Gizelle Baker, VP Global Scientific Engagement at PMI: Science is the accelerator of our goal of reaching a smokefree future

After working for several years in the U.S. at pharmaceutical companies and researching on
cancer treatments and cardiovascular disease, Dr. GIZELLE BAKER decided to take the step to prevention. He joined Philip Morris, determined to make progress in the health of society. His professional motto is: We must follow Science!

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You are VP Global Scientific Engagement at PMI. Please can you tell us what is your role within PMI and what do you do daily?

At Philip Morris International, I lead a team of scientists behind PMI’s noncombustible alternatives to smoking. There are more than 980 people conducting the scientific research and developing technology—really focused on the scientific understanding of tobacco harm reduction and our smoke-free products.

Science is the accelerator of our goal of reaching a smokefree future. The innovative approach of our diverse team as they conduct extensive and rigorous studies to assess our products and demonstrate that, compared with smoking, switching to smoke-free products will likely have a significant reduction in the risk of smoking-related disease. I take great pride in sharing and simplifying our complex scientific results into numbers and narratives that the public can better understand.

Can you tell us about your educational and professional journey?

I am a Canadian who studied in the U.S.—I earned my PhD in biometry and epidemiology from the Medical University of South Carolina. I now live in Switzerland with my family, since joining PMI in 2012. I lead a team of scientists who are engaging and sharing the science behind PMI’s smoke-free products to facilitate awareness and understanding of tobacco harm reduction and what it can mean for public health.

On my journey at PMI, I used to lead the Epidemiology and Biostatistics team within the department responsible for designing and conducting clinical and post-market assessment programs, and I have published numerous articles in international scientific journals.

What attracted you to work for PMI?

PMI is different from other companies. In my time here it has always been clear that science was at the core of where the company was headed and everything we do. In fact, PMI is the only major tobacco company that has made a public commitment to stop selling cigarettes and is actively pursuing that goal each and every day. This vision is a great source of motivation and inspiration for me in my work, but also within the organization as a whole.

I have always believed in the value of science—and being able to bring science to the forefront as everyone at PMI works to deliver on our smoke-free vision has kept me engaged and passionate about my work. In fact, I am even more passionate now than I was when I first joined the company. I would never have imagined more than 10 years ago when I started that I be in the role that I am in, or the importance of not just designing and conducting rigorous scientific research but also the need to actively engage and share that science with the external world. It is very gratifying to get to play my part in delivering a smoke-free future, a future without cigarettes—a future that I did not truly believe was possible when I started, but one that I now know is within our grasp and that I see us getting closer to everyday.

When I began, the goal was to develop and assess better alternatives to cigarettes; however, this quickly became a vision to phase out cigarettes altogether. And now, standing here in 2023 looking forward, we can see that the company is continuing to evolve beyond tobacco and nicotine as we grow into a health and wellness space.

How did PMI come up with the vision of A smoke-free future?

PMI’s smoke-free vision was developed over time based on public health calls for action, consumer need or demand, technological advancements, and business opportunity.

In 1997, the UN Focal Point on Tobacco or Health recommended that “in order to assist smokers who are so heavily dependent that they cannot possibly stop smoking, every effort should be made to reduce the toxicity of existing tobacco products.” The group requested that “the WHO … consider the above recommendations in future policy-development activities, including the drafting of a framework convention on tobacco control.”

Then, in 2003 the WHO Framework Convention on Tobacco Control (FCTC) included harm reduction in its framework document—Article 1d defined “tobacco control” as a range of supply, demand, and harm reduction strategies that aims to improve the health of a population by eliminating or reducing consumption of tobacco products and exposure to tobacco smoke.

In 2015, the WHO Study Group on Tobacco Product Regulation (TobReg) stated: “The main goals of comprehensive regulation of nicotine would be to minimize use of the most toxic nicotine-containing products, to encourage the development of new, improved nicotine delivery systems as alternatives to more toxic products, and to continue to monitor and regulate less toxic products for health effects.”

