- Philip Morris International (PMI) presented their ninth clinical study on the heat-not-burn IQOS device at the fifth annual Global Forum on Nicotine
- The six-month study showed improvement in health outcomes including lung function and inflammation in smokers who transitioned to IQOS
- U.S. regulators are skeptical of the technology and have yet to approve it for domestic sale
WARSAW, Poland — A new clinical study comparing combustible cigarettes with heat-not-burn technologies found smokers who make the switch significantly improve their future health outcomes.
The research, presented Friday by scientists from Philip Morris International (PMI) at the fifth annual Global Forum on Nicotine in Warsaw, Poland, compares the biological responses of active smokers with those who transition to their smoke-free tobacco product IQOS. Researchers measured health outcomes that are generally expected to improve after six-months of smoking abstinence.
Scientists ultimately chose eight clinical endpoints to study, such as lung function, clotting and genotoxicity, which are most associated with disease in smokers. They found statistically significant improvements in five of the eight endpoints in IQOS users after six months, including lung function and inflammation. All eight endpoints moved in a positive direction, similar to improvements seen after smoking cessation, according to the researchers.
Leading independent public health scientists say they are encouraged by the latest data on the IQOS, which offers smokers who struggle to quit with an electronic cigarette an additional avenue.
“I think there is no doubt IQOS is much safer than a tobacco cigarette,” Dr. Konstantinos Farsalinos, a research fellow at Onassis Cardiac Surgery Center in Kallithea, Greece, told The Daily Caller News Foundation. “There is a strong reduction in the levels of toxic emissions.”
The data bolsters a previous 90-day exposure study from PMI scientists, which reportedly found the aerosol produced by IQOS reduces carbon monoxide exposure by 98.7 percent and exposure to acrolein by 94.2 percent when compared with a traditional cigarette. Carbon monoxide and acrolein are identified as two of the most harmful toxicants produced by cigarettes by both the U.S. Food and Drug Administration and the World Health Organization.
For the latest research, which PMI submitted on June 8 to the FDA, scientists conducted a six-month randomized study of 984 U.S. adult smokers. 496 were given an IQOS product while the other 488 continued smoking combustible cigarettes.
Notably, the study allowed the group of IQOS users to freely use other tobacco and nicotine products in order to achieve a more realistic result. Despite intermittent duel-use of combustible cigarettes with the group using IQOS, they experienced overall improvement in health outcomes, according to the researchers.
“We believe this study on IQOS is the first ever clinical study of this magnitude to directly assess the risk-reduction potential of a smoke-free product in people who switch to it,” Frank Luedicke, chief medical officer for PMI, said in a statement Friday. “Everything we’ve seen, including these new results, continues to point in the direction of risk reduction. We are sharing the results with the scientific community at multiple conferences over the next few months and we look forward to their feedback.”
Unlike a traditional e-cigarette, which vaporizes nicotine fluid, the IQOS heats tobacco leaves. Users insert sticks resembling short cigarettes called Heets into the device’s blade, which heats a concentrated dose of tobacco, eliminating the more harmful process of combustion. (RELATED: The Largest Tobacco Company In The World Is Betting Their Future On High-Tech Alternatives To Cigarettes)
Critics of alternative smoking technologies like the IQOS say that while short-term results may be positive, the long-term effects of using this product are unknown.
“Smoking-related diseases take decades to develop,” Dr. Patrick Picavet, director of scientific and medical affairs for PMI Research and Development, told TheDCNF. “It’s not feasible, not in a pre-market setting but also from a time perspective, to get to the point where you would be assessing morbidity and mortality rates for a product like IQOS, because then we would have to wait 20 years while people continue to smoke.”
The American Cancer Society, which is historically critical of harm reduction technologies, recently endorsed the use of alternative smoking devices for adult smokers as a way to “reinvigorate smokers’ understanding of the importance of quitting combustible tobacco.” The ACS says “the health impact on users is not yet known” regarding IQOS; however, they acknowledged the company’s claim that users who transition off cigarettes to the device may be reducing their exposure to harmful chemicals.
PMI claims the aerosol produced by the IQOS contains roughly 90 to 95 percent lower levels of toxins than combustible cigarettes. They have invested more than $4.5 billion since 2008 to develop reduced-risk alternatives.
In his own research, Farsalinos found the IQOS is “emitting about 80 to 90 percent less emissions than a tobacco cigarette.”
Representatives for PMI stress that the product is not harmless and is not intended for non-smokers or people who have quit combustible cigarettes. Farsalinos says it is important that smokers know the differences in risk between various alternative smoking technologies.
“From the research we’ve seen there are strong reductions in toxic emissions from IQOS, but the e-cigarette is even less harmful than IQOS,” Farsalinos told TheDCNF. “So there is a risk continuum even among these alternative products, and I think smokers need to know that in order to make an informed decision. Of course the first priority is to quit smoking. My suggestion is the first choice should be a new generation e-cigarette, and if they fail with that, yes, it’s perfectly fine to try IQOS or any other heated tobacco product.”
The FDA is currently reviewing a premarket tobacco application that would allow the IQOS to be sold in the U.S., as well as a Modified Risk Tobacco Product (MRTP) application, which will determine if the IQOS can be billed as a safer alternative to smoking.
The FDA has not given any indication on when they will make a ruling regarding the applications.
“I think the IQOS will be approved for marketing,” said Farsalinos. “The best they can hope for is a reduced exposure claim. I’m almost certain they will not get a reduced-risk claim and labeling, but I think marketing is good enough. As in every country where it’s available, it will be an additional aid for U.S. smokers who have failed to quit with e-cigarettes.”
PMI estimates more than five million former smokers in 40 different markets across the world have completely quit combustible cigarettes by transitioning to the IQOS.
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