E Cigarette Advocacy Webinar featuring Greg Conley, Dr. Michael Siegel and Dr. Tim McAuley

00:05 Steve Miller: Hi everybody! My name
is Steve Miller and I had one job to do and that was to press ‘record’ at the beginning
of the webinar. Well, I didn’t do such a great job. I hit ‘record’ late so I missed some
introductions and I missed the very first question. In case you don’t know, we have
three presenters in this webinar. They are: Greg Conley, who’s the President of the American
Vaping Association, Dr. Timothy McAuley, and Dr. Michael Siegel. Both of these guys are
e-cigarette researchers. So I apologize for that. That’s on me without a doubt. And so
I missed the very first question and the first question that was asked that it was to Greg
Conley was, “What does the FDA Deeming & Regs moving into the OMB mean in plain terms?”
So we’re gonna pick it up with Greg’s response to that question. 00:47 Gregory Conley: It means great danger
for the future of the e-cigarette industry, the FDA’s Deeming Regulation, which was put
out to the public about 18 months ago and then was opened for public comment. That regulation
would impose such strict terms on the e-cigarette industry that we could very easily see 99.9%
plus of the 100,000 plus vaper products available on the market today end up banned. The long
story short of that is that they want to require what’s known as retroactive pre-market review,
and in English that means that they want for every single nicotine vaper product on the
market a potentially $2 to $10 million, maybe even more expensive for e-liquid products,
a $2-10 million application just to have a chance of being able to stay on the market.
So that regulation has moved to the Office of Management and Budget at the White House.
We do not know if the FDA has changed it. Now is a great time for e-cigarette companies
to take meetings with the OMB to discuss the dangers of that and it also reflects the need
for a bill called HR 2058 in the House to pass. 02:09 Speaker 3: Great. Well, thank you for
that information, Greg, and we know we’ve been talking about the FDA Deeming Regulations
for some time now, but it seems like they’re finally coming to fruition here. Moving on
to the next question, you were almost weren’t able to attend today because of a city council
meeting in Philadelphia. Can you tell us a little bit about what’s going on there? 02:25 GC: Sure. Philadelphia last year banned
vaping everywhere that smoking is banned. Then they, shortly thereafter, closed off
a loophole that would’ve allowed bars to get permission to allow vaping or smoking in their
establishments. The next step in their renewed war on tobacco and non-tobacco e-cigarettes
is to ban the sale of vaper products and tobacco in pharmacies or any store with a pharmacy.
That seems to be the enriched CVS bill of 2015. CVS chose to not sell tobacco products.
It appears now they’re lobbying to make sure their competitors can’t do it either. The
good news though is that that hearing, that was supposed to be today, was cancelled so
at least it would appear that maybe one or two or three members of the council started
to push back against this ridiculous proposal. [chuckle] 03:27 S3: And do you know if any other cities
have similar legislation pending? 03:33 GC: Pending, I don’t know. I know many
cities have passed these sorts of laws. I think San Francisco has one. Dr. Siegel would
know, but Boston may have passed something similar to that. I may be wrong. But it’s
a completely ineffectual policy that just leads somebody to go down to the gas station
rather than the CVS to get cigarettes. But that’s the kind of thing tobacco control likes. [chuckle] 04:01 S3: Well, we all have heard about the
public health report out of England, which is supporting that smokers switching to e-cigarettes.
They’re saying that switching to e-cigarettes is actually a healthy alternative than smoking
traditional tobacco and do you see this having a positive impact on that fight here in the
US for e-cigarettes? 04:20 GC: Yes. There are great positives to
that report. We have been slowly accumulating the great deal of scientific evidence that
we now have. Public Health England’s report as well as the letter that was co-signed by
12 different public health orgs in the UK, including Cancer Research UK, Action on Smoking
and Health, and the Royal College of Physicians. That is going to be helpful in getting legislators
to recognize that, “Okay, so the American Lung Cancer, Heart, they’re all aligned against
e-cigarettes and won’t say one positive thing about them.” But, over in England, perhaps
the second best health care system in the world and they’d probably argue over in England
that they are the number one and we’re the number two. [chuckle] 05:10 GC: That they are taking a common sense
approach to this. So we’ve already started to see that this is having an impact. Unfortunately,
we can expect, just as we’ve seen in the past year, where seemingly every week a journal
is publishing new junk about e-cigarettes. It’s going to still be tough because it’s
gonna be the Public Health England report and maybe the one positive journal article
that comes out every month versus four to eight to 10, maybe even more than 10 negative
articles that are going to be coming out. 05:43 S3: Geez. Well, recently, you were testifying
in front of the Indiana State Legislator and in your testimony you were discussing the
Public Health England report. And they seem to be fixated on the fact that it wasn’t a
USA-based report. Now, are you finding that opponents dismiss this report because it’s
not USA-based? 06:00 GC: Not typically. That was fairly new
to me, this idea that it’s not created in the United States therefore it can’t be taken
seriously. This person that was bringing that up, I believe, is a liberal Democrat. And
a lot of the climate change data that we have, a lot of the studies are coming from overseas.
So perhaps in that area, he’s okay with foreign research, but that’s mostly just a cop out
from somebody that, even if you put 100 US studies in front of him, he wasn’t gonna change
his mind. 06:37 S3: Yeah, his opinion is fixated. 06:39 GC: Yes. 06:40 S3: So you’re on the front line of the
e-cigarette fight while traveling around the country and advocating for people’s rights.
