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EDITORIALS: Steinar Westin and Iona Heath Thresholds for normal blood pressure and serum cholesterol BMJ 2005; 330: 1461-1462 [Full text]

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Rapid Responses published:

we know enough to take action on cardiovascular disease

Raymond A Meleady   (24 June 2005)

A timely warning

Malcolm e Kendrick   (24 June 2005)

The risks of low cholesterol

Eddie Vos   (24 June 2005)

Treatment of hypertension

Elliot F Epstein   (26 June 2005)

Re: we know enough to take action on cardiovascular disease

Stevie M Gamble   (26 June 2005)

Treatment for all?

Michael Schachter   (26 June 2005)

Deep down the medical science is very shallow

BM Hegde   (27 June 2005)

Iatrogenic mass hypochondria

Shashikiran Umakanth   (27 June 2005)

Proportion of people eligible for BP and cholesterol lowering treatment greatly exaggerated

D Graham Mackenzie, John F Forbes, Philip Rutledge   (27 June 2005)

Medicalisation is not a synonym for drug treatment

Linn Getz, Johann Agust Sigurdsson, Irene Hetlevik   (30 June 2005)

The root of the problem...

James Penston   (1 July 2005)

Refreshingly objective physicians

John P Heptonstall   (2 July 2005)

A threshold too far?

Jean P Fisher   (2 July 2005)

Primary prevention of cardiovascular disease

B Kirkup   (5 July 2005)

A blinkered approach to the prevention of cardiovascular disease

Graham A MacGregor, Feng J. He   (8 July 2005)

Re: Editorial: Thresholds for normal blood pressure and serum cholesterol. BMJ 2005;330:1461-2

Prof Ian M Graham, Prof Guy de Backer, Prof Kalevi Pyörälä   (12 July 2005)

What about our patients' views?

Geraint V Jones   (3 August 2005)

The combined risk estimate does not solve the problem

Linn Getz   (17 August 2005)

What to do in routine primary care? – isn’t it screening?

Franz Piribauer, MD, MPH   (17 August 2005)

Is it Ethical to Medicalise Normality

Tim M Reynolds   (18 August 2005)

Diseases and risk factors

Anthony S Wierzbicki   (23 August 2005)

Just too smart for our britches?

Hilary Butler   (30 June 2007)

