EXTRACTS FROM CONQUEST - The Journal of Diabetes Australia

BEEF CHANGE 'DREADFUL'
CONQUEST - Autumn 1999

I am writing to inform you of my husband's position; he had been a diabetic for 25 years using Isotard MC [isophane beef insulin].
Recently his doctor changed him to a human insulin with dreadful results.   He was just not the same person; he knew this and so did I.   He was returned to Isotard but told he would eventually have to change as Isotard would be removed.
We rang the company supplying Isotard to be told that at this stage they did not have a date for the cessation of production of this insulin.   Evidently even when this date is decided there would be about a year's supply still in stock.
Therefore because of the difference in my husband's health and well-being we are prepared to accept that Isotard is available for the present and take each day as it comes.
However, I am anxious to know just what will happen if/when it is removed and am not prepared to accept this as a fact.   What can we do to convince the authorities of the necessity of retaining porcine and bovine insulins.   How can we obtain the correct information regarding current supplies of these insulins?
These questions need answers and I am not prepared to accept half answers.   We should be uniting to form an organised body able to converse with those who make the decisions that so radically affect our lives.

Mrs Joan Sullivan
Launceston TAS

Novo Nordisk did announce withdrawal of their range of beef insulins effective from August 1999 but Hypurin Isophane and Neutral will remain available.

CONTROVERSY CORNER

Jenny Hirst was awarded the prize for her article in Diabetes Conquest, Winter 1998 edition.
'Insulin supplies monopoly threatens freedom of choice'
I am aware that natural porcine insulin has been unavailable in Australia for several years and I am also aware that it was withdrawn rapidly so forcing people to change to genetically produced so-called 'human' insulin.
In the UK we had the advantage of porcine insulin remaining on the market but nevertheless 84% of people using insulin were changed to 'human' insulin by the late 1980s, often without discussion with them or with the incorrect information that "animal insulins were no longer available".
Our Trust formed in 1994 because it was clear that for some people 'human' insulin caused adverse effects and yet in spite of complaints to the regulatory authorities and the British Diabetic Association, no large scale trials comparing 'human' and animal insulins were ever carried out, no formal post marketing surveillance was carried out and patients were refused their right to change from 'human' to animal insulin and often told that they were imagining the problems.
Our Trust aims to ensure that animal insulins remain on the market for those who need or prefer them but the then only supplier of porcine insulins in the UK have only guaranteed supplies until "into the next millennium".
The monopoly situation of only having one supplier meant that the pharmaceutical industry controlled the prescribing of insulin, not the doctors, nor did the patients have any freedom of choice.
In 1997 a small British company, CP Pharmaceuticals (now Wockhardt), expanded their range of insulins from just bovine to bovine and porcine making both available in cartridges for injection pens.
We are grateful that they recognised the need of the 50,000 people in the UK still taking animal insulin, but we cannot afford to be too complacent.
'Human' insulin in the UK is still prescribed almost automatically which means that the problems which some people have are being ignored and the newly diagnosed may be suffering from them without realising that their symptoms could be relieved by a change to natural animal insulins.   We know from the people with diabetes that these problems do not just affect those who were originally on animal insulin, they are also affecting the newly diagnosed who have only ever used synthetic 'human' insulin.
These problems fit into clearly defined categories and the results of our questionnaire to our members showed the same problems demonstrated in a prepared report by the BDA, which was never published.   The first 100 people to contact the Insulin Dependent Diabetes Trust gave us the following data: There are other symptoms that family carers noted such as behavioural changes, mood swings and 'not the same person'.
IDDT has contacts in various countries where people with diabetes are complaining of similar symptoms.   This clearly is a global problem which remains unacknowledged by the manufacturers, the medical profession and the regulatory authorities all of whom maintain the same stance that there is no scientific evidence to support our claims.
However, we are not all imagining these problems and there is no gain for us in doing so.   The reality is that there never was any evidence to show that 'human' insulin has any clinical benefits over animal insulins.   There is still no evidence and 'human' insulin has not turned out to be cheaper as was originally claimed.
The change to 'human' insulin was based on assumptions and not on evidence and the present use of it as the treatment for diabetes is still based on assumption and not evidence.
While people continue to have problems we shall continue to seek recognition of them and remind those who believe the 'no scientific evidence' theory that equally there is no scientific evidence to disprove that a significant minority of people do have problems with 'human' insulin which largely disappear with a change to either porcine or bovine insulin.
We have concerns for countries such as yours where those who need animal insulin have no choice and we would like to hear from anyone who has the symptoms I have described.

Contact me, Jenny Hirst at:
Mail:IDDT, PO Box 294, Northampton NN1-4XS, England.
Email:enquiries@iddtinternational.org
Tel:+44 (0) 1604 622837
Fax:+44 (0) 640 636838
We would like to remind you that Wockhardt do supply bovine insulins to Australia and these have a much smoother peak of action than 'human' insulin and may be an alternative worth discussing with your doctor.

Jenny Hirst
Co-Chairman of IDDT

EDITOR'S COMMENT: Wockhardt are represented by Aspen Pharmacare in Australia and we are advised that both isophane and neutral bovine insulins are available in Australia. Both are listed on the Pharmaceutical Benefits Scheme and your doctor can write a prescription for them.

