listening once a few lawsuits are issued. |
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Post by sayhey24 on Mar 25, 2022 13:36:20 GMT -5
From Bill, “In recognizing the difficulty of changing from the status quo, and the need for data to justify that there is an implicit assumption that the status quo is good, we don’t want to change from “good” to “better” unless the data says so. This is prudent. But this is NOT the situation in diabetes. Current care is NOT GOOD. In that case when something seems like it might be better, even if one doesn’t have full-blown data to support it, it’s highly worth looking into. That’s my issue with diabetes and the treating doctors today. When you can’t get a patient’s A1c below 9 with all the various drugs and someone comes along making the case that you can get the person down to 6 safely, what have you got to lose?! An A1c of 9 will kill that patient. Try something?! For Gods sake!” I had no specific reason to post this here, there were two threads going on so I just picked a spot. More later…we are short on time:-) I agree with Bill wholly. The issue is with this comment, "When you can’t get a patient’s A1c below 9 with all the various drugs and someone comes along making the case that you can get the person down to 6 safely". Afrezza hasn't been shown to be able to do this yet. I agree that once it does, things will change. Unfortunately, unless I'm terrible at looking for this data, it doesn't exist in a respected and peer-reviewed journal- which is the kind of publication required to make changes in practicing habits. And to be fully clear and transparent, Bill has been gracious enough to agree to my request to teach me how to use Afrezza so that I can be able to do this myself. It's my hope that I'll be able to run my own small trial with my patients and submit it for publication at some point if the data is still lacking. Stevil - the big safety issue is making sure the other antiglycemics these patients may be on do not cause harm or produce unexpected afrezza results. I sure hope you take Bill up on his offer. Starting with a new 9+ T2 with few other medical issue and learning from there is a good approach. Or course you will want to actively monitor them with Abbotts system. The key in reducing A1c is stopping the post meal spike and getting the PWD back to baseline under 2 hours. Thats what afrezza does and only afrezza does that. Why you say afrezza hasn't been shown to be able to do this yet is a head scratcher. Afrezza has been doing this even when its under prescribed like the label says to do. VDex and now Mike have learned is you go big with afrezza dosing. If VDex doesn't work out another approach is to team with Nutrisense as a partner and have them do the monitoring. www.nutrisense.io/nutrisense-partners The one advantage is they have a very active nutritionist. The disadvantage is it will cost $200 for the intro package and they still think they can solve all post meal spikes through diet. Even Richard Bernstein who nearly starved himself was not 100% successful and others like Jenny Ruhl tried and tried until the T2 progressed. Speaking of peer reviewed journals. If you had an "official" SoC card saying step 1 CGMs, AGP and afrezza you would not need to be searching these journals. I just love reading Ralph DeFronzo's peer reviewed studies which prop up GLP1s. When you can see the results real-time and it is repeatable and you have the "official" treatment card there is no need for bogus peer reviewed studies always saying we need more research. |
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Post by buyitonsale on Mar 26, 2022 0:56:52 GMT -5
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Post by sayhey24 on Mar 26, 2022 7:42:23 GMT -5
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Post by cjm18 on Mar 26, 2022 15:01:54 GMT -5
The Ada doesn’t want to endorse anything or anyone in diabetes treatment. They would rather be neutral and just say eat this. Not that. They are essentially recommending a low fat (fear of cholesterol) and and low carb (but no fear of fructose). It’s starvation and hard to keep up when you are hungry all the time due to low calories and blood sugar spikes from fruit. Type 2 Diabetes is reversible if you treat the insulin resistance. Insulin treats the blood sugars but not the insulin resistance. Treat insulin resistance by keeping insulin low. Keep insulin low by eating keto (fat does not spike insulin) and eat one meal a day or two in 8 hours. The Ada should endorse the work of Dr Jason Fung without naming him. Just name keto and intermittent fasting as treatments that might work but need more research. |
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Post by buyitonsale on Mar 26, 2022 22:47:55 GMT -5
Yes, T2D is.100% reversible, get used to it. It is not common knowledge unfortunately but it will be when enough people get tired of being sick and tired,
Now back to Afrezza, best mealtime insulin on the market.
