Pinney Associates

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PinneyAssociates is a health consultancy based in the United States (US), which has actively promoted tobacco harm reduction.

Pinney Associates website states that it helps its “pharmaceutical and consumer healthcare clients to reduce their regulatory risk and enhance the commercial value of its life sciences products”.1

Background

PinneyAssociates was founded in 1994 by John Pinney, who previously worked at the US Office of the Secretary of Health, Education and Welfare and co-founded the Harvard University’s Institute for the Study of Smoking Behaviour and Policy.2 Pinney served as the executive editor on four Surgeon General’s Reports on the health consequences of smoking.

Key people in the PinneyAssociates’ leadership team have worked on tobacco issues:34

  • John Pinney – Founder and CEO
  • Joe Gitchell – President
  • Jack Henningfield – Vice President Research, Health Policy and Abuse Liability
  • Saul Shiffman – Senior Scientific Advisor, Behavioral Science, Study Design and Analysis
  • Robyn Gougelet – Director, Health Policy and Regulatory Strategy

Relationship with the Tobacco Industry

Image 1: Screengrab from pinneyassociates.com, taken November 2017, disclosing that its harm reduction work is funded by a tobacco company

Speaker at Tobacco Industry Event

Since 2014, PinneyAssociates staff have been regular invited speakers at the Global Tobacco and Nicotine Forum, an annual tobacco industry event previously known as the Global Tobacco Networking Forum. See also:

PinneyAssociates did not appear on the list of invited speakers in 2018.5

Financial Interest in Tobacco Company’s Nicotine Gum

PinneyAssociates’s Jack Henningfield, a leading expert on tobacco control and addiction, has disclosed that he shares a patent for a nicotine gum that is under license to Niconovum, a wholly-owned subsidiary of Reynolds American (RAI) tobacco company, now owned by British American Tobacco (BAT).6

Harm Reduction Work Exclusively Funded by Tobacco Company

From February 2015 to September 2019, PinneyAssociates’ work on tobacco harm reduction was exclusively funded by RAI (see image 1).789

RAI has been wholly owned by BAT since July 2017. At the time of the agreement with RAI, John Pinney said:

“Our overriding objective is to minimize the death and disease caused by conventional cigarette smoking as quickly as possible and we believe we have a powerful opportunity to advance this objective with these new relationships”8

In 2018, Henningfield and Pinney senior scientific adviser Saul Shiffman co-authored a letter to the journal Addiction. The letter stated that the authors worked with the tobacco industry “because the goal of tobacco/nicotine science should be a reduction in tobacco-related morbidity and mortality, and that harm reduction products can play a major role in achieving this goal”.10 The letter’s co-authors included Brad Rodu and Jed E. Rose and was linked from the PinneyAssociates’ website, at least until its funding arrangement with RAI ended.11 A number of letters criticising this standpoint were subsequently published in the same journal.10121314

From October 2019 PinneyAssociates was exclusively funded by JUUL Labs, an e-cigarette company in which Altria holds a 35% share. See below for details.

Promoted Dialogue Between Public Health and Tobacco Industry

“Our RAI Colleagues”

In January 2018, Pinney president Joe Gitchell emailed public health experts to invite them to attend a RAI briefing, scheduled for February 2018 to coincide with the Society for Research on Nicotine and Tobacco (SRNT) conference.15 The purpose of the briefing was to discuss RAI’s application to the Food and Drug Administration (FDA) to label Camel snus as ‘reduced risk’.15

Gitchell’s email implied collaboration between the tobacco industry and the public health community, referring to RAI staff as “our RAI colleagues” who were to “provide an overview of the [FDA] application and will present the behavioral [sic] data that may be of interest to you”.15

The “by-invitation only” event was to be moderated by PinneyAssociates’ Saul Shiffman, and would be followed by “cocktails and appetizers following the briefing, and a sit-down dinner, sponsored by Reynolds American Inc”.15

Influencing Science

Member of Industry-Dominated CORESTA

PinneyAssociates is a member of CORESTA,16 a research platform set up by tobacco scientists in 1956,17 and whose research activities have been said to advance the interests of the tobacco industry.18 CORESTA is run by a Board comprised of seven major tobacco manufactures, six tobacco-related suppliers) and the University of Kentucky (USA).1920

