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Post by sayhey24 on May 12, 2022 14:17:30 GMT -5
The history of this is about 5 years ago Aged's reason for not using afrezza was his endo was convinced afrezza would result in severe lung damage which I now refer to as the "exploding lung" theory. Over time this theory has proven baseless and in some cases PWD lung function has been reported to have improved which is highly unusual in PWDs. The 2007 association to Exubera and their cancer scare has also proven baseless. The FDKP salt is excreted from the body mostly in the urine. Aged said a few months back that he is now experiencing some site absorption issues and mentioned it may be time to try afrezza. Since then Bill from VDex has offered his help but so far Aged does not seem interested. Aged recently mentioned he now has a new endo as his previous endo who had the 'exploding lung" theory got promoted. |
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Post by sayhey24 on May 12, 2022 14:58:39 GMT -5
“We are happy to help him. At the outset let me say from the post it appears his endo, like most, really doesn’t understand Afrezza as well as he thinks he does. If so, he’d know the hypos he mentions really aren’t due to Afrezza. Likely those patients are Type 1 and on basal. It’s the basal that’s the problem. Regardless this is another example of what the marketing of Afrezza is up against.” ~Bill Basal is a very common problem. People tend to partially use basal to cover meals and so take more than they should. Typically this gets uncovered when they move to a pump and the basal testing to set the profiles shows that they are overdosing basal - people almost always wind up on a lower basal rate. Aged - I guess the question is "what is the concern"? For someone not using a basal it is really hard to get a hypo using afrezza. As Bill says above the issue causing the hypo would be the basal and the affect it has on the liver. What we saw from the latest trial at ATTD even 2x the afrezza dose does not cause additional hypos. The basal/afrezza user getting a hypo really needs to be taken on a case by case basis as something is going on with the basal interaction with the liver. Bill is willing to help you through this if you have an issue but the usual case is the T1 should not be seeing more hypos. Maybe your new endo would be interested in learning more about afrezza by being part of this "test" with VDex? |
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Reality
May 16, 2022 17:40:13 GMT -5
Post by agedhippie on May 16, 2022 17:40:13 GMT -5
Basal is a very common problem. People tend to partially use basal to cover meals and so take more than they should. Typically this gets uncovered when they move to a pump and the basal testing to set the profiles shows that they are overdosing basal - people almost always wind up on a lower basal rate. interesting that someone put in his mind the risk of lung cancer... Of course i pointed out there have been no cases reported but of anyone has something more concrete to dispel this bad rumor, please let him know. Just another example of what Afrezza is encountering out there. My endo didn't believe there was a lung cancer risk. I asked because I wondered about using a growth hormone like insulin in the lungs worried me (I have a family history of lung cancer). His concern was fibrosis since they thought they were seeing an association with Exubera before it was withdrawn. That led him to want to hang back from another inhaled insulin since it didn't offer a benefit (just non-inferior remember). AFAIK he only prescribed it for one patient who had very low body fat, but I don't know what happened after that. |
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Reality
May 16, 2022 17:59:48 GMT -5
Post by mikesmilitaria on May 16, 2022 17:59:48 GMT -5
Well Medtronic is embedded in the BOD at MNKD.
Medtronic's pump technology was purchased from Al Mann and is a cash cow.
Afrezza is a perfect companion product when used with the pump.
Afrezza could be a serious threat to the pump downstream.
Afrezza's market share now is nil but could explode with pediatric approval.
If you were the CEO of Medtronic what would you do?
Would you wait and see or would you purchase new proven technology to protect your cash cow and grow your business?
MNKD can't market Afrezza but Medtronic can.
Medtronic has to pull the trigger.
