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FDA to Announce Ban on Sale of Most Cigarettes in Convenience Stores Due to Addiction of Hundreds of Thousands of Youth to Cigarettes

Tomorrow, the FDA is expected to announce the strictest regulation of cigarettes sales in decades. Spurred by the data showing that nearly 8% of high school students are current cigarette smokers, the FDA will announce that from now on, with just a few exceptions, cigarettes may not be sold in any convenience store or gas station. Online sales of cigarettes will still be allowed, but it will be subject to advanced age verification procedures. The only stores that will be allowed to sell cigarettes without restriction will be those which are only open to adults (or which establish an area that is only open to adults).The FDA said it was forced to take this drastic action because it has evidence that: "a new generation is being addicted to nicotine, and we can’t tolerate that."The tobacco companies intentionally make cigarettes more addictive by adding ammonia to the product, which enhances nicotine absorption. Cigarettes are the most effective known product to deliver nicotine in a pattern that is capable of quickly initiating and then sustaining addiction.According to the CDC, every day more than 3,200 youth smoke their first cigarette. It has been estimated that it only takes four to five cigarettes for a youth to become addicted to smoking. One out of every two long-term addicted smokers will die prematurely, primarily from lung cancer, lung disease, heart disease, stroke, or other cancers. The Rest of the StoryActually, I got it wrong.The FDA is not banning the sale of most cigarettes at convenience stores; it is banning the sale of most fake (electronic) cigarettes at convenience stores.Convenience stores and gas stations can continue to sell real cigarettes - which, despite lower smoking rates, continue to addict a new generation to nicotine - but they will no longer be able to sell electronic cigarettes (with only minor exceptions).Somehow, we have completely lost all sense of public health perspective. Every argument that the FDA is making in justifying a ban on the sale of electronic cigarettes in convenience stores and gas stations applies even more strongly for real tobacco cigarettes: you know, the ones that kill hundreds of thousands of Americans each year. Something is terribly wrong with our sense of perspective when we take the fake cigarettes off the shelf but allow the real ones to remain.So let me attempt to correct this skewed perspective.First, we need to recognize that the problem of youth addiction to electronic cigarettes is not a broad problem of youth becoming addicted to e-cigarettes; it is a very specific and narrow problem of youth becoming addicted to Juul. It is one specific product that is causing the problem.Other than Juul, all other closed system electronic cigarettes do not have high addiction potential because they are actually quite poor at delivering nicotine. Specifically, there is no nicotine spike in the blood, and the nicotine level drops off quite slowly. In contrast, the Juul uses a specially formulated nicotine salt that is absorbed much more rapidly into the bloodstream, and the pattern of blood nicotine levels from Juuling mimics that of a real cigarette. Youth are becoming addicted to nicotine not because they are vaping generally, but because there is an epidemic of Juul use occurring in middle schools and high schools across the nation.However, just four days ago, Juul announced that it would voluntarily stop selling flavored Juul products in all convenience stores and gas stations. In fact, Juul has agreed to stop selling flavored Juul products in any brick-and-mortar establishment. These products will only be available online and with age verification procedures.So this sweeping action by the FDA is not necessary. It will not result in the elimination of flavored Juul sales from convenience stores because that is already occurring.So the rest of the story is that what the FDA's action is doing is to make it much more difficult for adults who have quit smoking to continue to stay smoke-free using their favorite brands of electronic cigarettes, which will be taken off the shelves. Youth will not be able to purchase flavored Juul products from stores, but that was going to happen anyway. The other e-cigarettes that are being sold at these stores (i.e., products other than Juul) have low nicotine addiction potential. It makes no sense to take them off the shelves but to allow real cigarettes, which have extremely high addiction potential, to remain available for sale and distribution to the 3,200 youth who try these products every day.I believe this action will have a net negative impact on the public's health because it will almost certainly result in many ex-smokers returning to smoking as their products disappear from convenience store shelves.What the FDA should have done is to deal directly with Juul and demand that they voluntarily remove their flavored products from the shelf and bolster their age verification procedures for online purchases. But since Juul has already agreed to this, there is no need for this drastic regulation, especially because cigarette sales are being left unencumbered.One might argue that the reason that Juul agreed to remove their flavored products from the shelf is that they anticipated this FDA regulation. If that is the case, then perhaps the threat of regulation was successful in achieving this result. But now that Juul has agreed to take most of their products off the shelves, the FDA should not proceed with the regulation. Unless it is sincerely concerned about youth becoming addicted to nicotine, in which case it should ban all cigarette sales in brick-and-mortar establishments that are not restricted to adults.Original author: Michael Siegel
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Peer review of: Linda Johnson et al. (Washington U med school), E-cigarette Usage Is Associated with Increased Past 12 Month Quit Attempts and Successful Smoking Cessation in Two U.S. Population-based Surveys, NTR 2018.

