News Media Coverage of FDA
Warnings on Pediatric
Antidepressant Use and Suicidality
AcademyHealth
Issues in Improving Behavioral Health Care for Children
Colleen L. Barry PhD
Susan H. Busch PhD
Yale University
June 29, 2009
*Research support from the National Institute of Mental Health (1 R01 MH 080883-01).
1
Objective
• After an 18-month investigation, FDA directed
pharmaceutical manufacturers to add a black box
warning to antidepressants regarding an increased risk
of suicidality in children in 2004
• Some have suggested news media played a critical role
in the sharp declines in pediatric antidepressant use that
followed the FDA warning
• Our objective: To evaluate the quality, content and
overall impression conveyed in news coverage of this
issue
2
Role of the News Media
•
Over half of American public describes news media as most
important source of health information
•
In situations where there is uncertainty over the risks and benefits of
medical care, the public looks to the news media to:
– Flag health care safety problems
– Interpret scientific data related to these risks
– Identify relevant experts to comment on how to weigh risks and benefits
•
Health care providers also rely at least in part on the news media for
obtaining timely health care information
•
Assessing the quality of news reporting is essential given prominent
role of the news media in conveying timely health risk information
3
Timeline of Major FDA Actions Related to
Pediatric Antidepressant Use and Suicide Risk
2003-2004
June 19, 2003:
FDA Statement
regarding
pediatric use
of Paxil
Jan
Feb
Mar
Apr
May
June
Oct. 27, 2003:
FDA Public
Health
Advisory
July
2003
Aug
Sept
Oct
Mar. 22,
2004: FDA
Public Health
Advisory
Nov
Dec
Jan
Feb
Oct. 15, 2004:
FDA Public
Health
Advisory on
Black Box
Warning
Sept 12-13,
2004: FDA
Advisory
Cmts Vote
Mar
Apr
May
June
July
Aug
Sept
Oct
Nov
2004
4
Dec
Evidence
On Suicide Risk:
•
•
•
FDA meta analysis concluded that the rate of suicidality in youth on
SSRIs twice that of placebo (4 vs. 2%)
Evidence from clinical trials has been criticized
Conflicting evidence from observational studies
On Efficacy of Antidepressants in Treating Pediatric
Depression:
•
•
•
•
Only fluoxetine (generic Prozac) and citalopram (generic Celexa)
had evidence showing effectiveness in treating children
Seven SSRIs were no better than placebo in 13 trials for major
depression in children
Only fluoxetine (generic Prozac) approved by the FDA for pediatric
depression treatment
Significant off-label use of other antidepressants
5
Data
• Census of news stories published in 10 of the highest
circulation print newspapers, three major television
networks and a major cable news network in 2003 and
2004 (N=167)
• News coverage selection
– Lexis-Nexis, Factiva, and newspaper online archives
• Search terms: suicide, antidepressant, children
– Sensitivity tests using additional terms (i.e., pediatric, suicidality, SSRI)
in combinations with our search terms
• 327 newspaper articles & 191 television transcripts met
search criteria
– Excluded editorials, corrections, book reviews, letters to editor,
business/stock, Q&A, duplicate wire, obituaries, if
antidepressants & suicidality were not focus, if children/
adolescents were not focus
6
Outcome Measures
(1) Measures
of quality in news reporting
– whether news story correctly described the association between
pediatric antidepressant use and suicidality (versus suicide)
– Whether news story included health messages emphasized in FDA
warnings:
• importance of monitoring a child using antidepressants
• importance of tapering during antidepressant discontinuation
• that fluoxetine was the only FDA approved antidepressant for kids
(2) Measures of content of new reporting – anecdotes and expert sources
– whether news story referenced an individual child/adolescent who it was
claimed was (a) harmed or (b) helped by antidepressant use
– Whether news story included a quote from an expert source suggesting
that (a) risks of pediatric antidepressant use outweigh benefits or (b)
benefits outweigh risks
(2) Measure of overall impression
– Whether news story left overall impression that: (a) risks of pediatric
antidepressant use outweigh benefits; (b) benefits outweigh risks, or (c)
neither
7
Methods
• Nine-item pilot tested coding instrument
• All news stories double-coded by study authors
– Inter-rater reliability for each item was greater than .80
• To resolve coding disputes, authors discussed and
reached agreement on final coding
Analysis
• We analyzed news coverage over the entire time period
and during 2-weeks following specific FDA actions
• We tested differences between proportions of print and
television news stories using logistic regression
• We adjust standard errors for lack of independence
within news source
8
News Stories on Pediatric
Antidepressant Use and Suicidality,
2003-2004
60
FDA convenes
advisory panel
40
Total News
Coverage
Boxed
warning
FDA
advisory
30
Paxil risk
disclosed
Newspaper
Coverage
FDA
advisory
20
Television
Coverage
2003
Dec
Nov
Oct
Sept
Aug
July
June
May
Apr
Mar
Feb
Jan
Dec
Nov
Oct
Sept
Aug
July
June
May
Apr
Mar
0
Feb
10
Jan
# News Media Stories
50
2004
9
News Media Coverage of Key Health
Messages Emphasized in FDA Warnings
News stories
2003-2004
News stories
in any two
week period
following
FDA action
News stories
from other
time periods
News stories in two week period
following specific FDA actions
3/22/04
advisory
9/12-13/04
panel mtg.
