ECITA Blog

16^th January 2013

To: Dr Tonio Borg

Commissioner for Health and Consumer Policy

Dear Dr Borg,

Re: Proposed revisions to the Tobacco Products Directive

I should like to offer my congratulations on your appointment to this most important office, and hope that you will use your position to insist on robust evidence and unimpeded, unbiased expert opinions when making significant policy decisions which will affect the health and well-being of every citizen of the European Union.

Turning these consumer products into medicinal products would require a significant loss in the performance of the products. They would be required to deliver controlled doses, which would make them more like the medicinal nicotine inhaler than like a tobacco cigarette. Millions of EU citizens want and need a safer alternative to the tobacco cigarettes they are smoking. Non-medicinal electronic cigarettes can provide this; medicinal electronic cigarettes cannot. These products are appealing to and working for millions of EU smokers; why would the Commission want to “slow the pace”?

It would be a wasted opportunity not to offer smokers an appealing alternative to their cigarettes. Of financial necessity, regulation as a medicine would effectively eliminate flavourings, since each one would have to be licensed individually. It would also stifle the development of new and better models of electronic cigarettes, which smokers desperately need.

It is quite incomprehensible – not only to me, but to a wide range of public health experts with no connection to the electronic cigarette industry at all (see Appendix 1) – that the Commission should seek to put such restrictions on a consumer product which is currently helping many millions of EU citizens stay away from tobacco smoking by switching to using electronic cigarettes instead.

Does the Commission plan to revise the definitions of a medicinal product, as set out in Directive 2001/83/EC? If so, what is the justification for doing so? If not, how can electronic cigarettes be reclassified as medicinal products?

It seems ironic in the extreme that the proposal itself cannot be “justified by overriding reasons of public interest” and is neither “necessary” nor “proportionate”. Rather the proposed revisions to the Tobacco Products Directive appear to be precisely “a means of arbitrary discrimination” and “a disguised restriction on trade between the Member States”.

The simultaneous inclusion and exclusion of electronic cigarette products, combined with the attempt to reclassify some electronic cigarettes (but not others) as medicinal products (despite the legal challenges to this), would result in the significant inhibition of the free trade of electronic cigarette products within the European Union. No justification has been provided for this within the proposal.

Electronic cigarette products not designed as medical treatments for smokers, and not making medicinal claims, cannot be deemed medicinal products, as demonstrated in the various court rulings. In reality, the ‘level playing field’ for the internal market would be inappropriately ‘skewed’ in favour of the Pharmaceutical and Tobacco Industries if non-pharmaceutical and non-medical products were to be reclassified as medicinal products, in order to protect their interests at the expense of the Electronic Cigarette Industry.

The impact assessment also states: “Today, there are two categories of products containing nicotine available on the market: NCP placed on the market without any prior control and NRT (Nicotine Replacement Therapies) which have been subject to a strict (and relatively costly) risk/benefit analysis and approved as medicinal products.”

There are several inconsistencies and errors in this statement, not least that it leaves out the most obvious, and most widely available third ‘category of product containing nicotine’, namely tobacco cigarettes. These have not been ‘subject to a strict (and relatively costly) risk/benefit analysis’, so where is the justification for applying such a burdensome regulatory framework to electronic cigarettes?

If the fact that a product contains nicotine is all that is necessary for it to qualify as a medicinal product, then where are the draft proposals from the Commission that tobacco products – all of which contain nicotine – should have to undergo the “strict (and relatively costly) risk/benefit analysis” and gain approval as medicinal products. Where, exactly, does the need for a ‘level playing field’ start and end?

As David Sweanor, Adjunct Professor of Law at the University of Ottawa pointed out recently: “…the massive and numerous lawsuits against cigarette companies are not a result simply of them being cigarette companies, but rather a result of a failure to live up to their duty to consumers.”

How much greater is the duty of public officials, with a specific remit for protecting public health, to the citizens whose lives they seek to shepherd? The reputation of the Commission is, indeed, at stake. We trust you will not wish to make policy which would have such a devastating negative effect on the citizens whose health protection is your specific responsibility.

Thank you for your time and consideration.

Yours sincerely,

Katherine Devlin

President

ECITA (EU) Ltd

(The full text of our letter, together with appendices and references is available from our website.)

Forgive the long silence – we’ve been locked in the cellar, working hard on researching the ins and outs, ups and downs, and twists and turns of the revisions to the Tobacco Products Directive. More to follow on this soon….

Today, though, I want to share with you the findings of a recent French study on electronic cigarettes, published at the end of November 2012. Although limited (as so many such studies are, unfortunately) to a relatively small number of smokers, it does, nevertheless, have useful information, particularly concerning the safety profile of electronic cigarettes – yet more grist to the mill for the fight against those policy makers who claim to have concerns about the safety profile of electronic cigarettes, with NO evidence to support this position.

I have only had access to the abstract, and have done my best to translate it into English, despite having forgotten how English works during the process(!), so please forgive any ‘peculiar’ turns of phrase. Also, the abstract didn’t include any graphics, but I’ve added a few pie charts, to help demonstrate the significance of the findings.

