FDA REGULATION WILL DENY LIFE-SAVING STRATEGY!

 

NOW CHECK THIS OUT! In a recent edition of the Buffalo News Brad Rodu challenges the current FDA proposal as ignoring a life-saving strategy!

In an op-ed in Buffalo News, Dr. Brad Rodu, a professor of medicine with an endowed chair in tobacco harm reduction research at the University of Louisville, said the Family Smoking Prevention and Tobacco Control Act, which aims to give the Food and Drug Administration regulatory authority over tobacco products, is “fatally flawed” because it would “effectively prevent the nation’s 45 million smokers from learning that smokeless tobacco products are vastly safer alternatives.”   

The message about smokeless tobacco products is “critical to the life-saving strategy known as ‘tobacco harm reduction,'” Dr. Rodu said.  He cited a recent article in the medical journal Lancet, which said tobacco product regulation “should promote complete cessation of nicotine product use as the preferred option, but also encourage existing smokers who are unable to stop smoking to adopt a less hazardous source of the drug,” and should therefore apply the levers of affordability, promotion, and availability in direct inverse relation to the hazard of the product, thus creating the most favorable market environment for the least hazardous products.”   The Royal College of Physicians, whose report was the basis of the Lancet article, said that “low nitrosamine smokeless tobacco products may have a positive role to play in a coordinated and regulated harm reduction strategy which maximizes public health benefit,” Dr. Rodu noted.  The pending FDA legislation is the opposite of such a rational approach to helping smokers, and the bills fail to acknowledge that nicotine itself does not cause the diseases that kill smokers, he said.  “Congress should rewrite those portions of H.R. 1108 and S. 625 that impose irrational and dangerous limitations on the communication of truthful information about smokeless tobacco and its relative risk vis-a-vis cigarettes,” Dr. Rodu said (Buffalo News 11/12).

IS BRAD RIGHT OR WRONG? DO YOU KNOW OF ANYONE THAT HAS USED MOIST TOBACCO TO KICK THE SMOKING HABIT? DO YOU THINK CONGRESS WILL GET THE RIGHT MESSAGE? WHAT IS THAT MESSAGE? IS THERE ANYTHING WE CAN DO? IS THERE ANYTHING WE SHOULD DO? ANY THOUGHTS ON HOW PM WILL APPROACH THIS NOW THAT THEY ARE TESTING MOIST TOBACCO? DO YOU BELIEVE AS BRAD MENTIONS THAT NICOTINE IS NOT THE EVIL? SO MANY THOUGHTS I HAVE BUT WHAT ARE YOUR THOUGHTS ON THIS ISSUE?

30 comments ↓

#1 JD on 11.29.07 at 1:17 AM

Well I quess Brad has a point. It should be real interesting to see how Philip Morris changes their position on this issue. First I ever heard of something like this. Using Smokeless to quit smoking. Is this a reason so many people are looking at pouches. The pouches seem to be picking up real well in my locations. Are the tobacco companies like USST trying to get this message to congress. Is it really true that smokeless is really that much safer? I never knew that.

#2 monte cristo on 11.29.07 at 10:53 PM

It’s apparent to me that PM will change their tune soon especially since they are investing so heavily in “harm reduction” at their new research facility.

#3 The OTP Kid on 12.03.07 at 6:13 PM

PM wants FDA because they are the only company equipped to manage it to their advantage. It would be nice if every event in the industry quit inviting them to speak so they wouldn’t have a platform to manage the message to the trade. People need to wise up and get off the addiction of the money they supply the trade for shows and events. They have one agenda: world domination!

#4 Legend on 12.09.07 at 11:01 AM

I think the flaw with the snus products will be convincing smokers that it is actually an alternative. I have never known anyone to use OTP to quit smoking and believe that the products and their delivery systems are so radically different it would be like trying to give up soft drinks by having a candy bar.

