Making the Claim: The Diffusion of Risk Claims about Prescription Drugs

• In Event: 322 - Section on Medical Sociology Roundtable Session
  In Refereed Roundtable: Table 05. Pharmaceuticals

Abstract

This study shows that safety warnings about prescription drugs feed back into the system that may have provided the evidence initially used to justify the safety warning. It does so by inducing patients, physicians, and other healthcare providers to report adverse events that would otherwise not have been reported. The increase in reporting of adverse events associated with specific drugs causes drug safety scholars and regulators to detect reporting disproportionality, a signal that may subsequently be used as evidence upon which regulatory action can build. We find that the increase in reporting is limited to drugs that are categorically related - they treat the same disease - to the drug for which the safety warning was issued. Using the most comprehensive list of US approved drugs thus far compiled and relating the safety warnings associated with a sample of those drugs to more than 20 million drug-adverse event pairs reported to the Food and Drug Administration (FDA) between 1997 and 2013, we employ a regression discontinuity design to show how claims about the safety of a drug affect reporting ratios of other drugs and that the spread of - potentially non-relevant - claims is facilitated and bounded by the categorical hierarchies within which drugs are classified. This research addresses a broader sociological question about how claims about events may contaminate the meaning and understanding of other events along the lines of categorical order.

Author

• Mathijs de Vaan, Columbia University