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Post by comnkd on Apr 5, 2017 9:08:47 GMT -5
Just 3 years!! Watched the videos again. I have a hard time understanding how this drug can keep on failing to get enough attention. Sanofi sabotaged Afrezza, insulin cartel, shorts, etc, etc.. I used to believe earlier. But, it's too far fecthed, I guess. * Patients dont know about Afrezza. * Dosing seems to be a rocket science (10 min into meal, at 70-90 BGL, so on and on). I'm not taking a pot shot at some of the people here. It's just that there are several opinions, and MNKD doesn't seem to suggest the "Best practice". I'm not a Dr. May be if the instructions are simpler to follow, Drs will prescribe it, and patients will follow it? Since the hypo events are almost negligible with Afrezza, why not suggest 12 units for all as the starting dose, and then tune it down? * Insurance and availability. Mike is a great guy (even Matt), and he can individually deal with every single new patient every week - looking at the NRx numbers. So, what exactly is going on with sales force? Why is it failing so miserably? If you look at some of the posts here, they are advertising/selling/promoting Afrezza better than MNKD. It's already April. How much money is left now? They didn't even dilute and raise some money with RS. Now, it's just ~40 cents above $1. Come on MNKD!! You know I am frustrated that afrezza isn't selling. I now pin it down to insurance coverage, a change in insulin, and whatever it is with the endo's/is it the standard of care? afrezza works totally different than subq rapid acting. subq rapid acting let's glucose go way up and brings it down. Afrezza stops blood glucose from going up in the first place. (You can see I am still trying to work this through) Physicians at some level seem to be tied to the standards of care, because the standards of care in what insurance covers. Then as aged points out, afrezza is non-inferior, so insurance will choose the cheaper non inferior.
As Mango pointed out on another thread, the diabetic standards of care are written by people that have worked in the industry. at lilly, novo, etc.
If physicians are so smart, as we all have been sold, physicians can figure out afrezza. MNKD stock has allowed me to learn, "The racket"
peppy - Nice job placing a wrapper around the conundrum. Seems BPs fingerprints are on all the bodies...
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Post by sweedee79 on Apr 5, 2017 9:09:38 GMT -5
Zuegirdor wrote ... "This flexibility and physiological adeptness, which injected lacks, is what also makes Endos nervous. There is too much explaining to patients, which takes time when you have 100-200 of them to treat-most of which are out of target and thus all these conversations are fraught with angst of failed therapies and low self esteem on the part of patients." Zuegirdor, you are so correct to point out that Afrezza is a time management nightmare for Endos, despite all it's benefits. Clearly, Endos won't devote the time necessary to re-train "existing" patients, especially those patients with low self esteem and already stressed in patient-doctor titration conversations. As you (and others) have so correctly emphasized, Afrezza's dosing methodology requires a dramatic shift in mindset, customization and patient empowerment; and Endos just simply don't want to re-invest additional office hours in existing patients. Time is money ... and let's face it, the emphasis will always be on growing the "new' patient base while preserving the "status quo" on office time management where possible. Why should Endos duplicate valuable office time on "existing" patients when they don't have to? And, why should Endos expose themselves to added insurance paperwork (and scrutiny) to justify extra hours to shift patients to Afrezza? Imo, MNKD needs to find a way to incentivize Endos by somehow reducing the office time required to re-dose patients to Afrezza.... Perhaps some sort of "how to" short orientation film focused on Afrezza's dosing methodology (and distinctions to injectable insulin) to reduce dosage training time with the Endos. I seem to recall years ago before having a complicated surgery that I was required to view an orientation film before I met with the surgeon. This film headed off many of my questions and concerns, and unquestionably saved an immense amount of time with the surgeon. MNKD needs to find creative ways to make the dosage regime shift to Afrezza as uncomplicated "and" time-efficient for the Endos and their patients. GLTA Longs. My dad has an RN who specializes in diabetes treatment and nutrition... she spends the time with him that the doc cant... Endos don't have to do this... I think most people have seen a delegation to nurse practitioners and RNs who specialize... at least I have.. this saves money and a docs time, and is also very effective .. If endos understood Afrezza and truly wanted to prescribe... they would be.. I believe it stems more from fear, not knowing or understanding the drug ...
Its patient demand and a true understanding of what Afrezza really is that will make the difference..
