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...Providing the whole story behind tobacco news.

Friday, July 10, 2009

American Cancer Society Continues Efforts to Ban Electronic Cigarettes, While Giving the OK to Conventional Ones

The idiocy of the American Cancer Society's position on tobacco products continues to be apparent as the organization pursues the elimination of electronic cigarettes from the market at the same time it applauds the special protection for the existing, more hazardous ones.

In an article in the Staten Island Advance, a regional vice president of the Staten Island American Cancer Society was quoted as calling on the removal of electronic cigarettes from the market because: "These devices haven't been examined by any government agency. We don't know how the ingredients are affecting the body."

The Rest of the Story

Well we know how the more than 10,000 chemicals in conventional cigarettes are affecting the body and have thoroughly examined that product and the results are not good. Are you telling me that the American Cancer Society would rather that smokers continue smoking those conventional cigarettes than that they switch over to electronic cigarettes, which we know are safer?

It doesn't take examination by a government agency to determine that electronic cigarettes, which deliver nicotine and some propylene glycol, are going to be safer than regular cigarettes, which deliver nicotine plus 10,000 chemicals, including more than 60 carcinogens.

But while the American Cancer Society wants to immediately remove the safer alternative to cigarettes from the market, it wants to keep the regular ones on the market and provide them with special protection by eliminating the ability of the FDA to take any action that could seriously reduce their use, such as raising the age of sale of tobacco, regulating the places where cigarettes are sold, or getting rid of the nicotine.

Is the American Cancer Society trying to get rid of cancer, or promote it? By its absurd policy positions, you'd be hard pressed to come up with the right answer.

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Thursday, July 09, 2009

The Second Hoax of the FDA Tobacco Legislation: Consumers Will Now Know What is in the Smoke that They are Inhaling

A huge benefit of the FDA tobacco legislation, according to the Campaign for Tobacco-Free Kids and other health groups which supported the bill, is that it requires tobacco companies to disclose to the FDA "all smoke constituents."

The major summary of the FDA tobacco bill by the Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, and American Lung Association claims that the legislation will require the tobacco companies to "disclose to the FDA the ingredients in each existing tobacco product by brand and by quantity in each brand, including all smoke constituents." These groups boast that because of the enactment of the legislation, consumers will now be informed of "the constituents of tobacco smoke that result from burning the product."

Furthermore, these groups claim that because we will now know the constituents of the smoke, the FDA will be able to mandate a safer cigarette by requiring the reduction or elimination of certain of these smoke constituents. And because of these mandated changes, the legislation is going to "save countless lives."

The Rest of the Story

Once again, the health groups have been lying to their constituents and the American public about the legislation and have been effectively covering up what I call the "second scam" in the legislation: the propaganda that consumers are now going to be informed of all the chemical constituents in the tobacco smoke they are inhaling and that tobacco companies are now required to disclose all the constituents of the tobacco smoke produced by their products.

Nothing could be further from the truth. This bill does not, and cannot, require tobacco companies to inform consumers of all constituents in tobacco smoke.

Why? The reason is very simple. Nobody knows all the constituents in tobacco smoke. Not even the tobacco companies themselves. In fact, we don't even know half of the constituents in the smoke. Less than half of the chemicals in tobacco smoke have been identified, and the remainder will probably never be identified.

Moreover, we don't even know, within one order of magnitude, how many chemicals there even are in tobacco smoke which would need to be identified in order for consumers to know what they are inhaling, as the health groups claim will now be the case.

It is fairly well recognized that there are approximately 4,000 identified chemicals in tobacco smoke. It is also the case that, based on gas chromatographic, mass spectrometric, and nuclear magnetic resonance imaging evidence, there are probably between 10,000 and 100,000 chemical constituents in tobacco smoke. This means that at a maximum, only 40% of the smoke constituents have even been identified, and at a minimum, we might only have identified 4% of these chemicals.

Can you imagine the Campaign for Tobacco-Free Kids supporting a bill that would require the manufacturers of electronic cigarettes to disclose 4% of the constituents of the vapor produced by those products? And can you imagine the Campaign then boasting to the American public that the legislation has forced the e-cig manufacturers to disclose all the constituents of the vapor?

The public would immediately accuse the Campaign of lying to them and deceiving them. And in fact, that is exactly what the Campaign is doing with regards to conventional cigarettes.

At best, the FDA legislation requires the tobacco companies to disclose 40% of the chemicals in tobacco smoke, and at worst, they are forced to disclose 4% of these chemicals. If the Campaign for Tobacco-Free Kids and other health groups were honest, their propaganda would not state that the companies are required to disclose all the constituents of tobacco smoke. It would state that the legislation requires the tobacco companies to disclose between 4% and 40% of these chemicals.

Moreover, the disclosure of these chemicals is nothing new. A comprehensive list of these chemicals has already been published and anyone who is interested can buy the book on Amazon.com for $268.86. This represents a 10% savings over the list price of the book. But you have to act now! Not only this, but the book ships free with super saver shipping. There were only 2 left in stock at the time this blog post went to press, but many more are on the way.

Perhaps most importantly, the truth being revealed here today exposes how absurd it is to claim that the FDA will be able to mandate a safer cigarette by removing some of the 4,000 known constituents. Even if all the 4,000 known constituents were removed, there would still be as many as 96,000 unknown constituents, and we would really not be able to claim that the resulting product is safer. At least not until it was tested by human guinea pigs. This is exactly what the FDA legislation does. It asks the FDA to use smokers as guinea pigs. It asks FDA to fraudulently deceive smokers into thinking the product "safety" standards being promulgated by the FDA will result in a safer cigarette without definitive evidence that this is true. Essentially, it transfers the fraud previously being committed by the tobacco companies over to the federal government.

The ultimate absurdity of the legislation is the very thought that there is any useful information for the consumer in receiving a list of the 4% of smoke constituents that have been identified. As if the consumer understands what it means that cigarette smoke contains only alkanes below the n-C32 alkane or that it is somehow meaningful for the consumer to understand that 48% of an alkene-free alkane fraction of mainstream smoke consists of n-hentriacontane, n-dotriacontane, and n-tritriacontane.

Personally, I think the revelation that cigarette smoke contains n-dotriacontane is going to be earth shattering. After hearing this shocking news, I predict that no smoker will ever pick up another cigarette in his or her life.

You know, when it was only known by smokers that they were inhaling n-hentriacontane and n-tritriacontane, smoking rates were really high. But now that smokers are going to find out that there is also n-dotriacontane in there, I think smoking rates are going to plummet.

I wonder how specific cigarette companies are going to have to be in reporting the smoke constituents. Will it be enough for them to inform the FDA that there is acetic acid in tobacco smoke. Or will they have to be more specific and disclose that actually, there is the 2-oxopropyl ester, the pentyl ester, and the dreaded 2-pentyl-3-oxo-1-cyclopentyl-methyl ester present (not dreaded by smokers of course, but dreaded by organic chemistry students throughout the nation).

Frankly, I think disclosing that cigarette smoke contains the 2-pentyl-3-oxo-1-cyclopentyl-methyl ester of acetic acid has to be one of the greatest public health achievements of our lifetime. That disclosure alone is certainly going to save countless lives.

Of course, I guess we must also consider the possibility that finding out some of the constituents in tobacco smoke might actually increase the incentive for smokers to smoke. For example, they are unfortunately now going to find out that tobacco smoke contains alanine, an amino acid which is essential in protein formation and essential for life. It also contains the essential amino acids arginine and aspartic acid, and we're only on the A's.

We all knew that cigarette smoke contained benzene, but it will now become evident to previously ignorant smokers that the smoke they are inhaling actually contains 152 different variants and sub-types of benzene. That is sure to give any smoker pause before taking their next drag.

Speaking of the B's, there is some good news for smokers. Tobacco smoke contains bismuth. Maybe that's why a good smoke after a meal is so comforting - it may actually help prevent indigestion. Beware when smokers find this out. It could undo years of public health education about the hazards of tobacco products.

The really bad news for public health advocates is that smokers are now going to find out that tobacco smoke contains beta-carotene, a precursor to vitamin A. Uh oh. Tobacco smoke contains vitamins? This is bad news. All we need is smokers finding out that their Marlboros are providing them with a percentage of the U.S. FDA recommended dose of vitamin A.

And the beauty of the whole thing is this: smokers can get their FDA recommended dose of vitamin A by smoking FDA-approved cigarettes!

There are over 120 forms of DNA in cigarette smoke. That is going to be a shocker for most smokers. Hey, do you think different brands of cigarettes have different DNA fingerprints?

Another piece of good news is that smokers will find out that cigarette smoke contains ethanol. This could drive down rates of alcohol use, as smokers will now understand that they don't need to drink while having a smoke: the alcohol is already provided by the cigarette companies for their enjoyment!

There's gold in tobacco smoke! This is not only good news for arthritic smokers, but it actually validates the "Marlboro Gold" brand name. They're not just whistling dixie!

Don't make this public yet, but smokers throughout the country are soon going to find out that tobacco smoke is a source of iron. So with your FDA-approved cigarettes first thing in the morning, you can get a good start on your FDA-recommended doses of both vitamin A and iron. And throw calcium in there as well. Why not, with all these hidden surprises about the nutrients present in tobacco smoke that no smoker ever knew about before.

When smokers find out that tobacco smoke contains nitrous oxide, will they start smoking just outside their dentist's offices to get a head start on the laughing gas? Maybe it averts the need for laughing gas in smoking patients.

Knowing how concerned the health groups are about smokers being properly informed about the constituents in tobacco products, I wonder whether these groups are going to call on the FDA to require cigarette companies to furnish consumers with "octane levels" for their cigarettes. Soon, you're going to see Newport Regulars, Newport Mid-Grades, and Newport Premiums. And we won't be able to sue Lorillard for misleading consumers, because there is octane in their products. Smokers are going to have a difficult decision between whether to go with the cheaper low-octane yields or spend a bit more for a more energy-efficient cigarette.

Since tobacco smoke contains phenylalanine, I suppose the FDA should require a boxed warning on cigarettes advising people with phenylketonuria to avoid the product.

Now here's the dinger. Tobacco smoke contains 37 different types of protein. I can see it now: Philip Morris will come out with a new Marlboro campaign based on the accurate claim -- Marlboro is FDA approved and provides you with a variety of nutrients, including vitamin A, calcium, and 37 different types of protein. The tobacco companies can now compete with Baskin Robbin and its 32 flavors by boasting 37 different types of protein.

Let's just keep it between you and me that tobacco smoke contains vitamin B2, which has a critical role in maintaining health in humans.

The rest of the story is that I think we all owe a debt of gratitude to the Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, and American Lung Association. The revelation of the known constituents of tobacco smoke has to go down as one of the most useful and earth-shattering public health achievements of the 21st century. Smoking rates should start to plummet immediately, the FDA will know all the chemicals it needs to get rid of to mandate a safer cigarette, and we are going to save countless lives.

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Wednesday, July 08, 2009

Pharmaceutical Money-Related Bias in Smoking Cessation Research is Now Readily Apparent; New Article Demonstrates How This Bias Pushes Medication

An article published in the current issue of Nicotine and Tobacco Research concludes that spontaneous quit attempts are more than twice as likely to be successful as planned quit attempts (see: Ferguson SG, Shiffman S, Gitchell JG, Sembower MA, West R. Unplanned quit attempts -- results from a U.S. sample of smokers and ex-smokers. Nicotine and Tobacco Research 2009; 11:827-832).

An online survey was conducted with 900 current smokers and 800 ex-smokers. The odds of a spontaneous quit attempt being successful (defined as lasting longer than 6 months) were found to be about 2.6 times greater than the odds of a planned quit attempt being successful. The paper also found that, as expected, planned quit attempts were much more likely to involve the use of pharmacotherapy than unplanned quit attempts.

Thus, these results support the conclusion that cold turkey cessation remains the most effective means of quitting smoking. Cessation attempts that involve pharmacotherapy are substantially less likely to be successful than quit attempts that do not involve the use of pharmacotherapy.

Of course, these findings are in direct contradiction to the recommendations of a national panel of smoking cessation experts, which recommends that pharmacotherapy be used in every quit attempt.

Interestingly, although the authors find that the use of pharmacotherapy is not particularly effective in smoking cessation on a population level, their major conclusion from the study is as follows: "The results suggest, similar to previous research, that a substantial proportion of quit attempts are unplanned and that such attempts can be a successful route to cessation. Given the frequency of such attempts, methods of making treatment available to assist unplanned quitting should be considered."

The Rest of the Story

When I read this paper, I found the conclusion particularly odd. The findings of the study were that planned quit attempts are not the way to go, and that the use of pharmacotherapy is not particularly effective on a population level. The study confirmed previous evidence that unplanned quit attempts are more successful, probably because they involve a much higher level of motivation. But the major conclusion of the study was that methods of making pharmacotherapy available to those making unplanned quit attempts be developed.

I teach my students that in a scientific manuscript, the conclusion of the paper should follow directly from the study findings. And the conclusion should not be one that could have been made in the absence of the study findings. In other words, the conclusion should be directly related to the study findings.

In this case, the conclusion has no direct relationship to the study findings. It does not follow at all from the findings. Those findings do nothing to support the conclusion. In fact, if anything, the study findings are at odds with the conclusion.

The assertion that pharmaceuticals be made available to smokers making spontaneous quit attempts is one which is based on a particular opinion, not one that is based on any specific findings of this study. In fact, such a conclusion could have been asserted prior to even beginning the study. This research did not even test the effectiveness of the use of pharmacotherapy in unplanned quit attempts. There is no evidence presented that pharmacotherapy would be effective in aiding such quit attempts. In fact, it is perfectly plausible that pharmacotherapy would hinder such quit attempts as it would keep the smoker addicted to nicotine while a large proportion of these smokers are getting themselves off of nicotine entirely.

This conclusion seemed quite mystifying to me until I read the fine print at the end of the paper.

The following information is revealed:

1. "This study was funded by GlaxoSmithKline Consumer Healthcare."

