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  • Sally: We're here with Clive Bates, one of my most esteemed colleagues in the world of

  • e-cigarettes and vaping, and more largely, public health.

  • He is an expert in tobacco control, has worked for many years in that.

  • For a number of years, he was the head of Action on Smoking and Health, which is a public

  • health advocacy group based in London.

  • And since then, he runs this magnificent blog called The Counterfactual, and his analytics...your

  • analytic skills are just...and your knowledge...the scope of your knowledge is really amazing,

  • and you're a wonderful writer as well, so I'm so thrilled to have you here.

  • Clive: Is the whole interview gonna be like this?

  • Sally: It could be.

  • So let's talk about e-cigarettes, vaping, tobacco harm reduction.

  • Frankly, how exciting it is and the difficult time it's having in this country in becoming

  • more widespread.

  • Clive: Yeah.

  • I'm in the world of tobacco.

  • There's just been the most amazing developments in the last few years.

  • I mean, we have ongoing, essentially, a technology-based disruption of what is a huge and stable entrenched

  • industry.

  • So the tobacco industry is about $800 billion worldwide.

  • So it's a huge industry selling about six trillion cigarettes to around just about 1.3

  • billion smokers, okay?

  • Massively profitable, and its profitability has been rising over the last decade.

  • You know, people in our business, tobacco control, often think we're winning, but if

  • you measure it by the profitability of the companies, we're definitely not winning.

  • So along comes a new technology.

  • Essentially, developments in batteries mean that you can now heat a liquid, create a vapor

  • aerosol, it will deliver nicotine to the lungs in a way that many smokers find satisfactory

  • without all the stuff that goes with setting fire to tobacco leaf and inhaling it.

  • And it's that products of combustion of organic leaves that do all the damage associated with

  • smoking.

  • So the experts in the UK have assessed the evidence, and they would say that e-cigarettes,

  • vapor products, are likely to be at least 95% less risky than smoking, and probably

  • a lot lower than that even, just based on the toxicology of what's in the vapor.

  • And in that understanding, that is the most amazing potential for a public health breakthrough

  • in the United States, in Europe, and worldwide.

  • Sally: Right.

  • Actually, this is something we can come back to, but it's so fascinating how your country

  • is so progressive on this product, which is referred to as...the FDA, by electronic nicotine

  • delivery...

  • Clive: Delivery systems.

  • Sally: ...systems.

  • ENDS.

  • Also known as vaping, e-cigarettes, and which are now in their third and fourth generation

  • of devices, let's say, can deliver nicotine more efficiently, but still not as good as

  • the actual product.

  • Clive: I think we got off to...we didn't get off to the greatest start in the UK.

  • The instinct was to use a illness treatment cure model.

  • You know, smoking's the illness.

  • You need a treatment like a drug or a nicotine replacement therapy and then you will be cured.

  • And what they did was conceive of these things as a treatment, like nicotine replacement

  • therapy, or Chantix, or one of those medical things, in which the medical profession intervenes

  • to give a smoker a medical thing that cures them of smoking.

  • Of course, that's not what it is.

  • Most of the smokers who are switching to vaping don't see it in that way at all.

  • They don't classify themselves as patients.

  • They don't think they're taking a medicine, and they don't go to treatment settings to

  • get it.

  • Sally: They're true consumers.

  • Clive: They're making a consumer choice, so it's a little bit like somebody who decides

  • they're gonna get a bit fat and they're gonna switch from full sugar Coke to Diet Coke or

  • something like that.

  • And they're making a consumer choice that has a collateral health benefit, and that's

  • one of the reasons why they are doing it.

  • And it's all going on in the marketplace.

  • Medical professionals are not really involved or haven't been that much.

  • Many of them have set themselves against it, in fact.

  • There's no public spending involved.

  • Taxpayers are not harmed.

  • No one has asked the public health community for their permission to do this.

  • These products have emerged from innovators on the market.

  • Consumers have voluntarily started to use them and become experts in them.

  • Sally: Right.

  • Why are they so attracted to them?

  • What are the virtues that they say?

  • Clive: It's fascinating because I think what they do is they replicate the value that smokers

  • find in smoking, which is a number of things.

  • It's several things at once.

  • It's a delivery of nicotine in a way that provides a meaningful physiological effect,

  • you know, a buzz.

  • It replicates some of the throat effects.

  • It provides taste.

  • It provides warmth.

  • It provides something to have in the hands, behavioral ritual, something that fills rituals

  • that happen at certain times of day, you know, having the coffee and morning croissant or reading

  • the newspaper, that kind of thing.

  • So it drops into the same place in life that cigarettes are, but it doesn't have all the

  • disadvantages, like, you know, cancer, heart disease, respiratory illness.

  • That's not to say it's completely safe, but nevertheless, those things are taken out probably

  • quite a bit cheaper as well as a habit to pursue.

  • Then it has a whole load of other things, sort of there for the geekiness.

  • You know, people like the technology.

  • It's high degree of personalization involved, so people can configure the devices and the

  • liquids that they use to exactly what they want, and they can change those according

  • to their mood, the time of day.

  • They can progress through different types of products over time.

