FDA Statement from Mitch Zeller - Four TPSAC members resign or terms terminated

[RCHagy74]

Statement from Mitch Zeller

'On July 21, 2014, Judge Richard Leon of the United States District Court for the District of Columbia issued a ruling that requires the FDA to reconstitute the tobacco Products Scientific Advisory Committee (TPSAC). The ruling also bars the FDA from using TPSAC’s 2011 Menthol Report. Judge Leon issued his ruling in a 2011 lawsuit that alleged in part that certain members of TPSAC had conflicts of interest that violated ethics law. FDA disagrees with the decision, but Judge Leon’s order is currently in effect and we must comply.
For membership on any advisory committee with the FDA, potential candidates are asked to provide detailed information concerning such matters as financial holdings, employment and research grants, and contracts in order to permit evaluation of possible sources of conflict of interest (COI). All original and current TPSAC members successfully met the FDA’s rigorous requirements upon selection. However, Judge Leon’s ruling further expands the FDA’s COI criteria.
As a result of the expanded COI criteria outlined in Judge Leon’s ruling, each voting TPSAC member was rescreened and four members – Chairman Jonathan Samet, Claudia Barone, Joanna Cohen, and Suchitra Krishnan-Sarin – have resigned or their terms on TPSAC have been terminated. This is a loss for the FDA and for public health. Under other circumstances, there would be strong reasons for the agency to consider a waiver or authorization that would allow these individuals to continue their valuable service. However, in light of Judge Leon’s ruling, we do not believe we are able to exercise our discretion to consider this option at this time.
All of us at the agency have appreciated the leadership, insight and expertise of Drs. Samet, Barone, Cohen and Krishnan-Sarin. We extend our sincerest gratitude for their work on the TPSAC.
At the same time, FDA would like to welcome COPYRIGHTDMCA Fagan, Gary A. Giovino, and Thomas E. Novotny as new members of TPSAC. All three of these new members have specific scientific expertise that fits the anticipated needs of the committee, and all three members meet the requirements for membership in accordance with Judge Leon’s ruling and the expanded COI criteria. FDA plans to work expeditiously to fill the remaining vacancy, and all future TPSAC meetings will continue as planned.'

Now we just have to dig deep into the replacements histories... yay.


RCH

A response -

http://rodutobaccotruth.blogspot.com/2015/03/conflicts-of-interest-exposed-fda.html

I like the comic...

 

[Lessifer]

Statement from Mitch Zeller

On July 21, 2014, Judge Richard Leon of the United States District Court for the District of Columbia issued a ruling that requires the FDA to reconstitute the Tobacco Products Scientific Advisory Committee (TPSAC). The ruling also bars the FDA from using TPSAC’s 2011 Menthol Report. Judge Leon issued his ruling in a 2011 lawsuit that alleged in part that certain members of TPSAC had conflicts of interest that violated ethics law. FDA disagrees with the decision, but Judge Leon’s order is currently in effect and we must comply.
For membership on any advisory committee with the FDA, potential candidates are asked to provide detailed information concerning such matters as financial holdings, employment and research grants, and contracts in order to permit evaluation of possible sources of conflict of interest (COI). All original and current TPSAC members successfully met the FDA’s rigorous requirements upon selection. However, Judge Leon’s ruling further expands the FDA’s COI criteria.
As a result of the expanded COI criteria outlined in Judge Leon’s ruling, each voting TPSAC member was rescreened and four members – Chairman Jonathan Samet, Claudia Barone, Joanna Cohen, and Suchitra Krishnan-Sarin – have resigned or their terms on TPSAC have been terminated. This is a loss for the FDA and for public health. Under other circumstances, there would be strong reasons for the agency to consider a waiver or authorization that would allow these individuals to continue their valuable service. However, in light of Judge Leon’s ruling, we do not believe we are able to exercise our discretion to consider this option at this time.
All of us at the agency have appreciated the leadership, insight and expertise of Drs. Samet, Barone, Cohen and Krishnan-Sarin. We extend our sincerest gratitude for their work on the TPSAC.
At the same time, FDA would like to welcome COPYRIGHTDMCA Fagan, Gary A. Giovino, and Thomas E. Novotny as new members of TPSAC. All three of these new members have specific scientific expertise that fits the anticipated needs of the committee, and all three members meet the requirements for membership in accordance with Judge Leon’s ruling and the expanded COI criteria. FDA plans to work expeditiously to fill the remaining vacancy, and all future TPSAC meetings will continue as planned.

Now we just have to dig deep into the replacements histories... yay.


RCH

So they are finally replacing four people after a ruling made them ineligible, four years ago?

