Caveat medicus: Harrowing experiences of clinicians who identify and publish near-fatal oncology associated adverse drug reactions.

Abstract

6584 Background: Less than 1-10% of adverse drug reactions are reported. It is even more rare to find clinicians who choose to publish these reports in the literature. We identified clinicians who had treated a patient for an oncology-associated serious adverse drug reaction and published these findings. This is the first study that has investigated personal experiences of clinicians choosing to publish information about serious oncology-associated drug reactions they see in their patients. Methods: Clinicians treating individual patients who developed oncology-associated serious adverse drug events were asked to participate. Inclusion criteria included having index patient information, reporting case series, and being collaborative with investigators from two National Institutes of Health funded pharmacovigilance networks. Thirty-minute interviews addressed feedback from pharmaceutical manufacturers, FDA personnel, and academic leadership, and recommendations for improving pharmacovigilance. Responses were analyzed using constant comparative methods of qualitative analysis. Results: 18 clinicians met inclusion criteria and 14 interviewees are included. Toxicities included central nervous system infections, arterial/venous thromboembolism, gastrointestinal toxicity, cardiac arrhythmias, and cancer development/progression. These investigations were frequently followed by label warnings and/or convening of Food and Drug Administration (FDA) Advisory Committee reviews of safety findings. Five studies were disseminated in four high-impact factor medical journals (JAMA, Lancet, Annals of Internal Medicine, and New England Journal of Medicine). Six clinicians received feedback characterized as supportive from academic leaders, while four clinicians received feedback characterized as negative. Responses from pharmaceutical manufacturers were characterized as negative by 12 clinicians. Responses from FDA employees were characterized as negative by six clinicians. Three clinicians recommended that pharmacovigilance should include simplified clinician reporting systems. Conclusions: Our study finds that clinicians who published reports of serious oncology-associated drug reactions experienced negative feedback from pharmaceutical manufacturers. Feedback from FDA employees and academic clinicians were viewed as supportive by some and negative by others. Most clinicians recommended that future pharmacovigilance involve big data analyses.