January 1st, 2018 marked the date of the last possible submission to our Investigator Initiated Studies program (IIS). We interviewed Conny Johansson PhD, the manager of the program about the learnings of IIS on this occasion.
1. Could you describe the IIS program and your role in it?
Research from outside PMI is important to advance the global understanding of our smoke-free products and arrive at a more complete picture. Our Investigator Initiated Studies – IIS – program is a pilot program to encourage investigator-initiated research on our smoke-free products through financial, material or technical support. When we started the program, external research on PMI’s smoke-free products was very limited, because our products were not available in many markets and external funding for research on such products was limited. The intent behind the program was to help initiate external research. The program was established in June 2016, and in just a year and a half we have dedicated USD 10 million to support investigator initiated studies (through 2024).
On a day-to-day basis, we receive IIS proposals, for which I then organize PMI expert and multidisciplinary committee evaluations, provide feedback on the proposals and organize support for ongoing studies in accordance with our guidelines. What I like most about the program is the variety of exciting scientific proposals and the intensive collaboration with my colleagues in PMI’s Science and Innovation organization.
2. Why is the program closing?
I’m really excited to see a fast-growing number of independent studies on our smoke-free products – already over 20 of them. These are original, peer-reviewed scientific studies that are fully independent of PMI support. The last few were published just this year, as well as a couple of recent government reports from the US and the UK. These reviews cover the available scientific evidence on Platform 1 – both ours and independent research.
Most of the independent publications as well as the two government reports are in line with the conclusions from our assessment program, which is very encouraging for us.
Because of such independent studies, there is less need for our support to encourage new studies by external researchers.
The program stopped accepting new applications after January 1 this year, but we will of course continue to support the studies that are underway, progressing according to plan.
US Food & Drug Administration Tobacco Products Scientific Advisory Committee 2018 TPSAC Meeting Materials and Information
Public Health England Evidence review of e-cigarettes and heated tobacco products 2018: executive summary
"Most of the independent publications as well as the two government reports are in line with the conclusions from our assessment program, which is very encouraging for us."
5. Considering the fact that recent government reports are saying there is not enough independent research, how can you say there is less need for ongoing PMI support?
Although we do not conceive the research, have no operational oversight, no access to the data and do not review manuscripts for IIS studies, we know that studies which are completely independent can provide even stronger support for the conclusions we have reached in our own studies. For example, there are now several independent aerosol chemistry studies confirming our conclusions on the lower levels of harmful chemicals in Platform 1 aerosol compared to cigarette smoke (1, 2, 3, 4). I believe it is more of this kind of independent studies that recent government reports have been looking for. As with all research, it is essential that independent studies are well designed, use appropriate methods and that the results are interpreted fairly.
In order to reach a scientific consensus on the long-term effects of our smoke free products, I believe that the scientific community needs more studies. Personally, I would like to see more long-term studies focusing on product use behaviors as well as clinical and epidemiological studies – sponsored by PMI or independent.
I very much look forward to seeing what new independent studies may come out, each of them becoming a new piece of the scientific foundation on which a smoke-free future is built.
Li, X. et al. "Chemical Analysis and Simulated Pyrolysis of Tobacco Heating System 2.2 Compared to Conventional Cigarettes" Nicotine Tob. Res. DOI: 10.1093/ntr/nty005
"Comparison of Chemicals in Mainstream Smoke in Heat-not-burn Tobacco and Combustion Cigarettes." J. UOEH. DOI: 10.7888/juoeh.39.201
Veronese, C. et al. "Cigarette smoke, e-cig vapor and ‘heat-not-burn’: a comparison between the emissions of toxic compound." (in Italian) Tabaccologia. 1, 2017. pp 17-23.
Ruprecht, A.A. et al. 'Environmental pollution and emission factors of electronic cigarettes, heat-not-burn tobacco products, and conventional cigarettes." Aerosol Sci. Technol. DOI: 10.1080/02786826.2017.1300231
"As with all research, it is essential that independent studies are well designed, use appropriate methods and that the results are interpreted fairly."
"I very much look forward to seeing what new independent studies may come out, each of them becoming a new piece of the scientific foundation on which a smoke-free future is built."
3. How does this program compare to other investigator initiated programs?
Just as our assessment program is inspired by the pharmaceutical industry, so is our IIS program. Like pharmaceutical companies, we support investigator initiated studies that can expand the scientific knowledge on our products beyond our research. In both industries, external scientists submit research proposals for which they need support. Just like the pharmaceutical industry, we require investigators to follow the same standards and best practices applicable to their type of research, such as the principles of Good Clinical Practice in clinical studies, or the requirement for their protocols to be evaluated by an ethics committee.
Similarly to the pharmaceutical industry, we welcome external scrutiny. However, due to history, I think the level of scrutiny for studies supported by the tobacco industry is even higher than for the pharmaceutical industry. One way the IIS program addresses potential concerns is to ensure that our IIS investigators have full academic freedom. We require the investigators to submit the results of their studies to peer-reviewed scientific journals and we have absolutely no involvement in the manuscript writing or review process. In addition, we publicly disclose the projects we support on our website, including the amount of money or other type of support that is provided, all in the spirit of transparency.
Finally, one of the most important differences compared to the pharmaceutical industry is the investigational product. PMI’s smoke-free products are novel and designed for consumers. In the pharmaceutical industry, products are better known and designed for patients. There are many studies, standardized methods and abundant experience on how to investigate the effect of pharmaceutical products on patient populations, but we don’t yet have such a setup in smoke-free product research. I think these differences have made it more challenging for the investigators to develop proposals for research on our smoke-free products.
4. What research is being supported by the IIS program?
Currently, we have four ongoing studies. The one I’d like to highlight first is probably the first long-term health outcome investigation for Platform 1. The study is conducted by Dr. Sharman of the Academy of Preventive Medicine in Kazakhstan. This observational cohort study is following 400 Platform 1 users and 800 conventional cigarette smokers over 5 years to investigate if there is a difference in Chronic Obstructive Pulmonary Disease between the two groups. In addition, Dr. Sharman and his team have just initiated a proof of concept study, which may lead to the integration of mobile health devices to enrich the study data and explore new ways of how data can be captured in such studies.
"Similarly to the pharmaceutical industry, we welcome external scrutiny."
Another clinical study that is being conducted at the University of Catania will compare whether people who switch to either e-cigarettes or Platform 1 achieve similar abstinence from conventional cigarettes after 12 weeks. The investigators are preparing to start the study.
Researchers at the Technical University of Crete are investigating the leaching of chemicals of environmental concern from used heated tobacco sticks compared to conventional cigarettes.
Finally, Dr Kauneliene of University of Kaunas is studying the impact of Platform 1 on indoor air quality, expanding on our studies by investigating the impact in a “real-life setting” as well as under different use conditions. The research is progressing well and Dr Kauneliene expects to publish papers and conference posters in 2018.