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Post by zuegirdor on Apr 5, 2017 12:40:23 GMT -5
Zuegirdor wrote ... "This flexibility and physiological adeptness, which injected lacks, is what also makes Endos nervous. There is too much explaining to patients, which takes time when you have 100-200 of them to treat-most of which are out of target and thus all these conversations are fraught with angst of failed therapies and low self esteem on the part of patients." Zuegirdor, you are so correct to point out that Afrezza is a time management nightmare for Endos, despite all it's benefits. Clearly, Endos won't devote the time necessary to re-train "existing" patients, especially those patients with low self esteem and already stressed in patient-doctor titration conversations. As you (and others) have so correctly emphasized, Afrezza's dosing methodology requires a dramatic shift in mindset, customization and patient empowerment; and Endos just simply don't want to re-invest additional office hours in existing patients. Time is money ... and let's face it, the emphasis will always be on growing the "new' patient base while preserving the "status quo" on office time management where possible. Why should Endos duplicate valuable office time on "existing" patients when they don't have to? And, why should Endos expose themselves to added insurance paperwork (and scrutiny) to justify extra hours to shift patients to Afrezza? Imo, MNKD needs to find a way to incentivize Endos by somehow reducing the office time required to re-dose patients to Afrezza.... Perhaps some sort of "how to" short orientation film focused on Afrezza's dosing methodology (and distinctions to injectable insulin) to reduce dosage training time with the Endos. I seem to recall years ago before having a complicated surgery that I was required to view an orientation film before I met with the surgeon. This film headed off many of my questions and concerns, and unquestionably saved an immense amount of time with the surgeon. MNKD needs to find creative ways to make the dosage regime shift to Afrezza as uncomplicated "and" time-efficient for the Endos and their patients. GLTA Longs. I doubt MNKD would want to endorse this whole heatedly since they know Afrezza is all around the best insulin; but, what about getting the foot in the door by doing specific limited use outreach to ENDOS on the broadest scale? For example what if Afrezza's obvious superiority for corrections led the charge? You could easily instruct users trying to correct 3 hours after a meal to take a 4u Afrezza if at 140-170 (and lower with practice down to 120) and an 8u Afrezza correction from 170+ to 230 and 12U if over 230. Have them also watch BG levels to follow up as needed. This could get people used to how Afrezza works. After comfortable with the correction regimen patients could move on to prandial dosing using simple countdown rule eg at beginning of meal or 10 minutes after eating, whatever works best for them. At first they also will be learning about dose size per large vs small carb meals and how to follow meals up as needed. The last stage is learning how to stay in range BEFORE EATING. Then they learn to wait until first sign of Blood Glucose rise to take first puff-ideally before they go over 100 (we notice that somewhere between 100 and 140 there seems to be a liver dump reaction if the liver does not detect enough insulin reaching it after a meal-result being it takes more Afrezza). Once you figure out that on Afrezza "time in range" really means time in Normoglycemic state, the light comes on (at least it did for my son) and you have it dialed in. Everyone can do this, but the paradigm change is pretty significant if you have been taught not to worry about Normoglycemic range since it is simply not attainable (with any reasonable margin of safety) on injected unless you eat pretty low carb.
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Post by zuegirdor on Apr 5, 2017 12:54:08 GMT -5
I did not want to bury the lead in my previous post so...
Yesterday was son's first A1c since he tested a 7.0 at his first VDEX visit.
He tested 6.2 at his pediatric endo. He has not tested that low since his honeymoon! Drop of 0.8 is good but we are still figuring Afrezza out, still mixing with RAA to stretch out supply. From recent experience with starting meals lower and waiting longer to dose that he know he can do even better. But we'll take it.
Funny thing is, the endo team kind of freaked out. That is too low! They were concerned about Hypos even though the lowest ones they downloaded from his glucometer were only in low 60s. They were flummoxed because those lows were in middle of the night from the night time Lantus dose being too high-not prandial or daytime readings.
I felt bad not telling them the great number was from Afrezza. But we are mixing insulins and were not sure it was the right time. He will have three more A1cs with current pediatric team (and at least a few with VDEX until we can get insurance to cover). Once we go sub 6s we will spill the beans and start building the case for Kaiser to cover us.
Final note: The Dr for the first time mentioned she was going to be participating in discussions with a group of physicians (not connected to our HMO) investigating AFREZZA efficacy in pediatrics. Not sure how they are doing this. Other pedi trials planned? I think she is softening up on the idea. Fingers crossed.
