African music for beginners 3: Mali

 

I’ve had a passion for contemporary African music since the early 1980s, when I bought my first LPs by South Africa’s (late) Hugh Masekela and Cameroon’s Manu Dibango, went to my first African gig (the Congolese superstar Sam Mangwana and the African Allstars, at London’s Dominion Theatre near Waterloo). In the years since I’ve collected 1000s of LPs, cassettes, CDs and MP3s.

Before traveling to any city, I look up where its African quarter is and try to get out there to see if there are any music shops and bars.  Music shops are very sadly becoming a thing of the past as people move to digital access. I spent many lunch hours listening to music at Stern’s African Record Centre in Whitfield St just behind Tottenham Court Rd in London when I was studying there between March 1984‑November 1985. They are now an on-line shop and also have a blog.

I subscribe to the monthly email from Alastair Johnston’s invaluable Musikifan record review page, buy lots of books on African music, and maintain an ever-expanding Spotify African page. While for some artists it can be very patchy, Spotify has a delightfully vast range of African music, including a lot of very obscure archival music, sometimes replete with scratchy sounds from the old LPs from where it has been digitised.

I have recently started a Youtube page with live African music concerts.

Over the next months, I’ll post country-by-country blogs with lots of recommendations for those starting out to explore the vast catalogue of African music. I’ll only be including those that I like, with links to the tracks on my Spotify page or to Youtube when they are not available on Spotify. These are just a taste that I hope might infect you in the way I was.

Senegal selections here

Zimbabwe selection here

 

Mali

 

Ali Farka Touré

Amadou et Mariam

Boubacar Traoré

Cheikh Tidane Seck with Hank Jones

Djelimady Tounkara

Fatimata Diawara

Habib Koité

Issa Bagayago

Kasse Mady

Mama Sissoko

Rail Band de Bamako

Rokia Traoré

Salif Keita

Tinariwen

Vieux Farka Touré

African music for beginners 2: Zimbabwe

 

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I’ve had a passion for contemporary African music since the early 1980s, when I bought my first LPs by South Africa’s (late) Hugh Masekela and Cameroon’s Manu Dibango, went to my first African gig (the Congolese superstar Sam Mangwana and the African Allstars, at London’s Dominion Theatre near Waterloo). In the years since I’ve collected 1000s of LPs, cassettes, CDs and MP3s.

Before traveling to any city, I look up where its African quarter is and try to get out there to see if there are any music shops and bars.  Music shops are very sadly becoming a thing of the past as people move to digital access. I spent many lunch hours listening to music at Stern’s African Record Centre in Whitfield St just behind Tottenham Court Rd in London when I was studying there between March 1984‑November 1985. They are now an on-line shop and also have a blog.

I subscribe to the monthly email from Alastair Johnston’s invaluable Musikifan record review page, buy lots of books on African music, and maintain an ever-expanding Spotify African page. While for some artists it can be very patchy, Spotify has a delightfully vast range of African music, including a lot of very obscure archival music, sometimes replete with scratchy sounds from the old LPs from where it has been digitised.

I have recently started a Youtube page with live African music concerts.

Over the next months, I’ll post country-by-country blogs with lots of recommendations for those starting out to explore the vast catalogue of African music. I’ll only be including those that I like, with links to the tracks on my Spotify page or to Youtube when they are not available on Spotify. These are just a taste that I hope might infect you in the way I was.

See Senegal selections here

Zimbabwe

Bhundu Boys

Four Brothers

James Chimombe & the Ocean City Band

Jonah Sithole

Lovemore Majaivana

Machanic Manyeruke & the Puritans (gospel)

Oliver Mtukudzi

Real Sounds

Thomas Mapfumo & Blacks Unlimited

 

African music for beginners 1: Senegal

 

350px-Orchestra_Baobab

Orchestra Baobab

I’ve had a passion for contemporary African music since the early 1980s, when I bought my first LPs by South Africa’s (late) Hugh Masekela and Cameroon’s Manu Dibango, went to my first African gig (the Congolese superstar Sam Mangwana and the African Allstars, at London’s The Venue near Waterloo station on May 17, 1984). In the years since I’ve collected 1000s of LPs, cassettes, CDs and MP3s. In 1985-6 I ran a late night African music program on Adelaide’s 5MMM radio and more recently, I’ve played African selections three times on Simon Marnie’s Sonic Journey on ABC Sydney.

Before traveling to any city, I look up the location of its  African quarter and try to get out there to see if there are any music shops and bars.  Music shops are very sadly becoming a thing of the past as people move to digital access. I spent many lunch hours listening to music at Stern’s African Record Centre in Whitfield St just behind Tottenham Court Rd in London when I was studying there between March 1984‑November 1985. They are now an on-line shop and also have a blog.

I subscribe to the monthly email from Alastair Johnston’s invaluable Musikifan record review page, buy lots of books on African music, and maintain an ever-expanding Spotify African page. While for some artists it can be very patchy,  Spotify has a delightfully vast range of African music, including a lot of very obscure archival music, sometimes replete with scratchy sounds from the old LPs from where it has been digitised.

I have recently started a Youtube page with live African music concerts.

Over the next months, I’ll post country-by-country blogs with lots of recommendations for those starting out to explore the vast and intimidating catalogue of African music. I’ll only be including examples of those that I like, with links to the tracks on my Spotify page. These are just a taste that I hope might infect you in the way I was.

Senegal

Africando (and Africando Allstars) – African salsa

Baaba Maal

Cheikh Lô

Dexter Johnson & Super Stars de Dakar (old time jazz)

Ismaël Lô

Mansour Seck

Orchestra Baobab

Thione Seck

Toure Kunda

Wasis Diop

Youssou N’Dour

Xalam

Highlights and lowlights of World No Tobacco Day, Australia 2019

Highlights

May 31 is World No Tobacco Day. Australia has much to celebrate, no better captured in two sets of killer facts.

First, Sir Richard Peto’s Oxford University research group has produced estimates of  the changes in total and tobacco-caused mortality for a large number of countries across the 65 years 1950-2015.  Australia is one country which has seen huge falls (see figure below). In 1970, the risk of a 35 year old man dying by age 69 was 42%. 16% of those deaths would have been caused by smoking.

Forty five years later, the all-cause risk of early death had dropped by two thirds to 15%, while smoking-caused deaths had fallen by four fifths to just 3%. Australia began introducing the first baby steps in the suite of comprehensive tobacco control policies and campaigns in 1973 when the first timidly tepid warnings appeared on cigarette packs.

This is harm reduction writ very large indeed.

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Second, as more and more tobacco control policies were legislated and implemented in Australia, and campaign funding became serious, allowing mass-reach of don’t start and quit motivating messages into the whole population, the proportion of people who smoked continued falling, occasionally plateauing as political feet were sometimes removed from the accelerator, but resuming their downward spiral when tobacco control became bipartisan.

Australia has long been at or near the very front of the international pack in reducing smoking. Here are the latest available data for five nations often compared with Australia. The Australian data are from the 2017-18 ABS National Health Survey (see table 9 here)

  • Australia (2017-18 ages 18+): 15.1% (includes cigarette smokers plus all exclusive users of other combustible tobacco products)
  • USA: (2017 ages 18+) 16.7% (all combustible tobacco product users)
  • Canada (2017 ages 12+): 16.2% (cigarettes & Roll Your Own tobacco only)
  • New Zealand (2016 ages 15+) 15.7%. (Māori adults 35.3%) (cigarettes & RYO only)
  • UK (2017 ages 18+): 15.1% (cigarettes and RYO only)

In summary, of these five nations, only Australia and the USA include all combustible tobacco products in their data on “smoking” prevalence, while other nations only include cigarettes (factory made and hand-rolled). Their “smoking” prevalence figures thus underestimate the true prevalence of “smoking”. Australia and the UK have the same (lowest) smoking prevalence of these nations, although the UK data do not include combustibles other than cigarettes (for example pipes, cigars, shisha and hookah). It is therefore likely that today Australia has the lowest smoking prevalence of these nations in the vanguard of reducing ,smoking.

But wait, there’s more. This week, the Cancer Council Victoria released data on changes in smoking prevalence in Victoria, our second most populous state, between 2015-2018. The main take home findings are that  in that state we now have the lowest daily smoking prevalence ever recorded: 10.7% (down from 13.5% in 2015)  with falls in the most disadvantaged group down from 16.8% to 13%.

The same study found that less than 2% of smokers & 1% of ex-smokers vape daily. We know from large longitudinal cohort studies that sustained quitting from smoking among people who vape compares unfavourably with other ways of quitting (eg: see table below). The Victorian report concluded that “There was no evidence to suggest an increase in the use of e-cigarettes to aid cessation by Victorians who were attempting to quit across the study period”.

blog table

Tobacco control is widely regarded as the poster child of chronic disease control.  These data, on radical falls in both smoking and smoking caused deaths , show why.

Lowlights

On the day before WNTD, a triumvirate of three e-cigarette advocacy groups launched “Aussie Vape Day” in a brazen attempt to gatecrash and rain on the parade of WNTD. On April Fools day, 2019 one of these groups, launched a Go Fund Me fundraiser, setting a target of $15,000 to pay for “a dedicated website, a launch event, professionally produced videos, testimonials, social media infographics and mainstream media promotion, a flyer for beginners on how to switch and a handout on the common questions people ask.”

ATHRA’s chairman Colin Mendelsohn, opened the donations with $500 and 30 days later, another $1345 was donated by just 37 others, with 679 sharing the Go Fund Me link, apparently with very little effect. Their $1845 fell  88% short of their modest target.

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By 8pm at the end of the big day, the Twitter hashtag #AussieVapeDay had a whole 9 tweets, with collectively 4 comments, 16 retweets and 25 likes, not exactly the stuff of a national Twitter trend.

The launch event, held on a cold, windy Thursday in a Sydney suburban park looked like Groundhog Day of recent poorly attended ecig seminars held in rooms in the Victorian and NSW parliament buildings.  (see photos below).

Aussie Vape Day

Aussie Vape Day launch

(2019) VapeDay Money shot

Next year will be bigger … !!

 

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Melbourne and Sydney seminars, 2019

The health communications company, Palin Communications, issued a press release on the big day. A cover letter to recipients stated:

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Australian health and medical which have expressed scepticism and regulatory caution about ecigarettes are in lockstep with a very long list of global and international expert agencies (see here). And as for “Smoking rates fall in countries that embrace vaping and they are sure not falling here in Australia”, here was my response (the link was to the Victorian report above).

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Philip Morris International

Some bright spark at PMI decided it would be just so apposite and witty to rename World No Tobacco Day as World No Smoking Day. I’ve written several long pieces on this blog here, here and here and elsewhere about awkward questions that we all need to ask about that company’s publicly stated ambition to move all its smokers over to its heat-not-burn product. Critically, while it’s been running its global “unsmoke” campaign, its cigarettes have continued to sell well, with sales of brands like Marlboro recently increasing.

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Global, regional and national agencies concerned about e-cigarettes: statements you are unlikely to hear from vaping advocates

Screenshot 2016-11-16 12.38.26

Vaping advocates like to point to lists of agencies which support the proliferation of vaping as a way of helping smokers quit and reducing harm. They hope that uninformed readers will take from such lists that there is now virtual consensus that nicotine vaping products are established to be safe and effective, and that many august bodies have now concluded that the jury has returned with a resounding global verdict.

These lists rarely include statements from agencies who remain far from  convinced that vaping products indeed live up to the hype that their commercial and often financially supported consumer interest groups wish to see dominate public and political narratives.

Some of these interest groups have very deep pockets which enable them to pay for lavish advertising, promotional, and public relations campaigns and to fund third party groups and individuals to proselytise on their behalf, with their financial connections are often either buried deep in links within links in the fine print of websites or undeclared.

This blog post provides a list of international and national agencies and collections of researchers and public health agencies which have expressed significant concerns about e-cigarettes and other heat-not-burn nicotine delivery products.

I have provided indicative examples of cautious and sceptical statements, with links to their full reports or statements. I will update it regularly with those I have missed and as more statements are published or revised.

I’d be grateful for notification of any such additions via the comment facility on this page. [updated 30 May 2019; 3 Jun 2019]

International Agencies

Forum of International Respiratory Societies (including American College of Chest Physicians, the American Thoracic Society, the Asian Pacific Society of Respirology, Asociación Latinoamericana del Tórax, the European Respiratory Society, the International Union Against Tuberculosis and Lung Disease, the Pan African Thoracic Society, the Global Initiative for Asthma, and the Global Initiative for Chronic Obstructive Lung Disease) (2014 and 2018)

The Forum of International Respiratory Societies is composed of professional organisations and experts in respiratory disease. Member societies include Asociacio´n Latinoamericana del To´rax, the American College of Chest Physicians, the American Thoracic Society, the Asian Pacific Society of Respirology, the European Respiratory Society, the International Union Against Tuberculosis and Lung Disease and the Pan African Thoracic Society.

  • The health risk of electronic cigarettes has not been adequately studied.  (2014)
  • Potential benefits to an individual smoker should be weighed against harm to the population of increased social acceptability of smoking and use of nicotine.  (2014)
  • Electronic nicotine delivery devices should be restricted or banned, at least until more information about their safety is available. (2014)
  • There can be no argument for harm reduction in children. To protect this vulnerable population from electronic cigarettes and other nicotine delivery devices, we recommend that electronic cigarettes be regulated as tobacco products and included in smoke-free policies. Sale of electronic cigarettes should be barred to youths worldwide. Flavouring should be prohibited in electronic cigarettes, and advertising accessible by youths and young adults be banned. (2018)

International Union Against Tuberculosis and Lung Disease  (2013 and 2014)

Key messages of the 2014 statement include:

  • The safety of electronic cigarettes (ECs) or electronic nicotine delivery systems (ENDS) has not been scientifically demonstrated.
  • Adverse health effects for third parties exposed (second-hand exposure) cannot be excluded because the use of ECs leads to the emission of fine and ultrafine inhalable liquid particles, nicotine and cancer-causing substances into indoor air.
  • The benefits of ECs have not been scientifically proven. To date, few studies have assessed ECs/ENDS as a harm reduction and cessation aid; those that do exist have conflicting findings.
  • The tobacco transnationals have increasingly entered the EC/ENDS marketplace with a strong presence.
  • ENDS could undermine the implementation of the WHO Framework Convention on Tobacco Control (FCTC) Article 12 (de-normalisation of tobacco use); use of ENDS could also hamper the implementation of Article 8 (protection from exposure to tobacco smoke), as ENDS users in public places may claim that their electronic cigarette does not contain tobacco and/or does not produce second-hand tobacco smoke.
  • The Union strongly supports regulating the manufacturing, marketing and sale of ECs or ENDS, preferably as medicines.

World Federation of Public Health Associations  (2018)

The World Federation of Public Health Associations has 123 member organisations. It supports recommendations provided by the WHO in their 2014 report.

