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Post by agedhippie on Jul 12, 2024 9:58:03 GMT -5
... What if the doctors at the testing center told the AID people to turn off their AID at bedtime? How should we handle this? Do you see what you are saying? We should just accept this as the world of clinical trials? I am assuming that you mean the closed loop function rather than the AID pump itself (turning off the pump would be fatal). The short answer is that the patient would likely ignore the doctor. The world is not made up of ideal patients and until it is the trial process will not change - they need to know if the drug works in the real world and for what groups since one size does not fit all. |
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Post by sayhey24 on Jul 12, 2024 11:16:09 GMT -5
Sayhey, when you say "But, that is the way it use to be" you are ignoring the reality that THIS IS STILL THE WAY IT IS. It doesn't matter how we feel or how it should be. Its clearly not. When I would suggest 10 years ago CGMs should be incorporated into these trial I was laughed at. Five years ago I was just told thats not the way we do things. Now Inhale-3 had CGMs. When I first met Mike I am not sure if he knew what a CGM was as he was very new to the diabetes world but I told him CGM's and "connected care" were what would save afrezza. Now we have Inhale-3 and we not only used CGMs but we can tell that some people intentionally did not follow protocol. What we don't know is why. What we also know is when the PWDs did follow protocol nothing could compete with afrezza. We can see it right there in the CGM reports. The thing is CGMs don't lie and you can't hide the numbers. It just raises the question why did some intentionally not dose before bed. Was there a thought by someone that this would not be noticed yet a good way to deep six the results? IDK, maybe I have watched too many movies like Dopesick and lived the Martin Shkreli email a dozen years ago when Peggy Hamberg was running things at the FDA and her husband was running the hedge fund. What I can tell you is I fully expect BP will do what they can to stop afrezza getting insurance coverage and not having afrezza show superiority in Inhale-3 will go a long way in doing that. |
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Post by sayhey24 on Jul 12, 2024 11:26:15 GMT -5
... What if the doctors at the testing center told the AID people to turn off their AID at bedtime? How should we handle this? Do you see what you are saying? We should just accept this as the world of clinical trials? I am assuming that you mean the closed loop function rather than the AID pump itself (turning off the pump would be fatal). The short answer is that the patient would likely ignore the doctor. The world is not made up of ideal patients and until it is the trial process will not change - they need to know if the drug works in the real world and for what groups since one size does not fit all. Turning off the pump for their basal needs when they are sleeping would be fatal? I doubt that if they go to bed at 150. What it would do is jack up their A1c. No one doubts human insulin works in the real world. It works. This was a dosing study to show with proper dosing is afrezza as good as standard care. Then you get some people who do not want to follow the protocol after they agreed they would. Thats a bit fishy to me. Its not that they did not agree. They did and then didn't do it. They got caught. I guess you could call that lying. I don't think they expected to get caught but you can't hide the numbers from the CGM. |
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Post by agedhippie on Jul 12, 2024 12:24:43 GMT -5
Turning off the pump for their basal needs when they are sleeping would be fatal? I doubt that if they go to bed at 150. What it would do is jack up their A1c. No one doubts human insulin works in the real world. It works. This was a dosing study to show with proper dosing is afrezza as good as standard care. ... If you think turning off basal insulin overnight would not be fatal you don't understand how Type 1 works. If there is no insulin you will go into DKA and die, it's as simple as that - look up diabetic ketoacidosis. I know a person who died like that (pump occlusion and no CGM to alert). I think I understand your confusion now. This is not a dosing study, this is an A:B comparison between Afrezza and usual care. If it was a dosing study the whole thing could have stopped with the meal challenge. |
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Post by ktim on Jul 12, 2024 13:01:30 GMT -5
Wow... at least we have a new twist to the conspiracy theories. Trial participants bribed to ruin the results for Afrezza. As for HIPPA, maybe BP broke into each of the trial sites at night, Mission Impossible style, and installed bugs so that they could pick up patient names from conversation, with their surveillance teams in vans out in the parking lots. We've been notified by some here that BP views Afrezza as an existential threat, so there is no limit on what criminal things they will do.
