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Post by bill on Dec 2, 2015 20:00:20 GMT -5
The biggest setback I think is that its inhaled via the lung. So many out there think its the same as smoking cigarettes. Non educated diabetics are going to think like this. Via Lung= danger OK biotec, I see you've switched to a new line of reasoning by dropping skepticism about whether Afrezza works to one that says PWDs are avoiding using it because they think Afrezza is as dangerous as smoking cigarettes. OK, let's go there. What evidence can you provide that this fear not only exists, but that it's "the biggest setback" to adoption--your words, not mine? |
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Post by kc on Dec 2, 2015 20:03:15 GMT -5
Ashiwi and Spiro have known about this meeting for several months. Apparently, quite a few individuals are involved. I am sure someone will spill their guts about it over the weekend. You know, with MNKD and SNY everything is a big secret, but they may actually be doing something the right way on this one. Time will tell. Spiro here Many of us heard, but kept a MANNKIND type of secret. |
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Post by biotec on Dec 2, 2015 20:05:43 GMT -5
Changing the lives of many! the 10 or so on social media? The same every week we hear about. Is that your gage? Ill be more happy when its changing thousands. How many people that tried Afrezza and it's not working for them? You have a number? I don't but I'm sure there's many. Total number of prescriptions written as of November 14th: 16,844. Hundreds of refills every week. Seems to me that adds up to "thousands" who are satisfied. 16,844 prescriptions since Feb. Watch out the blockbuster police are coming out! |
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Post by jeremg on Dec 2, 2015 20:07:48 GMT -5
The biggest setback I think is that its inhaled via the lung. So many out there think its the same as smoking cigarettes. Non educated diabetics are going to think like this. Via Lung= danger This is very simplistic reasoning and does not fall in line with reality based on the fact that many commonly prescribed drugs are inhaled for many common conditions - used daily (e.g. Asthma) |
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Post by biotec on Dec 2, 2015 20:13:47 GMT -5
The biggest setback I think is that its inhaled via the lung. So many out there think its the same as smoking cigarettes. Non educated diabetics are going to think like this. Via Lung= danger OK biotec , I see you've switched to a new line of reasoning by dropping skepticism about whether Afrezza works to one that says PWDs are avoiding using it because they think Afrezza is as dangerous as smoking cigarettes. OK, let's go there. What evidence can you provide that this fear not only exists, but that it's "the biggest setback" to adoption--your words, not mine? Just common sense. Did you ever read the Black box warning? Do you understand what a lung spirometry is for? |
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Post by Deleted on Dec 2, 2015 20:26:45 GMT -5
OK biotec , I see you've switched to a new line of reasoning by dropping skepticism about whether Afrezza works to one that says PWDs are avoiding using it because they think Afrezza is as dangerous as smoking cigarettes. OK, let's go there. What evidence can you provide that this fear not only exists, but that it's "the biggest setback" to adoption--your words, not mine? Just common sense. Did you ever read the Black box warning? Do you understand what a lung spirometry is for? So far, no lung issues with Afrezza in trials or real world. Ultimate test to validate no long term issues will be father time as it is with any Rx product. Only so much information can be obtained from a trial. Postmarket will determine when black box gets erased. I believe it is GSK who put up significant $$ to develop inhaled R&D facility in Sweden. Tried to find article in Fierce Drug Delivery but it was a year or so ago. If I find, I will share. |
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Post by biotec on Dec 2, 2015 20:30:20 GMT -5
The biggest setback I think is that its inhaled via the lung. So many out there think its the same as smoking cigarettes. Non educated diabetics are going to think like this. Via Lung= danger This is very simplistic reasoning and does not fall in line with reality based on the fact that many commonly prescribed drugs are inhaled for many common conditions - used daily (e.g. Asthma) Asthma drugs help open the airway ( helps the lungs function) Not any where close to inhaling of other particles. |
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Post by bill on Dec 2, 2015 20:31:45 GMT -5
