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October 21st, 2015:

Spotless leopards? Decoding hype on e-cigarettes

This is the full text of a paper I presented to the Oceania Tobacco Control Conference, Perth on October 21, 2015.

E-cigarettes are the latest innovation in nicotine delivery products to fly the harm-reduction flag. They follow the massive failures of cigarette filters. Over decades, filters falsely reassured millions of smokers that they were reducing their exposure to harm and so could keep smoking.

We also had the lights and milds fiasco – which saw 80% of Australian smokers select those misleadingly labelled brands, which the ACCC outlawed from 2005 as a consumer fraud.

Along the way we saw reduced carcinogen brands and even asbestos filtered cigarettes.

There was massive publicity about harm reduction from filters and low tar, and massive consumer uptake, but not a blip in the incidence of tobacco caused disease in those who still smoked.

Thanks to harm-reduction arguments, countless smokers continued smoking who might otherwise have quit. The tobacco industry drove these arguments and was supported by many in public health who innocently thought they were no-brainers. Nigel Gray, a giant of global tobacco control, later admitted that the decades-long, well-intentioned low-tar harm-reduction policy was a disaster.

Meanwhile, we continued with the core policies of trying to prevent uptake, encourage quit attempts and denormalise smoking via smoke-free policies to protect non-smokers. Together, these objectives have delivered Australia the lowest smoking prevalence in the world.

For 35 years since the early 1980s, we have seen continually falling incidence rates of tobacco-caused disease. Female lung cancer seems likely to never reach even half the peak we saw in males. Awkwardly for some, Australia has become a world leader in reducing smoking without any mass cessation clinic network or major embrace of e-cigarettes.

Today, demands are being made to rush in soft-touch regulation to allow e-cigarettes to be manufactured, flavoured, promoted and used virtually without restriction.

This is all being done on the shoulders of an argument that insists that after 50 years of tobacco control, there remain many smokers who can’t or don’t want to give up their nicotine dependence, and that in just a few years, sufficient evidence has already accumulated to show that e-cigarettes are both benign and great for cessation.

But the “can’t quit” argument has received remarkably little critical interrogation. We know that hundreds of millions of often heavily dependent smokers have quit since the early 1960s, most without any assistance at all.

We know that today’s smokers smoke fewer cigarettes per day than at any time in the past, exactly the opposite of what the hardening hypothesis would predict.

The demands of the “we don’t want to quit/we love nicotine” vaping activists for unregulated access to e-cigarettes and to use them without restrictions must be balanced against the risks of what these demands might mean for population-wide progress toward the goal of keeping smoking heading south.

Comprehensive tobacco control is not just about the preferences of vapers. It is most importantly about continuing to starve the tobacco industry of new recruits and ensure that smoking is made history.

If we think of e-cigarettes as a transformative genie in a bottle, we need to think very carefully before letting it out, because putting genies back in their bottles is much more difficult than impulsively letting them out. If they prove to be benevolent, all’s good. But if they bring false hopes and keep many people smoking, we may be looking at the early days of a third major false god of tobacco harm reduction.

That genie is well out of the bottle in England and the United States, and other countries need to watch what is happening there very closely.

Today, I want to examine four cornerstones of the public health case being megaphoned for e-cigarettes.

1. E-cigarettes are benign and the risks of nicotine are “like drinking coffee or something …”

No one sensible makes the argument that e-cigarettes are likely be even remotely as harmful as smoking.

The 2015 Public Health England report endorsed the “95% less harmful” than smoking estimate. They took this from a consensus report authored by 12 people. Six of these were subsequent signatories to the 53 signature letter to Dr Margaret Chan at the WHO calling for minimal regulation. Six had no research track record or experience in tobacco control whatsoever. Two had financial ties to the tobacco or e-cigarette industries (see here and here).

There is no transparency about how this group was selected. But this was plainly not a group which was ever likely produce a consensus that was anything but glowing about e-cigarettes.

But let’s assume they may have been in the risk comparison ballpark. If e-cigarettes are 5% as harmful, then we would only see 300,000 deaths a year globally from e-cigarettes, instead of six million if every smoker switched.

