Tag: Switzerland

New data presented at the Society of Toxicology Annual Meeting (SOT) have demonstrated the potential risk reduction offered by switching from conventional cigarettes to two different heat-not-burn tobacco products and e-cigarettes.
A PMI Science press note issued on Wednesday said that a range of studies had investigated the toxicological impact of Philip Morris International’s Tobacco Heating System 2.2 (THS 2.2), Carbon Heated Tobacco Product 1.2 (CHTP 1.2) and prototype e-cigarette products in the context of respiratory disease, cardiovascular disease, and lung cancer using several different approaches. In each case, the aerosols produced by the alternative products were said to have resulted in significantly reduced levels of biological impact as compared to cigarette smoke (CS).
‘One six-month, multi-arm exposure study compared the effects of CS with those of the aerosol from the two heat-not-burn tobacco products THS 2.2 and CHTP 1.2 using a mouse model,’ the note said. ‘In both THS 2.2 and CHTP 1.2, tobacco is heated rather than burned, resulting in significantly reduced levels of harmful chemicals emitted and inhaled as compared with CS,’ the note said.
‘Through a systems toxicology approach, combining physiological, histological, and omics [various biology disciplines] endpoints, the study found that exposure to THS 2.2 and CHTP 1.2 aerosols had minimal adverse respiratory and cardiovascular effects in comparison to exposure to CS. The findings are in line with a previous assessment of THS 2.2, demonstrating reproducibility of the results obtained. In addition, both cessation and switching to CHTP 1.2 aerosol exposure after three months exposure to CS reversed inflammatory lung responses, halted the progression of aortic plaque growth and reduced the perturbations of biological pathways in heart tissue, to levels typically seen following exposure to fresh air alone.’
PMI Science said that another study presented at SOT had assessed lung inflammation, emphysema and the underlying molecular changes typically associated with lung cancer following up to 18 months of exposure to either CS or THS 2.2 aerosol. ‘The study used a combination of traditional toxicology endpoints as well as systems toxicology techniques including histological, transcriptomic, and proteomic analysis of the lungs,’ the note said. ‘In all endpoints, the biological impact of THS 2.2 aerosol was significantly lower than that of CS.’
Meanwhile, the company said that, in line with the principles of 21^st century toxicology, PMI was developing also novel in vitro methods for toxicity testing using human cells. ‘Such models have the potential to reduce the necessity for animal testing and offer more cost-efficient and timely results, as well as a detailed understanding of the biological processes underlying toxicity,’ it said.
‘In collaboration with the Institute for In Vitro Sciences (IIVS), one study presented at the SOT evaluated the performance and reproducibility of three new in vitro assays. Six laboratories conducted comparison of the assays and found that these non-animal test systems may provide consistent human-relevant data corresponding to key events involved in respiratory disease. A further in vitro methodology using human bronchial epithelial cells was used in a study assessing the effects of THS 2.2 aerosol and CS.^’
“The multi-lab comparison of these non-animal systems paves the way for more robust and meaningful strategies for toxicity testing,” said Dr. Holger Behrsing, principal scientist, IIVS. “They allow us to generate human-relevant data that will be of interest not just to industry and research scientists, but also to regulatory bodies. In order to develop these assays and ensure they reach their fullest potential, collaboration is key. Working with PMI and a range of different laboratories has allowed us to leverage expertise across the field and demonstrate the reproducibility of our findings. In the spirit of open science, we hope that this will open the door to further collaborations in the investigation, development, and validation of novel in vitro systems.”
In the assessment of three prototype e-cigarettes, biological changes following three-week’s exposure to the either the e-cigarette aerosols or CS were assessed using traditional and systems toxicology endpoints. CS exposure was found to induce biological responses associated with smoking-related diseases in the respiratory tract, while e-cigarette aerosol exposures, even at higher levels of nicotine delivery, resulted in substantially reduced molecular and microscopic changes. Two additional e-cigarette studies assessed the biological effects of flavor compounds typically added to e-cigarette liquids, demonstrating the potential to establish a scientifically substantiated list of minimally-toxic flavor ingredients.
PMI said it was leading a full-scale effort to ensure that heat-not-burn tobacco products and e-cigarettes ultimately replaced cigarettes.
Further information on PMI’s Reduced-Risk Product development and assessment program can be found at www.pmiscience.com.

