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Post by stevil on Dec 3, 2018 16:58:25 GMT -5
peppy , For the most part, I agree with everything above.Also, I meant what I said back then and I still do believe that Afrezza will be the gold standard for glucose control. We know that insulin is designed specifically to allow for the uptake of glucose into muscle and fat cells so it would logically follow that the insulin that does its job the quickest, most predictably, and safely would lend to the best control. All that to say, just because something is the gold standard in medicine does not mean that it is the go-to first step. Often times, the gold standard is actually the last step. Well, by definition it should be because it's pointless to continue past the gold standard, but in instances where other modalities are cheaper than the gold standard, there is a step process before getting to the gold standard. Other things are usually tried first. This is where pricing becomes an issue. If Afrezza were the cheapest AND the gold standard for insulins, it would undoubtedly be the go to first-line insulin therapy. As we know, this is not the case. It is my fear that unless/until profoundly convincing trials emerge, Afrezza is going to be stuck on the shelf and saved only for those who cannot control their disease with other insulin. I'm not going to say that it never happens because I don't have enough experience, but from the experience I have had, the only people I have seen who cannot get their A1c below 7 are ones that are 1. noncompliant 2. not properly dosing (amount or frequency) or 3. eating too much of/ or the wrong food. Supposedly Afrezza can knock out #3, but they still have to follow #1 and #2 to the T in order for Afrezza to have any real benefit over other insulins. If I had to put a number on it, from my limited experience mind you, #1 and #2 have made up over 75+% of the problem. I want to believe that Afrezza will solve #1 and #2 being that it is pain free, easy to do, and comes in pre-packaged doses that don't require much thinking, but I have not seen trials show that Afrezza has greater compliance and fewer dosing issues. There is still not a whole lot known about it that should be known by now. I'm really hoping that these studies will start to emerge. Peppy, as to the second part of your question regarding the first phase response- I'll be honest and say that we very briefly covered this topic in my first year. It is too specific since the only time it matters is when discussing Afrezza. Looking back, I'm actually surprised it got covered at all, but it did get mentioned, probably because my professor was trying to prepare us for anything we would encounter. All I can say to it is what is seen in the graphic. Beyond that, I couldn't really offer more information. It is kind of insignificant, though, since that is not a deal maker or breaker. That alone will not be a reason doctors choose to prescribe, at least as far as things have been studied. It is significant only in better controlling post prandial glucose, but that benefit in and of itself- as far as I know- has not been studied or shown to be significant. Hopefully you'll understand what I mean after reading this post in its entirety. If I need to further clarify, please let me know. Aged likes every other diabetes drug on the market, and would put the type two on a 800 calorie diet for his fun and pleasure. that is aged gig. What aged really wants is a cure. I would want that as well. So aged said gap-1 is perfect for the population you are talking about, type twos. There are type ones. 1.5 million of them in the USA. The closest thing to a cure outside of major lifestyle changes- although some modifications need to be made following surgery- is with bariatric surgery. The surgeon I rotated with did 10+/ week. I was pretty opposed to it prior to my rotation with him, but once you see people have success and lose weight they'd been struggling to lose for years, it really changed my heart. The gastric sleeve procedure is actually pretty low risk and can "cure" people of both diabetes and hypertension in the short time after surgery. It does require some adherence to a strict pre-op and post-op diet, but following that, most people resume their normal lives. The mechanism is believed to be tied to neurotransmitters in the lining of the stomach that communicate with the brain. In obese people, their stomachs distend and grow, to the normal "I'm full" receptors get thrown out of rhythm. So you keep eating because your brain never realizes it has taken up an adequate amount of food. By shrinking the stomach, it limits how much food people can eat so they avoid overeating. The byproduct of the surgery is decreased caloric intake, which leads to decreased adipokines, which leads to decreased insulin resistance, helping to increase weight loss. The lost body mass decreases angiogenesis, so there is less vasculature for the heart to have to perfuse, so it lowers blood pressure. If given the option between potentially taking insulin the rest of your life vs having a minor surgery that removes a part of your stomach that you won't miss, which would you choose? Oh, and the surgery also helps you lose those stubborn pounds you maybe have tried to lose for several years. If it were my family, I would do everything I could to avoid surgery, but if I didn't have the discipline or the genetics to avoid it, it's actually a pretty great option to have.
