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Post by agedhippie on Mar 4, 2024 11:45:37 GMT -5
This is a brilliant statement "you cannot compete on price because if the PBM takes your insulin the pharma will jack up the price for all the other drugs the PBM needs to get from them". As far as the trial data we already have it. Afrezza will cause less hypos but thats not going to do anything as long as the PBM is jacking the price of afrezza out of the market and blockading PWDs from getting it. As you said they need to keep doing this no matter what or they screw up their "bundles". Its sounds to me Mike is between a rock and hard place if he wants to keep dealing through the PBMs and afrezza is doomed to the land of misfit niche drugs. The post-hoc analysis of the 171 trial showed that Afrezza produced less hypos, the PK/PD trial for approval showed a fast return response, what more can you ask for? Simple - does the trial data show a demonstrably better outcome. That has been the failure to date and why you need a large scale trial. Without that data nothing will change because that's what the endos care about - they are concerned with the overall outcome and not with single symptoms. Mike has no option but to continue with PBMs because they control the market. Of course he doesn't need to sell through that market, but then he is in the minor leagues with all that implies. |
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Post by cjm18 on Mar 4, 2024 11:48:59 GMT -5
This is a brilliant statement "you cannot compete on price because if the PBM takes your insulin the pharma will jack up the price for all the other drugs the PBM needs to get from them". As far as the trial data we already have it. Afrezza will cause less hypos but thats not going to do anything as long as the PBM is jacking the price of afrezza out of the market and blockading PWDs from getting it. As you said they need to keep doing this no matter what or they screw up their "bundles". Its sounds to me Mike is between a rock and hard place if he wants to keep dealing through the PBMs and afrezza is doomed to the land of misfit niche drugs. The post-hoc analysis of the 171 trial showed that Afrezza produced less hypos, the PK/PD trial for approval showed a fast return response, what more can you ask for? Simple - does the trial data show a demonstrably better outcome. That has been the failure to date and why you need a large scale trial. Without that data nothing will change because that's what the endos care about - they are concerned with the overall outcome and not with single symptoms. Mike has no option but to continue with PBMs because they control the market. Of course he doesn't need to sell through that market, but then he is in the minor leagues with all that implies. Favorable overall outcome is … superior a1c? |
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Post by prcgorman2 on Mar 4, 2024 12:54:46 GMT -5
The post-hoc analysis of the 171 trial showed that Afrezza produced less hypos, the PK/PD trial for approval showed a fast return response, what more can you ask for? Simple - does the trial data show a demonstrably better outcome. That has been the failure to date and why you need a large scale trial. Without that data nothing will change because that's what the endos care about - they are concerned with the overall outcome and not with single symptoms. Mike has no option but to continue with PBMs because they control the market. Of course he doesn't need to sell through that market, but then he is in the minor leagues with all that implies. Favorable overall outcome is … superior a1c? There seems to be affection for superior a1c AND improved Time In Range (TIR). The affection for TIR is being able to better know impact from excursions although I think there ought to be a further qualification, and it may exist and I'm just ignorant, the ratio of excursions high versus low. FWIW, I assume excursions on the high-side (e.g., above 170) are the dominant pattern, but for treating any given person with diabetes, the ratio (and specifics) would be even better. Kind of rambling, but my experience has me obsess about performance metrics.  |
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Post by sayhey24 on Mar 4, 2024 13:00:57 GMT -5
The post-hoc analysis of the 171 trial showed that Afrezza produced less hypos, the PK/PD trial for approval showed a fast return response, what more can you ask for? Simple - does the trial data show a demonstrably better outcome. That has been the failure to date and why you need a large scale trial. Without that data nothing will change because that's what the endos care about - they are concerned with the overall outcome and not with single symptoms. Mike has no option but to continue with PBMs because they control the market. Of course he doesn't need to sell through that market, but then he is in the minor leagues with all that implies. Favorable overall outcome is … superior a1c? In this case the discussion was around hypos and the fact that in the SoC it already says to reduce hypos use inhaled insulin. Which by the way is wrong. Exubera is still an approved inhaled insulin but it will not reduce hypos. Lets hope the kids study and/or Inhale 3 shows superior A1c. The 171 did in those groups which second dosed. Now this is another brilliant statement "Of course he doesn't need to sell through that market, but then he is in the minor leagues with all that implies". We are selling a little over 1k scripts a week. In my book thats the little league. I don't know what the implications are so please tell us. Maybe being in the minor leagues would be a major step forward. |
