Q&A interview with Nuno Fazenda in Russian regional business daily “Delovoy Kvartal” - English translation below:
Three years ago, Philip Morris International (PMI) began to launch IQOS, an innovative product built on the principle of "Heat-Not-Burn" technology. IQOS, along with e-cigarettes, represents for smokers who fully switch to this product a potentially safer alternative than continued smoking. A HeatStick that contains specially designed tobacco is inserted into the device. It does not burn or smolder, as the electronics control the device to heat the tobacco to a temperature of not more than 350C, much lower than combustion temperature (when the cigarette is ignited, the temperature at its tip reaches 850 -900 C), resulting in the formation of tobacco vapor (aerosol). The system produces no smoke, no ash, and much less odor. IQOS is not an abbreviation, but a unique name chosen as it conveys an image of modernity and technology.
A serious team of more than 400 scientists, engineers and other specialists from around the world was involved in IQOS’s development (as well as three other innovative platforms) at the PMI research centers in Switzerland and Singapore on research and development. More than USD 3 billion was spent over ten years on just the fundamental research and early production.
Nuno Fazenda, Manager Scientific Engagement, in an interview with DK.RU, described how the tobacco company came to the decision to build a smoke-free future, how their conventional cigarette products would be replaced, and how the company is saving smokers from tobacco smoke.
Vapor Instead of Smoke
In the mid-2000s, worldwide production of e-cigarettes began to appear quickly, designed as an alternative to conventional cigarettes. Over the past three years, the number of electronic device users in Russia has almost doubled: Today, 1.4% of Russians use e-cigarettes every day, while in 2015 this number was 1.1%, and 0.8% in 2014. For comparison: in the US, 5.2% of smokers use e-cigarettes, in Italy - 4.7%, and in the UK - 4.1% (statistics referenced from Kantar Agency).
The electric tobacco heating system appeared relatively recently. PMI was the first company to develop it, and a similar product called Glo was brought to the market by British American Tobacco last year.
Recently, smoking has become unfashionable, with cigarette sales falling significantly. Was this the reason for the development of PMI’s alternative products?
NF: Indeed, the smoking rate over the past 40 years, has declined in many countries. But as the general population of people grows, the coming years will not see a decrease in the number of smokers. According to the WHO, in the next decade, there will be more than 1 billion smokers. So, when PMI started developing smoke-free products, it was not motivated by this reason.
NF: Understand, that despite the widespread propaganda of smoking’s harm, people still continue to smoke. And the health risks are high: according to medical research, the main cause of diseases are the toxic carcinogenic substances contained in the smoke. Therefore, our first task was to minimize these risks, eliminating the major harmful components of conventional cigarettes - tar and the products of combustion. And also, to offer a reduced risk product to adult smokers who do not want to give up the habit.
IQOS HeatSticks contain nicotine, just like in cigarettes. Is it really safe?
NF: Of course, nicotine causes dependence and is not completely harmless, however, contrary to popular belief, nicotine is not the main cause of smoking-related diseases. The main risk is in the harmful substances contained in cigarette smoke. Leading health organizations, including the US FDA, agree that two methods are effective for reducing smoking-related diseases: preventing new smokers and facilitating complete cessation of smoking, while at the same time providing smokers with alternative tobacco products.
How do these alternative products work?
NF: If we are speaking about IQOS, then during development, our task was to create a product that would reduce health risks and satisfy the needs of smokers. IQOS consists of a holder and a charger. A HeatStick is placed in the holder, which is heated by means of an electric heating device. The method of tobacco processing used in HeatSticks is different from the standard. The tobacco is treated in a special way which allows it to release nicotine at a lower temperature. In the holder is a special blade, which heats the tobacco, the temperature does not rise above 350 degrees, all controlled by precise electronics. As a result, the aerosol inhaled by the user contains significantly less harmful substances than the smoke of a conventional cigarette, while maintaining the taste of the tobacco.
Our company has a whole portfolio of innovative products - not only IQOS, but also e-cigarettes and other products utilizing an alternative system for nicotine delivery. These products are at different stages of development and commercialization, and are present in the markets of some countries.
How did IQOS enter the market?
NF: Japan was the first market where we launched the new product. We started with a pilot project in Nagoya in 2014. Now IQOS is sold in 28 countries, and by the end of the year, we plan to launch the product in the largest cities of 30-35 countries. Currently, our market-share in Japan is 12.7%, and 14.8% in Tokyo, and it continues to grow.
Why was Japan chosen specifically for the launch, and how did they perceive the tobacco heating system?
NF: The Japanese are well-aware of innovations, especially if it is related to technical development. In addition, due to the social and cultural characteristics of Japan, people in general, and smokers in particular, are careful not to disturb others. Therefore, it was especially important for them that there is no ash, and also less smell than when smoking cigarettes, when using the electric tobacco heating system. Furthermore, the IQOS aerosol does not negatively affect the indoor air quality.
