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Post by xanet on Mar 2, 2018 11:39:45 GMT -5
Since we're not employed or encumbered by FDA regulations, might it make sense for this board's activists to create our own professionally created Afrezza web site that displays all the best information we've reviewed. Once we have it we could then pay the fees to ensure it's prominently displayed in Google (and Bing) search results. I'd be willing to contribute some funding and even help a bit--IT stuff not web design things... Thoughts? That's a great idea, but really requires a team dedicated to the effort. I think the simpler approach at the beginning is to put some work into creating a Wikipedia entry. 'Afrezza' redirects to 'inhalable insulin' and the article is really outdated and anemic. Positive information added about Afrezza has been removed on several occasions, probably because that information was not deemed to be adequately supported by peer-reviewed material. Someone with the time and interest could either add scientific information properly referenced to the existing article, or maybe figure out how to get an actual entry for Afrezza. I have not contributed to Wikipedia and don't have the time, so this is really beyond me, but would be a great first step and low-hanging fruit, IMO. |
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Post by dreamboatcruise on Mar 2, 2018 12:12:32 GMT -5
That was a good interview. I am curious about the very last paragraph. "I absolutely see a need to bring that language into the conversation at MannKind, in talking to healthcare providers and working with our regulatory team, advocates and others. We'd love to include patient stories and examples in product information, and in what we share with healthcare providers." Is there really any chance they can put patient stories and examples (anecdotal clinical data?) in product information? Is this a realistic goal, or is it more like saying "We'd love to have world peace and the end of poverty". DBC - the question Dr. Kendall is addressing is "Has MannKind embraced the “Beyond A1C” message for Afrezza?" The short answer is no, they have not. Mike and guys main focus has been A1c. Are they aware of it sure but its not what they have been about. We here on Proboards have been focused on “Beyond A1C” for a very long time. We have been talking about time in range, use of the CGM, Cloud Monitoring and the Libre way before it was approved. We have known afrezza is a real time solution to a real time problem which is "Stopping the Spike" after meals. Mike and team's main focus has been A1c and not TIR. What we do know is Dr. Kendall has found the treasurer chest filled with the 60+ studies. Can he combine these studies in conjunction with non-scientifc data which shows an example like the VDex whitepaper, maybe? The thing about the VDex paper is its a do it yourself instruction kit - if you don't believe their paper try it yourself. Lets see what he can come up with. Given that they funded and have completed a TIR clinical trial I'm not sure I'd agree they don't have a focus on that. Now if you said the FDA does not have a focus on that yet, I'd agree fully. Would the FDA even allow TIR data from the STAT study into the Afrezza label... dunno? My questions were really having to do with FDA restrictions. It is my understanding that anecdotal patient experiences cannot be used in product literature or marketing material. That is unless what they say is so nonspecific that it would apply to all patients... e.g. you could have a quote from a patient saying "Afrezza allowed me to control my post meal blood glucose" but not "with Afrezza my post meal blood glucose never exceeded 140". Just curious what he meant by including patient stories, as he must understand FDA restrictions. |
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Post by cretin11 on Mar 2, 2018 12:54:53 GMT -5
Since we're not employed or encumbered by FDA regulations, might it make sense for this board's activists to create our own professionally created Afrezza web site that displays all the best information we've reviewed. Once we have it we could then pay the fees to ensure it's prominently displayed in Google (and Bing) search results. I'd be willing to contribute some funding and even help a bit--IT stuff not web design things... Thoughts? That's a great idea, but really requires a team dedicated to the effort. I think the simpler approach at the beginning is to put some work into creating a Wikipedia entry. 'Afrezza' redirects to 'inhalable insulin' and the article is really outdated and anemic. Positive information added about Afrezza has been removed on several occasions, probably because that information was not deemed to be adequately supported by peer-reviewed material. Someone with the time and interest could either add scientific information properly referenced to the existing article, or maybe figure out how to get an actual entry for Afrezza. I have not contributed to Wikipedia and don't have the time, so this is really beyond me, but would be a great first step and low-hanging fruit, IMO. xanet that is a great idea, Afrezza should have a wiki page. As you said, it does seem like low hanging fruit. The current wiki for inhaled insulin is not very complimentary to MNKD, it looks like it was approved by BP... |
