July 24th, 2013

Why doctor doesn’t always know best

Marco Van Basten (@MarcoVanB_UK), a constituent, vaper and film maker, interviews Linda McAvan MEP, the European Parliament rapporteur for the Tobacco Products Directive.

I’ve already given a view on what an incoherent piece of regulation is emerging from the European institutions – a gargantuan dog’s breakfast, and McAvan bears some of the responsibility for that. There’s a lot in this interview and he does a good job interviewing her.  If you want to write to her having seen this, it is [email protected] if you are a Yorkshire and Humber constituent and [email protected] for everyone else. As always, be polite, persuasive, encouraging and give your own views on what you are hearing based on your experience – ask questions and ask for a reply.  If you are in the e-cig business she has some critical things to say about your motives, so there are some things you might wish to challenge in what she said.

Top doctors know everything

I want to focus on her reaction to a Lancet commentary arguing against medicines regulation for e-cigarettes. This was presented to McAvan during the interview at 10 minutes in.   She doesn’t really engage with the arguments at all but resorts to ‘argument from authority’ referring to ‘top doctors’ in the UK who see it differently.  I’ve long wondered how ‘top doctors’ anywhere manage to form authoritative views on so much outside their training and experience – it seems to be a kind of professional assurance that comes with a white coat.  To know that medicines regulation is the right approach to e-cigarettes you would need:
1. Knowledge of legal and policy principles that underpin regulation in the EU – for example, the principles of proportionality, non-discrimination, appropriate legal base, minimum burdens consistent with meeting the policy objective, adequate consultation etc and be sure these had been applied.  You might also know of the case law in which medicines regulation was struck down in four cases in the EU. You might want to know why the FDA failed in court with its attempt to regulate e-cigs as drugs.
2. A good understanding of the alternatives to medicines regulation, and what shortcomings, if any these might have and how they might be addressed other than through medicines regulation.  Also, the balance of costs and risks that these alternatives create.
3. A clear market failure based ‘case for government intervention’ and sound grasp of the type and magnitude of the risks that the regulator is required to manage, and what costs might be justifiable in managing these. At the moment it is hard to detect what is actually so wrong that it needs a draconian regulatory intervention – the only complaints are coming from non-smoking charities, pressure groups and academics, often with mixed motives that do not always involve public health.
4. Insight into the requirements and costs to the supply chain of meeting arbitrary pharmaceutical standards for ‘quality’ – ie the pharma GMP standard and other quality standards (for example could ISO 22716). These cost are revealingly not quantified in the MHRA impact assessment.  It is likely that the supply chain costs and organisational capabilities required will run to tens of millions, not the few hundred thousand often quoted, for the companies involved.
5. Grasp of the potential impact on innovation, product diversity, creativity and the likely impact that would have on the appeal of the e-cigarette category to smokers relative to cigarettes.  It’s hard to assess this but the restraint of commercial freedoms comes at a price. The cautious hand of the regulator has hardly made for competitive NRT products.
6. Some sense of what the medicines regulatory process is trying to achieve.  The regulator says that no products on the market would meet its standard, although many users express themselves very content, to say the least., with products on the market  So what is the thing that justifies the regulator intervening in trade that already exists between satisfied suppliers and users? Why is the regulator’s objective the right one?
7. Feel for the  ‘creative destruction’ economic dynamics of markets and how this raises standards, quality and innovation for the vast majority of products through the interactions of consumers and responsive suppliers in competitive markets.
8. Assessment of how the preferred regulatory regime would work in the 27 other member states and beyond, and how medicines law is applied in practice.  The UK MHRA might be relatively enlightened (‘relative’ is the word here) but the others aren’t necessarily – what effort have top doctors made to understand the consequences of handing such obstructive powers to regulators in such a politicised environment.  In the countries that have banned e-cigs, medicines regulations has been the method of choice.
9. Unintended consequences – the rise of home e-liquid mixing, internet trade etc. that may create more risks than the intended regulation avoids.
I could go on, but let me leave it at that. Not much of this experience is acquired through a career as a cardiovascular surgeon, epidemiologist or smoking cessation counsellor.  That’s not a criticism of those professions, just a reason for them to be cautious when straying authoritatively into these areas of policy.  My point is that judgements about regulatory arrangements are inherently economic in nature – like most of public policy. I worked for a regulator myself once, albeit in a different field, but we were acutely aware of the damage that excessive regulation could do.

27 comments to Why doctor doesn’t always know best

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  • I’d hoped for more professionalism from the rapporteur responsible for guiding this legislation through the European Parliament. Linda McAvan was ill informed and unconvincing.

