But what about nicotine?

Health experts agree that the main cause of harm from smoking is the presence of toxic chemicals found in smoke generated by the burning of tobacco – not the nicotine.

Decades of scientific research show that while nicotine is addictive and not risk-free, it is not the primary cause of smoking-related diseases. When a cigarette is lit, it is the burning of tobacco and other materials that produces thousands of chemicals, many of which are widely recognised as being associated with the development of smoking-related diseases.

This information is important for the millions of smokers that pharmacists advise each day. It is also key for companies designing smoke-free products that significantly reduce or eliminate the formation of these chemicals, whilst emulating as much as possible the taste, nicotine delivery and ritual characteristics of cigarettes.

PMI’s contribution to tobacco harm reduction

Within the tobacco industry, Philip Morris International (PMI) has spent over a decade developing alternatives for consumers who are seeking better options, and who would otherwise continue to smoke.

Since 2008, PMI has invested over USD 7.2 billion in fundamental research, product development, scientific substantiation and manufacturing capacity of smoke-free products, including the construction of PMI’s R&D facility. It has hired over 430 world‑class scientists, engineers and experts from fields including material science, consumer electronics, chemistry, toxicology, systems biology, medicine and epidemiology, who are working to develop and assess a number of non-combustible nicotine and tobacco products that have the potential to significantly reduce individual risk when compared with smoking, and yet are satisfying enough for adult smokers in replicating the taste, satisfaction and ritual characteristics associated with cigarettes.

One of PMI’s smoke-free products, called IQOS, emits, on average, 95 per cent lower levels of harmful chemicals compared to cigarettes*. However, unlike e-cigarette vaping, IQOS uses real tobacco, which it heats but does not burn. With over 16 million users worldwide, 11 million of which have abandoned cigarettes completely5, IQOS uses a novel tobacco heating system technology, which reduces customer exposure to harmful chemicals. PMI is undertaking post-market surveillance and research to monitor the long-term effects of its smoke-free products.

On 7 July, 2020, the Food and Drug Administration (FDA), the government agency responsible for protecting public health in the United States, made a historic decision in authorising IQOS to be marketed in the US as a modified risk tobacco product (MRTP), with a reduced exposure claim6. In taking their decision, IQOS is the first and only tobacco heating system that has completed the US FDA Modified Risk Tobacco Product application process, concluding that switching completely to IQOS reduces your body’s exposure to harmful or potentially harmful chemicals7. This decision, by one of the world’s leading health regulatory organisations, is an important milestone in the journey towards a smoke-free future.

The science behind IQOS

PMI’s goal for switching smokers to smoke-free products is to reduce their risk of developing smoking-related diseases. Within this framework, PMI takes a thorough, systematic and stepwise approach for the continued development and assessment of these products.

The process starts with the initial design and engineering of the product platform, a fundamental step in ensuring quality and consistency. Molecular, cellular and physiological research is then carried out in PMI’s state-of- the-art research facilities, followed by human clinical studies which are used to determine exposure and riskreduction potential. Results of these studies are then published in respected, peer-reviewed scientific journals, available for scrutiny by the global scientific community and general public. Finally, PMI undertakes postmarketing surveillance studies and conducts research on smokers’ long-term, real-world use of its products. Strict scientific standards are applied at each step, which form the basis of comprehensive evidence to support product claims. All PMI’s data is available to view on its Science INTERVALS platform: intervals.science.

IQOS: the facts

The totality of evidence, which comprises PMI’s aerosol chemistry, molecular, physiological, clinical and non-clinical data, demonstrates that completely switching to IQOS, while not risk-free, reduces customer exposure to harmful compounds when compared to smoking cigarettes.

More precisely, PMI’s studies8 to date on IQOS have found that:

  • IQOS involves no combustion and generates no smoke
  • IQOS on average emits 95 per cent lower levels of harmful and potentially harmful chemicals compared to cigarette smoke*
  • IQOS aerosol contains nicotine at similar levels as cigarette smoke. Peer-reviewed and journal-published laboratory studies, conducted by PMI, confirm that these lower levels of toxicants result in the aerosol generated by IQOS being significantly less toxic than cigarette smoke8.

