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Nicotine/Tobacco Research and Policy Experts Endorse Tobacco Harm Reduction in Letter to World Health Organization

Fifty-three tobacco research and policy experts from 15 countries today endorsed many of the tobacco harm reduction principles that I have advocated for 20 years. In a widely publicized (here) open letter (available here) to Dr. Margaret Chan, director of the World Health Organization, they declared:“Tobacco harm reduction is part of the solution, not part of the problem. It could make a significant contribution to reducing the global burden of non-communicable diseases caused by smoking, and do so much faster than conventional strategies. If regulators treat low-risk nicotine products as traditional tobacco products and seek to reduce their use without recognising their potential as low-risk alternatives to smoking, they are improperly defining them as part of the problem.” Just as I have done before (here), the experts warn that harsh regulation of e-cigarettes could have the unintended effect of protecting cigarettes: “On a precautionary basis, regulators should avoid support for measures that could have the perverse effect of prolonging cigarette consumption.Policies that are excessively restrictive or burdensome on lower risk products can have the unintended consequence of protecting cigarettes from competition from less hazardous alternatives, and cause harm as a result. Every policy related to low risk, non-combustible nicotine products should be assessed for this risk.” The letter’s signatories also endorse a tax strategy that I have promoted for many years (here):“The tax regime for nicotine products should reflect risk and be organised to create incentives for users to switch from smoking to low risk harm reduction products. Excessive taxation of low risk products relative to combustible tobacco deters smokers from switching and will cause more smoking and harm than there otherwise would be.” The letter points to the enormous public health gains that are possible with tobacco harm reduction:“The potential for tobacco harm reduction products to reduce the burden of smoking related disease is very large, and these products could be among the most significant health innovations of the 21st Century – perhaps saving hundreds of millions of lives.”It is encouraging to see such widespread international support for my long-held positions.Original author: Leanora
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E-cigarettes debate catching fire

JOHNSTOWN — As debate ignites over the burgeoning electronic cigarette industry and a regulatory crackdown looms, former smokers using the handheld vaporizers to kick rolled tobacco, as well as those trying to keep kids safe in light of aggressive marketing and a seemingly lawless distribution framework, are huffing and puffing on both sides of the argument.The upcoming battle for the mainstream acceptance and fostering of e-cigarettes will likely hinge on politics, said Holly Loupe, co-operator of locally owned e-cigarette store Vape Vibe LLC. She and her husband, Brennan, company president, opened their newest location in the East Hills Plaza, Richland Township, last month.Loupe said Vape Vibe’s role is educating consumers. That’s evidenced by the average transaction time, which is around 20 minutes, she said. Buyers learn how to clean, refill and keep the product from being damaged. But they get more than just a rundown of how the thing works – they gain insight into the technology and nicotine-infused “juice” from the vaping enthusiasts on staff.“There were some barriers in the beginning, mostly because of bad experiences from bad purchases,” she said.More often than not, she said, retailers – especially fly-by-night online “vape” stores – won’t provide customers the information they need to get the most out of it, or vape safely.“It was very time-consuming. It took us a lot of time to really explain to people how to use the product and help them use it appropriately,” she said.Salespeople will even take follow-up calls from customers to help them with upkeep issues or give them a refresher on the device.“There’s so much that the public is unaware of as to how they operate. We really gear ourselves as a full-support vaporizer shop,” she said.Reports of faulty or hazardous equipment and easy access to minors are just some of the many reasons the U.S. Food and Drug Adminstration is beginning to clamp down on the industry. Explosive and emergent growth in the past few years has caused Mitch Zeller, the FDA’s director of tobacco products, to dub the vape industry as the “wild, wild west.”“We have e-cigarettes that are exploding in car chargers, e-cigarettes that are exploding in wall sockets at home when people try to recharge them. We have e-cigarette users who are saying, ‘This is the greatest thing that I ever had. It has helped me get off cigarettes.’ ... We have a doubling of the number of middle and high school kids who used the e-cigarettes between 2011 and 2012,” he told “PBS NewsHour” in April, around the time the FDA released its new regulatory proposal for public comment.“It’s going in all different directions. And there’s absolutely no regulation of manufacture, sale or distribution of these products.”Subpar merchandise – and the distributors who sell it – is one reason why there’s such mixed opinion on e-cigarette safety, Loupe said. Zeller agreed it’s a state of “buyer beware.”Loupe said all of the Vape Vibe merchandise is tested before it goes on the floor. It also gets a 14-day warranty. They’ve even dropped vendors that have high rates of manufacturer defects.She said that more often than not, malfunctions boil down to user error, personal damage and – coming full circle – a lack of knowledge in properly using the product.“We haven’t had any issues with any of our batteries for people who operate their equipment appropriately,” she said.But who’s thinking of the children? There is no federal law currently in place that prohibits the sale of e-cigarettes to minors, although most states have their own restrictions. In spite of that, Loupe said, retailers usually classify them as tobacco products anyway, so the ban is informal, but there all the same.Recent media reports have highlighted the myriad enticing flavors of e-cigarette liquid as a way to draw in youths.Vape Vibe is working on offering somewhere around 60 flavors, including cotton candy, banana nut bread and goji melonberry. Many of those are produced by Vape Vibe at a certified laboratory.But why would fruit flavors be "kids only?" Loupe said she doesn’t see why adult taste buds should have to suffer.“Do you like orange soda? Do you like raspberry tea? It’s the same thing,” she said. “Adults like options just like anybody else does. When they switch to something pure, they don’t want it to taste bad.”The marketing, whether geared toward kids or not, is there. Because the e-cigarette ads are not technically selling tobacco, they can also go places Marlboro and Camel can’t, like television.According to an April study published in Pediatrics, the official journal of the American Academy of Pediatrics, Nielsen TV ratings data show youth exposure to e-cigarette TV ads rocketed over 250 percent from 2011 to 2013. More than three-quarters of those ads appeared on cable networks and were reportedly for a single e-cigarette brand.But when all is said and done, is it really healthier? Study data included in the FDA’s recent regulatory proposal show that while e-cigarette vapor still contains toxicants and known carcinogens, the quantity is “significantly less than those in tobacco cigarettes and tobacco smoke and similar to those contained in nicotine-replacement therapies.”Further study into smoking cessation by JAMA Pediatrics showed in March that tobacco smokers who tried e-cigarettes at least once were more likely to quit tobacco within the next year. It even ups the abstinence rates for regular smokers.Dr. Matt Masiello of Windber Research Institute said there still hasn’t been enough time to properly study e-cigarettes. But they’re on the market all the same and being pushed as recreation, although they lack any clinical or federal certification. That’s something he would admonish.“It’s controversial,” he said. “It really comments on our market-driven approach to health-related issues.“With that being said, the studies really are not out there yet to determine completely whether we should be concerned about these e-cigarettes. ... From a public health perspective, there’s really no clear sign that it’s beneficial.”Tell that to Zeller.“If we could get all of those people to completely switch all their cigarettes to noncombustible cigarettes, it would be good for public health,” he said last month during a hearing on e-cigarettes.He said there are currently dozens more studies underway at the administration.But Masiello said those studies only explore the issue from a fiscal perspective, and not from a health perspective.“(E-cigarette makers’) intent is not necessarily positive. It’s recreational,” he said. “Whether it’s going to help or hurt the process of reducing the smoking rate is really up for grabs.“(More studies are) going to bring us down the path of spending more money on a market-driven product, rather than something important, like lung cancer.”Justin Dennis is a multimedia reporter for The Tribune-Democrat. Follow him on Twitter at @JustinDennis.Original author: Luisa
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E-Cigarettes in the Media: Do e-cig ads target children or irresponsible parents?