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Post by hellodolly on Mar 2, 2018 13:08:39 GMT -5
That was a good interview. I am curious about the very last paragraph. "I absolutely see a need to bring that language into the conversation at MannKind, in talking to healthcare providers and working with our regulatory team, advocates and others. We'd love to include patient stories and examples in product information, and in what we share with healthcare providers." Is there really any chance they can put patient stories and examples (anecdotal clinical data?) in product information? Is this a realistic goal, or is it more like saying "We'd love to have world peace and the end of poverty". Which idea is 'pie in the sky?' Better yet and another way to look at answering your question of this being a 'realistic goal', which idea has a better chance of happening between the two...patient stories and examples in product information or world peace and the end of poverty? |
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Post by dreamboatcruise on Mar 2, 2018 13:32:53 GMT -5
That was a good interview. I am curious about the very last paragraph. "I absolutely see a need to bring that language into the conversation at MannKind, in talking to healthcare providers and working with our regulatory team, advocates and others. We'd love to include patient stories and examples in product information, and in what we share with healthcare providers." Is there really any chance they can put patient stories and examples (anecdotal clinical data?) in product information? Is this a realistic goal, or is it more like saying "We'd love to have world peace and the end of poverty". Which idea is 'pie in the sky?' Better yet and another way to look at answering your question of this being a 'realistic goal', which idea has a better chance of happening between the two...patient stories and examples in product information or world peace and the end of poverty? We've actually been making progress on world poverty over the last couple of decades. |
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Post by sayhey24 on Mar 2, 2018 16:10:46 GMT -5
That's a great idea, but really requires a team dedicated to the effort. I think the simpler approach at the beginning is to put some work into creating a Wikipedia entry. 'Afrezza' redirects to 'inhalable insulin' and the article is really outdated and anemic. Positive information added about Afrezza has been removed on several occasions, probably because that information was not deemed to be adequately supported by peer-reviewed material. Someone with the time and interest could either add scientific information properly referenced to the existing article, or maybe figure out how to get an actual entry for Afrezza. I have not contributed to Wikipedia and don't have the time, so this is really beyond me, but would be a great first step and low-hanging fruit, IMO. xanet that is a great idea, Afrezza should have a wiki page. As you said, it does seem like low hanging fruit. The current wiki for inhaled insulin is not very complimentary to MNKD, it looks like it was approved by BP... I think the afrezzajustbreathe.com is very good and I often use it when I am looking for something. What I would suggest is if you think you can make it better contact Twitter account: texasreader@livenlearn2015 and give him a hand. If you want a different url what I would do is just set it up and direct it to afrezzajustbreathe.com If you can update the Wiki page please do so. Every time I have tried in the past it gets changed back in a day or so and I am registered with Wiki. Not saying there is a conspiracy but ... just saying someone is actively watching it. |
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Post by sayhey24 on Mar 2, 2018 16:49:43 GMT -5
DBC - the question Dr. Kendall is addressing is "Has MannKind embraced the “Beyond A1C” message for Afrezza?" The short answer is no, they have not. Mike and guys main focus has been A1c. Are they aware of it sure but its not what they have been about. We here on Proboards have been focused on “Beyond A1C” for a very long time. We have been talking about time in range, use of the CGM, Cloud Monitoring and the Libre way before it was approved. We have known afrezza is a real time solution to a real time problem which is "Stopping the Spike" after meals. Mike and team's main focus has been A1c and not TIR. What we do know is Dr. Kendall has found the treasurer chest filled with the 60+ studies. Can he combine these studies in conjunction with non-scientifc data which shows an example like the VDex whitepaper, maybe? The thing about the VDex paper is its a do it yourself instruction kit - if you don't believe their paper try it yourself. Lets see what he can come up with. Given that they funded and have completed a TIR clinical trial