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The iQOS device, is a Heat not Burn (HnB) smokeless alternative to combustible cigarettes and works by heating tobacco leaves known as Heets or HeatSticks. These refills which look like short cigarettes, must be inserted into the device and are heated up once iQOS is turned on. They are sold by Philip Morris under the Marlboro brand (depending on the country) for approximately the same price as their combustible counterparts.

Around this time last year, PMI had announced that it submitted a Modified Risk Tobacco Product (MRTP) application with the FDA’s Center for Tobacco Products for iQOS. The device has had unparallel success in Japan and Korea, and naturally the PMI hopes that the US market will be just as successful. Hence, the company has carried out extensive research in order to prove the relative safety of the product.

Former employees report questionable quality levels

A former employee who questioned the quality of some of the researchers and sites contracted to carry out research, ended up being excluded from meetings.
However, PMI’s attempts to appear as having harm reduction at heart may take a set back. An article published by Reuters earlier this week makes shocking (perhaps not so surprising) claims, that former PMI employees who were involved in clinical trials for iQOS, have reported a number of irregularities in the research process.  

Former coordinator for PMI’s trials and co-author of the company’s protocol used to run it’s studies globally, Tamara Koval, said that at some point she questioned the quality of some of the researchers and sites contracted to carry out this research. Voicing her concerns resulted in her being excluded from meetings.

“Reuters also found irregularities during interviews with some of the principal investigators contracted to conduct the trials for the company. One principal investigator said he knew nothing about tobacco. Philip Morris had to jettison the experiment that investigator performed after it emerged he hadn’t followed a basic procedure for obtaining informed consent from participants during clinical trials,” read the article.

“A second investigator submitted urine samples that exceeded what a human being is capable of, according to two former company employees, and then initially refused to acknowledge there was a problem. A third said he doesn’t hold such company-sponsored clinical trials in high regard, describing them as “dirty” because their purpose is more commercial than scientific,” added the Reuters article.

PMI’s clinical trials called “dirty”

Reuters proceeded by sending its findings to Philip Morris, who in response released a statement saying “all studies were conducted by suitably qualified and trained Principal Investigators,” adding “Our policies encourage speaking up about suspected violations of law or our policies and we do not tolerate retaliation against those who speak up.”

However the above findings were not all, Reuters held interviews with a number of the principal investigators who were involved in the clinical trials and reviewed PMI’s publicly available study reports. This investigation “identified shortcomings in the training and professionalism of some of the lead investigators, as well as their knowledge of the study results.”

“Taken as a whole, it’s clear they do not have the sophistication to carry out adequate and well-controlled clinical trials.” David Kessler, Former FDA Commissioner

PMI “lacks the sophistication” to carry out such research

Following this, the news agency proceeded to present their findings to a group of tobacco research and policy experts including a former head of the FDA and two former scientific advisers for the agency. The experts agreed that these findings raise concerns.  

“Taken as a whole, it’s clear they do not have the sophistication to carry out adequate and well-controlled clinical trials,” said David Kessler, the FDA’s commissioner from 1990 to 1997, referring to the company. “I am not inferring any malicious intent here, just that they lack sophistication, because this is not their bread and butter.”

Read Further: Reuters

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