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Post by agedhippie on May 16, 2022 18:23:57 GMT -5
Basal is a very common problem. People tend to partially use basal to cover meals and so take more than they should. Typically this gets uncovered when they move to a pump and the basal testing to set the profiles shows that they are overdosing basal - people almost always wind up on a lower basal rate. Aged - I guess the question is "what is the concern"? For someone not using a basal it is really hard to get a hypo using afrezza. As Bill says above the issue causing the hypo would be the basal and the affect it has on the liver. What we saw from the latest trial at ATTD even 2x the afrezza dose does not cause additional hypos. The basal/afrezza user getting a hypo really needs to be taken on a case by case basis as something is going on with the basal interaction with the liver. Bill is willing to help you through this if you have an issue but the usual case is the T1 should not be seeing more hypos. Maybe your new endo would be interested in learning more about afrezza by being part of this "test" with VDex? You probably ought to look at the data - one of the participants had a level 2 (less than 54, level 1 is less than 70) hypo when the dose was doubled. There is also a Quality Control Review Comment provided by the National Library of Medicine saying that " the number of participants analyzed appears inconsistent with data here or in other parts of the record". Basically the numbers are not consistent. To my mind this isn't a huge deal since I am fairly certain I can see what is meant, but it is not going to inspire doctors with confidence. This is the problem with pilot studies because one person in twenty had a hypo does that mean that 5% of people will get hypos, or is that person an outlier and 1:1,000,000? There is no way to tell. That's before you start talking about errors. There was this trial as well ( clinicaltrials.gov/ct2/show/NCT00747006) where they used a fixed dose and varied the meal. When they halved the carbs all the Type 1 diabetics got hypos and that part was stopped. This was another tiny trial so I don't think it means much. |
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Post by agedhippie on May 16, 2022 18:42:34 GMT -5
Well Medtronic is embedded in the BOD at MNKD. Medtronic's pump technology was purchased from Al Mann and is a cash cow. Afrezza is a perfect companion product when used with the pump. Afrezza could be a serious threat to the pump downstream. Afrezza's market share now is nil but could explode with pediatric approval. If you were the CEO of Medtronic what would you do? Would you wait and see or would you purchase new proven technology to protect your cash cow and grow your business? MNKD can't market Afrezza but Medtronic can. Medtronic has to pull the trigger. No, they really don't. 1) The TIR for the Medtronics 780G is around 76% in the real world. 2) Using a pump and still using manual bolus insulin complicates the pump algorithms and would require Medtronics restarting their 780G trials from scratch (cost and time) 3) One of the big attractions of these pumps is that they reduce the time you have to interact with your diabetes. Adding Afrezza as your bolus insulin wipes that out. 4) Medtronics is doing deals with insurers where they guarantee TIR and side effects. That program has been running for 5 years now so it would appear to be viable for Medtronics. 5) Cost to insurers. They will simply switch patients to other pumps (the Tandem looks pretty nice) rather than pay for a pump and RAA, AND afrezza. I don't particularly like pumps, but I have my insurer pestering me to use a 780G. That is not the case with Afrezza! |
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Post by peppy on May 16, 2022 20:54:45 GMT -5
Well Medtronic is embedded in the BOD at MNKD. Medtronic's pump technology was purchased from Al Mann and is a cash cow. Afrezza is a perfect companion product when used with the pump. Afrezza could be a serious threat to the pump downstream. Afrezza's market share now is nil but could explode with pediatric approval. If you were the CEO of Medtronic what would you do? Would you wait and see or would you purchase new proven technology to protect your cash cow and grow your business? MNKD can't market Afrezza but Medtronic can. Medtronic has to pull the trigger. No, they really don't. 1) The TIR for the Medtronics 780G is around 76% in the real world. 2) Using a pump and still using manual bolus insulin complicates the pump algorithms and would require Medtronics restarting their 780G trials from scratch (cost and time) 3) One of the big attractions of these pumps is that they reduce the time you have to interact with your diabetes. Adding Afrezza as your bolus insulin wipes that out. 4) Medtronics is doing deals with insurers where they guarantee TIR and side effects. That program has been running for 5 years now so it would appear to be viable for Medtronics. 5) Cost to insurers. They will simply switch patients to other pumps (the Tandem looks pretty nice) rather than pay for a pump and RAA, AND afrezza. I don't particularly like pumps, but I have my insurer pestering me to use a 780G. That is not the case with Afrezza! Quote: "My insurer is pestering me to use 780G." Tell me more, why would your insurer pester you to use a pump? Does the insurer make more money for their business when a paying customer uses a pump? Why would your insurer care? Who do you talk to when talking to your insurer? What? Check your blood glucose level? Another 89mg/dl reading? |
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May 17, 2022 16:35:05 GMT -5
Post by agedhippie on May 17, 2022 16:35:05 GMT -5
