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Is Robert Goldstein a moron?

Discussion in 'General Discussion' started by Ellen, Jan 27, 2006.

  1. Ellen

    Ellen Senior Member

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    Does the "Chief Scientific Officer of JDRF" have a CLUE about the day to day life of a person with type 1 diabetes? I am aghast and disgusted at his quote in this article! There are so many aspects of type 1 that are far worse than the simple injection of the insulin.

    My son will NOT inhale insulin.

    January 27, 2006

    Pfizer Wins F.D.A. Approval for Inhaled Form of Insulin

    By ANDREW POLLACK
    and ALEX BERENSON
    An inhaled form of insulin won federal approval today, offering the first alternative to injections for millions of people with diabetes since the drug was introduced in the 1920's.
    The product, which will be sold by Pfizer, could offer more convenience and less pain, though not necessarily better treatment of the disease, for many of the roughly five million people already using insulin, diabetes experts say.
    But it could also have a big impact on public health by prompting more of the nation's estimated 21 million diabetics to start using insulin, thereby better controlling their blood sugar and reducing the risk of complications from the disease.
    "The thing that people with diabetes who have to take insulin hate the most are shots," said Robert Goldstein, chief scientific officer of the Juvenile Diabetes Research Foundation International. "So anything that can replace shots patients are going to be very pleased to have."
    Pfizer's product, Exubera, uses a powdered form of insulin and a special inhalation device initially developed by Nektar Therapeutics, a biotechnology company in San Carlos, Calif., south of San Francisco. Pfizer, which said the product should be available in the middle of the year, has not announced a price for it, though drug industry analysts expect it will be two or three times as expensive as injected insulin.
    Exubera was approved for use by adults with either type 1 or type 2 diabetes and is designed to be used at mealtimes. Most people with type 1 diabetes and some with type 2 will still need to take one or two injections of longer-acting insulin every day.
    Development of Exubera was delayed for years because of safety concerns, primarily a slight loss of lung function among people who used the product in clinical trials. Deciding whether to approve the inhaled insulin presented a challenge for the Food and Drug Administration, which has been under criticism for allowing some unsafe drugs, like Vioxx, on the market.
    But an advisory panel to the agency recommended approval of Exubera in September, at least for patients without pre-existing lung diseases and the agency itself, after putting off a decision for three months, concurred.
    "I think that we and the advisory committees felt that there was very robust data with regard to the safety of the drug in patients without underlying lung disease," Dr. Robert Meyer, director of the F.D.A. office overseeing diabetes drugs, said in a telephone news conference this afternoon.
    But some experts say the risks of using the product day after day for life have not been ascertained.
    Because of the safety questions, Exubera was not extensively tested in children and is not approved for them. It is also not recommended for those with asthma, bronchitis or emphysema. Also, smokers or those who have quit smoking within the previous six months are not supposed to use the product because their lungs absorb too much of it, posing the risk of a dangerous overdose.
    The agency is also recommending that people who use Exubera have their lung function checked before they start on the drug and every six to 12 months afterwards.
     
  2. ctwetten

    ctwetten Approved members

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    Yep, that's VERY agravating! :mad: Shots are almost a tangential thing in my mind (not that I don't take them or anything; they're just not the half of it.) Someone should email him and clue him in.
     
  3. munchkingirl

    munchkingirl Approved members

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    Hey, Ya know, *I* AM a diabetic, and I have taken up to 12 shots a day - I think i also get to have a say in this.

