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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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American Cancer Society Sees Zero Cancer Risk for Smokeless Tobacco


A June 11th American Cancer Society policy paper (here) states that the Society will “focus on the primary goal of ending deadly combustible tobacco use… Given this imperative, ACS will provide smokers and the public with clear and accurate information available on the absolute and relative health impact of combustible tobacco products, nicotine-based medications, [electronic nicotine delivery systems] and other novel tobacco products…ACS will increase its efforts to guide smokers toward evidence-based cessation options that enable them to quit as quickly as possible and eliminate their exposure to combustible tobacco smoke.” ACS researchers have estimated the number of cancer cases and deaths attributable to potentially modifiable risk factors in the United States (available here).  They identified 17 risk factors causing 660,000 cases of cancer.  Cigarette smoking was the primary cause (responsible for nearly 300,000 cases), while herpes virus type 8 produced the fewest cases (1,040).  Smokeless tobacco was not among the 17 risk factors – a tacit acknowledgment that the risk of cancer from smokeless tobacco is de minimis.  Taking this position, ACS seems to be abandoning its 30-year crusade against tobacco harm reduction. Over the years, I have noted in this blog how ACS failed to provide smokers and the public with clear and accurate information about smokeless tobacco.  Rather, it exaggerated risks (here, hereand here); withheld risk information (here, here, hereand here); and criticized the British Royal College of Physicians’ harm reduction report (here).  ACS describes its new stance on eliminating combustible tobacco use as a “bold new framework for action.”  The policy paper indicates a shift to cautious support of e-cigarettes, conceding that “although the long-term effects of [e-cigarettes] are not known, current-generation [e-cigarettes] are markedly less harmful than combustible tobacco products.” In fact, the long-term effects of smokeless tobacco use are known to be next to nil.  I hope ACS follows with bold new action explicitly acknowledging that dip and chew products are vastly safer than cigarettes.  Original author: Brad Rodu
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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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Johns Hopkins Public Health Researchers Claim that Smoking May Be No More Hazardous than Vaping

In an article published in the Summer 2018 issue of the Hopkins Bloomberg Public Health Magazine, two researchers at the Johns Hopkins Bloomberg School of Public Health are denying that smoking is known to be any more hazardous than vaping.According to the article, Dr. Ana Maria Rule, an assistant professor in the the Department of Environmental Health and Engineering, argued that: "Even if vaping proves safer than smoking, that's still a long way from a gold stamp for their safety." This of course implies that we don't currently know that vaping is any safer than smoking. In turn, this means the professor's claim is that we don't currently know that smoking is any more harmful than vaping.In the same article, Dr. Joanna Cohen, a professor and director of the Institute for Global Tobacco Control, is quoted as stating: "They are likely safer than continuing to smoke combustible cigarettes, but without the long-term studies, we just don’t know." Thus, Dr. Cohen is claiming that we just don't know whether smoking is any more hazardous than vaping.The Rest of the Story This type of denialism is something you might expect from the tobacco industry, not from public health researchers. But ironically, even the tobacco industry hasn't sunk to the level of claiming that their combustible cigarettes, which kill more than 400,000 Americans each year and more than 6 million people worldwide, may be no more hazardous than devices which contain no tobacco and involve no combustion.In fact, all the major tobacco companies have in fact admitted that combustible tobacco products are far more dangerous than non-combusted products that don't even contain any tobacco. And even Dr. Stan Glantz, who is about as opposed to e-cigarettes as one can be, acknowledges that e-cigarettes are safer than real ones. Perhaps more objectively, the National Academy of Sciences stated that there is "conclusive evidence" that vaping is safer than smoking.What almost nobody in tobacco control is acknowledging is that most of the major brands of electronic cigarettes that are sold at retail stores in the U.S. and which account for well over half of the market share have been tested and no detectable levels of any dangerous chemicals have been identified in the aerosol. This includes the major cigarette company brands, such as Mark Ten and Vuse, as well as Juul and several other leading brands made by the largest independent vape manufacturers. With these brands, even the potential health effects we are talking about are mild, acute respiratory and cardiovascular irritation. There is no evidence that vapers are exposed continuously enough for these acute changes to result in chronic lung or heart disease, but even if the risk is slightly increased, there is no way that it could equate to the risks of active smoking.The problem with this denialism is not merely that it is spreading misinformation. The problem is that this is exactly the kind of false propaganda that is deterring many smokers from trying to quit smoking using vaping products and is causing some ex-smokers to return to smoking. If we aren't sure that vaping is any safer than smoking, then why bother quitting smoking using e-cigarettes? You might as well just keep on smoking. And if you've already quit using e-cigarettes, then what's the point of staying on e-cigarettes? Why not just go back to smoking, since we're not sure that it's any more dangerous than vaping?If a physician were to give the same advice to a patient, it would be grounds for malpractice. Can you imagine doctors discouraging their smoking patients from switching to e-cigarettes because they are not sure it is any safer? Can you imagine doctors telling ex-smoking patients that they might as well resume smoking because they're not sure that their vaping is any better for their health than smoking?Whether they realize it or not, this is precisely the effect statements like those being made by these Johns Hopkins researchers are having on the public. In fact, several national surveys have demonstrated that the public is largely misinformed about the relative hazards of smoking vs. vaping.  And it is this misperception that has stunted what otherwise could have been a much more substantial shift from smoking to vaping in this country. In other words, this isn't just a question of misleading the public. It's a question of saving lives, or failing to do so.Hopefully, these researchers will publish a correction or retraction of these claims so that we can begin the process of restoring some semblance of a science base in the field of tobacco control.Original author: Michael Siegel
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FDA Aims at Wrong Target in Effort to Protect Teens


