Riccardo Polosa

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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 Next Generation Products such as e-cigarettes, 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

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.10 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 2022.11

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.12

FSFW plans to fund CoEHAR until at least March 2024, according to its website.13

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 2018.14 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”.15 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.161718

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”.1920

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 2019.21 Records show that the actual study start date was 25 May 2019 and the actual completion date was 25 May 2020.22 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.23

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’.24

Collaborated with Tobacco Industry Scientists (2017/18)

Image 1. Budget of Dr Polosa’s Research Grant Application to Philip Morris

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.25

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 next generation products in a tobacco harm reduction approach to health regulation.26 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”.27 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 2005,28 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”.29

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.30 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.313233 See also the following pages:

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.3435

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.36

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,3738 Polosa’s subsequent publications on the topic of tobacco harm reduction fail to declare this.39404142434445464748

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.49505152

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.5354

Tobacco Tactics Links

References

  1. S.H. Zyoud, S.W. Al-Jabi, W.M. Sweileh, Worldwide research productivity in the field of electronic cigarette: a bibliometric analysis, BMC Public Health , 2014, 14:667
  2. University of Catania, Riccardo Polosa, accessed March 2019
  3. University of Catania, CoEHAR, accessed 21 March 2019
  4. P. Berge, E Cigarette Interview with Professor Riccardo Polosa, The Ash Tray blog, October 2011, accessed March 2019
  5. E-cigarette conference, Professor Riccardo Polosa, November 2014, accessed July 2018
  6. V. Nicolosi, Riccardo Polosa at the United Nations General Assembly, LIAF, 28 September 2018, accessed March 2019
  7. INNCO, About Us, INNCO website, undated, accessed May 2019
  8. PharmaCielo Ltd., PharmaCielo Appoints New and Extended Medical and Scientific Advisory Board, Cision, 9 April 2019, accessed April 2019
  9. R. O’Leary, R. Polosa and G. Li Volti, Critical appraisal of the European Union Scientific Committee on Health, Environmental and Emerging Risks (SCHEER): Preliminary opinion on electronic cigarettes, pre-print, November 2020, accessed February 2021
  10. R. Polosa et al., A 12-month randomised, double-blind, controlled, multicentre trial comparing changes in Cigarette consumption after switchinG to high or low nicotine strENgth E-cigarettes In smokers with Schizophrenia spectrum disorders: Protocol for the GENESIS Trial, pre-print, October 2020, accessed February 2021
  11. ClinicalTrials.gov, GENESIS, undated, accessed February 2021
  12. Foundation for a Smoke-Free World, Form 990-PF, 2019 Tax Return, accessed February 2021
  13. Foundation for a Smoke-Free World, Awarded Grants: ECLAT SRL, undated, accessed February 2021
  14. R. Polosa, Letter submitted by Professor Riccardo Polosa (ECG0106), February 2019, accessed March 2019
  15. Polosa added that his role at Health Diplomats involved “providing consultancy services to subsidiaries of British American Tobacco that are working on researching, developing and commercialising non-combustible nicotine and tobacco products”.
  16. Polosa, R., Morjaria, J.B., Propsperini, U., Busa, B., Pennisi, A., Gussoni, G., Rust, S., Maglia, M., Caponnetto, P., Health outcomes in COPD smokers using heated tobacco products: a 3-year follow-up, Medrxiv pre-print December 2020, accessed February 2021
  17. O’Leary, R., Polosa, R. and Li Volti, G., Critical appraisal of the European Union Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) Preliminary opinion on electronic cigarettes, Medrxiv pre-print November 2020, accessed February 2021
  18. Farsalinos KE, Polosa R, Cibella F, Niaura R., Is e-cigarette use associated with coronary heart disease and myocardial infarction? Insights from 2016 and 2017 National Health Interview Surveys, Therapeutic Advances in Chronic Disease, 2019;10:1-10
  19. PMI Science, Supported Investigator Initiated Studies, undated, accessed March 2019
  20. University of Catania, Ricerca finanziata da enti privati, archived 21 March 2019
  21. U.S. National Library of Medicine, Heated Tobacco Products vs Electronic Cigarettes NCT03569748, ClinicalTrials.gov, last update posted 2 July 2018, accessed May 2019
  22. U.S. National Library of Medicine, Heated Tobacco Products vs Electronic Cigarettes, ClinicalTrials.gov website, last update posted 27 August 2020, accessed February 2021
  23. After obtaining “the necessary approvals”, Mondati succeeded Polosa as the study’s Principal Investigator on 30 July 2018.
