September 15, 2015

Stanton A. Glantz, PhD

UK report claiming e-cigs 95% safer than cigs based on one industry-linked report questions PHE's scientific credibilty

On August 19, 2015, the UK Government issued a press release with the headline “E-cigarettes around 95% less harmful than tobacco estimates landmark review”  publicizing a new report commissioned by Public Health England by and led by Professor Ann McNeill (King’s College London) and Professor Peter Hajek (Queen Mary University of London), extolling e-cigarettes as a harm reduction strategy and minimizing the associated risks.  It was the claim of virtual safety, however, that attracted tremendous media interest.
The report immediately spread around the world, including being widely distributed to members of the California Legislature by tobacco industry lobbyists opposing proposed legislation that would have included e-cigarettes in the state’s clean indoor air cigarette sales licensing laws. 
Many people emailed me for comment, something I could not do because I was off backpacking in the Sierra Nevada Mountains with my wife.
Now that I am back and digging out I finally had time to read the report.  There are many problems with the report, but the most appalling one is the conclusion, hyped in the government press release, that e-cigarettes are 95% safer than cigarettes.  Rather than being based on a broad body of evidence this claim relies on a single study, Estimating the Harms of Nicotine-Containing Products Using the MCDA Approach.   This paper does not contain a shred of actual evidence, but rather represents the opinions of its twelve authors (DJ Nutt, LD Phillips, D Balfour, HV Curran, M Dockrell, J Foulds, K Fagerstrom, K Letlape, A Milton, R Polosa, J Ramsey, and D Sweanor), who are harm-reduction and e-cigarette enthusiasts. 
More important, as reported initially in The Lancet in its August 29 editorial on the report titled, “E-cigarettes: Public Health England’s evidence-based confusion,” there are serious financial conflicts of interest associated with this paper:

It is worth reading the paper on which PHE has based its latest advice carefully. Nutt and colleagues describe how the Independent Scientific Committee on Drugs, which Nutt founded in 2010, convened an international expert panel to consider the “relative importance of different types of harm related to the use of nicotine-containing products”. During a two-day workshop in July, 2013, the panel met in London to review the context of perceived harms from nicotine products, the range of products (including “electronic nicotine delivery system products”), and the criteria of harms. The group scored the products for harm, and weightings were applied to the results.  Based on the opinions of this group, cigarettes were ranked as the most harmful nicotine product with a score of 99·6. E-cigarettes were estimated to have only 4% of the maximum relative harm. It is this result that yields the “95% less harmful” figure reported last week.
But neither PHE nor McNeill and Hajek report the caveats that Nutt and colleagues themselves emphasised in their paper. First, there was a “lack of hard evidence for the harms of most products on most of the criteria”. Second, “there was no formal criterion for the recruitment of the experts”. In other words, the opinions of a small group of individuals with no prespecified expertise in tobacco control were based on an almost total absence of evidence of harm. It is on this extraordinarily fl imsy foundation that PHE based the major conclusion and message of its report.
The study led by Nutt was funded by Euroswiss Health and Lega Italiana Anti Fumo (LIAF). Riccardo Polosa, one of the authors of the Nutt paper, is the Chief Scientifi c Advisor to LIAF. In the paper, he reports serving as a consultant to Arbi Group Srl, an e-cigarette distributor. His research on e-cigarettes is currently supported by LIAF. Another author reports serving as a consultant to manufacturers of smoking cessation products. The editors of the journal added a note at the end of the paper warning readers about the “potential confl ict of interest” associated with this work.

The Lancet  editorial was picked up by the London Daily Mail in an article, “E-cigarette industry funded experts who ruled vaping is safe: Official advice is based on research scientists in the pay of manufacturers,” whose title says it all.
Martin McKee and Simon Capewell, writing in the British Medical Journal on September 15, also raised serious questions about the Nutt paper and provided more evidence of conflicts of interest in their article, “Evidence about electronic cigarettes: a foundation built on rock or sand?”:

