TheNewsMonkey
Postman
- Joined
- Jan 8, 2013
- Messages
- 158
Sent by email 30th January 2013
Dear Ms Butter,
I hope you don’t mind my contacting you directly, only I am aware of a growing number of complaints to the PCC about your recent article in the Mail on Sunday “E-cigarettes ‘can cause more harm than smoking,’ experts say” from 26th January. My name is Katherine Devlin, and I am the President of the Electronic Cigarette Industry Trade Association (ECITA).
I have no wish to heap yet more criticism on you, but did wonder whether you would be interested in learning more about this subject. I hope that if you have an opportunity to write about electronic cigarettes again in the future, you will be better informed. I gather that you have been roundly attacked on Twitter (and elsewhere), which cannot be a pleasant experience. I have faced my share of online attacks over the years, so I can sympathise.
There is a vast amount of information out there on ecigs, and – understanding as I do how tight the deadlines are for journalistic pieces – it can be difficult to sort the wheat from the chaff. Obviously, I myself am necessarily biased, representing as I do the Industry itself, as well as the interests of the many hundreds of thousands of vapers in the UK, and the many millions across the EU and the world. So yes, I am conflicted, but I shall try to give you access to evidentially supported facts along with unbiased opinion pieces, so that you can make an informed decision for yourself. If this ultimately changes your view, obviously I would be pleased; if it does not, then at least I will have tried.
Remarkably, side effects commonly recorded during smoking cessation trials with drugs for nicotine dependence were absent (i.e. depression, anxiety, insomnia, irritability, hunger, constipation were not reported). Moreover, no serious adverse events (i.e. events requiring unscheduled visit to the family practitioner or hospitalisation) occurred during the study.”
http://www.biomedcentral.com/1471-2458/11/786
- Over the 3 months, the heart rhythm of the participants decreased.
- The level of exhaled carbon monoxide (CO) decreased in every case and reduced to nil/zero for vapers having stopped smoking.
- Weight gain was moderated. In cases of complete smoking cessation with continuation of vaping, weight gain was less than is usually noticed following smoking cessation.
- The forced vital capacity (FVC) improved with the use of the electronic cigarette, especially when there was significant reduction or total cessation of smoking.
- The maximum expiratory pressure per second (MEPS) was stable or improved slightly with the use of the electronic cigarette.”
(The above was taken from my own translation of the study, which French colleagues have confirmed is accurate. The full translation is available from my blog: http://www.ecita.org.uk/blog/?p=382. The original can be found here: https://docs.google.com/document/d/1R93I9PNgUODplREypnzdM-amwnLoDOJCl8Sxbm68ZeE/edit#)
“The problem with medicines regulation is that the categories that you were saying: ‘Licence this for recreational use’, those concepts don’t exist in medical regulation. There aren’t recreational medicines. There are only medicines that have a therapeutic effect, so if you put it into a medicines regulation framework, you have to show what the therapeutic effect is and prove that it’s effective. And therein lies the problem, because you’re then starting to treat in a different way. And the example I was using with colleagues earlier was alcohol. Now alcohol is a drug. It has a profound, sometimes very extreme, effect on the brain, it’s used for recreational purposes, but it’s not regulated via medicines regulation. It’s regulated via food safety regulations and a whole lot of specific things about labelling, which if you look on the back of a bottle of wine, or on a can of beer, you’ll see certain things about how much alcohol is in there, and how much you’re supposed to drink and not drink, and some warnings and so on, that are quite discrete but they nevertheless give you the information that you need. You also can’t sell alcohol in a way that’s dangerous: you can’t have methyl alcohol, you can’t have cans that explode in your face, and things like that.
So there are ways of regulating products that are dangerous, that have a drug effect that isn’t medicines regulation framework.”
“Clinical trials are not trials about product safety, basically. Clinical trials are done to measure whether there is a therapeutic effect. So you could imagine a clinical trial in which you have a control group of 100 smokers, you just say, well, quit cold turkey; you give 100 smokers nicotine patches; and you give 100 smokers e-cigarettes. And you see how they get on, and then you measure the results and that gives you what’s known as ‘therapeutic efficacy’. And that’s what clinical trials are generally used for.
