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Post by rickf on Sept 22, 2017 15:51:48 GMT -5
I have NO idea if this is even possible but --- I wonder what would happen if we all kicked in $$ directly to Mannkind so that they could donate badly needed Afrezza (insulin) to the impacted countries --- the ones that can legally use Afrezza that is. This would do many things good and promote the benefits of Afrezza at the same time?
Just trying to think out of the box!
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Post by sayhey24 on Sept 22, 2017 17:36:13 GMT -5
Puerto Rico is a huge mess. This is a disaster of mass proportion effecting 3.4M people. PR government officials are predicting electricity not be restored for months. The Telegraph is reporting Carmen Yulín Cruz, Mayor of the capital San Juan, said: "The San Juan that we knew yesterday is no longer there. We're looking at four to six months without electricity." www.telegraph.co.uk/news/2017/09/21/puerto-rico-faces-months-without-electricity-wake-hurricane/Based on some general estimates assuming 0.3% of the population is T1 and 2% of the population is insulin dependent T2 over 78,000 people are in serious trouble. At the same time we are also talking about using afrezza as not just a mealtime insulin which it is labeled for but also to substitute for their basal which may take another 3 or 4 cartridges per day. What we are talking about is a minimum 300 cartridges per PWD or about 23.5M cartridges per month or roughly 260,000 90ct boxes per month. They will need atleast a four month supply. This is going to take a major Federal government buy and would require MNKD to fire-up equipment which has not been used in years. The good news is Mannkind is already on the VA schedule from which FEMA or another government agency could buy from. The biggest issue is the "approved label". We know afrezza is stable over 2 years without refrigeration but that is not on the label. afrezza is also labelled for prandial use and we are talking about mimicing basal need by puffing small cartridges 3 or 4 more times during the day. We also have the spirometry requirement and COPD warning which need to be ignored. I have been told an emergency label can be approved by the FDA in days. Who knew? Some afrezza advantages are clearly no need to refrigerate, reduced hypo risk, ease of use and no need to dispose of sharps which is another issue in this disaster. |
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Post by agedhippie on Sept 22, 2017 19:52:08 GMT -5
Puerto Rico is a huge mess. This is a disaster of mass proportion effecting 3.4M people. PR government officials are predicting electricity not be restored for months. The Telegraph is reporting Carmen Yulín Cruz, Mayor of the capital San Juan, said: "The San Juan that we knew yesterday is no longer there. We're looking at four to six months without electricity." www.telegraph.co.uk/news/2017/09/21/puerto-rico-faces-months-without-electricity-wake-hurricane/Based on some general estimates assuming 0.3% of the population is T1 and 2% of the population is insulin dependent T2 over 78,000 people are in serious trouble. At the same time we are also talking about using afrezza as not just a mealtime insulin which it is labeled for but also to substitute for their basal which may take another 3 or 4 cartridges per day. What we are talking about is a minimum 300 cartridges per PWD or about 23.5M cartridges per month or roughly 260,000 90ct boxes per month. They will need atleast a four month supply. This is going to take a major Federal government buy and would require MNKD to fire-up equipment which has not been used in years. The good news is Mannkind is already on the VA schedule from which FEMA or another government agency could buy from. The biggest issue is the "approved label". We know afrezza is stable over 2 years without refrigeration but that is not on the label. afrezza is also labelled for prandial use and we are talking about mimicing basal need by puffing small cartridges 3 or 4 more times during the day. We also have the spirometry requirement and COPD warning which need to be ignored. I have been told an emergency label can be approved by the FDA in days. Who knew? Some afrezza advantages are clearly no need to refrigerate, reduced hypo risk, ease of use and no need to dispose of sharps which is another issue in this disaster. You would need to take Afrezza every two hours in order to replace basal insulin so you are either not sleeping for the next few months or going into DKA and possibly dying. There is a reason basal insulin is designed as a long slow burn and that people like Tresiba because it lasts longer than Lantus. Modern insulin lasts a month without refrigeration so there is no rush. Sharp disposal is no more of a problem than it ever was - you either clip the needle (old school), or use the plastic cap specifically designed to shield the used needle. This is not FEMA's first rodeo, they know what they are doing and how to manage insulin, so no it's not an Afrezza sales bonanza (words fail me) |
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Post by rickf on Sept 23, 2017 7:09:51 GMT -5
Appreciate the response - I was kind of thinking that Mannkind would be able to "donate" Afrezza to the disaster hit countries if they were able to receive some remuneration to offset their costs a bit from - say us - that way, they would perhaps get some huge "free" press for their gesture as well as possibly help out a lot of folks that maybe need the help.
