Synthetic ‘human’ insulin versus natural animal insulin

IDDT campaigning

Pork and beef insulins available in the UK
Synthetic ‘human’ insulin versus natural animal insulin
Animal insulin – Minister’s letter
Limiting availability of blood glucose test strips

Back to Here to Help

Synthetic ‘human’ insulin versus natural animal insulin

IDDT has campaigned for the continued availability of pork and beef insulins since its formation in 1994 when significant numbers of people experienced adverse effects from synthetic human insulins. The continued availability of animal insulins was threatened which would deny people the insulin they need to remain healthy. The major insulin manufacturers ignored the needs of this significant minority of people with diabetes and in 2007 they discontinued manufacture of animal insulin. However, thanks to a smaller supplier, Wockhardt UK, the UK is one of the very few countries where pork and beef insulins are still available.
By the late 1990s  the major insulin manufacturers introduced insulin analogues and these synthetic insulins also caused some people to have adverse effects, all too often not acknowledged by their doctors and diabetes team.

Below is a summary of the lobbying campaign carried out by IDDT and its members – it’s a record of how we did it!

The Campaign Aims:

• full recognition of the adverse effects of ‘human’ insulin in some people
• an indefinite availability of pork and beef insulins to suit the needs of ALL people requiring insulin therapy
• that all people receiving insulin treatment are given an informed choice of treatment, including the risks and benefits of ALL types of insulin.

  Discontinuation of animal insulin has already happened in most EU countries – it is likely to happen in the UK unless we ACT!

Facts during this time

• Discontinuation of animal insulins is for commercial reasons and this means that insulin treatment choices are being dictated by pharmaceutical companies and NOT the medical profession or patient need.
• Animal insulins have been used safely and effectively for over 70years. There is no evidence to show that synthetic GM ‘human’ insulins are better than animal insulins [Cochrane Review 2003]
• Comparison of regular ‘human’ insulin and short-acting insulin analogues showed only minor benefit with analogues in some people [Cochrane Review, May 2004] but due to fears of potentially carcinogenic and proliferative effects, most studies to date have excluded patients with advanced diabetic complications.
• Both Cochrane reviews showed that majority of this research to compare the above insulins was ‘methodologically poor’ and importantly for patients, there has been no research to compare patient-oriented outcomes such as mortality and complication rates and quality of life [Cochrane Reviews 2003 and 2004].

Campaign Update

The campaign achievements so far…
Thank you to everyone who has written and re-written to their MPs and MEPs about Novo Nordisk’s possible discontinuation of animal insulin. Your help has been invaluable in the campaign and has given credibility and support to the many Westminster meetings the Trustees have had with MPs of all parties. IDDT is also very grateful to the many MPs and MEPs for their understanding and support and for taking up the issues in the House of Commons, directly with the Minister of Health and with the insulin manufacturers.

Understandably many people have felt angry and frustrated at some of the replies your MPs have received from Rosie Winterton, Minister of Health, and Lord Warner, the Under Secretary of State for Health. But by continuing to respond through your MP, you are putting our case more strongly and sending the message that we are not going to be fobbed off with half-truths and spin on the evidence.

Parliamentary Questions
Over 30 Parliamentary Questions have been asked of the Minister of Health, Rosie Winterton. One of the many supportive MPs, Tim Loughton, has been very supportive and asked many PQs on our behalf and is to pursue the following points:

1. Government research into comparing animal and synthetic insulins
2. Why doctors are not giving patients a fully informed choice of insulins
3. Why the NHS is paying more for synthetic insulins that are not superior to animal insulins for the majority of patients
4. That there must be a better education programme for people with diabetes and this MUST include patients being given a fully informed choice of ALL insulins.

Novo Nordisk agree some people can’t tolerate GM insulin and delay their decision
Novo Nordisk has agreed to delay their final decision about future availability of animal insulin until summer 2005 so supplies should continue until the end of 2006 or into 2007. In a statement from their Chief Executive in the UK, Novo Nordisk acknowledged that some people can’t tolerate synthetic insulin and the importance of this statement must not be underestimated. “The company is aware that there are people with diabetes who are only able to tolerate animal insulins.”

• It has taken 20years and pressure from you and your MPs to achieve this acknowledgement and the importance of this statement must not be underestimated:
• It directly supports our lobbying for the indefinite supply of animal insulin for the people “who are only able to tolerate animal insulin”. With a statement like this, if the government doesn’t ensure continued supplies, they are knowingly condemning people to a treatment they can’t tolerate and this is an unthinkable position.
• It questions the safety and medical ethics of transferring patients “who are only able to tolerate animal insulin” to any synthetic GM insulin, including insulin analogues.
• It leaves doctors who prescribe any of the synthetic insulins to patients “only able to tolerate animal insulin” in a very vulnerable and unenviable position, a similar position to prescribing penicillin for a patient known to be allergic to it.

