My first blog post on this topic was a compilation of doctor.stockpicker's posts on the MNKD Yahoo message board (YMB) between Jan. 06, 2015 and Feb. 11, 2015. This collection of posts made a good case for why Afrezza had a strong chance of becoming a blockbuster drug. It has been about four months since the first "collection" was released (:-) ), so I decided to capture the good doctor's wisdom in a second Instablog post. There is a lot of "junk" in YMB and I thought it would be useful for people like me who are long MNKD and fervently wish for Afrezza to succeed - and not just for my pocketbook but because I truly believe that this product makes a positive change in a diabetic's lifestyle and disease management.
Feb. 12, 2015:
On my SA Instablog compilation of his YMB posts
"Hey, I didn't see that coming but I definitely give it a thumb's up"
Feb. 12, 2015:
"I agree totally. I never prescribed it a single time"
Feb. 16, 2015:
"I've not had any problems.. There is no Medicare D coverage yet."
Feb. 16, 2015:
"Get a Microlife FEV1 meter and you can monitor your FEV1 and will see any subtle decline in your pulmonary status. If I was a dibetic with mild asthma, I would at least try Afrezza."
Feb. 17, 2015:
"I just looked at Afrezzauser's tweel about his CGM's calculated a1c. I've never seen anything like it. Heretofor, when I see patients with a a1c much below 7, I would get nervous as studies (google ACCCORD) have proven that low a1cs kill people. But he is is not having hypoglycemic events. Could the world be saying goodbye to diabetic retinopathy, nephropathy, neuropathy, vasculopathy, and gastropathy? At least for now, it appears that the very early evidence is that Alfred may have known what he was talking about all along."
Feb. 23, 2015:
"I concur. If I was a diabetic, I would take Afrezza"
Feb. 26, 2015:
"My Sanofi rep made it back to my office today with more discount cards and this time he had some 4 unit samples. He has now made the rounds to the physicians that Sanofi had him initially target. His take on the acceptance was that the primary care physicians where enthusiastic, but that the endocrinologists were hesitant because of the lack of unit by unit titration capabilities. He stated that a couple of them mentioned something about Exubera. That does not surprise me, because I had the same thoughts when I first read about another inhaled insulin.. Paradigm shifts are typically met with skepticism. It was only after extensive due diligence (almost to the point of a fanatical excess) that I came to the realization that Al is correct. The endocrinologists will come around in due time, just like I did. Like I told the rep today "my pancreas does not count carbs and adjust its insulin output as I start to eat."
Another thing, I find it very interesting that Afrezzauser decreased his basal insulin dose a a few days after he began Afrezza. I have tried to understand the exact mechanism of this phenomenon and I really don't know what it could be, but I suspect that it is a good thing for his overall health. I would like see study on measuring CRP in patients both before and after Afrezza initiation."
"There are no oral insulins. Insulins are proteins and would be digested it eaten. You need to delete your post."
"I think that Afrezza will eventually be prescribed to all diabetics that have no contraindications as they will benefit from a more normal first phase insulin response. Very few if any "controlled diabetics" actually are controlled to a nondiabetic a1c, therefore they are still being damaged from their disease. It is the prandial spike that has been referred to as the "prandial problem" that keeps them from having better A1Cs . Afrezza is the ideal medication for this problem."
I'm not aware of occasional use. But patients have a way of doing things their way. The big question that remains is should all type 2 diabetics take Afrezza with meals so the pancreas will no longer be stressed.. I had a patient today that actually called last week to see if he could get him in early to be started on Afrezza prior to leaving town. . We complied with his request. I was explaining to him how to use the product and his response was "what If I eat ten times a day?". Yes he is overweight . My response was "well, for now , just use it with you three biggest meals of the day". I do not what insurance companines will think about a patient having 4,8, and 12 unit cartridges to use with every snack and meal throughout the day."
Feb. 28, 2015:
"My Sanofi rep that details Afrezza is not going to detail Toujeo and stated that there will be different reps for the two products nationwide. He is quite happy that he got Afrezza instead of Toujeo. He also said Lantus will not be supported by Sanofi in the very near future. He personally thinks that Toujeo is the answer to a problem that does not exist."
Mar. 05, 2015:
"I'm going to explain why Afrezzauser and other diabetics can take Afrezza without a meal and not become hypoglycemic.
Why does a normal pancreas not need to count carbs. The pancreas has no way of knowing if you are going to eat a half a piece of pizza or the whole pizza followed a big bowl of ice cream. Now here is a simplified explanation of how this works.
