It’s a tricky balance with kids—the possibility of longterm effects is a lot scarier, since they have a lot longer they need their bodies to last. And yeah, you just can’t possibly know about that until you observe users of the product for decades. That said, we give kids plenty of products without that level of safety-testing all the time—I think questions that will factor into pediatric endo comfort level down the line might be a.) does the benefit outweigh the potential longterm risk (so if it offers a rather small benefit in control or ease of management, maybe not, but if the benefit is very large, maybe it does, especially since worse control is a very clear risk), and b.) how much will the product be used (having it on hand for occasional use vs as a regular bolus insulin).
I would’ve thought the study needed to be longer too. At least a few years. I clearly don’t know all the science behind it though.
I noticed that the pediatric trial includes the following outcome measure
- Assessment of fumaryl diketopiperazine (FDKP) elimination half-life (t1/2)
It looks like similar assessments were done in 2010 (I know that’s old…maybe there’s something newer):
I wonder if they’re thinking that this assessment somehow shows a level of safety?
Looking back through my 50 year history of multiple tools, products and techniques for controlling blood glucose, almost all of them were used before they had “long term studies” that some deemed necessary to prove safety in “their” eyes. All the while, I was living minute by minute with rudimentary tools and advice. I wonder where I would be now if I followed the conservative views requiring decades of studies to prove safety or to lessen a companies liability. The most current being dosing directly from our cgm results. And I am currently practicing “unapproved” sensor re-starts and dividing of Afrezza cartridges to give me more dose options which I’m sure is ■■■■■■■ someone off somewhere.
In my life, my health decisions are made by weighing the benefit vs possible danger in some obscure group or physicians minds or labs.
Again, meanwhile I’m living minute by minute with the real NOT perceived danger of this disease. I want to decide which risk I’m willing to take.
As of now, there is no technique or product that has come close to meeting my need for a truly immediate acting insulin with short duration. Nothing. Period. Attempts at filling this missing link is as humorous as the “5-year cure” we are all still waiting for. Because of those reasons. I choose to use Afrezza with no hesitation or decades of studies and red tape approvals.
I wish I didn’t need to qualify my comment by saying this is my experience and my personal decision process. Pediatrics is a whole other discussion that I’m not informed enough to comment on. I’ll gladly be used as a case study after my hopefully many years of use 
wow that’s the first time I’ve been censored on social media 
Yeah I have a long history of strongly advocating for afrezza and have been astounded by the negative responses I’ve received… to the point that I had become very defensive of anything but positive comments about it… to the point that it was a primary contributing factor to me being banned from another forum. The people who’s lives have been improved by it, including me, are very defensive of it… which ultimately leads back to it being from a small company producing it which created an absolute $hitstorm of small potato stock market short sellers going online to attempt to spread fear and misinformation about it—- the seeds they planted have spread far and wide. I have zero concerns about its safety and love the freedom and quality of life it’s allowed me.
Sorry about the censor, but really it is just a swear words list that we created since we have younger members. Also you should know that it is a really simple list, i.e. compound words needed to be added one by one to get to a reasonable list. My wife and I laughed our butts off as we created the list to “censor” you.
Well that explains a lot , @Sam. I am not surprised. I ran into that while I was trying to obtain my scripts etc but fortunately I have a very supportive doctor, educator and MannKind worked for me. That really supports my feelings when I was writing my comment. It’s too bad. I haven’t found too much backlash (some) from most fellow T1’s but I’m surprised by the closed minded way that some cling to what they know. It takes a very open mind to a new way of thinking. That’s tough for some of us old timers lol. But as I’ve gotten older my body has totally changed in how I treat T1 and I need new tools.
Until I saw the impact on my control, I didn’t realize how much it means to have an insulin that works more like a healthy pancreas works. And again I want to thank all of you who helped me.
I knew that @Chris and I thought it was funny. At first I wasn’t sure what I said haha. It was so G-rated for my potty mouth.
