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By Dr. Moira Gilchrist, Vice President Strategic & Scientific Communications, Philip Morris International
There is strength in numbers — this applies to every aspect of life, and science is no exception. As the past year-and-a-half has shown us, there can be extraordinary progress when scientists from a wide range of fields come together in a concerted effort. In this case, the common foe has been the global pandemic.
The power of interdisciplinary scientific work is often overlooked but carries with it amazing potential. One such example — perhaps surprising for some — is the science that has transformed my company, Philip Morris International (PMI). We are now on a path to one day, hopefully soon in many countries in which we operate, completely replace cigarette sales with smoke-free alternatives that are a better choice for the people around the world who smoke today. These are nicotine-containing products that do not burn tobacco, which — while not risk-free — are a much better choice than continuing to smoke.
PMI’s program to develop and scientifically substantiate these smoke-free products is led by a team of more than 430 scientists and R&D experts who cover approximately 30 disciplines, including materials science, consumer electronics, clinical science, and systems toxicology. Their collective work contributes to a comprehensive scientific assessment program, which we developed over more than a decade, following practices used in the pharmaceutical industry and guidance from the U.S. Food and Drug Administration (FDA).
Following a phased approach, this program covers our smoke-free product development from beginning to end. That is from the product’s design until after it reaches its intended audience — adult smokers who would otherwise continue to smoke.
The fundamental principle that drives our scientific work is the widely accepted fact that nicotine — while addictive and not risk-free — is not the primary cause of smoking-related disease. It’s the burning of tobacco that creates the harmful chemicals in cigarette smoke — which is why from the outset we design our smoke-free products to eliminate burning, thus eliminating smoke while providing an alternative that smokers find acceptable and will actually use.
The quality of the product design and the strict adherence to high manufacturing standards is vital to ensuring our smoke-free products deliver a consistent aerosol. The next step involves laboratory testing to determine if the levels of toxic compounds and the product’s toxicity are reduced compared with cigarette smoke. Then follows clinical studies among adult smokers to understand whether switching to a smoke-free product reduces their exposure to toxic compounds and whether this leads to a favorable change in clinical risk markers that are linked to smoking-related diseases.
To date, we have conducted over 18 nonclinical and 11 clinical studies, involving thousands of participants in America, Asia, and Europe, all in accordance with internationally accepted standards and practices such as the Good Laboratory Practices and Good Clinical Practices.
Our assessment is supplemented by consumer use research, including several types of perception and behavioral studies to better understand how smokers perceive a product’s risk-reduction profile and how they use it under real-life conditions. Importantly, we verify that never and former smokers understand that smoke-free products are not intended for them. The last, but equally important phase, is our long-term assessment once the products are placed on the market to evaluate their potential to reduce the harm associated with tobacco use.
As a scientist with a background in the development of pharmaceutical products, I couldn’t be prouder of the best-in-class program we have at PMI. Of course, conducting research is only half of a scientist’s duty, which is why another critical priority for us is to ensure our scientific findings are both verifiable and transparent.
To achieve this, we have made substantial efforts to widely share our scientific findings, including in peer-reviewed publications, at scientific events, on dedicated online platforms, and through crowd-sourced initiatives. In addition, we consistently invite the scientific community and regulators to study our science, verify our results, and conduct their own independent research. To date, more than 160 independent publications have examined our science. And while most have arrived at conclusions largely in line with ours, we ensure that we publish all available independent studies on our website — even when we disagree with the methodology followed or the conclusions reached.
Once thought impossible, a smoke-free future is within reach for my company thanks to innovations in science and technology. At PMI, we’re committed to delivering this future and aim to be a majority smoke-free business by the end of 2025. Regulators, the public health community, and civil society can accelerate change by objectively assessing the science that underpins smoke-free products and the potential they represent for those adults who continue to smoke. Objective examination of the science is vital to enable the dialogue needed to deliver on the promise of innovative, better choices for smokers.