News & Analysis Medical News & Perspectives ........p123
Lab, Field, & Clinic ...........................p127
News From the CDC........................p129
Experts Call for Research Plus Regulation of e-Cigarettes
New Compound Inhibits Elusive Protein Behind Many Cancers
Epilepsy Linked With Comorbidities
CDC: Use of Emerging Tobacco Products Increasing Among US Youths
Capitol Health Call ..........................p128
Researchers Describe Novel Interventions to Improve Healthy Lifestyle Choices in Diverse Settings US Views Shift on End-of-Life Care news@JAMA: From JAMA’s Daily News Site
Cyclosporiasis Outbreaks Traced to Salad Mix and Cilantro in Salsa
GAO: Better Coordination Needed to Avoid Duplicate Autism Research GAO: VA Peer Review Process After Adverse Events Not Working Preemies, Pediatric Research, Retired Chimps to Benefit From New Law The Drug Quality and Security Act Becomes Law
Medical News & Perspectives
Experts Call for Research Plus Regulation of e-Cigarettes Tracy Hampton, PhD
B
ecause using a product that can cause addiction to nicotine is generally a bad idea, it stands to reason that people should steer clear of electronic cigarettes, which provide doses of nicotine and other additives in an aerosol form. On the other hand, for current smokers, the battery-powered devices that contain no tar and fewer toxins might offer a less unhealthy alternative to traditional cigarettes. Regulators, public health officials, and clinicians are struggling with these and other complexities associated with e-cigarettes as they work to regulate the products and advise individuals concerning their use. “I started out agnostic on these issues,” said Stanton Glantz, PhD, director of the Center for Tobacco Control Research and Education at the University of California, San Francisco. Based on what he knows now, he says, “the bottom line is that e-cigarettes seem like a good idea but probably aren’t.” Glantz and others are gathering important data on the potential risks and benefits of e-cigarettes to help inform the discussion about these products and to determine whether e-cigarettes deliver promise or peril—or perhaps a bit of both. (See also Viewpoint on e-cigarettes in this issue.)
health at the Centers for Disease Control and Prevention (CDC). But studies consistently reveal that most people who use e-cigarettes are so-called dual users, meaning that they use ecigarettes as well as paper-and-tar cigarettes (Regan AK et al. Tob Control. 2013; 22[1]:19-23; Vickerman KA et al. Nicotine Tob Res. 2013;15[10]:1787-1791; Pearson JL et al. Am J Public Health. 2012;102[9]:17581766). And because smoking-related cardiovascular and cancer risks depend more on how long people smoke than on how much they smoke, dual users are unlikely to gain health benefits from smoking a few less traditional cigarettes each day (Bjartveit K, Tverdal A. Tob Control. 2005;14[5]:315-320). It’s also questionable whether ecigarettes can be a more effective smoking
cessation aid than other nicotine cessation products for smokers who want to quit. The only randomized clinical trial that compared e-cigarettes with conventional nicotine patches found no statistically significant difference in the ability of smokers to quit when they used e-cigarettes or nicotine patches (Bullen C et al. Lancet. 2013; 382[9905]:1629-1637). Even if e-cigarettes could provide benefits to some adult smokers, officials say that the biggest problem with e-cigarettes pertains to adolescents, in whom nicotine use can have harmful effects on brain development. A recent CDC report revealed that the proportion of middle and high school students who have used e-cigarettes doubled to nearly 7%, or almost 2 million, between 2011 and 2012 (CDC. MMWR Morb Mortal
Reed Saxon/AP Images
Less Toxic but Still Dangerous No one questions whether e-cigarettes are less toxic than tobacco-based cigarettes. “It’s a reasonable assumption that if smokers switch completely, it would benefit their health,” said Tim McAfee, MD, MPH, who is the director of the office on smoking and
The use of e-cigarettes has increased sharply in recent years, with revenues doubling every year since 2008.
jama.com
JAMA January 8, 2014 Volume 311, Number 2
Copyright 2014 American Medical Association. All rights reserved.