OK biotec , I see you've switched to a new line of reasoning by dropping skepticism about whether Afrezza works to one that says PWDs are avoiding using it because they think Afrezza is as dangerous as smoking cigarettes. OK, let's go there. What evidence can you provide that this fear not only exists, but that it's "the biggest setback" to adoption--your words, not mine? Just common sense. Did you ever read the Black box warning? Do you understand what a lung spirometry is for? Ah, biotec this is getting tedious, but I'll indulge you once again even though your writing style reminds me of several YMB MNKD bashers. Let's start with "common sense." Common sense would say that Afrezza isn't as damaging to the lungs as a cigarette based on the MNKD study that examined lung tissue of early participants after they'd been using Afrezza for several years. They found no damage whatsoever, not to mention the study that showed that 90+% of the TS particles were excreted, i.e., not left lining the lungs. Finally, note that users will probably inhale Afrezza cartridges between 3 and 5 times a day, on average--one puff per cartridge. A single cigarette gets consumed with about 10 puffs. Therefore, even if Afrezza were as dangerous to the lungs as a cigarette it would be no worse than smoking one cigarette every other day. That comes to less than a pack per month in cigarette consumption. Now let's move on to the Black box warning and lung spirometry. The warning and the spirometer test are there to warn physicians not to prescribe Afrezza to PWDs who's lungs are already compromised because of the increased risk of bronchospasms. It's totally irrelevant for anyone without lung problems which is the category of patients that will be using Afrezza. |
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Post by phantomfj on Dec 2, 2015 20:41:31 GMT -5
The biggest setback I think is that its inhaled via the lung. So many out there think its the same as smoking cigarettes. Non educated diabetics are going to think like this. Via Lung= danger LOL! That is way out there, tell me another one! |
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Post by biotec on Dec 2, 2015 20:44:49 GMT -5
Just common sense. Did you ever read the Black box warning? Do you understand what a lung spirometry is for? Ah, biotec this is getting tedious, but I'll indulge you once again even though your writing style reminds me of several YMB MNKD bashers. Let's start with "common sense." Common sense would say that Afrezza isn't as damaging to the lungs as a cigarette based on the MNKD study that examined lung tissue of early participants after they'd been using Afrezza for several years. They found no damage whatsoever, not to mention the study that showed that 90+% of the TS particles were excreted, i.e., not left lining the lungs. Finally, note that users will probably inhale Afrezza cartridges between 3 and 5 times a day, on average--one puff per cartridge. A single cigarette gets consumed with about 10 puffs. Therefore, even if Afrezza were as dangerous to the lungs as a cigarette it would be no worse than smoking one cigarette every other day. That comes to less than a pack per month in cigarette consumption. Now let's move on to the Black box warning and lung spirometry. The warning and the spirometer test are there to warn physicians not to prescribe Afrezza to PWDs who's lungs are already compromised because of the increased risk of bronchospasms. It's totally irrelevant for anyone without lung problems which is the category of patients that will be using Afrezza. Not once did I say Afrezza was the same as smoking! I said uneducated people might and will think that! And that's why I think the low acceptance with doctors and patient is do the the fact it might hurt there lungs. Why do you thing the low acceptance? |
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Post by dreamboatcruise on Dec 2, 2015 20:45:03 GMT -5
Do you know something we don't know? I have been tracking refills and the growth looks very good, very linear though it could be better. I would not make too many assumptions about the samples. For years I have not had any prescriptions but at one time, I would love to try anything new (that made me feel better about corporate life), and when I did, the doc (knew I was a chemist) would not bother with an Rx, just give me bottles of samples! That's perfectly legal, nobody can tell the docs what to do with their samples as far as I know. My personal intuition is that maybe Sanofi is amazed at the social media sensation backed by hard data. This kind of stuff just didn't happen in the past. If Sanofi can capture that in some way that's ethical and FDA approved we are talking blockbuster. Early after the "soft launch" I think maybe the Q2 CC. Matt said he was surprised that so many samples was being giving out. How many samples? No one knows its top secret. Like everything else. So with all the samples, Why the script count we have? If you got giving a free Viagra sample and it changed your and your others life you would be nocking the door down for it, I don't see that with Afrezza. 3 out of 4 patients have trouble getting their insurance to pay for it. And this factor probably also means doctors burn through extra samples as they give more and more to the same patients who are waiting on decisions from their insurance authorization requests. And with regard to patients that were in trials, one must factor how many were not in U.S. (unfortunately, I don't have that figure handy). |
