Another cure for all known disease
Dr Crippen is confused. Again. It does not take much these days.
I awoke to the dulcet tones of John Humphreys on the Radio 4 Today programme proclaiming that a cure had been found for all known disease. Great, I will take a week off. Perhaps two.
Actually, the programme did not quite say that. It said that a research paper had shown that high doses of one of the new statins could reverse coronary artery disease. (the furring up of the coronary arteries that leads to heart attacks).
Only last week, Dr Crippen was reading in the British Journal of Cardiology that a very low dose of a statin would be enough to lower cholesterol levels quite significantly. Lowering cholesterol does not necessarily mean un-furring coronary arteries, but it seems reasonable to hope it might.
High dose? Low dose? Who knows.
Heigh-ho, here we go again.
Over breakfast, the morning’s Times was more restrained than Radio 4.
“One pill a day to beat heart disease.” (Read the full article here)
Perhaps just a week off work, then.
Hmm…Dr Crippen is not a cardiologist but he will tell you now, for free, that there is no one pill that will beat heart disease. I wish there were.
Nothing in medicine is as straightforward as this. For ten years or more doctors throughout the UK and USA spend hours persuading menopausal women to go on HRT. Women’s magazines poured out articles saying, “It is your right to have HRT, make sure your doctor prescribes it”.
One day, quite suddenly, the fashion changed.
The risk of breast cancer was a bit higher than we thought. The benefits in preventing heart disease were more imagined than real. There was the risk of blood clots. And so on and so forth. But the main thing that changed was not the science. It was fashion. There is nothing wrong with HRT. But the fashion now is to look for something more “natural” than HRT. Whatever “natural” means. Cow-dung is natural.
Have we got it right with statins?
Dr Crippen does not know. And this time, having had a Galileo-like experience with HRT, he is thinking very hard. He is questioning his whole knowledge base. I know that diuretics work, because I see people pee. I know blood pressure tablets work, because I see the blood pressure come down. I know antibiotics work, because I see the infection disappear. I have seen it all with my own eyes.
Do I know that statins work?
I do not know from personal experience. I know they bring down cholesterol levels. But do they reduce the incidence of heart disease? As secondary preventation, possibly. There is good evidence that they reduce the chances of a second heart attack. But primary prevention? In other words treating people who are well, or at least thought they were. Should we put statins in the tap water? There are many learned articles saying statins "work". But the usual definition of "work" revolves round reducing cholesterol levels. There is more to it than that. There were a lot of learned articles extolling the virtues of HRT. HRT research was often financed by the companies that make HRT. It was big business. Statins are potentially bigger business. We are looking at having most of the middle-aged population on these drugs. Who finances the statin research, I wonder?
At the end of this post, I have printed, in full, an editorial from the BMJ. It is a sensible coherent article. It is (of course!) written by two experienced family doctors. It asks a very simple question. "Do you belief that 90% or more of the middle aged people are ill and need medication?"
Look particularly at the conclusion.
There must be another side to the story? Are there potential problems with statins? Is there a downside to reducing cholesterol? Have a look at the Statin Alert site here
Do statins have side effects? Yes they do, and sometimes dangerous ones such as statin induced rhabdomyolosis. Dr Crippen has seen this happen twice. Have a look here.
Dr Crippen has been sent a collection of learned articles from a scientist in Australia, which challenge the whole thesis of statins. Many of them are convincing. I do not know how to make up my mind. I am on the front line. I will have to prescribe these drugs.
Who is right? I am not sure.
So what is Dr Crippen going to do for the moment? Nothing. I am good at that. I shall continue to prescribe statins for high risk people. I am not going to put the whole population on them. I need more information. So what should the customers do whilst we await further and better particulars?
Stop smoking. Lose weight. Take more exercise. Drink in strict moderation only. Relax more.
If you can do all that, you may put the statin industry out of business.
+++++++++++
BMJ 2005;330:1461-1462 (25 June), doi:10.1136/bmj.330.7506.1461
BMJ Editorial
Thresholds for normal blood pressure and serum cholesterol
Lower thresholds mean that 90% of people over 50 years are identified as patients.
