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Post by uvula on Oct 7, 2018 9:01:39 GMT -5
You folks sound like the doctors selling expensive stem cell treatments. They claim it works because they have a handful of success stories but they refuse to do clinical trials so the medical community does not consider this to be a legitimate treatment.
The only real option is spending millions on clinical trials but it will be worth billions in the long run.
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Post by lennymnkd on Oct 7, 2018 10:07:46 GMT -5
Or run a massive amount of commercial ads.
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Post by uvula on Oct 7, 2018 10:28:12 GMT -5
Or run a massive amount of commercial ads. Not really. Running massive amounts of commercials works for the stem cell folks because the patients are mostly paying cash. For Afrezza running lots of commercials will help with patient awareness but will do nothing for insurance coverage.
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Post by lennymnkd on Oct 7, 2018 10:40:00 GMT -5
Mike seems to be pretty comfortable in the progress he seems to be making in healthcare coverage , ever time he speaks to us , he sounds encouraged/ could this work without SOC ?
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Post by letitride on Oct 7, 2018 13:56:36 GMT -5
Maybe it isnt the SOC we should be looking for but TBC = The Best Care for people that want to live like people not like calculators or machines. The extreme afrezza challenge comes to mind. What the hell is so extreme about a coke and an ice cream unless your on the current SOC.
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Post by lennymnkd on Oct 7, 2018 14:50:06 GMT -5
Went to a wedding last night , couple sitting next to me and my wife we’re really nice , hit it off with the guy from the start ( professional finance guy ) talked about everything . Around dessert he wipes out metformin ... I give it the old TYPE 2 ? He says yes / I go into my have you ever heard of AFREZZA SPEAL 😀 he says yes and I go on to explain / well it was like I was talking to a wall ... had to lay off ...can’t be easy for all involved from our sales reps to mike himself ... people get set in there ways / hope some very creative advertising can do the trick,,,, !
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Post by mango on Oct 7, 2018 15:25:19 GMT -5
MannKind has completed over 60 studies on Afrezza in over 5,000 participants. We should have all the necessary information once the ongoing trial studies are completed. I don't think it is necessary to conduct any additional RCTs, but it would be wise to continue with real-world data via CGMs and digital health platforms and conduct additional real-life studies, like with STAT.
RCTs and real-life studies have opposite strengths in terms of validity and should be used together. Traditional clinical trials are designed to control variability through use of comprehensive eligibility criteria, protocols, monitoring and data auditing. These trials are useful for establishing a baseline, but because of practical challenges they have a narrow scope. RCTs provide "efficacy" information under conditions that are opposite of real life. Applicability is restricted to ideal conditions which limits knowledge of what will happen in the real world. RCTs use selection bias, monitoring bias and strict patient management to help favorably produce results and steer outcomes, and their strict design does not allow for the full detection of side-effects and adverse events, thus does not reflect real-life. For these reasons it would be logical to compliment RCTs with real-life studies, particularly for confirming results produced in RCTs and for safety surveillance.
The hypo data from the real-life STAT study provided confirmation for the hypo data from the Affinity 1 study.
STAT also demonstrated that Afrezza achieves significantly better post-prandial glucose control and PPGE. One can use logic here and conclude that these results would apply to all RAAs.
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Post by mango on Oct 7, 2018 18:50:44 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. 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. Understanding does not require a medical degree. Whether you want to accept it or not the fact remains that the ADA's SoC in T2D has been a proven failure because it recommends a list of treatments that are medically incorrect, and saves the correct one for last. By the time the medically correct treatment is recommended there has been significant disease progression and irreversible short and long-term damage. This irresponsible and ignorant thinking causes needless suffering to PWD. I feel like it would be very helpful for you to use some logical thinking.
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Post by agedhippie on Oct 7, 2018 20:47:31 GMT -5
Understanding does not require a medical degree. Whether you want to accept it or not the fact remains that the ADA's SoC in T2D has been a proven failure because it recommends a list of treatments that are medically incorrect, and saves the correct one for last. By the time the medically correct treatment is recommended there has been significant disease progression and irreversible short and long-term damage. This irresponsible and ignorant thinking causes needless suffering to PWD. I feel like it would be very helpful for you to use some logical thinking. None of that is relevant. The ADA writes the Standard of Care according to their published criteria and that is what the vast majority of the medical profession follows. In all seriousness if you think they are wrong publish your own SoC and see what traction you can get with the medical profession. This already happens today with the AACE/ACE, the ADA do not have a monopoly.
