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Post by mango on Oct 6, 2018 10:04:12 GMT -5
ADA does not follow the scientific method and 'consensus' has no place in science. The ADA follow an evidence based approach and they lay out their methodology very clearly at the start of the Standard of Care. Until the rules are changed those are the rules everyone is playing under whether people like it or not. Are they the best, cleverest, smartest, whatever, rules? Probably not, but the thing is they are the rules so that's where we are. The SoC is bias and contains inaccurate and minimal information pertaining to Afrezza. |
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Post by sayhey24 on Oct 6, 2018 11:46:57 GMT -5
ADA does not follow the scientific method and 'consensus' has no place in science. The ADA follow an evidence based approach and they lay out their methodology very clearly at the start of the Standard of Care. Until the rules are changed those are the rules everyone is playing under whether people like it or not. Are they the best, cleverest, smartest, whatever, rules? Probably not, but the thing is they are the rules so that's where we are. An evidence based approach, now thats funny. The follow a political money driven approach.
Right now they have a factual mistake on page 80. Lets see how fast they fix it.
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Post by lennymnkd on Oct 6, 2018 12:36:01 GMT -5
Close enough for government work 🤨
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Post by agedhippie on Oct 6, 2018 16:05:58 GMT -5
The ADA follow an evidence based approach and they lay out their methodology very clearly at the start of the Standard of Care. Until the rules are changed those are the rules everyone is playing under whether people like it or not. Are they the best, cleverest, smartest, whatever, rules? Probably not, but the thing is they are the rules so that's where we are. The SoC is bias and contains inaccurate and minimal information pertaining to Afrezza. Then Mannkind needs to put out more good large scales trials and there will be more information. That's the way this works and they are very clear on that. |
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Post by agedhippie on Oct 6, 2018 16:24:50 GMT -5
The ADA follow an evidence based approach and they lay out their methodology very clearly at the start of the Standard of Care. Until the rules are changed those are the rules everyone is playing under whether people like it or not. Are they the best, cleverest, smartest, whatever, rules? Probably not, but the thing is they are the rules so that's where we are. An evidence based approach, now thats funny. The follow a political money driven approach.
Right now they have a factual mistake on page 80. Lets see how fast they fix it.
The Standard of Care is defensible because for each statement made they can point to high quality trial data supporting it. However the money comment is not unreasonable, but in my view more because of the high cost of assembling the trial data necessary to present the evidence. This is a big problem for small pharmas lacking the cash to fund the necessary research and hence a bias. I think they will start referring to Afrezza as inhaled rapid action, and the RAAs as injectable rapid action. If they create an ultra rapid category I would expect them to use the same split. |
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Post by mango on Oct 6, 2018 17:30:29 GMT -5
The SoC is bias and contains inaccurate and minimal information pertaining to Afrezza. Then Mannkind needs to put out more good large scales trials and there will be more information. That's the way this works and they are very clear on that. What sort of trials? |
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Post by sayhey24 on Oct 6, 2018 17:43:57 GMT -5
The analogs already have their class - rapid acting analogs. I see no change to this class. Page 80 is factually wrong and a new class needs to be established, asap. Calling afrezza in the current standard an analog is a disgrace and the ADA should be ashamed of themselves.
Compared to the RAA's including FIASP, afrezza is significantly faster both in and out. It is near natural. Mike like's ultra. Whatever they call it, if afrezza is the only insulin in this new class the BP's are not going to be happy if they need to show non-inferiority in speed to be included in the category. I see no reason to distinguish inhaled versus injected for speed. This category is about speed not method of application.
Additionally, the standard currently says "inhaled insulin". It should say Technosphere Insulin in the new category. The last I checked there are 2 approved inhaled insulins and Exubera is significantly slower than afrezza - Technosphere Insulin
As far as the current standard for T2s its a treat to failure standard. Prior to afrezza this approach was defensible but it is no longer. A standard which is a treat for success standard is now warranted. Dr. Kendall has pledged to fix it and I think he will.
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Post by mango on Oct 6, 2018 18:16:32 GMT -5
The ADA follow an evidence based approach and they lay out their methodology very clearly at the start of the Standard of Care. Until the rules are changed those are the rules everyone is playing under whether people like it or not. Are they the best, cleverest, smartest, whatever, rules? Probably not, but the thing is they are the rules so that's where we are. An evidence based approach, now thats funny. The follow a political money driven approach.
Right now they have a factual mistake on page 80. Lets see how fast they fix it.
