|
Post by stevil on Jan 25, 2023 10:00:13 GMT -5
Agree, I am forced by insurance to save Afrezza until it’s too late. They don’t ever approve for newly diagnosed type 2s because insulin isn’t first step.
It does take a village to raise a person with diabetes. We have all those resources, but where it gets tricky is I don’t listen in on the education that my patients are getting. Most say the education is beneficial- if they even agree to do it- but there is still a huge learning curve. It’s much easier to manage the disease in the early stages and Afrezza is a lot more forgiving as well.
|
|
|
Post by stevil on Jan 25, 2023 8:10:36 GMT -5
There are black box warnings on many medications. You talk about them with the patient and make sure they’re informed. Thyroid cancer is still theoretical and hasn’t been proven in humans yet.
You watch them closely and examine their thyroid when you see them a couple times a year. Fortunately (unfortunately) you typically see people with diabetes at least 4 times a year to monitor labs.
I try not to put patients on Afrezza and other medications. So if they get insulin, they get a CGM and Afrezza only or Afrezza+basal if they need it. A wise man named Bill once told me that Afrezza is like Adele. You don’t drown out the voice of an angel by putting a bunch of background singers or an orchestra around her. You let her take front and center to allow her to shine. By the time people need insulin, it sort of becomes superfluous to have them on other agents unless you want to try to decrease their insulin doses.
Honestly, it depends on my patient and what they can handle. And this gets to the “good enough” argument. I talk to my patients and ask them how much they want to manage their disease and how much they want their disease managed by me and medications. If the patient is reliable and motivated, I equip them the best I can with the best tools I can. Then we check in to see how they’re doing. There have been numerous patients that are highly motivated at the beginning because they want to do better but once they realize how much work it takes to stay on top of their disease either fizzle out or let things slip through the cracks. Then we tweak their plan the next time to what they can manage.
So, for me, it’s usually individualized for each of my patients. I may sometimes start the patients I’m not comfortable with on orals/injections. Same if I get the sense they’re not going to do well on insulin (not from a hypoglycemia standpoint- I trust Bill when he says he has no meaningful hypos with Afrezza alone) but rather that they’ll not only dose 3 times a day but also monitor their dosing until they dial it in with either finger sticks or CGM. The real world is a lot harder than controlled studies, which is why I (and apparently insurance companies) have been following VDEX very closely and their model for success. You don’t find 80% retention/adherence in the diabetic space. The other part of the problem is it really does take a lot of time to explain dosing of insulin. Carb counting- I have not yet had the ability to dose Afrezza without it, physiological changes from illness/stress/exercise, food composition, etc, etc all play a role in glucose control. Maybe it’s the patients I select… they’re a lot further in their disease than VDEX or (and more likely) they know how to use Afrezza better, but the patients I have on Afrezza take upwards of 24-36 units of Afrezza with each meal and still sometimes struggle with mealtime control without basal insulin to help out. I have to meet with several of my Afrezza patients once 1-2 times a month until we get it figured out. It takes a lot of time to do this, not only for myself but my patients. Access becomes another dynamic you have to consider. Not many patients are able or want to see their doctor this often. So bringing it back to the “good enough” argument that has been had on this site many, many times. You do the best you can to set up your patients for success. If it comes down to running into the 200s on occasion and losing 5 years from their lives, it’s better than giving them a plan they can’t manage that will either make their sugars run 400+ because they’re neglecting them or kill them entirely if they’re not paying attention. I have one elderly woman that comes to mind. She injects 15 units of novolog with each meal. She refuses to check her blood sugar and won’t let me out her on a CGM. Her A1c is at a 9. I’m not touching that with a million foot pole. I’m not going to want better health for her than she wants for herself and she’s been doing this for 5 years. I don’t fight her. She’s still alive after 5 years. You take what you get…
|
|
|
Post by stevil on Jan 25, 2023 0:08:13 GMT -5
I have 2 patients I can recall from… it has to be closing in on at least 100 at this point… that have discontinued GLP-1s or Mounjaro. I’ve only gotten Mounjaro approved for 3 people so far but no one had more than just a very mild nausea that went away after the first day of injection and was completely gone after the first month, essentially the titration dose.
