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Post by mango on Nov 3, 2021 10:19:38 GMT -5
The Management of Type 1 Diabetes in Adults. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)Once again, without fail, we see the blatant corruption and bias of ADA on Afrezza inhaled insulin. Below is the only mentions of Afrezza. Absolutely pathetic is an understatement. We have a plethora of data from clinical trials supporting much more than the disrespectful, inaccurate and incomplete descriptions of Afrezza portrayed by ADA below. This is, once again, a direct consequence of MannKind choosing to not participate in the ADA Pay-to-Play Scheme and the enormous potential loss in market share by competitors who actively Pay-to-Play. You will also notice ADA’s use of “ultra rapid acting insulin analogs.” Another false and inaccurate use of language. These people should be criminally and ethically charged. This is preposterous! Afrezza has been proven by direct observation and experiment to be the world’s only ultra rapid acting insulin and the world’s only mealtime insulin that mimics endogenous prandial insulin. 1. In the U.S., inhaled human insulin is an alternative to subcutaneous rapid-acting analogs (3). 2. Inhaled human insulin, available only in the U.S., has a very rapid onset of action and short duration compared with subcutaneous rapid-acting analogs (3). Inhaled insulin ameliorates early postprandial hyperglycemia well, but its short duration of action results in less control of later postprandial hyperglycemia. Additionally, inhaled insulin can cause cough or sore throat, and therapy must be monitored with periodic spirometry because of possible effects on lung function (97). Funding. The report was jointly commissioned and funded by the ADA and EASD. The authors did not receive any payment for their involvement in the writing group. Duality of Interest. R.I.G.H. serves on the speakers’ bureau for and receives research support from Novo Nordisk. He serves on the speakers’ bureau for Abbott, Eli Lilly, Otsuka, and Roche. He also served as the Editor-in-Chief of Diabetic Medicine until December 2020. J.H.D. received research funding from Afon, Eli Lilly, and Novo Nordisk. He served on advisory boards for Adocia, Novo Nordisk, and Zealand Pharma and was on a speaker’s bureau for Novo Nordisk. A.H.-F. is an auditor for the ADA’s Education Recognition Program. She is a participant in a speaker’s bureau for Abbott Diabetes Care and Xeris. She is also a member of Xeris’ advisory board. I.B.H. receives industry research funding from Medtronic Diabetes, Insulet, and Beta Bionics. He is a consultant for Bigfoot, Roche, and Abbott Diabetes Care. M.S.K. receives research funding from Novo Nordisk and Bayer. T.K. has served on advisory boards for Abbott, Ascensia, Bioton, Boehringer Ingelheim, Dexcom, Eli Lilly, Medtronic, Roche, Sanofi, and Ypsomed. He has received research funding from Medtronic and is a participant in a speakers’ bureau for Abbott, Ascensia, Bioton, Boehringer Ingelheim, Eli Lilly, Medtronic, Novo Nordisk, Roche, Sanofi, and Servier. B.L. declares that there are no relationships or activities that might bias, or be perceived to bias, their work. K.N. receives research funding from, is a member of the advisory board for, and is a stockholder in Novo Nordisk. She is an advisory board member for Medtronic and Abbott Diabetes Care and receives research funding from Dexcom, Medtronic, and Zealand Pharma. J.P. is a consultant to Sanofi, Novo Nordisk, Eli Lilly, Zealand, Mannkind, and Diasome. E.R. serves on the advisory board for Abbott, Air Liquide SI, Dexcom, Insulet, Sanofi, Roche, Novo Nordisk, and Eli Lilly, and received research support from Dexcom and Tandem. J.S.S. is a member of the board of directors for Applied Therapeutics and Dexcom. He serves on the scientific advisory board for Abvance, ActoBiotics, Adocia, Avotres, Oramed, Orgenesis, Sanofi Diabetes, Tolerion, and Viacyte. He received research support from Tolerion. He is an advisor and consultant to Boehringer Ingelheim, Dance Biopharm/Aerami Therapeutics, Enthera, Ideal Life, Imcyse, Immnomolecular