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FDA goes up in smoke

Carl Heneghan
Last edited 22nd June 2009
Over a cup of coffee, in one of those shabby railway cafes you get round England, I came across this story in the New Scientist. I couldn’t quite believe what I was reading and therefore decided to buy my first ever issue of the New Scientist - which is quite expensive at £3.25 – to lighten the train journey. The story goes like this. The US food and drug administration (FDA) is potentially going to get the job of regulating the tobacco industry. I can see it now; smoke this lighter brand of FDA approved cigarettes. Now this has to be a joke but it isn’t, as tobacco companies have begun ‘clinical trials’. A clinical trial as defined by wordnet.princeton.edu/perl/webwn is a rigorously controlled test of a new drug on human subjects, and in the United States it is conducted under the direction of the FDA before being made available for general clinical use. Cigarettes companies are developing a range of prototype lighter cigarettes. I think I’ve heard of these before - they are called lights. The worst of it is BAT has started a trial on 250 smokers who are either given normal cigarettes or prototypes. Now I have had some problems with ethics committees before; but, if you can get away with randomizing someone to one of two killers then I can’t see why there is a need for ethical committees. Here is the best of it though; they are only using a surrogate of urine toxins to see which cigarette lowers them and then relating this to potential cardiovascular reductions. You may be sitting there like me thinking what a load of rubbish, they will never get away with this. Well, the US senate has voted on it this week, and when you think that the World Health Organization predicts by 2030, 80% of tobacco related deaths will be in low to middle income countries, then this decision could worsen the gains made in recent years in reducing the numbers smoking.
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Mixed roles=conflict of interest

The New England Journal of Medicine has an editorial on this subject this week:

http://content.nejm.org/cgi/content/full/361/4/402

"The center is charged with regulating tobacco products for the explicit purpose of protecting the health of the public. The FDA will now have the authority to require that all ingredients, compounds, and additives in tobacco products be reported to the agency, and those found to have harmful health effects may be banned. Nicotine levels in cigarettes may be regulated, but neither nicotine nor cigarettes may be banned outright."

I am concerned by the "those found to have harmful effects may be banned". As Dr Carl says, we already know that cigarettes are killers. I guess the only encouraging part is that the FDA is targetting protection of children and banning tobacco advertising. The point of debate is whether the tobacco industry will do less harm when it is regulated by a government or whether this is a (not very) covert way for the industry to get right into the heart of the US government.

fda and smoking

seems most people think this smoking law and the fda approva is good news
http://abcnews.go.com/Politics/Health/story?id=7897525&page=1

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