  • So what it does, it sets up an alternative value proposition to smoking that many smokers

  • find attractive, even if it's not a complete substitute.

  • Taking everything into account, it works out a better deal for them and they go with it.

  • Sally: So I'm going to pose to you the kinds of objections that at least our public health

  • community, not everyone, I mean, there are some folks who are responsive to data, but

  • there is a lot of ideology driving the resistance, and I'm gonna name the four basic arguments

  • against it.

  • One is that it normalizes smoking.

  • A lot of this concern surrounds the children.

  • It normalizes smoking, it will be a gateway to smoking.

  • Dual use, in other words, continuing to smoke while you vape is not a good idea, and nicotine

  • is dangerous.

  • Clive: Okay.

  • Okay, so renormalizing smoking, it's never been that obvious to me why the emergence

  • of an alternative technology to smoking somehow normalizes smoking.

  • Surely, what it does is normalize the alternative behavior, which is giving up smoking by switching

  • to vaping.

  • No one does ever provide any compelling evidence that this is actually this bizarre thing.

  • When you think about it, it's a bizarre claim that you launch a new product and actually

  • what it does is increase sales and use of the old product.

  • It doesn't do that.

  • It does exactly the opposite, and there's no evidence to support it.

  • It's just a made-up argument that has no basis in reality, and to be honest, it doesn't really

  • have any basis in plausibility.

  • Adverts for e-cigarettes, marketing of e-cigarettes market e-cigarettes.

  • They market an alternative.

  • Sally: Gateway?

  • Clive: Gateway effect.

  • First of all, there are the people who talk about the gateway effect.

  • When you actually say, "Well, what exactly do you mean by a gateway effect?"

  • What you'll get is some slightly confused or very confused, often, things about, "Well,

  • they started on e-cigarettes and then they went to cigarettes, okay?

  • And that means the e-cigarettes were a gateway."

  • It doesn't mean that at all.

  • To understand whether there was a gateway, what you have to do is imagine a world without

  • e-cigarettes and look at all patterns of smoking there would be.

  • So some people never smoke, some people would smoke.

  • And then you introduce e-cigarettes into that world and those pathways all change.

  • So some people who smoke would switch to e-cigarettes and then maybe quit completely, and that's

  • a gateway exit.

  • That's a good gateway.

  • Those are the gateways we want.

  • So then you have to find...to find a really harmful gateway, you have to find someone

  • who would never have smoked, and bare in mind, it's hard to know that.

  • They have to then switch to e-cigarettes, which does them a bit of harm that they wouldn't

  • have done to themselves otherwise.

  • And then they have to move on and graduate to the big harm, which is smoking.

  • So finding people that have gone down that pathway is extremely difficult.

  • No one can really produce the people that have done that.

  • None of the studies really do show that, and none of them are set up to do that kind of

  • follow-up work or to measure people as they progress through these things.

  • So what happens is that people overclaim on gateway effects.

  • They find associations between vaping and smoking and then they conclude that the vaping

  • is causing the smoking.

  • What is much more likely, though, is that the same things that incline people to smoke

  • are the same things that incline them to vape.

  • In other words, there are same personality characteristics that cause the two things

  • to happen.

  • And if they take up vaping and they would have otherwise smoked, it's a benefit to them.

  • So I don't think there's anything in the gateway effect, and when the Royal College of Physicians

  • look to this, and Public Health England, they said, "First of all, the concept's so woolily

  • defined, it shouldn't even be used."

  • And certainly, there's no evidence to suggest that's happening on a meaningful scale.

  • Sally: Yeah, and the epidemiology certainly bears that out in that there are fewer and

  • fewer teens who are smoking.

  • So if there were...

  • That's the big story.

  • If there was a gateway effect, where are all the people who are emerging the other side

  • of the gate?

  • Sally: Right, exactly.

  • Clive: You know, they're not there.

  • In fact, teenage smoking is falling to the lowest levels and at the fastest rate in history,

  • coinciding with the rise of vaping.

  • So it suggests that if there's a gateway, it's an exit, not an entry to smoking.

  • The other one was dual use.

  • Clive: Okay.

  • So dual use, it's odd that people think that dual use is a bad thing.

  • If somebody starts using a different product instead of smoking, there are a number of

  • good things that could come out of that.

  • First of all, if they carry on, then their risk is likely to be reduced.

  • Some of the health effects of smoking are proportional to exposure.

  • And therefore, if you reduce your exposure...

  • Sally: You have the respiratory effects.

  • Clive: Yeah, exactly.

  • And actually, cancer effects as well.

  • Sally: But the cardiovascular, we're not so sure.

  • Clive: Cardiovascular, there's some doubt about where there's non-linear effects and

  • so on, so there may not such a benefit there.

  • But hell, respiratory cancer, that's something.

  • Sally: That's huge.

  • Clive: Then it's the argument that actually many...you have to look at this dynamically.

  • So if you just take a snapshot, you may be missing the fact that people are on a lengthy

  • transition.

  • They're going from being 100% smokers and they're gradually shifting through dual use

  • to not smoking at all, or smoking on an occasional basis.

  • And then the final thing I think to say about dual use is it's not one thing.

