LITT, Associate Professor John, Deputy Chair, RACGP Expert Committee on Quality Care, Royal Australian College of General Practitioners

Evidence was taken via teleconference—

CHAIR: Welcome, Professor Litt. I'll just go through the formalities I need to go through. Firstly, do you have any objection to being recorded by the media, if they happen to be present?

Prof. Litt : No, that's fine. The only thing I can do with the media is that sometimes what they put in gets changed from the context—

CHAIR: Really? That's something we've never experienced before!

Mr TIM WILSON: Welcome to our life!

Prof. Litt : I would have a look at it for correctness, but I appreciate their editorial style is left to them. The short answer is that it's fine, but sometimes they will take things out of context; that's the risk.

CHAIR: Secondly, I need to formally remind you that these 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. We've got the written submission that was signed by Dr Seidel. Would you like to make an opening statement, Professor Litt?

Prof. Litt : My background is that I've been an academic, GP and public health physician, but I retired about 18 months ago. I'm currently the deputy chair of the RACGP national quality committee. That's the group that oversees most of the clinical guideline development and approval for GPs on behalf of the college of GPs. I'm also a member of our smoking cessation expert advisory group. We've produced a document, Supporting smoking cessation: a guide for health professionals. The first edition came out in 2004, it was last updated in 2014 and we're currently in the process of revising it.

I have one potential conflict of interest to declare. I am a member of the Pfizer varenicline expert advisory group. I last attended a meeting of this group about four years ago.

I imagine that the members actually have the college submission in front of them. You will see that we had a relatively brief section in the 2014 handbook and indicated that e-cigarettes could have a role in cessation but further research was needed before a recommendation of their use could be confidently made. There was particular concern around the lack of evidence for short-term efficacy in terms of actually assisting people to quit smoking and around their short-term and long-term safety, particularly for people with chronic disease. These are the two things highlighted.

The other two comments made in the submission were that the college of GPs only supports general practice prescribing of medicines and therapeutic devices that are registered or approved through the Therapeutic Goods Administration, and that we recognise that e-cigarettes may have an important role and that we actually support further research into their safety and efficacy as aids to assist people in smoking cessation. My final comment would be with the NHMRC review of that. We would support a lot of the comments made there that there is further research needed. I do have a few other comments I could make on some of the advantages and disadvantages of electronic cigarettes, but I imagine that you have actually been presented with that by a range of other groups.

CHAIR: Yes, that's fair to say. If you're happy we might move to questioning.

Prof. Litt : Can I just list the headings of each of those just to be sure. The advantages can be grouped into three: that people are promoting it as a safer alternative to smoking; that there are some ethical reasons around harm minimisation, that we should be offering electronic cigarettes because they are less harmful than conventional tobacco; and that a number of people would suggest that there is some evidence that they reduce regular conventional tobacco use and potentially a decline in smoking rates.

There are probably three main areas of disadvantages: that their safety has not been established, particularly in the longer time; that in terms of assisting smokers to quit, the evidence is not out yet, and there are currently trials underway to try and address that; and that there are a range of other public health issues about the potential to renormalise cigarettes—a gateway to using regular cigarettes, particularly amongst youth—and the fact that it might actually prolong the duration of smoking for people who smoke and actually not deter them from ultimately quitting, which would be the desired goal.

CHAIR: By way of background, could you step us through the regulatory environment insofar as GPs in Australia are able to effectively prescribe e-cigarettes or the nicotine that goes into an e-cigarette if they believe it is likely to succeed as a cessation device. Of course, the patient then has to source that nicotine offshore.

Prof. Litt : Are you asking me to talk about the current system?

CHAIR: Yes. Can you explain the regulatory controls on that? Obviously, that reflects the fact that there is no TGA approval.

Prof. Litt : Sure. In a nutshell, it's difficult. Patients can get a licence to get nicotine. They can get three months at a time, but they require a prescription from their GPs. The paperwork to fill that out is that the GP has to actually outline the benefits to the particular patient and outline some of the benefits of using such a product. It is quite onerous. The college have actually reported separately to the review of that sort of process. I can't cite how many GPs would be doing that, but I would say that it is problematic. I don't have personal experience of people coming to me to ask to do that, but it does make it extremely difficult for people who want to get access to some form of nicotine and import it, as it current stands.