    I do not believe that she is aware of the implications of her recommendation for ‘light touch medical regulation’.

    (1) If medical products need to prove safety and efficacy (while consumer products only have to prove safety) what efficacy benchmark will be used for a recreational product that is not intended to treat or prevent any disease?

    (2) The notion of ‘light touch’ is vague and deceptive. I’m more inclined to believe Jeremy Mean’s comment that no existing e-cig product would be allowed on the market. Article 18 of the act is Draconian, and far from ‘light touch’.

    The ENVI report was only published on Friday 30 August, and amendments need to be submitted before noon on Wednesday 4th September. Let’s encourage European Ministers to at least put forward the amendments proposed by the European Parliament’s Committee on Legal Affairs, who have had longer to consider the issues. Naturally their own additional amendments would be a plus.

    • Zillatron

      You’re right.

      Except that now it’s the (very short) time for the MEPs to come up with sensible amendments, since this is the parliament. The council, where the ministers will do their – I hope best, but fear – worst is due later.

      I don’t know if they could simply repost the most sensible amendment from the JURI opinion, since this was already ignored and discarded by ENVI.

      Anyway, for an acceptable amendment at this stage at least 40 MEPs or a whole fraction need to sign it. It’s hard enough for 3 people to agree on an issue.

      Well, I’ll watch this debate personally next monday in Strassbourgh after we presented the petition to Mr. Schulz or his representative.

      I hope I don’t have “a dog’s breakfast” listening …

  • Margaret Hermon

    A great piece Marco and, like Francis, I admired your calm – much more impressive than the waffle-woman herself. She didn’t seem to be a comfortable lady at all; wonder who’ll be left carrying the can when it all goes pear-shaped. They keep repeating the same fatuous tripe – at one point she seemed to be wanting us to have a better deal. Thanks but no thanks!

  • Hi Marco, Thank you very much for interviewing Linda MacAvan.I was very impressed by the questions you asked her and how calm you remained.. She reminds me of Thatcher and her statement ” This ladies not for turning”. She has made up her mind, and whatever is put to her she will not view it with an open mind. She is always on the defensive.

  • Hiya,

    In response to some of the above, no, Mrs McAvan had no prior knowledge of what I was going to ask her, it was not asked for or offered… ( couldn’t you tell !! )

    Given more time ( I only had 30 mins ) I would have asked much more !..

    There were many many things we could have discussed, but there was simply not enough time for everything ! :0)

    I was seeing Mrs McAvan as one of her constituents, as she is my MEP, and secondly as part of my involvement in the Vaping Community and as part of my show for VTTV..

    Cheers

    • Clive Bates

      Marco – I thought it was a very good interview. She certainly wasn’t expecting to be doorstepped with a piece from The Lancet…! It’s important in an interview that she gets to have her say and we hear her make her case to the best extent possible – then we know where she’s coming from. Her attitude to the e-cig industry and regulation was especially revealing, showing no real concern for the costs or impacts of regulation, and just dismissing concern about it as ‘well they would say that, wouldn’t they’. Words like ‘profit’, ‘private sector’, ‘business’ were used as if the meanings were pejorative and she seemed to have no qualms about imposing whatever costs she felt like on this industry – arguing that they are growing and will eventually be big enough to bear it.

  • I agree with your comment but we smokers are not lepers

    • Rachael

      @ Pat Nurse
      E. cig users are all ex. smokers and my husband smokes roll ups in the house. It’s his choice and I neither preach nor complain. Everyone is (supposedly) entitled to freedom of choice and I, like most others here, vape as an alternative to tobacco because we have chosen to for various reasons, and no one has the right to take our choice away any more than they have the right to take yours. If we were totally against smoking, as ex. smokers ourselves, we’d all be hypocrites.

  • lizzie

    I’m absolutely sick of these crusading, clueless, patronizing politicians who think they know best. It wouldn’t have mattered what anyone said to her. She thinks she’s right. She’s so wrong.

    You will have your e cigs, but you will not be allowed to enjoy them. Will she take responsibility if vapers are forced back to smoking?

  • Margaret Hermon

    Three questions I would have asked:
    Are you aware that most users of electronic cigarettes have no intention of giving up nicotine – ever?
    Are you aware that the minister, Anna Soubry, acted without reference to, consultation with or sanction of H.M. Government?
    Are you aware that the legal opinion of the E.U. committee involved is that medicalisation of electronic cigarettes would not stand up in a court of law?
    I don’t know whether an overview of the questions or general trend of the interview was required beforehand – very possibly the case. I’d love to see Paxman versus the Angel of Death – I’d crawl on my knees over broken glass for a ring-side seat! As to “standardisation” – even if all e-cigs were identical we all vape at different rates, just as we smoked at different rates so the whole thing becomes a nonsense. We regulate our own intake.

