Stanton Glantz and colleagues analyzed previously secret tobacco industry documents and peer-reviewed published results of Philip Morris' Project MIX about research on cigarette additives, and show that this research on the use of cigarette additives cannot be taken at face value

A Mutti

A-L Fisher

B Serdar

BA Fetterman

BC Lee

C Blake

C Henry

CA Pope 3rd

CJ Blake

CL Ellis

CL Gaworski

D Bachmayer

D Garne

D Kim

D Kuhn

DJ Slebos

E (Univ Mainz) Muscholl

E Roemer

E Yano

EK Tong

EL Carmines

G Nixon

G Smith

H Gugel

H Wakeham

J Allison

J Borzelleca

J Doull

J Fowles

J McCann

JD Heck

JE Lowe

JR Sobus

K Neilsen

K Rustemeier

Kelley Lee

KT Bogen

L Bero

L Rudge

M Al Rashidi

M van der Toorn

Marcia S. Wertz

N Benowitz

N Winston

O Moennikes

O Pelkonen

PA Diethelm

PA McDaniel

Philip Morris

PM Vanscheeuwijck

R Baker

R Barbara

R Lemus

R Solana

R Thornton

RA Blevins Jr

RA Walk

RD Brook

RE Malone

RJ Reynolds

RL Barnes

RP Solana

RR Baker

S Ejaz

S Parodi

S Saunders

SA Glantz

SJ Anderson

Stanton A. Glantz

Suman Paranjape

T Stevenson

Thomas Kyriss

VB Yerger

English

PubMed

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PLoS Medicine

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

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.Please see later in the article for the Editors' Summar

Wertz Marcia S.

Kyriss Thomas

Paranjape Suman

Glantz Stanton A.

Public Library of Science (PLOS)

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

Marcia S Wertz

Stanton A Glantz

Directory of Open Access Journals

The toxic effects of cigarette additives. Philip Morris' project mix reconsidered: an analysis of documents released through litigation.

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

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