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Post by peppy on Sept 21, 2016 11:33:33 GMT -5
The physician sited had heard the name. The physician compared afrezza to exubera and had to google the exubera name. Exubera a hexamer. Afrezza a monmer. Exubera no phase one. Afrezza phase one stops the liver from putting out glucose. Very different. This physician was not aware of the difference.
Regarding will more PWD fight for Afrezza? Consider, the objective, to keep us dumbed down and dying.
Pep
You missed the point of his email. It wasn't to compare the qualities of Exubera to Afrezza. It was that both were inhaled insulins and how that affects lung function. Has nothing to do with metabolism. Alrighty then, I'll try again to understand the email.
My new understanding, this PCP gave you LIP SERVICE>
13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility In a 104 week carcinogenicity study, rats were given doses up to 46 mg/kg/day of the carrier and up to 1.23 mg/kg/day of insulin, by nose-only inhalation. No increased incidence of tumors was observed at systemic exposures equivalent to the insulin at a maximum daily AFREZZA dose of 99 mg based on a comparison of relative body surface areas across species. In a 26 week carcinogenicity study, transgenic mice (Tg-ras-H2) given doses up to 75 mg/kg/day of carrier and up to 5 mg/kg/day of AFREZZA. No increased incidence of tumors was observed. AFREZZA was not genotoxic in Ames bacterial mutagenicity assay and in the chromosome aberration assay, using human peripheral lymphocytes with or without metabolic activation. The carrier alone was not genotoxic in the in vivo mouse micronucleus assay. In female rats given subcutaneous doses of 10, 30, and 100 mg/kg/day of carrier (vehicle without insulin) beginning 2 weeks prior to mating until gestation day 7, there were no adverse effects on male fertility at doses up to 100 mg/kg/day (a systemic exposure 14-21 times that following the maximum daily AFREZZA dose of 99 mg based on AUC). In female rats there was increased pre- and post-implantation loss at 100 mg/kg/day but not at 30 mg/kg/day (14-21 times higher systemic exposure than the maximum daily AFREZZA dose of 99 mg based on AUC). afrezza.com/wp-content/uploads/2016/08/afrezza.pdf
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Post by madog365 on Sept 21, 2016 11:39:25 GMT -5
All the doctor's concerns and questions can be answered with this one article (http://www.ajmc.com/journals/evidence-based-diabetes-management/2016/september-2016/Afrezza-Treating-Diabetes-in-a-Physiologic-Manner). It should be distributed at every diabetes related conference at the Mannkind booth.
As far as the slow uptake in scripts, i'll say it again. No one outside of this investor community, a few small diabetes message boards, and a handful of early adopters has heard of Afrezza. Yes, i am including the majority doctors as well. Those that have heard the name associate it with old information about Exhubera, because that drug actually did have some marketing behind it many years ago. There has been no DTC marketing done to date by Mannkind and the Sanofi placements were laughable. Boots on the ground sales without the support of marketing is a useless endeavor. Afrezza has real benefits, a unique value prop from other meal time insulins, and yet no one has heard of it. I mean think about this, an investor had to ASK an EXCLUSIVELY diabetes focused website to add Afrezza to its Rapid Acting Insulin category. Even for them, Afrezza was an afterthought. Every presentation we are told that there are millions of patients not at goal, yet i guarantee they have no idea another option Afrezza even exists and the company has done nothing yet to reach out to them.
I continue to wait for Mike to show us the first signs of his marketing plan.
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Post by slugworth008 on Sept 21, 2016 11:53:25 GMT -5
I'm not saying I agree with what he's saying, but I decided to post an email I recently received from a PCP that I know. I have heard about Afrezza. Let’s see what happens with this drug. There have been prior inhaled insulin’s, Exubera, that did not make it. I couldn’t remember the name but I looked it up. Several years ago we did some studies with it to see if it affected lung function. I am not sure of the results. It was pulled from the market. Patient’s with underlying lung disease were excluded from using it. If I were diabetic, I would not use it until it was thoroughly tested and trialed for years. I would like to see if there are any long term pulmonary effects. It’s one thing to inhale meds to help lung function, but I am not a fan of inhaling anything else. The large and small airways as well as the alveolar membranes are susceptible to irritants. The mucociliary cascade can only protect so much. Irregular absorption could be a problem.
