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Sepsis “hysteria” – it’s not just a matter of life and death.

The former manager of Liverpool FC, the one and only Bill Shankly once said “Some people believe football is a matter of life and death, I am very disappointed with that attitude. I can assure you it is much, much more important than that.” Shankly was a tremendously successful manager and laid the foundations of even more success for Liverpool for the managers that followed him after his retirement. Recently, a letter was published on the website of “The Lancet” by a group of eminent doctors with vast experience in research, acute medicine and critical care, caring for sepsis patients. The Lancet is one of the oldest, best known and most prestigious medical journals, one of the few medical journals that’s known to members of the general public. In recent years, it’s also attracted a significant amount of adverse publicity through controversies, perhaps most notably the publication of former doctor Andrew Wakefield’s infamous paper purporting a link between the MMR vaccine and the development of autism. The paper was eventually retracted when it was shown that Wakefield had committed research fraud of such a serious nature that he was stripped of his medical licence and struck off the GMC’s medical register. Now is not the time and this is not the place to go into further detail about the severe consequences of Wakefield’s fraud. While in no way suggesting that the reason to write this letter was in any way connected to any ulterior motives, it nevertheless caused a great deal of upset and distress to sepsis survivors damaged by their encounter with this often devastating illness and also to those bereaved by sepsis, particularly when the death of their loved one was in the group of sepsis deaths that should have been avoidable. It was – at best – unfortunate that the Health Secretary for England posted his tweet about each sepsis death being “a preventable tragedy” as it’s clearly not possible to prevent every death from sepsis, even with rapid recognition, diagnosis and treatment. Whether he wrote that tweet himself or it was written by a member of his office staff we may never know. Nevertheless, the wording suggests that whoever wrote it has misunderstood the information on which the tweet was based. This was unprofessional.
Sepsis as a condition has been described since at least the 4th century BCE by Hippocrates, but in terms of disease the word “sepsis” came into use sometime in the 19th century CE. When I went to medical school in the early 1980’s, the word “sepsis” wasn’t used a great deal but would be used to describe various infections such as “chest sepsis”, “intra-abdominal sepsis” or “urosepsis”, with the more severe manifestations of hypotension and organ failures being termed “septicaemia” or even “septicaemic shock”,  with the term “septic shock” also occasionally thrown around. There was no official definition, but when you saw a patient with septic shock you knew what it was and that it was BAD! It wasn’t until the publication of what can now be termed “Sepsis 1.0” in 1992 based on the criteria laid out by Bone et al in Chest, Volume 101, Issue 6, June 1992, Pages 1644-55 that there were official definitions of sepsis, severe sepsis, septic shock and multiple organ dysfunction syndrome. Finally, a common language for sepsis was available. However, it soon became apparent that these definitions and, in particular, the the reliance on the use of the Systemic Inflammatory Response Syndrome (SIRS), were not sufficiently robust, so attempts to review and revise the definitions were made. In February 2016, The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) were published in the Journal of The American Medical Association. These definitions are a significant improvement on what went before, describing sepsis as  “life-threatening organ dysfunction caused by a dysregulated  host response to infection”. As definitions go, this is excellent. It describes the key features of sepsis being the response to an infection when that response has gone haywire, resulting in organ dysfunction(s) that leads to organ failure(s) and can be fatal.

Running alongside these definitions and their revisions has been a great deal of work to understand the magnitude of the problem of sepsis and thereby to improve outcomes. Sepsis was (and still is) a condition in which the mortality rate is very high. With the Sepsis-3 definitions, sepsis is ascribed a mortality rate of 10% and septic shock a mortality rate of 40%. This high mortality rate has been appreciated for many years.
The first scientific publication to address this in any meaningful way was the paper by Rivers et al in the New England Journal of Medicine, November 2001, “Early goal-directed therapy in the treatment of severe sepsis and septic shock” . While the concepts of early goal-directed therapy have not stood further scrutiny, that maybe because this paper was seminal in beginning the Surviving Sepsis Campaign, leading to a focus on early recognition, diagnosis and treatment of sepsis. By the time the results of the ARISE, ProCESS and ProMISe trials were published, it may have been that “usual care” for sepsis had improved such that a strict focus on therapeutic targets (which themselves attracted criticism) offered no advantages over what had become conventional therapy with early intervention, particularly with early, broad-spectrum antibiotics. A major criticism of the Surviving Sepsis Campaign (SSC) was that the elements of the care bundles required for compliance were difficult enough to complete within an ICU and practically impossible outside of an ICU. A simplified approach – the Sepsis Six – was developed by Dr. Ron Daniels et al from the SSC guidelines as a more practical way of delivering key elements (oxygen, intravenous fluids and antibiotics) in non-ICU settings. This showed that treating sepsis patients quickly had a significant impact on reducing the mortality rate from sepsis. Having a fairly simple care bundle for sepsis that seems to work in all circumstances now meant that healthcare professionals couldn’t regard sepsis as being “too difficult” to make improvements upon. Thus was born the “Survive Sepsis” campaign which would later morph into the United Kingdom Sepsis Trust in 2012, headed by Ron Daniels. Also, in 2010, the Global Sepsis Alliance was established, which set about improving sepsis care internationally and created World Sepsis Day, which has been held on September 13th each year since 2012. In May 2017, the World Health Organisation issued Resolution A70/13 “Improving the prevention, diagnosis and clinical management of sepsis“. Thus in a time-frame of of just 16 years, there’s been a major change in terms of the recognition of sepsis as being just a difficult, serious and severe illness with a high mortality rate, moving forward to a recognition that early diagnosis and treatment can be life- and limb-saving. The are now many organisations across the world – professional, charitable and governmental – pushing the agenda of early sepsis diagnosis and treatment, including in some parts of the world mandatory screening for sepsis in acute admissions and reporting to governments of compliance with sepsis screening and timely delivery of sepsis treatment bundles.

As sepsis has risen up the healthcare agendas across the world, public understanding of the word “sepsis” has increased greatly. The pressure to make that early sepsis diagnosis and treatment has ramped up significantly. This is where significant, justifiable concerns have been raised, particularly because the therapy most likely to be life-saving is early administration of broad-spectrum intravenous antibiotics, ideally in less than one hour from the onset of sepsis symptoms (i.e. not just the symptoms of infection, but the systemic symptoms). Initially, this requirement for early antibiotic therapy was based on the seminal paper on the relationship between the duration of hypotension in septic shock prior to antibiotic treatment and mortality by Kumar et al in “Critical Care Medicine” in 2006. However, as this paper only looked at patients with septic shock, that early antibiotic treatment element was rebutted by many. There have been several studies looking at the effectiveness of early antibiotics in non-shock sepsis, with mixed results. In May 2017, a paper was published from New York State Department of Health on “Time to Treatment and Mortality during Mandated Emergency Care for Sepsis“. This paper showed that mortality from sepsis, with or without shock, was adversely impacted by delays in treatment. Overall, it is my impression (without a formal meta-analysis) that the evidence favours early antibiotic treatment in sepsis.

