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.