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Post by novafett on Feb 10, 2017 9:26:42 GMT -5
All i think about when i hear all of the restrictions and how MNKD can't say stuff is all the adds i see for drugs that have 9M warnings about the side effects. When i hear it i think, how can people even consider this stuff, yet there it is on TV and i'm sure lots of people are hearing it and enough are buying it. <headscratch>
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Post by mango on Feb 10, 2017 9:57:00 GMT -5
AFREZZA's performance is second only to the function of a healthy human pancreas.No other drug can make that claim! Add to that, Non diabetic A1C's !!Those statements alone can and will spark interest in AFREZZA. But not if you keep it a secret! Two plus years after approval, and still no active sales promotion?? It just does not make sense! Come on MNKD! Those statements alone will get you into serious trouble with the FDA. I don't understand why people keep thinking we are advertising consumer goods here, these are drugs and advertising is heavily regulated. In foot high letters - You cannot make a claim in an advert that is unsupported by the label. End of story. Really? Well now, that is just simply not true sir agedhippie. Why act like it is so? • Sanofi has a "Proven 24 hour blood sugar control" claim represented by a graph showing a near perfect line with no lows or highs—yeah right, we know that is not true, and the FDA even addresses this below, but first, lets acknowledge another interesting tactic that Sanofi likes to use. • At the 1:11 mark, Sanofi deliberately tries to mask an important serious side effect that Toujeo has by "coupling" all insulins into the category with it. Nice try Sanofi, mango is on to you—" Insulins, including Toujeo, in combination with TZDs (thiazolidinediones) may cause serious side effects—like heart failure, that can lead to death. Even if you've never had heart failure before." • Well...okie dokie then. I just gotta laugh at that. Anyways, here is the video: m.youtube.com/watch?v=nNqcRVXu0lM• Sanofi gets a mere "warning letter" from the FDA for this commercial below, featuring, once again, you named it—TOUJEO as a the next best thing, second to apple pie of course. • Also, the "Proven 24 claim and graph is back, however, this time they add- AND beyond (the beyond part is literally in this video) blood sugar control claim with the same graph showing a nice line once again, with absolutely no lows or peaks. Lying to the consumer—yep. False advertising—yep. www.ispot.tv/ad/ArQh/toujeo-daily-groove-song-by-earth-wind-and-fire• According to this article about the FDA "warning letter", the FDA states that Toujeo's serious side effects are decreased or increased blood sugar, allergic reactions, and heart failure. • I of course love Sanofi's response: is "committed to working with the FDA to ensure...patients receive accurate and balanced information about our products". www.law360.com/articles/872684/fda-scolds-celgene-sanofi-for-cluttered-tv-ads• Wait a minute—but didn't Sanofi have in both of the commercials we reviewed above bold claims that Toujeo is PROVEN to control blood sugar for 24 hours AND beyond? Yep. A blatant lie. FDA missed this one. Mango did not. • Anyways—I could go on and on, but I'm about to have some RLS and daydream outside awhile. All MannKind needs to do is have a commercial that states: Managing diabetes without needles? Meet Afrezza. PROVEN to be the fastest INsulin and OUTsulin (with a nice graph of course) in town. Play the CC music and then show a few unforgettable scenes—a mountaineer hiking and simply reaching in his pocket taking a puff of human insulin (not man-made, genetically engineered in a lab insulin—This must also be represented somehow in the scenery of course, because it is, afterall, a fact), before he eats a snack, Spiro lounging in a pool puffing on Afrezza before helping heimself to some delicious gourmet treats by a mysterious woman, a couple at a romantic dinner with one of them taking a puff of human, none-lab grown insulin as the food arrives, a family about to eat a huge Thanksgiving meal and someone takes a puff of Afrezza, the non-lab wngineered insulin, before endulging in the goidness. THEN say—"Take a breath. Enjoy the freedom". And then go full commando on the warnings, blast them in huge bold print and even repeat some of them in slow-mo, who cares, because no one will get a flying **** because they just saw something they have never even imagined in their entire lives before. Simplicity...Freedom. Peace.
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Post by peppy on Feb 10, 2017 10:35:20 GMT -5
quote; A drug is "prescription only" when medical professionals must supervise its use because patients are not able to use the drug safely on their own.
Reply: I do not know any medical physician giving/ injecting or inserting/ setting up/filling and putting in the data on pumps for diabetics.
