2.The Bellagio report on GM insulin
3.The Myth of 'Human' Insulin
1.Letters to the South Gippsland Sentinel Times, Australia
GM insulin's side effects
2 Sept 2008
Both Wilma Western and Jeff Bidstrup (Aug 12) cite the use of genetic modification in some medical treatments as evidence for the safety of GM food. GM insulin is touted as the best example of safety and success in this area. However, my experience and that of many other insulin injection dependent diabetics is very different.
While taking GM or "human" insulin, my blood sugar control was poor. My blood test results were erratic and often differed from what I expected.
My hba1c results, which is a measure of longer-term blood sugar control, confirmed this.
However, after discovering that I was using GM insulin and that natural animal insulin was available, I decided to change.
As a result my blood sugar control improved immediately and substantially, as verified by my hba1c.
Even more surprising was the immediate 15-20 percent reduction in my daily insulin requirements with no change in diet, exercise or frequency and timing of injections!
Looking back, not long after I started on GM insulin I suddenly developed Crohn's disease. I didn't see a connection at the time.
However, since using natural insulin, my Crohn's has been in remission and without taking medication for it.
Also, I am currently taking an unrelated medication that, when previously taken whilst on GM insulin, always caused my Crohn's to flare up.
All this has made me question whether GM insulin contributed to, if not caused, my Crohn's.
There are many other reported negative effects from GM insulin. The most common being loss of hypoglycaemic warnings, leading to coma and death in some cases.
These important hypo warnings, which are a natural bodily signal that blood glucose levels have dropped too low, often re-appear when a diabetic starts using animal insulin.
Other adverse effects include severe tiredness, substantial weight gain, constantly feeling unwell, memory loss or confusion, erratic blood sugars, constantly sleeping, mood changes and joint pain.
It's a shame that most diabetics are not fully informed of their choices and told that there is a natural animal insulin alternative.
The other main medical treatment that now commonly contains GMOs is vaccines. But at the same time the rate and severity of adverse reactions to the newer vaccines is higher, such as we are currently seeing with Gardasil [HPV/cervical cancer vaccine]”¦
[GM Watch comment: The Gardasil vaccine, which has been heavily promoted for use on young schoolgirls on prime time TV in the UK, most recently by the journalist Jane Moore, is indeed genetically engineered though of course, this was not mentioned in any of the promotionals: http://biotech.about.com/b/2008/09/03/gardasil-safety-of-genetically-engineered-hpv-vaccine-still-in-question.htm ]
Life-changing insulin switch16 Sept 2008
To the writer, of “GM insulin’s side effects”, I cannot thank you enough for your informative letter. I am a type 1 diabetic who has been as such for my entire life. During the past 20 years I have been a user of GM human insulin after using pig and beef insulin throughout my childhood.
I was automatically put onto human insulin as it came onto the market believing it was the next best thing and the greatest treatment available. I never once questioned it ”¦ Since reading your letter and then researching the topic on the net, I was overwhelmed by the sudden awakening and realization that I have suffered over the past 20 years with an array of undiagnosed and bizarre daily symptoms and most probably unnecessarily.
I read page after page in a diabetic forum of other people's experiences with using this insulin. My problems are similar, if not identical, as with your list of side effects.
The unbelieving looks from doctors who have sent me away making me think that perhaps I needed Prozac are also a well documented scenario.
Only a few weeks ago I decided to give the health chase another go due to a strong sense of my ticking time bomb. After having every blood test available and then being told once again “your bloods are fantastic” I left and burst into tears for once again not finding the reasons for my failing health and my dismal daily sense of wellbeing”¦
My mental confusion at the worst was so bad I was told I probably had a brain tumour. I have had scans, MRIs, and been to see neurologists over and over again with no answers. I was given varied guessing explanations of perhaps you have epilepsy and given a cocktail of drugs that might help. It has never been suggested that perhaps my GM insulin was a problem for me”¦.
Over the years I have been diagnosed with chronic fatigue, fibromyalgia, and many other problems that didn't ever show up by any diagnostic method. With hypo warnings being replaced with nausea, feeling like my sugars are high when they are in fact low, memory loss so severe I don’t know if I have just done my injection or just thought about it, speech and conversation problems, fatigue, lethargy, migraines, mood swings, depression, sensitivities, night sweats, fevers, being off balance, faint, allergy type facial swelling, waking every morning ailing, body and joint pain, and living in a clouded state, I had succumb [sic] to the fact that this was simply my lot.
I thought perhaps I was just unlucky!
With reading your letter and then researching your claims I decided with hope to go back on bovine [beef] insulin”¦ Within 12 hours of using the beef insulin I became more agile, I slept on a cloud for the first time in 20 years, and my body aches and pains have slowly started to diminish. My daily facial swelling which was so bad I couldn’t leave the house and the pitted oedema in my legs has all but gone.
My neurological issues are still with me. With time I hope that passes, but who knows what permanent damage I am now left with”¦ I now grieve for my lost 20 years that could’ve been so much better for me and for my family.
Your letter was timely as I was about to take on an insulin pump of GM insulin as a last resort. I hate to think where that would have led me.
I hope this letter alerts other insulin-dependent diabetics and helps them to question their health too. I also hope this alerts the medical profession into considering the side effects of GM insulin when you are puzzling over the symptoms of your next type 1 diabetic patient.
As with GM food, there appears to be no long term knowledge of the effects of GM drugs on humans. The mind boggles to think that perhaps insulin-dependent diabetics of my era have been used as guinea pigs while the pharmaceutical companies have rolled in their wealth and enjoyed their good health.
