THE TIMES - HEALTH
October 16, 1999 UK
WHEN INSULIN IS A CURSE, NOT A CURE

One in five diabetics react badly to human insulin, but doctors don't always listen.
Report by Veronique Mistiaen
In the early Eighties Amanda Sugarman switched from the animal insulin she had used since childhood to a genetically engineered "human" one.   The drug had been hailed as a breakthrough and for most patients, it was.   But for Amanda, the changeover marked the beginning of seven painful and distressing years.   Her experience, shared by thousands of diabetics, raises the question of what doctors should do when scientific evidence and patient's experiences appear to contradict one another.

"I never had any trouble during my years on animal insulin, but with the human one I felt I couldn't control my diabetes," says Amanda, a mother of two from Leeds.   Her blood glucose levels started to fluctuate wildly.   "When it drops you feel tired and nauseous," she says.   When it is high you become bad-tempered and lethargic - a bit like PMT, only twice as bad."

Like Amanda, more than 250,000 people in Britain have type 1 diabetes, necessitating daily injections of insulin to control blood glucose levels.   Until the early Eighties insulin was extracted from the pancreas of pigs and cattle. Then scientists introduced the insulin-producing human gene into bacteria or yeast to produce "human" insulin.

By the late Eighties it had become the most common form of treatment in the West and people who had diabetes newly diagnosed were automatically started on it.   It looked as if animal insulin would be phased out.   For about 80 per cent of diabetics the changeover was a success.   But for others the new drug caused problems.   Amanda found that she no longer experienced vital warning symptoms - sweating, shivering and fast heartbeat - to let her know that her blood glucose level had fallen so low that she was at risk of a hypoglycaemic coma.   "Many times at night I went into a coma and my husband had to inject me with glucose to get me out of it.   Without warning signs you lose your independence.   You have to rely upon family and friends to know what to do," she says.   Amanda complained to her doctor, but after changing her dose a few times he became impatient, as scientific studies show no difference between the two insulins, apart from a slightly faster action in the human one.

Yet unknown to her, about 3,000 people had written to the British Diabetic Association (BDA) describing similar problems, and many letters were accompanied by detailed records of blood-sugar levels.   Specialists commissioned by the BDA analysed a sample of nearly 400 letters and concluded that most did have problems with hypos and half experienced the loss of warning signals.   This sometimes resulted in accidents, injuries, loss of jobs and disruptive or aggressive behaviour.   One fifth of the surveyed patients managed to switch back to animal insulin and almost all reported a great improvement to their health.

The BDA commissioned a review of all clinical trials and other medical evidence to compare the side-effects of animal and human insulins.   The report, by the Nuffield Institute for Health in Leeds, completed this Spring, concluded that "human insulin doesn't increase the frequency or affect the symptoms of hypoglycaemia among the general population using insulin".   But it acknowledges that some people have had problems while using human insulin   The Government's Committee on Safety of Medicines came to a similar conclusion.

For some patients and doctors this chorus of "no evidence" is infuriating.   Matthew Kiln, a South London GP specialising in diabetes, says: "The medical establishment doesn't regard what patients say as a valid form of evidence, and that is ludicrous."   Medical studies, he says, are done "in hospitals with a highly selected group of people in a situation that doesn't reflect real life, so they may not pick up subtle differences".   He is also a diabetic and he tried human insulin.   "It was unbearable.   I had many hypos.   I kept passing out and my personality changed.   I became short tempered   But my doctor wouldn't listen."

In desperation, he co-founded the Insulin Dependent Diabetes Trust, a charity that campaigns for a patient's right to information and choice, and to ensure that animal insulin remains available for those who need it.

Many specialists who are not convinced that human insulin is to blame for the problems agree that patients should have a say in their treatment.   "With chronic diseases, when patients depend for their lives on medicine, they should be made comfortable with their treatment," says Stephanie Amiel, the Professor of Diabetic Medicine at Kings College Hospital, London.   "If two treatments are of equal safety and efficacy, they should be able to choose.   There is a danger of not looking at other issues that might be causing hypos."   She mentions a study where she and colleagues at Guy's Hospital were able to restore warning signals in patients on human insulin.

Other known causes for frequent hypos and loss of warnings include: lots of previous minor hypos, which impairs the ability to recognise the next one; timing of meals; increase in exercise or failure to evaluate when the resulting hypo will take place; and misjudging how much insulin is required.