At this point, it is entirely reasonable to be concerned about the potential over-use of antibiotics, particularly broad-spectrum antibiotics. Questions are – reasonably – asked as to whether the emphasis on early sepsis treatment is detracting from the recognition, diagnosis and treatment of other acute illnesses. Not every acute illness is sepsis and not every case of infection leads to sepsis. Indeed, only a very small percentage of infections lead to sepsis and an even smaller percentage lead to septic shock. Simple infections may or may not need antibiotic treatment and almost certainly treatment can wait at least until diagnostic specimens are obtained and even until the results of cultures are reported. Saying this, however, fails to recognise that despite the fact that sepsis is a rare complication of infection, it is still a major killer worldwide, with an estimation that sepsis kills someone in the world every 3.5 seconds or between 6 and 9 million deaths each year out of a total of 27 – 30 million episodes of sepsis. In the UK, the most recent estimates (based on data sources such as clinical coding) are that there are over 260,000 cases of sepsis/septic shock and approximately 52,000 deaths. This death total is more than the death total from lung cancer, the UK’s single-biggest cancer killer. It’s more than the combined total number of deaths from the breast, bowel and prostate cancers plus road traffic deaths plus HIV deaths. Now, this is where the push for early recognition and treatment of sepsis is amenable to challenge and was termed “Sepsis hysteria” in that Lancet letter. The authors refer to a paper published by Kopczynska et al, based on data collected for the Welsh annual point-prevalence studies “Defining Sepsis on the Wards” (formerly the Size of Sepsis in Wales) – I am a Principal Investigator for these studies, though not involved in writing this particular paper. The paper on attributable mortality fraction showed that the majority of sepsis-associated deaths are in patients with significant levels of clinical frailty and/or comorbidities. However, the counterpoint to this is that there are still many deaths directly attributable to, or at least with a significant contribution from, sepsis – approximately 24% in this data from Wales. This correlates with what is seen in clinical practice. For example, an elderly, frail patient who develops pneumonia which is then complicated by hypoxia, hypotension and acute kidney injury despite treatment with intravenous fluids and antibiotics. It may well be completely appropriate not to escalate therapy in a patient like this – an example of what Osler termed “the old man’s friend“. A lot has changed since Osler’s times, but nevertheless a chest infection may be the terminal event for an frail, elderly person with significant comorbidities. On the other hand, however, we also see patients who fit into the 24% of those who’s deaths are entirely due to, or at least with a significant contribution from, sepsis. We see young, fit, healthy adults in intensive care with septic shock and dying as a consequence – people like Rachel Day. We see children such as William Mead (died after multiple missed opportunities to intervene) and Chloe Christopher (died as a consequence of a lack of understanding that her symptoms had become so severe as to merit immediate hospital). This percentage of deaths seen in our Welsh data closely matches the claim made by the UK Sepsis Trust of about one-quarter of sepsis deaths being preventable.
Even accounting for the around 14,000 missed opportunities to prevent a sepsis death, this still fails to account for many sepsis survivors who are left with a variety of life-changing and life-limiting consequences of sepsis. A rough calculation based on the best current available data gives a figure of over 200,000 sepsis survivors. Studies suggest that perhaps up to 25% of sepsis survivors are left with these significant consequences. People such as Jayne Carpenter, Tom Ray, John James and Angela Burns. Children such as Sam Howells. Sepsis survivors face a wide variety of issues with physical problems, psychological problems, high rates of hospital readmission and a mortality rate in excess of the general population. Surviving an episode of sepsis may well not be the end of the matter. We have some information on possible explanations for these ongoing problems, we don’t have enough data on whether these problems can be prevented, or at least ameliorated, by timely treatment with antibiotics. However, it’s not unreasonable to surmise that early treatment may well have benefits in terms of reducing morbidity from sepsis based on the putative causative mechanisms.
The major problem is, therefore, that when a patient presents suffers an acute deterioration in health, the publicity given to diagnosing and treating sepsis can mean that healthcare professionals may become all-too-willing to label all acute deterioration as sepsis, with the response being to unthinkingly use the Sepsis Six bundle. This means that patients may be exposed acutely to harm from inappropriate administration of intravenous fluids and antibiotics and undergo unnecessary urinary catheterisation. Inappropriate use of antibiotics is helping fuel growth in antimicrobial resistance – a catastrophe in the making. GPs will, understandably, be concerned about striking a balance between failing to give antibiotics for life-threatening infections such as meningococcal disease while simultaneously balancing the demands on them to keep control on prescribing budgets and their professional obligations in regard to antimicrobial stewardship. GPs don’t usually have rapid access to the various investigations that secondary care providers can carry out, so it would not be fair to criticise them for giving antibiotics to a patient they suspect of developing sepsis – it could be a life- or limb-saving intervention. When a patient arrives acutely unwell at a hospital or deteriorates while in hospital, considering the possibility that this acute illness might be sepsis is entirely reasonable but clinicians have been trained to think, take a history, perform physical examination, order investigations and interpret the results in order to formulate a diagnosis and then to prescribe and administer appropriate therapies. One of the processes they can go through to help in the diagnostic process is to use a sepsis screening tool. In the UK, the National Institute for Health and Care Excellence published its national guidance, NG51, in July 2016, including algorithms for risk stratification of patients in various age groups and types into low, medium and high risk categories. It is only those patients who can be categorised as high risk who should receive the Sepsis Six bundle within one hour of presentation. All other patients should undergo assessment and investigations to decide whether an infection is present and whether there is evidence of end-organ dysfunction that should be treated as sepsis. Key to this process is the involvement of senior clinicians early in the diagnostic process, who can ensure that the process is appropriately rigorous and can review therapeutic choices, stopping inappropriately prescribed antibiotics or even prescribing them when they should have been in the first place.
One major issue identified with sepsis identification and treatment is a failure to identify infecting organisms with only a little over 40% of patients with sepsis having any sort of positive culture. A frequent reason for failing to obtain positive culture results is not actually taking the cultures in the first place. It cannot be emphasised enough that in order to prescribe antibiotics rationally and reduce the inappropriate use of broad-spectrum antibiotics is to take blood and other relevant culture specimens, review the results as soon as they become available and practice good antimicrobial stewardship. This week is World Antibiotic Awareness Week, with an emphasis on antimicrobial stewardship. In the UK, we should routinely follow the principles embodied in Start Smart Then Focus but in reality this isn’t rigorously practiced. Employing sepsis teams and antimicrobial pharmacists can help reduce the use of broad-spectrum antibiotics, but it should be the job of all clinicians to practice good antimicrobial stewardship.
I think the authors of that letter in The Lancet may have aimed to be controversial in order to make the point that not all acute deterioration is due to sepsis, but in doing so the backlash may have damaged their own case. It’s not hysteria to want to not miss a diagnosis of sepsis, because the consequences may be extremely severe, even fatal. While many of the deaths are unavoidable, it’s not just a matter of life and death in sepsis – it’s far more than that. Better recognition, diagnosis and treatment of acute deterioration, improving antimicrobial stewardship and better support for sepsis survivors all need to be considered.

Sepsis Seminar for World Sepsis Day

Just to say that there will be a Sepsis Seminar held on Wednesday, 13th September 2017 at the University Hospital of Wales, Cardiff. It’s for staff and students of the Cardiff and Vale UHB and Cardiff University, but staff from the Welsh Ambulance Service and other learning establishments affiliated with the UHB and Cardiff University are all welcome. It’s free to attend and no registration is required – just turn up!

Does homeopathy have any role in the treatment of sepsis?

Ok, this could be just a single word answer – no. However, let’s look at this with a critical eye and examine the available evidence. A PubMed search using the term “homeopathy sepsis” yields just 14 results. Ok, not a great start for the homeopaths and their acolytes. A review of the results reveals that just one of those 14 results is any sort of clinical trial of homeopathy in sepsis. That paper is entitled “Adjunctive homeopathic treatment in patients with severe sepsis: a randomized, double-blind, placebo-controlled trial in an intensive care unit.” It was published in the journal “Homeopathy” in April 2005, a journal published by Elsevier.

My attention has been drawn to this paper on several occasions by homeopaths and homeopathy “fans” who claim that it provides incontrovertible evidence that homeopathy is of benefit in sepsis. This includes the likes of Dana Ullman (aka @HomeopathicDana on Twitter), John Benneth (@JBennethJournal), Steve Scrutton (@stevescrutton) and Sandra Hermann-Courtney (@BrownBagPantry). Interestingly, Ullman and Benneth both feature on the blog site “Encyclopedia of American Loons“. Dana Ullman is here and John Benneth is here. Hermann-Courtney has a second blog site where she talks about how she blocks homeopathy skeptics – the internet equivalent of being an ostrich putting her head in the sand as the cognitive dissonance is too much for her to bear. Meanwhile, Scrutton has fallen foul of the UK’s Advertising Standards Authority here and here. Many people have written about his antics and indeed elsewhere on this blog site you can read about my own “interesting” encounter with him here.

So I decided to critically appraise the paper to see if the claims made stand up to scrutiny.

The authors of this paper are listed as “M Frass, M Linkesch, S Banyai, G Resch, C Dielacher, T Lobl, C Endler, M Haidvogl, I Muchitsch and E Schuster”. The lead author is no less than Professor Michael Frass. In this paper, his place of work is listed as “Ludwig Boltzmann Institute for Homeopathy, Graz, Austria”.  He held the post of Director of this institute from 2002 until 2005. Subsequently, he became president of the Institute for Homeopathic Research. However, he’s also known as a Professor at the Medical University of Vienna, Austria. Frass has written papers on various subjects related to atrial natriuretic peptide in ventilated patients and he is the inventor of an emergency airway device called the Combitube, which was popular for a while in situations where endotracheal intubation was difficult. (Subsequently the laryngeal mask airway and variants such as the iGel have become better known).

Given his clear links with institutes that support and promote homeopathy, it’s no surprise that Frass might be involved with clinical trials of homeopathy. It’s less clear as to why a clinical trial would be conducted in an ICU setting as he doesn’t seem to have any particular connection to the specialty of Intensive Care Medicine. He would seem to be the director of a homeopathy outpatient clinic and to work in the Division of Oncology at the Department of Medicine I in Vienna. Hmmm! Ok, so his credentials for conducting a clinical trial in an ICU seems somewhat underwhelming, but it may be that he has a reasonable background in clinical research that might be applicable. So, I won’t write him off as not being suitable for conducting research in the field of Intensive Care Medicine (ICM), particularly as it seems he did write papers on atrial natriuretic peptide as mentioned earlier. A PubMed search for “Frass M” yields 199 hits. How many of these are clinical trials and how many are related to ICM? Trawling through the results finds, as expected, a fair number of results relating to airway management devices but just a few articles relating to sepsis, but no clinical trials in sepsis. Changing the search term to “Frass M sepsis” narrows the search to just 17 articles. Apart from the trial I will critique in due course, the only other publication which relates to a sepsis clinical trial is a pilot study of a Protein C concentrate, which was published in 2006 (Frass was 5th author). I think, therefore, it would be fair to describe his research background relevant to sepsis as “limited”.

