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• 6/11/2008 7:40 AM TechRightGuy wrote:
  Allie, you have found the smoking gun! Amazing, just amazing. This defies belief. It also appears to open the 3 musketeers to a class action lawsuit, at the least by those who now have insulin-dependent Type 2 diabetes.
  
  --Steve
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  1. 6/11/2008 9:34 AM Jeff wrote:
     The sad irony of this is the fact that just yesterday, Bloomberg News ran a story entitled "Novo pushes for early use of insulin" by Frances Schwartzkopff about how Novo Nordisk A/S is is using its clout as the world's biggest maker of insulin to promote early use of the product (among patients with type 2 diabetes) in an effort to reverse decades of medical practice in treating that form of diabetes.
     
     Perhaps that is just the action needed to implicate the industry's dirty behavior?
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• 6/11/2008 10:43 AM BetterCell wrote:
  The majority of people with T1DM or IRD(aka Type 2 Diabetes) will NOT do anything unless it is too late.............and then it truly is too late or
  their Physician in the long white lab coat has told them to.
  As far as changes in product formulary regarding Insulin Manufacturers............why would they want to change anything regarding GM Insulin, when the AMA, ADA and others have already decided that it is a numbers game with A1C's. They do not acknowledge that there might be a relationship between lack of C-peptide(found only in animal-derived Insulin) and Diabetes related Complications. The Status Quo and weekend picnics/golf games have to be maintained over the possibility that there might be something *amiss* with GM Insulin.
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  1. 6/14/2008 7:27 PM Allie Beatty wrote:
     The ironical truth behind the “A1c” theory is this:
     
     For Type 1 – the more “analogue” the patient uses the more activity loss from their beta cells i.e.) faster destruction of any residual beta cell activity and C-PEPTIDE (preservation from diabetes complications).
     
     This just so happens to be the magical equation for forcing Type 2 diabetes (as you refer to IRD or “Insulin Resistant Diabetes”) into beoming insulin-dependent diabetics.
     
     What do the 3 musketeers care?They banked over $3.3 billion in 2006. They extort money out of patients, insurance companies and government programs to cover their deceitful, destructive, and dangerous “bad medicine”.
     
     I don’t believe the 3 Musketeers should be allowed to get away with this scientifically designed destruction any longer. I think patients with insulin-dependent diabetes should INSIST on their doctor regularly checking beta cell health with a stimulated C-peptide test and giving them a CHOICE of  natural insulin option like beef or pork or genetically modified analogues . Once a patient has experienced the CHOICE will they know with CERTAINTY if analogues are therapeutic or TREACHEROUS to beta cells.
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• 6/11/2008 11:22 AM TheScream wrote:
  "After all is said and done, more is said than done." If this type of information comes to light and is proven factual, then it is high time to declare war on any and all entities who are compromising the quality of life for those already living with the challenges of T1. Again, if these allegations are proven true, then class action lawsuits, exposure, and any thing else to get the word out there to right these wrongs is justifiable. "All is fair in love and war." If our children and young adults are being sabotaged, then I say let's stop talking and declare war on the enemy.
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  1. 6/11/2008 5:30 PM Brent wrote:
     Good find, Allie. This, along with the fact that there is increased incidence of hypoglycemia unawareness, cancer connections (in European literature), increased complications, and a compact, peaky nature to all of these new analogs, we are all enslaved by a very expensive monitoring system.
     
     The problem for the last 20 years has been that no law firm in this country is willing to take on the vast pharmaceutical fortunes and their armies of lawyers. One very well-known lawyer told me the biggest drawback to T1 diabetics being abused by the insulin cartel is the fact that the very NATURE of diabetes is such that there are no "common denominators" for the problems caused by faulty drugs. In other words, a class action lawsuit relies on COMMONALITY of ‘harm’; in the case of diabetes, we die from unforeseen auto accidents, industrial accidents, kidney failure, heart disease or, heaven forbid, we die suddenly, after strenuous exercise or while sleeping. Diabetics die from TOO MANY miscellaneous results, even though our insulin protocol may be the common denominator in many cases. I and several friends have talked to some of the most prestigious law firms in the U.S. . . . and all have said the insulin cartel has the perfect (and one of the most dangerous) drugs administered by patients themselves. Consequently, no one is to blame BUT THE PATIENT when the insulin kills him or her. Beyond that, I have even tried to interest the Federal Trade Commission, the lawyers who engage the FDA, the ACLU, public interest advocates, and anyone else who might listen to be aware that the FDA approved a harmful drug that is killing thousands of diabetics. The advertising we read every day about these insulins is founded on half-truths at best.
     
