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Published: Thu, 08 Dec 2016 00:00:00 -0500

Last Build Date: Thu, 08 Dec 2016 01:15:54 -0500


Brickbat: Getting Drilled

Tue, 06 Dec 2016 04:00:00 -0500

(image) The good news is that the Tomah, Wisconsin, Veterans Affairs Medical Center is offering free screenings for hepatitis and HIV to 592 veterans. The bad news is that they are doing this because a VA dentist did not properly clean equipment between patients.

FDA Salt Guidance Could Kill More People Than It Saves

Fri, 02 Dec 2016 11:10:00 -0500

The Food and Drug Administration issued proposed guidance in June to the food industry aiming to reduce the amount of sodium in many prepared foods. In its draft guidance, the agency stated: Average sodium intake in the U.S. is approximately 3,400 mg/day. The draft short-term (two-year) and long-term (10-year) voluntary targets for industry are intended to help the American public gradually reduce sodium intake to 2,300 milligrams (mg) per day, a level recommended by leading experts and the overwhelming body of scientific evidence. The targets are also intended to complement many existing efforts by food manufacturers, restaurants, and food service operations to reduce sodium in foods. The FDA further asserted: CDC has compiled a number of key studies, which continue to support the benefits of sodium reduction in lowering blood pressure. In some of these studies, researchers have estimated lowering U.S. sodium intake by about 40 percent over the next decade could save 500,000 lives and nearly $100 billion in healthcare costs. So, the science of salt is settled, right? Actually, no. The FDA asked for public comments on its draft guidelines and it evidently received sufficient pushback that it extended the deadline for comments until December 2, 2016. As I reported earlier more and more studies are calling into question that idea that reducing salt consumption at the population level will actually result in net health benefits. For example, the New England Journal of Medicine published a study in August 2014 finding that people who consume less 1,500 milligrams of sodium (about 3/4ths of a teaspoon of salt) are more likely to die than people who eat between 3,000 to 6,000 milligrams of sodium per day (1.5 and 3 teaspoons of salt). The free-market think tank, the Competitive Enterprise Institute has submitted comments that show that the FDA's confident claim that reducing salt consumption by Americans will save lives is at best, a hope, and at worst, tragically wrong. The CEI comments to the FDA nicely summarizes the relevant scientific studies. Here is the nub of the issue: Reduced sodium consumption affects different individuals in different ways. Only an estimated 17 to 25 percent of the population is "salt sensitive"—they experience higher blood pressure with increased dietary sodium—while 75 percent are considered salt resistant and will experience no change in blood pressure with altered dietary sodium. However, an estimated 11 to 16 percent of the population are inverse salt sensitive, which means reduced dietary sodium can increase their blood pressure. With this heterogeneity in response to salt, trying to force a population-wide reduction in sodium availability in order to reduce incidences of hypertension would be ineffective at best and counterproductive at worst. Among other evidence, CEI cites a 2014 metanalysis in the American Journal of Hypertension of more than two dozen sodium studies which concluded that risk of death appeared to be lowest among individuals consuming between 2,565mg and 4,796 mg of sodium a day with higher rates of death in the upper and lower range. The FDA itself notes that average daily consumption - 3,400 mg - is right in the middle of that range. CEI correctly argues: For a minority of the population, reducing dietary sodium can be an effective means of lowering cardiovascular and hypertension risk. But identifying for whom sodium restriction may be beneficial and by how much is something that individuals and their doctors must determine. For the general population, sodium reduction is, by no means, a silver bullet to reducing hypertension and has the potential to increase risks for a large portion of the population. Treat people as individuals not just as members of an undifferentiated public health herd. Let's hope that the FDA will heed this advice and withdraw its misguided draft guidance.[...]