 

[RCHagy74]

So they are finally replacing four people after a ruling made them ineligible, four years ago?

The way I read it also... here for me is the main point:

'FDA disagrees with the decision, but Judge Leon’s order is currently in effect and we must comply.'

With everything that I have seen and read about anything government for the last 25 years that I have paid attention, is this:
If they disagree with a law or ruling/judgement, they will drag their feet, make excuses, form committees, have an investigation, sue, get sued and anything else possible, then they will comply...

maybe.

 

[CarolT]

Samet is truly the rottenest of the rotten, but my joy at seeing him gone is tempered with regret that it was for the wrong reason. It should have been because his flagrant scientific fraud in the Surgeon General reports, etc., made him unsuitable to occupy any federal position other than a cell in a penitentiary.

 

[Kent C]

"If they disagree with a law or ruling/judgement, they will drag their feet, make excuses, form committees, have an investigation, sue, get sued and anything else possible..."

And if citizens would do that with FDA regulations, they would be jailed and fined.

 

[RCHagy74]

And if citizens would do that with FDA regulations, they would be jailed and fined.

Only because a respectful minority stand up for their rights. Far to many others are frightened, and far more could care less.

If some incumbent elected official (Federal, State, Local. Sheriff, Judge or Rep), any incumbent is up for election... vote them out.
Next election, vote out that incumbent.
Rinse and repeat for the next twenty to twenty-five years and maybe, hopefully the politicians will learn to fear us.

For money and fear are the only things they notice.

OK... am going to stop their. Am getting worked up.

RCH


#VoteThemOut

>hehehe<

 

[Kent C]

Only because a respectful minority stand up for their rights. Far to many others are frightened, and far more could care less.

If some incumbent elected official (Federal, State, Local. Sheriff, Judge or Rep), any incumbent is up for election... vote them out.
Next election, vote out that incumbent.
Rinse and repeat for the next twenty to twenty-five years and maybe, hopefully the politicians will learn to fear us.

For money and fear are the only things they notice.

OK... am going to stop their. Am getting worked up.

RCH


#VoteThemOut

>hehehe<

I'm more inclined to find out how they vote (not what they say) and base my decision on that But I understand the sentiments.

 

[RCHagy74]

I'm more inclined to find out how they vote (not what they say) and base my decision on that But I understand the sentiments.

Heh, I have a problem with how they vote as well. Even If/when I agree with the vote, I still have a nagging suspicion that there is a motive other than the best interest of the voters at play.

A feint, within a feint, within a feint.

 

[Kent C]

Heh, I have a problem with how they vote as well. Even If/when I agree with the vote, I still have a nagging suspicion that there is a motive other than the best interest of the voters at play.

A feint, within a feint, within a feint.

You'll never know motive, only action. You can assume, conjecture, hypothesize motive from actions - "when a long train of abuses and usurpations, pursuing invariably the same Object evinces a design..." (T.Jefferson)....

 

[RCHagy74]

You'll never know motive, only action. You can assume, conjecture, hypothesize motive from actions - "when a long train of abuses and usurpations, pursuing invariably the same Object evinces a design" (T.Jefferson)....

Would it be bad form to re-write my post and make you look silly?

You are correct though, I am inferring a motive or motives from an action or series of actions.

One good quote deserves another though:

We have warned them from time to time of attempts by their legislature to extend an unwarrantable jurisdiction over us.
We have reminded them of the circumstances of our emigration and settlement here.
We have appealed to their native justice and magnanimity, and we have conjured them by the ties of our common kindred to disavow these usurpations, which, would inevitably interrupt our connections and correspondence.
They too have been deaf to the voice of justice and of consanguinity. We must, therefore, acquiesce in the necessity, which denounces our Separation, and hold them, as we hold the rest of mankind, Enemies in War, in Peace Friends.

Many bring up the Constitution. I find the Declaration to be the more pertinent document to much of what is happening between the citizenry and government today. It is just as relevant today (if not more so) as it was then.

 

[Kent C]

RCHagy74:Would it be bad form to re-write my post and make you look silly?

You could, but I quoted you

You are correct though, I am inferring a motive or motives from an action or series of actions.

One good quote deserves another though:

We have warned them from time to time of attempts by their legislature to extend an unwarrantable jurisdiction over us.
We have reminded them of the circumstances of our emigration and settlement here.
We have appealed to their native justice and magnanimity, and we have conjured them by the ties of our common kindred to disavow these usurpations, which, would inevitably interrupt our connections and correspondence.
They too have been deaf to the voice of justice and of consanguinity. We must, therefore, acquiesce in the necessity, which denounces our Separation, and hold them, as we hold the rest of mankind, Enemies in War, in Peace Friends.