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Post by brotherm1 on Oct 7, 2018 21:26:15 GMT -5
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Post by mango on Oct 8, 2018 0:12:16 GMT -5
Understanding does not require a medical degree. Whether you want to accept it or not the fact remains that the ADA's SoC in T2D has been a proven failure because it recommends a list of treatments that are medically incorrect, and saves the correct one for last. By the time the medically correct treatment is recommended there has been significant disease progression and irreversible short and long-term damage. This irresponsible and ignorant thinking causes needless suffering to PWD. I feel like it would be very helpful for you to use some logical thinking. None of that is relevant. The ADA writes the Standard of Care according to their published criteria and that is what the vast majority of the medical profession follows. In all seriousness if you think they are wrong publish your own SoC and see what traction you can get with the medical profession. This already happens today with the AACE/ACE, the ADA do not have a monopoly. It's 100% relevant, but what is irrelevant is any protocol and published criteria ADA uses to write the SoC because it's medically incorrect and consistently fails. These are the facts. SoC is an opinion. Maybe one day soon we can lay this to rest when we compare the outcomes of the Vdex Protocol to ADA's SoC. Afrezza First, Afrezza Instead, Afrezza Alwaysstatic1.squarespace.com/static/5a37ff648fd4d234be3cea06/t/5b5002fe6d2a73516218aea6/1531970306245/vdex-whitepaper-071818.pdf
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Post by sayhey24 on Oct 8, 2018 5:28:01 GMT -5
You folks sound like the doctors selling expensive stem cell treatments. They claim it works because they have a handful of success stories but they refuse to do clinical trials so the medical community does not consider this to be a legitimate treatment. The only real option is spending millions on clinical trials but it will be worth billions in the long run. uvula - There have already been a "zillion" studies done on early insulin intervention. The one thing all these studies have in common is insulin always works. Comparing insulin to stem cell therapy is way off the mark.
However, none of these studies have been done with a "Superior" insulin. Its possible but I would be shocked if the results with afrezza are worse. My guess is they would be significantly better and the clinical results are bearing this out.
Moreover, stopping the post meal spike has huge heart benefits. Thats the study I would like to see but not needed to gets standards updates with all the other study data.
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Post by lennymnkd on Oct 8, 2018 7:46:47 GMT -5
The more I see it ,I don’t think most type twos (80% of the market ) take their illness serious enough / very matter of fact ...doctors become complacent / more has to be done to educate the patient population .almost scare them into what could become the severity of it. HAVE TO HURT THEM TO HELP THEM ! Then we will gain real traction
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Post by mango on Oct 8, 2018 7:51:53 GMT -5
To paraphrase Dr. Ralph DeFronzo: Proper disease management involves identifying its etiology and correcting the underlying pathophysiological disturbance. The evidence tells us that beta cell failure is the primary underlying abnormality responsible for the development of T2D, and by the time a diagnosis is made the person will have lost about 80% of their beta-cell function and nearly 50% beta-cell volume. In the ADA's SoC for T2D, recommendations are deployed involving numerous pharmacological interventions that simply target hyperglycemia, while not even addressing the underlying defect, which results in the inability to maintain tight blood glucose control, preserve and/or prevent further beta-cell dysfunction, and sustain a reduction in HbA1c. Unsuprisingly, ADA approaches therapeutic intervention for people with T2D using recommendations with a focus on lowering plasma glucose concentration instead of correcting an underlying abnormality that is causing the persistent and progressive hyperglycemia. Numerous studies, including a 15-year-long study completed nearly two decades ago, shows sulfonylurea provides no beta-cell protection and is associated with worsening glycemic control and progressively higher A1C. The same 15-year-long study also demonstrated Metformin's glycemic control progressively diminished following an initial A1C decline, and has no protective benefit on beta cell function. Thus, these two ADA recommended medications in the treatment of T2D failed to prevent beta-cell dysfunction, provide adequate glycemic control, or correct the underlying pathogenic defect—all of which was further evidenced and observed in the study when an additional pharmacologic agent had to added to the treatment regimen of 50% or so of the participants in the trial after the metformin/sulfonylurea combo failed. Further still, numerous additional clinical studies support these findings. Together, they conclusively demonatrate that sulfonylureas offer no therapeutic benefit and their use results in progressive