Therapeutics, Novo Nordisk, Provention Bio, Sanofi Diabetes, Signos, Tolerion, and VielaBio. He is a shareholder or option holder in Abvance, Avotres, Dance Biopharm/Aerami Therapeutics, Dexcom, Ideal Life, Immnomolecular Therapeutics, Oramed, and Orgenesis. F.J.S. is consultant to Abbott, Eli Lilly, Sanofi, and Novo Nordisk, and serves on the speakers’ bureau for Abbott, Eli Lilly, Sanofi, and Novo Nordisk. He has received research funding from Sanofi and Novo Nordisk. R.S.W. receives research funding from Eli Lilly, Medtronic, Insulet, Diasome, Kowa, Tolerion, Novo Nordisk, and Boehringer Ingelheim. A.L.P. serves on the advisory board for Abbott Diabetes Care, Eli Lilly, Novo Nordisk, Medscape, and Zealand Pharmaceuticals. She has received research support from Dexcom and Insulet and has received donated devices from Abbott Diabetes Care. She also has stock options from Omada Health and Livongo and is a special government employee of the FDA. No other potential conflicts of interest relevant to this article were reported. care.diabetesjournals.org/content/44/11/2589
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Post by sayhey24 on Nov 3, 2021 11:03:10 GMT -5
I am not sure what they said was incorrect. It does have a very rapid onset of action and short duration compared with subcutaneous rapid-acting analogs. They could have mentioned that this fast on/off results in lower hypoglycemia which has always been the great fear with the use of insulin. They did mention it ameliorates early postprandial hyperglycemia well. This has been a big area of use with T1s, basically as a rescue tool to knock down highs.
The cough will always be a red-herring and it sure did not seem to be a big deal with Tyvsaso. It would have been nice if they mentioned while periodic spirometry is required some patients have seen improved lung function.
IMO spending a lot of time with the T1s may not be time well spent. Afrezza as a game changer is with the T2s. It should be the 1st step in the SoC. With a number of companies like Levels now promoting the use of CGMs for diet, the next natural step with them will be moving into not only monitoring glucose spikes but addressing the spike. While diet is nice it has its limits and a lot of their clients have diabetes and may not even know it. IMO afrezza will be the holy grail for these companies and they have no connection to the ADA or what they say. They could care less about the ADA. They are already using CGMs off label for diet monitoring.
What we have learned over the years is trying to get real changes with the ADA with afrezza is not happening. Dave Kendall's easiest job ever ended up being not so easy.
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Post by sr71 on Nov 3, 2021 11:12:42 GMT -5
The Management of Type 1 Diabetes in Adults. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)Once again, without fail, we see the blatant corruption and bias of ADA on Afrezza inhaled insulin. Below is the only mentions of Afrezza. Absolutely pathetic is an understatement. We have a plethora of data from clinical trials supporting much more than the disrespectful, inaccurate and incomplete descriptions of Afrezza portrayed by ADA below. This is, once again, a direct consequence of MannKind choosing to not participate in the ADA Pay-to-Play Scheme and the enormous potential loss in market share by competitors who actively Pay-to-Play. You will also notice ADA’s use of “ultra rapid acting insulin analogs.” Another false and inaccurate use of language. These people should be criminally and ethically charged. This is preposterous! Afrezza has been proven by direct observation and experiment to be the world’s only ultra rapid acting insulin and the world’s only mealtime insulin that mimics endogenous prandial insulin. 1. In the U.S., inhaled human insulin is an alternative to subcutaneous rapid-acting analogs (3). 