# What's everyone's take on Afrezza?



## DeusXM (Mar 2, 2015)

There's a lot of buzz right now about Afrezza - for those who are uninitiated, it's an insulin inhaler device that delivers super-rapid-acting insulin which supposedly promises to almost eliminate hypos. There are also users out there who are claiming they don't even need to carb-count anymore.

I've raised a few questions on this. One thing I strongly object to is the fact that over $1bn has been sunk into this, more than any diabetes medication I can think of. I understand that pharmaceutical companies need to make a profit but to me, there seems to be something very obscene about spending so much money on what is possibly a slightly better insulin, and presumably diverting cash and expertise away from developing a cure.

I've raised this objection publically elsewhere, and the response has been, um, interesting.

One of the best resources for information out there is http://afrezzauser.com/. Great information, sounds like a real success story. But then you read between the lines. Much of the problems that the author states they had before Afrezza seem symptomatic of just plain bad diabetes management - complaints about taking too much insulin causing hypos etc. I'm not disputing the challenges we all face here but this particular case just sounds a bit too much like someone not really trying.

Then there's the bit that really bothers me, particularly as I work in PR and marketing and I know how this game is played.

What sort of a person sets up a blog devoted to one particular medication?

There's quite a few Tweeters and bloggers who all seem to have magically appeared all of a sudden, very recently, who then either blog or tweet about nothing BUT Afrezza and some of the more extreme of them start declaring Alfred Mann (the guy behind Mannkind, the developer of Afrezza) as some sort of latter-day saint. Again, I don't dispute that Alfred Mann has played a pivotal role in many life-changing technologies (pumps and prosthetics among them) but the moment you start pointing out these were excellent business decisions that create a certain level of market dependency, I've noticed that Afrezza trialers act as if you've just shot their favourite puppy in front of them and then tried to feed it to their mother as a casserole. Even more interestingly, if you do this on a forum, almost without fail, a new user will magically appear to tell you that you are wrong and then never post again. This has actually happened on this board, to Northerner, I note.

Meanwhile I've also been speaking to reliable bloggers out there who say I'm just failing to appreciate Afrezza for what it is because the feedback has been so good, no-one has anything negative to say about it.

Do we believe this?

Is it really possible that there is a medication out there that has zero side effects, is completely flawless and even seems to let you bolus without any need for carbohydrate whatsoever?

I don't think so. 

I'd like to try Afrezza, certainly. But just as a head-up for everyone...if when you start suggesting a particular medication isn't a complete miracle and its funder isn't Jesus incarnate, and the response is open hostility, disbelief, accusations of trying to short stock and all of this comes from people whose entire online footprint consists purely of talk about Afrezza....do you think we're being played? And do we want to open up a book on whether or not a one-off poster might suddenly appear in this thread?


----------



## Northerner (Mar 2, 2015)

Well, I'm certainly not a one-off poster  But I do agree that all avenues for hype are being explored - I'm sure it's true of many products these days. I would also be suspicious of anyone who set up purely in support and promotion of a single product (as I do about anyone who says there is only one thing/diet/magic fruit/sea nymph who can solve a problem whether physical, metaphysical or purely fantastical. OK, maybe bacon comes close 

I've never liked the concept of inhaling insulin - maybe if that's what Banting and Best had come up with then I would be happier with it, but if that were the case, I wouldn't be surprised if, by now, someone had come up with the groundbreaking notion of injecting it or feeding it through a canula from a pump. I haven't researched too deeply into it, but you would think that some of the more basic questions and their answers would have bubbled to the surface. Such as what really is the long-term effect of inhaling it? How do you fine tune a dose if you are particularly sensitive to it? How do you take in sufficient if, on the contrary, you are insulin-resistant, and need lots and lots? The quantities per squirt are fixed, are they not? How does it relate, cost-wise, to injected insulin? Loads of other questions I'm sure.

They really can't afford for it to fail, and I be whatever is percolating through here in support of it is minuscule compared to the massive marketing effort being applied to the US physicians and health insurers.

It's not for me, I prefer a concept like smart insulin or, even better, an actual cure. As you say, $1bn would have gone a looooong way to increasing the odds of the cure being found, given how many potentials are currently only 10 years away, and no doubt hampered in their progress to some extent by lack of funding to speed things up.


----------



## Annette (Mar 2, 2015)

DeusXM said:


> Is it really possible that there is a medication out there that has zero side effects, is completely flawless and even seems to let you bolus without any need for carbohydrate whatsoever?



Well if there is, it isn't this one 
Just read this post about the review in The Medical Letter:
"Afrezza, the only inhaled formulation of insulin currently available in the US, appears to be only modestly effective in reducing HBA1c. Cough is a common side effect and the long-term pulmonary safety of inhaling insulin is unknown." 

