Wednesday, 12 June 2013

The MHRA Kills The Golden Goose

Proving yet again what is fast becoming a certainty of life along with death and taxes, the MHRA today finally concluded their deliberations on e-cigs by completely ignoring public responses to their {cough} public consultation.
All nicotine-containing products (NCPs), such as electronic cigarettes, are to be regulated as medicines in a move to make these products safer and more effective to reduce the harms of smoking
The UK Government has decided that the Medicines and Healthcare products Regulatory Agency (MHRA) will regulate all NCPs as medicines so that people using these products have the confidence that they are safe, are of the right quality and work
Smoking is the biggest single cause of avoidable death - killing 80,000 people in England each year. Making safe and effective products available for people who smoke can help them cut down or quit.
This is wordplay and sophistry of world class proportion.

The Guardian report that there are now around 1.3 million e-cig users in the UK, which makes it quite clear that e-cigs are an incredibly successful tool to "reduce the harms of smoking"; that 1.3 million people find that they "work" and "can help them cut down or quit".

The MHRA should know this from their own public consultation back in 2011 during which they received 1,217 responses from the general public. An overwhelming majority of these - if not all of them - were from satisfied e-cig users pleading for the MHRA to leave the devices alone and allow vapers to, indeed, "cut down or quit". On the other hand, they received just 9 responses from the usual bansturbatory elite demanding medicinal licensing.

In the face of such a landslide - and identical to the process employed for the EU's consultation on snus -  the MHRA chose to side with the 9 and toss out the views of 1,217 members of the public. Because, you see, the term 'public consultation' is a bit of a misnomer; the description they are seeking is more like 'organised fraud with a pretence of involving taxpayers and electors'.

The MHRA know very well that their proposals will do the exact opposite of helping smokers to "cut down or quit". They also know that medicinal regulation will make e-cigs considerably less "effective" by stifling innovation, raising prices and obliterating choice, thereby vandalising the very incentives for a product which has huge market support - and which has cost the taxpayer nothing. In short, they won't "work" any more.

Instead, what we are now promised is - be in no doubt about this - an effective ban on e-cigs in the UK, as explained by E-cig Politics.
I refer to pharmaceutical licensing as a ban, because it is. There are at least 5,000 products on the market now, the majority being refill variants. All will need to be removed from the market immediately licensing comes into force (within 21 days is the usual requirement). A license can only be applied to one product or product combination: a single hardware model, or a single liquid type/flavour, or a single device plus one liquid type. There is no possibility of a single license for several products. Each single product takes at least 3 years and at least £2m to achieve a license for (as that is what it has cost Intellicig in time and money to get their license so far, with no result as yet). Intellicig famously underestimated the cost and timescale, and have had to modify their time plan by a factor of 2 (initial estimate was 2 years), and their cost estimates by a factor of 20 (initial budget was £95,000). And it's not over yet. 
If either the EU or the MHRA achieve a ban via the pharmaceutical licensing or tobacco product classification routes, legal e-cigarette sales are finished in the UK, and a huge black market will ensue.
Quite.

But then it has all been so predictable, hasn't it? Once the revolution of e-cigs took hold, those who claim to be interested in health have clutched at multiple straws to deride, demonise, smear and undermine them.

We've seen attempts to invent passive and thirdhand vaping as a concept; heroic conspiracy theories claiming that millions of successful quitters are just an illusion; attempts to rig legislation at EU level; and junk science promoted as fact.

In the end, the pharma enthralled tobacco control industry have fallen back on justification so weak as to be laughable. That they vary in quality and that kids might use them.

ASH welcome regulation to stop kids using e-cigs despite their own study finding 0% of kids using them; the BBC seeks out a head teacher who banned e-cigs in their usual agitprop coverage, despite no student ever having been seen using one; and everyone else cites obscure and unrepresentative negative studies while ignoring the overwhelming benefits to health of over a million people cutting down on tobacco consumption.