TIFWIW
|
|
|
Post by stevil on Jan 18, 2023 21:57:14 GMT -5
Seems like UTHR is pretty confident they’ll expand the label and I imagine they don’t think MNKD will be able to keep up with future production once it does
|
|
|
Post by stevil on Jan 3, 2023 16:42:01 GMT -5
then expect a substantial thrust to continue after a pause and shallow retracement at the end. Watch your language this early in the morning... Sexual innuendo…
|
|
|
Post by stevil on Dec 15, 2022 2:22:08 GMT -5
|
|
|
Post by stevil on Dec 15, 2022 2:18:19 GMT -5
Because I assume, perhaps incorrectly, it will require a ton of money and time and may not get approved for treating anything besides leprosy. I do have some insight on this one. Clofazimine is not being developed for leprosy. It's being developed for non tuberculosis mycobacteria (NTM) which is an extremely difficult lung infection to treat. The current cocktail includes 3 generic drugs, but you have to take them for years to even have a chance to cure the infection. All the while, you're exposing your body to the harmful effects of chronic antibiotic therapy and putting yourself at risk of losing efficacy of potentially entire classes of antibiotics by forming bacterial resistance. The market isn't huge, but it's open for the taking as there isn't a great solution currently available. I can easily see Mannkind going this one alone, assuming they have the capital to run the necessary trials to bring it to market and assuming the results are what we expect without any serious adverse effects to treatment.
|
|
|
Post by stevil on Dec 15, 2022 2:08:13 GMT -5
How big is the market for this TS Clofazimine? stevil wrote, Right now I'm holding because I have faith in UTHR and Tyvaso DPI and MNKD has some potentially lucrative prospects waiting in the wings that I want to see if anything materializes... Namely the clofazamine treatment. If it ends up being what they think it will, I think that has the potential to be a multi hundred million dollar molecule that MNKD hopefully gets to keep the vast majority.
Ha, I appreciate people's respect, but please don't feel reassured about stocks on my account. I do my best to keep up with stuff but I'm far from an expert. So please proceed with caution and enter at your own risk. BUT! stop chasing the real experts away like matt and the guy who had the Ferdinand-like bull avatar. Don't recall his name.
|
|
|
Post by stevil on Dec 11, 2022 17:06:35 GMT -5
Insulin doesn't cause weight loss. Not sure why someone would do that...
|
|
|
Post by stevil on Dec 11, 2022 16:48:54 GMT -5
I believe that Mike C and MNKD wouldn't want to harp on the "weight loss" aspect ... because you will end up with people taking it just to lose weight. Definitely not where we want to be ... with possibility of law suits. But, that's mytakeonit Wegovy has been FDA approved for obesity. I've read on online physician messages boards that they're often getting patients approved for prediabetes as well if they have evidence of further metabolic syndrome with obesity even for the non-wegovy semaglutide. Obesity is probably the most prevalent disease in America. That's an indication you WANT to treat. Also, I havent looked into it at all but it would seem to me you wouldn't want Afrezza to get mixed with a GLP-1 or GIP as that could cause hypoglycemia. When they first came out, they were twice daily dosing. As aged said, they've been working on extending the duration since then. There is a GLP-1/basal formulation out there that I don't think many people prescribe. I suspect that's probably why you haven't seen novolog/humalog get mixed, either. I'm sure it's been thought about and considered. I highly doubt anyone is taking advice from this board.
|
|
|
Post by stevil on Dec 7, 2022 2:00:16 GMT -5
I'm partially piling on because you're one of the most polarizing and opinionated people on this board. You don't seem to take arguments personally. If so, let me know and I'll back off.
One thing I have noticed about your personality is that you are... Well polarizing and black and white in your thinking. You also seem to get fixated on things and can't stay open-minded and think you have the solutions.
I'm willing to wager that a good reason MNKD doesnt have a GLP-1 molecule of their own is because they didn't develop one. While not impossible for them to have done so considering both lilly and novo have theirs, it could be as simple as a patent infringement prohibiting them from doing so. I am amazed at your research ability. I didn't even know GLP-1s have been developed for 15 years (unless that was a dramatic overreaction), but if it truly was that long ago, it may be the company who created it is waiting closer to when the molecule goes generic to refile a patent to extend brand exclusivity like we're seeing with Tyvaso. Food for thought. I'm not too smart in the business world, but a lot of things in the medical world that you propose are pretty preposterous... It could be the same on the business side as well. Things are rarely as easy to execute as they appear. If they were, there would be far more successful people.
|
|
|
Post by stevil on Dec 7, 2022 1:33:27 GMT -5
GLP-1s go from a puke your guts out medication that causes life threatening pancreatitis and thyroid cancer to now being allowed OTC 🤔
Say hey, I'll give you credit for some things. But you nearly lose all of your credibility with statements like this. At least be consistent... You either care about people's health or their health be damned at the expense of making you some money.