I look forward to hearing more, this is a shocking and compelling narrative. I never would have imagined this is happening.
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Post by sayhey24 on Jul 12, 2024 14:08:33 GMT -5
Wow... at least we have a new twist to the conspiracy theories. Trial participants bribed to ruin the results for Afrezza. As for HIPPA, maybe BP broke into each of the trial sites at night, Mission Impossible style, and installed bugs so that they could pick up patient names from conversation, with their surveillance teams in vans out in the parking lots. We've been notified by some here that BP views Afrezza as an existential threat, so there is no limit on what criminal things they will do. I look forward to hearing more, this is a shocking and compelling narrative. I never would have imagined this is happening. Look, I was not the one who started this. Its was some of the presenters who highlighted some of the participants did not dose as instructed and the easy ones to pick out was pre-bed dosing. I can't tell if you seriously don't think this could happen. Of course it could. I watched as Brandicourt failed with Exubera at Pfizer but was then brought into Sanofi to deep six all the afrezza plans. Having reps whisper in the ear of some participant docs to make sure afrezza does not show superiority seems like a no-brainer to me. It is so easy to do. BTW, I was at the afrezza Adcom and did hear first hand some hallway discussions so nothing surprises me. I also heard the FDA review team publicly accuse the one doctor of cheating and tried to discredit him because he instructed his patients to follow-up dose which was allowed for the 171 and his PWDs crushed the RAA numbers. The question to be answered is why did these Inhale-3 participants intentionally not follow the protocol. Thats what I would like to hear more on plus what is Mike going to do about it. Are they properly dosing now for the October results? They better be. |
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Post by agedhippie on Jul 12, 2024 14:46:02 GMT -5
... The question to be answered is why did these Inhale-3 participants intentionally not follow the protocol. Thats what I would like to hear more on plus what is Mike going to do about it. Are they properly dosing now for the October results? They better be. Protocol says: The Afrezza-Degludec group will inhale Afrezza at meals and corrections and will inject insulin degludec once a day for the 17 weeks of the RCT Phase.The requirement on them is that they take Afrezza at meal times, and if decide they need a correction they use Afrezza to make the correction. That's it, that's the protocol. Your argument is that they are not following YOUR protocol. Unless altered dosing is explicitly mentioned (which it isn't, see protocol) dosing follows the label. |
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Post by sayhey24 on Jul 12, 2024 16:17:41 GMT -5
... The question to be answered is why did these Inhale-3 participants intentionally not follow the protocol. Thats what I would like to hear more on plus what is Mike going to do about it. Are they properly dosing now for the October results? They better be. Protocol says: The Afrezza-Degludec group will inhale Afrezza at meals and corrections and will inject insulin degludec once a day for the 17 weeks of the RCT Phase.The requirement on them is that they take Afrezza at meal times, and if decide they need a correction they use Afrezza to make the correction. That's it, that's the protocol. Your argument is that they are not following YOUR protocol. Unless altered dosing is explicitly mentioned (which it isn't, see protocol) dosing follows the label. "and corrections" - I don't make this stuff up. They were instructed to take a correction prior to bed according to several presenters. They did not take that correction. You can argue they followed the protocol but its clear from the CGM reports and presenters they did not take the correction. The bottom line is when the PWD took the required corrections as instructed afrezza kicked ass. In my world only those people who followed the protocol as instructed which is to "inhale Afrezza at meals and corrections" should get counted. In my world I really want to know why those people did not follow directions. I really don't think thats too much to ask. |
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Post by agedhippie on Jul 12, 2024 17:06:37 GMT -5
"and corrections" - I don't make this stuff up. They were instructed to take a correction prior to bed according to several presenters. They did not take that correction. You can argue they followed the protocol but its clear from the CGM reports and presenters they did not take the correction. ... Taking a correction is discretionary. Bottom line? This line of argument will get you nowhere with the clinical trial and the results will stand. |
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Post by letitride on Jul 12, 2024 18:53:45 GMT -5
There is nothing to argue here its the best human insulin on the market trial and error aside it changes peoples lives for the better.. Insurance will cover it before it cost them more not to.
