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Understand the risks before you or a loved one inhales insulin

Discussion in 'Parents of Children with Type 1' started by Ellen, Jun 27, 2014.

  1. moco89

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    Another huge problem that has not been mentioned yet in this thread is the inherent absorption issues with inhaled insulin.

    The insulin has to pass through various orifices in the body and also mucous membranes, which will lead to large variations of absorption, no matter the consistency of the inhalation technique used and no matter how well the inhaler is designed to reduce this risk.

    By the way, I have a very complicated medical situation, and I have medical conditions not related to my diabetes that compromise my control a lot. Because I am desperate for being as "healthy" as possible and for having decent control, I am strongly considering this option, even with the risks, such as decreases in lung functioning.

    In my very personal opinion, inhaled insulin has "bad idea" written all over it, but I am still desperate to try something to improve my overall health and functioning. Desperation can definitely cause a person to make bad decisions with serious consequences. I don't want to be one of them, so I guess I need to keep things in perspective, and not be a "guinea pig" and just wait awhile.

    Anyways, I am more of a fan of technological innovation, rather than pure biological or pharmaceutical innovation anyways. I strongly believe that a predominately technological cure has more potential of curing diabetes than a pure biological one, because eventually technology will likely allow us to supersede our biological limits. From that respect, I do believe BioMEMS is potentially the most likely way type 1 is going to be cured (although not technologically possible at this time) through the encapsulation of islet cells. Do not ask me how the encapsulation will be possible, but I am convinced that a diabetes cure is technologically possible with BioMEMS, around 20-30 years from now (when it is expected to be theoretically prevalent and possible).
     
    Last edited: Jun 28, 2014
  2. Joa

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    In case of the former inhalable insulin by Pfitzner (Exubera®) the pre-approval studies showed that the inhaled insulin was increasing the levels of insulin antibodies I(A)A very significantly compared with regular insulin admistered sc. see page 59 at bottom

    A explanation could be, that inhaled insulin need a much higher concentration of insulin molecules (Exubera was about 10x as far as I know) and the place of resorption is quite more unnatural as the subcutaneous tissue. Both may be a trigger leading to more reaction of the immunological system.

    Are there data known what Alfrezza is provoking in such sense?

    Regards
    Joa
     
  3. rgcainmd

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    Yet another potential reason why we won't be using Afrezza any time in the near future (maybe ever). The last thing we (or anyone) need is worsening auto-immunity!
     
  4. Christopher

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    Firstly, Joa is talking about Exubera, not Afrezza. Two different drugs that may have different mechanisms of action and different effects on the body.

    Secondly, Joa failed to mention that the document he cited also stated that "The results provided no evidence that the increased antibody levels in INH-treated patients affected postprandial glucose tolerance or prolonged the duration of action of inhaled insulin."

    Thirdly, Joa's statement that ".......may be a trigger leading to more reaction of the immunological system." is complete conjecture on his/her part and he/she has not produced any clinical evidence to back up that claim (whatever it means). For you to imply that Afrezza is "worsening auto-immunity" is just misleading and unsubstantiated.

    I find it interesting that in another thread you got all bent out of shape when people were posting their personal (negative) experiences with the Omnipod, yet here you are jumping to unsubstantiated conclusions about a drug you have never used and feel the need to let all of us know you will probably never use it. Being a Dr. I would think you would show more objective thinking and expression. But clearly, you are entitled to your opinion and are also entitled to express it here and I respect that.
     
    Last edited: Jun 30, 2014
  5. sszyszkiewicz

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    From Mike's excellent article:

    "So far it’s cost a whopping $1.8 billion (!) to get Afrezza to this point, and much of that money was used to pay for 60+ clinical trials that have involved 6,500 patients. Wowza!"

    That is Billion with a B folks. as in almost 2,000 million dollars. 6,500 patients. 60 different clinical trials. Not a single dollar of taxpayer money. This company went up against the status quo, played by their rules, and made it.

    If I were a T1D I would use it tomorrow, just to try.
     
