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Post by careful2invest on Feb 19, 2017 14:57:39 GMT -5
Mango, you are assuming bad intentions, you claim they mentioned inhaled insulin as an afterthought, and you claim to know what the authors were thinking. Probably no one else here has read or has access to the actual article. I'm not quite sure what your intentions are. I do not claim to be able to read anyones mind, but if AFREZZA actually works as well as the many patients that are using it claim, wouldn't one tend to believe that people in the healing industry would be embracing it. AFREZZA mimics a healthy human pancreas, only monomer insulin, Lowering AIC, longer time in range, no needles, Diabetics can eat whatever they want (within reason) etc... It seem clear, and this is not news, Phamaceutical companies (in general) are not in the healing business. They are into the business of selling their product! Unfortunately for us, AFREZZA is not their product and it appears, (and is reinforced by mangos post) that the docs at this seminar (that have the power to move the needle) already have long ties to current producers of the outdated treatments of Diabetes strong enough to shrug and even shunn the replacement for the best treatment of Diabetes that is AFREZZA! We have a huge challenge ahead! MNKD needs to find someone infuential enough to break down this nearly impenetrable wall! Can the union with JDRF be enough? IDK?
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Post by careful2invest on Feb 19, 2017 15:30:34 GMT -5
Wow. Afrezza has a steep uphill battle. $$$$$ is the great motivator in our health care system. My questions to Mango: 1. Have you shared this information with MNKD management so there is NO DOUBT that they are aware? 2. If so, what was their response and action plan to combat this "recommendation" (publication) to the practitioners? I appreciate all the informative information you post. Too bad a investigative news show, like 60 Minutes, can't expose how $$$$$ is influencing our medical care givers. You would think they would jump on a story like this, especially since drug pricing has been in news lately. 1. Have you shared this information with MNKD management so there is NO DOUBT that they are aware?No. I honestly do not know how to convey all this information in a precise and condensed way, and for it to be informative and slap the point across that an executive would take the time to read and understand. I hope someone else can take the task of doing so. If not, someone can just tweet Mike to read the thread. 2. If so, what was their response and action plan to combat this "recommendation" (publication) to the practitioners?Who knows if MannKind will even share the same views. Mango, IMHO, Convey this information just as you did on this mb! Your perspective, (backed by proof) is very convincing! However, I honestly hope that MNKD is fully aware of this information, because if not, they are alarmingly inept! For MNKD not to be involved (at any capacity)in a seminar called "2017 Endo Concensus on T2D" alarms the crap out of me! Were they not permitted? That would be the only acceptable reason for MNKD not being there with bells on! Or with at least some spokesperson or group! It has been odd to all (or most) of us that MNKD has done little to no advertising promotion of AFREZZA, agreed? For MNKD not to be at a worldwide annual convention that is covering the treatments of Diabetes shows that making excuses for MNKD is over. At least from my perspective! They have missed opportunity after missed opportunity to spread the word about AFREZZA! It's almost as if they do not want to! It just does not make sense!
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Post by agedhippie on Feb 19, 2017 16:01:27 GMT -5
It's a consensus paper and consensus changes slowly - get over it. I love this in particular: — It is difficult not to cite that paper, it's the standard paper on the topic! Is there a rule that you cannot cite a highly cited paper (877 other papers cited it) if you were an author? If so that's a rule that's been ignored forever. There is no ethical duty breach regardless of what you might think. How is a paper over a decade old "the standard" paper on the topic when it does not even include the most advanced modern day prandial insulin, Afrezza? Hello? Waiting for that answer. In the meantime while you try to think of a clever rebuttal, yes, there is an ethical breach as is evidenced by the disclosures and if you want to argue on that point then you will be aguing with yourself. Again, how is that paper even relevant and considered as the CURRENT standard when it is OUTDATED and does not have CURRENT and RELEVANT information?!?!? Also, WHERE IS THE REFERENCE TO INHALED INSULIN AKA AFREZZA??? I can't really believe I am discussing this but it's a lazy Sunday afternoon so here goes. Is a paper over a decade old the standard paper on the difference between Regular and RAA? Yes it is. Remember how long ago RAA came out? There is not exactly a pressing need to revisit the topic. Inhaled insulin is mentioned several times in conjunction with RAA. You might not like that, but until there are trials showing superiority that's as good as it gets - I would have thought people would have understood that by now. If you want Afrezza to be asserted as superior in these documents (and who doesn't) then Mannkind needs to step up and do the trials, anecdotal evidence doesn't cut it. As Matt points out if you are a thought leader then pharmas will seek you out for advice. Since this is your time they are using they pay for that time just as I would as a patient. If you want to exclude anyone who has received funding from pharmas then you have taken out almost all the brightest and the best. That's is not a good approach for standards of care.
