The truth on Dalligate, as told to Politio.eu

G’morning,

You seem to have gotten the Dalli affair a bit backwards (as has everyone else too, so don’t feel bad about it).

He had this enclosed letter from the non affiliated Tobacco Harm Reduction pros around the world a full year before the scandal broke.

Dalli it seems (or whoever it actually was), was trying to make a nice buck by doing the right thing (that should have been done anyway based on the science) at the same time.

The tobacco industry (Swedish Match, a history first?) did the right thing and blew the whistle on this, and got punished pretty brutally for it with a continued “snus” ban.

Resulting loss of life in the EU using Norwegian “snus” adoption rates = 140,000 fatalities per year.

Cheerio

Atakan Befrits

(Quite potentially Dalli (or whoever it was) was planning this “Regulatory Racketeering” all along. I can prove that “government replies” in the Public Consultation on the TPD2 in 2010 that gave 89,000 responses compared to the normal 500 was doctored. 462 Government replies came from all over Europe. 62.5% were in favor of lifting the “snus” ban and another 17.5% were neutral to lifting or keeping the ban. Only 20% were in favor of keeping the ban. 

That is a whopping 80% in favor of, or neutral to, lifting the ban on “snus” in the EU. Answers also specifically supplied by actual Government people working with public health, and not those working with the politics surrounding public health.

These answers were all disqualified by Dalli and DG-SANCO and instead each country was officially asked for 1 (one) country view on “snus” with the predictable result that all were negative to lifting the ban.

DG-SANCO also leaked false information to Swedish Anti-Nicotine lobbyists a full 6 months prior to any information becoming public. Anti-Nicotine lobby in Sweden used this information to silence Swedish media by implying that the entire EU was so strongly against lifting the ban on “snus” that Swedish media would only look like complete idiots if they pursued the matter any further. I have proof of the leaks and of course letters from DG-SANCO denying any leakage)

Please find the letter below in full text:

2011-05-31

To:

Mr. John Dalli,

European Commissioner for Health and Consumer Protection

European Commission

B-1049Brussels,Belgium

Copy to:

Michel Barnier, European Commissioner for Internal Market and Services,

José Manuel Barroso, President of the European Commission

Máire Geoghegan-Quinn, European Commissioner for Research and Innovation

Marianne Klingbeil, Deputy Secretary General, Secretariat General, European Commission

Cecilia Malmström, European Commissioner for Home Affairs

Antonio Tajani, Vice- President of the European Commission

 

The advancement of the scientific basis for the EU Tobacco Products Directive

Sir,

As a group of scientists whose research is targeted towards minimizing tobacco-induced diseases we very much welcome your statements that a tougher stance is needed on smoking as a major health threat. We are convinced that the current revision of the EU Tobacco Products Directive can strengthen the effectiveness of the directive to ensure a high level of health protection. But, we are also aware that an optimal result cannot be achieved unless particular attention is given to the advancement of the scientific basis.

We have noticed that the ongoing general discussion around the revision contains various examples of suggestions that are not completely in line with latest scientific evidence. Therefore we would like to highlight both some corner-stones of tobacco science and some recent advances that would constitute essential parts of an appropriate scientific basis for the revision.

From a scientific perspective the provisions of the Tobacco Products Directive should take into account that different tobacco and other nicotine delivery products vary substantially in their health risk and addictiveness. Nicotine is an addictive substance but plays a minor role in causation of tobacco-induced diseases which are mainly caused by the combustion products that accompany the nicotine in tobacco smoke. Consequently, combusted tobacco products represent the most risky nicotine products and non-combusted products are lower in risk. Among the non-combusted nicotine products there is also a wide spectrum of health risk, ranging from highly toxic South-East Asian and Sudanese tobacco products to American snuff, Swedish Snus and non-tobacco nicotine products.

The most logical kind of tobacco product regulation for health protection would be to ban all combusted products and subject combustion-free tobacco/nicotine products to strict regulation according to risk level. An immediate ban of cigarettes and other combusted tobacco products is not feasible, but the possibility of successively phasing out these products over the long term deserves consideration. In the short term, establishing a regulatory framework for all tobacco products is much more feasible and could assist the eventual phasing out of combustible tobacco (Royal College of Physicians, 2008; Le Houezec et al., 2011). Proposals for the design of such regulation are readily available in the third report of the WHO study group on tobacco product regulation (WHO, 2009).

