I received copies of 41 letters from the BDA's correspondence file relating to human insulin. I understand these had been selected randomly in so far as they included all the letters from people with surname beginning with one of 3 letters of the alphabet. I do not know which particular letters were chosen names and other identifying material had been deleted from the copies.

Two of the letters were from professionals. One enclosed a paper intended for publication in January 1990 which discussed an increase in the number of deaths of insulin dependent diabetics referred (apparently to a pathologist) for investigation. However none of these cases had been reported to the Committee on Safety of Medicines and the writer concluded "there appears … to be a long way from hypoglycaemia to death". (25)

The second, dated May 1990, reported an examination of death records in Scotland which "show no evidence to support allegations against human insulin". (30)

A third letter came from the secretary of a local group. The remainder were from individuals. Two of the 38 seem to be from the same person (handwriting and events reported are similar) so we have information on 37 people.

More than half (21 out of 37) letters were written by the person suffering from diabetes and the rest concerned relatives of a diabetic husband (7), wife (1), fiancé (1), daughter (2), son (1), brother (1), mother (1), father-in-law (1),. Six were writing about a diabetic who had died.

Timing

The letters which had legible dates (24 of the 41) were written between January 1989 and May 1992. There were two clustering's, 6 in October / November 1989 and 12 between August and November 1991. Five of the first group referred to a TV programme (or programmes), specifically one on 12 October 1989. The second, larger group appear to be prompted by articles in the national papers and a "Watchdog" programme on TV in October 1991. Some of these refer to possible court action for damages against the manufacturers of human insulin.

Problems

Nearly all the writers had a problem to report which they associated with a change from animal to human insulin. Most problems resulted from lack of warning of a hypoglycaemic episode. Some sound like very serious problems;

"My husband is a diabetic on two injections a day. In 1986 he was changed from (pig) Actrapid & Monotard to (human). We were under the impression that the pig insulin was no longer available. Since that day my husband has been ill. He has been continually depressed for 5 years, he also has terrible hypo attacks, one morning I woke to find him on the floor having what could only be described as an epileptic fit. This was a hypo that had gone too far as he hadn't woken. He is also tired all the time he is only 33 but has the body and energy of someone in their 60's … (41)

Is it possible for someone to explain to me why my husband's comas have changed since he has been on the new insulin. When he was having injections of animal insulin he always had plenty of warning when his blood glucose was getting low, giving me plenty of time to give him glucose preventing a hypo coma or getting medical help or an ambulance. Now, within seconds of him feeling bad he goes into what look like a fit. His eyes roll back, his head quite suddenly turns to the right side, his breathing is very quick, his body arms and legs go stiff and twisted. This lasts for 3 to 5 minutes. Then he goes into a coma, at this stage his body relaxes, he looks very white-grey and sweating. It is only at this stage that I can get help. I am always afraid that one day I will have left it too late, but what can I do when I can't leave my husband in such a distressed condition. When my husband does come round from the coma he panics, I have to stay with him to grab him quickly in case he hurts himself throwing his arms and body around. I have noticed after his comas he has very bad constriction (?), really worn out and pain in his chest and limbs. Bed wetting happens now and then. My husband is now completely blind. If he has a hypo coma outside or when I am out shopping he cannot do anything to help himself as the insulin causes his blood sugar to drop quickly. I dread the thought of coming in one day from shopping and finding him dead. This I feel is possible. (4)

"…four years ago (my husband) was put on Humalin insulin, after just two weeks he became so ill being very depressed, had no strength, used to sit and cry for no reason at all. Could not eat or sleep, … also .. he had a very bad hypo and it took a two pound bag of sugar to get him round and then he only had a blood sugar of 2%", (22)

"prior to my introduction to this insulin 5 years ago, I had virtually no problems with my diabetic control. From the onset of its use I have experienced the most horrific hypoglycaemic re-actions at night. On the very first occasion I thought that I'd had a stroke since I woke up unable to move my right side and unable to speak properly. Needless to say - I was extremely frightened. My husband comforted me and with no further action the symptoms gradually disappeared. It took a neurologist to diagnose the problem as a Hypo. Since that first occasion the Hypos have changed and have become even more unpleasant. Now I sometimes have no warning of an impending Hypo, and but for the astute awareness of my husband of the slight symptoms that precede these attacks (ie body temperature cold but clammy, and jerky movement), the results could be very serious. I have been told that if undetected - for instance when my husband is away on business - it could lead to permanent brain damage, or even death! My last attack persuaded me that there is some truth in this, as besides being left exhausted, I could remember nothing of the previous day until my husband talked me through it. This only lasted half to one hour, but it seemed like forever." (16)

"I .. had a devastating accident …this year and later this month will be returning to hospital for another major operation on my leg. There was absolutely no warning of a low blood sugar & I collapsed down 5 stone steps" (5)

"After starting human insulin I found a marked difference in the onset of hypos - I described it to the diabetic consultant as being like stepping into a deep hole while walking along quite naturally and although a ladder was there (ie glucose tablets in the pocket) you were unable to see or use it. It was as sudden as being cracked on the head from behind and I had several lucky narrow squeaks". (13)

"To my absolute horror, I was cooking my dinner on 24th August, and I had no time to pick up my dextrosol tablets, when I went flat out into a coma, and my full weight of body went on my right ankle. My husband revived me, and I said 'Call an ambulance please, I felt my ankle snap.' I ..,. have two pins in the ankle, and I was kept in (hospital) for one month and two days. Whilst I was there they put me back on my old insulin, with a lesser dosage, and I am now feeling very fit, and so far, no hypos whatsoever …(but) I am completely incapacitated, and very very upset. This letter ends: I am 76 years old … My husband is 80 years old. We had a good life which is now wrecked. (9)