World Medical Association (2012)

The World Medical Association is a federation of 111 national medical associations, including the Australian Medical Association. In their 2012 statement Electronic igarettes and other electronic nicotine delivery systems, the WMA recommended:

  • That the manufacture and sale of e-cigarettes and other electronic nicotine delivery systems be subject to national regulatory bodies prior approval based on testing and research as either a new form of tobacco product or as a drug delivery device.
  • That the marketing of e-cigarettes and other electronic nicotine delivery systems as a valid method for smoking cessation must be based on evidence and must be approved by appropriate regulatory bodies based on safety and efficacy data.
  • That e-cigarettes and other electronic nicotine delivery systems be included in smoke free laws.
  • Physicians should inform their patients of the risks of using e-cigarettes even if regulatory authorities have not taken a position on the efficacy and safety of these products.

World Health Organization and the Framework Convention on Tobacco Control  (FCTC)

In October 2014, the WHO presented its report Electronic nicotine delivery systems to the Sixth Session of the FCTC Conference of the Parties in Moscow. The report included the following clauses:

General considerations (clauses 33–38)

  1. Smokers will obtain the maximum health benefit if they completely quit both tobacco and nicotine use. In fact, Article 5.2(b) of the Convention commits Parties not only to preventing and reducing tobacco consumption and exposure to tobacco smoke but also to preventing and reducing nicotine addiction independently from its source. Therefore, while medicinal use of nicotine is a public health option under the treaty, recreational use is not.
  2. The rapid growth of ENDS use globally can neither be dismissed nor accepted without efforts to appropriately regulate these products, so as to minimize consequences that may contribute to the tobacco epidemic and to optimize the potential benefits to public health. Thus it is important to identify public health concerns and to consider these concerns when undertaking regulation and surveillance.
  3. Regulation of ENDS is a necessary precondition for establishing a scientific basis on which to judge the effects of their use, and for ensuring that adequate research is conducted, that the public has current, reliable information as to the potential risks and benefits of ENDS, and that the health of the public is protected. Public health authorities need to prioritize research and invest adequately to elucidate evidentiary uncertainties as soon as possible. However, the greater responsibility to prove claims about ENDS scientifically should remain with the industry.
  4. When designing a regulatory strategy for ENDS, governments should bear in mind the following general regulatory objectives:

(a) impede ENDS promotion to and uptake by non-smokers, pregnant women and youth;

(b) minimize potential health risks to ENDS users and non-users;

(c) prohibit unproven health claims from being made about ENDS; and

(d) protect existing tobacco-control efforts from commercial and other vested interests of the tobacco industry.

  1. Because the product, the market and the associated scientific evidence surrounding ENDS are all evolving rapidly, all legislation and regulations related to ENDS should be adaptable in response to new scientific evidence, including evaluation of different models for ENDS regulation, as evidence accumulates.

The decision following the report:

Invites Parties to consider applying regulatory measures such as those referred to in document FCTC/COP/7/11 to prohibit or restrict the manufacture, importation, distribution, presentation, sale and use of ENDS/ENNDS, as appropriate to their national laws and public health objectives.

Australian Agencies

Australian Competition & Consumer Commission (Product Safety Australia)

“No assessment of the safety and quality of electronic cigarettes has been undertaken. If liquid nicotine is imported for uses other than therapeutic, it is considered a substance that may cause harm and requires special precautions in manufacture, handling or use.”

Australian Council on Smoking and Health (March 2019)

“there is insufficient evidence to recommend e-cigarettes as a safe and efficacious method to give up smoking. It is also important to note that we are now seeing increasing evidence of harms attributable to their use. It is also important to emphasise that there is now also convincing evidence that the use of e-cigarettes by children and young people is an on-ramp for the use of traditional cigarettes. In recent months, the US Surgeon General, Secretary for Health and Commissioner of the Food and Drug Administration have sounded an alarm about the “epidemic” of vaping there by adolescents.”

Australian Dental Association (July 2017)

“The ADA’s review of the research literature finds that much more research must occur to confirm whether the use of ecigarettes/PV/ENDS assists people to quit smoking and does not cause further health impacts… many of these devices are being presented to the market as the ‘healthy’ alternative to smoking or claim to help people quit smoking. However, ENDS, of which e-cigarettes are one example, have not been rigorously assessed for efficiency and safety by the Therapeutic Goods Administration (TGA) and therefore the quality and safety is unknown. … The model taken to regulate the marketing of e-cigarettes and personal vaporisers should mirror those that pertain to the smoking of tobacco products. With the body of scientific and clinical research about the health impacts of e-cigarettes/personal vaporisers still in their early stages of infancy, the Australian Government should draw from lessons pertaining to public policy debates regarding the health impacts of tobacco products in the 20th century.The ADA urges the Australian Government to adopt in the precautionary principle and adopt the same regulations that underpin the use, manufacturing and marketing of tobacco products; applying them to e-cigarettes and personal vaporisers and ENDS.”

Australian Medical Association (2015)

“The evidence supporting the role of e-cigarettes in cessation is mixed and low level, and e-cigarettes are not currently recognised as cessation aids by the National Health and Medical Research Council, the Therapeutic Goods Administration or the World Health Organisation. In fact, using an e-cigarette may significantly delay the decision to quit smoking.  In addition, there is uncertainty about the longer term health implications of inhaling the vapours produced by the illegally imported (and unregulated) solutions.”

Cancer Council Australia, Heart Foundation and Cancer Australia (Feb 2018 joint policy)

“Based on current evidence, the potential benefit of e-cigarettes on smoking cessation is not established, and there is increasing evidence of health harms.”

CSIRO (Commonwealth Scientific and Industrial Research Organisation) (Jun 2018)

  • The evidence available suggests that regular use of e-cigarettes is likely to have adverse health consequences.
  • The evidence is consistent in suggesting that use of e-cigarettes by non-smoking youth predicts future smoking.
  • While many smokers and former smokers state a preference for e-cigarettes as a smoking cessation method, the effectiveness of this method compared with other smoking cessation methods is not known.
  • Based on the current evidence it is not possible to ascertain whether e-cigarettes have a positive or a negative effect on health in countries where they are permitted.
  • On present evidence, it is not possible to determine whether less restrictive access to e-cigarettes would reduce rates of smoking in Australia.

Lung Foundation Australia  (2014)

“There is currently not enough evidence to suggest the use of e-cigarettes as an effective smoking cessation tool over current recommended strategies including pharmacotherapy and clinical counselling. This could change as more research is published on this subject.

While the number of toxins in an e-cigarette is fewer than those in traditional cigarettes, there are no long-term studies on the safety of e-cigarettes and concern has been expressed about the small particles inhaled when “vaping” and their health impact, particularly on youth.

Members noted that the current evidence base in relation to e-cigarettes supports maintaining and, where appropriate, strengthening the current controls that apply to the marketing and use of these products in Australia. Members agreed to national guiding principles which reflect a precautionary approach to e-cigarettes and affirmed the current national regulatory framework remains appropriate.” 

National Health & Medical Research Council (2017)

E-cigarettes may expose users to fewer toxic chemicals than conventional tobacco cigarettes; however the extent to which this reduces harm to the user has not been determined; There is currently insufficient evidence to conclude whether e-cigarettes can assist smokers to quit; There is some evidence from longitudinal studies to suggest that e-cigarette use in non-smokers is associated with future uptake of tobacco cigarette smoking.

Ministerial Drug and Alcohol Forum (27 Nov 2017)

Parliament of Australia. House of Representatives. Report on the Inquiry into the Use and Marketing of Electronic Cigarettes and Personal Vaporisers in Australia

The Committee recommends that the Therapeutic Goods Administration continues to oversee the classification of nicotine and relevant exemptions, and the assessment of any electronic cigarette product as a therapeutic good.

The Committee recommends that the Australian Government establish a regulatory process for assessing and, if necessary, restricting colourings and flavourings used in electronic cigarettes.

Public Health Association of Australia (2018)

Based on current evidence, and in line with recommendations from the WHO, the World Federation of Public Health Associations, the Cancer Council, Heart Foundation, Cancer Australia and other leading evidence-based organisations, the PHAA strongly supports a precautionary approach to the use, promotion and availability of e-cigarettes in Australia

Royal Australian College of General Practitioners (July 2014)

“Concerns about e-cigarettes include a lack of evidence for short-term efficacy and short-and long-term safety, particularly in patients with current chronic disease. Rather than cessation, concurrent use with smoking may continue. There are also concerns that e-cigarettes may potentially act as a gateway to smoking.163 However it is reasonable to conclude that if used as a substitute rather than an addition, e-cigarettes are much less harmful than continuing to smoke.”

Royal Australasian College of Physicians (May 2018)

“The RACP is concerned there remains a lack of clear and robust evidence to inform policy makers, clinicians and the public about e-cigarettes. While there is some evidence that e-cigarettes mayreduce the number of tobacco cigarettes smokers consume and that they are likely to be less harmful than tobacco cigarettes (due to lower level of potentially toxic substances in e-cigarettes compared with tobacco cigarettes), the evidence on their efficacy as aids in smoking cessation and their long-term health effects is either mixed or limited. There is also evidence indicating that their use affects the likelihood of youth initiating use of tobacco cigarettes. Based on the current evidence, at this point in time the net public health effect of e-cigarettes cannot be clarified with any degree of confidence. The RACP acknowledges that e-cigarettes may have a potential role in tobacco harm reduction and smoking cessation for smokers unable or unwilling to quit. However, due to lack of long-term data and large population studies, e-cigarettes should be treated with caution. Users should be aware when using a nicotine-containing e-liquid that nicotine is highly addictive and a poison. Any e-cigarette that claims therapeutic benefit (including smoking cessation) must undergo the appropriate regulatory approval pathway in order to be allowed to make such claims, by either the Australian Therapeutic Goods Administration or in New Zealand, Medsafe.

The RACP is of the view that e-cigarettes present no benefits and only potential harms to those who do not smoke, be they never smokers or former smokers. We are concerned that the use of e-cigarettes may increase the likelihood of tobacco smoking initiation, in particular among adolescents and young people, as indicated in some evidence. In view of this, the sale, supply, promotion and useof e-cigarettes must be effectively regulated and they should not be available to minors. E-cigarettes should be included within smoke-free environment legislation, primarily due to the potential harms from re-normalising smoking and the exposure to second-hand e-cigarette aerosol.”

Therapeutic Goods Administration (2015)

“Unlike Nicotine Replacement Therapy (NRT) products, which have been rigorously assessed for efficacy and safety and, therefore, approved by the Therapeutic Goods Administration for use as aids in withdrawal from smoking, no assessment of electronic cigarettes has been undertaken and, therefore, the quality and safety of electronic cigarettes is not known.

The Australian Government is concerned about the use of electronic cigarettes in Australia. The impact of wide-scale use of these devices on tobacco use is not known, and the outcome in the community could be harmful.”

Thoracic Society of Australia and New Zealand (2017 joint statement with Lung Foundation Australia)

{There is no good public health claim for an unregulated approach to e-cigarettes and personal vaporisers. There is a strong case for a total ban on these products as they are currently available. Currently, e-cigarettes and personal vaporisers are being marketed as a harmless life choice, without any cautionary labels or health warnings. The use of these devices causes injury to the lung. There is no reason to support an approach to regulating a product which causes ill health, contains known carcinogens and other toxic compounds. The most compelling argument for these devices, and it is an argument based on anecdotal and personal experiences rather than an evidence base, is for use in smoking cessation. It is likely that these devices are less harmful than smoking cigarettes, however they are not harmless. If they are to be used as cessation aids, then this is a therapeutic device and must be regulated as such by the Therapeutic Good Administration.”

VicHealth (July 2017)

  • ECPVs should only be made available as a smoking cessation aid if they are approved by the Therapeutic Goods Administration (TGA).
  • ECPVuse should be subject to the same restrictions as tobacco smoking,and therefore should not be permitted in existing smoke-free areas.
  • ECPVs should only be marketed as a therapeutic good if approved by the TGA.

US Agencies

American Academy of Family Physicians (April 2019)

“There are concerns about the lack of any regulatory oversight by the Food and Drug Administration’s Center for Tobacco Products on the manufacture, distribution and safety of e-cigarettes. Therefore, the AAFP calls for rigorous research in the form of randomized controlled trials of e-cigarettes to assess their safety, quality, and efficacy as a potential cessation device. The AAFP also recommends that the marketing and advertising of e-cigarettes, especially to children and youth, should cease immediately until e-cigarette’s safety, toxicity, and efficacy are established.”

American Academy of Pediatrics (2018) 

“Electronic cigarettes (e-cigarettes) are the most commonly used tobacco product among youth. The 2016 US Surgeon General’s Report on e-cigarette use among youth and young adults concluded that e-cigarettes are unsafe for children and adolescents. Furthermore, strong and consistent evidence finds that children and adolescents who use e-cigarettes are significantly more likely to go on to use traditional cigarettes—a product that kills half its long-term users. E-cigarette manufacturers target children with enticing candy and fruit flavors and use marketing strategies that have been previously successful with traditional cigarettes to attract youth to these products. Numerous toxicants and carcinogens have been found in e-cigarette solutions. Nonusers are involuntarily exposed to the emissions of these devices with secondhand and thirdhand aerosol. To prevent children, adolescents, and young adults from transitioning from e-cigarettes to traditional cigarettes and minimize the potential public health harm from e-cigarette use, there is a critical need for e-cigarette regulation, legislative action, and counterpromotion to protect youth.”

American Association for Cancer Research & American Society of Clinical Oncology (joint statement Jan 2015)

“ENDS may be beneficial if they reduce smoking rates or prevent or reduce the known adverse health effects of smoking. However, ENDS may also be harmful, particularly to youth, if they increase the likelihood that nonsmokers or formers smokers will use combustible tobacco products or if they discourage smokers from quitting. The American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) recognize the potential ENDS have to alter patterns of tobacco use and affect the public’s health; however, definitive data are lacking. AACR and ASCO recommend additional research on these devices, including assessing the health impacts of ENDS, understanding patterns of ENDS use, and determining what role ENDS have in cessation. Key policy recommendations include supporting federal, state, and local regulation of ENDS; requiring manufacturers to register with the FDA and report all product ingredients, requiring childproof caps on ENDS liquids, and including warning labels on products and their advertisements; prohibiting youth-oriented marketing and sales; prohibiting child-friendly ENDS flavors; and prohibiting ENDS use in places where cigarette smoking is prohibited.”

American Cancer Society Cancer Action Network (Feb 2018) 

“The ACS strongly recommends that every effort be made to prevent the initiation of e-cigarettes by youth.  The use of products containing nicotine in any form among youth is unsafe and can harm brain development. Furthermore, evidence indicates that young e-cigarette users are at increased risk for both starting to smoke and becoming long-term users of combustible tobacco products.

The ACS encourages the FDA to regulate all tobacco products, including e-cigarettes, to the full extent of its authority, and to determine the absolute and relative harms of each product.  The FDA should assess whether e-cigarettes help to reduce tobacco-related morbidity and mortality, and the impact of marketing of e-cigarettes on consumer perceptions and behavior.  Any related regulatory regime should include post-marketing surveillance to monitor the long-term effects of these products and ensure the FDA’s actions have the intended health outcome of significantly reducing disease and death.  Furthermore, the FDA should use its authorities to reduce the toxicity, addictiveness and appeal of tobacco products currently on the market.  The ACS also applauds the FDA for recognizing its significant role as a science-based agency in helping to address the addictiveness of nicotine in cigarettes.  Reducing nicotine in all combustible tobacco products to below addictive levels holds the potential to significantly accelerate reductions in the use of combustible tobacco products, which remain by far the leading preventable cause of cancer and preventable death in the United States.” 