Now, let’s move on to the paper itself. I’m going to compare it against the CONSORT criteria for reporting a clinical randomised controlled trial (RCT). These criteria were described in 2010 while the paper was published in 2005, but they nevertheless make a good way to assess a paper reporting the results of an RCT.

The CONSORT criteria ask a series of questions so let’s go through them in regard to this paper:-

Title and abstract:-

1a Does the title identify the study as being a randomised trial? Yes, the title clearly states this.

1b Is the abstract a structured summary of trial design, methods, results, and conclusions? Yes, this conforms to the CONSORT standards

Introduction :-

2a Does the introduction describe the study background and objectives? Is there a description of the scientific background and explanation of rationale? No. The abstract gives a brief summary of (severe) sepsis incidence and mortality and of some therapies that have been unsuccessfully trialled. It then claims that homeopathy has been shown to be superior to placebo in studies (ignoring the quality and published meta-analyses) and that it has an effect in “high dilutions, even beyond Avogadro’s number”. Here we have a problem – the evidence to support these claims doesn’t bear up to critical appraisal and the concept of a substance exerting an effect when serially diluted (a fundamental tenet of homeopathy – the “law” of infinitesimals). We have, therefore an issue with “prior plausibility“.

2b Is there a description of the specific objectives or hypotheses? Yes, the study objective is stated – to evaluate the effect on outcome of homeopathy on patients with severe sepsis at 30 and 180 days. Here we have another issue with this study. While a 30 day mortality is a standard end-point for clinical trials in Intensive Care and sepsis, no sepsis trials consider 180 day mortality as a reasonable end-point, as there are too many confounding factors that can influence mortality the further out from the time of the trial intervention. We see similar issues when we look at registries of outcomes in other areas of healthcare, for instance the MBRRACE-UK (formerly CEMACH) series of audits of maternal deaths, where any death for up to one year after childbirth is recorded as a “maternal death”, even if (for example) the death was the result of a car crash. Of course, the key is in the interpretation of the data. Recently, 3 large multi-centre trials (ProMISe, ARISE and ProCESS) on early goal-directed therapy in sepsis reported mortality at either 60 or 90 days.

We’ll look at the data in due course.


3a Is there an adequate description of the trial design (such as parallel, factorial) including allocation ratio? Yes, there is a very reasonable description of the trial design. It clearly states that it received the necessary ethical approval and consent process. It describes the eligibility criteria and the randomisation process, which both seem appropriate. It describes the data to be collected and the statistical analysis process.

So far, so good!

That is, until we consider the sample size for the trial. To compare treatments in a clinical trial, you need to know what the baseline outcome frequency is and you also need to assess how big a difference in outcome would be regarded as a worthwhile improvement to consider the new tested therapy as providing a meaningful benefit. For example, if you decide to study the effect of a new treatment on a disease which is always fatal, then if the new treatment results in any survival, you might say that it’s a worthwhile benefit. On the other hand, if the disease typically results in a 50% mortality, you may consider that a 10% (i.e a 45% mortality rate) or a 20% (40% mortality rate) improvement in survival rates is acceptable. While the authors give generalised mortality figures, the range quoted is from 40% to 90% for their target patient group. This, however, makes no reference to their own local outcome data. Hmm. With this in mind, how did they decide what an appropriate sample size would be in order to show an acceptable clinically and statistically significant improvement in mortality rate for the treatment arm patients?

They didn’t.

Oh dear!

Let’s try to help here. In the UK, mortality rates from severe sepsis and septic shock vary across the country, but recent data from the HSCIC and Welsh Government gives a mortality rate of 30% in England and 24% in Wales. (Yes, Jeremy Hunt and David Cameron, just one example of how NHS Wales isn’t a second class service as you so frequently lie about). We’ll, perhaps generously, assume that the 30 day mortality rate of the study control arm represents a true mortality rate for patients with severe sepsis in their ICU. We’ll ignore the 180 day mortality figures for the reasons explained above. The paper gives us a control arm mortality rate of 32.3% –  fairly reasonable for the time at which this study was conducted. With no attempt by the authors to consider what would represent an acceptable clinically and statistically significant improvement in mortality rate for the treatment arm patients, I’ll have to make some assumptions to try to work out how big a sample size is needed to see if such an improvement is both clinically and statistically significant. As a rough guide, in the PROWESS trial for activated Protein C in severe sepsis (now debunked and the product withdrawn following the PROWESS SHOCK trial), the treatment arm mortality rate was 24.7% as compared to 30.8% in the control placebo arm. This was approximately a 20% relative risk reduction and a 6.1 % absolute risk reduction. Let’s therefore calculate, on that basis in the Frass trial, what size patient population would be needed if a 20% relative risk reduction was to be achieved with a reasonable degree of certainty. In other words, we need to perform a power calculation to see whether the required change in outcome could be shown in the trial with a reasonable certainty that the trial result is both likely to be genuine and statistically significant. Without getting too deep into this and the statistics behind sampling errors and statistical significance (you can read an article from the North Bristol NHS Trust’s Research and Innovation Department here), we are fortunate in that we can readily obtain the sample sizes required at the levels required using calculators freely available on the Internet. Given that we’re looking at a baseline mortality in this paper – which isn’t far off that seen in the PROWESS study – let’s work on the basis that a 20% reduction in mortality would have been regarded as an acceptable, clinically significant end-point. In other words, we’re looking for the “treatment” to improve mortality from it’s baseline of 32.3% to 25.8%. We can now use an online calculator to work out a sample size for the study which would have had adequate power to detect that 20% relative risk reduction. We’re looking at what is described as a “binary outcome” – the patient is either alive or dead at the end of the study period. Now the appropriate way to design a clinical study is to aim to compare the “null hypothesis” (i.e. the treatment has no effect) against the “alternative hypothesis” (i.e. the treatment works) with sufficient rigour to reject the null hypothesis. Most clinical trials accept a 5% statistical significance level to eliminate a false positive result (otherwise called a Type I error), which is usually quoted in the results section of scientific papers as being “p ≤ 0.05″. The p-value gives us the statistical significance with that cut-off figure of 0.05. There are problems with accepting this value, as it doesn’t tell the whole story of the validity of the results of a trial, as explained here by Professor David Colquhoun, but we’ll use this figure as being one that’s commonly used. We now need to have a sample size which is capable of accurately rejecting the null hypothesis when the null hypothesis really is wrong. This is often described as having sufficient power to not make a Type II error, i.e it won’t produce a false negative result. The greater the power of a study, the less likely it is to produce a false negative result. In clinical trials, a minimum acceptable power is at least 80% (See this paper on sample size calculation in clinical trials). So, for the purposes of the study in question, I’ll work on a power of 80% as being appropriate for this trial. Putting these figures into an online sample size calculator will allow generation of a sample size necessary for the trial to yield a reasonably meaningful result:-

For this trial to show an improvement from the baseline mortality of 32.3% to 25.8% with a power of 80% at a significance level of 5%, the study would need 1526 patients!!!!! This assumes equal allocation of patients to each treatment arm. By comparison the PROWESS study enrolled 1690 patients.

This trial enrolled a grand total of just 70 patients. The study is so grossly underpowered that it had no chance of producing any meaningful result whatsoever.

The paper does describe the process by which the homeopathic globules (the “remedies”) would be selected and chosen. Now – here we have a MASSIVE fundamental flaw. To quote “The homeopathic doctors (my italics) were free to decide which homeopathic medicine should be applied”. Seriously? The homeopaths were free to decide what remedy to give the patients? On what basis were the different remedies to be chosen?

In homeopathy, a claimed crucial part of the process is the consultation in which the homeopath elicits a symptom history from the patient, in order to choose a remedy. A fundamental tenet of homeopathy is that “like cures like” – usually referred to as the “Law of Similars“. It is the very concept that led Samuel Hahnemann to invent homeopathy. Patients with septic shock are frequently incapable of giving a meaningful history as they are too unwell. How then is it possible for the homeopath to determine with any degree of accuracy (as far as any homeopathic prescription could be described as accurate!) which remedy or remedies to prescribe for a particular patient?

What about the (theoretical) risk of cross-contamination from combinations of therapies? I say theoretical as, no matter what any homeopath might claim, there is no difference in any so-called homeopathic remedy which has been diluted beyond the 12C dilution and no practical difference in any diluted beyond 6C. For an excellent explanation of homeopathic dilutions, I recommend reading “Homeopathy: The Ultimate Fake” and “Discover Homeopathy – Science“. The “remedies” to be used in the studies were to be at the 200C “potency”. Ummm……ok. What this means is that 1 ml of the “mother tincture” – the starting material of the, err, remedy – is serially diluted in 100 ml of water 200 times! This gives a theoretical final concentration of 1 in 100 raised to the power of 200. To put it simply, this is a 1 with 400 (!) zeros after it. This is vastly greater than the estimated number of molecules in the universe (about one googol, which is a 1 followed by 100 zeroes). It’s fair to say that there’s no realistic prospect of finding a single atom or molecule of the “mother tincture” substance in the remedy. That’s before we even consider the problem of how the process of dripping the “remedy” on to sugar (typically lactose) pills can somehow transmit the “water memory” of that mother tincture to those pills.

