Post by Deanne Jenkyns on Aug 28, 2007 19:49:19 GMT 1
Lots of people ask me who NICE are and what they do...well this article sums it up perfectly!
Sentenced to death by NICE
By DR SARAH JARVIS
It's the body that decides which drugs are allowed on the NHS. But in this blistering attack, a leading GP argues the organisation set up to improve care is obsessed by costs, discriminates against the elderly - and ultimately is killing patients:
Recently I was left feeling furious and frustrated after a visit from a patient called Peter. He'd just had a serious heart attack and my job as a GP was to reduce his very high risk of having another.
I knew what the latest research told me was the best way, but I had just basically been forbidden to use it by an official email from the Department of Health.
Instructions about what treatments I can and can't give are issued by a government body called NICE (National Institute for Health and Clinical Excellence).
What is happening with Peter is just one example of what sometimes goes wrong with NICE - a body set up with the laudable aim of helping doctors and improving care for patients but which is now, in some cases, preventing doctors from treating to the best of their ability, and instead is putting thousands of patients' lives at risk.
The original intention was that NICE would eliminate the postcode lottery in prescribing, but in many areas it has made it worse. It was also supposed to speed up the rate at which new treatments were made available to patients. Instead, it is acting as a very effective brake.
Even worse, there is evidence that NICE's decisions are not always impartial.
On my desk I have a set of guidelines on how best to reduce the risk of a second heart attack in patients such as Peter. These were drawn up by the Joint British Societies (JBS) - the top professional organisations involved in heart disease.
JBS members are experts in the field who understand all the research and its implications, and what they say is that I should use statin drugs to bring down Peter's overall cholesterol level to 4 mi llimoles (mmols) and his LDL - the 'bad' cholesterol - to 2 mmols.
So what does NICE recommend? It tells me that my targets should be 5 mmols and 3 mmols. Now, that may not sound like a big difference, but a very well reviewed paper in the Lancet has shown that for every 1mmol you bring down LDL cholesterol, you get a 23 per cent reduction in the risk of another attack. In fact, the NICE guidelines are six years out of date: the European ones were changed three years ago.
Even so, the email that GPs have been sent makes it clear that these are the ones I have to follow until NICE issues a new set more than a year from now. If I treated all my women heart attack patients according to the JBS rather than the NICE guidelines for six years, one out of every 12 would be prevented from having a second heart attack.
Instead, I am expected to follow the NICE guidelines. That makes a difference to me and to Peter because the local Primary Care Trust (PCT) makes it really difficult to get the stronger drugs needed to bring his cholesterol down to the safer level. With some drugs, they even ban them outright by refusing to fund them.
Working to these outdated NICE guidelines means that a significant number of people are going to have heart attacks that could be prevented and thousands of lives lost.
When NICE was launched seven years ago, I thought it was a great idea. No doctor can keep up with all the latest research, and getting regular updates on what it showed could obviously be very valuable.
What I hadn't appreciated was the importance of who exactly was doing the updating. It's true that some of its guidelines on how to treat particular conditions can be very helpful, but when they're not, the results can be disastrous. This is perhaps not surprising when you look at who sits on some of its committees.
Recently, one was set up to consider a new cancer drug. Many of its members were health economists, others specialised in diabetes, morbid anatomy and community practice - but not one was a cancer specialist. Are these really the best people to advise on cancer drugs?
What's worse is that once committees with their limited expertise have made a recommendation, they seem very reluctant to listen to evidence challenging it.
When I attended an appeal against a new set of guidelines for a heart drug, I was absolutely shocked: it was the most inequitable process I had ever come across.
While the chairman of the original committee which had set the guidelines was given endless leeway to veer off at tangents, others who tried to question the decisions were told we'd spent enough time on that topic and had to move on.
NICE says that if the committees were just made up of cancer experts, too many would have links to the drug companies and be biased in a drug's favour.