Clinical studies conducted to date support the risk reduction potential of IQOS. PMI’s six-month clinical Exposure Response Study9 successfully met its objective, showing improvements in the biological response of people who switch to IQOS compared to continued smoking.

IQOS use does not adversely affect indoor air quality, and is not a source of second-hand smoke. Additionally, PMI’s research shows that there is very low interest in IQOS among people who have never smoked or those who quit smoking, whilst there is substantial potential for full switching among adult smokers.

Gathering feedback from a wide range of external experts is central to PMI’s assessment program. That means an ongoing dialogue with regulators and experts in the scientific and public health communities. It also means regularly sharing scientific methods and data. Since 2008, PMI has published more than 340 smoke-free product-related studies and book chapters in peer-reviewed publications, such as the American Journal of Physiology, Nature Biotechnology, and Regulatory Toxicology and Pharmacology, and over the last two years, PMI has presented their results at over 150 scientific conferences around the world.

Continuously welcoming independent expert verification is also important. To this end, a variety of experts and institutions around the world have independently reported the lack of combustion in IQOS, as well as its reduced emission levels of toxicants compared to cigarettes. PMI encourages other organisations to undertake their own scientific studies with IQOS.

Given the ongoing challenge that smoking presents to public health in the UK and the reluctance of many smokers to embrace cessation or vaping products, pharmacists can play an important role in informing smokers of emerging alternatives, such as heated tobacco, which could help the UK stamp out smoking forever.

Panel sees merit in the science and wants to hear more

Pharmacists will need a good understanding of the science behind the ‘heat-not-burn’ IQOS device in order to inform smokers who wish to reduce their risk without stopping tobacco use completely, according to a P3pharmacy expert panel.

Members of a P3pharmacy expert panel, meeting virtually on October 8, quizzed PMI vice-president of strategic and scientific communications, Dr Moira Gilchrist, on the science behind the company’s reduced risk IQOS product. Chaired by P3pharmacy editor Rob Darracott, the panel sought the detail behind the claim that heating tobacco to 350°C rather than burning it at 600‑800°C resulted in 95 per cent lower levels of thousands of toxic chemicals in cigarette smoke, including around 100 specifically identified by the US Food and Drug Administration as particularly significant.

Dr Gilchrist, who initially trained as a pharmacist, said that IQOS is not available through UK pharmacies, at present. However, PMI is keen to ensure that pharmacists, given their important role in providing lifestyle advice, understand the options available when deciding what might be best for every customer. Dr Gilchrist suggested that people who were unable or unwilling to give up tobacco might still want to manage their risk if they knew that option was available to them.

She recognised it was often easier for professionals to say ‘We don’t know enough, so let’s not do anything’; PMI wants to get to a place where people can say ‘We probably know enough to make a reasonable judgement, and this could be a positive step forward’.

The panel agreed that it had been valuable to hear more of the detail of the thinking and the research behind the ‘heat-not-burn’ technology. Most admitted they had known little about IQOS beforehand. One participant said: “It’s important for me to know about products like this and I’d be open to learning a lot more. I want to be in a position to know about these things if my customers ask.”

Another said: “As an ex-smoker, I know it’s difficult to move over to a product, like nicotine replacement therapy, that doesn’t give you anything like the experience smoking does. If there’s an intermediate route, with the possibility of looking at nicotine addiction down the line, I can only see that as a positive. Having a product with a lot of research behind it makes me more comfortable in recommending it.”

Panel members had mixed views about the acceptability, for pharmacists, of aiming to reduce risk when for years they had been trained to see removing it completely via a smoking cessation quit as the gold standard outcome. While one felt pharmacists were increasingly comfortable with the concept of risk reduction and were ready to accept that people had options other than “the nirvana of smoking cessation”, another was less convinced, saying that for years pharmacists had been trying to wean patients off nicotine.