FDA Commissioner Scott Gottlieb has again mistakenly blamed e-cigarette companies for teen vaping.  Addressing the American Society of Clinical Oncology, Dr. Gottlieb issued a direct threat: “They better step up and step up soon – to address these trends along with us.  So far, I must say, I’ve mostly been disappointed by the tepid response from companies that know that a meaningful portion of their sales are being derived from kids.  The e-cig companies have a chance to do something about it.  The window is open. But it won’t be open for very long.” (here)  The commissioner also tweeted about “additional regulatory policy measures and new enforcement actions as part of our ongoing campaign.” (here)  FDA survey data show that Dr. Gottlieb’s concern is misplaced.  The charge that “a meaningful portion” of e-cigarette sales are made to children is undermined by a 2014 FDA survey: of 12.9 million adult (here) and 770,000 teen current e-cig users (here), only 9.9% of teens had bought their own e-cigs.  The 76,000 teens who purchased products from retailers accounted for only 0.5% of all users and an even smaller fraction of all sales.  The fact that over 90% of teens obtained e-cigarettes from social sources, such as friends or family, makes “policy measures and new enforcement actions” against retailers entirely misguided.  It is illogical for the FDA to hold retailers responsible for teen e-cigarette use.  The federal government has pursued the elimination of tobacco sales to children for decades.  Beginning in 1997, Washington required states to report underage sales via the Synar Program (here).  The latest Synar data shows that 9.6% of retailers were noncompliant in 2013.  The FDA also conducts compliance checks of tobacco retailers.  In 2016, the FDA reported a noncompliance rate of 11% (here).  The FDA should focus on this far more dangerous illegal cigarette sales issue, rather than obsessing over e-cigarettes.  Bad actors – that small percentage of retailers who sell e-cigarettes to children – should be punished, but their infractions should not cause the entire vaping industry to suffer undue, overly broad sanctions. Were government officials to truly prioritize teen safety issues, alcohol would be their number one target.  One-third of high school seniors drank in the past 30 days last year, and nearly 1 out of 5 were drunk (here), even though the legal age for alcohol purchase is 21.   Demonizing e-cigarettes and their marketers and retailers may generate easy headlines, but real public health gains require data-based prioritization of threats, and for teens, those are alcohol and cigarettes. Original author: Brad Rodu
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Smoking Cessation Clinical Trials…and Tribulations


The medical establishment has transformed a behavior, cigarette smoking, into a disease, and now defines how smoking should be “treated” and “cured”. The ramifications of this scheme were laid bare last week in a New England Journal of Medicine report on a smoking cessation clinical trial (here).  The article, “A Pragmatic Trial of E-Cigarettes, Incentives, and Drugs for Smoking Cessation,” demonstrated one important fact:Clinical trials are awful for assessing human behaviors and preferences like smoking.The authors, mostly from the University of Pennsylvania, enrolled 6,006 smokers employed at 54 companies and gave them “usual care”, consisting of wellness website links and information about the National Cancer Institute’s free text-messaging program, plus one of four “treatments”:1.     Free medicines, including nicotine, bupropion and varenicline, plus free e-cigarettes “if standard therapies failed;”2.     Free NJOY e-cigarettes;3.     A reward of up to $600 if smokers stayed abstinent, plus number 2 above; or,4.     A deposit account up to $600, plus number 2 above.Here are the results:.nobr br { display: none } td { text-align: center} “Treatment” Groups and Successful Quitting at 6 MonthsTreatment (number)Number (%) of Successful QuittersUsual Care (813)1 (0.1%)Free Medicines (1,588)8 (0.5%)Free E-cigarettes (1,199)12 (1.0%)$600 Reward (1,198)24 (2.0%)$600 Deposit (1,208)35 (2.9%)All (6,006)80 (1.3%)In all, only 1.3% of smokers quit, ranging from 0.1% with usual care, to 2-3% for those given financial incentives.  In the study, which lasted only six months, the best “treatment” had a 97% failure rate.  After a full year, the standard period for such trials, one could expect percentages to be even lower.  While the futility of using clinical trials to gauge smoking cessation has been demonstrated repeatedly, medical research and regulatory authorities still demand clinical trial proof – the medical treatment standard – for the benefits of switching from combustible cigarettes to smoke-free products.  Just as common sense tells us that a hammer can’t be used to fasten a screw, the medical community should acknowledge that clinical trials can’t be used to assess smoking cessation. The reason is simple: smoking is not a disease.  Most smokers don’t want treatment, cure, nagging or ostracism. They want information about the full suite of their options, including abstinence and all forms of tobacco harm reduction.  In publishing this uninformed study, The New England Journal of Medicine’s authors and editors demonstrate that the illness-treatment-cure model of smoking is erroneous and completely uninformative.  The medical/public health community needs to embrace population evidence from the FDA survey proving that smokers are quitting with e-cigarettes (here). Original author: Brad Rodu
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Kentucky Adopts a Rational Tobacco Tax Plan