Observations on acceptance of the electronic cigarette

Results at three months

Dr Jacques Granger – Departmental Committee of Respiratory Diseases of the Dordogne

Dr Brigitte Cornette – Centre for Health Examination of Périgueux

Published 30^th November 2012

The electronic cigarette or ‘e-cigarette’ replicates the sensations of tobacco smoking. The electronic cigarette only contains some nicotine, a vaporising liquid and flavourings while tobacco smoke contains approximately 4000 toxic substances, of which at least 50 are carcinogenic. It consists of an electronic vaporiser known as an ‘atomizer’, a battery and a reservoir holding the liquid (named ‘e-liquid’) for vaporisation. The mixture of vapour and air is inhaled then exhaled in a ‘cloud’, simulating tobacco smoke, which quickly dissipates. As there is no combustion thus no smoke, it is said that the consumer ‘vapes’.

The lack of clinical studies for the approval of the electronic cigarette does not allow its authorisation “as a medicinal product” for the cessation of smoking. This has not prevented numerous smokers from using it.

The Departmental Committee of Respiratory Diseases of the Dordogne therefore wished to observe the use of the electronic cigarette, in conjunction with the Centre for Health Examination of Périgueux. This Centre provides smoking cessation services and supplied, from their team, a doctor and a nurse qualified in providing prevention and educational advice on tobacco addiction.

OBJECTIVES, METHODS AND PROGRESS

Objectives

The main objective was to estimate the acceptance and the tolerance of the electronic cigarette by smokers:

1. conscious of the need to reduce the risks of smoking for their health,
2. having unsuccessfully already tried to stop smoking,
3. expressing no desire to stop smoking for the moment.

The secondary objective was to get the smoker to think about their dependence and to lead them, possibly, towards a later attempt at complete smoking cessation.

Methodology

It was suggested to 100 smokers, who declared they did not wish to stop smoking at the moment, to use an electronic cigarette for three months. The instruction was to ‘vape’ instead of smoking, eventually replacing their smoking with vaping.

Measurements of weight, heart rhythm, spirometry and the level of expired carbon monoxide (CO) were taken at the beginning of the study and at the end of three months by the Centre for Health Examination. A follow-up, by questionnaire and telephone, in six months then in one year is planned.

Number studied

The recruitment was made by selection of smoking volunteers who:

· had benefited from a health examination at the Centre for Health Examination,
· or had participated before unsuccessfully in a program of smoking cessation,
· or were under consultation with the partner pulmonologists of the study.

In the group:

· all were smokers for more than 10 years.

· 83% were situated in the age bracket 25-59 years.

· 52% were smokers of 20 cigarettes and more a day; 98% were smokers of ten cigarettes or more.

· 70% began to smoke before the age of 18 years, and 30% before the age of 15 years.

· the Fagerström score was upper or equal to 4 for 76% of the participants; for 30%, the score was 7 or more.

Progress

Over three months, subjects were provided with different entry level e-cigarettes free of charge, generating the vapor by simple inhalation. At the beginning, the participants had disposable then later refillable models, with the flavour ‘light tobacco’ and a nicotine content of 11mg/ml (1.1%) or 16mg/ml (1.6%).

OBSERVATIONS AT THREE MONTHS

The observations below are universal and do not take into account the differences of equipment, nicotine levels and flavours.

Acceptance of the electronic cigarette

Seventy-four participants were followed over three months. The given product not satisfying them, or because they were no longer interested, 26 persons stopped participating, of which 17 stopped during the first month.

Cessation of smoking

Although it was about persons who did not initially envisage complete cessation, eight participants (11%) had stopped smoking totally during the assessment at three months. Almost all of these stopped from the first days, by using the e-cigarette until the 3rd month for 7 of them (with complete cessation of both smoking and the e-cigarette for one participant).

This total cessation of smoking is especially noticeable for the smokers of between 11 and 20 cigarettes a day, not particularly for the smokers of less than ten cigarettes. Some subjects previously smoked more than 20 cigarettes a day.

Reduction of smoking (dual use)

Among those having alternated vaping and smoking of cigarettes, all decreased their smoking:

· 45 (68%) having decreased their tobacco consumption by more than 50%
· 21 (32%) having decreased their consumption by less than 50%

Satisfaction following the use of the electronic cigarette

Concerning the sensation of cravings, with vaping:

· the sensation of cravings was not felt in 34% of the cases,
· the sensation of cravings was moderated in 38% of the cases,
· the persistence of cravings was declared in 27% of the cases.

For 91% of the participants, the handling or ‘feel’ of the electronic cigarette differed from that of the tobacco cigarette (by the weight, the feel or the texture).

The electronic cigarette achieved a majority of favourable opinions from the non-smokers, both in the family environment and in public or at work.

Effects on health

· 64% of the persons having used the electronic cigarette noticed positive effects on their health. 15% indicated minor side effects (mouth, lips or throat irritated).

· 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.

Future intentions

After three months of regular use of the electronic cigarette (n=74):

· 8% wished to resume tobacco smoking and stop using the electronic cigarette
· 9% wished to stop smoking and continue only vaping
· 28% wished to stop both smoking and vaping
· 45% wished to continue both

Additional observations are expected in the 6th and 12th month following this study.