Glucose is the main stimulator of insulin release from the pancreas. Insulin then exerts its main effect by binding to a cell surface receptor. This binding initiates a cascade of enzymatic processes that allow glucose to be transported into the cell by a group of specialized proteins called glucose transporters (GLUTs). GLUT4 is responsible for the insulin-stimulated glucose uptake in muscle and adipose tissue , thus the classic hypoglycemic action of insulin. There are many GLUTs in other tissues of the body and they are located on the cell surface, but GLUT4 is sequestered within vesicles within the cytoplasm. Insulin causes the vesicles to be translocated to the cell surface where their contained GLUT4 unit functions as a pore that allows passage of glucose into the cell. This process is reversible, so when insulin levels fall the GLUT4 is removed by endocytosis back into cell where it is again stored in the vesicles and therefore glucose is no longer taken into the cells.
The above described process means that the rate limiting step of glucose reduction is not the insulin itself , but on the number of insulin receptors on the cell membrane and on the number of GLUT4 units available to serve as pores for glucose to enter the cell. Once they are occupied, more insulin has nothing to act upon. The problem with prandial insulin shots is that have effects long enough for the GLUT4 and the insulin receptors to again become available to allow glucose transport into the cell when there is no longer the surge in glucose from the meal, therefore the patient becomes hypoglycemic."
"It is not pumping the stock, it is explaining the science of insulin and how Afrezza acts within the body. This stock is being bought and sold by people who do not understand the science. I suspect that you are one of them."
"My explanation was simplified and I don't profess to know everything about insulin and its metabolism, but I would think it would be better to take another smaller dose. Remember, there is only so many pores that can be opened to allow glucose transport into the cells. At a certain point a bigger dose of insulin will not open any more pores as they are maximally opened. We will learn this with time. The take home point is that counting carbs and adjusting insulin is not the key with Afrezza but the timing of Afrezza in relationship to the meal might be. Remember, some of the resistance to Afrezza is that people think that the lack of a unit by unit adjusting mechanism is a negative. My point is that a normal pancreas does not know how to count carbs and I tried to explain why that is the case."
Mar. 12, 2015:
"I think eventually the standard of care for treatment of type 2 diabetes will be both metformin and Afrezza.. Metformin will help the insulin resistance and is associated with the weight gain and Afrezza will handle the mealtime glucose spikes."
Mar. 14, 2015:
"I started medical school in 1981 and believe that the only bigger bigger medical breakthrough in my time has been statins. I was in postgraduate training when Mevacor was released and the physician community was as skeptical of it as they are now of Afrezza. But we learned their benefits slowly and we will all learn the benefits of Afrezza at what I predict will be a much quicker pace.
What Dr. Bode says means that Afrezza will capture the entirety of all of the prandial insulins, GLP agonists , DPP4 inhibitors, and TZDs. For a few years now, I thought all type 1 diabetics without contraindications would be treated with Afrezza and all type 2 diabetics would be treated with metformin and Afrezza, but I'm beginning to believe that the metformin is now superfluous.
I do not know what the market value for all of these classes of medications is , but it is a very large number. Al has known this all along and this is why he has not sold the company , nor will he until everyone knows what he knows.
Quit worrying, and quit wishing for a premature buyout and do as I am now going to do, that is, research for Cabo beach houses. One another piece of advise and make this your mantra. DO NOT SELL UNTIL THE WORLD KNOWS WHAT AL HAS KNOWN ALL ALONG"
"Also. remember the FDA required yearly opthalmological exams for Mevacor patients similar to the FEV1 surveillance for Afrezza"
"You may be correct. Maybe all any diabetic needs is human insulin delivered in a way that mimics the insulin release of a human pancreas, that is a basal insulin and a prandial insulin. It makes me wonder if the Lente and Ultralente insulins should be revisited as a basal insulin as they were human insulin. I briefly tried to find out some info on them prior to posting this, but I was unsuccessful. But to reemphasize , maybe insulin will be the only medication any diabetic every takes again. That is what the WOW, WOW, WOW was all about."
April 10, 2015:
Sanofi trained one set of reps to detail 'Afrezza and another set of reps to detail Toujeo. I have been detailed by the Afrezza rep three times and earlier this week I was detailed by the Toujeo rep. Quite common in the industry to do it this way, so I do not understand this first and second call post
June 4, 2015:
My Sanofi rep gave my assistant a number to call when a patient needs a prior authorization for Afrezza coverage. He explained that would keep us from doing the leg work. I have no idea who these people are or what she tells them, but yesterday I heard her call a patient to explain that there would be a delay as the service was experiencing excessive call volume
Yes , we do it l of the time. HIPAA allows exchange of information that is done to take care of the needs of the patient. We give information to home health agencies, hospices, laboratories, and to physicians we refer to on a daily basis. As a matter of fact, it is one of the few benefits of an EHR as this information is prepopulated and can be emailed or electronically faxed. Your skepticism seems excessive
June 15, 2015:
DTC ads starts July 8th.
Disclosure: I am/we are long MNKD.