E-cigarettes are risky. Why does the FDA authorize e-cigarettes? - New York Times

2021-12-01 08:25:09 By : Mr. lee Mr

The agency has taken a controversial stance on using e-cigarettes as a way to quit smoking. This is what the research shows.

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When they first appeared in the United States in the mid-2000s, "electronic nicotine delivery systems"—e-cigarettes, e-cigarettes, e-liquids, and other commodities containing stimulants found in tobacco—were almost unsupervised by the federal government. Their manufacturers can add countless other ingredients and condiments. Just like the cigarettes before them, these devices are extremely attractive to young people. In 2018, surgeons declared e-cigarette smoking among teenagers to be an “epidemic” and pointed out that one in five high school students and one in twenty middle school students use e-cigarettes. Nicotine can harm the developing brain, e-cigarettes contain potentially harmful toxins such as heavy metals; the long-term effects of e-cigarettes—heating nicotine to produce inhaled aerosols—are uncertain.

Despite these concerns, US public health officials hope that if there is a choice on the open market, people who are already addicted to nicotine will choose e-cigarettes instead of cigarettes-a deadly consumer product that has been so successful in attracting and retaining users. , So much so that as many as 24 million Americans have been killed in the past 60 years. Since e-cigarettes generally contain fewer toxic chemicals than tobacco smoke, they are considered less harmful than cigarettes. The theory believes that if a considerable number of one in seven smoking adults in the United States switch to e-cigarettes, then the number of people suffering from cancer, cardiovascular and respiratory diseases may be significantly reduced.

In 2016, in order to reduce the potential harm of e-cigarettes, the U.S. Food and Drug Administration began to regulate it as a "new tobacco product". It is illegal to sell e-cigarettes to anyone under the age of 18 (the national deadline rose to 21 at the end of 2019), and the agency has the right to request warning labels. The FDA also gained the power to exclude products from the market unless it can be proven that their public health benefits outweigh their risks. (Due to legislation passed in 2009, this condition generally applies to new tobacco products; the cigarettes themselves and other tobacco products on the market before February 15, 2007 do not have to meet the same standards.) As of last month, the agency has rejected nearly one Millions of applications. However, after the FDA announced that the data submitted by its manufacturers indicated that they were indeed less toxic than cigarettes, and, in the words of the agency’s press release, “benefited adult smokers who quit smoking,” it approved an evaporation. And two tobacco-flavored liquids into these products. This will "exceed the risks to young people" and lead to comprehensive "protection of public health."

This decision is controversial. Part of the reason is that research on whether electronic products can help adult smokers quit smoking has shown mixed results at best. For example, in October, the same month as the FDA’s ruling, JAMA Network Open published a study that “found no evidence that switching to e-cigarettes can prevent recurrence of smoking,” said lead author and retiree John P. Pierce Professor of the Herbert Wertheim School of Public Health and Human Longevity, University of California, San Diego. He and his colleagues analyzed data from the Tobacco and Health Research Population Assessment, a longitudinal study of tobacco use in the United States started in 2013 by the National Institutes of Health and the FDA. Based on the response to 2017, the researchers identified 13,604 participants. Smoker. When these participants were surveyed a year later, 9.4% reported that they had quit smoking.

The PATH study does not attempt to determine the methods people use to quit smoking; it only asks what tobacco products they consume after quitting, if any. Then, after another 12 months, it checked whether they had completely quit smoking; they had relapsed and quit again; or they had re-smoked. After controlling for potential confounding factors (such as nicotine dependence), the JAMA team concluded that the number of people who used any alternative tobacco products after quitting smoking, including e-cigarettes (also cigars, hookahs, etc.) increased 8.5% are more likely to relapse than those who have not relapsed. The proportion of daily e-cigarette users and quitters who smoke again is roughly the same: slightly more than one-third. In other words, e-cigarettes do not seem to be more successful than cold turkey in preventing re-smoking.

But there are other researchers who believe that, taken together, the existing evidence suggests that e-cigarettes may be beneficial to public health. In September, before the FDA approved any e-cigarette products, a group of researchers listed this evidence in the American Journal of Public Health. The research they cited included a randomized controlled trial conducted in the UK and published in the New England Journal of Medicine in 2019, which found that participants who wanted to quit smoking and switched to e-cigarettes were 80% more likely to quit smoking Compared with people using a range of nicotine replacement therapies (such as patches, gum, and lozenges), at least one year.

The authors of AJPH believe that discoveries like this show that e-cigarettes can help smokers under certain conditions—participants have received behavioral support, which increases the success rate of smoking cessation attempts—are underestimated, and are less effective for young people. The risk has been underestimated and magnified. "The message there is that these hazardous devices shouldn't exist at all," said one of the authors, Nancy A. Rigotti, a professor at Harvard Medical School and director of the Massachusetts Tobacco Research and Treatment Center. "The truth is more complicated."

Controlled trials do not always show what happens in the real world—this is exactly what the JAMA study is trying to evaluate. However, Rigotti and others believe their conclusions are misleading. "The important thing here is whether e-cigarettes help some smokers who wouldn't do it otherwise?" Kenneth E. Warner, Professor Emeritus and Chair of the Department of Health Management and Policy, University of Michigan School of Public Health, and co-author of the AJPH paper (Kenneth E. Warner) said. The JAMA study found that those who rely on nicotine the most may have the hardest time to quit smoking and are most likely to use e-cigarettes. But it is unclear whether the group would continue to smoke without e-cigarettes—in this case, e-cigarettes would increase the total number of smokers—or whether its members would try to quit nicotine. Without this information, it is not clear whether e-cigarettes can become a valuable tool for quitting smoking, which can attract some deep-rooted smokers to quit.

Adult smokers do want to quit smoking: In 2018, about 55% of respondents said they had tried to quit smoking in the past year; according to the CDC, there was only a 7.5% success rate, if any, the JAMA study, regardless of How you analyze it shows how difficult it is to stay smoke-free. "In terms of quitting smoking, we haven't seen a game-changing thing," said Jonathan M. Summit, dean and professor of the Colorado School of Public Health. Obviously, smokers need more resources, said Alayna P. Tackett, an assistant professor at the Keck School of Medicine at the University of Southern California: "They are trying to quit smoking. They want to quit. How can we best support them?"

In the United States, it is difficult to say whether e-cigarettes can play a greater supporting role. Available products are constantly changing, and e-cigarettes are not classified as "quit smoking devices." This label requires manufacturers to pass the FDA's drug evaluation and research process-they have little incentive to do it. Therefore, e-cigarettes cannot be promoted to smokers as a means for companies to quit smoking or as a treatment certified by health officials. The weird consequence is that for e-cigarettes to have a wide-ranging positive impact on public health—the FDA has expressed its hope to approve what they do—smokers will have to decide to switch to them to a large extent. "Regulatory chaos is not good for us," said Terry F. Pechacek, a research professor in the Department of Health Policy and Behavioral Sciences at the Georgia State University School of Public Health, who wrote reviews for the JAMA study. "This is the core of the problem."

Kim Tingley is a contributing writer for the magazine.