CASAA Testimony on Dissolvable Tobacco Products mentioned in Wall Street Journal

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Vocalek

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Panel Requests More Data About Tobacco Lozenges - WSJ.com

Some see the product as an important alternative to cigarettes. Elaine Keller, representing the Consumer Advocates for Smoke-Free Alternatives Association, said cigarette-smoking adults are able to switch to less hazardous alternatives when they can't stop using nicotine completely. Ms. Keller, in FDA testimony, said her group doesn't have ties to the tobacco industry.

If producers want to market their product as a "modified risk" to cigarettes, there is a separate application. Star Scientific has submitted two products for this consideration.

To make recommendations on these topics the panel asked for more information about the way another smokeless tobacco product, a powder in a pouch called snus, has been marketed. They also requested a better definition of dissolvable tobacco, and whether products like snus should be included.
 

JustJulie

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Thanks for posting the excerpt, Elaine . . . you can't read the full article unless you're a paid subscriber to the WSJ.

Excellent quote!

For those who might not follow all of the legal and regulatory stuff too closely, this really is quite impressive for CASAA to have a speaker at TPSAC. :wub:
 

rothenbj

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To make recommendations on these topics the panel asked for more information about the way another smokeless tobacco product, a powder in a pouch called snus, has been marketed. They also requested a better definition of dissolvable tobacco, and whether products like snus should be included.

Now let me get this right. This panel has no idea what snus is? They don't know what it is or how it's used and they've done no research prior to these presentations? I'm having a hard time understanding this. You can sit at a computer and find all you need to know about the product including information on studies done in a matter of a few hours. To get a total education may take a few days, but it doesn't take long to find the difference between it and dissolvables and other smokeless products.

I'm well aware of the information because about a year and a half ago, when I was totally opposed to the use of smokeless products due to them being "more dangerous than smoking" and "spit tobacco", I did the research and within a few days my mind was changed and I was ready to order some from Sweden. Thank god for the internet. I guess this panel never got the memo from Gore about his new "invention" or perhaps it was lost when he invented global warning.

*almost forgot to mention* Elaine, I tried to get on to the presentations but it wouldn't load (probably my technology limitations) but I read your presentation slides and they were brilliant. Five star work!
 
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I'm well aware of the information because about a year and a half ago, when I was totally opposed to the use of smokeless products due to them being "more dangerous than smoking" and "spit tobacco", I did the research and within a few days my mind was changed and I was ready to order some from Sweden. Thank god for the internet. I guess this panel never got the memo from Gore about his new "invention" or perhaps it was lost when he invented global warning.

They don't need no "internets" to know what is best for tobacco users::matrix:
 

rolygate

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The most important thing to hide is that Sweden has the lowest rate of smoking-related mortality in the developed world. We must not let people hear this information - they don't need to know, and we know what's best for them. What's best for them is to keep paying taxes and keep our wonderful pharmaceutical and tobacco industries profitable. Individual rights do not matter in these tough economic times and when we are threatened by terrorists and are basically at war.

Stop arguing, it is not patriotic :)
 

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It's worse than you think, Roly. One of the other public speakers was our old friend, Gregory Connolly. He's the guy who published the "study" on the poisoning potential of new tobacco products in Pediatrics. Here is the NY Times coverage on it: Camel Orbs May Lure Young Users, Study Warns - NYTimes.com

Connolly displayed slides showing that the smoking rates have NOT been going down in Sweden or Norway in response to snus use. He said this is the largest and most recent study. No copies of his slides were provided (they may be posted later on the FDA site). So I can't tell you what study he was talking about. I have sent off an email to Dr. Rodu to ask what he knows about this.

So to recap, we don't just HIDE the fact that switching to snus results in better smoking cessation rates than the nicotine abstinence approach, we outright deny it.
 

Vocalek

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Now let me get this right. This panel has no idea what snus is? They don't know what it is or how it's used and they've done no research prior to these presentations? I'm having a hard time understanding this. You can sit at a computer and find all you need to know about the product including information on studies done in a matter of a few hours. To get a total education may take a few days, but it doesn't take long to find the difference between it and dissolvables and other smokeless products.