Meeting with Dept of Health civil servants, May 2004
IDDT expressed our concerns that CP Pharmaceuticals [now Wockhardt UK], the other animal insulin manufacturer in the UK, may not be able to meet the increased demand for pork insulin should Novo Nordisk decide to discontinue their pork insulin. This was discussed at a meeting with the Dept of Health in May and since then Lord Warner has stated:
“CP have given assurances that it currently has no plans to stop the supply of animal insulin. CP have confirmed to the Dept officials that they could meet any increased demand for animal insulin within a maximum of three to four months.”

Through their MPs IDDT members persisted in expressing their concerns about only having one supplier and in August 2004 Lord Warner made the following statement:
“Should one of the two companies supplying animal insulin in the UK decide to withdraw their product, the Dept of Health will take whatever steps are necessary to help ensure that patients continue to receive the treatment they need.”

This undoubtedly is progress. It answers goes some way to answer the key question we asked the Dept of Health about who is responsible for ensuring that UK citizens have the essential medicines they require. Lord Warner certainly suggests that the Dept of Health is responsible but what does he mean by ‘treatment’? All insulins lower blood glucose levels and simply lowering blood sugars could be classed as the treatment so we need greater clarification as follows:

• We need a categorical statement that this promised treatment will in fact be with animal insulin. We cannot risk that this decision will be in the hands of the doctors and nurses who have never believed that there are adverse reactions to synthetic GM insulin. We need to be categorically assured that we, as patients, will be actively involved in this decision and that this will not be a battleground where patients have to be assertive to continue to receive animal insulin.
• We need to be assured that animal insulins remain available as a choice of treatment for everyone requiring insulin. The phrase “patients continue to receive the treatment they need” suggests that all the Department will do is ensure those already using animal insulin will continue to receive it. This is not good enough. IDDT continues to receive new reports of adverse reactions with ‘human’ insulin and with all the new analogues and if animal insulins are not freely available now and in the future, these people will be forced to remain on a type of insulin that adversely affects their health and lives.
• Animal insulin must remain available now and in the future and for everyone, not just for those presently using it.
• We need steps to be taken to ensure that everyone requiring insulin is made fully aware that animal insulin is available and that synthetic GM insulins do cause adverse reactions in some people. It is essential that this is done by hospital clinics and not by a charity.

Adjournment Debate, November 16th 2004
David Amess MP led an Adjournment Debate on Diabetes and requested assurances about future supplies of animal insulin. Dr Stephen Ladyman, Parliamentary Under-secretary of State for Health responded for the Government with: “Were we to become aware of such plans [to discontinue], we would, of course, express a view, and our clear view is that which type of insulin a patient receives should be a clinical decision. That decision certainly should not be controlled by commercial considerations or issues of availability.”

Meeting with the Minister, December 7th 2004
Thanks to David Hinchliffe MP, Chairman of the Health Select Committee, a meeting was arranged between IDDT with the Minister of Health, Rosie Winterton. The Minister:
[i] supported the statement made by Dr Ladyman that choice of insulin treatment should not be dictated by commercial considerations or availability.
[ii] agreed to look into the ability of CP Pharmaceuticals to meet the increased demand for animal insulin in the event that Novo Nordisk decides to discontinue production, especially in the light of their recent out-of-stock position.
[iii] agreed patients must have an informed choice of treatment and steps would be taken, such to try to ensure that both patients and healthcare professionals are made aware of the availability of animal insulin eg information on the Dept of Health website. IDDT made the point that this information should be full and complete and include the fact that both human and analogue insulins have the potential for carcinogenic effects with analogues having the greater potential, and that animal insulins have no such effects.

We are making progress and it is encouraging that we now have supportive MPs who clearly recognise that some people cannot tolerate synthetic insulins. Like many of us, they see the unfairness and the risks associated with denying people the insulin they need and they have difficulty in finding an explanation, especially when a known 30,000 people is not an in significant number.

We ask everyone who cares about people with diabetes to join our campaign to ensure that the choice of natural animal insulins remain available for the people who need it and cannot tolerate the only alternative -synthetic GM insulin. But our campaign has wider implications as it clearly demonstrates that it is the very powerful pharmaceutical industry that can dictate treatment choices irrespective of doctors and patients’ needs and wishes.

Discontinuation of animal insulin has already happened in most EU countries – it is likely to happen in the UK unless we ACT NOW!

Please help! We will supply you with a lobbying pack.

Meeting with Health Minister, Rt Hon Jane Kennedy, 2005
After continued lobbying by IDDT and our members, a meeting was held with the then Health Minister and Dept of Health civil servants. As a result of this meeting, Jane Kennedy conformed that ‘some people are better suited to animal insulins and so they must continue to be available.’

2005 onwards
Pork and beef insulins from Wockhardt UK [formerly CP Pharmaceuticals] have continued to available in the UK. IDDT keeps a watchful eye on this situation but should the situation change in anyway, then in no uncertain terms, we will remind the government of the 2005 statement by the then Heath Minister, Jane Kennedy.