BARTONE, Dr Tony, Vice-President, Australian Medical Association

[10:02]

CHAIR: Welcome. I remind you that these are formal proceedings of parliament. The giving of false or misleading evidence is a serious matter and may be regarded as a contempt of the parliament. The evidence you give today will be recorded by Hansard and attracts parliamentary privilege. We have your written submission as well. I invite you to make an opening statement.

Dr Bartone : Thank you for the opportunity to present here today. Our statement will be brief today because the AMA note and object in the strongest terms the involvement of the tobacco industry in these proceedings. The AMA want to note our concerns. We are dismayed to see the ongoing involvement. The AMA, as a matter of policy, does not meet with or engage in discussions with the tobacco industry. The primary purpose of the tobacco industry is to make profit for shareholders through the sale of tobacco products. That they are diversifying into e-cigarettes does not exclude their commercial conflict of interest in these proceedings.

As doctors we see the harm caused by tobacco smoking. Nicotine is extremely addictive, a fact the tobacco industry has capitalised on for decades. We recognise that two in three smokers will die as a result of tobacco smoking. We recognise the importance of smoking cessation. So I can assure you that if the evidence on e-cigarettes stacked up the AMA would be one of its most vocal supporters. However, the evidence simply isn't there. Early this year the National Health and Medical Research Council reiterated that there was not sufficient evidence to recognise the role of e-cigarettes as cessation aids.

We must also recognise the evidence does highlight risks associated with e-cigarettes. The AMA recognises there is a potential that e-cigarettes will also normalise the act of smoking. Further, there is some evidence that e-cigarettes may delay a decision to quit, with some smokers using both e-cigarettes and tobacco cigarettes. Like may other health organisations, the AMA is guided by the precautionary principle: in the absence of scientific consensus, and where there is risk of doing harm, extreme caution must be exercised. In revising it's 2015 position statement the AMA federal policy council agreed on the following:

E-cigarettes and the related products should only be available to those people aged 18 years and over and the marketing and advertising of e-cigarettes should be subject to the same restrictions as cigarettes; and

E-cigarettes must not be marketed as cessation aids as such claims are not supported by evidence at this time.

Like many of my colleagues here today, I find it deeply concerning that so much of the evidence being provided by tobacco companies argues for moving towards a smoke-free society. This simply isn't true. In developed countries where there is increasing regulation, the business model is to move to other ways to maintain and grow nicotine addiction. These companies continue to engage in underhand marketing practices, which see thousands of people smoking.

The National Health and Medical Research Council agreed that there is currently insufficient evidence to indicate that the e-cigarettes can be effective cessation aids. They have funded a large amount of research to explore the matter further, and these results will be available in the next few years. The Australian Consumer and Competition Commission successfully pursued claims that e-cigarettes did not contain harmful chemicals and carcinogens. You have also heard from my colleagues at the Thoracic Society today, and they have concerns about the impacts of vaping. The Australian community has a right to assume and expect the highest level of safety in those products that are available to them, particularly those products inhaled or ingested.

The AMA is also extremely concerned that, from previous hearings with representatives from the tobacco industry and other cigarette advocates, the discussion appears to be moving from one of e-cigarettes being used as cessation aids to one of e-cigarettes being used indefinitely. Certain advocates have argued that e-cigarette usage should not be encouraged to even reduce the strength of their nicotine solution over time. Other cessation products have cessation as a goal; it might take some time, but eventually one quits. E-cigarettes advocates are arguing that e-cigarettes should be used as smoking cessation products, but are also conceding that complete cessation is not their goal.

Outside of my role as vice-president of the AMA, I am a GP. I have supported countless patients who have decided to quit smoking. There are a range of options available to my patients who need support to quit. There is nicotine replacement therapy and there are other pharmaceuticals. There is also interpersonal support available through avenues such as the Quitline, counselling and so on. Based on my discussions with patients, we decide which support tools are best suited to their attempt to quit. When used appropriately, all cessation products are used for a few months, but the goal is to eventually stop nicotine addiction. Clearly, the business model for tobacco companies is to foster and maintain nicotine addiction. Their aim is not cessation but product diversification. We know that adolescent and young adult brains are more vulnerable to the influences of addictive substances such as nicotine and that commencing at a young age can make a quit attempt even more difficult. The AMA is concerned about the proliferation of e-cigarettes in Australia, which would feasibly see more young people inadvertently become nicotine addicts.