we know enough to take action on cardiovascular disease 24 June 2005
Raymond A Meleady, Consultant Cardiologist Queen Elizabeth Hospital, Gateshead, NE9 6SX Send response to journal: Re: we know enough to take action on cardiovascular disease	Dear Editor I read with interest the paper by Westin and Heath: BMJ 2005;330:1461-62 but found I had to check the date twice. The same arguments were marshalled over 20 years ago when I was a medical student(labelling patients as being ill when risk factors are identified) and a decade later when, for a time, it led to paralysis in reducing serum cholesterol(insufficient evidence of benefit and high cost to society). The target on this occasion is the European Guidelines on cardiovascular disease prevention in clinical practice(DeBacker et al. Eur Heart J 2003;24:1601-10 . The raison d'etre of these guidelines was the poor uptake of evidence based therapies as indicated by audit data in the EUROASPIRE studies(Eur Heart J. 2001 Apr;22(7):554-72). Westin and Heath suggest that we do not have sufficient long term evidence of benefit. It is now 10 years since the 4S(Pedersen et al Lancet 1994;334:1383-89) and WOSCOPS studies(Shepherd et al. N Engl J Med 1995;333:1301-07). There are data relating to outcomes in over 30,00 patients exposed to statins. Many of us believe that we have sufficient evidence to advise people (who are not yet "patients")based on the concept of total risk, a concept based on the interaction of (even modest levels of) cardiovascular risk factors. I am, of course, aware that I will probably never have all of the information I would desire before giving such advice and that it is more difficult to demonstrate evidence of benefit in low risk subjects. However, waiting for the subject to become a patient and assuming survival of the cardiovascular event seems an extraordinarily expensve way for a society to manage an epidemic. Westin and Heath argue that we should await larger studies sufficiently powered to detect the uncommon side effects of medications being recommended. However, how could such a study ever be undertaken i.e. to look for something which we are not sure exists. Surely it is the function of registry ("real life" as opposed to idealised randomised controlled trials) data to detect such unwanted effects. In any event, the authors claim that GP's do not have faith in randomised controlled trials. With regard to always waiting for absolute proof, should Snow have waited for the identification of the cholera bacillus before turning off the Broad Street pump?(On the mode of communication of cholera. Churchill, London 1855) Apart from the unreferenced statement that "unfavourable drug interactions are increasing," what evidence do Westin and Heath have for their concern over the psychological impact on the individual of being labelled? My own experience tells me that those who have sustained a myocardial infarct and who survive to discuss the matter with me might have appreciated earlier identification and treatment of their risk factors. If Westin and Heath are correct, we should abandon the current hand-washing programme in hospitals for fear we induce mass neurosis about micro-organisms? Yours sincerely Raymond Meleady MD Competing interests: None declared
A timely warning 24 June 2005
Malcolm e Kendrick, Medical Director Adelphi Lifelong Learning Adelphi Lifelong Learning, Adelphi Mill Bollington SK10 5JB Send response to journal: Re: A timely warning	The authors must be commended on their timely paper. It is inconceivable that 90% of any population can be considered ill enough to be placed on drugs for the rest of their lives. This is the antithesis of medicine and the adage 'first do no harm.' By placing untold millions of people on drugs we are quite definately doing harm. Are we doing any good? The only studies on statins that have shown reduction in overall mortality are the secondary prevention studies such as 4S and HPS. Even in these studies there was no reduction in overall mortality in women. A result dismissed as a statistical aberration. Furthermore, in none of the primary prevention studies on statins has there been any reduction in overall mortality in men, or women. In short, for all women, and the vast majority of men, taking a statin may alter what is written on a death certificate, but it will not change the date. With regard to blood pressure lowering, there have been ninteen major trials comparing active compound to placebo. In total, this represents 67,768 years of treatment. At the end of all trials 150 more patients on antihypertensives were alive, than in the placebo group. Each patient gaining, on average, six months of extra life. This adds up to a grand total of 75 extra life years gained from 67,758 years of treatment. If this figure is extrapolated, the results of the antihypertensive trials mean that if you take a blood pressure lowering tablet for thirty years, you may expect to live for 12 more days. About the time taken to swallow the tablets, probably. Advising millions of people to take drugs for such minuscule gain, and huge societal and economic costs, is medical madness at the very extreme boundaries of human behaviour. Competing interests: A member of the International Network of Cholesterol Skeptics (www.thincs.org)
The risks of low cholesterol 24 June 2005
Eddie Vos, maintains health-heart.org Sutton (Qc) Canada J0E 2K0 Send response to journal: Re: The risks of low cholesterol	Dr. Westin's editorial regarding 'normal cholesterol' having a prescribing trip-point point at 5 mmol/L, as per European cardiology guidelines (his ref. 5) and a potential resulting mass drug use is sobering as well as refreshing. Moreover, prescribers and patients may find comfort and reflection in the recent Austrian Vorarlberg population study covering 15 years, 149,650 subjects and 454,448 examinations) (1): "In men, across the entire age range, although of borderline significance under the age of 50, and in women from the age of 50 onward only, low cholesterol [sic] was significantly [positively] associated with all-cause mortality, showing significant associations with death through cancer, liver diseases, and mental diseases." Interestingly, regarding the 24,128 women over age 50 and 1924 deaths, those in the lowest quartile for cholesterol (<4.7 mmol/L or <184 mg/dL) had the same ~60% increased risk of death as those smoking (table 4B in ref. 1). 1. Ulmer H, Kelleher C, Diem G, Concin H. Why Eve is not Adam: prospective follow-up in 149650 women and men of cholesterol and other risk factors related to cardiovascular and all-cause mortality. J Womens Health 2004 Jan-Feb;13(1):41-53. Medline: 15006277 Competing interests: None declared
Treatment of hypertension 26 June 2005
Elliot F Epstein, Consultant Physician Manor Hospital WS2 9PS Send response to journal: Re: Treatment of hypertension	Westin and Heath highlight potential difficulties in treating hypertension for a large proportion of the population (1). The main benefit of control of hypertension is to prevent potentially devastating conditions, notably stroke. I believe that a health care professional, aware of the benefits of rigorous control of hypertension (2), may be concerned, and even frightened, if his or her arterial blood pressure was noted to be greater than 140/90 and no treatment was on offer. Such concern should clearly extend to the population at large. Rather than discuss low risk groups that may qualify for under- treatment, it may be more productive to examine strategies to improve cost -effectiveness of blood pressure reduction for a large number of people. For example, allied health care professionals may be trained to treat hypertension with care pathways and protocols to relieve burden on General Practitioners. (1) Westin S, Heath I. Thresholds for normal blood pressure and serum cholesterol. BMJ. 2005; 330(7506): 1461-2. (2) Hansson L, Zanchetti A, Carruthers SG, Dahlof B, et al. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. HOT Study Group. Lancet. 1998; 351(9118): 1755-62 Competing interests: None declared
Re: we know enough to take action on cardiovascular disease 26 June 2005
Stevie M Gamble, retired HMIT EC2Y 8BL Send response to journal: Re: Re: we know enough to take action on cardiovascular disease	Raymond Meleady, Consultant Cardiologist, arguing in support of mass- medication of people who may develop heart problems at some time in the future, suggests in his Rapid Response of 24th June ‘If Westin and Heath are correct, we should abandon the current hand- washing programme in hospitals for fear we induce mass neurosis about micro-organisms?’ The answer is pretty obvious. We won’t need to; there won’t be any NHS hospitals to have hand-washing programmes in. They will all have been closed down to provide the funding for General Practitioners to screen and treat the entire population for potential heart problems… Incidentally, I do appreciate that cardiologists cannot be expected to possess the financial expertise of Her Majesty’s Inspectors of Taxes, but even the most fiscally illiterate of individuals should be able to grasp that there is not a bottomless pit of money available. The generality of taxpayers foots the bill, and those taxpayers have the right to expect that those arguing for a course of action put all of their cards on the table face up. Raymond Meleady can start by telling us which departments he thinks should be closed down first to pay for his proposals. Stevie Gamble Competing interests: None declared
Treatment for all? 26 June 2005
