Thursday, April 2, 2015

CASAA: California Call to Action! Multiple bills threaten...

CASAA: California Call to Action! Multiple bills threaten...: UPDATED 4.2.15 AB 768 (the Tobacco Free Baseball Act), introduced by Assemblyman Tony Thurmond and co-sponsored by Senator Mark Leno, wo...

Thursday, September 11, 2014

Stop demonising a potentially useful product for smokers

Compulsory regulation of electronic cigarettes could spoil a safe substitute for smoking.
Illustration of e-cigarette
Source: christophkadur /
Electronic cigarettes are becoming more popular but are not licensed as medicines
The market for electronic cigarettes is rapidly growing and no proof of serious health risks associated with their use has so far emerged. Much of the media coverage has focused on the risks and potential downsides of these products. We must take a step back from these unfounded fears and consider e-cigarettes in a different light.
E-cigarettes offer a powerful response to the grotesque burden of disease caused by smoking, something that should excite anyone interested in public health. They provide a satisfactory alternative to smoking because the user is still consuming nicotine, the active agent in tobacco. But when people inhale vapour from an e-cigarette, they are not breathing in the harmful products of combustion in cigarette smoke.
There are 10 million smokers in the UK (approximately 20% of adults) and around 1.3 billion worldwide — the current annual premature death toll attributed to smoking is 100,000 and six million, respectively. The World Health Organization (WHO) estimates one billion premature deaths from smoking in the 21st century on current trends.
The public health proposition is that e-cigarettes can substitute for cigarette use and provide a satisfactory alternative to smoking, with e-cigarette use expected to be at least 20 times safer than smoking tobacco cigarettes[1].
A survey published by Action on Smoking and Health in July 2014[2] showed that 2.1 million people in Great Britain are using e-cigarettes and around one third are now ex-smokers. To affect the immediate welfare and long-term health outlook of 700,000 people is an achievement, requiring no NHS resources or public spending. One Wall Street analyst, Bonnie Herzog of Wells Fargo Securities, projects that vaping will surpass smoking within a decade[3]. Other analysts are less bullish, but many see great potential. If anything close to this scale of change does occur, it will be one of the most remarkable public health phenomena in history.

Risks and concerns

No one could claim that vaping is entirely benign but it does not need to be to make large inroads into the burden of smoking-related disease. Studies of liquids and vapour chemistry reveal traces of contaminants and thermal breakdown products that are potentially harmful, but at low levels unlikely to pose a material threat.
The most comprehensive review of e-cigarettes so far was conducted by Igor Burstyn of Drexel University, Philadelphia[4].
“The current state of knowledge about chemistry of liquids and aerosols associated with electronic cigarettes indicates there is no evidence that vaping produces inhalable exposures to contaminants of the aerosol that would warrant health concerns by the standards that are used to ensure safety of workplaces,” he concluded. “Exposures of bystanders are likely to be orders of magnitude less, and thus pose no apparent concern.”
We cannot rule out unexpected effects in the future but, for now, we know enough from the basic chemistry involved, toxicology of liquids and vapours, trials of the products and surveys of users to be confident that e-cigarettes can have a positive impact on the health of those who switch from smoking.
Opponents of e-cigarettes now concentrate on ‘population’ arguments. This is the idea that, although vaping is considerably less hazardous than smoking, at population level it could be more dangerous because it changes the way people smoke. For example: e-cigarettes might serve as a ‘gateway’ to smoking for adolescents; they might dissuade people from quitting smoking; and they might ‘renormalise’ smoking in society.
In fact, none of these hypothetical effects have so far materialised. As expected, e-cigarettes are displacing smoking, as one of the UK’s foremost experts in smoking cessation, Robert West of University College London, points out.
“Evidence conflicts with the view that electronic cigarettes are undermining tobacco control or ‘renormalising’ smoking, and they may be contributing to a reduction in smoking prevalence through increased success at quitting smoking,” he says.