They also argue that an important part of their work is to say if a drug is worth the money - and for that they need economists. It's true that someone has to decide if a drug is value for money, and that's a difficult job. But the way NICE is going about it at the moment seems aimed more at cost-cutting than at helping doctors do the best for their patients.
The decision is made using a calculation known as a QALY (cost per Quality Adjusted Life Year).
It's a way of putting a price tag not just on the extra years you gain from a treatment but also how enjoyable they are. This involves tricky calculations. Some things such as hospital admissions are easy to measure; but more intangible things, such as stress, are not.
NICE regularly presents its QALY calculations as absolute. This is worth it - that isn't. But it might be more accurate to say that NICE chooses the cut-off point depending on whether or not it is in favour of a drug.
So there are cases of drugs that have been approved with a QALY cost of £30,000 and others refused with one of £22,000. Drugs do have to be rationed, but it is not ethical to do it by massaging the figures.
Perhaps we will finally learn more about just how NICE makes its QALY calculations if the threatened legal challenge to NICE over the refusal to approve Alzheimer drugs takes place. If NICE is to retain its credibility, the process for approving drugs must become much more transparent.
Instead, the only thing that's clear is that NICE treats different drugs differently. Why does it do so?
It's hard to escape the conclusion that there is a bias against treating elderly people properly simply because - and I know this sounds harsh - they are an increasing burden on the taxpayer.
This came out very clearly in its guidance on how high the risk of heart disease had to be in someone over 75 before it was worth giving statins. NICE initially concluded that, as a rule, not even those with a risk of over 30 per cent should get statin drugs.
They then had to backtrack furiously when they received a wealth of evidence showing that treating over 75s with statins was just as effective as treating younger people.
Either the committee didn't do its job properly or this was a deliberate attempt to blind GPs with statistics and get them to treat fewer old people.
But the use of NICE guidelines - which, remember, were supposed to be something to help doctors make the best decisions for their patients - as a form of hidden rationing isn't limited to the elderly. Cancer patients and others are also caught in a trap that it has created together with the PCTs.
Let me give you an example of how it works. In theory, once a drug has been licensed in the UK any doctor can use it. But, thanks to NICE, this is not what happens. Instead, many PCTs refuse to fund certain drugs until they've been approved by NICE.
But in the case of some drugs (including, until they recently started being 'fast-tracked', cancer drugs) the wait between licensing and NICE approval averages over two years and can be as long as four years. Contrast that with one of the reasons given for establishing NICE: 'We are sometimes too slow to introduce effective new treatments.'
In fact, the PCTs are not allowed to block payment in this way and I have a letter from Health Secretary Patricia Hewitt saying that.
But you have to fight for it. I have done that for my patients over drugs where I know the evidence base well, but many GPs don't specialise and many are not as noisy as I am. So people who could be getting help aren't because of this backdoor rationing.
Quite apart from preventing us from doing our job properly, this introduces a new form of postcode lottery. And what did NICE's founding document say? ' Postcode lotteries will become a thing of the past.'
Today, depending on where you live, a new drug might be funded as soon as it becomes available, you might have to wait years for a NICE approval, or you could get it at some in-between date if your PCT was prepared to accept the recommendation of the local cancer network.
At the moment, it looks as though patients in England won't be able to have the lung cancer drug Tarceva, even though it is available in Scotland.
It is quite wrong for NICE with its sometimes flawed committee system to present itself as the only fount of medical wisdom. When there is ample, high quality evidence from an unbiased source of the best way to treat a patient, NICE should make this the official guideline.
Note 'guideline' not instruction. I am a GP with ten years of clinical training and 16 years' experience: that should be enough for me to be allowed to make decisions about what is best for my own patients in terms of treatment.
I am perfectly happy to be taken to task on my prescribing and I would vigorously defend it on the basis of evidence. I welcome guidelines in areas I'm not up to speed on - but where I do have clinical expertise, I should be free to exercise it.
What is not acceptable is that I should be told what I can do on the basis of outdated information. The fee for this article has been donated to Heart UK. Dr Jarvis is writing in a personal capacity.