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Post by stevil on Dec 3, 2018 16:19:00 GMT -5
What's the stats on GLP-1s keeping people from developing chronic diabetes-related conditions? What's the stats for people on GLP-1s having to require increasing step therapy? These people have a problem with regulating their glucose. Afrezza takes care of that. Argue all day about this or that, but what are you doing by negatively reinforcing by giving the medically incorrect treatment? Someone complained about a person not understanding after a 30 minute glucose explaination, well take more time to help them understand. Days, weeks, months—does it really matter? That's not an excuse that works for me. You either want the best for people or don't. The choice is yours. That's my opinion. You don't have to like it, and I'm not looking for a reply full of excuses and reasons why you don't. Mango, You're an intelligent person, so I'm not sure why you're completely missing my message. I'll try again, for your sake, to try to help you understand. My wife and I just welcomed our first little one so I took an early Christmas break, so I'm a little more cheery than usual and have the time to reply while my wife and little one nap. I don't have the stats in front of me that you're seeking. However, I can tell you that whatever those stats are, they're a lot better than no therapy at all. Which is exactly what will happen if you prescribe something that your patient doesn't want to take and/or cannot afford. I have never made the assertion that Afrezza was inferior. I know this is not an issue of my communication skills because Aged already responded earlier in this thread fully understanding exactly what I was saying, not what I wasn't. Medically incorrect treatment? LOL. LOL. Sorry, had to do that one twice. By whose standards is it medically incorrect? Yours? Dude, you totally have a God complex! Get over yourself already! Days, weeks, months, does it really matter- actually, yes. This is another one of those things that you won't understand because you're not a doctor. It's not that doctors are any better than anyone else, it's that everyone has their own role to play. It would be foolish for me to spend that much time educating my patient. There are diabetes educators whose sole purpose is to do that. It would be a waste of my time in the sense that I need to take care of other patients and allow my support staff to take care of those kinds of issues. Education does not require medical decision making. Anyone can educate (although it's mostly done by nurses). Only doctors and practitioners can make medical decisions. Again, doesn't make me any better than my staff, it's just the most efficient way for a system to run. I need to do my job and only my job, otherwise my job doesn't get done. It's not my job to educate my patience. To a point, yes, but if it takes longer than 30 minutes, I need to be more creative and use my resources to my benefit to help my patients more effectively. If I spent that much time with one patient, I would be neglecting my other patients and not giving them the care THEY deserve. So, mango, I'll leave you with this... what are YOU doing for people with diabetes?
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Post by stevil on Dec 3, 2018 15:56:51 GMT -5
The problem is that there are no quantified results of the impact of Afrezza in the long term. Afrezza returns you to the baseline in two hours taken properly. The question is in the real world will it be taken properly, and if so by how many and for how long. This is complicated by the use of HbA1c as a proxy for the likelihood of complications, one day it will be TIR but the data is not there yet. Without a pivotal trial it is going to be a game of inches. GLP-1 is the perfect drug for the patient population that Stevil is talking about. This is a group that struggles to take drugs daily and you are asking them to take a changing dose of Afrezza every time they eat and to test and possibly follow up an hour later. That is to much of a load, they will not be able to deal with that. Taking a GLP-1 dose every Sunday is far more achievable. It doesn't matter how wonderful a drug is if people do not take it. peppy, For the most part, I agree with everything above. Also, I meant what I said back then and I still do believe that Afrezza will be the gold standard for glucose control. We know that insulin is