It was all telegraphed beforehand too. With the MHRA abomination looming, state bodies redoubled their denialist efforts. The NHS Choices site - purporting to be a neutral fact-checker - displayed the underlying agenda perfectly by publishing this article yesterday.

Carefully cherry-picked junk science - and even this absurd Guardian article - were presented as proof that pharma produced NRT was absolutely brilliant, while e-cigs were dangerous and useless.

Written by someone who doesn't have much understanding of the devices (e.g. they all look like cigarettes; are triggered by air flow; batteries only last 2 to 5 hours), it contained 'neutral' info which clearly showed which side of the fence they were coming down on.
It’s not certain whether e-cigarettes deliver as much nicotine as forms of nicotine replacement therapy such as patches, so they may not be as effective at curbing nicotine cravings.
Hence why 1.3 million smokers have shunned e-cigs in favour of NRT with its 98.4% failure rate ... oh, hold on.
If you want to try a safer alternative to cigarettes but are concerned about the uncertainties surrounding e-cigarettes, you may wish to consider a nicotine inhalator.
A product which has been so successful that it hasn't attracted millions worldwide like, err, e-cigs despite being free and backed by saturation TV advertising.
Because e-cigarettes can be smoked in public places such as bars, restaurants and public transport, some people feel they may be normalising what has come to be seen as an unacceptable activity.
For 'some people', read 'a tiny minority of state-funded lobbyists and fake charities'.

And just in case you didn't get the message, they produce a neat infographic to make sure you make the, ahem, correct choice.


Today is the apex of tobacco control industry stupidity. Ultimate and resounding proof of what I have been saying for years. It has never, ever, been about health. And now they have illustrated it beyond reasonable doubt.

Anything that has gone before can now be disregarded, they have negligently provided all the evidence needed.

So they installed a smoking ban, so what? They have produced rules which could force 1.3 million vapers back to smoking. They banned vending machines. So what? They are effectively banning a revolutionary product which was reducing tobacco harm worldwide. They banned tobacco displays. So what? Their lapdog big pharma loyalty is the best thing tobacco manufacturers have heard for a long time. They intend to bring in evidence-free plain packaging. So what? They are also intending to obliterate a smoking alternative which carries global, real life evidence of overwhelming success.

It can never again be claimed that these people have any care for health. Ever. Just as we can now conclude with 100% confidence that public consultations are nothing but an elaborate and costly sham.

As one tobacco industry observer put it today, they have "killed the golden goose" before it's had a chance to lay many more priceless public health golden eggs. It was, as ex-Director of ASH Clive Bates dolorously described, "a good day for the cigarette makers".

But what does the tobacco control industry care? It was never about health anyway.



28 comments:

woodsy42 said...

This outcome was predictable from the BBC coverage yesterday, all about schoolkids (well 2) using them with 'child attractive' flavors.
But this makes me wonder - how will the effective ban work when the e-cig has no nicotine at all, as these flavours undoubtably were? Surely then it becomes just a flavour dispenser and nothing to do with smoking - and hence not subject to pharma approval?

Dick_Puddlecote said...

Ah, but that would fall into the trap of thinking that these people are logical or vaguely rational.


Even if there is no nicotine they will claim that it mimics smoking and should be banned anyway. Remember candy cigarettes?

Crossbow said...

If they had even the vaguest inkling of how e-cigs work, they probably wouldn't have gone down this road. But they don't, and nor apparently do they care. Even the science this is allegedly based on doesn't seem to support the decision... http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con288101.pdf

Dick_Puddlecote said...

Thanks for that, I'll read it at leisure later. Spelling mistakes on the contents page don't inspire confidence, though. #Incompetents

samuelmunro said...

hmm so the choice is either a product that works or something from the think tanks of Big Pharma that looks like a glorified Butt Plug.

westcoast2 said...

