Riccardo Polosa

Professor Riccardo Polosa is a tobacco harm reduction advocate and has been described as one of the “most prolific” academic authors in the area of e-cigarettes.¹ He has lobbied governments in favour of less restrictive regulation for potentially reduced risk products and has a history of collaborating with tobacco companies.

Background

Polosa is the Director of the Institute of Internal and Emergency Medicine and the School of Specialization in Rheumatology of the University of Catania in Italy. In March 2018 he founded the Center of Excellence for the Acceleration of Harm Reduction (CoEHAR), an interdepartmental Research Centre within the University of Catania.²³ This has received significant funding from a tobacco-industry front group, the Foundation for a Smoke-Free World (see below for more).

Polosa works in the field of clinical bronchoprovocation (airway-challenge studies) and has authored more than 300 peer reviewed articles mainly covering respiratory medicine, clinical immunology, and tobacco addiction.⁴ In 2014 a fellow researcher dubbed Polosa the “most prolific” academic author in the field of e-cigarettes.

After many years as President of the Italian Anti-Smoking League, LIAF (Lega Italiana Anti Fumo), Polosa now serves as LIAF’s Chief Scientific Advisor.⁵ He is also a Special Scientific Advisor to the International Network of Nicotine Consumer Organizations (INNCO).⁶ The INNCO was formed in 2016 and represents organisations promoting newer nicotine and tobacco products such as e-cigarettes (also known as electronic nicotine delivery systems, or ENDS), heated tobacco products and snus. It describes itself as “the collective voice for the most influential nicotine consumer organisations in twenty seven nicotine consumer organisations in twenty five countries across five continents who each recognise that there are safer ways to enjoy nicotine consumption than tobacco smoking”.⁷ In November 2018 INNCO was granted $100,300 from the Foundation for a Smoke-Free World to strengthen “nicotine consumer organizations”.

Moreover, since 2019 Polosa has served on the Medical and Scientific Advisory Board (MSAB) of PharmaCielo, a Canadian company which manufactures and sells medicinal grade cannabis oil.⁸ The MSAB is led by Delon Human.

According to a statement from Polosa written in 2020, he serves pro bono as the Chair of the European Technical Committee for standardization on Requirements and test methods for emissions of electronic cigarettes (CEN/TC 437; WG4).⁹

In December 2023 The Times newspaper published an article that described how Riccardo Polosa’s research was used to help promote e-cigarettes in the UK.¹⁰

Direct and Indirect Relationships with the Tobacco Industry

Research Funded by Juul Labs, Inc. (2020)

In October, 2020 Polosa was listed as the scientific director on a paper disseminated on the pre-print platform medrxiv. The paper (a pre-print i.e. an unpublished, non-peer-reviewed research article) detailed the research protocol for a multicentre trial – the GENESIS trial – investigating the effects of switching to different e-cigarettes in smokers with schizophrenia spectrum disorders.¹¹ The research declared it was ‘supported by an Investigator-Initiated Study award by JUUL Labs Inc. (Juul Science Programme)’.

The trial was registered on the clinicaltrials.gov website in June 2020 and is estimated to run until June 2022.¹²

CoEHAR Funded by Foundation for a Smoke-Free World (2018-2021)

Between 2018 and 2019, Polosa’s CoEHAR was given grants totalling $8,242,298 from the Foundation for a Smoke-Free World (FSFW), an ostensibly independent scientific organisation aimed at ‘accelerating the end of smoking’ which is solely funded by Philip Morris International (PMI). According to FSFW’s 2019 tax return, it has also approved another $22,928,186 in grant funds for CoEHAR.¹³

FSFW plans to fund CoEHAR until at least March 2024, according to its website.¹⁴

Consulted for British American Tobacco (2018)

After giving oral evidence at the UK Parliamentary Science and Technology Committee hearing into e-cigarettes on 9 January 2018, Polosa wrote a letter to the Committee dated February 2018.¹⁵ In this letter Polosa confirmed that he was working for Swiss-based consultancy firm Health Diplomats, a company founded by Delon Human and which he described as providing “…harm minimisation solutions to the alcohol, food & beverage, pharmaceutical, tobacco and nicotine industries”.¹⁶ In particular, Polosa said he was the “Medical Contact” in “3 BAT-funded clinical trials in respect of its e-cigarette and tobacco heating devices and their potential for harm reduction”. He described his role as helping “with the design of the clinical research protocol, to provide guidance on any medial and safety issues related to study participants, and to oversee with the analysis and interpretation of clinical trial data and the reporting of clinical trial results”.

While Polosa has declared this previous funding from Health Diplomats in conflict of interest statements of research papers, he often does not declare that this work involved the above research assistance to BAT.¹⁷¹⁸¹⁹

Harm Reduction Research Funded by Philip Morris International (2017/18)

In 2017 Polosa was awarded €968,708.00 from Philip Morris Products SA, a subsidiary of Philip Morris International (PMI) for “A 12-weeks open label, non-inferiority trial comparing HnB not Burn products vs ECs e-cigarettes in terms of efficacy and adoption rates, acceptability, tolerability, and tobacco harm reduction in healthy smokers, not motivated to quit”.²⁰²¹