Last month, the Kentucky legislature overrode Governor Matt Bevin’s veto and passed HB366 (here), a tax reform bill that increased cigarette excise taxes from $0.60 to $1.10, while leaving taxes on smokeless products unchanged and leaving e-cigarettes with no excise tax. This policy mirrors the tax plan that my research group designed (here) – one endorsed by 16 tobacco research and economic policy experts from across the nation, and by the Pegasus Institute (here).  Watch my interview with Nick Storm of Spectrum News here to learn more. Enacting this plan, legislators rejected demands from anti-tobacco crusaders to double the cigarette tax increase and make vastly safer smokeless and e-cigarettes equally expensive.  One of their spokesmen, Foundation for a Healthy Kentucky president Ben Chandler, had argued, “you’ve got to have the sticker shock…” (here) That reasoning is both insensitive and nonsensical.  Many Kentucky smokers are unable or unwilling to quit tobacco and nicotine entirely.  For them, traditional quit-smoking methods, which strive for nicotine and tobacco abstinence, don’t work.  Our tax plan encourages and incentivizes smokers to quit or switch to less expensive and vastly safer smoke-free tobacco products, including smokeless tobacco and e-cigarettes.  Decades of epidemiologic studies document that the health risks of dipping and chewing tobacco are, at most, a mere two percent of those associated with smoking.  Unlike cigarettes, smokeless tobacco does not cause lung cancer, heart and circulatory diseases or emphysema.  A recent study conducted by federal researchers and experienced epidemiologists found that men who dip or chew tobacco have no excess risk for mouth cancer (here).     Our plan also encourages smokers to switch to e-cigarettes, which already are among the most common – and most successful – quit aids in the U.S. (here).  HB366 contains another provision favoring reduced risk products.  Kentucky excise taxes will be reduced by half for products that are permitted by the FDA to be marketed as “lower risk.”  Reduced risk applications have already been filed with the FDA for three products: IQOS heat sticks, Camel Snus and Copenhagen moist snuff.  Science tells us that all of these are vastly safer than cigarettes.  The question is: When will the FDA acknowledge this indisputable fact? Original author: Brad Rodu
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Tobacco Research Is Not Immune to Scientific Scrutiny