And neither Afrezza nor any GLP-1 will ever be available OTC. Super glucose fighting powder or super diet powder will never be available for general consumers to self medicate. It gets really hard to respect your opinion on anything medical when you don't see how this is an obviously horrible idea.
Might as well throw a wet blanket on your VDex standard of care as well. You can't just make a protocol and call it standard of care. That's not how things work. Not a single doctor will pay attention or respect a self-declared standard of care. By definition, a standard is the metric all other care is measured against. VDex very well may be instrumental in developing the future standard of care, but until there is significant consensus with their findings, it will not be a standard of care.
|
|
|
Post by stevil on Dec 5, 2022 16:13:22 GMT -5
Not gonna lie, say hey.
I want nothing more for MNKD to make a GLP-1 just so I can watch you change your tune on them.
For all the puking up of their guts, people sure can’t get enough of them 🤪
|
|
|
Post by stevil on Nov 11, 2022 9:38:44 GMT -5
If you guys want Afrezza to become the standard of care, this is MNKDs time to shine by proving superior long term outcomes and listing measurable improvements to comorbid conditions with better PPGE control. I know there is already data out there that shows benefit, but Afrezza has never been studied to this extent and there's never been a tool that can replicate the control Afrezza gives.
|
|
|
Post by stevil on Nov 6, 2022 15:01:21 GMT -5
FWIW, I'm with Aged on this one. I think everyone would have been shocked if Afrezza DIDN'T have a greater A1c reduction compared to orals. At best it just proved that FKDP is an appropriate carrier molecule for insulin. Insulin should always be superior to any other molecule for glucose reduction. That's nearly the entire role of insulin, to reduce serum glucose. It becomes something else entirely if you can show insulin is just as safe or safer than orals and leads to better long term outcomes in a cost/benefit analysis. That work has not yet been completed as far as I have seen.
As far as I personally am concerned, I'll continue to root for Afrezza to become the next standard of care, but I'm still not (yet) convinced it should be. Still far too much to prove. There are numerous disease states with a treat to fail mentality that work just fine. It doesn't make sense to use a bazooka to kill an ant when a shoe will yield the same results. I haven't seen anyone successfully master diabetes in the sense that they can differentiate early in the disease whether you're dealing with an ant or a tank (and thus would need the bazooka sooner). I'm not yet convinced that everyone NEEDS Afrezza. I have seen people do just fine on Metformin for decades, literal decades with an A1c less than 6 the whole time, confirmed by chart review. He even stopped it because he wasn't sure he was even diabetic and his A1c went up to 7 and a half. Then it came right back down again within a few months on metformin.
I will state again that I have immense respect for Bill and VDex but I don't yet agree on Afrezza First, Afrezza Last, Afrezza Always. And I really, really wanted to as a MNKD shareholder. But if I'm being honest with myself, not everyone needs Afrezza and I don't think the data or my own personal experience supports that as a protocol. I don't disagree with Bill or VDex in how they want to go about their business. Someone needs to do that heavy lifting and try it out so the rest of us can see what they are able to do with their results. Their logic makes sense and time will tell what the results are. Hopefully we all get to see the end results.
There is not yet a successful algorithm for diabetes treatment, mostly because nearly ever patient is unique, going back to the ant and the tank analogy. We've identified some markers/genes to go off of, but the great majority of treatment right now is "wait and see". Sure, you could treat them all with insulin and get great A1c results. I would be surprised if Afrezza didn't get better A1c reduction than just about any treatment unless compliance becomes an issue. But it becomes incredibly expensive to kill ants with bazookas when shoes work just as well. Then, during the transformation of the ant to the tank, which medication offers better protection from that little ant turning into the tank and wreaking havoc on the rest of its environment? Theories abound and data is limited.
Personally, I like GLP-1s/Mounjaro for my obese patients who likely would be nondiabetic if they lost their excess weight. I also like it for the cardiac risk patients. Also like SGLT-2s for renal and CHF patients. Early in the disease? I'd try to go Afrezza to avoid complications. Until Afrezza shows superiority in the comorbidities, it's going to be a hard sell, even for this shareholder. There's just too much evidence to support the use of the other medications while there is an abyss of data for Afrezza's use. I can't give patients Afrezza when I'm not sure if it's the superior medication for their ailments when I have an avalanche of data to show that GLP-1s and SGLT-2s are so effective, beyond even diabetes. They're using SGLT-2s in renal/CHF patients without diabetes, which suggests their benefits extend beyond glucose control. There's a separate mechanism at play that Afrezza cannot even account for.
|
|