On present trends, (England’s Robert West suggests e-cigarette growth may have already plateaued in England) that scenario is as likely as pigs flying.

A far more likely scenario – as I will argue – is one that sees a continuing stream of smokers quitting mostly unaided as they always have; significant numbers attributing their quitting to e-cigarettes; but a slowing in overall quit attempts as many dual-using vaping smokers keep smoking at reduced rates, in the erroneous belief that they are reducing harm.

The quality of evidence we have for declaring e-cigarettes to be benign has been described in another review as very poor. A 2014 review concluded:

Due to many methodological problems, severe conflicts of interest, the relatively few and often small studies, the inconsistencies and contradictions in results, and the lack of long-term follow-up, no firm conclusions can be drawn on the safety of ECs [e-cigarettes]. However, they can hardly be considered harmless.

This review was not even referenced in the Public Health England review.

The health problems caused by tobacco develop over decades. Every year will bring us more and more information about what the consequences of the typical daily vaper inhaling nicotine, propylene glycol, and an unregulated cocktail of fine and ultra fine particles like flavouring agents approved for ingestion in foods but not for inhalation an average 120 times a day (43,800 times a year).

We will also see what the International Agency for Research in Cancer has to say about whether nicotine is carcinogenic, having declared in 2014 its assessment to be one of its priorities.

2. How good are e-cigarettes for smoking cessation?

Earlier this year, a paper co-authored by five of England’s best tobacco control researchers, including Robert West and Ann McNeill, reported the world’s first prospective cohort data on the question of quitting via vaping versus other methods.

Their data are of great importance because by distinguishing daily from non-daily vapers, they allow the differentiation of casual and experimental users from daily users. Their study also provides data on outcomes 12 months later.

The paper commenced by noting that:

Smoking prevalence in England has been declining from 20% in 2012 to 18.4% in 2014, and in 2014 smoking cessation rates were the highest since at least 2008. This simultaneous increase in e-cigarette use and cessation may be coincidental, and it is therefore vitally important for longitudinal studies to be conducted to assess the impact of e-cigarette usage on quitting behaviour.

So what did the study find?

Daily use of e-cigarettes while smoking appears to be associated with subsequent increases in rates of attempting to stop smoking and reducing smoking, but not with smoking cessation. Non-daily use of e-cigarettes while smoking does not appear to be associated with cessation attempts, cessation or reduced smoking.

A companion paper broke down the data further by type of e-cigarette product. Daily tank system users were the only group which showed a significant improvement in smoking cessation.

But of 1,643 smokers followed up at 12 months, only 69 – just 4.2% – were daily tank vapers at 12 months. And just over one in four of these – only nineteen or 1.2% of the total sample – had quit. This is hardly the stuff of revolutionary dreams for population-wide cessation!

In addition to the Ann McNeill-led studies I just mentioned, Robert West’s group’s Smoking Toolkit study has been monitoring tobacco use in England every month since 2007, including e-cigarettes since 2011.

While the McNeill group has reported that 2014 smoking cessation rates were the highest since at least 2008, the latest data from August in the Smoking Toolkit study show the lowest percentage of English smokers trying to quit since 2007 (31.6% down from a high of 42.5% in 2007).

These two data sets thus appear to show quite different, perhaps incompatible results about the proportion of smokers making cessation attempts and actual cessation. Greater clarity on this key issue is badly needed.

In August, the English Smoking Toolkit study reported that the large majority (over 80%) of e-cigarette users are dual users: they also continue to smoke.

Many vaping advocates downplay this gigantic elephant in the room with fingers-crossed optimism that dual use should always be seen as just a transitory phase that smokers go through before they quit smoking. As I will argue soon, the tobacco industry has other ideas about this.

So putting these studies together for England – “e-cigarette central” – where, in plain language, are we today?
• Non-daily vaping has no impact on cutting down or quitting.
• Daily vapers make more quit attempts than non-vaping smokers.
• But they don’t succeed any better than those who don’t vape.
• Daily tank vapers do better at quitting, but the numbers involved are very small.
• 80-90% of vapers are dual users.