2. "Through their work at PinneyAssociates, Dr. Ferguson, Mr. Gitchell, Dr. Shiffman, and Mr. Sembower serve as consultants to GlaxoSmithKline Consumer Healthcare on an exclusive basis
on matters relating to smoking cessation. Dr. Shiffman and Mr. Gitchell also have an interest in a venture to develop a new nicotine replacement medication. Dr. West undertakes research and consultancy for manufacturers of cessation medications and has a share of a patent in a novel nicotine delivery device."

Aha! We suddenly have an explanation for the very odd, contradictory, and out of place conclusion of this study. The pharmaceutical funding of the study and of its authors has created an exceptionally strong bias that is leading to the study pushing drugs when it should probably be doing just the opposite: pushing cold turkey quit attempts without the use of pharmacotherapy.

This is an excellent example of the way in which financial conflicts of interest create significant bias in scientific studies and lead to biased conclusions that do not fairly and objectively present and interpret the scientific findings of a particular study and the overall literature on the topic. The bias is most readily apparent in the recommendations that are made in the study, which do not follow directly from the study findings, but instead, serve the interests of the study sponsor and the financial interests of the investigators.

I want to make it clear that this is no minor issue. It has substantial public health implications. I believe that the obsession with pharmaceuticals is severely hindering the tobacco control movement and the effort to enhance smoking cessation in the population. My own work and experience and that presented in the published literature support the conclusion that the most effective way to enhance smoking cessation is to put resources into aggressive anti-smoking media campaigns that give smokers a major jolt and spur them to make spontaneous quit attempts. The California anti-tobacco media campaign in particular has been documented to have produced exactly such an effect.

But instead of providing further support for the implementation of such interventions, this study is basically trying to support the status quo by merely suggesting that pharmacotherapy be made available to those making spontaneous quit attempts. To be honest, I believe that such an intervention could well do more harm than good. More importantly, to focus on the pharmacotherapy aspect of the intervention takes the attention from where it needs to be: on the need for more aggressive efforts to try to create the motivation necessary for smokers to accomplish the Herculean task of quitting smoking, as demonstrated beautifully in this study.

In some ways, that's the shame of the whole situation. Here is what I consider to be a beautifully conducted, insightful study that brilliantly examines a major research question and makes a huge and rather earth-shaking contribution to the existing literature on smoking cessation. However, what is the conclusion that comes from the study? Merely that the products made by a company with which the authors have a financial conflict of interest be marketed to the smokers who are currently having the most success without pharmaceuticals.

God forbid that a smoker succeeds in quitting without providing profits to Big Pharma, is essentially what this study is concluding.

I don't believe we're that far from a rational and science-based policy regarding the promotion of smoking cessation in this country. But the one thing which is keeping us from getting there is the prostitution of the tobacco control movement to pharmaceutical company financial interests.

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Tuesday, July 07, 2009

Anti-Smoking Researcher Accuses Rest of the Story Author of Slander; Writes to Dean in Attempt to Have Me Reprimanded and Stifled

The author of a paper which I criticized in a May 28 blog post has written a letter of complaint to the dean of my school, accusing me of slander and seeking that action be taken against me for such slander.

The letter states as follows:

“I am writing to you today to file a formal complaint concerning one of your faculty members, Michael Siegal. As you may know, Dr. Siegal regularly posts blogs on the internet that are critical of tobacco control research. Dr. Siegal was once a respected member of the tobacco control community, and I served with him on the board of the Tobacco Control Research Center. In recent years, Dr. Siegal’s critiques have become quite offensive to others in the field of tobacco control. He has alienated his former colleagues in droves, and as a result he has been banned from participation in tobacco control listserves, and to my knowledge, no longer serves on the boards of any tobacco control organizations.”

“Today, Dr. Siegal posted a blog concerning a study I had published in BMC Public Health concerning youth access to tobacco. I feel Dr. Siegal has slandered me by impugning my reputation as an honest academic researcher. Honest and respectful scientific debate is always welcome, but this blog was anything but. To make his point, Dr. Siegal misrepresents important details about my study, and makes a number of assertions about the current state of our knowledge that have no basis in fact. As a result, readers are misinformed regarding scientific facts and are led to conclude that my study is critically flawed. Through factual misrepresentations, Dr. Siegal misleads his readers regarding the value of my work. I assume that deceiving the public is not part of the mission statement for the School of Public Health.”

“It is one thing for Dr. Siegal to express his own bias and to be academically sloppy, but he goes beyond that by inserting several innuendos to imply that the study has a hidden bias. He states that we have ‘no objectivity’ and ‘no credibility.’” …

“I am writing at this time because this is not an isolated incident. I have been his victim before and from his postings I have observed that other academics are also dealt the same abuse on a regular basis. Even his format in which he presents the researchers’ words and then responds with “The Real Story,” implies that the authors of the original research are being dishonest. One can disagree with another researcher without slandering his or her character.”

The Rest of the Story

This story is an important one, because it is illustrative of the type of thinking that has come to permeate the tobacco control movement. You simply cannot criticize a tobacco control study. Even if you are a distinguished professor in the field. By doing so, you are committing slander. It doesn’t matter whether you are telling the truth or not. It doesn’t matter how well your opinions are supported. What matters is that you are being critical of tobacco control research, and that is simply not allowed in the movement. Criticism is tantamount to slander. It is offensive to your tobacco control colleagues and alienating. It will get you kicked off listserves and make you ineligible for leadership positions in tobacco control.

Before discussing the substance of the complaint, I want to highlight what this means for the tobacco control movement. What it means is that any dissent is stifled. If researchers are led to believe that any criticism of published scientific articles in tobacco control is slanderous and offensive, will lead to complaints to your dean, and will lead to your expulsion from listserves and ineligibility to participate on the boards of tobacco control organizations, then logically, researchers are going to keep quiet about studies with whose conclusions they disagree.

This is exactly how crappy science – like that behind the Helena et al. conclusions – comes to be accepted as dogma, without public challenge. It is not that the science is solid. It is simply that anyone who criticizes the science is going to be viewed as a traitor, a slanderer, an offensive former colleague.

To use the term “scientific McCarthyism” really doesn’t seem all that inappropriate here. In fact, it seems to fit the situation quite well.

An even better analogy might be to a religious movement. The tenets of the religion represent dogma which cannot be challenged. Anyone who does is a heretic and must be cast out from the movement.

This is the way in which the tobacco control movement can be kept “pure” and devoid of any challenge to its doctrines. It ensures that dogma will never be seriously challenged, that the ways of the past will always continue, and that the extremist elements of the movement will be able to assert and maintain control.

But as all good scientists understand, this is a pure recipe for scientific disaster, because the very process of good science is one which relies upon the constant challenging of existing ideas and dogma. A movement in which scientific articles are not subject to criticism is one in which science can no longer flourish.

This threat to the strength and integrity of the science in tobacco control and public health, and not the fact that I am being personally attacked without justification, is what troubles me about this episode.

Now to the substance of the compliant. The researcher accuses me of slander. This means that he is alleging that I have lied about him, that I have recklessly disregarded the truth in an intentional attempt to discredit him and malign his character.

In order to make such an allegation in a letter to my dean, I would expect that the letter should specify exactly what matter of fact I have lied about or misrepresented. However, the letter fails to specify any factual matter about which I have lied or which I have misrepresented.

Thus, the letter is accusing me of slander - a most serious offense - without providing any evidence whatsoever that I misrepresented factual information.

The truth is that my commentary was simply a criticism of the study, published in BMC Public Health, which concluded that enforcement of youth access laws result in a substantial reduction in youth smoking. The paper was based on a cross-sectional study which found a correlation between the presence of more rigorous enforcement of youth access laws and lower youth smoking rates. But as I explain in my commentary, correlation does not equal causation. It is also possible that the lower youth smoking rates preceded the strong enforcement of youth access laws. In other words, it may be that towns with lower youth smoking rates also have greater anti-smoking sentiment, and this anti-smoking sentiment may lead to intensive enforcement activity.

My other criticism of the study is that it presented a very biased review of the existing literature on the topic of youth access laws. In particular, it failed to even mention a meta-analysis which showed that these laws have no effect.

But apparently it is not allowable in tobacco control to criticize a study on such grounds. Criticism equals slander.

Interestingly, the letter itself presents misinformation of fact in order to try to make its point. The letter states that my blog is entitled "The Real Story." The letter suggests that by using the phrase "the real story," I am suggesting that the study under discussion is false and the researchers are dishonest. The truth, of course, is that this blog is called "The Rest of the Story," by which I am only trying to imply that I have a perspective to add that may be different from what was presented in the study and in the media coverage of it.

To be clear, I made no assertion that the researchers in question were dishonest in any way. Bias does not mean dishonesty. It also doesn't imply any wrongdoing whatsoever. A researcher can be perfectly honest and perfectly proper and appropriate in his work, yet still be biased in his presentation of findings or conclusions.

The letter actually goes so far as to suggest that because I opine that the study's presentation of the existing literature is biased, I am guilty of slander. Of course, my views on whether there is or is not bias in any particular study is merely an opinion, and so expressing that opinion is not and cannot be slander.

The reality is that all research is biased to some extent. So if you are not allowed to suggest that a particular piece of research is biased, you are not free to comment on any research. It appears that is exactly what is desired in the tobacco control movement. The scientific literature in tobacco control should be immune from criticism. It is apparently like a sacred text: its validity cannot be challenged.

This episode is important because it demonstrates the current mentality in the anti-smoking movement. There is really no room for dissent or criticism of tobacco control science and if you do dare to criticize, you are putting your career in jeopardy.

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Monday, July 06, 2009

Public Health Physicians Group Blasts FDA Tobacco Legislation; Cites Philip Morris' Role, Lack of Science Knowledge on the Part of Tobacco-Free Kids

The Democracy Now web site features an interview with Dr. Joel Nitzkin, head of the tobacco control task force of the American Association of Public Health Physicians. Dr. Nitzkin blasts the FDA tobacco legislation, arguing that it was crafted by Philip Morris as part of a deal between the tobacco company and the Campaign for Tobacco-Free Kids.

Dr. Nitzkin's primary argument is that the legislation is essentially a political scam in that it allows the health groups to claim victory over Big Tobacco but that it actually contains very little of substance to fight Big Tobacco. Dr. Nitzkin states that the bill "provides the appearance of the federal regulation of tobacco products while assuring the Philip Morris company of the ability to continue to market their current and currently proposed cigarette products with little interference from federal authorities, protection against future liability and protection from competition from other tobacco companies and from smokeless tobacco products."

Dr. Nitzkin is very clear in asserting that the bill was crafted by Philip Morris and that it was the result of Congressionally-mediated negotiations between the nation's largest tobacco company and the Campaign for Tobacco-Free Kids. Nitzkin also argues that while Philip Morris had its act together and knew exactly what it was doing, the Campaign for Tobacco-Free Kids had no idea of the science behind tobacco control. He states: "The bill was negotiated between Philip Morris and Tobacco-Free Kids, and it appears from the actual text of the bill that the Philip Morris people did their homework very well and knew exactly what they wanted, while those appointed from Tobacco-Free Kids to negotiate on behalf of the public health community really had no understanding of tobacco-related science, of how and why kids initiate tobacco use, or the steps that could be taken to stop them. So it resulted in a bill that gives the appearance of effective regulation, but not the substance. And with the exception of the graphic warnings, which were added in the Senate, not in the original House bill, every provision having to do with restriction of marketing of tobacco products falls into one of two categories: either it’s already in place as a result of the Master Settlement Agreement, or it has already been thrown out by the US Supreme Court."

As an example of a compromise that was inserted to appease the interests of Philip Morris and which represents a provision which is all propaganda and no substance, Dr. Nitzkin discusses the menthol exemption: "The one additive that really makes a difference is menthol, which is both a flavoring and a local anesthetic. And the purpose of menthol was to make cigarette smoking accessible to people who otherwise could not tolerate the harsh feel and taste of the smoke. About 80 percent of African American smokers smoke menthol cigarettes, as do a large number of non-African American smokers. But menthol was specifically included as allowable in the FDA legislation, because Philip Morris objected, saying if you eliminated menthol, that would eliminate 28 percent of our sales."

Dr. Nitzkin goes on to point out the two-fold flaw of the bill's reduced risk provisions. On the one hand, the bill makes it impossible for truly safer products to be marketed successfully. On the other hand, the bill contains a loophole which allows companies to market products as reduced exposure products - which the public will assume implies a degree of safety - without any proof that the product is actually safer. As Dr. Nitzkin explains this loophole: "if a cigarette company wants to market its cigarette as lower exposure, all they have to do is change the chemical composition by that small amount, and then they can advertise it as lower exposure without any scientific proof that it’s safer or less risky."

Finally, Dr. Nitzkin attacks the most central tenet of the legislation: that cigarettes can be made safer by reducing the levels of - or eliminating - some of the specific chemicals in tobacco smoke: "The thrust of the bill is to make cigarette smoke—cigarettes safer by deleting certain hazardous chemicals in them. But there’s already good—pretty good research out there that shows if you eliminated all of the forty most prominent carcinogens in cigarette smoke, you would only reduce the risk of cancer by one or two percent. It’s become abundantly clear over the years that the problem is products of combustion, saying if you dried, shredded and rolled up cabbage or broccoli or even carrots, and people smoked as much of that stuff as they did cigarettes and inhaled it as deeply into their lungs at that very hot temperature, they would get the same risk of heart disease, cancer and other diseases. So this business of making cigarette smoke safer by changing the ingredients has got no scientific basis whatever, and it’s another giveaway to Philip Morris."

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Friday, July 03, 2009

While Health Groups Congratulate Themselves for Eliminating Flavored Cigarettes, New Marlboro Full-Flavored Cigs Sell for as Little as $2.39 per Pack

While the Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society, and American Lung Association are busy congratulating themselves for what they have said is the elimination of flavored cigarettes, those of us who actually are concerned with the substance of tobacco control rather than the propaganda are dealing with the real-world problem of the marketing of a new full-flavored menthol cigarette which is apparently targeting young people, especially African Americans.