Diabetics ARE their own supervisors. And safety with subq fast acting insulin? what safety?
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Post by rravis1914 on Feb 10, 2017 11:09:15 GMT -5
Mango, Who are you? that was a very remarkable, comprehensive post. You seem to know what you are talking about and competent
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Post by Deleted on Feb 10, 2017 11:09:58 GMT -5
I don't even believe them that will be doing a TV ad.
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Post by johntherancher on Feb 10, 2017 12:03:01 GMT -5
Many of the posts under this topic have focused on what the FDA does not allow, and this is a justified concern IMO. But the FDA has laid out a series of rules to follow and whatever is produced by MNKD should make a reasonable effort to comply, again IMO. For guidelines see: www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/default.htmWith an attitude of general compliance I believe we should push ahead focusing on action instead of avoiding costs. The cost of error is spelled out by the FDA in the Q&A at their site, namely, "Many drug companies voluntarily seek advice from us before they release TV ads. However, if we believe that an ad violates the law, we send a letter to the drug company asking that the ads be stopped right away." No "bullets" are threatened for failure to comply, just that the FDA will ask "that the ads be stopped right away". Why do we hem and haw and quibble? Make our best effort and get on with letting PWD know about Afrezza.
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Post by sweedee79 on Feb 10, 2017 12:18:49 GMT -5
careful2investThe clinical trials for FDA approval only proved that Afrezza was non-inferior. I am unsure how MNKD is able to show that graph.. and I don't know that putting that graph in a TV commercial would be very meaningful to patients.. it certainly hasn't convinced Endos or docs.. We need to prove that Afrezza is superior in a clinical trial and get that on the label.. we need to clinically prove to the FDA that because Afrezza is faster and clears the system quicker that there is a very reduced risk of hypo .. and reduced weight gain.. all of this needs to be proven to the FDA with clinical trials before we can flat out claim it wish this would have been done in the original clinical trials but it wasn't ..
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Post by steve on Feb 10, 2017 12:46:39 GMT -5
Siraged hippie is aka oppie from the "other board" senior fud pumper.
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Post by kc on Feb 10, 2017 12:53:58 GMT -5
All i think about when i hear all of the restrictions and how MNKD can't say stuff is all the adds i see for drugs that have 9M warnings about the side effects. When i hear it i think, how can people even consider this stuff, yet there it is on TV and i'm sure lots of people are hearing it and enough are buying it. <headscratch> That is the problem with buying TV advertising. They have to according to the FDA list all the contradictions of taking the drug. It waste's a lot of valuable air time. MannKind would be smart to use Facebook advertising targeted to diabetics. That way the length of the ad could be whatever time it took to state the indications and contradictions. The have started that with some twitter ads and I would guess they will use some pay per clicks but they need a real advertisement campaign.
I also thought that they could do an infomercial on Afrezza, What its about, how to use it and also they contradictions. Infomercials could be purchased fairly cheaply on weird day parts on some cable networks. They don't have to have a high production value as much as just providing information. They also could have that infomercial on their web site and use for a pay click campaign. I am sure the cost to produce would be cheap and they don't have to get to overly technical.
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Post by zuegirdor on Feb 10, 2017 12:57:05 GMT -5
quote; A drug is "prescription only" when medical professionals must supervise its use because patients are not able to use the drug safely on their own.
Reply: I do not know any medical physician giving/ injecting or inserting/ setting up/filling and putting in the data on pumps for diabetics.
Diabetics ARE their own supervisors. And safety with subq fast acting insulin? what safety?
Everything you said. Peppy! The disconnect between prescription and physician involvement in treatment and reality IS HUGE! Patients manage their own risk and for better or worse the clinic has essentially little control over those risks. Otherwise there would be more "compliance" (wrong word since patients try their best with Gaussian distribution of results and outcomes). I can maybe understand controlling liquid insulin since it could be used for nefarious purposes (dont ask me to explain- you'd have to kill me if I told you)but.... But Afrezza could be sold from the shelves, and should be since it is totally customizable and no one is going to "accidentally" overdose an innocent bystander ala cloak and dagger mystery...
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Post by kc on Feb 10, 2017 13:08:28 GMT -5
quote; A drug is "prescription only" when medical professionals must supervise its use because patients are not able to use the drug safely on their own.
Reply: I do not know any medical physician giving/ injecting or inserting/ setting up/filling and putting in the data on pumps for diabetics.