For several years, disagreement has been growing in health services about ever lower thresholds for "normal" blood pressure and serum cholesterol, the most common biological risk factors for cardiovascular disease. This was most publicly expressed in 1999, when more than 800 doctors, pharmacists, and scientists from 42 countries signed an open letter to the then director general Gro Harlem Brundtland, outlining fears that the World Health Organization's new hypertension guidelines would result in increased use of antihypertensive drugs, at great expense and for little benefit.1 2 The simplistic linear structuring of many research questions and the extrapolation of research results over prolonged and unstudied time periods produce guidelines that make many doctors, and particularly general practitioners, feel uneasy about the high proportion of their patients who are being labelled as sick.
General practitioners are aware of the side effects of undue medicalisation and tend to question the external validity of randomised controlled trials under experimental conditions.3 They also have to consider the opportunity costs of intervening to alter the risk profile of large numbers of healthy people and the time and resources that this takes away from people who are currently sick.4 This does not mean that general practitioners question the efficacy or cost effectiveness of drug treatment for persons with overt atherosclerotic disease or at unquestionably high risk. The uneasiness is about primary prevention being conceived increasingly as a strategy implying individual risk identification and questionable labelling of disease.
The unrest provoked by the earlier WHO guidelines intensified with the publication of the latest European guidelines on prevention of cardiovascular disease in clinical practice in 2003.5 These suggest blood pressure above 140/90 mm Hg, with no age correction, and serum cholesterol of 5 mmol/l as the appropriate thresholds for intervention. The guidelines consider other risk factors and recommend a range of lifestyle changes alongside drug treatment but the bottom line is that the doctor is expected to inform the patient that these measurements mean that he or she is at increased cardiovascular risk regardless of the management proposed. In other words, a disease label is to be attached to the patient.
A paper by Getz et al outlines the results of applying these European guidelines to a total county population in Norway.6 The Nord Tröndelag health survey provides data on blood pressure and cholesterol for some 62 000 adults aged 20-79 in 1995-7. The figure from that paper, reproduced here, shows the proportion of each age group that would be identified as being at "increased risk." The proportions are disturbingly high even if only the recommended thresholds for blood pressure are applied. However, if the threshold for normal cholesterol is also applied half of the population would be considered at risk by the early age of 24 years. By the age of 49, this proportion rises to 90%. As much as 76% of the total adult population would be considered at "increased risk." The current life expectancy at birth in Norway is 78.9 years, making it one of the longest living populations ever.7 This compares with a life expectancy at birth in the United Kingdom of 78.1 years, which implies that even higher proportions may be found if the study is repeated in other populations.
Several issues need to be considered if such a large part of the population is to become a target for individual and lifelong risk interventions. Firstly, the potential benefits for treated patients become less at lower risk levels, indicated by increasing numbers needed to treat,8 whereas rates of side effects remain similar regardless of the level of risk. Secondly, evidence for the long term effectiveness of treatment is lacking, since data from short term studies are being extrapolated over the whole of the remaining lifespan. We have recently had sobering news regarding drugs that were thought to reduce cardiovascular events.9 Thirdly, the side effects of drugs tend to be under-reported as well as under-published, as with some of the cholesterol lowering drugs, and receptor blockers. Most randomised controlled trials are powered for efficacy end points and therefore grossly underpowered to detect anything more than common adverse events. Fourthly, we have very limited evidence on the effects of preventive drug treatment when several drugs are used to treat different risk factors simultaneously, and unfavourable drug interactions are an increasing problem. Fifthly, we have far too little understanding of the psychological impact and the wider health consequences of being labelled at risk.10 Finally, the huge cost of pharmaceutical interventions for an ever greater proportion of the population has the potential to destabilise publicly funded healthcare systems in even the richest nations. Such considerations are urgent as the guidelines from the European Society of Cardiology are in the process of being implemented and the quality and outcomes framework of the new general practitioner contract in the UK can be seen as part of this implementation.
Steinar Westin, general practitioner and professor of social medicine
Department of Public Health and General Practice, Norwegian University of Science and Technology, Medical Technical Research Centre, N-7489 Trondheim, Norway
(steinar.westin@ntnu.no)
Iona Heath, general practitioner, UK
++++++++++
Front page of the Times 14th March 2006 I awoke to the dulcet tones of John Humphreys on the Radio 4 Today programme proclaiming that a cure had been found for all known disease. Great, I will take a week off. Perhaps two.
