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ongoing web column  by Brunella Longo

This column deals with some aspects of change management processes experienced almost in any industry impacted by the digital revolution: how to select, create, gather, manage, interpret, share data and information either because of internal and usually incremental scope - such learning, educational and re-engineering processes - or because of external forces, like mergers and acquisitions, restructuring goals, new regulations or disruptive technologies.

The title - I Changed My Mind Reviewing Everything - is a tribute to authors and scientists from different disciplinary fields that have illuminated my understanding of intentional change and decision making processes during the last thirty years, explaining how we think - or how we think about the way we think. The logo is a bit of a divertissement, from the latin divertere that means turn in separate ways.

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It is a system, not an organ - Part 1

Health literacy and change management in the treatment of autoimmune diseases

How to cite this article?
Longo, Brunella (2019). It is a system, not an organ - Part 1. Health literacy and change management in the treatment of autoimmune diseases. icm2re [I Changed my Mind Reviewing Everything ISSN 2059-688X (Print)], 8.6 (June).

How to cite this article?
Longo, Brunella (2019).It is a system, not an organ - Part 1. Health literacy and change management in the treatment of autoimmune diseases.. icm2re [I Changed my Mind Reviewing Everything ISSN 2059-688X (Print)], 8.6 (June).

I want love or death, I want to die completely,
I want to be you, your blood, the roaring lava
bathing your beautiful extremities
while sensing in its confinement life's glorious limits.
Vicente Aleixandre
Unidad en ella, from La Destrucción O El Amor.
Translated by Robert G. Mowry

London, 27 June 2019 - In this article I return on the subject of health literacy I wrote about in other icm2re issues (Longo 2015, 2017, 2018) to consider change management in the treatment of autoimmune diseases. These are diseases determined by unpredictable, confused and abnormal behaviours on the side of the immune system, ascertainable mainly because in doing so it produces - most of the times - autoantibodies detectable in the blood stream.

The first part of this article presents an introduction and some reflections on four fundamental reasons why institutions, specialists and policy makers find so difficult to make successful changes in the treatment of autoimmune diseases, in spite of a considerable amount of evidence poured into the public domain during the last twenty years. These reasons I have identified are:

  1. the delay in adopting new revolutionary techniques and methods of screening and diagnosis;
  2. the lack of awareness, acceptance and capacity in managing knowledge and learning processes due to the accelerated pace of discovery of new diseases and new drugs many doctors and the whole of the healthcare system do not understand and are not even aware of;
  3. the absence of adequate regulations for clinical trials and for studies that tend to increase societal risks of creation of new diseases without curing the existing ones - and the lack of policies about long term research investments these risks stem from;
  4. the global challenge of potential breakthrough advances in immunonutrition and nutrigenomics that could revolutionise the entire food industry and medical sciences and yet remain so far mostly suffocated - once again - by short term commercial goals and absence of suitable business models.

In the second part of the article I talk about the areas and activities in which solutions should be found at clinical and at societal level: doctors training, health economics and health literacy. These ideas call for huge change management efforts.

Finally, in the third and conclusive part of this article I change hat and I reconsider all the arguments I have found in the literature from the perspective and experience of being a person with Sjogren's Syndrome. I tend to sympathise with a "less is more" approach for the treatment of autoimmune diseases - that calls perhaps also for a reflection on the same foundations of evidence based medicine.

Bibliographic references are provided in the third part of the article.


A common way to describe these diseases - there are over 80 of them, from Multiple Sclerosis and Lupus to Rheumatoid arthritis, from Type 1 Diabetes to Sjogren's syndrome - is to say that the immune system turns against its own cells attacking them and destroying them as they were invaders or pathogens. We can surely accept it and use it, if it helps to grasp the idea but I do not like it too much and I would discourage people to go much further in this metaphor. It reminds me the words of a great poet, Vicente Alexaindre - who died of Tuberculosis in 1984, Nobel Prize for Literature and yet pretty much unknown, about love and death (...I want to be you, your blood, the roaring lava...). Instead, I like to say that even if it may be wounded and impaired, our immune system deserves great care. It knows us and loves us unconditionally but sometimes becomes confused and stuck in a bad mood: words count in the way we structure knowledge problems and shape solutions.