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News & Analysis
Wkly Rep. 2013;62[35]:729-733). Manufacturers say that e-cigarettes are not marketed to children. But e-cigarettes come in flavors such as butterscotch and marshmallow; are seen as hip, modern, and “tech-y”; and are not subject to age restrictions on sales in many states—all attributes that experts suspect could foster use of these devices as a starter product to nicotine addiction for youngsters. Glantz’s recent research involving adolescent e-cigarette users in Korea points to additional concerns (Lee S et al. J Adolesc Health. doi:10.1016/j.jadohealth.2013.11.003 [published online November 22, 2013]). “This was a cross-sectional study, so we have to be careful about making claims about our findings, but we showed that kids using ecigarettes were much less likely to have stopped smoking and were also heavier smokers,” said Glantz. “So contrary to the harm reduction argument, it seems that ecigarettes might not help with quitting and might actually reinforce smoking instead.”
In Need of Regulation Glantz and others are waiting for the US Food and Drug Administration (FDA) to set federal regulations for e-cigarettes. Between 2008 and 2010, the FDA sought to regulate e-cigarettes as drug (nicotine) delivery devices, but e-cigarette companies sued, and the courts ruled in 2010 that e-cigarettes should be regulated as tobacco products. The following year, the FDA announced that it would work to extend its tobacco-related authority to e-cigarettes as tobacco products under the Family Smoking Prevention and Tobacco Control Act (http://1.usa.gov/18zn0Ls). Last year, a proposed rule, which has not been made public, was submitted to the White House’s Office of Management and Budget and Office of Information and Regulatory Affairs for review. The regulations are urgently needed as e-cigarettes gain popularity, with their revenues doubling every year since 2008. In addition to the many adolescents who use ecigarettes, about 21% of adults who smoke traditional cigarettes also use the electronic versions, according to the CDC (King BA et al. Nicotine Tob Res. 2013;15[9]:16231627). But Glantz suspects that because of the time it will take to develop regulations, solicit public comments, and deal with lawsuits from manufacturers, any meaningful FDA rule will take at least several years to establish and implement. And some issues— 124
like indoor public use, taxation, and licensing—will not be addressed by the agency. While the FDA works out its strategy for regulatinge-cigarettes,stateandlocallawmakers are proposing rules of their own. Several states and more than 100 cities have already included e-cigarettes in indoor smoking bans, and others are considering following suit. “Including e-cigarettes in clean indoor air laws is the single most important policy to implement now,” said Glantz. “Doing so will not only protect people from secondhand ecigarette emissions but will prevent the renormalization of public tobacco use.” Some states have labeled e-cigarettes as tobacco products, while others have passed measures that define them as something else, such as “alternative nicotine products” or “vapor products.”
Addressing the Issue With Patients McAfee said that clinicians need to take action aswell.“Asdataareaccumulatingonissuesrelated to e-cigarettes, we can’t just sit on the sidelines while sales to minors, public use, and marketing campaigns go unregulated.”
He noted that information conveyed by cliniciansaboute-cigarettesshouldtakeondifferentforms,dependingonthoseinvolved.For adolescents, the message is clear: e-cigarette use should be discouraged and discussed alongsidetraditionalmessagingabouttobacco use.“Foradultsit’smorecomplicated,”hesaid. “Wedon’twanttodiscouragepeoplefromtrying to quit, but we don’t want to encourage them to get settled in dual-use land.” McAfee is also concerned that continued implementation of strategies that have been proven to lower smoking rates might be stalled or slowed while attention is focused on e-cigarettes. “A big danger is that this will serve as a distraction from getting people off cigarettes,” he said. For now, experts say that the need remains not only for rules about e-cigarette use andmarketing,butalsoforresearchtoprovide definitiveanswersaboutpotentialbenefitsfor people trying to quit smoking and about such potentialharmsasfosteringnicotineaddiction intheyoung,encouragingsmokerstocontinue or resume the habit, or subjecting nonsmokers to secondhand e-cigarette emissions.