I'm not sure I'd agree they don't have a focus on that. Now if you said the FDA does not have a focus on that yet, I'd agree fully. Would the FDA even allow TIR data from the STAT study into the Afrezza label... dunno? My questions were really having to do with FDA restrictions. It is my understanding that anecdotal patient experiences cannot be used in product literature or marketing material. That is unless what they say is so nonspecific that it would apply to all patients... e.g. you could have a quote from a patient saying "Afrezza allowed me to control my post meal blood glucose" but not "with Afrezza my post meal blood glucose never exceeded 140". Just curious what he meant by including patient stories, as he must understand FDA restrictions. Mike and the sales team's main focus has been A1c. Are they aware of TIR, yes. Have they funded the clamp study and the STAT sure. However, if you talk with the sales team "in general" they are talking A1c. What Dr. Kendall said was "My dream is to have an FDA leader who personally lives with type 1 and understands what it’s like to have a blood glucose of 220 versus 110, what it feels like to have an hour’s worth of glucose values in the 50s, how it disrupts your day. All of that isn’t captured in A1C or necessarily in (regular meter monitoring)". Additionally, Dr. Kendall now has in his possession over 30 proprietary studies which show how TIR can stop and if enough beta cells are still there can promote beta cell regeneration. He does not have to rely on anecdotal patient experiences. If the sales staff can show examples in clinical use which are backed by the studies then he addresses "We'd love to include patient stories and examples in product information, and in what we share with healthcare providers." Now, how up to speed are all the sales staff? I don't know. I know they have training next week and hopefully Dr. Kendall will do some teaching. What I can say is the afrezza sales guy who met with a medical group in my area knew little and could not really explain in over two hours to the group why they should use afrezza and how it fits into the T2 protocol. Is that typical? I hope not but these guys are going into an entrenched world. TIR is not generally understood. If it was they would not be giving out the metformin or the SGLT-2s or even the basal. We are asking our sales staff to be experts not only in current practice and why it does not work but what does work and how afrezza is the cornerstone of the paradigm shift. We are asking the shoe leather sales guy to be an expert. IMO, fat chance at this point in time. Prior to Dr. Kendall showing up I am not sure that knowledge was in MNKD. I am pretty sure Ray Urbansky did not have near the knowledge level of Dr. Kendall. We know Mike did not have it, just look at the interview he did when he talked about him meeting Alan Marcus. It was clear to me when I first met Mike 2 years ago there was a knowledge gap which needed filling. The great news is Dr. Kendall is now here. |
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Post by dreamboatcruise on Mar 2, 2018 17:00:45 GMT -5
sayhey24... as if often discussed here, sales reps are limited to discuss what is in the FDA approved label and marketing materials. No one is asking them to present info to docs that goes beyond what the FDA allows... I would hope, since many pharma have gotten in big trouble for doing that in the past. I would assume at this point that the sales reps primary contribution is helping make sure clinical staff is trained on patient education and that docs are offloaded from hassle of prior auths.
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Post by porkini on Mar 2, 2018 17:26:17 GMT -5
Since we're not employed or encumbered by FDA regulations, might it make sense for this board's activists to create our own professionally created Afrezza web site that displays all the best information we've reviewed. Once we have it we could then pay the fees to ensure it's prominently displayed in Google (and Bing) search results. I'd be willing to contribute some funding and even help a bit--IT stuff not web design things... Thoughts? That's a great idea, but really requires a team dedicated to the effort. I think the simpler approach at the beginning is to put some work into creating a Wikipedia entry. 'Afrezza' redirects to 'inhalable insulin' and the article is really outdated and anemic. Positive information added about Afrezza has been removed on several occasions, probably because that information was not deemed to be adequately supported by peer-reviewed material. Someone with the time and interest could either add scientific information properly referenced to the existing article, or maybe figure out how to get an actual entry for Afrezza. I have not contributed to Wikipedia and don't have the time, so this is really beyond me, but would be a great first step and low-hanging fruit, IMO. After digging around Wikipedia for a moment or two, it seems that they redirect a lot of stuff that is branded to a "disambiguation" page. Even Tylenol or Trulicity. Comet cleanser, not so much. So, a page on Afrezza, disambiguate. A page on MannKind Corporation, reads like a press release - now here is where someone might shine to be objective and clean up a page and pick some low hanging fruit! NOTE: I did not make the rules on Wikipedia and am only reporting what I found, so please leave your attacks on why I created Wikipedia with a bias against Afrezza at home, trapped behind your fingerprints, thanks. |