Surgeon General's Report Mistakenly Treats All Drug Use As a Problem

Fri, 18 Nov 2016 08:35:00 -0500

You might think Surgeon General Vivek Murthy, who acknowledges marijuana's medical utility, has relatively enlightened views on drug policy. But a report he released yesterday reveals that Murthy is utterly conventional in his attitude toward drinking and other kinds of recreational drug use, which he views as a problem to be minimized by the government. Facing Addiction in America: The Surgeon General's Report on Alcohol, Drugs, and Health claims "addiction is a chronic brain disease" caused by exposure to psychoactive substances, even while acknowledging that the vast majority of people who consume those substances do not become addicted to them. The report describes even low-risk, harmless, and beneficial drug use as "misuse," giving the government broad license to meddle with personal choices through policies aimed at making drugs more expensive and less accessible. Murthy argues that driving down total consumption, rather than focusing on problematic use, is the most effective way to reduce the harm caused by alcohol and other drugs. As he sees it, every drinker and drug user, no matter how careful, controlled, or responsible, is a legitimate target of government intervention. Murthy's report eschews the term substance abuse, explaining that the phrase "is increasingly avoided by professionals because it can be shaming." Instead the report talks about "substance misuse," which "is now the preferred term." But substance misuse is just as judgmental, vague, and arbitrary as substance abuse. In fact, Murthy cannot quite decide what it means. On page 5 of the introduction, he says misuse occurs when people use drugs "in a manner that causes harm to the user or those around them." But elsewhere (including the very next page), the report uses a much broader definition. "Although misuse is not a diagnostic term," Murthy says, "it generally suggests use in a manner that could cause harm to the user or those around them." Could cause harm? That definition is wide enough to cover all drug use. Murthy does seem to think drug use is problematic even when it causes no problems. As an example of drug misuse, Murthy repeatedly cites a 2015 survey in which 25 percent of the respondents, representing 66.7 million Americans, reported that they had engaged in "binge drinking" during the previous month. "By definition," Murthy says, "those episodes have the potential for producing harm to the user and/or to those around them, through increases in motor vehicle crashes, violence, and alcohol poisonings." But the government's definition of a binge—five or more drinks "on an occasion" for a man, four or more for a woman—encompasses patterns of consumption that do not harm anything except the sensibilities of public health officials. If a man at a dinner party drinks a cocktail before the meal, a few glasses of wine during it, and a little bourbon afterward, he is drinking too much, according to Murthy, even if he takes a cab home. By that standard, at least 44 percent of past-month drinkers are misusing alcohol. Murthy also counts all consumption of federally proscribed drugs as misuse, no matter the context or consequences. As far as he is concerned, all 36 million Americans who consumed cannabis last year misused it, even if they lived in states where the drug is legal for medical or recreational purposes (which is now most states). Unauthorized use of prescription drugs also counts as misuse, whether or not harm results. "In 2015," Murthy says, "12.5 million individuals misused a pain reliever in the past year—setting the stage for a potential overdose." That makes the risk sound much bigger than it is. According to the CDC, there were 18,893 deaths involving opioid analgesics in 2014, the most recent year for which data are available. That year, according to the National Survey on Drug Use and Health, 10.3 million Americans used prescription painkillers for nonmedical purposes. On average, they ran a 0.2 percent change of dying as a result. For those who avoided mixing narco[...]

Five More U.S. Jurisdictions Imposed Soda Taxes Last Week

Tue, 15 Nov 2016 11:35:00 -0500

Last week five more jurisdictions joined Berkeley and Philadelphia in imposing special taxes on soda and other soft drinks. Four of the taxes were approved on Election Day by voters in Boulder, Colorado, and three California cities: San Francisco, Oakland, and Albany. The fifth was approved last Thursday by the Cook County, Illinois, Board of Commissioners. Boulder's Ballot Issue 2H, which Eric Boehm noted last week, passed with 54 percent of the vote. It imposes an excise tax of two cents per fluid ounce on drinks that have five or more grams of added sugar in a 12-ounce serving. It does not apply to alcoholic beverages or milk products. San Francisco's Measure V, which passed with 62 percent of the vote, imposes a one-cent-per-ounce excise tax on sugar-sweetened beverages that contain more than 25 calories per 12-ounce serving. Milk products, baby formula, and meal-replacement beverages are exempt. Oakland's Measure HH, which also was favored by 62 percent of voters, imposes the same tax with the same exemptions. Albany's Measure O1, which is essentially the same as the other two California initiatives, passed with 71 percent of the vote. Cook County, which includes Chicago, has 5.2 million residents, making it the most populous U.S. jurisdiction to approve a soda tax so far. Unlike the four 2016 ballot initiatives but like Philadelphia's tax, the one-cent-per-ounce levy approved by Cook County last week applies to artificially sweetened beverages as well as soft drinks with added sugar. That approach broadens the base, raises more money, and makes the tax a bit less regressive (since consumption of sugar-sweetened drinks is especially common in low-income households, while wealthier consumers are more likely to favor diet versions). But it means drinks with zero calories (such as Diet Coke) get hit with a special tax that does not apply to drinks (such as fruit juice) that are just as fattening as regular soda. Taxing beverages without regard to calorie content makes a hash of the already dubious argument that soda taxes will reduce obesity by driving down total calorie intake. If passed through to consumers, the one-cent taxes will add 68 cents to the cost of a two-liter bottle and $1.44 cents to the cost of a 12-pack. Boulder's two-cent tax adds $1.36 and $2.88, respectively. "We understand the health threats posed by unhealthy sugary drinks, especially on low-income families," said Angelique Espinoza, manager of the Boulder soda tax campaign, after the initiative passed. "Today Boulder took an important, proactive step toward ensuring that all of us—our children in particular—have every opportunity to make better choices and to lead healthy lives." The Boulder Weekly had a different perspective: "We oppose 2H with exactly the same line of logic as we use to oppose Amendment 72 [a proposed tobacco tax increase that failed last week]. This is a sin tax that provides money for beneficial programs on the backs of a small segment of the population. We reiterate that sin taxes are regressive, and research shows they do little to curb consumption or improve public health. We hate it when people call Boulder a 'nanny state.' We hate it more when they are right."[...]

