I hope by describing our family’s experience with Afrezza, that other diabetics will be able to anticipate the challenges we faced in acquiring and using it. But first I want to thank all the users and advocates that enabled us to get an Afrezza prescription for our 17 year old type 1 diabetic son. I won’t take the space to thank you all by name. I am referring to the online twitter community that tweets using the #Afrezza hashtag. I know these pioneers and patient advocates also post on other social media and advise anyone interested to seek them out.
First I point out that twitter accounts intended to slam Afrezza and its stock do far more damage than should be permitted. These people both directly and indirectly harm type 1 diabetics and their accounts should be blocked as soon as their comments cross the line into harassment. Those using social media to learn more about Afrezza and prescribers beware these “trolls”. Do not feed them but keep a close eye on their antics and transgressions. The SEC will hopefully do its part at some point as much of this harassment seems intended to abet short selling of MNKD on the stock market.
Second essential point: Don’t take no for an answer if your endocrinologist or GP denies you Afrezza. This is not the middle ages. A blood glucose tool for the third millennium exists but is being kept from pastients by a medical and business establishment that has no clue of the psychological and physical harm that is done to diabetics by preventing them from learning about and relying on Afrezza to treat their diabetes. It is a game changer.
Granted there are problems and idiosyncrasies that also limit adoption of this new treatment paradigm. But lets be realistic: the standard of care and treatment of diabetes will not improve if diabetics accept as given the psychological and physical toll this disease exacts as they must strike a bargain between glucose control and a tolerable quality of life. I have already seen the trend to favor a less stressful life of lowered blood glucose control expectations developing in my son despite our best efforts to how him how optimum control is possible.
All diabetics using the current injectable therapy, that remains the standard of care, must strike this very personal balance; and, the individual choices, some tragic, point out the true dimensions of this disease and its treatment. Access to Afrezza or any other therapies for diabetes must be personalized to match the psychological as well as physiological dimensions of this ravaging condition. It is not and should not and shall not be left to the comfort zone of physicians, HMOs, Insurance companies or investors in pharmaceutical companies. Why should we expect all diabetics to live the same lifestyle, eat the same diet and tolerate the same risks? New tools have been created which allow them to manage their own risks and choose how they will live with the limitations enforced upon them by diabetes. Why should they also have to live with the limitations impose upon them by physicians, HMOs, Insurance companies or investors in pharmaceutical companies?
My son has barely used Afrezza for 1 month. It has already immeasurably changed his and our family’s life with diabetes- though it is too soon to report an A1C change. Concurrent with his switch to Afrezza we have been dealing the end of a long (he was fortunate) “diabetes honeymoon” which we were somewhat unprepared for. As we were adjusting to Afrezza we were also adjusting his Lantus (basal insulin) from once up to twice daily injections a day and from 17 units/day to 21/day. In many ways Afrezza helped us understand how his humaog bolus at meals was masking the increasingly insufficient basal coverage. With Afrezza, as the basal dosing increased he has been able to flat line in the night like he did during his long honeymoon (he was fortunate).
As his prandial insulin, we immediately noticed that Afrezza is very fast. He never spikes at the beginning of a meal when using Afrezza. His time in range is markedly improved. And meals out and snacks are no longer full of anxiety over how to cover and measure carbs for his insulin shot. Taking the shot in a crowded restaurant was itself a huge buzzkill.
He has gone low on Afrezza but rarely. He reports the low feels nothing like the desperate and long drawn out episodes he feels on Humalog. And this is confirmed by CGM traces that show lows are shallow and brief. As we better understand how to use Afrezza (don’t take a dose if you are at 69-wait till you are over 100) we know lows will be even less common. Generally he has no problems exercising with Afrezza, even right after a meal. We notice that Afrezza seems to lower blood sugar with exercise much more reliably, effectively and safely than Humalog.
I have posted some CGM traces on Twitter but confess my son is not a consistent user of his CGM. I wish I could get more data public but I cannot force him to do this. We have found however that one can use a clock almost as well as a CGM or fingerstick in timing Afrezza doses. The trick is in understanding how a pancreas would handle a meal. I am not advising this approach but being pragmatic for our situation.