The average grade for satisfaction of the participants in the study is 9.5/10

Limitations of the study

In terms of the limitations of this study of the acceptance of the electronic cigarette, it is to be noted

· the number of participants was too limited to ensure statistical meaning,
· the absence of a control group for comparison,
· the variety of the supplied devices,
· and the restricted choice of flavourings and nicotine levels.

CONCLUSION

The use of the electronic cigarette achieved a significant reduction in smoking for 72% of the smokers.

Among 74 participants followed for three months, 53 strongly decreased their consumption of cigarettes (72%, confidence interval 95%: 60% – 84%), and eight (11%) totally stopped smoking. The rest of the participants also declared to have decreased, but less than 50%.

The electronic cigarette was well accepted, both by the participants and by their circle of acquaintances (family, in public or at work). Two thirds of the subjects having used the electronic cigarette noticed positive effects on their health.

Although based on a limited sample, this first study undertaken in France confirms the potential of the electronic cigarette for the protection of the health of smokers, whether they intend to quit smoking or not. We cannot recognise that tobacco smoking is the leading cause of preventable deaths in France and in the world, and at the same time, make no study of the electronic cigarette, acclaimed by millions of users concerned about their health.

This study of one hundred smokers allows us to anticipate other, more thorough studies. There was a large number of volunteers and favourable elements of health improvement were observed over three months without any significant problems.

Conflicts of interest: None.

Contact :
Dr Jacques Granger
Comité Départemental des Maladies Respiratoires
Centre hospitalier – Service de Pneumologie
80, avenue Georges Pompidou
CS 61205 24019 PÉRIGUEUX Cedex
docteur.jgranger@wanadoo.fr

You can find the original abstract, in French, here.

I can’t help but think that by far the most significant findings of this study are the effects on health. Bear in mind that at least some of the subjects observed were currently receiving treatment from consultant pulmonologists, i.e. smokers with existing respiratory health problems. Leaving aside the rather nebulous claim of ‘64% noticing positive health effects’, the very specific measurements taken from each subject at the start of the study, and after the 3 months, show very definite health improvements, directly attributable to the use of the electronic cigarette. Just to reiterate these important findings:

• Heart rhythm decreased;
• Carbon monoxide levels decreased in every case, and reduced to zero for vapers having stopped smoking;
• For those subjects who switched from smoking to vaping, weight gain was less than is usually noticed following smoking cessation;
• Both forced vital capacity (FVC) and maximum expiratory pressure per second (MEPS) – both very significant measures for sufferers of asthma, COPD and other lung impairments  – improved (and/or were stable, in the case of MEPS) with the use of the electronic cigarette.

As Michael Siegel pointed out recently:

“In my opinion, electronic cigarette companies which are claiming that use of their products reduces the health risks associated with cigarette smoking are making factual statements for which there is plentiful scientific evidence.”

and

“It is now clear that electronic cigarettes are reduced harm products (compared to conventional cigarettes). Anyone who continues to claim that there is no scientific basis for such a claim is either lying or living in a secluded cave without internet access.”

As far as I’m aware, at the time when Professor Siegel wrote that, he was not aware of the French study, but was discussing the Schripp study on the vapour, which also supports the safety profile of electronic cigarettes.

The evidence is mounting – and it is ALL in favour of electronic cigarettes.

Right: time to collate the evidence and write to the Commission. Watch this space!

First published on 18th October 2012

For the love of money is the root of all evil: which while some coveted after, they have erred from the faith, and pierced themselves through with many sorrows.”

1 Timothy 6:10, King James Version

What a turbulent year this has been! It seems that every day there is another tale of bad behaviour, public enquiries, internal investigations, inglorious resignations, spectacular sackings… and apparently no area of society remains unaffected. Politicians’ expenses scandals, banking institutions crumbling under the weight of their own greed (and appearing to do their best to bring the rest of the world down with them!), police forces facing inquiries, the media under special scrutiny, teachers falling in love with pupils, care homes abusing the elderly, child abuse in the Church… and the list goes on: a sad but true reflection of a world which seems intent on destroying itself.

Is there a ray of hope anywhere, amidst all this doom and gloom? Is it possible to trust anyone anymore? Or is King Greed in charge now, with his consorts, Intrigue and Corruption. These consorts are beautiful and seductive. Can we resist them? It is hard. Salacious stories sell.

The internet has been a powerful force for good, but the resulting transparency and access to incomprehensible quantities of information has, I believe, eroded our trust in all those institutions on whom we used to rely.

And what is the impact on public health? And more particularly, what is the impact on the development of public health policy? For this is, surely, the starting point if there is any hope for improvement, even if mistakes are made along the way.

Owing to the publicised court cases involving the Tobacco Industry in the past (or ‘Big Death’, if you prefer), we now know much of the full extent of the lies, the cover-ups, the back-handers, etc. It is not a pretty picture. But then, few people outside of that industry were surprised to learn that they were not the mighty force for good they once touted themselves to be! In March this year, the New Tobacco Atlas estimated that the Tobacco Industry profits were up to US$35 billion. On the surface, to many, that would look like ‘success’.

Until you consider that, by this measure, the cost of this ‘success’ was almost 6 million annual deaths.

