Greg Hunt abandons plans to ban importation of devices after Coalition revolt

Posted May 20th, 2021 in News by Steve

Vapers in Australia will require a prescription for liquid nicotine but Greg Hunt has quietly abandoned a plan to ban the importation of vaping devices after a Coalition revolt.

On Monday, the Therapeutic Goods Administration gave its final decision requiring a prescription from 1 October, warning that e-cigarettes’ benefit as a quit aid must be weighed against harm to adolescents who may take up smoking.

In response, the health minister announced that proposed import restrictions that he was forced to delay in June “will not be proceeding due to the significant overlap with the TGA decision”.

The regulation proposed to ban both liquid nicotine and personal nicotine vaporisers, and tobacco industry sources believe that removing the import restriction will practically water down enforcement. The health department insists a process for Border Force to query the lawfulness of an import without a prescription is in place.

The Liberal senator, Hollie Hughes, said 28 Coalitions MPs and senators had signed a letter opposing the import restriction, and Hunt had now abandoned it.

“After the TGA and Hunt announcements, it’s clear they’ve listened, reversed position on the regulation, and that’s no longer on the table,” she told Guardian Australia. “We welcome that move.”

“We’ve gone from an attempt to restrict vaping to what is fundamentally the status quo [on personal importation] with a step to legalisation through a national prescription scheme.”

There are already bans in every state and territory except South Australia on personal possession or use of nicotine e-cigarettes and liquid nicotine without a prescription but the laws are little enforced.

In a statement, the TGA warned that “individuals attempting to import commercial quantities of nicotine e-cigarettes and liquid nicotine may be subject to importation and seizure of products and potential fines under existing regulation”.

The TGA’s public consultation received more than 2,000 public submissions, many from vapers concerned that requiring a prescription would reduce uptake of an option that minimises harm in comparison with combustible cigarettes.

The TGA delegate who approved the ban acknowledged “the personal experiences” shared in the consultation including “the successful use of nicotine e-cigarettes as an aid to quit smoking for these individuals”.

“However, while some individual smokers have successfully used nicotine e-cigarettes to quit smoking, evidence at a population level is lacking.”

The delegate expressed concern that adolescents are “vulnerable and particularly susceptible to nicotine addiction”, citing Irish Health Research Board reports that e-cigarette use makes them three to five times more at risk of smoking combustible cigarettes than those who have never used e-cigarettes.

The TGA decision also requires child-resistant closures for liquid nicotine to reduce the risk to children of accidental ingestion.

Hunt welcomed the TGA decision, which he noted was “independent of government” and “legally binding”.

He announced the government would allow Medicare refunds for doctors to use telehealth to prescribe vaping as a smoking cessation aid, to be available six months before the 1 October start date.

The government will also provide $1m for an education campaign focused on smoking cessation.

Internal critics of Hunt’s proposal, including Hughes and the National senator Matt Canavan, have warned that a prescription-only model is impractical, with just 14 of the 30,000 eligible GPs now prescribing e-cigarettes.

The pair’s open revolt has won favour in the Coalition party room, where 10 MPs and senators raised concern about the prescription-only model including the Liberals Trent Zimmerman, Tim Wilson and Eric Abetz and the Nationals Perrin Davey, Barnaby Joyce and George Christensen.

Earlier in December a Senate inquiry recommended that the government stay the course on the prescription-only model.

The Liberal senator Sarah Henderson combined with Labor and Centre Alliance to reiterate that e-cigarettes should be treated as a therapeutic good, rather than a consumer good sold over-the-counter.

Despite backing the prescription model as the “best pathway” to treat smokers, Henderson suggested in additional comments that the TGA “should consider reviewing the classification of liquid nicotine to enable it to be sold in pharmacies without a prescription” in future.

Greg Hunt digs in on opposition to e-cigarettes after vaping ‘epidemic’

Posted September 8th, 2019 in News by Steve

The health minister, Greg Hunt, has hardened his opposition to changing Australia’s e-cigarette laws amid warnings of a vaping epidemic that has led to at least one death in the United States.

But despite the government’s stance, the vaping industry, which includes big tobacco companies such as Philip Morris, is preparing to ramp up lobbying efforts to push Canberra for policy change.

Following pressure from Coalition MPs late last year, Hunt ordered an independent inquiry into the use of nicotine e-cigarettes, the first report from which will be delivered to government by the end of the month.

The public health assessment is being conducted by the National Centre for Epidemiology and Population Health at the Australian National University, with the study to look at electronic cigarette use in the Australian context.

The first stages of the research is investigating the “hardened smoker” hypothesis, which proposes that as smoking prevalence declines the remaining smokers will increasingly be “hard-core” or “hardened”, with higher nicotine dependence and less willingness to quit.