My son is alas a teenager. Since getting Afrezza we have allowed him to eat and manage his own care like never before. This means he eats a lot of carbs at all different times of the day. This is not an ideal situation, even with Afrezza, since he often forgets to check on whether he needs follow up doses. Effectively, our family has lowered our expectations of better blood sugar control and time on CGM in order to allow my son to be free to eat and behave as teenagers will. We rely on Afrezza’s superior PK/PD to make the trade off of control for freedom a net neutral for his blood sugar control, which, was already pretty good (A1C in low to mid 6s). We note that in the month since starting Afrezza our son has grown almost an inch- the most he has ever grown in such a short time AND WE THOUGHT HE WAS DONE GROWING.
But it hasn’t all been footloose and fancy free. It has taken a while to get the prescription right. Whether the FDA label or newness of the product, standard packaging of dose counts has been hard to figure out. And we have already changed the rx form its original package. If Afrezza were an off shelf medicine it would be so much easier to tailor dosing and amounts for individual and family diet. Why the heck can’t insulin be sold from the aisles? Its not like we ever check with the clinic when dosing for a meal. Is this about insurance and the HMO practicing medicine?
Because of the “titration” and Rx package changes we have had two gaps of over three days without Afrezza. My son had to fill in with Humalog - which made us appreciate Afrezza all the more. It took us a while to understand that our son needs more Afrezza because he wants to eat like a teenager. A “standard” Afrezza pack would be enough for the diet appropriate to my condition and age. My son needs more – which is also more expensive. That is the other problem we have. My son’s Rx is off-label since he is a year shy of 18. We have to pay cash since our insurance won’t RX, won’t cover and the company coupons are not valid for minors. I don’t want to bash the company, it is struggling enough just to make Afrezza available to diabetics. HMO price and insurance coverage are outside the companies hands. But if there is one reason Afrezza use is not more widespread, price may be a bigger factor than may be appreciated.
It also took us a while to realize how much more Afrezza is needed to bring down a high than using Humalog for corrections. It’s a little intimidating to take 8units to bring him down from a high of 200. It is also more important, therefore, to stay on top of glucose rises after the many high carb meals he eats since going out of range requires so much more Afrezza to correct. He is slowly adjusting to the fact that he cannot just forget about his blood sugar just because he does not see a spike immediately after eating with Afrezza. Big carb meals will need follow up doses.
I sometimes wonder whether an alternative formulation of Afrezza that mixes in a little of the longer lasting analogue hexameric insulin (like Exubera?), along with the majority portion of first phase human insulin currently used, might make titration a little easier. Lengthening the second phase activity might decrease the need for more follow ups and corrections. It might also increase hypos, but perhaps a happy medium could be found? I realize this would require more FDA trials and more $ but, come on, shouldn’y we try to perfect this to give diabetics the best quality of life and lenght of life they can have? Isn’t that what the new 21st century cures act is supposed to expedite? Why shouldn’t Afrezza be the first test of this initiative?
We have managed to get past the learning curve and I know my son will never willingly go back to injected prandial insulin as long as Afrezza is available. However, I wonder if more should be done for less activist diabetics and their parents. I suspect the barrier for some patients is identical to the barrier encountered in the endocrinologist’s office. Afrezza works like pancreatic insulin, but how many pateints and endocrinoligists really understand how an individual’s pancreas would act (WWMPD?) with a given meal, how many times would it fire? Does the body’s insulin degrading enzyme act more readily on monomeric human insulin than hexameric analogues? Is there an efficiency threshold for Afrezza dosing beyond which degradation mimics insulin resistance? Is that why corrections are more demanding on Afrezza and hypos less frequent? It would be nice to have answers to these and other questions for prospective Afrezza users and prescribers.
In spite of his difficulties with transitioning to Afrezza and this new version of “compliance” we have noticed our son is much more involved in titrating and planning for his meals. This is no doubt due to the fact that meals with Afrezza can be spontaneous (you can inhale right as or a little after you eat) and that you don’t so much titrate aliquots of medicine as fire up the inhaler as if it was an external pancreas. In short, his experience with Afrezza has also made him more responsible with the old injectable regimen - when we have had to revert to it (and should he ever need to go back to liquid insulin). Somewhat unexpectedly, Afrezza is definitely helping with the independence project. And as the experts know, the transition to adulthood is one of the hardest and most dangerous times for type 1 diabetics diagnosed as juveniles to navigate.