You can view the current or previous issues of Diabetes Health online, in their entirety, anytime you want.
Click Here To View
Latest Diabetes Articles
Introduction This article was originally published in Balance, the magazine of the British Diabetes Association (BDA), and was written for a British audience.
The article concerns the problems people with diabetes have had when switching from animal-source insulin to human insulin, and covers the problem in great depth.
It's interesting to see how Britain has responded to the human vs. animal insulin controversy, as well as the withdrawal of beef insulin from the market. The BDA has organized an "Insulin Campaign" petitioning the insulin manufacturers to continue producing animal source insulin, and they have collected 140,000 signatures to date.
About 250,000 people in the UK treat their diabetes with insulin. Of these, approximately 80% are treated with human insulin. While human insulin is s uitable for the vast majority of people with insulin dependent diabetes, a small minority of people have experienced problems since its use became widespread in the late 1980's and prefer to be treated with animal insulin.
Although Novo Nordisk, the major supplier of insulin in this country, has stated that animal insulins they manufacture will remain in production at least until the turn of the century, there is no guarantee that they will remain available indefinitely. The British Diabetes Association (BDA) supports the views of people with diabetes who prefer to use animal insulins and for this reason launched the highly successful Insulin Campaign petition in April this year. This special Balance supplement takes an in depth look at the issues which surround the insulin debate.
What is insulin?
There are 38 types of insulin currently marketed by three companies in the UK, Novo Nordisk, Eli Lilly and CP Pharmaceuticals. These insulins differ in how they are prepared so as to regulate the rate at which they work in the body. Insulin today is very pure and allergic reaction is rare. Insulin is either extracted from animal pancreases (pigs and cows), or from bacteria or yeasts which have been genetically engineered to make human insulin-a fermentation process rather like making a huge yogurt! Human insulin does not come from human pancreases.
In 1980, when human insulin was first tested, there was great excitement about this new development. Although animal insulins had been a miraculous life-saver for people with IDDM, some concerns had been expressed about their continued availability. They were not identical to human insulin and so might cause antibodies. The supply of animal insulin was linked to the demand for meat (animal insulin is manufactured as a by-product of this process; animals are not slaughtered specifically to make insulin) so supply of insulin could not be regulated by the requirements of people with diabetes. Outbreaks of disease among animals might unexpectedly reduce the supply of the pancreases which was not unlimited in any case. An end to this uncertainty was greeted with enthusiasm by both health care professionals and people with diabetes alike. It was also commonly accepted that, as human insulin is identical in structure to the real thing, it should be better for use in treatment.
By the late 1980's, injections of human insulin had become the most common form of treatment for people with insulin dependent diabetes. Nowadays, the vast majority of people who are diagnosed with this type of diabetes will be started on human insulin treatment. It is now unusual to be started on animal insulin, although some people who had been using animal insulin for many years reported problems with human insulin treatments, such as losing their hypoglycemic warning symptoms and have changed back to animal insulin.
The BDA Insulin Debate
The history of the insulin debate in the U.K. has been going on since 1987, when the British Diabetes Association (BDA) first began receiving reports that people who had switched from animal to human insulin were noticing changes in their hypoglycemia warning signs.
By May, 1989, amid numerous queries from concerned people with diabetes, Dr. Bill Alexander, prepared the following position statement on behalf of the Professional Advisory Committee of the BDA:
"Such problems (loss of warning symptoms) have caused us great concern. We sometimes tend to consider hypoglycemia to be an inevitable but minor irritating consequence of insulin therapy. People with insulin treated diabetes would be right to criticize such a complacent view. Hypoglycemia, especially if severe or without warnings, can be most frightening and incapacitating and can threaten normal life and employment."
The BDA also stressed that nobody should ever have their insulin changed without a full explanation of the reasons for the change.
In August, 1989, the public eye was again turned to the insulin debate when Dr. Patrick Toseland at Guy's Hospital in London suggested that the unexplained death of a young woman with diabetes was related to her recent switch to human insulin.