And while this has been happening, the English Toolkit study reports that:
• Quit attempts among English smokers at large are at the lowest level since 2007.

3. Do vaping smokers cut back more than non-vaping smokers?

The Brose et al paper from England reported that at 12 months, 13.9% of daily e-cigarette users reduced cigarette smoking substantially.

But let’s turn the last figure around.

Even among those smokers who vaped daily, 86.1% did not even cut back smoking substantially. That’s how good e-cigarettes are at just reducing smoking. They are far less successful, for example, than workplace smoking bans, where we see 20% reductionsfrom reduced smoking opportunities.

I’m sure you’ll agree that all the Big Tobacco companies now selling both cigarettes and e-cigarettes must be simply mortified by this news.

But does reducing daily smoking substantially (>50%) reduce deaths from smoking caused disease?

Let’s suppose that most daily, sustained vapers did cut back substantially (which they don’t), would this be harm reducing?

We’ve known for decades that three synergistic variables (age of smoking onset, amount smoked and duration of smoking) are critical in predicting mortality from smoking. There is a dose-response relationship that no one disputes here: those who smoke more are more likely to die from their smoking than those who smoke less.

From this, it’s understandable that many smokers believe that, just as they know water to be wet, cutting down the number of cigarettes they smoke will reduce their harm.

But this is quite a different claim. The epidemiological data on lifetime risk is about total pack years and does not consider the question of whether the cumulative risks of smoking can be “reverse engineered” by reducing.

But there is large-scale research on this and it is not good news for the “cutting down obviously reduces risk” dogma. Four cohort studies published since 2006 have reported on whether reducing smoking, as opposed to stopping smoking altogether, confers any mortality benefit.

A Norwegian cohort of 51,210 people followed from the 1970s until 2003 found:

no evidence that smokers who cut down their daily cigarette consumption by >50% reduce their risk of premature death significantly.

A Scottish study of two cohorts followed from the 1970s to 2010 also found no evidence of reduced mortality in reducers, but clear evidence in quitters. It concluded that:

reducing cigarette consumption should not be promoted as a means of reducing mortality.

The largest study, from Korea involving nearly half a million men followed for 11 years, found no association between smoking reduction and all cancer risk but a significant decrease in risk of lung cancer, but with the size of risk reduction being “disproportionately smaller than expected”.

Vapers who keep on smoking – which is most of them – are fooling themselves if they think they are seriously reducing risk.

I now turn to the future of vaping. “Think of the children!” is a common sarcastic slur made daily by vaping activists across social media. These self-absorbed misanthropes, today’s WC Fields clones in their disdain for children, could not care less about the implications of e-cigarettes for teenagers.

All they care about is their unhindered access to unregulated vape gear and their rights to vape anywhere: in workplaces, next to you on planes, and presumably while driving the school bus, inside child care centres and hospitals.

They want access to flavours like Gummy Bear and Bubble Gum that would cause a riot at a three-year-old’s birthday party.

Vape is apparently so close to pure air that any restrictions are totally unwarranted.

In England, vaping by non-smoking kids is very uncommon. Nearly everyone thinks that is self-evidently a good thing.

But the same cannot be said about the United States where data from the US National Youth Tobacco Survey show that while cigarette smoking continues to fall ammong US teenagers, e-cigarette use has been dramatically increasing since 2011. It is now way ahead of cigarette smoking: there are now some 67% more middle and high school kids vaping than are smoking.

Apologists for teenage vaping actually try to argue that this is a good development! You see, all those teenage vapers would have been smoking were it not for e-cigarettes.

The small problem here is that this rise was not associated with a rise in dual or multiple tobacco or nicotine product use, and the decline in cigarette smoking had been falling before e-cigarettes arrived.

Some argue there is no problem in having tobacco- and nicotine-naïve youth taking up e-cigarettes and becoming addicted to nicotine.

Others would prefer authorities, such as the US Surgeon General and the International Agency for Research in Cancer, not vape shop owners and industry spin merchants, to assure us there’s nothing to worry about with such uptake. But as yet they have not.

