Three Standards of the Diabetes Industry are about to FALL..

[akemp3000]

Modern science is proving traditional standards of care for diabetics are dated, insufficient and have not produced the desired results:

1. A1c measures blood glucose average over three months. This will be replaced with real-time monitoring for significantly advanced and improved BG control.

2. METFORMIN is the initial standard of care prescribed for T2 diabetics. This drug tricks the body into lowering blood sugar but does not address the foundational problem of damaged beta cells and because of this has damaging, long-term side effects. AFREZZA actually provides the needed human insulin that more accurately addresses the underlying problem with fewer side effects and faster results.

3. INSURANCE COVERAGE is currently based on A1c results because science and the medical community has provided nothing better, at least until now. CGMs and countless tests currently underway will soon provide “results based” proof of reason to change standards of care and therefore insurance coverage.

Industry paradigm shifts don’t happen quickly. The important question is, how long will it take the medical community and insurance industry to acknowledge modern science and help diabetics? An analogy can be found in the building construction industry. Facts learned in building science laboratories today will be introduced in new building codes about five years from now. It will then take another five years before the new building codes are passed into local law, then accepted and enforced by local building code officials. These time frames are generalizations but the point is the same.

The paradigm shift for the standards of diabetes care has already begun. It’s time for the industry to catch up. Lives depend on it.

[centralcoastinvestor]

I think big tech players will help shift the industry faster than through just the medical community alone.  Players like Apple and Google with Bluetooth technology, advanced watches with internal CGMs, and One Drop apps will force the ADA to recognize that the A1c is no longer the appropriate benchmark to shoot for.  No matter what device tracks the blood glucose, Afrezza is the only insulin that can handle the new time in range requirements that are coming.  Unfortunately for us crazy long term shareholders, we have just recognized the upcoming shift before everyone else.  It means we have had to have a lot of tenacity to endure the anti change and short groups.  I do believe the tide is actually changing in our favor finally.

[zuegirdor]

Nov 20, 2017 14:27:53 GMT -5 akemp3000 said:

Modern science is proving traditional standards of care for diabetics are dated, insufficient and have not produced the desired results:

1. A1c measures blood glucose average over three months. This will be replaced with real-time monitoring for significantly advanced and improved BG control.

2. METFORMIN is the initial standard of care prescribed for T2 diabetics. This drug tricks the body into lowering blood sugar but does not address the foundational problem of damaged beta cells and because of this has damaging, long-term side effects. AFREZZA actually provides the needed human insulin that more accurately addresses the underlying problem with fewer side effects and faster results.

3. INSURANCE COVERAGE is currently based on A1c results because science and the medical community has provided nothing better, at least until now. CGMs and countless tests currently underway will soon provide “results based” proof of reason to change standards of care and therefore insurance coverage.

Industry paradigm shifts don’t happen quickly. The important question is, how long will it take the medical community and insurance industry to acknowledge modern science and help diabetics? An analogy can be found in the building construction industry. Facts learned in building science laboratories today will be introduced in new building codes about five years from now. It will then take another five years before the new building codes are passed into local law, then accepted and enforced by local building code officials. These time frames are generalizations but the point is the same.

The paradigm shift for the standards of diabetes care has already begun. It’s time for the industry to catch up. Lives depend on it.

Thanks so much for starting this thread. I hope there are counterpart discussions like this on medical blogs and other health professional forums with potential to influence actual standard development.

I agree with your first item, and with the spirit and intent of items 2 and 3. I think the standards can and will change, but I hope not at the same pace as building standards. As you say lives depend upon it. But that can be taken both as a rationale for speeding up the updating of standards and slowing down such change, ostensibly with the goal of patient safety paramount.

Another reason for slowing down change is to preserve "order and stability" in the drug production and drug/healthcare delivery system. The parentheses around order and stability are obviously referencing suspicion, common on the board and elsewhere, that entry of disruptive tech and innovation into drug markets will be delayed or altogether quashed to benefit existing markets for older drugs.

This is also a time of rapid change and innovation of markets. The first human subject of DNA editing, to treat Hunters Syndrome condition, was treated last week. This patient is being treated using gene insertion predating the more recent CRISPER technology. How soon until the first human subject using CRISPER-or CRISPER's successor?

