October 22, 2018

Stanton A. Glantz, PhD

Tobacco Control publishes 22 papers on heated tobacco products, particularly IQOS, that challenge tobacco industry claims

Tobacco Control just published a special supplement on heated tobacco products, in particular PMI’s IQOS.  These papers use PMI’s own data as well as independent data to show that they are not as safe as PMI (and the other companies) claim.  You can download the whole issue here; a table of contents and links to each of the individual papers is at the bottom of this blog post.

Here is the UCSF press release on the issue, with emphasis on the UCSF authors:

Heated Tobacco Product Claims by Tobacco Industry Scrutinized by UC San Francisco Researchers and Others in Independent Data Review
Fourteen of 22 Papers Published in a Special Issue of Tobacco Control on Health, Marketing and Regulatory Aspects of New Tobacco Product Feature UCSF Authors

Claims by the tobacco industry that heated tobacco products (HTPs) are safer than conventional cigarettes are not supported by the industry’s own data and are likely to be misunderstood by consumers, according to research published in a special issue of Tobacco Control.

The issue was assembled by Stanton A. Glantz, PhD, director of the UCSF Center for Tobacco Control Research and Education

HTPs are aggressively promoted by the tobacco industry as less harmful than cigarettes because they heat tobacco rather than burn it to generate the aerosol that delivers nicotine to users’ lungs. The industry argument is that because HTPs do not set the tobacco on fire, they release lower levels of harmful chemicals and so cause less disease than conventional cigarettes.

The papers, published October 23, 2018, represent the first comprehensive collection of industry-independent peer-reviewed analyses of HTPs.

Many of the papers focus on IQOS, an HTP sold by Philip Morris International (PMI) in 30 countries including Canada, Israel, Italy and Japan. The U.S. Food and Drug Administration (FDA) has not yet approved IQOS for sale in the United States. In the issue’s introductory overview, Glantz noted that eight papers use data provided by PMI in its pending application to the FDA, while 12 provide independent assessments of IQOS and other HTPs, including their political and policy implications.

“Until now, most of the published research on HTPs had been done by tobacco companies,” said Glantz. “We’ve seen this charade from Big Tobacco before, going back to the 1960s, and the goal is always the same: to convince governments and the public that a new tobacco product is ‘safer,’ ‘cleaner’ or ‘less harmful’ than existing tobacco products. But in paper after paper, the scientists writing in this issue demonstrate that the health and other claims made for IQOS and other HTPs are false and misleading.” 

Overall, said Glantz, the issue’s contributors demonstrate that PMI’s safety claims for HTPs are not supported by the company’s own data, which further show that consumers are likely to misunderstand those claims. “While some impacts of IQOS may be lower than that of cigarettes, others may be as bad or worse,” he said. “The evidence does not support PMI’s broad claims of reduced harm.” He noted that researchers also found that HTPs are not as new as the industry would have consumers believe, with precursor devices going back decades. In addition, HTPs may appeal to young people. A final set of papers describes how HTPs fit into the tobacco industry’s global strategy to deal with increasing regulation worldwide; after a legal analysis, the authors conclude that the FDA should not allow IQOS to be sold in the U.S. 

UCSF scientists contributed to 14 of the 22 papers. Among them are:

Stella Bialous, RN, DrPH, FAAN, UCSF associate professor of social behavioral sciences, and Glantz identified the introduction of HTPs as the latest in a line of similar past efforts by the tobacco industry to undermine government regulation of tobacco by marketing a new product as “safer” or representing “harm reduction.” They called on governments to regulate HTPs as tobacco products or drugs, noting that tobacco companies are the “vector” for the tobacco epidemic and cannot be part of the global tobacco control solution.  

Glantz analyzed PMI’s publicly available data on biomarkers of potential harm and determined that there was no statistically detectable difference between IQOS and conventional cigarettes for 23 of 24 biomarkers of potential harm among American adult smokers, and no significant difference in 10 of 13 such biomarkers among Japanese adult smokers.

A team led by Jeffrey Gotts, MD, UCSF assistant professor of medicine, found that that HTPs could possibly cause some diseases not caused by conventional cigarettes. They identified animal and human studies in PMI’s FDA application suggesting that IQOS may cause liver toxicity not observed in cigarette users.  