  • You know, somebody who vapes all the time and then smokes a bit at the weekend when

  • they've had a few drinks, they're not at particular risk.

  • Occasional smoking isn't a big deal.

  • It's daily smoking that you need to worry about.

  • And of course, they are very different to somebody who smokes all the time and vapes

  • every now when, you know, they're not allowed to smoke.

  • So those are two people who would both be classified as dual users, but their pattern

  • of use is completely different, that it's meaningless to lump them together in a single

  • category.

  • So you need to dive into the data to understand what's going with dual use, but it's definitely

  • not a bad thing.

  • It's only goodness comes from dual use, no badness.

  • Sally: Nicotine?

  • Clive: Well, nicotine has been studied extensively for many, many years in a way in which it's

  • consumed separate to smoking.

  • So nicotine replacement therapy patches and gums and smokeless tobacco, Snus, for example.

  • It's pretty clear that nicotine is not the harmful agent.

  • It's not completely benign, but then caffeine isn't completely benign either.

  • Nicotine does have some effects on the body, so, you know, it changes pulse rate.

  • It has effects on the cardiovascular system.

  • And what people have been doing is they'd been measuring those effects and going, "Oh,

  • look, something bad is happening."

  • But actually, that's normal.

  • Those bad things happen when people take caffeine, when people go running, when people listen

  • to rock music.

  • You see physiological responses to these things, but they don't necessarily lead to people

  • keeling over dead with heart attacks and strokes in the future.

  • Sally: And they tend not...in many of these studies that look at the effects of vaping,

  • they don't compare them to cigarettes because the whole keyword here is "relative."

  • Clive: Well, the Surgeon General did a very exhaustive review of the health effects of

  • smoking, and the conclusion of that was that the things that cause cardiovascular disease

  • in nicotine is the products of combustion like carbon monoxide, oxides of nitrogen.

  • They're just not present in e-cigarettes because there's no combustion.

  • So I think they're trying to argue that nicotine is a harmful agent because it's integral to

  • the product.

  • You obviously can't take it out or it's no longer a substitute, but we've never heard

  • in the past about passive nicotine exposure.

  • We've never really had the emphasis on nicotine as the harmful agent until now.

  • And the truth is it's not completely benign.

  • There may be issues for pregnant women or for teenagers, but in all circumstances, it's

  • better to take nicotine from an e-cigarette than nicotine from a cigarette.

  • Absolutely no question.

  • Whether you're pregnant, whether you're four years old.

  • That is always an improvement.

  • Sally: Right.

  • And I'm just gonna add one more, which is flavors.

  • That's a big issue.

  • It's a way to lure children.

  • Clive: Yeah.

  • Flavors have been seen as the problem issue.

  • Of course, people say, "Well, just ban flavors."

  • Well, if you're gonna ban flavors, you're banning the product because all e-cigarettes

  • use flavors of one form or another.

  • Sometimes it's a tobacco flavor, but it's still a flavoring, okay?

  • Now, the flavors argument is quite complicated, I think.

  • First of all, you'll see people that will say, "Ah, gummy bear.

  • That must be designed to appeal to kids."

  • It's not appealed to any kids that I know.

  • The adolescents that are vaping actually are trying to do what adolescents normally do,

  • which is try to look like adults.

  • They're not trying to do things that reinforce their childishness, which is what things like

  • gummy bear do.

  • Most people using those sort of products are adults wanting a kind of retro feel.

  • They're wanting to sort of, you know, remember their childhood or whatever.

  • The second thing to say about flavors is supposing they were a...sorry.

  • The second thing to say is they are very, very important in the appeal to adults.

  • They are absolutely essential.

  • And if you're gonna give up on flavors, you're basically going to be making the products

  • less appealing to adults, which means fewer will switch and more will relapse.

  • So there is a major price to pay if you're going to do something about flavors because

  • that's integral to the value proposition.

  • So then you have to determine how harmful are flavors when it comes to young people.

  • First of all, there's very little evidence that flavors are actually causing kids to

  • vape at all.

  • They have preferences for flavors, but it's not clear that it's the reason why they start

  • vaping.

  • But even if it was, most of the kids who are vaping are people who would otherwise smoke

  • or are already smokers.

  • If flavors attract them into vaping, it may even be a good thing.

  • Now, that's an argument you never hear reflected on in the United States.

  • You know, attracting people to vaping when they would otherwise smoke is a good thing.

  • I'm not suggesting that, you know, you should just go around willy-nilly trying to track

  • kids to vaping, but there are public health consequences with banning flavors that would

  • tend to increase the amount of smoking that goes on.

  • And the number of non-smokers that are attracted by flavors into vaping and then smoking, tiny.

  • You can't find them.

  • Sally: Okay.

  • So we have a product that is much safer than cigarettes, much less dangerous than cigarettes,

  • estimated as 95% less risk by the Royal College of Physicians, Public Health England, which

  • is the equivalent of our CDC here, from which you would never hear such a message.

  • In the short-term, people experience respiratory...who have respiratory illnesses like asthma or

  • COPD actually do better.

  • The gateway is going down.

  • Granted, we can't say what certainty.

  • There's a causal relationship, but at least it suppresses one of the bigger arguments

  • against it.

