At the beginning of August, Steve and I were invited down to Wellington to speak about AVCA, present copies of AVCA Policies and Procedures and answer questions as presented to us with regards to electronic cigarettes, nicotine e-liquid and ENDS use.

We were told that we were invited because of the work in our Vape It Forward Program, as well as a recommendation that came from the community to the minister that we were community advocates, helping to educate not just individuals but also smoking cessation providers in the area and were “onto it” when it came to explaining what vaping was and how we are involved in our local communities.

The minister was impressed that we were not affiliated with the industry and as an all volunteer organisation that has no vested financial interest in vaping.   The minister was impressed that we were willing to share our information, knowledge and assist in collaborating in the legalisation process for no other reason than we feel it is the the right thing to do, and that knowledge, information and experience is to be shared for the benefit of the whole community.

Below, please find a copy of the document that we were asked to create to submit to MP Coleman and the Health Committee as it relates to the “big three” concerns that are/were held at the time of our meeting;  Nicotine toxicity/carcinogenicity; youth gateway effect and second hand vape exposure.

INTRODUCTION:

The policy document states the objectives that the Ministry of Health hopes that the submission phase of the process towards legalising nicotine containing e-liquid will help to clarify.  The main emphasis is how there may be reduction from harm from tobacco smoking through the use of nicotine containing e-cigarettes (ENDS).

From perusal of the policy document and a consultation with a minister in Wellington,  the “big three” concerns held by the Ministry of Health were outlined as: the toxicity of nicotine, the effect of the use of ENDS on youth smoking and exposure – aka “The Gateway Effect” and the effects of ENDS on others.

BACKGROUND:

In order to review the science that is available, one must first understand about science and scientific method and then be aware of the source of the funding of the scientific research.

With regards to science and scientific method, I am going to make three presumptions:  the first that it is common knowledge that Science is “a systematic and logical approach to discovering how things in the universe work. It is also the body of knowledge accumulated through the discoveries about all the things in the universe.”; the second  we know the word “science” is derived from the Latin word scientia, which is knowledge based on demonstrable and reproducible data and, lastly that the scientific method is utilised to “collect measurable, empirical evidence in an experiment related to a hypothesis (often in the form of an if/then statement), the results aiming to support or contradict a theory.” (1)

The scientific method:

  1. Make an observation or observations; ask questions about the observations and gather information;
  2. Form a hypothesis — a tentative description of what’s been observed, and make predictions based on that hypothesis;
  3. Test the hypothesis and predictions in an experiment that can be reproduced;
  4. Analyze the data and draw conclusions; accept or reject the hypothesis or modify the hypothesis if necessary;
  5. Reproduce the experiment until there are no discrepancies between observations and theory.

It is of paramount importance to keep the concept of “good science” in mind when deciding which studies are best for evidence to address the concerns that are presented by the Ministry of Health in the policy surrounding nicotine e-liquid and nicotine containing ENDS.  A review of the policy document leads us to believe that this particular document has taken some of its guidance from the FDA Deeming regulations and the TPD from the EU.

How and why Research is Funded in the US & EU – The simple version:

Most of the “first tier” medical research projects and longitudinal studies that are funded in the United States come through the National Institutes of Health and their various subsections (NCI, NIDDK, NIMH, etc. – for the specific area of the human body that the research relates to) and are funded by their priority on the federal register and public health concerns (Put simply, diabetes research will be funded to prevent diabetes – some projects may focus on obesity and endocrinology, some diabetes research will focus on obesity and dietary factors, some diabetes research will focus on genetic factors & causes.)  .  The projects are given priority according to federal public health priorities but the funding itself comes from the health budget targets, private donations/foundations and taxes on “public health harms” such as those excises on tobacco, alcohol and “sugar tax” on food products.

“Second tier” funding comes from the “charities” that receive funding from their sponsors (American Cancer Society, American Lung Association, etc.) who have a specific bias towards preventing the diseases that they are affiliated with.  Funding comes from donations from the public as well as donations from private corporations (including tobacco and pharmaceutical companies as “alms” for the harms their products can cause in the former case, and for the discovery of new products that may perhaps benefit to their profit margins in the latter case should a marketable discovery be made.)

“Third tier” funding is that which is funded through private foundations setup for philanthropic causes that are near and dear to the founders of said foundation.

None of the foregoing is an indictment on the researchers who apply for funding, but they do know which way to go (1st,2nd,3rd tier) and which organisation to apply to for the best chance of funding. (Most new researchers start with 3rd and work their way up to 1st).  They also know how to present their hypothesis & methods to suit the particular funders requirements.  Some of those requirements are in “black and white” and others are more “between the lines.”  In academic research, as I am sure Dr. Coleman knows, it truly is a matter of “publish or perish”, so funding is a priority.