I'm well aware of the information because about a year and a half ago, when I was totally opposed to the use of smokeless products due to them being "more dangerous than smoking" and "spit tobacco", I did the research and within a few days my mind was changed and I was ready to order some from Sweden. Thank god for the internet. I guess this panel never got the memo from Gore about his new "invention" or perhaps it was lost when he invented global warning.

*almost forgot to mention* Elaine, I tried to get on to the presentations but it wouldn't load (probably my technology limitations) but I read your presentation slides and they were brilliant. Five star work!

The reporter didn't quite catch all the nuances. Most, if not all, the committee members know what snus is. They wanted more information on how snus has been marketed in Sweden and under what conditions, so that they could try to determine how that might play out in the U.S., where snus uptake is farily recent in comparison. When I say "under what conditions" I'm talking about the attitudes of the smokers, what knowledge they have of relative risks of products, etc. The reason they are asking about snus is because dissolvables are SO new that there are no long term data. They want to try to extrapolate what the effects might be in the U.S. on overall public health if dissolvables are promoted for "use when smoking isn't possible" as opposed to being marketed for "harm reduction." Actually, I see that as a positive step. They're thinking.

Oh, and thanks for the accolades. Your check is in the mail. :laugh:
 

rothenbj

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........They wanted more information on how snus has been marketed in Sweden and under what conditions, so that they could try to determine how that might play out in the U.S., where snus uptake is farily recent in comparison. When I say "under what conditions" I'm talking about the attitudes of the smokers, what knowledge they have of relative risks of products, etc.

Heck, they don't need that background, I can give them anecdotal information straight from the mouth of a long term smoker and US citizen. Smokeless tobacco is more dangerous than smoking, that's all I heard for decades. It's a disgusting, dirty, spit-ridden habit that will make your jaw fall off. That's the only message I received and anyone else over the last 30 years.

It will be a hard sell in the US unless the US decides to change directions and promote the truth. That's a hard sale on a number of fronts. First you need to spin the old story to get to the truth. Not too difficult if you are willing to throw all other smokeless tobacco, such as chew and dip, under the bus. I mean, it isn't "spit tobacco" now is it? Second, you need to take that big step and start admitting that tobacco in and of itself is not evil. Having moved from smoking is bad to tobacco and nicotine being bad, this is a very, very difficult change in direction and one that won't sit well with those attempting to corner the market in therapeutic nicotine. Third, how do you accept and promote snus (and any other tobacco/nicotine product that is seriously safer than smoking) and still manage to keep the tax revenue flowing to the various government bodies that are addicted to it. It's hard to justify the exorbitant taxes on cigarette sales being transferred to products that do not carry the supposed risk of cigarettes. Besides, I went from 2-3 packs a day, read tax dollars, to 4 or 5 portions of snus from a can of 24. I can go nearly a week on a product that I pay about the same as half of a pack of smokes. In my case they'd have to add over $50 in taxes to each can (which costs $3-4) to make up the revenue they lost on me each week. Hard realities.
 

rolygate

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Seems likely that someone there would doing the "Kids will get hooked on these" routine. Connolly was the designated propagandist for the day. They probably draw straws and agree who will go to which meeting. Not surprised he wouldn't sit next to you, he was worried he might catch it - sanity that is :). Fatal in his line of business, most likely. Or maybe the danger of second-hand vapor, of course (SHV).

As far as Snus goes, after so many years it could be that the user ceiling has been reached. For example if you consider e-cigs, and allow 40 years timelapse, the user uptake will go like a rocket at first, then slow down, then level off to a gentle climb, then finally stay as a static percentage when all those possible to convert have converted. At that point you'll have n% of smokers using e-cigs, and n% using tobacco cigs, the remaining hardcore who will not convert. Could be, after all this time, they have simply reached that point with Snus. It's interesting that it is about 20%, in that case. I would estimate a much higher figure for e-cigs. Also the head-to-head of Snus vs e-cigs in Sweden will be interesting.

