Pills are not the answer to unhealthy lifestyles
BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3046 (Published 12 July 2018) Cite this as: BMJ 2018;362:k3046
All rapid responses
Further to my previous letter [1] it might be mentioned that according to a recent European Parliament press release [2]:
"MEPs say it is unjustifiable that the cost of a full vaccines package for one child is 68 times more expensive in 2014 compared to 2001."
MEPs may also be being a little naive in consideration of how many new products have been recommended to pan-European schedules during the period. In the case of the United Kingdom body, the Joint Committee on Vaccination and Immunisation products are recommended on the basis of cost-effectiveness, but the question might arise - even if its equations are correct in narrow terms - whether these are being measured against the right things (like overall health and mortality for which there may be insufficient knowledge or understanding).
Indeed, on a down note we read in the same report:
"MEPs stress that increased transparency in evaluating vaccines and their adjuvants, in the funding of independent research programmes and the possible side-effects of vaccines would contribute to restoring confidence in vaccination."
To which it might be wise to add that until this has been done it remains uncertain whether it will lead to "restoring confidence" or the reverse. And it also added:
"They point out that researchers must declare any conflict of interest. Those subject to a conflict of interest should be excluded from evaluation panels. The confidentiality of deliberations of the European Medicines Agency’s (EMA) evaluation panel should also be lifted, and scientific and clinical data be made public."
Something to which many of us look forward.
[1] John Stone, 'Re: Pills are not the answer to unhealthy lifestyles', 16 July 2018, https://www.bmj.com/content/362/bmj.k3046/rr-7
[2] 'Health Committee MEPs warn against dropping vaccination rates', News European Parliament 20 March 2018, http://www.europarl.europa.eu/news/en/press-room/20180319IPR00021/health...
Competing interests: No competing interests
We also need to attend to the over-prescription of other classes of product [1]. In my recently published evidence to the House of Commons Health and Social Committee into anti-microbial resistance I pose the question not only whether there is any use in substituting one kind of over-medication for another, but also whether there can be any certain benefits to further expanding the vaccine programme [2]. Despite everything perhaps we ought to be grateful at this time to be re-considering what public money should actually be spent on. If we managed to navigate ourselves to a position in which the pharmaceutical industry was no longer the tail wagging the dog within the NHS, the Department of Health and Public Health England, it would be the greatest institutional progress I would have seen in my lifetime and the greatest boon to the public.
[1] Fiona Godlee, 'Pills are not the answer to unhealthy lifestyles', BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3046 (Published 12 July 2018)
[2] Written Evidence from John Stone (Age of Autism), House of Commons Health Social Care Committee, Inquiry into Anti-Microbial Resistance, http://data.parliament.uk/writtenevidence/committeeevidence.svc/evidence...
Competing interests: No competing interests
Based on my experience as a GP and Clinical Director, I was appointed as an independent Director of Fife Sport and Leisure Trust Limited SC039464 when it was set up 10 years ago. The Trust is a Scottish Charity which manages the staffing and services provided in Fife Council sport centres. The management fee paid by Fife Council to Fife Sport and Leisure Trust has reduced from £8m to just over £2m but despite this we have increased attendances, increased services and increased our range of classes. The cost of this has been payed by the users and by efficiencies made by staff. We now have fees and charges at the higher end of the scale compared to other Sport and Leisure Trusts in Scotland.
NHS Fife had provided half the cost of a post to coordinate the running of phase 4 cardiac rehabilitation in our centres (the rest was included in the management fee from Fife Council) but withdrew this funding shortly after the Trust was set up. The Trust continued to employ the post holder and she developed an extension of cardiac rehabilitation which is marketed as Active Options 2 which is heavily subsidised by the trust. (1)
We receive no funding from NHS Fife, although we do get some additional funding from Fife Council towards our inclusion projects.
