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Evidence from trials of e-cigarettes could impact the current development of national clinical guidelines on smoking cessation techniques, this newspaper has been told.
Earlier this month, HIQA published its health technology assessment (HTA) comparing the cost-effectiveness of smoking cessation interventions. On the issue of e-cigarettes, it found that the Minister for Health should “await the results of ongoing trials before deciding whether to recommend e-cigarettes”.
However, HIQA’s Director of HTA Dr Máirín Ryan told the Medical Independent (MI) that clinical guidelines on smoking cessation are currently being developed, which could be impacted by evidence due soon from ongoing trials.
“The purpose of this HTA is to look at the evidence as it is at the moment,” Dr Ryan told MI. “The HSE is developing smoking cessation guidelines, which is intended to become one of the national clinical guidelines endorsed by the Minister.
“One of HIQA’s new roles is to provide, on an ongoing basis, the evidence for all the national clinical guidelines that go through the National Clinical Effectiveness Committee. The prerequisite for a national clinical guideline endorsement by the Minister is that they have to be updated constantly as new evidence emerges and we will be responsible for doing that.
Dr Máirin Ryan, Director of HTA, HIQA
“So as the evidence emerges [on e-cigarettes], we will be reviewing it and feeding it back to the guideline developers, so that different decisions can be made as the evidence becomes available.”
Dr Ryan said that the “clinical guidelines group has been formed already, so we have started work on it. They now have the evidence-base, because we have provided the HTA and they have started developing it now… we will be supporting them as the evidence emerges.”
A HSE spokesperson told MI that “the HSE Tobacco-Free Ireland Programme convened a Clinical Guideline Development Group in early 2017 to begin work on developing National Clinical Guidelines”. The spokesperson added that the group first met this month (April) and “is aiming to submit draft guidelines for review by the National Clinical Effectiveness Committee in 2018”.
Dr Ryan said that “six randomised trials are ongoing and they contain almost a 1,000 patients [each] and the first of them will report towards the end of this year.
“So the evidence [on e-cigarettes] is emerging very quickly. That will allow us to conclude definitively on the effectiveness and conclude that they are better than no active treatment.
“What we are saying [in the most recent HTA] is that the evidence that is there at the moment is promising. But it’s insufficient at this stage to reliably conclude on the effectiveness of e-cigarettes.”
Dr Ryan agrees that this current “wait-and-see” position may come across as somewhat unclear to doctors and patients in respect of e-cigarettes.
“Yes, there is quite a diverse opinion out there in the public health world, in that the UK is quite ‘pro’ using e-cigarettes, whereas there are groups in the US that are more concerned about it; they are concerned over issues like that you continue to have a nicotine addiction [when using e-cigarettes],” said Dr Ryan.
“Now, obviously that is the same with nicotine replacement therapy (NRT), but they also have concerns around long-term safety.”
In respiratory medicine, advising patients to use e-cigarettes or ‘vaping’ as a way to cease smoking is becoming more commonplace.
Dr Alexander Deegan, Consultant Respiratory and General Physician at the Blackrock Clinic, Dublin, told MI that e-cigarettes are being cited more frequently by clinicians as a way of assisting patients to cease smoking.
A recent clinical report on COPD in MI written by members of the Respiratory Professorial Unit in Tallaght Hospital, Dublin, referred to the effectiveness of e-cigarettes in reducing nicotine exposure.
Prof Luke Clancy, Consultant Respiratory Physician and Director General of the Tobacco-Free Research Institute Ireland (TFRI), said that e-cigarettes are recommended by some clinicians in respiratory medicine, but it is difficult to determine to what extent. Prof Clancy said doctors may also be unsure regarding the public health advice in this area.
“They haven’t been surveyed on it,” Prof Clancy told MI. “But anecdotally I don’t think they [doctors] know what to do.”
Prof Clancy said that specialists in respiratory medicine have a difficulty in this area.
“There is the question of how much damage the inhalation of the vapour does. So you want to be very careful,” Prof Clancy told MI.
“The type of rationalising is ‘well, sure if they are causing harm, it’s probably not as much harm as cigarettes’. But the retort to that is these [e-cigarettes] are not the best for smoking cessation so why are you using it instead of the best.
“So I think they [doctors in respiratory medicine] have a problem and they don’t know what to do.”
Dr Deegan from the Blackrock Clinic told MI that he did not believe there was enough clear guidance for clinicians from public health bodies like the Department of Health and the HSE regarding the use of vaping/e-cigarettes as a smoking cessation tool.
When asked whether respiratory medicine doctors are recommending e-cigarettes to patients to cease smoking, Dr Ryan from HIQA told MI: “Yes, they probably do actually. What we do know is that e-cigarettes are safer than smoking.”
Certainly the most recent academic research indicates that recommendation of e-cigarettes in a clinical setting is an international trend.
Research published in August 2016 by Oxford University Press in the Nicotine and Tobacco Research Journal found that the majority of US physicians are “discussing electronic cigarettes in clinical contexts and a substantial proportion of US physicians have recommended electronic cigarettes to their patients”.