CDC: Use of Emerging Tobacco Products Increasing Among US Youths Mike Mitka, MSJ
E
merging tobacco products such as electronic cigarettes (e-cigarettes) and hookahs are gaining popularity among US middle and high school students, although these students’ overall tobacco use remains the same, according to a report on current tobacco use by US youths. The report was issued by the Centers for Disease Control and Prevention (CDC) in the November 15 Morbidity and Mortality Weekly Report (ttp://1.usa.gov/1dGvtwu). Comparing data from the 2011 and 2012 National Youth Tobacco Surveys (http://1.usa .gov/JsRJAk), the CDC researchers found e-cigaretteuseincreasedamongmiddleschool students (grades 6 through 8) from 0.6% to 1.1%; among high school students (grades 9 through 12), e-cigarette use increased from 1.5% to 2.8%. Current use is defined as using 1ormoretobaccoproductsinthepast30days. Hookah use among high school students rose from 4.1% in 2011 to 5.4% in 2012. The researchers also found that cigar use among black high school students increased from
11.7%to16.7%,althoughcigaruseamonghigh school students overall remained statistically the same (11.6% in 2011 and 12.6% in 2012). The CDC report notes that increased use of e-cigarettes and hookahs may be the result of an increase in their marketing, availability, and visibility and the perception that they may be safer alternatives to cigarettes. Hookahs, cigars, e-cigarettes, and certain other new types of tobacco products are not currently subject to US Food and Drug Administration regulation. Although overall tobacco use from 2011 to 2012 decreased from 7.5% to 6.7% among middle schoolers and from 24.3% to 23.3% among high schoolers, the declines were not statistically significant. Use of bidis, thin hand-rolled cigarettes from India and other Southeast Asian countries composed of tobacco and sometimes flavorings, and kreteks (also known as clove cigarettes) from Indonesia, decreased significantly among both middle and high school students in 2012 compared with 2011.
JAMA January 8, 2014 Volume 311, Number 2
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a SUNY Binghamton User on 05/12/2015
jama.com
Lab, Field, & Clinic ...........................p127
News From the CDC........................p129
Experts Call for Research Plus Regulation of e-Cigarettes
New Compound Inhibits Elusive Protein Behind Many Cancers
Epilepsy Linked With Comorbidities
CDC: Use of Emerging Tobacco Products Increasing Among US Youths
Capitol Health Call ..........................p128
Researchers Describe Novel Interventions to Improve Healthy Lifestyle Choices in Diverse Settings US Views Shift on End-of-Life Care news@JAMA: From JAMA’s Daily News Site
Cyclosporiasis Outbreaks Traced to Salad Mix and Cilantro in Salsa
GAO: Better Coordination Needed to Avoid Duplicate Autism Research GAO: VA Peer Review Process After Adverse Events Not Working Preemies, Pediatric Research, Retired Chimps to Benefit From New Law The Drug Quality and Security Act Becomes Law
Medical News & Perspectives
Experts Call for Research Plus Regulation of e-Cigarettes Tracy Hampton, PhD
B
ecause using a product that can cause addiction to nicotine is generally a bad idea, it stands to reason that people should steer clear of electronic cigarettes, which provide doses of nicotine and other additives in an aerosol form. On the other hand, for current smokers, the battery-powered devices that contain no tar and fewer toxins might offer a less unhealthy alternative to traditional cigarettes. Regulators, public health officials, and clinicians are struggling with these and other complexities associated with e-cigarettes as they work to regulate the products and advise individuals concerning their use. “I started out agnostic on these issues,” said Stanton Glantz, PhD, director of the Center for Tobacco Control Research and Education at the University of California, San Francisco. Based on what he knows now, he says, “the bottom line is that e-cigarettes seem like a good idea but probably aren’t.” Glantz and others are gathering important data on the potential risks and benefits of e-cigarettes to help inform the discussion about these products and to determine whether e-cigarettes deliver promise or peril—or perhaps a bit of both. (See also Viewpoint on e-cigarettes in this issue.)