By the way, I recently spent the evening talking to a physician friend who is a director of medicine at a local clinic. She is very impressed with what I told her about Afrezza's benefits for our family, less so with sales reps. Her big concern is the low compliance and target rates and the psychological complications that manifest as medical statistics. Her clinic has other issues such as insurance limitations for the lower income clientele they serve.
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Post by peppy on Apr 5, 2017 14:27:41 GMT -5
I did not want to bury the lead in my previous post so... Yesterday was son's first A1c since he tested a 7.0 at his first VDEX visit. He tested 6.2 at his pediatric endo. He has not tested that low since his honeymoon! Drop of 0.8 is good but we are still figuring Afrezza out, still mixing with RAA to stretch out supply. From recent experience with starting meals lower and waiting longer to dose that he know he can do even better. But we'll take it. Funny thing is, the endo team kind of freaked out. That is too low! They were concerned about Hypos even though the lowest ones they downloaded from his glucometer were only in low 60s. They were flummoxed because those lows were in middle of the night from the night time Lantus dose being too high-not prandial or daytime readings. I felt bad not telling them the great number was from Afrezza. But we are mixing insulins and were not sure it was the right time. He will have three more A1cs with current pediatric team (and at least a few with VDEX until we can get insurance to cover). Once we go sub 6s we will spill the beans and start building the case for Kaiser to cover us. Final note: The Dr for the first time mentioned she was going to be participating in discussions with a group of physicians (not connected to our HMO) investigating AFREZZA efficacy in pediatrics. Not sure how they are doing this. Other pedi trials planned? I think she is softening up on the idea. Fingers crossed. By the way, I recently spent the evening talking to a physician friend who is a director of medicine at a local clinic. She is very impressed with what I told her about Afrezza's benefits for our family, less so with sales reps. Her big concern is the low compliance and target rates and the psychological complications that manifest as medical statistics. Her clinic has other issues such as insurance limitations for the lower income clientele they serve. they know something is up? HgA1c to low 6.2? how is your son alive? the basal too high? you might be telling them the next visit. Fingers crossed.
Afrezza, keeps blood glucose from going high in the first place, becoming my new favorite tag line.
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Post by LosingMyBullishness on Apr 5, 2017 15:05:02 GMT -5
Right before the TASE fiasco my friend who worked for a Hedge Fund told me he heard from a contact in Israel that MNKD was doing a deal and lead them to believe even more that SNY was dropping MNKD. My friend and I had actually not been on speaking terms at times because he kept telling me to sell my shares of MNKD and I was taking it personal that my golden ticket was causing me to lose money. Right around that time my family members wife who is a nutritionist went to a conference where SNY was talking about Afrezza. So I ignored his comments and stayed the course and we all know how that went. I spoke to this nutritionist this morning because she was at conference this weekend and she told me Afrezza did come up and the two concerns the presenter (who is also a dietician) brought up are the lungs and limited dosing concerns. The limitation concerns is that there is only 4,8,12, and if a 6 was needed for example it would be hard to give that dosage. I honestly dont follow the stock as much anymore and I don't remember the dosing concerns. I would like to be able to tell her this is incorrect and if it is have Mike reach out to this dietician because a whole room full of people just wrote Afrezza off because of this dietician. There is much bullshitting around with these endoscopy. Either they are brain-dead or they are corrupt. Dosing and lung is a no-issue.