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Recently, ABC News posted a story stating e-cigarette advertising targets kids. In the article, it stated Research Triangle Institute International found from 2011 to 2013, e-cigarette TV advertisements that reached children increased by 256 percent, and those that reached young adults increased by 321 percent.

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GSK E-Mail Proves Pharma Industry Is Lobbying to Get E-Cigarettes Stringently Regulated

If there was ever any doubt that Big Pharma is doing everything in its power to stop increasingly popular electronic cigarettes from competing with their own smoking cessation products, this recently revealed e-mail written by a Glaxo Smith Kline vice-president to SANCO (the European Commission’s Directorate General for Health & Consumers) puts those doubts to rest.The email conversation between Sophie Crousse, the Brussels-based vice president of European public affairs for GSK’s consumer health-care division, and Dominik Schnichels, of SANCO, was made public last week through a freedom of information request made to the health and consumer affairs division of the European Commission, according to Bloomberg. It shows the pharmaceutical giant’s desire to see electronic cigarettes regulated as medicinal products, just like other nicotine replacement therapy products on the market. “We believe in responsible and proportionate regulation for all nicotine-containing products as medicinal products,” Crousse writes in an email dated October 30. “We believe in a single access system, without differentiation in clinical/regulatory and distribution advantages provided only to e-cigarettes that are not similarly provided to NCPs specifically intended to help people reduce and quit smoking. We believe devices that put nicotine in the human body need to be held to a single, consistent high standard of quality.”To better get GSK’s point across, Crousse also included a bullet-point list of reasons why e-cigarettes should be regulated as medicinal products and not as general products, as well as a number of reasons why the EU shouldn’t have a two-tier regulatory system. Glaxo Smith Kline believes only medicinal products legislation can ensure that the most robust safety and quality standards are applied to NCPs, that it’s the only one that ensures that there is a penalty system in place for manufacturers and marketing authorization holders that do not comply with quality and safety standards and that it provides the most appropriate labeling of the risks and benefits associated with NCP use.Glaxo claims -cigarettes should not be classified as general products for several reasons, including that a simple notification system for marketing NCPs is not enough to confirm the safety and efficacy of these products and that General Products Legislation does not provide enough safeguards corresponding to the health risk category of nicotine and other chemical substances contained in electronic cigarettes. Furthermore, categorizing electronic cigarettes as “lifestyle products” excludes representation of their function as a smoking cessation aid, which leaves consumers unaware of the risks and benefits of switching from smoking to NCPs. “Allowing e-cigarettes to be marketed as tobacco/consumer products without any health claims would potentially open a gateway to nicotine addiction and encourage wider nicotine usage,” the email reads.You can read the full list of arguments put together by Glaxo Smith Kline, here.GSK also sought assurances that the revised tobacco products directive will apply to e-cigarettes already on the market and ensure a ban on advertising, according to an analysis of Article 18 of the TPD by the pharmaceutical company, which was also shared with two other major nicotine replacement therapy product manufacturers, Johnson&Johnson and Novartis. According to Caroline Almeida, a spokeswoman for the New Jersey-based Johnson&Johnson, her company  is also “strongly in favor of” regulating all non-tobacco nicotine products, including e-cigarettes, as medicines. “This is the best way to ensure all non-tobacco nicotine products are advancing public health by means of effective, high-quality and safe products,” Almeida added.In the published emails, Glaxo Smith Kline vice-president, Sophie Crousse admits to meeting with a certain Member of the European Parliament (whose name was not disclosed) after the ENVI vote in July, and sending her company’s analysis of the revised tobacco products directive‘s Article 18 to “all Member States representatives in Brussels” ahead of the Council meeting of October 31st.Simon Steel, a spokesman for London-based Glaxo Smith Kline, confirmed the company’s position in an e-mail statement: “Safety is our number one priority and we support the smoker’s right to choose from a selection of products that have well established safety and efficacy profile in helping them quit smoking. All nicotine-containing products including e-cigarettes should be reviewed and regulated to the same standard of safety.”It’s clear that Big Pharma has it in for electronic cigarettes, and after learning that e-cigarettes are severely affecting nicotine replacement therapy sales, I can say I understand their motives. That doesn’t mean they’re right in their judgement of the situation. Most of their arguments can easily be contested, and actually have been by reputed health scientists like Professor Riccardo Polosa, in his recent paper, Achieving Appropriate Regulations for Electronic Cigarettes“. Ultimately, it’s all about the money, but you probably knew that already…- See more at: http://vaperanks.com/gsk-e-mail-proves-pharma-industry-is-lobbying-to-get-e-cigarettes-stringently-regulated/#sthash.NfRWYGKh.dpufPosted by: Vranks GSK E-Mail Proves Pharma Industry Is Lobbying to Get E-Cigarettes Stringently RegulatedOriginal author: Daren
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Safety of electronic cigarettes and the Loch Ness Monster

This is the famous “Surgeon’s Photograph,” showing a monster that allegedly lives in the lake Loch Ness in Scotland and is often cheerfully called by its nickname, Nessie. Despite this picture and several pretended sightings, there is no genuine evidence for the existence of Nessie.  The scientific community considers the monster as a modern-day myth and explains sightings as misidentifications of more mundane objects, […]

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Safety of electronic cigarettes and the Loch Ness Monster

This is the famous “Surgeon’s Photograph,” showing a monster that allegedly lives in the lake Loch Ness in Scotland and is often cheerfully called by its nickname, Nessie. Despite this picture and several pretended sightings, there is no genuine evidence for the existence of Nessie.  The scientific community considers the monster as a modern-day myth and explains sightings as misidentifications of more mundane objects, […]

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E-cigarette TV ads reaching more kids, teens, study finds

Lindsay LowePosted: Tuesday, June 3, 2014, 8:29 AM Cigarette advertisements have been banned from American TV since 1970, but e-cigarette commercials are now targeting an increasing number of kids and young adults.That’s according to a new study, printed in the journal Pediatrics, which found a dramatic increase in the number of e-cigarette commercials airing on young-adult-friendly networks including Comedy Central and VH1.In fact, the number of e-cigarette ads that reached children increased over twofold since 2011, and around 80 percent of those ads were for one e-cigarette brand, Blue eCigs.E-cigarettes are battery-powered devices that simulate the experience of smoking by releasing a nicotine vapor.“Researchers have yet to determine the direct health effects posed by inhalation of the vaporized chemical constituents of e-cigarettes,” says Pediatrics, adding, however, that “studies suggest that exposure to nicotine has deleterious effects on the brain during youth and young adulthood.”E-cigarettes could act as a potential gateway to other forms of tobacco, researchers say.“The rise in e-cigarette use among youth aged 12 to 17 years poses several concerns,” the study states. “E-cigarette use may lead to tobacco use, undermine social norms about tobacco, and delay cessation among cigarette smokers. It is unknown whether e-cigarette use increases youth risk for nicotine addiction or serves as a gateway, increasing risks that youth will transition to using other tobacco products.”What do you think about e-cigarette ads appearing on youth-friendly TV networks? Tell us in the comments!View the original at Parade or follow us on Twitter, Facebook or Google+Original author: Luisa
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Northampton Board of Health Positions Itself for Hypocrite of Year Award

