FDA, NIH create 14 centers to do tobacco research (AP)

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Luisa

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If something is dubious add "Science" to it to give it credence. Regulation is not science. At best it is (social) engineering, though I suppose it could be based on findings in science, perhaps pseudo-science. I prefer to think of sciences as the traditional, hard sciences and not the wannabe so-called modern, social-based sciences that tend towards providing observations for administrators to cherry-pick and use to form policy.

The only way to benefit from "Regulatory Science" is for you, or some who you may be allied with to find a way to play it. Obviously, some in academia and government have done so. There are also some interests in the e-cig community playing to benefit along these lines... Be wary...
I don"t understand the comment about the e-cig community. How could we benefit from "studies" conducted by the people listed on the government Grant recipients?
 

Cool_Breeze

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I don"t understand the comment about the e-cig community. How could we benefit from "studies" conducted by the people listed on the government Grant recipients?

"We" might be thought of as individuals and organizations rather than a unified mass of simply 'consumers.' Studies might indicate a need for matters such as quality control / clean facilities for production of liquidware. There is at least one ecig community organization supporting such matters and many liquidware producers are ascribing to those notions. Additionally, the organization has stated that it will attempt to get their standards made into law and thus apply to all liquidware producers.

Information derived from studies could put other community organizations in the position of possible compromise that might be dubious for the community, but perhaps provide longer term security for operators of those organizations. Those perhaps in position to broker community interests, as suggested in the above paragraph may end up be middle-persons and benefit from both sides of the issues. Organizations have been known to morph a bit in their prime directive. Positions for individuals in quasi-governmental or privatized administration are all about.

Individuals who can find middle positions and benefit from restrictive regulations may find their positions shifting a bit. If community interests represent products, equipment or services that end up being required by regulations. Well...do I really need to go on?

I think we may see that there are a lot of angles to be played in a regulated environment and there can be a lot of middle-people positions.

If you had a resource (clean room suits?) that were being suggested by studies to be a benefit in the production of liquidware, would you consider becoming a supplier to the industry? If not you, others. Could that possibility influence their outlook when communications regarding possible regulatory issues are being considered between the community leadership and regulators?

Individual vapers may not have the ear of the regulators, but some organizations do communicate with them. Some regulations may not be bad news for everyone in the community depending on where there interests lay.

"Politics makes for strange bedfellows." Be wary of just who may be brokering the interests of the community.
 
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Petrodus

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When the FDA announces their demon regulations ... Someone somewhere will post
"What we need is a White House petition"
1-FaintingTHUD.gif
 

Bill Godshall

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Tobacco Centers of Regulatory Science (TCORS)

tobacco Centers of Regulatory Science (TCORS)
As part of an on-going interagency partnership, FDA and NIH are awarding $53 million in fiscal year 2013 to establish 14 tobacco Centers of Regulatory Science (TCORS) for tobacco-related research.

As a first-of-its-kind regulatory science tobacco program, TCORS is designed to generate research to inform the regulation of tobacco products to protect public health and train the next generation of tobacco regulatory scientists.

Investing in Tobacco Regulatory Science
Over the course of a five-year period, FDA and NIH are awarding a total of more than $273 million to the TCORS programs. In turn, these grants will provide scientific evidence in the following seven tobacco-related research areas:

Diversity of tobacco products;
Reducing addiction;
Reducing toxicity and carcinogenicity
Adverse health consequences;
Communications;
Marketing of tobacco products;
and Economics and policies.
This research will help inform and assess FDA’s prior, ongoing, and potential future regulatory activities. TCORS investigators will also have the flexibility and capacity to respond to FDA’s research needs as issues are raised in today’s rapidly evolving tobacco marketplace.

The TCORS Grantees
TCORS proposals were selected for funding based on scientific and technical merit as determined by NIH scientific peer review, availability of funds and relevance of the proposed projects to the TCORS program priorities. The following organizations and investigators received grants:

Organization Title Investigator(s)
American Heart Association American Heart Association Tobacco Regulation and Addiction Center (A-TRAC) Aruni Bhatnagar, Rose Marie Robertson
Georgia State University The Science of Decision-Making: Connecting People and Policy (GSU TCORS) Michael Erikson
Ohio State University OSU Center of Excellence in Regulatory Tobacco Science (OSU-CERTS) Peter Shields, Mary Ellen Wewers
Pennsylvania State University Pennsylvania State University Tobacco Center of Regulatory Science (PSU TCORS) Joshua Muscat, Jonathan Foulds
University of California San Francisco Improved Models to Inform Tobacco Product Regulation (UCSF TCORS) Stanton Glantz
University of Pennsylvania Tobacco Product Messaging in a Complex Communication Environment (UPenn TCORS) Robert Hornik, Caryn Lerman
University of North Carolina Effective Communication on Tobacco Product Risk and FDA Authority (Center for Regulatory Research on Tobacco Communication) Kurt Ribisl
University of North Carolina The Impact of Tobacco Exposure on the Lungs Innate Defense System (UNC TCORS) Robert Tarran
University of Maryland Rapid Response Characterization of New and Manipulated Tobacco Products Pamela Clark
University of Southern California USC Tobacco Center of Regulatory Science (TCORS) for Vulnerable Populations May Ann Pentz, Jonathan Samet
University of Texas Tobacco Center of Regulatory Science on Youth and Young Adults Cheryl Perry
University of Vermont Vermont Center on Tobacco Regulatory Science Stephen Higgins
Virginia Commonwealth University Center for the Study of Tobacco Products Thomas Eissenberg
Yale University Yale Tobacco Center of Regulatory Science Suchitra Krishnan-Sarin, Stephanie O’Malley