American College of Cardiology (Nov 2018)

“Traditional cigarettes are an often-lifelong habit with major health implications that usually begins in adolescence. According to the CDC, youth who use e-cigarettes may be more likely to smoke in the future. When the latest e-cigarettes are designed to almost mimic a flash drive and feature flavors like strawberry and chocolate, it’s not hard to see why they’re on the rise among American youth. It is the responsibility of the health community—public organizations, medical societies and even individual clinicians—to make it less likely American children become smokers. Furthermore, we have concerns about the widespread use of a product for which, frankly, the medical and scientific community has yet to clearly establish the long-term health implications ”

American College of Physicians (Dec 2018)

“ACP’s 2015 policy paper, Electronic Nicotine Delivery Systems, highlighted the dangers that ENDS products, including e-cigarettes, present to individuals, particularly minors, and called for a ban on flavored tobacco products, which often attract minors. ACP is especially concerned about the increase in ENDS use among young people, as evidence suggests that adolescents who start using ENDS also use, or intend to use, combustible tobacco products later in life.

ACP is committed to supporting regulations that will reduce the use of all forms of tobacco products, including e-cigarettes. ACP looks forward to continuing to work with regulators and health care stakeholders to implement meaningful policy that will not only improve public health, but will take concrete steps towards combating the epidemic of ENDS use among young people.”

American College of Preventive Medicine (Jan 2019)

“The evidence behind the safety and efficacy of ENDS has not caught up with the rapid increase in widespread use of these products. Limited evidence supports the short-term efficacy of exclusive use of nicotine-containing ENDS in adults desiring to quit, with several RCTs demonstrating positive results compared with observational studies that often do not show benefit. These studies compared ENDS with no treatment, non-nicotine ENDS, or, in rare cases, NRT. There is insufficient evidence comparing the efficacy of ENDS to established evidence-based treatments.

The evidence on the benefits versus harms of e-cigarettes is still emerging. There are significant population health concerns, and it is unclear if the potential benefit to the individual adult smoker interested in quitting outweighs the potential harms of attractiveness to youth, including a gateway to cigarette smoking and changing norms around vaping and smoking.

On an individual level, limited evidence suggests that ENDS may be effective at reducing cigarette use among adult smokers intending to quit. There is insufficient evidence addressing potential long-term harms of ENDS, and limited evidence is available about short-term harms of ENDS and the impact of secondhand exposure. Although ENDS appear safer than combustible cigarettes, they are not without risk. Among youth there is no known benefit and significant concern for harm. On a population level, there may be significant harms associated with ENDS, particularly among youth nonsmokers. The long-term balance of potential benefits versus harms from the individual and population perspectives are unclear.”

American Lung Association (Feb 2019)

“The American Lung Association is very concerned that we are at risk of losing another generation to tobacco-caused diseases as the result of e-cigarettes. The Lung Association remains extremely troubled about the rapid increase of youth using these products and has repeatedly called upon the Food and Drug Administration (FDA) to increase their oversight and scrutiny of these products to protect kids.”

American Heart Association (March 2019)

Policy positions:
All marketing and advertising of tobacco products, including e-cigarettes and other non-combustible products, should be restricted. This includes online, social, television, radio, and print ads, celebrity endorsements, movie placements, price promotions, event sponsorships and branding of non-tobacco merchandise.

The FDA’s Center for Drug Evaluation and Research should collaborate with the FDA’s Center for Tobacco Products on the research and legal analysis needed to facilitate e-cigarettes being regulated and sold only as FDA-approved cessation products.

American Medical Association (2018)

“Our AMA:

(1) recognizes the use of e-cigarettes and vaping as an urgent public health epidemic and will actively work with the Food and Drug Administration and other relevant stakeholders to counteract the marketing and use of addictive e-cigarette and vaping devices, including but not limited to bans and strict restrictions on marketing to minors under the age of 21;

(2) encourages the passage of laws, ordinances and regulations that would set the minimum age for purchasing tobacco products, including electronic nicotine delivery systems (ENDS) and e-cigarettes, at 21 years, and urges strict enforcement of laws prohibiting the sale of tobacco products to minors…” 

American Public Health Association (Nov 2018)

“The safety of ENDS and their efficacy in smoking cessation programs have not been demonstrated, and scientific evidence exists to the contrary. In the United States, ENDS use has increased among all demographic groups, including young people, vulnerable populations, and minorities. Studies suggest that ENDS use increases use of combustible tobacco, and chemicals are harmful to both users and those exposed to secondhand vapor. … APHA supports efforts to regulate ENDS, urges restriction of ENDS advertising and promotion, encourages prohibition of ENDS use in public places and workplaces, calls for evidence-based research regarding ENDS efficacy in smoking cessation, and recommends prohibiting the sale of ENDS to people 21 years and younger.”

American Society of Addiction Medicine (April 2018)

“The concern with the current situation is that e-cigarettes have largely not been tested or standardized, and products offered on the market are rapidly changing, making it difficult to assess true potential benefit for cessation or harm to the user in the long term. Available evidence suggests that harm from e-cigarettes is expected to be much lower than from combustible cigarettes, which are estimated to contain roughly one hundred times the amount of toxins.  However, there are other risks associated with e-cigarettes, as there are reports of these devices spontaneously exploding, causing burns and other injuries to users. They are banned from airline flights for this reason. Finally, other modifiable forms or “mods” that rely the on use of refillable liquid nicotine solutions are at risk for contamination with other substances since the production and manufacturing of these products are not tested or regulated by any government agency or held to any standard. …

An additional concern is the still-unknown risk to young people who are currently major consumers of electronic cigarettes in the US.  Although cigarette smoking continues to decrease among American teens, use of electronic cigarettes has been escalating and surpassed use of other forms of tobacco.  A study of middle and high school students found that, among those who were current users of tobacco products, an estimated 70.0% (3.26 million) had used at least one flavored tobacco product in the past 30 days.  The long-term effects of this are unknown. There are concerns that, as prevention efforts to educate children on the harms of tobacco in cigarettes had a positive impact on teen cigarette use, the tobacco industry has promoted alternative ways to attract teens to smoking by adding flavoring and engaging in direct advertising. These strategies coincide with the rise in e-cigarette use among youth, thereby increasing exposure and the potential for the development of addiction involving the use of nicotine. Lastly, there is a potential risk that e-cigarette use will be a gateway to subsequent combustible tobacco and other drug use, including marijuana; however, research findings on such long-term effects will not be available for some time.”

American Society of Clinical Oncology Joint Statement with American Association for Cancer Research (Jan 2015)

“ENDS may be beneficial if they reduce smoking rates or prevent or reduce the known adverse health effects of smoking. However, ENDS may also be harmful, particularly to youth, if they increase the likelihood that nonsmokers or formers smokers will use combustible tobacco products or if they discourage smokers from quitting. The American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) recognize the potential ENDS have to alter patterns of tobacco use and affect the public’s health; however, definitive data are lacking. AACR and ASCO recommend additional research on these devices, including assessing the health impacts of ENDS, understanding patterns of ENDS use, and determining what role ENDS have in cessation. Key policy recommendations include supporting federal, state, and local regulation of ENDS; requiring manufacturers to register with the FDA and report all product ingredients, requiring childproof caps on ENDS liquids, and including warning labels on products and their advertisements; prohibiting youth-oriented marketing and sales; prohibiting child-friendly ENDS flavors; and prohibiting ENDS use in places where cigarette smoking is prohibited.”

American College of Obstetricians and Gynecologists (May 2017)

  • Exhaled ENDS vapor is not harmless water vapor—it has been shown to contain chemicals that cause cancer, can cause harm to unborn babies, and is a source of indoor air pollution. ENDS are promoted as a way to smoke where smoking is prohibited. However, state and local officials are incorporating ENDS use into existing smoke-free air regulations to protect health.
  • Some people use ENDS as a way to quit smoking combustible cigarettes, but current evidence is insufficient to recommend ENDS for tobacco cessation in adults, and some people use both devices due to the addictive nature of nicotine.

ENDS are a health hazard

  • ENDS companies can legally promote these products by using techniques that cigarette companies have not been able to use since the 1998 Master Settlement Agreement, including television and radio ads, billboards, outdoor signage, and sponsorships.
  • ENDS and ENDS solutions are available in many flavors (bubble gum, chocolate, peppermint, etc.) that appeal to youth. Flavors, design, and marketing renormalize and glamorize smoking

National Academies of Science, Engineering and Medicine (Jan 2018)

Selected conclusions:

Conclusion 3-1. There is conclusive evidence that e-cigarette use increases airborne concentrations of particulate matter and nicotine in indoor environments compared with background levels.

Conclusion 4-1. There is conclusive evidence that exposure to nicotine from e-cigarettes is highly variable and depends on product characteristics (including device and e-liquid characteristics) and how the device is operated.

Conclusion 4-2. There is substantial evidence that nicotine intake from e-cigarette devices among experienced adult e-cigarette users can be comparable to that from combustible tobacco cigarettes.

Conclusion 5-1. There is conclusive evidence that in addition to nicotine, most e-cigarette products contain and emit numerous potentially toxic substances.

Conclusion 5-2. There is conclusive evidence that, other than nicotine, the number, quantity, and characteristics of potentially toxic substances emitted from e-cigarettes are highly variable and depend on product characteristics (including device and e-liquid characteristics) and how the device is operated.

Conclusion 7-1. There is substantial evidence that e-cigarette aerosols can induce acute endothelial cell dysfunction, although the long-term consequences and outcomes on these parameters with long-term exposure to e-cigarette aerosol are uncertain.

Conclusion 7-2. There is substantial evidence that components of e-cigarette aerosols can promote formation of reactive oxygen species/oxidative stress. Although this supports the biological plausibility of tissue injury and disease from long-term exposure to e-cigarette aerosols, generation of reactive oxygen species and oxidative stress induction is generally lower from e-cigarettes than from combustible tobacco cigarette smoke.

Conclusion 8-1. There is substantial evidence that e-cigarette use results in symptoms of dependence on e-cigarettes.

Conclusion 10-1. There is no available evidence whether or not e-cigarette use is associated with intermediate cancer endpoints in humans. This holds true for e-cigarette use compared with use of combustible tobacco cigarettes and e-cigarette use compared with no use of tobacco products.

Conclusion 10-2. There is limited evidence from in vivo animal studies using intermediate biomarkers of cancer to support the hypothesis that long-term e-cigarette use could increase the risk of cancer; there is no available evidence from adequate long-term animal bioassays of e-cigarette aerosol exposures to inform cancer risk.

Conclusion 10-4. There is substantial evidence that some chemicals present in e-cigarette aerosols (e.g., formaldehyde, acrolein) are capable of causing DNA damage and mutagenesis. This supports the biological plausibility that long-term exposure to e-cigarette aerosols could increase risk of cancer and adverse reproductive outcomes. Whether or not the levels of exposure are high enough to contribute to human carcinogenesis remains to be determined.

Conclusion 11-1. There is no available evidence whether or not e-cigarettes cause respiratory diseases in humans.

Conclusion 16-1. There is substantial evidence that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults.

Conclusion 17-1. Overall, there is limited evidence that e-cigarettes may be effective aids to promote smoking cessation.

National Alliance for Hispanic Health (April 2019)

“E-cigarettes are addicting a new generation of smokers and online retail sales are a driving force. We applaud the bipartisan introduction today of the Preventing Online Sales of E-Cigarettes to Children Act to close the online door to underage sales and protect the health of our children … E-cigarette sales are driving a youth tobacco tipping point.  It is time for us to protect youth and give parents the tools they need to ensure their children cannot easily evade age restrictions on purchase of e-cigarettes”

Prevention Institute (Aug 2016)

“Big Tobacco and its allies have been trying to obscure the emerging science on the dangers e-cigarettes pose to public health. But claims that “vaping” is a healthier alternative to cigarettes, instead of a gateway, were disproven by a recent American Journal of Public Health study that found smokers who have used e-cigarettes are less likely to cut back on cigarettes in the future than smokers who haven’t used them.”

U.S. Preventative Services Task Force (Sept 2015)

“The evidence on the benefits versus harms of e-cigarettes is still emerging. There are significant population health concerns, and it is unclear if the potential benefit to the individual adult smoker interested in quitting outweighs the potential harms of attractiveness to youth, including a gateway to cigarette smoking and changing norms around vaping and smoking
The USPSTF concludes that the current evidence is insufficient to recommend electronic nicotine delivery systems (ENDS) for tobacco cessation in adults, including pregnant women.”

US Surgeon General (2016)

“The use of products containing nicotine poses dangers to youth, pregnant women, and fetuses. The use of products containing nicotine in any form among youth, including in e-cigarettes, is unsafe.. E-cigarette aerosol is not harmless. It can contain harmful and potentially harmful constituents, including nicotine. Nicotine exposure during adolescence can cause addiction and can harm the developing adolescent brain. 

U.S. Food and Drug Administration

Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes

“Today, I’m pursuing actions aimed at addressing the disturbing trend of youth nicotine use and continuing to advance the historic declines we’ve achieved in recent years in the rates of combustible cigarette use among kids.”

“Today, I’m announcing proposals to help reverse these trends, with the unwavering support of HHS Secretary Alex Azar, who shares my deep commitment to protecting the health of our nation’s children. Today, we advance our efforts to combat youth access and appeal with a policy framework that firmly and directly addresses the core of the epidemic – flavors.

The data show that kids using e-cigarettes are going to be more likely to try combustible cigarettes later. This is a large pool of future risk.”

“These increases must stop. And the bottom line is this: I will not allow a generation of children to become addicted to nicotine through e-cigarettes. We won’t let this pool of kids, a pool of future potential smokers, of future disease and death, to continue to build. We’ll take whatever action is necessary to stop these trends from continuing.”

Understanding the Health Impact and Dangers of Smoke and ‘Vapor’

“While we’re still learning about the long-term potential benefits and health risks of e-cigarettes and related products, existing scientific research offers some clear evidence that several of the dangerous chemicals in tobacco smoke are also present in the aerosol of some e-cigarette products. And this is concerning because of the very technology that distinguishes e-cigarettes — their delivery system that feeds aerosol into the body. We know that aerosol exposure is a major health concern due to the ability of aerosol particles to penetrate deeply into the respiratory system. E-cigarette aerosols can enter the lungs and small airways in various ways, which may depend on a number of factors, including nicotine content and the type of e-cigarette. That means some of the toxic chemicals and other substances contained in e-cig aerosols have the potential to go deep into the lungs and may pose risk for diseases not usually seen in smokers.

This is why we’ve been so concerned about youth use of these products. It’s not just the addiction to nicotine, and the potential for kids who become addicted to nicotine from e-cigarettes to eventually transition to regular combustible cigarettes. It’s also the direct risks posed by the e-cigarettes themselves.