Scare stories

Anyone hoping to gain an insight into the safety of e-cigarettes by reading newspapers should tread carefully. There is something of a propaganda war raging and many spurious claims are published uncritically. For example, the fact that particle size of the e-cigarette vapour aerosol is similar to that of tobacco smoke led Metro to write an article on 30 July 2014 with the headline “E-cigarettes ‘may also cause lung cancer’”[5]. Of course, the chemistry of tobacco smoke does the damage, and that is completely different to e-cigarette vapour.
Professionals looking for guidance on the evolving science should consult literature reviews in the formal academic press. The most recent and authoritative is by Peter Hajek and colleagues, published in the journalAddiction[6]. The authors conclude: “Health professionals may consider advising smokers unable or unwilling to quit through other routes to switch to [electronic cigarettes] as a safer alternative to smoking and a possible pathway to complete cessation of nicotine use.”
A further source of concern to critics is the role of the tobacco industry in the e-cigarette market. In practice, it is hard to see how this could be negative: the tobacco industry is threatened by e-cigarettes and has entered the market by buying firms to catch up. To survive, each company will need to produce high quality alternatives or risk losing market share to other tobacco companies or non-tobacco e-cigarette companies. Competition will force them to make better products and, as a result, they will become a driver of the wholesale switch from smoking to vaping.

The risk of regulation

The development most likely to put the e-cigarette market at risk is not the tobacco industry but excessive regulation. It might seem like a paradox, but at the heart of the regulatory challenge there is a ‘double negative’: being tough on e-cigarettes is being tough on the competitive alternative to cigarettes — and that may lead to more smoking and more ill-health than it prevents.
In a report on electronic nicotine delivery systems (ENDS) published in August 2014, the World Health Organization (WHO) called for tougher regulation on e-cigarettes. It issued a series of recommendations, including a ban on indoor use until there is evidence that exhaled vapour is not harmful, stopping sales to children and putting health warnings about nicotine on products. It also recommended that manufacturers, and others, should be prevented from describing the products as smoking cessation aids, until there is scientific proof of their effectiveness.
However, the science base behind the WHO report was strongly criticised within a week of publication by UK and European experts[7] and the Department of Health was quick to reject WHO’s proposal for a legal ban on vaping in public places[8]. Policy analysts warn that excessive tough regulation of e-cigarettes give cigarettes and smoking an easy ride and effectively protects cigarette sales and causes more disease and death. The battle over the right balance of regulation and commercial freedom is sure to rage on.
At the moment, e-cigarettes are regulated as general consumer products but since 2010, the Medicines and Healthcare products Regulatory Agency (MHRA) has encouraged companies to submit medicine licence applications voluntarily for e-cigarettes to be approved as medicines.
The European Union has produced e-cigarette regulation in the revised Tobacco Products Directive that will come into effect from May 2016 for e-cigarettes containing up to 20mg/ml of nicotine. It includes a ban on advertising that will protect cigarettes from competition; limits on liquid container sizes; and bold warnings covering 30% of the pack. The measures were negotiated behind closed doors with no credible scientific or legal basis. E-cigarettes with stronger concentrations of nicotine, used by more dependent smokers, will require authorisation by MHRA as over-the-counter medicines in the UK.
The system of medicine regulation is not well suited to regulating recreational products because the products are not medicines, either in law or common sense. It applies heavy costs, burdens, restrictions and unnecessary technical demands that would limit the range of products and number of suppliers, while acting as a barrier to innovation. It is likely that only tobacco companies entering the business would be able to comply.

What should happen next?

The future plans for tougher regulation could damage the market for e-cigarettes. A rethink is needed — either through a policy change or the European Court of Justice. There is little wrong and much that is positive with the market as it functions today. It would benefit from some genuine light touch regulation that builds consumer confidence but the proposals in place could destroy perfectly good firms and greatly limit the diversity of products.
Some changes would be useful, such as purity and safety standards for liquids, some design constraints for vaping devices, tamper-proof liquid containers, proportionate health messages that encourage smokers to switch and restrictions on marketing similar to those in place for alcohol. Regulation in moderation could assist, but this is a market-based revolution that should be led by consumers, innovative producers and engaged retailers. If regulators intervene too strongly, they will end up doing far more harm than good.
Clive Bates worked with 53 specialists in nicotine science and public health to co-ordinate and deliver a letter to Dr Margaret Chan, the Director General of the World Health Organization, arguing against excessive regulation of e-cigarettes and urging caution in the handling of safer alternatives to smoking when WHO hosts the sixth conference of the parties to its Framework Convention on Tobacco Control, due to be held in Moscow on 13 October to 18 October 2014.
Citation: The Pharmaceutical JournalURI: 20066415

Wednesday, July 2, 2014

CASAA: Overview of CASAA's Action Plan Regarding Proposed...