Just trying to find a win-win!
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Post by derek2 on Sept 23, 2017 9:58:39 GMT -5
******* Wet blanket warning ******* Afrezza is anecdotally claimed by some to be stable at room temperature. MNKD, however, ran a 2-year stability study, and measured the rate of decomposition at room temperature. Based upon this 2-year study, MNKD and the FDA agreed on refrigeration requirements that are stricter than modern SC insulins. Who to believe... anecdote (including Al speaking off the cuff before the label was agreed to, or the company, their chemista and FDA chemists. Remember - the company makes no undertaking to correct anything that they say on conference calls or in interviews, BUT the label is a correction by the company, and they have not claimed room temperature stability since then. Thus, the position of the company is that Afrezza requires refrigeration and is only acceptably stable for 10 days at room temperature. Those that claim stability after "hold my beer and watch this" experiments have no idea of the chemical changes in the insulin they're inhaling. www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472Orig1s000ChemR.pdf[EDIT] Not trying to deny disaster victims life saving medication. Those decisions are made away from anything that's said on this message board. Just trying to give a rational point of view of where and why the label says what it does, as opposed to wishful, or wistful thinking. |
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Post by ghochr on Sept 23, 2017 10:19:06 GMT -5
But derek2Let's be clear—Afrezza has absolutely nothing in common with any other exogenous insulin other than it is used for PWD. Afrezza is the only insulin in the world that mimics endogenous prandial insulin secrection like that of a healthy nondiabetic, it is the only insulin formulation in the world made that is delivered in a stabilized monomeric form loaded onto a particle matrix, it is the only inhaled insulin in the world, it is the only prandial insulin in the world that mimics the first phase insulin response, it is the only insulin in the world that does not cause localized insulin-derived amyloidosis, and it is the only damn insulin in the world that can restore glucose homeostasis. Read more: mnkd.proboards.com/thread/8520/label-change?page=9#ixzz4tW1hMqoL |
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Post by sayhey24 on Sept 23, 2017 10:53:03 GMT -5
Derek - I had the opportunity to talk directly with the QA people who did the evaluations. They told me publicly they would be willing to say 3 months no-refrigeration. Unofficially, they said it would stay highly stable for over 2 years.
I am not sure what the discussion of the cartridge is. The cartridge is sealed in a foil bubble container. I suspect the discussion may have been once out of the sealed packaging.
Regardless, Puerto Rico might be the worst disaster the U.S. has even seen. Unlike Harvey and Irma were we can drive lineman and supplies to it PR is air and boat. For Irma we had convoys headed down I95 from the NE days prior and they staged ready to go in right after. PR right now is worse than a war zone. Kurt Schilling may be running the most effective operation right now with his special ops guys.
One thing I was looking for was the lady who was an early afrezza user. In the write-up she said she was a T1 who had been on a pump for many years, then went afrezza/basal but is now only using afrezza. I thought her name was Terry but I can't locate the article.