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Post by sayhey24 on Mar 4, 2024 13:14:52 GMT -5
Favorable overall outcome is … superior a1c? There seems to be affection for superior a1c AND improved Time In Range (TIR). The affection for TIR is being able to better know impact from excursions although I think there ought to be a further qualification, and it may exist and I'm just ignorant, the ratio of excursions high versus low. FWIW, I assume excursions on the high-side (e.g., above 170) are the dominant pattern, but for treating any given person with diabetes, the ratio (and specifics) would be even better. Kind of rambling, but my experience has me obsess about performance metrics. It not an affection. Its a standard based on the best tool they had at the time. TIR is an outgrowth of CGMs and everyone looking at the CGM numbers saying wow - A1c is not a very good standard. 170 is not a good number to use as a metric but its a feel good number with the RAA as getting a near normal range with them would lead to more hypos which is worse. Going over 140 is an issue. Staying over 140 for as little as 2 hours causes vascular degeneration. If you want the proper range for your metrics it would be 70 - 140. Thats the non-diabetic range and it seems using the non-diabetic range would make sense but the problem is only afrezza or a non-diabetic will hit those numbers. The RAA would not only lose to afrezza but they would lose big time. |
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Post by agedhippie on Mar 4, 2024 19:14:30 GMT -5
Favorable overall outcome is … superior a1c? There seems to be affection for superior a1c AND improved Time In Range (TIR). The affection for TIR is being able to better know impact from excursions although I think there ought to be a further qualification, and it may exist and I'm just ignorant, the ratio of excursions high versus low. FWIW, I assume excursions on the high-side (e.g., above 170) are the dominant pattern, but for treating any given person with diabetes, the ratio (and specifics) would be even better. Kind of rambling, but my experience has me obsess about performance metrics. The HbA1c result is still taken as the primary result because there is a few decades of data mapping HbA1c levels to complications. This means you can say with a reasonable degree of certainty what will happen on what timescale for a given HbA1c. The issue with HbA1c results is that there things that can lead to inaccuracy, but for the majority it works. This is why HbA1c is primary. The better approach is HbA1c and GMI. This is where the CGM result is averaged to calculate what the HbA1c result should be the HbA1c is a proxy for the average of the last three months. The benefit is that if eliminates the variables that can cause problems with an HbA1c, plus you only need two weeks of numbers. The problem is that it's not clear how accurately it mirrors your HbA1c (my GMI is a lot lower) and as such it may not map to the outcomes properly. The jury is still out but it's gaining traction. TIR is really just a breakdown of the GMI showing the percentage of time in various bands. And in answer to the earlier question I break high far more often than you break low, but with a low carb diet that may not be true (I do not eat low carb). The catch with all of this, and why outcomes are important, is that you do not need a non-diabetic HbA1c. At around 6.5% the rate of complications more or less goes flat. It means that there is little real value in getting below that (not saying that people shouldn't try if they want to.) The absolute difference in the rate of complications between 6.5 and non-diabetic is negligible. This is why doctors settle for sub 7.0 and don't push non-diabetic numbers- you are well into diminishing returns (personally I think 6.5 is a better target as 7.0 is still has a small but noticeably elevated risk) ... more than you ever wanted to know about metrics and T1 diabetes  |
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Post by peppy on Mar 4, 2024 19:34:54 GMT -5
There seems to be affection for superior a1c AND improved Time In Range (TIR). The affection for TIR is being able to better know impact from excursions although I think there ought to be a further qualification, and it may exist and I'm just ignorant, the ratio of excursions high versus low. FWIW, I assume excursions on the high-side (e.g., above 170) are the dominant pattern, but for treating any given person with diabetes, the ratio (and specifics) would be even better. Kind of rambling, but my experience has me obsess about performance metrics. The HbA1c result is still taken as the primary result because there is a few decades of data mapping HbA1c levels to complications. This means you can say with a reasonable degree of certainty what will happen on what timescale for a given HbA1c. The issue with HbA1c results is that there things that can lead to inaccuracy, but for the majority it works. This is why HbA1c is primary. The better approach is HbA1c and GMI. This is where the CGM result is averaged to calculate what the HbA1c result should be the HbA1c is a proxy for the average of the last three months. The benefit is that if eliminates the variables that can cause problems with an