Retracted papers originating from paper mills: cross sectional study.

OBJECTIVES: To describe retracted papers originating from paper mills, including their characteristics, visibility, and impact over time, and the journals in which they were published. DESIGN: Cross sectional study. SETTING: The Retraction Watch database was used for identification of retracted papers from paper mills, Web of Science was used for the total number of published papers, and data from Journal Citation Reports were collected to show characteristics of journals. PARTICIPANTS: All paper mill papers retracted from 1 January 2004 to 26 June 2022 were included in the study. Papers bearing an expression of concern were excluded. MAIN OUTCOME MEASURES: Descriptive statistics were used to characterise the sample and analyse the trend of retracted paper mill papers over time, and to analyse their impact and visibility by reference to the number of citations received. RESULTS: 1182 retracted paper mill papers were identified. The publication of the first paper mill paper was in 2004 and the first retraction was in 2016; by 2021, paper mill retractions accounted for 772 (21.8%) of the 3544 total retractions. Overall, retracted paper mill papers were mostly published in journals of the second highest Journal Citation Reports quartile for impact factor (n=529 (44.8%)) and listed four to six authors (n=602 (50.9%)). Of the 1182 papers, almost all listed authors of 1143 (96.8%) paper mill retractions came from Chinese institutions and 909 (76.9%) listed a hospital as a primary affiliation. 15 journals accounted for 812 (68.7%) of 1182 paper mill retractions, with one journal accounting for 166 (14.0%). Nearly all (n=1083, 93.8%) paper mill retractions had received at least one citation since publication, with a median of 11 (interquartile range 5-22) citations received. CONCLUSIONS: Papers retracted originating from paper mills are increasing in frequency, posing a problem for the research community. Retracted paper mill papers most commonly originated from China and were published in a small number of journals. Nevertheless, detected paper mill papers might be substantially different from those that are not detected. New mechanisms are needed to identify and avoid this relatively new type of misconduct.

A Critique of Helsinki Criteria for Using Lung Fiber Levels to Determine Causation in Mesothelioma Cases.

Asbestos is a known human carcinogen and the chief known cause of mesothelioma. In 1997, a group of experts developed the Helsinki Criteria, which established criteria for attribution of mesothelioma to asbestos. The criteria include two methods for causation attribution: 1) a history of significant occupational, domestic, or environmental exposure and/or 2) pathologic evidence of exposure to asbestos. In 2014, the Helsinki Criteria were updated, and these attribution criteria were not changed. However, since the Helsinki Criteria were first released in 1997, some pathologists, cell biologists, and others have claimed that a history of exposure cannot establish causation unless the lung asbestos fiber burden exceeds "the background range for the laboratory in question to attribute mesothelioma cases to exposure to asbestos." This practice ignores the impact on fiber burden of clearance/translocation over time, which in part is why the Helsinki Criteria concluded that a history of exposure to asbestos was independently sufficient to attribute causation to asbestos. After reviewing the Helsinki Criteria, we conclude that their methodology is fatally flawed because a quantitative assessment of a background lung tissue fiber level cannot be established. The flaws of the Helsinki Criteria are both technical and substantive. The 1995 paper that served as the scientific basis for establishing background levels used inconsistent methods to determine exposures in controls and cases. In addition, historic controls cannot be used to establish background fiber levels for current cases because ambient exposures to asbestos have decreased over time and control cases pre-date current cases by decades. The use of scanning electron microscope (SEM) compounded the non-compatibility problem; the applied SEM cannot distinguish talc from anthophyllite because it cannot perform selected area electron diffraction, which is a crucial identifier in ATEM for distinguishing the difference between serpentine asbestos, amphibole asbestos, and talc.

A Review of the Talc Industry's Influence on Federal Regulation and Scientific Standards for Asbestos in Talc.

The talc industry and Food and Drug Administration (FDA) have asserted that talc has been asbestos-free since 1976 when the industry created a voluntary specification for the asbestos content of cosmetic talc. However, recent evidence reveals that cosmetic talc is not and never was asbestos-free. This narrative review examines the talc industry's role in delaying and ultimately blocking federal regulation of cosmetic talc from the 1970s to today. We review primary source material, including corporate documents released in recent litigation and FDA documents released in response to Freedom of Information Act requests. Our results indicate that the talc industry exerted considerable influence over three key areas: regulatory proceedings at the FDA; testing methods and the manipulation of test results (including undisclosed results); and press coverage and the medical literature. The talc companies' actions and FDA indifference have had a lasting effect on consumer health, including the regulation of talc by other government agencies.

Serous Ovarian Cancer Caused by Exposure to Asbestos and Fibrous Talc in Cosmetic Talc Powders-A Case Series.