  6. rgcainmd

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    My bad. I jumped to an assumption that there was a potential risk of increasing levels of insulin antibodies to inhaled insulins in general. Without reading the article Joa cited. Big mistake.

    I might be a doctor, but I'm a mother of a CWD first and foremost. My knee-jerk reaction to a drug whose risks include pulmonary carcinoma is "not for my kid". Of course, there are risks with every drug on the market, some of them quite serious. But the ones I'd consider having my child take have been used in the general population for a significant period of time. I don't actually need to take or have my child take a medication to have an opinion about it. I forget who originally said this, but here goes: Opinions are like a$$holes; everyone has one.

    In addition to what I posted above, another reason I'm not feeling tempted to try Afrezza is because (at this point in time) there isn't a burning need for an ultrafast-acting inhalable insulin in my daugter's treatment regimen. Knock wood, we've experienced only one instance of a sustained high that even rage-bolusing didn't seem to touch, and that was one day prior to when my daughter came down with a gastrointestinal virus. I'm pretty certain this will change with time and we will end up needing something like Afrezza in our diabetes toolbox, but we'll jump off that bridge when we come to it.
     
    Last edited: Jun 30, 2014
  7. Michelle'sMom

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    http://www.healio.com/endocrinology...ewly-approved-inhalable-insulin?page=0&Filter

    In light of the recent FDA approval of the inhalable insulin powder Afrezza, Endocrine Today called on board member David S. H. Bell, MB, FACE, of Southside Endocrinology, Birmingham, Alabama and retired professor of medicine from the University of Alabama School of Medicine, to see what patients might want to know about the drug.
    Afrezza (MannKind Corp.), an inhalable mealtime insulin, was demonstrated to effectively reduce postprandial Hb1Ac in combination with basal insulin. It is not the first inhalable insulin available to treat diabetes; Exubera (Pfizer) was approved by the FDA in January 2006. The packaging was updated in 2008 to reflect revised data showing increased lung cancer risk.

    David S. H. Bell

    Bell anticipated some questions patients may have as the drug moves toward production.
    Top questions from patients
    Q: If I smoke, can I use inhalable insulin?
    A: No. Bell and the press statement from MannKind Corp. both urged that the drug should not be prescribed to smokers.
    Q: If I have asthma, chronic obstructive pulmonary disease (COPD) or other chronic lung conditions, can I use Afrezza?
    A: No. According to the press release, the Afrezza box will carry a warning stating, “Acute bronchospasm has been observed in patients with asthma and COPD using Afrezza. … Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD.” Physicians are urged to perform a detailed medical history, physical examination and spirometry to identify undiagnosed lung disease, the press release said.
    Q: Do I need to pass a lung function test before starting the drug? Will lung function tests be required regularly during my use of this drug?
    A: Yes, patients must pass a lung function test, and yes, these tests should be repeated at a regular interval to ensure normal lung function as advised by the package insert, according to Bell. The press release from MannKind Corp. recommends doctors “assess pulmonary function (e.g., spirometry) before initiating, after 6 months of therapy, and annually, even in the absence of pulmonary symptoms.”
    Q: What are the side effects?
    A: “The most common respiratory side effect experienced with Afrezza in trials was a mild, transient, non-productive cough. Discontinuation due to cough was uncommon,” a release from MannKind Corp. stated.
    Q: How much will the drug cost?
    A: “MannKind Corp. will finalize pricing in collaboration with their future marketing partner, but they anticipate that Afrezza will be priced comparably to rapid-acting analog pens,” a representative of the biopharmaceutical company told Endocrine Today.
    The big question from physicians
    Q: Does inhalable insulin therapy increase the risk for developing cancer?
    A: A 2008 update to an earlier inhalable powdered insulin (Exubera, Pfizer) showed that the pharmaceutical company acknowledged that treatment resulted in increased occurrence of malignant lung cancer. The product’s packaging was updated to note that all patients who used Exubera and subsequently developed lung cancer had a history of cigarette smoking.
    “Remember insulin is a growth factor. When you’re putting insulin into the lungs, it may well accelerate growth. Remember Exubera. Part of the reason everyone thought it would come off the market was because the device was big and awkward. But there may have been another reason, too; Pfizer showed there was an increased risk for cancer,” Bell said.

