July 16 End of Day
General Discussion of the Two Day Meeting by TPSAC Members
TPSAC Views
[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,”
CRE
Testimony
http://thecre.com/pdf/JT_TPSAC_Testimony.pdf
Letter
http://thecre.com/pdf/FDA.TPSAC.Let.pdf
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 Views
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 Views
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.
CRE Views
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
Marketing
Industry Views
There is no marketing to children.
No targeting of minorities.
Declining marketing budgets is an industry wide occurrence.
Menthol lowers initiation rates.
TPSAC Views
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.
CRE Views
None
July 15 Mid-Day
“Hard” Science Issue #3: Biomarkers of Disease
Industry Views
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.
TPSAC Views
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.
CRE Views
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}
Industry Views
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.
Editors Note”
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:
archie
“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.”
TPSAC Views
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.
CRE Views
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
Industry Statements:
(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 Statements:
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.
CRE Conclusion
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?
Editors Note:
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.
What a great resource!
CTP staff keeps TPSAC industry reps in the dark again!
CTP staff is deliberately keeping industry TPSAC reps in the dark. Voting TPSAC reps get briefing materials, industry reps do not. Please note that none of the briefing materials to date could be withheld from industry reps on basis of trade secret information.
First, FDA loads up the committee with “experts” who already declared their position that menthol should be banned.
Now they cut off any informed debate from individuals who might differ from their views?
It appears that TPSAC has been consumed by the FDA.
Why do not some of the academics on the panel who have their reputations at stake contest such actions by the FDA?
There was mention of a “white paper” either presented to the committee or being prepared by the committee. Does anyone know what this is? Is it an FDA paper? Does the committee have it? It does not appear to be among the meeting materials.
I am viewing the meeting via webcast. Am i right that there are three FDA officials sitting at the table with the committee? If so, that does not seem appropriate.
It is interesting that industry claims they only do taste testing with adults over 21. If so, how would they know whether there is a preference for menthol among underage smokers?
The FDA mentioned that a Subcommittee of the full Committee will write the Menthol Report. How are such members selected and will FDA staff be at the table writing the report?
The point about menthol being more irritating than non-menthol seems consistent with my experience. I smoked some during college, and I tried quite a few different brands, menthol and non-menthol. I found I did not like menthol, whether it was high or low, because it felt irritating/unpleasant compared to non-menthol. But, generally, I would often smoke whatever was available, although avoiding menthol as much as possible. This is of course just one person’s impression. (BTW, I stopped smoking a long time ago.)
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.
Its hard to believe the epidemiology studies are as one-sided as portrayed by industry. There must be a lot more than 13 studies.
Did Dr. Hatsukami ask the industry experts about the effect of a ban on menthol early this morning? If I heard correctly she asked but was ruled down by Chair Samet as not asking a “clarifying question”.
Seems clear to me where she is headed.
One committee member asked whether menthol had any benefits, and he seemed to be suggesting the viewpoint that if there is no health benefit from menthol, it should be eliminated. The implications of such a point of view for other food or drug additives seem extreme. For me, it was a bit surprising that the industry reps did not point to some of the evidence, such as that which came up later in their presentation of biomarker studies, that suggests menthol reduces smoking and dependence. But apparently the operative phrase today is “not statistically significant,” and the industry position that non-menthol and menthol cigarettes are virtually the same except in subjective taste.
This question was followed (I believe) by another question that seemed to be related and also seemed to go to the heart of the matter: What would happen if we took away menthol cigarettes. To this, one industry rep simply indicated that they thought there would be unintended adverse consequences, and that they would be getting into that subject in the future. This could get interesting.
Tracker, that was a good question about a subcommittee starting to draft the committee’s report. I think this raises issues under the transparency provisions of the Federal Advisory Committee Act. Now that you have raised the issue, I am curious and will probably look into it.
Wow, we have another committee member seeming to suggest that menthol cigarettes should not be allowed unless they confer a public health benefit. The member also did not seem to have a clear idea of the “mission” or charge for the committee.
The companies really seem to have thrown down the gauntlet with many strong statements and conclusions, while the committee seems to be nibbling around the edges of the data and issues looking for some opening. But I’m sure that won’t be the end of it.
The quality of the webcast is excellent. Both video and sound are clear, and it is exremely useful to be able to see the live video and the slides side by side.
