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Post by sayhey24 on Mar 24, 2022 10:44:26 GMT -5
Stevil said in another thread "Afrezza will have its greatest benefit in pediatric patients and newer-ish diagnosed DM patients who have not yet developed complications from the disease. It will be far more effective in preventing comorbid conditions than any other medication." I couldn't agree more. So how does MNKD get the new DM on afrezza first and not last? Is it really all about the SoC? Is the ADA the only gatekeeper? If step 1 of the SoC was to give the new PWD a CGM and based on their AGP results step 2 would be to add afrezza, would that change how doctor's prescribed afrezza? Would that force insurance to cover it? Would this change reduce PWD complications from developing? Does the SoC not only dictate what the doctor should prescribe but if insurance will cover it? In the age of CGMs why wouldn’t the SoC recommend all newly diagnosed T2s get at least a 2 week AGP but probably 6 months? We have diet companies like Levels and Nutrisense pushing CGM’s for diet control. Why do CGM's require a prescription? They don't in the EU. Why is the ADA the only diabetes organization publishing a doctor’s diabetic guide for care? Does it have to be? It doesn’t seem the ADA has any competition and I don’t think the SoC is very good. That SoC card is just so convoluted and IMO could be simplified by adding CGMs and afrezza. I don't even see CGMs mentioned. Here is a picture pbs.twimg.com/media/Du4s6lMWwAEqm5r.jpg:largeWho gave the ADA this power? It seems to me its time for a new organization publishing a new doctor’s guide promoting the early use of CGM’s and afrezza. Maybe Dave Kendall’s approach of working with the ADA to change the SoC after getting stonewalled was the wrong approach. Maybe Dave should have started a new association. Does the ADA have any competition with a doctor's guide? What if they did? It sure would be nice to hand out a simple card during Mike's "Seeing is Believing" campaign to have a simple prescribing guide which highlights the CGM and afrezza use to hand out to the GPs. |
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Post by radgray68 on Mar 24, 2022 11:15:47 GMT -5
Show ANYBODY the slide from Mike's presentation that shows the 79% not at goal and the reasonable person would throw away the current, so-called "standard of care."
S E V E N T Y N I N E F R E A K I N G P E R C E N T !!!!!!!
I don't like to be cynical, well, not always. However, the only puzzle piece that fits this scenario is somebody's paid off to look the other way. As I get older and more inequities show up in life, I can almost see strings behind all the puppets. It's saddening but the Bible was right: "He who increases knowledge, increases sorrow."
Not sure how we're going to get through this quagmire, but I personally do not put ANY hopes on the ADA, the FDA or their ridiculous current "standard of care"
p.s. Sorry if the all caps sections offend. It's merely to illustrate the points I'm screaming about in my head ("This is your captain speaking, I will get you there safely 21 percent of the time.")
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Post by mango on Mar 24, 2022 12:06:13 GMT -5
Stevil said in another thread "Afrezza will have its greatest benefit in pediatric patients and newer-ish diagnosed DM patients who have not yet developed complications from the disease. It will be far more effective in preventing comorbid conditions than any other medication." I couldn't agree more. So how does MNKD get the new DM on afrezza first and not last? Is it really all about the SoC? Is the ADA the only gatekeeper? If step 1 of the SoC was to give the new PWD a CGM and based on their AGP results step 2 would be to add afrezza, would that change how doctor's prescribed afrezza? Would that force insurance to cover it? Would this change reduce PWD complications from developing? Does the SoC not only dictate what the doctor should prescribe but if insurance will cover it? In the age of CGMs why wouldn’t the SoC recommend all newly diagnosed T2s get at least a 2 week AGP but probably 6 months? We have diet companies like Levels and Nutrisense pushing CGM’s for diet control. Why do CGM's require a prescription? They don't in the EU. Why is the ADA the only diabetes organization publishing a doctor’s diabetic guide for care? Does it have to be? It doesn’t seem the ADA has any competition and I don’t think the SoC is very good. That SoC card is just so convoluted and IMO could be simplified by adding CGMs and afrezza. I don't even see CGMs mentioned. Here is a picture pbs.twimg.com/media/Du4s6lMWwAEqm5r.jpg:largeWho gave the ADA this power? It seems to me its time for a new organization publishing a new doctor’s guide promoting the early use of CGM’s and afrezza. Maybe Dave Kendall’s approach of working with the ADA to change the SoC after getting stonewalled was the wrong approach. Maybe Dave should have started a new association. Does the ADA have any competition with a doctor's guide? What if they did? It sure would be nice to hand out a simple card during Mike's "Seeing is Believing" campaign to have a simple prescribing guide which highlights the CGM and afrezza use to hand out to the GPs. A couple years ago I was seriously considering doing something similar. It was going to be a diabetes association for veterans and I went so far as to contacting a company to do the paperwork and filing, trademarks, nonprofit setup, etc. At the end of the day it proved to be more involved than I could take on during my spare time so I abandoned the concept before I put any money into it. I think it is a brilliant and logical move. I've always believed Vdex and/or MannKind should develop their own SoC and start doing publications on it. The SoC does not work, it's proven year after year, yet it and ADA are never held accountable. I hope someone creates what you're talking about. AND SOON. |