At this point, there’s really no point in continuing to assess the paper against the CONSORT criteria as I’ve already shown that it has zero chance of reliably produce any sort of meaningful result. At best, it could be regarded as a pilot or feasibility study, but it has been presented as a clinical trial of an adjuvant therapy for sepsis, in much the same way as activated Protein C was studied as an adjuvant therapy in the PROWESS study. At this point I should remind the reader that subsequent trials of activated Protein C led to a re-evaluation of its efficacy, prompting the manufacturer, Eli Lilly, to withdraw it from the market. This shows that even when a study fulfils the criteria for being a “good” study and produces a positive result, it is still subjected to rigorous critical appraisal and its findings challenged by this process and by further data collection from other clinical trials and post-marketing surveillance.

Given the number of meta-analyses and reviews of homeopathy (Linde et al 1997 and 1999, Shang et al, The House of Commons Science and Technology Committee report, Cochrane Reviews, and Australia’s NHMRC) that have shown it to have no benefit for any disease or condition, it beggars belief that homeopathy is still marketed and practiced as a system of healthcare. Putting it bluntly, homeopathy is quackery. If a “Big Pharma” company were to behave in this manner (and it’s pretty certain that many of them have), there would, quite rightly, be an outcry as such behaviour is immoral, unethical and quite possibly illegal (though I would defer to legal experts on the question of legality). In recent years, a number of successful campaigns have been organised which are having the effect of drastically reducing the use of homeopathy on the NHS (yes, it is used in some parts of the UK – unbelievable!) and have demonstrated to the public that homeopathy is just simply useless. I refer the reader to the Nightingale Collaboration, Sense About Science, the Good Thinking Society and the 10:23 campaigns for further information on this.

To summarise this paper:-

A poorly structured study with no clue as to what they were aiming to show. This led to the study being grossly unpowered by a factor of more than 20. A variety of “remedies” used with no apparent control mechanism which had even the remotest possibility of detecting any effect from a particular remedy or combination of remedies.

It’s an utter car-crash!

To be fair to the authors, they conclude only that “Our data suggest that homeopathic treatment has a beneficial effect on the long-term survival of patients with severe sepsis, further research is required before making firm recommendations”. Sadly several homeopaths think that this paper is incontrovertible evidence that homeopathy is of benefit in septic shock. This begs the question – why, when this paper was published in 2005, has no-one published any further papers of clinical trials of homeopathy in sepsis?

To anyone with any reasonable knowledge of what homeopathy really is, it will not surprise them that there are no further publications on the subject. Homeopathy is an ineffective treatment of nothing more than sugar pills which have – at best – a placebo action. Homeopaths may twist and turn and use special pleading and downright lies and deceptions to promote their wares, but they cannot escape the facts of the matter. I’m disappointed that any Research Ethics Committee gave permission for a trial of useless sugar pill quackery in patients with a real, serious, life-threatening illness. I’d certainly be surprised if any Research Ethics Committee gave permission for any future trials of homeopathy in sepsis.

You say sepsis, I say blood poisoning

Adam Cairns, CEO of Cardiff and Vale UHB on the need to get the message about sepsis awareness into greater public view.

A Healthy Perspective


A few weeks back I was invited to the Senedd for world Sepsis day. The event was organised by Terence Canning who champions the cause of sepsis in Wales. Terence lost his brother to sepsis. He shares his story here.

At the event another story was told, about a young girl who had also died. Her parents were there to bear witness in the hope that their loss might be given at least some meaning by encouraging health care professionals to be more alert to the early signs of sepsis.

Terence is a much valued contributor to our Leading Improvements in Patient Safety Programme and his story never fails to remind all present just how devastating a missed opportunity can be.

It is estimated that sepsis kills 37,000 people each year in the UK. It is thought that more than a third of the deaths could potentially be prevented.

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Sepsis at the Senedd

For the past few years since the inception of World Sepsis Day in September 2012, the UK Sepsis Trust has organised reception events at Parliament. These events must be sponsored by an MP and financed by whatever organisation wants to promote their message. This and other work done by the CEO of the UK Sepsis Trust, Dr. Ron Daniels, has helped push the sepsis message into the minds of the politicians and has helped with the creation of the All-Party Parliamentary Group for Sepsis and has pushed NHS England into taking sepsis seriously. I won’t bore you here with details of what sepsis is or how common it – please visit the UK Sepsis Trust website for such details.

Health is a devolved matter, so while it’s all well and good promoting the sepsis message to MPs, in reality discussions with Westminster have little impact on what happens in Scotland, Northern Ireland and Wales. However, sepsis doesn’t miraculously stop at the Severn Bridges or Offa’s Dyke, so it’s as much a priority for NHS Wales and its political masters to take steps to reduce sepsis morbidity and mortality. I can’t tell you what happens in the NHS or governmental structures in the countries of our Celtic cousins, but I can give you a quick update on what goes on in Wales.

NHS Wales has a history of quality improvement, participating between 2004 and 2008 in the Safer Patient Initiative, organised by The Health Foundation. A huge part of this work was the Welsh Critical Care Improvement Programme. This resulted in significant changes in how aspects of patient care were delivered, helping (for example) to reduce the occurrence of ICU-acquired infection. This was followed by the launch of the 1000 Lives Campaign in April 2008, running until May 2010, to be succeeded by the 1000 Lives Plus programme, a national programme to build on what had already been achieved. One major workstream to reduce avoidable harm is the Rapid Response Acute Illness Learning Set (RRAILS). A key feature of this work was the introduction of standardised early warning scores across Wales, using the National Early Warning Score (NEWS), developed by the Royal College of Physicians in 2012. Through the RRAILS programme, Wales became the first country in the world to adopt NEWS as a national standard. The primary aim of the RRAILS programme is to identify patients who are deteriorating early so that therapy can be started as soon as possible, thereby reducing the chances of a poor outcome. Sepsis is a common cause of such deterioration, so it is natural that a great deal of the work of the RRAILS programme is to aid diagnosis and treatment of sepsis. Following on from this, Welsh Government put two targets for sepsis into Tier 1 of the NHS Delivery Framework for 2013/14 as development priorities.

When I first linked up with the UK Sepsis Trust in 2012, I wondered whether it would be a viable proposition to have a reception event, in a similar style to the London event, at the Senedd. The UK Sepsis Trust was supportive of the idea and I found an Assembly Member willing to be the sponsor. However, circumstances meant that I couldn’t progress this idea any further, although it was something that occasionally cropped up in conversations amongst colleagues with a major interest in sepsis care. The idea of a Senedd reception for the UK Sepsis Trust was resurrected by the Executive Director for Wales, Terence Canning. I first met Terence back in 2012 and it’s fair to say that he’s an inspiration and a tireless worker for the charity. Tapping into contacts already made in the past few years and using the expertise of PB Political Consulting, Terence was able to get the event organised for Thursday, 8th October 2015, with the Deputy Health Minister for Wales, Vaughan Gething, being the sponsor. If you’ve not visited the Senedd, you should!

The day was blessed with fine weather and the invited guests gathered – health professionals, health service managers, politicians, civil servants, families bereaved by sepsis and survivors of sepsis. Terence started proceedings, followed by Vaughan Gething and then by Chris Hancock (Programme Director and Manager of RRAILS). Chris spoke about how the work done via 1000 Lives Plus and RRAILS was beginning to show real benefit in reducing sepsis mortality across Wales. Everyone who has been involved in the RRAILS programme should be congratulated on what has been achieved so far.

It was then my turn to speak. This is what I said:-

“Helo, fy enw I ydy Paul Morgan

Hello, my name is Paul Morgan.

I’m a consultant in intensive care medicine and sepsis lead in the Cardiff and Vale University Local Health Board, and I’m Lead Volunteer in Wales for the UK Sepsis Trust.

Firstly, I’d like to thank Vaughn Gething for sponsoring this event and for the UK Sepsis Trust and PB Consulting for organising proceedings.

Sepsis is a major cause of death across the world. In the UK, it is estimated that there are over 100,000 cases of sepsis each year and is responsible for over 37,000 deaths. Yet, despite this, it remains relatively unknown in comparison to other major killers, such as heart disease, stroke and cancer. To give you some perspective of the size of the problem, sepsis kills as many people as die from breast, bowel and prostate cancers – combined. It is the leading direct cause of maternal mortality.

Here we are just a stone’s throw away from the magnificent Wales Millennium Centre and its beautiful Donald Gordon Theatre. Imagine the auditorium full. Every year in Wales, sepsis wipes out an entire audience. Of those who are fortunate to survive sepsis, about 20% are left with long-term physical and psychological problems and yet there’s very little, if any, support for sepsis survivors. Survivors also have an excess rate of hospital readmission in the next 12 months and may not be so fortunate next time.

Treating sepsis costs NHS Wales in excess of £100 million each year, much of it in Intensive Care. It accounts for at least one third of all critical care expenditure.

