icm2re logo. icm2:re (I Changed My Mind Reviewing Everything) is an  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.


Chronological Index | Subject Index

Linked up and pitfalls down

On the creation of databases

How to cite this article?
Longo, Brunella (2021). Linked up and pitfalls down. On the creation of databases. icm2re [I Changed my Mind Reviewing Everything ISSN 2059-688X (Print)], 10.2 (February). http://www.icm2re.com/2021-2.html

How to cite this article?
Longo, Brunella (2021). Linked up and pitfalls down. On the creation of databases. icm2re [I Changed my Mind Reviewing Everything ISSN 2059-688X (Online)], 10.2 (February). http://www.icm2re.com/2021-2.html

This overlap between formal premises and actual behavior is, I assert, of quite dreadful importance today. We face a world which is threatened not only with disorganization of many kinds, but also with the destruction of its environment, and we, today, are still unable to think clearly about the relations between an organism and its environment. What sort of a thing is this, which we call 'organism plus environment?' [...]
What we mean by information - the elementary unit of information - is a difference which makes a difference.
- Gregory Bateson, 1970

London, 22 February 2021 - The availability of primary data can make a difference for any scientific progress. Coding objects, experiences and facts into structured formats is essential to the creation and transmission of knowledge. However, the existence of coded data would be useless without an underpinning classification that allows us to handle them, to make problems or phenomena visible so that we can conceptualise new solutions.

Extraordinary examples of collections of data that structure the knowledge and the reality we live in come from all sectors and disciplines. Without the stubborn interest of an Englishman, John Graunt, in parishes' registers of deaths in the 1660s the history of demographics as well as life insurance and the whole application of statistics to public health would have been totally different - or not even existing.

With the creation of large repositories of classical texts available in machine-readable formats, since the 1980s, the field of humanities has changed dramatically: scholars started to search words and lists of concordances and see their objects of study in different perspectives.

The world of medicine, of course, is deeply rooted into the existence of databases and their classifications. The International classification of diseases (IDC) or the Nursing Interventions Classification (NIC), to name just a couple, are part of an information infrastructure that underpins all sorts of medical training curricula, health policies, treatment protocols, laws and regulations, medical procedures, budgeting and accounting systems for hospitals or other software systems, most of the times in implicit ways.

Classification schemes that are embedded within databases widely used in our society are invisible, indisputable and not very subject to public debates. Only in recent decades, socio-cultural trends, new legal obligations and the pressure of new information and communication technologies available to society at large have started to lift the veal that conceal the governance of many databases, maintained and controlled by experts and bureaucrats, to the public opinion.

It is therefore possible, now more often than in the past, to see how often we make illusory associations (we love to believe in magic and serendipity after all!) and see or not see cause-effect relationships at all times, both when the correlations actually exist and also when they do not. This of course causes enormous turmoil in the public discourse around health policies and science, with everybody trying to pull the data in their direction, but also among scientists.

It is something I was fascinated by as a teenager and later on working on its technicalities and complexity as a librarian, an ICT manager and an information management consultant. The humble task of curating data, slightly changing categories, adding commons, finding patterns, deleting question marks and so on and so fort is immensely useful. It is in fact only with very structured and curated collection of data that new knowledge can be discovered in a correct and reliable way - no matter if speeded up and enhanced by artificial intelligence.

Filling the gap about autoimmune diseases

The Covid-19 pandemic may cause an acceleration of discoveries in immunology without precedents. In a previous article in three parts I have mentioned some of the relatively recent advances in the classification, understanding and treatment of autoimmune diseases. Apart from Diabetes, for the over 80 of these diseases there is no effective cure other than self-care and experimental biological treatments that suppress the immune system altogether.

We still do not know precisely what, in the first instance, causes the immune system to develop abnormal reactions to a wide range of substances, or responses to life events that are stressful to the point of causing chronic harm to the human body, often in systemic ways, or triggering cancer and sudden organs failures or heart attacks.

Can the pandemic help understanding the interactions between Covid-19, its experimental medications and vaccines and other conditions of the immune system?

The relationship between vaccines and autoimmune diseases has been investigated consistently since the 1990s. But without any conclusive findings so far.

Few years ago, researchers (Vadalà et al 2017) reviewed the subject and found that "In the last decade, reports have accumulated on various autoimmune disorders [...] following vaccination". It seems that the link between autoimmune diseases and vaccination has been debated so far in inconclusive terms but for having identified possible biological mechanisms by "which vaccines can cause autoimmune reactions. The individuals who might be susceptible to develop these reactions could be especially not only those with previous post-vaccination phenomena and those with allergies but also individuals who are prone to develop autoimmune diseases, such as those with a family history of autoimmunity or with known autoantibodies, and the genetic predisposed individuals."

Other researchers have investigated the link between Hepatitis B vaccination and the risk of multiple sclerosis, or between type1 diabetes and HIB vaccine (Wraith 2003).

For some diseases there is a convincing evidence that the vaccination has triggered an abnormal autoimmune response (Stowe 2009). In other circumstances the correlation is not convincing at all. Much of the uncertainty, not surprisingly, is due to the fact that there are limited coded events so that robust, correct correlations cannot be drawn.

