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Post by mango on Feb 18, 2020 13:29:48 GMT -5
mango, I suspect (with no actual proof) that all of those horrific drugs you mentioned have undergone large expensive clinical trials. The ADA follows the FDA. ADA uses Consensus (opinion) and has a hierarchal donor system for their Pay-to-Play members. It's on their website. They also have to include financial disclosures in their SoC and related Consensus Statements made by them and also by AACE and ACE. No matter how it is spun, the SoC has been, time and time again, a proven treat to failure. People don't get better on the orals, they always get worse. People don't do better on the barbaric mealtime insulins. Afrezza is the safest and most effective mealtime option there is. People that skate around the whole "need more and larger clinical trials" excuse must have forgotten that Metformin was added as the first line treatment of choice with dismal and unimpressive evidence. Since that time, Metformin has proven to be a failure. |
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Post by agedhippie on Feb 18, 2020 13:32:26 GMT -5
We all know ADA is a pay-to-play scheme. ADA is really more like a slush fund than anything else. Data? Clinical trials? Evidence? Just look at the dismal and unimpressive evidence ADA uses to justify its antiquated and barbaric SoC. For *uck sake just look at what the first line therapy is for T2D and the evidence (or lack thereof) supporting it, especially the pathetic evidence used for approving it here in the USA and making it the standard of care. SGLT2 inhibitors, GLP1s, Metformin—all endocrine disruptors—with horrific safety profiles and terrible side effects. People are losing their arms and legs and toes, with this chit. Then there is the antiquated and barbaric mealtime insulin options...appears ADA doesn't know WTF they are doing with their PROVEN Treat to Failure SoC. /rant over If you want to be in the game then you know the rules - produce evidence or go home and the ADA is very clear on what that evidence has to look like. Just say all the options are horrible and then not doing anything about it will get you exactly no where. First line therapy for T2D is metformin and there is ton of trial data that says taking metformin will reduce your A1c. Will it reduce it forever? Sometimes, but often not. Are there side effects for SGLT2, GLP-1, etc? Absolutely, but the again there is a ton of trial data that says the benefits outweigh the side effects. You can rant, but the medical world doesn't care - it's fact based and in that world the facts are the trial data. No trial data - no facts, it's really simple to play. |
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Post by mango on Feb 18, 2020 13:46:21 GMT -5
We all know ADA is a pay-to-play scheme. ADA is really more like a slush fund than anything else. Data? Clinical trials? Evidence? Just look at the dismal and unimpressive evidence ADA uses to justify its antiquated and barbaric SoC. For *uck sake just look at what the first line therapy is for T2D and the evidence (or lack thereof) supporting it, especially the pathetic evidence used for approving it here in the USA and making it the standard of care. SGLT2 inhibitors, GLP1s, Metformin—all endocrine disruptors—with horrific safety profiles and terrible side effects. People are losing their arms and legs and toes, with this chit. Then there is the antiquated and barbaric mealtime insulin options...appears ADA doesn't know WTF they are doing with their PROVEN Treat to Failure SoC. /rant over If you want to be in the game then you know the rules - produce evidence or go home and the ADA is very clear on what that evidence has to look like. Just say all the options are horrible and then not doing anything about it will get you exactly no where. First line therapy for T2D is metformin and there is ton of trial data that says taking metformin will reduce your A1c. Will it reduce it forever? Sometimes, but often not. Are there side effects for SGLT2, GLP-1, etc? Absolutely, but the again there is a ton of trial data that says the benefits outweigh the side effects. You can rant, but the medical world doesn't care - it's fact based and in that world the facts are the trial data. No trial data - no facts, it's really simple to play. Expected response. What your response does not veil is the simple fact that ADA's SoC is a proven failure. That is an objective fact and reality. You can say you don't agree with that all day long, but it will still be a fact until ADA changes from an opinionated (consensus), Pay-to-Play platform to a scientific and moral platform. 👍 |
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Post by goyocafe on Feb 18, 2020 13:56:21 GMT -5
I'm not blaming FDA.. it's more just a matter of fact. The restrictions make it difficult to market Afrezza... I completely agree that management needed to spend what money we had wisely.. I think the FDA is complicit in both their oversight and ignorance. That refused a protocol that would have potentially demonstrated Afrezza superiority because it didn’t fit established use of insulin and therefore forced MNKD into adjusting the trial protocols to please the FDA. This set the trial up for near failure to even meet non-inferiority labeling. Recall the ADCOM when the FDA was chastised for their imposing restrictions on MNKD and the trial design and the acknowledgement by one doctor stating that had the comparator arm of the trial been allowed to treat as MNKD wanted, it could have killed the patients. |
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Post by barnstormer on Feb 18, 2020 14:01:16 GMT -5
All good points above. So where is Kendall in all of this? He is Mike's Golden Boy from the ADA? Perhaps he really wasn't a player there and he doesn't seem to be one here. His impact on the veins of gold he was mining from the MNKD vaults must have experienced a cave in. Little has come out in the last two years since his boasts made at the ASM. He has few if any shares. Looks like a bust to me.
