Evidence that thousands of diabetics in Britain may have suffered a deterioration in their health from genetically-engineered insulin has been withheld by the British Diabetics Association, whose role is to advise patients and to protect their interests.
The evidence was contained in a report, commissioned by the association and completed in 1993, which highlighted dangers faced by about 10 per cent of the 150,000 diabetics who had been switched from the traditional animal-derived insulin to genetically-engineered human insulin.
Some adversely affected began, without warning, to go into comas, known as hypoglycaemic episodes or ,hypos". Same suffered severe injuries, a few crashed their cars, and others believed they would have died had they not been rescued as they lay unconscious. An estimated 15,000 people may still suffer because they are injecting themselves twice a day with insulin that may not suit them.
Many doctors are unaware of the problem, or have failed to put their patients back on animal insulin because they do not know it is still available. The association says it did not publish the report because it was ,,too alarmist". Simon O'Neill, head of diabetes care services, said the association agreed that up to 20 % of insulin injectors preferred animal insulin and had experienced difficulties with genetically-engineered insulin. He added that the association had published a report, The Insulin Debate, which kept members informed of developments, and campaigned to keep animal insulin available to sufferers.
Genetically-engineered insulin is manufactured by the drug companies, the Danish Novo Nordisk and Elli Lilly. Neither accepts that the genetically-engineered version has negative effects.
The report was compiled following 3,000 letters of complaint over two years about the new insulin from association members. The letters told how lives had deteriorated after being switched to genetically-engineered human insulin. Eight out of 10 of a sample of the complainants examined by independent researchers said they could no longer control their symptoms and had lost warning signs of impending comas. The main conclusions from the letters were:
Matthew Kiln a south London GP who is an expert on diabetes, was a member of the committee of inquiry set up by the association that looked into the side-effects of genetically-engineered human insulin. He told the Guardian: "The association has failed in its duty to protect and represent the interests of diabetics by not publishing the committee's findings in full. I and other doctors who understand this issue have been quietly switching some patients back to animal Insulin to avoid the problems but thousands of people are suffering from lack of choice."
Dr. Kiln is himself a diabetic who uses insulin and has experienced the negative effects when he switched to the genetically-engineered version. Before genetically-engineered human insulin was introduced in the early 1980s around 150,000 diabetics in Britain injected themselves twice a day with insulin extracted from pigs and cattle in slaughterhouses. Diabetes is the result of the body's inability to produce insulin which regulates blood sugar levels but it can be successfully managed by injecting animal insulin. Genetically-engineered human insulin, made from feeding nutrients to E-coli bacteria, was heralded as a breakthrough because it would avoid an occasional long term problem of antibodies being produced to combat animal insulin.
After the association received a tide of complaints, it commissioned two independent researchers, Hazel Matthews and Natasha Posner, to analyse some of the letters. Their report concluded that many patients were suffering potentially dangerous reactions. A fuller report ordered from Dr Posner concluded that doctors and specialists had failed to listen to patients and the distress and dangerous symptoms had been largely ignored. The report was due to the published in the British Medical Journal in 1993 but was withdrawn. The Diabetic Association's Journal, Balance, subsequently produced a supplement, The Insulin Debate, in which some of the problems of genetically-engineered insulin were discussed. O'Neill said the BDA continued to educate medical staff of the need to give diabetics the option of using animal insulin. He said: "The message of the Posner report was right, it was just too alarmist, but it is a message we have disseminated. It is a message we're still trying to get out. We've campaigned to stop animal insulin being withdrawn. Matt Kiln and we are on the same side."
The 3,000 letters of complaint written to the British Diabetic Association by patients, their relatives and doctors concerned the deterioration in their condition since being moved from animal insulin to genetically-engineered human insulin. After analysing nearly 400 of the letters, Natasha Posner, an independent researchers commissioned by the DBA, said: "Many correspondents reported that a diabetic condition which had been stable and controlled over many years and allowed a full and normal Iife, suddenly changed and became problematic and life disrupting. For people experiencing these difficulties, the cost in terms of immediate negative effects far out-weighed any possible long term benefits of this new insulin."
The report says that in many cases where the patient had complained, the relationship between the diabetic and doctor was breaking down and there was a potential for conflict because the patient felt his fears had been ignored.
The single most important complaint was the sudden onset of comas. A second problem was personality changes, mostly noticed by partners and colleagues. A third, and of great concern to the association, was a breakdown in relationship between the diabetics who manage their illness, and the professionals who advise them and prescribe their insulin.
There was also strong evidence that the problems were reversible. One fifth of the patients in the survey switched back to animal insulin. Of these only 1 per cent said there was no improvement when they returned to animal insulin. Many doctors refused to change them back or told them erroneously there was no longer an animal alternative.