The researchers’ survey of American doctors found that “overall, 37.9 per cent have at some point recommended electronic cigarettes to their patients that smoke”. Over 70 per cent of doctors who took part in the survey indicated that e-cigarettes could help patients reduce or eliminate smoking.
This, it should be noted, is among doctors in the United States where the attitude of the public health establishment towards e-cigarettes is generally regarded as more cautious compared to that of the UK and even Ireland.
But the lack of “consistent stance” in the message towards e-cigarettes from public health bodies is an issue for doctors. The role of e-cigarettes in clinical practice was raised as part of another recent paper published in the Annals of Internal Medicine.
The main conclusion from the paper (Nicotine, Carcinogen, and Toxin Exposure in Long-Term E-Cigarette and Nicotine Replacement Therapy Users: A Cross-sectional Study) was that e-cigarettes are less toxic and safer to use compared to conventional cigarettes.
Dr Lion Shahab, Senior Lecturer in Epidemiology and Public Health at University College London (UCL), was lead author of the paper. He told MI that clinicians are using e-cigarettes in their practice, but would benefit from greater consistency in the guidance from public health bodies on their usage.
“Current trends suggest that even smokers are starting to think that e-cigs are as dangerous as cigarettes; probably due to the amount of negative press surrounding them,” Dr Shahab told MI.
“I would think that more consistent and scientifically honest reporting may correct this going forward. You may be aware that in the UK some organisations such as Public Health England and the Royal College of Physicians are endorsing e-cigs for harm reduction whilst others like the BMA are not.
“Again, having a consistent stance based on best scientific evidence would be helpful in guiding doctors on how to integrate e-cigs into treatment as appropriate.”
Dr Shabab says that, from his research, the best scientific evidence “suggests that e-cigs are much safer than standard cigarettes”.
“I suspect that with the arrival of new harm-reduction products, like heat-not-burn products such as iQoS, the attitudes towards e-cigs will soften given that they are much closer to traditional NRT on the harm-reduction spectrum.”
A ‘watchful waiting’ approach
Investing in interventions to help people quit smoking is effective and provides good value for money, the recent HIQA HTA advised Minister for Health Simon Harris.
The HTA was the first ever analysis carried out comparing the cost-effectiveness of alternative mixes of smoking cessation interventions with an existing standard of care and the first assessment in the EU to examine the cost-effectiveness of e-cigarettes as an intervention to help people quit smoking.
The HTA recommends using varenicline either alone or in combination with NRT for smokers wishing to use some type of pharmacological support in their attempt to quit.
However, on e-cigarettes, “HIQA advises the Minister to await the results of ongoing trials before deciding whether to recommend,” said Dr Ryan.
“A decision to advocate e-cigarette use should take into consideration any additional information on the long-term safety of e-cigarette use, and any emerging data in relation to concerns about the social normalisation of e-cigarettes leading to increased uptake among people who have never smoked, or later migration to tobacco cigarettes.”
But Dr Ryan told MI that, while the evidence may be “light” at the moment, this will change very soon.
“We have had two randomised controlled trials at the moment. Those two trials combined suggest they are effective and they are twice as effective as no active treatment. It is still quite a light evidence-base I suppose.
“There are six randomised trials that are ongoing… the first of them will report towards the end of this year. So the evidence is emerging very quickly. That will allow us to conclude definitively on the effectiveness and that they are better than no active treatment.
“The first big trial will come out towards the end of this year. And all six trials are due to come out over the next three-to-four years. That should be very conclusive evidence, you would hope.
“Those trials will collect safety data as well, but it’s short-term safety data in the context of the clinical trial.
“What we are missing as well is long-term safety data. E-cigarettes are just not around that long, that is part of the issue. The other issue is that they are not a licensed medication so they are not subject to pharmacology vigilance in the same way as pharmaceutical smoking cessation aids would be.
“That said, though, the evidence around safety is emerging as well. What we have said is that we think it’s too early for the Minister to endorse them, or for the HSE to be advocating it.
“…We do concur with the HSE’s approach at the moment, which is if somebody decides themselves to use e-cigarettes to quit smoking, the HSE provides them with support, it provides them access to quit-line and counselling assistance and so on.”
Dr Ryan noted that there are public health concerns around e-cigarettes in terms of the potential for “normalisation or re-normalisation around smoking”.
Prof Clancy told MI that “if they [e-cigarettes] were as good as NRT then you would have to ask, are they as safe as NRT?”
“A lot of the debate has been about whether e-cigarettes are as safe as cigarettes or safer than cigarettes. So although we don’t know definitively, most people, including me, believe that they probably are. But that isn’t the question.
“The question is are they as safe as NRT? And are they as effective as NRT? And are they as cheap as NRT? Now the answer to those questions is unknown. Therefore, it [HIQA] rightly said this looks promising, but can’t recommend it at present.”
Prof Clancy said he also has concerns over the ownership of some e-cigarette firms by the tobacco industry.