There is no actual resolutive treatment for autoimmune diseases, that manifest themselves in an infinite range of symptoms and severity grades. Similarly, medications that have been found useful to treat some symptoms over the last fifty years and are considered quite safe for somebody do not work at all for somebody else or have terrible side effects, triggering new untreatable conditions and infections that make life even worse.

The history of insulin for the treatment of Type 1 Diabetes and the promises of gene therapies have possibly influenced the whole of the pharmaceutical and scientific approaches to all of the known autoimmune diseases: insulin, discovered in the 1920s, was the first human protein produced chemically, since 1963, and then through a biotechnological process that recombines human cells, since 1978. In recent years, patients with Type 1 Diabetes have increasingly been offered also options of insulin pumps and bionic pancreas to manage blood sugar level, making the management of the disease very easy and almost completely compatible with the needs and pace of a normal social and family life.

However, in the case of many other autoimmune diseases, even when the adoption of a pre-diabetic diet seems helpful, there is no insulin pump or bionic pancreas to turn to. And the idea of a vaccine (vaccine against what?) able to transform the immune system in a bionic, invincible, super "control centre" for the entire human body is amazing but still science fiction at present.

In fact, having a vaccine would require a research programme with a timespan or horizon of decades. Instead, every day we hear of new hypothesis and experimental treatments based on stem cell transplants and immunosuppressant drugs offered as quick fixes. Both in America and in Europe the regulators tend to increase the number of authorisations given for biologics drugs that have proofed to be effective for the treatment of devastating conditions but at the same time they warn about the unknown, the dangerous or even the lethal side effects. Such drugs do not have a huge market and therefore the pressure of the industry is to investigate the possibility to offer them also as effective medications for other autoimmune diseases. Sometimes the trick works (drugs for rheumatoid arthritis turned out to be useful for other autoimmune diseases up to a certain level for instance), but most of the times it does not at all.

In sum, life expectancy has doubled in the last 150 years, but medical sciences have not progressed in that: experiments on human beings' immune systems and genetic materials are being designed and done with the same approach that was so important to eradicate infectious, contagious, acute diseases in the 18th Century. It doesn't work with the immune system. And why is that?

I considered at least a dozen and a half of recent systematic reviews or meta-analysis studies published in the last fifteen years that have tried to square the circle of what works in the management of chronic and autoimmune diseases. What has emerged is that researchers tend to identify elements of success in marginal factors to conclude that... more research is needed. But why?

Nutrition and diet should be considered the first line of intervention, as suggested by an increasing number of outsiders and "rebel" scientists - I endorse and discuss this direction in this article - but the majority of doctors still ignore the option, sometimes openly treated with reluctance or even hostility. Why?

Early diagnosis save lives and public money

Antibodies (also called immunoglobulins) - not always, but very much most of the times - show up in the blood stream: they are the traces left behind after the body's battles fought to neutralise all sorts of infections and inflammatory processes.

Researchers study in detail at microscopic level what this struggle may include or consist of: Initially displayed as membrane-bound receptors on the surface of B lymphocytes [B-cell receptors (BCRs)], they constitute a highly polymorphic class of glycoproteins, thereby accounting for the myriad of pathogenic antigens that they have to recognise and fight off. (Parola, 2018).

The inventory of an individual's B-cell receptors stays in the bone marrow but the practical confrontation with the various antigens (toxins, bacteria, viruses) the human body is exposed to can happen pretty much at random in any of the lymphoid organs (spleen, lymph nodes, mucosal lymphoid tissues, salivary glands, and so on). Etcetera etcetera.

I will not attempt here to engage with or explain this jargon any further. Let's stay with the common definition of autoimmune disease: the immune system, confused and overstressed because of a myriad of known and unknown reasons, does not distinguish anymore between real and fake intruders and attacks its own cells mistaken for pathogens.