Nearly all businesses survive and flourish by retaining existing customers and critically, stimulating new customers to start. If you sell tractors or sheep dip chemicals, you will have little expectation of finding new customers who don’t own sheep or land where a tractor might be needed.

But if you are selling products which have potential to be used by more than those already using them, you are vitally interested in non-users. Cigarette and e-cigarettes fit that description perfectly.

Leopards don’t change their spots. For decades the tobacco industry told us – and still does – that it is not the least bit interested in teenage smoking. If BAT succeeds in getting its hands on the Cancer Council Victoria’s teen smoking data, we all can be assured that it will keep the contents strictly within its opposition to plain packs division and never show the data to its salivating “capturing new smokers and vapers” divisions.

The global e-cigarette market today is a mixture of big tobacco-owned brands and those owned by start-up incumbents. The tobacco industry is rapidly acquiring those minnows it regards as likely to be most profitable and strategic.

Wide-eyed vaping advocates would have us seriously believe that the tobacco industry, with its billions of dollars in assets and long history of acquisitions, will not somehow soon swallow up most of these just as it did small tobacco companies all over the world.

No tobacco company currently acquiring e-cigarette brands is desisting in any way from attacking effective tobacco control. Plain packs are being attacked. Every day BAT bleats on Twitter about how high tobacco tax – the most important plank in comprehensive tobacco control – is causing more illicit trade.

The message is clear: taxes should be lowered, to make smoking more affordable and to arrest brutal falls in smoking.

Quite obviously, this is not an industry which wants smokers to stop smoking. It’s an industry with a business plan to have smokers keep smoking and to also vape when they can’t smoke.

It is an industry that understands how to erode the nicotine consumption “downtime” caused by smoke-free policies that have badly reduced sales. And guess what? This is exactly what most smokers who vape are doing.

The concept of e-cigarettes being a “gateway” into smoking has been rightly criticised as being an imprecise and vague, often being little more than crude “after therefore because of” reasoning.

But glib dismissals of the rapid rise of teenage use in “kids just try stuff” throw-away lines ignores the many appeals of vaping to teenagers and the fact that youth smoking is the lowest on record. Increasingly, most kids don’t “just try” smoking.

A very useful model of how e-cigarettes may work as a catalyst for smoking has recently been published. The authors provide a causal hypotheses for the initiation of e-cigarette use and for the potential transition to tobacco smoking that highlights the combined factors of:

• perceived negligible risk
• attractive taste options
• lower price
• inconspicuous use
• higher level of peer acceptance.

This model could stimulate important research into understanding e-cigarette uptake and any apparent transition to smoking.

We are well on track to see the end of the tobacco epidemic in this country. E-cigarettes may have a role in that. Time will tell. But there are major concerns about the core claims being made for e-cigarettes.

Australia should consider any policy changes in harm reduction very carefully. We should all be open to quality evidence that might suggest that this time we have something different. But equally, we do not want to repeat mistakes of the past.

Keep vaping China, don’t listen to the World Health Organization on e-cigarettes

When it comes to smoking and vaping, the world of public health seems more like Oceania, 1984, every day. In that Orwellian realm, Big Brother issued nonsense statements such as “war is peace, slavery is freedom, ignorance is strength.”

In the U.S., the CDC and the California Department of Health have assumed the role of Big Brother, effectively telling smokers they might as well keep puffing because ecigarettes are hardly any safer. Talk about an Orwellian inversion statement!

In truth, vaping is far less risky than smoking. E-cigarettes and other devices heat a nicotine solution to produce an inhalable vapor. They release none of the carcinogenic tar of cigarette smoke, making them the ideal nicotine-delivery system for smokers seeking to reduce or halt their intake of combusted tobacco products.

On a global scale, the World Health Organization is Big Brother. Dr. Margaret Chan, the WHO’s director-general, is a confirmed skeptic. As she told China Daily last week– “I recommend that national governments ban, or at least regulate, them,” she said. (Elsewhere, Dr. Chan has opined that e-cigarettes should be regulated the same way cigarettes are regulated– even though they are not remotely equivalent in terms of harm.)