2. Inhaled human insulin, available only in the U.S., has a very rapid onset of action and short duration compared with subcutaneous rapid-acting analogs (3). Inhaled insulin ameliorates early postprandial hyperglycemia well, but its short duration of action results in less control of later postprandial hyperglycemia. Additionally, inhaled insulin can cause cough or sore throat, and therapy must be monitored with periodic spirometry because of possible effects on lung function (97). Funding. The report was jointly commissioned and funded by the ADA and EASD. The authors did not receive any payment for their involvement in the writing group. Duality of Interest. R.I.G.H. serves on the speakers’ bureau for and receives research support from Novo Nordisk. He serves on the speakers’ bureau for Abbott, Eli Lilly, Otsuka, and Roche. He also served as the Editor-in-Chief of Diabetic Medicine until December 2020. J.H.D. received research funding from Afon, Eli Lilly, and Novo Nordisk. He served on advisory boards for Adocia, Novo Nordisk, and Zealand Pharma and was on a speaker’s bureau for Novo Nordisk. A.H.-F. is an auditor for the ADA’s Education Recognition Program. She is a participant in a speaker’s bureau for Abbott Diabetes Care and Xeris. She is also a member of Xeris’ advisory board. I.B.H. receives industry research funding from Medtronic Diabetes, Insulet, and Beta Bionics. He is a consultant for Bigfoot, Roche, and Abbott Diabetes Care. M.S.K. receives research funding from Novo Nordisk and Bayer. T.K. has served on advisory boards for Abbott, Ascensia, Bioton, Boehringer Ingelheim, Dexcom, Eli Lilly, Medtronic, Roche, Sanofi, and Ypsomed. He has received research funding from Medtronic and is a participant in a speakers’ bureau for Abbott, Ascensia, Bioton, Boehringer Ingelheim, Eli Lilly, Medtronic, Novo Nordisk, Roche, Sanofi, and Servier. B.L. declares that there are no relationships or activities that might bias, or be perceived to bias, their work. K.N. receives research funding from, is a member of the advisory board for, and is a stockholder in Novo Nordisk. She is an advisory board member for Medtronic and Abbott Diabetes Care and receives research funding from Dexcom, Medtronic, and Zealand Pharma. J.P. is a consultant to Sanofi, Novo Nordisk, Eli Lilly, Zealand, Mannkind, and Diasome. E.R. serves on the advisory board for Abbott, Air Liquide SI, Dexcom, Insulet, Sanofi, Roche, Novo Nordisk, and Eli Lilly, and received research support from Dexcom and Tandem. J.S.S. is a member of the board of directors for Applied Therapeutics and Dexcom. He serves on the scientific advisory board for Abvance, ActoBiotics, Adocia, Avotres, Oramed, Orgenesis, Sanofi Diabetes, Tolerion, and Viacyte. He received research support from Tolerion. He is an advisor and consultant to Boehringer Ingelheim, Dance Biopharm/Aerami Therapeutics, Enthera, Ideal Life, Imcyse, Immnomolecular Therapeutics, Novo Nordisk, Provention Bio, Sanofi Diabetes, Signos, Tolerion, and VielaBio. He is a shareholder or option holder in Abvance, Avotres, Dance Biopharm/Aerami Therapeutics, Dexcom, Ideal Life, Immnomolecular Therapeutics, Oramed, and Orgenesis. F.J.S. is consultant to Abbott, Eli Lilly, Sanofi, and Novo Nordisk, and serves on the speakers’ bureau for Abbott, Eli Lilly, Sanofi, and Novo Nordisk. He has received research funding from Sanofi and Novo Nordisk. R.S.W. receives research funding from Eli Lilly, Medtronic, Insulet, Diasome, Kowa, Tolerion, Novo Nordisk, and Boehringer Ingelheim. A.L.P. serves on the advisory board for Abbott Diabetes Care, Eli Lilly, Novo Nordisk, Medscape, and Zealand Pharmaceuticals. She has received research support from Dexcom and Insulet and has received donated devices from Abbott Diabetes Care. She also has stock options from Omada Health and Livongo and is a special government employee of the FDA. No other potential conflicts of interest relevant to this article were reported. care.diabetesjournals.org/content/44/11/2589 And they conveniently forgot to mention that Afrezza is also available in Brazil (see bolded and enlarged passage above), and they contend that "the very rapid onset of action" is a bad thing. The authors obviously didn't do their homework. |
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Post by dh4mizzou on Nov 3, 2021 11:20:14 GMT -5
Isn't this something that MNKD can and SHOULD refute publicly?