designed specifically to allow for the uptake of glucose into muscle and fat cells so it would logically follow that the insulin that does its job the quickest, most predictably, and safely would lend to the best control. All that to say, just because something is the gold standard in medicine does not mean that it is the go-to first step. Often times, the gold standard is actually the last step. Well, by definition it should be because it's pointless to continue past the gold standard, but in instances where other modalities are cheaper than the gold standard, there is a step process before getting to the gold standard. Other things are usually tried first. This is where pricing becomes an issue. If Afrezza were the cheapest AND the gold standard for insulins, it would undoubtedly be the go to first-line insulin therapy. As we know, this is not the case. It is my fear that unless/until profoundly convincing trials emerge, Afrezza is going to be stuck on the shelf and saved only for those who cannot control their disease with other insulin. I'm not going to say that it never happens because I don't have enough experience, but from the experience I have had, the only people I have seen who cannot get their A1c below 7 are ones that are 1. noncompliant 2. not properly dosing (amount or frequency) or 3. eating too much of/ or the wrong food. Supposedly Afrezza can knock out #3, but they still have to follow #1 and #2 to the T in order for Afrezza to have any real benefit over other insulins. If I had to put a number on it, from my limited experience mind you, #1 and #2 have made up over 75+% of the problem. I want to believe that Afrezza will solve #1 and #2 being that it is pain free, easy to do, and comes in pre-packaged doses that don't require much thinking, but I have not seen trials show that Afrezza has greater compliance and fewer dosing issues. There is still not a whole lot known about it that should be known by now. I'm really hoping that these studies will start to emerge. Peppy, as to the second part of your question regarding the first phase response- I'll be honest and say that we very briefly covered this topic in my first year. It is too specific since the only time it matters is when discussing Afrezza. Looking back, I'm actually surprised it got covered at all, but it did get mentioned, probably because my professor was trying to prepare us for anything we would encounter. All I can say to it is what is seen in the graphic. Beyond that, I couldn't really offer more information. It is kind of insignificant, though, since that is not a deal maker or breaker. That alone will not be a reason doctors choose to prescribe, at least as far as things have been studied. It is significant only in better controlling post prandial glucose, but that benefit in and of itself- as far as I know- has not been studied or shown to be significant. Hopefully you'll understand what I mean after reading this post in its entirety. If I need to further clarify, please let me know.
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Post by stevil on Dec 2, 2018 15:25:57 GMT -5
Thanks for the kind words, falcon. It's been by far the hardest thing I've ever done, and I still have residency to look forward to, but it's already been so rewarding to play the very small part I have thus far in caring for patients. I can't imagine how much better it will be when I get to be the one dictating care.
Kudos to your SO for being persistent and going til the end. It takes a true passion to reach a PhD. I'm glad you get to play a part in it. There's no way I'd have gotten through school without my wife. She deserves more than her half of the credit.
I'm glad my debt burden is so high. At times it was the only thing keeping me moving forward. All in all, physicians live comfortably. If I really want to sell out and work endless hours, I've heard stories of every specialty making over 5-600k. The money is there if you know how to play the game and find it. I personally don't care to work that hard, but I will not ever be among the working poor, regardless. From what I've heard of PhD work, though, a good salary is not always guaranteed outside of teaching. Your SO is the one who should really be getting a pat on the back. I'm glad you seem to be understanding and appreciative of the effort it takes to reach that goal. Kudos to you also for being so supportive and being a good partner and teammate!