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Post by uvula on Feb 18, 2020 14:13:45 GMT -5
I'm not blaming FDA.. it's more just a matter of fact. The restrictions make it difficult to market Afrezza... I completely agree that management needed to spend what money we had wisely.. I think the FDA is complicit in both their oversight and ignorance. That refused a protocol that would have potentially demonstrated Afrezza superiority because it didn’t fit established use of insulin and therefore forced MNKD into adjusting the trial protocols to please the FDA. This set the trial up for near failure to even meet non-inferiority labeling. Recall the ADCOM when the FDA was chastised for their imposing restrictions on MNKD and the trial design and the acknowledgement by one doctor stating that had the comparator arm of the trial been allowed to treat as MNKD wanted, it could have killed the patients. I forgot about how the FDA mucked up the original clinical trial so I guess it is fair to say that the FDA is partly to blame for the current situation. The question is what we do about it now. No one is saying the current ADA SOC is good. We just disagree on how we can get it changed. One thing that won't work is complaining about the ADA. |
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Post by mango on Feb 18, 2020 14:15:50 GMT -5
ADA's Treat to Failure: Metformin Triple Therapy  |
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Post by agedhippie on Feb 18, 2020 14:23:36 GMT -5
If you want to be in the game then you know the rules - produce evidence or go home and the ADA is very clear on what that evidence has to look like. Just say all the options are horrible and then not doing anything about it will get you exactly no where. First line therapy for T2D is metformin and there is ton of trial data that says taking metformin will reduce your A1c. Will it reduce it forever? Sometimes, but often not. Are there side effects for SGLT2, GLP-1, etc? Absolutely, but the again there is a ton of trial data that says the benefits outweigh the side effects. You can rant, but the medical world doesn't care - it's fact based and in that world the facts are the trial data. No trial data - no facts, it's really simple to play. Expected response. What your response does not veil is the simple fact that ADA's SoC is a proven failure. That is an objective fact and reality. You can say you don't agree with that all day long, but it will still be a fact until ADA changes from an opinionated (consensus), Pay-to-Play platform to a scientific and moral platform. 👍 I am not arguing that I like the SoC! My point it that's complaining about the SoC is like complaining about the weather - it doesn't change the weather so I dress accordingly. |
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Post by sweedee79 on Feb 18, 2020 14:26:55 GMT -5
My dad had been on Metformin 1000mg daily until recently being diagnosed with kidney failure.. First thing the doc did was take him off of the Metformin which he had been on for over 20 years.
Metformin has a black box warning due to the danger of lactic acidosis which can be life threatening.
Metformin has many adverse side effects.. and a black box warning yet it is one of the most prescribed drugs for diabetes.. it sells because it's cheap not because it's the best treatment.. and probably recommended by the ADA.. and our SOC..