    Yeah, that guy may not know what it is like to have diabetes - but - he also does work for the jdrf. He deals with it as well on a day to day basis. Shots DO suck! I am not going to put any blanket over it. I put up with them, i deal with them. I don't complain about them - they are apart of my life - they keep my alive. But - i do HATE them. I recently made the switch to the pump - 1 shot every 3-4 days and good blood sugars verses 6-12 shots a day and no garuntee of stable or good blood sugar readings. I am very pleased with the pump - and I do not believe that I would switch so quickly to such a new product after being so pleased with the pump (And NO way am I going back to shots if I don't have to!). I also need to point out - shots are great, it's sad that the inhaled insulin isn't yet garunteed to give as good of blood sugar control yet, however - what about insulin? When the animal insulin first came on the market it was the best way to control diabetes - not good in the slightest, but it was the best. Then came human insulin and 2 shots a day.. and so on. NOW we have ALLLLL Sorts of WONDERFUL things to keep us diabetics alive and living as normal a life as possible - having kids and everything. But, people are still trying to continue to better that (A WONDEFUL thing in my mind) and come up with better ways, less painful ways, less "weird" ways, and hopefully - someday - a cure. Part of that process is that new things have to come on the market and, though it may be unethical in out day in age (and I also think our standard of what's ethical and not is screwed up as well), there is some extent of trial and error to be had. Now, that doesn't mean that everyone needs to jump in on it - they can choose to let others do that, which is where I'm at. But i'm not opposed either to letting people try these new things.
    Personally, I am more of an adventurous person, I like to try new things - I don't always go with the "longest person in the buisness" kind of companies. I've got Animas - they're among the newer of the pump companies - but I am more pleased with them than any of the other pumps I have played with. So, it's all personel preference.

    I see no problem in this person at jdrf saying that injections are worse - he's probably heard so many more kids say they hate the shots than not. So, why not say that? It's true to the best of his knowledge and not his fault. Maybe he should be clued in, maybe not. That's a personal decision.
     
  4. Red (aus)

    Red (aus) Approved members

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    If someone with type 1 transfers to the inhaled insulin they still need to inject their long acting once or twice a day. It's not guaranteed to give as good control so for the moment people also have to correct via injection. So tell me how using inhaled insulin helps everyone get rid of their shots?

    My daughter is also a diabetic who started pumping a few weeks ago. However I asked her what she thinks and she hates hypo's much more than shots. She hates sick days much more than shots, she hates the fact that a simple cold can put her in hospital while her friends continue to live life normally with the same illness. She says shots may not be much fun but in reality they made her feel better.
     
  5. Ellen

    Ellen Senior Member

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    Robert Goldstein is paid handsomely to KNOW BETTER.

    It's not the syringe and 3 second injection that's the worst aspect of diabetes. It's everything that happens surrounding that shot...estimating how much insulin one needs, counting every carb that goes in the mouth, planning to carry enough glucose in the event of a hypo, planning to carry more insulin in the event of high blood sugar, ketones from not enough insulin, DKA, checking blood sugar with lancets many times per day, making sure you have enough glucose in your blood to safely drive, worrying about whether or not your blood sugar is going up or down, trying to take a test or needing to concentrate with too much insulin or not enough insulin on board, seizures, passing out and hoping someone around will know to give a glucagon, then puking, then knowing you need to eat and take insulin when you feel horrible, and fear of dead-in-bed syndrome. These are SOME of the worst apsects of having diabetes, not the little syringe injection.

    A chief scientific officer in an organization whose focus is to cure diabetes, should know better or be removed from the position.

    Injected insulin does not diminish lung function. Before you inhale insulin because you like to try new things...please do your research. What's next "diabetic lung disease?"

    http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169B1_01_01-Pfizer-Exubera.pdf 240 page document prepared by Exubera to the FDA . Big pharma yields tremendous power in the US.

    How small a drop in your airway test would be acceptable to you? Probes Efficacy, Safety of Inhaled Insulin -- Simmons 1 (1): 12 -- DOC News Research ...A "small but clinically insignificant drop" was observed in some of the airways tests, said Anthony Barnett, MD, the lead study investigator for Exubera

    Inhaled insulin for diabetes mellitus ...The efficiency of inhaled insulin is lower than that of subcutaneous injection because pulmonary delivery of insulin involves some loss of drug within the inhaler or mouth during inhalation. A concern of many clinicians is the possibility of long-term effects from the intraalveolar deposition of insulin within the lung, since insulin is known to have growth-promoting properties. The long-term safety of these products has not been established.


