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Post by mnholdem on Mar 13, 2017 15:03:12 GMT -5
CMO Dr. Urbanski is the officer who is accountable for the label, not Mike Castagna.
Mike's job is to market Afrezza and to convince patient and Doctor alike how an insulin that is labeled "non-inferior" is a better choice than the other insulin treatments that are available.
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Post by mango on Mar 13, 2017 15:35:22 GMT -5
CMO Dr. Urbanski is the officer who is accountable for the label, not Mike Castagna. Mike's job is to market Afrezza and to convince patient and Doctor alike how an insulin that is labeled "non-inferior" is a better choice than the other insulin treatments that are available. Doctor: "How is Afrezza a better choice than the other insulin treatments that are available?" Answer: "Do you inform your patients that the injectable insulins you have prescribed them are amyloidogenic?"
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Post by dreamboatcruise on Mar 13, 2017 16:13:18 GMT -5
CMO Dr. Urbanski is the officer who is accountable for the label, not Mike Castagna. Mike's job is to market Afrezza and to convince patient and Doctor alike how an insulin that is labeled "non-inferior" is a better choice than the other insulin treatments that are available. Doctor: "How is Afrezza a better choice than the other insulin treatments that are available?" Answer: "Do you inform your patients that the injectable insulins you have prescribed them are amyloidogenic?" Perhaps it progresses as follows: Doctor: "No, I wouldn't raise that as an issue initially as that is fairly rare in clinical appearance. In fact the incidence is rare enough that it did not show up in initial clinical trials. We still don't have enough data on Afrezza to know whether it might have its own rare occurrences of amyloid formations. I don't think that would affect my clinical choice of prandial insulins. Are there any other benefits to Afrezza?"
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Post by lojothehus on Mar 13, 2017 16:22:30 GMT -5
Doctor: "How is Afrezza a better choice than the other insulin treatments that are available?" Answer: "Do you inform your patients that the injectable insulins you have prescribed them are amyloidogenic?" Perhaps it progresses as follows: Doctor: "No, I wouldn't raise that as an issue initially as that is fairly rare in clinical appearance. In fact the incidence is rare enough that it did not show up in initial clinical trials. We still don't have enough data on Afrezza to know whether it might have its own rare occurrences of amyloid formations. I don't think that would affect my clinical choice of prandial insulins. Are there any other benefits to Afrezza?" "Yes, there are a ton of other benefits to Afrezza. I'll tell you what doctor, people can put down the needles and can inhale Afrezza at the dinner table, at a baseball game, on the bench, and while driving in their cars. Also, from the data that we have collected thus far, the patient's A1C's are coming down very close to normal ranges. Doctor, what time do you see your next patient because we can be here until tomorrow talking about the benefits of Afrezza."
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Post by agedhippie on Mar 13, 2017 17:06:42 GMT -5
In full agreement with seanismorris and rockstarrick that the present label indication of timing (when to take Afrezza) is a huge problem and needs to change immediately. Its been a huge problem for a long time. The problems with titration and dosing and in turn retention, which MNKD has stated are significant impediments to success can be linked back to this if the patients are taking it too soon. The result will be ..its not working well and we all know how that has panned out. As I said in previous posts this is the sort of thing that MNKD should have been on top of from the beginning in seeking a change to the instructions for usage. They have spent too much of their effort banging their heads against the wall trying to "educate" the doctors with no marketing and no patient awareness as well. Absolutely should've been addressed in 2015 during the initial launch, (at the latest). My friend, T2, started afrezza and was taking it 20 minutes before eating because of the label, I told him he needs to take when he starts eating, and then may need a follow up depending on how fast he eats or what he eats. He couldn't get it into his head that he may need a follow up dose, wouldn't do it and wound up stopping afrezza because of an incorrect label. This is something that will take a lot of time, getting a PWD to stack insulin doses will not be easy. Mike has a lot of work to do, there are a lot of rough edges that need attention ASAP. Just to say - the label says take Afrezza at the start of the meal, not 20 minutes before the meal. Was he used to a different insulin and just carried on with that timing? That second dose is going to be a problem, people are not going to want to do it.
