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Comment: 

David Nutt et al have recently responded to criticisms regarding there paper, as above.
The following is a response to this response, and it included a link to their Lancet commentary:
<STRONG;From:</strong; Bareham David (LCHS)<STRONG;Sent:</strong; 21 March 2016 11:10<STRONG;To:</strong; '[email protected]'<STRONG;Subject:</strong; Lancet Response.<STRONG;Importance:</strong; High
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Dear Professor Phillips,
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I note, with interest, you and your colleagues response in The Lancet: “E-Cigarettes are less harmful than smoking” ( http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00253-6/fulltext";http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00253-6/fulltext ).
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While, in principle, I do not disagree with the title of this piece, I believe there are some “issues” with the specifics included. I wonder if I may ask some questions regarding the piece, please?
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<LI;Your statement: “The paucity of evidence for serious harm to users of e-cigarettes over the years since they were first marketed in 2006, with millions purchased, in itself is evidence” ignores the fact that it takes significantly longer for <EM;tobacco cigarettes</em; to cause “serious harm” e.g. lung cancer (http://tobaccocontrol.bmj.com/content/21/2/87.full";http://tobaccocontro... ). As Cancer Research UK state, this takes “decades”. Conversely, Professor John Britton has fairly recently confirmed his opinion (at least) that there is a “likely real” potential <EM;for e-cigarettes to cause lung cancer</em; (and COPD, other cancers etc - http://www.e-cigarette-summit.com/files/2015/11/1120-John-Britton.pdf";h... : see the last slide). However, we will not see this occurring, of course, for some time. The statement you make, therefore, appears to ignore what is known about tobacco exposure and the resultant “serious harm” you refer to. Your statement is, arguably, a misleading and irrelevant truism, as <EM;we expect a relative paucity of evidence on serious harm at this stage</em; in the marketing of ENDS. In stark contrast, we have substantial accumulation of scientific data, built up over a century and more, on the harms of tobacco, as per the Tobacco Control link above. However, it took several decades to identify the “serious harms” you allude to. Alternatively, however,&nbsp; are we already seeing the genesis of “serious harm”, in emerging data of ex-vivo assays of e-cigarette users, and negative effects on genes related to pulmonary immunity: https://aaas.confex.com/aaas/2016/webprogram/Paper16208.html";https://aa... ?</li;</ol;
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<LI value="2";The statement “Additionally, biomarkers of potential harm of e-cigarettes are broadly reassuring” is “curious”, in my opinion, as the paper cited (McRobbie et al): <EM;only tested three biomarkers</em;.</li;</ol;
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<LI;The reduction in CO, due to the absence of combustion, is predictable.</li;
<LI;Is the reduction in cotinine necessarily “reassuring”? We know that many devices are http://www.ncbi.nlm.nih.gov/pubmed/24569565";truly inefficient in delivering nicotine, and that this significantly limits their efficacy as potential&nbsp; “tobacco alternatives”. As Professor Robert West has previously stated regarding e-cigarettes: “their popularity among continuing smokers has fallen as they find the devices do not always satisfy their nicotine cravings” (http://www.ft.com/cms/s/0/0c9307e0-ab91-11e4-8070-00144feab7de.html?site... ).</li;
<LI;Moreover, although the reduction in the carbonyl Acrolein in the McRobbie study is ostensibly “reassuring”, this may not be the case for specific, important “susceptible” user populations. For example, the McRobbie paper cites http://onlinelibrary.wiley.com/doi/10.1111/j.1749-6632.2012.06531.x/abst... key review of Acrolein, and its central importance to the pathogenesis of COPD. This paper makes the central observation, regarding Acrolein, that:</li;</ol;
“ . . . <EM;repeated exposure to lower doses</em; represents a risk factor for development of chronic pulmonary inflammation, reduction of host defence, neutrophil inflammation, mucus hypersecretion, and protease mediated lung tissue damage.” (my emphasis)
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One pertinent question appears to be, therefore: is your 95% less harmful than a cigarette assertion really appropriate at all to an individual with established COPD, as you claim, in terms of disease progression (lung function/exacerbation rates)? Of course, we do not know this, as we have no long-term data. However, there is clearly a risk that the devices may simply perpetuate the lung disease
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<LI value="3";Moreover, the fact that the McRobbie paper you cite <EM;only reviews three “biomarkers”</em; is highly relevant to the toxicological Review of Professors Combes and Balls, as attached, for your information. As the authors state, regarding the PHE Report and the Nutt et al study, both:</li;</ol;
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“. . . ignore(s) the possibilities that users might be repeatedly exposed to hitherto undetected contaminants and by-products, as well as to carcinogenic chemicals, or their precursors (which have been detected in solvent extracts and vapours, and which are derived from tobacco during solvent extraction or generated during solvent heating), that can have effects at very low dose levels, following repeat exposures, which can occur without clear threshold doses, thus necessitating zero-dose extrapolation.”