OBJECTIVE: Asbestos is a known cause of ovarian cancer. We report 10 cases of serous ovarian cancer among users of Johnson & Johnson (J&J) asbestos-containing "cosmetic" talc products. METHODS: We conducted an asbestos exposure assessment during talc application and analyzed surgical tissues and talc containers for asbestos and talc. RESULTS: Talc was found in all cases and tremolite and/or anthophyllite asbestos was found in 8/10 cases. The asbestos fibers found in the "cosmetic" talc containers matched those found in tissues. We estimated inhaled asbestos dose ranged from 0.38 to 5.18 fiber years. CONCLUSION: We provide evidence that the inhaled dose of asbestos/fibrous talc from "cosmetic" talc use causes ovarian cancer. The unique combination of the types of asbestiform minerals detected in cancerous tissue and "cosmetic" talc is a fingerprint for exposure to asbestos-containing talc.

The marketing of OxyContin®: A cautionary tale.

This paper provides a review of Purdue Pharma, LP's development and marketing of the long-acting oral narcotic OxyContin®. Within five years of the drug's launch, OxyContin® became the number-one prescribed Schedule II narcotic in the United States. This commercial success was in part the result of a marketing campaign that promoted questionably "distinctive" benefits and minimised the very real dangers of OxyContin®, which include abuse, addiction, overdose, and death. The marketing was based on scientifically invalid or unproven claims of safety and efficacy, inappropriate, off-label marketing, and inadequate warnings. When the FDA belatedly asked for changes to some of the marketing language, Purdue exploited these changes to further marketing objectives and misled healthcare practitioners. This case highlights questions of industry and governmental/regulatory accountability and responsibility for the production, marketing and sale of pharmaceutical products that increase risk while driving enhanced profits.

Commentary on "Assessment of Health Risk From Historical Use of Cosmetic Talcum Powder".

In response to recent litigation, Colgate Palmolive hired Exponent to determine if various samples of their cosmetic talc products contained asbestos. Anderson et al., Exponent employees, claim to report the findings of these analyses in their paper "Assessment of Health Risk from Historical Use of Cosmetic Talcum Powder." The microscopist who reviewed the samples found four anthophyllite fibers. One of the authors of Anderson et al., Patrick Sheehan, who is not a microscopist, directed the reviewing microscopist to alter the report and add the qualification that "…this classification was inconclusive due to the small number counted." Deviations from the referenced analytical methods, however, would account for the small number of fibers counted relative to the limit of detection. Anderson et al., reported that "no asbestos fibers were detected in any of the eighteen samples analyzed" based on the report's altered conclusions.

Use of Anti-Warnings to Falsely Reassure Downstream Users: An Asbestos Example.

Product warnings are theoretically designed to reduce injuries associated with occupational, environmental, or consumer product exposures. Unfortunately, in an effort to protect sales, some companies have produced media and information to falsely reassure their customers about the risks associated with their products. These tactics have been termed "anti-warnings." We reviewed corporate documents uncovered in litigation alongside other historical publications to ascertain the types of anti-warnings used by Union Carbide Corporation (UCC) regarding their asbestos products. Our review finds that UCC went to great lengths to confuse their customers and make their particular asbestos product-which contained short-fiber, chrysotile asbestos-look safe. We discuss three primary communications methods UCC used: industry-produced publications, sales force direct communication with customers, and public speeches. These examples provide further insight into how corporations encourage uncertainty about the risks associated with their products. Understanding anti-warning methods is critical for the implementation of future policies that protect consumer, worker, and environmental health.

The Production of Corporate Research to Manufacture Doubt About the Health Hazards of Products: An Overview of the Exponent Bakelite® Simulation Study.

Although corporate sponsorship of research does not necessarily lead to biased results, in some industries, it has resulted in the publication of inaccurate and misleading data. Some companies have hired scientific consulting firms to retrospectively calculate exposures to hazardous products during use that are no longer manufactured or sold. As an example, this paper reviews one such study-a litigation-generated study of Union Carbide Corporation's asbestos-containing product, Bakelite®. This analysis is based on previously secret documents, produced as a result of litigation. The study generated asbestos fiber exposure measurements which resulted in underestimates of actual exposures to create doubt about the hazards associated with manufacture and manipulation of Bakelite®.

Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system.

In 2001, DePuy, a wholly-owned subsidiary of Johnson & Johnson (J&J/DePuy), initiated a seeding study called the "Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty" (PIN Study). J&J/DePuy designed this study to develop new business opportunities during the launch of their Pinnacle Hip System (PHS) and generate survivorship data for marketing. This article, the first review of a seeding trial for a medical device, examines internal company documents relating to the PIN Study; the analysis herein focuses on the integrity of J&J/DePuy's research practices in conception, implementation, and analysis. J&J/DePuy violated the study protocol and manipulated data; consented participants in violation of standards protecting human subjects; and did not secure Institutional Review Board approval for all study sites. J&J/DePuy used PIN Study results as the "fundamental selling point" for the PHS. Medical device seeding trials are distinct from previously-documented pharmaceutical seeding trials because companies can profit directly from device sales and because these studies may be the first clinical evaluation of the device (as was the case for the PIN Study). Seeding trials are malleable marketing projects, not rigorous scientific studies. Regulatory bodies, physicians, and others should be vigilant for persuasive marketing accounts disguised as science.