FDA names Tobacco Scientific Advisory Committee

[Bill Godshall]

The FDA just announced 9 members of its tobacco Products Scientific Advisory Committee, which shouldn't have any influence on e-cigarettes until the FDA decideds to reclassify and regulate e-cigarettes as tobacco products.



http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/ucm180906.htm

Roster of the tobacco Products Scientific Advisory Committee

Applying for Membership on FDA Advisory Committees1

As part of the food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees. (More info2)​

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Current Number of Vacancies 3​

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Note, one or more vacancies may be in the nomination process or a final appointment may have been made.​

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Chair

Jonathan M. Samet, M.D., M.S.3Expertise: Internal Medicine, Pulmonary, Epidemiology, Tobacco Control, Public Health
Term: 02/16/10 - 1/31/14
Professor and Flora L. Thornton Chair, Department of Preventive Medicine
Keck School of Medicine
University of Southern California, Los Angeles
Norris Comprehensive Cancer Center
1441 Eastlake Avenue, Room 4436, MS 44
Los Angeles, California 90089
Acting Executive Secretary

Cristi L. Stark, M.S.
Center for Tobacco Products
Food and Drug Administration
9200 Corporate Blvd., Rm 110H
Rockville, MD 20850-3229
Phone: 240.276.3992
Fax: 240.276.3904
Email: Cristi.Stark@fda.hhs.gov

Members

Neal L. Benowitz, M.D.4Expertise: Nicotine, Substance Abuse, Clinical Pharmacology, Toxicology
Term: 02/17/10 - 1/31/13
Professor
Chief, Division of Clinical Pharmacology
Departments of Medicine and Biopharmaceutical Sciences
Schools of Medicine and Pharmacy
University of California, San Francisco
Box 1220
San Francisco, California 94143–1220

Mark Stuart Clanton, M.D., M.P.H.5
Expertise: Oncology, Pediatrics
Term: 02/17/10 -1/31/14
Chief Medical Officer
American Cancer Society
High Plains Division
2433-A Ridgepoint Drive
Austin, Texas 78754

Gregory Niles Connolly, D.M.D., M.P.H.6Expertise: Public Health, Tobacco Control, Smokeless Tobacco
Term: 02/16/10 - 1/31/12
Acting Director, Division of Public Health Practice
Harvard School of Public Health
Landmark Bldg, Floor 3E,
401 Park Drive
Boston, Massachusetts 02215

** Karen L. DeLeeuw, M.S.W.7Expertise: Family Health, Public Health, State & Local Government
Term: 02/16/10 - 1/31/13
Director, Center for Healthy Living and Chronic Disease Prevention
Colorado Department of Public Health and Environment
4300 Cherry Creek Drive South
Denver, Colorado 80246

Dorothy K. Hatsukami, Ph.D.8Expertise: Clinical Psychology, Smokeless Tobacco, Tobacco Cessation and Harm Reduction
Term: 02/17/10 - 1/31/13
Forster Family Professor in Cancer Prevention and Professor of Psychiatry
Tobacco Use Research Center
University of Minnesota
717 Delaware St. SE
Minneapolis, Minnesota 55414

* Patricia Nez Henderson, M.P.H., M.D.9Expertise: Public Health, Epidemiology
Term: 02/16/10 - 1/31/14
Vice President
Black Hills Center for American Indian Health
701 St. Joseph Street, Suite 204
Rapid City, South Dakota 57701

Jack E. Henningfield, Ph.D.10
Expertise: Addiction Medicine, Pharmacology,
Health Policy
Term: 02/16/10 - 1/31/12
Vice President, Research and Health Policy
Pinney Associates
3 Bethesda Metro Center, Suite 1400
Bethesda, Maryland 20814

Melanie Wakefield, Ph.D.11Expertise: Psychology, Advertising & Marketing, Behavioural Research
Term: 02/16/10 - 1/31/14
Director, Centre for Behavioural Research in Cancer
The Cancer Council Victoria
1 Rathdowne Street
Carlton
Victoria, Australia 3053

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As described in the charter of the committee, the membership includes:
* Representative of the General Public
** Employee of a state or local government or of the Federal Government.
# Representative of the tobacco manufacturing industry, non-voting
## Representative for the interest of small business tobacco manufacturing industry, non-voting
### Representative of the interests of tobacco growers, non-voting

 

[Mac]

well the FDA has their dream team now! Maybe that will cheer me when I show up for work one day to be greeted by federal agents protecting those precious BP and BT tax revenues... =(

 

[Bill Godshall]