Recently, the authors of a research article on e-cigarettes groundlessly attacked my credentials and academic independence after I noted, in a letter to journal editors, a lack of scientific rigor in their reporting. The article falsely claimed that e-cigarette use caused experimental smokers to become regular smokers.  In response to my critical remarks, the authors made these charges in their own letter to the editors: “This recent comment is another in a long series of letters or comments from Dr. Rodu…in which he has criticized research that is inconsistent with the tobacco industry’s interests in promoting e-cigarettes and smokeless tobacco.” As an academician, I have both authored articles and scrutinized tobacco research for many years, advising journal editors on those occasions when I found factual deficiencies in published articles.  This effort has served the interests of science and the pursuit of truth. Professional medical journals position themselves as platforms for the publication of honest, transparent, reproducible research.  In an effort to identify inaccuracies and other defects, submissions are subjected to review by editors and multiple external authorities who are experts in relevant fields. Over the last 24 years, in addition to my authorship of 54 peer-reviewed articles for medical and scientific journals (here), I have had 11 letters of scientific criticism published in leading journals, linked below.                1.  Rodu B, Cole P.  Excess Mortality in Smokeless Tobacco Users Not Meaningful.  American Journal of Public Health85:118, 1995. 2. Rodu B, Cole P. Smokeless Tobacco and Periodontal Disease. Letters to the Editor. Journal of Dental Research84:1086-1088, 2005. 3. Rodu B, Cole P. A deficient study of smokeless tobacco use and cancer (letter).  International Journal of Cancer 118: 1585, 2005. 4. Rodu B. Snus and the risk of cancer of the mouth, lung, and pancreas.  Lancet 370: 1207, 2007. 5. Rodu B.  Smokeless tobacco: Society response debatable (electronic letter).  CA: A Cancer Journal for Clinicians 2008; 58.  6. Rodu B, Heavner KK.  Errors and omissions in the study of snuff use and hypertension (letter).  Journal of Internal Medicine 265: 507-8, 2009. 7. Rodu B, Heavner KK, Phillips CV.  Snuff use and stroke (letter).  Epidemiology 20: 468-9, 2009. 8. Rodu B.  Dual use (letter).  Nicotine & Tobacco Research 13: 221, 2011. 9. Rodu B, Plurphanswat N, Phillips CV.  Discrepant results for smoking and cessation among electronic cigarette users (letter).  Cancer 2015 Mar 4. doi: 10.1002/cncr.29307. [Epub ahead of print] 10. Rodu B, Phillips CV.  Regarding “Discontinuation of Smokeless Tobacco and Mortality Risk after Myocardial Infarction” (letter).  Circulation 2015 Apr 28;131(17):e422. doi: 10.1161/CIRCULATIONAHA.114.012038. 11. Rodu B.  Re: Smokeless tobacco use and the risk of head and neck cancer: pooled analysis of US studies in the INHANCE consortium.  American Journal of Epidemiology2017  DOI: 10.1093/aje/kwx211 All scientific research should be subjected to rigorous objective review. On those occasions when pre-publication editorial and peer review fail to identify deficiencies, honest criticism should be encouraged and acknowledged by offending publications. Original author: Brad Rodu
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Pediatrics Editors Claim Compliance with – But Instead Violate Publication Ethics Guidelines


In previous blog posts I described how Pediatrics editors refused to retract a fatally flawed study by University of California San Francisco authors (hereand here).  I also described how they allowed publication of unsubstantiated ad hominem attacks, then tried to cover them up by scrubbing the journal website (here).  Carl Phillips afforded the editors a chance to account for their unprofessional actions in an article at The Daily Vaper (here).  They responded by saying that their actions were consistent with the Committee on Publication Ethics (COPE) guidelines for journals.  This is demonstrably false.  The editors violated three of the guidelines (available here). The COPE guidelines say that “Editors are accountable and should take responsibility for everything they publish.”  However, instead of taking responsibility for publishing an ad hominem attack, they simply erased the attack from the Pediatrics website with no retraction or apology (here).  To make matters worse, they also deleted another comment by Bates and colleagues (here), which violated another COPE principle: “Editors should adopt editorial policies that encourage maximum transparency and complete, honest reporting.” Carl Phillips described another instance of zero transparency: “During the dispute over the comments, the editors informed Rodu that they were commissioning an independent ‘expert’ review of the dispute. Clearly there was no genuinely expert review, because that would have concluded that Rodu was right and Chaffee’s comment was nonsense. The editors did not post the review to the comments thread, as they should have, and refused a request by The Daily Vaperto see a copy of it.” Finally, as Phillips and I have documented in detail, the Pediatrics editors violated a third principle: “Editors should guard the integrity of the published record by issuing corrections and retractions when needed and pursuing suspected or alleged research and publication misconduct.” The original manuscript from Benjamin W. Chaffee, Shannon Lea Watkins, and Stanton A. Glantz was never retracted after it was clearly demonstrated to be deficient, and the Pediatricseditors – Drs. Lewis First (University of Vermont), Alex Kemper (Nationwide Children’s Hospital, Columbus Ohio) and Mark Neuman (Harvard) – are guilty of publication misconduct. Original author: Brad Rodu
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E-Cigarette Opponents Still Making Up False "Facts" to Demonize Vaping

