IQOS ignites new debate between tobacco industry, health community
A new battle in the decades-long war between tobacco companies and health advocates recently began when the FDA permitted Philip Morris’ IQOS Tobacco Heating System to go on the U.S. market.
According to Philip Morris’ website, the IQOS Tobacco Heating System consists of a battery pack that lasts about a year and a hollowed-out cylinder. A modified cigarette, called a HeatStick, is inserted into what looks like a hollowed-out cigar at one end, lighted and warmed to about 350°C without ash, combustion, fire and smoke that contains a “significantly reduced level of harmful chemicals,” according to the company. Each HeatStick lasts about 6 minutes or 14 puffs — similar to most of its combustible counterparts — and burns about 600° lower than traditional cigarettes, research suggests.
The company hailed the decision as victory for consumers.
“It’s time to treat [millions of U.S. smokers] like adults and — under the FDA’s careful oversight — enable them to leave cigarettes behind forever, including by switching to scientifically substantiated better alternatives such as the one FDA has now authorized,” Moira Gilchrist, PhD, Philip Morris’ vice president of scientific and public communications, said in a statement.
Some public health advocates said that no matter how it is packaged, tobacco and nicotine is a harmful combination.
“FDA’s decision is as helpful to smokers who want to quit as offering hand sanitizer to the person with obsessive compulsive disorder who needs to wash their hands constantly — it doesn’t fix the problem,” Frank T. Leone, MD, MS, director of comprehensive smoking treatment programs and professor of medicine at the Hospital of the University of Pennsylvania said in an interview.
Though IQOS has been available in parts of Europe and Asia for some time, stateside awareness of the device may be limited. The FDA granted IQOS’ applications through its premarket tobacco production application pathway, which is intended for tobacco products that are “appropriate for public health.”
The agency was also quick to also note that their action “does not mean these products are safe or ‘FDA approved.’ All tobacco products are potentially harmful and addictive,” it said in a statement.
According to FDA’s website, companies seeking that ‘public health’ designation must address a myriad of questions, including: how the health risks of the new product compare to the health risks of other products, how the new product influences chances that current tobacco users will stop using other tobacco products or how never-users and former-users of tobacco products will respond to the new product.
Gregory Conley, president of the American Vaping Association, said Philip Morris met that standard.
“This is a big win for public health and adult smokers who are seeking out satisfying reduced-risk alternatives. Heated tobacco products are not safer than traditional vaping products, but both products are clearly far less hazardous than smoking cigarettes,” he said in a statement.
Research summarized on Healio has suggested inconsistent findings surrounding e-cigarettes among users and never-users.
For instance, a study in JAMA Network Open concluded that youths who used e-cigarettes were at increased risk for starting and using combustible cigarettes, while a study in Drug and Alcohol Dependence suggested the opposite effect.
In addition, data presented at the 2018 American Thoracic Society International Conference suggested e-cigarettes provided no change in total quit attempts, which conflicted with a study in The BMJ that found the devices were positively associated with the success rate of individual quit attempts.
Philip Morris is still waiting for the FDA to rule on its separate modified risk tobacco product applications that would allow the company to market them with claims of reduced exposure or reduced risk.
An FDA committee rejected most of Philip Morris’ reduced risk claims at a hearing in January 2018.
Potential benefits, risks
Representatives from Philip Morris have repeatedly said IQOS is not 100% safe, but does have “significant” benefits.
“IQOS emits toxicants and is not risk-free” but “emits significantly lower levels of toxicants than regular cigarettes. .... Switching to iQOS can significantly reduce the risk of disease compared to regular smoking,” Manuel Peitsch, Philip Morris' chief scientific officer, said in a story broadcast on National Public Radio.
Philip Morris has also claimed in a press release that the availability of IQOS would lead to smokers giving up traditional cigarettes.
However, Michael Siegel, MD, MPH, a professor at Boston University’s School of Public Health who has studied tobacco products for more than 20 years, questioned the accuracy of that claim.
“So far as I know, there have been no studies done in the United States that have looked at whether or not IQOS is better than e-cigarettes at helping someone quit. I’m not sure why they are making that assertion,” he said in an interview.