Is there one myth or fallacy that you encounter that bothers you more than any others? 06:51 GC: It would probably just be the flavour
argument because when I quit or rather when I tried to quit smoking with an e-cigarette
in 2009, all I had access to were these little Chinese cigalikes that were only available
in tobacco and menthol. Those flavors just reminded me of how great a cigarette would
taste. But I got the product in October and duly used for a month or two and then quickly
relapsed back to smoking. And it wasn’t until August 2010 when I had a watermelon flavored
vaper product that I was actually able to quit. And so to go to these hearings and to
just hear these people throw out with no care or regard recklessly that, “Well, they come
in flavors just to appeal to children. These are the companies target marketing to children.”
And sometimes I’ll confront those people in the hallway and say, “Well, I’m standing next
to a business owner who lives 10 minutes away from you and this business owner has a 100
flavors in their store and will you tell this person straight to their face, ‘You’re marketing
to children’?” And very quickly they disengage from the conversation because it’s a lot easier
to just go forward with hype and conjecture when speaking generally than it is to actually
look somebody in the eyes and say, “You’re marketing to children.” It’s a fallacy. 08:12 S3: Well, great. Thank you for that,
Greg. Post Deeming Regulations, what are some of the avenues for advocacy that vapers can
take? 08:20 GC: Well, now is the time for vapers
to go to casaa.org, C-A-S-A-A.org. And go to the Call To Action page for HR 2058, which
is a bill in Congress that would force the FDA to regulate all vaper products on the
market. Rather than just take the easy route of banning 99.9% of them, we need to add co-sponsors
to that bill. Our best chance for co-sponsors are Republicans so if you have a Republican
representing you in the US House, take the extra step. Make a phone call, go to your
local vape stores, try and get them educated because they’re the best people to actually
have a physical meeting with the congressman or his staff to talk about how jobs will be
lost in his or her district if this bill is not passed. 09:13 S3: Great. Thank you for that, Greg.
We’re gonna open up the Q&A session now to some of the attendee questions. So we got
another one here that kind of it’s on the same topic we were just talking about. Is
there any other avenues for vaping advocates that once the Deeming Regulations come out,
they can continue to fight for e-cigs? 09:30 GC: If HR 2058 is not passed in the
budget deal at the end of the year, 2058, the bill will remain alive throughout 2016.
And if you haven’t read the Deeming Reg, which I don’t blame you for, there is a two-year
implementation window from the date that the FDA finalizes the regulation to the date that
the deeming ban begins. And so during that two years, we still need to be pushing for
the passage of HR 2058. Without that bill, our advocacy efforts won’t mean much. But
regardless, at the state level, this industry is still gonna be under attack because, even
if the FDA releases their final regulation, the people that wanna destroy this industry
will still be able to say, “Oh, well, it’s two years from now. God knows what could happen
in the next two years. We need to take action now.” [chuckle] 10:26 GC: So we need to get more vendor groups
formed in states. We need consumers to make sure that they vote in the November election
and that their elected officials know that their vote is influenced by how they voted
in the past on vaper and that their future votes will be influenced by how they vote
on vaper issues. 10:50 S3: Excellent. Well, thank you for that
great description there, Greg. We got another question here. Can you describe the work that
the ABA does? And how do you differ from the other advocacy groups? 11:01 GC: Sure. Essentially, ABA is not a
trade group. I work a lot with SFATA. I’m a huge fan of theirs as a trade organization.
I have helped set up chapters in different states for them and helped them train and
advise their lobbyists day to day when they’re facing threats. So we do not represent the
industry nor do we really represent consumers. That’s CASAA’s job. ABA is the media mouthpiece
for policy, promoting policies that encourage the growth of small businesses in this industry,
not because we represent them but because as a public health advocate I believe that
the best path forward for helping more and more smokers quit is for innovation to happen
and innovation happens under small businesses. 11:52 GC: With ABA, we put out press releases
that get picked up oftentimes by large newspapers, large websites about new studies on e-cigarettes,
the consequences of taxes, usage bans, research that has been dishonest. We often use Dr.