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Post by LosingMyBullishness on Apr 5, 2017 15:08:32 GMT -5
Right before the TASE fiasco my friend who worked for a Hedge Fund told me he heard from a contact in Israel that MNKD was doing a deal and lead them to believe even more that SNY was dropping MNKD. My friend and I had actually not been on speaking terms at times because he kept telling me to sell my shares of MNKD and I was taking it personal that my golden ticket was causing me to lose money. Right around that time my family members wife who is a nutritionist went to a conference where SNY was talking about Afrezza. So I ignored his comments and stayed the course and we all know how that went. I spoke to this nutritionist this morning because she was at conference this weekend and she told me Afrezza did come up and the two concerns the presenter (who is also a dietician) brought up are the lungs and limited dosing concerns. The limitation concerns is that there is only 4,8,12, and if a 6 was needed for example it would be hard to give that dosage. I honestly dont follow the stock as much anymore and I don't remember the dosing concerns. I would like to be able to tell her this is incorrect and if it is have Mike reach out to this dietician because a whole room full of people just wrote Afrezza off because of this dietician. Hope this reply comes in time to make a difference to the room you are in. the titration is an Endo bugaboo. they make their living off of being able to tell patients how much injected insulin to take. They make their living by telling people its OK to not be in range all the time becuase its better than dying of a hypo. Of course that all gets chucked out the window with Afrezza. You don't need a six or even a 2 unit cartridge unless you are a child under 10. Afrezza is cleared by the liver and bound to cell wall and other sites so rapidly that the chance of hypos is drastically reduced. the net result of this is that there is less time for "extra" insulin to work its nefarious ways. A 4 works like 1 unit or 4 units of injected depending if there is food on board. similarly an 8unit works like a 3 or an 8 unit of injected depending on hether food is in the system. that is my observation but you can easily confirm with others on afrezza. This flesibility and physiological adeptness, which injected lacks, is what also makes Endos nervous. There is too much explaining to patients, which takes time when you have 100-200 of them to treat-most of which are out of target and thus all these conversations are fraught with angst of failed therapies and low self esteem on the part of patients. But that does not escsue your "friend" for talking out his @ss about what he has no first hand knowledge of. He can reach me on Twitter if he has any questions. Handle is Afrezza4Teens An explicit thank you. So the endos are rather corrupt than stupid. Could it be that the US is not the right market due to the wrong incentives?
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Post by LosingMyBullishness on Apr 5, 2017 15:13:46 GMT -5
Afrezza is different than subq insulin. Phase one and two and all. I wish MNKD would make a deal in Israel. Mango tells me Raphael Mechoulam, has several patents now for synthetic CBD compounds. That would be one deal MNKD could take. TEVA, it would seem to me teva could take over fast acting insulin human. human insulin does not require a prescription?
OK, my last barrage was delivered at light speed in case there were time constraints at your end. I need reiterate that titration is magic cepter of endocrinology practices. It casts a spell of logic and confidence over the proceedings in the endo's office. Only that spell does not protect the patient when he returns to his home and realizes that injected does not really "titrate" either. That is what hypos and 65% of patients out of target Blood Glucose means. tell the Dietician that his patients need faster, more phyisologically adept, injected insulin if they want to go around talking about "titratability". Truth is that the only way to titrate injected insulin well is by having Diabetics eat low carb. Great idea and everything, but it begs the point about the titratability of insulins. I am furious as you can tell. So as to titrating Afrezza. something we are realizing is that Afrezza also works best if you can start meal time dosing while in the 70-90 range, just like normoglycemic individuals. Chasing a high blood sugar at meals or any other time, will mean you will need to take more Afrezza. Its hard to find the motivation for this technique because Afrezza will correct you so fast if you blow it. But after a while you understand how much more efficient it is to stay in range. I think that is why you see Eric F, Sam F Cynthia R-K, Duckfiabetes and Afrezzaguy CGM traces in flatline. We just started doing that with my son this week end and whoa what a difference. He needs half as much Afrezza-which is big for us since wwe pay OUT OF POCKET for it and have frequently been running out. Now he stays in range (generally below 100)AND uses less Afrezza! The big take home for us was that the amounts needed to titrate change with the range you have set. we have been using Afrezza for him for three months and just now realized we were still under the Endo's spell. We believed that the 130 to 80 range they set for him as a 17 year old(was 180 to 80 a year ago) was reasonable. It may be for injected but it is all wrong for dosing Afrezza. It is OK to go to 130 or higher while on afrezza after a meal, but your range pre-meal and post digestion should be the same as a normoglycemic individual: 70 to 90! ITS WHAT THE BODY WANTS. And it is making a huge difference as we learned this weekend. My son did not get enthusiastic about follow up dosing until we saw this pattern working. Titration has less to do with this kind of control than timeing and setting the normal type of Fasting Blood Glucose targets THAT ONLY AFREZZA allows you to set (assuming you like to eat a conventional diet). Nice to learn that some patients see the benefit s at last. What is with the rest of the bunch? There must be more than a handful of intelligent diabetics?