Review here: http://www.thestreet.com/story/1306...ter-review-from-independent-drug-arbiter.html


----------



## DeusXM (Mar 2, 2015)

> Well, I'm certainly not a one-off poster



Absolutely - but when you posted your understandable concerns before, a one-off poster arrived mysteriously to tell you that you were wrong!

http://diabetessupport.co.uk/boards/showthread.php?t=51226


----------



## Northerner (Mar 2, 2015)

DeusXM said:


> Absolutely - but when you posted your understandable concerns before, a one-off poster arrived mysteriously to tell you that you were wrong!
> 
> http://diabetessupport.co.uk/boards/showthread.php?t=51226



And doesn't actually appear to be diabetic, given his registration details


----------



## Robin (Mar 2, 2015)

What would happen if you had a streaming cold? or hay fever? There are times when there's so much coming downwards, I wouldn't stand a chance of getting anything UP my nose! (Sorry if the description is a bit graphic, hope nobody was in the middle of their tea)


----------



## Northerner (Mar 2, 2015)

Robin said:


> What would happen if you had a streaming cold? or hay fever? There are times when there's so much coming downwards, I wouldn't stand a chance of getting anything UP my nose! (Sorry if the description is a bit graphic, hope nobody was in the middle of their tea)



What about this other 'cheeky' alternative to injections (something else that doesn't quite seem to have caught on...)

http://diabetespoetry.blogspot.co.uk/2010/08/its-behind-you-alternative-to.html


----------



## Robin (Mar 2, 2015)

Glad I wasn't eating MY tea when I read that!


----------



## KookyCat (Mar 2, 2015)

Hype aside, and snorting insulin too (yuk), I think super rapid insulin is the key, if you have an insulin capable of acting almost instantly you have the means for perfect control.  It's the only way a closed loop system would ever actually work like a pancreas really.  In fact I've been wondering if I could go completely rogue on novorapid myself, given my rapid reaction to it, but I suspect I'd need more than an excel spreadsheet to work that out


----------



## Redkite (Mar 2, 2015)

I'm a born cynic, and my view is that somebody is banking on Afrezza to take over from injected insulin and earn him $1,000,000,000's!  Given a choice of two equally effective (I'm not saying they are) insulin delivery methods, doctors are far more likely to prescribe something that doesn't require the patient to wave needles about.  And also, people are fearful of needles (before my son was diagnosed this would have seemed like the biggest deal to me), so maybe it would be a more popular choice.  And perhaps cheaper for Health Services and medical insurers? 

But personally I have huge concerns about taking in a substance via the lung tissue, and the possible ill effects of long term use, and no way would I agree to my son trialling it.


----------



## Redkite (Mar 2, 2015)

KookyCat said:


> Hype aside, and snorting insulin too (yuk), I think super rapid insulin is the key, if you have an insulin capable of acting almost instantly you have the means for perfect control.



The insulin pump can apparently be implanted in your abdominal cavity for a much more rapid delivery of insulin.  I believe Lesley from INPUT has an implanted pump.


----------



## HOBIE (Mar 2, 2015)

Sounds a bit "Cold" to me "A Freezer"  Hope its true but   Would put my money on the "NUK" team


----------



## KookyCat (Mar 2, 2015)

Redkite said:


> The insulin pump can apparently be implanted in your abdominal cavity for a much more rapid delivery of insulin.  I believe Lesley from INPUT has an implanted pump.



I've read about that but apparently it's still not quite as rapid.  Interesting stuff though, and there's something about liver function that I'm still absorbing .  Definitely not on board with inhaling a drug a though, there's no way I'd risk that.


----------



## trophywench (Mar 2, 2015)

NO no no !  - Lesley has a Diaport - she had trouble with sites, I dunno why - and a Diaport is basically, a stoma - I dunno if it acts like a cannula so you can attach a pump, or inject into it, or some other means of delivery.

However she's on either her second or third now.  Apparently because it's always all going into the same place, whatever insulin she uses, crystalizes round the internal bit under her skin, so they've had to give her a GA , take it out, scrape away the crystals, and re - implant it.  (you have to have it done under GA anyway)

I was going to contact her to ask about it, thinking it may be a solution for me, until I read what she'd already written about it.

There have been other inhaleable insulins in the past - which have never ever been popular.

I agree with Redkite - for weeks and weeks I've had severe difficulty actually breathing through my nose - I'd have been dead by now if I had to inhale my insulin.  And this is by no means a new phenomenon for me - I've had the same sort of colds all my life, I once jokingly said (but based on the truth) that I actually only have one cold a year.  From October to March, usually !


----------



## everydayupsanddowns (Mar 3, 2015)

I'm pretty sure the dia port goes into the inner cavity (intra-peritoneum?) - the tube is much longer and goes way below subcutaneous. Lesley showed me once and she just connects infusion set tubing to it like 'normal' but doesn't need to change the site


----------



## trophywench (Mar 3, 2015)

Yeah, but it was the apparent 'normality' of this thing with the crystallization happening that I didn't fancy, Mike.  Esp since I throw up for a week after a GA anyway, and have to stay on a drip having vile injections into my thigh muscles for the duration cos I can't eat or drink ! (The alternative to the jabs is rectal suppositories which actually are a lot less unpleasant TBH, but to know you've actually chosen to have the procedure rather than only having the operation cos you had little alternative?  I don't think so, do you? !!)