Michael Schachter, Senior lecturer in Clinical Pharmacology, Imperial College London St Mary's Hospital W2 1NY Send response to journal: Re: Treatment for all?	This article raises several interesting issues. The evidence for lipid-lowwering treatment, in particular, is strong for patients following myocardial infarction. This is not disputed by the authors as I understand it, although Dr Meleady seems to interpret this differently. What is at issue is so called primary prevention. Here we are in the crossfire bewteen guidelines. On the one hand we are set the thresholds cited in this article. On the other there are recommendations for intervention at a specific level of calculated global cardiovascular risk, usually 15 or 20% over 10 years. It is likely that most of the people who reach both of the individual thresholds would still fall of this level of cardiovascular risk if they were non-smokers and not diabetic. The decision on the risk level that requires intervention is at least as much economic as clinica. Having said all that, there is no question that there is increased pressure to give medications to apparently well asymptomatic people. This pressure certainly comes at least in part from the pharmaceutical industry, for obvious reasons. I would agree that there are severe doubts as to whether we should turn almost everyone into chronic patients but I doubt it would cause much psychological trauma. The reality is that anything up to 60% of patients outside clinical trials do not take statins, for instances, as prescribed or at all. This is for drugs with a reputation for being "well-tolerated". So many expensive drugs would find their way into our sewers without transiting our patients. But they would have been paid for. We need a more realistic perspective on what our population will accept, what the NHS can afford, and the real absolute benefits of intervening. To misquote the TV programme, we should curb our enthusiasm. Competing interests: None declared
Deep down the medical science is very shallow 27 June 2005
BM Hegde, Retd. Vice Chancellor Mangalore 575004, India Send response to journal: Re: Deep down the medical science is very shallow	Dear Editor, This is the most significant article in the BMJ in a very long time. Congratulations to you for publishing and to the authors for their courage. William Blake once said: “he who desires, but acts not, breeds pestilence”. The conventional research in medical science, better called statistical science, is all redcutionist and is based purely on the bio- medical model of disease. The future predictions based on statistics are unpredictable full of “butterfly effects.”(1) We are trying to medicalise the whole population, if one were to believe that almost 90% of the population, by the age 40, will have at least one “so called” risk factor qualifying for drug intervention. With the kind of drugs at our command the future of mankind looks really bleak!(2) Intervening in symptomatic patients is a different cup of tea altogether. Drug treatment of healthy people with mild hypertension, when viewed differently shows the darker side. The MRC trial of mild hypertension, for example, showed that to save one person from stroke in the future we will have to treat 850 people unnecessarily with drugs!(3) One could only imagine the plight of those 850 people taking antihypertensive drugs. Apart from the serious long term side effects, those drugs also make patients to lose their right to “life, liberty and pursuit of happiness.” The HOT study was stopped prematurely since the death rate in the treated group outnumbered the controls.(4) The arbitrary nature of defining “normality” of blood pressure could be seen in the excellent book “Disease Inventors”, by a German, Professor Jerg Blech. The cut off point keeps dropping by the day, naturally to net more and more people under that label. Now even the reading 120/80 is said to be hypertension! We still refuse to believe there is land as we see nothing but sea. While the physiology of organ function depends on the mean capillary pressure, we do not know what happens to the mean capillary pressure when we reduce the arterial pressure arbitrarily? Some times the raised pressure might even be a compensatory mechanism. The first, and, to my knowledge, the only proof that lowering blood pressure helps is the article published in JAMA in 1967.(5) This was a placebo controlled study. The patient numbers were small. Even among them a significant percentage of the treated group dropped out because of side effects. Despite this big statistical lacuna the results were based on the intention-to-treat analysis. There has never been another placebo controlled study for obvious reasons, as we have been selling the idea that it is unethical to leave mild-moderate hypertensives alone with only life style changes, although, by default, the Australian study did show that nearly 40% of the control group did become normotensive on TLC, changed diet, cessation of smoking and alcohol, exercise, weight reduction et cetera. (6)(7) Long term drug treated and “well controlled” hypertensives showed significantly higher death rate compared to their normotensive cousins in society! (8) Long term follow up of medically intervened healthy people’s group showed higher all cause mortality compared to their controls (9) All these and more would prove Goethe right when he said that “ man is absolutely certain when he knows little, with (more) knowledge doubts increase.”. With more knowledge in human physiology we will have to embrace the science of non-linearity and chaos. Raised cholesterol as an indication for drug treatment in the healthy segment of the populace is another huge hoax in medicine but, I need not go into it here as people have already done that earlier. A study of elderly showed that those with the highest cholesterol levels lived the longest. (10) “That, that is is,” wrote Shakespeare in the Twelfth Night. References: 1) Firth WJ. Chaos-Predicting the unpredictable. BMJ 1991; 303:1565- 8. 2) Carlberg B, et al. Atenolol in hypertension: is it a wise choice? Lancet 2004; 364: 1684-1689. 3) MRC trial group. Treatment of mild hypertension-Principal results. BMJ 1985; 291: 97-99. 4) Hot Study Group: Hypertension Optimum Treatment. Lancet.1998;351:1755- 1762. 5) Fries ED. Effects of treatment on morbidity in hypertension JAMA 1967; 202: 116-121. 6) Australian National Blood Pressure Study Committee. Australian therapeutic trial in mild hypertension. Lancet 1980; i: 1261-1267. 7) Hegde BM, Shetty MA, and Shetty MR. Hypertension-Assorted Topics. Book 1997. Bharathiya Vidya Bhavan, Bombay. India. 8) Andersson OK, Almgren T, Persson B, et. al. Survival in treated hypertension: follow up study after two decades. BMJ 1998; 317: 167-71. 9) Strandberg TE, Salomaa VV, Naukkarinen VA, et. Al. Long-term mortality after 5-year multi-factorial primary prevention of cardiovascular diseases in middle-aged men. JAMA 1991; 266: 1225-9. 10) Krumholz HM, et al. Lack of association between cholesterol and coronary heart disease mortality and morbidity and all-cause mortality in persons older than 70 years. JAMA 1994; 272: 1335-1340. Yours ever, bmhegde Competing interests: None declared
Iatrogenic mass hypochondria 27 June 2005
Shashikiran Umakanth, Associate Professor of Medicine Melaka-Manipal Medical College, 75150 Melaka, Malaysia Send response to journal: Re: Iatrogenic mass hypochondria	Dear Editor, I have read the editorial by Westin & Heath and the subsequent rapid responses to that article with great interest. The extremes of views apparent in some of these are very bothering. At the same time, some of the statistical calculations were very humorous yet hit the bull's eye. Let me first make it very clear that my views are very similar to those presented in the editorial. This notion has been bugging me for a long time. If the current trend continues we may reach a time when nobody may be considered 'healthy'. The WHO may need to redefine health in the near future. Currently it goes 'Health is not just absence of sickness, but a state of physical, mental and social wellbeing'. It may be changed to 'Health is not just absence of sickness, but absence of all risk factor(s) for all possible sicknesses'. More than 90% of a population may be considered 'sick'. And then by statistical inference, those who are sick will be considered 'normal' and those who are 'healthy' with no risk factors will be 'abnormal' or 'sick'!. How much more paradoxical and paranoid can it get? I would also like to take this opportunity to respond to the letter by Raymond A Meleady, Consultant Cardiologist, published above. He has suggested that we need not wait for absolute proof, and has interestingly quoted the matter of the cholera epidemic. But Snow just turned off the Broad Street pump. Translating the analogy to cardiovascular risk reduction, we must absolutely turn off the 'Broad Street pump' of cardiovascular risk. I bring to his attention sedentary lifestyle, high fat diet and 'junk' food. Talking of analogies, the 'Broad Street pump' for respiratory illnesses is cigarette smoking, but I don't see anybody actually turning off the pump there! Recently during the Iraq 'war', I visited the US for a conference on insulin resistance. One of the speakers, in the middle of the lecture, projected a slide - "Weapons of Mass Destruction Found in US!'. We were all flummoxed. It was a very uncertain moment as the speaker was not American. The next slide showed photographs of the major 'junk' food outlets that have originated in the US and have infested many other countries. It was a point very well made. Now, that was another illustration 'Broad Street pump' of cardiovascular disease. But what have we done about it? The picture is becoming clearer now. Any recommendation that advocates 'consumerism', applying that term even to prescription drugs, is wholeheartedly supported by the industry. Industry is the backbone of any Government. That recommendation becomes national policy. Vice versa is also absolutely true. To the best of my knowledge, there is no country in this World where cigarette sales are illegal. What we are inducing is not mass neurosis. It is mass hypochondria. We can afford to have a more balanced and responsible view. Regards, Shashikiran Umakanth Competing interests: None declared
Proportion of people eligible for BP and cholesterol lowering treatment greatly exaggerated 27 June 2005
