Fear/Courage Articles

Discern Ithaca from the siren song: innovation in medicine, between fear and courage

Accepting uncertainty is the key to having the courage to say and be cautious and overcome the fear we feel as doctors, nurses, citizens, health decision-makers.

Camilla Alderighi, Raffaele Rasoini.

Irccs Fondazione Don Carlo Gnocchi, Firenze

By July 2019June 24th, 2020No Comments


In an etymological sense, to innovate means “to alter the order of established things in order to do new things.” In history, innovation has always been closely related to the alternation between fear and courage. Indeed, these two feelings have often faced each other in history, and their dominance on the influence between humans and innovations has alternated. If, on the one hand, innovation evokes fear because it implies an alteration of the status quo, on the other it underlies another human inclination—the courage of the Homeric “overcoming limitations”—thanks to which, progress has repeatedly emerged throughout history.

If the feelings aroused by innovation have remained approximately the same over the centuries, the same cannot be said about the criteria for defining innovation, which have changed profoundly over time. Probably due to a combination of several factors, including the immediate, easy, and powerful dissemination of information through digital media—which Italian author Alessandro Baricco spoke of as “fast truths”—the huge economic interests at stake, and the continuous evolution of contemporary technology, nowadays the threshold for defining innovation has been greatly reduced. However, if the sensitivity of a definition grows, this frequently occurs at the expense of its specificity; thus, there is a risk that “novelty” becomes improperly synonymized with “progress”.

In medicine, the effects of this trend are palpable: in a study conducted at the University of Ottawa, it has been observed that the number of new scientific publications has increased to about 2.5 million each year [1]. The image that is presented to us, and that is deeply rooted in contemporary culture, is a science in continuous and positive progress, which we could even call “magnificent and progressive.” However, the image arising from the critical appraisal of this profusion of publications is very different.

In the medical field, each innovation should respect two fundamental criteria so to be defined “useful”: it must be supported by robust evidence and it must improve primary outcomes, such as life expectancy and quality of life. Only the achievement of these goals truly justifies a change of medical practice from the status quo. This is why, it’s necessary to carefully filter the profusion of scientific publications celebrating the progress allegedly offered by new treatments or diagnostic tests. Meta-research is about this, i.e. the rigorous study of the methods and contents of publications. Unfortunately, such research often does not convey reassuring results, even when it comes to publications with a high expected methodological level. For example, in a recent systematic review including 93 randomized clinical trials in cardiology published in six high-impact journals, a positive spin on statistically nonsignificant primary outcomes was found in 57% of abstracts and 67% of main texts of the published articles [2].

One of the negative aspects of this publication trend can be well expressed by the increasing reporting of “medical reversals,” a term coined by Vinay Prasad and Adam Cifu: “Medical reversal occurs when a new clinical trial — superior to predecessors by virtue of better controls, design, size, or endpoints — contradicts current clinical practice” [3]. In other words, when we take an innovation as good without investigating if it truly is so, we expose everyone to the risk that, when it is subsequently scrutinized under critical appraisal, this innovation will no longer prove to be good, and thus, it will be abandoned.

The most extensive summa of medical reversal recently published has shown that out of 3000 medical practices, about 400 are to be considered reversal [4]. The use of elastic stockings for the prevention of post-thrombotic syndrome and angio-TC coronary screening in diabetic patients are just a few examples of the medical reversal reported, that doctors should absorb and convey to patients.

To elucidate this phenomenon, in addition to the distorted amplification of health contents by the media, we are faced with the responsibility of those who practice and publish research without integrity. Such research may be conditioned by financial conflicts of interest or may be aimed at other purposes, such as increasing the academic curriculum, that are not focused on a real benefit for patients. The same applies to those institutions that, through simplified and abbreviated procedures, approve – with an insufficient evidence basis – some “innovative” drugs or medical devices that turn out later to carry no real benefit [5].

To amplify the hype around novelties without evidence is not an end in itself, but rather, it contributes to hijacking research funding in a distorted way and exposing institutions and doctors to false evidence. Above all, it contributes to creating patients’ narratives of hope that are often destined to be denied (but, like all hopes, are difficult to deny), with a consequent loss of confidence in the “system” among patients. Low value innovations that are grounded on a poor evidence base lead to low value care, but, mostly, mislead people about health choices.

