Vdex

[sportsrancho]

May 18, 2022 9:34:49 GMT -5 od said:

May 17, 2022 22:31:27 GMT -5 sportsrancho said:

A Recent, True Story

Recently, I went to a doctor’s appointment for a personal issue. The physician and I got to talking about my work and I mentioned Vdex and Afrezza, whereupon he disclosed that he takes Afrezza for his Type 2 diabetes. He also takes metformin, Ozempic, Tresiba, Farxiga and one other medicine I can’t recall at this writing. His HbA1c is in the 7s.

I explained that I understood in that appointment setting he was the doctor and I the patient. Then I told him “Respectfully, you’re using Afrezza wrong.” To his credit he was willing to listen to my explanation. Turns out he used Afrezza occasionally for corrections, basically as the last therapeutic agent to control his BG. His physician is a very well-known diabetes specialist in Los Angeles. I explained how he could get far better control, likely in the 5s with no hypos and likely no basal insulin at all. He could also eliminate, or at least reduce, the other medications he was using. He was intrigued.

He asked more questions and by the time I finished, he asked if he could mention my name to his LA physician. I agreed. He clearly appreciated the 180-degree philosophical shift from how his physician was treating his diabetes to what I was advocating. More importantly, he understood “why” the treatment approach I was recommending made more sense than how he was being treated.

Now, while I know he’ll speak to his doctor about it, I’m also virtually certain that doctor will disagree with me and perhaps attempt to discredit me. He will have an impressive-sounding explanation for why Afrezza should be used the way he is rather than the way Vdex advocates. In short, my doctor will not likely change the management of his disease to the Vdex approach.

Why do I relate this story? Simple, the better informed the person, the more difficult to change them. This is counterintuitive on first glance, but I can explain. The better-informed person, let’s say “smarter” as a shorthand, is less likely to believe the highly improbably story that his/her care is exactly the opposite of what it should be. The smarter person “knows” that the consensus cannot be so wrong. The smarter person draws confidence from other smart people.

This is a version of the Emperor’s new clothes effect. It took the naïve child to say, “but the emperor isn’t wearing any clothes.” Out of the mouth of babes…

Ergo, it is highly unlikely that reps can change a physician’s mind in how they should use Afrezza. It’s why at Vdex we eschew talking to the docs. We don’t waste our time. Our goal is simply to get as many people using Afrezza successfully, one “poor, dumb” patient at a time. When we get enough, the docs will follow.

Doctors don’t lead; they follow. Another truism.

I will report back on this as I will be seeing my doc again in a couple months. Anybody wanna bet what I hear?

~ Bill McCullough, CEO Vdex Diabetes

Great (sad) post, Sports. However, I think it is unfair to demonize providers. Remember years ago when most agreed the Afrezza launch was a disaster (not the $$$ but how MannKind executed)? No seeding the community with publications or data, limited opinion leader support, probably minimal market research. MannKind and shareholders, were so enamored with Afrezza, the assumption was why would it not be an instant blockbuster. Experienced Pharma would have spent years pre-launch creating the glide path for market acceptance (I am not talking about bullying ADA). Is it possible that provider’s resistance is as much MannKind’s responsibility as it is treatment/prescribing inertia?

From Bill:
“I mostly agree with the point about not demonizing providers. MNKD hasn’t given them the data to change their habits. One overall point of my story is that MNKD really won’t make much headway with providers until it gets the data to show them. Sorry to say.”

[od]

May 18, 2022 13:55:49 GMT -5 sportsrancho said:

May 18, 2022 9:34:49 GMT -5 od said:

Great (sad) post, Sports. However, I think it is unfair to demonize providers. Remember years ago when most agreed the Afrezza launch was a disaster (not the $$$ but how MannKind executed)? No seeding the community with publications or data, limited opinion leader support, probably minimal market research. MannKind and shareholders, were so enamored with Afrezza, the assumption was why would it not be an instant blockbuster. Experienced Pharma would have spent years pre-launch creating the glide path for market acceptance (I am not talking about bullying ADA). Is it possible that provider’s resistance is as much MannKind’s responsibility as it is treatment/prescribing inertia?

From Bill:
“I mostly agree with the point about not demonizing providers. MNKD hasn’t given them the data to change their habits. One overall point of my story is that MNKD really won’t make much headway with providers until it gets the data to show them. Sorry to say.”