Many bring up the Constitution. I find the Declaration to be the more pertinent document to much of what is happening between the citizenry and government today.

Why I also quoted the D of I

It is just as relevant today (if not more so) as it was then.

I agree. The 'long train of abuses' then is a Lionel train compared to the Bullet Train we have now.

 

[RCHagy74]

Why I also quoted the D of I

I had to look it up... It tickled a memory, yet, I could not recall from memory which historical doc it came from.

What I get for taking so long to read it again.

Tomorrow, the Constitution!

 

[Kent C]

I had to look it up... It tickled a memory, yet, I could not recall from memory which historical doc it came from.

What I get for taking so long to read it again.

Tomorrow, the Constitution!

Jefferson was in France (minister plenipotentiary - having full (plenus) power (potentia) to make independent decisions) during the Constitutional Convention. However his letters to and from Madison, kept him informed and did make him part of some of the ideas contained - esp. wrt the Bill of Rights which came later., of course.

 

[Bill Godshall]

Hate to say "I told you so," but I correctly predicted Zeller would replace TPSAC Chair Jonathan Samet on July 22, 2014.
http://www.e-cigarette-forum.com/fo...hol-report-orders-fda-reconstitute-tpsac.html

 

[Bill Godshall]

It would be helpful if an administrator moved this thread to the FDA section.

 

[Jman8]

Now we just have to dig deep into the replacements histories... yay.

Decided to do this.

First chose to go reread portions of the Leon ruling as I wanted to understand what makes for conflict of interest. Noticed that it is both of the financial variety (which is what FDA has seemingly chosen to avoid) and the 'appearance of conflict of interest' which I see the FDA as still actively engaged in.

Chose to look into new TPSAC member Dr. Fagan's history and after some poking around, found this (from 2006):

State-of-the-Science Conference Statement
To establish the baseline of what is currently known, COPYRIGHTDMCA Fagan, Ph.D., M.P.H., of the National Cancer Institute, presented the NIH’s State-of-the-Science Conference Statement on Tobacco Use.
Developed in June 2006 and available on the NIH’s Web site, the State-of-the- Science Conference Statement clarified the types of cessation-treatment products and services that are effective. Consistent with the U.S. Public Health Service guidelines and recommendations from other sources, the State-of-the-Science statement found value in:
■ Mass media campaigns, especially when combined with counseling or other support services.
■ Providers advising patients to quit.
■ Increasing the unit price for tobacco products.
■ Reducing the cost of cessation therapies.
■ Culturally tailored, gender-specific and language-appropriate programs.
■ Strategies that institutionalize cessation services in health settings.
Much more needs to be learned and documented, however, about the consumers’ experience with tobacco-cessation products and services. Specifically, the conference statement mentions the need for more research on:
■ Tailoring cessation services to specific populations.
■ Making cessation treatment attractive and increasing demand for such treatment.
■ Understanding the media’s role in making treatment attractive.
■ Reducing barriers in implementing strategies to increase consumer demand for cessation products and services.
■ Understanding the reasons for the effectiveness of telephone-based counseling.
■ Evaluating the impact of financial incentives and public performance reporting
on increasing smoking cessation.
■ Determining the effectiveness of incorporating context into interventions to prevent or stop tobacco use.
■ Developing more effective pharmacotherapies and other treatment products.
Fagan clarified that no specific funding opportunities have arisen as yet from the State-of-the-Science Conference. She recommended exploring the NIH’s existing small grant programs and other such funding opportunities.

Found at this link:
http://www.tobacco-
cessation.org/PDFs/CD%20Conference%205-3-07%20Final%20Report.pdf

 

[classwife]

It would be helpful if an administrator moved this thread to the FDA section.

Post reported and thread moved to FDA Regulations

 

[SeniorBoy]

Sometime in the not to distant future: "Yes your honor. We complied with your ruling"

/ draw your own conclusions /

Next up:

COPYRIGHTDMCA Fagan, PhD, MPH

LINK ---> COPYRIGHTDMCA Fagan, PhD, MPH

Note those active grants. Perhaps drop her a email or call her at the appropriate time.

HTH

 

[DEA7H INC]

Sometime in the not to distant future: "Yes your honor. We complied with your ruling"

/ draw your own conclusions /

Next up:

COPYRIGHTDMCA Fagan, PhD, MPH

LINK ---> COPYRIGHTDMCA Fagan, PhD, MPH

Note those active grants. Perhaps drop her a email or call her at the appropriate time.

HTH

Well I did read part of her report titled "Smokers who try e-cigarettes to quit smoking: findings from a multiethnic study in Hawaii. Am J Public Health."

It seemed slightly more positive than some of the others I've read by folks.