Category: Science

Science exposed
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.
December 21, 2017
Japan’s vaping dilemma
Japan’s national government and the Tokyo metropolitan government are at odds about how to treat heat-not-burn (HNB) products as they consider, ahead of the 2020 Tokyo Olympics and Paralympics, regulations on public-places smoking and vaping, according to a Mainichi Daily News story.
HNB products are placed in the same category as combustible cigarettes under the Tobacco Business Act; so both were included in the original draft revision of the Health Promotion Act that the Ministry of Health, Labor and Welfare (MHLW) released in March.
The health ministry has said that it would consider excluding HNB products from legal regulation, but only if their vapor was proven scientifically to be harmless.
Given this, it is likely that HNB products will be treated in the same way as combustible cigarettes in the draft revision of the Health Promotion Act set to be submitted to the regular session of the Diet next year.
Meanwhile, Tokyo is aiming to establish its own ordinance on tobacco-related products, and its draft ordinance released in September explicitly stated that HNB products would be subject to regulation.
However, of the approximately 17,000 comments received from the public about the ordinance, about 2,000 called for HNB products to be excluded from the regulation, and a Tokyo government official has since expressed a more conciliatory stand than in September. “We are still undecided whether to rule out” HNB products from the restrictions, the official said.
Philip Morris Japan says that, compared with combustible cigarettes, its IQOS HNB device reduces, on average, about 90 percent of the toxic substances generated.
And Japan Tobacco says that HNB-device vapor does not affect the indoor environment, and that its risk should not be discussed in the same breath as that of combustible cigarettes.
But the Japanese Respiratory Society released a comment in October saying that as long as there was a possibility that HNB products had a negative impact on health, the use of such products was not recommended.
And Hiroshi Yamato, a professor at the University of Occupational and Environmental Health, Japan, said, “It is a rule of public health to regulate something when in doubt, and unless there is proof that it is harmless”.
December 19, 2017
FSFW calls for public input
The Foundation for a Smoke-Free World (FSFW) is launching two online processes designed to inform and guide the Foundation’s long-term research initiatives.
The first is a public comment period to solicit input on research priorities. The second is a call for letters of intent for early scoping grants that will help assess areas of research with the greatest potential to accelerate the end of smoking.
Researchers, policy makers, smokers and others with relevant experience or expertise are being invited to contribute.
“We encourage everyone with an interest in reducing death and disease from smoking to share informed opinions and creative suggestions on where we should focus our research efforts,” said Dr. Derek Yach, the founder and president of the FSFW.
“In particular, we are looking for new ideas, fresh thinking and innovative collaborations – expanding beyond the traditional tobacco control community – that will deliver dramatic and rapid progress toward a smoke-free world.”
In a press note issued on Tuesday, the FSFW said that since the Foundation’s formation in September, its leadership had been listening to and engaging with public health experts from around the world in a variety of forums, including conferences, one-on-one meetings and a Foundation-hosted research symposium.
‘Through these discussions and experiences, it became apparent that some potential areas of research exploration will need more detailed scoping and development before the Foundation issues large-scale requests for research proposals in 2018,’ the note said.
‘To prepare for the launch of an aggressive set of research programs in 2018, the Foundation is now accepting letters of intent for early scoping grants to gather more information on potential research topics related to smoking cessation, harm reduction and alternative livelihoods for tobacco farmers. ‘These grants are detailed on the Foundation’s website, www.smokefreeworld.org. Letters of intent are due Monday, December 11, and are the first step of an application process that will culminate with the awarding of initial scoping grants in January.’
In parallel, the Foundation is asking for public input on four questions to help determine its highest research priorities.
‘The questions are designed to identify areas of unmet need and potentially significant impact on smoking cessation, harm reduction, and alternative livelihoods for tobacco farmers,’ the note said. ‘The public can respond to the questions through the Foundation’s website until December 18. The questions will inform a draft version of the Foundation’s research agenda that will go online for public review in early 2018.’
December 1, 2017
Local studies needed
Indonesia needs more studies conducted by local researchers to reveal the impact of tobacco consumption on the nation’s health and health care costs, according to a story in The Jakarta Post citing an Antara News Agency report.
“We have often talked about the impact of tobacco use in the country, but we are just quoting information and data on the matter from reports by researchers in foreign countries,” said the Health Minister, Nila Moeloek.
Now that the National Health Insurance (JKN) program had been implemented in Indonesia, it was easier for researchers to conduct studies into the impact of tobacco consumption on public health and the healthcare costs involved in treating tobacco-related diseases, she said.
The Healthcare and Social Security Agency data had shown that 20-25 percent of JKN expenditure went to the treatment of non-communicable diseases related to tobacco consumption, such as cardiovascular diseases and lung cancer.
Nila said a study conducted by the Russian government found that the high incidence of tuberculosis in that country was related to alcohol and tobacco consumption.
“It’s probable that our researchers can conduct such a study given the high number of smokers in Indonesia,” she added.
November 24, 2017
No to shisha research
On the evidence of a survey launched in May, the board of CORESTA (Co-operation Centre for Scientific Research Relative to Tobacco) has decided not to include activities specific to water pipes in its work program.
The survey was conducted to evaluate interest in water pipe research since very little scientific work had been done on either water-pipe tobacco mixtures or emissions.
‘Work had started with ISO/TC 126 on a preliminary level in 2010 but was stopped in 2016 after four documents were drafted for proposed further projects,’ a CORESTA press note said.