CHAIR: Can you remind me how that is done? Obviously, it is a product not approved as a cessation device by the TGA.

Prof. Litt : There's a regulatory form that has to be completed by the general practitioner and sent off to the TGA for review. The GP has to fill out a number of the sections of that. I can send that separately to you. As I said, the college have actually separately commented on that and said it is onerous. A similar issue applies to the importation of medical marijuana, which is also currently getting some scrutiny. If you wanted the exact category for that, I would have to access the form and look through it.

CHAIR: That would be very helpful.

Prof. Litt : Okay. I can do that and send it on to you. But I guess the comment is that GPs would be doing it infrequently and find it particularly onerous.

CHAIR: My second question goes to the nub of the issue. The submission that the college have submitted highlights both the possible potential of e-cigarettes but also the gaps in knowledge and therefore all the caveats that go with that. What would your recommendation be to the committee as to the path it should go down? The argument is recognising that there is an established process through the TGA if these products are provided as a cessation device and different process if they are just provided as a substitution device or just another legally available product.

Prof. Litt : I think there are two stages in this. I think a major question is the claim that they actually reduce consumption long term—both the number and volume of cigarette smoke—and ultimately that people are going to quit. The NHMRC has sponsored some research to look at providing rigorous evidence about the claims that it does lead to reduction and cessation. If that is established and the evidence is robust then the TGA would have an avenue to regulate it and it would come with all the normal provisos of a TGA regulation. So that would make it easier. The challenge will be that some groups will see that as medicalising the issue, but it would give people a lot of reassurance about the safety, the production of such materials and the fact that they actually have an impact.

CHAIR: In the evidence we have received there has been debate about whether it works as a cessation device. During this inquiry we have been quoted statistics that justify both sides of that argument. Then there is the second threshold of whether the research is in in a way that would allow you to allow people to use this product at all safely. Some have argued that theoretically it could be more harmful than smoking. Others have said it is just simply unknown.

Prof. Litt : I appreciate that there is a spectrum and it has actually led to some quite different views in the public health community. This is my two bits worth. I think most people would say that the level of evidence is not strong enough. The best assembled systematic review is the Cochrane. You would be familiar with the Cochrane centre that assembles research evidence in a transparent and rigorous manner to provide the best possible answers to a range of clinical questions. They're saying that the studies are too small, the quality of the studies are too variable and the follow-up is not long enough. I don't think there are many people who are saying that there is a really clear-cut benefit. There is indirect evidence that people are saying it is helping them to stop smoking. In some areas smoking rates are dropping and, similarly, people are shifting away from using conventional tobaccos to e-cigarettes.

Most would actually accept that the burden of various toxins and chemicals within tobacco is far worse than it is in electronic cigarettes, but it's a spectrum. Again most would agree that there are still products within electronic cigarettes that are potentially toxic. There are very small particulate materials—with a diameter of about 2.5 microns—that get down into the smaller airways in your lungs, and 2.5 micron sized particles have been associated with lung cancer. There is also aldehyde and formaldehyde production in the combustion process. Even though there has been a debate on that, a lot of people would stress that they are potentially carcinogenic. So it's not a completely safe product. The second element of that is that we actually need to look at more rigorously the safety, and some of that would happen as part of the TGA process to do that.

I think the first step is that we actually need evidence, both around the safety and around the benefit of producing cessation, that is acceptable to a broad panel of people. I appreciate that the AMA, the Cancer Council and the Heart Foundation don't think that that evidence is in. I think a lot of other people internationally would agree with that, even though it is freely available in the US and available to a different sort of extent within the UK.

CHAIR: That's a good segue to my last question. I presume the Royal College of Physicians in the United Kingdom is your sister organisation.

Prof. Litt : Not directly. It would be the royal college of GPs. But they are a professional group. I know that they have come out in support of electronic cigarettes, but they also have made some comments that there is still concern. They say in one of their summaries that 'e-cigarettes are not currently made to medicine standards and are probably more hazardous than nicotine replacement therapy'. That is their Tobacco Advisory Group in their latest update in 2016. While they're generally supportive of that, and in the UK they certainly are widely using it, I thought that was an interesting comment.

