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Post by myocat on Sept 4, 2021 9:57:00 GMT -5
This is my second time meeting someone with T1 and they never heard of Afrezza.
I had to tell the individual about Afrezza.
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Post by prcgorman2 on Sept 4, 2021 10:41:09 GMT -5
With controlled substances, you can’t sell what isn’t prescribed. Direct To Consumer (DTC) advertising has been tried more than once, including pretty broad application of TV advertising (with a stupid flying hamburger theme that somehow managed an award). It’s marked lack of success proved it would be an ineffective way to market Afrezza unless there was prescriber acceptance which is still lacking.
Endocrinologists are the Subject Matter Experts when it comes to treating diabetes. There’s about 4,000 of them in the U.S. Not all of them have patients. Many Endos work for BP companies. There are over 225,000 Primary Care Physicians (PCPs) in the US who by-and-large take advice on treating persons with diabetes from Endos. If the Endos aren’t sold on your diabetes treatment product, you aren’t going to sell much of it.
The way to convince the Endos is with data. The expletive-deleted trials required by the FDA using a protocol negotiated with the FDA thanks to Martin Shkreli and whatever other skullduggery was going on with the then FDA director and her hedge fund husband, were simply awful and clearly designed to show Afrezza as “non-inferior” instead of “clearly superior”. Add in the Sanofi perfidy, and you have the perfect storm of the best prandial insulin on the market with nobody to sell it and an expensive and time-consuming lack of data with which to convince Endos.
Shortly after the recent round of brilliant corporate financing (thanks to MNKD management), Mannkind filed paperwork with the FDA for conducting the sort of trial that should have been done 6 years ago by Sanofi. COVID could delay things as it has so many other things so many times, but assuming the trial is able to be conducted, concluded, produces the results that are expected, approved by the FDA, published and discussed ad infinitum ad nauseum, the needle(s) should move. Assuming that by that time MNKD is already CFBE and still enjoying good corporate financing, THEN should begin the full-court press to negotiate Pharmacy Branch Manager (PBM) bribes, er, I mean discounts on Afrezza, and full-on DTC advertising and a dramatic increase in shoe leather (salespeople) and concomitant increase in diabetes educators and other operations personnel backing up the salesforce.
If you’re thinking this will take years, you are correct. Is it worth it? Afrezza is provably better than Novolog and Humalog. CGMs will prove it. Take a look at how much money is spent on Humalog and Novolog and imagine Mannkind getting half of it, or more. That’s the prize.
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Post by sr71 on Sept 4, 2021 11:52:08 GMT -5
With controlled substances, you can’t sell what isn’t prescribed. Direct To Consumer (DTC) advertising has been tried more than once, including pretty broad application of TV advertising (with a stupid flying hamburger theme that somehow managed an award). It’s marked lack of success proved it would be an ineffective way to market Afrezza unless there was prescriber acceptance which is still lacking. Endocrinologists are the Subject Matter Experts when it comes to treating diabetes. There’s about 4,000 of them in the U.S. Not all of them have patients. Many Endos work for BP companies. There are over 225,000 Primary Care Physicians (PCPs) in the US who by-and-large take advice on treating persons with diabetes from Endos. If the Endos aren’t sold on your diabetes treatment product, you aren’t going to sell much of it. The way to convince the Endos is with data. The expletive-deleted trials required by the FDA using a protocol negotiated with the FDA thanks to Martin Shkreli and whatever other skullduggery was going on with the then FDA director and her hedge fund husband, were simply awful and clearly designed to show Afrezza as “non-inferior” instead of “clearly superior”. Add in the Sanofi perfidy, and you have the perfect storm of the best prandial insulin on the market with nobody to sell it and an expensive and time-consuming lack of data with which to convince Endos. Shortly after the recent round of brilliant corporate financing (thanks to MNKD management), Mannkind filed paperwork with the FDA for conducting the sort of trial that should have been done 6 years ago by Sanofi. COVID could delay things as it has so many other things so many times, but assuming the trial is able to be conducted, concluded, produces the results that are expected, approved by the FDA, published and discussed ad infinitum ad nauseum, the needle(s) should move. Assuming that by that time MNKD is already CFBE and still enjoying good corporate financing, THEN should begin the full-court press to negotiate Pharmacy Branch Manager (PBM) bribes, er, I mean discounts on Afrezza, and full-on DTC advertising and a dramatic increase in shoe leather (salespeople) and concomitant increase in diabetes educators and other operations personnel backing up the salesforce. If you’re thinking this will take years, you are correct. Is it worth it? Afrezza is provably better than Novolog and Humalog. CGMs will prove it. Take a look at how much money is spent on Humalog and Novolog and imagine Mannkind getting half of it, or more. That’s the prize. I give you a thumbs-up for the excellent post. However, I would consider it socially desirable for Mannkind to somehow avoid the PBM corruption quagmire altogether (see bolded text above). Instead, I'd like to see efforts in: 1. Marketing the cash-pay Eagle Pharmacy route (see #4 below). 2. Partnering with VDEX to provide doctor training on the VDEX protocols, in exchange for a Mannkind rebate paid to VDEX for each Afrezza filled prescription written by those doctors (and their practices).
