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December 20th, 2011:

The Toxic Effects of Cigarette Additives. Philip Morris’ Project Mix Reconsidered: An Analysis of Documents Released through Litigation

Dec 20th, 2011
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Abstract
Background: 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.
Methods and Findings: 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.
Conclusion: 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.

AbstractBackground: In 2009, the promulgation of US Food and Drug Administration (FDA) tobacco regulation focused attention oncigarette flavor additives. The tobacco industry had prepared for this eventuality by initiating a research program focusingon additive toxicity. The objective of this study was to analyze Philip Morris’ Project MIX as a case study of tobacco industryscientific research being positioned strategically to prevent anticipated tobacco control regulations.Methods and Findings: We analyzed previously secret tobacco industry documents to identify internal strategies forresearch on cigarette additives and reanalyzed tobacco industry peer-reviewed published results of this research. Wefocused on the key group of studies conducted by Phillip Morris in a coordinated effort known as ‘‘Project MIX.’’ Documentsshowed that Project MIX subsumed the study of various combinations of 333 cigarette additives. In addition to multipleinternal reports, this work also led to four peer-reviewed publications (published in 2001). These papers concluded thatthere was no evidence of substantial toxicity attributable to the cigarette additives studied. Internal documents revealedpost hoc changes in analytical protocols after initial statistical findings indicated an additive-associated increase in cigarettetoxicity as well as increased total particulate matter (TPM) concentrations in additive-modified cigarette smoke. Byexpressing the data adjusted by TPM concentration, the published papers obscured this underlying toxicity and particulateincrease. The animal toxicology results were based on a small number of rats in each experiment, raising the possibility thatthe failure to detect statistically significant changes in the end points was due to underpowering the experiments ratherthan lack of a real effect.Conclusion: The case study of Project MIX shows tobacco industry scientific research on the use of cigarette additivescannot be taken at face value. The results demonstrate that toxins in cigarette smoke increase substantially when additivesare put in cigarettes, including the level of TPM. In particular, regulatory authorities, including the FDA and similar agencieselsewhere, could use the Project MIX data to eliminate the use of these 333 additives (including menthol) from cigarettes.

Download full PDF : journal.pmed.1001145[1]