Between 2016 and 2018, PinneyAssociates’ work (the majority in collaboration with RAI) was presented at least 17 times at CORESTA meetings and events:21

In 2019, after the direct relationship with RAI ceased, Shiffman presented a paper on statistical modelling at a CORESTA meeting:

In 2019 and 2020, PinneyAssociates was listed on two papers co-authored with all the major transnational tobacco companies, relating to the development of a “consortium approach to consumer reported outcome measures” for tobacco and nicotine products.3839

In 2020, PinneyAssociates was listed on a paper co-authored by employees of JUUL Labs:

See below for more on PinneyAssociates’ relationship with JUUL Labs, an e-cigarette company in which Altria has a 35% share.

Criticised Surgeon General’s Report on E-Cigarettes

In a letter published in the journal Nicotine & Tobacco Research in July 2018, PinneyAssociates’ Annie Kleykamp criticised the methodology and challenged the objectivity of the Surgeon General’s report’s on e-cigarettes.41 The report , published in December 2016, found that the use of e-cigarettes among American youth is unsafe and has become a major public health concern requiring regulatory action, including incorporating e-cigarettes into smoke-free policies and regulating e-cigarette marketing to youth.42 Kleykamp accused the Surgeon General’s report of confirmation bias and excluding recently published studies whose findings were not in line with the Surgeon General’s findings.41

In the letter, Kleykamp declared that PinneyAssociates “works on smoking cessation and tobacco harm minimization…for Niconovum USA, Reynolds American Innovation Inc, and RAI Services Company, all subsidiaries of Reynolds American Inc. However, we do not consult on conventional, combustible cigarettes.”41 She added that that commercial interests “had no input in to any facet of this work, from its conception, analysis, writing, nor submission.”41

Funded by JUUL Labs from October 2019

From October 17 2019, PinneyAssociates stated that it was working exclusively with JUUL Labs “to advance relative risk-based regulation of nicotine and tobacco products.”43 At this point it appeared to have ended its funding relationship with RAI/BAT.

Edited Special Issue of Journal sponsored by JUUL Labs

In 2021, Saul Shiffman co-edited a special issue of the American Journal of Health Behavior, sponsored by JUUL.4445

Shiffman, and others from PinneyAssociates, co-authored 10 out of the 11 papers with JUUL employees; including one written with associates of the Centre for Substance Use Research, a consultancy based in Scotland that conducts research for JUUL Labs and tobacco companies, and has received funding from the Foundation for a Smoke-Free World.44

There was criticism of the journal, which defended the publication of the special issue.46 In July 2021, The New York Times reported that JUUL Labs had paid a total of $US57,500 for the open access journal issue, and that three members of the editorial board resigned over this arrangement.474849