No, they really don't. 1) The TIR for the Medtronics 780G is around 76% in the real world. 2) Using a pump and still using manual bolus insulin complicates the pump algorithms and would require Medtronics restarting their 780G trials from scratch (cost and time) 3) One of the big attractions of these pumps is that they reduce the time you have to interact with your diabetes. Adding Afrezza as your bolus insulin wipes that out. 4) Medtronics is doing deals with insurers where they guarantee TIR and side effects. That program has been running for 5 years now so it would appear to be viable for Medtronics. 5) Cost to insurers. They will simply switch patients to other pumps (the Tandem looks pretty nice) rather than pay for a pump and RAA, AND afrezza. I don't particularly like pumps, but I have my insurer pestering me to use a 780G. That is not the case with Afrezza! Quote: "My insurer is pestering me to use 780G." Tell me more, why would your insurer pester you to use a pump? Does the insurer make more money for their business when a paying customer uses a pump? Why would your insurer care? Who do you talk to when talking to your insurer? What? Check your blood glucose level? Another 89mg/dl reading? These are insurers, you don't talk to them - they talk to you  The insurer wants me on a Medtronics pump because Medtronics pay them money if my A1c doesn't improve, or if I have to go to hospital. This is a no-brainer from the insurer's point of view; if the treatment doesn't go well the payments from Medtronics more than offset the additional costs, but if it goes well then potentially their costs get reduced. At this point someone is going to say, but Afrezza would reduce their costs. The reply to that from the insurers would be, oh good lets talk penalty payments for those that don't improve. The bigger issue was the one that Dexcom raised in this context when they were asked if they were going to do the same - their pockets are not deep enough. The potential cost is steep. |
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Post by sayhey24 on May 17, 2022 20:24:43 GMT -5
Aged - lets talk penalty payments for those that don't improve. If properly coached that population would be very small. If the PWD does not following the coaching then MNKD would not pay the penalty. Tracking them through the CGM makes this pretty simple.
MNKD is doing the ABC trial right now so lets see how turns out. On the "talk" today Mike seemed positive about it. We will see.
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May 17, 2022 21:06:13 GMT -5
Post by porkini on May 17, 2022 21:06:13 GMT -5
Aged - lets talk penalty payments for those that don't improve. If properly coached that population would be very small. If the PWD does not following the coaching then MNKD would not pay the penalty. Tracking them through the CGM makes this pretty simple. MNKD is doing the ABC trial right now so lets see how turns out. On the "talk" today Mike seemed positive about it. We will see. Great, how about let's not talk, how about you get it done and then we'll talk results. Good luck on your mission! |
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Post by agedhippie on May 19, 2022 7:44:14 GMT -5
Aged - lets talk penalty payments for those that don't improve. If properly coached that population would be very small. If the PWD does not following the coaching then MNKD would not pay the penalty. Tracking them through the CGM makes this pretty simple. MNKD is doing the ABC trial right now so lets see how turns out. On the "talk" today Mike seemed positive about it. We will see. Great, how about let's not talk, how about you get it done and then we'll talk results. Good luck on your mission! To echo Porkini's point; coaching is a non-starter because it requires people to want to be coached. My insurer tries so regularly that I have a rule in my email to auto-delete the messages. I have zero interest in someone telling me how to manage my diabetes - that's my decision. From my observation that is a typical reaction. The sole requirement of the Medtronics deal is that they use a Medtronics pump, no coaching gate, no compliance gate. Insurers expect patients to be non-compliant and are seldom disappointed, especially in the Type 2 market, so any deal conditioned on those is a non-starter. This is about reducing insurers costs, not helping patients. |
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Post by sayhey24 on May 19, 2022 8:29:55 GMT -5
Great, how about let's not talk, how about you get it done and then we'll talk results. Good luck on your mission! To echo Porkini's point; coaching is a non-starter because it requires people to want to be coached. My insurer tries so regularly that I have a rule in my email to auto-delete the messages. I have zero interest in someone telling me how to manage my diabetes - that's my decision. From my observation that is a typical reaction. The sole requirement of the Medtronics deal is that they use a Medtronics pump, no coaching gate, no compliance gate. Insurers expect patients to be non-compliant and are seldom disappointed, especially in the Type 2 market, so any deal conditioned on those is a non-starter. This is about reducing insurers costs, not helping patients. Aged - I think you bring up a good point. You say coaching is a non-starter. This is probably true as Bill from VDex called them in another thread "the let’s say “smarter” as a shorthand, is less likely to believe the highly improbably story that his/her care is exactly the opposite of what it should be". I would say that is true for a lot of endos and experienced T1s. It also creates a distinction for new T1s and many T2s. Guys like Gary Scheiner have made a living coaching new T1s - integrateddiabetes.com/meet-our-staff/I think the T2s are a completely different situation. Many want the coaching but they have no idea what to do. They see the GP for 15 minutes, given a script for metformin and told to start losing some weight and take a walk. As time goes on they get worse. Their family is constantly bugging them and they do their best to ignore them. If you go to educational clinics for T2s you would think it is almost entirely a female disease as these sessions will usually be 80% female. The properly funded and marketed T2 coaching service which can stop progression has some potential. |
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Post by stevil on May 19, 2022 8:59:02 GMT -5
People on insulin progress in their disease as well….
