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Post by stevil on Oct 8, 2018 9:08:39 GMT -5
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. Mango, You seem like a pretty intelligent person. I disagree that understanding does not require a medical degree, however. The human body is so complex and every system works with the other. While there isn't a human being alive that I've met that understands the whole human body, there comes a point where the more you learn the more you realize you don't know. At least the good doctors I've run into think that way... I've seen a lot of Mavericks that shoot from the hip do a lot of real harm to their patients because they made decisions that made sense at the time based on the evidence they had, but ended up being incorrect in the end. I realize this may be a bit brash, but I would encourage you to practice a little bit of humility. I assure you that the vast majority of doctors I have met are not stupid ( although some have been...) If there's something you don't understand or disagree with, it's good to question, but when it comes to the whole field of doctors behaving the same way, it's probably for good reason. I'm not saying you're wrong. I actually very strongly agree with what you're saying. I just don't have the same haste as you when it comes to implementing Afrezza as standard of care. I think it's certainly headed in that direction and if MNKD is sitting on convincing data that they need to publish it. It sounds as though they are... You need to understand that sometimes you don't know what you don't know (myself included) which is why medicine should be practiced so conservatively. It takes time and mistakes to test hypotheses out. There has been a lot of evidence to draw from, but we're still learning as we go.
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Post by uvula on Oct 8, 2018 9:19:08 GMT -5
Sayhey, in your reply to my comment you say "my guess is..." I think that was my point. Until you do clinical trials it is just a guess, and that isn't good enough to change the SOC.
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Post by stevil on Oct 8, 2018 9:21:51 GMT -5
I'll add that Afrezza is FDA approved and that if I could prescribe it today, I would in a heartbeat. There is a difference between being safe to use and being standard of care.
MNKD has presented enough evidence to prove it is safe. It has not yet, in my opinion, proven it should yet be standard of care. But as I said in my previous post, I believe it is heading there if it is what we think it is.
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Post by mango on Oct 8, 2018 9:23:07 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. Mango, You seem like a pretty intelligent person. I disagree that understanding does not require a medical degree, however. The human body is so complex and every system works with the other. While there isn't a human being alive that I've met that understands the whole human body, there comes a point where the more you learn the more you realize you don't know. At least the good doctors I've run into think that way... I've seen a lot of Mavericks that shoot from the hip do a lot of real harm to their patients because they made decisions that made sense at the time based on the evidence they had, but ended up being incorrect in the end. I realize this may be a bit brash, but I would encourage you to practice a little bit of humility. I assure you that the vast majority of doctors I have met are not stupid ( although some have been...) If there's something you don't understand or disagree with, it's good to question, but when it comes to the whole field of doctors behaving the same way, it's probably for good reason. I'm not saying you're wrong. I actually very strongly agree with what you're saying. I just don't have the same haste as you when it comes to implementing Afrezza as standard of care. I think it's certainly headed in that direction and if MNKD is sitting on convincing data that they need to publish it. It sounds as though they are... You need to understand that sometimes you don't know what you don't know (myself included) which is why medicine should be practiced so conservatively. It takes time and mistakes to test hypotheses out. There has been a lot of evidence to draw from, but we're still learning as we go. stevil, a degree does not equate to entitlement and it certaintly does not make one immune to ignorance. Feel free to point out where I wrote physicians are stupid (I already know it doesn't exist). We're all spinning through space on this planet together, and while I am on it I will view everyone equal, and I do not idolize or place on pedestals and I won't be deceived into believing a human should or could be superior to anyone else because of the letters behind his/her name. I know physicians are not stupid, but many are ignorant on certain things, just like I am ignorant about many things, and no one is immune to ignorance, even those with a medical degree.
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Post by Deleted on Oct 8, 2018 10:00:29 GMT -5
Dr. Bernard Fisher, MD almost had his life destroyed; professionally, psychologically and emotionally because his ideas at the time were considered to be crazy, out of line with the medical community's "standard of care" and just plain wrong. He was born 8-23-18 and is still alive today and its a good thing he has the grit of a boy from SW PA, steel & coal in case you are wondering. He is they guy who pushed hard that a lumpectomy produced clinical outcomes as good as a mastectomy in a much less invasive and painful manner. The entire medical community dismissed him and fortunately, he didn't dismiss himself.