When faced with any scientific innovation that is presented as “progress,” we should therefore critically reflect about it. This is one of the duties of the “medical conservative,” an expression coined by John Mandrola et al. [6], above all denoting an attitude that has been elevated to manifest the 21st-century physician. In the face of potentially unreliable innovations, a medical conservative has the courage of stepping back from the drift of superlatives and hype to critically appraise the benefits and risks that these alleged innovations exert on patients. Moreover, the medical conservative shares this knowledge—uncertainty included—with patients, or better, with one patient at a time. One of the duties of doctors, today, is therefore to identify and share with the community what information is grounded on incorrect bases and what, instead, can be a vehicle of authentic advancement. The dissemination of reliable information can be done through traditional scientific communication channels, such as medical journals, as well as through more flexible channels that are able to communicate “fast truths” and quick denials. For instance, on Twitter, the speed of critical appraisal of the medical literature, variety of comments, and multidisciplinary nature of members allows doctors to obtain a multifaceted photograph of the reliability of a new publication in a much shorter time and through the interaction of a much larger number of people than traditional dissemination channels involve. For doctors, Twitter is an innovation because it has changed the way in which part of the scientific community interconnects. In its best realization, it is an excellent tool for apprehending useful information/innovations.

We should go further and ask ourselves what is it that truly drives people to accept innovations uncritically. Beyond the most immediate (but not sufficient) argument that they do so because they lack the ability to engage in critical appraisal, it is also possible that they do this out of fear.

In his book, Liquid Fear, Zygmunt Bauman defines present-day society as the most technologically equipped in all of human history, but at the same time, afflicted like none before by feelings of insecurity and impotence: “Comprehension is born of the ability to manage. What we are not able to manage is ‘unknown’ to us; and the ‘unknown’ is frightening. Fear is another name we give to our defencelessness” [7]. In fact, due to the biological and existential variability permeating it, as well as the confusion generated by the system of false evidence and its intrinsic uncertainty, medicine is a territory that is deeply exposed to fear.

There is the fear of people, also healthy people, who, increasingly worried about their health, accept or require more diagnostic tests or treatments so far as to even being digitally monitored with regard to their physiological functions without any solid evidence demonstrating real benefits from this capillary “control” [8]. There is the fear of doctors, who, afraid of omitting a potentially effective treatment or the execution of a diagnostic test that could generate more information, neglect the possible unfavorable effects of that treatment or test. There is the fear in health systems and among institutional decision makers, who, to avoid denying people access to a treatment or diagnostic test (e.g., some types of screening) seem to underestimate its possible negative effects.

In medicine, uncertainty means that, in most cases, there is no right choice for everyone, but at the same time, there is a right choice for each one. Yet, it takes time to uncover the latter, to evaluate scientific evidence, and even more, to know who is in front of us as the patient, to understand and balance the individual advantages and disadvantages of a treatment or no treatment and define what is really important for that person.

Time seems to be one of the most needed advances. Will “innovation” be able to help us in this regard? The central thesis of Eric Topol’s latest book, Deep Medicine [9], focuses precisely on this issue: If innovation must be—in this case, referring to contemporary artificial intelligence systems—it must intervene and support us exactly where it is most needed, such as by addressing the current lack of time in the doctor–patient relationship.

The human journey is filled with innovations. It is not the innovation proper that we must fear, but only the possibility that no authentic value could result from it. Like Homer’s Ulysses, we all become excited about what we think can help us attain a better cure; however, just like Ulysses, we should have the courage to distinguish Ithaca from the song of the Sirens.

References
[1] Jinha AE. Article 50 million: An estimate of the number of scholarly articles in existence. Learned Publishing 2010;23:258-63.
[2] Khan MS, Lateef N, Siddiqi TJ, et al. Level and prevalence of spin in published cardiovascular randomized clinical trial reports with statistically nonsignificant primary outcomes: a systematic review. JAMA Netw Open 2019:2:e192622.
[3] Prasad V, Cifu A. Medical reversal: why we must raise the bar before adopting new technologies. Yale J Biol Med 2011;84:471-8.
[4] Herrera-Perez D, Haslam A, Crain T, et al. Meta-research: a comprehensive review of randomized clinical trials in three medical journals reveals 396 medical reversals.
eLife 2019;8:e45183.
[5] Gyawali B, Hey SP, Kesselheim AS. Assessment of the clinical benefit of cancer drugs receiving accelerated approval. JAMA Intern Med 2019; May 28.
[6] Mandrola J, Cifu A, Prasad V, Foy A. The case for being a medical conservative. Am J Med 2019 Mar 6. pii: S0002-9343(19)30167-6.
[7] Zygmunt Bauman. Liquid fear. Cambridge: Polity Press, 2006.
[8] Vogt H, Hofmann B, Getz L. The new holism: P4 systems medicine and the medicalization of health and life itself. Med Health Care Philos 2016;19:307-23.
[9] Eric Topol. Deep Medicine. New York: Basic Books, 2019.

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