A heavy burden

The National Institute for Health and Clinical Excellence (NICE) changed from being interested only in clinical excellence to encompassing health excellence when it absorbed the work of the health promotion agency in April of this year.

It is established as a special health authority and is part of the NHS, with a board comprising a chair, non-executive directors, a CEO and a range of executive directors - much like any NHS board.

The chair and non-executives are appointed by ministerial patronage through the NHS Appointments Commission, whose members are also appointed by ministerial patronage.

Column inches
Never far from the headlines, in March NICE created a furore by reviewing its guidance on acetylcholinesterase (AchE) inhibitors for Alzheimer's dementia (AD).

Prior to recent guidance, and much to the relief of doctors, professionals, carers and patients, these products were recommended as acceptable therapies in AD, based on appropriate clinical assessment of each individual patient.

Voluntary groups like the Alzheimer's Society lobbied hard for these drugs to be available and welcomed the original NICE guidance. They are not best pleased by the recent decision to review the guidance and limit availability.

The Alzheimer's Society has formed an alliance with many powerful organisations, including the Royal College of Nursing, the Royal College of Psychiatrists, the Institute of Psychiatry and Help the Aged, to insist that people with Alzheimer's have full access to these drugs.

This alliance is encouraging people to write to their MPs to overturn the NICE review process and seems to be having considerable impact. NICE has received over 8,000 responses to its consultation document on this issue - something of a record.

Parliamentary questions since March suggest that the alliance created by the Alzheimer's Society is having an effect, and it is telling that prior to the election, Dr John Reid, then Health Secretary, was not exactly robust in his defence of the NICE decision.

This incident has brought into focus some of the dilemmas facing a body like NICE, which seeks to bring rationality to the complex processes involved in making choices as to where and how we spend NHS money.

Scientific approach
NICE rightly tries to take an evidence-based approach to its work, yet is hard science all that matters? This story also brings into focus the need to balance science with art and human experience, especially the experiences of front line clinical staff, carers and patients.

Despite the legitimate questions from NICE about the value of AchE inhibitors, there is ample anecdotal evidence from health professionals, carers and patients that these drugs are effective for many.

I have spoken to a significant number of doctors and nurses since March and they are unanimous that these drugs are crucial for patients with mild- to medium-AD, especially in the early stages of the disease. They are clear that the drugs inhibit deterioration markedly.

The Alzheimer's Society website is littered with quotes from carers and AD sufferers stating that these drugs have made a real difference to their lives. One says: Taking away treatments that give people hope would be a devastating blow. Another notes: If someone at NICE had AD they would want these drugs to be available.

All powerful and emotive stuff, evidence of sorts that NICE will need to consider other issues alongside the hard science, but where does it leave the NICE processes?

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Counting the cost
Cynics suggest that cost pressures determine NICE decisions and that the appraisal committee structure is being used to drag out a final decision to contain costs at the expense of a group of patients with a chronic condition and little power.

Despite this, the politics of this decision are high profile and high risk. Does a third term Labour government, spending record amounts on the NHS, want to be seen as the government that deprives the increasing grey vote of a drug that actually might slow the ravages of AD?

This story reminds us that health is political. We might have the best science available in a new area of disease management for now, but if the science does not chime with the experiences of clinicians and patients the political fall out is real.

All this leaves pharma companies in the midst of an unholy battle. No system of evaluation of health interventions is perfect, but NICE has a number of interesting mechanisms to take a balanced approach. NICE has a variety of stakeholder groups that it involves in its decisions, including patient, carer and key professional groups.

It also consults a wider citizens council, taking a broader public strand of opinion to inform its thinking. On the final decision of AchE inhibitors I have no doubt that NICE will seek these views, alongside the best available contemporary science.

Know your place
What is complex is the status of NICE as a part of the NHS. As a special health authority, under the direct impact of ministerial patronage, can NICE really claim to be independent?

It makes this claim on its website, but if you were the chair or a non-executive of NICE, and a minister or official leans on you because of political expediency, are you free to tell them to take a running jump?

I suspect not, and it is the structure and status of NICE that necessitates further discussion. Professor Kennedy, in his report into events at the Bristol Royal Infirmary looked closely at some of these issues and reminded us of the value of true independence, without let or undue hindrance from political and other pressures. As a result, Kennedy re-created the Commission for Health Improvement so that its successor body, the Healthcare Commission, reports directly to parliament on an annual basis and is free to say what it thinks.

The Healthcare Commission is not a special health authority and is not part of the NHS. The commissioners appointed to oversee the work programme are appointed via the privy council, with letters patent, making it much more free to comment with less interference.

It is easier for a minister to dispense with the services of a chair or non-executive of an NHS quango than it is to sack a commissioner able to report to parliament and appointed via the privy council. I am not suggesting that a commission is free from political insights or consider-ations; all public bodies need to be cognizant with such issues as they are ultimately not elected, but their level of independence in arriving at decisions is important in terms of public confidence.

Is it time, therefore, to suggest that NICE should break away from the NHS, be truly independent and called to report to parliament annually to give account of itself in the most public and democratic fashion? I believe there would be merit in such a change.

I have no doubt that all healthcare systems need a body like NICE to inform good clinical practice and ensure good decisions about relative priorities.

Many other nations have similar frameworks. The problem NICE faces is that it is always going to be under pressure from the vested interests of all kinds of stakeholders involving some pretty complex and often less than clear issues.

Pharma has a pretty ambivalent attitude towards NICE. Companies spend huge amounts of time and money submitting their various views to the body, and if they get a favourable outcome, NICE is loved; if they get a negative outcome, NICE is the enemy.

The same applies to other organisations in healthcare, including patient groups that want to influence NICE decisions. In a politically charged debate, as with AchE inhibitors, can NICE ever win?

I do not for one moment question the integrity of NICE board members; I am confident that they seek to be good public servants, executing their duties to the highest standards.

I simply express the view that they could do a more effective job as a truly independent commission, separate from the NHS and free from direct ministerial patronage.

Such change could do much to increase the confidence of all stakeholders involved in the work of NICE, but most importantly, the confidence of the public, whose interests it is there to serve primarily.

The Author
Ray Rowden is a health policy analyst and director of Mental Health International Development