Vaping Is a Gateway to Quitting

Wed, 09 Nov 2016 00:01:00 -0500

Survey data indicate that millions of Americans have used electronic cigarettes to quit smoking, thereby dramatically reducing the health risks they face. Thomas Frieden, director of the U.S. Centers for Disease Control and Prevention, is unimpressed. "The plural of anecdote is not data," Frieden recently told The New York Times. But when it comes to the dangers that vaping poses, he abandons his scientific stance, claiming without evidence that "many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes." No doubt Frieden and other e-cigarette alarmists will latch onto a new study that supposedly shows "Flavored E-Cigarettes May Entice Teens to Smoke," as one of the predictable headlines put it. But that is not what the study, reported this week in the journal Pediatrics, actually shows. Looking at data from the 2014 National Youth Tobacco Survey, biostatistician Hongying Dai and economist Jianqiang Hao found that nonsmokers who had used an e-cigarette in the previous month were less likely than other nonsmokers to rule out trying tobacco cigarettes in the future. That is not terribly surprising, since just 3 percent of teenagers who had never smoked reported past-month e-cigarette use, a small minority that is apt to differ from the remaining 97 percent in traits, such as rebelliousness, risk aversion, and sensation seeking, that might affect the propensity to experiment with smoking. Correlation is not causation. The fact that teenagers who vape are less inclined to say they will never smoke does not mean the experience of vaping made them that way. As Dai and Hao note, "we were unable to establish causal inferences" because "the data are cross-sectional." The idea that vaping promotes smoking seems implausible in light of the fact that smoking has fallen to record lows among teenagers even as experimentation with vaping has risen dramatically. Furthermore, teenagers who vape typically use nicotine-free e-liquids, and nonsmokers rarely vape often enough to develop a nicotine habit. According to the Monitoring the Future Study, nearly two-thirds of teenagers who have tried vaping consumed "just flavoring" the last time they did it. In the same survey, less than 1 percent of never-smokers had vaped on 20 or more days in the previous month. Dai and Hao seem to view flavored e-liquids, whether or not they contain nicotine, as a menace to the youth of America. "Flavored e-cigarette use is associated with increased risks of smoking among youth," they conclude. "Comprehensive tobacco control and prevention strategies that address flavored e-cigarette products are critically needed to reduce tobacco use among youth." It is pretty clear what "address[ing] flavored e-cigarette products" means to Dai and Ho, who repeatedly note that the Food and Drug Administration does not plan to ban flavors as part of its otherwise onerous e-cigarette regulations. They worry that "widespread availability of flavored e-cigarettes will increase the use of e-cigarette products by youth" and that "the normalization of e-cigarette use among youth could also lead to e-cigarettes becoming a gateway for future smoking, marking a setback in the decades-long antismoking battle." While there is little reason to think anything like that is happening, banning flavored e-liquids would make vaping less attractive to smokers, thereby discouraging them from making a switch that could save their lives. Contrary to the claims of politicians and activists who insist that candy and fruit flavors could not possibly appeal to anyone older than 17, adults who switch to vaping overwhelmingly prefer supposedly kid-friendly e-liquids. In a 2014 survey by E-Cigarette Forum, three-quarters of adult vapers who had quit smoking or cut back said they favored flavors other than tobacco. A 2013 study likewise found that flavor variety is important for smokers who switch to vaping. Dai and Ho are dismayed that the vaping market feat[...]

Porn-Regulating Prop 60 Faces Final Showdown Tonight in California

Tue, 08 Nov 2016 17:30:00 -0500

Today Californians vote on Proposition 60, a ballot measure sponsored by the AIDS Healthcare Foundation (AHF) that would require condom usage in adult films; empower a full-time state porn czar to monitor said films for violations (and impose steep fines); establish a licensing scheme for porn-production companies; and allow California residents to bring civil suits against porn producers or anyone with financial interests in a sex scene sans prophylactics (which could, in turn, expose porn performers real names and addresses to the public). AHF President Michael Weinstein, the main driver behind Prop 60—and the man who would be the state's first porn czar—has also repeatedly petitioned the California Division of Occupational Safety and Health (Cal/OSHA) to make condoms in porn a requirement of state workplace-safety regulations; Cal/OSHA voted against such a rule again last February. And he's the genesis of a 2012 Los Angeles County law requiring condoms in porn filmed in Los Angeles County. "He wants to be the sheriff of porn town," said Karen Fuller Tynan, a California lawyer who specializes in adult-industry case, at an AVN panel in Las Vegas in January. "He really wants to get rid of us, and wants to rule us." Weinstein, however, maintains that he's interested in stopping the spread of HIV. The porn industry, including the performers Prop 60 is ostensibly meant to protect, has been vocally opposed to the measure, as have HIV/AIDS organizations and the state Democratic, Republican, and Libertarian parties. A partial list of opponents includes adult-industry trade association the Free Speech Coalition, the San Francisco AIDS Foundation, the Los Angeles LGBT Center, the St. James Infirmary, Equality California, all seven of California's largest newspapers (the Los Angeles Times, the San Francisco Chronicle, the San Jose Mercury News, the Orange County Register, the East Bay Times, the Sacramento Bee, and the San Diego Union Tribune) and dozens of other papers. My cali peeps are tellin me #Prop60 & #Prop61 are wolves in sheep clothing (coming in one name but meaning another) and y'all should vote NO — Questlove Gomez (@questlove) November 8, 2016 According to Prop 60 opponents, the measure presents too much of a risk to performer privacy, giving California residents "the ability to out porn performers and get paid for it," as Violet Blue put it at Engadget. ("You're incentivizing the viewer to sue us," adult actor Tommy Gunn told the Hollywood Reporter.) They also worry the law could end up ensnaring individuals who do private webcam shows from their own homes (a rising part of the porn industry) or make amateur adult-films involving real-life a lover, spouse, or friend; California couples with an exhibitionist streak could find themselves facing tens of thousands in fines. But most importantly, it's completely unnecessary—the adult-film industry is self-policing, performers are tested every 14 days, and there hasn't been a single case of on-set HIV transmission in porn since 2004, they say. Vice News Tonight reporter (and Reason alum) Michael Moynihan talked to Yes On 60 campaign manager Rick Taylor on the show's season debut Monday and asked him about his group's claims that the porn industry lies about HIV transmissions. Taylor defended the claim by saying that "none of us know, truthfully, and they don't know and I'm not gonna tell you I know. What I do know is that STDs on a daily basis gets transmitted." Here's a bit more of the exchange: Moynihan: STDs? But if this is the concern, why do the ads you guys run have three people that stated they have contracted HIV on an adult set? They're saying that in the ad. They're saying 'we contracted this on a set,' but you're saying you don't know? Taylor: I'm saying that I believe they did. I'm saying I believe they did. Porn performer Chanel Preston explained to Moynihan later in the segment how condoms[...]