HbA1c, plus you only need two weeks of numbers. The problem is that it's not clear how accurately it mirrors your HbA1c (my GMI is a lot lower) and as such it may not map to the outcomes properly. The jury is still out but it's gaining traction. TIR is really just a breakdown of the GMI showing the percentage of time in various bands. And in answer to the earlier question I break high far more often than you break low, but with a low carb diet that may not be true (I do not eat low carb). The catch with all of this, and why outcomes are important, is that you do not need a non-diabetic HbA1c. At around 6.5% the rate of complications more or less goes flat. It means that there is little real value in getting below that (not saying that people shouldn't try if they want to.) The absolute difference in the rate of complications between 6.5 and non-diabetic is negligible. This is why doctors settle for sub 7.0 and don't push non-diabetic numbers- you are well into diminishing returns (personally I think 6.5 is a better target as 7.0 is still has a small but noticeably elevated risk) ... more than you ever wanted to know about metrics and T1 diabetes Look at the differences in care we are talking about. Time in range. To me it saids, we are watching blood glucose closely. Afrezza makes time in range doable, because it peak action is 30 mins after inhale and out in 90 mins. Second dose may be required after 1 hour if above 120gm/dl. at what medicine has gotten it down to. "The better approach is HbA1c and GMI. This is where the CGM result is averaged to calculate what the HbA1c result should be the HbA1c is a proxy for the average of the last three months." then the studies to back up, it will not make a bit of difference....this is good. What a bunch of hogwash. Physicians offices, I see them using that spray disinfectant and not washing their hands. Some bacterial study was done I am sure saying less bacteria with the disinfectant. The disinfectant has Phthalates. Many nurses are in their child bearing years.... . . |
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Post by prcgorman2 on Mar 4, 2024 19:35:51 GMT -5
There seems to be affection for superior a1c AND improved Time In Range (TIR). The affection for TIR is being able to better know impact from excursions although I think there ought to be a further qualification, and it may exist and I'm just ignorant, the ratio of excursions high versus low. FWIW, I assume excursions on the high-side (e.g., above 170) are the dominant pattern, but for treating any given person with diabetes, the ratio (and specifics) would be even better. Kind of rambling, but my experience has me obsess about performance metrics. The HbA1c result is still taken as the primary result because there is a few decades of data mapping HbA1c levels to complications. This means you can say with a reasonable degree of certainty what will happen on what timescale for a given HbA1c. The issue with HbA1c results is that there things that can lead to inaccuracy, but for the majority it works. This is why HbA1c is primary. The better approach is HbA1c and GMI. This is where the CGM result is averaged to calculate what the HbA1c result should be the HbA1c is a proxy for the average of the last three months. The benefit is that if eliminates the variables that can cause problems with an HbA1c, plus you only need two weeks of numbers. The problem is that it's not clear how accurately it mirrors your HbA1c (my GMI is a lot lower) and as such it may not map to the outcomes properly. The jury is still out but it's gaining traction. TIR is really just a breakdown of the GMI showing the percentage of time in various bands. And in answer to the earlier question I break high far more often than you break low, but with a low carb diet that may not be true (I do not eat low carb). The catch with all of this, and why outcomes are important, is that you do not need a non-diabetic HbA1c. At around 6.5% the rate of complications more or less goes flat. It means that there is little real value in getting below that (not saying that people shouldn't try if they want to.) The absolute difference in the rate of complications between 6.5 and non-diabetic is negligible. This is why doctors settle for sub 7.0 and don't push non-diabetic numbers- you are well into diminishing returns (personally I think 6.5 is a better target as 7.0 is still has a small but noticeably elevated risk) ... more than you ever wanted to know about metrics and T1 diabetes It's EXACTLY the kind of stuff I want to know about metrics. I like learning about T1 diabetes too. I've had T1 friends and my wife has T1 relatives. I try no to talk to them about diabetes very much because its such a personal thing I'm nervous to say anything stupid. Here I'm not worried so much because on the Internet nobody knows you're a dog. |
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Post by sayhey24 on Mar 5, 2024 7:07:41 GMT -5
The only metric you need is the AGP from the CGM with the food profile/diary. Until Al Mann invented the CGM we had no idea what was going on. Its was like driving a car without a speedometer. Now we know. Diabetes is more of an engineering problem. How many doctors prescribe the newly diagnosed T2 with a CGM? The answer is near zero. The A1c is like you average miles per hour when you are driving on a long trip. Its interesting but not much help when you are doing 64 through the 45 zone and the local sheriff pulls you over.
