Judge Leon strikes again, rules FDA TPSAC had "conflicts of interest", quashes menthol report, orders FDA to reconstitute TPSAC - Page 2
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Thread: Judge Leon strikes again, rules FDA TPSAC had "conflicts of interest", quashes menthol report, orders FDA to reconstitute TPSAC

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    PV Master ECF Veteran Jman8's Avatar
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    Quote Originally Posted by Bill Godshall View Post
    Had we not defeated that Global Tobacco Settlement (by defeating Sen. John McCain's bill in the US Senate in 1998), none of the recent string of lawsuit victories by injured smokers against cigarette companies in Florida would have occurred.
    ... which would be a good thing.
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    Quote Originally Posted by DrMA View Post
    If anyone is interested, here is Judge Leon's memorandum opinion in this case (Civil Action No. 2011-0440; LORILLARD INC et al v. UNITED STATES FOOD AND DRUG ADMINISTRATION et al):

    https://ecf.dcd.uscourts.gov/cgi-bin...?2011cv0440-82
    IMO, this is a very significant excerpt (from p.24) from the ruling, moving forward:

    But not withstanding how narrowly Congress drafted this specific conflicts provision, other general conflicts laws apply to FDA's composition of the Committee, and failure to adequately consider potential conflicts arising from the opposite end of the spectrum--i.e. entities with interests adverse to tobacco companies--would amount to "fail[ure] to consider an important aspect of the problem"

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    If the Proposed Regulations are based in part on reports and recommendations from TPSAC and the same “Challenged Members” especially Samet, I would think it would leave the FDA open to challenge on the same grounds. I hope there are lawyers looking at that possibility already. I’m not sure how such an effort would be funded, but if partial crowd-funding were necessary, I’d be willing to contribute.


    Further, plaintiffs allege that defendants violated the APA by appointing a committee lacking “fair[] balance[] in terms of the points of view represented” and exhibiting “special interest” influence, in violation of FACA,
    We all know this fits our situation as well, but it might be hard to prove.

    J.R.
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    Bringing over rothenbj's post from a duplicate thread:

    Quote Originally Posted by rothenbj View Post
    I'm starting to love this guy!


    Tobacco Truth: Federal Judge to FDA: Tobacco Advisory Panel Tainted by Conflicts of Interest

    “The presence of conflicted members on [FDA Tobacco Products Scientific Advisory Committee, TPSAC] irrevocably tainted its very composition and its work product” and “the Committee’s findings and recommendations…are, at a minimum, suspect, and, at worst, untrustworthy.”So ruled federal judge Richard Leon this week



    Dr Siegel also addresses it in his blog-

    http://tobaccoanalysis.blogspot.com/...1_archive.html
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    Jman wrote

    I would expect people who claim to be scientific, to follow professional integrity of science, or be called out by scientific bodies (at very least) and possibly by legal authorities if attempting to engage in overreach that impacts the general public.
    That's what I believed until a decade ago when it became obvious that the US SG, CDC and other DHHS agencies, NIH, IOM, most researchers and most scientific bodies have been knowingly and intentionally misrepresenting the scientific evidence about the comparable risks of cigarettes versus noncombustible tobacco/nicotine products.

    In response to my (and other's) criticism of their scientific misrepresentations and financial conflicts of interest, they refused to return my calls and e-mails, refused to respond to my web postings, threw me off their e-mail listserves, and banned me from presenting at tobacco control and tobacco science conferences.

    I suspect that Judge Leon's ruling will prompt Zeller to replace everyone on TPSAC who has received Big Pharma funding during the past several years (to avoid losing more lawsuits, and to avoid having to repeat many TPSAC processes/reports like Swedish Match's MRTP application and future New Tobacco Product applications).

    I doubt that Zeller would try to replace them with those who have received the $270 million in Tobacco Regulatory Science funds from FDA, especially after Jed Rose publicly criticized FDA for giving funds to its TPSAC members despite higher rated applications submitted by other researchers.