A while back it was said that 40% of people in Sweden smoked, which was more or less a common figure across Europe, and 19% used Snus, 21% smoked. If that's what it still is then maybe they have reached the Snus uptake ceiling. 19% ain't a bad number though :)

Incidentally the 40% figure sounds way high, but there are different ways of measuring it. For example the UK official figure is around 20% (some days it's 19%, some days it's 23%, depending on whose stats you read). But we know that if all possible smokers are included then it jumps to a much higher figure, perhaps as high as 40%. The usual stats only include people who self-report as smokers, and at some sort of minimum daily level (I forget the amount). But if you include those who lied (possibly due to the report circumstances such as a doctor's or insurance questionnaire), and those who are occasional or 'social smokers' (people who only smoke when at the pub), then the numbers jump a considerable amount.

Does anyone know what the levels of carcinogens in dissolvables are, compared to other items like nicotine skin patches or Swedish Snus?
 
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rothenbj

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.........A while back it was said that 40% of people in Sweden smoked, which was more or less a common figure across Europe, and 19% used Snus, 21% smoked. If that's what it still is then maybe they have reached the Snus uptake ceiling. 19% ain't a bad number though :)......

Are you saying 40% of Swedes used tobacco, rather than smoked?

As far as the estimates of smokers, ex-smokers and non-smokers go, I don't think there is a realistic number anywhere. Most people don't understand that if you smoked more than 99 cigarettes in your lifetime you're classified as an ex-smoker epidemiology wise.

Dr Siegel had a blog entry (JULY 18, 2011) on nurses in Australia where it was reported that 35% of the Auckland District Health Board were smokers. I did some research and commented-

This is a very interesting development. According to the latest New Zealand Tobacco Use Survey, the nurses at Auckland's District Health Board, which employs more than 10,000 people, smoke at a rate of 167% of the national average.

Tobacco Use in New Zealand: Key Findings from the 2009 New Zealand Tobacco Use Survey

Now the question arises, among a population of well educated, health professionals, why would their smoking rates be so much higher than the general population. When you consider that the vast majority of smokers are from the poorer, uneducated portions of the population according to those that establish such numbers, there is little logic in these numbers, unless:

1. Smoking rates have not fallen at a rate that is identified by surveys.
2. Those surveying want to be able to show progress where no progress exists (need to keep funding the war).
3. Nurses better understand the relative risks and are therefore not as concerned as the rest of the population.
4. Nurse' job stress is so great that they are an anomoly.

Any guesses? Mine would be Anti propaganda of some sort. It seems so prevalent these days.

On further review, I found this 2006 report-

http://journal.nzma.org.nz/journal/121-1284/3310/content.pdf



"13% of female and 20% of male nurses were smokers. The highest smoking
prevalences were among psychiatric nurses (26% male and 30% female nurses).
There has been a steady decline in cigarette smoking among doctors and nurses in
New Zealand since the 1960s and 1970s."

Since only around 8% of nurses are men, the quoted % of nurses who smoke is probably closer to 13% than 20%, according to this report. Even at 15%, that 35% represents a 233% increase in smoking among nurses from Auckland's District Health Board to the general population of nurses in NZ. Something doesn't smell right.

"Conclusions The results from the 2006 Census demonstrate that non-smoking among
doctors and nurses is increasingly the norm, around 90% of younger doctors have
never been regular smokers. The results show that it is possible to achieve very
substantial decreases in smoking prevalences and to establish smokefree cultures
among substantial occupational groups who are well informed about the degree of
risk, are aware of the reality of the health consequences of smoking, and work in a
substantially non-smoking environment."


The only way it appears possible to level off these discrepancies appears to be a move to the next step after not hiring smokers (and smokeless tobacco users and NRTusers and E Cig users) is to introduce interventions into the existing staff. Then you probably can support the 2006 report's numbers.

