NKF Campaigns Zone:
Dialysis

11^th October 2004

To:
Louise Martin
National Collaborating Centre for Chronic Conditions
Royal College of Physicians
11 St Andrews Place
Regents Park
London
NW1 4LE

Dear Ms Martin,

Stakeholder Submission for the anaemia management in chronic kidney disease guideline

The National Kidney Federation (NKF) would like you to accept this letter and the accompanying Appendix A and B as its submission to the above guideline.  The National Kidney Federation is the only UK wide patient charity run by renal patients for the benefit of renal patients and as such is accepted as the voice of the 37,500 renal (kidney) patients suffering end stage renal failure (ESRF). The Charity also represents the views of the carers of the patients.

The National Kidney Federation (NKF) has a working relationship with many pharmaceutical companies and this works to great advantage.  The nature of the support that an industry partner may give can vary, but essentially it usually comprises of an annual donation to assist with the costs of our core activity, office and staffing, plus assistance either practical or financial with a particular project that will assist kidney patients.

The NKF always likes to establish a close working relationship with these industry partners and in particular likes to encourage the relationships to be long term.  It is of prime importance to the NKF that its commercial neutrality is scrupulously preserved so that the interests on one company over another are not advanced by the NKF, or the interests of an industry partner are not put before the interests of kidney patients or carers.  The independence of the National Kidney Federation is one of its most important assets, and is one reason why Government is prepared to listen to the NKF over and above commercial bodies.  This independence will never be sacrificed in return for financial support.

The NKF wishes to place on record that amongst the current 15 Industry partners that support the work of the NKF are, Amgen, Ortho-Biotech (Janssen-Cilag),  Roche and Synermed.  These are all the companies known to the NKF  that have a commercial interest in the treatment of Anaemia, and by including all of them in our work the NKF ensures that no one company, or group of companies can exert, or try to exert any undue influence that might adversely affect the charities total independence from commercial considerations. We speak on behalf of the patients and carers – no one else.

In the early part of this year, we circulated 19,000 anaemia survey forms (Appendix A) to all our known patients via the charities own quarterly magazine “Kidney Life”. The replies (2,106) were returned to our headquarters by reply paid envelope and sent unopened to “Cardiff Research Consortium” for analysis. The Analysis (Appendix B) was then returned to the NKF in August this year (2004) followed by the bulk raw data.

The NKF has a wealth of experience of representing renal patients with anaemia, and together with the lessons learnt from the survey would like to bring before the review, the following matters for their consideration.

• There is no cure for renal disease. Without treatment patients die within days or weeks. Treatment consists of either dialysis or Transplant. Quality of Life for Dialysis patients is very poor. Transplanted patients take a cocktail of daily medication for the life of their transplant. Many patients return to Dialysis following a transplanted period. 66.5% or the respondents to the survey had been told they were anaemic.
• The addition of anaemia symptoms, to an already critical life situation, makes renal failure considerably more intolerable to both the patient and his carer, than is acceptable when treatment does exist. To undertake the aggressive dialysis treatment either daily, of three days per week, is a regime made very much worse if the patient is constantly exhausted and fatigued. Anaemia is completely debilitating to a renal patient. It can prevent a patient from continuing in work, it can cause relationship problems. A patients libido can suffer and fertility can be impaired. Anaemia can and does prevent renal patients from having the strength and resource to care for, interrelate to,  and look after their family members.
• The early detection and management of Anaemia, can prevent many patients from progressing to “End Stage Renal failure”. Patients with a Glomerular Filtration Rate (GFR) of less than 60ml/min must be found, as according to the recent “Medicines Management” document they may represent 4% of the population and many of those, will be anaemic. It is vital that potential ESRF patients are identified before they progress to kidney Failure. Many such patients will be anaemic, and by identifying them, then managing their anaemia, this progression to kidney failure can be slowed down or prevented, thus saving the cost of ESRF to the NHS and transforming the lives of those patients for the better. Currently these patients are being missed and left untreated.
• The NKF remains deeply concerned at the current lack of any “equality of access” to anaemia treatment. This is a post-code lottery of the worst kind as reference to our survey - (Appendix B) clearly shows in questions 9-11 inclusive. The cost of treatment was the cause for refusal in 70.3% of the respondents who were refused (64 out of 78 patients). Please remember that our survey only reports the findings amongst 2,106 patients. The ESRF renal population is actually 37,500 patients. The following replies have been extracted from the survey graph that appears on page 8.

