April 27, 2020
My colleagues and I have submitted this public comment to FDA in response for its request for information on what not to allow in e-cigarettes in light of the outbreak of serious lung disease (EVALI) last year.
While there are some obvious things to exclude (like vitamin E acetate), we caution the FDA not to create a de facto “safe harbor” list of elements for “acceptable” e-cigarettes. The Regulations.gov tracking number is 1k4-9gd3-yb2m. A PDF of the comment is here.
FDA should prohibit additives and design elements in e-cigarettes known to increase the risk of severe lung injury, but the burden remains with manufacturers to demonstrate that their products are appropriate for the protection of the public health, notwithstanding the fact that their products exclude the prohibited ingredients and designs
Lauren K. Lempert, JD, MPH; Gideon St.Helen, PhD; Carolyn Calfee, MD, MAS;
Jeffrey Gotts, MD, PhD; Michael A. Matthay MD; Matthew L. Springer, PhD;
Stanton A. Glantz, PhD
UCSF TCORS
Docket No. FDA-2020-N-0597
April 24, 2020
April 21, 2020
Dharma Bhatta, Eric Crosbie, Stella Bialous and I just published “Defending comprehensive tobacco control policy implementation in Nepal from tobacco industry interference (2011-2018)” in Nicotine and Tobacco Research. This paper describes how health advocates in Nepal, with assistance from international organizations, successfully defended its comprehensive tobacco control law from continuing industry attacks after it was passed.
There has been a lot of research on how laws get passed, but less on what happens during the implementation period. This case shows that even in a low and middle income country it is possible to defend and enforce strong legislation.
April 20, 2020
Heated tobacco products like Philip Morris’ IQOS are being promoted as safer than cigarettes in the context of the COVID-19 pandemic.
In contrast, PMI’s own data that was submitted to the FDA shows that, in terms of effects on lungs, including inflammation and depressed immune function, IQOS is not distinguishable from a cigarette.
My colleagues at UCSF published “Assessment of industry data on pulmonary and immunosuppressive effects of IQOS” last year that provides the details.
Here is the abstract:
Introduction Heated tobacco products are being touted as novel reduced-harm tobacco products by tobacco companies. In the USA, Philip Morris International submitted a modified risk tobacco product (MRTP) application to the US Food and Drug Administration in 2016 in which it purports that its heated tobacco product, I-Quit-Ordinary-Smoking (IQOS), is associated with reduced harm compared with conventional cigarettes.
Methods We reviewed Philip Morris International’s MRTP application to assess the pulmonary and immune toxicities associated with IQOS use in both animal and human studies.
April 17, 2020
Working in collaboration with colleagues at the San Francisco Department of Public Health and the San Francisco Tobacco Free Coalition, we just published “Compliance with San Francisco’s flavoured tobacco sales prohibition” in Tobacco Control. The paper details the educational campaign and engagement with local retailers followed by formal enforcement that has led to 80% compliance on direct inspection.
April 16, 2020
There are a lot of reasons to expect that smoking would make COVID-19 worse. Kade Patanavanich and I have completed a meta-analysis of 12 papers that present evidence on disease progression among people who have been diagnosed with COVID, 10 from China, 1 from Korea, and 1 from the USA. We found that the odds of disease progression were more than doubled.
These papers all have limitations, most notably the fact that they are almost certainly missing a lot of smokers in their patient histories. This limitation will lead to the risk being underestimated.
The paper reporting these results is now under peer review. Consistent with the urgency of the situation and the general policies of a growing number of journals that pre-prints of papers be made available during the peer review process, we have posted our manuscript to the medRxiv preprint server here.
Here is the abstract:
Objective: To determine the association between smoking and progression of COVID-19. Design: A meta-analysis of 12 published papers.