I've seen this discussed a bunch already in the time I've been here. More time is needed to convince doctors that Afrezza is safe and superior. (I think) the reason Afrezza has had a slow uptake is because medicine is conservative. I know this isn't new. I've seen it discussed on here. Based on my discussions with the above PCP and others that I know, they don't perceive that the risks outweigh the benefits. PWD can live 5-6 decades with the disease. Not saying that there won't be limb loss or sight/hearing losses involved as well as a myriad of other secondary diseases, but they don't feel any urgency to shake things up considering the "success" of the current system. To them, causing lung diseases would cause a much more rapid decline than the complications associated with diabetes. Why create a more severe problem to solve a lesser one is their rationale.
I truly believe that time is all that is needed for Afrezza to prove itself. I know that there were only about 2-4 issues with lung cancer out of all the people who were involved in Afrezza trials. For those who like links, here ya go. That article was written by a physician. Good or bad, right or wrong, the reality is that there appears to be risk involved with Afrezza. And those risks appear to docs to be more significant than the benefits. I can't say for sure that all doctors think this way- obviously some do prescribe. To say that doctors haven't heard of Afrezza is not an accurate statement, though. The ratio of docs who have heard of Afrezza to those who prescribe it is just very, very low. If there was interest in prescribing, it would be evident by now. The majority of docs who know about Afrezza have chosen not to. We might be able to find a few more who will if we look for them, but the assumption based on the current trend is that it's more similar to finding a needle in a haystack. This won't turn into a blockbuster overnight. It will take a long time to prove itself, then there may be an inflection point. Who knows how long that amount of time will be...the pcp is uneducated.It was tested 4 many years now.there were studies done for irregular absorption too..unfortunately, its the docs that have to rx. This is where marketing helps. Exactly on the marketing comment. I truly believe marketing to end users is what it is going to take to drive demand. We'll see what happens over the coming months.
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Post by cjm18 on Sept 21, 2016 11:54:07 GMT -5
I talked about Afrezza with my sister *after* I bought into it. She warned me that the uptake would be slow until it was adopted by pediatrics and to stay away from the stock until then. I should have sold back then but I figured it was just a matter of time. She believe it could be a block buster and accepted by PCP after it was accepted by pediatricians but until then doctors would be reluctant to prescribe. By way of credentials she was on the President's council, a hospital director, an RN, a regular author to the NEJM, editor of the physcians desk reference and has enough other credentials to fill this page.
We don't know the situation with RLS but if there's a milestone payment coming, my hope is that we can survive and complete the pediatrics testing. In the meantime, the only way scripts are going to increase is if patient's ask for it. I've been following Mannkind's & Mike's Twitter but a few posts here and there don't make the social media campaign Matt promised. I was really expecting that Matt would follow up on the Israeli opportunity and at least have some international such as Teva and Shire lined up for some R&D pipeline.
This totally makes sense. If afrezza is safe for kids then it's safe for adults. Kids are more afraid of needles. Kids don't smoke. Skipping novolog/humalog and going straight to afrezza is possible for newly diagnosed type ones. Good news is jdrf is onboard but who knows how long until afrezza is approved for kids.
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Post by figglebird on Sept 21, 2016 11:58:51 GMT -5
There is ample information that suggests it will be safe for kids - All one need do is look over the EXHUBRA phase 1 juvenile studies that showed the same correlation as to adults - further afrezza time and again improved upon those metrics p1 2 and 3 on adults.
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Post by cjm18 on Sept 21, 2016 12:29:19 GMT -5
There is ample information that suggests it will be safe for kids - All one need do is look over the EXHUBRA phase 1 juvenile studies that showed the same correlation as to adults - further afrezza time and again improved upon those metrics p1 2 and 3 on adults. I don't disagree. If only every doctor has the time or what not to know this. Parents are doctor hunting for one that will prescribe off label.
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Post by sportsrancho on Sept 21, 2016 12:49:42 GMT -5
There is ample information that suggests it will be safe for kids - All one need do is look over the EXHUBRA phase 1 juvenile studies that showed the same correlation as to adults - further afrezza time and again improved upon those metrics p1 2 and 3 on adults. I don't disagree. If only every doctor has the time or what not to know this. Parents are doctor hunting for one that will prescribe off label. If you are a Ped Endo who prescribes Afrezza you are hot right now! Parents are demanding Afrezza! Most doctors Do Not know about Afrezza! The demand will have to come from the patient!