Lauren Kass Lempert, JD, MPH, law and policy specialist, UCSF Center for Tobacco Control Research and Education, and Glantz wrote that the non-tobacco components of HTPs have escaped effective regulation in many countries because they are packaged and sold separately from the tobacco-containing components. Lempert and Glantz argued that in countries where IQOS is currently marketed, all components of HTPs should be regulated at least as stringently as other tobacco products. They also argued that because PMI has not submitted sufficient evidence that marketing IQOS in the United States would be “appropriate for the protection of the public health,” the standard companies must meet to market new tobacco products in the U.S., the FDA should not authorize sale of IQOS in the United States.  

A team led by UCSF professor of medicine Pamela Ling, MD, analyzed the marketing campaign for Accord, a failed HTP that was introduced by Philip Morris in the late 1990s and early 2000s. The researchers observed that unlike the Accord campaign, PMI seeks to market IQOS as having reduced health risk compared with cigarettes, even though it contains more nicotine and tar than Accord. The researchers attributed this shift in marketing claims to a looser social and regulatory environment rather than a significant improvement in the product’s aerosol chemistry.   

Another investigation led by Dr. Ling used previously secret tobacco industry documents to describe how R.J. Reynolds Tobacco Company quietly secured a 1991 editorial in The Lancet endorsing Premier, an earlier HTP, two years after Premier had been removed from the market. According to the authors, this historical case illustrates the importance of endorsements by respected health leaders and the need to insist on full disclosures of potential conflicts of interest. They noted that such endorsements are likely to play a critical role in determining the commercial fate of new HTPs, and may help the newest crop of modified tobacco products succeed where previous attempts have failed.

Wendy Max, PhD, UCSF professor of health economics and director of the Institute for Health & Aging in the UCSF School of Nursing, led a group that reviewed a computational model developed by PMI that compared the public health impact of cigarettes and HTPs on mortality from four diseases caused by smoking: lung cancer, ischemic heart disease, stroke and chronic obstructive pulmonary disease. PMI used results from the model as evidence for its claim that HTPs pose less health risk than cigarettes. The researchers found that the PMI model excludes morbidity, underestimates mortality, does not compare HTPs with any tobacco products other than cigarettes, does not include the potential of HTPs to initiate smoking among non-smokers and underestimates the health impacts of HTPs on nonsmokers. 

Farzad Moazed, MD, UCSF assistant professor of medicine, led a research group that studied publicly available data submitted by PMI to the FDA and determined that, among human smokers, both IQOS and conventional cigarettes were associated with significant toxicity in the lungs and immune system, with no detectable difference in toxicity between the two. Additionally, rats exposed to IQOS showed evidence of pulmonary inflammation.

A group led by Gideon St. Helen, PhD, UCSF assistant professor of medicine, reviewed PMI’s publicly available data comparing levels of 113 chemical constituents found in smoke from IQOS and conventional cigarettes. They found that 56 constituents were higher in smoke from IQOS, 22 were at least 200 percent higher and seven were at least a thousand percent higher. The potential harm that could be caused by these substances is unknown.

Matthew Springer, PhD, UCSF professor of medicine, led a team which showed that in rats, a single IQOS tobacco stick impaired the ability of arteries to become larger in response to increased blood flow to the same extent as smoke from a conventional cigarette. In addition, the team found that nicotine levels were about 4.5 times higher in rats after exposure to IQOS compared with cigarettes. 

The papers from other institutions provided insights into how IQOS is being marketed in other countries, how users would misunderstand marketing claims, and adverse health effects of HTPs.

While the issue was assembled by Glantz, all the papers were independently peer-reviewed by outside editors selected by Tobacco Control.

“When it comes to regulating tobacco, governments, regulatory bodies and nonprofit agencies need to always keep in mind that the tobacco industry is the source of the problem and can never be part of the solution,” said Glantz. “Tobacco companies exist to sell tobacco to as many consumers as possible, period. Partnering with them to control tobacco use or promote harm reduction is always going to be a losing strategy.”  