We're well into 2018 and there is now substantial research on the health effects of vaping as well as a decade of experience with large numbers of vapers, yet e-cigarette opponents are still making up false claims to buttress their demonization of vaping.In an article by Jia Tolentino published yesterday in the New Yorker, a Harvard professor was quoted as claiming that: "vaping can cause something called bronchiolitis obliterans, or popcorn lung."He also stated that Juul is "a massive public-health disaster," likened e-cigarettes to “bioterrorism,” and "predicted that, eventually, a state’s attorney general would sue Juul 'for willfully designing and pushing a product that will cause harm to the children of the United States.'"The Rest of the StoryWhile he may be able to fool the public, this professor was no match for the likes of Jia Tolentino, who did extensive background research and therefore pointed out that: "Popcorn lung has been linked to diacetyl, an organic compound that some companies use in their e-liquid, and that has been detected as a by-product of e-cigarette vapor. But diacetyl has also been detected in cigarette smoke, at a level hundreds of times greater, and no feasible amount of smoking has been found to cause popcorn lung."Moreover, there has not been a single reported case of bronchiolitis obliterans linked to vaping in the United States, despite millions of users and a decade worth of experience with heavy use of the product.Claiming that vaping causes popcorn lung is irresponsible, as there is no evidence to back up the claim. If you're going to tell the public that vaping causes a serious and often deadly progressive respiratory disease, you ought to have at least one -- just one -- case to back it up.The truth is that there is no evidence that vaping causes bronchiolitis obliterans and despite having levels of diacetyl that are hundreds of times higher, smoking itself has not been linked to bronchiolitis obliterans.As I've said before, there's plenty of room for differing perspectives on the net public health benefits of electronic cigarettes, but making up false information is not acceptable, nor is it consistent with the ethical principles of public health practice.The comparison to "bioterrorism" is also irresponsible and inappropriate. Vaping companies are doing a tremendous service to millions of smokers throughout the U.S. who have been unable to quit using pharmaceuticals, but have succeeded in quitting thanks to electronic cigarettes. To call these companies bioterrorists is despicable.It is also inappropriate to call Juul a massive public health disaster. True, Juul is a major problem because it is leading to widespread youth use with a significant potential for addiction. But Juul is also helping millions of adults quit smoking. Its market share is up to close to 60%, so it appears to be the most commonly used strategy for quitting smoking in the United States. That's hardly a public health disaster.Finally, it is irresponsible and inappropriate to accuse Juul of "willfully designing and pushing a product that will cause harm to the children of the United States." First of all, Juul did not design the product with the intention of causing harm to children. The product was designed to help adult smokers quit smoking. That is a laudable goal, not an evil one. In fact, the Juul represents a major advance in the effort to promote smoking cessation because it is the first electronic cigarette to deliver nicotine in a manner that is similar to real cigarettes and therefore is acceptable to a larger number of smokers who reject traditional e-cigarettes because they fail to deliver a nicotine hit.Second of all, if you're going to sue Juul, you ought to also sue every single alcohol company as well. Their products are also causing harm to the children of the United States. And what about the tobacco companies themselves? Their products are causing far more harm to the children of the United States than all e-cigarettes combined. Why would we even think about suing Juul but not file suit against the cigarette companies as well?Sadly, the scientific evidence doesn't matter any more in tobacco control. Our pre-determined conclusion that vaping is terrible, based on an almost puritanical ideology, is now running the show. Worse still, the actual truth about the harm being caused by products like Juul is not enough. We have to make up false and alarming information to support our pre-determined conclusions.Let's be clear. There are at least 2 million ex-smokers in the U.S. who have quit smoking because of electronic cigarettes. To call this a public health disaster is to throw these 2 million former smokers under the bus and to essentially conclude that their lives don't matter.I, too, have been outspoken about the risks posed by the widespread adoption of Juuling. But you have to have a sense of perspective. Yes, this is a serious concern. Yes, action needs to be taken to try to stem the tide of Juuling. But the Juul isn't causing substantial health damage. There is no evidence that even long-term Juuling increases the risk for disease. And Juul is helping hundreds of thousands of smokers to quit and perhaps save their lives.The rest of the story is that this Harvard professor has now misled the entire nation into thinking that vaping causes a serious, often fatal, progressive respiratory disease, without a shred of evidence that this is the case and with overwhelming evidence that it simply is not true. Whatever you think about vaping and Juuling, lying to the public is not what we do in public health.Original author: Michael Siegel
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Pediatrics Journal Ignores Its Stated Editorial Standards