Just shows there's snags whatever way we do it, with what's currently available, doesn't it?


----------



## Redkite (Mar 3, 2015)

Yes I wouldn't fancy Lesley's set up either!


----------



## ScottAMP (Mar 13, 2015)

*The infamous 1st time poster, posting again!!*

I guess that I am the one time poster that DeusXM is talking about. (Well technically not true anymore as this is my second☺ )

Also, prior to this reply, I reread my previous post and I don’t think that it could in anyway be interpreted that I was claiming Northerner was wrong. I was merely pointing out that the level of claimed control from Afrezzauser was impressive and worth a look.

I am not diabetic and never claimed to be, However I have watched my Sister in Law as Type 1 over many years deal with complications that no doubt originated from less than perfect discipline; probably due to denial during the early stages and a lack of understanding about her condition.  It has taken her a considerable time to get a handle on the disease and unfortunately took a hospital stay before she really got on top of things. 

Regardless of the reason, she has struggled to manage her condition effectively and still has issues bouncing between the high and lows whilst constantly readjusting to manage food intake and the long tail effect of her current fast acting insulin.

My interest in Afrezza originated after watching an Al Mann interview regarding the drug and how he had not seen any other insulin behave in the same way as afrezza did.

He was an extremely impressive individual,  a self made Billionaire, and at almost 90 had personally funded the development and approval through numerous challenges to a cost of $1billion.  And whilst I accept that $1 Billion could have helped fund research towards a permanent cure, I do not believe that anyone can argue how an individual wants to spend his own money.

I continued my research in Afrezza and in the interests of disclosure, after this point I did make a long-term investment in this business.

Since its launch I have continued to keep my eye out for Internet articles and blogs; looking for user feedback and opinion and whilst I fully accept it is entirely possible that bloggers, particularly those that only blog about one product, including afrezzauser, could be receiving compensation directly or indirectly from the drug companies. 

I do not accept that Sam FInta ( Afrezzauser ) who has been specifically identified and was part of the original FDA trials would then put himself  at  a considerable litigation risk by fraudulently representing fake performance data through the written word and his supporting images.

It is possible that he may be painting a rosier picture to the external world, but if only a proportion of what he is currently claiming proves to be true across a larger representative sample of the diabetic population (E.g. Tight Blood Glucose level control, reversal of insulin resistance and the lack of Hypo readings when Afrezza was used without any carb intake) then I am personally very excited about its future benefits.

Whilst my Sister in Law is eager to trial Afrezza, I accept that this is probably due to our discussions and I understand that there can be general skepticism and a fear of the unknown regarding any new product particularly when it has a new delivery method.  But Afrezza appears to be creating a ‘buzz’ all of its own through social media, great reviews on sites like WebMD and mixed in with those people who perhaps have their own agenda, the underlying message appears to be more than supportive and this is something that I continue to monitor.

I therefore reiterate my initial comments that I believe that Afrezza’s progress and particularly the user feedback is certainly worth monitoring closely by the Diabetic community and that it should not be written off just simply because it is different. 

UK diabetics should hopefully have a slightly easier path than the US as they will have the benefit of a little more time to hear and digest additional user experience information before the product is available here.


----------



## DeusXM (Mar 13, 2015)

> My interest in Afrezza originated after watching an Al Mann interview regarding the drug and how he had not seen any other insulin behave in the same way as afrezza did.
> 
> He was an extremely impressive individual, a self made Billionaire, and at almost 90 had personally funded the development and approval through numerous challenges to a cost of $1billion.



And here we go....yet another Afrezza cheerleader who seems incapable of posting without sounding a bit like a pod person. No-one ever seems to know who is the guy in charge at Novo Nordisk or Bayer or Sanofi or any of the other  companies that have successfully created effective, profitable medication for diabetes, do they? Why is it that Al Mann is always singled out? I'm not disputing he's made useful contributions to a variety of fields of medicine, but he's no Banting or Best - he's a guy that knows how to invest his money in clever people who then never get credited for the work they do. That doesn't make him a hero, that makes him a good investor.



> whilst I accept that $1 Billion could have helped fund research towards a permanent cure, I do not believe that anyone can argue how an individual wants to spend his own money.



Of course. But I believe we should be actively critical and skeptical of those who invest $1bn in a revenue stream rather than a cure and then expect us to be grateful and elevate them to the position of 'hero'. 



> I do not accept that Sam FInta ( Afrezzauser ) who has been specifically identified and was part of the original FDA trials would then put himself at a considerable litigation risk by fraudulently representing fake performance data through the written word and his supporting images.



And I don't think I ever stated that I thought Sam Finta was lying. I believe his testimony. The problem I have with it is even just a quick scan through and I can see several instances where the problems he associates with injected insulin aren't really problems with the insulin, but with his own approach to diabetes management. I don't agree with this picture that we're apparently all just a few minutes away from collapsing with hypos because of our terrible insulin which we've no idea how to use. I can only speak for myself but having treated my diabetes with insulin injections for 16 years, I can tell you exactly how many times I've been in serious danger because of terrible insulin - it's 0 times. So while I don't dispute Sam's experience, I don't think it's right to portray multiple serious hypos that need other people's assistance as being standard or even common for people on insulin.