How do you get it into hands of patients ?
Not easy…
Doctors control prescriptions.
Insurance companies control doctors.
Big drug companies control insurance companies.
The system is designed to control drug cost, not outcomes. But diabetes management costs are rising and the big winners are big pharma.
When insurance companies get tired of loosing the diabetes battle and figure out that diabetes management cost are related to time in range and better prandial glucose control then perhaps Afrezza will be in the spotlight it deserves.
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Post by prcgorman2 on Mar 27, 2022 9:46:53 GMT -5
Aged once said that insurance companies do not take a long view because of the amount of time a particular insured person is with one provider or another. There wasn’t evidence to back it up, but my personal experience gave me the gut feeling Aged is right. That and there is a large insurance company in our area and I’ve talked with folks. Whatever else they may say, they’re not about managing health. They’re about managing costs; THEIR costs, not the patient’s. For Afrezza’s life-changing qualities to be recognized as saving limbs, lives, and most importantly, COSTS, it has to come from a consortium of insurers, or get one or two really big insurers to agree they’re ping-ponging patients amongst them and Afrezza can help the consortium. My guess is a discussion along those lines would be a unique first, and perhaps too close to violating anti-trust laws. I don’t expect that to happen.
Stevil had it right, and some may remember that I’ve banged this gong more than once. And to borrow a phrase from James Carville, “It’s THE SAFETY, stupid!”
Prove, in spectacularly convincing fashion, in a peer reviewed journal, that Afrezza’s safety with respect to managing TIR is unimpeachable and unattainable otherwise, and you will catch the attention of insulin-prescribers
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Post by sayhey24 on Mar 27, 2022 12:03:52 GMT -5
The Ada doesn’t want to endorse anything or anyone in diabetes treatment. They would rather be neutral and just say eat this. Not that. They are essentially recommending a low fat (fear of cholesterol) and and low carb (but no fear of fructose). It’s starvation and hard to keep up when you are hungry all the time due to low calories and blood sugar spikes from fruit. Type 2 Diabetes is reversible if you treat the insulin resistance. Insulin treats the blood sugars but not the insulin resistance. Treat insulin resistance by keeping insulin low. Keep insulin low by eating keto (fat does not spike insulin) and eat one meal a day or two in 8 hours. The Ada should endorse the work of Dr Jason Fung without naming him. Just name keto and intermittent fasting as treatments that might work but need more research. The ADA is clearly endorsing GLP1s now and then SGLT2s because those BPs showed them the money. Unlike the AACP which says new diabetics should be using CGMs, thats the last thing the ADA wants when promoting metformin then GLP1s and SGLT2s. Its hard to hide from the real post prandial CGM numbers and then try to explain what these drugs are doing to help that spike. What exactly is "insulin resistance". Why is it if a T2 takes afrezza before the BG shoots up and before the pancreas is trying to release its insulin, the T2 needs significantly less insulin? After the BG shoots up, you would think since the pancreas has already released what it had, you would already have some insulin boost and you would need less. Joslin did some lost research on this years ago but I have seen some similar research now with Covid. The theory is in addition to killing beta cells the virus is corrupting the insulin being released by the pancreas and while it attaches to the insulin receptors its not working properly. That attached faux-insulin is then blocking the insulin receptors for exogenous insulin giving what we see as "insulin resistance". If this new covid research is correct then using afrezza as a front line treatment makes a lot of sense. Not only does it block the "insulin resistance" but it also takes the load off the pancreas to produce more insulin which allows regeneration of beta cells. Maybe this covid research is correct, maybe not. It makes sense to me. What we do know is we are seeing a big rise in T2 after covid. We also now Joslin isolated at least four viruses years ago which cause T2. We also know early use of insulin has shown to stop and even reverse T2. I have reviewed Jason Fung's work a while back. I am not a fan. I am also not a fan of the Bernstein diet when you have afrezza. What fasting and keto do is reduce the need for the body to produce phase 1 insulin. Its taking the load off the pancreas which promotes beta cell regeneration. Afrezza does the same thing or I would argue much better with much less pain. |
