The FDA is still advising, but the authors of the new studies have come to their own conclusion: IQOS should not be sold in the US
In 30 countries around the world, consumers can slip a roll of dried tobacco into a foil-lendish device Heat to 350 degrees and breathe in. The result is a nicotine hit that feels like it comes from a traditional cigarette without producing smoke.
The tobacco giant Philip Morris International wants to sell this device in the United States and seeks approval with the IQOS system is less dangerous than old-fashioned smoking. But an independent review of company data at the Food and Drug Administration shows that IQOS does no less harm than cigarettes in 23 out of 24 measures. It can even cause some health problems that cigarettes do not have, including liver disease.
The analysis was led by Big Tobacco Enemy Stanton Glantz, who heads the University of California, San Francisco Center for Tobacco Control Research and Education. The results appear in eight published on Tuesday publications 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 US partner Altria IQOS call a "reduced harm" tobacco product. The FDA is actively investigating whether this claim can be asserted in the US.
In January, an FDA advisory panel agreed that a complete change from cigarettes to IQOS would significantly reduce the exposure of smokers to harmful chemicals. But the panel said Philip Morris did not show that the reduced exposure would likely lead to a "measurable and substantial" decline in disease and / or death.
The FDA is still advising, but the authors of the new studies have reached their own conclusion: IQOS should not be sold in the US
One of the eight studies questions the reliability of the tobacco company's claim that American smokers, the have switched to IQOS, compared to smokers improvements in two dozen "biomarkers" have observed organ function measures that often serve as a replacement for overall health. Virtually none of the comparisons between those who continued to smoke and those who switched satisfied the statistical standard that protects against Fluke, the analysis revealed.
On 23 of 24 readings submitted by the FDA by Philip Morris, "differences are expected to be due to simple randomness," Glantz wrote. Instead of applying the usual statistical conventions and discussing them in their submission to the FDA ̵
It's the kind of statistical right that no regulatory scientist would get away with, he added, "No tobacco company would tolerate such allegations from the FDA or other health authorities."
Another study published on Tuesday found that cigarette smokers had been switched. There was no evidence of decreased pneumonia or improvement in lung function in IQOS.
Philip Morris & # 39; s petition for approval of reduced lung inflammation in patients using his IQOS product cites improvements in two biological scales _C-reactive protein and white blood cell count _ in smokers who have switched to IQOS. A team from UCSF found that while these measures are good indicators of systemic inflammation in humans, they are a poor measure of lung function or inflammation in these vital organs. And the team's analysis suggests that changes in these measures were also not very robust.
That did not stop Philip Morris from "smokers switching to (IQOS) have a lower risk of chronic obstructive pulmonary disease than smoking." The research team, led by Drs. Farzad Moazed, specialist for lung and intensive care medicine.
The tobacco giant "does not fail to accurately assess pneumonia in its human studies," the researchers write, "but also misleading," concludes that their IQOS product reduces inflammation and the risk of COPD in humans, an assertion that simply is not supported by their data.
Yet another study warned of unknown side effects.
Tobacco smoke contains over 7,000 different chemical substances, many of which are capable of causing disease, including cancer.The FDA has identified 93 harmful or potentially harmful components that tobacco manufacturers want to measure in emissions from their products.
Philip Morris has propagated emission comparisons of 58 products, including 40 that are considered harmful or harmful by the FDA, to be potentially harmful, with lower levels of IQOS emissions in all of these components But the tobacco company's chemical analyzes also found that IQOS produced concentrations of 56 different components at higher concentrations than cigarette smoke, and in the case of seven components, the HeatSticks emitted concentrations at least 10 times higher than in cigarette smoke those found in cigarette smoke.
These ingredients are not included in the list of harmful or potentially harmful ingredients of the FDA. But the effect of these substances "is not known", the researchers wrote. "Since the components of HeatSticks may differ from those of flammable cigarettes, including flavorings and additives, it is plausible that the IQOS aerosol contains substances that are not found in tobacco smoke."
"While some effects of IQOS may be lower than those of cigarettes, others may be as bad or worse," Glantz said, summing up the new research. "The evidence does not support Phillip Morris International's widespread notion of harm."
Researchers noted that "heated" tobacco products have been touted in various forms as safer alternatives to cigarettes since the 1960s and that tobacco companies have seen them serve to circumvent a growing tide of regulations worldwide.
The FDA should have demanded from Philip Morris to evaluate the appeal of supplemental flavors as well as the "high-tech appearance" of IQOS for younger consumers, he wrote a team led by Stanford researcher Karma McKelvey. Her team also asked if an important assumption by Phillip Morris that IQOS users give up their cigarette habit and switch completely to heated tobacco is true.