“Soft” Science Dies Hard

“Soft” scientific studies dealing with menthol, those focused on initiation/cessation, have been reviewed in detail by CRE, see http://www.thecre.com/scur/

The Center for Regulatory Effectiveness, CRE,  does not arbitrarily dismiss the “soft” science studies;  to the contrary, in a number of instances they highlight areas of possible concern. However, very few of the “soft science studies are definitive.

In repeated statements to the FDA Advisory Committee, TPSAC, CRE has stated that the “hard” science studies, those based upon the  toxicology of specific disease endpoints  clearly demonstrate that there is no reason for concern; on the other hand the “soft” science studies fail to meet the mandatory standards set forth in the Data Quality Act.

Consequently, the game changer in the menthol issue could be contraband; a statutory required factor to be considered by TPSAC in making its final recommendation.

In a last minute attempt to make “soft” science studies determinative, federal employee advocates of a menthol ban have resorted to  a “Hail Mary” pass– in American football, a “Hail Mary pass” refers to any very long forward pass made in desperation with only a small chance of success”.

We understand one “Hail Mary” pass, but two?

The FDA is about to release eleven studies dealing with initiation/cessation; this is a defensive  action in that the FDA released the results of the studies to TPSAC before the studies themselves were made available.

In a like manner, federal employee advocates of a menthol ban  have also orchestrated a rush to publication of a litany of initiation/cessation studies by demanding that a Supplement be published in the house organ publication called Addiction, only the second time this has occurred in the history of the publication.

CRE has reviewed one such study in the Supplement to Addiction:

 “Nicotine dependence and quitting behaviors among menthol and non-menthol smokers with similar consumptive patterns

By: Pebbles Fagan, Eric T. Moolchan, Alton Hart, Jr., Allison Rose, Deirdre Lawrence, Vicki L. Shavers, & James Todd Gibson

The CRE review of this study is attached. Upon reading the CRE review, we are confident our readers will conclude that the study is a “Hail Mary” pass.

Attached Files:

1 comment. Leave a Reply

  1. Joe Mulholland

    I too did not think much of the Fagan et al.
    piece, but disagree with CRE’s critique of it. The problem I see with the CRE analysis is that it focuses on a minor aspect of the report, while ignoring its key finding that menthol use is NOT linked to making quitting more difficult. In Fagan’s own words at p. 67:

    These data do not support the hypothesis that menthol smokers experience greater quitting difficulty. Our results are similar to other studies that showed no differences in quit attempts among light menthol and non-menthol smokers [63], quit attempts or duration of quit attempts [64] or 7-day smoking abstinence following treatment [66]. ……
    Findings from additional analyses did not show differences in smoking abstinence at 1, 3 and 6 months between menthol and non-menthol smokers at different levels of consumption (data not shown). *******************************
    To me this is the key takaway from the study, even if the authors choose not to highlight it in the policy section. The CRE critique will unfortunately allow Fagan et al. to muddle the issue by making the following responses:

    1. “Since the data was not directly available to the public, CRE was not able to independently check the statistical findings reported in the subject report.” But, as CRE acknowledged in another section of its critique, the data could have been obtained. True, some work would have been involved in setting up the database and running the
    various statistical tests, but this is normal for articles in academic journals.

    2. CRE calculates different quit attempt Odds Ratios than those reported by Fagan et al. : CRE is mixing apples and oranges here. The Fagan et al. estimate is derived from a multivariate regression equation and is limited to smokers in the 6-10 CPD class. In contrast, the CRE estimate is based on the univariate results reported in Table 1 and apply to smokers in all CPD classes.

    In my view, the key problem with Fagan et al. is not their inability to calculate Odds Ratios, but rather their focus on calculating them for a largely irrelevant subset of smoking behavior: quit attempts for an arbitrary CPD category (6-10). More important are the Odds Ratios for all smokers who successfully quit. Here there appears to be no menthol effect.

Leave a Reply

Please Answer: *