|
Post by sophie on Sept 1, 2016 22:11:45 GMT -5
I have posted this before but seems relevant again... I had dinner with Sam F and he told me regarding the lung safety issue the following: "When I weigh the chance for the POSSIBILITY of cancer or other lung issues related to using AFREZZA which have yet to show themselves in any statistical meaningful way (with all the testing of 1,000's of patients over the course of the trials) versus the CERTAINTY that with my Hba1c in the 10''s (he admitted to being out of control most of his life despite a rigorous work out regime and watching what he ate) prior to starting AFREZZA (he is now in non-diabetic range) that I would likely go blind, suffer kidney and heart damage and loss of limbs... It was really a very clear choice for me. The market says otherwise. Personally, I would agree with Sam F, except his opinion isn't the only one that matters. I would not want physicians making personal decisions like that about my healthcare. As much as I hate that doctors are being careful prescribing something they're not familiar/comfortable with, I have to honor and respect that because it's that very practice that likely keeps many more people safe. There are countless cancer inhibitors that have been rejected by the FDA after showing promising results, yet patients can't get their hands on it because it didn't pass their standards. Some successful drugs have killed specific ethnicities then get pulled off the market. Afrezza has proven to be safe enough in the near term. I hope as much as anyone that no adverse effects come from chronic use. But caution exists for a reason and that's all I've been trying to share. If I was a doctor I would inform all my diabetic patients about Afrezza so they could make the best choice for themselves. But I think it would be imprudent for one to do so without mentioning that there isn't enough evidence yet to support the safety of chronic use. And I can't speak for any of the doctors I have talked to. I'm just explaining as best as I can why I think they said what they said. I did some of my own research to try to understand and after doing so, I think they are being too conservative, but it's their license and conscience to do with what they please. Do no harm was their oath. They don't see insulin as being the major issue. Maybe if, like Sam, all other boxes could be checked, they may be more aggressive with their treatment. Who knows.
|
|
|
Post by mnholdem on Sept 1, 2016 22:28:29 GMT -5
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Sept 1, 2016 23:08:04 GMT -5
There are other inhaled drugs www.aaaai.org/conditions-and-treatments/library/at-a-glance/inhaled-asthma-medications"Inhaled corticosteroids, also referred to as topical corticosteroids or glucocorticosteroids, are anti-inflammatory medications that have been used successfully to treat asthma for over 50 years" Also think of all the dust, pollen, smoke, smog and everything else people breath in every day and the lungs filter this out and are not damaged. No compare that to TI which is almost entirely absorbed into the body and leaves very little residue in the lungs. I would like to see a comparison of the dangers of the morning commute to work in traffic and inhaling TI on a PPM, particle size and how far into the lungs each one gets. People forget the lungs and skin are filters and very good ones, yes you do not want to abuse them, but calling them delicate and treating them like they are extremely fragile in regards to the testing TI has went through should also be warning you about breathing smog and everything else which has unknown long term affects. Do you know where the air you are breathing has been? You are correct. There are other inhaled drugs. There is one key part here that I think you might be overlooking though. An asthmatic doesn't have a choice on whether to use an inhaler or take a pill. I don't know enough about medicine to know if anything IM can be given, but the easiest and safest way to administer bronchodilators was through a propellant that acts directly onto the smooth muscle in the trachea. The same can't be said about insulin. At least not yet. The trials have shown that FDKP breaks apart at the pH of the lungs and is filtered by the kidneys and passes through the urine, but how do we know which is safer? To your next point- it would be better for us all if we didn't breath all that nasty junk in the air. Our lungs only want nitrogen and oxygen in and carbon dioxide out. Anything else could potentially be harmful. There has been increased incidence of lung cancers in urban areas where there is more smog. Just because we're already forced to breathe polluted air doesn't mean we should make matters worse and pile on more. There actually is a huge difference between the two. Injury to the skin from a needle will heal in a day or two. Injury to the lungs may be irreparable, depending on the injury. If you inhale something, it doesn't just stay in one spot like a needle. It spreads throughout the whole organ. Also, no one ever got cancer from sticking themselves with a needle. People have gotten cancer from inhaling things. All that said, I don't think Afrezza is unsafe. There have been lots of studies showing that it is. But you can't say that just because you breathe crap in all the time means it's ok to breathe in any crap. Otherwise, smoking wouldn't be harmful. There is one key part here that I think you might be overlooking though. An asthmatic doesn't have a choice on whether to use an inhaler or take a pill.— Besides MDI (inhaler) form there is pill, liquid, and nebulized forms of the bronchodilator, Albuterol. I don't know enough about medicine to know if anything IM can be given, but the easiest and safest way to administer bronchodilators was through a propellant that acts directly onto the smooth muscle in the trachea.