The Pharmaceutical Industry came to the fore, offering products to help people quit smoking, in the form of Nicotine Replacement Therapies (NRT), and tablets designed to ‘muddle’ the brain and make it block out the craving for a smoke. This market has been very ‘successful’ too, if one measures success by market share, and profits. But how successful has it been in more important terms, such as in contributing towards saving some of those 6 million annual deaths? Well, with a long-term successful quit rate of 7% at best, not very. According to a recent Harvard study, one of the authors reported:

“No difference in quitting success with use of NRT was found for either heavy or light smokers.”

Indeed, this market has actually ‘contributed’ a few thousand more deaths – in almost equally awful and distressing ways, with the suicides and other neuropsychiatric events reported (and now warned against) caused by varenicline (marketed as ‘Chantix’ and ‘Champix’).

And this, unfortunately, is where we must begin to examine some of the insidious goings on behind the scenes in these large corporate industries. Last week saw the resignation of former European Commissioner for health, John Dalli. I blogged about it – rather harshly, I admit, although with no apology, for the kind of behaviour indicated by the reported events leading up to the OLAF pronouncement is utterly reprehensible and repugnant.

It seems that what should have been a shining example of ‘good behaviour’ coming from Big Death – in the form of smokeless tobacco products, with an undoubtedly far better public health profile – was involved up to its elbows in seeking to ‘buy’ favourable policy from the then Commissioner Dalli. That, of course, is if we can believe the email from Inge Delfosse, published by Malta Today, asking how much Silvio Zammit would charge in return for arranging an informal meeting to discuss the “bad rumours flying around Brussels”.

However, if we are to get to the facts of the case, we must remember that this email should be set in context, not plucked out in isolation for scrutiny. We do not know what the rest of this correspondence may have contained. Nor do we know to what extent, if any at all, Dalli was aware of such correspondences.

Indeed, as was pointed out in one of the comments on the Malta Today article:

“The subject of this email is “Re: proposal”. So where is the email with the subject “proposal” and who sent that? Just would like the full story, not trying to jump at any conclusions.”

Jumping to conclusions will not help us get to the bottom of this, or any of these machinations of the seductive Intrigue; we must seek out the full facts.

I first met Inge Delfosse in April 2010, at the IHRA conference in Liverpool, UK. She seemed nice enough, and the smokeless advocates clearly had an important message: rely on the science to inform decisions. And certainly, the evidence is well and truly in for snus – it works, and is far, far safer than smoking. Sweden’s results are astonishing, so clearly it seemed a bad idea for these products to be restricted. And yet, I begin to see why policy-makers and public health advocates have been so reluctant to trust that the Tobacco Industry might have done something ‘good’.

While in Liverpool, I had the opportunity to spend some time with a truly wonderful gentleman, by the name of Dr Adrian Payne. ECITA was in its infancy at that stage. He said the reason that the final doors in Brussels had remained closed to snus was simply because it came from the Tobacco Industry. He also recognised (as I always have) that the US electronic cigarette industry has done itself – and public health – a significant disservice in pushing for classification as a tobacco product, rather than a medicinal product.

Its proper classification, of course, is where it currently sits – as a consumer product, properly safeguarded by the wealth of regulatory legislation which covers every product ever conceived, and any product awaiting development in the future, which does not naturally fall into any other specific classification. This is the best ‘fit’, and the best way to ensure the widest possible dissemination of this harm reduction opportunity, in the safest and most accessible way. More on this in future reports….

Dr Payne had already recognised the enormous promise for harm reduction offered by electronic cigarettes, and he advised me to ensure that we remain entirely separate from the Tobacco Industry. I have never forgotten that advice.

Indeed, the electronic cigarette industry has come from outside both the Tobacco and the Pharmaceutical Industries, and has grown in its own right. But now that we have done so, of course, these large enterprises – whose market shares are equally adversely affected – are ‘buying in’. I cannot begin to express my disappointment at this.

Inge Delfosse contacted me before the Commission’s stakeholders’ meeting in March this year, suggesting I might like to join her and her colleagues for a “pre-meeting to clarify approach etc.” She suggested that she could see “some advantages” were I to attend. Frankly, I could see no such ‘advantages’, and indeed, at the meeting, I made it very clear where the dividing lines were and are. (My report on this meeting is publicly available here.) Very persuasive attempts were made to draw me into supporting the Smokeless Lobby’s position in the stakeholders’ meeting, but I reiterated my position that we remain absolutely separate from any part of the Tobacco Industry, with the only common ground being our wish to see a reliance on genuine scientific evidence.

I concluded in my blog on Dalli’s resignation:

“the undeniable reality of this whole sordid mess is that the Commission’s revisions to the Tobacco Products Directive have been utterly derailed. Indeed, the damage may even go far wider than just this, but surely at the very least, the Commission ought to scrap the existing consultation as entirely besmirched by these events, and start again, with the focus properly on public health and scientific evidence? One wonders how else they can possibly proceed, if they are to regain any of the credibility they have so publicly lost.”

Regrettably, it begins to look increasingly as if this is precisely what the Tobacco Industry set out to achieve, when Inge Delfosse sent that email, and then Swedish Match reported these events to the Commission. It is difficult to see how the current revisions to the Tobacco Products Directive could be concluded without parties from both extremes likely to cry ‘foul’ about the end result. Indeed, up to this point, we ourselves had grave concerns that there was undue influence coming from the Pharma lobbies into Mr Dalli’s deliberations! Oh, what a tangled web….