  • In fact, the one that, again, the CDC is most concerned about.

  • There may be some long-term consequences of inhaling what's called propylene glycol for

  • 20 years, although the consequences have not emerged yet.

  • Clive: And if they do, you can do something about them.

  • The point is unlike combustion, which is essentially an uncontrolled reaction and you can't really

  • control the chemistry of what's in smoke once you've had set fire to the tobacco leaf, you

  • can actually control what's in vapor because you determine what goes into it by what you

  • put in.

  • So if problems do emerge, it's a much controllable, much more stable product to engineer your

  • way out of difficulty.

  • So even if ill effects do start to emerge, the chance that you can do something about

  • them before they become of sort of epidemic proportions is much greater.

  • Sally: And finally, the risk of cancer would decline precipitously.

  • This is something that it will take time, so we haven't seen that yet.

  • So all these virtues, what's the problem, at least in the United States, and in much

  • of the world, actually, in terms of disseminating accurate information about that and uptake

  • of these devices?

  • Clive: Well, I think it's a really interesting question.

  • These aren't disruptive technologies, and it's not just the tobacco market that's being

  • disrupted.

  • I mean, there is a...if you like a business model in tobacco control, that is also being

  • disrupted, okay?

  • And that disruption is probably quite painful for people who have spent their entire working

  • lives fighting corporations, trying to persuade people to quit, trying to, you know, fight

  • for clean air and all of this sort of thing.

  • So I think it's something that has broken into that paradigm and hasn't been well-received.

  • So it's been defined...vaping and these new products have been defined as a threat rather

  • than an opportunity.

  • It's given them, in some ways, a new lease of life.

  • Sally: Turning over a new leaf?

  • Clive: Yeah, sort of.

  • It's turned them into, you know, the, "Oh, at last, there's something new to fight against.

  • At last, the corporations...we're getting a bit bored with taxes and advertising bans.

  • Here's something new come along that we can kind of renew our business model and we can,

  • you know, redouble our efforts against the sort of corporate tyrants."

  • I do think there are a number of things.

  • I think there's a doctorly thing, which says, "I'm telling you the best thing to do is quit

  • and you should quit.

  • I'm the authority here and that's my advice."

  • And people confuse what they want and think is right with what is the right thing to persuade

  • somebody or to help somebody reduce their own risk given their preferences.

  • There's another thing, which I think is kind of anti-corporate instinct.

  • People are very distrustful of corporations.

  • You just assume that they are venal and predatory, even though most of the world runs on corporations

  • quite successfully.

  • Sally: That sentiment is really concentrated in schools of public health.

  • Clive: Totally, yeah.

  • I agree with you.

  • I think there's...I think there's...how should I put this?

  • I think there's just a strong sort of moralistic tendency that just says, you know, "These

  • are impure things to do to yourself."

  • You know, they'll just say, "No, abstinence only.

  • We are not going to give up on the purity of our ideas just because a technology has

  • come along that people like that reduce their disease."

  • And that gets into a confusion about objectives.

  • Are you trying to deal with cancer, heart disease, and respiratory illnesses?

  • Are you trying to stop people smoking?

  • Are you trying to stop people using nicotine?

  • Are you trying to stop people using tobacco?

  • Are you trying to stop kids taking it up, or are you trying to destroy the tobacco industry?

  • Now, one time, all of those basically were roughly the...

  • Sally: The same thing, yeah.

  • Clive: They were roughly aligned with each other.

  • You were just fighting cigarettes and you could fight that battle at all levels.

  • But when you have radical differences in risk within the tobacco products and nicotine recreational

  • products on the market, you start to force trade-offs between those objectives, which

  • they have not actually acknowledged.

  • And I think if you are a nicotine prohibitionist, you end up giving up on these harm-reduction

  • options, which leave people using nicotine, but at very much lower risk to themselves.

  • Sally: Right.

  • Well, that was an excellent summary of the mindset.

  • At least there's one strain of thought in the anti-tobacco community, I would say, and

  • which must be one that is motivated in large part by its anti-corporate animus.

  • Because if you're worried about impurities, if you're worried about...or if you're such

  • an absolutist that you won't engage in trade-offs, then how does anyone explain the fact that

  • so many in public health are all for harm reduction for heroin use, needle exchange,

  • methadone, injection rooms, frankly, even possibly distributing free heroin while they're

  • against harm reduction for nicotine?

  • That's a tough one.

  • Clive: Okay.

  • So I think there's two things about it.

  • And you're quite right, a lot of public health...actually public health agencies sound quite sane when

  • they talk about harm reduction for illicit drugs.

  • And I think it's partly because there are no branded corporations.

  • There are of course very large corporations involved in the drugs trade, but they're,

  • you know, some criminal enterprises.

  • So there are no branded legitimate corporations involved.

  • But also, I think there's a different paradigm, and I think it comes back to this people talk

  • about drug treatment, okay?

  • So you are given a treatment.

  • You go into methadone.

  • Of course, there's a supervisor.

  • You're given a prescription or you're given a treatment, and then the idea is that it

  • will sort of cure you.

  • And there's an element of control over that process.

  • Sally: Actually, though, I'm gonna challenge that.

