June 17, 2019
FDA’s April 2019 decision authorizing Philip Morris to market its IQOS heated tobacco product in the United States set a new low bar for establishing that a new tobacco product protects the public health.
Lauren Lempert and I have read the FDA’s 122 page decision document and prepared a detailed analysis of the FDA’s decision (the “Technical Project Lead Review”) for the IQOS PMTA. This analysis raises serious questions over how the FDA assessed the risks and public health impact of IQOS that raise serious questions about how the FDA will handle premarket applications in the future.
Before marketing any new tobacco product in the United States, a manufacturer must submit a premarket tobacco application (PMTA) to FDA. In May 2017, Philip Morris submitted a PMTA seeking an order permitting it to sell its IQOS heated tobacco product in the U.S.
June 17, 2019
On May 15, 2019, a federal court ruled that the FDA was abrogating its responsibility and set aside FDA’s August 2017 Guidance that gave e-cigarette companies until 2022 (and companies selling other newly-deemed combustible products until 2021) to file premarket applications (PMTAs) to sell their products. Another problem with the FDA’s current policy is that it would allow products to remain on the market while the FDA considered their applications, regardless of how long FDA spent thinking about it.
The court gave the health groups and the FDA two weeks to file their suggested remedies.
June 16, 2019
Chris Millett’s research group recently published “Smoke-free legislation and neonatal and infant mortality in Brazil: longitudinal quasi-experimental study” in Tobacco Control Consistent with research conducted in the US and Europe, they found substantial drops in neonatal and infant mortality following implementation of smokefree laws. These are large and immediate benefits that should be promoted when advocating for such laws.
In addition to saving a lot of lives, this saves a lot of money, since the avoided costs are saved immediately. Conversely, continuing to force pregnant women and babies to be exposed to secondhand smoke means more deaths.
Here is the abstract:
Objective To examine the associations of partial and comprehensive smoke-free legislation with neonatal and infant mortality in Brazil using a quasi-experimental study design.
Design Monthly longitudinal (panel) ecological study from January 2000 to December 2016.
Setting All Brazilian municipalities (n=5565).
Participants Infant populations.
June 16, 2019
Colorado Public Radio ran an important story last week on the implications of the fact that PMI’s IQOS can already communicate back to Philip Morris and Juul is talking about activating the same capability to its e-cigs. The title says it all: As E-Cigarettes Get More Sophisticated, Questions Mount About Privacy, Potential To Maximize Addiction.
These capabilities are being presented as benign ways to give users helpful information like when to clean the IQOS or buy more heetsticks (the tobacco plugs IQOS heats), but they will also enable PMI and Juul (and any other company that adopts similar technology) the ability to track the detailed puffing behavior of users to “tune” the device so that it maximizes consumption (i.e., sales of heetsticks and pods) to maximize sales and profits.
Everyone knows that you recharge the Juul by putting it on a stand that plugs into a USB port. That takes two electric contacts (positive and negative). When I asked what the other two contacts on the bottom of the Juul are, I was told “data.”
This is a very important issue that should draw the attention of national media (NPR could pick the story up from CPR) and privacy advocates well beyond the usual public health crowd.
June 16, 2019
Here is the job description:
The (Sr.) Scientific Affairs Advisor, US Government is principal scientist role who will be providing key insight and opinion for policy and regulation, research analysis and in-depth scientific contextualization to the US Government Affairs and Regulatory teams. This position is responsible for scientific advisory to internal organizations for comprehensive, accurate scientific and clinical information within regulatory guidelines of region/country. These organizations would include: medical and clinical affairs, communications, government affairs, commercial operations, and management. This will include meeting with government officials and strategic third-party scientific partners in DC and across the US.
Duties include (among other things):
- Meeting with government officials and strategic third-party scientific partners in DC and across the US.
- Ability to manage in-depth confident conversations/debates with scientific, medical, business and government professionals.
- Work closely with regulatory, medical and clinical affairs, region presidents and global scientific affairs to disseminate and maintain integrity of corporate scientific narrative.