     If George Bush can ignore our Constitution, with plausible deniability, the inside-the-beltway attitude (lobbyists/legislators) must consider a few thousand dead diabetics as acceptable collateral damage when weighing them against "free market" corporate profitability and "progress." Bush the First championed Eli Lilly, and selected Dan Quayle as his vice president. The Indiana-connection probably went far in aiding Henry Miller in pushing through approval for this ‘most dangerous drug.’ Don Rumsfeld, another Bush-the-First crony, headed G.D. Searle at the time aspartame toxicity was being bandied about in scientific literature. Nevertheless, he (with help?) successfully navigated regulatory hurdles, and gained approval for this known neurologic toxin—targeted primarily at the obese and the diabetic.
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  2. 6/14/2008 7:38 PM Allie Beatty wrote:
     Hey TheScream,
     
     Sad but true – the only way to measure beta cell health / destruction is to start from the “get go”: do my beta cells secrete ANY c-peptide before I begin exogenous treatment? After starting insulin or analogue treatment – is this repairing my beta cells or catalyzing destruction? The simple STIMULATED C-peptide test has been available since the 1970s but doctors have selectively exempt it from standard “diabetes treatment” since the introduction of Humulin insulin in 1983. ::::Church Lady says::::: WELL ISN’T THAT CONVENIENT??!?!?!? It seems that Pharma Reps explicitly advised doctors that "it's just like the human body makes". Actually -- that statement is physiologically and scientficially INCORRECT. I'd say that the premise of a billion dollar class action suit!
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• 6/12/2008 6:36 AM Melody wrote:
  Allie--
  
  The smoking gun is a great find! If you read the NDA that Lilly submitted to FDA, and the notations made by FDA when they sent Lilly an "approval" letter, you would be even more disturbed. The 'test' populations used for the various assays of their new 'wonder' drug were extremely small; and the only meaningful metric was that the product lowered blood glucose . . . and didn't cause IMMEDIATE observable harm. That plan has worked very well. By dint of precedent, it appears that any new insulin-like analog is measured against this very low bar . . . and the most amazing fact is this. If the product can be introduced into the diabetic body without immediately harming or killing the patient, then any future harm is laid squarely at the feet of "the disease" or "the patient." What a perfect roadmap . . . brought to you by the insulin cartel, approved by your FDA, and pushed at you by your 'concerned' physician. Is anyone else disturbed by their inclusion as unpaid, uninformed, non-consenting GUINEA PIG?
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• 6/12/2008 9:07 PM Glenn V. wrote:
  Hello Allie, please enjoy your vacation and thank you for trying to spread the word out there for the unsuspecting new Diabetics who have no clue as to what is really going on with their lives. Nature is the only way to go in my opinion and I have refused to listen to my doctors and others and I have been on both sides of the fence and know that natural insulin is the only insulin that truely works and works well in keeping me alive. I could not live on the other so called insulin and I know that for a fact. It would be nice to have a side by side comparision of side effects and other issues and really look at this from a objective point of view. But when profit is involved instead of Patient care well guess who wins. MONEY. Follow the money and see just where it leads and you hit the nail on the head. Anyway take care and enjoy your vacation and relax this will help too. It is sad when money becomes more important than peoples lives but this is the world we live in. Take care and have fun.
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• 6/13/2008 1:42 PM TechRightGuy wrote:
  Allie:
  Can you off comment/critique on this item, in light of your discovery discussed above?
  
  http://www.diabetesincontrol.com/results.php?storyarticle=5794
  
  Much appreciated!
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  1. 6/14/2008 8:46 PM Allie Beatty wrote:
     Thanks Steve – great study!! Let me take a stab at it...
     
     My lay interpretation of this study is that 51% (possibly 92%) of the 381 patients were experiencing transient elevated glucose to begin with. This means that if they had remained “untreated” the approximate 4 to 7 days they spent on diabetes treatment would have produced the same outcome without treatment. The morning fasting blood glucose of 126 mg/dL is not a fair threshold to diagnose DIABETES.  
     
     Was there a control group in this study? I.e.) no treatment whatsoever? I also wonder what the diagnosing HbA1c was – and what it was when the study subsided.
     
     This study without a control is nothing more than a RUSE to justify the new Novo Nordisk A/S campaign for insulin treatment for Type 2 – another diabetes marketing scheme.
     