> I understand that there can be general skepticism and a fear of the unknown regarding any new product particularly when it has a new delivery method.



Not at all. I'm all in favour of new insulins and potentially more effective delivery methods. 

It's just that if I was genuinely serious about tackling the horror of diabetes (as Al Mann is, supposedly), I'd have invested $1bn in something a bit more permanent, rather than something that's essentially a new product line. There are several promising routes to cures for diabetes that have yet to go into human trials because they can't get funding. You probably do not understand how frustrating it is to live with this condition, see promising cures on the horizon and then find the money is being spent on anything other than these cures.



> But Afrezza appears to be creating a ‘buzz’ all of its own through social media, great reviews on sites like WebMD and mixed in with those people who perhaps have their own agenda, the underlying message appears to be more than supportive and this is something that I continue to monitor.



Dear lord....so we're now taking having 'buzz' on social media as some kind of proof of wonderfulness. There's 'buzz' on social media for videos of cats falling over. There's also a lot of astro-turfing - my own personal experience is the moment you post something on Twitter that doesn't suggest Al Mann is our saviour and that Afrezza is awesome, you get flamed straight away by people who quickly turn out to be investors. That's not buzz. That's not positive. That's people wanting to protect their money and placing their concerns above my wanting to protect my health.

I'll be interested to see what happens as more people go on to Afrezza, whether the positive experience will be repeated, and importantly, whether that apparently important social media 'buzz' will allow dissenting voices.



> I therefore reiterate my initial comments that I believe that Afrezza’s progress and particularly the user feedback is certainly worth monitoring closely by the Diabetic community and that it should not be written off just simply because it is different.



Then you clearly don't understand my concerns. I'm not writing off Afrezza because it's 'different' - I'm disputing entirely that it's different. It's just another insulin that probably works a bit better than what we have at the moment, which cost a fortune to develop. 

And then we're expected to be grateful. No-one ever actually asks us people with diabetes what we want, do they? Because of course, what we want generally can't be turned into a nice little profitable line.


----------



## Redkite (Mar 13, 2015)

Well said DeusXM, I agree with every word.

It's ridiculous to paint a picture of this Al Mann as some kind of caring philanthropist - he's invested his money in something he expects to generate him even more money, hence the aggressive marketing and the tiresome saturation all over social media.  What people with type 1 actually want is a CURE, but obviously if that happened, Al Mann wouldn't get a fat profit would he?


----------



## DeusXM (Mar 14, 2015)

I'll be honest, I'm also really heartened to see that the sort of people motivated to invest in Afrezza also seem wonderfully capable of completely disregarding legitimate concerns from actual people with diabetes as "oh, you're just frightened because it's new and different, we know what's best for you better than you do."


----------



## Copepod (Mar 14, 2015)

Either the product will get support of those who prescribe medications to people with diabetes or it won't. Only in countries where direct advertising to people with medical conditions is permitted will there be much demand from people with diabetes themselves, and then only if precribers can be persuaded.


----------



## ScottAMP (Mar 16, 2015)

DeusXM

I am sorry if have offended you in some way as your response towards me has been prickly to say the least. I only hope that you will at least read my response and consider the contents, although I fear from your previous posts that it may simply just crystalise your belief that I am some sort of crazy Al Mann fanatic, hopefully not, so here goes….  

I thought that the whole purpose of a forum/message board was to increase knowledge, share information and encourage debate.

I do not believe that I have made any statement, which should have offended, and if I did, then I apologise unreservedly. Your initial post complained about the ‘interesting’ response when Afrezza trailers overreacting to negativity and yet in response to my suggestion that feedback from a current user was worth reading, you took me to task in various replies; initially I was a one off poster never to be seen again, then just an Al Mann cheerleader,  you did not like my use of the word ‘buzz’; even though this word was extracted directly from your original post ( 5th word ), and in your most recent comment you were apparently heartened that I disregarded your legitimate concerns, which at no pointdo I believe I have done.

From your original post, your primary concern appeared to centre around if you or the community at large were being played and that concern remained even after you had also spoken to reliable bloggers who suggested that you simply did not fully appreciate things.

My first venture onto this forum (which by the way was my first ever post on any forum ) followed an initial post by Northerner where he ( apologies if I have incorrect gender) effectively said that Afrezza was not for him, He had also referenced Afrezza in a few previous posts, so although concerns existed, there appeared to be an outreach for conversation about Afrezza; hence my comment that the experiences of Afrezzauser were worth reading.

In previous posts Northerner had also outlined concerns regarding a delivery method through the lungs, which I fully understand is a legitimate issue. As a parent of two, I can also understand Redkites concerns when considering the wellbeing of her son, although Afrezza has not been approved for use in minors at this stage. 