ECITA must do whatever we can to ensure that access to electronic cigarette products is as unrestricted as possible (always with the proviso that the appropriate regulations must be rigorously enforced), but, despite our having no desire to be ‘tarred with the same brush’ (pun intended!) as Big Death, we almost seem to end up on the same side!

But is the Pharmaceutical Industry any less morally reprehensible?

In WhyQuit News, John Polito suggests that Pharma bias is deliberately interfering in scientific research – and unfortunately, this is not news. In Science-Based Medicine, Steven Novella reported the US$3 billion fine paid by GSK recently, and described it as:

“the most recent evidence that industry cannot be left to their own devices without proper monitoring and regulation.”

(Many of the comments left in response also make very interesting reading.)

And of course, we cannot complete this examination of these issues without mentioning Pfizer’s current challenges over its ‘brain-muddling’ drug Chantix. Perhaps the most regrettable aspect of this is that these are but two among the many examples of illegal and morally repugnant behaviour by Big Pharma.

Many and varied are the accusations against even the Tobacco Control lobby itself, so how can we know where to turn? Dr Carl Phillips makes some interesting observations on this in his blog. Is it possible to find a small part of the human consciousness which is not corrupted by greed and selfishness?

At the start of this somewhat dark and depressing journey, I asked the question: Is there a ray of hope? Surely, the light at the end of the tunnel must be, simply the truth.

The electronic cigarette industry has not yet achieved the Big Industry status to which it will surely grow. However, in its earliest beginnings, I have personally seen that, alongside an entirely healthy wish to ‘succeed’, and build a profitable business – which can contribute to the economic growth of the country, offer employment, and yes, make money – it is possible to have a true ethical underpinning. The members of ECITA, together with many others in this industry, are proud to be able to offer for sale a product which can really make a difference in the lives of their customers. I hope that they will never lose sight of this, as their businesses grow, and they achieve ever greater successes.

For the sake of complete transparency and honesty, and for the avoidance of doubt (if that is possible, in this world of noise and confusion), full information on my background and conflicts of interest can be found here.

Whether it be corrupt politicians, corrupt corporations, or both intertwined, public health advocates have a moral obligation to root out the truth and expose it, with the specific intention of ensuring that better public health policy decisions can be made.

And ye shall know the truth, and the truth shall make you free.

John 8:32, King James Version

In a press statement published today at 4.30pm, the European Commission announced the resignation of Commissioner John Dalli, with immediate effect.

“Mr Dalli informed the President of the European Commission Jose Manuel Barroso of his decision following an investigation by OLAF, the EU’s antifraud office, into a complaint made in May 2012 by the tobacco producer, Swedish Match. The company alleged that a Maltese entrepreneur had used his contacts with Mr Dalli to try to gain financial advantages from the company in return for seeking to influence a possible future legislative proposal on tobacco products, in particular on the EU export ban on snus . As soon as the Commission received the complaint it immediately requested OLAF to investigate.

The OLAF final report was sent to the Commission on 15 October. It found that the Maltese entrepreneur had approached the company using his contacts with Mr Dalli and sought to gain financial advantages in exchange for influence over a possible future legislative proposal on snus. No transaction was concluded between the company and the entrepreneur and no payment was made. The OLAF report did not find any conclusive evidence of the direct participation of Mr Dalli but did consider that he was aware of these events.”

Unfortunately, this is not the first time John Dalli has been accused of illegal and thoroughly unsavoury behaviour. Indeed, there is quite a back catalog, with ‘highlights’ including the following allegations:

The AMS Scandal

It is alleged that “he granted and paid Lm400,000 from the Malta Treasury so that the owners of this fictitious business could set up a factory in Malta, this never materialised and the person involved left Malta with the Lm400,000 (920,000 Euros approximately). Dalli was not held accountable for his misjudgement.”

The Water Miracle

During Dalli’s tenure as Minister of Economic Affairs from 1990-1992, it is alleged that Dalli’s “brother Bastjan (Sebastian) was accused of importing a container of approximately 730 boxes of whisky, gin, vodka and rum. Bastjan was accused of avoiding customs duty of Lm24,000 (55,900 Euros approximately). He stated that he had made an order for a container of bottled water but when it arrived it turned out to be a container of spirits. This came to be known as “The Water Miracle”, referring to Christ’s ability of turning water into wine. Again, Dalli was not held accountable for his brother’s involvement. The case against his brother is still pending to date (2008).”

The Mater Dei Hospital Scandals

It is further alleged that during Dalli’s tenure as Minister of Finance from 1992-1996, “the Mater Dei Hospital project was in full swing. This hospital project has been shrouded in political and financial scandals and proven incompetence. The Mater Dei is a six hundred-bed hospital which took more than 17 years to build at a cost of more than Lm250 million (582 million Euros)”.

“Many tenders were issued for this hospital. One major tender for the supply of concrete was awarded to Bastjan Dalli despite the fact that this was not the most competitive. Bastjan was also awarded many road-resurfacing tenders during this period despite his lack of knowledge in such projects. The auditing tender for the hospital went to an accountant’s practice with strong connections to John Dalli…. Many corruption allegations were made. Calls for an investigation were made but these were ignored and no one was held responsible for the alleged corrupt practices.”

The Daewoo Malta Ltd Scandal Part 1

John Dalli was elected and appointed Shadow Finance Minister in 1996. It is alleged that “[a]t the time Dalli was also a consultant for several large companies, one of them being Universal Commerce Agency Ltd. They were importers of motor vehicles such as, Daewoo, Holden, Dacia, Rocsta as well as other consumer white goods. While being a consultant for this company loans in excess of Lm16 million (approximately 37 million Euros) were granted by one of the major Maltese banks (Bank of Valletta) in which the Government had a majority share holding. These loans were granted with very little security and no questions asked. It was also alleged that as “Mr Fix It”, John Dalli received a backhander of more than Lm500,000 (1,200,000 Euros)”.

Is that hand reaching for the money?

The Mid Med Bank Privatisation Scandal

It is alleged that “[o]n the 14^th April 1999 John Dalli, Marin Hili and Joe N. Tabone sold Mid-Med Bank lock, stock and barrel for a pittance (Lm80 million approximately 184 million Euros). Hili and Tabone were close friends of Dalli and acting as alleged consultants on behalf of the nation. This National Asset was the largest bank in Malta that controlled more than half of the Maltese economy. … John Dalli sold this strategic national asset without having the consent of the Cabinet of Ministers. In fact even the Prime Minister of the time did not know about the sale because he was in hospital undergoing a heart bypass operation. John Dalli informed the Prime Minister of the sale when he was still convalescing. The opposition and other bodies made demands for an investigation. These were bluntly ignored.”

The Daewoo Malta Ltd Scandal Part 2

It is further alleged that “[s]oon after this scandal, rumours of serious irregularities at Universal Commerce Agency Ltd surfaced and were reported to the Prime Minister Dr. E. Fenech Adami and the Police Commissioner. They were informed that clients that bought vehicles were embezzled of more than Lm1.5 million (approximately 3.5 million Euros). To confirm this, the leader of the opposition (Dr. Alfred Sant) placed in parliament a detailed reconciliation that included the names, I.D. and account details of every client that was defrauded by Universal Commerce. This also included the monitory amounts that each client had lost. … Again the opposition demanded an investigation. The Government ignored these.”

Is Dalli his brother’s keeper?

It is further alleged that “[p]rior to being appointed Minister for Social Policy in March 1998, John Dalli’s brother Bastjan had been awarded a contract by the previous minister to build a block of flats in Floriana. On completion, the surveyors condemned the building due to bad workmanship and the wrong concrete mixture used between the floors. The building was not fit for human habitation because it was dangerous.

Social housing was in John Dalli’s portfolio and he was legally bound by law to start proceedings against his brother to recover the millions of Euros that this project had cost the taxpayer.

During the two years John Dalli was minister for social policy he failed to hold his brother accountable for negligence. Court proceedings were never started.”

All of the above allegations come from a blog post written by one Joseph Ellul-Grech, who appears to have pretty good reason to hold a grudge against John Dalli. I leave it to you to decide whether they are likely to be true, or merely the vengeful rantings of an annoyed citizen.

However, many other sources have also questioned the behaviour of John Dalli, and where there’s smoke… but let’s not get into THAT! (Well, not yet, anyway! )

Way back in June of 2011, Dick Puddlecote’s blog reported that John Dalli had told EurActiv that electronic cigarettes are more harmful than smoking tobacco! Then in March this year, Mr Puddlecote refers to Dalli as ‘The EU’s Maltese Muttonhead’, and says:

“It’s incredible that – despite the obscene amounts of money swilling around Brussels – no-one, it would seem, has tapped Dalli on the shoulder to whisper that he is talking demonstrable garbage about e-cigs.

Of course, it’s possible that they have done exactly that. In which case, it’s not just staggering that someone so mind-blowingly incompetent can be the Health Commission for around one billion of the Earth’s population, it is also unutterably terrifying!”

I couldn’t agree more!

On the subject of incompetence, how’s this for a spectacular example: In 2009, Bastjan Dalli, John’s brother, was charged with conspiring to deal in cannabis. According to the Times of Malta,  “[h]is arraignment follows that of another four men who were allegedly caught importing what they thought was cannabis but which eventually turned out to be soap.”

Soap??? Honestly, you couldn’t make this stuff up!

Perhaps Bastjan Dalli developed a penchant for soap during his time in the cells, having been refused bail after already fleeing Malta for Libya following his arrest. At his trial, according to MaltaToday he told the court that an unidentified man “had approached him while he was held at Corradino prisons earlier this year, and told him that he would be released if he admitted that his brother, former Minister John Dalli, was involved in the false report compiled by private investigator Joe Zahra.” (This report relates to the Mater Dei Hospital scandal above.)

This article goes on in rather a disturbing way:

“Bastjan Dalli stressed that he was quick to reply and tell the man that he had no intention of doing anything of the sort.

“When Bastjan was released on bail a few weeks later, he spoke to his brother John Dalli who in turn had told him that he would speak to the Police Commissioner about it.

