The IQOS gamble
Philip Morris’s state-of-the-art research facility could revolutionize the smoking industry
It is far from clear whether Philip Morris International (PMI) has found the silver bullet of harm-reducing cigarettes, but their state-of-the-art research facility, perched next to Switzerland’s tranquil Lake Neuchatel, is working toward that goal.
Inside the $120 million facility, hundreds of scientists are hard at work to prove that IQOS can be a “harm reducer” for addicted smokers.
Simon Dowding, manager of PMI’s “Smoke-Free” Campaign, says the facility is all about eliminating fire, burning and smoke from its IQOS product. Dowding, originally from Australia, said that when he joined PMI in 2014, “one of the reasons... was very much a journey with a company in marketing to pursue a smokefree future” – though he does not smoke cigarettes or use IQOS.
PMI is working hard to get the world to believe that its IQOS product, released in Israel in December after years of massive investment, is a “potential harm reducer” for smokers who are already hooked. Harm reduction for addicted smokers, if true, would mean that while IQOS could still harm the health of non-smokers, it could potentially be less harmful than regular cigarettes for people who already smoke.
There is a “HEET” or cigarette-look-alike inside the IQOS holder, but it’s far different from a cigarette. Maayan Sarig, PMI’s spokesperson in Israel, explains that the refill – which comes in a pack of 20 and contains a mixture of tobacco, nicotine, and flavorings – is not lit by a match or a lighter.
Instead, it uses the specially designed holder to heat the tobacco, instead of burning it, said Sarig. In theory, because there is no combustion, the otherwise harmful compounds are less harmful.
The US Food and Drug Administration is currently reviewing PMI’s two-millionpage application of scientific studies to get IQOS accepted as a “harm-reducing measure.” The FDA’s decision is expected sometime by 2019.
Dr. Nuno Fazenda, PMI’s manager of scientific engagement, claims that IQOS reduces the negative impact of harmful chemicals “by 90% compared to regular cigarette smoke.” Another 15 carcinogenic compounds, according to PMI, are reduced by 95%.
Fazenda, originally from Portugal, holds a PhD from the Swiss Federal Institute of Technology and worked in the medical devices industry before joining PMI in 2011. The 90% claim is based on studies done regarding the reduction of harm for 58 out of 93 compounds compiled by four major health organizations, including the FDA. Its studies do not cover the other 35 compounds.
PMI has conducted four clinical studies that seem to confirm that IQOS users have “significantly reduced exposure to 15 toxicants,” including benzene, butadiene, acrolein and carbon monoxide.
However, critics refer to a May 2017 study in the prestigious JAMA Internal Medicine journal and a February 2017 Aerosol Science and Technology Journal study that claimed whatever PMI has reduced in terms of carcinogens in IQOS, it still has chemicals in higher concentrations than previously reported. In fact, lead author Dr. Reto Auer of the JAMA study said that “there is no safe minimum limit” for some of these dangerous chemicals.
Regarding PMI’s clinical studies, Hadassah School of Public Health physician Hagai Levine points out, “We are really interested in health effects, not chemicals. It will take many years to assess the exact magnitude of morbidity and mortality risk for IQOS users.”
But Dowding adds: “If we were not serious about the science, we would not be sending it to the US Food and Drug Administration.” According to Fazenda, the studies have proven that IQOS “does not adversely affect indoor air quality” and is “not a source of second-hand smoke.”
It is worth noting that both the JAMA and Aerosol Science studies said that, based on their findings, IQOS should fall under the same indoor smoking bans in place for conventional cigarettes.
Asked why the public should trust the tobacco companies - considering their history of misrepresentation regarding the harm caused by cigarettes - PMI urged consumers to trust the science.“It is not really about trusting the company,” said Fazenda. “We encourage independent verification of our science.”
PMI Israel’s IQOS campaign includes the pitch: “A better alternative to continued cigarette smoking.” Explaining the slogan, Sarig cited the 90% statistic, contending that “switching completely to IQOS is likely to present less risk of harm than continuing to smoke cigarettes,” and that “IQOS has no negative impact on indoor air quality.” She acknowledged, though, that “IQOS is not risk free.”
Dr. Leah Rosen, director of health promotion at Tel Aviv University’s School of Public Health, is a critic of PMI’s marketing campaign. She says that the US currently prohibits the sale of IQOS with the claim that it reduces harm. “That is because in the US they are not willing to blindly accept claims of the tobacco industry, given the history of truthfulness of the industry,” Rosen said.
PMI Israel started distributing IQOS locally in December 2016. Initially it was unregulated and untaxed, but following a petition to the High Court of Justice by PMI competitor Dubek, Israel’s major domestic manufacturer of regular cigarettes, the Health Ministry in March ordered that IQOS be regulated and taxed like regular cigarettes.
PMI general manager Daniel Elfen responded to the High Court petition. “The number of smokers in Israel increased in 2016 and some cigarette manufacturers,” he said in reference to Dubek, “are very satisfied maintaining this status quo.
“Most smokers continue to smoke and giving them only two choices – to quit or keep smoking – is no longer the only viable strategy now that products presenting less harm are available,” said Elfen. He hopes that Israel’s Health Ministry will “align with the position of numerous countries and the European Union.”
PMI noted that IQOS is already sold in 25 countries. It also noted that, while the EU requires cigarette packs to have a warning that says “smoking kills,” the requirement for IQOS is to print: “This tobacco product damages your health and is addictive.”
As part of its FDA application, PMI must show evidence that there is no “abuse liability” – that non-smokers and former smokers who quit smoking are not becoming new or returned smokers because of IQOS.
If a significant number of non-smokers or former smokers are becoming addicted to smoking because of IQOS, the FDA could use that as grounds for rejecting PMI’s application as a harm-reducer.
PMI has some recent market data from Japan suggesting that the rate of nonsmokers or former smokers, who quit smoking only to get hooked on IQOS, is and will remain low. PMI acknowledged that it does not yet have definitive proof and Fazenda said that more study results would be released in future.
There are also counter-studies, such as a 2014 survey from the Center for Disease Control and Prevention, which found that use of “safer” e-cigarettes by American high school students tripled in 2013-2014 from some 660,000 to 2 million.
It is possible that the FDA may well let PMI roll out its new product in an attempt to reduce the harm to already hooked smokers. This is PMI’s billion dollar gamble. Where the FDA goes on this issue, Israel is likely to follow.
The writer was a guest of PMI at its research facility in Switzerland.