Wednesday, January 29, 2014

Exploiting the 50th Anniversary of the Surgeon General’s Report on Smoking

Fifty years ago, U.S. Surgeon General Luther Terry issued a landmark report describing the health risks of cigarette smoking.  Tobacco prohibitionists are using the anniversary to promote onerous measures aimed at the tobacco industry and consumers (here).

American Heart Association president Dr. Mariell Jessup claims that “taxes, strong smoke-free laws and fully funding state tobacco prevention programs… can reduce the number of adult smokers to less than 10 percent of the population in 10 years.”

Similarly unfounded assertions have been made for decades. In 1984, Surgeon General C. Everett Koop declared that the U.S. could be smoke-free by the year 2000 (here).

NBC reported that “raising the legal age to buy tobacco products to 21 would go a long way to stopping kids from ever getting addicted in the first place,” and it cites the American Heart Association, American Lung Association, American Cancer Society and the Campaign for Tobacco-Free Kids for support.  Unable to obtain an outright tobacco ban, these groups hope to impose rules similar to those for alcohol.  

Dr. Michael Fiore of the University of Wisconsin’s Center for Tobacco Research and Intervention, says tougher tobacco age restrictions make sense: “We do it with booze yet we don’t do it with cigarettes, when cigarettes kill about 10 times more people than alcohol does.”  That argument disguises the fact that alcohol has proven far more deadly for teenagers.

The current age requirement for cigarette purchase is 18 years, and the smoking prevalence for high school seniors is 16%.  In contrast, the requirement for alcohol purchase is 21 years; 39% of high school seniors currently drink and 26% have been drunk recently (here).

Dr. Fiore bemoans the lack of physician engagement with smokers; he thinks they should be nagged: “I would never dream of letting a patient with high blood pressure leave my office without treating it.  But every day in America, millions of Americans go in and out of a physician’s office and their smoking is not treated.”

The past 50 years have witnessed an increasingly aggressive tobacco control movement, with declining returns.  Tobacco control may have contributed, as the media suggests, to the saving of eight million smokers lives (abstract here), but tobacco prohibitionists also share responsibility for the 17.7 million smokers who died prematurely because they were denied factual information about safer smoke-free tobacco products.  

Instead of exploiting the 50th anniversary, all public health groups should endorse rational, science-based tobacco harm reduction.  America’s 45 million smokers deserve nothing less.

Thursday, January 23, 2014

BMJ Editorial: Holding the Line For Ignorance

The British Medical Journal grossly erred in its January 2 commentary, “Hold the Line Against Tobacco” (here), by editor Dr. Fiona Godlee.
BMJ asserts that e-cigarettes pose a “grave risk to public health because of their potential to renormalise and glamourise smoking.”  As Clive Bates pointed out in a scathing critical comment (here), “It requires heroic contortions of logic to regard the emergence of a product that is perhaps 99-100% less risky than cigarettes and a viable alternative to smoking as an adverse development… [The e-cigarette] should really be seen as a disruptive intrusion into the cigarette industry: a new high technology product entering the market for the popular legal recreational drug, nicotine, and posing a threat to the dominant and most harmful delivery system, the cigarette… Your editorial follows the established pattern of prohibitionist public health activists of focusing on minor or implausible risks for which no evidence exists in reality, while ignoring or diminishing the huge potential benefits that are real and visible from adopting e-cigarettes.”

Dr. Godlee’s commentary veers dramatically from the norms of science journal precision, as seen in this extraordinary claim: Moves by New York City Mayor Bloomberg’s administration “against tobacco, trans fats, and sugary drinks, and for promoting physical activity and calorie counts on menus, are credited with improving life expectancy among New Yorkers—now two years higher than the US national average.”

Nothing in the city’s formal report on life expectancy (here) even remotely supports this claim.  The report mentions anti-smoking policies, but offers no proof that they account for differences in mortality from heart diseases and cancer between New York and the U.S. as a whole.  Mr. Bates is right to call for “a BMJ special edition setting out the evidence for the effectiveness of these measures in improving life expectancy in New York.” 

The dominant theme of the BMJ editorial is revulsion of the tobacco industry: “E-cigarettes also legitimise the industry, buying tobacco companies a seat as ‘partners’ at the health policy table,” a position Dr. Godlee rejects.

The reality is that in the U.S., regulation of the tobacco industry has de facto legitimized it and guaranteed companies a seat at the health policy table.  Indeed, FDA officials are compelled to consider industry research and analysis, and if the FDA fails to do so it is subject to repercussions. 

Appropos of this, it is sadly worth noting that the FDA has also lapsed in its adherence to rigorous scientific principles.  Its recently released preliminary report on menthol (here), which I have commented on (here), is a case in point.  Lorillard last November submitted these scathing comments to the FDA public docket (here):

“Unfortunately, FDA’s review of the available scientific information on menthol cigarettes falls far short of FDA’s own established standards of scientific integrity and cannot be used to draw valid conclusions, nor can it serve as the basis for regulatory action.  FDA’s analysis suffers from many significant flaws and its conclusions are at times based upon unsupported speculation and conjecture. Many of the studies relied upon by FDA fail to meet the appropriate standard of scientific evidence, yet numerous high-quality studies are improperly and inexplicably discounted or entirely omitted.”  The 134-page submission backs the company’s claims with robust evidence. 