D Graham Mackenzie, Specialist Registrar, Public Health Fife NHS Board, Cameron House, Cameron Bridge, Windygates, Leven, KY8 5RG, John F Forbes, Philip Rutledge Send response to journal: Re: Proportion of people eligible for BP and cholesterol lowering treatment greatly exaggerated	Editor: The editorial by Westin and Heath1 covers an important topic – the eligibility for blood pressure (BP) and cholesterol lowering treatment, in this case in European cardiovascular disease (CVD) guidelines. The European guidelines are in fact little different in concept to UK guidelines, and Westin and Heath greatly over-estimate their potential impact. CVD guidelines over many years have used relatively low thresholds for BP and cholesterol, but also require the assessment of CVD risk factors and target organ damage. Guidelines recommend either estimating CVD risk2,3 , or counting the number of CVD risk factors4. Indeed Westin and Heath’s editorial references one of these guidelines2. To demonstrate the importance of including CVD risk factors in the analysis, we have used anonymised individual patient data for 35-74 year olds (n=3,411) from the Scottish Health Survey 1998 to assess eligibility for cholesterol or BP lowering treatment in primary prevention of CVD. We included the approach used by Westin and Heath (blood pressure and cholesterol criteria only) and the approach laid out in the European and UK guidelines (assessment of CVD risk or number of CVD risk factors in addition to BP and cholesterol thresholds). The assessment of BP and cholesterol alone reproduces Westin and Heath’s findings closely with over 80% of 35-74 year olds eligible for BP or cholesterol lowering treatment. However once CVD risk assessment is included the proportion eligible is markedly reduced to between 12-18% of 35-74 year olds. Westin and Heath presented an over-simplification that was misleading. Mackenzie DG, Public Health Department, NHS Fife Forbes JF, Public Health Sciences, University of Edinburgh Rutledge P, Public Health Department, Lothian NHS Board References 1. Westin S, Heath I. Thresholds for normal blood pressure and serum cholesterol. BMJ 2005; 300: 1461-2. 2. De Backer G, et al. European guidelines on cardiovascular disease prevention in clinical practice. Third joint task force of European and other societies on cardiovascular disease prevention in clinical practice. Eur Heart J 2003; 24:1601-10. 3. Williams B et al. British Hypertension Society guidelines for hypertension management 2004 (BHS-IV): summary. BMJ 2004; 328:634-40. 4. Guidelines Committee. 2003 European Society of Hypertension – European Society of Cardiology guidelines for the management of arterial hypertension. Journal of Hypertension 2003; 21: 1011-1053. Competing interests: None declared
Medicalisation is not a synonym for drug treatment 30 June 2005
Linn Getz, Occupational physician and PhD student Landspitali University Hospital,101 Reykjavik, Iceland, Johann Agust Sigurdsson, Irene Hetlevik Send response to journal: Re: Medicalisation is not a synonym for drug treatment	Editor. The editorial by Westin and Heath (1) refers to our research paper (2), which addresses ethical dilemmas arising from implementation of the 2003 European guidelines on cardiovascular disease (CVD) prevention (3) in a Norwegian context. We want to comment upon the responses, particularly the one by Mackenzie et al. Our paper (2) addressed the prevalence of a simple CVD risk state, defined as "BP equal to or above 140/90 mmHg (or being on hypertensive treatment) and/or total cholesterol equal to or above 5 mmol/l." According to the guidelines, individuals who fulfil one or both of these criteria are in need of medical attention and follow-up (3). This does not necessarily mean that they are eligible for drug treatment. The paper (2) is simply scrutinizing the idea of telling so many people in one of the worlds longest-living and healthiest-living populations (according to WHO statistics) that their health situation should be regarded as sub-optimal from a biomedical point of view, accompanied by a suggestion that something ought to be changed. For those interested in comparing our data with local data, the mean values of the relevant risk factors can be found in our paper (2). Whilst preparing our study, we were allowed to perform preliminary calculations on risk factor prevalences from the Population study of women in Gothenburg, Sweden (4), and the results were similar. The mean values of cholesterol and blood pressure in our study are also in line with results from comparable countries who took part in the MONICA project (third phase, 1992-4) (5). In total, there is no indication that Westin and Heath rely upon data that overestimate the prevalence of CVD disease risk labelling. We regard the problem related to risk labelling as their main concern. Our research group has continued to analyse the prevalence of individuals who will be classified as "high risk for CVD" by use of the SCORE system which underlies the risk estimation system in the European guidelines on CVD prevention (3). This analysis has been requested in some of the rapid responses. The study has already been submitted. To our opinion, our profession should be engaged in a debate on the goals, means and ethics of preventive medicine (6). Our research group is aware of the theoretical basis for clinical guidelines in the prevention of cardiovascular diseases, and also the lack of adherence to these in clinical practice. In a recent editorial (7), we therefore call for a reflection upon the sustainability and responsibility of the type of preventive medicine that is promoted by contemporary guidelines on CVD prevention. As grass-root clinicians and researchers we are concerned that authoritative CVD preventive medicine is not on an optimal track, despite the fact that current guidelines might be regarded as methodologically correct in a technical sense, and claim to present "all relevant evidence" (3). All relevant evidence is, however, not presented in (3) as estimations of the size of the population at risk were not included. Since Shakespeare has already been quoted in this Rapid Response sequence, the ever decreasing thresholds for intervention tempt us to quote Polonius (Hamlet Act II, Scene II): Though this be madness, yet there is method in it. On behalf of our research group, Linn Getz (linngetz@med.is), Johann A. Sigurdsson, Irene Hetlevik References 1) Westin S, Heath I. Thresholds for normal blood pressure and serum cholesterol. BMJ. 2005; 330(7506): 1461-2. 2) Getz L, et al. Ethical dilemmas arising from implementation of the European guidelines on cardiovascular disease prevention in clinical practice: descriptive epidemiological study. Scand J Prim Health Care 2004;22:202-8. 3) De Backer G, et al. European guidelines on cardiovascular disease prevention in clinical practice. Third joint task force of European and other societies on cardiovascular disease prevention in clinical practice. Eur Heart J 2003; 24:1601-10. 4) Bengtsson C, et al. The Prospective Population Study of Women in Gothenburg, Sweden, 1968-69 to 1992-93. A 24-year follow-up study with special reference to participation, representativeness, and mortality. Scand J Prim Health Care 1997; 15: 214-9. 5) Tunstall-Pedoe H (ed.) for the WHO MONICA project. MONICA monograph and multimedia sourcebook. Geneva: World Health Organisation, 2003. Accessible through www.who.int. 6) Roberts MJ, Reich MR. Ethical analysis in public health. Lancet 2002;359:1055-9. 7) Getz L, et al. Individually based preventive medical recommendations - are they sustainable and responsible? A call for ethical reflection. Editorial. Scand J Prim Health Care 2005:23:65-7. Competing interests: None declared
The root of the problem... 1 July 2005
James Penston, Consultant Physician/Gastroenterologist Scunthorpe General Hospital, Cliff Gardens, Scunthorpe, North Lincolnshire DN15 7BH Send response to journal: Re: The root of the problem...	Editor, Westin and Heath [1] argue persuasively against the low thresholds of blood pressure and cholesterol levels for preventive treatment of cardiovascular disease as advocated in the European guidelines.[2] Moreover, their concern about the widespread implementation of these recommendations is entirely warranted. However, the prospect of stopping the medicalisation of large sections of the population seems remote. The ground has been too well prepared. More than a generation of doctors has been programmed to accept without question ever larger trials reporting ever smaller therapeutic benefits. Steeped in the language of risk, they see nothing untoward in prescribing long-term drug therapy to patients even though the vast majority will not suffer from a cardiovascular event and an even higher proportion stand to gain nothing whatsoever from many years of continuous medication. There are, of course, voices of dissent within the medical profession but, while noting the authors’ opinions, there is no evidence of a substantial rebellion. Certainly, few are willing to put their heads above the parapet and even fewer will do so in future. How many GPs will decline the financial inducements in their new contract and refuse to seek out asymptomatic individuals for a cocktail of aspirin and statins? And how many doctors in secondary care will have the courage to ignore guidelines when compliance becomes mandatory for revalidation? [3] For too long, the medical profession has danced to the tune of the statisticians. [4] Insidiously, the obscure notions of risk have triumphed over common sense. By stealth, a new paradigm in medicine has emerged: this is the source of the grotesque pronouncements of committees of experts and the explanation for how such nonsense is accepted without so much as a murmur. References [1] Westin S, Heath I. Thresholds for normal blood pressure and serum cholesterol. BMJ 2005;330;1461-2. [2] De Backer G, Ambrosioni E, Borsch-Johnsen K, Brotons C, Cifkova R., et al. European guidelines on cardiovascular disease prevention in clinical practice. Third joint task force of European and other societies on cardiovascular disease prevention in clinical practice. Eur Heart J 2003;24;1601-10. [3] Norcini JJ. Where next with revalidation? BMJ 2005;330;1458-9. [4] Penston J. Fiction and fantasy in medical research: the large- scale randomised trial. The London Press. London, 2003. Competing interests: None declared
Refreshingly objective physicians 2 July 2005