  • It's not that it's wrong.

  • Again, that applies in some domains, but the new thing is in...well, actually, it's the

  • European model, there's nothing new about it, but bringing it to the U.S. is fairly

  • new.

  • In fact, the phrase is, "Meeting people where they're at," and that is extremely hands-off.

  • In fact, there are some programs, I think they're mostly on the West Coast, which are

  • happy to follow people who have drug problems around for months and years, providing them

  • with housing and other things, but never making a demand that they get clean.

  • Clive: Okay.

  • Well, you know, I mean, that's maybe a good development.

  • I think it probably is.

  • I think you should meet people where they're at.

  • We're trying to help people, not, you know, change them into something they're not.

  • Sally: Yeah, it can be.

  • Some of them are actually about to overdose, but that's a different issue.

  • I would be a little bit weary of essentially if you're, like, endorsing damaging patterns

  • of behavior.

  • You're trying to help people.

  • Sally: Right.

  • Clive: But the key thing is that you do that in an enabling way.

  • Sally: We do that to engage them, I realized that, but some people are not too readily

  • engaged, but that's a different...

  • Clive: I think the market dynamics are really important here because what's happening is

  • as we've...smokeless tobacco, which has very significant harm reduction properties, this

  • is all going on in transactions happening between consumers and companies without anyone

  • from the public sector being involved.

  • And in fact, usually in the teeth of opposition from them.

  • And it's the fact that they're cut out of this relationship.

  • It's not the same, really, with drug treatment, but there's still a service being provided

  • there.

  • But the fact that it's going on in the marketplace is I think what they find unnerving, and they

  • almost can't believe it's right.

  • I also think that I'm speculating now, but I'm going to chuck this one in, anyway.

  • I think that people in...there are certain type of people in tobacco control who think

  • that giving up smoking should be a kind of purgative ritual.

  • That it should be a price.

  • There should be a price to it.

  • It should be difficult.

  • It should require support.

  • It shouldn't be something you find pleasurable, which is...you know, and the whole debate

  • about pleasure in smoking, you will always hear the reason people smoke is they're addicted,

  • not because they like it, except if you listen to smokers who say they like it.

  • And I think there's an analog in that in diabetes where there's actually quite a push against

  • gastric bands, for example, as if it's a source of illegitimate shortcut for, you know,

  • doing the right thing personally, which is eating a more modest diet and taking more

  • exercise.

  • Sally: Then let's move on to the FDA.

  • Last April, it issued deeming regulations which officially put electronic nicotine delivery

  • devices under the umbrella of the FDA.

  • And in the course of doing so...well, that's what I'm...I'll throw that to you.

  • What has the FDA proposed, or enforcing, I should say?

  • Clive: With any regulation, your starting point should be what is the problem to which

  • this regulation is the solution, or what is the risk to which this regulation is the mitigation

  • response?

  • And the problem for the FDA is that there isn't actually very much wrong.

  • In fact, there's a lot right.

  • So we've seen...there's now eight and a half...there's about 38 million smokers in the U.S., about

  • 8 and a half million vapers, and about 2 and a half million of them are people who no longer

  • smoke, okay?

  • So that's now a large-scale phenomenon relative to smoking, around quarter of the kind of

  • size, if you like.

  • But there's nothing really going wrong.

  • Most people who do it are quite happy about it or they wouldn't be doing it.

  • No one's making them doing it.

  • Many people have stopped smoking.

  • Many people are getting short-term benefits from it.

  • Smoking prevalence amongst adults is a record low, and falling rapidly.

  • Smoking prevalence among teenagers, it's a record low and has been falling rapidly.

  • You know, what's not to like?

  • What is the problem?

  • So what we get then is the hunt for the problem, and we see FDA spending a fortune on academic

  • studies.

  • We see CDC getting in alongside, problematizing the issue, okay?

  • So you'll see studies and you'll see talks about flavors, gateway effects, you know,

  • additives, and so on.

  • All of these things are essentially designed to create a sense of alarm that justifies

  • a regulatory intervention.

  • And one of the really terrible consequences of that is the misalignment of perceptions

  • of risk in the American public between what is real about e-cigarettes and what they think.

  • And roughly speaking, I think it's just over 5% of Americans would say e-cigarettes are

  • much less harmful than cigarettes, which is the right answer.

  • It can only be that answer.

  • Thirty-seven percent say the same or worse, and another 36% say, "I don't know."

  • Sally: And that perception has been changing over the last few years in the direction of

  • more ignorance.

  • Clive: In the wrong direction.

  • which is amazing.

  • So, to me, I mean, this is why Public Health England, Royal College of Physicians had come

  • out and been so clear about giving people an anchor, quantified anchor, you know, at

  • least 95% lower risk, so that it cuts through all the stuff that you're seeing in the newspapers

  • that's very alarmist.

  • They say, "Well, no, if you put it context, it's all very, very much lower."

  • And I think that is a piece of collateral damage that has been done to the American

  • public by these agencies as they've tried to justify regulation, okay?

  • So next, we look at the regulation that they're actually proposing, which is...I mean, when

  • people ask me, "Is there anything good about the EU regulation?"