beta-cell dysfunction with worsening glycemic control. These data demonstrates Metformin and sulfonylurea, alone or in combination, offers no beta cell protection and results in worsening glycemic control with a corresponding rise in A1C values—indicating progressive decline in beta cell function. The currently recommended pharmacological treatment options in the Standard of Care for T2D still includes Metformin as the first-line therapy and also still includes the use of Sulfonylureas. ADA appears to have neglected the overwhelming body of evidence-based medicine that conclusively demonstrates Metformin and Sulfonylureas have no protective benefits on beta cell function, and do not provide adequate glycemic control. This means ADA's SoC does not practice evidenced-based medicine. Instead, it ignores evidence-based medicine and relies on author opinions whose contents may or may not have been financially and politically motivated. I must conclude that ADA's behavior was described and forewarned about in general by Elizabeth Blackwell back in the mid 1800's. She was America's first female physician, one of the most brilliant as well. Lastly, the preposterous assertion made by you, stevil : There's no reason to be unnecessarily aggressive with a disease that will take decades to kill someone. Most certaintly basks in the bliss of ignorance.Â
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Post by Deleted on Oct 8, 2018 8:03:01 GMT -5
To paraphrase Dr. Ralph DeFronzo: Proper disease management involves identifying its etiology and correcting the underlying pathophysiological disturbance. The evidence tells us that beta cell failure is the primary underlying abnormality responsible for the development of T2D, and by the time a diagnosis is made the person will have lost about 80% of their beta-cell function and nearly 50% beta-cell volume. In the ADA's SoC for T2D, recommendations are deployed involving numerous pharmacological interventions that simply target hyperglycemia, while not even addressing the underlying defect, which results in the inability to maintain tight blood glucose control, preserve and/or prevent further beta-cell dysfunction, and sustain a reduction in HbA1c. Unsuprisingly, ADA approaches therapeutic intervention for people with T2D using recommendations with a focus on lowering plasma glucose concentration instead of correcting an underlying abnormality that is causing the persistent and progressive hyperglycemia. Numerous studies, including a 15-year-long study completed nearly two decades ago, shows sulfonylurea provides no beta-cell protection and is associated with worsening glycemic control and progressively higher A1C. The same 15-year-long study also demonstrated Metformin's glycemic control progressively diminished following an initial A1C decline, and has no protective benefit on beta cell function. Thus, these two ADA recommended medications in the treatment of T2D failed to prevent beta-cell dysfunction, provide adequate glycemic control, or correct the underlying pathogenic defect—all of which was further evidenced and observed in the study when an additional pharmacologic agent had to added to the treatment regimen of 50% or so of the participants in the trial after the metform/sulfonylurea combo failed. Further still, numerous additional clinical studies support these findings on sulfonylureas. Together, they conclusively demonatrate that sulfonylureas offered no therapeutic benefit and their use results in progressive beta-cell dysfunction with worsening glycemic control. These data demonstrates Metformin and sulfonylurea, alone or in combination, offers no beta cell protection and results in worsening glycemic control with a corresponding rise in A1C values—indicating progressive decline in beta cell function. The currently recommended pharmacological treatment options in the Standard of Care for T2D still includes Metformin as the first-line therapy and also still includes the use of Sulfonylureas. ADA appears to have neglected the overwhelming body of evidence-based medicine that conclusively demonstrates Metformin and Sulfonylureas have no protective benefits on beta cell function, and do not provide adequate glycemic control. This means ADA's SoC does not practice evidenced-based medicine. Instead, it ignores evidence-based medicine and relies on author opinions whose contents may or may not be financially and politically motivated. Lastly, the preposterous assertion made by you, stevil : There's no reason to be unnecessarily aggressive with a disease that will take decades to kill someone. Most certaintly basks in the bliss of ignorance.
Furthermore, diabetes causes the most long term damage to a patient in the early stages of the disease as that is when the glucose volatility causes the greatest shocks to the body. With time, the peaks and valleys still cause harm / long term damage but the body gets "used" to them on some level. Even before the DCCT study, a very large institution which you all know did research and found that very tight control of BG levels in general reduced LT health complications and with tight control coming to the patient earlier on in their diabetes, the better the LT outcomes.
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