"Correspondents reported the consequences of loss of control of the diabetes, deterioration in general health or accidents meant increased dependence an others and loss of confidence about controlling the diabetes so that there was fear of going out alone, going to bed or driving."
"Some people had lost their job, been made redundant or found that they were unable to work. A few had been refused renewal of their driving licences. There were several reports of people who had been prosecuted by police after being involved in accidents while having a hypo," the report said. The report concludes:"The letters examined constitute a source of data which amount to very much more than mere anecdotes."
Patients' comments were directly quoted in the report:
"While I was an human insulin, my life was absolute hell. There was absolutely no warning of my blood sugar going low, and I have been in several comas because of this. My cIinic put me back an to animal insulin in July, and I have felt a different person since."
"It was only when I went an to human insulin that I thought I was not in control of my diabetes, I went into hypos almost daily with no warning whatsover (thanks to paramedics and good neighbours plus the casualty department at the local hospital I am still here to tell the tale)."
One patient reported that his family noticed: "The complete change of character. I was becoming moody critical, confused, forgetful and seemed to lack concentration. But more and more I seemed to have unnoticed hypos."
From a wife: "There is no doubt in my mind that had be been living alone he would now be dead, Many of the hypos occur during the night for no reason."
From a mother "The clinic argues that the human insulin is better for him in the long run than animal insulin - that is if he can survive."
USA 1999: "Enforced switch to human insulin worries some diabetics"
After manufacturing stopp by Eli Lilly of their beef/pork mixed insulin ILETIN I - see under "Things look grim in the USA 1997" - human insulin victims report in the Journal of the American Medical Association
JAMA 1999; 281:121-122., i.e.:
"... The results with human based insulin were disastrous. The changes in my overall feeling of well-being were immediat. The experience I had with Humulin was negative overall, ranging from loss of what had been relatively good diabetic control, to feeling strange in general, to experiencing the more serious hypoglycemic unawareness episodes. In 20-plus years with diabets I had never lost consciousness because of hypoglycemic reaction until I switched from ILETIN I to Humulin."...
The American Diabetes Association (ADA) asked about their concerns, that there may be an increase this summer of "dead in bed syndrome" facing diabetics their chief scientific and medical officer said:
"We're a little nervous, but biologically there should be no reason why you can't switch over..."
Meanwhile are the "Tips for Easing the Transfer to Human Insulin" by Eli Lilly and Company at the end of the article not reassuring any animal insulin dependent diabetic!
IDDT (Insulin Dependent Diabetes Trust) UK and USAare dedicated to the preservation of range and variety in insulins for those who use it: For more information and what you can do look at:
1997: Things look grim in the USA: "Lilly Beef/Pork Insulin on the Endangered Species List":
Eli Lilly, the manufacturer of 80 % of America's insulin is planning to take ILETIN I (beef/pork) insulins off the market. Lilly has made no formal public announcement of these plans, but since May of this year anyone who calls Lilly's customer service line (800-545-5979) is politely informed that, "Production will cease in 1998, and it is expected that the stock will be completely depleted some time in 1999."
What does that mean for the estimated 300,000 in the United States who depend on ILETIN I ?... starts on the front page of Diabetes Interview (October 1997) a report about a number of controversial issues surrounding the Lilly decision. Three National Diabetes Organizations provide statements on animal insulin: The Canadian (CDA), British (BDA) and American (ADA) Diabetes Associations:
As the CDA states : "Our survey results indicate that for some people, changing insulins has a negative impact on their health, well-being and quality of life... " and "CDA is committed to advocating for the continuation of beef/pork insulins for those who will be affected by the switch to human insulin... "
The BDA notes: "A sizeable minority of people prefer animal insulins and claim human insulin causes them to experience loss of warning signals for hypoglycemia, though, BDA argues ther is no direct evidence from clinical research of such a link." ... "Quite clearly, however, a lot of people have concerns and feel happier on animal insulins and the BDA supports their right to chose the insulin that suits them best". ADA recognizes: "... patients' concern with the discontinuation of mixed beef/pork insulin production in the United States." "... The ADA acknowledges that human insulin will inevitably replace all forms of animal insulin ..."
The Editor in Chief ends up with "My own injection":
"Who is going to advocate for those people in the United States whose health, well-being or quality of life will be affected by the enforced change to human insulin? This is of special concern because unlike Britain and Canada, the US have no socialized medicine. Many here won't have a doctor who is able to coach them through the significant changes in lifestyle and dosing that accompany an insulin species transfer!"
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