Evidence map›Paper›PMID 23942130›Full record

ArticleProceedings of the National Academy of Sciences of the United States of America2013

The Drug Facts Box: Improving the communication of prescription drug information.

Lisa M Schwartz, Steven Woloshin

Abstract read
In one paragraph

Article in Proceedings of the National Academy of Sciences of the United States of America, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed.

  1. Trial
  2. Trial
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  4. Comparison of the Effects of a Pharmaceutical Industry Decision Guide and Decision Aids on Patient Choice to Intensify Therapy in Rheumatoid Arthritis.Medical decision making : an international journal of the Society for Medical Decision Making · 2017
    Trial
  5. Navigating the Prescription Drug Information System.Clinical pharmacology and therapeutics · 2026
    Review
  6. Applied behavioral and decision sciences in support of US FDA's drug regulatory mission.Proceedings of the National Academy of Sciences of the United States of America · 2026
    Article
  7. Review
  8. Toward Patient-Centered AI Fact Labels: Leveraging Extrinsic Trust Cues.DIS. Designing Interactive Systems (Conference) · 2025
    Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Obamacare: A bibliometric perspective.Frontiers in public health · 2022
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. The Evolving Field of Risk Communication.Risk analysis : an official publication of the Society for Risk Analysis · 2020
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Lisa M SchwartzVA Outcomes Group, Department of Veterans Affairs Medical Center, White River Junction, VT 05009, USA.
Steven Woloshin

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Communication about prescription drugs ought to be a paragon of public science communication. Unfortunately, it is not. Consumers see $4 billion of direct-to-consumer advertising annually, which typically fails to present data about how well drugs work. The professional label--the Food and Drug Administration's (FDA) mechanism to get physicians information needed for appropriate prescribing--may also fail to present benefit data. FDA labeling guidance, in fact, suggests that industry omit benefit data for new drugs in an existing class and for drugs approved on the basis of unfamiliar outcomes (such as depression rating scales). The medical literature is also problematic: there is selective reporting of favorable trials, favorable outcomes within trials, and "spinning" unfavorable results to maximize benefit and minimize harm. In contrast, publicly available FDA reviews always include the phase 3 trial data on benefit and harm, which are the basis of drug approval. However, these reviews are practically inaccessible: lengthy, poorly organized, and weakly summarized. To improve accessibility, we developed the Drug Facts Box: a one-page summary of benefit and harm data for each indication of a drug. A series of studies--including national randomized trials--demonstrates that most consumers understand the Drug Facts Box and that it improves decision-making. Despite calls from their own Risk Communication Advisory Committee and Congress (in the Affordable Care Act) to consider implementing boxes, the FDA announced it needs at least 3-5 y more to make a decision. Given its potential public health impact, physicians and the public should not have to wait that long for better drug information.

Indexed as

CommunicationDrug ApprovalDrug LabelingHumansInformation DisseminationOutcome Assessment, Health CarePatient Education as TopicPrescription DrugsSciencePrescription Drugsdata presentationevidence summariesphysician–patient communication

Identifiers

PMID23942130
PMCPMC3752172

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.