  50% My GP would not pay for it

  20% The Hospital could not pay for it

The NKF is aware that neither GP’s or Hospitals want anaemia treatment paid for from their own budgets and that patients frequently find that this reluctance often leads to confusion and to the absence of treatment. GP’s do tell patients that they are not prepared to prescribe anaemia treatment for a renal patient who’s condition is managed by a renal specialist at hospital. Hospitals will tell the patient the exact reverse. These are administrative problems that cause great harm. All renal units and all GP’s should abide by a code of practice contained in your guidelines which results in all identified anaemic renal patients receiving treatment.

• A Dialysis patient hopes for a Transplant, it is the only way that quality of life can be restored, yet a Transplant is very much less likely if antibodies are present as a result of treating anaemia by blood transfusion. This problem does not occur if the anaemia is treated by iron or EPO or both. If the Anaemia is left untreated heart failure (Left Ventricular Hypertrophy) can result, and such additional complications can also rule out a potential transplant.
• A major cause of death in a renal patient is heart failure caused by cardiovascular complications. Heart specialists regard the treatment of anaemia as crucial in all their patients irrespective of kidney disease.
• Renal Disease is recognised as being in one of five stages as the disease deteriorates. Patients in the later stage, receiving dialysis, benefit from effective anaemia treatment provided by their units, however much of the damage done to the heart occurs during stages 1 to 4 and it is thought that 75% of new dialysis patients already have Left Ventricular Hypertrophy. The inescapable logic must dictate that anaemia is identified early on and managed in the early stages of renal disease.
• Most renal patients rely heavily on the support of their carer – usually a family member or spouse. This is a very daunting responsibility and many carers find that they themselves need support in order to cope with the unrelenting needs of a renal patient. The NKF regards renal carers as its members in the same way as renal patients – we represent both. If anaemia in a renal patient is allowed to go untreated, then as well as all the complications of kidney failure, the patient themselves suffer Tiredness, weakness, shortness of breath, palpitations, headaches, poor sleep patterns and sexual problems. These problems make the role undertaken by the carer much, much worse – their renal partner cannot get out of bed, can’t climb stairs, can’t take a bath, can’t exercise and cannot undertake work – in short leaving the entire burden on the carer.
• It is very clear from the graphs shown on page 20 and 21 (Questions 21 and 22) that treatment of anaemia is effective and that Haemoglobin levels do rise significantly. Patients regarded anaemia treatment as “the magic treatment that makes living bearable and worthwhile again ”

The National Kidney Federation considered very carefully how it might make a submission to you that would be regarded by you as the type of information that can be considered. We are a patient group, not experts in the provision of medicine or treatment, we do not have access to “sufficiently rigorous research methods” or huge databases of historical information. What we do have however are thousands upon thousands of patients who are on the receiving end of the treatment under review. We decided to ask them what was going on, and to ask them to make their voices heard in our survey – we felt that by these means we would be able to show that this is not just anecdotal evidence, but two thousand real life experiences that would paint you an accurate picture once assimilated and analysed.

This survey has been a very large undertaking for us – we are a national, but small charity, with limited resources. We do regard the survey as very worthwhile, and worthy of your detailed consideration.

If you require oral evidence from patients to support any part of our submission, then we are happy to arrange this.

Yours sincerely

Timothy F Statham OBE

NKF Chief Executive

Click here to view the results of the NKF Patient Anaemia Survey (NB This link will take you to another webpage on this Web Site with more information on how to view the results)