Name and address withheld
2.The Bellagio report on GM insulin (1996)
In response to the proposed removal of animal insulin from the market in the next few years, the Bellagio Group, an international professional group sponsored by the Rockefeller Foundation in New York, gathered in Bellagio Italy on April 8 to discuss what actions should be taken. The result is this document which they have issued to the World Health Organization and other public health agencies worldwide. The report is a set of guidelines for the use and value of animal insulin.
Bellagio Report 1996
The welfare of people with diabetes depends on their active participation in their care. To achieve this, the patient must have information about benefits, risks and alternatives concerning his treatment. The patient must also have the appropriate facilities available to make a free choice regarding what type of insulin to use.
New research has made possible an overall understanding concerning differences in warning symptoms of hypoglycemia when using genetically produced human insulin and natural animal insulin.
The debate on these differences has continued since the introduction of treatment with human insulin and, unfortunately, very often the patients' experiences have been classed as "only anecdotal" and of little value.
Evidence supporting these experiences demonstrates neurophysiological differences during hypoglycemia in human and animal insulins.
Research has already demonstrated that human insulin has no clinical advantage for patients and that it has a faster absorption and consequently a shorter duration of action, so accounting for the greater fluctuations in blood-glucose levels. However, it has been the general view that because of its exact similarity to endogenous insulin, human insulin should be the insulin of choice for all.
With this in mind, we have put forth these five points:
I. that this latest information be relayed to those living with type I diabetes. This will enable those experiencing impaired or reduced warning symptoms of hypoglycemia or diminished feelings of well-being and safety, to re-examine their choice of human or animal insulin. This choice will then be based on both scientific evidence and the reported experiences of patients.
II. that this information be reported to government health departments, WHO, IDF, Diabetes Associations, physicians and all diabetes health care professionals worldwide.
III. that when insulin is needed, animal insulin should be considered as first choice treatment for all those where hypoglycemia may be of special concern. This may include the following:
2. the elderly
3. those reporting severe and/or frequent hypoglycemia
4. those with severe cardiovascular disease or long-term complications
5. those who do not have access to frequent blood-glucose monitoring, e.g., in developing countries.
IV. (i) that animal insulin remain available in all countries which presently have that facility.
(ii) that animal insulin is re-introduced into countries in which it is no longer available through the normal prescribing mechanism.
(iii) that animal insulin for insulin pens become available again to provide equal choice for patients and physicians.
V. that in future, greater recognition be given to the value of patient experiences in relation to adverse drug reactions.
3.The Myth of Human Insulin
by Gisela Sonnenburg
Die Welt (Germany), Feb 3 2006
Dr Ernst von Kriegstein of the Paul-Gerhard-Trust in Wittenberg stated that there were problems during the initial studies of 'human' insulin in the USA because some patients had to discontinue the trials due to 'incompatiblity'. Despite this, Novo Nordisk and Eli Lilly went ahead and doctors who converted patients on to human insulin were paid DM100 per patient.
Complaints from patients were not heeded. "I was not told at the outset what I was getting", said Armin Schenk. Like Schenk, hundreds of patients in Germany suffered; they lost the early warning signals of an impending hypo and some people had an allergic reaction showing up as anaphylactic shock and nausea.
But human insulin was promoted as the wonder drug: "Incompatibility of human insulin is impossible, as its structure is identical with that found in the human body," stated Markus Leyck Dieken, head of Novo Nordisk in Germany. Many doctors reinforced the myth suggesting that allergies were due to the additives, like zinc. Dr Nikolas Tacke, a lobbyist in Berlin, stated that "products made by gene technologies are the safest known."
Such theories are not supported by recent findings of the Institute for Quality and Efficacy in Healthcare (IQWiG) which relate to insulin analogues. Head of IQWiG, Prof. Peter Sawicki, stated: "Up to now we have only evaluated short-acting insulin analogues in patients with Type II diabetes. For these patients we can state, with certainty, that they bring no real advantages." Even the predicted ease of use was not confirmed. "It is a fairy story that insulin analogues offer an improvement to one's eating habits or lifestyle."
However, it is no fairy story that "experiments with animals and cell cultures suggest at least the pathophysiological possibility of carcinogenicity." In short: insulin analogues carry the risk of cancer. But this is not new; as early as 1992 all studies in patients of an analogue from Novo Nordisk were discontinued, as the result of the development of breast cancer in rats.
Professor Chantelau warned: "Many cancers have a long period of latency. That for breast cancer can require 15 years. The industry has conducted many patient studies with human insulin and analogues - but no long-term studies into the possibility of cancer." That was also the warning from the IQWiG. Chantelau's main criticism of gene-modified products is that "normally insulin is produced by specialised cells. It is a highly complex synthesis." The biotech production is not identical to that of nature: bacteria such as Escherichia coli or certain yeasts are gene-modified so that they produce the molecules, or part molecules, of human insulin. Whether or not the folding of the amino acids is identical to that of human cells is not known - only the chemical formula is identical. How incompatibilities result for the patient has not been researched.
Referring to the refusal of many insurance companies to pay for imported pork insulin, Prof. Konrad Wink from the Pharmaceuticals Commission of the German Medical Association (AKdA) said "But that can be no reason to force a patient to switch to a product that may not be tolerated. It should never have come to this". The AKdA will recommend to the insurers that they should meet the costs of porcine insulin.