The only issue I could see with that approach is a potential reduction in quality employees, but that's a small price to pay for the movement. Unless you're a patient that is.

I find myself looking around at various venues and on the street. Either there are a whole lot more smokers than get estimated or the non-smokers don't get out much.
 

rolygate

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The 40% figure is for all tobacco users / smokers, and apparently it was a general estimate of the average, real numbers of smokers / tobacco users across Europe at the time of this estimate (I'll have to look up the reference but it was in the last 20 years, not 50 years back when 'everyone smoked'. I used the word 'smokers' for 'tobacco users', possibly wrongly.

It is suggested that if people are totally honest, and if everyone is included who has smoked a cigarette in the last week or two, then the numbers jump - whatever country you are talking about - from the current 20% - 25% reported to a much larger figure.

The Swedish estimate used the real, honest number instead of the 'ideal' number that we use for the number of smokers. If all tobacco users are included, and all smokers / tobacco users are included who can qualify in any way, then the total was about 40% and 19% of those were Snus users.

Darnit, must find that ref...
 
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rolygate

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Well, surely we all know that nurses have the highest numbers of smokers and chocolate eaters of any population group? An impromptu survey of acquaintances by the Roly market research organisation, plus half-remembered data from the past (= fond memories), tells us that 93% of female medical staff are regular chocolate eaters and 42% are smokers. In fact, if you are talking to a chocolate-eating smoker, there is a 79% chance you are talking to a nurse (or a psychiatrist). Actually I fabricated those numbers but they are in the ballpark :)

We can immediately identify a nurse's car because they have full ashtrays and the floor is covered with candy wrappers. Car mechanics need to know this as they can then diagnose that the oil (if any remains) has not been checked for the last 60,000 miles.
 

rolygate

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OK, it's back to the facts, ma'am. Here we are:

1. Should the European Union lift the ban on Snus? Evidence from the Swedish experience
Fagerström, Schildt, 2003.
Should the European Union lift the ban on snus? Ev... [Addiction. 2003] - PubMed result

This is an opinion piece but written by researchers responsible for several papers published on Snus. The exact numbers they state for Sweden are:
17% of men smoke
19% of men use Snus
1% of women use Snus

This appears to total 37% but does not include female smokers. It also appears to be the 'honest' total of smokers, that is, all/any who smoked a cigarette within the last month. I believe this is a very different figure from the version you get if you ask people to self-report, and only include those who are daily smokers. However dual use may be involved.

2. Smoking - Occurrence. In: EUPHIX, EUphact - EU Public Health Information System
Kaiser, Gommer (RIVM), 2008.
Smoking : Smoking - Occurrence - EUphact

"The proportion of those aged 15 years and over who smoke in the EU-27 ranges from 16% in Sweden to 38% in Greece. Despite wide variations in smoking prevalence among member states, the overall average for the 27 EU member states is roughly the same as it was before the EU was enlarged in 2004 and 2007."

"Comparisons are confounded by differences in definitions and data collection.
Most countries estimate the percentage of adult smokers on the basis of health interview surveys, which can yield variable data. Variances can, for example, be caused by differences in the way a 'smoker' is defined. For some countries 'smoker' implies a 'daily smoker', for other countries it means a 'regular smoker' and for still other countries it equates to 'all smokers' (which would include occasional smokers). Likewise, for ages defined as 'adult' or '15 years and over' the lower age limit may range from 13 to 20 years and the upper age limit may range from 64 to 84 years. Moreover, population samples are not always representative of the whole country. International comparisons must therefore be made with caution.
Additionally, different international databases may show different data from the same country."

"In general, smoking prevalence is higher among men than women. In six countries, this difference is more than two-fold: Cyprus, Romania, Portugal and the three Baltic states. In the UK, Ireland and Slovenia, the rates are about equal for both sexes.
Trends over the past decades show that the differences in smoking prevalence between men and women are declining.
In Sweden, the smoking prevalence among women is higher than among men."