In April 2014, FDA released its proposed regulation attempting to exert regulatory authority over e-cigarettes as tobacco products. To better understand the import of these regulations, please see our summary of the what and why of the deeming regulation and CASAA’s preliminary analysis of proposed regulations.

Early on, we asked CASAA members to be patient and to refrain from making formal comments (you are allowed to submit more than one comment) about the proposed regulations until CASAA leadership  had sufficient time to review the regulations and offer guidance. The membership has been patient at a time when every instinct we have is to react, do something -- do anything! -- because we know that these regulations, if enacted in anything remotely resembling their current form, will decimate the industry and destroy the diversity in the marketplace. And, of course, it's the diversity in the marketplace, the ability of customers to customize the experience, that  makes this product such an extraordinarily effective alternative to smoking. There is a very real possibility that such regulations would eliminate the entire legal market for e-cigarettes.

The last few weeks, we have spent our days (and nights) analyzing the proposed regulations (241 pages), the FDA's regulatory impact analysis (81 pages), the Tobacco Control Act itself, and data about the FDA's operations to assess the real-world implications of the proposed regulations. We have thus far found no reason to believe that these proposed regulations will provide any benefit to consumers, especially in light of the crippling and insurmountable restrictions it will impose on industry, and, by extension, consumers. They appear to be all cost and no benefit.

This is not a battle that is going to be won based solely on comments to the proposed regulations. Accordingly, we are going to attack this on several different fronts. Before the draft regulations were published, we had envisioned a single Call to Action with several suggested actions. However, upon seeing the details, we decided the best strategy to effect positive change is to prepare a comprehensive Action Plan which consists of several Calls to Action issued at staggered dates to maximize effectiveness.

The Action Plan will include, among other things, Calls to Action with specific requests directed towards members of Congress. To support this massive undertaking, we have subscribed to CQ Roll Call, a program which will help connect our members easily and in a targeted fashion with their state and federal legislators on specifically crafted campaigns we design.   This tool will be valuable as we move forward to the next stage of our battle, and it will also help us in our continuing efforts at state-level advocacy.

The CQ Roll Call program represents a significant commitment of financial resources, but we have been careful with the money our membership has donated over the years, practicing sound fiscal management to ensure that the money will be available when the time is right. That time is now. We are working with the company to get the program rolled out as quickly as possible, and we have been told that we should have it functional enough within the next two weeks, in time for our second Call to Action (which will be the first of several directed at Congress).

We appreciate that vapers and harm reduction advocates are anxious to make substantive comments sooner rather than later, but CASAA is asking that you continue to wait. There is absolutely no benefit to making substantive comments now, and, in fact, it can undercut the very reasonable and truthful position that we have taken that the comment period must be extended. Early comments will lack the useful information that we will be able to assemble over the coming months. While FDA is required to read all comments, it would not be surprising or unreasonable if they were to gloss over those that are submitted early as being completely uninformative (as, indeed, many are, based on our spot review of what has been submitted and posted  to the web). Moreover, organized interests who support the regulations, or who want to suggest that they become even more prohibitionist, will undoubtedly wait until near the deadline to submit; they will take advantage of what they can learn about our arguments by reviewing the early submissions.  

For these reasons, CASAA has decided to wait to issue its guide for consumer comments until only a few weeks before the deadline (currently July 9th, 2019.) Submitting comments earlier than that has no benefit and might have substantial costs.

In the meanwhile, there are still many things you can do to prepare:

  • Submit your story to the CASAA Testimonials Project

  • Prepare a one- or two-paragraph summary of your personal story for use with various Calls to Action that will be issued.

  • Continue to encourage others to join CASAA.  Membership is free, and more members will increase our influence and reach. CASAA members are more informed on the issues, and having the proper information  will result in more effective advocacy.

  • Ask vendors to provide information on CASAA to their customers:

    • CASAA has a "We Support CASAA" Graphic for use on commercial sites.
    • CASAA offers vendor kits at cost which is designed to let customers know about CASAA.
    • Informational flyers and brochures are also available on our website for download to print and hand out at vape meets and stores or even for employers and medical professionals.

  • Let people (including your favorite vendors) know about CASAA’s social networks and encourage them to join our forum on ECF, follow us on Twitter, subscribe to our blog and/or join us on our Facebook page and Facebook discussion group, so they do not miss important information.