The safety issues, well there are already safety regulations. One of the mad things about this is that most products have to be safe. You can’t just put any old dangerous killer product on the market in Europe. There’s things called the General Product Safety Regulations which says that a product has to be safe. There is regulations that say that products generally have to be fit for purpose. So there’s already regulatory frameworks for dealing with ordinary dangerous products. So for example the General Products Safety Regulations cover things like cigarette lighters, which is a little canister of inflammable liquid, which we pass around. So it’s not as if there aren’t already regulatory arrangements that could deal with some of this stuff, if they were applied properly to ecigarettes. And if you need specific regulations to deal with the product, then you can make those up.”
I am confident that it was never your intention to give bad advice to your readers, but unfortunately, this is what has happened. I hope the above information is useful; much, much more is available. The fundamental point is this: telling smokers that their smoking is less harmful to them than switching to a smoke-free alternative is not only entirely inaccurate, but very, very dangerous. As Dr Carl Phillips said:
“for the average smoker, smoking for just one more month before quitting causes greater health risk than switching to a low-risk nicotine source and never quitting it. Thus, discouraging a smoker, even one who would have quit entirely, from switching to a low-risk alternative is almost certainly more likely to kill him than it is to save him.”
http://www.harmreductionjournal.com/content/pdf/1477-7517-6-29.pdf
(cited in http://www.ecita.org.uk/docs/Letter_to_Mail_Online_ 060912.pdf)
Please, please, before giving any further advice to the public about their health – which is what your article amounts to – please look into the evidence base, to inform your position. If you would like to discuss any of these issues, please do not hesitate to contact me directly. I can be reached on ***********, or by email as above.
Yours sincerely,
Katherine Devlin
President
ECITA (EU) Ltd
www.ecita.org.uk
Update From ECITA
Dear Ms Butter,
I hope you don’t mind my contacting you directly, only I am aware of a growing number of complaints to the PCC about your recent article in the Mail on Sunday “E-cigarettes ‘can cause more harm than smoking,’ experts say” from 26th January. My name is Katherine Devlin, and I am the President of the Electronic Cigarette Industry Trade Association (ECITA).
I have no wish to heap yet more criticism on you, but did wonder whether you would be interested in learning more about this subject. I hope that if you have an opportunity to write about electronic cigarettes again in the future, you will be better informed. I gather that you have been roundly attacked on Twitter (and elsewhere), which cannot be a pleasant experience. I have faced my share of online attacks over the years, so I can sympathise.
There is a vast amount of information out there on ecigs, and – understanding as I do how tight the deadlines are for journalistic pieces – it can be difficult to sort the wheat from the chaff. Obviously, I myself am necessarily biased, representing as I do the Industry itself, as well as the interests of the many hundreds of thousands of vapers in the UK, and the many millions across the EU and the world. So yes, I am conflicted, but I shall try to give you access to evidentially supported facts along with unbiased opinion pieces, so that you can make an informed decision for yourself. If this ultimately changes your view, obviously I would be pleased; if it does not, then at least I will have tried.
- Propylene glycol has been studied for safety since the 1940s. It has been classified as GRAS (Generally Regarded As Safe) for decades.
- Clinical studies into electronic cigarettes have shown no serious adverse effects:
Remarkably, side effects commonly recorded during smoking cessation trials with drugs for nicotine dependence were absent (i.e. depression, anxiety, insomnia, irritability, hunger, constipation were not reported). Moreover, no serious adverse events (i.e. events requiring unscheduled visit to the family practitioner or hospitalisation) occurred during the study.”
http://www.biomedcentral.com/1471-2458/11/786
- A recent French study also considered effects on health:
- Over the 3 months, the heart rhythm of the participants decreased.
- The level of exhaled carbon monoxide (CO) decreased in every case and reduced to nil/zero for vapers having stopped smoking.
- Weight gain was moderated. In cases of complete smoking cessation with continuation of vaping, weight gain was less than is usually noticed following smoking cessation.
- The forced vital capacity (FVC) improved with the use of the electronic cigarette, especially when there was significant reduction or total cessation of smoking.
- The maximum expiratory pressure per second (MEPS) was stable or improved slightly with the use of the electronic cigarette.”