     The “hook, line and sinker” is the fact that a patient starting insulin therapy is not likely to see his or her doctor for at least a month after starting the new regime. It is likely he/she will continue on the analogue for 30 days. By that time – the body will have begun creating insulin antibodies to assist in destroying the any endogenous insulin production – therefore REQUIRING the analogue dose to increase. This foreign analogue will also create the insulin receptors to shut-down to prevent HYPOGLYCEMIA . Believe me when I tell you - HYPOGLYCEMIA is far more traumatic to the body than hyperglycemia. Remember - those who still have functioning beta cells have C-PEPTIDE TO PROTECT A BODY FROM COMPLICATIONS OF DIABETES .
     
     It is a common phenomenon for many Type 2s to begin on a dose that gradually doubles and even TRIPES. This could be evidence that endogenous insulin production is overridden by analogue therapy. A stimulated C-peptide test could confirm this hypothesis. The bottom line here is: less endogenous insulin production means less C-peptide and more vulnerability to the complications of diabetes.
     
     [On any given Sunday - a person who does not have diabetes can have a blood glucose of 50 mg/DL or 500 mg/dL. The reason they do not experience complications of diabetes is because their beta cells function! Analogues override and prevent the healthy function of beta cells.]
     
     I never said Big Pharma was stupid – in fact they’re just brilliant at marketing studies to sell their products. I just hope this one doesn't dupe medical professionals the same way the "Humulin" insulin campaign did in 1983.
     
     Increasing diagnosis, increasing complications, and higher costs -- who's benefiting here?
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• 6/13/2008 2:48 PM Sanktpauli wrote:
  A nearly undetectable way to murder someone is to give him an injection of bee venom and then distance yourself from him and wait. This initial injection will cause the body to produce a huge stock of anibodies against bee venom. Then some day, perhaps many years later, when the person is stung by a bee, the bee venom injected will interact with the massive amount of antibodies which have been formed in the victim's body, causing an anaphylactic shock which will kill him almost instantly, yet no one will ever suspect the real murderer.
  
  I tell this story to introduce my dilemma: I took a mixture of pork and beef insulin from age 14 to age 28, when I was switched to the GM insulins. Clearly I formed antibodies to the protein in the natural insulins I took for those 14 years. Being exposed to a foreign protein for a long period and then suddenly having no exposure for many years will generate a huge stock of antibodies in the patient. If I now switch back to insulin containing those same proteins, how do I know I won't be struck down instantly by a massive anapylactic shock, or, even if that doesn't happen, how do I know I won't suffer continuing, low-grade inflammatory response from the reintroduction of these antibody stimulants? In effect, I may be trapped on GM insulin, simply because of the danger now of switching.
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  1. 6/14/2008 9:11 PM Allie Beatty wrote:
     Hey Sanktpauli,
     
     Just a few questions about antibodies:
     
     How long does it take the body to develop antibodies?
     How long do such antibodies remain in the system if the antagonizing foreign protein is no longer present?
     
     For empirical effect – I began using pork NPH and Regular in Man / June 2007 after using rDNA human analogues for 22 years. When I was hospitalized in March / April 2008 – the hospital switched me back to analogues...first Humulin NPH and Humalog - then NPH and NovoLog. Neither combination worked - my glucose was erratic, at best. The section I got back home – I placed an order for my pork insulin and was back on it with 2 weeks. The choice is costly (at the moment) -- but the $300 I pay to import my insulin from Canada is worth the debt. Life was never like this on rDNA human analogues....EVER!
     
     Since I’m writing this response to you on June 14th (**updated June 16th**) it appears I experienced neither anaphylactic shock or any other life-threatening reaction. However I was only on pork insulin for 11 months before the (undesired) switch to rDNA. Like I said I was back on pork insulin within 2 weeks….
     
     Now that I’ve gone “pork”…. I’ll never go back!
     
     P.S. Your bee venom tid-bit is fascinating yet macabre -- LoL
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• 6/13/2008 4:56 PM Brent wrote:
  I cannot address the bee venom issue. But I can note my personal experience with animal vs. GM insulin. I used natural insulins (beef, pork & beef/pork) for more than 30 years. When the latest and greatest (NOT!) GM insulin appeared, I eventually succumbed to physician propaganda to “try it, you’ll like it.” (NOT!) When I first used Humulin, I had a ‘honeymoon’ period, where I experienced better release activity and desirous predictability. After about 2 weeks, the predictability and intensity of insulin curve became unknowable. Best attempts over a protracted period could not smooth out the treatment. So, I fell back on my store of natural insulin . . . and quickly returned to ‘normal’ if such term can be affixed to diabetes. NO ANAPHYLACTIC EVENTS! Several years later I tried again, using a pump and Humalog. Results were similar. . . honeymoon period, followed by yo-yoing bG’s. (Again, no anaphylactic events with return of rDNA insulin). Several weeks were endured before sacrificing pump therapy and returning to natural insulin. NO ANAPHYLACTIC EVENTS occurred when I returned to natural insulin. The entire process was repeated one more time. I would note that each rDNA ‘honeymoon’ period was briefer than the preceding one; there was no ‘honeymoon’ period when using natural insulin.
  