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Post by stevil on Oct 8, 2018 10:07:20 GMT -5
Mango, You seem like a pretty intelligent person. I disagree that understanding does not require a medical degree, however. The human body is so complex and every system works with the other. While there isn't a human being alive that I've met that understands the whole human body, there comes a point where the more you learn the more you realize you don't know. At least the good doctors I've run into think that way... I've seen a lot of Mavericks that shoot from the hip do a lot of real harm to their patients because they made decisions that made sense at the time based on the evidence they had, but ended up being incorrect in the end. I realize this may be a bit brash, but I would encourage you to practice a little bit of humility. I assure you that the vast majority of doctors I have met are not stupid ( although some have been...) If there's something you don't understand or disagree with, it's good to question, but when it comes to the whole field of doctors behaving the same way, it's probably for good reason. I'm not saying you're wrong. I actually very strongly agree with what you're saying. I just don't have the same haste as you when it comes to implementing Afrezza as standard of care. I think it's certainly headed in that direction and if MNKD is sitting on convincing data that they need to publish it. It sounds as though they are... You need to understand that sometimes you don't know what you don't know (myself included) which is why medicine should be practiced so conservatively. It takes time and mistakes to test hypotheses out. There has been a lot of evidence to draw from, but we're still learning as we go. stevil, a degree does not equate to entitlement and it certaintly does not make one immune to ignorance. Feel free to point out where I wrote physicians are stupid (I already know it doesn't exist). We're all spinning through space on this planet together, and while I am on it I will view everyone equal, and I do not idolize or place on pedestals and I won't be deceived into believing a human should or could be superior to anyone else because of the letters behind his/her name. I know physicians are not stupid, but many are ignorant on certain things, just like I am ignorant about many things, and no one is immune to ignorance, even those with a medical degree. You did not use those exact words, but you have said things concerning the ADA and doctors in general that give that tone. I do not look down on you at all or think I am superior to you. I am actually quite impressed with the knowledge you have without a formal education. It's difficult to get to where you have on your own. However, the point I didn't fully elaborate on is that solving one problem sometimes only causes another in the human body. The idea is to provide the best answer for the entire body, not just one organ system. You can't just hone in on one issue. Treatment often has consequences because everything is so intricately connected. Again, I am not saying that you are wrong. I just think that you don't have enough knowledge and/or experience to understand why doctors are so conservative in their approach. I think you're seeing, but maybe not understanding, that things are heading in that direction. Time in range is coming to the forefront. Technology is being used to aid in better glucose control. The data is showing good results and is supporting the overall hypothesis that tighter glucose control is more beneficial to overall health. It may seem pedantic, but it's important to not skip any steps. It usually doesn't take any skill to notice a problem. The skill is proven in how one fixes the issue. If you're going to make the argument that Afrezza is different than other insulin, you have to be willing to then undergo the same arduous process that other different chemicals/hormones/whatevers go through. At the end of the day, Afrezza is a hormone and its effects are not localized. While there can be near certainty that it will be safe, it does not have the added benefit of the normal checks and balances of the body to control it. You're introducing a predetermined dose into the body and asking a dysfunctional metabolism to respond accordingly. It is not natural, no matter how "natural" Afrezza is. It is why so many doctors that have no experience prescribing it have had difficulty early on. It behaves differently than what they are used to. Again, if you can't trust the process and understand why it exists, I hope you can at least accept that it does and have more peace of mind. Hang in there. I haven't lost faith at all in the medical community. They will get there if given the time and opportunity.