The New York Times Highlights U.S. Officials' Irrational Hostility Toward E-Cigarettes

Wed, 02 Nov 2016 10:30:00 -0400

New York Times science reporter Sabrina Tavernise highlights the tendency of American public health officials to view e-cigarettes as a threat rather than an opportunity, even though vaping offers a much less dangerous alternative to smoking. "A growing number of scientists and policy makers say the relentless portrayal of e-cigarettes as a public health menace, however well intentioned, is a profound disservice to the 40 million American smokers who could benefit from the devices," she writes. Tavernise cites survey data indicating that the percentage of Americans who wrongly view e-cigarettes as no less hazardous than the conventional kind tripled between 2011 and 2015, from about 13 percent to nearly 40 percent. That misperception, encouraged by misleading and sometimes downright false statements from government officials and anti-smoking activists, surely discourages smokers from making a switch that could save their lives. "The unintended consequence is more lives are going to be lost," one critic tells Tavernise, who contrasts the U.S. approach with the attitude of British public health officials, who see e-cigarettes as way to dramatically reduce smoking-related disease and death. David Sweanor, a tobacco control specialist at the University of Ottawa, compares the enormous difference between the health hazards of smoking and the health hazards of vaping to "the relative risks of jumping out a fourth-story window versus taking the stairs." Although the advantage of the the latter option is obvious, he tells Tavernise, American officials "are saying: 'Look, these stairs, people could slip, they could get mugged. We just don't know yet.'" Thomas Frieden, director of the U.S. Centers for Disease Control and Prevention, tells Tavernise he is aware of smokers who say they quit with the help of e-cigarettes, "but the plural of anecdote is not data." Mitch Zeller, who as director of the FDA Center for Tobacco Products is overseeing regulations that are expected to cripple the vaping industry, is similarly dismissive. In a recorded interview that was played at last month's meeting of the Smoke-Free Alternatives Trade Association, Brad Rodu reports, Zeller said he is "absolutely aware of the anecdotal reports about individuals using e-cigarettes to help them quit, but we can't make population-level policy on the basis of anecdotal reports," because "FDA is required to use a population health standard." Rodu, a professor of medicine at the University of Louisville and a longtime tobacco harm reduction advocate, notes that we do have "population-level" data from surveys of current and former smokers. In the 2015 National Health Interview Survey, for instance, "2.5 million former smokers were current users of vapor products," which suggests e-cigarettes are a pretty popular and effective way to quit smoking. "These 2.5 million former smokers are more than anecdotes," Rodu writes. "They constitute population-level evidence." Likewise the survey data indicating that more than 6 million Europeans have quit smoking with the help of e-cigarettes, while more than 9 million have cut back. Tavernise notes that "surveys by Action on Smoking and Health, a British antismoking group, have found that half of Britain's 2.8 million e-cigarette users no longer smoke real cigarettes." She adds that another British study, published by the journal Addiction in 2014, found that "among people who are trying to quit smoking, e-cigarette users are 60 percent more likely to succeed than those who use over-the-counter nicotine therapies like gum and patches." Such observational evidence does not conclusively prove that e-cigarettes help smokers quit. Maybe the vapers who used to smoke would have quit anyway, and maybe the advantage over nicotine gum and patches has to do with the sort of people who choose e-cigarettes, as opposed to the e-cigarettes themselves. But controlled, randomized e[...]

Tennessee Department of Health Admits It Was Wrong About Reported Huge Rise in Accidental Gun Deaths

Tue, 27 Sep 2016 21:20:00 -0400

Accidental gun deaths in Tennessee, it was reported in various places a couple of weeks back, had zoomed horrifically from 19 in 2013 to 105 in 2014.

A representative report from TV station WTOC:

Tennessee leads the country in accidental shooting deaths.

The Volunteer State ranked ninth in 2013 for deadly accidental shootings. Officials say 19 people died that year.

In 2014, the number jumped to 105.

"This idea of shooting first and asking questions later unfortunately sometimes has fatal consequences," said Beth Joslin Roth with Safe Tennessee Project, a grassroots organization dedicated to addressing the epidemic of gun-related injuries and gun violence in Tennessee.