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Post by sayhey24 on Apr 5, 2017 15:27:31 GMT -5
Zuegirdor wrote ... "This flexibility and physiological adeptness, which injected lacks, is what also makes Endos nervous. There is too much explaining to patients, which takes time when you have 100-200 of them to treat-most of which are out of target and thus all these conversations are fraught with angst of failed therapies and low self esteem on the part of patients." Zuegirdor, you are so correct to point out that Afrezza is a time management nightmare for Endos, despite all it's benefits. Clearly, Endos won't devote the time necessary to re-train "existing" patients, especially those patients with low self esteem and already stressed in patient-doctor titration conversations. As you (and others) have so correctly emphasized, Afrezza's dosing methodology requires a dramatic shift in mindset, customization and patient empowerment; and Endos just simply don't want to re-invest additional office hours in existing patients. Time is money ... and let's face it, the emphasis will always be on growing the "new' patient base while preserving the "status quo" on office time management where possible. Why should Endos duplicate valuable office time on "existing" patients when they don't have to? And, why should Endos expose themselves to added insurance paperwork (and scrutiny) to justify extra hours to shift patients to Afrezza? Imo, MNKD needs to find a way to incentivize Endos by somehow reducing the office time required to re-dose patients to Afrezza.... Perhaps some sort of "how to" short orientation film focused on Afrezza's dosing methodology (and distinctions to injectable insulin) to reduce dosage training time with the Endos. I seem to recall years ago before having a complicated surgery that I was required to view an orientation film before I met with the surgeon. This film headed off many of my questions and concerns, and unquestionably saved an immense amount of time with the surgeon. MNKD needs to find creative ways to make the dosage regime shift to Afrezza as uncomplicated "and" time-efficient for the Endos and their patients. GLTA Longs. I doubt MNKD would want to endorse this whole heatedly since they know Afrezza is all around the best insulin; but, what about getting the foot in the door by doing specific limited use outreach to ENDOS on the broadest scale? For example what if Afrezza's obvious superiority for corrections led the charge? You could easily instruct users trying to correct 3 hours after a meal to take a 4u Afrezza if at 140-170 (and lower with practice down to 120) and an 8u Afrezza correction from 170+ to 230 and 12U if over 230. Have them also watch BG levels to follow up as needed. This could get people used to how Afrezza works. After comfortable with the correction regimen patients could move on to prandial dosing using simple countdown rule eg at beginning of meal or 10 minutes after eating, whatever works best for them. At first they also will be learning about dose size per large vs small carb meals and how to follow meals up as needed. The last stage is learning how to stay in range BEFORE EATING. Then they learn to wait until first sign of Blood Glucose rise to take first puff-ideally before they go over 100 (we notice that somewhere between 100 and 140 there seems to be a liver dump reaction if the liver does not detect enough insulin reaching it after a meal-result being it takes more Afrezza). Once you figure out that on Afrezza "time in range" really means time in Normoglycemic state, the light comes on (at least it did for my son) and you have it dialed in. Everyone can do this, but the paradigm change is pretty significant if you have been taught not to worry about Normoglycemic range since it is simply not attainable (with any reasonable margin of safety) on injected unless you eat pretty low carb. I think your idea about a "corrections" is 100% spot on. I proposed a similar idea to Mike at the SHM last year. The concept was to have a smaller box maybe 10 cartridges with some combination of 4 and 8's, probably more 4's than 8's. My suggestion was to call it by a different name like afrezza-ER or afrezza-MAX, whatever. Since it was only to be used for corrections the FDA should drop the spirometry requirement and there is little need for the black-box since its only for occasional use. I also suggested since afrezza is nothing more than human insulin it should not require a prescription in most states, just like the other human insulins. I would sell it very cheap lets say $20 a box, over the counter so insurance coverage is not so important. Maybe they could also make another "product" for corrections covered by insurance with a prescription which has more cartridges and costs more. Who knows maybe even Aged would pluck down the $20 and not tell his Endo who will not prescribe afrezza for him.