Micheal Siegel, Dr. Farsalinos, other people like that as primary sources. And then part
of my job is flying around the country, meeting with vendors, meeting with vapers, educating
them on issues. I was just in Washington DC yesterday where I gave a presentation at the
Food and Drug Law Institute conference on tobacco about e-cigarettes in a post-deeming
world. Hoping to do more of those type of conferences outside the e-cig world. But essentially,
I’m on the front lines. And one of the nice benefits of not representing the industry
is that whereas SFATA rightfully has to be nice in most of their communications I can,
like Dr. Siegel, be a little more hard-edged when appropriate and when people are really
lying and harming public health. 13:07 S3: Great. And we certainly appreciate
the stern advocacy for the e-cig industry. We have another question here and it relates
back to the public health report out of England. And it being an England report, is there any
reason to discredit the England-based reports solely on the fact that it was produced in
another country? 13:26 GC: No. No. I could see people in third
world countries perhaps saying that science is not valid. I don’t know if would understand
that, but when it comes to England, where it’s the first or second best health care
system in the world with some of the most premier academics in the world, it simply
doesn’t make sense to discredit the report based off of that. There have been other attempts
to discredit the report. There’s a part of me that wishes that they had not said 95%
less hazardous than smoking and just instead just said, “Far, far less hazardous than smoking,”
so then we wouldn’t have had this war between academics about whether or not that figure
was appropriate. But, no, long story short, there’s absolutely no reason to discredit
a report simply because of the country of origin. 14:21 S3: Yeah, it kind of started a debate
about percentage points and not the actual evidence that was included in the report. 14:26 GC: Yes. I had a conversation yesterday
with Dr. Michael Eriksen, who is an FDA grantee, runs School of Public Health in Georgia, and
that was one of his contentions. I think we may disagree. I think he may think that 95%
is too low, whereas I think 95% is too high. Or rather I think it’s more 96, 97, 98 and
he might think it’s lower than 95. But regardless, the debate may have been a little differently
coming out of that report if it just made clear, “Look, these aren’t safe, but they
are far, far, far less hazardous.” [chuckle] 15:09 S3: Exactly. Well, Greg, I definitely
appreciate the information you’ve given us here. It’s been very informative. Before we
move on to the next panelist, we’d like to see if any of the other panelists wanna comment
on the questions that were asked previously. Alright, well, I think we’re good. We’re gonna
go ahead and move on. Our next speaker is an expert in Air Quality and Human Health
Exposure and Risk Assessment. In addition, he is a Multi-Award-Winning Environmental
Expert and World Renowned Environmental Leader and the Chief Executive Manager of CHANGE,
Dr. Timothy McAuley. Dr. McAuley, thank you for joining us today. 15:41 Dr. Timothy McAuley: Sure. Thank you. 15:43 S3: So, Dr. McAuley, you are an expert
in Air Quality and Human Health Exposure and Risk and you have done extensive work in secondhand
vapor exposure, especially with how it compares to tobacco smoke. So how does e-cig vapor
compare to the secondhand smoke of traditional tobacco? 16:00 DM: In general, vapor has a substantially
less amount of particulate. That’s generally because vapor is actually it’s not a combustion
process. So you’re actually producing a vapor that quickly volatilizes and therefore has
a rapid dissipation, whereas something that’s more of a combustion-based product would tend
to exist longer, generate other types of particulates that can actually pose secondary exposures,
such as PM2.5 and things that you don’t see in electronic cigarette vapor. 16:38 S3: Oh great. Well, thank you for that
explanation there. Do you believe that e-cigarettes pose any risk to public health in terms of
secondhand vapor? 16:45 DM: Oh, I’m not gonna say that they
don’t pose any risk. As Greg mentioned, that from the research that I’ve done and been
involved with with various panels from the American Heart Association, with the National
Heart, Lung, and Blood Institute and the research that we’ve looked at in my discussions with
Jon Samet, who is a global health leader in his own right, again I think the jury is still
out. The big question is, “What’s the research doing now to show what those levels are?”
I do agree that, at this point in time, it’s very difficult to put percentages on what
we feel is safe versus unsafe. The main question that always stems from is the current policy
of EPA with nicotine to say that there is no safe level. 17:31 DM: From the research that I’ve been
involved in, we’ve effectively demonstrated that although it’s been a few years since
we’ve done and the new research we’re about to do, the amount of nicotine contained within
the liquids has substantially dropped from when we did our research. So I would expect,
even with the lower levels that we found in comparative analysis against a standard high-nicotine
cigarette, that those levels would be even lower now. So bringing me back to the point
that we can’t definitively ever say that they are completely not safe. However, the level
of risk that we found originally actually is substantially lower in terms of adverse
health effects when compared to an actual cigarette. 18:19 S3: Thank you for that, Dr. McAuley.
We all want to know that it’s risk aversion. We wanna stay away from risk as much as possible. 18:26 DM: That’s right. 18:27 S3: Limit that exposure. We’re hearing
an awful lot about reports about chemicals found in e-cigs, specifically formaldehyde,
and I was just curious that, in any of your studies, have you encountered high level of
formaldehyde in some of these e-liquids? 18:39 DM: We have not. And again, part of
the research that I’ve been involved in, I mean, a big question that sort of goes against
a little bit about with what Greg was mentioning is that there’s a lot of questions that need
to look at, not only just the liquids themselves, but what’s going into them in terms of flavorings
’cause we’re… Part of the concern here is that aerosol science says when you’re dealing
with public health is the fact that you’re not always dealing with the primary constituent
of that air toxin or air contaminant, but you’re also dealing with the secondary by-products
that can be formed. And so in some of these cases, when we mention about the toxins and
things that are later on air containments, we’re talking about regularly commercially
available products that people can purchase and those kinds of things. We’re not talking
about people in the basement making up different formulas and so forth. So I wanna make sure
that that point’s clear because it always does come up to say, “Well, what if I buy
it off a friend who… ” 19:38 DM: That’s totally different. We’re
talking about people coming into a store or a vendor that has to sell similarly approved
products. So you have to understand that with those different types of components and things
like that, we didn’t see typically high levels of formaldehyde, but we need to also understand
more, which is an area of research that we’re looking into. Also, to understand the organic,
potentially inorganic and other types of bottles or aldehydes or carbonyls that may exist in
different concentrations in various types of liquids because again there isn’t just
one type of strawberry, one type of vanilla. There are thousands of different types so
it would take some good comparative studies to assess that, to be sure. 20:28 S3: Great. Thank you for that answer,
doctor. Now, you did some work with the American Heart Association. What was involved with
that work and what were the conclusions did you draw from that work? 20:38 DM: Yeah, I was a part of a panel of
experts last year, though I think there was about 10 of us. We were asked to put together
a policy statement that essentially was published in Circulation, which is a journal of the
American Thoracic Society. You can find it on Google. And basically, what it was, it
was about a three-month panel. We met a couple of times every couple of weeks and really
evaluated, “What’s the status of the literature? What do we know from an international perspective?
