Campaign succeeds - synthetic GM 'Human' insulin versus natural animal insulin
Implementation of National Service Framework for Diabetes
Affordable accessible insulin for people in developing countries
No blood meters for blind and visually impaired people
Direct to consumer advertising of drugs
Campaign Succeeds - Synthetic GM ‘human’ insulin versus natural animal insulin
Animal derived insulins have been used to treat people with diabetes since insulin was first discovered and since the 1970s it has been highly purified. Genetically produced so-called ‘human’ insulin was introduced in 1982 and now the vast majority of people requiring insulin treatment are prescribed synthetic GM ‘human’ insulins or their successors, insulin analogues. However, after more than 20years there is still no evidence that synthetic GM insulins have any clinical benefits for patients and they cost the NHS significantly more than animal insulins.
A significant minority of people experience adverse reactions when treated with synthetic insulin and these adverse reactions often disappear with a change to natural animal insulin. The adverse reactions affect the ability to satisfactorily control blood glucose levels, the ability to recognise low blood glucose levels [hypoglycaemia] preventing remedial action being taken so increasing the risk of coma and even death. The other reported adverse reactions are large weight increase, extreme tiredness, memory loss, behavioural changes, joint and muscle pains.
Patients reporting these adverse reactions are often not believed by their doctor and/or healthcare professionals with some patients even being denied their request to be transferred to animal insulin. Others are given misinformation about the claimed superiority of GM ‘human’ insulin and the lack of availability of animal insulin. People are rarely given a choice of insulin treatment with information about risks and benefits and so are denied the informed choice of treatment to which they are entitled.
‘Human’ insulin was originally thought to have advantages over natural animal insulin but research has since demonstrated that it has no clinical advantages for patients over animal insulin and there is no evidence of long-term safety. Despite this the major insulin producing companies are systematically discontinuing animal insulins from countries around the world and it has been confirmed that this is their intention in the UK. This will leave people that need animal insulin without the treatment that they know from experience suits them best and the treatment they need to maintain their health and quality of life.
Discontinuation of animal insulin has already happened in most countries but patients in the UK have fought for nearly 20years to ensure that this does not happen in the UK!
Our campaign became more urgent when we learned of the growing threat to future supplies of animal insulin.
In October 2002, Novo Nordisk Pharmaceuticals Ltd informed IDDT that they would not be discontinuing their animal insulin but later announced that they would be taking a final decision about future availability of animal insulin in the summer of 2004, promising 18 months notice of any discontinuations.
IDDT was assured that Wockhardt UK [CP Pharmaceuticals] will continue to supply pork and beef insulins in vials and cartridges for the foreseeable future. However, the company had supply problems for 9 months during 2004/05 demonstrating the vulnerability of having only one supplier for the 30,000 people in the UK who need animal insulin.
- 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.
IDDT sustained and vigorous campaign!
We had a sustained and vigorous campaign to persuade the Department of Health to 'lean on' animal insulin manufacturers to ensure that animal insulin continues to be readily available to those who require it. IDDT formally stepped up the lobbying campaign by asking members to write to their elected representatives, MPs and MEPs explaining the effects that a lack of animal insulin on their health and quality of life.
Here are the facts:
- The majority of people appear to be able to use synthetic GM insulins satisfactorily but there are over 30,000 people in the UK alone who cannot tolerate it and need animal insulin.
- 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].
IDDT is grateful to the many MPs and MEPs for their understanding and support for our campaign. They have taken up the issues in the House of Commons, directly with the Minister of Health and with the insulin manufacturers.
The campaign achievements:
Over 40 Parliamentary Questions were asked of the Minister of Health, Rosie Winterton and some of the many points that were pursued included the following:
- The need for Government research into comparing animal and synthetic insulins
- Why doctors are not giving patients a fully informed choice of insulins
- Why the NHS is paying more for synthetic insulins that are not superior to animal insulins for the majority of patients
- 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 delay decision
Novo Nordisk agreed to delay their final decision about future availability of animal insulin until summer 2005. This has not yet taken place and 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.":
Meeting with Dept of Health civil servants, May 2004
- Following this meeting Lord Warner, Secretary of State for Health stated: "CP Pharmaceuticals have given assurances that it currently has no plans to stop the supply of animal insulin….. they could meet any increased demand for animal insulin within a maximum of three to four months."
- Lord Warner later stated [August 2004]: "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."