The WHO Framework Convention on Tobacco Control, FCTC, points out (in Article 1) that tobacco control means a range of supply, demand and harm reduction strategies. The “harm reduction strategies” deserve particular attention here, since there is evidence suggesting that such strategies can yield substantial health benefits in tobacco control, if smokers are encouraged to use less harmful nicotine products in appropriate ways (Royal College of Physicians, 2007; European Monitoring Centre for Drugs and Drug Addiction, 2010). The products with the greatest potential for use in tobacco harm reduction are non-tobacco nicotine products and low-toxicity combustion-free tobacco, such as Swedish Snus. It has been estimated that for total mortality, the median relative risks for individual users of such products were 9% and 5% of the risk associated with smoking for those aged 35 to 49 and ≥50 years, respectively (Levy et al., 2004). Another study has elucidated comparative health risks by calculating the shortening of life expectancy due to different patterns of tobacco use. Those who after quitting smoking use snus are estimated to have almost equally small shortening of life expectancy as those who quit all nicotine use (Gartner et al., 2007). There are no corresponding data for non-tobacco nicotine products, but it could be assumed that their effects are similar.

It should further be noticed that switching to a combustion-free tobacco/nicotine product may also be a stepping-stone to subsequent nicotine-free status so as illustrated by analyses of snus use in Sweden(Ramström & Wikmans, 2011).

All disease-specific health risks are much smaller for low-toxicity combustion-free tobacco/nicotine products than for cigarettes. “Complete substitution of STP for tobacco smoking would thus ultimately prevent nearly all deaths from respiratory disease currently caused by smoking, which in total represent nearly half of all deaths caused by smoking.” (SCENIHR 2008; p. 113). “It is therefore reasonable to draw a conservative conclusion that substitution of smoking by snus use would, in due course, reduce the cardiovascular mortality that currently arises from tobacco use by at least 50%.” (SCENIHR 2008, p. 114). As far as oral cancer is concerned combustion-free tobacco/nicotine products from South-East Asia andSudan, incur serious risk, while no such association has been found for Swedish snus (Luo et al., 2007). Some earlier studies suggested a possible association between snus and pancreatic cancer (although weaker than the association with smoking). However, the most recently published study, co-authored by one of the authors of the old study, is now rejecting the older conclusions (Bertuccio et al., 2011).

Evidence from Sweden has been summarized by saying: “In Sweden, the availability and use by men of an oral tobacco product called snus, one of the less hazardous smokeless tobacco products, is widely recognised to have contributed to the low prevalence of smoking in Swedish men and consequent low rates of lung cancer.” (Royal College of Physicians, 2008; p. 4), or, “Thus in Sweden, where there has apparently been substantial transfer from smoking to snus, the availability of snus may have been beneficial to public health.” (SCENIHR, 2008; p. 117). A recently published study has further illustrated how the use of snus inSweden has contributed to the decline of smoking in the 1990s (Stenbeck et al., 2009).

Low-toxicity combustion-free tobacco/nicotine products may be beneficial for public health by serving as smoking cessation aids that are easily available for large scale unassisted smoking cessation in the real world outside clinical settings. This is the context in which smoking cessation plays its major role as a public health tool (Chapman & MacKenzie , 2010). Some Swedish studies suggest that Snus may be the most effective aid for self-help quitters and among men the most commonly used one (Ramström & Foulds, 2006; Ramström & Wikmans, 2011). Recent studies inNorwayequally found that quit attempts with snus have yielded a higher success rate than other methods thereby demonstrating that the validity of the Swedish findings is not limited toSwedenwith its specific traditions (Lund et al., 2010; Lund et al., 2011). The combination of high usage and high efficacy that has consistently been found in the Scandinavian studies suggest a high level of efficiency of low-toxicity combustion-free tobacco products as smoking cessation aids in unassisted smoking cessation in the real world. Further, a recent short term randomized study found that Camel snus produces abstinence rates at least equivalent to 4 mg nicotine gum (Kotlyar et al., 2011).