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Post by sayhey24 on Mar 2, 2018 17:36:23 GMT -5
DBC - I for one am expecting them to go way beyond what's on the label. Good Grief, if thats what they are doing its no surprise we have 400 scripts a week. Next week they all need to be briefed on the 118 trial for starteres and they better have all the info highlighted here including all studies done
pharmatips.in/Articles/Pharma-Marketing/What-Doctors-Expect-From-Medical-Representative.aspx
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Post by dreamboatcruise on Mar 2, 2018 17:44:51 GMT -5
That's a great idea, but really requires a team dedicated to the effort. I think the simpler approach at the beginning is to put some work into creating a Wikipedia entry. 'Afrezza' redirects to 'inhalable insulin' and the article is really outdated and anemic. Positive information added about Afrezza has been removed on several occasions, probably because that information was not deemed to be adequately supported by peer-reviewed material. Someone with the time and interest could either add scientific information properly referenced to the existing article, or maybe figure out how to get an actual entry for Afrezza. I have not contributed to Wikipedia and don't have the time, so this is really beyond me, but would be a great first step and low-hanging fruit, IMO. After digging around Wikipedia for a moment or two, it seems that they redirect a lot of stuff that is branded to a "disambiguation" page. Even Tylenol or Trulicity. Comet cleanser, not so much. So, a page on Afrezza, disambiguate. A page on MannKind Corporation, reads like a press release - now here is where someone might shine to be objective and clean up a page and pick some low hanging fruit! NOTE: I did not make the rules on Wikipedia and am only reporting what I found, so please leave your attacks on why I created Wikipedia with a bias against Afrezza at home, trapped behind your fingerprints, thanks. It would seem that their model is to have the brand name redirect to a page titled with the generic name. Humalog redirects to Insulin Lispro and Novolog redirects to Insulin aspart. Given this, it seems someone needs to create a "(insulin human) Inhalation Powder" which is the generic designation for Afrezza, and have the Afrezza page redirect there. Though the generic designation for Exubera seems oddly similar. I'm surprised that the FDA didn't do a better job of distinguishing the two. If Exubera were still on the market they certainly aren't substitutes for one another. |
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Post by sellhighdrinklow on Mar 2, 2018 18:12:58 GMT -5
I LOVE his quote " I see the lung as our tool, not as a potential danger." I am quite fond of this one: :-)
"I remember the launches of Humalog (in 1996) and having individuals come back to me and say, “I don’t know what you’ve done, but I want a refill on that insulin because it changed my meal-time experience.” I think Afrezza can do the same in a way we haven’t seen since then."When Humalog came along, it was such a positive change in my life, I called it a "partial cure" because i could live a more normal life. After using Afrezza for almost three years now.....Afrezza is far, far superior in helping me lead a much, much more normal life. |
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Post by agedhippie on Mar 2, 2018 18:41:24 GMT -5
DBC - I for one am expecting them to go way beyond what's on the label. Good Grief, if thats what they are doing its no surprise we have 400 scripts a week. Next week they all need to be briefed on the 118 trial for starteres and they better have all the info highlighted here including all studies done pharmatips.in/Articles/Pharma-Marketing/What-Doctors-Expect-From-Medical-Representative.aspx Going beyond the label is illegal under the Food, Drug and Cosmetic Act and exposes the company to both criminal and civil risk. There have been some eye-watering settlements from this. |
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Post by dreamboatcruise on Mar 2, 2018 18:44:54 GMT -5
DBC - I for one am expecting them to go way beyond what's on the label. Good Grief, if thats what they are doing its no surprise we have 400 scripts a week. Next week they all need to be briefed on the 118 trial for starteres and they better have all the info highlighted here including all studies done Precisely... and here we sit at 400. Unfortunately those are the constraints of the FDA. Maybe you can get in touch with a pharma rep and ask about this point if you don't believe it. |
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