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Post by saxcmann on May 12, 2016 12:09:49 GMT -5
Label change is still a long way away.... Why? Could be closer than you think... |
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Post by cathode on May 12, 2016 12:43:25 GMT -5
Great letter. I hope the mnkd marketing people see this. "It's inhaled" should not be the focus. I'm sure Matt/Mike & Co. are working 24/7 to focus on label changes. Let's hope the company can survive long enough to market the product with an enhanced label. I don't think that is really true. The label isn't great by any means, but there is more to talk about than just the fact that it is inhaled. The PK/PD profile section is generally positive but still not as great as we know it to be. From 12.3 in the label: "The maximum serum insulin concentration was reached by 12–15 minutes after inhalation of AFREZZA 8 units and serum insulin concentrations declined to baseline by approximately 180 minutes." [Subcutaneous insulin is shown to have maximum concentrations 45-75 minutes after injection; baseline achieved at around 210-240 minutes] <-- added by me From 12.3: "Systemic insulin disposition (median terminal half-life) following oral inhalation of AFREZZA 4 and 32 units was 28–39 minutes, and 145 minutes for subcutaneous regular human insulin 15 units." I see nothing wrong with the phrase "Afrezza is faster absorbing than Insulin Lispro." |
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Post by bradleysbest on May 12, 2016 13:41:10 GMT -5
I do not believe a label change is a priority at this moment as a lot of work needs to be done for the 2.0 launch....
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Post by lakon on May 12, 2016 14:56:48 GMT -5
It didn’t help that the Afrezza instructions tried to do the units matching as well. I was suffering what I named the Afrezza “seesaw effect”: I would take Afrezza, the thing would act quickly, it would look as I was going to crash, so I over corrected, then Afrezza would go away as it has a short tail. Tom's son did not have this issue because he had never taken insulin before. If he ate a whole pizza then he would need more. ( Maybe it's easier for new diabetics?) Just a thought. Yes, T2 insulin naive would be ideal, but dogma is less than ideal. |
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Post by lakon on May 12, 2016 15:28:46 GMT -5
Even Afrezza's most zealous advocates state that they had to figure out how to use Afrezza during the first few days/weeks. I wonder if it's possible for an Afrezza App to be created that would help in this process. Each diabetic is different, so I think that having an App where you could "plug in" key data and it would give you dosing recommendations would be fantastic.
I suppose the FDA might want to have a say, though...  An App is a great idea , but probably cannot be created by Mannkind , because as you state the FDA may not permit that . However , there is nothing to prevent the Prescribing Endocrinologist or PCP from creating their own "handout or pamphlet " and give them to their pts as guidelines, this is done all the time in medical practices , and applies to meds that need to be adjusted on a sliding scale or titrated . As long as it is given to the patient by the physician or nurse practitioner, and the pt has the ability to get timely response to questions by the MD or NP , the FDA cannot dictate the dose for every patient , as the dose requirements and adjustments are highly individualized. Good ideas. MattB wanted to create the HOWTO Afrezza Manual after he figured things out with his testing and endo. Need to ping him on that and if he needs more funding. Also, should try to make it into a template for doctors to download from Just Breathe... Long-term an app with a NIR spectrometer could calculate the correct dosage amount and timing. If the handheld spectrometer works well enough, this app could be accomplished within the year for a dedicated team. mnkd.proboards.com/post/67458/thread |
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Post by edvarney on May 12, 2016 15:38:57 GMT -5
Gustavo!!! Terrific life story man.. I am so proud of you in your Afrezza success story and sharing all of this life experience as a longterm type1 diabetic. I just wish your story could somehow reach all type1 s out there . You know that they all shared much of your experiences as a diabetic. It is people like yourself that would have the greatest infuence on others who share your disease.
Too many fudsters out there today after 1 year of Afrezza experiences in the real world, and the private lives of people tend not to be shared expecially if they are successful like yourself..You only tend to hear the negatives that people experience with diabetes..