Significant updates on the TCORS projects will be posted on this webpage, as well as on the Tobacco Regulatory Science Program (TRSP)’s TCORS webpage.



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Resources for You

Press Release: FDA and NIH create first-of-kind Tobacco Centers of Regulatory Science
NIH Office of Disease Prevention: Tobacco Centers of Regulatory Science (TCORS)
 

AgentAnia

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Since before yesterday, I was blissfully unaware that the discipline of "regulatory science" even existed, I had to do some research. Sorry for this long post, but want to share what I found (what good is knowledge without someone to share it with! :)):

Regulatory Science appears to be the brainchild of the FDA. (The correct name should probably be "regulatory science for FDA-regulated products.") Read Defining Regulatory Science - Building a National Framework for the Establishment of Regulatory Science for Drug Development - NCBI Bookshelf

Did you know you can actually earn a masters degree in regulatory science? John Hopkins
(Master of Science in Regulatory Science | AAP | JHU) and the Univ. of Maryland School of Pharmacy (Masters in Regulatory Science) both offer degree programs.

Univ. of Maryland (a recipient of one of the TCORS grant, btw) tells you:

Further information about regulatory science at the University of Maryland is available at the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), an FDA-sponsored center that promotes education and exchange between the University of Maryland and the FDA in regulatory science.

The Burroughs Wellcome Fund offers grants in this program: (http://www.bwfund.org/innovation-regulatory-science-awards):

Innovation in Regulatory Science Awards

BWF’s Innovation in Regulatory Science Awards provide up to $500,000 over five years to academic investigators who are addressing research questions that will lead to innovation in regulatory science, with ultimate translation of those results into improving the regulatory process. These awards are intended to provide support for academic researchers developing new methodologies or innovative approaches in regulatory science that will ultimately inform the regulatory decisions the Food and Drug Administration (FDA) and others make. This would necessarily draw upon the talents of individuals trained in mathematics, computer science, applied physics, medicine, engineering, toxicology, epidemiology, biostatistics, and systems pharmacology, to name a few.

Awards for this program consist of a two-stage process. Preproposals will be accepted through Monday, November 18, 2013. From those preproposals, selected applicants will be invited to submit full applications by 4:00 p.m. Eastern Time on April 1, 2014. BWF anticipates announcing at least five (5) full research grants in FY2014.

This all appears to be very recent... I, for one, am left with the impression that the FDA, admitting they can't do their own work, had to create a whole new branch of, er, science and a whole population of, er, scientists, to do their work for them. Or it could simply be that they're afraid to go it alone and want some [FDA-sponsored] "science" to shore up their "regulations." :trying to shake head, roll eyes, and shrug shoulders at same time:

Word for today: Boondoggle: work or activity that is wasteful or pointless but gives the appearance of having value.
 

Bill Godshall

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1. The American Heart Association is part of drug industry funded CTFK/ACS/AHA/ALA that urged FDA to ban e-cigs in 2009, falsely claimed e-cigs were target marketed to youth, has campaigned to ban e-cig use in workplaces, has otherwise demonized e-cigs, and has been urging FDA to impose the "deeming" and other counterproductive regulations for c-cigs.

2. Georgia State's Michael Eriksen was head of the CDC's Office of Smoking and Health during the Clinton Administration, and Eriksen is coathor of The Tobacco Atlas, which repeatedly claims that "tobacco use" (not cigarette smoking) is the leading cause of disease and death. Eriksen is fully aware that smokefree e-cigs and smokeless tobacco are far less hazardous alternatives for smokers, but he promotes abstinence-only no-tobacco-use policies. His funding for The Science of Decision-Making: Connecting People and Policy is likely to promote nanny state control and abstinence-only policies at the expense of truthful risk information and individual autonomy.

3. Ohio State's Peter Shields (who used to be at Georgetown) is a researcher and FDA regulation advocate who views e-cigs and other smokefree THR alternatives products as unproven but potential Modified Risk Tobacco Products, and that manufacturers shouldn't be allowed to make any truthful health claims about smokefree alternatives unless/until FDA first approves it as a MRTP.

4. Penn State's Jonathan Foulds exposed (in 2002) that snus helped many Swedish males quit smoking, but Foulds simultaneously urged Congress to enact the FSPTCA (which banned companies from saying smokeless tobacco is less hazardous than cigarettes, and which required even larger misleading warnings on smokeless packages and ads "This product is not a safe alternative to cigarettes," "This product may cause mouth cancer," "This product may cause gum disease and tooth loss." Foulds published a survey of e-cig users at the 2011 Philly Vape Vest, but it recommended using FDA approved drugs (until more research is done on e-cigarette), and Foulds recently testified to FDA touting the benefits of FDA approved drugs for treating "tobacco dependence."