"The tobacco epidemic in the EU is evolving.
The term 'Tobacco epidemic' refers to a particular global pattern that is visible for tobacco consumption. This started with a peak in smoking behaviour among men, followed by a peak in women, and then related mortality peaks several decades later. The tobacco epidemic has reached different stages in different European countries (see The tobacco epidemic).
Some European countries are in stage four of the tobacco epidemic - such as Denmark, Germany, Finland and the UK. Germany, for example, shows a decrease in total, male and female prevalence of smoking between 2000 and 2003, while Belgium recorded a drop in overall prevalence, which was, however, mainly due to the decrease of smoking in the male population between 2000 and 2002.
In central and eastern European countries there was little awareness of the harmful effects of tobacco smoking until the late 1980s. These countries, as well as some southern European countries are now at stage three of the epidemic, with smoking prevalence among males peaking or just beginning to decline, and smoking prevalence among women still increasing."

Roly says:
"The global tax epidemic seems to be on the decline, due to the slow but accelerating uptake of Snus and especially electronic cigarettes. This epidemic is characterised by the availability of large amounts of tax revenue from the sums levied on smokers, which are approximately ten times the burden of cost due to smoking. These vast sums encourage governments to engage in utter profligacy, in the belief that such huge reserves of cash will always exist and that tomorrow never comes. The North Sea oil ran out and so will the massive sums generated by the sin tax on tobacco when smokers are finally told the truth and move en masse to safer tobacco alternatives."

This statement appeared in no peer-reviewed journal and will probably never see the light of day.


3. Euractiv: Fewer smokers in EU
Fewer smokers in EU | EurActiv

Some of this data directly contradicts that in the other EU report. This one bears all the hallmarks of spin.

"The survey seems encouraging for the EU's anti-smoking campaign For a Life without Tobacco (HELP), launched in March 2005, as the results show that the number of smokers has fallen by 6%, from 33% in 2002 to 27% in 2005 and that the number of people who have given up smoking has risen by 3%."

4. Euphix stats 2007
Percentage of daily smokers aged 15+ in the EU-27 (source: WHO-HFA, 2007).
Smoking : Percentage of daily smokers age 15+ in the EU-27 - EUphact

Sweden (2005) 13.9 (male) 18 (female) 15.9 (total)
UK (2004) 26 (male) 23 (female) 25 (total)

The number of male and female smokers appears to be combined then averaged. I suppose this holds good if the male and female population are equal; or perhaps the numbers are adjusted.

The number of smokers in Sweden seems to be falling, it is by far the lowest in Europe.

5. European Public Health Alliance - 2004 (?)
*UPDATED* European smoking bans - Evolution of the legislation - European Public Health Alliance

"With more than 40% of its population smoking, Greece is the EU country with the highest rate of tobacco consumption."

6. Health EU
Tobacco

"Despite considerable progress, the number of smokers in the EU is still high – around one third of the population."

7. Europa EU
World No Tobacco Day – Survey reveals drop in smokers in EU
EUROPA - Press Releases - World No Tobacco Day

"The percentage of people smoking in the EU was 33% in 2002, and 27% in 2005."

This is from spin central, though, so has to be taken with a grain of salt.

8. Velvet Glove, Iron Fist
Velvet Glove, Iron Fist: Smoking bans in Europe

"All of which will mean that of the 27 EU states, only 2 - the UK and Ireland - will have a total smoking ban."

This piece is an explanation of details that show in actual fact only the UK and Ireland have real smoking bans.
[OK this has nothing to do with anything, I just thought it was interesting :) ]

9. Smoking - Summary. In: EUPHIX, EUphact.
Smoking : Smoking - Summary - EUphact

"Success of interventions geared at smoking behaviour will determine the future health of the EU population.
Collective interventions, such as anti-smoking campaigns raise awareness of the adverse effects of smoking, induce individual cessation efforts, and prevent young people from taking up smoking.
Individual interventions, such as pharmacological and behavioural therapies, significantly increase the probability of long term smoking cessation. They are highly cost-effective and when combined with collective interventions prove to be even more effective."