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For example, repeat, low dose exposure to: flavourants, shown to http://ehp.niehs.nih.gov/15-10185/";cause chronic lung disease , or be http://www.sciencedirect.com/science/article/pii/S0887233313002610";cyto... , or http://thorax.bmj.com/content/early/2016/01/08/thoraxjnl-2015-207895";cause airway irritation; http://www.ncbi.nlm.nih.gov/pubmed/26244921";highly reactive oxygen species/free radicals; http://www.ncbi.nlm.nih.gov/pubmed/24832759";carbonyls/Aldehydes and http://www.medscape.com/medline/abstract/26406602";metals are, for example, all issues that the McRobbie et al paper fails to review. This specific failure to review is pertinent to your original study, also, as these papers were all published: <EM;subsequent</em; to it.
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Until these studies are undertaken, as Combes and Balls argue, it is impossible “to perform any sort of risk assessment of the type normally undertaken for consumer products”, and until suitable data is available, it is argued, the claim that electronic cigarettes are “low risk” devices is “reckless and irresponsible” (Combes and Balls, 2016). I am very interested to hear your views on their/this analysis?
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<LI value="4";It appears that the “experts” recruited in your study were/are all advocates of the “Tobacco Harm Reduction”: is this correct? Do you believe that a different assessment result would have been reached with collaboration from other experts, whose approach would have been more “Precautionary”? This issue strikes clearly at the validity and repeatability of the paper you were involved in. I am not at all surprised that there were “few disagreements” between the experts selected, as their philosophy of approach to the topic was the same.</li;</ol;
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<LI value="5";As you are aware, the <EM;funding </em;of your paper has received http://researchonline.lshtm.ac.uk/2305244/1/bmj.h4863.full.pdf";intense scrutiny. You state that “We were informed by EuroSwiss Health (Trélex, Switzerland) that they do not receive funding from any tobacco or e-cigarette manufacturers.” http://www.theguardian.com/society/2015/aug/28/public-health-england-und... is reported the CEO for this organisation is Dr Delon Human, http://www.swissguide.ch/fr/Medecin/Trelex/1146852_euroswisshealthsa.htm... indeed, on further investigation, there is evidence that this is so. There is evidence that Dr Human’s http://www.nicolife.biz/about-us/";other businesses, at the same address as EuroSwiss Health’s , have received http://www.tobaccotactics.org/index.php/Delon_Human";funds from British American Tobacco, as confirmed previously by Dr Human himself. The link between Euro Swiss Health, Dr Human and BAT is clearly magnified further here http://www.bat.com/group/sites/UK__9D9KCY.nsf/vwPagesWebLive/DO964UGU/$file/A_Focus_on_Harm_Reduction_Report_2013.pdf";http://www.bat.com/group/sites/UK__9D9KCY.nsf/vwPagesWebLive/DO964UGU/$file/A_Focus_on_Harm_Reduction_Report_2013.pdf where he stated, <STRONG;<EM;on their behalf</em;</strong;:</li;</ol;
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“Through this public commitment to tobacco harm reduction, the Group makes itself accountable to its consumers and society. This should be applauded and, if successful, BAT could become part of the solution to addressing the epidemic of tobacco-related disease.”