Dr. Chan’s comments were contained in a news story on Beijing’s crackdown on indoor smoking which began on June 1st. The ban has reportedly boosted the public profile of ecigarettes.

As a result, the article said, vaping is becoming increasingly popular, particularly with young urbanites, according to Gan Quan, China director of the International Union against Tuberculosis and Lung Disease.

This is good news. As a just-published report in Lancet about the toll of smoking in China makes clear, switching from smoking to vaping for people who can’t quit on their own or via traditional means is a public health imperative. Researchers reported that two in three men there smoke (under four percent of women do). They estimate that smoking will cause about 20% of all adult male deaths in China during the 2010s. In raw numbers, the annual deaths in China caused by tobacco will rise from about 1 million in 2010 to 2 million in 2030 and 3 million in 2050, unless there is widespread cessation.

Beijing’s vaping trend is promising but country-wide, rapid transition from smoking to vaping is unlikely because smoking is deeply embedded in the culture. As a commenter in China Daily wrote: “Serving a cigarette is good manners. When we meet our boss, we serve a cigarette to him to show our respect. When we talk to somebody, we offer a cigarette as a peace offering, which will build trust observably. We thank our plumber with his fee and a cigarette, we serve a cigarette to a guest, suggesting ‘You are very welcome.’ A cigarette (a nice cigarette is better) is an external, material expression of a compliment. To our shy, not-good-with-words Chinese, cigarettes helps us talk.”

These facts show how nonsensical it is to consider a ban on e-cigarettes while failing to call for one on cigarettes. After all, cigarettes are 20-100 times more dangerous than

In fact, if China truly wants to be smoke-free, it is not clear why the government, which is not known to be shy about imposing paternalistic policies in other areas, does not simply ban cigarette production and let e-cigarette use bloom.

After all, e-cigarettes are a homegrown product, invented in China in 2003. Shenzhen province housed 900 manufacturers of the devices in 2013, up 200% from the previous year, and accounted for over 95% of global e-cigarette production. Yet, despite considerable progress in e-cigarette industry, China’s traditional cigarettes still dominate the Chinese market.

As Yanzhong Huang of the Council on Foreign Relations recently pointed out, “If only 1% of China’s smoking population turned to e-cigarettes, it would mean a market of about 3.5 million e-cigarette users.” The state-owned China National Tobacco Corporation, which sells almost all of the cigarettes consumed in the country, could become the world’s largest e-cigarette maker.

Right now, however, the Corporation is a massive income source for the nation. It generates CN¥816 billion (7-10% of GDP) in revenue. Indeed, tobacco receipts finance as much as half of some provincial governments’ budgets. The loss of so much income would make prohibition a huge challenge.

Another barrier is low public awareness. Only 25 percent of Chinese adults have a comprehensive understanding of the health risks of smoking, and less than a third are aware of the dangers of second-hand smoking, according to World Health Organization.

Less than 10 percent of Chinese smokers quit by choice and Chinese people are beginning to smoke at younger ages.

As for those Chinese smokers who do turn to vaping, China’s e-cigarette industry is currently very poorly regulated and the quality of vaping products is uneven. If ecigarettes are to replace traditional cigarettes and offset lost tobacco revenues, the government must regulate the industry more carefully to ensure safety and quality.

In the end, China is unlikely to ban cigarettes. At the very least, then, the environment should be made as friendly as possible for moving smokers to quality-made e-cigarettes.

Is there any hope for WHO on this issue? Dr. Chan has already received important information about the promise of electronic cigarettes. In spring 2014, 53 international health experts wrote a joint letter encouraging her to “resist the urge” to “control and suppress” electronic cigarettes by classifying them as equivalent to cigarettes for purposes of regulation. The letter was issued in the run up to the sixth Conference of the Parties, COP6, under the Framework Convention on Tobacco Control. The signatories advocated for tobacco harm reduction, or safer nicotine use in the form of vaping, to be considered by the parties.

In the fall of 2014, COP6 culminated in a decision to “prepare an expert report, with independent scientists and concerned regulators, for the seventh session of the Conference of the Parties. The report will include an update on the evidence of the health impacts of [electronic nicotine delivery systems], [their] potential role in quitting tobacco usage, [and their] impact on tobacco control efforts.”