The numbers have fluctuated some over the years, but Joslin Roth said the jump between 2013 and 2014 is unprecedented.


Unprecedented indeed, and totally not true as it turns out.

Tennessee now admits they made a mistake in counting, and a very big one. 2014's accidental gun death numbers were in fact the lowest, by far, the state has seen this century, at 5. The next lowest was 2008's 17.

From the Tennessee Department of Health, posted last Thursday:

After manually reviewing death certificates, TDH reports five people died from accidental gunshot wounds in the state in 2014. In an additional eight cases, the manner of death was left blank or marked as pending on the death certificate but no follow-up death certificate was sent to the department; however, a review of the autopsies for those cases indicated none of those eight were accidental deaths. Incorrect data provided earlier indicated the number of accidental gunshot deaths had dramatically escalated from 19 in 2013 to 105 in 2014.

"We regret any confusion that may have arisen when data errors affected the number of deaths attributed to the accidental discharge of firearms in our state," said TDH Deputy Commissioner for Population Health Michael Warren, MD, MPH.

Three of the four stories I linked to above with the original frightening report, including the one quoted from, have not yet been corrected as of time of this posting.

As I've written before when it comes to crummy gun data or analysis, generally once a lot of people have read the original headline making a frightening claim regarding guns, the "public policy" work important to those who want to gin up anxiety about guns or optimism about gun laws has already been done, no matter later revelations, adjustments, critiques, or re-evaluations.

Hat tip: Matt Schonert

National Study Debunks Helena Smoking Ban Miracle (Again)

Mon, 26 Sep 2016 08:00:00 -0400

If the people who promote the idea that smoking bans immediately slash heart attacks were interested in the truth, as opposed to another argument for a policy they already support, a study published this month in the journal Medical Care Research and Review would make them retract that outlandish, biologically implausible claim. Looking at county-level data from 28 states, the study finds "smoking bans were not associated with acute myocardial infarction or heart failure hospitalizations." That will come as a surprise to anyone who accepted the propaganda peddled by anti-smoking activists at face value. Since 2003, when supporters of a smoking ban in Helena, Montana, announced that the ordinance had miraculously cut heart attacks in half during the first six months it was in effect, such claims have become conventional wisdom within the tobacco control movement. They were even endorsed by the Institute of Medicine, a division of the National Academy of Sciences, in an embarrassing 2009 report that disregarded obvious methodological problems and replaced science with wishful thinking. As Rice University health economist Vivian Ho and the other authors of the new study point out, "Each of the studies the Institute of Medicine reviewed had at least one important limitation, such as a small study population, lack of a contemporaneous control population, or failure to account for the full range of factors that could influence hospitalizations for smoking-related conditions, such as increased cigarette taxes and local patient and health care market characteristics." Ho et al., by contrast, studied 390 counties that adopted "comprehensive public place smoking bans" from 2001 through 2008, along with 1,511 counties that did not. They controlled for potential confounding variables such as cigarette tax rates and local demographics, and they took into account pre-existing local trends. Heart disease death rates have been declining for decades in the United States, so a drop in the hospitalization rate for acute myocardial infarction (AMI) after the implementation of a smoking ban could be due to that nationwide trend rather than any local development. Furthermore, thousands of jurisdictions around the world have adopted smoking bans, and some of them were bound to see above-average reductions in AMI admissions afterward purely by chance. Focusing just on those places, as anti-smoking activists tend to do, creates a misleading impression. And even if it turned out that jurisdictions with smoking bans tended to see bigger reductions in AMI hospitalization rates than other jurisdictions, that difference could be caused by factors other than the ordinances. Ho et al. found, for example, that jurisdictions adopting bans during the study period tended to tax cigarettes more heavily in 2001 and impose larger tax hikes by 2008. "In adjusted analyses that accounted for cigarette tax rates and population and health care market characteristics," the researchers report, "comprehensive public place smoking bans were not associated with lower AMI or heart failure hospitalization rates." As they note, that result is consistent with the findings of another national study, published by the Journal of Policy Analysis and Management in 2010, in which Kanaka Shetty and his colleagues at the RAND Corporation found "smoking bans are not associated with statistically significant short-term declines in mortality or hospital admissions for myocardial infarction or other diseases." Although those data were available in a working paper when the Institute of Medicine studied the issue, they were conveniently omitted from its report. Ho et al. say their study, while reaching essentialy the same conclusion as Shetty et al., is stronger because it used comprehensive hospitalization data rather than the 20 percent sample on which the earlier analy[...]