Last week, the Northampton (MA) Board of Health enacted regulations to strengthen its smoke-free air law. Specifically, the Board of Health extended the smoking ban to include: (1) all public parks and athletic fields; (2) all private clubs; and (3) the use of e-cigarettes in all public places, including parks.It may sound like a strong, courageous action from a Board of Health that is being guided by the solid, consistent principle that all nonsmokers should be protected from exposure to secondhand smoke, period.The Rest of the StoryNot exactly.While the Board of Health was "courageous" enough to ban smoking at all private clubs, it was not "courageous" enough to similarly ban smoking at the city's own public club -- the Garden House Banquet Hall at Look Park.Hidden in the regulations is an exemption that allows for a designated smoking area at the Garden House Banquet Hall, even though that area is located in Look Park, which is a municipal park at which the regulations supposedly ban smoking.In other words, this is a special exemption put in place for what are clearly political, rather than public health purposes.And what might those political purposes be?Well, consider that by banning smoking at all private clubs but creating an exemption for the city's Banquet Hall, it could potentially establish a competitive advantage for the city-owned facility over private facilities in competition for business from people looking for venues for celebrations.Fortunately, the fine print in the regulations did not escape the attention of the ACLU, which is challenging this special interest exemption.The ACLU is also challenging the inclusion of electronic cigarettes in the regulations, as it seems absurd to ban the use of e-cigarettes in all parks, given the lack of any evidence that vaping in a park poses any substantial public health threat.The Northampton Board of Health may not have created public health regulations that have any consistency or science base. However, they have created an excellent entry for the 2014 Hypocrisy of the Year Award.Original author: Michael Siegel
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New Jersey GASP Pushing Legislation that Would Ban Electronic Cigarette Use on Every State Beach, But Allow Casino Workers to Inhale Huge Amounts of Secondhand Smoke to Make a Living

Do anti-smoking groups have any sense of perspective? The answer appears to be "no" based on the latest news out of the Garden State.New Jersey GASP is pushing for state legislation that would ban smoking everywhere on college campuses, including in remote alleys and parking lots and would ban electronic cigarette use on a remote area of a beach, but allow smoking to continue unencumbered in crowded Atlantic City casinos, where hundreds of workers are suffering debilitating diseases because of their secondhand smoke exposure.According to a NJTV News article: "More towns are banning smoking at the beach in New Jersey. Global Advisors on Smokefree Policy (GASP) Executive Director Karen Blumenfeld told NJTV News Managing Editor Mike Schneider that GASP really wants a 100 percent smoke-free environment in public places." The Rest of the StoryGASP may want a 100% smoke-free environment in public places, but it said nothing in the entire news interview about the real public health problem in New Jersey: secondhand smoke exposure in the state's casinos. Moreover, while GASP is promoting legislation to get rid of every last wisp of smoke on entire college campuses and to ban electronic cigarette use in remote areas of a beach, the legislation that the group is supporting allows smoking to continue unabated in the state's casinos, where hundreds of workers are suffering from real diseases brought on by secondhand smoke exposure.Were I a casino worker in New Jersey, I would be pissed off that GASP is supporting legislation to protect the public from the imaginary public health threat of deadly secondhand smoke exposure on beaches and in college parking lots, while that very legislation does nothing to protect me from the very real threat I face every day from the devastating effects of 40 hours or more per week of high levels of secondhand smoke exposure.According to ANR: "The average level of cotinine (metabolized nicotine) among nonsmokers increased by 456% and the average levels of the carcinogen NNAL increased by 112% after four hours of exposure to secondhand smoke in a smoke-filled casino with a "sophisticated" ventilation system."In contrast, I'm not aware of a single study showing that banning smoking everywhere on college campuses or on beaches is necessary to protect the public from any substantial public health threat.Perhaps I wouldn't be so bothered by this attempt to protect the public from every last wisp of smoke on beaches if state politicians had some integrity and were willing to also protect the state's citizens who need it the most: New Jersey's casino and gaming workers.The rest of the story is that GASP as well as New Jersey politicians who are pretending to show a genuine concern for the public's health are actually showing little but hypocrisy and political cowardice. In 2014, I don't see any need for this kind of public health nonsense.Original author: Michael Siegel
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E-Cigarette Advertising Soars on American TV, Study Finds