  • I say, "No, the only good thing is it's not the FDA, okay?"

  • And that is the only good thing you can say about it.

  • The FDA's regulation has a number of totally terrible features to it.

  • It's incredibly burdensome.

  • That's the big thing.

  • Very, very expensive, and it's very, very broadly applied to literally thousands of

  • products, product components, product variance, all need this full-scale authorization with

  • full justification to the FDA, repeated endlessly over and over again for roughly the same products

  • between companies within companies.

  • It's so massively wasteful, it's off the scale.

  • The second really negative feature of their regulation is you don't know what it takes

  • to be successful.

  • With the EU regulation, it's quite burdensome, but you do know that if you do the things

  • that are required, you can put your product on the market.

  • You know that with certainty that if you comply with quite clear regulations, it's on the

  • market, no problem.

  • With the FDA, they have to decide.

  • Somebody makes a decision to authorize your product and you don't know.

  • And this is the killer.

  • You don't know what their criteria are and how they will judge the evidence that you

  • put forward, what hurdle, evidential hurdles they want you to cross.

  • You cannot tell that in advance.

  • So that makes it harder for the companies who aren't giant tobacco companies to raise

  • the finance to...

  • Sally: Who can't even afford to...this application process.

  • Clive: Yeah.

  • Can they afford it in the first place?

  • They don't really know what the cost are going to be or how long it will take.

  • So how does that play into their financing?

  • Because it looks like a giant regulatory risk.

  • So many of them don't have particularly strong balance sheets, so they're looking to external

  • finance and refinancing their operations, and their investors go, "Well, this doesn't

  • look good, guys."

  • And we've already seen NJOY go down for that reason, or that and amongst other reasons.

  • So I think it's very harmful, and there's arguments like, "Well, will it take out 90%

  • of the market?

  • Or will it be 99% of the market?"

  • We shouldn't be having an argument about that.

  • You would be taking out 90% of something that is basically quite successful.

  • You know, large number of users, lowest-ever smoking rates.

  • Everybody's happy, and yet you think it's a good intervention to take out 90% of what's

  • driving that marketplace.

  • How can that be right?

  • They haven't assessed the likely unintended consequences that will flow from that intervention.

  • And it doesn't mean...it doesn't need that many extra smokers before you've got a detriment

  • that hugely outweighs any conceivable benefit from these regulations.

  • Sally: So what are the avenues of redress look like from the congressional legislative

  • standpoint?

  • And then we'll get into the other standpoint, which is the courts.

  • Clive: Yeah.

  • Well, I mean, the issue...I mean, there's two ways out of this.

  • There's a sort of legislative fix, which would essentially treat e-cigarettes now in the

  • same way that cigarettes, which we treated in 2009, which basically is if they're already

  • on the market, they can stay on the market, okay?

  • There's a fix in the legislation called moving the predicate date, which means if you're

  • on the market at this date, then you stay on the market and you only have to apply for

  • these burdensome applications if you do something completely new, okay?

  • That doesn't solve the problem totally, but it gives respite and would end the apocalyptic

  • emergency that the FDA is about to visit on that industry.

  • It would stop that and give time to put a sensible regulatory framework in place, okay?

  • And the difficulty with that is that the democrat side, moratory side, has been sold on the

  • idea that this is a get-out-of-jail-free card and that this would allow rogue traders, you

  • know, to go out and hook kids and everything.

  • So all the nonsense public health arguments are being played into trying to stop this

  • and make sure the apocalyptic regulatory intervention that the FDA has in mind goes ahead and destroys

  • the industry and leaves only the tobacco industry standing.

  • Why they want that is a mystery to me, but that will be the effect, even if it wasn't

  • the intent.

  • Sally: And is there any...do you think there's any possibility that the Tobacco Control Act

  • of 2009 could be amended to perhaps make ENDS a different category so that it's not true

  • to this...

  • Clive: Well, there's several ways of dealing with it.

  • I mean, the first thing is you've gotta stop the emergency and that means you've got to

  • have these products stay on the market.

  • You can't just take products that are being used by eight and a half million people off

  • the market and say, "Well, you'll just use the ones that we're allowing."

  • And there might be like six of them instead of tens of thousands of what are out there

  • now.

  • That's that very first thing.

  • Stop the huge blow to the marketplace.

  • Then you've got time to think about what the right regulatory strategy is for these products.

  • And there are two ways of approaching that.

  • One is to use provisions in the existing legislation for standard setting.

  • So instead of saying, "We will authorize each product on a case-by-case basis," you say,

  • "We will set these standards for, you know, chemical safety, thermal safety, electrical

  • safety, mechanical safety, and we'll publish those standards.

  • And if you meet those standards, then zoom...

  • Sally: And that's more like the UK approach, right?

  • Clive: Well, UK uses the EU approach, but it's more like the approach...the EU approach.

  • It's more like the approach that's used for just about everything else.

  • Most products do not go...that go onto the market anywhere in the world do not go through

  • an authorization process.

  • They go on the market because they meet standards that have been defined in legislation and

  • regulations, you know, safety standards, whatever.

  • And they're allowed on the market if they meet those standards.

  • And that's the normal way of doing things.