It is a fact of life that, in this environment, at this time, virtuous innovators, well meaning regulators and perverse market actors all influence standard of care and treatment of disease. I may be cynical and out of my depth in saying; but, I think that, as you imply in item 2, Afrezza is the new heir apparent for the standard of care for type 2 diabetes. The studies to support that may not be quite ready; but those of us watching from the board probably are correct in assuming in won't be long until Afrezza's superiority is proven. However, in my opinion we would be wrong in assuming that Afrezza's superiority will make it the standard of care. The current standard of care for early detected cases of type 2 diabetes could just as easily be diet and exercise changes. the reason that metformin is first line is both that humans resist behavior modification and an inexpensive pill is an easier behavior fix.

Afrezza is easier than injecting and probably better for most people's health than metformin. Some users will just not want to change therapies or inhale their medicine, or have some other reason not to use a new product. But cost will be a key barrier to its promotion as a first line medication for Type 2 diabetics.

Cost is the largest source of drag on Afrezza's rise to the category of a first line or standard of care medication. Afrezza must rise to that level BEFORE THE NEXT DIABETES INNOVATION RENDERS AFREZZA OBSOLETE. The first strokes of that unfortunate rendering may begin within a very brief lapse of time, say 6 months(?); that is UNLESS the price of Afrezza is dropped to undercut the current price of the most popular RAA prandial injectables.

And it must also be mentioned that the current packaging of Afrezza is far less than ideal. The current packs are standardized to be equivalents to the famiar 1080 units per vial of liquid injectable that seemed to have worked for "most" diabetics. We have really little idea why that volume "worked" for most diabetics. No doubt it did not work for a lot of diabetics. Most probalby just adjusted their diets or exercise regimens, which is never a bad idea but, I would argue, nobody's business but but their own. Who tells my son's endo's that they cannot eat apple pie?

Every time my son eats a donut I know he will need at least 12u of Afrezza. Because we pay our of pocket for all of his Afrezza I know that means the fifty cent donut he just ate cost us $16 in insulin. And my son needs 2000 units of Afrezza a month.

I suspect that many other diabetics will also need as much insulin as my son. You wonder why script renewals dropped off in the past? Well it probably was, as the company has acknowledged, that titration is hard to figure out. What the company is either unaware of or not acknowledging is that the amount of Afrezza many patients need is well above what they were receiving from their Afrezza package prescriptions. They could not make the numbers work either with preconceptions based on other user reports and experiences, or the company guidance, with their budgets or with HMOs un-willing to encourage widespread adoption due to the foregoing cost and dose factors.

If we and the company want to see scripts go hyper drive, Mannkind will have to get a little more "liberal" it its pricing and dose volume size of its tiration AND packaging!

So as to item 3 on HMO adoption, you have to figure that, though the HMO's cost of providing insulin is lower than mine, they are very aware that how a person eats affects their bottom line in terms of insulin costs. Boom! A perverse incentive has just been created. And the real crime of it is, through no fault of my son's, another kid might only need 4 or 8 units of afrezza to eat that same donut. And all later stage type 2 diabetics may well need 16 or 20 units for my son's donut.

IMHO this all adds up to a somewhat negative forecast for widespread adoption of Afrezza. Dreaming about this promotion of Afrezza to the standard of care may keep us hopeful and committed to a great drug, but we should not kid ourselves. I don't know what Mannkind's internal plan and strategy recommends as price and dose targets are. I am pretty sure those plans will be ineffective if the package dose equivalent volutme is less than 2000 units and the price does not undercut the price for a 1080 vial of brand labeled prandial RAA injectable. I hope that Mannkind does not follow the lead of other phrmacuetical companies and price Afrezza based on some exclusionary model of adoption in the US or internationally. But even if they do, because cheaper, albeit nominally inferior insulins are already on the market, they should have the sense to bid low as newcomers, and implement the price maximization market research and pricing AFTER becoming firmly ensconced in the market via HMO's and doctor's practices through more liberal pricing and packaging.