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Relevant Link

Pinney Associates website

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References

  1. ↑PinneyAssociates, Science, Strategy, Solutions, website, undated, accessed May 2021
  2. ↑PinneyAssociates, Our people: John Pinney, Founder and Chief Executive, undated, accessed November 2017
  3. ↑PinneyAssociates, Our People: Senior Leadership, 2018, accessed January 2018
  4. ↑PinneyAssociates, Our People: Senior Leadership, 2021, accessed May 2021
  5. ↑Global Tobacco and Nicotine Forum 2018, Look Who’s Talking, archived August 2018, accessed May 2021
  6. ↑J. Henningfield, Global Nicotine Reduction Strategy. Personal Insights on the View From FDA and the WHO TobReg Study Group, Presented at CORESTA Congress, Berlin, 11 October 2016, accessed November 2017
  7. ↑PinneyAssociates, Tobacco harm reduction, 2017, accessed July 2018
  8. ↑abPR Newswire, PinneyAssociates and Subsidiary Enter into Product Development and Consulting Agreements with Subsidiaries of Reynolds American Inc., 19 February 2015, accessed November 2017
  9. ↑PinneyAssociates, Tobacco harm reduction, website, archived September 2019, accessed May 2021
  10. ↑abJ.R. Hughes, K.O Fagerstrom, J. Henningfield et al, Why we work with the tobacco industry, letter to the editor, Addiction, 114, 374-377, doi:10.1111/add.14461
  11. ↑PinneyAssociates, Tobacco harm reduction, website, archived September 2019, accessed May 2021
  12. ↑B. Bonevski, Why some researchers choose not to work with the tobacco industry, Addiction, Letter to the Editor, 15 October 2018, doi:10.1111/add.14471
  13. ↑W. Hall, Finding acceptable ways to fund research on e-cigarettes, Addiction, Letter to the Editor, 15 October 2018, doi:10.1111/add.14465
  14. ↑J. Taylor Hays, R.D. Hurt, Why we will never work with the tobacco industry, Addiction, Letter to the Editor, 11 February 2019, doi:10.1111/add.14582
  15. ↑abcdJ. Gitchell, “Invitation to Camel Snus MRTPA briefing in Baltimore”. Email to undisclosed public health experts, dated 19 January 2018, 18:33
  16. ↑CORESTA, 2017 CORESTA Joint Study Groups Meeting, Kitzbühel Austria, 8-12 October, Smoke Science and Product Technology, CORESTA website, accessed July 2018
  17. ↑CORESTA, Who We Are, website, undated, accessed June 2020
  18. ↑S.A. Bialous, D. Yach, Whose standard is it anyway? How the tobacco industry determines the International Organization for Standardization (ISO) standards for tobacco and tobacco products, Tobacco Control, 2001;10:96-104
  19. ↑CORESTA, A presentation of CORESTA, updated April 2020, accessed June 2021
  20. ↑CORESTA, The CORESTA Board (2020-2022), website, undated, archived January 2021, accessed June 2021)
  21. ↑CORESTA, Abstracts. Search: Pinney, accessed  May 2021
  22. ↑S. Shiffman, G. Curtin, Consumers’ perceptions of disease-specific modified-risk claims are best evaluated in a disease-specific manner, CORESTA Congress, Kunming, 2018: Smoke Science/Product Technology Groups (also presented at TSRC 2018)
  23. ↑S. Shiffman, G. Curtin, Comparing direct and indirect assessments of perceptions of reduced risk for a modified-risk tobacco product, CORESTA Congress, Kunming, 2018: Smoke Science/Product Technology Groups (also presented at TSRC 2018)
  24. ↑M.M. Kim, S. Shiffman, M. Sembower, Comparisons of dependence on cigarettes and e-cigarettes: data from the path study, TSRC, Tob. Sci. Res. Conf., 2018, 72, abstr. 030
  25. ↑M.M. Kim, S. Shiffman, M. Sembower, Use patterns and tobacco use histories among users of diverse vapor products: cigalikes, tanks, and other vapor products, TSRC, Tob. Sci. Res. Conf., 2018, 72, abstr. 031
  26. ↑G. Curtin, S. Shiffman, J. Rohay, S. Pype, TSRC, Trends in US smokers’ perceptions of the relative risks of non-combustible tobacco products versus cigarettes, Tob. Sci. Res. Conf., 2018, 72, abstr. 036
  27. ↑S. Shiffman, G. Curtin, Comparing direct and indirect assessments of perceptions of reduced risk for a modified-risk tobacco product, TSRC, Tob. Sci. Res. Conf., 2018, 72, abstr. 038 (also presented at CORESTA 2018)