  • One regular tobacco cigarette has approximately 10-20mg of nicotine. The level displayed on the package is the amount present in the smoke when you get 2-second puffs of 35ml air, one puff every 60 seconds.

  • Thanks for the mathematical explanation. I smoke rolling tobacco and the 1.6mg is each cigarette rolled. I assumed the 4mg you spoke of would be for every e-cig consumed.

    I still stand by my comment that some smokers smoke for the smoke and not the nicotine. I enjoy, and prefer, the taste of tobacco but in hard times I have smoked tea. Should tobacco be made illegal in my lifetime I will smoke tea again.

    Should we all be forced onto prescription ecigs, I will grow my own tobacco and go underground. There are always alternatives.

    • Chris Price

      Hi Pat.

      You can forget about all these comparison figures because they assume that all the nicotine in e-liquid is transferred into the vapour. It isn’t. The current working hypothesis is about 50%. (For more data see the ECF Library.)

      In any case there are so many variables in the whole process that the mechanisms aren’t quantifiable in any case – what matters is the end user’s experience. In other words, what is the level of nicotine in your blood plasma, and is that enough for you. As an aside, vapers are generally satisfied with a blood plasma nic level from vaping that is around 40% lower than they experienced when smoking.

      And then once that is sorted out, you then have the percentage of people who will experience cravings even when given enough nic they start to OD. Many of these people need the WTAs (the other alkaloids in tobacco) and no amount of nicotine will fix that. They will fail with a regular ecig no matter how good and no matter what nic strength is supplied. They need WTA-added refill liquid, or Snus in addition.

  • Jay Gee

    @ Pat Nurse re. what’s wrong with 4mg?

    Nicotine concentration is per ml of eliquid, but 1 ml of eliquid does not equate to 1 cigarette and the absorption rates are not equal either. This is a big misconception.

    Your 1.6 tobacco ( not sure if cigarette? ) is 32mg for someone smoking 20 a day or 96 for someone on 60 a day. There is nothing/no one telling smokers how many cigarettes or how much nicotine they can take.

    The average vaper uses 12-18mg strength eliquid and consumes somewhere around 4-5ml per day. That is 48 – 90mg consumed, but not necessarily ingested. Some will use more, some less, but it’s nonsense say it’s ok to limit the level of nicotine in eliquid to 4mg when you don’t understand the basics.

    I personally vape 24mg and still don’t get the same buzz or nicotine high that I used to get from the 0.8 mg cigarettes I used to smoke.

  • Jonathan Bagley

    She wasn’t asked directly whether she thought 24mg liquid would still be available (or 54mg or 72mg mixing liquid) considering that the current version of the TPD bans liquid over 4mg. As it is practically impossible to block the supply of the hardware, it is access to inexpensive liquid of the desired strength which concerns most vapers.

  • west2

    Pat wrote:As for the nicotine content to be medicalised, then what’s wrong with 4mg? My tobacco has only 1.6mg and I have no problem with that.

    Not sure the mg in a cigarette can be directly compared to those in e-liquid. My understanding is that in the EU, for a cigarette, the limit is 1mg. So 4mg for an e-cig sounds ok, even high. It would be if 1 e-cig = 1 cigarette but it is not as simple as that.

    Some people have suggested one cart is equivalent to 20 cigarettes. This would imply, using the EU 1mg limit, that a cart would need contain at least 20mg. So 4mg, being 1/5, would mean your 1.6mg cigarette would be restricted to 0.32mg using the equivalency idea. I am sure this would not be acceptable.

    The equivalency idea is not really useful since the Nicotine content of the e-juice can affect qualitative aspects of the vape, such as throat hit. This is difficult to quantify.

    • I have oublished a study on that, involving measuring consumption in experienced e-cigarette users (but not absorption). The paper can be found here (available full-text for free): http://www.mdpi.com/1660-4601/10/6/2500

    • Jonathan Bagley

      There is an empirical formula, named after the proposer, an ecig developer called Trog, which many people find reasonably accurate. Let N=tobacco cigs smoked, S=strength of liquid in mg per ml and V=volume of liquid in ml. Then

      N=SV/3.5 or S=3.5N/V.

      For example, a 20 a day smoker using 3.5ml of liquid would require 20mg liquid. Many people settle on 3 to 4ml of liquid as giving desired vaping frequency and then choose their strength accordingly.