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Post by stevil on Mar 24, 2022 12:31:40 GMT -5
Is the ADA the only gatekeeper? If step 1 of the SoC was to give the new PWD a CGM and based on their AGP results step 2 would be to add afrezza, would that change how doctor's prescribed afrezza? Would that force insurance to cover it? Would this change reduce PWD complications from developing? Does the SoC not only dictate what the doctor should prescribe but if insurance will cover it? In the age of CGMs why wouldn’t the SoC recommend all newly diagnosed T2s get at least a 2 week AGP but probably 6 months? We have diet companies like Levels and Nutrisense pushing CGM’s for diet control. Why do CGM's require a prescription? They don't in the EU. Why is the ADA the only diabetes organization publishing a doctor’s diabetic guide for care? Does it have to be? It doesn’t seem the ADA has any competition and I don’t think the SoC is very good. That SoC card is just so convoluted and IMO could be simplified by adding CGMs and afrezza. I don't even see CGMs mentioned. Here is a picture pbs.twimg.com/media/Du4s6lMWwAEqm5r.jpg:largeWho gave the ADA this power? It seems to me its time for a new organization publishing a new doctor’s guide promoting the early use of CGM’s and afrezza. Maybe Dave Kendall’s approach of working with the ADA to change the SoC after getting stonewalled was the wrong approach. Maybe Dave should have started a new association. Does the ADA have any competition with a doctor's guide? What if they did? It sure would be nice to hand out a simple card during Mike's "Seeing is Believing" campaign to have a simple prescribing guide which highlights the CGM and afrezza use to hand out to the GPs. No, but they do have a lot of influence. See below. If step 1 of the SoC was to give the new PWD a CGM and based on their AGP results step 2 would be to add afrezza, would that change how doctor's prescribed afrezza? Most likely Would that force insurance to cover it? I actually don't know this for sure, but I don't think insurance companies are forced to cover anything. I believe they choose to have more generous offerings due to the free market. Meaning if their plan sucks at covering medications, people won't want to pay for it. Someone can correct me if I'm wrong. Would this change reduce PWD complications from developing? Only way to know for sure is to have retrospective studies evaluating complications and outcomes of those on Afrezza vs SOC. Does the SoC not only dictate what the doctor should prescribe but if insurance will cover it? There is a bit of nuance to this question. You have variation in medicine depending on both doctors and physicians. As a general rule, most doctors (evidence-based, anyway) prescribe and insurance companies cover the SOC. It is far more the rule than the exception. However, some physicians deviate from "guidelines" because they are don't see their patients as a whole of a population the SOC is based on but as an individual who may have needs different than "normal". You also have less restrictive insurance companies that are more generous in their benefits... if you're able to afford them. You get what you pay for. Why wouldn’t the SoC recommend all newly diagnosed T2s get at least a 2 week AGP? Most often, it's not necessary. Unless someone avoids their doctors like the plague, they'll usually seek medical advice when they start noticing they're peeing 2-3 times an hour and can't satiate their thirst. People usually get caught early enough that they don't need to be put on insulin right away, at least according to current "guidelines". For those that do get caught with severe disease, they do get started on insulin right away, and, in theory, you could prescribe them a CGM, but generally anyone that goes on insulin gets prescribed a glucometer and test strips and is told to test as much or as little as they're willing to. I'll respond to others as I have time... Gotta run. |
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Post by robbmo on Mar 24, 2022 12:31:59 GMT -5
Show ANYBODY the slide from Mike's presentation that shows the 79% not at goal and the reasonable person would throw away the current, so-called "standard of care." S E V E N T Y N I N E F R E A K I N G P E R C E N T !!!!!!! I don't like to be cynical, well, not always. However, the only puzzle piece that fits this scenario is somebody's paid off to look the other way. As I get older and more inequities show up in life, I can almost see strings behind all the puppets. It's saddening but the Bible was right: "He who increases knowledge, increases sorrow." Not sure how we're going to get through this quagmire, but I personally do not put ANY hopes on the ADA, the FDA or their ridiculous current "standard of care" p.s. Sorry if the all caps sections offend. It's merely to illustrate the points I'm screaming about in my head ("This is your captain speaking, I will get you there safely 21 percent of the time.") Reminds me of a quote by Upton Sinclair: “It is difficult to get a man to understand something, when his salary depends on his not understanding it.” |
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Post by hopingandwilling on Mar 24, 2022 13:44:38 GMT -5
Radgray,
I respectfully submit to you that you aren’t looking at the 79% in the proper context.