June 02, 2014MONDAY, June 2, 2014 (HealthDay News) -- Commercials that promote electronic cigarettes have become a growing presence on American TV, new research finds, with the youth audience for such ads roughly tripling in recent years.The upshot: E-cigarettes are now being pitched to roughly 24 million viewers between the ages of 12 and 24, the study authors said.The findings raise concerns about the promotion and popularity of e-cigarettes, given the range of unanswered questions regarding their safety."The is the first piece of evidence to show exactly how much e-cigarette advertising our youth is seeing," explained study author Jennifer Duke, a senior research public health analyst with RTI International in Research Triangle Park, N.C. "And what we found is that while in 2010 e-cigarette advertising on TV was very limited, the increase since that time has been very dramatic.""Now, the manufacturers say that they are not targeting youth," Duke noted. "But the truth is that it's impossible on a medium like TV to increase ad exposure to this degree and not increase exposure to youth. And it's also clear that the increase in advertising is specifically happening on shows and cable networks that are very popular with youth."Duke and her colleagues report their findings online June 2 and in the July print issue of Pediatrics.Duke pointed out that while TV advertising for traditional cigarettes has been banned since 1971, the U.S. Food and Drug Administration only regulates e-cigarettes when they are specifically marketed as smoking-cessation devices.The FDA in April proposed long-awaited regulations governing the fast-growing electronic cigarette industry.The new rules would give the FDA the authority to regulate e-cigarettes as tobacco products, placing them under the same requirements as cigarettes. That would include a ban on the sale to minors.E-cigarettes are essentially nicotine-delivery systems that rely on battery-powered heating mechanisms to vaporize chemicals for easy inhaling. And although e-cigarettes are usually designed to mimic the appearance of a traditional cigarette, they are distinguished by a smokeless environment that does away with the need for burning tobacco.Federal health experts caution that the safety of e-cigarettes remains unclear until more rigorous studies are conducted. And they stress that the absence of toxic combustion does nothing to undercut the highly addictive nature of nicotine itself. Nor is it yet clear what level of threat may be posed by other carcinogenic chemicals commonly found in e-cigarette vapor.To evaluate current e-cigarette advertising trends on TV, the study authors reviewed information provided by Nielsen, the main collector of TV advertising data.Focusing on the years 2011 through 2013, the study team tracked all the e-cigarette advertisements that aired on more than 100 network and cable channels across 210 different markets.The result: the number of children between 12 and 17 who were exposed to e-cigarette ads on TV rose more than 250 percent between 2011 and 2013.Among young adults between 18 and 24, that increase amounted to more than 320 percent.More than three-quarters of the ads were airing on networks known to be popular with young people, including Comedy Central, TV Land, WGN America, VH1, Country Music Television and AMC."I would say that we don't know what exposure to e-cigarettes will do over time," Duke acknowledged. "We don't yet know if they are a pathway to use of traditional cigarettes themselves. But we do know the negative effect nicotine has on brain development among youth. So it's a real concern. And given the potential dangers, I certainly think the FDA should regulate images of e-cigarettes on TV and other places where they do advertising, just as they already do for regular cigarettes."Dr. Norman Edelman, senior medical advisor for the American Lung Association, said that growth in e-cigarette advertising isn't particularly surprising."As e-cigs enter the 'mainstream' and are produced by bigger manufacturers, they are more likely to be promoted by the more expensive but more widely accessed major media, such as cable TV," he said. "[And] there seems little doubt that the makers will consider teenage children as a major market and will market to them, albeit indirectly by indicating that they are 'for adults.' "Edelman said the attempt to place e-cigarettes before a wide audience of young Americans is a troublesome development."There is little doubt that inhalation of nicotine embedded in chemically active vapor vehicles causes at least some harm," he added. "Whether it causes as much harm as tobacco smoke is a complex and unresolved question, which might be relevant to adult smokers. However, it is not relevant for children, who will not use the device as a replacement for tobacco smoke but as an initiation to nicotine inhalation -- a highly addictive substance with deleterious biologic effects in the doses associated with e-cigs.""Clearly it is important that we develop policies to protect children from this potential threat," Edelman said.More informationFor more information on e-cigarettes, visit the U.S. National Institute on Drug Abuse.Copyright © 2014 HealthDay. All rights reserved.SOURCES: Jennifer Duke, Ph.D., senior research public health analyst, RTI International, Research Triangle Park, N.C.; Norman Edelman, M.D., senior medical advisor, American Lung Association; July 2014 Pediatrics...Original author: Maximus
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How to switch from tobacco to electronic cigarettes?

This post is based on personal experience and hearsay rather than scientific evidence. Many years of interaction with successful and less successful users of electronic cigarettes make me believe in certain prerequisites for an effective switch from tobacco smoking to the inhalation of nicotine containing vapor. It is a pity to watch people giving up electronic […]

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How to switch from tobacco to electronic cigarettes?

This post is based on personal experience and hearsay rather than scientific evidence. Many years of interaction with successful and less successful users of electronic cigarettes make me believe in certain prerequisites for an effective switch from tobacco smoking to the inhalation of nicotine containing vapor. It is a pity to watch people giving up electronic […]

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Electronic cigarettes and nicotine poisoning

In view of the established toxic effects of nicotine, the widespread  availability of nicotine containing liquids used to refill electronic cigarettes may pose a certain health risk, and even fatal outcomes of nicotine poisoning have been predicted by some public health advocates. Here I won’t talk about deliberate misuse by e.g. intravenous injection of nicotine containing solutions […]

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Electronic cigarettes and nicotine poisoning

In view of the established toxic effects of nicotine, the widespread  availability of nicotine containing liquids used to refill electronic cigarettes may pose a certain health risk, and even fatal outcomes of nicotine poisoning have been predicted by some public health advocates. Here I won’t talk about deliberate misuse by e.g. intravenous injection of nicotine containing solutions […]

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Pfizer Publicly Undermines and Refutes Black Box Warning for Chantix; Should Face Penalties or Removal of Drug from Market