More Evidence That Vaping Is Not a Gateway to Smoking

Mon, 19 Sep 2016 00:01:00 -0400

Three years ago, Thomas Frieden, director of the U.S. Centers for Disease Control and Prevention (CDC),warned that "many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes." That fear is one of the main justifications for the CDC's hostility toward vaping and the Food and Drug Administration's onerous new e-cigarette regulations, which are expected to cripple the industry. Yet there is no evidence that Frieden's claim is true and considerable evidence that it's not, especially since smoking rates among teenagers have fallen to record lows even as more and more of them experiment with vaping. Two new studies cast further doubt on the idea that e-cigarettes are a "gateway" to the real thing. Frieden and other e-cigarette alarmists make much of the fact that the percentage of teenagers who report vaping has risen dramatically in recent years. They like to focus on the percentage of teenagers who have ever tried e-cigarettes and the percentage who have used them in the last month, without asking how many are experimenters or occasional users and how many are daily vapers—the sort who might get hooked on nicotine and eventually progress to conventional cigarettes. It turns out there's a good reason for the CDC's lack of curiosity on this point: Survey data show that few teenagers who have never smoked use e-cigarettes and that even fewer do so on a regular basis. "Many fear that e-cigarette use by non-smoking students will lead many to nicotine addiction and subsequent cigarette smoking," notes University of Michigan health economist Kenneth Warner in an American Journal of Preventive Medicine article published last month. But based on data from the Monitoring the Future Study (MTF), which surveys students in the eighth, 10th, and 12th grades, Warner finds that "non-smoking high school students are highly unlikely to use e-cigarettes" and even less likely to use them regularly. Among the 12th-graders who had never tried conventional cigarettes, 94 percent had not used an e-cigarette in the previous month. Among the never-smokers who reported using e-cigarettes in the previous month, 60 percent used them on only one or two days. Less than 1 percent of never-smokers had vaped on 20 or more days in the previous month. The MTF numbers, which are similar to the findings of British surveys, suggest it is quite unlikely that "many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes," because nonsmokers rarely use e-cigarettes often enough to develop a nicotine habit. Another point Warner emphasizes makes Frieden's claim even less plausible: "A large proportion of students use e-cigarettes containing no nicotine." Warner cites a 2014 study that found most never-smoking Connecticut teenagers who vaped used nicotine-free e-liquid. The significance of that point is underlined by another recently published analysis of MTF data. Richard Miech and three of his colleagues at the University of Michigan's Institute for Social Research (which conducts the survey) report in the journal Tobacco Control that nearly two-thirds of teenagers who have tried vaping consumed "just flavoring" the last time they did it. "Nicotine use came in a distant second," Miech et al. write, "at about 20 percent in 12th and 10th grade and 13 percent in 8th grade." The other options were marijuana and "don't know." The MTF data indicate that the more frequently teenagers vape, the more likely they are to vape nicotine. Among high school seniors, 47% of those who had vaped six or more times in the previous month reported consuming nicotine, compared to 23 percent of those who had vaped one to five times in the previous month. But "in no case did the prevalence of nicotine vaping reach 50% or greater." In other words, "the majority of US youth who [...]

Two New Studies Discredit the CDC's Dire Warnings About E-Cigarettes and Teenagers

Fri, 16 Sep 2016 06:30:00 -0400

(image) For several years now, the CDC has been freaking out about adolescent e-cigarette use, which it warns will boost smoking by getting teenagers hooked on nicotine in a more palatable form. But as I explain in my latest Forbes column, that does not seem to be happening, and new research suggests it probably never will:

Three years ago, Thomas Frieden, director of the U.S. Centers for Disease Control and Prevention (CDC),warned that "many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes." That fear is one of the main justifications for the CDC's hostility toward vaping and the Food and Drug Administration's onerous new e-cigarette regulations, which are expected to cripple the industry. Yet there is no evidence that Frieden's claim is true and considerable evidence that it's not, especially since smoking rates among teenagers have fallen to record lows even as more and more of them experiment with vaping. Two new studies cast further doubt on the idea that e-cigarettes are a "gateway" to the real thing.

Read the whole thing.

Most Adolescent Vapers Are Not Nicotine Users

Fri, 02 Sep 2016 10:20:00 -0400

The Food and Drug Administration (FDA), having decided to regulate tobacco-free e-cigarettes as tobacco products because they deliver tobacco-derived nicotine, now has the challenge of explaining how even nicotine-free e-liquids can qualify for the same label. E-cigarette alarmists at the U.S. Centers for Disease Control and Prevention (CDC) have a similar problem. They insist on counting vaping as "tobacco use," which leads them to claim there has been "no decline in overall youth tobacco use since 2011," even though that is clearly not true. Now a new study in the journal Tobacco Control reveals the CDC's position to be even more ridiculous than it already seemed, showing that a large majority of teenagers who vape are not only not consuming tobacco; they are not consuming nicotine either. Based on data from the 2015 Monitoring the Future Study, which surveys students in the eighth, 10th, and 12th grades, Richard Miech and three of his colleagues at the University of Michigan's Institute for Social Research (which conducts the survey) report that nearly two-thirds of teenagers who have tried vaping consumed "just flavoring" the last time they did it. "Nicotine use came in a distant second," Miech et al. write, "at about 20% in 12th and 10th grade and 13% in 8th grade." The other options were marijuana and "don't know." The survey data indicate that the more frequently teenagers vape, the more likely they are to vape nicotine. Among high school seniors, 47 percent of those who had vaped six or more times in the previous month reported consuming nicotine, compared to 23 percent of those who had vaped one to five times in the previous month. But "in no case did the prevalence of nicotine vaping reach 50% or greater." The fact that most adolescent vapers do not vape nicotine was mentioned in a summary of the 2015 survey results published last year, as Pennsylvania anti-smoking activist (and harm reduction advocate) Bill Godshall pointed out at the time. I noted that finding in a blog post last April and a column last June. But the Tobacco Control article presents more-detailed data on this question and highlights the CDC's mendacity. It was already absurd to claim teenagers were using tobacco when they weren't, especially since the CDC used that inaccurate terminology to imply that the rising popularity of vaping somehow cancels out the health gains from the continuing decline in smoking, a far more dangerous habit. Now that it's clear the typical adolescent vaper is not even using nicotine, the CDC cannot assume any chemical connection between e-cigarettes and tobacco. Furthermore, its warnings that teenagers might start smoking after they get hooked on nicotine by vaping look even more overblown than they did before. As Meich et al. note, even the practice of referring to vaporizers as "electronic nicotine delivery systems" (as both the CDC and the FDA do) is quite misleading, at least in the context of adolescent use. "The majority of US youth who use vaporisers and e-cigarettes do not vape nicotine," the authors write. "This finding challenges many common assumptions and practices." The numbers "suggest that the recent rise in adolescent vaporiser use does not necessarily indicate a nicotine epidemic," and they show how misleading the CDC's equation of vaping with tobacco use is. Meich et al. note that counting every vaper as a tobacco user doubles the supposed prevalence of tobacco use among 12th-graders and nearly triples it among 10th- and eighth-graders. If vapers are counted as tobacco users only when they vape nicotine (still a dubious maneuver), the effect is much less dramatic. "If vaporiser users are considered nicotine users only if they last vaped nicotine in the last 30 days," the researchers say, "then national[...]

