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.

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.

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.

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.

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.

Withdrawn: The production of corporate research to manufacture doubt about the health hazards of products: an overview of the Exponent Bakelite™ simulation study.

Withdrawal statement Egilman DS. The production of corporate research to manufacture doubt about the health hazards of products: an overview of the Exponent Bakelite™ simulation study. International Journal of Occupational and Environmental Health.

Ethics, morality, and conflicting interests: how questionable professional integrity in some scientists supports global corporate influence in public health.

Clinical and public health research, education, and medical practice are vulnerable to influence by corporate interests driven by the for-profit motive. Developments over the last 10 years have shown that transparency and self-reporting of corporate ties do not always mitigate bias. In this article, we provide examples of how sound scientific reasoning and evidence-gathering are undermined through compromised scientific enquiry resulting in misleading science, decision-making, and policy intervention.

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).

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.

Deconstructing a state-of-the-art review of the asbestos brake industry.

State of the art is a legal concept that describes what was known as knowable by experts including manufacturer's state of knowledge about the potential hazards of their product(s) at a point in time. In 2004, Paustenbach et al. published a state-of-the-art review that describes the development of knowledge about asbestos hazards to brake mechanics performing asbestos brake installation and maintenance.

Study of neurontin: titrate to effect, profile of safety (STEPS) trial: a narrative account of a gabapentin seeding trial.

Background: Seeding trials, clinical studies conducted by pharmaceutical companies for marketing purposes, have rarely been described in detail.

Methods: We examined all documents relating to the clinical trial Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) produced during the Neurontin marketing, sales practices, and product liability litigation, including company internal and external correspondence, reports, and presentations, as well as depositions elicited in legal proceedings of Harden Manufacturing vs Pfizer and Franklin vs Warner-Lambert, most which were created between 1990 and 2009. Using a systematic search strategy, we identified and reviewed all documents related to the STEPS trial in order to identify key themes related to the trial's conduct and determine the extent of marketing involvement in its planning and implementation.

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.

Pooled analysis of rofecoxib placebo-controlled clinical trial data: lessons for postmarket pharmaceutical safety surveillance.

Background: In September 2004, rofecoxib was voluntarily withdrawn from the worldwide market. Our objective was to determine whether and when analysis of published and unpublished placebo-controlled trials could have revealed cardiovascular risk associated with rofecoxib before its withdrawal as an example to inform future postmarket pharmaceutical safety surveillance efforts.

Methods: We conducted a cumulative subject-level pooled analysis of data from all randomized, placebo-controlled trials of rofecoxib conducted by the manufacturer before September 2004.

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).

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.

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.