This isn’t idle speculation. We know the aerosol produced by some e-cigarettes can contain high amounts of some toxic substances.”

“Still another potential danger from certain types of e-cigarette designs can relate to the metal coil elements that heat and cool the product.”

“The mounting research on the physical impacts of aerosol produced by e-cigarettes provides a strong basis for concern. This is especially true when it comes to use of these products by children. But there remains a great deal to learn.”

“We’re especially concerned by evidence from animal studies that the vapor in e-cigarettes can cause changes to tissue in the airways that can induce cancer or be a precursor to cancer. We have initiated a comprehensive research plan to fully evaluate these risks, and we will report our results publicly.”

“The FDA has made a strong commitment and taken a number of actions to address the addictiveness posed by nicotine in cigarettes. However, there are now new concerns about the dangers from aerosols inhaled by users of e-cigarettes. We see potential opportunity from the ENDS products for currently addicted adult smokers to help them quit smoking. But we also see risk, especially when it comes to youth use of these products.”

“…we also must consider the risks of use by youth and others not already addicted to cigarettes. Whether it’s traditional cigarettes or e-cigarettes, the FDA will remain especially firm in preventing kids from using and becoming addicted to tobacco products.”

US National Institute on Drug Abuse (2015)

“Some people believe e-cigarettes may help lower nicotine cravings in those who are trying to quit smoking. However, e-cigarettes are not an FDA-approved quit aid, and there is no conclusive scientific evidence on the effectiveness of e-cigarettes for long-term smoking cessation… E-cigarettes haven’t been thoroughly evaluated in scientific studies. For now, not enough data exists on the safety of e-cigarettes, how the health effects compare to traditional cigarettes, and if they are helpful for people trying to quit smoking. “

Europe

European Public Health Association (2018)

The health risks associated with e-cigarettes remain uncertain but they cannot be considered safe. What is certain is that statements that they are some percentage safer than conventional cigarettes are so far unjustified… Overall, e-cigarettes may help some smokers quit but, for most, e-cigarettes depress quitting…. The net effect of making e-cigarettes widely available, at population level, seems likely to be an increase in sole and dual use of e-cigarettes and sole smoking unless there is very stringent regulation.”

European Respiratory Society: Task Force report  (2018)

“ECIG aerosol contains potentially toxic chemicals. As compared to conventional cigarettes, these are fewer and generally in lower concentrations. Second-hand exposures to ECIG chemicals may represent a potential risk, especially to vulnerable populations. There is not enough scientific evidence to support ECIGs as an aid to smoking cessation due to a lack of controlled trials, including those that compare ECIGs with licenced stop-smoking treatments. So far, there are conflicting data that use of ECIGs results in a renormalisation of smoking behaviour or for the gateway hypothesis. Experiments in cell cultures and animal studies show that ECIGs can have multiple negative effects. The long-term effects of ECIG use are unknown, and there is therefore no evidence that ECIGs are safer than tobacco in the long term. Based on current knowledge, negative health effects cannot be ruled out.”

plus statement in May 2019 “”There is also a lack of evidence to support the claims that e-cigarettes are more effective than established smoking cessation medications or nicotine replacement therapies, but the few independent studies that have been published indicate that e-cig and heated tobacco device use undermines quit attempts outside of a clinical setting, and show that most people use alternative nicotine delivery products alongside conventional cigarettes, rather than as a replacement.”

OTHER NATIONS

Indian Council on Medical Research (2019)

“Based on the currently available scientific data from multiple streams of research, the Council recommends complete prohibition on ENDS or e-cigarettes in India in the greater interest of protecting public health, in accordance with the precautionary principle preventing public harm from a noxious agent, considering the following facts and circumstances:

• ENDS or e-cigarettes contain nicotine solution, which is highly addictive, and also contain other ingredients as flavouring agents and vapourizers, which are also harmful for health.

• Use of ENDS or e-cigarettes has documented adverse effects on humans which include DNA damage; carcinogenesis; cellular, molecular and immunological toxicity; respiratory, cardiovascular and neurological disorders and adverse impact on foetal development and pregnancy.

• The magnitude of potential short-term and long-term health risks to the users still remains undetermined at the population level since the products are recent and come in diverse forms.

• Whereas, the degree to which, if at all, the ENDS or e-cigarettes benefit as tobacco cessation aides is not firmly established, evidence suggests that there is a risk of dual use to some extent and initiation to tobacco addiction to non-smokers. Hence, on the balance these products have a net negative impact on public health.

• Use of ENDS can open a gateway for new tobacco addiction which is a potential threat to the country’s tobacco control laws and on-going tobacco control programmes.

• The rapidly increasing trend of use of ENDS or e-cigarettes by young persons, in countries where it was introduced, underscores a potential threat to public health.”

Acknowledgements: Quit Victoria and Campaign for Tobacco Free Kids, Washington DC.

 

 

The non-disease now on life-support: wind farm complaints in Australia are way down

The third annual report of Australia’s National Wind Farm Commissioner is about to be released. Commissioner Andrew Dyer’s recent appearance before Senate estimates and various presentations to the energy sector show that the report will cover all complaints received during 2018, and also contain all data from the very first complaint received since November 2015 when the Commission office opened. It has also now taken responsibility for investigating complaints about solar farms (5mw or more) and energy storage facilities (major batteries of 1mw or more).

The Commission combines all complaints made from a single household as one complaint, so the data is effectively best understood as a count of complaining households across Australia.

During 2018, 123 complaints were received:

  • 8 (7% of total) about four operational wind farms (there are 78 operational wind farms across Australia, meaning some 95% of Australian wind farms had  no residents who ever complained in 2018)
  • 95 (77%) about 34 proposed wind farms
  • 3 (2%) about 3 proposed solar farms
  • 17 (14%) which did not specify any existing or proposed farm

In total, across the 37 months that the office has been open for complaints, it has received 286 complaints:

  • 65 (23%) about 11 operational wind farms
  • 191 (about 51 proposed wind farms
  • 3 about 3 proposed solar farms
  • 27 which did not specify any existing or proposed farm

Of the 286 complaints, 268  (94%) have been closed by the office with the remainder still being processed.

Many complainants mention more than one issue. The Commissioner’s statement to Senate Estimates noted that “Over the three calendar years of our operations, cited issues in complaints received that have dropped considerably include health, from 46 instances to 18; noise, from 55 to 38; and vibration, from 19 to zero. Cited issues that have increased over this time include visual amenity, from 24 instances to 57; lack of community engagement, from 15 to 41; construction, from seven to 14; and planning processes, from 26 to 42.” Most of these concern farm that were not even operating when the complaints were made.

The phenomenon of complaints about wind farms is by no means the first time we have seen communities expressing anxiety about new technology, with small minorities of those who are anxious, expressing that anxiety through complaints and sometimes somaticizing it in symptoms.

Perhaps the most recent and pertinent comparison here is with mobile phone towers and the phones themselves. The heyday of anxiety about these was in the mid-1990s, when cell phone use began to accelerate rapidly. Within a few years, a large and quickly a very large proportion of the population was using cell phones. The resulting service demands required that transmission towers mushroom across all countries.

Mobile phones and towers rapidly moved from being exotic technologies to being near-ubiquitous in every nation on earth. While outbreaks of health concerns were quite common in the early years of phone use, today they have long been a phenomenon of the past. It is now around 25 years since reports of protests about mobile phone towers regularly featured in Australian news media.

While there are still die-hard enclaves of passionate crusaders against mobile phones and Wi-Fi, these are tiny. Their dire warnings in the face of no evidence of any increase in the diseases they have constantly warned us all about have rendered them as marginal and eccentric as the occasional person we have all encountered who tells us they would never have a microwave oven, a computer or a television in their home because ‘those things are deadly’. Here, there is probably no rival for heroic predictions gone badly wrong than that made in 2006 by two researchers who predicted that by 2017, half of all the world’s population would have developed electrosensitivity.

The ever-diminishing number of complaints — including health complaints – documented in  the forthcoming third report of the Commissioner, shows that the sub-culture of complaint about wind farms is almost now on life support. This was entirely predictable for any student of the history non-diseases attributed to new technologies when they first appear.

Own goal from wind farm loathing senators?

The cabal of former wind farm loathing senators (Madigan, Leyonhjelm, Xenophon, Day) whose infamous 2015 report gave birth to the national wind farm commissioner via the appeasing Abbott government can be seen today to have kicked a massive own goal.  In their fevered imaginations, they would have hoped that a government sponsored complaints office would be deluged with complaints about these evil industrial artifices blighting bucolic landscapes, decimating local birds, and ruining the health of oppressed local residents.

But just the opposite occurred. The transparency of the Commissioner’s investigative processes circumvented the populist rhetoric of indifferent, corrupt and secretive wind energy companies trampling on the concerns of powerless locals. I’ve had a Google alert set for Australia’s anti- wind farm advocates, the Waubra Foundation. I’ve had nothing since in my inbox since about August 2015.

Historians of the renewable energy revolution will bookmark that there was a period of complaining about wind farms in Australia that started up in 2009 and then died away a decade later. May it rest in peace and we all learn about how predictable the rise and fall of these psychogenic “communicated diseases” are, and what we might to avoid them in the future. The final chapter in our free book and the detailed descriptions and recommendations of the National Wind Farm Commissioner’s previous reports are good places to guide how to go about this.

own goal

So, it’s apparently now “unethical” to be sceptical about e-cigarette hype.

This week, Marian Salzman, Vice President for Communications at Philip Morris International, finger-jabbed the Australian government as “morally reprehensible” for its strict regulation of e-cigarettes. The irony police were believed to be on their lunch break when the Financial Times journalist reported that gem, with WHO estimating that 7 million people die each year from using the products sold by the industry Ms Salzman works for. A chihuahua which nipped an ankle would feel just as chastened if warned to stop by a rabid pit bull terrier.

Similar ethical tut-tutting has also surfaced in scholarly circles. Three Australian researchers, Wayne Hall, Kylie Morphett and Coral Gartner (hereafter HMG), recently published a paper in a bioethics journal where they slammed Australia’s current policy on e-cigarettes and those supporting it as being “based on strong interpretations of weak evidence”, as paternalistic, and embodying “an incoherent approach to managing health risks.” At the end of the paper, they make suggestions for how they believe things should change.

Below, I critically examine their arguments and proposals.

In Australia, nicotine (except when sold in tobacco products – more on this below) is regulated as either a therapeutic substance or a poison. Anyone wanting to make therapeutic claims for nicotine (such as that it has an acceptable risk profile in the doses in which it will be used, and is useful in helping smokers quit smoking) has to get Therapeutic Goods Administration approval for any products they wish to make such claims about. The TGA has long-established procedures for assessing the evidence for such claims.

E-cigarette advocates make three foundational claims for the benefits of vaping: that it is all but totally safe; that it is a very good way for smokers who are “unable” to quit smoking to do so; and that by making it easily available, there will be negligible collateral adverse effects, particularly involving seeing nicotine naïve youth who would be highly unlikely to ever become dependent on nicotine in any form, to do just that. In all this, they unavoidably veer into the domain of making therapeutic claims and so, like manufacturers of any quit smoking product in Australia, require TGA oversight and authorisation.

“Many smokers are unable to quit”

As I wrote in my last blog, the notion that there are many people who just cannot quit derives from the core assumption of the hardening hypothesis: the idea that today’s smokers are mainly those who “can’t” quit smoking. They are people who are intransigent, helpless nicotine addicts, impervious to all that tobacco control policy and programs can throw at them. We all need to accept that these people will never quit and must instead dose themselves with nicotine, perhaps forever, runs the pitch.

Unfortunately for this argument, John Hughes, one of the world’s most respected and prolific researchers on smoking cessation, recently let all the air out of the hardening hypothesis tyres in a paper in Nicotine and Tobacco Research. He reviewed 26 studies on hardening and found:

“None of the 26 studies found that conversion from current to former smoking, number of quit attempts, or success on a given quit attempt decreased over time and several found these increased over time.” He concluded “Some have argued that a greater emphasis on harm reduction or intensive treatment approaches is needed because remaining smokers are those who are less likely to stop with current methods. The current review finds no or little evidence for this rationale.”

The idea that we have reached rock-bottom and that all remaining smokers need to switch to e-cigarettes, and not quit, is not evidence-based.

“E-cigs are too important to be regulated”

Many e-cigarette advocates appear to have the missionary zeal of those who, cult-like, believe their calling to spread their gospel of good news places them above others who must line up and play by the regulatory rules. They want to highlight claims of efficacy and safety, but believe their cause is so important that they should be above regulation.

They are on a mission to save a billion lives this century (achievable with two very minor caveats, that e-cigs indeed are almost benign, and that every smoker around the world in the next 80 years will switch completely to vaping). They claim e-cigarettes have therapeutic benefits seldom seen in the history of public health. One calmly described them as “the most significant advance since antibiotics.” The subtext of this pitch is that e-cigarettes are far too important to be constrained by red-tape regulation.

Purveyors of useless and sometimes dangerous quack cures for cancer, HIV, asthma and other serious diseases cannot get endorsement for their claims unless they submit them for assessment and provide high quality evidence in support. HMG presumably would fully support such scrutiny and feel pleased to live in a country where consumers are thus protected, yet think it is unethical that e-cigarette manufacturers should have to meet the same standards. I believe it’s unethical that they shouldn’t have to.

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“TGA regulations are too onerous and costly”

HMG further argue that there are major obstacles to getting therapeutic substances approved. They argue that these are so onerous and costly that no one but tobacco and pharmaceutical companies could hope to stump up the costs involved:

“The small independent companies that manufacture ENDS products do not have the funds or experience in pharmaceutical regulation to conduct clinical trials or apply to have their products registered as therapeutic goods. Only tobacco or pharmaceutical companies have had the financial resources to fund clinical trials and navigate the pharmaceutical regulatory process ..”

This is an entirely specious claim. A senior official from the Department of Health told the 2017 House of Representatives enquiry into e-cigarettes:

“I do want to correct a statement that was made to the previous hearing of this committee that the application process is onerous and really expensive. Depending on the nature of a product, a smoking cessation product could be available over the counter or if it goes into the lungs it generally would become a prescription medicine. If it is an over-the-counter medicine, for example, the maximum application registration fee is $27,000; the annual one is $1,430 a year — about the same as it costs for you to renew your car registration.

I must admit that it is difficult to see how that would be a major impost on some of the significant multinational companies involved in this area. Even as a prescription medicine — and those where the nicotine goes down into the lungs rather than absorbed in the mouth, and the oromucosal services are prescription medicine — it’s a one-off cost of about $240,000 and then I think it is $3,230 [the annual fee] again, hardly onerous for a company that is expecting to have a major market presence.”

HMG believe that small e-cigarette manufacturing businesses with low capitalisation should not be penalised from market entry. Again, we do not make this argument for garage or kitchen labs making pharmaceuticals. We very sensibly argue that quality control standards involve significant investment to guarantee that those standards are always met. GMP (Good Manufacturing Practice) certification is required, and any small company without such certification should of course be excluded. Yet, HMG appear to believe this should change and that it would ethically virtuous to allow this to happen. Shredding regulatory processes refined over many years and mirrored in most advanced nations, designed to best ensure consumer protection and the integrity of therapeutic goods administration would be deeply unethical in my book.