  • It's only that we've gotten confused here with medicines and all that, that we've ended

  • up trying to do an authorization regime, which is sort of like trying to recreate the medicine

  • approval route for what is basically a consumer product.

  • Sally: Exactly.

  • In fact, I just heard Mitch Zeller, who's the head of the Center for Tobacco Products

  • at FDA, I heard him give a taped presentation at a meeting last week.

  • And he said we have...

  • "This is a common thing and it's frankly maddening.

  • We have no proof that e-cigarettes or vaping products help people quit."

  • And you knew in the back of his mind that was code for, "There aren't enough randomized

  • controlled studies."

  • And while I'm not...I hope they will come out, in fact, 12 are underway right now and

  • I'd be stunned if my hypothesis was not...or my null hypothesis was not rejected, which

  • is to say that vaping devices were not more effective than patches and gums.

  • But is that approach even...is meaningful for these products?

  • Clive: No.

  • It's a complete misunderstanding, okay?

  • I mean, it's back to this illness treatment cure paradigm in which you...you know, it's

  • the thinking, "Somebody's sick, give them a pill.

  • The pill makes them better, and bang, you can measure that."

  • You can measure that very well with a randomized controlled trial.

  • You give some people the pill...

  • Sally: Yeah, because the doctor is making the decision, as opposed to the consumer.

  • Clive: Yeah.

  • That's right.

  • So, you know, you give them the pill, you give someone else a placebo, and more or less,

  • you know that the people in the treatment arm, if they get a lot better or more than

  • better than that game on, fine.

  • Okay, that's good for assessing that kind of thing, or non-medical interventions.

  • You make one change.

  • You use a different method to teach reading, and you find that literacy rates are higher

  • in a classroom.

  • Fine.

  • As again, another subject for a randomized controlled trial.

  • The problem with vaping is that it's a change happening within a very complicated behavioral

  • ecosystem, okay?

  • So I'll just give you an example.

  • The efficacy of vaping could...or vaping devices could fall because there was a bad newspaper

  • article saying, "Vaping causes harm."

  • Okay?

  • And then people go, "Well, I don't want to do that then, so I'll give up."

  • Now, it doesn't mean that the vaping device has changed, but it means external behavioral

  • influences play a significant role.

  • You also have things like learning, so people will migrate through many devices.

  • They'll have a period of experimentation.

  • The way that they're using the products will change overtime.

  • The time for transition might be much longer than the typical length of a randomized controlled

  • trial.

  • And then finally, your point is if 80% of people would like to try vaping as an alternative

  • to smoking, and only 5% would like to try one of these antidepressant medications as

  • an alternative to smoking, that's a significant difference that is captured in a randomized

  • controlled trial because everybody gets the treatment or not.

  • Sally: Right.

  • And especially since so many...in the real world, in terms of ecological validity, so

  • many people approach vaping after they failed everything else.

  • Clive: There's that.

  • So the people who want to try...and they may not even want to quit smoking.

  • I mean, a lot of people are coming at this thinking, "Well, I smoke, but I'll try these

  • because it might be different."

  • It's like trying a different brand.

  • Or, "I could use these at a time when it suites me, or actually I think this is quite nice.

  • You know, I'm feeling a bit better."

  • So they don't necessarily conceptualize themselves as quitting.

  • They conceptualize themselves as getting the pleasures from smoking in a different way

  • with less harm.

  • That's a different mindset.

  • Sally: And that's why ethnographic research is so important here, how people really use

  • these things in the world.

  • Clive: I think so, and nowhere in the world.

  • We have quite detailed data in the UK now, but we still ask fairly crude questions.

  • We still...

  • "Are you a smoker?

  • Are you a vaper?

  • Have you tried to quit?"

  • Well, yeah, I sort of tried to quit, but I didn't try to quit nicotine.

  • I tried to smoke in a different way without...

  • What's going on in people's minds doesn't lend itself to the survey techniques that

  • we used for measuring what was happening with smoking and quitting.

  • Sally: So let's get onto that, the second option you said, which is through a legal one.

  • Clive: Yeah.

  • So the FDA has been challenged in court by Nicopure Labs and the Right to be Smoke-Free

  • Coalition on the basis that there are aspects of the way it went about making this regulation

  • the deeming rule that are unlawful, okay?

  • So it's just a form of judicial review of the FDA's conduct.

  • I think it's under the administrative practices act, Procedures Act.

  • It's one of those things, anyway.

  • Now, they are alleging, first of all, that FDA has massively extended the scope of its

  • deeming rule compared to what it's allowed to do under the act.

  • So the act defines tobacco products as anything made of or derived from tobacco.

  • But the deeming rule includes things like devices that are made of...and devices made

  • of stainless steel, batteries, software.

  • All of these things are defined as tobacco products in the deeming rule, and therefore

  • have come under this pre-market tobacco authorization regime.

  • And it would be very difficult for the FDA if they didn't do that.

  • But what they're arguing is that, unfortunately, the act doesn't give them the power to do

  • that.

  • It's only tobacco products, products that are made or derived from tobacco designed

  • for human consumption.

  • People don't consume big vaping devices.

  • So that's one ground.