This sounds promising – if the scientists involved are truly independent of a pre-existing animus against harm reduction. Geneva insiders, such as Dr. Delon Human of Switzerland-based Health Diplomats, anticipate that such an analysis won’t be available until the next COP meeting, probably slated for fall 2016.

One wants to be optimistic about COP7, but just in case, I hope many of the experts who penned the earlier letter to Dr. Chan, will write her again with a detailed, data-rich assessment of the virtues of tobacco harm reduction. If WHO is a responsible, evidence driven agency, it will quit the doublespeak on e-cigarettes.

All Party Parliamentary Group on Smoking and Health

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WHO REPORT On THE glObal TObaCCO EPidEmiC, 2015 – Raising taxes on tobacco

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WHO website downloadable reports on ‘tobacco taxation’

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Packaging and labelling of tobacco products

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Vaping might not help you quit

South Australian researchers have found e-cigarettes aren’t helping people to quit smoking.

Their study is small, just 87 people were surveyed. Researchers pulled data from Quitline callers over eight months.

They said they thought vaping would help them deal with cravings, and replace the hand-to-mouth action of smoking. But it’s not working – most of those who vaped, vaped every day, and also had a nicotine addiction.

The organisation’s Lauren Maksimovic said some people thought e-cigarettes were too similar to smoking.

“They were using that hand to mouth action, but it actually enhanced their smoking and it was just the same thing, they were continuing to smoke”

She says people were also worried about the unknown impacts of vaping on their health.

“We maintain serious concerns about the safety of e-cigarettes, particularly given that it delivers chemicals directly to the lungs.”

There’s mixed opinions on vaping – a peak health body in England has said e-cigarettes are about 95 percent less harmful than tobacco cigarettes. But the Australian Cancer council has long campaigned against them, saying there’s no evidence e-cigarettes are safe or that they help with quitting attempts.

Under Victorian poisons laws, e-cigarettes are banned if they have nicotine in them. Many e-cigarettes don’t have nicotine – and the Cancer Council found some people were using them in conjunction with other pharmacotherapies to help them quit.

In NSW e-cigarettes can’t be sold to people under 18. Lauren Maksimovic says they’re currently being aggressively marketed to young people through advertising, and their fruit flavours.

“We really want to raise the awareness that there’s not evidence out there at the moment that e-cigarettes are useful in quitting.”

Nicotine Increases Codeine Relief, Could Mean Risk of Addiction

Nicotine increases the amount of a specific enzyme in the brain that may increase the speed codeine is converted to morphine in the brain, according to research from the University of Toronto. The findings could implicate that smokers are at a higher risk for addiction to codeine.

Nicotine increases the amount of a specific enzyme in the brain that may increase the speed codeine is converted to morphine in the brain, according to research from the University of Toronto. The findings could implicate that smokers are at a higher risk for addiction to codeine.

Researchers, led by Rachel Tyndale, Ph.D., professor of pharmacology, toxicology, and psychiatry at the University of Toronto, administered codeine to rats in four groups and measured both their pain relief and levels of codeine and morphine.

The first group received nicotine for one week before receiving codeine; the second group was given an inhibitor, propranolol, which blocks the activation of codeine; the third group received both nicotine and the inhibitor, while a fourth control group was given neither.

The rats that received only nicotine had substantially more morphine in their brain and experienced greater pain relief, than those who also received the inhibitor. The group that was given propranolol and not nicotine had the lowest levels of pain relief and brain morphine. All of the groups maintained the same level of morphine in the blood, which showed it was change in the activity of the enzyme within the brain, not the liver that determined the effect of codeine on pain relief.

The biggest take away from the study, published earlier this year in Neuropsychopharmacology, “is there is genetic and environmental influences on the effects of drugs of abuse,” Tyndale, who is also senior scientists in the Campbell Family Mental Health Research Institute at the Centre for Addiction and Mental Health (CAMH), told Bioscience Technology. “In this case both those with faster activation of codeine to morphine, within the brain, due to genetics or due to induction of the enzyme, likely have better pain control, but also more risk for addiction to codeine. The latter group includes smokers. More generally it suggests that metabolism of drugs within the brain may alter the abuse potential for drugs.”

