Farewell to Needles?? Breathe Deep…

I have been invited to join the Phase 3 clinical studies of MannKind’s Technosphere inhaled insulin. Exciting, ay? You can’t imagine what all’s going through my mind: Farewell to needles? (exceptTechnosphere_1 for the night-time Lantus) Just a puff and then snack-city! What kind of looks do you get in restaurants with a purple inhaler? Will I be one of the first to show lung deterioration?! And much, much more.

First off, I did my homework on the company, of course. Among the companies working to make inhaled insulin happen (Pfizer, Eli Lilly and Novo Nordisk), MannKind Corp. is considered the “dark horse.” According to this excellent “Motley Fool” article, the relatively small company would need to be acquired by a larger pharma giant to really make it in the long run.

But its technology is exciting because its powder-form insulin is absorbed rapidly into the bloodstream (for better D-control), and its compact delivery device is apparently the most handy and easy to use. No wonder MannKind’s known for innovation, since it was founded by “living legend Al Mann, who founded MiniMed some time ago, pretty much built the insulin pump market, and then sold the company to Medtronic for a handsome price.”

Nevertheless, the company won’t be filing for FDA approval of Technosphere until mid-2008. In the meantime, as Investor’s Business Daily points out, all the companies are studying “respitory concerns.” * cough! *

So do I sign up for a two-year study to help out? Will it make my personal situation better or worse? Even if I’m in the “control group” that ends up continuing on regular insulin therapy?

Here’s my list of considerations so far:

PRO
* If I’m in the active group, goodbye to injections!
* Helping the greater diabetes community by furthering important research
* Just a puff, and then a snack. Wow!
* Free stuff: all the examinations, insulin, and supplies are free (monetary compensation is tiny, hardly worth mentioning)
* If I’m in the control group, I can still go on the pump or do whatever I like — since the study is only comparing LUNG FUNCTION in the two groups

CON
* Lung damage — which they say is reversible, even IF it occurs (cough!)
* Other health risks — who the heck knows what this stuff can do to you over time? That’s why they’re putting on this study, after all
* The “Hassle Factor” — there are lots of doctors appointments, blood work, and even CAT scans involved (!)
* Locked in for 2 years (you can opt out, but ethics say you shouldn’t unless you experience real adverse effects)
* i.e. what if I just don’t like it, and decide I want to go on the pump at some point? Am I a quitter?

Anyone care to vote? What would YOU do?

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18 Responses

  1. Kassie
    Kassie December 9, 2005 at 8:35 am | | Reply

    oh what a dilemma!

    Before my first pregnancy, I entered a minimed study to see if pumps could help prevent the severe lows that pregnant women with diabetes experienced when battling morning sickness and adjusting to reduced (first trimester) insulin needs. To me, it was the quickest path to a pump, and it wasn’t very risky (the opt out was much more relaxed). I turned down a study that would have randomly given me an epidural or a spinal for my c-section (I wanted full strength blockage!).

    I admire and am grateful to those who are willing to try new treaments (in fact, I just wrote about that 10 minutes before visiting your site!), especially when there’s risk involved.

    Personally, this is not a trial I’d join only beacause inhaled insulin doesn’t appeal to me. But if it does, and if you can exclude yourself at the first sign of any adverse side effects, I’ll give you a resounding ‘maybe’. Probably. sure… what the heck! (And if you do, thanks for checking it out for the rest of us).

  2. Anil
    Anil December 9, 2005 at 10:17 am | | Reply

    I am still not on insulin, but the inhalable version sure sounds better than having a needle be injected into you.
    Needles are a personal decision. My mom has a hard time dealing with injections. She is so ashamed of injecting herself all the time that she hides to do it. Recently her doctor tols her that she can get off the insulin of she wants to. She is on tablets, but her sugars in the later 100′s. I do not htink that is good, but for her it is better than injecting herself. I would advice her to try this study out.
    What you are doing are the right steps. You have to evaluate the PROs and the CONs.
    Some other PROs are -
    1)Being able to control your insuling by sniffing as much as you need.
    2) No social trauma. Inhaling is more easier to do sitting in a restaurant.
    More CONs are -
    1) If it is really easy, you might start depending more on the insulin and let your diet and exercise get out of control.

  3. Andrea
    Andrea December 9, 2005 at 12:31 pm | | Reply

    Honestly, I’d have mixed feelings about this too. It would definitely appeal to me to get off injections or reduce the amount I need per day. I hate them with a passion. However, I’m not sure how I feel about inhaling insulin. Who knows exactly what it does to your lungs…and that scares me. Plus, I’m a pump user, so I really don’t have to inject that much as it is. The more I think about that, the more I think I’d veer away from this study. So I guess my answer would be, No- I wouldn’t participate in it.

    Whatever you decide, I wish you luck. Please keep us posted :)

  4. Kathleen Weaver
    Kathleen Weaver December 9, 2005 at 12:36 pm | | Reply

    I’ve done a couple of clinical trials for my doctor’s office — you’ve seen my notes on them. Those were mostly to help them figure out the dosages, side effects, etc.

    I have turned down the chance to do “real” clinical trials, the main reason was because I didn’t know the people involved.

    One of the reasons I’ll do this for my doctor’s office, is that I trust them and I know I can get out of the clinic trial if it starts going bad.

    I was diagnosed with asthma for a time (it was actually GERD), so no, people don’t think odd of you when you use an inhaler — not any more than when you use insulin.

    So go for it if you feel comfortable with it, otherwise, let someone else go for it.