  • The other ground is that essentially FDA hasn't properly...has overstated the benefits and

  • understated the costs.

  • In other words, its cost benefits analysis is inadequate to justify the regulation.

  • I agree really strongly with their analysis on that.

  • They have hopelessly underestimated that.

  • The only reason the costs are so low in the FDA, it's a paradox in a way, is the burdens

  • are so high, it wipes out loads of the companies so they never have to do the paperwork.

  • It's a really bizarre paradox in a sense.

  • You make the demand so great that no one even contemplates taking them on.

  • And then the final thing, I think, is a sort of invasion of free speech, The First Amendment

  • kind of provisions, in which they alleged that the FDA is stopping them communicating

  • properly with consumers, stopping them saying truthful and non-misleading things about the

  • product.

  • Sally: About the relative safety?

  • Clive: Yeah.

  • I mean...or just factual things like it contains no tar.

  • It does not produce ash, no smoke, you know.

  • These are factual characteristics of the products which they think would be banned under the

  • rule, or they would need to get some special approval for.

  • So truthful and non-misleading statements and provision of samples, which are regarded

  • also as a form of free speech.

  • So that's basically the case in a nutshell.

  • I mean, it looks very strong to me, but this is an area where, you know, lawyers have a

  • field day and sometimes the courts act politically.

  • Sally: Well, one of the things strengthening it is you're a brilliant amicus that, at full

  • disclosure, I did sign onto that.

  • Clive: You did?

  • Yes.

  • No, it's great.

  • So we got about 15 experts, which you're one, to sign up to an amicus brief, which is a

  • submission to the court that developed some of the points of legal arguments for the benefit

  • of the court, for the benefit of the judge to widen out her reading.

  • And so, we took criticism off the cost benefits analysis.

  • We made the case that nothing much is going wrong and therefore FDA is putting in jeopardy

  • things that are going right.

  • We made the argument that they'd overstated the benefits because the things that they

  • were claiming weren't really benefits or already done at state level.

  • And that they grossly underestimated the risks of unintended consequences.

  • And that were there any, and even if they were very small, they would completely dominate

  • any benefits that would arise from that regulation.

  • So you only need a small number of people relapsing to smoking or not quitting.

  • And because of the high value placed on life in these cost-benefit analyses, essentially

  • the whole cost-benefit analysis is blown apart, and they have not done any sensitivity analysis

  • on that, and they've not recognized that those are quite realistic dangers.

  • Sally: Right.

  • So if availability and innovation were suppressed, that could lead to more death.

  • Clive: Yeah.

  • If the consequence of taking 90% of the market out, reducing the piece of innovation, greatly

  • reducing the diversity and personalization means that there are more smokers than there

  • otherwise have been.

  • That's a detriment that you ought to count in the cost-benefit analysis at cost.

  • And as it turns out, those changes in smoking prevalence don't have to be very large before

  • you get enormous costs mounting up in the cost-benefit analysis.

  • Sally: Can we end on an optimistic note?

  • That's the hardest question I asked.

  • Clive: Well, there is...it's difficult to be optimistic, to be honest.

  • While we still have the public health community who've made terrible judgments about this

  • with a lock on the democrats in congress, that is going to be difficult.

  • There are signs of light.

  • Not all democrats are looking at this in the same way, and I think there might be some

  • who want to take a more open-minded approach and see the public health benefits.

  • There is more and more public health people willing to say, like we do, that this is actually

  • a good thing.

  • It's an opportunity, not a threat.

  • So that might weaken that stance.

  • There is a way to get what everybody wants, and that's a reason to be optimistic, which

  • is a proportionate non-discriminatory approach to regulation.

  • It's a reasonably light touch that focuses on the use of standards that are applicable

  • to all devices, much lower cost way of regulating, much lower cost for the regulator as well,

  • by the way, and much better for the consumers and the manufacturers because they know what

  • they're getting.

  • And that's a framework within which people can focus on innovation for consumers, rather

  • than innovating or spending all the technical resources, meeting regulatory requirements.

  • It's possible that the legal case will succeed, but, you know, that's a toss of the coin.

  • Who knows?

  • Sally: So there is a good regulatory model.

  • Let's just hope that it's adopted.

  • Clive: Let's get busy on that.

  • I think many of the advocates on the harm reduction side haven't made the reality of

  • that clear enough to the democrats in congress.

  • They haven't given them reassurance that not wiping out the industry, which is what the

  • current thing will do, is the only way of control.

  • It's not a get-out-of-jail-free card.

  • There is a middle ground in which you can use the standard setting powers of the FDA,

  • or set up a regime that allows that that will actually give everyone what they want.

  • Sally: Well, I'll accept that as optimism.

  • Thank you so much for coming.

  • It was wonderful talking to you.

  • Clive: Thank you, Sally.

  • I appreciate that.

Sally: We're here with Clive Bates, one of my most esteemed colleagues in the world of

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克利夫-貝茨談電子煙、吸食和減少菸草危害 - 採訪全文|VIEWPOINT (Clive Bates on e-cigarettes, vaping, and tobacco harm reduction - Full interview | VIEWPOINT)

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    Danny Wang 發佈於 2021 年 01 月 14 日
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