To some extent, scientists are convinced that all the various known autoimmune diseases are just various instances of the same fundamental problem that causes a wide range of symptoms. In fact different autoimmune diseases often overlap in the same person or symptoms come and go interchangeably, go in remission, return in more serious fashion and so on and so forth.

While antibodies dynamics can surely tell a story of fascinating scientific advances to genetic researchers and medical students, for the million of people that suffer from autoimmune and immune system diseases, it just hurts. It can be just pain and deteriorated quality of life by the minute, affecting physical performance as well as cognitive function, emotional wellbeing and relationships, until an accelerated process of degeneration or failure occurs in one or more organs.

The first thing that surely demand urgent change in the management of autoimmune diseases is the preliminary screening and diagnosis: everybody even slightly or remotely suspected to have one of these conditions should immediately go through a blood test, checking their antibodies.

Without autoantibodies, it is much more difficult to come to a diagnosis, and without a diagnosis people affected with autoimmune diseases waste energy, time and public resources trying to reckon what is going on in their body, looking for the holy grail, ping-ponging among specialists in the hope of finding a cure for a constellation of symptoms. In doing so, they are often exposed to the risk of just falling into the trap of modern quackeries - what I called, in icm2re 6.5, the Little shop of horrors in a data cacophony, or iatrogenic death - that means they will became ill and die from taking drugs as prescribed in good faith by specialists.

Would it be better to speed up the diagnosis stage? Even if the screening was required for pretty much the entirety of the population there is a possibility that the national health service could save money.

People with a prompt diagnosis could make adjustments to their lives and save private and public resources for the better, preventing years of useless and costly examinations and consultations and see how to optimise treatments instead.

Unsolved, delayed clustering issues do not help

Classification is a way to structure problems and unable solutions. There would be no science and no knowledge without classification of objects and problems, ideas and case histories.

Autoimmune diseases share a number of characteristics with other chronic conditions, and mainly with cancer, because in all of these conditions there are "wrong" immune responses to pathogens, enzymes or other substances produced by the body.

However, the traditional classification, clustering or associations of autoimmune diseases with other "similar" and yet different conditions often contributes to confusion and misinformation non only among patients, but also among doctors and researchers and scientific journalists.

Everybody tends to adopt the terminology most convenient to the matter they are talking about in a certain scientific or research context that not necessarily focuses on people health and care: hence diseases that are fundamentally different (as far as lifestyles, quality of life, strength or medications and care needs are concerned) are grouped on the ground of criteria useful for cancer research, for biotechnology experiments or for just "business as usual" administration in primary care and hospitals.

To add more confusion, anybody diagnosed with an autoimmune disease redefines in his or her context what is chronic (managed and treated in some ways on a permanent basis) and what is acute, often called "flare up".

The same patients tend to accept (and emphasise as acceptable in their primary care contexts), a "constellation" of very much needed actions and remedies as advised by the specialists examining their various symptoms, in that returning into the healthcare system confused and contradictory feedback that have the effect of reinforcing some "evidence based" hypothesis without actually providing any consistent new evidence.

The experts who deal with the constant review of the International Classification of Diseases (ICD) at the World Health Organisation have been well aware of the need and the consequences of change in the definition of autoimmune diseases and chronic illnesses for a while: more and more international standards applied in the diagnosis and care of these conditions and very transparent criteria about the coding and classification would be helpful to both patients and practitioners in primary care, academic institutions and hospitals.

Until the 2016 edition, the WHO's ICD (version 10) still classified many known autoimmune conditions within the classes of diseases affecting the organs traditionally associated with the main symptoms of that condition. So several of them were defined, for instance, "diseases of the musculoskeletal system and connective tissue" because it is assumed that they all affect with variable degrees of pain, the bones, the joints and the muscles. "Certain disorders involving the immune mechanism" were however already isolated within IDC 10.