My sister-in-law, does not have the same issue with an inhalation delivery method, perhaps because she was smoker many years ago or perhaps because she is more of a risk taker; but people are individuals and my guess is that the reaction and perceived risks will be different across a cross section of the community, after all ( and I appreciate the difference, before you point it out ) Asthma inhalers have been readily accepted by their users.

Neither does she have the same level of BG control as you appear to have, I accept your comments that not every diabetic is on the brink of Hypo’s, she still hates the lows even when she may not classify them as a Hypo and I accept the fact that you have exceptional control when compared to my sister-in-law. However, you must concede that across the entire diabetic community there are a significant number who do have the same level of control as you, some do not have the same level of perfect discipline and perhaps they eat what they should not, when they should not and you must also concede that high and low blood sugars create health risks.

I fully appreciate that Afrezza will not be for everyone, that concerns will exist and there will be the fear of the unknown, these may stem from the risk factors considered by the individual and the fact that we do not have data as to the long term effects beyond the clinical trials, that said, this does not prevent individuals from wanting to or being able to research developments.

You also seemed to take issue with regards to my disclosure as an investor and Northerner appeared to take exception to the fact that I am not diabetic, although I have a keen interest in treatments for the benefit of my Sister-in-law. 

Perhaps you believe that I have an ulterior motive, perhaps you believe that my post was specifically designed to encourage everyone to blindly get involved and invest in what at this stage a highly speculative, small America biotech company, in a bid to increase my own return.

Put aside that a UK investor would have to access the American markets and how ineffective this approach would likely be on a diabetic forum, to be perfectly honest I have better things to do with my time and as a Northerner myself, I was simply offering a steer to Northerner as to information available.

If we are both honest, at this point we have the same level of direct or indirect personal experience of Afrezza although I have taken time to research the product which I have found extremely interesting. 

For those members who would like to learn more, there are many reputable sites and a good starting point is  http://www.tudiabetes.org/forum/topics/i-started-on-afrezza-last-night this thread has received over 600 replies and there are interactions covering all sorts of questions and from here you can jump around to other useful resources around the web. There does appear to be some investors on the stream, although some of these are both investors and diabetics, but all in all the thread ihas some really useful information.

It covers user experience, the pharmacokinetics and how it performs in almost an identical way that naturally occurring insulin peaks and declines. How this means the insulin only stays whilst needed and has pretty much cleared from the bloodstream by the time the meal has been digested (typically three hours) instead of leaving a long tail effect beyond this point and the inevitable stacking issues. This this may be why the same level of discipline with Carb counting, exercise and titration is required.

I would be more than happy to regurgitate my own research in a summarized format, if that helped anyone, although following the above thread will give you links to tons of useful information. 

It is obviously still early stages with regards to real world use and whilst feedback is currently extremely positive, I am keeping a close eye on developments. 

Finally, I partially agree with copepod with regards to success ultimately coming from prescriber adoption, although I also believe that in the world in which we live today, its success or failure will come directly from an accumulation of shared user experience.


----------



## trophywench (Mar 16, 2015)

LOL - it's use in the UK would depend on large scale trials elsewhere in the world showing it was at least as good as, if not better than, all the normal injected insulins - and the other 50% if not more of the NHS decision would be based on price.

Have to say - a hell of a lot of people in the UK have the opportunity to be as well-controlled as Deus because we have really good education courses - and if people can't get onto these courses there are now enough of us that have, to try and pass on some of the info at least to other users.

And all without changing the brand of insulin people use.

If you don't have such courses available as a matter of course in the US, perhaps it would be better - if you want to help diabetics generally that is! - to campaign for them rather than spend a ton of money inventing something new?

Just IMHO, of course !


----------



## Andy HB (Mar 17, 2015)

I am not going to comment on the efficacy or otherwise of this product. What I will say is that any new product is better defined by is measured clinical use rather than its "buzz" on social media.

There are well established scientific methods to determine how good a product is (even if they are often abused by some unscrupulous chancers, but that is often apparent to those who understand such things). 

Just because something is new and sounds good, doesn't mean that it is.

I can heartily recommend a book "Bad science" by Ben Goldacre for anyone trying to get to grips with such things.

After all, snake oil salesmen are everywhere and they often sound very plausible (often including a kernel of truth within a big fat lie.).

Many people also swear by homeopathy, but whenever that is tested through properly controlled trials it comes out no better than placebo (taking into account those trials which seem to show otherwise...read that book I mentioned for a proper explanation!).

Finally, Scottamp (but for a missing "L", your name is a company that I used to work for), I agree that forums are a place for exchange of information and you will find that we are a friendly bunch. Doesn't mean that we necessarily have to agree all the time. Especially if the knowledge which is shared may be a little suspect and bears some examination.

Finally, finally, this is an interesting thread. 

P.s. I know my post can read like I am taking a pop at Scottamp. That is not my intention. I have no knowledge for me to do so. I am only stating concerns that I have with how some people operate.