John P Heptonstall, Director of the Morley Acupuncture Clinic Leeds LS27 8EG Send response to journal: Re: Refreshingly objective physicians	How refreshing it is to read such an objective opinion on the questionable antics of the WHO, that private organisation which seeks to influence global medicine, from cradle to grave, yet has no democratic development or status of, by or for the people hence no "duty of care" to the people. I would be very interested to know just what evidence the WHO has for these probably ridiculous guidelines for blood pressure and cholesterol levels - I have read no convincing evidence for the blood pressure or cholesterol level guidelines set by the WHO which in so many cases of healthy adults and children can only be achieved through medication, and suspect neither have the authors...yet the UK DoH appears to accept them since an advert appears regularly on UK TV citing UK government advice being that having a cholesterol level >5.0 is a serious risk of heart disease. I suspect this ad, sporting at least one Big Pharma name, betrays both advertising law and good science. I have seen a number of patients in recent years who claim their greatest mistake was "having taken a free cholesterol skin prick test" at a local pharmacy or chain store only to be told their GP will be contacting them soon as their "cholesterol is too high" being over 5.0; some of those unlucky enough to have been over 6.0 found themselves prescribed statins and within a few weeks developed unexpected arthritis so NSAIDS follow, a few more months and angina is diagnosed with more drugs being prescribed... Had they avoided that free test would they have remained free of arthritis and cardiac symptoms and maintained their original healthy state with a cholesterol over 6.0? I (and they) think so. We hear much about the "dread cholesterol" and little about the "mortality and morbidity preventing" and life enhancing cholesterol of yesteryear. I would value a response from anyone who can prove me (and them) wrong. I strongly suspect there is more evidence for an iatrogenic causal chain of illness stretching from the prescriptions following an unfortunate "free cholesterol test" through to angina. Regards John H. Competing interests: None declared
A threshold too far? 2 July 2005
Jean P Fisher, Salaried GP Salford M27 Send response to journal: Re: A threshold too far?	The editorial by Westin and Heath1 on thresholds for treatment of blood pressure and cholesterol should be applauded. It is time for the patient (person?) centred doctor to stand up against the increasing push to medicalise the normal aging process. We have long known that labelling an individual as hypertensive is sufficient to increase absenteeism from work2, but who is weighing this iatrogenic loss of quality of life against the benefits? Although we are all trained to consider the patient’s ideas concerns and expectations, it seems that these are not taken into consideration in drawing up ever more stringent guidelines. Patients’ views on the value of preventive medication differ from those of professionals3. Most importantly, both lay and professional views depend on how that information is presented, - as relative risk reduction, absolute risk reduction or number needed to treat4,5. Few of us could honestly say that we discuss number needed to treat when advising patients of the benefits of anti-hypertensives or statins – fewer still when payment in primary care depends on achieving good compliance. If we start using number needed to treat in our consultations perhaps we might find that patients disagree with the guidelines. Remember when the guidelines tell us to push treatment up to the maximum tolerated dose, we are really asking the patient to take just less than makes treatment unbearable. 1. Westin, S. & Heath, I. Thresholds for normal blood pressure and serum cholesterol. BMJ 2005;330: 1461-1462 2. Haynes, R.B., Sackett, D.L., Taylor, D.W., Gibson, E.S. and Johnson, A.L. Increased absenteeism from work after detection and labelling of hypertensive patients. N Engl J Med 1978; 299:741-744. 3. Steel, N. Thresholds for taking antihypertensive drugs in different professional and lay groups: questionnaire survey. BMJ 2000; 320: 1446-1447. 4. Misselbrook, D. & Armstrong, D. Patients’ responses to risk information about the benefits of treating hypertension. Br J Gen Pract 2001; 465: 259-260. 5. H C Bucher, M Weinbacher, and K Gyr. Influence of method of reporting study results on decision of physicians to prescribe drugs to lower cholesterol concentration. BMJ 1994; 309: 761 - 764. Competing interests: None declared
Primary prevention of cardiovascular disease 5 July 2005
B Kirkup, GP Latham House Medical Practice, Melton Mowbray, Leics LE13 1NX Send response to journal: Re: Primary prevention of cardiovascular disease	Dear Editor I was pleased to read your editorial by Westin and Heath(1) in which they point out the pitfalls of following ever decreasing thresholds at which to intervene with drugs in the primary prevention of cardiovascular disease. My pleasure was short lived when two days later I was faced with this headline in one of the GP newspapers(2) ‘Nice triggers row over rationing of statins’. Nice had the temerity to suggest in its draft appraisal on primary prevention that they may suggest the use of statins in people with a 10yr CHD risk of 20%, producing an angry response from members of the Primary Care Cardiovascular Society and British Hypertension Society who see this as a backward step and urge GP’s to use a 15% 10yr CHD threshold. At this level of intervention one half of the population over the age of 40 without symptomatic cardiovascular disease would qualify as at risk (3) This reminded me that the primary prevention of cardiovascular disease is still dominated by groups who are attached to a ‘high risk’ strategy, their belief being that the at risk group can be targeted using charts derived from the Framingham equation. Brindle (4)has pointed out that the Framingham equation overestimates the risk in a British population, and that intervention at a 30% or 15% CHD risk level lacks both sensitivity and specificity for targeting the at risk group. Wald and colleagues in an elegant series of articles (5,6,7) have pointed out why such an approach will inevitably miss a large part of the population who are at risk, leading to their suggestion of a polypill for all from a specified age. While being very impressed with the impeccable logic of their argument I find myself philosophically unable to commit to treating a whole cohort of people with a cocktail of drugs when I know that at least half of them are not at risk of cardiovascular disease. Is there another way that can save me from the ‘high risk’chartists? What seems to have become lost from this discussion is the place for a ‘population based’ rather than a ‘risk based’ strategy. Emberson et al (3) suggest that a 10% reduction in population blood pressure and cholesterol would lead to a 45% reduction in major CVD risk.Unal et al (8) make similar claims, and note that favourable declines in cholesterol, blood pressure have been achieved in other developed countries. These reductions are significantly greater than those likely to be achieved with statins. A combination of a population based strategy and a risk strategy set at a 30% CHD risk, with data for that preferably from a British cohort would seem a good level to begin a discussion. The general practice workload would be manageable and fewer patients would struggle under the psychological burden of being at risk. There is a disjointed feel to primary cardiovascular prevention at the moment and bearing in mind the massive number of people the ‘risk strategy’ group wish to turn into patients, this is a major public health issue and it may be a good idea if the Department of Health became involved. They might even consider a working party populated mainly with a majority of epidemiologists and GP’s, Yours sincerely, Dr B Kirkup GP Latham House Medical Practice, Melton Mowbray, Leics, LE13 1NX 1. Westin S, Heath I. Thresholds for normal blood pressure and serum cholesterol.BMJ 2005;330: 1461-2. 2. Pulse 2005; 65 No 25 Front page main story. 3. Emberson J, Whincup P, Morris R et al. Evaluating the impact of population and high-risk strategies for the primary prevention of cardiovascular disease. Europ Heart Journal;2004: 25 484-91. 4. Brindle P, Emberson J, Lampe F et al. Predictive accuracy of the Framingham coronary risk score in British men: prospective cohort study. BMJ 2003; 327: 1267-70 5. Wald N J, Hackshaw A K and Frost C D. When can a risk factor be used as a worthwhile screening test. BMJ 1999; 319: 1562-65. 6. Law M R and Wald N J. Risk factor thresholds: their existence under scrutiny. BMJ 2002; 324: 1570-76. 7. Wald N J and Law M R. A strategy to reduce cardiovascular disease by more than 80%. BMJ 2003; 326: 1419-23 8. Unal B, Critchley J and Capewell S. Small changes in United Kingdom cardiovascular risk factors could halve coronary heart disease mortality. J of Clin Epidemiology 2005;58: 733-40. Competing interests: I have a modest shareholding in Astra-Zeneca and stand to be penalised by my suggested actions, but think I can cope.
A blinkered approach to the prevention of cardiovascular disease 8 July 2005
