The Science Behind the Tobacco Heating System
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The Science behind the Tobacco Heating System A Summary of Published Scientific Articles Maurice Smith, Christelle Haziza, Julia Hoeng, Frank Lüdicke, Serge Maeder, Patrick Vanscheeuwijck, Manuel C. Peitsch Philip Morris International Preamble very contemporary platform called sbvIMPROVER to foster the verification of both our methods and We recognize that cigarettes are a dangerous results by independent scientists. We have also product, and it is well known that the best way to recently launched an Investigator Initiated Study avoid the harms of smoking is never to start, or to program, a first step towards encouraging third quit. Nevertheless, based on the World Health parties to conduct studies with our RRPs. Organization’s own predictions, there will be more than one billion smokers by the year 2025. In this document, you will find a summary of our Therefore, alternative products that significantly scientific publications describing the assessment reduce the risk of disease compared with of THS2. If you have any comments or questions cigarette smoking are a fundamental complement about our science, be it about the methods we to the regulatory efforts aimed at reducing use or the results we have obtained, let us know. smoking prevalence. We look forward to hearing from you. WE HAVE BROUGHT TOGETHER OVER 300 WORLD- Prof. Manuel C. Peitsch CLASS SCIENTISTS FROM 30 FIELDS OF EXPERTISE – Chief Scientific Officer INCLUDING TOXICOLOGY, SYSTEMS BIOLOGY AND MEDICINE – TO DEVELOP AND ASSESS PRODUCTS Declaration of Interest THAT HAVE THE POTENTIAL TO REDUCE INDIVIDUAL RISK AND POPULATION HARM All studies presented and referenced in this COMPARED WITH SMOKING. document were fully funded by Philip Morris International. All authors are (or were) employees For this reason, PMI is investing in the of, or contracted by, Philip Morris International. development and rigorous assessment of a portfolio of potentially reduced-risk alternatives Electronic Version to cigarette smoking. In fact, our objective is to replace cigarettes with RRPs1 as soon as possible. This document is available from PMIScience.com The scientific work we’re conducting is at the at: heart of this transformation. Our approach is https://www.pmiscience.com/library/pmi- based on the acknowledgment that innovative science-ths-executive-summary products will benefit public health if they meet two conditions: first, they must significantly reduce risk of disease compared with cigarettes; and, second, they must be acceptable enough to smokers to encourage them to switch to such reduced-risk alternatives. In order to demonstrate that switching to our RRPs results in a significant reduction in the risk of disease compared with cigarette smoking, we are following a rigorous scientific assessment program that we outline in this document. Our program is in line with the draft guidance from the U.S. Food and Drug Administration (FDA) for Modified-Risk Tobacco Products (MRTPs). In December 2016, we submitted our MRTP Application to the FDA. We recognize that our scientific work must also be Version: October 2017 assessed by independent experts. We welcome such review and are committed to share scientific data for independent verification by qualified third parties. Towards this end we are utilizing a 1 Reduced-Risk Products (“RRPs”) is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continued smoking. We have a range of RRPs in various stages of development, scientific assessment and commercialization. Because our RRPs do not burn tobacco, they produce far lower quantities of harmful and potentially harmful compounds than found in cigarette smoke. 2 The studies described in this documents were conducted with THS 2.2. THS is commercialized under the name IQOS. Table of Contents The Scientific Assessment of THS ...................................................................................................... 1 Tobacco harm reduction and the need for innovative approaches .................................................. 1 Heating rather than burning tobacco ............................................................................................... 2 THS: A novel product that heats tobacco ......................................................................................... 3 Scientific assessment of the Tobacco Heating System ..................................................................... 3 THS development and assessment ................................................................................................... 4 Conclusions ..................................................................................................................................... 17 References ...................................................................................................................................... 18 Appendix A: Absence of Combustion in THS Leads to Reduced HPHC Formation and Emission .... 22 I. Evidence for absence of combustion. .......................................................................................... 22 II. Evidence that the THS yields reduced levels of HPHCs. .............................................................. 25 III. Evidence that THS does not negatively impact indoor air chemistry. ........................................ 29 References ...................................................................................................................................... 31 Appendix B: Systems Toxicology & Verification .............................................................................. 33 I. A short introduction to systems toxicology ................................................................................. 33 II. A short introduction to verification ............................................................................................ 35 References ...................................................................................................................................... 36 Appendix C: Scientific References and Abstracts about THS 2.2 and Key Methods ........................ 37 Description of the assessment program ......................................................................................... 37 I. THS 2.2 assessment studies ......................................................................................................... 37 II. Key Methods developed by PMI ................................................................................................. 47 Appendix Z: Quality Management System ……………………………………………………………………………………..I List and Status of THS Assessment Studies………………………………………………………………………………………II The Scientific Assessment of THS1 Executive Summary Philip Morris International R&D abstinent than those who are seen by a general Tobacco harm reduction and the need for practitioner and people who receive group innovative approaches behavioral support are three times more likely to Worldwide, there are about 1.1 billion smokers stop smoking. However, at a 1-year follow-up, (Ng 2014) and nearly six million deaths annually despite these interventions, only 8% of smokers are attributed to tobacco smoke (World Health remain abstinent from smoking (Dobbie 2015). Organization 2009). For many decades, the primary “Harm reduction is a strategy used in medicine strategies for reducing the harm associated with and social policy to minimize harm to individuals cigarette smoking was focused on preventing and/or wider society from hazardous behaviors or smoking initiation and promoting smoking practices that cannot be completely avoided or cessation. Although smoking prevalence has prevented” (Royal College of Physicians 2016). In this declined in many countries over the last forty context, Tobacco Harm Reduction is starting to years, in the last ten years those declines have gain support from a range of stakeholders – flattened in many countries. Smoking causes a including public health organizations, healthcare number of serious diseases including professionals and regulators – to complement the cardiovascular diseases, lung cancer and chronic existing strategies to reduce smoking prevalence. obstructive pulmonary disease (COPD). According to the Royal College of Physicians, Smoking cessation is clearly the most effective embracing such an approach could offer a means strategy for smokers to reduce their risk of harm to prevent millions of deaths (Royal College of and disease. However, the number of former Physicians 2007). For example, in May 2014, 53 smokers who relapse is high since approximately prominent public health experts and leading 80% of smokers who attempt to quit return to scientists from over 18 countries wrote an open smoking within one month, and only letter to the World Health Organization (WHO) approximately 5% of smokers successfully quit urging the organization to support Tobacco Harm each year (Tashkin 2015). Smoking is both an Reduction2. They wrote: addiction to nicotine and a conditioned habit “There are now rapid developments in triggered by various environmental cues, and nicotine-based products that can effectively smokers enjoy the rituals associated with smoking substitute for cigarettes but with very low (Fagerström 2012). Nicotine replacement therapies risks. These include, for example, e-cigarettes (NRTs) (e.g. patches, gums, inhalers) are designed and other vapour products, low-nitrosamine to deliver nicotine and