    Bell said the packaging and device that delivers the powdered insulin is an improvement on the Exubera device. “It’s a nice little appliance.”
    “We’ve had injectable insulin for 90 years. It has worked well,” he said. “Throughout the years we’ve experimented with insulin eye drops, nasal insulin, encapsulated oral insulin and even vaginal and anal suppositories. All of these things have never really worked out. Now, we’ve got a very convenient, painless system to administer insulin, especially with insulin pens and their 32-gauge needles. Frankly, I don’t see the need for this.” — by Reagan Copeland
     
  8. rgcainmd

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    I'm probably being dense, but in reference to Bell's statement, I'm not understanding his last sentence: "Frankly, I don't see the need for this."

    The need for what? Injectible insulin? Insulin eye drops? Nasal insulin? Encapsulated oral insulin? Insulin in the form of suppositories? Inhaled insulin? Questions about Afrezza?


    ETA: Perhaps instead of the question "Does inhalable insulin therapy increase the risk for developing cancer?" a better question (and one that may have lead to a more direct answer) might have been "Does Afrezza inhalable insulin therapy increase the risk for developing cancer?" The answer to the latter question is of infinitely greater importance to me than the fact that the device that delivers Afrezza is "a nice little appliance."
     
    Last edited: Jul 2, 2014
  9. mamattorney

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    I feel similarly. First off - the needles aren't painless. That's just a lie. Less painful than lower gauge needles, yes. But they aren't painless. The pain is the main reason researchers have tried to develop insulin eye drops, nasal spray, and oral versions -- because people want a pain free delivery system. You don't see scientists trying to create nasal spray tylenol, because there truly is no need for that.
     
  10. rgcainmd

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    FYI, Gary Scheiner addressed the subject of Afrezza on his live interview from FFL on tudiabetes today. Amongst other comments, Gary described Afrezza as "gimmicky."
     
  11. MomofSweetOne

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    My concern is that the possible damage may not show up for years - decades - which could leave the kids with another crucial organ not functioning right.
     
  12. shannong

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    One of my biggest challenges is the high bg spike my son can have in record time and the fact that I just don't have an insulin that works fast enough. It definitely has me interested.
     
  13. mmgirls

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    I do understand your reasoning to "want" an insulin that is faster, because I do to for certain situations too. But I knowing how long we are now living on this earth I would hate to damage my kiddos lungs, something that may not show up for decades if not more.

    Personally I would leave this sort of insulin delivery device to my adult child to decide to use.
     
  14. rgcainmd

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  15. bbraxton

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    I have to be honest. People are always afraid of the unknown. I have been on contact with some one who was part of the clinical trials he had nothing but glowing things to say about Afrezza. He keep his glucose in the 120 ranges for several days in a row. This insulin is not like anything on the market. It is mimics one's own natural insulin curve. It peaks in about 18 minutes and out in about 1 hours. It has been used by well over 5000 people for 10 years the cases of cancer were with two people who were heavy smokers(know cancer causing habit). Diabetes have side effects as well and one thing that is now coming out is today's insulin which are NOT fast enough leaving people out of range way to long and even a great A1C can be misleading as it maybe the results of to many lows and to extreme highs and not really because of great control. Just Google Afrezzauser and see all he has to say about it. He even told me his long function improved. Of course they can not advertise this as a side effect, they only can mention adverse side effects. It will probably be available for children in 2017. I am posting a response from some one who had a great experience with Afrezza. He even has a video on you tube on the inhaler.

    "Good question. Actually my lung function went up. Trust me I cut up with the physicians at the lunch facility and I took 5 tests. Not only my lung function was off their scale but it rose. There has been over 5000 people that have been on various trials for mnkd ...There are still patients on afrezza for over 5 years that switched from exubera to afrezza so I am certain there are 0 issues.