(The above was taken from my own translation of the study, which French colleagues have confirmed is accurate. The full translation is available from my blog: http://www.ecita.org.uk/blog/?p=382. The original can be found here: https://docs.google.com/document/d/1R93I9PNgUODplREypnzdM-amwnLoDOJCl8Sxbm68ZeE/edit#)
- The MHRA has licensed a Nicorette product called ‘QuickMist’ (http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con194682.pdf) which delivers an aerosol of propylene glycol, vegetable glycerine, nicotine and flavouring. Indeed, the MHRA has described nicotine as “a very safe drug”. (http://www.mhra.gov.uk/home/groups/es-policy/documents/publication/con065618.pdf.)
- Clive Bates, former Director of ASH UK, describes why medicines regulation is neither necessary nor desirable for electronic cigarette products in this video:
“The problem with medicines regulation is that the categories that you were saying: ‘Licence this for recreational use’, those concepts don’t exist in medical regulation. There aren’t recreational medicines. There are only medicines that have a therapeutic effect, so if you put it into a medicines regulation framework, you have to show what the therapeutic effect is and prove that it’s effective. And therein lies the problem, because you’re then starting to treat in a different way. And the example I was using with colleagues earlier was alcohol. Now alcohol is a drug. It has a profound, sometimes very extreme, effect on the brain, it’s used for recreational purposes, but it’s not regulated via medicines regulation. It’s regulated via food safety regulations and a whole lot of specific things about labelling, which if you look on the back of a bottle of wine, or on a can of beer, you’ll see certain things about how much alcohol is in there, and how much you’re supposed to drink and not drink, and some warnings and so on, that are quite discrete but they nevertheless give you the information that you need. You also can’t sell alcohol in a way that’s dangerous: you can’t have methyl alcohol, you can’t have cans that explode in your face, and things like that.
So there are ways of regulating products that are dangerous, that have a drug effect that isn’t medicines regulation framework.”
“Clinical trials are not trials about product safety, basically. Clinical trials are done to measure whether there is a therapeutic effect. So you could imagine a clinical trial in which you have a control group of 100 smokers, you just say, well, quit cold turkey; you give 100 smokers nicotine patches; and you give 100 smokers e-cigarettes. And you see how they get on, and then you measure the results and that gives you what’s known as ‘therapeutic efficacy’. And that’s what clinical trials are generally used for.
The safety issues, well there are already safety regulations. One of the mad things about this is that most products have to be safe. You can’t just put any old dangerous killer product on the market in Europe. There’s things called the General Product Safety Regulations which says that a product has to be safe. There is regulations that say that products generally have to be fit for purpose. So there’s already regulatory frameworks for dealing with ordinary dangerous products. So for example the General Products Safety Regulations cover things like cigarette lighters, which is a little canister of inflammable liquid, which we pass around. So it’s not as if there aren’t already regulatory arrangements that could deal with some of this stuff, if they were applied properly to ecigarettes. And if you need specific regulations to deal with the product, then you can make those up.”
- ASH recently produced an updated briefing, setting out the organisation’s position on electronic cigarettes: http://ash.org.uk/files/documents/ASH_715.pdf
I am confident that it was never your intention to give bad advice to your readers, but unfortunately, this is what has happened. I hope the above information is useful; much, much more is available. The fundamental point is this: telling smokers that their smoking is less harmful to them than switching to a smoke-free alternative is not only entirely inaccurate, but very, very dangerous. As Dr Carl Phillips said:
“for the average smoker, smoking for just one more month before quitting causes greater health risk than switching to a low-risk nicotine source and never quitting it. Thus, discouraging a smoker, even one who would have quit entirely, from switching to a low-risk alternative is almost certainly more likely to kill him than it is to save him.”
http://www.harmreductionjournal.com/content/pdf/1477-7517-6-29.pdf
(cited in http://www.ecita.org.uk/docs/Letter_to_Mail_Online_ 060912.pdf)
Please, please, before giving any further advice to the public about their health – which is what your article amounts to – please look into the evidence base, to inform your position. If you would like to discuss any of these issues, please do not hesitate to contact me directly. I can be reached on ***********, or by email as above.
Yours sincerely,
Katherine Devlin
President
ECITA (EU) Ltd
www.ecita.org.uk
Update From ECITA
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