The black box warning for Chantix, which is required by the FDA to be placed on this smoking cessation drug made by Pfizer, notes the following:"All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide, have been reported in some patients attempting to quit smoking while taking CHANTIX in the postmarketing experience. ... Advise patients and caregivers that the patient should stop taking CHANTIX and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior."The black box warning, then, advises physicians to observe patients being put on Chantix for "suicide-related events," including "suicide."The requirement by the FDA that this black box warning be placed on Chantix is based on the agency's assessment of hundreds of cases of suicides that occurred in patients who had recently been treated with the drug, as well as thousands of cases of other serious adverse neuropsychiatric symptoms associated with the use of Chantix. In making a decision to require a black box warning, the agency takes into consideration the likelihood that the observed association between the drug and the adverse effects is a causal one.In my opinion, it is the responsibility of the company that markets the drug in question not to undermine, refute, or publicly challenge the black box warning once the FDA has made a decision to require this warning. It is the FDA's scientific judgment, not that of the pharmaceutical company, that should be the final word in making the decision about whether or not a black box warning is required and what the black box warning should state. If the company refutes the black box warning publicly once it has been required, then it is essentially thumbing its nose at the FDA and substituting its own scientific judgment for that of the agency.The Rest of the StoryResponding to a news media request for a quote regarding a murder/attempted suicide case in which the defendant claims he acted as a result of depression induced by Chantix, Pfizer publicly refuted the FDA's required black box warning and denied that there is any reliable evidence that Chantix can cause severe neuropsychiatric events, such as suicide or similar violent actions.According to an ABC News article:"Pfizer released a statement defending the smoking cessation medication. “Chantix has been studied extensively and there is no reliable scientific evidence that the medicine causes serious neuropsychiatric events like the violence in this case,” a Pfizer spokesperson told ABC 10 News."In my view, this refutation and undermining of its own black box warning violates accepted standards of pharmaceutical company conduct, and should prompt either penalties or the removal of the drug from the market. If Pfizer is going to publicly undermine the required black box warning, then clearly that warning is not adequate to protect consumers and the FDA must either penalize Pfizer so that it desists from this behavior or pull the drug from the market since it is becoming clear that the company is undermining that warning in the eyes of the public.This is the equivalent of a cigarette company refuting the required warnings that are made on a cigarette package. The cigarette companies are free to fight the cigarette warning labels as they are being considered, but once a federal body requires those warnings, the companies must not act to undermine the required warnings. In this case, Pfizer's actions are more grievous than those of a cigarette company undermining a package warning because the black box warnings are required by a federal regulatory safety agency, rather than by a Congressional act. More specifically, the black box warnings are an official part of the formal approval of the marketing and sale of the drug. The company may not sell the drug without the warning. By publicly undermining and refuting the warning, the company is essentially violating the terms of the drug's approval.Had there been no reliable evidence that Chantix may cause serious neuropsychiatric events like suicide or other violent behavior, then why did the FDA conclude - after reviewing the evidence - that a black box warning is required?And why did the FDA require Pfizer to warn doctors that patients taking the drug should be "observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide ... as well as worsening of pre-existing psychiatric illness and completed suicide."By publicly refuting the black box warning, Pfizer is literally spitting in the face of the FDA. This is not appropriate. The company should either be penalized and forced to discontinue its campaign of refutation of the black box warning findings, or the drug should be pulled from the market due to a finding that the company has violated the terms of the drug's approval.Of course, the FDA is not going to take either of these actions. Because it knows where its bread is buttered. In contrast, however, the very same agency is prepared to pull thousands of electronic cigarettes from the market even though there really is no reliable evidence of any harms being caused by these products (with the exception of exploding batteries, which the agency should immediately address via a manufacturing standard requirement).Original author: Michael Siegel
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The New Joe Camel? E-Cigarette Ads Spook Anti-Smoking Activists