#5 monte cristo on 12.19.07 at 2:02 AM

Wow I tried the Frost Camel Snus – was pretty good – sure packed a nicotine punch but i wondered what i was going to do with the little pouch after i was done with it – i heard yesterday that the Lorillard Triumph will debut in OH and the top of the can has a little spitton for the old pouch – looks like the big three are all in the game – wonder why pm made their snus so weak from what i hear

#6 Patriot on 01.16.08 at 1:03 AM

As a veteran in the industry, I think retailers need to begin to champion the proper message as they market in their stores. They need to look at all of the efforts that the manufacturers are taking with restraints to salvage the industry! Retailers need to get the message out by the way they market to their consumers. I admire the efforts I see from a retailer like Sheetz who partnered with RJR with Camel Snus. Sheetz didn’t hide it they put it right on the sales counter which is what they needed to do to let the consumer know. Sure beats putting a lil debbie or lance product that sells for a quarter in the space.

So think we need to get the message out in whatever way we can! Great job to Sheetz.

#7 JD on 01.17.08 at 9:38 AM

Got a chance the other day to test Lorillard’s Triumph Snus and it is far superior to what PM is testing as snus. Testing begins this month and it will be interesting to see how this performs.

#8 fredmertz on 01.18.08 at 6:06 PM

Where are the Triumph test markets and does anyone have an idea what price point it will retail? How many snus packets to the tin and what shape and material are they using? JD can you answer some of these questions for me? Thanks.

#9 Steve on 01.22.08 at 12:00 AM

It’s my understanding that the test begins in Ohio the end of January . The product is in a round plastic tin with spitton on top. Like Catch & General from Swedish. Plain graphics on the tin. Sizeable potent pouches (24).

#10 Patriot on 02.20.08 at 11:36 PM

I was in Ohio over the weekend and I sought out the new product called Triumph. I found the container to be very user friendly with a spiton on the top which is what I found an issue with the Marlboro product (very weak) and the Camel Snus. I am glad that someone entertained the thought of what one was to do with the used product. The product was very tasty and strong. It was placed beautifully in it’s container. It had a serious lick and I can see folks using this product plus the caontainer had 24 pouches which was another plus. Great job Lorillard!

#11 Patriot on 02.20.08 at 11:38 PM

Opps – Triumph had a serious KICK!!!

#12 Samuel Garten on 03.26.08 at 10:50 AM

It’s unfortunate but what Dr. Brad Rodu tells us may not be the truth. The good dentist receives funding from United States Smokeless Tobacco (UST). He is first holder of the endowed chair in Tobacco Harm Reduction Research at the University of Louisville, School of Medicine. The endowed chair and accompanying research fund were created by tobacco companies; U.S. Smokeless Tobacco Co. and Swedish Match AB, who committed nearly $3.4 million.

Corporate financing (especially in regard to the tobacco industry) can have a settle effects on research and lead to unconscious bias. Studies have shown that sponsored research tends to reach conclusions that favor the sponsor. This is exactly what Dr. Rodu has done.

It has been pointed out that much of the research on the relative health impact of smokeless tobacco has been funded by the tobacco industry (Smokeless Tobacco Poses Challenge for Stop-Smoking Advocates, Join Together, 9/20/2006).

The use of tobacco in any form is bad and result in a decrease in quality of life and premature death.

#13 Cig Guy on 03.29.08 at 8:13 AM

SG – I thought Brad Rodu’s point was that Smokeless was a way to get off cigs to a lesser evil. Both have risk from what I have read but at a dramatically different ratio. I would pose that the opposite is true also that when an organization uses funds from the opposite side that the same type of findings would be skewed. Again in Brad’s defense there seems to be a magnitude of difference in the risk of smoking and dipping. I also question why no one questions the source of funding for the anti smoking movements. Seems to me that the big drug companies have a say here to promote use of their stop smoking products. Sam – would love to know your thought on Michael Siegels stance as it relates to the anti’s mis representation. Seems to me that the anti’s just outright mishandle the data to their advantage.

#14 Drew on 04.02.08 at 10:22 PM

They were giving away a free can with every cigarette purchase at I-75 and SR 613 in Ohio at the truck stop there (just south of North Baltimore). It was Triumph, original and Mint.