While the health groups pat themselves on the back, Marlboro Blend No. 54 is selling for as little as $2.39 per pack, a price which is affordable for many youths and will certainly help entice youths to try this particular product. In addition, the taste of the cigarette is described by many smokers as being relatively mild but full of flavor, a characteristic that seems likely to appeal to young people.

What we have here, unfortunately, is a situation where the health groups are more concerned with pomp and circumstance than substance, more devoted to propaganda and fund-raising capabilities than actually fighting Big Tobacco, and more interested in the easy, politically correct, and quick hitting, marginal window-dressing plan than with the aggressive, science-based, core approach that would actually make a significant difference in reducing youth smoking and saving lives.

The cigarette flavor lie is just one example of the fact that the FDA tobacco legislation is designed to make it look like health groups are doing something when there is little substance behind the bill. It allows the groups to claim that they have ended the devastating problem of cherry, banana, pineapple, and chocolate cigarettes which have been addicting and killing our children.

Of course, what the groups aren't telling the public is that our children aren't smoking cherry, banana, pineapple, and chocolate cigarettes. They are smoking menthol cigarettes, and menthol is exempt from the legislation's flavoring ban.

Similarly, the health groups are telling the public that the legislation is going to allow us to finally address the problem of the addiction of our children to cigarettes. But the truth is that the bill does nothing to address addiction. In fact, it does just the opposite. It institutionalizes addiction. It ensures that nicotine will always be a component of cigarettes, and thus the cigarette companies will be able to continue using nicotine to addict young people and ensure long-time customers.

Third, the health groups are telling the public that the legislation is going to make cigarettes safer. But at the same time, even experts who supported the bill have acknowledged that this is a scam and that the truth is that we have no idea whether cigarettes can even be made safer merely by restricting the levels of or eliminating certain constituents of the smoke.

Fourth, the health groups are telling us that the FDA has meaningful and effective authority to protect the public from the hazards of tobacco products. But the truth is that the FDA has extremely limited authority and that the limits on its powers are in each of the areas where it could otherwise potentially make a serious dent in smoking rates. The groups are also not revealing that the legislation provides unprecedented special protections to Big Tobacco that no other company enjoys.

When the FDA decided yesterday to require a black box warning on Chantix, you can bet that Pfizer was not part of the panel that considered whether or not to impose this warning. But the tobacco companies area afforded the extraordinary gift of being allowed to sit at the table when decisions about the potential regulation of cigarettes are made.

The introduction of Marlboro Blend No. 54 is a chilling reminder that the real work of tobacco control is not going to be accomplished through the political scam that is the FDA tobacco legislation. In fact, the FDA legislation actually makes the real work of tobacco control much more difficult.

What the legislation does is to divert countless resources and substantial attention away from the science-based programs and policies which would actually continue to have an impact on smoking rates. Instead, we will be wasting our time, money, and precious resources on creating a bureaucracy which accomplishes virtually nothing of any substance or meaning.

In the end, the most damaging aspect of the FDA tobacco legislation will not be the legislation itself, but its diversion of attention and resources from the real measures that need to be taken to reduce the demand for cigarettes in the first place.

While the health groups inside the beltway celebrate their political victory, Philip Morris is busy selling full-flavored menthol cigarettes to young people at $2.39 per pack.

How Philip Morris can sleep at night is beyond me. Just thinking about what to do with all those profits that are going to accrue from the coup of this legislation would keep me up at night.

How the health groups can sleep at night, however, is even more mystifying to me.

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Thursday, July 02, 2009

New Study Finds Additional Reason for Recent Declines in Heart Attacks; Casts Further Doubt on Conclusions of Helena Study and Others of Its Ilk

A new study published last month in the journal Medical Care found that reduced use of hormone replacement therapy in women since 2002 has led to a significant decline in heart attacks among women (see: Shetty KD, Vogt WB, and Bhattacharya J. Hormone replacement therapy and cardiovascular health in the United States. Med Care 2009; 47:600-606).

According to a Heartwire article: "A new study in the general US population has found that the sharp drop in use of hormone-replacement therapy (HRT) in the three years from 2002 onward was associated with significantly fewer MIs among women, but that the stroke rate was unaffected. Dr Kanaka D Shetty (RAND Corp, Santa Monica, CA) and colleagues report their findings in the May 2009 issue of Medical Care. They explain that the use of HRT was curtailed dramatically in 2002 following the results of the WHI trial, which found that HRT increased the risk of coronary heart disease in healthy postmenopausal women. This was in contrast to the prior perceived benefit of HRT on cardiovascular risk—Shetty et al thus exploited this "natural experiment" to see whether the cardiovascular harms (or benefits) of HRT seen in randomized controlled trials such as WHI extended to the general population of women. "We found that the decline in US HRT use after 2002 appeared to cause a decline in the AMI rate (while controlling for other factors); we did not observe statistically significant changes in the stroke rate," Shetty told heartwire."

The Rest of the Story

This finding has important implications for the interpretation of results from the Helena studies and others of its ilk. The present study suggests an alternative explanation for the observation of reduced heart attack rates following the recent implementation of smoking bans in places like Helena, Pueblo, Bowling Green, and elsewhere. A decline in the use of hormone replacement therapy may partially explain such findings. Since no previous studies have controlled for the decreased use of HRT, this remains a plausible alternative explanation for the Helena et al. conclusions and casts further doubt on those conclusions.

Note that I am not questioning the validity of the finding that heart attack rates have declined in localities that have enacted smoking bans. The issue is whether the observed declines are attributable to the smoking bans themselves, rather than to other secular changes that have occurred during the same time period. Most of the existing studies are before-after studies and the conclusions have been largely based on the finding of a reduction in heart attacks from before to after the smoking ban. However, secular changes concurrent with the implementation of these bans could also explain such findings. The demonstration that decreased use of HRT which occurred during exactly the same period when most of the smoking bans studies took place casts doubt on the conclusion of those studies, as it introduces an additional alternative explanation for the study results.

I have already explained that factors such as improved treatment for cardiovascular disease, including advances in angioplasty and thrombolytic techniques and increased use of statin drugs to control cholesterol have contributed to the recent observed declines in heart attack rates. This study simply adds an additional factor that would also explain the finding of reduced heart attacks in these studies.

The problem with the conclusions from the Helena et al. studies are two-fold. First, these studies have not been able to rule out the possibility that the observed declines in heart attacks are more than just random variation in the data. Second, these studies have not been able to rule out the possibility that other factors were responsible for the decline in heart attacks. The research I am reporting on today adds an additional factor that needs to be considered, but that has not been addressed in any of the existing research.

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Wednesday, July 01, 2009

UK National Smoking Cessation Conference Prostitutes Itself By Allowing Itself to Be Bought by Big Pharma; No Wonder Tobacco Control Science is Biased

The 2009 UK National Smoking Cessation Conference was held last week. The conference boasts that: "Presentations, workshops and debates cover all aspects of the policy and practice of helping smokers to stop. The conference is the leading forum for discussion of evidence based service delivery and community innovations." The conference is supported by a wide range of tobacco control and health organizations, including the British Heart Foundation, British Medical Association, British Medical Foundation, and Cancer Research UK.

The Rest of the Story

While this conference might sound good on paper, the rest of the story is that the conference's major sponsors were four large pharmaceutical companies that market smoking cessation products.

The sponsors were:
  • GlaxoSmithKline (which markets Wellbutrin and Zyban, Commit lozenges, Committed Quitters, NiQuitin CQ/Nicoderm, CQ/Nicabate, and Nicorette);
  • McNeil Products Ltd (which markets Nicorette products);
  • Novartis (which markets Nicotinell and Habitrol);
    and
  • Pfizer (which markets Chantix, Nicotrol NS, and Nicotrol Inhaler).
In addition to the overall conference being sponsored by Big Pharma, a number of individual scientific sessions were also sponsored by pharmaceutical companies. For example, the lunch talk on approaches to smoking cessation was sponsored by GlaxoSmithKline. A dinner talk on educating smoking cessation personnel was sponsored by Pfizer. A session on the importance of support in relapse was sponsored by McNeil. And a symposium on best practices was sponsored by Novartis and its Nicotinell product.

If you look at the topics discussed at the conference, you'll note that the entire focus is not on policies to promote smoking cessation, but instead is on ...

... you guessed it ...

... pharmaceutical treatment of nicotine dependence.

This is not a scientific conference at all. It is basically a huge marketing and public relations opportunity for the pharmaceutical companies that manufacture or market smoking cessation products.

Given the extent of the sponsorship -- of both individual sessions and the entire conference -- by Big Pharma, there is simply no way that this conference could have offered a scientifically objective and appropriate treatment of policy issues related to promoting and enhancing smoking cessation.

Even in the one session that acknowledged the role of spontaneous, unplanned, abrupt quit attempts, the emphasis was not on how this argues against a purely pharmaceutical-based model of smoking cessation promotion. Instead, the entire emphasis of the presentation was on how to increase pharmaceutical profits by figuring out a way to get abrupt quitters to use pharmaceutical aids.

By prostituting itself and allowing Big Pharma to essentially co-opt the entire conference, the UK National Smoking Cessation Conference has given up its role as a scientific conference and has instead essentially turned itself into a huge marketing opportunity for the pharmaceutical companies.

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Tuesday, June 30, 2009

Humana of Ohio Announces that It Will Start Practicing Lifestyle Control for Its Employees

Humana of Ohio - a health care insurance company - announced earlier this month that all new employees who smoke will be required to enter a smoking cessation program within 30 days or else be fired from the company. Similar requirements will not hold for Humana's employees who work in neighboring areas in Kentucky because that state has a law which prohibits employment discrimination against smokers. According to the company, the purpose of the program is to improve employee wellness in order to reduce health care costs and improve productivity.

According to an article in the Louisville Courier-Journal: "The Louisville-based insurer, which employs more than 1,200 people at its new operations in Cincinnati's Walnut Hills neighborhood and hundreds more at a distribution center in West Chester, said Monday, June 15, that it would give all new employees a questionnaire. If the workers use tobacco, they will have 31 days to enroll in a company program called Breathe. The company said the new requirements are part of a continuing commitment to employee wellness programs to shave costs and improve productivity. According to a Humana press release, its Breathe program is offered to all of its employees as part of the health initiatives. It is only mandatory for new Humana of Ohio employees. The company’s new regional headquarters and customer service center, located near downtown Cincinnati, was designed to foster employee health and wellness, Humana says. Features include walking tracks on three floors, an on-site fitness center, healthy food service, and well-lit stairwells to encourage exercise. Humana said in its release that it 'puts a strong emphasis on personal responsibility for health and wellness, which lead to improved quality of life and greater workplace productivity.'"

The Rest of the Story

Unfortunately, this new Humana policy isn't about saving health care costs and improving productivity at all: it's about controlling its employees' lifestyles and picking on smoking as one particular behavioral decision that cannot be tolerated.

If the true concern were saving health care costs, then Humana would be requiring smokers to actually quit smoking, or else be fired. Instead, the requirement is simply that employees agree to enter a smoking cessation program. It apparently doesn't matter if the program works or not. The important point is that the company has been able to express its disapproval of the smoking decision and to coerce the employee into entering such a program, whether the smoker actually quits or not.

In fact, the effectiveness of these types of smoking cessation programs is dismal and the majority of smoking employees who enter them will not quit. Thus, for most employees, the policy will not save any health care costs at all. It will not result in any change in the individual's health status; it will simply scold the employee for that health decision.

In contrast to the way the company is handling the decision to smoke, Humana is apparently not requiring obese or overweight employees to enroll in a weight loss program. It is apparently not requiring employees who are not physically active to log a certain number of hours each week on the treadmill. It is not mandating that workers who eat a crappy diet enroll in a nutrition education program.

All of these other employee wellness initiatives are voluntary. The only mandatory aspect of the company's wellness program is smoking cessation -- or to be more accurate, participation in a smoking cessation program which is, in the majority of cases, not going to be successful.

What's most interesting to me is why Humana would choose to handle smoking in a very different way than all other health behaviors. The company clearly is concerned about a range of behaviors. It has walking tracks, a fitness center, and well-lit stairwells to encourage exercise and a healthy food program to encourage improved nutrition.

However, all of these aspects of its wellness program are optional. Employees are not monitored to see if they do indeed go up and down the stairs. Their use of the fitness center is not mandatory. They can choose to use or not use the walking tracks. But the smoking cessation program: mandatory.

This raises the question of what else is going on here besides just a concern about employee health and wellness. The inconsistent treatment of smoking compared to other health-related behaviors suggests to me that smokers are being discriminated against for a reason other than a pure concern for health. I believe that a disapproval of smoking underlies this policy. But why a disapproval of smoking, but not of eating excessively or not exercising?

I think it's because it has become acceptable to scorn, punish, and discriminate against smokers. But to treat any of the other health-related behaviors in the same way would be immediately and strongly condemned because it is socially unacceptable.

In other words, intolerance of smokers has become socially acceptable in a way that intolerance of other health-related behavior decisions has not.

Humana of Ohio certainly has the right to implement this policy, but they should at least call it what it is: it's not a health and wellness program, it's an attempt to control the lifestyle of its employees.

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Monday, June 29, 2009

What are the Health Groups Smoking? How Could a Bill Championed by Philip Morris Possibly Result in a Huge Reduction in Youth Smoking?

The latest and saddest chapter of tobacco control history could easily have been prevented had only the anti-smoking and health groups applied a slight dose of common sense to their analysis of the FDA tobacco legislation.

As I've commented in the past week, this legislation is a huge hoax. It is a piece of legislation that is designed to make it look like Philip Morris, politicians, and the health groups are doing something about the smoking problem when in reality, the bill does nothing to challenge the status quo and contains provisions that are essentially window dressing: marginal changes that produce no meaningful or effective reductions in smoking or improvements in the safety of cigarettes and the protection of the public's health.

Even worse, it now gives cigarettes an FDA stamp of approval. Hundreds of thousands of Americans will continue to die from smoking-related disease, except now it will be with the blessing of the United States government and the health groups.

