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Post by Deleted on Dec 15, 2015 13:15:09 GMT -5
yes, I have seen the video. Have you ever seen Jonathan Stewart rip Cramer? Pretty funny stuff. Apparently Motley Fool works in the same ways, writing hit pieces about Mannkind while recommending Novo.... maybe it's as easy as buying some ad space. Just like any kind of hanky panky sooner or later people talk. From all of the reports of patients finally getting their Afrezza after long waits, Friday mornings might be something to look forward to. Fridays havent been fun. |
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Post by thoth on Dec 15, 2015 13:18:05 GMT -5
"Users report...." Therein lies a problem. To really compare, you need some sort of well documented lifestyle/therapy history before and after starting afrezza. More importantly for afrezza, there needs to be solid clinical documentation to show insurance companies that patients in general are getting consistent improved results and that those results are in some fashion due to afrezza. This sort of documentation invariably requires a large and prolonged trial. I can't find anywhere that Sanofi has indicated whether they plan on any other trials other than those mandated by the FDA. MNKD has discussed label improvement trials as something SNY plans. So they are being led to believe it is SNY intention. Also, as noted today in this thread, the Afrezza medical professional advisory committee is apparently being led to believe that is the case... as it sure seems they are implying it isn't merely a non-inferior safety study being planned. I don't see why the trial would need to be particularly large or prolonged. Unlike a safety study, it is not looking for a rare event. A safety study needs thousands of patients in order to statistically tease out whether the are changes in the infrequent occurrence rate of something like cancer. If the occurrence rate for better blood sugar control is so infrequent as to need thousands, it would also be meaningless. Likewise, something like lower post meal spikes and better average glucose without increased dangerous hypos could be demonstrated with a CGM with a trial lasting 2-3 months... or maybe 4-5 if A1c readings desired. Your previous comment about patients likely being able to achieve the same control with traditional RAA/basal mix seems to be in total opposition to what many users are saying. I'm not a diabetes specialist but have taken control theory in engineering curriculum and it certainly makes total sense to me that have an RAA with a time constant that doesn't match what one wants to eat would pose far more problems than Afrezza that in some circumstances may have too brief action. Granted if a patient were willing to always eat a meal to match RAA's long tail, they might be able to simplify their life... but they also would likely pack on pounds to their health detriment as they would be needing to always plan for a fat laden meal that takes hours to digest and generates enough blood sugar for the body's cells (many of them fat cells) to feast on for hours. RAA's simply present trade offs... put up with higher post meal spikes and subsequent A1c, or deal with the fact that the RAA tail doesn't match the digestion rate of a healthy diet. Dreamboatcruise, that's a very interesting point that you make about the trial design. If the impact that is being evaluated is predicted to be very large vs. the control, that lowers the sample size requirements fairly drastically. And ditto on the controls issue with RAAs. Psychology studies have shown that human beings are typically terrible at managing systems with major time lags. I would find it hard to believe that most people could achieve the same level of control with a longer vs. shorter time lag. |
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Post by peppy on Dec 15, 2015 13:28:49 GMT -5
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Post by dreamboatcruise on Dec 15, 2015 14:08:46 GMT -5
Someone evaluating risks differently than you do does not make them a hypocrite, unless you are implying he has some ulterior motive and what he expresses is not genuine. Yes, I do realize there are many who think any less than glowing comment about Afrezza must be orchestrated by the evil forces of the shorts. It is the doctor not the blogger that seems to have questioned SNY's commitment to Afrezza. I am sorry but I respectfully disagree. The author Mike Hoskins takes a lot of pictures of unhealthy food and alcoholic beverages and posts them on his twitter account. I am sure I do not need to explain how a poor diet and drinking alcohol with diabetes is not too bright for his long term health. Its no different then a smoker saying I wont take Afrezza because of the unknown lung issues. I have no idea what his motives are. It seems Afrezzauser has already publicly questioned his motives. I am far from a short conspirator if that is what you are implying. This is all plain as day on Twitter. I am also reading the article different then you. I see it that he is