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The International Journal of Risk & Safety in Medicine: Past and future

Reminiscences of the retiring Editor-in-Chief: I. Ralph Edwards

After some long consideration, I have decided, with much sadness, that I should relinquish my post as Editor-in-Chief of the unique International Journal of Risk & Safety in Medicine (JRSM). There are very few journals that have as their main aim to present data and research that specifically seeks to consider the evidence for at the right balance of effectiveness/benefit against risk/harm for clinical treatments used in everyday practice. We have sought to encourage greater consideration of the evidence base of which treatments/managements will best achieve the short- and long-term overall outcomes for patients.

This has been a most important goal for me, but I shall be 80 years old in March and I am fast being left behind in my knowledge of the range of treatments used in today’s medical practice. I have concurrently found that I have not been able to find suitable reviewers for such a broad task.

The publisher (Axana Scherbeijn at IOS Press) and I have spent some time looking for a suitable replacement and we agreed on a person, as they say in the UK, ‘on our doorstep’. Liliya Eugenevna Ziganshina has been an Editorial Board Member for JRSM since 2004 and an Associate Editor since 2020, but has been busy with many other matters than this journal. I have more recently been keeping her increasingly busy and both Axana and myself have been delighted with her achievements with us and were delighted when she expressed interest in the work.

I wish to emphasize a few things before I leave my post, and I hope I will be able to think of them and write them when I recall them all!

The first is a reinforcement and plea to think very carefully about effectiveness/benefit against risk/harm. I hear reports from all over the world, not so many, but they worry me since they are about two matters: (1) clinical care failures that could be avoided with what I would call basic knowledge and (2) experiences that should be reported to aid others when there is no evidence readily available on the Internet. The main causes of these problems seem to be lack of time to pay proper attention to the starting symptoms and follow up; reliance on laboratory tests only rather than an assessment of clinical disease attributes and progress against the results of appropriate tests; and having too narrow an approach to the context of patients in their environment and overall histories.

I mention the problems above, occurring in general clinical care globally, to emphasise the importance of JRSM and to comment on some very positive points, but first of all about two old friends - Graham Dukes and Chris van Boxtel.

Graham was the founding editor of JRSM and being both trained in medicine and law was only too well aware of the onus on those who make life and death decisions about other, perhaps dependent, people. On the other hand, everyone is prone to errors and the main issue is whether they have acted with ‘due diligence’ as is required of any health care practitioner. In appearing in many legal situations to give expert advice on medical care matters, Graham recognized the gap between a profession that has patient care as its vocation and one that called upon to adjudicate on that same professional performance. Graham has written and spoken wisely on the needs of both professions to understand what a reasonably high expectation of clinical care should be, and to understand the interacting fields of both professions’ behaviour.

Graham and I had many discussions about misunderstandings between clinicians and lawyers. Common challenges to understanding are the differences between benefit and risk, which are essentially a value judgement made by an individual patient. These are not the same things as effectiveness and harm data, which are based on scientific research plus published, described occurrences. Just how far can one expect a medical practitioner to know about a particular patient and then decide on the best management for each of them? That is a major challenge and it is most important that the legal profession understands the complexities of it in their adjudication of medical errors.

‘Drug Benefits and Risks: International Textbook of Clinical Pharmacology’ was edited by Christoffel Jos van Boxtel, Budiono Santoso, and I. Ralph Edwards. It was our joint effort to emphasise this complexity of decisions in clinical care and with what we hoped were good examples and tips about how they might be considered in daily practice. It was a popular book for a while. Sadly, however, Chris began to have health problems so that he was unable to continue with a new edition and maintain his other work and eventually including editing JRSM. He was a wonderful person to work with and on his passing, I wrote:

‘My reflections about Chris would be his patience, humility and his sense of humour. I would pay tribute to his search for a way to make and keep clinical pharmacology a very relevant discipline to the humane treatment of patients as individuals. Over 15 years Chris dedicated to the International Journal of Risk and Safety in Medicine as the Editor-in-Chief and helped to develop it. He published many important articles, some of which were featured in BBC documentaries.’

It has been an honour to follow in the footsteps of Graham and Chris and I am much heartened to see that with the unfailing support of, first, Marion Lilley and now the intelligent, cheerful and forgiving Axana Scherbeijn (she has been invaluable in keeping me on the right track), the journal is more known and recognized globally, receives more papers from many countries and has a strengthening readership.

Whilst it is an undeniable fact that harm from medical care occurs, it is really heartening that so many papers about improving clinical care are sent to JRSM for consideration but there is the unfortunate paradox that we cannot accept all of them and even some of those of high quality. There are many that show that there is increased awareness of risk and benefit issues, which has encouraged many authors basing their own work on learning from publications elsewhere. These papers are useful and important in passing on lessons learned around the world and then used locally to benefit populations in many countries. It is unfortunate that, however good these papers may be, an international journal cannot accept many of those that do not have a novel methodology nor significantly different results. Perhaps in the future they could be summarized and sent in as letters or short reports.