Side effects of insulin injections revealed

By JULIE ROBOTHAM Medical Writer, and agencies
Wednesday, 10 Mar 1999
From section: News And Features
Publication: Sydney Morning Herald

Up to 40,000 Australian diabetics may unwittingly be suffering adverse side effects from taking genetically engineered synthetic insulin, suggests British research completed six years ago which has just been revealed.
But the availability of animal-derived alternatives, which doctors agree suit some patients better, is about to be further limited by the withdrawal of the main brand of cattle-derived "beef" insulin from the local market.   Novo Nordisk will withdraw from the market in July, citing commercial reasons.
"Pork" insulin was withdrawn in 1990, though the firm makes it available to some people on "compassionate grounds".
The UK research, commissioned by the British Diabetics Association, has found up to 10 per cent of diabetes patients may suffer side effects - the most serious of which is a dangerous loss of the ability to recognise they are about to lose consciousness - as a result of taking synthetic "human" insulin.   This has almost completely superseded insulins derived from pigs or cows.   The research was based on studies of 3,000 diabetics after they switched to human insulin.
Injected daily, insulin replaces a hormone, usually produced by the pancreas, for people whose bodies do not manufacture it naturally.   Without it, diabetes is potentially fatal.
The manager of educational services for the NSW branch of Diabetes Australia, Ms Bernadette Lowther, said:
"The majority of people have no problems with the transfer to human insulin.   For a small minority we hear reports that the quality of life was impaired . . ."
Supply changes for beef insulin, which is understood to be used by about 3,000 of Australia's more than 400,000 diagnosed diabetics, would affect the elderly the most, Ms Lowther said.   Several concerned doctors had contacted the organisation.
"This is a significant issue for older people who have controlled their diabetes very well on one injection a day,"
she said.   The tendency was for people to need to inject more frequently - up to four times a day - when they switched to human insulin.
The medical director of Novo Nordisk, Dr John Miller, said there was no evidence that either form of insulin was superior to the other.   But human insulin was cheaper and safer to produce as it was guaranteed free of animal viruses.
The professor of diabetes at Melbourne's Monash University, Professor Paul Zimmet, said the number of people who genuinely needed animal insulin was "minuscule".
However, switching drugs could cause problems because the volume of synthetic insulin required was usually lower, which not all doctors understood.
Mr Ron Walker, 67, of Allawah, says the two years he spent on human insulin were "the most disastrous period of my life".   He used the synthetic drug around 1990 when pork insulin was first withdrawn.   He lost consciousness several times without warning and eventually insisted on using beef insulin.
Beef insulin will continue to be supplied by Rhone-Poulenc Rorer, which had also planned to leave the market but reversed the decision after renegotiating its price.


In the English newspaper, The Guardian, October 3, 1999 is an article that has been summarized as follows:

Diabetics not told of Synthetic Insulin Risk

Evidence that thousands of diabetics may have suffered a deterioration in their health from synthetic insulin has been withheld by the British Diabetics Association.   A report, commissioned by the association and completed six years ago, highlights the dangers faced by about 10% of the 150,000 diabetics who had been switched from the traditional animal-derived insulin to the synthetic variety.   Some of those adversely affected began to go into comas known as hypoglycaemic episodes.   Some suffered severe injuries, a few crashed their cars and others believed they would have died had they not been rescued as they lay unconscious.   The association did not publish the report because it claims it was too alarmist.   The manufacturers of synthetic insulin, Novo Nordisk and Eli Lilly, deny it has negative effects.   But diabetes expert Dr Matthew Kiln, a south London GP who was a member of the committee set up by the BDA to look at the side-effects, said the association had failed in its duty to protect and represent the interests of diabetics by not publishing the committee's findings in full.   He added that doctors who understand the issue have been quietly switching some patients back to animal insulin, but thousands of others are suffering from lack of choice."


Hypoglycaemia in insulin dependent diabetics attending an outpatients' clinic.

Ward CM, Stewart AW, Cutfield RG
North Shore Hospital, Auckland
N Z Medical Journal 1990, Jul 25; 103(894):339-41
One hundred and fifty-eight patients with insulin dependent diabetes mellitus attending two Auckland outpatient clinics answered a questionnaire about hypoglycaemia.   Almost all (98%) had experienced hypoglycaemic episodes and for 30% these were a major problem.   Seventy-seven percent reported nocturnal hypoglycaemia, 39% of whom required external assistance during episodes.
Forty-three percent had experienced coma, or convulsions during hypoglycaemia and a small group, 7%, had recurrent severe episodes.   Twenty percent carried no diabetic identification and 13% did not routinely carry a glucose supply.   Only 38% of patients kept glucagon at home.   Forty percent of patients driving vehicles had experienced hypoglycaemia while driving and 13% reported traffic accidents attributed to hypoglycaemia.   Hypoglycaemia is a major problem for many patients taking insulin.   Improved education, wider availability of glucagon and more liberal glycaemic control of patients with problematic hypoglycaemia may be advisable.

Perhaps natural animal insulin would be the answer?
(Ian Kershaw)


LOCAL LINKS
  1. Introduction to IDDT-Australia
  2. IDDT Australia - Agenda
  3. IDDT Australia - Latest News 14 March 2007
  4. THE GM INJECTION - Special report from Jo-Ann Goodwin (UK Daily Mail August 2002)
  5. IDDT Australia - Australian Government Indifference!
  6. Availability of animal insulins
  7. Obtaining natural insulins in Australia - updated 14 March 2007
  8. Press cuttings & extracts from The Diabetes Australia magazine CONQUEST THIS PAGE
  9. Event Reports (dangers highlighted)
  10. Patient experiences
  11. Action Corner
  12. Putting the situation into perspective
  13. Introducing IDDT - PDF file
  14. Diabetes Internet Resources

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3 July 2007