  5. Kirk
    Kirk December 9, 2005 at 2:03 pm | | Reply

    If it isn’t broke why fix it. I do not care if I have to shoot up, I take my injections in public all the time no one ever seems to notice.

    I will change my routine when it will imptove my care/numbers/outcome. Just for convenience is the risk worth the benefit; only you can answer that question.

    What’s another shot except .002% of my lifetime total…………

  6. Megan
    Megan December 9, 2005 at 2:51 pm | | Reply

    This sounds so cool and like such an exciting opportinuity. Good luck with your decision.

  7. Ali
    Ali December 9, 2005 at 4:51 pm | | Reply

    I read recently that with inhaled insulin you have to inhale something like twice as much insulin as you would with injections to ensure you get enough? Is that right? It’d really be great if it is just a puff though.

  8. Keith Carlson
    Keith Carlson December 9, 2005 at 7:12 pm | | Reply

    Clinical trials are very important, but one must always consider the risk/benefit ration individually. It’s a nobel task to take on, but you have to be sure you’re willing to take those risks. It must be a very difficult decision. I hope you can come to some peace, no matter what you decide.

  9. PrintCrafter
    PrintCrafter December 9, 2005 at 7:31 pm | | Reply

    Hmmmm…that’s a tough one. I for one LOVE my pump. No way I’d trade pumping for huffing. On the other hand it is fun to be on the cutting edge. As you haven’t made the pump leap yet, maybe this is a better route for you?

    It’s not like you’re going to be the first person on the planet to inhale insulin, so I think the risk side of the equation is low.

    If it feels right (as a therpy) to you I think you should go for it.

  10. Breanna
    Breanna December 9, 2005 at 11:51 pm | | Reply

    Hi.
    I know its hard for us to realize the truth about studies and new drugs. And its sad to know that there is no real way to know how safe any new drug on the market is going to affect different populations. Sometimes we can only benefit from experimentation, and at one time or another, we will have to be a subject, to help benefit mankind. After all, we are benefiting from others who have come before us, who have participated in studies, or made an sacrifice. Now its our turn to contribute for those who will come after us.

  11. elizabeth
    elizabeth December 11, 2005 at 3:32 am | | Reply

    If there is one thing you don’t have to worry about is the huge amount of support you would get from all your fellow d-bloggers…

    I remember when my daughter was 4 months old and my doctor and I discussed my joining an islet transplantation trial. It was terrible…while I wanted to do it, the timing was all wrong. Because there were some risks with the surgery and post-surgical uptake – we decided my participating was unfair to this little person we had just brought into the world!

    I believe your partner and your children need to voice concerns and agree to the study…after that, you just have to follow your gut instinct.

  12. Florian Menninger, Jr
    Florian Menninger, Jr December 11, 2005 at 7:15 am | | Reply

    I interviewed at a place that was recruiting patients for the Clinical Trial by Mannkind. I decided not to go ahead with it after thinking about how I feel with a bad cold and lung congestion. Would I really be able to inhale the insulin dose when I was congested and felt like someone was sitting on my chest or would I resort to a syringe for an injection? The purpose of the study is to see how the therapy effects the lungs. A lot depends on the quality of the dry insulin powder. Did you know that Biocon is one of the largest producers of Insulin?
    I have been a practicing Type 1 for 38 years and I have injected a lot of insulin and tried a lot of different regimens. I am now trying to convince myself to try an Insulin Pump. Good luck if you decide to join the Clinical Trial.

  13. type1emt
    type1emt December 11, 2005 at 1:13 pm | | Reply

    not me- even if I weren’t on a pump. I have asthma, and with my luck I’d be the one to get lung damage. I’m sure you’ll make a wise decision and if the study has any neg. effects, you can always drop out.
    good luck!

  14. Will
    Will December 11, 2005 at 10:05 pm | | Reply

    Have you considered that they probably won’t let you write ANYTHING about your experience? Be sure to find out about that.

  15. CardioNP
    CardioNP December 13, 2005 at 8:36 pm | | Reply

    When I worked in primary care I had 2 patients on my panel who participated in inhaled insulin trials. Not sure which company it was as I was their PCP and not involved in the trial at all. Neither patient had adequately controlled sugars and I needed to tweak their oral meds. Neither patient was very compliant with diet/exercise, so can’t be sure it was the inhaled insulin that was the problem. But overall, I was not impressed with inhaled insulin based on these 2 patients.

  16. In the Pipeline
    In the Pipeline December 14, 2005 at 8:32 am | | Reply

    Grand Rounds

    Welcome to the latest iteration of Grand Rounds. On behalf of the greedy rapacious pharmaceutical industry, I’m glad to be hosting this week. Unfortunately for everyone, the research end of the G.R.P.I. is not immersed in the ceaseless flow of…

  17. Amir
    Amir December 19, 2005 at 11:43 pm | | Reply

    Any advancement in medicine is possible by some brave people just like you. This could be a very important and helpful way for using Insulin esp. in developing country. My mother who takes Insulin injection (She still has to use old fashioned thick needles and she hates it every time, it’s painful) has to take a cool box everywhere she goes and put her insulin inside with some ice and injecting is painful. I can’t send her new syringes from Sweden to her because Insulins are different and I can’t send her the insulin every now and then so these inhaling Insulins could be a miracle for her. I hope she would be alive until 2008 and can use this kind of Insulin at last for once.

  18. exuberaN
    exuberaN January 31, 2006 at 9:47 am | | Reply

    Pfizer now have the FDA Approval for the first inhaled insulin named Exubera. If you like smoke or resumes smoking you can’t take Exubera. If you have chronic lung disease such as asthma, you should not take Exubera.

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