In Russia, the conditions and mentality are completely different. How many consumers switched to IQOS in our country?
NF: Not so many. Currently, the device is represented in only seven cities with populations over one million, including the capital. In the second quarter of 2017, the market-share of HeatSticks for IQOS was 0.6% in Moscow (according to AC Nielsen). But the conversion rate is large enough. According to our data, more than 70% of adult smokers who bought IQOS in Moscow and St. Petersburg completely or predominately switched to it.
PMI conducts a phased and comprehensive scientific evaluation of its innovative products, based on practices used for many years in the pharmaceutical industry and in compliance with international standards. With all the scientific developments PMI patents, they now hold the 63rd place among companies that patent their innovations in Europe. Of note, PMI is the only tobacco company on this list.
What kind of research does the company perform before introducing a product to the market?
NF: First, we conducted preclinical studies to evaluate the toxicity of the product. Results of the research show that the level of harmful substances is reduced on average by 90-95% when compared to cigarette smoke. And the toxicity was also substantially reduced. This gave us confidence that the product had the potential to be much less harmful.
Scientists have not yet come to an agreement on which components of tobacco smoke cause specific diseases. Which substances did you measure?
NF: We took a list of substances contained in tobacco smoke. By the way, the PMI research center investigates 58 substances, but, for example, the IARC lists only about 15 substances. After we were convinced that the smoke-free product is at least no more toxic than cigarettes (actually much less toxic), we proceeded to clinical studies. Two key tests were conducted in Japan and the US over five days. Participants in the study were divided into three groups: those who switched from cigarettes to IQOS; those who continued to smoke cigarettes; and those who quit smoking altogether. We measured the concentration of harmful substances (such as carbon monoxide, benzene, acrolein, butadiene) in all of the participants’ blood and urine daily. As a result, these clinical studies showed that a substantial reduction in the exposure to the harmful substances in the smokers who switched to the innovative product, as well as the normalization of their biological and functional indicators, similar to the changes observed when a person quits smoking. Two further three-month studies showed similar results. But, of course, we do not say that results are final: research continues, and final conclusions about the reduced health risk will be made on the basis of a full and convincing scientific and evidence base.
Time of Standards
On July 1, 2017, the national standard for heated tobacco came into force in Russia, developed by the All-Russian Research Institute of Tobacco, Makhorka and Tobacco Products (Krasnodar). Up until today, there were no regulatory documents controlling the production of these heated tobacco, and the Russian Federation became the first country to introduce a national standard for heated tobacco.
"This standard could potentially become the basis for regulating innovative tobacco products for the world, and Russia, as a member of the International Organization for Standardization (ISO), could initiate the development of an international standard for heated tobacco," comments Nuno Fazenda.
A standard is necessary so that new products are introduced with technical requirements and quality control methods. Now, products within this category can be identified, and this will provide for basic requirements of quality and safety.
"First of all, when we develop innovative products, we are trying to reduce the risk for the smoker and his health. But for us, the impact our products will have on the health of society as a whole is no less important, “explains Mr. Fazenda.
But how can you switch smokers to this innovative tobacco heating system? This is still a fundamentally different product.
NF: This is the second aspect that our scientists are working on. It is necessary that smokers receive a similar level of satisfaction they were receiving from smoking. Having this, they can more easily move away from cigarettes towards innovative products. After all, even if we have some super-product with zero risks, but does not satisfy the smoker, no one will switch to it. Therefore, we always think of how to make products attractive to smokers, not just how to reduce harm.
Are there any concerns non-smokers will start using IQOS, after seeing the popularization of your products?
NF: Good question. We specifically conducted surveys among a large number of adult respondents in the United States. Out of 10,000 people, less than 5% of adult smokers expressed their intention to use IQOS, and less than 1% have never smoked. But perhaps even more encouraging, research from Japan after we launched shows that initiation is only occurring in the very low single digits. However, IQOS is not a product that should encourage a person to start smoking. This is an alternative for those who are not ready to give up nicotine-containing products and want to switch from cigarettes to a better product.
How will this affect cigarette production, do you plan to reduce their numbers?
NF: Our goal is to ultimately phase out from cigarettes. However, the exact pace for this transition will depend on the pace at which consumers will switch to these new products. In this regard, others will also have a role to play in encouraging this transition.
Dr. Nuno Fazenda joined Philip Morris International (PMI) in 2011 and currently serves as Manager Scientific Engagement, in charge of creating awareness on the scientific approach and efforts related to PMI’s smoke-free products. Dr. Fazenda holds a PhD from the Swiss Federal Institute of Technology (EPFL) and worked in the medical devices industry prior to joining PMI.