Following this report, the BDA looked at mortality rates for the 1980's, when the trend towards human insulin began, and found no changes in the mortality rates of people with type I diabetes. After these findings, the BDA stated, "The BDA is very concerned about the recent reports... We would stress that there is no evidence that the death was caused by hypoglycemia or that there is any connection with human insulin."
The unsettling fact remained that there were some unexplained deaths in the statistics, and for this reason the BDA is currently sponsoring a study led by Dr. A. Swerdlow of the London School of Hygiene and Tropical Medicine which will examine the unexpected deaths of relatively young people with diabetes. This is the largest study in the world to examine the associations of the deaths, including type of insulin therapy.
The BDA also set up a series of groups, including the Human Insulin Working Group and the Loss of Warnings (LOW) Task Force. These groups were formed to research and promote awareness of the problems associated with losing warning signs.
The two groups drafted a leaflet, titled People With Diabetes and Changes in Hypo Warnings. The groups also worked on a campaign to get animal insulin for use in pen injectors.
In April, 1994, as rumors began to circulate that animal insulin might be phased out all together, the BDA stepped up its campaign to ensure the availability of animal insulin.
To date, the BDA has collected more than 140,000 signatures.
Are we listening to patients?
'The management of a complex chronic condition requires the involvement and co-operation of the person with the condition, the doctor and the whole health care team. The relationship between them is crucial to successful management and requires mutual understanding and respect for each other's different spheres of knowledge. Both the health care professional's technical knowledge and experience of the condition in general, and the patient's experiential knowledge of her or his own bodily reactions, are needed.' Are we listening to patients? Reflections on the human insulin controversy-by Natasha Posner
Chronicle of Experience
During the period 1989-1992, the BDA received letters from 384 people with diabetes chronicling their experiences of changing from animal insulin to human insulin. Natasha Posner was asked by the LOW Task Force in 1993 to analyze the contents of these letters, treating them as an authentic, relevant source of data on the effects of the changeover from the view point of people living with diabetes, both patient and carer. Since many people had written in response to a request to hear from people who had experienced and were particularly concerned that their hypo warning symptoms had changed or vanished altogether resulting in a reduced sense of security and quality of life.
The range of symptoms that these correspondents complained of, and their reports of related consequences, were recorded under four headings: problems with hypoglycemia, deterioration in diabetic control, deterioration in general health and deterioration in the quality of life.
The majority of letters (77%) mentioned problems with hypoglycemia after changing to human insulin. Nearly half-48% experienced loss of warning symptoms of an approaching hypo. 27% complained that hypoglycemic episodes were more frequent and 18% that they were more severe. A deterioration in diabetes following the change to human insulin was reported by 28%. The report commented that: The problems with control resulted from blood sugar levels which correspondents found varied rapidly and, apparently, inexplicably, and from a tendency to hypoglycemia which they could not predict or easily counteract. Together, these problems could seriously undermine a person's confidence that they were in control of their diabetes and able to lead a normal life. Many felt that their diabetes was unstable and out of control for the first time in their, usually long, diabetic history. (Ninety percent of those correspondents who mentioned the length of time since they had been diagnosed, have had diabetes for over ten years.) This finding was extremely important as it indicated that the problem is one largely for long-standing diabetic patients.
Some people had written in alarming detail to the BDA, reporting experiences similar to those of the correspondent who complained: 'For 4 1/2 years I was on human insulin. It was the most difficult and distressing 4 1/2 years I have ever spent; in fact it was the only time during the two decades I have been diabetic that I actually felt handicapped.' Over a quarter of the letter (27%) reported a deterioration in general health.
From these letters, the attitudes of health care professionals were identified as being at least partly to blame. The report concluded that the change over to human insulin was little discussed with these diabetic patients. Although few correspondents actually complained about this, 'there was a general felling that the change had been foisted on them, and that they were either unclear of unconvinced what advantages there might be'. People also complained that their experiences were frequently discounted when they were reported in the clinic. Many of these people were dismissed with comments such as 'other people have changed over to human insulin without difficulty', 'no-one else is complaining of such symptoms', or it was all 'just in the mind'. Nine percent reported that they had asked to be changed back onto animal insulin and been refused.