It should be noted that Jonathan Samet, chair of the TPSAC, participated in the FDA's July 22nd press conference where e-cigarettes were trashed.
FDA and Public Health Experts Warn About Electronic Cigarettes

Greg Connolly, another committee appointed, has opposed smokeless tobacco products as harm reduction alternatives to cigarettes for more than two decades, advocated snus bans in the EU, Australia and elsewhere more than a decade ago, testified to the US Senate HELP Cmt in 2007 that the FDA should "make cigarettes tast like lard", and spoke against e-cigarettes in October at
BUniverse - Is There Such a Thing as a Safe(r) Cigarette? Tobacco Regulation and the FDA

Another committee appointee, Mark Clanton, is Medical Director for the American Cancer Society, which had advocated a ban on e-cigarettes, and has long opposed smokeless tobacco products as harm reduction alternatives to cigarettes.

Jack Henningfield, who works for GlaxoSmithKline funded Pinney Associates, has opposed smokeless tobacco products as harm reduction alternatives for cigarettes.

 

[CES]

i was feeling a lot less concerned before you posted the mini bios

 

[cliff5550]

Kinda like:
The good news is the FDA names 9 members of its Tobacco Products Scientific Advisory Committee.
The bad news is the FDA names 9 members of its Tobacco Products Scientific Advisory Committee.

 

[rothenbj]

Looks like they have a team and they have the agenda. If the FDA doesn't get them, the dream team will!

 

[TropicalBob]

Looks like a deck stacked against cigarette alternatives.

Neal Benowitz is no friend of us either, as I recall. Memory could be faulty on him .. but I'd much rather have seen a Brad Rodu or other supporter of harm reduction on that panel.

 

[Vocalek]

I am very disappointed at the way Jack Henningfield turned out. If anyone should know the devastating effects that nicotine abstinence can have on cognitive abilities, he should. He once put a number of people into a hospital situation where their abstinence could be monitored (enforced?) and noted that they suffered cognitive deficits that were not resolved until they resumed smoking two weeks later. That experiment was over 20 years ago.

He somehow convinced himself that gradual reduction of niotine would completely eliminate these effects.

For me, for TB, and for millions like us, it doesn't work.

 

[Vocalek]

Oh, did I forget to mention that at its annual conference this past weekend, the Society for Research on Nicotine and Tobacco voted to exclude employees of tobacco companies from membership in the future?

The only folks on the above list whose names I did not find in the 2010 SNRT program were the FDA employee Christi Stark, the ACS guy Mark Clanton, Karen DeLeeuw, and Melanie Wakefield.

So 5 out of 9 belong to an organization that wants to put the tobacco industry out of business. I characterize their view of tobacco harm reduction as "Pharma or Nada".

Somehow, that doesn't seem to fit with what their job is supposed to be on this Advisory Committee.

 

[Our House]

Sort of like AA counselors being in charge of regulating alcoholic beverages?

 

[Vocalek]

More like founding members of the WCTU regulating the sale of alcoholic beverages.

 

[Madame Psychosis]

I think the only remotely 'good' news in there is, as Bill Godshall pointed out, these selections are not relevant unless and until the FDA classifies PVs as tobacco products.

But out of curiosity, I did a publication search on the chairman, Jonathan Samet. If interested, go to PubMed and type in "samet jm[Author]" in the search field to see abstracts or at least titles, but there's a substantial number to wade through, and I don't see anything really surprising in the tone of the tobacco articles. (Much of the rest of his work focuses on air pollutants.)
Random comments --
On the one hand, he seems to consider the possibility of long-term NRT:

Am J Public Health. 2010 Feb;100(2):341-8. Epub 2009 Dec 17.
Estimating the risks and benefits of nicotine replacement therapy for smoking cessation in the United States.
Apelberg BJ, Onicescu G, Avila-Tang E, Samet JM.

OBJECTIVES: To compare potential population-wide benefits and risks, we examined the potential impact of increased nicotine replacement therapy (NRT) use for smoking cessation on future US mortality. METHODS: We developed a simulation model incorporating a Monte Carlo uncertainty analysis, with data from the 2005 National Health Interview Survey and Cancer Prevention Study II. We estimated the number of avoided premature deaths from smoking attributable to increased NRT use, before and after incorporating assumptions about NRT harm. RESULTS: We estimate that a gradual increase in the proportion of NRT-aided quit attempts to 100% by 2025 would lead to 40,000 (95% credible interval=31,000, 50,000) premature deaths avoided over a 20-year period. Most avoided deaths would be attributable to lung cancer and cardiovascular disease. After we incorporated assumptions about potential risk from long-term NRT, the estimate of avoided premature deaths from all causes declined to 32 000. CONCLUSIONS: Even after we assumed some harm from long-term NRT use, the benefits from increased cessation success far outweigh the risks. However, the projected reduction in premature mortality still reflects a small portion of the tobacco-related deaths expected over a 20-year period.