“If e-cigarettes and vaping didn’t exist, then maybe IQOS could help people quit. But the reality is that we have millions of smokers who have switched to e-cigarettes that are tobacco-free. In that context, it makes it difficult for me to see these products as the step forward some have said IQOS is,” he continued.
As part of its FDA application process, Philip Morris also provided data on various pulmonary and CVD-related measurements among IQOS users, noting that only “significant” changes were observed in patients’ HDL cholesterol levels. The company also found that those who switched to IQOS had an increase of 1.91% of predicted value in FEV1 vs. combustible cigarettes users.
The company’s findings should be viewed with skepticism, researchers told Healio Primary Care.
“We have not had the opportunity to extensively study Philip Morris’ claims and that company has a long history of misleading consumers,” Maciej Lukasz Goniewicz, PhD, of the division of cancer prevention at Roswell Park Comprehensive Cancer in Buffalo, New York.
Goniewicz led one of the few U.S.-based research teams to test IQOS in laboratory settings.
“We found that emissions from the heat-not-burn cigarettes damaged bronchial epithelial cells, and their cytotoxic effect was higher compared with e-cigarettes, but lower compared with combustible tobacco cigarettes. Though heat-not-burn cigarettes had about 10-times-lower amounts of lung cancer causing carcinogens than combustible cigarettes, IQOS had many more carcinogens than e-cigarettes.”
“In addition, the carcinogens contained within the nicotine delivery in the heat-not-burn cigarette was significantly higher than that of e-cigarettes, but significantly lower than that of combustible cigarettes,” he added.
His findings are not the only research that cast doubt on Philip Morris’s claims.
Stanton A. Glantz, PhD, director at the University of California San Francisco’s Center for Tobacco Control Research and Education, wrote in Tobacco Control that there was no “statistically detectable” difference between IQOS and conventional cigarettes for 23 of 24 biomarkers of potential harm among American adult smokers.
Another study by a different group of researchers, also appearing in Tobacco Control, concluded the method Philip Morris used to assess the public health impact of cigarettes and IQOS regarding mortality from lung cancer, ischemic heart disease, stroke and COPD “excluded morbidity and underestimated mortality.”
The FDA has previously pointed out a potential caveat to the company’s data.
“While no deaths, CV disease, COPD, or lung cancer were reported during the clinical studies, these diseases have a long latency and are unlikely to be observed during studies of this type,” FDA documents related to IQOS’ application state.
Cliff Douglas, JD, vice president of tobacco control at the American Cancer Society acknowledged that IQOS research is in its infancy. But he told Healio Primary Care that the “larger context” of IQOS’ inspiration must be remembered: “the conventional, combustible cigarette that produces 7,000 chemicals, at least 70 of which are known to cause cancer, and are by far the leading cause of preventable death from cancer, heart disease and other illnesses. ... Based on current scientific understanding, it is likely that IQOS is worse for health than e-cigarettes.”
Access to minors
The FDA’s authorization of IQOS came with “stringent restrictions” on how the heat-not-burn cigarettes are sold, including that advertising only be targeted to adults, keeping the FDA abreast of its labeling, advertising, marketing plans, and including information and limiting access to the product among youth.
“We’ll be keeping a close watch on the marketplace, including how the company is marketing these products, and will take action as necessary to ensure the continued sale of these products in the U.S. remains appropriate and make certain that the company complies with the agency’s marketing restrictions to prevent youth access and exposure,” Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products, said in a statement.
Philip Morris has said they intend to “minimize any unintended use by never smokers, especially youth.”
The company provided insight on their plans for doing so at the aforementioned FDA hearing in January 2018.
“Potential retail customers would have to show a government ID to confirm they are of legal age. ... We're also looking at doing dedicated branded webpages that will have a very extensive age verification process,” Sarah Knakmuhs, vice president of heated tobacco products at Philip Morris said.
A health advocate said the company’s promises and pledges amount to lip service.
“I liken it to the fox guarding the henhouse,” Harold J. Farber, MD, MSPH, an associate professor of pediatrics within the pulmonary section of Baylor College of Medicine, Texas Children’s Hospital and Texas Children’s Health Plan, said in an interview.
