Tobacco Company Misrepresented Danger from Cigarettes, Study Finds.

Tobacco Company Misrepresented Danger from Cigarettes, Study Finds

Toxicity Levels Obscured, Increasing Risks of Heart Disease, Cancer

A new UCSF analysis of tobacco industry documents shows that Philip Morris USA manipulated data on the effects of additives in cigarettes, including menthol, obscuring actual toxicity levels and increasing the risk of heart, cancer and other diseases for smokers.

Tobacco industry information can’t be taken at face value, the researchers conclude. They say their work provides evidence that hundreds of additives, including menthol, should be eliminated from cigarettes on public health grounds.

The article is published in PLoS Medicine.

In the new, independent study, the scientists reassessed data from Philip Morris’ “Project MIX,” which detailed chemical analyses of smoke and animal toxicology studies of 333 cigarette additives. Philip Morris, the nation’s largest tobacco company, published its findings in 2002.

By investigating the origins and design of Project MIX, the UCSF researchers conducted their own inquiry into the Philip Morris results. They stressed that many of the toxins in cigarette smoke substantially increased after additives were added to cigarettes.

They also found, after obtaining evidence that additives increased toxicity, that tobacco scientists adjusted the protocol for presenting their results in a way that obscured these increases.

Senior author Stanton A. Glantz, PhD,
UCSF professor of medicine and director of the Center for Tobacco Control Research and Education at UCSF.

“We discovered these post-hoc changes in analytical protocols after the industry scientists found that the additives increased cigarette toxicity by increasing the number of fine particles in the cigarette smoke that cause heart and other diseases,” said senior author Stanton A. Glantz, PhD, UCSF professor of medicine and director of the Center for Tobacco Control Research and Education at UCSF.

“When we conducted our own analysis by studying additives per cigarette — following Philip Morris’ original protocol — we found that 15 carcinogenic chemicals increased by 20 percent or more,” he said.

Additionally, in the independent study, the researchers discovered the reason behind Philip Morris’ failure to identify many toxic effects in animal studies: its studies were too small.

“The experiment was too small in terms of the number of rats analyzed to statistically detect important changes in biological effects,” Glantz said. “Philip Morris underpowered its own studies.”

The results of “Project MIX” were first published as four papers in a 2002 edition of Food and Chemical Toxicology, a journal whose editor and many members of its editorial board had financial ties to the tobacco industry. While Philip Morris was trying to get the papers published, the company scientist who led Project Mix sent an email to a colleague  describing the peer review process as an inside job.

In the new study, the researchers used documents made public as a result of litigation against the tobacco industry. The documents are available to the public through UCSF’s Legacy Tobacco Documents Library.

Co-authors of the study include Marcia Wertz, RN, PhD, of UCSF’s Department of Social and Behavioral Sciences.

The study was supported by the National Cancer Institute.

UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.

###

A video describing the paper is available:
…
The Toxic Effects of Cigarette Additives. Philip Morris’ Project Mix Reconsidered: An Analysis of Documents Released through Litigation

…

This video describes the peer reviewed paper, 

Wertz MS, Kyriss T, Paranjape S, Glantz SA (2011) The Toxic Effects of Cigarette Additives. Philip Morris’ Project Mix Reconsidered: An Analysis of Documents Released through Litigation. PLoS Med 8(12): e1001145. doi:10.1371/journal.pmed.1001145

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

###

> About University of California, San Francisco (UCSF).

The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only UC campus in the 10-campus system dedicated exclusively to the health sciences.

More about University of California, San Francisco (UCSF).

More about University of California, San Francisco (UCSF). Information.

###

*  The above story is adapted from materials provided by University of California, San Francisco (UCSF)

________________________________________________________________