health at the Centers for Disease Control and Prevention (CDC). But studies consistently reveal that most people who use e-cigarettes are so-called dual users, meaning that they use ecigarettes as well as paper-and-tar cigarettes (Regan AK et al. Tob Control. 2013; 22[1]:19-23; Vickerman KA et al. Nicotine Tob Res. 2013;15[10]:1787-1791; Pearson JL et al. Am J Public Health. 2012;102[9]:17581766). And because smoking-related cardiovascular and cancer risks depend more on how long people smoke than on how much they smoke, dual users are unlikely to gain health benefits from smoking a few less traditional cigarettes each day (Bjartveit K, Tverdal A. Tob Control. 2005;14[5]:315-320). It’s also questionable whether ecigarettes can be a more effective smoking
cessation aid than other nicotine cessation products for smokers who want to quit. The only randomized clinical trial that compared e-cigarettes with conventional nicotine patches found no statistically significant difference in the ability of smokers to quit when they used e-cigarettes or nicotine patches (Bullen C et al. Lancet. 2013; 382[9905]:1629-1637). Even if e-cigarettes could provide benefits to some adult smokers, officials say that the biggest problem with e-cigarettes pertains to adolescents, in whom nicotine use can have harmful effects on brain development. A recent CDC report revealed that the proportion of middle and high school students who have used e-cigarettes doubled to nearly 7%, or almost 2 million, between 2011 and 2012 (CDC. MMWR Morb Mortal
Reed Saxon/AP Images
Less Toxic but Still Dangerous No one questions whether e-cigarettes are less toxic than tobacco-based cigarettes. “It’s a reasonable assumption that if smokers switch completely, it would benefit their health,” said Tim McAfee, MD, MPH, who is the director of the office on smoking and
The use of e-cigarettes has increased sharply in recent years, with revenues doubling every year since 2008.
jama.com
JAMA January 8, 2014 Volume 311, Number 2
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a SUNY Binghamton User on 05/12/2015
123
News & Analysis
Wkly Rep. 2013;62[35]:729-733). Manufacturers say that e-cigarettes are not marketed to children. But e-cigarettes come in flavors such as butterscotch and marshmallow; are seen as hip, modern, and “tech-y”; and are not subject to age restrictions on sales in many states—all attributes that experts suspect could foster use of these devices as a starter product to nicotine addiction for youngsters. Glantz’s recent research involving adolescent e-cigarette users in Korea points to additional concerns (Lee S et al. J Adolesc Health. doi:10.1016/j.jadohealth.2013.11.003 [published online November 22, 2013]). “This was a cross-sectional study, so we have to be careful about making claims about our findings, but we showed that kids using ecigarettes were much less likely to have stopped smoking and were also heavier smokers,” said Glantz. “So contrary to the harm reduction argument, it seems that ecigarettes might not help with quitting and might actually reinforce smoking instead.”
In Need of Regulation Glantz and others are waiting for the US Food and Drug Administration (FDA) to set federal regulations for e-cigarettes. Between 2008 and 2010, the FDA sought to regulate e-cigarettes as drug (nicotine) delivery devices, but e-cigarette companies sued, and the courts ruled in 2010 that e-cigarettes should be regulated as tobacco products. The following year, the FDA announced that it would work to extend its tobacco-related authority to e-cigarettes as tobacco products under the Family Smoking Prevention and Tobacco Control Act (http://1.usa.gov/18zn0Ls). Last year, a proposed rule, which has not been made public, was submitted to the White House’s Office of Management and Budget and Office of Information and Regulatory Affairs for review. The regulations are urgently needed as e-cigarettes gain popularity, with their revenues doubling every year since 2008. In addition to the many adolescents who use ecigarettes, about 21% of adults who smoke traditional cigarettes also use the electronic versions, according to the CDC (King BA et al. Nicotine Tob Res. 2013;15[9]:16231627). But Glantz suspects that because of the time it will take to develop regulations, solicit public comments, and deal with lawsuits from manufacturers, any meaningful FDA rule will take at least several years to establish and implement. And some issues— 124
like indoor public use, taxation, and licensing—will not be addressed by the agency. While the FDA works out its strategy for regulatinge-cigarettes,stateandlocallawmakers are proposing rules of their own. Several states and more than 100 cities have already included e-cigarettes in indoor smoking bans, and others are considering following suit. “Including e-cigarettes in clean indoor air laws is the single most important policy to implement now,” said Glantz. “Doing so will not only protect people from secondhand ecigarette emissions but will prevent the renormalization of public tobacco use.” Some states have labeled e-cigarettes as tobacco products, while others have passed measures that define them as something else, such as “alternative nicotine products” or “vapor products.”