Where research Happens in the United States & EU:

Most research happens in the bigger Universities – both public and private.   Some also occurs in the bigger privately funded “think tanks” and “foundations.”   Researchers at these institutions are usually hired because they fit the “research game plan” for the particular institution and then need to keep in mind the mission statement and goals of the particular institution they work for.   As well, those mission statements and goals need to be in line with the local prevailing public health goals and focus that the Dean of Medicine chooses for the research.  Again, keeping in mind the “publish or perish” scenario, the “sexy science focii” are those topical areas of interest within the parameters set by the people who run the medical school/research facilities.

  1. Negative Bias in Research as it relates specifically to Electronic Cigarettes:

Assessing all the foregoing, it is easy to see that any scientific research coming out of the United States is going to be institutionally biased towards the tobacco and pharmaceutical industries.   Electronic cigarettes/ENDS are a “disruptive technology” as they disrupt the status quo and the processes by which revenue and profits are generated and therefore, are a threat to that same status quo.   Hence the most effected concerns see ENDS as a threat.  Part of the reason is the revenue and profits that are generated from the products produced by the tobacco and pharmaceutical industries that contribute to the federal and local economies in the United States.    As more people switch to vaping from combustible tobacco smoking, there is a major loss of revenue to government tax bases and lack of funding towards those projects that require that money to continue. As far as the pharmaceutical industry is concerned, they too are losing profits as more people switch to vaping in lieu of their products for smoking cessation – patches, gum, lozenges and medicinal compounds such as Zyban, Champix, etc.  It is believed that the foregoing were the reasons for the push by the FDA to initiate and implement the Deeming Regulations regarding ENDS – to protect tax revenue and corporate profits, NOT in the interests of public health, referencing biased science to prove their case.

In Europe, as it relates to the TPD, it is a well known fact that there were representatives on the committee that devised and implemented those regulations – specifically Pfizer Glaxo Smith Kline (GSK) and they had major influence on the proceedings as can be seen here.

Finishing with the reality that there are ethical issues within the scientific community as well – some associated with the “publish or perish” mantra and others associated with undue influence from funding sources/sponsor.   In one study done overseas that reviewed and surveys researchers globally, one in seven scientists said that they are aware of colleagues having seriously breached acceptable conduct by inventing results. And around 46 per cent say that they have observed fellow scientists engage in “questionable practices”, such as presenting data selectively or changing the conclusions of a study in response to pressure from a funding source.  Interestingly,  misconduct was far more frequently admitted by medical or pharmacological researchers than others, supporting fears that the field of medical research is being biased by commercial interests.  (2)

Summarised:  Research on ENDS that comes from the United States and the EU, especially from the former –  needs to be approached cautiously for its veracity and its ethical underpinnings.  This is not to say that research should not be considered from the United States particularly, but that research from there may be unduly influenced by commercial interests and profits – the protection thereof, as well as professional investment (scientists, some not all) and government revenue (protection of same) are the driving force behind much of the “science” as it relates to ENDS.  There are quite a few researchers in both the United States (Michael Siegel, PhD from Boston University) and the EU (Konstantinos Farsolinos, MD and his team at the Onassis Research institute in Athens) that not only conduct their own research, but review the research from around the world for its validity based on scientific method, ethical standards and process of funding.

NEW ZEALAND MINISTRY OF HEALTH CONCERNS – The Big Three

DISCUSSION: 

Nicotine – carcinogenicity, toxicity and harms:Nicotine is a widely used addictive substance, which has a psychoactive effect and can be lethal in large quantities.  On the other hand, the long-term use of small quantities of nicotine in approved nicotine replacement therapy (NRT) products (such as gum, patches or lozenges) is considered to be safe.

The reference utilised by MoH to the justify above statement comes from a journal article that was a review of previous scientific articles with an emphasis on, as is in the title “dubious self-experiments in the nineteenth century.”  Accordingly, In the policy document, MoH references that  “The medium lethal dose is estimated to range between 6.5 and 13 mg/kg.” (6).  Current science disproves these figures and results, as discussed below.