With its latest version, IDC 11 (WHO, 2019), expected to be fully implemented by 2022, the WHO classification has now introduced a very necessary main class for "diseases of the immune system": it is not unreasonable to expect that responsible healthcare professional will move quickly towards a huge change in approaching and managing - not just coding - these diseases in the coming years. Treatments experimented, offered or put forward for approval by pharmaceutical companies may start to follow new and alternative routes.

However, it is with a certain sadness that I am reading that instead of endorsing and accelerating the pace of adoption of IDC 11, that is completely accessible and browsable for free online, entire segments of the healthcare and medical professional communities are openly manifesting hostility towards it and lobbying against its implementation. Expect that changes within their systems, projects and programmes, software routines or training courses will be delayed, many says, complaining about the impossible pace of change (IDC 10, the previous version of the classification, remained in the drawers for many many years and it was eventually adopted only four years ago, in 2015). But this is another aspect of the absolute importance of managing change in the healthcare and medical research sector, calling for a radical mindset shift: I hope to see it sorted as soon as possible on a global scale.

Clinical trials for autoimmune diseases must be regulated

Browse the websites of the USA Federal and Drug Administration or the equivalent UK Medicines and Healthcare products Regulatory Agency (MHRA) and you will find how incredibly flourishing and exciting is this area of new drugs developments, in spite of the fact there is no available effective treatment for autoimmune diseases. The best option is therefore to tackle and manage the "constellation" of symptoms they cause, possibly proactively.

But the word "treatment" introduces us to another domain of confused options offered to patients, often without any acceptable and transparent governance and control, transforming human beings in... guinea pigs.

With many levels of nuisances, impairments or disabilities even among people with similar lifestyles, it is not a surprise that all autoimmune diseases have become the perfect field of experimentation for the short term programmes of pharmaceutical research and development.

Researchers looking for flexible formulas to be commercialised with short timeframes can aspire to make some assumption in the lab, run a clinical trial with autoimmune disease patients, publish very limited "scientific evidence" in support of this or that drug and obtain authorisation for the commercialisation of new drugs in few years. The portfolio of these "immune system modulators" starts to resemble cosmetics products.

But there is a but. And it is the emerging suspect and belief, among patients and doctors, that the more people with autoimmune diseases stay away from aggressive, intrusive drugs and from specialists' experimental therapies, the better and longer they can enjoy their life, in spite of potentially devastating symptoms and increased risks of complications.

What every patient has to come to term with is the fact that the causes of autoimmune diseases are unknown. However, it would be better to say that the causes are very uncertain and difficult to grasp in objective, standard and univocal terms but all the evidence gathered around these diseases talk about interactions between genetic, environmental and social factors.

Many patients know that the odd constellation of crazy symptoms they have been experiencing started at a certain point in their life, often after a physical or emotional breakdown, entering the menopause or because of a problematic infection or other health crisis. It is like the immune system did its best to protect us from major risks of failure at some point in life and since then it has remained penalised. Some people are diagnosed with the disease but if they are lucky they can barely notice they have an autoimmune condition in their daily live and barely experience any symptom at all for many years. Others' are so severely affected that lose their independence at a very early stage after they retire from work. Above all, women are affected with autoimmune diseases at the watershed moment of the menopause, as that was the moment in which the immune system eventually presents the bill!

There is also a consistent consensus about the possibility that viruses and bacteria contribute to these conditions but without so fare any convincing, ultimate demonstration (like the ones existing, for instance, linking the H.pylory bacteria with stomach and duodenal ulcers, or the Porphyromonas gingivalis bacteria with gum disease). This should be a major stream of research, being possible that from a successful encounter with a virus or bacterium responsible of puzzling the immune system, we eventually find the resolutive vaccine!

The fundamental uncertainty about aetiology of autoimmune diseases explains why experimental treatments that suppress, or try to suppress, the dysfunctional immune system leveraging on human engineered antibodies seems, at first, the only way forward.