The trial was originally scheduled to commence on 20 December 2017, but records from the U.S. National Library of Medicine, which houses a clinical trials registry, show that its actual estimated start date was 18 July 2018 with an expected completion date of 18 July 2019.²² Records show that the actual study start date was 25 May 2019 and the actual completion date was 25 May 2020.²³ In March 2018 PMI consented to a request to change the study’s Principal Investigator from Polosa to Dr Enrico Mondati, Polosa’s departmental colleague at the University of Catania and fellow member of CoEHAR’s Founders Council.²⁴

In January 2020, Polosa was listed as author on a research paper which outlined the study protocol for the above clinical trial.  The authors declare the research was ‘supported by an Investigator-Initiated Study award by Philip Morris Products SA’. The paper states Polosa was one of the authors ‘responsible for designing the study protocol’.²⁵

Collaborated with Tobacco Industry Scientists (2017/18)

In September 2017, Polosa took part in a symposium titled “Approaches for the assessment of next generation products” at the 53rd Congress of the European Societies of Toxicology (‘EuroTox 2017’) held in Slovakia.²⁶

Polosa presented on “Tobacco harm reduction and e-cigarettes” and fellow symposium presenters included tobacco industry representatives Manuel Peitsch (PMI’s Chief Science Officer), Chris Proctor (BAT’s Chief Science Officer), and Thord Hassler (Vice President Research and Development Swedish Match). In a paper published in May 2018, first author Peitsch and co-authors Polosa and others summarised the symposium presentations and further promoted the use of newer products in a tobacco harm reduction approach to health regulation.²⁷ The article explicitly states that “Riccardo Polosa’s research in harm reduction has not been supported by the tobacco industry”. Yet, as we have seen above, only months prior to publication, Polosa was awarded close to €1 million by PMI for a 12 week trial to assess heated tobacco products and e-cigarettes.

Research Funded by Philip Morris USA (2003-2005)

In April 2004, a LIAF press release announced that its President, Polosa, and Philip Morris USA (PM) were to jointly develop a research project on nicotine addiction. Internal tobacco industry documents show that Polosa applied to PM’s External Research Program in August 2002, requesting US$ 281,080 for a research study titled “Cigarette smoke and endothelial/platelet activation: Evaluation of prothrombotic markers during smoke cessation”.²⁸ The budget was to cover 20% of Polosa’s time as the study’s Principal Investigator, amounting to US$ 19,900 over two years, and would further fund one research technician post and co-fund a fellowship (see Image 1).

The PM grant ran from 1 May 2003 to 30 April 2005,²⁹ and a signed agreement between PM and the University of Catania confirms Polosa’s key role in the project, deeming his services as “essential to the research being performed”.³⁰

Another internal PM document suggests the company eventually awarded Polosa and his team a total of US$ 316,060; US$ 189,575 in the first year, and US$ 125,485 in the second.³¹ Under the terms of the agreement, Polosa and colleagues were required to acknowledge PM funding in all papers published resulting from this work.

Invited Speaker at Events

In 2015, 2017 and 2018 Polosa was an invited speaker at the Global Tobacco and Nicotine Forum, an annual tobacco industry event previously known as the Global Tobacco Networking Forum.³²³³³⁴ See also the following pages:

• Global Tobacco and Nicotine Forum 2018
• Global Tobacco and Nicotine Forum 2017
• Global Tobacco and Nicotine Forum 2015

In 2020 and 2019, Polosa was an invited speaker at the Global Forum on Nicotine, an event which has provided a platform for the tobacco industry and others to promote tobacco harm reduction.³⁵³⁶

Conflict of Interests: Lack of Transparency

Polosa’s conflict of interest statements have been inconsistent, and in general he has been more transparent about his links with the e-cigarette and pharmaceutical industries, than about his links with the tobacco industry.

In a letter to the UK parliament in February 2018, while disclosing his links to the e-cigarette company Arbi Group Srl, the UK Electronic Cigarette Industry Trade Association (ECITA), and “BAT subsidiaries” as well as the 2003 funding from Philip Morris US, Polosa did not mention that he was, at the time, principal investigator of a large PMI-funded study.
In 2015, Polosa lobbied the Australian government on the topic of tobacco harm reduction without disclosing any conflicts of interest.³⁷

In peer-reviewed publications on tobacco harm reduction, Polosa has frequently disclosed research funding from a range of pharmaceutical companies such as GlaxoSmithKline, Pfizer and Boehringer-Ingelheim, as well as financial contributions from e-liquid manufacturers. However, while his Philip Morris funding is acknowledged in the publications which originated directly from Philip Morris-funded research,³⁸³⁹ Polosa’s subsequent publications on the topic of tobacco harm reduction fail to declare this.^{40414243444546474849}

Further, in publications where Polosa does list CoEHAR as an affiliation, often no mention is made of CoEHAR’s links to FSFW, nor FSFW’s links to PMI in conflicts of interest statements.^50515253

In his role as a speaker at the 2015, 2016, and 2017 E-cigarette Summit, Polosa declared funding from pharmaceutical companies GlaxoSmithKline and Pfizer, and that he served as a consultant for Pfizer and Arbi Group Srl , the distributor of Categoria e-cigarettes. He did not declare his funding from Philip Morris.⁵⁴⁵⁵

Tobacco Tactics Links

• CoEHAR
• Philip Morris International
• Foundation for a Smoke-Free World
• Foundation for a Smoke-Free World Grantees
• Foundation for a Smoke-Free World Centres of Excellence
• E-Cigarettes: Mixing Research and Marketing
• Global Tobacco and Nicotine Forum
• Polosa has also been a speaker at the Global Forum on Nicotine