The saddest part of all this is that sepsis can be treated successfully and cheaply if caught early – and therein lies the major problem. In recent years, we have seen major campaigns leading to improved outcomes from heart attack and stroke, with a huge part of the success being the recognition that early treatment is key – this concept is known as “time is tissue”. We need to emphasise that sepsis is a whole-body attack and that time is tissue just as much in sepsis as it is in a heart attack. By promoting awareness amongst members of the public and among health professionals to think “could this illness be sepsis?” we can reduce both the morbidity and mortality from sepsis.

Today we are here to make you, our politicians and government officials, more aware of sepsis and to seek your help in reducing the morbidity and mortality. We cannot save everyone with sepsis – that would be unrealistic. But we estimate that we can save about one-third of those who currently die. The good news for you is that this can be done relatively cheaply – a really good example of prudent healthcare! Education programmes such as 1000 Lives are helping the early recognition of the acutely unwell patient and has had some success, particularly when combined with critical care outreach services. We also need better data to help us understand what really happens to sepsis patients so that we can deliver better care both during and after sepsis. The establishment of a national sepsis registry would be a massive step to achieving this. We’re making progress, but we cannot rest on our laurels. We need to do more to build on what has been achieved so far. We need your support to ensure that sepsis care gets the attention across NHS Wales at all levels – prevention, recognition, treatment and after-care. Sepsis care needs to be a core feature of the Together For Health NHS Delivery Plan.”

Formal proceeding were wrapped up by Ron Daniels, acknowledging the progress made in Wales and challenging NHS Wales to do even better. Game on!

I came away satisfied that there had been a real opportunity to engage with the Senedd about sepsis and to consider what we need to work on to make further improvements. I was therefore pleased to hear that Vaughan Gething was to make a statement in the Tuesday Plenary Session in the Senedd. I was able to watch this on line as the Senedd has a live feed and also stores an archive of broadcasts. His statement clearly told us that he had listened to what was said at the reception and had digested the information given to him. The short debate that followed was informed and conducted in a mature fashion that makes events in the House of Commons look silly and pathetic by comparison. To cap it all, we were mentioned as part of the discussions!

You can watch proceedings here – watch from about 3:09

I’m delighted to see that Welsh Government is continuing to give sepsis the attention it merits and it means we can work with them to deliver improvements in outcomes. I was recently made Sepsis Lead for the Cardiff and Vale University Local Health Board, demonstrating the commitment of my employers to further improve sepsis care. By working as a team across the acute specialities, I hope – sorry, expect – that we can make further progress.

A homeopath doesn’t like being called out for promoting misinformation

Long-time “friend” (they’re certainly well-acquainted with him) of the Advertising Standards Authority (ASA), Steve Scrutton, a Homeopath from Corby, is a regular poster on Twitter and his own blog (ironically titled “Safe Medicine”) about his chosen means of earning a living and also about various other subjects such as anti-vaccination and other forms of quackery. It’s fair to say that he exhibits features that fall under the term of crank magnetism. His brushes with the ASA were based around him making claims of benefits for products he was selling via a website he ran. I don’t know the details, but he was ordered to remove the claims. Having failed to do so, he was then listed by the ASA as a “non-compliant advertiser”. I don’t know whether he did comply by changing that website or simply closed it down, but it seems he’s no longer on that list. Just as well, as repeated non-compliance can lead to prosecution by Trading Standards!

Since I joined Twitter a few years ago now, he’s been someone whose tweets have found their way into my timeline and/or mentions columns. I don’t follow him, nor do I stalk him in the way that some obsessive homeopathy fans stalk people who counteract their stupidity with actual science, rational thought and critical appraisal. Yes, I particularly refer to a woman called Sandra Courtney aka @BrownBagPantry on Twitter – her modus operandi is to block people but then keep a Twitter feed open looking at the tweets of people she’s blocked before posting screen captures of their tweets and/or creating childish images.
Anyway, back to Steve.

Every so often, I have the misfortune to see a tweet from Mr. Scrutton that promotes homeopathy as being a treatment of benefit in a wide variety of health conditions. Some of these conditions are very real, others – it may be said – have less basis in reality. Not that such things necessarily worry homeopaths.
To be absolutely clear about what homeopathy is and what it isn’t, let’s take a quick look. In essence, a German physician called Samuel Hahnemann in 1796 was disillusioned with the conventional medicine of the day. To be fair to him, most of what was available was pretty awful – a variety of toxic potions and blood-letting was the mainstay. Rather than going into detail, I’ll post this link about the history of homeopathy. A detailed description of homeopathy can be found here.  There have been many studies of the effectiveness of homeopathy, many claiming positive results. There have also been many showing negative results too. The selective quotation of positive results is termed cherry-picking. Homeopaths and their fans are every bit as bad about this as any other advertiser and, sadly, many scientists. To overcome the issues of such selection bias, it’s necessary to first understand how to critically appraise a scientific publication. In medicine, this is a core skill in the development of the practice of evidence-based medicine (EBM, for short). A useful website that explains how EBM works and how to do it is this one –
As you might gather, a major problem for homeopathy is the complete lack of prior plausibility – there’s no rational reason, given our understanding of basic chemistry, physics and biology – why homeopathy should have any effect beyond placebo. Homeopaths seems to struggle with the concept that their various sugar pills and nostrums are just placebos and that claims of benefit, usually based on anecdotes or small studies can be explained either by the placebo effect or the phenomenon of regression towards the mean. When people rely on homeopathy to treat real diseases, the consequences can be disastrous. See here for a list of examples and here for the particularly tragic and awful story of Penelope Dingle.

I’m pretty sure that at some point in the past, I’d responded to some of Scrutton’s tweets by asking for credible evidence and/or pointing out the flaws in claims he’d made. I think I’d posted some comments in response to posts on his blog – Steve didn’t take kindly to this, not allowing my comments to pass (his) moderation. Ah well – it’s his blog! Recently, a new flurry of his tweets came into my view, repeating a number of repeatedly disproved and debunked claims. This is commonly referred to as a PRATT – a Point Refuted A Thousand Times. A standard practice of repeating a claim multiple times in the mistaken belief that it will somehow make their claim true or maybe they’re simply hoping that a more gullible, less skeptical audience will see their claims and take them at face value. It seems that Steve didn’t take too kindly to having his claims questioned and so he decided to write a blog post all about me. Steve – I’m flattered! Yes, I’m angry – angry that homeopaths keep making claims that aren’t supported by robust scientific evidence and that people are duped into buying their wares when the evidence is clear. Homeopathy has been conclusively shown to be of no benefit beyond placebo when subjected to appropriate critical appraisal. When trying to summate evidence from a variety of clinical trials, the best method to make an assessment of the evidence is to conduct a meta-analysis. This can be quite challenging and time-consuming, as it’s necessary to assess the quality of each trial. Nevertheless, there have been meta-analyses of homeopathy, most notably in The Lancet by Shang et al and, more recently, by the Australian Government’s National Health and Medical Research Council just a few months ago. These meta-analyses are bad news for homeopaths as – unsurprisingly – they show that homeopathy is just placebo. But why let the hard facts get in the way of your business model? The amount of bleating and pleading for special treatment by the homeopaths is enormous! Not to mention trying to create conspiracy theories about “Big Pharma” buying off the authors of the reports or that the meta-analyses are somehow intrinsically biased or deliberately misleading. Let’s see how they try to deny reality –

Very sad and pathetic.

So, let’s have a look at the specific whinges, sorry “allegations” made by Scrutton about me.

Firstly, he complains that my response to him posting a link to his blog post about tetanus as being “per abuse” – I think he means “pure abuse” but I can forgive the odd typographical or spelling error. Tetanus is a really horrible, nasty disease with a high mortality rate. Read more about it here.

I said that his claim of benefit for homeopathic remedies in treating tetanus was ““Stupid, idiotic, downright dangerous. You should be ashamed for promoting such dangerous, bad advice”. Which it was. Let’s see what the scientific evidence for homeopathy in the treatment of tetanus might be. First, a PubMed search for “homeopathy tetanus” (“homoeopathy tetanus” gives identical results) gives the following exhaustive list of published papers of scientific evidence:-

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So – just two papers, one of which refers to athletic injuries and the other is about attitudes of homeopaths towards vaccination! Oh dear – this isn’t looking good for Steve. Maybe my search was too specific? I tried several similar searches – same results. Maybe Google will yield more? Of course it does! Shame that on the first page almost all results are from homeopathy websites – one is from the truly crazy (made famous by being the basis of Scopie’s Law). The only other article on that first page is this one. OOPS! Maybe Steve meant homeopathic vaccination – truly an oxymoron – for tetanus. Oh dear again! PubMed gives just that first reference from that first search. For an excellent summary of so-called “homeopathic vaccines” you could do worse than read this. Just deluded nonsense.

Oh Steve! You made claims without any supporting scientific evidence. My comment was therefore totally justified.

