Cigarette manufacturer Philip Morris International Inc.'s (PM) new smoking device should be killed until the U.S. Food and Drug Administration audits clinical trials, says a special investigation released Wednesday from Reuters.
Philip Morris has spent more than $3 billion on such devices. The one in trials, known as IQOS, is designed to lower the levels of toxins found in regular cigarettes by heating tobacco instead of burning it.
But as the device heads toward approval in 2018, several former employees and contractors have described irregularities in clinical trials that raise red flags. The quality of some of the researchers and sites used for testing were questionable.
The FDA should review its audits "and possibly expand them," David Kessler, FDA commissioner from 1990 to 1997, said.
In a press release issued earlier this year to investors, the company said that 1 million adult smokers had already converted to IQOS and a smoke-free future.
Advanced clinical trials in the spring published in Nicotine & Tobacco Research showed "positive results," the company said.
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