The Trust also secured funding from MacMillan towards the cost of providing free classes for people with or recovering from cancer which was marketed under the Move More Fife banner. Classes for both Active Options 2 and Move More Fife are provided in centres across Fife including at the Maggie's Centre in Kirkcaldy.
Unfortunately, with further cuts in our management fee we are faced with a £470,000 deficit in this financial year which leaves us with alternatives of
1) Increase fees and charges further and risk excluding those who cannot afford to pay and reduce attendances
2) Close unprofitable centres which are in areas of deprivation
2) Reduce opening hours
3) Stop services such as Active Options 2 which is heavily subsidised.
In 2012-13 NHS Fife spent approximately £6m on lipid modifying drugs and £2.5m on oral diabetes drugs - I would assume that these figures have increased.
Whilst we do get a lot of referrals from Health Care staff it is patchy and many users report that they were not told about our classes or were given a very poor view of what we provide.
So the NHS may "talk the talk" regarding prevention and rehabilitation but my experience is that we are a long way from "walking the walk".
Thank you for raising the profile of lifestyle in the BMJ.
Competing interests: No competing interests
Dr Godlee is right that we face the appalling prospect of filling everyone full of pills for 'lifestyle disorders' (https://www.bmj.com/content/bmj/362/bmj.k3046.full.pdf ). I have one caution, and also a solution. Both will be contentious.
The caution relates to the new 2017 ACC/AHA guidelines for hypertension that would have us ultimately prescribe anti-hypertensive agents to almost all adults. These guidelines have caused consternation and disarray. Sensible clinicians are justifiably concerned that the changed definition of high blood pressure will result in drug-related renal injury and falls—and increased costs with few or no benefits. What we have perhaps failed to appreciate is the underlying strategy being used to amplify profits. This is a generic strategy that has been used before, to horrifying effect.
The strategy might be described as "selective amplification of reported results". The epitome of this approach was selective, repeated citation of one small letter to the Editor of the New England Journal, as part of a strategy to amplify the use of modified release opiates (cited 608 times, https://www.nejm.org/doi/full/10.1056/NEJMc1700150 ). Its success has been evident both in the harm caused—opiate-related deaths now exceed both firearm-related deaths and road traffic crash deaths in the USA—and in drug company profits. Amplification of selected results drove highly inappropriate use of medication for a chronic disease.
This is happening again, with selective amplification of the results of the SPRINT study, which appears to be the main driver for the new hypertension guidelines. Many clinicians are unaware that 90% of patients in this trial had already received a diagnosis of hypertension under the old criteria ( https://www.acc.org/latest-in-cardiology/articles/2015/12/01/10/04/the-s... )—surely a fatal flaw on its own. There is little or no other motivation for classifying a systolic blood pressure over 120 as 'elevated', and all previous results, including the ACCORD trial ( https://www.nejm.org/doi/full/10.1056/NEJMoa1001286#t=article ) do not support the new guidelines. We are being hoodwinked by marketing forces for purposes of profit—again.
Pills are not the solution here, but we also need to look more broadly if we are to find effective solutions for actual "lifestyle" disorders. The responsibility for fixing these is often laid at the door of the individual, but like doctors deceived by bad guidelines, patients with these disorders are often impotent in the face of their environment.
Lifestyle disorders are related to dosing of communities with commodities such as high-energy-density carbohydrates, salt, alcohol, nicotine, and even opiates (as noted above). Solutions will be ineffective unless they address this by (1) limiting advertising—especially selective use of misleading data; (2) decreasing distribution points; and (3) increasing price. These are all unappetising options for those invested in healthy profits rather than healthy communities.
The ultimate naiveté is however to imagine that spending just a few hundreds of millions of pounds on promoting healthy lifestyle will counteract the billions currently spent on promoting and embedding just the opposite. To fix things, interventions need to be realistic.
My 2c.
Competing interests: No competing interests
Pills are not the answer to unhealthy lifestyles but maybe nutrition and physical exercise advises aren't either (sort of victim blaming [1] "I eat a lot and too few vegetables and I move too little"), and privatizing the solution to an individual level being a public health issue that maybe needs a communitarian approach [2]).
