Editors Note: Hopefully the very talented staff of NCI can shed additional light on the questions which follow. Recognizing, however, that they have a wide range of commitments, CRE, as a safeguard, is initiating its own in-depth review of this subject. This action is warranted because a number of press articles reported the following conclusions but without any caveats.
In a January 10, 2011 presentation to TPSAC, a representative of NCI concluded:
o “Behavioral intention is associated with actual behavior”
o ” 39% of menthol smokers say they would quit all tobacco use if menthol cigarettes were no longer sold”
Regarding the statement that behavioral intention is strongly associated with actual behavior, most people are well-intended in their planned objectives and goals but often fail to accomplish them.
To this end, CRE has reviewed several menthol studies in which reported statistics and conclusions on cessation rates cause us to have concerns about factors not addressed in the NCI presentation—in particular relapse.
For instance, Dr. Okuyemi in his work titled, “Does Menthol Attenuate the Effect of Buprophion Among African American Smokers?” February 2003, he concluded that non-menthol smokers had higher cessation rates than menthol smokers, at the end of a six week period. The difference was by nearly fifteen percentage points. However, Dr. Okuyemi did not highlight that by the end of the sixth month, the cessation rates dropped by 7% for menthol smokers and 15% for non-menthol smokers.
An examination of the record in total reveals an insignificant difference between the two smoking groups, but more importantly, with respect to the NCI briefing, highlights the observation that the relapse factor needs to be considered.
Question # 1
Even in the best case scenario, in which all intended quitters indeed quit smoking at the onset, what research/modeling has been done to estimate the percentage of former smokers who will experience a relapse ?
The NCI survey results include two non-declarative categories: “None of the Above” and “Don’t Know/Refused.” For the total sample size, these two categories combined for a total of over 17%. The issue of contraband was widely discussed in the TPSAC meeting. The 17% comprised from these two categories should cause concern as to whether this percentage could be a pre-indicator of behavioral intent to seek out contraband menthol cigarettes.
Does NCI believe other choices could be provided to the responder, such as “switch to alcohol, nicotine gum, nicotine patch, etc.” in an effort to draw out the responder and gain better insight into specific planned actions?
TPSAC members were interested in knowing from the FDA if source data had been requested for these various studies. CRE has initiated requests for supporting data in other instances, but to no avail.
When will NCI release the aforementioned data to the public?
See Hartman Presentation below.Hartman TPSAC