— What do you think about the bronchodilator Epinephrine? It’s already given via IM, nebulized, and MannKind wants to make an dry powder inhaled version. The same can't be said about insulin. At least not yet. The trials have shown that FDKP breaks apart at the pH of the lungs and is filtered by the kidneys and passes through the urine, but how do we know which is safer?
— No comment. To your next point- it would be better for us all if we didn't breath all that nasty junk in the air. Our lungs only want nitrogen and oxygen in and carbon dioxide out. Anything else could potentially be harmful. — See my other post to you pointing out everything else you neglect to consider “the makeup of air”. There has been increased incidence of lung cancers in urban areas where there is more smog. Just because we're already forced to breathe polluted air doesn't mean we should make matters worse and pile on more.— How many emails do you send monthly to the white house, FDA, and Big Tobacco, etc about what THEY allow into the lungs and profitize from the mass murder they allow? There actually is a huge difference between the two. — Yet, inhaled Afrezza is superior to injectibles. Injury to the skin from a needle will heal in a day or two. Injury to the lungs may be irreparable, depending on the injury.
— Interesting. Here I was thinking lipohypertrophy was a CHRONIC complication. Also, no one ever got cancer from sticking themselves with a needle.— Hi, I'm mango and I will call you out. Colonic adenocarcinoma via needle-stick: pub.extranet.fsu.edu/sites/safety/safetywiki/Wiki%20Documents/Needlestick%20Transmission%20of%20Cancer.pdf—That’s just one example. All that said, I don't think Afrezza is unsafe.— FUD. Apparently you do. There have been lots of studies showing that it is. But you can't say that just because you breathe crap in all the time means it's ok to breathe in any crap. Otherwise, smoking wouldn't be harmful.
— Afrezza is not “crap”.
|
|
|
Post by longstocking on Sept 1, 2016 23:34:38 GMT -5
Hi liane, I made no comparison between smog and Afrezza. I was replying to someone who did. I'm not trying to make a snide remark, but you sort of prove my point in a way. Something that appears relatively harmless like stabbing yourself with a needle, if done enough, can cause damage years down the line that wasn't immediately obvious. This is more for my own curiosity and not to be snarky, but has anyone been on Afrezza for 10 years and used it every day? I've wondered if there is data for long term effects. Don't kill yourself to find it if you don't know where it is. I'm sure you have better things to do. I'm just curious. Anyway, my point wasn't to say Afrezza was harmful if inhaled. We know that there are no immediate effects of it other than what, cough? My point was more that we should try to keep just oxygen and nitrogen in the lungs because that's all that they need. I know that FDKP is inert, but so were CFCs that I mentioned in one of my earlier posts. I'm sure you know this if you're a doctor- catalysts don't change in a reaction. They go in as one thing and come out the same way. I'm not sure how it's possible to track them all the way through the body to make sure they don't dissociate, but hopefully this was already taken into consideration. I'm not really trying to argue a point. I'm just trying to say that we can't really say for sure what the long term effects are because it's still a relatively new drug. I invested in this company knowing all of this already. I've spoken to a few docs about why they won't prescribe it and they mention the required spirometry test makes them nervous. They don't want to cause harm to their patients. I'm not a doctor so I'm not going to tell you how you think, but the ones I've spoken to (PCPs not endocrinologists) say that adherence, lifestyle, and proper dosing is more the problem than the quality of the insulin. But that's probably because they figure the endos will fix the ones that can't keep their control down so they don't deal with the really bad ones. Something that appears relatively harmless like stabbing yourself with a needle, if done enough, can cause damage years down the line that wasn't immediately obvious.— Injecting yourself multiple times daily is relatively harmless? So these doctors that you keep mentioning that are worried about potential future lung problems regarding Afrezza, were they the same ones that never thought about an obvious future problem with injections? Also, have they even read the studies regarding Afrezza? Clamp studies? This is more for my own curiosity and not to be snarky, but has anyone been on Afrezza for 10 years and used it every day? I've wondered if there is data for long term effects. Don't kill yourself to find it if you don't know where it is. I'm sure you have better things to do. I'm just curious. — Afrezza has not been available for 10 years. My point was more that we should try to keep just oxygen and nitrogen in the lungs because that's all that they need. I know that FDKP is inert, but so were CFCs that I mentioned in one of my earlier posts.