[prosper]

Zue--It seems to me the solution is relatively simple.
After the first round, maybe two, on a titration or sample pack a user should know their needs.
Why can't MNKD offer "open stock" like Crate & Barrel glasses, in 12 or 24 cartridge of whatever dosage they want. The company would have to have some limits of how much how often, but that should be possible for their doctor to determine. Make it like a smorgasbord menu that the pharmacy could fill on an open stock basis per month.

[bill]

The analysis that needs to be done is the one that computes the average cost in health care for an individual properly dosed on Afrezza for the balance of their life expectancy versus the health care costs for an individual using less costly but less effective traditional drugs. This needs to be done for both T1s and T2s. If such an analysis could be done, I bet the results would overwhelmingly favor using Afrezza!

[agedhippie]

Nov 20, 2017 16:33:06 GMT -5 prosper said:

Zue--It seems to me the solution is relatively simple.
After the first round, maybe two, on a titration or sample pack a user should know their needs.
Why can't MNKD offer "open stock" like Crate & Barrel glasses, in 12 or 24 cartridge of whatever dosage they want. The company would have to have some limits of how much how often, but that should be possible for their doctor to determine. Make it like a smorgasbord menu that the pharmacy could fill on an open stock basis per month.

I bit the head off a Express Scripts pharmacist for going down that track (very satisfying - blood everywhere ). Prescribing insulin is problematic because you don't know how much you are going to use. The best case is that you take a guess based on past performance and add a percentage. PBMs absolutely hate that because it's imprecise and they are about reducing costs so they will arbitrarily reduce the quantity (hence the head biting episode) unless you phrase the prescription very carefully. 

[agedhippie]

Nov 20, 2017 16:53:45 GMT -5 bill said:

The analysis that needs to be done is the one that computes the average cost in health care for an individual properly dosed on Afrezza for the balance of their life expectancy versus the health care costs for an individual using less costly but less effective traditional drugs. This needs to be done for both T1s and T2s. If such an analysis could be done, I bet the results would overwhelmingly favor using Afrezza!

It may be overwhelmingly in favor over the long term, but insurers work in the short term. With T2 here are two possible outcomes for the insurer - either the complications catch you early in which case you end up out of work on Medicaid, or you make it to 65 and you become Medicare's problem. In neither case is there a reason why the insurer would be interested in your long term well being.

Now with socialized/single payer systems like the NHS the system has an interest in keeping you health because they always pick up the bill. The NHS pays a bounty to doctors for diabetes outcomes specifically because it has that long term view - they know they are on the hook for the life time costs and not just for five years or so.

[sayhey24]

The goal of the health insurer or self insured company is to get you to 65 and turned over to medicare. Now the incidence of heart attack or fatal coronary heart disease by age, sex, and race between the age of 45 to 64 is about the same as those 65 to 74.

Now we know your chance of a heart issue is about 3x higher for diabetics but if you add in the "pre-diabetics" between 6.0 to 7.0 A1c I bet its even higher.

Significantly reducing heart issues IMO is the biggest selling point to insurance companies as it should significantly reduce their costs and significantly increase their chance of getting these people to medicare. However afrezza cost is a huge hurdle in getting people to use it. This needs to be addressed asap.

[bill]

Nov 20, 2017 21:14:44 GMT -5 agedhippie said:

Nov 20, 2017 16:53:45 GMT -5 bill said:

The analysis that needs to be done is the one that computes the average cost in health care for an individual properly dosed on Afrezza for the balance of their life expectancy versus the health care costs for an individual using less costly but less effective traditional drugs. This needs to be done for both T1s and T2s. If such an analysis could be done, I bet the results would overwhelmingly favor using Afrezza!

It may be overwhelmingly in favor over the long term, but insurers work in the short term. With T2 here are two possible outcomes for the insurer - either the complications catch you early in which case you end up out of work on Medicaid, or you make it to 65 and you become Medicare's problem. In neither case is there a reason why the insurer would be interested in your long term well being.

Now with socialized/single payer systems like the NHS the system has an interest in keeping you health because they always pick up the bill. The NHS pays a bounty to doctors for diabetes outcomes specifically because it has that long term view - they know they are on the hook for the life time costs and not just for five years or so.