5. UCSF's Stan Glantz was amazingly awarded the money to study Improved Models to Inform Tobacco Product Regulation Several years ago, Glantz published a junk science model claiming that telling smokers snus is less hazardous than cigarettes would increase smoking instead of decrease smoking, and would harm public health. Glantz has also intentionally misrepresented the scientific and empirical evidence on e-cigarettes in an attempt to ban the products and their use.

6. Univ of Pennsylvania's Robert Hornik and Caryn Lerman are unknown to me.

7. Univ. of North Carolina's Kurt Ribisl is on FDA's TPSAC and is rather objective and honest about tobacco harm reduction products. Two weeks ago, Ribisl was quoted in the AP story saying the CDC's survey results "don't prove that e-cigarettes are a gateway to smoking cigarettes". http://www.ktiv.com/story/23350405/study-childrens-use-of-e-cigarettes-increasing But I don't expect Ribisl to advocate THR products and policies via his funding for Effective Communication on Tobacco Product Risk and FDA Authority

8. Univ of North Carolina's Robert Tarran is unknown to me.

9. Univ of Maryland's Pam Clark has been a long time tobacco control advocate (who promoted policies to reduce tobacco sales to youth along with me two decades ago), but during past decade she advocated the FSPTCA and unwarranted tobacco product regulations. Don't know her views on e-cigs, but her funding for Rapid Response Characterization of New and Manipulated Tobacco Products indicates that she'll be studying and demonizing most/all new smokefree alternatives.

10. USC's Jonathan Samet has been chair of FDA's TPSAC since its inception, and has basically promoted the FDA's agenda while appearing to be sitting on the fence.

11. Univ of Texas' Cheryl Perry is not a friend of THR (but she hasn't been an active opponent either), and her funding for Tobacco Center of Regulatory Science on Youth and Young Adults indicates that she'll be perpetuating the lies that e-cigs are "highly addictive", are "gateways to cigarettes", "appeal to youth and young adults" and are "being marketed to youth and young adults".

12. Univ of Vermont's Stephen Higgins is unfamiliar to me, but if he's affiliated with John Hughes, he may be promoting NRT products as the best way to quit smoking.

13. Virginia Commonwealth's Tom Eissenberg did a study giveing first time users an e-cig without proper instruction, took blood samples and then falsely claimed (several weeks after Judge Leon issued his ruling against FDA in Jan 2010) that e-cigarettes emit no nicotine and are fraudulent products that FDA should ban. After many e-cig consumers on ECF criticized and challenge Eissenberg, he did another study finding that e-cigs can emit lots of nicotine, but he maintained that e-cigs emit no nicotine for the next year until he published the latter study. Eissenberg is also on the FDA's TPSAC, and has basically echoed FDA policies on tobacco regs.

14. I'm not familiar with the folks at Yale (Suchitra Krishnan-Sarin and Stephanie O’Malley)
 
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Petrodus

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Good god... so they basically just funded a Multi-Million Doller Propoganda campaign... and dressed it up as scientific "Research", conducted by 3rd parties.

This is the story the Media needs to hear.
The media won't do anything ... It's science.
The FDA has that base covered also.
:(

I have to admit ... Their battle plan is BRILLIANT
This lets the FDA off the hook.
Reminds me of drug commercials with all the disclaimers
which basically says ... Don't sue us ... Sue your doctor !!
 

Steve803

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Good god... so they basically just funded a Multi-Million Doller Propoganda campaign... and dressed it up as scientific "Research", conducted by 3rd parties.

This is the story the Media needs to hear.

So true, but which one will report it as a bad thing? We are little pee-on's compared to the forces against us. A real david and Goliath story how we can prevail as david did.


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Petrodus

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In what is the largest grant in Georgia State University history, the university’s School of Public Health and its partners will receive $19 million over five years from the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) to establish one of 14 Tobacco Centers of Regulatory Science (TCORS).
Our tax dollars at work.
If you don't like it ... Go ahead and throw a fit
then make a note in your diary and move on.
Nothing we can do about.

Oh, by the way ...
PLEASE, no suggestions we need to contact our Congress people.
They ain't going to do anything !!!!!!
 

Uncle Willie

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On several threads over the last few months, I've said

Since the FDA loss of the Smoking Everywhere / NJOY case a few years back, they have been carefully and methodically putting the ducks in order so next time, the Court will be more favorable

This FDA, NIH create 14 centers to do tobacco research (AP) info should not be a surprise ..
 

AgentAnia

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Good god... so they basically just funded a Multi-Million Doller Propoganda campaign... and dressed it up as scientific "Research", conducted by 3rd parties....

Not only that, but they also basically created the "science" and the "research centers"! Academia: the fourth branch of government.
 
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