A Freedom of Information request was sent recently to the UK Medicines and Healthcare products Regulatory Agency (MHRA) asking for data on reports of adverse effects of nicotine.
The MHRA has an online system called Yellow Card scheme https://yellowcard.mhra.gov.uk/ where anybody can report any adverse effects they have suffered through taking a medicine or which have been reported by doctors or other health professionals. The MHRA is also responsible for collecting data on adverse reactions to e-cigarettes even though the products are not classified as medicines.
The results make interesting reading. Between 2012 and October 2018, there were 666 discrete adverse reactions reported regarding ten NRT products including six fatal adverse reactions. Note, and see the caveat below, that the reporting system does not establish the veracity of the alleged reactions report – including death! For those theologians among you, you will know that in the Old Testament Book of Revelations, 666 was the mark of the Beast, aka Satan.
This compares to only 69 adverse reactions spread among 40 different e-cigarette products over the same time period with no fatalities reported.
The top adverse reactions for NRT were (surprisingly) psychiatric disorders followed by ‘general disorders’ (which covers a whole range of generalised conditions such as skin problems, pain and subjective ‘feelings’) and gastrointestinal problems which also figured at the top for e-cigarettes along with respiratory issues. There were 19 ‘adverse reaction’ reports that NRT wasn’t effective.
The MHRA made these important caveats about the data:
“It is important to note that a report of a suspected reaction to a medicine or e-cigarette via the Yellow Card Scheme does not necessarily mean that the reaction has been caused by the product. It must be understood that suspected adverse reactions are just suspicions that a product may have caused a reaction and the reporting of a suspected adverse reactions is not proof of an association. Many factors have to be taken into account in assessing causal relationships including temporal association and any underlying or undiagnosed illness. In addition, please note that it is not possible to calculate the incidence of adverse reactions from the data provided. This is because the level of reporting can be influenced by many factors and so comparisons of absolute numbers may be invalid”.
So a number of caveats around these results, not least one assumes there must be more NRT than e-cigarette users in the UK, but food for thought nonetheless.
As highlighted by Clive Bates, all power to Kenneth Warner and David Mendez for this tasty academic spat over the questionable contention that flavour plays no part in helping adults quit smoking, they simply attract kids to vape. Click below for the full story
“Warner and Mendez take no prisoners in their response to criticisms by Ward-Peterson and Maziak of Warner & Mendez' original work.”
This is a letter written by John Hughes and colleagues on why they choose to work with the tobacco industry over tobacco harm reduction. They were replying to Wayne Hall’s view about finding alternative sources of funding and is very relevant to the whole issue of the Foundation for a Smoke Free World funding the Global State of Tobacco Harm Reduction report:
Even with taxation, smoking restrictions, mass media, stigmatization, etc., the prevalence of smoking is decreasing by less than 1%/year. Attempts to eradicate drugs well-established in a culture have rarely been successful; e.g. despite all our efforts, only half of US smokers have quit. Given this, we believe it necessary to accept intermediate goals such as use of reduced risk products for some smokers. We believe the weight of the evidence indicates the availability of harm reduction products does not undermine motivation for tobacco cessation and may improve public health. If the tobacco industry seeks to make money by marketing reduced risk products instead of more risky products, we fail to see this as a menace to public health. We believe industries’ investment in less-risky products is a clear sign they recognize their survival depends on such products. This shift is actually a tobacco control success story.
In the current climate, the industry is in a classic Catch-22 situation. If they perform their own research, many journals will not believe it no matter its scientific merit. However, if the industry attempts to sponsor independent research on a reduced risk product, this is hampered by the fact that independent scientists who undertake such research are stigmatized. For example, several of us have had to withdraw from presenting at meetings, serving on tobacco control boards, etc. due to working with the tobacco industry.
The 18th October was designated as William Harvey Day to celebrate the work of the 17th-century English doctor who did pioneering work in anatomy and physiology, by showcasing cutting-edge UK medical research. One of the guest lecturers was Prof Martin McKee whose topic was ‘Medicine in an era of fake news’. Hold that thought. Flash back to a few weeks earlier when this very same Prof was interviewed by First News, a UK newspaper aimed at young school children aged 7-14. The article was headed ‘Flavour Danger’ and purported to be reporting factual information about e-cigarettes to young readers. There isn’t enough room here to log the inaccuracies and misleading information that littered the whole piece, but Planet of the Vapes was on the case with a scathing tear down;
The guy who actually wrote up the interview for First News contacted POTV asking what credentials the author had to write such an attack given that the information came from such an esteemed personage as Prof McKee. Back came the reply – no credentials at all, but if you want ‘credentials’, how about the whole alphabet soup of medical agencies that would regard McKee’s comments as totally unfounded – like maybe PHE, RCP, BMA, NHS, and ASH. According to McKee, unnamed ‘people’ find the evidence-based views of PHE and RCP ‘bizarre’. Well, we can all guess who they might be. A Campaign for McKee Free Kids anyone?
And just a final word about a recent online discussion about the use of words like addiction and dependence when talking about nicotine. I think this is a very important issue and one that will be the theme of the 2019 GFN Conference in Warsaw. In light of the total lack of credible population-level evidence of acute or chronic physical health effects from safer nicotine products such as e-cigarettes, those opposed to tobacco harm reduction fall back on the addiction trope with all the connotations in the public mind normally associated with serious drug problems. In terms of risk communication even to a relatively well-informed health audience, let alone legislators, policy makers and politicians who generally don’t understand the difference say between addiction and habit – it is very important to change the narrative on nicotine as part of the effort to inform future regulation and control.