3. Publishing preliminary pediatric study data on an ongoing basis during the very long, one year trial. And forget about the ADA - they cater only to the big pharma crowd, as evidenced by the ineffectiveness of former CMO David Kendall to influence.
4. Providing weekly Mannkind news releases. Frequent publicity would do worlds of good to raise awareness that Mannkind product(s) exist and are effective. Hire a top-notch publicist to handle that task.
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Post by sportsrancho on Sept 4, 2021 18:25:04 GMT -5
Also… One key piece missing: you can’t use Afrezza as the ADA directs that prandial insulin’s should be used. If docs use that way it’ll be better than current but not so game-changing. Afrezza shines when used first and alone. That is a paradigm shift like the Fosbury Flop was to high jumping.
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Post by sweedee79 on Sept 4, 2021 21:32:26 GMT -5
I agree Sports and more than that the body responds to Afrezza in a way that it doesn't to the fake stuff... Yet we have no large trial data to prove all of this.. and many years later we continue to spin our wheels.. and actually do damage due to the patients we lose..
Until Mike addresses all of this, the situation remains the same... Years lost..
SOC doesn't require tight normal control... Only below 7.. We are ahead of our time.. Endos don't see the benefits.. or the need to change.. and it seems we are quite a bit more expensive.. another problem..
We need to be realistic and face the real issues.. dosing...SOC.. cost.. insurance... Etc etc.. noninferior label.. there you have it!!!
Know many will argue, but I've seen it first hand!! This is my story And I'm sticking to it cuz I know it's the truth.!! We fought long and hard to get and keep dad on Afrezza.. Even the Endos were ignorant about it and wanted nothing to do with tight control or even better control.. SCARED to death of hypo.. didn't want to deal with it.. didn't have to..7 was fine with them.. we are ahead of our time.. end of story!!
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Post by akemp3000 on Sept 5, 2021 5:14:20 GMT -5
I've been mentioning Afrezza for years to my PCP. He first said, he'd look into it. Lately though, he finally came clean and said look, "all of us doctors have been taught in school that prescribing insulin must be the last resort because it can cause hypos and injure or kill you. I will never prescribe insulin until the last resort". I of course, would change doctors when and if diagnosed as diabetic.
IMO, when endos, pcps and others hear the results of the forthcoming pediatric trials and approval by the FDA...simultaneously with the coming results of CGM usage, the game will turn in Mannkind's favor. Expensive promotions or management talking about it continuously at healthcare events won't change what doctors have been taught, at least not to a significance in market share. Our day is coming.
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Post by goyocafe on Sept 5, 2021 6:24:25 GMT -5
I've been mentioning Afrezza for years to my PCP. He first said, he'd look into it. Lately though, he finally came clean and said look, "all of us doctors have been taught in school that prescribing insulin must be the last resort because it can cause hypos and injure or kill you. I will never prescribe insulin until the last resort". I of course, would change doctors when and if diagnosed as diabetic. IMO, when endos, pcps and others hear the results of the forthcoming pediatric trials and approval by the FDA...simultaneously with the coming results of CGM usage, the game will turn in Mannkind's favor. Expensive promotions or management talking about it continuously at healthcare events won't change what doctors have been taught, at least not to a significance in market share. Our day is coming. Perhaps after all these years and when the tide finally changes you’ll take a few minutes to learn to spell and say the name correctly. 😁 |
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Post by sportsrancho on Sept 5, 2021 7:03:50 GMT -5
If they don’t study the science they won’t understand the less risk of hypo.
This is why we have to train our own providers, if you want to work for us you follow the protocols. The results of this training is pure amazement!