— What are you suggesting? That our lungs only need oxygen and nitrogen? What about all the other things you breathe into your lungs? argon, CO2, neon, helium, Methane, krypton, nitrogen oxide, hydrogen, xenon, and….Ozone? I'm not really trying to argue a point. I'm just trying to say that we can't really say for sure what the long term effects are because it's still a relatively new drug.— Yes, you are trying to argue a point. You have brought this up more than once. If you are that worried about companies are trying to put into peoples lungs I suggest you advocate the crumble of Big Tobacco and the FDA and everyone else involved with mass murder. I invested in this company knowing all of this already. — Sounds like you still have a lot of doubts. I've spoken to a few docs about why they won't prescribe it and they mention the required spirometry test makes them nervous. — Sounds like the docs you know/speak to are close minded and prefer to stick with what they were taught. Did you know that a spirometry test is actually a very common test performed in the hospital and in clinics? Also: those same docs probably prescribe several drugs (pills) just because they get a free lunch (speculating here, but speculating based on fact). They don't want to cause harm to their patients.— I disagree, and will also add: They also don’t want to join present day innovation. I'm not a doctor so I'm not going to tell you how you think, but the ones I've spoken to (PCPs not endocrinologists) say that adherence, lifestyle, and proper dosing is more the problem than the quality of the insulin.
— This applies to so much more than just diabetes. This is just an EXCUSE, and nothing else. But that's probably because they figure the endos will fix the ones that can't keep their control down so they don't deal with the really bad ones.
— Wrong. Plenty of PCPs deal with difficult diabetics. Fact. Who is Sophie? Must be one of the posters I blocked a while ago.
|
|
|
Post by sophie on Sept 1, 2016 23:35:04 GMT -5
I'm pretty sure I did at one point. It looks familiar. I did a lot of research before investing and fell in love with the drug. I didn't think physician adoption would be such a hurdle, and I didn't think much of it except that there are so few prescribers that we need a website to find ones that do. I know part of that is due to lazy Sanofi reps. I'm pretty good with science and I mostly understand how everything works with FDKP from what I have read and seen. I haven't looked far enough into how the physiological tests were done... if there were biomarkers involved somehow that allowed them to trace the FDKP completely through the process, more so than an output= %input equation. In studying science, I've learned that very few things are truly inert. Noble gases can even be coaxed into reacting with nearby molecules under specific circumstances. I'm not claiming that FDKP reacts with anything- for all we know it doesn't. I'm just trying to support the claims of the docs I've talked to in a coherent way for everyone to understand. Going in one way and coming out the same does not mean that it doesn't interact with anything else along the way. The fact that some of it does get lost (as you said minuscule amount), means that it may, in fact, react with some things. Given enough time, it's feasible to assume that it might be harmful. Or it may not be. But potential exists and that's why docs are hesitant. That's all I'm saying.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Sept 1, 2016 23:59:15 GMT -5
I'm pretty sure I did at one point. It looks familiar. I did a lot of research before investing and fell in love with the drug. I didn't think physician adoption would be such a hurdle, and I didn't think much of it except that there are so few prescribers that we need a website to find ones that do. I know part of that is due to lazy Sanofi reps. I'm pretty good with science and I mostly understand how everything works with FDKP from what I have read and seen. I haven't looked far enough into how the physiological tests were done... if there were biomarkers involved somehow that allowed them to trace the FDKP completely through the process, more so than an output= %input equation. In studying science, I've learned that very few things are truly inert. Noble gases can even be coaxed into reacting with nearby molecules under specific circumstances. I'm not claiming that FDKP reacts with anything- for all we know it doesn't. I'm just trying to support the claims of the docs I've talked to in a coherent way for everyone to understand. Going in one way and coming out the same does not mean that it doesn't interact with anything else along the way. The fact that some of it does get lost (as you said minuscule amount), means that it may, in fact, react with some things. Given enough time, it's feasible to assume that it might be harmful. Or it may not be. But potential exists and that's why docs are hesitant. That's all I'm saying. I'm pretty good with science and I mostly understand how everything works with FDKP from what I have read and seen.