In the discussions regarding public health aspects there have been concerns that there could be a risk of unintended negative side-effects. For example, products like snus might be a gateway to subsequent initiation of smoking in non-smoking adolescents. However, several studies have found that this has not occurred inSweden(Furberg et al., 2005; Ramström & Foulds, 2006; Galanti et al., 2008). Most but not all corresponding studies in the US show results consistent with the Swedish findings in that they do not show that youth smokeless use causes an increased subsequent use of smoked tobacco (O’Connor et al., 2005; Timberlake et al., 2009). There are also concerns that dual use of cigarettes and combustion-free tobacco might weaken the motivation to quit smoking or that switching from cigarettes to snus might strengthen nicotine dependence. However, recently published studies have not found support for these concerns (Frost-Pineda et al., 2010; Ramström & Wikmans, 2011). The risk of all these potential negative consequences could also be minimised through appropriate regulation of all tobacco products.

We have a vision of a tobacco-free society, but along the road towards that goal we must help minimise the health burden of remaining tobacco use through appropriate regulation of all tobacco/nicotine products based on their level of health risk. We hope that the revised EU Tobacco Products Directive will be an effective part of such efforts.

Yours sincerely,

Tony Axell, Senior Consultant, Dept. of Maxillofacial Surgery, Halland Hospital Halmstad, Halmstad, Sweden.

Ron Borland, Professor, The Cancer Council Victoria, Australia.

John Britton, Professor of Epidemiology, University of Nottingham. UK.

Karl Fagerström, Principal Investigator, Fagerström Consulting, Helsingborg, Sweden.

Jonathan Foulds , Professor of Public Health Sciences & Psychiatry, Penn State University, College of Medicine Cancer Institute, Cancer Control Program. Hershey, PA, USA.

Coral Gartner, Professor, The University of Queensland Centre for Clinical Research, Brisbane, Australia.

John Hughes, Professor, Dept of Psychiatry, University of Vermont, Burlington, VT, USA.

Martin Jarvis, Emeritus Professor of Health Psychology, University College, London. UK.

Lynn Kozlowski, Professor, School of Public Health and Health Professions, State University of New York.  NY, USA.

Michael Kunze, Univ.Prof., Institute of Social Medicine, ECDC (European Centre for Disease Prevention and Control), Centre of Public Health, Medical University Vienna, Austria.

Jacques Le Houezec, Consultant in Public Health, Tobacco dependence, Rennes, France

Karl E Lund, Research Director, Norwegian Institute for Alcohol and Drug Research, Oslo, Norway.

Ann McNeill, Professor of Health Policy & Promotion, University ofNottingham.UK.

Lars Ramström, Principal Investigator, Institute for Tobacco Studies,Stockholm,Sweden.

David SweanorAdjunct Professor, Faculty of Law, University of Ottawa, Canada.

References

Bertuccio P, La Vecchia C, Silverman DT, Petersen GM, Bracci PM, Negri E, Li D, Risch HA, Olson SH, Gallinger S, Miller AB, Bueno-de-Mesquita HB, Talamini R, Polesel J, Ghadirian P, Baghurst PA, Zatonski W, Fontham ET, Bamlet WR, Holly EA, Lucenteforte E, Hassan M, Yu H, Kurtz RC, Cotterchio M, Su J, Maisonneuve P, Duell EJ, Bosetti C, Boffetta P. Cigar and pipe smoking, smokeless tobacco use and pancreatic cancer: an analysis from the International Pancreatic Cancer Case-Control Consortium (PanC4). Ann Oncol. 2011 Jan 18. [Epub ahead of print].

Chapman S, MacKenzie R. The global research neglect of unassisted smoking cessation: causes and consequences. PLoS Med. 2010 Feb 9:7(2):e1000216.

European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). Harm reduction: evidence, impacts and challenges. EMCDDA scientific monograph No. 10. Lisbon: April 2010. Available from

Frost-Pineda K, Appleton S, Fisher M, Fox K, Gaworski CL. Does dual use jeopardize the potential role of smokeless tobacco in harm reduction? Nicotine Tob Res. 2010 Nov;12(11):1055-67.