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Post by stevil on Dec 2, 2018 0:33:23 GMT -5
I agree. I remember getting flamed to death on here a few years ago for my negative views that ended up becoming reality. No matter the motivation, one should always keep an open mind. Know what you know and allow yourself to be challenged by what you don’t.My endorsement is also for matt, although I’ll probably also get lumped into the short brigade. Mike himself said way back when that shareholders would thank him someday for saving the company. I don’t think it was unreasonable for matt to predict bankruptcy. Those words sound pretty dire to me. stevil The time has come. You now get to prescribe. The standards of Care in what ever speciality/disease you end up in written. The revolving door of patients coming in. Now you get to see. These patients, the ones that will become yours, over time; you will get the visual, the lab results, the x-rays. Come back and let us know. - These pills/medications worked the patient got better. -These pills worked for this, caused that, new pills for that.... Come back and let us know, did the health of these people improve? I know you have read every word on the package insert of every prescription you give out, you know the organs that will be affected. That is part of the job description. I was at Mayo a few years ago, I watched the people come in the door. These people did not look well. Peppy, Not yet. I can't prescribe anything until June, but even then, I will need my supervising physician to sign off on it. I don't yet know where I'm going for residency, although I have been given a few winks from my top choice, but it's not a given that I will be able to prescribe Afrezza. I have already seen a lot of people have success with metformin and the GLP-1's. The nice thing about the latter (Trulicity) is that they only require a once/week injection schedule. Compliance is a huge hurdle with the diabetic population. Many don't care about their disease, others just are either uninterested or incapable of understanding the severity of their disease. I kid you not, I once spent 30 minutes counseling one of my patients in the hospital and at the end of it, she still didn't understand what glucose was or how/why her levels were so high. And I did my best to simplify it. Level of education is a hurdle. As awful as you and everyone else think it is (and I agree it is unfortunate), there is only a limited amount of time you get to spend with each patient as a physician. In my observation throughout the past year and a half, there seems to be a correlation between education level and glucose control. The more educated typically earn more money, buy healthier food, have better access to healthcare, and understand the importance of seeing their physician regularly and are able to interpret what their doctor tells them and make better choices because they understand the consequences of their decisions. I haven't looked it up to see if anyone has studied this, but what this means (again from my experience) is that diabetes is more of a disease of the poorly insured and less compliant, at least for the type 2 population. The issue that the majority of people on here don't seem to understand is that even though Afrezza may be the best solution for diabetes, it isn't the best solution for every person with diabetes. You can have the best drug in the world, but if people won't take it as they're supposed to, it isn't going to work all that well. Therefore, I've actually become a bigger fan of bariatric surgery (gastric sleeve) and GLP-1 use. Insurance coverage is still an issue with those, but they are so wonderful because they require less compliance from the patience to be effective. On top of this, I did a presentation in front of residents and supervising physicians last week, and had incredible difficulty compiling compelling trial data for the use of Afrezza for better glucose control. I found that I was forced to explain the science and why Afrezza "should" work better because the available trial data just does not support the use of Afrezza over other insulins. At best, Afrezza spent 9 fewer minutes every day in hypoglycemic ranges and less weight gain than RAAs with 1-2 hours more "in range" so an argument could be made for the use of Afrezza in those experiencing difficult control with multiple severe hypoglycemic events. At that point, safety takes precedence to overall magnitude of reduction, since Afrezza lowered A1c less than RAAs in nearly every arm that has been studied. At the end of the day, doctors are currently taught to treat to a number, not for control. I will do my best to convince my supervising physician to allow me to prescribe Afrezza, but the residency I'll hopefully be practicing at is in a very large hospital in a metropolitan area with the homeless and impoverished making up the majority of the patient population. Insurance will be an enormous hurdle. Going back to my previous example, counseling will be an enormous hurdle. I will get dinged in my residency if I spend too much time with my patients. Part of my education is learning how to be efficient. Then, once I start practicing independently, I'll have a tremendous debt burden that has been accruing interest since the day I stepped foot onto my medical school campus. As much as I want to help my patients, I first have an obligation to my family. Insurance doesn't pay you for spending longer than they deem necessary for an office visit. I can sometimes justify a higher level of billing if I document properly, but that takes even more time since thorough documentation takes considerably longer than normal documentation. For those who want to throw stones because of this, I would highly encourage you to tell your employer you don't want 20% of your paycheck every week. I will do my best for every one of my patients that I see. But my best will be different for each of them because you need to tailor care to what is attainable for each of them. Not every patient wants the best care. Not every patient is willing/able to do what is necessary to get the best results. The trick is to figure out what will be best for them and to work as hard as I can to help ensure they get what they want and need to achieve their goals.