  One more incident—the reverse of the above--occurred last year. After using natural insulin for more than 10 years, I found myself in a dilemma. On vacation, I dropped & broke my vial of animal insulin. Unable to purchase natural insulin, I settled for a bottle of Humulin. I did not achieve ‘good’ results, but at least ‘some’ results. By restricting my diet, I managed to survive until I returned home. I did not have an anaphylactic reaction when I injected rDNA product into my body after a 10-year absence. I’ll be the first to acknowledge that my body and my experiences are unique to me.
  
  Your FEAR does NOT address the reality that some diabetics may have become diabetic because they were experiencing antibody response and attack on their Beta cells because of their own malformed human insulin. Why, then, wouldn’t all these diabetics have experienced anaphylaxis and death when switched from natural insulins to today’s malformed yet supposedly HUMAN insulin?
  
  If you are FEARFUL of reintroducing natural insulin into your body. why would you even consider changing? (Keep doing what you’ve been doing; but expecting ‘different’ results is the very definition of insanity.) Do you write here to expose your real concerns and fears? Do you seek to play devil’s advocate for those who may not have considered unintended consequences? Do you hypothesize because you have a vested interest in maintaining the status quo? Are you rewarded when insulin manufacturers and diabusinesses profit by continued use of their products? If your bee-sting analogy leaves you paralyzed with fear, wouldn’t some kind of immunologic testing provide a reliable guide for decision-making?
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  1. 6/13/2008 10:10 PM Sanktpauli wrote:
     No, I'm not posting as a Devil's Advocate, but I am actually considering switching back to natural insulins. I have noticed a number of negative responses to insulin which have only developed in the years since I have been on GM insulin, though I can't be sure that these do not simply reflect changes in my physiology and progression of the disease rather than the effect of the different insulin. But what I have noticed on GM insulin is 1) control is more difficult; 2) the lag time between injecting insulin and getting the desired effect from it is increased; 3) hypoglycemic episodes last longer, are less acute, and manifest as tiredness rather than agitation; and 4) any use of insulin to reduce the current level of blood sugar, whether that involves reducing it from 10 to 7 (convert SI to US units by multiplying by 18) or from 7 to 4 produces sleepiness.
     
     Some of these symptoms could be accounted for by decline in adrenal function, which is often found in long-term diabetics, especially those who have exhausted their adrenal capacity by repeated hypoglycemic episodes. But still, I am interested to see if returning to animal insulins may bring an improvement. Obviously I would try it with a small dose while armed with my anaphylactic shock injection kit. I might even make the first injections in the waiting room of a hospital emergency ward with a big sign hanging around my neck explaining what I have just done, just for added insurance.
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• 6/14/2008 1:57 PM BetterCell wrote:
  Sanktpauli.....
  You have excellent awareness of your body responses which is admirable.
  My experiences with GM Insulin vs Animal derived Insulin is that I no longer have awareness of Hypoglycemia until either I am passed out and then re-awaken 2 hrs. later, or in some incidences
  just the moment before of "going under." This may of course be related to the longevity of the Disease with accompanying loss of Adrenal Function and the
  decrease in Norepinepherine and epinephrine levels, this might have nothing to do with the *Type* of Insulin I am using(Animal-derived or GM).
  Are you actually planning to sit in an ER to test your responses to Natural Insulin as well as the wearing of a sign around your neck? lol
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• 6/14/2008 6:18 PM Brent wrote:
  Sanktpauli/BetterCell—
  
  I do believe the insulin cartel would be happy for all diabetics—new, experienced and older diabetics—to believe that their insulin is NOT responsible for the symptomologies you describe. In fact, in a court of law, where a driver with serious hypoglycemia unawareness had caused death to another driver, the prosecution was able to show the judge (in this case, an appeals court justice) that the driver was NOT under the influence of GM insulin. Thus, he remains in jail, forced to take rDNA human insulin—which is all that is available for the U.S. diabetic prison population. Is that a bit of judicial irony? If GM insulin was the underlying killer of the other driver, then perhaps the diabetic driver should also be killed by GM insulin . . . that sounds ‘fair’, doesn’t it?
  
