Messages about black-box warnings: a comparative analysis of reports from the FDA and lay media in the US.

BACKGROUND: The US FDA and lay media are important sources of information for the public about the risks of adverse events associated with drugs, yet the quality of FDA and US lay media reports about medication 'black-box' warnings, which highlight potentially severe adverse events from medications, is unknown. OBJECTIVE: To determine and compare the content of FDA and US lay media reports about medication black-box warnings. METHODS: We assessed FDA and US lay media reports about medication black-box warnings published or aired between 1 January 2003 and 31 December 2007 for the presence of six core message components, including (i) the affected drug's brand name; (ii) generic name; (iii) treatment indication; (iv) reason for the black-box warning; (v) clinical recommendations for patients, such as warning signs and symptoms of the adverse effect addressed by the black-box warning; and (vi) encouragement to discuss the issue with a healthcare provider, and additional characteristics. RESULTS: FDA reports presented more core information than lay media reports (median 5 vs 3 message components; p < 0.001). FDA reports were more likely to mention generic names (84.6% vs 18.1%; p < 0.001) of affected drugs, while lay media reports less frequently detailed clinical recommendations for patients (43.9% vs 96.2%; p < 0.001). Only 10.6% of lay media reports encouraged patients to seek additional information from their healthcare provider, compared with 48.1% of FDA reports (p < 0.001). CONCLUSIONS: FDA and US lay media reports about medication black-box warnings presented different information. This may reflect a difference in underlying motivation for reporting of news about risks of adverse drug events. It may also indicate a lack of agreement and understanding about the best methods to communicate risk information to the public, thus indicating areas for future research.

The HPV vaccine and the media: how has the topic been covered and what are the effects on knowledge about the virus and cervical cancer?

OBJECTIVE: In June 2006, the first vaccine for HPV was approved by the FDA and media coverage about the topic increased significantly. This study sought to explore the nature of the coverage and whether knowledge about HPV was affected by it. METHODS: A content analysis, including 321 news stories from major newspapers, the AP wire and television news networks was conducted. A monthly RDD-recruited Internet survey with a national sample (n=3323) was used to assess changes in population knowledge. RESULTS: Twenty-three percent of stories did not mention the sexually transmitted nature of the disease and 80% left out information about the need for continued cervical cancer screening after vaccination. Exposure to health-related media content was significantly associated with knowledge about HPV, even controlling for baseline knowledge (OR=1.62, 95% CI=1.12-2.35). CONCLUSIONS: Changes in the volume of coverage over time were associated with knowledge about HPV, but the content analysis reveals that many of the stories were missing important information. PRACTICE IMPLICATIONS: Clinicians must consider the potential media source patients are using for HPV-related information in order to correct inaccurate or incomplete information that could affect health behavior.