Who’s doing what?” And we were really able to sift through a lot of the research studies
that people did that we just found weren’t… Even though it was published, were they credible?
Do they actually have a good basis for their research? 21:25 DM: And so from the ones that were compiled
that we found that were actually scientifically sound, we actually also had a couple policy
analysts on the committee and really the idea was to evaluate the public health aspects
of the electronic cigarettes, the social aspects, the psychometric aspects, policy statements.
Where’s the replication between what we’re seeing versus potential inclusion to already
smoke-free laws set by the FDA for regular cigarettes? Where should all this go and where
should we been? And, overall, part of the conclusion that we found were essentially
that we need to do more research. We need to get better answers. For the time being,
it was the recommendation of the American Heart Association and that of the panel that
electronic cigarettes, at least for the inclusion, for those areas that are not definitive, to
just simply say, “You know what? It’s okay. Put these under these smoke-free laws.” That
doesn’t include state, county, town bans. This is just in general. With the caveat that,
as research becomes available and as we are doing more and more, that there is this caveat
that we will be able to revisit this and that those laws can then be lifted. 22:47 DM: So this is not in stone, but that
was the outcomes really of the panel and that there’s again more investigative research
that needs to go into teen addiction and teen social aspects and peer pressure on electronic
cigarettes and the whole psychometric relations of, “Are electronic cigarettes used as gateway
drugs or gateway devices? Or does it keep people hooked on smoking versus so they just
quit period?” And, despite the evidence, that there has been reductions in lung cancer related…
So, all these things were summarized and then our thoughts were put together into the paper
and published. 23:27 S3: Yeah, it seems like it’s such a
new product, it’s such a new device on the market, that we really need to take the time
to get this research done and let all this be collected. 23:35 DM: Yes, that’s correct. And the hard
part here is that you’re working on a moving target. This is a very dynamic industry. This
is not static by any means. And as you start to begin doing research in one area, suddenly
you start to notice that, “Hey, there’s a new take on the market. There’s three dozen
new liquids that just came out or there’s… ” All these things that, as researchers, you
need to really get that 30,000 foot view. And, thankfully, there are other researchers
out there like Dr. Siegel and all the colleagues of mine that are also looking at other pieces,
so that collectively… Although we may not be talking every day about who’s doing what,
but papers are getting published and people are able to find those and start to put things
together and that helps drive new research initiatives. 24:31 S3: Great. Thank you for that, doctor.
Now, we may have heard reports about the National Park Service recently classifying electronic
cigarettes as a tobacco product and then banning them in all areas where smoking is prohibited.
Do you have any thoughts on that legislation? 24:45 DM: Well, again, people in general right
now are going to default into what’s already regulated because the amount of money that…
For example, the National Park Service or any federal agency, they are not gonna spend
the time and effort right now to go against the regular policy aspects of what’s in place.
They’re just gonna go with the flow because they can. And so if you start to think about
the amount of… And again, this is not a positive thing. But if you are a federal agency
and you’re trying to mandate something, what’s gonna be easier for you? Stick it under something
that already exists or actually say, “You know what? No, no, no. Let’s start funding.
Let’s start putting out all this money and let’s stop and look… ” You’re just gonna
have to take the easy way out. And that was, again, going sort of coming back to the policy
statement that was written. Yes, it was part of the recommendation that we made. It wasn’t
that the panel was saying any federal agency, “Please, put this under a smoke-free law.”
It’s more of, “Look, for the ease of not having to worry about battling over what should go
where from individual components, now we leave it open to the research to then dictate what
laws should then be lifted and what regulations put in place.” 26:06 S3: Great. Now, some have countered
that by saying that burning charcoal contains far more harmful toxins than e-cigarettes
do and even cigarette smoke and therefore they should also be prohibited in parks. 26:17 DM: Yup. And most of them are. Technically,
they are. You can’t go to a Class 1 area at a National Park and decide to have a charcoal
fire. It’s a protected region. So there are specific areas inside parks that you are not
allowed to do that. So all these different sources are taken into account for the protection
of the environment and public health. 26:40 S3: Great. Well, we’re gonna move on
to some questions from the attendees now. So we have a few rolling in here. We have
one question: “People think about secondhand smoke and secondhand vapor as something that
lingers in the air, but what is the risk of residual nicotine or chemicals left behind
surfaces that vapor touches?” 27:02 DM: Well, there’s always… That’s really
the main component of what we call basically ‘third party exposure’ where you can get the
deposition of a vapor on furniture, clothing, walls, and things like that. A lot of that
is subject to concentrations, air changes per hour in the particular room or area that
we’re talking about, the volume of the room. If you have somebody coming in to a room and
they’re standing there once a week for five minutes and vaping, chances are you’re gonna
be able to go in there and really detect any kind of incidence? Probably not. If it’s somebody
who’s living there and they’re spending three or four hours there a night we often get that
kind of stuff and they’re vaping the entire time they’re there, chances are that you will
have the ability to actually detect, through wipe samples and things like that or bulk
analysis, actual various chemicals that would be derived from the actual vapor themselves. 28:00 S3: Great. Thank you for that, Dr. McAuley.
We’ve got one more question here for you and then we’re gonna move on to our next presenter
so give me one moment to get that question up. Let’s see, what is it gonna be? Okay.