  • Share CASAA’s blog posts and emails about the FDA rules and our plan, so they also know what we are doing and what to expect.

  • If you have a blog, video or radio show about vaping, share CASAA's plan, tell your audience about the Calls to Action (including non-FDA actions) and encourage them to participate.

  • If you know someone with a vaping website, blog, video or radio show, ask them to share CASAA's plan, tell your audience about the Calls to Action (including non-FDA actions) and encourage them to participate.

Also, while the proposed FDA regulations are by far the biggest issue we are dealing with, we continue to address other matters, including state and local Calls to Action. (And we encourage our members to continuing paying attention to state and local legislation!) We also just released our White Paper on civil disobedience.

CASAAs FDA Actions Regarding Proposed Regulation:

Tuesday, June 10, 2014

Breaking News: New study shows no risk from e-cigarette contaminants... by Carl V Phillips

[UPDATE  3: The published version of the paper, at BMC Public Health, is nowhere.]
[UPDATE:  Here is CASAA's press release about this.]
[UPDATE 2: Here is the post of the press release at CASAA's main blog (same content as above link, but with a link to here for discussion -- so a better choice if you want to share the press release).]
CASAA is delighted to announce that the first research study funded by the CASAA Research Fund (thanks to all of you who donated to that!) has been released.  The study, by Prof. Igor Burstyn, Drexel University School of Public Health, is available at the Drexel website, here (pdf).  Burstyn reviewed all of the available chemistry on e-cigarette vapor and liquid and found that the levels reported — even in those studies that were hyped as showing there is a danger — are well below the level that is of concern.
And that assessment applies to the vaper himself.  The exposure to bystanders is orders of magnitude less and of no concern at all.
The paper is technical, of course, but I believe it does a great job of communicating for readers at many levels.  It puts the results in very clear and useful terms — exactly what policy makers need for making decisions.
For the first time, we have a definitive study that can be used to respond to claims that contaminants in e-cigarettes are dangerous and that there is a hazard to bystanders that calls for usage restrictions.  Existing individual chemistry studies have been difficult for anyone other than an expert to understand (which is why we gave a grant to an expert to understand them!), and a naive interpretation of individual studies (just reading what the authors editorialized about their results) gave the impression of “dueling studies”, with some showing a problem and some not.  While many THR advocates made an effort to make sense of and use the existing literature, it was almost impossible to do so effectively.  Burstyn’s analysis solves that problem and shows there is no duel:  All of the studies, including the “bad” ones, show that there is no worry.
I cannot overstate it:  This is a game-changer for anyone trying to respond to misinformation about the hazards of e-cigarettes.  Before we had an apparently contradictory mess on this topic.  Now we have clarity.
I have to say that I am genuinely surprised that the results are quite so definitive, and I assume that will be true of anyone else of was seriously trying to assess the risks, rather than just cheerleading.  We were all confident that the risks were minimal, but we could not previously reach a (good news) conclusion as strong as the one in the paper.
The list of key conclusions in the paper:
  • Even when compared to workplace standards for involuntary exposures, and using several conservative (erring on the side of caution) assumptions, the exposures from using e-cigarettes fall well below the threshold for concern for compounds with known toxicity. That is, even ignoring the benefits of e-cigarette use and the fact that the exposure is actively chosen, and even comparing to the levels that are considered unacceptable to people who are not benefiting from the exposure and do not want it, the exposures would not generate concern or call for remedial action.
  • Expressed concerns about nicotine only apply to vapers who do not wish to consume it; a voluntary (indeed, intentional) exposure is very different from a contaminant.
  • There is no serious concern about the contaminants such as volatile organic compounds (formaldehyde, acrolein, etc.) in the liquid or produced by heating.  While these contaminants are present, they have been detected at problematic levels only in a few studies that apparently were based on unrealistic levels of heating.
  • The frequently stated concern about contamination of the liquid by a nontrivial quantity of ethylene glycol or diethylene glycol remains based on a single sample of an early technology product (and even this did not rise to the level of health concern) and has not been replicated.
  • Tobacco-specific nitrosamines (TSNA) are present in trace quantities and pose no more (likely much less) threat to health than TSNAs from modern smokeless tobacco products, which cause no measurable risk for cancer.
  • Contamination by metals is shown to be at similarly trivial levels that pose no health risk, and the alarmist claims about such contamination are based on unrealistic assumptions about the molecular form of these elements.
