FDA Judge Leon strikes again, rules FDA TPSAC had "conflicts of interest", quashes menthol report, orders FDA to reconstitute TPSAC

[Bill Godshall]

Judge Richard Leon strikes again, rules FDA TPSAC had "conflicts of interest", quashes menthol report, orders FDA to reconstitute TPSAC
RICHMOND, Va.: Judge: FDA can't use tobacco panel menthol report | Business | NewsObserver.com

Looks like Mitch Zeller is now looking for a replacement for Jonathan Samet, who has chaired TPSAC since its creation.

But don't expect Zeller (who has had even more conflicts of interest than Samet) to appoint any objective researchers or anyone who has acknowledged that e-cigs are far less hazardous than cigarettes, helped more than a millions smokers quit smoking, are consumed almost exclusively by smokers and former smokers (who switched to vaping), and/or that e-cigs aren't addicting nonsmokers.

Instead, Zeller will appoint someone who will promote Zeller's regulatory agenda and who will follow Zeller's instructions (and who can read really really fast and swiftly evaluate the 100,000+ page MRTP application filed by Swedish Match, and the estimated 25 New tobacco Product applications for e-cigs if/when FDA issues a Final Rule for its proposed deeming regulation).

 

[Bill Godshall]

Here's Richard Craver's article in the Winston-Salem Journal
Judge: FDA can

Of course, Big Pharma funded CTFK's Matt Myers (who has even more Big Pharma conflicts of interests than the 3 TPSAC members) urged FDA to double down yet again by saying the conflicted TPSAC members are "the best scientific minds available", by urging the FDA to appeal Judge Leon's ruling, and by urging FDA to ban menthol (which would result in FDA getting sued yet again, and likely losing yet again).

Although Zeller would like to ban or sharply limit menthol in cigarettes, I suspect Zeller may not heed Myers' advice (as Lawrence Deyton did on many occassions) because he doesn't want the FDA to keep losing in court.

As expected, anti-tobacco advocacy groups urged the U.S. Justice Department to appeal Leon’s ruling.

Matthew Myers, executive director of the Campaign for Tobacco-Free Kids, said the ruling “would not only deprive the tobacco advisory committee of the best scientific minds available, but could also impact the FDA’s broader ability to carry out its mission and protect public health.”

Myers urged the FDA to “move forward to ban the sale of menthol cigarettes based on the conclusions of its own, independent scientific review of the public health impact.”

 

[Kent C]

I urge everyone to read the whole piece. There's a wealth of information as to 'how things work' here. And there is some 'ammo' for our comment period, wrt to studies being used against ecigs and flavoring. Here's the judge:

"In his order Monday, Leon said the FDA erred in determining that the members didn't have conflicts of interest and therefore, the agency's appointment of those members was "arbitrary and capricious," and tainted both the panel and its work.

"Conflicts of interest — whether actual or perceived — undermine the public's confidence in the agency's decision-making process and render its final product suspect, at best," he wrote."

As has been pointed out in earlier posts here, Zeller, especially in comments made in the Senate HELP committee (but elsewhere as well), has the earlier 2009 decision in mind (he winces) when coming close to the aspects of that earlier court decision. Imo, he's more afraid of the courts than any pro-ecig senators. When Harkin was being rather pointed on the idea of banning, Zeller 'reminds him' of the court's decision, almost in a way of throwing his hands up in the air - as if that aspect is out of his control..... I'm 'paraphrasing' here but anyone who paid attention should know of what I speak. Again, imo, this is a hot point for Zeller.

And on the judge's statements, one could call into question, any of the studies made with the $270 million dollars the FDA got for studies along these same lines of 'actual or perceived' conflicts.

By the same token 'our studies' could come under the same scrutiny.

 

[Bill Godshall]

For background info, here's an article from 2011 announcing the lawsuit by Lorillard and Reynolds against FDA
JURIST - Tobacco companies file lawsuit against FDA advisory panel


Looks like FDA probably won't be appointing anyone to TPSAC who still receives funding from Big Pharma or who has testified as an expert witness against a tobacco company. I suspect the FDA also won't appoint anyone to TPSAC who is receiving FDA funding (as that also is likely to be perceived as a conflict of interest).


Kent wrote:

And on the judge's statements, one could call into question, any of the studies made with the $270 million dollars the FDA got for studies along these same lines of 'actual or perceived' conflicts.

By the same token 'our studies' could come under the same scrutiny.