I strongly suggest to you, if you want to be helpful others, and I know you do, just reach out to the new leadership at MNKD, Mike Castagnas and share your first year experience with him if you havent all ready. ok!
I am willing to bet that Mike C. will be wanting to tap you and all the early adopters from Sam Fintas collection of users for 1 year updates on life experiences since starting Afrezza. Your inputs could be the final touches to an all ready great diabetic tool for all.
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Post by compound26 on May 12, 2016 17:24:52 GMT -5
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Post by rockstarrick on May 12, 2016 18:08:22 GMT -5
It didn’t help that the Afrezza instructions tried to do the units matching as well. I was suffering what I named the Afrezza “seesaw effect”: I would take Afrezza, the thing would act quickly, it would look as I was going to crash, so I over corrected, then Afrezza would go away as it has a short tail. Tom's son did not have this issue because he had never taken insulin before. If he ate a whole pizza then he would need more. (Maybe it's easier for new diabetics?) Just a thought. I'm sure insulin introduction of any kind requires some amount of learning. It sounds to me like getting injected insulin dialed in is an ongoing battle. Nice to hear that once he figured out how to properly use afrezza he could go thru his day without even thinking about diabetes. Quite the story. |
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Post by beardawg on May 13, 2016 5:53:00 GMT -5
An App is a great idea , but probably cannot be created by Mannkind , because as you state the FDA may not permit that . However , there is nothing to prevent the Prescribing Endocrinologist or PCP from creating their own "handout or pamphlet " and give them to their pts as guidelines, this is done all the time in medical practices , and applies to meds that need to be adjusted on a sliding scale or titrated . As long as it is given to the patient by the physician or nurse practitioner, and the pt has the ability to get timely response to questions by the MD or NP , the FDA cannot dictate the dose for every patient , as the dose requirements and adjustments are highly individualized. Good ideas. MattB wanted to create the HOWTO Afrezza Manual after he figured things out with his testing and endo. Need to ping him on that and if he needs more funding. Also, should try to make it into a template for doctors to download from Just Breathe... Long-term an app with a NIR spectrometer could calculate the correct dosage amount and timing. If the handheld spectrometer works well enough, this app could be accomplished within the year for a dedicated team. mnkd.proboards.com/post/67458/threadI doubt doctors would visit someone's personal website for instructions on giving a drug that can kill if given wrong (or any drug for that matter). |
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Post by lakon on May 16, 2016 12:44:03 GMT -5
Good ideas. MattB wanted to create the HOWTO Afrezza Manual after he figured things out with his testing and endo. Need to ping him on that and if he needs more funding. Also, should try to make it into a template for doctors to download from Just Breathe ...Long-term an app with a NIR spectrometer could calculate the correct dosage amount and timing. If the handheld spectrometer works well enough, this app could be accomplished within the year for a dedicated team. mnkd.proboards.com/post/67458/thread I doubt doctors would visit someone's personal website for instructions on giving a drug that can [uncertainty] kill [fear] if given wrong (or any drug for that matter). Whether intentional or not, the FUD does not aid in the process of creating practical solutions. In response to an open letter to MNKD, this thread has become an open letter to MNKD. Multiple sources (MNKD, patients, doctors, anonymous posters) have noted the need for better on-boarding and titration. Some suggest an app, and some suggest a more expedient and practical handout. As an initial attempt, doctors and patients could share a template of such an Afrezza Manual, or Lessons Learned, for doctors to customize for their patient's needs. Using a Creative Commons license, or similar, could allow this document to evolve in the public domain to help doctors and diabetics alike through an open and shared medium. With increased hyperlinks and quality connections, its Google PageRank could increase as source material that doctors could customize for their own HIPAA compliant web sites and so forth... creativecommons.org/ |
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Post by mbseeking on May 16, 2016 18:25:38 GMT -5
Even Afrezza's most zealous advocates state that they had to figure out how to use Afrezza during the first few days/weeks. I wonder if it's possible for an Afrezza App to be created that would help in this process. Each diabetic is different, so I think that having an App where you could "plug in" key data and it would give you dosing recommendations would be fantastic.