The hypothesis also proposes this group of smokers will be unresponsive to the traditional suite of tobacco control policies and motivational appeals.

A spokesman for Hunt said the minister was unmoved by those lobbying for Australia to change its approach to the regulation of vaping.

“The government’s position on e-cigarettes remains unchanged and the minister is firmly opposed to changing the current laws, particularly in light of recent statements by the US FDA about an epidemic of addiction among teen users.”

In Australia, the commercial sale of liquid nicotine used in vaping is banned, and can only be legally obtained with a doctor’s prescription.

A statement released by the US Food and Drug Administration and the Centre for Disease Control on Friday said that the agencies were investigating the link between e-cigarette use and severe respiratory disease, including a death in the state of Illinois.

As of 27 August 2019, 215 possible cases have been reported from 25 states, and additional reports of pulmonary illness are under investigation.

Despite unanimous opposition to vaping among the peak health groups, several Coalition MPs believe the government should support a regulated system, arguing it has benefits for hardcore smokers.

Liberal MP Trent Zimmerman said the FDA’s statement had not changed his views, saying he was still a supporter of a regulated system similar to that in the UK.

According to the federal government’s lobbyist register, several pro-vaping groups have engaged lobbying firms to help make their case to MPs, including tobacco giant Philip Morris.

Philip Morris engaged Capetal Advisory, which has links to the Labor party, in April.

Bradley Green, director of Capetal Advisory, told Guardian Australia that the agency had been engaged by Philip Morris “to assist on issues to do with alternatives to smoking”.

“There are still millions of Australians who smoke and how that is best addressed in the long-term is an interesting policy question that should be dealt with properly.”

Former journalist Michael Gleeson, who runs Beltway Government Relations, is lobbying for the Australian Vaping Advocacy Trade and Research Organisation, which has been established by a small Australian vaping company.

Prominent lobbying firm Barton Deakin was engaged in 2017 to promote a visit by Clive Bates, one of the most vocal campaigners for what some in the vaping industry call Tobacco Harm Reduction (THR).

San Francisco vape ban could hinder war on tobacco, say UK experts

Posted July 2nd, 2019 in News by Steve

San Francisco’s ban on sales of e-cigarettes could set back the war on smoking, according to public health experts in the UK who are doing everything they can to promote vaping as a way to quit.

As shopkeepers in San Francisco contemplate having to clear their shelves of vaping devices before the new year after a vote by city supervisors, many in the NHS are looking at ways to encourage more smokers to try them. This week in the north-east of England, an NHS taskforce urged doctors and nurses to talk to patients about smoking and reassure them vaping is safer.

The transatlantic divide over e-cigarettes is profound, rooted in social and ideological differences. San Francisco’s decision is directly in the tradition of Nancy Reagan’s admonition to young people offered drugs: “Just say no.” She first used the phrase in 1982 at a school in Oakland, across the bay from the city that is now saying no to vaping.

Public Health England has led the world in the opposite direction, backing harm reduction. An evidence review in 2015 concluded e-cigarettes were 95% less harmful than tobacco.

Martin Dockrell, the head of tobacco control at PHE, said there was a spectrum of opinion in the UK and US on e-cigarettes. San Francisco was very much “at one end of the spectrum – the abstinence-only, prohibition-style approach”, he said. While abstinence-only is the dominant view in tobacco control, “they also apply that to nicotine replacement therapy but also to e-cigarettes”.

There is huge concern in the US that young people who do not smoke will take up vaping. The Food and Drug Administration (FDA) and the federal government had recognised e-cigarettes could play an “off-ramp” role in helping smokers quit, but are concerned about the “on-ramp”, said Dockrell.

“In San Francisco, they have just abandoned any thought that e-cigarettes might be a significant off-ramp and they are only concerned about young people starting to use nicotine,” he said.

“Interestingly, they haven’t banned vaping cannabis. It’s still legal to vape cannabis and worse still, to smoke cannabis. It’s clear that the harm from smoking anything is much greater.

“Alcohol, smoked tobacco, cannabis, smoking or vaping – all of them are legal but the least harmful is e-cigarettes and they’ve banned them. Not just sales to young people, which we’ve done in this country, but for adults too. That is particularly difficult to understand.”

In February, PHE published an update of its evidence review which lamented the fact that only 4% of people trying to quit had used e-cigarettes.

Prof John Newton, its health improvement director, said: “We could accelerate the decline in smoking if more smokers switched completely to vaping.

“Recent new evidence clearly shows using an e-cigarette with stop smoking service support can double your chances of quitting.

“But with e-cigarettes currently used so rarely in services, it’s time for change. Every stop smoking service must start talking much more about the potential of vaping to help smokers quit.”