“Dr. McAuley, it seems that the most salient arguments we encountered are made without
comparison of risk and what can we look forward to in scientific literature that directly
demonstrates the risk to the end-user and bystanders?” 28:29 DM: Well, the end-user is… That’s
a separate entity in a lot of the research that needs to be done. Those are various inhalation
toxicology studies, deposition modeling, various things to actually look at the transport of
the vapor and the constituents into the lung tissue, coming from epithelial into the blood
and things like that. There’s a lot of things that take place on that and those are typically
much more of a control-based risk study with a certain amount of known going in, how much
is retained, how much is exhaled. The general basis that we know at least from the amount
of the users, given that the vapor and the amount of water and things like that can actually
be generated, also with the function of relative humidity and temperature, we know the lungs
have more humidity and things like that. We expect a higher retention rate of the vapor
than what’s actually exhaled. 29:24 DM: So when you’re dealing with understanding
the risk, part of it also goes to the bystander is that’s a big data gap right now. That is
an area of research that is certainly a focal area. My overall risk perspective again depending
on the bystander is much, much lower than that of a comparison to an actual cigarette
or to the user, so we often can’t. It’s no different than basically trying to look at
the user. We know they’re being exposed, we know their exposure risks are higher, but
as far as bystanders and people in other areas, it’s really a function of environment, meaning
where you are, what are you doing and things like that. If you’re standing in an urban
center and heavy traffic at 7:00 AM in the morning and you’re directly downwind of a
major intersection and you’re standing there, chances are somebody’s standing next to you
with an e-cig who’s blowing it and is coming to you versus what you’re breathing in from
the traffic, it’s extremely negligible to what you’re actually inhaling from all of
the actual combustion products. So, again, depends on where you are, what your environment
is, and what your overall exposures are to other sources. 30:35 S3: Well, thank you for your time today,
Dr. McAuley. We really appreciate it. It’s a lot of informative information. We got some
more questions rolling in and we may reach out to you via email to respond to some of
those questions? 30:45 DM: Yeah. Anytime. 30:46 S3: And then at the end, we’re also
gonna do another general Q&A, so if you have time, we’d invite you to stick around for
the remainder of the webinar. 30:52 DM: Certainly. No problem. 30:53 S3: Great. So our final speaker today
is a Professor in the Department of Community Health and Sciences at Boston University School
of Public Health. He also has been a researcher in the tobacco control area for the past 25
years. He writes a popular tobacco policy blog with the rest of the story where he provides
commentary and insight on the current tobacco policy issues, Dr. Michael Siegel. Dr. Siegel,
thank you for joining us today. 31:17 Dr. Michael Siegel: Well, thanks for
inviting me. 31:18 S3: We’re glad to have you here and
thank you again for taking time out of your busy day to be with us. So we got a few questions
rolling in so we’re gonna jump right into a couple of them here. Actually, did you wanna
make a few statements before we started that? 31:30 DS: Well, I just wanted to very… I
wanted definitely to leave most of the time for questions. I do wanna address two issues
that I think are really critical. I wanna make sure everyone understands. And the first
one is “What exactly is entailed in this new application?” So according to the proposed
FDA Deeming Regulations, every electronic cigarette product will have to submit a new
application. And I wanna talk just briefly about what’s in that application because as
Greg Conley mentioned it’s very expensive to do these applications and the fear is that
it would literally put so many vaping stores and smaller businesses out of business. I
just wanna explain why that is so people understand. 32:18 DS: The new application standard, by
statute, by law, is that you have to show that your product will be beneficial to the
public’s health. And that’s the exact standard you have to show. And you have to show not
only that it’s beneficial for the users, but that it won’t be harmful to non-users. So,
in other words, you have to not only show that the product is much safer than cigarettes,
you also have to show that youth or other non-smokers are not gonna start using the
product. And as Dr. McAuley explained, the research is rather complex. It’s not that
easy to do this research. You have to have large-scale studies, clinical trials to show
the effectiveness of the product in getting people to quit smoking. You have to do large
population studies to find out whether kids are progressing to smoking after experimenting
with e-cigarettes. And so it’s incredibly expensive and complex to do these studies. 33:19 DS: So the requirement for a new application
is essentially a death sentence I think for, I would say, most businesses that aren’t trained,
aren’t qualified, and don’t have the resources to do this kind of thing. If you’re a small
vape shop owner, how are you gonna put this complex application together? And you may
not even understand the research issues involved. So I think that and I’ve been arguing for
a long time that this general approach that the FDA has taken makes no sense. What it
would do, if these Deeming Regulations turn out to be the same as what they proposed,
is it would essentially hand the entire industry to maybe 1% at the very top. Mainly, the tobacco
companies and maybe the largest of the independent electronic cigarette companies. 34:12 DS: The second thing I just wanna briefly
touch upon is the way that the FDA is regulating the marketing and communications. What can
e-cigarette companies say about their products? And, unfortunately, it looks like the approach
that the FDA’s gonna take has two major problems. The first is that they’re not allowing any
health claims to be made because if a health claim is made, the FDA’s gonna interpret that
as meaning that the product is to be regulated as a drug rather than a tobacco product, which
makes it almost impossible to do. You have to a minimum of about eight years of clinical
research to get it approved as a drug. So you, basically, can’t make health claims,
which means that you can’t tell customers the very basic truths about the product, that
these products were intended to help smokers quit, that they are highly successful for
many, many thousands of smokers to help them quit. Unfortunately, that’s something that
you can’t say. 35:13 DS: But to make the problem even worse,
the FDA also looks like they’re going to apply the FD Modified Risk Regulations to these
products. What that means that you can’t even tell customers that these are safer than cigarettes,
can’t make a comparative claim between these products and any other tobacco product. And
to make things completely ridiculous, you can’t even tell people that there’s no tobacco
in the product. Because if you say that there’s no tobacco, that’s what’s viewed as a reduced
exposure claim and that’s not allowed without pre-approval. And the procedure to get approval
is essentially impossible. And so I think perhaps the worst part of the FDA, the proposed
regulations at least, is that it would prohibit electronic cigarette companies from telling
the truth to their customers about the two main benefits of this product: First, that
it can help you get off cigarettes. And, second, that it doesn’t contain tobacco and therefore
is much, much safer. 36:18 S3: Well, thank you for that, Dr. Siegel.