Sentenced to death by NICE
By DR SARAH JARVIS
It's the body that decides which drugs are allowed on the NHS. But in this blistering attack, a leading GP argues the organisation set up to improve care is obsessed by costs, discriminates against the elderly - and ultimately is killing patients:
Recently I was left feeling furious and frustrated after a visit from a patient called Peter. He'd just had a serious heart attack and my job as a GP was to reduce his very high risk of having another.
I knew what the latest research told me was the best way, but I had just basically been forbidden to use it by an official email from the Department of Health.
Instructions about what treatments I can and can't give are issued by a government body called NICE (National Institute for Health and Clinical Excellence).
What is happening with Peter is just one example of what sometimes goes wrong with NICE - a body set up with the laudable aim of helping doctors and improving care for patients but which is now, in some cases, preventing doctors from treating to the best of their ability, and instead is putting thousands of patients' lives at risk.
The original intention was that NICE would eliminate the postcode lottery in prescribing, but in many areas it has made it worse. It was also supposed to speed up the rate at which new treatments were made available to patients. Instead, it is acting as a very effective brake.
Even worse, there is evidence that NICE's decisions are not always impartial.
On my desk I have a set of guidelines on how best to reduce the risk of a second heart attack in patients such as Peter. These were drawn up by the Joint British Societies (JBS) - the top professional organisations involved in heart disease.
JBS members are experts in the field who understand all the research and its implications, and what they say is that I should use statin drugs to bring down Peter's overall cholesterol level to 4 mi llimoles (mmols) and his LDL - the 'bad' cholesterol - to 2 mmols.
So what does NICE recommend? It tells me that my targets should be 5 mmols and 3 mmols. Now, that may not sound like a big difference, but a very well reviewed paper in the Lancet has shown that for every 1mmol you bring down LDL cholesterol, you get a 23 per cent reduction in the risk of another attack. In fact, the NICE guidelines are six years out of date: the European ones were changed three years ago.
Even so, the email that GPs have been sent makes it clear that these are the ones I have to follow until NICE issues a new set more than a year from now. If I treated all my women heart attack patients according to the JBS rather than the NICE guidelines for six years, one out of every 12 would be prevented from having a second heart attack.
Instead, I am expected to follow the NICE guidelines. That makes a difference to me and to Peter because the local Primary Care Trust (PCT) makes it really difficult to get the stronger drugs needed to bring his cholesterol down to the safer level. With some drugs, they even ban them outright by refusing to fund them.
Working to these outdated NICE guidelines means that a significant number of people are going to have heart attacks that could be prevented and thousands of lives lost.
When NICE was launched seven years ago, I thought it was a great idea. No doctor can keep up with all the latest research, and getting regular updates on what it showed could obviously be very valuable.
What I hadn't appreciated was the importance of who exactly was doing the updating. It's true that some of its guidelines on how to treat particular conditions can be very helpful, but when they're not, the results can be disastrous. This is perhaps not surprising when you look at who sits on some of its committees.
Recently, one was set up to consider a new cancer drug. Many of its members were health economists, others specialised in diabetes, morbid anatomy and community practice - but not one was a cancer specialist. Are these really the best people to advise on cancer drugs?
What's worse is that once committees with their limited expertise have made a recommendation, they seem very reluctant to listen to evidence challenging it.
When I attended an appeal against a new set of guidelines for a heart drug, I was absolutely shocked: it was the most inequitable process I had ever come across.
While the chairman of the original committee which had set the guidelines was given endless leeway to veer off at tangents, others who tried to question the decisions were told we'd spent enough time on that topic and had to move on.
NICE says that if the committees were just made up of cancer experts, too many would have links to the drug companies and be biased in a drug's favour.
They also argue that an important part of their work is to say if a drug is worth the money - and for that they need economists. It's true that someone has to decide if a drug is value for money, and that's a difficult job. But the way NICE is going about it at the moment seems aimed more at cost-cutting than at helping doctors do the best for their patients.