Adjournment Debate, November 16th 2004
David Amess, MP led an Adjournment Debate on and his request for assurances about future supplies of animal insulin was answered for the Government by Dr Stephen Ladyman.
"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
David Hinchliffe MP, Chairman of the Health Select Committee requested a meeting for IDDT with the Minister of Health, Rosie Winterton and she agreed to meet with us. The Minister:
- supported the statement made by Dr Ladyman that choice of insulin treatment should not be dictated by commercial considerations or availability.
- 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.
- 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.
Meeting with Minister of Health, The Rt Hon Jane Kennedy MP, July 11th 2005
With the help and support of Earl Howe, a productive meeting took place with the Minister and her civil servants following which IDDT received a letter from the Minister stating the following:
- "The Dept of Health fully accepts that some people are better suited to animal insulin, and that animal insulin should continue to be available."
- Novo will not be making a final decision about pork insulin until 2006 - so a delaying discontinuation for yet another year.
- Wockhardt [CP] are expanding their production facilities over the next 6 to 9months to take full advantage of the commercial opportunities that may present themselves and confirmed that they are seeking marketing authorisation in Canada where, only 3 weeks ago, Lilly announced total withdrawal of pork insulin in Canada and the US.
The Minister has also agreed that the profile of these issues should be raised, especially with doctors, and asked her civil servants to:
- arrange another article about the adverse effects of GM insulins in the MHRA's Bulletin "Current Problems in Pharmacovigilance"
- to liaise with the National Diabetes Support Team to include an article on the new Yellow Card Scheme whereby patients can report ADRs directly rather than through their doctors
- to discuss with Diabetes UK the possibility of inclusion on their website of a link to http://www.yellowcard.gov.uk/ where patients can report suspected adverse reactions.
Our campaign has succeeded!
The Dept of Health has acknowledged the adverse effects of GM insulins in some people and that animal insulin ahs to be available. Globally, we now have three governments acknowledging this and an EU Commission statement that Member States have the responsibility to supply both animal and 'human' insulin.
However, our work is not over:
- We are fully aware that the UK is likely to eventually have only one supplier of animal insulins in the UK and aware of the dangers and vulnerability for patients. We shall therefore be keeping a continuing watching brief.
- We are also aware that the Department's full acceptance that some patients have adverse reactions to GM insulins and need animal insulin is a message that has to be communicated to the medical and nursing professions in order to help and protect people with diabetes.
- We are also aware that there is a very real need to ensure that people with diabetes are given a fully informed choice of insulin treatment and that this requires a change of approach and attitude amongst many doctors and health professionals.
On behalf of all our members, IDDT would like to thank the many MPs and MEPs who have supported us. Without their help and persistence we would not have succeeded in achieving this great step forward for people who have for so long feared the discontinuation of the animal insulin they need to maintain their health and quality of life.
Further information can be obtained from Jenny Hirst, e-mail [email protected] Tel 01604 622837 or IDDT, PO Box 294, Northampton NN1 4XS
Implementation of National Service Framework for Diabetes
The NSF aims to provide good and equal standards of care for everyone with diabetes. We support these aims, although they are vague in some areas. However, the NSF is to be implemented by Primary Care Trusts. Unlike other NSFs there are no ring-fenced funds for implementation of the NSF for diabetes.
Many GP practices are lacking in diabetes expertise. The necessary skills can only be acquired by education programmes for all those working in primary care but this requires extra resources, both financial and staffing. There already is a shortage of consultants, dietitians, chiropodists and specialist nurses.
It is clear to see that without extra resources, the funding for implementation will have to be made by savings in other areas. Within months of the publication of the implementation plans, our Trust has received reports from several areas of the country that Primary Care Trusts are restricting or denying people with diabetes reagent strips for self-monitoring of their blood glucose levels. Patient self-monitoring is important for people to prevent dangerous low blood glucose levels and to maintain control of their diabetes to prevent long-term complications. This short-term financial gain for PCTs may well result in more frequent hospital admissions, costly to treat long-term diabetic complications and a reduced quality of life for people with diabetes and their families.
- With implementation being carried out at local level by PCTs without ring-fenced funding, it is difficult to see that standards of care for people with diabetes will be equal and the postcode lottery of standards will continue.
- The funding and staffing consequences of the NSF need to be addressed urgently otherwise the NSF will have little effect and care will not improve.