And in the customer service department here at White Cloud, we deal with that every day
on a firsthand basis. So I appreciate you mentioning that. We have a few questions rolling
in here. In your recent blog, you discussed the anti-tobacco movements treatment of e-cigarettes
and do you have any thoughts on why anti-tobacco groups are so negative about e-cigarettes? 36:38 DS: Well, this is a question that I
have been thinking about actually for the past four years. So I’ve had a lot of time
to think about it. And I, finally, have come up with what I think is the most logical answer,
and I think what it has to do with is the fact that this is a movement that is concerned
about its prestige, and we didn’t think of this. This is not an idea that we thought
of and I think that is a huge thing. I think that if this had come out of the tobacco control
community, for example, if Stan Glantz had come up with this idea of having a noncombustible
alternative to cigarettes that would be a lot safer and he had been the first one to
come up with the idea, I don’t think that we’d be seeing the opposition we’re seeing
today. I think a lot of it is because this is not something we thought of, that this
is something coming from outside industry that, in some cases, involves tobacco companies
to make it even worse. 37:42 DS: And so I think it’s really a threat.
I think these products are really a threat to anti-smoking groups because I think deep
down they realize that this is a game changer. I think, subconsciously, they recognize this
is a game changer. This could completely transform the market and that’s scary to them because
they can’t claim that they were the ones who did it. They would have to say, “You know
what? We failed and these other companies came in and they came up with a solution that
none of us thought of.” And that’s why I think this is such a threat and that’s why I think
they’re ignoring or misrepresenting all of the research showing the benefits of these
products and that they’re demonizing them because I think that it may not be conscious,
but I think subconsciously, this is a real threat and they’re gonna do everything they
can to try to keep their prestige and to clear their self-esteem. I think that’s really what’s
going on here. 38:39 S3: Well, Dr. Siegel, to expand on that
a little bit more, what are the dangers of the continued negativity of these groups towards
the e-cigarettes? 38:46 DS: Well, I think there’s two major
issues and one of them has nothing to do with electronic cigarettes. It actually just has
to do with smoking. The groups claim that their goal here is to try to lower rates of
smoking. And, in fact, one of the main arguments they’re using about e-cigarettes is that these
products are gonna cause people, especially youth, to start smoking. But, ironically,
the danger of what they’re doing is they’re really undermining the public’s appreciation
of how bad cigarettes are because, by comparing cigarettes to e-cigarettes and by basically
saying, “E-cigarettes, it’s just as bad as e-cigarettes,” or… I’m sorry, “E-cigarettes
are just as bad as real cigarettes,” they’re really undermining the public’s appreciation
of just how bad cigarette smoking is. And, by failing to acknowledge that there’s a major
difference between a product that contains and combusts tobacco and a product that actually
has no tobacco in it whatsoever and involves no combustion, it’s completely distorting
the public’s appreciation of why cigarettes are so bad. 39:48 S3: They’re bad for two reasons: One,
because they involve burning and, two, because they involve tobacco. And if you take those
two things away, you automatically are gonna have a much safer product and these groups
are undermining that knowledge. And, in the long run, I think it’s actually gonna lead
to more people smoking. People are gonna get scared. They’re gonna maybe instead of trying
to quit with e-cigarettes, they’ll decide, “You know, it’s not worth it. If these things
are almost as bad as cigarettes, why should I bother?” And the second thing that I think
is harmful about these misrepresentations is that it, I think, is leading to policy
that doesn’t make sense. I think that, by putting out this misinformation, policy makers
are really getting the wrong information and they’re using that wrong information to make
policy and, of course, the greatest example is the FDA and everything that we just [40:42]
____. 40:44 S3: Well, now, the American Lung Association
in the Upper Midwest recently said that smoking tobacco may be no more harmful than e-cigarettes.
How do you respond to that egregious claim? 40:55 DS: Well, I think that it’s… We respond
to it by basically pointing it out and saying that this is just absolutely wrong. That this
is a lie and I’ve done that repeatedly on my blog. What’s frustrating to me is the fact
that some of the mainstream organizations are saying things that just aren’t true. We
can go right to the top and the CDC itself is basically stating that electronic cigarettes
are a tobacco product. There is nowhere on the CDC site, and I’ve gone through it extensively.
There is nowhere on their entire site where it actually acknowledges that e-cigarettes
do not contain tobacco. If you did not know that and you’re a member of the public or
even a vaper or a potential vaper who’s looking at their site for information, there is nowhere
where they actually say it doesn’t contain tobacco. And, in fact, by classifying as a
tobacco product, I think they’re misleading people into thinking that it does indeed contain
tobacco. So I think this problem goes all the way to the top. It’s not just a local,
in the Midwest, some branch of the American Lung Association. This is really coming out
of national groups, such as the CDC. And, to me, that’s what’s so disturbing about it.