Experiment Confirms Lifesaving Potential of E-Cigarettes

Mon, 22 Aug 2016 08:53:00 -0400

A new experimental study—the first of its kind, according to the authors—confirms that smokers can dramatically reduce their exposure to toxins and carcinogens by switching to e-cigarettes. "They are safer," the lead author, Maciej Goniewicz, a toxicologist at the Roswell Park Cancer Institute, told Buffalo Business First. "It's the first time we have very strong evidence that we will be able now to give [smokers] that the answer is, yes, this you should consider a transition, a substitute for your tobacco cigarette that will save your life." The study, reported last week in the journal Nicotine & Tobacco Research, involved 20 Polish smokers who were encouraged to replace their cigarettes with the M201, a pen-style vaping system popular in Poland. Each week during the two-week experiment, the researchers supplied the subjects with 20 tobacco-flavored cartridges, each containing 11 milligrams of nicotine in a solution of propylene glycol and vegetable glycerin. Goniewicz and his colleagues used questionnaires and urine tests to assess the subjects at the beginning of the study, after a week, and after two weeks. Nine of the subjects stopped smoking completely, while the rest cut back, from an average of 16 cigarettes a day at the beginning of the study to an average of just one a day at the end. Based on tests for seven nicotine metabolites, the researchers found that nicotine intake stayed the same, while exposure to tobacco-related toxins and carcinogens fell. Goniewicz et al. measured biomarkers for 13 toxins and carcinogens; all but a few declined substantially after the smokers started using e-cigarettes. For example, exposure to NNK, a tobacco-specific nitrosamine "directly associated with lung cancer risk," had fallen by 64 percent after the second week. Exposure to the volatile organic compounds acrolein, ethylene oxide, benzene, and 1,3-butadiene fell by 56 percent, 61 percent, 76 percent, and 84 percent, respectively. "The observed decline in various urine toxicant biomarker levels in our study was similar to decline among smokers who have quit smoking completely and did not substitute with any other product," Goniewicz et al. write. "This observation suggests that e-cigarettes are not a significant source of exposure to those toxicants." Based on chemical analyses of e-cigarette vapor, other researchers have estimated that switching from smoking to vaping reduces health risks by at least 95 percent. Goniewicz et al. also found declines in reports of chest tightness, visual disturbances, daytime coughing, difficulty concentrating, irritability, and phlegm, although only the first two changes were statistically significant. A larger sample with a longer follow-up period probably would supply further evidence of health improvement. The authors note that a 2014 survey of 19,000 e-cigarette users "suggest[s] use of these products pose minimal side effects to users and can in fact improve reported health issues experienced when using tobacco cigarettes," including respiratory symptoms caused by asthma and chronic obstructive lung disease. "This study showed for the first time that after switching from tobacco to e-cigarettes, nicotine exposure remains unchanged, while exposure to selected carcinogens and toxicants is substantially reduced," Goniewicz et al. conclude. "These findings suggest that e-cigarettes may effectively reduce exposure to toxic and carcinogenic substances among smokers who switched to these products."[...]