I also want to briefly highlight the safety concerns about batteries used in e-cigarettes, with reports of these devices exploding and causing quite serious injuries. It's also worthwhile highlighting that some lithium batteries can pose a serious health risk to small young children, who are inclined to swallow them. The AMA is also concerned about nicotine-containing solutions, which pose a risk to young children. These products are appealing; they come in a variety of fruity flavours and confectionary colours and are not required to have childproof mechanisms. International experience indicates that, as e-cigarette use increases, so do cases of accidental nicotine poisoning in children.

There is an argument for the reduction in smoking prevalence, which has flatlined over time. However, the lack of evidence around the cessation, combined with the potential risks, means that the AMA cannot yet support the wider availability of e-cigarettes. This argument does not recognise that Australia has some extremely well-researched and evidence-based measures such as plain paper packaging and increasing tobacco excise, which have already lowered smoking prevalence below that of other countries. We must not be complacent. The marketing of e-cigarettes is predominantly online. It's sophisticated, and it's designed to entice young consumers. Let's be clear about that. The marketing of products such as nicotine replacement therapy is in stark contrast. These are not desirable consumer products. We do not see young people being compelled to improve their image by using nicotine replacement products. The AMA believes the marketing and advertising of e-cigarettes should be subject to the same restrictions that are applied to tobacco cigarettes. Essentially, the AMA does not believe there is a role for the promotion of these products, which maintain nicotine addiction. I would like to also support comments by Dr Becky Freeman in a previous hearing that any changes to e-cigarette regulation must fully consider misleading and harmful marketing and advertising practices which were effectively pursued by the ACCC.

Let me finally look at the issue of them as consumer products. Nicotine is derived from tobacco. It appears that big tobacco companies have now moved from promoting tobacco to promoting nicotine in a more refined form. In a previous hearing, it was asserted that nicotine should essentially be unregulated and available in easy-access locations and that establishing the appropriate strength of nicotine liquid is best done by trial and error at a retail outlet. Such assertions are ludicrous. It's even been compared to methadone in its use. Can you imagine a world where methadone was heavily advertised and new and existing users were encouraged to shop around and look for a source of methadone?

The AMA has confidence in the existing regulatory systems through the Therapeutic Goods Administration and the Pharmaceutical Benefits Advisory Committee and that these are the independent expert bodies who are responsible for the approval, scheduling and potential subsidies available to such therapeutic products. The AMA recognises their role in making such decisions and believes that they would be the appropriate bodies should e-cigarette companies wish to change nicotine scheduling and make therapeutic claims about e-cigarettes.

Let me remind everyone, in closing, that tobacco smoking is the leading cause of chronic disease and death in Australia and warrants a range of policy responses, including plain tobacco packaging, tobacco excises, advertising bans and subsidised access to recognised cessation aids. Each year, smoking kills an estimated 15,000 Australians and costs the Australian community $31½ billion. Nicotine is extremely addictive, a factor the tobacco industry has capitalised on for decades. Thank you.

CHAIR: Thank you very much.

Mr ZAPPIA: Dr Bartone, thank you for that opening statement. Can I take it from your statement that the AMA would support the regulation or sale of e-cigarettes if it were TGA approved?

Dr Bartone : Certainly. The TGA is one of the foremost bodies in the world when it comes to providing and ensuring safe and quality medicines and therapies on our market. If the evidence were there and the TGA approved it, of course we would be the first in line to enlist e-cigarettes in our repertoire of usage when it comes to trying to get our patients to quit smoking.

Mr ZAPPIA: My other question is this: you and your medicines prescribe drugs every day which have contraindications.

Dr Bartone : Correct.

Mr ZAPPIA: And my understanding—correct me if I'm wrong—is that you would do so on the basis that the benefit is much greater than the contraindication that could occur. Given that the evidence as to the effects of e-cigarettes is still not in—and I make that statement on the basis of the evidence of many of the witnesses that have presented to us that we still need to do a lot more research—if it were the case that e-cigarettes were less harmful than normal tobacco cigarettes, what would be the AMA's position then?

