HOLLAND, Professor Anne, Board Director, Clinical Care and Resources, Thoracic Society of Australia and New Zealand

THOMPSON, Professor Bruce, Treasurer and Board Director, Finance, Risk and Audit Compliance, Thoracic Society of Australia and New Zealand

Committee met at 09:29

CHAIR ( Mr Zimmerman ): I declare open this public hearing of the Senate Standing Committee on Health, Aged Care and Sport in reference to the inquiry into the use and marketing of electronic cigarettes and personal vaporisers. I would like to thank you all for your attendance this morning. Before we begin, I ask a member to move that the media be allowed to film the proceedings today in accordance with the rules set down for committees.

Mr ZAPPIA: So moved.

CHAIR: I declare that carried. We're starting this morning with representatives from the Thoracic Society of Australia and New Zealand. If they happen to be here, do you have any objection to being recorded by the media today?

Prof. Thompson : No.

CHAIR: I just need to remind you that these hearings are formal proceedings of the parliament. The giving of false or misleading evidence is a serious matter and may be regarded as a contempt of the parliament. The evidence given today will be recorded by Hansard and attracts parliamentary privilege. Thank you for your written submission, which we have before us. Before we move to questions, I wanted to see whether you would like to make an opening statement?

Prof. Holland : The TSANZ is the peak body for respiratory health professionals and researchers. Our submission was developed in partnership with Lung Foundation Australia and also reflects their views. They send their apologies today, as they are unable to be here. To begin, TSANZ notes and objects in the strongest terms to the involvement of the tobacco industry in these proceedings. We have previously written to the committee about our concerns. TSANZ, as a matter of policy, does not meet with or engage in discussions with the tobacco industry. Their primary purpose is to make profit for shareholders through the sale of tobacco products. That they are diversifying into e-cigarettes does not exclude the commercial interests in these proceedings. TSANZ respectfully advises the committee that, due to the industry presence creating a conflict for us, we will be leaving after the break.

Prof. Thompson : As a respiratory health organisation, we are very committed to seeing people quit smoking. We think it is important to state that if the evidence was strong that electronic cigarettes did achieve high smoking cessation rates without undermining tobacco control successes in this country, then the TSANZ will consider their use in smoking cessation. However, there is no strong evidence that electronic cigarettes promote smoking cessation and they do not contribute to a smoke-free society. Chronic respiratory conditions can take many years to become symptomatic. It is therefore important studies the track health impacts over the long term, by which we mean greater than 10 years. The TSANZ considers there to be significant need to support ongoing research in this area and we note that some funding has a ready been provided by the NHMRC project grant scheme. However, we would advise caution with respect the idea that electronic cigarettes promote smoking cessation. They may actually do so; the problem is we just don't know. Equally, they may also severely undermine the tobacco control agenda that is already in place.

There are numerous studies demonstrating significant dual use, and this committee has heard that the majority of e-cigarette users are smokers. Dual users can, of course, continue to smoke. When they find themselves in an environment where they can't smoke, rather than being encouraged to quit, they simply just use an electric device. Electronic cigarettes have the potential to renormalise smoking and to introduce a new socially acceptable activity which would significantly undermined the successes of the tobacco control policies which restrict smoking and encourage cessation. We may well find that it may well function as a continuation device rather than a cessation device. We simply do not know enough to make an informed decision about how these devices function socially.

In addition, we are extremely concerned when we see studies citing increased smoking uptake amongst children who use electronic cigarettes. Where there is a risk of renormalising smoking or e-cigarettes becoming socially acceptable among smokers, then we must object to their use at all costs. The reason being we know that electronic cigarettes cause significant damage to the lung. If there is a role for these devices to be used by current smokers, then this requires further research and regulation by the Therapeutic Goods Administration as a therapeutic device. This is especially important given the potential toxicity of excipients in electronic cigarettes. This is a sensible harm-reduction approach as it targets only those individuals who require harm reduction.

However, there are concerns about emerging studies demonstrating an increase potential for harm, especially in cardiovascular health, and that e-cigarette use may lead to increased e-cigarette consumption. Making these products freely available as a consumer good, when it is a product that causes damage to the lung, is not harm reduction. Indeed, it is indeed harm escalation. Study after study demonstrates that these products lead to adverse physiological and histological changes within the lung. In our submission we outline these studies, several of them from Australia.

