Independent Verification in Industry Data – Novel Products & Interventions

September 30, 2021

The panel of scientists involved in research on smoking, tobacco harm reduction (THR), e-cigarettes and other novel tobacco products discussed the topic of independent verification in industry data for novel products and interventions for smoking cessation and was coordinated by Professor Ignatios Ikonomidis, replacing Professor Demetrios Kouretas.

Professor Konstantinos Farsalinos who is involved in laboratory, clinical and epidemiological research on smoking, tobacco harm reduction (THR) and e-cigarettes initiated the discussion. The speaker discussed the importance of independent verification of data as a vital tool to understand THR products. Professor Farsalinos expressed his thoughts on how study replication is key for transparency, restricting prejudice, avoiding future mistakes of novel products and for research quality enhancement.

Professor Giovanni Li Volti, Chairman of CoEHAR at the University of Catania, expressed his views on the importance of replicating published studies in a manner that can enhance generalizability as it attempts to justify prior research confirming its validation and applicability. Professor Li Volti continued by saying replication is not data reproduction as we need to demonstrate that the initial hypothesis was correct by adding additional variables. Study replication is the continued progress of science to further understand hypothesis and the conclusions providing solid scientific data.

Professor Massimo Caruso then shared his viewpoints on the difficulty of replicating studies due to harmonization. The speaker discussed how at CoEHAR (Center of Excellence for the acceleration of HArm Reduction, University of Catania) they performed an experiment aiming to evaluate whether different cytotoxic and variability tests can be used with THR products concluding that Magnetic Particle Testing (MPT) is not good for testing cigarette smoke. Another study that they performed investigated nicotine dosimetry and stability in Cambridge filter PADs (CFPs) following different smoking regime protocols and storage conditions. Professor Caruso highlighted the difficulty to keep the controlled variables constant (e.g., exposure to cells) showing the difficulty of data replication.

Dr Ikonomidis asked the panellists their views on whether industry data and independent data are on the same trend or whether differences are observed. Professor Ikonomidis said that it is impossible for a replicated study to give the exact same results, however suggested that linear trends should confirm conclusions.

Next, Professor Farsalinos shared his experience with harmonization and standardization. The speaker highlighted that these are important during the experimental methodology stage. Professor Farsalinos continued by adding that the number of different equipment (battery, power settings, atomizers, liquids etc) to test THR products are not measurable as there are so many combinations making it difficult to standardize the collection methods. The speaker also pointed out several practical issues observed in published studies. For example, several publications ‘abuse’ power settings therefore producing bias results indicating the difficulties of study standardization.

Professor Li Volti added to the discussion the importance of always using new THR products during scientific experiments. The speaker gave an example that when you try to re-use and re-charge the same THR products, results may not be reliable stressing the importance of correctly testing vapour in the in vitro studies.

Professor Farsalinos further elaborated on the importance to do in vitro studies that have clinical relevance. For example, a good way would be to compare traditional tobacco cigarettes with the THR products through a comparative assessment using nicotine as a unit of exposure. The speaker highlighted that it is critical to work on experimental methodologies otherwise we will be obtaining meaningless data.

Professor Caruso agreed with Professor Li Volti and Professor Farsalinos and added the importance of eliminating contaminates from laboratory equipment (e.g., glass) that may create bias.

Dr Ikonomidis asked the professors two questions: the first, whether there are data or results that are borderline; the second, which experiments would they like to test in clinical settings.

Professor Li Volti responded that there is no doubt that the THR products decrease health damage. The speaker added that a 95% toxicity reduction was observed when using THR products. The speaker would be fascinated to see how the THR products would affect the central nervous system in clinical settings regarding addiction.

To the question which experiments he would like to test in a clinical setting, Professor Caruso replied that future work could investigate cohort naive vapourers who do not have any kind of pathologies.

Professor Farsalinos said that we need to shorten the clinical study time to obtain prognostic information. One way that we can do this is by working on people that already have an established disease as this will give us an idea what would happen if one switched to THR products from traditional cigarettes. Another way would be to find markers of disease (diagnostic indicators) or to measure exercise capacity (e.g., VO2 max).

Dr Ikonomidis concluded the panel discussion emphasising three key points. Firstly, the need for harmonization in methodological approaches stressing the importance of global documentation of the most recent and appropriate methods used in laboratories to analyse THR products. Secondly, that replicating studies follow similar trends in terms of toxicants and cytotoxicity, showing the beneficial effects of these products. Lastly, Dr Ikonomidis pointed out that future research should also include replicating and translating results from the laboratories to real-world clinical settings. This can be achieved using surrogate markers of lung and vascular functions comparing their effect to the tobacco combustible products.