A third said: “I can see that it’s best to quit completely, but I’d rather see my patients move onto something like this than carry on smoking cigarettes.”

Most members of the panel felt that the views of regulators and authorities like Public Health England (PHE) were important, if not critical. One said: “Pharmacy is an over-regulated profession and people will have in the back of their minds, ‘What does the regulator think about this?’”

Another said that public health departments and health professionals had been guided on the efficacy and safety of vaping by an expert independent evidence review published by PHE. This was acknowledged by the National Centre for Smoking Cessation and Training (NCSCT) who produced an e-cigarettes briefing for stop smoking services.

One panel member was concerned about the long-term implications and said: “I think we’re going to have some real challenges in pharmacy to try and recommend something that is harm reducing rather than harm removing. I see a need for this for hard-to-reach people, but I want to know what the implications are for me to recommend something.”

The panel accepted that, as newer technology, IQOS was some years behind e-cigarettes in independent assessment, so it may be some time before a statement arrives similar to PHE’s assertion that vaping is 95 per cent less harmful than smoking.

One panel member felt that the continued presence of tobacco would be a problem for some, saying: “This might be a lot safer, but it is still tobacco. That’s going to be a grey area for a lot of pharmacists.” Another recognised that the history of the tobacco industry might be a problem for older pharmacists, but said the investment PMI was making in the technology should be seen as a positive: “The knee-jerk reaction is suspicion, but I am reassured by the quality control in this product compared with some of the e-cigarettes I’ve seen handed into the pharmacy.”

The panel felt it had been particularly helpful to be able to hear the views of others from across the profession when hearing information for the first time, and when they were being challenged to consider a paradigm shift in an established area of activity.

REFERENCES 1. Public Health England, Health Matters: Stopping smoking - what works? Published Sept. 2018; updated Dec 2019. 2. World Health Organization Publications, The Tobacco Atlas, Judith Mackay and Michael Eriksen, 2002. 3. Cancer Intelligence Team, Cancer Research UK. Smoking prevalence projections for England, Scotland, Wales, and Northern Ireland, based on data to 2018/19. Published February 2020 4. Hajek P, Phillips-Waller A, Przulj D, Pesola F, Myers Smith K, Bisal N, Li J, Parrott S, Sasieni P, Dawkins L, Ross L, Goniewicz M, Wu Q, McRobbie HJ. A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy. N Engl J Med. 2019 Feb 14;380(7):629-637. 5. Philip Morris International, 2020 Third-Quarter Results, October 20, 2020 6. FDA’s marketing order for the IQOS system, dated July 7, 2020. 7. PMI 3-month reduced exposure studies conducted in Japan and the US in near real world conditions. These studies measured exposure to 15 harmful chemicals, and compared to the levels observed in smokers who switched to IQOS with levels measured in smokers who continued to smoke cigarettes. 8. pmiscience.com/library 9. Lüdicke F, Ansari SM, Lama N, Blanc N, Bosilkovska M, Donelli A, Picavet P, Baker G, Haziza C, Peitsch M, Weitkunat R. Effects of Switching to a Heat-Not-Burn Tobacco Product on Biologically Relevant Biomarkers to Assess a Candidate Modified Risk Tobacco Product: A Randomized Trial. Cancer Epidemiol Biomarkers Prev. 2019 Nov;28(11):1934-1943. doi: 10.1158/1055-9965.EPI-18-0915. Epub 2019 Jul 3. PMID: 31270101.

Important information: IQOS is not risk-free. It delivers nicotine, which is addictive.

*

IQOS emits 95% lower levels of harmful chemicals compared to cigarettes.*

Important information: It does not necessarily equal a 95% reduction in risk. IQOS is not risk-free.

*Average reductions in levels of a range of harmful chemicals (excluding nicotine) compared to the smoke of a reference cigarette (3R4F).

Content developed by Philip Morris Limited working together with P3pharmacy ©Communications International Group