Insulin Dependent Diabetes Trust International
P.O. Box 294
Northampton UK, NNI 4XS

1st November 1999
Letter to the Editor
The Indianapolis Star

Dear Sir,

I would like to congratulate Jeff Swiatek on his article, Oct. 31 1999, about the issues relating to biosynthetic so-called 'human' insulin and natural beef and pork insulins and also to express deep concern from the UK for all the people in the US that are being denied the beef/pork insulin they need. Although Novo Nordisk are systematically withdrawing their natural animal insulins from the UK, we are fortunate to have an alternative supplier, CP Pharmaceuticals, as mentioned in the article.

But we are also fortunate in that our Committee on the Safety of Medicines, the equivalent to the FDA, does recognise that some people are unable to use biosynthetic insulins and issued a statement to that effect, August 19, 1999. In the UK we do have easy access to the number and type of reported adverse reactions so the truth is much more obvious here and perhaps this explains why two leading regulatory bodies can come to such different conclusions.

In addition to this, there is a further admittance of the problems from Novo Nordisk in their press release, Sept. 9 1999 which says 'Historically improving glycaemic control with soluble human insulin has been associated with an increased risk of hypoglycaemia ( hypoglycemia , insulin shock, insulin reaction ).' Yet again interesting that the two leading insulin manufacturers can have such different views. For Holcomb, the Lilly physician, to suggest that people who cannot get on with human insulin haven't tried, is insulting to patients and even more insulting to their physicians. For Zimmerman, President of the ADA, to suggest that patients who need animal insulin are simply 'emotional' shows his total disregard and somewhat outdated view of patient participation in healthcare issues.

It is worth pointing out that the initial research into this first ever, biosyntheically produced drug was carried out in only 300 people before marketing approval. No large scale, long-term double blind studies comparing natural and synthetic insulins have ever been carried out. Most of the research referred to in the article were small studies carried out in a laboratory setting - not in a real life environment. This is why the problems have not been shown. Furthermore, the Diabetes Group of the Cochrane Collaboration presented a Review of the research into this issue at the British Diabetic Association Professional Conference earlier this year. Professor Rhys Williams pointed out that studies of the type carried out, do not exclude the possibility that there is a difference and that 7 out of 38 studies do show differences and these need an explanation. He also said that 'in some cases the increase in frequency of hypos and the lower awareness of an impending attack appeared to be linked to a number of deaths associated with 'human' insulin.

Finally I cannot help but comment that Holcomb's statement that animal insulin is antiquated. I would suggest that it was perhaps their animal insulin plant that was antiquated and bringing it up to required modern standards was more costly than converting it into a car park. Having visited CP Pharmaceuticals' new production plant I certainly do not get the impression that there is anything antiquated about natural animal insulins.

Jenny Hirst

Insulin Dependent Diabetes Trust - International