‘The survey was announced in the CORESTA Newsletter (#47), on the website and via an e-mail to all CORESTA contacts.
‘It gathered 18 marks of interest, including four from non-CORESTA members. Sixteen had water pipe related activities, supplying material, equipment or services. Fourteen showed interest in future work but only nine declared having expertise in analytical methods, and 15 showed interest in participating in a workshop.
‘Considering the relatively low level of interest and the fact that work was simultaneously reactivated within ISO with four work item proposals for one ISO Standard and three Technical Specifications, the CORESTA Board eventually decided not to add water pipe specific activity within CORESTA’s work program.’
The following new ISO projects on water pipes were approved by ISO members at the end of May:
- ‘NP 22486 – Standard on definitions and standard conditions;
- ‘NP 22487 – Technical Specification on TPM and NFDPM;
- ‘NP 22492 – Technical Specification on CO in vapor phase;
- ‘NP 22991 – Technical Specification on CO in charcoal.’
November 14, 2017
FDA calls iQOS meeting
The US Food and Drug Administration has published a Federal Register notice announcing a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) to discuss modified risk tobacco product (MRTP) applications submitted by Philip Morris Products (PMP).
The meeting, which is scheduled for January 24-25 at the FDA’s White Oak campus, was the subject of a Center for Tobacco Products (CTP) press note.
The committee is due to discuss scientific issues related to the MRTP applications submitted by PMP for its iQOS system and several Marlboro HeatSticks products, which are currently under scientific review by the FDA.
Requests for the presentation of oral comments at the TPSAC meeting have to be submitted by December 27.
Written comments have to be submitted by January 4.
More information is available at: https://www.federalregister.gov/documents/2017/11/09/2017-24379/tobacco-products-scientific-advisory-committee-notice-of-meeting
November 9, 2017
Nicotine a ‘fascinating drug’
Vanderbilt University Medical Center (VUMC) is one of 29 sites participating in a US national study to determine whether a daily transdermal nicotine patch will have a positive effect on attention and early memory impairment in older adults diagnosed with Mild Cognitive Impairment (MCI), according to a medicalxpress.com story.
More than eight million people in the US are currently diagnosed with MCI, a condition that affects memory or other thinking skills. Recent evidence shows that adults with MCI are at a higher risk for subsequently developing Alzheimer’s disease.
MCI is diagnosed when memory problems become more apparent than would be expected in normal aging. Symptoms include memory loss, problems with attention, as well as mild difficulties learning and retaining new information.
People participating in the Memory Improvement Through Nicotine Dosing (MIND) study will participate in 12 visits over a two-year period at one of the 29 sites.
In an earlier study, adults with MCI who were prescribed the nicotine patch for six months had improved attention and memory, and there were no serious side effects or signs of nicotine withdrawal.
“These results were encouraging and justify this larger study, funded by the National Institute on Aging,” said VUMC’s Paul Newhouse, MD, Jim Turner professor of cognitive disorders and professor of psychiatry and behavioral sciences. Newhouse is the national director of the study.
“I am convinced that we will find a way to help improve early memory loss and make a real difference in people’s lives. In this study, we have an inexpensive, widely available potential treatment.”
Nicotine, a natural plant alkaloid, was a “fascinating drug with interesting properties,” Newhouse said. “People think of it as a potentially noxious substance, but it’s a plant-derived medication just like a lot of other medications.”
The medicalxpress.com story is at: https://medicalxpress.com/news/2017-11-explores-nicotine-patch-mild-cognitive.html.
November 8, 2017
PMI issues scientific update
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.
November 3, 2017
Can cigarette butts take off?
Chemists at the UK’s University of Nottingham have discovered that carbons derived from cigarette butts have ultra-high surface areas and unprecedented hydrogen storage capacity, which could solve a major waste disposal problem while offering a way to store clean fuel, according to a story on physorg.com relayed by the TMA.
Robert Mokaya, professor of materials chemistry, and Troy Scott Blankenship, an undergraduate project student, published their work in the academic journal Energy and Environmental Science.
“We have utilised cigarette butt waste as starting material to prepare energy materials that offer unprecedented hydrogen storage properties,” said Mokaya.
“This may not only address an intractable environmental pollution problem – cigarette butts – but also offers new insights into converting a major waste product into very attractive hydrogen storage materials.”
Using hydrogen as a fuel is appealing because the only by-product when combined with oxygen is water.
Mokaya said that this technique could be developed to replace, for example, gasoline as a transport fuel or natural gas as a heating fuel.
November 2, 2017
E-cig consultation launched
The Science and Technology Committee of the UK Parliament has launched a public consultation to ‘examine the impact of electronic cigarettes on human health (including their effectiveness as a stop-smoking tool), the suitability of regulations guiding their use, and the financial implications of a growing market on both business and the NHS’, according to a Bloomberg News story relayed by the TMA, and a report by Sarah Knapton for telegraph.co.uk.
The chair of the committee, Norman Lamb MP, said that almost three million people in the UK now used e-cigarettes, but that there were still significant gaps in the research guiding their regulation and sale.
“They are seen by some as valuable tools that will reduce the number of people smoking ‘conventional’ cigarettes, and seen by others as ‘re-normalising’ smoking for the younger generation,” Lamb said.
“We want to understand where the gaps are in the evidence base, the impact of the regulations, and the implications of this growing industry on NHS costs and the UK’s public finances.”
Written submissions will be accepted until December 8.
October 26, 2017