The journal Pediatricsin March published an article by University of California San Francisco’s Benjamin Chaffee, Shannon Lea Watkins and Stanton Glantz claiming that e-cigarettes lead to smoking. The claim was baseless; the authors ignored subjects’ past smoking activity, as I explained in an earlier blog post (here). On March 15, I submitted a comment to the journal with a re-analysis of Chaffee’s data using the omitted variable and demonstrating the invalidity of Chaffee’s claim.  On the basis of this flaw, I requested retraction of the article.  Our comment was published on the Pediatrics website March 30, along with a response from Chaffee et al. that further validated a retraction (here).  Their response included an attack on my independence, veracity and transparency.  Clive Bates, David Sweanor, David Abrams and Raymond Niaura endorsed our analysis in an April 11 comment, labeling Chaffee’s response “inadequate, disappointing and surprising.”  They pointed out that it was “disappointing because the authors, apparently with the approval of the journal, have resorted to an ad hominem attack on Rodu and without showing any improper conduct or incomplete disclosure.”  I had responded to the attack by Chaffee et al. with an email to the Pediatrics editors on April 9: “Chaffee et al. stated that my ‘financial ties to the tobacco industry are much more extensive than the posted disclosures suggest.’ This is false, defamatory and potentially libelous on two accounts, alleging that I made an inadequate disclosure, and that I have more ‘financial ties.’ My disclosure was accurate and complete. In addition, the website they cited contains no supporting evidence for their allegation, because I have no other financial ties or conflicts of interest. The journal has specific policies prohibiting both defamatory/libelous comments and weblinks. These policies also provide guidance for your immediate attention to this matter.” (here) On or about April 24, Pediatricspublished a revised response from Chaffee et al.  Their fictitious claims about “financial ties” had disappeared, but the revised text carried the same date as the authors’ original comment.  The editors failed to indicate a correction had been made, and that erroneous and disparaging remarks had been removed.  The editors had allowed the libelous statements to remain on the journal site for nearly a month; the offending remarks are still available elsewhere on the Internet (here). The editors violated the journal’s stated policy: “Once a comment has been posted on the website, you will not have the right to have it removed or edited… Be sure to follow all of the consideration criteria below; you will not be able to modify your comment after submission.” (emphasis in original) Compounding this journalistic failure, the editors encouraged Clive Bates and colleagues to edit their published comment and delete language countering Chaffee et al.’s defamatory remarks.  When Bates did not immediately comply, the editors deleted the entire Bates comment.  However, it is still available here. Journal editors Drs. Lewis First (University of Vermont), Alex Kemper (Nationwide Children’s Hospital, Columbus Ohio) and Mark Neuman (Harvard) owe Pediatrics readers full compliance with their journal’s editorial standards, including a detailed correction notice and republication of the full text of the Bates et al. comment. Original author: Brad Rodu
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Poison Control Centers' Data Puts E-Cigarette Exposure Risk in Perspective


The journal Pediatricsrecently reported that “there were more than 8,200 calls to US poison centers regarding exposures to liquid nicotine and e-cigarettes among children younger than 6 years of age from January 2012 through April 2017, averaging 129 calls each month or more than 4 a day.” (here) As I previously noted (here), annual exposures (which were 1,548 according to the Pediatrics article) should be considered in appropriate perspective.  While the journal article acknowledged that e-cigarette exposures “decreased by about 20% from 2015 to 2016,” its senior author called for additional regulation.  If children’s exposure to products should guide regulatory priorities, the following chart from the American Association of Poison Control Centers (2016 report available here) may be instructive..nobr br { display: none } td { text-align: center} Non-Pharmaceutical Exposures Reported To Poison Control Centers in the U.S., 2016Product CategoryNumber Among Children Under 6 YearsNumber Among All AgesDeaths Per 100,000 Exposures*Cosmetics, personal care products136,004180,0653Household cleaners111,445179,82813Foreign bodies65,86490,6671Pesticides33,45877,57322Plants27,56545,15024Arts, crafts, office supplies20,09627,3190Deodorizers17,39821,26614Essential oils (clove, etc.)13,26418,9970Tobacco11,35813,3190Cigarettes6,3316,699--E-Cigarettes2,0752,827--Chewing tobacco1,2201,357--Other1,7322,436--Foods, additives, spoilage10,83933,9099Alcohols9,56222,289117Chemicals9,32833,91080Gasoline, other hydrocarbons8,82127,80776Bites, venom6,70846,98915Paint, strippers6,60112,2380Batteries5,4839,65141Adhesives, glue4,6929,6220Fumes, vapors3,67331,337214Fertilizers2,7594,59080Other35,85994,02444All540,777980,55026* All AgesOf the half million exposures among children under 6 years of age recorded by poison control centers in 2016, 45.8% involved cosmetics, personal care products or household cleaners, while e-cigarettes accounted for just 0.4%.  Looking at product-related deaths per 100,000 exposures, rates were highest for fumes and vapors (which included carbon monoxide) and for alcohols, but there were no deaths recorded for tobacco exposures, including e-cigarettes.Public health generally and children’s health in particular may benefit from regulatory reform that is keyed to demonstrated risk exposure.Original author: Brad Rodu
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The urge to ban: 10 questions to ask first

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FDA Blocks Consumer Access to New Smokeless Products


