The Pharmaceuticalization of the Tobacco Industry Yogi Hale Hendlin, Phd; Jesse Elias, MA; and Pamela M
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Annals of Internal Medicine IDEAS AND OPINIONS The Pharmaceuticalization of the Tobacco Industry Yogi Hale Hendlin, PhD; Jesse Elias, MA; and Pamela M. Ling, MD, MPH s developing and legitimizing pharmaceutical-like, The endorsement of health authorities by certifying Ireduced-harm tobacco products giving the tobacco noncombustible products as cessation devices (in the industry a new lease on life? Cigarettes constitute more United Kingdom) or modified-risk tobacco products than 90% of the industry's profits, and the number of (MRTPs) in the United States validates TTC and smokers is increasing worldwide with population e-cigarette company claims and confers public legiti- growth. Smoking prevalence is simultaneously declin- macy. New nicotine products lacking sanction by med- ing, threatening cigarettes' long-term profitability. ical authorities may benefit from a halo effect, whereby Transnational tobacco companies (TTCs) aggressively their resemblance to pharmaceuticals leads consumers promote smoking in low- and middle-income countries to perceive them as such. Without new drug approval, but have also diversified their product lines to in- alternative nicotine products cannot be advertised as clude more socially acceptable alternative nicotine cessation devices; nonetheless, consumers may regard products, marking an industry-wide shift (1, 2). This these as de facto nicotine replacement therapy ana- pursuit of new, standardized, designer, possibly logues. Vaping advocates and some public health or- government-certified nicotine products—a process we ganizations cast e-cigarettes as cessation aids regard- call pharmaceuticalization—may fundamentally change less of certification by drug authorities. As such, the how policymakers and the public perceive both the to- industry assumes the mantle of medical legitimacy by bacco industry and its products. association. AN INDUSTRY IN TRANSITION WHAT IS PHARMACEUTICALIZATION? All major TTCs have large investments in pharma- In medical ethics, pharmaceuticalization is “the ceuticalized tobacco products. Since 2008, Philip Mor- translation or transformation of human conditions, ca- ris International has spent more than $2 billion re- pabilities and capacities into opportunities for pharma- searching reduced-risk products (1, 2). In 2016, it spent ceutical intervention” (3). Applied to tobacco, pharma- another €500 million on its heat-not-burn product ceuticalization represents the tobacco industry's actual iQOS and submitted a multimillion-page MRTP applica- and perceived transition into a pharmaceutical-like in- tion to the U.S. Food and Drug Administration in the dustry through the manufacture and sale of noncom- hopes of certifying it as a reduced-harm product. The bustible tobacco and nicotine products for smoking company ultimately aims “to replace cigarettes with cessation or long-term nicotine maintenance without RRPs [reduced-risk products] as soon as possible,” fol- the testing and oversight required of traditional phar- lowing a “scientific assessment program . inspired by maceutical products. That TTCs pursue selling nicotine standards and practices long adopted by the pharma- products—such as ZONNIC nicotine gum, which is sold ceutical industry” (2). A signal of pharmaceuticalization in the United States through Reynolds American sub- as a broader trend, in 2016 the company also invested sidiary Niconovum, and the Voke nicotine inhaler and $20 million in Syqe Medical, an Israeli manufacturer of e-Voke e-cigarettes, which were licensed by British a medical marijuana vaporizer that allows physicians to American Tobacco (BAT) subsidiary Nicoventures in the prescribe “therapeutic” doses of cannabis (5). United Kingdom—heralds a convergence between to- Reynolds American similarly sought to “migrate” bacco industry nicotine products and pharmaceutical smokers “outside traditional tobacco [to] (Pharma)... nicotine replacement therapy. Pharmaceuticalized to- to cover tobacco dependence, beyond cessation” (6). bacco products share 3 key elements with pharmaceu- In 2017, BAT acquired Reynolds American for $49 bil- ticals: standardized dosing, sleek medical design, and lion, expressing specific interest in the company's next- implicit or explicit certification or approval by relevant generation products, including its best-selling U.S. health authorities (Figure). e-cigarette brand, Vuse (7). Imperial Tobacco launched Two false intertwined assumptions facilitate phar- the e-cigarette Puritane in 2014, whereas its subsidiary maceuticalization: Substantial numbers of “inveterate” Fontem Ventures purchased e-cigarette patents from smokers cannot quit, and most smokers require phar- Dragonite International