Social determinants of health must lead our understanding of social inequalities BEFORE applying a patient-centered approach [3]. There is no use (or worst, there is a misuse of) shared-decision making if we (physicians, nutritionists, nurses...) support our speech or address issues like obesity, type 2 diabetes mellitus, hypertension... on the calories-in calories-out basis. Even if this view was objectively true (at describing cause and effect), we see day after day a non-random distribution of this health problems. Athina Raftopoulou (her thesis is coming. Maybe at the end of 2018 we could take a look on it) analysed the geographic determinants of individual obesity risk in Spain [4]:
-"[...] controlling not only for the individual effects and those of the immediate environment but also for the broader setting to which individuals and their immediate environment belong"; she found that "[...] attributes from all three levels of analysis have an effect on individual weight status and obesity. Lack of green spaces and criminality taken as proxies of the social environment positively affect individual and women's BMI and obesity, respectively". Asymmetric incidence of obesity driven by sex and socioeconomical status are not new topics (or should not be to us).
Michael Marmot said in 2005 [5] that:
-"[...] If the remedies of the social causes of health should be social, what should we do? I am now up to my ears in a new Commission on Social Determinants of Health [3]". Their team and he "[...] are trying to take a social approach to reducing inequalities in health between and within countries". It is (in my point of view) less unfair in this way indifferent of the option applied at the end (pill or other treatment).
Saibal Mitra [6] wrote:
-"[...] We need to consider new ways of effecting lifestyle change. A possible solution is to exploit the fact that poor lifestyle choices cost society a lot of money. This is an additional problem that can, however, be used to finance interventions that promote lifestyle changes. E.g. one can consider implementing a free of charge healthy food ration system"
Why? Well because Nicole Darmon and Adam Drewnowski studied whether social class predicts diet quality [7] (Table 1, Table 2, and Figure 1 are of special interest for me). Interesting findings:
-"[...] it is possible to purchase an energy-dense diet for a relatively high cost, while economic constraints will necessarily increase energy density. In other words, the more affluent groups have a choice of high-energy-density or low-energy-density diets, whereas for low-SES groups, the ability to adopt a healthier diet may have less to do with motivation than with economic means. Recent studies from both the United Kingdom (194) and the United States (195) have shown that providing vouchers for purchasing fruit and vegetables was a simple and effective way of increasing fruit and vegetables intakes in low-income women, whereas dietary advice alone had no great effect (194)."
Let me repeat their statement: dietary advice alone had no great effect (maybe hard to read for a nutritionist. I had my doubts too in my second year bachelor's degree about it). I repeat my initial statement: pills are not the answer to unhealthy lifestyles, but maybe nutrition isn't either (alone or / and without a perspective of social determinants of health).
I don't know what is the answer to unhealthy lifestyles. But I am sure we can do better managing our actions in this uncertainty. We can't prescribe money yet [8] but we can (and must) recognize patterns of injustice in the lifestyle of the communities (not only just focusing on the individuals in an isolated way). For example, sociocultural and socioeconomic influences on Type 2 Diabetes Mellitus risk in African-American and Latino-American children and adolescents [9], gender inequalities [10], and asking ourselves if the problem is obesity or difficulties in making ends meet [11].
Maybe there is no (simple and reductionist) answer at the end. But we must watch very carefully how we look for it.
References:
[1]: https://www.theatlantic.com/science/archive/2016/10/the-psychology-of-vi...