“The government hasn’t banned cigarettes, so it should not ban e-cigarettes”

HMG make this argument one of their centerpieces, triumphantly returning several times to what they appear to believe is its impervious “gotcha” status. Their argument here runs (1) it is self-evident that cigarettes are far more dangerous than e-cigarettes (2) cigarettes have always been sold and are not banned from sale (3) therefore, consistency and coherency demand that e-cigarettes should also be allowed to be sold in the same way because of the precedent established with cigarettes.

Their syllogism takes no account of the reasons why cigarettes are sold in the way they are today, and not in the way restricted substances like prescribed drugs are sold to consumers.  Sales of cheap machine-made cigarettes burgeoned from the early twentieth century when there was no case against smoking, beyond that made by temperance groups. Tobacco control commenced more than 60 years later with the first tepid health warnings appearing in the USA in 1966. Across those years, tobacco consolidated its special exceptionalist regulatory status as being entirely exempt from ingredient controls. Even today, fully comprehensive tobacco control has been enacted in only a minority of nations.

To date, no country other than the minnow, isolated nation of Bhutan has ever contemplated banning cigarettes. Yet throughout my 40 year career, it’s been common to hear leaders in this field say “if cigarettes were invented tomorrow, when we know now what we never knew when they first appeared, no nation would allow their sale.” Aside from Brazil which bans flavouring additives , recent developments in California to ban flavoured tobacco and the nascent, glacial efforts of the US FDA to regulate tobacco products through proposals like limiting nicotine content, no nation has even taken baby steps to regulate tobacco content.

HMG are experienced enough to know that no nation will ban cigarettes any day soon. They know the legacy of cigarettes’ historical circumstances saw them (unlike pharmaceuticals, foods, beverages, cosmetics, agricultural, industrial and household chemicals) totally exempted from regulation. They know this historical legacy has tied two hands behind the backs of any thought that backwards time-travel could somehow magically allow this situation to be undone.

Importantly, they know that when proposing gold standard regulations for any product carrying serious risks, that the very last model any regulatory authority would reach for is that which applies to tobacco regulation. Yet knowing all that, they are happy to set their ethical bar to this lowest imaginable level and accuse supporters of tough regulation as being “incoherent”. We allow cigarettes to be sold everywhere, so therefore we should allow a putative less dangerous cigarette substitute to be subject to the same non-standards of regulation, they argue.

This reasoning is completely arse-up.

Instead, we should commence our comparison by saying “We made every conceivable error in the way we allowed cigarettes to be allowed into commerce, in the way we allowed it to be advertised, packaged and sold as if it was confectionary. We know that we were deceived by the tobacco industry with the harm reduction promises of filters and light/mild cigarettes. We now face a new opportunity to get regulation right with new products carrying unknown risks of daily, long-term use. Let’s learn from the disastrous history of tobacco regulation and not make the same mistakes again.”

Governments have banned leaded fuel and paint, asbestos and innumerable examples of dangerous consumer goods, all for health and safety reasons. Momentum to set endgame dates for the sale of new fossil fuel powered vehicles, new coal mines and coal-fired power stations is building fast. While Big Tobacco refuses to set target dates for stopping the sale of cigarettes, it is not inconceivable that governments will do this for them as smoking prevalence continues to fall.

“e-cigarettes are all but harmless”

The diseases caused by smoking (such as cancers, respiratory and cardiovascular diseases) typically present symptomatically several decades after chronic use commences. The famous lagged 30-50 year relationship between the rise in smoking across a population and the peak incidence of deaths caused by smoking is something that every student of public health understands (see figure below). HMG acknowledge this “ENDS have not been used for long enough, however, to assess any adverse health effects of their long-term use.” And in the finally section of the their paper where they consider what they believe are more appropriate regulatory options, they repeatedly commence their proposals with  a series of “if”s – major conditional caveats that acknowledge the very core concern that as evidence accumulates about the risks of vaping, it may well turn out that they are far from benign.

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Evidence is accumulating that e-cigarettes pose what may turn out to be considerable cardiovascular, stroke and respiratory risks, that nicotine is a tumour promoter and that dual users (those who some and vape, by far the biggest proportion of vapers) increase their nicotine intake and dependence, likely affecting their ability to quit either or both products.

There are many differences between smoking and vaping, and it is plausible that the disease profiles for smoking and vaping will eventually prove to have similarities as well as important differences. One obvious difference is in puff frequency. Ad libitum smoking in real world settings sees smokers inhale a mean 8.7 times per cigarette. The mean number of cigarettes smoked by daily Australian smokers today is 13.6, translating to 118 puffs a day. by contrast, vapers take an average 200 puffs a day and up to 600. It’s anyone’s guess what this level of unparalleled exposure to a vaporised cocktail of ingredients, many never approved as safe for inhalation, may lead to in decades to come. A precautionary regulatory position has never seemed more prudentVapers av 200 puffs a day

The peerless 2018 report of the National Academies of Science, Engineering and Medicine reached 47 conclusions across all areas of evidence about e-cigarettes. 28 (60%) of these were at levels of evidence rated as only moderate, limited, insufficient or non-existent. Our knowledge of most of the important questions about the risks and benefits of e-cigarettes is very far from mature. HMG appear to acknowledge this throughout their article, but perversely believe it is ethical to allow e-cigarettes to circumvent the regulatory oversight required of every other therapeutic agent.

“The precautionary principle as used in Australia is rudimentary and unspecified and based on an incomplete risk assessment”

E-cigarette juices are unlike routine pharmaceuticals in that they are not a standard product, sold in an exact formulation and dose. With users being able to personally adjust the power of their devices and the formulation of the e-liquids they use, this presents massive problems for regulators.

Attempts at modelling ranges of risks and benefits suffer from the same major problems. A recent example, with CG as an author, assumed the notorious 95% less dangerous than smoking factoid in developing its calculations. That figure derived from a paper where the authors wroteA limitation of this study is the lack of hard evidence for the harms of most products on most of the criteria.”  Apparently it is fine to turn on a green policy light when your risk assessments are unashamedly rudimentary and unspecified, but not to flash a red or amber light when you genuinely do not know what risks are posed by unprecedented inhalation exposures that will vary enormously between users.

Sales bans ignore adult smokers’ autonomy and are paternalistic

Public health policy has several examples of openly paternalistic restrictions and requirements where only the individual at risk might be prevented from harm (seat belts, motorcycle helmets, boat life jackets), and many, many more where risks to both individuals and others are involved. This is not the place to run a detailed argument about the justifications for paternalism, other than to note that it is a subject which is highly contested eg: Wilson’s Why it’s time to stop worrying about paternalism in health policy and which characteristically sees ultra-conservative players attacking foundations of public health policy as nanny statism. The entire domain of access to drugs policy sees decisions made every year about various levels and conditions of access to drugs with a wide range of risk-benefit ratios. These range from outright bans, to open access in supermarkets. The debate on e-cigarettes is very correctly located in this policy domain and not in some extreme libertarian anti-regulatory utopia prominently inhabited in Australia by members of the extreme right.

Ecigarettes may be a gateway to smoking in nicotine naïve teenagers

HMG argue that the evidence of the growth of vaping being associated with later uptake of smoking in hitherto nicotine naïve youth is equivocal.  In this they are correct. In the UK there appears to be little evidence at the population level that the growth of vaping has been accompanied by any increase in teenage smoking.  However Canadian data (currently under review but seen by me) on the dramatic upswing in teenage vaping also show that teenage smoking is up, something that has not occurred in 30 years.

Stand by for all manner of suggestions about how to put that genie back in its bottle.

As I have argued elsewhere, the argument that because youth smoking prevalence is down when vaping is rising, that vaping cannot possibly be causing any rise in smoking

“relies on an assumption that the population-wide net impact of any putative gateway effect of e-cigarette use would be larger than the combined net impact of all other policies, programs and factors which are responsible for reducing adolescent smoking prevalence (for example, tobacco tax and retail price, measures of the denormalisation of smoking, exposure of children to adult-targeted quit campaigns, retail display bans, health warnings and plain packaging). This is a ridiculously high bar that gateway critics demand that anyone suggesting gateway effects must jump over. It is clearly possible that significant numbers of vaping teenagers who might otherwise not have smoked could take up smoking in an environment where there was a larger preventive effect occurring in response to comprehensive efforts to reduce smoking uptake. The combined impact of such factors in preventing uptake could thereby easily mask considerable smoking uptake that might have not occurred in the absence of e-cigarettes.”

There is no evidence of any gateway effect on smoking with snus use in Sweden. Neither is there any such effect reported for NRT. But discreetly parking snus next to your gums and wearing a nicotine patch out of sight is rather different to getting your nicotine via the very public, ostentatious, semiotically dense vaping performance throughout a day. There are no snus user or NRT clubs. No one writes about the NRT or snus “lifestyle” or identifies as an NRT user in the way that many vapers do with vaping.

“Supporters of current policy have double standards in the way they use evidence”

HMG write that “Similarly, smokers’ self report of their success in quitting “cold turkey” is treated as good evidence that this is the “best way” to quit smoking; evidence from randomised controlled trials showing the superiority of drug assisted quitting to cold turkey is ignored.” Here they reference a paper I co-authored which, despite their quotation marks, nowhere contains the words “best way”. The entire argument of our paper was that unassisted quitting is, and always has been, the way that most ex-smokers finally quit. No one disputes that but many are keen that it should not be megaphoned because of the way that it might subvert the agenda of pharmaceutical and vaping companies that no quit attempt should ever proceed without one of their products.

Randomised controlled trials of drug assisted quitting do not reflect real world conditions of use. Critics have long pointed out that RCTs have many features which make them a pale shadow of how drugs are used in the real world.

RCTs often exclude people with mental illness, poor English, and no fixed address. Excluding hard-to-reach and treat participants is likely to produce more flattering results.

In the real world, people are not paid or otherwise incentivised to keep taking the drugs across the full period of the trial, so compliance is almost always far lower.

In the real world, people do not get reminder calls, texts or visits from researchers highly motivated to minimise trial drop-out. There is no “Hawthorne effect”: when trial involvement and the attention paid to participants alters the outcomes.

Nicotine-addicted people generally know very quickly if they have been allocated to the placebo arm in NRT trials because their brains feel deprived of nicotine. They invariably experience unpleasant symptoms. Knowing they have been allocated to the placebo undermines the integrity of the trial because it is important participants believe the drug might be effective.

Pots calling kettles black: selective quotations and referencing.

They say we “dismiss” observational evidence that e-cigarettes are useful in cessation, citing four references that are positive for quitting effects. This is naked pots-calling-kettles-black stuff. Might not it be equally said that they dismiss evidence that concludes that the evidence for the superiority of ecigs in cessation is poor, such as NASEM’s conclusion “Conclusion 17-1. Overall, there is limited evidence that e-cigarettes may be effective aids to promote smoking cessation.” And note that neither the US Preventive Health Services Task Force, nor the UK’s National Institute for Health and Care Excellence or Australia’s National Health and Medical Research Council, have endorsed e-cigarettes as an effective way of quitting smoking.

HMG found space after their original submission to include a supportive reference to the recent paper by Hajek et al in NEJM. They said nothing about its limitations. Selectively citing evidence that supports one’s position and accusing those who cite contradictory evidence of being unethical seems quite extreme.

They selectively quoted Prof Bruce Thompson’s evidence with Prof Anne Holland, to a Parliamentary Inquiry, given on behalf of the Thoracic Society. Thompson and Holland repeatedly stated that they could see a potential place for e-cigarettes as a smoking cessation tool subject to evidence of efficacy, safety and based on a defined product. Subjected to aggressive questioning from the Committee and its Chair, who were promoting the case for widespread availability and (presumably long-term) use, Thompson stated that it might take 10, 15 or 20 years to clarify harms.  It is hard to see how this is unreasonable, given HMG acknowledge the same concern.

Their proposed regulations

HMG make two regulatory proposals with which no one would disagree  (child proof e-liquid containers and safe storage (whatever that might mean in the real world). But they also argue for options that are laughably naïve. Restricting e-cig sales to vape shops and tobacconists apparently will prevent kids buying them. This works really well  in England. They even suggest they could be restricted to adult (sex) shops, a lobby group with such well-known political clout in Australia that they would easily persuade government to turn their backs on all other vendors clamouring for the lucrative trade.

They suggest that “The same advertising bans could also be applied as for tobacco products” (ie ALL advertising is banned). But in the very sentence before, that “No advertising would be allowed to make claims about health benefits.” Whoops. Hang on .. I thought there would be no advertising of any sort?

Dual users would be educated to switch completely to vaping. This of course works really well in England where 56% of vapers also smoke.

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If monitoring the evidence indicated that vaping was indeed of significant health concern, HMG have the solution: “these policies could be made more restrictive”. Might we ask about the details of what that very vague statement  would actually mean?

They conclude by  saying that there is poor justification for an e-cig sales ban to prevent uptake of smoking “when there are other less restrictive policies that could achieve the same goal.” In fact these policies the those which have seen daily smoking in Australian 15-17 year old children drop to a remarkable 1.9%, the lowest on record.  It has taken us many years to achieve this result. It is a kind of invaluable public health “family silverware” that is at risk with the sort of developments being seen in Canada ringing massive alarm bells.

Everyday, I take a drug  that benefits my health. I need to get a renewed doctor’s prescription four times a year to keep my supplies. I get three months supply from a pharmacy. One day, it might be rescheduled to OTC status. It’s never advertised to the public. It doesn’t come in a pretty box.  I don’t walk about feeling “medicalized” or stigmatised because I have to do these things to obtain it.

If e-cig nicotine containing juices were able to satisfy TGA safety and effectiveness requirements (and after all NRT has done so, with the very, very low bar of effectiveness they had to clear) why could not they be supplied in very much the same way?

Tailpiece

There were also some inaccuracies in the paper that suggest less than careful attention to the construction of their argument.

  1. Early in the paper, as if to paint a theatrically draconian vista, they state that “Australian ENDS users have had their homes searched by the police and been prosecuted for possessing nicotine (e.g. [14])” The reference cited is a newspaper report describing the prosecution, not of a user, but of a man who bought nicotine liquid intending “to use the nicotine in setting up his online business selling e-cigarettes until becoming aware it wasn’t legal.” The case was dismissed by the court because of the defendant’s good record. I’m aware of no ecig users who have been subjected to such treatment in Australia.
  2. Their reference #44 is hopelessly mangled.

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At Philip Morris International, it’s business. As usual.

On  February 21, 2019 I published a blog where I asked Dr Moira Gilchrist, Vice President Scientific & Public Communications at Philip Morris International, 10 sceptical questions about her company’s much trumpeted “smokefree vision” after she tweeted that she would like questions submitted.

A month later, she’s handed in her homework on my questions, publishing them on Philip Morris International’s website.  I’d urge readers to first read my questions and then her answers at the above links.

Here is my response to her efforts.