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Post by agedhippie on Mar 27, 2022 15:21:50 GMT -5
Aged once said that insurance companies do not take a long view because of the amount of time a particular insured person is with one provider or another. There wasn’t evidence to back it up, but my personal experience gave me the gut feeling Aged is right. That and there is a large insurance company in our area and I’ve talked with folks. Whatever else they may say, they’re not about managing health. They’re about managing costs; THEIR costs, not the patient’s. For Afrezza’s life-changing qualities to be recognized as saving limbs, lives, and most importantly, COSTS, it has to come from a consortium of insurers, or get one or two really big insurers to agree they’re ping-ponging patients amongst them and Afrezza can help the consortium. My guess is a discussion along those lines would be a unique first, and perhaps too close to violating anti-trust laws. I don’t expect that to happen. Stevil had it right, and some may remember that I’ve banged this gong more than once. And to borrow a phrase from James Carville, “It’s THE SAFETY, stupid!” Prove, in spectacularly convincing fashion, in a peer reviewed journal, that Afrezza’s safety with respect to managing TIR is unimpeachable and unattainable otherwise, and you will catch the attention of insulin-prescribers Insurance companies are about taking bets whether it's household, car, or pet insurance. They are betting that during the term of your policy, typically the next year, they will charge you more than they spend. The evidence is in the existence actuarial science which exists to let companies frame those bets. If you want to know how long the insurance company is looking ahead then look at the term of your insurance, and anything beyond that term is irrelevant to them. Could they collude, anti-trust aside? Yes, but why bother. Ultimately that bill will be picked up by Medicare and Medicaid rather than the insurer. You don't just need to change the SoC, you need to change the way the whole US health system is funded. As to changing the SoC, that's the same as it ever was - large scale clinical trials or go home! |
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Post by sportsrancho on Mar 27, 2022 15:34:19 GMT -5
Aged once said that insurance companies do not take a long view because of the amount of time a particular insured person is with one provider or another. There wasn’t evidence to back it up, but my personal experience gave me the gut feeling Aged is right. That and there is a large insurance company in our area and I’ve talked with folks. Whatever else they may say, they’re not about managing health. They’re about managing costs; THEIR costs, not the patient’s. For Afrezza’s life-changing qualities to be recognized as saving limbs, lives, and most importantly, COSTS, it has to come from a consortium of insurers, or get one or two really big insurers to agree they’re ping-ponging patients amongst them and Afrezza can help the consortium. My guess is a discussion along those lines would be a unique first, and perhaps too close to violating anti-trust laws. I don’t expect that to happen. Stevil had it right, and some may remember that I’ve banged this gong more than once. And to borrow a phrase from James Carville, “It’s THE SAFETY, stupid!” Prove, in spectacularly convincing fashion, in a peer reviewed journal, that Afrezza’s safety with respect to managing TIR is unimpeachable and unattainable otherwise, and you will catch the attention of insulin-prescribers Insurance companies are about taking bets whether it's household, car, or pet insurance. They are betting that during the term of your policy, typically the next year, they will charge you more than they spend. The evidence is in the existence actuarial science which exists to let companies frame those bets. If you want to know how long the insurance company is looking ahead then look at the term of your insurance, and anything beyond that term is irrelevant to them. Could they collude, anti-trust aside? Yes, but why bother. Ultimately that bill will be picked up by Medicare and Medicaid rather than the insurer. You don't just need to change the SoC, you need to change the way the whole US health system is funded. As to changing the SoC, that's the same as it ever was - large scale clinical trials or go home! And there you go, all you have to read is the 2 above posts. Studies Published in journals/ Doctors Dosing Insurance In addition people will keep trying if their insurance denies It, they will not keep trying if they have a bad experience. |
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