We might also expect that the prominently featured “95% less harmful” figure was based on a detailed review of evidence, supplemented by modelling. In fact, it comes from a single meeting of 12 people convened to develop a multicriteria decision analysis (MCDA) model to synthesise their opinions on the harms associated with different nicotine containing products; the results of the meeting were summarised in a research paper. The authors state: “The sponsor of the study had no role in any stage of the MCDA process or in the writing of this article, and was not present at the workshop.” However, given the importance of complete transparency in an area as controversial as this, it is legitimate to ask about the sponsors. One is a company called EuroSwiss Health.  An internet search reveals little about its activities other than that it funded the meeting, but it is one of several companies registered at the same address in a village outside Geneva with the same chief executive. He is reported to have previously received funding from British American Tobacco (BAT) for writing a book on nicotine as a means of harm reduction, although the book states that “the statements, findings, conclusions and recommendations contained in the book were developed independently of BAT.” He also endorsed BAT’s public health credentials in its 2013 sustainability report.
The paper also acknowledges support from Lega Italiana Anti Fumo (Italian Anti-Smoking League), whose chief scientific adviser was one of the 12 people attending the meeting. He declares funding from an e-cigarette manufacturer but not the funding he is reported elsewhere to have received previously from tobacco company Philip Morris International. The rationale for selecting the members of the panel is not provided, but they include several known e-cigarette champions, some of whom also declare industry funding in the paper. Some others present at the meeting are not known for their expertise in tobacco control. The meeting was also attended by the tobacco lead at PHE. Furthermore, their paper tellingly concedes that “A limitation of this study is the lack of hard evidence for the harms of most products on most of the criteria.” However, none of these links or limitations are discussed in the PHE report. [citations omitted]

Subsequently, on November 3, 2015, BMJ  published an investigative story, "Public Health England’s troubled trail," that raised much broader issues about conflicts of interest and pro-industry bias at Public Health England.  It also included a detailed discussion of conflicts of interest on the PHE e-cigarette report, including an amazing infographic, "Vaper Trails," the illuminates undisclosed connections between key people involved in the review and the tobacco and e-cig industries.
These issues of conflict of interest, to say nothing of basing a “landmark” conclusion in e-cigarette safety on a single paper, are remarkable and call in to question the scientific credibility of Public Health England, the UK government, and everyone connected with preparing the larger report.   As someone who has been involved in many government reports as both a review and as a contributor I have never seen anything like this.
The reality is that, while there is a strong consensus, including me, that e-cigarettes exposure users to fewer toxins that conventional cigarettes, precisely how dangerous they are is nowhere close to settled.  For example, many of the effects of smoking (particularly in terms of heart disease) are nonlinear, with big effects at low levels of exposure and two things present in e-cigarette aerosol – ultrafine particles and strong oxidizing agents, are in e-cigarette aerosol, something not mentioned in the Nutt paper or the PHE report.  The precise risks are being studied now in several laboratories around the world. 
It is also important to keep in mind that e-cigarettes do not have to be all that dangerous (compared to cigarettes) to have a negative health impact at the population level.  Sara Kalkhoran and I recently published “Modeling the Health Effects of Expanding e-Cigarette Sales in the United States and United Kingdom: A Monte Carlo Analysis” in JAMA Internal Medicine that evaluated the likely health impact of expanding the e-cigarette market on public health over a wide range of possible (and at this time unknown) long term health risks associated with e-cigarettes.  This analysis suggested that, for one realistic possible future, the net public health impact of promoting e-cigarettes would be negative if they were more than 10% as dangerous as cigarettes and that they would and that the net health effects would be negative for other scenarios even if e-cigarettes were only 1% as dangerous as cigarettes.
As a first step to restoring its scientific credibility Public Health England should withdraw this report.



<img alt="" src="/sites/g/files/tkssra4661/f/u9/NHS%20ecig%20endorsement.jpg" width="355" height="473" /;It didn't take the e-cig companies long to start using the NHS to promote their products.
How long will it take similar messages to appear all over the world to sell e-cigarettes?
Again:&nbsp; The 95% safety estimate, produced by a group of individuals many of whom had financial ties with industry, is based on <em;no actual evidence.</em;
It will be interesting to see how NHS digs out of the hole that they have jumped in to.
(There is also a cautionary message for the US FDA as it ponders requests to label snus as less dangerous than cigarettes.)

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