We are not able to support the ready availability of a product that causes adverse effects in the lungs. It is not just the nicotine doing damage; the additives are also problematic. The marketing of these products, coupled with the use of flavourings designed to appeal to young people and children—for example, banana split, gummy bears and fruit loops—means that children are being targeted as potential users of electronic cigarettes. As the current literature suggests that children have an increased risk to go on and transition to traditional cigarettes, this is totally unacceptable and can hardly be seen as a positive harm-reduction argument.

Australia currently enjoys a very low smoking rate amongst young people. We must not jeopardise this by allowing electronic cigarettes to enter the market as a consumer product. We do know that some of the flavours which may be fine to ingest are very toxic to the lung when superheated and inhaled. We need to ensure these products are not readily available to children and nonsmokers as we know chronic obstructive pulmonary disease, or COPD, along with other chronic respiratory conditions, is caused not only by smoking but also by the inhalation of irritants similar to those that are found in electronic cigarettes. There is evidence that electronic cigarette particles have a similar adverse role to play in the development of COPD. The burden of COPD in this country is already far too high. It is one of our top five killers and creates a massive economic burden not only on the health system but more broadly.

We have just returned from the European Respiratory Society International Congress and we can most assuredly advise the committee that Australia is not out of step with the rest of the world with respect to our significant well-substantiated concerns regarding electronic cigarettes. We urge the committee to utilise our existing sound systems for regulation through the Therapeutic Goods Administration and to adopt the precautionary principle in their deliberations.

We cannot repeat the mistakes made with cigarettes. We cannot let the tobacco industry and their supporters tell us otherwise. The TSANZ recommends electronic cigarettes should not be a consumer product and we urge you to consider regulation and research into this product to see if it is safe or has any therapeutic benefit to the Australian community. The TSANZ strongly believes that there is significant potential for societal harm from supporting electronic cigarettes and that this far outweighs the unproven potential for any individual benefit from the use of these products to aid smoking cessation. Thank you.

CHAIR: Thank you. Professor Holland, did you want to add anything to that?

Prof. Holland : No, I'm happy.

CHAIR: Thank you for being here this morning. I might kick off the questioning. There are obviously several streams of argument in relation to this issue. One is the gateway argument. Another is obviously whether there is a lesser health impact in using e-cigarettes. Third is its role as a cessation device. The committee has scores of individual submissions from people who have indicated that it was the breakthrough for them ceasing smoking, but I grant you that that is hearsay evidence.

I want to go to the harm issue. In your submission you state that e-cigarettes may do less harm than tobacco cigarettes. We've heard other evidence that they do 95 per cent less harm than smoking a cigarette. Isn't it likely that e-cigarettes do some degree less harm than smoking a cigarette?

Prof. Thompson : I've been thinking about this a lot, understandably. What I find curious is that cigarettes kill people. That's it. If that's your baseline then that's a really interesting baseline to work from. You're basically saying, 'Okay, we're not going to kill you, but we're going to do significant harm to you instead.' I have a problem with that.

CHAIR: The converse is to say that e-cigarettes will save lives that otherwise would be lost because of cigarettes.

Prof. Thompson : Absolutely, but they're going to be harmed and crippled with respiratory conditions, sitting on oxygen and in beds all the time.

Prof. Holland : We know the effects on the cells in the lung are not good. We've seen decreases in immune function in the cells in the lungs related to e-cigarettes. What we don't know is how this plays out over the lifetime of the person. We know that respiratory conditions take many years to appear but, once they do, the damage is done and there's nothing you can do about them. If these are going to play out into longtime respiratory conditions then we are going to see disability and health system costs associated with that in the long term. We need to have that information before we can decide—

CHAIR: But the question, I suppose, is whether the mortality rate from using an e-cigarette versus a cigarette is going to be less.

Prof. Holland : We don't know that, and I would say that for respiratory conditions you have to think about the morbidity as much as the mortality. These conditions really disable people. They make them very high users of health services. They mean that they can't participate in society. Those people stop work earlier than others. So it's not just about killing people; it's all those other morbidity effects that we need to consider. We don't know the answer to that yet and we need to know.