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Post by zuegirdor on Apr 5, 2017 17:01:30 GMT -5
I doubt MNKD would want to endorse this whole heatedly since they know Afrezza is all around the best insulin; but, what about getting the foot in the door by doing specific limited use outreach to ENDOS on the broadest scale? For example what if Afrezza's obvious superiority for corrections led the charge? You could easily instruct users trying to correct 3 hours after a meal to take a 4u Afrezza if at 140-170 (and lower with practice down to 120) and an 8u Afrezza correction from 170+ to 230 and 12U if over 230. Have them also watch BG levels to follow up as needed. This could get people used to how Afrezza works. After comfortable with the correction regimen patients could move on to prandial dosing using simple countdown rule eg at beginning of meal or 10 minutes after eating, whatever works best for them. At first they also will be learning about dose size per large vs small carb meals and how to follow meals up as needed. The last stage is learning how to stay in range BEFORE EATING. Then they learn to wait until first sign of Blood Glucose rise to take first puff-ideally before they go over 100 (we notice that somewhere between 100 and 140 there seems to be a liver dump reaction if the liver does not detect enough insulin reaching it after a meal-result being it takes more Afrezza). Once you figure out that on Afrezza "time in range" really means time in Normoglycemic state, the light comes on (at least it did for my son) and you have it dialed in. Everyone can do this, but the paradigm change is pretty significant if you have been taught not to worry about Normoglycemic range since it is simply not attainable (with any reasonable margin of safety) on injected unless you eat pretty low carb. I think your idea about a "corrections" is 100% spot on. I proposed a similar idea to Mike at the SHM last year. The concept was to have a smaller box maybe 10 cartridges with some combination of 4 and 8's, probably more 4's than 8's. My suggestion was to call it by a different name like afrezza-ER or afrezza-MAX, whatever. Since it was only to be used for corrections the FDA should drop the spirometry requirement and there is little need for the black-box since its only for occasional use. I also suggested since afrezza is nothing more than human insulin it should not require a prescription in most states, just like the other human insulins. I would sell it very cheap lets say $20 a box, over the counter so insurance coverage is not so important. Maybe they could also make another "product" for corrections covered by insurance with a prescription which has more cartridges and costs more. Who knows maybe even Aged would pluck down the $20 and not tell his Endo who will not prescribe afrezza for him. No, this IS your idea. I read about it in another post I believe. The unique name is great idea! and the price point. all inspired! What did Mike say when you offered it up free of charge?
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Post by mango on Apr 5, 2017 17:13:50 GMT -5
Hope this reply comes in time to make a difference to the room you are in. the titration is an Endo bugaboo. they make their living off of being able to tell patients how much injected insulin to take. They make their living by telling people its OK to not be in range all the time becuase its better than dying of a hypo. Of course that all gets chucked out the window with Afrezza. You don't need a six or even a 2 unit cartridge unless you are a child under 10. Afrezza is cleared by the liver and bound to cell wall and other sites so rapidly that the chance of hypos is drastically reduced. the net result of this is that there is less time for "extra" insulin to work its nefarious ways. A 4 works like 1 unit or 4 units of injected depending if there is food on board. similarly an 8unit works like a 3 or an 8 unit of injected depending on hether food is in the system. that is my observation but you can easily confirm with others on afrezza. This flesibility and physiological adeptness, which injected lacks, is what also makes Endos nervous. There is too much explaining to patients, which takes time when you have 100-200 of them to treat-most of which are out of target and thus all these conversations are fraught with angst of failed therapies and low self esteem on the part of patients. But that does not escsue your "friend" for talking out his @ss about what he has no first hand knowledge of. He can reach me on Twitter if he has any questions. Handle is Afrezza4Teens An explicit thank you. So the endos are rather corrupt than stupid. Could it be that the US is not the right market due to the wrong incentives? I don't think they are all corrupt, but I know that many are and many are influenced by the ones who are employed by one of the major three (Sanofi, Lilly and Novo). One fundamental problem could be their age. 2014 Endocrine Society
I am not knocking them because of their age, I am just suggesting that perhaps many are stuck in their ways and are more resistant to change. This can be seen across the field in many specialties. Some embrace it some resist it. The problem I see is the influence over the entire medical community of Endocrinologists. Birds of a feather flock together. The Endo community might need to be reminded of their history and who is largely responsible for all of this innovation. It is none other than our very own—the late and great Alfred Mann. Alfred Mann founded MiniMed in 1993. He served as the CEO and Chairman until the acquisition by Medtronic in 2001. It was this company, MiniMed, that revolutionized the diabetes world with the introduction of a CGM device. In the mid 90's MiniMed was the first company to conduct clinical trials with continuous glucose sensors in the United States. Before MiniMed was aquired by Medtronic it was also the first company in the United States to receive FDA approval for a CGM device (1999). Then, we have the Medical Research Group that was also founded by Alfred Mann. This company is the origins of the artificial pancreas. Medtronic also aquired Medical Research Group and were granted FDA approval last year for the world's first closed-loop system artificial pancreas. Fast forward to 2014 when the FDA approved Afrezza. We all know this is an ultra-rapid acting insulin monomer which mimics the endogenous secretion of mealtime insulin production within the body like that of a healthy pancreas. So why the resistance? I will reserve my personal opinions on that.