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Post by mayday on Jul 12, 2024 19:27:23 GMT -5
There is nothing to argue here its the best human insulin on the market trial and error aside it changes peoples lives for the better.. Insurance will cover it before it cost them more not to. From your mouth to God's ears! |
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Post by sportsrancho on Jul 12, 2024 20:00:15 GMT -5
There is nothing to argue here its the best human insulin on the market trial and error aside it changes peoples lives for the better.. Insurance will cover it before it cost them more not to. ☺️👆🏻😉 |
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Post by Clement on Jul 13, 2024 6:14:45 GMT -5
Years ago, there was talk on this board about how extraordinary were the results of Afrezza with athletes. Seems like most of our examples of this were T1s and young. I don't hear about this any more. Was there ever a push by MNKD sales team to seek out docs who address athletes with diabetes? Swimmers? Runners? Triathlon competitors? Could there be a post-hoc analysis of any Afrezza trial (when data is available) to analyze possible success with the subset of participants who are athletes and T1?
sayhey thinks big. I think small.
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Post by mango on Jul 25, 2024 11:13:12 GMT -5
The participants who failed to follow protocol, in this case, failed to use Afrezza for corrections should be excluded from the final study results and only mentioned as a side note, IMO.
“The panel of INHALE 3 investigators suggested that poor candidates might include those patients with a fear of hypoglycemia that keeps them from dosing at bedtime, or who have a lot of auto boluses given by their automated infusion pump suggesting that they're not proactive about management.”
“Worsening appeared to be driven by high overnight values in those who skipped their correction dose before bed, explained Grazia Aleppo, MD, of Northwestern University in Chicago.”
“Outliers "didn't take their dose of TI [Technosphere inhaled insulin powder], let's be honest," Aleppo said. "There was supposed to be an optimization on the participant's side of taking the second dose of TI after dinner. And most importantly, it is the bedtime correction [that] makes a huge difference. For those who did, they got better results."”
Bottom line—Afrezza was superior when dosed correctly and protocol was followed (participants did not intentionally skip Afrezza correction doses).
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Post by sayhey24 on Jul 25, 2024 18:50:24 GMT -5
The participants who failed to follow protocol, in this case, failed to use Afrezza for corrections should be excluded from the final study results and only mentioned as a side note, IMO. “The panel of INHALE 3 investigators suggested that poor candidates might include those patients with a fear of hypoglycemia that keeps them from dosing at bedtime, or who have a lot of auto boluses given by their automated infusion pump suggesting that they're not proactive about management.” “Worsening appeared to be driven by high overnight values in those who skipped their correction dose before bed, explained Grazia Aleppo, MD, of Northwestern University in Chicago.” “Outliers "didn't take their dose of TI [Technosphere inhaled insulin powder], let's be honest," Aleppo said. "There was supposed to be an optimization on the participant's side of taking the second dose of TI after dinner. And most importantly, it is the bedtime correction [that] makes a huge difference. For those who did, they got better results."” Bottom line—Afrezza was superior when dosed correctly and protocol was followed (participants did not intentionally skip Afrezza correction doses). OK - so why didn't they take the bedtime dose? They agreed to taking the "correction" doses when they signed up and then didn't take them. Why? If it was not for the CGM reports we would never had know. After the first couple of times of not taking their doses, why didn't they get a call from the overseeing doctor asking what the hell are you doing? After being at the Adcom and hearing some of the hallway conversations and then Martin sends his Christmas email, nothing in the pharma world surprises me. The good news is you can't hide the numbers with the CGM and you are right, those peoples results should not be counted in the final results. They should be put in a category of "Intentionally Non-compliant". |
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