The Immediate FDA and NCI Studies on Menthol: A Step Forward or Puffery? ( An Extension of the Press Release)

Editors  Note:  Puffery as a legal term refers to promotional statements and claims that express subjective rather than objective views, such that no reasonable person would take them literally. Puffery serves to “puff up” an exaggerated image of what is being described and is especially featured in testimonials .

Yesterday, November 24,  Medical News Today  published an article with the title “Menthol Cigarette Smokers Find It Much Harder To Give Up”.

Was the aforementioned conclusion based on recent clinical trials of menthol?  No, the article was written based upon  a Supplement to the December 2010 edition of  Addiction.

Were  the analyses contained in the Supplement based upon new clincal trials?  Based upon a preliminary  review it appears that studies in the Supplement  are in  large part  based upon a review of existing clinical trials most, if not all,  of which are the basis  for menthol studies identified by FDA at the onset of the TPSAC  review.

Medical News states: 

“The  Supplement has data from 11 recent studies on smoking cessation rates among  regular menthol cigarette users and factors that may influence them to smoke menthols.”

 “Kola Okuyemi, MD, MPH, senior editor of the Supplement, said:

“These manuscripts, along with those in the prior literature, show that menthol cigarette smoking disproportionately impacts populations at risk of initiating smoking, young people, and tobacco-related health disparities. These papers add to the body of evidence that informs future research and policy directions regarding mentholated cigarettes.” The findings support the statement made to the FDA by Gardiner and Clark that “Given the overwhelming disease and death caused by smoking, menthol has no redeeming value other than it makes the poison go down more easily

A question that comes to mind is whether the 11 studies  published in the Supplement  are the same 11 studies alluded to by Dr. Hersey in his recent testimony to TPSAC  stating that the FDA sponsored studies   might be available before Thanksgiving.?  It is not clear that this could be the case because  Dr. Okuyemi was in charge of the  studies contained in the supplement–not Dr. Hersey.

In  any event  in that the 11 menthol studies are a Supplement   in  Addiction, does this mean a decision to include them was made very recently which prevented their  inclusion in the most recent issue?  Was there a rush to  publication so as to claim the  articles were peer reviewed  and therefore be availalble for consideration by TPSAC under its very demanding schedule?   Since these studies  are funded by a federal agency is their publication in Addiction a ploy to evade compliance with the Data Quality Act ?  More specifically   for studies that  are funded by a federal agency on a pending , high profile subject,  any resultant dissemination by the agency would rquire compliance with the DQA.

Federal law precludes FDA from using the studies in the Supplement until which time FDA demonstrates they are DQA compliant.

CRE does not pretend to have answers to these questions, perhaps our readers do; in such an instance please provide your responses below.

The  editor of the Supplement” is Dr. Okuyemi.

On August 13 of this year, CRE wrote the following note to Dr. Okuyemi:

 Professor Okuyemi:

A review of one of your studies is presented at and .We would appreciate your comments.


Jim Tozzi

Did Dr. Okuyemi respond to CRE?   No.

What did CRE conclude in its review of Dr. Okuyemi’s articles?

 CRE pointed out that the initial study was not designed to study the impacts of menthol on smoking initiation/cessation but instead, in this  instance to determine whether “Menthol attenuate(s) the effect of bupropion among African American Smokers”.

Was the subsequent study titled: Relationship between menthol cigarettes and smoking cessation among African American Light smokers” based upon a new clinical trial?

No, it used the data in the first study. The author’s state:

“Data were derived from a clinical trial that assessed the efficacy of 2 mg nicotine gum (versus placebo) and counseling (motivational interviewing counseling versus Health Education) for smoking cessation among African American light smokers (smoked 10  or less cigarettes per day). “

 CRE stated in no uncertain terms that presence of bupropion made it difficult to assess the effects of menthol. In essence bupropion “gummed” up the works.e

Very early in the TPSAC  evaluation of menthol CRE concluded that the works of  Dr. Hersey  and Dr. Okuyemi were going  to be  given serious consideration by those members of TPSAC  who supported a menthol ban based upon policy not scientific grounds since their respective studies were  far from conclusive.

On the other hand  the authors of one of the Commentaries  definitely exploit the use of  puffery  as a basis for establishing policy;  however since TPSAC is the Tobacco Products Scientific Advisory Committee,  often emphasized  by the TPSAC chair,  we expect scientific arguments to prevail.

 Select Excerpts from the Supplement

The Supplement consists of one Editorial, three Commentaries and eleven Research Reports.

The objectivity of the articles differ substantially;  one of the Commentaries could be classified as puffery and elements of the Editorial are on the edge.  CRE has not reviewed the Research Reports in detail, but CRE has reviewed  the most significant initiation/cessation studies identified by FDA.

CRE concludes that   the Editorial and Commentaries are merely hearsay and have no place for consideration in a scientific proceeding such as TPSAC.

Based upon CRE’s initial analysis it appears that virtually all of the research reports are a re-review of existing clinical studies. However there are several conclusions of note:

The finding that the longer the delay of smoking initiation, the more likely an individual smoked menthol cigarettes, does not support the notion that menthol promotes early smoking initiation.”

After controlling for sex, age and race, the mean number of cigarettes smoked per day by current smokers is significantly lower for menthol smokers when compared to non-menthol  smokers (odds ratio = 0.99; 95%)”

”After controlling for the covariates in each multivariate model, the differences between menthol and  non-menthol smokers were no longer statistically  significant, for smokers consuming fewer than five or six to 10 cigarettes per day” (Editors Note: time to first cigarette)

The findings that menthol smokers in the U.S. tend to start smoking later than smokers of other types of cigarettes are suggestive only and require further study“.

Among African Americans  those who currently smoked mentholated cigarettes were more likely be seriously considering quitting in the next six months than were non-menthol smokers, after adjusting for sociodemographic factors. African Americans  and Hispanics/Latinos  who smoked mentholated cigarettes were also significantly more likely to have a positive estimation of successfully quitting in the next six months compared to non-menthol smokers.”  (Editors Note: the odd ratios were removed from the text; consult the article for these data.)

The prominence given to the Editorial and the  Commentaries relative to the Research Reports detracts from the overall use of the Supplement in a scientific proceeding.

Implications for Federal Regulatory Policy

1.      The FDA identified a number of clinical trials dealing with menthol and smoking initiation/cessation—all of which have been reviewed by a number of stakeholders. What standing should re-interpretations of existing data bases  conducted  by either FDA or NCI  without public comment or peer review have in the deliberations of  a federal advisory panel?

2.      CRE reviewed a number of menthol related smoking initiation/cessation studies identified by FDA.  Why should FDA introduce a re-hash of existing data bases performed by Dr. Hersey  and his 11 accolytes and  possibly the work of Dr. Okuyemi and his colleagues  in the Supplement into the record for review by  TPSAC  and not promote  a similar consideration of the analyses performed by CRE?




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