Spot-on, Bill! 

[prcgorman2]

Great thread. Thanks for posting Bill’s comments Sports!

[sayhey24]

There are some really good thoughts on this thread. One comment I have heard through the years is we never did the large study showing afrezza was superior to antiglycemics. "Since we don't have the data we can't get it to the providers."

So I went back to 8/14/2013. I know exactly where I was which was Avon NC. I thought maybe I was forgetting what I heard back then so I pulled some old info and it sure seems the 175 study had some pretty good results. The 175 Affinity2 was not a small study. It was over 300 people. We also know back in the day they had no CGMs for this study and they were not properly dosing.

Highlights of Study 175
In patients with type 2 diabetes treated with oral therapy, AFREZZA, compared to oral therapy alone, showed:
● Superior reductions in A1c levels;
● Significantly more patients reached A1c target levels;
● Reduced postprandial glucose excursions; and
● No significant difference in the incidence of severe hypoglycemia.

investors.mannkindcorp.com/static-files/c2354b55-8886-4140-9147-50dfb33db7dd

When Dave Kendall showed up he also said we had a lot of good data. He also had access to many studies in addition to the Affinty2 trial. Dave said the issue was not having the data but that we never leveraged the data to get afrezza its proper place in the ADA T2 SoC.

I will also say the T1 market and the T2 market are significantly different. How you market and sell to them is night and day. I think they are so different that there should be two separate products; one for the T1s; one for the T2s. The active ingredient would be the same - insulin but the name, packaging, dosing and label would be different.

Focusing on the T2 market - Section 9 of the ADA SoC for T2 in not so many words says start with metformin and then add a GLP1 or SGLT2. 2022 sales of GLP1s should be around $15B and SGLT2s should be around $9B. If I do the arithmetic thats $24B which is a pretty big number.

Section 9.4b says the following - Other medications (glucagonlike peptide 1 receptor agonists,sodium–glucose cotransporter2 inhibitors), with or without metformin based on glycemic needs, are appropriate initial therapy for individuals with type 2 diabetes with or at high risk for therosclerotic cardiovascular disease, heart failure, and/or chronic kidney disease
diabetesjournals.org/care/issue/45/Supplement_1

In addition there are a lot of words about insulin which could be leveraged but they are clearly not talking about afrezza. They are talking about insulin as everyone thinks of insulin. Its subq, requires a needle, its short/med/fast acting. Its dangerous. Its not afrezza. While the active ingredient in afrezza is insulin everything about afrezza sets it apart as a unique treatment and can not be lumped into the "insulin" category. It is a new class of treatment and needs to be understood and known as a new type of treatment.

Bill said - "Ergo, it is highly unlikely that reps can change a physician’s mind in how they should use Afrezza." I fully agree with this. However, if the Standard of Care says do this or that, these same physicians may have a different attitude. As the new doctors come out of school they will have been taught the ADA SoC. I have to agree with Dave Kendall that getting the proper inclusion of afrezza in the SoC is the road to afrezza sales. IMO, until that is done, sending out reps knocking on doors will do very little. Its just a waste of money.

I am even thinking Mike may want to submit a new drug application for a version of afrezza which is targeted at the T2 market. This would include a name change. I would include GLP1-R in the name - "afrezza GLP1-R" where R is for replacement of GLP1 use. There would be a specific trial against Mounjaro as this is the latest and greatest GIP/GLP1 on the market. The cartridges would no longer be called units. This is OK with proper dosing in the T1 world but not T2. The cartridges for the T2s would be small, medium and large. The packaging and label would reduce the use of the word insulin. While the active ingredient in "afrezza GLP1-R" is insulin, afrezza is much more than insulin. It can do what "insulin" can not and as we have already seen from Affinty2, the danger factor of severe hypoglycemia is not a characteristic of "afrezza GPL1-R".

I would put the word insulin in the context of "active ingredient" on the packaging and label. Other places it needs to be would be in microfont.

With CGMs and software like Clarity a pilot study can be done in weeks and a full large study can be in the can by this time next year. Between this study and the India study which sounds like a better dosed Affinty2 maybe some of Bill's doctors will listen a little more and Mike can get a new class of drug added to the SoC with the hope it would be a step before GIP/GLP1 use.