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Post by sayhey24 on Feb 19, 2017 16:02:19 GMT -5
Are you suggesting a lawsuit based on pay for play? Considering afrezza is the ONLY product which mimics 1st phase pancreatic insulin release it seems more than odd all these experts don't know what afrezza does. It would be interesting go through the discover process. If they honestly don't know, they will after being deposed.
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Post by cm5 on Feb 19, 2017 16:11:08 GMT -5
Words----so much fun food for thought--
Thought Leader = Group Think Leader
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Post by agedhippie on Feb 19, 2017 17:07:32 GMT -5
Are you suggesting a lawsuit based on pay for play? Considering afrezza is the ONLY product which mimics 1st phase pancreatic insulin release it seems more than odd all these experts don't know what afrezza does. It would be interesting go through the discover process. If they honestly don't know, they will after being deposed. It doesn't matter how it works, what matters is the trial data and that data brackets RAA with Afrezza. This is really simple, they cannot ignore trial data. That's it - end of story.
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Post by slugworth008 on Feb 19, 2017 18:14:08 GMT -5
Oops, didn't notice the link. Sorry mango. No worries. I am just pissed off at the discovery of this. It is up to MannKind now, and whether they even read these kind of publications, I have no clue. I would be knocking on the door first thing Monday morning if I were CEO Matt. I absolutely agree with you - MNKD needs to be engaged with what is and is not being said in publications and respond intelligently and aggressively. IMO - Furthermore I hope they are knocking on the doors of sympathetic Senators and watch dog groups to rebuff the insulin cartel. Perhaps : Take a Trump like approach to the "fake news media" - I use this only as an example.
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Post by mango on Feb 19, 2017 22:01:18 GMT -5
How is a paper over a decade old "the standard" paper on the topic when it does not even include the most advanced modern day prandial insulin, Afrezza? Hello? Waiting for that answer. In the meantime while you try to think of a clever rebuttal, yes, there is an ethical breach as is evidenced by the disclosures and if you want to argue on that point then you will be aguing with yourself. Again, how is that paper even relevant and considered as the CURRENT standard when it is OUTDATED and does not have CURRENT and RELEVANT information?!?!? Also, WHERE IS THE REFERENCE TO INHALED INSULIN AKA AFREZZA??? I can't really believe I am discussing this but it's a lazy Sunday afternoon so here goes. Is a paper over a decade old the standard paper on the difference between Regular and RAA? Yes it is. Remember how long ago RAA came out? There is not exactly a pressing need to revisit the topic. Inhaled insulin is mentioned several times in conjunction with RAA. You might not like that, but until there are trials showing superiority that's as good as it gets - I would have thought people would have understood that by now. If you want Afrezza to be asserted as superior in these documents (and who doesn't) then Mannkind needs to step up and do the trials, anecdotal evidence doesn't cut it. As Matt points out if you are a thought leader then pharmas will seek you out for advice. Since this is your time they are using they pay for that time just as I would as a patient. If you want to exclude anyone who has received funding from pharmas then you have taken out almost all the brightest and the best. That's is not a good approach for standards of care.You still have not given me a sound argument, and most definitely have not presented any evidence suggesting your opinions hold any weight. I am going to present this in an entirely different manner. Perhaps this perspective will be one that everyone can understand and grasp. There is an imaginary Endocrinologist A that just read this consensus and is asking another imaginary Endocrinologist B, who also just read it, specific questions about it. · What is lispro, aspart, and glulisine Endocrinologist B? —Why, Rapid-acting insulin analogs of course! · What about this inhaled insulin? The Consensus mentions it twice. What is it and how is it different? —I have no idea. The Consensus only mentions the words 'inhaled insulin', and does not provide us with a description. · Oh...Well, what are the references to the inhaled insulin so I can learn more about it? —Unfortunately, The Consensus did not provide any references to the inhaled insulin. · What about reference (149) authored by Dr. Hirsch whom is also a part of The Consensus? Since Dr. Hirsch's publication is referenced to the inhaled insulin, and Dr. Hirsch is on The Consensus, surely it provides us with an abundance of information about this inhaled insulin that we have never heard of?! —Unfortunately, Dr. Hirsch's publication that is used as a reference to the inhaled insulin dates back to 2005, and it is now the year of 2017. Nonetheless, it is not in the publication The Consensus used as the reference to the inhaled insulin. · What about Dr. Janet McGill? Wasn't she a Clinical Investigator for something called Afrezza? Maybe she has a reference that could lead us to finding out about this inhaled insulin! —Unfortunately, Dr. Janet McGill does not. In fact, none of the pharmaceutical companies that are in the financial disclosures with The Consensus have an inhaled insulin. · I wonder why The Consensus does not want us to find out about the inhaled insulin? —Me too Endocrinologist A. I sure do have a ton of patients that hate all these needle injections...