----------



## Redkite (Mar 17, 2015)

ScottAMP, the thing that worries me is that there seems to be a "hard sell" going on to create patient (and health professional) demand for this product.  Unsurprisingly, nobody fancies the idea of injections, and I can well imagine vulnerable newly diagnosed people grasping at this non-needle alternative.  Equally, health professionals would probably prefer on the whole not to have to prescribe needles to their patients if there was an effective alternative.  Of course I worry about the effect on my son's lungs if he was inhaling insulin several times a day, but I would have the same concerns whatever age he was.  It can take years for side effects to become apparent.  It just seems to me that Affrezza is being relentlessly "talked up" by people with an inside interest in making themselves a profit; I've yet to see a word of praise for it from any objective medical professional.


----------



## ScottAMP (Mar 17, 2015)

Hi Jenny

The FDA trials in the US were designed to confirm that Afrezza was at least as effective as existing SQ prandials, which it achieved. The feedback post approval from its users is that when they have been allowed to deviate away from using it in a rigid way as was required for the trial, once they have found their own sweet spot they have significantly better BG control and that this feedback is inline with expectations due to the PK of the drug 

I agree that education is key and that this education gives people the opportunity to be as well controlled as Deus, although many are successful, many also fail for a variety of reasons. LCHF diets and discipline are probably an all around healthier way for anybody to live by including non-diabetics, but sometimes even disciplined people can and do fall off the wagon and sometimes this may even be on purpose, therefore if there is a solution or an additional tool that helps, perhaps due to the fact that it more accurately mimics native insulin performance post prandial ( then assuming any safety question marks and all other risk factors have been minimised or eradicated ) then this should be good for diabetic management across all forms; pre,post,T1 and T2.

In due course the prescribers in the UK will receive their sales pitches from the medical reps and then I agree that cost will probably be a key factor. Phase III clinical trials appear to be underway in the UK and it will not surprise you to read that within the proposed NICE appraisal there is consideration of the economic analysis

http://www.nice.org.uk/media/defaul...no-wave/Human-insulin-afrezza-draft-scope.pdf

It is extremely early stages post approval in the US and whilst I fully appreciate that the long term health effects can not be fully understood at this stage, assuming there are any. I understand that the absorption method is passive i.e. no chemical interaction, and as such laboratory research confirmed there to be no cell changes post use.

That said I was horrified with the swine flu innoculation / narcolepcy link as has recently been acknowledged, so I can and do accept the concerns as raised by Redkite. Perhaps the results of UK trials and the ongoing feedback coming from the US will obviously help to provide a more complete picture as we move forward.

As they say, you can fool all of the people some of the time etc etc, so as we move forward and more information is available then the picture will hopefully become clearer and known issues, however small will become visible.

Red kite, regarding the medical profession feedback, there is an email alledgedly from Dr Bruce Bode, MD, FACE ( worth a google ) in response to a question raised about the validity of some of the statements made by Sam Finca ( afrezzauser ) on his blog http://afrezzauser.com/afrezza-confirmed-by-doctor-as-real-deal/ and I am sure that as we move forward, additional proponents and opponents of Afrezza from the medical community will make their findings and feelings known; which can only be good with regards to an overall balanced view.

Andy, I will take a look at 'Bad Science' when I get a moment and I can assure you that your reply did not make me feel like you were having a pop in any way at all. 

We all have and are entitled to our opinions and the sharing of them and the discussions which follow are all part of being human and ultimately what makes for an interesting thread in the first place.  Although I do admit to taking exception to the initial lampooning I received for simply providing a link for Northerner, who from previous posts appeared to have interest in the subject matter.


----------



## DeusXM (Mar 17, 2015)

> I thought that the whole purpose of a forum/message board was to increase knowledge, share information and encourage debate.



Indeed. Are we not having a debate? Are you not sharing your information on Afrezza, and am I not sharing my information on Afrezza and years of having diabetes?



> initially I was a one off poster never to be seen again, then just an Al Mann cheerleader



And now you're a single issue poster who has never contributed anything to this board other than sharing your belief that Afrezza is a great product. 



> you did not like my use of the word ‘buzz’; even though this word was extracted directly from your original post ( 5th word )



Now you're being wilfully disingenuous. My objection wasn't to you using the word 'buzz'; it was to you claiming that buzz was somehow important and meaningful and a defence against my specific criticisms of Afrezza.



> in your most recent comment you were apparently heartened that I disregarded your legitimate concerns, which at no pointdo I believe I have done.



Unfortunately, you did. I've been very consistent in that my objection to Afrezza isn't to the product per se but to the fact that a phenomenal sum of money has been invested in it which I believe could have been better spent on a cure, and that I further objected to how there appears to a well co-ordinated campaign that attempts to shut down publicising this line of reasoning that also carries an unhealthy whiff of a cult of personality. You didn't actually engage with these concerns - you tried to dismiss them as apparently we're all fearful of things that are new...as you have a better understanding of what's really important for people with diabetes. I put it to you that, as someone with diabetes, I am marginally more qualified to express what at least one person with diabetes actually wants and I don't appreciate my objections being blithely dismissed as some apparent inherent conservatism, whereas it should be clear that my objection is actually what we've got isn't radical and new enough.

