Abstract

We used the framework of communicating uncertainty and information subsidies to examine the efficacy claims about the female condom Reality, regarding unplanned pregnancy and HIV/STI prevention that were made in the manufacturer’s news releases, U.S. Food and Drug Administration pre-market approval news release and in wire service stories and newspaper stories from 1992 – 1993. The efficacy claims were juxtaposed with the empirical evidence regarding the efficacy of the female condom, as well as with the U.S. Food and Drug Administration (FDA) regulations. Qualitative content analysis suggested that the FDA’s efficacy claims as compared to the manufacturer’s claims dominated newspaper and wire service stories during the time female condom received pre-market approval. A majority of the news articles did not present a balanced or an accurate picture of the female condom’s efficacy. The findings suggest the contested nature of the efficacy claims as evidenced by how they were represented in the news media. The study also highlights the challenges of communicating uncertainty about a medical device when scientists themselves seem to disagree on the manageability of the uncertainty.

Highlights

  • People rely on news sources for health information, especially to translate jargon-infused complex information to more readily understood information (Parrott & Condit, 1996)

  • Why would the head of a federal agency responsible for the regulation and approval of medical devices suggest uncertainty about the efficacy of a device that it had approved? The goal of this study is to examine various efficacy claims made regarding the female condom by the Food and Drug Administration (FDA), the manufacturer, and the empirical evidence and to examine how the various claims were reported in the news media

  • The booklet specifies that the packaging for male condoms needs instructions for use, as well as information such as an AIDS prevention message and the intended use(s), and whether the device is for disease and/or pregnancy prevention

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Summary

Introduction

People rely on news sources for health information, especially to translate jargon-infused complex information to more readily understood information (Parrott & Condit, 1996) This includes information about new medical technologies and devices. Chatterjee and Markham Shaw (2012) reported that the FDA commissioner David Kessler, when announcing the approval of the female condom, was quoted as saying that the male latex condom remained the best choice against AIDS and STIs protection. They suggested, “...when credible sources frame a new technology in a negative light, early adopters may form corresponding negative impressions” They suggested, “...when credible sources frame a new technology in a negative light, early adopters may form corresponding negative impressions” (p. 11)

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