Actually, the programme did not quite say that. It said that a research paper had shown that high doses of one of the new statins could reverse coronary artery disease. (the furring up of the coronary arteries that leads to heart attacks).
Only last week, Dr Crippen was reading in the British Journal of Cardiology that a very low dose of a statin would be enough to lower cholesterol levels quite significantly. Lowering cholesterol does not necessarily mean un-furring coronary arteries, but it seems reasonable to hope it might.
High dose? Low dose? Who knows.
Heigh-ho, here we go again.
Over breakfast, the morning’s Times was more restrained than Radio 4.
“One pill a day to beat heart disease.” (Read the full article here)
Perhaps just a week off work, then.
Hmm…Dr Crippen is not a cardiologist but he will tell you now, for free, that there is no one pill that will beat heart disease. I wish there were.
Nothing in medicine is as straightforward as this. For ten years or more doctors throughout the UK and USA spend hours persuading menopausal women to go on HRT. Women’s magazines poured out articles saying, “It is your right to have HRT, make sure your doctor prescribes it”.
One day, quite suddenly, the fashion changed.
The risk of breast cancer was a bit higher than we thought. The benefits in preventing heart disease were more imagined than real. There was the risk of blood clots. And so on and so forth. But the main thing that changed was not the science. It was fashion. There is nothing wrong with HRT. But the fashion now is to look for something more “natural” than HRT. Whatever “natural” means. Cow-dung is natural.
Have we got it right with statins?
Dr Crippen does not know. And this time, having had a Galileo-like experience with HRT, he is thinking very hard. He is questioning his whole knowledge base. I know that diuretics work, because I see people pee. I know blood pressure tablets work, because I see the blood pressure come down. I know antibiotics work, because I see the infection disappear. I have seen it all with my own eyes.
Do I know that statins work?
I do not know from personal experience. I know they bring down cholesterol levels. But do they reduce the incidence of heart disease? As secondary preventation, possibly. There is good evidence that they reduce the chances of a second heart attack. But primary prevention? In other words treating people who are well, or at least thought they were. Should we put statins in the tap water? There are many learned articles saying statins "work". But the usual definition of "work" revolves round reducing cholesterol levels. There is more to it than that. There were a lot of learned articles extolling the virtues of HRT. HRT research was often financed by the companies that make HRT. It was big business. Statins are potentially bigger business. We are looking at having most of the middle-aged population on these drugs. Who finances the statin research, I wonder?
At the end of this post, I have printed, in full, an editorial from the BMJ. It is a sensible coherent article. It is (of course!) written by two experienced family doctors. It asks a very simple question. "Do you belief that 90% or more of the middle aged people are ill and need medication?"
Look particularly at the conclusion.
There must be another side to the story? Are there potential problems with statins? Is there a downside to reducing cholesterol? Have a look at the Statin Alert site here
Do statins have side effects? Yes they do, and sometimes dangerous ones such as statin induced rhabdomyolosis. Dr Crippen has seen this happen twice. Have a look here.
Dr Crippen has been sent a collection of learned articles from a scientist in Australia, which challenge the whole thesis of statins. Many of them are convincing. I do not know how to make up my mind. I am on the front line. I will have to prescribe these drugs.
Who is right? I am not sure.
So what is Dr Crippen going to do for the moment? Nothing. I am good at that. I shall continue to prescribe statins for high risk people. I am not going to put the whole population on them. I need more information. So what should the customers do whilst we await further and better particulars?
Stop smoking. Lose weight. Take more exercise. Drink in strict moderation only. Relax more.
If you can do all that, you may put the statin industry out of business.
+++++++++++
BMJ 2005;330:1461-1462 (25 June), doi:10.1136/bmj.330.7506.1461
BMJ Editorial
Thresholds for normal blood pressure and serum cholesterol
Lower thresholds mean that 90% of people over 50 years are identified as patients.