Unfortunately the webcast is not working at this time due to technical difficulties. The contractor is working on it. The audio only is available, and the sound quality is not good.
Does anyone know what’s happened to the webcast? It was very good yesterday, but it’s been down all day today. After yesterday I was counting on it for today.
The free webcast is back up.
This does not reflect well on CTP’s and the Committee’s competence. Probably a lot of people were relying on the webcast. Maybe they will at least record it and put it up for later viewing or get the transcript done much quicker than usual.
Again, like yesterday, we had a Committee member apparently attempting to insert policy considerations into the meeting by quoting a definition of public health policy and asking whether menthol cigarettes actually promote health among African Americans.
I think one of the most important points made by the companies this morning was that the survey studies that are often cited for showing that there is a higher rate of initiation among underage smokers for menthol cigarettes are based on simply asking whether they had smoked a menthol cigarette within the last 30 days. This is a pretty useless question with regard to adolescents, since they probably smoke a variety of cigarettes, depending on what they can bum from friends or “expropriate” from their parents or older siblings. The subjects most likely also smoked non-menthol cigarettes within the last 30 days also.
Another important point was whether underage smokers who try either menthol or non-menthol then go on to be consistent smokers, or whether they were just experimenting. Industry asserted that 3 out of 4 adolescents never go on to become consistent smokers, so that would definitely seem to skew the initiation survey data with regard to longer-term public health impacts.
no video and the audio really sucks; the audio is even worse for the public presentations
The webcast is up again — both video and good audio
There’s still some annoying underlay audio
One public presenter (Tosi?) brought up that the statute requires the committee to consider whether banning menthol would lead to a black market like with Prohition. He said it is in the statute, but did not give a citation. Can someone direct me to the section of the statute? Also, I don’t recall it being in any charge or questions FDA gave to the committee? Did I miss something?
The presenter for Hawaian/Asian communities compares menthol to sprinkles on a donut. Does he really think that if someone who loves donuts could not get donuts with sprinkles they would not grab a donut without sprinkes?
I checked the statute with regard to the “black market” issue raised a little while ago in one of the public presentations. The statute is complex, but it’s definitely there. It’s in section 907(e)(1), where it states: “In its review, the [TPSAC] shall address the considerations listed in subsections (a)(3)(B) and (b).” Subsection (b)(2) states that the Secretary shall consider information on “countervailing effects” of a regulation, “such as the creation of a significant demand for contraband or other tobqcco products ….”
The current public presenter’s emphasis on the taste issue(“a little bit of sugar makes the poison go down easier”) brings to mind a possible legal issue: Does the exclusion of menthol from the flavors provision of tha statute mean that the Secretary could not ban menthol solely or primarily on the basis of taste preferences.
How is a scientific committee going to address the “black market” issue? I doubt there is much published scientific or other hard data they could use.
Dr. Connolly seems to want to help the world– global implications of the Committee’s action. Might make the survey population much larger — and the statutory charge of the TPSAC!
I get the feeling the committee is floundering and that some members have already made up their minds.
There has been a lot of interest in how Lorillard increased its market share with Newport. But what about Marlboro Menthol, which appears to have been making similar gains more recently?
The committee is spending a lot of time on trying to figure out what additional data to request from the companies, rather than discussing the existing studies and published data. This seems to indicate they find the existing data equivocal and are hoping to find something new that will help resolve the issue one way or the other.
The committee is interested in price promotions increasing menthol cigarette consumption. But that doesn’t seem unique to menthol. Presumably, price promotion could increase consumption of non-menthol cigarettes as well.
Samet is obviously having a difficult time getting the committee to focus on the central issues. It seems it would be useful to him to have a detailed charge to refer to. There have been a number of mentions of a charge, but where is it?
Based on today’s meeting, I think you could be right. It looks like the committee is so disoriented they might leave most of the work to FDA or a couple of their members instead of working independently as a full advisory committee.
“Follow the science wherever it leads and the rest will fall into place.”
FDA Commish, Margaret Hamburg, July 15 2010
There was a lot of discussion about the distinction between “chemo-sensory perception” and “taste.” I seriously doubt that the average consumer would recognize the distinction in choosing something. It’s simply a matter of sensation.
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