Nicotine is no more addictive than that of the caffeine contained in coffee and tea. (9). Although nicotine is the main psychoactive agent in tobacco, it has relatively minor health effects –  It is not a carcinogen, does not cause respiratory disease and has only minor cardiovascular effects. (3) Also, the nicotine used in ENDS, while it may contain small amounts of other chemicals including volatile organic compounds, carbonyls, aldehydes, tobacco-specific nitrosamines (TSNAs) and metal particles, research indicates that they are present at much lower levels than in cigarette smoke. (4)  In normal conditions of use, toxin levels in inhaled ENDS aerosol are below prescribed threshold limit values for occupational exposure, in which case significant long-term harm is unlikely. (5)

Lethal overdose of nicotine is rare as nicotine itself is an emetic and any ingestion of liquid nicotine diluent, such as that used for ENDS would result in vomiting. (7,8,9).  This also coincides with the issues the ministry holds regarding “dual use” of ENDS with combustible tobacco, that it may cause harm does not take into account the concept of “reduced harm”  There is no evidence of increased nicotine intake from dual use.  Smokers regulate their smoking behaviour in order to maintain the blood concentrations of nicotine within a comfortable range.  If those levels get too high, symptoms of nicotine toxicity – such as nausea, headache and dizziness can occur and smoking is then reduced.   A recent study found that smokers using ENDS maintain their intake of nicotine, but reduce their smoke and toxin intake, which results in an overall health benefit, therefore reducing harm through reducing exposure to the toxicants in combustible tobacco (10).  It is extremely difficult for someone to have a fatal overdose of nicotine through either ENDS use or through ingesting nicotine containing e-liquid due to nicotine’s inherent emetic qualities.

Promotion to young people:  Overseas evidence shows that promotion of e-cigarettes targeting young people through flavours, packaging may appeal to young people.   Local evidence that there is an increase in New Zealand youth trying e-cigarettes from studies in 2014 that DID NOT NOTE whether said use was with nicotine containing e-liquid or non-nicotine e-liquid.

The main issue with youth is harm reduction.  One cannot, in an unequivocal manner state that they can prevent youth from uptake or experimentation with any harmful substance of behaviour with 100% guarantee. “Common Liability”, as discussed by Bell and Keane, as it relates to the “gateway theory” defines this as the association between youth who are more risk takers and attracted to experimentation and more likely to try anything that seems to be “taboo” be it ENDS, alcohol, drugs, etc. (11).

With regards to the uptake of “vaping” in previously non-smoking youth, the available evidence does not support the “gateway hypothesis” that ENDS encourages nicotine addiction or uptake by youth.  In the UK, daily ENDS use in youth is almost exclusively confined to those who already use combustible tobacco daily and regularly.  Less than .2% of youth who have never smoked combustible tobacco have taken up vaping and there is no evidence of progression to smoking in this cohort. (12,13)

Keeping this in mind, as far as harm reduction and youth:  nicotine dependence in youth develops rapidly and over 50% of those youth who smoke daily are already nicotine dependent.   Young people who are already smoking can reduce their harm by switching to ENDS by 95%, as was shown in the Public Health UK Report.

Impact of vaping on others:   “vaping clouds may be a nuisance to others, especially in enclosed spaces” and “could have negative health impacts.”

With regards to second hand exposure concerns, the ministry needs to look again at the Public Health UK report that they referenced in their policy document.  Contained therein is a review that passive exposure to vapour have generally concluded that the risk to bystanders is very small and that Public Health England found that “ENDS release negligible levels of nicotine into ambient air with no health risks to bystanders.”(14,15)­

As far as the argument that “vaping clouds could be a nuisance to others especially in enclosed spaces”, unless the government also wishes to regulate the use of body sprays, perfumes, and deodorants which are also a nuisance – and can be a health hazard to those who have respiratory difficulties and disease (unlike second hand vapour which has NO health harms associated with it (15,16) therefore this argument is not valid.

CONCLUSION:

his document we have covered the process of ENDS research as it is conducted in the United States and in Europe, outlining the questions that need to be asked of any science on this topic due to the insidious influence of both tobacco and pharmaceutical concerns on the subject.   In the environment of academic research, there still exists the “publish or perish” mentality which means that at times, researchers must approach their hypotheses and research methods to coincide with the funding providers point of view and/or their institutions mission statements and funding sources.   This is a reality at all research institutions worldwide, regardless of the topic.

When looking at the research and information on ENDS from a Public Health perspective, one needs to weigh the same five criteria that the Ministry utilised in their Drug Utensils policy document:  Harm Prevention, Harm Reduction, Proportionality, Ease of Implementation and Cost Effectiveness.   It is in the spirit of this point of view that we at AVCA have addressed the foregoing and will be utilising in our submission on Nicotine E Liquid and ENDS products submission that we will make in September in response to the Ministry.