Prof. Thompson : That's based on studies that are looking at individual components. As it's totally unregulated, we don't know what's in it. There are a thousand flavours at the moment—

CHAIR: That could be an argument for regulation, where you've basically got these products readily available as your submission says.

Prof. Thompson : To put a drug on the market to be used, you need to approve toxicology. I'm working through this with an inhaled antibiotic at the moment. I have to do toxicology on that one single compound. And that's a perfectly fine process. It works beautifully. If they did all that and then demonstrated that in fact survival was better if you smoked one of these—if they did all that work, which would take 15 or 20 years—then we would obviously look at it favourably.

CHAIR: We faced a similar problem with medicinal cannabis and cut the process. TGA has not gone through a 20-year process with medicinal cannabis.

Prof. Thompson : Exactly. I published the first paper on marijuana smoking on the lung, and it destroys the lung.

CHAIR: But medicinal cannabis is somewhat different from a joint.

Prof. Thompson : True.

Prof. Holland : I think that, if we're talking about this as a harm-reduction strategy, we would say we're looking at it as a smoking cessation aid. That's the role that we would say that it has as a harm-reduction strategy. If that's the case, we're talking about a therapeutic product and we would say that that needs to be regulated through the TGA.

CHAIR: What about a harm-reduction product that may or may not lead to cessation—it's simply better if people are smoking e-cigarettes than ordinary cigarettes?

Prof. Holland : We don't know whether that happens, and we have the potential for products also to help people—particularly younger people—to take up smoking. There are some very large studies that have come out of the US that suggest that, if you are a child who takes up e-cigarettes, the likelihood that you will take up tobacco smoking is much larger.

CHAIR: Isn't the instance of tobacco smoking continuing to fall amongst teenagers in the United States?

Prof. Holland : It is, but what we're saying is we're providing a new gateway for people who might not otherwise have directly come into cigarettes and who will be attracted by fruit loop flavour or cereal flavour.

CHAIR: But this is the question. There are two separate issues which the committee is looking at. One is the regulation of marketing. The other is about the argument for legal availability of e-cigarettes and doing that deliberately to prevent what's actually already occurring in terms of that type of marketing.

Prof. Holland : Yes. As we've said, if this is a harm-reduction strategy, we see it as a smoking cessation device, and that is a therapeutic good and means regulation in our eyes.

Prof. Thompson : It's no different to nicotine replacement. If it's the case that it's a nicotine replacement device and they're marketed that way, a doctor has to give a prescription.

CHAIR: Obviously there is a difference in approach internationally. Britain is most often cited. Effectively—correct me if I'm wrong—the equivalent lung association in Britain has supported e-cigarettes. The argument that's been put back to it is that the entire British medical profession was hoodwinked by one single study from people linked to the tobacco industry. It's not a very good reflection on medical professionals to say that they could be so hoodwinked in such a major developed country.

Prof. Holland : I would sadly suggest that that would not be the only case in which that's occurred. Industry influences are very powerful across a very wide range of products in medicine.

Prof. Thompson : Hence our statement at the beginning.

Mr ZAPPIA: Were any of the studies that you refer to in your opening remarks related to people who have only and exclusively smoked e-cigarettes?

Prof. Thompson : In terms of which aspect?

Mr ZAPPIA: Any aspect at all.

Prof. Thompson : In terms of harm reduction?

Mr ZAPPIA: Yes.

Prof. Thompson : A significant majority of the studies looking at the effect of e-cigarettes on the lung have been laboratory based studies, so they are actually pulling the lung apart, looking down the microscope—

Mr ZAPPIA: That wasn't my question.

Prof. Thompson : I don't understand your question then.

Mr ZAPPIA: My question is: were any of those studies looking at people who exclusively and only smoked e-cigarettes?

Prof. Holland : There are some reports in the literature, but they're quite small because we're very early in the history of e-cigarettes. We know that we've got some reports of things like interstitial lung disease which have been directly related to e-cigarette smoking. That was an Australian report actually, which is quite recent. So, yes, those do exist. They're not large, because we don't yet have the data. We haven't had these products around long enough to be able to follow people for the length of time that's required for chronic respiratory disease to develop and be obvious in large populations. We need that data though.