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Post by mango on Oct 8, 2018 12:32:42 GMT -5
Dr. Bernard Fisher, MD almost had his life destroyed; professionally, psychologically and emotionally because his ideas at the time were considered to be crazy, out of line with the medical community's "standard of care" and just plain wrong. He was born 8-23-18 and is still alive today and its a good thing he has the grit of a boy from SW PA, steel & coal in case you are wondering. He is they guy who pushed hard that a lumpectomy produced clinical outcomes as good as a mastectomy in a much less invasive and painful manner. The entire medical community dismissed him and fortunately, he didn't dismiss himself. Thanks for sharing this, just read the wiki what an awesome story! Takes an open-minded person to make leaps in medical advancement, whereas closed-minded people prevent it. I'm guessing the ones that opposed his research findings did so because they had been indoctinated to believe that the surgeries they performed were the only truth and so the surgeons appear to have also adopted this 'consensus' way of thought, which again, has no place in science. Al Mann and Afrezza mirrors this dude's story to a T. The great thing is, we aren't defending in a theory, more like trying to convince ADA to adopt evidenced-based medicine and use the basic science knowledge they obtained in medical school. They are lost in a deep rabbit hole, not sure what they expect to find, but it will be nice to finally free up much wasted resources and money spent on bias research that maybe could actually be fucused on something else, like helping people with diabetes for a change. Remember there was opposition to basic hand hygiene in the US medical profession, and how it prevents the spread of infection. Elizabeth Blackwell and Florence Nighengale credited for that one. Blackwell was also the one that pioneered the 4-year medical education in a medical college she started, an idea later stolen by Abraham Flexner for his medical education reform. Men were very much intimidated by women during that time. [10] Additionally, his work “provid[ed] evidence that breast cancer can be both treated and prevented.” "He was the first scientist to reject the idea that cancer was “autonomous of its host,” and to argue that “solid tumors such as breast cancer are likely to be systemic at the time of diagnosis and represent potential metastases during the life of the host.”
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Post by tingtongtung on Oct 8, 2018 13:16:21 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. Mango, You seem like a pretty intelligent person. I disagree that understanding does not require a medical degree, however. The human body is so complex and every system works with the other. While there isn't a human being alive that I've met that understands the whole human body, there comes a point where the more you learn the more you realize you don't know. At least the good doctors I've run into think that way... I've seen a lot of Mavericks that shoot from the hip do a lot of real harm to their patients because they made decisions that made sense at the time based on the evidence they had, but ended up being incorrect in the end. I realize this may be a bit brash, but I would encourage you to practice a little bit of humility. I assure you that the vast majority of doctors I have met are not stupid ( although some have been...) If there's something you don't understand or disagree with, it's good to question, but when it comes to the whole field of doctors behaving the same way, it's probably for good reason. I'm not saying you're wrong. I actually very strongly agree with what you're saying. I just don't have the same haste as you when it comes to implementing Afrezza as standard of care. I think it's certainly headed in that direction and if MNKD is sitting on convincing data that they need to publish it. It sounds as though they are... You need to understand that sometimes you don't know what you don't know (myself included) which is why medicine should be practiced so conservatively. It takes time and mistakes to test hypotheses out. There has been a lot of evidence to draw from, but we're still learning as we go. stevil, I couldn't agree with you more on "... there comes a point where the more you learn the more you realize you don't know ...". I'm sure you know its "Dunning-Kruger effect". I feel this every single day, now that I'm no longer fresh out of grad school (where I thought I knew everything). I haven't followed this whole thread. You have very valid points of being conservative in the medical field. But, when a new change comes in, there is a lot of push back ( unintentional - not wanting to change the known and trusted status-quo, intentional - the corrupt lobby protecting their turf). Afrezza is stuck in the middle. I hope the momentum that is being built, carries it forward. mango: And, I didn't know you have no formal education.. You write a lot of technical stuff. I honestly thought you are a PhD. Smart guy! :-)
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Post by mango on Oct 8, 2018 14:53:30 GMT -5
Stevil and I have taken our conversation private. I was rude to stevil and I do apologize to him/her for my behavior. We have a misunderstanding, but I think it will work itself out and we will be able to have a smooth conversation together.
Edit: I don't mind the debates with aged as they have been ongoing for years now and can be educational for me and is nothing personal on my end towards aged, but I do apologize to you too aged if I offended you.