This is the nation’s leading public health agency and they’re not even willing to acknowledge
that electronic cigarettes don’t have tobacco in them. 42:20 S3: Well, thank you for that explanation,
Dr. Siegel. Regulations are designed to help keep the public safe and healthy, but at what
point do regulations begin to have the exact opposite of the intended effect and begin
to do more harm than good? 42:33 DS: Well, I think that they begin to
do more harm than good when they essentially violate the science. In other words, when
policy is evidence based, then I think it does protect the public’s health. When policy
loses that evidence base and when other factors, such as politics or ideology, start to influence
the policy, that’s when I think that it really can have adverse effects. And I think that
with e-cigarettes, that’s exactly what we’re seeing. The FDA, itself, has stated that they’re
not sure that e-cigarettes are any safer. It’s actually in the Deeming Regulation itself.
It actually states that they’re not sure that e-cigarettes are any safer than smoking. And
so if you’re starting from that base, where you basically are ignoring overwhelming evidence,
you’re not gonna come up with policies that actually protect the public health. And, in
this case, the entire approach that the FDA is taking, by requiring these new product
applications rather than simply setting safety standards for e-cigarettes, I think it’s actually
gonna harm the public’s health rather than protect it. 43:45 S3: Well, that’s a great explanation
there, Dr. Siegel. We’re gonna open up to a general Q&A. So we’re gonna bring all of
the panelists back in, open the mics up, and we’re just gonna fire out some questions from
the attendees here and whoever would like to chime in on these questions, please feel
free to go in. We have a first question here, and it’s about a drug like Chantix, was approved
so easily, yet they cause harm to the user where e-cigarettes really haven’t been seen
to do that. Would anybody like to comment on that discrepancy there? 44:14 DM: I’m not sure I understand the question. 44:18 GC: How do you justify Chantix getting
approved so easily? 44:19 S3: Yeah, how do you justify Chantix
getting approved so easily and e-cigarettes having such a fight to get approved? 44:28 DM: Well, you wanna go ahead, Dr. Siegel?
Before I… 44:31 DS: No. No. Go ahead. You start. I’ll… 44:33 DM: First of all, with any drug that’s
passed through, I’m not… I, first of all, would be skeptical… Not that I wouldn’t
say that I wouldn’t use the word ‘easy.’ All drugs go through a very intense clinical trial
period, things in those lines, at least they’re supposed to. As far as… Again, I think part…
From the electronic cigarette, it goes back to the point of a very dynamic industry. Things
are constantly changing and so how you’re monitoring that and how you’re trying to track
that back is extremely difficult. And Chantix doesn’t have several different types of derivatives
and formulas and things. It’s a drug and that kind of stuff. So that’s what we’re facing
here is you’re looking at really it’s a sort of an apple… It’s not really an apple to
apple comparison versus trying to identify… Just understand what Dr. Siegel… He’s right.
And one of the biggest things that we, as people in the research field, say is “Science
has to drive policy here.” And just a lot of what’s going into drug development so far
there’s science in terms of just looking at drug interactions and so forth. 45:49 DM: So in this field of e-cigs, it’s
a very difficult field. And so I think overall, the more evidence that we can put out there,
you will start to get people looking and I’ve seen enough. I’ve seen people that when I
first started doing this research, who just literally were like, “Oh, this is a drug delivery
device. This is just gonna kill people.” Who are actually like, “You know, Tim, the research
you guys are doing, this is actually really interesting and have changed our mode of thinking.”
And these are highly known scientific experts, so it’s just a matter of time. 46:24 S3: Great. Thank you for that, Dr. McAuley.
Dr. Siegel, did you have anything to add about that question? 46:28 DS: Yeah, just to add one thing to what
Dr. McAuley said and that’s that I think it’s important to recognize that a lot of the side
effects of Chantix, in terms of these psychological or psychiatric effects, such as suicidal ideation
or suicide, weren’t really recognized until the post-marketing surveillance. In other
words, after the drug was already approved. And the same is true with a lot of drugs that
have been taken off the market, like Vioxx is a great example where, when it was approved,
they didn’t know about these side effects. So I don’t think we can blame the FDA for
approving Chantix in the first place. The problem is that when you have these post-marketing
adverse effects that are [47:11] ____, because the drug is already on the market, the burden
of proof is really to lean towards keeping it on the market unless the side effects are
so bad because the drug is already having benefits for people. 47:28 DS: I think the interesting thing about
electronic cigarettes is that, in a way, with most drugs, they’re not put on the market
until they’re approved, but electronic cigarettes have basically been on the market in the United
States for at least eight years now. And so, in a sense, we actually do have a post-marketing
surveillance period that’s taken place and we haven’t seen any major acute health effects
from the product. If people were dying of pneumonia or pulmonary embolisms or heart
attacks, we would see these kind of major events happening because we have some experience
with millions of people using it for five, six, seven years. With anything, I think that
experience leads to a more optimistic investment of where e-cigarettes are compared to where
most drugs are at the time that they’re approved. 48:22 S3: Great. Thank you for that, Dr. Siegel.