Diabetics ARE their own supervisors. And safety with subq fast acting insulin? what safety?
Everything you said. Peppy! The disconnect between prescription and physician involvement in treatment and reality IS HUGE! Patients manage their own risk and for better or worse the clinic has essentially little control over those risks. Otherwise there would be more "compliance" (wrong word since patients try their best with Gaussian distribution of results and outcomes). I can maybe understand controlling liquid insulin since it could be used for nefarious purposes (dont ask me to explain- you'd have to kill me if I told you)but.... But Afrezza could be sold from the shelves, and should be since it is totally customizable and no one is going to "accidentally" overdose an innocent bystander ala cloak and dagger mystery...
Now that would be a novel idea Afrezza over they counter since its not an injectable insulin product.
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Post by steve on Feb 10, 2017 13:10:42 GMT -5
Those statements alone will get you into serious trouble with the FDA. I don't understand why people keep thinking we are advertising consumer goods here, these are drugs and advertising is heavily regulated. In foot high letters - You cannot make a claim in an advert that is unsupported by the label. End of story. Really? Well now, that is just simply not true sir agedhippie. Why act like it is so? • Sanofi has a "Proven 24 hour blood sugar control" claim represented by a graph showing a near perfect line with no lows or highs—yeah right, we know that is not true, and the FDA even addresses this below, but first, lets acknowledge another interesting tactic that Sanofi likes to use. • At the 1:11 mark, Sanofi deliberately tries to mask an important serious side effect that Toujeo has by "coupling" all insulins into the category with it. Nice try Sanofi, mango is on to you—" Insulins, including Toujeo, in combination with TZDs (thiazolidinediones) may cause serious side effects—like heart failure, that can lead to death. Even if you've never had heart failure before." • Well...okie dokie then. I just gotta laugh at that. Anyways, here is the video: m.youtube.com/watch?v=nNqcRVXu0lM• Sanofi gets a mere "warning letter" from the FDA for this commercial below, featuring, once again, you named it—TOUJEO as a the next best thing, second to apple pie of course. • Also, the "Proven 24 claim and graph is back, however, this time they add- AND beyond (the beyond part is literally in this video) blood sugar control claim with the same graph showing a nice line once again, with absolutely no lows or peaks. Lying to the consumer—yep. False advertising—yep. www.ispot.tv/ad/ArQh/toujeo-daily-groove-song-by-earth-wind-and-fire• According to this article about the FDA "warning letter", the FDA states that Toujeo's serious side effects are decreased or increased blood sugar, allergic reactions, and heart failure. • I of course love Sanofi's response: is "committed to working with the FDA to ensure...patients receive accurate and balanced information about our products". www.law360.com/articles/872684/fda-scolds-celgene-sanofi-for-cluttered-tv-ads• Wait a minute—but didn't Sanofi have in both of the commercials we reviewed above bold claims that Toujeo is PROVEN to control blood sugar for 24 hours AND beyond? Yep. A blatant lie. FDA missed this one. Mango did not. • Anyways—I could go on and on, but I'm about to have some RLS and daydream outside awhile. All MannKind needs to do is have a commercial that states: Managing diabetes without needles? Meet Afrezza. PROVEN to be the fastest INsulin and OUTsulin (with a nice graph of course) in town. Play the CC music and then show a few unforgettable scenes—a mountaineer hiking and simply reaching in his pocket taking a puff of human insulin (not man-made, genetically engineered in a lab insulin—This must also be represented somehow in the scenery of course, because it is, afterall, a fact), before he eats a snack, Spiro lounging in a pool puffing on Afrezza before helping heimself to some delicious gourmet treats by a mysterious woman, a couple at a romantic dinner with one of them taking a puff of human, none-lab grown insulin as the food arrives, a family about to eat a huge Thanksgiving meal and someone takes a puff of Afrezza, the non-lab wngineered insulin, before endulging in the goidness. THEN say—"Take a breath. Enjoy the freedom". And then go full commando on the warnings, blast them in huge bold print and even repeat some of them in slow-mo, who cares, because no one will get a flying **** because they just saw something they have never even imagined in their entire lives before. Simplicity...Freedom. Peace. Really nice post. Thanks.