Oh well, back to the beginning, a PV and MYO. Of course, they will need to define an 'electronic cigarette' first. That may take sometime.


Maybe the MHRA are hoping the EU will do it. There does appear to be opposition at the EU level though and a mish mash of country regulations. The proposals do seem to presuppose the EU will regulate, this is not certain. Zero nic will be a problem for them.


Oh and will 'NCPs' include tomatoes?

What the.... said...

From the land of antismoking fanaticism/zealotry – New Zealand. The derangement of the extremism becomes more pronounced:

Embattled Palmerston North city councillor Bruce Wilson has been busy telling the world he is sorry for his comments about the possibility of sterilising Maori women as a means to reduce smoking.
http://www.stuff.co.nz/manawatu-standard/news/8517046/Saying-sorry-not-enough-Turia

Dick_Puddlecote said...

Even more ridiculous considering those obstacles. They're so intent on banning e-cigs for their pharma friends that they'll destroy their credibility on a wing and a prayer.


Health is the farthest thing from their minds. ;)

Dick_Puddlecote said...

Also relevant. Did you hear Sheila Duffy of ASH Scotland denying any knowledge of NRT being given to kids in response to Katherine Devlin on 5Live this morning?

Hey @ashscotland, here's one of the articles Sheila Duffy claimed she had no knowledge of on 5 Live this morning ow.ly/lWUQf— Dick Puddlecote (Dick_Puddlecote ) June 12, 2013



And here's another one @ashscotland ow.ly/lWUZ5 , how come she missed them? #SelectiveBlindness #IsItCosDeyIsPharma— Dick Puddlecote (@Dick_Puddlecote ) June 12, 2013

timbone said...

I smoke rollups at home, but when I go out, I take a pack of 'tailormade'. I tried ecigs a few years ago, but didn't get on with them. They have however been greatly improved, even available at my local Tescos, albeit on the pharmaceutical counter...a sign of things to come...which arrived in the news today.

Ironically, I had decided that when my 'tailormades' from Corfu ran out, (£3 a pack), I would get an ecig for when I was out. To be honest, I knew that this was going to happen sometime, although I did have a little dream that there were some sensible people out there who were not going to demolish a product which was already being enjoyed by well over a million people.

So, no ecigs soon, well, not legally, and when one eventually reappears, it will be the same price as 'tailormades'.

I have to say one thing against the ecig manufacturers. Saying in your adverts that ecigs help people to quit smoking was counterproductive. It always annoyed me. ecigs should always have been promoted as a safe alternative, not a means to stop enjoying nicotine. I am not saying that 'cuddling up to the enemy' would have stopped them from their ridiculous decision, but it may have made it more difficult.

westcoast2 said...

Amnesia, a worrying condition. Well spotted :)

Dick_Puddlecote said...

"it will be the same price as 'tailormades'"



Most probably more expensive, actually.


You have to remember that pharma NRT is partly useless simply because it isn't sufficiently cheaper than smoking, and regulation must have a bearing on that.


So now e-cigs are successful, pretend health advocates are trying to level the playing field for their chums by inflating the price of e-cigs too.


Great, so they'll keep their sponsorship contracts for future anti-smoking conferences, but will force vapers back to smoking in the process. I'm pretty thrilled they have finally admitted that I've been right all along, I have to say. :)


As for the methods of some e-cig afficionados, I agree. Not just advertisers either, strutting round the EU calling tobacco companies 'Big Death' was pretty naive as well.

woodsy42 said...

I assume you are right and they will aim at the 'looks like smoking' target but I will be interested to see how they distinguish between a non-nicotine e-cig and a plain vaporiser.

And yes I do remember candy cigarettes - you mean like these? http://www.amazon.com/dp/B001BU0JEK. For every ban there is someone who gets around it.

emma2000 said...

If they are classed as a medicine will we get them free on prescription?

What the.... said...

If I may make a few observations.