— No, you like to say you don’t know anything about medicine/science or xyz and then try to explain it like you know everything. You never provide sources for anything you say either. If you know everything about FKDP “from what you have read and seen”, then you are sadly contradicting yourself via with my last (2nd) reply to you. I haven't looked far enough into how the physiological tests were done... if there were biomarkers involved somehow that allowed them to trace the FDKP completely through the process, more so than an output= %input equation. In studying science, I've learned that very few things are truly inert. Noble gases can even be coaxed into reacting with nearby molecules under specific circumstances. I'm not claiming that FDKP reacts with anything- for all we know it doesn't. — You just said you mostly understand and know how everything works with FDKP from what you have "read and seen." Perhaps you have not read and seen enough. I'm just trying to support the claims of the docs I've talked to in a coherent way for everyone to understand. — Why do you worship these “doctors” so much? Nearly every post you make has to include these“doctors”. I think introducing “doctors” in your sentences is the method you use to try and “show” what you really do not know (create FUD), and sadly look ignorant doing so. Going in one way and coming out the same does not mean that it doesn't interact with anything else along the way. The fact that some of it does get lost (as you said minuscule amount), means that it may, in fact, react with some things.— You are literally digging for anything at this point, so obvious. Of course this assumption is based strictly on what I have read and seen of yours in the past. Given enough time, it's feasible to assume that it might be harmful. — I do not like you. You are contradicting yourself entirely from what you have previously said (which you seem pretty good at) in past recent posts of yours, specifically the ones I have replied to. Or it may not be.— FUD. But potential exists and that's why docs are hesitant. That's all I'm saying. — That’s all you have been saying since you started posting here.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Sept 2, 2016 2:09:51 GMT -5
Kudos to Mike C. That's the kind of leader I'd want in my company. If something big was on the near horizon I feel Matt would be a little more bullish with his shares also. 25k is a lot but if I had a ton of money and knew something was about to take off, I'd scoop up more than that. If Matt jumps in with more, I might be forced to. Matt has plenty of stock options. Also, how do you know Matt has a ton of money? Why should he put more money into shares? Maybe your definition of financial sense if different than a seasoned CFO? Honestly, it really doesn't matter what you or I think about this, it is HIS money. Do your homework and understand that there are other outside factors besides Afrezza scripts that can potentially launch MannKind onto solid ground and help all these things. Personally, that is what I think and have been saying it since I joined this place. I don't agree with you one sliver of a bit, but neither do majority of the people here agree with what I say either. Bottom line is this: management listened. That means more to me that one of them purchasing 1 million shares. Most conservative wealthy folks lives modestly and spend modestly. I have NEVER once commented that I wished Matt would buy more. He has far too much to manage on a daily basis that you or I could ever comprehend.
|
|
|
Post by agedhippie on Sept 2, 2016 11:14:04 GMT -5
Lipohypertrophy is a chronic complication if you continually inject in the same place. Rotate your sites and you can avoid it - it's the first thing your CDE should tell you. Your reference was not relevant. It was about a lab worker accidentally injecting themselves with a cancer cell line - hardly the same as an insulin shot!
|
|
|
Post by mannmade on Sept 2, 2016 12:22:24 GMT -5
I have posted this before but seems relevant again... I had dinner with Sam F and he told me regarding the lung safety issue the following: "When I weigh the chance for the POSSIBILITY of cancer or other lung issues related to using AFREZZA which have yet to show themselves in any statistical meaningful way (with all the testing of 1,000's of patients over the course of the trials) versus the CERTAINTY that with my Hba1c in the 10''s (he admitted to being out of control most of his life despite a rigorous work out regime and watching what he ate) prior to starting AFREZZA (he is now in non-diabetic range) that I would likely go blind, suffer kidney and heart damage and loss of limbs... It was really a very clear choice for me. The market says otherwise. Personally, I would agree with Sam F, except his opinion isn't the only one that matters. I would not want physicians making personal decisions like that about my healthcare. As much as I hate that doctors are being careful prescribing something they're not familiar/comfortable with, I have to honor and respect that because it's that very practice that likely keeps many more people safe. There are countless cancer inhibitors that have been rejected by the FDA after showing promising results, yet patients can't get their hands on it because it didn't pass their standards. Some successful drugs have killed specific ethnicities then get pulled off the market. Afrezza has proven to be safe enough in the near term. I hope as much as anyone that no adverse effects come from chronic use. But caution exists for a reason and that's all I've been trying to share. If I was a doctor I would inform all my diabetic patients about Afrezza so they could make the best choice for themselves. But I think it would be imprudent for one to do so without mentioning that there isn't enough evidence yet to support the safety of chronic use. And I can't speak for any of the doctors I have talked to. I'm just explaining as best as I can why I think they said what they said. I did some of my own research to try to understand and after doing so, I think they are being too conservative, but it's their license and conscience to do with what they please. Do no harm was their oath. They don't see insulin as being the major issue. Maybe if, like Sam, all other boxes could be checked, they may be more aggressive with their treatment. Who knows. I don't disagree with you that it is a doctors choice, but I have dealt with many doctors regarding AFREZZA and let's be honest... Many doctors don't even take the time to understand it and the real world benefits... Many doctors don't like change and go by the motto "don't be the first and don't be the last..." I just met a T2 today in the gym who has an Hba1c in the 7's with BG's often in the high 300's. He is on two different meds one of which is an injectable. After speaking with him today he is going to talk with his endo about AFREZZA. As for Sam's comment yes opinions may vary and there are many but to me it makes a lot of sense and is very rational/logical... Cost benefit is a sound basis for making such decisions... And the known costs in this case are quite high and irreversible...