Gilchrist first corrects me for suggesting that Philip Morris International may be somehow related to Philip Morris USA (which describes cigarettes as its “core” product). She writes “Philip Morris USA is owned by Altria and is neither an affiliate of PMI nor part of the same corporate organization.”

Below are the corporate logos for the two entirely unaffiliated companies. How very odd that one company has not taken legal action against the other for using an almost wholly identical trademark!

PM Logos

The drift of Moira Gilchrist’s responses is that PMI is working as hard as it can to accelerate the transition of its cigarette smokers to its IQOS smokeless product. While 86% of its business today still comes from cigarettes, the IQOS share is rising, with a forecast of 38% net revenue by 2025. But by any assessment, cigarettes are and will remain PMI’s leading revenue earner for the foreseeable future.

While PMI’s IQOS division is pulling out all stops to urge its smoking customers to switch, down the corridor in its cigarette division and in its over-arching corporate and regulatory affairs divisions, it’s business as usual. Cigarettes are being advertised and promoted anywhere in the world where they can still legally do this. And as we will see later, tobacco control policies are being opposed whenever these threaten to accelerate the inexorable fall in smoking.

The bottom line for the company is that wherever they see lips, they fantasise about one of their products being between them. As often as possible. Notably, Gilchrist failed to answer one of my questions: “What are the KPIs (key performance indicators) for the sales, marketing and public affairs staff in your cigarette division today? Are they being asked to try and sell less cigarettes or to keep on trying to sell more? Could we all see copies of some of those please?” Why do we hear so little from PMI on its twitter feed about its army of staff bringing home the bacon for its cigarette business?

Gilchrist states “We agree that regulations should continue to dissuade people from starting to smoke or use nicotine-containing products, and also encourage people to quit.” Let me spell that out in case anyone read it too quickly. PMI says it supports regulations that dissuade people from taking up smoking “or us[ing] nicotine-containing products”.

Now consider for a moment if a parallel statement was being made by a senior official of any other industry. For example, imagine the CEO of Toyota, hand-on-heart, saying Toyota supported government efforts to do all they could to dissuade people from starting to drive and encouraging drivers to give up driving. Would such a person be still in the job that afternoon? Yet apparently, this is what we are to take as a serious, trustworthy public statement from Philip Morris.

PMI wrote in their preamble to Gilchrist’s responses “We understand the continuing distrust of cigarette companies, and we know the tobacco industry faces a trust deficit. But we are not asking for trust.” I can’t imagine why.

The problem of their loyal, addicted cigarette customers abandoning smoking without substituting another form of nicotine delivery would loom as large for PMI. This is in fact (by far) the way that most ex-smokers quit, causing there to be many more ex-smokers than current smokers in nations that have taken tobacco control seriously.

It is perfectly clear that the “smoke-free vision” blather is very much not about the company encouraging smokers to quit using cigarettes and any form of nicotine delivery device. It is about encouraging them to switch to IQOS and to use it as much as possible. That’s understandable. They are in the nicotine addiction business, something Big Tobacco has always understood as the sine qua non of its survival.

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Teens should not smoke or vape

As all tobacco companies have always done, PMI unctuously hand-wrings over its concerns about youth smoking. It doesn’t want youth to use any nicotine products:  “Our marketing code is strong and enforced globally. Our post-market research shows that initiation of IQOS use by non-smokers is very low. We remain continually vigilant and welcome constructive feedback.”

In Canada, data will soon be published showing that for the first time in 30 years, youth smoking has risen, in concert with an 80% upswing in vaping. PMI will doubtless megaphone its vigilant efforts to put this genie back in its bottle. But the history of the tobacco industry’s intense interest in young smokers speaks for itself.

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While it would never say this publicly, the company would surely be ecstatic if children and teens who were nicotine naïve were to also experiment with IQOS and e-cigarettes, become nicotine dependent and live their lives spending money to satisfy their addiction. No business in its right mind would ever seriously propose that it would do all it could to dissuade non- and ex- users of its products or services to ever become customers. Yet for decades this has been the bizarre posturing we have seen continuously about smoking from the tobacco industry. PMI has recently given youth-focussed Vice Media £5m to promote its smokeless product. Perhaps the company has developed a magic way of preventing its pro-vaping messages from ever being seen by non-smoking youth, while being very effective with those which smoke.

Gilchrist also says “We do not encourage dual use”. Encourage, no. But jump for joy? Almost certainly. We know from recent research that smokers who also vape  “leads to a reduction in the number of combustible cigarettes, but total nicotine use and dependence increases …the increase in total nicotine use and dependence could affect the ability to quit either or both products.”  I’m sure this entirely unplanned collateral benefit would have never occurred to every company in the tobacco industry that has now climbed quickly aboard the good ship Harm Reduction.

Flogging the dead hardening hypothesis horse

Dr Gilchrist anchors IQOS as being for people who would otherwise continue smoking” and  people who cannot quit smoking”. This language borrows from the core assumption of the hardening hypothesis: the idea that today’s smokers are hard-core — mainly those who “can’t” quit smoking. They are people who are intransigent, helpless nicotine addicts, impervious to all that tobacco control policy and programs can throw at them. We all need to accept that these people will never quit and must instead dose themselves with nicotine, perhaps forever, runs the pitch.

Unfortunately for this argument, John Hughes, one of the world’s most respected and prolific researchers on smoking cessation, recently let all the air out of the hardening hypothesis tyres in a paper in Nicotine and Tobacco Research. He reviewed 26 studies on hardening and found:

“None of the 26 studies found that conversion from current to former smoking, number of quit attempts, or success on a given quit attempt decreased over time and several found these increased over time.” He concluded “Some have argued that a greater emphasis on harm reduction or intensive treatment approaches is needed because remaining smokers are those who are less likely to stop with current methods. The current review finds no or little evidence for this rationale.”

Moira Gilchrist pleads for understanding that the transformation of all their smokers to IQOS users will take time. Probably lots of time. She writes that “PMI does not control the speed at which this happens on our own: governments, regulators, scientists and tobacco control activists all play a role. We encourage everyone to engage in a debate on how to bring solutions to men and women who don’t quit smoking in as short a time frame as possible.” This is code for PMI wanting  governments, regulators, scientists and tobacco control activists to inhabit the same self-serving narrow definition of “smoke-free” that PMI is promoting, and become quasi promoters of IQOS.

We are presumably supposed to cosy down at the table with them on IQOS and then watch politely while the next day the same company does all it can to defeat, dilute and delay effective tobacco control like tobacco tax, plain packaging, graphic health warnings, retail display bans and advertising bans.

What it’s up to in low income nations

Gilchrist confirmed that PM had supported the Philippine Tobacco Institute’s challenges to two Balanga City (Philippines) local tobacco control ordinances, saying that they “would deny adult smokers the opportunity to switch to smoke-free products”.

Balanga is a tiny city – by Philippine standards – of just 80,000 people. Its local government was trying to introduce a smokefree ordinance in the vicinity of a local campus. The tobacco industry has known for decades that smoking restrictions reduce smoking (and so its profits – see below) dramatically. So PMI used the courts to stomp on proposed initiative that would have also not allowed vaping in the smokefree area. This was by any assessment using a sledgehammer to crack a walnut, and obviously intended to serve as a warning to other minnow jurisdictions in impoverished nations trying to introduce what is commonplace in wealthier nations where smoking and vaping is often outlawed in public spaces.

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Another recent example comes from Indonesia. PMI, through Gaprindo,  the ‘white cigarette manufacturers association’ as recently as November 2018, fought advertising bans and opposed tax increases. The head of Gaprindo said that said that the cigarette industry has in the past  few years had experienced declining selling volume decline of 1-2%. He saidIncreasing excise tax on cigarettes twice a year will just harm the [tobacco] industry growth.”

Gilchrist says “In the past” PMI has opposed policies it considers “to be extreme and not backed by evidence of effectiveness.” Across my 40 year experience this has included almost every single platform of comprehensive tobacco control policy, with the exception of manifestly ineffective mush like signs in shops saying “we don’t sell to children”, guidelines for parents on how to have a chat with their kids about the dangers of smoking, and nicotine replacement therapy (which we know now has rock-bottom utility in helping smokers quit for good under real-world use). From this, we can take it that “extreme” means anything with any prospect of reducing smoking.

So, my verdict? No matter how many times a snake changes its skin … it is still a snake.

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As “safe as drinking coffee”? Research spoiling the e-cigarette rehabilitation of nicotine party.

”E-cigarettes are about as safe as you can get. We know about the health risks of nicotine from studies in Sweden into the use of snus, a smokeless tobacco. Nicotine is not what kills you when you smoke tobacco. E-cigarettes are probably about as safe as drinking coffee. All they contain is water vapour, nicotine and propylene glycol [which is used to help vaporise the liquid nicotine].” Professor Robert West  2013

  “Nicotine itself is not a particularly hazardous drug,” says Professor John Britton, who leads the tobacco advisory group for the Royal College of Physicians. ”It’s something on a par with the effects you get from caffeine.” Professor John Britton Chair Tobacco Advisory Group Royal College of Physicians (2013)

“Nicotine itself is probably safer than caffeine ….The case for regulating e-cigarettes as a pharmaceutical product is on a par with regulating coffee.” Professor Peter Hajek (2013)

In 2006, before the popularization of e-cigarettes,  I spent a seven month sabbatical at the World Health Organization’s International Agency for Research in Cancer at  Lyon in France. A senior colleague there had previously worked for a major pharmaceutical company at the forefront of nicotine replacement therapy (NRT). She and I had many discussions about the safety of NRT and its efficacy in helping people quit (which in real world usage, outside of professionally supported contexts – which very few smokers are interested in attending – is pretty poor).

It is well known that many smokers find NRT unsatisfactory in that it does not supply them with sufficient nicotine to overcome their cravings. I asked her why it was that the companies did not produce higher nicotine delivery products with more “grunt” which would stand a better chance of substituting for cigarettes. A cynical part of me wondered if the never-publicly-discussed business model for NRT within the pharmaceutical industry was that the dosage which  might actually succeed in helping many smokers quit would not be as profitable as the dosage levels that saw high failure rates, but which saw many smokers having repeated NRT attempts with current and newer formulations.

During one of these discussions, she told me that pharmaceutical companies were acutely aware that nicotine was not a benign drug, and that they were highly sensitive to the risks involved in trying to get  higher delivery NRT approved for use, and had collectively decided not to go down that path. The Food and Drug Administration would have almost certainly rejected such applications, she said. She handed me a pile of papers to read about what was already known about the non-benign nature of nicotine.

Below are a selection of such papers published since my time at IARC. Unfortunately, some are pay-walled, so only the abstracts are available to non-subscribers. Many though, have full text lnks.

After you read these, ask yourself: does this sound like a benign drug that should not be regulated (as was NRT) and made as freely available as coffee? Or should it be strictly regulated so that we don’t repeat the massive mistake that was made with treating cigarettes as a somehow above regulation of their ingredients and highly engineered chemistry.

Vaping advocates are frantically opposed to serious government regulation of e-cigarettes. The information below suggests such an attitude is utterly reckless.

Scott JG, Matuschka L, Niemelä S et al. Evidence of a causal relationship between smoking tobacco and schizophrenia spectrum disorders. Front. Psychiatry, 20 November 2018 |

Abstract: There has been emerging evidence of an association between tobacco smoking and schizophrenia spectrum disorders (SSD). Two meta-analyses have reported that people who smoke tobacco have an ~2-fold increased risk of incident schizophrenia or psychosis, even after adjusting for confounding factors. This study aimed to critically appraise the research which has examined the association between tobacco smoking and SSD against the Bradford Hill criteria for causality, to determine the strength of the evidence for a causal relationship. Eight longitudinal studies (seven cohort studies and one case control study) were identified which examined tobacco smoking as an exposure and psychosis as an outcome. All seven cohort studies were assessed as being of high quality using the Newcastle-Ottawa Scale. Six of the eight studies found a statistically significant positive association between tobacco smoking and onset of SSD. These studies reported a consistent association with a moderate to large effect size and a dose response relationship. The studies adjusted for multiple potential confounders including age, sex, socioeconomic status, shared genetic risk, prodromal symptoms, and comorbid cannabis and other substance use. The studies did not adjust for exposure to childhood trauma or prenatal tobacco. There was substantial though inconclusive evidence supporting a causal relationship between tobacco smoking and increased risk of SSD. If a causal relationship does exist, nicotine is most likely responsible for this association. This raises serious public health concerns about the increasing use of e-cigarettes and other products, particularly by adolescents whose nicotine use may increase their risk of SSD. Research is urgently needed to examine the association between e-cigarette use and incident psychosis, particularly in adolescents and young adults.

Gurillo P, Jauhar S, Murray RM, MacCabe JH. Does tobacco use cause psychosis? Systematic review and meta-analysis. Lancet Psychiatry 2015;2: 718–25.

Abstract: Background: Although the association between psychotic illness and cigarette smoking is well known, the reasons are unclear why people with psychosis are more likely to smoke than are the general population. We aimed to test several hypotheses. First, that daily tobacco use is associated with an increased risk of psychotic illness in both case-control and prospective studies. Second, that smoking is associated with an earlier age at onset of psychotic illness. Finally, that an earlier age at initiation of smoking is associated with an increased risk of psychosis. We also aimed to derive an estimate of the prevalence of smoking in patients presenting with their first episode of psychosis.

Methods:We searched Embase, Medline, and PsycINFO and selected observational studies in which rates of smoking were reported in people with psychotic disorders, compared with controls. We calculated the weighted mean difference for age at onset of psychosis and age at initiation of smoking. For categorical outcomes, we calculated odds ratios from cross-sectional studies and risk ratios from prospective studies.

Findings: Of 3717 citations retrieved, 61 studies comprising 72 samples met inclusion criteria. The overall sample included 14 555 tobacco users and 273 162 non-users. The prevalence of smoking in patients presenting with their first episode of psychosis was 0∙57 (95% CI 0∙52–0∙62; p<0∙0001). In case-control studies, the overall odds ratio for the first episode of psychosis in smokers versus non-smokers was 3.22 (95% CI 1.63–6.33), with some evidence of publication bias (Egger’s test p=0.018, Begg’s test p=0.007). For prospective studies, we calculated an overall relative risk of new psychotic disorders in daily smokers versus non-smokers of 2.18 (95% CI 1.23–3.85). Daily smokers developed psychotic illness at an earlier age than did non-smokers (weighted mean difference –1.04 years, 95% CI –1∙82 to –0.26). Those with psychosis started smoking at a non-significantly earlier age than did healthy controls (–0.44 years, 95% CI –1∙21 to 0∙34).

Interpretation Daily tobacco use is associated with increased risk of psychosis and an earlier age at onset of psychotic illness. The possibility of a causal link between tobacco use and psychosis merits further examination. [Note: the discussion section of this paper includes a detailed consideration of the possible role of nicotine in the development of psychosis].

Niemelä S, Sourander A, Surcel H-M et al Prenatal nicotine exposure and risk of schizophrenia among offspring in a national birth cohort. Am J Psychiatry. 2016 Aug 1;173(8):799-806.