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Post by tingtongtung on Apr 5, 2017 18:46:47 GMT -5
Just 3 years!! Watched the videos again. I have a hard time understanding how this drug can keep on failing to get enough attention. Sanofi sabotaged Afrezza, insulin cartel, shorts, etc, etc.. I used to believe earlier. But, it's too far fecthed, I guess. * Patients dont know about Afrezza. * Dosing seems to be a rocket science (10 min into meal, at 70-90 BGL, so on and on). I'm not taking a pot shot at some of the people here. It's just that there are several opinions, and MNKD doesn't seem to suggest the "Best practice". I'm not a Dr. May be if the instructions are simpler to follow, Drs will prescribe it, and patients will follow it? Since the hypo events are almost negligible with Afrezza, why not suggest 12 units for all as the starting dose, and then tune it down? * Insurance and availability. Mike is a great guy (even Matt), and he can individually deal with every single new patient every week - looking at the NRx numbers. So, what exactly is going on with sales force? Why is it failing so miserably? If you look at some of the posts here, they are advertising/selling/promoting Afrezza better than MNKD. It's already April. How much money is left now? They didn't even dilute and raise some money with RS. Now, it's just ~40 cents above $1. Come on MNKD!! You know I am frustrated that afrezza isn't selling. I now pin it down to insurance coverage, a change in insulin, and whatever it is with the endo's/is it the standard of care? afrezza works totally different than subq rapid acting. subq rapid acting let's glucose go way up and brings it down. Afrezza stops blood glucose from going up in the first place. (You can see I am still trying to work this through) Physicians at some level seem to be tied to the standards of care, because the standards of care in what insurance covers. Then as aged points out, afrezza is non-inferior, so insurance will choose the cheaper non inferior.
As Mango pointed out on another thread, the diabetic standards of care are written by people that have worked in the industry. at lilly, novo, etc.
If physicians are so smart, as we all have been sold, physicians can figure out afrezza. MNKD stock has allowed me to learn, "The racket"
peppy, I certainly understand your views and frustrations.. I understand that Drs follow the protocol you mentioned.. It's just like my prof told me to do this when I was in school, I will do that, and will tell the new student to do the same thing. When tech changes, there is resistance to change by people. If you dont adapt, you will be left behind. But to drive the knowledge, you need capital/connections/your own clinic (in this case). I thought VDex was our solution. But, MNKD doesn't seem to care (may be there are rules?). They are still following the failed path of trying to educate Drs. If you tell a store owner to do something that benefits the customer (and not the store owner), do you think they would do it? No.. They just don't care. If there is a potential of getting sued by the customer for trying to do something good to the customer, no way in hell the store owner will try the new option. In that case, your option is bribe (incentive, whatever you call it) the owner for so long that, they will follow it. Or, you start your own store following your way. Or, you spend money educating people until they start demanding the stores to follow the new option. Did MNKD know what they were/are against from the beginning? I think so (or, at least realized during Sanofi???) If they did not, well, tough luck and they should have learned the lesson by now.. MNKD is still trying to do the same thing of trying to educate Drs. At least Mike is saying that MNKD would ship Afrezza directly to patients. If the conspiracy thing is really true (is it, or is it just that Drs are scared of lawsuits?, but insurers sure look very suspect), what's MNKD doing to get past it? TSLA took care of "must have dealership" rule, and is moving forward to beat every car maker. What has MNKD learned over the last 3 years?