  • The existing literature tends to overestimate the exposures and exaggerate their implications.  This is partially due to rhetoric, but also results from technical features.  The most important is confusion of the concentration in aerosol, which on its own tells us little about risk to heath, with the relevant and much smaller total exposure to compounds in the aerosol averaged across all air inhaled in the course of a day.  There is also clear bias in previous reports in favor of isolated instances of highest level of chemical detected across multiple studies, such that average exposure that can be calculated are higher than true value because they are “missing” all true zeros.
  • Routine monitoring of liquid chemistry is easier and cheaper than assessment of aerosols.  Combined with an understanding of how the chemistry of the liquid affects the chemistry of the aerosol and insights into behavior of vapers, this can serve as a useful tool to ensure the safety of e-cigarettes.
  • The only unintentional exposures (i.e., not the nicotine) that seem to rise to the level that they are worth further research are the carrier chemicals themselves, propylene glycol and glycerin.  This exposure is not known to cause health problems, but the magnitude of the exposure is novel and thus is at the levels for concern based on the lack of reassuring data.
It is worth expanding on the observation about propylene glycol and glycerin a bit:  While there is no affirmative reason to believe that the level of exposure experienced by vapers is hazardous, we have never before had a situation where millions of people had such a high level of exposure.  Thus it is worth gathering data on what happens, just to make sure there is no small subtle effect.  This contrasts with the levels of the much-hyped contaminants, which pose no concern at all.  It is also important to remember that this refers to the vaper herself; there is no such caution for bystanders, who have far far lower levels of exposure.
This paper should immediately become a central point in all political advocacy to stop anti-e-cigarette regulations, as well as trying to encourage smokers to adopt THR.  The key talking point that should be used is this (my words, not Burstyn’s):
The only expert review of all of the studies found that there was no risk from the chemicals to vapers, let alone bystanders.  This took into consideration the studies that you are referring to [note: assuming this is being used as a rebuttal to some claim of chemical hazards].  Indeed, even the results of the studies that have been used to generate alarm represented levels of chemicals that were too low to be of concern.
For those of you who have any comments for the author, particularly peer review (or even non-peer review) comments for improving on the working paper before it is submitted to a journal[*], please use the comments section of this post.  The author has agreed to monitor one page (this one), but will probably not see it if you post a comment at another blog, on ECF, etc.
[*Footnote: To head off a concern I have heard a few times, no, there is not a problem with the author releasing a working paper before submitting to a journal.  A handful of medical and general-science journals -- those that are trying to sell copies as if they were a glossy magazine -- like to have "exclusives" of previously secret studies (which, by the way, is why they publish far more papers that are shown to be wrong than do more serious journals).  Serious science journals generally prefer that the paper is circulated and commented on before they are asked to deal with it.  Indeed, in several of the more serious sciences (public health will catch up in a few decades -- perhaps), working paper versions are considered the key source of scientific communication, and the eventual appearance in a journal is more of an afterthought and happens long after everyone has already read the paper.  Real peer review is what starts now (here) when every interested expert can read and comment, rather than at a journal where a couple of people with their limited knowledge are the only ones reviewing it.
[Of course, that knowledge does not help you if you are dealing with people who do not understand how science works and are not likely to listen long enough to learn.  There will be retorts of "that is not a peer-reviewed publication" (which is actually not true -- it was reviewed before the author released it).  Your best talking point in response to that is something like, "So are you saying that in a few months, when the paper appears in a journal, you will agree that it is all correct and change your position?"  If you are responding to someone who claims to be an expert, you can add "So, why don't you just review it like other expert readers have done, or are you admitting that you are not expert enough to do so?"
[UPDATE 3 vers.2: Later posts here that relate to this study can be found at this tag.]

Wednesday, May 14, 2014

Tobacco Smoking-Attributable Morbidity, Mortality and Economic Costs...

In the U.S., tobacco kills more Americans than AIDS, alcohol, car accidents, murders, suicides, drugs and fires combined.

Sources: U.S. Department of Health and Human Services. The Health Consequences of Smoking—50 Years of Progress. A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014. Printed with corrections, January 2014.

Read the full report here.