For more information visit:
UCSF Center for Tobacco Control Research and Education https://www.tobacco.ucsf.edu/.
UCSF Tobacco Centers of Regulatory Science https://tobacco.ucsf.edu/tobacco-centers-regulatory-science.  
Tobacco Centers of Regulatory Science http://prevention.nih.gov/tobacco/tcors/aspx
  
All of the papers are available for free at 
https://tobaccocontrol.bmj.com/content/27/Suppl_1.

Funding: The papers were funded by numerous agencies and foundations, including the U.S. National Cancer Institute, Food and Drug Administration Center for Tobacco Products, and the National Heart, Lung, and Blood Institute at the National Institutes of Health. Full funding information can be found on each paper. 

Here are summaries of the other papers in the special issue that are from outside UCSF:

Irina Stepanov and Alistair Woodward, the outside editors who managed the peer review for all the papers, put the special issue in the larger context of HTP research. They close with a question and answer:  “Will the industry attempt to maintain their diverse consumer base by whatever means available? The most likely answer is yes, because this is what it takes to stay in the business of tobacco.”

Maciej Goniewicz and his colleagues at Roswell Park did original experiments on the cytotoxic effects of IQOS on human lung cells and compared the results to Philip Morris Marlboro cigarettes and Mark Ten e-cigarettes.  They found that the IQOS was more toxic than clean air and the e-cigarette, but less toxic than the Marlboro.  In another paper, they measured carcinogenic tobacco specific nitrosamines (TSNA) in the aerosol, and found that Like combustible products, IQOS emit substantial levels of TSNA. The levels are lower than combustible cigarettes and significantly higher than from e-cigarettes.

Bonnie Halpern Felsher and colleagues (including some from UCSF) reviewed the data in PMI’s IQOS application to the FDA and concluded it is likely appeal to adolescents and young adults. In another paper, they concluded that consumers will not understand the “switch completely” condition used in PMI’s advertising claims for IQOS — that they must quit using cigarettes completely to achieve the inferred health benefits of IQOS. Rather, they are likely to misunderstand the unsupported claims of reduced risks to mean IQOS are harm-free.

Lucy Popova from Georgia State University, collaborating with people at UCSF, assessed the data in PMI’s application to FDA and concluded that the data in the PMI’s application do not support reduced risk claims and the reduced exposure claims are perceived as reduced risk claims, which is explicitly prohibited by the FDA. Allowing PMI to promote IQOS as reduced exposure would amount to a legally sanctioned repeat of the ’light’ and ’mild’ fraud which, for conventional cigarettes, is prohibited by the US law and the WHO Framework Convention on Tobacco Control.

Noel Brewer and colleagues from UNC and NIH conducted a national survey and found that risk and exposure claims made for HTP acted similarly on beliefs. Lower exposure claims misled the public to perceive lower perceived risk even though no lower risk claim was explicitly made, which is impermissible under US law.  (This result is an independent confirmation of Halpern-Felsher et al’s and Popova et al’s interpretation of the data PMI submitted to FDA on IQOS.)

Michael Eriksen and colleagues at Georgia State University reported original data from a national study they conducted and found that awareness of HTP products is increasing in the US even though they are not yet approved for sale in the US, especially among men and younger adults and may be being used disproportionately by racial/ethnic minorities.

Elizabeth Hair and colleagues at Truth Initiative report marketing research they conducted in Japan and Switzerland, where IQOS is being sold, and found that IQOS was marketed as a sophisticated, high tech and aspirational product. Because youth and young adults are more interested in such product positioning, this approach raises some concern about youth appeal, although these effects may vary from country to country.

Jinyoung Kim and colleagues from several Korean institutions, conducted a national survey and found that current IQOS users were more likely to smoke conventional cigarettes and/or e-cigarettes, which contradicts the tobacco industry’s claims that conventional cigarette smokers will switch to heated tobacco products.

Laura Rosen and Shira Kislev from Israel describe how PMI has taken advantage of a weak regulator environment to roll IQOS out, as well as some successful pushback from health forces.