making the comments about SNY dropping Afrezza not the Dr. He clearly states his opinion about SNY dropping Afrezza and then transitions into the Dr's comments. The comment "So if you haven’t tried it, or the doctors haven't offered or discussed it with patients, time might be running out!" is after the big title "A Guest Post on Afrezza by Jeremy Pettus" and before the wrap-up in italics saying "Thanks for sharing your POV, Jeremy. Like you, we are nervous about the inhaled insulin's future, and hope to see it stick around as a valuable tool for us PWDs", so it seems pretty clear that is a statement written by Dr. Pettus. The blogger does point out that SNY has the ability to back out in Jan (a well known fact), but in that part before Dr. Pettus comments it merely states that MNKD would need to take over the marketing, it doesn't imply the death of Afrezza as is implied by Dr. Pettus that "time might be running out" to get it. Others may parse or weight those two statements differently, but clearly Dr. Pettus has questioned whether Afrezza will remain available. As for "poor" diet... given that guidelines for what is a good vs poor diet seem to constantly change you'd need to explain to me which version you believe in... and what is your source of certainty that you are right. Granted, if the guy is saying he consumes 5 drinks a day, you may have a point... but one can snap a picture of a drink and certainly that would fall within what some doctors consider as being beneficial, even for diabetics. Exubera had some inconclusive data that did cause some to question its cancer risk. MNKD felt it prudent, for perception or otherwise, to perform extensive tests addressing this perceived risk. The FDA is requiring long term safety studies. I think it bizarre to criticize someone that chooses to weigh that as a factor in their decisions. He seems to indicate he may well consider the benefit worth the level of risk he perceives. I'll fault someone that claims there is evidence of lung or cancer risk, because there isn't... but long term safety isn't proven until the long term studies have been done. |
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Post by dreamboatcruise on Dec 15, 2015 14:18:39 GMT -5
Here is Mike on his website talking about how the low alarm on his Dexcom sometimes keeps him up so he turns it off. If he used Afrezza, he could keep his alarm on and he would never hear it because the nighttime low issue would no longer exist. www.thediabeticscornerbooth.comThanks. I was thinking maybe I was being too harsh but not so much after reading that. What an evil man wanting to get sleep... and all those other evil people with diabetes that are refusing to use Afrezza. It's enough to make steam come out of this shareholder's ears. We need to scold and chastise them... for their own good. When I know so much more about what they need than they and their doctors do, it is almost a moral obligation for me to try to impose my will.  |
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Post by Deleted on Dec 15, 2015 15:26:04 GMT -5
I am sorry but I respectfully disagree. The author Mike Hoskins takes a lot of pictures of unhealthy food and alcoholic beverages and posts them on his twitter account. I am sure I do not need to explain how a poor diet and drinking alcohol with diabetes is not too bright for his long term health. Its no different then a smoker saying I wont take Afrezza because of the unknown lung issues. I have no idea what his motives are. It seems Afrezzauser has already publicly questioned his motives. I am far from a short conspirator if that is what you are implying. This is all plain as day on Twitter. I am also reading the article different then you. I see it that he is making the comments about SNY dropping Afrezza not the Dr. He clearly states his opinion about SNY dropping Afrezza and then transitions into the Dr's comments. The comment "So if you haven’t tried it, or the doctors haven't offered or discussed it with patients, time might be running out!" is after the big title "A Guest Post on Afrezza by Jeremy Pettus" and before the wrap-up in italics saying "Thanks for sharing your POV, Jeremy. Like you, we are nervous about the inhaled insulin's future, and hope to see it stick around as a valuable tool for us PWDs", so it seems pretty clear that is a statement written by Dr. Pettus. The blogger does point out that SNY has the ability to back out in Jan (a well known fact), but in that part before Dr. Pettus comments it merely states that MNKD would need to take over the marketing, it doesn't imply the death of Afrezza as is implied by Dr. Pettus that "time might be running out" to get it. Others may parse or weight those two statements differently, but clearly Dr. Pettus has questioned whether Afrezza will remain available. As for "poor" diet... given that guidelines for what is a good vs poor diet seem to constantly change you'd need to explain to me which version you believe in... and what is your source of certainty that you are right. Granted, if the guy is saying he consumes 5 drinks