10/15/04
advisory
Mention data indicates an
increased risk of
suicidality
(versus suicide) (%)
97.6
98.7
96.6
100.0
100.0
100.0
Mention importance of
monitoring (%)
43.1
44.3
42.1
88.2
26.8
58.3
Mention that when
discontinuing, medication
should be tapered (%)
13.2
12.7
13.6
17.7
4.9
0.0
Mention fluoxetine only
FDA approved Rx
treatment for pediatric
depression (%)
40.1
34.2
45.5
17.7
39.0
33.3
N
167
79
88
17
41
12
10
Use of Anecdotes and Expert Source
Quotes by Type of News Source
News Stories
2003-2004
Print News
Stories
Television
News Stories
Individual child referenced
Does news story reference individual child/adolescent who was:
•
Harmed by antidepressant use? (%)
35.3
27.8
58.5**
•
Helped by antidepressant use? (%)
14.4
11.9
22.0*
•
Either harmed or helped by antidepressant use (%)
39.5
31.0
65.9***
Among news stories referencing individual child/adolescent either
harmed or helped (N=66):
•
Story mentions a child/adolescent who was harmed (%)
89.4
89.7
88.9
•
Story mentions a child/adolescent who was helped (%)
36.4
38.5
33.3
Expert source quoted
Does new story include quote from an expert source suggesting that:
•
Risks may outweigh benefits? (%)
20.4
23.8
9.8
•
Benefits may outweigh risks? (%)
32.3
31.8
34.2
•
Either risks outweigh benefits or benefits outweigh risks (%)
43.7
44.4
41.5
Among news stories including quote from an expert source suggesting
either risks outweigh benefits or benefits outweigh risks (N=73):
•
Story mentions risks outweigh benefits (%)
46.6
53.6
23.5
•
Story mentions benefits outweigh risks (%)
74.0
71.4
82.4
167
126
41
N
11
Overall Impression of Risks and Benefits
of Pediatric Antidepressant Use
News stories
2003-2004
News stories in two week period following
specific FDA actions
3/22/04
advisory
9/12-13/04
panel mtg.
10/15/04
advisory
Does news story leave the overall impression that:
•
Risks of pediatric antidepressant use outweigh benefits (%)
34.7
53.0
27.0
8.3
•
Benefits of pediatric antidepressant use outweigh risks (%)
3.6
0.0
0.0
0.0
•
Neither (%)
61.7
47.0
73.0
91.7
167
17
41
12
N
12
Summary of Findings
• Mixed evidence on quality of news reporting
– Nearly all news reports accurately described association between
pediatric antidepressant use and suicidality (vs. suicide)
– Other key health messages highlighted in FDA warnings often
absent from news reports
• News stories, in particular TV news, more likely to include
anecdotes of kids harmed than helped; while expert
sources were more likely to emphasis benefits over risks
• Majority of news stories conveyed neither the overall
impression that risks of pediatric antidepressant use
outweighed benefits nor that benefits outweighed risks
13
Limitations
• The public and medical professionals can learn about
health safety concerns via non-traditional news sources
(blogs, other internet news sites)
– Given current turmoil in the newspaper industry, the public is
likely to rely increasingly heavily on alternative sources of health
information in the future
• Study does not include local TV news, smaller
newspaper outlets
• While families’ exposure to risk and benefit information
via news media may explain subsequent treatment
declines, assessing this causal relationship is beyond
the scope of this study
14
Policy Implications
• Putting a health message in FDA warnings was not
sufficient to ensure its communication to the public, even
though this information might have mitigated risks
– Omissions in news coverage were actually reflected in treatment patterns
• Our finding of the reliance of TV news on anecdote is
consistent with prior research that TV news frames
coverage in more personal terms
– Given evidence that patients may disproportionately weigh anecdotal versus
statistical evidence, the use of anecdote of children harmed could potentially have
led to larger declines in pediatric AD use than would have otherwise occurred
• Greater emphasis on benefits of antidepressants by expert
sources could serve as a balance to use of anecdotes
– But, increasing attention to COI in medicine raise concern about journalists’ use of
expert sources in the absence of disclosure policies
– In this study, no news stories coded included specific information about whether
experts interviewed had specific COI (e.g., receiving industry funding)
– This is consistent with research reporting that news articles reporting on medication
studies often fail to report pharmaceutical company funding
15
Thank you
comments welcome:
colleen.barry@yale.edu
16
New Sources
• Newspapers
– USA Today, Wall Street Journal, New York Times, Los Angeles Times,
Washington Post, Chicago Tribune, New York Daily News, Philadelphia Inquirer,
Denver Post/Rocky Mountain News, Houston Chronicle
• Television networks
– ABC, NBC, CBS
• Cable television
– CNN
17