for $75 million and blu, the sec- macotherapy to do so. These premises may guide pol- ond best-selling e-cigarette brand globally, in 2015. Ja- icy away from prevention or complete cessation, sup- pan Tobacco International bought U.K. e-cigarette porting prolonged use of safer nicotine products. brand E-Lites' parent company Zandera in 2014; the Although exemplary efforts to control tobacco eschew third-largest U.S. e-cigarette company, Logic Technol- alliances with tobacco companies (4), harm reduction ogy Development; and in 2015 the heat-not-burn and accepts a nicotine maintenance industry, potentially re- vaping company Ploom. casting TTCs providing nicotine products as partners The U.K. National Health Service's approval of with health institutions. BAT's e-cigarettes as prescription cessation devices is This article was published at Annals.org on 18 July 2017. Annals.org Annals of Internal Medicine 1 Downloaded From: http://annals.org/pdfaccess.ashx?url=/data/journals/aim/0/ by a Univ of California San Francisco User on 07/17/2017 IDEAS AND OPINIONS Pharmaceuticalization of the Tobacco Industry Figure. Pharmaceuticalized nicotine (and marijuana) products owned by transnational tobacco companies. Company Sample Image Subsidiary and Products Date Notes Altria PMI Group/PMI iQOS heat-not-burn cigarette 2014 (pictured top left) NuMark MarkTen XL e-cigarette 2014 Verve Verve lozenge 2012 Green Smoke Green Smoke e-cigarette 2014 Nicocig Nicolites e-cigarette 2014 Vivid e-liquid Altria Group/PMI invested in the PMI invested $20 million in the Israeli Syqe Medical marijuana inhaler 2016 pharmaceutical marijuana company (pictured bottom left)* Syqe Medical, whose products claim to “consistently deliver metered doses at pharmaceutical-level precision.” Reynolds Niconovum American ZONNIC gum, pouch, and spray 2009 ZONNIC is an FDA-approved NRT product sold by a tobacco company. R.J. Reynolds Vapor Vuse e-cigarette 2013 Vuse is the best-selling e-cigarette in (pictured) the United States. Japan Zandera (United Kingdom) Tobacco E-Lites e-cigarette 2014 E-Lites is 1 of the top-selling e- International cigarettes in the United Kingdom. Logic Technology Development Various e-cigarette brands 2015 (pictured) Ploom e-cigarette and Ploom was acquired by Japan Tobacco heat-not-burn products 2015 International in 2015. British Nicoventures American Vype e-cigarette 2013 Vype e-cigarette is sold at Lloyd’s Tobacco Pharmacy in the United Kingdom against the advice of the Royal Pharmaceutical Society. Nicovations Voke inhaler† 2014 In 2014, Nicovations became the first e-Voke e-cigarette† 2015 company to receive licenses for both its nicotine inhaler (Voke) and, a year CHIC Group (Poland) 2015 later, its e-cigarette (e-Voke). VOLISH, PI, Provog, Cottien, and LiQueen e-cigarettes British American Tobacco 2015 glo iFuse tobacco heating product glo noncombustible cigarette 2016 (pictured) Imperial Fontem Ventures Tobacco blu e-cigarette 2014 (pictured) Puritane e-cigarette 2014 Puritane e-cigarettes are available Jai e-cigarette 2015 exclusively at U.K. pharmacy chain Boots against the advice of the Royal Pharmaceutical Society. FDA = U.S. Food and Drug Administration; NRT = nicotine replacement therapy; PMI = Philip Morris International. * Image courtesy of Syqe Medical. † Not yet released. 2 Annals of Internal Medicine Annals.org Downloaded From: http://annals.org/pdfaccess.ashx?url=/data/journals/aim/0/ by a Univ of California San Francisco User on 07/17/2017 Pharmaceuticalization of the Tobacco Industry IDEAS AND OPINIONS the paradigm of tobacco industry pharmaceuticaliza- Disclaimer: The content is solely the responsibility of the au- tion (8). The U.K. Medicines and Healthcare products thors and does not necessarily represent the official views of Regulatory Agency announced in 2013 that all nicotine- the National Institutes of Health. containing products, including e-cigarettes, would be eligible for medical licenses. In 2014, BAT subsidiary Grant Support: By the National Cancer Institute at the National Nicovations was the first company to receive licenses Institutes of Health (grants R01-CA141661 and R01-87472). for its nicotine inhaler Voke and its e-cigarette e-Voke, Disclosures: Disclosures can be viewed at www.acponline which would allow physicians in the United Kingdom to .org/authors/icmje/ConflictOfInterestForms.do?msNum=M17 prescribe these products. -0759. Requests for Single Reprints: Pamela M. Ling, MD, MPH, 530 Parnassus Avenue, Suite 366, University of California, San IMPLICATIONS FOR HEALTH Francisco, San Francisco, CA 94143-1390; e-mail, pamela.ling The health consequences of pharmaceuticalization @ucsf.edu. are 3-fold. First, it contributes to the dilution and con- fusion surrounding the real process and trust implied in Current author addresses and author contributions are avail- the