  28. ↑S. Shiffman, G.M. Curtin, Consumers’ perceptions of disease-specific modified-risk claims are best evaluated in a disease-specific manner, Tobacco Science Research Conference, 2018, 72, abstr. 039 (also presented at CORESTA 2018)
  29. ↑G. Curtin, A. Bachand, S. Sulsky, et al, Addressing U.S. FDA’s population health standard for Camel Snus with modified risk messaging, CORESTA meeting, Smoke Science/Product Technology, 2017. Kitzbühel, ST 39
  30. ↑S. Shiffman, M. Sembower, M. Kim, et al, Flavored e-cigarette use among U.S. adults: results from two national surveys, CORESTA meeting, Smoke Science/Product Technology, 2017. Kitzbühel, ST 50
  31. ↑S. Shiffman, M. Sembower, M. Kim, et al, Variations in intensity of e-cigarette use, smoking history, and demographics among past-30-day e-cigarette users, CORESTA meeting, Smoke Science/Product Technology, 2017. Kitzbühel, ST 51
  32. ↑K. Frost-Pineda, J. Pillitteri, S. Shiffment, et al, Comprehension and perceptions of reduced risk information for camel snus, TSRC, Tob. Sc. Res. Conf., 2017, 71, abst. 108
  33. ↑G.M. Curtin, K. Gerlach, S. Shiffman, Reduced risk information for camel snus: projecting likelihoods of use among current smokers, former smokers and never tobacco users, TSRC, Tob. Sci. Res. Conf., 2017, 71, abstr. 109
  34. ↑A. Bachand, S.I. Sulsky, S. Shiffman, et al, Modeling the population health effects of Camel snus with reduced risk information, TSRC, Tob. Sci. Res. Conf., 2017, 71, abstr.110
  35. ↑J.E. Henningfield, What is the rationale behind TobReg’s “Global nicotine reduction strategy”?, CORESTA Congress, Berlin, 2016, Plenary Session, APSTW 01
  36. ↑S. Shiffman, K.K. Gerlach, Design and implementation of pre- and post-marketing surveillance for tobacco products, Tobacco Science Research Conference, 2016, 70, abstract.03 Symposium
  37. ↑S. Shiffman, Introduction to statistical population modeling of tobacco products and their impact on health, CORESTA Meeting, Smoke Science/Product Technology, 2019, Hamburg
  38. ↑C. Acquadero/CORESTA, A consortium approach for consumer-reported outcome measures to assess tobacco- and nicotine-containing products, CORESTA Meeting, Smoke Science/Product Technology, 2019, Hamburg, accessed June 2021
  39. ↑C. Acquadero/CORESTA, A consortium approach for consumer-reported outcome measures for assessing tobacco and nicotine-containing products, CROM Symposium, Online, 2020, archived February 2021, accessed June 2021
  40. ↑R.A. Black, S. Shiffman, M.J. Hannon, Measurement matters: psychometric analysis of the PATH Youth Dependence Scale, CROM Symposium, Online, 2020, accessed June 2021
  41. ↑abcdB.A. Kleykamp, Objectivity and Evidence in the 2016 Surgeon General’s Report on E-Cigarettes, Nicotine & Tobacco Research, Volume 20, Issue 8, 9 July 2018, Pages 1031-1032.doi:10.1093/ntr/ntx156
  42. ↑U.S. Department of Health and Human Services, E-Cigarette Use Among Youth and Young Adults. A Report of the Surgeon General, 2016, accessed June 2021
  43. ↑PinneyAssociates, Tobacco harm reduction, website, archived August 2020, accessed May 2021
  44. ↑ab American Journal of Health Behavior, JUUL Special Issue, Volume 45, Number 3, May 2021
  45. ↑S. Shiffman, E. Augustson, Introduction to the Special Issue on JUUL Use, American Journal of Health Behavior, Volume 45, Number 3, May 2021, pp. 397-401(5), doi: 10.5993/AJHB.45.3.1
  46. ↑I. Torjesen, Academic journal is criticised for publishing special issue funded by tobacco industry, BMJ, 14 May 2021; 373:n1247 doi: 10.1136/bmj.n1247
  47. ↑S. Kaplan, Juul Is Fighting to Keep Its E-Cigarettes on the U.S. Market, The New York Times, 5 July 2020 (behind paywall)
  48. ↑D. Reuter, Juul spent more than $50,000 to have a medical journal run an entire issue of pro-vaping studies funded by the company, Business Insider, 7 July 2021, accessed July 2021
  49. ↑A. Zilber, Juul paid $51k for an entire science journal where EVERY article presented evidence that vaping ‘helps smokers quit cigarettes’, Daily Mail, 20 July 2021, accessed July 2021

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