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Post by agedhippie on May 20, 2022 14:03:35 GMT -5
Aged - I think you bring up a good point. You say coaching is a non-starter. This is probably true as Bill from VDex called them in another thread "the let’s say “smarter” as a shorthand, is less likely to believe the highly improbably story that his/her care is exactly the opposite of what it should be". I would say that is true for a lot of endos and experienced T1s. It also creates a distinction for new T1s and many T2s. Guys like Gary Scheiner have made a living coaching new T1s - integrateddiabetes.com/meet-our-staff/I think the T2s are a completely different situation. Many want the coaching but they have no idea what to do. They see the GP for 15 minutes, given a script for metformin and told to start losing some weight and take a walk. As time goes on they get worse. Their family is constantly bugging them and they do their best to ignore them. If you go to educational clinics for T2s you would think it is almost entirely a female disease as these sessions will usually be 80% female. The properly funded and marketed T2 coaching service which can stop progression has some potential. Actually most of Gary Scheiner's customers are experienced Type 1s precisely because IDS is very good, but not cheap. I know people who have used their services in the past. The reality is that getting people to pay for diabetes coaching requires motivation and largely that is lacking. Insurers notoriously underpay for endocrinology support staff and most endo departments run at a loss if they try to include clinics. VDEX works because the people coming to them are motivated enough to seek them out and they are prepared to pay if necessary. For the rest of the T2 population there is no visible penalty for non-compliance, and consequently compliance rates are awful. People will go to a couple of classes, be told to exercise, eat better, and improve their diet, and then move on. Actual coaching takes real money and the funding source for that is simply not there unless people pay themselves. |
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Post by peppy on May 20, 2022 14:19:30 GMT -5
Aged - I think you bring up a good point. You say coaching is a non-starter. This is probably true as Bill from VDex called them in another thread "the let’s say “smarter” as a shorthand, is less likely to believe the highly improbably story that his/her care is exactly the opposite of what it should be". I would say that is true for a lot of endos and experienced T1s. It also creates a distinction for new T1s and many T2s. Guys like Gary Scheiner have made a living coaching new T1s - integrateddiabetes.com/meet-our-staff/I think the T2s are a completely different situation. Many want the coaching but they have no idea what to do. They see the GP for 15 minutes, given a script for metformin and told to start losing some weight and take a walk. As time goes on they get worse. Their family is constantly bugging them and they do their best to ignore them. If you go to educational clinics for T2s you would think it is almost entirely a female disease as these sessions will usually be 80% female. The properly funded and marketed T2 coaching service which can stop progression has some potential. Actually most of Gary Scheiner's customers are experienced Type 1s precisely because IDS is very good, but not cheap. I know people who have used their services in the past. The reality is that getting people to pay for diabetes coaching requires motivation and largely that is lacking. Insurers notoriously underpay for endocrinology support staff and most endo departments run at a loss if they try to include clinics. VDEX works because the people coming to them are motivated enough to seek them out and they are prepared to pay if necessary. For the rest of the T2 population there is no visible penalty for non-compliance, and consequently compliance rates are awful. People will go to a couple of classes, be told to exercise, eat better, and improve their diet, and then move on. Actual coaching takes real money and the funding source for that is simply not there unless people pay themselves. Also, there are times, to do the job, tools are required, or the correct tools are required. My theory. If people had a noninvasive glucose monitor, wearable, a certain amount of the population may start watching what happens when they eat and what they eat when it happens. If blood glucose levels could be brought into consciousness, some people. A wearable non-invasive glucose monitor is the next huge innovation and money maker. It boggles my mind, how the percentage of hemoglobin carrying oxygen can be determined with a non invasive source and a blood glucose level is so evasive. they both change. |
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