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Post by stevil on Dec 1, 2018 11:36:36 GMT -5
I don't know what Matts motivations are either. But I must admit it's incredible to watch the conversations between Nate Pile and assorted users on Stocktwits. I don't know if it's the same person or multiple people, but "they" positions themselves as shareholders. Then they relentlessly question everything about the companies efforts. It's obvious to me "they" are short the stock and trying to undermine our (investors) confidence in the company so we'll sell to them (and they can cover their short). My question is whether anyone in our little community of retail stock owners actually buys into the BS? Nates made it pretty plain that he thinks there are a lot of people who own the stock and aren't going to sell and there are some people who shorted the stock and have made a lot of money on paper. If the company massively dilutes or goes out of business the short sellers realize those gains. However, that's largely off the table. So it's a stale mate. The short sellers are trying to get the investors they sold short shares to to sell them back at a lower price. I suspect Matt may be part of this effort. The thing that really blows me away is that the short sellers attacking the company are obviously intelligent and well-educated. The LFD pieces are well written and creative - if you can look past the fact they are complete nonsense. Likewise the attacks on Nate are also well orchestrated and clever. Just think if these people took that training and talent and put it to productive use for society. I wonder how they are able to reconcile what they do for a living internally. I put a lot of stock in the rudyrd Kipling poem the man in the glass. Are thes folks so devoid of any character or internal moral compass that they just don't care? I have stated it before but I don't find any issues with Matt's realistic view of the situation. Now, you may argue with my choice of the word "realistic" but before you do go check the share price. I believe, inasmuch as people don't want to hear it, that Matt is right. I have always found his posts to be a pragmatic and useful perspective. And is it not the right of shareholders who hand over their money to hold management's feet to the fire to achieve a return? This has been a dismal investment for most longs despite the superior nature of Afrezza. Also, please don't challenge anyone's right to post on this board. So long as they follow the rules then the reason they post should not be in question. A diversity of views is beneficial. It's your job to weed through them and develop your own perspective. I agree. I remember getting flamed to death on here a few years ago for my negative views that ended up becoming reality. No matter the motivation, one should always keep an open mind. Know what you know and allow yourself to be challenged by what you don’t. My endorsement is also for matt, although I’ll probably also get lumped into the short brigade. Mike himself said way back when that shareholders would thank him someday for saving the company. I don’t think it was unreasonable for matt to predict bankruptcy. Those words sound pretty dire to me.
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Post by stevil on Nov 17, 2018 16:42:18 GMT -5
I'd be careful what you wish for. Medical doctors can prescribe any FDA approved medication that they want at any time and for any reason. However, if a doctor prescribes a medication for a condition that the medication was not intended to treat and ends up harming the patient, you want the doctor to be able to be held liable for damages... Generally speaking. If you take away those restrictions, you're leaving all the power in the hands of the individual doctor. That's not as safe of a place to be compared to a body of evidence that can prove a therapy is safe and effective. I think you're failing to understand that someone or something will always be in charge of regulations. Is it better for one mind to make those decisions or potentially thousands of minds that check each other to see if they all agree before deciding on proper indications for therapy? Personally, I'd send my family to an evidence-based practitioner who is up to date on the current standards of medical practice. Unless I'm out of options after the standards have been exhausted and they're in a life-threatening situation. I think that's the point one should jump to experimental medicine- and not a moment sooner. It also seems as though you're misunderstanding the role of the FDA. No one at the FDA is telling doctors not to prescribe Afrezza. The FDA has already given their nod of approval. It's the docs themselves that are choosing not to prescribe. Nothing is stopping them. The FDA does not allow for unsubstantiated claims to be made. Meaning, all claims by drug manufacturers must be based on standardized protocols during clinical trials. Until those trials have been run and produced said claims, they're not allowed to be used for marketing purposes. Drug reps are allowed to point docs to the stat trial though. There are all sorts of data collections that docs have to sort through to separate the wheat from the chaff. But that's extremely time-consuming and inefficient. It's better for that responsibility to be delegated to someone else. Docs want to spend time with their patients for the most part (at least in my experience). Some enjoy research, but the vast majority are content allowing data collectors do the grunt work to form recommendations. FDA approves drugs without ever identifying the MOA. That is lunacy. FDA profits handsomely from the fees they require of tobacco companies in exchange for allowing them to play in US commerce. These tobacco companies, many of whom are also publicly traded on US stock markets, have the FDA's blessing to profit off induced illnesses, diseases, cancers. I completely disagree. You mean to tell me that if a cancer researcher stumbled upon a cure to cancer that it should be kept off the market until the mechanism could be made known? If a drug is safe and proves to have a beneficial outcome, who cares about the mechanism? Is there increased risk involved without knowing the mechanism? Probably. Much of medicine is chemistry. They teach us in medical school that "All things are poison, and nothing is without poison, the dosage alone makes it so a thing is not a poison." -Paracelsus. I assume you're referencing metformin for your argument. It would be a shame if metformin were never FDA-approved simply because the mechanism wasn't known. Its active ingredient comes from the French lilac flower and people have been using it for centuries. As awful as tobacco is for health, I think it's criminal to take away someone's right to use it. Informed consent happens all the time and doctors are taught to appreciate their patients' autonomy in decision making. I would never want the government taking away any one of my rights that does not impinge upon my fellow man. In that same breath, I would not be opposed to charging parents who smoke in their children's presence with child abuse. The FDA makes it so that doctors cannot harm their patients. For diseases that have no other treatment options, the FDA grants more leeway, so long as the risks don't outweigh the benefits. Much of medicine is constantly making decisions balancing between the two.
