LAUSR.org creates dashboard-style pages of related content for over 1.5 million academic articles. Sign Up to like articles & get recommendations!

When Off‐Label Prescribing Becomes Politicized: Do No Harm

Photo by owenbeard from unsplash

We are living in times of extreme polarization and the politization of medical and scientific facts, and no one seems to be immune from this “propaganda.” The late senator Daniel… Click to show full abstract

We are living in times of extreme polarization and the politization of medical and scientific facts, and no one seems to be immune from this “propaganda.” The late senator Daniel Patrick Moynihan said, “Everyone is entitled to his own opinion, but not his own facts.” The COVID-19 pandemic in the United States has resulted in a myriad of expert and non-expert assertions of demonstrably false statements regarding public health, scientific facts, biomedical research, and medical treatments. At the same time, our appreciation of the value of certain public health measures, such as mask wearing or social distancing, changed as new information became available. However, as a result of a lack of understanding about the dynamic nature of science and the iterative quality of scientific inquiry, the public was left confused, and previously trusted sources of guidance, such as the Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Diseases (NIAID), have lost credibility among many. Although public mistrust was exacerbated by the CDC’s unforced error discouraging “people who are well [from] wearing a face mask to protect themselves from respiratory diseases, including COVID-19,”1 the problem is far larger than this and has left a vacuum, which the public has filled with dubious statements from credentialed and lay sources. Further compounded by a general distrust of official news sources, many in the public have sought scientific and medical information from unvalidated sources like social media. And it is abundantly clear that many of the social media sources have prioritized clicks over truth. A lack of understanding about the dynamic nature of science and the “hyperpoliticization” of public health facts has also affected the prescribing practices of physicians, especially off-label prescribing for COVID-19-related conditions. Off-label use enables physicians to prescribe drugs for uses beyond US Food and Drug Administration (FDA)–approved indications, including the unstudied treatment of different diseases or age groups and the use of alternative dosing or routes of administration. Although pharmaceutical companies are not allowed to advertise a drug for any purpose other than its approved indication, off-label use is generally legal unless it violates ethical guidelines and safety regulations. The regulatory approval for each specific drug indication requires a critical mass of evidence that is costly to generate. There are not enough resources or enough time to test every drug for every potential indication, especially during a pandemicwhen time is of the essence, resources are scarce, and medical evidence and scientific understanding is evolving with the disease. Therefore, the regulatory approach to

Keywords: prescribing becomes; public health; becomes politicized; label prescribing; drug

Journal Title: Journal of Clinical Pharmacology
Year Published: 2022

Link to full text (if available)


Share on Social Media:                               Sign Up to like & get
recommendations!

Related content

More Information              News              Social Media              Video              Recommended



                Click one of the above tabs to view related content.