by Carl V Phillips

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Do vapers have an obligation?

by Carl V Phillips

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An overlooked lesson from Glantz harassment and fraud cases: tobacco is way out of FDA’s skill-set

by Carl V Phillips

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Peer review of: Michal Stoklosa (American Cancer Society), No surge in illicit cigarettes after implementation of menthol ban in Nova Scotia, Tobacco Control 2018

For an explanation of what this post is, please see this brief footnote post.

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Peer review of: Dunbar et al. (Rand Corp), Disentangling Within- and Between-Person Effects of Shared Risk Factors on E-cigarette and Cigarette Use Trajectories From Late Adolescence to Young Adulthood, Nicotine & Tobacco Research, 2018

by Carl V Phillips

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Footnote: Paper review posts

This is a prepositioned footnote to explain a series of posts I will be publishing.

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Glantz settles academic fraud and sexual harassment lawsuit

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by Carl V Phillips

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Public health publishing is fundamentally unserious: evidence from a single measure of area

by Carl V Phillips

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Sunday Science Lesson: Calling vaping/tobacco use an “epidemic”: it’s even stupider than you might think

by Carl V Phillips

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Science lesson: The absurdity of “n deaths per year” and “leading preventable cause” claims about smoking.

by Carl V Phillips

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A subtle tobacco control self-contradiction lie, re FDA pumping cigarette stock prices

by Carl V Phillips

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All people like better products. Teenagers are people. Therefore….

by Carl V Phillips

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Let’s try to get our criticisms right, shall we? (More on the recent “vaping causes heart attack” study)

by Carl V Phillips

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Dual use and the arithmetic of combining relative risks

by Carl V Phillips

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A balanced view of ad hominem judgments

by Carl V Phillips

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USC Ended Partnership with Anheuser-Busch InBev in April; Ohio State and San Diego State Should Follow Suit

I have been informed by the USC Suzanne Dworak-Peck School of Social Work that the School and its research team that had been involved in the Smart Drinking Goals project terminated its involvement with the project in April 2018 and that they are no longer associated in any way with the project.The USC team had prepared toolkits summarizing the best current scientific thinking regarding environmental strategies for alcohol prevention. Although the team's involvement was apparently slated to last at least through 2018, they terminated their involvement in April and have completely disassociated themselves from the Smart Drinking Goals project.I applaud USC and this research team for dissociating from the project.The Rest of the StoryTo the best of my knowledge, the Ohio State University is still involved with the Smart Drinking Goals program, and in addition, since yesterday I have learned that San Diego State University also seems to be involved with the program. Both of these institutions should immediately follow the lead and example set by USC and terminate their involvement with this project and their partnership with Anheuser-Busch InBev.While public-private partnerships are sometimes tenable, in this case, you cannot have a credible partnership when the private corporation is bullying and disrespecting the autonomy of governments to implement their own public health measures to prevent excessive alcohol use and its associated harms. I cannot fathom an academic institution partnering with a company that went so far as to threaten a lawsuit against the city of Rostov in order to force it to allow the sale of beer at the World Cup soccer matches in Rostov Arena. Obviously, this completely undermines the supposed "smart drinking goals" initiative and exposes it for what it really is: a public relations hoax.I have since learned that San Diego State University has apparently also partnered with Anheuser-Busch InBev to aid this public relations initiative. According to the university, it accepted a $200,000 grant from the alcohol corporation to be a part of the "implementation planning" for the Smart Drinking Goals project.This grant completely exposes the hypocrisy of the alcohol company and demonstrates why this whole project is a hoax. Ironically, part of the San Diego State University project is to develop programs to reduce excessive alcohol consumption in sports arenas! Now you can see why this is a complete joke. At the same time that the company is, out of one side of its mouth, proclaiming that it cares about reducing alcohol consumption at sports arenas, from the other side of its mouth it is threatening to sue cities in order to force them to sell alcohol and facilitate excessive alcohol consumption in their sports arenas!This hypocrisy boggles the mind, and it demonstrates that the Smart Drinking Goals program is not a sincere effort to address public health concerns but instead, a public relations hoax.Hopefully, Ohio State and San Diego State will follow the example set by USC and immediately terminate their partnerships with Anheuser-Busch InBev.Original author: Michael Siegel
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Anheuser-Busch InBev Proves that Its Smart Drinking Goals Program is a Complete Hoax: Ohio State and USC Have Fallen Prey