On to Scrutton’s next moan, about how I called him out for promoting homeopathy “remedies” for psoriasis, an unpleasant skin disease than can be painful and disfiguring. I said, apparently (probably!) that his claims of benefit for the remedies “…..are all equally useless identical sugar pill placebos”. A PubMed search yields a pretty poor – but still better than for tetanus – 16 results. None are randomised controlled trials. Not a good start. Some of the list are about a variety of  chronic skin conditions, including psoriasis, but with very small numbers – certainly nowhere near enough to ascribe any benefit to any homeopathic “remedy”. The only paper with a half-decent is “Homeopathic treatment of patients with psoriasis–a prospective observational study with 2 years follow-up”. The abstract is available via PubMed. Just 82 patients in an observational trial treated by 45 different “physicians”. Does this constitute evidence of benefit? Err, no. It’s a small observational study where much of the claimed improvement could easily be due to regression to the mean. A letter published in the October edition was not exactly complimentary – sadly, I can’t link to it as it’s a pay-to-view journal, but if you have access you can find it from    A Google search yields just links to various homeopathy-promoting websites.

Oh dear again, Steve! Again, there is no published scientific evidence to support the claims you made. My comment was therefore totally justified.

Next up, Steve objects to me commenting that his claims of benefit for using homeopathy to treat mustard gas exposure are “Utterly deluded nonsense”. Scrutton would appear to be referring to experiments conducted by the British Homeopathic Society for the Ministry of Home Security in 1941-42. Mustard gas was – and still is – an agent used as a chemical weapon in World War 1. It is highly toxic. In the past few weeks, it has been reported in the media that it is being used in the Syrian conflict. Technically, its use for war was banned under the terms of the 1925 Geneva Protocol. After WW1, chemists were able to investigate the biological effects on mustard gas and by manipulating its structure, they synthesised the very first cancer chemotherapy agent. It’s transformation from an agent designed to kill and maim to one of therapy is documented here by Cancer Research UK. That’s not to say that these drugs aren’t still toxic, but great progress has been made in cancer care ever since.

Fearing a repeat of the horrible effects of mustard gas chemical attack, British Government scientists were keen to develop antidotes as World War 2 began. One group they asked to see if they could help was the British Homeopathic Society. They initially said that there was no evidence of benefit from “homeopathic mustard gas potencies” but that a few homeopaths were calling for such preparations to be made for use in the event of mustard gas attack. They proposed that trials were undertaken. Trials were undertaken in Glasgow, but were inconclusive. A second set of trials in London was initially reported as showing some benefit for the homeopathic preparation. However, the results were rejected by the Ministry. This appears to be despite a reasonable study design.The results of both sets of trials were reanalysed in 1982, but the results were not published in any meaningful format. The authors of the reanalysis concluded that the Glasgow results were more likely to have shown benefit for the homeopathic preparation, but that the London trials were not analysed using appropriate statistical tests. The trials are documented here by the James Lind Library and re-published in the Journal of the Royal Society of Medicine. What we have here, then, is a mixed bag. A Google search only produces a list of websites, blogs and comments by homeopaths linking to the same set of studies. Is there any further evidence one way or the other? A PubMed search yields just two results. Unsurprisingly, they are the same as before – theJournal of the Royal Society of Medicine article and an article in “Homeopathy” about the same experiments. Despite this total lack of any further evidence, homeopaths commonly recommend homeopathic mustard gas as a remedy. I wonder where they obtain the mother tincture from?

So, the evidence of benefit for homeopathic mustard gas? Basically, none. All we have is a couple of trials from the early 1940s which were inconclusive and nothing since. Oh dear, Steve! In calling your claims of benefit for homeopathy in treating mustard gas exposure “utterly deluded nonsense”, it would seem from the evidence that I’m right.

Not going too well, is it Steve?

Next up, and finally, Scrutton goes off the deep end about my support for vaccination and my view that getting vaccinated is a civic duty to bolster herd (community) immunity. It does seem that most homeopaths are part of the anti-vaccine crowd of fools and that Steve is deep into the delusion that vaccines are dangerous and don’t work. It is true, of course, that vaccines are not 100% effective or reliable, but generally they improve the odds of not catching a fatal disease by several orders of magnitude. This also emphasises the need for herd immunity so that those who cannot safely be vaccinated or those in whom a vaccine may not be effective are still protected by the disease being kept at extremely low prevalences or even totally eradicated (smallpox). Last year, the influenza vaccine was, quite frankly, not great, being only about 34% effective. Influenza viruses are tricky, devious little so and so’s. Work is ongoing to developing a universal influenza vaccine, but it’s not yet approaching clinical use. Last year’s vaccine was rendered less effective than desired due to viral genetic drift. Vaccines can have adverse reactions, but these are mostly mild and transient. Severe, long-lasting reactions are extremely rare. Most are due to anaphylaxis to vaccine components. In the USA, a database of adverse reaction reports is collated in the Vaccine Adverse Event Reporting System (VAERS). The existence of this database is frequently pounced upon by anti-vaxxers as evidence of harm from vaccines. However, this is simply not the case. While it has helped identify a number of serious adverse reactions to vaccines, the overwhelming majority of reports are either of the mild variety described earlier or are not related causally to the administration of a particular vaccine.

The biggest scandal in the field of vaccination was, of course, the work of no-longer-a-doctor Andrew Wakefield who claimed that his research showed a link between the administration of the MMR vaccine and the development of autism. This work has been subsequently discredited and the Lancet paper retracted. Subsequently it was shown by an investigation conducted by Brian Deer that Wakefield’s work was fraudulent. As a result of this, Wakefield was struck off the General Medical Council register in 2010. Despite saying he would appeal against this ruling, he never did. He also made several unsuccessful attempts to sue Deer and others.

Scrutton claims that the diseases prevented by vaccines are not preventable by vaccines. Oh really? The evidence conclusively shows that Scrutton is wrong. Next he claims that the diseases vaccinated against are not dangerous and are not life-threatening. Oh really, again? Where do I start with this depth of ignorance? Vaccination has eradicated smallpox. Smallpox used to kill and maim. So, not that dangerous at all – if you ignore the 30% death rate. Measles can kill and maim. This year saw the first recorded measles death in the USA since 2000.  A particularly nasty complication is subacute sclerosing panencephalitis (SSPE). I could go on and on, but even just with these two vaccine-preventable diseases, it can be conclusively shown that Scrutton is utterly clueless and factually wrong. Finally Scrutton claims that there’s no such thing as herd immunity because vaccinated people have gone on to contract the disease which they were vaccinated against. Steve’s ignorance is manifold. As already stated, vaccines are not 100% effective and many are not long-lasting in benefit. An excellent summary is provided here from New Zealand. Scrutton states that herd immunity is only good for the profits of pharmaceutical companies so they can sell more vaccines. Laughable! Let’s look at what “herd immunity” is. Rather than me try to explain it, let’s look at what real scientists (i.e. not a homeopath) say what herd immunity is and how it works. From the Oxford Vaccine Group Vaccine Knowledge Project. From the World Health Organisation.  From Dr. Rachel Dunlop, Post-doctoral fellow in cell biology at the University of Technology, Sydney, Australia (linking to this other article here) – notice how she debunks other myths about vaccines typically spread by anti-vaxxers. Here’s another description by the National Institute of Allergy and Infectious Diseases, part of the USA’s National Institutes of Health.


Once again, it seems that the evidence is conclusively showing Scrutton’s assertions to be wrong. Of course, there are people who should not be vaccinated at a particular time of their life or indeed ever. It is these people who benefit most from herd immunity! So, when I said that vaccination gives freedom against preventable, dangerous, life-threatening diseases, the evidence shows that this statement is backed up by overwhelming scientific evidence. As for herd immunity being a civic duty, then yes, I believe that it is a civic duty to be vaccinated if possible, in the same way that you have a civic duty not to drive when under the influence of alcohol or other drugs that affect your ability to drive competently and safely.

Scrutton ends this rant by claiming that I am abusing people who choose not to use “conventional” (as in real, proven, effective) medicines, opting instead for various forms of quackery. Wrong again, Steve. I point out factual inaccuracies in the claims made by people who promote those various forms of quackery. I provide links to the scientific evidence. I ask people making such claims to provide the evidence that supports their claims. When they provide what they think is evidence of benefit to support their claims, I debunk it.

I really don’t care if you think that this is abuse. Asking you to back up the claims you make is not abuse. The Advertising Standards Authority and the Committees of Advertising Practice work on the principles that advertisements must be legal, decent, honest and truthful – but I’m sure you know all about this, don’t you? And there’s more here. In fact, the CAP use you as an example of how not to advertise.

Ranting against those calling you out for promoting misinformation does appear to be a nasty habit of yours. Particularly, it seems, you dislike the ASA. The ASA dislikes people making claims that can’t be backed by evidence – like you, for example.

DNACPR, death and dying in the Intensive Care Unit

DNACPR, death and dying

Election reflections

So we’ve had the results of the elections for the European Parliament. This election is a curious beast in UK terms as it’s done by a form of proportional representation (PR), yet appears superficially similar to the traditional “first past the post” (FPTP) system we’re familiar with. It’s certainly different from the PR system we use in the elections for the Welsh Assembly. In the European election you get to vote for a political party who may field a number of candidates up to the available number of seats for a region, rather than for a particular candidate (who usually represents a political party) in a parliamentary constituency. Of course, the regions for the European elections are rather larger than the UK parliamentary constituencies such that in Wales there are 4 MEPs whereas we have 40 MPs.

