Tag: teens and e-cigarettes

04/30/19

Not the End of Smoking

© Tatiana Chekryzhova | 1234rf.com

America’s teens reported a striking increase in their vaping in the previous 12 months, from 27.8 % in 2017 to 37.3% in 2018. Reported vaping in the 30 days prior to the survey almost doubled among high school seniors, going from 11% in 2017 to 20.9% in 2018. Nora Volkow, the director of the National Institute on Drug Abuse (NIDA), said: “Teens are clearly attracted to the marketable technology and flavorings seen in vaping devices; however, it is urgent that teens understand the possible effects of vaping on overall health; the development of the teen brain; and the potential for addiction.” She went on to say research shows that teens who vape may be at risk of transitioning to smoking cigarettes.

The increase in vaping rates for 2017-2018 was consistent with the findings of the National Youth Tobacco Survey, which said e-cigarettes were the most commonly used tobacco product among U.S. middle school and high school students. The most selected reason for e-cigarette use was they were available in flavors like mint, candy, fruit or chocolate. The lead author for the Monitoring the Future study, which annually surveys 12th, 10th and 8th grade students, said in a letter to The New England Medical Journal the increases in the prevalence of vaping nicotine translated into roughly 1.3 million additional adolescents vaping.

Put in historical context, the absolute increases in the prevalence of nicotine vaping among 12th-graders and 10th-graders are the largest ever recorded by Monitoring the Future in the 44 years that it has continuously tracked dozens of substances. These results indicate that the policies in place as of the 2017–2018 school year were not sufficient to stop the spread of nicotine vaping among adolescents. The rapid entry of new vaping devices on the market, the latest example of which is the Juul, will require continual updates and modification of strategies to keep adolescents from vaping and its associated negative health effects.

Scott Gottlieb, the former commissioner of the FDA, who had been active in efforts to thwart this trend, sent 1,300 warning letters over the summer of 2018 to online and brick-and-mortar stores for selling e-cigarette products to underage consumers. He also sent out warning letters to five manufacturers, asking them to address the popularity of their products with underage consumers or risk the removal of “some or all of their flavored products.”  In the letter sent to Juul Labs, the FDA requested that within 60 days, “you provide a written response to this letter that includes a detailed plan, including specific timeframes, to address and mitigate widespread use by minors.” Giving suggestions for that plan, the letter said Juul Labs could:

  • Discontinue sales to retail establishments that have been subject to an FDA civil monetary penalty for sale of tobacco products to minors within the prior 12 months;
  • Develop or strengthen any internal program you have to check on retailers, and report to FDA the name and address of retailers that have sold products to minors;
  • Eliminate online sales, whether through Internet storefronts controlled by your company or other retailers, or provide evidence to demonstrate that your company’s online sales practices do not contribute to youth use of JUUL products;
  • Revise your current marketing practices to help prevent use by minors;
  • Remove flavored products from the market until those products can be reviewed by FDA.

Then unexpectedly, in the middle of his crusade against teen vaping, Scott Gottlieb resigned as the commissioner of the FDA, effective April of 2019. His stated intention was to spend more time with his wife and three daughters. He said: “There’s perhaps nothing that could pull me away from this role other than the challenge of being apart from my family for these past two years and missing my wife and three young children.” Gottlieb said the policies he initiated will move forward as planned, including the proposed restrictions recently announced on the sale of flavored e-cigarette products. The New York Times said retailers were on Capitol Hill lobbying against the FDA proposals. “Conservative groups and vaping trade associations also have come out in opposition, saying that the agency’s efforts to regulate the e-cigarette industry amount to government overreach.” Yet some public health advocates think the action steps were too late.

A December 2018 investigation reported in JAMA Network Open sought to estimate the concentration of tobacco-related toxins among e-cigarette users. Findings suggested that exclusive e-cigarette use resulted in measurable exposure to tobacco-related toxicants, generally at lower levels than with cigarette smoking. Dual users had higher concentrations of exposure to nearly all biomarkers when compared with cigarette-only smokers. “Several biomarkers measured in this study are metabolites of known carcinogens as well as respiratory, cardiovascular and/or reproductive/developmental toxicants.” The data clearly showed e-cigarette users were exposed to known tobacco-related toxicants.

Another study presented at the American College of Cardiology’s 68ith Annual Scientific Session shoed that adults using e-cigarettes are significantly more likely to have a heart attack, coronary disease and depression when compared to nonusers. The study’s lead author said: “Until now, little has been known about cardiovascular events relative to e-cigarette use. These data are a real wake-up call and should prompt more action and awareness about the dangers of e-cigarettes.”