Two years ago, I explained why I think Anheuser-Busch InBev's Smart Drinking Goals program is a complete farce. Last year, I criticized the NIAAA for endorsing the alcohol industry's Smart Drinking Goals program. Today, I will show how Anheuser-Busch itself has proven that its Smart Drinking Goals program is a huge hoax, designed solely as a public relations ploy and devoid of any sincere intent to reduce alcohol consumption.For brief background, senior employees of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) appeared in an Anheuser-Busch InBev promotional video that was designed primarily to serve the company's public relations interests. The video was brought to light in an article by Miriam Shuchman at Wired. In the video, Anheuser-Busch InBev boasts to the public about its "Smart Drinking Goals" program, which is purportedly designed to reduce "hazardous" drinking. Several Anheuser-Busch executives-- including its CEO, Chief "Health" Officer, and Chief Legal and Financial Officer--appear in the video, boasting about how wonderful this program is and implying how great a company Anheuser-Busch is for funding this program and how much it cares about the public's health.But the Anheuser-Busch executives aren't the only ones who appear in this promotional, public relations video. Shockingly, this Anheuser-Busch PR effort (i.e., public relations effort) is also endorsed and promoted by senior officials of the Executive Branch of the United States government. And even worse, those senior officials are the Director and the Director of Global Alcohol Research of the NIAAA!The Director of Global Alcohol Research at NIAAA provides a glowing endorsement of the program, describing it as "wonderful" (see 0:27-0:34 in the video). The Director of NIAAA also endorses the program, asserting that it will "go far in moving the field forward" (see 3:17-3:26).However, the true purpose of the video is revealed at 3:42, when an Anheuser-Busch Global Advisory Council reveals the company's aspiration: "We're no longer a neighborhood's beer or a country's beer. We're in fact a corporation representing the world."The video is clearly marketing Budweiser and other beers produced by Anheuser-Busch. As the company acknowledges, they are running this international program because they don't just want to be a neighborhood's beer or a country's beer; they want to be the world's beer. The Rest of the StoryAccording to a Mother Jones article published last Friday, in 2005, Russia took a major public health step by banning the sale of alcohol in sports stadiums. When Russia bid to host this year's soccer World Cup, FIFA insisted that the country repeal its ban on alcohol consumption in stadiums as a condition of hosting the World Cup. Russia complied by creating an exemption from the law. However, earlier this year the city of Rostov (home to one of the stadiums being used for World Cup competition) passed its own law that prohibited the sale of alcohol at Rostov Arena (it did this by declaring the stadium a place of "mass gathering," thus removing the exemption from the national ban.The city of Rostov thus exercised its right as a sovereign local government to protect the health and safety of its citizens by preventing alcohol sales at Rostov Arena, which could fuel violence, especially in the setting of international soccer competition. The policy was evidence-based, as there have been numerous episodes of violence fueled by the sale of alcohol at such matches.Rather than respecting the autonomy of the Rostov government, Anheuser-Busch InBev threatened to sue Rostov city authorities. There is obviously no legitimate legal grounds for such a lawsuit. Rostov certainly has the legal authority to enact reasonable measures to protect the health, safety, and security of the public. Nevertheless, Anheuser-Busch InBev threatened the lawsuit in order to try to intimidate Rostov. It worked. The city backed down.These actions of Anheuser-Busch InBev are not those of a company that has any interest in protecting the public's health. They are the actions of a bully corporation that puts the sale and consumption of its products above the public health, public safety, and even the autonomy of local government bodies.In light of this action, the Smart Drinking Goals program cannot be taken seriously. It is purely a public relations ploy. While I don't blame the company for designing this clever marketing scheme because it's job is to sell alcohol, I do blame the NIAAA for endorsing the scheme, and I also blame the universities that have agreed to participate in the scheme by serving as partners.Specifically, I