July 16 End of Day
General Discussion of the Two Day Meeting by TPSAC Members
[A Communications Travesty] What are the rules that govern communications among TPSAC members subsequent to the July meeting?
Editors Note: This is the issue that CRE has identified from the onset. TPSAC members are not experts in FACA law, nor should they be. FDA lawyers are calling the shots so as to dominate the TPSAC proceeding by making it difficult for TPSAC members to communicate on a regular basis.
[CRE Reached a Comparable Conclusion in an Earlier Posts on this Meeting] Most serious aspect of menthol is initiation, dependence, cessation and targeting.
Marketing is important but the Committee is here to look at product.
Chemo-sensory impacts are important.
Tobacco companies market tobacco and of course they market to minorities.
The tobacco industry did a great job in educating TPSAC on the sensory impacts of smoking.
TPSAC ought to look at tobacco industry data on chemical sensory issues.
FDA does their job if tobacco sales go down
Menthol has significant impact on how the public smokes if it is measured in total nicotine equivalents.
What happens in the absence of menthol cigarettes?
July 16 Noon
Public Comment Period
ACSH, American Council on Safety and Health, stated that for the purposes of this discussion even if menthol increased the taste of cigarettes, where does the government’s jurisdiction end in terms of regulating the incorporation of product enhancers, such as premium tobacco or refinement of the production process.
Mr. Steir also stated:
“Tobacco companies have provided a vigorous defense against the argument that menthol is an important factor in inducing young people to initiate smoking, or that it impedes cessation. But both sides are equally guilty of cherry picking certain studies to make their case — honing in on technical data analysis that has been inconclusive,”
Minority Group Representatives
A number of representatives of minority groups stated that menthol enhances the taste of cigarettes and should be banned.
Soft Science: Population Effects
Industry emphasized that the data presented by the FDA in a previous TPSAC meeting was incomplete, possibly to the extent that FDA was “cherry-picking” the data.
Industry presented a very substantial number of studies which concluded that menthol had no impact on smoking initiation or cessation.
TPSAC stated that they had a very significant job before them because they had to sort through a host of conflicting studies. TPSAC members said they had a wide range of questions related to industry presentations but insufficient time to address all of them. They were critical of industry reliance on, in their words, studies performed years ago which did not focus on initiation or cessation related to menthol.
l. The “hard” science issues concerning the effect of menthol on cancer and related endpoints is resolved: none of any significance.
2. CRE has identified at least one study identified by FDA, that they argue supports a significant impact of menthol on smoking habits. to be flawed and probably would not pass the requirements of the Data Quality Act.
3. There is a large number of conflicting studies on smoking initiation and cessation related to menthol; CRE’s analysis of these studies is underway.
4. A potential game changer is the statutory requirement that TPSAC review the impacts of a menthol band on contraband, particularly the funding of violent crime organizations.
July 15 End of Day
There is no marketing to children.
No targeting of minorities.
Declining marketing budgets is an industry wide occurrence.
Menthol lowers initiation rates.
A question was raised about how industry knows their advertising does not hit children. Industry response, at point of sale there is no way to control visibility to children but they enforce not selling to minors.
Was interested in data showing that menthol switching consisted primarily of brand switching by menthol smokers.
July 15 Mid-Day
“Hard” Science Issue #3: Biomarkers of Disease
The unique taste of a menthol cigarette is a function of premium tobacco; menthol is a complement to the premium tobacco. You must look at the entire package as a whole not is individual components.
Menthol does not cause adverse physiologic effects.
Menthol cigarettes do not increase toxicity.
There is no difference in biomarkers of exposure, harm and metabolism between menthol and non-menthol cigarettes.
Several of the committee members were skeptical of the robustness of the biomarker data.
The aforementioned surprise or skepticism might have been behind Dr. Connolly’s request that FDA review and report back to the Committee on the industry biomarker data.
Committee members raised a number of questions regarding the PM biomarker study.
Nothing in the third panel suggests a revision of CRE’s earlier conclusion: the “hard” science issues are off the table. The remaining “soft” science issues of initiation and cessation will be discussed tomorrow.
Noon July 15
Hard Science Issue #2: Clinical Effects
(All readers are encourged to review the informatiive comments below received from our readers}
Even this part of the meeting focused, in part, on the “soft” science issues. in that the studies that were discussed had the following conclusions:
— Results show higher menthol levels are not perceived as soothing, but as irritating.
— No difference or reduced consumption for menthol vs. non-menthol smokers.
— Few differences in attribute ratings of menthol vs. non-menthol smokers.
— No difference in less intensive puffing for menthol smokers than for non-menthol smokers.
— The unique taste of menthol cigarettes is a function of premium tobacco; menthol is a complement.
The “hard” science conclusions:
— Menthol does not cause adverse physiologic effects
— Menthol cigarettes do not increase toxicity
— No difference in biomarkers of exposure , harm and metabolism between menthol and non-menthol smokers.