CHAIR: Thank you.

Mr ZAPPIA: Professor, thanks for your comments thus far. I take it from your comments that you would support the TGA regulating the sale of e-cigarettes.

Prof. Litt : Once there actually is evidence of effectiveness. I think that's the first step. The trials that are currently being sponsored by the NHMRC and are happening around the world at the moment are probably going to be available within the next 12 to 18 months or so, and that will provide us with a lot more evidence around whether they are effective.

I think the safety issue is a separate one, and again there needs to be more data about that. The TGA would regulate on the safety, but what's currently before us at the moment, when it's not regulating it, is that that is a mixed bag, and we need to get that information in a much more rigorous and presentable format. The TGA looking at regulating e-cigarettes would give an opportunity, but that should probably wait until we have evidence around whether they actually increase the rate of quitting.

Mr ZAPPIA: In your earlier comments, you referred to some of the risks and concerns that you have about e-cigarettes. Do you have any research or evidence that e-cigarettes are more dangerous than normal cigarettes?

Prof. Litt : I don't think they're more dangerous. As I said, the bulk of chemicals in conventional tobacco are not in electronic cigarettes, so there is a significantly lower burden from having e-cigarettes. But there are other sorts of dangers that can be either unintended or hard to anticipate. One example would be that there's a significant promotion of non-nicotine electronic cigarettes to children in various formats, and it's actually renormalising smoking cessation. Australia's done a terrific job in the last 15 to 20 years of increasing the control on tobacco products and getting the rate of smoking down to a very low level. So a lot of harm could happen by having availability of these sorts of products in the market, looking like cigarettes and leading to a potential gateway for people to smoke. So, from a health point of view, I think it's pretty clear that the e-cigarettes are likely to be more safe than conventional tobacco, but they're not without safety risks. The only way to absolutely reduce the risk is not to ingest any nicotine or any of the ingredients of either e-cigarettes or tobacco.

Mr ZAPPIA: Would it be reasonable to conclude that your main concern is not what you know about them but what you don't know about them?

Prof. Litt : Because of the mixed evidence around that, we don't have enough research to look at some of those questions and provide a policy statement. We don't know the long-term effects of inhaling some of the substances within e-cigarettes. Some of these things, like the glycerol, cause no problem when ingested, but there is some evidence that, if you inhale them, they can lead to various things happening within the lungs. I think that evidence needs to be more systematically scrutinised, and that's something which the NHMRC could do as a process. In New Zealand they've set up a technical advisory group that will probably answer some of those sorts of questions and assemble that evidence so we can take note of what other people are doing to do that. I think that information does need to become more available to people to reassure them, because we are promoting a product that we're saying is safe when we don't know the answers to that, whereas, when we're recommending other nicotine replacement products that are in the market currently, we know about the effects of nicotine, more or less, and it doesn't have all those other additional things within the nicotine replacement products that the e-cigarettes might have.

Mr ZAPPIA: Thank you.

Mr TIM WILSON: All my questions have been asked.

CHAIR: I think that exhausts our line of questioning, Professor Litt. You followed a morning of health experts, so I think that's why. If you'd been first, there would have been a plethora more questions, but, as you are last in this category, a lot of the questions—

Prof. Litt : You had the proper experts before. A GP is a generalist, so we try to be problem solvers most of the time, and we don't necessarily have the depth of knowledge that some of the specialists do.

I'd just take on board the homework. You would probably like to get a copy of the current form that GPs have to fill out to get access to medicines that are not TGA approved. I know that that is being reviewed. I could see if I could track down what the college has said about that, because I think they've prepared a response to that. I think it came up in relation to medical marijuana, which is another controversial area.

CHAIR: Thank you, and also for your time today. If you are able to provide that evidence to the committee secretariat by 19 October, that would be helpful. You will also be provided with a Hansard transcript of today's proceedings. If there are any corrections or additional matters you want to raise as a result of that, please do so through the secretariat.