1) Many diabetics due to a multitude of reasons don’t use any medication for their condition—so when they visit a doctor their records will reflect that their condition is not under control.
2) Say they are using regular insulin many can’t afford it, so they are failing to properly dose it when needed–therefore, when they see their doctor, they are counted in the 79% group.
3) Go to a shopping mall or restaurant—find a seat that you can watch the crowd for just an hour ---what do you see! Massively obese people---where there is a constant battle of using insulin and the comorbidity issues they are suffering. You can’t drink a Big Gulp every hour and think your blood glucose levels will remain normal. Eating a double-cheese burger every day with an order of French fries---what should one think about their blood glucose levels after such events?
4) Humans must meet health science options in the middle of the equation of healthy living habits. Merely having a pill, injection or inhaler can’t solve our healthcare issues.
This list of comparator issues causing the pandemic of diabetes around the world can’t be solved just by using insulin---of any type!
But the solution you suggest—is a red herring and I’m not talking about a fish. The fact of the matter should Afrezza becomes the SOC, you can’t ignore the fact that thousands of diabetics have had and have used Afrezza as a medication for their diabetic condition—and covered by insurance. Yet, more than 80% of them refuse to get their prescriptions refilled. Do you understand what you are suggesting---you want to swap 79% for 80%?
Effective healthcare treatment options are essential for us humans. Whether they come from MannKind or any other drug company. I owned shares of Nektar(Exubera) and I owned shares of MannKind---I don’t own their shares now. I might be stupid---but when I see a drug being used by patients and see that 80% of them stop using it and obviously go back to their previous drug---that impacts my thinking about how effective that drug was working for them.
Until MannKind can figure out what is causing this refusal to refill a patient’s initial prescription merely getting Afrezza listed as a SOC isn’t going to resolve the problem. I hope they can accomplish this needed achievement for making Afrezza a success story for diabetics.
You now have permission to ignore or attack what I've posted!
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Post by sayhey24 on Mar 24, 2022 13:50:11 GMT -5
stevil - thanks for the answers. Let me start with your last
Why wouldn’t the SoC recommend all newly diagnosed T2s get at least a 2 week AGP? "Most often, it's not necessary. Unless someone avoids their doctors like the plague, they'll usually seek medical advice when they start noticing they're peeing 2-3 times an hour and can't satiate their thirst. People usually get caught early enough that they don't need to be put on insulin right away, at least according to current "guidelines". For those that do get caught with severe disease, they do get started on insulin right away, and, in theory, you could prescribe them a CGM, but generally anyone that goes on insulin gets prescribed a glucometer and test strips and is told to test as much or as little as they're willing to."
I think one of the major goals of this new association needs to be to change this thinking. What we do know from many studies is early insulin intervention has dramatic positive results and can stop and reverse diabetes. In other words the current "guidelines" are outdated based on AGPs and afrezza. Without knowing a PWDs 2 hour post prandial glucose profile we are just flying blind.
As an aside - the AGP is the basis for all these new tech diet companies. It seems if diet companies have recognized the importance of post prandial insulin response, doctors should too.
As these diet companies grow I think you are going to start seeing a new breed of PWD. This PWD is going to be coming to you with their AGP from their diet company and they are going to be telling you, I have diabetes. When they get prescribed metformin and it does nothing to change their post meal spike they are going to throw it in the trash and tell you to address the post meal spike.
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Post by hellodolly on Mar 24, 2022 13:54:52 GMT -5
Show ANYBODY the slide from Mike's presentation that shows the 79% not at goal and the reasonable person would throw away the current, so-called "standard of care." S E V E N T Y N I N E F R E A K I N G P E R C E N T !!!!!!! I don't like to be cynical, well, not always. However, the only puzzle piece that fits this scenario is somebody's paid off to look the other way. As I get older and more inequities show up in life, I can almost see strings behind all the puppets. It's saddening but the Bible was right: "He who increases knowledge, increases sorrow." Not sure how we're going to get through this quagmire, but I personally do not put ANY hopes on the ADA, the FDA or their ridiculous current "standard of care" p.s. Sorry if the all caps sections offend. It's merely to illustrate the points I'm screaming about in my head ("This is your captain speaking, I will get you there safely 21 percent of the time.") Reminds me of a quote by Upton Sinclair: “It is difficult to get a man to understand something, when his salary depends on his not understanding it.” Sounds like a quote right out of "The Jungle". Poor Jurgis had no idea how his life would become a living hell. One of my favorite Sinclair novels of all time. |
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Post by radgray68 on Mar 24, 2022 14:00:54 GMT -5
1. I have discussed the apathy I see in the patient’s attitude during weekly X-ray exams I take on diabetic foot ulcers…..in a different thread.