[2]: Ataguba JE, Mooney G. A communitarian approach to public health. Health Care Anal. 2011 Jun;19(2):154-64
[3]: Lang T. Ignoring social factors in clinical decision rules: a contribution to health inequalities? Eur J Public Health. 2005 Oct;15(5):441
[4]: Raftopoulou A. Geographic determinants of individual obesity risk in Spain: A multilevel approach. Econ Hum Biol. 2017 Feb;24:185-193
[5]: Marmot M. Historical perspective: the social determinants of disease--some blossoms. Epidemiol Perspect Innov. 2005 Jun 2;2:4
[6]: https://www.bmj.com/content/362/bmj.k3046/rr-2
[7]: Darmon N, Drewnowski A. Does social class predict diet quality? Am J Clin Nutr. 2008 May;87(5):1107-17
[8]: https://www.youtube.com/watch?v=FLRT0bvaz98
[9]: Rebecca E. Hasson, Tanja C. Adam, Jay Pearson, Jaimie N. Davis, Donna Spruijt-Metz, and Michael I. Goran, “Sociocultural and Socioeconomic Influences on Type 2 Diabetes Risk in Overweight/Obese African-American and Latino-American Children and Adolescents,” Journal of Obesity, vol. 2013, Article ID 512914, 9 pages, 2013
[10]: Sandín-Vázquez, María & Espelt, Albert & Escolar Pujolar, Antonio & Arriola, Larraitz & Larrañaga, Isabel. (2011). Desigualdades de género y diabetes mellitus tipo 2: La importancia de la diferencia. Avances en Diabetología. 27. 78–87.
[11]: Escolar Pujolar A. [Social determinants vs. lifestyle in type 2 diabetes mellitus in Andalusia (Spain): difficulty in making ends meet or obesity?]. Gac Sanit. 2009 Sep-Oct;23(5):427-32
Competing interests: No competing interests
Is what we've been saying for years. How let down by my medical training did I feel when I realised. All about being the ambulance at the bottom of the cliff rather than fence at the top, and the medical environment is still all set up to be like this. Money talks and determines a lot of this, there's very little money in promoting broccoli as I have realised, but it's much more effective.
Put money towards prevention and group sessions, set legislation for high fat foods and sugars (remember fats and oils are 9/4 times moreover calorific then sugar and every more processed/ refined, including olive oil, and legislation to facilitate healthy lifestyles. My standard work as a GP is tedious pill prescribing by numbers, easy but boring and now I know you can reverse diabetes, heart disease, inflammatory conditions, halt many cancer growths (Stop feeding your cancer -dr John Kelly), the prescribing work feels ridiculous. Like mopping up the floor but not turning the tap off it's coming from.
Prevention/ lifestyle therapies are the way forward for most conditions, let's promote it first.
Dietary wise this has been proven to be done by a whole foods, plant based diet, which is also the optimal diet for preventing cimate change. There is absolutely no point in being relatively healthy if theres going to be no where to live. Please write more on diet and effects on the environment, and not put head in the sand BMj when discussing this.
Competing interests: No competing interests
Promoting lifestyle changes has not worked well enough to turn the tide. We need to consider new ways of effecting lifestyle change. A possible solution is to exploit the fact that poor lifestyle choices cost society a lot of money. This is an additional problem that can, however, be used to finance interventions that promote lifestyle changes. E.g. one can consider implementing a free of charge healthy food ration system.
Suppose that everyone gets an electronic card that can be used to get a free of charge ration of fruits and vegetables from the supermarket. The supermarkets will then get paid by the government. The moment something is made free of charge, people will take it home. Not everyone will end up eating the free of charge fruits and vegetables, however, it is very likely that a large fraction of the population would start to eat a lot healthier, particularly the poorer part of the population who tend to make unhealthy lifestyle choices.
The power of healthy eating and exercise can hardly be exaggerated. Take e.g the fact that cardiovascular disease is virtually non-existent in societies that are primarily plant based. In [1] this has been rigorously verified in the Tsimane of Bolivia by measuring CAC using mobile CT scanners. But there were a lot of hints of this fact from older evidence, see e.g. [2]. So, by pushing society to take step in this direction, massive savings in healthcare expenditures are possible. The cost of giving people free of charge fruits and vegetables will pale in comparison with the savings. Here we need to note that since everyone needs to eat anyway, the costs come from the price difference between healthy foods and unhealthy foods, increased food waste (people taking the free of charge items but not eating them), the cost of running the electronic card system etc.
