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FDA Tobacco Panelists are Challenged
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American Council on Science and Health
April 30, 2010
Selective Conflicts of Interest
By Curtis Porter
Conflict of Interest: The Smoking Gun
According to the Wall Street Journal, “The U.S. Food and Drug Administration rejected a request by cigarette giant Philip Morris USA to remove four members of a key tobacco-products advisory panel that the company said had extensive conflicts of interest.” The panel is intended to assess the role of smokeless tobacco products as a means of harm reduction for addicted smokers.
“In this case, I have to agree with Philip Morris, i.e. Altria,” says ACSH’s Dr. Elizabeth Whelan. “These panelists are biased. In these days of full disclosure and removing people from panels for financial conflicts, it appears that now the FDA is going to allow this purportedly impartial panel to include people who have interests in selling ineffective nicotine patches and gum while decrying the use of effective harm reduction methods, such as smokeless tobacco.”
ACSH’s Dr. Gilbert Ross agrees: “Those named in the Philip Morris action are well-known zealots who are the farthest thing from what they should be: neutral advisors.”
“To me, this is evidence that the broader conflict of interest debate is being used as a political tool that has nothing to do with actual conflicts of interest,” says ACSH’s Jeff Stier. “When ideologues who decry ‘conflicts of interest’ can use them to promote their policy agenda, they use the term rather broadly, and say that they want to avoid even the appearance of conflict of interest. Yet when the conflict of interest issue undermines their policy agenda, as it does here, they not only ignore the appearance of conflict, but actual conflicts of interest.”
April 30, 2010
Selective Conflicts of Interest
By Curtis Porter
Conflict of Interest: The Smoking Gun
According to the Wall Street Journal, “The U.S. Food and Drug Administration rejected a request by cigarette giant Philip Morris USA to remove four members of a key tobacco-products advisory panel that the company said had extensive conflicts of interest.” The panel is intended to assess the role of smokeless tobacco products as a means of harm reduction for addicted smokers.
“In this case, I have to agree with Philip Morris, i.e. Altria,” says ACSH’s Dr. Elizabeth Whelan. “These panelists are biased. In these days of full disclosure and removing people from panels for financial conflicts, it appears that now the FDA is going to allow this purportedly impartial panel to include people who have interests in selling ineffective nicotine patches and gum while decrying the use of effective harm reduction methods, such as smokeless tobacco.”
ACSH’s Dr. Gilbert Ross agrees: “Those named in the Philip Morris action are well-known zealots who are the farthest thing from what they should be: neutral advisors.”
“To me, this is evidence that the broader conflict of interest debate is being used as a political tool that has nothing to do with actual conflicts of interest,” says ACSH’s Jeff Stier. “When ideologues who decry ‘conflicts of interest’ can use them to promote their policy agenda, they use the term rather broadly, and say that they want to avoid even the appearance of conflict of interest. Yet when the conflict of interest issue undermines their policy agenda, as it does here, they not only ignore the appearance of conflict, but actual conflicts of interest.”
Was the title of this thread a Freudian slip? (I'm wearing mine right now--typed "Quit a few" instead of "Quite a few" in referring to people who use our favorite product.)
Penal - Of, relating to, or prescribing punishment, as for breaking the law
Therefore a "penalist" must be someone who prescribes punishment. That fits!
I left a comment on the WSJ article.
Penal - Of, relating to, or prescribing punishment, as for breaking the law
Therefore a "penalist" must be someone who prescribes punishment. That fits!
I left a comment on the WSJ article.
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Here's the AP story on the same issue
The Associated Press: FDA denied request to remove tobacco-panel members
The Associated Press: FDA denied request to remove tobacco-panel members
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Good article. And not surprising. The FDA is chock full of special interests and conflicts of interests. What's one more to add to the pile?
No surprises here. The panel members were hand picked to be orchestrated in the EXACT way the FDA and seperate groups WANT them to act. It's all show for the public eye, IMO. Anything PM says is null and void to the FDA and this panel of theirs, they will simply choose to ignore it and dismiss it. They know what they're doing, and everyone who knows what's going on knows it's all purely political moves for the public eye to be decieved into believing and trusting the FDA.
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If any can obtain PM's request to FDA (or FDA's letter of rejection), please post.