2. Everybody’s known that Afrezza’s dosing is WAY too low to show the benefits of Al’s monomers. Afrezzauser and the original adopters told us that. Have you not listened to the trials and the changes in protocol we’ve been studying and testing? Without much cash and All current dosing is what was guided by the FDA btw.
3. I wasn’t putting my opinion up for debate. It’s a fact. Any reasonable person would throw out the current SOC
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Post by mango on Mar 24, 2022 14:03:15 GMT -5
The new association should make it a priority to address the issue of prescribing medically incorrect treatments for the disease. People with T2D have a diminished or loss of the first phase insulin response. Currently, only Afrezza addresses this, and is technically the only medically correct treatment for T2D as it addresses the root of what is causing dysregulation in glucose homeostasis (unless you are allergic to fdkp or polysorbate 80).
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Post by stevil on Mar 24, 2022 14:33:03 GMT -5
In the age of CGMs why wouldn’t the SoC recommend all newly diagnosed T2s get at least a 2 week AGP but probably 6 months? We have diet companies like Levels and Nutrisense pushing CGM’s for diet control. Why do CGM's require a prescription? They don't in the EU. Why is the ADA the only diabetes organization publishing a doctor’s diabetic guide for care? Does it have to be? It doesn’t seem the ADA has any competition and I don’t think the SoC is very good. That SoC card is just so convoluted and IMO could be simplified by adding CGMs and afrezza. I don't even see CGMs mentioned. Here is a picture pbs.twimg.com/media/Du4s6lMWwAEqm5r.jpg:largeWho gave the ADA this power? It seems to me its time for a new organization publishing a new doctor’s guide promoting the early use of CGM’s and afrezza. Maybe Dave Kendall’s approach of working with the ADA to change the SoC after getting stonewalled was the wrong approach. Maybe Dave should have started a new association. Does the ADA have any competition with a doctor's guide? What if they did? It sure would be nice to hand out a simple card during Mike's "Seeing is Believing" campaign to have a simple prescribing guide which highlights the CGM and afrezza use to hand out to the GPs. This one makes sense to me but only in the context of insurance coverage. Patient's who want to purchase their own outside of their insurance should not be restricted. Must be a liability issue in case they develop infection? Maybe they need someone to show them how to install it? Why is the ADA the only diabetes organization publishing a doctor’s diabetic guide for care? They're not. There are several. Here are just a few others. pro.aace.com/disease-state-resources/diabetes/clinical-practice-guidelines-treatment-algorithms/new-2021www.ihs.gov/diabetes/clinician-resources/dm-treatment-algorithms/www.dshs.texas.gov/txdiabetes/toolkit/Treatment-Algorithms,-Protocols,-Guidelines-and-Recommendations/ Who gave the ADA this power? I'm not sure what power you're talking about. Their guidelines are respected because they have some of the most resources available to compile and analyze data and they have the thought leaders in the field working for them. Even though I don't necessarily agree with their algorithm, I do think it is a good "guideline" when you're not sure how to approach a patient that is new to you. It's a very easy to follow and mostly effective plan. Remember, just because diabetes is worsening, doesn't mean treatment is worsening. Treatment is improving, it's just that the habits that are causing the underlying disease is worsening. The medications we have now are far better than we used to have. It's just the causes of the disease are getting so much worse that the treatments aren't able to keep up. Afrezza might be able to fix this issue, but it remains to be seen that even when given the best tool that people will be compliant with at least 3 puffs a day. In other words, it's not always the treatment that's the issue and a treatment can only be effective if it's used properly. Maybe Dave should have started a new association. What evidence do you think he would be able to present at this new association to garner respect from his colleagues and peers? |
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Post by goyocafe on Mar 24, 2022 14:55:25 GMT -5
ADA - Afrezza Diabetes Association
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Post by sayhey24 on Mar 24, 2022 14:58:48 GMT -5