FDA Says Nicotine-Free E-Liquids Are Tobacco Products in 'Certain Circumstances'

Fri, 19 Aug 2016 09:16:00 -0400

This week, responding to one of the lawsuits challenging its e-cigarette regulations, the Food and Drug Administration (FDA) further muddied the question of whether those regulations apply to products that do not contain tobacco-derived nicotine. The lawsuit, which was brought by Nicopure, a manufacturer of e-liquids and vaping systems, argues that such a result would be unfair, illogical, and illegal. In response, the FDA says Nicopure has failed to show that any of its nicotine-free liquids are actually covered by the regulations and therefore has no standing to challenge that aspect of the rules. At the same time, the FDA concedes that "e-liquids marketed as 'nicotine-free' may properly be considered tobacco products—or components or parts thereof—under certain circumstances." What circumstances are those? "Some e-liquids 'claiming to be nicotine-free actually contain[] high levels of nicotine," the FDA says, quoting its regulations. "Others are tobacco flavored, and are thus 'made or derived from tobacco' regardless of their nicotine content." Does that mean e-liquids are not subject to the FDA's burdensome, prohibitively expensive regulations as long as they do not contain nicotine or any other tobacco derivative? No, because the FDA's definition of "tobacco product" does not require nicotine or any other tobacco derivative. The Family Smoking Prevention and Tobacco Control Act, the statute that gave the FDA authority over tobacco products, defines them as products "made or derived from tobacco that [are] intended for human consumption, including any component, part, or accessory of a tobacco product." In deeming e-cigarettes to be tobacco products, the FDA defined "component or part" as "any software or assembly of materials intended or reasonably alter or affect the tobacco product's performance, composition, constituents, or characteristics" or "to be used with or for the human consumption of a tobacco product." Hence vaping equipment, whether a closed, disposable e-cigarette or an open system with a refillable tank and parts that can be switched out, is a "component or part" of a tobacco product, which means it is also a tobacco product. Does that mean a nicotine-free e-liquid is a "component or part" of a tobacco product—i.e., the vaporizer? The FDA can't or won't give a straight answer to that question. "The only nicotine-free e-liquids that the rule brings under the FDA's regulatory authority are those that are made or derived from tobacco (such as tobacco-flavored varieties) or that otherwise meet the definition of a 'component' or 'part,'" it says. "Thus, nicotine-free e-liquids not made or derived from tobacco are subject to the deeming rule only where they meet the definition of a 'component or part.'...Whether nicotine-free e-liquids meet this definition 'will be evaluated on a case-by-case basis.'" That means a company like Nicopure cannot know ahead of time which of its products are covered by the regulations. It can only find out by asking the FDA about each one, a process that will carry its own costs, even if they do not rise to the hundreds of thousands or millions of dollars that each "premarket tobacco product application" is expected to cost. The FDA's position is that Nicopure can't challenge the potential regulation of its nicotine-free e-liquids because it does not know whether they will actually be regulated. Never mind that it doesn't know because the FDA won't say.[...]

FDA E-Cigarette Regulations Give Smoking a Boost

Mon, 15 Aug 2016 00:01:00 -0400

The Food and Drug Administration's e-cigarette regulations, which took effect last week, immediately struck two blows against public health. As of Monday, companies that sell vaping equipment and the fluids that fill them are forbidden to share potentially lifesaving information about those products with their customers. They are also forbidden to make their products safer, more convenient, or more pleasant to use. The FDA's censorship and its ban on innovation will discourage smokers from switching to vaping, even though that switch would dramatically reduce the health risks they face. That effect will be compounded by the FDA's requirement that manufacturers obtain its approval for any vaping products they want to keep on the market for longer than two years. The cost of meeting that requirement will force many companies out of business and force those that remain to shrink their offerings, dramatically reducing competition and variety. All of this is unambiguously bad for consumers and bad for public health. Yet the FDA took none of it into account when it estimated the costs imposed by its regulations, simply assuming that good intentions would ensure good results. Although preventing fraud is the official intent of the FDA's speech restrictions, the agency's rules prohibit statements that are accurate and highly relevant to consumers choosing between smoking and vaping. Nicopure, one of the companies that is challenging the FDA's regulations in federal court, used to tell consumers that in vaping "nothing is burned," "no smoke is released," and "no ash" is generated. It also noted that the aerosol produced by e-cigarettes contains "no tar" and only "a fraction of the 4000 chemicals currently found in standard tobacco cigarettes." Although all of these statements are indisputably true, they are illegal under the FDA's reading of the Family Smoking Prevention and Tobacco Control Act. That law gave the FDA authority over tobacco products, a category to which it has arbitrarily assigned tobacco-free e-cigarettes, even when they contain nicotine that is not derived from tobacco or no nicotine at all. The Tobacco Control Act prohibits unapproved "modified risk" claims, including any "explicit or implicit representation that [a] tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke." According to the FDA, that means e-cigarette companies are not allowed to advertise the main advantage of their products. Even describing an e-cigarette as "smokeless" or "smoke-free" is asking for trouble, since "the Agency will evaluate an [e-cigarette] manufacturer's use of 'smokeless' or 'smoke-free' (and similar descriptive terms) on a case-by-case basis." Instead of immediately banning all e-cigarettes and e-fluids, the FDA gave manufacturers a couple of years to seek approval for each of their products. But that grace period does not apply to any variations introduced after August 8, 2016, so the FDA has in effect banned product improvements. In a declaration supporting Nicopure's lawsuit, CEO Jeff Stamler notes that his company "introduced approximately 288 new e-liquid products, 6 new vaporizer products, and 23 new vaporizer components" in 2015 alone. Now any new product requires premarket approval, so "as a practical matter Nicopure will be unable to introduce new products for several years." The ban applies even to minor changes. The American Vaping Association notes that "any variation of the nicotine level, bottle size, flavor amount, ingredient type, etc. in a current product (i.e., one being marketed on August 8, 2016) will result[...]