Four scientists and researchers who worked for Philip Morris International on its iQOS program have told Reuters that while the company was able to prove that this device reduced the exposure of users to harmful substances from the exposure associated with combustible cigarettes, that didn’t necessarily mean that using the device was less likely to result in disease.

The Reuters piece, by Paritosh Bansal, Tom Lasseter, Duff Wilson and Aditya Kalra, Philip Morris’ search for a cigarette no more harmful than a cup of coffee, is at: https://www.reuters.com/article/us-tobacco-iqos-science-risk/philip-morris-search-for-a-cigarette-no-more-harmful-than-a-cup-of-coffee-idUSKBN1EE1GQ.

“Exposure is not directly linked to the risk of having a disease,” said Hans-Joerg Urban, who is said to have joined PMI’s research headquarters as a scientist in 2005 and worked at PMI until 2010 analyzing data from clinical and laboratory experiments. “The diseases are much too complicated.”

Dorothy Hatsukami, a former member of the US Food and Drug Administration’s tobacco products scientific advisory committee, agreed. “At this point, research is still too nascent to say with certainty that reduced exposure translates into reduced risk,” she said.

PMI is seeking FDA approval to market iQOS under two different standards. It has applied for approval as a device that reduces exposure to harmful substances. And it has applied on a second track with a higher bar – to get approval to market it as carrying reduced risk of tobacco-related disease.

The first option, a special provision for companies that are unable to meet the threshold of reduced risk, comes with a restriction. Consumers cannot be ‘misled into believing’ the product is less harmful than other tobacco products, FDA regulations say.

The Reuters piece reported that PMI said the lack of combustion in the case of iQOS meant vapers were exposed to far lower levels of toxic emissions than were the smokers of combustible cigarettes.

‘The ultimate result of this is reduced tobacco related harm and diseases,’ Reuters quoted the company as saying in a statement.

Meanwhile, a longer Reuters piece, by Tom Lasseter, Paritosh Bansal, Thomas Wilson, Ami Miyazaki, Duff Wilson and Aditya Kalra, reports how scientists describe what they see as problems in PMI’s experimental methods.

It is at: https://www.reuters.com/article/us-tobacco-iqos-science-risk/philip-morris-search-for-a-cigarette-no-more-harmful-than-a-cup-of-coffee-idUSKBN1EE1GQ.

The latest issue of Philip Morris International’s Scientific Update for Smoke-Free Products focuses on PMI’s scientific assessment program as it applies to its Electronically Heated Tobacco Product (EHTP).

In a press note yesterday announcing the publication of the update, Professor Manuel Peitsch, PMI’s chief scientific officer was quoted as saying that the company had developed a truly world class R&D program to assess scientifically the potential of its smoke-free products to reduce risk.

“With each progressive step of our assessment of EHTP, we have seen a significant reduction in exposure to a number of harmful chemicals and risk potential compared with cigarettes,” he said.

“Because transparency is a vital part of our program, we are making our evidence available for others to review.”

The note said the focus was on PMI’s scientific assessment program as it applied to its EHTP, referred to in the literature as the tobacco heating system (THS).

‘PMI established its multi-step assessment program applying internationally accepted scientific and quality standards along the same principles as the US Food and Drug Administration (FDA) draft guidance (2012),’ the note said.

‘The feature article outlines each step of the assessment program and summarizes key results of supporting data. Included is an overview of the more than 30 EHTP-related studies. PMI submitted this evidence to the FDA in the form of a modified risk tobacco product (MRTP) application.

‘Beyond the MRTP-related content, the Scientific Update provides an overview of the assessment to date on its smoke-free product portfolio. The issue also covers key presentations at scientific conferences. It is an important complement to PMI’s ongoing efforts to share its latest science, which include a dedicated website…

‘PMI’s extensive research and assessment program is inspired by the well-recognized practices of the pharmaceutical industry and in line with guidance of the US FDA for MRTPs. The Company today employs over 400 world-class scientists, engineers and experts who conduct rigorous research, including laboratory and clinical studies, as well as ground-breaking systems toxicology. The assessment program also includes studies on actual product use and correct understanding of product communications, as well as post-market research.’

The update is at: https://www.pmiscience.com/system/files/publications/pmi_scientific_update_november_2017.pdf.