Don't know how meritorious PM's allegations were, and there are different types of conflict of interest.
But some members of the FDA advisory committee appear to have unreconcilable conflicts of interest (and perhaps challenges should be submitted to FDA) because they've advocated bans and/or extreme regulations for smokefreee tobacco/nicotine products, while also advocating for legislation (i.e. the new FDA tobacco law) that prohibits the FDA from banning far far deadlier cigarettes.
Imagine if the FDA appointed drug or food safety advisors who had made careers of advocating for bans and/or excessive regulations for the least hazardous drugs or food products, while also advocating legislation to prohibit the FDA from banning truly hazardous drugs or foods.
Imagine if the CPSC appointed advisors who had advocated banning and/or excessively regulating the least hazardous child toys, while also advocating legislation to prohibit the CPSC from banning the most hazardous child toys.
Imagine if the EPA appointed advisors who had advocated banning and/or excessively regulating the least hazardous pollutants, while also advocating legislation to prohibit the EPA from banning the deadliest pollutants.
Imagine if the DOT appointed advisors who had advocated banning and/or excessively regulating the safest and most fuel efficient cars, while also advocating legislation to prohibit the DOT from banning the least safe and least fuel effecient cars.
Greg Connolly campaigned to ban snus in the EU, Australia, NZ and Hong Kong, has claimed that snus didn't help reduce male smoking rates in Sweden (yet surveys found that 25% of male smokers in Sweden quit by switching to snus), and has done more than anyone else in the world to mislead the public to believe that smokeless tobacco is as hazardous as cigarettes. Meanwhile, Connolly also aggressively advocated US Congress to enact legislation (i.e. the FDA tobacco law) that specifically prohibits the FDA from banning far more hazardous cigarettes. Connolly also has stated his support for the FDA to ban e-cigarettes (unless/until it is proven "safe and effective" as a smoking cessation drug).
During the past decade, Jack Henningfield has received massive amounts of money from GlaxoSmithKline (via Pinney Assoicates) for opposing tobacco harm reduction products and policies, for exaggerating the health risks of smokeless tobacco, for not include "switching to smokeless" in his extensive writings on ways to quit smoking, and for advocating extreme criteria for smokeless products to make "reduced risk" claims,
has advocated for banning e-cigarettes (unless/until they are approved as "safe and effective" smoking cessation aids). Meanwhile, Henningfield (and others at Pinney Associates) also advocated legislation to prohibit the FDA from banning far deadlier cigarettes.
Jonathan Samet, Chair of the FDA tobacco advisory committee spoke at the FDA's July 22, 2009 press conference (he was invited by FDA Deputy Commissioner Josh Sharfstein) misrepresenting the health/safety risks of e-cigarettes and advocating the FDA's attempted ban on them.
Similar to Connolly and Henningfield, Hatsukami also has made a career of exaggerating the risks of smokeless tobacco, advocating extreme criteria for smokeless tobacco products to make "reduced risk" claims, while also advocating the legislation prohibiting the FDA from banning far deadlier cigarettes.
For the past few years, Mark Clanton has worked for the American Cancer Society, which advocated for bans and extreme regulations on smokeless tobacco products, has intentionally confused smokers to believe that smokeless is just as hazardous
as cigarettes, and has urged the FDA to ban e-cigarettes. Meanwhile, the ACS also aggressively lobbied Congress to enact legislation that prohibits the FDA from banning cigarettes.
Another conflict of interest is that some members of the FDA tobacco advisory committee have received lots of money from drugs companies to promote NRT (and other Rx drugs) as the only proven methods for quitting smoking. Meanwhile, those same drug companies directly compete against smokeless tobacco products and e-cigarettes (as they have many similarities) as well as cigarettes. So they have had financial incentives to advocate for excessive regulations on tobacco products (especially smokefree products).
Another conflict of interest is that Henningfield and Benowitz have advocated for the FDA to impose mandatory nicotine reductions in cigarettes (and eventually ban nicotine in cigarettes), which would result in many smokers smoking even more cigarettes (to obtain the nicotine their body craves), increased cigarette sales, increased smoking diseases and deaths, and eventually (when nicotine is banned) would create a huge black market for cigarettes containing nicotine. Instead of demonstrating sound product regulatory judgement, that's anti-smoker extremism and prohibitionism.
