In October UK patients who had cardiovascular events while taking rofecoxib lost the right to fight Merck in the US for compensation. But researchers and journals can still benefit from this case if they learn from the mistakes, write Harlan Krumholz and colleagues

UTHORSHIP IN BIOMEDICALpublication provides recognition while establishing accountability and responsibility. Guest authorship has been defined as the designation of an individual who does not meet authorship criteria as an author. 1,2 It was identified in 16% of research articles, 26% of review articles, and 21% of editorials in a survey of 6 peer-reviewed medical journals, 3 in addition to 41% of Cochrane reviews. 4 Ghostwriting has been defined as the failure to designate an individual (as an author) who has made a substantial contribution to the research or writing of a manuscript. 1 Ghostwriting was demonstrated in 13% of research articles, 10% of review articles, 6% of editorials, and 11% of Cochrane reviews 3,4 ; other research has found similar rates. 5 Two studies have characterized the practices of guest authorship and ghostwriting using industry documents, one examining practices related to gabapentin by Pfizer Inc and Parke-Davis, Division of Warner-Lambert Company, 6 the other sertraline by Pfizer Inc. 7 However, these studies were focused on how the research and publication strat-See also pp 1813 and 1833.

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.

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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 v. Pfizer and Franklin v. Warner-Lambert, the majority of 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. Results Documents demonstrated that STEPS was a seeding trial posing as a legitimate scientific study. Documents consistently described the trial itself, not trial results, to be a marketing tactic in the company’s marketing plans. Documents demonstrated that several external sources questioned the validity of the study before execution, and that data quality during the study was often compromised. Furthermore, documents described company analyses examining the impact of participating as a STEPS investigator on rates and dosages of gabapentin prescribing, finding a positive association. None of these findings were reported in two published papers. Conclusions The STEPS trial was a seeding trial, used to promote gabapentin and increase prescribing among investigators, and marketing was extensively involved in its planning and implementation.

Corporations and industries use various tactics to obscure the fact that their products are dangerous or deadly. Their aim is to secure the least restrictive possible regulatory environment and avert legal liability for deaths or injuries in order to maximize profit. They work with attorneys and public relations professionals, using scientists, science advisory boards; front groups, industry organizations, think tanks, and the media to influence scientific and popular opinion of the risks of their products or processes. The strategy, which depends on corrupt science, profits corporations at the expense of public health. Public health professionals can learn from this strategy how to effectively build scientific and public opinion that prioritizes both good science and the public health.

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.