I suppose the FDA might want to have a say, though... If you abstract your thought , quite a bit, I believe this is what Castagna is trying to do. First they now have titration kit. A grab bag to select different shots from to get titration right. Second , nurse educators. This is the 'app' equivalent. These are the people working with new patients after the endo visit, especially the first few weeks of going onto Afrezza. Now they will be armed with info and tools to get the titration correct. |
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Post by dreamboatcruise on May 16, 2016 19:33:58 GMT -5
Even Afrezza's most zealous advocates state that they had to figure out how to use Afrezza during the first few days/weeks. I wonder if it's possible for an Afrezza App to be created that would help in this process. Each diabetic is different, so I think that having an App where you could "plug in" key data and it would give you dosing recommendations would be fantastic.
I suppose the FDA might want to have a say, though... Yes, therein lies the regulatory rub. Likely position of FDA... Better to have patients blindly making mistakes rather than risk mistaken guidance. |
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Post by slugworth008 on May 16, 2016 19:38:27 GMT -5
Good ideas. MattB wanted to create the HOWTO Afrezza Manual after he figured things out with his testing and endo. Need to ping him on that and if he needs more funding. Also, should try to make it into a template for doctors to download from Just Breathe... Long-term an app with a NIR spectrometer could calculate the correct dosage amount and timing. If the handheld spectrometer works well enough, this app could be accomplished within the year for a dedicated team. mnkd.proboards.com/post/67458/threadI doubt doctors would visit someone's personal website for instructions on giving a drug that can kill if given wrong (or any drug for that matter). They won't need to visit someone's personal website chief - I'm quite sure MNKD will provide a site with instructions and guidelines for dosing adjustments. Not that tough to do and probably already either done or being worked on IMO. |
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Post by agedhippie on May 16, 2016 19:57:06 GMT -5
Even Afrezza's most zealous advocates state that they had to figure out how to use Afrezza during the first few days/weeks. I wonder if it's possible for an Afrezza App to be created that would help in this process. Each diabetic is different, so I think that having an App where you could "plug in" key data and it would give you dosing recommendations would be fantastic.
I suppose the FDA might want to have a say, though... Yes, therein lies the regulatory rub. Likely position of FDA... Better to have patients blindly making mistakes rather than risk mistaken guidance. A small rant about the FDA and bolus advisors.... In the rest of the world many meters have a function built in that tracks the carbs you eat and your insulin onboard, and advises you on how much insulin to take. In the US, with one exception, this functionality is always disabled because trying to get it approved by the FDA takes so long. In the one case where it is approved, the Accu-Chek Aviva Expert, you have to be trained before they will enable that functionality. It's incredibly simple to use but the FDA approval makes it subject to training. In the rest of the world people just use it... There is a liability risk in providing medical devices without FDA approval. |
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Post by dreamboatcruise on May 17, 2016 13:05:54 GMT -5
Yes, therein lies the regulatory rub. Likely position of FDA... Better to have patients blindly making mistakes rather than risk mistaken guidance. A small rant about the FDA and bolus advisors.... In the rest of the world many meters have a function built in that tracks the carbs you eat and your insulin onboard, and advises you on how much insulin to take. In the US, with one exception, this functionality is always disabled because trying to get it approved by the FDA takes so long. In the one case where it is approved, the Accu-Chek Aviva Expert, you have to be trained before they will enable that functionality. It's incredibly simple to use but the FDA approval makes it subject to training. In the rest of the world people just use it... There is a liability risk in providing medical devices without FDA approval. We may have Pres Trump a year from now. Perhaps assuming Americans need training (and blunt scissors) is a good idea  Ooops... don't tell the moderators I said that. |
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