denounce the Ohio State University, the University of Southern California, and investigators at both institutions for accepting what appears to be more than $1 million to partner with Anheuser-Busch and help serve as implementation planning and technical assistance sites for the Smart Drinking Goals program.By doing this, Ohio State and USC are participating in a marketing ploy of the company. Essentially, Ohio State and USC are helping Anheuser-Busch to market beer and achieve its goal of becoming the world's beer. These universities are acting as essentially a marketing branch for Anheuser-Busch. With the promotion of Anheuser-Busch's interests that Ohio State and USC are providing, the company hardly needs its own marketing division. It can simply call Ohio State and USC its de facto Marketing and Public Relations Department.It appears that Anheuser-Busch InBev's implementation partnerships are with the College of Social Work at the Ohio State University and School of Social Work at USC. The grant appears to be primarily with Ohio State University; however, since the principal investigator recently moved from Ohio State to USC, both institutions are now involved. The co-principal investigator of the project, who is at Ohio State, reports Anheuser-Busch funding in the amount of $946,517. The amount of funding to the principal investigator, who is at USC, is not clear.I can see how researchers can be easily deceived by the clever scheme of this leading international alcohol corporation. Offers of money, especially for academic researchers like me, can easily distort our judgment. As the tobacco industry has proven, researchers and universities can essentially be bought out. The tobacco industry used this strategy to its great advantage.But in some ways, this is worse than universities accepting tobacco money for research. Here, the universities are accepting money to actually be a part of the implementation of this alcohol company initiative. By doing so, they become co-conspirators. This is why I refer to them as participating in this public relations ploy.If Anheuser-Busch InBev was sincere about wanting people to reduce their alcohol consumption, it would not bully city authorities like those in Rostov and essentially force them to allow the sale of alcohol at mass public events where there is a legitimate concern for public safety. It would not disrespect the autonomy of a local government to implement its own public health and safety laws.The rest of the story is that this is not a company that public health (and social work) researchers and institutions should be collaborating with. Believe me, Anheuser-Busch is successful enough in its marketing and public relations on its own. It doesn't need help from respected academic institutions that are supposed to be in the business of saving lives and improving health, not marketing a dangerous product.What business does a school of social work have partnering with a company that insists upon destroying the autonomy of communities and forcing them to serve alcohol at an event for which the sale of alcohol creates a substantial safety and security risk? Is this the type of company that Ohio State's and USC's social work schools want to be teaming up with?Just as the NIAAA renounced its funding by the alcohol companies for research after the issue was brought to public attention, I hope that Ohio State and USC will also cancel their funding from Anheuser-Busch InBev and avoid the negative publicity that is sure to follow from any continued association with an industry that is preying upon communities and their leaders in order to force them to sell beer in a situation that creates a great risk of violence to their citizens.UPDATE (June 18, 2018 - 7:50 am): I have been informed by the USC Suzanne Dworak-Peck School of Social Work that the School and its research team that had been involved in the Smart Drinking Goals project terminated its involvement with the project in April 2018 and that they are no longer associated in any way with the project.The USC team had prepared toolkits summarizing the best current scientific thinking regarding environmental strategies for alcohol prevention. Although the team's involvement was apparently slated to last at least through 2018, they terminated their involvement in April and have completely disassociated themselves from the Smart Drinking Goals project.I applaud USC and this research team for dissociating from the project.Original author: Michael Siegel
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NIH Disbands Alcohol Clinical Trial Because of Scientific and Ethical Breaches

