Articles and Media Spots - Original "Mega Thread"
Nov 22, 2014 20:43:54 GMT -5
spiro, nemzter, and 6 more like this
Post by ezrasfund on Nov 22, 2014 20:43:54 GMT -5
There is a great reply to AF's latest swipe at Afrezza on thestreet.com. It's good enough to copy and paste here for reference, as it hit all of the important points...
This quote from you totally proves you don't, won't or don't care to know the benefits of Afrezza.. "They care only about the price and risk-benefit of Afrezza relative to injectable meal-time insulin." Every take shots in a restaurant before meals?? Read The Reason Why It's Superior to RAA's out there today. You, Karp, Cramer, can keep trying to help your short pals, Your running out of time.
1. AFREZZA's Ultra Rapid Action is nearly an exact mirror to the endogenous post prandial insulin spike in a healthy non diabetic body, and as such it enters the body quickly and is active during the correct time frame to handle the meal time spike in blood sugar
2. As a physiologic meal time prandial insulin it is even more critical that it does its job and then rapidly exits the body without leaving behind a long insulin "tail" that leads to dangerous drops in blood sugar/hypoglycemic events, and insulin stacking problems. The currently available prandial insulin products, even the "rapid acting" insulins such as Humalog and Novolog are way too slow and linger for way too long after meal time digestion is over. This leads to these currently available insulins transitioning from prandial insulins to becoming "more basal" insulin. This effect does lower HbA1c levels making them appear more efficacious to the ignorant/uninitiated, but that IS NOT A GOOD THING (though the closed minded FDA staffers would have us believe otherwise)! HbA1c as a long term average is a very poor and incomplete statistical measure for quantifying how you are managing your diabetes. The trials for AFREZZA heavily relied on HbA1c endpoints whilst discounting more important measures such as fasting blood glucose levels, time spent in target range, leveling out blood sugar levels with higher lows and lower highs, reduced weight gain, less hypoglycemic events, etc...
3. Defensive snacking is largely eliminated with AFREZZA leading to weight loss, there is no longer a need to "feed the insulin" or face the risk of immediate coma or death.
4. Complex mealtime titration is not necessary due to the PK/PD of AFREZZA. This is huge for patient convenience and compliance
5. Constant finger pricks for blood glucose monitor testing is greatly reduced due to the PK/PD of AFREZZA. THIS IS A HUGE BENEFIT that the FDA has completely ignored. This is yet another way that the real world use of AFREZZA helps the patient move away from being a human pin cushion!
6. AFREZZA has absolutely zero side effects for the vast majority of patients, and very very minor side effects for a tiny minority of patients, such as a minor cough that quickly goes away as you adjust to inhaling the medicine. This drug is very safe, and very effective. In fact AFREZZA will be one of the safest and most effective drugs the FDA will ever approve.
7. AFREZZA will be (by orders of magnitude) the best insulin product on the market for making between meal adjustments for all diabetics across the spectrum of the disease. Currently available prandial insulins are far too slow. AFREZZA allows us to live in real time for the first time. Even patients who choose not to use AFREZZA as their everyday bolus, will NEED to have this product at their disposal for just this reason.
8. AFREZZA is the only prandial insulin with the Ultra Rapid Action needed to close the loop for the artificial pancreas. It's the missing piece that allows this project to move forward.
9. The unique and novel PK/PD of AFREZZA allows the patient to know their blood sugar levels are safe when they go to bed and not fear dying in their sleep as occurs with currently available products.
10. Patients on AFREZZA have far less blood sugar extreme highs and lows which lead to a myriad of health problems: blindness, organ failure, amputation, coma, death.
11. AFREZZA will be the first and only Ultra Rapid Acting insulin.
12. AFREZZA is easy for anyone to use, even the elderly and young children. The device is a marvel of modern design, small, efficient, and effective. Simple to use, inexpensive and disposable, few moving parts, you don't even have to break it down and clean it! This is exactly the type of revolutionary product that the FDA needs to make available to the public
13. Approval of AFREZZA opens up the Technosphere drug/device platform for pharma development for many other innovative products to come such as pain relief medicines and vaccines. This is the type of innovation that the United States needs to remain the world leader for, lest we by surpassed by companies in other countries, and we are forced to watch the United States take a back seat.