Addressing the Issue With Patients McAfee said that clinicians need to take action aswell.“Asdataareaccumulatingonissuesrelated to e-cigarettes, we can’t just sit on the sidelines while sales to minors, public use, and marketing campaigns go unregulated.”
He noted that information conveyed by cliniciansaboute-cigarettesshouldtakeondifferentforms,dependingonthoseinvolved.For adolescents, the message is clear: e-cigarette use should be discouraged and discussed alongsidetraditionalmessagingabouttobacco use.“Foradultsit’smorecomplicated,”hesaid. “Wedon’twanttodiscouragepeoplefromtrying to quit, but we don’t want to encourage them to get settled in dual-use land.” McAfee is also concerned that continued implementation of strategies that have been proven to lower smoking rates might be stalled or slowed while attention is focused on e-cigarettes. “A big danger is that this will serve as a distraction from getting people off cigarettes,” he said. For now, experts say that the need remains not only for rules about e-cigarette use andmarketing,butalsoforresearchtoprovide definitiveanswersaboutpotentialbenefitsfor people trying to quit smoking and about such potentialharmsasfosteringnicotineaddiction intheyoung,encouragingsmokerstocontinue or resume the habit, or subjecting nonsmokers to secondhand e-cigarette emissions.
CDC: Use of Emerging Tobacco Products Increasing Among US Youths Mike Mitka, MSJ
E
merging tobacco products such as electronic cigarettes (e-cigarettes) and hookahs are gaining popularity among US middle and high school students, although these students’ overall tobacco use remains the same, according to a report on current tobacco use by US youths. The report was issued by the Centers for Disease Control and Prevention (CDC) in the November 15 Morbidity and Mortality Weekly Report (ttp://1.usa.gov/1dGvtwu). Comparing data from the 2011 and 2012 National Youth Tobacco Surveys (http://1.usa .gov/JsRJAk), the CDC researchers found e-cigaretteuseincreasedamongmiddleschool students (grades 6 through 8) from 0.6% to 1.1%; among high school students (grades 9 through 12), e-cigarette use increased from 1.5% to 2.8%. Current use is defined as using 1ormoretobaccoproductsinthepast30days. Hookah use among high school students rose from 4.1% in 2011 to 5.4% in 2012. The researchers also found that cigar use among black high school students increased from
11.7%to16.7%,althoughcigaruseamonghigh school students overall remained statistically the same (11.6% in 2011 and 12.6% in 2012). The CDC report notes that increased use of e-cigarettes and hookahs may be the result of an increase in their marketing, availability, and visibility and the perception that they may be safer alternatives to cigarettes. Hookahs, cigars, e-cigarettes, and certain other new types of tobacco products are not currently subject to US Food and Drug Administration regulation. Although overall tobacco use from 2011 to 2012 decreased from 7.5% to 6.7% among middle schoolers and from 24.3% to 23.3% among high schoolers, the declines were not statistically significant. Use of bidis, thin hand-rolled cigarettes from India and other Southeast Asian countries composed of tobacco and sometimes flavorings, and kreteks (also known as clove cigarettes) from Indonesia, decreased significantly among both middle and high school students in 2012 compared with 2011.
JAMA January 8, 2014 Volume 311, Number 2
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a SUNY Binghamton User on 05/12/2015
jama.com