I'm not apologizing for what I have said about ADA just to be clear. I did publicly apologize to Dr. Kendall for grouping him with the Endo Consensus after he found his moral obligation and calling to help others. I am open to apologizing to everyone in the Endo Consensus that follows Dr. Kendall's lead.
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Post by mnholdem on Oct 8, 2018 16:37:46 GMT -5
I'll add that Afrezza is FDA approved and that if I could prescribe it today, I would in a heartbeat. There is a difference between being safe to use and being standard of care. MNKD has presented enough evidence to prove it is safe. It has not yet, in my opinion, proven it should yet be standard of care. But as I said in my previous post, I believe it is heading there if it is what we think it is. Chief Medical Officer David Kendall MD indicated that more is coming: “These two presentations represent just two of the numerous disclosures we hope to publish in the coming months,” said David Kendall, M.D., Chief Medical Officer of MannKind Corporation. “These two studies are critical to helping build awareness of the potential clinical impact and longer term safety of Afrezza. These and other recently published data significantly advance our understanding of the treatment opportunity that Afrezza therapy may offer. MannKind’s medical, regulatory and safety teams are committed to ensuring that this information is made available to both individuals living with diabetes and the medical community alike, and we are pleased that we were able to share this data more broadly at EASD.” There are two clinical studies whose primary outcomes were estimated to be completed last week. I think it's reasonable for shareholders to look forward to addition ad hoc results being published from data collected in over a decade of clinical trials. Results from the vast majority of these Afrezza trials has never been published, according to Kendall.
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Post by sayhey24 on Oct 8, 2018 18:21:30 GMT -5
Mango - it seems you had a long day! I guess this statement would have gotten me going "I disagree that understanding does not require a medical degree, however. The human body is so complex and every system works with the other."
Thinking of innovation in the diabetes space in the last 50 years three names come to mind who have dramatically impacted its treatment; Ralph DeFronzo; Richard Bernstein; and Al Mann
Ralph for his contribution to making metformin the current standard of care for T2s. Of the three Ralph was the only doctor and 25 years later says metformin is the biggest waste of time in treating PWDs. So much for his contribution as we now try to bury this mistake.
Richard Bernstein was an engineer. He found his first glucose monitor in the back of a magazine but was not allowed to buy it because he was not a doctor. His wife was so she bought it for him. He then spend years trying to get the medical community to listen to him and was snubbed for many years. One of the reasons was he was not a doctor. In his forties he went to medical school and the rest is history.
The third guy is Al Mann. Like Bernstein Al was an engineer. Al never went to medical school but he taught medical innovation to many doctors.
Al thought afrezza was the greatest advancement in diabetes care since Banting and Bates and did the studies to prove it. Dr. Kendall who has now seen all of Al's work has called afrezza a superior insulin.
For those who say the study work has not been done, they are wrong. It will take Dr. Kendall some time in turning what seemed like the Titanic away from the iceberg and getting the standards of care updated.
For those who say early insulin intervention is not the best approach for most T2s, they are wrong. We have too many years of studies saying the opposite.
For those who say afrezza is not a superior meal time insulin, they are wrong. Nothing can replicate natural first phase insulin release like afrezza to stop the spike and get the PWD back to pre-meal BG levels with little chance of a severe hypo.
For those who say afrezza is not a superior insulin for reducing hypos in T1s, they are wrong. The Affinity-1, STAT and clinical use shows otherwise.
When it comes to innovation in the medical space its more often the engineer and not the doctor who makes things happens. Engineers always like the challenge of a complex machine.
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Post by letitride on Oct 8, 2018 19:54:40 GMT -5
This is an FDA approved drug and I am not a doctor, and my only letters are GED. But I do understand the current SOC sucks as I have lost one family member to diabetes about to see another loose his legs and another suffering from nuropathy. And today I go out and and meet a GP, and a soon to be nurse practitioner and neither have ever heard of afrezza. And when I showed the doctor the graph in the brochure as to fast in and fast out he understood and when I showed him that afrezza was a monomer not a hexomer he seemed to get that as well. So in conclusion I would say the doctor was ignorant only in as much as no one made this information available to him until today. And he was intelligent in that he didnt blow off my presentation because you know I didnt have the proper letters behind my name. Doc if your reading I want to say Thank You and should you decide to invest Good Luck; and if not please do take the time to prescribe.