  • Pat Nurse

    Some smokers like me smoke for the smoke and not the nicotine hence we don’t get on with e-cigs. As for the nicotine content to be medicalised, then what’s wrong with 4mg? My tobacco has only 1.6mg and I have no problem with that.

    Probably the motivation in taking ecigs from fledgling businesses to hand over to Big Pharma, is that they are a useful tool when we are all forced onto prescription and made to queue for our repeat prescriptions of nicotine in ecigs like heroin addicts queue for morphine. That is the reason why people will turn back to tobacco – if it remains legal in my lifetime. They are legitimate consumers and do not want to be denigrated as medicalised addicts.

    Ecigs are the most effective method of quitting tobacco because they mimic the smoke of a real cigarette. They make the anti-smoker industry defunct and they can’t have that can they or they will lose their valuable funding, jobs, and Big P sponsorship.

    Education and not coercion is always the best way of turning consumers from a product that some think they have the God Given right to ruin because they don’t like it or fear it.

    • Zillatron

      Well, those 4 mg are already dead. Now they want everything regulated as medicinal product, no matter how low the nicotine content is.

      But the comparison of the 4 mg with the nicotine content of a single cig is a common misconception.

      It actually was 4 mg/ml. You must know that 1 ml produces about as much vapour as 10 cigs smoke. So you should rather compare 0.4 mg to the yield of a cig. That’s why we were so furious about it.

      I personally started vaping with 18 mg/ml liquid and that’s still the level I’m happy with. Something much lower would have me “chain vaping”. More than I like.

  • I found it interesting to watch her body language, and how she pushed the Lancet report to one side.
    What are the majority of smokers going to do when they find out that the highest nicotine available in ecigs will only be 4mg if they are medicalised. I know, they won’t even bother, and continue to smoke.
    Oh and she thinks suppliers should fork out huge amounts of money to get a licence. Most suppliers are small business’. She knows full well the only people able to afford a licence are the pharmaceutical and Tobacco companies

  • Roger Hall

    I sometimes feel that I’ve been in a coma for the past 5 years and have missed all the media articles and public outrage regarding all the deaths and harm that have already been caused by e-cigs. We keep hearing that this is all about the public’s health and that doctors need to be confident in prescribing/recommending e-cigs to people that want to give up smoking, yet I’ve not seen or heard any evidence of any real health problems – only possible, future “what if” health concerns of a dubious nature. So where is the evidence of public complaints of e-cigs? If medicine regulations are to protect the public and ease the mind of doctors wanting to prescribe e-cigs, than looking at the record of Chantix a medicine regulated NRT product then even Pharma regulated medicines cannot be guaranteed. To hear McAvan preach that medicine regulations safeguards the public is simply and factually not true.

  • Twiglet

    In the current market if a smoker bought a product with insufficient nicotine s/he would choose another product next time. No smoker could be under the impression that there is a lack of choice. If she gets her way any smoker who is dissatisfied with their first try of her ‘Nicocrapstickalike’ would simply go back to smoking, because it’ll be that or nothing.

  • Linda McAvan has her argument. She has her bag of supporters. She has her evidence. She has her concerns and her answers. Why listen?

    ‘Well I don’t know who wrote… I mean… The Lancet publishes different views… and the medical profession has been… divided to a certain extent… and some… sure I’ve met some doctors who don’t think (not from this country actually)… I don’t know who these doctors are… not from the UK… in the UK I did take soundings from people who do believe, like Action on Smoking and Health (ASH) they do believe you should have e-cigarettes on the market but their top doctors say… because they deal with people… they want them to be regulated as medicines.

    And so, yes there are some doctors who don’t think that but there are… equally in the UK if you look at the bulk of the opinion that I’ve had from the health community and from top doctors are certainly saying to me we think, to get the quality right, to make sure they do what they say on the tin, because… if these… they did all the tests… some of them didn’t have enough nicotine in them… so if somebody was a heavy smoker and choose a product with not enough nicotine, they would think it didn’t work… and go back to smoking… so there are disadvantages of having sub-standard products on the market as well.’

    Incoherent drivel but indicative of a Canute-like approach.

    Many thanks to yourself for this piece and Mark Green for the interview.

  • Just in few words, experts need to know and understand what the e-cigarette really is, how it works, why it can be (and is) successful in smoking substitution, and why nicotine medications do not work in the real world (or even in clinical studies).

    A lot of fine and respected scientists may be experts in their field but have no idea on the above. Many of them are lung physicians…

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