Tobacco Center Faculty Blog

January 13, 2013

Stanton A. Glantz, PhD

There is a long and well-developed literature about the placebo effect where people think a treatment worked when, in fact, it was no better than a sugar pill.  Personal testimonials about the benefits of e-cigarettes do not constitute scientific evidence that they are effective ways to quit smoking.

If and when there are high quality longitudinal studies showing that e-cigarettes as actually used actually help people quit smoking conventional cigarettes, I will modify my opinions on e-cigarettes as cessation aids. As of now, the reality is that such studies simply do not exist.  Until they do the US Federal Trade Commission and, once it takes jurisdiction, the Food and Drug Administration (and other similar authorities in other countries) should prohibit making or promoting such claims by companies selling e-cigarettes.

To avoid contributing to the misinformation on this point, I do not post the testimonials I am sent. 

January 11, 2013

Stanton A. Glantz, PhD

A few days ago Karen Blumenfeld sent me a press release sent out by e-cigarette company RivoCig saying that it would be distributing e-cigs in the swag bags at the Golden Globes and encouraging people to "vape" at the ceremonies. 

I passed this on to the California Attorney General's office, who contacted the Hollywood Foreign Press Association, sponsor of the Golden Globes.  As a result, the Hollywood Foreign Press Association's lawyer sent a cease and desist letter to RivoCig demanding that the company removed all mention of the Golden Globes from its website and press materials. 

RivoCig as complied and the HFPA has certified to the Attorney General that there are no tobacco products or e-cigs in the official goody bags, or that will be distributed by the Assn to attendees.  The AG's office has also asked the HFPA attorneys for confirmation that they will not allow vaping at the Golden Globes.

January 9, 2013

Stanton A. Glantz, PhD

Two colleagues, Ganna Kostygina and Pamela M. Ling, and I have submitted a public comment to the FDA in opposition to RJ Reynolds' citizen's petition for the FDA to change the warning labels on smokeless tobacco products.  

Our bottom line is:

"Altering the text of the warning label to unequivocally state that smokeless tobacco presents substantially lower risks to health than cigarettes neglects the effects of dual tobacco use and the effects of smokeless tobacco use on smoking cessation, and so is fundamentally misleading consumers to underestimate the true risks associated with smokeless tobacco use.

 "For these reasons, the Citizen’s Petition should be denied.

 "In addition, as the FDA deliberates the content of any new smokeless warning labels, it should see that any such new warnings include the information that smokeless tobacco can discourage smokers from quitting tobacco and address the dangers of dual use.  To minimize the possibility of dual use, the FDA should prohibit the promotion of smoked and smokeless products as line extensions of the same brand name, and prohibit the explicit promotion of dual use."

The full comment is available here.

January 9, 2013

Stanton A. Glantz, PhD

The paper is. Hospital Discharge Rates Before and After Implementation of a City-wide Smoking Ban in a Texas City, 2004–2008. Prev Chronic Dis 2012;9:120079. DOI: http://dx.doi.org/10.5888/pcd9.120079 by Head P, Jackson BE, Bae S, Cherry D

January 9, 2013

Stanton A. Glantz, PhD

I just submitted the following comment to the FDA regarding how it evaluates industry claims of "substantial equivalence" to regulations.gov.  The comment identifier is 1jx-830l-kgne.

 

I have reviewed this Guidance Document and was surprised not to see any mention of statistical power or effect size, which are crucial issues in evaluating “negative” studies that are presented to show that some change to a tobacco product does not affect its risk profile.

A key question that underlies all statistical analysis of data is the question of how sensitive a study needs to convincingly accept the null hypothesis of no effect (i.e., substantial equivalence).  In other words, how confident can one be in interpreting a "negative" finding in the sense of not finding a statistically significant difference before one can conclude "equivalence."  This is a particular problem because most statistical hypothesis testing (which gives rise to P values and "statistical significance") implicitly assumes that the investigator wants to find a difference and so is focused on estimating the probability that a reported difference is a change random finding rather than a real effect (i.e., a false positive conclusion).

Pages