“Dalli was not sure if his brother had in fact spoken to the Commissioner of Police. ‘I cannot trust anybody anymore, and this is why I didn’t say anything about this to anyone until now,’ Bastjan Dalli said.”

No wonder Bastjan feels he cannot trust his brother, since according to another article in the Times of Malta:

“In a statement released after the arraignment, Minister Dalli disassociated himself from the case against his brother.

“‘I learnt about the case from the newspapers a few days ago and immediately spoke to the Prime Minister who confirmed that I was not involved in any way,’ the minister said.”

Since John Dalli was so clearly only interested in keeping his own snout clean (and presumably ready for the trough), but very specifically without the benefit of any of Bastjan’s large quantity of soap, there is not much evidence there of filial support!

Not even all the soap above could clean this mess up!

Others, too, appear to have much to criticise in John Dalli’s behaviour. According to Daphne Caruana Galizia, writing in the Malta Independent on Sunday, in November 2011:

“If John Dalli thinks nothing of breaking the rules in the EU Commission’s book by conducting private business and negotiating sales to governments as the advisor to a technology company, then he would have thought nothing of, in his role as prime minister, buying for Malta a power station built and operated by a company that has or had him on board as a consultant.”

She goes on, almost as if she has witnessed his behaviour in the past…

“He can scream, shout, roll around on the floor, turn red in the face and even write to the Columnists Police to complain that he is put upon, but these are serious matters and the questions raised about them are more serious still.”

She then mentions both Dalli brothers’ apparent fondness for Libya, saying:

“The Gaddafi authorities must have thought that our set-up here in Malta was something like theirs. Nobody in Libya would have touched Bastjan Dalli because he is John Dalli’s brother. We know that was the way things worked there.

“A man with that kind of brass neck and inability to draw the line between public office and private business – or who thinks that drawing the line means leaving ‘John Dalli & Associates’ in the hands of his daughters while proceeding as normal – should never have been made EU Commissioner.”

I can’t help feeling that she doesn’t like him very much.

And now, the European Commission’s anti-fraud office, OLAF, has reported its findings, after a complaint was made to them by, of all people, a tobacco company, Swedish Match. From the Commission’s press release this afternoon:

Swedish Match “alleged that a Maltese entrepreneur had used his contacts with Mr Dalli to try to gain financial advantages from the company in return for seeking to influence a possible future legislative proposal on tobacco products, in particular on the EU export ban on snus.”

In their own press release today, Swedish Match made the following comments on the Commission’s press statement:

“Swedish Match takes this incident very seriously. The incident was promptly reported to the European Commission, and the report from the Anti-Fraud Office has confirmed that the notification was warranted and that a thorough investigation has been conducted.

“Swedish Match expects that the European Commission in the future will ensure a transparent and legally fair process for the proposal of a new Tobacco Products Directive which is expected during the autumn.

“Swedish Match expects that proven scientific facts regarding snus, including the well documented significantly lower health risks compared to cigarettes which are allowed in the EU, are considered in a continued fair legal process for the proposal of a new Tobacco Products Directive.”

What a headache this must have been for poor Jose Manuel Barroso, President of the European Commission.

Can anyone else see a figurative dart board out of shot here, perhaps with a photo of the doomed Commissioner’s face on it?

Because the undeniable reality of this whole sordid mess is that the Commission’s revisions to the Tobacco Products Directive have been utterly derailed. Indeed, the damage may even go far wider than just this, but surely at the very least, the Commission ought to scrap the existing consultation as entirely besmirched by these events, and start again, with the focus properly on public health and scientific evidence? One wonders how else they can possibly proceed, if they are to regain any of the credibility they have so publicly lost. If there were any doubt about this, Dalli himself confirmed the utter futility of the Commission’s attempting to pursue this consultation, in his own statement, published today:

“I will continue to work so that all efforts made by myself and my services to revise the Tobacco Directive will proceed as planned” (our emphasis).

Let us hope that in waving goodbye to John Dalli, we can also wave goodbye to the anti-public health agenda he was attempting to enforce.

Last week, there was much discussion across the vaping community and well beyond about the reported ‘leaked’ draft of the European Commission’s revisions to the Tobacco Products Directive. For anyone who missed it, it started with this article in the Tobacco Journal International. Oh, but don’t get excited. It’s behind a paywall, so you can’t read it unless you subscribe.

Our colleague James Dunworth, of Ashtray Blog fame (notoriety? ), went to the extent of subscribing, but apparently has not been able to read the article even then.

The ‘leak’ appeared in the German press, which was followed by Chris Snowdon’s blog (amongst other reportings), and then Professor Michael Siegel appeared to confirm that the ‘leak’ was genuine.

I don’t know whether the reported leak is actually representative of the European Commission’s position or not. Frankly, it seems a little unlikely, since it would take them several (long!) steps away from the scope of the Impact Assessment portion of their consultation process, which is the stage they are currently concluding. So in an effort to track down something a little more factual than assorted reports – however credible – of a leak, I wrote to the Commission last week, as follows:

21^st September 2012

Dear Dr Seychell,

Re: Revisions to the Tobacco Products Directive

It is with great alarm that we read reports of a ‘leak’ of your proposed revisions to the Tobacco Products Directive. It is being reported that the revised Directive will recommend a ban on all nicotine containing products unless ‘captured’ by tobacco regulations or medicinal regulations. It is reported that this will include electronic cigarettes.