Everyone benefits if patients stay healthier. With people staying in the work force beyond 65, there's plenty of time for every insurance company to become more profitable by keeping their PWDs healthy with Afrezza! And, the more the industry embraces Afrezza, the lower the eventual cost will be for CGMs and Afrezza--increasing insurance company profits.

[kc]

Nov 20, 2017 21:39:23 GMT -5 sayhey24 said:

The goal of the health insurer or self insured company is to get you to 65 and turned over to medicare. Now the incidence of heart attack or fatal coronary heart disease by age, sex, and race between the age of 45 to 64 is about the same as those 65 to 74.

Now we know your chance of a heart issue is about 3x higher for diabetics but if you add in the "pre-diabetics" between 6.0 to 7.0 A1c I bet its even higher.

Significantly reducing heart issues IMO is the biggest selling point to insurance companies as it should significantly reduce their costs and significantly increase their chance of getting these people to medicare. However afrezza cost is a huge hurdle in getting people to use it. This needs to be addressed asap.

The outlook of the insurance company is even more short term it’s contract year to contract year. The renewal cycle is what they look at. What does it cost between those two periods for the insurance company. Keep the cost cheap cheap cheap and the insurance company makes a lot of money.

[sellhighdrinklow]

Nov 20, 2017 16:12:14 GMT -5 zuegirdor said:

Nov 20, 2017 14:27:53 GMT -5 akemp3000 said:

Modern science is proving traditional standards of care for diabetics are dated, insufficient and have not produced the desired results:

1. A1c measures blood glucose average over three months. This will be replaced with real-time monitoring for significantly advanced and improved BG control.

2. METFORMIN is the initial standard of care prescribed for T2 diabetics. This drug tricks the body into lowering blood sugar but does not address the foundational problem of damaged beta cells and because of this has damaging, long-term side effects. AFREZZA actually provides the needed human insulin that more accurately addresses the underlying problem with fewer side effects and faster results.

3. INSURANCE COVERAGE is currently based on A1c results because science and the medical community has provided nothing better, at least until now. CGMs and countless tests currently underway will soon provide “results based” proof of reason to change standards of care and therefore insurance coverage.

Industry paradigm shifts don’t happen quickly. The important question is, how long will it take the medical community and insurance industry to acknowledge modern science and help diabetics? An analogy can be found in the building construction industry. Facts learned in building science laboratories today will be introduced in new building codes about five years from now. It will then take another five years before the new building codes are passed into local law, then accepted and enforced by local building code officials. These time frames are generalizations but the point is the same.

The paradigm shift for the standards of diabetes care has already begun. It’s time for the industry to catch up. Lives depend on it.

Thanks so much for starting this thread. I hope there are counterpart discussions like this on medical blogs and other health professional forums with potential to influence actual standard development.

I agree with your first item, and with the spirit and intent of items 2 and 3. I think the standards can and will change, but I hope not at the same pace as building standards. As you say lives depend upon it. But that can be taken both as a rationale for speeding up the updating of standards and slowing down such change, ostensibly with the goal of patient safety paramount.

Another reason for slowing down change is to preserve "order and stability" in the drug production and drug/healthcare delivery system. The parentheses around order and stability are obviously referencing suspicion, common on the board and elsewhere, that entry of disruptive tech and innovation into drug markets will be delayed or altogether quashed to benefit existing markets for older drugs.

This is also a time of rapid change and innovation of markets. The first human subject of DNA editing, to treat Hunters Syndrome condition, was treated last week. This patient is being treated using gene insertion predating the more recent CRISPER technology. How soon until the first human subject using CRISPER-or CRISPER's successor?

It is a fact of life that, in this environment, at this time, virtuous innovators, well meaning regulators and perverse market actors all influence standard of care and treatment of disease. I may be cynical and out of my depth in saying; but, I think that, as you imply in item 2, Afrezza is the new heir apparent for the standard of care for type 2 diabetes. The studies to support that may not be quite ready; but those of us watching from the board probably are correct in assuming in won't be long until Afrezza's superiority is proven. However, in my opinion we would be wrong in assuming that Afrezza's superiority will make it the standard of care. The current standard of care for early detected cases of type 2 diabetes could just as easily be diet and exercise changes. the reason that metformin is first line is both that humans resist behavior modification and an inexpensive pill is an easier behavior fix.