Graham A MacGregor, Professor of Cardiovascular Medicine Blood Pressure Unit, St. George’s University of London, Cranmer Terrace, London SW17 0RE., Feng J. He Send response to journal: Re: A blinkered approach to the prevention of cardiovascular disease	Drs Westin and Heath's editorial [1] illustrates a blinkered approach to the prevention of cardiovascular disease. Strokes, heart attacks and heart failure are the leading causes of death and disability in the UK and worldwide. Eighty percent of these events are caused by raised blood pressure and raised cholesterol throughout the range and smoking [2]. Not surprisingly, 95% of the adult population in developed countries are at risk of developing cardiovascular disease [3]. To prevent cardiovascular disease both in the UK and globally, two strategies need to be adopted, firstly to lower both population blood pressure and cholesterol and stop smoking, and secondly to target individuals who are particularly at high risk. These people are not patients and have no symptoms, they are merely at greater risk and will benefit from either more assiduous lifestyle changes and/or taking tablets. The question is what is the degree of risk and benefit obtained that requires intervention with tablets? Currently in the UK blood pressure is classed as "high", i.e. needs treatment, if consistently greater than 160/100 mmHg or 140/90 mmHg if there is increased cardiovascular risk (based on BHS Guidelines) [4]. Westin and Heath are rightly concerned about potential side effects of tablets. However, modern therapy for hypertension can control blood pressure in the majority of individuals without side effects. Only 10% of individuals in the UK have their blood pressure controlled to the target of 140/90 mmHg [5]. Because of this, very large numbers of strokes, heart attacks and heart failure are occurring unnecessarily. If all hypertensive individuals had their systolic controlled to the target of 140 mmHg, approximately 120,000 strokes and heart attacks would be prevented each year in the UK, 60,000 of which are fatal [6]. Westin and Heath are correct to point out the potentially huge task for GPs, or perhaps more correctly practice nurses. Instead of giving up, we need to think much more entrepreneurly about how to manage this problem and to give more responsibility to the individuals who are affected. A large number of individuals are happy to be empowered to control their own blood pressure with home monitors and report back to the practice nurse and receive prescriptions without seeing a doctor. If there are legal or contractual obstructions then these need to be changed. For instance, there is a requirement in the new GMS contract that individuals need to have their blood pressure measured every nine months, but this could be changed if the patient's own measurements were used. What is the point in GPs or practice nurses following up individuals who have well-controlled blood pressure and could manage it themselves? They should be focussing on those individuals whose blood pressure is not controlled, and those who should be on treatment but are not, or who have never had their blood pressure measured. The control of both blood pressure and cholesterol, both from lowering population blood pressure and cholesterol and controlling individuals with raised blood pressure and cholesterol will be immensely beneficial in reducing the appalling burden of strokes, heart attacks and heart failure in the UK. Feng J. He, Cardiovascular Research Fellow Blood Pressure Unit, St. George’s University of London, Cranmer Terrace, London SW17 0RE. Graham A. MacGregor, Professor of Cardiovascular Medicine Blood Pressure Unit, St. George’s University of London, Cranmer Terrace, London SW17 0RE. Tel: 020-8725 2989. Fax: 020-8725 2959. E-mail: g.macgregor@sghms.ac.uk References [1] Westin S, Heath I. Thresholds for normal blood pressure and serum cholesterol. BMJ. 2005;330:1461-1462. [2] Emberson JR, Whincup PH, Morris RW, Walker M. Re-assessing the contribution of serum total cholesterol, blood pressure and cigarette smoking to the aetiology of coronary heart disease: impact of regression dilution bias. Eur Heart J. 2003;24:1719-1726. [3] Beaglehole R. Global cardiovascular disease prevention: time to get serious. Lancet. 2001;358:661-663. [4] Williams B, Poulter NR, Brown MJ, Davies M, McInnes GT, Potter JP, Sever PS, Thom S McG. The BHS Guidelines Working Party Guidelines for Management of Hypertension: Report of the Fourth Working Party of the British Hypertension Society, 2004 – BHS IV. J Hum Hypertens. 2004; 18: 139-185 [5] Primatesta P, Brookes M, and Poulter NR. Improved hypertension management and control: results from the Health Survey for England 1998. Hypertension. 2001;38:827-32. [6] He FJ, MacGregor GA. The cost of poor blood pressure control in the UK: 62,000 unnecessary deaths per year. J Hum Hypertens. 2003:17:455- 7. Competing interests: None declared
Re: Editorial: Thresholds for normal blood pressure and serum cholesterol. BMJ 2005;330:1461-2 12 July 2005
Prof Ian M Graham, Professor of Epidemiology and Public Health Medicine Royal College of Surgeons in Ireland, Prof Guy de Backer, Prof Kalevi Pyörälä Send response to journal: Re: Re: Editorial: Thresholds for normal blood pressure and serum cholesterol. BMJ 2005;330:1461-2	30th June 2005 Dear Sir The medical and public health implications of recommendations on the prevention of cardiovascular disease, such as Third Joint European Guidelines on Cardiovascular Disease Prevention in Clinical Practice (1) deserve careful consideration. However, your editorial on this subject by Westin and Heath (2) displays a startling lack of understanding of both the European recommendations and indeed of the basic principles of risk prediction. Firstly, the ability to estimate cardiovascular risk in healthy people allows such people the opportunity to take positive action to reduce their risk of disability or death from heart attack and stroke. It has nothing whatsoever to do with labelling such healthy people as "sick" or "patients". Secondly, it is a simple fact that persons who are physically active, make healthy food choices, do not smoke and have a serum cholesterol level of less than 5 mmol/L and a blood pressure of less than 140/90 mmHg are more likely to remain healthy than those who do not have these characteristics. Thirdly, and of critical importance, the European guidelines DO NOT recommend intensive therapy on the basis of a serum cholesterol of 5 mmol/L or more or a blood pressure of 140/90 mmHg or more. What they DO recommend is the estimation of TOTAL RISK of cardiovascular death (the product of age, sex, smoking, serum cholesterol and blood pressure level) before advising on cardiovascular risk management. Given limited resources, the priorities for CVD prevention in clinical practice are: 1. Patients with established coronary heart disease, peripheral artery disease and cerebrovascular atherosclerotic disease 2. Asymptomatic individuals who are at high risk of developing atherosclerotic cardiovascular disease because of a) multiple risk factors: resulting in a 10 year risk of greater than or equal to 5% now (or if extrapolated to age 60) for developing a fatal CVD event. b) markedly raised levels of single risk factors: cholesterol greater than or equal to 8 mmol/l (320 mg/dl), LDL cholesterol greater than or equal to 6 mmol/l (240 mg/dl), blood pressure greater than or equal to 180/110 mmHg. c) diabetes type 2 and diabetes type 1 with microalbuminuria. 3. Close relatives of a) patients with early onset atherosclerotic cardiovascular disease b) asymptomatic individuals at particularly high risk 4. Other individuals encountered in routine clinical practice Fourthly, the advice for managing high risk subjects focuses on lifestyle change as the fundamental approach to management. "Those at highest total risk should be identified and targeted for intensive lifestyle interventions and, where appropriate, for drug therapies" (1). While we accept the need for caution in applying the results of therapeutic trials in the long term, we would contend that the randomized control trial is the best tool available to decide if therapeutic benefit exceeds harm, and that the evidence base for the effective treatment of hypertension and hypercholesterolaemia is one of the strongest in the history of medicine. Finally, if our Norwegian colleagues (3 - ref 6, Getz et al in the editorial) have identified an appreciable proportion of their population with less than ideal serum cholesterol and blood pressure levels, they should be congratulated for identifying an opportunity to further improve the health of their people. This could be achieved through reinforcing existing public health messages with regard to nutrition, weight, exercise and smoking for these, the vast majority of whom will be healthy. For the small proportion who already have established vascular disease or are at very high multifactorial risk, more intensive advice and evidence based drug therapies might be required. This is a far cry from the tone of the editorial. The editorial was particularly unfortunate as it has generated singularly incorrect press comments such as “unease over guidelines that label 9 out of 10 people sick”, “European Heart Guidelines label many are sick, doctors say”, “Doctors uneasy about new European health guidelines”. Helping people to remain healthy bears no relationship to labelling them as sick. With kind regards Yours sincerely Prof Ian M Graham FESC, Past-Chairman and member of the Joint European Societies Cardiovascular Prevention Committee, European Society of Cardiology Prof Guy de Backer FESC, Chair, Joint European Societies Cardiovascular Prevention Committee, European Society of Cardiology Prof Kalevi Pyörälä FESC, Member of the Joint European Societies Cardiovascular Prevention Committee, European Society of Cardiology Competing interests: None declared
What about our patients' views? 3 August 2005
Geraint V Jones, General Practitioner The Leiston Surgery IP16 4ES Send response to journal: Re: What about our patients' views?	It has been intriguing to witness the sharp division in opinions expressed in the responses to this editorial. On the one hand, cardiologists advocate lower thresholds for risk factor based prescribing, whilst GPs et al favour less intervention. This seems to me to mirror the findings of Steel's paper of May 2000 (1) where it was found that consultant physicians were minded to prescribe for hypertensives at a NNT (numbers needed to treat) of 100, whereas GPs only felt it worth prescribing at a NNT of 50. However, members of the public thought that treating hypertension became worthwhile when NNTs fell as low as 33. As Marshall points out (2) this broadly equates with a 5 year mortality risk not of 10% or 15% but 30%! In the five years since that study thresholds have been lowered even further, has anyone thought to ask our patients what they really want? (1)Thresholds for taking antihypertensive drugs in different professional & lay groups. Nick Steel BMJ 2000; 320 1446-7 (2)Paper has very important implications.(Rapid response 26 May 200) Tom Marshall. BMJ.com Competing interests: None declared
The combined risk estimate does not solve the problem 17 August 2005