  Sanktpauli, I appreciate your concerns and hypotheses regarding antibody response. Having made switches several times on the advice of my doctor—for periods of one to six months—any effects I’ve experienced would require a lawyer smarter than those Floridians I’ve seen thus far to place the blame where it belongs. I am more worried about the damage done to my endocrine system by repeated and unexpected hypoglycemic events; longer than normal periods of hyperglycemia in any given pharmacokinetic period; and the possible UNKNOWN consequences regarding Beta cell damage. Then, of course, there is a lingering suspicion that I DID have antibody/immunologic response to rDNA insulin; the inflammatory response probably caused further damage to my immune system and liver.
  
  My question to both of you would be: Why would any sane medical doctor—or patient—want to convert a patient from almost perfect bG management to something newer and more expensive with so many unanswered questions. During the 1980s and early 1990s, I was able to take a split dose of beef Ultralente (7U a.m./7& before bed). I could eat, or not eat, and stay within normal bG-levels and balance any meals with a bolus of Iletin II pure pork. I had enough ‘freedom’ that if I got serious exercise, all I had to do was eat a few more carbs to stay within normal range. As you know, you and I both sacrificed A1c’s in the mid 5 range in order to try this new s*&t they call insulin. How long are we going to continue to be ‘sheeple,’ remaining silent and taking what is offered. I believe the insulin cartel is counting on this silence, and at the same time counting . . . and counting . . . and counting their profits.
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  1. 6/15/2008 12:54 PM Sanktpauli wrote:
     The response of the law to diabetic hypoglycemia has always been absurd. (See, for example, the English case of R. v. Quick.) The usual approach has been that anything the patient does wrong as a result of his confusion in a hypoglycemic state is his fault, because he is deemed responsible since he took the insulin that caused it. (As though he had a choice not to!) But anything the patient does resulting from the confusion of a hyperglycemic state is not his fault, because the hyperglycemia is due to the action of the disease, not the patient, and so is outside his control. The law does not seem to understand the simple point that for the diabetic, insulin and diabetes are both part of the disease.
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• 6/14/2008 7:01 PM BetterCell wrote:
  Brent.......
  I remember that time in history very clearly when a massive marketing campaign was developed by Lilly, Novo Nordisk, and Sanofi Eventis to push these new GM Insulins to the ADA, Primary Care Physicians and Endocrinologists.
  These were suppose to be an improvement over animal-derived Insulin because they would be less contaminated, and work faster for the patient using them.
  Also around the same time there was speculation that animal sources would not be plentiful enough to supply needed Insulin for an increasing population with Diabetes. That plus the Moslem ban against pork derived products would then make everyone *a happy camper.*
  I, also did very well on my Utralente as a basal and Reg Pork-derived Insulin to cover carbs and Hyperglycemia. I did not have "Hypoglycemia Unawareness" at that time. But again, was this due to the type of Insulin I was using or was it due to not having Longevity related Complications?(Hypoglycemia Unawareness).
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• 6/15/2008 7:11 AM Melody wrote:
  Amazingly, the application for approval of rDNA human insulin does not mention the phrase 'hypoglycemia unawareness'.
  
  The trials that formed the base for the submission did mention hypoglycemia--and it appears the researchers worked diligently to prevent such episodes.
  
  Two protocols formed the basis for efficacy and safety. Protocol 3 had 108 diabetic patients of any age who had never received insulin. Protocol 6 had 121 IDDT patients of any age who had been on animal insulin.
  
  Protocol 3 had 38 Type 1 patients: 24 reported hypoglycemia during the 2nd month of therapy; hypoglycemia was reported by 15 patients during the 6th month.
  
  Of the 63 Type 2 patients, Hypoglycemia was reported by 32 patients during the 2nd month and by 25 patients during the 6th month
  
  Patients in Protocol 6 DID NOT RECORD hypoglycemic or hyperglycemic symptoms.
  
  The extremely small size of the study instrumental in gaining approval for such a widespread and growing population is astonishing.
  
  Hypo unawareness IS mentioned in literature that was presented to the EMEA. Dr. Arthur Teuscher (in Switzerland) did his own study of hypo unawareness as he began witnessing the phenomenon. His observations and writings are ignored in the U.S.
  
  Hypo-unawareness was RECOGNIZED in the 1970s--BEFORE we became uninformed guinea pigs for rDNA insulin. This was noted when Novo chemically created human insulin by exchanging amino acids, creating human insulin from pork insulin. Tattersall and others in Europe were extremely concerned about patient safety when they recognized this dangerous 'side effect' of human insulin.
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