Although it was argued that the sample of people who had written was clearly a biased one; the letters were mostly from people experiencing problems. It was also felt that such a body of evidence reflected the nature of the problem, where it existed, within the affected members of the diabetic population.
The positive side of this report, however, stressed that it was possible for some patients to reverse the effects following their change to human insulin. One in five correspondents mentioned that they had returned to animal insulin and, of these, 95% reported the return of warning symptoms, improved control and an increased feeling of well being. It also presented an opportunity to outline the lessons which health care professionals had learned from this issue.
Even when there is a scientific reason for the assumption of benefit from a change in insulin regimen, patients need to be involved in the discussion process. The report highlighted the need for negotiation between the health care professional and the person with diabetes. It also maintained that willingness was needed on the part of the professional to listen to what s/he was being told and to review the patient's treatment in light of their experiences. It is thus to be hoped that what was initially a terrible experience for some of these people with diabetes, has been turned to the benefit of others resulting in better relationships between people with diabetes and their health care professionals.
The patient's perspective
27 year old Fiona O'connell is one person who will definitely be supporting the BDA's Insulin Campaign. A year after she changed to human insulin, Fiona experienced some severe hypos which were totally unexpected and which were not accompanied by any warning symptoms. "One of my biggest fears was that of losing control of myself," she says. "I used to dread that happening. I would test on a regular basis, but my blood glucose levels would fall very rapidly without my realizing. Sometimes I would go lower than 36 mg/dl without having any idea I was on the verge of having a hypo."
One year ago, Fiona converted from human insulin back to animal insulin, but it took her nine years to make the changeover. The problems she was having with severe hypoglycemia had robbed her of her confidence, and she was reluctant to stop using her pen injector. However, she stresses that she had no criticisms of the doctors who were caring for her at the time. They were always helpful and willing to listen. Fiona feels that the BDA reacted inadequately to many of the problems surrounding type of insulin and hypo-glycemia when they arose, although she believes that the BDA has now taken on a more positive role.
"When the media was reporting the unexpected deaths issue, I had no idea what the BDA was doing about it," she explains, "and I would like to have known. I felt that people with diabetes were kept in the dark. It was an issue which no one seemed willing to discuss." Fiona appreciates that, at the time, the BDA thought that the best way to address the issue was to contact health care professionals so that they could pass the necessary information straight to their patients.
BDA Research Director, Dr. Moira Murphy, says: "I think we have learnt in retrospect that we didn't handle the issue in the best way probably because of such intense media interest. We were taking the reports we received very seriously, and were conveying this to the media and professionals and obviously not clearly enough to people with diabetes. It must have appeared that we were dismissing experienced such as Fiona's, but that was certainly not our intention."
Responding to the Issue
Suzanne Redmond, BDA Director of care, has been closely involved with the issue from the beginning and she agrees with Moira Murphy: "We were aware that some people were experiencing problems, but we also knew that the vast majority was not. We tried to find a way of responding to the issue without it distressing the many people who were on human insulin without problem.
"We were particularly concerned that we were receiving reports from people who had lost their hypo warning symptoms and had had driving accidents. We thought that if the BDA started to loudly publicize these problems with hypos, then it might cause problems for all people with diabetes regarding driving, employment and insurance, for instance."
Moira Murphy adds: "The issue has alerted us - the professionals, the researchers and everyone else - to the fact that hypoglycemia is a bigger problem than anyone realized and that people with diabetes actually had loss of warnings with much greater frequency that previously thought, so it led into new research programs funded by the BDA."
We always want to learn at the BDA. The call for better information for and communication with people with diabetes has been heard on numerous occasions and at a variety of events over recent years. We hope that this supplement and our Insulin Campaign will prove that the BDA is listening and acting on behalf of all people with diabetes.
0 comments - Dec 1, 1994