In the past few European elections the United Kingdom Independence Party (UKIP) has managed to gain several MEPs, partly because the PR vote counting system has enabled them to gain seats from the second/third/fourth/etc. place vote allocations. At the previous election, they had 13 MEPs despite never yet gaining a seat in the UK parliament. Hmm.

To be clear, I regard UKIP as the most abhorrent political party in the UK. True, there are parties (tiny though they may be) with more extremist views, but at least they tend to be less – shall we say – coy about their views. It seems sometimes, however, that various UKIP candidates, councillors and (now) MEPs seem occasionally to let the veils slip, revealing their true colours. In the press and social media comparisons to 1930s Germany abound.

I was, until recently a Liberal Democrat supporter. When it was announced after the 2010 General Election that they were to form a coalition government with the Conservative Party I was anxious but cautiously optimistic that they would help re-establish the economy without allowing it to overheat in the way the Thatcher government did, which culminated in Black Wednesday as a strange desire to tie the value of Sterling to the then powerful German Mark resulted in spiralling interest rates and economic disaster. I also hoped that some of their sensible policies on (for example) university tuition fees and taxation would get into law while at the same time they would prevent the more extreme policies of the Tory right wing from being enacted. Sadly, I was largely wrong. While the threshold for liability for the basic rate of taxation may have been implemented, I am struggling to name any other successful LibDem policy. Instead, we saw a referendum for a change in the voting system from FPTP to a PR system called “Alternative Vote” (AV) that, it seems hardly anywhere in the world uses. The British voting public may or may not have understood how AV works but what was clear is that it simply didn’t care as only 42% of the electorate voted and AV was blown away without a trace. The price the LibDems appear to have paid for this has been Tory appeasement as we have watched the Health and Social Care Act passed with barely a murmur. We have seen the “bedroom tax” imposed. We have seen Universal Credit being introduced and the consequences are disastrous as more people fail to pay rents and Council Tax bills – a total shambles. We have seen Legal Aid not restructured sensibly but decimated. It’s now increasingly difficult to take action at an Employment Tribunal for wrongful dismissal. We’ve seen ministerial interference with the education system in the shape of the “free school” – which is a meal ticket for cranks and extremists to indoctrinate children while simultaneously failing to provide them with an education. And then there’s the “Help To Buy” system which is already leading to overheating of the housing market. The poor, the sick and the disabled have been demonised – we’ve seen suicides as a direct result of these policies and incompetent assessments stripping desperate and vulnerable people of money. And then there’s that great government success – the rise of the food bank. What did the LibDems do to protect the British public from the rank stupidity and the sheer crassness of these policies? Policies that threaten the very existence of the NHS – the invention that the United Kingdom is rightly proud of and – despite it’s problems and oft-justified criticisms – remains one of the best healthcare systems in the world 

Click to access 1717_thomson_intl_profiles_hlt_care_sys_2013_v2.pdf

So, when you see me defending the NHS, I’m not doing it out of blind faith! Yes, the NHS isn’t perfect but privatisation is not the solution. Tory politicians seem so enamoured with US-style healthcare yet it’s ranked far lower than the NHS in world terms, costing about twice as much per person in terms of GDP and with a lower life expectancy. No.

The LibDems could have stopped the Health and Social Care Act, but failed to do so. Likewise the Bedroom Tax, etc. They have paid the price at the recent Council elections, losing 310 seats in England. The Tories lost 230 seats while UKIP gained 161 and Labour gained 338 seats. However, anyone reading the papers or watching the BBC news, for example, would think that Labour had been slaughtered while UKIP were now in charge in many areas. The reality is that UKIP control a grand total of ZERO councils! The same number as before the election.

UKIP have benefitted from a disproportionate amount of media coverage, but the seats gained have been very patchy. They did poorly in London, for example. The prospect of UKIP having any MPs, let alone being in a position to hold the balance of power if there was no overall winner is a horrific one, given their stated policies. The media coverage of UKIP in the last year has not just been disproportionate in terms of volume but also in content. You won’t find much said about their policies of scrapping the NHS, abolishing maternity pay and a single flat rate of income tax (thereby affecting the poorest the most) in the mainstream media.

But the saddest fact about the council elections of May 22nd 2014 is the voter turnout – just 35% overall. In other words, for various reasons, 65% of the English electorate did not vote.

What about the European elections? Here we saw the combination of several factors contributing to UKIP almost doubling its number of MEPs up to 24 and being the top party of all, beating both the Tories and Labour while the LibDems were almost eliminated from Europe, retaining just a single MEP from a previous 10. They have truly paid the price for their capitulation to the Tories and face a similar situation in the 2015 General Election according to the opinion polls. Is there ANY hope for redemption for the LibDems? To me, there is only one hope by which the LibDems can regain any credibility – even though they would still lose a whole host of seats. They should pull the plug on the coalition government NOW! Only then can they start out on the road to political redemption.

The turnout for the European election was a paltry 34.19%. This is shameful. The turnout in the 2010 general election was 65.1% – still bad, but nearly double the council and European elections. Just what is it with the British public and failing to vote? There are many quotations regarding democracy and voting that seem apposite. For example, if you don’t vote you get the government you deserve and if you don’t vote you end up being governed by your inferiors. Certainly seems true regarding UK politics!

Why do people not vote? Much has been made of statements about not voting made by Russell Brand. Blaming a daft actor for your not voting is pretty pathetic and overly simplistic as an explanation for a poor turnout – his statement has had basically zero effect on the turnout for council and European elections.

For many, they feel that their vote doesn’t count or that there’s no political party that truly represents their views. Often they may like certain policies of a party but vehemently disagree with others. To those who feel disenfranchised in this way I say – I can understand your reluctance to vote but it’s surely better to vote to ensure that the worst possible candidate doesn’t get in? Surely it would be better to vote for the least bad option in the constituency to prevent you ending up with your MP being, for example, a member of the BNP? Every vote counts and those with extreme views will always vote.

Others may complain that it’s inconvenient to vote. Sorry, this doesn’t wash. Anyone who is entitled to vote in a UK election can get a postal vote. It’s a simple, straightforward process. The voting paper arrives well before the election date and the instructions on how to vote are pretty straightforward. I’ve voted by post for some years now, even though my polling station isn’t exactly far away.

So what other excuses are there for not voting? Some people say they would like to have a voting option on the voting slip of “none of the above”, suggesting that somehow any votes cast for this option should be deducted from the votes for the candidates. I have no idea as to how this could be put into practice. Of course, it’s appealing to vote against something you don’t like, but it’s not really how politics works. If there was just a single issue to consider then we’d have a referendum rather than a general election. Rarely do we see single cause political parties or independent candidates getting elected to Parliament for this very reason.

Overall, I think there’s little real reason not to vote. What this election has shown is that  – not just in the UK – voter apathy has been a major factor in determining the outcome in many European countries while parties with extreme views make major gains, such as in France. What this shows is that the supporters of extremist parties feel sufficiently motivated to vote while the moderates and mainstream voters often just can’t be bothered. The only slight hint of good news from the UK elections for the European Parliament is that the BNP no longer have any MEPs. The problem is that the rise of UKIP means that much of the UK will be represented in Europe by a political party who wish to do more damage to Europe –  and UK interests therein – than even the Conservatives wish to do. Yes, there are Tories who wish us out of the EC but – much like the NHS – the solution isn’t to quit Europe but to reform it without destroying it.

The mainstream media have much to answer for in boosting the UKIP vote. Of course the right wing rags have provided ample ammunition to supply the fear that UKIP played on, largely ignoring any evidence that shows them to be wrong. But the BBC also has a lot to answer for, with many commentators on social media suggesting that BBC One be renamed “BBC Farage” as it seems hardly an hour goes by without him popping up on our screens somewhere and Alex Salmond complaining that the rise in the UKIP vote in Scotland is due to the BBC beaming in coverage with Scotland having no control over such matters. The mainstream media seem to be focussing their attentions on the gains made by UKIP while musing as to how this could have happened (hint – look in the mirror), while ignoring the fact that Labour also made great gains, being the top party in the council elections and coming second in the European elections and having their best performance in this election for 15 years. Labour does appear to have an image problem and what portrayal there is in the media is usually negative. They did many things badly when in power, but the current government are far worse. Labour needs to get its act together before next year to not just prevent the Tories from being in power but to prevent a lurch to the right as we’ve just seen in the European election. Many are saying that people will vote differently in a General Election and that it will be difficult for UKIP to gain any MPs. I hope this is true, as for me even a single UKIP MP is one too many.

It is your democratic right to not vote if you so wish, but please consider the consequences of your inaction as you may be condemning us to repeat the mistakes of history.



Smoking in hospitals – is a complete ban essential or even desirable?

All views and opinions expressed in this blog post are my own and are in no way reflect those of my employers or any professional bodies I am associated with. I also make no claim to this article being heavily researched and evidence-based. Rather I would describe it as my considered views on a subject which has been divisive within the health professions.