I am, however, proud to have played a small part in being able to make public many other different and unusual research findings and new, practical clinical ideas to the wider clinical world: it is a pleasure to see so much innovation.

Finally, I will say again how privileged I have been in working with such fine people at IOS Press and others as editors, reviewers and authors. Marie Edwards Lindquist has been active mostly behind the scenes. She did not wish to be thanked but I do so as my guiding light in so many matters ranging from making me just about able to manage the software I need to use, to editing my editorials (!), and to providing me with essential information, of which she has a massive store.

We both wish IOS Press, JRSM and all of you a happy and successful future.

Warm greetings from the new Editor-in-Chief: Liliya Eugenevna Ziganshina

It is a unique privilege and enormous responsibility for me to be honored to follow these traditions of the most outstanding team of JRSM editors: Graham, Chris and Ralph. The journal has always had a huge impact on me, on my life as a whole, my understanding of work, research and its values.

I have been with the journal since 2003, when I first met Prof. Christoffel J. van Boxtel, the Editor-in-Chief at that time. It was my very first WHO meeting in Geneva. It was the Expert Committee on Selection and Use of Essential Medicines meeting, to which the Director of the Department of Essential Medicines, Dr. Hans V. Hogerzeil, invited me in a capacity of a temporary adviser. I was lucky to receive a seat around the Committee table right next to Prof. van Boxtel and we had a fantastic chance to discuss all the agenda items also between ourselves, and more. And these were remarkable memorable discussions!

The most exciting and dear memory is that we shared the understanding of medicine value and selection principles based on the balance of a medicine’s benefits and harms, supported by research evidence, and ultimately for the best possible health outcomes of patients. This meeting became a very important event to me, life-turning indeed.

Prof. van Boxtel invited me to contribute papers to JRSM, then to review submissions and to write book reviews and later to join the Editorial Board. All these assignments became a wonderful learning curve to me, shaping my critical thinking and deeper understanding of not only the discipline of Clinical Pharmacology, but also the entire Medicines field, Medicine and Health in the societal perspective of all the challenges of risks we increasingly face, particularly nowadays.

New WHO Expert Committee meetings followed and I had the privilege to work on a short-term contract at the Department of Dr. Hans H.V. Hogerzeil. There in Geneva I met Professor I. Ralph Edwards, the first Director of Uppsala Monitoring Centre - the WHO Collaborating Centre for International Drug Monitoring, which had more than 400,000,000 case reports of people who were damaged by drugs, and the inaugural President of the International Society of Pharmacovigilance. Professor I. Ralph Edwards together with Marie Edwards Lindquist edited the book “Pharmacovigilance Critique and Ways Forward”. I am absolutely privileged to be working with and learning from Ralph, learning on pharmacovigilance, the principles of safety in medicine and the art and science of the balances of benefits and harms. Ralphs’s ideas of responsible ways of doing safety studies, of openness and transparency in risks and benefits research, which have been shaping JRSM recently, become my new universities. Ralph’s lessons on socially responsible research, on looking for the ways in which people investigate evidence and his plea for long-term thinking will help us all in JRSM.

JRSM is outstanding and unique in its fascinating spirit of collaboration between editors, reviewers, authors, and the publisher allowing for great opportunities to young authors from all over the globe to learn and improve their research to the level of prestigious international publication. The incredibly infectious commitment to safety of interventions in health, particularly drug interventions, makes the journal even more important in the current environment of more and more health technologies with fast-track decisions, approvals, and implementations with less and less robust research evidence.

Through the years, the journal supported QiQUM (Quality information for Quality Use of Medicines) conferences in Kazan, Russia (2005; 2010; 2015). For the last QiQUM 2015 conference, which launched Cochrane Russia, Chris and Marion Lilley dedicated a special JRSM issue to the conference proceedings of participants. Since then we have been developing Cochrane Russia activities just exactly in the vision and mission of JRSM. And I was even lucky to meet once Dr. Graham Dukes (M.N.G. Dukes) at the International Conference “Selling sickness” in Amsterdam, 2010.

In our turbulent times, we hope that we could assure the respected journal audiences that we will put every humble effort in the continuity of the JRSM mission. The continued gentle guidance, patience and wisdom from Ralph and Axana, and warm support from the Editorial Board will help me pass through the challenges.

Within the new challenges of emerging infections, pandemics, health emergencies and crises with the flooding of mis- and disinformation JRSM keeps providing the global health community with the unique opportunity to publish and contribute to more safety in medicine for better health of all.

May I heartily thank Ralph and Axana for putting trust in me. Only together we will make it work.

Liliya Eugenevna Ziganshina, I. Ralph Edwards and Axana Scherbeijn