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Please may I ask:
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<LI;How can this possibly be true, when BAT clearly state publically elsewhere that <EM;“Our core business is, and will remain, in tobacco”</em; (http://www.bat.com/nicotine";http://www.bat.com/nicotine )? Their “public commitment to tobacco harm reduction” is, surely, pure sophistry? They invest in http://www.ncsct.co.uk/shopdisp_electronic_cigarette_briefing.php";predo... first-generation, “cig-a-like” devices, that are http://www.ukctas.ac.uk/ukctas/documents/hitchman-et-al-ntr-2015.pdf";not effective as tobacco cessation aids.</li;</ol;
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<LI value="2";Being an “expert” invited to participate in the original study, you are clearly aware of https://bat.library.ucsf.edu/";the scientific deceit undertaken by BAT over the decades: do you believe that BAT, the funders of your paper’s funder’s <EM;other “interests”,</em; are http://www.bat.com/group/sites/UK__9D9KCY.nsf/vwPagesWebLive/DO52ADCY";c... in taking “pride” in this history, as they currently still do?</li;</ol;
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<LI value="3";BAT scientists, involved in e-cigarette “research”, currently claim http://www.sciencedirect.com/science/article/pii/S0887233315001228";“no conflicts of interest” in their papers: do you believe this is the appropriate, or more BAT sophistry? Do you believe that this feature of their declaration has no relevance to your paper?</li;</ol;
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<LI value="4";Would you concur with Professor Robert West when he recently stated: “. . . I think we have to be in no doubt whatsoever the tobacco industry’s job is to sell tobacco and so they are incredibly incentivised to keep people smoking. The fact that they’ve put a toe in the water or more than a toe in the water of the vaping market I think we must view with considerable suspicion. . .” (http://www.bbc.co.uk/programmes/b070dq8h";http://www.bbc.co.uk/programme... )</li;</ol;
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<LI value="5";If your group was to replicate the study, http://drugscience.org.uk/blog/2015/08/27/blinded-smoke-why-do-e-cigaret... Professor Nutt and yourself have recently stated would be an appropriate piece of work subsequent to the publication of new data, would you feel comfortable utilising&nbsp; the same funder?</li;</ol;
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<LI value="6";You have stated with David Nutt ( as per e) above) that : “A repetition would be particularly timely now the evidence base for ENDS has grown” which appears entirely reasonable, responsible and “scientific”. However, in the Lancet letter, you both, with the other authors, confidently claim that “Our model’s results for harms to users of e-cigarettes provided Public Health England with the basis for their correct calculation to estimate that e-cigarettes are 95% less harmful to users than smoking.” There is clear incongruity in these two statements you make, unless in the time span between them, you have undertaken a full, “timely” review, which if you have, to my knowledge, there has been no peer reviewed publication of. Please can you elucidate the answer to this contradiction in assertions? What are your thoughts on Combes and Balls assertion, further, that the PHE Report was <EM;not peer reviewed</em;?</li;</ol;
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<LI value="6";Finally, I note from the Declaration of Competing interests in your letter, that Professor Polosa has not declared the paid work he apparently undertook for Philip Morris, as documented here: https://industrydocuments.library.ucsf.edu/tobacco/docs/#id=zmmk0150";ht... and apparently confirmed in signature here http://www.tobaccotactics.org/index.php/Riccardo_Polosa";http://www.toba... . He has stated that previous critiques of your original paper raised “irrelevant” conflict of interest issues. I find it interesting that, again here, he has chosen not to disclose the apparent previous work undertaken for the “Tobacco Giant”, Philip Morris, and again I am wondering, as the contact for this latest letter, if you can elucidate the foundation for this apparent omission?</li;</ol;
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Your colleague, Professor Nutt, has previously stated publically that electronic cigarettes “are the most significant advance since antibiotics” (https://www.youtube.com/watch?v=8rYSFiyZhwQ";https://www.youtube.com/wat... ). This is, I believe, a gross exaggeration of efficacy, based on a paucity of high quality data to support it, and posted on 08.12.13. just <EM;prior</em; to when your paper was received for Review on 23.12.13. It is further interesting to note that Robert West has reservedly recently commented regarding the efficacy of E-Cigarettes: “. . . the numbers of users of electronic cigarettes successfully quitting is not as many as some e-cigarette enthusiasts claim” (http://home.bt.com/news/uk-news/891000-used-e-cigarettes-to-try-and-quit... ).
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I do wonder if, further down the line, when enough high quality data is accumulated regarding the safety of e-cigarettes, that the “95% safer” paper will, too, be identified as highly misleading?
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I look forward to hearing your opinions in response.
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Yours sincerely,
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David Bareham
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<STRONG;David W Bareham BSc Hons (Physiotherapy) MSc (Pain Management).</strong;
<STRONG;Specialist Respiratory Physiotherapist</strong;
<STRONG;Lincolnshire Community Health Services NHS Trust</strong;
<STRONG;Locality Office</strong;
<STRONG;Louth County Hospital</strong;
<STRONG;Louth</strong;
<STRONG;LN11 0EU</strong;
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<STRONG;Tel:&nbsp; 01205 315247 Option 5</strong;
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<STRONG;Fax: 01507 354957&nbsp; </strong;
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