Immunosuppressant drugs are currently offered in certain circumstances to treat autoimmune disorders like lupus, psoriasis, multiple sclerosis, rheumatoid arthritis, Chron's disease, Sjogren's Syndrome and more, in spite of not having any strong evidence of overall effectiveness against the possibility of even lethal side effects. But they seem to have a general good acceptance among patients to whom they are offered as a panacea.

The costly experiments are offered in the UK to some patients according to guidelines prepared by NICE, hospitals and NHS Trusts. However the interpretation of such guidelines vary considerably.

The logic of immunosuppressant drugs is always very invasive no matter where and how they come from and how they are administered: it is a bit like saying that since no oil arrives to the brakes of your car for unknown reasons, the best thing is to get rid of the brakes altogether (or partially) so that you do not feel any more panic driving the car with broken brakes. No more panic does not mean that you do not crash.

While immunosuppressants seem to have a big role to play in saving the life of people who receive transplanted organs, preventing rejections, the use of biologics to treat autoimmune diseases seems currently, most of the times, unjustified in terms of scientific evidence. It leaves many patients, who believe they have been very lucky to get approved for the new treatment, with a sad life in which not only there isn't any remission of the disease but further complications add on top of their compromised immune system.

Can a life as a guinea-pig sort out most of the problems for some people and provide interesting evidence for the advancement of medical science? at what price? Biologics treatment - with all the doubts on their efficacy in the long term and the adverse reactions they have already proved to cause - are very costly for the public purse.

Some individuals more easily than others understand, just listening to their bodies, that there are alternative choices that can be made, especially at different stages and ages, mostly depending on the level of information and health literacy they already have and their propensity to know more about self care.

Some just end up being exposed to elevated risks of complications and iatrogenic death, for the sake of "helping science".

The plant based diet should be mandatory

To conclude with a positive note the first part of this article, I must return to write in favour of the plant based diet I mentioned in other icm2re articles.

Immunonutrition is the less possible disturbing way to address an autoimmune disease, a choice everybody can safely turn to anytime and with immediate results (even without suffering from any disease) just to prevent health problems with ageing.

It is still a rare subject though, because the pharmaceutical industry, the healthcare system and even specialists (like gastroenterologists, dieticians, nephrologists) are not prepared to talk about it with patients.

For the last thirty years, hundreds of studies have demonstrated the role of diet to counterbalance, treat and even reverse immune system diseases, pointing toward the incredible efficacy and immediacy of results obtained avoiding animal proteins and often also proteins from legumes in autoimmune diseases. (Greger 2016, Cabot 2015). But such evidence is not liked by the food industry, by pharmaceutical companies and by the powerful farming stakeholders and, believe it or not, it is not even endorsed by the medical professionals in spite of strong clinical evidence accumulated since the 1960s (Campbell 2005, Lieberman 2015), and recently confirmed also by nutrigenomics experiments (Celiberto et al, 2018).

In practice, all major cell types of the immune system have been shown to undergo a switch in their metabolism dependent on the type of inflammatory stimulus and the availability of nutrients (mainly glucose), in their environment (Celiberto et al, 2018). This type of strong evidence supports the call for more immunonutrition choices. And yet many general practitioners and specialists ignore this route of treatment, discarded as eccentric.

The Cochrane library (the greatest worldwide network of medical researchers sharing what they know and what they are doing) shows, for instance, that at the time of writing this article, just a couple of dozens of clinical trials including immunonutrition experiments are ongoing, all pretty much related to cancer treatments.

Ignored by rheumatologists and nephrologists, relegated to the experimentalism of consumerism policies and health economics - more on this in the next part of this article - could immunonutrition become a growing field of interest for both academia and policy makers in the field of economics instead of medicine?

The number of experiments, journals and papers on plants-based diet, veganism and vegetarianism is on the rise as well as the general interest of the public and the media attention.

Unfortunately the same is true for the number of patients diagnosed with a mismatch disease, to use the terminology much divulged by Daniel Lieberman, author of one of the most successful books on the subject. (Lieberman, 2013).

I wonder how happier everybody could be if any diagnosis of immune system disease was to be followed by a ....compulsory plants based diet!