Although "one could call into question" any studies on e-cigs (and doing so would help our cause), Judge Leon's ruling on this case won't have any legal, public policy or news media impact on any FDA research except for TPSAC's report on menthol cigarettes.

 

[DrMA]

Excellent! I'm glad there are still people in power today who can objectively evaluate and recognize conflicts of interest when it comes to the tobacco field.

Edit: this is another wonderful opportunity to remind the FDA that it cannot arbitrarily and capriciously deem ecigs as tobacco products, based on biased research, unsupported conjecture, and malicious propaganda from the fatally conflicted tobacco control field.

 

[Kent C]

Thanks for posting this, Bill. I think it is a significant development. It is evident how effective the tobacco companies can be with the money they have (from many of us, I might add), and while I don't give them a pass on trying to corner the ecig market, and praising the proposed deeming, but this, imo, helps our cause, if only in pointing out that certain studies are obviously intended for only one purpose - that of the FDA's - not of science and objectivity.

 

[Bill Godshall]

Since FDA's TPSAC menthol cigarette report misrepresented the scientific evidence (by falsely claiming menthol cigarettes are more addictive, more hazardous and more difficult to quit than nonmenthol cigarettes), and since the TPSAC report dismissed/ignored the potential of a menthol ban creating a huge black market (and only cited one survey citing some menthol smokers saying they might quit smoking if menthol was banned), I'm pleased Judge Leon struck down TPSAC's report on menthol.


The real irony about menthol cigarettes is that CTFK's Matt Myers negotiated and agreed to the FSPTCA deal with Philip Morris in 2004, which exempted menthol from the FSPTCA's list of banned flavorings (even though menthol accounted for >99% of all flavored cigarettes on the market and smoked by teens).

Then in 2007, when I convinced Mike Enzi to offer an amendment to the FSPTCA to actually ban menthol cigarettes (and to require graphic warnings covering 50% of cigarette packs), CTFK defended its dirty deal with Philip Morris by falsely accusing Enzi's amendments of being "poison pills" and a "Trojan Horse" to destroy the FSPTCA. While Enzi's graphic warning amendment was approved by the Senate HELP Cmte, the proposed menthol ban was not.

BTW I never supported the menthol ban proposed by Enzi, but thought it important for the US Senate to consider (especially since CTFK, ACS, AHA, ALA, Kennedy, Waxman et al were falsely claiming that the FSPTCA's cigarette flavoring ban was necessary to "protect public health and children from Big Tobacco").

Only after the FSPTCA was signed into law in 2009 did CTFK's Myers begin calling for FDA to ban menthol cigarettes "to protect the children". Unfortunately, the news media (especially Felberbaum at AP) hasn't exposed any of Matt Myers' hypocrisy since 1997 when Myers endorsed and lobbied for the Global Tobacco Settlement that would have given the cigarette industry immunity from lawsuits.

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.

 

[Kent C]

Although "one could call into question" any studies on e-cigs (and doing so would help our cause), Judge Leon's ruling on this case won't have any legal, public policy or news media impact on any FDA research except for TPSAC's report on menthol cigarettes.

I fully understand the specificity involved in the decision. It's the wider concept of bias that is shown that could be used for PR purposes in the same way that the anti-ecig studies conflate tobacco and nicotine, flavors and kids, etc. that can be shown to be just as biased and perhaps challenged in court. And I don't mean as just a 'bluff' but perhaps a true challenge using 'legal defense funds' when and if that circumstance arises.

 

[DrMA]

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/show_public_doc?2011cv0440-82

 

[Jman8]

But don't expect Zeller (who has had even more conflicts of interest than Samet) to appoint any objective researchers or anyone who has acknowledged that e-cigs are far less hazardous than cigarettes, helped more than a millions smokers quit smoking, are consumed almost exclusively by smokers and former smokers (who switched to vaping), and/or that e-cigs aren't addicting nonsmokers.

Then this would work to our advantage even more than if they went the route of integrity. Would open them, very easily, to same type of ruling if TPSAC tried to conclude things about eCigs that only ANTZ can support, and that independent researchers find, even slightly, different results with.

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.

 

[Jman8]

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.

 

[Jman8]

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/show_public_doc?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"

 

[WorksForMe]

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.

 

[sonicdsl]

Bringing over rothenbj's post from a duplicate thread:

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/2014_07_01_archive.html

 

[Bill Godshall]

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.

 

[Jman8]

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.

 

[Kent C]

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/cold-war-against-global-warming-skeptics-continues

http://www.politico.com/blogs/media/2014/03/sharyl-attkisson-to-leave-cbs-news-184836.html