Here is the table of contents for the whole issue with links to the papers.  You can download the whole issue in one PDF here

  Heated tobacco products: the example of IQOS

  Stanton A Glantz

  Tob Control 2018; 27:s1-s6, doi:10.1136/tobaccocontrol-2018-054601

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s1.extract?etoc

 

  Heated tobacco products: things we do and do not know

  Irina Stepanov, Alistair Woodward

  Tob Control 2018; 27:s7-s8, doi:10.1136/tobaccocontrol-2018-054774

http://tobaccocontrol.bmj.com/content/27/Suppl_1/s7.extract?etoc

 

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 Research papers

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  PMI’s own in vivo clinical data on biomarkers of potential harm in Americans show that IQOS is not detectably different from conventional  cigarettes

  Stanton A Glantz

  Tob Control 2018; 27:s9-s12 Published Online First: 21 Aug 2018 ,

  doi:10.1136/tobaccocontrol-2018-054413

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s9.abstract?etoc

 

  Vascular endothelial function is impaired by aerosol from a single IQOS HeatStick to the same extent as by cigarette smoke

  Pooneh Nabavizadeh, Jiangtao Liu, Christopher M Havel, Sharina Ibrahim, Ronak Derakhshandeh, Peyton Jacob III, Matthew L Springer

  Tob Control 2018; 27:s13-s19 Published Online First: 11 Sep 2018 ,

  doi:10.1136/tobaccocontrol-2018-054325

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s13.abstract?etoc

 

  Assessment of industry data on pulmonary and immunosuppressive effects of IQOS

  Farzad Moazed, Lauren Chun, Michael A Matthay, Carolyn S Calfee, Jeffrey Gotts

  Tob Control 2018; 27:s20-s25 Published Online First: 29 Aug 2018 ,

  doi:10.1136/tobaccocontrol-2018-054296

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s20.abstract?etoc

 

  IQOS: examination of Philip Morris International’s claim of reduced exposure

  Gideon St.Helen, Peyton Jacob III, Natalie Nardone, Neal L Benowitz

  Tob Control 2018; 27:s30-s36 Published Online First: 29 Aug 2018 ,

  doi:10.1136/tobaccocontrol-2018-054321

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s30.abstract?etoc

 

  Heated tobacco products likely appeal to adolescents and young adults

  Karma McKelvey, Lucy Popova, Minji Kim, Benjamin W Chaffee, Maya  Vijayaraghavan, Pamela Ling, Bonnie Halpern-Felsher

  Tob Control 2018; 27:s41-s47, doi:10.1136/tobaccocontrol-2018-054596

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s41.abstract?etoc

 

  IQOS labelling will mislead consumers

  Karma McKelvey, Lucy Popova, Minji Kim, Lauren Kass Lempert, Benjamin W Chaffee, Maya Vijayaraghavan, Pamela Ling, Bonnie Halpern-Felsher

  Tob Control 2018; 27:s48-s54 Published Online First: 29 Aug 2018 ,

  doi:10.1136/tobaccocontrol-2018-054333

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s48.abstract?etoc

 

  Awareness and use of heated tobacco products among US adults, 2016–2017

  Amy L Nyman, Scott R Weaver, Lucy Popova, Terry Frank Pechacek, Jidong Huang, David L Ashley, Michael P Eriksen

  Tob Control 2018; 27:s55-s61 Published Online First: 29 Aug 2018 ,

  doi:10.1136/tobaccocontrol-2018-054323

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s55.abstract?etoc

 

  Impact of modified risk tobacco product claims on beliefs of US adults and adolescents

  Sherine El-Toukhy, Sabeeh A Baig, Michelle Jeong, M Justin Byron, Kurt M  Ribisl, Noel T Brewer

  Tob Control 2018; 27:s62-s69 Published Online First: 29 Aug 2018 ,

  doi:10.1136/tobaccocontrol-2018-054315

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s62.abstract?etoc

 

  Examining perceptions about IQOS heated tobacco product: consumer studies in Japan and Switzerland

  Elizabeth C Hair, Morgane Bennett, Emily Sheen, Jennifer Cantrell, Jodie Briggs, Zoe Fenn, Jeffrey G Willett, Donna Vallone

  Tob Control 2018; 27:s70-s73 Published Online First: 15 May 2018 ,

  doi:10.1136/tobaccocontrol-2018-054322

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s70.abstract?etoc

 