    To be honest even if it would take away 3% lung function i would do it to get rid of my lows and this daily nightmare of dealing with it. Just saying as an example as it does not do that.

    FDA already requested phase 4 trials on kids as young as 4 so you should get your wish.

    I am not sure if you have read my dozens of postings on yahoo over the last year but think about this....

    Being on Novolog or Humolog for me is like you are not leaving in real time. You never know where your sugar will be in 3-4 hours. If you have a child in school they take insulin at breakfast their blood sugar will still be pushed down passed school lunch time and now they have to take more insulin. If your kid ever has a low in school you can pretty much count on them to be called freaks for years to come. So what is the alternative?

    I wake up at 7am cehck blood sugar...lets say it is 130...I take one cartridge of afrezza with breakfast. Afrezza kicks in at the same time my meal digests....I check blood sugar at 7:45am and if its 80-140 I am good to go till the next meal. Why is this ? Because there is 0chance of me getting a low as 90% of the insulin is out of my system in 30-35 minutes. Trust me i ran my own tests on the side over the 6 months. I had this down to a science. No planning meals. So what if your sugar is high? One time i went ot eat pizza and left my inhaler....I told my friend it dont matter cause by the time i am home i can bring my sugar down in 20 minutes. I go home blood sugar 295 in 20 minutes I dropped it to exactly 100.

    I cant wait....I have lows every week currently and on afrezzz i had 0 severe lows in 6 months. Thats what kills us! I had no more worries at nights......its so simple too becuase you can give you child one cartridge for their meal in school and there is no way to overdose! If my son had diabetes i would never sleep...I would never trut them with an insulin pen knowing it can kill them

    I am on antohter trial for another company and wore a dexcom monitor. You can set alamrs for lows and highs and you dont even know you are wearing it. In my opinion once I have afrezza again and wear a dexcom monitor I will have a1cs in the 5s without risks.

    On way out...If you have more questions let me know."

    One last thing I want to say is comparing this insulin is like company the old slow insulin to yestedays insulin. It is apples to oranges. This is a game changer and like NOTHING on the market today, which is why the JDRF is using it with the AP. Because it is so fast.
     
  16. Joa

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    Thank you for the link. That is leading to an answer to my former asked question relating to anti body genesis.

    The article links to study results (side 144, pt. 9.1.8) showing that Afrezza is provoking higher antibody levels, comparably to Exubera, in T1D.

    That is not really surprising because the active component of both drugs is just the same. Human insulin molekules and both drugs are admistered pulmonic.

    For me I conclude that (human) insulin given over the lung is provoking higer AB (antibody) levels than insulin injected sc.
    Just an other point to think about. The question why is not the critical point. The reality "that" is the fact.

    That the increased insulin antibodies in case of Exubera were found not to impact (noticeable or significant) the therapy is not unnormal. My question aimed at possble long term effects of a higher stimulated immune system.
    In a small number of cases it is documented, that there is a risk of severe insulin resistance due to anti-insulin antibodies.

    Regards
    Joa
     
    Last edited: Jul 13, 2014
  17. mmgirls

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    Are they the same anti-bodies? injected insulin and inhalable?
     
  18. bbraxton

    bbraxton New Member

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    Really "All insulin products can elicit the formation of insulin antibodies." http://www.rxlist.com/lantus-side-effects-drug-center.htm. ALL medicines have side effect so does the current insulin. Who is to say a faster acting inject-able insulin won't do the same thing? Has anyone looked at the positives? I have and they far outweigh the negatives.
     
  19. Joa

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    In both cases it are anti bodies against the human insulin molecule, better said against epitopic caracteristics it is showing.

    Regards
    Joa
     
  20. adrien

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    Actually it says "substitute for long-term insulin use". That I can only take to mean that it's not a substitute for long-acting insulin.

    As for the warnings, it's saying don't use if you are athsmatic or have chronic lung obstructions. Well is that really so surprising?

    But for everyone else, there's now something that will hit their bloodstream in seconds. I think this will be great for lopping the tops off of BGL peaks.
     

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