    But I suspect Zeller will replace them with ANTZ who have received funding from NIH to misrepresent the scientific evidence on tobacco/nicotine product risks. For the past two decades, NIH (primarily through NCI) has funded many ANTZ, as has the CA Dept of Health to misrepresent the risks of OTP and e-cigs.
    Last edited by Bill Godshall; 07-25-2014 at 07:54 PM.

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    Quote Originally Posted by Bill Godshall View Post
    That's what I believed until a decade ago when it became obvious that the US SG, CDC and other DHHS agencies, NIH, IOM, most researchers and most scientific bodies have been knowingly and intentionally misrepresenting the scientific evidence about the comparable risks of cigarettes versus noncombustible tobacco/nicotine products.

    In response to my (and other's) criticism of their scientific misrepresentations and financial conflicts of interest, they refused to return my calls and e-mails, refused to respond to my web postings, threw me off their e-mail listserves, and banned me from presenting at tobacco control and tobacco science conferences.
    Well, this plain sucks, at least the way you are explaining it.

    But I stand by what I was saying because of "integrity of science." Science has been known, historically, to go in the 'wrong' direction for decades (if not centuries). But then to correct itself. While popular science is in that wrong direction, there are likely instances where other scientists are indicating it is the wrong direction and either providing evidence or opinion to the 'popular community.' And those people being shunned and ignored as out of step with 'scientific consensus.' But, if it is actually science we are talking about, it will correct itself. Doesn't really need humans to have this occur, nor advocates, cause - it is what it is.

    I think we see lots of scenarios in recent times where 'popular science' is allowing scientific community, and general public, to be mislead. And a sense of pride that often seems to accompany the side doing the misleading, as if righteousness and dogma have a place in science. And because of this, science has become, yet another human endeavor that polarizes beliefs, and can at times show up as lacking integrity. Quieting naysayers, shunning minority opinion, and acting as if current meme is the only way to appropriately understand an issue.

    I suspect that Judge Leon's ruling will prompt Zeller to replace everyone on TPSAC who has received Big Pharma funding during the past several years (to avoid losing more lawsuits, and to avoid having to repeat many TPSAC processes/reports like Swedish Match's MRTP application and future New Tobacco Product applications).

    I doubt that Zeller would try to replace them with those who have received the $270 million in Tobacco Regulatory Science funds from FDA, especially after Jed Rose publicly criticized FDA for giving funds to its TPSAC members despite higher rated applications submitted by other researchers.

    But I suspect Zeller will replace them with ANTZ who have received funding from NIH to misrepresent the scientific evidence on tobacco/nicotine product risks. For the past two decades, NIH (primarily through NCI) has funded many ANTZ, as has the CA Dept of Health to misrepresent the risks of OTP and e-cigs.
    And I see that as a win for us, in the long term. In the short term, the likes of you and I will be heavily critical of such replacements and will realize that for at least a little while, our side is screwed. Yet, I think this Leon ruling is that monumental, and that if Zeller dares go in direction of "all ANTZ (scientists) all the time," then the perception aspect that Leon brought up will rise again, and will likely come back and bite Zeller and cohorts, thus putting all their work and decisions into jeopardy.

    I also think this works for anti-smoking advocacy, and is what the Leon ruling is actually addressing, but as you and I may disagree on that type of data, I just assume keep this to the eCig issue and persuade you to realize that this ruling could have very significant ramifications with regards to eCig regulations and TPSAC.

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    Quote Originally Posted by Bill Godshall View Post
    In response to my (and other's) criticism of their scientific misrepresentations and financial conflicts of interest, they refused to return my calls and e-mails, refused to respond to my web postings, threw me off their e-mail listserves, and banned me from presenting at tobacco control and tobacco science conferences.
    1984-type fascism happens all over. Even here. And:

    http://www.freedomworks.org/content/...tics-continues

    http://www.politico.com/blogs/media/...ws-184836.html
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