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Post by agedhippie on Feb 18, 2020 14:37:34 GMT -5
All good points above. So where is Kendall in all of this? He is Mike's Golden Boy from the ADA? Perhaps he really wasn't a player there and he doesn't seem to be one here. His impact on the veins of gold he was mining from the MNKD vaults must have experienced a cave in. Little has come out in the last two years since his boasts made at the ASM. He has few if any shares. Looks like a bust to me. The day Kendall walked out the door to take the job at Lilly the non-profit world will view him as having changed sides. His job became to be an advocate for his first employer and diabetics second. At this point he is nearly ten years removed from the ADA so I think he is going to need to rely on his own abilities rather than the old boys network. Looking at his record he should be able to do this in his own right. |
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Post by mango on Feb 18, 2020 15:08:00 GMT -5
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Post by ktim on Feb 18, 2020 15:25:47 GMT -5
mango, I suspect (with no actual proof) that all of those horrific drugs you mentioned have undergone large expensive clinical trials. The ADA follows the FDA. ADA uses Consensus (opinion) and has a hierarchal donor system for their Pay-to-Play members. It's on their website. They also have to include financial disclosures in their SoC and related Consensus Statements made by them and also by AACE and ACE. No matter how it is spun, the SoC has been, time and time again, a proven treat to failure. People don't get better on the orals, they always get worse. People don't do better on the barbaric mealtime insulins. Afrezza is the safest and most effective mealtime option there is. People that skate around the whole "need more and larger clinical trials" excuse must have forgotten that Metformin was added as the first line treatment of choice with dismal and unimpressive evidence. Since that time, Metformin has proven to be a failure. All the trials that have produced promising data on early intensive insulin intervention in T2, potentially inducing remission, have been using those "barbaric" mealtime insulins. And those "barbaric" insulins are producing some pretty impressive results in artificial pancreas systems. Though, I do believe too much time is wasted on oral anti-diabetic agents like metformin. But a significant driver there is cost. |
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Post by mango on Feb 18, 2020 15:28:47 GMT -5
ADA uses Consensus (opinion) and has a hierarchal donor system for their Pay-to-Play members. It's on their website. They also have to include financial disclosures in their SoC and related Consensus Statements made by them and also by AACE and ACE. No matter how it is spun, the SoC has been, time and time again, a proven treat to failure. People don't get better on the orals, they always get worse. People don't do better on the barbaric mealtime insulins. Afrezza is the safest and most effective mealtime option there is. People that skate around the whole "need more and larger clinical trials" excuse must have forgotten that Metformin was added as the first line treatment of choice with dismal and unimpressive evidence. Since that time, Metformin has proven to be a failure. All the trials that have produced promising data on early intensive insulin intervention in T2, potentially inducing remission, have been using those "barbaric" mealtime insulins. And those "barbaric" insulins are producing some pretty impressive results in artificial pancreas systems. Though, I do believe too much time is wasted on oral anti-diabetic agents like metformin. But a significant driver there is cost. Very true, but ADA does not advocate for that. ADA recommends using insulin last. RAAs do have erratic, slow absorption and are dangerous compared to Afrezza. Afrezza is also being used in the artificial pancreas. |
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Post by ktim on Feb 18, 2020 16:08:12 GMT -5
All the trials that have produced promising data on early intensive insulin intervention in T2, potentially inducing remission, have been using those "barbaric" mealtime insulins. And those "barbaric" insulins are producing some pretty impressive results in artificial pancreas systems. Though, I do believe too much time is wasted on oral anti-diabetic agents like metformin. But a significant driver there is cost. Very true, but ADA does not advocate for that. ADA recommends using insulin last. RAAs do have erratic, slow absorption and are dangerous compared to Afrezza. Afrezza is also being used in the artificial pancreas. Think the preposition you were looking for is "with". But that has only been for very limited trials, not the systems actually coming to market. Yet to see what Lily's new ultra-rapid will achieve in AP. I could easily see T1 dividing into two camps... those that like set and forget will use AP with liquid insulin and those that don't want an invasive device 24/7 will use Afrezza. Though MNKD needs to get the show on the road before T1 market is all settled into APs and good results. |
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Post by rfogel on Feb 18, 2020 16:22:19 GMT -5
I think the FDA is complicit in both their oversight and ignorance. That refused a protocol that would have potentially demonstrated Afrezza superiority because it didn’t fit established use of insulin and therefore forced MNKD into adjusting the trial protocols to please the FDA. This set the trial up for near failure to even meet non-inferiority labeling. Recall the ADCOM when the FDA was chastised for their imposing restrictions on MNKD and the trial design and the acknowledgement by one doctor stating that had the comparator arm of the trial been allowed to treat as MNKD wanted, it could have killed the patients. I forgot about how the FDA mucked up the original clinical trial so I guess it is fair to say that the FDA is partly to blame for the current situation. The question is what we do about it now. No one is saying the current ADA SOC is good. We just disagree on how we can get it changed. One thing that won't work is complaining about the ADA. Did the FDA design the trial? As I understand it, all they do is approve or disapprove a trial submitted to them by the pharma. Design of the trial was Mannkind's responsibility. |
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