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Post by sayhey24 on Apr 5, 2017 19:01:56 GMT -5
I think your idea about a "corrections" is 100% spot on. I proposed a similar idea to Mike at the SHM last year. The concept was to have a smaller box maybe 10 cartridges with some combination of 4 and 8's, probably more 4's than 8's. My suggestion was to call it by a different name like afrezza-ER or afrezza-MAX, whatever. Since it was only to be used for corrections the FDA should drop the spirometry requirement and there is little need for the black-box since its only for occasional use. I also suggested since afrezza is nothing more than human insulin it should not require a prescription in most states, just like the other human insulins. I would sell it very cheap lets say $20 a box, over the counter so insurance coverage is not so important. Maybe they could also make another "product" for corrections covered by insurance with a prescription which has more cartridges and costs more. Who knows maybe even Aged would pluck down the $20 and not tell his Endo who will not prescribe afrezza for him. No, this IS your idea. I read about it in another post I believe. The unique name is great idea! and the price point. all inspired! What did Mike say when you offered it up free of charge? Mike was pretty new to MNKD last June. I am not really sure he really understood what I was talking about. I told him the only thing which would save afrezza was technology; CGMS hooked to the cloud; teledocs and telecoaches. I told him what the Endo at the ADCOM said about afrezza crushing his practice and Endos were not his friend. I told him it was not packaged properly and pharmacy's would have an issue with refrigeration space and there was absolutely no reason it needed to be refrigerated if it was going to be used in 2 years. I told him he better think about selling direct to address this. I told him more things, probably too much because at the end I think he thought I was a nut. I turned to the lady who was with me as we were leaving and I told her I think he thinks I am crazy. She said he was listening. A year later I think he is starting to get it. Stefan Schwarz has this right. He said in May '15 he needed to take a different direction and he knows the big market is the T2s and that 90% of them are treated by PCPs. I am absolutely convinced including by my own personal experience is if you take a new T2, put them on insulin and get their FBG below 100 within 3 hours of eating most will be put into remission and some will actually see significant improvements. My eyesight was getting really bad, I have not felt better in years and I hardly even use reading glasses anymore. If they can get the FBG into the low 90's or 80's on their own with diet and exercise, great but most can't. My friends best friend is a physical therapist. By the time he was diagnosed his BG was shy of 300. His doctor wanted him to go on metformin and then he read all the bad things about it. I found out yesterday he had already read some reports of it being associated to dementia. He has been starving himself and exercising hours per day. His FBG is now around 120. I have told him its time for afrezza but he really thinks he is going to do it with no medication. I gave him my protocol and now I think he is close to giving it a try. This guy is atypical. Most can not attempt to do what he is trying to do but the bottom line is he has too much damage and his beta cells need a rest. As I have told him with afrezza there is no need to go crazy starving and going over the top with exercising. Get the pancreas back into shape and then eat and exercise in moderation. Diabetes is an engineering flow control problem. We have used realtime sensors for years for flow control. The medical world is 20+ years behind the times. afrezza needs the technology to catch up.
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Post by nylefty on Apr 5, 2017 19:41:03 GMT -5
You know I am frustrated that afrezza isn't selling. I now pin it down to insurance coverage, a change in insulin, and whatever it is with the endo's/is it the standard of care? If the conspiracy thing is really true (is it, or is it just that Drs are scared of lawsuits?, but insurers sure look very suspect), what's MNKD doing to get past it? TSLA took care of "must have dealership" rule, and is moving forward to beat every car maker. TSLA doesn't have to contend with the FDA and still hasn't "taken care" of the "must have dealership rule" in several states, including Texas, Michigan, and Connecticut. It's also losing a lot more money than MannKind, although the stock has held up much better.
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Post by sayhey24 on Apr 6, 2017 5:24:21 GMT -5
If the conspiracy thing is really true (is it, or is it just that Drs are scared of lawsuits?, but insurers sure look very suspect), what's MNKD doing to get past it? TSLA took care of "must have dealership" rule, and is moving forward to beat every car maker. TSLA doesn't have to contend with the FDA and still hasn't "taken care" of the "must have dealership rule" in several states, including Texas, Michigan, and Connecticut. It's also losing a lot more money than MannKind, although the stock has held up much better. Historically, the FDA and Big Pharma have been tied at the hip against MNKD. Maybe the "correction" product could do an end around a few things including the spirometry testing. Assuming they get FDA approval they could put 10 cartridges in a box, sell it for $20 over the counter and direct from their website and should not be required to have a prescription in most states. Clearly they would then need a DTC campaign. The bottom line is MNKD management needs to get a little creative and get things done, asap. The embarrassment of riches has just turned into the embarrassment of not getting things done fast enough.
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