Prof. Thompson : Many of these studies are case controlled series studies. They're basically looking at a very small cohort and seeing how they go, so as level of evidence it's really quite poor.

Mr ZAPPIA: How long, do you believe, will it be before we've had sufficient time—that is, sufficient years have passed—to be able to rely on the studies?

Prof. Holland : If you look at the example of COPD, which is smoking-related lung disease—that's the one we know the most about. For people to experience symptoms, they may have been smoking for quite a long period over their 20s, 30s or 40s and then may have stopped smoking, and then COPD really becomes apparent by the time they're 55 or 60. So you're looking at a fair gap in time. You're looking at maybe 15 or 20 years of use—whether it's high use or low use, we don't know—before you would really see, in large population studies, those effects coming about. That's why we're concerned, because we've been here with cigarette smoking. We've been in the position where we said that we didn't know—and we didn't know—but that meant that it was too late for a whole generation of people by the time that we did. We're doing something about the younger people, and we don't want to jeopardise the really great gains that we've made there by introducing another product.

Mr ZAPPIA: Outside of Australia, which other countries, to your knowledge, are carrying out studies or have carried out more studies than others?

Prof. Holland : The US have been very active. They're the ones who've done most of the big studies around use, particularly in youth, and the transition to cigarettes. There are some studies taking place in Europe I think, Bruce?

Prof. Thompson : Absolutely. Obviously, in Europe the amount of smoking is higher than in other areas of the world, and they're actively looking at this in terms of the effects of cellular function in the lung, especially in some ways to do harm reduction. However, we don't have them yet. As Anne mentioned before, I think there would be no-one in this room, except potentially the tobacco industry, who would accept why we introduced cigarettes in the first place. If we had the chance to turn back time, we would. That is exactly the situation we're in right now in deciding whether or not we introduce them, and we're saying: not at this stage.

Mr TIM WILSON: Many of the questions I wanted to ask you have already, broadly, been raised. I guess I come in with a certain amount of trepidation about some of the claims that have been made by many people who have presented here. Invariably they start with the position that we don't have enough information to be able to legalise such a product and then very quickly switch to 'the consequences of doing so will be dire' even though it's just been acknowledged and admitted that we don't actually have enough information. So I was wondering if you could provide some insight and commentary on that—about how we can not have enough information to allow something to happen and yet the consequences will be catastrophic and dire. I do think, as a broad reflection, we probably do know which is likely to cause more long-term costs to the health system, which is probably to keep people alive. From the data I've seen in the past in fact—and in no way seeking to extol the virtues—tobacco can lead to early death in its consumption. Actually, when you look at the consequences associated with that, looking at it from a health budget perspective as well as other cost perspectives, it can, bizarrely, reduce costs as well, because you have to factor in the management of chronic conditions and the like. But my real interest is: how can we not have enough information to make something legal yet at the same time say that the consequences will be catastrophic and therefore we can't do it?

CHAIR: Sir Humphrey Appleby very cogently made that argument.

Prof. Holland : I think in our submission we talked about the precautionary principle and the need, when we don't know, to be very cautious about how we proceed with this. The Thoracic Society accepts that it is possible that these devices might have a role in smoking cessation for a group of people. We have things that do that already, but there's another group of people who might benefit from these. That would be in the context of regulation. What we don't accept is tha22222t the risk is acceptable to make this a consumer product, to make it freely available, to make it available to young people and to children, and to potentially cause damage that we don't know will be there for another 20 or 30 years. That's really what's in front of the committee: to decide whether this has a role in smoking cessation as a therapeutic good and what flows from there, which is regulation.

Mr TIM WILSON: I asked this at a previous inquiry. There is the benchmark of setting things. Cessation is the benchmark at which we have to achieve things versus harm reduction. I struggle to understand why, on illicit drugs, for instance, our strategy has to be on harm reduction and yet, at the same time, on this one, it is cessation. Could you explain why you think that should be the case?