a day, you may have a point... but one can snap a picture of a drink and certainly that would fall within what some doctors consider as being beneficial, even for diabetics. Exubera had some inconclusive data that did cause some to question its cancer risk. MNKD felt it prudent, for perception or otherwise, to perform extensive tests addressing this perceived risk. The FDA is requiring long term safety studies. I think it bizarre to criticize someone that chooses to weigh that as a factor in their decisions. He seems to indicate he may well consider the benefit worth the level of risk he perceives. I'll fault someone that claims there is evidence of lung or cancer risk, because there isn't... but long term safety isn't proven until the long term studies have been done. Are you over weight? Maybe thats why you find it bizarre and are more accepting of it not being a big deal. Yes, I think it is hypocritical for someone who is over weight to talk about their concerns for their lungs when they have no control over what they consume. Its clear as day that he states SNY could drop MNKD and than transitions into the Dr's comments. The Dr also states the same thing in a stronger negative light. I am wrong that it was just the blogger. I have no idea how many beverages he consumes a day but I am pretty positive no Dr is going to be ok with the type of beer he is drinking. Most of his pictures are of what looks to be very high caloric (ton of sugar) thick beer. I bet those beers wreck havoc on his blood sugar. How do I know this? Because I would never waste my daily calories and drink a beer that is equalivlent to a meal. This is how you get fat. I am 210lbs 6'3 and am probably about 16% body fat (google that if you need a visual). I have been active my whole life. In the past five years I haven't missed going to the gym for more then about 30 days. For the past three years I have trained MMA and spare (light contact) with amatuer fighters half my age once a week. I measure my macro nutrients down to the precise amount of grams of protein, carbs and fat measured by my tdee (total daily energy expenditure). I also do yoga once a week to stay flexible to prevent injuries as I get older. So I am pretty confident in my ability to decipher what is and isn't healthy as I am almost 40 and have the body of a man in his 20's and its because of my discipline through my diet. If you need cholesterol levels also let me know. |
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Post by thekindaguyiyam on Dec 15, 2015 16:19:21 GMT -5
I am 210lbs 6'3 and am probably about 16% body fat (google that if you need a visual). I have been active my whole life. In the past five years I haven't missed going to the gym for more then about 30 days. For the past three years I have trained MMA and spare (light contact) with amatuer fighters half my age once a week. I measure my macro nutrients down to the precise amount of grams of protein, carbs and fat measured by my tdee (total daily energy expenditure). I also do yoga once a week to stay flexible to prevent injuries as I get older. So I am pretty confident in my ability to decipher what is and isn't healthy as I am almost 40 and have the body of a man in his 20's and its because of my discipline through my diet. If you need cholesterol levels also let me know.for someone who posts as a "female" you must have some issues. or am I getting this wrong too? Latest Status: Birthday: August 1 Gender: Female Posts: 69 Date Registered: Dec 4, 2015 at 11:15am Read more: mnkd.proboards.com/user/2140#ixzz3uQWqa6vu
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Post by Deleted on Dec 15, 2015 16:34:26 GMT -5
I am 210lbs 6'3 and am probably about 16% body fat (google that if you need a visual). I have been active my whole life. In the past five years I haven't missed going to the gym for more then about 30 days. For the past three years I have trained MMA and spare (light contact) with amatuer fighters half my age once a week. I measure my macro nutrients down to the precise amount of grams of protein, carbs and fat measured by my tdee (total daily energy expenditure). I also do yoga once a week to stay flexible to prevent injuries as I get older. So I am pretty confident in my ability to decipher what is and isn't healthy as I am almost 40 and have the body of a man in his 20's and its because of my discipline through my diet. If you need cholesterol levels also let me know.for someone who posts as a "female" you must have some issues. or am I getting this wrong too? Latest Status: Birthday: August 1 Gender: Female Posts: 69 Date Registered: Dec 4, 2015 at 11:15am Read more: mnkd.proboards.com/user/2140#ixzz3uQWqa6vu Haaaaaaa. Def not a female but thanks for the interest. The pink was a nice touch! |
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Post by thekindaguyiyam on Dec 15, 2015 16:50:21 GMT -5
reverselo
I wasn't the one who posted your original gender in your profile. Presumably, you did. I just noticed a contradiction in what you say as a male and how you identified yourself as a female.