The reason for the failure of the bill to take meaningful action against tobacco is simple: it was crafted by Philip Morris. The nation's largest cigarette company was present at the negotiating table and had to give its approval to each provision in order for the bill to move forward.

So of course the bill is not going to meaningfully change the status quo or make any substantial reductions in youth smoking. If the bill were to substantially threaten cigarette sales and long-term profits by reducing the number of youth smokers, of course Philip Morris would not have supported this bill.

Senator Bob Bennett (R-UT) wrote a very nice piece in the Salt Lake Tribune in which he explains that his opposition to the FDA tobacco legislation was not that the bill did too much to reduce youth smoking, but that it did too little. Senator Bennett opposed the bill specifically because it contained "loopholes that benefit Big Tobacco" and because he believes "Philip Morris should stay out of the process of writing tobacco legislation."

Bennett writes: "Recently, Congress passed Sen. Ted Kennedy's Family Smoking Prevention and Tobacco Control Act and President Barack Obama signed it into law on Monday. At face value, this bill sounded like a good idea and it gained overwhelming support in both the House and Senate. However, its biggest support came from Big Tobacco, the very companies whose product the Food and Drug Administration will be asked to regulate. That fact gave me pause. When I looked at the fine print, I discovered that this bill increases one company's domination in the market, has little effect on reducing deaths and disease associated with tobacco, and places the authority of regulation of tobacco in the wrong hands. ... I'd still have voted for it if I had thought it would protect public health by focusing on prevention to reduce death and diseases associated with tobacco. However, reports indicate that the bill will achieve only modest results in improving public health. ... so let me be clear that my vote against the Kennedy bill does not mean that I do not support the intent of the bill. I opposed it because after reading the fine print, I was convinced we would do better if we told Philip Morris to stay out of the process of writing tobacco legislation."

The Rest of the Story

It is pitiful that the anti-smoking groups and health groups which supported this legislation are of the opinion that Philip Morris belongs in the business of crafting tobacco legislation and that inviting Philip Morris to the table where this legislation is hammered out is an appropriate way to formulate public health policy.

But it is truly mind-boggling that these groups would accept the premise that Philip Morris is a changed company and that somehow, it will now support legislation that will substantially reduce its profits by making a meaningful dent in youth smoking.

Frankly, Philip Morris would be irresponsible to its shareholders if it supported legislation that would significantly reduce youth smoking. That is the last thing in the world that Philip Morris wants if it is to remain in business with the kind of profits that it enjoys. Any executive who supported such a measure would be cast out of office immediately. And probably should be. After all, Philip Morris is not in the business of saving lives or protecting children. It's in the business of selling cigarettes.

I have long taught my public health students that the easiest way to evaluate a public health policy is to see if Philip Morris supports that policy or not. They have a lot more insight and a lot more research and experience available to them and a lot more is at stake for them than for us. Thus, they have to get it right. If they support a policy, you can be assured that it is not one that is going to reduce youth smoking and save lives to the extent that the health groups have boasted.

I have already presented a detailed analysis of the specific provisions of the legislation and a point-by-point accounting of the reasons why the bill will not reduce youth smoking, but will likely increase it. While this science-based argument did not work in changing the minds of the health groups, I am frankly surprised that the more common sense based argument did not sway these groups.

It is painfully obvious, even to the majority of the public I believe, that a bill supported by Philip Morris and crafted by the nation's largest cigarette company is not going to be one that is beneficial for the public's health.

To save lives, you either need to make cigarettes safer (which this bill does not do; and if anything it does the opposite by precluding safer cigarettes from the market) or you need to reduce smoking (which as Senator Bennett points out, this bill does essentially nothing to achieve and which is not going to occur in a Philip Morris-sponsored piece of legislation).

The rest of the story is that while the anti-smoking and health groups were unethical in their willingness to allow Philip Morris to craft legislation to determine the terms of their own regulation, these groups were stupid to fall for the notion that Philip Morris has suddenly changed and now supports measures that will substantially reduce its profits by decimating youth smoking.

The worst part of the story, however, is that these groups continue to lie about the nature of the legislation (that it was opposed by "slick tobacco lobbyists" and that it bans all cigarette flavorings). Timothy Carney, in his piece in the Washington Examiner last week, points out that Philip Morris lobbying far exceeds that of the next closest company and that the overwhelming amount of Big Tobacco lobbying regarding the FDA legislation was in favor of the bill.

As Carney writes: "President Barack Obama signed a bill Monday that the largest tobacco company in America had championed for years. Obama nevertheless claimed he had taken on Big Tobacco and won. ... But on Tuesday morning, the home page of Philip Morris, which controls a majority of the U.S. cigarette market, blared “Philip Morris Supports Federal Regulation of Tobacco.” Was Obama ignorant of the $40,000-a-day pro-regulation lobbying effort by the country’s biggest cigarette maker? Was Obama surprised by the applause Monday from Philip Morris’ parent company Altria, calling the bill “an important and historic achievement”? Altria’s support Monday didn’t reflect some conversion on the road to the Rose Garden. Altria stated it “has supported tough but reasonable federal regulation of tobacco products for more than eight years.” ...

"Obama’s rhetoric painted the opposite picture. Obama said in signing the bill, “despite the best efforts and good progress made by so many leaders and advocates with us today, the tobacco industry and its special interest lobbying have generally won the day up on the Hill. … Fifteen years later, their campaign has finally failed. … Today, change has come to Washington.” The kernel of truth in Obama’s claims is that the smaller cigarette makers — perceiving that this bill will protect and enhance Philip Morris’ dominance of the industry — have mostly opposed the legislation. But it’s misleading to claim you’re battling the “tobacco industry” when you’re siding with the industry’s 900-pound gorilla. Philip Morris sells more cigarettes than every other company combined — representing 50.4 percent of the U.S. market in the fourth quarter of 2008. There were more packs of Marlboros sold in the United States in 2008 than all R.J. Reynolds and Lorillard brands combined." ...

"Regarding that “special interest lobbying” Obama claimed to be battling, Philip Morris is the unrivaled industry king. Since 2003, the tobacco lobby has spent $155 million. Altria spent a majority of that — $83 million. Although the rest of the industry was lobbying against this bill, most of the lobbying money was on the pro-regulation side. Altria retained 16 outside lobbying firms at the start of 2009 and has added four more since then, three of which were lobbying for this bill. Altria is also the leading campaign contributor in the industry. In 2008, Altria gave 66 percent more to politicians than did runner-up R.J. Reynolds."

"“When I ran for president,” Obama said Monday as he signed the Philip Morris-championed bill, “I did so because I believed that despite the power of the status quo and the influence of special interests, it was possible for us to bring change to Washington.” ... it’s hard to square this rhetoric with his signing this bill. ... Obama may represent “change,” but — in this case at least — not the sort you can believe in."

It is dishonest of the health groups to claim that they have taken on Big Tobacco and its slick lobbyists and won. What they've done is sat down with the biggest and slickest of the lobbyists and allowed them to write the legislation.

To then tell the American people that you've fought these lobbyists and won is dishonest and unethical. We deserve a lot better than this from the leading national health organizations in tobacco control. But we're not going to get it. So far, not a single one of these groups has corrected its dishonest communications to the public.

It's quite clear: lying is not acceptable for Big Tobacco. But it is acceptable for tobacco control organizations. As long as you're working "for the children" and not against them, you can lie all you want.

Of course, this means that Philip Morris is now working "for the children." It's only appropriate that we now allow them to start lying again since they're now on our side.

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Friday, June 26, 2009

Another Day, Another Lie: American Cancer Society Deceives Constituents Into Thinking Big Tobacco Lobbyists Were All Fighting the FDA Tobacco Bill

Moving now at a pace of a lie a day, the American Cancer Society sent out a communication to its constituents implying that the FDA tobacco legislation was enacted because the voices of slick tobacco lobbyists were ignored.

The communication states: "It wasn't easy, but Congress and the President are standing up to Big Tobacco with an exceptional new law that makes it harder for tobacco companies to push their product. It's a monumental victory in our fight against cancer. As it turns out, there's one thing more powerful than slick cigarette lobbyists -- the voices of real people from all across the country fighting for change. Please take a moment to thank Congress and President Obama for enacting the Family Smoking Prevention and Tobacco Control Act."

The Rest of the Story

This communication clearly implies that slick tobacco lobbyists were fighting the FDA tobacco legislation. It suggests uniform opposition by Big Tobacco to the FDA bill and an effort by the tobacco lobbyists to kill the bill.

As we know, the truth is that Philip Morris - the largest company within Big Tobacco and the company with the overwhelmingly highest amount of lobbying expenditures in Congress - supported the bill and lobbied for its passage. Thus, the "slick cigarette lobbyists" from Philip Morris were promoting the bill and any Congressperson who voted for this legislation was supporting, not opposing, the interests of these "slick cigarette lobbyists."

Timothy Carney picked up on this type of act of deception in his Washington Examiner column on Wednesday, when he wrote that: "it’s misleading to claim you’re battling the “tobacco industry” when you’re siding with the industry’s 900-pound gorilla."

What the American Cancer Society is claiming here is more than just deceptive, in my opinion. It's not merely that the ACS is claiming that they were fighting Big Tobacco. They are making a specific claim that the "slick cigarette lobbyists" were opposing the bill and that it was the public's expression of support for the bill which overcame the work of these lobbyists.

I would opine that this is outright false. The largest chunk of Big Tobacco lobbyists and Big Tobacco lobbying money went into supporting this legislation. If anything, the legislation passed because of the work of "slick tobacco lobbyists."

And no, I do not believe for a minute that the power of the smaller companies' lobbyists could outweigh the impact of Philip Morris' lobbyists given the companies market dominance, Congressional influence, and dominance in terms of campaign contributions and lobbying expenditures.

Let me also just add that the slickest lobbyists involved with this bill were not from the tobacco companies, but from the health groups. It was those lobbyists who were able to sell a bill of goods to the Congress and convince legislators that this legislation was a strong public health measure that would save lives by mandating safer cigarettes, eliminating cigarette flavorings, eliminating cigarette advertising directed at kids, and reducing youth smoking.

The rest of the story is that the rhetoric of the leading anti-smoking organizations - including the Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, and American Lung Association - is really no better than that of the tobacco companies. Both have lied to, and deceived the public.

And frankly, a lie is a lie. Just because the lie is coming from a "good guy" doesn't make it any more excusable. It's still a lie. It's still unethical. It's still unprofessional. And it's still inappropriate.

And in some ways, it's even worse coming from public health groups, because they are bound by an ethical code of conduct.

These health groups are destroying not only the public health practice of tobacco control and the federal framework for tobacco control practice in the United States, but they are also destroying the entire ethical integrity of the national tobacco control movement.

If you take the time to re-read the posts I've written during this week, I think you'll see the extent to which the behavior of these organizations is unethical and inappropriate and the extent of the damage that these groups are doing to the practice of tobacco control and the protection of the public's health.

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Thursday, June 25, 2009

When Big Tobacco Says Fewer Carcinogens Means Safer, It's a Fraudulent Lie; When the Anti-Smoking Groups Say the Same Thing, It's Their Best Argument

The anti-smoking and health groups which promoted the FDA tobacco legislation based the bulk of their argument in support of this bill on their assertion that FDA regulation of tobacco products would make cigarettes safer by virtue of the FDA requiring the reduction or elimination of certain toxic and carcinogenic chemicals in cigarettes or tobacco smoke.

For example, the Campaign for Tobacco-Free Kids boasts that the new FDA tobacco legislation will "empower the FDA to require changes in tobacco products, such as the removal or reduction of harmful ingredients or the reduction of nicotine levels."

Today I reveal, however, that these very same groups recently attacked the tobacco companies for making exactly the same argument. At that time, these groups told the public that this very argument was fraudulent.

In a special report entitled "Big Tobacco's Guinea Pigs: How an Unregulated Industry Experiments on America's Kids and Consumers," the Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, and American Lung Association attacked the cigarette companies for marketing new products with reduced levels of, or elimination of, a number of the carcinogens in tobacco smoke. The health groups claimed that the tobacco companies were fraudulently lying and that there was no evidence that having fewer carcinogens translates into being a safer cigarette.

The report laments that: "Over the past several years, a number of new tobacco products have been introduced to consumers with unproven claims of reduced risk. These products have included cigarettes like Omni and Advance, or tobacco lozenges like Stonewall and Ariva. These products are only the beginning of a series of new products being unveiled by the tobacco companies in an effort to address the health concerns of current tobacco users and to provide an alternative product to individuals seriously considering quitting tobacco use altogether."

"Omni was produced and marketed by Vector Tobacco, Ltd, with the statement, “Omni has significantly reduced those carcinogens that are the major causes of lung cancer in smokers. Compared to any other cigarette currently on the market, Omni delivers less carcinogens to the smoker. While Omni has not been proven to reduce the health risks of smoking, Omni’s reduced carcinogen levels are a logical and important first step. If you smoke, Omni is clearly the best alternative.” The magazine ad claims, “Introducing the first cigarette to significantly reduce carcinogenic PAH’s, nitrosamines, and catechols, which are major causes of lung cancer in smokers.” There has been no evidence supporting any of Vector’s claims for Omni."

The Omni ad states: "What happens to a cigarette when you reduce carcinogens?" Another Omni ad says: "Reduced carcinogens. Premium taste."

So what the health groups are saying here is that the tobacco companies are deceiving the American public by claiming that there is any connection between the reduction of carcinogens or toxins in a tobacco product and the safety of that product. This would be the only grounds for these health groups to attack Vector for stating in its ads that these cigarettes reduce levels of various toxins and carcinogens. If the health groups believed, at the time, that reductions of the levels or number of carcinogens and toxins in tobacco smoke was connected in some way to reduced health risks, then there would be no valid compliant against Vector for advertising the elimination of various toxins and carcinogens.

Now, however, the very same health groups are making exactly the same argument for which they attacked Vector: that the FDA can mandate a safer product by reducing or eliminating toxins and carcinogens in tobacco smoke. In other words, these groups are asserting that there is a connection between the levels and number of these toxins and carcinogens and the health risks for smokers.