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Post by peppy on Nov 3, 2021 11:25:18 GMT -5
Continuous Glucose Monitors makes a Rapid insulin analog 2 hour onset and a 5 hour tail easier to see.  The thingy didn't mention the chitty control of the subq rapid acting analogs. Yes, Afrezza takes follow up doses, however, I hear people feel better.  Sometimes, seeing is believing.  Same stick, different day.  |
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Post by mango on Nov 3, 2021 11:30:58 GMT -5
The Management of Type 1 Diabetes in Adults. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)Once again, without fail, we see the blatant corruption and bias of ADA on Afrezza inhaled insulin. Below is the only mentions of Afrezza. Absolutely pathetic is an understatement. We have a plethora of data from clinical trials supporting much more than the disrespectful, inaccurate and incomplete descriptions of Afrezza portrayed by ADA below. This is, once again, a direct consequence of MannKind choosing to not participate in the ADA Pay-to-Play Scheme and the enormous potential loss in market share by competitors who actively Pay-to-Play. You will also notice ADA’s use of “ultra rapid acting insulin analogs.” Another false and inaccurate use of language. These people should be criminally and ethically charged. This is preposterous! Afrezza has been proven by direct observation and experiment to be the world’s only ultra rapid acting insulin and the world’s only mealtime insulin that mimics endogenous prandial insulin. 1. In the U.S., inhaled human insulin is an alternative to subcutaneous rapid-acting analogs (3). 2. Inhaled human insulin, available only in the U.S., has a very rapid onset of action and short duration compared with subcutaneous rapid-acting analogs (3). Inhaled insulin ameliorates early postprandial hyperglycemia well, but its short duration of action results in less control of later postprandial hyperglycemia. Additionally, inhaled insulin can cause cough or sore throat, and therapy must be monitored with periodic spirometry because of possible effects on lung function (97). Funding. The report was jointly commissioned and funded by the ADA and EASD. The authors did not receive any payment for their involvement in the writing group. Duality of Interest. R.I.G.H. serves on the speakers’ bureau for and receives research support from Novo Nordisk. He serves on the speakers’ bureau for Abbott, Eli Lilly, Otsuka, and Roche. He also served as the Editor-in-Chief of Diabetic Medicine until December 2020. J.H.D. received research funding from Afon, Eli Lilly, and Novo Nordisk. He served on advisory boards for Adocia, Novo Nordisk, and Zealand Pharma and was on a speaker’s bureau for Novo Nordisk. A.H.-F. is an auditor for the ADA’s Education Recognition Program. She is a participant in a speaker’s bureau for Abbott Diabetes Care and Xeris. She is also a member of Xeris’ advisory board. I.B.H. receives industry research funding from Medtronic Diabetes, Insulet, and Beta Bionics. He is a consultant for Bigfoot, Roche, and Abbott Diabetes Care. M.S.K. receives research funding from Novo Nordisk and Bayer. T.K. has served on advisory boards for Abbott, Ascensia, Bioton, Boehringer Ingelheim, Dexcom, Eli Lilly, Medtronic, Roche, Sanofi, and Ypsomed. He has received research funding from Medtronic and is a participant in a speakers’ bureau for Abbott, Ascensia, Bioton, Boehringer Ingelheim, Eli Lilly, Medtronic, Novo Nordisk, Roche, Sanofi, and Servier. B.L. declares that there are no relationships or activities that might bias, or be perceived to bias, their work. K.N. receives research funding from, is a member of the advisory board for, and is a stockholder in Novo Nordisk. She is an advisory board member for Medtronic and Abbott Diabetes Care and receives research funding from Dexcom, Medtronic, and Zealand Pharma. J.P. is a consultant to Sanofi, Novo Nordisk, Eli Lilly, Zealand, Mannkind, and Diasome. E.R. serves on the advisory board for Abbott, Air Liquide SI, Dexcom, Insulet, Sanofi, Roche, Novo Nordisk, and Eli Lilly, and received research support from Dexcom and Tandem. J.S.S. is a member of the board of directors for Applied Therapeutics and Dexcom. He serves on the scientific advisory board for Abvance, ActoBiotics, Adocia, Avotres, Oramed, Orgenesis, Sanofi Diabetes, Tolerion, and Viacyte. He received research support from Tolerion. He is an advisor and consultant to Boehringer Ingelheim, Dance Biopharm/Aerami Therapeutics, Enthera, Ideal Life, Imcyse, Immnomolecular Therapeutics, Novo Nordisk, Provention Bio, Sanofi Diabetes, Signos, Tolerion, and VielaBio. He is a shareholder or