And in Table 8.4 on page 82 |
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Post by mango on Oct 6, 2018 19:33:38 GMT -5
The analogs already have their class - rapid acting analogs. I see no change to this class. Page 80 is factually wrong and a new class needs to be established, asap. Calling afrezza in the current standard an analog is a disgrace and the ADA should be ashamed of themselves. Compared to the RAA's including FIASP, afrezza is significantly faster both in and out. It is near natural. Mike like's ultra. Whatever they call it, if afrezza is the only insulin in this new class the BP's are not going to be happy if they need to show non-inferiority in speed to be included in the category. I see no reason to distinguish inhaled versus injected for speed. This category is about speed not method of application. Additionally, the standard currently says "inhaled insulin". It should say Technosphere Insulin in the new category. The last I checked there are 2 approved inhaled insulins and Exubera is significantly slower than afrezza - Technosphere Insulin As far as the current standard for T2s its a treat to failure standard. Prior to afrezza this approach was defensible but it is no longer. A standard which is a treat for success standard is now warranted. Dr. Kendall has pledged to fix it and I think he will. Lilly is for sure aiming for the ultra classification with their "ultra-rapid insulin lispro." The slow, erratic absorption of the RAA insulin from subcutaneous tissue will always be a limiting factor in mimicking physiologic insulin. |
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Post by agedhippie on Oct 6, 2018 21:13:47 GMT -5
Then Mannkind needs to put out more good large scales trials and there will be more information. That's the way this works and they are very clear on that. What sort of trials? As I have been saying for a couple of years now - a superiority trial. I would suggest killing two birds with one stone and rerun Affinity-1 with the dosing from STAT. As for sizing and duration I would look at the trials that the ADA considers category A or B and aim for a comparable scale. Designing suitable trials is Dr Kendall's area of expertise but the blocker up until now has been cash. Hopefully they will spend part of the new money on trials. |
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Post by mango on Oct 6, 2018 21:34:43 GMT -5
As I have been saying for a couple of years now - a superiority trial. I would suggest killing two birds with one stone and rerun Affinity-1 with the dosing from STAT. As for sizing and duration I would look at the trials that the ADA considers category A or B and aim for a comparable scale. Designing suitable trials is Dr Kendall's area of expertise but the blocker up until now has been cash. Hopefully they will spend part of the new money on trials. The reproducible and verifiable results, in both real-life and controlled settings, consistently without fail, demonstrates Afrezza's superiority. We still have clinical trials data that remains, of which two of them, T2D trials, we should be hearing about soon. The elephant in the room is the ADA's illogical thinking. Their SoC lacks basic common sense and has resulted in a massive failure in the fight against the global diabetes threat. PWD do not have time to wait on the ADA to get their shit together. As far as I am concerned, the current state of affairs with diabetes is so overwhelming that we do not have the time to waste conducting more randomized controlled trials when we already have the information right in front of us. We have a rock solid foundation of scientific evidence and now can employ real-life, real-time data gathering devices that can render us wealths of meaningful and useful information that RCTs cannot, right this very moment. The ADA's irresponsibility and the SoC's dangerous pill mill and barbaric treatments won't hinder MannKind from accomplishing the mission. |
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Post by stevil on Oct 6, 2018 22:28:01 GMT -5
As I have been saying for a couple of years now - a superiority trial. I would suggest killing two birds with one stone and rerun Affinity-1 with the dosing from STAT. As for sizing and duration I would look at the trials that the ADA considers category A or B and aim for a comparable scale. Designing suitable trials is Dr Kendall's area of expertise but the blocker up until now has been cash. Hopefully they will spend part of the new money on trials. The reproducible and verifiable results, in both real-life and controlled settings, consistently without fail, demonstrates Afrezza's superiority. We still have clinical trials data that remains, of which two of them, T2D trials, we should be hearing about soon. The elephant in the room is the ADA's illogical thinking. Their SoC lacks basic common sense and has resulted in a massive failure in the fight against the global diabetes threat. PWD do not have time to wait on the ADA to get their shit together. As far as I am concerned, the current state of affairs with diabetes is so overwhelming that we do not have the time to waste conducting more randomized controlled trials when we already have the information right in front of us. We have a rock solid foundation of scientific evidence and now can employ real-life, real-time data gathering devices that can render us wealths of meaningful and useful information that RCTs cannot, right this very moment. The ADA's irresponsibility and the SoC's dangerous pill mill and barbaric treatments won't hinder MannKind from accomplishing the mission. Whether you keep complaining or not, it will make no difference. People are answering your questions and you keep arguing about the answers. There is a protocol in place that they follow. It is consistent, methodical, and evidence-based using randomized, controlled trials. I feel like it would be very helpful for you to do some research on how clinical trials are run. To learn the statistics behind them, the protocol that is used. It just seems like there's an awful lot of wasted energy on this site with people huffing and puffing about things that are never going to change. It is the way it is. And it is the way it is for good reason. It's not necessarily something that needs to change. The practice of medicine should always be conservative for indolent disease processes. There's no reason to be unnecessarily aggressive with a disease that will take decades to kill someone. The ADA has a huge responsibility because thousands of doctors will follow their guidelines. They're not going to rush into anything. They will require piles of evidence, outside of pictures on the internet, to support their recommendations. It cannot be known if the people on the internet who post positive results are randomized. They very well could be a self-selected group based on their success. Maybe they are more diligent with dosages. Maybe