References
[1] H. Kaplan, R. C. Thompson, et al., Coronary atherosclerosis in indigenous South American Tsimane: a cross-sectional cohort study, The Lancet 389, 1730-1739 (2017).
[2] A.G. Shaper, K.W. Jones, Serum-cholesterol, diet, and coronary heart-disease in Africans and Asians in Uganda, The Lancet, 534–537 (1959).
Competing interests: No competing interests
Prima facie so true. Reversibiity through lifestyle measures in components of metabolic syndrome has been not just a good news , but one offering both hope and promise. But the stark reality of environmental surrounding culture ensure that the wide choices of indulgence and consumption may indeed be tempting and overriding .Most people may appear to be victims of consumer wave , albeit with difference of degree. The neurobiological basis of human behaviour is complex with 'learning ' being different from 'conditioning'. All out efforts towards healthy lifestyle is a continuous exercise on a sustained basis , with results that may be mixed. Not confined to a single pill , with the clustering of risk factors and coexistence of disease conditions , 'polypill ' is also in use. Yet , pill may appear to be a reluctant second choice in substantial numbers. Dr Murar Yeolekar. , Mumbai.
Competing interests: No competing interests
Healthy Lifestyles can Delay your Pills Dependent state.
Pills or surgery are not a answer for obesity. Patches of nicotine or pellets are not a remedy for smoking or tobacco use. Statins are not the cure for atherosclerosis . Antidepressants or anxiolytic are not the only treatment for stress.
Drugs are not only the treatment for Non communicable disesses such as stroke heart attack COPD cancers diabetes including hypertension.
More than drugs , healthy diet, healthy environments, healthy habits and stress free state are also the corner stones for healthy lifestyles and it keeps you away from lifestyles diseases.
Healthy lifestyles can also delay the periods for the initiation of drug treatment in diseased state and it can also delay the early pills dependent health state.
Healthy lifestyles may also delay the early development of many age related diseases.
Competing interests: No competing interests
Re: Pills are not the answer to unhealthy lifestyles
John Stone draws attention to the concern of MEPs that restoring public confidence in vaccination depends, in the minds of MEPS, on there being “ ..increased transparency in evaluating vaccines and their adjuvants .. “
Such an ongoing programme of evaluation and surveillance should have begun in the USA more than 30 years ago.
“In 1986, Congress charged Health and Human Services (HHS) with the primary responsibility of ensuring vaccine safety after removing product liability from vaccine manufacturers as part of the National Childhood Vaccine Injury Compensation Act. As part of the 1986 Act, HHS is required to create a task force and submit bi-annual reports to Congress detailing actions taken to ensure vaccine safety. “ (1)
The reluctance of the US Department of Health and Human Services (HHS) to explain to the Informed Consent Action Network (ICAN) how it had discharged those responsibilities, led to a recent case in the US District Court, when HHS finally revealed that it had no record of performing any evaluation nor surveillance of vaccines, in the thirty years since that duty was imposed on it by the US Congress. (2)
As the vaccine industry in the USA has been free from product liability since 1986, the industry may not have been especially motivated to conduct it’s own safety studies. This possibility is made more likely by the many references supplied by Moskowitz, in his chapter on the safety of vaccines. (3)
Those who are enthusiasts for the present UK vaccine schedule often inform our profession and the public that vaccines are “ safe”. We are never told exactly how safe, and this recent USA District Court disclosure is not reassuring in that respect.
1 http://icandecide.org/government/
2 US District Court, Southern District of New York.
http://icandecide.org/government/ICAN-HHS-Stipulated-Order-July-2018.pdf
3 Richard Moskowitz. Vaccines , a reappraisal. Skyhorse. 2017.
Competing interests: No competing interests