    Unlocking the opportunity of tight glycaemic control. Inhaled insulin: safety ...In clinical trials of patients with type 1 or 2 diabetes who were treated with Exubera((R)), the only significant clinical adverse effect was cough. This was generally characterized as mild to moderate in severity, decreased over time and was not associated with declines in lung function.

    [Inhaled insulin, new perspective for insulin therapy] ...Among various difficulties of the pulmonary insulin delivery, the finding of an effective promoter, capable of increasing the bioavailability of insulin, is a crucial issue. The cost of such insulin administration might also be a problem. Finally, careful studies concerning the safety of this kind of administration, particularly potential long-term pulmonary toxicity, are mandatory.

    University of Alabama, Birmingham UAB pharmacology researcher Dennis J. Pillion, Ph.D, “Inhaled insulin is fast and user-friendly, but precise dosing is difficult, and only about 10 percent of the insulin gets absorbed into the blood stream. And, like all new products, no long-term outcome data and toxicity data are available yet.” Pillion said.

    Persons with diabetes want to AVOID severe hypoglycemia. This is from an abstract of a recent Skyler article. Use of inhaled insulin in a basal/bolus insulin regimen in type 1 diabetic subjects: a 6-month, randomized, comparative trial. ... Inhaled insulin was associated with a lower overall hypoglycemia rate but higher severe hypoglycemia rate. ... Increased insulin antibody serum binding without associated clinical manifestations occurred in the inhaled insulin group. Pulmonary function between the groups was comparable, except for a decline in carbon monoxide-diffusing capacity in the inhaled insulin group without any clinical correlates.

    Read this one - it's important Exubera Efficacy In Type 1 Diabetes "Intensive" Glycemic Control Questioned By FDA ...Pfizer submitted its NDA (21-868) in March, after a delay of more than three years due to FDA concerns about cases of pleural effusion and pulmonary fibrosis during Phase III trials, as well as the appearance of Exubera antibodies.

    http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169B1_01_01-Pfizer-Exubera.pdf

    http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169B1_02_00-FDA-TOCTable%20of%20Contents.htm

    http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4169S1_00_Slide-Index.htm
     
    Last edited: Jan 29, 2006
  6. Sweetkidmom

    Sweetkidmom Approved members

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    *blink* *blink*
    wow, Ellen, you sure have done a wee bit o' research there! ;)
    Kay
     
  7. Ellen

    Ellen Senior Member

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    I don't know his salary but I would venture to guess it's :( several hundred thousand dollars per year? Do you think for that amount of money he should know MORE about the worst aspects of diabetes? He's one of the one's advising about what research should be done. So if injections are the worst, then once they get rid of injections, inhalable is a panacea and no more research needs to be done?
     
  8. munchkingirl

    munchkingirl Approved members

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    You are right, but, also - with sooooo many diabetics, do you really think that they'd let it rest at inhalable insulin? I personally don't think that they would. I sure wouldn't - and I know you wouldn't either.

    Also, in response to the others - yes, there are A LOT that goes into diabetes that makes it so shots aren't the worst thing. I was honestly not even thinking about those aspects - but yes, they do get VERY overwhelming. I really couldn't say, though, that there IS a worst. I also hate that A "normal" 24 hour flu could put me in the hospital. I hate that if I end up with a rather high blood sugar I "can't" participate in any athletics. I hate alllll the planning- making sure that I have EVERYTHING i need for the amount of time i'll be away from the home - then on top of that any extra's i might need. Such as today - I am out of a job and searching for one. I have *no* money on me at all and my blood sugar went low AND I forgot to grab some sugar stuff from home. - problem. Yeah, i hate all that. But, I still think that the inhalable insulin shouldn't be so quickly thrown aside. I, currently, will not dump my pump for inhaled insulin and a shot or two of long acting. I would rather have them come up with better things first, i am quite satisfied with my pump. And as it stands - I would rather have a cure or something even closer come first. BUT, i think that the inhaled insulin may be a really cool substitute for 4+ injections a day with long acting, for those people who are excited to try it. Yeah, there are probably still bugs to be worked out of it - but that's what has happened with most things, even our wonderful insulin pumps have recently had bugs to be worked out. It's all a matter of perspective, I guess.
     