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Post by johntherancher on Feb 10, 2017 13:11:24 GMT -5
Can we use the chart that the FDA produced in their Afrezza information package? I couldn't reproduce it here but it shows the pharmacodynamics of Afrezza pretty clearly. See Figure 3 at the FDA paper here: www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdfBoth A and B graphs in figure 3 show the insulin and outsulin features of Afrezza, IMO. Could we add comments pointing out what is clearly shown in the charts?
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Post by wgreystone on Feb 10, 2017 13:31:47 GMT -5
Ad opens in darkness with audible "click". Close-up of Jeffrey "The Dude" Lebowski in a bathrobe taking a hit on the Dreamboat. In a restaurant, courtroom, bathtub. "Hey man,I INHALED!" Waits 3s. Eyes go wide. "Wow that's fast!" Dark, quiet. "Click". Power chord played as stage lights come up to reveal Nick Jonas or Adam Lasher or Bret Michaels (Neil Young?) hitting the Dreamboat while holding power chord. "I INHALED!" Eyes go wide. "Wow that's fast!" Plays ripping high speed lick. I suspect those doctors just don't want to spend their "precious" time on dealing with the insurance issue. I had similar issue with another drug. When pharmacy called the doctor to fill up some forms, he simply changed the prescription to another drug. Need more VDEX clinics.
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Post by mango on Feb 10, 2017 13:32:57 GMT -5
Really? Well now, that is just simply not true sir agedhippie. Why act like it is so? • Sanofi has a "Proven 24 hour blood sugar control" claim represented by a graph showing a near perfect line with no lows or highs—yeah right, we know that is not true, and the FDA even addresses this below, but first, lets acknowledge another interesting tactic that Sanofi likes to use. • At the 1:11 mark, Sanofi deliberately tries to mask an important serious side effect that Toujeo has by "coupling" all insulins into the category with it. Nice try Sanofi, mango is on to you—" Insulins, including Toujeo, in combination with TZDs (thiazolidinediones) may cause serious side effects—like heart failure, that can lead to death. Even if you've never had heart failure before." • Well...okie dokie then. I just gotta laugh at that. Anyways, here is the video: m.youtube.com/watch?v=nNqcRVXu0lM• Sanofi gets a mere "warning letter" from the FDA for this commercial below, featuring, once again, you named it—TOUJEO as a the next best thing, second to apple pie of course. • Also, the "Proven 24 claim and graph is back, however, this time they add- AND beyond (the beyond part is literally in this video) blood sugar control claim with the same graph showing a nice line once again, with absolutely no lows or peaks. Lying to the consumer—yep. False advertising—yep. www.ispot.tv/ad/ArQh/toujeo-daily-groove-song-by-earth-wind-and-fire• According to this article about the FDA "warning letter", the FDA states that Toujeo's serious side effects are decreased or increased blood sugar, allergic reactions, and heart failure. • I of course love Sanofi's response: is "committed to working with the FDA to ensure...patients receive accurate and balanced information about our products". www.law360.com/articles/872684/fda-scolds-celgene-sanofi-for-cluttered-tv-ads• Wait a minute—but didn't Sanofi have in both of the commercials we reviewed above bold claims that Toujeo is PROVEN to control blood sugar for 24 hours AND beyond? Yep. A blatant lie. FDA missed this one. Mango did not. • Anyways—I could go on and on, but I'm about to have some RLS and daydream outside awhile. All MannKind needs to do is have a commercial that states: Managing diabetes without needles? Meet Afrezza. PROVEN to be the fastest INsulin and OUTsulin (with a nice graph of course) in town. Play the CC music and then show a few unforgettable scenes—a mountaineer hiking and simply reaching in his pocket taking a puff of human insulin (not man-made, genetically engineered in a lab insulin—This must also be represented somehow in the scenery of course, because it is, afterall, a fact), before he eats a snack, Spiro lounging in a pool puffing on Afrezza before helping heimself to some delicious gourmet treats by a mysterious woman, a couple at a romantic dinner with one of them taking a puff of human, none-lab grown insulin as the food arrives, a family about to eat a huge Thanksgiving meal and someone takes a puff of Afrezza, the non-lab wngineered insulin, before endulging in the goidness. THEN say—"Take a breath. Enjoy the freedom". And then go full commando on the warnings, blast them in huge bold print and even repeat some of them in slow-mo, who cares, because no one will get a flying **** because they just saw something they have never even imagined in their entire lives before. Simplicity...Freedom. Peace. Really nice post. Thanks. Nothing nice about my post. And I meant no offense to mr agedhippie, he just happened to the poster.
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