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Post by lakon on Feb 2, 2017 10:30:11 GMT -5
mnkdnewb I did not miss it. Statistically 'well controlled' on paper is very different from 'well controlled' physiologically. That is the only way MannKind will convince the medical community. Statistically well controlled on paper is enough to keep almost every diabetic from spending their own money in something that is hypothetically better. a Dr can only say it isn't worse than regular insulin thanks to the label MNKD may only say Afrezza is non-inferior to RAA, which is superior to regular insulin. Did you see what I did there? If the logic is wrong, someone needs to do some explaining before they get Trumped... A doctor may say whatever he believes is medically correct based on his own knowledge and experience. He could recommend Afrezza for his patients because he has seen that his patients get superior results. He could say it to his patients as well as publicly. The FDA does not regulate doctors or their speech.
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Post by lakon on Feb 2, 2017 10:41:07 GMT -5
Well put! That's the best way I've seen it put in a few words. MNKD needs a trial with CGM's on all patients at all times to collect data on patients on Metformin, Metformin+Afrezza, Tresiba, Tresiba+Afrezza, and Tresiba+RAA. Throw in other basal options to round it out. Show time in range statistics in a graph. Propose long-term studies for the effects. If the doctors could see the huge swings, I think that some might wake up. It seems intuitively better to maintain range. "Statistically 'well controlled' on paper is very different from 'well controlled' physiologically." -- TIME IN RANGE! I've watched T2's just pop a pill and think they are good because the doctor looks at the averages while I watch them guzzle pop and get stuffed. I mention Afrezza. They say that they hope to never need insulin, but would rather inhale if it came down to it. Man that would be neat! Just need a few hundred million $$$ and about 9 months and we're all set!It's not really needed, but under the current regulatory nonsense, you are probably correct. That's the problem. I think that Al Mann put it as highly risk averse environment. For some time, I've thought that MNKD needs more hustle. Don't break any laws or regulations, but push it a bit more. Trump's Administration may refocus the regulators on keeping their jobs during right-sizing instead of getting in the way of progress. The hustle in this case would be to get doctors doing their own little in-house "studies" to see the light. Put CGM's on patients that are good. Let them see the ones that are out of range and for how long. Try to help them tighten it up. Lots of little real-time studies...call it The Afrezza Challenge. We will help you improve time in range. This angle might convince a CGM company to play along. Maybe one being launched recently...call it free styling with Afrezza...
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Post by Deleted on Feb 2, 2017 11:05:31 GMT -5
mnkdnewb "The benefits would be marginal at best," That is what is bull. Castagna needs to address this or it will be difficult at best to convince T2s to change. You don't convince seniors to do anything. Most are set in their ways. That is the problem with the t2 market and why its failed so far.
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Post by peppy on Feb 2, 2017 11:44:34 GMT -5
Consider medicine liked that the patient could not see what their blood glucoses were doing. Continuous glucose monitors changed that. Before medicine could blame the patient: compliance, food chooses. Now patients can see how difficult subq fast acting is to work with with continuous glucose monitors. subq fast acting works like chit compared to afrezza.
So in answer to compelling reason, you want the documentation, why afrezza over metformin. First, I have read and listened to people talking about metformin not being so innocent.
Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 • HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.
www.fda.gov/Drugs/DrugSafety/ucm493244.htm I was actually surprised to learn that there are 18 metformin-containing medications on the market, and about 14.5 million patients per year in the United States receive metformin or metformin-containing medications. www.medscape.com/viewarticle/863330 Of course everyone has been concerned about the risk for lactic acidosis with metformin (which is actually relatively rare), particularly in individuals with mild or moderate chronic kidney disease. What is not recommended as part of the new labeling is what some think is appropriate, which is a reduction in the dose of metformin by about 50% in those with an eGFR between 30 and 45 mL/min/1.73 m2.
www.practiceupdate.com/content/fda-revises-recommendation-for-metformin-use-in-patients-with-chronic-kidney-disease/37827
Metabolism and Elimination Intravenous single-dose studies in normal subjects demonstrate that metformin is excreted unchanged in the urine and does not undergo hepatic metabolism packageinserts.bms.com/pi/pi_glucophage_xr.pdf
Distribution Metformin is negligibly bound to plasma proteins, Metformin partitions into erythrocytes,
Notice the increase in blood lipids. Page 13. (In some medical circles increased blood lipid suggestive of increase heart attacks?)
The black box warning for metformin runs several pages long.
Afrezza information. www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf
Good luck
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Post by wildthing on Feb 2, 2017 12:09:24 GMT -5
Explaining to T2 coworkers of the benefits of Afrezza versus metformin is relatively easy, however, because our insurance currently does not cover Afrezza it is difficult for them to make the switch. Are there papers that spell out compelling reasons to switch? The only thing that would convince an insurance company is a trial demonstrating that afrezza use resulted in superior clinical outcomes versus use of metformin. So far, MNKD doesn't appear capable of getting even the almost trivial phase 1 pediatric trial off the ground, so what hope would there be for a afrezza versus metformin trial? Also consider that metformin recently been garnering a great deal of favorable press regarding its ability to inhibit the development of certain cancers. I recall that pancreatic cancer was one where it reduced the risk. And they're even using it to treat cancer now. Who wouldn't want to reduce the risk of cancer while controlling their diabetes?