  9. Boo

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    Personally I don't find that comment so offensive. I don't necessarily agree with it either...shots seem to be just one of the many negatives (heck, those lancets hurt more!) Reading a quote without the entire context of the interview/conversation can be a dangerous thing, and is often misinterpreted. I believe (or should I say hope) that a man in a position such as his would be well versed on the goals of the Foundation (namely a cure), but that doesn't mean that they can't also work toward improvements. I am sure that there are many diabetics that might eventually benefit from inhaled insulin...maybe not type 1's, but perhaps older insulin dependant type 2's who are afraid of needles and/or who have eyesight too poor to draw up their own syringes.

    I find it encouraging that scientists are exploring potential ways to make it easier to live with this disease. However, until much more research is done, and improvements are made, we'll stick with the good old-fashioned injections for my son (at least until he decides he is ready for the pump!):)
     
  10. Ellen

    Ellen Senior Member

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    http://www.jdrf.org/index.cfm?page_id=104531

    JDRF Statement on FDA Approval of Inhaled Insulin
    On January 27, 2006, the Food and Drug Administration approved Exubera, an inhalable form of insulin developed by Pfizer, for use in adults. Inhaled insulin may provide a number of benefits for people with diabetes, including the elimination of some injections, more rapid delivery into the bloodstream via the lungs (as opposed to subcutaneous tissue via injections of the pump), and convenience. This could help patients improve blood glucose control, the most important factor in reducing the risk of diabetic complications.
    While JDRF supports the development of therapeutics such as this that can improve the lives of people with diabetes, inhaled insulin is not a cure and won’t replace the need for people with type 1 diabetes to take daily injections or to continue closely monitoring blood glucose levels. Exubera was designed to be taken mostly at mealtime to provide short-acting insulin, rather than to provide insulin throughout the day. Further, Exubera was not tested in children and has not been approved for use in children. Finally, there are a number of safety concerns raised during the review process that are still being addressed.

    While Exubera represents an exciting step forward in insulin delivery, enthusiasm should be tempered with caution as these concerns are addressed. Initially, Exubera may be more appropriate for people with type 2 diabetes, who resist insulin injections and, as a result, do not maintain tight control. In the future, however, inhaled insulin may provide a convenient and less painful alternative to insulin injections for people with type 1 diabetes as well.
    Type 1 diabetes is an autoimmune disease in which the body’s immune system attacks and destroys the insulin-producing cells of the pancreas. It usually strikes in childhood, adolescence, or young adulthood, but lasts a lifetime. People with type 1 diabetes must take multiple injections of insulin daily or continuous infusion of insulin through a pump just to survive. Insulin, however, does not cure diabetes, nor does it completely prevent its eventual and devastating effects: kidney failure, blindness, nerve damage, amputations, heart attack, and stroke.
     
  11. munchkingirl

    munchkingirl Approved members

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    Well see, there we go. They are not hiding anything. They are coming right out and saying that it's 1) not approved for children 2) still some safty concerns 3) it's not designed to replace injections 4) more for those type 2's who don't want injections - to reduce their risk of allll those "wonderful" diabetes complications.

    There is nothing wong in saying your son won't inhale insulin - I won't either. However, for me that is simply because I'm satisfied with my pump and don't see going back to some injections with inhaled insulin as a better alternitive. Although, I must say that if I didn't have my pump - I would definitely look into getting some inhaled insulin - yet as boo said, I'd still wait awhile for more improvments and research to be done.

    Yeah, they are just one of many negatives about diabetes - and the jdrf and other organizations are working to eliminate one of them. I think that's fantastic!

    - VERY much agreed! ;)
     

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