Thank you for the opportunity to provide you with this information and should you require more in depth information or explanation, please do not hesitate to contact us as we wish to work with the Ministry on this process.

REFERENCES/BIBLIOGRAPHY:

  1. Bradford, A. (2015, March 30). Science & the Scientific Method: A Definition. Retrieved August 08, 2016, from http://www.livescience.com/20896-science-scientific-method.html
  2. Fanelli, D. (2009, May 29). How Many Scientists Fabricate and Falsify Research? A Systematic Review and Meta-Analysis of Survey Data. Retrieved August 08, 2016, from http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0005738
  3. Bell K, Keane H. All gates lead to smoking: the ‘gateway theory’, e-cigarettes and the remaking of nicotine. Soc Sci Med. 2014;119:45-52.
  4. Zwar N, Bell J, Peters M, Christie M, Mendelsohn C. Nicotine and nicotine replacement therapy – the facts. Australian Pharmacist. 2006;25(12):969-73
  5. Goniewicz ML, Knysak J, Gawron M et al. Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Tob Control. 2014;23(2):133-9
  6. Burstyn I. Peering through the mist: systematic review of what the chemistry of contaminants in electronic cigarettes tells us about health risks. BMC Public Health. 2014;14(1):18
  7. Mayer B. How much nicotine kills a human? Tracing back the generally accepted lethal dose to dubious self-experiments in the nineteenth century. Arch Toxicol. 2014;88(1):5-7
  8. Christensen L. Three cases of attempted suicide by ingestion of nicotine liquid used in e-cigarettes. Clinical Toxicology. 2013;51:290
  9. Schipper EM, de Graaff LC, Koch BC et al. A new challenge: suicide attempt using nicotine fillings for electronic cigarettes. Br J Clin Pharmacol. 2014;78(6):1469-71
  10. Misra, M., Leverette, R., Cooper, B., Bennett, M., & Brown, S. (2014). Comparative In Vitro Toxicity Profile of Electronic and Tobacco Cigarettes, Smokeless Tobacco and Nicotine Replacement Therapy Products: E-Liquids, Extracts and Collected Aerosols. International Journal of Environmental Research and Public Health IJERPH,11(11), 11325-11347. doi:10.3390/ijerph111111325
  11. McRobbie H, Phillips A, Goniewicz ML et al. Effects of Switching to Electronic Cigarettes with and without Concurrent Smoking on Exposure to Nicotine, Carbon Monoxide, and Acrolein. Cancer Prev Res (Phila). 2015;8(9):873-8
  12. Rachemacher, L., MD, PhD. (2016). Dopamine Returns to Normal 3 Months After Quitting Smoking | Psych Central News. Retrieved August 08, 2016, from http://psychcentral.com/news/2016/07/31/dopamine-function-returns-to-normal-3-months-after-quitting-smoking/107912.html.
  13. Bell K, Keane H. All gates lead to smoking: the ‘gateway theory’, e-cigarettes and the remaking of nicotine. Soc Sci Med. 2014;119:45-52.
  14. Bauld L, MacKintosh AM, Ford A, McNeill A. E-Cigarette Uptake Amongst UK Youth: Experimentation, but Little or No Regular Use in Non-smokers. Nicotine Tob Res. 2016;18(1):102-3.
  15. Use of electronic cigarettes among children in Great Britain. Action on Smoking and Health, UK, 2015 Contract No.: Fact sheet 34. Available at http://www.ash.org.uk/information/facts-and-stats/fact-sheets (accessed August 2016).
  16. McNeill A, Brose LS, Calder R, Hitchman SC, Hajek P, McRobbie H. E-cigarettes: an evidence update. A report commissioned by Public Health England. PHE publications gateway number: 2015260 2015. Available at https://www.gov.uk/government/publications/e-cigarettes-an-evidence-update (accessed July 2016).
  17. Marco, E., & Grimaldo, J. O. (2015, September 4). A rapid method for the chromatographic analysis of volatile organic compounds in exhaled breath of tobacco cigarette and electronic cigarette smokers. Retrieved August 08, 2016, from http://www.ncbi.nlm.nih.gov/pubmed/26243705
Author

Nancy comes from a diverse administrative background that includes surgical research administration, teaching (primary and tertiary level), executive administration and community property management. For over 15 years she has been very active in community advocacy with youth, lower income folk needing advocacy and now, vaping advocacy. She brings a wealth of scientific, medical and research administrative/management knowledge with her to her role as CEO/Director at AVCA.