Dr Bartone : We are always informed by evidence, in everything that we do, whether it be public health measures or in our own consulting rooms when we are dealing with our own patients. So we follow the evidence. If the evidence clearly shows that there is a role for e-cigarettes to be used as cessation products, we would be the first to enlist them as part of our repertoire. You made the point about contraindications and precautions and side-effects of drugs. They are on the basis of years and years of thorough research. They go through extensive phase 1, 2 and 3 trials before they are even put up by a sponsor for adoption onto the therapeutic goods register. So they've gone through an extensive listing and understanding. We just don't have that with e-cigarettes at the moment, and we really do need to be sure that we are not going to do more harm than good. So, at this stage, it's premature. But, when the evidence is in, and if it does show that there is clearly a role, we will obviously adopt that position then.

Mr TIM WILSON: Thank you for your presentation. My question is: we have a problem where we have a product that is essentially unlawful but still relatively freely available for some people who import it. We have had this discussion with others—that, by making it legal in a regulated way, at least we can manage some of the problems associated with the product. Do you have any observations on that and whether you think it would be better to provide a pathway for regulated access, to deal with those consequences, or would you rather the harm coming from it being illegally accessed?

Dr Bartone : My position starts from one of doing no harm. That essentially guides all my activity and all my efforts in recommending what I do as a medical practitioner. So I will argue on the basis of zero harm. If that can't be achieved then we need to work out how we can minimise that harm and minimise that use. We have other, well-documented and well-researched ways of reducing the rates of smoking. Australia has an exemplary record in this space and has reduced smoking rates from percentages in the mid-20s to about 12.1 per cent, in the latest AIHW rates, and still going down. The government has a target of a 10 per cent smoking rate by 2018. In the short term, that does not appear to be achievable, but it still needs to proceed in that direction. I can't see anything that would really encourage me to use something that I know is still going to cause harm. That is really the bottom line. At this stage, we don't have any evidence to say that it causes zero harm. We don't have any evidence to say that it will help as a cessation aid. We need to follow the evidence. I've been very concerned about using something that has unproven carcinogens and the effects of those and where there is the risk of chronic disease burden through the rest of life, even if there is a reduction in mortality. And it is still normalising the act of smoking, which can then lead to someone taking up the behaviour later on. We need to recognise the insidiousness of smoking. There is no safe way of talking about it. Smoking causes an enormous amount of harm, of chronic disease burden and of mortality in this community, and I have yet to meet a patient who, in their final days, has said, 'You know, I wish I'd smoked more.'

Mr TIM WILSON: Respectfully, that wasn't the question. As legislators, we have to look at the evidence available to us, which is, as we know full well, that people are already importing or are able to buy vaporisers and they are importing nicotine. There is a potential for harm that is being caused already because of consumption in an unregulated environment in comparison with a regulated environment where we could, say, stop access to flavours, limit marketing arrangements and minimise access. Is there a recognition from the AMA that there is harm being done, if that is its position already, and that it might be more desirable to risk manage and regulate access to try and reduce the harm?

Dr Bartone : Apologies if I missed the intent. In my opening statement, I made the point that in our position paper we have already said that e-cigarettes mustn't be marketed as cessation aids but that the related products should only be available to those people over 18 years and, of course, through the regulation that would accompany such positioning.

Mr TIM WILSON: Can I take it from that statement that the way we would regulate access to vaporisers and/or nicotine would be to make sure that it's for people over the age of 18 and that standardised measures apply, as they do to the tobacco industry and tobacco based products, like marketing restrictions and potential limitations on flavours and other types of additives to a product, but otherwise there could be an environment where it could legal and accessible?

Dr Bartone : The behaviour towards the sale and supply of e-cigarettes should be exactly the same as that which applies to cigarettes. There should be no distinction between the two.

CHAIR: You said there was no evidence that e-cigarettes were effective as a cessation device. We've obviously received considerable feedback from the community and from people who have said that this was the only thing that got them off cigarettes. It is currently legally approved for GPs to prescribe the use of e-cigarettes, as long as the nicotine is imported as a cessation device. Are you saying that that regime as it currently exists is wrong and that those doctors are foolhardy in going down that path?