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Sept 2, 2016 21:13:43 GMT -5
Lipohypertrophy is a chronic complication if you continually inject in the same place. Rotate your sites and you can avoid it - it's the first thing your CDE should tell you. Your reference was not relevant. It was about a lab worker accidentally injecting themselves with a cancer cell line - hardly the same as an insulin shot! Reference was totally relevant. The statement made was, "Also, no one ever got cancer from sticking themselves with a needle." I gave an example of someone doing just that.
|
|
|
Post by agedhippie on Sept 2, 2016 21:22:04 GMT -5
Lipohypertrophy is a chronic complication if you continually inject in the same place. Rotate your sites and you can avoid it - it's the first thing your CDE should tell you. Your reference was not relevant. It was about a lab worker accidentally injecting themselves with a cancer cell line - hardly the same as an insulin shot! Reference was totally relevant. The statement made was, "Also, no one ever got cancer from sticking themselves with a needle." I gave an example of someone doing just that. Semantics. It was obvious that they meant injecting insulin.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Sept 2, 2016 21:43:45 GMT -5
Reference was totally relevant. The statement made was, "Also, no one ever got cancer from sticking themselves with a needle." I gave an example of someone doing just that. Semantics. It was obvious that they meant injecting insulin. Here's the entire paragraph for reference: "There actually is a huge difference between the two. Injury to the skin from a needle will heal in a day or two. Injury to the lungs may be irreparable, depending on the injury. If you inhale something, it doesn't just stay in one spot like a needle. It spreads throughout the whole organ. Also, no one ever got cancer from sticking themselves with a needle. People have gotten cancer from inhaling things."I don’t see anything in this paragraph that suggests OP meant cancer from injecting insulin.
|
|
|
Post by agedhippie on Sept 2, 2016 22:00:57 GMT -5
Semantics. It was obvious that they meant injecting insulin. Here's the entire paragraph for reference: "There actually is a huge difference between the two. Injury to the skin from a needle will heal in a day or two. Injury to the lungs may be irreparable, depending on the injury. If you inhale something, it doesn't just stay in one spot like a needle. It spreads throughout the whole organ. Also, no one ever got cancer from sticking themselves with a needle. People have gotten cancer from inhaling things."I don’t see anything in this paragraph that suggests OP meant cancer from injecting insulin. Are you really going with that line of argument?
|
|
|
Post by beardawg on Sept 5, 2016 7:15:01 GMT -5
Here's the entire paragraph for reference: "There actually is a huge difference between the two. Injury to the skin from a needle will heal in a day or two. Injury to the lungs may be irreparable, depending on the injury. If you inhale something, it doesn't just stay in one spot like a needle. It spreads throughout the whole organ. Also, no one ever got cancer from sticking themselves with a needle. People have gotten cancer from inhaling things."I don’t see anything in this paragraph that suggests OP meant cancer from injecting insulin. Are you really going with that line of argument? Did the cancer spread after being injected? Same as inhaling. I think it's relevant.
|
|
|
Post by cjm18 on Sept 5, 2016 8:14:43 GMT -5
Are you really going with that line of argument? Did the cancer spread after being injected? Same as inhaling. I think it's relevant. People got cancer from inhaling things? What things? Let's name them....... Carcinogens. Can you think of any others? Do people inject carcinogens? and here's a great reason for the spirometey test. And not allowing smokers to be on afrezza. www.m.webmd.com/a-to-z-guides/news/20000510/asthma-patients-higher-risk-for-lung-cancer
|
|