This study found that compared with nonusers, e-cigarette users were 56 percent more likely to have a heart attack and 30 percent more likely to suffer a stroke. Coronary artery disease and circulatory problems, including blood clots, were also much higher among those who vape — 10 percent and 44 percent higher, respectively. This group was also twice as likely to suffer from depression, anxiety and other emotional problems.

Scott Gottlieb said that if the 2019 National Youth Tobacco Survey shows another spike in teen use of e-cigarettes, “We’re going to be back making new policy in the fall.” One of those possible changes could be taking all pod-based e-cigarettes off the market. “At some point, the youth use of those products becomes so intolerable that they have no redeeming public health value, and we’ll just have to sweep the market of those products. And that includes Juul. Those are the products being abused by the children.”

In a statement released on Wednesday, March 13, 2019, Juul Labs said they are committed to reducing youth usage of their products, while preserving their opportunity to “eliminate combustible cigarettes.” They noted how in November of 2018 they stopped the sale of flavored Juul pods to retail stores, strengthened their retail compliance and secret shopper program, enhanced their online age-verification and exited their Facebook and Instagram accounts.

We support category-wide action including the responsible, restricted sale of flavored products and will review today’s draft guidance as we continue to work with FDA, state Attorneys General, local municipalities, and community organizations as a transparent and responsible partner in combating underage use.

So, what is the bottom line on the risks of e-cigarettes for teens? The CDC has a page of “Quick Facts on the Risks of E-Cigarettes.” It said the use of e-cigarettes in not safe for teens and young adults. They contain nicotine, which is highly addictive “and can harm the adolescent brain development.” Young people who use e-cigarettes may also be more likely to smoke cigarettes in the future, which points to the motive underlying Gottlieb’s crusade.

Finally, what about Juul Labs desire to use its e-cigarette to eliminate combustible cigarettes? One of the strongest arguments for vaping is that it can help people taper off from their addiction to tobacco smoking. A group of researchers sought to generate evidence on the ‘real world’ use of e-cigarettes on the quit rates of adult smokers. They recruited 1284 current, established smokers and then re-contacted them after a year. Although 16% had stopped smoking, they found no evidence that electronic nicotine delivery systems (or ENDS) were helping adults quit “at a higher rate than smokers who did not use these products, despite ENDS users being more likely to make a quit attempt.” In other words, they did not put an END to smoking.

Our study suggests that use of current ENDS products in real world conditions do not seem to improve the chances of quitting for smokers, and, under the current landscape, may not be the disruptive technology that increases the population quit rate and reduces the harm of combustibles. Additional steps may be needed to spur innovation to create low-harm and low-risk products that adequately deliver nicotine, address the misperceptions of relative harm of ENDS compared to cigarettes, and encourage cessation and complete switching from combustibles to low-harm and low-risk products among smokers who do not want to quit smoking.

Changes to their design, to how e-cigarettes are marketed and regulated may be too slow and ineffectual to lead to the above changes on their own, according to the lead author of the ‘real world’ study published in PLoS One. But for now, it seems e-cigarettes are more likely to become an add-on to smokers than an effective tool to stop smoking. “People who use both tobacco and e-cigarettes are actually less likely to quit smoking than people who only stick to tobacco.”

09/11/18

JUUL is Not a Gem

licensed under the Creative Commons Attribution-Share Alike 4.0 International license.

An eighteen-year-old waitress was admitted to a Pittsburgh intensive care unit with difficulty breathing, sudden stabbing pains in her chest and a worsening cough. Her condition continued to deteriorate even after the hospital put her on antibiotics. A doctor said: “She was unable to get enough oxygen into her blood from her lungs and required a mechanical ventilator (respirator) to breathe for her until her lungs recovered.” She needed to have fluid drained from her lungs and was diagnosed with hypersensitivity pneumontis, or “wet lung.” Her medical problem was attributed to a two or three week habit of vaping.

Her case study appeared in the medical journal Pediatrics and received local and national media attention. KDKA-TV, which was quoted above, and CNN are just two of the media outlets covering the story. The treating physician and lead author of the case study said chemicals in e-cigarettes led to lung damage and inflammation. “As electronic cigarette use increases, we will be seeing more case reports and side effects.” CNN reported that the 2016 National Youth Tobacco Survey reported that 1.7 million high school students said they had used e-cigarettes in the previous 30 days.

The specific e-cigarette product used by the teen was not mentioned in any of the articles. However, Time and CNBC noted that a product known as “JUUL” accounted for about 33% of the e-cigarette market as of late 2017. The JUUL Labs product has become so popular, that using it is now known as “juuling.” Like tobacco products, JUUL is legally available only for adults 18 and over. But JUUL devices are reported to be wildly popular with teens.