option holder in Abvance, Avotres, Dance Biopharm/Aerami Therapeutics, Dexcom, Ideal Life, Immnomolecular Therapeutics, Oramed, and Orgenesis. F.J.S. is consultant to Abbott, Eli Lilly, Sanofi, and Novo Nordisk, and serves on the speakers’ bureau for Abbott, Eli Lilly, Sanofi, and Novo Nordisk. He has received research funding from Sanofi and Novo Nordisk. R.S.W. receives research funding from Eli Lilly, Medtronic, Insulet, Diasome, Kowa, Tolerion, Novo Nordisk, and Boehringer Ingelheim. A.L.P. serves on the advisory board for Abbott Diabetes Care, Eli Lilly, Novo Nordisk, Medscape, and Zealand Pharmaceuticals. She has received research support from Dexcom and Insulet and has received donated devices from Abbott Diabetes Care. She also has stock options from Omada Health and Livongo and is a special government employee of the FDA. No other potential conflicts of interest relevant to this article were reported. care.diabetesjournals.org/content/44/11/2589 And they conveniently forgot to mention that Afrezza is also available in Brazil (see bolded and enlarged passage above), and they contend that "the very rapid onset of action" is a bad thing. The authors obviously didn't do their homework. Precisely! They have an grossly incomplete and inaccurate description of Afrezza. The use of their language here, and also in the ADA SoC, is always worded in a way that makes Afrezza’s attributes appear to be a bad thing. If they could have completely omitted Afrezza from mention in the Consensus they would have! |
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Post by mango on Nov 3, 2021 11:53:20 GMT -5
I am not sure what they said was incorrect. It does have a very rapid onset of action and short duration compared with subcutaneous rapid-acting analogs. They could have mentioned that this fast on/off results in lower hypoglycemia which has always been the great fear with the use of insulin. They did mention it ameliorates early postprandial hyperglycemia well. This has been a big area of use with T1s, basically as a rescue tool to knock down highs. The cough will always be a red-herring and it sure did not seem to be a big deal with Tyvsaso. It would have been nice if they mentioned while periodic spirometry is required some patients have seen improved lung function. IMO spending a lot of time with the T1s may not be time well spent. Afrezza as a game changer is with the T2s. It should be the 1st step in the SoC. With a number of companies like Levels now promoting the use of CGMs for diet, the next natural step with them will be moving into not only monitoring glucose spikes but addressing the spike. While diet is nice it has its limits and a lot of their clients have diabetes and may not even know it. IMO afrezza will be the holy grail for these companies and they have no connection to the ADA or what they say. They could care less about the ADA. They are already using CGMs off label for diet monitoring. What we have learned over the years is trying to get real changes with the ADA with afrezza is not happening. Dave Kendall's easiest job ever ended up being not so easy. The language the authors used generally describes Afrezza’s attributes as a bad thing. This is not new—we see it every year in the various Consensus’ and ADA SoC. Furthermore, the authors claim Afrezza is only available in the USA. This is verifiably false. It is also available in Brazil. We have a mountain of data from direct observations and experiments that warrants further description of Afrezza than what is portrayed here by the authors. The condescending and back-handed tone the authors used when mentioning Afrezza is obvious and a complete joke. I’ve never seen a medical association so corrupt and bias in my life! This should be challenged but I doubt MannKind will do it. I wonder if someone like Bill and HfM would be able to. |
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Post by sayhey24 on Nov 3, 2021 13:46:02 GMT -5
I am not sure what they said was incorrect. It does have a very rapid onset of action and short duration compared with subcutaneous rapid-acting analogs. They could have mentioned that this fast on/off results in lower hypoglycemia which has always been the great fear with the use of insulin. They did mention it ameliorates early postprandial hyperglycemia well. This has been a big area of use with T1s, basically as a rescue tool to knock down highs. The cough will always be a red-herring and it sure did not seem to be a big deal with Tyvsaso. It would have been nice if they mentioned while periodic spirometry is required some patients have seen improved lung function. IMO spending a lot of time with the T1s