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Post by agedhippie on Mar 13, 2017 17:11:54 GMT -5
Perhaps it progresses as follows: Doctor: "No, I wouldn't raise that as an issue initially as that is fairly rare in clinical appearance. In fact the incidence is rare enough that it did not show up in initial clinical trials. We still don't have enough data on Afrezza to know whether it might have its own rare occurrences of amyloid formations. I don't think that would affect my clinical choice of prandial insulins. Are there any other benefits to Afrezza?" "Yes, there are a ton of other benefits to Afrezza. I'll tell you what doctor, people can put down the needles and can inhale Afrezza at the dinner table, at a baseball game, on the bench, and while driving in their cars. Also, from the data that we have collected thus far, the patient's A1C's are coming down very close to normal ranges. Doctor, what time do you see your next patient because we can be here until tomorrow talking about the benefits of Afrezza." Doctor: "That sounds interesting, which trial did the reduction in patients A1c come from? Oh it's anecdotal, so there is no evidence then." You can get amazing results from injected insulin as well if you put in the work, just as you can with inhaled insulin. Doctors know that, they also know that most patients will not put in the work so they are interested in how the average Joe will do. For that you need a superiority trial - can they please just get on and do that?
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Post by derek2 on Mar 13, 2017 17:19:11 GMT -5
That second dose is likely key to both the cost and efficacy issues that Mike C. references.
1. Don't take the second dose (no CGM, perhaps) and you don't keep BG low enough. 2. Take that second dose and you increase usage/cost, possibly to an unacceptable level (unacceptable to the user or to their insurance)
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Post by steve on Mar 13, 2017 17:34:09 GMT -5
That second dose is likely key to both the cost and efficacy issues that Mike C. references. 1. Don't take the second dose (no CGM, perhaps) and you don't keep BG low enough. 2. Take that second dose and you increase usage/cost, possibly to an unacceptable level (unacceptable to the user or to their insurance) But having your feet amputated and your eyes lasered is a good cost savings with shots.
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Post by mnkdnut on Mar 13, 2017 17:40:01 GMT -5
That second dose is likely key to both the cost and efficacy issues that Mike C. references. 1. Don't take the second dose (no CGM, perhaps) and you don't keep BG low enough. 2. Take that second dose and you increase usage/cost, possibly to an unacceptable level (unacceptable to the user or to their insurance) That 2nd dose, as well as getting the timing right, is also likely the keys to demonstrating superiority. CGMs are a huge advantage in learning how to do both, so the Time In Range Study is their very best shot and demonstrating superiority in some publishable form. Pediatric Study protocol will likely not require CGMs (just my guess, to allow for a wider indication) so TIR study will be evidence to convince FDA to allow for correct dose timing and follow-on dosing. I'd say, get the titration process finely tuned asap, and address the cost implications of that 2nd dose later (subscription model?).