This clamping of e-cigs was predicted a few years ago. In some countries, e.g., Australia, they are effectively banned. E-cigs pose a threat to the “established order” which Gigantic Pharma dominates. GP spent billions cultivating the market for its useless/dangerous wares by funding a variety of activist groups to push for the “denormalization” of tobacco smoke/smoking/smokers, e.g., extortionate taxes, the “incredible” risks of smoking, smoking bans galore – inside and out, employment bans. Put the squeeze on smokers to quit – that they MUST quit – and a variety of groups and medical organizations will direct them to Pharma wares. GP is now eyeing off the very large markets of China and Russia where, if antismoking is allowed to flourish, provides the opportunity for many billions of dollars.

GP doesn’t take prisoners. It’s a ruthless industry. Under its domination much of the human condition has been “medicalized”, usually requiring pharmaceutical remediation, i.e., PROFIT. If it takes making neurotics, hypochondriacs, bigots of the masses to peddle its wares, so be it.
And society has sat back and accepted the highly consequential assault.

E-cigs were always up against it. Manufacturers/sellers didn’t spend a cent on the vulgar “cultivation of the market” but fully expected to reap the rewards. Utter fools. Unfortunately, there are also e-cig manufacturers attempting to exploit the antismoking hysteria for profit alone, playing very much on “nicotine addiction” and many other antismoking slogans.

There’s a very peculiar mindset for many vapers. They seem
to have swallowed the antismoking rhetoric and, as vapers, don’t see themselves as those “filthy, disgusting” smokers any longer. For many, e-cigs have provided a way of avoiding the denormalization “heat”, of jumping ship when the going got a little tough. They have effectively become antismokers. And this “new breed” boasts an increasing group of vapers. Who can stop this advance? Well, vapers still only constitute a small percentage of smokers. And we know what happened to smokers - a much, much larger group. The medical racket has no problem even attempting to denormalize smoking in countries where smokers are
40%, 50% of the adult population. And here are these vapers declaring that they are a growing, albeit very small, group that has to be reckoned with….. that they’re going to make waves. Who do they think they’re kidding? Do they really think that denormalizing e-cigs is any more difficult than smoking when facts play very little part in the proceedings?

Also, the vapers have noticed that the medical racket shamelessly lies towards its own ends. But they think the lies only pertain to e-cigs. They
seem to believe that everything claimed about active smoking and secondhand smoke is absolutely correct and that, suddenly poof, the medical racket only started lying when it came to e-cigs. Very foolish. Vapers seem to believe that smoking “causes” all sorts of diseases, a claim with little/no basis that was also being made 150 years ago. There are certain risks associated with smoking but they are nothing as they are depicted by the medical racket. Many smokers are convinced that they will die a slow, painful death (and at any moment, at any age) whereas
nonsmokers dying, even of the same diseases, have wonderful, dignified,
painless deaths. We don’t seem to recognize inflammatory propaganda at all. Unfortunately, this is what happens with the constant play on the primal fear of disease and death. There’s much easy loot to be made exploiting this primal fear/terror, and the medical racket has gotten very good at it. Furthermore, it’s nothing new.

What the.... said...

If someone said that they were getting on in age and that
the physical system wasn’t dealing with smoking (and other things) like it used to, there’s no problem. Fair enough. It covers even psychogenic issues, i.e., anxiety produced by propaganda. Such people might quit outright or even go to e-cigs. Before the current antismoking crusade took hold there were many people who quit smoking. They didn’t become rabid antismokers. They would sit with
people smoking without a problem. They simply didn’t smoke. Some would say that they wished they could still have a puff, but it wasn’t for them any longer. In this sense, smokers, ex-smokers, and vapers could have maintained a “united front” against the raving extremists, the dangerous partnering of zealotry and vested financial interests. But not so. The problem now is that we have
ex-smokers that deteriorate to rabid antismoking, including vapers. They have quit smoking by training themselves to hate it. That’s not a good mental state. These are the people that are now “hyper-sensitive” to smoke; that they can smell the “disgusting” smoke on people at 50 yards.

