Simple. No protocols!
When you read all the articles about the “head to head” competition between Afrezza and current insulin treatments in the drug trial, and the result is simply “non-inferior”, what should someone make of it? I’d like to chime in and add my “real-world” experience being both in the drug trial and now afterwards without having to follow all the protocols. After all, would you take advice from someone who has actually used the drug in “real life” for over 6 months or someone who simply saw a photo of the drug and read some parts of a report that the drug is non-inferior to another drug? For this comparative perspective, let’s say they were both automobiles. Yes, they both have wheels, an engine, seats and are used for travel and with both you will reach your destination-this is what I consider the drug trial to have proven (that both types of insulin work). However, in this example, what you don’t realize is that you are actually comparing a Ferrari to an old pickup truck—and the Ferrari was not measured to demonstrate it’s superiority in handling, speed, comfort and driver satisfaction.
The first thing that comes to mind for me is that the trial #’s never told the whole story. This is so evident now that I can visually see how verifiably Afrezza mimics the human pancreas. In the drug trials we all wore a CGM (continuous glucose monitor) for a week or so, but we could never see what the numbers were or how we were doing (ie. because the output of the device was completely disabled from being viewed). As many of you who follow me on twitter know, I am always “in zone” over 85% of the time now without much effort, because of practice/experience using Afrezza along with the knowledge of how the doses will affect my body (ie. how much my BG will drop when I use Afrezza and for how long).
Recently, another new afrezza user, who posted on Twitter wrote “Took 4 units Afrezza. BG 128 at 8:12am. I predict it will drop to around 85 then be done. Let’s see”, then later “BG 87 exactly as predicted”. His result confirms what I have been posting online for over 3 years. That with Afrezza, diabetics will have faster, smoother and more reliable control than current injectable insulins on the market like they have never experienced before.
On my twitter account (@afrezzauser) I talk often of how I am adjusting my doses slightly depending on so many factors. As a diabetic we need to be more flexible because our insulin needs change according to our level of physical activity, sleep, mood, stress, diet, schedule, fatigue, etc. However, on the trials our doses could only be adjusted to stay on “protocol” and therefore was only done every 4-6 weeks when we had our office appointments. I can see the point of doing that for the sake of “uniformity”, however with this new drug, there was concern I was improving too much and risked having hypoglycemic “lows” before the next checkup (at this time my A1C measure was a 6.8 and getting lower with each successive test). Thus, my dosage was lowered. My current experience suggests it was unnecessary to do but at the time was done to make sure I didn’t have any severe “lows”. You can verify, but I believe there was one patient in the trials who had over ½ of the total lows and he was someone who was taking additional diabetic medications, which really skewed and screwed up the overall results. Can I blame my doctor or the trial setup for not making my performance better? No. my doctor was being diligent, following all guidelines and being careful because this was a new drug that definitely doesn’t work like the “old” insulin most people are used to. It was never meant to be the occasion where we all could learn to “dial it in” and directly track our progress—it was only to show it worked. Every diabetic is unique, but from results I am hearing from users currently on Afrezza now, we all seem to experience even greater and more improved results, far surpassing those from the trials as you would expect. From my own journal, my final A1C on the trials was a 7.1 and now it will be most likely be in the high 5’s when I reach the 3 month mark to have an official test done at my doctors office. When I reveal what my A1C number was before I got back on Afrezza, you will be shocked at how well I am doing. No drug ever worked this well, and many others will be saying the same thing very soon.
The overriding measure of diabetic health is currently A1C, but to me the more important measure to not do damage to your body should be the measure of “time spent in zone”. For example in the trials, both a person on Afrezza and a person taking the “other” insulin can have an average blood sugar of 150 but I can tell you that the Afrezza patient would stay in range between 100 to 200 while the other patient will be 50 to 250. Thus, they would have the same A1C, however avoiding those “higher highs and lower lows” is much more beneficial for any diabetic, and does less long-term damage to their body. Yes, the trials were not setup to prove this and to demonstrate the biggest and best strengths of this drug, (ie. fast 15 minute “peak action” and no 4 hour “tail ends”). In a way, it was like saying both cars did 3 laps a day for the six months and so both in that regard are “non-inferior” which is statistically true. The interesting observation will be how many ever go back to taking their “old insulin”? My guess is no one will ever want to go back— what would the advantage be?
In the future, if ever there was a test between 10 experienced Current Insulin users vs 10 experienced Afrezza users and the protocol was to do your best in managing your diabetes (for 1,2,3,6 or however many months) and tell us about your life before and after —I know the Current Insulin team wouldn’t stand a chance of winning in head to head competition against Afrezza. And I do mean this very seriously. In the trial, our data counted from day 1 and we competed against longtime Insulin users who knew what they were doing having years of experience. On the other hand, Afrezza was brand new, and we had limited instructions as to how to best utilize this medication and how it would work. We were all told “at the beginning of the meal” and that connotation is subject to varying degrees of interpretation for everyone. How could you expect great results when the Afrezza team was just learning how to “dial it in” and having to take baby steps with not much feedback or others experience to help you? From my current process, I know that for me when I check my blood sugar and if I’m over 120, then I’ll take Afrezza once I begin eating, but if I’m under that number, then I’ll wait for 15 minutes or so before I take my first dose. In addition, if it’s a really big meal, I’ll take a second dose an hour or so later. By the way, a dose takes literally seconds vs. very long prep time for an insulin pen, and you can see that clearly in many internet videos demonstrating this (Google search “Youtube Afrezza vs. Insulin). And I can make several corrections if needed versus my prior treatments. I’ve used that longtime old treatment “regimen” so I know what I’m talking about. Even if I did my very best of my ability, there is no way I could ever approach the results I am having on Afrezza. Never. Right now, Afrezza is just scratching the surface (107 new Rx’s last week), but when more people come forward the tide will change quickly and more and more people will experience the same freedom to get off the “dizzying” old insulin rollercoaster that I have (and many, many others soon to follow).
The peace of mind I am feeling having Afrezza inhaled insulin is beyond description. Afrezza has helped me to have less stress, less anxiety, and also sleep better since I’m not up all the time waiting to make sure my sugar levels are in range—leading to a much higher quality of life living as a diabetic than I ever had before. And all you have to do is look at my charts before and after Afrezza to see the qualitative and quantitative evidence. But you’ll never read about any of that in the drug study-it was not measured. And that has allowed many naysayers to attack. Frankly, I question their ulterior motives knowing that thousands of lives every year could be saved and their life quality improved by this new and exciting treatment option for diabetics. The FDA was overwhelming correct to approve Afrezza. It even should have been done years earlier because the magic isn’t the inhaler device even though it is superb—it is the drug—Afrezza that makes this a life changer! Now go test drive that “Ferrari” and see if it works for you as well as it did for me.