Ironically, the chief administrative officer for JUUL Labs said: “We really don’t want kids using our product.” He said two former smokers created JUUL to help adults quit smoking. However, each JUUL cartridge contains as much nicotine as a pack of cigarettes. The JUUL device fits in the palm of your hand, as illustrated in the above photo. A JUUL starter kit contains the device, four cartridges and a USB charger in order to charge it in a USB port. Time said:

Because of their sleek design and resemblance to USB drives, JUUL products are easy for students to conceal and use in school — sometimes even in the middle of class. (JUULs also produce less smoke than many similar devices, making them even more discreet.) The problem has grown widespread enough that school districts in states including Kentucky, Wisconsin, California and Massachusetts have voiced their concerns and, in some cases, begun amending school policy to address the issue. Some college publications, including those at New York University and the University of Illinois, have also reported on the trend.

In “What is Juul?” Truth Initiative noted that while JUUL Labs says JUUL is just for adults, it comes in flavors that have a proven appeal to young people. And many young people do not realize they are inhaling nicotine with e-cigarettes. A study published in the American Journal of Public Health found that 99% of all the e-cigarettes sold in 2015 contained nicotine. “Youth are more likely to try flavored e-cigarettes, and believe that they are less harmful than tobacco-flavored e-cigarettes.”

In 2015, 16 percent of high school students and 5.3 percent of middle school students used e-cigarettes, the most commonly used tobacco product among U.S. youth. This research provides further evidence that restrictions and warning labels for products containing nicotine are necessary to protect and inform youth.

Truth Initiative did a survey in April of 2018 to assess where teens are getting their hands on JUUL. The most common way was through a store or retail outlet. Another common source was from friends or family members; 52% received JUUL from a social source. Only 6% bought it online, yet “nearly all youth who tried to buy the product online were successful.” Truth Initiative and five other public health and medical groups filed suit in federal court in March of 2018 for the FDA to take action against JUUL.

On April 24, 2018, the FDA issued a statement from Commissioner Scott Gottlieb, who said the FDA “will not tolerate the sale of any tobacco products to youth.” They issued 40 warning letters to retailers known to have sold JUUL products to youth. They also sent an official request to JUUL Labs requiring the company to submit documents related to product marketing and whether certain product features, ingredients or specifications appeal to different age groups. “We don’t yet fully understand why these products are so popular among youth. But it’s imperative that we figure it out, and fast.”

Commissioner Gottlieb said the FDA was planning additional enforcement actions against companies they believed were marketing products in ways that were misleading to kids. These were just the first in a series of efforts within the FDA’s newly formed Youth Tobacco Prevention Plan. He hoped this sent a clear message to all tobacco product manufacturers and retailers. “If kids are flocking to your product or you’re illegally selling these products to kids, you’re on the agency’s radar.”

The youth-focused steps we’re taking are consistent with our responsibility to protect kids and significantly reduce tobacco-related disease and death, and I intend to do everything within my power to fulfill that duty.

Then on May 17, 2018 and again on June 21, 2018 the FDA sent out official requests to a total of six additional e-cigarette manufacturers requiring them to submit information like that requested of JUUL Labs to help the agency better understand the youth appeal to these products. The companies had until July 12, 2018 to respond to the FDA. The companies were selected based on product attributes that overlapped with those of JUUL. These attributes included the use of e-liquids with high nicotine concentration; a small size, making them easily concealable; and intuitive product design features for ease of use. Commissioner Gottlieb said:

Too many kids continue to experiment with e-cigarette and vaping products, putting them at risk for developing a lifelong nicotine addiction. These products should never be marketed to, sold to, or used by kids and it’s critical that we take aggressive steps to address the youth use of these products. This includes taking a hard look at whether certain design features and product marketing practices are fueling the youth use of such products.

A study published in PLOS One by Weaver et al. said ENDS (electronic nicotine delivery systems) were not helping adult smokers quit. The study randomly sampled 1,284 adult smokers in August/September of 2015 and re-contacted them one-year later. Adults who didn’t use ENDS were more likely to have quit smoking at the end of the study than those who has used ENDS at some point during the study. The researchers, Weaver et al., said:

We found no evidence that ENDS use, within context of the 2015–2016 US regulatory and tobacco/vaping market landscape, helped adult smokers quit at rates higher than smokers who did not use these products. Absent any meaningful changes, ENDS use among adult smokers is unlikely to be a sufficient solution to obtaining a meaningful increase in population quit rates.

The Wall Street Journal quoted the lead author of the study as saying, “These products have not been fulfilling the public health promise of helping people in the U.S. quit smoking.” He added that changes in design, marketing and regulation may help them become more effective as smoking cessation tools. The researchers speculated that older ENDS might be ineffective because they fall short of the “real world” of smoking. It other words, they don’t have a high enough nicotine content to tempt smokers to switch from cigarettes completely. Disturbingly, while this speculation is not yet supported by research, it could be used to present higher nicotine ENDS like JUUL as harm reduction tools, subtly changing the public health dialogue away from smoking cessation. “Any amount of smoking is harmful, and it’s really not benefiting them if they don’t quit entirely.”