Consider this oaf.

John Mackley quit smoking cold turkey about two months ago. Paying for gas and staring at a wall of cigarettes behind the counter, he still gets cravings. The former road construction flagman snuffs them out with Lifesavers.
His strategy for stamping out temptation and other cigarette-related ills includes an additional tactic: banning smoking at Two West Penn, a Carlisle public housing complex for seniors.

http://www.pennlive.com/midstate/index.ssf/2012/09/cumberland_county_public_housi.html

So, Mackley has quit smoking and now he wants everyone around him to fall into line with baseless bans inflicted, in this case, on the elderly…. to reduce temptation for him. It’s cowardly, it’s bigoted. Welcome to the times!

Rursus said...

We must remember this:

The Food and Drug Administration (FDA - The "american MRHA") classified electronic cigarettes as drug delivery devices and subject to regulation under the Food, Drug, and Cosmetic Act (FDCA) prior to importation to and sale in the United States. The classification was challenged in court, and overruled in January 2010 by Federal District Court Judge Richard J. Leon, citing that "the devices should be regulated as tobacco products rather than drug or medical products."[1]

Judge Leon ordered the FDA to stop blocking the importation of electronic cigarettes from China and indicated that the devices should be regulated as tobacco products rather than drug or medical devices.[2]

US and UK respective laws concerning "medicine" are almost identical since the thalidomide/contergan scandal in the beginning of the 60's.

These "facts" of MRHA, which we have plucked out of thin air, will fail when it's going to court. Only one company is needed to take this directly to judicial bodies - We'll see! :)

But: Haste is necessary!

[1] http://www.aafp.org/online/en/home/publications/news-now/health-of-the-public/20100302e-cig-fda.html
[2] http://www.nytimes.com/2010/01/15/business/15smoke.html

SteveW said...

Add to that, Rursus, the recent decision in the TARTU Administrative Court of Estonia and it appears to be something of a busted flush before they even start...

http://www.ecita.org.uk/kohtuotsus_e-sigaretid_zandera%20vs%20ravimiamet_ha-3-12-2345_07032013_en-us.pdf

Sam Duncan said...

Is that graphic meant to put us off e-cigs? They're unlicenced, untouched by the National Health Soviet, and give a quick hit of a non-standard dose. They sound awesome. No wonder the bastards can't stand them.

Shadow Guest said...

O/T
Let me introduce to another nut case that’s been unleashed by TC and Public Health. This concerns a smoking ban at addiction recovery centers. It concerns people presenting for serious, impairing addictions, e.g.,
narcotics, alcohol, that have consequences in the immediate term. It’s also
known that people that don’t want to quit smoking, which is not an
immediate-term issue, put off seeking treatment for serious addiction when
smoking bans are instituted. So why would anyone….. let me qualify that…. why would anyone in their right mind institute smoking bans? Unfortunately, there are some that don’t want to quit smoking that, for whatever reasons, find themselves in one of these facilities.

Treatment for nicotine sobriety
Loebs explained that Seabrook treats two kinds of people around the issue of nicotine:
Those who want to quit and stay quit
Those who don’t want to quit
How do they treat these two groups differently? “Not at all,” she says. “Both
groups receive nicotine replacement therapy if they choose that, lozenges, hard candies, and they are all required to attend Nicotine Anonymous 12-step meetings.”
She explained that those in violation of the tobacco-free policy by verbalizing cravings constantly or acting out must attend a nicotine recovery program. This group then takes the place of their daily gym time.
“We see that as an incentive,” Loebs commented. “We try not to shame them and try to help them, but we want to be clear that we have a zero tolerance policy.”
“Programs that have been successful at this, have all said the same thing, ‘it is as dangerous and as important as alcohol or opiates or any other
substance.’

http://www.behavioral.net/article/replacing-cigarette-butts-candy-wrappers

I’ve got to tell you, this has to be right up there for pure stupidity, ignorance,
and haughtiness. NICOTINE SOBRIETY!! Have you got that – NICOTINE SOBRIETY!!! Sobriety as opposed to what? And they’re all required to attend “Nicotine Anonymous 12-step meetings”. A Nicotine Anonymous 12-step program!!!!! And a “nicotine recovery program”!!!! AAAHHHHHHHHH!!!!!

