ArticlePLoS medicine2013
Tobacco company efforts to influence the Food and Drug Administration-commissioned Institute of Medicine report clearing the smoke: an analysis of documents released through litigation.
Article in PLoS medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled 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.
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
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.
- Financial Conflicts of Interest and Stance on Tobacco Harm Reduction: A Systematic Review.American journal of public health · 2019Pooled it
- A systematic review on risk factors and reasons for e-cigarette use in adolescents.Tobacco induced diseases · 2025Review
- Perceived Truthfulness of Reduced Lung Cancer Risk Advertising Claims Influences Consumers' Intention to try and to Purchase Snus.Tobacco use insights · 2023Article
- FDA's reduced exposure marketing order for IQOS: why it is not a reliable global model.Tobacco control · 2022Article
- Does a human rights-based approach to harm reduction support commercialized harm reduction? Brief research.Frontiers in public health · 2022Review
- Heated tobacco products: another tobacco industry global strategy to slow progress in tobacco control.Tobacco control · 2018Article
- Public versus internal conceptions of addiction: An analysis of internal Philip Morris documents.PLoS medicine · 2018Article
- Evaluation of modified risk claim advertising formats for Camel Snus.Health education journal · 2017Article
- Food for thought? Potential conflicts of interest in academic experts advising government and charities on dietary policies.BMC public health · 2016Article
- Initiation and continuation of smoking in iran: a qualitative content analysis.International journal of community based nursing and midwifery · 2014Article
- The debate on regulating menthol cigarettes: closing a dangerous loophole vs freedom of choice.American journal of public health · 2014Article
- Irreconcilable conflict: the tobacco industry and the public health challenge of tobacco use.PLoS medicine · 2013Article
Corrections and comments
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Authors and funding
3 authors at 2 institutions in 2 countries.
Funding
Abstract
backgroundSpurred by the creation of potential modified risk tobacco products, the US Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to assess the science base for tobacco "harm reduction," leading to the 2001 IOM report Clearing the Smoke. The objective of this study was to determine how the tobacco industry organized to try to influence the IOM committee that prepared the report. METHODS AND
findingsWe analyzed previously secret tobacco industry documents in the University of California, San Francisco Legacy Tobacco Documents Library, and IOM public access files. (A limitation of this method includes the fact that the tobacco companies have withheld some possibly relevant documents.) Tobacco companies considered the IOM report to have high-stakes regulatory implications. They developed and implemented strategies with consulting and legal firms to access the IOM proceedings. When the IOM study staff invited the companies to provide information on exposure and disease markers, clinical trial design for safety and efficacy, and implications for initiation and cessation, tobacco company lawyers, consultants, and in-house regulatory staff shaped presentations from company scientists. Although the available evidence does not permit drawing cause-and-effect conclusions, and the IOM may have come to the same conclusions without the influence of the tobacco industry, the companies were pleased with the final report, particularly the recommendations for a tiered claims system (with separate tiers for exposure and risk, which they believed would ease the process of qualifying for a claim) and license to sell products comparable to existing conventional cigarettes ("substantial equivalence") without prior regulatory approval. Some principles from the IOM report, including elements of the substantial equivalence recommendation, appear in the 2009 Family Smoking Prevention and Tobacco Control Act.
conclusionsTobacco companies strategically interacted with the IOM to win several favored scientific and regulatory recommendations.
Indexed as
Identifiers
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.