Prof. Thompson : It's interesting. I had a honours student who worked in the UK in a medically administered heroin clinic. In the UK, if you're an end-stage heroin addict, you can go to a hospital and the doctor will sit you down and medically administer you with heroin three or four times a week. It was shown in a Lancet article. There were 25,000 people and it reduced the amount of street use down to 25 per cent. Most illicit IV drug users also smoke a significant amount of marijuana, which, as I said before, destroys the lung. It reduces the marijuana smoking to almost zero. In that Lancet article, they clearly showed the intervention on the end-stage users. They are people who will die in 12 months, so they're right at the end of their lives. It reduced the harm to themselves and the community and had a long-term benefit. That was really clear. That has not been demonstrated in e-cigarettes. If you want to do the corollary between the two, that's been demonstrated in a really nice, top-line journal with thousands of people. We have not done that for e-cigarettes.

If you want to use it as a therapeutic good and show that it is equally as good as nicotine replacement therapy for smoking cessation or reduction, it needs to go through all the usual processes, and that's fine. But it is just sold on the market where it's totally unregulated and you don't know what's in it. We can't think of another product that you can buy and inhale. You have oxygen bars. The only thing you can inhale is a therapeutic drug. There's nothing else that I can think of that you can buy off the shelf and say, 'I want to inhale this stuff.' The lung is such a fragile organ; it's just tissue paper inside. We know that the chemicals in this basically break down the lung, so why would we do that? It would be harm minimum for people who already smoke and it would be prescribed. There are plenty of drugs that we know do harm. I take one, but it's medically administered. That's okay in that group of people, but to sell it to children who are unable to give consent and are unable to understand the issues at hand, that's just unconscionable.

Mr TIM WILSON: Respectfully, I don't think anybody—I might be wrong—is arguing that it should be sold unregulated. It's a discussion about what the regulation and marketing environments are like. From our discussions at previous hearings, everybody has accepted that you wouldn't be able to sell said product to a certain age, depending on who's making the decision—if it is Pauline Hanson, it might be 21; for the rest of us it might be 18. It's the environment and how to inform the regulatory environment to make sure they're sold under certain conditions, and that includes the regulation of the product that's available to the point of getting to a consumer.

Prof. Holland : Our position would be that the only potential benefit in the literature, although unproven, is as a smoking cessation device, which makes it a therapeutic good. We know what's in all our other therapeutic goods because the TGA regulates them and they require that, in therapeutic goods, all the ingredients are known and well tested and we understand their toxicology. At the moment, we do not have the information on what's in e-cigarettes.

Prof. Thompson : Made under GMP or the usual story.

CHAIR: Following up from Mr Wilson's point, why isn't this analogous to the debate that took place about the availability of methadone, which was a debate between abstinence and harm minimisation? There was a lot of concern about the introduction of methadone at the time. Methadone clinics were being established around Australia.

Prof. Holland : Methadone, to my understanding, has always been administered in a fairly regulated environment. There are methadone clinics and there are registered people who can supply methadone in very controlled circumstances. In that way, perhaps it is analogous. Perhaps we're saying that, if there is a harm reduction role, we could put this in a regulated environment where we understand that there may be potential harms, but in this particular situation they're outweighed by the potential good if we can achieve smoking cessation.

CHAIR: At the moment you can obviously access nicotine for an e-cigarette from overseas if you have a doctor's prescription. Do you believe that you should be able to access it in Australia if you have a doctor's prescription?

Prof. Holland : I think—and this is just my view—there is a potential role in smoking cessation that we do not have the evidence for yet. I think that it is possible that regulating it so that it could be administered to those people with a doctor's prescription might be useful for some of them. That is acknowledging that we have effective smoking cessation aids that some people use already.

CHAIR: So should I take that as a yes?

Prof. Holland : I think there is a potential role. There is a potential role with appropriate safeguards and regulation as a therapeutic good through the TGA.

CHAIR: One of the issues we are considering is that, when a product becomes so readily available effectively illegally and is therefore in a completely unregulated environment, at what point do you say that the law has failed to control the availability of this product and it is better to have it legally regulated so that you are at least controlling the marketing and the—

Prof. Thompson : Product tax.

CHAIR: Well, exactly! As we have seen prices increase, we are reaching a tipping point where suddenly the profitability of providing it illegally is going to start to become a real issue for policy makers. Isn't there a legitimate argument that this is so readily available in Australia today in an unregulated way that it is better for it to be legally available and regulated than the alternative? That is similar to the argument for decriminalising marijuana, in some respects, which presumably you would be opposed to.