Dr Bartone : I am saying that the evidence is not in yet to make a blanket endorsement of that as a pathway forward. Of course, every medical practitioner will make up his or her mind as to what treatment they will enlist. There are a variety of medical treatments that are used off label, so to speak, that are available at any one time. Because of anecdotal evidence or because it's used in an ad hoc and opportunistic way should not be seen as an endorsement that it's available for the community as a whole. That's where there's a risk of wider harm and wider unnecessary usage and take-up and acceptance of an activity where the evidence is not in about its safety.

CHAIR: What would you say to those scores of people—and I've lost count of the number of people—who have conveyed their individual stories to this committee about their lifelong addiction to nicotine that was only brought to an end through using e-cigarettes as a cessation device? Why shouldn't the committee have regard to that testimony?

Dr Bartone : Because science and medicine, through the passage of time, have always relied upon the irrefutable evidence not what the prevailing winds might be showing.

CHAIR: These are people who have written to us by way of formal submission and said that they tried everything else, that they have been lifelong smokers and e-cigarettes were the only thing that got them off nicotine and smoking. Why shouldn't we have regard to that evidence?

Dr Bartone : Anything which has helped some people get off the habit of smoking has to be looked at. I agree with you from your position there, however I have to always follow the evidence. If I didn't follow the evidence, I would have probably reduced my support of the MMR vaccine. I would've probably said, 'You know what, there are some reports from some person in the UK who says that it causes other untold harms.' We would be looking at public health issues far in excess of what we're currently seeing, which are the low but still substantiated episodes of measles epidemics that we've seen in the papers in the last few weeks and that we know are still sporadically happening in this country. From a position of relative obscurity, it's returning and recurring. It's about being really very clear about the sum total of the irrefutable evidence that's gone through the peer review. That's what we've always based our findings on—from time in memorial. It's observed fact. It's reproducing it and then proving that that's the expected outcome. There are examples of such anecdotal behaviour on many fronts. Not all come to fruition. Of course, observation is the first step in any scientific thesis and prospective investigation, but you've then got to prove that, so it's only part of the argument and only part of the process.

Mr TIM WILSON: The point is: we agree that we have to follow the evidence. The evidence, though, is mixed. If we were to properly analyse a lot of the presentations that have been presented to us by different groups, there are some people who are saying, 'Making access to these carte blanche without any regulation would be detrimental to the community.' I don't want to speak on behalf of other committee members, but I wouldn't be shocked if they shared that concerned. Equally, we have, in the evidence before us, people who are saying that, as the chair has already stated, it has significantly assisted them in cessation. It may be the only means to do so, and we have to make assessments on the basis of that evidence. While there are anecdotal or personal stories that justify that component, the previous presenters from the Thoracic Society talked about the fact that similar problems can emerge from medical research, including from, perhaps, even peer-reviewed research where processes are taken up and then then problems are identified later. The task for us is finding the sweet spot between those two in order to deal with how to manage it.

Dr Bartone : Let me put the reverse to you. How would we all feel if we suddenly delved into a product that didn't have the evidence saying completely that it doesn't cause any other harm and saying that some of these carcinogens produce cancers of different types and different mortality and morbidity in the few years ahead? How do we feel about the generation of young children who are coming through who have already started to invest in minimisation behaviour—be it alcohol, be it smoking and be it other drug taking. We need to be sure that whatever we're allowing to be registered and used in an approved sense doesn't have the ability to cause unforeseen harm. We can't say hand on heart that that's the case. We've got a situation where we have a product, and that product has a known mortality, morbidity and chronic illness burden on the community. To say that anything that reduces that but still has an acceptable rate of failure is okay is just really something that I can't accept.

CHAIR: Can I just follow that up. This is what I find perplexing: we know that smoking kills in the thousands. If we have an alternate product that can still do harm, but, in the process, saves thousands of lives—maybe not every life—

Mr TIM WILSON: Extends thousands of lives.

CHAIR: If there was a product that extends thousands of lives and potentially saves thousands of lives, but there is still harm done, wouldn't you go for the lives?

Dr Bartone : What you would do is you would put all of your efforts into finding the research and proving it one way or the other.

CHAIR: What would be the threshold? Basically, the evidence that we've had has either been that it does less harm than cigarette smoking or that the jury's out and we don't know. The claims around less harm have ranged up to 95 per cent less harm. What is the threshold that becomes an acceptable point? If 95 per cent was accurate, would you say, 'That's a good basis, then, for legalising it'?