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Post by akemp3000 on Sept 5, 2021 7:18:15 GMT -5
I've been mentioning Afrezza for years to my PCP. He first said, he'd look into it. Lately though, he finally came clean and said look, "all of us doctors have been taught in school that prescribing insulin must be the last resort because it can cause hypos and injure or kill you. I will never prescribe insulin until the last resort". I of course, would change doctors when and if diagnosed as diabetic. IMO, when endos, pcps and others hear the results of the forthcoming pediatric trials and approval by the FDA...simultaneously with the coming results of CGM usage, the game will turn in Mannkind's favor. Expensive promotions or management talking about it continuously at healthcare events won't change what doctors have been taught, at least not to a significance in market share. Our day is coming. Perhaps after all these years and when the tide finally changes you’ll take a few minutes to learn to spell and say the name correctly. 😁 It was pre-coffee  |
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Post by prcgorman2 on Sept 5, 2021 8:32:22 GMT -5
I've been mentioning Afrezza for years to my PCP. He first said, he'd look into it. Lately though, he finally came clean and said look, "all of us doctors have been taught in school that prescribing insulin must be the last resort because it can cause hypos and injure or kill you. I will never prescribe insulin until the last resort". I of course, would change doctors when and if diagnosed as diabetic. IMO, when endos, pcps and others hear the results of the forthcoming pediatric trials and approval by the FDA...simultaneously with the coming results of CGM usage, the game will turn in Mannkind's favor. Expensive promotions or management talking about it continuously at healthcare events won't change what doctors have been taught, at least not to a significance in market share. Our day is coming. I’m glad your doctor came clean and stopped trying to placate you. I had assumed that this is exactly what doctors were taught but your post is the first candid admission I’ve seen. I knew there was significant concern because you’re giving a vial of liquid hormone to someone and saying “inject yourself with this several times a day, but try not over do it because it can and sometimes does kill the patient”. That’s a terrifying thing for a doctor. And, it is why I was convinced that the #1 thing to get from a trial and shout from the rooftops was the SAFETY of Afrezza as compared to injectible RAA insulins. SAFETY is why CGMs are going to be so important. The Freestyle Libre commercial that’s been running recently is helpful in that it shows a CGM patient being comfortable and confident regarding how to dose for a meal. If we can ever get a commercial that shows an Afrezza patient able to see a blood glucose spike and stop it in it’s tracks with a dose of Afrezza the way a pancreas does the same thing, that will be a powerful marketing message. |
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Post by longliner on Sept 5, 2021 10:07:51 GMT -5
I've been mentioning Afrezza for years to my PCP. He first said, he'd look into it. Lately though, he finally came clean and said look, "all of us doctors have been taught in school that prescribing insulin must be the last resort because it can cause hypos and injure or kill you. I will never prescribe insulin until the last resort". I of course, would change doctors when and if diagnosed as diabetic. IMO, when endos, pcps and others hear the results of the forthcoming pediatric trials and approval by the FDA...simultaneously with the coming results of CGM usage, the game will turn in Mannkind's favor. Expensive promotions or management talking about it continuously at healthcare events won't change what doctors have been taught, at least not to a significance in market share. Our day is coming. I’m glad your doctor came clean and stopped trying to placate you. I had assumed that this is exactly what doctors were taught but your post is the first candid admission I’ve seen. I knew there was significant concern because you’re giving a vial of liquid hormone to someone and saying “inject yourself with this several times a day, but try not over do it because it can and sometimes does kill the patient”. That’s a terrifying thing for a doctor. And, it is why I was convinced that the #1 thing to get from a trial and shout from the rooftops was the SAFETY of Afrezza as compared to injectible RAA insulins. SAFETY is why CGMs are going to be so important. The Freestyle Libre commercial that’s been running recently is helpful in that it shows a CGM patient being comfortable and confident regarding how to dose for a meal. If we can ever get a commercial that shows an Afrezza patient able to see a blood glucose spike and stop it in it’s tracks with a dose of Afrezza the way a pancreas does the same thing, that will be a powerful marketing message. The paradigm shift needs to occur before patent expiration....I believe Al Mann gave a speech regarding this very problem. High pricing is needed to recoup R & D costs before generics seize the day. It reminds me of the book "The Red Queen". |
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Post by sportsrancho on Sept 5, 2021 10:24:12 GMT -5
“SAFETY is why CGMs are going to be so important. The Freestyle Libre commercial that’s been running recently is helpful in that it shows a CGM patient being comfortable and confident regarding how to dose for a meal. If we can ever get a commercial that shows an Afrezza patient able to see a blood glucose spike and stop it in it’s tracks with a dose of Afrezza the way a pancreas does the same thing, that will be a powerful marketing message.”
Prc👍🏻 I’ve seen it and yes that’s that we need also.
And with kids 👏🏻🤸♂️
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Post by sportsrancho on Sept 5, 2021 10:56:39 GMT -5
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Post by agedhippie on Sept 5, 2021 14:07:56 GMT -5
I am going to have a little rant about the Libre here.
In fairness I am using the 14 day Libre and not the Libre 2 (there is no Android app for the US because of the %#$@ FDA), and the Libre 2 is meant to be more accurate, with the Libre 3 more accurate still when it eventually gets here. Frankly, for me it's a dumpster fire and I would never recommend it. The big problem with the Libre is that it cannot be calibrated so if it's off to start with then it remains off for the duration. We are not talking about a couple of points off, but more like 20% to 50% off which makes it useless for dosing from. If your levels are in the 80s then it's quite possible to get LO reading off the Libre which means when you are in the range you want to be in it won't report values.
If it's that bad why do I bother using it at all (and what happened to my Dexcom?) What the Libre does do is show you the curve. The numbers are garbage, but the curve is ok so you can spot trends and try to deal with them. Things used to be so much easier back when my insurer would cover Dexcom and I could use xDrip...
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Post by akemp3000 on Sept 5, 2021 14:49:51 GMT -5
Speaking of marketing and overcoming doctors concerns with risk, I can't imagine anything more powerful than print and TV ads showing a happy child with Afrezza once its approved for pediatrics. I could understand management delaying a push while waiting for this opportunity.
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