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Cigarette company trade secrets are not secret: an analysis of reverse engineering reports in internal tobacco industry documents released as a result of litigation.

ABSTRACT: Use previously secret tobacco industry documents to assess tobacco companies' routine claims of trade secret protection for information on cigarette ingredients, additives and construction made to regulatory agencies, as well as the companies' refusal to publicly disclose this information.We analysed previously secret tobacco industry documents available at (http://legacy.library.ucsf.edu) to identify 100 examples of seven major tobacco companies' reverse engineering of their competitors' brands between 1937 and 2001.These reverse engineering reports contain detailed data for 142 different measurements for at least two companies, including physical parameters of the cigarettes, tobacco types, humectants, additives, flavourings, and smoke constituents of competitors' cigarettes. These 100 documents were distributed to 564 employees, including top managers in domestic and foreign offices across multiple departments, including executive leadership, research and design, product development, marketing and legal. These documents reported new competitors' products, measured ingredient changes over time, and informed companies' decisions regarding ingredients in their own products.Because cigarette companies routinely analyse their competitors' cigarettes in great detail, this information is neither secret nor commercially valuable and, thus, does not meet the legal definition of a 'trade secret.' This information is only being kept 'secret' from the people consuming cigarettes and the scientific community. Public agencies should release this detailed information because it would provide valuable information about how ingredients affect addictiveness and toxicity, and would help the public health community and consumers better understand the impact of cigarette design on human health.

SUBMITTER: Velicer C

PROVIDER: S-EPMC4263698 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Cigarette company trade secrets are not secret: an analysis of reverse engineering reports in internal tobacco industry documents released as a result of litigation.

Velicer Clayton C Lempert Lauren K LK Glantz Stanton S

Tobacco control 20140611 5

<h4>Objectives</h4>Use previously secret tobacco industry documents to assess tobacco companies' routine claims of trade secret protection for information on cigarette ingredients, additives and construction made to regulatory agencies, as well as the companies' refusal to publicly disclose this information.<h4>Methods</h4>We analysed previously secret tobacco industry documents available at (http://legacy.library.ucsf.edu) to identify 100 examples of seven major tobacco companies' reverse engin ...[more]

PMID: 24920577

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Project description:In 2009, the promulgation of US Food and Drug Administration (FDA) tobacco regulation focused attention on cigarette flavor additives. The tobacco industry had prepared for this eventuality by initiating a research program focusing on additive toxicity. The objective of this study was to analyze Philip Morris' Project MIX as a case study of tobacco industry scientific research being positioned strategically to prevent anticipated tobacco control regulations.We analyzed previously secret tobacco industry documents to identify internal strategies for research on cigarette additives and reanalyzed tobacco industry peer-reviewed published results of this research. We focused on the key group of studies conducted by Phillip Morris in a coordinated effort known as "Project MIX." Documents showed that Project MIX subsumed the study of various combinations of 333 cigarette additives. In addition to multiple internal reports, this work also led to four peer-reviewed publications (published in 2001). These papers concluded that there was no evidence of substantial toxicity attributable to the cigarette additives studied. Internal documents revealed post hoc changes in analytical protocols after initial statistical findings indicated an additive-associated increase in cigarette toxicity as well as increased total particulate matter (TPM) concentrations in additive-modified cigarette smoke. By expressing the data adjusted by TPM concentration, the published papers obscured this underlying toxicity and particulate increase. The animal toxicology results were based on a small number of rats in each experiment, raising the possibility that the failure to detect statistically significant changes in the end points was due to underpowering the experiments rather than lack of a real effect.The case study of Project MIX shows tobacco industry scientific research on the use of cigarette additives cannot be taken at face value. The results demonstrate that toxins in cigarette smoke increase substantially when additives are put in cigarettes, including the level of TPM. In particular, regulatory authorities, including the FDA and similar agencies elsewhere, could use the Project MIX data to eliminate the use of these 333 additives (including menthol) from cigarettes.

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Project description:BACKGROUND: Previous studies have documented strategies to promote off-label use of drugs using journal publications and other means. Few studies have presented internal company communications that discussed financial reasons for manipulating the scholarly record related to off-label indications. The objective of this study was to build on previous studies to illustrate implementation of a publication strategy by the drug manufacturer for four off-label uses of gabapentin (Neurontin, Pfizer, Inc.): migraine prophylaxis, treatment of bipolar disorders, neuropathic pain, and nociceptive pain. METHODS: We included in this study internal company documents, email correspondence, memoranda, study protocols and reports that were made publicly available in 2008 as part of litigation brought by consumers and health insurers against Pfizer for fraudulent sales practices in its marketing of gabapentin (see http://pacer.mad.uscourts.gov/dc/cgi-bin/recentops.pl?filename=saris/pdf/ucl%20opinion.pdf for the Court's findings).We reviewed documents pertaining to 20 clinical trials, 12 of which were published. We categorized our observations related to reporting biases and linked them with topics covered in internal documents, that is, deciding what should and should not be published and how to spin the study findings (re-framing study results to explain away unfavorable findings or to emphasize favorable findings); and where and when findings should be published and by whom. RESULTS: We present extracts from internal company marketing assessments recommending that Pfizer and Parke-Davis (Pfizer acquired Parke-Davis in 2000) adopt a publication strategy to conduct trials and disseminate trial findings for unapproved uses rather than an indication strategy to obtain regulatory approval. We show internal company email correspondence and documents revealing how publication content was influenced and spin was applied; how the company selected where trial findings would be presented or published; how publication of study results was delayed; and the role of ghost authorship. CONCLUSIONS: Taken together, the extracts we present from internal company documents illustrate implementation of a strategy at odds with unbiased study conduct and dissemination. Our findings suggest that Pfizer and Parke-Davis's publication strategy had the potential to distort the scientific literature, and thus misinform healthcare decision-makers.

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Cigarette company trade secrets are not secret: an analysis of reverse engineering reports in internal tobacco industry documents released as a result of litigation.

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Cigarette company trade secrets are not secret: an analysis of reverse engineering reports in internal tobacco industry documents released as a result of litigation.

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