I snagged a can of the mint and I haven’t smoked a cigarette since. I was very worried that it would upset my stomach like all smokeless products, but nope, not a bit. Spitless and not a bit of stomach upset.

Looks like they are selling it too for 3.99 a can. A pouch lasts for a good 2 hours, they only say 30 minutes, but it’s far longer than that. Give it a try.

#15 John Rolfe on 04.03.08 at 1:06 PM

On the question of funding bias cited above, the principal reason that more people in tobacco control fail to stand up for public health — put on their public health hats as opposed to their tobacco control hats — is that they are afraid of losing their grant money and being kicked off of globallink and other tobacco control listservs. The UCSF control of the movement, as Siegel is wont to remind us, is making the extremists look increasingly absurd and while all can admit that no tobacco is the best solution, those in public health have come to realize (as opposed to those who continue to espouse quit or die denormalization), that smokeless is the lesser of two evils, something the FDA bill that passed Energy and Commerce completely fails to realize in the provisions dealing with health warnings. They also recognize that Pfizer and Glaxo Smithkline funding of tobacco control research and events biases the results since their goals consist uniquely in selling more NRT, which by the way is made with nicotine extract from tobacco.

#16 Johnie Jay on 04.03.08 at 11:25 PM

Drew – I’m curious as to what brand you smoke. In the recent RJR investor notes they found that 40% of the Camel Snus users was coming from the Marlboro cigarette user. Seems like folks are accepting the new products. I think it’s good to see all the new activity. How does the $3.99 price point compare to a pack of cigarettes in Ohio?

#17 Walter Raleigh on 04.09.08 at 12:27 AM

John Rolfe, I find your comments insightful but how then can those who truly understand the issues when both Swedish Match & USST just turned an about face on the FDA bill. And then NACS which has long turned its back on tobacco agree to support the legislation. It’s obvious they don’t understand the true issues.

#18 Robert on 04.16.08 at 3:33 PM

The good doctor has obviously never used smokeless. I have known chain smokers who have tried smokeless only to get light headed from their first few seconds of use. The kick is lots harder from smokeless that cigarettes. I have quit both, and believe me, smokeless was much harder.

Another thing the doc fails to point out is why use tobacco as harm reduction for tobacco? Why not use nicotine replacement products that are already on the market that have nicotine, but not all of the carcinogens in tobacco?

Get a clue Brad.

#19 Walter Raleigh on 05.17.08 at 2:42 AM

I saw Brad speak once and I think he is just given folks an alternative to cigarette smoking. He probably would agree with you Robert.

#20 Tom on 05.24.08 at 2:17 PM

Was on vacation and traveling thru Ohio last week and I bought a few cans of Triumph. I must say it was really good. I called a friend yesterday asking them to ship me some of the mint! Pretty neat no smoke but tobacco pleasure!

#21 Brave heart on 06.27.08 at 10:46 PM

Tried some Grand Prix Snus and it was much better than Marlboro and a lot cheaper. Love to try Triumph. Really like the satisfaction with no smoke.

#22 JLauren on 06.30.08 at 11:36 AM

I read an article that said SNUS is 90% safer than regular tobacco products because of the way it is processed. SNUS is pasteurized which kills most of the cancer causing microbes. If this is true – then this is a great alternative. I smoked and switched to SNUS and the transition was fine. I can even have a cigaratte from time to time when drinking and have no urge or desire to continue the next day.

#23 TAZ on 06.30.08 at 1:25 PM

JLauren,

Couple of questions?
How often to you use the product?
How long does the pouch last?
Is there a brand you favor?
Is there a flavor you like?
Anything you don’t like about the product?
Where are you finding the product?

#24 JLauren on 06.30.08 at 1:35 PM

I use it everyday. Probably go through about 4 cans a week (15 in each can). The pouch lasts anywhere from 20-45 minutes – depends on you really. My favorite brand is Camel, the original flavor, although Camel Frost and Spice taste good too. There is nothing I don’t like about the product really. I live in Ohio and there are a few places that carry it.