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Post by stevil on Nov 17, 2018 1:50:05 GMT -5
I'd be careful what you wish for. Medical doctors can prescribe any FDA approved medication that they want at any time and for any reason.
However, if a doctor prescribes a medication for a condition that the medication was not intended to treat and ends up harming the patient, you want the doctor to be able to be held liable for damages... Generally speaking. If you take away those restrictions, you're leaving all the power in the hands of the individual doctor. That's not as safe of a place to be compared to a body of evidence that can prove a therapy is safe and effective.
I think you're failing to understand that someone or something will always be in charge of regulations. Is it better for one mind to make those decisions or potentially thousands of minds that check each other to see if they all agree before deciding on proper indications for therapy?
Personally, I'd send my family to an evidence-based practitioner who is up to date on the current standards of medical practice. Unless I'm out of options after the standards have been exhausted and they're in a life-threatening situation. I think that's the point one should jump to experimental medicine- and not a moment sooner.
It also seems as though you're misunderstanding the role of the FDA. No one at the FDA is telling doctors not to prescribe Afrezza. The FDA has already given their nod of approval. It's the docs themselves that are choosing not to prescribe. Nothing is stopping them.
The FDA does not allow for unsubstantiated claims to be made. Meaning, all claims by drug manufacturers must be based on standardized protocols during clinical trials. Until those trials have been run and produced said claims, they're not allowed to be used for marketing purposes. Drug reps are allowed to point docs to the stat trial though. There are all sorts of data collections that docs have to sort through to separate the wheat from the chaff. But that's extremely time-consuming and inefficient. It's better for that responsibility to be delegated to someone else. Docs want to spend time with their patients for the most part (at least in my experience). Some enjoy research, but the vast majority are content allowing data collectors do the grunt work to form recommendations.
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Post by stevil on Nov 6, 2018 15:00:09 GMT -5
What you’re talking about has already happened. Afrezza is FDA approved. There is a huge difference between being approved and being recommended.
Recommended means first line therapy, meaning it’s the go to drug that everyone with the disease gets put on before anything else. Approved means it has passed the initial trial period and has been shown to be safe and is allowed to be prescribed.
No one is stopping physicians from prescribing Afrezza. They’re simply waiting for more data. Despite what anyone on here says, time is the best gauge of safety. Medicine/technology isn’t sophisticated enough to have a single test or even group of tests to prove safety. They can all point in that direction, but it’s a consensus of information that gets used to paint the whole picture. It’s not uncommon for retrospective studies to show causality that once passed through initial testing. You’re right that at some point enough is enough. Who knows when that time will be, but it’s not in the near future unless the hidden data is extremely compelling. Dr. Kendall knows more than any of us and seems confident that he can get it done, so I’ve got hope.