14. AFREZZA breaks down every barrier that physicians and patients face in initiating insulin therapy: 1. Needles, 2, Weight Gain, 3. Fear of Hypoglycemic Events, 4. Complicated Educational Process, 5. Gaining Patient Compliance
15. Research indicates that AFREZZA slows the progression of the disease. More studies are necessary for a final verdict, but wow--what a benefit!
This quote from you totally proves you don't, won't or don't care to know the benefits of Afrezza.. "They care only about the price and risk-benefit of Afrezza relative to injectable meal-time insulin." Every take shots in a restaurant before meals?? Read The Reason Why It's Superior to RAA's out there today. You, Karp, Cramer, can keep trying to help your short pals, Your running out of time.
1. AFREZZA's Ultra Rapid Action is nearly an exact mirror to the endogenous post prandial insulin spike in a healthy non diabetic body, and as such it enters the body quickly and is active during the correct time frame to handle the meal time spike in blood sugar
2. As a physiologic meal time prandial insulin it is even more critical that it does its job and then rapidly exits the body without leaving behind a long insulin "tail" that leads to dangerous drops in blood sugar/hypoglycemic events, and insulin stacking problems. The currently available prandial insulin products, even the "rapid acting" insulins such as Humalog and Novolog are way too slow and linger for way too long after meal time digestion is over. This leads to these currently available insulins transitioning from prandial insulins to becoming "more basal" insulin. This effect does lower HbA1c levels making them appear more efficacious to the ignorant/uninitiated, but that IS NOT A GOOD THING (though the closed minded FDA staffers would have us believe otherwise)! HbA1c as a long term average is a very poor and incomplete statistical measure for quantifying how you are managing your diabetes. The trials for AFREZZA heavily relied on HbA1c endpoints whilst discounting more important measures such as fasting blood glucose levels, time spent in target range, leveling out blood sugar levels with higher lows and lower highs, reduced weight gain, less hypoglycemic events, etc...
3. Defensive snacking is largely eliminated with AFREZZA leading to weight loss, there is no longer a need to "feed the insulin" or face the risk of immediate coma or death.
4. Complex mealtime titration is not necessary due to the PK/PD of AFREZZA. This is huge for patient convenience and compliance
5. Constant finger pricks for blood glucose monitor testing is greatly reduced due to the PK/PD of AFREZZA. THIS IS A HUGE BENEFIT that the FDA has completely ignored. This is yet another way that the real world use of AFREZZA helps the patient move away from being a human pin cushion!
6. AFREZZA has absolutely zero side effects for the vast majority of patients, and very very minor side effects for a tiny minority of patients, such as a minor cough that quickly goes away as you adjust to inhaling the medicine. This drug is very safe, and very effective. In fact AFREZZA will be one of the safest and most effective drugs the FDA will ever approve.
7. AFREZZA will be (by orders of magnitude) the best insulin product on the market for making between meal adjustments for all diabetics across the spectrum of the disease. Currently available prandial insulins are far too slow. AFREZZA allows us to live in real time for the first time. Even patients who choose not to use AFREZZA as their everyday bolus, will NEED to have this product at their disposal for just this reason.
8. AFREZZA is the only prandial insulin with the Ultra Rapid Action needed to close the loop for the artificial pancreas. It's the missing piece that allows this project to move forward.
9. The unique and novel PK/PD of AFREZZA allows the patient to know their blood sugar levels are safe when they go to bed and not fear dying in their sleep as occurs with currently available products.
10. Patients on AFREZZA have far less blood sugar extreme highs and lows which lead to a myriad of health problems: blindness, organ failure, amputation, coma, death.
11. AFREZZA will be the first and only Ultra Rapid Acting insulin.
12. AFREZZA is easy for anyone to use, even the elderly and young children. The device is a marvel of modern design, small, efficient, and effective. Simple to use, inexpensive and disposable, few moving parts, you don't even have to break it down and clean it! This is exactly the type of revolutionary product that the FDA needs to make available to the public
13. Approval of AFREZZA opens up the Technosphere drug/device platform for pharma development for many other innovative products to come such as pain relief medicines and vaccines. This is the type of innovation that the United States needs to remain the world leader for, lest we by surpassed by companies in other countries, and we are forced to watch the United States take a back seat.
14. AFREZZA breaks down every barrier that physicians and patients face in initiating insulin therapy: 1. Needles, 2, Weight Gain, 3. Fear of Hypoglycemic Events, 4. Complicated Educational Process, 5. Gaining Patient Compliance
15. Research indicates that AFREZZA slows the progression of the disease. More studies are necessary for a final verdict, but wow--what a benefit!