ArticleThe Milbank quarterly2014
Revisiting financial conflicts of interest in FDA advisory committees.
Article in The Milbank quarterly, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 61 citations in OpenAlex.
- Association between conflicts of interest and favourable recommendations in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews: systematic review.BMJ (Clinical research ed.) · 2020Pooled it
- Conflicts of interest in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews: associations with recommendations.The Cochrane database of systematic reviews · 2020Pooled it
- Prevalence of ties to industry-funded organizations among patient and consumer representatives on FDA advisory committees.Health affairs scholar · 2026Article
- How often do oncologists receive industry payments from competing companies?The oncologist · 2026Article
- Disclosure, transparency, and accountability: a qualitative survey of public sector pharmaceutical committee conflict of interest policies in the World Health Organization South-East Asia Region.Globalization and health · 2022Article
- Perceptions of Regulatory Decision-Making for New Drugs From the Viewpoints of the Manufacturers in South Korea.Frontiers in medicine · 2022Article
- Are Corporations Re-Defining Illness and Health? The Diabetes Epidemic, Goal Numbers, and Blockbuster Drugs.Journal of bioethical inquiry · 2021Review
- Characteristics and conflicts of interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee meetings.PloS one · 2021Article
- Article
- Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008-2015.The Milbank quarterly · 2019Article
- Financial conflicts of interest of clinicians making submissions to the pan-Canadian Oncology Drug Review: a descriptive study.BMJ open · 2019Article
- Debates about Conflict of Interest in Medicine: Deconstructing a Divided Discourse.Journal of bioethical inquiry · 2017Review
- Transparency ethics in practice: Revisiting financial conflicts of interest disclosure forms in clinical practice guidelines.PloS one · 2017Article
- Association Between Financial Conflicts of Interests and Supportive Opinions for Erectile Dysfunction Treatment.Journal of bioethical inquiry · 2016Article
- Frequency and Type of Conflicts of Interest in the Peer Review of Basic Biomedical Research Funding Applications: Self-Reporting Versus Manual Detection.Science and engineering ethics · 2016Article
- Ambiguous Capture: Collaborative Capitalism and the Meningitis Vaccine Project.Medical anthropologyArticle
- Article
Corrections and comments
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Authors and funding
1 author at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
contextThe Food and Drug Administration (FDA) Safety and Innovation Act has recently relaxed conflict-of-interest rules for FDA advisory committee members, but concerns remain about the influence of members' financial relationships on the FDA's drug approval process. Using a large newly available data set, this study carefully examined the relationship between the financial interests of FDA Center for Drug Evaluation and Research (CDER) advisory committee members and whether members voted in a way favorable to these interests.
methodsThe study used a data set of voting behavior and reported financial interests of 1,379 FDA advisory committee members who voted in CDER committee meetings that were convened during the 15-year period of 1997-2011. Data on 1,168 questions and 15,739 question-votes from 379 meetings were used in the analyses. Multivariable logit models were used to estimate the relationship between committee members' financial interests and their voting behavior.
findingsIndividuals with financial interests solely in the sponsoring firm were more likely to vote in favor of the sponsor than members with no financial ties (OR = 1.49, p = 0.03). Members with interests in both the sponsoring firm and its competitors were no more likely to vote in favor of the sponsor than those with no financial ties to any potentially affected firm (OR = 1.16, p = 0.48). Members who served on advisory boards solely for the sponsor were significantly more likely to vote in favor of the sponsor (OR = 4.97, p = 0.005).
conclusionsThere appears to be a pro-sponsor voting bias among advisory committee members who have exclusive financial relationships with the sponsoring firm but not among members who have nonexclusive financial relationships (ie, those with ties to both the sponsor and its competitors). These findings point to important heterogeneities in financial ties and suggest that policymakers will need to be nuanced in their management of financial relationships of FDA advisory committee members.
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What OpenQuestion holds
Registered trials
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.