Please note this comment that was posted herein:
“Its hard to believe the epidemiology studies are as one-sided as portrayed by industry. There must be a lot more than 13 studies”.
CRE would appreciate your views on this question.
Another interesting comment:
“It seems like this meeting so far is giving indusrty a great opportunity to present their defense. It’s almost like a trial, where you hear the prosecution, and their case sounds compelling, and then the defense makes it’s case, and it sounds more compelling. Seems like it’s going to be hard to sort it all out. Obviously the issues are not clearcut like some would have us believe. Stay tuned I guess.”
Editors Note Unchallenged, the totality of industry conclusions stated in Panel Discussions 1 and 2 would end debate about the “hard” science issues associated with menthol—they would all be resolved.
TPSAC asked several penetrating questions regarding the industry presentations. A number of the questions would affect Tier 2 considerations; few took direct exception to the primary findings of industry.
However, there was a question by Dr. Hatsukami which addressed industry’s statement that there is no relationship between menthol and dependence. The industry response was that when you consider confounders, there is no discernible difference menthol effect. There were no further questions on this topic.
Dr. Henningfield asked if there were any benefits of menthol. The industry response was that menthol usually retained the current level of consumption or reduced it. Industry also stated a resultant macro benefit was that as a consumer product company they were meeting the demands of their consumers.
Dr. Benowitz asked that when you modify menthol levels what is your objective in doing so? Industry response is that they do not modify menthol levels based upon consumer surveys.
Again there were many questions regarding the “soft” science issues which suggest that the resolution of the menthol issue is going to depend on the “soft” science issues not the “hard” science issues.
The “hard” science issues have been laid to rest. Obviously CRE can not speak for TPSAC, however it is our considered opinion that TPSAC’s primary interest is on the “soft” science issues of initiation and cessation.
July 15 Mid-Morning
The Committee is examining five issues:
Three “hard science” issues—direct impact on health
One marketing issue
On “soft” science issue—initiation and cessation
Hard Science Issue # 1: the use of menthol in cigarettes
(1) The weight of the evidence demonstrates that menthol does not increase the inherent risk of smoking.
(2) Several industry statements commented on the impact menthol has on taste and cooling effects
(3) Another industry statement emphasized that menthol is just one of a wide range of additives to maximize the consumer experience.
TPSAC comments focused more on the “soft” science than the “hard” science in that they focused on industry statements regarding taste and cooling effects. Dr. Samet did a good job in attempting to keep the discussion on “hard” science issues.
TPSAC did not give convincing arguments that menthol produced an increase in risk relative to non-menthol products.
Members of the press should call CRE at 202.265.2383 for additional details.
Our readers may post their comments in the “comments” section below.
Thur July 15 Meeting to begin at 8:30; reports will be filed mid-morning, noon and mid-day.
Wed July 14
Editors Note: As a result of the following items which have been called to CRE’s attention which question the legitmacy of the TPSAC, CRE in its live reports on the TPSAC meeting of July 15 and 16 will break with its tradition of reporting only on factual statements but instead will augment them by reporting on the integrity of the proceeding.
Our readers will note that CRE took no position on statements made by both industry and NGO’s that some of the FDA appointments to TPSAC were riddled with conflicts of interest, but the crescendo of crticism leveled by a range of stakeholders has reached a point that the integrity of the entire TPSAC must be subjected to the same analytical scrutiny as is the underlying data on menthol.
Is FDA Cherry-Picking Data ?
Bloomberg News reports :
“Some of the FDA’s staff testimony in March consisted of “cherry-picking” of scientific research pointing to possibly greater health risks from menthol, Greensboro, North Carolina- based Lorillard said in a 34-page brief submitted to the advisory panel June 29. “The best available science does not support an assertion that menthol in cigarettes impacts public health,” the company said”
Is FDA Squelching Informed Debate?
Please see the comments below which state that the FDA is giving preferential treatment to voting members of the Committee and that panel members should resist this action by the FDA. Is the first statement accurate, if so what is the basis for this action?
Is FDA’s analytical base in support of a ban so weak that it must resort to curtialing information counter to its position? If the alleged crticisim is correct, is not TPSAC a charade?
There appears to be one member of the panel who might be free from the alleged machinations of the long Federal arm, her name is Ms. Karen DeLeeuw. CRE invites her to address this matter.
It also appears that Dr. Wakefield as a specialist in behavioural research should also weigh in on this matter since we assume she has seen a number of instances of abnormal behavior.
Fri July 10
CRE will post the more salient statements made at the forthcoming TPSAC meeting on the homepage of the IPD in real time.
These posts will allow our audience to make comments on the CRE posts during the course of the meeting. In that the IPD is read by federal officials and the press, our readers are encouraged to make comments simply by clicking on the Comments link.
If you have any particular items of interest please identify them by making a post in the comments section of this post.