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Post by peppy on Feb 2, 2017 12:21:05 GMT -5
Explaining to T2 coworkers of the benefits of Afrezza versus metformin is relatively easy, however, because our insurance currently does not cover Afrezza it is difficult for them to make the switch. Are there papers that spell out compelling reasons to switch? The only thing that would convince an insurance company is a trial demonstrating that afrezza use resulted in superior clinical outcomes versus use of metformin. So far, MNKD doesn't appear capable of getting even the almost trivial phase 1 pediatric trial off the ground, so what hope would there be for a afrezza versus metformin trial? Also consider that metformin recently been garnering a great deal of favorable press regarding its ability to inhibit the development of certain cancers. I recall that pancreatic cancer was one where it reduced the risk. And they're even using it to treat cancer now. Who wouldn't want to reduce the risk of cancer while controlling their diabetes? I was surprised by your answer. I decided to look. Many people on cancer therapy are out on corticosteroids like prednisone as an adjunct. corticosteroids raise blood glucose levels. to hyperglycemia.
care.diabetesjournals.org/content/37/7/1786
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Post by agedhippie on Feb 2, 2017 12:21:12 GMT -5
The parameter the medical profession uses to measure results is HbA1c, not time in range. While I agree that time in range is superior it is far harder, and for the insurers, more expensive to do at scale. The reality is that the standard of care is extremely unlikely to move insulin to a first line treatment (I think Amgen is more likely to buy Mannkind to put it in context). Compliance numbers alone would see to that, although costs would be a close second.
The cost to insurers of this change would be staggering. Premiums would rocket. You are moving from a generic costing cents to a CGM and drug costing thousands. Someone will have to pay for that and it won't be the insurers.
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Post by otherottawaguy on Feb 2, 2017 12:35:57 GMT -5
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Post by otherottawaguy on Feb 2, 2017 12:50:41 GMT -5
The above seems to parse out trial info from clinicaltrials.gov. There are numerous references here to Afrezza and Mannkind.
The trial that I am referencing is based in Ghina (hear that is the correct way to pronounce it).
Purpose To evaluate the long-term remission rate of short-term intensive insulin (STII) therapy in newly diagnosed type 2 diabetes outpatients and investigate the predictors contributing to the remission rate.
OOG
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Post by lakon on Feb 2, 2017 12:55:41 GMT -5
The parameter the medical profession uses to measure results is HbA1c, not time in range. While I agree that time in range is superior it is far harder, and for the insurers, more expensive to do at scale. The reality is that the standard of care is extremely unlikely to move insulin to a first line treatment (I think Amgen is more likely to buy Mannkind to put it in context). Compliance numbers alone would see to that, although costs would be a close second. The cost to insurers of this change would be staggering. Premiums would rocket. You are moving from a generic costing cents to a CGM and drug costing thousands. Someone will have to pay for that and it won't be the insurers. I think that there is a difference between what is needed for a trial protocol and a real world protocol. A trial would have to measure (CGM) lots of data points to show improved time in range over just averages; however, once a trial protocol with a CGM showed a statistical improvement of time in range for a dosing protocol, one could leave the CGM (and finger pricks) behind (except every once in a while). Al Mann said the same thing years ago, but I don't think many people understand it to this day. It's such a shame, but I get the feeling that you can understand it if well explained. Hope I did a good enough job. As a PWD, I really wish that you (and lots of others) would try this for yourselves. I think that you would find yourself feeling a lot better, thus realizing how bad you really were feeling. Matt-down-under pointed out the time in range aspect before. Mike C. has mentioned it so I have a bit more confidence in him because he saw the point. In spite of the r/s, it was refreshing to hear the executives getting awfully close to admitting how much corruption is standing in the way. I like how someone else on the board pointed out the old Intel bundling case. There sure are a lot of costly battles ahead. Didn't Warren Buffet get rich off insurance? Didn't Albert Einstein say that compound interest was the most powerful force in the Universe? Yes, staggering. I agree. The insurers love the staggering profits, but not so much spending on patients. Al Mann's concern was that if something was not done to fix the status quo, the system (Global Economy) would fail due to uncontrolled long-term costs from poor medical outcomes due to the trajectory of PWD (400+ million and growing).
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Post by sweedee79 on Feb 2, 2017 13:49:39 GMT -5
The parameter the medical profession uses to measure results is HbA1c, not time in range. While I agree that time in range is superior it is far harder, and for the insurers, more expensive to do at scale. The reality is that the standard of care is extremely unlikely to move insulin to a first line treatment (I think Amgen is more likely to buy Mannkind to put it in context). Compliance numbers alone would see to that, although costs would be a close second. The cost to insurers of this change would be staggering. Premiums would rocket. You are moving from a generic costing cents to a CGM and drug costing thousands. Someone will have to pay for that and it won't be the insurers. If a doctor writes a letter to the insurer saying that the patients needs a certain drug... as long as it is covered I believe the insurers have to pay for it..