Linn Getz, Occupational physician Landspitali University Hospital, 101 Reykjavik, Iceland Send response to journal: Re: The combined risk estimate does not solve the problem	Editor, As the first author of the paper on which Westin & Heaths editorial is based (see reference in my prior response in this sequence of rapid responses), I am pleased to see that the authors of the debated 2003 guidelines on prevention of cardiovascular disease have found it worth while to enter the debate. Not surprisingly, they emphasise that single risk factors are not the main issue. Rather one should focus on the making a combined risk estimate. We have indeed been aware of this, and I am happy to draw your attention to a paper published in the BMJ yesterday, 15 August 2005 (1). It is a modelling study where we estimate the size of the population at high risk for cardiovascular disease, according to the 2003 European guidelines and the SCORE system. Our conclusion is that the population "at high risk" for CVD is overwhelmingly large. So unfortunately, in the Norwegian setting, the important challenge of prioritising patients given limited resources does not appear to be solved by the combined risk approach. Kind regards, Linn Getz (1) Getz L, Sigurdsson JA, Hetlevik I, Kirkengen AL, Romunstad S, Holmen J. Estimating the high risk group for cardiovascular disease in the Norwegian HUNT 2 population according to the 2003 European guidelines: modelling study. BMJ 2005 (Online first). Access through http://bmj.bmjjournals.com/cgi/rapidpdf/bmj.38555.648623.8F?ijkey=bM2vNPB6XICQu2y&keytype=ref Competing interests: None declared
What to do in routine primary care? – isn’t it screening? 17 August 2005
Franz Piribauer, MD, MPH, Self employed Consultant PiCo Health Consulting, Wimbergergasse 14-16/2-21; A-1070 Vienna, Austria Send response to journal: Re: What to do in routine primary care? – isn’t it screening?	The editorial and the following heated discussion bring to light important key points which have to be addressed when preventive Public Health messages are disseminated through guidelines (1). Not yet discussed are arguments around screening. The intention of the European cardiovascular disease (CVD) guideline is obviously that their thresholds are applied to real European populations. What actions do they recommend for a (primary) care provider in Europe? The guideline proposes, and some of their authors restate it in their recent Rapid Response, that individuals should be categorized in four groups, three groups at risk, and the fourth consisting of „other individuals encountered in routine clinical practice“.(2) How should this happen, how should the three target groups be discriminated from group 4 on a routine basis in the clinician’s office? On what grounds should tests like blood pressure and lipid measurements, or questions for relatives with early CVD onset, be offered or declined? Should it be done arbitrarily or systematically, or not at all? The guidelines are silent on that. Why? Because applying a test systematically to a healthy symptom free population would mean they propose a screening programme. The coverage of such a programme may range from a local GP in his office who follows the guideline personally to a national health service screening programme. In my view, a CVD mass screening programme is proposed implicitly for the European population. The heated discussion following the editorial is based on the assumption that such a screening has happened and hundred of thousands of symptom free individuals have been labelled as at risk with good or bad consequences. Is such a screening programme good or bad? To make explicit, what is implicitly recommended, to name it what it is, a screening programme, is very good. As for screening programmes high ethical standards and tough professional criteria have been developed over decades. Elaborate judgements systems on the quality of the evidence on the harm / benefit ratio for every single element in such programmes are available now, and should be followed. The first were presented under the umbrella of the WHO in the 1960s, more elaborate ones have been applied and published recently in the US and the UK (3) (4) (5). At least mass screening programmes have to answer the questions for potential harm of the screening test, and the following intervention/ therapy with all available evidence, before mass implementation in a healthy population can be considered. This is an ethical questions with high profile (6) (7). In the editorial six issues were presented entailing serious questions in the final paragraph. Five revolve around the magnitude of the benefit/ harm balance and the sixth asks finally for the cost effectiveness of such population wide risk interventions. To my surprise the authors defending their guideline and criticising the editorial in the rapid response from 12. July 2005 did not even mention those six issues, and implicitly addressed only one, the problem of lacking long time therapy trials(8). For instance the first editorial issue raises two simple and important questions in the interest of the patient: What is the number needed to treat (NNT) at my (low) level of risk? What is the expected rate of side effects in relation to the NNT at my level of risk? Even in the long version of the European guidelines this two questions were not answered on 64 text pages, and on page S15 NNTs were found not to be feasible to be presented for different European populations (9). However, like Australian and New Zealand guidelines groups have shown it is feasible, and they did present NNTs in relation to absolute risk levels (10;11). Offering healthy individuals at different levels of CVD- risk such numbers provide in my opinion for a better informed choice than withholding such numbers. It may be impossible to be accurate on a percentage of one or five, but if there are NNTs for a year like 1: 100 or 1: 500 or even more, they give the patient and the doctor a feeling for the dimensions they deal with in their treatment decisions. Lowering thresholds for normal values, without providing at least the physician such quantitative information on the higher NNTs for therapy at lower risk levels would be difficult to justify in preventive programmes which include screening at some points. Therefore I like to see the discussed guideline as a screening, detection, and follow up programme for CVD risk/ disease. Thus the evidence base and the components of such a guideline targeted at symptom free individuals at different risk levels should be judged applying the best methods available now for such screening programmes. After this exercise the recommendations may be more balanced and tailored to the preferences of individuals, not yet patients and support better the daily routine of physicians who want to keep the individuals entering their office healthy. Reference List (1) Westin S, Heath I. Thresholds for normal blood pressure and serum cholesterol. BMJ 2005; 330(7506):1461-1462. (2) De Backer G, Ambrosioni E, Borch-Johnsen K, Brotons C, Cifkova R, Dallongeville J et al. European guidelines on cardiovascular disease prevention in clinical practice: Third Joint Task Force of European and other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of eight societies and by invited experts). Eur Heart J 2003; 24(17):1601-1610. (3) Wilson JM, Jungner YG. [Principles and practice of mass screening for disease]. Bol Oficina Sanit Panam 1968; 65(4):281-393. (4) Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD, Teutsch SM et al. Current methods of the US Preventive Services Task Force: a review of the process. Am J Prev Med 2001; 20(3 Suppl):21-35. (5) Gray JAM. Screening in England, NSC Programmes Director's Report. UK National Screening Committee, editor. Screening in England . 2003. Institutes of Health Sciences. Ref Type: Report (6) Shickle D, Chadwick R. The ethics of screening: is 'screeningitis' an incurable disease? J Med Ethics 1994; 20(1):12-18. (7) Gray JAM, Piribauer F. Realising the potential benefit of screening. Comment on the outcomes of the first Austrian Screening Guidelines Consensus Conference. Wien Klin Wochenschr 2001; 113(1-2):4-6. (8) Graham IM, De Backer G, Pyorala K. Re:Editorial: Tresholds for normal blood presure and serum cholesterol. BMJ 2005; 330:1461-2. BMJ Rapid Response . 12-7-2005. BMJ.com. Ref Type: Electronic Citation (9) De Backer G, Ambrosioni E, Borch-Johnsen K, Brotons C, Cifkova R, Dallongeville J et al. European guidelines on cardiovascular disease prevention in clinical practice: third joint task force of European and other societies on cardiovascular disease prevention in clinical practice (constituted by representatives of eight societies and by invited experts). Eur J Cardiovasc Prev Rehabil 2003; 10 (suppl 1)(4):S1-S78. (10) National Prescribing Service Limited. New Zealand Cardiovascular Risk Calculator. http://www.nps.org.au/resources/Health_Professional_Tools/nz_cardiovascular_risk_calculator.pdf . 2004. National Prescribing Service Limited. 16-8-2005. Ref Type: Electronic Citation (11) The New Zealand Guidelines Group. The Assessment and Management of Cardiovascular Risk. www.nzgg.org.nz , 1-220. 2003. 15-3-2004. Ref Type: Electronic Citation Competing interests: I have been payed for consulting advice to the Main Association of Public Sick Funds, Vienna, Austria for the reform of the national Periodic Health Examination during 2001 - 2005.
Is it Ethical to Medicalise Normality 18 August 2005