  24. P. Caponnetto, M. Caruso, M. Maglia, R. Emma, D. Saitta, B. Busa, P. Polosa, U. Prosperini, A. Pennisi, F. Benfatto, C. Sartorio, M. Guastella and E. Mondati, Non-inferiority trial comparing cigarette consumption, adoption rates, acceptability, tolerability, and tobacco harm reduction potential in smokers switching to Heated Tobacco Products or electronic cigarettes: Study protocol for a randomized controlled trial, Contemporary Clinical Trials Communications, 2020;17:1-9
  25. Session 24: Approaches for the assessment of next generation products. Programme of the Session, Eurotox 2017 website, undated, accessed April 2019
  26. M. Peitsch, R. Polosa, C. Proctor, et al., Next-generation tobacco and nicotine products: Substantiating harm reduction and supporting tobacco regulatory science, Toxicology Research and Application, 2018, 2:1–12, accessed April 2019
  27. Philip Morris External Research Program, Application for Research Grant, Riccardo Polosa, 26 August 2002, Truth Tobacco industry Documents, Bates no: 3001592412-3001592413, accessed September 2015
  28. Unknown, Department of Scientific Affairs Research Contracts, 14 January 2004, Truth Tobacco Industry Documents, Bates no. 3006831248-3006831263, accessed April 2019
  29. Philip Morris USA, University of Catania, External Research Agreement between Tomaselli Hospital, University of Catania and Philip Morris US Inc 1 May 2003, Truth Tobacco Industry Documents, Bates no. 3001592402-3001592411, accessed April 2019
  30. R. Polosa, Philip Morris External Program Summary. Cigarette Smoke and Endothelial/ Platelet Activation: Evaluation of Prothrombotic Markers During Smoking Sessions, 15 April 2004, Truth Tobacco Industry Documents, Bates no. 3034227269-3034227270, accessed April 2019
  31. Global Tobacco & Nicotine Forum, Look Who’s Talking. GTNF 2015: Voices from ‘The Square’, 2015, accessed March 2019
  32. Global Tobacco & Nicotine Forum, Look Who’s Talking, 2017, accessed October 2017
  33. Global Tobacco & Nicotine Forum, Look Who’s Talking 2018, 2018, accessed August 2018
  34. GFN 2019, Programme, undated, accessed June 2019
  35. GFN 2020, Programme, undated, accessed May 2020
  36. R. Polosa, Subject: Inquiry into personal choice and community impacts, submission to the Senate Economics References Committee, 18 August 2015, accessed March 2019
  37. P. Caponnetto, C. Russo, A. Di Maria et al., Circulating endothelial‐coagulative activation markers after smoking cessation: a 12‐month observational study, European Journal of Clinical Investigation, 2011
  38. R.R. Cacciola, F. Guarino, R. Polosa, Relevance of Endothelial-Haemostatic Dysfunction in Cigarette Smoking, Current Medicinal Chemistry, 2007, 14(17):1887-1892
  39. P. Caponnetto, M. Maglia, G. Prosperini, et al., Carbon monoxide levels after inhalation from new generation heated tobacco products, Respiratory Research, 2018, 19(1):164
  40. R. Polosa, P. Caponnetto, R. Niaura, et al., Analysis of E-cigarette use in the 2014 Eurobarometer survey: calling out deficiencies in epidemiology methods, Intern Emerg Med, 2017, 12:733
  41. R. Polosa , P. Caponnetto, E-cigarettes and smoking cessation: a critique of a New England Journal Medicine-commissioned case study, Intern Emerg Med, 2017, 12:129–131
  42. R. Polosa, J.B. Morjaria, P. Caponnetto, et al., Blood Pressure Control in Smokers with Arterial Hypertension Who Switched to Electronic Cigarettes, Int. J. Environ. Res. Public Health, 2016, 13(11):1123
  43. R. Polosa, E-cigarettes: Public Health England’s evidence based confusion?, The Lancet, 2015, 386(10000):1237-1238
  44. D. Nutt, L.D. Phillips, D. Balfour, et al., Estimating the Harms of Nicotine-Containing Products Using MCDA Approach, European Addiction Research 2014; 20:2018-225
  45. P. Caponnetto, D. Campagna, F. Cibella, et al., EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as Tobacco Cigarettes Substitute: A Prospective 12-Month Randomized Control Design Study, PLOS One, 2013
  46. P. Caponnetto, D. Campagna, G. Papale, et al., The emerging phenomenon of electronic cigarettes, Expert Rev Respir Med, 2012, 6(1):63-74
  47. R. Polosa, N.L. Benowitz, Treatment of nicotine addiction: present therapeutic options and pipeline developments, Trends Pharmacol Sci, 2011, 32(5):281-289
  48. G. Casella, P. Caponnetto, R. Polosa, Therapeutic advances in the treatment of nicotine addiction: present and future, Ther Adv Chronic Dis, 2010, 1(3):95-106
  49. P. Caponnetto, M. Maglia and R. Polosa, Efficacy of smoking cessation with varenicline plus counselling for e-cigarette users (VAREVAPE): A protocol for a randomized controlled trial, Contemporary Clinical Trials Communications, 2019;15(100412):1-6
  50. KE. Farsalinos, R. Polosa, F. Cibella and R. Niaura, Is e-cigarette use associated with coronary heart disease and myocardial infarction? Insights from the 2016 and 2017 National Health Interview Surveys, Therapeutic Advances in Chronic Disease, 2019;10:1-10
  51. P. Caponnetto, M. Maglia, D. Lombardo, S. Demma and R. Polosa, The role of virtual reality intervention on young adult smokers’ motivation to quit smoking: a feasibility and pilot study, Journal of Addictive Diseases, 2018;37(3-4):217-226
  52. P. Caponnetto, J. DiPiazza, GC. Cappello, S. Demma, M. Maglia and R. Polosa, Multimodal Smoking Cessation in a Real-Life Setting: Combining Motivational Interviewing With Official Therapy and Reduced Risk Products, Tobacco Use Insights, 2019;12:1-11
  53. The E-Cigarette Summit 2017 Programme, November 2017, accessed April 2019
  54. The E-Cigarette Summit 2016 Programme, November 2016, accessed April 2019
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