During this same time frame there was an electronics revolution with smaller and smaller circuitry, increased battery efficiency, and the introduction and mass uptake and transition of society to electronics and digital space. And when you couple that with the introduction of electronic cigarettes that—despite the limitations of some of the earlier products with satisfaction—was a clear demonstration that consumers were interested in and willing to switch to better alternatives.

PMI rose to the challenge and has been working to develop and scientifically assess less-harmful (less-toxic) alternatives to cigarettes that rely on electronics to heat the tobacco allowing the product to deliver a nicotine-containing aerosol without having to burn the tobacco and generate smoke. Since then, PMI has invested more than USD 10.5 billion to develop, scientifically substantiate, and commercialize innovative smoke-free products for adults who would otherwise continue to smoke. This commitment is the right thing to do for public health and society at large.

What is the science behind the smoke-free alternatives?

Most people know that smoking causes disease; therefore, we can all agree the best thing smokers can do for their health is to quit. But most of them will not, and that is why we need people to understand that the primary cause of smoking-related diseases are the toxic chemicals that are emitted in the smoke when the tobacco is burned.

Combustion—the burning of the tobacco—causes the release of high levels of harmful chemicals in the smoke. I know that lots of people think that it is the nicotine that is the problem, but nicotine, while addictive and not risk-free, is not the primary cause of smoking-related diseases. This is something that has been demonstrated over time and is now recognized by scientists and public health experts around the world.

We conduct extensive and rigorous scientific studies to assess the harms of switching to our smoke-free products compared with continued smoking, and—although long-term data will be needed to demonstrate and quantify the reduction in the risk of smoking-related disease—we see evidence that the improvements we do see will likely result in a significant risk reduction over time. Our research approach is inspired by well-recognized practices of the pharmaceutical industry and is in line with guidance from the U.S. Food and Drug Administration (FDA) for modified risk tobacco product (MRTP) applications. It includes laboratory research, clinical, and non-clinical studies when switching from smoking to smoke-free products, and research to understand the potential benefits of the product for the public health, including how smokers perceive the product’s risk and how they use the product in real-life conditions. We are now able to study actual use because we have products on the market in a number of countries.

What scientific research are you conducting?

Our assessment program covers a wide range of areas that vary depending on the product and where it is in development. Before products enter the market, the initial research is focused on testing the product design and controls, the emission of toxicants compared to cigarettes and laboratory assessment of the toxicity profile. Once this is complete, we work to assess the impact of these products at the user level and the impact of adult smokers switching to these products. This is done via clinical and behavioral research to understand the impacts of switching from cigarettes to smoke-free products. In the end, once a product is in the market, we monitor safety and study the actual use and impacts of these products in the real-world—i.e., we assess the impact at the population level.

Why should PMI’s science be trusted?

This is not a question of trust. We are conducting and sharing our science and the data with the scientific community, governments, and regulators so they can review the data and understand the science behind tobacco harm reduction and our smoke-free products. This allows us to learn because we are gathering feedback, addressing regulatory requirements, and sharing our science and results openly and transparently.

We publish our methodologies and scientific results. In fact, we have published more than 425 peer-reviewed publications and book chapters since 2008, and our scientists present the results of our research at scientific conferences and events and with regulators around the world. We have established a website (PMIScience.com) to publicly share the scientific research we have conducted to date. We invite dialogue and debate because science progresses when others can assess our findings.

We are increasingly seeing independent studies being conducted across the world, with over 100 studies and reports from government entities—such as the U.S. FDA, the UK Office of Health Improvement and Disparities (formerly Public Health England), the Dutch Federal Institute for Public Health, and Environment (RIVM), and the German Federal Institute for Risk Assessment (BfR)—confirming important elements of our research.

We are doing what we can to earn trust by operating transparently and responsibly.

Are Your heated tobacco products (IQOS) less harmful than cigarettes?/ How are they different from and better than cigarettes?

As a scientist, my answer is clearly: Yes.