- Without adequate diabetes specialist services, there is a real risk of substandard diabetes care in many districts.
Affordable accessible insulin for people in developing countries
In developing countries, there is a shortage of insulin and especially at times of emergencies. However, now the problem is no longer a simple matter of shortage of insulin supplies but shortage of affordable insulin.
The introduction of more expensive 'human' insulin by multi-national pharmaceutical companies and the discontinuation of cheaper animal insulins in developing countries has resulted in insulin being unaffordable for many poor families. The cost of insulin for one person can be 50% of a family's income and people are dying not for lack of insulin but for lack of affordable insulin.
Just one little girl in the Philippines:
She used animal insulin that was discontinued and replaced with significantly more expensive 'human' insulin. She had several brothers and sisters and her parents were forced to choose between paying for insulin for one child or feeding the other children. They had no choice and were forced to let the little girl with diabetes die - all for lack of affordable insulin.
IDDT campaigns to draw attention to the plight of people in the developing world and collects unwanted, in-date insulin to send to Insulin for Life, an Australian organisation that distributes diabetes supplies to the most needy.
No blood glucose meters available for blind and visually impaired people
People with diabetes need to regularly check their blood glucose levels at home in order to obtain blood glucose control. A small amount of blood is obtained from the fingers, placed on a strip which is then inserted into a small meter and a blood glucose reading is obtained.
Until a few years ago meters were available in the UK that had a synthesised voice system providing results that blind and visually impaired could hear. The manufacturers of these meters discontinued supply in the UK, apparently for 'lack of demand'. 'Talking meters' are available in the US and IDDT has lobbied to try to enable these meters to be available in the UK.
The campaign has succeeded and a 'talking' blood glucose meter is now available. It is called the SensoCard Plus meter and costs £149.00 and the test strips are available free on an NHS prescription.
Direct to Consumer Advertising of Drugs
IDDT is strongly opposed to any relaxation of the regulations that ban advertising of drugs to the public. We fully accept that there is a need for the public to have more information about medicines but we believe that this should be from independent sources and not the pharmaceutical industry who have a vested interest in the sales of medicines. Any relaxation in the laws to allow DTCA should be based on the evidence that demonstrates a clear health benefit and a lack of harm to the public and there is no such evidence.
In July 2001 the European Commission proposed changes in EU law to allow drug manufacturers to have 'disease awareness campaigns' for a 5 year period in 3 disease areas - AIDS, asthma and diabetes. This will allow pharmaceutical companies to directly supply information to patients and there are fears are that it will lead to direct to consumer advertising of drugs [DTCA]. It has been said that these proposals were as a result of demands from patient groups but the Commission has been unable to say which groups made the demand, why these 3 health areas were 'chosen' or what form the review at the end of the 5 years will take.
DTCA is likely to lead to increased expenditure on prescription drugs to the NHS. The evidence from the USA, one of the only two countries to allow DTCA, is that expenditure on drugs has increased greatly. From 1999 to 2000, 50 drugs were advertised and they accounted for a $9.94 billion increase in prescription drug spending.
IDDT has joined the campaign organised by Health Action International [HAI] opposing any relaxation in the law regarding direct to consumer advertising of drugs. For more information on the HAI campaign and our position statement visit http://www.haiweb.org/
Update October 23 2002- Europe rejects drug advertising
Euro-MPs overwhelmingly voted against the European Commissions proposal to relax the ban on drugs advertising direct to the public. In a vote of 494 to 42 the EU Parliament adopted an amendment that removed the Commissions proposal to allow the pharmaceutical industry to supply 'disease information' to people with asthma, diabetes and AIDS.
Supporters of the proposal have argued that 'disease information' from drug companies is not advertising and that patients need more information about the drugs that they are taking. No one would disagree with this sentiment but opponents of the proposal, including IDDT, believe that this information should come from independent sources and not the drug companies who have a vested interest in selling their products. They also believe that the wording 'disease information' was to disguise the underlying intent to move towards direct to consumer advertising of drugs.
The proposals will now go to the EU's Council of Ministers before returning to the EU Parliament again. Let us hope that the MEPs once again give a resounding no to the proposal.
Update June 2003
The Health Council has rejected Article 88 of the Directive on the Community Code relating to Medicinal Products for Human Use so preventing Direct to Consumer advertising of drugs. A success for the lobbying campaign!
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