Across the Atlantic, there is great anxiety that non-smokers and particularly young people will take up vaping. There is concern that the flavourings could attract children and there has been a major outcry over the arrival of Juul, an attractively designed device resembling a USB stick that children have been using in schools. Juul was created in San Francisco and now has more than a 50% share of the US market.

The FDA has taken a tough line, mounting undercover operations and warning and fining retailers selling Juul and other devices to minors, as well as demanding Juul hand over documents on the science behind its devices and marketing strategy.

Speaking in April, Scott Gottlieb, the then FDA head, said: “In some cases, our kids are trying these products and liking them without even knowing they contain nicotine. And that’s a problem, because as we know, the nicotine in these products can rewire an adolescent’s brain, leading to years of addiction.

“For this reason, the FDA must – and will – move quickly to reverse these disturbing trends, and, in particular, address the surging youth uptake of Juul and other products.”

But in the UK, PHE says there is no evidence of a big surge in non-smoking young people vaping. Only 1.7% of under-18s use e-cigarettes weekly or more,a review in February found, and the vast majority of those also smoke. Among young people who have never smoked, only 0.2% use e-cigarettes regularly.

This month, a YouGov survey in England, Scotland and Wales published by Action on Smoking and Health found: “Young people vape mainly just to give it a try (52%) not because they think it looks cool (1%).”

Almost 77% of 11- to 18-year-olds had never tried it. Slightly fewer said they had tried vaping in 2019 than in the previous year (15.4% compared with 16%), although that was an increase from 12.7% in 2015.

A major driver of the hostility to vaping in the US is the involvement of tobacco companies. British American Tobacco, Altria (the parent company of Philip Morris), Imperial and Japan Tobacco have all diversified into e-cigarettes.

Anti-tobacco campaigners in the US spent decades fighting the wiles of the tobacco industry, gradually shutting down promotion of cigarettes and cementing the pariah status of the manufacturers. They refuse to believe e-cigarettes are anything more than a stalking horse to rehabilitate the industry.

Affordable vaping for smokers in poor countries branded ‘a human rights issue’

Posted November 28th, 2018 in News by Steve

The costs of vaping should be reduced for smokers in developing countries as an urgent “human rights issue”, researchers have told a pro-tobacco conference in London.

Addressing a 300-strong audience of tobacco and vaping industry representatives, Helen Redmond, an expert in substance use at New York University’s Silver School of Social Work, said people in poor countries should not be priced out of nicotine-based products that could potentially help them to quit smoking.

Redmond compared the medicinal qualities of nicotine with cannabis and stressed “the need to get vaping to the poorest, who need it most”.

“It’s a human rights issue – as a harm reduction device, prices need to come down,” she said. “Nicotine is not a dirty drug, it helps with depression and anxiety.”

Academics at the 2018 global tobacco and nicotine forum called for more research into the possible medical benefits of nicotine and a focus on the development of innovative nicotine-based products that will provide a “smoke-free society” and reduce the harmful effects of cigarettes.

Viscount Matt Ridley, an author and member of the House of Lords, joined the chorus of experts promoting vaping as a form of harm reduction, arguing that subjecting e-cigarettes to the same workplace restrictions as smoking could be viewed as an infringement of an individual’s human rights.

“We should treat vaping in the same way that we treat access to mobile phones,” said Ridley. “The best way to get people to give up [smoking] is to innovate with technology”.

Ridleytold the conference that, despite the industry’s continued focus on promoting nicotine-based products as a form of harm reduction, public opinion was moving away from vaping because of media “scare stories”. He compared the industry’s plight, in particular in the US, to that faced by “bootleggers and baptists during prohibition”.

Clive Bates, director of advocacy group Counterfactual, described the views of anti-tobacco campaigners as “hostile and focused”, accusing them of having rival commercial interests with a goal of “annihilating” the industry. Warning of the damage caused by “those with a vested interest in causing alarm”, he said that while critics laboured to produce evidence to “maintain the narrative of harm”, technological advances meant the transition to vape-type products was likely to become mandatory rather than voluntary.

There are 1.1 billion smokers worldwide and 6 million die each year as a direct result of smoking. A further 890,000 people a year die prematurely as a result of second-hand smoke, according to the World Health Organization.

A single cigarette contains more than 200 carcinogenic chemicals, as well as the addictive stimulant nicotine. Scientists and academics have so far failed to reach agreement on pros and cons of long-term nicotine use.

At a plenary session, clinical psychologist Karl Fagerström called for research into the positive benefits of nicotine, which he believes can aid people suffering from Alzheimer’s and depression. He also advised that the industry should move from combustible to nicotine-based products.

“No one is interested in establishing what the benefits of smoking nicotine are,” Fagerström said.

Martin Jarvis, professor of health psychology at University College London, saidthe US was moving towards prohibition-type enforcement, with the Food and Drug Administration eager to reduce the level of nicotine in cigarettes.