I included this because there is an outright lie here that indicates the massive self-delusion that underpins the the tobacco control industry. These 'pharmacological interventions' are not 'highly cost-effective', in fact they are a monumental failure and an obscene expense that can only be driven by either financial corruption or job security corruption. A success rate of 35% may look impressive at 4 weeks but when the real figure is revealed as a 2% success at 20 months, it doesn't look like value for money. In fact it's a diabolical scam, and since it can only be based on some form of corruption, it is fraud.

---------------
So here are some EU stats in all their inconsistent, massaged and spun or alternatively raw glory. Make of them what you will. As no EU statistics agree anywhere then you can probably draw whatever conclusions you like from them. Some of the tobacco control people certainly do.
 
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rothenbj

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Roly, that was an excellent summary of the nature of smoking statistics.

Individual interventions, such as pharmacological and behavioural therapies, significantly increase the probability of long term smoking cessation. They are highly cost-effective and when combined with collective interventions prove to be even more effective."

The above statement truly points out the psychological imbalance in these people, to the point of delusional. I believe there is therapy for this condition and I know there are pills on the market.
 

Vocalek

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Wow, Roly. You are a font of information!

Now that you mention it, I now recall that Connolly said, "Smoker being defined as anyone who smoked at least 1 cigarette during the past 30 days." And I said, soto voce, "That's not a smoker."

The statisticians need to settle on one definition, and that definition needs to be "daily smoker." His definition is like defining "alcoholic" as anyone who has had at least one drink during the past 30 days.
 

Vocalek

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Roly, that was an excellent summary of the nature of smoking statistics.



The above statement truly points out the psychological imbalance in these people, to the point of delusional. I believe there is therapy for this condition and I know there are pills on the market.

Speaking of pills, I have finally figured out why there are no nicotine pills to treat us fiends. The explanation came from the Star Scientific people who addressed the (lack of) poisoning danger from their orbs product in the TPSAC meeting. Once you swallow the nicotine, your stomach says "No way, Jose" and sends it right back out the way it came in.

You would think that a brilliant Pediatrician and a Harvard Med School Professor would know these little medical details.

:sneaky: <- could not find a "sarcasm" icon, so this will have to do.
 

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I find myself looking around at various venues and on the street. Either there are a whole lot more smokers than get estimated or the non-smokers don't get out much.

I was a the pub the other day, and literally 100% of the customers had a pack of smokes in front of them and was going outside every little while. I sat there comfortably vaping, and thinking to myself... So much for the non-smokers going to the pub in droves once smoking was banned from them!
 

Vocalek

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I received a response from Dr. Rodu:

Elaine,

Thanks for your note. I saw the webcast on dissolvables. Your presentation was outstanding. In fact, it was so impressive that TPSAC members were left speechless ;).

With respect to Sweden and Norway, I have no idea which study Connolly was describing. Of course, it is possible to present data in a way that obscures the effect of snus use on smoking, but an unbiased evaluation of available information comes to only one conclusion: snus use has impacted smoking and smoking-related mortality for 50 years. TPSAC members always referred to the Swedish experience as "debatable" or "controversial," which is reminiscent of cigarette manufacturers denial of cigarette-related mortality. And published studies by Karl Erik Lund have demonstrated that the Swedish experience is being replicated in Norway.

For a summary of published studies about the Swedish experience until 2006, take a look at the review by Rodu and Godshall in Harm Reduction Journal, HRJ | Full text | Tobacco harm reduction: an alternative cessation strategy for inveterate smokers (See Section C.3 The Swedish tobacco experience). I have just completed a new review of published studies from 2006 to 2011; it will be published soon in the same journal. For a very simple comparison of Sweden with the rest of the EU, take a look at the attached manuscript.

The poisoning scare from Connolly and Winickoff is ridiculous, as I pointed out last year (Tobacco Truth: Poisoning Public Health Issues including your comment).

Brad
 
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