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The FDA is still deliberating, but the authors of the new studies have come to their own conclusion: IQOS should not be sold in the United States.
In 30 countries around the world, consumers can slide a roll of dried tobacco into an elegant device, heat it to 350 degrees and inhale it. The result is a nicotine shot that seems to come from a traditional cigarette without producing smoke.
The tobacco giant Philip Morris International wants to sell this device in the United States and is seeking regulatory approval on the grounds that the IQOS system is less dangerous than smoking in the old. However, an independent review of the company's data submitted to the Food and Drug Administration shows that IQOS did not cause less damage than smoking in 23 of the 24 measures. It can even cause health problems other than smoking, including liver disease.
The analysis was led by Stanton Glantz, an enemy of Big Tobacco, who runs the Center for Research and Education on Tobacco Control at the University of California, San Francisco. The results appear in eight articles published Tuesday by the BMJ magazine, Tobacco Control.
The IQOS system has a cylinder in which a blade is pulled through a dried tobacco product called "HeatStick" and heated to 350 degrees. But unlike a cigarette that burns at 600 degrees, a HeatStick never ignites.
That's why Philip Morris and his American partner Altria called IQOS "greenhouse tobacco". The FDA is currently actively examining whether this statement can be made in the United States.
In January, an advisory committee of the FDA agreed that completely switching from cigarette to IQOS significantly reduces the exposure of a smoker to harmful chemicals. But the panel said Philip Morris had not shown that the reduction in exposure would likely result in a "measurable and substantial" decline in the disease and / or the number of deaths.
The FDA is still deliberating, but the authors of the new studies have come to their own conclusion: IQOS should not be sold in the United States.
One of the eight studies challenges the reliability of the tobacco company's claim that, compared to persistent smokers, American smokers who switched to IQOS found an improvement of two dozen "biomarkers" – narrow measures the functioning of organs that often replace health in general. The analysis revealed that virtually no comparison between those who continued smoking and those who changed stores met the statistical standard for protection against moose results.
Of 23 of the 24 measures presented to the FDA by Philip Morris, "the differences are what we could expect based on the simple randomness," wrote Glantz. Instead of applying common statistical conventions and discussing them as part of its submission to the FDA, a Glantz standard called "routine for such a scientific analysis" "Philip Morris Papers" simply points out the direction of change, "he wrote.
This is the kind of statistical hobby with which no regulatory scientist would escape, he added: "No tobacco company would tolerate such claims from the FDA or other public health authorities . "
Another of the studies published Tuesday concluded that in cigarette smokers switched to IQOS, there was no evidence of reduced lung inflammation nor improved function pulmonary.
In his application to the FDA, Philip Morris claimed that lung inflammation was reduced among users of his IQOS product: two biological measures, C-reactive protein and white blood cell count, in smokers who adopted the drug. # 39; IQOS. A UCSF team stated that while these measures are good indicators of systemic inflammation in humans, they are a poor measure of lung function or inflammation of these vital organs. And the analysis of the team suggests that changes in these measures were not very robust either.
This did not prevent Philip Morris from asserting that "smokers who switch to (IQOS) would have a lower risk of chronic obstructive pulmonary disease compared to continuing to smoke," said the research team led by the Dr. Farzad Moazed, specialist in pneumology and critical care. .
The tobacco giant "not only fails to accurately assess lung inflammation in their studies in humans," the researchers wrote, but he also deceptively concludes that their IQOS product reduces Inflammation and the risk of COPD in humans, an assertion that is simply not supported by their data. "
Yet another study warned of adverse effects yet unknown.
Tobacco smoke contains more than 7,000 different chemicals, many of which can cause diseases, including cancer. The FDA has identified 93 harmful or potentially harmful components that it wants tobacco manufacturers to measure in their product emissions.
Philip Morris touted the emissions comparisons of 58 products, including 40 that the FDA has recognized as harmful or potentially harmful. In all these components, IQOS emissions were lower than those of standard cigarette smoke.
The company's chemical analyzes also revealed that IQOS produced concentrations of 56 other constituents at higher concentrations than those found in cigarette smoke. In the case of seven components, HeatSticks have levels at least 10 times higher than those found in cigarette smoke.
These components do not appear on the FDA's list of harmful or potentially harmful components. But the effect of these substances "is not known," wrote the researchers. "Since the components of the HeatSticks may be different from those of the combustible cigarettes, including flavorings and additives, it is plausible that the IQOS aerosol may contain substances not present in tobacco smoke."
"If some impacts of IQOS may be less important than those of cigarettes, others may be just as serious or worse," Glantz said in summarizing the new research. "The evidence does not support Phillip Morris International's extensive claims for harm reduction."
The researchers noted that, in various forms, "heated" tobacco products have been viewed as safer alternatives to cigarettes since the 1960s, and that tobacco companies saw them as a way to circumvent a growing wave of regulation in the world. whole world.
The FDA should have asked Philip Morris to evaluate the attractiveness of the added flavors, as well as the "high-tech look" of IQOS, among young consumers, wrote a team led by Karma McKelvey, researcher at Stanford. His team also asked if Phillip Morris had assumed that IQOS users would give up their smoking habit and turn to fully heated tobacco.
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