Simply put mate, I've stabbed my fingers something like 47,000 times and stuck needles in my thighs, stomach and butt something like 24,000 times. To suggest that I'm supposedly frightened by an inhaler is a bit of a stretch!



> However, you must concede that across the entire diabetic community there are a significant number who do have the same level of control as you, some do not have the same level of perfect discipline and perhaps they eat what they should not, when they should not and you must also concede that high and low blood sugars create health risks.



Of course I concede this! I live with those risks every single day. The difference is, as someone who lives with those risks, I believe the single most effective thing that can be done to help mitigate those risks is to invest in research for a cure for diabetes. I can accept there is an argument that new treatment methods allow us to be hopefully in reasonably decent shape by the time a cure comes. But what frustrates me is seeing the majority of cash being diverted away from a cure towards these patch-up measures. 

The question which frightens me and should frighten everyone who lives with diabetes is 'how much closer to a cure would we be if $1bn had been spent on cure research rather than a new insulin'? I honestly don't know. Five years? 10? 50? I admit this can't be quantified. But what I do know is there are clear clinical routes which are posited to cure diabetes that can't get enough funding and don't need anywhere near $1bn. I also concede that Al Mann is free to spend his cash as he likes but if his explicit commitment is to defeating the misery of diabetes then I put it to you that I'm entitled to be vocally critical if he then chooses to invest his money in something that distracts us from a meaningful change. Obviously, no-one has to listen to me though.



> perhaps you believe that my post was specifically designed to encourage everyone to blindly get involved and invest in what at this stage a highly speculative, small America biotech company, in a bid to increase my own return.



You almost had me until you described Mannkind as 'small'. It's a company run by a billionaire who makes massive investments to develop highly profitable companies. Please don't insult everyone's intelligence by trying to portray Mannkind as some clever disruptive start-up shaking up the market from nowhere armed with nothing but good intentions and a hat full of enthusiasm.

No, I don't believe you post was specifically designed to blindly get everyone involved, I think it was exactly what I predicted it would be - a dismissive reaction to a criticism from Afrezza aimed at trying to sweep that criticism under the carpet. Didn't I say I bet that someone with a track record of only posting on Afrezza and nothing else would pop up to defend it? 

Please also, don't feel like I'm particularly singling you out - you're part of a much larger trend. I posted some things on Twitter about Afrezza and who pops up? A bunch of people who post on nothing but Afrezza taking exception. I post on other boards, hey presto, one off posters suddenly appear to tell me I'm wrong. I post something on here and you magically appear after being dormant for ages - almost as if you are scanning forums to respond the moment someone posts something critical about Afrezza.



> It covers user experience, the pharmacokinetics and how it performs in almost an identical way that naturally occurring insulin peaks and declines. How this means the insulin only stays whilst needed and has pretty much cleared from the bloodstream by the time the meal has been digested (typically three hours) instead of leaving a long tail effect beyond this point and the inevitable stacking issues. This this may be why the same level of discipline with Carb counting, exercise and titration is required.



Nice try. I'll read the thread, but again, you seem to be mistaking my complaint as some criticism about the way Afrezza works. Again, I've been consistent in that my complaint is Afrezza isn't what we really want and to some extent represents a roadblock preventing us from actually getting us to a cure. I find it very hard to believe that I am the only person with diabetes in the world who looks at Afrezza and thinks "$1bn for a slightly better insulin? Couldn't that have been better spent on a cure?" and I resent the fact that this view seems to universally shouted down by people who seem to see Al Mann as some great hero who then also always seem to have some sort of financial interest in Afrezza. 

I'd feel much happier about Afrezza if there was a demonstration that it was part of a clear roadmap to developing some kind of closed loop system but it seems the sole goal of this investment was to create a product line that's marginally better than what else is out there with an aim of turning a profit. There's nothing wrong with that but please, please, please don't expect me to be grateful or respectful of that.


----------



## Northerner (Mar 17, 2015)

Very cogently expressed, DeusXM


----------



## DeusXM (Mar 18, 2015)

Just a few further points.

Firstly, take a look at this popular board:

http://mnkd.proboards.com/

A lot of interesting discussions here - interesting in that it's a peek behind the curtain at what investors in Afrezza REALLY think about us!

Firstly, the section on blogs and social media (where various investors evaluate the efforts of others who arrive on forums etc. to discuss diabetes) is very interesting reading - particularly when there's the discussions about certain individuals coming along too strong. Amusingly, there's also a post complaining about a blog that actually cites a comment I posted on another board. It's not paranoia if they're really out to get you!  

Plus, if you register, there's a whole subforum dedicated to how many prescriptions for Afrezza have been filed and various insights into which regions are doing well, what needs to be done to bolster the number of scripts etc. Fine, I get that investors want to maximise their ROI....but the juxtaposition of this next to another sub forum where users post about forum discussions with a view to getting their people involved....does this sound like these guys have the interests of people with diabetes at heart?