In a decision that I applaud, NIH Director Dr. Francis Collins announced yesterday that based on the recommendation of his Advisory Committee after an extensive investigation, he is discontinuing the MACH15 (Moderate Alcohol and Cardiovascular Health) clinical trial of moderate alcohol consumption (see original news reports here and here).In its report, the NIH Advisory Committee to the Director concluded as follows:"To understand the context that led NIAAA to embark on the MACH trial, the ACD WG considered the nature and extent of interactions among NIAAA staff, select extramural investigators, and industry representatives before FNIH received approval to secure funding to support the trial. There was early and frequent engagement among these parties which appear to be an attempt to persuade industry to support the project. Several members of NIAAA staff kept key facts hidden from other institute staff members and the FNIH. The nature of the engagement with industry representatives calls into question the impartiality of the process and thus, casts doubt that the scientific knowledge gained from the study would be actionable or believable.""There were sustained interactions between the eventual principal investigator of the MACH trial and members of the NIAAA leadership prior to and during the development of FOAs for planning and main grants to fund the program. These interactions appear to have provided the eventual principal investigator with a competitive advantage not available to other applicants, and effectively steered funding to this investigator.""Interactions among several NIAAA staff and industry representatives appear to intentionally bias the framing of the scientific premise in the direction of demonstrating a beneficial health effect of moderate alcohol consumption. Independent review of the trial plan raised concerns that there are insufficient patients and not enough follow-up time to allow for meaningful assessment of cancer endpoints. The composite primary endpoint does not include heart failure. Thus, the trial could show benefits while missing harms."As a result, the Committee recommended that:"The MACH trial be terminated.""The NIH should examine additional measures to prevent NIH staff from soliciting external funding to support programs.""NIH Institutes, Centers, and Offices (ICOs) should ensure that program staff do not inappropriately provide non-public information, or engage in deliberations that either give the appearance of, or provide, an advantage to any single, or subset of, investigator(s)."The Rest of the StoryI want to thank all the individuals and organizations who helped bring this to the attention of the NIH director and the DHHS Inspector General and who have been working to maintain a high level of scientific and ethical integrity at the NIAAA, especially my colleagues Dr. David Jernigan, Dr. Rich Saitz, Dr. Tim Naimi, Dr. Ziming Xuan, and Dr. David Rosenbloom here at the Boston University School of Public Health; Dr. Tom Babor at UCONN Health; Dr. Jim Sargent at Dartmouth's Geisel School of Medicine; Dr. Michael Carome and Public Citizen; Bruce Livingston and Carson Benowitz-Fredericks and Alcohol Justice; Diane Riibe and the Alcohol Policy Alliance; Dr. Thomas Hilton, former NIH science officer; Dr. Josh Sharfstein at the Johns Hopkins Bloomberg School of Public Health; Jennifer Grodsky at BU Federal Relations; Senator Edward Markey and his outstanding staff; the minority staff of the House Energy & Commerce Subcommittee on Oversight and Investigations; and Representative Lucille Roybal-Allard and her amazing staff.And also, my sincere thanks and appreciation to the investigative reporters who helped shed sunlight (the best disinfectant, according to Justice Louis Brandeis) on what was going on behind the scenes, especially Roni Caryn Rabin at the New York Times who blew open the most important aspect of the story -- the secret meetings between NIAAA officials and alcohol industry executives in which the future principal investigator and NIAAA solicited funding from the alcohol industry. This was the revelation that led to the NIH director's investigation that ultimately led to the termination of the study.Thanks also to Sharon Begley at STAT News; Stephanie Mencimer at Mother Jones, Miriam Shuchman (who wrote an excellent story at Wired); Ed Cara at Gizmodo; Liz Borkowski at The Pump Handle and the George Washington University School of Public Health and Health Services; Beth Mole at Ars Technica; and Shawna Williams at The Scientist.It takes a village -- it certainly did to bring down this scientifically fraudulent and unethical research.Original author: Michael Siegel
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Alcohol Clinical Trial Continues to Crumble: Anheuser-Busch Pulls Its Funding

