Corporate corruption of science-Another asbestos example.

BACKGROUND: Kelsh et al. [2007]: Occup Med (Lond) 57:581-589 published a paper reanalyzing one of the few data sources publicly available on mesothelioma amongst brake workers, the Australian Mesothelioma Surveillance Registry (AMSR). This reanalysis was commissioned by lawyers representing the automobile manufacturing companies and did not align with an independent analysis published by Leigh and Driscoll [2003]: Occup Environ Health 9:206-217. METHODS: We sought to reevaluate the AMSR data ourselves to understand how the company-sponsored research categorized the data. RESULTS: In our re-analysis of the 78 brake-related folios in the AMSR, we determined that 57 were employed brake mechanics, 35 were employed brake mechanics with no other asbestos exposure besides brake work or repair, and 41 of these cases had no other asbestos exposure besides brake work or repair. Our classifications differed significantly from Kelsh et al. CONCLUSIONS: We discuss how Kelsh et al. methodically reduced the relevant cases by following overly stringent criteria for inclusion. Am. J. Ind. Med. 60:152-162, 2017. © 2017 Wiley Periodicals, Inc.

Short fiber tremolite free chrysotile mesothelioma cohort revealed.

In 1995, Dell and Teta published a cohort mortality study of asbestos molding compound workers at a Union Carbide Corporation (UCC) plastics manufacturing plant in Bound Brook, New Jersey. They reported that the factory workers were exposed to "asbestos (mostly chrysotile)," implying that the asbestos used at the Bound Brook plant occasionally contained amphiboles. However, UCC statements and testimony from recent litigation indicate that the Bound Brook plant exclusively used short fiber chrysotile asbestos. These recent documents also point to lower exposures than those reported by Dell and Teta. This chrysotile-only cohort should be included in analyses of chrysotile potency.

Dust diseases and the legacy of corporate manipulation of science and law.

BACKGROUND: The dust diseases silicosis and asbestosis were the first occupational diseases to have widespread impact on workers. Knowledge that asbestos and silica were hazardous to health became public several decades after the industry knew of the health concerns. This delay was largely influenced by the interests of Metropolitan Life Insurance Company (MetLife) and other asbestos mining and product manufacturing companies. OBJECTIVES: To understand the ongoing corporate influence on the science and politics of asbestos and silica exposure, including litigation defense strategies related to historical manipulation of science. METHODS: We examined previously secret corporate documents, depositions and trial testimony produced in litigation; as well as published literature. RESULTS: Our analysis indicates that companies that used and produced asbestos have continued and intensified their efforts to alter the asbestos-cancer literature and utilize dust-exposure standards to avoid liability and regulation. Organizations of asbestos product manufacturers delayed the reduction of permissible asbestos exposures by covering up the link between asbestos and cancer. Once the decline of the asbestos industry in the US became inevitable, the companies and their lawyers designed the state of the art (SOA) defense to protect themselves in litigation and to maintain sales to developing countries. CONCLUSIONS: Asbestos product companies would like the public to believe that there was a legitimate debate surrounding the dangers of asbestos during the twentieth century, particularly regarding the link to cancer, which delayed adequate regulation. The asbestos-cancer link was not a legitimate contestation of science; rather the companies directly manipulated the scientific literature. There is evidence that industry manipulation of scientific literature remains a continuing problem today, resulting in inadequate regulation and compensation and perpetuating otherwise preventable worker and consumer injuries and deaths.

MetLife and its corporate allies: dust diseases and the manipulation of science.

BACKGROUND: The dust diseases silicosis and asbestosis were the first occupational diseases to have widespread impact on workers. Knowledge that asbestos and silica were hazardous to health became public long after the industry knew of the health concerns. This delay was largely influenced by the interests of Metropolitan Life Insurance Company (MetLife). OBJECTIVES: To understand how MetLife influenced the science and politics of asbestos and silica exposure in the first half of the twentieth century. METHODS: We examined previously secret corporate documents produced in litigation, deposition, and trial testimony, as well as published scholarship. RESULTS: MetLife established itself as an authority in public and industrial health in the early part of the twentieth century, gaining the trust of the public and government. They were able to use this trust and authority to avoid financial loss, including the firing of sick workers, and avoid legal liability by organizing a network of experts to testify on their behalf in silica- and asbestos-related damage suits. They further manipulated the results of scientific findings from major research institutions, delaying important knowledge about the asbestos-cancer relationship. They also influenced law and public policy through writing and implementing worker compensation laws in numerous states and concocting an arbitrary "protective" standard to monitor asbestos exposure. This standard was known by MetLife to not protect against disease. CONCLUSIONS: The actions of MetLife and its allies had real human and scientific consequences and an effect on the industry lasting until now.

Bronchiolitis obliterans and consumer exposure to butter-flavored microwave popcorn: a case series.

Respiratory exposure to diacetyl and diacetyl-containing flavorings used in butter-flavored microwave popcorn (BFMP) causes lung disease, including bronchiolitis obliterans (BO), in flavorings and popcorn manufacturing workers. However, there are no published reports of lung disease among BFMP consumers. We present a case series of three BFMP consumers with biopsy-confirmed BO. We review data relating to consumer exposures, estimate case exposures, and compare them to diacetyl-containing flavoring-exposed manufacturing workers with lung disease. These consumer cases' exposure levels are comparable to those that caused disease in workers. We were unable to identify any other exposures or diseases known or suspected to cause BO in these cases. BFMP poses a significant respiratory risk to consumers. Some manufacturers have substituted diacetyl with other alpha-diketones that are likely to pose a similar risk. Simple consumer practices such as cooling the popcorn bag would eliminate the risk of severe lung disease.

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 case of occupational peritoneal mesothelioma from exposure to tremolite-free chrysotile in Quebec, Canada: A black swan case.

BACKGROUND: Tremolite contamination has been proposed as the cause of mesothelioma in workers exposed to commercial chrysotile. The asbestos industry and scientists it has sponsored, for example, have argued that commercial chrysotile does not cause peritoneal mesothelioma. METHOD: Case report of peritoneal mesothelioma in a mill worker from a tremolite free Canadian mine. RESULTS: Reports from pathology and occupational health and safety panels conclude that this mill worker developed work-related peritoneal mesothelioma. CONCLUSION: Chrysotile without tremolite can cause peritoneal mesothelioma.

A proposal for a safe exposure level for diacetyl.

Diacetyl is a naturally occurring compound that has been used in concentrated form as a food additive, particularly in butter flavorings. Inhalation of diacetyl and butter flavoring fumes has caused a variety of respiratory diseases in workers and consumers including bronchiolitis obliterans (BO), a relatively rare, severe, and irreversible lung disease. A safe level of exposure to diacetyl has not been established. We review the literature on diacetyl and flavoring toxicity and critique a recent proposal for an occupational exposure limit (OEL) of 0.2 ppm for diacetyl. We present unpublished data and novel analyses in support of our proposal for a safe level of exposure. Our findings indicate that a safe level of exposure exists around or below a time-weighted average of 1 ppb for an eight-hour workday. The levels of exposure we found to be unsafe include ranges that popcorn consumers may potentially be exposed to, indicating a risk of severe lung disease (including BO) for some consumers.

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.