When Congress gave the FDA regulatory authority over tobacco in 2009, it specified that manufacturers wanting to sell a new product must get a “substantial equivalence” (SE) order demonstrating to the FDA that the product has the “same characteristics as a predicate tobacco product [i.e. on the market before February 15, 2007]; or has different characteristics than the predicate tobacco product but…does not raise different questions of public health.” (here) Copenhagen brand moist snuff has been available in the U.S. since 1822.  The U.S. Tobacco Company (UST) had 17 different styles of the brand, including 5 pouches and 4 with wintergreen flavoring on the market in 2007. It's worth examining UST's SE application submitted on November 13, 2015 for a variant to be called Copenhagen Bold Wintergreen Pouches.  According to the Troutman Sanders law firm blog (here): “The Copenhagen Bold [WG Pouches] SE submission compared the new product, a portioned smokeless tobacco in pouches with a grandfathered product in the same format (pouched smokeless tobacco) but containing different tobacco.  UST had considered using a different grandfathered product – a loose tobacco product with the exact same blend and formula as Copenhagen Bold – but the FDA discouraged UST from doing so because the grandfathered product was in a different format.  At the FDA’s suggestion, UST designated the grandfathered loose tobacco product with the exact same tobacco blend and formula as Copenhagen Bold as a ‘surrogate’ product.” Despite the company’s acquiescence in using its loose wintergreen snuff as the predicate product, the FDA denied the SE on July 13, 2017.  UST’s appeal of that decision was denied by the agency on January 2, 2018. The company sued the FDA on February 2, seeking to overturn the agency’s action. The filing is available here. This lengthy, so far futile attempt to gain marketing approval for a simple variation of a moist snuff product that is associated with nearly zero health risks underscores the broken state of the FDA review process. To be clear, my criticism of FDA is not intended to further the interests of any company, but rather to advance the health interests of American smokers who should be encouraged to switch to safer smoke-free cigarette substitutes. Limiting the market entry of potentially attractive cigarette alternatives reduces the chance that smokers will give up their dangerous habit. Original author: Brad Rodu
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FDA Is Targeting E-Cigarette Retailers, But They’re Not Teens’ Primary E-Cigarette Source


FDA Commissioner Scott Gottlieb reportedlytestified at a House Appropriations subcommittee April 17 about “excessive use of e-cigarettes among youths…Gottlieb said the FDA will crack down on youths' use of e-cigarettes in the coming weeks.  ‘We are going to take some vigorous enforcement steps to try to perceive what we see is inappropriate use by youth,’ Gottlieb said, refusing to elaborate on when the action will happen.  The agency has several avenues for targeting retailers that are selling to minors.  Those include a warning letter, massive fines, or banning the retailer from selling any tobacco or e-cigarettes.”A common theme among e-cigarette prohibitionists is that the protection of children justifies all forms of regulation.  Beyond that, the commissioner’s remarks are undercut by the fact that only a small percentage of children have tried e-cigarettes, and only a tiny fraction of those youths bought c-cigarettes from retailers.  Support for this is seen in the FDA’s Population Assessment of Tobacco and Health (PATH) survey.  The PATH youth survey collected detailed information about tobacco use from 13,628 participants age 12-17 years in 2013-2014.  Based on the survey’s sophisticated weighting formula, the figures below are estimates for 25 million teens across the U.S.The data reveal that about 2.6 million teens had ever used an e-cigarette in 2013-14.  Of these, about 771,000 had used e-cigarettes in the past 30 days – the widely accepted definition of “current” use among youth and consistent with another federal survey of teen tobacco use (discussed here).  This means that there were far fewer current e-cig users in PATH than currently used alcohol (1.83 million) or marijuana (1.24 million), which is also consistent with other federal surveys (discussed here).Current e-cig users were asked: “In the past 30 days, how did you usually get your own e-cigarettes/cartridges and e-liquid?”  Here are the results:.nobr br { display: none } td { text-align: center} PATH Survey: How Did You Get Your E-Cigarettes?HowNumber of teensPercentageSomeone offered me one353,70046%Gave someone else money to buy them126,50016%Bought them myself75,7009.9%Asked someone to give me one73,7009.7%Got them some other way52,5006.9%Took them from a store or another person31,6004.1%Bought them from another person24,7003.2%Don’t know, refused to answer32,4004.2%All770,800100%The table shows that only 10% of current teen users, about 76,000, bought e-cigarettes for themselves.  In other words, while the FDA and other government agencies pursue vaping manufacturers and retailers, the vast majority of teens get e-cigarettes from unregulated sources.  Of course, even more teens use alcohol, which is only sold to adults age 21+ years, and marijuana, the sale of which is legal to adults only in limited states.Original author: Brad Rodu
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NIH Director Grilled at Appropriations Hearing About NIAAA Collusion with Alcohol Industry

At the House Appropriations Committee hearing on the NIH Budget, NIH director Dr. Francis Collins was grilled about the collusion between the NIAAA and the alcohol industry in planning a clinical trial to study the health benefits of alcohol use. Congresswomen Lucille Roybal-Allard (D-CA) expressed concern about the fact that NIAAA violated NIH policy by soliciting funding from the alcohol companies and asked Dr. Collins who authorized the solicitation of funding. While Dr. Collins did not answer the question, he did say that his office is conducting an investigation and will provide the Inspector General with any uncovered materials that are of concern.The questioning begins at 51:30 of the video.Original author: Michael Siegel
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Another UC San Francisco E-Cigarette Gateway Claim, Based on Tiny Numbers