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Post by derek2 on Sept 23, 2017 10:57:33 GMT -5
But derek2 Let's be clear—Afrezza has absolutely nothing in common with any other exogenous insulin other than it is used for PWD. Afrezza is the only insulin in the world that mimics endogenous prandial insulin secrection like that of a healthy nondiabetic, it is the only insulin formulation in the world made that is delivered in a stabilized monomeric form loaded onto a particle matrix, it is the only inhaled insulin in the world, it is the only prandial insulin in the world that mimics the first phase insulin response, it is the only insulin in the world that does not cause localized insulin-derived amyloidosis, and it is the only damn insulin in the world that can restore glucose homeostasis. Read more: mnkd.proboards.com/thread/8520/label-change?page=9#ixzz4tW1hMqoLFine. Nothing in your statement addresses room temperature stability, which would make it a great match for disaster areas. |
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Post by derek2 on Sept 23, 2017 11:01:51 GMT -5
You know what I'd love? A label change showing superior stability. The label = the company telling you what has been proven, and the FDA agreeing. I'd do the Michigan J. Frog dance over that.  |
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Post by ghochr on Sept 23, 2017 11:05:27 GMT -5
But derek2 Let's be clear—Afrezza has absolutely nothing in common with any other exogenous insulin other than it is used for PWD. Afrezza is the only insulin in the world that mimics endogenous prandial insulin secrection like that of a healthy nondiabetic, it is the only insulin formulation in the world made that is delivered in a stabilized monomeric form loaded onto a particle matrix, it is the only inhaled insulin in the world, it is the only prandial insulin in the world that mimics the first phase insulin response, it is the only insulin in the world that does not cause localized insulin-derived amyloidosis, and it is the only damn insulin in the world that can restore glucose homeostasis. Read more: mnkd.proboards.com/thread/8520/label-change?page=9#ixzz4tW1hMqoLFine. Nothing in your statement addresses room temperature stability, which would make it a great match for disaster areas. Pardon me Sir . I forgot to plug in 😜 While quoting Mango |
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Post by derek2 on Sept 23, 2017 11:22:11 GMT -5
Fine. Nothing in your statement addresses room temperature stability, which would make it a great match for disaster areas. Pardon me Sir . I forgot to plug in 😜 While quoting Mango LOL. I should have been less terse, I guess. No disrespect or high-handedness was intended.  |
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Post by agedhippie on Sept 23, 2017 19:29:41 GMT -5
One thing I was looking for was the lady who was an early afrezza user. In the write-up she said she was a T1 who had been on a pump for many years, then went afrezza/basal but is now only using afrezza. I thought her name was Terry but I can't locate the article. If she could give up basal I would suspect that she is a misdiagnosed Type 2 which does happen. There was a point at which if you were in DKA they automatically classed you as Type 1, subsequently they started doing antibody checks and discovered a whole class of Type 2 they never knew existed! |
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Post by itellthefuture777 on Sept 23, 2017 22:22:03 GMT -5
From FDA website Insulin Storage in an Emergency It is recommended that insulin be stored in a refrigerator at approximately 36°F to 46°F. Unopened and stored in this manner, these products maintain potency until the expiration date on the package. Insulin products contained in vials or cartridges supplied by the manufacturers (opened or unopened) may be left unrefrigerated at a temperature between 59°F and 86°F for up to 28 days. Insulin loses some effectiveness when exposed to extreme temperatures. The longer the exposure to extreme temperatures, the less effective the insulin becomes. This can result in loss of blood glucose control over time. Under emergency conditions, you might still need to use insulin that has been stored above 86°F.You should try to keep insulin as cool as possible. If you are using ice, avoid freezing the insulin. Do not use insulin that has been frozen. Keep insulin away from direct heat and out of direct sunlight.When properly stored insulin becomes available again, the insulin vials that have been exposed to these extreme conditions should be discarded and replaced as soon as possible. For more information see Information Regarding Insulin Storage and Switching Between Products in an Emergency (en Español). www.fda.gov/newsevents/publichealthfocus/ucm317232.htm |
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Post by sportsrancho on Sept 23, 2017 22:37:53 GMT -5
One thing I was looking for was the lady who was an early afrezza user. In the write-up she said she was a T1 who had been on a pump for many years, then went afrezza/basal but is now only using afrezza. I thought her name was Terry but I can't locate the article. If she could give up basal I would suspect that she is a misdiagnosed Type 2 which does happen. There was a point at which if you were in DKA they automatically classed you as Type 1, subsequently they started doing antibody checks and discovered a whole class of Type 2 they never knew existed! I remember that lady too. I don't think she was from Twitter. Maybe FB blog? Compound might remember... |
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Post by brentie on Sept 24, 2017 1:53:23 GMT -5
If she could give up basal I would suspect that she is a misdiagnosed Type 2 which does happen. There was a point at which if you were in DKA they automatically classed you as Type 1, subsequently they started doing antibody checks and discovered a whole class of Type 2 they never knew existed! I remember that lady too. I don't think she was from Twitter. Maybe FB blog? Compound might remember... You may be thinking about MLG. mnkd.proboards.com/user/1034/recent |
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