Don't know how meritorious PM's allegations were, and there are different types of conflict of interest.
But some members of the FDA advisory committee appear to have unreconcilable conflicts of interest (and perhaps challenges should be submitted to FDA) because they've advocated bans and/or extreme regulations for smokefreee tobacco/nicotine products, while also advocating for legislation (i.e. the new FDA tobacco law) that prohibits the FDA from banning far far deadlier cigarettes.
Imagine if the FDA appointed drug or food safety advisors who had made careers of advocating for bans and/or excessive regulations for the least hazardous drugs or food products, while also advocating legislation to prohibit the FDA from banning truly hazardous drugs or foods.
Imagine if the CPSC appointed advisors who had advocated banning and/or excessively regulating the least hazardous child toys, while also advocating legislation to prohibit the CPSC from banning the most hazardous child toys.
Imagine if the EPA appointed advisors who had advocated banning and/or excessively regulating the least hazardous pollutants, while also advocating legislation to prohibit the EPA from banning the deadliest pollutants.
Imagine if the DOT appointed advisors who had advocated banning and/or excessively regulating the safest and most fuel efficient cars, while also advocating legislation to prohibit the DOT from banning the least safe and least fuel effecient cars.
Greg Connolly campaigned to ban snus in the EU, Australia, NZ and Hong Kong, has claimed that snus didn't help reduce male smoking rates in Sweden (yet surveys found that 25% of male smokers in Sweden quit by switching to snus), and has done more than anyone else in the world to mislead the public to believe that smokeless tobacco is as hazardous as cigarettes. Meanwhile, Connolly also aggressively advocated US Congress to enact legislation (i.e. the FDA tobacco law) that specifically prohibits the FDA from banning far more hazardous cigarettes. Connolly also has stated his support for the FDA to ban e-cigarettes (unless/until it is proven "safe and effective" as a smoking cessation drug).
During the past decade, Jack Henningfield has received massive amounts of money from GlaxoSmithKline (via Pinney Assoicates) for opposing tobacco harm reduction products and policies, for exaggerating the health risks of smokeless tobacco, for not include "switching to smokeless" in his extensive writings on ways to quit smoking, and for advocating extreme criteria for smokeless products to make "reduced risk" claims,
has advocated for banning e-cigarettes (unless/until they are approved as "safe and effective" smoking cessation aids). Meanwhile, Henningfield (and others at Pinney Associates) also advocated legislation to prohibit the FDA from banning far deadlier cigarettes.
Jonathan Samet, Chair of the FDA tobacco advisory committee spoke at the FDA's July 22, 2009 press conference (he was invited by FDA Deputy Commissioner Josh Sharfstein) misrepresenting the health/safety risks of e-cigarettes and advocating the FDA's attempted ban on them.
Similar to Connolly and Henningfield, Hatsukami also has made a career of exaggerating the risks of smokeless tobacco, advocating extreme criteria for smokeless tobacco products to make "reduced risk" claims, while also advocating the legislation prohibiting the FDA from banning far deadlier cigarettes.
For the past few years, Mark Clanton has worked for the American Cancer Society, which advocated for bans and extreme regulations on smokeless tobacco products, has intentionally confused smokers to believe that smokeless is just as hazardous
as cigarettes, and has urged the FDA to ban e-cigarettes. Meanwhile, the ACS also aggressively lobbied Congress to enact legislation that prohibits the FDA from banning cigarettes.
Another conflict of interest is that some members of the FDA tobacco advisory committee have received lots of money from drugs companies to promote NRT (and other Rx drugs) as the only proven methods for quitting smoking. Meanwhile, those same drug companies directly compete against smokeless tobacco products and e-cigarettes (as they have many similarities) as well as cigarettes. So they have had financial incentives to advocate for excessive regulations on tobacco products (especially smokefree products).
Another conflict of interest is that Henningfield and Benowitz have advocated for the FDA to impose mandatory nicotine reductions in cigarettes (and eventually ban nicotine in cigarettes), which would result in many smokers smoking even more cigarettes (to obtain the nicotine their body craves), increased cigarette sales, increased smoking diseases and deaths, and eventually (when nicotine is banned) would create a huge black market for cigarettes containing nicotine. Instead of demonstrating sound product regulatory judgement, that's anti-smoker extremism and prohibitionism.
