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Gerlingen, Germany

Kyriss T.,Schillerhoehe Hospital | Schneider N.K.,German Cancer Research Center
Tobacco Control | Year: 2013

Background Tobacco-specific nitrosamines (TSNAs) are a group of carcinogens, which originate from nicotine and other tobacco alkaloids during fermentation and burning of tobacco. Between 1990 and 2010, the tobacco industry-funded extensive academic research on TSNAs in Germany. The objective was to gain better knowledge of how industry aims and strategies correlate with contents of publications by German toxicologists accepting tobacco industry funding by focusing on one prominent such toxicologist. Methods and findings The authors analysed previously secret tobacco industry documents that were disclosed following a series of litigation cases in the USA and compared them with peer-reviewed published results of tobacco industry-funded toxicologists. The tobacco industry, in particular Philip Morris, developed sophisticated strategies to downplay TSNA's carcinogenic potential. Over 2 decades, German toxicologist Elmar Richter, faculty member of the renowned Ludwig-Maximilians-University, Munich, received substantial financial support from the tobacco industry. Numerous publications show that his research findings supported the aims of the tobacco industry. In his commissioned work, he suggested that TSNA burden can be explained by misclassification of smokers or assay background levels caused by TSNA-like molecules from food. Other publications cast doubt on the relevance of animal testing for TSNAs to humans claiming a detoxifying effect of nicotine on the metabolism of TSNAs or suggesting that adducts of TSNAs are unsuitable as biomarkers of exposure to tobacco smoke. Conclusions Economic interests of the tobacco industry have strongly influenced the research activity of Richter and his group. The publications of his working group about carcinogenic effects of TSNAs published between 1992 and 2009 should therefore not be regarded as independent. Scientists and policy makers should consider the long-standing and intensive inter-relation between certain toxicologists and the tobacco industry when assessing the research results and consider ignoring them.

Tan C.E.,University of California at San Francisco | Kyriss T.,Schillerhoehe Hospital | Glantz S.A.,University of California at San Francisco
PLoS Medicine | Year: 2013

Background:Spurred by the creation of potential modified risk tobacco products, the US Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to assess the science base for tobacco "harm reduction," leading to the 2001 IOM report Clearing the Smoke. The objective of this study was to determine how the tobacco industry organized to try to influence the IOM committee that prepared the report.Methods and Findings:We analyzed previously secret tobacco industry documents in the University of California, San Francisco Legacy Tobacco Documents Library, and IOM public access files. (A limitation of this method includes the fact that the tobacco companies have withheld some possibly relevant documents.) Tobacco companies considered the IOM report to have high-stakes regulatory implications. They developed and implemented strategies with consulting and legal firms to access the IOM proceedings. When the IOM study staff invited the companies to provide information on exposure and disease markers, clinical trial design for safety and efficacy, and implications for initiation and cessation, tobacco company lawyers, consultants, and in-house regulatory staff shaped presentations from company scientists. Although the available evidence does not permit drawing cause-and-effect conclusions, and the IOM may have come to the same conclusions without the influence of the tobacco industry, the companies were pleased with the final report, particularly the recommendations for a tiered claims system (with separate tiers for exposure and risk, which they believed would ease the process of qualifying for a claim) and license to sell products comparable to existing conventional cigarettes ("substantial equivalence") without prior regulatory approval. Some principles from the IOM report, including elements of the substantial equivalence recommendation, appear in the 2009 Family Smoking Prevention and Tobacco Control Act.Conclusions:Tobacco companies strategically interacted with the IOM to win several favored scientific and regulatory recommendations.Please see later in the article for the Editors' Summary. © 2013 Tan et al.

Ehmann R.,Ambulante Pneumologie | Boedeker E.,Schillerhoehe Hospital | Friedrich U.,TeamCanin | Sagert J.,TeamCanin | And 3 more authors.
European Respiratory Journal | Year: 2012

Patient prognosis in lung cancer largely depends on early diagnosis. The exhaled breath of patients may represent the ideal specimen for future lung cancer screening. However, the clinical applicability of current diagnostic sensor technologies based on signal pattern analysis remains incalculable due to their inability to identify a clear target. To test the robustness of the presence of a so far unknown volatile organic compound in the breath of patients with lung cancer, sniffer dogs were applied. Exhalation samples of 220 volunteers (healthy individuals, confirmed lung cancer or chronic obstructive pulmonary disease (COPD)) were presented to sniffer dogs following a rigid scientific protocol. Patient history, drug administration and clinicopathological data were analysed to identify potential bias or confounders. Lung cancer was identified with an overall sensitivity of 71% and a specificity of 93%. Lung cancer detection was independent fromCOPD and the presence of tobacco smoke and food odours. Logistic regression identified two drugs as potential confounders. It must be assumed that a robust and specific volatile organic compound (or pattern) is present in the breath of patients with lung cancer. Additional research efforts are required to overcome the current technical limitations of electronic sensor technologies to engineer a clinically applicable screening tool. Copyright©ERS 2012.

Hampel M.,University of Stuttgart | Dally I.,University of Stuttgart | Walles T.,Fraunhofer Institute for Interfacial Engineering and Biotechnology | Steger V.,Schillerhoehe Hospital | And 3 more authors.
European Journal of Cardio-thoracic Surgery | Year: 2010

Objective: In the treatment of advanced stages of lung cancer, increasingly more multimodality approaches applying radiotherapy and/or chemotherapy in a neo-adjuvant setting are being introduced. The impact of induction therapy, especially radiotherapy, on bronchial tissue viability has not been investigated so far. Methods: In 2008, we determined the tissue viability of bronchial segments obtained during surgery in 45 consecutive patients, including patients after neo-adjuvant radiochemotherapy (RCTX). Bronchial tissue viability was analysed by histology, life-dead assay and cell proliferation in tissue-specific culture media. Biomedical findings were compared with the clinical course of the patients. Results: Tissue samples of 44 patients were included into this study. Fourteen patients (32%) had undergone neo-adjuvant RCTX. Histology and life-dead assay of the bronchial segments did not show significant differences. While patient age, sex, tumour entity and site of resection had no influence on cell proliferation in vitro, previous RCTX resulted in a 46% decrease of bronchial tissue viability (P = 0.01). However, this effect was not reflected by the clinical course of the operated patients. Conclusions: Neo-adjuvant RCTX reduces bronchial tissue viability substantially. However, this impairment does not necessarily translate into an increased rate of postoperative bronchial insufficiencies. Standard histological work-up is not sensitive enough to characterise changes in bronchial tissue viability following RCTX. © 2009 European Association for Cardio-Thoracic Surgery.

Boedeker E.,Schillerhoehe Hospital | Friedel G.,Schillerhoehe Hospital | Walles T.,Schillerhoehe Hospital
Interactive Cardiovascular and Thoracic Surgery | Year: 2012

Lung cancer (LC) continues to represent a heavy burden for health care systems worldwide. Epidemiological studies predict that its role will increase in the near future. While patient prognosis is strongly associated with tumour stage and early detection of disease, no screening test exists so far. It has been suggested that electronic sensor devices, commonly referred to as 'electronic noses', may be applicable to identify cancer-specific volatile organic compounds in the breath of patients and therefore may represent promising screening technologies. However, three decades of research did not bring forward a clinically applicable device. Here, we propose a new research approach by involving specially trained sniffer dogs into research strategies by making use of their ability to identify LC in the breath sample of patients. © The Author 2012. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

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