Back when Richard Bernstein was trying to figure things out he would ask each of the sales reps who came to see him if he could test their blood. From that he determined the 30ish male non-diabetic had a fasting BG of 87. Thats was his number. No one knew. Everyone one is a little different but it seems 140 is the magic number for vascular degeneration.
Your T1 relatives are usually doing what their doctor told them. CGMs and things like afrezza are still very new to medical schools. Ask them if you can see their 2 week AGP. Gary Scheiner has a pretty good book mostly for T1s called "Think like a pancreases". I can't remember if Gary mentions afrezza in the book but Gary too is an afrezza user.
I have not looked in a long time but VDex use to have some really interesting white papers on their website. IMO those are worth reading as they relate to afrezza.
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Post by peppy on Mar 5, 2024 8:20:36 GMT -5
The only metric you need is the AGP from the CGM with the food profile/diary. Until Al Mann invented the CGM we had no idea what was going on. Its was like driving a car without a speedometer. Now we know. Diabetes is more of an engineering problem. How many doctors prescribe the newly diagnosed T2 with a CGM? The answer is near zero. The A1c is like you average miles per hour when you are driving on a long trip. Its interesting but not much help when you are doing 64 through the 45 zone and the local sheriff pulls you over. Back when Richard Bernstein was trying to figure things out he would ask each of the sales reps who came to see him if he could test their blood. From that he determined the 30ish male non-diabetic had a fasting BG of 87. Thats was his number. No one knew. Everyone one is a little different but it seems 140 is the magic number for vascular degeneration. Your T1 relatives are usually doing what their doctor told them. CGMs and things like afrezza are still very new to medical schools. Ask them if you can see their 2 week AGP. Gary Scheiner has a pretty good book mostly for T1s called "Think like a pancreases". I can't remember if Gary mentions afrezza in the book but Gary too is an afrezza user. I have not looked in a long time but VDex use to have some really interesting white papers on their website. IMO those are worth reading as they relate to afrezza. dosing: www.seventhform.com/vdexdownloads/vdex-whitepaper-072817.pdfpage 22. Comments Afrezza’s speed of action is both a blessing and a curse. Clearly, it is a large factor in the safety of the product, but for longer meals, you may need more Afrezza to keep the post prandial levels in check. We recommend follow-on doses. For example, we advise with a standard meal to dose Afrezza 15-20 minutes after the start of the meal, and then another dose of the same size about 45 minutes later. With very long meals, we have even advised patients to administer two follow-on doses, for very tight control. |
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Post by agedhippie on Mar 5, 2024 8:44:46 GMT -5
The only metric you need is the AGP from the CGM with the food profile/diary.... The GMI is on the AGP report, as are the TIR bands. Nobody I know does a food diary - life is short! |
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Post by uvula on Mar 5, 2024 9:46:45 GMT -5
Minor correction. Al Mann did not invent the cgm.
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Post by porkini on Mar 5, 2024 11:09:29 GMT -5
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Post by uvula on Mar 5, 2024 11:20:40 GMT -5
The first CGMs came out around 1999.
Minimed was somehow involved in CGMs. Medtronic bought Minimed in 2001. Because of the time frame, it is extremely likely that Dr. Mann was involved in the early development of CGMs even if he didn't technically invent them. Before today I thought Minimed just did pumps so I learned something. Sorry to derail the thread. Back to the full year results...
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Post by akemp3000 on Mar 5, 2024 11:23:52 GMT -5
It appears the origin of the cgm evolved from Al Mann's recognition that time-in-range was much more important than A1c. What a legend.
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