Some anti-smoking advocates fear the rise of a new, battery-powered Joe Camel as researchers find that more young people are being exposed to unregulated electronic cigarette ads mixed in with popular TV shows.More than four decades after President Richard Nixon banned ads for tobacco cigarettes on radio and television, the airwaves are burning up with e-cigarette ads targeted at adolescents and young adults, according to a study published Monday in the journal Pediatrics.“This is what we saw back in the 1960s and 1950s, and the study is deeply concerning to me,” says Matthew Myers, president of the Washington, DC-based Campaign for Tobacco-Free Kids. “Congress banned this (TV ads) precisely because of the unique impact it can have on kids. E-cigarettes are doing the exact same thing.”Researchers from RTI International found that kids aged 12 to 17 experienced a 256 percent increase in exposure to ads touting e-cigs during the study period of 2011 to 2013. The exposure of young adults, those ages 18-24, increased by 321 percent.This Video Player Requires JavaScriptIt has come to our attention that the browser you are using is either not running javascript or out of date. Please enable javascript and/or update your browser if possible.Unlike traditional cigarettes, e-smoke advertising is not federally regulated. The cylindrical vaporizers weren’t around when the big tobacco companies regularly made headlines over their advertising tactics. But now, according to the researchers, marketers are using the power of the small screen to promote various brands, in a similar fashion to what was aired when tobacco was king.“We don’t know the extent to which an e-cigarette is really a gateway to other tobacco products."Today, though, more than 75 percent of e-cig ads were shown on cable networks, including AMC, Country Music Television, Comedy Central, WGN America, TV Land, and VH1. Researchers also found that e-cigarette ads appeared on programs like “The Bachelor,” “Big Brother,” and “Survivor,” all of which were among the 100 highest-rated youth programs for the 2012-2013 TV season. More than 80 percent of the ads were for a single brand, blu eCigs.To figure out just how pervasive e-cigarette TV ads were during the last few years, the researchers used a standard unit of TV exposure measurement called Target Rating Points, or TRPs. These points are measured for a specified audience as a function of an ad’s reach, basically the proportion of people exposed to an advertisement, as well as frequency, or the number of times an advertisement is potentially viewed.This Video Player Requires JavaScriptIt has come to our attention that the browser you are using is either not running javascript or out of date. Please enable javascript and/or update your browser if possible.The researchers used a common measurement to gauge how many people saw an e-cigarette, and how often they likely saw it. Based on that data, they estimated that 50.0 percent of all kids between the ages of 12 to 17 in U.S. TV households were exposed to an average of 21 e-cigarette ads from October 2012 through September 2013.They also say data could represent an exposure to an average of 105 advertisements for 10 percent of all U.S. youth or an exposure to an average of 13 ads for 80% of all U.S. youth over the 1-year period.Those numbers have researchers and other public health advocates worried.“We don’t know the extent to which an e-cigarette is really a gateway to other tobacco products,” explains lead researcher Dr. Jennifer Duke, senior public health analyst at RTI. “What we do know is that nicotine spurs changes in the brain that leads to addiction. And no one knows what the ramifications of e-cigarettes and potential addiction will be.”This Video Player Requires JavaScriptIt has come to our attention that the browser you are using is either not running javascript or out of date. Please enable javascript and/or update your browser if possible.Indeed, e-cigs are growing in popularity, with about $1 billion in sales as of August 2013. As of 2012, an estimated 1.8 million middle and high school students had ever used e-cigarettes, according to the researchers. With tobacco companies like Lorillard, which bought blu eCigs, entering into the mix, makers of e-cigs have gone Hollywood with celebrity endorsers like Jenny McCarthy and Stephen Dorff touting the benefits of blu, and punk queen Courtney Love plugging another brand called NJOYs.For doctors on the frontlines of treating and preventing disease among children and young adults, the prevalence of e-cig use among youth is one more battle they must fight to try and keep kids healthy.“This whole study is tremendously concerning to me,” says pediatrician Dr. Deb Lonzer of Cleveland Clinic Children’s. “Celebrities have enormous power and they are touting the benefits of smoking. I’m just a nerdy little pediatrician, how can I compete with some celebrity or the deep pockets of a tobacco company?”Neuroscientists now recognize that adolescent brains are still developing, and don’t reach full maturity until the early 20s. The last part of the brain to develop includes areas linked to impulse control and planning.“Just because a young person has a cell phone like an adult or holds down a job like an adult does not mean they are adults in terms of a mature brain,” Lonzer said. “That means they can’t make decisions like an adult and when they are exposed repeatedly to things that seem to be the social norm, trust me, they will try those things.”According to a report released by the anti-smoking organization Legacy, e-cig manufacturers spent $39 million in advertising from June through September 2013, much of it targeted to youth. Although some manufacturers would welcome regulation, they do dispute they target America’s young.“The products are being advertised to adults,” said Cynthia Cabrera, executive director of the Smoke Free Alternatives Trade Association. “If children are watching during that time, it’s possible, but they are being marketed to adult consumers, to adult smokers.”NBC News' Maggie Fox contributed to this report.First published May 30 2014, 1:35 PMOriginal author: Luisa
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Viewing E-Cigarette Use May Keep Smokers From Quitting

[unable to retrieve full-text content]Title: Viewing E-Cigarette Use May Keep Smokers From Quitting Category: Health News Created: 5/29/2014 4:36:00 PM Last Editorial Review: 5/30/2014 12:00:00 AMOriginal author: Riley
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Nicotine – the basics

As key component of the vapor inhaled by consumers of electronic cigarettes, nicotine has raised controversy because of its alleged addictive potential and toxic effects. Therefore, I will briefly summarize the chemistry, pharmacology and toxicology of nicotine in the first post of this blog. Some important issues, such as toxicology or addiction/dependence will be discussed in detail later. Chemistry […]

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Nicotine – the basics

As key component of the vapor inhaled by consumers of electronic cigarettes, nicotine has raised controversy because of its alleged addictive potential and toxic effects. Therefore, I will briefly summarize the chemistry, pharmacology and toxicology of nicotine in the first post of this blog. Some important issues, such as toxicology or addiction/dependence will be discussed in detail later. Chemistry […]

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E-cigarette crackdown planned