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Post by babaoriley on Feb 20, 2017 0:49:19 GMT -5
Nice, Mango, but I honestly cannot see two endos having such a discussion. They probably spend more time talking the ACA, and the possible repeal thereof, and what effect that may have on their practices. And I can't blame them for having that discussion. Endos probably feel they know their area sufficiently (although they don't), and I don't see them engaging in much, if any, discussion.
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Post by falconquest on Feb 20, 2017 6:29:20 GMT -5
I can't really believe I am discussing this but it's a lazy Sunday afternoon so here goes. Is a paper over a decade old the standard paper on the difference between Regular and RAA? Yes it is. Remember how long ago RAA came out? There is not exactly a pressing need to revisit the topic. Inhaled insulin is mentioned several times in conjunction with RAA. You might not like that, but until there are trials showing superiority that's as good as it gets - I would have thought people would have understood that by now. If you want Afrezza to be asserted as superior in these documents (and who doesn't) then Mannkind needs to step up and do the trials, anecdotal evidence doesn't cut it. As Matt points out if you are a thought leader then pharmas will seek you out for advice. Since this is your time they are using they pay for that time just as I would as a patient. If you want to exclude anyone who has received funding from pharmas then you have taken out almost all the brightest and the best. That's is not a good approach for standards of care.You still have not given me a sound argument, and most definitely have not presented any evidence suggesting your opinions hold any weight. I am going to present this in an entirely different manner. Perhaps this perspective will be one that everyone can understand and grasp. There is an imaginary Endocrinologist A that just read this consensus and is asking another imaginary Endocrinologist B, who also just read it, specific questions about it. · What is lispro, aspart, and glulisine Endocrinologist B? —Why, Rapid-acting insulin analogs of course! · What about this inhaled insulin? The Consensus mentions it twice. What is it and how is it different? —I have no idea. The Consensus only mentions the words 'inhaled insulin', and does not provide us with a description. · Oh...Well, what are the references to the inhaled insulin so I can learn more about it? —Unfortunately, The Consensus did not provide any references to the inhaled insulin. · What about reference (149) authored by Dr. Hirsch whom is also a part of The Consensus? Since Dr. Hirsch's publication is referenced to the inhaled insulin, and Dr. Hirsch is on The Consensus, surely it provides us with an abundance of information about this inhaled insulin that we have never heard of?! —Unfortunately, Dr. Hirsch's publication that is used as a reference to the inhaled insulin dates back to 2005, and it is now the year of 2017. Nonetheless, it is not in the publication The Consensus used as the reference to the inhaled insulin. · What about Dr. Janet McGill? Wasn't she a Clinical Investigator for something called Afrezza? Maybe she has a reference that could lead us to finding out about this inhaled insulin! —Unfortunately, Dr. Janet McGill does not. In fact, none of the pharmaceutical companies that are in the financial disclosures with The Consensus have an inhaled insulin. · I wonder why The Consensus does not want us to find out about the inhaled insulin? —Me too Endocrinologist A. I sure do have a ton of patients that hate all these needle injections... .....and Endo's don't use Google?