“Think about it: the tobacco industry’s livelihood rests on teenagers and young adults becoming addicted. They may say they will only sell to 18- and 19-year-olds, but teens will see people using IQOS, think it’s cool and with no strict barriers on purchasing, be able to get their hands on it,” he continued.
Siegel said predicting trends among youth poses challenges, but he tended to think IQOS would not reach the prominence that e-cigarettes have in that age group.
“IQOS is made from tobacco, tastes like tobacco and studies have shown youth don’t enjoy that taste. Vaping became popular because of the flavors that eliminate that taste like bubble gum and cotton candy. I don’t see IQOS as being a big addiction risk for teens but you just never know,” he said.
Douglas said in the interview that Philip Morris’s IQOS advertising outside of the U.S. has raised concerns within his organization.
“The company has marketed IQOS in other countries in ways that target young people, including through social media, sponsorships of beach parties and fashion shows, and by presenting the product as a tech gadget,” he said.
Douglas’ comments proved prescient, as less than 2 weeks after the FDA granted the IQOS application, Reuters reported that Phillip Morris had suspended a global social media marketing campaign that featured a woman from Russian claiming to be 25 years old — an age that the company said does not break the law, but violates its marketing standards.
In a follow-up interviews with Douglas and Farber after the Reuters report, both said it was reminiscent of past issues with tobacco advertising.
“Philip Morris and other members of the tobacco industry have a history of crossing the line and targeting kids with products that cause addiction and premature death. In light of their having done so again with IQOS, all eyes will be on their future conduct,” Douglas said in a report.
“The company has been actively promoting their IQOS product to young people internationally — through social media influencers, point of sale advertising, IQOS boutiques, etc. — to make their product seem like a cool, desirable and "must have" purchase,” Farber added. “The industry has a track record of working around restrictions on promotion to young people so that they are technically in compliance with regulations but still achieve their goal. You can put lipstick on a pig, but it is still a pig,” he said.
Because the social marketing campaign was international, it was outside the FDA’s jurisdiction. An FDA official, when asked about the Reuters report by Healio Primary Care, provided more insight into the “stringent restrictions” Philip Morris must abide by as a condition of its application being granted.
According to the FDA, the restrictions stated that the company cannot advertise IQOS on television or radio and will be required to use (and require influencers to use) the available age-restriction controls on social media platforms to restrict youth access to the products’ labeling, advertising, marketing, and promotion appearing in the company’s branded social media accounts and related content. Among other things, the company must also provide quarterly reports that provide ad impressions for several age groups besides minors.
Take-home message for clinicians
Farber said IQOS’ availability in the U.S. underscores the need for primary care physicians to stay up to date on the changing look of tobacco products.
“PCPs need to know that when a patient says ‘cigarette’, they are likely not just referring to our grandparents’ cigarettes. The market is rapidly changing, what is being promoted to us is changing, our patients’ health is constantly changing, so we need to learn all we can about these products,” he said.
Elisa Tong, MD, MA, an associate professor of medicine at the University of California, Davis provided suggestions for PCPs to discuss IQOS with their patients.
“Your patients need to understand that these devices are still tobacco products and that switching tobacco products is not quitting and could lead to dangerous dual use of multiple tobacco products,” she said.
“Ask all your patients about all types of cigarette use, and if there is any kind of such use indicated, encourage use of one of the seven FDA-approved tobacco cessation medications that, combined with counseling which is available through quitlines such as 1-800-QUIT-NOW,” Tong continued.
Leone said PCPs need to follow the proven evidence when trying to help their patients stop smoking.
“Ethically, I am bound by the notion of offering my patients interventions that are safe, proven and effective. Therefore, I would never tell a PCP to recommend IQOS as a smoking cessation device,” he said.
IQOS is expected to be available in the United States by September, according to Philip Morris’ parent company Altria. – by Janel Miller
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Disclosures : Healio Primary Care was unable to determine neither Gilchrist’, Conley’s, nor Peitsch’s relevant financial disclosures prior to publication. Neither Leone, Siegel, Goniewicz, Glantz nor Farber report any relevant financial disclosures. Douglas is employed by the American Cancer Society. Zeller is employed by the FDA. Tong reports serving as project director of CA Quits, a statewide learning collaborative on tobacco treatment funded by the California Department of Public Health.