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Post by jeremg on Dec 2, 2015 20:50:53 GMT -5
OK biotec , I see you've switched to a new line of reasoning by dropping skepticism about whether Afrezza works to one that says PWDs are avoiding using it because they think Afrezza is as dangerous as smoking cigarettes. OK, let's go there. What evidence can you provide that this fear not only exists, but that it's "the biggest setback" to adoption--your words, not mine? Just common sense. Did you ever read the Black box warning? Do you understand what a lung spirometry is for? I never understood the big deal made about the "black box warning", do you realize how many commonly prescribed medications these days are covered in disclaimers, including my personal favorite - "May cause death", you are like a poster stuck 8 months in the past... the real issues Afrezza currently faces are ones of Insurance Coverage, Pricing, and Advertising - and of course the existential threat posed by our lovely "partner" SNY itself - I am all for healthy skepticism [I'm probably the biggest skeptic on this board] but I think you are not up with the times on the contrarian argument. Afrezza has never been the issue with this company, the issue encompasses everything that surrounds Afrezza, including the company itself. |
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Post by pktrump on Dec 2, 2015 20:52:03 GMT -5
Biotech,
Your statements are not common sense, maybe common misperceptions.
Technosphere is inert: that is it does not incite an inflammatory response. 1000s of HRCT scans (high resolution CT) were performed during phase III that did not reveal any reaction or alveolar changes. Of course Insulin is utilized by every cell in the body: so an inert transporter plus a natural monomer insulin, which is rapidly absorbed with no residual should not have any malignant potential in theory.
I think those of us who live in large metro areas are constantly inhaling known toxins from exhaust & a myriad of other pollutants, not to mention dust, pollen, mold, etc... the lungs are resilient. The black box warning is a classic cover my ass move by the FDA, but welcomed nevertheless by MNKD to keep smokers in particular from using. Given the outrageous and corrupt tort system in the US I think the BB warning gives MNKD some liability protection from the inevitable lawyer scum.
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Post by bthomas55ep on Dec 2, 2015 20:53:54 GMT -5
Agreed about misperceptions about lung implications. Have had Asthma since childhood. From taking primatine mist throughout the 70's to a Ventolin inhaler regularly from the 80's to now..... No lung issues or scar tissue. Medication and propellent must be similar to TS particle and insulin absorption effect. Based on this experience, I can buy that Afrezza would be okay to use and has no comparison to cigarette effects.
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Post by ezrasfund on Dec 2, 2015 20:57:36 GMT -5
The two problems highlighted here are real. Both require that doctors get on board and educate their patients properly.
As I have said before, smoking doesn't cause cancer...tobacco does, and tobacco also causes cancer if you chew it. But the association of smoking, or anything you breathe, is erroneously, but strongly, linked to fear of cancer. This is something that needs to be overcome. (I have just been reading Daniel Kahneman, "Thinking, Fast and Slow" and if you think the association is not strongly made, you are only fooling yourself.)
The other issue is dosing. Proper dosing of RAA's can be a matter of life and death. The dosing regimen is hard to master. Afrezza may be easier to use and less dangerous than existing RAA's, but the dose timing is very different. Patients and doctors need to unlearn their old protocols and often dose in a way that would be dangerous with the old drugs. This problem was one of the reasons the Phase 3 trials were so timid with Afrezza dosing instructions (and even then, FDA statisticians thought that Afrezza dosing was creating an unfair comparison.) As we now know, Afrezza is best dosed right after the beginning of the meal; and with larger meals or foods like pizza a follow-up dose is more effective than trying to take one large dose which will "wear off" too quickly.
And this is the low hanging T1 fruit. Right now mealtime insulin is the last resort for T2's, and with Afrezza it should be a first line treatment. That will also take plenty of re-education.
Eventually diabetics and doctors will learn, and Afrezza will succeed. Whether MannKind will still be around when that happens is the question.
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