Afrezza is easier than injecting and probably better for most people's health than metformin. Some users will just not want to change therapies or inhale their medicine, or have some other reason not to use a new product. But cost will be a key barrier to its promotion as a first line medication for Type 2 diabetics.

Cost is the largest source of drag on Afrezza's rise to the category of a first line or standard of care medication. Afrezza must rise to that level BEFORE THE NEXT DIABETES INNOVATION RENDERS AFREZZA OBSOLETE. The first strokes of that unfortunate rendering may begin within a very brief lapse of time, say 6 months(?); that is UNLESS the price of Afrezza is dropped to undercut the current price of the most popular RAA prandial injectables.

And it must also be mentioned that the current packaging of Afrezza is far less than ideal. The current packs are standardized to be equivalents to the famiar 1080 units per vial of liquid injectable that seemed to have worked for "most" diabetics. We have really little idea why that volume "worked" for most diabetics. No doubt it did not work for a lot of diabetics. Most probalby just adjusted their diets or exercise regimens, which is never a bad idea but, I would argue, nobody's business but but their own. Who tells my son's endo's that they cannot eat apple pie?

Every time my son eats a donut I know he will need at least 12u of Afrezza. Because we pay our of pocket for all of his Afrezza I know that means the fifty cent donut he just ate cost us $16 in insulin. And my son needs 2000 units of Afrezza a month.

I suspect that many other diabetics will also need as much insulin as my son. You wonder why script renewals dropped off in the past? Well it probably was, as the company has acknowledged, that titration is hard to figure out. What the company is either unaware of or not acknowledging is that the amount of Afrezza many patients need is well above what they were receiving from their Afrezza package prescriptions. They could not make the numbers work either with preconceptions based on other user reports and experiences, or the company guidance, with their budgets or with HMOs un-willing to encourage widespread adoption due to the foregoing cost and dose factors.

If we and the company want to see scripts go hyper drive, Mannkind will have to get a little more "liberal" it its pricing and dose volume size of its tiration AND packaging!

So as to item 3 on HMO adoption, you have to figure that, though the HMO's cost of providing insulin is lower than mine, they are very aware that how a person eats affects their bottom line in terms of insulin costs. Boom! A perverse incentive has just been created. And the real crime of it is, through no fault of my son's, another kid might only need 4 or 8 units of afrezza to eat that same donut. And all later stage type 2 diabetics may well need 16 or 20 units for my son's donut.

IMHO this all adds up to a somewhat negative forecast for widespread adoption of Afrezza. Dreaming about this promotion of Afrezza to the standard of care may keep us hopeful and committed to a great drug, but we should not kid ourselves. I don't know what Mannkind's internal plan and strategy recommends as price and dose targets are. I am pretty sure those plans will be ineffective if the package dose equivalent volutme is less than 2000 units and the price does not undercut the price for a 1080 vial of brand labeled prandial RAA injectable. I hope that Mannkind does not follow the lead of other phrmacuetical companies and price Afrezza based on some exclusionary model of adoption in the US or internationally. But even if they do, because cheaper, albeit nominally inferior insulins are already on the market, they should have the sense to bid low as newcomers, and implement the price maximization market research and pricing AFTER becoming firmly ensconced in the market via HMO's and doctor's practices through more liberal pricing and packaging.

Your son is a diabetic and therefore should NOT be eating a donut...or fried chicken....or french fries. Fried foods are a disaster for blood glucose levels. Fried foods with simple sugars involved is a multiplier of negatives.

Your son doesn't need donuts. No offense but those are just the facts. My two cents.