Furberg, H., Bulik, C. M., Lerman, C., et al. (2005), ‘Is Swedish snus associated with smoking initiation or smoking cessation?’ Tob Control 14, pp. 422–4. [here]

Galanti M. R., Rosendahl I,. Wickholm S. The development of tobacco use in adolescence among ‘‘snus starters’’ and ‘‘cigarette starters’’: An analysis of the Swedish ‘‘BROMS’’ cohort. Nicotine Tob Res 2008; 10: 315 – 23.

Gartner C. E., HallW. H., Vos T. H., Bertram M.Y.,Wallace A. L., Lim S. S. Assessment of Swedish snus for tobacco harm reduction: an epidemiological modelling study. The Lancet 2007; 369: 2010–4.

Kotlyar M, Hertsgaard LA, Lindgren BR, Jensen JA, Carmella SG, Stepanov I, Murphy SE, Hecht SS, Hatsukami DK. Effect of oral snus and medicinal nicotine in smokers on toxicant exposure and withdrawal symptoms: a feasibility study. Cancer Epidemiol Biomarkers Prev. 2011 Jan;20(1):91-100.

Le Houezec J, McNeill A, Britton J. Tobacco, nicotine and harm reduction. Drug Alcohol Rev. 2011 Mar;30(2):119-23.

Levy, D. T., Mumford, E. A., Cummings, K. M., et al. (2004), ‘The relative risks of a low-nitrosamine smokeless tobacco product compared with smoking cigarettes: estimates of a panel of experts’, Cancer Epidemiology, Biomarkers and Prevention 13, pp. 2035–42.

LundK. E., McNeill A., Scheffels J. The use of snus for quitting smoking compared with medicinal products. Nicotine Tob Res 2010; 12: 817–22.

LundK., Scheffels J., McNeill A. The association between use of snus and quit rates for smoking: results from seven Norwegian cross-sectional studies. Addiction 2011; 106: 162–7.

Luo J, Ye W, Zendehdel K, Adami J, Adami HO, Boffetta P, Nyrén O. Oral use of Swedish moist snuff (snus) and risk for cancer of the mouth, lung, and pancreas in male construction workers: a retrospective cohort study. Lancet. 2007 Jun 16;369(9578):2015-20.

O’Connor RJ, Kozlowski LT, Flaherty BP, Edwards BQ. Most smokeless tobacco use does not cause cigarette smoking: results from the 2000 National Household Survey on Drug Abuse. Addict Behav. 2005 Feb;30(2):325-36.

Ramstrom L., Foulds J. Role of snus in initiation and cessation of tobacco smoking in Sweden. Tob Control 2006; 15:210–4.

Ramström L., Wikmans T. Revisiting Harm Reduction – An Update of Pros and Cons. Poster presented at the ECToH conference Tobacco or Health in Amsterdam 28-30 Mars 2011. Available from http://www.forskningsgruppen.com/vakt.htm

Royal College of Physicians. Harm Reduction in Nicotine Addiction. Helping People Who Can’t Quit. A report by the Tobacco Advisory Group of the Royal College of Physicians, October 2007. London: RCP.

Royal College of Physicians. Ending tobacco smoking in Britain Radical strategies for prevention and harm reduction in nicotine addiction. A report by the Tobacco Advisory Group of the Royal College of Physicians, September 2008.

SCENIHR. Health effects of smokeless tobacco products, Scientific Committee on Emerging and Newly Identified Health Risks, European Commission,Brussels. Available at

Stenbeck M, Hagquist C, Rosén M. The association of snus and smoking behaviour: a cohort analysis of Swedish males in the 1990s. Addiction. 2009 Sep;104(9):1579-85.

Timberlake, D. S., Huh, J. and Lakon, C. M. (2009), ‘Use of propensity score matching in evaluating smokeless tobacco as a gateway to smoking’. Nicotine Tob Res. 11, pp. 455–62.

WHO study group on tobacco product regulation. Report on The Scientific Basis Of Tobacco Product Regulation: third report of a WHO study group. WHO technical report series; no. 955. WHO, Geneva; 2009.

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