Animal insulin – Minister’s letter

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Animal insulin – Minister’s letter

From the Minister of State
The Rt Hon Jane Kennedy MP

Department of Health
Richmond House
79 Whitehall
London
2NS

24.7.05

Jenny Hirst
Insulin Dependent Diabetes Trust
PO Box 294
Northampton
NN1 4XS

Dear Ms Hirst,

Thank you for coming to meet me at Portcullis House on July 11th, to discuss your concerns about the continuing availability of animal insulin.

May I first of all say that the Department of Health fully accepts that some people are better suited to animal insulin, and that animal insulin should continue to be made available. At this time, neither of the two suppliers of animal insulin to the UK has informed us that it intends to stop supply it, although Novo Nordisk says that it will make a decision in 2006.

We have again sought assurances from Wockhardt that it has no plans to discontinue supply of animal insulins. The company says that animal insulins continue to be key products for it. As part of an investment program in its UK sterile manufacturing facilities, production capacities for such products will be significantly enhanced over the next 6 to 12 months. The company says that this investment is essential in order for it to take full advantage of the commercial opportunities that may present themselves, including in the animal insulin market.

Although the market for animal insulin is relatively small, Wockhardt has recently underlined its commitment in this field by seeking registration of its porcine insulin range in Canada. It is expected that Canadian Marketing Authorisations will be in place before the end of the year, which will mean that patients currently being prescribed animal insulin from Eli Lilly, will have an alternative when this is withdrawn from the market early in 2006. Wockhardt has been working closely with Lilly and Health Canada to ensure that there is continuity of supply for patients who wish to continue taking porcine insulins.

As far as adverse effects of human insulin are concerned, it is current clinica practice to start patients on human insulins and there is no clinical evidence that human insulins cause any more adverse reactions than animal insulins. This view  has overwhelming clinical and professional support, and is borne out by the July 2000 Duabetes UK comparative report on all the various animal versus human insulin studies (as the British Diabetic Association).

We have considered whether further (non company) research might be carried out on the adverse effects of human insulin, but given the high demand on R&D budgets for research on subjects of high clinical and policy priority we have concluded that there seems little justification for commissioning research at this time. However you may wish to be aware that there is an ongoing (company-sponsored) study to examine the incidence of serious adverse drug reactions in 4,000 patients receiving the recombinant human insulin insulin analogue determir (brand name Levermir) – the findings from this study will be reviewed by the MHRA.

During our meeting, we discussed how the profile of the issue might be raised, particularly with doctors. As you will be aware, there have been two previous articles on hypoglycaemia unawareness on transferring from animal to human insulin in the MHRA’s drug safety bulletin "Current Problems in Pharmacovigilance", the most recent in September 2000. I have asked officials to make arrangements for another article to appear in the near future. I have also asked them to liaise with National Diabetes Support Team (NSDT) on the possibility of including an article on the Yellow Card Scheme on its next briefing and to discuss with Diabetes UK the possibility of inclusion on their website of a link to www.yellow.gov.uk where patients can report suspected ADRs.

Finally, the MHRA is currently taking forward the recommendations of the Independent Review of Access to the Yellow Card Scheme including patient reporting, access to Yellow Card Data and proposals for increasing awareness of the Scheme.

I hope this is helpful.

Yours sincerely

JANE KENNEDY