In the team’s preclinical mouse model, they showed that chronic nicotine increases the level of the enzyme in the brain which activates codeine to morphine. “We know this as we observe more of the enzyme in the brain in animals treated with nicotine, and in the brains of smokers in autopsy tissues,” Tyndale told Bioscience Technology. “When there is more of the enzyme in the brain, what we have shown is that codeine gets activated to nicotine more quickly and more extensively, increasing the pain relief from codeine by creating more morphine.”

This is a new way of looking at the brain’s role, as a more active participant, with codeine not just metabolized in the liver, but also in the brain itself.

“This is opening up a whole new area of research and potentially a substantial source of variation between people in their response to drugs and toxins acting on the brain,” Tyndale said. “We’re starting to see patterns and relationships, like the nicotine and codeine connection. This is also of interest in drug development as we might be able to create drugs that are only activated once they get to the brain.”

A limitation of the study is that it is a preclinical animal model. While the researchers know that the enzyme is higher in the brains of smokers, they still need to demonstrate that the brain enzyme is important to the effects of codeine in people.

Up next, the team plans to look at other opiates such as oxycodone, and hydrocodone, Tyndale said, “which are also metabolized by the same enzyme to determine what the effect of metabolism in the brain is for these other drugs.” They are also planning translational studies to take the work into humans.

Deeming regulations reach their final hurdle: the White House

Federal control has come a step closer for the U.S. e-cigarette market this week, with the Food and Drug Administration (FDA) sending its proposed deeming regulations to the White House office responsible for their final review.

On Monday, the FDA sent the regulations – which deem e-cigs to be tobacco products, and thereby bring them under the agency’s authority – to the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB) in the White House.

The OMB’s main role in the deeming regulations process is to ensure that they comply with overall federal policies set by the White House.

Its approval is the final step before the deeming regulations are published and become effective. It could send the regulations back to FDA for further revisions, but will likely approve them and allow them to move forward to publication.

There is no strict timetable for the OMB to comment, although it typically responds to agencies within 60 days.

However, its review could take weeks or months. During this time, the OIRA will consult with stakeholders to assess any unintended consequences that the regulations could have on the vapour industry.

They have been labelled as “economically significant” priorities, which “will be likely to have international trade and investment effects, or otherwise be of international interest”. Several industry groups have said that they will be in contact with the OIRA, including the Smoke Free Alternatives Trade Association (SFATA) and the Consumer Advocates for Smoke-Free Alternatives Association (CASAA).

These groups’ representations to the White House are likely to focus on widely-expressed concerns over the deeming regulations, including the cost of obtaining approval from the FDA for each e-cigarette product – reportedly estimated by the regulatory consultancy SciLucent at $2m-10m per item – and the lack of a meaningful “grandfathering” exemption for existing products.

It is not certain, however, exactly what the FDA has submitted to the OMB. The latest version of the deeming regulations could well differ from the text published for public comment last April, if the agency has decided to make changes based on that feedback.

The OMB previously reviewed the proposed rule before its publication last April by the FDA.

What This Means: The mere fact that the deeming regulations have moved to the OMB provides few clues as to the FDA’s final decisions on their content, although it certainly raises the possibility that no measures on child-proofing have been included, despite being called for by many in Washington and elsewhere.

After all, the FDA omitted those from the first published version, and a public consultation period on their inclusion only finished a few weeks ago: can there have been time for the agency to digest the comments and craft a policy accordingly?

In any case, what the progress of the regulations to the OMB surely does mean is that we can now expect their final publication in a few months at the most, unless – as seems unlikely – the OMB demands substantial changes.

Meanwhile, there may now also be renewed Congressional interest in the Cole bill that would provide a workable grandfathering date for e-cigs, allowing existing products to stay on the market without going through the full FDA approval procedure. That might be a bigger victory for the sector than anything else which could be achieved with the OMB.

– Carly Souther ECigIntelligence staff