In another setback for the NIAAA's and alcohol industry's study of the "health benefits" of encouraging people to drink, Anheuser-Busch has pulled its funding from the clinical trial because recent controversy over how the research funding was solicited has undermined the study's credibility.According to an article by Roni Caryn Rabin in the New York Times:"Brewing giant Anheuser-Busch InBev, one of five alcohol companies underwriting a $100 million federal trial on the health benefits of a daily drink, is pulling its funding from the project, saying controversy about the sponsorship threatens to undermine the study’s credibility, the company announced Friday. ... Anheuser-Busch InBev had committed $15.4 million to support the trial, representing nearly one-quarter of the $66 million in funds pledged by beer and liquor companies to date."Last month, the NIH halted the trial while it investigates potential violations of NIH policy committed by the NIAAA in soliciting funding from alcohol companies to conduct the research. Two NIH committees are expected to report on the results of their investigations later this month.The Rest of the StoryThis demonstrates why accepting alcohol industry funding for this research was so inappropriate. Clearly, the alcohol companies are not in it for the science. They are in it for its public relations value. As soon as they perceived that the public relations value for the research deteriorated, they abandoned the research - they couldn't have gotten out of town more quickly.This is why it was wrong to accept alcohol industry funding for this study in the first place. It was tainted from the start. Not only was the scientific objectivity compromised, but the ethical integrity was compromised as well. Essentially, the NIAAA - as well as investigators from Harvard School of Public Health, Johns Hopkins, and Wake Forest University - had agreed to accept money to do the public relations work for these companies. It was never about the science. It was about trying to help the companies sell beer, wine, and liquor.In addition to its double violation of NIH policy (the solicitation of funding from alcohol companies by NIAAA officials and the acceptance of corporate money for a study that would not otherwise have been conducted), its violation of ethical standards (the principal investigator apparently lying about having had contact with the alcohol companies prior to initiating the research), and its violation of scientific integrity (the principal investigator promising the industry positive results and pitching it to the companies based on the public relations value for these companies), the trial had multiple other problems, including a possible violation of federal law, as it is not clear to me that the sponsor had obtained an IND (investigational new drug application) prior to recruiting patients.And I haven't even yet revealed what is perhaps the greatest ethical violation of the study - its failure to adequately inform human subjects of the potential risks of participation in the study. For example, the study recruitment site, in listing the risks of participation in the research, fails to even mention that alcohol consumption increases the risk of cancer, especially breast cancer among women. The study fails to meet the requirements for human subjects protection because it fails to justify exposing women to an increased risk of breast cancer and it fails to demonstrate that the potential benefits outweigh these risks.The study also fails to inform the public (and presumably human subjects as well) that alcohol consumption at the levels required in the study has been associated with an increased overall mortality risk in a recent study.I will be delving into the human subjects protection failures of the research in future commentaries.For now, the most important point is this:The rest of the story is that the NIAAA, Harvard, and the other participating institutions allowed the alcohol companies to use them as part of their public relations and marketing plan to increase the sales of beer, wine, and liquor. The motivation behind their funding of the research was never a purely academic one, and it is this - above all - that rendered the money tainted. Now that the public relations value of the study has been compromised, Anheuser Busch has dropped it as fast as a wide receiver with greased palms. It's going to take a long time for the NIAAA and the participating academic institutions to de-grease themselves from this fiasco.Original author: Michael Siegel
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