I have explained before, but will reiterate again, that electronic cigarettes are not tobacco products, nor are they medicinal products. They have not been introduced to market by either the Tobacco Industry or the Pharmaceutical Industry, although both of these industries have been ‘buying in’ to the electronic cigarette industry.

Before leaving that point, it is necessary to stress once again that this need not change the product classification. The products from the electronic cigarette industry – whether brought to market by individual businesses from within that industry, or any other – are consumer products, robustly and well covered by existing consumer product regulations, full details of which we have already submitted for the Commission’s consideration.

It has been suggested that the Commission will recommend that electronic cigarette products should not be classified as tobacco products (a position we have already agreed with), but should be classified as medicinal products, and removed from the market until such time as they have a Marketing Authorisation from the relevant medicines regulator in each Member State.

Clearly, this would not be an appropriate suggestion (or Heaven forbid, Directive) from the Commission within the scope of the revisions to the Tobacco Products Directive, since it would need an entirely new consultation from the Commission to assess the question of whether or not electronic cigarettes should be classified as medicinal products.

Indeed, this question has been the subject of intense debate since electronic cigarettes first appeared in the global market in 2006/7. On several occasions now, this has been tested in various courts, and on every occasion, the rulings have indicated that the various legal definitions of a medicinal product in the different territories’ do not support the classification of electronic cigarettes as medicinal products, unless claims are made by the marketers that are deemed to be medicinal claims, such as ‘use this product to quit smoking’ and the like. (Indeed, when we met with the Commission, you agreed with us on this point.)

We stand ready to take the MHRA to court next Spring if they continue to try to misclassify electronic cigarettes as medicinal products, and we have every confidence that this would be successful. (We are working with other areas of the UK government, who seem to have a better understanding of the realities of this issue, and sincerely hope that Court action can be avoided.)

As we understand it, the Commission will now have completed the Impact Assessment for this consultation process. This will, no doubt, have indicated the significant economic growth of the electronic cigarette industry, and your own Eurobarometer survey clearly demonstrates how significant the positive impact on public health could be, if electronic cigarettes remain widely available to smokers. Equally, it is increasingly apparent that the risk of an explosive black market in electronic cigarette sales would be inevitable if their availability were to be restricted, which could only be utterly dangerous for the public. It is absolutely crucial that the proper regulatory standards are in place, but this cannot be achieved through medicinal regulation. The costs are too high, and the restrictions on the flexibility and appeal of the product are too great, so all the considerable public health benefit potential would be lost.

Yet there are so many millions of citizens who have successfully made the switch to using electronic cigarettes rather than smoking, and many of these citizens will want to continue to use these products even if they are illegal. Our concern in this regard is that this would remove the current quality and safety standards which are in place by virtue of the GPSR et al. These standards are essential in order to maximise the public health benefits. We do not want vapers to be forced into using potentially dangerous, unregulated products, of dubious origin.

Whilst we remain confident that the intentions of the Commission are genuinely concerned with achieving good public health outcomes, we would appreciate some assurance from you that the reported ‘leaked’ document has indeed been misrepresented. As more and more genuine research is carried out into the safety profile of electronic cigarettes (properly regulated under the GPSR et al), the more it becomes apparent that these products have the potential to dramatically influence public health outcomes positively.

It is our intention to publish this letter on our blog after 7 days have elapsed, unless there is a good reason for not doing so. This is so that the vaping community can be kept informed as to what ECITA is doing, since the reported ‘rumours’ and ‘leaks’ have been causing some distress, as I’m sure you can imagine.

I look forward to hearing from you at your earliest convenience.

Yours sincerely,

Katherine Devlin

President

ECITA (EU) Ltd

cc Dominik Schnichels

I am yet to receive a response, but will keep you informed if/when I do.

It was with a certain amount of irony that I received an email from a Charlie Thomas at the Huffington Post UK, during my extensive researches into responding to the various Lies, damned lies, and ‘science’ by press release of my previous blog. My response to Charlie’s email was, initially, a somewhat terse inclusion of his email address as a ‘CC’ to my covering email sending my letter to HuffPost Lifestyle, following their disgraceful copycat reporting of those lies.

To his credit, and somewhat to my shame, Charlie’s response was a polite note, explaining that he had not written that story, but was working on another one, for which he would value my input. I provided him with some information, but frankly, did not hold out much hope. It is fair to say that I am not alone – in our ever-growing community – in having had my faith in the press somewhat shaken in recent months!

However, this morning, Charlie’s article has been published, and looks like one of the better pieces of journalism about electronic cigarettes.

So, while I can’t quite go so far as to say that ‘Charlie is my darling’, I did want to publicly express my thanks and congratulations on a job well done. This is the closest thing we have seen for some time to proper journalism, where the journalist makes a concerted effort to do some meaningful research into the subject before rushing to print.

And while Charlie’s article does not serve as a retraction for the abomination published previously by one of his colleagues, it does at least refer to it, and goes some way towards setting the record straight.

Thank you, Charlie.