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 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 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 ADVANTAGE seeding trial: a review of internal documents.

BACKGROUND: Seeding trials, clinical studies conducted by pharmaceutical companies that are designed to seem as if they answer a scientific question but primarily fulfill marketing objectives, have not been described in detail. PURPOSE: To describe a known seeding trial, ADVANTAGE (Assessment of Differences between Vioxx and Naproxen To Ascertain Gastrointestinal Tolerability and Effectiveness), through documents of the trial sponsor, Merck & Co. (Whitehouse Station, New Jersey). DATA SOURCES: Merck internal and external correspondence, reports, and presentations elicited to inform legal proceedings of Cona v Merck and Co., Inc., and McDarby v Merck and Co., Inc. The documents were created between 1998 and 2006. DATA EXTRACTION: An iterative case-study process of review, discussion, and re-review of documents to identify themes relevant to the design and conduct of ADVANTAGE. To supplement the case-study review, the authors did a systematic review of the literature to identify published manuscripts focused on seeding trials and their conduct. DATA SYNTHESIS: Review of the documents revealed 3 key themes: The trial was designed by Merck's marketing division to fulfill a marketing objective; Merck's marketing division handled both the scientific and the marketing data, including collection, analysis, and dissemination; and Merck hid the marketing nature of the trial from participants, physician investigators, and institutional review board members. Although the systematic review of the literature identified 6 articles that focused on the practice of seeding trials, none provided documentary evidence of their existence or conduct. LIMITATIONS: The legal documents in these cases provide useful, but limited, information about the practices of the pharmaceutical industry. This description of 1 company's actions is incomplete and may have limited generalizability. CONCLUSION: Documentary evidence shows that ADVANTAGE is an example of marketing framed as science. The documents indicate that ADVANTAGE was a seeding trial developed by Merck's marketing division to promote prescription of Vioxx (rofecoxib) when it became available on the market in 1999.

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.

Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation.

CONTEXT: Authorship in biomedical publication provides recognition and establishes accountability and responsibility. Recent litigation related to rofecoxib provided a unique opportunity to examine guest authorship and ghostwriting, practices that have been suspected in biomedical publication but for which there is little documentation. OBJECTIVE: To characterize different types and the extent of guest authorship and ghostwriting in 1 case study. DATA SOURCES: Court documents originally obtained during litigation related to rofecoxib against Merck & Co Inc. Documents were created predominantly between 1996 and 2004. In addition, publicly available articles related to rofecoxib identified via MEDLINE. DATA EXTRACTION: All documents were reviewed by one author, with selected review by coauthors, using an iterative process of review, discussion, and rereview of documents to identify information related to guest authorship or ghostwriting. DATA SYNTHESIS: Approximately 250 documents were relevant to our review. For the publication of clinical trials, documents were found describing Merck employees working either independently or in collaboration with medical publishing companies to prepare manuscripts and subsequently recruiting external, academically affiliated investigators to be authors. Recruited authors were frequently placed in the first and second positions of the authorship list. For the publication of scientific review papers, documents were found describing Merck marketing employees developing plans for manuscripts, contracting with medical publishing companies to ghostwrite manuscripts, and recruiting external, academically affiliated investigators to be authors. Recruited authors were commonly the sole author on the manuscript and offered honoraria for their participation. Among 96 relevant published articles, we found that 92% (22 of 24) of clinical trial articles published a disclosure of Merck's financial support, but only 50% (36 of 72) of review articles published either a disclosure of Merck sponsorship or a disclosure of whether the author had received any financial compensation from the company. CONCLUSIONS: This case-study review of industry documents demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support.

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.

American College of Occupational and Environmental Medicine (ACOEM): a professional association in service to industry.

The American College of Occupational and Environmental Medicine (ACOEM) is a professional association that represents the interests of its company-employed physician members. Fifty years ago the ACOEM began to assert itself in the legislative arena as an advocate of limited regulation and enforcement of occupational health and safety standards and laws, and environmental protection. Today the ACOEM provides a legitimizing professional association for company doctors, and continues to provide a vehicle to advance the agendas of their corporate sponsors. Company doctors in ACOEM recently blocked attempts to have the organization take a stand on global warming. Company doctors employed by the petrochemical industry even blocked the ACOEM from taking a position on particulate air pollution. Industry money and influence pervade every aspect of occupational and environmental medicine. The controlling influence of industry over the ACOEM physicians should cease. The conflict of interests inherent in the practice of occupational and environmental medicine is not resolved by the ineffectual efforts of the ACOEM to establish a pretentious code of conduct. The conflicted interests within the ACOEM have become too deeply embedded to be resolved by merely a self-governing code of conduct. The specialty practice of occupational and environmental medicine has the opportunity and obligation to join the public health movement. If it does, the ACOEM will have no further purpose as it exists, and specialists in occupational and environmental medicine will meet with and be represented by public health associations. This paper chronicles the history of occupational medicine and industry physicians as influenced and even controlled by corporate leaders.

Suppression bias at the Journal of Occupational and Environmental Medicine.

When the Journal of Occupational and Environmental Medicine rejected an article on corporate suppression of science on the grounds that the topic "was not a high priority" for journal readers, the author bought advertising space in JOEM to present his findings. The JOEM editor regretted he had not seen the ad to prevent its publication, and subsequently allowed the corporate-sponsored authors of a criticized study to respond to the advertisement. The editor then refused to allow the ad's author to respond in turn, suppressing scientific information with the apparent intent of protecting the interests and profits of the corporate sponsor. A reputable journal has a responsibility to eschew corporate interests and work to uncover science hidden by interests that do not prioritize the pursuit of truth. JOEM needs to re-examine its priorities.

Over a barrel: corporate corruption of science and its effects on workers and the environment.

Although occupational and environmental diseases are often viewed as isolated and unique failures of science, the government, or industry to protect the best interest of the public, they are in fact an outcome of a pervasive system of corporate priority setting, decision making, and influence. This system produces disease because political, economic, regulatory and ideological norms prioritize values of wealth and profit over human health and environmental well-being. Science is a key part of this system; there is a substantial tradition of manipulation of evidence, data, and analysis, ultimately designed to maintain favorable conditions for industry at both material and ideological levels. This issue offers examples of how corporations influence science, shows the effects that influence has on environmental and occupational health, and provides evidence of a systemic problem.

Abuse of epidemiology: automobile manufacturers manufacture a defense to asbestos liability.

Much of the "debate" about the relationship between asbestos exposure from automobile brake work and asbestos-induced cancer has been fueled by studies that have been funded by corporations with billions at stake in tort litigation. The authors explore how asbestos-lined brake manufacturers have corrupted medical literature to escape liability, analyzing studies funded by these companies to enable them to claim that work with asbestos brake linings never causes mesothelioma. They reveal how the companies have redefined scientific criteria for the determination of cause-effect relationships and manipulated scientific data to give the impression of an absence of effect. But the absence of evidence is not evidence of the absence of an effect.