The senior author of the study was alarmed with the large percentage of dual users noted at the end of the study. More than half of those who also vaped at the beginning of the study were still smoking a year later. And over half of those smokers were also vaping. The study also found that none of the flavors used in ENDS other than menthol or mint were associated with lower odds of quitting when compared to non-ENDS users. “We need to be much more consistent in our guidance to smokers about how to use these products and that they need to quit smoking and avoid dual use.”

NPR noted how San Francisco banned the sale candy-flavored e-cigarettes, “but a tobacco industry-funded campaign” forced a voter referendum on the ban. The measure, known as Prop E, was opposed by “No on Prop E,” which received its funding from R.J. Reynolds—“to the tune of nearly $12 million.” Some of their slogans included “bans don’t work” and “voting no preserves adult choice.” The referendum took place on June 5, 2018, wheere Prop E was soundly supported, with 68% voting “yes” on Prop E to ban candy-flavored e-cigarettes.

Surprisingly, on January 5, 2018, Philip Morris International announced its plan to stop selling cigarettes in Britain at an unspecified future date. The managing director of PML said: “We believe we have an important role to play in helping the U.K. become smoke-free.” Yet like other tobacco companies, Philip Morris has been developing alternatives to conventional cigarettes. The company currently sells a technology called iQOS in about 24 countries. “It heats tobacco without burning it, reducing levels of harmful chemicals found in cigarette smoke.”

Former Philip Morris employees and contractors told Reuters about “a number of irregularities” in the clinical trial studies submitted by the company in its application to the FDA for approval of its iQOS device. One principal investigator failed to get informed consent from participants, a basic procedure during clinical trials, and the experiment had to be excluded. A review of hundreds of pages of publically available study reports also uncovered “shortcomings in the training and professionalism of some of the lead investigators, as well as their knowledge of the study results.”

A group of tobacco research and policy experts reviewed detailed summaries of Reuters’ reporting and Philip Morris’ response. The experts, including a former head of the FDA and two former scientific advisers for the agency, said those findings raise concerns about Philip Morris’ clinical trial program.

The New York Times reported on January 25, 2018 that an advisory committee recommended the FDA reject the Philip Morris International application to market the iQOS as safer than traditional cigarettes by an eight-to-one vote. The committee rejected the company’s claim that “scientific studies have shown that switching completely from cigarettes to the IQOS system can reduce the risks of tobacco-related diseases.” Although the committee did agree the device would limit exposure to the harmful chemicals in conventional cigarettes, it expressed doubt smokers would completely switch to use only iQOS. Rather, many on the committee thought smokers could become long-term dual users of the device and cigarettes.

An FDA decision on IQOS had not been made public by the beginning of July. But Reuters noted that ten U.S. Senators sent a letter to FDA Commissioner Gottlieb in February of 2018 calling on the agency to reject the Philip Morris application to market the iQOS device as less risky than cigarettes. They encouraged the FDA to avoid rushing through new products like the iQOS  “without requiring strong evidence that any such product will reduce the risk of disease, result in a large number of smokers quitting, and not increase youth tobacco use.” A thorough review of the application was “especially critical given the tobacco industry’s deceitful history of marketing products under the guise of lower risk.” So far, the company has spent more than $3 billion developing new smoking technologies like iQOS.

JUUL Labs just announced it will sell cartridges with 40% less nicotine beginning in August of 2018. Initially only mint and Virginia tobacco flavored JuulPods will be available in the lower nicotine cartridges. In October there will be a wider release. I wonder if they will offer their top selling fruity flavored cartridges in a lower nicotine option?

The Verge noted JUUL Labs carefully avoided saying whether the lower nicotine cartridge will eventually lead to no nicotine at all. The company describes its product as a “switching tool” to help adults stop smoking cigarettes. And a 40% reduction isn’t enough to make JUUL less addictive. An expert said nicotine levels would have to be cut by 85 to 95 percent to make cigarettes (and by implication JUULs) significantly less addictive. If the company goal is to get smokers to switch from cigarettes to JUUL, cartridges with low enough concentrations of nicotine to be less addictive and a real harm reduction technology are unlikely.

Public health efforts have drastically curtailed the use of tobacco and cigarettes over the past several decades. Cigarette use has become stigmatized. So companies like Philip Morris International and JUUL Labs are trying to position their new nicotine delivery systems as harm reduction devices. But they may be as bad for you as the tobacco products they seek to replace. JUUL and iQOS are not really public health gems.