In 30 countries/regions around the world, consumers can slide a roll of dried tobacco into a smooth device, heat it to 350 degrees and inhale it. The result is a bite of nicotine, which feels like it comes from a traditional cigarette without producing any smoke.
Tobacco giant Philip Morris International hopes to sell this device in the United States and is seeking regulatory approval on the grounds that the IQOS system is less dangerous than old-fashioned smoking. But an independent review of company data submitted to the U.S. Food and Drug Administration revealed that IQOS caused no less harm than cigarettes in 23 of the 24 measures. It may even cause some health problems that cigarettes do not, including liver disease.
The analysis was led by Stanton Glantz, an enemy of Big Tobacco, who heads the Center for Tobacco Control Research and Education at the University of California, San Francisco. The research results were published in eight papers published on Tuesday in the BMJ magazine "Tobacco Control".
The IQOS system has a cylinder in which the blade passes through a dried tobacco product called a "heating rod" and is heated to 350 degrees. But unlike cigarettes that burn at 600 degrees, the heating rod will never ignite.
This is why Philip Morris and his US partner Altria call IQOS a "harm reduction" tobacco product. The FDA is now actively reviewing whether this statement can be made in the U.S.
In January of this year, an FDA advisory panel agreed that switching from cigarettes to IQOS altogether could significantly reduce smokers’ exposure to harmful chemicals. But the panel said that Philip Morris did not prove that reduced exposure could lead to a "measurable and substantial" decline in illness and/or death.
The FDA is still under review, but the authors of the new study have come to their own conclusion: IQOS should not be sold in the United States
One of the eight studies challenged the reliability of tobacco companies’ claims that, compared with persistent smokers, American smokers who switched to IQOS saw an improvement of 20 dozen “biomarkers”—a narrow measure of organ function Standards are usually used as a substitute for overall health. The analysis found that, in fact, the comparison between continued smokers and quitters did not meet the statistical criteria for preventing fluke results.
Glantz wrote that in 23 of the 24 measures Philip Morris submitted to the FDA, "the difference was within the expected range based on simple randomness." He wrote that Philip Morris’ documents did not apply common statistical conventions and discussed them in the documents submitted to the FDA-a standard Glanz called "the routine of scientific analysis of this type"- The Philip Morris document "only emphasizes the direction of change."
He added that this is a statistical scam that no regulatory scientist can escape: "No tobacco company will tolerate such assertions by the FDA or other public health authorities."
Another study published on Tuesday concluded that among smokers who switched to IQOS, there was no evidence of reduced lung inflammation or improved lung function.
In claiming reduced lung inflammation in people using its IQOS products, Philip Morris submitted a document to the FDA citing improvements in two biological indicators in smokers who switched to IQOS-C-reactive protein and white blood cell count. A team from the University of California, San Francisco accused that although these measures are good indicators of human systemic inflammation, they are not a good measure of lung function or inflammation of these vital organs. The team's analysis shows that the changes in these measures are not very strong.
The research team led by Dr. Farzad Moazed, an expert in lung and intensive care, noted that this did not stop Philip Morris from claiming that “smokers who switch to [IQOS] have a lower risk of chronic obstructive pulmonary disease compared with continuing to smoke.” .
The researchers wrote that the tobacco giant “not only failed to accurately assess lung inflammation in their human studies,” but “also misleadingly concluded that their IQOS products can reduce inflammation and COPD in humans. Risk, this claim is not supported at all. Their data."
Another study warned about unknown adverse effects.
Tobacco smoke contains more than 7,000 different chemicals, many of which can induce diseases, including cancer. The FDA has identified 93 harmful or potentially harmful ingredients, and it expects tobacco product manufacturers to measure the emissions of their products.
Philip Morris touted the emission comparisons of 58 products, of which 40 were identified as harmful or potentially harmful by the FDA. Among all these ingredients, it found that IQOS emissions are lower than standard cigarette smoke.
However, the chemical analysis of the tobacco company also found that the concentration of 56 other components produced by IQOS is higher than the concentration in cigarette smoke. In the case of seven ingredients, the emission level of HeatSticks is at least 10 times higher than the level in cigarette smoke.
These ingredients are not included in the FDA's list of harmful or potentially harmful ingredients. But the researchers wrote that the role of these substances is "not yet clear." "Because the composition of the heating rod may be different from that of combustible cigarettes, including flavors and additives, IQOS aerosols may contain substances that are not present in tobacco smoke."
"While some of the effects of IQOS may be lower than cigarettes, other effects may be just as bad or worse," Grants said in summarizing the new research. "The evidence does not support Philip Morris International's broad claim to reduce harm."
Philip Morris International disputed many of the allegations made by Grants and his colleagues by pointing to other studies in a large number of documents submitted to the FDA.
Philip Morris International’s vice president of science and public communications, Moira Gilchrist (Moira Gilchrist) said: “The problem we encountered was that we conducted a very selective analysis using selective data and found that The conclusion does not consider all the evidence." "We do not rely on one, two or a small group of studies. We conducted 18 non-clinical studies. We conducted 10 clinical studies, two of which have been submitted as amendments to the application These (newly published) papers made very microscopic and individual observations on a subset of this information, and frankly, we strongly disagree with the conclusions reached."
For example, Gilchrist points out that Glantz found that studies that lack statistical significance were not designed to measure clinical biomarkers of study participants. She said that after measuring them, the results were "very encouraging, and we included them." A later study aimed at capturing these results and submitted to the FDA in early June found that five of the eight "clinical risk" indicators were statistically significant.
Researchers point out that since the 1960s, "heated" tobacco products have been touted as safer alternatives to cigarettes in various forms, and tobacco companies see it as a means to circumvent the global regulatory wave.
A team led by Stanford University researcher Karma McKelvey wrote that the FDA should ask Philip Morris to assess the appeal of flavoring and the appeal of IQOS’s “high-tech appearance” to young consumers. Her team also questioned whether a key assumption made by Philip Morris-that IQOS users will abandon their smoking habit and switch to heated tobacco altogether-is true.
The tobacco giant claims that providing safer tobacco products depends on whether current smokers turn to IQOS in large numbers. However, McKelvey's team wrote that this possibility has not yet been tested and is "inconsistent with [Philip Morris]'s own evidence on how consumers will actually use IQOS and the existing epidemiological evidence for related products."
The results of the study "show that the introduction of IQOS will cause adolescents and young non-users to start using IQOS tobacco, and may also increase the mixed use of IQOS with other tobacco products."
October 24th at 6:50 am: This article has been updated with Philip Morris International's response.
This article was originally published on October 23rd at 4:05 pm
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Melissa Healy is a health and science reporter for the Los Angeles Times, from Washington, DC. She covers prescription drugs, obesity, nutrition and exercise, as well as neuroscience, mental health, and human behavior. She has worked in The Times for more than 30 years, covering national security, environment, domestic social policy, Congress and the White House. As a baby boomer, she is keenly aware of the trend of middle-aged weight gain, memory loss and the health benefits of red wine.
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