Objective: Cigarette smoking during pregnancy is a major public health problem leading to adverse health outcomes and neurodevelopmental abnormalities among offspring. Its prevalence in the United States and Europe is 12%–25%. This study examined the relationship between prenatal nicotine exposure (cotinine level) in archived maternal sera and schizophrenia in offspring from a national birth cohort.

Method: The authors conducted a population-based nested case-control study of all live births in Finland from 1983 to 1998. Cases of schizophrenia in offspring (N=977) were identified from a national registry and matched 1:1 to controls on date of birth, sex, and residence. Maternal serum cotinine levels were prospectively measured, using quantitative immunoassay, from early- to mid-gestation serum specimens archived in a national biobank.

Results: A higher maternal cotinine level, measured as a continuous variable, was associated with an increased odds of schizophrenia (odds ratio=3.41, 95% confidence interval, 1.86–6.24). Categorically defined heavy maternal nicotine exposure was related to a 38% increased odds of schizophrenia. These findings were not accounted for by maternal age, maternal or parental psychiatric disorders, socioeconomic status, and other covariates. There was no clear evidence that weight for gestational age mediated the associations.

Conclusions: To the authors’ knowledge, this is the first study of the relationship between a maternal smoking biomarker and schizophrenia. It provides the most definitive evidence to date that smoking during pregnancy is associated with schizophrenia. If replicated, these findings suggest that preventing smoking during pregnancy may decrease the incidence of schizophrenia.

Guo, Z-Z1,Cao Q-A, Li Z-Z et al. SP600125 Attenuates Nicotine-Related aortic aneurysm formation by inhibiting matrix metalloproteinase production and CC chemokine-mediated macrophage migration. Mediators of Inflammation 2016 (full text)

Abstract Nicotine, a major chemical component of cigarettes, plays a pivotal role in the development of abdominal aortic aneurysm (AAA). c-Jun N-terminal kinase (JNK) has been demonstrated to participate in elastase-induced AAA. This study aimed to elucidate whether the JNK inhibitor SP600125 can attenuate nicotine plus angiotensin II- (AngII-) induced AAA formation and to assess the underlying molecular mechanisms. SP600125 significantly attenuated nicotine plus AngII-induced AAA formation. The expression of matrix metalloproteinase- (MMP-) 2, MMP-9, monocyte chemoattractant protein- (MCP-) 1, and regulated-onactivation, normal T-cells expressed and secreted (RANTES) was significantly upregulated in aortic aneurysm lesions but inhibited by SP600125. In vitro, nicotine induced the expression of MCP-1 and RANTESin bothRAW264.7 (mouse macrophage) and MOVAS (mouse vascular smooth muscle) cells in a dose-dependent manner; expression was upregulated by 0.5 ng/mL nicotine but strongly downregulated by 500 ng/mL nicotine. SP600125 attenuated the upregulation of MCP-1 and RANTES expression and subsequent macrophage migration. In conclusion, SP600125 attenuates nicotine plus AngII-induced AAA formation likely by inhibiting MMP- 2, MMP-9, MCP-1, and RANTES. The expression of chemokines in MOVAS cells induced by nicotine has an effect on RAW264.7 migration, which is likely to contribute to the development of nicotine-related AAA.

Dang N, Meng X, Song H. Nicotinic acetylcholine receptors and cancer (Review). Biomedical Reports 2016;4:515-518 (full text)

Abstract: Nicotine, the primary addictive constituent of cigarettes, is believed to contribute to cancer promotion and progression through the activation of nicotinic acetylcholine receptors (nAChRs), which are membrane ligand‑gated cation channels. nAChRs activation can be triggered by the neurotransmitter Ach, or certain other biological compounds, such as nicotine. In recent years, genome‑wide association studies have indicated that allelic variation in the α5‑α3‑β4 nAChR cluster on chromosome 15q24‑15q25.1 is associated with lung cancer risk. The role of nAChRs in other types of cancer has also been reported. The present review highlights the role of nAChRs in types of human cancer.

England LJ, Bunnell RE, Pechacek TF, Tong VT, McAfee TA. Nicotine and the developing human: a neglected element in the electronic cigarette debate American Journal of Preventive Medicine 2015 Aug;49(2):286-93. [full text]

Abstract: The elimination of cigarettes and other combusted tobacco products in the U.S. would prevent tens of millions of tobacco-related deaths. It has been suggested that the introduction of less harmful nicotine delivery devices, such as electronic cigarettes or other electronic nicotine delivery systems, will accelerate progress toward ending combustible cigarette use. However, careful consideration of the potential adverse health effects from nicotine itself is often absent from public health debates. Human and animal data support that nicotine exposure during periods of developmental vulnerability (fetal through adolescent stages) has multiple adverse health consequences, including impaired fetal brain and lung development, and altered development of cerebral cortex and hippocampus in adolescents. Measures to protect the health of pregnant women and children are needed and could include (1) strong prohibitions on marketing that increase youth uptake; (2) youth access laws similar to those in effect for other tobacco products; (3) appropriate health warnings for vulnerable populations; (4) packaging to prevent accidental poisonings; (5) protection of non-users from exposure to secondhand electronic cigarette aerosol; (6) pricing that helps minimize youth initiation and use; (7) regulations to reduce product addiction potential and appeal for youth; and (8) the age of legal sale.

 

Mishra M, Chaturvedi P, Datta S et al. Harmful effects of nicotine. Indian J Med Paediatr Oncol. 2015 Jan-Mar;36(1):24-31. (full text)

With the advent of nicotine replacement therapy, the consumption of the nicotine is on the rise. Nicotine is considered to be a safer alternative of tobacco. The IARC monograph has not included nicotine as a carcinogen. However there are various studies which show otherwise. We undertook this review to specifically evaluate the effects of nicotine on the various organ systems. A computer aided search of the Medline and PubMed database was done using a combination of the keywords. All the animal and human studies investigating only the role of nicotine were included. Nicotine poses several health hazards. There is an increased risk of cardiovascular, respiratory, gastrointestinal disorders. There is decreased immune response and it also poses ill impacts on the reproductive health. It affects the cell proliferation, oxidative stress, apoptosis, DNA mutation by various mechanisms which leads to cancer. It also affects the tumor proliferation and metastasis and causes resistance to chemo and radio therapeutic agents. The use of nicotine needs regulation. The sale of nicotine should be under supervision of trained medical personnel.

Grando SA.  Connections of nicotine to cancer.  Nature Reviews Cancer (2014) 14:419-429 [Full text]

Abstract: This Opinion article discusses emerging evidence of direct contributions of nicotine to cancer onset and growth. The list of cancers reportedly connected to nicotine is expanding and presently includes small-cell and non-small-cell lung carcinomas, as well as head and neck, gastric, pancreatic, gallbladder, liver, colon, breast, cervical, urinary bladder and kidney cancers. The mutagenic and tumour-promoting activities of nicotine may result from its ability to damage the genome, disrupt cellular metabolic processes, and facilitate growth and spreading of transformed cells. The nicotinic acetylcholine receptors (nAChRs), which are activated by nicotine, can activate several signalling pathways that can have tumorigenic effects, and these receptors might be able to be targeted for cancer therapy or prevention. There is also growing evidence that the unique genetic makeup of an individual, such as polymorphisms in genes encoding nAChR subunits, might influence the susceptibility of that individual to the pathobiological effects of nicotine. The emerging knowledge about the carcinogenic mechanisms of nicotine action should be considered during the evaluation of regulations on nicotine product manufacturing, distribution and marketing.

Schaal C, Chellappan SP. Nicotine-mediated cell proliferation and tumor progression in smoking-related cancers. Mol Cancer Res. 2014 Jan;12(1):14-23. (full text)

Abstract: Tobacco smoke contains multiple classes of established carcinogens including benzo(a)pyrenes, polycyclic aromatic hydrocarbons, and tobacco specific nitrosamines. Most of these compounds exert their genotoxic effects by forming DNA adducts and generation of reactive oxygen species, causing mutations in vital genes like K-Ras and p53. In addition, tobacco specific nitrosamines can activate nicotinic acetylcholine receptors (nAChRs) and to a certain extent β-Adrenergic receptors (β-ARs), promoting cell proliferation. Further, it has been demonstrated that nicotine, the major addictive component of tobacco smoke, can induce cell cycle progression, angiogenesis, and metastasis of lung and pancreatic cancers. These effects occur mainly through the α7-nAChRs, with possible contribution from the β-ARs and/or epidermal growth factor receptors (EGFRs). This review article will discuss the molecular mechanisms by which nicotine and its oncogenic derivatives such as NNK (4-methylnitrosamino)-1-(3-pyridyl)-1-butanone) and NNN (N-nitrosonornicotine) induce cell cycle progression and promote tumor growth. A variety of signaling cascades are induced by nicotine through nAChRs, including the MAPK/ERK pathway, PI3K/AKT pathway and JAK/STAT signaling. In addition, studies have shown that nAChR activation induces Src kinase in a β-arrestin-1 dependent manner, leading to the inactivation of Rb protein and resulting in the expression of E2F1-regulated proliferative genes. Such nAChR-mediated signaling events enhance the proliferation of cells and render them resistant to apoptosis induced by various agents. These observations highlight the role of nAChRs in promoting the growth and metastasis of tumors and raise the possibility of targeting them for cancer therapy

Nordenvall C, Nilsson PJ, Ye W,  Andersson TM, Nyrén O. Tobacco use and cancer survival: A cohort study of 40,230 Swedish male construction workers with incident cancer. Int J Cancer 2013; 132 (1):155-61. (full text)

Abstract: On theoretical grounds, nicotine has been implicated as a modifier of cancer progression. We investigated possible associations of smoking or use of Scandinavian moist snuff (snus) with survival after cancer among Swedish male construction workers. Snus use is associated with substantial exposure to nicotine but not to the combustion products in smoke. Among 336,381 workers with detailed information on tobacco use in 1971–1992, we observed 40,230 incident cancers. Complete follow-up through 2007 was accomplished through linkage to population and health registers. Hazard ratios (HRs) and 95% confidence intervals (CIs) for death from any cause, cancer-specific death and death from other causes were derived from Cox proportional hazards regression models adjusted for age at diagnosis, body mass index at study entry and period of diagnosis. Never users of any tobacco served as reference. Increased risks of cancer-specific death were observed both among exclusive smokers (HRall cancer 1.15, 95% CI: 1.10–1.21) and never-smoking snus users (1.15, 95% CI: 1.05–1.26). As regards deaths due to other causes, exclusive smokers had higher relative risks than exclusive snus users (p = 0.03). A history of tobacco use, even exclusive use of the seemingly benign snus, is associated with moderately increased cancer-specific mortality. Although nicotine might play a role, the mechanisms warrant further investigation.

Bavara JH, Tae H, Settlage RE, Garner HR. Characterizing the Genetic Basis for Nicotine Induced Cancer Development: A Transcriptome Sequencing Study. PLoS One 2013; Jun 18  [Full text]

Abstract: Nicotine is a known risk factor for cancer development and has been shown to alter gene expression in cells and tissue upon exposure. We used Illumina® Next Generation Sequencing (NGS) technology to gain unbiased biological insight into the transcriptome of normal epithelial cells (MCF-10A) to nicotine exposure. We generated expression data from 54,699 transcripts using triplicates of control and nicotine stressed cells. As a result, we identified 138 differentially expressed transcripts, including 39 uncharacterized genes. Additionally, 173 transcripts that are primarily associated with DNA replication, recombination, and repair showed evidence for alternative splicing. We discovered the greatest nicotine stress response by HPCAL4 (up-regulated by 4.71 fold) and NPAS3 (down-regulated by -2.73 fold); both are genes that have not been previously implicated in nicotine exposure but are linked to cancer. We also discovered significant down-regulation (-2.3 fold) and alternative splicing of NEAT1 (lncRNA) that may have an important, yet undiscovered regulatory role. Gene ontology analysis revealed nicotine exposure influenced genes involved in cellular and metabolic processes. This study reveals previously unknown consequences of nicotine stress on the transcriptome of normal breast epithelial cells and provides insight into the underlying biological influence of nicotine on normal cells, marking the foundation for future studies.

Cardinal A, Nastrucci C, Cesario A, Russo P. Nicotine: specific role in angiogenesis, proliferation and apoptosis. Critical Reviews in Toxicology, 2012; 42(1): 68–89

Abstract: Nowadays, tobacco smoking is the cause of ~5-6 million deaths per year, counting 31% and 6% of all cancer deaths (affecting 18 different organs) in middle-aged men and women, respectively. Nicotine is the addictive component of tobacco acting on neuronal nicotinic receptors (nAChR). Functional nAChR, are also present on endothelial, haematological and epithelial cells. Although nicotine itself is regularly not referred to as a carcinogen, there is an ongoing debate whether nicotine functions as a ‘tumour promoter’. Nicotine, with its specific binding to nAChR, deregulates essential biological processes like regulation of cell proliferation, apoptosis, migration, invasion, angiogenesis, inflammation and cell-mediated immunity in a wide variety of cells including foetal (regulation of development), embryonic and adult stem cells, adult tissues as well as cancer cells. Nicotine seems involved in fundamental aspects of the biology of malignant diseases, as well as of neurodegeneration. Investigating the biological effects of nicotine may provide new tools for therapeutic interventions and for the understanding of neurodegenerative diseases and tumour biology.

Momi N, Kaur S, Ponnusamy MP, Kumar S, Wittel UA, Batra SK. Interplay between smoking-induced genotoxicity and altered signaling in pancreatic carcinogenesis. Carcinogenesis. 2012 Sep;33(9):1617-28.  [full text]

Abstract: Despite continuous research efforts directed at early diagnosis and treatment of pancreatic cancer (PC), the status of patients affected by this deadly malignancy remains dismal. Its notoriety with regard to lack of early diagnosis and resistance to the current chemotherapeutics is due to accumulating signaling abnormalities. Hoarding experimental and epidemiological evidences have established a direct correlation between cigarette smoking and PC risk. The cancer initiating/promoting nature of cigarette smoke can be attributed to its various constituents including nicotine, which is the major psychoactive component, and several other toxic constituents, such as nitrosamines, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone, and polycyclic aromatic hydrocarbons. These predominant smoke-constituents initiate a series of oncogenic events facilitating epigenetic alterations, self-sufficiency in growth signals, evasion of apoptosis, sustained angiogenesis, and metastasis. A better understanding of the molecular mechanisms underpinning these events is crucial for the prevention and therapeutic intervention against PC. This review presents various interconnected signal transduction cascades, the smoking-mediated genotoxicity, and genetic polymorphisms influencing the susceptibility for smoking-mediated PC development by modulating pivotal biological aspects such as cell defense/tumor suppression, inflammation, DNA repair, as well as tobacco-carcinogen metabolization. Additionally, it provides a large perspective toward tumor biology and the therapeutic approaches against PC by targeting one or several steps of smoking-mediated signaling cascades.