Firstly, let me say that I hate smoking. I hate all forms of smoking and all substances that are smoked (not smoked fish, ham, etc!). Cigarettes, cigars, pipes, tobacco, cannabis, crack cocaine. Tobacco smoking killed my father through him developing ischaemic heart disease and affected my mother with a stroke. They are all drugs with the potential to cause great harm. Some are legal, some are not –  a distinction that, perhaps, bears further scrutiny, but this is not the time or place for a discussion on drugs policy. The health risks of smoking tobacco are well-known and include lung cancer, oral cancer, laryngeal cancer, ischaemic heart disease and peripheral vascular disease.

For many years, the debate on how to deal with patients who smoke has continued. I can recall working as a volunteer in my local district general hospital when the day room at the end of the ward was filled with smoke. It was absolutely horrible and unbelievably unpleasant for non-smokers to go in to. In those days, however, there was no other way for patients to watch television – it was the day room or nothing. Having to go outside to smoke was never contemplated by patients, visitors or staff. Coffee rooms, canteens, offices were all places to smoke. The only thing stopping patients and others smoking in their beds was the risk of fire due to there being piped oxygen – and even that didn’t always stop everyone!
I grew up with the anti-smoking message being pushed hard through public information films in schools, in the cinemas and on the TV. I recall from my childhood the first warnings about smoking damaging health appearing on cigarette packets. It was great to see how this powerful public health message reduced the percentage of the population smoking substantially. More than half the adult population smoked at the start of the 1970s

The figure now is about 22% of adult males and 19% of adult females.

This is a massive advance, but bear in mind that the UK population has grown from approximately 56 million in 1971 to 63 million according to the 2011 Census

The massive hike in taxation of tobacco has also been a major help here.

As society has changed and become less tolerant of smoking, we have moved smoking out of the working environment and hospital wards. Smoking is now banned in enclosed public spaces, an area of public health policy where Wales had to show England how to do it right 😉 We can now go into a pub or restaurant without having to endure the blue choking smog of cigarette smoke. You can now go for a night out and not come home with your clothes stinking of stale cigarette smoke. Brilliant!

Within health care, the debate about what to do with smokers has raged, with extreme views being expressed on both sides from the likes of FOREST whingeing about denial of human rights of smokers (forgetting that non-smokers human rights are being adversely affected) to the views of those who would deny treatment to people suffering from smoking-related diseases (which would make them the modern equivalent of the Bibilcal leper). Fortunately, sense has largely prevailed here – after all, why discriminate against one section of society on the basis of their own particular form of addiction? Do we discriminate against alcoholics or those addicted to heroin? No.

So we find ourselves in a situation where smoking is officially banned within hospital buildings in accordance with smoking legislation – this is a good thing. However, we now have the problem of the smokers gathering around hospital entrances, whether that be a main entrance, A&E, maternity or even the paediatric unit. Staff and visitors frequently find themselves having to “run the gauntlet” to enter and exit the hospital passing through a smoke haze reminiscent of “Stars In Their Eyes”  – without the nice treat on the other side…..

Hospitals, Trusts and Health Boards have attempted to impose more and more stringent restrictions on where smokers can smoke. Staff are now potentially at risk of disciplinary action if they smoke on work premises. While this may be the theory, it is well-known that this rule is flouted on a daily basis on the vast majority of hospital sites. Many hospitals try to deal with the issue of entrances being smoking sites by providing smoking shelters away from the entrances.

I support all moves to make the working environment, inside and out, smoke-free. NHS staff should be setting an example by not smoking at work or if wearing anything that identifies them as a member of NHS staff. However, hospitals are places where there are enormous psychological stresses in additional to the physical stresses. Everyone working at the “sharp end” of health care provision is at risk of such stress. The patients, their families and friends are, however, the ones who are more directly subjected to these stresses. Part of our job as health care providers is to help them deal with these stresses, supporting them and caring for them. When it comes to smoking – or indeed any other form of drug addiction – we should do our utmost to discourage smoking. But there are times when such discouragement is, perhaps, best put to one side in light of the bigger picture. Attempts to stop smoking are, in my opinion, best made when patients are not acutely unwell or recovering from illness but when they are well or their chronic health conditions are stable.

I work in Critical Care, possibly second only to A&E in terms of acutely stressful situations. While it’s incredibly rare for our patients to go off for a cigarette, we all too frequently find ourselves breaking bad news to the families of seriously ill patients. It would come as no surprise to find that if there are smokers in those families, then one reaction to the stressful situation they find themselves in would be to seek solace in the form of tobacco. Please note – I will say this again – I do not condone smoking. However, there is a time and a place to get the anti-smoking message across – such a time as described is not that time! So, if smoking is not permitted on hospital premises, what is the distraught relative to do? Where are they to go? Is it really justifiable to force them completely off the premises just to satisfy a desire to ban the consumption of a drug which can be bought and consumed perfectly legally?

The issue is therefore one where the need to push the anti-smoking message and prevent smoking in places where it impinges on the lives of the vast majority of us who are non-smokers has to be balanced against how we as a society treat drug addicts. We need to be clear on this – tobacco consumption is every bit as addictive as the likes of cocaine and heroin, but it’s history means that it has held an unmerited place of privilege in society for hundreds of years. In recent years we have seen an upsurge in publicity (don’t know about consumption) of so-called “legal highs”, with the evidence of harm from such agents coming to light. Imagine, therefore, what would happen if tobacco were to be such a new agent now? Highly addictive and with strong evidence of long-term harm, it would soon be banned under the current drugs legislation. But it’s not banned and neither is alcohol. (Declaration of interest here – I drink liquids that contain alcohol fairly regularly). These legal drugs are regulated through licensing and taxation and the places they can be consumed is also controlled to some extent. When people addicted to these drugs come to require inpatient health care, they are placed in an environment where their ability to continue consuming their drug(s) of addiction is severely curtailed. If they are unable to access and consume tobacco and/or alcohol they frequently experience withdrawal symptoms. This is no different to when people who consume other drugs withdraw acutely from their particular substance of addiction. The symptoms and effects of withdrawal from tobacco and alcohol can be very severe, often putting patients and staff at risk. So why are these patients being forced to go “cold turkey” in this way? It’s not the way that other drugs addicts (e.g. heroin) are treated – granted, we don’t feed their addiction but we at least try to provide a strategy to manage their withdrawal. For the alcohol consumers, benzodiazepines are frequently used to manage withdrawal with variable success. So – what about the tobacco smoker? The use of nicotine patches can be effective in helping smokers quit

However, has anyone studied acute withdrawal in those patients? Yes -sort of. A 2008 update published by the US Department of Health and Human Services entitled “Treating Tobacco Use and Dependence” covers the topic in remarkable brevity (page 149)

It may be that we can do more to help smokers quit while they are inpatients, but is this happening? In Cardiff, there is a Hospital Smoking Cessation Service and across Wales there is “Stop Smoking Wales”. Many Trusts elsewhere in the UK also run similar services. However, the effectiveness of such services is variable according to a review published in 2009 in the “Journal of Public Health”.

So, it seems unlikely that we can get every inpatient smoker to quit during their stay and we might expect to see patients suffering withdrawal symptoms. We are highly likely to see relatives who are smokers feeling the need to smoke when having to deal with highly stressful situations. Should we be demonising these people? How do we balance the desirability of helping smokers to quit with the reality of not causing great distress to patients and relatives? Many hospitals have provided smoking shelters in the same way that many pubs have smoking shelters or outside areas where smokers can indulge their addiction without inflicting their smoke on others. We need to have the smokers moved away from the hospital entrances! Is it sensible to even try to have a complete ban on smoking on the hospital site? Is there any hospital site that imposes such a ban actually being 100% smoke free? I very much doubt it and I also say that such a blanket ban is undesirable. It is interesting to see how there are parts of the UK where people addicted to injectable drugs (i.e. heroin) are managed. In some, heavy-handed policing is used to drive addicts off street corners. In others, needle exchange programmes exist to reduce health risks to all. Such programmes are highly effective when combined with addiction counselling

Is there a risk to banning smoking on NHS hospital sites? Yes. While I may disagree with the flippancy at the start of this newspaper report, the last few paragraphs are rather better. Another article was published in the Canadian Medical Association Journal also suggested that harm may result from smoking bans.

Next, let us consider the practicalities of enforcing a smoking ban on a hospital site. Whose job is it to enforce the ban? Who will patrol the hospital site 24 hours a day to ensure compliance? I would say that the majority of hospital sites simply do not have enough security staff to even have a remote chance of effecting such a ban. The security staff usually have other duties to carry out, such as protecting the safety of staff from assault (major kudos to Cardiff & Vale UHB this week – ).

To my mind, a complete smoking ban is neither practical nor desirable. Of course, we must continue to educate and support those who wish to quit smoking. We must continue to emphasise the undesirability and unacceptability of smoking. But there is a time and a place to be rigid in stopping people smoking – it may well be that the time for such rigidity is not during an inpatient stay or when a loved one is critically ill.



Welsh Intensive Care Society 2013 Summer Meeting

Welsh Intensive Care Society 2013 Summer Meeting