Dr Bartone : I'm not going to be tied to a number other than 100 per cent because—

CHAIR: So you would have to be convinced that it did no harm at all?

Dr Bartone : Yes, before I would personally look at that. I want to be very clear about this: when the epidemiological, statistical and full evidence is in, then we can make a reasonable comparison about the true impact. There might be an argument that people will put up at that stage, but we don't even know what those factors are. So we are really more proceeding by a hope, a wing and a prayer that we can do something positive and then that makes us feel good about something that is ultimately killing thousands of Australians every year.

CHAIR: That is what I find perplexing. Basically you are saying that, even if it killed fewer, the fact that it still kills any means it should be—

Dr Bartone : I want to be sure that I'm not going to do any more harm, and that isn't in—

CHAIR: That's a different question. More harm is different to less harm.

Dr Bartone : That's not proven either. That is not irrefutably made clear at the moment from my understanding. In our rush to do less harm we don't look at the full quantum of information and evidence available. We need to give that full-scale-of-the-impact information to the people who will ultimately be the consumers.

CHAIR: Does the AMA support the availability of medicinal cannabis? Has it supported our reforms federally and at the state level?

Dr Bartone : Our position is very clear on that and it is fairly extensive, but very quickly in the time frame here it is one of following the evidence. There is some very low level evidence that medicinal cannabis may have a role to play in the management of certain specific conditions when other medication and treatments have failed or found to be recalcitrant. So there is a very narrow accepted area where there may be a role for medicinal cannabis.

CHAIR: So you don't think we should have waited 20 years to do the studies to see whether there were long-term impacts for the use of medicinal cannabis.

Dr Bartone : Those studies are already going through at the moment. There are extensive multicentre trials up and down the eastern seaboard of Australia currently either in process or about to begin.

CHAIR: So have we jumped the gun in making it available before that research has concluded?

Dr Bartone : Our position on medicinal cannabis is very clear, and I can provide it to you at the end of this meeting electronically if you wish. We have said very clearly and very cogently on many occasions that there may be a role for it. It has a very narrow window and it's really to be used in those conditions where there has been some evidence that it may have a role where other products have failed.

CHAIR: Presumably some form of epilepsy is an example of where it's useful.

Dr Bartone : In paediatric epilepsy, yes, where other medications have failed.

CHAIR: So the position of the AMA is that the benefits of medicinal cannabis outweigh not knowing the risks, so it's a harm minimisation approach.

Dr Bartone : Some of the trials go back to the mid-1980s in some parts of the world. Those trials have been reviewed and are being reascertained through the vigour of fair independent researchers as we speak. A university in New South Wales is currently going through that evidence on behalf of a number of organisations, including the TGA, which is looking at all the information at the moment.

Mr ZAPPIA: Dr Bartone, you quite rightly referred to in your presentation the risks associated with the batteries, so my question is: is the AMA's main concern with these cigarettes the fact that it doesn't know all of the ingredients that are within them and the risks that they present as opposed to its concern about what it does know about them? In other words, is your concern not predominantly related to what you don't know about them as opposed to what you do know about them?

Dr Bartone : I don't know that one set of concerns outweighs the other significantly. Both sets of concerns are really significant in our position and our apprehension about using the products.

Mr ZAPPIA: Is your concern predominantly related to nicotine levels or is it related to the possible addition of other chemicals within e-cigarettes?

Dr Bartone : Our concern is about the addictive properties of nicotine, its highly addictive nature. Our concern is about the other properties in there and what we don't know about them. We have concerns also about the actual vaping or smoking behaviour associated with using e-cigarettes, which normalises the activity, and the marketing, and the social messaging entailed in the combination of using those products, to the community that has yet to take on smoking. So it is the whole gamut.

Mr ZAPPIA: Is the research relating to nicotine levels still one of the uncertainties?

Dr Bartone : We know that nicotine is highly addictive and that any product based on the use of an addictive product such as nicotine is a concern.

CHAIR: Thank you for joining us today, Dr Bartone. You will be provided with a Hansard transcript of today's proceedings and if there are any corrections to that could you come back through the committee secretariat by 21 October. If there is any additional information you think would assist the committee with its inquiry please feel free to provide that as well.