The Rest of the Story

As the health groups should know based on abundant scientific evidence, there is no reason to believe that the reduction of certain toxins and constituents in tobacco smoke translates into a safer cigarette. A number of products which made such claims have been tested and no evidence has yet been produced to suggest that they are any safer. If anything, products which have documented lower yields of carcinogens have been found to pose a much greater risk of lung cancer among smokers. In other words, lower yield products are believed to be more dangerous, not less dangerous, for smokers. Clearly, we cannot assume that lower levels of carcinogens and toxins means a safer cigarette.

This blows the health groups' main argument in support of the FDA legislation right out of the water.

That would be fine, and we could merely conclude that the health groups were guilty of making a fallacious argument, were it not for the fact that those same health groups attacked cigarette companies for making that very argument.

In other words, the Campaign for Tobacco-Free Kids, ACS, AHA, and ALA are two-faced, double-sided, smoke-blowing hypocrites.

When Big Tobacco says fewer carcinogens means a safer cigarette, these groups tell the public that the companies are full of crap, and they take them to court and try to convict them as being guilty of lies, deceit, and fraud.

But when the health groups then make the very same argument - that fewer carcinogens and toxins will mean a safer cigarette - they apparently now suddenly believe that argument to be true.

Perhaps these health groups should come out with a new special report entitled: "Big Government's Guinea Pigs: How the Federal Government Experiments on America's Kids and Consumers."

If a governor of South Carolina who opposed same sex marriage on the grounds that a marriage should be between one man and one woman hadn't just been found gallivanting around in Argentina with a mistress, I would have said that these health groups were guilty of the most hypocritical action of the day. But I still think they come in a close second.

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Wednesday, June 24, 2009

On Day that Anti-Smoking Groups Boast that Tobacco Companies Will No Longer Entice Kids With Flavored Cigarettes, Philip Morris Announces Blend No. 54


Product is a Bold, Full-Flavored Menthol Cigarette Directed at Young African Americans


The anti-smoking groups which supported the FDA tobacco legislation are living in a fantasy land, completely isolated from the real world of Big Tobacco politics, wheeling and dealing, and marketing, and no where is that more evident than the twin events of yesterday.

On the one hand, the American Cancer Society lied to the public, boasting that "Our nation's children – potential first-time smokers – will no longer be seduced by flavored tobacco products, including candy- and fruit-flavored cigarettes, which will be banned." Other health groups deceived the public in a similar fashion, telling us that candy-flavored cigarettes will be no more, but failing to mention that menthol flavoring is exempt. Even President Obama got into the act, boasting that candy and fruit flavorings will be banned, but conveniently hiding the fact that menthol flavorings are exempt.

So we were led to believe by the health groups that the days of cigarette companies using flavorings to entice our children into smoking are over.

At the same time that the health groups were busy patting themselves on the back in the Rose Garden for getting rid of flavored cigarettes that nobody smokes, Philip Morris was announcing the introduction of a new flavored cigarette -- perfectly legal and acceptable under the new law -- designed specifically to entice and addict young people, especially African Americans: Marlboro Blend No. 54.

Apparently, we were lied to by the health groups. If cigarette flavorings, including candy flavorings like menthol, are banned, then why is Philip Morris introducing a new menthol-flavored cigarette which is perfectly legal under the new legislation?

The answer is simple: the bill does not ban all flavors and not even all candy flavors. It exempts menthol, which is actually a common flavoring used in candy. Haven't you ever tried Airwaves cherry menthol candy? Have you not tried Kanro's Super Menthol candy? How about Honees Menthol Honey candy?

Well, the good news is that the honey in Honees menthol honey candy is banned from cigarettes; the bad news is that the menthol flavoring in Honees menthol honey candy is not.

Of course, the other part of the bad news is that no one is smoking honey cigarettes, while literally millions of Americans, including many youths, are smoking menthol cigarettes.

So I guess we didn't quite get rid of all candy-flavored cigarettes, did we?

And so while the health groups were busy telling an outright lie to the American public -- that cigarette flavorings and candy flavorings were banned -- Philip Morris was busy making plans for the enticement of the next generation of smokers through the use of a wonderfully attractive candy flavoring: menthol.

And there seems to be little doubt who Philip Morris is targeting with this product. Do you think the number 54 for this new Marlboro menthol blend is just a coincidence? Was it chosen by a random number generator?

Or is it possible that the number 54 has a special meaning, particularly to an African American population that may be largely familiar with urban slang, in which "54" is often used to refer to "a very hot girl with a really fine ass." (Those are not my words, I'm quoting directly from the urban slang dictionary). Other uses of "54" in urban slang include "a leet counter-strike invite club, for leet cs players" and "a term used to emphasize legal legitimacy."

Although the leading anti-smoking groups which promoted the FDA legislation would have us believe that the battle for youth and young adult market share is the banana market, the pineapple market, the cherry market, and the chocolate market, anyone living in reality rather than political and propaganda fantasy land knows that the true battle for youth and young adult market share is in the menthol market.

While the flavors banned by the FDA legislation make up perhaps 0.1% of cigarettes smoked by youths at the most, menthol cigarettes make up about 28% of the overall domestic cigarette market. The percentage is even higher among African American youths, where menthol cigarettes have about an 80% market share.

Maybe if African American kids start to smoke and we are at least protecting white kids, it is a public health victory; but where I come from, public health is about social justice and the health groups should be ashamed of themselves for supporting a bill that sells out the health of African American children for the profits of Big Tobacco, and then lying about it to try to hide that fact from the public.

If exempting menthol was necessary to retain Philip Morris' support for the legislation and keep the back room deal alive, then so be it. But don't stand in front of the American people and lie about it. Don't hide the fact that menthol was exempted as a political compromise. Don't lie to us and tell us that all flavorings are banned by the bill. Don't lie to use and tell us that all candy flavorings are banned by the bill.

Just stand up like a man or woman and tell us that you made a political compromise for the sole purpose of retaining Philip Morris' support.

Lying is supposed to be a technique used by the tobacco companies, not by us in public health. Apparently, that's no longer the case.

The rest of the story is that the bill's provisions for the FDA regulation of cigarettes are essentially window dressing. They are designed to allow the health groups to claim that they beat Big Tobacco, fire up their constituents, and obtain an infusion of donations. But the truth is that back in the real world, the substance of the legislation is missing. The law does almost nothing to actually protect our nation's children from addiction.

The saddest part of the story is this: now we need something to protect us from the lies being told by our own anti-smoking and health organizations.

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Tuesday, June 23, 2009

New England Cable News Segment on FDA Tobacco Legislation

I think the New England Cable News did a fine job of presenting a balanced and evidence-based report on the FDA tobacco legislation -- perhaps the most accurate coverage of the bill's enactment that I have seen.

The segment is here.

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American Cancer Society Lies to American Public About Effects of FDA Tobacco Legislation


Also Deceives Public About Big Tobacco Opposition to Bill


Telling the Truth Would Have Required Admitting that the Bill is a Public Scam Which Does Little to Protect Children from Cigarettes But Lots to Protect Cigarette Sales

In a communication sent to the American Cancer Society's (ACS) network of advocates throughout the nation (including myself) and posted on the Society's web site, the ACS has lied about the effects of the FDA tobacco legislation passed last week by the U.S. House and Senate and signed into law Monday by President Obama.

According to the American Cancer Society's statement: "Our nation's children – potential first-time smokers – will no longer be seduced by flavored tobacco products, including candy- and fruit-flavored cigarettes, which will be banned."

The American Cancer Society is thus claiming that the FDA tobacco legislation bans all flavored tobacco products that might seduce children.

The Rest of the Story

If the American Cancer Society had read the actual text of the legislation or read any of hundreds of newspaper articles about the bill published in the past month alone, it would have easily found out that the bill does not ban all flavored tobacco cigarettes that seduce young smokers. The bill specifically exempts menthol from its ban on cigarette flavorings.

The key section of the bill about which the ACS is lying is section 907(a)(1)(A), which reads: "Beginning 3 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke."

Thus, either the American Cancer Society is somehow unaware that the bill exempts menthol or the ACS is lying to the public.

The former possibility can be ruled out because the ACS itself acknowledged in an earlier communication that the bill exempts menthol: "Some of the most highly visible impacts of the legislation would allow the FDA to: ... Ban all cigarette flavorings other than menthol, that is a characterizing flavor of the product...".

The American Cancer Society is also well aware that menthol is a cigarette flavoring whose primary purpose is to help addict youths by making cigarette smoke less harsh. The ACS itself, in a special report on the topic, stated that cigarette companies use menthol flavoring to: "Numb throat so the smoker does not feel as much throat irritation."

In support of this assertion, the ACS cites a tobacco industry document which argues that a flavoring (such as menthol) which makes cigarette smoke less harsh will help entice youth smokers. According to the ACS report: "The Teague document details a number of product features that make smoking more tolerable for beginning and learning smokers. For example, it discusses methods of reducing harshness, making the flavor bland since new smokers don’t like the taste of the smoke, and improving the “mouth feel” by reducing negatives like hotness and
dryness."

In fact, the ACS report goes into tremendous detail about how the tobacco companies are using menthol to entice young African Americans to smoke (whether you agree with this conclusion or not, my point is that the ACS has certainly concluded and argued to the public that menthol is used to entice young smokers):

"The tobacco companies’ success in using menthol cigarettes to target African American kids is exemplified by the disproportionate number of young blacks who smoke menthol cigarettes. Not only does menthol numb the throat to allow deeper inhaling, the companies know menthol is attractive to their African American targets: “Young blacks have found their thing, and it’s menthol in general and Kool in particular.” It is hardly surprising then that 80 percent of 12- to 17-year-old black smokers choose Newport, the leading menthol brand, compared to just 16 percent of young white smokers. Again, these product design decisions can have a terrible impact on health. Menthol cigarettes have higher carbon monoxide concentrations than non-menthol cigarettes and may be associated with a greater absorption of nicotine. Moreover, research indicates that mentholated cigarettes may increase the risk of both lung and bronchial cancer by promoting lung permeability and diffusability of smoke particles. African Americans are more likely to develop and die from cancer than persons of any other racial or ethnic group. Lung cancer is the second most common cancer in both African American men and women and it kills more African Americans than any other type of cancer."

So the ACS is aware that the bill exempts menthol and has also argued previously that menthol flavoring is used in order to entice young smokers by making the smoke less harsh and in particular, by enticing African American youths who are attracted by the menthol flavor.

Therefore, I am saddened but forced to conclude that the American Cancer Society is lying to its constituents and the public in its communication stating that the FDA legislation bans all cigarette flavorings and thus ends the enticement of youths by these flavorings.

I should say that I am a long-time American Cancer Society supporter, volunteer, donor, and fund raiser and thus it greatly saddens me to see the ACS lie to the public like this.

But the reason for this lie is also clear. If the ACS were honest with the public, it would have to admit that the bill is a public scam which does little to protect children from addiction to cigarettes but lots to protect cigarette sales. Most notably, the bill bans all the flavorings that are not used very often (or at all), such as banana, pineapple, cherry, chocolate, and cherry, but exempts the one flavoring (menthol) which the ACS itself admits is used to entice huge numbers of young smokers, including a disproportionate number of African Americans. The ACS itself tells us that Newport - a menthol-flavored brand - is smoked by 80% of African American teenagers.

It's interesting that when it was trying to get this bill passed, the ACS had no problem featuring the problems of tobacco use in the African American community, but now that the legislation has been enacted, the ACS is now pretending that the African American community doesn't exist and that the enticement and seduction of African American youth smokers by menthol-flavored brands is not a problem.

After all, our nation's youths will no longer be seduced by flavored cigarettes. I guess African American youths are not considered a part of our national community of youths by the ACS. (Obviously, I'm being sarcastic here but my point is that first, the ACS is telling a pretty significant lie and second, that there is a notable tinge of institutional racial discrimination in the ACS' statements and actions).

Clearly, the ACS is afraid to tell the public the truth - that while the bill bans all the flavorings in cigarette brands which are rarely used by youths - it exempts menthol, which is the chief flavoring present in the brands favored by 80% of African American youths.

Let me just note that there is no scientific evidence that cherry, pineapple, and banana are playing any significant role in the enticement of youths to smoke. But there is abundant evidence (presented by the ACS itself) that menthol flavoring plays a critical role in the enticement of literally millions of smokers. When was the last time you saw a group of kids standing around smoking a banana-flavored cigarette? But you see groups of kids standing around smoking Newports all the time.

Telling the public the truth - that the bill exempts menthol - would be an embarrassing admission for the ACS, because it would reveal that the bill is a scam, which allows health groups and politicians to boast about how they are fighting Big Tobacco but which actually fails to confront the key problems which are leading to youth addiction to cigarettes (namely, the menthol flavoring and the nicotine).

Which brings us to the other element of massive deception in the American Cancer Society's communication: the web page tells us that by enacting this law, Congress is standing up to Big Tobacco. It states: "It's not easy to stand up to an enemy like Big Tobacco, but that's what Congress did and what President Obama will do next week."

But the truth is that the largest company within Big Tobacco - Philip Morris - was supporting the legislation!

Thus, it is massively deceptive to suggest that those voting for the legislation were standing up to Big Tobacco. They were actually supporting Philip Morris and helping the company do its bidding in Congress. While we can debate whether the bill was constructive or destructive in spite of or because of Philip Morris' support, it is very clearly not the truth that supporters of this legislation were standing up to Big Tobacco. Big Tobacco was actually split on the legislation, with the smaller companies opposing the bill and the largest company vigorously supporting it.

On the same day that the American Cancer Society declared that the seduction of young people by flavored cigarettes has come to an end due to the FDA legislation, Philip Morris announced that it was introducing a "richer, bolder" flavored cigarette that it hopes will compete with Lorillard's Newport and R.J. Reynolds' Camel Crush. And what is the flavoring in this richer, bolder flavored product which is expected to compete for a significant part of the market and to extend the penetration and market dominance of Marlboro? Is it cherry, chocolate, strawberry, pineapple, or banana? Is it mint, vanilla, coconut, cinnamon, or orange?