they are better educated. Maybe they have better access to healthcare. Maybe they all can afford Dexcom/CGM's, etc, etc, etc. The ADA has to be careful with blanket recommendations because Afrezza may not be best for those who aren't educated, don't have access to healthcare, can't afford CGM's. It's why completely randomized trials are necessary. If there are positive results across the board, the drug is beneficial and can be recommended. There are way more variables than people on this board know. Whenever people groan about how stupid doctors are, they should consider that very few things in the practice of medicine are simple. It wouldn't take 4 years of undergrad plus 4 years of medical school plus residency if medicine was as simple as people make it out to be. It seems like it's way easier to believe that MNKD needs to provide good data that Afrezza is safer and more effective than its competitors than it is that doctors are dumb or the ADA is full of corrupt hooligans. Let's wait until the data appears- again, outside of a couple internet pictures of online users- and if the data gets ignored, I'll jump on that bandwagon with you. Until then, complaining will only add to your disappointment. Because again, it's not going to change. You're hitting your head against a brick wall my friend. |
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Post by mango on Oct 6, 2018 23:11:29 GMT -5
The reproducible and verifiable results, in both real-life and controlled settings, consistently without fail, demonstrates Afrezza's superiority. We still have clinical trials data that remains, of which two of them, T2D trials, we should be hearing about soon. The elephant in the room is the ADA's illogical thinking. Their SoC lacks basic common sense and has resulted in a massive failure in the fight against the global diabetes threat. PWD do not have time to wait on the ADA to get their shit together. As far as I am concerned, the current state of affairs with diabetes is so overwhelming that we do not have the time to waste conducting more randomized controlled trials when we already have the information right in front of us. We have a rock solid foundation of scientific evidence and now can employ real-life, real-time data gathering devices that can render us wealths of meaningful and useful information that RCTs cannot, right this very moment. The ADA's irresponsibility and the SoC's dangerous pill mill and barbaric treatments won't hinder MannKind from accomplishing the mission. Whether you keep complaining or not, it will make no difference. There is a protocol in place that they follow. It is consistent, methodical, and evidence based using randomized, controlled trials. I feel like it would be very helpful for you to do some research on how clinical trials are run. To learn the statistics behind them, the protocol that is used. It just seems like there's an awful lot of wasted energy on this site with people huffing and puffing about things that are never going to change. It is the way it is. And it is the way it is for good reason. It's not necessarily something that needs to change. The practice of medicine should always be conservative for indolent disease processes. There's no reason to be unnecessarily aggressive with a disease that will take decades to kill someone. The ADA has a huge responsibility because thousands of doctors will follow their guidelines. They're not going to rush into anything. They will require piles of evidence, outside of pictures on the internet, to support their recommendations. It cannot be known if the people on the internet who post positive results are randomized. They very well could be a self-selected group based on their success. Maybe they are more diligent with dosages. Maybe they are better educated. Maybe they have better access to healthcare. Maybe they all can afford Dexcom/CGM's, etc, etc, etc. The ADA has to be careful with blanket recommendations because Afrezza may not be best for those who aren't educated, don't have access to healthcare, can't afford CGM's. It's why completely randomized trials are necessary. If there are positive results across the board, the drug is beneficial and can be recommended. There are way more variables than people on this board know. Stevil, you are making no sense. In T2D there is a loss of the first-phase insulin response and people gradually develop worsening post-prandial hyperglycemia. Coupled with the loss of the FPIR during the early stages of the disease, people do not shut-off glucose release after a meal, so we see increased demands put on the pancreas as the disease progresses, facilitating beta cell dysfunction and death, diminished insulin production and worsening control of blood sugar. This can eventually develop into an insulin deficit like that of a Type 1. Metformin, SGLT2-inhibitors, GLP1, etc... will not and cannot replace the FPIR, thus they cannot restore post-prandial glucose homeostasis, which should be the goal and intent of treating this disease in the first place. Furthermore, ADA recommends basal insulin therapy for T2D (and before prandial insulin therapy). That is medically incorrect. Treatment of the patient with diabetes is really simple stevil: restoring glucose homeostasis by matching physiologic insulin secretion. Afrezza does just that. The pills do nothing but put a bandaid on the disease until it gets worse, and it always gets worse. Subcutaneous prandial insulin formulation absorption is erratic and much too slow, and to quote the MannKind CMO, "they are barbaric." These therapies have no logical place in the treatment of T2D, and rightfully so considering there is only one that is medically correct, and Afrezza fits the bill. |
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Post by uvula on Oct 7, 2018 2:14:05 GMT -5
Mango, no one is disagreeing with your hypothesis. But it needs to be proven.
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Post by sayhey24 on Oct 7, 2018 8:41:10 GMT -5
uvula - I don't think what Mango is saying is hypothesis. Its the way it is. ALL PWDs first lose first phase insulin release. The 118 study demonstrates afrezza blocks the alpha cells.
What is it you think is hypothesis?
None of the current orals can shut off liver sugar production and none of the subq insulins are fast enough. In fact their being out of sync leads to the hypos.
Also ALL the orals rely on the damaged pancreas to produce enough insulin when the pancreas needs time to rest and try to heal.
Our entire approach in treating T2's today is a treat to fail model. Everything we are doing is wrong. As soon as we have a pre-diabetic in addition to the walk and diet they should be taking the afrezza. If Joslin is correct and diabetes is a viral infection the pancreas needs to rest and give the immune system a chance to fight it off and allow beta cell regeneration.
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