...but no doubt it must be pharma NRT. Nicotrol inhaler anyone?

But any hope from that idea was extinguished with a little more reading back in time, such as...

Am J Public Health. 2001 Nov;91(11):1742-4.
Turning science into junk: the tobacco industry and passive smoking.
Samet JM, Burke TA.
Comment in:
* Am J Public Health. 2002 Jun;92(6):891.
Comment on:
* Am J Public Health. 2001 Nov;91(11):1749-57.

In this issue, Glantz and Ong offer a powerful analysis of the tobacco industry's attempt to discredit the scientific evidence on passive smoking, particularly the industry's use of the label "junk science." Environmental epidemiologic studies in other arenas have also been targets for the "junk science" label. Lessons for researchers involved in high-stakes issues in the public policy arena include a need for awareness of competing interests, for transparency concerning funding, and for adherence to rigorous quality assurance and peer review practices. The goal of "sound science" seems an admirable one; it should not, however, be used to dismiss available but uncertain evidence in order to delay action.

No wonder he was part of the FDA press conference.

 

[kristin]

"...to recruit qualified experts with minimal conflicts of interest..."

FAIL.

 

[boxhead]

looked quickly, did not see a when and where for this Committee`s meets.
will the minutes be avalible to the public?
dang it i think my first 510 atty just died...awman, i just topped it off too...

 

[JerryRM]

FAIL.

Kristin, I don't think the FDA really cares what the people think!!

 

[mpetva]

Michael Siegel
GlaxoSmithKline Given a Seat on FDA Tobacco Products Scientific Advisory Committee

The Rest of the Story: Tobacco News Analysis and Commentary

The Rest Of The Story!

 

[Vicks Vap-oh-Yeah]

<big snip>

<big snip> The goal of "sound science" seems an admirable one; it should not, however, be used to dismiss available but uncertain evidence in order to delay action.

No wonder he was part of the FDA press conference.

I just have to point out that the above quote could be turned around quite readily in the pursuit of freedom to vape........

available but uncertain evidence................ is that not EXACTLY what our anecdotal evidence could be classified as???? All the 'I feel better, I breathe better's' that 90%ish of the vaping population state quite vehemently.

 

[mpetva]

Wall Street Journal

FDA Tobacco Panel Includes Members With Quit-Smoking Ties - WSJ.com


Partial Quote:

The selections raise questions about whether the members would have a conflict of interest on topics such as whether to approve a low-carcinogen smokeless tobacco product as a safer alternative to cigarettes. Such products compete for smokers' dollars against smoking-cessation aids such as the Nicorette gum marketed in the U.S. by GlaxoSmithKline.

 

[TropicalBob]

The Campaign For Tobacco-Free Kids, a Washington-based anti-smoking organization, praised the FDA's choice of committee members.

This line from the Journal tells us all we need to know about the impartiality of the group. If CTFK thinks it's great for them, then it's dead meat for us.

And I don't share any rosy "this might be good for us" scenario. This is total lose-lose. If e-cigs somehow are concluded to be tobacco products, then this group of bought-and-paid-for Super Nannies sets the rules. You think Big Pharma allies and/or Big Tobacco debtors will view an alternative to cigarettes positively? Think again. All prospects for consideration by the committee -- unless they come from Big Pharma -- are doomed to rejection. Forget health merits. Follow the money.

Ah, but if e-cigs are a drug product, then they face years of clinical trial hurdles while being banned in the interim. Plus, the studies will be "flawed" and unacceptable. Wait and see on that one.

 

[JerryRM]

This line from the Journal tells us all we need to know about the impartiality of the group. If CTFK thinks it's great for them, then it's dead meat for us.

And I don't share any rosy "this might be good for us" scenario. This is total lose-lose. If e-cigs somehow are concluded to be tobacco products, then this group of bought-and-paid-for Super Nannies sets the rules. You think Big Pharma allies and/or Big Tobacco debtors will view an alternative to cigarettes positively? Think again. All prospects for consideration by the committee -- unless they come from Big Pharma -- are doomed to rejection. Forget health merits. Follow the money.

Ah, but if e-cigs are a drug product, then they face years of clinical trial hurdles while being banned in the interim. Plus, the studies will be "flawed" and unacceptable. Wait and see on that one.

So, either way the court case goes, we will lose !!!

Get ready to either quit altogether or go underground.

I really hope that I am wrong, someone please tell me that I am wrong !!!