"The agency needs to do more to protect Americans; in particular, we must shape a regulatory framework that reduces their use of combustible cigarettes," the pair wrote. "The agency's new tobacco strategy has two primary parts: reducing the addictiveness of combustible cigarettes while recognizing and clarifying the role that potentially less harmful tobacco products could play in improving public health."
That process shifted into high gear with this week's meeting of the FDA's Tobacco Products Scientific Advisory Committee. There, for the first time, the tobacco giant is being publicly challenged to present evidence that IQOS will reduce risks not just to smokers who switch to the product, but to the country as a whole.
In meetings that end Thursday, the FDA advisory committee's nine voting members, all experts in smoking and its health impacts, are pondering a swirl of effects that the new product could have on the public's health. The panel is considering whether, and by how much, switching to IQOS could reduce the inhaled toxins thought to cause the deaths of roughly 480,000 Americans per year.
Reviewing research conducted by Philip Morris and others, the FDA's staff scientists concluded that, compared to typical cigarette smoke, the vapors generated by the IQOS system contained concentrations of 54 dangerous compounds that were steeply reduced.
But they were far from zero. The results showed that consuming 10 HeatSticks exposes users to levels of 10 compounds -- acetaldehyde, acetamide, acrylamide, ammonia, butyraldehyde, catechol, formaldehyde, mercury, propylene oxide and pyridine -- that are comparable to smoking between one and three cigarettes. Formaldehyde is carcinogenic to humans. Acetaldehyde, acetamide, acrylamide, butyraldehyde, catechol and propylene oxide have been labeled "possibly carcinogenic" to humans.
But in FDA documents prepared for the advisory panel, a further worry emerged: that toasting tobacco may allow the release of some harmful chemical compounds, including pesticides, that igniting does not. In fact, in recent filings to the FDA, Philip Morris reported it had identified between 53 and 62 compounds that were found at higher levels in the exhaled vapor of the HeatSticks than they were in conventional cigarettes. Whether any would be harmful to humans isn't yet known.
And then there is the question that only animal testing, clinical trials and time can answer: Will the documented reductions in exposure to harmful chemical compounds actually translate into lower death rates from cancers, cardiovascular diseases and respiratory disorders?
On this front, the FDA's staff report suggests the jury is still out. In cell cultures, IQOS aerosol was found to harm cells and induce mutations in their DNA. When mice, rats and human tissues were exposed to high concentrations of the vapors released by the HeatSticks, researchers reported signs of precancerous changes in the cells that line the respiratory tract.
In clinical trials, smokers assigned to use the IQOS system showed early physiological changes akin to those seen in quitters. But over time, the FDA staff reported, "substantial changes were not observed."
The panel also is mulling the societal impacts of a "reduced risk" tobacco product. They must ask, for instance, whether offering smokers a less-risky alternative to quitting outright is a good thing. Close to 70 percent of U.S. smokers say they want to kick the habit, but research has shown that few succeed on their first try. How many will lose the resolve to try -- and try again -- to quit completely when they have access to a product that is marketed as less dangerous?
They must anticipate how many who have already quit might be tempted to revert to a tobacco product marketed as less risky, and how many who have never smoked might be drawn in by the same allure.
On all these deliberations, the research that guides them is limited in its scope and scale. The data has had little time to mature -- IQOS hasn't been on the market anywhere for more than a couple of years. And much of the data is drawn from countries, such as Japan, with smoking cultures that are different from the United States'.
Virtually all of that research has also been generated by Philip Morris itself in support of its application to the FDA. Given the company's decades-long history of lies and obfuscation about the dangers of tobacco, few public health advocates are inclined to accept their findings without replication, and a powerful dose of salt.
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