A quick readaround as well suggests that there is a certain amount of confusion among investors themselves as to whether Sam Finta is now operating in a completely impartial manner. No proof that he's being paid by Mannkind, but there are various discussions about whether he's been given permission (by who?) to post certain information. I continue to retain an open mind about the Afrezza user blog but who knows?

Then there's this link I found, which at least proves my suggestion that this might be something orchestrated by Mannkind is incorrect and I was wrong about that particular aspect.

http://seekingalpha.com/article/2902656-mannkind-investors-dont-screw-up-the-afrezza-launch

In other words, an investment expert basically begs Afrezza investors to stop posting on boards such as this one because it's spectacularly backfiring.

You have to register (free) to read the whole thing but here's a few selected quotes.



> Investors have been showing up at diabetes forums where they have never before posted posting messages telling visitors to those forums that they ought to be using Afrezza. Since these investors do not have diabetes, their posts don't connect with the questions people have posted and to which they were replying and harp on a supposedly miracle-working product, they look like spammers.





> investors who believe that Afrezza may be useful for people with diabetes should expect that they will be greeted with skepticism by people who have dedicated themselves to helping their peers with diabetes. More importantly, they should show respect for these people's skepticism.



There's also some interesting points made Sam Finta is NOT a typical user with some specific challenges (something I've actually already pointed out here). There's also this particularly interesting point:



> The time may come when the dosing studies that Sanofi is embarking on this year will be able to prove that Afrezza, when dosed properly, is superior to injected insulin for everyone who uses it, as it is for Sam Finta. But that day isn't here yet.



In other words....there isn't actually any proof (yet) that Afrezza is even a better treatment option for most people currently on insulin! I appreciate it's a wait-and-see and again, I'm prepared with an open mind....but doesn't this then further reinforce my massive concerns that so much has been spent on a drug rather than a cure attempt?


----------



## robert@fm (Mar 18, 2015)

The capital letters of ScottAMP's username are an anagram of what I, for one, think of his posts.


----------



## Andy HB (Mar 18, 2015)

robert@fm said:


> The capital letters of ScottAMP's username are an anagram of what I, for one, think of his posts.



Tee Hee! 

By the way, DeusXM, are you or have you ever been a member of a debating team?


----------



## bren8926 (Jul 4, 2015)

*My 2p Worth*

Hi, to answer some questions, from my research Afrezza is available as 4 unit and 8 unit doses.  It's more physiologic than injectable insulin and the body is able to take a greater part in balancing levels than it can for injectable insulin.  The problem with injectable insulin is that it floods the peripheral circulation and forces glucose into fat and muscle cells.  This is a one way street and can cause hypos 2 hours later if diabetes is controlled aggressively and post prandial (after eating) BGs are kept within range.  Afrezza gets to the liver in a higher concentration and this is the only place where glucose can be taken up and released thus helping to maintain and stable profile.  Furthermore if insulin gets to the liver in a higher concentration then the liver is less likely to release glucose as is the case with insulin dependant diabetics who suffer from Dawn Phenomenon such as myself. Due to the lack of insulin the liver is duped into thinking the BG is dropping and so releases glucose to compensate.  Does anyone else find that it's much harder to control BG in the morning after breakfast than at any other time of day.


----------



## bren8926 (Jul 4, 2015)

*Further*

Some folk here are worried about the costs to bring Afrezza to market and shouldn't we be investing in a cure.  I hope that I am wrong but I cannot see a reliable cure coming along for diabetes in the next decade.  Smart insulin is nowhere near completed.  Besides I wouldn't class this as a cure.  A cure means insulin independence.  I understand that Perle Bioscience are looking at Phase III plans in the States for 2 tablets, one to kick start the pancreas and one to target immunosuppression around the pancreas.  They are looking for quite young people who are newly diagnosed people with other qualifying criteria.  I believe this trial is taking place in Germany.  Bob Geho of Diasome Pharmaceuticals also had a very interesting discussion on TuDiabetes about the role of the liver in diabetes.  He is also Type 1 and I found his video chat extremely interesting.


----------



## DeusXM (Jul 6, 2015)

Oh look, another person who just joined and in the space of two days posted on nothing but Afrezza....


Interesting, I've read someone's testimonial that suggests because Afrezza is done and dusted so quick, it's actually quite ineffective for meals because they find that around the two hour mark, their blood sugar jumps up again, so they have to correct, which means they're spending far more time having to test and correct.

And guess what happened to that person after she posted on Twitter about it? A bunch of investors started piling in to her asking if she'd been hacked or whatever. 

http://mnkd.proboards.com/thread/2859/amy-tenderich-latest-twitter-make

By the way, as for there being no cure on the horizon...well, there's this actual cure that's now going into human trials. They still need a bit more cash because they need the phenomenal sum of just $25m...while people are blowing billions on an insulin which according to JAMA doesn't even offer better control. But that's because this cure is based on the off-patent BCG jab, so you can't make money off it.

http://www.eurekalert.org/pub_releases/2015-06/mgh-mgh060315.php


----------