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Post by sportsrancho on Oct 8, 2018 20:27:47 GMT -5
This is an FDA approved drug and I am not a doctor, and my only letters are GED. But I do understand the current SOC sucks as I have lost one family member to diabetes about to see another loose his legs and another suffering from nuropathy. And today I go out and and meet a GP, and a soon to be nurse practitioner and neither have ever heard of afrezza. And when I showed the doctor the graph in the brochure as to fast in and fast out he understood and when I showed him that afrezza was a monomer not a hexomer he seemed to get that as well. So in conclusion I would say the doctor was ignorant only in as much as no one made this information available to him until today. And he was intelligent in that he didnt blow off my presentation because you know I didnt have the proper letters behind my name. Doc if your reading I want to say Thank You and should you decide to invest Good Luck; and if not please do take the time to prescribe. Thank you letitride!
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Post by rockstarrick on Oct 8, 2018 23:18:57 GMT -5
Mango, You seem like a pretty intelligent person. I disagree that understanding does not require a medical degree, however. The human body is so complex and every system works with the other. While there isn't a human being alive that I've met that understands the whole human body, there comes a point where the more you learn the more you realize you don't know. At least the good doctors I've run into think that way... I've seen a lot of Mavericks that shoot from the hip do a lot of real harm to their patients because they made decisions that made sense at the time based on the evidence they had, but ended up being incorrect in the end. I realize this may be a bit brash, but I would encourage you to practice a little bit of humility. I assure you that the vast majority of doctors I have met are not stupid ( although some have been...) If there's something you don't understand or disagree with, it's good to question, but when it comes to the whole field of doctors behaving the same way, it's probably for good reason. I'm not saying you're wrong. I actually very strongly agree with what you're saying. I just don't have the same haste as you when it comes to implementing Afrezza as standard of care. I think it's certainly headed in that direction and if MNKD is sitting on convincing data that they need to publish it. It sounds as though they are... You need to understand that sometimes you don't know what you don't know (myself included) which is why medicine should be practiced so conservatively. It takes time and mistakes to test hypotheses out. There has been a lot of evidence to draw from, but we're still learning as we go. stevil , I couldn't agree with you more on "... there comes a point where the more you learn the more you realize you don't know ...". I'm sure you know its "Dunning-Kruger effect". I feel this every single day, now that I'm no longer fresh out of grad school (where I thought I knew everything). I haven't followed this whole thread. You have very valid points of being conservative in the medical field. But, when a new change comes in, there is a lot of push back ( unintentional - not wanting to change the known and trusted status-quo, intentional - the corrupt lobby protecting their turf). Afrezza is stuck in the middle. I hope the momentum that is being built, carries it forward. mango : And, I didn't know you have no formal education.. You write a lot of technical stuff. I honestly thought you are a PhD. Smart guy! :-) No doubt, Mango could probably slap a mean Bass 😜 Stevil meets Mango !!! What a combo,, I am looking forward to reading the dialogue. I have a lot of respect for both of you. ✌🏻😎
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Post by mango on Oct 9, 2018 11:25:34 GMT -5
stevil , I couldn't agree with you more on "... there comes a point where the more you learn the more you realize you don't know ...". I'm sure you know its "Dunning-Kruger effect". I feel this every single day, now that I'm no longer fresh out of grad school (where I thought I knew everything). I haven't followed this whole thread. You have very valid points of being conservative in the medical field. But, when a new change comes in, there is a lot of push back ( unintentional - not wanting to change the known and trusted status-quo, intentional - the corrupt lobby protecting their turf). Afrezza is stuck in the middle. I hope the momentum that is being built, carries it forward. mango : And, I didn't know you have no formal education.. You write a lot of technical stuff. I honestly thought you are a PhD. Smart guy! :-) No doubt, Mango could probably slap a mean Bass 😜 Stevil meets Mango !!! What a combo,, I am looking forward to reading the dialogue. I have a lot of respect for both of you. ✌🏻😎
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