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Post by od on Feb 20, 2017 11:22:11 GMT -5
If I recall correctly that Matt and Mike said MannKind engaged opinion leaders after the Sanofi breakup, you can be sure there will be 'matched' data for 2017, and probably 2016. I believe the data is only current through 2015.
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Post by akemp3000 on Feb 20, 2017 11:48:45 GMT -5
Excellent idea. A lawsuit would also increase public exposure. If everyone is exposed to both sides of this argument, Afrezza wins. The downside is if the court system is also corrupt, i.e. 9th Circus Court...but we all know that's not possible...said sarcastically.
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Post by peppy on Feb 20, 2017 12:27:15 GMT -5
Regarding, Exposing the Corruption of the 2017 Endo Consensus on T2D Afrezza delivers insulin in a manner that makes it an ideal choice for treating type 2 diabetes (T2D). The loss of early firstphase insulin release, a hallmark of T2D,5 leads to inadequate suppression of endogenous glucose production (EGP) and early postprandial hyperglycemia.6,7 For patients early in the progression of T2D, when A1C is less than 7.3%, postprandial glucose excursions are the major component of overall hyperglycemia.8 Not only can Afrezza, with its rapid absorption, complement the patient’s late-phase insulin release, but it also has been shown to suppress EGP earlier than SC lispro.9 Thus, there might be a therapeutic advantage to using Afrezza as the initial treatment early in T2D, particularly for patients whose insulin timing is faulty (ie, patients who have diminished early insulin response but retain some beta cell function). ajmc.s3.amazonaws.com/_media/_pdf/EBDM0916.pdfDisclosures: The author serves on the advisory board on insulin for Novo Nordisk.
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Post by mango on Feb 20, 2017 18:10:50 GMT -5
If I recall correctly that Matt and Mike said MannKind engaged opinion leaders after the Sanofi breakup, you can be sure there will be 'matched' data for 2017, and probably 2016. I believe the data is only current through 2015. I believe this is what you are speaking of? "Frank is an integral addition to our Clinical Development and Medical Affairs team as we continue to build medical affairs capabilities and infrastructure," said Dr. Raymond Urbanski. "He has immediate responsibility for MannKind's medical science liaisons, reaching out to key opinion leaders, managing our medical information platform, and developing and executing our Afrezza medical affairs strategy. I am excited to have Frank's extensive industry experience at MannKind." investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=982075· As cm5 pointed out, there is a fundamental difference between a pharmaceutical company paying out over 100 million dollars a year to physicians in efforts to control the market space through biased speeches, presentations, publications, events (CME), and even neglecting to acknowledge and/or prescribe certain medications in practice that are not in the best interests of those pharmaceutical companies that are providing said physicians with a beyond lucrative and unethical compensation. · You can filter through all the publications on Afrezza and Technosphere yourself and look at the disclosures to determine what financial interests are involved, if any, and whether they are sound or unethical. You don't have to wait for an independent entity to compile the data for you. · Here is an example of MannKind being involved in the funding of a publication on Technosphere Insulin (Afrezza), which was merely them paying the processing charges for the publication. Sanofi paid the authors. Ironically, this article is from 2016 and features none other than the former Clinical Trial Investigator for Afrezza and contributing author of The Official Consensus---Dr. Janet B. McGill. Making Insulin Accessible: Does Inhaled Insulin Fill an Unmet Need?---"Glycemic control is fundamental to the management of diabetes. However, studies suggest that a significant proportion of people with diabetes, particularly those using insulin, are not achieving glycemic targets. The reasons for this are likely to be multifactorial. The real and perceived risk of hypoglycemia and the need for multiple daily injections are widely recognized as key barriers to effective insulin therapy. Therefore, there is a clear unmet need for a treatment option which can help mitigate these barriers. Alternative methods of insulin administration have been under investigation for several years, and pulmonary delivery has shown the most promise to date. Inhaled Technosphere® Insulin (TI; Afrezza®; MannKind Corporation) was approved in 2014 for use as prandial insulin in people with diabetes. TI shows a more rapid onset of action and a significantly faster decline in activity than current subcutaneous rapid-acting insulin analogs (RAAs), and TI is more synchronized to the physiologic timing of the postprandial glucose excursion. This results in lower postprandial hypoglycemia with similar