Half the patients had no warning of passing out during a hypo with the new drug
A quarter said such episodes were more frequent
One in five said they were more severe
Thirteen per cent said they became unconscious at night and five per cent suffered convulsions
Ten per cent had memory loss
Nine per cent said they lost their ability to concentrate.
Some people lost their jobs; other were refused renewal of their driving licences because they were involved in driving accidents during a hypo.
Even more worrying is that, in many cases, when a diabetic patient complained to their doctor about the human insulin, they were ignored. Although around one fifth of the patients in the survey switched back to animal insulin, many doctors refused to facilitate the switch or erroneously told their patients that animal insulin was no longer available. Not surprisingly, in some cases, the relationship between doctor and patient broke down because the patient felt that their fears were not being taken seriously.
Other experts also noted problems with synthetic insulin. In October 1997, Jenny Hirst, co-chair of the UK Insulin Dependent Diabetes Trust (IDDT) and a Trustee of the BDA at the time their report was being compiled, spoke at a conference organised by the Consumers for Ethics in Research (CERES). She revealed that the changeover to synthetic insulin often took place without the patient even knowing or without discussion ". . . a letter in the post or the pharmacist just gave them different insulin with no warnings. Our doctors assumed that 'human' insulin would be cheaper and better assumptions with no evidence except drug company sales patter."
Ms Hirst felt so strongly about the issue of deception that she resigned from the BDA, and formed the IDDT to compile and disseminate better information to diabetics.
The medical profession has taken little notice of such problems and, today, it is nearly impossible to obtain animal insulin anywhere. In 1998, Eli Lilly and Company stopped making its mixed beef and pork insulin. Because there is so little official follow up of people who have switched, we may never know the extent to which patients are suffering because of the change.
The scandal of synthetic human insulin is that it has been introduced on the basis of very little research. The first published study involved 17 diabetic men and was published in 1980 (Lancet, 1980; ii: 398-401). By 1982, human insulin was licenced and on the market. This was a remarkably short time considering this was the first genetically produced drug ever to be used on humans.
There has never been any evidence to show that synthetic human insulin has advantages over animal insulin. Those studies which do exist have been funded mainly by drug manufacturers and tend to be biased towards the drug. Bearing in mind the number of people who are dependent on insulin to live, the dearth of large scale long term studies is an issue of great concern, and one that continues to dog 'human' insulin. Most studies into its efficacy have used no more than 50 patients (Lancet, 1992; 339: 1432-5) and as few as 17 (BMJ, 1993; 306: 167-71). Such small studies are unlikely to have the power to detect significant problems.
While anecdotal evidence continued to mount regarding the problems with human insulin, the medical profession and government agencies staunchly defended its use (BMJ, 1992; 305; 355-7). And, while many IDDM sufferers would very much like to find a way to reduce their intake of insulin, signs are that the medical profession is widening the net of just exactly who gets insulin. Trials such as the DPT-1 trial are on going in the US, giving those at high risk of developing IDDM prophylactic doses of human insulin even before they show signs of the disease. Participants for these trials are partly selected on the basis of genetic risk. Yet, only 5-10 per cent of cases of IDDM are the result of genetic risk. We have no way of knowing what side effects this genetically engineered drug may have on a healthy body.