may not be time well spent. Afrezza as a game changer is with the T2s. It should be the 1st step in the SoC. With a number of companies like Levels now promoting the use of CGMs for diet, the next natural step with them will be moving into not only monitoring glucose spikes but addressing the spike. While diet is nice it has its limits and a lot of their clients have diabetes and may not even know it. IMO afrezza will be the holy grail for these companies and they have no connection to the ADA or what they say. They could care less about the ADA. They are already using CGMs off label for diet monitoring. What we have learned over the years is trying to get real changes with the ADA with afrezza is not happening. Dave Kendall's easiest job ever ended up being not so easy. The language the authors used generally describes Afrezza’s attributes as a bad thing. This is not new—we see it every year in the various Consensus’ and ADA SoC. Furthermore, the authors claim Afrezza is only available in the USA. This is verifiably false. It is also available in Brazil. We have a mountain of data from direct observations and experiments that warrants further description of Afrezza than what is portrayed here by the authors. The condescending and back-handed tone the authors used when mentioning Afrezza is obvious and a complete joke. I’ve never seen a medical association so corrupt and bias in my life! This should be challenged but I doubt MannKind will do it. I wonder if someone like Bill and HfM would be able to. Agreed but as you say this is not new. These guys are not going to change. The ADA will do everything to block afrezza. Afrezza is a disruptive technology but its being hidden as best they can by the ADA which is really another name for BP. IMO its going to take someone outside the current players like a Google or an Amazon who sees how afrezza can be used to totally change how T2 diabetes is treated. I had high hopes for onduo.com and maybe one day Mike will get a partnership with someone like them. Maybe, it will be an insurance company who finally understands how properly treating T2s will dramatically reduce heart attacks, neuropathy, etc. which will dramatically reduce health costs. Clearly, some people like the new diet companies are just seeing the value of using CGMs to monitor AGPs. When I first met Mike I told him the only thing which would save afrezza was going to be technology such as CGMs. I never expected things would take so much time. The good news is every day is a day closer. Its a matter of time but I am afraid its going to take a lot more time. At the same time the ADA is not our friend. |
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Post by mnkdfann on Nov 3, 2021 20:14:43 GMT -5
Did anyone else notice that one of the authors is a consultant to Mannkind?
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Post by prcgorman2 on Nov 4, 2021 7:05:01 GMT -5
Did anyone else notice the last author is a “special government employee” of the FDA? That’s an interesting distinction. From memory that’s someone selected by the FDA (in this case) to consult at large. It is an influential position.
The lack of respect for the critically-important effect of ultra-rapid acting inhaled insulin in improving SAFETY for diabetics by reducing hypoglycemia underscores the need to emphasize this aspect of Afrezza above all else.
Hypoglycemia is the #1 reason doctors are told to avoid prescribing insulin. It’s the SAFETY, stupid. (To borrow a phrase from James Carville.)
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Post by mango on Nov 4, 2021 8:01:08 GMT -5
It appears what we have here is an attempt to discredit the scientific findings of Afrezza by omitting them altogether, and replacing them with an incredibly inaccurate, misleading, short, back-handed comment with a hint of truth thrown in.
Afrezza has been proven numerous times under direct observation and experiment to match physiologic insulin like that seen in a healthy, non-diabetic pancreas. Furthermore, it’s been demonstrated countless times over that Afrezza significantly reduces hypoglycemia compared to RAAs—which was deliberately neglected to be mentioned in the report. Additionally, the findings of Afrezza being weight neutral, not posing a risk for insulin-derived amyloidosis, and restoring post-prandial glucose homeostasis were all but mentioned in the Consensus as well.
There’s more we could add to the list, but it’s become apparent that ADA does not adhere to the scientific method and does not care for scientific evidence contrary to the amount of cash lining their pockets.
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