[sportsrancho]

Kids have to be kids once in a while. That’s one of the beauty’s of Afrezza.
But evidently it’s going to cost you for that doughnut:-)

[seanismorris]

DexCom (DXCM -0.9%) inks a development agreement with Eli Lilly (LLY +1.2%) to include Dexcom Continuous Glucose Monitoring (CGM) into Lilly's diabetes ecosystem. The companies plan to combine Lilly's smart insulin delivery devices and Dexcom CGM as a comprehensive solution to improve diabetes management. Clinical studies will being next month.

Financial terms are not disclosed.

[zuegirdor]

Nov 20, 2017 21:14:44 GMT -5 agedhippie said:

Nov 20, 2017 16:53:45 GMT -5 bill said:

The analysis that needs to be done is the one that computes the average cost in health care for an individual properly dosed on Afrezza for the balance of their life expectancy versus the health care costs for an individual using less costly but less effective traditional drugs. This needs to be done for both T1s and T2s. If such an analysis could be done, I bet the results would overwhelmingly favor using Afrezza!

It may be overwhelmingly in favor over the long term, but insurers work in the short term. With T2 here are two possible outcomes for the insurer - either the complications catch you early in which case you end up out of work on Medicaid, or you make it to 65 and you become Medicare's problem. In neither case is there a reason why the insurer would be interested in your long term well being.

Now with socialized/single payer systems like the NHS the system has an interest in keeping you health because they always pick up the bill. The NHS pays a bounty to doctors for diabetes outcomes specifically because it has that long term view - they know they are on the hook for the life time costs and not just for five years or so.

Well reasoned analysis on how appropriate regulation of health care markets and drug prices can financially benefit Mannkind and Afrezza users while dropping actual costs of disease management.

It should always pay more to do the RIGHT THING- and I believe it does pay more to act from that place. There is a whole sermon that goes with this; but I...

[zuegirdor]

Nov 21, 2017 9:09:10 GMT -5 sellhighdrinklow said:

Nov 20, 2017 16:12:14 GMT -5 zuegirdor said:

Thanks so much for starting this thread. I hope there are counterpart discussions like this on medical blogs and other health professional forums with potential to influence actual standard development.

I agree with your first item, and with the spirit and intent of items 2 and 3. I think the standards can and will change, but I hope not at the same pace as building standards. As you say lives depend upon it. But that can be taken both as a rationale for speeding up the updating of standards and slowing down such change, ostensibly with the goal of patient safety paramount.

Another reason for slowing down change is to preserve "order and stability" in the drug production and drug/healthcare delivery system. The parentheses around order and stability are obviously referencing suspicion, common on the board and elsewhere, that entry of disruptive tech and innovation into drug markets will be delayed or altogether quashed to benefit existing markets for older drugs.

This is also a time of rapid change and innovation of markets. The first human subject of DNA editing, to treat Hunters Syndrome condition, was treated last week. This patient is being treated using gene insertion predating the more recent CRISPER technology. How soon until the first human subject using CRISPER-or CRISPER's successor?

It is a fact of life that, in this environment, at this time, virtuous innovators, well meaning regulators and perverse market actors all influence standard of care and treatment of disease. I may be cynical and out of my depth in saying; but, I think that, as you imply in item 2, Afrezza is the new heir apparent for the standard of care for type 2 diabetes. The studies to support that may not be quite ready; but those of us watching from the board probably are correct in assuming in won't be long until Afrezza's superiority is proven. However, in my opinion we would be wrong in assuming that Afrezza's superiority will make it the standard of care. The current standard of care for early detected cases of type 2 diabetes could just as easily be diet and exercise changes. the reason that metformin is first line is both that humans resist behavior modification and an inexpensive pill is an easier behavior fix.

Afrezza is easier than injecting and probably better for most people's health than metformin. Some users will just not want to change therapies or inhale their medicine, or have some other reason not to use a new product. But cost will be a key barrier to its promotion as a first line medication for Type 2 diabetics.

Cost is the largest source of drag on Afrezza's rise to the category of a first line or standard of care medication. Afrezza must rise to that level BEFORE THE NEXT DIABETES INNOVATION RENDERS AFREZZA OBSOLETE. The first strokes of that unfortunate rendering may begin within a very brief lapse of time, say 6 months(?); that is UNLESS the price of Afrezza is dropped to undercut the current price of the most popular RAA prandial injectables.