Tim M Reynolds, Professor of Chemical Pathology Queen's Hospital, Burton-on-Trent, DE13 0RB Send response to journal: Re: Is it Ethical to Medicalise Normality	The editorial by Westin & Heath [1] illustrates a worrying trend in the medicalisation of normality. It has been widely trailed that the new Joint British Societies guideline for lipid therapy will be based on the 4:2:1 principle [total-cholesterol 4mmol/L; LDL-cholesterol 2mmol/L; and HDL-cholesterol 1mmol/L]. This is a difficult goal if applied to secondary prevention but is liable to become the goal for primary prevention as well. I already receive many primary prevention referrals to my lipid clinic of patients who fail to achieve the QoF target of 5 mmol/L despite a lack of any significant risk factors apart from elevated total cholesterol (often the HDL-cholesterol is high and treatment is therefore doubly unwarranted). New lower targets will inevitably be applied to all of the population. Since the UK population average cholesterol for males is 5.8 ± 1.21 mmol/L [2], only those individuals with cholesterol more than 1.5 standard deviations below the mean will be ‘normal’; i.e. 93.5% of British men will be ‘hypercholesterolaemic’. Getz et al, [3] are therefore entirely correct: It is necessary for us to have a debate about the methods and ethics of preventative medicine. The creeping reduction of treatment thresholds is moving us from treating patients as individuals to treatment of entire populations and can be likened to the addition of fluoride to drinking water to prevent dental decay. Whilst this may be a reasonable response to the fact that risk calculation algorithms do not function as we believe them to [4,5], we have to recognise that life is a sexually-transmitted terminal disease and that we cannot eliminate all risks. If we prevent deaths from heart disease, people will probably die of cancer and vice-versa. If we want to convert all individuals to pill-taking cost centres in the Medical- Industrial complex, then we should do so consciously rather than by sleep walking into an era when all risks must be mitigated medically. The international imbalance in healthcare expenditure means that in the West we strive to increase individual lifespan by a few months at massive cost, whilst in other parts of the world much lower expenditure could increase the ‘global sum of health’ by a far greater extent. The debate about prenatal Down’s syndrome screening teaches us ethics is a notoriously difficult area to debate because one person may see an action as self-evident whilst another sees it as utterly unethical. The ethics of medicalisation of entire populations is a debate that needs to begin. He who fights with monsters should look to it that he himself does not become a monster…When you gaze into the abyss, the abyss also gazes into you. Friedrich Nietzsche REFERENCES 1)Westin S, Heath I. Thresholds for normal blood pressure and serum cholesterol. BMJ 2005; 330: 1461-2 2)Health Survey for England: Cardiovascular Disease 1998. HMSO. London 1999 3)Getz L, Sigurdsson JA, Hetlevik I. Medicalisation is not a synonym for drug treatment. http://bmj.bmjjournals.com/cgi/eletters/330/7506/1461#110972 4)Reynolds TM, Twomey P, Wierzbicki AS. Accuracy of cardiovascular risk estimation for primary prevention in patients without diabetes. J Cardiovasc Risk 2002; 9: 183-190 5)Reynolds TM, Twomey P, Wierzbicki AS. Concordance Evaluation of the Coronary Risk Scores: Implications for CHD Risk Screening. CMRO 2004; 20: 811-8 Tim M Reynolds: Professor of Chemical Pathology, Queen’s Hospital, Belvedere Rd., Burton-on-Trent, UK. DE13 0RB. Tim.Reynolds@burtonh-tr.wmids.nhs.uk Competing interests: I run a lipid clinic and have lectured on lipid therapy for several drug companies .
Diseases and risk factors 23 August 2005
Anthony S Wierzbicki, Consultant Chemical Pathologist St Thomas Hospital, London SE1 7EH Send response to journal: Re: Diseases and risk factors	This editorial and the accompanying paper confuse 2 issues-risk factors for atherosclerosis and primary diseases. On the authors' definition and principles any blood glucose > 5 mmol/L would qualify as diabetes. This is absurd. Neither cholesterol nor blood pressure are considered a disease unless levels are extreme: total cholesterol > 8 mmol/L or blood pressure > 160/100 mmHg. Levels of this magnitude are found in small minorities of the population (<10%). There is substantial epidemiological evidence that lipid and blood pressure levels in developed societies are substantially greater than those found in rural aboriginal populations. This is simply a consequence of the Western lifestyles. Hence any respectable laboratory or risk assessment service does not quote normal ranges for these parameters but states that cardiovascular risk increases when cholesterol > 4.0-5.0 mmol/L or blood pressure > 110-120 mmHg. Neither lipids nor blood pressure on their own accurately discriminate risk of cardiovascular disease unless levels are extreme. Risk factors are combined using an epidemiologically derived algorithm (e.g. Framingham) to give an approximate indication of prospective risk of atherosclerotic disease. Cut-offs for treatment are set by Governments and specialist societies based on considerations of evidence of benefit from intervention, cost-benefit analysis and financial considerations. Currently UK government guidelines identify 3-5% of individuals in primary prevention as requiring drug treatment, while international guidelines suggest 5-8% and newer evidence from recent trials currently being incorporated into guidelines suggest 15-20%. These high, but none the less minority, figures simply reflect the depth of failure of preventive measures over the last 50 years and the consequent high burden of atheromatous disease which accounts for 30% of mortalityand vast morbidity. Competing interests: I have received honoraraia, research grants and travel support from AstraZeneca, Bristol-Myers-Squibb, Fourier, Merck, Merck-Sharp & Dohme, Pfizer, Roche, Sanofi-Aventis and Takeda.
Just too smart for our britches? 30 June 2007
Hilary Butler, freelance journalist home 2121, Tuakau, New Zealand. Send response to journal: Re: Just too smart for our britches?	NHS will offer heart 'wonder drug' to all. So said The Sunday times, June 24, 2007. http://www.timesonline.co.uk/tol/life_and_style/health/article1977611.ece Is this 'wonder drug', as Tim Reynolds in a rapid reponse on 18 August 2005, in response to "Thresholds for normal blood pressure and serum cholesterol" http://www.bmj.com/cgi/content/full/330/7506/1461 the start of "the abyss looking back at us"? Will London's recycled water, in a year's time, contain yet another "prescribtion drug" free for all? Then of course, we have another new drug predicted to ensure that women can go through life without having periods. Will an excuse be found to give that to all women once they hit puberty? Also, then, free in recycled water. What else might become pharma El Dorado? Paracetamol daily, to ward off aches and pains before they even happen? Just like aspirin is given now, to ward off heart attacks that haven't happened? And, as the trend is going these days, why not put MMR into the adult vaccine schedule? After all, studies show that because measles isn't circulating very well any more, people who had natural immunity before the vaccine came out, now have declining levels of protection (PMIDs 10548578 and 10381212). And there is plenty of evidence this has happened with pertussis and is happening with chickenpox too. Never mind that measles etc might not be around for adults to get, because... we mustn't forget Aaby's studies in Africa (PMID 12690020) where he shows that children who had neither measles, nor the vaccine, have worse overall survival outcomes overall (because the disease and vaccine to lesser extent, help prime and teach the immune system. This tragic possibility lead him to comment that withrawal of the vaccine after eradication, might lead to an increase in child mortality, so we better use it for ever. It did not, naturally, lead him to discuss the benefits of measles, (or any other) infection in perfectly healthy western children who would never have complications or died from it anyway. However, in the interests of the El Dorado of "Just In Case" medicine, no doubt MMR can be added to the adult vaccination schedule, along with pertussis and chickenpox vaccines, Hepatitis A and at least another 300 new ones in various ways in the days to come, so that we can prevent anything from happening. Ironic, don't you think? It's a bit like this current culture of antibacterial solutions in your kitchen, to keep you safe. But what about the hygiene hypothesis that says that reduction in contact with bugs at an early age, leads to higher development of allergies? Then there is the trend of going to Tesco's and picking up food en masse, prepackaged in polystyrene, and plastic wrap, because we have to present things nicely, and be "clean" and avoid "bugs". So, In the process of being "clean" and avoiding "bugs", we then pollute the world with piles of trash, and in the process of preventing every possible health gliche in the future, we create toxic landfill, thereby polluting water, and possibly derange the metabolism of living organisms in the ecology with plastic chemicals which mimic hormones. Meanwhile, parents in tesco, don't give a thought to the fact that the trolly they use, has been pawed by dirty hands, and might even have had a toddler in it with dirty shoes, and pooey nappies. Hey, I have an idea for everyone. Why doesn't the government simply put out of business, all the companies that manufacture JUNK food, plastic bags, and unnecessary consumer good? Why not ban take-aways based on transfatty acids and refined foods? Why not ban lifts and make people walk stairs? Why not take society back, in some respects, to a time when commonsense prevailed, kids played outside, ran, sang, biked and lived life in the real world, instead of being glued to television, computers etc? Why not return to basic commonsense, and personal responsibility, instead of descending ever more surely into a global nanny state? We know why not. Because health is no longer about common sense, or personal responsibility. Government is no longer about being realistically proactive. This game is all about convenience and dollars. It's all about maximum tax gains from as many companies as possible. It's all about taking people's money off of them in Tescos, and then taking it off them again at the doctors to "protect" them against what they bought in Tesco's. In the end, people can have their cake and eat it: however they will end up totally broke and in debt by the time they die. That is the logical consequences of a Government which promotes the motto of: "Rampant consumerism on food of the worst kinds, consumer products you don't need (good for the economy), but make sure you ALSO spend your billions on the pharma's everything, and keeping your doctor in business, so that everyone else's tills ring with the speed of lightening fast machine guns." No doubt, by the time you are cremated, they won't need a fire either. Bodies might have changed so much with all these complex chemical interactions that some bright spark in the Government might have designed a pill to take when nearing death, which results in spontaneous combustion on activation. This of course, would be promoted in a brochure entitled "Save thousands, Buy your pill today". Hilary Butler. Competing interests: None declared