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Post by mango on Mar 13, 2017 17:55:13 GMT -5
Doctor: "How is Afrezza a better choice than the other insulin treatments that are available?" Answer: "Do you inform your patients that the injectable insulins you have prescribed them are amyloidogenic?" Perhaps it progresses as follows: Doctor: "No, I wouldn't raise that as an issue initially as that is fairly rare in clinical appearance. In fact the incidence is rare enough that it did not show up in initial clinical trials. We still don't have enough data on Afrezza to know whether it might have its own rare occurrences of amyloid formations. I don't think that would affect my clinical choice of prandial insulins. Are there any other benefits to Afrezza?" And I would counter that false statement with: Unfortunately, doc, you are wrong, we already have a long-term study. And, BTW, localized insulin-derived amyloidosis at the site of injection is commonly misdiagnosed as lipohypertrophy— LONG-TERM PULMONARY SAFETY ASSESSMENT OF AFREZZA IN RATS AND DOGS. Based on evaluation of H&E stained tissues, there was no evidence of amyloid deposition in any portion of the respiratory tract in either species. Inhalation of AfrezzaTM up to 104 wks in rats and 39-wks in dogs did not increase PCNA labeling in alveoli, large bronchiolar or terminal bronchiolar tissues. www.toxicology.org/pubs/docs/Tox/2011Tox.pdf
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Post by derek2 on Mar 13, 2017 18:08:57 GMT -5
That second dose is likely key to both the cost and efficacy issues that Mike C. references. 1. Don't take the second dose (no CGM, perhaps) and you don't keep BG low enough. 2. Take that second dose and you increase usage/cost, possibly to an unacceptable level (unacceptable to the user or to their insurance) But having your feet amputated and your eyes lasered is a good cost savings with shots. Tell it to the people who are discontinuing, and argue it with Mike C., then scratch your head because you just can't figure out why sales aren't picking up. Also, SC insulin doesn't lead to retinopathy or amputations. Chronic high blood glucose does.
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Post by derek2 on Mar 13, 2017 18:15:26 GMT -5
That second dose is likely key to both the cost and efficacy issues that Mike C. references. 1. Don't take the second dose (no CGM, perhaps) and you don't keep BG low enough. 2. Take that second dose and you increase usage/cost, possibly to an unacceptable level (unacceptable to the user or to their insurance) That 2nd dose, as well as getting the timing right, is also likely the keys to demonstrating superiority. CGMs are a huge advantage in learning how to do both, so the Time In Range Study is their very best shot and demonstrating superiority in some publishable form. Pediatric Study protocol will likely not require CGMs (just my guess, to allow for a wider indication) so TIR study will be evidence to convince FDA to allow for correct dose timing and follow-on dosing. I'd say, get the titration process finely tuned asap, and address the cost implications of that 2nd dose later (subscription model?). I agree. Gather compelling evidence and tune treatment protocols to it. Prove the treatment protocols give an advantage and get a label change. Change the label and you can advertise the advantage.
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Post by bradleysbest on Mar 13, 2017 18:45:34 GMT -5
Januvia & Farxiga are selling.....maybe DTC does work!
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Post by dreamboatcruise on Mar 13, 2017 19:22:54 GMT -5
Perhaps it progresses as follows: Doctor: "No, I wouldn't raise that as an issue initially as that is fairly rare in clinical appearance. In fact the incidence is rare enough that it did not show up in initial clinical trials. We still don't have enough data on Afrezza to know whether it might have its own rare occurrences of amyloid formations. I don't think that would affect my clinical choice of prandial insulins. Are there any other benefits to Afrezza?" And I would counter that false statement with: Unfortunately, doc, you are wrong, we already have a long-term study. And, BTW, localized insulin-derived amyloidosis at the site of injection is commonly misdiagnosed as lipohypertrophy— LONG-TERM PULMONARY SAFETY ASSESSMENT OF AFREZZA IN RATS AND DOGS. Based on evaluation of H&E stained tissues, there was no evidence of amyloid deposition in any portion of the respiratory tract in either species. Inhalation of AfrezzaTM up to 104 wks in rats and 39-wks in dogs did not increase PCNA labeling in alveoli, large bronchiolar or terminal bronchiolar tissues. www.toxicology.org/pubs/docs/Tox/2011Tox.pdfDoctor: "I actually meant the long term post market human trials being required by the FDA."
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Post by peppy on Mar 13, 2017 19:39:28 GMT -5
Januvia & Farxiga are selling.....maybe DTC does work! Can you believe that chit is being prescribed?
Unbelievable. Killing you softly, with his song.
So Doc you are afraid afrezza might hurt me, and yet you are prescribing this chit? Am I stupid enough for you?
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