Last year, a group of international experts in immunology (Rodigrues et al, 2020) went further and considered similarities between autoimmune diseases and Covid-19, starting from the evidence that the best therapies for severe and critical Covid patients consist of immunomodulatory drugs, exactly the same treatment used by patients of rheumatoid arthritis, lupus and other autoimmune diseases. They asked the question if Covid-19 could not be considered in itself an autoimmune disease and not just a viral infection. They concluded that "personalized approaches including genotypification of risk genes and evaluation of risk factors for autoimmunity (i.e., familial autoimmunity) must be also considered in the current development of vaccines".

These words sound terrifically wise advice to me. But what do the specialists think? For all of us poorly educated in biology and virology ideas of new possible routes for studying the immune system seem perfectly fine but they may be causing earthquakes within scientific circles that do not want to see their established classifications challenged. I know a couple of academics that could have a heart attack if asked in public questions like "What is the actual scientific evidence that a virus is a virus and not something else?"

In sum, more data about the consequences of the worldwide Covid-19 vaccination exercise can lead to an entirely new world of ideas about immunology. Discoveries about the causes of autoimmune diseases could be around the corner.

Databases collecting data on side effects to the Covid-19 vaccines are likely to become the first worldwide big data repository available to study innumerable possible correlations between vaccines and autoimmune diseases.

Coding data about side effects

The Covid-19 vaccines available at the moment have been approved and are being approved for use by major regulatory agencies around the World through emergency procedures.

Extraordinarily effective in fighting the global public health emergency, reducing the number of cases requiring hospitalisation and the number of deaths, the Covid-19 vaccines have not been tested in people with systemic autoimmune diseases.

A recent study (Velikova and Georgiev 2021) concluded that "real-world data on COVID-19 vaccines in patients with autoimmune inflammatory diseases tend to zero. The exclusion criteria for the two currently approved [in the USA, as of December 2020] mRNA vaccines at different stages of the study included autoimmune diseases. Interestingly, the US Food and Drug Administration (FDA) considered that there was a possibility that the vaccine had contributed to the onset of rheumatoid arthritis." [the authors refer here to FDA 2020 about Moderna.]

Since there are no explicit data, at this stage, from the trials that led the current vaccines to be approved, once again an important source of rough and nonetheless very relevant information are the databases collecting coded information about adverse reactions or side effects that should be made public and managed according to the best available standards.

The USA Vaccine Adverse Event Reporting System and the European Union's EudraVigilance database represent two excellent models to follow. These databases collect possible side effects or adverse reactions to all sort of medications, including vaccines.

It is extremely worrying for me to learn that we in the UK, following new post Brexit policies, could stop contributing to the EU collection of data - but I hope I misunderstood the new Government policy in this sector. After all, it is true that all my ten years long efforts to be employed in the Civil Service have failed! I do not understand why a Global Britain must withdraw its participation and contributions to Global databases of side effects of medicines.

Answering a call from international experts, the World Health Organisation has rapidly approved also a compensatory programme for damages caused by Covax, the WHO Covid-19 vaccination programme. This legal step should reassure and justify further investments in new databases that have to collect data about adverse events following the vaccination from an immensely varied and large population at worldwide level.

The scale of the exercise is unprecedented. May the love of scientific knowledge make a difference.

References

(1970) Bateson, G. Form, substance, and difference, Alfred Korzybski Memorial Lecture. This lecture, prepared by Gregory Bateson under a Career Development Award he received from the National Institute of Mental Health, was initially published within a series of papers by the Oceanic Institute, Hawaii. It has been digitised and I found the original text accessible from the website of the The Institute of General Semantics. The essay was re-published in 2015 in the IGS "ETC: A Review of General Semantics", 72, no. 1 (2015): 90-104.

(2003) Wraith DC, Goldman M, Lambert PH. Vaccination and autoimmune 
disease: what is the evidence? Lancet. 2003;362(9396):1659–66.


(2009) Stowe J et al, Investigation of the temporal association of Guillain-Barre syndrome with influenza vaccine and influenza like illness using the United Kingdom General Practice Research Database. Am J Epidemiol. 2009;169(3):382–8.

(2017) Vadalà, M et al, Vaccination and autoimmune diseases: is prevention of adverse health effects on the horizon? EPMA Journal (2017) 8:295–311 DOI 10.1007/s13167-017-0101-y

(2020) Rodríguez, Y et al, Autoinflammatory and autoimmune conditions at the crossroad of COVID- 19, in Journal of Autoimmunity 114 (2020) 102506 https://doi.org/10.1016/j.jaut.2020.102506

(2020) US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee Meeting. FDA Briefing Document Moderna COVID-19 Vaccine. Available from https://www.fda.gov/media/144434/download

(2021) Velikova, T, · Georgiev, T, SARS‐CoV‐2 vaccines and autoimmune diseases amidst the COVID‐19 crisis, in Rheumatology International https://doi.org/10.1007/s00296-021-04792-9. Published online 31 January 2021.