The decision is made using a calculation known as a QALY (cost per Quality Adjusted Life Year).
It's a way of putting a price tag not just on the extra years you gain from a treatment but also how enjoyable they are. This involves tricky calculations. Some things such as hospital admissions are easy to measure; but more intangible things, such as stress, are not.
NICE regularly presents its QALY calculations as absolute. This is worth it - that isn't. But it might be more accurate to say that NICE chooses the cut-off point depending on whether or not it is in favour of a drug.
So there are cases of drugs that have been approved with a QALY cost of £30,000 and others refused with one of £22,000. Drugs do have to be rationed, but it is not ethical to do it by massaging the figures.
Perhaps we will finally learn more about just how NICE makes its QALY calculations if the threatened legal challenge to NICE over the refusal to approve Alzheimer drugs takes place. If NICE is to retain its credibility, the process for approving drugs must become much more transparent.
Instead, the only thing that's clear is that NICE treats different drugs differently. Why does it do so?
It's hard to escape the conclusion that there is a bias against treating elderly people properly simply because - and I know this sounds harsh - they are an increasing burden on the taxpayer.
This came out very clearly in its guidance on how high the risk of heart disease had to be in someone over 75 before it was worth giving statins. NICE initially concluded that, as a rule, not even those with a risk of over 30 per cent should get statin drugs.
They then had to backtrack furiously when they received a wealth of evidence showing that treating over 75s with statins was just as effective as treating younger people.
Either the committee didn't do its job properly or this was a deliberate attempt to blind GPs with statistics and get them to treat fewer old people.
But the use of NICE guidelines - which, remember, were supposed to be something to help doctors make the best decisions for their patients - as a form of hidden rationing isn't limited to the elderly. Cancer patients and others are also caught in a trap that it has created together with the PCTs.
Let me give you an example of how it works. In theory, once a drug has been licensed in the UK any doctor can use it. But, thanks to NICE, this is not what happens. Instead, many PCTs refuse to fund certain drugs until they've been approved by NICE.
But in the case of some drugs (including, until they recently started being 'fast-tracked', cancer drugs) the wait between licensing and NICE approval averages over two years and can be as long as four years. Contrast that with one of the reasons given for establishing NICE: 'We are sometimes too slow to introduce effective new treatments.'
In fact, the PCTs are not allowed to block payment in this way and I have a letter from Health Secretary Patricia Hewitt saying that.
But you have to fight for it. I have done that for my patients over drugs where I know the evidence base well, but many GPs don't specialise and many are not as noisy as I am. So people who could be getting help aren't because of this backdoor rationing.
Quite apart from preventing us from doing our job properly, this introduces a new form of postcode lottery. And what did NICE's founding document say? ' Postcode lotteries will become a thing of the past.'
Today, depending on where you live, a new drug might be funded as soon as it becomes available, you might have to wait years for a NICE approval, or you could get it at some in-between date if your PCT was prepared to accept the recommendation of the local cancer network.
At the moment, it looks as though patients in England won't be able to have the lung cancer drug Tarceva, even though it is available in Scotland.
It is quite wrong for NICE with its sometimes flawed committee system to present itself as the only fount of medical wisdom. When there is ample, high quality evidence from an unbiased source of the best way to treat a patient, NICE should make this the official guideline.
Note 'guideline' not instruction. I am a GP with ten years of clinical training and 16 years' experience: that should be enough for me to be allowed to make decisions about what is best for my own patients in terms of treatment.
I am perfectly happy to be taken to task on my prescribing and I would vigorously defend it on the basis of evidence. I welcome guidelines in areas I'm not up to speed on - but where I do have clinical expertise, I should be free to exercise it.
What is not acceptable is that I should be told what I can do on the basis of outdated information. The fee for this article has been donated to Heart UK. Dr Jarvis is writing in a personal capacity.
LC charity Ball