For several years, disagreement has been growing in health services about ever lower thresholds for "normal" blood pressure and serum cholesterol, the most common biological risk factors for cardiovascular disease. This was most publicly expressed in 1999, when more than 800 doctors, pharmacists, and scientists from 42 countries signed an open letter to the then director general Gro Harlem Brundtland, outlining fears that the World Health Organization's new hypertension guidelines would result in increased use of antihypertensive drugs, at great expense and for little benefit.1 2 The simplistic linear structuring of many research questions and the extrapolation of research results over prolonged and unstudied time periods produce guidelines that make many doctors, and particularly general practitioners, feel uneasy about the high proportion of their patients who are being labelled as sick.
General practitioners are aware of the side effects of undue medicalisation and tend to question the external validity of randomised controlled trials under experimental conditions.3 They also have to consider the opportunity costs of intervening to alter the risk profile of large numbers of healthy people and the time and resources that this takes away from people who are currently sick.4 This does not mean that general practitioners question the efficacy or cost effectiveness of drug treatment for persons with overt atherosclerotic disease or at unquestionably high risk. The uneasiness is about primary prevention being conceived increasingly as a strategy implying individual risk identification and questionable labelling of disease.
The unrest provoked by the earlier WHO guidelines intensified with the publication of the latest European guidelines on prevention of cardiovascular disease in clinical practice in 2003.5 These suggest blood pressure above 140/90 mm Hg, with no age correction, and serum cholesterol of 5 mmol/l as the appropriate thresholds for intervention. The guidelines consider other risk factors and recommend a range of lifestyle changes alongside drug treatment but the bottom line is that the doctor is expected to inform the patient that these measurements mean that he or she is at increased cardiovascular risk regardless of the management proposed. In other words, a disease label is to be attached to the patient.
A paper by Getz et al outlines the results of applying these European guidelines to a total county population in Norway.6 The Nord Tröndelag health survey provides data on blood pressure and cholesterol for some 62 000 adults aged 20-79 in 1995-7. The figure from that paper, reproduced here, shows the proportion of each age group that would be identified as being at "increased risk." The proportions are disturbingly high even if only the recommended thresholds for blood pressure are applied. However, if the threshold for normal cholesterol is also applied half of the population would be considered at risk by the early age of 24 years. By the age of 49, this proportion rises to 90%. As much as 76% of the total adult population would be considered at "increased risk." The current life expectancy at birth in Norway is 78.9 years, making it one of the longest living populations ever.7 This compares with a life expectancy at birth in the United Kingdom of 78.1 years, which implies that even higher proportions may be found if the study is repeated in other populations.
Several issues need to be considered if such a large part of the population is to become a target for individual and lifelong risk interventions. Firstly, the potential benefits for treated patients become less at lower risk levels, indicated by increasing numbers needed to treat,8 whereas rates of side effects remain similar regardless of the level of risk. Secondly, evidence for the long term effectiveness of treatment is lacking, since data from short term studies are being extrapolated over the whole of the remaining lifespan. We have recently had sobering news regarding drugs that were thought to reduce cardiovascular events.9 Thirdly, the side effects of drugs tend to be under-reported as well as under-published, as with some of the cholesterol lowering drugs, and receptor blockers. Most randomised controlled trials are powered for efficacy end points and therefore grossly underpowered to detect anything more than common adverse events. Fourthly, we have very limited evidence on the effects of preventive drug treatment when several drugs are used to treat different risk factors simultaneously, and unfavourable drug interactions are an increasing problem. Fifthly, we have far too little understanding of the psychological impact and the wider health consequences of being labelled at risk.10 Finally, the huge cost of pharmaceutical interventions for an ever greater proportion of the population has the potential to destabilise publicly funded healthcare systems in even the richest nations. Such considerations are urgent as the guidelines from the European Society of Cardiology are in the process of being implemented and the quality and outcomes framework of the new general practitioner contract in the UK can be seen as part of this implementation.
Steinar Westin, general practitioner and professor of social medicine
Department of Public Health and General Practice, Norwegian University of Science and Technology, Medical Technical Research Centre, N-7489 Trondheim, Norway
(steinar.westin@ntnu.no)
Iona Heath, general practitioner, UK
++++++++++
2 Comments:
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