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Post by stevil on Oct 29, 2018 20:23:36 GMT -5
To rephrase uvula, what good is it if 0% of the people who need Afrezza get it? If Mike is a man of integrity and means what he says, he's committed to making sure everyone who wants Afrezza will have access to it, unless they are on Medicare, in which case his hands are tied. MNKD is still a bit in survival mode. They can't frivolously waste resources. Every dollar earned now has the opportunity to compound into several later. So being patient now will greatly pay off for multiples more people later when they become more established. I was very critical of the former management team. Mike has impressed me thus far with his ability to do so much with so little. He's got grit and determination and the networking skills to find the right people to get done what he needs done. Don't stop complaining on my accord, but many of the complaints that I read on this board are ill-founded. There are very intelligent and capable people that are being criticized unfairly. If one were to walk a mile in their shoes, they would understand the complexity and difficulty in solving the oft-complained about issues. There are rules to systems- some that should exist and some that shouldn't. In this case, it's unfortunate that Medicare doesn't allow rebates to be used, but they have to protect against fraud. It's sad that there are people and doctors who abuse systems and that a few bad apples spoil the bunch, but when you're as large of an entity as Medicare and it's your job to ensure as many people have access to healthcare as the system can support, they must put rules and regulations in place to protect it. I'd like to encourage you to keep hope, advocate for those who can't (or won't) and be grateful that men like Mike exist who are trying to right some of the wrongs that exist in this world. The story is continuing to improve and what you're pining for will hopefully be available soon. Sorry if it seems like I'm patronizing or lecturing. That's not my intent. Just trying to help give perspective. I think afrezza IS the best rapid acting insulin. As much as I like you stevil, I heard you when you typed, "if it isn't covered by insurance, just order the one that is." I would like a physician that cares about me and what I want. To hard? Just trying to give some different perspective. I’m not seeing the conflict you’re describing. Would you want me to prescribe the very best medication that you can’t afford or prescribe something that will allow you to live a high quality of life for several decades that you can afford?
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Post by stevil on Oct 29, 2018 19:58:48 GMT -5
Alethea: Wow. I can understand your frustration but your post is way over the top. And a major price reduction would probably destroy the company. Things are looking up. Hang in there. Over the top? I hardly think so. Afrezza is priced like a Ferrari or Bentley.... when it needs to be priced liked a Toyota Corolla... thereby increasing script sales by 5 or 10 times. And the point is cutting the price in half might triple or quadruple the sales. What good is a miracle drug if less than a small fraction of 1% of the people who need it can ever get it. Al said he wanted to help diabetics and the simple reality is that very, VERY FEW are being helped at this ridiculously exorbitant price. To rephrase uvula, what good is it if 0% of the people who need Afrezza get it? If Mike is a man of integrity and means what he says, he's committed to making sure everyone who wants Afrezza will have access to it, unless they are on Medicare, in which case his hands are tied. MNKD is still a bit in survival mode. They can't frivolously waste resources. Every dollar earned now has the opportunity to compound into several later. So being patient now will greatly pay off for multiples more people later when they become more established. I was very critical of the former management team. Mike has impressed me thus far with his ability to do so much with so little. He's got grit and determination and the networking skills to find the right people to get done what he needs done. Don't stop complaining on my accord, but many of the complaints that I read on this board are ill-founded. There are very intelligent and capable people that are being criticized unfairly. If one were to walk a mile in their shoes, they would understand the complexity and difficulty in solving the oft-complained about issues. There are rules to systems- some that should exist and some that shouldn't. In this case, it's unfortunate that Medicare doesn't allow rebates to be used, but they have to protect against fraud. It's sad that there are people and doctors who abuse systems and that a few bad apples spoil the bunch, but when you're as large of an entity as Medicare and it's your job to ensure as many people have access to healthcare as the system can support, they must put rules and regulations in place to protect it. I'd like to encourage you to keep hope, advocate for those who can't (or won't) and be grateful that men like Mike exist who are trying to right some of the wrongs that exist in this world. The story is continuing to improve and what you're pining for will hopefully be available soon. Sorry if it seems like I'm patronizing or lecturing. That's not my intent. Just trying to help give perspective.
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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 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 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 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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