IQOS is fundamentally different from a cigarette. The IQOS system heats the tobacco instead of burning it. This results in a significantly reduced production of harmful and potentially harmful chemicals. In fact, IQOS emits on average 95% lower levels of harmful chemicals than cigarettes. And in our clinical studies we have seen that smokers who switch completely from smoking to IQOS have a substantial reduction in exposure to these harmful chemicals (in fact, they achieve 95% reduced exposure as smokers who quit smoking for the duration of the study).

How do you respond to people who say that IQOS/HTps[A1]  generate “more toxins” than cigarettes?

This is simply incorrect. The scientific evidence shows that switching completely from cigarettes to IQOS significantly reduces the exposure to harmful or potentially harmful chemicals.

It is important that consumers and regulators alike receive accurate and non-misleading information based on science that allows them to make informed decisions. Therefore, we have invested heavily in R&D and dedicate substantial resources to openly sharing our research and data and engaging in the scientific debate and dialogue to grow the awareness and science knowledge on tobacco harm reduction and the role or contribution of smoke-free products.

As an example, we have performed more than 30,000 assessments of IQOS’s aerosol, which consistently demonstrate that the product emits on average 90% to 95% lower levels of harmful and potentially harmful chemicals (“HPHCs”) compared with cigarettes, depending on which list of HPHCs we compare to. This is independent of whether we perform the analysis at a PMI laboratory or independent accredited laboratories.

In science, the consistency and repeatability of the results add to the weight of the evidence.

Some other experts say IQOS emits toxic compounds that are not found in cigarettes and that, therefore, we do not know if it is really less harmful. How do you respond to that?

The IQOS aerosol is much less complex than cigarette smoke. IQOS emits significantly fewer (almost an order of magnitude fewer chemicals) and lower levels (on average 90% to 95% lower levels) of harmful chemicals than cigarettes. But there are a small number of chemicals in the IQOS aerosol that are unique or more abundant than in cigarette smoke. These compounds are generally not in the lists of harmful or potentially harmful chemicals established by health authorities for cigarette smoke.

The U.S. FDA concluded—based on their review of PMI data, available literature, and the results of their own testing of IQOS—that: “In particular, the agency determined the company demonstrated that because the IQOS Tobacco Heating System heats tobacco and does not burn it, it significantly reduces the production of harmful and potentially harmful chemicals compared to cigarette smoke. Furthermore, studies showed switching completely from combusted cigarettes to the IQOS Tobacco Heating System significantly reduces the body’s exposure to 15 specific harmful and potentially harmful chemicals. The toxicological assessment also found that, compared with cigarette smoke, IQOS aerosols contain considerably lower levels of potential carcinogens and toxic chemicals that can harm the respiratory or reproductive systems. Additionally, the FDA found that the applications supported the required consumer understanding findings.”[FDA press release]

How inclusive is PMI for the women scientists?

The number of women scientists at PMI is increasing year over year. Since I joined more than 10 years ago, I have seen a real change—not just to the number, but also in the advancement of the inclusion of women in scientific leadership roles and their visible contribution to the science. As an example, when I joined the clinical team in 2012, I was the only women in the clinical leadership team; now when I look at the team (even though I have moved on to a new role) I really see progress. I am so proud to be part of a company that puts such value on both inclusion and science—we are changing the face of science.

Do you believe there are enough women pursuing scientific careers today in the world?

We see progress—we are in a better place than we were a decade ago, but we are not there yet. We have a lot of work yet to do to narrow and eventually eliminate the imbalance.

The biggest impact of the current gender imbalance is that we are not harnessing the full potential of our scientific talent. Evidence shows that there is no difference in the quality of research conducted by men and women; therefore, we need to encourage more women to pursue their passions in the STEM (science, technology, engineering, and mathematics) fields to increase the quality of our science, drive innovation forward, and solve the biggest challenges humanity is facing.

How do you think women can be encouraged to develop an interest in science and then a career?

As a woman in science, I feel a great responsibility to be a positive role model, showing young women what is possible. We need to focus on better engaging with girls and young women who are students, when they are still searching for their purpose in life. This can take many forms—scholarships, internships, mentoring programs—anything that resonates and reaches young women, increasing their awareness and showing them that a career in science is something that is attainable to them.