Regarding the cost of health care... if there were more preventative measures in the first place there would be fewer expenses down the road.. also pharma needs to stop with the price gouging.. and insurance companies may have to cut down on their profits as well.. It isn't right that so many of these costs get passed onto the patients who are already paying 1K and more a month for insurance premiums... and also have high deductibles.. This in turn is hurting the economy.
Health care costs are going to continue to rise and all of these issues need to be looked at becuz sooner or later it will all come crashing down.. Unfortunately I haven't heard anyone speak of solutions.... but rather a quick fix that will simply kick the can down the road... In the meantime Americans are no longer getting the care they want or need... and becoming less able to pay their bills becuz so much goes to their healthcare.. we are paying a lot for mediocrity.. and metformin isn't that great..
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Post by agedhippie on Feb 2, 2017 13:53:54 GMT -5
I think that there is a difference between what is needed for a trial protocol and a real world protocol. A trial would have to measure (CGM) lots of data points to show improved time in range over just averages; however, once a trial protocol with a CGM showed a statistical improvement of time in range for a dosing protocol, one could leave the CGM (and finger pricks) behind (except every once in a while). Al Mann said the same thing years ago, but I don't think many people understand it to this day. It's such a shame, but I get the feeling that you can understand it if well explained. Hope I did a good enough job. As a PWD, I really wish that you (and lots of others) would try this for yourselves. I think that you would find yourself feeling a lot better, thus realizing how bad you really were feeling. Matt-down-under pointed out the time in range aspect before. Mike C. has mentioned it so I have a bit more confidence in him because he saw the point. In spite of the r/s, it was refreshing to hear the executives getting awfully close to admitting how much corruption is standing in the way. I like how someone else on the board pointed out the old Intel bundling case. There sure are a lot of costly battles ahead. Didn't Warren Buffet get rich off insurance? Didn't Albert Einstein say that compound interest was the most powerful force in the Universe? Yes, staggering. I agree. The insurers love the staggering profits, but not so much spending on patients. Al Mann's concern was that if something was not done to fix the status quo, the system (Global Economy) would fail due to uncontrolled long-term costs from poor medical outcomes due to the trajectory of PWD (400+ million and growing). I wouldn't argue with much of this. Why don't more PWD try it? For the people I have talked to (almost entirely Type1) the biggest objection is that things work OK for them now so why change. Most agreed that things could be better but they didn't want to risk changing. Drilling down a lot of that seems to be about routine - I know how this works and I really don't want to start again. Social media isn't going to work. One of the issues with diabetes is that what works for one person doesn't necessarily work for another (I really wish the medical community understood that - don't get me started) so the assumption I hear is that the people on social media are those for whom this works. You get a similar effect from the low carb/high fat diet people in the Type 2 community. Diabetics tend to get a bit evangelical about things that work from them so other diabetics discount a lot of what they hear. Then the medical community, well the endos in New York, seem to vary between slightly negative and hostile. If you are a diabetic you need your endo to be positive because this is life threatening and you are currently safe even if it isn't optimal. That assurance had better be there. It's what happened when RAA was introduced - the results from the trials were compelling and the endos pushed it heavily. Finally there is the cost. Health systems can not afford to forgo Metformin, the costs will simply crush them. If they did move to earlier use of insulin it is more likely health systems revert to NPH and Regular than that they move forwards, it may be their only option. The trial otherottowaguy flagged used Regular rather than RAA. for example.
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Post by Deleted on Feb 2, 2017 18:10:50 GMT -5
The reply from MannKind:
"I will have my local rep try to get into the office tomorrow to share our T2 study along with discussion on MannKind Cares to help push the Rx through the plan."
My coworker's appointment is Monday, I will update on Tuesday.
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Post by agedhippie on Feb 2, 2017 18:33:45 GMT -5
Explaining to T2 coworkers of the benefits of Afrezza versus metformin is relatively easy, however, because our insurance currently does not cover Afrezza it is difficult for them to make the switch. Are there papers that spell out compelling reasons to switch? The only thing that would convince an insurance company is a trial demonstrating that afrezza use resulted in superior clinical outcomes versus use of metformin. So far, MNKD doesn't appear capable of getting even the almost trivial phase 1 pediatric trial off the ground, so what hope would there be for a afrezza versus metformin trial? Also consider that metformin recently been garnering a great deal of favorable press regarding its ability to inhibit the development of certain cancers. I recall that pancreatic cancer was one where it reduced the risk. And they're even using it to treat cancer now. Who wouldn't want to reduce the risk of cancer while controlling their diabetes? Metformin is protective against a lot of cancers. The ones I knew about were breast and colon cancer but it appears to be a lot wider. From the MDAnderson Cancer Center - Metformin May Have Broad Utility in Cancer.
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Post by sophie on Feb 2, 2017 19:29:03 GMT -5
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