Yes it certainly requires an open mind regarding how the dosing works… it was drilled into us all that x units insulin = y grams carbohydrates, but that’s an unbelievably overly simplistic concept that was created many years ago to allow for the tremendous technological shortcomings of the insulins that were available at the time… so I understand and can relate to those who are skeptical. What I really hate though is that a huge contingent of wanna be profiteer penny stock investors took to the internet and tried to capitalize on those very deep seated fears of people who depend on getting their insulin right in order to live… and I hate that they were so successful… in convincing people that this is a bad idea, that it’s controversial, that it’s risky…
The reality is that it’s revolutionary, but currently we live in a world where anyone can get online and have a platform to spread whatever fear they want… and those things take root—- perfect example—- the fda expert committee never recommended the black box warning or counter indications? Where did they come from???
Internet hysteria spawned by penny stock short sellers and strong arm tactics from their powerful competitors. Shameful…
@Sam - I’m with you and @Jattzl on this one. Despite having pulmonary issues, I’d jump at the chance to use Afrezza if and when it becomes available in Canada.
Whether of not you choose to use Afrezza is a simple choice, one which educated consumers should be allowed to make without the bias of their doctor.
I think Afrezza is something that belongs in everybody’s toolkit for treating hyperglycemia, whether for carb miscounts, splurges, growth spurts, illness, etc. More options means more time in range, IMHO.
Yes, I can relate also. I really needed help with the ingrained training and learning a new way.
T1’s resistance almost always is towards the effect on their lungs. Your explanation of what was done never occurred to me and makes perfect sense. It makes me sick. I’m disgusted but it . Shameful is not strong enough of a word.
I don’t know if it will help but I feel like if the word is spread as much as possible we can be a pretty powerful force because we feel so passionately about our disease. So I hope that the more people try it and are exposed to it the better.
I’m trying to do my part. The rep came to speak at a meeting I attend and everyone was very receptive to it. He also came with me to doctors offices so that hopefully they will offer it to their patients. My educator has also met with him to helps others start.
I can’t get over this. It infuriates me. (■■■■■■ me off )
Rightfully so… should infuriate everyone… but apparently that’s the way the game is played in pharma when a small player invents a revolutionary treatment
I think that’s a great attitude to have but it also requires doctors to prescribe things for you! Pediatric patients will have a very tough time finding anyone willing to write a script for it at this time… I have not heard of anyone under 18 successfully getting one, honestly.
I do hope it changes because, although I would not want my child to be the first, I certainly would love it if there were some additional information on its safety in a pediatric population.
I have asthma and was initially sceptical of Afrezza, but after reading about it for several years, I’d ask for a prescription for it immediately if it comes to Canada. Not sure any doctor would prescribe it, but I bet my endocrinologist would if I told him I’d only plan to use it for correcting occasional higher highs (like >13 mmol/L) and that I’d monitor myself closely and discontinue use if I noticed any sort of asthma/allergy issues.
I’m curious. For people who are in Canada. Isn’t there a way to order directly from company? Like, I know people go to Mexico for insulin or order online from Canada for cheaper prices. I don’t know how it works but it seems like you should be able
to order it if you can get a script???
There are only a couple of limited conditions under which physicians in Canada are allowed to prescribe a drug that hasn’t yet been approved here. Americans going to Mexico or ordering insulin from Canada is a bit different: the same insulin is already for sale in the US, just for a higher price.
For me, Afrezza is maybe the most exciting thing to come along in several decades. I have mild asthma, so if Canadian approval carries warnings about pulmonary function, I expect my endo to say no. In which case I will go looking for a new endo, it’s that important to me.
I’m with you on this brother. I have pulmonary hypertension, and I know several of the 1/2 dozen docs I have would likely refuse to write me a script for Afrezza.
I’m just afraid the Health Canada might take another few years to approve Mannkind’s application 
Well I hope the Canadian system isn’t as corrupt as the USA’s then. In my opinion, and I followed it closely (and my opinion doesn’t differ from the FDA’s expert advisors) there was never any reason for the counter indications…
I consider that pure corporate sabotage. Imagine how much more excitedly it would have been received, prescribed, and accepted without that? And there was no reason for it…