#25 Troubadour on 07.03.08 at 10:12 PM

JLauren

Have you tried the Triumph product made by Lorillard?Swedish Match. I have heard from some that it’s very good!

#26 JLauren on 07.10.08 at 7:10 AM

I have tried Triumph – it’s not bad – but Camel is much better.

#27 MONTE CRISTO on 07.13.08 at 3:08 PM

I hear that Camel has slowed up a bit. And industry numbers seem to indicate Triumph is growing in popularity. The packaging is better for Triumph and you also get 24 pinch packs where as Camel I believe is moving to 15 pp.

#28 JLauren on 07.14.08 at 1:25 PM

I would agree Triump is probably more popular – they are distributing those more widely. Camel still very has limited availability. They need to get off their butt. The couple places I buy Camel are sold out regularly.

#29 TAZ on 08.10.08 at 10:13 AM

Here is a portion of a writing by Michael Siegel on the blogroll – The Rest of the Story. He points out that the legislation will end up causing more deaths due to it not allowing for the development of new products of reduced harm.

The Rest of the Story

These are insightful and important observations about the likely impact of the proposed FDA tobacco legislation.

The key section of the bill is section 911, which sets out the criteria that need to be met before a reduced risk product can be introduced into the marketplace. According to this section:

“the Secretary shall approve an application for a modified risk tobacco product filed under this section only if the Secretary determines that the applicant has demonstrated that such product, as it is actually used by consumers, will–`(A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and `(B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.

Section 911(g)(1)(A), the (A) clause above places an insurmountable obstacle in the path of approval of modified risk products, at least for a 10-20 year period (which is enough to remove any incentive for companies to pursue such products). In order to demonstrate that the product, as actually used by consumers, will significantly reduce the risk of tobacco-related disease to individual users, large-scale, long-term epidemiologic studies are necessary. Even ignoring the requirement under 911(g)(1)(B), the (B) clause above (which itself appears to introduce an insurmountable obstacle), the bill as currently written precludes any harm reduction approach to tobacco control both by making it impossible for such products to meet the conditions for approval and by eliminating any incentive (especially economic) to develop such products. Thus, the bill may have the exact opposite effect that many believe it should have. It protects the existing high-risk products on the market.

Section 911 creates a literal catch-22 for reduced risk products. In order to introduce such a product into the market, you need to demonstrate that on an individual basis, it will reduce the risk of tobacco-related disease. However, in order to make such a demonstration, one would need to introduce the product into the market and follow a large sample of smokers for a long period of time – at least 10 years, if not longer. Thus, there is realistically no way to get a reduced risk product onto the market.

This legislation is likely to result in increased, not decreased deaths from tobacco products, because it will make it virtually impossible to research, develop, introduce, and market new potentially less hazardous tobacco products. It essentially freezes the market as it is and entrenches existing high-risk products into the market. It puts an end to any meaningful possibility of harm reduction as a tobacco control approach.

#30 George on 02.13.10 at 2:12 PM

In reference to Samuel Garten’s comments listed above…

Samuel Garten is just some anti-tobacco nazi who twists information in order to have a soapbox to yell from. More than half his articles contain incorrect information. We all know that tobacco is not good for you. Neither is more than half the food or drinks we consume.

In an article from 2009 this “doctor” claimed that a company online was exploiting children in Canada with their flavored cigars. When in fact, this “doctor” didn’t even look at the facts. He linked a cigar retailer (not the manufacturer) along with pictures stolen from a business website for his anti-tobacco agenda. That company does not make cigars and does not even ship to Canada! Its like blaming the gas station down the road for the pollution from car exhausts.
http://snus-news.blogspot.com/2009/05/canada-federal-governement-introduces.html

This is a perfect example of how these so called *professionals* work. A doctor who uses false information for a public diagnoses is a sure quack.

Keep up the good work Sam? Stay tuned for his study on Global warming…

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