Prof. Thompson : We've never tried.

Prof. Holland : We've never tried to regulate this product. At the moment we have the type of advertising for electronic cigarettes that we used to have 20 or 30 years ago for cigarettes. We are getting the equivalent advertising of the Marlborough man now, and we've made no attempt—

CHAIR: That goes to the strength of the argument, doesn't it?

Prof. Holland : We've made no attempts to regulate that at this point. I think what you are suggesting is that we give up before we even try. I don't think that is unacceptable argument.

Mr TIM WILSON: In defence of the chair, that wasn't the intention of his comment at all. In fact, it reinforces the argument, which is that, if we were to go down a pathway of legalisation of certain products—and there are different ways that we could do it—part of it could involve advertising restrictions consistent with tobacco. That would include health warning labels and all of those sorts of things. These are some of the options to be considered. In addition to that, having products on the market that are illegal but are basically freely accessible if you know how to get them can actually diminish respect for the law, which as a lawmaker I have bit of a problem with.

Prof. Thompson : You are right: there are two arguments going at the moment. You need to never lose sight of the fact that this product does harm. We know it does. So you are basically trying to regulate and legalise a product knowing full well it does harm in itself. If you are going to regulate for people who are documented smokers who are given the option to smoke one of these devices by prescription from their GP then in that environment it would probably be okay. But the problem is you will need to have a lot of regulation. If you are willing to do that, that is a good thing. But we all know it breaks out. We also know that this device does harm. So we can't ever lose sight of that.

CHAIR: But would you say that the two jurisdictions that have decriminalised marijuana have made a mistake and that it is a product that does harm?

Prof. Thompson : The issue with marijuana is that it is a different kettle of fish. We know it destroys the lungs really quickly. Smoking one joint is like smoking 200 or 300 cigarettes in one hit. We know the damage it does is terrible. So the concept of deregulating that I cannot understand. You would basically just be signing death certificates.

Mr TIM WILSON: So the answer to that is, 'Yes, they have made a mistake'?

Prof. Thompson : Yes.

CHAIR: Do you find it a bit perverse that the United States is doing all this work on e-cigarettes while 13 states have legalised marijuana and made it readily available?

Prof. Thompson : America is a bit perverse. That's not a Thoracic Society comment, by the way; that's Bruce Thompson saying that! Totally. At an American Thoracic Society conference last year in San Francisco I fired up the television and it said that one in four children who smoke e-cigarettes progress to smoking. That is in a state where they are legal. I was just sitting there going, 'Only in America.' That's a real concern. So regulation needs to be extremely tight. You have a group of people who have a death wish by smoking cigarettes. We could potentially reduce their harm if we believe that is going to be the case. If we could then just allow those people to have the device in a regulated way then that would not be a bad thing, in my personal view.

CHAIR: I come back to the point I made earlier on. We get conflicting evidence about the role of e-cigarettes as a gateway and their use amongst children. Some of the evidence presented to us is that the rates of smoking amongst adolescents in the United States is falling. But in the UK since e-cigarettes were made available there has been a faster rate, although from a higher point, of reduction than we are currently experiencing in Australia. I was just wondering whether you could elaborate on that further but also specifically whether you have had a chance to look at the regulatory environment that New Zealand is introducing. It has been put to us as that, if we were to do it, it's the best practice now around the world?

Prof. Thompson : I don't know the regulatory environment in New Zealand, sorry, so I can't comment. What are they doing?

CHAIR: We are about to find out shortly. Some people have put to us that Britain's way is not the way to do it but New Zealand's is, so it is obviously a lot tighter.

Prof. Thompson : I imagine Britain are now thinking, 'We've made a mistake.' In terms of the physicians from the UK who I speak to, they are just—

CHAIR: We have been bombarded by people wanting to come and tell us why we are making a mistake from the health profession of the United Kingdom as well.

Prof. Thompson : I think respiratory physicians have a different view.

CHAIR: The lung association of Great Britain doesn't. Thank you for your time today.

Prof. Thompson : Our pleasure.

CHAIR: Can I just remind you, if you would like to provide any additional information arising from today, to do so to the committee secretariat by Thursday, 19 October. We will also send you a Hansard transcript of the evidence you've given today. Let us know if you want to make any corrections to that.