Just when you think we’ve hit the bottom of the perversity barrel….
BAMM KAPOOK…. the fanatics/zealots find a new bottom, a new sludge level. The insanity just gets deeper and deeper. It’s scary that this sort of sanctimonious, obnoxious nitwit, making up all sorts of obsessed-with-control blather that all must strictly abide by, is in charge of anything, let alone an addiction treatment facility. I wouldn’t put this fool in charge of a broom closet. The woman herself is in urgent need of psychotherapy or maybe a stint in a correctional facility for abuse of patients. It’s bad enough to ban smoking as a coercive measure. Filling people’s minds by force with condescending, bigoted drivel is more than a few steps too far. And this nut case has been set loose to explore the bounds of derangement, to be inflicted on others, by TC and PH. I repeat. TC/PH folk are dangerously disordered minds.


See also comments on Siegel's current thread.

jaycas said...

Yep, it's all just to do with control of nicotine delivery, a turf war between Big Pharma v Others

John Gray said...

For some reason or other I am not sure that this will be such a cakewalk for tobacco control as some people seem to think. I don't know why - it's instinct and being in anti-prohibition for ten years. It doesn't have quite the feel of success for TC I have been used to in the past.

Moreover, many will recall that a favourite mantra of TC is that you cannot stop an idea whose time has come. I think this applies to e-cigs. They are a brilliant invention (even though there is still much room for improvement).

Of course, having said all that, I may still turn out to be wrong - but equally, I am extremely optimistic that on this occasion I am right!

Dick_Puddlecote said...

The only people who don't think e-cigs are brilliant are the exact people who have been banging on about smokers quitting for decades. They've revealed their full hand with this and shown they were bluffing with just a pair of twos all along.


I agree with you entirely. The tobacco control industry are used to bullying smokers who have self-censored because many of them have been conditioned to feel guilty.


Vapers are a different beast and will fight them hard to the bitter end. It's going to run and run, and I don't think tobacco controllers are going to come out the other side with any credibility whatsoever. First impressions I get from my anti-smoking employees is astonishment, it's been great fun as they start to realise that my assertion that "it's not been about health" is being proven dramatically correct. :)

Dick_Puddlecote said...

But the bastards are 1) talking to other bastards, and 2) think that smokers are somehow scared of risk.


Erm, smokers are the very essence of risk-taking individuals! Only those in their late 60s would have started before the risks were known, why would they be worried about phantom risks from e-cigs?


Daft.

SadButMadLad said...

I particularly liked the head teacher that banned e-cigs. I presume he also bans real cigs. And does that make the slightest bit of difference in the actions of the kids? Not a jot. And if he thinks it does then he doesn't deserve to be a head teacher as he doesn't know how kids think, so how the hell can he teach them.

PT said...

You won't unless someone gives you a copy. That PDF has disappeared from the site and amazingly doesn't even seem to be in Google's cache.

Rob said...

We HAVE to get out there and we HAVE to get visibility, ecigs (most of them) work and it actually becomes almost embarrassingly easy to quit smoking, I had tried everything before from acupuncture to hypnosis, with little success. We need a day organised where we can congregate in numbers all over the UK and get the media involved. As it is we are not visible at all, that is the key to this. We are over a million strong in the UK now, we should have a lot of clout. We dont have a lot of clout BECAUSE WE ARE NOT VISIBLE.

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