Judge Richard Leon allows industry lawsuit challenging FDA TPSAC

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Bill Godshall

Executive Director<br/> Smokefree Pennsylvania
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Federal Judge Richard Leon rejects FDA request to dismiss industry lawsuit to prevent agency from relying upon TPSAC reports, challenging conflicts of interest and objectivity of agency appointed committee members.
Reynolds Suit Challenging FDA Panel Members Can Proceed - Businessweek


Excerpt

Reynolds and Lorillard, the second- and third-biggest U.S. cigarette makers, filed the complaint in February 2011. They sought an order to prevent the FDA from drawing on reports by the tobacco Products Scientific Advisory Committee, including one on menthol in cigarettes.

Three of the eight committee members “have severe financial and appearance conflicts of interest and associated biases,” the companies said in their complaint. The three members serve as paid expert witnesses in lawsuits against the tobacco industry and take money from drug companies that make nicotine-replacement products and other smoking-cessation aids, according to the complaint.

‘Similar Viewpoints’

The voting membership of the panel is “dominated by a clique of people with similar viewpoints on smokeless tobacco and other matters, including matters on which they have jointly published articles, and thus does not reflect the diversity of views on tobacco-related issues among the members of the public- health and tobacco-control communities,” according to an amended complaint.
 
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Placebo Effect

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A couple months ago I read the tobacco companies' letters that were sent to the FDA, the FDA's short and usually far from timely responses, and the briefs filed by at least one of the plaintiffs and the FDA. I don't think I ever got around to reading a plaintiff response brief, which would be interesting.

I walked away suspecting the tobacco companies could prevail with regards to 2 of the 3 TPSAC members they cited, but can't remember the specifics.
 

Berylanna

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Someone commented that "It looks like Big Tobacco bought themselves a judge" so I commented (probably too-hastily!) with this, which is comment 2 on the story, after stealing 4 links from somebody else's post. I'll edit to give the link credits tonight when I have more time.

, 0 minutes ago

It is more complicated than that. The FDA has recently started promoting smoking in preference to smokeless products by issuing press releases that do not even agree with the FDA's own test findings. They have also gotten weird over flavoring. They are ignoring medical research from Sweden, Italy, New Zealand,
Boston, and Utah regarding alternatives to smoking.

I don't like the tobacco companies, but at least they have the money to force the FDA to use ACTUAL scientific studies.

[1] Phillips, C.V. et al. You might as well smoke; the misleading and
harmful public message about smokeless tobacco. BMC Public Health 2005,
5:31doi:10.1186/1471-2458-5-31.

[2] Accortt, N.A., et al. Chronic Disease Mortality in a Cohort of
Smokeless Tobacco Users. American Journal of Epidemiology 2002; 156:730-
737

[3] Roth, H.D. et al. Health Risks of Smoking Compared to Swedish Snus. Inhalation Toxicology, 17:741-748, 2005.

[4] Gartner C.E, et al., Assessment of Swedish snus for tobacco harm
reduction: an epidemiological modeling study. Lancet. 2007 Jun
16;369(9578):2010-4
 
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