Mr. Conley, would you like to add anything on that question before we move on? 48:28 GC: I think Dr. Siegel and Dr. McAuley
covered it sufficiently. 48:32 S3: Great. Well, we have another question
here and this one’s directed actually at Dr. Siegel. Aside from the PHE study, can you
point to two or three other leading studies that advocates can use in their work to educate
policy makers on the best science behind e-cigs and vaping? 48:48 DS: Well I think the most convincing
study that’s out there is the study that Dr. Riccardo Polosa did where he basically took
asthmatic patients, patients, smokers with asthma and he gave them electronic cigarettes
and some of them switched completely to electronic cigarettes, others only partially, and then
he monitored their lung function before and afterwards with spirometry testing and he
also asked them about respiratory symptoms and his findings were pretty amazing. What
he found was that both the subjective symptoms of the smokers and their… I’m sorry. Both
the subjective symptoms of the smokers and the objective evidence from the spirometry
completely improved after they switched to electronic cigarettes and this was after only
about a month period. So it was a very short-term effect. 49:49 DS: And the most interesting thing to
me was that this improvement was seen not just in those who switched completely to e-cigarettes
but also in the newer users who reduced the amount that they smoked by a large amount.
And so, to me, this is the strongest evidence that you can use to convince policy makers
because it’s actually direct clinical evidence. How could smoking be as bad as electronic
cigarettes if asthmatic smokers who switched to e-cigarettes had a dramatic improvement
in their health? So I think that’s the type of study that I think is being ignored by
so many people, so many of the opponents of electronic cigarettes. 50:30 S3: Great. Thank you for that, Dr. Siegel.
And after the webinar, we’d like to get a link to that study so we can send that around
to all the participants as well. We have another question here that’s directed towards Mr.
Conley. What, if anything, can be done to move the public health community, as a whole,
towards acceptance of tobacco harm reduction through the use of vapor products? 50:52 GC: I think that we need to look at
a place where the approach has worked in large part, England. Where you have very passionate
consumer vapors as well as passionate members of industry, reaching out and trying to develop
relationships, trying to lightly challenge them without being too harsh unless they’re
too far gone. I got to sit down, I got to talk to a few people yesterday that are in
the middle on the e-cigarette issue, but they are very important voices. There are some
that will never be reachable. The government relations people at the American Cancer, American
Heart, those people can’t be reached. People have tried. But there are opportunities at
your local health departments, state health departments, attorney general’s offices. Those
are great places to start. 52:08 S3: Great. Thank you for that, Mr. Conley.
We got one more question here before we have to end the webinar and this one just simply
states, “Is Big Tobacco scared? Is that why they’re getting into e-cigarettes and do they
possibly see that this is the way of the future and they want to cash in on this?” And this
question is open to any of the panelists. 52:32 DS: Well, I guess I’ll start and just
say that absolutely the answer is yes. The big tobacco companies I think, unlike much
of the public health community, understand that non-combustible tobacco products are
gonna be the wave of the future. Anti-smoking groups, like it or not, this is where the
future is gonna go and the tobacco companies wanna be in the game. They realize that there’s
a limited shelf life for combustible tobacco products, in the United States at least. And
that, as smoking rates continue to decline and decline, what you’re seeing is that its
lowest level historically among both adults and youth today and it keeps going down drastically. 53:18 DS: So I think they realize that the
combustible market is declining and they wanna be in on the action to make sure that, as
the forms of nicotine delivery change, that they’re in the game. And, unfortunately, it’s
kind of sad to me that ironically the tobacco companies are the ones who wanna play this
game changing, they wanna be in this game changer, where the anti-smoking groups, who
you think would be the ones who would actually want to transform the entire market from a
combustible market to a much safer alternative nicotine delivery market, you would think
that they wanna play ball with this, but they’re trying to stop the game. And to me, that’s
probably the greatest irony in public health of my time. 54:07 DM: I think a lot of that, just to add
to that very point, is the fact that again often people that are advocating against these
have the least amount of information to be able to critically review and criticize in
terms of a scientific aspect. So that’s part of what we’re dealing with. As Greg said earlier,
you’re dealing with so much information that’s coming out that’s just pure junk from people
who aren’t really qualified to be doing science that’s getting the ears and attention of those
people that are able to actually… That are publishing good research. So it’s really just
a matter of ensuring that good science is done by those that are doing it so that you
have that evidence to then drive that policy forward rather than… I think you’ll eventually
see people fall off once… 54:56 DM: Once you put something peer reviewed
in front of people, that science is backing up that policy, suddenly you’ll start to notice
a lot of mouths in the crowd shut because you can’t argue with it because that’s the
benefit of doing peer reviewed research, not white papers, not things just putting out
in the general public, but research that is published in journals that’s publicly accessed,
but has passed a very critical piece of a process that has shown… So you know what?
This work merits publication that came to their use. That’s how the National Ambient
Air Quality Standards for environment public health are set. They’re set after research.
Do they always get to the levels we may want ’em? Maybe not, but that’s the idea behind
it. The NAAQS were not set based off recommendations from advocacy people. They were set from researchers,
people doing the work, looking at the health effects, looking at the impacts on the environment.
That’s what we have to do here is to ultimately get enough research out there that’s gonna
drive that policy home. You will start to see everybody off just fall. 55:58 S3: Well, thank for that, Dr. McAuley.
We’ve had a lot of great content here in this webinar. Unfortunately, we’re running short
on time now. We also got a lot of questions that we didn’t get a chance to get to during
the webinar, and I just wanna reassure everybody that we are gonna respond to these questions
via email in the next couple of days. We’ll respond to those questions via email in the
next few days. So thank you so much to all of our panelists and all the attendees who
came in today, and we just wanna let everybody know that we’re gonna continue with this web
series and that we hope everybody can join us again for the next one. So thank you again
everybody for attending and hope everyone has a great day.