Date of Award

January 2026

Document Type

Thesis

Degree Name

Medical Doctor (MD)

Department

Medicine

First Advisor

Joseph S. Ross

Abstract

Background: The quality and availability of health information consumed by the general public have undergone dramatic changes in the 21st century with the rise of digitization and the internet. These include the growth of direct-to-consumer (DTC) advertising of prescription drugs on television and online media, changes in health content on traditional news media platforms, and the propagation of health misinformation and disinformation on social media and other websites. Understanding the nature and sources of these changes can inform efforts and interventions aimed at improving the general public’s understanding of health information. One area of interest within regulated health communication is the informational quality of direct-to-consumer pharmaceutical advertising, which prior research has suggested has contained elements that can be misleading to consumers. An underexplored area of study is the informational quality of pharmaceutical advertisements particularly for drugs that are approved through special expedited approval approaches that are increasingly used by the U.S. Food and Drug Administration (FDA) such as breakthrough therapy designation, whose name has generated confusion for patients and physicians. A separate area of interest, within unregulated health communication, is the growth of unreliable news websites that publish health misinformation. While much attention has focused on strategies to curb the spread of such misinformation through social media content moderation, there is now growing interest in curbing advertising revenue sources of websites that repeatedly publish health misinformation.

Research Aims: The aim of Study 1 is to assess informational quality of a sample of DTC pharmaceutical advertisements for prescription drugs that received FDA breakthrough therapy designation and identify policy recommendations relevant to the regulation of DTC pharmaceutical advertising. The aim of Study 2 is to inform strategies for addressing rising health misinformation prevalence by describing advertisement revenue sources for websites that publish health misinformation.

Research Questions: To what extent do television advertisements for prescription drugs granted FDA breakthrough therapy designation contain elements that may be misleading for health information consumers (Study 1)? What are the amounts and sources of payments made by government and health organizations to place advertisements on news websites identified for publishing health misinformation (Study 2)?

Methods: For Study 1, we developed a prespecified qualitative coding scheme and used it to assess various characteristics of informational quality of a sample of television advertisements that ran from 2012-2021 for drugs that received FDA breakthrough therapy designation. For Study 2, we merged two commercial databases to characterize payments made by government and health organizations from 2021 to 2024 to place advertisements on news websites identified for publishing health misinformation.

Results: In Study 1, we found that in a sample of 57 advertisements for prescription drugs, 5 (8.8%) used the word “breakthrough,” and several advertisements demonstrated characteristics out of compliance with recent FDA guidance for non-misleading advertising including 6 (10.5%) that described benefit quantitatively but without reporting control group statistics. In Study 2, we found that government and health organizations accounted for $25,749,961 (10.6%) of the $336,428,230 in estimated payments from 2021 to 2024 made to place advertisements on a sample of 11 websites identified for publishing health misinformation.

Implications: Our findings in Study 1, taken with previous findings, highlight issues in the informational quality of direct-to-consumer pharmaceutical advertising, including suboptimal representations of benefit and use of the word breakthrough in instances where it can be misleading. Possible interventions include more proactive FDA review of promotional materials to assess compliance with existing guidance. Our findings in Study 2 identify the possibly inadvertent role that government and health organizations may be playing in the funding of health misinformation websites. Government and health organizations may consider instituting stronger restrictions on their advertisement placements to avoid websites known to publish misinformation.

Comments

This thesis is restricted to Yale network users only. It will be made publicly available on 08/01/2026

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