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Public comment submitting Reuters story on PMI irregulatities in IQOS clinical studies to PMI MRTP docket

Lauren Lempert submitted this comment to FDA on December 20...Reuters published a special report on December 20, 2017 identifying several irregularities in Philip Morris' IQOS research. The kind of industry behavior documented in this report is questionab
Center for Tobacco Control Research and Education (UCSF)
added Dec 22, 2017 02:40
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Letter to FDA TPSAC urging them to delay action on IQOS until the record is closed and they can consider public comments

As someone who has served and does serve on committees similar to TPSAC, I do not see how the schedule that the FDA has established for TPSAC’s consideration of this application can permit a responsible assessment of the applications and associated publi
Center for Tobacco Control Research and Education (UCSF)
added Dec 22, 2017 02:39
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GLANTZ: More evidence that NRT without counseling does not work

This is, of course, something that the tobacco industry has known for a long time, ever since shortly after NRT was introduced.... It also points to the folly of the FDA adopting the tobacco industry’s “harm reduction” approach of simply seeking alternati
Center for Tobacco Control Research and Education (UCSF)
added Dec 22, 2017 02:32
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Does Seeking e-Cigarette Information Lead to Vaping? Evidence from a National Longitudinal Survey of Youth and Young Adults [FREE FULL TEXT]

this study ... highlights the potential effects of regulating e-cigarette marketing information and correcting misinformation about vaping behavior available to young information seekers. Insofar as the FDA wishes to reduce initiation of use, it may need
Health Communication
added Dec 22, 2017 02:19
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The Philip Morris Files PART 3: Clinical Complications: Scientists describe problems in Philip Morris e-cigarette experiments

With a decision expected next year, former employees and contractors have described to Reuters a number of irregularities involving clinical trials that underpin the tobacco giant’s application to the agency. By heating tobacco instead of burning it, the
Reuters
added Dec 21, 2017 16:25
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The Philip Morris Files / The secrets of the world’s biggest tobacco company

Part 1: Treaty Blitz... is using its vast resources against efforts to reduce smoking... Part 2: Marlboro Country...marketing cigarettes in India... Part 3: Clinical Complications....FDA for its iQOS...Part 4: Humming Along....lobbying health officials a
Reuters
added Dec 21, 2017 16:05
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Philip Morris' search for a cigarette no more harmful than a cup of coffee

But four scientists and researchers who worked for the company on the iQOS program told Reuters that while Philip Morris was able to prove the lower amounts of exposure to harmful substances, that doesn’t necessarily mean that using the device is less li
Reuters
added Dec 20, 2017 22:49
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Special Report: Scientists describe problems in Philip Morris e-cigarette experiments

Tamara Koval, who worked at the company...was a co-author of the company’s protocol used to run the studies globally. When she highlighted an irregularity in one of the studies, Koval said, Philip Morris excluded her from meetings.
Reuters
added Dec 20, 2017 22:46
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Reynolds enters FDA modified-risk tobacco gauntlet with Camel Snus styles

Monday, six styles of Camel Snus became the first Reynolds American Inc. tobacco products to enter the Food and Drug Administration review process for gaining modified-risk status. Reynolds submitted modified-risk tobacco product applications April 3.
Winston-Salem (NC) Journal
added Dec 20, 2017 22:12
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The tobacco paradox: Combustible cigarettes kill millions a year. Can Big Tobacco save them?

the world’s biggest multinational tobacco companies seem poised to save many consumers in future, kill millions of them in the meantime and, through multibillion-dollar mergers, become even more powerful. Put that in your pipe and smoke it.
The Economist
added Dec 20, 2017 15:32
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