  Modelling the impact of a new tobacco product: review of Philip Morris International’s Population Health Impact Model as applied to the IQOS heated tobacco product

  Wendy B Max, Hai-Yen Sung, James Lightwood, Yingning Wang, Tingting Yao

  Tob Control 2018; 27:s82-s86 Published Online First: 1 Oct 2018 ,

  doi:10.1136/tobaccocontrol-2018-054572

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s82.abstract?etoc

 

  Light and mild redux: heated tobacco products’ reduced exposure claims are likely to be misunderstood as reduced risk claims

  Lucy Popova, Lauren Kass Lempert, Stanton A Glantz

  Tob Control 2018; 27:s87-s95 Published Online First: 12 Sep 2018 ,

  doi:10.1136/tobaccocontrol-2018-054324

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s87.abstract?etoc

 

  Invisible smoke: third-party endorsement and the resurrection of heat-not-burn tobacco products

  Jesse Elias, Pamela M Ling

  Tob Control 2018; 27:s96-s101 Published Online First: 6 Jun 2018 ,

  doi:10.1136/tobaccocontrol-2018-054433

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s96.abstract?etoc

 

  Revolution or redux? Assessing IQOS through a precursor product 

Jesse Elias, Lauren M Dutra, Gideon St. Helen, Pamela M Ling

  Tob Control 2018; 27:s102-s110 Published Online First: 10 Oct 2018 ,

  doi:10.1136/tobaccocontrol-2018-054327

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s102.abstract?etoc

 

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 Brief reports

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  Cytotoxic effects of heated tobacco products (HTP) on human bronchial epithelial cells

  Noel J Leigh, Phillip L Tran, Richard J O’Connor, Maciej Lukasz Goniewicz

  Tob Control 2018; 27:s26-s29 Published Online First: 5 Sep 2018 ,

  doi:10.1136/tobaccocontrol-2018-054317

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s26.abstract?etoc

 

  Awareness, experience and prevalence of heated tobacco product, IQOS, among young Korean adults

  Jinyoung Kim, Hyunjae Yu, Sungkyu Lee, Yu-Jin Paek

  Tob Control 2018; 27:s74-s77 Published Online First: 29 Aug 2018 ,

  doi:10.1136/tobaccocontrol-2018-054390

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s74.abstract?etoc

 

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 Research letters

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  Tobacco-specific nitrosamines (TSNA) in heated tobacco product IQOS

  Noel J Leigh, Mary N Palumbo, Anthony M Marino, Richard J O’Connor, Maciej Lukasz Goniewicz

  Tob Control 2018; 27:s37-s38 Published Online First: 21 Sep 2018 ,

  doi:10.1136/tobaccocontrol-2018-054318

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s37.extract?etoc

 

  Possible hepatotoxicity of IQOS

  Lauren Chun, Farzad Moazed, Michael Matthay, Carolyn Calfee, Jeffrey Gotts

  Tob Control 2018; 27:s39-s40 Published Online First: 21 Aug 2018 ,

  doi:10.1136/tobaccocontrol-2018-054320

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s39.extract?etoc

 

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 Industry watch

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  IQOS campaign in Israel

  Laura J Rosen, Shira Kislev

  Tob Control 2018; 27:s78-s81 Published Online First: 19 Oct 2018 ,

  doi:10.1136/tobaccocontrol-2018-054619

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s78.extract?etoc

 

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 Special communication

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  Heated tobacco products: another tobacco industry global strategy to slow progress in tobacco control

  Stella A Bialous, Stanton A Glantz

  Tob Control 2018; 27:s111-s117 Published Online First: 12 Sep 2018 ,

  doi:10.1136/tobaccocontrol-2018-054340

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s111.abstract?etoc

 

  Heated tobacco product regulation under US law and the FCTC

  Lauren Kass Lempert, Stanton A Glantz

  Tob Control 2018; 27:s118-s125 Published Online First: 5 Oct 2018 ,

  doi:10.1136/tobaccocontrol-2018-054560

  http://tobaccocontrol.bmj.com/content/27/Suppl_1/s118.abstract?etoc

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