STORY HIGHLIGHTSE-cigarettes deliver nicotine to the user as a vaporFDA has regulatory authority now only over cigarettes, smokeless tobaccoAge limit to buy e-cigarettes is expected to be 18 when rules are final(CNN) -- The Food and Drug Administration is making another attempt at regulating electronic cigarettes and other tobacco products.On Thursday, the agency proposed rules that call for strict regulation of electronic cigarettes, cigars, pipe tobacco, nicotine gels, water pipe tobacco and hookahs. Currently, only cigarettes, smokeless tobacco and roll-your-own tobacco come under the FDA's regulatory authority.When these recommendations are finalized following a 75-day public comment period, the age limit to buy the products is expected to be at least 18, although individual states could choose to set it higher.Health warnings would also be required, and the sale of the products in vending machines would be prohibited. Initially, the only health warning required for e-cigarettes would be about the potential for addiction to nicotine.Manufacturers would be required to register all their products and ingredients with the FDA. They would be able to market new products only after an FDA review, and they would need to provide scientific evidence before making any direct or implied claims of risk reduction associated with their product.Companies would also no longer be allowed to give out free samples.After the public comment period, and once the proposed rules are finalized, manufacturers will have 24 months to submit applications to allow their products to remain on the market or to submit new product applications.E-cigarettes deliver nicotine to the user as a vapor. They are usually battery-operated and come with a replaceable cartridge that contains liquid nicotine. When heated, the liquid in the cartridge turns into a vapor that's inhaled.Most look like cigarettes, cigars or pipes, but some resemble pens or USB memory sticks. Because they have not been fully studied, the FDA says it's unknown what health risks they pose, how much nicotine or other chemicals are actually being inhaled, or whether there is any benefit to using them.Last year, the Centers for Disease Control and Prevention reported that the percentage of high school students who reported ever using an e-cigarette more than doubled in one year, from 4.7% to 10% between 2011 and 2012.As electronic cigarettes have increased in popularity, so have the number of related calls to poison control centers nationwide. According to a recent CDC report, poison control centers logged 215 calls involving e-cigarettes in February alone. Of those calls, 51% involved children."It's really the wild, wild West out there," said Margaret Hamburg, FDA commissioner. "Because e-cigarettes are increasingly in the marketplace. They're coming in different sizes, shapes and flavors in terms of the nicotine in them, and there's very worrisome data that show that young people in particular are starting to take up e-cigarettes, especially the flavored ones -- and that might be a gateway to other harmful tobacco products."Hamburg said officials don't know how many types are on the market, another reason why regulation is critical."We're already conducting research and working with partners in the research community to better understand patterns of use of these e-cigarettes and to learn more about the way in which they work and the delivery of the nicotine through e-cigarettes. But until we can really regulate them, we can't have all the information we need and we can't take all the actions that we might want to, to be able to best address the public health issues associated with them."Miguel Martin, president of LogicTechnology Development -- considered the second-largest electronic cigarette company in the U.S. -- said he is encouraged by the FDA announcement."We look forward to being a part of this process and believe that science-based and responsible regulations are good for both adult consumers and responsible electronic cigarette manufacturers," Martin said.Logic opened its doors in 2010. The company has nine products on the market, both disposable and rechargeable, but no flavored nicotine products. Logic implemented rules a year ago similar to the ones the FDA has proposed."We support and have already implemented those steps to ensure that adult smokers are the audience and consumer base of our products," Martin said. "We work with the retailers to ensure the product is sold to adult consumers of legal smoking age."Experts have said that e-cigarettes, if properly regulated, could help reduce the number of people who use conventional cigarettes and die of tobacco-related disease.But a lot of unanswered questions remain, according to Michael Eriksen, dean of the School of Public Health at Georgia State University, one of 14 U.S. institutions conducting FDA-funded research on electronic cigarettes.Nicotine is a drug, and poison experts say the concentrated liquid form used in e-cigarettes is highly toxic, even in small doses. It can be inhaled or absorbed through the skin."How concentrated is liquid nicotine? Are there impurities in it? Is it properly handled like a pesticide?" Eriksen asks. "Nicotine is a pesticide, fundamentally, and we take so many precautions about pesticides for our lawns and how to wear gloves. But what precautions do consumers take when they put the nicotine vials in? People treat it (liquid nicotine) as sugar when it's a toxin."Harold Wimmer, president and CEO of the American Lung Association, believes nicotine is highly addictive whether used in a regular cigarette or an e-cigarette.So how safe are e-cigarettes? Hamburg said it's buyer beware."We think that there's a lot of information that needs to be understood about e-cigarettes and their use. We're trying to help provide some of that information through research that we're conducting," she said."But we need the tools that regulation provides to be able to get critical new knowledge about e-cigarettes and to be able to put in place a framework that will protect the American public and potentially e-cigarette users, and really address the issues of what are the health consequences and what are the potential benefits."Hamburg believes these new rules will change the landscape.If the FDA broadens its authority to regulate tobacco products, she said, it will make a major contribution to the health of Americans. But big changes could come slowly."It may be years before much regulation is imposed," said Carl Tobias, a law professor at the University of Richmond. "The lobbying at FDA and Congress will be intense."And some believe the FDA has already waited too long."It is inexcusable that it has taken the FDA and the Administration so long to act," Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said in a statement. "This delay has had serious public health consequences as these unregulated tobacco products have been marketed using tactics and sweet flavors that appeal to kids, and their use has skyrocketed."The FDA and the Administration must now move as quickly as possible to finalize this rule."0Comments »SHARE THISPrintEmailMore sharingRedditStumbleUponDeliciousOriginal author: James
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