No -- it is ....

.... you guessed it...

Menthol.

According to a Bloomberg News article: "The cigarette, called Marlboro Blend No. 54, has a “richer, bolder” flavor than Philip Morris USA’s regular Marlboro menthol and Marlboro Smooth menthol cigarettes... . Retailers and distributors began receiving shipments on June 17, according to an information sheet distributed to wholesalers and confirmed today by Bill Phelps, another spokesman for Richmond, Virginia-based Altria. It’s the first new Marlboro menthol cigarette since 2007. Tobacco companies are pursuing menthol sales, which account for a growing share of the shrinking cigarette market. Reynolds, the second-largest U.S. tobacco company after Altria, has introduced products such as Camel Crush, a cigarette that contains a menthol capsule in the filter that provides flavoring when compressed. “If Altria wants to obtain more market share, it has to expand where the consumer has shown a preference,” Thomas Russo, who manages $2.5 billion of assets at Gardner Russo & Gardner, said in a telephone interview. Menthol is “the only territory where Altria can probably hope to gain share from other brands.” ... The company won’t discuss how it creates different flavors and it won’t comment on how the new cigarette compares with rivals’ menthol offerings, Mathe said. Philip Morris USA trails Lorillard in the menthol category and is using promotions to increase initial deliveries of Marlboro Blend No. 54."

The rest of the story is that the American Cancer Society has lied to its constituents and to the American public, telling us that the FDA tobacco legislation bans all flavored tobacco products that entice youths when the truth is that the bill exempts menthol, which the ACS itself has stated is a cigarette flavoring which is used to seduce youths, especially African American youths.

The days of our nation's children being seduced by flavored cigarettes has not ended, as claimed by the ACS. With the introduction of Marlboro Blend No. 54, those days are just beginning.

The only difference is that now, these menthol brands have the blessing of the health groups and of our federal government.

It's difficult to believe that this dishonest communication by the ACS was simply a mistake, since previous communications from the ACS did mention that menthol was exempt. Given the publicity that issue has received in recent weeks, I find it very difficult to believe that this wasn't a deliberate act of deception on the part of the ACS to make the bill sound better than it is and to hide the fact that the legislation fails to address the very issue which the ACS stated was so critical in its special report. Telling the truth would have forced the ACS to admit that the bill was largely a political show - window dressing - and that its propaganda is covering up the fact that the bill protects, rather than reduces, sales of the very products which are most responsible for addicting millions of our nation's youths.

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Monday, June 22, 2009

Philip Morris Boasts About Its Concern for Health Issues and the Highest of Standards, Becomes New Hero of Anti-Smoking Movement

In today's column by Jacob Sullum in Reason Online magazine's Hit & Run blog, Sullum comments on the public relations bonanza achieved by Philip Morris through its massive achievement of convincing the anti-smoking groups to stand shoulder-to-shoulder with it in promoting the FDA tobacco legislation, which President Obama signed into law earlier this afternoon. Sullum jokingly (but not really) refers to Philip Morris as the new hero of the anti-smoking movement.

Playing up to that role, Philip Morris has issued a statement in which it boasts about its concern for health issues and its commitment to high standards. Its executive vice president writes that: "Altria and Philip Morris USA have supported federal regulation of tobacco products by the Food and Drug Administration for nearly a decade -- and with good reason. Fundamentally, we cannot ignore the health issues associated with tobacco use and their implications for consumers and society as a whole. ... We believe that a comprehensive regulatory framework, implemented thoughtfully, can provide significant benefits to tobacco consumers. These benefits include establishing a common set of high standards for all tobacco manufacturers and importers doing business in the U.S., providing a framework for the evaluation of tobacco products that are potentially less harmful than conventional cigarettes, and creating clear principles for accurate and scientifically grounded communication about tobacco products to consumers."

The Rest of the Story

Ironically, it is the Campaign for Tobacco-Free Kids and the other anti-smoking groups which supported this legislation that made Philip Morris a hero of the anti-smoking movement. And, as I revealed earlier today, Dr. David Kessler even went so far as to heap praise upon Philip Morris.

By agreeing to negotiate with Philip Morris, by reaching a deal with Philip Morris, and by forming an alliance with Philip Morris to push forward legislation that Philip Morris helped craft to regulate its own products in its own preferred way, the anti-smoking groups have legitimized this tobacco company and made it a legitimate public health entity. Yes, Philip Morris is - thanks to its friends at the Campaign for Tobacco-Free Kids - a hero in the anti-smoking movement.

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FDA Recalls Prepackaged Nestle Toll House Cookies and Several Brands of Electronic Cigarettes; Takes No Action on Existing Conventional Cigarettes

Here are two recent press releases from the FDA: one real and one hypothetical, but unfortunately, not too far from the truth.

FDA NEWS RELEASE
#1

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167908.htm

For Immediate Release: June 19, 2009

Media Inquiries: Michael Herndon, 301-796-4673, michael.herndon@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA Warns Consumers Not to Eat Nestle Toll House Prepackaged, Refrigerated Cookie Dough

Nestle Voluntarily Recalls all Varieties of Prepackaged, Refrigerated Toll House Cookie Dough

The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness).

The FDA advises that if consumers have any prepackaged, refrigerated Nestle Toll House cookie dough products in their home that they throw them away. Cooking the dough is not recommended because consumers might get the bacteria on their hands and on other cooking surfaces.


FDA NEWS RELEASE #2

For Immediate Release: June 19, 2009

Consumer Inquiries: 888-INFO-FDA

FDA Assures Consumers It's OK to Smoke Philip Morris, R.J. Reynolds, and Lorillard Cigarettes But Not Ruyan's or Other Companies' Electronic Cigarettes

The U.S. Food and Drug Administration is assuring consumers today that there is no cause for alarm over any varieties of prepackaged cigarettes manufactured by the largest tobacco companies, despite the confirmation that these products contain more than 10,000 chemicals, including at least 60 known carcinogens and that they are causing more than 400,000 deaths each year in the United States alone.

The FDA is not taking any of the actions that it usually takes against food and drugs when they have been confirmed to cause death, including any of the following:

1. The FDA is not recalling the product.
2. The FDA is not pulling the product off the market.
3. The FDA is not restricting the places where the product can be sold.
4. The FDA is not requiring the removal of the toxic chemicals and carcinogens from the product.

The FDA advises that if consumers have any prepackaged, Philip Morris, R.J. Reynolds or Lorillard products in their home that they not throw them away. The FDA is prepared to take action if there is any adulteration or unexpected contamination that makes cigarettes unacceptably dangerous. But at the current level of danger, there is no need to take further action.

The FDA is also working hard to ensure that new tobacco products introduced into the market have been proven to be safe. But the FDA says there is no need to apply those high standards to the current products which are killing hundreds of thousands of smokers each year. "We don't care if smokers are dying from current products," stated an FDA spokesperson who declined to be named. "We just don't want them dying from new products."

At the same time that the FDA is failing to take action against conventional cigarettes with their more than 10,000 chemicals and 60 carcinogens plus nicotine, the FDA has pulled from the market several varieties of electronic cigarettes which deliver just nicotine without the other 10,000 chemicals and 60 carcinogens.

According to an FDA spokesperson: "We are acting with an abundance of caution. We have no idea what the health effects of inhaling just nicotine is in the absence of the 10,000 other chemicals and the carcinogens. With conventional cigarettes, at least we know what's going to happen. At least 400,000 people will die. We feel comfortable because we know the consequences. But with electronic cigarettes, we have literally no idea."

Health groups applauded the FDA's decision to issue a warning about electronic cigarettes and take that product off the market while keeping conventional cigarettes on the market with no further restriction on the age of sale, places where they can be purchased, or required removal of the toxic chemicals. The Campaign for Flavor-Free But Menthol-Full Kids stated: "At least with conventional cigarettes, we know what we're dealing with. We know we're going to have upwards of 400,000 deaths. But with electronic cigarettes, there is no absolute proof that they are safer. There is no assurance that removing the more than 10,000 chemicals and 60 carcinogens from tobacco smoke and just leaving the nicotine is going to lead to any improvement in health of the users of these products. We advise smokers not to switch to electronic cigarettes until there is clear proof, through long-term studies, that these products are safer. Please, stick with the conventional cigarettes. We can't tolerate the even slight chance of harm from this new product. We have to act from an abundance of caution."

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Dr. David Kessler Congratulates Philip Morris VP on FDA Legislation, Telling Him He Was Instrumental to the Bill's Success, and Praises Philip Morris


This Confirms that Alliance Between Public Health and Big Tobacco Led to FDA Tobacco Legislation

Kessler Admits that Legislation is Basically a Hoax in that There is No Intention or Expectation that FDA Regulation Will Lead to a Safer Product

Kessler's Praise of Philip Morris is Devastating Blow to Public Health and Huge Victory for Philip Morris

According to an article in the New York Times, former FDA head and current anti-smoking advocate Dr. David Kessler sent a message to recently retired Philip Morris senior vice president Steven Parrish congratulating him on the passage of the FDA tobacco legislation and praising him for his instrumental role in making the bill's enactment possible. Kessler wrote to Parrish: "Congratulations to you — you were key."

On NPR's Weekend Edition, Dr. Kessler publicly heaped praise upon Philip Morris and emphasized that public health and the largest element of Big Tobacco now see eye-to-eye and stand shoulder-to-shoulder in their desire to protect the health of the nation's children and adults.

Kessler told NPR: "I applaud Mr. Parrish's efforts. ... I think he deserves a lot of credit in making this shift. We agree on the legislation and I think that's what's important."

Interestingly, despite the bill's primary stated intention of making cigarettes safer by giving FDA the authority to regulate the design and consitituents of the product, Kessler admitted that it was neither the intention nor the expectation of the bill's supporters that the bill actually achieve this purpose. He readily admitted that there is no scientific way for the FDA to make the product safer -- it's not even possible, he said:

"I'm not sure that scientifically we're smart enough to know how to do that or that's possible when you're burning a tobacco leaf or you're inhaling all these chemicals that are very reinforcing."

According to the New York Times article, Philip Morris was "critical in making cigarette regulation come to pass." The article also made it clear that thanks to the Campaign for Tobacco-Free Kids' overwhelming zeal to get some bill passed, Philip Morris was given a seat at the negotiating table and played a role in crafting the bill as the specific provisions were hashed out: "For sure, it [the Campaign for Tobacco-Free Kids' willingness to negotiate with Philip Morris] meant that Altria would have a seat at the table as the bill was being hashed out."

The Rest of the Story

Can you imagine? A chief public health and anti-smoking advocate is publicly praising Philip Morris for its support of public health!

While this shows that I was correct in my prediction that passage of this legislation would bring immense public relations benefits for Philip Morris, my opinion had been based on a belief that the company would create its own PR. I never imagined that public health advocates would create that public relations for Philip Morris by heaping praise upon the company for supporting public health.

This is truly a dream-come-true for Philip Morris. It now stands shoulder-to-shoulder with the public health community in the public light, and health advocates are making that happen. From what Dr. Kessler told the public, you would think that Philip Morris is now an equal partner in the movement to protect the public from the harms of tobacco. They are to be praised for their support of public health and they are now part of an alliance that sees eye-to-eye on federal tobacco policy.

Philip Morris could not possibly have even dreamed about such a public relations bonanza!

Dr. Stanton Glantz - a long-time tobacco control researcher and advocate - argued last week that the bill is a deal between the Campaign for Tobacco-Free Kids and Philip Morris and that one of the most damaging aspects of the legislation is that it legitimizes the tobacco industry, undermining years of public health progress: "'Basically, the public health people cut a deal with Philip Morris.' ... Glantz argues that the legislation legitimizes the tobacco industry at a time when 'legitimacy was being lost.'"

Dr. Kessler's remarks were incredibly revealing not only because he confirmed the alliance between public health and the largest company within Big Tobacco and the role of this alliance in making the FDA legislation possible, but also because he essentially confirmed that the bill is a huge hoax.

Dr. Kessler openly admitted that he has no expectation that the FDA will be able to make cigarettes safer. He said that it may not even be possible for the FDA to make cigarettes safer.

Well if that's the case, then the FDA is going to be approving cigarettes that are going to continue killing 400,000 or more people per year. Thus, FDA regulation is not going to make the product safer. All it will do, according to Kessler himself, is to allow the tobacco companies to continue to kill 400,000 people a year, except now with the government's official approval.

In other words, there are still going to be 400,000 deaths a year from cigarettes, and the bill's supporters know it, but they are instead telling the American people that the bill is going to save millions of lives by making cigarettes safer because FDA can take certain toxins out. But there is no expectation that is even possible, according to Kessler.

The end result is that cigarettes will continue to kill hundreds of thousands of Americans each year, except now they will be killing us with the blessing of the federal government and the public health groups. As a MarketWatch article predicts, FDA regulation will "make Big Tobacco even bigger."

The FDA tobacco legislation is a hoax because the politicians and health groups supporting the legislation have been telling the public that under this bill, the FDA will make cigarettes safer by removing certain of the toxic ingredients from the product. Now we find out from Kessler himself that there is no expectation that cigarettes will be made safer and that he doesn't even believe it is possible that removing certain ingredients will make cigarettes safer.

It truly is a hoax. And a hoax of massive proportions, I would add.

Just look at what supporters of the legislation are telling the American people. Senator Christopher Dodd (D-CT) boasted that because of this legislation, cigarette manufacturers will "be forced to stop using some of the most dangerous ingredients." As if that makes any difference. There are more than 10,000 chemicals in cigarettes and there is no evidence that removing "some" of the most dangerous ones will result in a safer product. But this scientific fact did not stop Senator Dodd from pulling the wool over the eyes of the public and contributing to the public hoax.

Even worse, look at what Senator Kennedy told the American public. He boasted that the legislation will "help addicted smokers quit" and that it will "require manufacturers to make tobacco products less toxic and less addictive for those who continue to use them." But the legislation does nothing to help addicted smokers quit. There is no support of smoking cessation programs. There is no money for smoking quitlines or any inteventions that will help smokers quit. There are no funds for campaigns to motivate smokers to quit. In fact, the only relevant power the bill gives the FDA is to reduce nicotine levels in cigarettes. However, we know from the scientific evidence that this will just result in smokers smoking more not less, as they need to compensate to maintain a constant dose of nicotine.