And it must also be mentioned that the current packaging of Afrezza is far less than ideal. The current packs are standardized to be equivalents to the famiar 1080 units per vial of liquid injectable that seemed to have worked for "most" diabetics. We have really little idea why that volume "worked" for most diabetics. No doubt it did not work for a lot of diabetics. Most probalby just adjusted their diets or exercise regimens, which is never a bad idea but, I would argue, nobody's business but but their own. Who tells my son's endo's that they cannot eat apple pie?

Every time my son eats a donut I know he will need at least 12u of Afrezza. Because we pay our of pocket for all of his Afrezza I know that means the fifty cent donut he just ate cost us $16 in insulin. And my son needs 2000 units of Afrezza a month.

I suspect that many other diabetics will also need as much insulin as my son. You wonder why script renewals dropped off in the past? Well it probably was, as the company has acknowledged, that titration is hard to figure out. What the company is either unaware of or not acknowledging is that the amount of Afrezza many patients need is well above what they were receiving from their Afrezza package prescriptions. They could not make the numbers work either with preconceptions based on other user reports and experiences, or the company guidance, with their budgets or with HMOs un-willing to encourage widespread adoption due to the foregoing cost and dose factors.

If we and the company want to see scripts go hyper drive, Mannkind will have to get a little more "liberal" it its pricing and dose volume size of its tiration AND packaging!

So as to item 3 on HMO adoption, you have to figure that, though the HMO's cost of providing insulin is lower than mine, they are very aware that how a person eats affects their bottom line in terms of insulin costs. Boom! A perverse incentive has just been created. And the real crime of it is, through no fault of my son's, another kid might only need 4 or 8 units of afrezza to eat that same donut. And all later stage type 2 diabetics may well need 16 or 20 units for my son's donut.

IMHO this all adds up to a somewhat negative forecast for widespread adoption of Afrezza. Dreaming about this promotion of Afrezza to the standard of care may keep us hopeful and committed to a great drug, but we should not kid ourselves. I don't know what Mannkind's internal plan and strategy recommends as price and dose targets are. I am pretty sure those plans will be ineffective if the package dose equivalent volutme is less than 2000 units and the price does not undercut the price for a 1080 vial of brand labeled prandial RAA injectable. I hope that Mannkind does not follow the lead of other phrmacuetical companies and price Afrezza based on some exclusionary model of adoption in the US or internationally. But even if they do, because cheaper, albeit nominally inferior insulins are already on the market, they should have the sense to bid low as newcomers, and implement the price maximization market research and pricing AFTER becoming firmly ensconced in the market via HMO's and doctor's practices through more liberal pricing and packaging.

Your son is a diabetic and therefore should NOT be eating a donut...or fried chicken....or french fries. Fried foods are a disaster for blood glucose levels. Fried foods with simple sugars involved is a multiplier of negatives.

Your son doesn't need donuts. No offense but those are just the facts. My two cents.

I agree with your dietary advice. For three years he ate one donut every 6 months. That seems a reasonable rate even for non-diabetics. He eats a donut or two a month now.

I do worry about him developing bad habits. But it would be psychologically and developmentally appropriate for him to realize the importance of a healthy diet on his own terms. BTW there are plenty of diabetics not on Afrezza who are completely out of control - many eat donuts and many do not. The psychological burden on T1D patients is more deadly than most realize. Psychological well being is 60% of the reason we fought to get Afrezza for my son.

Perhaps I could have made the point about the cost to insurance companies of carb eating by diabetics by choosing a different food for my example: say bagels? Would you have reacted to my example the same way? Pork ribs, with all of the fat, are also quite costly for him to eat. Even diabetics on a ketogenic diet need insulin!

My main point is that keeping my son alive is ARBITRARILY expensive when you consider the manufacturing cost (plus a reasonable margin of say 40%?) for insulin, including Afrezza. The injustice lies in enforcing diet behavior, through insulin cost, only on this 1.5% of the population (T1Ds) but on no one else! This is economic bullying plain and simple. And that bullying is a function of the pricing model for insulin.

BTW, I understand that you meant no disrespect in offering your observation.