Glad you liked the pink.
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Post by Deleted on Dec 15, 2015 17:00:17 GMT -5
I always up for a good ribbing. I would call it a typo more then a gender identity issue.
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Post by thekindaguyiyam on Dec 15, 2015 17:03:02 GMT -5
maybe you can work that out with your counselor. glty
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Post by Deleted on Dec 15, 2015 17:11:48 GMT -5
Thanks stalk my profile again in couple of months and maybe I will have it figured out
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Post by thekindaguyiyam on Dec 15, 2015 17:18:19 GMT -5
you posted your gender as a female. then you posted that you are a 40 year old male who said you look like you are in your 20's. I'm not making this up. No one else created your profile except for you. I don't stalk. I research. As it has been expressed to us here by moderators, "it is best to read the poster's previous posts before replying to them" was good advice. Deal with it. If you are a male pretending to be a female at least get a tin foil hat and make believe all you want. The criteria for your credibility is determined by your words; not mine.
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Post by suebeeee1 on Dec 15, 2015 17:22:11 GMT -5
And, "Do you believe this is a systemic benefit of Afrezza, and if so what is the mechanism for this?" I doubt afrezza in itself contributes much to lowering A1C. I think the "mechanism" for what develops is simply that the users are more highly motivated to succeed and end up doing a better job of attending to their illness -- checking their glucose regularly and more frequently, better attention to dosing time and frequency, more attention to proper diet, augmenting effects through exercise, etc. The extent to which afrezza's ease of use augments attending to those details would arguably be a benefit. On the other hand, I suspect the same could be accomplished even with old fashioned humulin 70/30 if the motivation was there. I am not sure that this is correct. Users report being able to eat more spontaneously and also to eat more foods like pizza or ice cream and still manage blood glucose successfully. Here is a recent Twitter comment as one example of many. Gustavo Basualdo @guasaman 8h8 hours ago Being able to go hard in the pool, and then eat all the recovery carbs I need with no crazy planning/bolus/counting is sooo awesome #afrezza How true!. This is a common scenario:. Dinner was 3 hours ago. His highness decides he would like a big bowl of no sugar added ice cream or pretzels (both of which would previously send his blood sugar soaring and morning numbers near 180). No thought. No calculations. Take out his whistle, puff, and like magic, no real rise in bg, no morning hangover numbers. The effect is so guaranteed that he no longer tests before or after. Magic! |
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Post by peppy on Dec 15, 2015 17:29:20 GMT -5
I am not sure that this is correct. Users report being able to eat more spontaneously and also to eat more foods like pizza or ice cream and still manage blood glucose successfully. Here is a recent Twitter comment as one example of many. Gustavo Basualdo @guasaman 8h8 hours ago Being able to go hard in the pool, and then eat all the recovery carbs I need with no crazy planning/bolus/counting is sooo awesome #afrezza How true!. This is a common scenario:. Dinner was 3 hours ago. His highness decides he would like a big bowl of no sugar added ice cream or pretzels (both of which would previously send his blood sugar soaring and morning numbers near 180). No thought. No calculations. Take out his whistle, puff, and like magic, no real rise in bg, no morning hangover numbers. The effect is so guaranteed that he no longer tests before or after. Magic! that is the thing suebeee these people can eat now. screencast.com/t/FCB6F8Sij
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