glycemic control compared with RAAs, and less weight gain. Together with the ease of use of the TI inhaler and the reduction in the number of daily injections, these findings imply that TI may be useful in helping to overcome patient resistance to insulin, improve adherence and mitigate clinical inertia in health-care providers, with potential beneficial effects on glycemic control." ---Funding: Writing and editorial support in the preparation of this publication was funded by Sanofi US, Inc., Bridgewater, New Jersey, USA. Funding for the article processing charges for this publication was provided by MannKind Corporation. link.springer.com/article/10.1007%2Fs12325-016-0370-1· Now, how in the world do you go from publishing information such as that to the load of BS in the publication The Committee on The Official Consensus Position of the American Association of Clinical Endocrinologists and American College of Endocrinology? By being paid off. If I had the time I would post every publication contradicting the official position of The Consensus Committee, but I feel the facts that I have contributed so far should be more than suffice to support the obvious---The official position of the committee is biased, unethical, and do not represent the best interests of the patient, nor appropriately acknowledge the most advanced present day diabetes prandial insulin therapy, which Dr. Janet B. McGill herself even backed up in the 2016 article above as being the most innovative alternative for diabetics to date. Let's see that statement again: ---" Alternative methods of insulin administration have been under investigation for several years, and pulmonary delivery has shown the most promise to date...TI shows a more rapid onset of action and a significantly faster decline in activity than current subcutaneous rapid-acting insulin analogs (RAAs), and TI is more synchronized to the physiologic timing of the postprandial glucose excursion. This results in lower postprandial hypoglycemia with similar glycemic control compared with RAAs, and less weight gain."
· For anyone to defend the committees' official position would be deliberately endorsing misinformation. A physician committee author stamped her name on the publication above stating facts which completely contradict The Official Consensus Statements made on mealtime prandial insulin in its entirety. As the publication clearly states: "Every effort was made to achieve consensus among the committee members."· Here is the committees' official position statement on prandial insulin again for easy comparison: ---"Patients whose glycemia remains uncontrolled while receiving basal insulin alone or in combination with oral agents may require mealtime insulin to cover postprandial hyperglycemia. Rapid-acting analogs (lispro, aspart, or glulisine) or inhaled insulin are preferred over regular human insulin because the former have a more rapid onset and offset of action and are associated with less hypoglycemia (149). Prandial insulin should be considered when the total daily dose of basal insulin is greater than 0.5 U/ kg. Beyond this dose, the risk of hypoglycemia increases markedly without signi cant bene t in reducing A1C (150). The simplest approach is to cover the largest meal with a prandial injection of a rapid-acting insulin analog or inhaled insulin and then add additional mealtime insulin later, if needed. Several randomized controlled trials have shown that the stepwise addition of prandial insulin to basal insulin is safe and effective in achieving target A1C with a low rate of hypoglycemia (151-153). A full basal-bolus program is the most effective insulin regimen and provides greater exibility for patients with variable mealtimes and meal carbohydrate content, although this type of program has been associated with weight gain (153)."
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Post by sayhey24 on Feb 20, 2017 18:33:17 GMT -5
Are you suggesting a lawsuit based on pay for play? Considering afrezza is the ONLY product which mimics 1st phase pancreatic insulin release it seems more than odd all these experts don't know what afrezza does. It would be interesting go through the discover process. If they honestly don't know, they will after being deposed. It doesn't matter how it works, what matters is the trial data and that data brackets RAA with Afrezza. This is really simple, they cannot ignore trial data. That's it - end of story. You are correct 171 did bracket it with the RAA's. I have said it before and I will say it again, MNKD agreeing to this trial design was a HUGE mistake. However the clamp studies do provide the ability for MNKD to now pivot and overlay pancreas secretes insulin with the clamp study results and tell the story RAA's are not only NOT rapid they do not provide the same phase 1 response both afrezza and a healthy pancreas provide. Lets see what the new label will look like, we should know soon. www.mannkindcorp.com/assets/Baughman-2016-TI-displays-earlier-onset-and-shorter-duration-than-insulin-lispro-ADA-100-LB.pdf
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