The current pharmacovigilance system, despite its well-known limitations, is built on procedures and automated processes that tend toward what has been described as an “institutionalized trivialization of risk.”
During drug development, pharmaceutical companies are naturally inclined to emphasize the benefits of a medicine while isolating or even underestimating potential adverse events. Participants enrolled in clinical studies, who trust their healthcare teams, may be less likely to emphasize side effects. Researchers themselves may become desensitized to risks, which they routinely record and classify.
During the subsequent post-marketing phase, adverse reactions are managed through reporting systems that anonymize and de-identify cases, transforming individual experiences into statistical representations of hypothetical risk. As a result, the risks associated with a medicine become highly abstract and appear relatively “normal.”
However, those same risks remain very real and can be a source of significant suffering for the individuals who experience them. Furthermore, they may receive substantial public attention when shared on a platform with billions of users such as YouTube.
The case of fluoroquinolones
An interesting example of adverse reaction reporting through YouTube involves fluoroquinolones, a class of broad-spectrum antibiotics widely prescribed in the United States.
Over the past 25 years, these medicines have been associated with significant adverse effects, including peripheral neuropathy, liver disorders, cardiovascular and gastrointestinal complications, stroke, chronic pain, insomnia, cognitive impairment, and mood disorders.
From a regulatory perspective, these reports have been systematically collected and evaluated, resulting in the issuance of several product safety warnings. Nevertheless, these warnings did not lead to a substantial decrease in prescribing or consumption.
Similarly, reports of adverse reactions did not disappear. This was reflected in 60 YouTube videos published between 2017 and 2019 in which 29 individuals described the side effects they experienced after taking fluoroquinolones, some of which they described as severely debilitating.
Created in the form of vlogs, these videos represent an example of “risk dramatization.” They focus on the symptoms experienced, the often desperate search for answers, and the discovery—through online forums and articles—of a large community of individuals who reported similar experiences following fluoroquinolone use.
Official and lay pharmacovigilance: how can they complement each other?
The fluoroquinolone example illustrates the significant differences in how adverse reactions can be perceived and communicated. Whereas traditional pharmacovigilance tends to trivialize risk through abstraction and statistical analysis, social-media-based “lay pharmacovigilance” often dramatizes risk through personal narratives and lived experiences.
Official pharmacovigilance is built by experts who isolate information, manage and discuss it as data, and communicate it as potential or hypothetical risks.
By contrast, lay pharmacovigilance consists of the direct and often painful account of adverse events by individuals who have experienced them firsthand. In this context, the risk is communicated as immediate, personal, and real.
Both approaches tend toward opposite extremes and should not be considered in isolation. Instead, a more balanced and objective understanding of drug safety could emerge by integrating the perspectives offered by both systems.
It is therefore important to recognize the role of YouTube—and other social media platforms—as a new source of pharmacovigilance data.
Such a shift is facilitated by the modern digital environment, where individuals can generate information, discussions, and advocacy movements through social media, while new technologies enable the analysis of vast amounts of user-generated content.
Integrating official pharmacovigilance data with information generated by patients and users could ultimately provide the public—not only pharmaceutical companies and regulators—with a stronger and more direct voice in discussions about medicine safety.
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