The
Society For Diabetic RightsMany diabetics are not aware that Eli Lilly is withdrawing Iletin II NPH and Iletin II Regular. The company also announced it will be withdrawing Humulin U and Humulin L.
Lilly and Health Canada have said all efforts are being made to provide alternatives if the supply of the two Iletin brands runs out before another manufacturer steps in to the picture. While Health Canada says that Wockhardt, a UK company (formerly CP Pharmaceuticals), has applied for permission to sell pork insulin in this country, Health Canada cannot guarantee that this approval will be provided before Lilly's supply runs out.
Since 1994, Novo Nordisk and Eli Lilly have withdrawn more than 30 types of insulin (most but not all of them animal-sourced), none of them, as far as we know, for clinical reasons. Along with Aventis the two companies have also introduced different insulin analogues, all of them at steeply higher prices.
In 1995, for example, many of us were paying between $10 and $11 per 10ml vial of beef/pork insulin. When these were withdrawn people were forced to pay higher prices for Humulin or Novolin insulin. If these didn't work - and they didn't for quite a few people - they were usually switched to Humalog or Novorapid at up to $30 per 10ml vial, plus $5000 for an insulin pump and another $1000-$1200 annually for pump supplies.
The latest insulin analogue (Aventis' Lantus) costs between $65 and $75 per 10ml vial depending on where one lives in Canada.
Not a single new insulin has offered any significant clinical advantages over pre-existing animal types, most of which have disappeared, yet the prices have increased steeply. There also are higher risks associated with genetically modified insulins for some people. According to Health Canada representatives, "The current science knowledge does not really enable us to understand why the synthetic insulins or the human insulins do not work as well for some people as do the animal insulins, but clearly that is the case". (Julia Hill, Feburary 3, 2003, Standing Committee on Health)
The manufacturers (Eli Lilly, Novo Nordisk, Aventis) hope to persuade insulin users and their physicians that the newer analogues provide advantages not offered by the older genetically modified human insulins. However, the European Agency for the Evaluation of Medicinal Products, known as EMEA, and the prestigious Cochrane Group have cautioned that insulin analogues have been inadequately tested, have shown no benefits over existing GM insulins and may be linked to increased risk of cancer, retinopathy and in some patients a more rapid progression of diabetes-related complications.
Although the cancer risk may be small, most newly-diagnosed Type 1 diabetics are children and there is nothing known about the long-term effects who will sustain the longest exposure to insulin analogues. At a minimum more studies are needed on insulin analogues before they become the main type of insulin product available to insulin-dependent diabetics. At the end of this email is more information about the possible link between insulin analogues and cancer.
Novo Nordisk continues to supply pork insulins to the European market but there are concerns that the company may planning to withdraw this needed medicine as well. In the UK there are roughly 30,000 people who use beef and/or pork insulin. This is only because of the vigorous campaign by animal insulin users, their supporters and advocacy groups (ie., the IDDT) to raise public awareness and bring the appropriate pressure to bear on the government and producers.
Below are some links with more information:
http://www.hc-sc.gc.ca/hpfb-dgpsa/bgtd-dpbtg/qa_insulin_july_2005_e.html
www.emea.eu.int/pdfs/human/swp/037201en.pdf
The Insulin Dependent Diabetes Trust also has very good background information on this issue at its website: http://www.iddtinternational.org/reviewsandreports/
Some other research on the topic:
Points to Consider Document on the Non-Clinical Assessment of the Carcinogenic Potential of Insulin Analogues
1.3 Causes for concern
Pre-clinical findings
The primary example is the AspB10-substituted human insulin analogue, which was found to induce mammary tumours in rats...[T]he mechanism(s) responsible for (this) remain to be clarified.
Siebenhofer A, Plank J, Berghold A, Narath M, Gfrerer R, Pieber TR. Short acting insulin analogues versus regular human insulin in patients with diabetes mellitus. The Cochrane Database of Systematic Reviews 2004, Issue 4. Art. No.: CD003287.pub3. DOI: 10.1002/14651858.CD003287.pub3.
http://www.cochrane.org/cochrane/revabstr/AB003287.htm
Structural homology of insulin analogues to insulin-like-growth-factor-I (IGF-I) has caused concern regarding the progression of diabetic late complications and potential mitogenic (induction of cell division) effects, especially with long-term use of insulin analogues. IGF-I may affect the progression of retinopathy (King 1985; Grant 1993) and certain modified insulin analogues have shown a carcinogenic effect in the mammary glands in female rats (Jorgensen 1992) or mitogenic potency in osteosarcoma cells (Kurtzhals 2000). Despite these potentially adverse properties of insulin analogues, only very limited data on long term safety are currently available, mainly because patients with clinically relevant microvascular complications have been excluded from most clinical studies.
The reviewers' comments in Cochrane's 2005 update to the above indicated some concern about the marketing tactics of insulin analogue manufacturers (Eli Lilly, Novo Nordisk, Aventis): "Our analysis suggests only a minor clinical benefit of short acting insulin analogues in the majority of diabetic patients treated with insulin. Until long term efficacy and safety data are available, we suggest a cautious response to the vigorous promotion of insulin analogues."
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For more information, send us an email at info@diabeticrights.ca Last Modified: ©2009