Petros WP, Younis IR, Ford JN, Weed SA. Effects of tobacco smoking and nicotine on cancer treatment. Pharmacotherapy. 2012 Oct;32(10):920-31

Abstract: A substantial number of the world’s population continues to smoke tobacco, even in the setting of a cancer diagnosis. Studies have shown that patients with cancer who have a history of smoking have a worse prognosis than nonsmokers. Modulation of several physiologic processes involved in drug disposition has been associated with long-term exposure to tobacco smoke. The most common of these processes can be categorized into the effects of smoking on cytochrome P450-mediated metabolism, glucuronidation, and protein binding. Perturbation in the pharmacokinetics of anticancer drugs could result in clinically significant consequences, as these drugs are among the most toxic, but potentially beneficial, pharmaceuticals prescribed. Unfortunately, the effect of tobacco smoking on drug disposition has been explored for only a few marketed anticancer drugs; thus, little prescribing information is available to guide clinicians on the vast majority of these agents. The carcinogenic properties of several compounds found in tobacco smoke have been well studied; however, relatively little attention has been given to the effects of nicotine itself on cancer growth. Data that identify nicotine’s effect on cancer cell apoptosis, tumor angiogenesis, invasion, and metastasis are emerging. The implications of these data are still unclear but may lead to important questions regarding approaches to smoking cessation in patients with cancer.

Catassi A, Servent S, Paleari L, Cesario A, Russo P. Multiple roles of nicotine on cell proliferation and inhibition of apoptosis: implications on lung carcinogenesis. Mutat Res. 2008 Sep-Oct;659(3):221-31.

Abstract: The genotoxic effects of tobacco carcinogens have long been recognized, the contribution of tobacco components to cancerogenesis by cell surface receptor signaling is relatively unexplored. Nicotine, the principal tobacco alkaloid, acts through nicotinic acetylcholine receptor (nAChR). nAChR are functionally present on human lung airway epithelial cells, on lung carcinoma [SCLC and NSCLC] and on mesothelioma and build a part of an autocrine-proliferative network that facilitates the growth of neoplastic cells. Different nAChR subunit gene expression patterns are expressed between NSCLC from smokers and non-smokers. Although there is no evidence that nicotine itself could induce cancer, different studies established that nicotine promotes in vivo the growth of cancer cells and the proliferation of endothelial cells suggesting that nicotine might contribute to the progression of tumors already initiated. These observations led to the hypothesis that nicotine might be playing a direct role in the promotion and progression of human lung cancers. Here, we briefly overview the role and the effects of nicotine on pulmonary cell growth and physiology and its feasible implications in lung carcinogenesis.

Slotkin TA. If nicotine is a developmental neurotoxicant in animal studies, dare we recommend nicotine replacement therapy in pregnant women and adolescents? Neurotoxicol Teratol. 2008 Jan-Feb;30(1):1-19.

Abstract: Tobacco use in pregnancy is a leading cause of perinatal morbidity and contributes in major ways to attention deficit hyperactivity disorder, conduct disorders and learning disabilities that emerge in childhood and adolescence. Over the past two decades, animal models of prenatal nicotine exposure have demonstrated that nicotine is a neurobehavioral teratogen that disrupts brain development by preempting the natural, neurotrophic roles of acetylcholine. Through its actions on nicotinic cholinergic receptors, nicotine elicits abnormalities of neural cell proliferation and differentiation, promotes apoptosis and produces deficits in the number of neural cells and in synaptic function. The effects eventually compromise multiple neurotransmitter systems because of the widespread regulatory role of cholinergic neurotransmission. Importantly, the long-term alterations include effects on reward systems that reinforce the subsequent susceptibility to nicotine addiction in later life. These considerations strongly question the appropriateness of nicotine replacement therapy (NRT) for smoking cessation in pregnant women, especially as the pharmacokinetics of the transdermal patch may actually enhance fetal nicotine exposure. Further, because brain maturation continues into adolescence, the period when smoking typically commences, adolescence is also a vulnerable period in which nicotine can change the trajectory of neurodevelopment. There are also serious questions as to whether NRT is actually effective as an aid to smoking cessation in pregnant women and adolescents. This review considers the ramifications of the basic science findings of nicotine’s effects on brain development for NRT in these populations.

Egleton RD, Brown KC, Dasgupta P. Nicotinic acetylcholine receptors in cancer: multiple roles in proliferation and inhibition of apoptosis. Trends Pharmacol Sci. 2008 Mar;29(3):151-8.

Abstract: Nicotinic acetylcholine receptors (nAChRs) constitute a heterogeneous family of ion channels that mediate fast synaptic transmission in neurons. They have also been found on non-neuronal cells such as bronchial epithelium and keratinocytes, underscoring the idea that they have functions well beyond neurotransmission. Components of cigarette smoke, including nicotine and NNK [4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone], are agonists of nAChRs. Given the association of tobacco use with several diseases, the non-neuronal nAChR signaling pathway has considerable implications for cancer and cardiovascular disease. Recent studies have shown that alpha7 is the main nAChR subunit that mediates the proliferative effects of nicotine in cancer cells. As a result, alpha7 nAChR might be a valuable molecular target for therapy of cancers such as lung cancer and mesothelioma. Future studies involving the design of nAChR antagonists with improved selectivity might identify novel strategies for the treatment of tobacco-related cancers. Here we review the cellular roles of non-neuronal nAChRs, including regulation of cell proliferation, angiogenesis, apoptosis, migration, invasion and secretion.

Zeilder R, Albermann K, Lang S. Nicotine and apoptosis. Apoptosis. 2007 Nov;12(11):1927-43.

Abstract: Cigarette smoking is associated with a plethora of different diseases. Nicotine is the addictive component of cigarette but also acts onto cells of the non-neuronal system, including immune effector cells. Although nicotine itself is usually not referred to as a carcinogen, there is ongoing debate whether nicotine functions as a ‘tumor enhancer.‘ By binding to nicotinic acetylcholine receptors, nicotine deregulates essential biological processes like angiogenesis, apoptosis, and cell-mediated immunity. Apoptosis plays critical roles in a wide variety of physiologic processes during fetal development and in adult tissue and is also a fundamental aspect of the biology of malignant diseases. This review provides an overlook how nicotine influences apoptotic processes and is thus directly involved in the etiology of pathological conditions like cancer and obstructive diseases.

 Wickström R. Effects of nicotine during pregnancy: human and experimental evidence. Curr Neuropharmacol. 2007 Sep;5(3):213-22. [full text]

Abstract: Prenatal exposure to tobacco smoke is a major risk factor for the newborn, increasing morbidity and even mortality in the neonatal period but also beyond. As nicotine addiction is the factor preventing many women from smoking cessation during pregnancy, nicotine replacement therapy (NRT) has been suggested as a better alternative for the fetus. However, the safety of NRT has not been well documented, and animal studies have in fact pointed to nicotine per se as being responsible for a multitude of these detrimental effects. Nicotine interacts with endogenous acetylcholine receptors in the brain and lung, and exposure during development interferes with normal neurotransmitter function, thus evoking neurodevelopmental abnormalities by disrupting the timing of neurotrophic actions. As exposure to pure nicotine is quite uncommon in pregnant women, very little human data exist aside from the vast literature on prenatal exposure to tobacco smoke. The current review discusses recent findings in humans on effects on the newborn of prenatal exposure to pure nicotine and non-smoke tobacco. It also reviews the neuropharmacological properties of nicotine during gestation and findings in animal experiments that offer explanations on a cellular level for the pathogenesis of such prenatal drug exposure. It is concluded that as findings indicate that functional nAChRs are present very early in neuronal development, and that activation at this stage leads to apoptosis and mitotic abnormalities, a total abstinence from all forms of nicotine should be advised to pregnant women for the entirety of gestation.

Grozio A, Catassi A, Cavalieri Z et al Nicotine, lung and cancer. Anticancer Agents Med Chem. 2007 Jul;7(4):461-6.

Abstract: The respiratory epithelium expresses the cholinergic system including nicotinic receptors (nAChRs). It was reported that normal human bronchial epithelial cells (BEC), which are the precursor for squamous cell carcinomas, and small airway epithelial cells (SAEC), which are the precursor for adenocarcinomas, have slightly different repertoires of nAChRs. Studies show that nAChRs expressed on lung carcinoma or mesothelioma form a part of an autocrine-proliferative network facilitating the growth of neoplastic cells; others demonstrated that nicotine can promote the growth of colon, gastric, and lung cancers. Nicotine and structurally related carcinogens like NNK [4-(methylnitrosoamino)- 1-(3-pyridyl)-1-butanone] and NNN (N’-nitrosonornicotine) could induce the proliferation of a variety of small cell lung carcinoma cell lines and endothelial cells and nicotine in non-neuronal tissues -including lung- induces the secretion of growth factors (bFGF, TGF-alpha, VEGF and PDGF), up regulation of the calpain family proteins, COX-2 and VEGFR-2, causing the eventual activation of Raf/MAPK kinase/ERK (Raf/MEK/ERK) pathway contributing to the growth and progression of tumors exposed to nicotine through tobacco smoke or cigarette substitutes. It has been demonstrated that nicotine promotes the growth of solid tumors in vivo, suggesting that might induce the progression of tumors already initiated. While tobacco carcinogens can initiate and promote tumorigenesis, the exposure to nicotine could confer a proliferative advantage to early tumors but there is no evidence that nicotine itself provokes cancer. This is supported by the findings that nicotine can prevent apoptosis induced by various agents – such as chemotherapeutic in NSCLC, conferring a survival advantage as well.

All a conspiracy: anti-mobile phone fruitcake argues that all university research toes government cover-up line on 5G dangers

In 2016, I published with three cancer epidemiologists and biostatisticians, a paper that examined age and gender specific incidence rates of 19,858 male and 14,222 females diagnosed with brain cancer in Australia between 1982 and 2012, and mobile phone usage data from 1987 to 2012. We modelled expected age specific brain cancer rates (20–39, 40–59, 60–69, 70–84 years), based on published reports from case-control studies of relative risks (RR) of 1.5 (a 50% increase) in ever-users of mobile phones, and RR of 2.5 in a proportion of ‘heavy users’ (19% of all users), assuming a 10-year lag period between commencement of use and new cancer incidence.

We found no increases in the rates of brain cancer for any age group other than those aged 70+, but the increases in this age group commenced in the years before mobile phones were available in Australia. We concluded: “The observed stability of brain cancer incidence in Australia between 1982 and 2012 in all age groups except in those over 70 years compared to increasing modelled expected estimates, suggests that the observed increases in brain cancer incidence in the older age group are unlikely to be related to mobile phone use. Rather, we hypothesize that the observed increases in brain cancer incidence in Australia are related to the advent of improved diagnostic procedures when computed tomography and related imaging technologies were introduced in the early 1980s.”

Our results were consistent with studies showing the same lack of increase in the USA, New Zealand, the UK and the Nordic countries (see our paper for the references). A more fine-grained analysis of the Australian data published this year confirmed our findings

The Blue Mountains City Council west of Sydney, is currently being implored by  a small group of residents to somehow stop 5G mobile telephony coming to the area. I received requests for information from a councillor and “replied all” to a very long recipient list which I soon found out contained at least one anti 5G activist who soon got busy over several emails sending me a predictable litany of reasons why our study should be heavily discounted. I suggested that she might like to put her points in formal correspondence to Cancer Epidemiology, the journal which published our paper.

A fishy sociologist, employed by a university, funded by government favouring 5G

Sociologists strike

But I was highly amused by a section of her email that threw down triple gauntlets that a social scientist like me was not a “scientist”, that my work was “fishy” because I had once had a small grant from the mobile phone industry (21 years ago) to investigate the life-saving use of mobiles in emergency situations, and that I worked for a government-funded university and the government was supporting 5G.

She wrote:

“If you are a sociologist, which please understand is a noble profession, I am just wondering if that qualified you to be doing scientific research as when people find out you are a sociologist, wouldn’t that sort of take away a bit of credibility?

I am a little skeptical as to why you would do a research paper about phones use and brain cancers when you do say you did not get any funding for it (even though you have been funded before by Telcos for what i would regard as a large amount, if $23,895). Do you agree that people might think this is a little bit fishy, especially when you are not even a scientist but a sociologist. Even though you say you were not funded, aren’t you paid by the University which is in effect partially funded by the Federal Govt, which is pro 5G. So, even though you are not directly funded, you indirectly are by a group that is pro 5G. Sorry, this seems glaringly obvious to me but I may be wrong. Also, doesn’t it mean that your research is not really independent and you should be saying that rather than say you were not funded.?”

I replied:

“Your insinuation that my research was not independent is frankly offensive and profoundly silly. I repeat, it was NOT funded by anyone as funding was not necessary to simply analyse publicly available data.

If you or your associates were to repeat that in public, you would be making false and defamatory remarks. That would include any circulation of such comments by email which come to my attention.

The implication of your argument that, because I got  my salary from the government, that no one in a research institution that receives government funding can ever produce independent research on any matter because it somehow all reflects government policy, and, what … we all have our work scrutinized by an Orwellian committee to make sure it conforms to particular government policy (on here, 5G?) is beyond ludicrous.

You may be unaware, but I have spent most of my career researching and advocating for policy reforms in many areas (gun control, tobacco control, renewable energy etc ie: trying to get government policy changed). I have often been highly critical of government policy and governments.

So how do you begin to explain that I’ve had many government research grants, awards etc, if the research game is all about producing policy conforming research outputs that never challenge government policy?

This sails very close to conspiracy theory about universities researchers all being puppets of governments (which change far more often than many staff do in universities).  If that is your thing, I have nothing further to say to someone who seems attracted to such claptrap.

Similarly, your statement ‘you are not a scientist but a sociologist’ and your question ‘I am just wondering if that qualified you to be doing scientific research as when people find out you are a sociologist, wouldn’t that sort of take away a bit of credibility?’ are similarly offensive.

They suggest you are quite ignorant of what research is and the multi-disciplinary nature of research across all complex fields in medicine today.  I am an elected fellow of the Australian Academy of Social Science. The three other authors on my paper are all cancer epidemiologists. In 2008, I won the NSW Premier’s Cancer Researcher of the Year. My AO citation is  “for distinguished service to medical research as an academic and author, particularly in the area of public health policy, and to the community.”

A couple of weeks later, she replied, refusing to let go of her conspiracist bone:

“My apologies. You do work for the university and most people who have a degree of wisdom know that there is an increasing amount of control over university academia. One just has to look at the decreasing numbers of undergraduate studies to confirm this and the attacks against academics that may speak their mind. Whilst some free thinking academics remain, they are decreasing.”

In a paper I co-authored in 1998 looking at common themes in press reportage of anti-vaccination advocates, we identified cover up of vaccine risks by an unholy alliance of conspiracists in government, science and the pharmaceutical industry as dominant themes. It’s a meme which has a long history, invoked without fail by any interest group which fails to win arguments based on evidence. “All these reports are published by a global cabal of conspirators who push particular lines and suppress others. We are today’s Galileo’s speaking out against the modern church of science!” they plead.

The idea that universities in open societies have mechanisms that ensure all their staff never investigate or publish on any research question which might upset government or business interests is beyond preposterous and contradicted by oceans of examples across all fields of research. Those who persist in peddling this massively ignorant bilge deserve to have 10,000watt arc lights trained on their nonsense.

 

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