Last week I called for retraction of a flawed study by University of California San Francisco’s Benjamin W. Chaffee, Shannon Lea Watkins and Stanton A. Glantz that appeared in the journal Pediatrics (hereand here).  Once again using the FDA Population Assessment of Tobacco and Health (PATH) survey, the same authors exaggerated the gateway effect of e-cigarettes, hookah and smokeless tobacco in a January JAMA Pediatrics article (here).  I criticized at that time the omission of information that would have provided context for their findings (here).  The exaggerations were amplified in the media.In an interview with National Public Radio (here), Dr. Watkins failed to note the minuscule numbers used in her study to support the gateway claim.  I have inserted those numbers in bold in her quote, here:“We found that kids who tried e-cigarettes [n=11] or hookah [n=8] or smokeless tobacco [n=3]or cigars [n=7] – any noncigarette tobacco product – were all twice as likely to try cigarettes a year later compared to kids who hadn’t used any of those other tobacco products [n=175].  Kids who were using two or more noncigarette products [n=15] were four times as likely to report using cigarettes a year later.” (I have confirmed these numbers in the FDA data; they are in the table below)Dr. Watkins added the extraordinary claim that trying one tobacco product changes one’s perception of cigarettes: “Using these products might change a kid’s perception of the harm of cigarettes, and so they are perceived as less dangerous and they get used to using tobacco and so using conventional cigarettes is not so scary or ‘bad’.”In her view, trying a tobacco product causes one to change friends: “It will expose them to different kinds of kids, maybe kids that are already using conventional cigarettes, and then they might go on to try them.”Instead of sharing her conjecture on how e-cigarettes led 11 children to begin smoking, Dr. Watkins should have focused on the fact that 80% of the 219 new smokers [n=175] in her study had not previously used any tobacco product..nobr br { display: none } td { text-align: center} Odds Ratios And Numbers of Teens Smoking Cigarettes After One Year, According to Ever Tobacco Status at BaselineEver Tobacco Status- Baseline (n)Odds RatioNumber Smoking At One Year (%)Never tobacco use (9,058)Referent175 (79.9)E-cigarettes (255)2.1211 (5.0)Hookah (189)2.158 (3.7)Other combustible (114)3.087 (3.2)Smokeless tobacco (93)1.533 (1.4)Two or more products (200)3.8115 (6.8)All (9,909)219 (100)Original author: Brad Rodu
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The US media is losing its mind over vaping and Juul – the questions a credible journalist should ask


April 9th, 2018

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Principal Investigator of Alcohol Clinical Trial is Hiding its Industry Funding from the Public and Potential Research Subjects

I have already explained why I think the Moderate Alcohol and Cardiovascular Health (MACH15) clinical trial should be immediately halted because of both scientific and ethical breaches in the way the research was planned. Today, I reveal what I believe is misconduct in the actual conduct of the trial: namely, in the communication of the research sponsors to the public. I believe that the public -- and especially research subjects -- have the right to know who is funding a clinical trial that is seeking their participation. In fact, there are rules requiring the sponsors of such studies to be revealed to the public. However, I believe the MACH15 study is violating these principles by hiding its true sponsors from the public.The Rest of the Story On the study web site, the study sponsor is reported as being the "National Institute on Alcohol Abuse and Alcoholism (NIAAA)." However, nowhere on the site does it disclose that the real sponsor behind the research are alcohol companies, which have ponied up to cover two-thirds of the cost of the entire research project. The alcohol money is being funneled through a "middle man" (the NIH Foundation) on its way to NIAAA, but the source of the money is clear: this is an alcohol industry-funded study. In violation of ethical principles for the conduct of research, this critical information is not being disclosed to the public on the project web site.Therefore, I am calling both the Department of Health and Human Services (through the Inspector General) and Congressional oversight committees to require the study researchers to disclose to the public and potential participants that this study is being funded by the alcohol industry.This is too reminiscent of the unethical behavior of tobacco-funded researchers in the past who failed to disclose the industry funding of their research. In fact, it was this behavior that contributed heavily to the implementation of conflict of interest disclosure rules.The rest of the story is that the principal investigator of the MACH15 trial is hiding from the public the fact that this is an industry-funded study. I believe the trial should be halted, but if it is allowed to continue, the researchers should be forced to disclose the industry funding to the public and to any potential research participants.Original author: Michael Siegel
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Ten perverse intellectual contortions: a guide to the sophistry of anti-vaping activists







This puts it nicely:

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