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Post by matt on Sept 21, 2016 13:08:13 GMT -5
Peppy, the data you quoted is just what is says it is: non-clinical toxicology. While these are acceptable tests for FDA approval, both 104 week and especially 26 week studies on carcinogenicity are extremely short periods. A lot of smokers die of lung cancer, but only after long periods of usage. Most smokers start in their teens, but there are very few smoking related cancer deaths in the under 20 population. If a physician does not prescribe Afrezza out of an abundance of caution, you cannot quarrel with that because it is a reasonable professional judgment. However, if the patient decamps to a different physician, you cannot quarrel with that either.
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Post by peppy on Sept 21, 2016 14:04:37 GMT -5
Peppy, the data you quoted is just what is says it is: non-clinical toxicology. While these are acceptable tests for FDA approval, both 104 week and especially 26 week studies on carcinogenicity are extremely short periods. A lot of smokers die of lung cancer, but only after long periods of usage. Most smokers start in their teens, but there are very few smoking related cancer deaths in the under 20 population. If a physician does not prescribe Afrezza out of an abundance of caution, you cannot quarrel with that because it is a reasonable professional judgment. However, if the patient decamps to a different physician, you cannot quarrel with that either. Overall type 1 life expectancy 12.2 years less than general population www.diabetesincontrol.com/life-expectancy-for-type-1-diabetes/
Cigarette smoking causes premature death: Life expectancy for smokers is at least 10 years shorter than for nonsmokers. Quitting smoking before the age of 40 reduces the risk of dying from smoking-related disease by about 90%.Aug 18, 2015 www.cdc.gov/tobacco/data_statistics/fact_sheets/health_effects/tobacco_related_mortality/
a lot of meat, fish and eggs, = heart attack .
A physician can not be sued when a diabetic has a heart attack.
what to do, what to do. screencast.com/t/O4E1NxGdWKvt
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Post by dreamboatcruise on Sept 21, 2016 14:58:35 GMT -5
Not good. Were they on prandial insulin? I'll be interested in the answer to this question. I can see if it's a type 2 currently on metaformin and ok with their numbers. But when the time comes for insulin and they have the choice between the pen or Afrezza and they are going the pen well that spells trouble. Or the time when they are on insulin and their A1c is in the range where a doctor is warning them of the dire consequences.
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Post by liane on Sept 21, 2016 15:20:53 GMT -5
dbc, I'll be totally off-topic. I would have sent this PM, but couldn't figure out how to add the attachment in a PM. Anyway - my niece (the vet)'s newest addition to the household:
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Post by peppy on Sept 21, 2016 15:31:08 GMT -5
dbc, I'll be totally off-topic. I would have sent this PM, but couldn't figure out how to add the attachment in a PM. Anyway - my niece (the vet)'s newest addition to the household: Liane, are you OK? you seemed to have changed life forms.
(Last post for the day, I promise.)
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Post by Deleted on Sept 21, 2016 15:32:29 GMT -5
From my limited experience with diabetics, the few I am aware of that I reached out to didn't show any interest in the drug. Neither the delivery method nor the results. I was surprised by the lazy nonchalant reaction. As time goes by things are starting to make more sense. I got my college roommate on it. He looked into for 9 months had no idea what a CGM was, and that the technology had improved so much. Which is interesting because he works in computers where technology is always evolving. My wife's co worker type two eats KFC every day, is obese and takes nothing. My sister in law is type 1 drinks and smokes cigarettes and has poor control. My cousin is type 1 and had his foot amputated I under estimated that people do not take care of themselves. Which hindsight really shouldn't be a shock. Most people are severely over weight. Most people hate going to the Dr.
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Post by liane on Sept 21, 2016 15:36:06 GMT -5
dbc, I'll be totally off-topic. I would have sent this PM, but couldn't figure out how to add the attachment in a PM. Anyway - my niece (the vet)'s newest addition to the household: Liane, are you OK? you seemed to have changed life forms.
(Last post for the day, I promise.)
He's a killer in disguise.
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Post by mnholdem on Sept 21, 2016 15:40:05 GMT -5
If I had to guess, I'd say the avatar is peregrine falcon chick. What's the subliminal message here, liane?
"One day I'll be really, really fast...just not today"?
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