Yes, and Dorothy Hatsukami, who has worked closely with Henningfield in the past, presented results at SRNT showing that a zero nicotine tobacco cigarette is an effective smoking-cessation method. Her methods and results are questionable, but will no doubt be used as "proof" by the FDA that it's a good idea to require lowered nicotine levels in cigaretes.
I concur with your opinion, Bill. I, for one, more than doubled the number of cigarettes I smoked when I switched to lights in the 1980s.
The tobacco control community loves to point the finger at tobacco companies for the unexpected results of promoting reduced tar and nicotine cigarettes (lights). And yet, here they go saying, "Hey, wouldn't it be a great idea to lower the nicotine level in cigarettes?"
Duh?
No!
Not unless your goal is to greatly increase the rates of lung diseases.
from the report at "Huffing-ton" Post (in honor of Freud
):So it appears Big Ph exceeds Big Tobacco in the money game, by far.
I must have originally read a different version of this story because the first time I heard of this, I noticed that the article mentioned that the people from Altria/Philip Morris were non-voting members of the committee. That confirms my suspicion that BT has very little if anything to do with the FDA's opposition of reduced harm. This makes sense because tobacco companies have motivation for reducing harm: Keeping their customers alive. Big Pharma, on the other hand, could care less about saving lives--as long as they keep FDA's pockets lined, they can continue running commercials for kid-friendly nicotine with all the same carcinogens and toxins found in e-cigarettes and psychoactive drugs with documented lethal side effects while the FDA tries to convince us that using COLOR on packaging is "misleading".
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Most tobacco companies now endorse tobacco harm reduction, and have joined with me and other tobacco harm reduction advocates from the public health community in advocating government health agencies and regulatory bodies to truthfully inform tobacco consumers about the comparable risks of different tobacco/nicotine products.
Per Kauai Kai's posting, while drug industry revenues and profits continue climbing, sales of all NRT products in the US have remained steady at about $600 million anually since 2000. Meanwhile, sales of tobacco products have grown to about $100 billion annually, and are likely to continue climbing. For comparison, e-cigarette sales were an estimated $100 - $200 million last year in the US, and could surpass NRT sales in 2010.
Per Kauai Kai's posting, while drug industry revenues and profits continue climbing, sales of all NRT products in the US have remained steady at about $600 million anually since 2000. Meanwhile, sales of tobacco products have grown to about $100 billion annually, and are likely to continue climbing. For comparison, e-cigarette sales were an estimated $100 - $200 million last year in the US, and could surpass NRT sales in 2010.
Bill Godshall, nice find. You're a good man and it's a privilege to have you among our ranks in the good fight.
Do you have a study or chart available that compares all the ingredients in ecigs(smokefree cigarettes) to combustible cigarettes? It would be nice to also have a description of all the ingredients in smokeless cigarettes and any study showing their safety and also their uses in other products. Can you find such a comparison chart and explanation for me? It would be quite useful. Thank you
The entire list of stuff in cigarettes has been posted elsewhere on this forum, and it is very, very long. Another fly in the ointment is that combustion changes the chemistry. So while you start out with X chemicals in the unlit cigarette, you end up with X * Y chemicals in the smoke.
http://www.e-cigarette-forum.com/forum/vapor4life/83452-whats-cigarette.html
Here is a poster published by the American Heart Association that lists some of the more egregious chemicals.
http://www.americanheart.org/downloadable/heart/1221772609034What About Cigarettes Poster.pdf
A brief chart comparing some ingredients in conventional cigarettes to e-cigarettes can be found on the Health New Zealand site: Ecigarette mist harmless, inhaled or exhaled
For more info on the carcinogens in e-cig liquid, see Table 2.2 on page 7 of this HNZ report: http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf
Note that the quantity in the 16 mg. cartridge matches the nictoine patch. That's the amount in the liquid.
This report shows that nothing that is carcinogenic makes it into the vapor
https://docs.google.com/fileview?id...1NC00N2MxLWJmYTctMWExNGU4ZjgwYWUz&hl=en&pli=1
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