Rigorous standards imposed by regulation should apply equally to all parties, including regulators themselves.  Such standards may be especially uncomfortable for tobacco prohibitionists, who are prone to gross abuse of the facts.

Thursday, January 16, 2014

Ban the Snus Ban

The European Union last year confirmed its irrational ban on smokeless tobacco, denying smokers safer products that are widely used in Sweden.  In October, shortly before the European Parliament extended the ban by supporting the revised EU Tobacco Directive, Europe’s leading tobacco research and policy experts expressed their support for tobacco harm reduction in a letter to the United Kingdom’s Parliamentary members and to UK Secretary of State for Health Jeremy Hunt (originally published here).  Their argument, brilliantly stated, should resonate with U.S. policymakers and public health practitioners.

To:         Rt Hon Jeremy Hunt MP
  Secretary of State for Health
              Richmond House
              London SW1A 2NS
CC:       UK Members of the European Parliament
From:    Specialists in tobacco and public health

Date:     7 October 2013

Dear Mr Hunt,
Re: Tobacco Products Directive and snus
We are writing to you as independent public health specialists to react to your letter to UK MEPs on the Tobacco Products Directive. We were disappointed that you declared support for banning snus outside Sweden, and believe the justification given is inadequate.  The position statement[1] argues that we would take a ‘backward step for public health by relaxing a ban on an existing category of tobacco’.  This reasoning is weak unless you plan an imminent ban on cigarettes.  In reality, it simply assists the most harmful form of tobacco, cigarettes, by banning a much safer alternative and causes ill-health by denying this option to smokers.  We disagree with the policy of banning snus and regard it as unscientific, unethical and far more likely than not to contribute to additional death and disease from smoking. This letter briefly explains why there is no justification for the ban, and why many leading experts have called for it to be lifted, for example in a letter from 15 experts to Commissioner Dalli in 2011[2].  Sadly, these well-informed and carefully argued views from public health experts were ignored when the Commission published its proposal for the revised directive in December 2012. In the case of snus, the Department of Health has not followed the logic of its own approach to ‘harm reduction’. The consequence is an unjustified and harmful ban based on a policy-making error made 25 years ago.  We hope this letter is sufficient reason for you to reconsider the issue of the snus ban with an open mind and fresh pair of eyes.

An unjustified ban on snus – misunderstood gateway effects.  Snus has been banned in the EU, other than in Sweden, since 1992.  The original reason for the ban was a fear that it could become a ‘gateway’ to smoking for young people. This risk was only ever hypothetical but the subsequent reality of snus use in both Norway and Sweden shows that it is, beyond doubt, a gateway out of smoking.  Snus is used as an alternative to smoking and as a means to quit. Further, snus is not increasing but rather decreasing onset of smoking in young people.   It is primarily because of snus use that Sweden and Norway have the lowest rates of smoking in Europe, by far.  It is sometimes claimed that snus should be banned because is not 100% safe. However, this misunderstands its impact: the overall effect of snus has been protective and highly beneficial to public health where it is on sale freely.  The original justification for the ban has been overturned by evidence from the real world, and there is now no justification to treat snus differently to any other smokeless tobacco. As with e-cigarettes, there are good reasons to carefully encourage its use as an alternative to smoking for people who cannot or do not wish to quit using nicotine or tobacco. 
Health potential of snus in the rest of Europe.  There has been a remarkable success for public health in Sweden and Norway that deserves more recognition.  According to the most recent Eurobarometer survey[3], adult smoking prevalence in Sweden is just 13%, far lower than the EU average of 28%. Nothing we consume can be 100% safe or pure, but the risks associated with snus use are of the order of 95-99% lower than for smoking[4]. This has resulted in substantially reduced burdens of tobacco-related disease (cancer, cardiovascular disease, emphysema). For example, the rate of lung cancer mortality in Sweden is half that of its neighbour Denmark[5]. Sweden also has significantly lower levels of oral cancer mortality. It is not enough to argue, as the Commission does, that snus is ‘toxic and addictive’: it is a very much less toxic and also less addictive than cigarettes but its effective nicotine delivery still makes it a viable alternative to smoking. This is the well-established idea of ‘tobacco harm reduction’ working for health here in Europe. More data are appended at the end of this letter.
An unethical ban.  When people use snus instead of smoking they are significantly reducing their own health risks, at their own expense, on their own initiative, and with no harm to anyone else.  On what basis can a government justify using the force of European law to prevent them doing this? The consequence, visible everywhere in the European Union outside Sweden, is more smoking and more death and disease than there would otherwise be. Even if a single user somewhere in Britain wished to use it, why should a European Union directive prevent them? Why should the UK wish to prevent someone using it in another country, such as Denmark? We can find no precedent for governments banning much safer alternatives to risky products. This highly irregular policy raises major ethical concerns and implicates the European Union and UK government in causing additional unnecessary harm.

