Details Created on Wednesday, 04 December 2013 21:08

Scandalous propaganda from a pharmaceutical company Misinforming European Union in order to manipulate decisions on electronic cigarettes

By Dr Farsalinos

Although my job is focused on science, it is with regret that I have to make a comment for a political issue. However, this issue is of major scientific and public health importance. Few days ago I received an email informing me that a letter was sent from a pharmaceutical company to all MEPs (through a PR company). They presented evidence from a study by Bullen and coworkers, in order to support that nicotine levels in e-cigarettes should be decreased to 12 mg/ml. The letter is presented in public for the first time below:

Letter

Subject: Scientific Comment on the Commission Draft Compromise re Article 18 - trialogue negotiations on TPD

Dear

Bearing in mind the new proposed text on nicotine-containing products (Art. 18) recently drafted by the European Commission, we would like to share ……. Pharma’s additional input for the discussions on the Tobacco Products Directive.

……. Pharma understands that the new draft text is the result of the intensive negotiations and exchanges of views between the European Institutions over the past few weeks hence welcomes the proposal. ……. Pharma strongly believes that with a minor, scientific-based modification of the threshold to 12 mg/ml, the new text could lead to a balanced compromise between the EP, Council and Commission (which suggest 20mg/ml).

A recent scientific study, involving e-cigarettes with a total content of 16 mg has shown that e-cigarettes reduce the desire to smoke. A content of 16 mg can be expected to be achieved with a concentration limit of 12 mg/ml. It seems diligent to set a content limit applying a cautious approach considering that there is only very limited scientific evidence of the safety of e-cigarettes. Restricting the content to 12 mg/ml concentration will ensure that the delivery of nicotine to the user does not significantly surpass the amount delivered by medicinal products, thereby reducing the risk of short and long term unexpected adverse events. 12 mg/ml is considered a rational limit from a scientific and health perspective yet still allowing adult smokers a potential benefit of getting their nicotine from e-cigarettes.

We have taken the liberty to include a small video showing how ……. Pharma handles liquid nicotine in commercial scale manufacturing. It illustrates how liquid nicotine is appropriately handled based on it being as poisonous as Arsenic and Strychnin.





We remain at your disposal should you wish to raise any questions or comments on the above.

Thank you in advance for your consideration.

Kind Regards,

…….…….…….

On behalf of ………….

President and CEO

……. Pharma

End of letter

Several points arise from this letter. First of all, why is this company trying to influence the opinion and vote of MEPs? One would suppose that they have the scientific background to do it, and it is legitimate to inform the MEPs (who are not experts and are not supposed to know the science behind nicotine and e-cigarettes) about such issues. The problem is not that they have sent a letter. However, presenting half the data in order to distort the truth, including propaganda arguments (such as: “Nicotine – one deadly drop” and “being as poisonous as Arsenic and Strychnin”) and ignoring (whether literally or deliberately) recent scientific publications makes this a move of questionable ethics. It reveals that this pharmaceutical company is actively lobbying against the electronic cigarette. I wonder how many letters similar to this have been sent to MEPs and how this has influenced their perspective on e-cigarettes. I will not comment on the reasons for using such a strategy; however, it is my ethical obligation to reveal the whole scientific truth concerning the issues raised by the pharmaceutical company and to provide proper and reliable information to regulators. Below is the letter that we sent (see signatures at the end) to the MEPs, providing the whole truth about the nicotine issue.

Letter

Dear MEPs

We have been made aware of the letter below, which has been distributed in the European Parliament by lobbyists …….……. on behalf of ……. Pharma. In it, the latter makes a number of misleading claims about both nicotine and electronic cigarettes in the hope that MEPs will agree to reduce the amount of nicotine contained in these devices to the uselessly low level of 12mg/ml. It claims in the subject line of its email that this is a 'scientific comment'. We would suggest that it is anything but.

……. claims to be “the world's leading B2B supplier of nicotine replacement therapy” and we understand the desire of big pharma to protect its market. However, what it proposes would be bad for public health by banning most e-cigarettes on the market today, and completely unsupported by any scientific data. We would urge MEPs to side with science and with smokers desperate for an alternative to a product that will eventually kill half of them.

Electronic cigarettes

The study by Bullen et al. cited in the letter in fact showed that the 16mg e-cigarette delivered 40% less nicotine compared to the nicotine inhalator, as shown in Figure 1 below. The electronic cigarette’s effect in lowering desire to smoke was attributed to the sensory stimulation and the behavioral aspect of electronic cigarette use but not to nicotine delivery and absorption.

Figure 1. Nicotine absorption from tobacco cigarette, electronic cigarette and nicotine inhalator. Mean Cmax = peak nicotine concentration in plasma. Reproduced from: Bullen et al. Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial. Tob Control. 2010 Apr;19(2):98-103 (table 3).

It is questionable why medicinal nicotine products, which have failed as smoking cessation products, should be used as a guide for determining nicotine content in e-cigarettes as ……. Pharma suggests. Instead, tobacco cigarettes should be used as a guide and e-cigarettes should deliver nicotine in a way similar to tobacco cigarettes, unless we don’t want them to succeed in helping smokers switch from tobacco to e-cigarette use (which we are sure is not your intention).

As the study's authors concluded (see Figure 1 above), the 16mg e-cigarette delivered 10 times less nicotine to the user compared to tobacco cigarettes. This is unlikely to be viewed as satisfactory by users. An appropriate conclusion from this study would have been to suggest that the nicotine concentration in e-cigarette liquids be significantly increased in order to reach the levels delivered by tobacco cigarettes.

Nicotine's dangers: false claims from big pharma

As you may know, the issue of nicotine overdose or intoxication from electronic cigarette use is non-existent. The statement by …….about nicotine being as lethal as arsenic or strychnine has been proved to be nothing more but a myth,coming largely from dubious self-experiments over 150 years ago. A scientific review from Prof Bernd Mayer has shown that the lethal dose in humans is estimated to be between 500-1000mg (please see: Mayer B. How much nicotine kills a human? Tracing back the generally accepted lethal dose to dubious self-experiments in the nineteenth century. Archives of Toxicology 2013). Moreover, it is impossible for any user to get intoxicated from an e-cigarette, because users self-titrate their nicotine intake according to their own needs. That is why there has been no recorded nicotine overdose caused by electronic cigarette use since their introduction to the market.

A pharmaceutical company with longstanding experience in nicotine, like ……., is expected to know this information, but unfortunately they did not present it to you. Our job is not to evaluate why they have done so, but to properly inform you about the true implications and impact of the studies presented to you.

Yours sincerely

Prof Riccardo Polosa, Director of the Institute for Internal Medicine and Clinical Immunology, University of Catania, Italy

Dr Jacques Le Houezec, Consultant in Public Health, Rennes, France

Dr Konstantinos Farsalinos, Onassis Cardiac Surgery Center, Greece and University Hospital Gathuisberg, Belgium

End of letter

I am absolutely certain that MEPs are clever enough to realize the games played behind the back of vapers and smokers. We are dedicated in our efforts to reveal the truth concerning this sensitive public health issue, without hiding any facts, whether positive or negative for e-cigarettes. This is how we have proceeded so far, and this is how we will continue.

In case the news media ask for the name of the pharma company and the PR firm, i have no problem giving them all details.