As John Jonik points out in a letter to the editor in the Seattle Times, Senator Kennedy's false promise is merely a continuation of the tobacco industry's fradulent statements about the benefits of low-nicotine cigarettes. In fact, Senator Kennedy's claim is probably worse because while the tobacco companies merely implied that "light" cigarettes might be less addictive, Kennedy is clearly asserting that low-nicotine yield products will be less addictive. Why is it that the tobacco companies were found guilty of fraud for making the same statement (in an even less assertive way) that Kennedy is now making?

Senator Kennedy's assertion that the bill will require manufactureres to make tobacco products less toxic is also false - another hoax. As Dr. Kessler admitted, there is no expectation that FDA regulation of certain of the ingredients in tobacco will be able to make cigarettes safer. Senator Kennedy, too, is pulling the wool over the eyes of the American public.

Another important implication of this story is that it confirms, based on reliable inside sources, that the Campaign for Tobacco-Free Kids has lied to its constituents and the public about the true role of Philip Morris in these negotiations. The Campaign has led us to believe that Philip Morris played little to no role in crafting the legislation and that its support for the legislation was essentially a coincidence -- they just happened to support the legislation that happened to come out of Waxman and Kennedy's offices.

Now we have quite reliable confirmation from inside sources that Philip Morris indeed played a critical role in the process. Philip Morris had a seat at the negotiating table. Philip Morris' support was deemed critical to the bill's passage. Philip Morris was involved in the crafting of the legislation as it was hashed out, and the companies' acceptance of the specific provisions of the bill was apparently viewed as essential to the bill's success.

In other words, the legislation represents a secret back-room deal between the Campaign for Tobacco-Free Kids ("representing" the public health community) and Philip Morris.

This is absolutely not the story that the Campaign for Tobacco-Free Kids has been telling, and it is obviously not what the Campaign wanted us to find out.

Even R.J. Reynolds confirmed that Philip Morris had a role in crafting the legislation: "R.J. Reynolds said one of its early objections to the legislation was that Philip Morris had a role in crafting it."

There can be no more denials by the Campaign and the other health groups. It is eminently clear what happened. It was the support of Philip Morris for the legislation that was the critical factor that made this bill possible. And therefore, Waxman and Kennedy deemed that the provisions in the bill would have to be approved by Philip Morris first, to make sure that the company would still support the legislation. That was why Philip Morris was invited to the table! There would have been no other reason to invite Philip Morris to the table unless Kennedy and Waxman needed a gauge as to how Philip Morris would treat the various provisions in the bill. Could Philip Morris live with these provisions or not? That -- and not the extent of protection of the public's health -- was the key factor that determined the final look of the legislation.

And alas, this is why it is nonsensical for Kessler to praise Philip Morris. The opportunity to be governed by a regulatory framework that you help to design is a dream-come-true for any corporation. It is not some sort of sacrifice that Philip Morris made because it has the health of the public as its concern.

Regulation does not equate to a loss of sales and profits. Regulation does not translate into reduced consumption of a product. What regulate actually means is "to permit." You are permitting the product to be sold, with some restrictions. The key thing is not whether the product is regulated, but how it is regulated and the extent of restrictions placed on the regulator. In this case, Philip Morris' seat at the table ensured that those restrictions would be heavy and that the regulation would never substantially endanger actual tobacco sales or profits.

Other companies would just dream of being given the opportunity to write the law that would govern their own regulation. In some cases, that has occurred, and where it has, it has led to the inability of regulators to properly protect the public's health. In this case, the fox was not only guarding the henhouse, the fox was allowed to write the regulations concerning the guarding of the henhouse.

Late last week, Dr. Stanton Glantz criticized the legislation specifically because it allows the fox to guard the henhouse. As Glantz pointed out, "The bill creates a 12-member advisory board through which all regulations will flow. Tobacco industry representatives will hold three nonvoting seats. 'Putting three guys on this committee would be a little bit like putting three mobsters on the Department of Justice committee on organized crime,' Glantz said, echoing the sentiment of other strong tobacco-control advocates."

This represents an unprecedented special protection for Big Tobacco (rather than ending special protections for Big Tobacco, as the Campaign for Tobacco-Free Kids claims in its propaganda).

Can you imagine if Merck had been allowed to sit on the FDA panel that was considering whether or not to take Vioxx off the market? Can you imagine if Pfizer were allowed to sit at the FDA table as it considers whether Chantix is causing severe adverse effects and whether special warnings or stronger actions - such as removal from the market- are required?

The rest of the story is that the FDA tobacco legislation is a successful hoax played on the American people by an alliance of health groups, politicians, and the nation's largest tobacco company. It was largely crafted by Philip Morris. It was a Congressionally-mediated deal struck between the Campaign for Tobacco-Free Kids and Philip Morris. The support of Philip Morris was deemed critical and Waxman, Kennedy, and the Campaign allowed Philip Morris to have a seat at the table because its approval of the details of the legislation was essential: otherwise, the company's support for the legislation would not be ensured. The result is a bill that contains numerous provisions that tie FDA's hands, give unprecedented special protections to Big Tobacco, and create a package that allows politicians and health groups to tell the public that they are really doing something to make cigarettes safer and to cut smoking rates when the truth is that they are aware that the bill will not make cigarettes safer and its provisions do not allow FDA to take the actions that would be necessary to substantially cut smoking rates.

The ultimate, and most ironic, truth is that in heaping praise upon Philip Morris, Dr. Kessler is acting as a great friend to Big Tobacco, and not as an anti-tobacco advocate as we have come to know him. He has single-handedly given Philip Morris the legitimacy and positive public image as a socially responsible and health-concerned corporation that it so deeply craves. He has undermined years of public health efforts to portray the tobacco companies in the negative light that they deserve for their long history of actions that have undermined the public's health.

But it's not all Dr. Kessler's fault. The Campaign for Tobacco-Free Kids really made this all possible, and essentially set up Dr. Kessler for this grave mistake, by agreeing to the secret negotiations with Philip Morris in the first place, without inclusion or representation of anyone else in the public health community who might have had a broader and more enlightened viewpoint.

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Friday, June 19, 2009

Newspaper Columns Call FDA Legislation What It Really Is: A Scam

Three more newspaper columns have exposed that the FDA tobacco legislation is actually a public scam in which politicians and health groups pat themselves on the back for taking on Big Tobacco when in reality, they have granted unprecedented special protections to the industry and failed to take the meaningful action that would actually make a dent in cigarette smoking rates.

While it is reassuring to see that the public is finally being made aware of the truth behind this legislation, it is unfortunate that this education comes after the legislation has already been enacted and it is too late for Congress and the health groups to re-think the damage they have done. But that's what happens when the leading organization (the Campaign for Tobacco-Free Kids) behind the bill's idea of discussion and inclusion is holding a conference call to allow itself to spread the propaganda under the guise of "answering questions" about the bill.

1. Philadelphia Inquirer Editorial

An editorial in the Philadelphia Inquirer stated that the FDA legislation was "a pact with the devil." It opined that the institutionalization of nicotine into cigarettes was a huge victory for Big Tobacco and that the FDA seal of approval will give the companies a public relations bonanza, allowing them to use attractive slogans such as "I'd walk a mile for an FDA-approved Camel."

The editorial states: "As Congress and President Obama move closer toward bringing tobacco products under federal oversight for the first time, they have to wonder if they're also making a pact with the devil. ... By agreeing to support federal regulation, tobacco giant Philip Morris U.S.A. assured that addictive nicotine would never be banned - a huge victory. Beyond that, however, the industry stands to gain an implicit stamp of approval by marketing its products under the watchful gaze of the FDA, whose usual mission is to assure that food and medicines are "safe and effective." It's not too far-fetched to imagine the ad campaigns: I'd walk a mile for an FDA-approved Camel."

2. Congress Examiner Column

A column by Igor Derysh in the Congress Examiner called the FDA legislation a "cheap political ploy" that allows politicians to tell the American public that they did something about the problem when they actually did nothing to actually make a difference in smoking, other than perhaps get rid of the banana-flavored cigarettes that are such a pervasive problem. Noting that the bill gets rid of all the flavorings that are not used but exempts the one flavoring (menthol) that is actually used to addict thousands of young people, Derysh concludes: "Protecting the public, my ass."

Derysh writes: "Earning cheap political points by going after easy targets has always been high on Congress' agenda. Respecting the American public has not. And so, when the recent tobacco regulation bill passed overwhelmingly in Congress it was both a cheap political ploy and another example of Congress disregarding the possible intelligence of the American people. The bill itself transferred regulation of the tobacco industry to the Food and Drug Administration (a government agency that is run by the same people that it regulates), strengthens warning labels, demands that tobacco companies disclose their ingredients, and bans flavored cigarettes. All flavored cigarettes except for menthol cigarettes. Menthol cigarettes of course have a considerably higher amount of harmful chemicals than others do and are targeted towards the black community just like guns. Protecting the public, my ass."

"The passage of the Tobacco Control Act is just another attack on the intelligence of the American individual. We do not need to be told that cigarettes are bad for you, we are bombarded with that message all day long. What we need is a Congress that accomplishes something worthwhile or just stays the hell home instead of celebrating cheap victories in which they banned banana flavored cigarettes."

3. Op-Ed in New York Post

George Will's column in the New York Post similarly opines that the FDA legislation is just another example of politicians patting themselves on the back when they have actually strengthened the position of Philip Morris, rather than taken meaningful action to protect the public's health.

Will writes: "Politicians have extraordinary shoulder joints that enable them to pat themselves on the back. Last week the president, a master of that calisthenic, performed it in the Rose Garden. His subject was the bill by which Congress authorized the Food and Drug Administration to regulate tobacco. The president called this "a bill that truly defines change in Washington" and "changes the way Washington works and who Washington works for." Our leaders are often wrong but rarely so precisely wrong." ... the bill is a crystalline example of Washington business as usual -- the protection of the strong. The bill was supported by America's biggest tobacco company ... Although commercial speech doesn't receive full First Amendment protection, Congress shouldn't be allowed to effectively prohibit truthful communication about a legal product. Philip Morris, however, can live -- indeed, can flourish -- with the new restrictions on the marketing measures by which less powerful companies might threaten its dominance. ... Government policy regarding tobacco, as regarding so much else, is contradictory and unlovely. ... Ironies abound. The February expansion of the State Children's Health Insurance Program is supposed to be financed by higher tobacco taxes, so this health care depends on an ample, renewable supply of smokers. State governments, increasingly addicted to tobacco-tax revenues, face delicate price calculations: They want to raise their regressive tobacco taxes (smokers are disproportionately low income and poorly educated) to just below where smokers are driven to quit. Governments can't loot tobacco companies that don't flourish."

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Thursday, June 18, 2009

The Next Fallout from FDA Tobacco Legislation: Virtual Immunity for Big Tobacco

An article published Monday in Lawyers USA reveals that the FDA tobacco legislation will have a devastating effect on litigation against the tobacco industry because it will all but remove the prospect of punitive damages in these cases.

According to the article: "A bill that will give the Food and Drug Administration the authority to regulate tobacco products could make it harder for plaintiffs to obtain punitive and equitable remedies in tobacco cases. ... 'I’m sure companies will try to wrap themselves with the cloak … of being regulated by the FDA, and given that fact, punitive damages might be minimized,' said Edward Sweda, senior attorney for the Tobacco Products Liability Project at Northeastern University School of Law in Boston." ...

"If the FDA establishes more stringent rules for tobacco companies governing the marketing, warning labels and even the contents of tobacco products, it could become more difficult for plaintiffs to punish tobacco companies for practices that are allowed under such a tightened regulatory environment, lawyers said. In a statement after the bill passed the Senate, Altria Group, the parent company of Philip Morris, said that the new law will “establish a regulatory structure and standards for the manufacturing and marketing of tobacco products” - a hint that once the FDA sets these standards, it will argue that tobacco companies can’t be punished as long as they adhere to them. As a result, it might be harder for plaintiffs to obtain punitive damages in tobacco cases. The new law could also make it tougher for litigants to force tobacco companies to change their practices. 'Efforts by state attorneys general to try to further enforce the master settlement agreement or to take up regulatory action to try to get a court to crack down on particular practices in the industry will be affected, if the particular practice is already covered by the FDA regulations,' Sweda said."

The Rest of the Story

This story reveals yet another reason why the FDA tobacco legislation is a victory for Big Tobacco and a dream come true for Philip Morris. By virtue of FDA regulatory authority over tobacco products, the cigarette companies will be able to effectively argue that there is no further need for punitive damages, since the FDA can now regulate tobacco advertising, production, design, constituents, ingredient disclosure, etc. And the very low prospect for punitive damages will severely limit the pool of lawyers willing to take on these cases. Most importantly, it will eliminate the potential for any seriously damaging class action lawsuits, like Engle and Broin, which resulted in a huge verdict and a huge settlement, respectively, specifically because of the possibility for large punitive damage awards.

For this reason, the legislation effectively ends the threat of major financial damage from litigation for the industry. Thus, it gives Big Tobacco the gift of virtual immunity.

True, the industry may still need to pay out some individual smokers in terms of compensatory damages. However, this is pocket change for the industry and the slow stream of these cases poses no serious threat. Moreover, the industry is now able to use its vast resources to exhaust the resources of individual plaintiffs. We will see a return to the days when the tobacco industry almost never lost a case.

For all intents and purposes, the FDA tobacco legislation has ended the use of litigation as an effective tool for public health change in tobacco control. This is a devastating loss for the tobacco control movement, since it was in the courtroom that the movement realized some of the most important victories in the past decade and a half.

Another day. Another revelation about the devastating damage that the FDA tobacco legislation has done to the tobacco control movement and to the protection of the public's health.