Incoherent tobacco legislation brings the EU into disrepute. The approach to snus policy and legislation rests on a 25-year-old error that officials have refused to accept or correct[6]. There is no credible explanation for why the safest known form of tobacco in the world, snus, is banned when the most dangerous, the manufactured cigarette, is widely available.  No one can explain why smokeless tobacco placed in the mouth and chewed is permitted, but if sucked it is banned. How can a ban be consistent with the principle of free movement of goods, especially when we know the impact of the product is overall beneficial to health where it is not banned? These obvious contradictions disfigure such important legislation. All branches of the legislature have professional and legal obligations to take advances in scientific understanding into account, and this is especially important given the lives at stake.  It is now time face these responsibilities, and to correct the 25 year error behind the ban on snus.
Fixing the snus provisions in the tobacco products directive. There are three main options, which we list in order of preference, with the most strongly justified first.
1.      Treat snus like any other smokeless tobacco. The definitions in the directive can be amended to remove the arbitrary discrimination between snus and other smokeless tobaccos. This would be the simplest and best approach.
2.      Treat snus like a novel tobacco product. Snus products could go through the same process for introduction of novel tobacco products, such as those that heat tobacco, under Article 17 of the proposed directive. Given snus has not been present for at least 20 years outside Sweden, it is reasonable to treat it as ‘novel’.
3.      Allow an exception to the general ban where snus has traditional use. This would allow members states to determine that snus meets a traditional product demand, and to permit it.  
We also advocate a regulatory framework for all smokeless tobacco that would place limits on the toxic contaminants that potentially cause harm. The WHO’s expert group on smokeless tobacco recommended exactly this[7], and the approach is supported by the UK Royal College of Physicians and many other experts. 
There is no scientific, ethical or legal basis to ban snus, and we hope you will reconsider and change your position to support one of the three options listed above. In reality, you would be supporting better health and challenging the dominance of cigarette smoking, which is the most harmful and addictive form of tobacco and nicotine use.

Yours sincerely

Professor Martin Jarvis
Emeritus Professor of Health Psychology
Department of Epidemiology & Public Health
University College London, UK
Professor Peter Hajek
UK Centre for Tobacco and Alcohol Studies
Wolfson Institute of Preventive Medicine
Barts and The London School of Medicine and Dentistry Queen Mary, University of London

Professor Gerry Stimson
Emeritus Professor, Imperial College London; Visiting Professor, London School of Hygiene and Tropical Medicine
Professor John Britton
Professor of Epidemiology, 
Faculty of Medicine & Health Sciences, University of Nottingham

Prof. Riccardo Polosa, MD, PhD
Full Professor of Internal Medicine
Università degli Studi di Catania, Italy

Jacques Le Houezec, PhD
Consultant in Public Health, Tobacco dependence, France
Professor Dr Michael Kunze
Head of the Institute for Social Medicine
Medical University of Vienna
Karl Erik Lund PhD
Norwegian Institute for Alcohol and Drug Research, Oslo Norway
Professor Karl Olov Fagerström PhD
Emeritus Professor of Psychology
President Fagerström Consulting AB
Professor Tony Axéll
Emeritus Professor Geriatric Dentistry
Consultant in Oral Medicine
Dr Lars Ramström
Director Institute for Tobacco Studies
Stockholm Sweden
Clive Bates
Former Director,
Action on Smoking & Health (UK) 1997-2003

Dr Lars Ramström
Director Institute for Tobacco Studies
Stockholm Sweden
Clive Bates
Former Director,
Action on Smoking & Health (UK) 1997-2003


[1]      Secretary of State for Health, Letter to UK MEPs. Proposal for a revised tobacco products directive. September 2013 (undated) [link]
[2]      Axell T, Borland R, Britton J, Fagerström K, Foulds J, Gartner C, Hughes J, Jarvis M, Kozlowski L, Kunze M, Le Houezec J, Lund K, McNeill A, Ramström L, Sweanor D. (2011) Letter to Commissioner Dalli: Advancement of the scientific basis for the EU Tobacco Products Directive, May 2011  [link]
[3]      European Commission, Special Eurobarometer 385, Attitudes of European Citizens to Tobacco, March 2012
[4]      Phillips CV, Rabiu D, Rodu B. Calculating the comparative mortality risk from smokeless tobacco versus smoking. Am J Epidemiol 2006; 163: S189.
[5]      WHO / International Agency for Research on Cancer:  Cancer mortality database. Lung cancer is a good marker for all smoking related diseases as it is mostly (c. 85-90%) attributable to smoking.  
[6]      C Bates, L Ramström, A critique of the scientific reasoning supporting the proposed measures relating to oral tobacco, March 2013 [link]
[7]      WHO study group on tobacco product regulation (2009). Report on The Scientific Basis Of Tobacco Product Regulation: third report of a WHO study group. WHO technical report series; no. 955. WHO, Geneva. [Link]