Radgray, I respectfully submit to you that you aren’t looking at the 79% in the proper context. 1) Many diabetics due to a multitude of reasons don’t use any medication for their condition—so when they visit a doctor their records will reflect that their condition is not under control. 2) Say they are using regular insulin many can’t afford it, so they are failing to properly dose it when needed–therefore, when they see their doctor, they are counted in the 79% group. 3) Go to a shopping mall or restaurant—find a seat that you can watch the crowd for just an hour ---what do you see! Massively obese people---where there is a constant battle of using insulin and the comorbidity issues they are suffering. You can’t drink a Big Gulp every hour and think your blood glucose levels will remain normal. Eating a double-cheese burger every day with an order of French fries---what should one think about their blood glucose levels after such events? 4) Humans must meet health science options in the middle of the equation of healthy living habits. Merely having a pill, injection or inhaler can’t solve our healthcare issues. This list of comparator issues causing the pandemic of diabetes around the world can’t be solved just by using insulin---of any type! But the solution you suggest—is a red herring and I’m not talking about a fish. The fact of the matter should Afrezza becomes the SOC, you can’t ignore the fact that thousands of diabetics have had and have used Afrezza as a medication for their diabetic condition—and covered by insurance. Yet, more than 80% of them refuse to get their prescriptions refilled. Do you understand what you are suggesting---you want to swap 79% for 80%? Effective healthcare treatment options are essential for us humans. Whether they come from MannKind or any other drug company. I owned shares of Nektar(Exubera) and I owned shares of MannKind---I don’t own their shares now. I might be stupid---but when I see a drug being used by patients and see that 80% of them stop using it and obviously go back to their previous drug---that impacts my thinking about how effective that drug was working for them. Until MannKind can figure out what is causing this refusal to refill a patient’s initial prescription merely getting Afrezza listed as a SOC isn’t going to resolve the problem. I hope they can accomplish this needed achievement for making Afrezza a success story for diabetics. You now have permission to ignore or attack what I've posted! I appreciate your responses. I do think Covid has shed a new light on the root cause of beta cell destruction. Many years ago Joslin did some really good work on identifying several viruses which caused diabetes. No surprise the work got buried and the T2 industry continued to promote bad food and diet as the leading cause of T2 diabetes. Even WAPO is reporting on the diabetic covid rise - www.msn.com/en-us/news/us/covid-infection-associated-with-a-greater-likelihood-of-type-2-diabetes-according-to-review-of-patient-records/ar-AAVkK0pWith Covid so many seem shocked that many are now getting diabetes and the SARS virus is causing beta cell destruction. What we have known for a very long time is not all obese people are diabetic. We also know from autopsy of the pancreas is these non-diabetic obese people grow mass clumps of beta cells. So, when they drink their Big Gulps their bodies have adapted to be able to release the needed insulin. In diabetic obese they lack large beta cell volume. What we also know from many studies is early use of insulin has had great results in stopping T2 progression. In Dave Kendall's veins of gold I think he had a study or two which showed afrezza stopping and reversing diabetes. I bet if you put Radgrays 79% on a CGM and add afrezza that number would be dramatically reduced. What our new Tech Diet companies are starting to see is their clients are losing 1st phase insulin release and as it gets worse their clients are having a more difficult time keeping their weight under control. They are starting to understand the importance of post prandial glucose response in weight management. I am not sure as you say "many are not taking their medication". I do know many do no testing. I have gone to many T2 education sessions and one common theme is their doctors never told them to get a meter and test daily, let alone after each meal. These people have no idea what is going on because they are getting no feedback. I bet if you put them on a CGM and they do get the feedback things would change. However in the current SoC, thats not what is being promoted for T2s and that has to change. |
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Post by sr71 on Mar 24, 2022 18:08:00 GMT -5
I'm still holding out for it to be named WDA: World Diabetes Association, which I do not think is being used presently by any organization.
The most similar I found was "International Diabetes Federation", which is serves as an consortium of several hundred other diabetes organizations around the planet.
The name also sounds like something out of Star Wars, or Russia, LOL.
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Post by sayhey24 on Mar 25, 2022 8:57:48 GMT -5
Stevil - you may be on to something here Why is the ADA the only diabetes organization publishing a doctor’s diabetic guide for care? They're not. There are several. Here are just a few others. pro.aace.com/disease-state-resources/diabetes/clinical-practice-guidelines-treatment-algorithms/new-2021 www.ihs.gov/diabetes/clinician-resources/dm-treatment-algorithms/www.dshs.texas.gov/txdiabetes/toolkit/Treatment-Algorithms,-Protocols,-Guidelines-and-Recommendations/ 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 oldie but goodie 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? |
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