It's just a shame that the public is only finding out about this after the fact. It would have been nice if our anti-smoking and health organizations had been honest with us up front. Now it's becoming clear why these groups had to lie to us to get the legislation passed. Telling the truth would have killed the bill. No wonder the Campaign for Tobacco-Free Kids was incapable of honest communication on the bill and needed to resort to a massive campaign of deception.

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Wednesday, June 17, 2009

FDA Tobacco Bill Itself Admits that It is a Scam

In passing the FDA tobacco legislation, bill supporters have themselves acknowledged that the legislation is a scam and that FDA regulation does not and will not make cigarettes safer.

In the bill itself, supporters have acknowledged that: "If manufacturers state or imply in communications directed to consumers through the media or through a label, labeling, or advertising, that a tobacco product is approved or inspected by the Food and Drug Administration or complies with Food and Drug Administration standards, consumers are
likely to be confused and misled. Depending upon the particular language used and its context, such a statement could result in consumers being misled into believing that the product is
endorsed by the Food and Drug Administration for use or in consumers being misled about the harmfulness of the product because of such regulation, inspection, approval, or compliance."

The Rest of the Story

In acknowledging that FDA regulation does not and will not in fact make cigarettes safer, the bill's supporters have revealed to us that this is a scam: on the one hand, we are being told that the FDA is going to take the toxic constituents out of cigarettes. On the other hand, supporters have acknowledged - in the bill itself - that FDA regulatory standards will not create a safer product.

Because of this concern that the public might actually believe the bill's supporters that the regulation of the product by the FDA will make it safer, combined with the fact that the bill's supporters understand that what they are telling the public is untrue, the supporters have snuck a provision into the bill which prohibits the tobacco companies (but not politicians and health groups) from even telling consumers that the FDA regulates tobacco products and that the companies are in compliance with FDA standards.

The bill prohibits tobacco companies from "making any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that ... the product is safe or less harmful by virtue of its regulation or inspection by the Food and Drug Administration or its compliance with regulatory requirements set by the Food and Drug Administration."

The bill's supporters have - above - acknowledged that if manufacturers simply state that they comply with FDA standards, consumers are likely to be misled into believing that the products are safer. Thus, the bill effectively prohibits companies from even telling their consumers that they comply with FDA standards.

On top of being unconstitutional as it violates the free speech rights of these companies by prohibiting the communication of truthful information, this provision exposes the legislation for the scam that it is. The bill's supporters have told their constituents and the American public that the bill will lead to the elimination of toxic constituents from tobacco. Within the fine print of the bill, however, they have admitted that the bill will not lead to a safer cigarette and that if cigarette companies even mention to their customers that they are complying with FDA standards, those consumers will be misled.

Is it not also true, then, that the public health groups supporting this legislation are misleading the public by stating that tobacco companies will be forced to comply with FDA standards?

Over time, the public is going to come to appreciate the scam that this really is. Unfortunately, Congress only entertains federal tobacco policy about once every 30 years, so it is very unlikely that they will soon fix the public health mess that they have created.

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Tuesday, June 16, 2009

Constitutionality of FDA Tobacco Legislation is Already Being Challenged; First Amendment Lawsuit Almost Certain

According to an article in yesterday's New York Times, a constitutional challenge of the FDA tobacco legislation - based on the First Amendment - is almost a certainty. The advertising industry, tobacco companies, and the ACLU have all challenged the constitutionality of the legislation's advertising restrictions, hinted that lawsuits are pending, and predicted that the restrictions will largely be overturned by the Supreme Court.

According to the article: "The law’s ban on outdoor advertising within 1,000 feet of schools and playgrounds would effectively outlaw legal advertising in many cities, critics of the prohibition said. And restricting stores and many forms of print advertising to black-and-white text, as the law specifies, would interfere with legitimate communication to adults, tobacco companies and advertising groups said in letters to Congress and interviews over the last week. ... Opponents of the new strictures, including the Association of National Advertisers and the American Civil Liberties Union, predict that federal courts will throw out the new marketing restrictions. They say, for example, a 2001 Supreme Court decision struck down a Massachusetts rule that had imposed a similar ban on advertising within 1,000 feet of schools."

The article points out: "In the 2001 case, the Supreme Court struck down a Massachusetts ban on tobacco ads, including outdoor billboards and signs that could be seen within 1,000 feet of any public playground and elementary or secondary school. That ban, which would have eliminated tobacco advertising in about 89 percent of Boston, is virtually identical to one standard in the new federal law. The Supreme Court found it to be an unconstitutional limit of the First Amendment right to free speech in part because it was simply too broad. The effect 'will vary based on whether a locale is rural, suburban, or urban,' Justice Sandra Day O’Connor wrote for the majority. 'The uniformly broad sweep of the geographical limitation demonstrates a lack of tailoring.'"

The Rest of the Story

There are two aspects of the legislation that are likely to be challenged on First Amendment grounds. First is the bill's advertising restrictions. Second is the bill's restrictions on truthful information that the tobacco companies are permitted to communicate to their customers.

The bill's advertising restrictions are unlikely to be upheld by the Supreme Court because the Court has already struck down very similar regulations that were issued in Massachusetts. Here, the state imposed a ban on smokeless tobacco advertising within 1000-feet of schools and playgrounds, which is identical to one of the major advertising restrictions in the FDA legislation. The Supreme Court struck down those restrictions, ruling that they violate the First Amendment's protection of free speech rights of the tobacco companies.

As a Congressional Research Service analysis explains the decision: "The Court determined that the regulations restricted speech more than was reasonable to advance the state’s interest in reducing underage (i.e., illegal) use of tobacco products and, thus, failed to meet the fourth part of the Central Hudson test. Banning all outdoor tobacco advertisements within 1,000 feet of a school or playground, in conjunction with other zoning restrictions, argued the Court, “would constitute a nearly complete ban on the communication of truthful information about smokeless tobacco and cigars to adult consumers.” The Court found that the restrictions on outdoor advertising of cigars and smokeless tobacco were overbroad in that they prohibited advertising “in a substantial portion of the major metropolitan areas of Massachusetts,” included oral communications, and imposed burdens on retailers with limited advertising budgets. The Court also upheld challenges by smokeless tobacco and cigar companies to the outdoor advertising restrictions on the grounds that adults have a right to information and the tobacco industry has a right to communicate truthful speech on legal products."

The Campaign for Tobacco-Free Kids and other health groups have been misleading their constituents and the public about the likely effect of the legislation on cigarette advertising, because these groups have not been honest with us about the fact that the bill's advertising restrictions are almost certainly going to be challenged in court and the fact that very similar restrictions were overturned by the Supreme Court in 2001.

When all is said and done, the effect of the legislation's remaining advertising restrictions is likely to be quite minor.

The second aspect of the legislation which will almost certainly be challenged in court is the bill's prohibition on cigarette companies making truthful statements about FDA regulation of tobacco products. The House version of the bill prevents companies from even stating that FDA regulation of tobacco products exists, while the Senate version prevents companies from making any statement that could be implied as suggesting that the FDA approves cigarettes for sale and consumption. In both cases, the constitutionality of the legislation is doubtful because it prevents companies from making truthful statements and therefore is likely in violation of their First Amendment free speech rights.

Jonathan Adler points out the absurdity of this aspect of the legislation: "One fear of tobacco-control activists is that cigarette companies would trumpet FDA approval, giving consumers the impression that cigarettes and other tobacco products are safe — or at least “safer” — now that the FDA is involved. To address this concern, the bill prohibits “any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that the product is approved by the Food and Drug Administration,” or was somehow deemed “safe” by the federal government. So while the FDA will now have the final say over what tobacco products may be on the market, federal law will purport to prohibit companies from saying so, lest consumers be “misled” into believing FDA regulation of tobacco is for their benefit."

Supporters of the FDA legislation are trying to have it both ways. On the one hand, they're trying to argue that cigarettes are going to be made safer by virtue of FDA regulation, thus reducing health risk and saving millions of lives. On the other hand, they don't want cigarette companies to tell the public that the FDA regulates cigarettes because they are afraid that the public might wrongly infer that cigarettes are going to be made safer by virtue of FDA regulation, thus reducing health risk and saving millions of lives.

Now you can see why I call this a scam.

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Saturday, June 13, 2009

Praise of FDA Tobacco Bill by President Obama, Representative Waxman, and New FDA Chief Countered by Rest of the Story Author in Reuters News Story

It looks like it was lowly me being left to counter President Obama, Representative Waxman, and new FDA-chief Margaret Hamburg in their praise of the FDA tobacco legislation and how it is going to create safer cigarettes, keep tobacco out of the hands of youths, and save lives.

The Reuters news article is here.

The key thing, however, is that we are succeeding in getting the "rest of the story" out there. Due to our aggressive media outreach this past week (and I am grateful to the communications offices and staff at Boston University and the BU School of Public Health for all of their help), we succeeded in getting our version of the story out there. While it doesn't dominate the media coverage, at least this alternative perspective is presented and considered, and the public is hearing that there is, in fact, another side to the story.

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Friday, June 12, 2009

My Interview on NPR's All Things Considered

Click here to listen to this segment about the FDA tobacco legislation.

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The Ultimate Insanity: Health Groups Want to Remove Some Toxins from Cigarettes, But Want to Ban Product Which Already Removed Virtually All of Them

The Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, and American Lung Association have supported the legislation, about to be enacted, which asks the FDA to make cigarettes safer by removing certain of the more than 4,000 known constituents in the tobacco smoke.

At the same time, these groups have asked the FDA to ban a product (electronic cigarettes) which has already been developed and which already has eliminated all of the 4,000 known constituents in tobacco smoke, other than the nicotine.

I can't help it, but this is the ultimate in insanity.

Why would you put your heart and soul into a a piece of legislation that, at very best, will allow the FDA to remove a few of the constituents from cigarette smoke but at the same time, demand that a product which has succeeded in removing all (but nicotine) of these constituents be immediately taken off the market?

This makes absolutely no sense.

It exposes the unfortunate fact that for these particular health groups, it just isn't about the actual health of the public any more. It seems to me that these groups are more interested in achieving political victories which they might use to charge up their constituents and solicit more donations than in actually supporting policies that will make substantive contributions to the public's health.

There is no way that the FDA, even after many years of research and deliberation, will be able to come up with regulations that produce a product that is anywhere near as safe as the electronic cigarette. The FDA can ponder all it wants about which few constituents it makes sense to remove from cigarettes, but the electronic cigarette has removed all of them, other than the nicotine. So if we already have a product that has achieved far more than the FDA ever will in terms of the search for a safer cigarette, then why on earth would these "health" groups want to ban such a product?

This is, frankly, the most absurd situation I have ever observed in my public health career.

Rather than risk the slight possibility that perhaps the propylene glycol exposure from e-cigarettes has some unknown, long-term health effects, the health groups would rather that smokers continue to smoke the highly toxic alternatives (a.k.a., conventional cigarettes) and that the much safer electronic cigarette option be taken away from them.

Contrary to what the public health groups have claimed, the FDA legislation is not going to save millions of lives. Instead, these hypocritical and misguided actions by the health groups are going to cost countless lives, as electronic cigarette smokers are essentially forced to go back to smoking the much more hazardous conventional counterparts.

And meanwhile, the FDA can begin pouring countless resources into its ill-fated effort to produce a safer cigarette by removing a few of the more than 4,000 known constituents.

All for a small political victory for these health groups.

It's a travesty that the actual protection of the health of the public is no longer the paramount concern of these groups.

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Senator Kennedy's Statement Shows that the Chief Author of the FDA Legislation Has Crafted a Complete Scam on the American People

In a statement released to coincide with the passage of a bill which he helped to craft, along with Philip Morris and the Campaign for Tobacco-Free Kids, Senator Ted Kennedy stated the following regarding the role of this legislation in protecting our nation's children from addiction:

"It is a life saving act for the millions of children who will be spared a lifetime of addiction and premature death. ... passage of H.R. 1256 is the most important action Congress can take to protect children from this deadly addiction. ... More than forty million people are hooked on this highly addictive product and many of them have been unable to quit despite repeated attempts. However, FDA action can play a major role in breaking the gruesome cycle that seduces millions of teenagers into a lifetime of addiction and premature death. ... What can FDA regulation accomplish? ... It can help smokers overcome their addiction. It can make tobacco products less toxic and less addictive for those who continue to use them. ... FDA must have the authority to reduce or remove hazardous and addictive ingredients from cigarettes, to the extent that it is scientifically feasible. The inherent risk in smoking should not be unnecessarily compounded."

The Rest of the Story

The rest of the story is that Senator Kennedy's statement reveals that he is full of crap.

As I have explained in detail previously, the legislation precludes the FDA from removing the nicotine from cigarettes. It does not protect kids or adults from addiction. It does not make it easier for adults to stop smoking. It does not make it more difficult for the tobacco companies to addict children. It does not give the FDA the authority to remove the chief addictive ingredient from cigarettes, as Kennedy says is mandatory. It does not eliminate the unnecessary compounding of the inherent risk in smoking by the addition of an addictive chemical.

While I could excuse a Senator for supporting legislation that precludes the FDA from eliminating nicotine, it is inexcusable - in my view - for a politician to support such a bill and then to have the political gall to get up in front of the American people and tell them that he has done something to protect future generations of children from addiction and to help millions of smokers to quit.

The bill does neither of these two things. In fact, it does the opposite. It institutionalizes nicotine. It ensures that nicotine will always remain in cigarettes. It protects nicotine from removal from tobacco products, ensuring that the tobacco companies will always maintain the power to addict new generations of customers (i.e., youths).

If there is anything that this bill does not do, it is protect future generations of children from nicotine addiction, as Senator Kennedy has told the American people it does.

It is very sad for me to see the depths to which politicians will apparently sink in order to obtain political gain. It is very clear that it is politics which is the primary concern - being able to say that you did something to confront Big Tobacco. But the actual substance of the policy doesn't matter. The actual effect on the ability of Big Tobacco to addict future generations is not important. All that matters is what the public thinks the bill will do. It's about political propaganda, not about a true concern for the protection of the public's health.

What a sad, sad chapter in federal public health policy making.

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