“Society doesn’t understand nicotine,” said Jarvis, “because they think it is particularly bad.”

But Jarvis said “describing nicotine as being addictive is justified”, adding that “80% of smokers wished they never started”.

E-cigarette science – is scaremongering hampering research opportunities?

Posted December 11th, 2017 in Uncategorized by Steve

Whenever I tell anyone I research e-cigarettes, they almost always have an opinion about them. Some will be vapers themselves, and those who are will almost without fail sing the praises of the device that finally helped them quit smoking. But often people who’ve never tried e-cigarettes will focus on the potential risks from using them, and in particular whether they’re likely to reintroduce smoking to a young generation who have been steadily shunning it in larger and larger numbers over recent decades. A particular fear is that young people will experiment with e-cigarettes and that this will be a gateway in to smoking, as well as fears around the harms from e-cigarettes themselves.

A recent detailed study of over 60,000 UK 11-16 year olds has found that young people who experiment with e-cigarettes are usually those who already smoke cigarettes, and even then experimentation mostly doesn’t translate to regular use. Not only that, but smoking rates among young people in the UK are still declining. Studies conducted to date investigating the gateway hypothesis that vaping leads to smoking have tended to look at whether having ever tried an e-cigarette predicts later smoking. But young people who experiment with e-cigarettes are going to be different from those who don’t in lots of other ways – maybe they’re just more keen to take risks, which would also increase the likelihood that they’d experiment with cigarettes too, regardless of whether they’d used e-cigarettes.

Although there are a small minority of young people who do begin to use e-cigarettes without previously being a smoker, as yet there’s little evidence that this then increases the risk of them becoming cigarette smokers. Add to this reports from Public Health England that have concluded e-cigarettes are 95% safer than smoking, and you might think that would be the end of the fear surrounding them.

But e-cigarettes have really divided the public health community, with researchers who have the common aim of reducing the levels of smoking and smoking-related harm suddenly finding themselves on opposite sides of the debate. This is concerning, and partly because in a relative dearth of research on the devices the same findings are being used by both sides to support and criticise e-cigarettes. And all this disagreement is playing out in the media, meaning an unclear picture of what we know (and don’t know) about e-cigarettes is being portrayed, with vapers feeling persecuted and people who have not yet tried to quit mistakenly believing that there’s no point in switching, as e-cigarettes might be just as harmful as smoking.

An unexpected consequence of this could be that it makes it harder to do the very research needed to elucidate longer-term effects of e-cigarettes. And this is something we’re experiencing as we try and recruit for our current study. We are conducting a research project funded by CRUK, where we’re collecting saliva samples from smokers, vapers and non-smokers. We’re looking at DNA methylation, a biological marker that influences gene expression. It’s been shown that smokers have a distinct methylation profile, in comparison to non-smokers, and it’s possible that these changes in methylation could be linked to the increased risk of harm from smoking – for example cancer risk. Even if the methylation changes don’t cause the increased risk, they could be a marker of it. We want to compare the patterns seen in smokers and non-smokers with those of e-cigarette users, potentially giving us some insight in to the long-term impact of vaping, without having to wait for time to elapse. Methylation changes happen relatively quickly as compared to the onset of chronic illnesses.

Part of the difficulty with this is that we know that smokers and ex-smokers have a distinct methylation pattern, and we don’t want this clouding any pattern from vaping, which means we need to recruit vapers who’ve never (or certainly only very rarely) smoked. And this is proving challenging for two reasons. Firstly, as borne out by the recent research, it’s very rare for people who’ve never smoked cigarettes to take up regular vaping. Yes, maybe they’ll experiment, but that doesn’t necessarily lead to an e-cigarette habit.

But on top of that, an unexpected problem has been the unwillingness of some in the vaping community to help us recruit. And they’re put off because of fears that whatever we find, the results will be used to paint a negative picture of vaping, and vapers, by people with an agenda to push. I don’t want to downplay the extreme helpfulness of plenty of people in the vaping community in helping us to recruit – thank you, you know who you are. But I was really disheartened to hear that for some, the misinformation and scaremongering around vaping has reached the point where they’re opting out of the research entirely. And after speaking to people directly about this, it’s hard to criticize their reasoning. We have also found that a number of e-cigarette retailers were resistant to putting up posters aiming to recruit people who’d never smoked, as they didn’t want to be seen to be promoting e-cigarette use in people who’d never smoked, which is again completely understandable and should be applauded.

What can we do about this? I hope that as more research is conducted, and we get clearer information on e-cigarettes ability to work as a smoking cessation tool, the disagreement around them will disappear. Until then, I hope that vapers continue to agree to take part in research so we can fully explore the potential of these devices, in particular those rare “unicorns” who vape but have never smoked, as they could be crucial to helping us understand the impact of vaping, as compared to smoking.