May 12, 2014
We just published a major review of the scientific literature on e-cigarettes in the journal Circulation. The paper, as well as a "cardiology patient page" on e-cigarettes are available for free on the Circulation website.
Here is the press release UCSF put out about the paper:
E-Cigarettes Expose People to More than ‘Harmless’ Water Vapor and Should be Regulated, UCSF Scientists Find
First Comprehensive Analysis Shows that Industry Health Claims are Unsupported by Data
In a major scientific review of research on e-cigarettes, UC San Francisco scientists found that industry claims about the devices are unsupported by the evidence to date, including claims that e-cigarettes help smokers quit.
The review marks the first comprehensive assessment of peer-reviewed published research into the relatively new phenomenon of electronic cigarettes.
May 11, 2014
I just submitted this public comment to the docket on the FDA deeming rule. The analysis they did this time makes all the same mistakes they did in 2010 when they analyzed the proposed warning label rule.
RE: Economic model used in Regulatory Impact Analysis underestimates benefits by ignoring short term effects of stopping and starting tobacco use
The Regulatory Impact Analysis for the proposed rule bases its assessment of benefits on the old 2004 book, The Price of Smoking, by Sloan, et al (Ref 68). The analysis in this book, while reasonable at the time it was published, is badly out of date because it does not account for the rapid changes in risk of several diseases (most notably heart and lung diseases and well as complications of pregnancy) that happen when people stop or start smoking. Even cancer risks begin to fall much more quickly than reflected in Sloan, et al. Because of the (appropriate) use of time discounting, the FDA's failure to account for these short-term effects leads the RIA to substantially underestimate benefits and so substantially overestimate the break-even point in terms of years of life saved.
May 7, 2014
Philip Morris and the Cigar Association of America have both requested that the FDA extend the current 75 day comment period on the deeming rule for another 75 days (which would make it nearly 6 months long).
The 75 day comment period is already 50% longer than the minumum 50 days required by law.
Despite the generally tepid nature of the draft rule (exemplified by the fact that all the investment analysts are saying, correctly, that the proposed rule is even weaker and more pro-industry than expected), the tobacco interests are saying that they don't have enough time to respond.
That's ridiculous. All they want is delay so they can keep selling their addictive products and work to get an even more sympathetic Congress.
May 7, 2014
There are several examples in the deeming rule of the FDA laying out a good scientific case to do something, then ignoring the evidence they present and saying that they are going to do the opposite thing that the evidence suggests. (More evidence of White House meddling?) A great example of this is the FDA's decision not to have a warning on cigars about reproductive toxicity.
I just submitted the following public comment on this point:
May 7, 2014
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA–2014–N–0189
RE: FDA proposal not to include reproductive warning on cigars
On page 23168 of the Proposed Rule the FDA states: “FDA is not proposing the fifth FTC warning (Tobacco Use Increases The Risk Of Infertility, Stillbirth And Low Birth Weight), because although cigarette smoking has been shown to cause these health effects and cigar smoke is similar,
the Agency is not aware of studies specifically linking cigars to these reproductive effects.”
FDA specifically requested comment on its proposal to require the use of only four of the five current FTC warnings for cigars.
May 4, 2014
I just submitted this public comment on the FDA deeming rule on Regulations.gov:
May 4, 2014
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. Docket No. FDA–2014–N–0189
RE: 2014 Surgeon General Report and Deeming Rule
In reviewing the proposed rule I could not find a single citation to the 2014 Surgeon General's Report, The Health Consequences of Smoking: 50 Years of Progress (available at http://www.surgeongeneral.gov/library/reports/50-years-of-progress/index...). This report contains important information that is directly relevant to the proposed deeming rule, including: