Clive Bates on e-cigarettes, vaping, and tobacco harm reduction – Full interview | VIEWPOINT


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.

18 thoughts on “Clive Bates on e-cigarettes, vaping, and tobacco harm reduction – Full interview | VIEWPOINT

  1. Big Government is usually a solution in search of a problem. One might argue that Government has a role in warning citizens of "potential danger", but adults don't need an all powerful Nanny dictating behavior.

  2. I'm vaping on my RX2/3 mod with "vanilla cupcake" juice from vapin USA, Green Bay, WI. I've switched from a pack a day of Marlboro Red 100's and I really do feel better. It's been about 6 months and I will never go back to smoking.

  3. My smok alien and big baby beast delivers nic to me just fine. 3 months without a stinky stick and no more sludgy lungs. I FEEL FUCKING AWESOME.

  4. the trend is vaping not smoking push vaping instead of smoking. if my kids smoked. I would be pissd off and I would push them to vaping instead. or if just started smoking put a stop to it if I can. if not then vaping is better to there helth at the end of the day

  5. This is really good, and not full of waffle!
    I stopped smoking by accident when my son bought me an e cig last Christmas- I've not had a cigarette since, but it still kinda feels like I'm smoking!

  6. nicotine in vaping nearly killed me i got nicotine poisoning but now i get no nicotine in my liquids i quit smoking .

  7. I went from a pack a day of camel 99's to vaping on blue raspberry sour belts a few times a day. Big tobacco hates people like me and they hate vaping.

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