“Don’t bother me with facts, son. I’ve already made up my mind,” Foghorn Leghorn
NICE stands for the National Institute for Health and Care Excellence. It is a little known fact that it started life as the National Institute for Cost Effectiveness, before rapidly transforming into the National Institute for Clinical Effectiveness, then the National Institute for Clinical Excellence. As you can see it changed again, and now it should be NIHCE, but we do so like our acronyms also to be words. A life of simple puns is the life for me.
I was involved with NICE early on; I set up their first website for them, before being rather rudely elbowed aside. Naively, at the time, I thought the underlying concept of NICE was sound. An attempt to try to work out which medical interventions both worked, and also provided good value for money. This would bring rational thinking to the complex and difficult world where limited resources have to be rationed in some way.
Clearly, I knew that the Government of the time had basically set NICE up to act as a barrier to attacks by the public and a restless media. As everyone knows, the minute you refuse treatment to a young child for, say, cancer, the front pages of the newspapers light up in outrage. By getting NICE to say no, the Government could cower behind NICE’s decisions in relatively safety.
For, as we all know, even if a treatment costs two million, and the chances of success are one in a hundred, most people simply adopt the ‘pay anything, do anything, to save this child.’ mode. The counter argument, that I could use that two million to save fifty lives elsewhere rarely gets an airing. ‘A child is dying….’ Is an argument that usually shuts everyone else up pretty quickly. You can look a tad heartless, very rapidly.
In reality, the cowering didn’t last too long, for as some of you will know, the UK Government is now happy to pay almost unlimited monies into the cancer drugs fund. NICE says it is too expensive… don’t worry, ‘Our caring kind and compassionate Government is willing to pay anything for cancer drugs.’
Of course this rather destroys the entire point of NICE whose decisions are simply bypassed, and also makes it clear that people with cancer are considered far more valuable than anyone else. ‘Dying of motor neurone disease, or heart failure, or kidney disease…. Sorry mate, no money. We have spent it all on cancer drugs.’ The NHS, for a system so terrified of discrimination, against anyone, on the grounds of anything, it seems strange to positively discriminate in favour of people with one form of disease vs. another. Oxford entrance exam, discuss.
Don’t worry, it has long been clear that vote winning irrationality will crush evidence and judgement at every turn.
Anyway, I am getting far away from the point of why I set out to write this blog. NICE, like most organisations started out with a fairly clear aim. To look at medical interventions, then decide which ones provided enough benefit, at reasonable cost, to be funded. But it has grown and grown, or perhaps I could say that its role has metastasised.
It now has become – primarily – a guideline generating monster. Every couple of weeks NICE will drop six hundred pages of ‘how condition x must now be treated,’ onto the medical profession. Dense and verbose and boring and very, so very very, long, and then what?
Are they rules, must they be followed? This all becomes very opaque. Last year NICE decided (super short summary) that everyone with a risk of a cardiovascular event greater than 10%, over the next ten years, should be put on a statin. There was much debate, and the BMA (British Medical Association) voted – unanimously – that these guidelines should not be followed.
Did this make any difference? No. Did it make any difference that the Local Medical Committees (that represent all GPs) at their annual conference voted unanimously against these guideline? No. What are NICE doing about the fact that, at least, two thirds of GPs are completely ignoring these guidelines. Nothing…yet. No debate, no discussion. Nothing. They know that, over time, their guidelines will solidify into something that becomes, effectively, mandatory.
‘Our great and magnificent guidelines have been written, they shalt be distributed to the populace who shalt fall upon them with gratitude. This is the word of NICE.’ The huge stone gate to the citadel, that encloses the enclave of the wise men of NICE, then swings shut, until the next holy set of guidelines will be brought out, to magnificent fanfare. ‘All hail the NICE guidelines.’
Can you discuss anything with them? No, you cannot. A number of people, including me, wrote an open letter to NICE criticising the guidelines. NICE deigned to read our letter, they reviewed their own decision making, and they decreed that they could find no errors in what they had done. They were good enough to inform us of this fact citing the eminence of their ‘experts’ whose greatness and wisdom passes all mortal understanding.
Then what could we do? Nothing. NICE, you see, are both the prosecution and the defence council, the Judges and the Supreme Court all wrapped in one. There is no higher authority. There is no executive, no Ombudsman. The only authority that can review a NICE guideline is… NICE.
Which means that, for example, when a study comes out showing that long term statin use increases the risk of Parkinson’s disease by 230% (Relative Risk increase)1, NICE can feel free to totally ignore it. In fact, when confronted with this study they said it was ‘nonsense.’ An interesting response, I felt, before they had even seen it.
Ignoring NICE’s view that this study was nonsense, I did a little calculation based on this paper. It went something like this.
Parkinson’s disease affects about 1 in 250 people. It is not rare, but not that common. The NICE guidelines on statins mean that, at the very, very, least, 50% of people should take statins from the age of fifty, for the rest of their life [how many actually will is a moot point, but stay with me here].
If 50% of people take statins and the risk of Parkinson’s increases by 230% it follows that the 1/250 lifetime risk of developing Parkinson’s becomes an extra 2.3×1/250/2 = 0.0046.
IN short, the NICE guidelines will result in an extra 0.0046% of the population developing Parkinson’s. On the face of it, this may not seem like a massive problem. But the population of the UK is around sixty million, and if we multiply sixty million by 0.0046, we get 276,000. That is more than a quarter of a million people who will develop Parkinson’s disease who would not otherwise have done so.
Just from a purely economic basis, this would be hugely costly. Like all things in medicine, it is difficult to establish exactly how much it costs to look after a Parkinson’s patients, but in the UK it has been estimated as between £3,500 to £10,000 per year2. (Up to $100K in the US, I have read).
Multiply these two figures by 275,000 and we get a range of: £962,500,000 – £2,750,000,000/year ($1.443 – $4.12Bn/year)
Now you can argue these figures, and I am sure that NICE would – were they ever to engage in this debate. They will say that Parkinson’s is less common than this (I have seen both higher and lower estimates), they will argue the exact costs, they will bore you into submission with NPVs and suchlike.
You can argue all you like on the minutia, but if this paper is right, and I see no reason to suspect it is not, the NICE guidelines will inevitably result in hundreds of thousands of extra people developing Parkinson’s disease, at a cost of billions to the NHS. Leaving aside the added suffering and Disability Added Life Years (DALYs) this will bring.
Now this represents a massive and very major issue. If NICE were to take this research seriously, they would have to reconvene and review the evidence, and work out the ‘new’ costs and harms to patients, and perhaps they would have to reverse their guidance.
However, I know that they will not do this. They will just ignore this paper, and the implications thereof. I knew this would happen even before they started off by calling it nonsense, as you will remember they did that before they even read it. Even if they do actually read it, they will dismiss it as just one study to set against (my most hated of phrases) the ‘weight of evidence in favour of statins.’
The simple truth is that there is too much at stake here for NICE, and the entire spider’s web of interconnected reputations, and status, and opinion leaders, and money, for NICE to ever reconsider their guidance on statins. Facts and evidence are puny weapons in this battle.
Next week, dear reader, we shall examine the economic consequences of statins increasing the risk of type II diabetes by 46%. Get ready for some pretty gigantic figures. The zeros, they shall stretch as far as the eye can see.
1: Huang X et al: ‘Statins, Plasma cholesterol, and risk of Parkinson’s Disease. A Prospective study.’ J of Movement Disorders (epub ahead of print).