Mark Airey, a senior research fellow at the Nuffield Institute, says that patients were initially given the same dosage and regimen as they had had on animal insulin.   But because human insulin acts a bit faster, the regimen needed readjusting.   It is also possible, however, that people who have been on animal insulin for a long time develop antibodies to it, and these slow down insulin action.   Longstanding diabetics also develop complications, including neuropathy (nerve damage), so they may not be able to feel the warning signals as well.

However, Dr Kiln believes it is not just people who had used animal insulin who have problems with human insulin.   Amanda's daughter, Donna, was put on human insulin at 7 when she had type 1 diabetes diagnosed.   She suffered the same wild fluctuations as her mother.   "They would call me from school because Donna was becoming violent.   She was having hypos, but she didn't know it."   When Donna took animal insulin, her symptoms disappeared.

In many countries, such as Australia, Canada, France and Sweden, animal insulin has been withdrawn.   In the UK at least one company, CP Pharmaceuticals, has pledged to keep producing animal insulin as long as people need it.   Meanwhile, pharmaceutical companies have already developed a new generation of human isulin (analogue insulin), that provides better control and helps diabetics in their juggling act.   The ideal treatment, says Mark Airey, would be an insulin that releases itself according to needs - a wristwatch-like glucose monitor that would constantly give your blood-glucose level and an insulin you could inhale instead of injecting.

Industry agrees with patients, but perhaps only when it suits them!
by Jenny Hirst
After nearly twenty years of use, it is widely accepted that synthetic 'human' insulin does produce adverse reactions in some people - the worst being deadly anaphylactic shock.   All drugs have adverse reactions for some people, so why should insulin be any different?   Even the pharmaceutical industry accepts this, but perhaps only when it suits them!

A submission of PhRMA, the US pharmaceutical trade and lobbying union, dated December 3rd 1999, referring to the recent changes in drug pricing policy in Australia says "The introduction of Therapeutic Group Premiums….does not recognise that some products are not interchangeable, and that individuals do not necessarily respond in an average or predictable way….."   This is in entire agreement with the views of IDDT - not all insulin species are interchangeable and some people do not respond in an average or predictable way to 'human' insulin.

If, indeed, the pharmaceutical industry really does believe this statement because it is not too happy about the changes in drug pricing in Australia, then one has to wonder why they have such difficulty in applying these beliefs to insulin!

VIAGRA - NOT FOR AUSTRALIA!!
by Jenny Hirst
According to a news item in the Lancet [April 1st 2000] the Federal Court of Australia rejected Pfizer's application to overturn the decision of the Pharmaceutical Benefits Advisory Committee to refuse to allow Viagra in the government's Benefits Scheme.
Inclusion in the Scheme would mean that Viagra would be supplied to the public at a substantially reduced cost because it would receive a government subsidy. The government estimated the cost would be US$123 million per year.
Pfizer alleged that because the Committee was made up entirely of medical and pharmaceutical experts it was not entitled to consider the cost to the government, only the potential medical benefit.   I rarely feel in agreement with the pharmaceutical industry but their point does seem reasonable and I have to wonder if their decision would have been the same if the Committee making the judgement did the unthinkable and included actual patients or consumers amongst its members!   One cannot help but think that they may well have a better understanding of the effects impotence can have on daily living - not just for the man with impotence but for his partner too and their relationship.
I wonder how they arrived at the figure of US$123 million and if the Committee have taken into account the needs of people especially vulnerable to impotence, men with diabetes.   A study published in the American Medical Journal [JAMA] has shown that Viagra improved erectile function in only 56% of men with diabetes for 12 years and had been impotent for an average of 5.6 years.   A Cochrane Review of impotence treatments has shown that Viagra is only successful in 46-64% of men with diabetes compared to 85% of non-diabetic men.
It would seem that there are no exceptions allowed and yet the cost for exceptional conditions particularly vulnerable to impotence such as diabetes, would not be large and the long term costs may not be as significant as originally thought.
Caverject, also a treatment for impotence is already available on the Scheme but it would be beneficial if people had an affordable option if this one does not work.   However, it appears that choice is only available to men with impotence if they can afford it!

Make a comment or Tell your story
Is there some comment you would like to make about the need for animal insulins.   Would you like to relate an experience you have had with "human" insulin and would like known (perhaps published on the web site).   Click the link below and tell your story. Please give your name and contact details.   These will not be published without your consent.

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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
9. Event Reports (dangers highlighted) THIS PAGE
10. Patient experiences
11. Action Corner
12. Putting the situation into perspective
13. Introducing IDDT - PDF file
14. Diabetes Internet Resources